Manual Usuario Phoenix Gambro (ENG)

Operators Manual
service code 6991376

revision C
rev. sw 3.36
date 2010-02
Manufactured by:
GAMBRO DASCO S.p.A., Via Modenese 66, 41036 MEDOLLA (MO) Italy.
Questions or comments about this publication can be directed to your Local

Representative.
2009-2010 GAMBRO LUNDIA AB. All rights reserved.
PHOENIX is a trademark of GAMBRO HOSPAL (Schweiz) AG registered in: Australia,

Austria, Benelux, Denmark, Estonia, France, Georgia, Germany, Italy, Latvia, Lithuania,
Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, Slovakia,
Slovenia, Sweden, Turkey, United Kingdom, United States and in the European
Community.
PHOENIX is a trademark of GAMBRO LUNDIA AB registered in Canada.

The logo is a trademark of GAMBRO HOSPAL Schweiz AG registered in the
United States.
GAMBRO is a registered trademark of GAMBRO LUNDIA AB.
HOSPAL is a trademark of GAMBRO HOSPAL Schweiz AG and is registered in Algeria,

Austria, Belarus, Benelux, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, China, Croatia,
Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Japan,
Liechtenstein, Macedonia, Monaco, Morocco, Norway, North Korea, Poland, Portugal,
Romania, Russian Federation, San Marino, Slovak Republic, Slovenia, Spain, Sweden,
Switzerland, Ukraine, United Kingdom, United States, Vietnam, Yugoslavia.
Phoenix machine is protected by one or more of the following patents:

US4889635; US5276611; US5111683; US5590237; US5228889; US5567320;
US5895578; US4784495; US5024756; US4798090; US5041215; US5928177;
US5609770; US5394732; US5641144; US6811707; US6881344; US6794194;
US5647984; US5733457; US5650071; US5776091; US5624572; US5618441;
US5629871; US5685835; US5948251; US6003556; US5620608; US6468427;
US6949214; US4740755;
EP0243284; EP0403401; EP0428676; EP0418171; EP0465381; EP0467805; EP0501894;

EP0658352; EP0813880; EP0900093; EP0330892; EP054702; EP0643301; EP0830155;
EP0830156; EP0831945; EP0836486; EP0830153; EP0835493;
CA1327022; CA2032156; CA2208931; CA1286284; CA1282012; CA1308569;

CA1265403; CA2016863;CA1253919;
JP2059115; JP3129326; JP3001235; JP2753242; JP3095223; JP3200594; JP1777042;

JP2542728; JP2823513;
IT1241624; IT01267416; IT01256865; IT01320264; IT01320247; AU595423; BR-

PI8800439-2; KR094404; SE467142; SE465404; TW032116; DE-P3620743.8-35;
DE4031613; FR9014523; GB2239820; MX5077;
Phoenix machine is protected by one or more of the following design registrations:

US-D446861; US-D446860; US-D464060; US-D462698; US-D462362; US-D462696;
DM/051905; DM/055087; IT80564.
Certifications
Indicates that the equipment conforms to Council Directive

93/42/EEC, of 14 June, 1993 relating to Medical Devices.
Also indicates that the notified body which has approved the
manufactures quality system is the British Standards Institution (BSI).
Indicates that the equipment conforms to the rules related to the

Safety of Medical Electrical Equipment for U.S. and Canada.
The C and US indicator adjacent to the CSA mark signifies that
the product has been evaluated to the applicable ANSI/UL and CSA
Standards, for use in the U.S. and Canada.
Only for 115V machine configuration.
REVISION TABLE
Revision C
SECTION PAGES IN REV. C

INTRODUCTION ---
SECTION 1 ---
SECTION 2 ---
SECTION 3 ---
SECTION 4 ---
SECTION 5 ---
SECTION 5A ---
SECTION 5B ---
SECTION 5C ---
SECTION 5D ---
SECTION 5E ---
SECTION 5F ---
SECTION 6 ---
SECTION 7 ---
SECTION 8 ---
SECTION 9 32, 33
WARRANTY ---
APPENDIX A ---
APPENDIX B ---
APPENDIX C
Note
The revision corresponds to page. When the modification is related to a table all the pages
of the table goes on revision.
INTRODUCTION I
INTRODUCTION
IEC Symbols
WARNING: CONSULT ACCOMPANYING DOCUMENTS
TYPE B APPLIED PART

This apparatus provides an adequate degree of protection
against electric shock, particularly regarding allowable LEAKAGE
CURRENTS and reliability of the protective EARTH connection.
OFF (Main power disconnected)
ON (Main power connected)
ALTERNATING CURRENT
PROTECTIVE EARTH (GROUND)
This symbol indicates that:

- the equipment may not be disposed of together with other
municipal waste;
- the equipment was placed on the market after 13 August
2005.
Rev. B
II PHOENIX OPERATOR MANUAL
Keep dry
Year of Manufacturing
Name and address of the Manufacturer
Serial Number
Catalogue Number
Handle with care
This way up
(from IEC 601.1)
Rev. B
INTRODUCTION III
Operator Manual Symbols
WARNING Very important information related to patient or operator

....... safety, or given to avoid machine malfunction. Read
carefully before operating the machine.
NOTE Important information related to the correct functioning

...... of the machine. Read carefully before operating the
machine.
Rev. B
IV PHOENIX OPERATOR MANUAL
INTENDED USE
The PHOENIX Hemodialysis delivery system is intended to be used to provide high
flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing
15 Kilograms or more. The PHOENIX system is to be used with either high or low
permeability dialysers. The device is intended to be used by trained operators when
prescribed by a physician, in a chronic care dialysis facility or acute care unit.
WARNING
Fluid balance deviations, even if within the specified Phoenix accuracy, can
exceed a level that can be tolerated by low-weight patients.
WARNING
The use of procedures not recommended by the manufacturer may result in patient
injury or death. The Manufacturer does not assume responsibility for patient safety
if the procedures described in this manual are not followed carefully and if staff
who perform the procedures have not been appropriately trained and are not
qualified.
WARNING
It is responsibility of the physician to ensure that the appropriate dialyser and
Cartridge Blood Set is selected for the weight of the patient being treated.
WARNING
This manual contains a number of references to accessories and disposables for use
with the Phoenix machine. The Phoenix machine has been tested and validated for
use with the accessories and disposables listed in this manual. The Manufacturer
has not validated the use of accessories or disposables other than those specified in
this manual. The Manufacturer does not assume responsibility or liability for use of
accessories or disposable other than those specified in this manual. It is the
responsibility of the user to validate that other accessories or disposables provide
safe and effective performance.
Rev. B
INTRODUCTION V
SPARE PARTS
Note
The Manufacturer will maintain spare parts availability for ten years after the end of
production of the PHOENIX. At the end of that time the involved product is considered
obsolete and therefore it must be disposed of according to local applicable regulations. The
final user will be informed about spare parts that are no longer available through the
technical service or the commercial representative.
For questions, ask for information from the Local Representative.
WARNINGS
Introduction
WARNING
Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed
a level that can be tolerated by low-weight patients.
WARNING
The use of procedures not recommended by the manufacturer may result in patient
injury or death. The Manufacturer does not assume responsibility for patient safety if
the procedures described in this manual are not followed carefully and if staff who
perform the procedures have not been appropriately trained and are not qualified.
WARNING
It is responsibility of the physician to ensure that the appropriate dialyser and
WARNING
with the Phoenix machine. The Phoenix machine has been tested and validated for use
with the accessories and disposables listed in this manual. The Manufacturer has not
validated the use of accessories or disposables other than those specified in this
manual. The Manufacturer does not assume responsibility or liability for use of
responsibility of the user to validate that other accessories or disposables provide safe
and effective performance.
Rev. B
VI PHOENIX OPERATOR MANUAL
Section 1
WARNING
To operate the machine correctly, pay careful attention to the messages displayed in
the Operator Message Area of the Touch Screen.
WARNING
Check that the alarm lights and audible indicators come on for a short time
immediately after the machine is powered ON (see Section 5.B - Test Procedures, in
this manual).
If either signal is not present, one or both signals have malfunctioned. Call for
service. Do not operate the machine if the alarm safety system is not functioning.
The operator takes full responsibility when a dialysis treatment is carried out in the
absence of the audible and visual alarms.
WARNING
If the two values, stored by the Protection Module, for the same Safety Relevant
parameter are not identical at the time of use, a class Pd alarm is triggered (see
Section 08 Alarms and Signals, in this manual). Modification of a Safety Relevant
parameter may cause a class Pd alarm, since the machine recognizes a change in the
parameter.
This alarm is controlled by the machine in the normal way for class Pd alarms, but
the audible alarm is automatically disabled for 2 minutes.
WARNING
Monitoring of the Venous Pressure could not always detect the disconnection of a
venous needle from its access site, which may result in extracorporeal blood loss to
the environment. When a venous needle disconnects from its access, pressure at the
venous monitoring side may only decrease by the pressure maintained within the
patient's access site. This pressure drop may be less than the width of the machine's
venous pressure alarm window: in this particular case the disconnection of a venous
needle from its access site is not detectable by the machine, even if pressure alarms
and alarm windows are properly set.
To reduce the risk of needles disconnection:
ensure that venous needle and line are firmly secured to the access site area
according to your clinic's protocol;
ensure that the patient's access is visible at all times during the dialysis treatment;
inspect frequently the patient's access;
adjust properly the venous pressure alarm window: the venous pressure alarm
lower limit should be set as closely as practical to the actual patients venous
pressure value without generating excessive nuisance alarms.
Rev. B
INTRODUCTION VII
Section 2
WARNING
Setting of the Configuration environment must be performed exclusively under the
authority of a physician.
The physician is solely responsible for clinical adequacy of the parameters setting.
WARNING
Before confirming a value for a Safety Relevant parameter (refer to 2.1.2 Parameters
List: the Safety Relevant parameters are marked in the Parameters List) make
sure that the value to be confirmed is the same as the value displayed, for that
parameter, in the yellow SAFETY BOX. Confirming a value different from that
displayed in the yellow SAFETY BOX can cause machine alarms related to that
parameter. If you erroneously confirm a value which is different from the value
displayed, for that parameter, in the yellow SAFETY BOX, switch OFF the machine,
wait 5 seconds, then switch ON the machine again.
WARNING
Verify that at least one chemical disinfection process is configured.
WARNING
If the INITIAL BOLUS is set from 0-10 ml, at the Heparin Pump start, the heparin
quantity set is injected automatically as a bolus after which the linear heparinization
starts.
WARNING
This feature must exclusively be used under the authority of a physician, who is solely
responsible for the use of the information processed by the software.
Rev. B
VIII PHOENIX OPERATOR MANUAL
Section 3
WARNING
The user is responsible for checking compliance of Central Concentrate Systems with
the IEC 601.1.1 standard.
WARNING
The user is responsible for the proper connection of the PHOENIX machine to the
Central Concentrate Supply System and to verify proper functioning of this
connection.
WARNING
The three internal lines from the Central Supply Ports on the Rear Panel of the
PHOENIX to the three Front Concentrate Connectors marked 1, 2, 3 are subject to
the same Disinfection requirements as the Central Supply System.
The manufacturer is not responsible for the Disinfection of these lines.
It is the responsibility of the user to carry out Disinfection and Rinse procedures of
these lines, and to:
Check the efficiency of Disinfection.
Perform a mandatory Rinse after Disinfection with chemical agents.
Perform a residual test after Rinse.
WARNING
It is the responsibility of the user to verify that the proper concentrates are used for
the patient. This includes the choice of Acid Concentrate as well as Bicarbonate
Concentrate. The machine, while maintaining all the checks (Conductivity,
Temperature and pH) of Final Dialysate, disables the check on concentrate dilution
that is normally performed when concentrates are provided in containers. The check
on concentrate dilution is disabled when Central Concentrate Supply is used in order
to prevent the occurrence of ! Concentrate Cans #40 alarm.
For further information on the concentrate solutions see Section 9 Specifications,
in this manual.
WARNING
In case of a switch from Central Concentrate Supply to the use of External
Containers, it is the operators responsibility to verify that proper Concentrates are
being used.
WARNING
Containers, if the machine has not been correctly calibrated for the liquid
Concentrates in the External Containers, the ! Concentrate Cans #40 Alarm can
occur. After carefully verifying that the correct concentrates are being used, and that
the dialysate Conductivity is correct, the operator may clear the alarm by performing
the PA and/or PB Autocalibration Procedure (see Section 5.B - Special Procedures for
complete instructions.)
Rev. B
INTRODUCTION IX
WARNING
Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate
Lines, it is advisable to perform a Rinse procedure to avoid chemical reaction or
precipitation due to possible incompatibility of the chemical used with any residual
Acid or Bicarbonate Concentrate that is left in these lines.
WARNING
The efficiency of the Central Bicarbonate Line disinfection process has been tested
and can be guaranteed only if the following conditions are satisfied:
The Central Bicarbonate Line connecting the Rear Connector (3) of the PHOENIX
(See Figure 3.1) to the Central Concentrate Supply system is a PVC line, maximum
3 metres (118.11 in) in length and with an internal diameter of 3 mm (0.118 in),
Sodium hypochlorite solution (active chlorine from 50,000 to 60,000
ppm)/Bleach is used.
WARNING
Before starting a Central Bicarbonate Line disinfection process, it is the operators
responsibility to verify that all the Acid and Bicarbonate connectors are correctly
placed to ensure the disinfection process is properly performed.
WARNING
Before starting a Central Concentrate Rinse process, it is the operators responsibility
to verify that all the Acid and Bicarbonate connectors are correctly placed to ensure
all the lines involved in the Central Concentrate Rinse process are properly rinsed.
Section 4
WARNING
Do not stand on Chemical container shelf.
WARNING
Check the continuity and the reliability of the ground connection.
WARNING
Verify the quality of the protective earth ground at the time of installation.
WARNING
This operation must be performed by authorized personnel. If Service is performed
by unauthorized personnel, the manufacturer cannot accept any responsibility for
any damage which may occur, and such damage is not covered by the warranty.
Rev. B
X PHOENIX OPERATOR MANUAL
WARNING
Do not use this machine near flammable gas or flammable anaesthetic mixtures with
air, with oxygen or with nitrous oxide.
Section 5
WARNING
The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine
has been tested and validated to provide safe and proper functioning of the system.
The Manufacturer has not validated the use of blood lines other than those specified
in this manual. The Manufacturer does not assume responsibility or liability for use of
blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility
of the user to validate that other blood lines provide safe and effective performance.
WARNING
It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal
Before installing a Gambro/Hospal Cartridge Blood Set, carefully read the Cartridge
Blood Set Instructions for Use.
WARNING
Reverse Ultrafiltration of fluid from the dialysate compartment into the blood
compartment may occur when High Flux dialysers are used. Because of their high
ultrafiltration coefficients, high flux dialysers will quickly transfer fluid across the
membrane in response to pressure differences between the dialysate compartment
and the blood compartment.
WARNING
Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if
Single Needle is available on the machine).
WARNING
When the cover of the blood pump is open, verify that the pump is off.
WARNING
Improper connections of the extracorporeal circuit may cause potential patient safety
hazards, that might not be detected by the machine: for instance, hemolysis caused by
kinks, twists, loops, sharp bends, clamps or other restrictions on the blood line, blood
loss to the environment/air into the blood circuit due to leakage in the extracorporeal
circuit.
Rev. B
INTRODUCTION XI
WARNING
Before inserting the venous line in the Air Bubble Detector clean and dry it. Fluid and
gel substances applied on the Air Bubble Detector may reduced the Air Bubble
Detector sensitivity causing patient injury or death. Refer to 6.8.1 External surface
cleaning paragraph, in the Section 06 Clean/Disinfect, for the description of how
to clean the Air Bubble Detector.
WARNING
If bicarbonate dialysis is performed:
1. Do not turn off the machine with bicarbonate dialysate in the flow pathway.
2. It is recommended to perform an acetic acid rinse at least twice a week to remove
the calcium and any precipitate residues, which may be deposited in the hydraulic
pathway.
To do this, follow the instructions for the Disinfection process (see Section 6 -
Clean/Disinfect, in this manual), substituting the chemical disinfectant for an acetic
acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to obtain
400 ml of solution).
WARNING
Ineffective cleaning with acetic acid may cause the machine to malfunction (the lines
or the solenoid valves may block and the sensor readings may be affected).
It is responsibility of the user to check the efficiency of the acetic acid rinsing
procedures and to alter the frequency that they are performed, depending on the
conditions listed above.
WARNING
Check the Expiry date on the BiCart label.
Do not refill the BiCart cartridge.
If required to replace the BiCart when a dialysis treatment is in progress, follow the
BiCart Change procedure in the Section 5.A - Special Procedures, in this manual.
WARNING
If the machine has detected blood at the Patient Sensor during SETUP, the following
message is displayed:
If the line has blood in it, press CONFIRM. Or:
- Remove venous line from patient sensor
- Clean and dry venous line and pt. sensor slot
- Put venous line back in the patient Sensor
- Press CONFIRM
If the patient is already connected to the machine, disconnect the patient from the
machine.
If there is no patient connected to the machine, this BLOOD detection can be
caused by incorrect placement of the venous line. Press the CONFIRM button to
allow the machine to continue.
Rev. B
XII PHOENIX OPERATOR MANUAL
WARNING
DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation
of treatment before dialysate preparation completion, signalled by the appearance of
the following Operator Message:
End Of Dialysate Prep, You Can Proceed
You Can Now Connect The Dialyser
WARNING
When performing dialysis treatment for patients with a body weight of less than 40
kg, special attention should be given to the dialysate flow rate setting. To mitigate the
risk of excessive weight removal, it is recommended to set the DIALYSATE FL.
parameter to a value lower than or equal to 500 ml/min.
WARNING
Verify that fluid is not present in the Waste Handling Option drain port by visual
inspection before inserting the Cartridge Blood Sets priming connector into the port.
If fluid is present in the port for more than six seconds after opening the cover, DO
NOT USE the WHO.
WARNING
Use an aseptic technique when connecting/disconnecting the white priming
connector of the arterial line to/from the WHO in order to avoid any potential
contamination of the line.
WARNING
The Waste Handling Option (WHO) must be cleaned each time blood enters the
WHO drain port before continuing with another patient treatments or once per day
if the WHO has been in use.
(Refer to Section 5.A - Special Procedures, in this manual).
WARNING
Hemolysis may occur if blood comes in contact with disinfectant remaining in the
blood pathway of dialysers that have not been completely rinsed.
If the dialysers are filled with a chemical disinfectant, special rinsing techniques must
be employed to assure the concentration of disinfectant is reduced and maintained
at an appropriate level. These rinsing procedures are the responsibility of the
medical director. The procedures must include a test of residual disinfectant and
techniques to avoid rebound of disinfectant.
WARNING
When selecting SETUP , the limits of the Venous Pressure alarm window are
automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits
are set at -400 to +150 mmHg.
These values are maintained for the duration of the PRIME mode.
WARNING
If performing MANUAL PRIM or PRIME W/O UF , priming of the blood side may be
performed before priming the dialysate side. Dialysate side priming may be started
before blood side priming is complete.
Rev. B
INTRODUCTION XIII
WARNING
If using a dialyser that has been filled with a chemical disinfectant, proceed as
follows:
Verify that the level of residual chemical disinfectant in the extracorporeal circuit
is acceptable according to your facilitys protocol or to the instructions for use of
the disinfectants manufacturer.
When the residual level is acceptable, discard the rinse saline bag and attach a
new bag of saline. If the residual level is unacceptable, proceed according to your
facilitys protocol.
Before initiating dialysis flush the administration set and the entire extracorporeal
circuit with fresh saline according to your facilitys protocol.
WARNING
From the moment that blood is detected in the venous line at the Patient Sensor to
the WASHBACK phase, if the operator stops the Blood Pump pressing the ON/OFF
button on Blood Pump Control Panel:
The venous pressure alarm window lower limit is automatically set to +10 mmHg
and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50
mmHg (see Section 2 - Configuration Description, in this manual).
The arterial pressure alarm window lower limit is automatically set to the value set
for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper
limit is set to +150 mmHg.
These values are maintained for all the time the Blood Pump is OFF and for 30 sec.
after the Blood Pump restart.
WARNING
Once the patient has been connected, do not open the Blood Pump Cover unless it is
required by special procedures described in this manual (i.e., Diaphragm Neutral
Position Procedure); in this case strictly follow these procedures.
Opening of the Blood Pump Cover without following procedures described in this
manual may infuse air to the patient through the arterial line causing patient injury or
death.
WARNING
The PATIENT CONNECT and WASHBACK MODES have associated safety hazards
due to the reduced efficacy of the Protective System; these must be carried out under
the control of the user and are the responsibility of the user.
WARNING
When WASHBACK is selected, the limits of the Venous Pressure alarm window are
automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure
window are set to the value set for the MIN ART PRESSURE parameter increased of
+50 mmHg and +150 mmHg.
These values are maintained for the duration of the WASHBACK mode.
WARNING
When WASHBACK is selected, the heparin pump is stopped.
Rev. B
XIV PHOENIX OPERATOR MANUAL
WARNING
The FILTER CHANGE Action key must be used only when the dialyser needs to be
replaced (Refer to Dialyser replacement in the Section 5.A - Special Procedures in
this manual).
WARNING
Only in the event of the ! Concentrate Cans: A Pump or B Pump or A&B Pumps
(#40) alarm is it possible to perform Autocalibration of PA or PB pump during
DIALYSIS (see Autocalibration procedure for the peristaltic pumps during dialysis
in the Section 5.A - Special Procedures) when the operator accesses the MACHINE
view by pressing the MACHINE Navigation key.
WARNING
In order to verify that the patient has been disconnected properly, the following
message is displayed when the operator presses the EMPTYING Action key the first
time:
WARNING!
Ensure that the patient has been disconnected.
Press CANCEL otherwise.
Press CONFIRM to proceed with emptying.
Press the CONFIRM button on the Main Control Panel to continue. The blood pump
stops and the Protection System is no longer active.
WARNING
In bicarbonate dialysis, it is strongly recommended to perform a descaling of the
hydraulic circuit with vinegar following every treatment. This can be done using the
VINEGAR DESCAL Action key. Its duration may be set with the DESCALING TIME
parameter. During this phase the value of the DESCALING TIME parameter is
displayed.
WARNING
In the case of bicarbonate dialysis, the Acid/Acetate concentrate connector must be
left on the machine so that the DESCALING procedure can be performed.
WARNING
At the end of WASHBACK, if the user does not activate the AutoEmptying procedure,
the blue dialysate connector can be reattached to its bypass port on the machine so
that the dialysate side is emptied through the hydraulic circuit (standard EMPTYING).
WARNING
Follow facility procedures for proper disposal of used Cartridge Blood Set, dialysers,
and other disposables per local regulations.
Rev. B
INTRODUCTION XV
WARNING
Before starting a new dialysis treatment, ensure that the used Cartridge Blood Set
and dialysers have been removed and a new Cartridge Blood Set and dialysers have
been installed.
WARNING
If, after a bicarbonate dialysis, the DESCALING process is partially or completely
skipped by pressing the STOP RINSE Action key, it is strongly recommended to
follow the Precipitate Control (ADR) recommendations provided in Section 06
CLEAN/DISINFECT, in this manual.
Section 5.A
WARNING
Failure to remove the venous line from the Venous Line Clamp can result in rupture
of blood lines or dialyser when hand cranking the Blood Pump.
WARNING
During a power failure, all safety systems of the machine are disabled or are not
operational.
It is particularly important to check that all four clamps in the 4 Position Line Clamp,
above the Blood Pump, are closed in this situation.
WARNING
If a power failure lasts for more than 2 minutes, the patient must be manually
disconnected (see Patient Disconnection section in the Manual).
WARNING
This emergency procedure for Power Failure is applicable only if your Phoenix
machine is equipped with the Battery Backup Kit.
Refer to local representative to verify if your machine is already equipped with the
BATTERY BACKUP Kit.
WARNING
The use of a Fast Recovery of the Dialysis process procedure must be limited to
exceptional cases where the normal recovery procedure can not be performed in
accordance with the standard use of the machine, but where the current dialysis
treatment must be continued.
Rev. B
XVI PHOENIX OPERATOR MANUAL
WARNING
After pressing the SETUP Action key, DO NOT select a dialysate type
(ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine
and the Red and Blue Dialysate Connectors are connected to the dialyser.
WARNING
The Fast Recovery of an interrupted dialysis treatment can only be performed if
TREATMENT has already started (i.e. after PATIENT CONNECT) and has been
interrupted before the EMPTYING mode. This procedure can be performed if the
Patient Sensor has detected blood in the venous blood line and no service processes
(ADR or calibration) have been performed before restarting the dialysis treatment.
WARNING
Do not remove the Blood Pump Segment from the Blood Pump.
Do not remove the venous line from the Air Bubble Detector/Patient Sensor.
WARNING
If the operator erroneously selects a procedure other than SETUP, the Fast
Recovery of the Dialysis process procedure cannot be performed and the patient
must be disconnected.
WARNING
During the time between the machine switching OFF and the next restart of the
interrupted treatment by the +/- buttons selection, all safety systems of the machine
are disabled or are not operational.
WARNING
Note that any treatment parameters that were set for the dialysis treatment are
transient, i.e. they are lost when a Fast Recovery of the Dialysis process procedure is
performed.
Therefore, following a Fast Recovery of dialysis, the only treatment parameters that
are retained are:
for RX dialysis the default data values stored in Rx Config
for Standard dialysis the default data values stored in CONFIG
The only exception are:
for RX dialysis the machine retains the PAT CONN B FLOW parameter value
stored in CONFIG instead of the value stored in Rx Config
for Standard dialysis and RX dialysis the machine retains the DIALYSIS TYPE:
ACETATE/BIC CONC/BICART, set for the current treatment instead of the
DIALYSIS TYPE stored in CONFIG/Rx Config.
NOTE: in case of Computer Prescription of the Treatment (see Section 7 -
Communication System) the restored treatment parameters are:
Dialysis Mode: the last one selected
Dialysis Type: the last one performed by the machine.
Rev. B
INTRODUCTION XVII
WARNING
If during the course of the restarted DIALYSIS, the same problem reoccurs, the cause
is not a temporary malfunction.
The machine must be turned OFF and the patient manually disconnected.
Call for Service.
WARNING
It is the responsibility of the user to determine the correspondence between the
dialysate conductivity, displayed by the machine, and the dialysate solute content,
verified by clinical laboratory results, for each dialysate concentrate used for dialysis
treatment.
This can be done by taking dialysate samples at different conductivity values (e.g.
13,14,15 mS/cm) and sending them to a laboratory for analysis.
WARNING
If switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate
concentrate, both in external containers and delivered from the Central Concentrate
Supply system, it is the operators responsibility to verify that proper 8.4%
bicarbonate concentrate is being used.
WARNING
If a switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate
in external containers, if the machine has not been correctly calibrated for the liquid
Concentrate used, the ! Concentrate Cans #40 Alarm can occur. After carefully
verifying that the correct concentrates are being used, and that the dialysate
Conductivity is correct, the operator may clear the alarm by performing the PB
Autocalibration Procedure (see 5.A.11 Procedure for Autocalibration of the
Peristaltic Pumps during DIALYSIS, in this section, for complete instructions.)
WARNING
Both with Acid/Acetate concentrate container change and with switch from the use
of acid in external containers to the use of acid concentratet delivered from the
Central Concentrate Supply system, it is the operators responsibility to verify that
proper acid/acetate concentrate is being used.
WARNING
Both with an Acid/Acetate concentrate formula change and with a switch from
Central Concentrate Supply system to the use of acid in external containers, if the
machine has not been correctly calibrated for the acid/acetate Concentrate used, the
! Concentrate Cans #40 Alarm can occur. After carefully verifying that the correct
concentrates are being used, and that the dialysate Conductivity is correct, the
operator may clear the alarm by performing the PA Autocalibration Procedure (see
5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS, in
this section, for complete instructions.)
Rev. B
XVIII PHOENIX OPERATOR MANUAL
WARNING
The CONFIRM button, for Dialyser Change, must be pressed only after having
completed the WASHBACK mode.
WARNING
In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration, the user must
always verify that the correct concentrates are connected to the machines
concentrate connectors. When the correct concentrates have been verified the
CONFIRM button must be pressed on the Main Control Panel.
The Autocalibration Process will proceed only after this confirmation.
The use of incorrect concentrates may result in an a incorrect dialysate conductivity,
that may not be detectable by the Protection System.
WARNING
If the ! CONCENTRATE CANS: A PUMP or B Pump or A&B PUMPS #40 alarm
occurs frequently, call for Service.
WARNING
The three Autocalibration Action keys are available only before Dialysate Preparation
is complete.
WARNING
If the Autocalibration Process and the following Test fail, the machine is unable to
acquire the relevant value with sufficient accuracy.
Autocalibration must be repeated or the pump insert changed and then the
autocalibration must be repeated.
If the Autocalibration Process fails, but the following Test passes, the machine
guarantees a degree of accuracy for the value subject to autocalibration.
It is recommended that the Autocalibration Procedure be repeated or the pump
insert replaced.
WARNING
The PA/PB Autocalibration Procedure is mandatory in each of the following cases:
Following a change of the pump insert.
Following a change in the type of concentrate being used.
Following a change from Central Concentrate Supply System to the use of
External Concentrate Containers.
WARNING
Rev. B
INTRODUCTION XIX
WARNING
The alarm system is inactive or impaired when power to the machine or Touch
Screen is off. While manually returning blood, watch the venous line for air. If air is
seen, immediately stop returning blood.
WARNING
Before performing this procedure, ensure that the Cartridge drip chambers are no
more than half full of fluid. Failure to do this may result in patient blood loss.
WARNING
WHO Drain Port before continuing with another patient treatment or once per day if
the WHO has been in use.
WARNING
The patient must not be connected to the machine during this procedure.
WARNING
DO NOT USE this priming connector for patient related uses or any sterile
connections.
WARNING
DO NOT LEAVE undiluted bleach in the flow pathway of the machine.
WARNING
Following the WHO bleach procedure, before performing a Chemical Disinfection
using a chemical other than Bleach, allow the WHO to rinse at least 3 minutes in the
ADR Rinse cycle.
WARNING
DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for
continuation of treatment before dialysate preparation completion, signalled by the
appearance of the following Operator Message:
End Of Dialysate Preparation
WARNING
During OVERRIDE, the operator is responsible for monitoring parameters, which are
being overriden.
Rev. B
XX PHOENIX OPERATOR MANUAL
WARNING
It is the operators responsibility to check that the quantity of heparin delivered to
the patient is enough to prevent blood clots from forming in the extracorporeal
circuit during the transfer of a primed Cartridge Blood Set to another machine.
Section 5.B
WARNING
It is not advisable to continue treatment, but to notify Service as to which test failed.
It is the operators responsibility to carefully check the parameters involved in the
failed test if the decision is made to continue treatment despite the test failure.
WARNING
Notify Service as to which test has failed.
WARNING
During the BUZZER AND LAMP test, the presence of a short audible and visual
signal must be checked (red and yellow lamps illuminated).
If one of the signals is not present, the respective signalling device (buzzer or lamp) is
malfunctioning. Call for Service.
It is NOT recommended to carry out a dialysis treatment in the absence of the
audible and/or visual alarms.
Section 5.C
WARNING
If the BPM is not factory installed, carefully follow the instructions supplied with the
BPM kit.
WARNING
The BPM must be used only for patients with a body weight greater than 15 Kg and
using a BPM cuff of the appropriate size.
Avoid compression or restriction of pressure tubes.
Check (e.g. by observing the limb concerned) that operation of the equipment does
not result in prolonged impairment of the blood circulation of the patient.
The BPM should be tested and calibrated at least once every 4000 hours, or any time
irregular performance is suspected or observed.
Its composition (insulating material) protects the BPM "Applied Part" (Type BF)
against the effect of a defibrillator discharge.
In the event of accidental wetting of the cuff or the hydraulic connections, wipe
immediately to prevent moisture from entering the machine.
Rev. B
INTRODUCTION XXI
WARNING
In order to be in full conformity with the indications of the European Medical Device
Directive 93/42, the manufacturer advises the user that the information originating
from the BPM cannot be used alone as a unique source of information to induce any
therapeutic or pharmacological actions.
Section 5.D
WARNING
It is the responsibility of the operator to check that the numerical values that
represent the Profile (on the bottom of the graph) correspond to the values in the
graph.
WARNING
The physician is responsible for ensuring that the chosen profiles are appropriate for
the patient being treated.
Section 5.E
WARNING
DIASCAN is automatically disabled if:
Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the
operator
Or
Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator
Or
The patient connection is performed before the completion of the initial auto-
calibration.
Or
A Fast Recovery of the Dialysis process is performed
In such cases DIASCAN is inactivated (OFF) for the remainder of the treatment.
WARNING
DIASCAN measurements are not performed if the blood flow is 80 ml/min.
WARNING
For this software version, the accuracy of the DIASCAN Monitoring System is not
guaranteed in the SINGLE NEEDLE mode.
Rev. B
XXII PHOENIX OPERATOR MANUAL
WARNING
The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB
VOLUME, which must be entered and confirmed by the operator. It is the operators
responsibility to assess the clinical validity of these parameters.
WARNING
The physician is responsible for the clinical adequancy of the parameters set for the
correct dialysis dose, based upon the Diascan measurements. Do not use a single
Diascan measurement as the only source of clinical information to initiate
therapeutic or pharmacologic actions (e.g. change in blood flow rate, dialysate flow
rate, dialyser, treatment time, etc...), as unstable operating conditions during a single
DIASCAN measurement may result in an artefact in the values computed from the
individual reading. Therefore, any changes in the dialysis prescription made on the
basis of Diascan analysis should be made in consideration of at least two consecutive
readings.
Section 5.F
WARNING
When the Ultrafilter has been installed, an ADR: RINSING must be performed.
WARNING
For the disinfection of the Ultrafilter it is mandatory to use only the chemical agents
recommended in the DIACLEAR Instructions for Use. They are also compatible with
the PHOENIX Haemodialysis System. The maximum concentration allowed for the
disinfectant used is:
6% Sodium Hypochlorite
4% Peracetic acid
40% Formaldehyde
100% Instrunet
100% Steridial
Refer to the DIACLEAR Instructions for Use.
Some solvents and other chemical products used for cleaning can damage the
DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of
prohibited products.
WARNING
The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the
IDLE view.
Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING to
prime the DIACLEAR.
Rev. B
INTRODUCTION XXIII
WARNING
IDLE view.
Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING cycle
to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or a
DIALYSIS phase.
WARNING
The Ultrafilter Bypass connector MUST be installed when the PHOENIX machine is in
the IDLE view.
When an Ultrafilter Bypass connector has been installed, it is mandatory to perform a
disinfection cycle, before entering a DIALYSIS phase.
WARNING
The following operations must be performed when the machine is in the IDLE view.
WARNING
Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may
cause damage.
WARNING
The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be
performed aseptically, so that the fluid pathway is not contaminated. Perform a
DISINFECTION procedure before patient connection.
WARNING
The DIACLEAR Ultrafilter can only be changed when the PHOENIX machine is in the
IDLE view.
WARNING
It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter
installation.
WARNING
The user is responsible for monitoring the DIACLEAR Ultrafilter working time, by
resetting the DIACLEAR Ultrafilter installation parameters each time a new
DIACLEAR Ultrafilter is installed/replaced, in order to replace the used DIACLEAR
Ultrafilter following the maximum dialysis session directions provided in the
DIACLEAR Instructions for Use.
Rev. B
XXIV PHOENIX OPERATOR MANUAL
Section 6
WARNING
A disinfection process must be followed by a complete RINSING process. If not, on
subsequent SETUP the machine will not allow the selection of the DIALYSIS process.
WARNING
To be compatible with this feature the PHOENIX machine must be retrofitted with
the CWP Adapter kit.
Failure to use the CWP Adapter kit may result in damage to components in the
PHOENIX machine.
WARNING
The temperature of the inlet water to the machine must be lower than 95C (203F).
WARNING
In the Heat Citric phase, it is important that only citric acid is used and no other
disinfectant.
WARNING
Verify the absence of residual disinfectant, before connecting a dialyser.
WARNING
A disinfection process must be followed by a complete RINSE process.
WARNING
For the Touchscreen cleaning use the following disinfectants:
Isopropyl alcohol (70%);
ppm)/Bleach diluted with water at a ratio of 1:50.
WARNING
Do not use chemicals which might damage the plastic parts of the machine.
Avoid chemicals containing benzene, toluene, xylene, acetone or similar solvents.
WARNING
Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid damaging
the metallic parts of this component.
Rev. B
INTRODUCTION XXV
WARNING
Any liquid spilt on the machine must immediately be removed to prevent it from
seeping into the machine.
WARNING
To prevent cross-contamination problems resulting, for example, from blood leakage
from the bloodline or from the dialyser (including blood leak into the hydraulic
circuit) the components listed above must be cleaned by immersing them into a
disinfectant solution or by exposing them except the Concentrate Wands - to a
steam sterilisation procedure (121C for at least 30 minutes).
Careful attention must be paid to dismounting and re-mounting Dialysate
Connectors, Concentrate Connectors and Chemical Connectors in order to avoid
damages to those components and leakages from those components.
WARNING
To prevent damage to the components listed above, do not leave them immersed in
the disinfectant solution for a prolonged period; the proper immersion time is related
to the disinfectant dilution used.
When the dilution is the same as that used in the machine during DISINFECTION,
follow the same time limits:
4 hrs for: Amuchina, Instrunet HD and Sodium Hypochlorite at Disinfectant
strength (1:25 dilution);
24 hrs for: Dialox, Acetoper, Peresal, Actril and Renalin;
48 hrs for: formaldehyde solution and Steridial;
One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution).
(For further information see Section 9 - SPECIFICATIONS, in this Operators
Manual).
WARNING
Stagnant water may contaminate the machine. If machine is stored for more than 7
days, the water line should be disinfected and rinsed.
WARNING
After a prolonged period of storage, Service must be called to return the machine to
proper working order.
Only store at temperatures below 0 C when the hydraulic circuit has been
completely emptied.
Section 7
WARNING
PHOENIX makes available the dialysis related data through connection to various
external devices for storage and display. The intended use of this information is to
support the physicians, but it cannot be considered as the sole data to prescribe any
therapeutic or pharmacological action for the patient. It is the responsibility of the
physician to verify all data.
Rev. B
XXVI PHOENIX OPERATOR MANUAL
WARNING
The present software allows information to be gathered about individuals and the
user must be aware that the use of the information processed or generated by the
software is restricted in most countries by legal dispositions such as the Directive
95/46/EC of the European Parliament and of the Council of 24 October 1995. The
user shall therefore take all necessary measures to ensure the confidentiality of the
information which is monitored by means of the software.
WARNING
The CentryNet system displays on its treatment screens the concentrations for two
conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter. As
the PHOENIX provides only conductivity information (in mS/cm), the CentryNet
entries for Sodium will be approximate values obtained by multiplying the Final
conductivity (mS/cm) by 10. A Final conductivity of 13.6 mS/cm will be recorded in
CentryNet as a Sodium Level of 136 mEq/Liter. Refer to Section 9 Specifications of
this manual for the exact relation between concentration and conductivity.
WARNING
The present SOFTWARE must be used exclusively with the authority of a physician,
who is solely responsible for the use of the information processed by the SOFTWARE.
WARNING
The PHOENIX machine can be programmed by receiving data through connections
to various external devices. As soon as PHOENIX reads the data, it is displayed on
the Touch Screen. It is the responsibility of the user to verify all the data before
confirming it is correct. Some important parameters relating to the safety of the
patient are shown twice, in alternative ways, on the Touch Screen. It is necessary to
pay close attention to these values and check their congruency.
Section 8
WARNING
If more than one alarm occurs at the same time, the control system automatically
prioritizes them, relative to existing alarms.
Only those alarms which describe the presumed cause of malfunction are displayed
in the alarm window.
Alarms that are generated as a result of the original malfunction are not displayed in
the alarm window.
WARNING
The selection of the OVERRIDE button has effect on all the alarms that are active and
can be set to the OVERRIDE state (refer to the Alarms List in this section for the list
of alarms that can be set to the OVERRIDE state). In the Alarm Area of the screen
only two alarm messages can be displayed; if there are more than two alarms active,
the additional alarms may be viewed on the Machine view by pressing the Machine
Navigation key.
Rev. B
INTRODUCTION XXVII
WARNING
During OVERRIDE, the user is responsible for monitoring the parameters that are
being overridden.
WARNING
If the first time the RESTART key is selected, the machine returns to the RESTART
condition, wait at least ten seconds before pressing the RESTART key again.
WARNING
In some Protection alarms, the audible alarm is active only after DIALYSIS is
initiated.
WARNING
Press the RESTART key only after having removed the cause requiring the
RESTART, as described on the Touch Screen. Never press the RESTART key more
than 2 or 3 times if the problem has not been identified that will remove the cause of
RESTART.
WARNING
It is the Operators responsibility to determine and to correct the cause of the
Arterial or Venous Pressure Alarm (#155 and #305) PRIOR to pressing the
OVERRIDE Button.
WARNING
In each alarm condition critical to the safety of the patient (Class P alarms), the
Protection Module checks that the actions relating to the specific safe state are
performed correctly by the machine.
If this test passes, the machine remains in the safe state until the cause of the alarm is
removed (as indicated in the Suggested Action).
Otherwise, i.e. if the safe state is not correctly configured, the Protection Module
generates a > GENERAL SAFE STATE < alarm and the following steps are taken:
The Dialysate Flow through the dialyser is stopped.
The Ultrafiltration Pump is stopped.
The Blood Pump is stopped.
The Venous Clamp is closed.
The machine is stopped and the patient isolated. The operator is warned by:
An alarm window with the message:

> GENERAL SAFE STATE <
An Operator Message in the help window:
You Must Switch Off The Machine
A Visual alarm, with a flashing red light of a 6-2 modulation (two flashes lasting
3/8 of a second with an intervening pause of 1/8 of a second)
A high volume Audible alarm of 6-2 modulation.
Rev. B
XXVIII PHOENIX OPERATOR MANUAL
A numerical code relative to the specific safe state that was not correctly
configured (see below).
The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped. This is
a latching alarm and in order to reset it, the machine must be switched OFF.
If a General Safe State occurs as a result of a T1 test failure, the following message is
displayed:
! T1 TEST FAILED
If a General Safe State is due to incorrect voltage, the following message is displayed:
! Voltages Incorrect
If a General Safe State is due to a Temperature elevated value alarm, the following
! TEMPERATURE EXCESSIVE VALUE
WARNING
When the Blood Pump stops due to an alarm condition:
The venous pressure alarm window lower limit is automatically set to +10 mmHg
and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50
mmHg (see Section 2 - Configuration Description, in this manual).
The arterial pressure alarm window lower limit is automatically set to the value set
for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper
limit is set to +150 mmHg.
WARNING
The machine is supplied with a special device called the Patient Sensor which has the
task of setting some class P alarms in an automatic OVERRIDE state when DIALYSIS
has not yet started, since the patients blood has not yet reached the venous line in
the Patient Sensor.
Therefore, the relevant safety systems are locked until the presence of blood is
detected to allow a smooth start to the process.
This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the
Touch Screen. The Patient Sensor Icons are:
No blood has been detected
Blood has been detected but the operational test has failed. Not all the
relevant safety systems are activated.
Blood has been detected and all the relevant safety systems are activated.
For each Class P alarm, the possibility of an automatic OVERRIDE by the Patient
Sensor and the related effects are indicated, for each alarm in this section, by
highlighting the symbol in correspondence to the safe requests which are active
only after either the Patient Sensor has detected blood in the venous line, or after
the DIALYSIS Action key has been pressed.
Rev. B
INTRODUCTION XXIX
WARNING 1
Do not open the clamp in between the dialyser and the venous chamber (in
DOUBLE NEEDLE mode) or in between the dialyser and the post-dialyser expansion
chamber (in SINGLE NEEDLE mode) because the positive pressure at the blood side
of the dialyser could push air bubbles to the patient.
WARNING 2
RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in
this case the alarm #205 appears).
WARNING
When the patient is connected, if the first selection of the RESTART key doesnt clear
the alarm, re-check carefully all the possible causes of the alarm then press again the
RESTART key. Never press the RESTART key more than 2 or 3 times if the problem
that is causing the RESTART condition has not been identified.
WARNING
If the !Blood Leakage # 28 alarm occurs and the identified cause is Dialyser is
leaking blood into the hydraulic circuit, perform an ADR disinfection before starting
a new dialysis treatment. Presence of blood in dialysate might result in a possible
contamination of the hydraulic circuit with bacteria or viruses. If the ADR disinfection
is not correctly performed before starting a new dialysis treatment, blood into the
hydraulic circuit may cause cross-contamination problems resulting in patient injury or
death.
WARNING
When AC power is interrupted, a continuous audible alarm is turned on.
WARNING
Never press the OVERRIDE button, to clear the ! VENOUS PRESSURE HIGH LIMIT
#154 alarm, if the problem that is causing the alarm condition has not been
identified and removed.
WARNING
Never press the OVERRIDE button, to clear the ! Ven Pressure Alarm #155 alarm, if
the problem that is causing the alarm condition has not been identified and
removed.
WARNING
After patient connection this signal becomes #160, a Class P signal (see Class P
alarms section), which causes a GENERAL SAFE STATE and consequently stops the
machine.
WARNING
It is not advisable to continue treatment, but to notify Service as to which test failed.
It is the operators responsibility to carefully monitor the parameters involved in the
failed test if the decision is made to continue treatment despite the test failure.
Rev. B
XXX PHOENIX OPERATOR MANUAL
WARNING
If the T1 TESTS DISABLED#203 alarm appears, the machine must not be used for a
patient treatment. A Service Technician must re-enable the T1 Tests before using the
machine for a patient treatment.
WARNING
OVERRIDE has no effect if the venous line is not inserted into the Venous Line
Clamp (in which case the alarm number 205: W! Venous Line Not Fitted appears).
WARNING
Never press the OVERRIDE button, to clear the ! Art Pressure Alarm #305 alarm, if
the problem that is causing the alarm condition has not been identified and
removed.
WARNING
Never press the OVERRIDE button, to clear the ! Art Pressure Limit #306 alarm, if the
problem that is causing the alarm condition has not been identified and removed.
WARNING
After the ! UF Mass Balance (#144) recurs 10 times, the TOT. FLUID REMOVED
displayed on video is no more reliable. If an external scale is being used, refer to the
weight measured by the scale to check the value of the TOT. FLUID REMOVED. If an
external scale is not being used, discontinue DIALYSIS.
Section 9
WARNING
Storage under 0C (32F) is not recommended unless the hydraulic circuit has been
emptied (see Maintenance section of the Service Manual).
WARNING
The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic
Compatibility; thus it has an adequate degree of protection against electromagnetic
disturbances.
However, to prevent any problems, it is not recommended to use cellular phones
(hand-held) in the dialysis room or, at least, to keep a minimum distance of 10 m (33
ft) from the equipment.
Refer to, and be compliant with, local standards and guidelines. (For additional
information about special precaution regarding EMC, refer to Appendix A in this
manual).
Rev. B
INTRODUCTION XXXI
WARNING
Possible hazards may arise from equipment (other than the accessories listed below)
being connected to machine, which may cause the permitted leakage current to be
exceeded.
WARNING
The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each
SYSTEM component be individually connected to the main power.
It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET-OUTLETS.
However, if using multiple portable socket-outlets, they must comply with the IEC
60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR.
WARNING
Wait at least 5 seconds after switching OFF the machine before turning it ON again.
WARNING
Do not stand on Chemical Container Shelf.
WARNING
The PHOENIX machine is provided with ports for connecting it with an external
personal computer or a communication network. All external equipments connected
to the PHOENIX machine must be compliant with IEC 60950.
WARNING
Before moving the machine, check that the brake is released and remove infusion
bags or any other weights or hanging objects from the IV pole or from the
concentrate container shelf.
WARNING
It is recommended to use concentrates which conform to the requirements of the
local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of
the European Pharmaceutical standards.
The control of alarm thresholds and dialysate conductivity precision is of major
medical importance in ensuring a safe dialysis treatment.
WARNING
verified by clinical laboratory results, for each dialysate concentrate used for dialysis
treatment.
Rev. B
XXXII PHOENIX OPERATOR MANUAL
WARNING
Attention must be given to the safety hazards related to incorrect choice of dialysate
concentrates.
WARNING
When the conductivity of the dialysate exceeds the alarm threshold, the audible and
visual alarms are triggered.
WARNING
Bicarbonate value in Final Dialysate depends on both the Final conductivity and the
Bicarbonate conductivity settings. It is the responsibility of the user to set
conductivity in accordance with the type of concentrate used to obtain the desired
value of bicarbonate in the final dialysate.
WARNING
Carefully read the BiCart Instructions for Use before using the device. BiCart may
only be used by staff, who are specially trained for haemodialysis treatments, using
the PHOENIX Operators Manual (see Section 5 Dialysis Operation in this
manual).
WARNING
When the temperature of the dialysate exceeds the alarm threshold, the audible and
WARNING
When the pressure of the dialysate exceeds the alarm threshold, the audible and
WARNING
When the pH of the dialysate exceeds the alarm threshold, the audible and visual
alarms are triggered.
WARNING
Contact with cleaning and/or disinfection chemicals may pose a risk of burns, skin
irritation or other adverse reactions. Always follow the chemical manufacturer's
instructions when handling these products or cleaning spills.
WARNING
To prevent damaging the machine, do not leave disinfectant solution in the machine
for periods over the following limits:
Rev. B
INTRODUCTION XXXIII
WARNING
In the Heat Citric Disinfection phase, it is important that only citric acid is used and
no other disinfectants.
WARNING
When the Centralized Heat Disinfection System is used, the temperature of the inlet
water of the machine must be less than 95C.
WARNING
If the difference between the actual flow of the Ultrafiltration Pump and the set UFR
is greater than 20% with a UF Rate greater than 0.2 kg/h, an audible and visual
alarm is triggered. When this alarm is activated the Ultrafiltration Pump is stopped.
WARNING
In the "UF only" process or with the hydraulic circuit in BYPASS, the Blood Leak
alarm may be delayed, due to the operating conditions and dialyser characteristics.
WARNING
Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure and
therefore an alarm may be triggered.
Following a change in the Blood Flow Rate, to prevent such an effect, the Alarm
Window is automatically set wider for 30 seconds. Its lower value is set to +10
mmHg, while the upper limit is set to the VEN PRES LIMIT parameter value
decreased of 50 mmHg (see Section 2 - Configuration Description in this manual).
WARNING
Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and
Window is automatically set wider for 30 seconds. Its lower value is set to the value
set for the MIN ART PRESSURE parameter increased of +50 mmHg, while the upper
value is set to +150 mmHg.
WARNING
the environment. When a venous needle disconnects from its access, pressure at the
patients access site. This pressure drop may be less than the width of the machines
Rev. B
XXXIV PHOENIX OPERATOR MANUAL
WARNING
A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid
blood loss due to coagulation resulting from interruption of blood flow.
WARNING
In WASHBACK (see Section 5 - Dialysis Operation in this manual) the limits of the
Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the
limits of the Arterial Pressure window are set to the value set for the MIN ART
PRESSURE parameter increased of +50 mmHg and +150 mmHg.
WARNING
The Manufacturer has not validated the use of blood lines other than those specified
in this manual. The Manufacturer does not assume responsibility or liability for use of
blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility
of the user to validate that other blood lines provide safe and effective performance.
WARNING
The manufacturer recommends the use of a dialyser with dialysate and blood
connections that comply with ISO 8637.
WARNING
Verify the absence of disinfectant residuals before connecting the dialyser.
WARNING
WARNING
These diameters have been taken from samples from many countries and are correct
at the time of printing. However, the manufacturer cannot be held responsible for
changes in syringe dimensions that may occur. The user should periodically check
the correlation between the stated and the actual diameters.
WARNING
The user must take precautions against the hazard of cross-contamination between
patients by using only extracorporeal circuits with hydrophobic filters on the pressure
ports and by disinfecting the accessible surfaces of the equipment.
Rev. B
INTRODUCTION XXXV
WARNING
Do not remove the panels. If necessary, ask qualified staff to open the panels.
Disconnect the machine from the main power supply before every cleaning,
checking or maintenance operation.
WARNING
Do not use this machine near flammable gas or flammable anaesthetic mixtures with
air, with oxygen or with nitrous oxide.
WARNING
Turn the Blood pump OFF before touching the Blood Pump Rotor. Do not touch the
blocking system.
WARNING
Carefully move the machine by using the handle on the rear panel.
The machine could be damaged if handled in an improper way.
WARNING
Do not assemble, install or use the machine before having read the manual carefully.
WARNING
The manufacturer does not accept any responsibility for damage caused by any
operation carried out on the machine by unauthorized staff.
WARNING
Before replacing or checking any component in the Hydraulic Circuit, a DESCALING
Procedure must performed.
WARNING
Rev. B
XXXVI PHOENIX OPERATOR MANUAL
Warranty
IMPORTANT NOTE
SINCE GAMBRO DASCO S.P.A., THE MANUFACTURER, HAS NO CONTROL
OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS
CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING
TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY, OR THE EFFECT OF
SUCH WORK ON MACHINE OPERATION AND PERFORMANCE, GAMBRO
DASCO S.P.A. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY
DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY
DEVICE, OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE
BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS
BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY.
GAMBRO DASCO S.P.A. DOES NOT RECOGNISE THE OWNER OF A PRODUCT
AS AN AUTHORISED SERVICE REPRESENTATIVE.
THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH
ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE
OWNER WILL BE REIMBURSED BY THE MANUFACTURER.
UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR

INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, ITS LIABILITY
HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT.
THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED

WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR
SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE
MANUFACTURER.
WARNING
with the Phoenix machine. The Phoenix machine has been tested and validated for
use with the accessories and disposables listed in this manual. The Manufacturer
has not validated the use of accessories or disposables other than those specified in
this manual. The Manufacturer does not assume responsibility or liability for use of
responsibility of the user to validate that other accessories or disposables provide
safe and effective performance.
Rev. B
INTRODUCTION XXXVII
Tables of contents
INTRODUCTION ............................................................................................................................ i
IEC Symbols......................................................................................................................... i
Operator Manual Symbols ................................................................................................ iii
INTENDED USE ................................................................................................................... iv
SPARE PARTS ....................................................................................................................... iv
WARNINGS.......................................................................................................................... v
Introduction ............................................................................................................ v
Section 1.................................................................................................................. vi
Section 2.................................................................................................................. vii
Section 3.................................................................................................................. viii
Section 4.................................................................................................................. ix
Section 5.................................................................................................................. x
Section 5.A.............................................................................................................. xv
Section 5.B .............................................................................................................. xx
Section 5.C.............................................................................................................. xx
Section 5.D ............................................................................................................. xxi
Section 5.E............................................................................................................... xxi
Section 5.F............................................................................................................... xxii
Section 6.................................................................................................................. xxiv
Section 7.................................................................................................................. xxv
Section 8.................................................................................................................. xxvi
Section 9.................................................................................................................. xxx
Warranty.................................................................................................................. xxxvi
Tables of contens................................................................................................................. xxxvii
ADDRESSES .......................................................................................................................... xlv
1. GENERAL DESCRIPTION............................................................................................................ 1-1

1.1 Structure of the machine ............................................................................................ 1-1
1.1.1 Therapies Description ................................................................................ 1-1
1.1.2 Structure of the machine........................................................................... 1-2
1.2 Description of the machine........................................................................................ 1-3
1.2.1 Front view ..................................................................................................... 1-3
1.2.2 Rear view ...................................................................................................... 1-6
1.3 Operator interface........................................................................................................ 1-9
1.3.1 Icons representing processes ................................................................... 1-18
1.3.2 HOME icons................................................................................................. 1-20
1.3.3 Pictograms .................................................................................................... 1-21
1.3.3.1 Background shape..................................................................... 1-21
1.3.3.2 List of Pictograms ...................................................................... 1-21
1.4 Parameter Modification .............................................................................................. 1-26
1.5 Monitoring of Venous Pressure and Venous Needle Dislodgement ............... 1-30
Rev. B
XXXVIII PHOENIX OPERATOR MANUAL
2. CONFIGURATION DESCRIPTION .........................................................................................2-1

2.1 Configuration Environment General Description..................................................2-1
2.1.1 Entering Data on the Configuration Environment ...............................2-4
2.1.2 Parameters List.............................................................................................2-6
2.2 CONFIG Views .............................................................................................................2-18
2.2.1 MACHINE Data Configuration ................................................................2-18
2.2.1.1 OPTIONS.....................................................................................2-18
2.2.1.2 COMMUNICATION.................................................................2-20
2.2.1.3 DATE/TIME..................................................................................2-22
2.2.1.4 WAIT TIME ..................................................................................2-23
2.2.1.5 CLEAN DIAL ...............................................................................2-24
2.2.2 CENTER Data Configuration.....................................................................2-25
2.2.2.1 AUTO ...........................................................................................2-25
2.2.2.2 FUNCTION .................................................................................2-26
2.2.2.3 LIMITS...........................................................................................2-27
2.2.2.4 ALARMS.......................................................................................2-28
2.2.3 ADR Data Configuration ...........................................................................2-29
2.2.3.1 CHEMICAL ..................................................................................2-29
2.2.3.2 HEAT.............................................................................................2-35
2.2.3.3 RINSE ............................................................................................2-39
2.2.3.4 AutoStart......................................................................................2-40
2.2.4 Treatment Data Configuration .................................................................2-42
2.2.4.1 STD HD........................................................................................2-42
2.2.4.2 HEPARIN......................................................................................2-46
2.2.4.3 BPM ..............................................................................................2-47
2.2.5 Profiling Configuration ...............................................................................2-48
2.2.5.1 PROFILE General view .............................................................2-48
2.2.5.2 WLR ..............................................................................................2-49
2.2.5.3 Cond .............................................................................................2-50
2.2.6 KT/V Configuration.....................................................................................2-51
2.3 Rx Config Views............................................................................................................2-52
2.3.1 Rx Config General View ............................................................................2-52
2.3.2 Rx Data Configuration ...............................................................................2-53
2.3.3 Rx Add Configuration.................................................................................2-54
2.3.4 Profiling Configuration ...............................................................................2-55
2.3.4.1 PROFILE General view .............................................................2-55
2.3.4.2 UF ..................................................................................................2-56
2.3.4.3 Cond .............................................................................................2-57
2.3.5 Kt/V Configuration......................................................................................2-58
3. CENTRAL CONCENTRATE SUPPLY ........................................................................................3-1

3.1 Specifications.................................................................................................................3-1
3.2 Connection to the Central Concentrate Supply System .....................................3-2
3.3 Operating Instructions.................................................................................................3-4
3.3.1 Switching from Central Concentrate Supply to the use of
External Concentrate Containers .......................................................................3-7
3.4 Central Concentrate Supply Lines Maintenance...................................................3-8
3.4.1 General ..........................................................................................................3-8
3.4.2 Central Bicarbonate Line Disinfection & Rinse: automatic
processes .................................................................................................................3-9
3.4.2.1 Disinfection Procedure.............................................................3-9
Rev. B
INTRODUCTION XXXIX
3.4.2.2 ADR: RINSE following the Central Bicarbonate Line

disinfection................................................................................................ 3-14
3.4.3 Acid and Bicarbonate Lines Rinse: automatic process....................... 3-16
3.4.3.1 Rinse Procedure......................................................................... 3-17
3.4.4 Acid and Bicarbonate Lines Maintenance (Disinfection, Rinse
and Drain): manual procedure ........................................................................... 3-22
3.4.4.1 Adaptor Setup ............................................................................ 3-22
3.4.4.2 Disinfection Procedure............................................................. 3-23
3.4.4.3 Rinse Procedure......................................................................... 3-23
3.4.4.4 Rinse Verification....................................................................... 3-23
3.4.4.5 Draining of Central Concentrate Lines................................. 3-24
4. INSTALLATION............................................................................................................................. 4-1
4.1 Unpacking instructions................................................................................................ 4-1
4.2 Shipping Carton Contents .......................................................................................... 4-1
4.3 Installation ...................................................................................................................... 4-2
4.4 First service .................................................................................................................... 4-4
5. DIALYSIS OPERATION............................................................................................................... 5-1

5.1 Starting ............................................................................................................................ 5-1
5.1.1 Residual Disinfectant Concentration Test ............................................. 5-1
5.1.2 Checking dialysis parameters configuration ......................................... 5-1
5.2 Extracorporeal Circuit preparation ........................................................................... 5-2
5.2.1 Install dialyser............................................................................................... 5-2
5.2.2 Load the Cartridge Blood Set................................................................... 5-2
5.2.3 Fill and install heparin syringe .................................................................. 5-6
5.2.4 Connect saline ............................................................................................. 5-7
5.3 SETUP selection ............................................................................................................ 5-8
5.3.1 Standard Dialysis Mode (when SETUP has been selected)............... 5-10
5.3.1.1 When Acetate Dialysate is programmed in the
Configuration menu................................................................................ 5-10
5.3.1.2 When Liquid Bicarbonate Dialysate is programmed
in the Configuration menu .................................................................... 5-11
5.3.1.3 When BiCart Dialysate is programmed in the
Configuration Menu ............................................................................... 5-13
5.3.2 RX Dialysis Mode ........................................................................................ 5-17
5.4 Preparing for a patient treatment ............................................................................. 5-23
5.4.1 Dialysate preparation ................................................................................. 5-23
5.4.1.1 Possible operations during the dialysate
preparation phase ................................................................................... 5-25
5.4.1.2 Sampling of dialysate ................................................................ 5-25
5.4.2 Priming Mode Selection View ................................................................. 5-26
5.5 Priming of the dialyser................................................................................................. 5-27
5.5.1 Priming with Dialysate Connectors on the Dialyser ........................... 5-27
5.5.1.1 To prime the blood side of the dialyser and the
heparin line ............................................................................................... 5-29
5.5.1.2 To fill the dialysate side of the dialyser................................. 5-31
5.5.2 Priming with Dialysate Connectors on the Rinse Ports...................... 5-32
5.5.2.1 To prime the blood side of the dialyser and the
heparin line ............................................................................................... 5-33
5.5.2.2 To fill the dialysate side of the dialyser................................. 5-35
5.6 Recirculation.................................................................................................................. 5-36
Rev. B
XL PHOENIX OPERATOR MANUAL
5.6.1 Prepare to perform recirculation .............................................................5-36

5.6.1.1 Unclamp lines .............................................................................5-36
5.6.2 Select Recirculation ....................................................................................5-36
5.7 Level adjustment of the Cartridge chambers .........................................................5-37
5.8 Patient Connection.......................................................................................................5-39
5.8.1 Ready for patient connection...................................................................5-39
5.8.2 Heparinization .............................................................................................5-41
5.8.3 Initiating patient connect...........................................................................5-43
5.8.3.1 Fill the extracorporeal circuit with fresh saline prior
to treatment ..............................................................................................5-43
5.8.3.2 Connect patient .........................................................................5-44
5.8.4 Dialysis change mode: Single Needle and Double Needle
mode ........................................................................................................................5-47
5.9 Dialysis ............................................................................................................................5-48
5.9.1 Performing Dialysis .....................................................................................5-48
5.10 End of Dialysis.............................................................................................................5-52
5.10.1 Patient disconnection and Emptying dialyser.....................................5-52
5.10.2 Emptying the dialyser...............................................................................5-54
5.10.2.1 Manual Emptying.....................................................................5-54
5.10.2.2 AutoEmptying...........................................................................5-57
5.10.3 Removing the BiCart ................................................................................5-59
5.10.4 End of Treatment ......................................................................................5-60
5.10.5 Quick Access to the Next Dialysis Treatment....................................5-62
5.A. SPECIAL PROCEDURES .........................................................................................................5.A-1

5.A.1 Emergency procedures for Power Failure...........................................................5.A-1
5.A.2 Emergency procedures for Power Failure with the BATTERY
BACKUP feature ..................................................................................................................5.A-3
5.A.3 Fast Recovery of the Dialysis process ..................................................................5.A-6
5.A.4 Sampling of water from the machine...................................................................5.A-9
5.A.5 Sampling of Dialysate ..............................................................................................5.A-9
5.A.6 Temporary Disconnection of the Patient : PAUSE THERAPY
Procedure ..............................................................................................................................5.A-12
5.A.7 BiCart Change ...........................................................................................................5.A-14
5.A.8 Switching from BiCart Dialysate to the use of Liquid 8.4%
Bicarbonate Dialysate.........................................................................................................5.A-16
5.A.9 Acid/Acetate Concentrate Supply Change ........................................................5.A-18
5.A.10 Dialyser Replacement............................................................................................5.A-20
5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during
DIALYSIS................................................................................................................................5.A-23
5.A.12 Procedure for Standard Autocalibration of the PA, PB, or PUF
Pumps during the Dialysate Preparation Process ........................................................5.A-25
5.A.13 Procedure for Automatic Autocalibration of the UF Pump during
the Dialysate Preparation Process ...................................................................................5.A-28
5.A.14 Manual Disconnection of the Patient................................................................5.A-29
5.A.15 Diaphragm Neutral Position Procedure ............................................................5.A-30
5.A.16 Manual Cleaning procedure for the Waste Handling Option
(WHO) ...................................................................................................................................5.A-32
Rev. B
INTRODUCTION XLI
5.A.17 Transferring a primed Cartridge Blood Set to another PHOENIX

machine for continuation of treatment .......................................................................... 5.A-33
5.A.18 Installation of the Single Needle Holder........................................................... 5.A-36
5.B. TEST PROCEDURES................................................................................................................. 5.B-1

5.B.1 Test procedures.......................................................................................................... 5.B-1
5.C. BLOOD PRESSURE MONITORING SYSTEM................................................................... 5.C-1

5.C.1 General ....................................................................................................................... 5.C-1
5.C.2 Cuff selection............................................................................................................. 5.C-4
5.C.3 Cuff application......................................................................................................... 5.C-5
5.C.4 BPM User interface.................................................................................................. 5.C-6
5.D. PROFILE ..................................................................................................................................... 5.D-1

5.D.1 Introduction............................................................................................................... 5.D-1
5.D.1.1 CURVE TYPE Setting .............................................................................. 5.D-2
5.D.2 Dialysis Mode with Profiling not enabled .......................................................... 5.D-4
5.D.2.1 Display UFR and Conductivity graph in Dialysis Mode with
Profiling not enabled ............................................................................................ 5.D-4
5.D.2.2 DIALYSIS TIME Setting .......................................................................... 5.D-7
5.D.3 Profiled Dialysis Mode ............................................................................................ 5.D-9
5.D.3.1 General ..................................................................................................... 5.D-9
5.D.3.2 Entering the PROFILE View .................................................................. 5.D-10
5.D.3.3 Progressive Curve Profiles .................................................................... 5.D-11
5.D.3.3.1 Conductivity Progressive Curve Profiles:
parameters explanation.......................................................................... 5.D-11
5.D.3.3.2 Ultrafiltration Rate Progressive Curve Profiles:
parameters explanation.......................................................................... 5.D-12
5.D.3.3.3 Programming the Progressive Curve ................................ 5.D-13
5.D.3.4 Step Curve Profiles ................................................................................. 5.D-15
5.D.3.4.1 Ultrafiltration Rate Step Curve Profiles ............................ 5.D-15
5.D.3.4.2 Conductivity Step Curve Profiles....................................... 5.D-16
5.D.3.4.3 Programming the Step Curve ............................................. 5.D-17
5.D.3.5 Modify Profile Parameters .................................................................... 5.D-18
5.D.3.6 Activation of Profile................................................................................ 5.D-21
5.D.3.7 Profile during Dialysis ............................................................................ 5.D-23
5.D.3.7.1 Display Profile during DIALYSIS ........................................ 5.D-25
5.D.3.7.2 Modification of a Curve during DIALYSIS....................... 5.D-29
5.D.3.7.3 Profile during WASHBACK ................................................. 5.D-29
5.D.3.8 Deactivation of Profiling ....................................................................... 5.D-30
5.E. MONITORING.......................................................................................................................... 5.E-1

5.E.1 DIASCAN Monitoring System............................................................................. 5.E-1
5.E.1.1 General....................................................................................................... 5.E-1
5.E.1.2 Parameters................................................................................................. 5.E-4
5.E.1.3 Initial Auto-Calibration ............................................................................ 5.E-7
5.E.1.4 MEASUREMENTS .................................................................................... 5.E-8
5.E.1.5 Operator Interface................................................................................... 5.E-10
Rev. B
XLII PHOENIX OPERATOR MANUAL
5.F. CLEAN DIALYSATE System ....................................................................................................5.F-1

5.F.1 General.........................................................................................................................5.F-1
5.F.2 Ultrafilter information................................................................................................5.F-2
5.F.2.1 DIACLEAR Instruction for Use ..............................................................5.F-3
5.F.3 Installation of the DIACLEAR Ultrafilter on a machine equipped with
the Ultrafilter Bypass connector.......................................................................................5.F-4
5.F.3.1 Removal of the Ultrafilter Bypass connector (old version) ...........5.F-5
5.F.3.2 Installation of the DIACLEAR Ultrafilter .............................................5.F-8
5.F.4 Installation of the Ultrafilter Bypass connector on a machine
equipped with the DIACLEAR Ultrafilter........................................................................5.F-11
5.F.4.1 Removal of the DIACLEAR Ultrafilter..................................................5.F-11
5.F.4.2 Installation of the Ultrafilter Bypass connector (old version) .........5.F-13
5.F.5 Clean Dialysate...........................................................................................................5.F-16
5.F.5.1 Priming/Rinsing of the DIACLEAR Ultrafilter .....................................5.F-16
5.F.5.2 Dialysate Preparation, Priming/Rinsing of the dialyser and
performing the dialysis treatment ......................................................................5.F-16
5.F.5.3 Changing the DIACLEAR Ultrafilter .....................................................5.F-17
5.F.5.3.1 Installation of the new DIACLEAR Ultrafilter....................5.F-17
5.F.5.4 Resetting of the DIACLEAR Ultrafilter Installation
parameters...............................................................................................................5.F-17
5.F.5.5 Chemical Disinfection and Descaling..................................................5.F-18
5.F.5.6 Heat/Heat Citric Disinfection................................................................5.F-18
5.F.6 PHOENIX Operator Interface .................................................................................5.F-19
5.F.6.1 Configuration ............................................................................................5.F-19
5.F.6.2 Icons............................................................................................................5.F-20
6. CLEAN/DISINFECT ......................................................................................................................6-1
6.1 Disinfection ....................................................................................................................6-5
6.2 Chemical Disinfection..................................................................................................6-7
6.2.1 Disinfection...................................................................................................6-7
6.2.1.1 HOW TO PROCEED ................................................................6-7
6.2.1.1.1 List of Parameters and their meanings ................ 6-8
6.2.1.2 HOW TO START THE PROCESS ...........................................6-9
6.2.2 Chemical Disinfection Process in progress ...........................................6-11
6.3 Disinfection with heat (not available on 12 A version)........................................6-12
6.3.1 Heat disinfection .........................................................................................6-12
6.3.1.1 HOW TO PROCEED ................................................................6-12
6.3.1.2 CENTRALIZED HEAT DISINFECTION SYSTEM..................6-14
6.3.2 Heat Citric disinfection ..............................................................................6-15
6.3.2.1 HOW TO PROCEED ................................................................6-15
6.3.3 Heat/Heat Citric Process in Progress (not available on 12 A
version).....................................................................................................................6-18
6.4 Rinsing .............................................................................................................................6-19
6.4.1 Rinsing in progress ......................................................................................6-21
6.5 ADR Action Keys availability......................................................................................6-21
6.6 Verification of the Absence of Residual Disinfectant...........................................6-24
6.7 Water Inlet Line Disinfection .....................................................................................6-25
6.7.1 General ..........................................................................................................6-25
6.7.2 Disinfection Procedure ..............................................................................6-25
Rev. B
INTRODUCTION XLIII
6.8 External Cleaning and Periodic Inspections ........................................................... 6-28

6.8.1 External surface cleaning........................................................................... 6-28
6.8.2 External components Cleaning ................................................................ 6-29
6.8.3 Visual inspection ......................................................................................... 6-31
6.8.4 Storage .......................................................................................................... 6-31
6.8.5 Cartridge Holder O-Rings Inspection and Greasing ........................... 6-32
7. COMMUNICATION SYSTEM................................................................................................... 7-1

7.1 General Description..................................................................................................... 7-1
7.2 Exalis Functional Description ..................................................................................... 7-3
7.3 CONFIGURATION of Communication Environment.......................................... 7-4
7.4 Options of the Communication System.................................................................. 7-8
7.4.1 Patient Login ................................................................................................ 7-8
7.4.2 PRE POST Dialysis data handling. ........................................................... 7-9
7.4.3 Event/Intervention Marking...................................................................... 7-13
7.4.4 Dialysis Report............................................................................................. 7-15
7.4.5 Dialysis Treatment Data ............................................................................ 7-17
7.5 Prescription Download with the Exalis System...................................................... 7-18
7.5.1 General Description ................................................................................... 7-18
7.5.2 Functional Specifications........................................................................... 7-18
7.5.3 Error Messages related to Computer Prescription .............................. 7-19
7.6 Communication Libraries............................................................................................ 7-21
7.7 CentryNet System Connection ................................................................................. 7-22
7.7.1 What CentryNet Does............................................................................... 7-23
7.7.2 How CentryNet Communications Work............................................... 7-24
7.7.3 Operator Tasks and Guidelines for CentryNet .................................... 7-25
7.7.4 Configuring the unit with the CentryNet option ................................. 7-26
7.7.5 CentryNet Option Screen Setup Keys ................................................... 7-29
7.7.6 Communication Icons relating to the state of the network
link............................................................................................................................. 7-31
7.7.7 Operator Keys relating to the state of the treatment ......................... 7-32
7.7.8 Operator Keys relating to manual data collection .............................. 7-35
7.7.9 Alarm signals relating to CentryNet........................................................ 7-36
7.7.10 CentryNet option activation/deactivation after a Fast
Recovery of the Dialysis process ....................................................................... 7-37
8. ALARMS AND SIGNALS ............................................................................................................ 8-1

8.1 Classification and modes of intervention................................................................ 8-1
8.1.1 Operator Guidelines for responding to Alarms on the
PHOENIX machine................................................................................................ 8-6
8.1.1.1 OVERRIDING Arterial and Venous Pressure Alarms ........ 8-7
8.1.1.2 Operator Actions required after pressing the
OVERRIDE Button for Arterial and Venous Pressure Alarms........ 8-8
8.1.2 Alphabetic List of Alarms........................................................................... 8-8
8.2 Numerical List of Alarms and relevant description............................................... 8-20
Rev. B
XLIV PHOENIX OPERATOR MANUAL
9. SPECIFICATIONS .........................................................................................................................9-1
9.1 General specifications .................................................................................................9-1
9.2 Hydraulic section .......................................................................................................... 9-8
9.2.1 Water supply ................................................................................................9-8
9.2.2 Dialysate........................................................................................................9-9
9.2.3 Materials in contact with dialysate, concentrates and water............9-22
9.2.4 Descaling.......................................................................................................9-22
9.2.5 Disinfection...................................................................................................9-23
9.2.6 Ultrafiltration system...................................................................................9-25
9.2.7 Detection of Extracorporeal Blood Loss ................................................9-26
9.2.8 Operating Modes........................................................................................9-28
9.3 Extracorporeal Circulation ..........................................................................................9-31
9.3.1 Operating Modes........................................................................................9-31
9.3.2 Blood Pumps ................................................................................................9-33
9.3.3 Heparin Pump..............................................................................................9-35
9.3.4 Automatic Functions...................................................................................9-37
9.3.5 Main Surveillance Devices ........................................................................9-38
9.3.6 Safety system actuators .............................................................................9-39
9.4 Protection System.........................................................................................................9-40
9.5 General Safety Controls ..............................................................................................9-41
9.6 Technician Maintenance.............................................................................................9-43
WARRANTY ........................................................................................................................................I
A. APPENDIX A: Guidelines and Manufacturers Declaration - Electromagnetic

Emissions and Immunity...................................................................................................................A-1
B. APPENDIX B: Special Troubleshooting ..................................................................................B-1
C. APPENDIX C: Ultrafilter Bypass Connector Installation ....................................................C-1

C.1 Disconnection of the three Ultrafilter Bypass connector lines ..........................C-1
C.2 Connection of the Ultrafilter Bypass connector ....................................................C-9
Rev. B
INTRODUCTION XLV
ADDRESSES
Should you require technical assistance, contact your Local Service Representative as listed
below.
USA
GAMBRO Renal Products, Inc.
10810 West Collins Avenue
Lakewood, CO 80215-4498
Tel. 800 525 2623

303 232 6800
Fax 303 231 4032
CANADA :
GAMBRO Inc.
9157 Champ d'Eau
St Leonard
Quebec H1P 3M3
Tel 514 327 16 35

Fax 514 327 08 22
KOREA :
Gambro Korea Ltd.

Head Office
8th Floor, Hanmi Tower
45 Bangee-dong
Songpa-Ku
KR-SEOUL 138-050
Tel 82 - 2 415 97 72
Fax 82 - 2 424 31 25
Rev. B
XLVI PHOENIX OPERATOR MANUAL
MEXICO :
Gambro de Mexico S.A. de CV

Vasco de Quiroga 1900, Piso 3
MX-Santa Fe
MEXICO D. F. 01210
Tel 52 - 55 52 92 31 00
Fax 52 - 55 52 92 31 13
AUSTRALIA :
Gambro Pty. Ltd. (Sydney)

P.O. Box 6604 BHBC
Baulkham Hills
AU-NEW SOUTH WALES 2153
Tel 61 - 2 9 680 27 11
Fax 61 - 2 9 634 13 75
Rev. B
1 GENERAL DESCRIPTION
1. SECTION 1 - GENERAL DESCRIPTION
1.1 Structure of the machine

PHOENIX is a self-contained, microprocessor-controlled device that provides
haemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the
Haemodialysis Machine in use with a blood tubing set designed for the machine, a
dialyser, a heparin-filled syringe, a BiCart column (sodium bicarbonate powder), and
other appropriate dialysate concentrates.
The machine has many built-in features which are intended to enhance the ease of
providing patient dialysis treatments.
1.1.1 Therapies Description

The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing
set properly designed for the machine, through the dialyser where purification takes
place, and back to the patient.
In the dialyser, the blood and the dialysate fluid flow on opposite surfaces of a thin
semi-permeable membrane. As the blood passes through the filter, the desired
treatment processes take place. Depending upon the therapy in use, the treatment
processes can include fluid removal and/or solute clearance.
The Phoenix machine can carry out the following therapies:
Ultrafiltration
Hemofiltration
Hemodialysis.
Ultrafiltration
In ultrafiltration, the bodys excess fluid is removed through the dialyser membrane by
means of a pressure gradient between the blood and dialysate compartments in the
dialyser.
The entire ultrafiltration process is monitored and controlled by the dialysis machine.
Hemofiltration
In hemofiltration, accumulated metabolic products are removed from blood by the
process of convective transport as a consequence of ultrafiltration of fluid across a
dialyser semi-permeable membrane of high-flux type. The volume of filtered fluid that
exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution
infused into the blood flowpath. The replacement solution adds back some or all of
the water removed, as well as the prescribed solutes. While the dialysis machine
monitors and controls the entire ultrafiltration process, it does not monitor and control
infusion of replacement solution.
Rev. B
1-2 PHOENIX OPERATOR MANUAL
Hemodialysis
In hemodialysis, the chemical composition of blood is corrected by removing
accumulated metabolic products, normalizing ionic content and adding buffer
through the process of diffusive transport.
In this case the concentration of solutes unwanted or to be cleared is lower or null in
the dialysate with respect to the blood, causing these solutes to diffuse from a
compartment of greater concentration (the patients blood) to a compartment of
lesser concentration (the dialysate solution) across a natural or synthetic semi-
permeable membrane.
The bodys excess fluid is removed through the membrane by means of a pressure
gradient created by the dialysis machine.
The entire hemodialysis process is managed by the dialysis machine which monitors
and controls the total ionic composition of dialysate solution together with the
ultrafiltration process.
1.1.2 Structure of the machine

PHOENIX has a modular structure. It is made up of five modules that carry out
independent functions. The modules are described below.
MASTER MODULE
Supervises the functioning of all machine processes. It allows the operator to
communicate with the machine via a colour, touch screen graphical user interface,
through which it is possible to:
select various operations
set parameter values
receive operator and alarm messages
HYDRAULIC MODULE
Supervises the dialysate preparation and the measurement and control of
ultrafiltration.
The PHOENIX is a single-pass system, i.e. dialysate passes through the circuit once.
Dialysate preparation is continuous and its conductivity is determined by the
parameters selected by the operator.
BLOOD MODULE
Manages all the machine processes on the blood side of the extracorporeal circuit.
Arterial blood is withdrawn from the patient, may be mixed with heparin to prevent
coagulation, passed through the dialyser and then is returned to the patient.
The unit consisting of the Master, Hydraulic and Blood Modules is called the Control
System.
PROTECTION MODULE
Manages all processes related to safe operation of the machine and alarm conditions
that occur during dialysis due to unsafe conditions.
The machine reverts to a specific safe state when patient safety is in question.
The machine is fail-safe in the event of a single point failure occurring during
treatment.
BIO MODULE
Manages all processes related to Diascan (see Section 5.E Monitoring, in this
manual).
Rev. B
SECTION 1 - GENERAL DESCRIPTION 1-3
1.2 Description of the machine
1.2.1 Front view
(For machines with Serial Number greater

than PH25160 the Patient Card reader is
not available.)
Rev. B
Machine Components Front View
(A) Patient Card Reads the Patient Card. (For machines with Serial Number greater
Reader than PH25160 the Patient Card reader is not available.)
(B) Display/ Allows the operator to communicate with the PHOENIX
Haemodialysis Delivery System via colour Touch Screen and control
Touch Screen
buttons.
(C) Main Control A panel of buttons whose functions allow the operator to access and
Panel modify parameters, mute or reset/override alarms. An additional
button, the SAFE button (CURRENTLY NOT AVAILABLE), can be
programmed with any combination of the following: stop the blood
pump, bypass the dialyser, or enter minimum UFR. HEART button
(initiates a blood pressure measurement), HELP button (CURRENTLY
NOT AVAILABLE) and EVENT/INTERVENTION (CURRENTLY NOT
AVAILABLE) button.
(D) Blood Pump A panel of buttons that allows the operator to control blood pump
Control Panel functions: turn blood pump on/off, resume blood pump speed and
decrease/increase blood pump speed.
(E) 4-Position Line Plastic assembly that holds the four access lines extending from the
Clamp top of the Cartridge Blood Set. The four clamps are colour coded for
correct line placement as follows: Green-heparin line; Red (right)-
arterial access line; Red (left)-cartridge saline line; Blue-venous access
line.
(F) Blood Pump A plastic cover that protects the blood pump from foreign objects
Cover and Cover and provides a track inside the cover to hold the pump segment of
Latch the Cartridge Blood Set on the pump rollers. The cover latch keeps
the blood pump cover closed during operation and the Cartridge
securely in place over the arterial and venous pressure sensors. The
blood pump will not run unless the door is securely latched.
Blood Pump Pumps blood through the extracorporeal circuit.
(G) Air Bubble Ultrasonic sensor that detects macro and micro air in fluid/blood
Detector within the venous line. If macro or micro air is detected, an ! AIR &
FOAM DETECTOR alarm (number 4) occurs (blood pump stops and
Patient Sensor
venous line clamp closes). The infra-red Patient Sensor detects the
presence of blood in the venous line. When blood is detected the
Protection Module is fully activated.
(H) Arterial Line Clip Secures arterial line to the machine.
(I) Venous Line Occlusive clamp that closes the venous line during certain red-light
Clamp alarms, some self-tests, and when power is off. Prevents blood flow
to the patient.
(J) WHO (Waste Connects a WHO priming connector on the Cartridge Blood Set to a
Handling drain port to dispose of waste fluids produced during priming.
Option)
(K) Acid/Acetate Connects to a container of acid concentrate (for bicarbonate
Line (red haemodialysis) OR acetate concentrate (for acetate haemodialysis).
connector) and The acid/acetate line is connected to its red rinse port during rinse
Rinse Port and storage.
Rev. B
(L) Bicarbonate Line Connects to a container of bicarbonate concentrate. The bicarbonate

(blue connector) line is connected to its rinse port when a BiCart is in use, when the
and Rinse Port machine is used for acetate dialysis, and during rinse and storage.
(M) Disinfectant Line Connects to a chemical container used during the machine chemical
(yellow processes. During the main machine phases it must be connected to
connector) and its rinse port.
Rinse Port
(N) Concentrate Located on bottom front; holds containers of liquid concentrates
Container Shelf needed for haemodialysis therapy.
(O) Locking Brake Prevents the machine from moving when in use.
(P) Heparin Syringe Holds the barrel of the heparin syringe.
Holder
(Q) Heparin Control Panel of two buttons that move the plunger clamp to ( ) or away
Panel ( ) from the syringe plunger.
(R) Heparin Syringe Holds the plunger of the heparin syringe; moves horizontally to push
Plunger Clamp heparin into the blood flow path at the specified rate.
Heparin Pump Controls the rate of heparin delivery into the blood flow path.
(inside machine) Heparin can be delivered continuously or in bolus amounts.
Blood Leak Infrared light detector that detects red blood cells in the dialysate
Detector (inside leaving the dialyser. Blood in the dialysate indicates a leak or tear in
machine) the dialyser membrane. If blood is detected, a Blood Leak alarm
(#28) occurs (blood pump stops and venous line clamp closes).
(S) BPM Cuff Houses the BPM cuff when not in use.
Holder
(T) Blood Module Secures the blood module panel (middle third of front panel). The
Panel Latch latch can be opened with a hex key. Only Service technicians should
open the latch (to service the internal blood module components).
(U) Main Power Turns machine power On/Off. The label I means ON and the label
Switch / Circuit O means OFF. The switch is also a circuit breaker and shuts off
Breaker power in the event of an internal electrical overload. The breaker can
be reset by turning the machine OFF, then ON.
(V) BiCart Holder Holds a BiCart (powdered bicarbonate cartridge) for bicarbonate
dialysis. The holder arms open to allow a BiCart to be inserted
Note: Bicarbonate concentrate in a container can be used for
bicarbonate dialysis instead of BiCart, if desired.
Rev. B
1.2.2 Rear view
Rev. B
Machine Components Rear View
(A) Solution Bag Hooks Holds containers of IV solutions for administration through the
Cartridge Blood Set.
(B) IV Pole Adjustment Loosens/tightens to adjust and hold the IV pole at the desired
Knob height.
(C) IV Pole Adjusts up/down for convenient placement of IV solutions.
(D) Status Lights Illuminate to give a general indication of operating conditions.
Yellow A flashing yellow light indicates:
one or more alarms have been overridden;
a low priority alarm has occurred, for example, the machine is
operating in Bypass or Minimum UFR. Immediate patient
safety is not compromised, but the operator should investigate.
Red A flashing red light indicates a high priority alarm has occurred, for
example the machine has detected air in the venous line or blood
in the dialysate line. A condition of possible patient or machine
hazard exists, the operator should intervene immediately. The
flashing red light will be displayed in the event of a general safe
state condition.
(E) Ultrafilter Detection Detects the presence of the Diaclear Ultrafilter.
Switch
(F) Hour Meter Accumulates hours of full power operation. Hours spent in low
power are not counted on the meter.
Depending on the machine version, the Hour Meter can be
located either on the left side of the Ultrafilter Bypass Connector
(as shown in the Figure) or in the Computer Interface Panel (see
Figure 9.0 in the Section 09 Specifications).
(G) Computer Interface Provides ports for PHOENIX options including connection to
Panel external networks.
(H) Ultrafilter Bypass A connector linking the ultrafilter lines when the Diaclear
Connector Ultrafilter is not being used.
(I) BP Tubing Connects luer lock on tubing of the PHOENIX BP Monitor to the
Connector internal electronic module.
(J) Air Vents Provide continuous ventilation of interior components.
(K) Blood Pump Crank Crank fits on the blood pump rotor, allowing manual blood return
to the patient, if necessary.
(L) Cable Holder (for Holds the power cable when the machine is being moved or not
storage of being used.
equipment)
(M) Wand Holder Stores the concentrate wands and the conductivity sampler when
they are not being used.
(N) Chemical Container Holds containers of liquid chemicals needed for ADR procedures.
Shelf
(O) Power Cord The power cord is permanently attached.
(P) Inlet Water Hose Connects to the facilitys water supply and carries water to the
machine.
Rev. B
(Q) Drain Hose Connects to the facilitys drainage system and carries away used
dialysate, ultrafiltrate, and other waste fluids.
(R) Dialysate Line From Carries used dialysate from the dialyser. During the hydraulics
Dialyser (red portion of T1 TEST, ADR procedures, and storage, this line must
connector) and be connected to its bypass port.
Bypass Port
(S) Dialysate Line To Carries fresh dialysate to the dialyser. During the hydraulics
Dialyser (blue portion of T1 TEST, ADR procedures, and storage, this line must
connector) and be connected to its bypass port.
Bypass Port
(T) Cartridge Holder Accepts the Cartridge Blood Set and secures it in position with the
Cartridge clip (on the left) and the blood pump rotor (on the right).
Has two pressure transducers with sealing cones for pressure
monitoring. The red cone connects with the arterial chamber; the
blue cone connects with the venous chamber.
(U) Dialyser Holder Holds the dialyser. Consists of a movable arm and two grippers
attached to the machine.
(V) Inlet Water Filter Inlet Water Filter Standard (250 m).
Rev. B
1.3 Operator interface
General description
The PHOENIX operator interface consists of:
A colour Touch Screen display that shows:

parameters and commands which the operator can select
alarm messages
operator messages
status icons and pictograms
Navigation keys to access different views on the Touch Screen.
During normal operation, the Touch Screen has the following configuration:
1 2 3 4
TIME RX /PATIENT NAME AREA ALARM AREA STATUS AREA
AREA
5 6 7
BPM AREA OPERATOR MESSAGE AREA PICTOGRAM AREA
10 9 12
ARTERIAL/VENOUS PARAMETER AREA ACTION
8 SELECTION
PRESSURE BAR GRAPHS OPERATION IN PROCESS
I KEYS
AND VIEW DISPLAY
C
O
N
A
R
E 11
A BLOOD PUMP
SPEED FLOW AREA
14. 13. NAVIGATION KEYS

HOME
1. Time Area: displays the current time of day.

2. Rx/Patient Name Area: displays the therapy or name of the patient selected
through personalised dialysis treatment procedures.
3. Alarm Area: in the event of any alarm, an alarm message window, which contains
both the name and the number of the alarm, will appear in this area. The alarm
messages are the current active alarms that are occurring on the machine or the
most significant, if more than 2 are occurring. If there are more than 2 alarms, the
additional alarms may be viewed on the Machine view by pressing the Machine
Navigation key.
4. Status Area: one message is displayed to describe the current status of the
machine.
Rev. B
5. BPM Area: displays the last systolic and diastolic blood pressure and the heart rate
as measured by the Blood Pressure Monitor. Moreover it displays the time of the
last BPM measurement.
6. Operator Message Area: displays the operations that need to be carried out or
messages regarding the status of the machine.
7. Pictogram Area: displays a visual indicator of machine state/operation. (see
Pictograms in this section)
8. Icon Area: displays the icons that represent current feature/option enabled. (see
Icons representing processes in this section)
9. Parameter Area: displays parameters appropriate to the operation in process and
view displayed.
10.Arterial/Venous Pressure Bar Graphs: displays current arterial and venous
pressures.
11.Blood Pump Speed/Flow Area: displays current blood pump speed and
compensated blood flow rate.
12.Action/Selection Key Area: displays Action keys used to start each specific
operation and Selection keys for selection menus.
13.Navigation Keys Area: used to access each available Touch Screen view.
14.HOME Navigation Key Area: displays the HOME Navigation Key icon. (see
HOME icon in this section)
WARNING
To operate the machine correctly, pay careful attention to the messages displayed
in the Operator Message Area of the Touch Screen.
Note
Some Action keys and parameters appearing on the Touch Screen are currently not available.
In this manual they are described as CURRENTLY NOT AVAILABLE.
Note
Format of time representation is user settable in Configuration environment. Format of
time representation in this manual is only for reference.
a Main Control Panel below the Touch Screen:
Or
Rev. B
a Blood Pump Control Panel above the Blood Pump:
a Heparin Control Panel above the Heparin Pump:
The buttons located on the Main Control Panel are called FUNCTION BUTTONS:
MUTE button used in an alarm condition to silence the audible

alarm (see Section Alarms and Signals).
OVERRIDE/RESET button used in an alarm condition to

override/reset an alarm (see Section Alarms and Signals).
SAFE button allows the user to put the machine in the safety state
customized by the facility in Configuration. (CURRENTLY NOT
AVAILABLE)
or
HELP button (CURRENTLY NOT AVAILABLE)
HEART button: Initiates a BPM measurement outside of the

automatic interval. Pressing the HEART button initiates a blood
pressure measurement.
EVENT/INTERVENTION button: Allows the user to mark a

patient event/intervention and store it in the system memory.
(CURRENTLY NOT AVAILABLE)
See Section 7 - Communication System in this manual for a
detailed description.
SET button is used to enter the Set Mode
set
CONFIRM button. Used to confirm and store the values selected

or actions requested.
PLUS and MINUS buttons increase/decrease the parameter

values when the parameter has been selected in Set mode and it
has a numeric value.
The buttons located on the Heparin Pump Control Panel are called HEPARIN PUMP
Function buttons:
Rev. B
ARROW LEFT and ARROW RIGHT buttons are used to position

the heparin syringe plunger clamp against or away from the
syringe plunger. Placement of this clamp against the syringe
plunger is very important to ensure accurate delivery of heparin.
The buttons located on the Blood Pump Control Panel are called BLOOD PUMP Function
buttons:
ON / OFF button is used to start the blood pump at the preset
start value or to stop it when it is running.
Note: When the Blood Pump is stopped due to an alarm
condition, the ON / OFF button is not active.
RESUME button is used to restart the blood pump at the previous
set value or to restart the blood pump after an ! Air & Foam
Detector alarm (#4).
PLUS and MINUS buttons are used to change the blood pump
speed
The green Led on the ON / OFF button can be ON, OFF or flashing depending on
the machine operating conditions.
The Led is ON:
When the Blood Pump is running;
In SN dialysis, during both the arterial and the venous phases of the
cycle;
When the Blood Pump is stopped due to an alarm condition.
The Led is OFF:
When the Blood Pump is stopped by using the ON / OFF button;
When a machine phase, in which the Blood Pump is running, is
stopped due to an operator intervention (for example Recirculation
phase stopped due to the selection of the RECIRC Action key).
When a machine phase, in which the Blood Pump is running, has
been correctly completed (for example the programmed RINSEBACK
VOLUME value has been reached).
The Led is Flashing:
When the Blood Pump speed is controlled by the machine and can
not be changed by pressing the PLUS and MINUS buttons (i.e. during
the Automatic Gradual Ramping).
Note
An audible signal (an high tone followed by a low tone) triggers, following the selection of
a button, when:
The machine has not been temporarily able to detect correctly the button previously
selected; in this case wait at least 5 seconds before pressing again a button to let the
machine recognize the selection made.
A superimposed window is present on the Touchscreen and the selection of that
particular button is not requested by the superimposed window.
The PLUS and MINUS buttons are pressed but a manual increment/decrement of
the blood pump speed is not possible in that machine phase.
Rev. B
Operating modes
When the machines ON/OFF switch is turned ON the software program is loaded. It
takes a few minutes for the machine to become fully operational. The progress and
the successful completion of the software loading process can be seen on the Touch
Screen.
WARNING
Check that the alarm lights and audible indicators come on for a short time
immediately after the machine is powered ON (see Section 5.B - Test Procedures, in
this manual).
If either signal is not present, one or both signals have malfunctioned. Call for
service. Do not operate the machine if the alarm safety system is not functioning.
The operator takes full responsibility when a dialysis treatment is carried out in the
absence of the audible and visual alarms.
Note
If the Touch Screen turns black or white during the software loading process, a temporary
machine malfunction has occurred. Switch OFF the machine, wait 5 seconds and then
switch ON the machine again.
At the end of the software loading process, the Idle view is displayed on the Touch
Screen indicating which procedures are available to run.
12:30
IDLE
PATIENT DATA
SETUP
ADR
BPM REPORT CONFIG RX MACHINE
CONFIG
Each view is referred to by its Navigation key name. The pictogram displayed in the
upper right hand corner of the touch screen indicates the current status of the
machine.
The operator can choose which procedures to run as described in the following
sections of this Operators Manual.
For each process/procedure, the specific function of each ACTION key is explained
as well as the operations to be carried out.
Rev. B
At Power ON, information related to the status of the last machine process, correctly
completed or interrupted just prior to the machine Power OFF, is displayed on the
Touch Screen.
Depending on the process, some of the following Icons and relevant Help Messages
may appear on the Touch Screen in the Parameter Area, as listed below:
Acetate Dialysis Completed h:min day/month/year

(1) NO ICON
Bicarbonate Dialysis Completed h:min day/month/year
(1) NO ICON
BiCart Dialysis Completed h:min day/month/year
(1) NO ICON
Acetate Dialysis h:min day/month/year
User Stop Phase XX
(See Note 1)
Bicarbonate Dialysis h:min day/month/year
or
(1) User Stop Phase XX
(See Note 1)
or BiCart Dialysis h:min day/month/year
User Stop Phase XX
(See Note 1)
Acetate Dialysis h:min day/month/year
Alarm message (if present) Phase XX
or
(See Note 2)
Bicarbonate Dialysis h:min day/month/year
or or Alarm message (if present) Phase XX
(1)
(See Note 2)
or BiCart Dialysis h:min day/month/year
(See Note 2)
or or
Rinsing Performed Correctly h:min day/month/year
(1)
Rinsing not Performed Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
Chemical Proc. Performed Correctly h:min day/month/year
(1)
Chemical Proc. NOT Performed Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
Heat Proc. Performed Correctly h:min day/month/year
(1)
Heat Proc. NOT Performed Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
Rev. B
Heat CWP Proc. Performed Correctly h:min day/month/year

(1)
Heat CWP Proc. NOT Performed Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
Heat Citric Proc. Performed Correctly h:min day/month/year
(1)
Heat Citric Proc. NOT Performed Correctly h:min day/month/year

(1) User Stopor
(See Note 3)
Rinse+Bicarb Line Performed Correctly h:min day/month/year
(1)
Rinse+Bicarb Line Not Perf. Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
CCK Lines Rinse Performed Correctly h:min day/month/year
(1)
CCK Lines Rinse NOT Performed Correctly h:min day/month/year

(1) User Stop or
(See Note 3)
Chem+Bicarb Line Proc. NOT Perf. Correctly h:min day/month/year
(1) User Stop or
(See Note 3)
Process AutoStart Enabled
(2) RINSING or
HEAT or
HEAT CWP or
CHEMIC. 1 or
CHEMIC. 2 or
CHEMIC. 3 or
CHEMIC. 4 or
H. CITRIC
Failure of the[test failed]Test h:min day/month/year
(3) New Session Feature not Allowed
(See Note 4)
Failure of the[test failed]Test h:min day/month/year
(3) (See Note 5)
SETUP not Allowed. To allow SETUP remove connector from

(4) NO ICON Central bicarb port and reinsert if needed
(See Note 6)
SETUP not Allowed. A Disinf. Process
(5) NO ICON Must be performed to allow SETUP
(See Note 6)
Rev. B
Note
Format of date representation in the Help Messages displayed at the machine power ON
is user settable in Configuration environment. Format of date representation in the above
table is only for reference.
Note 1
This message is displayed in case of dialysis treatment interrupted during dialysate
preparation or priming phase due to an operator intervention. Along with the Help
message on the type of dialysis interrupted, are also displayed the message informing that
an user stop caused the dialysis treatment to be interrupted, the time and the machine
operating phase in which the dialysis treatment has been interrupted.
Note 2
This message is displayed in case of machine Power OFF following dialysate type
selection. Along with the Help message on the type of dialysis interrupted, are also
displayed the first alarm message that was displayed in the Alarm Area (if present) before
machine Power OFF; the time and the machine operating phase in which the dialysis
treatment has been interrupted.
Note 3
This message is displayed in case of ADR process interrupted due to an operator
intervention or in case of machine Power OFF during an ADR process. Along with the
Help message on the type of ADR process interrupted, are also displayed the reason that
caused the ADR process to be interrupted (user intervention or the first alarm message
that was displayed in the Alarm Area before machine Power OFF); the time and the
machine operating phase in which the ADR process has been interrupted.
Note 4
This message is displayed in case of failure of one of the following T1Tests: Temperature,
Cond A, Cond B and BLD.
Note 5
This message is displayed in case of failure of one of the following T1Tests: Board CPU,
EPROM CRC, Comparator, Battery, Voltages (24V), Venous Clamp, Electrovalves, Art/Ven
Pressure, Blood Pump, PI/PO Pressures and Ultrafiltration Pump.
Note 6
Refer to Section 3 Central Concentrate Supply, in this manual, for the detailed
description of the CCK Bicarbonate Line Disinfection and of the CCK Acid and
Bicarbonate Lines Rinse.
Rev. B
The above Help Messages appears on the Touch Screen in the Parameter Area, in the
following order:
12:30
IDLE
Messages related to the completion of a process. PATIENT DATA

In the above table are indicated as (1)
Message related to the Autostart feature.
Line Not Used
Line Only for Service use SETUP
Messages related to the T1Tests failure.

Message related to the completion of the Central Bicarbonate Line Rinse.
Message related to the completion of the Central Acid and Bicarbonate Lines ADR
Rinse. In the above table are indicated as (5)
BPM REPORT CONFIG RX MACHINE
CONFIG
For information about the Dialysis process refer to Section 5 Dialysis Operation; for
information about the ADR Cycle refer to Section 6 Clean/Disinfect, for information
about the CCK Bicarbonate Line Disinfection and about the CCK Acid and
Bicarbonate Lines Rinse refer to Section 3 Central Concentrate Supply in this
manual.
Rev. B
1.3.1 Icons representing processes

The icons relating to particular machine processes or alarms are listed below:
The Patient Sensor, positioned on the venous line in the Air

Bubble Detector housing, has not detected the presence of
blood.
Bubble Detector housing, has detected the presence of blood
and all machine safety systems are activated.
Bubble Detector housing, has detected the presence of blood or
there is a failure of the congruency test. Not all machine safety
systems are activated.
Linear heparinization has been selected.
The Heparin Pump is performing a linear heparinization.
Automatic bolus heparinization has been selected.
The Heparin Pump is performing an automatic bolus

heparinization
Manual bolus heparinization has been selected.
The Heparin Pump is performing a manual bolus heparinization.
The Total Fluid Removed is at least 100 g more than the Total
Fluid Removed forecasted for that time. The UFR value
suggested for recovery is shown in the SET Mode, selecting the
UFR parameter.
The Total Fluid Removed is at least 100 g less than the Total
Fluid Removed forecasted for that time. The UFR value
suggested for recovery is shown in the SET Mode selecting the
UFR parameter.
The BPM device has been activated (automatic mode)
A BPM measurement (manual or automatic) is in progress
BY-PASS. The machine is in bypass and dialysate flow is diverted

from the dialyser.
Rev. B
A transmembrane pressure alarm is present and a negative TMP

condition exists.
Diascan is active and calibrated
Diascan autocalibration in progress

A Diascan measurement (manual or automatic mode) is in
progress
Diascan is present but not working
The machine is configured for use of the Patient Card.

(This icon is not currently displayed)
Conductivity Profiling has been activated.
UF Profiling has been activated.
Conductivity and UF Profiling have been activated
CentryNet option has been deactivated.
CentryNet option is active but communication between the

network controller and the machine does not occur.
CentryNet is active and effective communication is in progress.

When there are records to be taken by the CentryNet network
controller this icon flashes until the controller has successfully
taken all records.
Waiting/reading data.
In the description of each process, these icons will not be not shown. Please refer to
this Section for their description.
Rev. B
1.3.2 HOME icons

The icons displayed in the HOME Navigation key Area are listed below:
HOME Navigation key icon selected.
HOME Navigation key icon not selected.
HOME Navigation key icon selected in Set mode.
Rev. B
1.3.3 Pictograms
1.3.3.1 Background shape
Different shapes are used for each pictogram.

The shapes and their meanings are listed below:
Alert: this shape is used to draw the operator's attention to an

alarm or warning situation.
Transitory Status: this shape means the machine has been put in
a temporary situation after an operator action. The operator has
to respond to exit this status.
Out of Treatment: this shape means "out of treatment process"
In Treatment: this shape means "in treatment process".

Treatment starts when the operator initiates the preparation and
ends after the FINAL RINSE.
1.3.3.2 List of Pictograms
Idle: the machine is waiting for an operator action
Rinsing: the machine is performing a RINSING process.
Rev. B
Heat Disinfection/Heating: the machine is performing a heat

disinfection. The heating phase or the temperature sustained
phase is in progress.
Heat Disinfection/Cooling: the machine is performing a heat

disinfection. The Cooling phase is in progress.
Heat Citric Disinfection/Heating: the machine is performing a

Heat Citric disinfection. The heating phase or the temperature
sustained phase is in progress.
Heat Citric Disinfection/Cooling: the machine is performing a

Heat Citric disinfection. The cooling phase is in progress.
Chemical Disinfection: the machine is performing a Chemical

disinfection.
Dialysate Preparation & Test: the machine is performing the

dialysate preparation and the functional test is in progress.
Dialysate Preparation & Test completed: the machine is

performing the dialysate preparation and the functional test is
completed.
Dialysate Preparation & PA or PB or PUF Autocalibration: the

machine is performing the dialysate preparation and the PA or
PB or PUF Autocalibration.
Rev. B
Dialysate Preparation ended awaiting Priming: the machine

has completed the dialysate preparation and is waiting for an
operator action to start priming.
Dialysis Priming without UF: the machine is performing dialyser

priming without UF; only the blood side priming is started.
or
Manual Priming: the machine is performing the manual priming
of the dialyser.
Dialysis Priming with UF: the machine is performing dialyser

priming with UF; the blood side and the dialysate side are filled.
Dialysate Priming of dialyser: the machine is rinsing the

dialysate compartment first; only the dialysate side is filled.
(This pictogram is not currently displayed)
Priming ended awaiting Recirculation: the machine has

completed the priming phase and is waiting for an operator
action to start Recirculation.
(This pictogram is not currently displayed)
Diascan Autocalibration: Diascan autocalibration is in progress.
Dialysate Recirculation: the machine is performing

RECIRCULATION.
End Priming, awaiting Patient Connect: the machine has

completed priming and is waiting for an operator action to start
patient connection.
Rev. B
Patient Connection: patient connection is in progress.
Dialysis: treatment is in progress.
Single Needle Dialysis: Single Needle dialysis is in progress.
Pause Therapy: The PAUSE THERAPY Action key has been

selected for a temporary disconnection of the patient during
treatment.
WASHBACK: WASHBACK is in progress.
Dialyser Emptying/Autoemptying: The dialyser emptying

process is in progress.
Descaling: The machine is performing the DESCALING process

with acid or vinegar solution after EMPTYING.
Rinsing: FINAL RINSE is in progress.
Rev. B
Warning: warning yellow lamp.
Alarm: alarm red lamp.
Set: SET MODE.
Select: selection menu.
In the description of each process, these pictograms will be not shown. Please refer to
this Section for their description.
Rev. B
1.4 Parameter Modification

All significant parameters for the current process appear in the view chosen on the
Touch Screen. In order to modify parameter values, the operator must first press the
SET button on the Main Control Panel.
By pressing the SET button on the Main Control Panel, the SET MODE is activated
and a view that has all parameters available for modification will appear as shown
below:
12:30
IDLE
Parameter Name Parameter Name Parameter Name Parameter Name
Parameter Value Parameter Value Parameter Value Parameter Value

Unit of Measure Unit of Measure Unit of Measure Unit of Measure
Min Max Min Max Min Max Min Max




HOME (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1)
Note
The Navigation keys change according to the Config category selected.
At this point it is possible:
To select a specific parameter to be modified by touching the parameter box on

the Touch Screen.
To increase or decrease the value by using the PLUS and MINUS buttons on the
Main Control Panel.
To select a different parameter for modification by touching that parameter box on
the Touch Screen.
Once the desired value for the parameter has been reached, press the CONFIRM
button on the Main Control Panel to accept and store the value in memory. Each
parameter must be confirmed individually.
Rev. B
A yellow SAFETY BOX appears in the lower right hand corner of the Touch Screen
when a Safety Relevant parameter has been selected for modification (refer to Section
02 Configuration Description, in this manual: the Safety Relevant parameters are
marked in the Parameters List).
Press the SET button a second time when the parameter modification has been
completed to exit the SET MODE and to return to the current process view.
The machine will exit the SET Mode automatically if the elapsed time without a key or
button being pressed exceeds the value set for the TO VIDEO parameter. The length
of this timeout may be programmed in the Configuration menu.
Note
30 seconds is the default interval. The value range is selectable from 10 to 90 seconds (for
more details see Section 2 - Configuration Description, in this manual).
The parameter value displayed during normal operating processes is the same as the
current value.
Note
If the operator selects a Safety Relevant parameter for modification (refer to Section 02
Configuration Description, in this manual: the Safety Relevant parameters are marked
in the Parameters List), the parameter being modified is shown in two places: it appears
on the Touch Screen in the usual position and it appears in the yellow SAFETY BOX in the
lower right hand corner of the Touch Screen.
Carefully check the two values to make sure they are the same.
The duplicate image in the yellow SAFETY BOX disappears as soon as the value is
confirmed.
Pressing CONFIRM allows the Protection Module to accept the value displayed in the
yellow SAFETY BOX and store it in two different memory locations.
WARNING
If the two values, stored by the Protection Module, for the same Safety Relevant
parameter are not identical at the time of use, a class Pd alarm is triggered (see
Section 08 Alarms and Signals, in this manual). Modification of a Safety Relevant
parameter may cause a class Pd alarm, since the machine recognizes a change in
the parameter.
This alarm is controlled by the machine in the normal way for class Pd alarms, but
the audible alarm is automatically disabled for 2 minutes.
Rev. B
Setting Alarm Limits for ARTERIAL, VENOUS, SN MAXIMUM and SN

MINIMUM PRESSURE.
The arterial and venous pressures appear on separate pressure bar graphs. An alarm
limit window, rather than a specific value, is selected for each pressure and it is
displayed on the colour coded (red = arterial, blue = venous) bar graph. The alarm
limit window can be selected in the following ways:
ARTERIAL / VENOUS PRESSURE

The negative and positive pressure alarm limit window:
can be confirmed by selecting the colour coded area on the graph in Set mode
and then pressing the CONFIRM button on the Main Control Panel.
can be adjusted by selecting the colour coded area on the graph in Set mode, by
pressing the PLUS (increase high/low limit) and MINUS (decrease high/low limit)
buttons to move the alarm limit window to positive/negative pressure values and
then by pressing the CONFIRM button on the Main Control Panel.
The minimum (low venous pressure) limit of the alarm window corresponds to a value
40 mmHg less than the confirmed venous pressure value.
The maximum (high venous pressure) limit of the alarm window corresponds to a
value 70 mmHg greater than the confirmed venous pressure value.
The minimum (low arterial pressure) limit of the alarm window corresponds to a value
100 mmHg less than the confirmed arterial pressure value.
The maximum (high arterial pressure) limit of the alarm window corresponds to a
value 100 mmHg greater than the confirmed arterial pressure value.
In Single Needle dialysis, the limits are +10 mmHg and the value set for the VEN PRES
LIMIT parameter in Config/Centre Conf/Treat.Conf, respectively.
Note
In Single Needle dialysis, the value set for the VEN PRES LIMITparameter has to be the
same as the value set for the SN Pparameter to avoid the ! Ven Pressure Limit #154
Alarm occurrence.
SN MAXIMUM and SN MINIMUM PRESSURE (Single Needle transition pressure)

The SN P and SN P parameters control the cycling of the single needle transition from
the arterial phase to the venous phase. These minimum/maximum pressure values are
selected using the PLUS (increase maximum) and MINUS (decrease minimum)
buttons.
Store values by pressing the CONFIRM button on the Main Control Panel.
Note
Following adjustment of the blood pump speed, the machine automatically recognizes
the new venous and arterial pressure value, created by the change in the blood pump
speed.
Rev. B
Note
The venous pressure window limit is automatically set to between -50 and +250 mmHg:
In PRIME and WASHBACK
After the RESUME button selection in case of! Air & Foam Detector alarm (#4).
The arterial pressure window has a range of -400 mmHg to +150 mmHg;
Setting BLOOD PUMP SPEED

This value is set from the Blood Pump Control Panel, using the PLUS (increase) or
MINUS (decrease) buttons on the Blood Pump Control Panel.
Note
Adjustment of the blood pump speed may lead to venous and arterial pressure
fluctuations and a venous pressure/arterial pressure alarm may be triggered.
To prevent this, for 30 seconds following a change in the blood pump speed:
The venous pressure alarm lower limit is automatically set to +10 mmHg and the
upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg
(see Section 2 - Configuration Description, in this manual).
The arterial pressure alarm lower limit is automatically set to the value set for the
MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to
+150 mmHg.
Note
If the blood pump speed is set to zero by the operator, the machine will automatically set
the UFR to its minimum value.
When the blood pump speed is reset to a value greater than zero, the UFR returns to the
value set by the operator.
Note
Calculation of the BLOOD FLOW in SN mode may be done by using the blood pump
activation time and the blood pump speed:
Blood Pump Speed x TART

BLOOD FLOW =
TCYCLE
TART = Active time of Blood pump
TCYCLE = Cycle time (activation + deactivation)
Rev. B
1.5 Monitoring of Venous Pressure and Venous Needle

Dislodgement
The Phoenix hemodialysis machine is provided with a venous pressure monitoring
system able to trigger an alarm condition in case that the patient venous pressure falls
below the venous pressure alarm threshold set by the operator (Refer to the Setting
Alarm Limits for ARTERIAL, VENOUS, SN MAXIMUM and SN MINIMUM
PRESSURE paragraph in this Section for the description of how to set the alarm limits
for venous pressure).
User has to be aware that venous pressure monitoring system is not always able to
detect the pressure drop caused by a venous needle dislodgement. This particular
situation is described in the literature1
To reduce the risk related to a Venous Needle Dislodgement event, carefully follow
the guidelines below:
1. Ensure that the venous needle and the venous line are adequately fixed to the
patient according to your facility's protocol.
2. Make sure that the patient's access is visible at all times during the dialysis
treatment. Do not cover the access with clothing, blankets, linens.
3. Visually inspect the patient's access frequently for needle security and site
bleeding. Pay a special attention to patients who are moving a lot during the
dialysis treatment.
4. Recommend patient to inspect its access site frequently.
5. Properly adjust the venous pressure alarm windows. In particular, it is
recommended that the lower venous alarm limit is set as close as possible to the
actual value of the patient venous pressure.
WARNING
venous needle from its access site, which may result in extracorporeal blood loss to the
environment. When a venous needle disconnects from its access, pressure at the
patient's access site. This pressure drop may be less than the width of the machine's
adjust properly the venous pressure alarm window: the venous pressure alarm lower
limit should be set as closely as practical to the actual patients venous pressure value
without generating excessive nuisance alarms.
1
Sandroni S. Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic
hemorrhage. Hemodialysis International (abstract) 2005; 9: 33-34.
Medical Device Safety Reports. Undetected venous line needle dislodgement during hemodialysis.
Health Devices 1998; 27: 404-406.
Rev. B
2 CONFIGURATION DESCRIPTION
2. SECTION 2 - CONFIGURATION DESCRIPTION
2.1 Configuration Environment General Description

Before carrying out a dialysis process, the operator can set the parameter values to be
used during dialysis entering the Configuration environment.
This may be done by selecting, from the IDLE View, the Config Navigation key or the
Rx Config Navigation key (in case of individual prescription parameters configuration
Patient/Rx keys will individualize a particular prescription parameters configuration).
12:30
IDLE
BPM REPORT KT/V PROFILE CONFIG RX MACHINE

CONFIG
Rev. B
When the Config Navigation Key is pressed, the following view is displayed:
12:30
IDLE
CONFIG MACHINE CENTRE ADR TREATMENTS PROFILE KT/V

CONF
Rev. B
SECTION 2 - CONFIGURATION DESCRIPTION 2-3
When the Rx Config Navigation Key is pressed, the following view is displayed:
12:30
IDLE
1ST PATIENT
2ND PATIENT
3RD PATIENT
4TH PATIENT
5TH PATIENT
6TH PATIENT
7TH PATIENT
RX
CONFIG
The user can navigate through the views grouping all the configuration parameters of
the machine by using the Navigation keys: pressing each Navigation key allows the
user to access the parameters related to the designated function, allowing
customization of machine performance.
Note
Both the Config and the Rx Config Navigation Key are only available when the machine is
in the IDLE mode.
Rev. B
2.1.1 Entering Data on the Configuration Environment
WARNING
Setting of the Configuration environment must be performed exclusively under the
authority of a physician.
The physician is solely responsible for clinical adequacy of the parameters setting.
In the next paragraphs all the views of the Configuration environment, with
corresponding parameters are described.
The following procedure must be followed to modify machine parameters:
After selecting the Navigation key for the parameters to be modified, a view with the
following structure is displayed:
12:30
IDLE
PARAMETER NAME PARAMETER NAME
NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1
Note 1
The Navigation keys vary depending on the selection made from the Configuration
environment.
Note
The number of parameters displayed in the Parameter Area can be variable.
A list of all the parameters related to the Navigation key pressed is displayed in this
view. Each parameter appears on the parameter area in a double column
representation.
Rev. B
The operator may modify any parameter value by pressing the SET button on the
Main Control Panel.
When the SET button is pressed, the SET Mode is activated and the view will change,
as shown in the example below:
12:30
IDLE
PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME

PARAMETER PARAMETER PARAMETER PARAMETER
VALUE VALUE VALUE VALUE
UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE
MIN MAX MIN MAX MIN MAX MIN MAX
VALUE VALUE VALUE VALUE SAFETY
PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER BOX
UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE
MIN MAX MIN MAX MIN MAX
VALUE
UNIT OF MEASURE
MIN MAX
At this point it is possible:
To select a parameter by touching the parameter box area.
To change a parameter with a numeric value by using the PLUS and MINUS
buttons on the Main Control Panel. These buttons are used to modify the desired
value for a parameter within a fixed range.
Once the desired value has been reached, pressing the CONFIRM button on the
Main Control Panel accepts the value and stores it in memory.
To change a parameter with a string value: after touching the parameter box
area, a new view appears with a list of all the values for that parameter. This view
has the same form as the previous one: the possible values for the parameter are
located in parameter boxes, by touching these areas the operator selects the
desired value. The parameter box corresponding to the current value for the
parameter selected is yellow highlighted.
Once the desired value has been selected, pressing the CONFIRM button on the
Main Control Panel accepts the value and stores it in memory.
To move from one parameter to another by pressing a different parameter box

area.
Rev. B
The SAFETY BOX, a yellow second box, appears when a Safety Relevant parameter
has been selected (refer to 2.1.2 Parameters List for a list of all the Safety Relevant
parameters: the Safety Relevant parameters are marked in the Parameters List).
WARNING
Before confirming a value for a Safety Relevant parameter (refer to 2.1.2 Parameters
List: the Safety Relevant parameters are marked in the Parameters List) make
sure that the value to be confirmed is the same as the value displayed, for that
parameter, in the yellow SAFETY BOX. Confirming a value different from that
displayed in the yellow SAFETY BOX can cause machine alarms related to that
parameter. If you erroneously confirm a value which is different from the value
displayed, for that parameter, in the yellow SAFETY BOX, switch OFF the machine,
wait 5 seconds, then switch ON the machine again.
Press the SET button again when parameter modification has been completed: the
previous view appears.
Note
All the parameters may be seen on the Configuration views, but their values can no
longer be modified.
Note
The previous parameter selection view may be accessed again by pressing the SET button
on the Main Control Panel.
Note
After modifying a parameter value in the CONFIGURATION environment and before
switching off the machine, wait at least 5 seconds to avoid a failure in the data storage.
Note
In the following paragraphs, a list of all the available parameters in their proper view is
presented.
2.1.2 Parameters List

Below is an alphabetic list of all the parameters, with their respective limits or possible
values, which may be verified by the operator.
Note
set
The parameters marked may not be changed by the operator. Their values are
automatically calculated by the machine.
Note
The parameters marked are Safety Relevant parameters.
Rev. B
PARAMETER VALUE UNIT

1st PROC NONE/RINSING/HEAT/HEAT
First process that can be programmed for the CWP/CHEMIC. 1/CHEMIC.
Cleaning Autostart. 2/CHEMIC. 3/CHEMIC. 4/H.
CITRIC
2nd PROC NONE/RINSING/HEAT/HEAT

Second process that can be programmed for CWP/CHEMIC. 1/CHEMIC.
the Cleaning Autostart. 2/CHEMIC. 3/CHEMIC. 4/H.
CITRIC
3rd PROC NONE/RINSING/HEAT/HEAT

Third process that can be programmed for the CWP/CHEMIC. 1/CHEMIC.
Cleaning Autostart. 2/CHEMIC. 3/CHEMIC. 4/H.
CITRIC
ACETATE DIAL USE YES/NO

Enables/disables the use of the Acetate
Dialysis mode.
AUTO OFF YES/NO
Enables/disables automatic Power OFF
following RINSE.
ART P From the value set for the MIN mmHg
Arterial pressure alarm threshold. ART PRESSURE parameter
increased of 100 to +50
BPM USE YES/NO/AUTOMATIC
Enables/disables use of BPM (accessory in
Patient dialysis mode). YES turns on BPM , NO
turns off BPM, AUTOMATIC allows BPM
readings to start automatically with the
initiation of Dialysis.
AUTO OFF YES/NO
Enables/Disables automatic Power OFF
following ADR processes.
AUTOCHART TIME 00:00 to 01:00 in steps of 00:15 h:min
Sampling time used by the machine to
automatically acquire records for
CentryNet/Exalis
AUTOEMPTYING YES/NO
Enables/disables the use of the Autoemptying
procedure at the end of a DIALYSIS.
BAUD RATE 1200; 2400 ; MEMORY CARD;
Speed of the data transmission 9600
BEEP ON TOUCH YES/NO
Enables/disables the generation of a loud beep
for all user actions.
BIC 6.6% COND 4.6 to 6.0 in steps of 0.1 mS/cm
Bicarbonate conductivity value when the 6.6%
formulation is used
BIC 8.4% COND 2.7 to 3.7 in steps of 0.1 mS/cm
Bicarbonate conductivity value when the 8.4%
formulation is used.
BICARB CONC 6.6/8.4 %
Type of bicarbonate concentrate formulation.
BICART DIAL USE YES/NO
Enables/disables the use of the BiCart Dialysis
mode.
BICART COND 2.7 to 3.7 in steps of 0.1 mS/cm
BiCart conductivity value.
Rev. B

BLD SENS LOW/HIGH
Sensitivity level of the Blood Leak Detector to
the presence of blood in dialysate.
BLOOD FLOW set 10 to 580 in step of 10 ml/min
Blood flow value.
BOLUS INTERVAL 00:05 to 02:00 in steps of 00:05 h:min
Time interval between each Heparin Bolus.
CCM IDENTIF 1 to 255 in step of 1
Machine identification number for
communication with CCM.
CENTR BICARB LINE set YES
Selection of the Central Bicarbonate Line
Disinfection process.
CLEARANCE ALA. YES/NO
Enables/disables clearance alarm.
CLEARANCE LEVEL 50 to 300 in steps of 5
Threshold value for clearance alarm
SW COMM SYSTEM Exalis/CentryNet /Rims / Other /
Selection of the software system to which the None
machine will be connected.
CON CURVE TYPE PROGRESSIVE/STEP/CONSTANT
Selection of the Conductivity curve type in
Profiling.
COND STEP 13.0 to 17.0 in steps of 0.1 mS/cm
Conductivity value for the conductivity step.
CONDUCTIVITY 13.0 to 17.0 in steps of 0.1 mS/cm
Final conductivity value.
COOLING set YES/NO
Execution of the cooling phase after the heat
disinfection.
CURVE COEFF 20 to 80 in step of 5 %
Percentage of the rate of change in Cond or
UF during Profiling.
DATE DISPLAY MODE dd/mm/yyyy
Format of Date representation. dd/mm/yy
mm/dd/yyyy
mm/dd/yy
dd mmm yyyy
dd mmm yy
mmm dd yyyy
mmm dd yy
DAY 1 to 31 dd
Current day (calendar context)
DAY NAME Monday/Tuesday/Wednesday/Thu
Name of the current day (calendar context) rsday/Friday/Saturday/Sunday
DELTA WEIGHT 1 to 20 Kg
Difference between patient weight pre and
post dialysis.
Depurated Vol set 0 to 200 l
Volume of body water purified during
DIALYSIS.
DESCALING TIME 03:00 to 10:00 in step of 01:00 min:s
Length of time for rinsing with an acidic
solution after EMPTYING (Bicarbonate
dialysis).
DIAL AUTO PRIME YES / NO
Enables/disables the priming mode selectable
during dialysate preparation.
Rev. B

DIALYSATE FL. 350 to 800 step of 50 ml/min
Dialysate flow rate during DIALYSIS.
DIALYSIS TYPE ACETATE/BIC CONC/BIC BICART
Type of dialysate concentrates configured for
DIALYSIS.
INIT DIAL B FLOW 50 to 580 in step of 10 ml/min
Blood pump speed at the initiation of
DIALYSIS.
DIFFUSION TIME set From the value set for the h:min
Time remaining until the end of DIALYSIS. DIALYSIS TIME parameter to
Time is stopped when the machine is in 00:00
BYPASS or when the blood pump stops.
DIAMETER 13.0 to 25.0 in step of 0.1 mm
Heparin syringe diameter
DIASCAN YES/NO
Enables/disables use of the Diascan feature in
DIALYSIS.
DIASCAN USE YES/NO
Use of Diascan as accessory.
DISINF TIME chemical disinfection: 15:00 to min:s
Duration of disinfection process. 30:00 or
28:00 to 43:00 in steps of 00:10
if END PROCESS MODE is set
Bact.
heat disinfection (not available on
12A version):18:00 to 36:00 in
steps of 18:00 min or 20:00 to
40:00 in steps of 20:00 if the
DIACLEAR Ultrafilter is installed.
heat citric disinfection: 24 min or
28 min if the DIACLEAR Ultrafilter
is installed.
DRY WEIGHT 8.0 to 200.0 in steps of 0.5 Kg
Patients dry weight for the Volume calculation
in Diascan.
END DIALYSIS TWL/TIME/ T BL/DIFF. TIME
End point of the DIALYSIS treatment.
END DIA DATA set REQUESTED
End dialysis data transferring mode
END PRE ALARM YES/NO
Enables/disables alarm at the end of dialysate
preparation.
END PROCESS MODE None/Bact. / Rins.
Enables the ending mode of the Chemical or
Heat citric process.
END DIA ALARM YES/NO
Enables/disables alarm at the end of DIALYSIS.
INCIDENT
Patient event occurring during dialysis
EXT SYNCHRO 00:00 to 01:30 in steps of 00:05 min:s
Timeout used at the switch on to detect the
network presence.
EXTERNAL JUG USE YES/NO
Enables/disables use of external jugs for
chemical processes.
FINAL RINSE TIME set From 01:00 to 00:00 min:s
Time remaining until the end ofFINAL RINSE.
Rev. B

FINAL VALUE 13.0 to 17.0 in step of 0.1 mS/cm
Conductivity at the end of treatment for the
COND profiling curve.
GATEWAY 0 to 255 in steps of 1
Parameter for Internal use.
GATEWAY 2nd 0 to 255 in steps of 1
GATEWAY 3rd 0 to 255 in steps of 1
GATEWAY 4th 0 to 255 in steps of 1
HEART Rate set 40 to 180 pulse
Measurement of heart rate.
HEPARIN BOLUS 0.0, 0.5 to 10.0 in steps of 0.1 ml
Volume of bolus injected automatically.
PRIMING HEP YES/NO
Enables/disables automatic priming of heparin
line duringSETUP.
HEPARIN RATE 0.5 to 9.9 in step of 0.1 ml/h
(in linear heparinization mode)
HEPARIN ALARM YES/NO
Enables/disables alarm if heparin has not been
activated at the start of DIALYSIS.
END HEP ALARM YES/NO
Enables/disables alarm at the end of heparin
administration
PRE STOP TIME 00:00 to 04:00 in step of 00:05 h:min
Time between the end of heparin
administration and the end of DIALYSIS.
HEPARIN TYPE LINEAR/AUTO BOLUS/MAN
Heparin infusion mode in DIALYSIS. BOLUS/NONE
HOURS 0 to 23
Hours (calendar context)
INITIAL BOLUS 0.0 to 10.0 in steps of 0.1 ml
Initial heparin bolus (before the linear
heparinization mode)
INITIAL VALUE 0.10 to 4.00 in step of 0.01 Kg/h
Initial value for UF Profiling curve
INITIAL VALUE 13.0 to 17.0 in step of 0.1 mS/cm
Initial value for COND Profiling curve
INSTALL TIME set 0 to number of days elapsed from days
Days elapsed from installation of the DIACLEAR DIACLEAR Ultrafilter installation
Ultrafilter counted from the selection of the
CLEAN DIAL Action key.
INTAKES 0 to 1000 g
Food or fluids given during DIALYSIS.
INTERMEASUREM 00:00 to 01:00 in steps of 00:15 h:min
Interval between two clearance
measurements.
IONIC CLEARANCE set 0 to 300 ml/min
The average effective Clearance of ionized
substances.
KT/V set 0 to 3.00
Dialysis Dose (on Monitoring Graphs).
Ionic Mass Bal set -500 to 800 mmol
Mass Balance of ionized substances.
Rev. B

IP ADDRESS 1st 0 to 255 in steps of 1
First part of the TCP/IP Configuration
Addresses of the unit in case of Ethernet
connection.
IP ADDRESS 2nd 0 to 255 in steps of 1
Second part of the TCP/IP Configuration
connection.
IP ADDRESS 3rd 0 to 255 in steps of 1
Third part of the TCP/IP Configuration
connection.
IP ADDRESS 4th 0 to 255 in steps of 1
Fourth part of the TCP/IP Configuration
connection.
BIC LIQUID DIAL USE YES/NO
Enables/disables the use of Liquid Bicarbonate
Concentrate.
LIQUID INLET FRONT/REAR 1/REAR 2
Identifies the inlet port location for the
disinfectant used in the chemical disinfection
process.
TOTAL BLOOD 0.5 to 360.0 in steps of 0.5 l
Total blood treated during treatment.
MANUAL BOLUS 0.0, 0.5 to 10.0 in steps of 0.1 ml
Heparin bolus amount for manual bolus
administration.
MASK ROUTE1 0 to 255 in steps of 1
MASK ROUTE1 2nd 0 to 255 in steps of 1
MASK ROUTE1 3rd 0 to 255 in steps of 1
MASK ROUTE1 4th 0 to 255 in steps of 1
MAX BLOOD FLOW 250 to 580 in steps of 10 ml/min
Maximum Blood Flow.
DIAST PRE MAX 35 to 250 in steps of 5 mmHg
Maximum diastolic pressure alarm.
HEART R. MAX 45 to 250 in steps of 5 pu/min
Maximum pulse rate alarm.
SYST PRE MAX 55 to 270 in steps of 5 mmHg
Maximum systolic pressure alarm.
VEN PRES LIMIT 200 to 450 in step of 50 mmHg
Max venous pressure limit.
HD SAFE THRE. 350/450 mmHg
Alarm threshold on dialyser transmembrane
pressure.
SAMPLE INTERV (BPM) 00:05 to 02:00 in step of 00:05 h:min
Time between 2 blood pressure
measurements.
MED QUANTITY
Medicine quantity/dosage administered during
DIALYSIS.
MEDICATION
Medicine/s administered during DIALYSIS.
MIN ART PRESSURE -400 to -100 in step of 50 mmHg
Minimum arterial pressure limit.
Rev. B

DIAST PRE MIN 20 to 235 in steps of 5 mmHg
Minimum diastolic pressure alarm.
HEART R. MIN 30 to 235 in steps of 5 pu/min
Minimum pulse rate alarm.
SYST PRE MIN 40 to 255 in steps of 5 mmHg
Minimum systolic pressure alarm.
TMP THRESHOLD -100 to +10 in steps of 5 mmHg
Alarm threshold on dialyser transmembrane
pressure.
WLR MINIMUM 0 to 0.300 in steps of 0.100 Kg/h
Minimum fluid removal rate.
MINUTES 0 to 59 min
(calendar context).
MONTH January//December month
(calendar context).
NET ROUTE1 0 to 255 in steps of 1
NET ROUTE1 2nd 0 to 255 in steps of 1
NET ROUTE1 3rd 0 to 255 in steps of 1
NET ROUTE1 4th 0 to 255 in steps of 1
NETWORK TYPE Serial/Ethernet
Selection of the hardware network topology.
NEW SESSION USE YES/NO
Enables/disables the use of the New Session
procedure and a shortened T1 Test.
OFFLINE TIMEOUT 0:01 to 04:15 in steps of 00:01 min:s
Timeout initiated when CentryNet/Exalis
indicates lack of communication with the
machine.
JUMP PRIMING YES/NO
Enables/disables priming of a dialyser and
Cartridge Blood Set on another machine and
then treatment using this machine.
PATIENT ID 0 to 9999 in steps of 1
Code that identifies the patient within the
communication system. Each patient must
have aunique identifier within the system.
BLOOD ALARM YES/NO
Enables/disables an alarm when the Patient
Sensor detects blood for 5 minutes and the
machine is not in DIALYSIS mode.
PAUSE THERAPY YES/NO
Enables the use of Pause Therapy Mode.
pH Max 7.5 to 14.0 in steps of 0.1 pH units
High alarm threshold for chemical solution pH
monitor used in chemical process.
pH Min 1.0 to 12.5 in steps of 0.1 pH units
Low alarm threshold for chemical solution pH
monitor used in chemical process.
pH MONITOR YES/NO
Enables/disables pH monitoring during
disinfection processes.
pH VALUE set 1.00 to 12.00 pH units
Measurement of the pH value of fluid in the
hydraulic pathway.
Rev. B

Plasma Conduct set 13.00 to 17.00 mS/cm
Representation of the effective plasma
osmolarity.
Post Lying Dias 20 to 250 mmHg
Post dialysis diastolic pressure measurement in
a lying position.
Post Lying Hrat 30 to 250 pu/min
Post dialysis heart rate measurement in a lying
position.
Post Lying Syst 40 to 270 mmHg
Post dialysis systolic pressure measurement in
a lying position.
POST SITTING DIAS 20 to 250 mmHg
a sitting position.
POST SITTING H.RATE 30 to 250 pu/min
Post dialysis heart rate measurement in a
sitting position.
POST SITTING SYST 40 to 270 mmHg
a sitting position.
Post Stand Dias 20 to 250 mmHg
a standing position.
Post Stand Hrat 30 to 250 pu/min
Post dialysis heart rate measurement in a
standing position.
Post Stand Syst 40 to 270 mmHg
POST WEIGHT 8.0 to 200.0 Kg
Patient weight after dialysis.
Pre Lying Dias 20 to 250 mmHg
Pre dialysis diastolic pressure measurement in
a lying position.
Pre Lying Hrate 30 to 250 pu/min
Pre dialysis heart rate measurement in a lying
position.
Pre Lying Syst 40 to 270 mmHg
Pre dialysis systolic pressure measurement in a
lying position.
PRE SITTING DIAS 20 to 250 mmHg
a sitting position.
PRE SITTING H.RATE 30 to 250 pu/min
Pre dialysis heart rate measurement in a sitting
position.
PRE SITTING SYST 40 to 270 mmHg
sitting position.
Pre Stand Dias 20 to 250 mmHg
Pre Stand Hrate 30 to 250 pu/min
Pre dialysis heart rate measurement in a
standing position.
Pre Stand Syst 40 to 270 mmHg
standing position.
Rev. B

PRE WEIGHT 8.0 to 200.0 Kg
Patient weight before dialysis.
PRIME PUMP SPEED 50 to 150 in step of 10 ml/min
Blood pump speed value during the priming
phase.
PRIME VOLUME 100 to 4000 in steps of 100 ml
Volume of fluid infused during Dialyser Prime.
PAT CONN B FLOW 50 to 200 in step of 10 ml/min
Blood pump speed value during PAT
CONNECT phase.
BLOOD FLOW 250 to 580 in step of 10 ml/min
Blood pump speed in DIALYSIS mode.
RAMPING TIME 0:00 to 10:00 in steps of 00:30 min:s
Time period for Automatic Gradual Ramping
of the blood pump speed at initiation of
DIALYSIS. Ramping is from 50 mL/min to the
value set for INIT DIAL B FLOW over the time
defined forRAMPING TIME.
REAL TREAT TIME set 00:00 to 23:59 h:min
Real time of diffusion during DIALYSIS.
RECIRC B FLOW 50 to 580 in step of 10 ml/min
Blood pump speed initial value during the
Recirculation phase.
RECIRCULATION TIME 01:00 to 55:00 in step of 01:00 min:s
Recirculation time duration.
RECIRCULATION UF 0.100 to 3.000 in step of 0.100 Kg/h
UF rate value during the Recirculation phase.
RINSE TIME 15:00 to 50:00 min:s
Duration of ADR:RINSE process. in steps of 01:00.
If the DIACLEAR Ultrafilter is
installed: 19:00 to 50:00.
set If performing a Central

Concentrate Lines Rinse: 3 (fixed
value)
RINSING TIME 15:00 to 50:00 min:s
Duration of rinsing for chemical disinfect in steps of 01:00.
process. If the Clean Dialysate system is
installed: 19:00 to 50:00.
RINSEBACK B FLOW 50 to 200 in step of 10 ml/min
Blood pump speed initial value during the
rinseback phase.
RINSEBACK VOLUME 0 to 1000 in steps of 20 ml
Volume of saline to be given in WASHBACK
prior to alarm.
LOW CONSUMPTION 0:00 to 02:00 in steps of 00:15 h:min
Interval between the IDLE view and the
blanking of the Touch Screen (machine low
power consumption) after an ADR process
correctly completed.
SINGLE NEEDLE USE YES/NO
Enables/disables use of Single Needle
accessory.
SN P 400 to the value SET for the SN mmHg
Single Needle max commutation pressure. Pparameter increased of 40,
in steps of 5
SN P 100 to the value SET for the SN mmHg
Single Needle min commutation pressure. Pparameter decreased of 40,
in steps of 5
Rev. B

STATION ID 1 to 255 in steps of 1
Communication code that identifies the
placement of the PHOENIX within the room.
Each PHOENIX machine must have a unique
identifier.
STEP UFR 0.100 to 4.000, from 0.100 to Kg/h
UFR value related to the step selected. 0.300 in step of 0.100 and then in
(Note 3) step of 0.050
SUBNET MASK 0 to 255 in steps of 1
First part of the Subnet Mask for the machine.
SUBNET MASK 2nd 0 to 255 in steps of 1
Second part of the Subnet Mask for the
machine.
SUBNET MASK 3rd 0 to 255 in steps of 1
Third part of the Subnet Mask for the machine.
SUBNET MASK 4th 0 to 255 in steps of 1
Fourth part of the Subnet Mask for the
machine.
SYRINGE TYPE ANOTHER
3S BERTONI (30)
BD PLASTIPAK (30)
PIC LL (30)
ICO GAMMA PLUS (30)
PENTA (30)
DISPOMED (30)
TERUMO (30)
ICO GAMMA PLUS (20)
ICO MONOSTERIL (20)
BD PLASTIPAK (20)
TERUMO (20)
PIC LL (20)
PENTA (20)
MONOJECT (20)
MONOJECT (12)
BD PLASTIPAK (10)
TERUMO (10)
SYRYNGE TYPES 10 and 20 ml / 20 and 30ml
Selection of the heparin syringe volume.
TARGET Kt/V Reached YES/ NO
Enable/disable alarm for the percentage of Kt-
Kt/V TARGET reached.
TARGET Kt/V THRESH 0 to 100 in steps of 1 %
Threshold for the target Kt\Kt/V alarms.
TARGET KT 0 to 200 in steps of 1 l
Volume of body water to be purified during
DIALYSIS.
TARGET KT/V 0 to 3.00 in steps of 0.05
Dialysis Dose to be achieved during DIALYSIS.
TOT WEIGHT L 0.10 to 30.00 in step of 0.05 Kg
Amount of fluid to be removed during
DIALYSIS.
TEMPERATURE 34.0 to 39.5 in steps of 0.1 C
Temperature of the dialysate
TIME 1st P 00:00 to 23:59 in step of 00:10 h:min
Time of the first Autostart process
programmed.
TIME 2nd P 00:00 to 23:59 in step of 00:10 h:min
Time of the second Autostart process
programmed.
Rev. B

TIME 3rd P. 00:00 to 23:59 in step of 00:10 h:min
Time of the third Autostart process
programmed.
TIME DISPLAY MODE 12 h/24 h/AM/PM
Format of Time representation.
TMP set -100 to 450 mmHg
Transmembrane pressure
TMP ALARM YES/NO
Enables/disables Transmembrane pressure
alarm (Note 2)
TO VIDEO 00:10 to 01:30 in steps of 00:05 min:s
Length of time the machine remains in SET
MODE if a selection key is not pressed.
TOTAL FLUID REMOVED set 0 to 32 Kg
Total amount of fluid removed during
treatment
HEPARIN TOTAL set 5 to 30 ml
Total heparin infused.
TREATM NUMBER set 0 to number of treatments in
Number of treatments in which the DIACLEAR which the DIACLEAR Ultrafilter
Ultrafilter has been used, from the selection of has been used
the CHANGE CLEAN DIAL Action key.
DIALYSIS TIME (Note 1) 00:30 to 08:00 in step of 00:05 h:min
Dialysis treatment time duration.
CURVE TYPE PROGRESSIVE/STEP/CONSTANT
Selection of the UF curve type in PROFILING.
UF PRIMING 0.100 to 3.000 in steps of 0.100 Kg/h
Ultrafiltration rate during PRIMING.
WEIGHT LOSS/H From the value set for the WLR Kg/h
UF rate during DIALYSIS. MINIMUM parameter to 4.00; if
(Note 3) WLR MINIMUM=0 the minimum
value for WEIGHT LOSS/H is
0.100.
ULTRAF PRES 20 to 200 in steps of 10 mmHg
Pressure at the outlet of the DIACLEAR
Ultrafilter.
ULTRAFIL. USE YES/NO
Enables/disables use of the Clean Dialysate
system.
VEN P +50 to the value SET for the VEN mmHg
Venous pressure alarm threshold. PRES LIMIT parameter decreased
of +70
VINEGAR DESCAL NO/YES/ALWAYS
Enables/disables use of the Vinegar Descaling
feature.
DISTRIB VOLUME 20 to 80 in steps of 1 %
Total volume of body water for the patient
YEAR 2000 to 2099 year
Current year (calendar context)
Rev. B
Note 1
The remaining DIFFUSION TIME, calculated from the DIALYSIS TIME set, appears on the
Touch Screen.
Note 2
The first time the TMP is outside of the range set, the TMP alarm is generated. If NO has
been selected in the parameter TMP, the OVERRIDE button will reset this alarm and an
audible reminder will be triggered every 5 minutes. The TMP icon always appears in the
event of a TMP alarm and may not be reset.
Note 3
Only for the WEIGHT LOSS/H and Step UFR parameters:
once the minimum parameter value is reached, by pressing the MINUS button in SET
mode, this button is no more available;
once the maximum parameter value is reached, by pressing the PLUS button in SET
mode, this button is no more available.
Rev. B
2.2 CONFIG Views
2.2.1 MACHINE Data Configuration

The machine data configuration parameters may be changed by the operator by
selecting the MACHINE Navigation key from the Config view.
When MACHINE is pressed the Accessories view is displayed and the following
Navigation keys are available:
Communic.
Date/Times
Wait.Times
2.2.1.1 OPTIONS
When the MACHINE Navigation key from the Config view is pressed, the following
view appears, where the parameters relative to specific functions available on the
machine are displayed:
12:30
IDLE
EXTERNAL JUG USE
DIASCAN USE
SINGLE NEEDLE USE
ULTRAFIL. USE
HOT CITRIC USE
CONFIG MACHINE ACCESSORIE COMMUNIC. DATE/TIMES WAIT.TIMES CLEAN DIAL.

S
Note
The Clean Dial. Navigation key is available only if the ULTRAFIL. USE parameter is set to
YES.
Rev. B
Note
The SINGLE NEEDLE USE parameter is visible and can be set only if the arterial clamp is
installed.
Note
The ULTRAFIL. USE parameter is visible and can be set only if the DIACLEAR Ultrafilter is
used.
Note
The HOT CITRIC USE parameter is only available if the proper service configuration has
been performed in the machine calibrations environment (Refer to Section 8, in the
PHOENIX Service Manual for a detailed description of settings necessary to configure the
machine for use of the Heat Disinfection processes).
Note
Parameters can only be modified when the machine is in the IDLE mode.
Rev. B
2.2.1.2 COMMUNICATION
The Communic. menu contains the communication parameters.

When the Communic. Navigation key is pressed, the following view appears:
12:30
IDLE
CCM IDENTIF OFFLINE TIMEOUT
BAUD RATE AUTOCHART TIME
EXT SYNCHRO STATION ID
SW COMM SYSTEM IP ADDRESS 1st
NETWORK TYPE SUBNET MASK
GATEWAY
NET ROUTE1
MASK ROUTE1
CONFIG MACHINE ACCESSORI COMMUNIC. DATE/TIMES WAIT.TIMES CLEAN DIAL.

ES
Some of the above parameters are available only setting a specific value for some
other parameters: for further details see Section 7 - Communication System, in this
manual.
Note
Parameters can only be modified when the machine is in the IDLE Mode.
In order to allow a proper configuration of the communication environment, after
modifying a communication parameter:
-- Wait 5 seconds and then switch OFF the machine;
-- Wait 5 seconds and then switch ON the machine.
Note
If the parameter EXT SYNCHRO is set to a value different from 0, when the machine is
powered on, a window appears advising the operator that the PHOENIX is synchronizing
with the Exalis System. This window remains on the Touch Screen for the time set for the
EXT SYNCHRO parameter.
Rev. B
Note
In order to allow a proper configuration of the communication environment, the values
set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the
machine Calibration environment by a service technician (Refer to Section 8, in the
PHOENIX Service Manual, for a detailed description of the parameters to be set).
Note
If the SW COMM SYSTEM parameter is set toCENTRYNET USE, the STATION ID
parameter is displayed in the Config\Mach.Conf\Communic. view but the parameter
value is not modifiable in Set mode of this view. See Section 7 - Communication System,
in this manual, for a detailed description of the CentryNet relevant parameters setting.
Rev. B
2.2.1.3 DATE/TIME
The Date/Times menu contains the parameters relative to the calendar.

When the Date/Times Navigation key is pressed, the following view appears:
12:30
IDLE
YEAR TIME DISPLAY MODE
MONTH DATE DISPLAY MODE
DAY NAME
DAY
HOURS
MINUTES

ES
Note
Note
After changing the value set for the HOURS and MINUTES parameter, the machine must
be switched OFF and then ON to allow the proper updating of those values.
Rev. B
2.2.1.4 WAIT TIME
The Wait.Times menu contains the parameters relative to delays introduced to exit
from certain conditions.
When the Wait.Times Navigation key is pressed, the following view appears:
12:30
IDLE
TO VIDEO
LOW CONSUMPTION

ES
Note
Note
The blanking of the Touch Screen (low machine consumption) can be performed by both
setting the LOW CONSUMPTION parameter (blanking at the time interval set) and
pressing the SCREEN OFF Action key in Home/MACHINE view (the Touch Screen
becomes immediately blanked).
Rev. B
2.2.1.5 CLEAN DIAL
The Clean Dial. menu contains the parameters relative to the DIACLEAR Ultrafilter
alarm thresholds.
When the Clean Dial. Navigation key is pressed, the following view appears:
12:30
IDLE
ULTRAF PRES

ES
Note
Note
The Clean Dial. Navigation key is only available if the ULTRAFIL. USE parameter is set to
YES in Config/MACHINE/Accessories.
Rev. B
2.2.2 CENTER Data Configuration

The Centre data Configuration parameters may be changed by the user by selecting
the Centre Conf Navigation key from the Config view.
When Centre Config is pressed, the Automation view is displayed and the following
Functions
Treat.Conf
Alarms
2.2.2.1 AUTO
When the Centre Conf Navigation key is pressed, the following view appears:
12:30
IDLE
PRIMING HEP
DIAL AUTO PRIME
CONFIG CENTRE AUTOMATION FUNCTIONS TREAT.CONF ALARMS

CONF
Note
Pressing the Config Navigation key will return the machine to the Config selection view.
Note
Note
The DIAL AUTO PRIME parameter is only settable if the JUMP PRIMING parameter is
set to NO in Config/Centre Conf/Functions. When the JUMP PRIMING parameter is
changed from YES to NO, the DIAL AUTO PRIME parameter is automatically set to NO.
Rev. B
2.2.2.2 FUNCTION
The Functions menu contains the parameters relative to the activation of particular
functions during DIALYSIS.
When the Functions Navigation key is pressed, the following view appears:
12:30
IDLE
ACETATE DIAL USE NEW SESSION USE
BIC LIQUID DIAL USE VINEGAR DESCAL
BICART DIAL USE
AUTOEMPTYING
BEEP ON TOUCH
JUMP PRIMING
PAUSE THERAPY
CONFIG CENTRE AUTOMATIO FUNCTIONS TREAT.CON ALARMS

CONF N F
Note
Rev. B
2.2.2.3 LIMITS
The Treat.Conf menu contains the parameters relative to specific threshold settings.
When the Treat.Conf Navigation key is pressed, the following view appears:
12:30
IDLE
WLR MINIMUM
VEN PRES LIMIT
HD SAFE THRE.
TMP THRESHOLD
MAX BLOOD FLOW
RAMPING TIME
MIN ART PRESSURE

CONF N F
Note
Note
Attention should be given to setting the VEN PRES LIMIT and MIN ART PRESSURE
parameters consistently with the patient prescription (needle size, blood flow rate) to
avoid pressure alarms.
Rev. B
2.2.2.4 ALARMS
The Alarms menu contains the parameters relative to some alarm settings.
When the Alarms Navigation key is pressed, the following view appears:
12:30
IDLE
END PRE ALARM
BLOOD ALARM
HEPARIN ALARM
END HEP ALARM
TMP ALARM
END DIA ALARM
TARGET KT/V REACHED

CONF N F
Note
Rev. B
2.2.3 ADR Data Configuration

The ADR data parameters may be changed by the user by selecting the ADR
Navigation key from the Config view.
When ADR is pressed the Chemical view is displayed and the following Navigation
keys are available:
Heating
Rinsing
AutoStart
2.2.3.1 CHEMICAL
When the ADR Navigation key is pressed, the following view appears, where the
parameters related to the chemical disinfection process may be set:
12:30
IDLE
CHEM PERS 1
CHEM PERS 2
CHEM PERS 3
CHEM PERS 4
CHEM+CENTRAL
BICARB LINE
CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART
Note
The CHEM+CENTRAL BICARB LINE Action key is only available if the proper service
configuration has been performed in the service environment. (Refer to your technical
service for information on your machine configuration).
Different types of Chemical processes can be performed by pressing the CHEM PERS
1, CHEM PERS 2, CHEM PERS 3, CHEM PERS 4 or CHEM+CENTRAL BICARB LINE
Action keys. The chemical process name may be changed on this view.
Rev. B
CHEMICAL 1/2/3/4
When a chemical process has been selected pressing one of the Action keys in
Chemical view, the following view appears:
12:30
IDLE
CHEM PERS 2 RINSING TIME

DISINF TIME CHEM PERS 2
END PROCESS MODE
pH MONITOR
pH Min
pH Max
AUTO OFF
LIQUID INLET
CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE
Note
When the pH MONITOR parameter is set to YES, two further parameters are accessible:
pH Min
pH Max
WARNING
Rev. B
The chemical process name can be changed by pressing the Set button: a view similar
to the following appears:
12:30
IDLE
Chem Name
Chemical 2
DISINF TIME END PROCESS pH MONITOR

MODE
AUTO OFF LIQUID INLET RINSING TIME
Rev. B
Pressing the Chem Name parameter box will cause a new view to appear:
NEW NAME Area
1! 2" 3 4$ 5% 6& 7/ 8( 9) 0=
Q W E R T Y U I O P
Lock A S D F G H J K L
Shift Z X C V B N M coma- .:
semicol
on
\| ? ^ [ +*] @ <> -_ #
BackSpace << Space >> AltGr
Chem NameChemProc 2 BackSpace
The operator can modify the chemical process name by touching the keypad; the
new name is written in the NEW NAME Area and can be confirmed with the
CONFIRM button. Pressing UNDO will allow an exit from this view without saving
the changes made.
Rev. B
CHEM+CENTRAL BICARB LINE
When the CHEM+CENTRAL BICARB LINE Action key has been selected in the
CHEMICAL view, the following view appears:
12:30
IDLE
Chem Name RINSING TIME

DISINF TIME CENTR BICARB LINE
END PROCESS MODE
pH MONITOR
pH Min
pH Max
AUTO OFF CHEM+CENTRAL
BICARB LINE
LIQUID INLET
Note
When the pH MONITOR parameter is set to YES, two further parameters are accessible:
pH Min
pH Max
WARNING
Rev. B
The chemical process can be set by pressing the Set button: the following view
appears:
12:30
IDLE
DISINF TIME END PROCESS pH MONITOR

MODE
AUTO OFF LIQUID INLET RINSING TIME
Note
The following parameters are not accessible in Set Mode:
Chem Name: always set to Chem + B. Line;
END PROCESS MODE: always set to Rins.;
CENTR BICARB LINE: always set to YES.
Rev. B
2.2.3.2 HEAT
The Heating menu contains the parameters relative to the heating processes.
When the Heating Navigation key is pressed, the following view appears:
12:30
IDLE
HEAT
HEAT WITH CWP
HEAT CITRIC
CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART
Note
The HEAT Navigation key is only available if the proper service configuration has been
performed in the machine calibrations environment (Refer to Section 8, in the PHOENIX
Service Manual, for a detailed description of settings necessary to configure the machine
for use of the Heat disinfection option).
Rev. B
HEAT
When the HEAT Action key is pressed, the following view appears:
12:30
IDLE
DISINF TIME HEAT
AUTO OFF
COOLING
Note
When performing a standard heat disinfection, by selecting the HEAT Action key, the
COOLING parameter value is YES.
Rev. B
HEAT WITH CWP
When the HEAT WITH CWP Action key is pressed, the following view appears:
12:30
IDLE
DISINF TIME
AUTO OFF HEAT WITH CWP
COOLING
Note
When using the Centralized Heat Disinfection system, by selecting the HEAT WITH CWP
Action key, the COOLING parameter value is NO.
Rev. B
HEAT CITRIC
When the HEAT CITRIC Action key is pressed, the following view appears:
12:30
IDLE
pH MONITOR
pH Min
pH Max
HEAT CITRIC
AUTO OFF
LIQUID INLET
Rev. B
2.2.3.3 RINSE
The Rinsing menu contains the parameters relative to the rinsing process.
When the Rinsing Navigation key is pressed, the following view appears:
12:30
IDLE
RINSING TIME
AUTO OFF
CONFIG ADR CHEMICAL HEATING RINSING AUTOSTART
Rev. B
2.2.3.4 AutoStart
The AutoStart menu contains the parameters relative to the autostart process.
When the AutoStart Navigation key is pressed, the following view appears, where the
disinfection and rinsing processes may be configured to start automatically:
12:30
IDLE
1ST PROC TIME 1ST P 2ND PROC TIME 2ND P 3RD PROC TIME 3RD P.
Sunday NONE --/-- NONE --/-- NONE --/--
Monday NONE --/-- NONE --/-- NONE --/--
Tuesday NONE --/-- NONE --/-- NONE --/--
Wednesday NONE --/-- NONE --/-- NONE --/--
Thursday NONE --/-- NONE --/-- NONE --/--
Friday NONE --/-- NONE --/-- NONE --/--
Saturday NONE --/-- NONE --/-- NONE --/--
CONFIG ADR CHEMICAL HEATING RINSING AUTOSTART
Rev. B
Each process can be programmed by pressing the SET button, then selecting the
process to be configured by touching the parameter box on the Touch Screen. The
following view will appear:
12:30
IDLE
NONE RINSING HEAT
HEAT CWP CHEMIC. 1 CHEMIC. 2
CHEMIC. 3 CHEMIC. 4 H. CITRIC
Note
If FRONT is selected for the LIQUID INLET parameter in Config/ADR/Chemical or in
Config/ADR/HEAT, theCHEMIC. 1, CHEMIC. 2, CHEMIC. 3, CHEMIC. 4 and H. CITRIC
parameter are not displayed.
By pressing the CONFIRM button, the selection made is stored in the AutoStart table
and the related TIME PROCESS parameter becomes available.
To modify the value of the TIME PROCESS parameter press the SET button, select the
TIME PROCESS parameter to be configured by touching the parameter box on the
Touch Screen and change the value by using the PLUS and MINUS buttons on the
Main Control Panel. Press the CONFIRM button to accept the new value for the
parameter.
Note
If a process is programmed as NONE, the related TIME PROCESS parameter is not
modifiable and is displayed as --/-- in the AutoStart view.
Rev. B
2.2.4 Treatment Data Configuration

The Treatment data parameters may be changed by the user by selecting the
Treatments Navigation key from the Config view.
When Treatments is pressed the Std Dialysis view is displayed and the following
Heparin
BPM
2.2.4.1 STD HD
When the Treatments Navigation key is pressed, the following view appears:
12:30
IDLE
PRIME PUMP SPEED DESCALING TIME ACETATE
PAT CONN B FLOW SN P LIQUID BIC

INIT DIAL B FLOW SN P
BICART
RINSEBACK B FLOW
RECIRC B FLOW
RECIRCULATION UF
RECIRCULATION TIME
RINSEBACK VOLUME
CONFIG TREATMENT STD DIALYS HEPARIN BPM

S
The parameters relating to the different types of treatments can be programmed by

pressing the ACETATE, LIQUID BIC or BICART Action keys.
Rev. B
ACETATE
Note
The ACETATE Action key is accessible only if the parameter ACETATE is configured YES
on the Config/Centre Conf/Functions view.
When the ACETATE Action key has been pressed the following view is displayed:
12:30
IDLE
DIALYSIS TIME TOTAL BLOOD ACETATE
CONDUCTIVITY
TEMPERATURE
DIALYSATE FL.
UF PRIMING
PRIME VOLUME
END DIALYSIS
BLD SENS
CONFIG TREATMENT STD DIALYS HEPARIN BPM CLOSE

S
Note
When selecting TOTAL BLOOD for END DIALYSIS in this menu, the TOTAL BLOOD
parameter also becomes available.
Rev. B
LIQUID BIC
Note
The LIQUID BIC Action key is accessible only if the parameter LIQUID BIC is configured
YES on the Config/Centre Conf/Functions view.
When the LIQUID BIC Action key has been pressed the following view is displayed:
12:30
IDLE
DIALYSIS TIME PRIME VOLUME

CONDUCTIVITY END DIALYSIS LIQUID BIC
BICARB CONC BLD SENS
BIC 8.4% COND TOTAL BLOOD
BIC 6.6% COND
TEMPERATURE
DIALYSATE FL.
UF PRIMING

S
Note
Note
When selecting a value of 6.6% for the BICARB CONC parameter, the parameter relative
to the bicarbonate conductivity is BIC 6.6% COND.
When selecting a value of 8.4% for the BICARB CONC parameter, the parameter relative
to the conductivity value is BIC 8.4% COND.
Rev. B
BICART
Note
This Action key is accessible only if the parameter BiCart is configured YES on the Config/
Centre Conf/Functions view.
When the BICART Action key has been pressed the following view is shown:
12:30
IDLE
DIALYSIS TIME BLD SENS

CONDUCTIVITY TOTAL BLOOD
BICART COND
BICART
TEMPERATURE
DIALYSATE FL.
UF PRIMING
PRIME VOLUME
END DIALYSIS

S
Note
Rev. B
2.2.4.2 HEPARIN
The Heparin menu contains the parameters relative to all the heparinization modes.
When the Heparin Navigation key is pressed, the following view appears:
12:30
IDLE
PRE STOP TIME DIAMETER

HEPARIN RATE
INITIAL BOLUS
HEPARIN BOLUS
BOLUS INTERVAL
MANUAL BOLUS
Syringe Type
SYRYNGE TYPES

S
WARNING
If the INITIAL BOLUS is set from 0-10 ml, at the Heparin Pump start, the heparin
quantity set is injected automatically as a bolus after which the linear heparinization
starts.
Note
In order to allow a proper configuration of the heparinization mode, after modifying the
DIAMETER parameter:
Wait 5 seconds and then switch OFF the machine;
Wait 5 seconds and then switch ON the machine.
Rev. B
2.2.4.3 BPM
The BPM menu contains the parameters relative to the BPM measures.
When the BPM Navigation key is pressed, the following view appears:
12:30
IDLE
DIAST PRE MIN

DIAST PRE MAX
SYST PRE MIN
SYST PRE MAX
HEART R. MIN
HEART R. MAX
SAMPLE INTERV
BPM USE

S
Rev. B
2.2.5 Profiling Configuration

The Profiling parameters may be changed by the user by selecting the PROFILE
Navigation key from the Config view.
When PROFILE is pressed the PROFILE General view is displayed and also the
following Navigation key are available:
WLR
Cond
2.2.5.1 PROFILE General view
When the PROFILE Navigation key is pressed, the following view appears, where the
parameters for both the curves, UF and Conductivity, may be set:
12:30
IDLE
DIALYSIS TIME TOT WEIGHT L
ULTRAFILTRATION CURVE AREA CURVE TYPE
CONDUCTIVITY CURVE AREA

CON CURVE TYPE
CONFIG PROFILE WLR COND
Note
See Section 05.D - Profile, in this manual, for a detailed description of the Profile relevant
parameters setting.
Note
In case of CONSTANT curve type, the curve displayed Config/PROFILE environment is
drawn with default values set by the Manufacturer.
Rev. B
2.2.5.2 WLR
The WLR menu contains all the parameters related to the Ultrafiltration curve.
When the WLR Navigation key is pressed, the following view appears:
12:30
IDLE
ULTRAFILTRATION CURVE AREA
PARAMETER AREA
Time CURSOR AREA

UF R
CURVE TYPE: PARAMETER AREA: SET MODE:

TOT WEIGHT L CURVE TYPE
STEP CURVE TYPE TOT WEIGHT L
STEP UFR STEP UFR
PROGRESSIVE INITIAL VALUE TOT WEIGHT L
CURVE COEFF INITIAL VALUE
CURVE TYPE CURVE COEFF
CONSTANT CURVE TYPE CURVE TYPE
Rev. B
2.2.5.3 Cond
The Cond menu contains all the parameters related to the Conductivity curve.
When the Cond Navigation key is pressed, the following view appears:
12:30
IDLE
PARAMETER AREA
Time CURSOR AREA

Cond

CON CURVE TYPE CON CURVE TYPE
STEP COND STEP COND STEP
INITIAL VALUE CON CURVE TYPE

PROGRESSIVE FINAL VALUE INITIAL VALUE
CURVE COEFF FINAL VALUE
CON CURVE TYPE CURVE COEFF
CONSTANT CON CURVE TYPE CON CURVE TYPE
Rev. B
2.2.6 KT/V Configuration
The kT/V menu contains all the parameters related to the Diascan feature.
When the kT/V Navigation key is pressed, the following view appears:
Note
The kT/V Navigation key is only available if the parameter DIASCAN USE is configured
YES on the Config/MACHINE/Accessories view.
12:30
IDLE
DIASCAN TARGET KTt
CLEARANCE ALA. TARGET KT/V THRESH
CLEARANCE LEVEL TARGET KT/V
DRY WEIGHT
DISTRIB VOLUME
INTERMEASUREM
CONFIG KT/V
Note
When selecting YES, the CLEARANCE ALA. becomes available and when selecting YES
the CLEARANCE LEVEL parameter becomes available.
Rev. B
2.3 Rx Config Views

WARNING
This feature must exclusively be used under the authority of a physician, who is
solely responsible for the use of the information processed by the software.
Patient/Rx keys will individualize a particular set of prescription parameters.

The individualized prescription parameters (Patient/Rx) parameters may be changed
by the user by pressing the Rx Config Navigation key from the IDLE View.
2.3.1 Rx Config General View

When the Rx Config Navigation key is pressed, the following view is displayed:
12:30
IDLE
1st PATIENT
2nd PATIENT
3rd PATIENT
4th PATIENT
5th PATIENT
6th PATIENT
7th PATIENT
RX
CONFIG
The machine allows 7 customized dialysis sessions to be configured that can be

selected by the operator during SETUP for dialysis.
By pressing the Action keys, the individualized Treatment Data may be set and the
individual dialysis session names can be modified using the same procedure described
in the 2.2.3.1 paragraph for the personalization of the chemical process name.
When one of the Rx 1/2/3/4/5/6/7 Action keys has been pressed also the following
Navigation key are available:
Rx Data
Rx Add
PROFILE
Kt/V
Rev. B
2.3.2 Rx Data Configuration

When one of the Patient 1/2/3/4/5/6/7 Action keys has been pressed the following
view is shown (Rx Data view):
12:30
IDLE
2nd PATIENT INIT DIAL B FLOW

DIALYSIS TIME RAMPING TIME
DIALYSIS TYPE PRIME PUMP SPEED
CONDUCTIVITY RECIRCULATION TIME
BIC 8.4% COND RECIRC B FLOW
BIC 6.6% COND RECIRCULATION UF
BICART COND PAT CONN B FLOW
TEMPERATURE RINSEBACK VOLUME
DIALYSATE FL. RINSEBACK B FLOW
END DIALYSIS
TOTAL BLOOD
BLD SENS
PRIME VOLUME
UF PRIMING
RX RX DATA RX ADD PROFILE Kt/V

CONFIG
Note
Note
If NONE is selected for the HEPARIN TYPE parameter, heparinization is not automatically
activated during DIALYSIS.
If one of the three modes, LINEAR, AUTO BOLUS, MAN BOLUS, is selected, the
heparinization is automatically activated.
Rev. B
2.3.3 Rx Add Configuration

When the Rx Add Navigation key is pressed, the following view appears, where
additional treatment data parameters may be set:
12:30
IDLE
HEPARIN TYPE
PRE STOP TIME
INITIAL BOLUS
HEPARIN RATE
HEPARIN BOLUS
BOLUS INTERVAL
MANUAL BOLUS
BPM USE
DIAST PRE MIN
DIAST PRE MAX
SYST PRE MIN
SYST PRE MAX
HEART R. MIN
HEART R. MAX
SAMPLE INTERV
RX RX DATA RX ADD PROFILE Kt/V
CONFIG
Rev. B
2.3.4 Profiling Configuration
The patients personalised (Rx) Profile parameters may be changed by the user by
selecting the PROFILE Navigation key from the Rx Config view.
When PROFILE Navigation key is pressed the PROFILE General view is displayed and
also the following Navigation key are available:
UF
Cond
2.3.4.1 PROFILE General view
When the PROFILE Navigation key is pressed, the following view appears, where the
parameters for both the Profile curves, UF and Conductivity, may be set:
12:30
IDLE
DIALYSIS TIME TOT WEIGHT L
ULTRAFILTRATION CURVE AREA CURVE TYPE

CON CURVE TYPE
RX PROFILE UF COND
CONFIG
Note
See Section 05.D - Profile, in this manual, for a detailed description of the Profile relevant
parameters setting.
Note
In case of CONSTANT curve type, the curve displayed Rx Config/PROFILE environment is
drawn with default values set by the Manufacturer.
Rev. B
2.3.4.2 UF
The UF menu contains all the parameters related to the Ultrafiltration curve.
When the UF Navigation key is pressed, the following view appears:
12:30
IDLE
ULTRAFILTRATION CURVE AREA
PARAMETER AREA
Time ClkTime UF R
RX CONFIG PROFILE UF COND

STEP CURVE TYPE TOT WEIGHT L
STEP UFR STEP UFR
PROGRESSIVE INITIAL VALUE TOT WEIGHT L
CURVE COEFF INITIAL VALUE
CURVE TYPE CURVE COEFF
CONSTANT CURVE TYPE CURVE TYPE
Rev. B
2.3.4.3 Cond
The Cond menu contains all the parameters related to the Conductivity curve.
When the Cond Navigation key is pressed, the following view appears:
12:30
IDLE
PARAMETER AREA
Time ClkTime Cond

RX CONFIG PROFILE UF COND

CON CURVE TYPE CON CURVE TYPE
STEP COND STEP COND STEP
INITIAL VALUE CON CURVE TYPE

PROGRESSIVE FINAL VALUE INITIAL VALUE
CURVE COEFF FINAL VALUE
CON CURVE TYPE CURVE COEFF
CONSTANT CON CURVE TYPE CON CURVE TYPE
Rev. B
2.3.5 Kt/V Configuration
The patients personalised (Patient/Rx) Diascan parameters may be changed by the

user by selecting the Kt/V Navigation key from the Rx Config view.
When the Kt/V Navigation key is pressed, the following view appears:
12:30
IDLE
DIASCAN TARGET KT
CLEARANCE ALA. TARGET KT/V THRESH
CLEARANCE LEVEL TARGET KT/V
DRY WEIGHT
DISTRIB VOLUME
INTERMEASUREM
RX KT/V RX ADD PROFILE KT/V

CONFIG
Note
When setting DIASCAN USE to YES, the CLEARANCE ALA. becomes available and when
setting CLEARANCE ALA. to YES, the CLEARANCE LEVEL parameter becomes available.
Rev. B
Note
When a specific value is selected for some parameters, further new parameters, not listed
above, become available.
Below is a table with the various possibilities:
PARAMETER SELECTED VALUE NEW PARAMETER(S)

DIALYSIS TYPE BIC CONC BIC 8.4% CONDor
BIC 6.6% COND
BIC BICART BICART COND
END DIALYSIS TOTAL BLOOD TOTAL BLOOD
HEPARIN TYPE LINEAR PRE STOP TIME
HEPARIN RATE
INITIAL BOLUS
AUTO BOLUS PRE STOP TIME
HEPARIN BOLUS
BOLUS INTERVAL
MAN BOLUS MANUAL BOLUS
DIASCAN USE YES CLEARANCE ALA.
DRY WEIGHT
DISTRIB VOLUME
INTERMEASUREM
CLEARANCE ALA. YES CLEARANCE LEVEL
BPM USE YES or SAMPLE INTERV
AUTOMATIC SYST PRE MIN
SYST PRE MAX
DIAST PRE MIN
DIAST PRE MAX
HEART R. MIN
HEART R. MAX
JUMP PRIMING NO DIAL AUTO PRIME
Rev. B
This page is left intentionally blank
Rev. B
3 CENTRAL CONCENTRATE
SUPPLY
3. SECTION 3 - CENTRAL CONCENTRATE SUPPLY
3.1 Specifications
The Phoenix Haemodialysis System, equipped with the Central Concentrate Supply
kit, is compatible with Central Concentrate Supply Systems for BICARBONATE
DIALYSIS meeting the following requirements:
Concentrate fluid Temperature : 5 - 30 C (41-86F)

Concentrate fluid Pressure : 0 - 1 bar (0- 14.50 psi)
Bicarbonate Concentrate : 8.4%
Acid Concentrate : two different acid concentrate formulas may be used, A1 and
A2, whose composition must comply with the specifications described in the
Section 9 - Specifications of the Operators Manual.
Central Acid Concentrate Supply may be used with either the BiCart or Liquid
Bicarbonate Concentrate.
Note
The connection to Central Acid Concentrate using BICART will be allowed only if 8.4%
for Bicarbonate Concentrate has been selected in the Configuration menu.
WARNING
The user is responsible for checking compliance of Central Concentrate Systems
with the IEC 601.1.1 standard.
Rev. B
3.2 Connection to the Central Concentrate Supply System

In the following figures (fig. 3.1 and 3.2) the positions of the Connectors on the Rear
and Front Panel are illustrated with the following numerical and colour-coding:
1 - RED ACID A1 CONCENTRATE for BICARBONATE DIALYSIS

2 - RED ACID A2 CONCENTRATE for BICARBONATE DIALYSIS
3 - BLUE BICARBONATE CONCENTRATE
Fig. 3.1: Connector positions on the Rear Panel
Fig. 3.2: Connector positions on the Front Panel
Rev. B
SECTION 3 - CENTRAL CONCENTRATE SUPPLY 3-3
The connection to the Central Concentrate Supply must be done by connecting one
or more of the three Rear Panel Connectors to the facilitys Concentrate Supply
System following the numerical and colour code.
Rear Connectors marked 1,2,3 match respectively with the female Concentrate
Connectors marked 1,2,3 on the Front Panel.
WARNING
The user is responsible for the proper connection of the PHOENIX machine to the
Central Concentrate Supply System and to verify proper functioning of this
connection.
WARNING
The three internal lines from the Central Supply Ports on the Rear Panel of the
Phoenix to the three Front Concentrate Connectors marked 1, 2, 3 are subject to
the same Disinfection requirements as the Central Supply System.
The manufacturer is not responsible for the Disinfection of these lines.
Rev. B
3.3 Operating Instructions
WARNING
It is the responsibility of the user to verify that the proper concentrates are used for
the patient. This includes the choice of Acid Concentrate as well as Bicarbonate
Concentrate. The machine, while maintaining all the checks (Conductivity,
Temperature and pH) of Final Dialysate, disables the check on concentrate dilution
that is normally performed when concentrates are provided in containers. The check
on concentrate dilution is disabled when Central Concentrate Supply is used in
order to prevent the occurrence of! Concentrate Cans #40 alarm.
For further information on the concentrate solutions see Section 9 Specifications,
in this manual.
BICARBONATE DIALYSIS with A1 ACID

In this case the male Connector A must be connected to the RED (1) female
Connector, and the male Connector B must be connected to the BLUE (3) Connector
(see figure 3.3).
fig. 3.3: Connector positions in BICARBONATE DIALYSIS with A1 ACID
Rev. B
BICARBONATE DIALYSIS with A2 ACID

Connector, and the male Connector B must be connected to the BLUE (3) Connector
(see figure 3.4).
fig. 3.4: Connector positions in BICARBONATE DIALYSIS with A2 ACID
BICART DIALYSIS with A1 ACID

Connector, and the male Connector B remains in its Rinse Port (see figure 3.5).
fig. 3.5: Connector positions in BICART DIALYSIS with A1 ACID
Rev. B
BICART DIALYSIS with A2 ACID

Connector, and the male Connector B remains in its Rinse Port (see figure 3.6).
fig. 3.6: Connector positions in BICART DIALYSIS with A2 ACID
Rev. B
3.3.1 Switching from Central Concentrate Supply to the use of

External Concentrate Containers
In case of a malfunction of the Central Concentrate Supply System, it is possible to

continue the dialysis treatment using External Containers.
BICARBONATE DIALYSIS with A1 or A2 ACID
According to the External Containers that will be used, perform the following
procedures:
Bicarbonate Container: Disconnect the male Connector B from the BLUE

Connector (3) and connect it to the Wand inserted into a container of the correct
Bicarbonate Concentrate.
Acid Container: Refer to Section 05.A Special Procedures, in this manual for a
detailed description of the Acid Concentrate supply change procedure.
BICART DIALYSIS with A1 or A2 ACID
Acid Container: Refer to Section 05.A Special Procedures, in this manual for a
detailed description of the Acid Concentrate supply change procedure.
WARNING
Containers, it is the operators responsibility to verify that proper Concentrates are
being used.
WARNING
Containers, if the machine has not been correctly calibrated for the liquid
Concentrates in the External Containers, the ! Concentrate Cans #40 Alarm can
occur. After carefully verifying that the correct concentrates are being used, and
that the dialysate Conductivity is correct, the operator may clear the alarm by
performing the PA and/or PB Autocalibration Procedure (see Section 5.B - Special
Procedures for complete instructions.)
Rev. B
3.4 Central Concentrate Supply Lines Maintenance
3.4.1 General
WARNING
The three internal lines, from the Central Concentrate Supply Ports on the Rear
Panel of the Phoenix to the three Front Panel Concentrate Connectors marked 1, 2,
3 are subject to the same Disinfection requirements as the Central Concentrate
Supply System.
The manufacturer is not responsible for Disinfection of these lines.
If the machine needs to be stored, shipped, or left in Idle for a long period of time,
draining these Central Concentrate Lines, after Disinfection and Rinsing, is also
recommended.
Since these lines are practically integral to the clinics piping system, it is
recommended to have them disinfected at the same time that the overall system is
cleaned/disinfected. The frequency of cleaning these lines can be the same as the
frequency of cleaning Clinics Supply System, since the fluids are identical.
Note
It is the responsibility of the user to determine the frequency of the Cleaning/Disinfection
procedures of the Central Concentrate Lines; this frequency must be not lower than the
frequency of the Cleaning/Disinfection procedures performed for the Clinics Supply
System.
Note
The Acid Lines may not require the same frequency of Cleaning/Disinfecting as the
Bicarbonate Line since the Acid formulations typically do not support bacterial growth.
The Bicarbonate Line is where bacterial growth will occur rapidly thus frequent
Cleaning/Disinfecting is recommended. Clinical practices for cleaning other portions of
this delivery system can be used as a baseline for the Cleaning/Disinfection frequency.
WARNING
Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate
Lines, it is advisable to perform a Rinse procedure to avoid chemical reaction or
precipitation due to possible incompatibility of the chemical used with any residual
Acid or Bicarbonate Concentrate that is left in these lines.
Rev. B
3.4.2 Central Bicarbonate Line Disinfection & Rinse: automatic

processes
The Central Bicarbonate Line disinfection is a chemical process that allows to disinfect
both the hydraulic flowpath of the machine and the central bicarbonate line from the
rear panel of the machine to the male dialysate connector fitting to the Central
Concentrate Supply System.
To carry out the Central Bicarbonate Line disinfection and the following rinse the
following conditions have to be satisfied:
The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix
(See Figure 3.1) to the Central Concentrate Supply system has to be adapted so
that the end side of this line (connected to the Central Concentrate Supply port)
is a Phoenix Bicarbonate Male Connector;
(See Figure 3.1) to the Central Concentrate Supply system has to be a PVC line,
maximum 3 metres (118.11 in) in length and with an internal diameter of 3 mm
(0.118 in).
The proper service configuration has been performed in the service environment.
(Refer to your technical service for information on your machine configuration).
Only Sodium hypochlorite solution (active chlorine from 50,000 to 60,000
ppm)/Bleach has to be used.
WARNING
The efficiency of the Central Bicarbonate Line disinfection process has been tested
and can be guaranteed only if the following conditions are satisfied:
The Central Bicarbonate Line connecting the Rear Connector (3) of the
Phoenix (See Figure 3.1) to the Central Concentrate Supply system is a PVC
line, maximum 3 metres (118.11 in) in length and with an internal diameter of
3 mm (0.118 in),
ppm)/Bleach is used.
3.4.2.1 Disinfection Procedure
1. Disconnect the Bicarbonate Connector from the Bicarbonate Port (B) on the
Front Panel and connect it to the BLUE (3) port on the Front Panel. (See Figure
3.7).
2. Verify that the Acid Connector is connected to the Acid Port (A) on the Front
Panel.
3. Disconnect the Central Bicarbonate Line on the Rear of the machine from the
Central Concentrate Supply system and connect it to the Bicarbonate Port (B) on
the Front Panel of the machine. (See Figure 3.7).
WARNING
Before starting a Central Bicarbonate Line disinfection process, it is the operators
placed to ensure the disinfection process is properly performed.
Rev. B
fig. 3.7: Connector positions in Central Bicarbonate Line Disinfection
4. Place the disinfectant connectors in the correct position. Depending upon the
selection of the parameters EXTERNAL JUG USE and LIQUID INLET:
EXTERNAL JUG USE:NO

LIQUID INLET:FRONT
Disconnect the Yellow Connector from its Rinse Port on the lower front panel
of the machine and connect it to the Yellow Wand. Immerse the Yellow
Wand into the disinfectant container.
EXTERNAL JUG USE:YES

LIQUID INLET:FRONT
Perform the previous procedure.
EXTERNAL JUG USE:YES

LIQUID INLET:REAR 1/REAR 2
Ensure that the disinfectant connector (present on the rear of the machine) is
correctly inserted in the disinfectant container located on the rear of the
machine. Also verify that there is enough liquid to perform a disinfection
procedure.
Rev. B
5. Perform the Bicarbonate Line Disinfection process:

Select the ADR Selection key on the IDLE view and then press the CHEM
PROCESS Selection key.
Press the CHEM + CENTR BICARB LINE Action key. The machine will start
uptaking of disinfectant to fill an internal tank (approximately 180 ml). The
following view is displayed:
12:30
ADR PROGRESS
DISINF TIME RINSING TIME

min:s min:s
END PROCESS AUTO OFF

MODE
pH VALUE LIQUID INLET
BPM REPORT MACHINE

CLOSE
Note
If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front Panel (see
Figure 3.7), the alarm message Centr. Bicarb Connector Position (code #272) is
displayed while in the Operator Messages Area the following message will appear:
Central bicarb wall connector must be in
blue port and blue connector in CCK blue port
If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front
Panel of the machine (see Figure 3.7), the alarm message B Connector Position(code
#18) is displayed.
Note
If any problems occur while the disinfectant is being taken up into the internal tank, the
machine will automatically empty and refill the tank.
An Operator Message will appear:
Emptying Disinfectant Tank And
Repeat Filling Disinfectant Tank
Note
If LIQUID INLET is set to FRONT at the completion of disinfectant uptake, the following
alarm message is displayed:
Disinf Connector Position
with an audible alarm (#47).
To clear this alarm and restart the disinfection procedure reinsert the Yellow Connector
into its Rinse Port.
Rev. B
6. Central Bicarbonate Line disinfection stops:

When the time value set for the DISINF TIME parameter is elapsed.
When the machine goes into an alarm condition during the process and the
operator takes no action. The machine will automatically turn OFF after 30
minutes following completion of the DISINF TIME. At the next switch on
Central Bicarbonate Line disinfection must be performed again to allow the
selection of the DIALYSIS process.
When the CLOSE Action key is selected 30 seconds after the disinfection
process has been started and before the DISINF TIME has elapsed. In this
case the process is not considered complete and the Central Bicarbonate
Line disinfection must be performed again to allow the selection of the
DIALYSIS process.
When the CLOSE Action key is selected within 30 seconds after the
disinfection process has been started. In this case the process selection is
cancelled and all the keys that were available before starting the Disinfection
process will remain available.
7. When the Central Bicarbonate Line disinfection has been correctly completed, an
ADR:RINSE process will automatically start. (See 3.4.2.2 ADR: RINSE , in this
section)
Note
The Central Bicarbonate Line disinfection can not be programmed by the AutoStart
feature.
Rev. B
List of Parameters and their meanings
DISINF TIME: this parameter can be set to a value between 15 min and 30 minutes.
The default value for this parameter is the lowest value necessary to ensure
disinfection of the machine when an approved disinfectant is used.
pH Min and pH Max: these parameters appear only if the parameter pH MONITOR
on the Config\ADR\CHEM+CENTRAL.BICARB LINE view is set to YES. During the
process an alarm is triggered when the pH value is outside the range selected by the
operator for the two parameters.
RINSING TIME: this parameter can be set to a value between 15 min and 50 minutes.
Once the Central Bicarbonate Line disinfection has been correctly completed, a
rinsing phase is automatically performed.
AUTO OFF: if NO is selected, the machine returns to the IDLE view after performing
the RINSE process, if YES is selected, the machine turns OFF automatically.
END PROCESS MODE: this parameter is always set to Rins. and can not be modified;
at the end of the chemical disinfection process, the machine performs a RINSE
process for the time set for the parameter RINSING TIME parameter.
LIQUID INLET: This parameter specifies the line through which the uptake of
disinfectant is performed. This parameter can be set to FRONT, REAR 1 or REAR 2,
only if the EXTERNAL JUG USE parameter is set to YES in the Config/MACHINE view.
When set to YES, the EXTERNAL JUG USE parameter allows the machine to uptake
disinfectant from the chemical connector (yellow) on the FRONT of the machine or
from REAR 1 or REAR 2 at the back of the machine. When set to NO the internal
disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the
front of the machine.
CENTR BICARB LINE: this parameter is always set to YES and can not be modified. It
indicates that a disinfection process will be performed disinfecting both the hydraulic
flowpath of the machine and the central bicarbonate line from the rear panel of the
machine to the male dialysate connector fitting to the Central Concentrate Supply
System.
Rev. B
3.4.2.2 ADR: RINSE following the Central Bicarbonate Line

disinfection
The RINSING process described below described allows to rinse both the hydraulic
flowpath of the machine and the central bicarbonate line from the rear panel of the
machine to the male dialysate connector fitting to the Central Concentrate Supply
System.
1. During the RINSING process, connectors must remain in the same configuration
of the Central Bicarbonate Line disinfection.
2. The RINSING process starts automatically once the Central Bicarbonate Line
disinfection is completed. During the RINSING process the following view is
displayed:
12:30
ADR PROGRESS
RINSING TIME AUTO OFF

min:s
BPM REPORT MACHINE

CLOSE
Note
If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front Panel (see
Figure 3.7), the alarm message Centr. Bicarb Connector Position (code #272) is
displayed while in the Operator Messages Area the following message will appear:
Central bicarb wall connector must be in

blue port and blue connector in CCK blue port
If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front
Panel of the machine (see Figure 3.7), the alarm message B Connector Position (code
#18) is displayed.
Rev. B
3. During RINSING, the machine performs the UF Vessel Level Detectors Test. If the
UF Vessel Level Detector Test fails, the following operator message will appear:
Emptying UF Vessel forced
The process time will be increased.
4. Central Bicarbonate Line Rinse process stops:

When the time value set for the RINSING TIME parameter is elapsed.
minutes following completion of the RINSING TIME. At the next switch on,
Central Bicarbonate Line Rinse process must be performed again to allow
the selection of the DIALYSIS process.
When the CLOSE Action key is selected before the RINSING TIME has
elapsed. In this case the process is not considered complete and the Central
Bicarbonate Line Rinse process (maintaining the same connectors
configuration of the Central Bicarbonate Line disinfection) must be
performed again to allow the selection of the DIALYSIS process.
5. When the Central Bicarbonate Line Rinse process has been correctly completed,
the following Help message will appear on the Touch Screen in the Parameter
Area:
To allow SETUP remove connector from
Central bicarb port and reinsert if needed
6. To make available the SETUP Action key and delete the above Help message:
Disconnect the Bicarbonate Connector from the BLUE (3) port on the Front
Panel. and connect it to the Bicarbonate Port (B) on the Front Panel (See
Figure 3.7).
Disconnect the Central Bicarbonate Line from the Bicarbonate Port (B) on
the Front Panel of the machine and connect it to the Central Concentrate
Supply system (See Figure 3.7).
Note
The Central Bicarbonate Line Rinse process can not be programmed by the AutoStart
feature.
Rev. B
3.4.3 Acid and Bicarbonate Lines Rinse: automatic process
An automatic process can be performed to rinse both the Central Bicarbonate Line
and the Central Acid Lines (A1 and/or A2).
To carry out the Central Concentrate Lines Rinse process the following conditions
have to be satisfied:
The proper service configuration has to be performed in the machine calibrations

environment (Refer to Section 8, in the Phoenix Service Manual).
If Central Bicarbonate Line Rinse has to be performed:

mates to the Female Bicarbonate Connector (B) on the Front of the machine
(See Figure 3.2);
(See Figure 3.1) to the Central Concentrate Supply system has to be maximum 3
metres (118.11 in) in length and with a diameter of 3 mm (0.118 in).
If Central Acid (A1) Line Rinse has to be performed:

The Central Acid (A1) Line connecting the Rear Connector (1) of the Phoenix
mates to the Female Acid Connector (A) on the Front of the machine (See Figure
3.2);
If Central Acid (A2) Line Rinse has to be performed:

mates to the Female Acid Connector (A) on the Front of the machine (See Figure
3.2);
Rev. B
3.4.3.1 Rinse Procedure
1. Depending on the Central Bicarbonate Lines to be rinsed:
Central Bicarbonate Line: Disconnect the Bicarbonate Connector from the

Bicarbonate Port (B) on the Front Panel and connect it to the BLUE (3) port
on the Front Panel. Disconnect the Central Bicarbonate Line on the Rear of
the machine from the Central Concentrate Supply system and connect it to
the Bicarbonate Port (B) on the Front Panel of the machine. Note: If only the
Central Bicarbonate Line is rinsed, verify the Acid Connector is connected to
the Acid Port (A) on the Front Panel. (See Figure 3.8 (A)).
Central Acid Line (A1): Disconnect the Acid Connector from the Acid Port
(A) on the Front Panel and connect it to the RED (1) port on the Front Panel.
Disconnect the Central Acid Line (A1) on the Rear of the machine from the
Central Concentrate Supply system and connect it to the Acid Port (A) on the
Front Panel of the machine. Note: If only the Central Acid Line (A1) is rinsed
verify the Bicarbonate Connector is connected to the Bicarbonate Port (B) on
the Front Panel. (See Figure 3.8 (B)).
Central Acid Line (A2): Disconnect the Acid Connector from the Acid Port
(A) on the Front Panel and connect it to the RED (2) port on the Front Panel.
Disconnect the Central Acid Line (A2) on the Rear of the machine from the
Central Concentrate Supply system and connect it to the Acid Port (A) on the
Front Panel of the machine. Note: If only the Central Acid Line (A2) is rinsed
verify the Bicarbonate Connector is connected to the Bicarbonate Port (B) on
the Front Panel. (See Figure 3.8 (C)).
Central Acid Line (A1) and Central Acid Line (A2): Disconnect the Acid
Connector from the Acid Port (A) on the Front Panel and connect it to the
RED (1) port on the Front Panel. Disconnect the Central Acid Line (A1) on
the Rear of the machine from the Central Concentrate Supply system and
connect it to the RED (2) port on the Front Panel. Disconnect the Central
Acid Line (A2) on the Rear of the machine from the Central Concentrate
Supply system and connect it to the Acid Port (A) on the Front Panel of the
machine. Note: If only the Central Acid Line (A1) and (A2) are rinsed verify
the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the
Front Panel. (See Figure 3.8 (D)).
Central Acid Line (A1) and Central Bicarbonate Line: place the connectors
as described in the above steps Central Bicarbonate Line and in Central
Acid Line (A1). (See Figure 3.8 (E)).
Central Acid Line (A2) and Central Bicarbonate Line: place the connectors
as described in the above steps Central Bicarbonate Line and in Central
Acid Line (A2). (See Figure 3.8 (F)).
Central Acid Line (A1), Central Acid Line (A2) and Central Bicarbonate
Line: place the connectors as described in the above steps Central
Bicarbonate Line and in Central Acid Line (A1) and Central Acid Line (A2).
(See Figure 3.8 (G)).
Rev. B
(A) Central Bicarbonate Line (B) Central Acid Line (A1)
(C) Central Acid Line (A2) (D) Central Acid Line (A1) and Central Acid Line (A2)
fig. 3.8: Connector positions in Central Concentrate Lines Rinse
Rev. B
(E) Central Bicarbonate Line + Central Acid Line (A1) (F) Central Bicarbonate Line + Central Acid Line (A2)
(G) Central Bicarbonate Line + Central Acid Line (A1)

+ Central Acid Line (A2)
fig. 3.8: Connector positions in Central Concentrate Lines Rinse
Rev. B
WARNING
Before starting a Central Concentrate Rinse process, it is the operators
placed to ensure all the lines involved in the Central Concentrate Rinse process are
properly rinsed.
2. Select the ADR Selection key on the IDLE view and then press the CCK LINES
RINSE Action key. The following superimposed window will appear:
CONFIRMATION LAST ACTION MADE
ENTER To Confirm
By pressing the CONFIRM button, the machine will start the Central Concentrate
Rinse process.
Note
The CCK LINES RINSE Action key is not available if the ADR processes (Chemical
Disinfection or Heat Citric Disinfection) previously performed were not been correctly
completed.
3. During all the time the process is in progress the following message will appear in
the Operator Messages Area:
To rinse one or more central concentrate lines,
ensure they are disconnected from the wall and
inserted in rinse ports and the corresponding
connectors are in central concentrate ports.
Note
The RINSING TIME parameter is automatically set to 3 minutes, this parameter value
cannot be modified.
4. Central Concentrate Supply Rinse process stops:
When the RINSING TIME is elapsed.

minutes following completion of the RINSING TIME. At the next switch on, all
the ADR processes allowed before the CCK LINES RINSE Action key selection
are still available except a standard RINSING process.
When the CLOSE Action key is selected before the RINSING TIME has
elapsed. In this case the process is not considered complete but all the ADR
processes allowed before the CCK LINES RINSE Action key selection are still
available except a standard RINSING process.
Rev. B
5. When the Central Concentrate Supply Rinse process has been correctly
completed, the following Help message will appear on the Touch Screen in the
Parameter Area:
SETUP not Allowed. A Disinf. Process
Must be performed to allow SETUP
6. Restore the previous connectors configuration.

7. To make available the SETUP Action key and delete the above Help message
perform a Disinfection process.
Note
The Central Concentrate Lines Rinse process can not be programmed by the AutoStart
feature.
Rev. B
3.4.4 Acid and Bicarbonate Lines Maintenance (Disinfection, Rinse

and Drain): manual procedure
Note
The Disinfection, Rinse, Verification and Draining procedures, described below, can be
applied to any of the 3 Central Concentrate Lines. The Lines may be disinfected
simultaneously or independently. It is the responsibility of the user to determine the
frequency of the Cleaning/Disinfection procedures of these Central Concentrate Lines; this
frequency must be not lower than the frequency of the Cleaning/Disinfection procedures
performed for the Clinics Supply System.
3.4.4.1 Adaptor Setup
Assemble an adaptor that mates to the female Central Concentrate fitting(s) on the
Front of the machine:
If the Bicarbonate Line is to be disinfected, use a male Bicarbonate Male
Connector as one end of the adaptor.
If the Acid line(s) is to be disinfected, one end of the adaptor would be an Acid
Male Connector.
Note
The Dialysate Sampling Connector (Universal) can also be used.
This adaptor should be built such that when pressure is applied to the Central
Concentrate System, flow should occur through this connector.
It is recommended to attach a silicone tube to the outlet side of this adaptor. The
length of the tube would depend on whether one wanted to divert the
Disinfectant/Rinse flow into a container.
The following components can be used to assemble the adaptor:

Dialysate Sampling Connector (Universal) code 6961031.
Acid Male Connector code 6954291.
Bicarbonate Male Connector code 6948996.
1/8 inch silastic tubing, 95 inch roll.
Two additional components may be required:

A Restrictor: may be needed to reduce flow (depending on the pressure and flow
conditions within the facilitys Central Concentrate System) while
Disinfection/Rinsing is taking place.
A Check Valve: may be inserted into the line to prevent any back flow.
Note
For further information on the availability of this adaptor, or the components required to
assemble it, contact your Local Representative.
Rev. B
3.4.4.2 Disinfection Procedure
1. Turn the machine OFF.

2. Connect the adaptor, described above, to the female Central Delivery Port on the
Front Panel of the machine that is to be disinfected.
3. Put the outlet tubing from the adaptor into a container.
4. Disinfect the concentrate lines in the machine and the Central Concentrate
Delivery System. Verify the efficacy of the disinfection procedure. Chemical
presence can be verified at the outlet of the adaptor.
Note
The pressure used within the Central Concentrate System for the Cleaning and
Disinfection of the 3 lines must be adequate to push water through this system, for
cleaning and disinfection of the lines within the machine. This will depend somewhat
upon Drain or Container position. However, the pressure should be limited to prevent
disconnection due to excessive pressure. A pressure range of 250-500 mmHg is
recommended as an initial estimate for an acceptable pressure.
3.4.4.3 Rinse Procedure
1. Leave the adaptor in the Central Concentrate Port.

2. Rinse the Central Concentrate Supply System with water to remove chemicals
introduced during the Cleaning/Disinfection process.
3. Route the Rinse water directly to a container.
3.4.4.4 Rinse Verification
1. Verify the efficacy of Rinsing. Rinsing efficacy for the Central Concentrate Lines
within the machine can be verified at the outlet of the adaptor, mentioned above.
2. If draining is not to be done, the adaptor may be removed after this Rinse
verification step.
Rev. B
3.4.4.5 Draining of Central Concentrate Lines
Note
Draining of Central Concentrate Lines is recommended for machine storage, shipping, or
long Idle period.
1. Make certain that the Disinfection, Rinse, and Rinse Verification steps have
previously been performed on the Central Concentrate Line(s).
2. Remove Central Concentrate Line(s) at the back of the machine from the Central
Concentrate Supply. This line(s) should be open, and exposed to atmosphere.
3. Use the adaptor and attach a syringe to the outlet tubing (the side opposite of the
male Concentrate Connector). Attach this adaptor the Central Concentrate Line
where fluid is to be drained. Use the syringe to remove all fluid from the Central
Concentrate Line.
4. Remove the adaptor.
Alternative Drain Procedure:

1. Make certain that the Disinfection, Rinse, and Rinse Verification steps have
previously been performed on the Central Concentrate Line(s).
2. Remove the Central Concentrate Line(s) from the rear of the machine.
3. Turn the machine ON. Enter SETUP.
4. Insert the male Concentrate Connector on the front of the machine into the Central
Delivery Port that is to be drained.
5. Let machine run until the lines are empty.
Rev. B
4 INSTALLATION
4. SECTION 4 - INSTALLATION
4.1 Unpacking instructions

Check that the shipping container is not damaged.
If the shipping container is damaged, notify the transporter before opening.
Carefully take the machine out of its packaging.
Note
The PHOENIX shipping carton, foam packing and other packaging materials should be
disposed of according to local regulations.
4.2 Shipping Carton Contents
The machine packaging contains the following components:
PHOENIX Haemodialysis System

PHOENIX Operators Manual
Installation Checklist
Water inlet and drain hose
Hose clamps
Sampling connector
Dialysate connectors and tubing
IV pole (maximum load: 6 Kg or 13.2 lb)
Note
Adjustment of IV pole height must be done without bags on the hooks.
Concentrate/disinfectant wands
Chemical container shelf (maximum load: 16 Kg or 35.3 lb)
pH probe assembly
Blood pump crank
BPM CUFF
Single Needle holder (only with machines that have been configured with an
Arterial Line Clamp).
WARNING
Do not stand on Chemical container shelf.
Rev. B
4.3 Installation
Power supply
Connect the power cord to a grounded, hospital-grade main power outlet (suitable
for continuous operation) according to the voltage and current rating listed on the
identification plate at the rear of the PHOENIX machine. Electrical power
requirements can be found in Section 9 Specifications, of the PHOENIX Operators
Manual.
WARNING
Check the continuity and the reliability of the ground connection.
WARNING
Verify the quality of the protective earth ground at the time of installation.
Water inlet connection

Connect the 8x14 meshed PVC hose to the water inlet port on the rear of the
PHOENIX (see fig.4.1). The Water Inlet Port symbol, located on the label on the rear
panel, shows where the inlet water hose is to be connected.
Attach the water inlet hose to the treated water for haemodialysis, using a stainless
steel hose clamp.
Requirements for water for haemodialysis can be found in Section 9 Specifications,
of the PHOENIX Operators Manual.
Note
Check that the pressure is between 1 Kg/cm2 and 6 Kg/cm2(14.6 to 87.6 psig).
Drain hose connection

Connect the 8x14 PVC hose, contained in the shipping carton, onto the drain port on
the rear of the PHOENIX machine (see fig.4.1). The Drain Port symbols, located on
the label on the rear panel, show where the drain hose is to be connected.
Connect the drain hose to a drainage system that satisfies the following requirements:
Maximum height above floor level: 1 m (39 inches).

Maximum Dialysate flow: 1.1 l/min.
Resistant to treated water and chemicals used for disinfection.
Resistant to high temperature (~100C) water, drained during the heat disinfection
process.
Rev. B
SECTION 4 - INSTALLATION 4-3
Make connections as described in the international standards or in the local plumbing

and electrical regulations, in respect of separation of devices (drain line and drain
itself), back syphonage and the air clearance between the drain connector of the
machine and the drain itself.
Drain Port
Water inlet Port
Figure 4.1
Dialyser connection
Insert the TO and FROM dialysate lines onto their ports on the left side of the
PHOENIX machine.
These ports are coloured blue and red appropriately.

Insert the dialyser connectors onto the other end of the lines:
Blue connector: TO dialyser line
Red connector: FROM dialyser line
Insert the dialysate connectors onto their colour coded bypass ports.
Rev. B
4.4 First service
WARNING
This operation must be performed by authorized personnel. If Service is performed
by unauthorized personnel, the manufacturer cannot accept any responsibility for
any damage which may occur, and such damage is not covered by the warranty.
General
Open the machine panels and visually inspect the hydraulics and electronics for
any loose connections or damage from shipment.
Mount a pump insert on each of the four peristaltic pumps as follows:

Open the mechanical lock on each peristaltic pump.
Insert the tube connectors in the seats on the collar.
Before mounting, twist the collar and tube backwards. This initially stretches the
tube.
Assemble the collar and tube onto each pump. Verify that the collar and tube are
mounted correctly onto each pump. Verify that the tubing connector is snug in its
mount.
Mount the pH Probe as follows:

Remove the plastic cover that protects the pH probe holder
Remove the cap from the hydraulic circuit where the probe will be mounted.
Remove the cover from the probe.
Mount the pH probe using the pH Holder Nut, supplied in the pH probe box.
Attach the pH probe to the support using the plastic tie wrap contained in the pH
probe box.
Remount the protective plastic cover on the pH probe holder.
Route the wires from the pH probe so that they are secure in their path to the pH
circuit board. Connect the probes BNC connector to the pH circuit board.
Note
Carefully read the instruction sheet in the pH probe box.
Check that all tubing and connection are correct and secure.
Rev. B
SECTION 4 - INSTALLATION 4-5
Functional Check
WARNING
Do not use this machine near flammable gas or flammable anaesthetic mixtures
with air, with oxygen or with nitrous oxide.
Prior to the first patient use, the PHOENIX must be tested by a trained Service
technician.
Perform the complete installation procedure found in the PHOENIX Service

Manual.
Perform the autocalibration procedure for the concentrate pumps using the
concentrate formulas used in the dialysis facility. This is done so that the speed of
the pumps for the facilitys concentrates will be stored in the concentrate
exchange safety system.
The machine is calibrated by the manufacturer to guarantee the operating range

described in the Specification Section for the specified concentrates.
Machine disinfection:
Perform the Water Inlet Line Disinfection procedure.
Perform a chemical disinfection procedure with the disinfectants that are in use in
the dialysis facility.
Perform a heat citric disinfection procedure with the disinfectants that are in use
in the dialysis facility.
The purpose of these procedures is to calibrate the insert in the PS pump,
therefore the efficacy of these first disinfections is not guaranteed.
Notify the operator that the machine must be disinfected again prior to use.
Notify the operator that a post-dialyser dialysate sample should be cultured for
machine bioburden levels, as per AAMI and CDC guidelines. Follow your facility
protocol for collecting and culturing the sample.
Rev. B
Rev. B
5 DIALYSIS OPERATION
5. SECTION 5 - DIALYSIS OPERATION
5.1 Starting
5.1.1 Residual Disinfectant Concentration Test

The Residual Disinfectant Concentration Test may be performed in SETUP, prior to
using the machine for a patient treatment.
Follow the Dialysate Sampling procedure, found in Section 5.A Special Procedures
of this manual, with the machine in the SETUP Mode, prior to connecting the dialyser
for priming.
Note
It is not necessary to discard liquid before obtaining a sample for the Residual Disinfectant
Concentration Test.
5.1.2 Checking dialysis parameters configuration

Parameters related to processes configured in the machine are displayed on the
Config view. The Config view is only accessible from the IDLE view, prior to pressing
the SETUP Action Key.
Rev. B
5.2 Extracorporeal Circuit preparation

WARNING
The Manufacturer has not validated the use of blood lines other than those
specified in this manual. The Manufacturer does not assume responsibility or
liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It
is the responsibility of the user to validate that other blood lines provide safe and
effective performance.
WARNING
It is the responsibility of the physician to ensure that the appropriate
Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being
treated.
Before installing a Gambro/Hospal Cartridge Blood Set, carefully read the
Cartridge Blood Set Instructions for Use.
5.2.1 Install dialyser

Place the dialyser into the Dialyser Holder (left side of machine).
a. Lift the holder arm and position the dialyser between the arm and the grippers
attached to the machine.
b. Close the holder arm. (The dialyser is held in position between the holder arm and
the grippers.)
WARNING
Reverse Ultrafiltration of fluid from the dialysate compartment into the blood
compartment may occur when High Flux dialysers are used. Because of their high
ultrafiltration coefficients, high flux dialysers will quickly transfer fluid across the
membrane in response to pressure differences between the dialysate compartment
and the blood compartment.
5.2.2 Load the Cartridge Blood Set

To load the Cartridge Blood Set proceed as follows (see Fig 5.1):
a. Open the Blood Pump Cover by pressing the cover latch then open the Air Bubble
Detector/Patient Sensor cover.
b. Place the pump segment of the Cartridge Blood Set around the blood pump rotor.
Note
The blood pump rotor is in a horizontal position.
This is the default position after switching ON the machine.
The blood pump cover can be closed when the blood pump rotor is in the default
position.
c. Insert the tab of the Cartridge Blood Set into the cartridge clip (left side of cartridge
holder). Press the Cartridge against the machine. The pressure pods should seat
evenly on the pressure transducers.
d. Close the Blood Pump Cover. (Cover makes a clicking sound as it latches).
Rev. B
SECTION 5 - DIALYSIS OPERATION 5-3
e. Route the venous line through the Air Bubble Detector/Patient Sensor and through
the Venous Line Clamp.
f. Close the Air Bubble Detector/Patient Sensor cover (cover makes a clicking sound
as it latches).
g. Before attaching the venous and arterial dialyser lines of the Cartridge Blood set to
the dialyser blood ports, rotate the dialyser lines counter-clockwise (about 1 full
turn); then connect the dialyser lines to the dialyser blood ports.
h. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes
from interfering with Phoenix machine or its parts. Ensure that lines are untangled.
i. Route the Cartridge access lines into the 4 Position Line Clamp above the blood
pump. Route the lines from right to left as follows:
Heparin line green clamp
Arterial access line red clamp (right)
Cartridge saline line (with priming connector) red clamp (left)
Venous access line blue clamp
The Arterial access line, Cartridge saline line and Venous access line make a
clicking sound when they are firmly inserted in the 4 Position Line Clamp.
If performing a Single Needle dialysis (option):
1. Route the arterial line through the arterial line clamp.

2. Use a Cartridge Blood Set equipped with expansion chambers.
3. Mount the Single Needle holder (see Section 5.A - Special Procedures, in this
manual, for the Installation of the Single Needle holder procedure).
4. Insert the pre-dialyser and post-dialyser expansion chambers in their respective
holders (with the level adjustment lines pointing upwards).
The Single Needle holder is provided of two clip connections to secure the pre
and post-dialyser expansion chambers. To mount the pre-dialyser expansion
chamber press with the thumb the bottom side to the higher single needle holder
arm while levering to the Single Needle holder with the rest of the hand. To
mount the post-dialyser expansion chamber press with the thumb the top side to
the lower single needle holder arm while levering to the Single Needle holder
with the rest of the hand. Both pre and post-expansion chambers must fit properly
to the single needle holder arms.
5. Be sure that the clamp above the pre-dialyser expansion chamber and the clamp
above the post-dialyser expansion chamber are closed.
6. Before attaching the arterial dialyser line (from the bottom of the pre- dialyser
pumping chamber) to the arterial dialyser port (on the top of the dialyser), rotate
the arterial dialyser line counter-clockwise (about 1 full turn); then connect the
arterial dialyser line to the arterial dialyser port.
7. Before attaching the venous dialyser line (from the bottom of the post- dialyser
pumping chamber) to the venous dialyser port (on the bottom of the dialyser),
rotate the venous dialyser line counter-clockwise (about 1 full turn); then connect
the venous dialyser line to the venous dialyser port.
8. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes
from interfering with Phoenix machine or its parts. Ensure that lines are untangled.
9. Route the venous line into the Air Bubble Detector and through the Venous Line
Clamp.
10. Close the Air Bubble Detector cover (cover makes a clicking sound as it latches).
11. Route the Cartridge access lines into the 4 Position Line Clamp above the blood
pump.
Route the lines from right to left as follows
Heparin line green clamp
Arterial access line red clamp (right)
Rev. B
Cartridge saline line red clamp (left)

Venous access line blue clamp
The Arterial access line, Cartridge saline line and Venous access line make a
clicking sound when they are firmly inserted in the 4 Position Line Clamp.
Note
Clamp all lines except the heparin line. Leave the heparin line unclamped so it can be
primed with heparin from the heparin syringe.
WARNING
Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if
Single Needle is available on the machine).
WARNING
When the cover of the blood pump is open, verify that the pump is off.
WARNING
Improper connections of the extracorporeal circuit may cause potential patient
safety hazards, that might not be detected by the machine: for instance, hemolysis
caused by kinks, twists, loops, sharp bends, clamps or other restrictions on the
blood line, blood loss to the environment/air into the blood circuit due to leakage
in the extracorporeal circuit.
WARNING
Before inserting the venous line in the Air Bubble Detector clean and dry it. Fluid
and gel substances applied on the Air Bubble Detector may reduced the Air Bubble
Detector sensitivity causing patient injury or death. Refer to "6.8.1 External surface
cleaning" paragraph, in the Section 06 - Clean/Disinfect, for the description of how
to clean the Air Bubble Detector.
Rev. B
Fig. 5.1 Cartridge Blood Set Loading
Rev. B
5.2.3 Fill and install heparin syringe

a. Fill a syringe with the desired amount of heparin solution and push the syringe
plunger to expel any air.
b. Verify that the heparin line of the Cartridge Blood Set is installed in the green
clamp of the 4 Position Line Clamp.
c. Attach the heparin line to the heparin syringe.
d. With the (ARROW LEFT) and (ARROW RIGHT) buttons on the Heparin
Control Panel, move the heparin syringe plunger clamp to fit the syringe. Position
the wings of the syringe against the syringe holder so that they will fit between the
plastic clips. Lock it in place with the clamp and close the syringe holder with the
clip (to keep the syringe in place).
e. Verify that the heparin line on the Cartridge Blood Set is unclamped.
Rev. B
5.2.4 Connect saline

a. Clamp the saline administration line that is connected to the venous line. Remove
the cover from the saline administration line and insert the spike into a 1000 ml
bag of saline.
b. Hang a saline sterile bag on the IV pole.
Rev. B
5.3 SETUP selection
Overview
The dialysate preparation process is started by selecting the SETUP Action key from
the IDLE view. The DIAL. CHOICE view appears which displays options for the type
of dialysate to be used (ACETATE, BICARB CONC, BICART).
Note
If, after the selection of the SETUP Action key, the Cartridge Blood Set has not been
installed, the following message will be displayed in the Operator Message Area:
Warning: the cassette MUST be installed

before starting the preparation.
Only after the Cartridge Blood Set installation, the Operator Message will disappear and
the ACETATE, BICARB CONC and BICART Action key will become available.
SELECT DIALYSATE VIEW:
12:30 DIAL. CHOICE
ACETATE
BICARB CONC
BICART
NEW SESSION
BPM REPORT KT/V PROFILE HEPARIN MACHINE

CLOSE
Note
The NEW SESSION Action key appears following the first dialysis treatment of the day. It
doesnt appear if the dialysis treatment has been interrupted and then restarted using the
Fast Recovery of the Dialysis process procedure. It disappears at the end of the day.
Rev. B
Connect the appropriate acid and bicarbonate (if applicable) concentrates to the
machine. Select the dialysate type Action key to begin uptake of the concentrates into
the machine. The following view is then displayed:
SETUP VIEW:
12:30 SETUP
PRIME TIME pH VALUE

PRIME
DIALYSATE FL. BIC 8.4% COND (Note 1)

PATIENT DATA
VEN ART
BLOOD FLOW
PRIME VOLUME CONDUCTIVITY

STOP SETUP
Note 1
This parameter changes following the selection made in Config/Treatments for the
parameters related to the Action keys ACETATE, BICARB CONC or BICART.
PATIENT DATA (PATIENT DATA/Patient/Rx SELECT):
Access this view to select the personalised prescription parameters. Select the name
of the desired Patient/Rx prescription by pressing one of the seven Selection keys. The
corresponding Patient/Rx parameters are then displayed. Confirm the parameters so
that the machine may use them from the beginning of the preparation process or
modify the parameters by pressing the Set button.
Note
To modify the values of the Patient/Rx parameters press the Set button on the Main
Control Panel. Select the desired parameter by touching the parameter box on the Touch
Screen and change the value by using the PLUS or MINUS buttons, then press
CONFIRM to accept the new value for the parameter. Each parameter must be confirmed
individually.
Rev. B
5.3.1 Standard Dialysis Mode (when SETUP has been selected)
5.3.1.1 When Acetate Dialysate is programmed in the Configuration menu
To start the preparation of Acetate dialysate:
Disconnect the white concentrate connector on the lower front panel of the
machine and connect it to the white concentrate wand, and then place the wand
into in the acetate concentrate container.
Press the SETUP Action key on the IDLE view.
Select the ACETATE Action key on the DIAL. CHOICE view.
The following view is displayed:
12:30 SETUP
PRIME TIME pH VALUE

PRIME
DIALYSATE FL TEMPERATURE
PATIENT DATA
VEN ART
BLOOD FLOW

STOP SETUP
The dialysate preparation process starts.
To stop SETUP, press the STOP SETUP Action key and confirm the operation by
pressing the CONFIRM button on the Main Control Panel. The machine will return to
the IDLE view.
Rev. B
5.3.1.2 When Liquid Bicarbonate Dialysate is programmed in the Configuration

menu
Before pressing the SETUP Action key, ensure that the BiCart holder is in the rinsing
position, with the arms closed (see Fig 5.3, 1)
Note
BICARBONATE 6.6% / 8.4%
The type of liquid bicarbonate concentrate is entered in the Configuration menu.
If the other type of liquid bicarbonate concentrate is required, the BICARB CONC
parameter in the configuration menu must be re-entered
To start the preparation of Liquid Bicarbonate dialysate:

machine and connect it to the white concentrate wand and then place the wand
into the acid concentrate container.
Disconnect the blue concentrate connector on the lower front panel of the
machine and connect it to the blue concentrate wand and then place the wand
into the bicarbonate concentrate container.
Press the SETUP Action key on the IDLE view.
Select the BICARB CONC Action key on the DIAL. CHOICE view.
Note
The type of bicarbonate concentrates to be used on the PHOENIX is described in the
Section 9 Specification, in this manual.
If BIC 6.6% is selected in the configuration menu, the following view is displayed:
12:30 SETUP
PRIME TIME pH VALUE

PRIME

PATIENT DATA
VEN ART
BLOOD FLOW

STOP SETUP
Rev. B
Note 2
This parameter changes following the selection made in Config/Treatments/BICARB
CONC.
To stop setup and to return to the IDLE view, press the STOP SETUP Action key and
confirm the operation by pressing the CONFIRM button on the Main Control Panel.
WARNING
If bicarbonate dialysis is performed:
1. Do not turn off the machine with bicarbonate dialysate in the flow pathway.
2. It is recommended to perform an acetic acid rinse at least twice a week to
remove the calcium and any precipitate residues, which may be deposited in
the hydraulic pathway.
To do this, follow the instructions for the Disinfection process (see Section 6 -
Clean/Disinfect, in this manual), substituting the chemical disinfectant for an acetic
acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to
obtain 400 ml of solution).
Twice weekly rinsing with acetic acid is recommended for machines, which carry out
two bicarbonate dialysis sessions a day.
As required, on the responsibility of the operator, this frequency may be increased or

decreased depending on the following conditions:
Number of bicarbonate dialysis sessions a day.
Quality of water.
Quality of the bicarbonate.
Type of solutions used for chemical disinfection.
WARNING
Ineffective cleaning with acetic acid may cause the machine to malfunction (the
lines or the solenoid valves may block and the sensor readings may be affected).
It is responsibility of the user to check the efficiency of the acetic acid rinsing
procedures and to alter the frequency that they are performed, depending on the
conditions listed above.
Rev. B
5.3.1.3 When BiCart Dialysate is programmed in the Configuration Menu
To start the preparation of BiCart dialysate:
machine and connect it to the white concentrate wand, and then place the wand
into the acid concentrate container.
Note
It is recommended to invert the BiCart before placing it in the BiCart holder.
Note
The BiCart cartridge must be inserted into the BiCart holder before selecting the BICART
Action key. Pressing theBICART Action key initiates priming of the BiCart cartridge.
Open both arms (B, C) of the BiCart holder (see Fig 5.2). To fully open the upper
arm (B), pull the arm out slightly, then tip it upward.
Place the bottom of the BiCart cartridge (D) into the hole in the lower arm (C).
Hold the BiCart in an upright position and press down firmly on the upper arm (B)
of the BiCart holder. The spike inside the hole of the upper arm pierces the top
port of the BiCart (A). At the same time, the BiCart moves downward and the
spike in the lower arm pierces the bottom port. Turn the BiCart by a quarter turn
to place it in working order.
When the DIAL. CHOICE view is displayed, press the BICART Action key to
initiate priming of the BiCart. The following view appears:
12:30 SETUP
PRIME TIME pH VALUE

PRIME

PATIENT DATA
VEN ART
BLOOD FLOW

STOP SETUP
Rev. B
It takes about 1 minute to fill the BiCart with water. If this does not happen, check the
position of the BiCart and verify that both BiCart holder arms are completely pressed
into the BiCart ports.
To stop SETUP and to return to the IDLE view, press the STOP SETUP Action key and
confirm the operation by pressing the CONFIRM button on the Main Control Panel.
A B
Fig 5.2 BiCart holder
Rev. B
WARNING
Check the expiry date on the BiCart label.
Do not refill the BiCart cartridge.
If required to replace the BiCart when a dialysis treatment is in progress, follow the
BiCart Change procedure in the Section 5.A - Special Procedures, in this manual.
IMPORTANT:
Before using the BiCart cartridge, check that it is undamaged.
Store at a temperature lower than 40 C (104 F).
Note
In the event of a Bicart Connector Position #22 alarm, the BiCart priming process will
not start.
Rev. B
1 2 3
Fig 5.3 BiCart connection
Note
In bicarbonate dialysis, at the end of EMPTYING, the machine prompts the operator to
perform a DESCALING, i.e. rinsing of the hydraulic circuit, using either acid concentrate
or vinegar.
DESCALING may be performed with the BiCart cartridge in the BiCart holder if a dialysis
treatment will follow the DESCALING process or with the BiCart removed and the BiCart
holder arms closed.
Rev. B
5.3.2 RX Dialysis Mode

Note
This Section contains references to all the communication software systems to which the
Phoenix machine can be connected, including the Exalis System.
The PATIENT DATA Selection key in SETUP view, when present, allows the selection
of one of the personalised Patient/Rx prescriptions or allows retrieval of the
personalised Patient/Rx prescriptions stored in the Exalis database or allows to assign
an identifier to the treatment data collected by the Communication System.
When the PATIENT DATA Action Key is selected, the PATIENT CHOICE view
appears:
12:30 PATIENT CHOICE
PATIENT MACH
PAT NETWORK

CLOSE
Note
The PAT NETWORK Action key is available only if the SW COMM SYSTEM parameter is
set to Exalis or to OTHER in Config/Communic..
When the the SW COMM SYSTEM parameter is set to Exalis, it indicates that the
Exalis Dialysis Management System is active and can send prescriptions.
When the SW COMM SYSTEM parameter is set to OTHER, it indicates that a
Communication System, other than Exalis or CentryNet or RIMS, can collect treatment
data but cannot send prescriptions. The PAT NETWORK Action key allows to assign a
Patient identifier to a treatment, this assignment will be recognized by the
Communication System.
Note
If the communication between the Exalis System and the machine is interrupted for more
than the time set for the OFFLINE TIMEOUT parameter, the PAT NETWORK Action key
disappears.
Rev. B
By pressing PAT NETWORK a keypad appears allowing the entry of the Patient
Name:
if the SW COMM SYSTEM parameter is set to Exalis, refer to Section 07-
Communication System, for a detailed description of the prescription download
with the Exalis System;
if the SW COMM SYSTEM parameter is set to OTHER, the keypad allows to
assign a Patient identifier to the treatment that will be collected by the
Communication System.
By pressing PATIENT MACH the following PATIENT CHOICE view will appear:
12:30
1ST PATIENT
2ND PATIENT
3RD PATIENT
4TH PATIENT
5TH PATIENT
6TH PATIENT
7TH PATIENT

CLOSE
Note
Before selecting a new personalised Patient (Rx) prescription, deactivate Profiling, if it is
has been already activated.
Press the Action key on the Touch Screen to select the desired prescription Patient
(Rx).
To confirm the selection, press the CONFIRM button on the Main Control Panel as
requested by the message on the Touch Screen.
Note
If the prescription selected is not consistent with the machine features, a superimposed
window appears advising the operator about the error in the patient prescription:
accessory has not
enabled in this machine .
Press ENTER To Confirm And Proceed
The operator must press the CONFIRM button to proceed with the treatment; the portion
of the patient prescription related to the accessory that has not been enabled will be
ignored.
Rev. B
Note
If at least one of the parameters in the patient prescription can not be accepted by the
machine, a superimposed window appears advising the operator about the error in the
patient prescription:
Prescription Not Valid. Please Access the

Machine Page to Check the Wrong Parameter.
Press ENTER To Confirm And Proceed..
The operator must press the CONFIRM button to proceed the treatment; after this
confirmation:
- all of the patient prescription will be discarded;
- if the PAT CONNECT Action key does not become available in the WAIT FOR PT.
CONNECT view, select the PATIENT DATA Action key and then press the CLOSE Action
key to make the PAT CONNECT Action key available.
Entering the Machine view, the WRONG PRESC PAR: parameter displays the prescription
parameter causing the failure.
Note
If the patient prescription selected is not available in the Exalis database, the following
superimposed window appears:
Patient Not Recognized by Clinical Software

Check the Patient Name and retry.
Press ENTER To Proceed
Press the CONFIRM button and repeat the procedure.
Rev. B
When a Patient is selected, some of the relevant dialysis parameters are displayed, as
shown in the following example:
12:30
PARAMETER VALUE PARAMETER VALUE

PARAMETER VALUE PARAMETER VALUE SAFETY PARAMETERS
PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE
Note
When UF PROFILE is active, the DIALYSIS TIME and WEIGHT LOSS/H parameters
are not displayed in the Patient/Rx Safety Parameters Area of the screen.
When COND PROFILE is active, the DIALYSIS TIME and CONDUCTIVITY
parameters are not displayed in the Patient/Rx Safety Parameters Area of the screen.
Rev. B
When the CONFIRM button on the Main Control Panel is pressed the system will
automatically return to the previous view where the PATIENT DATA Selection key
was pressed. If it was the IDLE view, the following view will appear, with the selected
displayed in the RX/Patient Name Area:
12:30 PATIENT 1 IDLE
PATIENT DATA
SETUP
ADR
BPM REPORT CONFIG MACHINE
Rev. B
When programming a Patient treatment:
Before pressing the SETUP Action key, to start the preparation of the dialysate:
Attach the concentrate connectors on the lower front panel of the machine to the
appropriate concentrate containers, according to the type of dialysate selected for
this Patient.
If the type of dialysate is:

ACETATE: follow the instructions in 5.3.1.1
BIC CONC: follow the instructions in 5.3.1.2
BIC BICART: follow the instructions in 5.3.1.3
Press the SETUP Action key.
Note
The parameters list displayed, depends on the specific selections made for the Patient
WARNING
If the machine has detected blood at the Patient Sensor during SETUP, the
following message is displayed:

- Clean and dry venous line and pt. sensor slot
- Put venous line back in the patient sensor
- Press CONFIRM
If the patient is already connected to the machine, disconnect the patient from the
machine.
If there is no patient connected to the machine, this BLOOD detection can be
caused by incorrect placement of the venous line. Press the CONFIRM button
to allow the machine to continue.
Note
If the equipment has detected an incorrect pressure during T1Test, due to improper
Cartridge positioning, the warning message W! Wait for Pressure Test Execution
appears and the following message is displayed:
Please Close the Saline Bag

and Open the Cassette Chambers
to the External Environment
By doing this the pressure decreases and the user can reposition the Cartridge correctly.
Note
When a Patient personalised dialysis is selected, the corresponding Patient name is
displayed in the Patient Name Area in the upper left corner of the screen.
Rev. B
5.4 Preparing for a patient treatment
5.4.1 Dialysate preparation

After pressing one of the Dialysate Selection keys on the DIAL. CHOICE view,
dialysate preparation starts.
During dialysate preparation, the machine carries out the automatic T1 test (see
Section 5.B Test Procedures, in this manual).
12:30 SETUP
PRIME TIME pH VALUE

PRIME

PATIENT DATA
VEN ART
BLOOD FLOW

STOP SETUP
Note
During the T1 test, appropriate messages are displayed in the operator message window.
When no test is occurring, the following message appears:
Wait Dialysate Preparation In Progress...

and a progress bar is displayed informing that the dialysate preparation phase is in
progress.
Note
The parameters on the Touch Screen will differ depending on the type of dialysis therapy
previously selected.
Rev. B
WARNING

Note
During the dialysate preparation phase, the operator may modify some parameters using
the SET button on the Main Control Panel.
Rev. B
5.4.1.1 Possible operations during the dialysate preparation phase
Dialysate Preparation may be interrupted by pressing the STOP SETUP Action key to
return to the IDLE view. The following message will appear:
CONFIRMATION LAST ACTION

MADE
ENTER To Confirm
UNDO
Note
If AutoCalibration of the PA and PB concentrate pumps or the UF pump is necessary
during the dialysate preparation phase, refer to Section 5.A - Special Procedures, in this
manual.
Note
If during the dialysate preparation phase, the machine detects a condition that could
produce a ! Concentrate Cans: A Pump/B Pump/A+B Pumps #40 alarm in the dialysis
treatment in progress, the following superimposed window will appear:
Check the dialysate concentrates to ensure

the usage of the correct concentrate type.
Press UNDO to Cancel the Selection
By pressing the CONFIRM button the machine will perform the PA/PB pump
Autocalibration procedure during the dialysate preparation process, refer to Section 5.A -
Special Procedures. By pressing UNDO, the machine will proceed with the dialysate
preparation process.
Note
If during the dialysate preparation phase, the machine detects that the Blood Pump Cover
is not properly closed, the following message will be displayed in the Operator Message
Area:
Arterial Cover is Open

Please Close it
Only after the Blood Pump Cover has been closed, the Operator Message will disappear
and the machine will proceed with the dialysate preparation process.
5.4.1.2 Sampling of dialysate
A sample can be obtained after the End Of Dialysate Prep, You Can Proceed
message appears refer to Dialysate Sampling in the Section 5.A - Special
Procedures, in this manual.
Rev. B
5.4.2 Priming Mode Selection View

After selecting a dialysate type on the Dialysate Selection view, the following view is
displayed where the priming parameters of the dialyser may be selected:
12:30 SETUP
PRIME TIME pH VALUE

PRIME

PATIENT DATA
VEN ART
BLOOD FLOW

STOP SETUP
Note
In Prime mode, the blood pump runs in the reverse direction (clockwise).
Once the PRIME Selection key appears, open the Waste Handling Option (WHO)
door and insert the white priming connector attached to the arterial line into the
Waste Handling Option drain port (use the pre-connected priming connector).
WARNING
inspection before inserting the Cartridge Blood Sets priming connector into the
port. If fluid is present in the port for more than six seconds after opening the
cover, DO NOT USE the WHO.
WARNING
WARNING
WHO drain port before continuing with another patient treatments or once per
day if the WHO has been in use.
(Refer to Section 5.A - Special Procedures, in this manual).
Rev. B
5.5 Priming of the dialyser
The priming procedure may vary depending on the value set for the DIAL AUTO
PRIME parameter in Config\Centre Conf\Automation.
If the DIAL AUTO PRIME parameter is set to YES, the priming procedure can
start immediately after the appearance of the PRIME Action key (Refer to the
below section 5.5.1 - Priming with Dialysate Connectors on the Dialyser).
If the DIAL AUTO PRIME parameter is set to NO, the priming procedure can
start only when the machine is within proper conductivity (Refer to the below
section 5.5.2 - Priming with Dialysate Connectors on the Rinse Ports).
WARNING
Hemolysis may occur if blood comes in contact with disinfectant remaining in the
blood pathway of dialysers that have not been completely rinsed.
If the dialysers are filled with a chemical disinfectant, special rinsing techniques
must be employed to assure the concentration of disinfectant is reduced and
maintained at an appropriate level. These rinsing procedures are the responsibility
of the medical director. The procedures must include a test of residual disinfectant
and techniques to avoid rebound of disinfectant.
5.5.1 Priming with Dialysate Connectors on the Dialyser
During Dialysate preparation, once the PRIME Action key appears:
Connect the dialysate lines to the dialyser:

Connect the Blue dialysate connector to the inlet dialysate port (blue end) of
the dialyser.
Connect the Red dialysate connector to the outlet dialysate port (red end) of
the dialyser.
Note
The connection of the dialysate lines to the dialyser can be performed during all the
dialysate preparation phase except when the following Operator Message is displayed:
Do Not change Current position of dialysate
connectors until Dialysate Prep. is Complete
This message appears immediately before the end of the dialysate preparation phase.
Once it disappears the dialysate lines can be still connected to the dialyser, if not yet
done.
Rev. B
Press the PRIME Action key, the following view is displayed:
12:30
MANUAL PRIM
PRIME W/ UF
PRIME W/O UF

CLOSE
Select the priming mode.
Select the CLOSE Action key to return to the SETUP PRIME view, if no priming
mode has been selected.
WARNING
When selecting SETUP, the limits of the Venous Pressure alarm window are
automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window
limits are set at -400 to +150 mmHg.
Rev. B
5.5.1.1 To prime the blood side of the dialyser and the heparin line
Note
Before selecting the PRIME Action key, make sure that the saline bag is hanging correctly
on the IV Pole.
Unclamp the saline administration line and the venous and arterial lines.
Depending on the priming mode selected proceed as follows:
if MANUAL PRIM is selected, the following Operator Message is displayed:
Manual Priming is in Progress:

the Blood Pump has to be running
and the BYPASS has to be deselected.
and priming starts as soon as the operator press the ON/OFF button on the
Blood Pump Control Panel. During manual priming mode, the blood pump is
controlled by the operator, it will not start or stop automatically but is
controlled by pressing the blood pump ON/OFF button on the Blood Pump
Control Panel. The pump will start at its minimum preset speed. The operator
can increase or decrease the blood pump speed using the PLUS or MINUS
buttons on the Blood Pump Control Panel. The blood pump must remain ON
until at least 120 ml of saline has been infused and an operator message
appears that indicates that MANUAL PRIM may be stopped.
An operator message will direct the user to the required steps in order to
complete priming.
The UFR is at the UF PRIMING value selected in Config and it is also
adjustable in the SET mode.
Note
The BYPASS Action key remains activated (yellow) during all the priming of the blood side of
the dialyser. To start priming of the dialysate side of the dialyser the BYPASS Action key has
to be manually de-activated (grey).
Note
If the RESUME button was pressed just before selecting the MANUAL PRIM Action key, the
blood pump will start automatically at the selection of the MANUAL PRIM Action key. To
manually control the blood pump speed, use the buttons on the Blood Pump Control Panel.
if PRIME W/ UF is selected, priming will start automatically when the machine

is within proper conductivity. The following Operator Message will appear:

The BYPASS Action Key automatically changes in colour, from yellow to grey,
and the blood pump starts automatically. The blood pump will stop when the
programmed Dialyser Prime Volume has been infused.
The UFR is set at the UF PRIMING value selected in Config and is also
Rev. B
if PRIME W/O UF is selected, the blood pump starts automatically

immediately after the Action key selection and will stop when the
programmed Dialyser Prime Volume has been infused.
When the machine is within proper conductivity and the following Operator
Message will appear

the BYPASS Action Key automatically changes in colour, from yellow to grey.
NO UFR is performed.
Note
In the Prime mode, the blood pump turns in the reverse (clockwise) direction.
Note
A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal
circuit deaereation.
Note
If set up for Single Needle and a Single Needle treatment is programmed, perform prime
as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT
(refer to Dialysis change mode).
Priming of the heparin line starts automatically at the start of the blood side
priming, if the parameter PRIMING HEP is set to YES in the Config screen.
Note
To prime the heparin line, access the Heparin view by pressing the Heparin Navigation
key. From this view the HEPARIN PR Action key may be pressed to activate priming. An
icon indicating the activation of the heparin pump appears on the icon bar. The syringe
containing heparin must be correctly installed prior to the time of the HEPARIN PR
selection.
Observe the dialyser and Cartridge Blood Set.

Check/adjust the fluid level in the venous and arterial chambers, refer to Level
adjustment of the Cartridge chambers.
Rev. B
5.5.1.2 To fill the dialysate side of the dialyser
If MANUAL PRIM has been selected, deselect/deactivate the BYPASS Action key
on the SETUP: PRIME/PREPARATION view to prime the dialysate side of the
dialyser.
WARNING
If performing MANUAL PRIM or PRIME W/O UF, priming of the blood side may
be performed before priming the dialysate side. Dialysate side priming may be
started before blood side priming is complete.
Note
If PRIME W/ UF or PRIME W/O UF has been selected, during dialysate side priming the
following message appears:
Wait, Priming in progress
and a progress bar is displayed informing that the dialysate side priming phase is in
progress.
The end of the dialysate side priming is signaled by the appearance of the RECIRC
Action key.
When priming is complete, the RECIRC Action key will become available to initiate
the recirculation phase prior to patient connection.
Note
The selection/activation of the PRIME Action Key allows the operator to re-start priming. If
the PRIME Action key is deselected/deactivated before the end of the dialysate side
priming, the RECIRC Action key becomes available.
Rev. B
5.5.2 Priming with Dialysate Connectors on the Rinse Ports
When the machine is within proper conductivity, the following Operator Message will
appear:

and the following view is displayed:
12:30 SETUP PRIME
PRIME TIME PH VALUE

PRIME
DIALYSATE FL. BIC 8.4% COND (NOTE 1)

PATIENT DATA
VEN ART
BYPASS
BLOOD FLOW

PAT CONNECT

STOP SETUP
WARNING
When selecting SETUP, the limits of the Venous Pressure alarm window are
automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window
limits are set at -400 to +150 mmHg.
Note
The PAT CONNECT Action key is available only if the JUMP PRIMING parameter is set to
YES in Config/Centre Conf/Functions.
Rev. B
Note
If the machine is connected to the CentryNet system, the PAT CONNECT Action key is
available only after the START COLLECT Action key has been pressed.
Connect the dialysate lines to the dialyer.
Connect the Blue dialysate connector to the inlet dialysate port (blue end) of the
dialyser.
Connect the Red dialysate connector to the outlet dialysate port (red end) of the
dialyser.
5.5.2.1 To prime the blood side of the dialyser and the heparin line
Note
Before selecting the PRIME Action key, make sure that the saline bag is hanging correctly on
the IV Pole.
Unclamp the saline administration line and the venous and arterial lines.
When the PRIME Selection key is pressed the following view is displayed:
12:30
MANUAL PRIM
PRIME W/ UF
PRIME W/O UF

CLOSE
Rev. B
Select the priming mode:
if MANUAL PRIM is selected, the blood pump is controlled by the operator.

After the selection of the MANUAL PRIM Action key, the following Operator
Message is displayed:
Manual Priming is in Progress:

the Blood Pump has to be running
and the BYPASS has to be deselected.
The blood pump will not start or stop automatically but is controlled by
pressing the blood pump ON/OFF button on the Blood Pump Control Panel.
The pump will start at its minimum preset speed. The operator can increase or
decrease the blood pump speed using the PLUS or MINUS buttons on the
Blood Pump Control Panel. The blood pump must remain ON until at least
120 ml of saline has been infused and an operator message appears that
indicates that MANUAL PRIM may be stopped.
An operator message will direct the user to the required steps in order to
complete priming.
The UFR is at the UF PRIMING value selected in Config and it is also
if PRIME W/ UF is selected, the BYPASS Action Key automatically changes in

colour, from yellow to grey, and the blood pump starts automatically. The
blood pump will stop when the programmed Dialyser Prime Volume has
been infused.
The UFR is set at the UF PRIMING value selected in Config and is also
if PRIME W/O UF is selected, the blood pump starts automatically and will
stop when the programmed Dialyser Prime Volume has been infused.
NO UFR is performed.
Select the CLOSE Action key to return to the SETUP PRIME view, if no priming
mode has been selected.
Note
In the Prime mode, the blood pump turns in the reverse (clockwise) direction.
Note
A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal
circuit deaereation.
Note
If set up for Single Needle and a Single Needle treatment is programmed, perform prime
as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT
(refer to Dialysis change mode)
Rev. B
Priming of the heparin line starts automatically at the start of the blood side
priming, if the parameter PRIMING HEP is set to YES in the Config screen.
Note
To prime the heparin line, access the Heparin view by pressing the HeparinNavigation key.
From this view the HEPARIN PR Action key may be pressed to activate priming. An icon
indicating the activation of the heparin pump appears on the icon bar. The syringe
containing heparin must be correctly installed prior to the time of the HEPARIN PR
selection.
Observe the dialyser and Cartridge Blood Set.

Check/adjust the fluid level in the venous and arterial chambers, refer to Level
adjustment of the Cartridge chambers.
5.5.2.2 To fill the dialysate side of the dialyser
If MANUAL PRIM or PRIME W/O UF has been selected, deselect/deactivate the

BYPASS Action key on the SETUP PRIME/PREPARATION view to prime the
dialysate side of the dialyser.
WARNING
If performing MANUAL PRIM or PRIME W/O UF, priming of the blood side may
be performed before priming the dialysate side. Dialysate side priming may be
started before blood side priming is complete.
Note
If PRIME W/ UF or PRIME W/O UF has been selected, during dialysate side priming the
following message appears:
Wait, Priming in progress
and a progress bar is displayed informing that the dialysate side priming phase is in
progress.
The end of the dialysate side priming is signaled by the appearance of the RECIRC
Action key.
When priming is complete, the RECIRC Action key will become available to initiate
the recirculation phase prior to patient connection.
Note
The selection/activation of the PRIME Action Key allows to re-start priming. If the PRIME
Action key is deselected/deactivated before the end of the dialysate side priming, the
RECIRC Action key becomes available.
Rev. B
5.6 Recirculation
5.6.1 Prepare to perform recirculation

a. Clamp the heparin line, venous and arterial lines and the saline administration line.
b. Disconnect the saline administration line from the venous line and connect it to
the Cartridge saline line utilizing the white priming connector on the Cartridge
saline line. Ensure the saline administration line is still clamped.
c. Remove the arterial line from its priming connector, leaving the priming connector
in the WHO drain port.
Note
If the arterial line is removed from the Waste Handling Option with the white priming
connector attached, there is danger of contaminating the arterial line with fluid that has
been in contact with the Waste Handling Option. To prevent contamination of the arterial
line, always disconnect the arterial line from the white priming connector in the WHO
drain port.
d. Connect the venous and arterial lines together utilizing the white priming
connector on the venous line.
e. Remove the white priming connector from the Waste Handling Option drain port
and discard it. Close the Waste Handling Option door. If the WHO door remains
open at the activation of the RECIRC phase, the alarm message WHF Door
Positioning (#326) will appear, the Blood Pump will stop. The recirculation timer
(RECIRCULATION TIME parameter) will be stopped while the Waste Handling
Option door remains open.
WARNING
5.6.1.1 Unclamp lines
Unclamp the venous and arterial lines, the saline administration line, and the Cartridge
saline line clamps.
5.6.2 Select Recirculation

a. Pressing the RECIRC Action key automatically starts the blood pump. The blood
pump will run at the pump speed value previously set for the RECIRC B FLOW
parameter. (Refer to Section 02 Configuration, for details about the RECIRC B
FLOW parameter setting). Recirculation continues for the time set in the
RECIRCULATION TIME parameter. When the time has elapsed the blood pump
continues to run in the forward direction (counter-clockwise) and the UFR stops
until Patient Connection.
Note
During the Recirculation phase, the PRIME, BYPASS and PAT CONNECT Action keys are
not available.
Rev. B
b. Use the PLUS or MINUS buttons on the Blood Pump Control Panel to adjust the
blood pump speed during RECIRC.
c. Set a UF PRIMING to greater than 0.1 l/h to prevent saline from flowing
backwards into the saline administration line.
d. Recirculate according to your facilitys protocol. To stop RECIRC and stop the
blood pump, press the RECIRC Action key.
5.7 Level adjustment of the Cartridge chambers
Level Adjustment without using syringe in Double Needle Treatment
Adjust the fluid level in the venous Cartridge chamber by aseptically opening both the
white cap on the venous access line and the blue clamp on the 4 Position Line Clamp,
with the blood pump ON in the forward (counter-clockwise) direction. When the
target level is reached, close the blue clamp and replace the white cap on the venous
access line.
During the PRIME mode the fluid level in the arterial Cartridge chamber may be
adjusted with the blood pump ON in the reverse (clockwise) direction, by aseptically
opening both the white cap on the arterial Cartridge access line and the right red
clamp on the 4 Position Line Clamp. When the target level is reached, close the right
red clamp and replace the white cap on the arterial access line.
To adjust the fluid level in the arterial Cartridge chamber, when not in the PRIME
mode, turn the blood pump OFF and then aseptically open both the white cap on the
arterial Cartridge access line cap and the right red clamp on the 4 Position Line
Clamp. When the target level is reached, close the right red clamp and replace the
white end cap.
Note
The fluid level in the chambers (arterial or venous) should be stabilized at approximately
the bottom of the pressure pod.
The target fluid level in the chambers is indicated by a frosted line on the chamber
themselves.
Level Adjustment using syringe in Double Needle Treatment
To adjust the fluid level in the venous Cartridge chamber open the white cap on the
venous access line, connect a sterile syringe to the venous access line and open the
blue clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate until the
target level is reached, then close the blue clamp, remove the syringe and replace the
white cap on the venous access line.
To adjust the fluid level in the arterial Cartridge chamber, open the white cap on the
arterial Cartridge access line, connect a sterile syringe to the arterial access line and
open the right red clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate
until the target level is reached, then close the right red clamp, remove the syringe
and replace the white cap on the arterial access line.
Rev. B
Note
The fluid level in the chambers (arterial or venous) should be stabilized at approximately the
bottom of the pressure pod.
The target fluid level in the chambers is indicated by a frosted line on the chamber
themselves.
Level Adjustment in Single Needle Treatment
Adjust the level in the pre and post dialyser expansion chambers and be sure that the
clamp above the pre-dialyser expansion chamber and the clamp below the post-
dialyser expansion chamber are closed.
To perform the procedure, follow the instructions in the Level Adjustment using
syringe in Double Needle Treatment paragraph by operating on the pre and post
dialyser expansion chambers.
Note
The fluid level in the expansion chambers (pre and post dialyser) should be stabilized at
approximately 1/3 of the height of the expansion chambers.
Rev. B
5.8 Patient Connection

5.8.1 Ready for patient connection
After prime is complete the following view is displayed:
12:30 SETUP WAIT

PATIENT
RECIRCULATION TIME RECIRCULATION UF

PRIME
RECIRC
DIALYSATE FL. BIC 8.4% COND (NOTE 1)

PATIENT DATA
VEN ART
BYPASS
BLOOD FLOW

PAT CONNECT
CHANGES
STOP SETUP
Note
During the initial DIASCAN Autocalibration, the BYPASS Action key is not available (see
Section 5.E Monitoring, in this manual).
Note
If the CURVE TYPE parameter or/and the CON CURVE TYPE parameter is(are) set to STEP
or to PROGRESSIVE, the PAT CONNECT Action key becomes available only if the
corresponding Profile curve(s) has/have been activated ACTIVATE (UF RATE CURVE
or/and the ACTIVATE CONDUCT. CURVE Action key(s) selection). Refer to Section 5.D
Profile, in this manual.
WARNING
If using a dialyser that has been filled with a chemical disinfectant, proceed as follows:
Verify that the level of residual chemical disinfectant in the extracorporeal circuit
is acceptable according to your facilitys protocol or to the instructions for use of
the disinfectants manufacturer.
When the residual level is acceptable, discard the rinse saline bag and attach a
new bag of saline. If the residual level is unacceptable, proceed according to your
facilitys protocol.
Before initiating dialysis flush the administration set and the entire extracorporeal
circuit with fresh saline according to your facilitys protocol.
Rev. B
Once all the preparations and settings have been completed and the patient is ready,
the operator can select the PAT CONNECT Action key, confirm the selection pressing
the CONFIRM button and then proceed to connect the patient.
WARNING
When performing dialysis treatment for patients with a body weight of less than 40
kg, special attention should be given to the dialysate flow rate setting. To mitigate
the risk of excessive weight removal, it is recommended to set the DIALYSATE FL.
parameter to a value lower than or equal to 500 ml/min.
Note
If the presence of blood has already been detected at the Patient Sensor the machine
automatically goes to the PAT CONNECT view (see Initiating patient connect).
Note
When Profiling has not been activated, these parameter values must always be confirmed:
DIALYSIS TIME
TOT WEIGHT L
WEIGHT LOSS/H
If these values are not confirmed, a confirmation request is displayed in the Operator
Message Area and the PAT CONNECT Action key will not appear.
When UFR Profiling has been activated, the TOT WEIGHT L parameter value must always
be confirmed in the PROFILE/UF view to make the PAT CONNECT Action Key available.
Refer to Section 5.D - Profile.
Note
In case of error in the retrieval of the RX prescription from an external communication
software system (Refer to Section 7.5.3, Error Messages related to Computer Prescription,
for details about the error message displayed in case of failure), the PAT CONNECT
Action key might not be displayed. To make the PAT CONNECT Action key available,
select the PATIENT DATA Action key and then press the CLOSE Action key.
Note
When Profiling is active, the END DIALYSIS parameter can not be modified.
Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the
current dialysis prescription.
The END DIALYSIS parameter becomes again available at Profiling deactivation (Refer to
Section 05.D Profile, for a detailed description of Profiling deactivation conditions).
Note
The DIALYSIS TIME, TOT WEIGHT L and WEIGHT LOSS/H parameters have to be
confirmed following the listed sequence. To allow the operator to confirm them in the
right order, they are automatically selected in sequence.
Note
If the machine is connected to the CentryNet system, the DIALYSIS Action key is available
only after the START COLLECT Action key has been pressed.
Rev. B
5.8.2 Heparinization
By pressing the Heparin Navigation key the following view will appear:
12:30
SYRYNGE TYPES
LINEAR
AUTO BOLUS
PARAMETER 1 (NOTE 3) PARAMETER 2 (NOTE 3)
MAN BOLUS
VEN ART
BLOOD FLOW PARAMETER 3 (NOTE 3) PARAMETER 4 (NOTE 3)

BOLUS ON
HEPARIN PR
BLOOD FLOW
Note 3
These parameters are displayed only if the heparin delivery type has been selected by
pressing the LINEAR or AUTO BOLUS or MAN BOLUS Action key.
In the case of:
LINEAR
Parameter 1 = PRE STOP TIME
Parameter 2 = HEPARIN RATE
Parameter 3 = INITIAL BOLUS
Parameter 4 = HEPARIN TOTAL
AUTO BOLUS
Parameter 1 = PRE STOP TIME
Parameter 2 = HEPARIN BOLUS
Parameter 3 = BOLUS INTERVAL
MAN BOLUS
Parameter 1 = MANUAL BOLUS
If this view is accessed during the PRIME mode, the operator can initiate the priming
of the heparin line by pressing the HEPARIN PR Action key. At this point the heparin
pump injects a fixed quantity of heparin into the line. Or, priming of the heparin line
starts automatically at the start of the blood side priming if the parameter PRIMING
HEP is set to YES in Config/Centre Conf/Automation.
Rev. B
The HEPARIN PR Action key is available only during the dialyser prime and the
dialyser change.
The volume injected is equivalent to the volume of the heparin line on the Cartridge
Blood Set.
The heparin delivery type can be selected by pressing one of the following Action
keys:
LINEAR: heparinization is continual during the treatment at the HEPARIN RATE set. In
this mode, a programmable quantity (initial bolus) of heparin can be injected before
starting the continual heparinization. To do this, the user must set a value for the
INITIAL BOLUS parameter before starting the treatment.
Pressing the LINEAR Action key disables the AUTO BOLUS and MAN BOLUS Action
keys.
AUTO BOLUS: a heparin bolus is delivered by the machine at a fixed time interval.
The quantity of the bolus corresponds to the value set for the HEPARIN BOLUS
parameter, while the timing corresponds to the value set for the BOLUS INTERVAL
parameter.
Pressing the AUTO BOLUS Action key disables the LINEAR and MAN BOLUS Action
keys.
MAN BOLUS: a heparin bolus is delivered every time the BOLUS ON Action key is
pressed. The quantity of the bolus corresponds to the value set for the MANUAL
BOLUS parameter.
Pressing the MAN BOLUS Action key disables the LINEAR and AUTO BOLUS Action
keys.
During treatment, the HEPARIN TOTAL parameter displays the volume of heparin
infused to the patient.
The HEPARIN TOTAL parameter value for a treatment remains available:
-until the machine switch off at the end of treatment;
-until the selection of the heparinization delivery type for the next treatment, if the
machine is not switched off between two subsequent dialysis treatments.
Once the heparinization delivery type is selected and the appropriate Action key
pressed, the corresponding heparin icon appears on the left side of the Touch Screen,
on the Icon bar, indicating that the mode is activated.
The Heparin Pump will start in patient connection.
To return to the previous view press the Home icon Navigation key.
Rev. B
5.8.3 Initiating patient connect

The machine is ready for patient connection. Press PAT CONNECT, the blood pump
stops automatically to allow connection of the patient to the machine. Press the blood
pump ON/OFF button to restart the blood pump if the patient is not yet available.
The following view appears on selection of PAT CONNECT:
12:30 PATIENT
CONNECT
DIALYSIS TIME WEIGHT LOSS/H
TOTAL FLUID REMOVED TOT WEIGHT L

VEN ART
BLOOD FLOW
TOTAL BLOOD CONDUCTIVITY

CHANGES
BLOOD FLOW
To access the BPM view press the BPM Navigation key.

Proceed with the patient connection to the machine according to the facilitys
protocol.
5.8.3.1 Fill the extracorporeal circuit with fresh saline prior to treatment
a. Clamp the venous and arterial lines and disconnect them from each other leaving
the priming connector on the venous line.
b. Place the arterial line over a collecting basin, being careful not to contaminate the
line.
c. With the blood pump OFF, open the clamps on the saline administration line,
Cartridge saline line and the arterial line.
d. Allow approximately 60 ml of saline to run out of the saline bag, through the
arterial chamber and arterial line into the collecting basin. Clamp the arterial line.
e. Being careful not to contaminate the line, connect the arterial line to the patients
arterial access. Leave both lines clamped.
Rev. B
f. Insert the priming connector on the venous line into the Waste Handling Option
drain port. Press the blood pump ON/OFF button to start the blood pump and
immediately open the clamp on the venous line.
Note
The Heparin Pump will start after a minimum value (20 ml) of TOTAL BLOOD has been
reached.
g. Flush the remaining extracorporeal circuit with enough saline to replace the
recirculated saline it contains. DO NOT let air enter the lines.
h. When enough saline has been allowed to flush the extracorporeal circuit, press the
blood pump ON/OFF button to stop the blood pump and clamp the venous line.
WARNING
inspection before inserting the Cartridge Blood Set priming connector into the
port. If fluid is present in the port more than six seconds after opening the cover,
DO NOT USE the Waste Handling Option.
5.8.3.2 Connect patient
Note
The steps below give instructions for connecting the patient and discarding the prime. The
venous line is still connected to the Waste Handling Option drain port.
a. Verify that there are no active alarms (check the alarm display area of Touch
Screen); unclamp the heparin line.
b. Clamp the saline administration line and Cartridge saline line.
c. Unclamp the arterial line and the patients arterial access. Press the blood pump
ON/OFF button to start the blood pump (blood begins filling the arterial line and
chamber).
d. Unclamp the venous line. When blood enters the venous chamber, simultaneously
clamp the venous line and press the blood pump ON/OFF button to stop the
blood pump. Once the Patient Sensor detects blood in the venous line, an alarm
W! Blood in the Venous Line will be given and the blood pump will stop.
OVERRIDE this alarm to continue.
e. Disconnect the venous line from the white priming connector, leaving the white
priming connector in the Waste Handling Option.
f. Being careful not to contaminate the line, connect the venous line to the patients
venous access. Unclamp the venous line and the patients venous access.
g. Remove the white priming connector from the WHO and discard it. Close the
Waste Handling Option door.
Note
The DIALYSIS Action Key will not appear until the Waste Handling Option door is closed.
Rev. B
Note
From the moment that blood is detected in the venous line at the Patient Sensor the
Patient Sensor icon appears to indicate the presence of blood.
WARNING
From the moment that blood is detected in the venous line at the Patient Sensor to
the WASHBACK phase, if the operator stops the Blood Pump pressing the ON/OFF
button on Blood Pump Control Panel:
The venous pressure alarm window lower limit is automatically set to +10
mmHg and the upper limit is set to the VEN PRES LIMIT parameter value
decreased of 50 mmHg (see Section 2 - Configuration Description, in this
manual).
The arterial pressure alarm window lower limit is automatically set to the value
set for the MIN ART PRESSURE parameter increased of +50 mmHg and the
upper limit is set to +150 mmHg.
WARNING
Once the patient has been connected, do not open the Blood Pump Cover unless it
is required by special procedures described in this manual (i.e., Diaphragm Neutral
Position Procedure); in this case strictly follow these procedures.
Opening of the Blood Pump Cover without following procedures described in this
manual may infuse air to the patient through the arterial line causing patient injury
or death.
The DIALYSIS Action Key is displayed:
12:30 PATIENT
CONNECT

DIALYSIS

VEN ART
BLOOD FLOW
TOTAL BLOOD CONDUCTIVITY

CHANGES
BLOOD FLOW
Rev. B
Note
If a Patient Dialysis is performed and the Communication System is Exalis, once the
patient connection has been made, the machine sends to the Exalis database the name of
the patient that has been connected.
If the name of the patient sent to the Exalis Communication System is not present in the
Exalis database, the following superimposed window appears:
Patient Not Recognized by Clinical Software.

To retrieve the current treatment data, ,
Link manually the patient in Exalis.
Press the CONFIRM button to proceed with the treatment. Refer to the Exalis Operators
Manual for the procedure of how to link manually the patient in the Exalis database.
Once the patient connection has been made, select the DIALYSIS Action key to start
the dialysis treatment. The blood pump will start:
at the speed value set for the INIT DIAL B FLOW parameter, if the RAMPING
TIME parameter is set to 0.
at 50 ml/min, if the RAMP TIME parameter is set to a value different from 0. In
this case the blood pump will automatically reach the pump speed value set for
the INIT DIAL B FLOW parameter in a interval time equal to the value set for the
RAMPING TIME parameter. During this Automatic Gradual Ramping time
period the PLUS and MINUS button on the Blood Control Panel are not active.
WARNING
due to the reduced efficacy of the Protective System; these must be carried out
under the control of the user and are the responsibility of the user.
Rev. B
5.8.4 Dialysis change mode: Single Needle and Double Needle mode
Pressing the CHANGES Selection key, from the PATIENT CONNECT view, where it is
available, allows the user to change the operating mode of the blood module.
12:30 CHANGES
CHANGE TO SN
CHANGE TO DN
FILTER CHANGE
VEN ART
PAUSE BICART
BLOOD FLOW
BICART PRIM.
TOTAL BLOOD CONDUCTIVITY CHANGE TO LIQ

BIC
BLOOD FLOW
CHANGE ACID

CLOSE
Note
The BICART PRIM. Action key does not appear until the PAUSE BICART Action key has
been pressed.
CHANGE TO SN and CHANGE TO DN Action keys are only displayed if Single

Needle is set to YES in Config/MACHINE /Accessories.
The possible transitions depend on the starting conditions, since in DN only the DN >
SN key is enabled, while in SN only the SN > DN key is enabled.
From Double Needle DN > SN

From Single Needle SN > DN
CLOSE allows the user to return to the previous view.
Rev. B
5.9 Dialysis
5.9.1 Performing Dialysis

When the DIALYSIS Action key is selected, the following view is displayed:
12:30 TREATMENT
DIALYSIS TIME DIFFUSION TIME

BYPASS
UF ONLY

WLR MINIMUM
VEN ART
BLOOD FLOW
WEIGHT LOSS/H TOTAL BLOOD

CHANGES
BLOOD FLOW

WASHBACK
This view remains until the end of dialysis.
CHANGES allows the operator:

to change the operating mode of the blood module as described in the Dialysis
Change Mode Section;
to temporarily disconnect the Patient (Refer to Section 05A Special Procedures,
in this manual, for the description of the PAUSE THERAPY procedure);
to change the BiCart if it becomes empty during the treatment (Refer to Section
05A Special Procedures, in this manual, for the description of the BiCart Change
procedure);
to replace the dialyser (Refer to Section 05A Special Procedures, in this manual,
for the description of the Dialyser Replacement procedure);
to switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate
concentrate (Refer to Section 05A Special Procedures, in this manual, for the
description of the CHANGE TO LIQUID BICARB procedure);
to change the Acid/Acetate Concentrate Supply (Refer to Section 05A Special
Procedures, in this manual, for the description of the CHANGE ACID procedure).
Rev. B
Note
When an Patient/Rx Personalised Treatment is performed, the name of the dialysis type in
the view above is replaced with the Patient/Rx name.
Note
During DIALYSIS, the icons relative to the treatment appear in the Icon bar.
Note
In the event of a ! Concentrate Cans: A Pump or B Pump or A+B Pumps alarm during a
treatment, it is possible to carry out a recalibration: refer to Section 5.A - Special
Procedures, in this manual.
When a critical condition for the patient arises, the operator can use three emergency
functions.
Minimum UF Rate: when selecting the WLR MINIMUM Action key, the hourly
ultrafiltration rate is set to the minimum value selected in Config, i.e., a value
between 0.0 and 0.3 kg/h.
When selected, the Action key is highlighted.
Dialysate Flow in Bypass: when pressing the BYPASS Action key, the flow through
the dialyser is interrupted. When selected, the Action key is highlighted:
12:30 TREATMENT

BYPASS

WLR MINIMUM
VEN ART
BLOOD FLOW

CHANGES
BLOOD FLOW

WASHBACK
Rev. B
Note
If the operator has selected BYPASS for 7 minutes during the dialysis process, the alarm !
Bypass Wrongly Extended (#302) appears.
Pressing the BYPASS Action key again will restart the normal dialysis process:
The dialysate flow through the dialyser is restarted.
The BYPASS Action key is no longer highlighted
Ultrafiltration Only: The dialysate flow through the dialyser may be interrupted by
pressing the UF ONLY Action key. The following confirmation request will appear:
CONFIRMATION LAST ACTION

MADE
ENTER To Confirm
UNDO
By pressing the Confirm button the Action key becomes highlighted and the BYPASS
Action key disappears indicating that the function is no longer selectable.
12:30 TREATMENT
UF ONLY

WLR MINIMUM
VEN ART
BLOOD FLOW

CHANGES
BLOOD FLOW

WASHBACK
Rev. B
By pressing the UF ONLY Action key again, the above confirmation request will
appear.
After pressing the Confirm button the normal dialysis process restarts:
The dialysate flow through the dialyser is restarted.
The UF ONLY Action key is no longer highlighted.
The BYPASS Action key reappears.
To disconnect the patient, select WASHBACK.
Rev. B
5.10 End of Dialysis
5.10.1 Patient disconnection and Emptying dialyser

Select the WASHBACK Action key.
In this mode:
The blood pump stops to allow disconnection of the patient and to enable the
Washback of blood from the extracorporeal circuit to the patient.
The patient may then be disconnected from the machine according to the facilitys
protocol.
WARNING
When WASHBACK is selected, the limits of the Venous Pressure alarm window are
automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure
window are set to the value set for the MIN ART PRESSURE parameter increased of
+50 mmHg and +150 mmHg.
These values are maintained for the duration of the WASHBACK mode.
WARNING
When WASHBACK is selected, the heparin pump is stopped.
When selecting WASHBACK, the following view is displayed:
12:30 WASHBACK
EMPTYING

VEN ART
BLOOD FLOW
RINSEBACK VOLUME TOTAL BLOOD

CHANGES
BLOOD FLOW

TREATMENT
Rev. B
Note
During WASHBACK, the UFR parameter value is 0.
The different Selection/Action keys available on this view allow access to particular
procedures:
EMPTYING Action Key allows emptying of the dialyser following

WASHBACK.
CHANGES Selection key gives access to another view where PAUSE BICART,
FILTER CHANGE, CHANGE TO LIQ BIC, CHANGE
ACID and DIALYSIS MODE CHANGE are available
Note
The DIALYSIS MODE on the CHANGES view allows WASHBACK in a different dialysis
mode to that that used during dialysis (e.g. Single Needle to Double Needle).
TREATMENT allows the operator to return to DIALYSIS.

When the RINSEBACK VOLUME value set has been
reached, the TREATMENT Action key disappears and
it is no longer possible to return to dialysis.
Note
When the RINSEBACK VOLUME value set has been reached and the DIALYSIS Action
key disappears, the POST STANDING, POST SITTING and POST LYING Action keys
becomes available.
If selecting one of the three Action keys (POST STANDING/POST SITTING/POST LYING)
before the EMPTYING Action key selection, the Dialyser Replacement procedure will be
no more allowed for the current dialysis treatment.
WARNING
The FILTER CHANGE Action key must be used only when the dialyser needs to be
replaced (Refer to Dialyser replacement in the Section 5.A - Special Procedures
in this manual).
WARNING
Only in the event of the ! Concentrate Cans: A Pump or B Pump or A+B Pumps
(#40) alarm is it possible to perform Autocalibration of PA or PB pump during
DIALYSIS (see Autocalibration procedure for the peristaltic pumps during dialysis
in the Section 5.A - Special Procedures) when the operator accesses the Machine
view by pressing the Machine Navigation key.
WARNING
due to the reduced efficacy of the Protective System; these must be carried out
under the control of the user and are the responsibility of the user.
Rev. B
5.10.2 Emptying the dialyser
5.10.2.1 Manual Emptying
At the end of the WASHBACK procedure, the EMPTYING and the AUTOEMPTY (if
activated) Action key are available.
The selection of EMPTYING acts as a confirmation to the machine that the patient has
been disconnected.
WARNING
In order to verify that the patient has been disconnected properly, the following
message is displayed when the operator presses the EMPTYING Action key the first
time:
WARNING!
Ensure that the patient has been disconnected.
Press CANCEL otherwise.
Press CONFIRM to proceed with emptying.
Press the CONFIRM button on the Main Control Panel to continue. The blood
pump stops and the Protection System is no longer active.
After the selection of EMPTYING, the dialysate side of the dialyser is now emptied by
the machine and the following view is displayed:
12:30 EMPTYING
TOTAL FLUID REMOVED TOTAL BLOOD
EMPTYING
HEPARIN TOTAL DESCALING TIME

STOP RINSE
VEN ART
AUTO EMPTYING
BLOOD FLOW
VINEGAR DESCAL
BLOOD FLOW
DESCALING
BPM REPORT KT/V MACHINE

FINAL RINSE
Rev. B
Note
Only after the EMPTYING mode has been completed and if a bicarbonate dialysis has
been performed, the descaling function (VINEGAR DESCAL and DESCALING Action key)
becomes available.
In particular, if the VINEGAR DESCAL parameter in Config is set to NO, the VINEGAR
DESCAL Action key is not available; if the VINEGAR DESCAL parameter in Config is set to
YES both the VINEGAR DESCAL and the DESCALING Action key are available. If the
VINEGAR DESCAL parameter in Config is set to ALWAYS, only the VINEGAR DESCAL
Action key is available.
Note
Only after the EMPTYING mode has been completed, the STOP RINSE Action key
becomes available.
Note
Only after the EMPTYING mode has been completed and if an Acetate dialysis has been
performed, the FINAL RINSE Action key becomes available.
The AUTO EMPTYING Action key allows to proceed with emptying procedure using
the AutoEmptying feature. Refer to 5.10.2.2 AutoEmptying, in this section, for a
detailed description of the AutoEmptying feature.
To proceed with EMPTYING without using the AutoEmptying feature:
Rotate the dialyser so that the blue end of the dialyser is up.
Disconnect the blue dialysate connector from the dialysate port of the dialyser and
reattach it to its bypass port on the machine. (This operation is prompted by an
operator message).
Deselecting EMPTYING allows the EMPTYING process to be interrupted.

This Action key disappears when the dialyser has been emptied.
Disconnect the red dialysate connector from the dialysate port of the dialyser and
reattach it to its bypass port on the machine. (This operation is prompted by an
operator message).
WARNING
In bicarbonate dialysis, it is strongly recommended to perform a descaling of the
hydraulic circuit with vinegar following every treatment. This can be done using the
VINEGAR DESCAL Action key. Its duration may be set with the DESCALING TIME
parameter. During this phase the value of the DESCALING TIME parameter is
displayed.
Rev. B
If another dialysis treatment is going to be performed, the concentrate connectors

(Acid and bicarbonate/BiCart) may be left in place on the machine during the
DESCALING and FINAL RINSE processes. If another dialysis treatment will not be
performed:
Liquid Bicarbonate - remove the blue bicarbonate connector from the blue
concentrate wand and reinsert it into its blue rinse port on the machine.
BiCart - remove the BiCart cartridge from its holder and close the BiCart Holder
arms.
Remove the Acid/Acetate connector from the white concentrate wand and
reinsert it into its red rinse port on the machine.
Note
The FINAL RINSE is performed even if the acid connector has not yet been positioned in
its rinse port.
Rev. B
5.10.2.2 AutoEmptying
To proceed with AutoEmptying:
Leave the blue and red dialysate connectors on the dialyser.

Venous and arterial lines must be connected together in the same configuration as
used for RECIRC and the lines unclamped.
Open the left red clamp (on the Cartridge saline line) in the 4-Position Line Clamp.
Ensure the saline administration line is not clamped.
Select the AUTO EMPTYING within 20 seconds Action key to start the procedure.
Note
The AUTO EMPTYING Action key is only available if the AUTOEMPTYING parameter in
Config is set to YES.
Note
In the case of bicarbonate dialysis, upon selecting the AUTO EMPTYING Action key, a
DESCALING procedure is automatically performed. If the VINEGAR DESCAL parameter
in Config is set to ALWAYS, the machine will perform the DESCALING procedure with
vinegar.
If the End of WashBack Procedure #332 alarm is present, press the OVERRIDE
button to clear the alarm.
The blood pump starts automatically at 100 ml/min (this is indicated by the
flashing light on the Blood Pump Control Panel). The blood pump speed can not
be modified.
Wait until the following Operator Message is displayed:
AutoEmptying Procedure has Been Interrupted
and Open in Air the Venous Chamber
then open the blue clamp (on the Venous access line) in the 4-Position Line
Clamp to allow air to enter the extracorporeal circuit.
During AutoEmptying it is possible to stop the procedure by deselecting the AUTO

EMPTYING Action key.
When the Cartridge Blood Set and blood side of the dialyser are empty, press the
AUTO EMPTYING Action key to deactivate it. The AUTO EMPTYING Action key will
disappear.
The emptying procedure can continue in order to empty the dialysate side; to do this:
When the value set for the DESCALING TIME parameter is elapsed, the following
Operator Message is displayed:
You Can Replace The Blue Dialys. Connector
All Connectors Must Be Replaced
Leave A Connector In Concentrate
Disconnect the blue dialysate connector from the dialysate port of the dialyser and
reattach it to its bypass port on the machine. (Do not disconnect the red dialysate
connector, which is now at the bottom of the dialyser, from the dialyser.).
Rev. B
Rotate the dialyser so that the blue end of the dialyser is up.
Deselecting EMPTYING allows the EMPTYING process to be interrupted.
After a short time, when the dialysate side of the dialyser is empty, an operator
message will appear on the Touch Screen and the EMPTYING Action key
disappears. The red dialysate connector can be disconnected from the dialyser and
reattached to its bypass port on the machine.
Press the FINAL RINSE Action key to initiate this process.
WARNING
In the case of bicarbonate dialysis, the Acid/Acetate concentrate connector must
be left on the machine so that the DESCALING procedure can be performed.
WARNING
At the end of WASHBACK, if the user does not activate the AutoEmptying
procedure, the blue dialysate connector can be reattached to its bypass port on the
machine so that the dialysate side is emptied through the hydraulic circuit
(standard EMPTYING).
Rev. B
5.10.3 Removing the BiCart

See Fig 5.4
Open the upper arm of the BiCart Holder by pulling the arm forward slightly and
tipping it up.
Cover the hole on the top of the BiCart (see Fig 5.4, 1).
Pull out the top of the BiCart while leaving the base in place (Fig 5.4, 2).
Disconnect the BiCart and immediately cap the lower end.
Place the holder arms in their original position (see Fig 5.4, 3):
a. Close the upper arm by tipping it down;
b. Close the lower arm by pulling the arm forward slightly and tipping it up.
Dispose of the empty BiCart per your facilitys practice.
1 2 3
Fig 5.4 Removal of the BiCart
Rev. B
5.10.4 End of Treatment

When the EMPTYING mode has been completed, the following view is displayed:
12:30 EMPTYING
TOTAL FLUID REMOVED TOTAL BLOOD
HEPARIN TOTAL DESCALING TIME

STOP RINSE
VEN ART
BLOOD FLOW FINAL RINSE TIME
VINEGAR DESCAL
BLOOD FLOW
DESCALING
BPM REPORT KT/V MACHINE

FINAL RINSE
Note
The VINEGAR DESCAL and DESCALING Action keys appear only when a Bicarbonate
dialysis was performed; a FINAL RINSE is performed automatically following a
DESCALING procedure.
Note
The FINAL RINSE Action key appears only when an Acetate dialysis was performed.
The DESCALING Action Key appears if the VINEGAR DESCAL parameter in Config is
set to NO or to YES, and if a Bicarbonate dialysis treatment has been performed. If the
VINEGAR DESCAL parameter is set to YES or to ALWAYS, the VINEGAR DESCAL
Action key is available. In the case of VINEGAR DESCAL, the operator must check
that the acid/acetate line is connected to the vinegar container.
During the DESCALING process (selection of the VINEGAR DESCAL or the

DESCALING Action keys), the DESCALING TIME value will decrease, indicating the
time remaining in the DESCALING process. The following message also appears:
Wait, Descaling in progress
and a progress bar is displayed indicating that DESCALING is occurring.
Rev. B
After the DESCALING or VINEGAR DESCAL Action keys have been pressed they will
not be available again until the end of the next dialysis treatment.
FINAL RINSE will begin automatically following a DESCALING procedure.

If an ACETATE dialysis has been performed the FINAL RINSE Action Key appears
immediately after EMPTYING has been completed. Pressing the FINAL RINSE Action
Key initiates the Final Rinse process.
During the FINAL RINSE process:

The FINAL RINSE TIME value decreases, indicating the time remaining in the Final
Rinse process;
The DESCALING TIME value is no longer displayed;
the FINAL RINSE Action key disappears and will not be available until after the
next dialysis treatment.
The STOP RINSE Action key allows a quick access to the next dialysis treatment
skipping partially or completely the DESCALING process and/or the FINAL RINSE
process. Refer to 5.10.5 Quick Access to the Next Dialysis Treatment, in this
section, for a detailed description of this procedure.
Before starting a new dialysis treatment remove the used Cartridge Blood Set and
dialyser.
WARNING
Follow facility procedures for proper disposal of used Cartridge Blood Set, dialysers,
and other disposables per local regulations.
Note
When FINAL RINSE is completed, the machine returns in Idle phase and performs the T1
Tests. Before selecting a new process, wait at least 1 minute to complete the T1 Tests.
Rev. B
5.10.5 Quick Access to the Next Dialysis Treatment

When the EMPTYING mode has been completed, the STOP RINSE Action key
becomes available and remains available for all the DESCALING process and FINAL
RINSE process. It allows the machine to skip partially or completely the DESCALING
process and/or the FINAL RINSE process and to return in Idle phase for the next
dialysis treatment.
After the STOP RINSE Action key is pressed, the following superimposed window will
appear:
CONFIRMATION LAST ACTION MADE
ENTER To Confirm
WARNING: Remove the Cartridge Blood Set
and install a new one.
By pressing the CONFIRM button, the machine will return in Idle phase and, after T1
tests completion, it is ready for the next dialysis treatment.
WARNING
Before starting a new dialysis treatment, ensure that the used Cartridge Blood Set
and dialyser have been removed and a new Cartridge Blood Set and dialyser have
been installed.
WARNING
If, after a bicarbonate dialysis, the DESCALING process is partially or completely
skipped by pressing the STOP RINSE Action key, it is strongly recommended to
follow the Precipitate Control (ADR) recommendations provided in Section 06
CLEAN/DISINFECT, in this manual.
Rev. B
SECTION 5.A - SPECIAL PROCEDURES 5.A-1
5.A SPECIAL PROCEDURES

5.A SECTION 5.A - SPECIAL PROCEDURES
5.A.1 Emergency procedures for Power Failure

In the event of a power failure:
An audible alarm is sounded for at least 2 minutes.
A visual alarm is given with a flashing yellow light.
The duration of the power failure is monitored.
Proceed as follows:
Clamp the venous line under the Venous Line Clamp.
Carefully remove the venous line from the Venous Line Clamp by depressing the
button on the Venous Line Clamp and pulling the venous line to the left..
WARNING
Failure to remove the venous line from the Venous Line Clamp can result in
rupture of blood lines or dialyser when hand cranking the Blood Pump.
Remove the arterial line from the Arterial Clamp (if Single Needle is available on
the machine).
Remove the Blood Pump Crank from its holder on the rear of the machine and
place it in the operating position in the Blood Pump Rotor.
Unclamp the venous line and with the crank manually turn the Blood Pump Rotor
counter-clockwise at a flow rate high enough to prevent stagnation or clotting of
the blood.
WARNING
During a power failure, all safety systems of the machine are disabled or are not
operational.
It is particularly important to check that all four clamps in the 4 Position Line
Clamp, above the Blood Pump, are closed in this situation.
Once the power supply has been restored, the Protection System starts the procedure
to reset the proper conditions.
The machine reverts to one of two specific Safe States depending on the duration of
the power failure:
Short Power Failure : less than 20 seconds

Long Power Failure : more than 20 seconds and less than 4 minutes
WARNING
Rev. B
5.A-2 PHOENIX OPERATOR MANUAL
Proceed as follows:
Remove the Blood Pump Crank from the Blood Pump Rotor.
Return the Blood Pump Crank to its holder on the rear of the machine.
Clear the specific Safe State by pressing the OVERRIDE button. The Blood Pump
will start at the pre-programmed speed.
Note
In the case of a Short Power Failure, if the operator does not press the OVERRIDE button
within 30 seconds, the specific Safe State is automatically cleared.
Reinsert the venous line into the Venous Line Clamp.

If in Single Needle mode, reinsert the arterial line into the Arterial Line Clamp.
Return the clamps on the 4 Position Line Clamp to the appropriate positions for
dialysis.
Note
If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic pathway
for more than 30 minutes, it is recommended that an acetic acid rinse should be
performed when the machine is switched back ON.
Rev. B
5.A.2 Emergency procedures for power failure with the

BATTERY BACKUP feature
WARNING
This emergency procedure for Power Failure is applicable only if your Phoenix
machine is equipped with the Battery Backup Kit.
Refer to local representative to verify if your machine is already equipped with the
BATTERY BACKUP Kit.
A BATTERY BACKUP feature is available on Phoenix machine so that, in case of a

power failure, the blood module and all the safety systems will remain enabled and
operational for approximately 15 minutes. The machine will continue to operate,
allowing the operator to rinseback the blood and disconnect the patient. The
interruption of the AC supply voltage is signaled by the NO POWER #353 alarm.
This alarm remains on the Touchscreen for the duration of the power failure.
Note
If the interruption of the AC supply voltage occurs when the machine is in IDLE mode, no
alarm will be activated.
Note
During power failure the heater is turned off.
In case of a power failure, depending on the machine operating conditions, proceed

as follows:
In Rinsing or Disinfection: Switch OFF the machine.

In Dialysis, during the Dialysate Preparation phase up until the Patient Connection:
Switch OFF the machine.
In Dialysis, during the Treatment phase: perform a Rinseback to return the blood
and disconnect the patient. Then Switch OFF the machine.
In Emptying or Descaling: Switch OFF the machine.
A message is also displayed in the Operator Message area suggesting the proper
action to be performed during each specific machine operating condition.
Note
If the power failure lasts for less than 3 minutes, once the AC Power Supply returns:
The NO POWER #353 alarm disappears;
The interrupted process automatically restarts and no operator intervention is required.
Rev. B
Note
In Rinsing or Disinfection, if the NO POWER #353 alarm is displayed for more than 3
minutes, the machine will be automatically Switched OFF. A continous audible signal,
decreasing in tone, sounds for approximately 5 seconds once the machine is switched
OFF.
Note
If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic
pathway for more than 30 minutes, it is recommended that an acetic acid rinse should be
performed when the machine is switched back ON.
Note
The Battery, when fully charged, is able to maintain the machine operational during a
power failure for approximately 15 minutes before it discharges.
Each time a power failure occurs, the Battery loses a quantity of its power and it has to
be recharged by leaving the machine switched ON.
After a power failure lasting 15 minutes, the time necessary to fully recharge the Battery
is 10 hours.
Note
When the machine remains switched OFF, the Battery gradually loses its charge.
After a long storage (at ambient temperature), before using again the machine, it is
recommended to keep it switched ON for a minimum time of 2 hours for each month it
has been left switched OFF.
If the storage temperature is greater than 25C, the time necessary to recharge the
Battery doubles.
If the BATTERY BACKUP is discharged or becomes discharged during a power failure,

a >GENERAL SAFE STATE< alarm is generated and the BATTERY BACKUP feature is
no longer active.
Proceed as follows:
Record DIALYSIS TIME, WEIGHT LOSS/H, TOTAL FLUID REMOVED, TOT
WEIGHT L, and TOTAL BLOOD, and other treatment data, if possible.
Ensure that all four clamps in the 4 Position Line Clamp, above the Blood Pump,
are closed.
Carefully remove the venous line from the Venous Line Clamp by depressing the
button on the Venous Line Clamp and pulling the venous line to the left.
WARNING
Rev. B
Remove the arterial line from the Arterial Clamp (if Single Needle is available on
the machine).
Remove the Blood Pump Crank from its holder on the rear of the machine and
place it in the operating position in the Blood Pump Rotor.
Unclamp the venous line and with the crank manually turn the Blood Pump Rotor
counter-clockwise at a flow rate high enough to prevent stagnation or clotting of
the blood.
WARNING
Once the power supply has been restored:
Proceed as follows:
Switch ON the machine.
Reinsert the venous line into the Venous Line Clamp.
If in Single Needle mode, reinsert the arterial line into the Arterial Line Clamp.
Return the clamps on the 4 Position Line Clamp to the appropriate positions for
dialysis.
Perform the Fast Recovery procedure (See Fast Recovery of the Dialysis process,
in this Section).
Rev. B
5.A.3 Fast Recovery of the Dialysis process

During the course of a dialysis treatment certain conditions may cause the machine to
halt:
As a consequence of an alarm condition a General Safe State is generated (see
Section 8 - Alarms and Signals).
A problem with the Power Supply reduces the voltage to the machines
electronics.
In both cases it is impossible to continue the dialysis treatment and the machine must
be turned OFF.
If the machine halt was caused by a temporary malfunction or by unexpected

operations, turning the machine OFF and then back ON may clear the incorrect
condition.
WARNING
The use of a Fast Recovery of the Dialysis process procedure must be limited to
exceptional cases where the normal recovery procedure can not be performed in
accordance with the standard use of the machine, but where the current dialysis
treatment must be continued.
WARNING
After pressing the SETUP Action key, DO NOT select a dialysate type
(ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine
and the Red and Blue Dialysate Connectors are connected to the dialyser.
The Fast Recovery of the Dialysis process may, therefore, be attempted without
manually disconnecting the patient. This procedure returns the machine to the
PATIENT CONNECT mode, so that the Blood Pump is active within a few seconds
after the machine is turn ON.
WARNING
The Fast Recovery of an interrupted dialysis treatment can only be performed if
TREATMENT has already started (i.e. after PATIENT CONNECT) and has been
interrupted before the EMPTYING mode. This procedure can be performed if the
Patient Sensor has detected blood in the venous blood line and no service
processes (ADR or calibration) have been performed before restarting the dialysis
treatment.
Note
The possibility to restart DIALYSIS using the Fast Recovery of the Dialysis process
procedure is allowed if, and only if:
The previous treatment was interrupted after the PATIENT CONNECT mode and
before the EMPTYING mode.
At subsequent Power ON, the Patient Sensor has detected blood (the icon is
highlighted on the icon bar).
No service processes (rinsing or disinfection or calibration) were performed before
restarting the dialysis treatment.
Rev. B
To perform the Fast Recovery of the Dialysis process procedure:
WARNING
Do not remove the Blood Pump Segment from the Blood Pump.
Do not remove the venous line from the Air Bubble Detector/Patient Sensor.
1. Record DIALYSIS TIME, WEIGHT LOSS/H, TOTAL FLUID REMOVED, TOT

WEIGHT L, and TOTAL BLOOD, and other treatment data, if possible.
2. Turn the machine OFF.
3. Clamp the venous line below the ABD and then turn the machine ON.
4. Wait for the software to load.
WARNING
If the operator erroneously selects a procedure other than SETUP, the Fast
Recovery of the Dialysis process procedure cannot be performed and the patient
must be disconnected.
5. Press the SETUP Action key.

6. The operation to be performed for a Fast Recovery of the Dialysis process is
indicated in the Operator Message Window:
Press + and hold, press - and hold, release +

then release - to restart interrupted treatment
Select these buttons on the Main Control Panel. The machine will immediately go
to the PATIENT CONNECT mode.
7. Unclamp the venous line.
8. Press the Blood Pump ON/OFF button to start the Blood Pump.
Note
During the time between the machine switching OFF and the next Blood Pump activation,
it is possible to manually turn the Blood Pump Rotor counter-clockwise at a flow rate high
enough to prevent stagnation or clotting of the blood, by using the Blood Pump Crank.
Before manually turning the Blood Pump Rotor:
remove the venous line from the Venous Line Clamp by depressing the button on the
Venous Line Clamp and pulling the venous line to the left;
remove the clamp from the venous line below the ABD;
ensure that all four clamps in the 4 Position Line Clamp, above the Blood Pump, are
closed.
Once the SETUP Action Key appears, reinsert the venous line in the Venous Line Clamp.
To restart the interrupted treatment, after the selection of the Blood Pump ON/OFF
button to start the Blood Pump, return the clamps on the 4 Position Line Clamp to the
appropriate positions for dialysis.
WARNING
During the time between the machine switching OFF and the next restart of the
interrupted treatment by the +/- buttons selection, all safety systems of the machine
are disabled or are not operational.
9. Reset the TOT WEIGHT L, DIALYSIS TIME and the WEIGHT LOSS/H using the
SET mode. Activate Heparin and BPM, if prescribed. If the CentryNet option was
activated before the machine halt, refer to Section 07 Communication System,
for a detailed description of the CentryNet option re-activation or deactivation
procedure after a Fast Recovery of the Dialysis process.
Rev. B
Note
After a Fast Recovery of the Dialysis process, both the UF Profile curve type and the
Conductivity Profile curve type are set automatically to CONSTANT. During the current
dialysis treatment it is no longer possible to re-activate UF and Conductivity Profiling.
10. Select the DIALYSIS Action key on the PATIENT CONNECT view.
If a ! Blood Leakage #28 alarm occurs, press the OVERRIDE button.
WARNING
Note that any treatment parameters that were set for the dialysis treatment are
transient, i.e. they are lost when a Fast Recovery of the Dialysis process procedure
is performed.
Therefore, following a Fast Recovery of dialysis, the only treatment parameters that
are retained are:
for RX dialysis the default data values stored in Rx Config
for Standard dialysis the default data values stored in Config
The only exception are:

for RX dialysis the machine retains the PAT CONN B FLOW parameter value
stored in CONFIG instead of the value stored in Rx Config
for Standard dialysis and RX dialysis the machine retains the DIALYSIS TYPE:
ACETATE/BIC CONC/BIC BICART, set for the current treatment instead of the
DIALYSIS TYPE stored in CONFIG/Rx Config.
NOTE: in case of Computer Prescription of the Treatment (see Section 7 -

Communication System) the restored treatment parameters are:
Dialysis Mode: the last one selected

Dialysis Type: the last one performed by the machine
WARNING
If during the course of the restarted DIALYSIS, the same problem reoccurs, the
cause is not a temporary malfunction.
The machine must be turned OFF and the patient manually disconnected.
Call for Service.
Note
Once the patient has been manually disconnected and the following dialysis may be
started normally, do not perform the Fast Recovery of the Dialysis process procedure:
disconnect manually and the machine OFF.
At subsequent power ON, do not select a Fast Recovery of the Dialysis process with the
+/ - keys. An ADR process must be selected to remove the data related to the Fast
Recovery of the Dialysis process from the machines memory.
Then, select the type of dialysis required (SETUP and proceed as usual with the
preparation of the machine.
Rev. B
5.A.4 Sampling of water from the machine

If local regulations or the facilitys procedures requires to test the chemical-physical
characteristics of water flushing in the hydraulic circuit of the machine or in order to
culture the water to be used for dialysis, for microbiological monitoring, a sample of
water may be obtained from the machine during SETUP, prior to dialysate
concentrate connection.
To obtain a sample:
Press the SETUP Action key to start dialysate preparation.

Remove the Blue Dialysate Connector from the machine and hold it over a
collection receptacle. This action could generate a flow error evidenced by an
alarm and a RESTART condition on the Touch Screen.
While the flow from the Blue Dialysate Connector has stopped because of the
RESTART condition, prepare the Dialysate Line Connector, per your facilitys
protocol.
Press the RESTART button on the Touch Screen to restart dialysate flow from the
Blue Dialysate Line. Continue pressing the RESTART button on the Touch Screen
to continue flow from the Blue Dialysate Connector until an appropriate time or
flow (as defined by the facilitys protocol, but not less than 2 minutes) has been
reached. At this time a sample may be collected.
After the sample has been collected, reconnect the Blue Dialysate Connector to its
Blue Bypass port on the machine. Press the RESTART button on the Touch Screen
to restore the flow in the hydraulic circuit.
5.A.5 Sampling of Dialysate

A sample of dialysate may be taken to carry out laboratory tests.
WARNING
verified by clinical laboratory results, for each dialysate concentrate used for
dialysis treatment.
PERFORMING DIALYSATE SAMPLING
Samples for conductivity testing may be obtained at the following times:
a. Prior to initiation of treatment, after the appearance of the operator message End
Of Dialysate Prep, You Can Proceed, and before starting to prime the dialysate
side of the dialyser.
b. During DIALYSIS.
Note
When a dialysate sample is obtained during DIALYSIS using the Sampling Device, the alarm
message A Connector Position#2 will appear on the Touch Screen.
Rev. B
HOW TO OBTAIN THE DIALYSATE SAMPLE
Dialysate sample through the Blue Dialysate Connector

Follow this procedure prior to initiation of treatment, only if Priming after Dialysate
Preparation is complete is performed (DIAL AUTO PRIME parameter set to NO):
After appearance of the operator message indicating that Dialysate Preparation is

Complete, connect the Red Dialysate Connector to the dialysers red (outlet)
dialysate port, leaving the Blue Dialysate Connector unattached.
Hold the Blue Dialysate Connector over a sample collection container.
Press the BYPASS Action key to start the flow of dialysate into the sample
collection container.
Collect the dialysate sample then press the BYPASS Action key to stop the
dialysate flow.
Connect the Blue Dialysate Connector to the dialysers blue (inlet) dialysate port.
Press the BYPASS Action key to resume flow of dialysate through the dialyser.
Dialysate sample through the Sampling Device

Follow this procedure:
either prior to initiation of treatment, if Priming during Dialysate Preparation is
performed (DIAL AUTO PRIME parameter set to YES)
or during TREATMENT.
To obtain the dialysate sample proceed as folows:

Insert the Sampling Device in the Rinse Port corresponding to the Acid/Acetate
Connector (or the Blue Bicarbonate connector for bicarbonate sampling).
Obtain the sample.
In both the procedures, prior to obtaining a sample, it is recommended to:
Discard the fluid flowing from the Acid/Acetate Rinse Port during the first minute
of sampling.
Discard the fluid flowing from the Bicarbonate Rinse Port in the first 2 minutes of
sampling.
Obtain the dialysate sample when the conductivity is stable.
Note
For reliable sampling, it is important not to change the conductivity of the machine during
sampling.
Rev. B
OBTAINING A BICARBONATE SAMPLE WITH BICART DIALYSIS

Open the upper arm of the BiCart Holder. (See Fig..1 (A) )
Disconnect the Blue Bicarbonate (blue) Concentrate Connector (See Fig.1 (C) )
from its Rinse Port.
Insert the sampling device in the Blue Rinse Port corresponding to the Bicarbonate
Connector for bicarbonate sampling.
Obtain the sample.
Fig. 1
Rev. B
5.A.6 Temporary Disconnection of the Patient : PAUSE

THERAPY Procedure
Note
This feature is available only if the PAUSE THERAPY parameter is set to YES in the
CONFIG menu.
If configured, the PAUSE THERAPY Action key is present in the CHANGES view when
accessed during the TREATMENT mode.
Note
During the PAUSE THERAPY procedure, appropriate operators messages will direct the
user to the required steps in order to correctly perform the procedure.
In order to temporarily disconnect the patient during TREATMENT:
1. If performing a Single Needle dialysis, select the CHANGES Action key, then the
CHANGE TO DN Action key on the CHANGES view.
2. Select the PAUSE THERAPY Action key on the CHANGES view.
3. This selection must be confirmed using the CONFIRM button on the Main Control
Panel.
4. The Blood Pump stops automatically.
5. Clamp the arterial and venous lines and the patients access sites.
6. Connect the arterial and the venous line together using a sterile priming connector
or recirculation device.
7. Unclamp the Cartridge Saline Access Line and the Saline Administration Line.
8. Unclamp the arterial and venous lines.
9. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control
Panel to recirculate the blood in the extracorporeal circuit, per your facilitys
protocol.
When the patient returns :
1. Turn the Blood Pump OFF using the ON/OFF button on the Blood Pump Control
Panel.
2. Clamp the Cartridge Saline Access Line and the Saline Administration Line.
3. Clamp the arterial and venous lines. Disconnect the blood lines by removing the
sterile priming connector or recirculation device.
4. Reconnect the arterial and venous lines to the patients access sites.
5. Unclamp the arterial and venous lines and the patients access sites.
6. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control
Panel.
7. Press the PAUSE THERAPY Action key to deselect PAUSE THERAPY.
8. Press the CLOSE Action key on the CHANGES view, the standard treatment view
will be displayed.
Note
The PAUSE THERAPY Action key is highlighted while the procedure is activated.
Rev. B
Note
During the PAUSE THERAPY procedure the alarm W! STILL IN PAUSE THERAPY is
displayed to advise the operator that the machine is in a temporary status.
Note
The CLOSE and FILTER CHANGE Action keys in the CHANGES view disappear while the
PAUSE THERAPY procedure is activated.
Note
During the PAUSE THERAPY procedure:
the updating of DIALYSIS TIME, TOTAL FLUID REMOVED and TOTAL BLOOD
parameters are interrupted
the WEIGHT LOSS/H is stopped;
the Heparin program is stopped;
Profiling is stopped.
When the treatment is restarted, the updating of the parameters is automatically
reactivated, and the WEIGHT LOSS/H, Profiling and the Heparin program are resumed. It
is not necessary to set the TOT WEIGHT L parameter again.
Note
During the PAUSE THERAPY procedure, the limits of the Venous Pressure Alarm Window
and Arterial Pressure Alarm Window are set to the wider range. This value is maintained
throughout the PAUSE THERAPY procedure.
Rev. B
5.A.7 BiCart Change

When the PAUSE BICART Action key is selected, the BiCart may be replaced, once
dialyser PRIME is completed and all the preparations and settings have been
completed.
BICART CHANGE procedure

Press the CHANGES Action key.
The following view appears:
12:30 CHANGES
CHANGE TO SN
CHANGE TO DN
PAUSE THERAPY
(See Note 1 below)
VEN ART
PAUSE BICART
BLOOD FLOW
BICART PRIM.
TOTAL BLOOD CONDUCTIVITY CHANGE TO
LIQ BIC
BLOOD FLOW
CHANGE ACID
CLOSE
Note 1
Depending on the machine operating phase the FILTER CHANGE Action key or the
PAUSE THERAPY Action key is displayed.
Note
The BICART PRIM. Action key is available only after the PAUSE BICART Action key has
been pressed.
Press the PAUSE BICART Action key to momentarily stop flow through the BiCart.
This helps avoid splashing liquid when the BiCart is removed.
Rev. B
After the PAUSE BICART Action key has been pressed, the following message will
appear:
Remove the BICART and insert a new one.

Press BICART PRIME to start the procedure.
Warning: Pressing BICART PRIME again
will stop BICART priming procedure.
Replace the BiCart and then press the BICART PRIM. Action key to start the
priming procedure (advice on how to perform the operation will appear in the
Operator Messages Area).
The following message will appear in the Operator Messages Area with a warning
saying that if the BICART PRIM. Action key is pressed again, priming will be
stopped:
Wait : BICART Priming in Progress...

Warning : if You Push BICART PRIM. Again
the BICART Procedure will be Stopped.
Note
If the operator stops the priming procedure by pressing the BICART PRIM. Action key, the
following message is displayed:
Bicart priming interrupted,
Press BICART PRIME to complete procedure.
Priming can be considered finished when the above operator message disappears.
Rev. B
5.A.8 Switching from BiCart Dialysate to the use of Liquid

8.4% Bicarbonate Dialysate
If the operator wants to change from BiCart dialysate to liquid bicarbonate dialysate,
the CHANGE TO LIQ BIC Action key allows continuing the dialysis treatment using
liquid 8.4% bicarbonate from external concentrate containers or delivered from the
Central Concentrate Supply system.
Note
After switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate,
both in external containers and from the Central Concentrate Supply system, it is not
possible to return to using BiCart dialysate in the current dialysis treatment.
CHANGE TO LIQ BIC procedure
12:30
CHANGE TO SN
CHANGE TO DN
PAUSE THERAPY
(See Note 1 below)
VEN ART
PAUSE BICART
BLOOD FLOW
BICART PRIM.

LIQ BIC
BLOOD FLOW
CHANGE ACID
CLOSE
Note 1
Depending on the machine operating phase, either the DIALYSER PRIME Action key or
the PAUSE THERAPY Action key is displayed.
Rev. B
Note
The CHANGE TO LIQ BIC Action key is available only if the BIC LIQUID DIAL USE
parameter is set to YES in Config/Centre Conf/Functions view.
Press the CHANGE TO LIQ BIC Action key.
The following superimposed window will appear:

Confirm the Change from BiCart to Liquid Bic.
Press CONFIRM to Proceed
Remove Bicart. Connect blue connector to
the correct position for the new bicarb source
Warning: To avoid compromizing Pt Safety
Ensure the proper Bic. Conductivity set
Press the CONFIRM button to allow the machine to proceed in BICARB CONC
dialysis mode.
Remove the BiCart and close the BiCart arms. That will clear the Bicart
Connector Position #22 Alarm.
If switching to the use of Liquid Bicarbonate 8.4% in an external container:

disconnect the blue concentrate connector on the lower front panel of the
machine and connect it to the blue concentrate wand and then place the wand
into the bicarbonate concentrate container. That will clear the B Connector
Position #18 Alarm.
If switching to the Central Concentrate Supply system: disconnect the blue

concentrate connector on the lower front panel of the machine and connect it to
the blue connector dedicated to bicarbonate concentrate delivery from the
Central Concentrate Supply system. That will clear the B Connector Position
#18 Alarm. Refer to section 03 Central Concentrate Supply, in this manual, for a
detailed description of connector positioning in Bicarbonate dialysis.
Press the Set button to enter in Set mode. Check and if necessary adjust the BIC
8.4% COND value set.
Press the CLOSE Action key to exit from the CHANGES view.
WARNING
If switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate
concentrate, both in external containers and delivered from the Central
Concentrate Supply system, it is the operators responsibility to verify that proper
8.4% bicarbonate concentrate is being used.
WARNING
If a switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate
concentrate in external containers, if the machine has not been correctly calibrated
for the liquid Concentrate used, the ! Concentrate Cans #40 Alarm can occur.
After carefully verifying that the correct concentrates are being used, and that the
dialysate Conductivity is correct, the operator may clear the alarm by performing
the PB Autocalibration Procedure (see 5.A.11 Procedure for Autocalibration of
the Peristaltic Pumps during DIALYSIS, in this section, for complete instructions.)
Rev. B
5.A.9 Acid/Acetate Concentrate Supply Change

If the operator needs to change acid/acetate concentrate containers, or to change
from containers to acid delivered from the Central Concentrate Supply system, or to
change from the Central Concentrate Supply system to an acid/acetate container, the
CHANGE ACID Action key is used.
CHANGE ACID procedure
12:30
CHANGE TO SN
CHANGE TO DN
PAUSE THERAPY
(See Note 1 below)
VEN ART
PAUSE BICART
BLOOD FLOW
BICART PRIM.

LIQ BIC
BLOOD FLOW
CHANGE ACID
CLOSE
Note 1
Depending on the machine operating phase, either the FILTER CHANGE Action key or
the PAUSE THERAPY Action key is displayed.
Rev. B
Press the CHANGE ACID Action key.
The following superimposed window will appear:
Change the Acid supply and

press CONFIRM to Proceed
then press OVERRIDE to resume treatment
Warning: To avoid compromizing Pt Safety
Ensure the proper CONDUCTIVITY set
Press the CONFIRM button to proceed with the procedure.
If the Ace Can is Empty #1 Alarm is present, press the OVERRIDE button to clear
the alarm.
When changing the acid/acetate concentrate external container: disconnect the

white concentrate connector connected to the white concentrate wand and
connect it to the white concentrate wand placed in the new acid/acetate
concentrate container. If the Ace Can is Empty #1 Alarm is present, press
OVERRIDE to clear the alarm and to start uptake of acid/acetate from the new
container.
When switching to the Central Concentrate Supply system: disconnect the white
concentrate connector connected to the white concentrate wand and connect it
to the RED connector dedicated to acid concentrate delivery from the Central
Concentrate Supply system. Refer to section 03 Central Concentrate Supply, in
this manual, for a detailed description of connectors positioning in Bicarbonate or
BiCart dialysis. f the Ace Can is Empty #1 Alarm is present, press OVERRIDE to
clear the alarm and to start uptake of acid from the Central Concentrate Supply
system.
When switching from Central Concentrate Supply to the use of acid/acetate

concentrate in external container: disconnect the white concentrate connector
connected to the RED connector dedicated to acid concentrate delivery from the
Central Concentrate Supply system and connect it to the white concentrate wand
placed in the acid concentrate container. If the Ace Can is Empty #1 Alarm is
present, press OVERRIDE to clear the alarm and to start uptake of acid from the
concentrate container.
Press the Set button to enter in Set mode. Check and if necessary adjust the
CONDUCTIVITY value.
Press the CLOSE Action key to exit from the CHANGES view.
Rev. B
Note
If the acid/acetate concentrate supply change procedure has been performed without the
occurrence of Ace Can is Empty #1 Alarm, it may appear after completion of the
procedure. Press the OVERRIDE button to clear the alarm and to start uptake of
acid/acetate.
WARNING
Both with Acid/Acetate concentrate container change and with switch from the use
of acid in external containers to the use of acid concentratet delivered from the
Central Concentrate Supply system, it is the operators responsibility to verify that
proper acid/acetate concentrate is being used.
WARNING
Both with an Acid/Acetate concentrate formula change and with a switch from
Central Concentrate Supply system to the use of acid in external containers, if the
machine has not been correctly calibrated for the acid/acetate Concentrate used,
the ! Concentrate Cans #40 Alarm can occur. After carefully verifying that the
correct concentrates are being used, and that the dialysate Conductivity is correct,
the operator may clear the alarm by performing the PA Autocalibration Procedure
(see 5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during
DIALYSIS, in this section, for complete instructions.)
Rev. B
5.A.10 Dialyser Replacement
Dialyser can be replaced both during the Patient Connection phase and during the
dialysis treatment.
To replace the dialyser proceed as follows:
During the Patient Connection phase:

Stop the Blood Pump and follow facilitys procedures to restitute blood and
disconnect the patient.
During a dialysis treatment:
Press the WASHBACK Action key on the DIALYSIS view and CONFIRM to
perform WASHBACK.
Perform WASHBACK.
When the patient has been disconnected:

Press the FILTER CHANGE Action key.
The following message will appear:
PROTECTION SYSTEM
Do You Confirm Filter Changing ?
Press ENTER To Confirm.
WARNING
The CONFIRM button, for Dialyser Change, must be pressed only after having
completed the WASHBACK mode.
Press CONFIRM; the following message will appear:
Do not remove the Cartridge now

Place the dialysate hoses on their rinse ports.
Disconnect the dialysate connectors from the dialysate ports of the dialyser and
reattach them to their bypass ports on the machine.
Note
Starting from the above Operators message appearance, the dialyser may be replaced.
Wait until the following message is displayed in the Operator Messages Area:
Replace the cartridge and dialyser.

After the venous clamp opens, select the
desired priming procedure.
Rev. B
Replace the dialyser (if not yet done).

After the Venous Clamp opens, replace the Cartridge Blood set.
After confirming the DIALYSER CHANGE message, the dialyser re-priming view
will appear and the priming procedure must be repeated, according to the type of
dialyser being used. During the priming procedure the message Wait, Priming in
progress will appear on the Operator Messages Area.
When the priming procedure is complete, the PAT CONNECT Action key
becomes available.
Press the PAT CONNECT Action key and reconnect the patient to the
extracorporeal circuit.
After patient connection, press the TREATMENT Action key to restart the
interrupted treatment.
The treatment will automatically restart with the previous TOT WEIGHT L and
DIALYSIS TIME, TOTAL FLUID REMOVED and TOTAL BLOOD values retained.
Note
During the PAUSE THERAPY and the FILTER CHANGE modes, the updating of DIALYSIS
TIME, TOTAL FLUID REMOVED and TOTAL BLOOD are suspended. At the restart of
DIALYSIS, the updating of these parameters is automatically reactivated without having to
set the TOT WEIGHT L again.
Note
If Conductivity Profiling and/or UF Profiling were selected, during the WASHBACK mode,
the profiling is stopped. When the treatment is resumed the profiling will restart from the
last executed values.
Rev. B
5.A.11 Procedure for Autocalibration of the Peristaltic

Pumps during DIALYSIS
During DIALYSIS, if a ! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS
#40 alarm occurs, an autocalibration of the Peristaltic Pump Inserts may be
performed.
The autocalibration procedure during DIALYSIS is slightly different from the calibration
procedure performed by Service personnel.
To prepare the machine for an Autocalibration procedure:

Deactivate Profiling and/or Diascan, in order to have a stable conductivity.
Press the Machine Navigation key.
Select the PA AUTOCALIB or PB AUTOCALIB Action key corresponding to the
pump that requires autocalibration.
Verify that the appropriate concentrate is attached. Press the appropriate
AUTOCAL Action key. A request to CONFIRM this action will be displayed on a
superimposed window on the Touch Screen.
WARNING
In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration, the user
must always verify that the correct concentrates are connected to the machines
The use of incorrect concentrates may result in an a incorrect dialysate
conductivity, that may not be detectable by the Protection System.
The selected Action keys will remain highlighted and the Autocalibration pictogram is
displayed until the start of the Autocalibration process. During Autocalibration, the
Action key will disappear but the pictogram will remain on the Pictogram area.
Note
The only Action keys that will be displayed are those that are appropriate for the type of
dialysate concentrate that is being used, as indicated in this table:
Acid/Acetate Bic 6.6 Bic 8.4 Bicart

% %
PA YES YES YES YES
PB NO YES YES NO
If the Autocalibration Procedure fails, the W! .. AUTOCALIBRATION FAILED alarm

message will appear.
Rev. B
Note
The indication of the relevant pump (PA or PB) appears in the alarm message.
If the Autocalibration Procedure fails, the pump speed calibration values are not
saved, the pump autocalibration is not completed and the ! CONCENTRATE CANS:
A PUMP or B Pump or A+B PUMPS #40 alarm may reoccur.
Note
The Peristaltic Pump Autocalibration Procedure is an emergency operation intended
only to enable completion of the current DIALYSIS treatment. It is recommended to
perform the Standard Autocalibration Procedure (see Procedure for Standard
Autocalibration of the PA, PB, or PUF Pumps during the Dialysate Preparation Process
in this section) during SETUP of the machine for the next dialysis treatment.
WARNING
If the ! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS #40 alarm
occurs frequently, call for Service.
Rev. B
5.A.12 Procedure for Standard Autocalibration of the PA,

PB, or PUF Pumps during the Dialysate Preparation Process
To prepare the machine for Standard Autocalibration:
Turn the machine ON.
Press the SETUP Action key.
Select the type of dialysate required.
When these operations have been completed, the dialysate preparation will begin
and the Standard Pump Autocalibration may be performed.
To initiate the autocalibration process:
Press the Machine Navigation key.

Select the PA AUTOCALIB, or PB AUTOCALIB, or PUF AUTOCALIB Action key
relating to the pump for which autocalibration is required.
WARNING
The three Autocalibration Action keys are available only before Dialysate
Preparation is complete.
Press the appropriate Action key to activate the Autocalibration Procedure (it is
necessary to CONFIRM this action)
The selected Action key remains highlighted and the Autocalibration pictogram is
displayed until the start of the autocalibration process.
At initiation of Autocalibration, a superimposed window displays a request to

CONFIRM the appropriate concentrates are attached.
During Autocalibration, the Action key will disappear but the pictogram will remain
on the Pictogram area.
WARNING
In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration, the user
must always verify that the correct concentrates are connected to the machines
The use of incorrect concentrates may result in an a incorrect dialysate
conductivity, that may not be detectable by the Protection System.
Rev. B
Note
The only Action keys that will be displayed are those that are appropriate for the type of
dialysate concentrate that is being used, as indicated in this table:
Acid/Acetate Bic 6.6 Bic 8.4 Bicart

% %
PA YES YES YES YES
PB NO YES YES NO
PUF YES YES YES YES
Autocalibration is performed during the Dialysate Preparation process.
When the Autocalibration process is being performed, the following message is

displayed in the Operator Message Window:
Wait Autocalibration In Progress...
If the process is correctly completed, the machine proceeds with normal operation.
No further message appears. The Autocalibration pictogram will disappear from the
Pictogram area.
If the Autocalibration fails, one of the three following alarm messages appears:
If the process is incorrectly completed because the calculation has not been
carried out within the maximum time available:
Timeout on ... AutoCalibration
If the process is incorrectly completed because the calculation or the controls
provide negative results:
W! AutoCalibration Failed
If the process is incorrectly completed because an error has occurred during the
saving of the pump speed calibration values:
...AUTOCALIBRATION FAILED
Note
The indication of the relevant pump (PA, PB, or PUF) appears in the alarm message.
If the Autocalibration Procedure fails, the new pump speed calibration values are not
saved and the pump autocalibration is not correctly completed.
The machine then immediately performs the test relating to the relevant values, using
the previous pump speed calibration coefficients:
Acid/Acetate pump Final Conductivity Test

Bicarbonate pump Bicarbonate Conductivity Test
Ultrafiltration pump Ultrafiltration Test
Rev. B
If the Ultrafiltration Pump Test fails, a > GENERAL SAFE STATE < alarm occurs.
The machine must be turned OFF.
If the Acid/Acetate or Bicarbonate Pump Test fails, the machine proceeds after
confirmation.
If the Acid/Acetate or Bicarbonate Pump Test passes, the machine proceeds with
normal operation.
WARNING
If the Autocalibration Process fails, but the following Test passes, the machine
guarantees a degree of accuracy for the value subject to autocalibration.
It is recommended that the Autocalibration Procedure be repeated or the pump
insert replaced.
WARNING
The PA/PB Autocalibration Procedure is mandatory in each of the following cases:
Following a change of the pump insert.
Following a change in the type of concentrate being used.
Following a change from Central Concentrate Supply System to the use of
External Concentrate Containers.
Rev. B
5.A.13 Procedure for Automatic Autocalibration of the UF

Pump during the Dialysate Preparation Process
The Autocalibration of the UF Pump is automatically performed by the machine if it

detects that the pump insert characteristics require this operation.
In this case, during the Preparation Process the autocalibration pictogram is dispayed
while, in the Machine view, the PUF AUTOCALIB Action key becomes highlighted
and the following message appears in the Operator Message Window:
Wait Autocalibration In Progress...
In case of failure of this Autocalibration Procedure, it is recommended to call for

Service.
WARNING
Rev. B
5.A.14 Manual Disconnection of the Patient
During the course of a dialysis treatment certain conditions that make impossible to
continue the dialysis treatment may occurs (e.i., display backlight failure, keyboard is
not functioning). In these particular situations the manual disconnection of the patient
may be performed.
To manually disconnect the patient:

Remove the venous line from the Venous Line Clamp by depressing the push
button and pulling the venous line to the left.
WARNING
If Single Needle mode was chosen, remove the arterial line from the Arterial Line
Clamp.
Remove the Blood Pump Crank from the rear panel of the machine.
Insert the crank through the hole in the Blood Pump Cover and into the Blood
Pump Rotor.
Verify that the Cartridge Saline Line and Saline Administration Line are clamped.
Clamp the arterial line and the patients arterial access site.
Disconnect the arterial line from the patients arterial access site. Return the blood
in the patients access site to the patient according to the facilitys protocol.
Remove the Saline Administration Line and priming connector from the Cartridge
saline access line.
Attach the Saline Administration Line to the arterial line using the priming
connector from the Cartridge saline line.
Open the clamps on the arterial line and the saline administration line.
Open the clamps on the venous line and the patients venous access site.
When ready, turn the Blood Pump Crank counter clockwise to return blood to the
patient.
WARNING
The alarm system is inactive or impaired when power to the machine or Touch
Screen is off. While manually returning blood, watch the venous line for air. If air
is seen, immediately stop returning blood.
Rev. B
5.A.15 Diaphragm Neutral Position Procedure
Note
In certain conditions, one or both diaphragms of the Cartridge Blood Set may move out of
the neutral position. This causes pressure monitoring to become inaccurate and can result
in pressure alarms or T1 Test failures. (Neutral position is where the diaphragms fall
naturally when not exposed to pressure). The Diaphragm Neutral Position procedure
restores both diaphragms to their proper position. This procedure may be required to
remedy certain alarms; you may also perform it any time there is fluid/blood in the set and
you suspect pressure monitoring to be inaccurate. Part A of this procedure can be tried
first, but if the situation is not remedied, then Part B (a longer procedure) must be done.
WARNING
Before performing this procedure, ensure that the Cartridge drip chambers are no
more than half full of fluid. Failure to do this may result in patient blood loss.
Part A. Expose Diaphragms to Atmospheric Pressure

1. Make sure the Blood Pump is stopped and the Cartridge chambers are no more
than half full of fluid/blood.
2. Clamp the venous and arterial lines below the Cartridge; clamp all Cartridge access
lines in the 4-position Line Clamp.
3. Disconnect any caps, lines, or syringes connected to the Cartridge venous and
arterial access lines.
4. Open the Blood Pump Cover, being careful not to dislodge the pump segment.
5. Open the clamps on the venous and arterial access lines and remove the end
caps, if present. (This exposes the blood side of diaphragms to atmosphere)
6. Move the Cartridge slightly to unseat the diaphragms from the Red and Blue
Sealing Cones. (This exposes the air-only side of diaphragms to atmosphere)
7. Allow approximately 5 seconds for pressures to stabilize on both sides of the
diaphragms.
8. Align the diaphragms with the Sealing Cones; press lightly on the Cartridge to
reseat the diaphragms on the cones.
9. Close the Blood Pump Cover.
10. Close the venous and arterial access line clamps; replace end caps, or reconnect
previously attached lines/syringes.
11. Unclamp the venous and arterial lines. When ready, restart the Blood Pump.
Part B. Expose Diaphragms to Atmospheric Pressure/Clean Sealing Cones
Supplies Needed: 0.5% bleach solution and lint-free cloth
Note
To make a 0.5% bleach solution, mix 1 part 5.25% to 6% bleach with 9 parts water.
Rev. B
1. Perform Steps 1 through 5 of Part A of this procedure.

2. Replace the end caps of the venous and arterial access lines (or reconnect lines to
previously connected lines/syringes).
3. Remove all Cartridge access lines from the 4-position Line Clamp. Grasp the
Cartridge and pull the tab out of the slot. Tilt the Cartridge away from machine so
that the Red and Blue Sealing Cones are accessible.
4. Clean the Sealing Cones with a lint-free cloth and the 0.5% bleach solution.
Note
Debris on a Sealing Cone prevents an airtight seal between the machine and the
diaphragm and causes a diaphragm to lose its neutral position.
5. Replace the Cartridge in the slot, align the diaphragms with the Sealing Cones;
press the Cartridge toward machine to seat the diaphragms on the cones.
6. Reroute all Cartridge access lines into the 4-position Line Clamp. Clamp any
unused lines in the 4-position Line Clamp.
7. Close the Blood Pump Cover. Unclamp the venous and arterial lines.
8. When ready, restart the Blood Pump.
Rev. B
5.A.16 Manual Cleaning procedure for the Waste

Handling Option (WHO)
WARNING
WHO Drain Port before continuing with another patient treatment or once per day
if the WHO has been in use.
Note
Non-sterile components can be used to manually clean the WHO.
Open the WHO door by placing the thumb on the middle of the door and gently
lifting the WHO door tab.
Using a syringe with a priming connector as an adapter, inject 15 cc of undiluted
bleach (5.25%-6% sodium hypochlorite) into the WHO when the machine is in
IDLE phase.
WARNING
The patient must not be connected to the machine during this procedure.
WARNING
DO NOT USE this priming connector for patient related uses or any sterile
connections.
Remove the syringe and priming connector. Close the WHO door by placing the
thumb on the middle of the door and pushing.
Immediately begin SETUP for the next treatment or perform an ADR: RINSE
procedure to rinse the undiluted bleach from the WHO.
WARNING
DO NOT LEAVE undiluted bleach in the flow pathway of the machine.
WARNING
Following the WHO bleach procedure, before performing a Chemical Disinfection
using a chemical other than Bleach, allow the WHO to rinse at least 3 minutes in
the ADR Rinse cycle.
Rev. B
5.A.17 Transferring a primed Cartridge Blood Set to

another PHOENIX machine for continuation of treatment
WARNING
To transfer a primed Cartridge Blood Set to another PHOENIX for continuation of

treatment, the priming process may be skipped by temporarily changing the JUMP
PRIMING parameter to YES in the machines Config settings.
Step 1: Preparing the PHOENIX machine to which you will transfer the patient.
1. Turn the machine ON.
2. From the IDLE view, select Config/Centre Conf/Functions and change JUMP
PRIMING to YES. Press CONFIRM.
3. Press the kT/V Navigation key and press SET. Select the Diascan DIASCAN
parameter box and select NO. Press CONFIRM.
4. Return to the Home view, then start the preparation process by selecting the
SETUP Action key and then select the dialysate type to be used.
5. Place a new Cartridge Blood Set on the machine to allow the T1 test and
dialysate preparation to proceed. Do not prime this Cartridge Blood Set.
6. Wait for the PAT CONNECT Action key to appear. This machine is now ready to
receive the primed Cartridge Blood Set from the other machine.
Step 2: Removing the Cartridge Blood Set from the PHOENIX machine for
continuation of treatment on the PHOENIX machine previously prepared.
1. If possible, return the patients blood per the WASHBACK procedure. If unable to
return blood, make sure the blood pump is stopped, clamp the arterial and
venous lines, the arterial and venous dialyser lines, the Saline administration line
and the Heparin line (if a heparin syringe is present).
2. Close the 4 access lines on the top of the Cartridge Blood Set using the proper
end caps.
3. Open the clamps on the 4 Position Line Clamp, removing the Cartridge access
lines from the clamps.
4. Remove the venous line from the Venous Line Clamp and the arterial line from
the Arterial Line Clamp (if Single Needle is used).
5. Open the Blood Pump Cover and remove the Cartridge Blood Set from the
Blood Pump Rotor and the heparin syringe, if present, from the Syringe Holder.
Step 3: Placing the primed Cartridge Blood Set on the PHOENIX machine
previously prepared for continuation of treatment:
1. Open the Blood Pump Cover, by pressing the cover latch, then open the Air
Bubble Detector/Patient Sensor cover.
2. Remove the unprimed Cartridge Blood Set that had previously been placed on the
PHOENIX machine to allow dialysate preparation.
3. Verify the Blood Pump Rotor is in the horizontal position, reposition if necessary.
Rev. B
Note
The Blood Pump cover can be closed only when the rotor is in the horizontal position.
4. Remove the end caps from the venous and arterial access lines of the Cartridge
Blood Set: this exposes the blood side of diaphragms to atmosphere. Allow
approximately 5 seconds for pressure to stabilize on both sides of the diaphragms.
Replace the end caps.
5. Place the pump segment of the Cartridge Blood Set around the Blood Pump Rotor.
6. Insert the tab of the Cartridge Blood Set into the Cartridge Clip (left side of cartridge
holder). Press the Cartridge against the machine. The pressure pods should seat
evenly on the Red and Blue Sealing Cones.
7. Close the Blood Pump Cover. (Cover makes a clicking sound as it latches).
8. Insert the heparin syringe (if present) into the Heparin Syringe Holder and close the
Syringe Holder with the clip to keep it in place.
9. With the (ARROW LEFT) and (ARROW RIGHT) buttons on the Heparin
Control Panel, move the heparin syringe Plunger Clamp to fit the syringe.
10. Place the primed dialyser into the Dialyser Holder.
11. Route the venous line into the Air Bubble Detector/Patient Sensor and through the
Venous Line Clamp.
12. Close the Air Bubble Detector/Patient Sensor Cover (cover makes a clicking sound
as it latches).
13. Route the arterial line into the Arterial Line Clamp (if Single Needle is used).
14. Route the Cartridge access lines into the 4-Position Line Clamp above the Cartridge
Blood Set. Route the lines from right to left as follows:
Heparin line Green clamp

Arterial access line Red clamp (right)
Cartridge saline line Red clamp (left)
(with priming connector)
Venous access line Blue clamp
15. Remove the clamps from the arterial and venous lines to the patient, arterial and
venous dialyser lines, saline administration line and the heparin line (if a syringe is
present).
16. Connect the Dialysate Lines to the dialyser and press BYPASS to reprime the
dialysate side of the dialyser.
17. Wait approximately 30 seconds and then press the PAT CONNECT Action key and
CONFIRM the selection.
18. Start the Blood Pump by pressing the ON/OFF button on the Blood Pump Control
Panel.
19. Override any alarms.
WARNING
During OVERRIDE, the operator is responsible for monitoring parameters, which
are being overriden.
20. Set the treatment parameters for the remainder of the treatment to be performed.
21. Activate Heparin, BPM, UF or Conductivity Profiling if desired.
22. Press the DIALYSIS Action key to reinitiate the treatment.
Rev. B
WARNING
It is the operators responsibility to check that the quantity of heparin delivered to
the patient is enough to prevent blood clots from forming in the extracorporeal
circuit during the transfer of a primed Cartridge Blood Set to another machine.
Following completion of the treatment and return to the IDLE view, before initiating
another treatment on this machine, set the following parameters:
The JUMP PRIMING parameter must be changed to NO From the IDLE view,
select Config/Centre Conf/Functions and change JUMP PRIMING to NO. Press
CONFIRM.
The DIAL AUTO PRIME parameter must be changed to YES, if needed to
perform the Priming Procedure with Dialysate Connectors on the Dialyser. From
the IDLE view, select Config/Centre Conf/Automation and change DIAL AUTO
PRIME to YES. Press CONFIRM.
Rev. B
5.A.18 Installation of the Single Needle Holder
The Single Needle Holder accessory allows SETUP of the Single Needle Cartridge
Blood Set.
Note
The Single Needle Holder can be left on the machine when a double needle treatment is
performed.
The Single Needle holder is provided with a clip connection to latch it to the Dialyser
Holder.
To mount it to the Dialyser Holder, pull out the Dialyser Holder and then press the
Single Needle Holder firmly to the shaft as displayed in Fig. 1.
The Holder must stay in the upright position (see Fig. 2).
Fig. 1 Fig. 2
Rev. B
SECTION 5.B - TEST PROCEDURES 5.B-1
5.B TEST PROCEDURES

5.B SECTION 5.B - TEST PROCEDURES
5.B.1 Test procedures

The machine automatically carries out a series of tests to check the components and
processes that make a dialysis treatment safe.
Some tests are carried out in a precise functioning phase, while the remaining can be
performed in a different machine status, dependent on user manipulations performed.
During the T1 test execution, a bar graph is displayed together with an operator s
message informing the operator that the T1 test execution is in progress and which
specific T1 test the PHOENIX machine is performing.
When the machine is powered ON or after the end of the dialysis treatment, the
machine goes into IDLE. If the machine detects that it is in IDLE for more than a
minute, the T1 Test begins automatically.
Normally when the machine is in IDLE after being powered ON, dialysate connectors
are on their bypass ports and dialysate concentrates are not connected. During this
time, only the tests that do not involve the conductivity probes are performed. In
order to allow the T1 testing to continue, the user needs to connect the appropriate
concentrates, press the SETUP Action key and choose the dialysate type. The
machine will then sequence through each remaining T1 tests automatically.
Normally following completion of a dialysis treatment when the machine returns to

IDLE, the dialysate connectors are on their bypass ports and dialysate concentrates
may still be connected. From IDLE, the user has the opportunity to select the NEW
SESSION Action key which will allow the T1 test to be performed without repeating
the Dialysate Pressure (Pi & Po), Temperature, Conductivity and UF tests. The user is
advised with an Operator Message to confirm the use of the NEW SESSION to
proceed.
If a T1 test passes, the machine continues normal operation. If a T1 test fails, an alarm
message, T1 TEST FAILED, will appear informing the operator of the failure. An
operator s message will inform the operator which specific T1 test failed.
After the successful completion of the test, the related test message disappears from
the window.
Only in the specific case of CPU test failure, the machine gets stuck without displaying
any alarm message.
Following successful completion of all the T1 TESTs, the machine continues normal
operation. If the T1 TEST fails, one of the four possibilities listed below occurs
depending on the seriousness of the condition.
Rev. B
5.B-2 PHOENIX OPERATOR MANUAL
1. WARNING
The operator is advised of the test failure with an alarm message (number 183):
W! T1 Test Failed
(see Section 8 - Alarms and Signals, in this manual)

The machine proceeds with normal operation.
The audible and visual alarm is disabled by pressing the OVERRIDE button.
2. WARNING PLUS USER CONFIRMATION REQUEST

The alarm message (#188) is displayed:
W! Wait to Continue
(see Section 8 - Alarms and Signals, in this manual)
In the Operator Messages Area the following message will appear:
... TEST FAILED.

Press OVERRIDE To Proceed
Note
On the first line of the message the failed test is indicated.
E.g.: The TEMPERATURE TEST Has Failed"
If the operator decides to continue the dialysis treatment despite this test failure, the
OVERRIDE button on the Main Control Panel must be pressed.
When the OVERRIDE button is pressed, the following message appears:

Press STOP to Interrupt the Process
The CONFIRM button must be selected within 2 minutes (i.e. when the OVERRIDE
LED is still lit) to confirm the intention to proceed with the dialysis treatment.
If the CONFIRM button is not pressed, the machine remains in a wait state.
If the operator decides not to continue the treatment and to return to the IDLE view,
the STOP Action key must be pressed.
Note
After pressing the STOP SETUP Action key, wait at least 20 seconds before restarting
again dialysate preparation.
WARNING
It is not advisable to continue treatment, but to notify Service as to which test
failed. It is the operators responsibility to carefully check the parameters involved
in the failed test if the decision is made to continue treatment despite the test
failure.
Rev. B
3. GENERAL SAFE STATE

The machine is placed in a GENERAL SAFE STATE:
Ultrafiltration Pump stops

Blood Pump stops
Venous Clamp closes.
Machine goes into BYPASS
It is impossible to continue with a treatment.

The following message appears in the alarm window:
! T1 Test Failed
In the Operator Message Area the following message will appear:
Failure of the
... Test in Progress...
WARNING
Notify Service as to which test has failed.
4. MACHINE STUCK
Only in the specific case of CPU test failure, the machine gets stuck without displaying
any alarm message.
If this occurs, switch OFF the machine, wait 5 seconds, then switch ON the machine
again.
Rev. B
The table below lists the individual T1 tests, their execution phase (the 2 conductivity
tests can occur outside the normal sequence since they are only executed during
dialysate preparation), and the results of a test failure:
Test Execution phase Failure

1 CPU Test During loading of the program (when Machine
Process control unit Power is switched ON) stuck
In IDLE phase
2 CRC EPR Test During loading of the program (when General
System memory check Power is switched ON) Safe
In IDLE phase State
3 Comparator Test During loading of the program (when General

Internal comparator Power is switched ON) Safe
In IDLE phase State
4 RAM ICs Test During loading of the program (when General

Memory units Power is switched ON) Safe
In IDLE phase State
5 Battery Test During loading of the program (when warning

Power is switched ON)
In IDLE phase
6 Buzzer & Lamp Test During loading of the program (when NA (see
Audible and visual alarms Power is switched ON) warning
In IDLE phase below)
7 free
8 free
9 free
10 24 Volt Test During loading of the program (when General
Power supply Power is switched ON) Safe
At the end of WASHBACK State
11 Venous Clamp Test During loading of the program (when General

Venous line clamp Power is switched ON) Safe
At the end of WASHBACK State
12 free
13 Electrovalves Test At the beginning of dialysate preparation General
Valves command Safe
State
14 Arterial & Venous In IDLE phase General
Pressure Test OR Safe
Venous & Arterial State
At the beginning of dialysate preparation
pressures
15 Blood Pump Test At the beginning of dialysate preparation General
Safe
State
Rev. B
Test Execution phase Failure

16 PI/PO Pressures Test At the beginning of dialysate preparation General
(Note 2) Safe
In- & out-let filter pressure. State
& loss of filter bypass
circuit
17 Temperature Test (Note During the dialysate preparation warning
2) +
confirm.
18 Acid/Acetate During the dialysate preparation warning
Conductivity Test +
Acid/Acetate conductivity confirm.
19 Bicarbonate Conductivity During the dialysate preparation warning
Test +
(Note 1 & 2) confirm.
Bicarbonate conductivity
20 BLD Test During the dialysate preparation warning
Blood Leak Detector +
confirm.
21 Ultrafiltration pump Test During the dialysate preparation General
(Note 2) Safe
Ultrafiltration State
WARNING
During the BUZZER AND LAMP test, the presence of a short audible and visual
signal must be checked (red and yellow lamps illuminated).
If one of the signals is not present, the respective signalling device (buzzer or
lamp) is malfunctioning. Call for Service.
It is NOT recommended to carry out a dialysis treatment in the absence of the
audible and/or visual alarms.
Note 1
The bicarbonate conductivity test is only carried out if Bicarbonate Dialysis/BiCart has
been selected.
Rev. B
Note 2
If the dialysis treatment starts with the NEW SESSION mode selected by the user, the
following T1 Tests are not repeated:
Dialysate (Pi&Po) Pressure
Temperature
Conductivity
Ultrafiltration Pump
The user is advised with the following operator message when the NEW SESSION key is
pressed the first time:
In NEW SESSION Mode The Pi&Po,

Temperature, Conductivity and UF
T1 Tests won't be Performed.
Press ENTER To Confirm And Proceed.
Rev. B
SECTION 5.C - BLOOD PRESSURE MONITORING SYSTEM 5.C-1
5.C BLOOD PRESSURE MONITORING

SYSTEM
5.C SECTION 5.C - BLOOD PRESSURE MONITORING SYSTEM
5.C.1 General
General description
The Blood Pressure Monitoring system (BPM) provides measurement of patient blood
pressures using an inflatable pressure cuff.
Blood pressure data is derived by the oscillometric method.
Once the BPM acquires the pressure data, it analyzes the data to obtain systolic and
diastolic pressure values and the heart rate.
WARNING
If the BPM is not factory installed, carefully follow the instructions supplied with
the BPM kit.
Oscillometric Blood Pressure Measurement Method

The BPM uses a blood pressure cuff to apply pressure to the artery.
The arterial pressure pulses are coupled in the cuff and result in pulses (oscillations)
modulating the cuff pressure.
The maximum amplitude of these oscillometric pulses occurs at mean blood pressure.
The BPM plots the amplitude of the oscillometric pulses against the cuff pressure.
It then interpolates the systolic and diastolic blood pressures from the plot.
Assembly accuracy
Meets ANSI/AAMI standards. SP10.
Overall System Accuracy

Meets ANSI/AAMI SP 10 clause 4.4.2 and EN 1060-3.
The following overall system accuracy values are applied:
a. Maximum mean error of measurement: 5 mmHg
b. Maximum experimental standard deviation: 8 mmHg
Those accuracy values are obtained with a measurement device with an accuracy of:
2% or 3 mmHg, whichever is greater, over a range of 0 to 260 mmHg
(compliant to ANSI/AAMI SP 10 clause 4.4.1).
Pressure cuff measurement ranges
Systolic +40 to +270 mmHg
Diastolic +20 to +250 mmHg
Heart rate 30 to 250 beats/min.
Cycle time
Typical measurement cycle time is less than 60 seconds.
Maximum time is 145 seconds.
Rev. B
5.C-2 PHOENIX OPERATOR MANUAL
Zero setting
No manual action is necessary: the assembly automatically sets the pressure
transducer channel to zero.
Conformity with international standards

The BPM complies with the applicable clauses of the following international
standards:
IEC 60601-2-30
Medical electrical equipment.
Part 2: Particular requirements for the safety of automatic cycling indirect blood
pressure monitoring equipment.
EN 1060-1
Non-invasive sphygmomanometers - General requirements
EN 1060-3
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems.
Composition
The inflation bags and the tube in the BPM cuff are made of a latex-free material.
The external materials of the inflation bags that are in contact with the patient are
made of Dupont Dacron Polyester with the hook and loop closures made of
Dupont Nylon. These materials has been tested by NAMSA (North American
Science Associates) and are in compliance with bio-compatibility standards for
irritation and skin sensitivity.
Cuff cleaning
Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or
cloth soaked in mild soap or water solution.
Cuff pressure
The maximum pressure is 290 mmHg.
In the event of a power failure, the cuff automatically deflates.
The inflation rate is less than 80 mmHg/second.
Rev. B
WARNING
The BPM must be used only for patients with a body weight greater than 15 Kg
and using a BPM cuff of the appropriate size.
Avoid compression or restriction of pressure tubes.
Check (e.g. by observing the limb concerned) that operation of the equipment
does not result in prolonged impairment of the blood circulation of the patient.
The BPM should be tested and calibrated at least once every 4000 hours, or any
time irregular performance is suspected or observed.
Its composition (insulating material) protects the BPM "Applied Part" (Type BF)
against the effect of a defibrillator discharge.
In the event of accidental wetting of the cuff or the hydraulic connections, wipe
immediately to prevent moisture from entering the machine.
WARNING
In order to be in full conformity with the indications of the European Medical
Device Directive 93/42, the manufacturer advises the user that the information
originating from the BPM cannot be used alone as a unique source of information
to induce any therapeutic or pharmacological actions.
Note
Excessive patient movement or speech can interfere with blood pressure measurements.
Make sure that the patient is quiet and not moving during the measurements, just as
during the manual readings.
Rev. B
5.C.2 Cuff selection
Selection of correct cuff size

1. Select the appropriate cuff size as indicated below:
Cuff size Limb circumference (cm) Service code

CHILD 10 19 6975213
(3.9-7.5 in)
SMALL ADULT 18 26 6975221
(7.1-10.2 in)
ADULT 25 35 6975239
(9.8-13.8 in)
LARGE ADULT 33 - 47 6975247
(12.9-18.5 in)
THIGH 46 66 6975254
(18.1-25.9 in)
2. Ensure that the rubber cuff bladder wraps at least halfway around the limb.
Note
The table above contains a number of references to cuffs for use with the Phoenix Blood
Pressure Monitoring System (BPM). The Phoenix machine has been tested and validated for
use with the cuffs listed in this table. The Manufacturer has not validated the use of cuffs
other than those specified in this manual. The Manufacturer does not assume responsibility
or liability for use of cuffs other than those specified. It is the responsibility of the user to
validate that other cuffs provide safe and effective performance.
Common errors in cuff size selection
Cuff size Effect on readings

Too Small False HIGH
Too Large False LOW
For correction to blood pressure reading refer to Correction of blood pressure

readings in this section.
Rev. B
5.C.3 Cuff application
Proper cuff application

1. Select the correct cuff size (see Selection of correct cuff size above).
2. Squeeze air from cuff.
3. Place white arrow on cuff approximately over brachial artery.
4. Wrap cuff snugly, placing upper edge of cuff as high on arm as possible, with
lower edge 25 to 50 mm above the antecubital crease.
5. Cuff is applied correctly when white arrow on cuff is placed on the inner surface of
the arm (not near antecubital crease).
Common errors in cuff application

1. Wrong cuff size
2. Cuff full of air when first applied.
3. Cuff too low on arm (lower edge of cuff must not rest on antecubital crease).
4. Cuff too loose.
Correction of blood pressure readings

When accurate blood pressure measurements are necessary, arm circumferences
should be measured and corrections made using the following table (where SBP and
DBP respectively represent the Systolic and the Diastolic Adult Blood Pressure Cuffs)
Bladder width (cm) 12 (4.7 in) 15 (5.9 in) 18 (7.1 in)

Ideal arm circumference (cm) 30 (11.8 in) 37.5(14.8 in) 45 (17.7 in)
Arm circumference range (cm) 26 - 33 33 - 41 > 41
(inch) (10.2 - 12.9) (12.9 - 16.1) > 16.1
Arm circumference (cm) SBP DBP SBP DBP SBP DBP
26 (10.2 in) +5 +3 +7 +5 +9 +5
28 (11.0 in) +3 +2 +5 +4 +8 +5
30 (11.8 in) 0 0 +4 +3 +7 +4
32 (12.6 in) -2 -1 +3 +2 +6 +4
34 (13.4 in) -4 -3 +2 +1 +5 +3
36 (14.2 in) -6 -4 0 +1 +5 +3
38 (14.9 in) -8 -6 -1 0 +4 +2
40 (15.7 in) -10 -7 -2 -1 +3 +1
42 (16.5 in) -12 -9 -4 -2 +2 +1
44 (17.3 in) -14 -10 -5 -3 +1 0
46 (18.1 in) -16 -11 -6 -3 0 0
48 (18.9 in) -18 -13 -7 -4 -1 -1
50 (19.7 in) -21 -14 -9 -5 -1 -1
Rev. B
For correction of blood pressure readings in individual patients, positive numbers

should be added to and negative numbers subtracted from the readings obtained.
(The table data is taken from the American Heart Association).
5.C.4 BPM User interface

When selecting BPM from the Home view, the blood pressure monitoring
environment is accessed.
After having correctly positioned the cuff on the arm of the patient, a new blood
pressure measurement can be taken by:
Selecting the HEART button on the Main Control Panel. The BPM
measurement can be performed in the DISINFECT or RINSING modes, or from
the IDLE view, as well as during TREATMENT. Only the pressure values, measured
starting from the Patient Login even throught EMPTYING, are stored in the
REPORT screen (see Section 7 - Communication System) on the lines between the
Start and the Stop of Acquisition of events.
or
Depending on the operating phase of the machine, pressing one of the following
Action keys:
- PRE STANDING
- PRE SITTING
- PRE LYING
- POST STANDING
- POST SITTING
- POST LYING
The measure taken is linked to the parameter related to the specific type of
measure performed, and is stored in the Dialysis Report table (see Section 7 -
Communication System) in the lines reserved for the PRE/POST DIALYSIS DATA.
Note
Only during the time between the Patient Login event, and the TREATMENT process
selection, the following Action keys will be available: PRE STANDING, PRE SITTING,PRE
LYING.
Only during the time between the DIALYSIS Action key disappearance (after the
RINSEBACK VOLUME value set has been reached) and the Patient Login event for the
next dialysis treatment, the following Action keys will be available: POST STANDING,
POST SITTING,POST LYING.
(See Section 7 - Communication System).
Rev. B
Note
When the BPM device is not connected a specific alarm is triggered.
The BPM view has the following form:
12:30 TREATMENT
-- / --
--- / --- mmHg
--- pu/min
STOP
BPM ON
PRE STANDING
VEN ART
PRE SITTING
BLOOD FLOW
PRE LYING
BLOOD FLOW
<< TIME Clk Time Syst Dias H RATE >>
BPM REPORT KT/V PROFILE HEPARIN MACH.CONF
A graph is displayed on the BPM view showing the patients blood pressure
measurements:
The last measurement of the systolic pressure (Ps): red line
The last measurement of the diastolic pressure (Pd): yellow line.
A graph on the BPM view displays heart rate measurements.

The last measurement of the pulse rate (h/r): red line.
Three pointers on the graphs mark respectively:

The LOG event: starting when the machine enters the IDLE phase. Under the base
line of the graph the time in which the LOG event occurred is displayed.
The INIT event: selection of the DIALYSIS Action key. Under the base line of the
graph the time 00:00 is displayed.
Rev. B
The END event: end of the dialysis treatment is indicated either by selecting POST
STANDING/POST SITTING/POST LYING, if pressed before the EMPTYING Action
key selection, or by selecting the EMPTYING Action key. Under the base line of
the graph the time at which the END event occurred is displayed, measured by the
INIT event.
Entering the BPM view a green cursor is positioned on the last BPM measurement.
Pressing the Function Bar Arrows (positioned on the lower part of the window) moves
the position of the green cursor on the patients blood pressures and heart rate
graphs, in correspondence to the BPM measurements.
Note
To prevent problems in the BPM graph visualization, do not press simultaneously the two
Function Bar Arrows.
Note
The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the
arrows for more than 2 seconds allows the green cursor to move more quickly on the
graph.
The Function Bar displays the following values at the point in time at which the green
cursor is positioned on the graph:
The time into treatment ( Time)
The clock time (Clk Time)
The systolic pressure value (Syst)
The diastolic pressure value (Dias)
And the heart rate measurement (H Rat) for the point in time at which the green
cursor is positioned on the graph (Time).
In the time interval between the INIT event and the END event, the Time value
displayed in the Function Bar, is calculated starting from the DIALYSIS Action key
selection (i.e. INIT event); in the time interval before INIT event and after END event,
the Time value corresponds with the Clk Time value.
Both the BPM graphs and the BPM data collected during a treatment and displayed in
the Function Bar remains available in the BPM view until the Patient Login event for
the next dialysis treatment is triggered.
Note
The BPM area is shown in each view, it displays the last BPM measurement data. Data
displayed in this area are not deleted by the Patient Login event.
Note
The base of the graph corresponds to zero and the top to the maximum permitted value.
Select the Home Navigation key to return to the Home view.
Press the STOP Action key to stop the measurement.
Rev. B
During the dialysis treatment, press the BPM ON Action key to enable automatic
pressure measurements at time intervals corresponding to the value set for the
SAMPLE INTERV parameter on the Config/Treatments/BPM screen or on the Rx
Config/Rx Add, if using Patient/Rx dialysis.
When automatic pressure measurements are enabled, the BPM ON Action key is
highlighted and the heart icon appears in the Icon bar.
To turn off the automatic pressure measurements, select the BPM ON Action key
again.
The BPM ON Action key will no longer be highlighted.
Note
The HEART icon flashes for a minute before an automatic measurement.
BPM measurements can be performed in the DISINFECT or RINSING modes, or from

the IDLE view as well as during TREATMENT.
At the start of any process (TREATMENT/DISINFECT/RINSING and on the IDLE view)
the machine uses the BPM parameters set in the Config/Treatments/BPM menu.
Note
The BPM USE parameter, settable both during STD DIALYSIS and during Patient
DIALYSIS, may be programmed in the Configuration menu as follow:
NO only manual measurements are possible

YES measurements performed by the machine at each SAMPLE INTERV
time
AUTOMATIC the first measurement is performed by the machine immediately after
the selection of the TREATMENT Action key, additional
measurements are performed at each SAMPLE INTERV time.
Manual BPM measurements may be performed at any time by pressing the button.
Rev. B
By using the SET mode, in the BPM view, the value of the parameters relating to the
measurements may be modified:
12:30
TREATMENT
DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX
HEART R. MIN HEART R. MAX SAMPLE INTERV
HOME BPM REPORT KT/V PROFILE HEPARIN
DIAST PRE MIN Minimum threshold of the range of values within which the
diastolic pressure must fall.
DIAST PRE MAX Maximum threshold of the range of values within which the
diastolic pressure must fall.
SYST PRE MIN Minimum threshold of the range of values within which the
systolic pressure must fall.
SYST PRE MAX Maximum threshold of the range of values within which the
systolic pressure must fall.
HEART R. MIN- Minimum threshold of the range of values within which the pulse
rate must fall.
HEART R. MAX- Maximum threshold of the range of values within which the pulse
rate must fall.
SAMPLE INTERV- Time interval between two successive automatic BPM
measurements.
Note
When a diastolic pressure, systolic pressure or heart rate measurement is outside the
minimum or maximum thresholds, a corresponding alarm is activated which can be reset
with the OVERRIDE button.
Rev. B
SECTION 5.D - PROFILE 5.D-1
5.D PROFILE
5.D SECTION 5.D - PROFILE
5.D.1 Introduction
In order to make the dialysis treatment more effective, ultrafiltration rate and final
conductivity value can be set so that they follow a predetermined curve during the
dialysis treatment in progress. That can be done by entering the PROFILE
environment.
Three curve types can be set for each parameter:

CONSTANT
STEP
PROGRESSIVE
The CONSTANT curve type corresponds to a Dialysis Mode with Profiling not
enabled: i.e. ultrafiltration rate and/or conductivity and all the relevant parameters are
constant during the patient treatment.
By setting the curve type to STEP or to PROGRESSIVE the parameters for conductivity
and ultrafiltration may be varied during the treatment following a predetermined
profile. (See 5.D.1.1 CURVE TYPE Setting, in this section, for the description of how
to set the CURVE TYPE parameter).
Each configured Profile curve can be stored in the machines memory as a global
Profile curve or it can be stored in the Patient/Rx Action keys as an individualized
Profile curve. By selecting a Patient/Rx Action key the pre-programmed Profile that
was stored in that Patient/Rx Action key will be activated. (Refer to Section 05
Dialysis Operation, in this manual, for a detailed description of the Patient/Rx Dialysis).
Depending on the values set for the CURVE TYPE parameter in the
CONFIGURATION view, the Standard Dialysis Mode may be programmed with or
without profiling. (Config/PROFILE/UF and Config/PROFILE/Cond.
Each of the Patient Action keys can be programmed in the CONFIGURATION view
to different profiles or to different combinations of profiles, depending on the values
set for the CURVE TYPE parameter. (Rx Config/PROFILE/UF and Rx
Config/PROFILE/COND).
Rev. B
5.D-2 PHOENIX OPERATOR MANUAL
5.D.1.1 CURVE TYPE Setting

The CURVE TYPE parameter can be set both in Configuration (Idle phase) and during
Dialysis.
IN CONFIGURATION (in Idle phase)

Press Config/PROFILE/UF and Config/PROFILE/Cond to gain access to the global
profile parameters both for ultrafiltration rate and for final conductivity.
Press Rx Config/PROFILE/UF and Rx Config/PROFILE/COND to gain access to the
individualized (Patient/Rx) profile parameters, both for ultrafiltration rate and for final
conductivity.
In each view, press the SET button to allow access to the view where it is possible to
modify the parameter value; below is an example of Config\PROFILE\UF view:
12:30
Kg/h
Kg/h 4.00
ULTRAFILTRATION
3.00
2.00
1.00
0.00
0:00 1:00 2:00 3:00 4:00 h:min
h:min
CURVE TYPE TOT WEIGHT L INITIAL VALUE CURVE COEFF

PROGRESSIVE 4Kg 1.4 Kg/h 20%
CONFIG PROFILE UF COND
Press the CURVE TYPE Parameter Box. The background colour of the entry field will
change from gray to yellow and a new view will appear where the three possible
selections for the parameter are available: CONSTANT, STEP, PROGRESSIVE.
Select the desired value and then press the CONFIRM button to accept the modified
value; the profile will change to represent the new value entered.
Press the SET button to exit this view.
Changes to the CURVE TYPE parameter made in the CONFIGURATION view are
retained in the machines memory.
Rev. B
STARTING FROM PREPARATION

Press PROFILE/UF and PROFILE/Cond Navigation key to gain access to the global
profile parameters both for ultrafiltration rate and for final conductivity.
Follow the same procedure described above for the CONFIGURATION view.
Changes to the CURVE TYPE parameter made in those pages are only temporary; i.e.
they only remain until the end of the current dialysis treatment.
The CURVE TYPE parameter value, both for ultrafiltration rate and for final
conductivity, can be changed until the PAT CONNECT Action key selection.
If the CURVE TYPE parameter and/or the CON CURVE TYPE parameter are set to
STEP or PROGRESSIVE the PAT CONNECT Action key will not appear until the
profiles have been activated. Select ACTIVATE UF RATE CURVE and/or ACTIVATE
CONDUCT. CURVE in the PROFILE view to activate profiles.
An operators message is displayed at the end of the priming phase stating that
Profiling must be activated to make the PAT CONNECT Action key available:
The Profiling Mode has been selected

Please activate Profiling to get PAT CONNECT
Rev. B
5.D.2 Dialysis Mode with Profiling not enabled
If the CURVE TYPE or/and the CON CURVE TYPE parameter is/are set to
CONSTANT, changes to the UFR or/and CONDUCTIVITY value(s) can be done only
by an operator intervention.
5.D.2.1 Display UFR and Conductivity graph in Dialysis Mode

with Profiling not enabled
When selecting PROFILE Navigation key the following view appears.
12:30
-- / ----- / ---mmHg
--- pu/min
DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg

Kg/h ULTRAFILTRATION
4.00 CURVE TYPE
CONSTANT
3.00
UFR
1.800 Kg/h
2.00
1.00 TOTAL FLUID

REMOVED
0.00 1.800 Kg/h
0:00 1:00 2:00 3:00 4:00
VEN ART
Time h:min
mS/cm CONDUCTIVITY
17.0 CON CURVE
BLOOD FLOW TYPE
16.0 CONSTANT
15.0 CONDUCTIVITY
14.6 mS/cm
14.0
13.0
PUMP SPEED 0:00 1:00 2:00 3:00 4:00
Time h:min
PROFILE UF COND
Note
When the CURVE TYPE parameter is set to CONSTANT, the ACTIVATE UF RATE CURVE
Action key is not available in the PROFILE view.
When the CON CURVE TYPE parameter is set to CONSTANT, the ACTIVATE CONDUCT.
CURVE Action key is not available in the PROFILE view.
Rev. B
UF view
When selecting PROFILE\UF the following view appears. Both the UFR value set and
the achieved UFR values are displayed in the Parameter Area.
12:30
-- / -- --- / --mmHg
--- pu/min
ULTRAFILTRATION
Kg/h
4.00
3.00
2.00
1.00
VEN ART
0.00
0:00 1:00 2:00 3:00 4:00
BLOOD FLOW Time h:min
CURVE TYPE CONSTANT
e f
PUMP SPEED Time Clock Time UF R Curr
01:90 12:30 1.4 1.4
PROFILE UF COND
Note
When the CURVE TYPE parameter is set to CONSTANT, changes to the UFR and TOT
WEIGHT L parameter values can be made only from the Home view in Set mode.
The red curve on the graph represents the last value set for the UFR parameter, while
the yellow curve represents the achieved UFR values.
Entering the PROFILE\UF view a green cursor is positioned on the current UFR value.
the position of the green cursor on the UF Profile graph.
Note
To prevent problems in the Profile graph visualization, do not press simultaneously the two
Note
The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows
for more than 2 seconds allows the green cursor to move more quickly on the graph.
The time into treatment (Time)
The clock time (Clock Time)
The last value set for the UFR parameter (UFR)
The UFR current value (Curr) for the point in time at which the green cursor is
positioned on the graph (Time).
Press any Navigation key to exit from this view.
Rev. B
COND Profile
When selecting PROFILE\Cond, the following view appears. Both the configured
Conductivity Profile and the achieved Conductivity values are displayed in the
Parameter Area.
12:30
-- / --
--- / ---mmHg
--- pu/min
mS/cm CONDUCTIVITY
17.0
16.0
15.0
14.0
13.0
VEN ART 0:00 1:00 2:00 3:00 4:00
Time h:min
BLOOD FLOW
CON CURVE TYPE CONSTANT
Plasma Conduct. 13.5 mS/cm
Ionic Mass Bal nmol
e f
PUMP SPEED Time Clock Time Cond Curr
02:00 12:30 14.5 14.5
PROFILE UF CON
Note
When the CON CURVE TYPE parameter is set to CONSTANT, changes to the
CONDUCTIVITY parameter value can be made only from the Home view in Set mode.
The red curve on the graph represents the last value set for the CONDUCTIVITY
parameter, while the yellow curve represents the achieved CONDUCTIVITY values.
Entering the PROFILE\Cond view a green cursor is positioned on the current
Conductivity value.
the position of the green cursor on the Conductivity Profile graph.
Note
Note
The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows
for more than 2 seconds allows the green cursor to move more quickly on the graph.
The clock time (Clock Time)
The last value set for the CONDUCTIVITY parameter (CON)
The CONDUCTIVITY current value (Curr) for the point in time at which the
green cursor is positioned on the graph (Time).
Rev. B
The PLASMA CONDUCTIVITY and IONIC MASS BALANCE values are displayed
only if the DiascanTMMonitoring System is active and a Clearance measurement has
been taken. (See Section 5.E Monitoring, in this manual, for a detailed description
of these parameters).
5.D.2.2 DIALYSIS TIME Setting
When both the CURVE TYPE and CON CURVE TYPE parameters are set to
CONSTANT, the DIALYSIS TIME parameter can be changed:
IN CONFIGURATION (in Idle phase):

by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx
Config\Rx Data view for Patient/Rx Dialysis.
Changes to the DIALYSIS TIME parameter during Idle phase are stored in the
machines memory.
STARTING FROM PREPARATION:

by pressing the SET button in the Home view;
by pressing the SET button in the PROFILE view.
The value set for the DIALYSIS TIME parameter in the HOME view is automatically
displayed in the PROFILE view and vice versa.
Note
Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current
treatment.
Note
Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in
the PROFILEview.
When one of the two parameters CURVE TYPE and CON CURVE TYPE is not set to
CONSTANT, the DIALYSIS TIME parameter can be changed:

Config\Rx Data view for Patient/Rx Dialysis;
by pressing the SET button in the Config\PROFILE view or in the Rx
Config\PROFILE view for Patient/Rx Dialysis.
Rev. B
In STANDARD DIALYSIS:
When the Dialysate Selection key is pressed in the SELECT DIALYSATE view, the
DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to
the time set in the Config/Treatments/Std Dialys view. The treatment time and the
profile time automatically become the same.
In PATIENT/RX DIALYSIS:
In Patient/Rx Dialysis, the value set for the DIALYSIS TIME parameter in the Rx
Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and
vice versa. The treatment time and the profile time automatically become the same.
Note
Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machines
memory.
DIALYSIS TIME may be changed before activating UF and/or CON Profiling curve:
The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS
TIME in the PROFILE view automatically are changed to the same time.
After activating UF and/or CON Profiling curve:

After deactivating either the UF or the CON Profiling curve and one curve remains
active:
After deactivating both UF and CON Profiling curve:

by pressing the SET button in the Home view.
Note
Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in
the PROFILE view.
Rev. B
5.D.3 Profiled Dialysis Mode
5.D.3.1 General
A Profiled Dialysis can be divided into two different phases:
Configuration phase, i.e. definition of the profile curve. The Configuration phase is
accessible from the CONFIG menu when the machine is in IDLE Mode.
Activation phase, accessible from the PROFILE view. In the Activation phase, the
Profile attributes can be changed (except during the last 15 minutes of DIALYSIS)
and the profile curves can be activated and deactivated.
Note
There are only two Profiles configured in the CONFIG menu for both conductivity and
ultrafiltration (default Profiles configured by the Manufacturer): a Global Profile and a
Patient/Rx Profile.
WARNING
graph.
Rev. B
5.D.3.2 Entering the PROFILE View
IN CONFIGURATION (in Idle phase)

Press Config/PROFILE/UF or Config/PROFILE/Cond to gain access to the global
profile parameters.
Press Rx Config/PROFILE/UF or Rx Config/PROFILE/COND to gain access to the
Patient/Rx profile parameters.
Refer to Section 02 Configuration Description, in this manual, for a detailed
description of the configuration environment.
Changes to the profiles parameters made in those pages are retained in the machines
memory.
DURING DIALYSIS
Select the PROFILE Navigation key to gain access to the profile parameters
configured in the machines memory; below is an example of PROFILE view with
Progressive curves:
12:30
-- / --
--- / --- mmHg
--- pu/min

ACTIVATION
CURVE TYPE
UF RATE CURVE
4.00
PROGRESSIVE
3.00
UFR
0.000 Kg/h
2.00
1.00 TOTAL FLUID

REMOVED
0.00 0.000 Kg/h
VEN ART 0:00 1:00 2:00 3:00 4:00 ACTIVATION
Time h:min
mS/cm CONDUCTIVITY CONDUCT. CURVE
BLOOD FLOW 17.0 CON CURVE TYPE
PROGRESSIVE
16.0
CONDUCTIVITY
15.0 0.0 mS/cm
14.0
PUMP SPEED 13.0

0:00 1:00 2:00 3:00 4:00
Time h:min
PROFILE UF COND
Changes to the profiles parameters made from the Profile views are only temporary;
i.e. they only remain until the end of the current dialysis treatment. Thus any changes
made cannot be saved in memory.
Rev. B
5.D.3.3 Progressive Curve Profiles
This type of Profile allows programming the Ultrafiltration Rate and the Conductivity
value so that, during the dialysis treatment, they follow a predetermined, continuous
progressive graph.
5.D.3.3.1 Conductivity Progressive Curve Profiles: parameters explanation
A conductivity profile may be established in the machines memory on the

Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view.
A conductivity profile may be configured for the current treatment in the
PROFILE\Cond view:
INITIAL VALUE: Initial value of Conductivity

FINAL VALUE: Final value of Conductivity
CURVE COEFF: coefficient of the curvature of the progressive curve.
This parameter can range from 20 % to 80 %
DIALYSIS TIME: Length of the dialysis treatment. Set on the PROFILE view or in the
Config\PROFILE view or in the Rx Config\PROFILE view.
If a Conductivity Progressive curve is set with:

INITIAL VALUE= 17
FINAL VALUE= 14
DIALYSIS TIME= 4 h:min
CURVE COEFF= 50 %
The following graph is shown:
17 mS/cm
CURVE COEFFICIENT=
50 %
INITIAL
VALUE = 17 FINAL VALUE = 14
13 mS/cm 4 h:min
Rev. B
Increasing the CURVE COEFF, creates the curve as follows:
17 mS/cm CURVE COEFFICIENT =

65%
INITIAL
VALUE = 17
FINAL VALUE = 14
13 mS/cm 4 h:min
The greater the value for the CURVE COEFF (max 80%), the more convex the profile
curve will become.
If the CURVE COEFF has a value less than 50%, the profile curve will have a concave
shape, as shown below:
CURVE COEFFICIENT=
17 mS/cm
35%
INITIAL
VALUE = 17
FINAL VALUE = 14
13 mS/cm 4 h:min
5.D.3.3.2 Ultrafiltration Rate Progressive Curve Profiles: parameters explanation
An Ultrafiltration Rate Profile may be established in the machines memory in the

Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view.
A conductivity profile may be configured for the current treatment in the PROFILE\UF
view:
TOT WEIGHT L: Target Weight Loss (instead of FINAL VALUE).

INITIAL VALUE: Initial value of the Ultrafiltration Rate.
CURVE COEFF: coefficient of the curvature of the progressive curve.
This parameter can range from 20% to 80%
DIALYSIS TIME: Length of dialysis treatment. Set on the PROFILE view or in the
The methods of inserting the UFR parameters are the same as those illustrated for the
Conductivity parameters.
Rev. B
5.D.3.3.3 Programming the Progressive Curve
WARNING
The physician is responsible for ensuring that the chosen profiles are appropriate
for the patient being treated.
An Ultrafiltration Rate Progressive Profile may be established in the machines

memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE \UF view.
An UFR profile may be configured for the current treatment in the PROFILE\UF view.
Press the SET button to allow access to a view where it is possible to modify the
profile attributes; below is an example of Config\PROFILE\UF view:
12:30
Kg/h
Kg/h 4.00
ULTRAFILTRATION
3.00
2.00
1.00
0.00
0:00 1:00 2:00 3:00 4:00 h:min
h:min
CURVE TYPE TOT WEIGHT L INITIAL VALUE CURVE COEFF

PROGRESSIVE 4Kg 1.4 Kg/h 20%
Rev. B
A Conductivity Progressive Profile may be established in the machines memory in the

A Conductivity profile may be configured for the current treatment in the
PROFILE\Cond view.
Press the SET button to allow access to a view where it is possible to modify the
profile attributes; below is an example of Config\PROFILE\Cond view:
12:30
Kg/h
Kg/h 4.00
CONDUCTIVITY
3.00
2.00
1.00
0.00
0:00 1:00 2:00 3:00 4:00 h:min
h:min
CON CURVE TYPE INITIAL VALUE FINAL VALUE CURVE COEFF

PROGRESSIVE 15.0 mS/cm 13.5 mS/cm 20%
Both for UFR and Conductivity profiles:

Press the Parameter Box to be changed on the Touch Screen. The background
colour of the entry field will change from gray to yellow.
To change a parameter with a string value, after touching the parameter box area,
another view will appear with the possible selections for that parameter. Select the
desired value.
To change a parameter with a numeric value, press the PLUS or MINUS buttons
on the Main Control Panel.
Press the CONFIRM button to accept the modified value; the profile will change
to represent the new value entered. If another parameter is selected and changed
before pressing the CONFIRM button, only the last change is retained in memory.
Press the SET button to return to the view where the profile is displayed. The
modified profile is displayed in the Parameter area.
Rev. B
5.D.3.4 Step Curve Profiles
This type of Profile allows the Ultrafiltration Rate and the Final Conductivity value to
be programmed in 15 minute intervals of treatment time.
WARNING
The physician is responsible for ensuring that the chosen profiles are appropriate
for the patient being treated.
5.D.3.4.1 Ultrafiltration Rate Step Curve Profiles
An Ultrafiltration Rate Step Profile may be established in the machines memory in the
Config\PROFILE\UF view or in the Rx Config\PROFILE\UF view.
An Ultrafiltration Rate Step Profile may be configured for the current treatment in the
PROFILE\UF view.
Below is an example of Config\PROFILE\UF view in Set mode:
12:30
Kg/h STEP UF RATE

4.00
3.00
2.00
1.00
0.00
0:00 1:00 2:00 Time 3:00 h:min 4:00
3 4
TIME UF R
0:00 1.7
CURVE TYPE TOT WEIGHT L STEP UFR

STEP 4 Kg 1.7 Kg/h
TOT WEIGHT L: Target Weight Loss.

STEP UFR: UFR value for the selected step (a 15 minute segment of the treatment).
The Ultrafiltration Rate Step Curve is programmed by selecting and setting each step
(15 minute segment) of the treatment. The selected step is red highlighted, all the
other steps are yellow highlighted.
Rev. B
5.D.3.4.2 Conductivity Step Curve Profiles
A Conductivity Step Profile may be established in the machines memory in the

A Conductivity Step Profile may be configured for the current treatment in the
PROFILE\Cond view.
Below is an example of Config\PROFILE\Cond view in Set mode:
12:30
mS/cm STEP COND

17.0
16.0
15.0
14.0
13.0
0:00 1:00 2:00 Time 3:00 4:00
h:min
3 4
TIME COND
0:00 14.7
CON CURVE TYPE COND STEP

STEP 14.7 mS/cm
COND STEP: Conductivity value for the step (a 15 minute segment of the treatment).
The Conductivity Step Curve is programmed by selecting and setting each step (15
minute segment) of the treatment. The selected step is red highlighted, all the other
steps are yellow highlighted.
Rev. B
5.D.3.4.3 Programming the Step Curve
To select each bar (a 15 minute segment of the treatment) on the Step curve, press
the Function Bar Arrows (located just below the graph), to move the red highlighted
area to the right or to the left, as desired. The bar that is red highlighted is the current
selection. The Starting Time and the UFR value/Conductivity value for the red
highlighted bar is displayed.
By selecting the STEP UFR Parameter Box on the PROFILE\UF or Config\PROFILE\UF
view or in the Rx Config\PROFILE\UF view, it is possible to change the UFR value for
the selected 15 minute Step. Changing the UFR value, for the selected step, also
results in a change to the TOT WEIGHT L, which is automatically updated.
Changing the DIALYSIS TIME value results in a change to the UF Rate, which is
automatically updated, while the TOT WEIGHT L remains constant.
Similarly, by pressing the COND STEP Parameter Box on the PROFILE\Cond or
Config\PROFILE\Cond view, it is possible to change the Conductivity value for the
selected 15 minute Step.
Note
In Config\PROFILE, after a Step has been programmed, the following Step is
automatically selected. By pressing the CONFIRM button, that Step is programmed to the
previously confirmed UF R/Cond value.
Rev. B
5.D.3.5 Modify Profile Parameters

Note
None of the profile parameters can be changed in the last 15 minutes of DIALYSIS.
DIALYSIS TIME
The DIALYSIS TIME parameter can be changed:

Config\Rx Data view for Patient/Rx Dialysis;
Config\PROFILE view for Patient/Rx Dialysis.
In STANDARD DIALYSIS:
When the Dialysate Selection key is pressed in the SELECT DIALYSATE view the
DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to
the time set in the Config/Treatments/Std Dialys view. The treatment time and the
profile time automatically become the same.
In PATIENT/RX DIALYSIS:
In Patient/Rx Dialysis, the value set for the DIALYSIS TIME parameter in the Rx
Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and
vice versa. The dialysis time and profile time automatically become the same.
Note
Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machines
memory.
DIALYSIS TIME may be changed before selecting ACTIVATION UF RATE CURVE

Action key or/and ACTIVATE CONDUCT. CURVE Action key:
The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS
TIME parameter in the PROFILE view automatically are changed to the same time.
After selecting ACTIVATION UF RATE CURVE Action key or/and ACTIVATION

CONDUCT. CURVE Action key:
After deselecting both the ACTIVATION UF RATE CURVE Action key and the
ACTIVATION CONDUCT. CURVE Action key deselection:
Rev. B
After deselecting either the ACTIVATION UF RATE CURVE or the ACTIVATION

CONDUCT. CURVE and one of the curves remains active:
Note
Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current
treatment.
Note
Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity profiles.
Note
The minimum DIALYSIS TIME that may be set in the PROFILE view is 30 minutes.
Note
If the DIALYSIS TIME parameter value is decreased below the treatment time already
elapsed, the UFR measurements will not be recorded by the machine and the UFR Profile
graph will not display correct UFR values.
TOT WEIGHT L
When the CURVE TYPE is set to STEP or to PROGRESSIVE, the TOT WEIGHT L
parameter can be changed:
Config\PROFILE view for Patient (Rx) Dialysis.
Note
Changes of the TOT WEIGHT L parameter during Idle phase are stored in the machines
memory.
Before ACTIVATION UF RATE CURVE Action key selection:

by pressing the SET button in the PROFILE\UF view.
After ACTIVATION UF RATE CURVE Action key selection:

by pressing the SET button in the PROFILE\UF view.
Note
After UFR profile activation, the PAT CONNECT Action Key will not appear until the TOT
WEIGHT L parameter value is confirmed in the PROFILE/UF view.
Note
After UFR profile activation, if the TOT WEIGHT L parameter is changed during the Pt.
Connect phase, the updated TOT WEIGHT L parameter value is not displayed in the
Home view until the selection of the DIALYSIS Action key.
After ACTIVATION UF RATE CURVE Action key deselection:
Change of the TOT WEIGHT L parameter during DIALYSIS effects only the current
treatment.
Rev. B
INITIAL VALUE (COND), FINAL VALUE (COND), CURVE COEFF (COND),

INITIAL VALUE (UFR), CURVE COEFF (UFR), COND STEP and STEP UFR
The INITIAL VALUE (COND), FINAL VALUE (COND), CURVE COEFF (COND),
INITIAL VALUE (UFR), CURVE COEFF. (UFR), COND STEP and STEP UFR parameters
can be changed:
by pressing the SET button in the Config\PROFILE\UF view or in the
Config\PROFILE\Cond view, depending on the parameter;
in the Rx Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view,
depending on the parameter, for Patient /Rx Dialysis.
Note
Changes of those parameters during Idle phase are stored in the machines memory.
Before and after profiles activation and during the time profiles remain activated:
by pressing the SET button in the PROFILE\UF or in the PROFILE\Cond view,
depending on the parameter. (See 5.D.3.3 Progressive Curve Profiles and
5.D.3.4 Step Curve Profiles for a detailed description of the profile parameters).
Note
After the DIALYSIS Action key selection, when a profile is deactivated, none of the
relevant parameters are available in the PROFILE view for the deactivated profile. Those
parameters become available in the Home view.
Note
Change of those parameters during DIALYSIS effects only the current treatment.
Rev. B
5.D.3.6 Activation of Profile
Activation of UFR or CONDUCTIVITY Profile

Press the PROFILE Navigation key to access the PROFILE view:
12:30
-- / --
--- / ---mmHg
--- pu/min

ACTIVATION
4.00 CURVE TYPE UF RATE CURVE
PROGRESSIVE
3.00
UFR
0.000 Kg/h
2.00
TOTAL FLUID
1.00
REMOVED
0.00 0.000 Kg/h
0:00 1:00 2:00 3:00 4:00
VEN ART ACTIVATION
Time h:min
mS/cm CONDUCTIVITY
CON CURVE TYPE
CONDUCT. CURVE
17.0
BLOOD FLOW PROGRESSIVE
16.0
CONDUCTIVITY
15.0 0.0 mS/cm
14.0
13.0
PUMP SPEED 0:00 1:00 2:00 3:00 4:00
Time h:min
PROFILE UF COND
Note
The ACTIVATION UF RATE CURVE Action key is available only if the CURVE TYPE
parameter is set to STEP or to PROGRESSIVE.
The ACTIVATION CONDUCT. CURVE Action key is available only if the CON CURVE
TYPE parameter is set to STEP or to PROGRESSIVE.
To activate PROFILE, press the ACTIVATION UF RATE CURVE and/or the

ACTIVATION CONDUCT. CURVE Action keys. The Action keys are highlighted
when profile is activated and the PROFILE icon appears in the Icon Bar on the left side
of the Touch Screen.
PROFILE must be activated (selection of the ACTIVATION UF RATE CURVE Action

key or/and of the ACTIVATION CONDUCT. CURVE Action key) before patient
connection phase in order to make the PAT CONNECT Action key available.
Note
The ACTIVATION UF RATE CURVE Action key and the ACTIVATION CONDUCT.
CURVE Action key are not available in the treatment phase between the PAT CONNECT
Action key selection and the following DIALYSIS Action key selection.
Rev. B
Once PROFILE has been activated, a change of the CURVE TYPE parameter value will
automatically deactivate PROFILE. If the new CURVE TYPE parameter value is STEP or
PROGRESSIVE, the action key must be activated again for that PROFILE. If the new
CURVE TYPE parameter value is CONSTANT, the ACTIVATION UF RATE CURVE
Action key or/and the ACTIVATION CONDUCT. CURVE Action key is/are no longer
available.
Note
When UFR Profile is activated, the UFR parameter value is not modifiable from the
HOME view in Set mode.
When CONDUCTIVITY Profile is activated, the CONDUCTIVITY parameter value is not
modifiable from the HOME view in Set mode.
Note
After UFR profile activation, if the TOT WEIGHT L parameter is changed during the Pt.
Connect phase, the updated TOT WEIGHT L parameter value is not displayed in the Home
view until the selection of the DIALYSIS Action key.
Note
When Profiling is active, the END DIALYSIS parameter can not be modified.
Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the
current dialysis prescription.
The END DIALYSIS parameter becomes available again at Profiling deactivation (See
5.D.3.8 Deactivation of Profiling, in this section, for the description of a detailed
description of Profiling deactivation conditions).
Rev. B
5.D.3.7 Profile during Dialysis
Once the DIALYSIS Action key has been selected, only the remaining part of the
curve, both PROGRESSIVE and STEP, can be changed.
When selecting the PROFILE Navigation key, the following view is displayed.
12:30 TREATMENT
DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg ACTIVATION

4.00 CURVE TYPE
UF RATE CURVE
PROGRESSIVE
3.00
UFR COMPENSATION
0.000 Kg/h
2.00
1.00 TOTAL FLUID

REMOVED
0.00 0.000 Kg/h
0:00 1:00 2:00 3:00 4:00
ART VEN Time h:min ACTIVATION
mS/cm CONDUCTIVITY
17.0 CON CURVE CONDUCT. CURVE
TYPE
BLOOD FLOW 16.0
CONDUCTIVITY
15.0 0.0 mS/cm
14.0
13.0
0:00 1:00 2:00 3:00 4:00
PUMP SPEED Time h:min
PROFILE UF COND
The ACTIVATION UF RATE CURVE and ACTIVATION CONDUCT. CURVE are

available to deactivate Profile for a parameter.
The COMPENSATION Action key is displayed only if there is a Error On Total

Weight Loss #60 alarm (difference between theoretical and actual Fluid Removed >
100 grams). It may be displayed at any time during the dialysis treatment except in
the last 30 minutes.
In addition to the COMPENSATION Action key, an icon is also displayed which
represents whether the FLUID REMOVAL ERROR is in the positive or in the negative
direction.
When pressing the COMPENSATION Action key, the following superimposed
window will appear:
Compensation has been request.

Press ENTER To Confirm..
Upon pressing the CONFIRM button, a new curve is confirmed and used for the
remainder of the DIALYSIS treatment.
Rev. B
If the Error On Total Weight Loss #60 alarm appears in the last 30 minutes of
dialysis treatment or if the alarm has not been cleared before the COMPENSATION
Action key disappears (last 30 minutes of dialysis treatment), the following operators
The Profiling Mode Cannot Continue

Deactivate it and Continue in STD Mode
To proceed with the dialysis treatment, deactivate PROFILING.
Rev. B
5.D.3.7.1 Display Profile during DIALYSIS
UF Profile
When selecting PROFILE\UF the following view appears. Both the configured UFR
Profile and the achieved UFR values are displayed in the Parameter Area. An
example of Progressive UF profile is displayed:
12:30
-- / -- --- / --- mmHg
--- pu/min
ULTRAFILTRATION
Kg/h
4.00
3.00
2.00
1.00
VEN ART
0.00
0:00 1:00 2:00 3:00 4:00
BLOOD FLOW Time h:min
CURVE TYPE PROGRESSIVE INITIAL VALUE 1.500 Kg/h
TOT WEIGHT L 4.000 Kg/h CURVE COEFF 20%
e f
PUMP SPEED Time ClkTime UF R Curr
02:00 12:30 1.5 0.9
PROFILE UF COND
WARNING
graph.
The red curve on the graph represents the configured UFR Profile while the yellow
curve represents the achieved UFR values.
Entering the PROFILE\UF view a green cursor is positioned on the current UFR value.
the position of the green cursor on the UF Profile graph.
Note
To prevent problems in the Profile graph visualization, do not press simultaneously the
two Function Bar Arrows.
Note
graph.
Rev. B
The clock time (ClkTime)
The UF rate programmed value (UF R)
The UF rate current value (Curr) for the point in time at which the green cursor is
positioned on the graph (Time).
By pressing the SET button, a view is displayed where the profile attributes can be
modified.
Rev. B
COND Profile
When selecting PROFILE\Cond, the following view appears. Both the configured
Conductivity Profile and the achieved Conductivity values are displayed in the
Parameter Area. An example of a Progressive Conductivity Profile is displayed:
12:30
-- / --
--- / ---mmHg
--- pu/min
mS/cm CONDUCTIVITY
17.0
16.0
15.0
14.0
13.0
VEN ART 0:00 1:00 2:00 3:00 4:00
Time h:min
BLOOD FLOW
CON CURVE TYPE PROGRESSIVE INITIAL VALUE 16.7 mS/cm
Plasma Conduct. 13.5 mS/cm FINAL VALUE 14.4 mS/cm
Ionic Mass Bal nmol CURVE COEFF 25%
e f
PUMP SPEED Time ClkTime Cond Curr
02:00 12:30 14.0 14.5
PROFILE UF COND
WARNING
graph.
The red curve on the graph represents the configured Conductivity Profile while the
yellow curve represents the achieved Conductivity values.
Entering the PROFILE\Cond view a green cursor is positioned on the current
Conductivity value.
the position of the green cursor on the Conductivity Profile graph.
Note
Note
graph.
Rev. B
The Conductivity programmed value (Cond)
The Conductivity current value (Curr) for the point in time at which the green
cursor is positioned on the graph (Time).
The Plasma Conduct and Ionic Mass Bal values are displayed only if the
DiascanTMMonitoring System is active and a Clearance measurement has been taken.
(See Section 5.E Monitoring, in this manual, for a detailed description of these
parameters).
By pressing the SET button, a view where the profile attributes can be modified is
accessed.
Rev. B
5.D.3.7.2 Modification of a Curve during DIALYSIS
Progressive Curve shapes
When a change in a Progressive Curve is required during DIALYSIS, the INITIAL

VALUE represents the first changeable point on the Profile after the current actual
value, i.e. at the next the 5 minute point.
Thus the modification will only affect the remaining portion of the Profile.
No modifications in a Progressive Curve are allowed in the last 15 min. of DIALYSIS.
Step curve
When a change in a Step Curve is required during DIALYSIS, the first changeable Step
on the Profile is the Step after the current Step, i.e. the next 15 minute Step.
Thus the modification will only affect the remaining portion of the Profile.
No modifications in a Step Curve are allowed in the last Step of DIALYSIS.
5.D.3.7.3 Profile during WASHBACK
WASHBACK may be carried out without discontinuing Profiling.
Rev. B
5.D.3.8 Deactivation of Profiling
Deactivation by Operator request
To deactivate PROFILE for a parameter, the PROFILE view must be accessed. Then
press the ACTIVATION UF RATE CURVE and/or the ACTIVATION CONDUCT.
CURVE Action key to deactivate the profile; a superimposed window will appear:
Confirm last action made.

Use -/+ button to modify UF R
Press CONFIRM to discontinue
UF Profiling.
Or
Confirm last action made.

Use -/+ button to modify Conductivity.
Press CONFIRM to discontinue
Conductivity Profiling.
The UF R/Cond value must be confirmed. The UF R/Cond value that was confirmed
in the superimposed window will remain at that value for the reminder of the
treatment.
If PROFILE is deactivated after the DIALYSIS Action key selection, it is not possible to
re-activate it for the current dialysis treatment.
Deactivation at the end of DIALYSIS
When the machine reaches the end of the treatment, PROFILE is automatically
deactivated and cannot be re-activated.
Deactivation requested by the Protection System
During DIALYSIS, the Protection System continuously checks the accuracy of the
activated profiles, relative to the current value and the timing. If any problems are
detected, the ! Conductivity Profile #210 alarm or/and the ! ULTRAFILTRATION
RATE PROFILE #212 alarm is/are displayed and the machine automatically
deactivates the erroneous profile or profiles. Profile deactivated cannot be re-activated
for the current dialysis treatment.
Rev. B
SECTION 5.E - MONITORING 5.E-1
5.E MONITORING
5.E SECTION 5.E - MONITORING
5.E.1 DIASCAN Monitoring System

5.E.1.1 General
The DIASCAN Monitoring System allows real time, non-invasive and automatic
monitoring of patients and dialyser parameters that can be computed from
conductivity measurements on the dialysate side.
The clinical purpose of this monitoring is to provide a measure of dialysis efficacy for
quality control purposes.
The basic principle of this monitoring system is to periodically measure, during the
dialysis treatment, the dialysate conductivity at the hemodialyser outlet, following an
adjustment of the inlet dialysate conductivity. During the measurement, the inlet
conductivity is automatically adjusted by 1.0 mS/cm for 2 minutes. As a result of this
increment in conductivity, a mathematical model computes several parameters
relevant to the dialysis process:
The IONIC CLEARANCE: Average Clearance of ionized substances; this value is

strongly correlated to Urea Clearance. This is a relevant parameter of the clearance
actually obtained from the patient, since it includes effects of fistula recirculation
and ultrafiltration rate on solute removal during dialysis.
The Plasma Conduct: An expression of the effective plasma ionic concentration.

This is a factor that governs the intra/extra cellular fluid shifts. (The Plasma Conduct
value is displayed in the PROFILE\Cond view if the DIASCAN USE parameter is set
to YES).
Three other parameters are derived from the IONIC CLEARANCE:
1) The Depurated Vol: The volume of body water completely cleared of solute
during the treatment, with reference to small molecular weight solutes. The
computation is based on repeated Clearance measures and on the assessment of
the effective dialysis time. This parameter allows the clinician to determine if the
prescribed dialysis dose (which is influenced by different factors such as dialysate
flow and blood flow, type of dialyser and time) has been achieved.
2) The KT/V: This value is computed by dividing the Depurated Vol by the Volume of
Distribution (DISTRIB VOLUME), which is to be established by the clinician,
according to the patients dry weight and the ratio of the Total Body Water to
Patient Weight. This parameter allows the clinician to understand if the dialysis
dose that has been achieved is adequate for the patient.
3) The Ionic Mass Bal: This estimation is based on the continuous dialysate outlet
conductivity measurement, for each patient. It correlates to the sodium mass
balance. (The Ionic Mass Bal value is displayed in the PROFILE\Cond view if the
DIASCAN USE parameter is set to YES).
Rev. B
5.E-2 PHOENIX OPERATOR MANUAL
WARNING
DIASCAN is automatically disabled if:
Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the
operator
Or
Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator
Or
The patient connection is performed before the completion of the initial auto-
calibration.
Or
A Fast Recovery of the Dialysis process is performed
In such cases DIASCAN is inactivated (OFF) for the remainder of the treatment.
WARNING
DIASCAN measurements are not performed if the blood flow is 80 ml/min.
WARNING
For this software version, the accuracy of the DIASCAN Monitoring System is not
guaranteed in the SINGLE NEEDLE mode.
WARNING
The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB
VOLUME, which must be entered and confirmed by the operator. It is the
operators responsibility to assess the clinical validity of these parameters.
WARNING
The physician is responsible for the clinical adequancy of the parameters set for the
correct dialysis dose, based upon the Diascan measurements. Do not use a single
Diascan measurement as the only source of clinical information to initiate
therapeutic or pharmacologic actions (e.g. change in blood flow rate, dialysate flow
rate, dialyser, treatment time, etc...), as unstable operating conditions during a
single DIASCAN measurement may result in an artefact in the values computed
from the individual reading. Therefore, any changes in the dialysis prescription
made on the basis of Diascan analysis should be made in consideration of at least
two consecutive readings.
Rev. B
DIASCAN Characteristics
IONIC PLASMA IONIC MASS DEPURATED KT/V

CLEARANCE CONDUCT BAL VOL
Range of 50 - 300 13 - 17 mS/cm -500 - 800 0 - 200 0-3
Measure ml/min mmol(o) liters
Accuracy 7 ml/min 0.2 mS/cm - 2 liters (oo) -
(Std. Err.)
Resolution 1 ml/min 0.01 1mmol 0.1 liters 0.01
mS/cm
(o)
Positive values correspond to solutes removed from the patient.
(oo)
Accuracy Standard Error for a 4 hour dialysis.
Rev. B
5.E.1.2 Parameters
Selectable Parameters
Unit Incr. Max. Min. Default
DIASCAN USE - - YES NO NO
DIASCAN - - YES NO NO
CLEARANCE ALA. - - YES NO NO
CLEARANCE LEVEL ml/min 5 300 50 150
DRY WEIGHT Kg 0.5 200 8 60
DISTRIB VOLUME % 1 80 20 55
INTERMEASUREM h:min 0:15 1:00 0:00 0:30
TARGET KT l 1 200 0 40
TARGET KT/V - 0.05 3.00 0 1.30
TARGET Kt/V THRESH % 5 100 0 0
TARGET Kt/V Reached - - YES NO NO
DIASCAN USE
Set the DIASCAN USE parameter to YES to enable the DIASCAN device. This
parameter must be set to YES to utilize DIASCAN. In the IDLE mode, press the
Config\Machine\Accessories Navigation keys. Enter the SET Mode and select the
DIASCAN USE Parameter Box on the Touch Screen. Then select either the YES or
NO Parameter Box and press the CONFIRM button.
DIASCAN
Select the DIASCAN parameter to turn the DIASCAN function OFF or ON. It can be
set by pressing:
The Config\KT/V Navigation keys, in Standard Dialysis.
Or the Rx Config Navigation keys, then selecting one of the seven personalised
dialysis sessions (Patient/RX Action keys), in Patient dialysis, and entering in the Rx
Config\kT/V view.
The DIASCAN function may be turned OFF also after the start of the treatment in SET
Mode.
When the DIASCAN parameter is set to YES, the following parameters can be set:
CLEARANCE ALA.
This alarm may be programmed ON or OFF. If the CLEARANCE ALA parameter is
turned ON, an alarm is triggered if the IONIC CLEARANCE falls below the value set
for the CLEARANCE LEVEL parameter. The default setting for the CLEARANCE ALA. is
NO.
Rev. B
CLEARANCE LEVEL
The CLEARANCE LEVEL parameter may be SET to a value between 50 ml/min to 300
ml/min. If the computed Clearance falls below this value, and if the CLEARANCE ALA.
parameter is SET to YES, a CLEARANCE ALA. will occur. The default value for
CLEARANCE LEVEL is 150 ml/min.
DRY WEIGHT
The DRY WEIGHT value is used in the calculation of KT/V. This value is entered by
the clinician within a range of 8 kg to 200 kg. The default value for DRY WEIGHT is
60 kg.
DISTRIB VOLUME (Volume of Distribution)

The DISTRIB VOLUME value is used in the calculation of KT/V. The value is entered
by the clinician as a percentage of the patients DRY WEIGHT. The input range for
DISTRIB VOLUME is from 20% to 80%.
The default value is 55.
INTERMEASUREM
The INTERMEASUREM value defines the time interval between two DIASCAN
measurements. Possible SET values are:
0:00 No automatic measurements are triggered (manual mode)
0:15 A measurement is performed every 15 minutes (if Profiling mode is set to
NO)
0:30 A measurement is performed every 30 minutes
0:45 A measurement is performed every 45 minutes (if Profiling mode is set to
NO)
1:00 A measurement is performed once an hour.
The default value is 0:30
TARGET KT
The TARGET KT value defines the volume of body water to be purified during
DIALYSIS. The TARGET KT parameter is available only if the DIASCAN parameter is
set to YES.
It may be SET to a value between 0 l to 200 l
When the FORECAST kT, estimated by the machine, is lower than a percentage of the
TARGET KT value, the Forecast Dial. dose not match Prescrip.#354 alarm will
occur informing the operator that the FORECAST kT will not meet the prescribed
Kt.
The TARGET Kt/V THRESH may be set to enable the occurrence of the Forecast
Dial. dose not match Prescrip.#354 alarm by entering the expected percentage of
TARGET KT in the TARGET Kt/V THRESH parameter box.
Once the Depurated Volume is greater than or equal to a percentage of the TARGET
KT value and the TARGET Kt/V Reached parameter is set to YES, the Kt-Kt/V Target
Achieved#355 alarm will occur.
The TARGET KT/V THRESH may be set to enable the occurrence of the Kt-Kt/V
Target Achieved#355 alarm by entering the minimum accettable percentage of
The TARGET KT value has to be confirmed/entered to allow the Kt-Kt/V Target
Achieved#355 alarm occurrence.
The default value for TARGET KT is 40 l.
Rev. B
TARGET Kt/V
The TARGET KT/V value defines the Dialysis Dose to be achieved during
DIALYSIS. The TARGET KT/V parameter is available only if the DIASCAN parameter
is set to YES. It may be SET to a value between 0 to 3.00. The TARGET KT/V
parameter box will appear after the DRY WEIGHT and DISTRIB VOLUME have been
entered and confirmed for the treatment.
When the FORECAST kT/V, estimated by the machine, is less than a percentage of
the TARGET KT/V value, the Forecast Dial. dose not match Prescrip.#354 alarm
will occur informing the operator that the FORECAST kT/V will not match the
prescribed Kt/V.
The TARGET KT/V THRESH may be set to enable the occurrence of the Forecast
Dial. dose not match Prescrip..#354 alarm by entering the expected percentage of
Once the KT/V is greater than or equal to the set percentage of the TARGET KT/V
value and the TARGET Kt/V Reached parameter is set to YES, the Kt-Kt/V Target
Achieved#355 alarm will occur.
The TARGET Kt/V THRESH may be set to enable the occurrence of the Kt-Kt/V
Target Achieved#355 alarm by entering the minimum accettable percentage of
The TARGET KT/V value has to be confirmed/entered to allow the Kt-Kt/V
Target Achieved#355 alarm occurrence.
The default value for TARGET KT/V is 1.30.
TARGET Kt/V THRESH

The TARGET Kt/V THRESH parameter is available only if the DIASCAN parameter is
set to YES. It may be set to a value between 0 to 100%.
This value is set to activate the Forecast Dial. dose not match Prescrip.#354
alarm.
The default value for TARGET Kt/V THRESH is 0%.
TARGET Kt/V Reached

The Kt-Kt/V Target Achieved#355 alarm may be programmed ON or OFF.
When the TARGET Kt/V Reached parameter is set to YES, the #355 alarm is triggered
once the alarm conditions for this alarm occurrence are reached.
The default value for TARGET Kt/V Reached parameter is NO.
Note
DIASCAN can be de-activated at any time, for the current dialysis treatment, by pressing
the kT/V Navigation key. Enter the SET Mode and select the DIASCAN Parameter Box on
the Touch Screen, then select NO and press the Confirm button.
If the DIASCAN Parameter is set to NO, it is not possible to activate DIASCAN again after
Dialysate Preparation is complete.
Note
The KT/V value will be displayed only if a valid number for DISTRIB VOLUME is present
and the DRY WEIGHT of the patient has been confirmed.
Note
If the INTERMEASUREM parameter is set to 0:15, 0:30, 0:45 or 1:00, no additional
manual measurements are allowed.
Rev. B
5.E.1.3 Initial Auto-Calibration

At the beginning of each treatment, at the end of the conductivity T1 TEST phase,
DIASCAN Monitoring System starts an Auto-Calibration Process, which is indicated
by a flashing DIASCAN icon. The goal of this Auto-Calibration is to verify the
proper functioning of the conductivity measuring system.
The initial Auto-Calibration consists of measuring the outlet conductivity at two

different conductivity set points: 14 mS/cm and 16 mS/cm.
During Auto-Calibration, the conductivity is increased, first, to 14 mS/cm for 90
seconds (on average) and then is increased to 16 mS/cm again for 90 seconds to
complete Diascan autocalibration.
The Auto-Calibration Process is signaled by the DIASCAN icon flashing and by the
message DIASCAN Autocalibration in Progress... displayed on the screen together
with a progress bar informing that the DIASCAN autocalibration is in progress.
Note
If you disable Diascan during the Auto Calibration procedure, the Diascan Initial
Calibration Failed #244 alarm may occur. In this case, switch OFF the machine, wait 5
seconds, then switch ON the machine again.
At the end the Auto-Calibration, two results are possible:
If the alignment is completed successfully, the DIASCAN icon stops flashing and
the DIASCAN Monitoring System is ready for use.
If the alignment cannot be properly completed, the DIASCAN icon becomes

dotted and the message "Diascan Initial Calibration Failed" will be displayed.
This message can be canceled by pressing the OVERRIDE button.
In case of a failure of the Auto-Calibration, disable the DIASCAN Monitoring System

by pressing kT/V Navigation key. Enter the SET Mode. Select the DIASCAN
Parameter Box on the Touch Screen. Then select NO and press the CONFIRM
button.
Note
The initial Auto-Calibration Procedure is only required to verify the correct functioning of
the DIASCAN Monitoring System. Failure of the procedure does not affect the dialysis
treatment.
Note
If the Diascan Initial Calibration Failed #244 alarm occurs frequently during the initial
Auto-Calibration Procedure, call for Service.
Note
Following selection of a NEW SESSION Action key, an initial Auto-Calibration Procedure
is not repeated. An Auto-Calibration Procedure will only be performed after the NEW
SESSION Action Key is selected if the Auto-Calibration failed during the previous dialysis
session.
Note
If the Patient Sensor detects BLOOD prior to the end of the Auto-Calibration Procedure,
the DIASCAN Monitoring System is automatically disabled and its icon becomes dotted.
Rev. B
5.E.1.4 MEASUREMENTS
The measurement of Plasma Conduct and IONIC CLEARANCE is automatically
triggered at the frequency selected in the INTERMEASUREM parameter. During the
entire time of the measurement (about 7 min), the final conductivity is controlled by
the DIASCAN Monitoring System and the user is not allowed to change the
conductivity. This measurement phase is indicated by a flashing DIASCAN icon.
Note
In order to ensure that DIASCAN functions correctly, increases in conductivity of
greater than 2 mS/cm should be avoided, both in Manual and PROFILE mode.
Note
The DIASCAN measurement will fail if there are any modifications to either of the
following parameters during the measuring period:
blood flow rate
dialysate flow rate
To ensure an accurate measurement it is recommended that modifications in these
parameters are not performed within 2 minutes of the next DIASCAN measurement.
Note
A DIASCAN measurement will also be interrupted by any manual or automatic bypass
condition, such as the BYPASS or UF ONLY key, or the occurrence of an alarm that
causes the machine to go into BYPASS.
Note
The user can stop a measurement in progress or switch OFF the DIASCAN Monitoring
System at any time without any consequence to the dialysis treatment.
Note
If DIASCAN is switched OFF in the Config view or in the Rx Config view, the DIASCAN
view in the kT/V menu (selected by pressing kT/V Navigation key) will disappear. If
DIASCAN is switched OFF in the DIASCAN view (selected by pressing kT/V and then
the Set button) this will cause the DIASCAN icon to disappear, and measurements will
not be executed.
Rev. B
Problem Possible cause/solution

A manual measurement was requested Proper conditions for a measurement do not
but the icon did not start to flash. exist. Verify that the set-values for blood and
dialysate flow rates are within the operating
range for the DIASCAN and wait for the
correct hydraulic condition.
The icon is dotted. DIASCAN failed the initial auto-calibration.
Clean the DIASCAN probe by performing a
Descaling procedure.
The dialysate flow rate is set to a value
outside of the proper operating range. Set
the dialysate flow rate to a correct value.
All the DIASCAN parameters in the kT/V No measurements have been performed.
view are ---. Perform at least one manual measurement or
wait for the first automatic measurement.
No values have been inserted/confirmed for
the parameters DRY WEIGHT and DISTRIB
VOLUME.
Insert/confirm a value for DRY WEIGHT and
DISTRIB VOLUME.
DIASCAN parameters are not displayed in If noticed before starting treatment, when
SET view even if the Diascan function is these parameters may have to be modified,
enabled (DIASCAN parameter set to YES switch OFF the machine, wait 5 seconds and
in CONFIG). switch ON the machine.
Rev. B
5.E.1.5 Operator Interface

DIASCAN Icons
If the DIASCAN parameter is set to YES, an icon will appear on the Touch Screen. The
possible icons relating to the DIASCAN Monitoring System are listed below:
DIASCAN active (IDLE)

DIASCAN calibrated (TREATMENT)
DIASCAN present but Auto-Calibration failed
Note
The DIASCAN active icon flashes during both the initial Auto-Calibration and every
measurement.
KT/V MENU
In TREATMENT, both during the Standard dialysis and during the Patient/RX dialysis,
when the Kt/V Navigation key is selected, the main view of the Kt/V environment is
entered.
By pressing the Kt/V Navigation keys it is possible to see the Clearance graph.
12:30
-- / --
--- / ---mmHg
--- pu/min
DIASCAN MEAS
STOP MEASURE
VEN ART
BLOOD FLOW
DEPURATED VOL6.1 L KT/V 0.14
FORECAST KT 26 L FORECAST KT/V 1.2
TARGET KT 150 l TARGET KT/V 2.00
e f
BLOOD FLOW Time ClkTime Thres Kurea B Flow
KT/V
Rev. B
Note
After confirming the DISTRIB VOLUME and DRY WEIGHT parameter values, the TARGET
KT parameter disappears and the TARGET KT/V, KT/V and FORECAST kT/V parameters
becomes available in the kT/V view.
If the INTERMEASUREM parameter is set to 0:00, the DIASCAN MEAS Action key is
present and allows the manual initiation of a DIASCAN measurement.
During every measurement, the STOP MEASURE Action key is present to allow an
interruption of the DIASCAN measurement.
Note
If the INTERMEASUREM parameter is set to 0:15, 0:30, 0:45 or 1:00 the DIASCAN MEAS
Action key is not available.
From the kT/V view is possible to see:

The graph of the CLEARANCE measurements (YELLOW line).
The graph of the B Flow (blood flow value) (BLUE line).
The graph of the CLEARANCE LEVEL alarm threshold (RED line). If the
CLEARANCE ALA. parameter is set to YES, so the alarm threshold is active, a
DIASCAN: LIMIT LOW CLEARANCE #249 alarm occurs when the Clearance
value falls below this threshold.
The CLEARANCE ALA. parameter can be activated (set to YES) or deactivated (set
to NO) for the dialysis treatment; when it is deactivated, the graph of the
CLEARANCE LEVEL alarm threshold is shown as a RED line on the Time line
(CLEARANCE LEVEL low limit line).
Entering the kT/V view a green cursor is positioned on the last DIASCAN
measurement.
the position of the green cursor on the Clearance graph, in correspondence to the
DIASCAN measurements.
Note
To prevent problems in the Clearance graph visualization, do not press simultaneously the
two Function Bar Arrows.
Note
graph.
The CLEARANCE LEVEL alarm threshold (Thres)
The Clearance value (Kurea)
The blood flow value (B Flow)
The Time value is calculated starting from the DIALYSIS Action key selection.
Rev. B
In the kT/V view the following values related to the last DIASCAN measurement, are
also displayed:
Depurated Vol.
FORECAST: The volume of body water completely cleared of solute during the
treatment, estimated on the current Clearance value and the DIALYSIS TIME set.
TARGET KT: The volume of body water to be purified during the treatment.
KT/V.
FORECAST kT/V: calculated with the following formula:
FORECAST Kt
FORECAST Kt/V =
DISTRIB VOLUME DRY WEIGHT
TARGET KT/V: Dialysis Dose to be achieved during the treatment.
Note
The KT/V, TARGET KT/V and the FORECAST kT/V values are not displayed if the DISTRIB
VOLUME and DRY WEIGHT parameters are not confirmed in Set Mode.
After pressing the Set button the following view is displayed, where all the DIASCAN
relevant parameters may be set:
12:30
DIASCAN CLEARANCE ALA. CLEARANCE DRY WEIGHT

LEVEL
DISTRIB VOLUME INTERMEASUREM
TARGET KT TARGET Kt/V TARGET KT/V

THRESH
KT/V
Note
If confirming the DISTRIB VOLUME and DRY WEIGHT parameter values, the TARGET KT
parameter disappears and the TARGET KT/V parameter becomes available.
Rev. B
SECTION 5.F - CLEAN DIALYSATE SYSTEM 5.F-1
5.F CLEAN DIALYSATE

5.F SECTION 5.F - CLEAN DIALYSATE System
5.F.1 General
The purpose of the Clean Dialysate System is to purify the dialysate before its use in
the dialyser. The patients risk of exposure to bacteria and endotoxin can thereby be
minimized.
The Clean Dialysate System has been expressly designed to be used with the
DIACLEAR Ultrafilter.
If any defects in the Ultrafilter are detected, an alarm occurs.
Note
It is recommended that the Ultrafilter is replaced following the maximum dialysis session
directions provided in the DIACLEAR Instructions for Use.
Note
If the machine is stored for more than a week, replace the DIACLEAR Ultrafilter before
using the Clean Dialysate feature again.
Note
When the DIACLEAR Ultrafilter is used, the temperature in the dialyser may be 0.3 - 0.5C
lower than the displayed temperature.
WARNING
When the Ultrafilter has been installed, an ADR: RINSING must be performed.
Rev. B
5.F-2 PHOENIX OPERATOR MANUAL
5.F.2 Ultrafilter information
CAUTION
This information must be read before the use of the DIACLEAR Ultrafilter.
Operational warnings and cautions appear in the appropriate sections of the text to
help ensure a safe and effective treatment.
INDICATIONS
Bacterial contamination of dialysate has frequently been observed and may induce
fever and inflammatory reactions in dialysis patients.
Ultrafiltration with the DIACLEAR Ultrafilter is indicated for purification of dialysate to
obtain microbiologically high quality dialysate. The risk of exposure to bacteria and
endotoxin may therefore be minimized.
SPECIFICATIONS
For the Ultrafilter specifications, physical characteristics, materials, performance and
limits of use, refer to the DIACLEAR Instructions for Use.
RECOMMENDATIONS
WARNING
For the disinfection of the Ultrafilter it is mandatory to use only the chemical
agents recommended in the DIACLEAR Instructions for Use. They are also
compatible with the PHOENIX Haemodialysis System. The maximum
concentration allowed for the disinfectant used is:
6% Sodium Hypochlorite
4% Peracetic acid
40% Formaldehyde
100% Instrunet
100% Steridial
Some solvents and other chemical products used for cleaning can damage the
DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of
prohibited products.
ADVERSE REACTIONS
Rev. B
5.F.2.1 DIACLEAR Instruction for Use
CAUTION
Make certain that the procedures outlined in this Operator Manual are carefully
reviewed before the DIACLEAR Ultrafilter is used on a PHOENIX Haemodialysis
System that is equipped with the Clean Dialysate feature.
Aseptic technique must be employed when installing the DIACLEAR Ultrafilter to

avoid contamination of the fluid pathway.
Prime the DIACLEAR Ultrafilter following the Instructions for Use described below, to
ensure that the system is completely purged of air.
Introduction of air into the DIACLEAR during its use may cause an increased pressure
drop and subsequent alarms on the PHOENIX machine.
Should the physician in charge decide to use the DIACLEAR for multiple uses, it is
imperative to use a chemical disinfectant that is recommended in the DIACLEAR
Instructions for Use and that is also compatible with the PHOENIX machine.
The instructions supplied by the manufacturer for the chemical disinfectant must be
strictly followed. The microbiological quality of the system must be validated by the
dialysis facility in order to demonstrate that the disinfection process is effective.
Conditions of disinfection and rinsing after the first use are the responsibility of the
prescribing physician.
PROCEDURES
This section describes the use of the DIACLEAR Ultrafilter when installed on a
PHOENIX machine, equipped with the Clean Dialysate feature.
Rev. B
5.F.3 Installation of the DIACLEAR Ultrafilter on a machine

equipped with the Ultrafilter Bypass connector
WARNING
IDLE view.
Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING to
prime the DIACLEAR.
Note
Before installing the DIACLEAR Ultrafilter, verify that a Rinsing has been performed as
latest process in order to avoid the presence of chemical residues in the lines.
Setup Instructions
Before installing the DIACLEAR Ultrafilter, ensure that the ULTRAFIL. USE parameter is
set to YES in Config/MACHINE/OPTION view.
Switch Off the machine.
Identify the Ultrafilter Bypass connector version present on the machine. Refer to the
figure below to identify the Old or the New version.
Old version New version
If the machine is provided with the old version of the Ultrafilter Bypass connector: refer
to the 5.F.3.1 Removal of the Ultrafilter Bypass connector (old version) paragraph,
then proceed with the installation of the DIACLEAR Ultrafilter as described in the
5.F.3.2 Installation of the DIACLEAR Ultrafilter paragraph.
If the machine is provided with the new version of the Ultrafilter Bypass connector:
refer to the Appendix C, C.1 Disconnection of the three Ultrafilter Bypass connector
lines section then proceed with the installation of the DIACLEAR Ultrafilter as
described in the 5.F.3.2 Installation of the DIACLEAR Ultrafilter paragraph.
Rev. B
5.F.3.1 Removal of the Ultrafilter Bypass connector (old version)

Before disconnecting the three Ultrafilter Bypass connector lines, clamp them
in order to prevent any possible spillage of water (see Fig. 1).
Fig. 1
Rev. B
Disconnection of the Deaeration Line (line connected to the upper Ultrafilter Bypass
connector port)
Disconnect the Deaeration Line (see Fig. 2) from the upper Ultrafilter Bypass
connector port by unscrewing the Luer lock from the threaded locking nut (turn
the Luer lock counter clockwise while holding the threaded locking nut in place).
Deaeration
Line
Luer lock
Threaded
locking nut
Fig. 2
Disconnection of the Filtrate Outlet Line (line connected to the middle Ultrafilter
Bypass connector port)
Press the Filtrate Outlet Lines pinch safety clip springs (see Fig. 3) then unhook the
Filtrate Outlet Line pinch safety clip from the middle Ultrafilter Bypass connector
port, keeping firmly the Ultrafilter Bypass connector.
Pinch safety
clip springs
Fig. 3
Rev. B
Disconnect the Filtrate Outlet Line from the middle Bypass connector port (see Fig.
4).
Filtrate
Outlet
Line
Fig. 4
Disconnection of the Dialysate Inlet Line (line connected to the lower Ultrafilter Bypass
connector port)
Disconnect the Dialysate Inlet Line (see Fig. 5) from the lower Ultrafilter Bypass
connector port by unscrewing the Luer lock from the threaded locking nut (turn
the Luer lock counter clockwise while holding the threaded locking nut in place).
Threaded
locking nut
Luer lock
Dialysate
Inlet Line
Fig. 5
Removal of the Ultrafilter Bypass connector

Remove the Ultrafilter Bypass connector from its holder and store it for a further
use.
Rev. B
5.F.3.2 Installation of the DIACLEAR Ultrafilter
WARNING
The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in
the IDLE view.
Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING
cycle to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or
a DIALYSIS phase.
Installation of the DIACLEAR Ultrafilter

Remove the DIACLEAR Ultrafilter from the package.
Place the DIACLEAR Ultrafilter in the two fixing clips present on the machine upper rear
panel (the blue cap must be upwards).
Remove the three caps (without throwing them away) from the DIACLEAR Ultrafilter
ports corresponding to the Deaeration Outlet Port, to the Filtrate Outlet Port and to the
Dialysate Inlet Port (see Fig. 1).
Deaeration
Filtrate Outlet Outlet Port
Port
Dialysate
Inlet Port
Fig. 1
Note
Do not throw the three DIACLEAR Ultrafilter caps away, because they will be used during the
removal of the DIACLEAR Ultrafilter, as described in the 5.F.4.1 Removal of the DIACLEAR
Ultrafilter paragraph.
Rev. B
Connection of the Deaeration Line

Insert the Deaeration Lines Luer lock into the Deaeration Outlet Port.
Screw all the way the Deaeration Lines Luer lock to the Deaeration Outlet Port of
the DIACLEAR Ultrafilter.
Ensure that the Deaeration Line is not twisted or kinked (see Fig. 2).
Luer lock
Deaeration
Line
Fig. 2
Connection of the Filtrate Outlet Line

Spray the Filtrate Outlet Port of the DIACLEAR Ultrafilter with Ethyl Alcohol.
Fully insert the Filtrate Outlet Line into the Filtrate Outlet Port.
Hook the Filtrate Outlet Line pinch safety clip to the Filtrate Outlet Port (see Fig. 3).
Pinch safety
clip
Filtrate Outlet
Line
Fig. 3
Rev. B
Connection of the Dialysate Inlet Line

Insert the Dialysate Inlet Lines Luer lock into the Dialysate Inlet Port.
Screw all the way the Dialysate Inlet Lines Luer lock to the Dialysate Inlet Port of the
DIACLEAR Ultrafilter.
Ensure that the Dialysate Inlet Line is not twisted or kinked (see Fig. 4).
Dialysate
Inlet Line
Luer lock
Fig. 4
Ultrafilter After Ultrafilter lines connection, remove the clamps from the three
DIACLEAR Ultrafilter lines, if they have been clamped (see Fig. 5).
Fig. 5
Perform a Rinsing procedure to prime the DIACLEAR Ultrafilter.
Rev. B
5.F.4 Installation of the Ultrafilter Bypass connector on a

machine equipped with the DIACLEAR Ultrafilter.
WARNING
The Ultrafilter Bypass connector MUST be installed when the PHOENIX machine is
in the IDLE view.
When an Ultrafilter Bypass connector has been installed, it is mandatory to
perform a disinfection cycle, before entering a DIALYSIS phase.
Note
It is recommended to replace the DIACLEAR Ultrafilter following the dialysis session
directions provided in the DIACLEAR Ultrafilter Instructions for Use.
WARNING
The following operations must be performed when the machine is in the IDLE
view.
5.F.4.1 Removal of the DIACLEAR Ultrafilter

Before installing the Ultrafilter Bypass Connector, ensure that the ULTRAFIL. USE
parameter is set to NO in Config/MACHINE/OPTION view.
Before disconnecting the Ultrafilter lines, clamp the Deaeration Line, the Filtrate Outlet Line and
the Dialysate Inlet Line connected to the DIACLEAR Ultrafilter, in order to prevent any spillage
of water.
Follow the instructions below to disconnect the three Ultrafilter lines:

Disconnection of the Deaeration Line
Disconnect the Deaeration Line from the DIACLEAR Ultrafilter Deaeration Outlet Port,
by unscrewing the Deaeration Lines Luer lock from the DIACLEAR Ultrafilter
Deaeration Outlet Port.
Close the DIACLEAR Ultrafilter Deaeration Outlet Port by capping it.
Disconnection of the Filtrate Oulet Line

Press the Filtrate Outlet Line pinch safety clip springs then unhook the pinch safety clip
from the DIACLEAR Ultrafilter Filtrate Outlet Port.
Disconnect the Filtrate Outlet Line from the DIACLEAR Ultrafilter Filtrate Outlet Port.
Close the DIACLEAR Ultrafilter Filtrate Outlet Port by capping it.
Disconnection of the Dialysate Inlet Line

Disconnect the Dialysate Inlet Line from the DIACLEAR Ultrafilter Dialysate inlet port,
by unscrewing the Dialysate Inlet Lines Luer lock from the DIACLEAR Ultrafilter
Dialysate Inlet Port.
Close the DIACLEAR Ultrafilter Dialysate Inlet Port by capping it.
Rev. B
Removal of the DIACLEAR Ultrafilter and Ultrafilter Bypass connector installation

Remove the DIACLEAR Ultrafilter from its holder and throw it away.
Identify the Ultrafilter Bypass connector version to be installed on the machine. Refer
to the figure below to identify the Old or the New version.
Old version New version
If the old version of the Ultrafilter Bypass connector has to be installed: refer to the
5.F.4.2 Installation of the Ultrafilter Bypass connector (old version) paragraph for the
installation of the old version of the Ultrafilter Bypass connector.
If the new version of the Ultrafilter Bypass connector has to be installed: refer to the
Appendix C, C. 2 Connection of the Ultrafilter Bypass connector section for the
installation of the new version of the Ultrafilter Bypass connector.
Rev. B
5.F.4.2 Installation of the Ultrafilter Bypass connector (old version)
Follow the instructions below to connect the three Ultrafilter lines to the Ultrafilter Bypass
connector.
Connection of the Deaeration Line

Insert the Deaeration Lines Luer lock into the upper Ultrafilter Bypass connector
port (the Ultrafilter Bypass connector is symmetric, therefore the upper and lower
ports are equivalent).
Fix the Deaeration Lines Luer lock by rotating clockwise the threaded locking nut
onto it (see Fig. 1).
Deaeration
Line
Threaded
locking nut
Fig.1
Rev. B
Connection of the Dialysate Inlet Line

Insert the Dialysate Inlet Lines Luer lock into the lower Ultrafilter Bypass connector
port.
Fix the Dialysate Inlet Lines Luer lock by rotating clockwise the threaded locking
nut onto it (see Fig. 2).
Threaded
locking nut
Dialysate
Inlet Line
Fig. 2
Connection of the Filtrate Outlet Line

Spray the middle Ultrafilter Bypass connector port with Ethyl Alcohol.
Fully insert the Filtrate Outlet Line onto the middle Ultrafilter Bypass connector
port.
Hook the Filtrate Outlet Lines pinch safety clip to the middle Ultrafilter Bypass
connector port (see Fig. 3).
Filtrate
Outlet Line
Pinch safety
clip
Fig. 3
After having connected the Ultrafilter lines, insert the Ultrafilter Bypass connector
into the lower fixing clip present on the panel.
Rev. B
Remove the clamps from the three lines connected to the Ultrafilter Bypass
connector ports (see Fig. 4).
Fig. 4
Perform a disinfection cycle before starting a dialysis treatment.
Rev. B
5.F.5 Clean Dialysate
5.F.5.1 Priming/Rinsing of the DIACLEAR Ultrafilter

After its installation, the DIACLEAR Ultrafilter must be primed by performing an ADR:
RINSING cycle. Only after a Rinsing cycle the DIALYSIS treatment can be selected.
Note
Rinsing of the DIACLEAR Ultrafilter can only be carried out during an ADR: RINSING cycle of
the PHOENIX machine.
Check that the DIACLEAR Ultrafilter is correctly installed and make sure that the
ULTRAFIL. USE parameter is set to YES.
Select ADR: RINSING. Set the RINSING TIME parameter to, at least, 30 min.
In case of alarms during the RINSE cycle, check that the lines are not clamped.
If a line is clamped, unclamp it and perform again the prime (ADR: RINSING)
procedure of the DIACLEAR Ultrafilter.
WARNING
Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may
cause damage.
WARNING
The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be
performed aseptically, so that the fluid pathway is not contaminated. Perform a
DISINFECTION procedure before patient connection.
5.F.5.2 Dialysate Preparation, Priming/Rinsing of the dialyser and

performing the dialysis treatment
Before selecting DIALYSIS make sure that the DIACLEAR Ultrafilter has been
rinsed.
Refer to the Section 5 - Dialysis Operation for instructions on dialysate preparation.
Monitoring of the DIACLEAR Ultrafilter related pressures occurs while the PHOENIX
machine is operating so that problems may be detected.
The alarms, Ultrafilter Is Packed (#138) or Ultrafilter Max Pressure (#146) occur
when there is a high resistance on the dialysate side inside the DIACLEAR Ultrafilter.
To correct these conditions, reduce the dialysate flow to 350 ml/min to reduce the
pressure. This operation allows the dialysis treatment to be completed (it is necessary
to replace the DIACLEAR Ultrafilter at the end of dialysis) when either alarm occurs.
Note
The DIACLEAR Ultrafilter can be excluded from the circuit at any time by pushing the
BYPASS Action key or the UF ONLY Action key.
Rev. B
5.F.5.3 Changing the DIACLEAR Ultrafilter

Note
The changing of the DIACLEAR Ultrafilter must be performed following the directions
provided in the DIACLEAR Instructions for Use. A new DIACLEAR Ultrafilter must be
installed if a Ultrafilter Max Pressure alarm or a Ultrafilter Is Packed alarm occurs.
WARNING
The DIACLEAR Ultrafilter can only be changed when the Phoenix machine is in the
IDLE view.
WARNING
It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter
installation.
5.F.5.3.1 Installation of a new DIACLEAR Ultrafilter
For the installation of a new DIACLEAR Ultrafilter, see paragraph 5.F.3.2 Installation
of the DIACLEAR Ultrafilter in this section.
5.F.5.4 Resetting of the DIACLEAR Ultrafilter Installation

parameters
Both when installing a new DIACLEAR Ultrafilter and when replacing an used
DIACLEAR Ultrafilter, the DIACLEAR Ultrafilter installation parameters must be reset
by pressing the CHANGE CLEAN DIAL Action key in the MACHINE view, while the
machine is in Idle mode:
CHANGE CLEAN
DIAL
POWER DOWN COUNT
ABD DIAGNOSTIC
ULTRAF PRE
INSTALL TIME
TREATM NUMBER
MACHINE SERVICE STATUS RECORDE CALIBRAT

R ION
Rev. B
Note
The CHANGE CLEAN DIAL Action key is available only in Idle mode and if the ULTRAFIL.
USE parameter is set to YES in the Config view.
INSTALL TIME: This parameter totals the days elapsed from the installation of the
DIACLEAR Ultrafilter by the operator. After the selection of the CHANGE CLEAN
DIAL Action key, the value displayed for this parameter (related to the old DIACLEAR
Ultrafilter) is cleared and the machine restarts totalling the days elapsed from the
installation of the new DIACLEAR Ultrafilter.
TREATM NUMBER: This parameter totals the number of treatments in which the
DIACLEAR Ultrafilter has been used. After the selection of the CHANGE CLEAN
DIAL Action key, the value displayed for this parameter (related to the old
DIACLEAR Ultrafilter) is cleared and the machine restarts totalling the number of
treatments in which the new DIACLEAR Ultrafilter has been used.
WARNING:
The user is responsible for monitoring the DIACLEAR Ultrafilter working time, by
resetting the DIACLEAR Ultrafilter installation parameters each time a new
DIACLEAR Ultrafilter is installed/replaced, in order to replace the used DIACLEAR
Ultrafilter following the maximum dialysis session directions provided in the
DIACLEAR Instructions for Use.
5.F.5.5 Chemical Disinfection and Descaling
Refer to the PHOENIX Operators Manual, in Section 6 - Clean/Disinfect, for

Disinfection and the Descaling procedures.
Refer to the paragraph RECOMMENDATIONS in this section and refer to the

DIACLEAR Instructions for Use for the list of approved disinfection agents.
5.F.5.6 Heat/Heat Citric Disinfection
The compatibility of the DIACLEAR Ultrafilter membrane with PHOENIX processes

has been validated for both the Heat Disinfect Process and the Heat Citric Disinfect
Process.
Therefore, each disinfection process that can be executed by the PHOENIX can be
executed through the ultrafilter.
Rev. B
5.F.6 PHOENIX Operator Interface
5.F.6.1 Configuration
Parameters
Unit Incr. Max. Min. Default
ULTRAFIL. USE - - YES NO NO
ULTRAF PRES mmHg 10 200 20 100
ULTRAFIL. USE
This parameter is used to enable the Clean Dialysate System. The ULTRAFIL. USE
parameter must be set to YES in the Config/Machine view in order to allow the other
parameters to be displayed.
If there is an inconsistency between this parameter and the state of the DIACLEAR
Ultrafilter, an alarm will occur.
ULTRAF PRES
This parameter measures the difference between the filter inlet and outlet pressures in
the ultrafilter membrane during operating conditions. Therefore, in non-operating
conditions where fluid passes through the membrane, this parameter will be zero
since the pressure difference is not significant.
This parameter is set in the Config\Machine\Clean Dial. view. When the value set for
the parameter is exceeded a warning message appears.
Note
The value set for the ULTRAF PRES parameter must be in agreement with the value
suggested in the DIACLEAR Instructions for Use.
Note
The ULTRAF PRES parameter is displayed on the Machine view, but only if the ULTRAFIL.
USE in the Config view is set to YES.
Rev. B
5.F.6.2 Icons
If the ULTRAFIL. USE parameter in the Config view is set to YES, a related icon will
appear on the icon bar of the Touch Screen. The possible icons relating to the Clean
Dialysate process are listed below:
Ultrafilter preset and in use.

(Not currently available)
Ultrafilter absent or a Switches Error Alarm occurred when

ULTRAFIL. USE is set to YES
(Not currently available)
Rev. B
6 CLEAN/DISINFECT
6. SECTION 6 - CLEAN/DISINFECT
Overview
This section contains information about cleaning (internal and external) and
disinfection measures that should be performed on the PHOENIX Haemodialysis
Delivery System.
This information includes:
Description of the ADR (Automatic Disinfection, Rinsing) capabilities of the

PHOENIX Haemodialysis Delivery System.
Step-by-step instructions for performing each of the machines ADR procedures.
Procedure for cleaning the exterior of the PHOENIX machine and for inspection
and storage of the machine.
Requirements
1. Follow the manufacturers instructions when performing ADR procedures.
2. A post-dialyser dialysate sample should be cultured monthly for machine

bioburden levels, as per AAMI and CDC guidelines. Follow your facility protocol
for collecting and culturing the sample.
Note
At the machine installation a post-dialyser dialysate sample should be cultured for machine
bioburden levels, as per AAMI and CDC guidelines. Follow your facility protocol for
collecting and culturing the sample.
Internal Cleaning and Disinfection Protocol

The PHOENIX provides several methods of achieving disinfection of the hydraulic
pathway of the system. The choice of which of these methods to use is the
responsibility of the facility. The Manufacturer validates the methods suggested based
on in-vitro laboratory testing for adequate concentration or temperature distribution
to obtain microbial efficacy and hydraulic circuit material compatibility. However, the
frequency of disinfection should be based upon allowable bacterial and/or endotoxin
limits in water and dialysate, trending of microbiological monitoring results, applicable
regulatory requirements and facility practices.
Frequency of disinfection or the method used may need to be changed if results do
not meet either the facility or regulatory body requirements (if applicable). Testing for
residual chemicals must be done prior to patient treatment (see 6.6 Verification of
the Absence of Residual Disinfectant in this section).
The PHOENIX can accommodate bleach disinfection as frequently as between each
treatment or daily. As a minimum, a daily disinfection (chemical, heat or heat citric) is
recommended.
Rev. B
Heat disinfection is also an option, and in addition a deproteinization procedure (for

example: bleach) should be done at least two times per week if heat/heat citric
disinfection is the primary (between each patient treatment or daily minimum)
disinfection method. This is to ensure that any accumulated organic material is
periodically removed from the hydraulic pathway. Such material can potentially
reduce the effectiveness of a disinfection process. Descaling with vinegar, citric acid
or acetic acid is also an important process to periodically perform to remove mineral
deposits which can also reduce the effectiveness of the disinfection process.
The PHOENIX offers a unique method for protecting the hydraulic pathway from
microbial contamination with the preparation of a bacteriostatic level of disinfectant.
This can be useful for overnight or weekend storage, and in an acute setting where
the time between uses is variable. This procedure is performed by setting the END
PROCESS MODE parameter to BACTERIOSTATIC in the Config/ADR/Chemical view
and then leaving the machine filled with a dilute (1:750) bleach or sodium
hypochlorite solution for a maximum dwell time of one week.
Note
It is recommended to alternate the disinfection methods and/or the disinfectants, in order
to optimize cleaning, descaling and disinfection of the machine.
Note
The test procedure used for verification of the effectiveness of disinfection or sterilisation is
available on request.
Rev. B
SECTION 6 - CLEAN/DISINFECT 6-3
Descaling Tables
Precipitate Control (Descaling): Following every treatment
Chemical Uptake ADR Uptake Site Frequency Cycle Time

Concentration Cycle
Acid 3 meq/L Acid Descaling Acid Following 3-5 minutes
Concentrate Content Concentrate every treatment (Configuration)
connector (Bicarbonate
(white) dialysis)
White Distilled 5% Acetic Acid Descaling Acid Following 3-5 min
Vinegar or 5% Content Concentrate every treatment (Configuration)
Acetic Acid connector (Bicarbonate
(white) dialysis)
Precipitate Control (ADR): Periodic procedures
Chemical Uptake ADR Uptake Site Frequency Cycle Time

Concentration Cycle
White Distilled 5% Acid Content Chemical Rear 1,2, or Daily Chemical
Vinegar or 5% Disinfect chemical Disinfect = 15
Acetic Acid connector min
(yellow) (Configuration)
Acetic Acid 30% Chemical Rear 1,2, or Twice a week Chemical

Disinfect chemical Disinfect = 15
connector min
(yellow) (Configuration)
Citric Acid See Section - Heat Citric Rear 1,2, or Daily 24 min or 28
Specifications Disinfect chemical min if the
connector DIACLEAR
(yellow) Ultrafilter is
installed.
(Configuration)
Note
Cycle Time may be increased for heavy precipitate.
Rev. B
Disinfection Table
Flow Path Disinfection (ADR)
Method Uptake ADR Uptake Minimum Maximum Cycle Time

Conc. Cycle Site Frequency Frequency
Chemical See the Chemical Rear 1,2, or Daily Following 15:00 to 30:00 or
Specifications Disinfect chemical each 28:00 to 43:00 if
(See Section - section. connector treatment END PROCESS
Specifications (yellow) MODE is set
for the Bact.
disinfectants (Configuration)
list)
Heat - Heat - Daily Following 18 min or 36
Disinfect (Note 1) each min if the
treatment DIACLEAR
Ultrafilter is not
installed.
20 min or 40
min if the
DIACLEAR
Ultrafilter is
installed.
(Configuration)
Citric Acid See the Heat Citric Rear 1,2, or Daily Following 24 min or 28
Specifications Disinfect chemical (Note 1) each min if the
section. connector treatment DIACLEAR
(yellow) Ultrafilter is
installed.
(Configuration)
Note 1
A deproteinization procedure (i.e. Bleach) should be performed at least 2 times per week.
Rev. B
6.1 Disinfection
Select the ADR Selection key on the IDLE view. A new set of Action/Selection
keys appear and the ADR schedule is displayed:
12:30 IDLE: SELECT ADR
CHEM PROCESS
HEAT
RINSING
CCK LINES
RINSE

CLOSE
Select CLOSE to return to the IDLE view.
The PHOENIX machine is able to perform a variety of ADR procedures. A brief list is
as follows:
CHEMICAL DISINFECTION
A. Disinfection - front of machine: The uptake of disinfectant is via the Yellow

Connector on the front panel. At completion of the disinfectant tank filling, the
Yellow Connector is replaced in its Rinse Port on the front panel of the machine.
This disinfection cycle includes the entire hydraulic circuit.
B. Disinfection - rear of machine: Uptake of disinfectant is from the chemical

container stored on the rear of the machine. This disinfection cycle includes the
entire hydraulic circuit.
Rev. B
DISINFECTION WITH HEAT (Not available on 12 A version)
C. Heat disinfection: Performed by circulating heated water through the hydraulic

circuit.
D. Heat citric disinfection front of machine: Performed by using citric acid drawn
into the machine via the Yellow Connector attached to the disinfectant container
on the front panel, in combination with circulaton of heated water through the
hydraulic circuit.
E. Heat citric disinfection rear of machine: Performed by using citric acid drawn
into the machine from the disinfectant container stored on the rear of the machine
in combination with circulation of heated water through the hydraulic circuit.
RINSING
Fresh RO water flushes the hydraulic circuit.
Rev. B
6.2 Chemical Disinfection
6.2.1 Disinfection
6.2.1.1 HOW TO PROCEED
To perform chemical disinfection:
Press the CHEM PROCESS Selection key.
The control of the process continues by displaying the next view:

12:30 SELECT
CHEMICAL
CHEM PERS 1
CHEM PERS 2
CHEM PERS 3
CHEM PERS 4
CHEM+CENTRAL
BICARB LINE
BPM REPORT MACHINE

CLOSE
Note
CHEM PERS 1 TO 4 represent the four customized chemical disinfection selections
available. Selections made in the Config\ Chemical view allow a different set of parameters
for each chemical disinfection selection.
Note
Selection of the CHEM+CENTRAL BICARB LINE Action key initates the Central
Concentrate Lines Disinfection process. Refer to Section 03 - CENTRAL CONCENTRATE
SUPPLY, for the complete description of this process.
This section describes only the chemical disinfection process when selecting CHEM PERS 1
TO 4.
Rev. B
6.2.1.1.1 List of Parameters and their meanings
When the customized chemical disinfection type is selected a new view with the
corresponding parameters appears.
Note
Each customized chemical disinfection type could have a specific set of parameters
different from the others.
The number of parameters that appears on this view depends on the selections made
in the Config\ CHEM PROCESS \Chemical selection view. A brief list of the possible
parameters follows:
DISINF TIME: The default value for this parameter is the lowest value necessary to
ensure disinfection of the machine when an approved disinfectant is used (see
Section 9 Specifications, in this manual). The operator may therefore accept this
time or increase it.
pH Min and pH Max: these parameters appear only if the parameter pH MONITOR
on the Config\ADR\CHEM PROCESS view is set to YES. During the process an alarm
is triggered when the pH value is outside the range selected by the operator for the
two parameters.
RINSING TIME: when this parameter is set to a value between 15 min and 50
minutes, a rinsing phase is automatically performed, unless the disinfection procedure
is stopped.
When the END PROCESS MODE parameter is set to Bact. or None, the rinsing
process is not performed automatically.
AUTO OFF: if NO is selected, the machine returns to the IDLE view at the end of the
process, if YES is selected, the machine turns OFF automatically.
END PROCESS MODE: this parameter may be set on the Config\ADR\Chemical

\Chemical selection view.
When this parameter is set to None, at the end of the chemical disinfection process,
the machine returns to the IDLE phase.
When this parameter is set to Bact., at the end of the chemical disinfection, the
machine is left filled with a dilute bleach or sodium hypochlorite solution. In this case
a Bacteriostatic Disinfection is performed.
When this parameter is set to Rins., at the end of the chemical disinfection process,
the machine performs a RINSING process for the time set for the parameter RINSING
TIME.
LIQUID INLET: This parameter specifies the line through which the uptake of
disinfectant is performed. This parameter can be set to FRONT, REAR 1 or REAR 2,
only if the EXTERNAL JUG USE parameter is set to YES in the Config/Mach.Conf view.
When set to YES, the EXTERNAL JUG USE parameter allows the machine to uptake
disinfectant from the chemical connector (yellow) on the FRONT of the machine or
from REAR 1 or REAR 2 at the back of the machine. When set to NO the internal
disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the
front of the machine.
To change the parameter selection press the SET button.
Rev. B
6.2.1.2 HOW TO START THE PROCESS
This procedure depends upon the selection of the parameters EXTERNAL JUG USE
and LIQUID INLET:
EXTERNAL JUG USE: NO

LIQUID INLET: FRONT
Disconnect the Yellow Connector from its Rinse Port on the lower front panel
of the machine and connect it to the Yellow Wand. Immerse the Yellow Wand
into the disinfectant container.
Check that the Concentrate Connectors (white and blue) are in their correct
position in their Rinse Ports on the lower front panel of the machine. The BiCart
Holder must be in the rinse position, with the BiCart Holder Arms closed.
EXTERNAL JUG USE: YES

LIQUID INLET: FRONT

LIQUID INLET: REAR 1/ REAR 2
Ensure that the disinfectant connector (present on the rear of the machine) is
correctly inserted in the disinfectant container located on the rear of the
machine. Also verify that there is enough liquid to perform a disinfection
procedure.
Check that the all connectors (white, blue and yellow) are inserted in their Rinse
Ports on the lower front panel of the machine. The BiCart Holder must be in
the rinse position, with the BiCart Holder Arms closed.
Select the appropriate Chemical Action key. The following view is displayed:
12:30
ADR PROGRESS
DISINF TIME RINSING TIME

min:s min:s
END PROCESS AUTO OFF

MODE
PH VALUE LIQUID INLET
BPM REPORT MACHINE

CLOSE
Rev. B
Note
After selection of the type of chemical disinfection, the corresponding name appears
highlighted in the status area.
The machine uptakes approximately 180 ml of disinfectant to fill an internal tank.
Note
If any problems occur while the disinfectant is being taken up into the internal tank, the
machine will automatically empty and refill the tank.
An Operator Message will appear:
If LIQUID INLET is set to FRONT at the completion of disinfectant uptake, the

following alarm message is displayed:
Disinf Connector Position
Reinsert the Yellow Connector into its Rinse Port. The alarm will automatically
clear and the disinfection procedure will restart.
The current disinfection process begins disinfection of the hydraulic circuit of the
machine.
Rev. B
6.2.2 Chemical Disinfection Process in progress

The value of the DISINF TIME parameter automatically decreases as the process
proceeds.
Disinfection stops:
When the machine goes into an alarm condition during an ADR process and the
operator takes no action, the machine will automatically turn OFF after 30 minutes
following completion of the DISINF TIME or RINSING TIME.
When the CLOSE Action key is selected.
If the CLOSE Action key is pressed before the default time has elapsed, the process is
not considered complete.
WARNING
A disinfection process must be followed by a complete RINSING process. If not, on
subsequent SETUP the machine will not allow the selection of the DIALYSIS
process.
Note
If the END PROCESS MODE parameter is set to None on the Config\ADR\Chemical view,
at the end of the chemical disinfection process, the machine returns to the IDLE phase
without performing a RINSING process.
To prevent damaging the machine, do not leave the machine filled with disinfectant
solution for a prolonged period: follow the same time limits, for each disinfectant
solution, listed in the Section 9 Specifications, of this manual.
Perform a complete RINSING process before the subsequent SETUP.
Note
A disinfection process in progress has priority over a process programmed in the
Config/ADR/AutoStart view.
Note
At the end of a process programmed by the AutoStart feature, if the AUTO OFF parameter
is set to YES, the machine will ignore this selection and will return to the IDLE view.
Note
When the machine goes into an RESTART alarm condition during an ADR process
programmed by the AutoStart feature, the machine will automatically return to the IDLE
view 10 minutes after the alarm appearance. An Operator Message will appear informing
the operator than an alarm occurred. No other automatic process will be performed until
the operator will successfully complete a disinfection process that has been started
manually.
Rev. B
6.3 Disinfection with heat (not available on 12 A version)
6.3.1 Heat disinfection
To perform a Heat Disinfection:
Check that all the connectors (white, blue and yellow) are inserted in their Rinse
Ports on the lower front panel of the machine. The BiCart Holder must be in the
rinse position with the Arms closed.
Press the HEAT Selection key on the ADR view. The following view is displayed:
12:30 HEAT SELECTION
HEAT
HEAT WITH CWP
HEAT CITRIC
BPM REPORT MACHINE

CLOSE
Rev. B
Select the HEAT Action key. The following view is displayed:
12:30
HEAT PROC. IN
PROGRESS
DISINF TIME AUTO OFF

min:s
COOLING
YES
BPM REPORT MACHINE

CLOSE
The default value of the DISINF TIME parameter is the lowest value necessary to
ensure disinfection of the machine. The operator can therefore accept this time or
increase it.
AUTO OFF: If this parameter is set to NO, the machine returns to the IDLE view at
the end of the process. If set to YES, the machine turns OFF automatically, 15 minutes
after the beginning of the cooling phase, or 1 minute after reaching the threshold
temperature of 37C (98.6F).
COOLING: When performing a standard Heat Disinfection, if the parameter value is

YES, the machine will perform the cooling phase at the end of the Heat Disinfection
process. When performing a Heat Disinfection using a Centralized Heat Disinfection
System, the parameter value should be set to NO, the machine will perform only a
brief rinsing/cooling phase (30 sec.) at the end of the Heat Disinfection Process.
Note
The COOLING parameter can not be changed by the operator. Its value is automatically
set by the machine with the selection of the Heat Disinfection process.
To change the parameter selection, press the SET button.
Rev. B
6.3.1.2 CENTRALIZED HEAT DISINFECTION SYSTEM
A Centralized Heat Disinfection System may be used.
WARNING
To be compatible with this feature the PHOENIX machine must be retrofitted with
the CWP Adapter kit.
Failure to use the CWP Adapter kit may result in damage to components in the
PHOENIX machine.
WARNING
The temperature of the inlet water to the machine must be lower than 95C
(203F).
To perform a Heat Disinfection using a Centralized Heat Disinfection System:
Check that all the Connectors (white, blue and yellow) are inserted in their Rinse
rinse position with the Arms closed.
Press the HEAT Selection key on the ADR view and then press the HEAT WITH
CWP Action key. The following view is displayed:
12:30
HEAT PROC. IN
PROGRESS

min:s
COOLING
NO
BPM REPORT MACHINE

CLOSE
When a Centralized Heat Disinfection System is used, the selection of the AUTO OFF
parameter to YES causes the machine to turn OFF, even if the liquid is not cold, at the
end of the brief rinsing/cooling phase (approx. 30 sec.).
Rev. B
6.3.2 Heat Citric disinfection
This procedure depends upon the selection of the parameters EXTERNAL JUG USE
and LIQUID INLET:
EXTERNAL JUG USE: NO

LIQUID INLET: FRONT
Press the HEAT Selection key on the ADR view and then select HEAT CITRIC.
Disconnect the Yellow Connector from its Rinse Port on the lower front panel of
the machine and connect it to the Yellow Wand. Immerse the wand into the citric
acid container.
Check that the Concentrate Connectors (white and blue) are in the Rinse Ports on
the lower front panel of the machine. The BiCart Holder must be in the rinse
position, with the Arms closed.

LIQUID INLET: FRONT

LIQUID INLET: REAR 1/ REAR 2
Press the HEAT Selection key from the ADR view and then select HEAT CITRIC.
Ensure that the Disinfectant Connector (present on the rear of the machine) is
correctly inserted into the citric acid container located on the rear of the machine
and that there is enough liquid to perform a disinfection procedure.
Check that the all Connectors (white, blue and yellow) are inserted in their Rinse
rinse position, with the Arms closed.
Rev. B
Select the HEAT CITRIC Action key. The following view is displayed:
12:30

min:s
LIQUID INLET PH VALUE
BPM REPORT MACHINE

CLOSE
Note
If any problems occur while citric acid is being taken up into the internal tank, the machine
will automatically empty and refill the tank.
A message is displayed:
At the end of this process, the following message is displayed:
DISINF CONNECTOR POSITION
Reinsert the Yellow Connector into its Rinse Port. The alarm will automatically
clear and the disinfection procedure will restart.
WARNING
In the Heat Citric phase, it is important that only citric acid is used and no other
disinfectant.
Rev. B
pH Min and pH Max: These parameters appear only if the parameter pH MONITOR
on the Config/ADR/HEAT/HEAT CITRIC view is set to YES.
AUTO OFF: If NO is selected, the machine returns to the IDLE view at the end of the
process, if YES is selected, the machine turns OFF automatically.
LIQUID INLET: Identifies the line through which the uptake of citric acid is performed.
This parameter can be set to FRONT, REAR 1 or REAR 2.
Rev. B
6.3.3 Heat/Heat Citric Process in Progress (not available on 12 A

version)
The value of the DISINF TIME parameter automatically decreases as the process
proceeds.
During whole process heat water flows in the Hydraulic circuit. In order to alert the
operator the following message appears:
Don t remove any connectors: hot water
Disinfection stops:
When the machine goes into an alarm condition during Disinfection and Rinsing
and the operator takes no action, the machine will automatically turn OFF 30
minutes after completion of the DISINF TIME or RINSING TIME.
When the CLOSE Action key is selected.
Note
A disinfection process in progress has priority over a process programmed in
Config/ADR/AutoStart.
Note
Note
When the machine goes into an alarm condition during an ADR process programmed by
the AutoStart feature, the machine will automatically return to the Idle view 10 minutes
after the alarm appearance. An Operator Message will appear informing the operator that
an alarm occurred. No other automatic process will be performed until the operator
successfully completes a disinfection process that has been started manually.
Rev. B
6.4 Rinsing
To perform this process:
Select the RINSING Action key on the ADR view:
12:30 IDLE: SELECT ADR
CHEM PROCESS
HEAT
RINSING
CCK LINES
RINSE

CLOSE
Note
Selection of the CCK LINES RINSE Action key initates the Central Concentrate Lines Rinse
process. Refer to Section 03 - CENTRAL CONCENTRATE SUPPLY, for the complete
description of this process.
This section describes only the Rinsing process when selecting the RINSING Action key.
Set the appropriate value for RINSING TIME using the SET button.
The default value is the lowest one which will ensure rinsing of the machine.
Therefore this time can be accepted or increased.
AUTO OFF: If this value is set to NO, the machine will return to the IDLE view at the
end of the process; if it is set to YES, the machine will turn OFF automatically.
Check that all connectors (white, blue and yellow) are inserted in their Rinse Ports
on the lower front panel of the machine. The BiCart Holder must be in the rinse
position, with Arms closed.
Rev. B
The process now begins and the following view is displayed:
12:30
ADR PROGRESS
RINSING TIME AUTO OFF

min:s
BPM REPORT MACHINE

CLOSE
During Rinsing, the machine performs the UF Vessel Level Detectors Test.
Note
When the UF Vessel Level Detector Test fails, the following operator message will appear:
Emptying UF Vessel forced

The process time will be increased.
Rev. B
6.4.1 Rinsing in progress

The value of the RINSING TIME parameter automatically decreases as the process
proceeds.
The process stops:
When the time value set for the RINSING TIME parameter is elapsed.
When the machine goes into an alarm condition during Disinfection and Rinsing
and the operator takes no action, the machine will automatically turn OFF 30
minutes after completion of the DISINF TIME or RINSING TIME.
If the CLOSE Action key is pressed.
If the CLOSE Action key is selected before the default time has elapsed, the process is
not considered complete.
When the time value set for the RINSING TIME parameter is elapsed, the machine
will perform a tank emptying phase. When this process has been completed, the
machine returns to the IDLE view.
WARNING
Verify the absence of residual disinfectant, before connecting a dialyser.
Note
A rinsing process in progress has priority over a process programmed in
Config/ADR/AutoStart.
Note
Note
When the machine goes into an RESTART alarm condition during an ADR process
programmed by the AutoStart feature, the machine will automatically return to the IDLE
view 10 minutes after the alarm appearance. An Operator Message will appear informing
the operator than an alarm occurred. No other automatic process will be performed until
the operator successfully completes a disinfection process that has been started manually.
6.5 ADR Action Keys availability

Depending on the correct or incorrect completion of the last ADR process
performed, the following ADR Action keys are available:
Rev. B
HEAT HEAT HEAT WITH CHEM CHEM+CENTRAL RINSING CCK LINES

CITRIC CWP PROCESS BICARB LINE RINSE
Rinsing Performed Correctly
X X X X X X X
Rinsing not Performed Correctly
(See Note 1) X X X X X X X
Chemical Proc. Performed Correctly
X
Chemical Proc. NOT Performed Correctly
(See Note 2) X
Heat Proc. Performed Correctly
X X X X X X X
Heat Proc. NOT Performed Correctly
X X X X X X X
Heat CWP Proc. Performed Correctly
X X X X X X X
Heat CWP Proc. NOT Performed Correctly
X X X X X X X
Heat Citric Proc. Performed Correctly
X X X X X X X
Heat Citric Proc. NOT Performed Correctly
(See Note 2) X X
Rinse+Bicarb Line Performed Correctly
X X X X X X X
Rinse+Bicarb Line Not Perf. Correctly
X
CCK Lines Rinse Performed Correctly
X X X X X X
CCK Lines Rinse NOT Performed Correctly
X X X X X X
Chem+Bicarb Line Proc. Perf. Correctly
X
Chem+Bicarb Line Proc. NOT Perf.
Correctly X
(See Note 3)
Rev. B
Note 1
When a RINSING process has not been correctly completed and the ADR process
previously performed was a Chemical Disinfection or a Heat Citric Disinfection not
correctly completed, only the RINSING Action key remains available.
Note 2
When the CLOSE Action key is selected within approximately 30 seconds after the
Disinfection process selection (Chemical or Heat Citric), the process selection is cancelled
and all the keys that were available before starting the Disinfection process will remain
available.
Note 3
When a Central Bicarbonate Line disinfection has not been correctly completed, only the
Central Bicarbonate Line disinfection can be performed.
Rev. B
6.6 Verification of the Absence of Residual Disinfectant
Samples for residual disinfectant concentration testing may be obtained, at the end of
RINSING or in SETUP prior to using the machine for a patient treatment, from the
following sites:
Dialysate line: remove the inlet dialysate line (blue connector) from its bypass port
on the left side of the machine and collect a fluid sample.
Acid/Acetate Connector.
To take a sample from the Acid/Acetate Connector:
Insert the Sampling Connector into the red Acid/Acetate Rinse Port.
Allow liquid to flow from the sampling connector for a few seconds to adequately
rinse the sampling connector.
Obtain a sample for testing.
Note
Due to the fact that the internal volume of the PHOENIX machine is less than 750 ml and
the drain hose may have a volume of between 300 ml and 600 ml, the Residual
Disinfectant test performed at the drain hose of the machine does not reflect the quality of
the rinsing of the PHOENIX machine and can give a positive result even if the PHOENIX
has been rinsed correctly.
Rev. B
6.7 Water Inlet Line Disinfection
6.7.1 General
The segment of the water inlet line between the treated water supply and the end of
the hose connected to the inlet port of the heater exchanger is not automatically
cleaned/disinfected by the machine.
If the machine is stored, switched OFF, or is in IDLE for a long period, it is
recommended that the following special cleaning/disinfection procedure is
performed.
6.7.2 Disinfection Procedure

Assemble a pump device with the components described in Figure 6.1. Contact
your Local Representative for information about where to obtain this device, or the
components to assemble it.
Prepare a dilute sodium hypochlorite (bleach) solution (15 ml of 5.25% sodium
hypochlorite solution in 500 ml of room-temperature treated water) in a chemical-
resistant container.
Turn OFF the treated water supply to the PHOENIX machine.
Disconnect the machines water hose from the treated water supply and connect
it to the connector on the pump device (on the left side of the device, as shown in
Figure 6.1.)
Insert the free end (disinfectant suction line) of the pump device into the
disinfectant solution container.
Turn ON the PHOENIX machine and enter the ADR/DISINFECTION mode. Press
the CHEM PROCESS Selection key and then select a customized disinfection key
that corresponds to the uptake of disinfectant from the Yellow Connector on the
lower front panel of the machine.
Remove Yellow Connector from its Rinse Port and allow it to hang unconnected.
When the machine alarms because of the absence of water, use the syringe on the
pump device to pump the disinfectant solution into the inlet water line.
Alternately, completely fill the syringe with the disinfectant solution and then
completely empty it into the water inlet line line by firmly pushing in the syringe
plunger.
Repeat this operation until the disinfectant solution container is almost empty.
Note
Point the syringe downward during the emptying phase to prevent air from entering the
water inlet line.
Turn OFF the machine and leave the water inlet hose filled with the disinfectant
solution for a period of time sufficient to achieve microbiocidal efficacy, but not for
a period longer than the maximum time recommended in Section 9
Specifications, in this manual.
Carefully disconnect the end of the inlet water hose from the pump device.
Rev. B
Switch the PHOENIX machine ON, enter the ADR/DISINFECTION mode, and
select RINSING until the machine goes into an alarm condition due to the absence
of water.
Note
It is recommended to avoid the selection of HEAT DISINFECTION process when
disinfectant solution is present in the initial section of the machines hydraulic circuit.
Note
The purpose of this operation is to empty the end of the water inlet hose to avoid
disinfectant from contacting the treated water supply flowpath.
Reconnect the machines water inlet hose to the treated water supply system.
Turn on the treated water to the PHOENIX machine.
Insert the Yellow Connector in the Rinse Port on the lower front panel of the
machine.
The RINSING process will restart. Wait until the machine has completed the.
RINSING process
WARNING
A disinfection process must be followed by a complete RINSING process.
Proceed with the standard procedure to SETUP the machine for DIALYSIS.
Note
To perform a test for residual disinfectant concentration, follow the Verification of the
Absence of Residual Disinfectant Procedure described in this section.
Rev. B
NO return valves
adaptor for the Disinfectant suction
connection to the inlet
water line
Silicon T connector
PVC tube 3.5 * 5.5 mm;

L = 200 mm
PVC tube 4.6 * 6.8 mm; L= 1000 mm
50 ml Syringe
Figure 6.1
Rev. B
6.8 External Cleaning and Periodic Inspections

The PHOENIX must be cleaned as often as required by operating conditions and the
facilitys protocol.
The PHOENIX has been designed to function with a minimum of maintenance.
The ambient conditions, as well as frequency and duration of use determine the
required cleaning frequency.
6.8.1 External surface cleaning

The external surfaces of the machine to be cleaned are:
Blood Pump and the Line Clamp
Air Bubble Detector
Clamp Housings
Heparin Pump Syringe Holder
Arterial and Venous Pressure Sensors
BiCart Holder
Dialyser Holder
Single Needle Holder
the WHO Drain Port and WHO door
the Touchscreen
Particles and dust on the external surface of the machine can be removed with a soft
cloth or brush.
All other deposits can be removed with a soft cloth dipped in a detergent/disinfectant
solution.
The following detergents/disinfectants are suggested:

Liquid soap.
Ethyl Alcohol (90%).
Isopropyl alcohol (70%).
Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach
diluted with water at a ratio of 1:50.
Note
If residual detergent/disinfectant remains on the surface of the machine after external
cleaning, it has to be removed with a soft cloth dipped in water to avoid damaging or
discoloring the plastic parts of the machine.
Detergents/Disinfectants have to be removed from the external surface of the machine
only after the minimum dwell time for cleaning is elapsed (refer to the
detergent/disinfectant instructions for use for the minimum dwell time recommended to
guarantee an effective cleaning).
Rev. B
Note
The PHOENIX Touchscreen may also be cleaned when the machine is switched on.
Press the Machine Navigation Key, then the CLEANING SCR Action Key. The
CLEANING SCR Action Key disables all the Touchscreen functions for 10 seconds,
allowing the Touchscreen to be wiped with a soft cloth without activating any Action
keys.
WARNING
For the Touchscreen cleaning use the following disinfectants:
Isopropyl alcohol (70%);
ppm)/Bleach diluted with water at a ratio of 1:50.
WARNING
Do not use chemicals which might damage the plastic parts of the machine.
Avoid chemicals containing benzene, toluene, xylene, acetone or similar solvents.
WARNING
Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid
damaging the metallic parts of this component.
WARNING
Any liquid spilt on the machine must immediately be removed to prevent it from
seeping into the machine.
6.8.2 External components Cleaning

It is advisable to clean periodically certain external components of the machine, such
as:
Dialysate Connectors
Concentrate Connectors
Chemical Connectors
Concentrate Wands
by immersing them in a disinfectant solution. The frequency of this cleaning
procedure depends on the use of the machine, on the operating conditions and the
ambient conditions.
After the immersion in the disinfectant solution, the machine components must be
thoroughly rinsed with treated water to remove all disinfectant residuals, prior to using
them during dialysis.
The length of the immersion depends on the disinfectant concentration used.
Rev. B
WARNING
To prevent cross-contamination problems resulting, for example, from blood
leakage from the bloodline or from the dialyser (including blood leak into the
hydraulic circuit) the components listed above must be cleaned by immersing
them into a disinfectant solution or by exposing them except the Concentrate
Wands - to a steam sterilisation procedure (121C for at least 30 minutes).
Careful attention must be paid to dismounting and re-mounting Dialysate
Connectors, Concentrate Connectors and Chemical Connectors in order to avoid
damages to those components and leakages from those components.
WARNING
To prevent damage to the components listed above, do not leave them immersed
in the disinfectant solution for a prolonged period; the proper immersion time is
related to the disinfectant dilution used.
When the dilution is the same as that used in the machine during DISINFECTION,
follow the same time limits:
(For further information see Section 9 - SPECIFICATIONS, in this Operators
Manual).
Rev. B
6.8.3 Visual inspection

The machine must be periodically inspected (at least once a week) to check for:
Broken or damaged switches
Broken or twisted power supply cables
Cracks in the structure
Corroded metal parts
Unattached loose or missing hardware
Blood Pump Rotor damage and that the Rotor surface remains smooth
Damage to the Arterial and Venous Pressure Port seals and that their surface is
smooth
If any of the damage listed above is noted, avoid using the machine, until the damage
has been repaired and the machine is in proper working order.
6.8.4 Storage
When not in use, the machine must be kept in a safe place such as a closet free from
dust, in ambient conditions, as recommended in the Section 9 Specifications, in this
manual.
Avoid storing in busy areas where the machine may be moved or knocked over.
Avoid storing in conditions of high humidity.
If the machine will be stored for an extended period, it is suggested to carry out a
chemical bacteriostatic disinfection at least once per week. To perform chemical
disinfection refer to 6.2 Chemical Disinfection in this section.
WARNING
WARNING
After a prolonged period of storage, Service must be called to return the machine
to proper working order.
Only store at temperatures below 0 C when the hydraulic circuit has been
completely emptied.
Rev. B
6.8.5 Cartridge Holder O-Rings Inspection and Greasing
Every 2 weeks it is necessary to:

Check the four O-rings on the Cartridge holder pressure monitoring sensors for
nicks, damage, or wear and replace them if necessary;
Grease the 4 O-Rings to improve the seal to the Cartridge and reduces wear of
O-rings.
To inspect and grease the O-rings proceed as follows:
1. Remove possible grease in excess using an alcool based solution (refer to the list of
chemicals for external cleaning suggested on this section).
2. Check, that the O-Ring surface and the metal stems are free from any extraneous
particles and check for nicks, damage or wear. Replace the O-Rings if necessary.
3. Apply a very thin coating of silicon grease (PHOENIX spare part code 6975395) all
around the four O-Rings. The silicon grease can be applied either manually or
using a grease Dispenser. Refer to the two procedures described below.
Manual Greasing procedure
Place a small quantity of silicon grease

on your finger and apply it uniformly all
around the O-Rings.
Pay careful attention to ensure that no
grease enters inside the metal stems:
grease in the stems may result in false
pressure readings. (See Figure 6.2).
Figure 6.2
Rev. B
Procedure with Grease Dispenser:
Ensure that no grease is present on the

Grease Dispenser (spare part code
6977854) around the Grease Dispenser
pin.
Screw the Grease Dispenser to the
silicon grease tube and then insert the
pin of the Grease Dispenser in the
pressure coupling hole (See Figure 6.3).
Figure 6.3
Press firmly to fit the Grease Dispenser

against the pressure coupling.
Press the silicon grease tube to allow a
thin quantity of grease exits and rotate
the tube twice. (See Figure 6.4).
Remove the Grease Dispenser.
Verify that a thin quantity of grease has
been applied all around the O-Ring.
Figure 6.4
4. Check, that the front of the couplings and the holes in the metal steams are free
from any extraneous particles and exceeding grease.
Rev. B
Rev. B
7 COMMUNICATION SYSTEM
7. SECTION 7 - COMMUNICATION SYSTEM
7.1 General Description
Note
This Section contains references to all the communication software systems to which the
Phoenix machine can be connected, including the Exalis System.
The communication system is able to transfer to different media the results of data
acquired during a dialysis treatment.
The system is designed to be compatible with different data acquisition systems

running on external networks.
Depending on the configuration of the unit, and the type of acquisition system the
PHOENIX will be connected to, the output may be as follows:
1. An internal backup memory. This function would be processed by a dedicated PC

program (Exalis).
2. A personal computer or network directly connected to the PHOENIX dialysis
machine (for example CentryNet or Exalis system).
The PHOENIX is also able to display a run-time dialysis report on the Touch Screen,
containing the data acquired since the start of the treatment. To view this report, press
the Report Navigation key.
In addition, the user can mark different patient related events that occur during the
treatment (incidents, intake, medication and medication dose) in order to highlight
them on the dialysis report.
Note
The communication system features are linked to an external system able to acquire data
from PHOENIX. This chapter refers to programs running on a Personal Computer
connected to PHOENIX. The programs able to manage the PHOENIX Communication
System and described in this section are:
CentryNet system Data Collection software

Exalis Dialysis Management Tool
Refer to each softwares manual for a detailed description of the program.
If the PHOENIX machine is connected to the RIMS system or if programs other than
CentryNet system Data Collection software and Exalis Dialysis Management Tool are
used, refer to the proper softwares manual for a detailed description of the program
features.
Rev. B
WARNING
PHOENIX makes available the dialysis related data through connection to various
external devices for storage and display. The intended use of this information is to
support the physicians, but it cannot be considered as the sole data to prescribe
any therapeutic or pharmacological action for the patient. It is the responsibility of
the physician to verify all data.
WARNING
The present software allows information to be gathered about individuals and the
user must be aware that the use of the information processed or generated by the
software is restricted in most countries by legal dispositions such as the Directive
95/46/EC of the European Parliament and of the Council of 24 October 1995. The
user shall therefore take all necessary measures to ensure the confidentiality of the
information which is monitored by means of the software.
WARNING
The CentryNet system displays on its treatment screens the concentrations for two
conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter. As
the PHOENIX provides only conductivity information (in mS/cm), the CentryNet
entries for Sodium will be approximate values obtained by multiplying the Final
conductivity (mS/cm) by 10. A Final conductivity of 13.6 mS/cm will be recorded
in CentryNet as a Sodium Level of 136 mEq/Liter. Refer to Section 9
Specifications of this manual for the exact relation between concentration and
conductivity.
Rev. B
SECTION 7 - COMMUNICATION SYSTEM 7-3
7.2 Exalis Functional Description

The information in this section is valid when the PHOENIX unit is configured for Exalis.
The operation of the PHOENIX machine when used with the CentryNet Data
Collection System is described in the CentryNet System Connection section.
The systems use different data acquisition methods. Exalis includes:
Synchronous acquisition
The system is able to define a sampling time, typically 5 minutes, and a storage buffer
dimension for each machine parameter that can be acquired. The PHOENIX has a
default pre-setting for this type of acquisition, which can be personalised via a
personal computer.
Asynchronous acquisition
The system can be configured to define threshold limits for those machine parameters
which can be acquired, i.e. alarms and events. The system acquires the whole
machine status at the moment a parameter exceeds its threshold limit. The system
also acquires this status when the parameter returns within its threshold limits.
Alarm acquisition
The system is able to immediately acquire information regarding alarms active on the
equipment. Event recording includes alarm activation and their reset.
Operating phase acquisition

The system is able to record the input and the output from the different operating
phases of the machine. The records are saved in the backup memory.
Instantaneous acquisition
The system is able to transfer the real time machine status.
Data storage
The PHOENIX Config environment allows the user to select the data storage mode
for the records acquired by the acquisition task. The PHOENIX can store up to 3 or 4
treatments, depending upon the acquisition sample time(s).
Rev. B
Storage on backup memory

This mode records all the data in the backup memory of the equipment so that it can
be retrieved later by the appropriate PC program (Exalis).
Note
This chapter mentions a defined machine operating condition, which is the data
acquisition state. Thus it refers to start and stop conditions of this state. These events
are:
Start of acquisition: DIALYSIS phase running after PAT CONNECT.
Stop of acquisition: confirmation of the EMPTYING Action key.
7.3 CONFIGURATION of Communication Environment
The configuration of the Communication environment is described below. The first

choice to be made is the type of acquisition system that will be connected to the
PHOENIX:
CentryNet system
Exalis system
RIMS system
OTHERS
NONE
Note
Any modification in the type of acquisition system must be done when no PC is
connected to the PHOENIX and the communication between the acquisition system and
the PHOENIX has not been activated.
Depending on this selection, the following table will apply:
Rev. B
Parameter Values Exalis CentryNet RIMS OTHERS NONE
SW COMM SYSTEM CentryNet If NetworkType ==
Exalis Ethernet
RIMS
OTHER
NONE
(default NONE)
NETWORK TYPE Ethernet Default Ethernet N.A. (fixed to RS485 Default Ethernet
Seriall Serial communication)
BAUD RATE 9600(default); 4800; If NetworkType == N.A. If NetworkType ==
2400; 1200 Serial (fixed to 9600 baud Serial
for CentryNet)
IP ADDRESS From 0 to 255 for each field If NetworkType == If NetworkType ==
1st/2nd/3rd/4th (default 10.21.4.250) Ethernet Ethernet
SUBNET MASK/ From 0 to 255 for each field If NetworkType == If NetworkType ==
SUBNET MASK (default 255.255.255.0) Ethernet Ethernet
2nd/3rd/4th
GATEWAY/GATEWAY From 0 to 255 for each field
2nd/3rd/4th (default 10.21.4.31)
NET ROUTE1/NET From 0 to 255 for each field
ROUTE1 2nd/3rd/4th (default 0.0.0.0)
MASK ROUTE1/MASK From 0 to 255 for each field
ROUTE1 2nd/3rd/4th (default 0.0.0.0)
CCM IDENTIF Selectable from 1 to 255
(default 50)
STATION ID Selectable from 1 to 255
(default 50)
AUTOCHART TIME Selectable from 0 to 1 hour (steps of 15 minute
(default 30) increments)
OFFLINE TIMEOUT Selectable from 00:10 to 04:15 Coordinate with the (1:30 min:sec or 5
(Note 1) min:sec. Poll Delta Time seconds/station,
(default: 1:30 min:sec) setting in Exalis install which ever is larger)
setup. Recommended
minimum value = 1:30
min:sec
EXT SYNCHRO From 00:00 to 01:30 min:sec
in step of 5 sec.
The parameter applies and is enabled (displayed in Config \Communic. view)
Rev. B
SW COMM SYSTEM: Selection of the software system to which PHOENIX will be

connected.
Note
The choice OTHER, for the SW COMM SYSTEM parameter, is dedicated to the
PHOENIX machines connected to software systems other than CentryNet, Exalis and
RIMS system.
The choice NONE, for the SW COMM SYSTEM parameter, is dedicated to the
PHOENIX machines not connected to communication systems.
NETWORK TYPE: Selection of the hardware network topology.
BAUD RATE: Selectable by the user depending on the communication speed

required by the external software system program (default 9600 BAUD)
IP ADDRESS 1st/2nd/3rd/4th: TCP/IP Configuration Address of the unit - used if the

network connection is Ethernet. Each PHOENIX must have a unique identifier.
SUBNET MASK/SUBNET MASK 2nd/3rd/4th: Subnet Mask for the machine.
Note
In order to allow a proper configuration of the communication environment, the values
set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the
machine Calibration environment by a service technician (Refer to Section 8, in the
PHOENIX Service Manual, for a detailed description of the parameters to be set).
GATEWAY/GATEWAY 2nd/3rd/4th: parameter for internal use.
NET ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use.
MASK ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use.
Note
Certain parameters on the Communic. menu (GATEWAY, NET ROUTE1 and MASK
ROUTE1) are required only for some data communication software. Contact a Gambro
authorized technician to determine if the parameters are relevant to your software.
CCM IDENTIF: Communication code (CCM) that uniquely identifies the PHOENIX
within the network system. Each PHOENIX must have a unique identifier.
STATION ID: Code that identifies the placement of the PHOENIX within the clinical
network setting. Each PHOENIX must have a unique identifier.
If the acquisition system connected to the PHOENIX machine is the Exalis system, the
STATION ID parameter configuration allows to display of each PHOENIX location in
the Exalis room overview window.
If the acquisition system connected to the PHOENIX machine is the CentryNet
system, refer to 7.7.5 CentryNet Option Screen Setup Keys, in this section, for a
detailed description of the parameter meaning with the CentryNet communication
system.
Rev. B
AUTOCHART TIME: Sampling time used by the PHOENIX to automatically acquire

records for CentryNet.
OFFLINE TIMEOUT:
CentryNet: Alarm timeout used to signal a lack of communication with the
CentryNet software system.
Exalis: Timeout function used to signal a lack of communication with the Exalis
software system.
Note 1
The OFFLINE TIMEOUT value, for Exalis, must be calculated using the following formula:
Time = 3 x Poll Delta Time x Number of machines
Where Poll Delta Time is an Exalis configuration parameter and Number of machines
is the number of machine stations in the network. The recommended minimum value is
1:30 min:sec.
The OFFLINE TIMEOUT value, for CentryNet, must be calculated using the following
formula:
Time = 5 x Number of machine stations
EXT SYNCHRO: Timeout used at the switch ON of the machine to detect the
network presence.
Rev. B
7.4 Options of the Communication System
7.4.1 Patient Login

For the Communication System the Patient Login is a unique event for each dialysis
session, it cannot be re-triggered until the dialysis session is concluded or cancelled.
The Patient Login can be manual or automatic:
Manual Patient Login

In case of Standard Dialysis, after selecting the SETUP Action key, press the Report
Navigation key and then press the LOGIN Action Key. When the Patient Login is
activated, the LOGIN Action key disappears until the subsequent dialysis session.
Note
If a Standard Dialysis has been selected, the LOGIN Action Key is enabled only after the
SETUP Action key has been pressed.
Automatic Patient Login

In case of Patient/Rx Dialysis, after selecting a patient, the Patient Login event is
automatically triggered.
Note
If a Standard Dialysis has been selected and the LOGIN Action Key has not been pressed,
the Patient Login event is triggered automatically after pressing the PAT CONNECT
Action Key.
Rev. B
7.4.2 PRE POST Dialysis data handling.

This option allows the user to record data (manually or automatically) related to the
patients weight and blood pressure before and after the dialysis treatment.
The values that the acquisition system stores are:

PRE and POST WEIGHT
DELTA WEIGHT
PRE and POST LYING SYST
PRE and POST LYING DIAS
PRE and POST LYING PULSE
PRE and POST SIT SYST
PRE and POST SIT DIAS
PRE and POST SIT PULSE
PRE and POST STAND SYST
PRE and POST STAND DIAS
PRE and POST STAND PULSE
Note
This information has no effect on the treatment.
Depending on the operating phase of the equipment, the system allows the user to
input data.
Rev. B
PRE DIALYSIS DATA

The time between the Patient Login event and the DIALYSIS Action key
disappearance (after the RINSEBACK VOLUME value set has been reached) is
dedicated to the pre-dialysis data input (automatic or manual entry).
To enter the pre-dialysis data press the Report Navigation key, then the Summary
Navigation key. The following view will be displayed:
12:30
POST LYING SYST - mmHg

PRE LYING SYST mmHg
POST LYING DIAS - mmHg
PRE LYING DIAS mmHg
POST LYING HRAT - mmHg
PRE LYING HRATE - -mmHg
POST SITTING SYST - mmHg
PRE SITTING SYST- mmHg POST SITTING DIAS - mmHg
PRE SITTING DIAS mmHg POST SITTING H.RATE - mmHg PRE STANDING
PRE SITTING H.RATE mmHg POST STAND SYST - mmHg
PRE STAND SYST - mmHg POST STAND DIAS - mmHg
PRE SITTING
PRE STAND DIAS mmHg POST STAND HRAT - mmHg
POST WEIGHT - Kg
PRE STAND HRATE - mmHg
DELTA WEIGHT - Kg PRE LYING
PRE WEIGHT - Kg
TOTAL BLOOD - l TOTAL FLUID REMOVED -l

HEPARIN TOTAL - ml REAL TREAT TIME -h:min
REPORT SUMMARY
The selection of the Action key related to the value to be stored starts the BPM
measurement. The pressure measurement is stored by the acquisition system; it is
displayed in the view above and in the REPORT table (See the Dialysis Report
section).
Note
When the operator selects one of the three Action keys, it becomes highlighted and the
others disappear; if the Action key is pressed again, all three Action keys become
available again.
If the measurement has been taken by an external device, the value can be manually
entered using the SET button.
The REPORT table records the time that the measurement was taken, in case of BPM
measurement, or the time the measurement was stored, if the value was inserted in
SET mode.
The pre-dialysis data can be changed any time by using the SET button before the
EMPTYING phase.
Rev. B
POST DIALYSIS DATA

The time between the DIALYSIS Action key disappearance (after the RINSEBACK
VOLUME value set has been reached) and the Patient Login for the following dialysis
treatment is dedicated to the post dialysis data input.
To enter the post-dialysis data press the Report Navigation key, then the Summary
Navigation key. The following view will be displayed:
12:30
PRE LYING SYST - mmHg POST LYING SYST - mmHg

PRE LYING DIAS - mmHg POST LYING DIAS - mmHg
PRE LYING HRATE - mmHg POST LYING HRAT - mmHg
PRE SITTING SYST - mmHg POST SITTING SYST -- mmHg
PRE SITTING DIAS - mmHg POST SITTING DIAS - mmHg
PRE SITTING H.RATE - mmHg POST SITTING H.RATE - mmHg
PRE STAND SYST - mmHg POST STAND SYST - mmHg
PRE STAND DIAS - mmHg POST STAND DIAS - mmHg
PRE STAND HRATE - mmHg POST STAND HRAT - mmHg
PRE WEIGHT -Kg POST WEIGHT - Kg
DELTA WEIGHT - Kg POST STANDING
TOTAL BLOOD -l TOTAL FLUID REMOVED -l
HEPARIN TOTAL - ml REAL TREAT TIME - h:min POST SITTING
REPORT SUMMARY POST LYING
The selection of the Action key related to the value to be stored starts the BPM
measurement. The pressure measurement is stored by the acquisition system and is
displayed in the view above and in the REPORT table (See the Dialysis Report
section).
Note
When selecting one of the three Action keys (POST STANDING/POST SITTING/POST
LYING) before the EMPTYING Action key selection, the Dialyser Replacement procedure
will no longer be allowed for the current dialysis treatment.
Note
When the operator selects one of the three Action keys, it becomes highlighted and the
others disappear. If the Action key is pressed again, all three Action keys become
available again.
Rev. B
If the measurement has been taken by an external device, the value can be manually
inserted using the SET button.
The REPORT table records the time that the measurement was taken, in case of BPM
measurement, or the time that the measurement was stored, if the value was inserted
in SET mode.
The data can be changed any time before the Patient Login Login event (Patient/Rx
key select, LOGIN) for the following dialysis treatment.
When the post dialysis data has been specified, the following parameters are
displayed as in the view above:
TOTAL BLOOD
HEPARIN TOTAL
TOTAL FLUID REMOVED
REAL TREAT TIME
Note
After the insertion of the PRE and POST WEIGHT the DELTA WEIGHT is automatically
calculated and displayed in the POST DIALYSIS DATA view.
Rev. B
7.4.3 Event/Intervention Marking
The PHOENIX communication system allows the user to record specific patient-
related events, which have occurred during the dialysis treatment. The events
recorded are stored by the acquisition system (for example Exalis).
This feature is active only when the acquisition is running: starting from the selection
of the DIALYSIS Action key (Start of data acquisition) until the confirmation of the
EMPTYING Action key (Stop of data acquisition).
The data recorded are displayed also in the Report view (see the Dialysis Report
section).
The user can enter the EVENTS environment by pressing the Report Navigation key,
then the Events Navigation Key. The following view is displayed:
12:30
INTAKES MEDICATION
INCIDENT MED QUANTITY
REPORT SUMMARY DATA EVENTS
Rev. B
By pressing the SET button the operator can store particular events that are related to
the patient, including its typology, timing and value. Three main event groups are
identified (INTAKES, INCIDENT, MEDICATION) as follows:
12:30
INTAKES INCIDENT MEDICATION MED QUANTITY
150 CRAMPS NaCl 10

g mEq
Note
The MEDICATION and the MED QUANTITY parameter are strictly linked and must be
inserted in sequence. The medication data and the related medication dose are stored by
the communication system only if both the parameters, MEDICATION then MED
QUANTITY, have been confirmed.
Rev. B
7.4.4 Dialysis Report

The Dialysis Report contains a snapshot of some parameters related to specific
machine and patient events.
In particular, the report shows:
Pre Dialysis data
Start of Data Acquisition event
BPM measurements
DIASCAN measurements
Selection/deselection of the UF ONLY Action key
Patient events recorded within the PHOENIX interface: SUMMARY and Events
view
Start of particular procedures such as: Dialyser Replacement, BiCart Change,
Dialysis Mode Change (SN and DN), Acid Concentrate Supply Change, Change to
the use of Liquid Bicarbonate dialysate, WASHBACK completion.
Selection/deselection of the Action keys: PAUSE THERAPY, BYPASS,WLR
MINIMUM.
Occurrence of particular alarms such as: No Power, No Water
Selection of the SNAPSHOT Action key in the Report view
Pump speed changes (the values is stored 30 sec. after the last change)
Stop of Data Acquisition event
Post Dialysis data
The data collection for a patient starts:

after the Patient confirmation in Patient Dialysis
after PAT CONNECT in Standard Dialysis
when the LOGIN Action key is pressed
The data collected during a treatment remains available in the REPORT environment
until one of the three events listed above occurs. Whenever a new Patient Dialysis is
selected and confirmed, LOGIN is pressed, or PAT CONNECT is selected (in Standard
Dialysis), the REPORT table is emptied and is filled in with the data of the current
dialysis session.
Rev. B
The user can enter the REPORT environment by pressing the ReportNavigation key.
The following view is displayed:
Clk Ven P Art P BFlow Time Syst Dias Hrate Event Descrr Qty Unit LOGIN
Time
-- -- -- PRE STANDING MEAS

-- -- -- PRE LYING MEAS
-- -- -- PRE SITTING MEAS
SNAPSHOT
When the user enters this view, the data pointer is placed onto the last event
recorded. Using the PAGE UP , PAGE DOWN , UP , DOWN keys the user
can scroll through the Events list.
Some of the data recorded for each event can be seen only by pressing and
keys: Ven P (Venous Pressure), Art P (Arterial Pressure), BFlow (Real Blood Flow),
PSpeed (Blood Pump speed), TWL (Target Loss), UF R (UF Rate), TMP (only displayed
in DN), LP (Liters Processed), Cond (Conductivity), Qd (Dialysate Flow), T Hep (Total
Heparin infused), Kurea (Clearance), Kt, Dep V, Pl Con (Plasma Conductivity), Stroke
(Stroke Volume in SN).
Note
Modifications in the Blood Pump Speed are stored in the Report view only 30 seconds
after the last change in the Pump Speed value.
The time in which each event has occurres, is displayed in two different ways:
the Time column displays the time of the event recorded as time elapsed from
the Start of Acquisition event;
the Clk Time column displays the clock time of the event.
The SNAPSHOT Action key allows recording a generic event, it is a reminder for the
operator.
Rev. B
7.4.5 Dialysis Treatment Data

This view displays a list of some relevant dialysis parameters.
The user can enter the Data environment by pressing the Report Navigation key, then
the Data Navigation Key. The following view is displayed:
12:30
DIALYSIS TIME h:min TEMPERATURE C
DIFFUSION TIME h:min pH VALUE

TOTAL FLUID REMOVED Kg DIALYSATE FL. ml/min
TOT WEIGHT L Kg TMP mmHg
WEIGHT LOSS/H Kg/h END DIALYSIS TWL
TOTAL BLOOD l BLD SENS HIGH
CONDUCTIVITY mS/cm STROKE VOLUME ml
BICART COND mS/cm
Note
The STROKE VOLUME parameter is displayed only if performing a Single Needle dialysis.
Rev. B
7.5 Prescription Download with the Exalis System

WARNING
The present SOFTWARE must be used exclusively with the authority of a physician,
who is solely responsible for the use of the information processed by the
SOFTWARE.
7.5.1 General Description

The PHOENIX machine allows the user to start a dialysis treatment with a treatment
prescription received from a Personal Computer (Exalis software).
7.5.2 Functional Specifications

If the PHOENIX is connected to the Exalis System, which is configured for transfer of
the patient prescription, the PAT NETWORK Action key selection (in the PATIENT
CHOICE view) starts the procedure described below:
1) A keypad appears allowing the entry of the Patient Name:
NEW NAME Area
Q W E R T Y U I O P
Lock A S D F G H J K L
Shift Z X C V B N M ,; .:
\| ? ^ [ +*] @ <> -_ #
BackSpace << Space >> AltGr
PATIENT NAME UNDO
Rev. B
2) The PHOENIX displays a message to signal that it is waiting for an external

prescription.
3) The external Computer System retrieves the prescription assigned to that Patient
Name from its database and sends it back to the PHOENIX.
4) PHOENIX displays the prescription received to the user for confirmation (it may
be modified on the PHOENIX before starting the treatment)
Note
The Parameters not managed by the computer prescription are set with a default value.
7.5.3 Error Messages related to Computer Prescription
In the event of an error during the transfer of the prescription, the PHOENIX warns
the user with a specific superimposed window.
If the Patient Name entered is not available in the Exalis database:
Patient Not Recognized by Clinical Software

Check the Patient Name and retry.
Press the CONFIRM button and repeat the Patient Name entry procedure.
If at least one of the parameters in the patient prescription can not be accepted
by the machine:
Prescription Not Valid. Please Access the

Machine Page to Check the Wrong Parameter.
Press ENTER To Confirm And Proceed.
In the Machine view, the WRONG PRESC PAR: parameter displays the
prescription parameter causing the failure.
If an error occurred when trasferring prescription data from a personal computer:
Timeout on Data Receiving.

If the connection between the PHOENIX machine and the personal computer is
interrupted while transferring prescription data:
Connection lost with Clinical SW.

Press CONFIRM to Proceed
Rev. B
The operator must press the CONFIRM button to proceed the treatment; all of the
patient prescription will be discarded.
WARNING
The PHOENIX machine can be programmed by receiving data through
connections to various external devices. As soon as PHOENIX reads the data, it is
displayed on the Touch Screen. It is the responsibility of the user to verify all the
data before confirming it is correct. Some important parameters relating to the
safety of the patient are shown twice, in alternative ways, on the Touch Screen. It
is necessary to pay close attention to these values and check their congruency.
Rev. B
7.6 Communication Libraries

Some information libraries (e.g. Patient Events) are stored in a dedicated memory
section of the PHOENIX system.
This data can be either downloaded or uploaded to/from the PHOENIX with
dedicated application software.
The file transmission can be performed only when the PHOENIX is in the IDLE state.
During this transmission, the PHOENIX control panel is disabled and the user is
informed accordingly on the Touch Screen.
The modifications to the library apply when the PHOENIX machine is subsequently
powered ON.
Rev. B
7.7 CentryNet System Connection
The CentryNet network consists of a series of CentryNet capable dialysis machines

(PHOENIX, Centrysystem 3) with RS485 Network Interface Cards. The RS485
interface cards contain the necessary circuitry to receive incoming information from
and transmit dialysis treatment data back to the network controller.
Understanding the CentryNet system involves understanding what the CentryNet

controller does, how it performs, how it communicates, and how the collection of
treatment data is managed when using the CentryNet software.
PHOENIX
CentryNet
Wall
Outlet
Host Computer (Optional)
Network 1 CentryNet
(Max 32 Machines) Wall
Outlet
Network 2 (optional)
Network Controller
Centrysystem 3
CentryNet
Wall
Outlet
Termination
Printer (Optional) Assembly
Typical CentryNet Network Configuration
Rev. B
7.7.1 What CentryNet Does

With the CentryNet option, PHOENIX machines are cabled together for
communication with a network controller, a specially configured computer that
collects, sorts and stores data generated by the PHOENIX machine during the dialysis
treatment. This data is organized into a Treatment Record run sheet format and can
be sent to a printer, a host computer system, or both.
After the operator presses the START COLLECT Action key, treatment data is
collected (as taken) for the following information:
Machine SETUP parameters, e.g., at START COLLECT, and whenever the

machine enters DIALYSIS.
Changes that may occur in the machine SETUP.
Machine status changes, i.e., when a PHOENIX machine goes ONLINE or

OFFLINE, or when the CentryNet controller is started up or shut down.
All REPORTS and BPM data.
Several functions initiate a reading of PHOENIX machine data:
Blood pressure readings taken at selected timed intervals.
The blood pressure monitor fails to record a requested reading.
The Heart button on the Main Control Panel is pressed.
The machine is taken into or out of the DIALYSIS mode.
Automatic readings taken at selected timed intervals.
The CHARTS Action key is pressed.
During DIALYSIS, the CentryNet controller automatically collects data without

operator assistance or intervention. The end data collection event takes place either
when the operator presses the STOP COLLECT Action key or automatically at the
Patient Login event for the following treatment. At the end data collection event the
CentryNet controller stops collecting data for that treatment and the treatment is
summarized and closed out on the network controller.
If for any reason the operator does not press the START COLLECT and STOP
COLLECT Action keys on the PHOENIX machine in the required sequence, or if data
collection is interrupted for any mechanical reason, the treatment data collection may
be prematurely concluded. The CentryNet-collected data for such a treatment will be
incomplete, e.g., the treatment will be broken.
When the PHOENIX machine is between treatments, the CentryNet controller
collects no treatment data. Therefore, the operator should remember not to perform
any therapy-related, data-generating tasks between treatments.
Rev. B
7.7.2 How CentryNet Communications Work

When using the CentryNet option with PHOENIX system, the PHOENIX collects and
stores treatment data and ultimately transfers the data to the network controller along
the cabling that links the network controller and the dialysis machines.
A series cable connects all the PHOENIX machines on a network. In this type of
network the network controller can only communicate with, or poll, one machine
at a time.
The physical location (the STATION ID) of a PHOENIX machine within a clinic
determines the order for communication between the CentryNet controller and the
PHOENIX units.
The CentryNet controller collects data based upon the following:
The ID SET: Unique data identifiers (per machine) that include theSTATION ID,
CCM IDENTIF, PATIENT ID, and a sequence number to identify data with a
specific treatment.
The START COLLECT and STOP COLLECT Action keys initiate and close out
the sequence number, which identifies specific treatment information with a
particular machine (ID Set).
Note
The sequence number - invisible to the operator - corresponds to the chronological
sequence of treatment data and will change only when a new treatment is started.
When the operator presses the START COLLECT Action key on the PHOENIX
machine, and after the PATIENT ID value is confirmed, all four data identifiers
(STATION ID, CCM IDENTIF, PATIENT ID, and the sequence number) are sent to the
network controller and logged in. All treatment data generated for this treatment will
contain these four data identifiers. If any of these identifiers are changed during a
treatment, the network controller considers the treatment broken, or prematurely
ended.
If the CentryNet controller does not poll the PHOENIX machine at least once during
the time established by the OFFLINE TIMEOUT setting, the PHOENIX machine will
display an alarm indication,CentryNet Station Offline. The operator may not start or
end data collection when this message is displayed, however, treatment data already
collected in the network controller will be retained.
Note
The installation technician sets the CCM IDENTIF and the OFFLINE TIMEOUT limit within
the PHOENIX machine at installation.
Rev. B
7.7.3 Operator Tasks and Guidelines for CentryNet

The basic tasks the operator performs directly at the PHOENIX machine are:
Verify the physical location of the PHOENIX machine (theSTATION ID)
Perform the Patient Login (LOGIN Action key selection).
Press the START COLLECT Action key on the PHOENIX machine to start data
collection for a treatment.
Enter a unique PATIENT ID using the alpha-numeric keypad, and confirm.
Note
The PATIENT ID value cannot be inserted prior to the Patient Login event.
Conclude the treatment

Press the STOP COLLECT Action key to manually end data collection for a
treatment.
Login the next patient, i.e., select and confirm a new Patient/RX Dialysis,
press LOGIN, or select PAT CONNECT (in Standard Dialysis).
Note
Post Treatment measurements can be taken until the next Patient Login event.
A few simple rules aid the clinician when using the CentryNet option:
1. Perform only those tasks between treatments for which data is neither required
nor expected.
2. Always press the LOGIN Action key and enter a new PATIENT ID for each patient
to start the collection of data for a treatment.
3. Always conclude the treatment in the normal fashion (see above).
Note
Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first
pressing STOP COLLECT. Doing so will cause the treatment in CentryNet to be broken.
Any data acquired will be transferred to Broken Treatments and unavailable in the
Treatmens database in CentryNet.
Note
When data collection for a treatment terminates, the CentryNet network controller begins
collecting data again for that machine only when the operator presses the PATIENT ID
Action key.
Note
Switching the CentryNet option Off ends data collection - breaking the treatment.
Rev. B
7.7.4 Configuring the unit with the CentryNet option

To configure the PHOENIX machine for operation with CentryNet, from the Home
view (in IDLE view) press the Config Navigation key. The following view will be
displayed:
12:30
IDLE
CONFIG MACHINE CENTRE ADR TREATME PROFILE KT/V

CONF NTS
Rev. B
Press the MACHINE Navigation key, the Communic. Navigation key, then press the
SET button on the Main Control Panel to access the SET Mode. The following view
will be displayed:
12:30
IDLE
CCM IDENTIF
50
SW COMM SYSTEM AUTOCHART TIME OFFLINE TIMEOUT
CentryNet 00:30 01:30

min:s min:s
IP ADDRESS 1st t IP ADDRESS 2nd IP ADDRESS 3rd IP ADDRESS 4th
50 20 10 50
SUBNET MASK SUBNET MASK 2nd SUBNET MASK 3rd SUBNET MASK 4th
50 10 10 20
For CentryNet, the important items to verify are:
CCM IDENTIF Machine Identifier

SW COMM SYSTEM System type
OFFLINE TIMEOUT Polling Timer
AUTOCHART TIME Automatic interval
CCM IDENTIF
CCM IDENTIF is used to set the Machine Identifier for CentryNet. The CCM IDENTIF
for each PHOENIX machine in a clinic must be a unique three-digit number, between
1 and 250. Pressing this parameter box activates the PLUS and MINUS buttons on
the Main Control panel, and allows the user to increase or decrease the CCM
IDENTIF.
The PHOENIX CCM IDENTIF must be set at installation - without it, the CentryNet
system will not communicate with the machine. This ID does not normally change
throughout the use of the machine. A record of CCM IDENTIFs for each clinic should
be kept so that new CCM IDENTIFs do not duplicate any existing ones.
Rev. B
SW COMM SYSTEM
This parameter box activates a sub-view with several selections on it. These items
allow the user to select a destination for the data. It must be set to CentryNet for the
CentryNet system to communicate with this machine.
OFFLINE TIMEOUT
The Polling Timer: A defined period of time during which the CentryNet network
controller must communicate with each machine. Pressing this parameter box
activates the Plus and Minus buttons on the Main Control panel, allowing the user to
select an appropriate timeout setting.
Use the following formula:
Time = 90 or (Number of stations x 5), whichever is greater
Example 1: There are 15 machine stations in the network. Insert this value (15) into
the formula. The timeout setting calculates to be (15 x 5), or 75.
75 is the value that would normally be used for all machines on the network.
However, a minimum of 90 is recommended, therefore, use 90 in each.
Example 2: There are 30 machine stations in the network. Insert this value (30) into
the formula. The timeout setting calculates to be (30 x 5), or 150.
150 is the value to be used in all machines on this network.
Note
Do not set the polling timer to a value lower than the recommended default setting of 90.
You may, however, set the polling timer to a higher value allowing more time before the
Station Off-line alarm occurs. If you set it at too short of a time span, it may cause the
PHOENIX to go into alarm as it goes off-line and online. The polling time must be set in
the machine at installation to avoid unnecessary alarms.
AUTOCHART TIME
The AUTOCHART TIME parameter box allows the user to select when readings will
be taken automatically for CentryNet; the time between REPORT readings. REPORT
readings are a snapshot of the machines operation at that moment. Pressing this
parameter box activates PLUS and MINUS buttons on the Main Control Panel,
allowing the user to select an appropriate time interval setting.
Note
The system also takes a REPORT reading according to the Blood Pressure Module sample
interval. See the Section 5.C - Blood Pressure Monitoring, in this manual, for the
procedure to configure the SAMPLE INTERV.
Rev. B
7.7.5 CentryNet Option Screen Setup Keys

The CentryNet option, when active, is accessed by first pressing the Report
Navigation key, and then pressing the CentryNet Navigation key.
12:30
PATIENT ID STATION ID
0 0
CENTRYNET USE CCM IDENTIF

YES 50
REPORT CENTRYNET
Press the SET button on the Main Control Panel to enter the SET Mode.
12:30
IDLE
CENTRYNET USE STATION ID
YES 0
Rev. B
CENTRYNET USE
The CENTRYNET USE parameter box allows the operator to activate or deactivate the
CentryNet option. When the option is set to YES (ON), the CentryNet data collection
function is active and begins immediately when the START COLLECT Action key is
pressed.
When the CENTRYNET USE option is set to NO (OFF), data collection does not take
place and all CentryNet alarm signals are deactivated. The CentryNet option can be
switched OFF at any time during the treatment. Switching from ON (YES) to OFF
(NO) abruptly interrupts data collection relating to the treatment in progress. The
CentryNet option can be switched ON at any time except when the machine is in the
Dialysis mode, i.e., activating the CentryNet option during Dialysis is disallowed.
STATION ID
The STATION ID parameter box allows adjustment of the STATION ID for the
machine. Pressing this box activates the PLUS and MINUS buttons on the Main
Control panel. These buttons allow the user to increase or decrease the STATION ID.
Values from 1 to 255 may be selected.
The STATION ID is typically the number assigned to the physical location (the station)
within the facility. The value entered into the PHOENIX must correspond to this
location. If the unit is moved within the facility, a new STATION ID must be entered
to allow the system to correctly proceed with the station assignment.
Upon power up, the PHOENIX machine always assumes the value previously
assigned for the STATION ID. Station assignment for the PHOENIX machine is
automatic with CentryNet - the STATION ID must be present as one of the active
stations in the network controller. If the PHOENIX machine has a valid STATION ID
present in memory, when CentryNet polls that station the PHOENIX machine will
respond automatically, no operator action is required.
The STATION ID parameter box may not be present when first entering the SET
Mode. To activate the parameter box, switch the CENTRYNET USE parameter box
from YES to NO. The STATION ID key will now be present. The STATION ID may
only be changed when the CentryNet option is Off; CENTRYNET USE=NO.
CCM IDENTIF
CCM IDENTIF is used to set the Machine Identifier for CentryNet. The CCM IDENTIF
for each PHOENIX machine in a clinic must be a unique three-digit number, between
1 and 250.
The PHOENIX CCM IDENTIF is accessed (from the IDLE view) by pressing the Config
Navigation key, then the MACHINE Navigation key, and then the Communic.
Navigation key. Finally, press the SET button on the Main Control Panel to enter the
SET Mode.
PATIENT ID
The PATIENT ID can be a number from 0001 to 9999. Each patient should have his or
her own unique ID.
Once the desired PATIENT ID is entered it is possible to start data collection. The
PATIENT ID may not be changed after start of data collection. It may be changed only
after the treatment has been terminated. The PATIENT ID entry keypad may be
accessed through the REPORT screen.
Rev. B
7.7.6 Communication Icons relating to the state of the network link

Several icons are associated with CENTRYNET USE. The following icons indicate the
state of the CentryNet option:
Use = NO Use = YES Use = YES
CentryNet is Off CentryNet = On CentryNet = On

Station = Offline Station = Online
(When data is available,
icon is yellow and flashes)
CENTRYNET OFF
The CENTRYNET OFF icon appears when the CentryNet option has been
deactivated. While this message is displayed, no communication with CentryNet
takes place, and, all CentryNet alarms are deactivated. When the option is activated
the CENTRYNET OFF icon is replaced by one of the following.
CENTRYNET ON / STATION OFFLINE

The STATION OFFLINE icon appears when CentryNet is active but communication
between the network controller and PHOENIX does not occur, or when the
PHOENIX machine has not received a communication within the established time
limit for the Offline Timeout (polling timer). This icon warns the operator that there is
no communication and data is not being collected by the network controller.
CENTRYNET ON / STATION ONLINE

The STATION ONLINE icon appears when the CentryNet option is active and
effective communication is in progress. The icon indicates that the machines
STATION ID and CCM IDENTIF are accepted by CentryNet.
When there are records to be taken by the CentryNet network controller, this icon is
yellow and flashes until the controller has successfully taken all records.
Note
A machine assignment must take place when a specific machine ID does not match the
list in CentryNet. This must be accomplished before data collection can begin. The
assignment function takes place automatically when the PHOENIX machine and the
CentryNet network controller begin communicating after (the machine has just been
turned on and) a STATION ID has been entered. Data from an incorrectly assigned
station is not collected. The PATIENT ID Action key is disabled until the station is
successfully assigned.
Rev. B
7.7.7 Operator Keys relating to the state of the treatment

There are several Action keys that control when data is being collected.
LOGIN
START COLLECT/PATIENT ID entry keypad
STOP COLLECT
The Report screen provides access to these Action keys.
Clk VEN P ART P BFlow Time Syst Dias HRAT EVENT DESCR QTY UNIT LOGIN
Time E
-- -- -- PRE STANDING MEAS

PATIENT ID
-- -- -- PRE LYING MEAS
-- -- -- PRE SITTING MEAS

STOP COLLECT
CHARTS
LOGIN
This action key (event) performs several functions for the communication system.
It initiates the Patient Login event and clears previous data in the Report
screen.
It enables the PRE-/POST- data-handling feature of the BPM system.
If not already concluded, it closes out (ends) the current treatment registered
in CentryNet (as if the STOP COLLECT Action key had been pressed).
It allows the user to initiate a new treatment in CentryNet by activating the

START COLLECT Action key and the PATIENT ID entry keypad.
Rev. B
Note
The Patient Login event is triggered automatically by pressing an PATIENT DATA
Selection key in Patient/Rx dialysis, or by pressing the LOGIN Action Key in a Standard
dialysis. . If an Rx selection key has been pressed the LOGIN Action key is not displayed
the START COLLECT Action key will be displayed.
START COLLECT
Pressing the START COLLECT Action key activates the PATIENT ID entry keypad.
It is normally available in all modes exceptIDLE, TREATMENT and ADR PROGRESS.

However, the START COLLECT Action key is not available for the following:
The Patient Login event has not been triggered.
The STOP COLLECT Action key has not been pressed.
If any CentryNet alarms exist on the PHOENIX system.
PATIENT ID Keypad
After pressing the START COLLECT Action key, a keypad appears allowing the entry
of the PATIENT ID.
123
<< Clear >>
7 8 9
4 5 6
1 2 3
BackSpace 0
Enter the ID number through the keypad and press the CONFIRM button on the
Main Control panel to confirm. The PATIENT ID can be any number from 0001 to
9999. Once the PATIENT ID is entered data collection begins. Pressing CONFIRM
clears the treatment database in PHOENIX machine, begins the collection of
treatment data to the network controller, and assigns the data to the PATIENT ID for
that treatment.
Note
The PATIENT ID may not be changed after the start of dialysis. It may, however, be changed
before dialysis has been initiated. If a new PATIENT ID is required press the STOP COLLECT
Action key, the LOGIN Action key, the PATIENT ID Action key, and then enter the new ID
through the keypad and press confirm. The PATIENT ID may also be changed after the
treatment has been terminated, i.e., data collection has been ended, for this patient - follow the
standard procedure for setting up a new patient.
Rev. B
STOP COLLECT
The STOP COLLECT Action key stops data collection and ends the treatment in
CentryNet. It appears after the PATIENT ID has been entered and data collection has
begun. It is not available if any CentryNet alarms exist on the system.
This key may be pressed to manually conclude collecting data for a particular
treatment (PATIENT ID), or the operator may conclude the treatment automatically by
setting up for the next patient, i.e., by pressing an Patient/Rx Management patient
selection key, pressing the LOGIN Action key, or pressing the PAT CONNECT Action
key.
Note
Do NOT turn OFF the machine without first pressing STOP COLLECT. Doing so will cause
the treatment in CentryNet to be broken. Any data acquired prior to the power-off will be
transferred to Broken Treatments and unavailable in the Completed Treatments database
in CentryNet..
Note
Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first
pressing STOP COLLECT. Doing so will cause the treatment in CentryNet to be broken.
Any data acquired prior to returning to IDLE will be transferred to Broken Treatments and
unavailable in the Completed Treatments database in CentryNet.
Note
After STOP COLLECT and before PATIENT ID the PHOENIX is considered between
dialysis treatments. Whenever the CentryNet option is turned OFF, the machine is also
between treatments. The CentryNet controller does not collect treatment data from a
machine when it is in this mode
Note
The STOP COLLECT Action key is made available if certain conditions in the treatment
are met. One condition includes a successful polling (status response) communication
between the PHOENIX machine and the CentryNet software. Another requires that all
records from the treatment in progress have been collected by CentryNet.
As a consequence, the availability of the STOP COLLECT Action key may be delayed
under some conditions, for example, the STOP COLLECT Action key might become
available only after the completion of the CentryNet polling loop and the downloading of
all charts and related records from the PHOENIX machine.
Rev. B
7.7.8 Operator Keys relating to manual data collection

There is one additional Action key that controls when data is collected.
CHARTS
CHARTS
Pressing the CHARTS Action key triggers a chart record to be generated and sent to
CentryNet. This chart record is identical to those automatically generated by the
machine, as defined by the time established in the AUTOCHART TIME interval.
Note
The system also takes a CHART reading according to the Blood Pressure Module sample
interval. See the Blood Pressure Monitoring section of this manual for configuring the
SAMPLE INTERV.
Rev. B
7.7.9 Alarm signals relating to CentryNet

Several alarms may be generated regarding the CentryNet option.
The CentryNet Station Offline (#322) alarm indicates a communication problem

in the network, i.e., PHOENIX machine cannot detect communications.
The CentryNet: Incomplete Data Collection (#323) alarm may occur if the
CentryNet network controller has not received all records from the PHOENIX
machine and an attempt to end the treatment has been made.
The CentryNet: Duplicate Station (#321) alarm will occur whenever one of the
STATION IDs is duplicated on more than one machine in the network.
The CentryNet: Station ID Error (#325) alarm indicates that a problem exists with
the STATION ID assignment for a particular machine.
Note
See Section 8 - Alarms and Signals in this manual for a detailed description of these alarms:
Reason for Alarm, Machine Actions, Possible Causes/Suggested Action.
Whenever the PHOENIX machine displays any CentryNet-related alarms during a

treatment, data collection is suspended. However, data is not lost if the alarm-causing
situation is corrected without breaking the treatment.
Background Information for Investigating CentryNet Alarms
Communication in the CentryNet network occurs as following:
1. Initial Reception - consists solely of the PHOENIX machine being able to detect
communication on the network. When the PHOENIX machine successfully
detects communication the CENTRYNET STATION OFFLINE message is masked.
2. Machine Assignment - consists of the PHOENIX machine being able to send out
an assignment request and correctly interpret the network controller's response. If
received successfully, the station assignment is accepted and the PHOENIX
machine automatically comes Online. At that point the STATION ONLINE icon
will display and the STATION ID ERROR message is masked.
3. Data Collection - consists of full interaction, with the network controller requesting
specific data from the PHOENIX machine and acknowledging the transmissions.
It provides detailed information about status, parameters, and current charts data.
For additional information see the CentryNet Operators Guide.
Rev. B
7.7.10 CentryNet option activation/deactivation after a Fast Recovery

of the Dialysis process
In case of dialysis treatment interrupted and then restarted with a Fast Recovery of the
Dialysis process procedure, the operator can
either start a new treatment data collection session for the same patient
or deactivate the CentryNet option and continue the dialysis treatment without
recording treatment data.
Starting a new data collection session
Perform the following procedure to start a new treatment data collection session for
the same patient and to restart the interrupted treatment:
Press the SETUP Action key

Follow the directions in the Operator Message Window:
The machine will immediately go to the PATIENT CONNECT mode.

Press the Blood Pump ON/OFF button to start the Blood Pump.
Reset the TOT WEIGHT L, DIALYSIS TIME and the WEIGHT LOSS/H using the
SET mode.
From the Report\CentryNet view, press the PATIENT ID Action key and enter
thePATIENT ID. Press the Confirm button.
Select the DIALYSIS Action key on the PATIENT CONNECT view.
Note
After a Fast Recovery of the Dialysis process, if the CENTRYNET USE parameter value is
set to YES, the DIALYSIS Action key becomes available only after properly entering the
PATIENT ID.
Deactivating the CentryNet option
Perform the following procedure to deactivate the CentryNet option and to restart
the interrupted treatment without recording treatment data:
Press the SETUP Action key

Follow the directions in the Operator Message Window:
The machine will immediately go to the PATIENT CONNECT mode.

Press the Blood Pump ON/OFF button to start the Blood Pump.
Reset theTOT WEIGHT L, DIALYSIS TIMEand the UFR using the SET mode.
From the Report\CentryNet view, enter in Set mode and set the CENTRYNET
USE parameter value to NO. Press the Confirm button.
Select the DIALYSIS Action key on the PATIENT CONNECT view.
Rev. B
Note
After a Fast Recovery of the Dialysis process, the DIALYSIS Action key becomes available
only after setting the CENTRYNET USE parameter to NO.
Re-activating the CentryNet option during the same dialysis treatment
If the CentryNet option has been deactivated, it can be reactivated, during the same
dialysis treatment by performing the following procedure:
Press the WASHBACK Action key on the TREATMENT view and then press the
Confirm button.
Enter in the Report\CentryNet view and press the SET button on the Main
Control Panel to enter the SET Mode.
Select the CENTRYNET USE parameter box and set the parameter to YES, then
press the Confirm button.
From the WASHBACK view, press the TREATMENT Action key to continue the
dialysis treatment with a new treatment data collection session for the same
patient.
Note
When the RINSEBACK VOLUME value set has been reached, the DIALYSIS Action key
disappears from the WASHBACK view and it is no longer possible to return to dialysis.
Rev. B
8 ALARMS AND SIGNALS
8. SECTION 8 - ALARMS AND SIGNALS
8.1 Classification and modes of intervention

The machine has been designed to recognize and control various types of malfunctions and
faults. There are three ways in which the operator is advised of an alarm condition:
Modulated audible alarm, high or low tone.
Visual alarm with a flashing light at the top of the machine.
Message in the alarm window on the Touch Screen with a description of the alarm.
The alarms are classified according to the part of the machine affected and the type of
intervention required from the operator.
All the alarms are indicated in the alarm window on the Touch Screen, while the type of visual
and audible alarm depends on the class of alarm.
Note
Depending on the version of the buzzer installed on the machine, the tone of the audible alarms
may be:
High or Low: for machines in which the Standard buzzer is installed;
Only High: for machines in which the Magnetic buzzer is installed.
To install and configure the machine for the use of the Magnetic buzzer a service intervention is
required.
Refer to CLASSES OF ALARMS in this section, for the detailed description of the audible alarm
type depending both on the class of the alarm and on the version of the buzzer.
WARNING
If more than one alarm occurs at the same time, the control system automatically prioritizes
them, relative to existing alarms.
Only those alarms which describe the presumed cause of malfunction are displayed in the
alarm window.
Alarms that are generated as a result of the original malfunction are not displayed in the
alarm window.
The classes of Alarms will be described in decreasing order of importance, i.e the first is the
most serious type of alarm.
CLASSES OF ALARMS
P Alarms related to the safety of the patient, which may be controlled by the machine or by
the intervention of the operator as described below. They may be identified by:
A Visual alarm with a flashing Red light of 4-4 modulation (one flash of 4/8 second,
followed by a 4/8 second pause).
An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone.
A Message on top of the Touch Screen preceded by an exclamation (!) mark.
Rev. B
Note
Some class P alarms have a descriptive "attribute", which specifies the type of fault.
Pd Alarms not related to the safety of the patient, which are due to an error in the reading of
process data contained in the memory of the Protection Module. These require operator
intervention as described below. They may be identified by:
A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one
flash of 4/8 second, followed by a 4/8 second pause).
A Message on the top of the Touch Screen preceded by an exclamation (!)
mark and followed by the words: data error.
A Alarms not related to the safety of the patient, caused by internal machine processes,
requiring operator intervention to remove the cause, returning the process data to
the operating limits. They may be identified by:
A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one
flash of 4/8 second, followed by a 4/8 second pause).
A Message on the top of the Touch Screen.
B Alarms not related to the safety of the patient, caused directly by an operator error
on the machine controls or caused by machine conditions requiring operator
intervention. These require operator intervention. They may be recognized by:
A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a
flash of 1/8 second followed by a pause of 7/8 second).
An Audible alarm with a 1-7 modulation that has a low pitch if the Standard
buzzer is installed or that has a high pitch if the Magnetic buzzer is installed,
modulated tone.
W Indication of disturbances not related to the safety of the patient and due to
conditions not recognized by the Protection Module. These disturbances may revert
to normal without operator intervention. They may be identified by:
flash of 1/8 second followed by a pause of 7/8 second).
An Audible alarm with a modulation of 1-7 and a high pitch, modulated tone.
A Message on the top of the Touch Screen, preceded by W!
E Alarms which are not related to the safety of the patient, and are caused by control
errors that may revert to normal without the need for operator intervention. They
usually require the intervention of a Service technician. They may be identified by:
flash of 1/8 second and followed by a pause of 7/8 second).
Audible alarm with a modulation of 1-7 and a high pitch, modulated tone.
A Message indication on the top of the Touch Screen.
Rev. B
SECTION 8 - ALARMS AND SIGNALS 8-3
D Indication related to a machine state requiring the attention of the operator. These
are not related to the safety of the patient or to an error condition.
They may be identified by:
A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash
of 1/8 second followed by a pause of 7/8 second).
An Audible alarm with a modulation of 1-7 and a low pitch if the Standard buzzer
is installed or that has a high pitch if the Magnetic buzzer is installed, modulated
tone.
C Alarms which are not related to the safety of the patient and are due to transitory
control errors which usually revert to normal without operator intervention. If these
errors persist, the machine is probably not functioning properly and Service must be
notified. They may be identified by:
A Visual alarm with Yellow light with a flashing pattern of 1-7 modulation (a flash of
1/8 second followed by a pause of 7/8 second).
The operator can therefore identify the class of alarm with the aid of the three types of
indicators available and then take appropriate action.
Note
All the alarms are coded numerically. The relevant code is displayed on the Touch Screen with the
alarm message.
Note
The PHOENIX machine is able to send a signal to a remote alarm device, to indicate an audible
alarm, only in case of occurrence of alarms in the classes P, Pd, A, W, E.
LEVELS OF OPERATOR INTERVENTION

When an alarm condition occurs, the operator may be able to manually deal with the
problem, depending on its class.
The specific actions to take are described for each individual alarm. Three types of intervention
are possible:
1) OVERRIDE
When an alarm is activated, the operator can try to solve the problem by stopping the
autonomous operations being carried out by the machine and reaching a specific safe state.
This can be done by pressing the OVERRIDE button on the Main Control Panel.
When the LED on the OVERRIDE button comes on, release the OVERRIDE button.
During the OVERRIDE state, the LED is on.
Rev. B
The OVERRIDE state lasts 2 minutes.
During this period:
Some of the safety mechanisms are disabled (as pointed out in the description of each
alarm).
The Audible alarm stops.
The Visual alarm remains ON as long as the fault persists.
The Message remains on the Touch Screen with the description of the cause of the alarm.
The Message is preceded by the icon representing the OVERRIDE condition:
! Venous Pressure
Every 20 seconds the Audible and Visual alarms are repeated.
If one or more additional faults cause an alarm during the OVERRIDE state, the description
relative to each fault is added to the superimposed window.
In this case the operator can intervene with the OVERRIDE button. All the new alarms are set
to the OVERRIDE state.
The timer relative to the duration of the OVERRIDE state is reset to zero each time the button
is pressed so this state remains for 2 minutes from the last time the button was pressed.
OVERRIDE is removed:
Automatically when the time has elapsed.
Manually before the time has elapsed, by pressing the OVERRIDE button until the LED
goes off and then releasing the button.
When the OVERRIDE state has been removed, any remaining alarms are reactivated, along
with their respective descriptive messages.
Note
In some specific alarm cases, the OVERRIDE button has different effects. The alarm condition is
RESET and the alarm message disappears from the screen. These cases are marked with in the
following list.
Note
The selection of the OVERRIDE button has no effect on the alarms that occur while the machine
is performing one of the following T1Tests: Board CPU, EPROM CRC, Comparator, Board RAM,
Battery, Buzzer Lamp, Voltages (24V), Venous Clamp.
WARNING
The selection of the OVERRIDE button has effect on all the alarms that are active and can
be set to the OVERRIDE state (refer to the Alarms List in this section for the list of
alarms that can be set to the OVERRIDE state). In the Alarm Area of the screen only two
alarm messages can be displayed; if there are more than two alarms active, the additional
alarms may be viewed on the Machine view by pressing the Machine Navigation key.
Rev. B
WARNING
During OVERRIDE, the user is responsible for monitoring the parameters that are being
overridden.
2) MUTE
By pressing the MUTE button on the Main Control Panel, the operator can temporarily (2 min)
deactivate the audible alarm.
During the MUTE state:

The LED on the MUTE button remains on.
The Audible alarm is deactivated.
The Visible alarm remains.
The message remains on the Touch Screen with the description of each alarm.
The MUTE state is removed:

Automatically when the time has elapsed.
Manually by pressing the MUTE button until the LED starts to flash.
When a new alarm is activated.
3) RESTART
In certain alarm conditions, the view relative to the current phase of the process disappears
from the Touch Screen and the RESTART key becomes available to allow an exit from the
alarm condition.
A suggestion on how to solve the problem appears in the Operator Message area.
When the fault has been removed and RESTART pressed, normal operation is resumed. The
current view reappears on the Touch Screen.
WARNING
If the first time the RESTART key is selected, the machine returns to the RESTART condition,
wait at least ten seconds before pressing the RESTART key again.
WARNING
In some Protection alarms, the audible alarm is active only after DIALYSIS is initiated.
WARNING
Press the RESTART key only after having removed the cause requiring the RESTART, as
described on the Touch Screen. Never press the RESTART key more than 2 or 3 times if the
problem has not been identified that will remove the cause of RESTART.
Rev. B
8.1.1 Operator Guidelines for responding to Alarms on the PHOENIX

machine
In case of an alarm condition, the Operator should perform the following actions:
1. Press the MUTE Button to silence the Audible Alarm, if desired.
2. Observe the Alarm Message in the Alarm Area at top of the Touchscreen. Alarms are
referenced by number. The number is located on the Right Side of the Alarm Message.
3. Determine the cause of the Alarm. If uncertain about the cause or appropriate
response to the alarm, refer to Alarms Troubleshooting, in this section, for possible
causes and solutions.
4. Correct the cause of the Alarm and then press the OVERRIDE Button. The Alarm or
Alarms that are present will be overridden for 2 minutes.
5. In some cases it may be necessary to restore the previous operating conditions to

properly troubleshoot an Alarm. In these cases the OVERRIDE Button may be pressed
prior to correcting the cause of the Alarm.
WARNING
During OVERRIDE, the user is responsible for monitoring the parameters that are being
overridden.
Note
For some Alarm Conditions a RESTART Key will appear on the Touchscreen. These Alarms are
cleared by pressing the RESTART Key, rather than pressing the OVERRIDE Button.
Note
If the Overridden Alarms reoccur during the 2-minute OVERRIDE period they will not
cause a new Alarm.
Note
If other new Alarms occur during the OVERRIDE period, the PHOENIX machine will
generate audible and visual alarms.
Note
Each time the OVERRIDE Button is pressed the OVERRIDE period is reset to 2 minutes.
Rev. B
8.1.1.1 OVERRIDING Arterial and Venous Pressure Alarms
Following an Arterial or Venous Pressure Alarm (code #155 and #305), pressing the
OVERRIDE Button will restart the Blood Pump at the previous speed. During the OVERRIDE
period, the overridden Arterial and/or Venous Pressure Alarms will not recur until the 2-minute
period has elapsed.
However, after 30 seconds the previously memorized alarm windows will be displayed on the
Pressure Bar Graphs. If the Pressure Pointers move outside of the alarm windows, the
corresponding alarm messages and the Override Icon will be displayed in the Alarm Area. The
Blood Pump will continue to operate because the Alarms are in an Override condition. An
audible alarm will also occur, if it has not been previously muted. When the Pressure Pointers
return within the alarm windows the alarm messages will no longer appear.
Additional, supplementary Arterial and Venous Pressure Limit Alarms are always present and
active:
! ART PRESSURE LIMIT (code #306), which occurs when the pressure reaches the
value set for the MIN ART PRESSURE parameter.
! VEN PRESSURE LIMIT (code #154), which occurs when the pressure reaches
the value set in the Configuration Menu for the VEN PRES LIMIT parameter.
However the Operator must consider that during the time when the Arterial or Venous
Pressure Alarms are OVERRIDDEN and before an ! ART PRESSURE LIMIT#306 alarm, or a
! VEN PRESSURE LIMIT #154 alarm occurs:
The patients vascular access may be exposed to pressure extremes.
Restriction of blood flow to the Arterial Chamber may result in emptying of the
Chamber prior to the Redundant Alarm occurring.
WARNING
It is the Operators responsibility to determine and to correct the cause of the Arterial or
Venous Pressure Alarm (#155 and #305) PRIOR to pressing the OVERRIDE Button.
Note
Pressing the OVERRIDE button will spread the alarm windows for 30 sec.
Rev. B
8.1.1.2 Operator Actions required after pressing the OVERRIDE Button for Arterial and
Venous Pressure Alarms
After pressing the OVERRIDE Button the Operator should remain at the machine and
observe the Arterial and Venous Pressure Pointers.
The Operator should also wait for the memorized Arterial and Venous Pressure Alarm
Windows to reappear around the Pressure Pointers and then determine if the needle position,
the Blood Pump speed or the alarm windows are appropriate.
If required, the Arterial or Venous Alarm Windows may be adjusted by pressing the SET
Button and then highlighting the appropriate Pressure Bar Graph. The CONFIRM Button is
then pressed to adjust the Alarm Windows, followed by pressing the SET button to return to
the Home Screen. The newly memorized alarm widows will appear around the pressure
pointers.
If the pressures are stable and within the alarm windows the Operator may press and hold the
OVERRIDE Button until the orange LED to the right of the button is no longer illuminated. This
will cancel the Override condition. Alternatively the Operator may observe the machine until
the 2-minute Override period is completed.
8.1.2 Alphabetic List of Alarms

Below is a list of all the alarms in alphabetic order, indicating:
The message that appears on the Touch Screen.
The Attribute (if any)
The Numerical Code
The Class
The OVERRIDE button availability
Rev. B
ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE
! AIR & FOAM DETECTOR 4 AIR BUBBLE P YES

T0 FAILURE PARTIAL
! ART PRESSURE ALARM 305 MAXIMUM P YES
MINIMUM
UNDEFIN
! ART PRESSURE LIMIT 306 P NO
! ARTERIAL PUMP 10 MAXIMUM P YES

MINIMUM
UNDEFIN
LINE PRES
! AUTOEMPTYING: MAX ACTIVATION TIME 294 P YES
! BIC CONDUCTIVITY 23 MAXIMUM P NO

MINIMUM
! BLOOD DETECTED DURING PRIME 342 P NO
! BLOOD LEAKAGE 28 P YES
! BLOOD PUMP DIRECTION 340 P YES
! BYPASS WRONGLY EXTENDED 302 P NO
! CONCENTRATE CANS 40 HIGH PH P NO

LOW PH
A PUMP
B PUMP
A+B PUMPS
! CONDUCTIVITY PROFILE 210 CURVE P YES
TIMING
SET VAL
! CONTROL SYSTEM OUT OF ORDER 274 P NO
! DIALYSATE FLOW 44 MAXIMUM P YES

MINIMUM
UNDEFIN
! DIASCAN MEASUREMENT FAILED : 251 P YES
! FINAL CONDUCTIVITY 62 MAXIMUM P NO

MINIMUM
! PI PO MAX 114 P NO
! PI PO MIN 115 P NO
! PROTECTIVE CARD COMM. TIMEOUT 120 P NO
! PROTECTIVE MSG TRANSFER ERROR 39 PD NO
! SN COMMUTATION 125 P YES
! T1 TEST FAILED 133 P NO
! TEMPERATURE 134 MAXIMUM P NO

MINIMUM
UNDEFIN
Rev. B
! TEMPERATURE EXCESSIVE VALUE 136 P NO
! UF MASS BALANCE 144 VALVES P YES

D1-2/P2
NO CALIB
! UF RATE ERROR 145 LOW P YES
HIGH
VESSEL
! VEN PRESSURE ALARM 155 MAXIMUM P YES
MINIMUM
UNDEFIN
! VEN PRESSURE LIMIT 154 P YES
PARTIAL
SEE NOTE 2
! VOLTAGES INCORRECT 160 P NO
! WEIGHT LOSS RATE PROFILE 212 CURVE P YES

TIMING
SET VAL
!ART PRESSURE DATA ERROR 307 PD NO
!AUTOEMPTYING DATA ERROR 277 PD NO
!BICARB 6.6% COND DATA ERROR 19 PD NO
!BICARB 8.4% COND DATA ERROR 20 PD NO
!BICART COND DATA ERROR 263 PD NO
!BLD DATA ERROR 26 PD NO
!BLOOD FLOW DATA ERROR 27 PD NO
!BYPASS ALARM DATA ERROR 36 PD NO
!CONDUCTIVITY DATA ERROR 41 PD NO
!DATA ERROR 43 PD NO
!DIALYSAT FLOW DATA ERROR 45 PD NO
!DIALYSIS TIME DATA ERROR 239 PD NO
!DIASCAN FREQ. DATA ERROR 257 PD NO
! LONG POWER FAILURE 80 P YES
!MAX BLOOD FLOW DATA ERROR 312 PD NO
!PAUSE THERAPY DATA ERROR 313 PD NO
!S/N MAX PRESSURE DATA ERROR 209 PD NO
!S/N MIN PRESSURE DATA ERROR 208 PD NO
! SHORT POWER FAILURE 124 P YES
Rev. B
!TEMPERATURE DATA ERROR 135 PD NO
!TOT WEIGHT L DATA ERROR 240 PD NO
!UF DATA ERROR 143 PD NO
!VEN PRES LIMIT DATA ERROR 152 PD NO
!VENOUS PRES DATA ERROR 150 PD NO
!WLR MINIMUM DATA ERROR 164 PD NO
> GENERAL SAFE STATE < 64 P NO

See warning at end of section.
A CONNECTOR POSITION 2 B NO
ACE CAN IS EMPTY 1 A YES
ART PRESSURE LIMIT 11 A NO
ART PUMP POSITION 13 C YES
ART SENSOR ERROR 6 A NO
ARTERIAL CLAMP POSITION 7 A NO
ARTERIAL COVER IS OPEN 8 B NO
B CONNECTOR POSITION 18 B NO
BAD BLOOD LINE POSITION 219 A YES
BAD HYDRAULIC CONDITION 14 E NO
BICARB CAN IS EMPTY 24 A YES
BICART CONNECTOR POSITION 22 B NO
BICART IS EMPTY 21 A YES
BIOSLAVE MSG TRANSFER ERROR 297 C NO
BIOSLAVE CARD COMM. TIMEOUT 296 E NO
BLOOD CARD COMMUNICATION 295 E NO

TIMEOUT
BLOOD CARD MSG TRANFER ERROR 130 C NO
BLOOD MODULE<->MASTER DISK 259 A YES

MISMATCH
BLOOD PUMP JAMMED 12 C YES
BLOOD PUMP NOT IN START POSITION 29 E YES
BPM NOT CONNECTED 255 A YES
Rev. B
BPM: AID REQUEST 30 A YES
BPM: MEASUREMENT NOT MADE 32 A YES
BPM: SYSTEM FAILURE 31 A YES
BT1 LEVEL ERROR 33 E NO
BT1 MALFUNCTIONING 299 C NO
BT2 LEVEL ERROR 34 E NO
BT2 MALFUNCTIONING 268 C NO
BTP LEVEL ERROR 35 E NO
CENTR. ACID CONNECTOR POSITION 271 B NO
CENTR. BICARB CONNECTOR POSITION 272 B NO
CENTRYNET STATION OFFLINE 322 D NO
CENTRYNET: DUPLICATE STATION 321 D NO
CENTRYNET: INCOMPLETE DATA 323 E YES

COLLECTION
CENTRYNET: STATION ID ERROR 325 D NO
D1 OUT OF ORDER 300 C NO
D2 OUT OF ORDER 301 C NO
DIAL CONNECTOR POSITION 65 B NO
DIALYSER SAFETY PRESSURE 68 D NO
DIASCAN INITIAL CALIBRATION FAILED 244 B YES
DIASCAN: INCORRECT MEASUREMENT 246 C YES
DIASCAN: LIMIT LOW CLEARANCE 249 B YES
DIASCAN: MEAS. IMPOSSIBLE (ALARM) 270 B YES
DIASCAN: MEASUREM. IMPOSSIBLE (SET) 269 B YES
DIASTOLIC PRESSURE ALARM 46 A YES
DISINF CONNECTOR POSITION 47 B NO
E2PROM BIOSLAVE ERROR 50 E NO
E2PROM BLOOD ERROR 48 E NO
E2PROM HYDR ERROR 49 E NO
END DIA - TOTAL WL 53 B NO
Rev. B
END DIA - DIFF TIME REACHED 339 B NO
END DIA - TIMEOUT 51 B NO
END DIA - TOTAL BLOOD 52 B NO
END HEPARIN 55 A NO
END OF DIALYSATE PREPARATION 57 D NO
END OF HEPARIN TIME 58 B NO
END OF WASHBACK PROCEDURE 332 C YES
ERROR ON CALIBRATION TOOL 279 B NO
ERROR ON HEATER PROTECTION 59 A NO
ERROR ON TOTAL WEIGHT LOSS 60 B NO
FIXED DATA 63 C NO
FORECAST DIAL. DOSE NOT MATCH 354 E YES

PRESCRIP.
>> GENERAL SYSTEM FAILURE << System xxx / /
Blocking
HEART RATE ALARM 66 A YES
HEATING SYSTEM NOT STARTED 67 B NO
HEPARIN PUMP DIRECTION ERROR 69 E NO
HEPARIN SPEED ERROR 70 C NO
HEPARINISATION NOT STARTED 71 B YES
HIGH LEVEL IN DIS TANK 72 E NO
HIGH LEVEL IN UF VESSEL 73 E NO
HYD CARD MSG TRANSFER ERROR 131 C NO
HYDRAULIC CARD COMM. TIMEOUT 304 E YES
KT-KT/V TARGET ACHIEVED 355 YES
LOW LEVEL IN DIS TANK 82 E NO
LOW LEVEL IN UF VESSEL 83 E NO
LOW PRESSURE IN DEGASSER 84 E NO
LOW TEMPERATURE LIMIT REACHED 81 C NO
MAX PI PRESSURE 87 A NO
MAX PO PRESSURE 88 A NO
Rev. B
MAX TEMPERATURE LIMIT 90 B NO
MIN PI PRESSURE 94 A NO
MIN PO PRESSURE 95 A NO
NO POWER 353 A NO
NO WATER 100 A NO
OUTPUT OVERPRESSURE 206 A NO
P1 PUMP OUT OF ORDER 104 E NO
P2 PUMP OUT OF ORDER 106 B NO
PA AUTOCALIBRATION NOT PERFORMED 107 E NO
PA PUMP OUT OF ORDER 108 B NO
PB AUTOCALIBRATION NOT PERFORMED 109 E NO
PB PUMP OUT OF ORDER 110 B NO
PC PUMP FAILURE 111 E NO
PH MAXIMUM ALARM 112 E NO
PH MINIMUM ALARM 113 E NO
PI PRESSURE SENSOR ERROR 116 E NO
PO PRESSURE SENSOR ERROR 118 E NO
PRIME VOLUME COMPLETED 54 C YES
PUF AUTOCALIBRATION NOT PERFORMED 121 E NO
PUF PUMP OUT OF ORDER 122 B NO
S/N: VEN PRESSURE NOT CHANGING 351 A YES
S/N: VENOUS PRESSURE UNRELIABLE 352 B NO
START DIALYSIS DELAYED 129 B NO
SYSTOLIC PRESSURE ALARM 132 A YES
TIME OUT PROC 190 E NO
TIMEOUT ERROR ON PROCESS CLOSING 335 C NO
TIMEOUT ERROR ON PROCESS SELECTION 333 C NO
TIMEOUT ON PA AUTOCALIBRATION 139 E NO
TIMEOUT ON PB AUTOCALIBRATION 140 E NO
Rev. B
TIMEOUT ON PUF AUTOCALIBRATION 141 E NO
TOTAL HEPARIN INFUSED ERROR 338 B YES
TRANSMEMBRANE PRESSURE 142 C NO/YES

SEE NOTE 1
ULTRAFILTER : TMP TOO HIGH 237 B YES
ULTRAFILTER IS PACKED 138 B NO
ULTRAFILTER MAX PRESSURE 146 C NO
ULTRAFILTER PRESSURE SENSOR 147 C NO
ULTRAFILTER: LOWER SWITCH 61 B NO
ULTRAFILTER: UPPER SWITCH 38 B NO
VEN PRESSURE OUT OF RANGE 153 A NO
VEN SENSOR ERROR 159 A NO
VENOUS CLAMP POSITION 148 A NO
W! STILL IN MINIMUM UF 189 W YES
W! AD CONVERTER 165 W YES
W! AIR & FOAM DETECTOR 264 W YES
W! ANALOG HIVAR 166 W YES
W! ART PRESSURE SENSOR ERROR 317 W YES
W! BLD CALIBRATION PHASE 167 W YES
W! BLD FAST RECOVERY 168 W YES
W! BLD LED EXCESSIVE VALUE 169 W YES
W! BLD RECEIVER EXCESSIVE VALUE 170 W YES
W! BLOOD IN THE VENOUS LINE 308 W YES
W! BLOOD PUMP STOPPED BY ABD 318 W YES
W! BLOOD SENSED IN VENOUS LINE 359 W YES
W! COMMUNICATION CRC ERROR 327 W YES
W! DAC EXCURSION 172 W YES
W! DRIFT ON FLOWMETERS 343 W YES
W! E2PROM CRC 173 W YES
W! LOW ART FLOW FOR TOO LONG 204 W YES
Rev. B
W! MASS BALANCE NOT RELIABLE 309 W YES
W! PA AUTOCALIBRATION FAILED 176 W YES
W! PATIENT SENSOR SATURATION 273 W YES
W! PB AUTOCALIBRATION FAILED 177 W YES
W! PDR PRESSURE SENSOR ERROR 252 W YES
W! PI PRESSURE SENSOR 178 W YES
W! PO PRESSURE SENSOR 179 W YES
W! PUF AUTOCALIBRATION FAILED 180 W YES
W! PV PRESSURE SENSOR 181 W YES
W! RAM ERROR 175 W YES
W! SET VALUE OUT OF RANGE 250 W YES
W! STILL IN BYPASS 171 W YES
W! STILL IN PAUSE THERAPY 329 W YES
W! T1 TEST FAILED 183 W YES
W! T1TESTS DISABLED 203 W NO
W! TEMPERATURE SENSOR 184 W YES
W! U.F. CALCULATION NOT RELIABLE 220 W YES
W! UNKNOWN MESSAGE TYPE 185 W YES
W! UNRECOGNIZED SOFTWARE EXEC 182 W YES
W! VENOUS LINE NOT FITTED 205 W YES
W! VOLTAGES INCORRECT 187 W YES
W! WAIT FOR PRESSURE TEST EXECUTION 319 W YES
W! WAIT TO CONTINUE 188 W YES

SEE NOTE 3
WAIT FOR CONFIRMATION 283 E YES
WHF DOOR POSITIONING 326 B NO
Note 1
If the parameter TMP ALARM is set to NO in the Config menu, the alarm cannot be
overridden; if the parameter is set to YES, the alarm can be reset.
Rev. B
Note 2
OVERRIDE only has an effect if the measured venous pressure is less than +450 mmHg,
otherwise the safety activation is not removed.
Note 3
To RESET the alarm condition, press the OVERRIDE button then press the CONFIRM
button.
Rev. B
WARNING
In each alarm condition critical to the safety of the patient (Class P alarms), the Protection
Module checks that the actions relating to the specific safe state are performed correctly by
the machine.
If this test passes, the machine remains in the safe state until the cause of the alarm is
removed (as indicated in the Suggested Action).
Otherwise, i.e. if the safe state is not correctly configured, the Protection Module generates a
> GENERAL SAFE STATE < alarm and the following steps are taken:
The Dialysate Flow through the dialyser is stopped.
The Ultrafiltration Pump is stopped.
The Blood Pump is stopped.
The Venous Clamp is closed.
The machine is stopped and the patient isolated. The operator is warned by:
An alarm window with the message:

An Operator Message in the help window:
A Visual alarm, with a flashing red light of a 6-2 modulation (two flashes lasting 3/8 of a
second with an intervening pause of 1/8 of a second)
A high volume Audible alarm of 6-2 modulation.
A numerical code relative to the specific safe state that was not correctly configured (see
below).
The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped. This is a
latching alarm and in order to reset it, the machine must be switched OFF.
If a General Safe State occurs as a result of a T1 test failure, the following message is
displayed:
! T1 Test Failed
If a General Safe State is due to incorrect voltage, the following message is displayed:
! Voltages Incorrect
If a General Safe State is due to a Temperature elevated value alarm, the following message is
displayed:
! Temperature Excessive Value
WARNING
When the Blood Pump stops due to an alarm condition:
The venous pressure alarm window lower limit is automatically set to +10 mmHg and
the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg
(see Section 2 - Configuration Description, in this manual).
The arterial pressure alarm window lower limit is automatically set to the value set for
the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to
+150 mmHg.
These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the
Blood Pump restart.
Rev. B
WARNING
The machine is supplied with a special device called the Patient Sensor which has the task of
setting some class P alarms in an automatic OVERRIDE state when DIALYSIS has not yet
started, since the patients blood has not yet reached the venous line in the Patient Sensor.
Therefore, the relevant safety systems are locked until the presence of blood is detected to
allow a smooth start to the process.
This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the Touch
Screen. The Patient Sensor Icons are:
No blood has been detected
Blood has been detected but the operational test has failed. Not all the relevant safety
systems are activated.
Blood has been detected and all the relevant safety systems are activated.
For each Class P alarm, the possibility of an automatic OVERRIDE by the Patient Sensor and
the related effects are indicated, for each alarm in this section, by highlighting the symbol
in correspondence to the safe requests which are active only after either the Patient Sensor
has detected blood in the venous line, or after the DIALYSIS Action key has been pressed.
Note
In this section the icon is used to indicate the possibility to set the alarm to the OVERRIDE
state.
Rev. B
8.2 Numerical List of Alarms and relevant description

Below is a description, in numerical order, of all the alarms listed in the previous table.
ACE CAN IS EMPTY 1
Reason In DIALYSIS: The Acid/Acetate Pump (PA) has been driven at maximum speed for
for Alarm over 25 seconds due to the conductivity not reaching the set value.
In DESCALING: The Acid/Acetate Pump PA has been driven at maximum speed
for over 25 seconds and the wrong solution has been detected for DESCALING to
be performed.
Machine The Acid/Acetate Pump PA stops.

Actions
Possible Suggested
Cause Action
1. Acid/Acetate Concentrate container is 1. Supply appropriate concentrate to the
empty. relevant inlet connector following the
Acid/Acetate Concentrate Container
Change procedure (see Section 5.A
Special Procedures, in this manual).
2. Massive air leak from the Acid/Acetate 2. Check and if necessary change the
Concentrate Wand. Acid/Acetate Concentrate Wand. Press
OVERRIDE to continue.
3. If the VINEGAR DESCAL Action key has 3. Supply appropriate vinegar solution to the
been selected, the vinegar container is relevant inlet connector and press the
empty. OVERRIDE button to restart uptake of
vinegar into the machine.
4. If the DESCALING Action key has been 4. Supply appropriate concentrate/vinegar to
selected the Acid/Acetate container is the relevant inlet connector and press the
empty. OVERRIDE button to restart uptake of
concentrate to the machine.
5. The correct DESCALING procedure has not 5. Verify the correct solution, depending on
been selected for the descaling solution in the DESCALING procedure selected.
use.
6. Acid/Acetate Concentrate connector not 6. Verify the Concentrate connector is well
connected to the Concentrate Wand. fitted into the proper Wand. Press
Call for Service if the problem persists.
Rev. B
A CONNECTOR POSITION 2
Reason The Acid/Acetate Concentrate connector is not in the correct location for the
for Alarm phase of the machine.
Machine In ADR: the machine will stop and wait for the connector position to be
Actions corrected.
In DIALYSIS: during the preparation phase, the machine will not proceed:
during the treatment phase, the machine will automatically go into Bypass.
Possible Suggested
Cause Action
1. Acid/Acetate Concentrate Connector is in 1. Verify the right connector position in
the wrong position, or not fully inserted into relation to the machine phase.
its Rinse Port.
Rev. B
! AIR & FOAM DETECTOR 4
Attribute 1. Air Bubble

2. T0 Failure
Reason Air Bubble

for Alarm The presence of air is detected in the venous line at the Air Bubble Detector.
T0 Failure
The T0 Test, related to the ABD sensor, has failed.
Machine Stops the Blood Pump.

Actions
Closes the Venous Line Clamp.
Ultrafiltration Pump is reduced to its minimum value.
Possible Suggested
Cause Action
1. #4 with Attribute Air Bubble. 1. Procedure to clear the alarm.
Air or foam in the venous line (inside or a. Press the MUTE button to silence the
below the Air Bubble Detector). alarm.
b. Manually clamp the venous line below
the venous line clamp and any visible
air bubbles.
c. Clamp the venous dialyser line
between the dialyser and the venous
chamber. (If in SINGLE NEEDLE mode,
clamp the venous dialyser line
between the dialyser and the
expansion chamber.)
d. Open the white cap on the venous
access line of the Cartridge and attach
a sterile 10-20 ml syringe to the venous
access line of the Cartridge. Open the
venous access line clamp.
e. Aspirate until the venous pressure is
between 50 and -150 mmHg. Avoid a
negative pressure over -150 mmHg.
Close the venous access line clamp. (If
in SINGLE NEEDLE mode connect the
syringe to the access port on the post
dialyser expansion chamber) Remove
the syringe and replace the white cap
on the venous access line.
f. Press the OVERRIDE button to open
the Venous Line Clamp. The Venous
Line Clamp and the Air Bubble
Detector will deactivate for 30
Rev. B
seconds.(See Note 1 and Warning 1).

g. Slowly open the clamp on the venous
line. Air is drawn automatically into
the venous chamber. If air bubbles
remain, repeat the procedure from
step b.
h. Remove the clamp on the venous
dialyser line between the dialyser and
the venous chamber. (or in between
the dialyser and the post-dialyser
expansion chamber for SINGLE
NEEDLE.)
i. Press the RESUME button to restart the
blood pump at the previous value. (See
Warning 2)
j. If needed, adjust the blood level in the
Cartridge chambers
2. #4 with AttributeAir Bubble. 2. Proceed as follows:

Venous Line is scratched under the Air a. Move the venous line position a few
Bubble Detector. centimeters.
b. Follow the procedure to clear the alarm
described above.
3. #4 with Attribute Air Bubble. 3. Proceed as follows:

Air Bubble Detector door is open. a. Close the door of the Air Bubble
Detector.
b. Follow the procedure to clear this alarm
described above.
4. #4 with Attribute Air Bubble. 4. Proceed as follows:

Decreased Sensitivity of the Air Bubble a. Re-position the venous line.
Detector. b. Follow the procedure to clear this alarm
described above. If the problem persists
call for Service
5. #4 with Attribute T0 Failure. 5. Proceed as follows:

Failure in the electronic board. a. Follow the procedure to clear this alarm
described above. If the problem persists
call for Service

When the alarm #4 occurs, take note of the
values displayed for the parameters ABD
DIAGNOSTIC in the MACHINE view: this
information could be helpful for the service
technician.
Note 1
The Venous Line Clamp is not automatically opened if the venous pressure is not lower than
+10mmHg.
Rev. B
WARNING 1
Do not open the clamp in between the dialyser and the venous chamber (in DOUBLE
NEEDLE mode) or in between the dialyser and the post-dialyser expansion chamber (in
SINGLE NEEDLE mode) because the positive pressure at the blood side of the dialyser could
push air bubbles to the patient.
WARNING 2
RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in this
case the alarm #205 appears).
Note
Check for Air bubbles starting from PATIENT CONNECT, even if the Patient Sensor has not
detected blood.
Note
To prevent an !AIR IN BLOOD (#4) alarm, follow the guidelines below:
Follow the priming procedure carefully.
Ensure arterial line is connected securely and leak-free.
Carefully manage the extracorporeal accesses when administrating medication.
Ensure the blood levels in the Cartridge chambers are at the target level.
Rev. B
ART SENSOR ERROR 6
Reason The control system has detected a large spike or a large rapid change while
for Alarm monitoring the Arterial Pressure Sensor.
Machine The Blood Pump is stopped.

Actions The Ultrafiltration Pump speed is reduced to its minimum value.
Possible Suggested
Cause Action
1. Temporary problem. 1. Wait a few seconds for the alarm to be
cleared.
Rev. B
ARTERIAL CLAMP POSITION 7
Reason The optical switch on the Arterial Line Clamp indicates that the clamp is open
for Alarm when it should be closed or it is closed when it should be open. This alarm only
applies to single needle machines.
Machine The Blood Pump stops.

Possible Suggested
Cause Action
1. Arterial Line Clamp obstructed. 1. Verify the Arterial Line Clamp is free from
obstruction. Only the arterial line should be
inserted into the clamp.
2. Arterial Line Clamp dirty. 2. Carefully clean the Arterial Line Clamp with
a cloth dipped in a disinfectant solution.
Rev. B
ARTERIAL COVER IS OPEN 8
Reason The Blood Pump Cover is open.

for Alarm

Possible Suggested
Cause Action
1. Blood Pump Cover is open. 1. Close the Blood Pump Cover. Be sure the
Blood Pump Cover is securely latched.
2. The magnet is dirty. 2. Carefully clean the magnet placed behind
the Blood Pump Door with a cloth dipped in
a disinfectant solution.
Note
The check for the front cover of the Blood Pump is enabled at the beginning of PRIME.
Rev. B
! ARTERIAL PUMP 10
Attribute 1. Minimum
2. Maximum
3. Undefin
4. Line Pres
Reason Minimum
for Alarm The actual flow of the Blood Pump is less than the set value or the minimum
permitted value.
Maximum
The actual flow of the Blood Pump is higher than the set value or the maximum
permitted value.
Undefin
There is an error in the reading from the encoder on the Blood Pump or the rotor
position sensors.
Line Pres
The venous line is not inserted inside the Air Bubble Detector housing.

Actions
Possible Suggested
Cause Action
1. The Blood Pump speed is different from the 1. Press OVERRIDE to restart the Blood Pump.
set value.
2. The venous line is not inserted inside the Air 2. Check the venous line position.
Bubble Detector housing.
Rev. B
ART PRESSURE LIMIT 11
Reason The arterial pressure is beyond the upper or lower limit of the sensor.
for Alarm

Possible Suggested
Cause Action
1. Restriction of blood flow from the arterial 1. Check for restriction of blood flow in the
access or in the arterial line. arterial line, i.e. kinks, clamps, clotted arterial
needle, poor flow from the patients arterial
access.
The alarm clears when the arterial pressure
is in the proper range.
2. Arterial pressure decreased somewhat 2. Attention should be given to re-evaluating
during a treatment due to needle size, blood flow rate, anticoagulant
hemoconcentration and/or inadequate dosage.
heparinization of the patient and a resulting
pressure drop increase for a given needle at
a fixed blood flow rate.
Rev. B
BLOOD PUMP JAMMED 12
Reason The Blood Pump Rotor is jammed and will not turn or the blood slave board does
for Alarm not see the signal from the Blood Pump board.

Possible Suggested
Cause Action
1. Cartridge Blood Set Pump segment is 1. Verify the correct placement of the
jamming the Rotor of the Blood Pump. Cartridge. Press OVERRIDE to restart the
Blood Pump.
2. The Blood Pump Rotor is jammed. 2. Verify the Blood Pump Rotor is not
obstructed. Press OVERRIDE to restart the
Blood Pump.
Rev. B
ART PUMP POSITION 13
Reason The Blood Pump Rotor could not be positioned by the Blood Board while in IDLE,
for Alarm or the machine is not sensing a Cartridge Blood Set.
Machine None.
Actions
Possible Suggested
Cause Action
1. The venous and arterial lines are not in their 1. Verify the Cartridge position. The arterial
proper position. line should be placed in the Arterial Line
Clamp (if present), the venous line into the
Air Bubble Detector and the Venous Line
Clamp. Press OVERRIDE to clear the alarm.
2. The Blood Pump Rotor is jammed. 2. Verify the Blood Pump Rotor is not
obstructed. Manually position the Blood
Pump Rotor to a horizontal position. Press
OVERRIDE to clear the alarm.
Rev. B
BAD HYDRAULIC CONDITION 14
Reason Problem or configuration issue with the hydraulic portion of the machine. See the
for Alarm operator message box for more details.
Machine The machine goes into a RESTART condition.

Actions
Possible Suggested
Cause Action
1. No water. 1. Verify adequate water supply to machine.
Press RESTART to continue.
2. Drain Line is kinked or occluded. 2. Verify that the Drain Line is not kinked or
occluded. Press RESTART to continue.
3. Dialysate Connectors in the wrong position. 3. Verify the Dialysate Connectors are well
connected in the correct position for the
current operation of the machine. Press
RESTART to continue.
4. Dialysate Lines kinked. 4. Verify that the Dialysate Lines are not
kinked. Press RESTART to continue.
WARNING
When the patient is connected, if the first selection of the RESTART key doesnt clear the
alarm, re-check carefully all the possible causes of the alarm then press again the RESTART
key. Never press the RESTART key more than 2 or 3 times if the problem that is causing the
RESTART condition has not been identified.
Rev. B
B CONNECTOR POSITION 18
Reason The Bicarbonate Concentrate Connector is not in the correct position for the phase
for Alarm of the machine.
Machine In ADR: the machine will stop and wait for the connector position to be
Actions corrected.
In DIALYSIS: during the preparation phase, the machine will not proceed;
during the treatment phase, the machine will automatically go into bypass.
Possible Suggested
Cause Action
1. Bicarbonate Concentrate Connector is in 1. Verify the right connector position in
the wrong position or not fully inserted into relation with the machine phase.
its rinse port.
Rev. B
! BICARB 6.6% COND DATA ERROR 19
Reason A data difference was detected inside the double image of the Protection System
for Alarm in the Main Board, for the BIC 6.6% COND parameter.
Machine None
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In Set mode, restore the parameter to the
double image of the Protective System in correct value. If the alarm persists, restart
the Main Board, for the BIC 6.6% COND the machine.
parameter.
Rev. B
! BICARB 8.4% COND DATA ERROR 20
for Alarm in the Main Board, for the BIC 8.4% COND parameter.
Machine None
Actions
Possible Suggested
Cause Action
double image of the Protection System in correct value. If the alarm persists, restart
the Main Board, for the BIC 8.4% COND the machine.
parameter.
Rev. B
BICART IS EMPTY 21
Reason The Bicarbonate Pump is being driven to maximum speed for greater than 25
for Alarm seconds, due to the conductivity not reaching the set value.
Machine The Bicarbonate Pump stops.

Actions
Possible Suggested
Cause Action
1. BiCart cartridge is almost empty. 1. Replace the BiCart according to the
directions in the operator manual. Press
OVERRIDE to restart uptake of bicarbonate.
2. BiCart cartridge in wrong position. 2. Verify the correct position of the BiCart in its
holder. Press OVERRIDE to restart uptake of
bicarbonate.
Rev. B
BICART CONNECTOR POSITION 22
Reason The BiCart Holder Arms are not in the required position for the current operating
for Alarm phase.
Machine In ADR: The machine stops and waits for both Holder Arms to be moved to
Actions the correct position.
In DIALYSIS: During the dialysate preparation phase, the machine will not
proceed. During the treatment phase, the machine will go into bypass
when one of the two Holder Arms is in the incorrect position.
Possible Suggested
Cause Action
1. BiCart Holder Arms are in the wrong 1. Verify the correct position of the BiCart
position, or not closed securely. Holder Arms in relation to the machine
phase.
Rev. B
! BIC CONDUCTIVITY 23
2. Maximum
Reason Minimum
for Alarm Value of Bicarbonate Conductivity is lower than the value set by the operator or
the permitted minimum.
Maximum
Value of Bicarbonate Conductivity is higher than the value set by the operator or
the permitted maximum.
Machine During a dialysis treatment, the machine will go into BYPASS.

Actions
Possible Suggested
Cause Action
1. Bicarbonate Concentrate container or 1. Verify adequate levels of Concentrates. If
BiCart are almost empty. BiCart, replace as directed in the Operators
Manual.
2. Bicarbonate Concentrate Connector not 2. Verify the connector is well fitted to the
well fitted to the Concentrate Wand. proper wand.
3. Massive air leak from the Bicarbonate 3. Change Bicarbonate Concentrate Wand.
Concentrate Wand.
4. BiCart not well positioned in its holder. 4. Ensure the BiCart is securely placed in its
holder.
Rev. B
BICARB CAN IS EMPTY 24
Reason The Bicarbonate Pump has been driven at the maximum speed for greater than 30
for Alarm seconds due to a loss in Bicarbonate Conductivity.
Machine The Bicarbonate Pump is shut off.

Actions
Possible Suggested
Cause Action
1. Bicarbonate Concentrate Container is 1. Supply appropriate concentrate to the
empty. relevant inlet connector and press
OVERRIDE to restart uptake of bicarbonate.
2. Bicarbonate Concentrate Connector not 2. Verify the connector is well fitted to the
well fitted to the Concentrate Wand. proper wand. Press OVERRIDE to continue.
3. Massive air leak from the Bicarbonate 3. Change Bicarbonate Concentrate Wand.
Concentrate Wand. Press OVERRIDE to continue.
Rev. B
! BLD DATA ERROR 26
for Alarm in the Main Board, for the BLD SENS parameter.
Machine None
Actions
Possible Suggested
Cause Action
the Main Board, for the BLD SENS the machine.
parameter.
Rev. B
! BLOOD FLOW DATA ERROR 27
for Alarm in the Main Board, for the BLOOD FLOW parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. Re-enter a different blood flow rate, then
double image of the Protection System in restore the parameter to the correct value. If
the Main Board, for the BLOOD FLOW the alarm persists, restart the machine.
parameter.
Rev. B
! BLOOD LEAKAGE 28
Reason The machine has detected a blood leak into the hydraulic circuit either at a level of
for Alarm 0.30 ml/min or at a rate of 0.45 ml/min (HIGH or LOW sensitivity set value).

Actions
Possible Suggested
Cause Action
1. Dialyser is leaking blood into the hydraulic 1. Test the dialysate for the presence of blood.
circuit. If the results are positive, replace the
dialyser and the Cartridge Blood Set. Follow
the correct procedure to replace the
extracorporeal circuit. Before starting a new
dialysis treatment perform an ADR
disinfection.
2. The Blood Leak Sensor is dirty. 2. Test the dialysate for the presence of blood.
If the results are negative consider reducing
the sensitivity of the sensor to its low value
to complete the treatment (BLD SENS
parameter). Press OVERRIDE.
3. The Blood Leak Sensor is dirty and the 3. If the dialysate tested negative for the
sensitivity is set to LOW. presence of blood, the Blood Leak Sensor
parameter is set to LOW and the alarm
persists, stop the treatment. As soon as
possible perform a chemical disinfection to
clean the Blood Leak Sensor.
4. Massive air leak from the Dialysate 4. Verify the Dialysate Connectors do not leak.
Connectors. Put the machine in BYPASS and verify that
the Dialysate Connectors are well fitted to
the dialyser. Remove from BYPASS. Press
OVERRIDE.
WARNING
If the !Blood Leakage # 28 alarm occurs and the identified cause is Dialyser is leaking
blood into the hydraulic circuit, perform an ADR disinfection before starting a new dialysis
treatment. Presence of blood in dialysate might result in a possible contamination of the
hydraulic circuit with bacteria or viruses. If the ADR disinfection is not correctly performed
before starting a new dialysis treatment, blood into the hydraulic circuit may cause cross-
contamination problems resulting in patient injury or death.
Rev. B
BLOOD PUMP NOT IN START POSITION 29
Reason A problem was encountered during the initial reset phase that would not allow the
for Alarm Blood Pump to position itself correctly.
Machine None.
Actions
Possible Suggested
Cause Action
1. The Blood Pump Cover is open or not 1. Verify the Blood Pump Cover is closed,
completely closed. press OVERRIDE to clear the alarm or
restart the machine.
Rev. B
BPM: AID REQUEST 30
Reason Incorrect calibration of the BPM device.

for Alarm
Machine Blood pressure monitoring is stopped and the measurement is not available.
Actions
Possible Suggested
Cause Action
1. Temporary blockage of the device 1. Press OVERRIDE to clear the alarm. Do not
perform any other measurements. In
DIALYSIS, wait for the end of the treatment,
turn OFF the machine, wait a few seconds
and turn it ON again. From the IDLE view
try a blood pressure measurement.
Rev. B
BPM: SYSTEM FAILURE 31
Reason The BPM is not taking measurements because of high or low pressure detected in
for Alarm the cuff.
Actions
Possible Suggested
Cause Action
1. Tubing is kinked or disconnected. 1. Verify that the external tubing is connected
and there are no leaks or kinks. Press
OVERRIDE and retry the measurement.
2. The patient moved his arm too many times 2. Press OVERRIDE and retry the
during the measurement. The BPM was measurement.
unable to measure the blood pressure.
3. The external Blood Pressure Cuff tubing or 3. Replace the cuff tubing and the cuff with a
the cuff itself is leaking. new one.
4. There is a communication problem between 4. Repeat the measurement.
the cuff and the machine.
Call for Service if the problem persists
Rev. B
BPM: MEASUREMENT NOT MADE 32
Reason The blood pressure monitor was unable to take a blood pressure measurement.
for Alarm
Actions
Possible Suggested
Cause Action
1. The patient moved during the measurement. 1. Press OVERRIDE and retry the
The BPM was unable to detect the systolic measurement.
or diastolic pressure.
2. Incorrect position of the cuff. 2. Check the position of the cuff. Press
OVERRIDE and retry the measurement.
3. The external blood pressure cuff tubing or 3. Replace the cuff tubing and the cuff with a
the cuff itself is leaking. new one. Press OVERRIDE to clear the
alarm.
4. Tubing is kinked or disconnected. 4. Verify that all of the external tubing is
connected and there are no leaks or kinks.
Press OVERRIDE and retry the
measurement.
Call for Service if the problem persists
Rev. B
BT1 LEVEL ERROR 33
Reason LD1 Level Sensor failed its test during dialysis preparation or an ADR process. The
for Alarm level sensor may have detected air, failed or needs to be cleaned.
Machine In ADR: The Time Out Proc (#190) alarm is generated which causes the
Actions machine to stop the procedure and to go to a RESTART condition.
In DIALYSIS: None.
Possible Suggested
Cause Action
1. Massive air leak from an empty concentrate 1. Check for empty Acid/Acetate, BiCart or
container. Bicarbonate Container. The alarm clears
before patient connection.
2. Dirty LD1 Level Detector. 2. Perform a RINSE or a Chemical Disinfection
to clean the sensor of deposits.
3. Concentrate Line is not in the proper 3. Verify proper placement of the Concentrate
position for the current phase of the Line for the current phase of the machine.
machine.
4. BiCart Holder Arms are not in the fully 4. Place the BiCart Holder Arms in the closed
closed position. position.
Rev. B
BT2 LEVEL ERROR 34
Reason LD2 Level Sensor failed its test during dialysis preparation or a cleaning process.
for Alarm The Level Sensor may have detected air, failed or needs to be cleaned.
Machine In ADR: None.

Actions In DIALYSIS: None.
Possible Suggested
Cause Action
1. Massive air leak from an empty Concentrate 1. Check for empty Acid/Acetate, BiCart or
Container. Bicarbonate Container. The alarm stays until
the end of the treatment.
2. Dirty LD2 Level Detector. 2. Perform a RINSE or a Chemical Disinfection
to clean the sensor of deposits.
3. Concentrate Line is not in the proper 3. Verify that the Concentrate Lines are in the
position for the current phase of the proper position for the current phase of the
machine. machine.
4. BiCart Holder Arms are not in the fully 4. Move the BiCart Holder Arms to the closed
closed position. position to clear this alarm and to allow
cleaning of the complete circuit.
Rev. B
BTP LEVEL ERROR 35
Reason LP Level Sensor failed its test during dialysis preparation or an ADR process. The
for Alarm level sensor may have detected air, failed or needs to be cleaned.
Machine In ADR: the Time Out Proc (#190) alarm is generated which causes the
Actions machine to stop the procedure and to go to a RESTART condition.
In DIALYSIS: None.
Possible Suggested
Cause Action
1. Dirty LP Level Detector. 1. Perform a RINSING or a Chemical
Disinfection to clean the sensor of deposits.
Rev. B
! BYPASS ALARM DATA ERROR 36
for Alarm in the Main Board, for the BYPASS ALARM parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. Return to IDLE view, in Configuration menu
double image of the Protective System in restore the parameter to the correct value. If
the Main Board, for the BYPASS ALARM the alarm persists, restart the machine.
parameter.
Rev. B
ULTRAFILTER: UPPER SWITCH 38
Reason The Ultrafilter Upper Microswitch (SWFS) located on the rear of the machine is
for Alarm indicating a problem condition.
Machine In ADR: The machine goes into the RESTART condition.

Actions In Dialysate preparation: The machine will not continue until the
microprocessor sees the correct signal from the switch.
In DIALYSIS: The machine bypasses the dialyser.
Possible Suggested
Cause Action
1. In Dialysate preparation: incorrect position 1. Carry out the following operations:
of the Ultrafilter or Bypass fitting. If an ultrafilter is installed, verify that it is
correctly mounted covering both micro
switches.
If an ultrafilter is not installed, verify that
the clean dialysate bypass fitting is
installed correctly on the lower bracket.
2. Incorrect ULTRAFIL. USE parameter. 2. Verify that the correct ULTRAFIL. USE
parameter value is in memory.
Rev. B
! PROTECTIVE MSG TRANSFER ERROR 39
Reason A communication problem has been detected in the transmission of data between
for Alarm the Master Module and the Protection Module.
Machine None.
Actions
Possible Suggested
Cause Action
1. A communication problem has been 1. Wait for a few seconds for the alarm to
detected in the transmission of data clear.
between the Master Module and the If it does not clear, enter the last safety
Protection Module. related parameter which failed to restore
the communication.
If it does not clear, turn the machine off,
then back on and continue with the
procedure being performed.
Rev. B
! CONCENTRATE CANS 40
Attribute 1. LOW PH
2. HIGH PH
3. A Pump
4. B Pump
5. A+B PUMPS
Reason LOW PH
for Alarm The measured pH is lower than the permitted value.
HIGH PH
The measured pH is higher than the permitted value.
A PUMP;B PUMP; A+B PUMPS
A discrepancy is indicated between the conductivity of the dialysate both for the
dialysate flow and the rotation speed of the associated Pump/Pumps. The actual
Pump(s) speed does not match with the actual concentrate(s) used.
Machine Bypasses the dialyser.

Actions
Note
Autocalibration of the Pumps is possible from the beginning of dialysate preparation to phase 8,
and from phase 9 on, each time the alarm occurs with the A Pump, B Pump or A+B Pumps
attribute.
Note
PB autocalibration is only available with liquid bicarbonate.
Possible Suggested
Cause Action
1. Machine has run out of concentrates. 1. Replace the empty container, then wait a
few seconds for the machine to stabilize.
2. If the attribute is A Pump or B Pump or A+B 2. Verify that the correct concentrate type is
Pumps, concentrate type was/were changed connected to the machine. Verify that the
and the PA/PB/PA+PB conductivity is stable, then perform a
autocalibration/autocalibrations was/were PA/PB/PA+PB autocalibration/
not performed. autocalibrations.
3. Air leak from a Concentrate 3. Verify there are no air leaks from the
Connector/BiCart. Concentrate Connectors/BiCart.
4. The Concentrate Connector has 4. Rinse accumulated debris from the
accumulated debris or salt crystals. Connector.
5. The Concentrate Line is not properly 5. Verify that the Concentrate Lines are
connected to the Concentrate Container securely connected and that no air bubbles
are being draw into the lines.
Rev. B
6. The solution in the Concentrate Container is 6. Stop the dialysis preparation and replace the
not a solution correct for haemodialysis Cartridge Blood Set and the dialyser with a
treatments (see Section 9 Specification, in new Cartridge Blood Set and a new dialyser.
this manual). Run a complete RINSE procedure. Replace
the solution with the correct solution and
then restart the dialysis preparation.
7. The solution in the Concentrate Container is 7. Verify that the solution is the correct
not correct or is dilute. concentrate and/or replace the solution
with the correct solution.
8. The Acid Concentrate Connector is not 8. Verify that the Acid Connector is securely
securely connected to its Rinse Port. (If connected to its Rinse Port.
using concentrate from a central delivery
system)
9. Ensure that the correct type of dialysate has 9. In SETUP, select the correct concentrate
been selected on the Dialysate Select view. type.
Rev. B
! CONDUCTIVITY DATA ERROR 41
for Alarm in the Main Board, for the CONDUCTIVITY parameter.
Machine None.
Actions
Possible Suggested
Cause Action
the Main Board, for the CONDUCTIVITY the machine.
parameter.
Rev. B
! DATA ERROR 43
Reason A difference was detected when data was stored in the Protection Module.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. A difference was detected when data was 1. In Config the operator must restore the
stored in the Protection Module. parameters not related to the safety of the
patient. If not cleared, turn the machine
OFF, then back ON and continue with the
procedure being performed.
Rev. B
! DIALYSATE FLOW 44
2. Maximum
3. Undefin
Reason The actual flow of the dialysate is different from the set value.
for Alarm MINIMUM
The actual flow of the dialysate is lower than the set flow or minimum permitted
flow.
MAXIMUM
The actual flow of the dialysate is higher than the set flow or maximum permitted
flow.
UNDEFIN
The machine is unable to measure dialysate flow.
Machine Machine bypasses the dialyser.

Actions
Possible Suggested
Cause Action
1. Unstable dialysate flow has been detected 1. Press OVERRIDE to continue with the
by the machine. treatment.
2. There are deposits or debris inside the 2. Perform a Descaling or a Chemical
flowmeters of the machine. Disinfection.
Rev. B
! DIALYSAT FLOW DATA ERROR 45
for Alarm in the Main Board, for the DIALYSATE FL. parameter.
Machine None.
Actions
Possible Suggested
Cause Action
double image of the Protection System in correct value.
the Main Board, for the DIALYSATE FL.
parameter.
Rev. B
DIASTOLIC PRESSURE ALARM 46
Reason The diastolic pressure measurement made by the BPM device is outside the limits
for Alarm set by the operator in configuration.
Machine None.
Actions
Possible Suggested
Cause Action
1. The diastolic pressure is out of the range set 1. Press OVERRIDE to reset the alarm. Retry
in configuration. the measurement and compare it with a
manual blood pressure cuff. Refer to your
internal policy and consider changing the
Maximum or Minimum limit of this alarm in
SET mode for this patient.
2. The cuff is improperly applied. 2. Check cuff application, repeat
measurement.
3. The patient moved during the reading. 3. Retry measurement.
4. The blood pressure cuff is not working 4. Take a comparison blood pressure
properly. measurement with a correctly calibrated
manual sphygmomanometer.
Rev. B
DISINF CONNECTOR POSITION 47
Reason The Disinfectant Connector is not in the proper position for the phase of the
for Alarm machine.
Machine In ADR: the machine will stop and wait until the connector is put in the
Actions proper position.
In DIALYSIS: none
Possible Suggested
Cause Action
1. The Disinfectant or Concentrate Connector 1. Verify the connector is in the proper
is in the wrong position, or not fully inserted position in relation to the machine phase.
into its Rinse Port.
Rev. B
E2PROM BLOOD ERROR 48
Reason Problem detected with the calibration coefficients in the Blood board EEPROM.
for Alarm Default coefficients will be used to run the machine.
Machine None.
Actions
Possible Suggested
Cause Action
1. Error with calibration parameters in the 1. Discontinue the treatment.
Blood board EEPROM.
Rev. B
E2PROM HYDR ERROR 49
Reason Problem detected with the calibration coefficients in the Hydraulic board EEPROM.
Machine None.
Actions
Possible Suggested
Cause Action
Hydraulic board EEPROM.
Rev. B
E2PROM BIOSLAVE ERROR 50
Reason Problem detected with the calibration coefficients in the Bioslave board EEPROM.
Machine None.
Actions
Possible Suggested
Cause Action
Bioslave board EEPROM.
Rev. B
END DIA - TIMEOUT 51
Reason This message signals the operator that the DIALYSIS TIME is complete. This is only
for Alarm used if TIME has been selected as the condition to end the dialysis treatment (END
DIALYSIS parameter).
Machine None.
Actions
Note
This alarm doesnt occur when Profiling is active, even if the alarm condition has been reached.
Note
If the DIALYSIS TIME is increased following the occurrence of this alarm, the DIFFUSION TIME
parameter will not be updated.
Possible Suggested
Cause Action
1. DIALYSIS TIME is complete. 1. Disconnect patient.
2. Additional DIALYSIS TIME may be needed. 2. Increase the set DIALYSIS TIME to lengthen
the treatment.
Rev. B
END DIA - TOTAL BLOOD 52
Reason This message signals the operator that the amount of the blood selected to be
for Alarm dialysed is complete. This is only used if T BL has been selected as the condition
to end the dialysis treatment (END DIALYSIS parameter).
Machine None.
Actions
Note
Possible Suggested
Cause Action
1. The total blood has been processed. 1. Disconnect patient.
2. Additional dialysis is needed even though 2. Increase the set blood volume to lengthen
the blood volume has been processed. the treatment.
Rev. B
END DIA - TOTAL WL 53
Reason This message signals the operator that the patients weight removal has been
for Alarm completed. This is only used if TWL has been selected as the condition to end the
dialysis treatment (END DIALYSIS parameter).
Machine The hourly weight loss of the patient is automatically set to the minimum
Actions value.
Note
Possible Suggested
Cause Action
1. The TOT WEIGHT L programmed is 1. Disconnect patient.
complete.
2. Additional dialysis is needed even though 2. Increase the set TOT WEIGHT L to
the TOT WEIGHT L programmed has been lengthen the treatment, then deselect the
removed. WLR MINIMUM key.
Rev. B
PRIME VOLUME COMPLETED 54
Reason The Blood Pump has finished priming. The quantity of physiological solution, which
for Alarm has passed through the dialyser, is equal to that selected by the operator during the
PRIME process.
Machine Blood Pump stops.

Actions
Possible Suggested
Cause Action
1. Priming is complete. 1. Press OVERRIDE to clear the alarm and
proceed with set up.
2. Additional priming is required. 2. Repress PRIME and select a priming
procedure.
Rev. B
END HEPARIN 55
Reason The heparin syringe is at the end of its travel.

for Alarm Heparin Line Clamp is not open.
Machine Stops the Heparin Pump.

Actions
Possible Suggested
Cause Action
1. Heparin syringe is empty. 1. Turn off the heparin program, refill the
syringe, place it back on the pump. Verify
the Heparin Line Clamp is open, perform a
manual bolus if desired. Restart the
program.
2. Blocked heparin line. 2. Verify the Heparin Line Clamp is closed on
the heparin line of the 4 position line clamp.
Turn off the heparin program and use the
RIGHT arrow button on the Heparin Control
Panel to decrease pressure then use the
LEFT arrow button to ensure the heparin
syringe plunger clamp is in contact with the
syringe plunger. Open the Heparin Line
Clamp, perform a manual bolus if desired.
Restart the program and verify the machine
is delivering the correct heparin quantity.
3. Defective syringe. 3. Turn off the heparin program, refill a new
syringe, place it back on the pump. Verify
the Heparin Line Clamp is open, perform a
manual bolus if desired. Restart the
program.
4. Incorrect position of the syringe. 4. Ensure that the syringe is properly placed in
the syringe holder.
Rev. B
END OF DIALYSATE PREPARATION 57
Reason The dialysate preparation process is complete.

for Alarm
Machine The machine waits for the dialyser to be primed.

Actions
Possible Suggested
Cause Action
1. Dialysate preparation is complete. 1. Machine is ready to prime a dialyser. Select
the appropriate keys to prime the dialyser.
Note
In CONFIGURATION of the machine it is possible to turn this ALARM OFF (END PRE ALARM
parameter). If set to OFF, this alarm will not occur.
Rev. B
END OF HEPARIN TIME 58
Reason The programmed PRE STOP TIME has been reached.

for Alarm

Actions
Possible Suggested
Cause Action
1. Heparin infusion is complete. 1. Select the HEPARIN view. Deactivate the
heparin program to clear the alarm.
2. The patient needs more heparin. 2. Set a new value for the PRE STOP TIME,
lower than the previous one.
Note
In CONFIGURATION of the machine it is possible to turn this ALARM off. If set to OFF, this alarm
will not occur.
Rev. B
ERROR ON HEATER PROTECTION 59
Reason The alarm appears if the Heater malfunctions or if there is a problem in the
for Alarm protection circuit of the heater.
Machine The Heater is turned off.

Actions
Possible Suggested
Cause Action
1. Error in the heating system. 1. Turn the machine OFF, perform a Fast
Recovery of the Dialysis process (see
Section 5.A - Special Procedures, in this
manual) if in treatment.
Rev. B
ERROR ON TOTAL WEIGHT LOSS 60
Reason There is greater than a 100 gram difference between the actual total fluid removed
for Alarm and the programmed TOT WEIGHT L.
Machine None.
Actions
Possible Suggested
Cause Action
1. The UF Rate has not been confirmed after 1. Confirm the UF Rate by selecting SET from
the TOT WEIGHT L has been set. the HOME view, selecting UF Rate and
pressing CONFIRM (the machine calculates
the UF Rate for the TIME and TOT WEIGHT
L values).
2. There is a difference between the actual 2. To match the current dialysis treatment with
Total Fluid Removed and the programmed the Target Loss, enter SET mode and
TOT WEIGHT L. The operator changed the CONFIRM the UF Rate calculated.
TOT WEIGHT L, but forgot to CONFIRM
the new UF Rate.
3. Interruption in the operation of the 3. To match the current DIALYSIS treatment
DIALYSIS mode. Alarms or operations set with the TOT WEIGHT L, enter the SET
the Minimum UF Rate for too long. mode and CONFIRM the new UF Rate
calculated. If UF Profiling is activated, a
COMPENSATION Action key will appear in
PROFILE view. Select the COMPENSATION
Action key for a new profile rate to be
established so that the TOT WEIGHT L may
be achieved.
4. Operator placed the machine in Minimum 4. To match the current DIALYSIS treatment
UF for too long or the machine remained in with the TOT WEIGHT L, enter the SET
PATIENT CONNECT, after blood detection, mode and CONFIRM the new UF rate
for too long. calculated. If UF Profiling is activated, a
COMPENSATION Action key will appear in
PROFILE view. Select the COMPENSATION
Action key for a new profile rate to be
established so that the TOT WEIGHT L may
be achieved.
Rev. B
ULTRAFILTER: LOWER SWITCH 61
Reason The ultrafilter lower microswitch (SWBY) is indicating a problem condition.

for Alarm
Machine In ADR: The machine goes into the RESTART condition.

Actions In Dialysate preparation: The machine will not continue until the
microprocessor sees the correct signal from the switch.
In DIALYSIS: The machine bypasses the dialyser.
Possible Suggested
Cause Action
1. In Dialysate preparation: incorrect position 1. If an Ultrafilter is installed, verify that it is
of the Ultrafilter or bypass fitting located correctly mounted covering both
behind the machine. microswitches. If an Ultrafilter is not
installed, verify that the clean dialysate
bypass fitting is installed correctly on the
lower bracket.
2. Incorrect ULTRAFIL. USE parameter. 2. Verify that the correct ULTRAFIL. USE
parameter value is entered in Config.
Rev. B
! FINAL CONDUCTIVITY 62
2. Maximum
Reason The conductivity of the dialysate is above or below the allowed limit.
for Alarm
Machine In DIALYSIS: the machine will bypass the dialyser.

Actions
Possible Suggested
Cause Action
1. Acid/Acetate or Bicarbonate Concentrate 1. Supply appropriate concentrate to the
Container is empty. relevant inlet connector. Wait for stability
of the dialysate flow.
2. Acid/Acetate or Bicarbonate Concentrate 2. Verify the Connector(s) are properly
Connector(s) are not properly positioned to positioned to the proper wand(s). Wait for
the concentrate Wand(s). stability of the dialysate flow.
3. Massive air leak from the Concentrate 3. Change Concentrate Wand. Wait for
Wand. stability of the dialysate flow.
4. The Acid/Acetate or Bicarbonate 4. Rinse accumulated debris from the
Connector(s) has accumulated debris or Connector(s).
salt crystals.
5. Inappropriate solution in the Acid/Acetate 5. Verify that the solution is the correct
Concentrate Container. concentrate and dilution.
6. When using Central Delivery Acid, the 6. Verify that the Acid/Acetate or Bicarbonate
Acid/Acetate or Bicarbonate Connector is Connector is properly positioned in its
not securely connected to its Rinse Port. Rinse Port.
Rev. B
FIXED DATA 63
Reason This alarm will display if the operator selects Disinfection (HEAT or CHEMICAL) or
for Alarm RINSE modes and does not start the mode.
Machine The machine will not proceed.

Actions
Possible Suggested
Cause Action
1. The operator did not start the process to be 1. Turn OFF the machine and turn it ON.
performed. Repeat the process to perform.
Rev. B
> GENERAL SAFE STATE < 64
Reason THIS IS A SPECIAL ALARM. A FULL DESCRIPTION APPEARS IN THE WARNING

for Alarm AT THE END OF THE PRECEDING SUB-SECTION. SEE THE POSSIBLE CAUSE FOR
DIFFERENT INDICATIONS.
Machine 1. Bypasses the dialyser.

Actions 2. Stops the Ultrafiltration Pump.
3. Stops the Blood Pump.
4. Closes the Venous Line Clamp.
5. Audible alarm cannot be muted or overridden.
Possible Suggested
Cause Action
1. A safety condition has not been satisfied 1. Turn off the machine. See the Fast
when an alarm occurred. Recovery of the Dialysis process in the
Section 5.A - Special Procedures. If the
alarm reoccurs, disconnect the patient and
turn off the machine.
2. A T1 Test failed during preparation. 2. Verify that the dialysate Connectors are
well fitted to the machine. Verify the
Cartridge is not blocking the Blood Pump
Rotor. Turn the machine OFF, then try
again to start up.
Note
If this alarm occurs during a treatment, the operator restarts the machine and the Patient Sensor
detects blood, the machine will allow the operator to do a Fast Recovery of the Dialysis process
(See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures).
This enables the user to bypass many of the T1 tests so that the machine can continue the
treatment from Patient Connect.
Rev. B
DIAL CONNECTOR POSITION 65
Reason The flow sensor (LFD) has detected an incorrect flow through the Dialysate
for Alarm Connectors for the current phase.
Machine The machine will go to a RESTART condition.

Actions
Possible Suggested
Cause Action
1. Dialysate Connectors in the wrong 1. Correctly connect the dialyser Connectors
position. to the Bypass Connectors or to the dialyser
depending upon the phase of the machine
at that time, then press RESTART.
2. Dialysate Connectors not properly 2. Verify the Dialysate Connectors are
positioned. properly positioned to the dialyser or to the
machine, depending upon the phase of the
machine at that time. Press RESTART to
restart the current operation of the
machine.
3. Massive air leak. 3. Verify the presence of air in the external
Dialysate line (TO/FROM). Press RESTART
to restart the current operation of the
machine.
Rev. B
Heart Rate Alarm 66
Reason The BPM heart rate measurement is outside the limits set by the operator.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The BPM heart rate measurement is outside 1. Press OVERRIDE to clear the alarm. Verify
the limits set by the operator. the heart rate with a manual measurement,
compare it with the BPM heart rate. If both
readings are close, consider changing the
heart rate limits for this patient in the SET
mode from the BPM view.
2. The cuff is improperly applied. 2. Check cuff application, repeat
measurement.
3. The patient moved during the 3. Retry measurement.
measurement.
4. The blood pressure cuff is not working 4. Take a manual pulse rate. Replace the
properly or has a leak. tubing and cuff if necessary.
Rev. B
HEATING SYSTEM NOT STARTED 67
Reason This alarm displays if the hydraulic flowpath temperature falls below 90C for 5
for Alarm minutes during HEAT Disinfection.
Machine The machine will go to a RESTART condition.

Actions
Possible Suggested
Cause Action
1. The hydraulic flowpath temperature falls 1. Press RESTART to reset to normal operating
below 90C for 5 minutes during HEAT conditions. If the alarm occurs again, turn
Disinfection. OFF the machine and then ON. Repeat the
ADR procedure.
Rev. B
DIALYSER SAFETY PRESSURE 68
Reason The transmembrane pressure difference of the blood side to the dialysate side is
for Alarm larger than the value set by the operator for the HD SAFE THRE.
Machine None.
Actions
Possible Suggested
Cause Action
1. The HD SAFE THRE. is incorrect for the 1. Verify that the correct HD SAFE THRE.
dialyser used. value was selected and entered in Config
for the dialyser used.
2. The blood flow rate is too high for the 2. Verify the correctness of the patient
current dialyser in the current operating prescription (ultrafiltration rate). Consider
condition. decreasing the blood flow if this operation
is not in disagreement with the patient
prescription to decrease the venous
pressure and avoid hemoconcentration.
3. The ultrafiltration is too high for the current 3. Verify the correctness of the patient
dialyser in the current operating condition. prescription (ultrafiltration rate).
4. The transmembrane pressure is too high. 4. Consider increasing the dialysate flow to
increase the dialysate pressure.
5. The extracorporeal circuit is clotting (low 5. Check the extracorporeal circuit for
flux dialyser). clotting. Refer to your internal policy.
Rev. B
HEPARIN PUMP DIRECTION ERROR 69
Reason The Heparin Pump motor is rotating in the wrong direction.

for Alarm

Actions
Possible Suggested
Cause Action
1. The Heparin Pump motor is rotating in the 1. Deactivate the heparin program. Activate it
wrong direction. again. If the problem persists deactivate the
heparin program.
Rev. B
HEPARIN SPEED ERROR 70
Reason Actual Heparin Pump infusion rate is incorrect.

for Alarm

Actions
Possible Suggested
Cause Action
1. Actual Heparin Pump infusion rate is 1. Deactivate the heparin program. Activate it
incorrect. again. If the problem persists, deactivate
the heparin program.
2. Blocked heparin line or the clamp is closed. 2. Verify that the heparin clamp on the 4
Position Line Clamp is open and the
heparin line is open.
Rev. B
HEPARINISATION NOT STARTED 71
Reason The machine is in DIALYSIS, sensing blood at the Patient Sensor and the Heparin
for Alarm Pump has not been turned ON.
Machine None.
Actions
Possible Suggested
Cause Action
1. Heparin infusion was not started at the 1. In heparin view, start the heparin program
beginning of the treatment. and press OVERRIDE to clear the alarm.
2. No heparin program is needed. 2. Press OVERRIDE to clear the alarm.
Note
In Config, the HEPARIN ALARM parameter can be configured to NO or YES. If set to NO, the
Heparinisation Not Started alarm is turned off and will not appear.
Rev. B
HIGH LEVEL IN DIS TANK 72
Reason The state of the high level sensor in the disinfectant tank is not as required for the
for Alarm current phase.
Machine In ADR: The Time Out Proc (#190) alarm is displayed and the machine
Actions stops.
In Dialysis: None.
Possible Suggested
Cause Action
1. In ADR: the disinfectant container is empty. 1. Check the level of the disinfectant
container. Press RESTART to proceed with
the current process.
2. In ADR: disinfectant connector not 2. Verify the Disinfectant Connector is
attached to the Disinfectant Wand. properly positioned to the Disinfectant
Wand. Press RESTART to proceed with the
current process.
3. In dialysis preparation: the machine had 3. Run a complete RINSE procedure.
been shut off when the tank was full or not
completely rinsed out.
4. In dialysis preparation: the Level Sensor is 4. Stop the dialysis preparation and run a
dirty or defective. complete RINSE procedure. If the problem
persists call for Service.
5. In DIALYSIS: If the Visual and Audible 5. Wait for the end of the treatment. After
alarms are triggered press OVERRIDE. WASHBACK, try to perform a RINSE
procedure.
Rev. B
HIGH LEVEL IN UF VESSEL 73
Reason Problem indicated with the High Level Sensor in the UF burette.
for Alarm
Actions stops.
In Dialysis: None.
Possible Suggested
Cause Action
1. In ADR: Error detected by the High Level 1. Press RESTART to restart the process.
Sensor in the UF burette.
Rev. B
! LONG POWER FAILURE 80
Reason An interruption of the AC supply voltage for more than 20 seconds.

for Alarm

Actions
Ultrafiltration pump is reduced to its minimum value.
Bypasses dialyser.
Note
This alarm occurs only if the Battery Backup Kit is not installed.
WARNING
When AC power is interrupted, a continuous audible alarm is turned ON.
Possible Suggested
Cause Action
1. Loss of AC power. 1. When power is restored, press OVERRIDE
to restart the dialysis treatment.
2. The plug has been disconnected, or the 2. Verify the plug is properly positioned in the
main switch (beside the socket) has been socket and the switch is turned on. Press
turned off. OVERRIDE to restart the dialysis treatment.
Rev. B
LOW TEMPERATURE LIMIT REACHED 81
Reason This alarm appears if, in Chemical Disinfection with heating, the hydraulic flowpath
for Alarm temperature falls below 33C.
Machine The process time will stop until the temperature measured in the hydraulic
Actions circuit reaches 36C.
Possible Suggested
Cause Action
1. Temporary drop of the temperature. 1. No Action is required. The machine should
heat automatically.
Rev. B
LOW LEVEL IN DIS TANK 82
Reason The state of the Low Level Sensor in the Disinfectant Tank is not as required for the
for Alarm current phase.
Actions stops.
In Dialysis: None
Possible Suggested
Cause Action
1. In ADR: the Disinfectant Container is 1. Check that an adequate amount of
empty. disinfectant is present in the Disinfectant
Container. Press RESTART to proceed with
the current process.
2. In ADR: the Disinfectant Connector is not 2. Verify that the Disinfectant Connector is
attached to the Disinfectant Wand or the properly connected to the Disinfectant
Wand is not positioned properly for the Wand and that the Wand is submerged in
level of disinfectant present. the disinfectant. Press RESTART to proceed
with the current process.
3. In dialysis preparation the machine was 3. Run a complete RINSE procedure.
shut off when the tank was full or not
completely rinsed out.
4. In dialysis preparation: the Level Sensor is 4. Stop the dialysis preparation and run a
dirty or defective. complete RINSE procedure. If the problem
persists call for Service.
5. In DIALYSIS: If the Visual and Audible 5. Wait for the end of the treatment. After
alarms occur, press OVERRIDE. WASHBACK, try to perform a RINSE
procedure.
Rev. B
LOW LEVEL IN UF VESSEL 83
Reason Problem indicated with the Low Level Sensor in the UF Burette
for Alarm
Actions stops.
In Dialysis: None.
Possible Suggested
Cause Action
1. In ADR: Error detected by the low level 1. Press RESTART to restart the process.
sensor in the UF burette.
Rev. B
LOW PRESSURE IN DEGASSER 84
Reason Low flow as seen by LFP (for more than 6 seconds) is indicated in the degassing
for Alarm portion of the hydraulics.
Machine The heater is turned OFF, the machine stops and goes into a RESTART
Actions condition.
Possible Suggested
Cause Action
1. Problem in the degassing loop. 1. Press RESTART to restart the process.
WARNING
Rev. B
MAX PI PRESSURE 87
Reason The hydraulic pressure sensor PI has detected a higher pressure than what is
for Alarm allowed at the dialyser inlet connector.
Machine In DIALYSIS:
Actions If the pressure is greater than 450 mmHg, the UF Pump is driven at the
current value.
If the pressure is greater than 500 mmHg, the UF Pump is driven at the
current value and the machine goes into the RESTART phase.
In ADR:
If the pressure is greater than 500 mmHg the machine will stop the
hydraulic module pumps and the UF Pump. The machine goes into the
RESTART.
Possible Suggested
Cause Action
1. Dialysate Connectors in the wrong 1. Verify Dialysate Connectors are in the
position. proper position for the current phase of the
machine, then press RESTART.
2. Dialysate Connectors in the proper 2. Verify Dialysate Connectors are well fitted
position, but not well inserted. to the dialyser or to the machine,
3. External Dialysate Lines are kinked. 3. Verify external Dialysate Lines are not
kinked, then press RESTART.
4. Massive presence of air inside the hydraulic 4. Verify the presence of air in external
circuit. Dialysate Line, then press RESTART.
5. The blood flow is too high, producing a 5. Verify the correctness of the patient
overpressure on the hydraulic side of the prescription (ultrafiltration rate). Consider
machine. reducing the blood flow if this operation is
not in disagreement with the patient
prescription.
6. Clotting or clogging in the blood side of the 6. Check for clotting or clogging in the blood
dialyser. side of the dialyser. Change the dialyser if
necessary
7. The dialysate flow rate is not correct for the 7. Consider reducing the dialysate flow rate.
current dialyser.
8. Incorrect placement of the diaphragm 8. Perform a diaphragm Neutralization
between the Cartridge Blood Set and the procedure (See Section 5.A Special
venous seal. Procedures, in this manual).
WARNING
When the patient is connected, if the first selection of the RESTART key doesnt clear the alarm, re-
check carefully all the possible causes of the alarm then press again the RESTART key. Never press
the RESTART key more than 2 or 3 times if the problem that is causing the RESTART condition
has not been identified.
Rev. B
MAX PO PRESSURE 88
Reason The pressure sensor Po has detected a higher pressure than what is allowed at the
for Alarm dialyser outlet connector.
Actions If the pressure is greater than 450 mmHg, the UF Pump is driven at the
current value.
If the pressure is greater than 500 mmHg, the UF Pump is driven at the
current value and the machine goes into the RESTART phase.
In ADR:
If the pressure is greater than 500 mmHg the machine will stop the
hydraulic module pumps and the UF Pump. The machine goes into the
RESTART.
Possible Suggested
Cause Action
1. Dialysate Connectors in the wrong 1. Verify Dialysate Connectors are in the
2. Dialysate Connectors in the proper 2. Verify Dialysate Connectors are well fitted
position, but not well inserted. to the dialyser or to the machine,
3. External dialysate lines are kinked. 3. Verify external dialysate lines are not
4. Massive presence of air inside the hydraulic 4. Verify the presence of air in the external
circuit. dialysate line, then press RESTART.
5. The blood flow is too high, producing a 5. Verify the correctness of the patient
overpressure on the hydraulic side of the prescription (ultrafiltration rate). Consider
machine. reducing the blood flow if this operation is
not in disagreement with the patient
prescription.
dialyser. side of the dialyser. Replace the dialyser if
necessary.
current dialyser.
WARNING
When the patient is connected, if the first selection of the RESTART key doesnt clear the alarm, re-
check carefully all the possible causes of the alarm then press again the RESTART key. Never press
the RESTART key more than 2 or 3 times if the problem that is causing the RESTART condition
has not been identified.
Rev. B
MAX TEMPERATURE LIMIT 90
Reason The temperature measured by TP is greater than the following maximum values:
for Alarm 1. In DIALYSIS 46C (114.8F)
2. In Chemical Disinfection 42C (107.6F)
3. In Heat or Heat Citric Disinfection 110C (230F)
Machine The heater is turned OFF.

Actions
Possible Suggested
Cause Action
1. The machine had a RESTART condition. 1. Verify patient safety. Verify a previous
RESTART condition. Wait for the
temperature to drop; the heater is
automatically turned on.
2. The machine has malfunctioned. 2. Discontinue DIALYSIS and call for Service.
3. Incoming water temperature is too high. 3. Check the incoming water temperature
(See the Specifications section).
Rev. B
MIN PI PRESSURE 94
Reason The pressure sensor Pi has detected a lower pressure (approximately -350 mmHg)
for Alarm than what is allowed at the inlet of the dialyser.
Actions When the Dialysate flow is greater than 400 ml/min and the pressure is
lower than -350 mmHg, the UF Pump is stopped.
When the Dialysate flow is lower than or equal to 400 ml/min and the
pressure is lower than -250 mmHg, the UF Pump is stopped and the
machine goes into bypass.
If the pressure is lower than -450 mmHg, the UF Pump is stopped and the
machine goes into the RESTART condition.
In ADR:
The pumps in the hydraulic module are stopped and the machine goes into
the RESTART condition.
Possible Suggested
Cause Action
1. Dialysate Connectors in the wrong 1. Verify the Dialysate Connectors are in the
2. Dialysate Connectors in the proper 2. Verify the Dialysate Connectors are well
position, but not well inserted. fitted to the dialyser or to the machine,
3. External dialysate lines are kinked. 3. Verify the external dialysate lines are not
5. The UF Rate is too high for the dialyser 5. Check the proper UF Rate for the dialyser
used. used. Consider reducing the blood flow if
this operation is not in disagreement with
the patient prescription then press
RESTART.
necessary.
7. The dialysate flow is not correct for the 7. Consider reducing the dialysate flow rate.
current dialyser.
WARNING
Rev. B
MIN PO PRESSURE 95
Reason The pressure sensor Po has detected a lower pressure (approximately -350 mmHg)
for Alarm than what is allowed at the outlet of the dialyser.
Actions When the Dialysate flow is greater than 400 ml/min and the pressure is
lower than -350 mmHg, the UF Pump is stopped.
When the Dialysate flow is lower than or equal to 400 ml/min and the
pressure is lower than -250 mmHg, the UF Pump is stopped and the
machine goes into bypass.
If the pressure is lower than -450 mmHg, the UF Pump is stopped and the
machine goes into the RESTART condition.
In ADR:
The pumps in the hydraulic module are stopped and the machine goes into
the RESTART condition.
Possible Suggested
Cause Action
1. Dialysate Connectors in the wrong 1. Verify the Dialysate Connectors are in the
2. Dialysate Connectors in the proper 2. Verify the Dialysate Connectors are well
position, but not well inserted. fitted to the dialyser or to the machine,
3. External dialysate lines are kinked. 3. Verify the external dialysate lines are not
5. The UF Rate is too high for the dialyser 5. Check the proper UF Rate for the dialyser
used. used. Consider reducing the blood flow if
this operation is not in disagreement with
the patient prescription, then press
RESTART.
necessary.
current dialyser.
WARNING
-
Rev. B
NO WATER 100
Reason No water in the hydraulic circuit. Water pressure is low.

for Alarm
Machine All hydraulic module pumps are stopped.

Actions In DIALYSIS: the machine bypasses the dialyser.
Possible Suggested
Cause Action
1. Pressure drop in the RO distribution 1. Verify that there is adequate water pressure
system. in the RO distribution system
2. The inlet water is disconnected. 2. Connect the inlet water to proper water
valve.
3. The water valve is closed. 3. Verify the water valve is open.
4. The incoming water filter is clogging. 4. Check the water filter in the machine for
clogging. A clogged filter will decrease the
amount of water flowing through the
system.
Note
In DIALYSIS press RESTART to continue the treatment after the problem is fixed. In ADR the
machine restarts automatically.
Rev. B
P1 PUMP OUT OF ORDER 104
Reason The encoder on P1 does not indicate the proper response to the command to run
for Alarm P1, or P1 pump does not guarantee the dialysate flow set value, thus indicating
malfunctioning.
Machine In ADR: The machine stops and goes into a RESTART condition.
Possible Suggested
Cause Action
1. In DIALYSIS: P1 pump does not work 1. Consider completing the treatment by
properly in order to guarantee the dialysate setting the dialysate flow to 500 ml/min if
flow set value. this operation is not in disagreement with
the patient prescription; at the end of the
treatment call for Service. If it is not
possible to modify the patient prescription,
stop the treatment and call for Service.
2. In DIALYSIS: failure on the command that 2. If the alarm does not clear see the Fast
drives the pump P1. Recovery of the Dialysis process procedure
in the Special Procedures section.
3. In ADR: failure on the command that drives 3. Press RESTART to restart the current
the pump P1. operation of the machine.
4. In ADR: if the machine does not restart. 4. Turn OFF the machine, wait a few seconds,
turn it ON again and repeat the procedure
to perform.
Rev. B
P2 PUMP OUT OF ORDER 106
Reason The encoder on P2 does not indicate the proper response to the command to run
for Alarm P2, thus indicating malfunctioning.
Possible Suggested
Cause Action
1. In DIALYSIS: failure of the command that 1. If the alarm does not clear see the Fast
drives the P2 Pump. Recovery of the Dialysis process procedure
in the Section 5.A Special Procedures.
2. In ADR: failure of the command that drives 2. Press RESTART to restart the current
the P2 Pump. operation of the machine.
turn it ON again and repeat the procedure
to perform.
Rev. B
PA AUTOCALIBRATION NOT PERFORMED 107
Reason The self calibration of the PA pump has not been performed due to a problem in
for Alarm the EEPROM of the Protective board.
Machine None.
Actions
Possible Suggested
Cause Action
1. The autocalibration of the Acid/Acetate 1. Repeat the PA autocalibration.
Pump failed.
Rev. B
PA PUMP OUT OF ORDER 108
Reason The PA Pump does not respond to commands.

for Alarm
Possible Suggested
Cause Action
1. In ADR, Acid/Acetate Pump failed. 1. In ADR, press RESTART to restart the
current operation of the machine.
2. Acid/Acetate Pump failed but RESTART 2. Turn OFF the machine, wait a few seconds,
does not fix the problem. turn it ON again and repeat the procedure
to perform.
Rev. B
PB AUTOCALIBRATION NOT PERFORMED 109
Reason The self calibration of the PB Pump has not been performed due to a problem in
for Alarm the EEPROM of the protective board.
Machine None.
Actions
Note
This alarm only occurs when using liquid bicarbonate concentrate.
Possible Suggested
Cause Action
1. The autocalibration of the Bicarbonate 1. Repeat the PB autocalibration.
Pump failed.
Rev. B
PB PUMP OUT OF ORDER 110
Reason The PB Pump does not respond to commands.

for Alarm
Possible Suggested
Cause Action
1. Bicarbonate Pump failed. 1. In ADR, press RESTART to restart the
2. Bicarbonate Pump failed but RESTART does 2. Turn OFF the machine, wait a few seconds,
not fix the problem. turn it ON again and repeat the procedure
to perform.
Rev. B
PC PUMP FAILURE 111
Reason The encoder on the PC does not indicate the proper response to the command to
for Alarm run the PC, thus indicating a malfunction.
Possible Suggested
Cause Action
1. In DIALYSIS: failure of the command that 1. If the alarm does not clear see the Fast
drives the PC Pump. Recovery of the Dialysis process procedure
in the Section 5.A - Special Procedures.
2. In ADR: failure of the command that drives 2. Press RESTART to restart the current
the PC Pump. operation of the machine.
turn it ON again and repeat the procedure.
Rev. B
PH MAXIMUM ALARM 112
Reason This alarm only occurs during Chemical or Heat Citric Disinfection. The pH value
for Alarm measured is greater than the maximum SET in the parameters.
Machine In Chemical or Citric Disinfection, the machine will go to a RESTART

Actions condition.
Possible Suggested
Cause Action
1. The pH value measured is greater than the 1. Verify that the chemical is the correct type
maximum SET in the parameters. to be used. Press RESTART to restart the
current operation of the machine. If the
problem persists, discontinue the process.
2. The pH Max parameter value is not correct 2. Consider changing the pH Max parameter
for the chemical being used. value in relation to the chemical being used
for that process.
Rev. B
PH MINIMUM ALARM 113
Reason This alarm only occurs during Chemical or Heat Citric Disinfection. The pH value
for Alarm measured is less than the minimum SET in the parameters.
Machine In Chemical or Citric Disinfection, the machine will go to a RESTART

Actions condition.
Possible Suggested
Cause Action
1. The pH value measured is lower than the 1. Verify that the chemical is the correct type
maximum SET in the parameters. to be used. Press RESTART to restart the
current operation of the machine. If the
problem persists, discontinue the process.
2. The pH Min parameter value is not correct 2. Consider changing pH Min parameter
for the chemical used. value in relation to the chemical being used
for that process.
Rev. B
! PI PO MAX 114
Reason The dialyser inlet/outlet pressure has exceeded the maximum limit of +480 mmHg.
for Alarm
Machine None.
Actions
Note
In case of high pressure detected by Pi or by Po, the #87 alarm (in case of high pressure detected
by Pi) or the #88 alarm (in case of high pressure detected by Po) often occurs just before the #114
alarm appearance. Moreover, if the pressure detected becomes highter than +500 mmHg, the
machine goes into RESTART condition and the RESTART window becomes available. Refer also to
the #87 or #88 alarm description to exit from the alarm condition.
Possible Suggested
Cause Action
1. Dialysate Connectors not in the proper 1. Verify the Dialysate Connectors are in the
position or not well inserted. proper position and are well fitted to the
dialyser or to the machine, depending upon
the phase of the machine at that time.
2. External Dialysate Lines are kinked. 2. Verify the external Dialysate Lines are not
kinked.
circuit. Dialysate line. Verify the Dialysate
Connectors are well fitted to the dialyser or
to the machine.
4. The UF Rate is too low. 4. Verify the correctness of the patient
prescription (ultrafiltration rate). Consider
reducing the Blood Pump speed if this
operation is not in disagreement with the
patient prescription.
5. Clotting or clogging in the dialyser and/or 5. Check for clotting or clogging in the blood
Cartridge Blood Set. side of the dialyser or in the Cartridge
Blood Set. Change the dialyser and the
Cartridge Blood Set if necessary.
current dialyser.
Rev. B
! PI PO MIN 115
Reason The dialyser inlet/outlet pressure is below the minimum limit of -350 mmHg.
for Alarm
Machine Ultrafiltration is stopped.

Actions
Note
In case of low pressure detected by Pi or by Po, the #94 alarm (in case of low pressure detected
by Pi) or the #95 alarm (in case of low pressure detected by Po) often occurs just before the #115
alarm appearance. Moreover, if the pressure detected becomes lower than -450 mmHg, the
machine goes into RESTART condition and the RESTART window becomes available. Refer also to
the #94 or #95 alarm description to exit from the alarm condition.
Possible Suggested
Cause Action
1. Dialysate Connectors not in the proper 1. Verify the Dialysate Connectors are in the
position or are not inserted well. proper position and are well fitted to the
dialyser or to the machine, depending upon
the phase of the machine at that time.
2. External Dialysate Lines are kinked. 2. Verify the external Dialysate Lines are not
kinked.
circuit. Dialysate Lines. Verify the Dialysate
Connectors are well fitted to the dialyser or
to the machine.
4. The UF Rate is too high for the dialyser 4. Verify the correctness of the patient
used. prescription (ultrafiltration rate). Consider
increasing the Blood Pump speed if this
5. Clotting or clogging in the dialyser or the 5. Check for clotting or clogging in the blood
Cartridge Blood Set. side of the dialyser or in the Cartridge
Blood Set. Replace if necessary.
6. The dialysate flow rate is not correct for the 6. Consider increasing the dialysate flow rate.
current dialyser.
Rev. B
PI PRESSURE SENSOR ERROR 116
Reason A problem was detected with the Inlet Dialyser Pressure Sensor due to an
for Alarm unplugged Sensor or to an out of range reading.
Machine None.
Actions
Possible Suggested
Cause Action
1. Problem detected with the Inlet Sensor of 1. No action is required.
the dialyser.
Rev. B
PO PRESSURE SENSOR ERROR 118
Reason A problem was detected with the Outlet Dialyser Pressure Sensor due to an
for Alarm unplugged Sensor or to an out of range reading.
Machine None.
Actions
Possible Suggested
Cause Action
1. Problem detected with the Outlet Sensor of 1. No action is required.
the dialyser.
Rev. B
! PROTECTIVE CARD COMM. TIMEOUT 120
Reason The Protection System is not able to communicate with the Main computer Board.
for Alarm

Actions Stops the Ultrafiltration Pump.
Stops the Blood Pump.
Note
The Audible alarm, which signals the #120 alarm condition, can not be silenced by pressing the
MUTE button.
Note
This alarm is usually followed by a > GENERAL SAFE STATE < alarm.
Possible Suggested
Cause Action
1. Temporary instability of the communication 1. Wait few seconds for stability of the
system. communication system.
2. The machine blocks and goes into > 2. See the Fast Recovery of the Dialysis
GENERAL SAFE STATE <. process procedure in the Section 5.A -
Special Procedures. If the condition
persists, stop DIALYSIS.
Rev. B
PUF AUTOCALIBRATION NOT PERFORMED 121
Reason The Ultrafiltration Pump Autocalibration was not performed due to a problem in
for Alarm the EEPROM of the Protective board.
Machine None.
Actions
Possible Suggested
Cause Action
1. The Autocalibration of the Ultrafiltration 1. Repeat the PUF Autocalibration. If
Pump failed. necessary, turn OFF the machine.
Rev. B
PUF PUMP OUT OF ORDER 122
Reason The Ultrafiltration Pump does not respond to commands.

for Alarm
Possible Suggested
Cause Action
1. Ultrafiltration Pump failed. 1. In ADR: press RESTART to restart the
2. Ultrafiltration Pump failed but RESTART 2. Turn OFF the machine, wait a few seconds,
does not fix the problem. turn it ON again and repeat the procedure.
Rev. B
! SHORT POWER FAILURE 124
Reason A drop in AC voltage for less than 20 seconds.

for Alarm

Actions
Note
This alarm occurs only if the Battery Backup Kit is not installed.
WARNING
When AC power drops out, a continuous audible alarm is turned on.
Possible Suggested
Cause Action
1. Loss of AC power less than 20 seconds. 1. Press OVERRIDE to restart the dialysis
treatment.
2. The plug has been disconnected, or the 2. Verify that the plug is properly positioned
breaker switch (beside the socket) has been in the socket and the switch is turned on.
turned off. Press OVERRIDE to restart the dialysis
treatment.
Rev. B
! SN COMMUTATION 125
Reason The maximum run time for a cycle in Single Needle mode has elapsed.
for Alarm

Actions
Ultrafiltration is reduced to its minimum value.
Possible Suggested
Cause Action
1. The expansion chambers may be leaking 1. Verify the expansion chambers are not
air, causing the stroke to be too long. The leaking. Adjust the levels inside the
chamber will fill up over time. expansion chambers.
2. A previous alarm stopped the Blood Pump. 2. Press OVERRIDE to restart the Pump and
clear the alarm.
3. The Blood Pump speed is too low for the 3. Increase the Blood Pump speed, or
venous limits set by the operator. consider changing the venous limits.
4. The venous line is kinked. The machine 4. Verify the venous line is not kinked.
cannot reinfuse the blood to the patient
after clamp commutation.
5. Clotting is occuring in the Cartridge Blood 5. Verify that there is no clotting in the
Set. Cartridge Blood Set.
6. The patient is moving around. 6. Press OVERRIDE to restart the pump and
clear the alarm.
7. The blood levels in the arterial and venous 7. Press OVERRIDE to restart the pump and
chambers were adjusted while the Blood clear the alarm. Slowly adjust the arterial
Pump was running. and venous chamber blood levels, using a
syringe.
8. A combination of Blood Pump speed, 8. Increase the Blood Pump speed, change
venous high and low trip points, and UF the venous trip points, or decrease the UF
RATE has caused the SN cycle time to RATE to reduce the SN cycle time to within
exceed the allowed cycle time. the allowed time limit.
9. Arterial and/or venous lines are not in their 9. Press OVERRIDE to restart the pump and
clamps. clear the alarm. Place the line(s) in the
clamp(s).
10. A change was made to the UF RATE. 10. Press OVERRIDE to restart the pump and
clear the alarm.
Rev. B
START DIALYSIS DELAYED 129
Reason The Patient Sensor has detected blood for at least 5 minutes and the DIALYSIS
for Alarm Action key on the PATIENT CONNECT view has not been pressed.
Machine None.
Actions
Possible Suggested
Cause Action
1. The Patient Sensor has detected blood for 1. Select the DIALYSIS Action key.
at least 5 minutes and the DIALYSIS Action
key on the PATIENT CONNECT view has
not been pressed.
2. Problems during patient connection 2. Fix problems in patient connection, then
postponed the start of dialysis. start the treatment.
Rev. B
BLOOD CARD MSG TRANFER ERROR 130
Reason The Main computer and the Blood Slave Board are not communicating.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary communication problem. 1. Wait a few seconds for the alarm to be
cleared.
2. If alarm does not clear and the machine 2. See the Fast Recovery of the Dialysis process
stops functioning. procedure in the Section 5.A - Special
Procedures.
Rev. B
HYD CARD MSG TRANSFER ERROR 131
Reason The Main computer Board and the hydraulic modules are not communicating.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
cleared.
2. If alarm does not clear and the machine 2. See the Fast Recovery of the Dialysis
stops functioning. process procedure in the Section 5.A -
Special Procedures.
Rev. B
SYSTOLIC PRESSURE ALARM 132
Reason The systolic pressure measurement taken by the BPM device is outside the limits
for Alarm set by the operator in the Configuration view.
Machine None.
Actions
Possible Suggested
Cause Action
1. The patients systolic pressure is out of the 1. Press OVERRIDE to reset the alarm. Verify
range set in configuration. the measurement with a manual blood
pressure cuff. Refer to your internal policy.
Retry the measurement.
2. The cuff is improperly applied. 2. Check and/or reapply the cuff on the
patients extremity. Press OVERRIDE to
reset the alarm. Retry the measurement.
3. Patient moved during the measurement. 3. Press OVERRIDE to reset the alarm. Retry
the measurement.
4. The blood pressure cuff is not working 4. Replace the cuff and tubing and retry the
properly. measurement.
Take a comparison blood pressure reading
with a correctly calibrated manual
sphygmomanometer. If the readings are not
similar, call for Service.
Rev. B
! T1 TEST FAILED 133
Reason One of the automatic T1 tests of the machines components and processes has
for Alarm failed.
Machine GENERAL SAFE STATE

Actions
Possible Suggested
Cause Action
1. A T1 test failed during preparation. 1. Verify that the Dialysate Connectors are
properly positioned to their Bypass Ports.
Repeat Dialysate preparation. If the T1 test
fails again, note the T1 test failed and call for
Service.
2. A Fast Recovery of the Dialysis process was 2. The venous line must stay inside the Air
performed, but the venous line was out of Bubble Detector. A new Fast Recovery of
the Air Bubble Detector. the Dialysis process procedure is required.
If the blood is clotting, disconnect the
patient.
Rev. B
! TEMPERATURE 134
Attribute MINIMUM
MAXIMUM
UNDEFIN
Reason Minimum
for Alarm The measured temperature is -2C lower than the set value or the minimum
permitted value (34C).
Maximum
The measured temperature is +2C above than the set value or the maximum
permitted value (39.5C).
Undefin
The machine is unable to measure the temperature.

Actions
Possible Suggested
Cause Action
1. A temporary instability of dialysate flow due 1. Wait for stability of the system.
to a previous RESTART condition.
2. The temperature of the dialysate has 2. Check the incoming water temperature (See
exceeded safe limits. the Section 9 - Specifications).
3. The machine has recently been turned on 3. If the machine temperature remains high or
and has not yet reached operating low for more than 10 minutes, discontinue
temperature. dialysis.
4. The machine has an internal malfunction 4. Discontinue dialysis.
Rev. B
! TEMPERATURE DATA ERROR 135
for Alarm in the Main Board, for the TEMPERATURE parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In SET mode, restore the parameter to the
the Main Board, for the TEMPERATURE the machine.
parameter.
2. The machine has an internal malfunction. 2. Discontinue DIALYSIS.
Rev. B
! TEMPERATURE EXCESSIVE VALUE 136
Reason In DIALYSIS:
for Alarm The protection probe (TPS) temperature was greater than 50C for at least 30
seconds.
Not in DIALYSIS:
The protection probe (TPS) temperature was greater than 105C for at least 30
seconds.
The temperature measured by the Hydraulic Probe was greater than 107C for at
least 5 minutes.
The temperature measured by the Hydraulic Probe was greater than 80C with a
variation of less than 0.1C for at least 5 minutes.

Actions
Possible Suggested
Cause Action
1. In dialysis: a previous RESTART condition 1. See the Fast Recovery of the Dialysis
made the dialysate flow rate unstable. process procedure in the Section 5.A -
Special Procedures. If the problem persists
disconnect the patient.
2. The temperature of the dialysate has 2. Check the incoming water temperature.
exceeded safe limits. (See the Section 9 - Specifications).
3. The machine has an internal malfunction. 3. Discontinue DIALYSIS.
Rev. B
ULTRAFILTER IS PACKED 138
Reason The pressure drop across the Clean Dialysate Ultrafilter is higher than the
for Alarm maximum permitted value.
Machine In DIALYSIS and ADR:

Actions The machine goes into a RESTART condition.
Possible Suggested
Cause Action
1. The Clean Dialysate Ultrafilter is plugged. 1. If treatment has started, the dialysis process
in progress can be continued by decreasing
the dialysate flow rate. When the treatment
is complete, replace the Ultrafilter according
to the procedure.
Rev. B
TIMEOUT ON PA AUTOCALIBRATION 139
Reason The PA Pump Autocalibration has failed due to the timeout of the Main Board.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Concentrates were changed during the 1. Wait a few seconds for stability of the
Autocalibration or the machine has run out machine, check for the correct Acid/Acetate
of concentrates. Container, and then repeat the PA
Autocalibration. If needed reboot the
machine and repeat the PA Autocalibration.
2. Conductivity is not stable during the 2. Verify the Acid/Acetate Connector is well
Autocalibration. inserted in the proper Wand, verify the
stability of Acid/Acetate conductivity, then
repeat the PA Autocalibration. If needed
reboot the machine and repeat the PA
Autocalibration.
3. Power failure during PA Pump 3. Turn the machine OFF and then back ON
Autocalibration. and perform PA Autocalibration again.
Rev. B
TIMEOUT ON PB AUTOCALIBRATION 140
Reason The PB Pump Autocalibration has failed due to the timeout of the Main Board.
for Alarm
Machine None.
Actions
Note
This alarm will only occur if Liquid Bicarbonate is being used.
Possible Suggested
Cause Action
1. Concentrates were changed during the 1. Wait a few seconds for the machine to
Autocalibration or the machine has run out stabilize, check for the correct Bicarbonate
of concentrates. Concentrate, and then repeat the PB
Autocalibration. If needed, turn the machine
OFF and then back ON and repeat the PB
Autocalibration.
2. Conductivity is not stable during the 2. Verify the Bicarbonate Connector is well
Autocalibration. inserted in the proper Wand, verify the
stability of the Bicarbonate Conductivity,
then repeat the PB Autocalibration. If
needed turn the machine OFF and then
back ON and repeat the PB Autocalibration.
3. Power failure during PB Pump 3. Turn the machine OFF and then back ON
Autocalibration. and perform the PB Autocalibration again.
Rev. B
TIMEOUT ON PUF AUTOCALIBRATION 141
Reason The PUF Pump Autocalibration has failed due to the timeout of the Main Board.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The tubing segment in the PUF Peristaltic 1. Perform a RINSING procedure, and then
Pump is new, and needs to be stretched. repeat the PUF Autocalibration.
2. In a previous RESTART condition the 2. From IDLE view, restart the Dialysis
Autocalibration failed. preparation and the PUF Autocalibration.
3. Power failure during PUF Pump 3. Turn the machine OFF and then back ON
Autocalibration. and perform the PUF Autocalibration again.
Rev. B
TRANSMEMBRANE PRESSURE 142
Reason The difference between the venous pressure and the Pi Pressure Transducer has
for Alarm reached the TMP THRESHOLD parameter set by the user.
Machine None.
Actions
Note
If the parameter TMP ALARM is set to NO in the configuration process, when the alarm appears
once, it can be reset and then does not appear again; if the parameter is set to YES, it is not
possible to override the alarm, it will be displayed on the Touch Screen as long as the alarm
condition persists. The TMP icon and visual alarm are displayed if the TMP ALARM is set YES or
NO.
Note
The Transmembrane Pressure alarm is not active if the machine is in Single Needle mode.
Possible Suggested
Cause Action
1. Dialyser not correct for the current 1. Verify the correctness of the patient
treatment. prescription (ultrafiltration rate). Consider
increasing the Blood Pump speed if this
patient prescription. Comply with the
specifications of the dialyser.
2. TMP THRESHOLD parameter does not 2. Consider changing the limit of this
comply with the specification of the dialyser. parameter in the Config menu.
3. Blood Pump is stopped. 3. Correct the action which caused the Blood
Pump to stop and restart the Blood Pump.
4. The Dialysate Lines are blocked. 4. Check that the Dialysate Lines are not
kinked or clamped.
5. The Alarm limit is set too close to the actual 5. Readjust the alarm limit.
TMP.
6. The Cartridge Blood Set is not well 6. If the alarm condition persists, verify the
positioned or a pressure pod diaphragm has Cartridge Blood Set position. Verify that the
collapsed. The Pressure Sensor cannot read pressure pod diaphragm are not collapsed.
properly. Perform the Diaphragm Neutral Position
Procedure (See Section 5.A Special
Procedures) if required.
Rev. B
! UF DATA ERROR 143
for Alarm in the Main Board, for the WEIGHT LOSS/H parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In SET mode, confirm the parameter to the
the Main Board, for the WEIGHT LOSS/H the machine.
parameter.
Rev. B
! UF MASS BALANCE 144
Attribute 8. Valves
9. D1-D2
10. P2 Pump
11. No Calib
Reason VALVES:
for Alarm Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect
valves control.
D1-D2:
Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect
flowmeter reading.
P2 Pump:
Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect
P2 Pump flow or P2 reading.
NO CALIB:
The machine could not perform an alignment of the D2 flowmeter during the
treatment, and the Ultrafiltration Mass Balance could be incorrect.

Actions
Note
This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key
is pressed.
Possible Suggested
Cause Action
1. A RESTART condition has resulted in the 1. Press OVERRIDE to clear the alarm.
machine detecting a Ultrafiltration Mass
Balance error.
2. If the attribute is D1-D2 or P2 Pump the 2. If the problem persists disconnect the
machine needs to be descaled. patient. As soon as possible perform
DESCALING.
3. If the attribute is No Calib, the machine has 3. Press OVERRIDE. The machine
not performed a flowmeter alignment for 25 automatically will perform a flowmeter
minutes. alignment.
Rev. B
! UF RATE ERROR 145
Attibute 1. LOW
2. HIGH
3. VESSEL
Reason 1. LOW:
for Alarm The measured ultrafiltration is lower than the rate set by the operator or the
permitted limit.
2. HIGH:
The measured ultrafiltration is higher than the rate set by the operator or the
permitted limit.
3. Vessel:
There was an error detected in the calculation of the volume or the emptying time
of the UF burette.
Machine Ultrafiltration Rate is set to zero.

Actions
Note
is pressed.
Possible Suggested
Cause Action
1. The operator changed the Ultrafiltration 1. Press OVERRIDE to restart the Ultrafiltration
Rate of the machine too often. This is a Pump. The Total Weight Loss calculation
temporary acquiring error. may be affected by this error. If the alarm
persists disconnect the patient, as the Total
Fluid Removal value may not be reliable.
2. Pi and Po pressures are high. The machine 2. Press OVERRIDE to restart the Ultrafiltration
adds approximately 2 liters/hour to the UF Pump.
Rate to lower the pressure. If this occurs
often the alarm could be triggered.
Rev. B
ULTRAFILTER MAX PRESSURE 146
Reason The PFS Pressure Sensor (PFS Sensor is related to the Clean Dialysate Ultrafilter)
for Alarm has registered a measurement which exceeds the maximum permitted value.
Machine In DIALYSIS and ADR:

Actions The machine goes into a RESTART condition.
Possible Suggested
Cause Action
1. The Clean Dialysate Ultrafilter is plugged. 1. If in treatment, the dialysis process in
progress can be continued by decreasing
the dialysate flow rate. When the treatment
is complete, replace the Ultrafilter according
to the procedure.
2. Dialysate Connectors in the wrong position. 2. Correctly connect the dialyser Connectors
to the Bypass Connectors or to the dialyser
3. Dialysate Connectors not properly 3. Verify the Dialysate Connectors are properly
positioned. positioned to the dialyser or to the machine,
at that time. Press RESTART to restart the
Rev. B
ULTRAFILTER PRESSURE SENSOR 147
Reason A problem was detected with the Pre Ultrafilter Pressure Sensor (PFS) due to an
for Alarm unplugged connector or to an out of range reading.
Machine None.
Actions
Possible Suggested
Cause Action
1. Problem detected with the Pre Ultrafilter 1. Press RESTART to restart the current
Sensor. operation of the machine.
WARNING
Rev. B
VENOUS CLAMP POSITION 148
Reason The Optical Switch in the Venous Line Clamp indicates that the clamp is open
for Alarm when it should be closed, or it is closed when it should be open.
Machine None.
Actions
Possible Suggested
Cause Action
1. Venous Line Clamp is obstructed. 1. Verify the Venous Line Clamp is free from
obstruction. Only the venous line should be
inserted into the clamp.
2. Venous Line Clamp is dirty. 2. Carefully clean the Venous Line Clamp (see
Section 6 - Clean/Disinfect, in this manual).
3. The machine has an internal malfunction. 3. Call for service if the problem persists.
Rev. B
! VENOUS PRES DATA ERROR 150
for Alarm in the Main Board, for the VEN P parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. Return to IDLE view, in Config restore the
double image of the Protection System in parameter to the correct value. If the alarm
the Main Board, for the VEN P parameter. persists, and turn the machine OFF, then
back ON again.
Rev. B
! VEN PRES LIMIT DATA ERROR 152
for Alarm in the Main Board, for the VEN PRES LIMIT parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In SET mode, restore the parameter to the
double image of the Protective System in correct value. If the alarm persists, turn the
the Main Board, for the VEN PRES LIMIT machine OFF, then turn it ON again.
parameter.
Rev. B
VEN PRESSURE OUT OF RANGE 153
Reason The measured venous pressure is outside the range of values permitted by the
for Alarm Sensor.

Actions
Ultrafiltration is reduced to the minimum value.
Possible Suggested
Cause Action
1. Restriction of blood flow to the patients 1. Check for restriction of blood flow in the
venous access or in the venous line. venous line, i.e. kinks, clamps, clotted
venous needle, poor flow to the patients
venous access.
The alarm clears when the venous pressure
is in the proper range.
2. Venous pressure has increased somewhat 2. Attention should be given to re-evaluating
during a treatment due to needle size, blood flow rate and
haemoconcentration and/or inadequate anticoagulant dosage.
heparinization of the patient, resulting in a
pressure increase for a given needle at a
fixed blood flow rate.
Rev. B
! VEN PRESSURE LIMIT 154
Reason The Venous Pressure Sensor measured a value that is greater than the VEN PRES
for Alarm LIMIT value set by the operator in the Configuration menu.

Actions
see
Note
Note
The following message appears in the window:
Decrease the Venous Pressure !
Override will only open the Venous Line Clamp if the venous pressure is > VEN PRES LIMIT but
lower than +450 mmHg. When this is the case, the following message is displayed:
Push OVERRIDE To Open The Venous Clamp.
Possible Suggested
Cause Action
1. Restriction of blood flow to the patients 1. Check for restriction of blood flow in the
venous access or in the venous line. venous line, i.e. kinks, clamps, clotted
venous needle, poor flow to the patients
venous access.
Press OVERRIDE to open the Venous
Clamp. The alarm clears when the venous
pressure is in the proper range.
2. Venous pressure has increased somewhat 2. Attention should be given to re-evaluating
during a treatment due to needle size, blood flow rate and
haemoconcentration and/or inadequate anticoagulant dosage.
heparinization of the patient, resulting in a Press OVERRIDE to open the Venous
pressure increase for a given needle at a Clamp. The alarm clears when the venous
fixed blood flow rate. pressure is in the proper range.
WARNING
Never press the OVERRIDE button, to clear the ! VENOUS PRESSURE HIGH LIMIT #154
alarm, if the problem that is causing the alarm condition has not been identified and
removed.
Rev. B
! VEN PRESSURE ALARM 155
Attribute 1. MINIMUM
2. MAXIMUM
3. UNDEFIN
Reason 1. MINIMUM:
for Alarm The Venous Pressure Sensor has measured a pressure value that is lower than
+10 mmHg or which is lower than the minimum range selected by the
operator and displayed in the pressure graph.
2. MAXIMUM:
The Venous Pressure Sensor has measured a pressure value that is higher than
the maximum permitted range selected by the operator and displayed in the
pressure graph.
3. UNDEFIN:
Error in venous pressure acquisition.

Actions
Note
The following message appears in the Operator Messages Area:
Check blood line and patient's access.
Press Override to restart the Pump. If needed
select in SET the graph of the pressure
causing the alarm and press CONFIRM
Possible Suggested
Cause Action
1. If <10 mmHg, venous line may have 1. Carefully check patients line connections.
become disconnected from the patient. Press OVERRIDE to restart the Blood Pump.
2. If high venous pressure, check for kinked 2. Carefully check patients line connections.
venous line. Press OVERRIDE to restart the Blood Pump.
3. Incorrect placement of the diaphragm 3. Perform a Diaphragm Neutral Position
between the Cartridge Blood Set and the Procedure (See Section 5.A Special
Press OVERRIDE to restart the Blood Pump.
4. The venous pressure window needs to be 4. In SET mode, select the venous pressure
set. graph and press CONFIRM.
Press OVERRIDE to restart the Blood Pump.
WARNING
Never press the OVERRIDE button, to clear the ! Ven Pressure Alarm #155 alarm, if the
Rev. B
VEN SENSOR ERROR 159
Reason The control system has detected a large spike or a large rapid change while
for Alarm monitoring the Venous Pressure Sensor.

Actions
Ultrafiltration is reduced to its minimum value.
Possible Suggested
Cause Action
cleared.
Rev. B
! VOLTAGES INCORRECT 160
Reason The Protection Module detects a difference between the reference values and the
for Alarm Power Supply voltages after Patient Connection.

Actions
Possible Suggested
Cause Action
1. Difference between the Protection 1. See Fast Recovery of the Dialysis process
references and the Power Supply voltages. procedure in the Section 5.A - Special
Procedures. Discontinue treatment if the
problem persists.
Rev. B
! WLR MINIMUM DATA ERROR 164
for Alarm in the Main Board, for the WLR MINIMUM parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. Return to IDLE view, in Config menu restore
double image of the Protection System in the parameter to the correct value. If the
the Main Board, for the WLR MINIMUM alarm persists, turn the machine OFF, then
parameter. ON again.
Rev. B
W! AD CONVERTER 165
Reason Malfunction of analog/digital converter on the Protective Board.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary acquiring problem. 1. Press OVERRIDE to clear the alarm.
Rev. B
W! ANALOG HIVAR 166
Reason Protection Module unable to monitor the Temperature or Pressure Sensors.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary acquiring problem. 1. Press OVERRIDE. Wait a few seconds for
the alarm to be cleared. If the alarm
persists, discontinue the treatment, and turn
the machine OFF.
Rev. B
W! BLD CALIBRATION PHASE 167
Reason The calibration of the Optical Sensor for the Blood Leak Detector did not occur at
for Alarm the correct time.
Machine None.
Actions
Possible Suggested
Cause Action
1. The calibration of the Blood Leak Detector 1. Press OVERRIDE to clear the alarm. The
did not occur at the correct phase. This Blood Leak Detector will calibrate.
alarm usually occurs during a Fast Recovery
of the Dialysis process.
Rev. B
W! BLD FAST RECOVERY 168
Reason A Fast Recovery of the Dialysis process procedure has been performed by the
for Alarm operator and the EEPROM calibration value for the Blood Leak Detector has not
been set.
Machine None.
Actions
Possible Suggested
Cause Action
1. After a Fast Recovery of the Dialysis 1. Press OVERRIDE to clear the alarm. The
process, the value of the Blood Leak Blood Leak Detector will use a default
Detector has not been set. parameter.
Rev. B
W! BLD LED EXCESSIVE VALUE 169
Reason Excessive control voltage at the Blood Leak Detector transmitter Optical Sensor.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. An excessive control voltage at the Blood 1. Perform a Chemical Disinfect procedure to
Leak Detector transmitter Optical Sensor is clean the Sensor.
present, because of deposits on the
detector.
Rev. B
W! BLD RECEIVER EXCESSIVE VALUE 170
Reason An excessively high value is present at the receiver of the Optical Sensor, resulting
for Alarm in loss of Blood Leak Detector sensitivity.
Machine None.
Actions
Possible Suggested
Cause Action
1. An excessively high value is present at the 1. Press OVERRIDE to clear the alarm.
receiver of the Optical Sensor, due to Perform a Chemical Disinfect procedure to
deposits on the detector. clean the Sensor.
Rev. B
W! STILL IN BYPASS 171
Reason The machine has been in PATIENT CONNECT for more than 7 minutes or in the
for Alarm WASHBACK phase for more than 8 minutes.
Machine None.
Actions
Note
This message remains on the Touch Screen for a few seconds and then disappears automatically.
Possible Suggested
Cause Action
1. The machine remained in PATIENT 1. Proceed with DIALYSIS.
CONNECT for too long.
2. The machine remained in WASHBACK for 2. Press OVERRIDE or continue the treatment
too long. by pressing the DIALYSIS Action key.
Rev. B
W! DAC EXCURSION 172
Reason Protection Module unable to monitor Temperature or Pressure Sensors.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary acquiring problem. 1. Press OVERRIDE to clear the alarm.
Rev. B
W! E2PROM CRC 173
Reason The control memory CRC test performed by the Protection System for the correct
for Alarm number related to the calibration data has failed. The calibration data has been
lost and standard defaults are used.
Machine None.
Actions
Possible Suggested
Cause Action
1. The calibration parameters of the EEPROM 1. Turn the machine OFF and then ON again.
have been lost. Retry dialysis preparation.
Rev. B
W! RAM ERROR 175
Reason Error in reading Protection Module memory.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Protection Slave Board memory problem. 1. Turn the machine OFF and then ON again.
Retry Dialysate preparation.
Rev. B
W! PA AUTOCALIBRATION FAILED 176
Reason Acid/Acetate Pump Autocalibration by the Protection System has failed.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Concentrates were changed during the 1. Press OVERRIDE to clear the alarm. Wait a
Autocalibration procedure or the machine few seconds for the machine to stabilize,
has run out of concentrates. verify the correct Acid/Acetate
Concentrates are being used, and then
repeat the PA Autocalibration. If needed,
turn the machine OFF and then ON again
and repeat the PA Autocalibration.
2. Conductivity is not stable during the PA 2. Verify the Acid/Acetate Connector is
Autocalibration procedure. inserted well to the proper Concentrate
Wand. When the Acid/Acetate conductivity
is stable, repeat the PA Autocalibration. If
needed turn the machine OFF and then ON
again and repeat the PA Autocalibration.
3. Power failure during PA Autocalibration. 3. Turn the machine OFF and then ON again
and repeat the PA Autocalibration.
Rev. B
W! PB AUTOCALIBRATION FAILED 177
Reason Bicarbonate Pump Autocalibration by the Protection System has failed. (This alarm
for Alarm will only occur when Liquid Bicarbonate is used.)
Machine None.
Actions
Possible Suggested
Cause Action
1. Concentrates were changed during the 1. Press OVERRIDE to clear the alarm. Wait a
Autocalibration or the machine has run out few seconds for the machine to stabilize,
of concentrates. verify the correct Bicarbonate Concentrate
is being used, and then repeat the PB
Autocalibration. If needed turn the machine
OFF and then ON again, and repeat the PB
Autocalibration.
2. Conductivity is not stable during PB 2. Verify the Bicarbonate Connector is inserted
Autocalibration. well to the proper Concentrate Wand.
When the Bicarbonate conductivity is stable,
repeat the PB Autocalibration. If needed,
turn the machine OFF and then ON again
and repeat the PB Autocalibration.
3. Power failure during PB Autocalibration. 3. Turn the machine OFF and then ON again
and repeat the PB Autocalibration.
Rev. B
W! PI PRESSURE SENSOR 178
Reason A large pressure spike or a large rapid change were detected from the Pi Pressure
for Alarm Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
cleared.
Rev. B
W! PO PRESSURE SENSOR 179
Reason A large pressure spike or a large rapid change were detected from the Po Pressure
for Alarm Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
cleared.
Rev. B
W! PUF AUTOCALIBRATION FAILED 180
Reason Ultrafiltration Pump Autocalibration by the Protection System has failed.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The Ultrafiltration Pump has failed the PUF 1. Return to IDLE view, restart Dialysate
Autocalibration. preparation and repeat the PUF
Autocalibration.
2. Power failure during the PUF 2. Turn the machine OFF and then ON again
Autocalibration. and repeat the PUF Autocalibration.
Rev. B
W! PV PRESSURE SENSOR 181
Reason A large pressure spike or a large rapid pressure change was detected by the
for Alarm Venous Pressure Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary problem. 1. Press OVERRIDE. Wait a few seconds for the
alarm to be cleared.
Rev. B
W! UNRECOGNIZED SOFTWARE EXEC 182
Reason Execution error in program management of the Protection Module.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The Protection module detects an error in 1. Press OVERRIDE to clear the alarm.
execution of the software.
Rev. B
W! T1 TEST FAILED 183
Reason Failure of one of the T1 tests which does not stop the machine (see Section 5.B -
for Alarm Test Procedures, in this manual).
Machine None.
Actions
Possible Suggested
Cause Action
1. A T1 test related to: Temperature, 1. Turn the machine OFF, then back ON, and
Acid/Acetate or Bicarbonate Conductivity, restart Dialysis preparation to recheck the
or Blood Leak Detector failed during failed T1 test.
preparation.
2. The T1 test failed following turning the 2. It is NOT advisable to continue treatment. It
machine OFF, then back ON and restarting is the operators responsibility to carefully
Dialysis preparation. check the parameters involved in the failed
test if the decision is made to continue
treatment despite the test failure.
Rev. B
W! TEMPERATURE SENSOR 184
Reason A large temperature spike or a large rapid temperature change was detected by
for Alarm the TPS Temperature Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
alarm to be cleared.
Rev. B
W! UNKNOWN MESSAGE TYPE 185
Reason The Protection Module does not recognize the data sent.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
alarm to be cleared. If the alarm persists,
discontinue treatment, turn the machine OFF
and then back ON.
Rev. B
W! VOLTAGES INCORRECT 187
Reason The Protection Module detects a difference between the reference values and the
for Alarm supply voltages.
Machine None before Blood detection (patient not connected).

Actions In DIALYSIS: Alarm 160 occurs causing a GENERAL SAFE STATE.
WARNING
After patient connection this signal becomes #160, a Class P signal (see Class P alarms
section), which causes a GENERAL SAFE STATE and consequently stops the machine.
Possible Suggested
Cause Action
1. Power supply failure during preparation. 1. If the alarm persists until the end of the
preparation, do not proceed into DIALYSIS.
Call for Service.
Rev. B
W! WAIT TO CONTINUE 188
Reason Failure of a machine control test (T1 test) with a request for the operator to confirm
for Alarm if normal operation is to be continued despite T1 test failure (see Section 5.B - Test
procedures, in this manual).
Machine None.
Actions
Possible Suggested
Cause Action
1. T1 test failed. 1. Press OVERRIDE then CONFIRM to
proceed despite failure of T1 test.
WARNING
It is not advisable to continue treatment, but to notify Service as to which test failed. It is
the operators responsibility to carefully monitor the parameters involved in the failed test if
the decision is made to continue treatment despite the test failure.
Rev. B
W! STILL IN MINIMUM UF 189
Reason The machine has been in WLR MINIMUM for longer than 4 minutes.
for Alarm
Machine None.
Actions
Note
It is displayed every 4 minutes if the condition remains.
Possible Suggested
Cause Action
1. WLR MINIMUM Action key selected for 1. Deselect the WLR MINIMUM Action key to
longer than 4 minutes. reset the Ultrafiltration Rate to its set value.
The TOT WEIGHT L or UFR may need to be
adjusted to avoid Fluid Removal alarms.
2. An alarm condition sets WLR MINIMUM for 2. Correct the alarm condition to continue the
longer than 4 minutes. treatment.
Rev. B
TIME OUT PROC 190
Reason Service processes are stopped due to a time out.

for Alarm
Machine In ADR:
Actions Machine stops and goes to the RESTART phase.
Possible Suggested
Cause Action
1. An alarm has occurred that stopped the 1. Press the RESTART key after correcting the
procedure. alarm condition.
Rev. B
W! T1TESTS DISABLED 203
Reason T1 Test has been hardware disabled.

for Alarm
Machine The T1 Test will not be executed.

Actions
Note
This message remains on the Touch Screen for 5 seconds and then disappears automatically. It is
displayed every 5 minutes for all the dialysis treatment, starting from the selection of the
Dialysate Type until the end of the FINAL RINSE process.
WARNING
If the W! T1Tests Disabled #203 alarm appears, the machine must not be used for a patient
treatment. A Service Technician must re-enable the T1 Tests before using the machine for a
patient treatment.
Possible Suggested
Cause Action
1. The machine is being serviced and the T1 1. Press OVERRIDE to use the machine in
test has been temporarily disabled. vitro for service testing. A Service
Technician must re-enable the T1 Test
before using the machine for a patient
treatment.
Rev. B
W! LOW ART FLOW FOR TOO LONG 204
Reason Operator has set the Blood Pump to a value less than 50 ml/min for more than 4
for Alarm minutes.
Machine None.
Actions
Note
This message remains on the Touch Screen for a few seconds and then disappears automatically. It
is displayed every 4 minutes if the condition remains.
Possible Suggested
Cause Action
1. Blood Pump speed is less than 50 ml/min 1. Press OVERRIDE to clear the alarm.
for more than 4 minutes. Increase Blood Pump speed to more than
50 ml/min.
Rev. B
W! VENOUS LINE NOT FITTED 205
Reason The venous line has been incorrectly inserted in the Venous Line Clamp or inside
for Alarm the Air Bubble Detector housing.
Machine None. If an ! AIR & FOAM DETECTOR #4 alarm occurs when the venous
Actions line is not correctly placed in the Air Bubble Detector, it is not possible to
clear the alarm. When the RESUME key is pressed the Blood Pump doesnt
start and the Venous Line Clamp closes.
Possible Suggested
Cause Action
1. Venous line is not inserted correctly into the 1. Remove and correctly re-insert the venous
Venous Line Clamp. line into the Venous Line Clamp.
2. Venous line is not inserted correctly into the 2. Check the venous line position.
Air Bubble Detector housing.
Rev. B
OUTPUT OVERPRESSURE 206
Reason The Hydraulic Module Drain Pressure Switch (SWP1) is sensing HIGH pressure in
for Alarm the drain.
Machine The machine goes into Bypass and all Hydraulic Module Pumps are
Actions stopped, including the Ultrafiltration Pump.
Possible Suggested
Cause Action
1. Obstruction or kinking in the drain hose. 1. Verify the drain hose is not kinked or
obstructed in any way.
Rev. B
! S/N MIN PRESSURE DATA ERROR 208
for Alarm in the Main Board, for the SN P parameter.
Machine None.
Actions
Possible Suggested
Cause Action
the Main Board, for the SN P parameter. the alarm persists, restart the machine.
Rev. B
! S/N MAX PRESSURE DATA ERROR 209
for Alarm in the Main Board, for the SN P parameter.
Machine None.
Actions
Possible Suggested
Cause Action
the Main Board, for the SN P parameter. the alarm persists, restart the machine.
Rev. B
! CONDUCTIVITY PROFILE 210
Reason CURVE: The Conductivity Profile has caused a Protection Module data error.
for Alarm
TIMING: The Conductivity Profile timing has caused a Protection Module data
error.
SET VAL: The Conductivity Curve scanning set value has caused a Protection
Module data error.
Machine Machine goes into Bypass.

Actions
Disables Conductivity Profiling.
Note
is pressed.
Possible Suggested
Cause Action
1. The Protection Module detected an 1. Press OVERRIDE to clear the alarm.
incoherent condition in the Conductivity Before starting the following dialysis
Profiling execution. treatments, check and if necessary re-set the
profiling curves in Config/PROFILE.
Rev. B
! WEIGHT LOSS RATE PROFILE 212
Reason CURVE:
for Alarm The Ultrafiltration Profile has caused a Protection Module data error.
TIMING:
The Ultrafiltration Profile timing has caused a Protection Module data error.
SET VAL:
The Ultrafiltration Curve scanning set value has caused a Protection Module data
error.
Machine Ultrafiltration is reduced to the minimum.

Actions
Ultrafiltration Rate profiling is disabled.
Note
is pressed.
Possible Suggested
Cause Action
1. The Protection Module detected an 1. Press OVERRIDE to clear the alarm.
incongruent condition in the UF Profiling Before starting the following dialysis
execution. treatments, check and if necessary re-set the
profiling curves in Config/PROFILE.
Rev. B
BAD BLOOD LINE POSITION 219
Reason The machine detects an incorrect configuration of the Cartridge Blood Set during
for Alarm the Autoemptying Procedure.

Actions
Possible Suggested
Cause Action
1. The operator has clamped one of the lines 1. Verify that clamps are open on the Cartridge
on the Cartridge Blood Set. Blood Set.
2. The Cartridge Blood Set is not correctly 2. Verify the Cartridge Blood Set is correctly
configured for the Autoemptying Procedure. configured for the current phase of the
machine.
Rev. B
W! U.F. CALCULATION NOT RELIABLE 220
Reason The ! UF RATE ERROR: VESSEL #145 alarm has occurred too many times during
for Alarm DIALYSIS.
Machine None.
Actions
Possible Suggested
Cause Action
1. The ! UF RATE ERROR: Vessel alarm has 1. Press OVERRIDE to clear the alarm. The
occurred too many times during DIALYSIS. Fluid Removed data displayed may not be
accurate. Disconnect the patient. Refer to
alarm number 145 for further
troubleshooting information.
2. The Ultrafiltration Pump (PUF) 2. Perform PUF Autocalibration. See the
Autocalibration is required. directions for this procedure in Section 5.A -
Special Procedures.
Rev. B
ULTRAFILTER : TMP TOO HIGH 237
Reason Transmembrane Pressure has reached 90% of the maximum value set by the
for Alarm operator.
Machine In DIALYSIS: None.

Actions
Possible Suggested
Cause Action
1. The ultrafilter is approaching its expected 1. Press OVERRIDE to clear the alarm. The
end of life. ultrafilter needs to be replaced.
2. The operator set a value lower than the 2. Press OVERRIDE to clear the alarm. From
correct ULTRAF PRES parameter. IDLE view, on Config menu, verify the
correct value for the ULTRAF PRES
parameter.
Rev. B
! DIALYSIS TIME DATA ERROR 239
for Alarm in the Main Board, for the DIALYSIS TIME parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In Set Mode, restore the parameter to the
the Main Board, for the DIALYSIS TIME the machine.
parameter.
Rev. B
! TOT WEIGHT L DATA ERROR 240
for Alarm in the Main Board, for the TOT WEIGHT L parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In Set Mode, restore the parameter to the
the Main Board, for the TOT WEIGHT L the machine.
parameter.
Rev. B
DIASCAN INITIAL CALIBRATION FAILED 244
Reason Initial DIASCAN Autocalibration has failed.

for Alarm
Machine In DIALYSIS: None.

Actions DIASCAN Monitoring System is disabled.
Possible Suggested
Cause Action
1. An conductivity alarm or user intervention 1. During Autocalibration avoid alarms and
caused Autocalibration to fail. modifications to Dialysate conductivity and
flow rate in SET. The DIASCAN Monitoring
System is not available for the current
treatment.
2. The Autocalibration was out of range. The 2. Check if DIASCAN performs two auto-
DIASCAN conductivity measuring system is calibrations during the next treatment. The
not able to measure the correct DIASCAN Monitoring System is not
conductivity. available for the current treatment.
Rev. B
DIASCAN: INCORRECT MEASUREMENT 246
Reason A DIASCAN measurement could not be completed.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. An alarm or user intervention cancelled the 1. Avoid user interventions or conductivity
Diascan measurement. alarms during Diascan measurement.
2. The Diascan conductivity measuring system 2. Switch off the DIASCAN Monitoring System
is not properly working. in the Kt/V view.
Rev. B
DIASCAN: LIMIT LOW CLEARANCE 249
Reason The last measured value of the Clearance is lower than the fixed threshold.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The blood flow rate was changed. 1. Let the blood flow rate stabilize before
performing other procedures to clear the
alarm.
2. The Dialyser is clotting. 2. Determine reason for clotting and replace
the dialyser.
3. Problem with patients access or needle 3. Check patients access for correct needle
placement. The level of recirculation is placement.
increased.
4. Clearance threshold incorrect for this 4. Change the clearance threshold alarm level.
patient.
Rev. B
W! SET VALUE OUT OF RANGE 250
Reason The Protection System has detected a control set-value that is out of range.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The Protection System has detected a 1. Press OVERRIDE to clear the alarm.
control set-value that is out of range.
Rev. B
! DIASCAN MEASUREMENT FAILED : 251
Reason The Protection System has detected a violation of a DIASCAN safety criterion.
for Alarm 1. SET VALUE: Conductivity Step amplitude too high or too low.
2. Duration: Conductivity Step duration too long.
3. Frequen: Too many repetitions of the Conductivity Step.
Machine Machine goes into Bypass.

Actions
Note
is pressed.
Possible Suggested
Cause Action
1. The DIASCAN conductivity measuring 1. Press OVERRIDE to clear the alarm.
system has failed. DIASCAN is not reliable for the current
treatment. Switch off the DIASCAN
Monitoring System in the kT/V view.
Rev. B
W! PDR PRESSURE SENSOR ERROR 252
Reason A large pressure spike or a large rapid change in pressure was detected by the
for Alarm Drain Pressure Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
cleared.
Rev. B
BPM NOT CONNECTED 255
Reason The BPM is disconnected inside the machine.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The machine does not detect the BPM. 1. Press OVERRIDE to clear the alarm. During
DIALYSIS the BPM is not available. From
IDLE, turn the machine OFF then back ON
again and retry a measurement.
Rev. B
! DIASCAN FREQ. DATA ERROR 257
for Alarm in the Main Board, for the INTERMEASUREM parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In the Config/PROFILE/kT/V view, in SET
double image of the Protection System in Mode, restore the INTERMEASUREM
the Main Board, for the INTERMEASUREM parameter to the correct value. If the alarm
parameter. persists, restart the machine.
Rev. B
BLOOD MODULE<->MASTER DISK MISMATCH 259
Reason An incongruent condition has been detected between the Blood board
for Alarm configuration and the dialysis mode during a Fast Recovery of the Dialysis process.
Machine The dialysis process is not available.

Actions
Possible Suggested
Cause Action
1. During a Fast Recovery of the Dialysis 1. The Fast Recovery of the Dialysis process is
process the machine detected an not available, discontinue the treatment.
incongruent condition between the Blood Perform a RINSE to reset the alarm.
Board configuration and the Dialysis mode.
Rev. B
! BICART COND DATA ERROR 263
for Alarm in the Main Board, for the BICART COND parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. From Home view, in SET Mode, restore the
double image of the Protection System in parameter to the correct value. If the alarm
the Main Board, for the BICART COND persists, turn the machine OFF then back
parameter. ON again.
Rev. B
W! AIR & FOAM DETECTOR 264
Reason During Dialysate preparation, the Patient Sensor has detected blood in the venous
for Alarm line and the Air Bubble Detector has detected air in the venous line.

Actions
WARNING
OVERRIDE has no effect if the venous line is not inserted into the Venous Line Clamp (in
which case the alarm number 205: W! Venous Line Not Fitted appears).
Note
If the alarm is displayed only for a few seconds before the machine detects blood, ignore it. If the
alarm persists, refer to the troubleshooting procedure described below.
Possible Suggested
Cause Action
1. Air in venous line or Patient Sensor dirty or 1. Stop Dialysate preparation and return to
wet. the IDLE view. Remove the venous line
from the Air Bubble Detector and carefully
clean the Patient Sensor and the surface of
the Air Bubble Detector around the Patient
Sensor using a soft cloth. Carefully clean
the venous line using a soft cloth. Reinsert
the venous line in the Air Bubble Detector
and restart the Dialysate preparation.
Rev. B
BT2 MALFUNCTIONING 268
Reason LD2 Level Sensor malfunctioning. It appears only if a certain sequence of ! UF

for Alarm Mass Balance alarms (code number 144) occur.
Machine None. This alarm is only triggered during treatment. (Patient connection
Actions forward).
Possible Suggested
Cause Action
1. Dialysate Connectors are in the wrong 1. Verify the Dialysate Connectors are well
position. connected in the correct position and that
there are no air leaks.
Rev. B
DIASCAN: MEASUREM. IMPOSSIBLE (SET) 269
Reason The set-value for blood or dialysate flow rate has been changed during the
for Alarm measurement.
Machine None.
Actions
Possible Suggested
Cause Action
1. The blood or dialysate flow rate was 1. Press OVERRIDE to clear the alarm. A
changed during the measurement. DIASCAN measurement will not be
obtained at this interval. Avoid changing
blood or dialysate flow rates during
DIASCAN readings.
Rev. B
DIASCAN: MEAS. IMPOSSIBLE (ALARM) 270
Reason During the measurement, an alarm occurred and the machine went into Bypass.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Machine went into Bypass due to an alarm, 1. Press OVERRIDE to clear the alarm. A
or the operator put the machine into DIASCAN measurement will not be
Bypass. obtained at this interval. Avoid placing the
machine in BYPASS during DIASCAN
readings.
Rev. B
CENTR. ACID CONNECTOR POSITION 271
Reason The Central Acid Inlet Connector is not in the correct position for the current
for Alarm operating phase of the machine.
Machine In ADR:
Actions The machine stops and waits for the Connector to be correctly positioned.
In DIALYSIS:
The machine stops during the preparation phase. The machine goes into
Bypass during the treatment phase.
Possible Suggested
Cause Action
1. The Central Acid Inlet Connector is not in 1. Verify the correct configuration of the
the correct position for the current machine.
operating phase of the machine.
Note
If the machine has stopped during an ADR procedure when the alarm occurs, the SETUP Action
key is not available. Perform a complete ADR procedure in order to have the SETUP Action key
displayed in the IDLE view.
Rev. B
CENTR. BICARB CONNECTOR POSITION 272
Reason The Central Bicarbonate Inlet Connector is in the incorrect position required for
for Alarm the current operating phase of the machine.
Machine In ADR:
Actions The machine stops and waits for the Connector to be correctly positioned.
In DIALYSIS:
The machine stops during the preparation phase. The machine goes into
Bypass during the treatment phase.
Possible Suggested
Cause Action
1. The Central Bicarbonate Inlet Connector is 1. Verify the correct configuration of the
not in the correct position required for the machine.
current operating phase of the machine.
Note
If the machine has stopped during an ADR procedure when the alarm occurs, the SETUP Action key
is not available. Perform a complete ADR procedure in order to have the SETUP Action key
displayed in the IDLE view.
Rev. B
W! PATIENT SENSOR SATURATION 273
Reason The Protection System detects the maximum allowed value for the Patient Sensor.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. The Patient Sensor is malfunctioning. 1. Service is required. Call for Service.
Rev. B
! CONTROL SYSTEM OUT OF ORDER 274
Reason The Control System is not able to communicate with the Protection System.
for Alarm

Actions
Note
The Audible alarm, which signals the #274 alarm condition, can not be silenced by pressing the
MUTE button.
Possible Suggested
Cause Action
1. The control system is no more working 1. Turn the machine OFF. See the Fast
correctly. Recovery of the Dialysis process procedure
in the Section 5.A - Special Procedures, in
this manual.
Rev. B
! AUTOEMPTYING DATA ERROR 277
for Alarm in the Main Board, for the AutoEmptying parameter.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected inside the 1. In Config, restore the parameter to the
the Main Board, for the AutoEmptying the machine.
parameter.
Rev. B
ERROR ON CALIBRATION TOOL 279
Reason The machine has detected a problem during the P2 Autocalibration.

for Alarm This alarm can occurr only during Service calibration.
Machine The machine does not proceed with the P2 Autocalibration.

Actions
Possible Suggested
Cause Action
1. The machine has detected a problem during 1. No troubleshooting is required, this alarm
the P2 Autocalibration. can occurr only in calibration environment.
Rev. B
WAIT FOR CONFIRMATION 283
Reason The machine is waiting for the operator to confirm an Autocalibration of the PA or
for Alarm PB Pump.
Machine The machine stops and waits for confirmation.

Actions
Possible Suggested
Cause Action
1. The machine is waiting for the operator to 1. Check for correct concentrates and press
confirm an Autocalibration of the PA or PB CONFIRM to proceed.
Pump.
Rev. B
! AUTOEMPTYING: MAX ACTIVATION TIME 294
Reason The maximum volume of blood has passed through the Blood Pump during the
for Alarm AutoEmptying procedure.

Actions
Venous Line Clamp closes.
Possible Suggested
Cause Action
1. The Patient Sensor detects blood during the 1. The Autoempting procedure is stopped after
Autoempting procedure. 400 ml. Press OVERRIDE then an additional
100 ml will be infused.
2. The venous line is not correctly positioned 2. Verify the position of the venous line in the
in the Patient Sensor. Patient Sensor.
3. The Patient Sensor is dirty. 3. Carefully clean the Patient Sensor, using a
soft cloth.
Rev. B
BLOOD CARD COMMUNICATION TIMEOUT 295
Reason There was a communication problem detected between the Blood Slave Board
for Alarm and the Main board.
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary data overload of the Blood Slave 1. Wait a few seconds for the alarm to clear.
Board. Too much information is going to the See the Fast Recovery of the Dialysis
Blood Slave Microprocessor at one time. process procedure in the Section 5.A -
Special Procedures.
Rev. B
BIOSLAVE CARD COMM. TIMEOUT 296
Reason There was a communication problem detected between the Bio Slave Board and
for Alarm the Main Board.
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary data overload of the Bio Slave 1. Wait a few seconds for the alarm to clear.
Board. Too much information is going to the See the Fast Recovery of the Dialysis process
Bio Slave Microprocessor at one time. procedure in the Section 5.A - Special
Procedures.
Rev. B
BIOSLAVE MSG TRANSFER ERROR 297
Reason The Main computer and the Bio Slave Board are not communicating.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
cleared.
2. If alarm does not clear and the machine 2. See the Fast Recovery of the Dialysis
stops functioning. process procedure in the Section 5.A -
Special Procedures.
Rev. B
BT1 MALFUNCTIONING 299
Reason LD1 Level Sensor Failure.

for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Dirty LD1 level detector. 1. Perform a RINSING or a Chemical
Disinfection to clean the sensor of deposits.
Rev. B
D1 OUT OF ORDER 300
Reason The D1 flowmeter does not respond to changes in the dialysate flow.
for Alarm
Machine None.
Actions
Possible Suggested
Cause Action
1. Debris has clogged the gears in the flow 1. Perform a DESCALING. If the flowmeter is
meter. completely blocked, ADR cannot start.
Rev. B
D2 OUT OF ORDER 301
Reason The D2 flowmeter does not respond to changes in the dialysate flow. Possible
for Alarm Mass Balance alarms may precede this alarm.
Machine None.
Actions
Possible Suggested
Cause Action
1. Debris has clogged the gears in the flow 1. Perform DESCALING. If the flowmeter is
meter. completely blocked, ADR cannot start.
Rev. B
! BYPASS WRONGLY EXTENDED 302
Reason The machine is in Bypass for more than 6 minutes, either automatically or the
for Alarm operator has selected BYPASS.
Machine None.
Actions In DIALYSIS: The alarm is active when the machine is in DIALYSIS mode
with blood detected in the venous line. The alarm will be displayed on the
Touch Screen 6 minutes after the machine is in BYPASS.
Possible Suggested
Cause Action
1. Bypass has been selected and not cleared 1. Take the machine out of Bypass by pressing
during the treatment. the BYPASS Action key.
2. The machine is stuck in bypass. 2. See the Fast Recovery of the Dialysis
process procedure in the Section 5.A -
Special Procedures.
Rev. B
HYDRAULIC CARD COMM. TIMEOUT 304
Reason There was a communication problem detected between the Hydraulic Slave Board
for Alarm and the Main Board.
Machine None.
Actions
Possible Suggested
Cause Action
1. Temporary data overload of the Hydraulic 1. Wait a few seconds for the alarm to clear.
Slave Board. Too much information is going See the Fast Recovery of the Dialysis
to the Hydraulic Slave Microprocessor at process procedure in the Section 5.A -
one time. Special Procedures.
Rev. B
! ART PRESSURE ALARM 305
Attribute 1. MINIMUM,
2. MAXIMUM,
3. UNDEFIN
Reason MINIMUM: The Arterial Pressure Sensor has measured a pressure value which is
for Alarm lower than the minimum range selected by the operator and displayed on the
Arterial Pressure Bar Graph.
MAXIMUM: The Arterial Pressure Sensor has measured a pressure value which is
higher than the maximum permitted range selected by the operator and displayed
on the Arterial Pressure Bar Graph.
UNDEFIN: Error in the arterial pressure acquisition.

Actions
Reduces the Ultrafiltration Rate to its minimum.
Note
The following message appears in the operator messages area:
Check blood line and patient's access.
Press Override to restart the Pump. If needed
select in SET the graph of the pressure
causing the alarm and press CONFIRM
Possible Suggested
Cause Action
1. The arterial pressure window needs to be 1. In SET Mode, select the Arterial Pressure
set. Bar Graph and press CONFIRM.
Press OVERRIDE to restart the Blood
Pump.
2. The arterial line may have become 2. Carefully check Cartridge connections and
disconnected from the patient. the patients access site.
Pump.
3. Arterial line is kinked, clamped or restricted. 3. Check the arterial line and the patients
arterial access for kinks, clamps or other
restrictions, i.e. clotted arterial needle, poor
flow from the patients arterial access.
Pump.
Consider slowly increasing the blood flow,
observing the arterial pressure, if this
Rev. B
4. Loss of diaphragm pressure between the 4. Perform a Diaphragm Neutral Position

Cartridge Blood Set and the arterial pressure Procedure, see the Section 5.A - Special
cone. Procedures.
Pump.
WARNING
Never press the OVERRIDE button, to clear the ! Art Pressure Alarm #305 alarm, if the
Rev. B
! ART PRESSURE LIMIT 306
Reason Arterial pressure is lower than the MIN ART PRESSURE value set by the operator in
for Alarm the Configuration menu.

Actions
Reduces the Ultrafiltration Rate to its minimum.
Possible Suggested
Cause Action
1. The arterial line may have become 1. Carefully check Cartridge connections and
disconnected from the patient. the patients access site.
Pump.
2. Blood Pump speed is too fast. 2. Consider decreasing the blood flow if this
Pump.
3. Arterial line is kinked, clamped or restricted. 3. Check the arterial line and the patients
arterial access for kinks, clamps or other
restrictions, i.e. clotted arterial needle, poor
flow from the patients arterial access.
Pump.
4. Arterial pressure decreased somewhat 4. Attention should be given to re-evaluating
during a treatment due to needle size, blood flow rate, anticoagulant
haemoconcentration and/or inadequate dosage.
heparinization of the patient, resulting in a Press OVERRIDE to restart the Blood
reduced pressure for a given needle at a Pump.
fixed blood flow rate.
WARNING
Never press the OVERRIDE button, to clear the ! Art Pressure Limit #306 alarm, if the
Rev. B
! ART PRESSURE DATA ERROR 307
Reason A data difference was detected for the ART P parameter inside the double image
for Alarm of the Protection System in the Main Board.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected for the ART 1. From Set Mode, restore the parameter to
P parameter inside the double image of the the correct value. If the alarm persists,
Protection System in the Main Board. restart the machine.
Rev. B
W! BLOOD IN THE VENOUS LINE 308
Reason The Patient Sensor detected blood in the venous line.

for Alarm

Actions
Note
If the Standard buzzer is installed on the machine, the Audible alarm, which signals the #308 alarm
condition, has a low pitch modulated tone.
Possible Suggested
Cause Action
1. The Patient Sensor detected blood in the 1. Verify that the venous line is appropriately
venous line. attached to the patients access. Press
2. The Patient Sensor is dirty or wet. 2. If the alarm occurs during Dialysate
preparation and the Blood Pump is running,
it is not possible to proceed. Switch the
machine OFF, remove the venous line from
the Air Bubble Detector and carefully clean
the Patient Sensor and the surface of the Air
Bubble Detector around the Patient Sensor
using a soft cloth. Reinsert the venous line in
the Air Bubble Detector and then switch the
machine ON.
If the alarm occurs during PRIME or
RECIRCULATION, the machine is forced to
the PATIENT CONNECT view. At the end of
the current dialysis treatment, before starting
a new dialysis session, clean the Patient
Sensor following the procedure described
above.
Note
In case of blood detected in the venous line during PRIME, also the #342 alarm occurs together with
the #308 alarm. Refer also to the #342 alarm description to exit from the alarm condition.
Rev. B
W! MASS BALANCE NOT RELIABLE 309
Reason The ! UF Mass Balance #144 alarm has occurred too many times during the
for Alarm dialysis treatment.
Machine After the ! UF Mass Balance #144 alarm recurs 10 times, this alarm is
Actions displayed. Each time thereafter this alarm will display along with the ! UF
Mass Balance #144 alarm.
Possible Suggested
Cause Action
1. The ! UF Mass Balance #144 alarm has 1. Determine the cause of the ! UF Mass
occurred 10 times or continues to display Balance alarm (#144) then press OVERRIDE
during a treatment. to continue. Refer to Alarm number 144 for
additional troubleshooting information.
WARNING
After the ! UF Mass Balance (#144) recurs 10 times, the TOTAL FLUID REMOVED
displayed on video is no more reliable. If an external scale is being used, refer to the
weight measured by the scale to check the value of the TOTAL FLUID REMOVED. If an
external scale is not being used, discontinue DIALYSIS.
Rev. B
! MAX BLOOD FLOW DATA ERROR 312
Reason A data difference was detected for the MAX BLOOD FLOW parameter inside the
for Alarm double image of the Protection System in the Main Board.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected for the MAX 1. From IDLE view, in Config, restore the
BLOOD FLOW parameter inside the double parameter to the correct value. If the alarm
image of the Protection System in the Main persists, restart the machine.
Board.
Rev. B
! PAUSE THERAPY DATA ERROR 313
Reason A data difference was detected for the PAUSE THERAPY parameter inside the
for Alarm double image of the Protection System in the Main Board.
Machine None.
Actions
Possible Suggested
Cause Action
1. A data difference was detected for the 1. From IDLE view, in Config, restore the
PAUSE THERAPY parameter inside the parameter to the correct value. If the alarm
double image of the Protection System in persists, restart the machine.
the Main Board.
Rev. B
W! ART PRESSURE SENSOR ERROR 317
Reason A large pressure spike or a large rapid change in pressure was detected by the
for Alarm Arterial Pressure Sensor.
Machine None.
Actions
Possible Suggested
Cause Action
alarm to clear.
Rev. B
W! BLOOD PUMP STOPPED BY ABD 318
Reason The Blood Pump has not been restarted for 30 seconds following an ! Air & Foam
for Alarm Detector #4 alarm.
Machine Blood Pump is off.

Actions
Possible Suggested
Cause Action
1. The Blood Pump has not been restarted for 1. Restart the Blood Pump by performing the
30 seconds following an ! Air & Foam procedure to clear the alarm (instructions are
Detector #4 alarm. found in the description for the ! Air & Foam
Detector #4 alarm, in this section).
Rev. B
W! WAIT FOR PRESSURE TEST EXECUTION 319
Reason The machine cannot proceed with the Arterial and Venous T1 Test because the
for Alarm pressures are not close to 0 mmHg.
Machine The machine will stop at this point and not proceed any further into the
Actions test.
Possible Suggested
Cause Action
1. If the Cartridge Blood Set is filled with saline, 1. Clamp the Cartridge saline line, arterial and
it is possible to have a pressure different venous lines. Open the arterial and venous
from 0 mmHg. access lines to the atmosphere. The
pressures displayed on the Touch Screen
should decrease toward 0 mmHg.
2. The Cartridge Blood Set was installed 2. The venous line must be inserted in the Air
incorrectly during the Venous/Arterial Bubble Detector and the door closed. The
Pressure Test during the T1 test. Blood Pump Cover must be closed.
Reposition the Cartridge Blood Set and
restart the T1 test.
3. Blood Pump Cover is open. 3. Close the Blood Pump Cover. Be sure the
Blood Pump Cover is securely latched.
4. The magnet is dirty. 4. Carefully clean the magnet located behind
the Blood Pump Cover, using a soft cloth
dipped in Ethyl Alcohol (90%) or in
Isopropyl Alcohol (70%).
Rev. B
>> GENERAL SYSTEM FAILURE <<

System Blocking XXX
Reason THIS IS A SPECIAL ALARM.

for Alarm Main Board blockage.
Machine GENERAL SAFE STATE.

Actions Touchscreen blocked.
Note
In the alarm name, "xxx" means the internal code related to the alarm condition.
Possible Suggested
Cause Action
1. Main Board internal error. 1. If this alarm occurs during ADR, IDLE,
SETUP and PRIME, switch the machine OFF
and then back ON.
2. Main Board internal error. 2. If this alarm occurs during DIALYSIS,
perform a Fast Recovery of the Dialysis
process. See the Fast Recovery of the
Dialysis process Procedure in Section 5.A
Special Procedures.
Rev. B
CENTRYNET: DUPLICATE STATION 321
Reason The station number entered into the machine is in use(duplicated) by another
for Alarm machine on the network.
Machine None to the patient system.

Actions Automatically resets when the error condition is corrected.
The CentryNet: Station ID Error alarm also appears.
Possible Suggested
Cause Action
1. The same STATION ID number has already 1. Check that the STATION ID on the machine
been assigned to another machine. matches the posted STATION ID in the
clinic. Verify the other stations. Change the
STATION ID for the machine that is
incorrect, correcting any duplication.
Note
This alarm is not functional if the CentryNet option is not installed, or when the CentryNet option is
turned OFF (CentryNet = NO).
Note
If the alarm persists, the CentryNet option must be switched OFF. The user is responsible for
manually collecting data until the cause of the alarm can be corrected.
Note
A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Duplicate
Station has cleared. If a treatment is in progress, the network controller will retain any data that it has
collected until the station comes back online.
Rev. B
CENTRYNET STATION OFFLINE 322
Reason The network controller has failed to successfully poll a particular station on the
for Alarm network (the machine did not receive a poll within the expected polling time).
Machine None to the patient system. Automatically resets when the error condition
Actions is corrected. START COLLECT/STOP COLLECT keys are not active. The
icon changes to indicate Off-Line.
Possible Suggested
Cause Action
1. A configuration setting is incorrect. 1. Verify all configuration items relating to
CentryNet.
2. The CentryNet Network Controller is not 2. Add the station to the network (see the
programmed for this station. Communication section) for instructions.
3. The Offline Timeout (polling timer) limit has 3. Polling timer limit may need changing to
been exceeded. accommodate the number of machines
and quantity of data being collected.
Note
Note
Note
A treatment cannot be started or ended on the Phoenix machine until the CentryNet Station Offline
error has cleared. If a treatment is in progress, the network controller will retain any data that it has
collected until the station comes back online.
Rev. B
CENTRYNET: INCOMPLETE DATA COLLECTION 323
Reason An attempt to end a treatment (STOP COLLECT) has been made before all records in
for Alarm the database have been collected by the network controller.
Machine None to the patient system. Automatically resets when error condition is
Actions corrected.
Possible Suggested
Cause Action
1. The treatment has ended in the normal 1. Wait a few minutes until data collection is
fashion (WASHBACK, DESCALE, FINAL complete. Verify all cable connections are
RINSE, etc.) and all data from that treatment intact; verify the network controller is
has not yet been collected by the Network collecting data.
Controller.
2. The STOP COLLECT Action key has been 2. Wait a few minutes until data collection is
pressed and all data from the current complete and then press STOP COLLECT
treatment has not yet been collected by the again.
Network Controller.
3. The network controller is polling another 3. Wait for the network controller to finish polling
machine. other machines.
4. CentryNet is unable to collect a number of 4. Switch the CentryNet option OFF and take
records for this treatment due to an internal records manually for that treatment. Turn
Phoenix problem. CentryNet back ON for the next treatment
and determine if the problem has corrected
itself.
5. The station is off-line; the STATION OFFLINE 5. Switch the CentryNet option OFF. Continue
alarm condition will eventually occur. using the machine without CentryNet. Refer to
the CentryNet Station Offline #322 alarm
message and troubleshooting advice.
Note
Note
Note
A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Incomplete
Data Collection error has cleared. If a treatment is in progress, the network controller will retain any
data that it has collected until the station comes back online.
Rev. B
CENTRYNET: STATION ID ERROR 325
Reason A poll has been received by Phoenix, but the network controller machine ID does not
for Alarm match the Phoenix machine ID for that station, or the machine has not been assigned
to that station (awaiting assignment).
Machine None to the patient system. Automatically resets when error condition is
Actions corrected.
Possible Suggested
Cause Action
1. A configuration setting is incorrect. 1. Verify all configuration items relating to
CentryNet.
2. A new STATION ID is currently being 2. No action necessary. Wait for
processed. communication process to be completed.
The alarm will self-clear.
3. Either the machine, or the CentryNet option, 3. No action necessary. Wait for
has just been turned on and communication communication process to be completed.
is being established The alarm will self-clear.
4. Two stations have the same STATION ID; 4. Check that the STATION ID on the alarming
the CentryNet: Duplicate Station (Alarm machine matches the posted STATION ID in
#321) message appears on screen. the clinic. Change the STATION ID for one
machine, correcting any duplication
5. STATION ID assignment has been lost at 5. Make sure the STATION ID matches the
CentryNet, or has changed. physical location in the clinic. If not in a
treatment, reboot the Phoenix to reinitialize
the STATION ID assignment.
Note
Note
If the alarm persists, the option must be switched OFF. The user is responsible for manually
collecting data until the cause of the alarm can be corrected.
Note
A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Station ID
Error has cleared. If a treatment is in progress, the network controller will retain any data that it has
collected until the station re-links with CentryNet.
Rev. B
WHF DOOR POSITIONING 326
Reason The Waste Handling Option Door is open during an operational phase that
for Alarm requires the WHO Door to be closed.
Machine The machine stops and waits for the WHO Door to be closed.
Actions
Possible Suggested
Cause Action
1. The Waste Handling Option Door is open 1. Verify that the Door is closed.
when it should be closed.
Rev. B
W! COMMUNICATION CRC ERROR 327
Reason The Protection test for the correct reading of the message sent by the Control
for Alarm System has failed. The message has been lost and the last correct message is used.
Machine None.
Actions
Possible Suggested
Cause Action
1. The Protective system detected an incorrect 1. Press OVERRIDE to clear the alarm. Confirm
message from the Control system. the data using the selection procedure.
Rev. B
W! STILL IN PAUSE THERAPY 329
Reason The operator has maintained the selection of PAUSE THERAPY for more than 5
for Alarm minutes (approx).
Machine None.
Actions
Note
Possible Suggested
Cause Action
1. The operator has maintained the selection 1. Press OVERRIDE to clear the alarm.
of PAUSE THERAPY for more than 5 Deselect PAUSE THERAPY to continue the
minutes. treatment.
Rev. B
END OF WASHBACK PROCEDURE 332
Reason The quantity of physiological saline solution that has passed through the dialyser is
for Alarm equal to the RINSEBACK VOLUME set by the operator.
Machine The Blood Pump stops.

Actions
Possible Suggested
Cause Action
1. The quantity of physiological saline solution 1. Press OVERRIDE to continue, or end the
that has passed through the dialyser is equal treatment. Consider changing in Config the
to the RINSEBACK VOLUME SET by the quantity of physiological solution for
operator. WASHBACK (RINSEBACK VOLUME
parameter).
Rev. B
TIMEOUT ERROR ON PROCESS SELECTION 333
Reason Failure of the communication between BOM and the machine.

for Alarm This alarm can occur only during the manufacturer tests.
Machine NONE. The alarm will be used only during the manufacturer tests.
Actions
Possible Suggested
Cause Action
1. Failure of the communication between 1. No troubleshooting is required, this alarm
BOM and the machine. can occur only during the manufacturer
tests.
Rev. B
TIMEOUT ERROR ON PROCESS CLOSING 335
Reason Internal communication error.

for Alarm
Machine The machine doesnt transfer data to the On Board Calibration

Actions environment.
Note
This alarm can occurr only during the machine Calibration procedures.
Possible Suggested
Cause Action
1. Internal communication error. 1. No troubleshooting is required, this alarm
can occur only during the machine
calibration procedures.
Rev. B
TOTAL HEPARIN INFUSED ERROR 338
Reason The Heparin Pump is malfunctioning or it is not delivering the correct amount of
for Alarm heparin.
Machine None.
Actions
Possible Suggested
Cause Action
1. The Heparin Pump is malfunctioning. 1. Verify the total amount of heparin delivered.
Verify that the machine has delivered the
correct initial bolus if required. Press
2. The Heparin Pump is still malfunctioning. 2. Deactivate the Heparin program to clear the
alarm.
Rev. B
END DIA - DIFF TIME REACHED 339
Reason This message signals the operator that the DIFFUSION TIME is complete. This
for Alarm alarm will occur only if DIFFUSION TIME has been selected as the treatment end
point for the END DIALYSIS parameter.
Machine None.
Actions
Note
Possible Suggested
Cause Action
1. DIFFUSION TIME is complete. 1. Disconnect patient.
2. Additional DIALYSIS TIME may be needed. 2. Increase the set DIALYSIS TIME to lengthen
the treatment.
Note
The alarm will self-clear if the DIALYSIS TIME parameter value is increased.
Note
If the DIALYSIS TIME is increased following the occurrence of this alarm, the DIFFUSION TIME
parameter will not be updated.
Rev. B
BLOOD PUMP DIRECTION 340
Reason During DIALYSIS, when all the machine safety systems are activated, the Blood
for Alarm Pump is not turning in the correct direction for the current machine operating
phase.

Actions
Possible Suggested
Cause Action
1. The blood pump is not turning in the correct 1. The > GENERAL SAFE STATE < 64 alarm will
direction due to an internal malfunction. occur. Refer to alarm number 64 for further
Rev. B
! BLOOD DETECTED DURING PRIME 342
Reason During PRIME, The Patient Sensor detected blood in the venous line.
for Alarm

Actions
Ultrafiltration Rate is set to zero.
Possible Suggested
Cause Action
1. The Patient Sensor is dirty or wet. 1. The machine is forced to the PATIENT
CONNECT view. At the end of the current
dialysis treatment, before starting a new
dialysis session, clean the Patient Sensor and
the surface of the Air Bubble Detector
around the Patient Sensor using a soft cloth.
Note
If blood is detected in the venous line during PRIME, the #308 alarm will also occur together with
the #342 alarm. Also refer to the #308 alarm description to exit from the alarm condition.
Rev. B
W! DRIFT ON FLOWMETERS 343
Reason The D1/D2 flowmeter test, performed during the dialysis preparation phase, has
for Alarm failed due to a drift of the flowmeters.
Machine None.
Actions
Note
Flow Balance alarm MAY occur during Tx
Recommend Descale at the end of Tx. for the
maximum amount of time, or perform acid
based chemical disinfect now.
Possible Suggested
Cause Action
1. There are deposits or debris inside the 1. Press OVERRIDE to clear the alarm. Stop
flowmeters of the machine. the dialysis preparation and return to IDLE
view. Perform a DESCALING or a Chemical
Disinfection to clean the flowmeters of
deposits, then restart the dialysis
preparation. If the problem persists, turn the
machine OFF and call for Service.
2. Test failed due to a problem on the 2. Press OVERRIDE to clear the alarm. Stop
flowmeter(s). the dialysis preparation and return to IDLE
view. Restart the dialysis preparation. If the
problem persists, turn the machine OFF and
call for Service.
Rev. B
S/N: VEN PRESSURE NOT CHANGING 351
Reason In Single Needle Mode, the venous pressure remains stable during the arterial
for Alarm cycle.

Actions
Note
OVERRIDE has no effect if the machine doesnt detect a variation in the venous pressure value.
Possible Suggested
Cause Action
1. The Blood lines are kinked, clamped or 1. Check the Blood lines and the patients
restricted. access for kinks, clamps or other
restrictions.
Press OVERRIDE to restart the Blood Pump
and clear the alarm.
2. Clotting is occurring in the Cartridge Blood 2. Verify that there is no clotting in the
Set. Cartridge Blood Set.
3. The patient is moving around. 3. Press OVERRIDE to restart the Blood Pump
4. Incorrect placement of the diaphragm 4. Perform a Diaphragm Neutral Position
between the Cartridge Blood Set and the Procedure (See Section 5.A Special
5. Arterial and/or venous lines are not in their 5. Press OVERRIDE to restart the Blood Pump
clamps. and clear the alarm. Place the line(s) in the
clamp(s).
Rev. B
S/N: VENOUS PRESSURE UNRELIABLE 352
Reason The S/N: Ven Pressure Not Changing #351 alarm has occurred 3 times during
for Alarm the dialysis treatment.
Machine None.
Actions
Note
This message remains on the Touch Screen for all the dialysis treatment until the EMPTYING
Action key confirmation.
Possible Suggested
Cause Action
1. The S/N: Ven Pressure Not Changing 1. Determine the cause of the alarm then
#351 alarm has occurred 3 times during the press OVERRIDE to continue. Refer to
dialysis treatment. Alarm number 351 for additional
Rev. B
NO POWER 353
Reason The AC supply voltage has been interrupted in a machine equipped with the
for Alarm BATTERY BACKUP KIT.
Machine In RINSE: None.

Actions In DISINFECTION and in DIALYSIS: the heater is turned off.
Possible Suggested
Cause Action
1. Interruption of the AC supply voltage in RINSE 1. Switch OFF the machine.
or DISINFECTION.
2. Interruption of the AC supply voltage in 2. Switch OFF the machine.
DIALYSIS, during the Dialysate Preparation
phase until Patient Connection.
3. Interruption of the AC supply voltage in 3. Perform WASHBACK to return blood to the
DIALYSIS, during the treatment phase. patient and then switch OFF the machine.
4. Interruption of the AC supply voltage in 4. Switch OFF the machine.
DIALYSIS, during EMPTYING or DESCALING.
Note
If the power failure lasts for less than 3 minutes, once the AC Power Supply returns:
- The No Power #353" alarm disappears;
- The interrupted process automatically restarts and no operator intervention is required.
Note
In Rinsing or Disinfection, if the No Power #353" alarm is displayed for more than 3 minutes, the
machine will be automatically switched OFF.
Rev. B
FORECAST DIAL. DOSE NOT MATCH PRESCRIP. 354
Reason The Forecast Kt/V (or Kt), estimated by the machine, is lower than the TARGET
for Alarm Kt/V THRESH Percentage. (The parameter TARGET Kt/V THRESH is SET in the IDLE
mode in the Config\kT/V view.)
Machine None.
Actions
Note
Check Clearance/Blood Flow R. consistency
Check Treat. Time/Prescription consistency
Enter SET Mode to modify the Target; then
Press OVERRIDE to cancel the message
Note
The FORECAST DIAL. DOSE NOT MATCH PRESCRIP.#354 alarm will occur only if the TARGET
Kt/V THRESH parameter is set to a value different from 0 and the TARGET KT or the TARGET KT/V
parameter value has been confirmed/entered.
Possible Suggested
Cause Action
1. The Dialyser is clotting. 1. Determine reason for clotting and replace the
dialyser. Press OVERRIDE to clear the alarm.
2. Problem with patients access or needle 2. Check patients access for correct needle
placement. The level of recirculation is placement. Consider decreasing the blood
increased. flow if this operation is not in disagreement
with the patient prescription. Press OVERRIDE
to clear the alarm.
3. Dialyser is not providing sufficient Clearance 3. Verify that the dialyser selected is adequate to
to meet Target Dose. deliver the Prescribed dialysis dose. Press
4. The blood flow rate is not consistent with the 4. Verify that the patient prescription is correct.
TARGET KT and/or the TARGET KT/V Consider increasing the blood flow rate if this
programmed. operation is not in disagreement with the
patient prescription. Press OVERRIDE to clear
the alarm.
5. Dialysate connectors are reversed (blue 5. Correctly connect the dialysate connectors.
dialysate connector is not connected to the Press OVERRIDE to clear the alarm.
inlet dialysate port of the dialyser).
6. The DIALYSIS TIME set is not consistent with 6. Verify that the patient prescription is correct.
the TARGET KT/V programmed. Consider increasing the DIALYSIS TIME if this
patient prescription. Press OVERRIDE to clear
the alarm.
Rev. B
7. The TARGET KT and/or the TARGET KT/V 7. Verify that the patient prescription is correct.
programmed is not consistent with the patient Consider changing the TARGET KT and/or the
prescription. TARGET KT/V value programmed or consider
setting a lower value for the TARGET Kt/V
THRESH parameter. Press OVERRIDE to clear
the alarm.
Rev. B
KT-KT/V TARGET ACHIEVED 355
Reason If DISTRIB VOLUME and DRY WEIGHT parameter values have not been
for Alarm confirmed:
The Depurated Vol is greater than or equal to the TARGET KT value.
If DISTRIB VOLUME and DRY WEIGHT parameter values have been confirmed:
The KT/V is greater than or equal to the TARGET KT/V value.
Machine None.
Actions
Note
In Config, the TARGET Kt/V Reached parameter can be configured to NO or YES. If set to NO, the
Kt-Kt/V Target Achieved alarm is turned off and will not appear. If set to YES, when the alarm
appears once, it can be reset by pressing the OVERRIDE button and then it does not appear again
during the same dialysis treatment. The Kt-Kt/V Target Achieved alarm will appear again during the
same dialysis treatment only after a modification of at least one of the following parameter values:
- TARGET KT
- TARGET KT/V
- DIALYSIS TIME
- DRY WEIGHT
- DISTRIB VOLUME.
Possible Suggested
Cause Action
1. The Depurated Vol is greater than or equal to 1. Press OVERRIDE to clear the alarm.
the fixed percentage of the TARGET KT value.
2. The KT/V is greater than or equal to the fixed 2. Press OVERRIDE to clear the alarm.
percentage of the TARGET KT/V value.
Rev. B
W! BLOOD SENSED IN VENOUS LINE 359
Reason The Patient Sensor detected blood in the venous line during priming of the blood
for Alarm side of the dialyser and the Blood Pump was running.

Actions
Note
When the alarm appears also the following superimposed window is displayed:
- Clean and dry venous line & pt. sensor slot
- Put venous line back in the patient sensor
- Press CONFIRM
Possible Suggested
Cause Action
1. The Patient Sensor detected blood in the 1. Verify that the venous line is appropriately
venous line. attached to the patients access. Press
CONFIRM to clear the alarm.
2. The Patient Sensor is dirty or wet. 2. Follow the instructions given in the
superimposed window: remove the venous
line from the Air Bubble Detector and
carefully clean the venous line, the Patient
Sensor and the surface of the Air Bubble
Detector around the Patient Sensor using a
soft cloth. Then reinsert the venous line in
the Air Bubble Detector. Verify that the No
blood detected Patient Sensor Icon is
displayed in the Icon Area on the Touch
Screen and then press CONFIRM to clear
the alarm.
Note
If the Patient Sensor continues to detect blood after performing the cleaning and drying procedure
described in the superimposed window, the W! Blood sensed in venous line #359 alarm message
will reoccur together with the superimposed window. The operator is allowed to remove the
venous line from the Air Bubble Detector to clean and dry the Patient Sensor and the venous line
for a maximum of three times.
Rev. B
9 SPECIFICATIONS
9. SECTION 9 - SPECIFICATIONS
9.1 General specifications
Name PHOENIXTM
Haemodialysis Equipment.
Equipment Classification
Class I, Applied Part Type B (EN 60601-1)
Class IIb (MDD 93/42/EEC)
Protection Class: IPX1 (drip-proof equipment)
Not suitable for use in the presence of flammable anesthetics, or anesthetic
mixtures with air or with oxygen or nitrous oxide.
Continuous operation.
Note
The Phoenix machine is classified as Class I APPLIED PART B device, according to the IEC
60601-1 international electrical safety standard. As a result the Phoenix machine is not
recommended for use in direct cardiac applications.
Version
The machine can be installed according to one of the following power supply
versions:
N Zone Power supply

1 Europe 220 V 50/60 Hz
2 Europe, South America 230 V 50/60 Hz
3 UK 240 V 50/60 Hz
4 North America, US 115 V 60 Hz
Dimensions
Parameter Dimension
Height 1440 mm (56.7 in)
1970 mm (77.4 in) with IV Pole
Width 610 mm (24.0 in) with Dialyser
holder in working position
Depth of base 710 mm (27.9 in)
930 mm (36.5 in) with Chemical
Container Shelf
Total floor surface covered by base 433100 mm (671.3 in)
567300 mm (879.3 in)
Dry weight 120 kg (264.5 lb)
Non-combustible plastic materials for external panels and electronic keyboard cover
(in compliance with CSA standard C22.2 no. 6 "self-extinguishing").
Rev. B
Ambient requirements and storage conditions

State Temperature Humidity
Operational +10C to +40C (50F to 104F) 30 to 85 % rh
Storage -20C to +70C (-4F to 158F) 10 to 95 % rh (non-condensing)
Atmospheric pressure range

State Pressure
Operational 700 to 1060 hPa
Storage 500 to 1060 hPa
WARNING
Storage under 0C (32F) is not recommended unless the hydraulic circuit has been
emptied (see Maintenance section of the Service Manual).
Electromagnetic Environment Requirements

The PHOENIX machine needs specials precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the
Appendix A, in this manual.
WARNING
The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic
Compatibility; thus it has an adequate degree of protection against electromagnetic
disturbances.
However, to prevent any problems, it is not recommended to use cellular phones
(hand-held) in the dialysis room or, at least, to keep a minimum distance of 10 m
(33 ft) from the equipment.
Refer to, and be compliant with, local standards and guidelines. (For additional
information about special precaution regarding EMC, refer to Appendix A in this
manual).
Automatic turn-off
Can only be enabled for rinsing and disinfection phases.
CE Marking
The PHOENIX machine has been developed to conform to the requirements of the
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
The CE marking by the manufacturer GAMBRO DASCO S.p.A. covers the equipment.
The compatibility of the PHOENIX machine with the other accessories and
disposables listed in this Operator Manual has been verified during product validation.
Rev. B
SECTION 9 - SPECIFICATIONS 9-3
Conformity with international rules

The PHOENIX machine has been developed to conform to the following electrical
safety standards:
IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT Part 1. General

VDE 0750-1 Requirements for Safety (Equivalent to EN 60601-1)
CEI 62/5
BS 5724-1
UL 2601-1
IEC 60601-2-16 MEDICAL ELECTRICAL EQUIPMENT Part 2. Particular
VDE 0750-206 requirements for safety of haemodialysis equipment.
CEI 62/98 (Equivalent to EN 60601-2-16)
BS 5724-2-16
IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT Part 1. General
Requirements for Safety.
2. Collateral standard: Electromagnetic compatibility -
Requirements and tests (Equivalent to EN 60601-1-2)
Requirements for Safety.
1. Collateral standard: Safety Requirements for Medical
Electrical System. (Equivalent to EN 60601-1-1)
Requirements for Safety
1. Collateral standard: Programmable electrical medical
systems (Equivalent to EN 60601-1-4)
CSA C22-2 N 601-1-M90 MEDICAL ELECTRICAL EQUIPMENT. General
CAN/CSA C22-2N601-2-16-92 MEDICAL ELECTRICAL EQUIPMENT Part 2. Particular
requirements for safety of haemodialysis equipment.
UL 2601-1 MEDICAL ELECTRICAL EQUIPMENT. General
Independent internationally recognized experts have rigorously checked conformity

with these standards.
Leakage current and dielectric strength

Earth Leakage Current: <300uA as required by the UL 2601-1 Standard (typically
between 80 and 130 uA) (115V); <300uA as required by the UL 2601-1 Standard
(typically between 170 and 220 uA) (230V).
Patient Leakage Current (normal condition): max 5uA (115V), max 10 uA (230/240V).
Dielectric strength: verified in compliance with clause 20 of IEC 601-1 (UL 2601-1).
Rev. B
Note
The above measurements are applicable when all standard and optional accessories
designed for the PHOENIX are connected.
WARNING
Possible hazards may arise from equipment (other than the accessories listed
below) being connected to machine, which may cause the permitted leakage
current to be exceeded.
WARNING
The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each
SYSTEM component be individually connected to the main power.
It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET-
OUTLETS.
However, if using multiple portable socket-outlets, they must comply with the IEC
60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR.
Electrical Power Supply two standard versions:

N Volts % Range Hertz Amps
1 230/240 10 50/60 10 Note 1
2 115 10 60 16 or 12 (without heat disinfection)
Note 1
It is possible to operate the machine with a 220 or 240 volt power supply. However,
selection of voltage requires an internal service configuration.
Note
Both versions are fitted with a three-pin plug which includes a Ground.
WARNING
Wait at least 5 seconds after switching OFF the machine before turning it ON
again.
Power failure
If there is a power failure, an audible alarm is triggered and the yellow lamp is
illuminated. The values programmed and the modes set remain in the machines
memory for 4 minutes.
Rev. B
Shipping List
The machine packaging contains a shipping list with the following components:
Water Inlet Hose and Drain Hose

Connection Set
Sampling Connector
Dialysate Connectors and Lines
Intravenous Pole (maximum load: 6 Kg or 13.2 lb)
Note
The telescopic pin adjustment must be done without bags on the hooks
Concentrate/Disinfectant Wands
Chemical Container Shelf (maximum load: 16 Kg or 35.3 lb)
WARNING
Do not stand on Chemical Container Shelf.
pH Probe Assembly
Blood Pump Crank
BPM Cuff
Single Needle Holder
Operators Manual
Installation Checklist
Accessories
BPM (Blood Pressure Monitoring System)
Central Concentrate Supply Kit
DIASCAN Kit
Single Needle Kit
CentryNet serial interface board (RS 485)
CWP Adapter Kit
Clean Dialysate
Remote Alarm
Battery Backup Kit
Note
Refer to your local representative to verify if your machine is already equipped with the
BATTERY BACKUP Kit.
Rev. B
Interface connectors
See Fig 9.0.
The machine is supplied with a standard 10 Base T Ethernet connection.
The Computer Connection Accessories may be used to connect the machine to a
Personal Computer to interface with the Communication System (see Section 7
Communication System in this manual).
The BPM port is the pneumatic connection used for the BPM option (see Section 5.C
- Blood Pressure Monitoring System in this manual).
The other connectors are currently not used.
WARNING
The PHOENIX machine is provided with ports for connecting it with an external
personal computer or a communication network. All external equipments
connected to the PHOENIX machine must be compliant with IEC 60950.
Wheels and portability

The PHOENIX system is maneuvered by 4 double wheels and one brake which is at
the front of the concentrate container shelf. The brake is foot-operated: to brake, press
the left side of the pedal completely down; to release the brake, press the right side of
the pedal completely down. To avoid jolting, move the machine carefully using the
rear handle.
Note
A two-color plate status indicator, fitted behind the brake pedal, indicates whether the
brake is ON or OFF. When red is visible, the brake is ON, when green is visible, the brake
is released.
WARNING
Before moving the machine, check that the brake is released and remove infusion
bags or any other weights or hanging objects from the IV pole or from the
concentrate container shelf.
Software revision
This manual revision is related to the software revision root 3.36.
Rev. B
Hour Meter
(Depending on the
machine version, it may
be present or not in the
Interface Connectors
Panel)
Computer
Connection
Remote
alarm
External water
valve
(not used)
Fig 9.0 Interface Connectors
Rev. B
9.2 Hydraulic section
9.2.1 Water supply
Incoming water
Water treated for the haemodialysis process should be obtained using purification
processes. Examples include: reverse osmosis, deionization, ion exchange or any
other system approved by the person responsible for the dialysis facility.
Water Quality Requirements.

Refer to the local standards or to the AAMI RD62 "Water treatment equipment for
hemodialysis applications" standard.
Main requirements
Incoming water Required value
Pressure 100 to 600 kPa (14.5 to 87.0 psig)
Flow 1.1 l/min
Temperature 10C to 32.2 C (50F to 90 F)
Filtration (by internal filter) 250 m RMS
Drain
Maximum height above floor level: 1 m (39.4 in)
Maximum distance to the drain 3 m (118.1 in)
Drain flow : 1.1 l/min max.
Temperature: +95 C max (203 F max)
Make the connection, as described in applicable local and international standards,

with an external pressure connector to avoid back flow. Mantain an air clearance
between the drain connector of the machine and the drain itself.
Color Code Concentrate Connectors

Front:
Bicarbonate Connector : Blue
Acetate/Acid Connector : White/Red
Disinfectant Connector : Yellow
Rear:
Two permanent lines :Yellow/No-Coloured connected to disinfectant
containers on the back of the machine.
Rev. B
9.2.2 Dialysate
WARNING
It is recommended to use concentrates which conform to the requirements of the
local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or
of the European Pharmaceutical standards.
The control of alarm thresholds and dialysate conductivity precision is of major
medical importance in ensuring a safe dialysis treatment.
WARNING
verified by clinical laboratory results, for each dialysate concentrate used for
dialysis treatment.
Note
For the dialysate concentrates listed in this manual, some graphs and tables are given as
examples of the correspondence between dialysate conductivity and dialysate solute
content of those particular dialysate concentrates.
WARNING
Attention must be given to the safety hazards related to incorrect choice of
dialysate concentrates.
Note
Concentrate is drawn into the machine by a peristaltic pump.
The concentrate supply pressure range at which the machine operates is 0 to 1 bar (0 to
14.5 psi).
The concentrate temperature must be between 5 C (41F) and 30 C (86F).
Total conductivity of the dialysate

Permitted values 13 - 17 mS/cm
Average accuracy 1.5% of the selected value
Alarms 5% of the selected value
Protection system type Monitoring of the dialysate electrical
conductivity
Note
When the Final Conductivity value set is changed, the Protection System verifies the
congruency of the variation during the transition period.
Rev. B
Conductivity of the Bicarbonate Solution

Both BiCart (sodium bicarbonate cartridge - see specific instruction sheet) and a
solution of sodium bicarbonate can be used with the PHOENIX machine. Two
different types of solution of sodium bicarbonate, namely BIC 8.4% and BIC 6.6%,
will be described in the following tables.
Note
If the bicarbonate concentrate, selected for a BIC 8.4% dialysis treatment contains only
NaHCO3 (sodium bicarbonate), the NaHCO3 concentration must be at least of 70.00 g/l
so that the machine reaches a correct value of dialysate conductivity.
Type 1: BIC 8.4%
Bicarbonate Concentrate
Nominal composition of 8.4% Bicarbonate Concentrate type:
Ion Concentrate Concentrate

(g/l) (mEq/l)
NaHCO3 (Sodium bicarbonate) 84.00 1000
Acid Concentrate
Four different types of acid concentrate are considered:
(a) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 4mEq/l
acetic acid when properly diluted to make dialysate):
Salt Concentrate Concentrate

(g/l) (mEq/l)
NaCl (Sodium chloride) 204.54 3500
KCl (Potassium chloride) 5.22 70
CaCl2 2H2O (Calcium chloride) 7.72 105
MgCl2 6H2O (Magnesium chloride) 2.67 26.25
CH3COOH (Acetic acid) 8.41 140
Table (a)
The following graphs and the related tables (Figs. 9.1 and Fig. 9.3) and Table (f)
refer to this acid composition.
Rev. B
(b) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 4mEq/l

(g/l) (mEq/l)
Table (b)
The following graphs and the related tables (Figs. 9.1 and Fig. 9.3) and Table (f)
(c) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 3mEq/l

(g/l) (mEq/l)
Table (c)
Rev. B
(d) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 3mEq/l

(g/l) (mEq/l)
Table (d)
Note
For Acid Concentrate selection, these are the minimum quantities of acetic acid
recommended for use in a solution, to reduce the possible formation of bicarbonate
precipitates.
Conductivity values of between 2.7 and 3.7 mS/cm, with steps of 0.1 mS/cm, may be
selected.
Average accuracy: 0.1 mS/cm
Alarms: 5% of set value
WARNING
When the conductivity of the dialysate exceeds the alarm threshold, the audible
and visual alarms are triggered.
WARNING
Bicarbonate value in Final Dialysate depends on both the Final conductivity and the
Bicarbonate conductivity settings. It is the responsibility of the user to set
conductivity in accordance with the type of concentrate used to obtain the desired
value of bicarbonate in the final dialysate.
Rev. B
Type 2: BiCart
Use of BiCart:
For the nominal composition of Acid Concentrate Type refers to the tables (a) and (b)
above, for Type 1: BIC 8.4%.
WARNING
Carefully read the BiCart Instructions for Use before using the device. BiCart
may only be used by staff, who are specially trained for haemodialysis treatments,
using the PHOENIX Operators Manual (see Section 5 Dialysis Operation in this
manual).
Type 3: BIC 6.6 %
Bicarbonate Concentrate
Nominal composition of 6.6% Bicarbonate Concentrate type:
Ion Concentrate Concentrate

(g/l) (mEq/l)
NaHCO3 (Sodium bicarbonate) 65.95 785.11
NaCl (Sodium chloride) 23.53 402.64
Acid Concentrate
Nominal composition of 1:35.83 (36.83X) Acid Concentrate type:

(g/l) (mEq/l)
NaCl (Sodium chloride) 172.190 2946.44
KCl (Potassium chloride) 5.490 73.63
CaCl2 2H2O (Calcium chloride) 9.480 128.96
CH3COOH (Acetic acid) 8.850 147.38
Table (e)
The following graphs and the related tables (Figs. 9.2 and Fig. 9.3) and Table (g)
Rev. B
Note
For Acid Concentrate selection, these are the minimum quantities of acetic acid
recommended for use in a solution, to reduce the possible formation of bicarbonate
precipitates.
Conductivity values of between 4.6 and 6.0 mS/cm, with steps of 0.1 mS/cm, may be
selected.
Average accuracy: 0.1 mS/cm

Alarms 5% of set value
WARNING
When the conductivity of the dialysate exceeds the alarm threshold, the audible
Selection Guide for Bicarbonate Concentrate:
Bicarbonate Concentrate Type Acid Concentrate Type

BIC 8.4% 1:34 (35X)
1:44 (45X)
BiCart 1:34 (35X)
1:44 (45X)
BIC 6.6% 1:35.83 (36.83X)
Examples of Correspondence between Conductivity Settings and Dialysate Solute

Content
The following graphs and tables are given as examples of the correspondence
between dialysate conductivity and dialysate solute content for some of the particular
dialysate concentrates listed in this section.
Changes in the concentrate formula will result in changes of the dialysate solute
content so if a different formula is used these graphs and tables may not be
representative.
Rev. B
How to set Conductivity to get a desired

Bicarbonate value in Final Dialysate
Bicarbonate Conductivity mS/cm 3.7

3.6
3.5
3.4
3.3
3.2
3.1
3
2.9
2.8
2.7
28.0 29.0 30.0 31.0 32.0 33.0 34.0 35.0 36.0 37.0 38.0 39.0 40.0 41.0
Bicarbonate value in Final Dialysate mEq/l
Bicarbonate Bicarbonate Final Conductivity

value need Conductivity
30 (mEq/l) 2.8 (mS/cm)
35 (mEq/l) 3.2 (mS/cm) 13.0 mS/cm
40 (mEq/l) 3.6 (mS/cm)
Fig 9.1 Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the BIC.
8.4% solution is used (with Acid Concentrate of the type containing 4mEq/l acetic acid
when properly diluted to make dialysate).
The above graph and table show the effects on Bicarbonate value in Final Dialysate
following adjustments in Bicarbonate Conductivity.
They represent typical values obtained setting Final conductivity to 13.0 mS/cm
when the acid concentrate used are the acid concentrate listed in Table(a) and Table
(b).
Note
Bicarbonate values displayed in the above graph/table are calculated with an
approximation of 1 mEq/l.
Note
If Final conductivity is set to 17.0 mS/cm, bicarbonate value in final dialysate will be
reduced by approximately 1.5 mEq/l from the above graph/table.
Note
If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly
diluted to make dialysate), the Bicarbonate value in Final Dialysate will be increased by
approximately 1 mEq/l. For example, using this concentrate and setting the Bicarbonate
Conductivity to 3.7 mS/cm and the Final Conductivity to 13 mS/cm, the bicarbonate value
in final dialysate will be approximately 42 mEq/l.
Rev. B

Bicarbonate value in Final Dialysate
6.00
5.90
Bicarbonate Conductivity mS/cm
5.80
5.70
5.60
5.50
5.40
5.30
5.20
5.10
5.00
4.90
4.80
4.70
4.60
30.0 31.0 32.0 33.0 34.0 35.0 36.0 37.0 38.0 39.0 40.0 41.0
Bicarbonate value in Final Dialysate mEq/l
Bicarbonate Bicarbonate Final Conductivity

value need Conductivity
30 (mEq/l) 4.6 (mS/cm)
35 (mEq/l) 5.3 (mS/cm) 13.0 mS/cm
40 (mEq/l) 5.9 (mS/cm)
Fig 9.2 Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the
BIC. 6.6% solution is used.
The above graph and table show the effects on Bicarbonate value in Final Dialysate
following adjustments in Bicarbonate Conductivity.
They represent typical values obtained setting Final conductivity to 13.0 mS/cm and
when the acid concentrate used is the acid concentrate listed in Table(e).
Note
Bicarbonate values displayed in the above graph/table are calculated with an
approximation of 1 mEq/l.
Note
If Final conductivity is set to 17.0 mS/cm, bicarbonate values in final dialysate will be
reduced by approximately 1.5 mEq/l from the above graph/table.
Rev. B

Sodium value in Final Dialysate
17.0
16.5
Final Conductivity mS/cm
16.0
15.5
15.0
14.5
14.0
13.5
13.0
130.0 135.0 140.0 145.0 150.0 155.0 160.0 165.0 170.0
Sodium value in Final Dialysate mEq/l
Bic 8.4% / Bic 6.6%

Sodium value need Bicarbonate conductivity Final Conductivity
135 (mEq/l) 13.3 (mS/cm)
140 (mEq/l) 3.7 mS/cm (Bic 8.4%)/ 13.8 (mS/cm)
145 (mEq/l) 6.0 mS/cm (Bic 6.6%) 14.3 (mS/cm)
150 (mEq/l) 14.9 (mS/cm)
155 (mEq/l) 15.4 (mS/cm)
160 (mEq/l) 15.9 (mS/cm)
Fig 9.3 Sodium value in Final Dialysate / Final Dialysate Conductivity.
The above graph and table show the effects on Sodium value in Final Dialysate
following adjustments in Final Dialysate Conductivity.
They represent typical values obtained when is used:
The acid concentrate listed in Table(a) or in Table (b) (for Bic 8.4% or BiCart) and
setting Bicarbonate conductivity to 3.7 mS/cm;
or
The acid concentrate listed in Table(e) (for Bic 6.6%) and setting Bicarbonate
conductivity to 6.0 mS/cm.
Note
Sodium values displayed in the above graph/table are calculated with an approximation of
2 mEq/l.
Rev. B
Note
If the bicarbonate concentrate of the 8.4% type is used, when setting the Bicarbonate
conductivity to 2.7 mS/cm, sodium values in final dialysate will be reduced by
approximately 3 mEq/l from the above graph/table.
If the bicarbonate concentrate of the 6.6% type is used, when setting the Bicarbonate
conductivity to 4.6 mS/cm, sodium values in final dialysate will be reduced by
approximately 3 mEq/l from the above graph/table.
Note
If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly
diluted to make dialysate), the Sodium value in Final Dialysate will be increased by
approximately 1 mEq/l.
Rev. B
Ca++, K+ and Mg++ ions concentration in the Final dialysate
Both when varying the Bicarbonate Conductivity and when varying the Final
Conductivity, the Ca++, K+ and Mg++ ions concentration varies in the Final dialysate
as shown in the following tables:
BIC 8.4% concentrate type
The following table shows the effects on Ca++, K+ and Mg++ values in Final Dialysate
following adjustments in Bicarbonate Conductivity when using a BIC 8.4%
concentrate:
Final Conductivity Bicarbonate Ca++ K+ Mg++

Conductivity (mEq/l) (mEq/l) (mEq/l)
2.7 mS/cm 2.9 2.0 0.73

13.0 mS/cm 3.1 mS/cm 2.8 1.9 0.71
3.7 mS/cm 2.6 1.8 0.66
2.7 mS/cm 3.5 2.3 0.88
15.0 mS/cm 3.1 mS/cm 3.4 2.2 0.85
3.7 mS/cm 3.2 2.1 0.80
2.7 mS/cm 4.1 2.7 1.02
17.0 mS/cm 3.1 mS/cm 4.0 2.6 0.99
3.7 mS/cm 3.8 2.5 0.95
Table (f)
BIC 6.6% concentrate type
The following table shows the effects on Ca++, K+ and Mg++ values in Final Dialysate
following adjustments in Bicarbonate Conductivity when using a BIC 6.6%
concentrate:
Final Conductivity Bicarbonate Ca++ K+ Mg++

Conductivity (mEq/l) (mEq/l) (mEq/l)
4.6 mS/cm 3.5 2.0 0.98

13.0 mS/cm 5.3 mS/cm 3.2 1.8 0.90
6.0 mS/cm 2.9 1.6 0.82
4.6 mS/cm 4.3 2.4 1.22
15.0 mS/cm 5.3 mS/cm 4.0 2.3 1.14
6.0 mS/cm 3.7 2.1 1.05
4.6 mS/cm 5.1 2.9 1.45
17.0 mS/cm 5.3 mS/cm 4.8 2.7 1.37
6.0 mS/cm 4.5 2.6 1.29
Table (g)
Note
Ca++, K+ and Mg++ values displayed in the above tables are calculated with an
approximation of 0.2 mEq/l.
Rev. B
Dialysate Temperature
Range: +34 C (93.2F) to +39.5 C (103.1F)

Accuracy: +1.0 C (+1.8F)/-1.5C (-2.7F)
Alarms: 2 C (3.6F); +32 C (89.6F) min;
+41 C (105.8F) max.
Protection system type: monitoring of the dialysate temperature
WARNING
When the temperature of the dialysate exceeds the alarm threshold, the audible
Dialysate Flow
Possible values: 350 to 800 ml/min with steps of 50 ml/min
Accuracy: 5%
Dialysate Pressure
Permitted values: -350 to +450 mmHg
Accuracy: 25 mmHg
WARNING
When the pressure of the dialysate exceeds the alarm threshold, the audible and
Dialysate Deaeration
Method of Deaeration: heating in combination with vacuum pumping.
Partial pressure of Oxygen: less than 100 mmHg at 40 C (104F) or
dissolved gas in dialysate less than 4.5 mg/l (ppm) .
Rev. B
Dialysate pH
The pH of the dialysate is displayed on the screen.
Accuracy: 0.3 pH units

Range in Bicarbonate mode: 6.5 to 7.6 or 7.8 (depending on service
configuration) pH units
Range in Acetate mode 6.0 to 8.2 pH units
Note
The range for pH is 6.5 to 8.2 pH units only during the preparation phase in BiCart dialysis.
WARNING
When the pH of the dialysate exceeds the alarm threshold, the audible and visual
alarms are triggered.
Dialysate Pump Monitoring for Concentrate Exchange

The reference values for the speed of the acid/acetate and bicarbonate peristaltic
pumps are defined during the corresponding calibration processes and represent the
100% functioning point.
A safety system is present to prevent concentrate exchange errors, by generating an
alarm in case the pumps speeds are measured outside a range of -10% to +30% of
the reference value.
Rev. B
9.2.3 Materials in contact with dialysate, concentrates and water
Ceramic
Ethylene Propylene Diene Monomer (EPDM)
Ethylene Propylene Monomer (EPM)
Fiberglas Reinforced Polyamide (PA + GF -Glass Fiber-)
Fiberglas Reinforced Polypropylene (PP + CF -Carbon Fiber-)
Fluoroelastomer (FKM)
Glass (GLA)
Graphite (C)
High Density Polyethylene (HDPE)
Liquid Cristal Polymer (LCP)
Nitril Butil Rubber (NBR)
Polyester Thermoplastic Elastomer (PTE -Santoprene- )
Polyetheretherketone (Peek)
Polyetheretherketone and Carbon Fiber (Peek + CF)
Polyetheretherketone and Glass Fiber (Peek + GF)
Polyfluorovinylidene (PVDF)
Polyphenysulphide (PPS)
Polypropylene (PP)
Polysulfone (PSU)
Polytetrafluoro Ethylene (PTFE)
Polyvinil Cloruro (PVC)
Silicon Rubber (SI)
Stainless Steel (AISI SS316)
Titanium (Ti)
9.2.4 Descaling
Machine descaling can be carried out using:
The same concentrate solution used for the dialysis procedure (in case of
Bicarbonate Dialysis).
A Vinegar Solution containing at least a 5% concentration of Acetic Acid.
A 5% Acetic Acid Solution.
Rev. B
9.2.5 Disinfection
WARNING
Contact with cleaning and/or disinfection chemicals may pose a risk of burns, skin
irritation or other adverse reactions. Always follow the chemical manufacturer's
instructions when handling these products or cleaning spills.
Disinfectants that may be used for chemical disinfection

The machine can withstand different chemical solutions, which can be classified by
their active ingredient.
Oxidating Chlorine
Active ingredient: Sodium Hypochlorite with active chlorine from 50,000 to 60,000
ppm, chlorine dioxide or active chlorine.
Some commercial products are e.g.:

Bleach
Instrunet HD (*)
Amuchina
Peracetics
Active ingredient: Peracetic Acid from 0.06% to 4%

Actril (*)
Dialox (*)
Renalin (*)
Acetoper (*)
Peresal (*)
Aldehydes
Active ingredient: Formaldehyde Solution at 37-40% or association of different
aldehydes.

Steridial
WARNING
To prevent damaging the machine, do not leave disinfectant solution in the
machine for periods over the following limits:
Rev. B
Note
Chemicals marked with the symbol () carry out a combined action of disinfection and
descaling.
Note
If Bicarbonate Dialysis is carried out, an Acetic Acid cleaning must be performed at least
twice a week (in the case of two normal dialysis sessions per day) to remove the calcium
and magnesium carbonate residuals which may have precipitated in the hydraulic circuit.
To do this, follow the instructions for the disinfection process and automatic rinsing (see
Section 6 Clean/Disinfect in this manual), substituting Acetic Acid solution at 30% v/v
(add 120 ml of pure Acetic Acid to 280 ml of water to obtain 400 ml of solution) for the
chemical disinfectant.
Chemical agents that can be used for Heat Citric Disinfection
The machine can withstand the following chemical solutions:

Citric Acid at a concentration of 50% Citric Acid
WARNING
In the Heat Citric Disinfection phase, it is important that only citric acid is used and
no other disinfectants.
Contact your Local Representative to determine if other chemical agents may be used
for disinfection.
Centralized Heat Disinfection System

The Centralized Heat Disinfection System may be used.
WARNING
When the Centralized Heat Disinfection System is used, the temperature of the
inlet water of the machine must be less than 95C.
Rev. B
9.2.6 Ultrafiltration system
Total Target Weight Loss

The maximum Total Programmable Target Weight Loss is 30 kg to be obtained in a
linear Treatment Time of up to 8 hours.
UF Flow Rate
The minimum UF Rate can be configured (see Section 2 - Configuration Description
in this manual), to 0.0, 0.100, 0.200, or 0.300 kg/h.
The maximum UF Rate is 4.0 kg/h.
Note
If the WLR MIN ALARM parameter is set to 0.0 Kg/h, the minimum value that can be set
for the WEIGHT LOSS/H parameter is 0.100 Kg/h.
The UF Flow Rate accuracy is 2%.
Protection System Type: monitoring of ultrafiltration volume.
WARNING
If the difference between the actual flow of the Ultrafiltration Pump and the set
UFR is greater than 20% with a UF Rate greater than 0.2 kg/h, an audible and
visual alarm is triggered. When this alarm is activated the Ultrafiltration Pump is
stopped.
Flow Balance System

Dialysis fluid flowing into the dialyser and dialysis fluid flowing out from the dialyser
are balanced in order to guarantee that the only fluid removed from the patient is
equal to what is pumped by the UF Pump.
The Flow Balance System (per hour) accuracy is:

35 g/h at a dialysate flow=350 ml/min
Maximum Weight Loss Error (g/h)

The maximum Weight Loss Error (per hour) can be calculated with the following
formula:
WLE = WLEUFR + WLEFBS
where:
WLE = maximum Weight Loss Error
WLEUFR = UFR error related to the UF Flow Rate accuracy
WLEFBS = Flow Balance System error related to the Flow Balance System accuracy
Example: at dialysate flow=500 ml/min and UFR= 0.5 Kg/h

WLEFBS=50 g/h
WLEUFR=10 g/h
WLE=60 g/h
Rev. B
9.2.7 Detection of Extracorporeal Blood Loss
Blood Loss Detection in the event of membrane rupture (Blood Leak Detector)
Elapsed Time before
an alarm: less than 1 min.
Conditions: Dialysate Flow of about 800 ml/min (max specified dialysate
flow).
High Sensitivity: Normalized Blood Loss: 0.35 ml/min of fresh whole human
or bovine blood with a hematocrit of 25%.
Normalized Blood Loss: 0.30 ml/min of fresh whole human
Low Sensitivity: Normalized Blood Loss: 0.45 ml/min of fresh whole human
Normalized Blood Loss: 0.38 ml/min of fresh whole human
Detection Method: Optical Infrared System.
Automatic electronic compensation is performed before starting the DIALYSIS mode.

Operating range of the sensitivity controlled by setting the BLD SENS. Parameter.
A Safety Test of the Blood Leak Detector System is automatically performed each
time the machine enters the Dialysate Preparation phase.
WARNING
In the "UF only" process or with the hydraulic circuit in BYPASS, the Blood Leak
alarm may be delayed, due to the operating conditions and dialyser characteristics.
Blood Loss to the Environment (Venous Pressure Monitoring)

Venous Pressure Accuracy: 20 mmHg or 10% of set value, whichever is
Sensor greater
Venous Pressure -40, +70 mmHg with respect to set value, in Double Needle
Alarms mode.
Operating range: +10 to the value set for the VEN PRESS LIMIT
parameter.
Tolerance: 10 mmHg.
Delay time: about 2 s.
Out of Range Alarms Note: in Single Needle mode only the Out of Range
Alarms are active
Minimum Threshold: +10 mmHg
Maximum Threshold: value set for the VEN PRESS LIMIT parameter
A Safety Test of the Venous Pressure Monitoring System is automatically performed

each time the machine enters the Dialysate Preparation phase
Rev. B
WARNING
Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure
and therefore an alarm may be triggered.
Window is automatically set wider for 30 seconds. Its lower value is set to +10
mmHg, while the upper limit is set to the VEN PRES LIMIT parameter value
decreased of 50 mmHg (see Section 2 - Configuration Description in this manual).
WARNING
Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and
Window is automatically set wider for 30 seconds. Its lower value is set to the value
set for the MIN ART PRESSURE parameter increased of +50 mmHg, while the
upper value is set to +150 mmHg.
WARNING
the environment. When a venous needle disconnects from its access, pressure at
the venous monitoring side may only decrease by the pressure maintained within
the patients access site. This pressure drop may be less than the width of the
machines venous pressure alarm window: in this particular case the disconnection
of a venous needle from its access site is not detectable by the machine, even if
pressure alarms and alarm windows are properly set.
ensure that the patient's access is visible at all times during the dialysis
treatment;
WARNING
A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid
blood loss due to coagulation resulting from interruption of blood flow.
WARNING
In WASHBACK (see Section 5 - Dialysis Operation in this manual) the limits of the
Venous Pressure alarm window are automatically set to -50 and +250 mmHg and
the limits of the Arterial Pressure window are set to the value set for the MIN ART
PRESSURE parameter increased of +50 mmHg and +150 mmHg.
Rev. B
9.2.8 Operating Modes
WARNING
Note
Further information on suitable blood lines can be obtained by contacting your local
representative.
WARNING
The manufacturer recommends the use of a dialyser with dialysate and blood
connections that comply with ISO 8637.
Note
Do not use plate-type dialyser.
Dialysis
Acetate
Bicarbonate with Liquid Concentrates or BiCart
Disinfection
Heat Hot water: >85C (185F)
Process Time: may be set to 18, 36 min or 20, 40 min if the

Clean Dialysate system is installed (with the
DISINF TIME parameter in Config, see
Configuration).
After the Contact Time, the Hydraulic Circuit is cooled with fresh water. Therefore the
total duration of the Heat Disinfection Process is about 10 minutes more than the
Disinfection Time selected.
Rev. B
Heat Citric Hot water: >80C (176F)
Process Time: 24 min or 28 min if the Clean Dialysate

system is installed
Automatic filling with citric acid (about 180 ml).
Automatic verification of the volume of Citric Acid pumped by the

device.
After the Contact Time, the Hydraulic Circuit is rinsed and cooled with fresh water.
The total duration of the Heat Citric Disinfection Process is about 30 minutes.
Chemical Disinfection Time: may be set from 15 to 30 min or from 28 to

43 min if END PROCESS MODE is set to
Bact. (with the DISINF TIME parameter in
Config, see Section 2 Configuration
Description).
Automatic filling with Disinfectant (about 180 ml).
Automatic verification of the volume of disinfectant pumped by the
device.
An Automatic Rinsing Process, performed after the Chemical Disinfection, may be set
by selecting Rins. for the END PROCESS MODE parameter in Config.
The value may be Set to None or Bact. if an Automatic Rinsing is not required.
A Bacteriostatic Disinfection Process may be set: select Bact. for the END PROCESS
MODE parameter in the Config view.
The effectiveness of rinsing to obtain the maximum permitted levels of disinfectant

residuals (measured at a point in the hydraulic circuit just prior to the dialyser
connection) was tested by Gambro Dasco Quality Control and it conforms to
international standards.
Note
It is recommended to alternate the disinfection methods and/or the disinfectants, in order
to optimize cleaning, descaling and disinfection of the machine.
For additional information contact your local representative.
Rev. B
Rinsing
This phase is mandatory after Chemical Disinfection.
The effectiveness of Rinsing (measured at a point in the hydraulic circuit just prior to
the dialyser connection) conforms to international standards for residual
concentrations of disinfectant:
Formaldehyde less than 1.0 ppm

Sodium Hypochlorite less than 0.5 ppm
Time may be set at a value between 15 and 50 minutes or between 19 and 50

minutes if the Clean Dialysate system is installed (RINSING TIME parameter , see
Section 2 Configuration Description in this manual).
Note
The test procedures for the measurement of disinfection and rinsing efficiency are
available, upon request, from the manufacturers quality control department.
WARNING
Verify the absence of disinfectant residuals before connecting the dialyser.
Rev. B
9.3 Extracorporeal Circulation
9.3.1 Operating Modes
Blood Circulation in Dialysis Mode

Double Needle
Single Needle (optional)
Blood Lines
The blood lines are positioned in a way designed to ensure a simple and effective
system. Refer to Chapter 5.0 - Dialysis Operation, in this manual for the mounting
procedure for the Cartridge Blood set.
Cartridge Blood Set

The Gambro/Hospal Cartridge Blood Sets are the only extracorporeal blood circuit
for hemodialysers that may be used with the Phoenix Hemodialysis Delivery
System. The following is the current list of Gambro/Hospal Cartridge Blood Set
models that have been validated for use with the Phoenix Hemodialysis Delivery
System.
Rev. B
Code Application
6032536 Single Needle Conversion Kit
6184071 Double Needle
Double Needle
6186803
(with prime line attached)
6187439 Single Needle
Single Needle
6187686
Double Needle
6280598
003409-410 Single Needle
003410-500 Double Needle


(with prime line attached and injection port on prime line)
003412-500 Double Needle - Low Weight
003429-500 Single Needle Conversion Kit
WARNING
Note
Contact your Local Service Representative for the Gambro/Hospal Cartridge Blood Sets
technical data in order to choose the most appropriate Gambro/Hospal Cartridge Blood Set
for your usage.
Rev. C
WARNING
9.3.2 Blood Pumps
Blood Pump
The Blood Module has one pump specifically designed for dialysis. It is peristaltic and
it is comprised of:
An Electronic Speed Control System to keep the speed constant, independent of
load variations.
A light on the Blood Pump Control Panel is illuminated when the Pump is turning
(or when it is about to turn, for example, after an automatic stop caused by an
alarm).
A Pump Direction Monitor.
Blood Pump stop and automatic closure of the Venous Line Clamp if air or foam is
detected while blood is sensed.
A Safety Control when the Blood Pump Door is open.
A handle for manual turning of the blood pump.
A Protective System to prevent overloads.
Technical characteristics of the Blood Pump

Speed of Pump Head: 0 to 70 rpm approx.
Max Blood Flow (at 70 rpm): 580 ml/min (with Gambro/Hospal Cartridge
Blood Set models that have been validated for
use)
Rev. C
Blood Flow Accuracy (Double Needle Mode)

The machine display shows:
The blood flow set value (displayed as BLOOD FLOW),
The blood flow actual value (displayed as BLOOD FLOW).
The blood flow set value represents the theoretical blood flow rate in the extra-
corporeal circuit calculated from the speed of the blood pump rotor and the
geometric characteristics of the pump segment.
The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit.
The actual value is usually lower than the set value due to the negative pressure in the
access line at the inlet to the pump. The negative pressure is caused by the rotation
of the pump itself and pressure drop linked to the motion of blood in the line. The
actual value coincides with the set value when the pump inlet pressure (arterial
pressure) is zero.
The blood flow actual value is estimated by means of a mathematical algorithm
taking into account the pump segment characteristics of HOSPAL/GAMBRO
Cartridge Blood Set, the current pump speed and the pressure values in the extra-
corporeal circuit.
The accuracy on the estimate, using HOSPAL/GAMBRO Cartridge Blood Set, is
typically within 10% in the following conditions:
the pressure before the pump, given by the pressure in the arterial chamber of
the cartridge, is higher (less negative) than 150 mmHg.
Note
Due to a natural decrease of the pump segment performance during the dialysis treatment, if
the pressure before the pump, given by the pressure in the arterial chamber of the cartridge,
is lower (more negative) than -150 mmHg, the 10% accuracy on the blood flow actual value
estimation may not be guaranteed.
Blood Flow Accuracy (Single Needle Mode)

The machine display shows:
The blood flow set value (displayed as BLOOD FLOW),
The blood flow actual value (displayed as BLOOD FLOW).
The blood flow set value represents the theoretical blood flow rate in the extra-
corporeal circuit calculated from the speed of the blood pump rotor and the
geometric characteristics of the pump segment.
The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit.
The actual value is usually lower than the set value due to the negative pressure in the
access line at the inlet to the pump. The negative pressure is caused by the rotation
of the pump itself and pressure drop linked to the motion of blood in the line. The
blood flow actual value is calculated by using the blood pump activation time and the
blood pump speed value (refer to the Parameter modification paragraph, in the
Section 01 for a detailed description of how to calculate the blood flow actual value
in Single Needle Mode).
The accuracy of the blood flow actual value is typically within 16% in the following
conditions:
the pressure before the pump, given by the pressure in the arterial chamber of
the cartridge, is higher (less negative) than 150 mmHg.
Rev. B
Note
Due to a natural decrease of the pump segment performance during the dialysis
treatment, if the pressure before the pump, given by the pressure in the arterial chamber
of the cartridge, is lower (more negative) than -150 mmHg, the 16% on the blood flow
actual value calculation may not be guaranteed.
Note
In Single Needle mode, the blood recirculation rate at the level of the vascular access is
influenced by the needle type or catheter used. The blood recirculation rate is not due to
the single needle Cartridge Blood Set characteristics.
Blood Flow set

Double Needle 10 to 580 ml/min
Single Needle (option) 10 to 580 ml/min.
(Istantaneous flow) In Single Needle mode the stroke volume for each
cycle is approximately 60 ml.
Alarms If the set value is > 300 ml/min
10%
If the set value is <= 300 ml/min
30 ml/min in Double Needle
105 ml/min in Single Needle
Note
Data relating to haemolysis is available upon request.
9.3.3 Heparin Pump

The PHOENIX machine can be supplied with a syringe type infusion pump which
delivers heparin with either a standard 10 to 20 ml or a 20 to 30 ml syringe.
Heparin Pump Specifications

Maximum Capacity 30 ml
Maximum Delivery Rate in Linear Mode 10 ml/h
Possible Delivery Rate in Linear Mode 0/0.5 to 9.9 ml/h in steps of 0.1 ml/h
Accuracy 5 % or 0.2 ml/h
Maximum pressure +900 mmHg
The delivery of heparin (see Heparinization Section) may be:

Linear: 0/0.5 to 10 ml/h
Automatic Bolus: bolus quantity and internal time are programmed.
Manual Bolus: bolus quantity programmed. The bolus is injected
when the MAN BOLUS Action key is pressed.
Rev. B
Note
If the HEPARIN PR Action key is selected before blood is detected, 0.4 ml of heparin is
injected into the Cartridge to prime the heparin line. This will happen regardless of the
type of heparin programming selected.
Syringes that may be used for Heparin Infusion

Syringe name Volume (ml) Internal diameter
TERUMO 30 23.1 mm (0.909 in)
3S (BERTONI) 30 23.9 mm (0.941 in)
BD 30 PLASTIPAK 30 21.6 mm (0.850 in)
PIC 30 LL 30 23.6 mm (0.929 in)
ICO GAMMA PLUS 30 23.9 mm (0.941 in)
DISPOMED 30 22.3 mm (0.878 in)
PENTA 30 30 21.7 mm (0.854 in)
ICO GAMMA PLUS 20 19.1 mm (0.752 in)
ICO MONOSTERIL 20 19.1 mm (0.752 in)
BD 20 PLASTIPAK 20 19.1 mm (0.752 in)
TERUMO 20 20 20.0 mm (0.787 in)
PIC 20 LL 20 19.6 mm (0.770 in)
PENTA 20 20 20.0 mm (0.787 in)
MONOJECT 20 20 20.1 mm (0.831 in)
MONJECT 12 12 15.7 mm (0.618 in)
BD 10 10 14.4 mm (0.567 in)
TERUMO 10 10 15.8 mm (0.622 in)
WARNING
These diameters have been taken from samples from many countries and are
correct at the time of printing. However, the manufacturer cannot be held
responsible for changes in syringe dimensions that may occur. The user should
periodically check the correlation between the stated and the actual diameters.
Note
It is possible to define a syringe that is not present on the list, by setting, in Config, first
ANOTHER for the Syringe Type parameter, then setting the DIAMETER parameter.
Note
The syringe infusion pump described above must be used only for the infusion of heparin.
Rev. B
9.3.4 Automatic Functions

1. Single Needle - One Pump (optional): arterial/venous cycles occur through
automatic blood pump transition when preprogrammed venous pressure
thresholds are reached.
2. Linear or Bolus heparinization, through programming of the rate and timing of
heparinization.
3. Heparin Bolus Injection Characteristics.
4. Patient Sensor before the Venous Line Clamp
Before blood detection by the Patient Sensor or before the selection of the
DIALYSIS Action key, the class P alarms are bypassed (see Section 8 - Alarms and
Signals in this manual) to allow easier filling of the extracorporeal and dialysate
circuits.
Rev. B
9.3.5 Main Surveillance Devices

1) Monitoring of Arterial Pressure.
The arterial pressure sensor is used to measure pre-pump arterial pressure.
Monitoring the pre-pump arterial pressure is required to protect the patient from high
negative arterial pressures between the patient and the blood pump.
If the pressure falls below a set value, an arterial pressure alarm is triggered.
The alarm threshold can be fixed between the value set for the MIN ART PRESSURE
parameter and +150 mmHg on the Touch Screen.
Accuracy: 20 mmHg or 10%, whichever is greater.
2) Monitoring of Venous Pressure.
See Subsection Blood Loss to the Environment.
3) Ultrasonic Air Bubble Detector.

The blood module has an Air Bubble Detector consisting of:
An Ultrasonic Device located in the Air Detector Housing.
A Transducer which carries out the auto-test approximately every 250 ms.
A Visual and an Audible alarm which is activated if air is detected.
An ultrasonic wave band crosses the fluid in the blood line.

When air is present in the line, the signal received by the detector is modified in
proportion to the volume of air present.
When the signal goes above a fixed threshold, the microprocessor triggers a signal,
which causes the Venous Line Clamp to close and the Blood Pump to stop.
Accuracy: Able to detect a single bubble with a volume approximately of 20 l, with
the blood flow at the maximum allowed value.
4) Monitoring of the Commutation Pressure in Single Needle mode (optional)

The Venous Pressure Sensor is used to measure the blood pressure in the Venous
Chamber for blood pump activation and deactivation in Single Needle mode,
according to set venous pressure values:
Normal operating conditions: from 100 to 400 mmHg

Safety Alarm: over +450 mmHg
WARNING
The user must take precautions against the hazard of cross-contamination between
patients by using only extracorporeal circuits with hydrophobic filters on the
pressure ports and by disinfecting the accessible surfaces of the equipment.
Rev. B
9.3.6 Safety system actuators

1) Arterial Clamp - Optional with Single Needle Feature
2) Venous Line Clamp

The Venous Line Clamp, located below the air bubble detector, performs the
following tasks:
Automatic closure when required by an alarm as part of a specific safety state (see
Section 8 - Alarms and Signals, in this manual).
Closure in Single Needle to reduce recirculation.
The Venous Line Clamp is fitted with a position sensor to ensure proper functioning of
the clamp, and to assure that the Blood Pump is stopped.
Rev. B
9.4 Protection System

The Protection System has the function of controlling fault conditions which may be
dangerous for the patient, by placing the machine in a Safe State, as required by
international regulations.
For each of these conditions, an independent safety chain is implemented. The

conditions controlled are:
Final Dialysate Conductivity

Blood Pump
Bicarbonate Dialysate conductivity
Presence of blood in the Hydraulic Circuit
Concentrate Container Error
Dialysate Flow
Error in the Single Needle mode (optional)
Maximum Dialyser Pressure at the Dialyser Inlet and Outlet
Minimum Dialyser Pressure at the Dialyser Inlet and Outlet
Heater Protection
Voltage Drop of greater than 20 seconds and less than 4 minutes
Voltage Drop of less than 20 seconds
Presence of Air in the Venous Line
Profiling of Final Conductivity Activity
Profiling of Ultrafiltration Rate Activity
Temperature of the Dialysate
Ultrafiltration Flow
Ultrafiltrate Mass Balance
Venous Pressure higher than the maximum permitted
Venous Pressure outside the interval selected or less than the minimum permitted
Arterial Pressure lower than the minimum permitted
Arterial Pressure outside the interval selected or more than the maximum
permitted
Incorrect Voltage
Activity in Profiling Mode.
Activity of Diascan system
Control System Communication checking
Correct Sequence of T1 Tests
Power Failure
Long Bypass
Autoemptying
If, on encountering a fault, the relevant safety state is not correctly configured, the
protection system places the machine in a General Safe State:
1 The Venous Line Clamp is activated.

2 The Power Supply to all other actuators, except those for visual and audible
alarms, is turned OFF.
Rev. B
9.5 General Safety Controls

Use The PHOENIX Haemodialysis System must be used under the
supervision of a physician.
Earth Check that the PHOENIX machine is properly grounded.
Electrical Protection
WARNING
Do not remove the panels. If necessary, ask qualified staff to open the panels.
Disconnect the machine from the main power supply before every cleaning,
checking or maintenance operation.
Risks of Explosion
WARNING
Do not use this machine near flammable gas or flammable anaesthetic mixtures
with air, with oxygen or with nitrous oxide.
Moving Parts
WARNING
Turn the Blood pump OFF before touching the Blood Pump Rotor. Do not touch
the blocking system.
Handling and Transport
WARNING
Carefully move the machine by using the handle on the rear panel.
The machine could be damaged if handled in an improper way.
Use and Maintenance

Read this manual carefully, paying special attention to the notes and observations.
WARNING
Do not assemble, install or use the machine before having read the manual
carefully.
Disposal of Energy Cells

The PHOENIX machine contains energy cells (batteries). When replacing these
components, follow local regulations for proper disposal.
Rev. B
Disposal of discarded equipment

Discarded electromedical equipment may not be disposed of together with municipal
waste but must be collected separately in order to guarantee ecologically correct
disposal to prevent dispersion of potential pollutants into the environment.
Pay attention to the fact that some components of the machine (display, batteries,
circuit boards, etc.) may contain toxic substances which, if released into the
environment, pose a risk to the health of living organisms and the environment itself.
When discarding electromedical equipment used at or through healthcare facilities, it
may be returned directly to the local representative/distributor who has supplied it.
When discarding electromedical equipment used in private households, it may be:
- returned free of charge to the distributor at the time of purchasing new equipment
- sent to the specialized collection centres free of charge.
Users who return electromedical equipment to the subjects identified above actively
contribute to reuse, recycling and recovery of potentially still useable materials and
components and to reduction of the potential risks to the environment and human
health.
Abusive disposal of discarded equipment may be punishable by law.
Rev. B
9.6 Technician Maintenance
WARNING
The manufacturer does not accept any responsibility for damage caused by any
operation carried out on the machine by unauthorized staff.
To keep the machine in good and safe working order, preventive maintenance must
be performed by authorized service technicians. The ambient conditions, as well as
frequency and duration of use determine the maintenance frequency; however when
a maximum of 4,000 hours of use has elapsed (or at least once a year) technical
preventive maintenance is required.
The Manufacturer makes available Preventive Maintenance Kits, including Preventive

Maintenance Checklists, to complete the Technical Preventive Maintenance.
Below is a list of the main operations and verifications required during the Technical
Preventive Maintenance program, updated at the date of printing of this manual. For
a complete description of all the components to be replaced and the calibrations and
checks to be performed refer to the Preventive Maintenance Checklist provided with
each Preventive Maintenance kit and to the calibration/test procedures described in
the Phoenix Service Manual.
Operation Frequency
Change the O-rings Every 4000 hours
Change the BIC/ACE/Sterilant/Dialysate connectors Every 4000 hours
Change the Safety valve Every 4000 hours
Replace the UF, air, hydraulic Filters Every 4000 hours
Replace the O-rings in the BiCart holder arms Every 4000 hours
Change the Peristaltic Pump Inserts and recalibrate the machine. Every 4000 hours
Change the Pressure Ports gaskets Every 4000 hours
EVC and EVD valve body Every 4000 hours
Replace the WHO Connector Cap Every 4000 hours
HLS and LLS level sensors Every 4000 hours
pH sensor Every 4000 hours
During these operations the technician should verify the following:

Leakage in the hydraulic circuit
Leakage in the blood circuit
Correct grounding and hearth leakage current
Power Supply voltages
Correct closing of the clamps
Blood Pump Rotor occlusion
ABD alarm simulation
Power failure simulation
Arterial and Venous Pressure pods
WHO door
Rev. B
Periodic Safety Inspection

A safety inspection of the PHOENIX machine is required at least once a year, or as
stipulated by local requirements. Only trained and qualified technicians are approved
to perform the safety inspection procedures. The inspection consists of the following
tests:
Parameter Performance Conditions

Earth leakage current
Low voltage model < 300 uA (typically < 130 uA) Normal condition
High voltage model < 300 uA (typically < 220 uA) Normal condition
Ground Integrity Test per 0.2 ohm maximum Between earth ground in
IEC 601.1, para 18f mains plug and any
accessible conductive part.
WARNING
Before replacing or checking any component in the Hydraulic Circuit, a
DESCALING Procedure must performed.
WARNING
Rev. B
WARRANTY I
WARRANTY
WARRANTY
All products manufactured by Gambro Dasco S.p.A. are warranted against defects in
workmanship and materials.
While the unit is within the stated warranty period, no service repairs on this machine
should be attempted. Any unauthorized work will immediately void the warranty.
If additional information or assistance is required or the information provided is not
sufficient, contact the Service Representative in your country and request additional
information or assistance.
If any information in this manual is found to be in error, or if there are any additions or
deletions that you feel will improve the manual, please forward your comments to the
Service Representative in your country.
GAMBRO DASCO S.p.A. and/or its affiliates accept responsibility for the safety,
reliability, and performance of this equipment only if:
-- Operational procedures, calibrations, and repairs are carried out by appropriately
qualified persons,
-- All equipment modifications are authorized in writing by GAMBRO DASCO S.p.A. and
carried out by appropriately qualified persons,
-- The electrical installation of the relevant room complies with all applicable local electrical
codes and IEC requirements, and
-- The equipment is used in accordance with the published instructions for use.
IMPORTANT NOTE
SINCE GAMBRO DASCO S.P.A., THE MANUFACTURER, HAS NO CONTROL
OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS
CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING
TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY, OR THE EFFECT OF
SUCH WORK ON MACHINE OPERATION AND PERFORMANCE, GAMBRO
DASCO S.P.A. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY
DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY
DEVICE, OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE
BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS
BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY.
GAMBRO DASCO S.P.A. DOES NOT RECOGNISE THE OWNER OF A PRODUCT
AS AN AUTHORISED SERVICE REPRESENTATIVE.
THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH
ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE
OWNER WILL BE REIMBURSED BY THE MANUFACTURER.
UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR

INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, ITS LIABILITY
HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT.
THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED

WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR
SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE
MANUFACTURER.
Rev. B
II PHOENIX OPERATOR MANUAL
NOTE
The PHOENIX Haemodialysis machine was designed and has been built to comply with the
product specifications listed in this manual (See Section 09 Specifications, in this manual).
Gambro Dasco S.p.A is committed to continuously improving this product. The improvement
process may result in modifications to both the product specifications and consequently to the
equipment produced in the future.
These changes or improvements may or may not be applicable or usable with previously
produced equipment.
Where possible, improvements will be made available at reasonable prices.
Any such improvement shall not be construed as corrections of any perceived deficiency.
NOTE
This manual contains a number of references to spare parts for use with PHOENIX. The
PHOENIX has been tested and validated for use with spare parts listed in this manual. The
Manufacturer does not assume responsibility or liability for use of not genuine spare parts and
for use/mounting of those components not in accordance with the official Instruction for Use
accompanying those components. Depending on the circumstances, use of not genuine spare
parts and use/mounting of those components not in accordance with the above mentioned
Instruction for Use may reduce the Manufacturers warranties for the Phoenix Hemodialysis
System.
WARNING
This manual contains a number of references to accessories and disposables for use with
the Phoenix machine. The Phoenix machine has been tested and validated for use with
the accessories and disposables listed in this manual. The Manufacturer has not validated
the use of accessories or disposables other than those specified in this manual. The
Manufacturer does not assume responsibility or liability for use of accessories or
disposable other than those specified in this manual. It is the responsibility of the user to
validate that other accessories or disposables provide safe and effective performance.
NOTE
This publication contains information which is the property of Gambro Dasco S.p.A. Whoever
receives this manual accepts that drawings and information contained herein must not be
disclosed to others without the express written permission of Gambro Dasco S.p.A.
Do not attempt to assemble, install, or operate the machine until all the contents of this manual
are thoroughly understood.
Rev. B
A APPENDIX A: Guidelines and
Manufacturers Declaration
Electromagnetic Emissions and
Immunity
Appendix A: Guidelines and Manufacturers Declaration Electromagnetic Emissions and Immunity
Guidance and manufacturers declaration electromagnetic emissions

The PHOENIX is intended for use in the electromagnetic environment specified below. The customer
or the user of the PHOENIX should assure that it is used in such an environment.
Electromagnetic
Emission test Compliance
environment - guidance
The PHOENIX uses RF
energy only for its internal
RF emission function. Therefore, its RF
Group 1 emissions are very low and
CISPR 11 are not likely to cause any
interference in nearby
electronic equipment.
RF emission The PHOENIX is suitable for
Class B use in all establishments,
CISPR 11
including domestic
Harmonic emissions establishments and those
Not applicable
IEC 61000-3-2 directly connected to the
public low-voltage power
Voltage fluctuations / flicker
supply network that supplies
emissions Not applicable buildings used for domestic
IEC 61000-3-3 purposes.
For PHOENIX equipment with a rated mains voltage less than to 220V.
Rev. B
A-2 PHOENIX OPERATOR MANUAL

The PHOENIX is intended for use in the electromagnetic environment specified below. The customer
or the user of the PHOENIX should assure that it is used in such an environment.
Electromagnetic
Emission test Compliance
environment - guidance
The PHOENIX uses RF
energy only for its internal
RF emission function. Therefore, its RF
Group 1 emissions are very low and
CISPR 11 are not likely to cause any
interference in nearby
electronic equipment.
RF emission The PHOENIX is suitable for
Class B use in all establishments,
CISPR 11
including domestic
Harmonic emissions establishments and those
Class A
IEC 61000-3-2 directly connected to the
public low-voltage power
Voltage fluctuations / flicker
supply network that supplies
emissions Complies buildings used for domestic
IEC 61000-3-3 purposes.
For PHOENIX equipment with a rated mains voltage greater than or equal to 220V.
Rev. B
APPENDIX A: GUIDELINES AND MANUFACTURERS DECLARATION
ELECTROMAGNETIC EMISSIONS AND IMMUNITY A-3

The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the
user of the PHOENIX should assure that it is used in such an environment.
Floors should be wood,
Electrostatic concrete or ceramic tile.
6 KV contact 6 KV contact If floors are covered
discharge (ESD)
8 KV air 8 KV air with synthetic material,
IEC 61000-4-2 the relative humidity
should be at least 30%.
2 KV for power supply 2 KV for power supply Mains power quality
Electrical fast
lines lines should be that of a
transient / burst
1 KV for input / output 1 KV for input / output typical commercial or
IEC 61000-4-4 hospital environment.
lines lines
Mains power quality
Surge 1 KV line(s) to line(s) 1 KV differential mode should be that of a
IEC 61000-4-5 2 KV lines(s) to earth 2 KV common mode typical commercial or
hospital environment.
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 0.5 cycle for 0.5 cycles Mains power quality
should be that of a
typical commercial or
40 % UT 40 % UT
hospital environment. If
Voltage dips, short (60 % dip in UT) (60 % dip in UT) the user of the
interruptions and for 5 cycles for 5 cycles PHOENIX requires
voltage variations on continued operation
power supply input during power mains
lines 70 % UT 70 % UT interruptions, it is
IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT) recommended that the
PHOENIX be powered
for 25 cycles for 25 cycles
from an uninterruptible
power supply or a
<5 % UT <5 % UT battery.
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power frequency
Power frequency magnetic fields should
be at levels
(50/60 Hz) magnetic
3 A/m 3 A/m characteristic of a typical
field
location in a typical
IEC 61000-4-8 commercial or hospital
environment.
Floors should be wood,
Electrostatic concrete or ceramic tile.
6 KV contact 6 KV contact If floors are covered
discharge (ESD)
8 KV air 8 KV air with synthetic material,
IEC 61000-4-2 the relative humidity
should be at least 30%.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Rev. B
Guidance and manufacturers declaration electromagnetic immunity

The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the
user of the PHOENIX should assure that it is used in such an environment.
Compliance
Immunity test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part
of the PHOENIX including cables, than the
recommended separation distance calculated
from the equation applicable to frequency of the
transmitter.
Recommended separation distance

d = 1.2 P
d = 1.2 P 80 MHz to 800 MHz

Conducted RF 3 Vrms 3 Vrms d = 2.3 P 800 MHz to 2.5 GHz
IEC 61000-4-6 150 KHz to 80 MHz
where P is the maximum output power rating of

Radiated RF 3 V/m 3 V/m the transmitter in watts (W) according to the
IEC 61000-4-3 80 MHz to 2.5 GHz transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of

equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To asses the electromagnetic environment due to fixed transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
PHOENIX is used exceeds the applicable RF compliance level above, the PHOENIX should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the PHOENIX.
b
Over the frequency range 150 KHz to 80 MHz, field strength should be less than 3 V/m.
Rev. B
APPENDIX A: GUIDELINES AND MANUFACTURERS DECLARATION
ELECTROMAGNETIC EMISSIONS AND IMMUNITY A-5
Recommended separation distances between portable and mobile RF

communications equipment and the PHOENIX
The PHOENIX is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the PHOENIX can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the PHOENIX as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum Separation distances according to frequency of transmitter
output power of
transmitter
150 KHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
W d = 1.2 P MHz GHz
d = 1.2 P d = 2.3 P
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, object and people.
Rev. B
Rev. B
B APPENDIX B: Special Troubleshooting
The situations described below are exceptional events. This table provides instructions in
order to solve these problems and prevent them (when possible) from occurring again.
1. GENERAL EVENTS
Situation Remedy
Machine stuck during software loading Switch OFF the machine, wait 5 seconds and
and/or Action keys not available in switch ON the machine again.
IDLE.
Machine stuck after selecting Action Switch OFF the machine, wait 5 seconds and
keys in a fast sequence. switch ON the machine again.
To prevent this situation, do not press the

Action keys too quickly.
Action key not responding at first Select the Action key again.
touch.
2. IDLE
Situation Remedy
Machine stuck in IDLE. Switch OFF the machine, wait 5 seconds then
switch ON the machine.
To prevent this situation, at the machine switch

ON, do not touch the screen until the IDLE view
is displayed.
Audible buzzer and flashing red light Switch OFF the machine, wait 5 seconds, then
active in IDLE. switch ON the machine again.
3. SETUP SELECTION
Situation Remedy
W! SET VALUE OUT OF RANGE # Press OVERRIDE to clear the alarm.
250 alarm occurs after the selection of
the SETUP Action key.
Machine stuck after the selection of Switch OFF the machine; wait 5 seconds, then
the SETUP Action key. switch ON the machine.
Rev. B
B-2 PHOENIX OPERATOR MANUAL
4. PRIME
Situation Remedy
Machine stuck when starting a second Perform another prime.
priming with the PRIME VOLUME
COMPLETED # 54 alarm displayed on the
screen.
5. PATIENT CONNECTION
Situation Remedy
PAT CONNECT Action key present even if Activate the profile curves.
Profile curves have not been activated.
With CentryNet communication system Do not touch the Action key; any data
activated, PATIENT ID Action key still entered will not be effective.
present in Report Page, after patient ID has
been already entered.
6. TREATMENT
Situation Remedy
END OF HEPARIN TIME # 58 alarm To clear the alarm, activate the heparin
displayed even if the heparin program is not program and then deactivate it.
activated.
DIALYSIS TIME parameter not shown in SET If DIALYSIS TIME s to be modified,

environment (when Profiling is activated). deactivate Profiling.
Blood pump running at minimum rate Manually increase the BLOOD FLOW to
instead of at the prescribed rate at the the prescribed value.
beginning of treatment.
!WEIGHT LOSS RATE PROFILE (TIMING) Press OVERRIDE to clear the alarm. If the
# 212 and !CONDUCTIVITY PROFILE alarm persists, switch OFF the machine,
(TIMING) # 210 alarms displayed after the wait 5 seconds, then switch ON the
deactivation of the related profile. machine again.
Rev. B
C APPENDIX C: Ultrafilter Bypass
Connector Installation
This section describes:

1. Disconnection of the three Ultrafilter Bypass connector lines (section C.1);
2. Connection of the Ultrafilter Bypass connector (section C.2).
Material / Instruments needed for the installation

Ethyl Alcohol q.ty 5 ml
Clamp q.ty 3
A pair of gloves q.ty 1
C.1 Disconnection of the three Ultrafilter Bypass connector lines
Setup instructions
1. Put on the gloves.

2. Switch On the machine, the software
program is loaded.
3. At Power ON, information related to the
status of the last machine process appear
on the Touch Screen display (see Fig. 1).
4. Perform a Rinse process, if one of the
following messages appears:
- Rinsing NOT Performed Correctly.
- Chemical Proc. Performed
Correctly.
- Chemical Proc. NOT Performed
Correctly.
WARNING
Fig. 1 Before disconnecting any
component in the hydraulic circuit,
ensure that the hydraulic circuit is
not containing chemicals. If
chemicals in the hydraulic circuit
come in contact with skin, they
might cause chemical injuries.
Rev. B
C-2 PHOENIX OPERATOR MANUAL
5. Switch Off the machine.

6. Unplug the power cord from power
Deaeration supply.
Line 7. Close the water inlet.
8. Follow the instructions below to
disconnect the three Ultrafilter Bypass
connectors lines from the Ultrafilter
Bypass connector (see Fig. 2).
Filtrate
Outlet
Line
Dialysate
Inlet Line
Ultrafilter
Bypass
connector
Fig. 2
Rev. B
APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-3
Disconnection of the Deaeration Line from the Ultrafilter Bypass connector
9. Press the Deaeration Lines snap

safety clip springs then unhook the
snap safety clip from the upper
Deaeration
Ultrafilter Bypass connector port (see
Line
Figures 3 and 4).
Snap
safety
clip
Fig. 3
Snap safety clip

springs
Upper
Ultrafilter
Bypass
connector
port
Fig. 4
10. Slide the Deaeration Lines snap safety

clip along the Deaeration Line and
insert the snap safety clip into the grey
Deaeration Line ring (see Fig. 5 and
Fig. 6).
Grey Deaeration Line ring
Fig. 5 Fig. 6
Rev. B
11. Clamp the Deaeration Line to avoid

water spillage (see Fig. 7).
Deaeration
Line
Fig. 7
12. Disconnect the Deareation Line from

the upper Ultrafilter Bypass connector
port by pulling upwards the
Deaeration Lines Luer lock (seeFig. 8).
Luer lock
Fig. 8
Rev. B
Disconnection of the Dialysate Inlet Line from the Ultrafilter Bypass connector
13. Press the Dialysate Inlet Line s snap

safety clip springs then unhook the snap
safety clip from the lower Ultrafilter
Bypass connector port (see Figures 9
and 10).
Dialysate
Snap Inlet Line
safety
clip
Fig. 9
Snap safety
clip springs
Fig. 10
14. Slide the Dialysate Inlet Lines snap

safety clip along the Dialysate Inlet Line
and insert the snap safety clip into the
grey Dialysate Inlet Line ring (see Fig. 11
and Fig. 12).
Grey Dialysate Inlet Line

ring
Fig. 11 Fig. 12
Rev. B
15. Clamp the Dialysate Inlet Line to avoid

Dialysate
Inlet Line
Fig. 13
16. Disconnect the Dialysate Inlet Line from

the lower Ultrafilter Bypass connector
port pulling downwards the Dialysate
Inlet Lines Luer lock (see Fig. 14).
Luer lock
Fig. 14
Disconnection of the Filtrate Outlet Line from the Ultrafilter Bypass connector
17. Clamp the Filtrate Outlet Line to avoid

Filtrate
Outlet Line
Fig. 15
Rev. B
18. Press the Filtrate Outlet Lines pinch

safety clip springs (Fig. 16) then unhook
Pinch
safety the pinch safety clip from the middle
clip Ultrafilter Bypass connector port (see
springs Fig. 17).
Fig. 16
Pinch
safety
clip
Fig. 17
19. Disconnect the Filtrate Outlet Line from

the middle Ultrafilter Bypass connector
port. (see Fig. 18).
Filtrate
Outlet Line
Fig. 18
Rev. B
Removal of the Ultrafilter Bypass connector
Upper
fixing 20. Remove the Ultrafilter Bypass connector
clip from the lower fixing clip (see Fig. 19).
Lower
fixing
clip
Fig. 19
Rev. B
C.2 Connection of the Ultrafilter Bypass connector
Connection of the Deaeration Line to the Ultrafilter Bypass connector
New 1. Take the new Ultrafilter Bypass connector

Ultrafilter (see Fig. 1).
Bypass 2. Do not insert the new Ultrafilter Bypass
connector connector into the lower fixing clip (see
Fig. 2), since it is necessary to handle the
Ultrafilter Bypass connector.
Fig. 1
Lower
fixing
clip
Fig. 2
Upper 3. Spray the upper Ultrafilter Bypass

Ultrafilter connector port (see Fig. 3) with Ethyl
Bypass
Alcohol (the Ultrafilter Bypass connector is
connector
port symmetric, therefore the upper and lower
Fig. 3
Rev. B
Deaeration
Line
4. Insert completely the Deaeration Lines
Luer lock into the upper Ultrafilter Bypass
connector port (see Figures 4 and 5).
Luer Note
lock
Ensure that the Deaeration Line is not
twisted or kinked.
Fig. 4
Upper
Ultrafilter
Bypass
connector
port
Fig. 5
5. Unclamp the Deaeration Line (see Fig. 6).
Deaeration
Line
Fig. 6
Rev. B
Snap 6. Disconnect the snap safety clip from the

safety clip grey Deaeration Line ring (see Fig. 7).
Fig. 7
Snap 7. Position each of the two Deaeration Lines

safety snap safety clip springs in the housing
clip between the two ribs of the Ultrafilter
Bypass connector (see Fig. 8).
Ribs
Ribs
Fig. 8
8. Hook the snap safety clip to the Ultrafilter

Snap Bypass connector and make sure to hear a
safety clip click sound when it is firmly inserted (see
Fig. 9).
Fig. 9
Rev. B
9. Ensure that the snap safety clip is properly

hooked to the Ultrafilter Bypass
connector: The Deaeration Lines snap
safety clip has to be fully inserted in its
housing in order to avoid line
disconnection. (Fig. 10-A shows a good
installation Fig. 10-B shows a bad
installation due to the gap between the
GOOD BAD Deaeration Lines snap safety clip and the
Fig. 10-A Fig. 10-B Ultrafilter Bypass connector.)
Connection of the Dialysate Inlet Line to the Ultrafilter Bypass connector
10. Spray the lower Ultrafilter Bypass

connector port (see Fig. 11) with Ethyl
Alcohol (the Ultrafilter Bypass connector is
symmetric, therefore the upper and lower
Lower
Ultrafilter
Bypass
connector
port
Fig. 11
Rev. B
11. Insert completely the Dialysate Inlet Lines

Luer lock (see Fig. 12) into the lower
Ultrafilter Bypass connector port (Fig. 13).
Note
Ensure that the Dialysate Inlet Line is
not twisted or kinked.
Luer
lock Dialysate
Inlet Line
Fig. 12
Lower
Ultrafilter
Bypass
connector
port
Fig. 13
12. Unclamp the Dialysate Inlet Line (see Fig.

14).
Dialysate
Inlet Line
Fig. 14
Rev. B
13. Disconnect the snap safety clip from the

grey Dialysate Inlet Line ring (see Fig. 15).
Snap
safety clip
Fig. 15
14. Position each of the two Dialysate Inlet

Lines snap safety clip springs in the
housing between the two ribs of the
Ribs Ultrafilter Bypass connector (see Fig. 16).
Ribs
Snap
safety clip
spring
Fig. 16
Rev. B
15. Hook the snap safety clip to the Ultrafilter

Bypass connector and make sure to hear a
click sound when it is firmly inserted (see
Fig. 17).
Snap
safety
clip
Fig. 17
16. Ensure that the snap safety clip is properly

hooked to the Ultrafilter Bypass
connector: The Dialysate Inlet Lines snap
safety clip has to be fully inserted in its
housing in order to avoid line
disconnection. (Fig. 18-A shows a good
installation. Fig. 18-B shows a bad
GOOD BAD
installation due to the gap between the
Fig. 18-A Fig. 18-B Dialysate Inlet Lines snap safety clip and
the Ultrafilter Bypass connector.)
Connection of the Filtrate Outlet Line to the Ultrafilter Bypass connector
Middle
Ultrafilter 17. Spray the middle Ultrafilter Bypass
Bypass connector port (see Fig. 19) with Ethyl
connector Alcohol.
port
Fig. 19
Rev. B
18. Fully insert the Filtrate Outlet Line onto the

middle Ultrafilter Bypass connector port
(see Fig. 20).
Filtrate
Outlet Line
Fig. 20
Pinch safety
clip 19. Hook the pinch safety clip to the middle
Ultrafilter Bypass connector port (see Fig.
21)
Fig. 21
Rev. B
Pinch
safety clip 20. Ensure that the pinch safety clip is securely
inserted onto the middle Ultrafilter Bypass
connector port in order to avoid line
disconnection (see Fig. 22).
Fig. 22
21. Unclamp the Filtrate Outlet Line (see Fig.

23).
Filtrate
Outlet Line
Fig. 23
Rev. B
22. Insert the Ultrafilter Bypass connector in

the lower fixing clip present on the
machine panel (see the yellow arrow in
Fig. 24).
Lower
fixing clip
Fig. 24
Machine disinfection
23. Plug the Power Cord to power supply.
24. Open the water inlet.
25. Switch On the machine.
26. Perform a Rinse procedure to check for
leaks in the hydraulic circuit. (Please refer
to the Operators Manual, Section 06 for
a detailed description of the Rinse
procedure). During the Rinse process
complete the Final Check checklist as
described at page 19 of this Appendix C.
27. In case a fluid leakage occurs during the
Final Check, switch Off the machine and
repeat the connection procedure of the
improper connections.
28. Perform a Heat Disinfection procedure.
Only if the Heat Disinfection is not
available, perform a Chemical Disinfection
procedure to disinfect the hydraulic circuit
prior to performing a dialysis treatment
(Please refer to Section 06 in this manual
for a detailed description of the Heat and
Chemical Disinfection procedures).
Rev. B
Final Check
Fill in the checklist below to verify if the Ultrafilter Bypass connector replacement procedure has
been correctly performed. To correctly perform the installation procedure all the flags must be
checked.
1. Refer to Figure 25
Check that the Ultrafilter Bypass

connector is properly installed into
the lower fixing clip located on the
machine panel as shown in Fig. 25.
Lower
fixing clip
Fig. 25
Check that no leaks are present in

the Deaeration Line (see Fig. 26,
point A).
Check that the snap safety clip is
correctly hooked to the Ultrafilter
A Bypass connector (see Fig. 26, point
A).
Check that the Deaeration Line is not
twisted or kinked (see Fig. 26, point
A).
Fig. 26
Rev. B

the Dialysate Inlet Line (see Fig. 27,
point B).
Check that the snap safety clip is
correctly connected to the Ultrafilter
Bypass connector (see Fig. 27, point
B).
Check that the Dialysate Inlet Line is
not twisted or kinked (see Fig. 27,
B point B).
Fig. 27

the Filtrate Outlet Line (see Fig. 28,
point C).
Check that the pinch safety clip is
correctly connected to the Ultrafilter
Bypass connector(see Fig. 28, point
C) .
Fig. 28
Rev. B

Manual Usuario Phoenix Gambro (ENG)

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Manual Usuario Phoenix Gambro (ENG)

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Operators Manual

service code 6991376

Questions or comments about this publication can be directed to your Local

2009-2010 GAMBRO LUNDIA AB. All rights reserved.

PHOENIX is a trademark of GAMBRO HOSPAL (Schweiz) AG registered in: Australia,

PHOENIX is a trademark of GAMBRO LUNDIA AB registered in Canada.

GAMBRO is a registered trademark of GAMBRO LUNDIA AB.

HOSPAL is a trademark of GAMBRO HOSPAL Schweiz AG and is registered in Algeria,

Phoenix machine is protected by one or more of the following patents:

EP0243284; EP0403401; EP0428676; EP0418171; EP0465381; EP0467805; EP0501894;

CA1327022; CA2032156; CA2208931; CA1286284; CA1282012; CA1308569;

JP2059115; JP3129326; JP3001235; JP2753242; JP3095223; JP3200594; JP1777042;

IT1241624; IT01267416; IT01256865; IT01320264; IT01320247; AU595423; BR-

Phoenix machine is protected by one or more of the following design registrations:

Indicates that the equipment conforms to Council Directive

Indicates that the equipment conforms to the rules related to the

SECTION PAGES IN REV. C

WARNING: CONSULT ACCOMPANYING DOCUMENTS

TYPE B APPLIED PART

OFF (Main power disconnected)

ON (Main power connected)

PROTECTIVE EARTH (GROUND)

This symbol indicates that:

Name and address of the Manufacturer

Handle with care

(from IEC 601.1)

Operator Manual Symbols

WARNING Very important information related to patient or operator

NOTE Important information related to the correct functioning

Refer to the DIACLEAR Instructions for Use.

An alarm window with the message:

A high volume Audible alarm of 6-2 modulation.

UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR

THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED

1. GENERAL DESCRIPTION............................................................................................................ 1-1

2. CONFIGURATION DESCRIPTION .........................................................................................2-1

3. CENTRAL CONCENTRATE SUPPLY ........................................................................................3-1

3.4.2.2 ADR: RINSE following the Central Bicarbonate Line

5. DIALYSIS OPERATION............................................................................................................... 5-1

5.6.1 Prepare to perform recirculation .............................................................5-36

5.A. SPECIAL PROCEDURES .........................................................................................................5.A-1

5.A.17 Transferring a primed Cartridge Blood Set to another PHOENIX

5.B. TEST PROCEDURES................................................................................................................. 5.B-1

5.C. BLOOD PRESSURE MONITORING SYSTEM................................................................... 5.C-1

5.D. PROFILE ..................................................................................................................................... 5.D-1

5.E. MONITORING.......................................................................................................................... 5.E-1

5.F. CLEAN DIALYSATE System ....................................................................................................5.F-1

6.8 External Cleaning and Periodic Inspections ........................................................... 6-28

7. COMMUNICATION SYSTEM................................................................................................... 7-1

8. ALARMS AND SIGNALS ............................................................................................................ 8-1

A. APPENDIX A: Guidelines and Manufacturers Declaration - Electromagnetic

B. APPENDIX B: Special Troubleshooting ..................................................................................B-1

C. APPENDIX C: Ultrafilter Bypass Connector Installation ....................................................C-1

Tel. 800 525 2623

Tel 514 327 16 35

Gambro Korea Ltd.

Gambro de Mexico S.A. de CV

Gambro Pty. Ltd. (Sydney)

1.1 Structure of the machine

1.1.1 Therapies Description

1.1.2 Structure of the machine

1.2 Description of the machine

1.2.1 Front view

(For machines with Serial Number greater