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C-17PLUS C-22PLUS C-28PLUS

Operating instructions
REVISIONS
The following table lists subsequent editions/revisions of the manual.
The “Description” field brief explains the subject of the latest revision.

Code Rev. Date Description


97050776 0 11-2014 First issue (translation from the original in Italian)

TABLE OF CONTENTS
INTRODUCTION.....................................................................................................................................1
Symbols used in the manual................................................................................................................................ 1
Symbols on equipment........................................................................................................................................... 1
APPLICABLE EUROPEAN DIRECTIVES............................................................................................................................. 1
intended use.................................................................................................................................................................... 1
Important notes.......................................................................................................................................................2
PURPOSE OF THE MANUAL .............................................................................................................................................. 2
GENERAL WARNINGS......................................................................................................................................................... 2

CONTENTS OF THE PACKAGE............................................................................................................3


Dimensions and weight................................................................................................................................................ 3
DESCRIPTION OF THE CONTENTS................................................................................................................................... 3
HANDLING THE PRODUCT................................................................................................................................................. 4

PRODUCT INTRODUCTION..................................................................................................................5
Introduction................................................................................................................................................................... 5
General Characteristics........................................................................................................................................... 5
FRONT................................................................................................................................................................................... 6
REAR..................................................................................................................................................................................... 7
LCD ICONS........................................................................................................................................................................... 8
Operating cycle example........................................................................................................................................... 9

INSTALLATION.....................................................................................................................................10
Introduction................................................................................................................................................................. 10
Compartment dimensions for built-in installations..................................................................................... 10
General installation precautions ...................................................................................................................... 11
Electrical Connections........................................................................................................................................... 11
DIRECT CONNECTION TO A CENTRALized DRAINing point..................................................................................... 12

FIRST START-UP.................................................................................................................................13
Turning on the equipment........................................................................................................................................ 13
MAIN MENU ....................................................................................................................................................................... 14
Filling distilled water ............................................................................................................................................. 15
Manual filling..........................................................................................................................................................15
Automatic filling....................................................................................................................................................15

CONFIGURATION................................................................................................................................16
SETTINGS........................................................................................................................................................................... 16

PREPARING THE MATERIAL..............................................................................................................24


Introduction................................................................................................................................................................. 24
Treating the material before sterilization..................................................................................................... 24
arranging the load.................................................................................................................................................... 25

STERILIZATION CYCLES ..................................................................................................................27

EXTRA DRYING....................................................................................................................................29

I
PROGRAMMED STARTING.................................................................................................................30
RUNNING THE CYCLE....................................................................................................................................................... 31
RESULT OF THE cycle.................................................................................................................................................... 31
DOOR OPENING AT CYCLE END...................................................................................................................................... 31
MATERIAL STORAGE......................................................................................................................................................... 32

TEST PROGRAMS...............................................................................................................................33
Introduction................................................................................................................................................................. 33
cycle Helix Test/B&D................................................................................................................................................... 33
cycle VACUUM TEST...................................................................................................................................................... 35
VACUUM TEST + Helix Test/B&D cycle..................................................................................................................... 36
H2O TEST........................................................................................................................................................................... 36
DOOR OPENING................................................................................................................................................................ 37
USED WATER DRAIN......................................................................................................................................................... 38
Detaching the pipe.................................................................................................................................................38
MANUAL INTERRUPTION ................................................................................................................................................. 38

DATA MANAGEMENT..........................................................................................................................39

APPendix – Technical Characteristics................................................................................50


SUMMARY TABLE.............................................................................................................................................................. 50
Safety Devices.............................................................................................................................................................. 51
Water supply characteristics.............................................................................................................................. 52

APPENDIX – PROGRAMS...................................................................................................................53
INTRODUCTION................................................................................................................................................................. 53
Program Summary Table – C-17 PLUS..................................................................................................................... 54
Program Summary Table – C-17 PLUS.................................................................................................................... 55
Program Summary Table – C-22 PLUS..................................................................................................................... 56
Program Summary Table – C-22 PLUS..................................................................................................................... 57
Program Summary Table – C-28 PLUS .................................................................................................................... 58
Program Summary Table – C-28 PLUS .................................................................................................................... 59
STERILIZATION PROGRAM DIAGRAM............................................................................................................................. 60
DIAGRAMS of THE TEST PROGRAMMES...................................................................................................................... 62
EXAMPLES OF PRINTED REPORTS................................................................................................................................ 63

APPENDIX – MAINTENANCE..............................................................................................................64
Introduction................................................................................................................................................................. 64
Ordinary Maintenance Program........................................................................................................................... 64
Scheduled Maintenance Messages................................................................................................................. 64
Sterilization cycle backup................................................................................................................................ 65
Maintenance Description ........................................................................................................................................ 66
Clean gasket and porthole.............................................................................................................................. 66
Clean external surfaces................................................................................................................................... 66
Clean sterilization chamber and accessories ........................................................................................ 66
Disinfect external surfaces............................................................................................................................ 66
Boiler filter cleaning......................................................................................................................................... 67
Door lock lubrication......................................................................................................................................... 67
Dust filter cleaning.............................................................................................................................................68
Replace the bacteriological filter.............................................................................................................. 68
Water tank cleaning............................................................................................................................................. 68
Boiler gasket replacement.............................................................................................................................. 68
Periodic sterilizer validation................................................................................................................................ 69
DISPOSAL at end-of-life.............................................................................................................................................. 69

APPENDIX – GENERAL PROBLEMS.................................................................................................70


Introduction................................................................................................................................................................. 70
IIII
Analysis and resolution of problems................................................................................................................ 70

APPENDIX – alarms.........................................................................................................................72
Introduction................................................................................................................................................................. 72
alarm intervention..................................................................................................................................................... 72
Alarm during a cycle............................................................................................................................................ 72
SYSTEM RESET................................................................................................................................................................. 73
Alarm Codes................................................................................................................................................................... 74
Analysis and resolution of problems................................................................................................................ 78

APPENDIX – USER DELETION PIN...................................................................................................86

APPENDIX – ACCESSORIES..............................................................................................................87
PRINTER CONNECTION..............................................................................................................................................88

APPENDIX – TECHNICAL SUPPORT.................................................................................................89

III
INTRODUCTION Dear Customer

Thank you for choosing this product. We hope that you will find it completely satisfactory.
This manual describes all procedures for the correct use of the device and instructions for deri-
ving the full benefit from its features.
In any case, we will be available to provide explanations and to receive any suggestions you may
have for improving our products or services.
Symbols used in the NOTE
manual PAY SPECIAL ATTENTION TO PARAGRAPHS INDICATED BY THE POINTING
FINGER.

WARNING
This symbol indicates a potential danger of injury. Follow
the procedures described in the manual to avoid injuring
the user and/or others.

DANGER
This symbol indicates a potential danger of property damage.
Follows the instructions in the manual to prevent potential
damage to materials, equipment or other property.

DANGER
This symbol indicates a potential danger due to high tempera-
ture.

The material the STERILIZER is composed of must be disposed


according to the directive 2002/96/CEE

Symbols on
equipment Potenzial hazard due to high temperature.

Equipment in accordance with applicable directives.

Symbol for disposal in accordante with Directive 2002/95 EC, 2002/96/ EC,
and 2003/108/ EC.

Consult the user manual.

APPLICABLE The product described in this manual is manufactured in accordance with the highest safety
EUROPEAN standards and doesn't represent any danger for the operator if used according to the following
instructions. The product is in accordance with the following European Directive as applicable:
DIRECTIVES
2006/95/CE, for the approximation to the legislation of the Members States related to low vol-
tage equipment.
2004/108/CE, for the approximation to the legislation of the Members States related to the elec-
tromagnetic compatibility;
93/42CEE and subsequent changes, concerning the medical devices.

intended use The product described in this manual is intended exclusively for sterilization of reusable
surgical instruments and materials.

DEVICE INTENDED FOR PROFESSIONAL USE AND NOT FOR SALE TO THE GENERAL
PUBLIC.

WARNING
The device must only be used by qualified personnel. It may
not be used or handled by inexpert and/or unauthorized
personnel for any reason.
This device must not be used for the sterilization of fluids,
liquids or pharmaceutical products.
WARNING

THE STERILIZER IS NOT A MOBILE OR PORTABLE DEVICE.

1
Important notes NOTE
THE MANUAL INFORMATION ARE SUBJECT TO CHANGES WITHOUT ANY
NOTICE.
THE MANUFACTURER IS NOT RESPONSIBLE FOR DIRECT, INDIRECT OR
ACCIDENTAL DAMAGE RESULTING FROM OR RELATING TO THE PROVI-
SION OR USE OF THIS INFORMATION.
THIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR TRANSLA-
TED, IN PART OR IN FULL, WITHOUT THE PRIOR WRITTEN PERMISSION
OF THE MANUFACTURER.

PURPOSE OF The purpose of this manual is to provide instructions for:


THE MANUAL
–– becoming generally familiar with the product;
–– its correct installation and configuration;
–– its safe, efficient use;
–– handling materials before and after sterilization.
Its APPENDIXs also provide:
–– the product's general technical specifications;
–– sterilization program specifications;
–– maintenance;
–– troubleshooting;
–– a variety of other documentation.

When using this product, always follow the instructions in the manual and never use for anything
other than its intended purpose.

WARNING
The user is responsible for all legal requirements related
to the installation and use of this product. The manufactu-
rer will not be responsible for any breakage, malfunctions,
property damage or injury in the event that the product is
not installed or used correctly.

Please observe the following precautions in order to avoid injury or property damage:
–– Use ONLY distilled water of high quality.

WARNING
The use of water of inadequate quality can severely damage
the device.
See Appendix Technical Characteristics in this regard.

GENERAL –– Do not pour water or other liquids on the device;


WARNINGS –– Do not pour inflammable substances on the device;
–– Do not use the device in the presence of gas or explosive or inflammable vapors;
–– Before performing any maintenance or cleaning, ALWAYS DISCONNECT the electricity.

DANGER
Whenever it is not possible to disconnect the electricity to
the device, or if the external power grid switch is far away
or, at any rate, not visible to the maintainer, place a WORK IN
PROGRESS sign on the external power grid switch after tur-
ning it OFF.

–– Make sure the electrical system is grounded conforming to current laws and/or standards;
–– Do not remove any label or nameplate from the device; request new ones, if necessary.
–– Use only original replacement parts.

WARNING
The failure to observe the above, releases the manufactu-
rer from all liability.

2
CONTENTS OF NOTE
THE PACKAGE CHECK THE INTEGRITY OF THE
PACKAGE UPON RECEIPT.

Dimensions Once the package is opened, check that:


A
and weight –– the supply matches the specifications of the order
(see the accompanying document);
–– that there is no obvious product damage;

Dimensions and weight


B C
A. Height 600 mm
B. Width 600 mm
C. Depth 700 mm
Total weight 68 kg

NOTE
IN THE CASE OF A WRONG PRODUCT, MISSING PARTS OR ANY TYPE OF
DAMAGE, IMMEDIATELY PROVIDE A DETAILED DESCRIPTION TO THE RE-
SELLER AND THE TRANSPORTER THAT MADE THE DELIVERY.

DESCRIPTION OF
THE CONTENTS

6
11

5
1
7
4 9
8

2 10
3

In addition to the steriliser, the package contains:

1. No. 5 stainless steel wire instrument tray;


2. Stainless steel wire tray support;
3. Operating documentation (with CD-ROM);
4. Lubricant for door lock mechanism;
5. Tray extractor;
6. Extra bacteriological filter;
7. Rubber hose with quick-coupling for manual water drainage;
8. 1/8” swivel angular connector;
9. 5mm socket wrench for manual door unlocking;
10. Plastic tube for direct water drainage with fastening clamp;
11. Rear spacers

Where possible, the packaged product must be handled using suitable mechanical means (forklift
truck, transpallet, etc.) and following the instructions shown on the package.

3
HANDLING THE In the case of manual handling, the product must be lifted by two persons using the handles cut
PRODUCT in the side of the box.

Once the sterilizer has been taken out of the box, it must be lifted by two persons using appro-
priate means and possibly handled with a lift truck or similar.

WARNING
We recommend that the device be transported and stored
at a temperature no lower than 5 °C. Prolonged exposure to
low temperature an damage the product.

NOTE
KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS
TO BE TRANSPORTED. THE USE OF DIFFERENT PACKAGING COULD DA-
MAGE THE PRODUCT DURING SHIPMENT.

DANGER
Before transport, leave the device turned-off for about 30
minutes after the last program finishes and drain the distil-
led water and used water tanks so that the all the hot inter-
nal parts will have time to cool.

4
PRODUCT The C-17PLUS, C-22PLUS, C-28PLUS series sterilisers are the revolutionary products offered
by Castellini in the field of small water steam sterilisers, equipped with type B (EN 13060) cycles,
INTRODUCTION as well as the new point of reference with respect to safety, performance, flexibility and ease of
Introduction use.

It is a sophisticated but, at the same time, easy to use device that, thanks to its wide range of
configuration options and patented operating devices, satisfies every need for sterilizing medical
devices, guaranteeing the maximum performance under all conditions.

It also features a better way of relating to users who, rather than having to adapt to the machine
and its characteristics, are able to "converse" with it and configure it to meet their own needs.

Thanks to its remarkable ease of use, small size and pleasant appearance, it is the ideal partner
for all professional who demand the maximum sterilization safety.

General
A C-17PLUS, C-22PLUS, C-28PLUS series steriliser is an electronic water steam steriliser that is
Characteristics entirely operated by a micro-processor with a large, printed stainless steel sterilisation chamber.

It is characterized by an advanced fractionated vacuum system for the complete removal of air,
even from hollow, porous materials, and an effective final vacuum drying phase capable of elimi-
nating all traces of humidity from any load.

Its exclusive steam generation system, effective plumbing circuit and electronic management
(supplemented by high-precision sensors) guarantees high process execution speeds and excel-
lent thermodynamic parameter stability.
Moreover, its Process Evaluation System constantly monitors all the machine's “vital” parameters
in real-time, guaranteeing absolute safety and a perfect result.

It offers users 6 sterilization programs (of which one completely PRESETble), all equipped with
customizable, optimized drying for the fast, effective sterilization of the various types of loads
(instruments and materials) used in a medical environment.
All the cycles are directly selectable via the LCD touchscreen, which also al-
lows complete device configuration according to the user’s requirements.

For the first time, a lighting system is available for the working area in front of the sterilization
chamber, which makes the daily operations ever easier and more comfortable.

Please refer to the chapter, “Configuration” for more detail.

Like in the best Castellini tradition, also the new range of C-17PLUS, C-22PLUS, C-28PLUS
autoclaves has the most complete, sophisticated and advanced safety systems available today to
guarantee the user against any electrical, mechanical, thermal or biological malfunction.

NOTE
For the description of the safety devices, refer to the Appen-
dix Technical Characteristics.

5
FRONT

LCD touchscreen
control panel

Door

On/Off switch

Dust filter

Sterilization chamber

Bacteriological filter

Door closing system

Water drain filter

Distilled water top-up quick-


coupling
Distilled water tank drain
quick-coupling (SERVICE
only)
Dust filter

Used water drain quick connector

Door

6
REAR

Rear spacer fastening


slots

Heat exchanger

Connection for Direct


water drainage
Connection for automatic distilled
water filling (only for PURE 100/500
and the automatic filling accessory
kit)
Dust filter

Data label
Ethernet cable connection
(max length 29 m)

Serial cable connection


Automatic filling electrical connection
(only for PURE 100/500 and the automa-
tic filling accessory kit)

Mains fuses

Power cable connection

7
LCD ICONS
TEST TIME AND DATE
CYCLES

SETUP

DATA

TEST
MANAGEMENT

STERILIZATION
CYCLES

MOST
FREQUENTLY MOST DOOR
RUN TEST FREQUENTLY RUN UNLOCK
CYCLE

Sterilizer setting management

Data and information management

TEST Sterilization cycle menu

TEST Test cycle menu

NOTE
OTHER PARTICULAR SYMBOLS RELATED TO THE VARIOUS CONDITIONS OF
USE ARE DESCRIBED IN DETAIL IN THE RELATIVE PARAGRAPHS.

8
Operating cycle The C-17PLUS, C-22PLUS, C-28PLUS series sterilisation programme can be effectively descri-
example bed as a succession of phases, each one with a very precise objective.

For example, the standard program (cycle B, 134°C - 4’): after loading the material in the cham-
ber, closing the door, selecting the program and starting the cycle (after locking the door opening
mechanism), the following sequence will be suggested (see the graph below):

1. preheating the generator and sterilization chamber;


2. removing the air and penetration of the material by steam through a series of vacuum (extraction
of the fluid from the sterilization chamber) and pressure(injection of steam into the chamber)
phases;
3. raising the pressure, with the consequent increase in the temperature of the steam, until reaching
the conditions required for sterilization (in the example, 134 °C);
4. stabilizing the pressure and temperature;
5. sterilizing for the required time (in the example, 4 minutes);
6. depressurizing the sterilization chamber;
7. vacuum-drying phase;
8. ventilating the load with sterile air;
9. bringing the pressure of the sterilization chamber back to the atmospheric level.

Having reached this last phase, you can unlock the door and remove the load from the steriliza-
tion chamber.

It should be emphasized that phases 1, 3, 4, 6 and 9 are identical in all cycles, with slight varia-
tions of duration that are solely dependent on the quantity and consistency of the load and the
heating conditions of the sterilizer while phases 2, 5, 7 and 8 clearly vary their configuration and/
or duration on the basis of the cycle selected (and, as a consequence, the type of load) and the
choices made by the user.

P res s ure (bar)

P R OC E SS
2.10

2.00

1.00

Time (min)
0.00

-0.80

SINGLE VACUUM PULSE VACUUM DRYING

NOTE
PLEASE REFER TO APPENDIX PROGRAMS FOR MORE DETAIL.

9
INSTALLATION The first and fundamental step in achieving good sterilizer operation, long life and complete use
of its features is a correct, careful installation. Moreover, this precaution will avoid the danger of
physical injury or property damage, not to mention malfunctions and damage to the machine. So,
Introduction please follow the instructions in this chapter scrupulously.

NOTE
CUSTOMER SUPPORT (SEE APPENDIX) WILL ANSWER YOUR QUESTIONS
AND PROVIDE ADDITIONAL INFORMATION.
THE STERILIZER HAS PASSED ALL REQUIRED INSPECTIONS BEFORE
BEING PLACED ON THE MARKET. IT DOES NOT REQUIRE ANY ADDITIONAL
CALIBRATION BEFORE BEING PLACED IN SERVICE.

Dimensions and
C-17PLUS C-22PLUS C-28PLUS
weight
A. Height (total) 500 mm
B. Width (total) 480 mm B
C. Depth (excluding
rear connections) A
Note: the sterilizer can 600 mm
however be positio-
ned on a surface only
550mm deep
C
Total weight 50 kg 55 kg 60 kg

Electricity.
The electrical system to which the sterilizer will be connected must be suitably dimensioned ba-
sed on the electrical characteristics of the device.

Compartment When installing the sterilizer inside a cabinet, you must


dimensions provide adequate space all around the device to pro- C
B
vide effective ventilation as well as a large enough
for built-in opening in the back that, in addition to allowing the
installations passage of the power cord will also provide an ade-
quate air flow and the consequent optimum cooling
of the heat exchanger. A

The compartment where the steriliser will be kept must


have the following minimum dimensions:

Dimensions 17-22-28 lt
500 mm with FRONT FILLING KIT
A. Height
670 mm with FILLING FROM THE TOP (door)
B. Width 600 mm

WARNING
Compartment dimensions less than those shown may com-
promise the correct circulation of air around the device
and may not provide adequate cooling, with the consequent
deterioration of performance and/or possible damage.

NOTE
IF THE FILLING AND DRAINAGE DOORS ARE NOT ACCESSIBLE FROM THE
TOP AFTER THE DEVICE HAS BEEN BUILT IN, IT IS ADVISABLE TO USE THE
FRONT ATTACHMENTS (FRONT FILLING KIT).
IF THE MAIN SWITCH IS INACCESSIBLE WHEN INSTALLED IN THE COM-
PARTMENT, USE AN ELECTRIC PLUG THAT INCORPORATES AN ON/OFF
SWITCH.
DO NOT REMOVE THE UPPER COVER OR ANY OTHER EXTERNAL PART.
WHEN INSTALLED IN THE COMPARTMENT, THE DEVICE MUST BE COM-
PLETE WITH ALL ITS PARTS.
PLEASE REFER TO APPENDIX TECHNICAL CHARACTERISTICS FOR COM-
PLETE TECHNICAL DATA.

10
General Obey the following warnings for the correct operation of the device and/or to avoid risky situa-
installation tions:
precautions –– Install the sterilizer on a flat and perfectly horizontal surface.
–– Make sure that the support surface is strong enough to support the equipment weight (about
60 kg);
–– Leave adequate space for ventilation (at least 10 cm on each side) all around the sterilizer,
especially in back.
–– If the device is built-in to a cabinet, be sure to respect the warnings in the preceding paragraph,
avoiding an obstructions to the air intake;
–– Do not install the sterilizer near tubs, sinks or similar places, to avoid contact with water or
liquids. This could cause short circuits and/or potentially dangerous situations for the operator;
–– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
–– Do not install the machine were there is gas or inflammable and/or explosive vapors;
–– Install the device so that the power cord is not bent or crushed. It must run freely all the way
to the socket.
–– Install the device that any external fill/drain tubing is not bent or crushed. They must run freely
to the drain tank.
This information is shown on the back of the machine.

Electrical The sterilizer's must be connected to a socket of the electrical system of adequate capacity for
Connections the device's absorption and ground provided, in conformity with current laws and/or standards.
The socket must be suitably protected by a breaker having the following characteristics:

–– Nominal current In 16 A
–– Differential current IDn 0,03 A

WARNING
THE MANUFACTURER WILL NOT BE LIABLE FOR DAMAGES CAUSED BY
INSTALLING THE STERILIZER ON AN INADEQUATE ELECTRICAL SYSTEM
AND/OR NOT EQUIPPED WITH A GROUND.
NOTE
ALWAYS CONNECT THE POWER CORD DIRECTLY TO THE SOCKET. DO
NOT USE EXTENSION CORDS, ADAPTERS OR OTHER ACCESSORIES.

11
DIRECT CONNECTION –– Remove the cap holding clip on the rear of the autoclave.
TO A CENTRALized –– Fit the plastic tube on the elbow union (provided).
DRAINing point –– Fit the union and then refit the clip.
–– Fasten the clip provided to the drain siphon.
–– Cut the hose to the right length and insert its free end into the centralized draining connector
locking it with the dedicated ring nut.

NOTE
MAKE SURE THE TUBE IS NOT BENT, CRUSHED OR OBSTRUCTED IN ANY
WAY.

The following diagram provides an indicative arrangement of the components:

Drain
siphon

Support
plane
Clamp
To the centralized
draining point

NOTE
THE CONNECTION POINT TO THE CENTRAL DRAIN MUST BE LOWER
THAN THE STERILIZER'S SUPPORT SURFACE. OTHERWISE, THE TANK
MAY NOT EMPTY CORRECTLY.

NOTE
FOR AUTOMATIC FILLING SYSTEMS (PUMP, PURE 100, PURE 500, EV7)
THE DIRECT DRAIN MUST ALWAYS BE CONNECTED.
THIS ACTS AS AN OVERFLOW, AND, IF FOR SOME REASON, THE FILLING
SYSTEM DOES NOT STOP, THE WATER SEEPS FROM THE FEED TANK
INTO THE DRAIN TANK AND FLOWS OUT THE DIRECT DRAIN, THUS PRE-
VENTING FLOODING.

12
FIRST START-UP Once the sterilizer has correctly been installed, turn it on with the main switch on the right-hand
side of the machine.

Turning on the
equipment

WARNING

DO NOT TURN ON THE STERILIZER, IF USB KEY IS INSERTED.

When the sterilizer is turned on, the following page appears:

CASTELLINI

80%

13
MAIN MENU At first start, the autoclave guides you through configuration: select the language, date and time.

Language

Italiano
English
Deutsch

Date and Time


GMT hh mm DD MM YYYY

+1 05 30 15 06 2013

Once the start procedure has been completed, the main menu shown below appears on the
display.

TEST

The device waits for selection of the desired program (see section “Program Selection”).

DANGER

To prevent burns, be careful not to touch the sterilization


chamber, the chamber equipment or the inside of the door
with bare hands.

14
Filling distilled The first time the sterilizer is used, and later when the MIN water level indicator comes on, you will
water have to fill, or top-off, the internal distilled water tank.

Open the loading door.

Manual filling Pour in water taking care not to exceed the maximum level (MAX) indicated inside the tank. Close
the door.
Be carefulnot to spill any water on the machine, and if so, immediately dry it off.

BEEP

WARNING
THE TANK MUST BE FILLED BEFORE THE CYCLE STARTS OR AFTER ITS
COMPLETION.
DO NOT OPEN THE TANK DOORS DURING CYCLE EXECUTION IN ORDER TO
PREVENT WATER LEAKS.

Automatic filling Refer to the Appendix "ACCESSORIES".

15
CONFIGURATION The C-17PLUS, C-22PLUS, C-28PLUS series offers a wide range of customisation options. The
user can thus configure the device according to need, adapting the performance based on, for
example, the type of activity carried out, the type of material to be sterilized and the frequency of
use.
Using the configuration program, the user can set a series of options available in user-friendly
menus.

NOTE
USE THE SETUP PROGRAM WHENEVER NECESSARY. A CORRECTLY PER-
SONALIZED DEVICE PROVIDES THE BEST PERFORMANCE AND THE MOST
SATISFACTORY USE.

CUSTOMER SUPPORT (SEE APPENDIX) IS AVAILABLE TO HELP USERS BY


PROVIDING SUGGESTIONS OR ADVICE ON THE BEST WAY TO USES THE
OPTIONS IN THE SETUP PROGRAM.

SETTINGS
To access the configuration program, tap the button shown in the figure.

TEST

Language Date and Time User

Standby Preferences

LANGUAGE

Language Date and Time User

Standby Preferences

Select the desired language using the scroll arrows.

Language

Italiano
English
Deutsch

16
DATE AND TIME

Language Date and Time User

Standby Preferences

Use the cursors shown in the figure to adjust the hours, minutes and display settings.

Tap to confirm the selection.

Date and Time


GMT hh mm DD MM YYYY

+1 05 30 15 06 2013

time zone hours minutes day month year

17
USER

Language Date and Time User

Standby Preferences

ADMIN USER MANAGEMENT

At first use, create the ADMIN user (identified with an *) following the indications in the figure be-
low. Enter the ADMIN username and PIN in the relative fields. Tap to confirm.

Nico_ Nicola*
.,- 1 abc 2 def 3
ghi 4 jkl 5 mno 6
pqrs 7 tuv 8 wxyz 9 1547
0

After registration of the ADMIN user, the following page is displayed when accessing user mana-
gement.
Select the user from the list.

User

Nicola*

Enter the PIN. Tap to confirm.


Nicola*

1547

NOTE
IF THE ADMIN USER ENTERS THE PIN INCORRECTLY THREE TIMES, THE
SYSTEM IS LOCKED AND THE UNLOCKING PROCEDURE DESCRIBED IN
THE APPENDIX “ADMIN USER PIN RESET” NEEDS TO BE USED

The ADMIN user can decide whether the sterilizer should ask the generic user for a PIN at the
start of the cycle (PIN START) and/or at the end of the cycle (PIN END).
Tap ON to activate the PIN request or OFF to deactivate it.

Nicola*

PIN START

+
New user PIN END

Tapping NEW USER, the ADMIN user can create a new generic user following the instructions
described above.

Tapping USER LIST, you access the user list.

18
Nicola*

Nicola*
Marco

Tapping the button, you obtain the data relating to the user highlighted:

Nicola*

User ID: 0003


PIN change Name: Marco Rossi
User creation date:
12/02/12
Cycles run: xxx/yyy
Admin

The ADMIN user can change the PIN of the user highlighted in the user list by directly entering the
new PIN or promote the user to ADMIN.

Tapping the button, the ADMIN user can delete the user highlighted in the list.
Nicola*
Warning
Are you sure you
want to delete the
Nicola* user "Marco"?
Marco OK

Confirm deletion by tapping OK or the button to go back.

Tapping the button, the ADMIN user can select the cycles the selected user is authori-
sed to run by tapping the corresponding icons.

Marco

B 134 B 121 B 134

S 134 S 134
Solid Hollow

19
USER MANAGEMENT

After registration of the generic users, the following page is displayed when accessing user ma-
nagement.
Select the pertinent generic user from the list.

Nicola*
Marco
Chiara

Enter the PIN.


Marco

1547

Generic users can change their PIN by directly entering the new PIN, view the cycles they are
authorised to run and view their data.

Marco
User ID: 0003
Nom: Marco Rossi
PIN change
Date création utilisateur:
12/02/12
Cycles effectués:xxx/yyy
Admin

The cycle list is read-only for generic users (not ADMIN).


Marco

B 134 B 121 B 134

S 134 S 134

20
STANDBY

Language Date and Time User

Standby Preferences

30

Tap the ON/OFF icons to activate or deactivate sterilization chamber heating during standby.
Use the cursors to set the heating off delay.

Tap to confirm.

PREFERENCES

Language Date and Time User

Standby Preferences

Selecting the preferences icon, the following page is displayed.

Preferences

H2O filling Unit of measure Display

21
H2O filling
Preferences

H2O filling Unità di misura


Display

When connecting the automatic filling system, the sterilizer asks you to identify the type of device
actually connected by tapping the corresponding button.

Manual filling

Pure 100
Pure 500

If connecting the filling system when the sterilizer is off, access the menu via the configuration
program and manually select the correct option.

NOTE
THIS MENU CAN ALSO BE USED TO TEMPORARILY DEACTIVATE THE AU-
TOMATIC FILLING SYSTEM (FILTERS EXHAUSTED, FAULT, ETC.) AND GO
TO MANUAL TANK FILLING.

UNIT OF MEASURE
Preferences

H2O filling Unit of measure Schermo

Set the desired units of measure (temperature, pressure), the time (12 or 24 hours) and the date
using the cursors shown in the figure.

Unit of measure

°C bar 12h dd:mm:yy

temperature pressure time date

22
SCREEN
Preferences

H2O filling Unit of measure Display

Tapping the icon shown in the figure above, you can select the screen and LED bar settings.
Selecting White or Blue, you set the main theme colour.
The three cursors on the left-hand side respectively adjust:
- LED bar off timeout
- screen brightness
- Screensaver activation timeout (the current time is displayed).

Display

20’ 15’ 60%

LED brightness screen-


SERVICE saver

This menu is reserved for Technical Service.

Language Date and Time User

Standby Preferences

It may only be used by an authorised technician.

23
PREPARING THE First of all, it should be recalled that, when handling and managing contaminated material, it is
a good idea to take the following precautions:
MATERIAL
–– Wear rubber gloves of adequate thickness;
–– Clean your gloved hands with a germicide detergent;
Introduction
–– Always carry the instruments on a tray;
–– Never carry them in your hands;
–– Protect your hands from contact with any sharp points or edges; this will avoid the risk of
contracting a dangerous infection;
–– Immediately remove any article that does not need to be sterilized or that is not capable of
withstanding the process;
–– Carefully wash your still gloved hands when done handling non-sterile material.
All materials and/or instruments to be sterilized must be perfectly clean, without any type of re-
sidue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime, etc.).

NOTE
IN ADDITION TO CAUSING PROBLEMS DURING STERILIZATION, THE FAI-
LURE TO CLEAN AND REMOVE RESIDUE CAN DAMAGE THE INSTRU-
MENTS AND/OR THE STERILIZER, ITSELF.

Treating the An effective cleaning consists of the following:


material before 1. Rinse the instruments under running water immediately after use;
sterilization
2. Separate metal instruments by type of material (carbon steel, stainless steel, brass, aluminum,
chromium, etc.), to avoid electrolytic oxidation-reduction;
3. Wash in an ultrasound cleaner using a mixture of water and germicidal solution, carefully following
the manufacturer's recommendations.
4. For best results, use a detergent specifically designed for ultrasound washing, with a neutral pH.

NOTE
SOLUTIONS CONTAINING PHENOLS OR QUATERNARY AMMONIA COM-
POUNDS CAN CAUSE CORROSION ON INSTRUMENTS AND THE METAL
PARTS OF ULTRASOUND DEVICES.
5. After washing, carefully rinse the instruments and make sure that residues have been completely
eliminated; if necessary, repeat the washing cycle or clean manually.

NOTE
TO AVOID THE FORMATION OF LIME SPOTS, RINSE WITH DEIONIZED OR
DISTILLED WATER, IF POSSIBLE. WHENEVER VERY HARD TAP WATER IS
USED, WE RECOMMEND ALWAYS DRYING THE INSTRUMENTS.

For handles (turbines, contra-angles, etc.), supplement the above with treatment in suitable dedi-
cated devices that provide effective internal cleaning (occasionally including lubrication).

NOTE
THE END OF THE STERILIZATION PROGRAM, REMEMBER TO LUBRICATE
THE INTERNAL HANDLE MECHANISMS USING THE SPECIAL STERILE OIL.
BY TAKING THESE PRECAUTIONS, THE INSTRUMENTS USEFUL LIFE WILL
NOT BE REDUCED IN ANY WAY.

WARNING
CONSULT THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF
THE INSTRUMENT/MATERIAL TO BE STERILIZED BEFORE SUBJECTING
IT TO AUTOCLAVE TREATMENT, CHECKING FOR ANY INCOMPATIBILITIES.
SCRUPULOUSLY FOLLOW THE METHODS OF USING DETERGENTS OR DI-
SINFECTANTS AND THE USAGE INSTRUCTIONS OF THE AUTOMATIC DE-
VICES FOR WASHING AND/OR LUBRICATING THEM.

24
On the other, as regards textile material (or porous, in general), such as smocks, napkins, caps
and other, carefully wash and then dry them before treating them in the autoclave.

NOTE
DO NOT USE DETERGENTS WITH A HIGH CONTENT OF CHLORINE AND/
OR PHOSPHATES. DO NOT BLEACH WITH CHLORINE-BASED PRODUCTS.
THESE SUBSTANCES CAN DAMAGE THE TRAY SUPPORTS, TRAYS AND
ANY METAL INSTRUMENTS THAT MAY BE PRESENT IN THE STERILIZA-
TION CHAMBER.

arranging Follow the instructions below for the most efficient sterilization process, preserve the material and
increase its useful life.
the load
General notes for positioning on trays:

–– Arrange instruments made of different metals (stainless steel, tempered steel, aluminum, etc.)
on different trays or well separated from each other;
–– In the case of instruments not made of stainless steel, place a paper sterilization napkin or a
muslin cloth between the tray and the tool, avoiding direct contact between the two different
materials;
–– In any case, arrange the objects sufficiently distant from each other that they will remain so for
the entire sterilization cycle;
–– Make sure that all instruments are sterilized in an open position;
–– Position cutting instruments, (scissors, scalpels, etc.) so they can not come into contact with
OK
each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and protect
them;
–– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so avoid
pooling water;
–– Do not load trays beyond their indicated limit (see Appendix A).
–– Since this value is understood to be the maximum allowed limit, it can be excessive in some
cases, so always use common sense.
–– Do not stack trays or put them in direct contact with the walls of the sterilization chamber.
OK
–– Always use the tray support provided.
–– To insert and extract trays from the sterilization chamber, always use the extractor provided.

NOTE
PLACE A CHEMICAL STERILIZATION INDICATOR ON EVERY TRAY TO IN-
DICATE THAT THE PROCESS HAS OCCURRED: THIS AVOIDS USELESSLY
REPROCESSING THE SAME LOAD OR, WORSE, USING NON-STERILIZED
MATERIAL. IF PROCESSING WRAPPED MATERIAL, PLACE THE INDICATOR
INSIDE ONE OF THE WRAPPINGS.

25
Notes for rubber and plastic tubing

OK – Always rinse before use with pyrogen-free water; do not dry them;
– Arrange the tubing on the tray so that their ends are not obstructed or crushed.
– Do not bend or wind them, but allow them to lie as straight as possible.

Notes for packets and packages

– Arrange packages side-by-side, suitably spaced and absolutely not piled, to avoid their co-
ming in contact with the walls of the chamber.
– Whenever it is necessary to wrap particular objects, always use suitably porous material (ste-
OK
rilization paper, muslin napkins, etc.), closing the wrapping with autoclave adhesive tape.

Notes for wrapped material

– Wrap instruments individually or, when more than one instrument are placed in the same
wrapping, make sure that they are made of the same metal;
– Seal the wrapping with adhesive tape for autoclaves or heat-sealing machines.
– Do not use staples, pins or other fasteners since they can compromise the maintenance of
sterility;
– Arrange the envelopes so as to avoid forming air pockets that obstruct the correct penetration
OK
and removal of the steam.
– Orient the envelopes so as to leave the plastic side up and the paper side down (tray side).
– In any case, check that they are correctly positioned, turning them over, if necessary.
– If possible, place the envelopes edgewise to the tray, with a suitable support.
–– Never superimpose envelopes on top of each other.

WARNING
If longer storage is recommended, always pack the instru-
ments using packaging materials conform to EN 868. SEE THE
CHAPTER, “PRESERVING STERILIZED MATERIAL”.

A sterilization cycle consists of a determined number of phases.

Program selection is fundamental for a successful sterilization process.


Since each instrument, or material in general, has different shape, consistency and properties, it
is important to identify the most suitable program for it, both for preserving its physical cha-
racteristics (avoiding or, at any rate, limiting alterations) as well to guarantee the most effective
sterilization.
A guide to selection of the program suited to the load is given in the Appendix Programs.

26
STERILIZATION A sterilization cycle consists of a determined number of phases. The number and duration of the
phases can differ for the programs, based on the type of air extraction, sterilization process and
CYCLES drying method.

The electronic control system monitors the various phases, at the same time checking that the
various parameters are respected; if any type of anomaly is encountered during the cycle, the
program is immediately interrupted, generating an alarm identified by a code, with a relative mes-
sage explaining the nature of the problem.

With this type of control, when you select a suitable sterilization program, you are guaranteed
perfect sterilization under any conditions.

After inserting the load in the sterilization chamber (taking the precautions described in the sec-
tion “Preparing the material to be sterilized”) , select the desired sterilization cycle as follows:

TEST

B 134 B 121 B 134


Prion

S 134 S 134
Solid Hollow

Start the cycle by tapping the button shown in the figure.


The cycle counter appears at the top left.

00056

4’ 1 bar 28°C

Process Nominal Nominal


Time process process
pressure temperature

27
USER-DEFINED CYCLE

To set the parameters, select the button as shown below:

B 134 B 121 B 134


Prion

S 134 S 134
Solid Hollow

Tap and hold the button shown below to access the settings:

00056 User settings

>3 S
4’ 1 bar 28°C

Select the type of pre-vacuum, the process temperature, the exposure time and extra drying if
necessary.
User settings

20
20

Once you have made the selections, tap the button to save the settings and go back
to the previous page.
Tap the START button to start the user-defined cycle.
00056 User settings

4’ 1 bar 28°C

28
EXTRA DRYING
To set the parameters, select the button as shown below:

B 134 B 121 B 134


Prion

S 134 S 134
Solid Hollow

Tap and hold the button shown below:

00056

>3 S

4’ 1 bar 28°C

Set the minutes of drying you want to add to the standard drying time.

20

The value set will appear next to the button.


Start the cycle.

00056

+20
28°C
4’ 1 bar

NOTE
AT NEXT USE, JUST TAP THE EXTRA DRYING BUTTON TO ACTIVATE THE
VALUES PREVIOUSLY SET.

29
PROGRAMMED To set the parameters, select the button as shown below:
STARTING

B 134 B 121 B 134


Prion

S 134 S 134
Solid Hollow

Tap and hold the button shown below:

00056

>3 S

4’ 1 bar 28°C

Set the time when you want to start the cycle selected.

15/12/13
09:30
1:30

The time set will appear next to the button.


Tap the START button; the cycle will automatically start at the time set.
00056
15/12/13
09:30

4’ 1 bar 28°C

NOTE
AT NEXT USE, JUST TAP THE PROGRAMMED START BUTTON TO ACTIVA-
TE THE VALUES PREVIOUSLY SET.

30
RUNNING THE CYCLE Taking as example the most complete and significant sterilization cycle, i.e. the 134°C UNIVER-
SAL program, characterised by fractionated pre-vacuum, the cycle sequence is as follows:

WARMING UP

PRE-HEATING

00:42

FIRST VACUUM PHASE


FIRST PRESSURE RISE
SECOND VACUUM PHASE
5SECOND PRESSURE RISE
THIRD VACUUM PHASE
THIRD PRESSURE RISE
STERILIZATION
STEAM DISCHARGE
DRYING
VENTILATION
CYCLE COMPLETION

CYCLE COMPLETE

00:42

RESULT OF If the message "CYCLE COMPLETE" appears, it means that the cycle has completed correctly
without any interruptions for alarms and that complete asepsis of the material is guaranteed.
THE cycle

DOOR OPENING To open the sterilizer door, press the button shown in the figure:
AT CYCLE END

CYCLE COMPLETE

00:42

31
MATERIAL STORAGE The sterilized material must be adequately treated and stored to maintain its sterility over time,
until its use.

Inadequate storage can cause rapid recontamination.

This leads to problems regardless of what you do since you will either be using recontaminated
material (most of the time unconsciously), placing the user and patient at risk, or you will have to
run the sterilization cycle again, with an inevitable waste of time and resources.

For this reason, we think it will be useful to provide several basic suggestions, leaving the opera-
tor the task of further study of specific texts.

Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the following
precautions should be taken when handling and/or carrying sterile material:

1. Remove the load from the sterilization chamber wearing gloves and a clean, or even better,
sterilized smock. As an additional precaution, wear a protective mask on your face;
2. Rest the tray on a dry, suitably clean and disinfected surface. Take care to distance or, at any
rate, separate the sterile material from the area where contaminated material is kept waiting
to be sterilized;
3. Touch the material and/or instruments as little as possible, taking extreme care not to cut or
damage the wrappings;
4. Let the instruments cool before any transport (and subsequent storage). If necessary for transport,
transfer the material using dry, clean and disinfected containers. The containers must be
closed or, if open, covered with clean cloths.

Sterile material waiting for used must be stored using the appropriate techniques. These will
significantly slow recontamination:

1. Store the material and/or instruments in the protective wrappings that were used during
sterilization. Do not wrap the instruments after sterilization since, in addition to being useless
and completely senseless, is also potentially damaging;
2. Store the material in a dry, suitably clean and disinfected place, far from the area where infected
material passes. If possible, use closed compartments equipped with ultraviolet light;
3. Identify the sterile material by attaching the sterilization data (attaching a copy of the printed
report or an adhesive label);
4. First use the material that has been stored the longest (FIFO, "First In First Out"). This results
in material that is homogeneously stored, avoiding storing for too long, with the consequent
risks.
5. Never store material for too long. In fact, do not overlook the fact that materials will tend to degrade
and be recontaminated in a finite time, even when the above instructions are followed.

NOTE
Consult the specifications provided by the manufacturer of
the packaging material relative to the maximum allowed stora-
ge time. In the absence of appropriate instructions, do not exceed
the following storage periods:

Basket with sealing ring or container without ga-


1-2 days
sket
Container with filter and gasket or container with
30 days
valves.
Single-ply “Medical Grade” paper 1-2 days
Double-ply “Medical Grade” paper (orthogonal) 30 days
Polyester / polypropylene paper covering, single 30 days
Polyester / polyproylene paper covering, double 60 days

The values indicated refer to material that has been properly


stored.

32
TEST PROGRAMS To protect the safety of users and patients, a fundamental process like sterilizing medical devices
should be periodically checked.

In this regard, the C-17PLUS, C-22PLUS, C-28PLUS series offer the possibility of easily and
Introduction
automatically executing two distinct test cycles:
• Helix/B&D Test
• Vacuum Test
a program that executes the two tests combined is also available (Vacuum Test + B/D Test).

There is also a further test to check the water quality: H2O TEST.

Helix/BD Test is a cycle run at 134°C characterised by a sterilization phase that lasts a specific
time (3.5 minutes); the cycle comprises the fractionated vacuum phases similar to those used in
the UNIVERSAL cycles.
Using an appropriate device, you can assess correct steam penetration into hollow loads.
The cycle is also suitable to measure steam penetration into porous loads (Bowie & Dicktest
pack).

cycle Helix To select the Helix/B&D Test cycle, tap on the corresponding button and then on START.
Test/B&D

TEST

00056 Helix / B&D Test

4’ 1 bar 28°C

Helix / B&D Test


PRE-HEATING

00:42

33
The test device (in accordance with EN 867-5 specifications) consists of a 1.5m-long PTFE tube
with an inside diameter of 2mm to whose end a small hermetically-sealed screw cap is fastened,
able to contain an appropriate chemical indicator. The other end of the tube is left free so that the
steam can penetrate and you can assess its effectiveness.

To conduct the test (with reference to EN 13060), insert the chemical indicator (consisting of a
paper strip with a special reagent ink) in the device cap (always to be used perfectly dry). Tighten
the cap in such a way that seepage through the gasket is not possible.

NOTE
The test device and the chemical indicators to execute the
Helix/BD Test cycle are not provided with the sterilizer. For
information in this regard, contact Customer Service (see Ap-
pendix).
Place the device roughly in the middle of the central tray. Do not insert other material in the cham-
ber. Close the door and start the cycle.

The test cycle takes place with a succession of phases similar to those described for a normal
sterilization cycle.
At the end of the cycle, remove the test device from the chamber, open the cap and remove the
indicator from its housing.
If the steam has correctly penetrated, the ink will have completely changed its original colour
over the entire length of the strip; if not (insufficient penetration), there will only be a partial colour
change or even no change at all.

NOTE
Normally, the colour changes from a light colour (beige,
yellow, etc.) to a dark colour (blue, violet or black). In any
event, strictly follow the instructions and any additional
technical details provided by the indicator manufacturer.

34
cycle VACUUM TEST The Vacuum Test cycle allows testing perfect seal of the sterilizer hydraulic system.
Measuring the variation of the degree of vacuum in a defined time-frame and comparing it with
pre-established limit values, you can determine how good the seal of the sterilization chamber,
tubes and the various interception devices is.

To select the Vacuum Test cycle, select Vacuum Test using the arrows and confirm with OK.

TEST

00056 Vacuum Test

4’ 1 bar 28°C

Vacuum Test
VACUUM

00:42

35
The Vacuum Test program is run with the sterilization chamber empty, and only the trays and
their supports.
NOTE
RUN THE VACUUM TEST AS THE FIRST CYCLE AFTER POWERING-ON THE
EQUIPMENT.

A high chamber temperature affects the variation in the vacuum value measured during the test;
the system is therefore programmed to prevent execution of the test when the operating condi-
tions are inadequate.
Close the door and start the program.
The vacuum phase starts immediately and the pressure value (bar) and the countdown from the
start of the test cycle is shown on the display.
NOTE
If the pressure variation exceeds the limit defined, the pro-
gram is interrupted and an alarm message generated. For a
complete description of the alarms, refer to the Appendix.

VACUUM TEST + Helix Selecting this option, you can run a VACUUM TEST cycle and a Helix Test/B&D cycle in
sequence.
Test/B&D cycle

Vacuum Test Helix / Test Vacuum Test +


B&D Test Helix

To this end, place the test device on the central tray without inserting other material.
Close the door and start the cycle.
The program will execute the two cycles in succession.
Check the results as described in the previous paragraphs.

NOTE
The presence of the Helix Test device does not alter execu-
tion and the result of the Vacuum Test cycle.

H2O TEST Selecting this option, you can test the water quality .

NOTE
THE WATER CONDUCTIVITY IS AUTOMATICALLY MEASURED AT EACH
STERILIZATION OR TEST CYCLE START.

36
DOOR OPENING To open the autoclave door, hold down the button shown in the figure.

CYCLE COMPLETE

00:42

The door opens and stays ajar.

You can now manually open the door.

37
USED WATER DRAIN Open the door and continue as follows:

1. Prepare a basin with a capacity of at least 4 litres in proximity of the sterilizer; place the free end
of the drain tube provided in the basin.
2. Insert the other end of the tube in the female union beneath the chamber inlet (connector on the
right) pushing down until you hear a click.
3. Completely empty out the tank and then press on the metal lever of the union and detach the tube
quick-coupling.

Detaching the pipe

WARNING

MANUAL DO NOT OPEN THE TANK DOORS DURING CYCLE EXECUTION IN ORDER TO
PREVENT HOT WATER LEAKS OR SPURTS.
INTERRUPTION
The cycle can be interrupted manually by the operator at any time by holding down the button
shown in the figure for three seconds.

PRE-HEATING

00:42 >3 S

The command generates the error E999 as the cycle could not be completed correctly.

NOTE
If the cycle is interrupted during certain phases, an auto-
matic cleaning procedure of the internal hydraulic circuit
starts.
For a complete description of the alarms, refer to the Ap-
pendix "Alarm Indications".
WARNING
After manually interrupting a program, DO NOT USE THE LOAD,
AS STERILIZATION IS NOT GUARANTEED.

38
DATA To access the DATA MANAGEMENT section, tap the corresponding icon.
.
MANAGEMENT

TEST

SYSTEM INFORMATION

Selecting SYSTEM INFO, all the information relating to the sterilizer settings is displayed.

System information Print management Cycle download

System information
FW version:
Autoclave code:
Serial number:
Language:
St-by mode:
Print:
H2O filling:
No. of cycles: / no. of complete cycles:

39
PRINT MANAGEMENT

To set the parameters, select the button as shown below:

System inform. Print manag. Cycle download

Print management PRINT LABELS


Tap the button to
PRINT
print the labels
EXTENDED
bearing the cycle
REPORT
data.
Tap the button to
print the summary
cycle report at REPORT
the end of the
process.

PRINT print last


REPORT cycle
Tap the button to print Tap the button to
the summary cycle print the data of the
report at the end of the last cycle set.
process.

At the end of the cycle, when tapping the button indicated, the following page is displayed only if
the printer is connected to the sterilizer and set for label printing (settable from print management).
If not, the sterilizer automatically prints the report.

CYCLE COMPLETE

00:42

Label N.

15
Expiry

30

Select the number of labels to be printed at the end of the cycle and the sterilization expiry date.
Use the arrow buttons to adjust the value.
Tapping the green button (printer), the labels are printed; tapping the red button (crossed out
printer), the labels are not printed.

40
CYCLE DOWNLOAD

You can copy the data relating to the cycles run (stored in the internal memory of the sterilizer)
to a USB key.

To download the sterilization/test cycle files, select the button as shown below.

System inform. Print manag. Cycle download

Network config.

Before carrying out the operations, insert the USB key.


NOTE
NOTE: The USB key must be formatted using the FAT32 system file.

If the USB key is not inserted, you are asked to do so.


Cycle download

Insert key…

The sterilization/test cycle files are in PDF


format.

You can select the number of cycles to be


downloaded to the external memory.
If the Last 10 or Last 100 op- Cycle download
tion is selected, the program-
me will prompt to enter the New
number of the last cycle of Last
the interval to download.
Last 10

Cycle download

Download in progress...

NOTE
WHEN A PRESET VALUE IS EXCEEDED, THE SYSTEM WARNS YOU THAT
YOU NEED TO MAKE A BACKUP OF THE DATA CONTAINED IN THE INTERNAL
MEMORY.

WARNING

DO NOT TURN ON THE STERILIZER, IF USB KEY IS INSERTED.

41
ETHERNET

The C-17PLUS, C-22PLUS, C-28PLUS series sterilizers can be connected to a local Ethernet
network using the connector on the rear of the machine.
Using a web browser (Internet Explorer, Chrome, Firefox etc.) from a PC or another device (ta-
blet, smartphone, etc.) connected to the local network, you can, if you know the TCP-IP number
assigned to the sterilizer, query it to check the operating status. From the sterilizer web page you
can also download the sterilization reports of the cycles executed in order to consult or store them.

For network configuration, the sterilizer supports the DHCP protocol.


DHCP (Dynamic Host Configuration Protocol) is a TCP-IP protocol that allows a device to dialo-
gue with a dedicated server and automatically receive the configuration data necessary to cor-
rectly communicate on the network.

In small networks, the DHCP server functions are very often integrated in the router connected
to the Internet.
For correct configuration of the sterilizer, five types of use are described below:
1) Connection to a local network with DHCP server and sterilizer in automatic configuration.
2) Connection to a local network with DHCP server and sterilizer configured with static IP.
3) Connection to a local network manually configured with “static” IPs.
4) Direct connection via Ethernet cable between a sterilizer and a PC.
5) “Virtual point-to-point” connection between a sterilizer and a PC that uses the automatic DHCP
configuration in a local network.

Local Ethernet network configurations

To set the parameters, select the following option:

System inform. Print manag. Cycle download

Network config.

42
1) Connection to a local network with DHCP server and sterilizer in au-
tomatic configuration

System inform. Print manag. Cycle download

Network config.

Connect the sterilizer to the local Ethernet network using a network cable.
View the Ethernet configuration page.

Ethernet configuration

123 . 567 . 789 . 012


DHCP
IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

Check that automatic DHCP configuration is selected .


With this selection, all the numerical fields on the page are disabled (they turn grey).
With this setting, each time the sterilizer is turned on, it asks the network DHCP server for its
configuration using the DHCP protocol.
Based on the DHCP server configuration, the number assigned may vary each time the sterilizer
is turned on.
The TCP-IP number assigned to the sterilizer appears on the sky-blue bar at the top of the first
page (Home).
Type the number read on the sterilizer in the address field of the web browser.

43
The program will display the web page:

(in the example, the web page address is http://10.20.8.115)

Normally, you can set the DHCP server so that the same IP number is always assigned to a given
device or assign the same number to a certain device for a set period of time. For these settings,
consult the instruction manuals of your local network DHCP server or Internet router.
For these settings, you need to know the MAC address of the sterilizer, which is shown at the
bottom left of the Ethernet configuration page.

Ethernet configuration

123 . 567 . 789 . 012


DHCP
IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

2) Connection to a local network with DHCP server and sterilizer


configured with static IP.
To avoid the inconvenience of having to frequently check the TCP-IP number dynamically
assigned by a DHCP server, you can manually assign a fixed number belonging to the dynamic
numbering of the local network.
However, to prevent conflicts, it is essential that you:
- Configure the DHCP server so that it does not assign the chosen number to other devices.
or
- Statically assign a number to the sterilizer outside the range assigned by the DHCP server.
For the information necessary for a correct configuration, check the local network DHCP server
settings.
To assign a static IP address to the sterilizer:
Access the Data Management menu.
View the Ethernet configuration page.
Check that automatic DHCP configuration is selected.
With this selection, all the numerical fields on the page are disabled (they turn grey).

Ethernet configuration

123 . 567 . 789 . 012


DHCP
IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

44
Read the first three numbers of the local network numbering; in the example shown above, the
first three numbers are:
10.20.8.xxx.
Note: Alternatively, in Windows systems you can use the IPCONFIG command from a "Command
prompt" window (accessible from Programs -> Accessories) to read the local network configura-
tion.
At this point, you need to statically set the new number as follows:

1) Select manual configuration .


2) Set the values read (e.g. 10.20.8) in the first three address fields.
3) Assign the chosen number to the last value, for example 222 (outside the range automatically
assigned and do not use the numbers 0 and 255).
4) Check that the Subnet Mask field is set to 255.255.255.0
5) The Gateway address is not important for communications on the network (set 0.0.0.0).
The complete IP address (in this example) will therefore be: 10.20.8.222.
To connect to the sterilizer, enter the new number in the web browser address field as described
above (http://10.20.8.222).
The program will display the sterilizer web page.

3) Connection to a local network with DHCP server manually configured


with “static” IPs.
If the local network is configured in static mode, you need to assign the IP number as follows:
Access the Data Management menu.
View the Ethernet configuration page.

System inform. Print manag. Cycle download

Network config.

Check that manual configuration is selected .


Normally, static networks (like many small or domestic networks) have a range of addresses se-
lected from so-called “masked” networks, for example, 192.168.0.xxx or 192.168.1.xxx.
For correct configuration, all you need to do is assign a number belonging to the local network
(first three values) and the last number must not be used by another device. ). In Windows sy-
stems you can use the IPCONFIG command from a "Command prompt" window (accessible from
Programs -> Accessories) to read the local network numbering.
To check the numbers already assigned to a local network, there are programs that scan the
devices present in the network (IP scan).
The sterilizer by default suggests 192.168.1.100 as its IP address.
Adapt the static address of the sterilizer to your network.
In any event, you need to assign correctly the number 255.255.255.0 to the Subnet Mask; the
Gateway address is not important for communications on the network (set 0.0.0.0).

Ethernet configuration

123 . 567 . 789 . 012


DHCP
IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

45
For the PC to be able to connect, it should have a configuration similar to that shown below (the
example refers to Windows 7):

The configuration panel can be accessed via Properties of the network card.

4) Direct connection via Ethernet cable between a sterilizer and a PC.


You can directly connect a PC (e.g. notebook) and a sterilizer via an Ethernet cable without both
having to be connected to a local network.
To make the connection, the PC and the sterilizer need to be configured in static mode, as de-
scribed in the example above, making sure that both devices have the same numbering in the first
three fields (for example: PC 192.168.1.10 - sterilizer 192.168.1.100).
Access the Data Management menu.
View the Ethernet configuration page.

System inform. Print manag. Cycle download

Network config.

Check that manual configuration is selected .

46
The sterilizer by default suggests 192.168.1.100 as its IP address.
Do not use the numbers 0 and 255 for the last address field.
Configure the PC as shown below:

5) “Virtual point-to-point” connection between a sterilizer and a PC that


uses the automatic DHCP configuration in a local network.
You can configure a “static” connection between the sterilizer and a PC that already uses DHCP
for its operations on the local network.
To do this, the sterilizer needs to be configured in “static” mode.
Access the Data Management menu.
View the Ethernet configuration page.

System inform. Print manag. Cycle download

Network config.

Check that manual configuration is selected .

Ethernet configuration

123 . 567 . 789 . 012


DHCP
IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

The sterilizer by default suggests 192.168.1.100 as its IP address.


Leave the network configuration already set on the PC and add a new static network with the
numbering 192.168.1.xxx.
To do this, from the network properties panel:

47
Select the option relating to the properties of the TCP/IP protocol.

Select the Alternative Configuration tab.

In the panel, set “Configured by user” and assign the IP address and Subnet Mask as indicated.
(the example refers to Windows 7).

48
WIFI

For WIFI configuration, follow the instructions given above for Ethernet network configuration.
Select the option as shown below:

System inform. Print manag. Cycle download

WIFI configuration

123 . 567 . 789 . 012


IP Adress
123 . 567 . 789 . 012

123 567 789 012


. . .
MAC:0004A39C7CF1

Correctly configure the network by entering the


WIFI network name (SSID) and the network password.

WIFI configuration

SSID
Password

49
APPendix – Technical Characteristics
SUMMARY TABLE

Device Steam Sterilizer


Classification (according to the Directive C-17PLUS C-22PLUS C-28PLUS
93/42/EEC and subsequent changes)
Model II b

Cefla sc
Manufacturer Via Selice Prov.le 23/a
40026 Imola (BO) - Italy
220/240 V~ 50 Hz
Power supply voltage 220/230 V~ 60 Hz
120 V~ 60 Hz
Mains fuses
F 15A 250V
(6.3 x 32 mm)
On-board fuses
F1: T3.15A 250V (primary transformer)
(5 x 20 mm)
2300 W
Nominal power
1440 W (120 V~ 60 Hz)
Insulation class Class I

Installation category Cat. II

Environment of use Internal use

Sound power level (A weighted) < 65 db(A)

Temperature: +15°C ÷ +35°C


Environmental operating conditions Relative humidity: max 80%, non-condensing
Altitude: max 3000 m (a.s.l.)
External dimensions (HxWxD)
500 x 480 x 600 mm
(excluding rear connections)

Net weight: about 47 kg about 55 kg about 58 kg


empty about 49 kg about 57 kg about 60 kg
empty with trays and supporti
empty, with trays and supports and water
about 53 kg about 61 kg about 64 kg
at MAX level

Sterilization chamber dimensions


250 x 350 mm 250 x 450 mm 280 x 450 mm
(Ø x D)

Sterilization chamber total volume about 17 l (0.017 m3) about 22 l (0.022 m3) about 28 l (0.028 m3)

Sterilization chamber useful volume


about 10 l (0.010 m3) about 13 l (0.013 m3) about 19 l (0.019 m3)
(with tray supports inserted)
Distilled water tank capacity about 5,5 l (water at MAX level)
(supply) about 1 l (water at MIN level)

Sterilization programs 5 standard programs + 1 user-defined program


Helix/BD Test
Test programs Vacuum Test
Vacuum Test+Helix/BD Test
Preheating time
about 10 min
(from cold)

USB connection requires memories formatted with the FAT32 file system

Printer connection RS232 serial (printer cable length max 2.5 m)

Ethernet connection RJ45 (cable length max 29m)

Bacteriological filter Porosity: 0,2 mm


(PTFE filtering element) Connection: male 1/8” NPT connector

50
Safety Devices

The sterilizer is equipped with the following safety devices for which we provide a brief description of their function:

–– Mains fuses (see summary table data)


Protection inside the device against a fault in the heating elements.
Action: cuts the electricity.

–– Fuses protecting the electronic circuits (see summary table data)


Protection against a fault in the primary transformer circuit and low voltage uses.
Action: cuts power to one or more low-voltage circuits.

–– Thermal circuit breakers on the mains voltage windings


Protection against overheating of the vacuum pump motor and the primary transformer windings.
Action: temporary cut-off (until cooling) of the winding.

–– Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.

–– Steam generator manual rearm safety thermostat


Protection against steam generator overheating.
Action: cut-off of the electricity to the steam generator.

–– Heating element manual rearm safety thermostat


Protection against overheating of the heating elements of the container under pressure.
Action: cut-off of the electricity to the chamber heating element.

–– Door position safety microswitch


Confirmation of the correct closing position of the door of the container under pressure.
Action: signals wrong door position.

–– Mechanized door lock mechanism with electromechanical protection (pressure switch)


Protection against accidental opening of the door (even in a blackout).
Action: prevents accidental opening of the door during a program.

–– Door lock mechanism safety microswitch


Confirmation of the correct closing of the door lock.
Action: signaling the failure or incorrect operation of the door lock mechanism.

–– Self-leveling plumbing system


Plumbing system structure for the spontaneous leveling of the pressure in the case of a manual interruption of the cycle,
alarm or blackout.
Action: automatic restoration of atmospheric pressure in the sterilization chamber.

–– Integrated system for evaluating the sterilization process


Continuous verification of the sterilization process parameters entirely managed by microprocessor.
Action: immediate interruption of the program (in case of anomaly) and generation of alarms.

–– Monitoring of the sterilizer’s operation


Real-time oversight of all significant parameters when the machine is powered.
Action: generation of alarm messages (in the case of anomaly) with possible interruption of the cycle.

51
Water supply characteristics

VALUES IN
DESCRIPTION WATER SUPPLY VALUES
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/l

SILICON OXIDE SiO2 < 1 mg/l < 0.1 mg/l

IRON < 0.2 mg/l < 0.1 mg/l

CADMIUM < 0.005 mg/l < 0.005 mg/l

LEAD < 0.05 mg/l < 0.05 mg/l


HEAVY METAL RESIDUES
< 0.1 mg/l < 0.1 mg/l
(except iron, cadmium and lead)
CHLORINES < 2 mg/l < 0.1 mg/l

PHOSPHATES < 0.5 mg/l < 0.1 mg/l

CONDUCTIVITY AT 20 °C < 15 ms/cm < 3 ms/cm

pH VALUE 5-7 5-7


colorless, transparent, colorless, transparent,
APPEARANCE
without sediments without sediments
HARDNESS < 0.02 mmol/l < 0.02 mmol/l

NOTE
WHEN PURCHASING DISTILLED WATER, ALWAYS CHECK THAT THE QUALITY AND
CHARACTERISTICS DECLARED BY THE PRODUCER ARE COMPATIBLE WITH THOSE
SHOWN IN THE TABLE.

WARNING
THE USE OF WATER FOR GENERATING STEAM CONTAINING CONTAMINANTS IN
LEVELS EXCEEDING THOSE SHOWN IN THE TABLE WILL SIGNIFICANTLY SHORTEN THE
STERILIZER’S LIFE.
IN ADDITION, THIS MAY INCREASE THE OXIDATION OF MORE SENSITIVE MATERIALS AND
INCREASE LIME RESIDUES ON THE GENERATOR, BOILER, INTERNAL SUPPORTS AND
INSTRUMENTS.

52
APPENDIX – PROGRAMS

INTRODUCTION
The steam sterilizer is appropriate for almost all materials and instruments, so long as they are able to tolerate, without damage, a
minimum temperature of 121 °C (otherwise, you will need to use other low-temperature sterilization systems).

The following material can normally be sterilized with steam:

– Stainless steel surgical/generic instruments;


– Carbon steel surgical/generic instruments;
– Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (counter-angles, tooth
scalers);
– Glass articles:
– Mineral-based articles;
– Articles made of heat-resistant plastic;
– Articles made of heat-resistant rubber;
– Heat-resistant textiles;
– Medication materials (gauze, pads, etc.);
– Other generic material suitable for autoclave treatment.

NOTE
DEPENDING ON THE CONFORMATION OF THE MATERIAL (SOLID, HOLLOW OR POROUS),
ANY PACKAGING (PAPER/PLASTIC ENVELOPE, STERILIZATION PAPER, CONTAINER,
MUSLIN NAPKIN, ETC.) AND ITS HEAT-RESISTANCE, IT IS INDISPENSABLE THAT YOU
CHOOSE THE APPROPRIATE PROGRAM BY REFERRING TO THE TABLE SHOWN ON THE
NEXT PAGE.

WARNING
THE DEVICE MAY NOT BE USED FOR STERILIZATION OF FLUIDS, LIQUIDS OR
PHARMACEUTICAL PRODUCTS.

53
Program Summary Table – C-17 PLUS
220 V - 240 V~ 50 Hz
220 V - 230 V~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure
CYCLE

(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in
0,60 0,20 0,20
double package
134°C UNIVERSAL 134 2,10 4 B F 30÷33 500 0,75
Solid and hollow mate-
3,00 1,00 0,50
rials in single package

Unwrapped solid and


6.00 1.20 0.25
hollow materials
Solid and hollow in-
struments A" in double 1,50 0,50 0,25
package
Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in For wrapped materials


0,60 0,20 0,20 and instruments (single
double package
134°C PRION 134 2,10 >18 B F 46÷49 550 0,85 and double package), it
Hollow instruments in is advisable to use the
3,00 1,00 0,50
single package 3-tray configuration
Unwrapped solid and
6.00 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 1,50 0,50 0,25
package
Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in
0,60 0,20 0,20
double package
121°C UNIVERSAL 121 1,10 20 B F 45÷48 550 0,75
Unwrapped solid and
6,00 1,20 0,25
hollow materials

Hollow instruments in
3,00 1,00 0,50
single package
Solid and hollow in-
struments in double 1,50 0,50 0,25
package
Unwrapped hollow in-
6,00 1,20 0,50
134°C HOLLOW struments
134 2,10 4 S F 26÷29 500 0,65
UNWRAPPED Unwrapped solid and
6,00 1,20 0,50
hollow materials
Solid and hollow in-
It is advisable to use the
struments "B" in single 3,00 1,00 0,25
134°C SOLID WRAP- 3-tray configuration
134 2,10 4 S S 28÷34 300 0,55 package
PED
Unwrapped solid and
6,00 1,20 0,50
hollow materials
Unwrapped solid instru-
134 2,10 >4 Variable parameters de-
XXX°C USER ments (other load types are
opp. opp. opp. n.d. F/S n.d. n.d. n.d. n.d. n.d. n.d. pending on the settings
(see note) possible depending on the
121 1,10 >20 made
user settings)
Test device only
HELIX/BD TEST 134 2,10 3,5 - F 25 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 18 - - Empty chamber - - -


VACUUM + HELIX/
BD TEST (execut- - - - - - 45 - - - -
able in sequence)

54
Program Summary Table – C-17 PLUS
120 V ~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure
CYCLE

(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in
0,60 0,20 0,20
double package
134°C UNIVERSAL 134 2,10 4 B F 37÷40 500 0,75
Solid and hollow mate-
3,00 1,00 0,50
rials in single package

Unwrapped solid and


6.00 1.20 0.25
hollow materials
Solid and hollow in-
struments A" in double 1,50 0,50 0,25
package
Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in For wrapped materials


0,60 0,20 0,20 and instruments (single
double package
134°C PRION 134 2,10 >18 B F 51÷54 550 0,85 and double package), it
Hollow instruments in is advisable to use the
3,00 1,00 0,50
single package 3-tray configuration
Unwrapped solid and
6.00 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 1,50 0,50 0,25
package
Unwrapped porous
1,00 0,30 0,30
materials

Porous materials in sin-


0,75 0,25 0,25
gle package

Porous materials in
0,60 0,20 0,20
double package
121°C UNIVERSAL 121 1,10 20 B F 50÷53 550 0,75
Unwrapped solid and
6,00 1,20 0,25
hollow materials

Hollow instruments in
3,00 1,00 0,50
single package
Solid and hollow in-
struments in double 1,50 0,50 0,25
package
Unwrapped hollow in-
6,00 1,20 0,50
134°C HOLLOW struments
134 2,10 4 S F 31÷33 500 0,65
UNWRAPPED Unwrapped solid and
6,00 1,20 0,50
hollow materials
Solid and hollow in-
It is advisable to use the
struments "B" in single 3,00 1,00 0,25
134°C SOLID WRAP- 3-tray configuration
134 2,10 4 S S 33÷35 300 0,55 package
PED
Unwrapped solid and
6,00 1,20 0,50
hollow materials
Unwrapped solid instru-
134 2,10 >4 Variable parameters de-
XXX°C USER ments (other load types are
opp. opp. opp. n.d. F/S n.d. n.d. n.d. n.d. n.d. n.d. pending on the settings
(see note) possible depending on the
121 1,10 >20 made
user settings)
Test device only
HELIX/BD TEST 134 2,10 3,5 - F 31 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 18 - - Empty chamber - - -


VACUUM + HELIX/
BD TEST (execut- - - - - - 51 - - - -
able in sequence)

55
Program Summary Table – C-22 PLUS

220 V - 240 V~ 50 Hz
220 V - 230 V~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060)

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure

CYCLE
(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in
0,75 0,25 0,20
double package
134°C UNIVERSAL 134 2,10 4 B F 38÷40 675 0,8
Solid and hollow mate-
4,00 1,25 0,50
rials in single package
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments A in double 2,00 0,60 0,25
package
Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in For wrapped materials
0,75 0,25 0,20 and instruments (single
double package
134°C Prion 134 2,10 >18 B F 55÷58 700 0,9 and double package), it
Hollow instruments in is advisable to use the
4,00 1,25 0,50
single package 3-tray configuration
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 2,00 0,60 0,25
package
Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in
0,75 0,25 0,20
double package
121°C UNIVERSAL 121 1,10 20 B F 53÷56 700 0,8
Hollow instruments in
4,00 1,25 0,50
single package
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 2,00 0,60 0,25
package
Unwrapped hollow in-
7,50 1,50 0,50
134°C HOLLOW UN- struments
121 1,10 20 S F 32÷35 700 0,7
WRAPPED Unwrapped solid and
7,50 1,20 0,50
hollow materials
Solid and hollow in-
struments "B" in single 4,00 1,25 0,25
134°C SOLID It is advisable to use the
134 2,10 4 S S 30÷32 375 0,6 package
WRAPPED Unwrapped solid and 3-tray configuration
7,50 1,20 0,50
hollow materials
Unwrapped solid instru-
134 2,10 >4 Variable parameters de-
XXX°C USER ments (other load types
opp. opp. opp. n.d. F/S n.d. n.d. n.d. n.d. n.d. n.d. pending on the settings
(see note) are possible depending
121 1,10 >20 made
on the user settings)

Test device only


HELIX/BD TEST 134 2,10 3,5 - F 30 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 18 - - Empty chamber - - -

VACUUM + HELIX/BD
TEST (executable in - - - - - 50 - - - - - -
sequence)

56
Program Summary Table – C-22 PLUS

120 V ~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060)

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure

CYCLE
(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in
0,75 0,25 0,20
double package
134°C UNIVERSAL 134 2,10 4 B F 46÷48 675 0,8
Solid and hollow mate-
4,00 1,25 0,50
rials in single package
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments A in double 2,00 0,60 0,25
package
Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in For wrapped materials
0,75 0,25 0,20 and instruments (single
double package
134°C Prion 134 2,10 >18 B F 60÷62 700 0,9 and double package), it
Hollow instruments in is advisable to use the
4,00 1,25 0,50
single package 3-tray configuration
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 2,00 0,60 0,25
package
Unwrapped porous
1,25 0,40 0,30
materials
Porous materials in sin-
1,00 0,30 0,25
gle package
Porous materials in
0,75 0,25 0,20
double package
121°C UNIVERSAL 121 1,10 20 B F 61÷63 700 0,8
Hollow instruments in
4,00 1,25 0,50
single package
Unwrapped solid and
7,50 1,20 0,25
hollow materials
Solid and hollow in-
struments in double 2,00 0,60 0,25
package
Unwrapped hollow in-
7,50 1,50 0,50
134°C HOLLOW UN- struments
134 1,10 20 S F 40÷42 700 0,7
WRAPPED Unwrapped solid and
7,50 1,20 0,50
hollow materials
Solid and hollow in-
struments "B" in single 4,00 1,25 0,25
134°C SOLID It is advisable to use the
134 2,10 4 S S 38÷40 375 0,6 package
WRAPPED Unwrapped solid and 3-tray configuration
7,50 1,20 0,50
hollow materials
Unwrapped solid instru-
134 2,10 >4 Variable parameters de-
XXX°C USER ments (other load types
opp. opp. opp. n.d. F/S n.d. n.d. n.d. n.d. n.d. n.d. pending on the settings
(see note) are possible depending
121 1,10 >20 made
on the user settings)

Test device only


HELIX/BD TEST 134 2,10 3,5 - F 37 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 18 - - Empty chamber - - -

VACUUM + HELIX/BD
TEST (executable in - - - - - 57 - - - - - -
sequence)

57
Program Summary Table – C-28 PLUS
220 V - 240 V~ 50 Hz
220 V - 230 V~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060)

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure
CYCLE

(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous ma-


1.50 0.50 0.50
terials
Porous materials in sin-
1.25 0.35 0.35
gle package
Porous materials in dou-
0.90 0.30 0.30
ble package
134°C UNIVERSAL 134 2.10 4 B F 54÷47 859 0.8
Solid and hollow mate-
5.00 1.50 0.75
rials in single package
Unwrapped solid and
9.00 1.40 0.25
hollow materials
Solid and hollow instru-
ments "A" in double 2.50 0.70 0.25
package
Unwrapped porous ma-
1.50 0.50 0.50
terials

Porous materials in sin-


1.25 0.35 0.35
gle package
For wrapped ma-
Porous materials in dou- terials and instru-
0.90 0.30 0.30
ble package ments (single and
134°C Prion 134 2.10 >18 B F 68÷71 890 1.0 double package), it
Hollow instruments in is advisable to use
5.00 1.50 0.75
single package the 3-tray configu-
Unwrapped solid and ration
9.00 1.40 0.25
hollow materials
Solid and hollow instru-
2.50 0.70 0.25
ments in double package

Unwrapped porous ma-


1.50 0.50 0.50
terials

Porous materials in sin-


1.25 0.35 0.35
gle package

Porous materials in dou-


0.90 0.30 0.30
ble package
121°C UNIVERSAL 121 1.10 20 B F 66÷69 890 0.9
Unwrapped solid and
9.00 1.50 0.75
hollow materials

Hollow instruments in
5.00 1.40 0.25
single package

Solid and hollow instru-


2.50 0.70 0.25
ments in double package

Unwrapped hollow in-


9.00 1.20 0.50
134°C HOLLOW struments
121 1.10 20 S F 43÷46 890 0.8
UNWRAPPED Unwrapped solid and
9.00 1.20 0.50
hollow materials

Solid instruments in sin-


5.00 1.00 0.25 It is advisable to
134°C SOLID WRAP- gle package
134 2.10 4 S S 40÷43 477 0.7 use the 3-tray con-
PED
Unwrapped solid and figuration
9.00 1.20 0.50
hollow materials
134 2.10 >4 Variable parame-
XXX°C USER Unwrapped solid instru-
or or or. n.a. F/S n.a. n.a. n.a. n.a. n.a. n.a. ters depending on
(see note) ments
121 1.10 >20 the settings made

Test device only


HELIX/BD TEST 134 2.10 3.5 - F 40 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 20 - - Empty chamber - - -

VACUUM + HELIX/BD
TEST (executable in - - - - 62 - - - -
sequence)

58
Program Summary Table – C-28 PLUS
120 V ~ 60 Hz

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS

Average H2O consumption


(F=fractionated; S=Single)

(average load ÷ max load)


Cycle time (EN 13060)

MAX TOTAL WEIGHT


Average energy con-
Total cycle time

FOR TRAY (kg)


Retention time

FOR ITEM (kg)


MAX WEIGHT

MAX WEIGHT
DESCRIPTION
Temperature

(kWh /cycle)
Pre-vacuum

(ml /cycle)
NOTES

sumption
Pressure
CYCLE

(min)
(bar)

(kg)
(°C)

TYPE

Unwrapped porous ma-


1.50 0.50 0.50
terials
Porous materials in sin-
1.25 0.35 0.35
gle package
Porous materials in dou-
0.90 0.30 0.30
ble package
134°C UNIVERSAL 134 2.10 4 B F 58÷61 859 0.8
Solid and hollow mate-
5.00 1.50 0.75
rials in single package
Unwrapped solid and
9.00 1.40 0.25
hollow materials
Solid and hollow instru-
ments "A" in double 2.50 0.70 0.25
package
Unwrapped porous ma-
1.50 0.50 0.50
terials

Porous materials in sin-


1.25 0.35 0.35
gle package
For wrapped ma-
Porous materials in dou- terials and instru-
0.90 0.30 0.30
ble package ments (single and
134°C Prion 134 2.10 >18 B F 72÷75 890 1.0 double package), it
Hollow instruments in is advisable to use
5.00 1.50 0.75
single package the 3-tray configu-
Unwrapped solid and ration
9.00 1.40 0.25
hollow materials
Solid and hollow instru-
2.50 0.70 0.25
ments in double package

Unwrapped porous ma-


1.50 0.50 0.50
terials

Porous materials in sin-


1.25 0.35 0.35
gle package

Porous materials in dou-


0.90 0.30 0.30
ble package
121°C UNIVERSAL 121 1.10 20 B F 70÷73 890 0.9
Unwrapped solid and
9,00 1.50 0.75
hollow materials

Hollow instruments in
5.00 1.40 0.25
single package

Solid and hollow instru-


2.50 0.70 0.25
ments in double package

Unwrapped hollow in-


9.00 1.20 0.50
134°C HOLLOW struments
121 1.10 20 S F 47÷50 890 0.8
UNWRAPPED Unwrapped solid and
9.00 1.20 0.50
hollow materials

Solid instruments in sin-


5.00 1.00 0.25 It is advisable to
134°C SOLID WRAP- gle package
134 2.10 4 S S 43÷46 477 0.7 use the 3-tray con-
PED
Unwrapped solid and figuration
9.00 1.20 0.50
hollow materials
134 2.10 >4 Variable parame-
XXX°C USER Unwrapped solid instru-
or or or. n.a. F/S n.a. n.a. n.a. n.a. n.a. n.a. ters depending on
(see note) ments
121 1.10 >20 the settings made

Test device only


HELIX/BD TEST 134 2.10 3.5 - F 44 - - - - -
(without another load)

VACUUM TEST - -0,80 - - - 20 - - Empty chamber - - -

VACUUM + HELIX/BD
TEST (executable in - - - - 66 - - - -
sequence)

59
STERILIZATION PROGRAM DIAGRAM

Pressure (bar)
PROGRAM
134°C - UNIVERSAL
PROCESS
134°C - 4' 00''
2.10
2.00 PROGRAM
134°C - PRION
134°C - 18' 00''

1.00

Time (min)
0.00

-0.80

PRE-VACUUM LONG DRYING

Pressure (bar)
PROGRAM
121°C - UNIVERSAL
121°C - 20'00''

PROCESS
1.10
1.00

Time (min)
0.00

-0.80

LONG DRYING
FRACTIONATED PRE-VACUUM

60
Pressure (bar) PROGRAM
134°C - HOLLOW
PROCESS 134°C - 4'00''
2.10
2.00

1.00

Time (min)
0.00

-0.80

-1.00
FRACTIONATED PRE-VACUUM SHORT DRYING

Pressure (bar)
PROGRAM
PROCESS 134°C - WRAPPED
134°C - 4'00''
2.10
2.00

1.00

Time (min)
0.00

-1.00
ONE SHOT PRE-VACUUM LONG DRYING

61
DIAGRAMS of THE TEST PROGRAMMES

Pressure (bar) PROGRAM


BOWIE & DICK TEST
PROCESS 134°C - 3'00''

2.10
2.00

1.00

Time (min)
0.00

0.00
- 1.00 SHORT DRYING
FRACTIONATED PRE-VACUUM

Pressure (bar) PROGRAM


VACUUM TEST (VT)
-0.80 bar

1.00

Intermediate condition for End condition for


the continuation of the test positive test result

0.00 t1 (P2-P1) < (P0-P1) /10 t2 = t1+300 s (P3-P2) < 0.013


0.02 bar t3 = t2+600 s Time (min)

P 0
5 minutes 10
16 minutes
minutes
VACUUM
PHASE

WAITING LEAKAGE

-0.80 P2 P3
P1

62
EXAMPLES OF PRINTED REPORTS
(WITH OPTIONAL PRINTER)

Program printing (standard) Program printing Program printing


HELIX/BD TEST VACUUM TEST
Model Model
S/N S/N
Ver. SW Ver. SW
Counter 00007 Model
Counter 00012
Selection 134 °C SOLID S/N
Selection VACUUM TEST
Temperature 134 °C Ver. SW
Pressure 2.10 bar Counter 00011
Process time 4 min Selection HELIX TEST
Stand‑by LOW CYCLE START 01/02/11
Temperature 134 °C
Pre-vacuum SINGLE 11:37
Pressure 2.10 bar
Drying FAST Process time 3.5 min
Time C bar
CYCLE START 01/02/11
CYCLE START 01/02/11 ----------------------------------------------------------
12:14 16:38
00:00 CS 035.0 +0.00

Time C bar Time C bar


---------------------------------------------------------- 01:39 E1F 037.4 ‑0.80
----------------------------------------------------------
00:01 CS 079.4 +0.00 00:01 CS 076.4 +0.00
02:06 1PV 089.3 -0.89 6:39 E2F 038.4 ‑0.79
02:02 1PV 093.7 -0.80
05:48 ET 135.6 +2.15 04:35 1PP 120.4 +0.99
05:45 2PV 062.5 -0.78 22:39 E3F 042.0 ‑0.79
06:02 SS 135.9 +2.17
07:02 135.6 +2.14 07:02 2PP 120.2 +0.97
08:02 135.5 +2.14 08:15 3PV 061.1 -0.79 23:54 CE 045.5 ‑0.01
09:02 135.4 +2.14 11:00 .. 135.6 +2.15
10:02 SE 135.5 +2.15 11:14 .. 136.0 +2.17 CYCLE END 01/02/11
10:37 DS 104.1 +0.00 12:14 135.6 +2.14 12:01
11:41 SPD 047.5 ‑0.90 13:14 135.6 +2.15
16:08 DE 047.6 ‑0.84 VACUUM TEST: POSITIVE
14:14 135.5 +2.14
17:12 CE 084.6 ‑0.04
14:45 .. 135.4 +2.14
OPERATOR
06:32 MAX 136.0 15:20 .. 111.5 +0.00
..................................
09:59 MIN 135.4 16:34 … 047.8 -0.89
18:21 … 059.5 -0.86
Drying PuIses 01 19:21 .. 075.4 ‑0.50
CYCLE END 01/02/11 20:06 CE 078.7 ‑0.04
12:36
12:33 MAX 136.0
STERILIZATION: POSITIVE 14:44 MIN 135.4
OPERATOR Drying pulses 01
.................................. CYCLE END 01/02/11
----------------------------------------------------------
17:01
Model
S/N HELIX TEST COMPLETE
Ver. SW Please attach the indicator hereunder
Counter 00007
Selection 134 °C UNIVERSAL
Temperature 134 °C
Pressure 2.10 bar
Process time 4 min OPERATOR
Stand-by HIGH ..................................
Pre-vacuum FRACTIONATED
Drying STANDARD

CYCLE START 01/02/10


09:52

Time C bar
----------------------------------------------------------
00:01 CS 075.1 ‑0.00
01:57 1PV 047.S ‑0.80
04:53 1PP 120.5 +1.00
07:00 2PV 061.1 ‑0.80
09:15 2PP 120.4 +0.98
11:22 3PV 061.1 ‑0.80
15:04 ET 135.5 +2.15
15:19 SS 135.9 +2.17
16:19 135.4 +2.14
17:18 135.5 +2.15
18:19 135.4 +2.14
19:19 SE 135.5 +2.15
19:53 DS 104.4 +0.00
20:57 SPD 048.4 ‑0.90
26:55 EPD 094.9 ‑0.86
29:15 DE 112.6 ‑0.47
29:43 CE 115.8 ‑0.04

16:20 MAX 135.9


18:11 MIN 135.4

Drying Pulses 05
CYCLE END 01/02/11
10:28

STERILIZATION: POSITIVE

OPERATOR

..................................

----------------------------------------------------------

63
APPENDIX – MAINTENANCE
In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the
device’s entire life.

Introduction For better quality maintenance, supplement ordinary checks with regular periodic examinations
by the service department (see Appendix).

It is also fundamental to perform a periodic sterilizer validation, i.e., a check of the


thermodynamic parameters of the process, comparing them with the reference values
provided with suitably calibrated instruments. In this regard, see the paragraph, “Periodic
Sterilizer’s Validation”, further below in this Appendix.

The ordinary maintenance described below consists in easy manual operations and preventive
interventions involving simple instruments.

WARNING
In the event of the replacement of the device’s components
or parts, request and/or use ORIGINAL REPLACEMENT PARTS
ONLY.

Ordinary The table summarizes the maintenance required to keep the sterilizer operating at peak
efficiency. In the case of very intense use, we recommend shortening maintenance intervals:
Maintenance
Program
Clean the gasket on the porthole
DAILY
Clean external surfaces

Clean the sterilization chamber and relative accessories


WEEKLY
Disinfect external surfaces

Clean the internal (and external - if installed) distilled water


tank
MONTHLY
Safety valve maintenance
Clean (or replace) the drain filter

ANNUALLY Validate sterilizer (see dedicated paragraph)

Scheduled Maintenance The steriliser periodically reminds the user about necessary “routine” maintenance opera-
Messages tions that must be carried out in order to ensure the proper operation of the device.

Message
Clean the dust filter
00:42 Replace the bacteriological
filter

OK

Press the OK button to confirm that the required maintenance operation has been comple-
ted.

Press the button to postpone the operation.


In this case, the warning message will reappear the next time the sterilizer is used.

64
WARNING MESSAGE
BOILER FILTER CLEANING
DOOR LOCK LUBRICATION
DUST FILTER CLEANING
BACTERIOLOGICAL FILTER
REPLACEMENT
WATER TANK CLEANING
BOILER GASKET REPLACEMENT
GENERAL SERVICE
NOTE
TO ACHIEVE THE BEST PERFORMANCE OF THE DEVICE, REGULAR MAIN-
TENANCE MUST BE CARRIED OUT ON A REGULAR BASIS.
PERIODICALLY A MESSAGE WILL BE DISPLAYED REQUESTING THAT THE
ABOVE MAINTENANCE CHECKS BE PERFORMED.
FOR FURTHER INFORMATION OR IN CASE OF DOUBT, CONTACT THE
TECHNICAL SERVICE: IF THEY HAVE PERFORMED REGULAR MAINTE-
NANCE ON THE DEVICE, THE TECHNICIAN MIGHT HAVE ALREADY CAR-
RIED OUT SOME OF THESE OPERATIONS (EXAMPLE: BACTERIOLOGICAL
FILTER OR GASKET REPLACEMENT).

Keep the following general warnings in mind:

–– Do not wash the sterilizer with direct jets of water, either under pressure or sprinkled. Seepage into
electrical and electronic components could damage the functioning of the device or its internal parts,
even irreparably;
–– Do not use abrasive cloths, metal brushes (or other aggressive materials) or metal-cleaning
products, whether solids or liquids, to clean the device or sterilization chamber;
–– Do not use chemical products or disinfectants to clean the sterilization chamber. In fact, these
products can damage the sterilization chamber, even irreparably;
–– Do not allow lime residue or other substances to accumulate in the sterilization chamber or on the
door and its gasket, but periodically remove them. In fact, they can damage these parts over time
in addition to compromising the operation of the components installed along the plumbing circuit.

NOTE
THE FORMATION OF WHITE SPOTS ON THE BASE OF THE INTERNAL
WALLS OF THE STERILIZATION CHAMBER MEANS THAT YOU ARE USING
LOW-QUALITY DEMINERALIZED WATER.

Sterilization cycle When the number of cycles recorded in the internal memory and not yet downloaded via the USB port
backup (memory key) exceeds the preset value (100 cycles), the system informs the user that a backup needs
to be made.
Nicola*
Warning

Run cycle backup


Nicola*
Marco OK

Press the OK button to confirm that the required maintenance operation has been completed.

Press the button to postpone the operation.


In this case, the warning message will reappear the next time the sterilizer is used.

65
DANGER
BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT THE
POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET.

WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER


OF THE EQUIPMENT POWER SUPPLY LINE.

IF THE EXTERNAL BREAKER IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE
TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE
EXTERNAL BREAKER AFTER TURNING IT OFF.

Maintenance Let’s now look at the various operations to be carried out.


Description

Clean gasket and porthole To eliminate any traces of limestone, clean the chamber gasket and the door window with a clean
cotton cloth that has been soaked in a weak solution of water and vinegar (or a similar product;
verify the contents on the label before using).

Dry the surfaces and remove any residues before using the device.

Clean external surfaces Clean all the external parts using a clean cotton cloth dampened with water and, possibly, the
addition of a neutral detergent.
Dry the surfaces and remove any residue before using the device.

Clean sterilization chamber Clean the sterilization chamber, support and trays (and internal surfaces in general) with a clean
and accessories cotton cloth soaked in water and, possibly, the addition of a small amount of neutral detergent.
Carefully rinse with distilled water, taking care not to leave any type of residue in the chamber or
on accessories.

NOTE
Do not use pointed or sharp tools to remove scale from the
sterilization chamber. Should there be evident deposits, im-
mediately check the quality of the distilled water used (see
Appendix Technical Features).

Disinfect external surfaces For the occasional disinfection of the external surfaces, you can use either denatured alcohol or
detergents with a minimum percentage of sodium hypochlorite (or equivalent).

66
Boiler filter cleaning With use it is likely that various residues accumulate in the filter and with time obstruct the lower
drain duct.
To clean the filter, open the sterilizer door and remove the cap using a coin or another suitable
tool.

Remove the filter from its holder and thoroughly clean it under a jet of running water, if necessary
using a sharp tool to remove any large foreign bodies (if possible use a jet of compressed air).
If it is impossible to recover the filter, replace it with a new one.
Refit everything operating in reverse order from removal and making sure that you screw the
union (2) on in such a way that the drain holes (4) are positioned at the level of the boiler wall.

NOTE
Properly fit the filter in its housing; fitting it only partially
may damage the component.

Door lock lubrication Using a clean cloth, remove any residues from the bushing and the screw.
Lubricate the inside of the bushing on the sterilizer door with a film of the silicon-based grease
provided (as shown in the figure).
NOTE
PUT ON SINGLE-USE GLOVES BEFORE APPLICATION.
ESSENTIALLY, THE LUBRICANT IS NOT IRRITANT TO THE SKIN; NEVER-
THELESS, IT MAY CAUSE UNPLEASANT EFFECTS IF IT ACCIDENTALLY
COMES INTO CONTACT WITH THE EYES.
IN CASE OF CONTACT WITH THE EYES, RINSE WITH ABUNDANT WATER.

67
Dust filter cleaning Remove the dust filter (A) from the lower part of the autoclave, thoroughly rinse it with water and
dry it before refitting it.

Replace the bacteriological When filter maintenance is due according to the maintenance schedule or every time you notice
filter visible clogging of the filter (indicated by the filter markedly turning grey), unscrew the bacterio-
logical filter (B) from its holder and replace it with a new one, screwing it fully down on the union.

NOTE
A spare bacteriological filter is provided with the sterilizer.
If you need additional parts of this component (the only re-
placeable by the user) Refer to Appendix technical assistan-
ce.

Water tank cleaning Empty the tanks (C) containing the autoclave feedwater and wastewater, remove any deposits
around the filter (D) on the bottom of the tank (see figure).
After removing and cleaning the filter, wipe the inside of the tanks with a dry cloth and clean
thoroughly.

C C

When cleaning is complete, refit the filter in the tank.

NOTE
DO NOT USE CLEANING PRODUCTS INSIDE THE TANK. USE A DRY CLOTH
ONLY.

Boiler gasket replacement It is advisable to have the boiler gasket replaced by an authorised technician, therefore, contact
Technical Service (see APPENDIX – TECHNICAL SERVICE).

68
Periodic sterilizer As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in
validation performance and the effectiveness of components along its lifespan, in a period of time dependent
on its frequency of use.
To guarantee the safety of the process over time, it is periodically (possibly annually) necessary
to verify the thermodynamic process parameters (pressure and temperature), to check if they
continue to remain within allowed limits or not.
The requalification of the sterilizer’s performance is the responsibility of the user of the product.
The reference European standards EN 17665 (Sterilization of the medical devices - Method for
the validation and systematic control of the steam sterilization) and EN 556 (Sterilization of the
medical devices – Requirements for the medical devices marked with “STERILE” indication)
supply an effective guide tool for carrying out the verifications on the steam sterilizers.

Since, in addition to specific experience and training, these controls require the use of special
equipment (high-precision sensors and probes, data loggers, dedicated software, etc.) suitably
verified and calibrated, it is necessary to contact a company specializing in these activities.

Customer support department (see Appendix is available to provide any information relative to
the periodic validation of steam sterilizers.

DISPOSAL at In accordance with Directives 2002/95/ EC, 2002/96/ EC and 2003/108/ EC, regarding the
reduction in use of dangerous substances in electrical and electronic equipment, as well as waste
end-of-life
disposal, such equipment may not be disposed of as normal urban waste and must be separated
accordingly. When purchasing a new, equivalent piece of equipment, the old piece of equipment
that has reached its end-of-life must be handed over to the reseller for proper disposal. As regards
reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer
carries out the functions defined in the individual national legislations.
The proper collection and separation of such equipment for recycling, treatment and disposal helps
avoid any possible negative effects on the environment and health and facilitates the recycling of
the materials of which the equipment is made. The crossed out rubbish can symbol indicates that
the product, at the end-of-life, must be collected separately from other types of waste.

WARNING!
Improper disposal of the product results in the application of sanctions which are defined
by individual national laws.

69
APPENDIX – GENERAL PROBLEMS
Introduction

If you run into a problem or alarm while using the device, you should not be immediately concerned.
It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a
blackout), or incorrect use.

In any case, it is important to first identify the cause of the anomaly and then take suitable corrective action, either autonomously or
with the help of the Technical Support Department (see Appendix Z).

For this purpose, below, we provide instructions for diagnosing and resolving general problems, in addition to a precise description of
the alarm codes, their meaning and their solution.

Analysis and resolution of problems


If your sterilizer is not working correctly, please make the following checks before calling the Technical Support Department:

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

The power cord is not plugged-in. Plug it in.

Check the cause of the lack of voltage at and


There is no voltage at the socket.
socket and fix it.

The sterilizer does not power-on. The main switch and/or differential
Turn the switch ON.
switch are OFF.
Replace with good fuses of equal nominal
value.
The mains fuses are blown.
(See the Summary Table in Appendix
Technical Characteristics).

Wait for the sterilizer to reach the proper


operating conditions for starting the program.
After pressing START, the sterilization
The device is preheating. NOTE: Under normal conditions, the
cycle does not start.
average preheating time is about
10-15 minutes.

Locking ring loosened. Repeat the sterilization cycle. If the problem


The safety valve has intervened. Presence of anomalous overpressure in persists, contact Technical Service (see Ap-
the chamber. pendix).

Check the seal of the unions; if necessary,


refit paying greater attention.
Automatic water filling system tube (op-
tional) not properly connected. Check that the tubes are completely fitted on
the unions; check that the hose clamps are
There is water on the support surface of fitted.
the sterilizer.
At the end of the cycle, clean the gasket and
porthole of the container under pressure.
Steam leaks from the gasket.
Check if the gasket is damaged.
Run another cycle and check the situation.

70
PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
Check the quantity of material sterilized
and make sure that it does not exceed
Excessive quantity of material inside the the maximum allowed quantity,
sterilization chamber. depending on the type of load.
(See the Summary Table in Appendix
Technical Characteristics”).
Position the material, and especially
wrapped material, according to the
Material not correctly positioned. instructions.
Excessive humidity on the material (See the Chapter, “Preparing the
and/or instruments at the end of the Material”).
program.
Select the appropriate sterilization
program for the type of material to be
Wrong sterilization program selection treated.
(See the Summary Table in Appendix
“Programs”).

Drain filter of the sterilization chamber Clean or replace the drain filter
obstructed. (See Appendix “Maintenance”).

Check the quality of the instruments


Quality of the instruments is not with the problem, checking whether the
adequate. material they are made of can tolerate
steam sterilization.

Empty the tank and fill it with high-


quality distilled water.
Quality of the distilled water not
adequate. (See the Water Supply Characteristics
in Appendix “Technical
Characteristics”).
Traces of oxidation or spots on
instruments Carefully clean the material before
Organic or inorganic residues on the subjecting it to the sterilization cycle.
instruments (See the Chapter, “Preparing the
Material”).
Separate instruments made of different
Contact between instruments made of metals.
different metals. (See the Chapter, “Preparing the
Material”).
Clean the device and its parts, as
Lime residue on the wall of the
required.
sterilization chamber and/or accessories.
(See Appendix “Maintenance”).

Check the adequacy of the sterilization


temperature of the selected program in
Blackening of the instruments or relation to the material to be treated.
Wrong sterilization program selection.
damage to the material.
(See the Summary Table in Appendix
“Programs”).

71
APPENDIX – alarms

NOTE
If the problem persists, contact Technical Service (see Appendix)
communicating the sterilizer model and serial number.
This data is indicated on the registration plate on the rear of
the device and on the declaration of conformity

Introduction Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is
generated, identified by a specific code (consisting of a letter followed by a 3-digit number).
Alarm codes are divided into three categories:

• E = ERROR/WARNING
Incorrect handling and/or use or a cause outside the device.
The problem can normally be solved by the user.
Code format: Exxx (xxx = identification number 000 - 999)

• A = ALARM
First level fault
The problem can normally be solved on site by a specialised technician.
Code format: Axxx (xxx = identification number 000 - 999)

• H = HAZARD
Second level fault
The problem can normally be solved by the Technical Service Centre.
Code format: Hxxx (xxx = identification number 000 - 999)

• S = SYSTEM ERROR
Electronic system error (HW-FW).
Code format: Sxxx (xxx = identification number 000 - 999)

NOTE
IN THE CASE OF AN ALARM, PLEASE ONLY REMOVE VOLTAGE FROM
THE DEVICE AFTER EXECUTING A RESET (SEE THE PARAGRAPH,
“RESETTING THE SYSTEM”).

alarm When the alarm intervenes, the cycle (or normal operation) is interrupted, the relative alarm code
and message are shown on the display and an acoustic warning is sounded .
intervention

Alarm during a cycle The alarm procedure has been devised so that the user cannot confuse an abnormal cycle with a
correctly completed cycle and hence involuntarily use non-sterile material ; it is structured to
guide the user up to sterilizer RESET and subsequent use.

72
SYSTEM RESET

The system can be reset in two alternative ways depending on the type of alarm that has occurred (see the list of alarm codes
further on in this appendix):

1. Pressing the OK button

2. Following the on-screen instructions and holding down the RESET button for about 3 seconds.

ERROR
Error DESCRIPTION

ERROR CODE 00:42 MPX INTERRUPTED


E150 OK

CYCLE FAILED H401

00:42

RESET

Tap and hold the RESET button for 3 seconds, the sterilizer door opens and the device goes back to the initial menu.

TEST

After the RESET and any technical operation necessary to eliminate the fault, the device will be ready to execute a new program.

WARNING

Never turn off the device before having done the Reset.

73
Alarm Codes
The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows:

CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

ERRORS (category E)

E000 Blackout BLACKOUT 2


E001 Excessive mains voltage OVERVOLTAGE 1
E002 Water conductivity threshold 1 exceeded H2O QUALITY INSUFFICIENT 1
E003 Water conductivity threshold 2 exceeded H2O QUALITY INSUFFICIENT 1
E010 Door open DOOR OPEN 1
1
Door lock system activation timeout excee-
E020 DOOR LOCK TIMEOUT (then reattempt or turn
ded (closing)
off)
1
Door lock system activation timeout excee-
E021 DOOR LOCK TIMEOUT (then reattempt or turn
ded (opening)
off)

E022 Door lock microswitch failure (OFF-OFF) DOOR LOCK PROBLEM 2


The water in the feed tank is at minimum
E030
level (MIN)
MIN WATER LEVEL 1
The water in the drain tank is at maximum
E031
level (MAX)
MAX DRAIN LEVEL 1
E040 Tank filling failed (automatic filling) TOP-UP PROBLEM 1
Too frequent tank filling
E041
(automatic filling)
TOP-UP PROBLEM 1
The maximum water level in the filling tank
E042
has been reached
MAX FILLING LEVEL 1

E260 Chamber depressurization too slow PPD SLOW 1

E261 Chamber levelling too slow LEVELLING SLOW 1


Vacuum test failed
E900
(during TEST PHASE)
TEST FAILED 2
Vacuum test failed
E901
(during STANDBY PHASE)
TEST FAILED 2
Vacuum test failed
E902
( vacuum pulse timeout exceeded)
TEST FAILED 2
E999 Manually interrupting the cycle MANUAL INTERRUPTION 2

1 = OK (warning)
2 = OK + door unlocking + RESET

74
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

ALARMS (category A)

A032 Problem with the level sensor H2O LEVEL PROBLEM 1


The tank has not been filled (only with automa-
A040
tic filling system)
TOP-UP PROBLEM 1
The maximum water level in the filling tank has
A042
abnormally been reached
TOP-UP PROBLEM 1
Temperature sensor PT1 failed
A101
(sterilization chamber)
PTx INTERRUPTED 1
Temperature sensor PT2 failed
A102
(steam generator)
PTx INTERRUPTED 1
Temperature sensor PT3 failed
A103
(heating element)
PTx INTERRUPTED 1
Temperature sensor PT5 failed
A105
(conductivity measurement compensation)
PTx INTERRUPTED 1
Temperature sensor PT1 short-circuited
A111
(sterilization chamber)
PTx SHORT-CIRCUITED 1
Temperature sensor PT2 short-circuited
A112
(steam generator)
PTx SHORT-CIRCUITED 1
Temperature sensor PT3 short-circuited
A113
(heating element)
PTx SHORT-CIRCUITED 1
Temperature sensor PT5 short-circuited
A115
(conductivity measurement compensation)
PTx SHORT-CIRCUITED 1

A116 ADC error ADC error 1


Reference heating element acquisition chain Reference heating element
A120
fault fault 1
Reference heating element acquisition chain Reference heating element
A121
fault fault 1
Reference heating element acquisition chain Reference heating element
A122
fault fault 1
Reference heating element acquisition chain Reference heating element
A123
fault fault 1
Reference heating element acquisition chain Reference heating element
A124
fault fault 1
Reference heating element acquisition chain Reference heating element
A125
fault fault 1
Pre-heating not executed within timeout (ste-
A201
am generator)
GENERATOR WARM-UP PROBLEM 2
Pre-heating not executed within timeout (tube HEATING ELEMENT WARM-UP
A202
bundle heating element) PROBLEM 2

1 = OK (warning)
2 = OK + door unlocking + RESET

75
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

ALARMS (category A)
1st vacuum pulse not reached within the ti-
A250
meout
PV1 TIMEOUT 2
1st rise back up to atmospheric pressure not
A251
reached within the timeout
ATM1 TIMEOUT 2
1st pressure pulse not reached within the ti-
A252
meout
PP1 TIMEOUT 2
2nd vacuum pulse not reached within the ti-
A253
meout
PV2 TIMEOUT 2
2nd rise back up to atmospheric pressure not
A254
reached within the timeout
ATM2 TIMEOUT 2
2nd pressure pulse not reached within the
A255
timeout
PP2 TIMEOUT 2
3rd vacuum pulse not reached within the ti-
A256
meout
PV3 TIMEOUT 2
3rd rise back up to atmospheric pressure not
A257
reached within the timeout
ATM3 TIMEOUT 2
3rd pressure pulse not reached within the ti-
A258
meout
PPP TIMEOUT 2
Chamber depressurization not completed
A260
within the timeout
PPD TIMEOUT 2
Chamber levelling not completed within the
A261
timeout
LEVELLING TIMEOUT 2
1st drop to atmospheric pressure not comple-
A353
ted within the timeout
DRAIN TIMEOUT 2
2nd drop to atmospheric pressure not comple-
A356
ted within the timeout
DRAIN TIMEOUT 2
Vacuum pulsation during drying not executed
A360 TIME OUT PPD
within timeout

1 = OK (warning)
2 = OK + door unlocking + RESET

76
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

HAZARDS (category H)

H150 The MPX pressure sensor is broken MPX interrupted 2


H160 MPX sensor short-circuited/not connected MPX SHORT-CIRCUITED 2
Pconv/T ratio not balanced (Pconv>T)
H400
( PROCESS phase)
Incorrect P/T ratio 2
T/Pconv ratio not balanced (T>Pconv)
H401
( PROCESS phase)
Incorrect P/T ratio 2
Temperature above the MAXIMUM limit
H402
( PROCESS phase)
T above MAX limit 2
Temperature below the MINIMUM limit
H403
( PROCESS phase)
T below MIN limit 2
Temperature fluctuating over limit
H404
( PROCESS phase)
T FLUCTUATING OVER LIMIT 2
Pressure above MAX limit
H405
( PROCESS phase)
P above MAX limit 2
Pressure below Min limit
H406
( PROCESS phase)
P BELOW MIN LIMIT 2
Retention time incorrect
H410
(PROCESS phase)
TIMER PROBLEM 2
Excessive pressure
H990
(sterilization chamber, MPX)
EXCESSIVE PRESSURE 2
Overheating
H991
(sterilization chamber, PT1)
PT1 OVERHEATING 2
Overheating
H992
(steam generator, PT2)
PT2 OVERHEATING 2
Overheating
H993
(tube bundle heating element, PT3)
PT3 OVERHEATING 2

CODE ALARM DESCRIPTION LCD INDICATION RESET MODE

SYSTEM ERRORS (category S)

S001 Flash Memory Failure Flash memory not accessible 2


S002 Flash memory full Flash Full 2
S003 SD memory card not accessible SD Card not accessible 3
S004 SD memory card full SD Card full 2
S005 USB Key Failure USB Stick not accessible 2
S006 USB stick not accessible USB Stick not accessible 2
S007 USB stick full USB stick full 2
SD memory card not accessible (you can not
S008
transfer data)
SD Card not accessible 2
S009 Printer not connected NO PRINTER 2
Printer: there is no paper or there might be a con-
S010
figuration error
PRINTER: NO PAPER 2
S011 Printer cover open PRINTER: DOOR OPEN 2
S012 Probable printer configuration error PRINTER NOT READY 2

1 = OK (warning)
2 = OK + door unlocking + RESET

77
Analysis and resolution of problems
Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct operation:

ERRORS (category E)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION


Wait for the power to be restored and do a RESET following
Sudden power failure (blackout).
the instructions.

The main switch has accidentally been turned off Reconnect the plug and/or turn the device on again and Reset
and/or the power plug pulled from the socket. according to the instructions.
E 000

Replace with new fuses of the same nominal value. (See sum-
The mains fuses have burned mary table in the Appendix "Technical features"). Turn the
device on again and Reset according to the instructions.

Reset according to the instructions. If the problem occurs


E001 Abnormal voltage peak on the mains
again, have the mains electric system checked by a technician.

Reset according to the instructions. Empty the feed tank and


refill it with distilled water of adequate quality (<15µs/cm). If an
E002 The feed tank contains water of inadequate quality. automatic filling system is present, empty the external contai-
ner and fill it with water of adequate quality. If a demineralizer
(Pure100/500) is present, replace the filter elements.

Reset according to the instructions. IMMEDIATELY empty


the feed tank and refill it with distilled water of adequate quality
(<15µs/cm). If an automatic filling system is present, IMME-
DIATELY empty the external container and fill it with water of
adequate quality. If a demineralizer (Pure100/500) is present,
E003 The feed tank contains water of very poor quality. IMMEDIATELY replace the filter elements.
NOTE: In these conditions, the sterilizer allows starting a MAXI-
MUM OF 5 CONSECUTIVE CYCLES, after which it locks until
the tank is filled with distilled water of adequate quality (<15µs/
cm). This precaution is necessary to prevent possible damage
to the device.

Door open (or not properly closed) at program start Reset according to the instructions.
(START). Properly close the doorand restart the program.
E010
Contact Technical Service
Door position microswitch failure.
(see Appendix).

Reset according to the instructions.


Door lock mechanism limit microswitch failure.
Try restarting the program a second time.
E020
If the problem persists, contact Technical Service (see the
Door lock system gearmotor failure. Appendix).

Reset according to the instructions.


Door lock mechanism limit microswitch failure.
E021 Contact Technical Service
(see Appendix).
Door lock system gearmotor failure.
Reset according to the instructions.
E022 Door interlock microswitch failure (OFF-OFF)
Contact Technical Service (see Appendix).

Reset according to the instructions.


Water level in the feed tank below minimum. Top up with water up to the MAX level (or at least up to over the
E030 MIN level).

Contact Technical Service


MIN water level sensor failure.
(see Appendix).

78
CODE POSSIBLE CAUSE PROPOSED SOLUTION

Reset according to the instructions and empty the tank.


Water level in the drain tank over the MAX level
Completely drain the drain tank.
E031

Contact Technical Service


MAX water level sensor failure.
(see Appendix).

Reset according to the instructions.


Check that the filling tube is properly connected (see the
Automatic filling system not properly installed.
section Installation).
E041 Remove any obstruction along the tube path.

Automatic filling system failure.


Contact Technical Service
Problem in the hydraulic circuit. (see Appendix).

Warning that the maximum water level in the tank


E042 Interrupt the filling operation to prevent water spillage.
has been reached
Clean the drain filter (see the Appendix "MAINTENAN-
Drain filter obstructed.
CE").
E260
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Clean the drain filter (see the Appendix "MAINTENAN-


Bacteriological filter obstructed.
CE").
E261
Problem in the hydraulic circuit Contact Technical Service (see Appendix).

Reset according to the instructions.


Thoroughly clean the gasket with a clean cotton cloth moiste-
Air seepage through the gasket ned with water.
E900 Restart the program.
Contact Technical Service
Problem in the hydraulic circuit.
(see Appendix).

Reset according to the instructions.


Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the
program.

Reset according to the instructions.


E901 Thoroughly clean the gasket with a clean cotton cloth moi-
Air seepage through the gasket
stened with water.
Restart the program.

Contact Technical Service


Problem in the hydraulic circuit.
(see Appendix).

Reset according to the instructions.


Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the
program.
Reset according to the instructions.
Thoroughly clean the gasket with a clean cotton cloth moi-
E902 Air seepage through the gasket
stened with water.
Restart the program.

Vacuum pump failure.


Contact Technical Service
Problem in the hydraulic circuit. (see Appendix).

Manual interruption of the sterilization or test


E 999 Reset according to the instructions.
cycle.

79
ALARMS (category A)

A 022 Door lock mechanism limit microswitch failure. Contact Technical Service (see Appendix).

Reset according to the instructions.


No water in the external tank (automatic filling) Fill the tank with a sufficient amount of water
(remember to periodically check the level).

Reset according to the instructions.


A040
Check proper connection of the filling tube.
Automatic filling system incorrectly installed.
Remove any possible obstruction along the
tube path.
Contact Technical Service
Automatic filling system failure.
(see Appendix).
Contact Technical Service
A042 Problem to the Automatic filling system
(see Appendix).

A 101 Chamber temperature sensor failure (PT1).

A 102 Steam generator temperature sensor failure (PT2).

A 103 Heating element temperature sensor failure (PT3).

Temperature sensor PT5 failed


A 105
(conductivity measurement compensation)

Incorrect temperature sensor connection (sterilization chamber).


A 111 Contact Technical Service
Temperature sensor short-circuit (sterilization chamber). (see Appendix).

Incorrect temperature sensor connection (steam generator).


A 112
Temperature sensor short-circuit
(steam generator).

Incorrect temperature sensor connection (heating element).


A 113
Temperature sensor short-circuit (heating element).
Temperature sensor PT5 short-circuited
A115
(conductivity measurement compensation)

A116 ADC error

A120 Reference heating element acquisition chain fault


Contact Technical Service
(see Appendix).
A121 Reference heating element acquisition chain fault

A122 Reference heating element acquisition chain fault

80
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Reference heating element acquisition
A123
chain fault

Reference heating element acquisition


A125
chain fault

Steam generator safety thermostat inter-


vened.
A 201
Steam generator or heating element mal-
function.

Heating element safety thermostat inter- Contact Technical Service (see Appendix).
vened.
A 202
Steam generator or heating element mal-
function.

A 203 Steam generator malfunction

A 204 Heating element malfunction

Reset according to the instructions.


Thoroughly dry the inside of the sterilization chamber and restart the
Water or condensate in the sterilization
cycle.
chamber.
Do not insert material impregnated with water or liquids in general into
the chamber.
Clean the drain filter
Drain filter obstructed.
(see the Appendix "MAINTENANCE").

A 250 Reset according to the instructions.


Thoroughly clean the gasket with a clean cotton cloth moistened with
Air seepage through the gasket.
water.
Restart the cycle.

Vacuum pump failure.


Contact Technical Service
(see Appendix).
Problem in the hydraulic circuit.

Water injection pump malfunction.

Problem in the hydraulic circuit.

Contact Technical Service


A 251 Steam generator safety thermostat inter- (see Appendix).
vened.

Steam generator malfunction

81
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Reset according to the instructions.


Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water.
Restart the cycle.

Reset according to the instructions.


Excessive load. Check that the load does not exceed the maximum values permitted.
A 252 (see Summary Table in the Appendix Technical Features).

Problem in the hydraulic circuit.

Steam generator safety thermostat Contact Technical Service (see Appendix).


intervened.

Steam generator malfunction

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE”)
A 353
Problem in the hydraulic circuit Contact Technical Service (see Appendix).

Reset according to the instructions.


Thoroughly dry the inside of the sterilization chamber and restart the pro-
Water or condensate in the sterilization
gram.
chamber.
Do not insert material impregnated with water or liquids in general into the
chamber.

Reset according to the instructions.


A 253
Air seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water.
Restart the program.

Vacuum pump failure.


Contact Technical Service
(see Appendix).
Problem in the hydraulic circuit.

Water injection pump malfunction.

Problem in the hydraulic circuit.

Contact Technical Service


A 254 Steam generator safety thermostat
(see Appendix).
intervened.

Steam generator malfunction

82
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Reset according to the instructions.


Thoroughly clean the gasket with a clean cotton cloth moistened with wa-
Steam seepage through the gasket.
ter.
Restart the program.

Reset according to the instructions.


Excessive load. Check that the load does not exceed the maximum values permitted.
(see Summary Table in theAppendix Technical Features).
A 255

Problem in the hydraulic circuit.

Steam generator safety thermostat Contact Technical Service


intervened. (see Appendix).

Steam generator malfunction

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 356
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Reset according to the instructions.


Thoroughly dry the inside of the sterilization chamber and restart the pro-
Water or condensate in the steriliza-
gram.
tion chamber.
Do not insert material soaked with water or liquids in general into the
chamber.

Reset according to the instructions.


A 256
Thoroughly clean the gasket with a clean cotton cloth moistened with wa-
Air seepage through the gasket.
ter.
Restart the program.

Vacuum pump failure.


Contact Technical Service
Problem in the hydraulic circuit. (see Appendix).

Water injection pump malfunction.

Problem in the hydraulic circuit.


Contact Technical Service
A 257 Steam generator safety thermostat
(see Appendix).
intervened.

Steam generator malfunction

Reset according to the instructions.


Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water
and restart the program.
A 258 Reset according to the instructions.
Excessive load. Check that the load does not exceed the maximum values permitted.
(see SUMMARY TABLE in the Appendix TECHNICAL FEATURES).

Problem in the hydraulic circuit. Contact Technical Service ( see Appendix).

83
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Steam generator safety thermostat


intervened.
Contact Technical Service
A 258
(see Appendix).
Steam generator malfunction

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 260
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Drain filter obstructed. Clean the drain filter (see Appendix: “Maintenance”).
A 360
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Bacteriological filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 261
Problem in the hydraulic circuit Contact Technical Service (see Appendix).

84
HAZARDS (category H)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION


H 150 Pressure sensor (MPX) failure.
Pressure sensor (MPX) not properly connected to
H 160 the connector.
Pressure sensor (MPX) short-circuit.
H 400 Problem in the hydraulic circuit.
H 401 Problem in the hydraulic circuit.
Steam generator malfunction.
H 402
Problem in the hydraulic circuit.
Steam generator malfunction.
H 403
Problem in the hydraulic circuit.
Problem in the hydraulic circuit. Contact Technical Service
H 404 (see Appendix).
Steam generator malfunction.
Problem in the hydraulic circuit.
H 405
Steam generator malfunction.
Problem in the hydraulic circuit.
H 406
Steam generator malfunction.
H 410 Timer problem
H 990 General operating problem.

H 991 General operating problem.

H 992 General operating problem.

H 993 General operating problem.

SYSTEM ERRORS (category S)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

S001 Flash Memory Failure

S002 Flash memory full

S003 SD memory card not accessible

S004 SD memory card full

S005 USB Key Failure

S006 USB stick not accessible


Contact Technical Service
S007 USB stick full (see Appendix).
SD memory card not accessible (you can not transfer
S008
data)
S009 Printer not connected
Printer: there is no paper or there might be a configu-
S010
ration error
S011 Printer cover open

S012 Probable printer configuration error

85
APPENDIX – USER DELETION PIN

IF THE ADMIN USER ENTERS THE PIN INCORRECTLY THREE TIMES, THE
NEXT TIME THE PIN IS REQUESTED, THE FOLLOWING UNLOCKING CODE
NEEDS TO BE ENTERED:

9999

86
APPENDIX – ACCESSORIES

PURE 100 PURE 500

AUTOMATIC FILLING FRONT FILLING

For management of the automatic filling accessories, refer to the previous section WATER FILLING
and to the Accessory Manual.

H2O AUXILIARY SOLENOID VALVE

PRINTER PRINTER

For printer connection, refer to the section "PRINTER".

87
PRINTER Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure).
CONNECTION

Load the desired type of paper and turn on the printer.


Set the type of paper loaded (see the paragraph PRINT MANAGEMENT)

NOTE
REFER TO THE PRINTER MANUAL FOR PRINTER STARTING AND PAPER LOA-
DING.

88
APPENDIX – TECHNICAL SUPPORT

FOR ANY REQUEST FOR


TECHNICAL SERVICE FOR THE
PRODUCT,
WHETHER IN OR OUT OF
WARRANTY,
DIRECTLY CONTACT THE

TECHNICAL SUPPORT
DEPARTMENT

OF THE DEALER OR RESELLER


THAT SUPPLIED THE PRODUCT.

We will gladly provide any information you may need on the product as well as give you suggestions and advice on the steam
sterilization procedures.

In this regard, please refer to the following address:

www.castellini.com

89

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