ELARA11 Operation

OPERATION
&
MAINTENANCE
MANUAL
Pre-vacuum Tabletop Autoclave
Model ELARA
Cat. No. MAN205-0342002EN Rev A

Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540
TABLE OF CONTENT
1. GENERAL................................................................................................................ 4
1.1.
1.2.
1.3.
INCOMING INSPECTION ........................................................................... 4

WARRANTY .............................................................................................. 4
WARRANTY STATEMENT ......................................................................... 4
2. SAFETY INSTRUCTIONS .................................................................................... 6

3. GENERAL INFORMATION ................................................................................. 7
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.9.
3.10.
3.11.
INTENDED USE ......................................................................................... 7

INTRODUCTION ........................................................................................ 7
OPERATING CONDITIONS ........................................................................ 8
SPECIFICATIONS ...................................................................................... 9
UTILITIES ............................................................................................... 10
ENVIRONMENT EMISSION INFORMATION ............................................. 10
ELECTRICAL DATA ................................................................................ 10
CONSTRUCTION ..................................................................................... 11
SYMBOL DESCRIPTION .......................................................................... 11
WATER QUALITY ................................................................................... 12
DIRECTIVES AND STANDARDS ............................................................... 13
4. KEYBOARD .......................................................................................................... 16
4.1.
4.2.
DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD ..... 17

DISPLAYED ERROR AND OPERATIONAL MESSAGES ............................. 19
5. STERILIZATION PROGRAMS ......................................................................... 22

5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
5.7.
5.8.
PROGRAM 1: FLASH 134........................................................................ 23

PROGRAM 2: P 134 ................................................................................ 24
PROGRAM 3: WDRY 134 ....................................................................... 25
PROGRAM 4: NODRY 121 ...................................................................... 26
PROGRAM 5: WDRY 121 ........................................................................ 27
PROGRAM 6: DELICATE 121.................................................................. 28
TEST 1: B&D TEST ................................................................................ 29
TEST 2: VACTEST .................................................................................. 30
6. MONITORING AND CHANGING PARAMETERS AND OTHER DATA .. 31

6.1.
6.2.
6.3.
6.4.
MENU ..................................................................................................... 31
PARAMETERS ......................................................................................... 32
SETTING THE CLOCK ............................................................................. 33
HISTORY................................................................................................. 34
7. PRINTER................................................................................................................ 35
7.1.
7.2.
PRINTER OUTPUT .................................................................................. 35

PRINTER HANDLING .............................................................................. 37
8. PREPARATION BEFORE STERILIZATION.................................................. 39

8.1.
8.2.
8.3.
PACKS..................................................................................................... 40
TUBING ................................................................................................... 41
WRAPPED INSTRUMENTS....................................................................... 41
9. OPERATING INSTRUCTIONS .......................................................................... 42

9.1.
9.2.
9.3
9.4
FILLING THE MINERAL-FREE WATER RESERVOIR. ............................ 42

TURNING ON THE AUTOCLAVE .............................................................. 43
OPENING THE DOOR............................................................................... 43
LOADING ................................................................................................ 43
Page 1 of 56
9.5.
9.6.
9.7.
9.8.
9.9.
OPERATIONS .......................................................................................... 43
UNLOADING ........................................................................................... 44
STOPPING THE PROCESS ........................................................................ 44
CANCELING THE ERROR MESSAGE ..................................................... 44
SLEEP MODE .......................................................................................... 44
10. MAINTENANCE INSTRUCTIONS ................................................................... 45

10.1.
10.2.
10.3.
10.4.
10.5.
10.6.
10.7.
PREVENTIVE AND SCHEDULED MAINTENANCE .................................... 45

DRAINING THE RESERVOIRS ................................................................. 47
REPLACING THE AIR FILTER ................................................................ 48
REPLACING THE DOOR GASKET ........................................................... 49
CHECKING THE SAFETY VALVE ............................................................ 50
CLEANING WATER STRAINER ................................................................ 52
EMERGENCY OPENING OF THE DOOR .................................................... 53
11. TROUBLESHOOTING ........................................................................................ 54

12. SPARE PARTS LIST ............................................................................................ 56
13. ACCESSORIES ..................................................................................................... 56
Page 2 of 56
TABLE OF ILLUSTRATIONS
FRONT VIEW ........................................................................................................... 14
REAR VIEW ............................................................................................................. 15
TRAY HANDLE ........................................................................................................ 55
POUCH RACK .......................................................................................................... 55
TRAY
................................................................................................................ 55
TRAY HOLDER ........................................................................................................ 55
Page 3 of 56
1.
GENERAL
Read the Operating Instructions carefully, before beginning any
operation on the autoclave!
1.1.
Incoming Inspection
The autoclave should be unpacked and inspected for mechanical
damage upon receipt. Observe packing method and retain packing
materials until the unit has been inspected. Mechanical inspection
involves checking for signs of physical damage such as: scratched
panel surfaces, broken knobs, etc.
If damage is apparent, contact your dealer or point of purchase, so that
they may notify the manufacturer and file a claim with the appropriate
carrier.
All Tuttnauer products are carefully inspected prior to shipment and all
reasonable precautions are taken in preparing them for shipment to
assure safe arrival at their destination.
1.2.
Warranty
We certify that this instrument is guaranteed to be free from defects in
material and workmanship for one year against faulty components and
assembly with the exception of the heaters.
The warranty does not include and does not replace routine
treatment and preventive maintenance to be performed according
to instructions in paragraph 10. (Preventive and Scheduled
Maintenance).
Our obligation is limited to replacing the instrument or parts, after our
examination, if within one year after the date of shipment they prove to
be defective. This warranty does not apply to any instrument that has
been subjected to misuse, neglect, accident or improper installation or
application, nor shall it extend to products that have been repaired or
altered outside the factory without prior authorization from us.
The Autoclave should not be used in a manner not described in this
manual!
1.3.
Warranty Statement
The warranty registration must be completed and returned to our service
departments; within fourteen (14) days of purchase or the warranty will
be void.
Our Technical Service Dept. can be reached at:
Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540, E-mail: info@tuttnauer.nl.
Note:
If there is any difficulty with this instrument, and the solution is not
covered in this manual, contact our representative or us first. Do not
attempt to service this instrument yourself. Describe the difficulty as
clearly as possible so we may be able to diagnose the problem and
provide a prompt solution.
If the autoclave is equipped with a printer, send along a copy of the last
printout for our inspection. If service or replacement parts are needed,
contact the dealer or our Technical Service Department. in your call
stipulate the model (written on the front) and the serial number of the
machine (written on the left side).
Page 4 of 56
No products will be accepted for repair without proper authorization

from us. All transportation charges must be paid both ways by the
owner. This warranty will be void if the unit is not purchased from an
authorized full service Tuttnauer dealer.
Page 5 of 56
2.
SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand the
operation instructions before first operation of the autoclave. This manual
includes instructions guidance provided by the manufacturer: how to operate
the autoclave, the door safety mechanism, and the hazards involved in
circumventing safety means and how to select an adequate sterilization
program.
Make sure that you know where the main power switch is located.
Autoclave maintenance is crucial for the safe and effective function of the
device.
The daily B&D test, at the beginning of the working day, is part of the
preventive maintenance plan, along with the annual validation of the
sterilization processes that ensures appropriate sterilization conditions.
Never use the autoclave to sterilize liquids since it is not designed to sterilize
liquids.
Below are the operating instructions safety instructions:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
All autoclave users must receive training in proper usage from an

experienced employee. Every new employee must undergo a training
period under an experienced employee.
Before use, check inside the autoclave chamber to ensure that no items
have been left from the previous cycle.
Load trays in such a way as to allow steam to move freely among all items.
When sterilizing plastic materials, make sure that the item can withstand
sterilization temperature. Plastic that melts in the chamber is liable to
cause a great deal of damage.
Individual glass bottles shall be placed on a tray.
On closing the device door, make sure it is properly locked before
activating. Verify that DOOR OPEN
symbol is replaced by the load
number.
Verify once again that you have chosen the appropriate sterilization
program.
Before withdrawing trays, wear heat resistant gloves.
Before opening the door, verify that there is no pressure in the chamber
(chamber pressure is displayed on the screen).
Open the door slowly to allow steam to escape and wait 1 minute before
you remove the load.
Once a month, ensure that the safety valve is operating.
A certified inspector must perform a periodic pressure chamber safety
test according to the local regulations.
Once annually, or more frequently, effectiveness tests must be performed,
i.e., calibration and validation.
Make sure there are no leaks, breaks, blockages, whistles or strange noises.
Perform maintenance operations as instructed. The owner of the
autoclave is responsible to perform the maintenance operations.
Notify the person in charge immediately of any deviation or risk for the
proper function of the device.
Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or
rules!
Page 6 of 56
3.
GENERAL INFORMATION
3.1.
Intended Use
This table-top autoclave is designed for sterilization of medical and
surgical goods such as unwrapped and wrapped, solid, hollow, porous
products and tubes in ophthalmic, dental and medical clinics, first aid
rooms, small laboratories etc.
3.2.
Introduction
This autoclave model is an electrically heated sterilizer using steam as a
sterilizing agent.
The autoclave is designed as Type B in accordance with EN13060.
This model is a prevacuum sterilizer having the following features;
An air removal stage (prevacuum), before starting the sterilizing
stage.
A post-sterilization drying phase, based on the combined operation
of heat and vacuum with air inlet pulses.
There are following safety devices installed in the autoclave to
optimize the safety operation:
1. Two thermostats, for over-heating of generator and the chamber.
2. Two safety pressure valves for generator and chamber.
An absolute digital display is used for monitoring and control
purposes. This device displays the pressure in kPa or in psi, according
to the operators requirement, and the absolute zero is displayed as 0.
This displayed pressure indicates the pressure in the chamber.
The advantages of the prevacuum sterilizer are as follows:
Removal of residual air from packs and porous load and most kinds
of tubes (rubber, plastic etc.) by vacuum at the first stage of the
cycle.
More efficient steam penetration into the load; assuring effective
sterilization.
Improved temperature uniformity.
Better drying of materials due to the vacuum achieved in the
chamber at the end of the sterilization cycle.
The printer prints the preset and actual parameters of the cycle
(temperature, time and pressure/vacuum).
This Manual is intended for the user and gives the user a general
understanding of the instrument and the best ways to operate and take
care of it in order to obtain effective results.
Before operating this autoclave read carefully the Operation Manual.
After reading this Manual, operating the autoclave will be easy.
However since this instrument is built with high technology sensitive
components, no attempt should be made by the user or any other
unauthorized person to repair or recalibrate it.
Only technical personnel having proper qualifications and holding
technical documentation (including a Technician Manual) and
adequate information are authorized to install and service the
apparatus.
Page 7 of 56
3.3.
Operating Conditions
This device is for indoor use only!
The sterilizer should be loaded only with autoclavable material!
Minimum room ventilation shall be10 cycles per hour
The environment shall not exceed an ambient temperature range of
5C-40C and a relative humidity of 85% respectively.
The operation altitude shall not be over 2000 meters (ambient pressure
shall not be lower than 80 kPa (11.6 psi)).
CAUTION!
Waste water should be brought into the public net in accordance
with the local rules or requirements
ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN

PUBLIC SEWAGE!
Page 8 of 56
3.4.
Specifications
Overall Dimensions
Front View
Top View
Property
Value
Max. Allowable Working Pressure

Chamber
(MAWP)
Diameter
Depth
Chamber volume
External dimensions
Distance between supporting legs

F - rear legs
F1 - front legs
Width (A)
Height (B)
Length (C)
Length with
open door (D)
K
F
F1
Maximum load per item

Maximum load per tray
Maximum solid load
Maximum textile load
W
H
L
Tray dimensions
No. of trays
IMS cassettes (optional)
Page 9 of 56
2.8 bar (40 psi)

280 mm (11)
504 mm (19.8)
28.5 lit. (7.5 gal)
530 mm (20.8)
444 mm (17.4)
645 mm (25.4)
950 cm (36.6)
452 mm (17.8)
315 mm (12.4)
400 mm (15.7)
0.5 kg (1.1 lb)
2.0 kg (4.4 lb)
8.0 kg (17.6 lb)
2.0 kg (4.4 lb)
212 mm (8.3)
21 mm (0.8)
350 mm (13.7)
5
4
Property
Value
Weight
66 kg (145.5 lb)
1.71 N/m2
(0.036 lb/ft2)
71 kg (156 lb)
63 cm (24.8)
71 cm (28.0)
80 cm (35.8)
0.36 m3 (14.5 ft3)
Weight per support area (max. load)

Shipping weight
Width
Height
Shipping dimensions
Length
Volume
Max. water
volume
Mineral-free water reservoir
Min. water
volume
Max. water
Used (waste) water reservoir
volume
3.5.
6.6 lit. (1.74 US gal)

2.6 lit. (0.68 US gal)
5.2 lit. (1.37 US gal)
Utilities
Utility
Value
Mineral free water
See table in para 3.10.

* 1 phase, 200/208/230 10% Vac,
50/60Hz
15A
Power supply
Recommended circuit breaker
* According to the local network.
Attention:
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.
3.6.
Environment Emission Information

1. The peak sound level generated by the autoclave is 65dBa with
background noise of 48 dBa.
2.
3.7.
Note:
The total heat per hour transmitted by the autoclave is <200Wh.
Electrical Data
Property
Value
Total Power
2300W
Voltage
1 ph / 230 Vac
Amperage
10A
Protection against electrical shock
Class I (IEC 60601-1)
Mains supply fluctuation
+/- 10%
In order to avoid any injury by electrical hazard, it is

recommended that a ground fault protection device be installed in
the electrical panel feeding the autoclave (local codes may make
this mandatory).
Page 10 of 56
3.8.
Construction
The main parts of the autoclave are made of materials as indicated
below:
Chamber is built of stainless steel 316 L.
Door is made of stainless steel 316.
Trays are made of stainless steel 304.
Water reservoir is made of polyethylene.
Door handle is made of hard plastic material, which is safe to
touch and thermo-insulated.
3.9.
Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
Page 11 of 56
3.10.
Water Quality
Physical characteristics and contaminants levels
The distilled or mineral free water supplied to the autoclave should
have the physical characteristics and maximum acceptable level of
contaminants indicated in the table below:
Physical Characteristics and Maximum acceptable contaminants
levels in steam for sterlizers
(According to EN 13060:2004).
Condensate allowable
Element
content
Silicium oxide. SIO2
0.1 mg/kg
Iron
Cadmium
Lead
Rest of metals except iron,
cadmium, lead
Chloride (Cl)
Phosphate (P2O5)
Conductivity (at 20C)
pH value (degree of acidity)
Appearance
Hardness ( Ions of alkaline earth)
0.1 mg/kg
0.005 mg/kg
0.05 mg/kg
0.1 mg/kg
0.1 mg/kg
0.1 mg/kg
3 s/cm
5 to 7
Colourless clean without
sediment
0.02 mmol/l
Compliance with the above data should be tested in accordance

with acknowledged analytical methods, by an authorized
laboratory.
Attention:
We recommend testing the water quality once a month. The use of
water for autoclaves that does not comply with the table above may
have severe impact on the working life of the sterilizer and can
invalidate the manufacturers guarantee.
Page 12 of 56
3.11.
Directives and Standards

Every autoclave meets the provisions of the following Directives and is
in compliance with the following Standards:
3.11.1.
Technical Standards
1.
EN 13060:2004 Small Steam Sterilizers.
2.
ASME Code, section VIII division 1 for pressure

vessels.
3.
EN 61326, Electrical equipment for measurement,

control and laboratory use-EMC requirements
4.
UL/IEL/EN 61010-1 electrical

laboratory use; general requirements
5.
UL/IEL/EN 61010-2-040 particular requirements for

sterilizers and washer disinfectors used to treat medical
materials.
equipment
for
The following standards were taken in consideration:

6.
3.11.2.
ISO 17665-1:2006 specifies requirements for the

development, validation and routine control of a moist
heat sterilization process for medical devices.
Quality standards
The manufacturing plant meets the following quality
standards:
1.
EN ISO 9001:2008 Quality System
2.
ISO 13485:2003 Quality systems Medical devices.
Page 13 of 56
FRONT VIEW
18
17
16
13
15
14
13
12
11
No. Description
No. Description
Water reservoir funnel
10
Operating key board
Autoclave cover
11
Printer cover
Water level side gauge
12
Printer (option)
Mineral-free water reservoir cover

Chamber and steam generator safety
valves
13
Legs
14
Waste water reservoir drain valve
Waste water reservoir cover
15
Display
16
Mineral-free water reservoir drain

valve
Door cover
Ventilation grill
17
Door switch
Main switch circuit breaker
18
Door closing device
Page 14 of 56
10
REAR VIEW
No. Description
1
Mineral-free water reservoir cover
Waste water reservoir cover
Ventilation grills
Air filter service cover
Opening for calibration
Main power electric cable socket
Page 15 of 56
4.
KEYBOARD
No.
Description
Display
Keypad
Printer
Page 16 of 56
4.1.
Description and Functions of the Front Panel Keyboard

The front panel is composed of 3 sections:
1. Display screen.
2. Keypad.
3. Printer
4.1.1.
Display screen
The display is a graphical screen used to display the current
status of the autoclave while using Operational Messages and
Error Messages.
Program icon
Sterilization temperature
Sterilization time
Dry time
Chamber temperature
Chamber pressure
Steam generator pressure
Load number
or
Error and operational
messages
Page 17 of 56
Time display:
Clock
Time countdown
4.1.2.
Keypad
The keypad consists of 3 keys as described below:
UP key
This key has the following functions:
In the main screen:
o This key enables the operator to brows
through the cycles.
In the directories available:
o When the cursor is blinking on a number,
the UP key increases its value.
o When the cursor is blinking on a word, the
UP key enables to move backward or to
browse through the directories.
DOWN key
In the main screen:
o This key enables the operator to brows
through the cycles.
the DOWN key decreases its value.
DOWN key enables to move ahead or to
browse through the directories.
START/STOP key
In the main screen:
o Starts the process when the required
program was chosen.
o Stops the current process.
o Cancels the ERROR message displayed on
the screen to open the electric door locking.
key enables to move
the START/STOP
ahead.
key enables to enter in
START/STOP
the selected directory.
4.1.3.
Printer
The printer prints the detailed history of each cycle performed
by the autoclave.
The printing is made on thermal paper with 24 characters per
line and contains the record information for subsequent
consideration.
Page 18 of 56
4.2.
Displayed Error and Operational Messages

Error
Error
Number
Name
Err:001 Pt1 out
Err:002
Err:003
Err:005
Err:007
Err:008
Err:009
Err:011
Err:012
Message Description
This message and symbol are

displayed when the Chamber
Temperature sensor Pt1 is
disconnected or out of range.
Low
This message displayed when
Temperature the temperature drops for
more than 1 second below the
sterilization temperature.
Corrective Action
Call the technician.
Check that the

autoclave is not
overloaded or check
leakage from the
door.
If the problem
persist, call the
technician.
High
This message displayed in one Check that the
Temperature of the following cases:
autoclave is not
On Heating Prevacuum and
overloaded or
Sterilization Stages:
perform a new
If Chamber Temperature is
cycle.
Grater than Limit Temperature If the problem
for more than 10 seconds.
persists, call the
Sterilization Stage:
technician.
If temperature rises 3C (6F)
above sterilization temperature
during the sterilization stage
for 10 seconds.
High Gen
This message displayed when Perform a new
Press
the Generator pressure is
cycle.
more than 40kPa (6psi) above If the problem
the required pressure.
persists, call the
technician.
High
This message displayed if
Perform a new
pressure
Chamber Pressure raises 20kPa cycle.
(3psi) above sterilization
If the problem
pressure for 5 seconds during persists, call the
the sterilization stage.
technician.
Low
This message displayed if
Perform a new
Pressure
Chamber Pressure drops
cycle.
bellow the sterilization
If the problem
pressure for 5 seconds during persists, call the
the sterilization stage.
technician.
Time Error This message displayed if the Call the technician.
real time clock is faulty.
Door is
This message displayed when Call the technician.
Open
the door is open during the
cycle.
Manual
This message displayed after
Stop
the STOP key is pressed and
cycle aborted.
Page 19 of 56
Error
Error
Number
Name
Err:013 Air Valve
Error
Err:014
Low
Vacuum
Err:015
Low Heat
Err:016
Press
Sensor
Cutout
Err:017
Pt2 out
Err:018
Press
Sensor
Cutout
Err:020
No Gen
water
Err:021
Test Fail
Message Description
Message is displayed when the
system can't reach the
atmosphere pressure in the
chamber by opening Air Valve
for 3 minutes.
The message displayed if the
system can't reach the required
vacuum conditions in the
chamber for 20 minutes.
Corrective Action
Replace air filter.
Verify that the door

is properly closed.
Perform a new
cycle.
If the problem
persists, call the
technician.
This message displayed if the Check that the
system can't reach the required autoclave is not
pressure or temperature
overloaded.
conditions in the chamber after If the problem
20 minutes during the
persists, call the
Prevacuum and Heating stages. technician.
This message and symbol are Call the technician.
displayed if the chamber
pressure sensor is
displayed when the Jacket
Temperature sensor Pt2 is
displayed if steam generator
pressure sensor is disconnected
or out of range.
This message is displayed if
Perform a new
the generator electrode has no cycle .
water for a specific time.
If the problem
persists, call the
technician.
Check the leakage
one of the test programs fails. from the door.
Dry the chamber and
try a second time.
Pour water in the
there is lack of water in the
front funnel until it
mineral-free water reservoir.
reach the full level.
Drain the reservoir.
the waste water reservoir is
full.
This message is displayed
Wait for the
while the autoclave is
autoclave to reach
preheating.
the proper operating
conditions for
staring a new cycle.
Page 20 of 56
Error
Number
Error
Name
Message Description
Corrective Action
The autoclave's door is open.
Close the door to

perform a new
cycle.
Wait for the
generator to create
steam.
The generator is not ready.
Page 21 of 56
5.
STERILIZATION PROGRAMS
The autoclave offers 6 sterilization programs and 2 test programs as follows:
Sterilization Programs:
Program 1
Flash 134
Program 2
P 134
Program 3
Wdry 134
Program 4
No Dry 121
Program 5
Wdry 121
Program 6
Delicate 121
Tests programs:
Test 1
B&D Test
Test 2
VacTest
During the process the graph of the cycle will be displayed on the screen:
1
This graph shows the different steps of the process:
V Vacuum stage:
V1 first pulse
V2 second pulse
V3 third pulse
V4 fourth pulse
H Heating stage
S Sterilization stage
E Exhaust stage
D Dry stage
T Test program
The circle (1) shows the current point of the cycle.
Page 22 of 56
5.1.
Program 1: Flash 134

Program 1 is recommended for sterilizing unwrapped instruments, at
temperatures of 134C/273F with 1 minute drying stage, which its
manufacturer declares their compliance to be sterilized in the following
conditions:
The solid load shall not exceed 8kg (17.6 lb).
Nominal Parameters
Sterilization temperature: 134C (273F).
Sterilization time: 4 minutes.
Dry time: 1 minute.
Max. cycle time: 25 minutes.
Average cycle time: 15 minutes.
Operation Sequence
Air-removal phase; two vacuum pulses as described in the diagram
below. Saturated steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization phase; temperature and pressure are maintained

constant at the pre-set level for the sterilization time.
Fast exhaust phase; steam is rapidly exhausted from the chamber

until pressure equalizes atmospheric pressure.
Note:
The sterility of instruments processed in unwrapped cycles cannot
be maintained if exposed to non-sterile environment.
Cycle start
Cycle end
Page 23 of 56
5.2.
Program 2: P 134
Program 2 is recommended for sterilizing double wrapped instruments,
porous loads and Hollow A (e.g. dental hand pieces, suction pipes)
loads at temperatures of 134C/273F with 20 minutes drying stage,
which its manufacturer declares their compliance to be sterilized in the
following conditions:
The porous load shall not exceed 2kg (4.4 lb).
Nominal parameters
Dry time: 20 minutes.
Operation Sequence
Air removal phase; three vacuum pulses as described in the diagram

Fast exhaust phase; steam is rapidly exhausted from the chamber,

followed by a continuous vacuum pulse for the drying stage,
followed by vacuum break (air inlet) until pressure equalizes
atmospheric pressure.
18
Cycle start
27
36
45
Cycle end
Page 24 of 56
54
5.3.
Program 3: WDry 134

loads at temperatures of 134C / 273F with 20 minutes drying stage,
Nominal Parameters
Operation Sequence

Fast exhaust phase; steam is rapidly exhausted from the chamber,

followed by a continuous vacuum pulse for the drying stage,
followed by vacuum break (air inlet), until pressure equalizes
Cycle start
Cycle end
Page 25 of 56
5.4.
Program 4: NoDry 121

Program 4 is recommended for sterilizing unwrapped instruments at a
temperature of 121C / 250F without drying stage, which its
conditions:
Nominal Parameters
Operation Sequence
Air removal phase; two vacuum pulses as described in the diagram


until pressure equalizes atmospheric pressure.
Note:
The sterility of instruments processed in unwrapped cycles cannot
be maintained if exposed to non-sterile environment.
Cycle end
Cycle start
Page 26 of 56
5.5.
Program 5: Wdry 121

loads at temperatures of 121C/250F with 20 minutes drying stage,
Nominal Parameters
Operation Sequence



and drying stage is performed with a continuous vacuum pulse,
followed by vacuum break (air inlet), until pressure equalizes
Cycle start
Cycle end
Page 27 of 56
5.6.
Program 6: Delicate 121

Program 6 is recommended for sterilizing delicate instruments at
temperatures of 121C/250F with slow exhaust, which its
conditions:
Nominal Parameters
Operation Sequence
Cycle start
Air removal phase; two vacuum pulses as described in the diagram


Slow exhaust phase; steam is slowly exhausted from the chamber

by pulses of the exhaust valve, until the pressure equals the
Cycle end
Page 28 of 56
5.7.
Test 1: B&D Test

Test 1 is the Bowie & Dick test program, with fixed sterilization
parameters 134C and 3.5mins, which cannot be modified by the
operator or the technician.
Nominal parameters
Sterilization temperature: 134C
Sterilization time: 3.5 minutes.
Dry time: 1 minute.
Operations Sequence


constant at the pre-set level 134C for sterilization time 3.5 minutes.
Fast exhaust phase; steam is rapidly exhausted from chamber

followed by a continuous vacuum pulse (1 minutes) and then by
vacuum break (air inlet), until pressure equalizes atmospheric
pressure.
Cycle start
Cycle end
Page 29 of 56
5.8.
Test 2: VacTest
Note:
Before performing this test, verify that the autoclave is cold and
that the autoclave is dry (not humid and no water drops).
Vacuum is produced in the chamber down to P1=17 kPa. At this stage
all the valves are close. The autoclave remains in this stage for 5
minutes. This period enables the condition in the chamber to reach
equilibrium. After the 5 minutes have elapsed the printer records the
pressure that is referred to as P2. At this point the test begins and lasts
10 minutes. At the end of the test, the printer records the results. The
pressure at the end of the test is referred to as P3. The rate of change of
P3-P2 shall not exceed 0.13 kPa/min. If P3-P2 exceed 1.3 kPa the printer
will print TEST FAIL. If P3-P2 is within the required value, the cycle
will end successfully and the printer will print "TEST ENDED".
Nominal parameters
Cycle time: 20 minutes.
Operations Sequence
Vacuum is produced into the chamber down to 17 kPa.
The vacuum pump stops.
Note:
During the test period the autoclave is not heated.
Cycle start
Cycle end
Page 30 of 56
6.
MONITORING AND CHANGING PARAMETERS AND

OTHER DATA
In order to set the autoclave's clock, check the main sterilization parameters
(sterilization time, and dry time) and to print the sterilization of one of the 40
previous cycles, the operator can enter three sub-directories and obtain the
required data.
6.1.
Menu
1. Enter the MENU screen by pressing simultaneously, 2-3 seconds,
the UP and DOWN keys.
To exit this screen, press START/STOP key to move the curser to
EXIT and press UP.
2. 0000 is displayed on the screen with the cursor blinking under the
right digit.
3. To increase the right digit, press the UP key.

4. After changing the code to 0001 move the cursor to SET by
pressing the START/STOP key four times.
5. When SET is blinking, press the UP key to enter the MENU of the
autoclave.
The following screen is displayed:
6. To brows through the sub-directories, use the UP and DOWN

keys.
7. When the required directory is blinking, press the START/STOP
key.
The required screen (see the following paragraphs) will be displayed.
8. To exit the MENU screen, press UP key to move the curser to
EXIT and press START/STOP.
Page 31 of 56
6.2.
Parameters
This directory enables the operator to watch and change the cycles
parameters. Therefore it is necessary to choose the required cycle
before entering the "MENU" directory (see "operating instructions").
For seeing or changing the parameters proceed as follows:
This CYCLE PARAMETERS screen is displayed when entering the
"PARAMETERS" directory:
The following parameters of the current cycle are displayed:

1.
Ster Time: sterilization exposure time in minutes.
2.
Dry Time: drying time in minutes.
To choose the required value, use the UP and DOWN keys. When the
required parameter is blinking press START/STOP.
The default time value is the minimum allowable value. It is possible to
increase the time value up to a maximum of 99 minutes.
1.
2.
3.
4.
5.
To move the curser from one digit to another press the

START/STOP key.
Use the UP and DOWN keys to increase or decrease the current
digit.
After changing the parameter to the required value, confirm the
new value. Do this by pressing START/STOP a few times until
SET is blinking and then press UP or DOWN.
If, before confirmation you decided not to change the parameter,
press START/STOP a few times until EXIT is blinking. Press
UP or DOWN. The display will return to the previous menu.
If, by mistake, the curser skipped the SET and reached EXIT,
continue to press START/STOP until the curser returns to SET.
Page 32 of 56
6.3.
Setting the Clock

This directory enables the operator to set the time and date.
This SET CLOCK screen is displayed when entering the directory:
When entering the SET CLOCK display, the time and date are
displayed. The curser is blinking on the "hour" digit.
The time is displayed in the upper row in the form hh:mm:ss. The
hour range is 24 hour (i.e. from 0 to 24)
The date is displayed in the lower row in the form DD:MM:YY.
1. To increase or decrease the time or the date use the UP and
DOWN keys.
2. To move the curser from one digit to another press the
START/STOP key.
3. After changing the time and the date move the curser to SAVE.
4. Confirm the new time and date by pressing UP key. While the new
time and date are being saved the following screen is displayed:
5. After saving is completed, SET CLOCK screen is displayed move

the cursor to EXIT and press UP to return to MENU screen.
Page 33 of 56
6.4.
History
This directory enables you to print the 40 previous cycles.
This HISTORY screen is displayed:
When entering the HISTORY display, the following screen is
displayed.
1. Choose the required cycle according to its number (Log Load Nu)
with the UP and DOWN key
2. Select it by pressing the START/STOP key.
3. The words "Log Load Nu" are replaced by "printing" and the
required cycle data is printed.
4. In order to leave this screen go to the option EXIT with the UP and
DOWN key and select it by pressing the START/STOP key.
Page 34 of 56
7.
PRINTER
7.1.
Printer Output
The printing is made on thermal paper with 24 characters per line and
contains the following information:
Software version
Real time
Selected program
Sterilization pressure
Sterilization temperature
Sterilization time
Dry time
When the sterilization cycle begins the printer starts printing the above
data.
After the preliminary printing, the autoclave starts performing the
sequence of operations of the cycle. The measured values of
temperature and pressure are printed at fixed time intervals, according
to the phase of the process, as shown in the table on the next page.
The data is printed from the bottom up, beginning with the date and
ending with CYCLE ENDED for a sterilization cycle or "TEST
ENDED". For an aborted cycle, CYCLE FAIL and the Error number
are printed (refer to "Displayed Error and Operational Messages").
For an example of a typical printout, see next page.
Page 35 of 56
PRINTER OUTPUT
DESCRIPTION
Operator:
To be filled in manually by operator
Time:
17:09:08
Date:
13/02/2006
CYCLE ENDED!
D 00:48:46
077.4
036.2
*
*
*
D 00:30:46
104.8
109.2
----------------------E 00:30:07
122.0
211.6
----------------------S 00:30:07
134.1
311.3
*
*
*
S 00:10:06
121.1
210.0
---------------------H 00:08:57
077.4
058.3
---------------------V 00:08:57
077.4
058.3
*
*
*
V 00:00:00
078.1
095.0
Time
C
kPa
Time sterilization cycle ended

Date sterilization cycle ended.
Dry Time:
020.0min
Ster Time:
020.0min
Ster Temp:
121.0C
Cycle: WDry
Load number: 00933
Param. Ver: 0030
Ver: Nova 4 1.20
Ser.Num: 02304101
Time: 16:18:22
Date: 13/02/2006
POWER ON
Time: 16:16:16
Date: 13/02/2006
POWER OFF
-------------------Legend
Drying time for selected program.

Sterilization time for selected program.
Sterilization temperature in chamber for selected program
Cycle name (with dry).
Cycle counter
Version of parameters setting
Software version.
Autoclave's serial number.
Time sterilization cycle started.
Date sterilization cycle started.
The device is turned on
Start time
Start date
The device is turned off
V
H
S
Vacuum stage
Heating stage
Sterilization stage
The time, temperature and pressure during drying.

Prints drying data every 3 minutes.
The time, temperature and pressure during drying.
The time, temperature and pressure during exhaust.
The time, temperature and pressure during sterilization.
Prints sterilization data every 1 minute.
The time, temperature and pressure during sterilization.
The time, temperature and pressure during heating.
The time, temperature and pressure during air removal.
Prints sterilization data every 3 minute or on upper and
lower peak (the shorter time)
The time, temperature and pressure during air removal.
Time, temperature and pressure columns
E
D
T
Page 36 of 56
Exhaust stage
Drying stage
Test
7.2.
Printer Handling
7.2.1.
Maintenance
Wipe off the soiling on the printer surface with a dry soft
cloth with a weak neutral detergent. After that, wipe the
printer with a dry cloth.
7.2.2.
Setting paper
Fig. 1
1. Open the printer's cover door (3) by pulling it at the left
bottom corner (2).
1
3
2. Press the paper cover open button, and open the printer's
paper cover. Handle the paper cutter carefully not to cut
your hand.
3. Set a paper roll (5) as shown on Fig. 2.
4. Close the paper cover (9) by pressing both ends of the
cover (8) with the tip end of the paper (6) emerging
from the cutter (7).
9
Fig. 2
5. Close the printer's cover door (3) by pressing corner (2),
with the tip end of the paper emerging from the slot (1).
Page 37 of 56
Notes on treatment of the thermal papers:

Store the papers in a dry, cool and dark place.
Do not rub the papers with hard substance.
Keep the papers away from organic solvent.
Cautions
Never disassemble the printer. Failure to follow this instruction may
cause overheating or burning of the printer or the AC adapter. Or an
electric shock, which may lead to fires or accidents.
Never use the printer in a place of extreme humidity (more than 80%) or
any place where it can possibly be splashed by any liquids. If any liquids
get into the printer, it could lead to fire, electric shock, or other serious
accidents.
Never touch the thermal head immediately after printing because it
becomes very hot. Make sure that the thermal head is cool before setting
papers or cleaning the thermal head.
Page 38 of 56
8.
PREPARATION BEFORE STERILIZATION

The purpose of packaging and wrapping of items for sterilization is to provide
an effective barrier against sources of potential contamination in order to
maintain sterility and to permit aseptic removal of the contents of the pack.
Packaging and wrapping materials should permit the removal of air from the
pack, penetration of the sterilizing water vapor into the pack and removal of
the sterilizing vapor.
The basic principle determining the size, mass and contents of instrument and
hollowware packs is that the contents are sterile and dry immediately on
completion of the drying cycle and removal of the pack from the sterilizer
chamber.
Instruments to be sterilized must be clean, free from any residual matter, such
as debris, blood, pads or any other material. Such substances may cause
damage to the contents being sterilized and to the sterilizer.
Correct loading of the autoclave is essential for successful sterilization for
several reasons. Efficient air removal from the chamber and the load will
permit total steam penetration and saturation. Additionally, correct loading
will reduce damage to packs and their contents and maximize efficient use of
the sterilizer.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Immediately after use, clean instruments thoroughly to dispose any

residue.
It is recommended to wash instruments with an ultrasonic cleaner, using
detergent and mineral-free water.
Launder textile wraps prior to reuse.
After cleaning, rinse instruments for 30 seconds. (Follow manufacturers
instructions on the use of products for cleaning and lubricating
instruments after using the ultrasonic cleaner).
Materials, including materials used for inner wraps, shall be compatible
with the item being packed and the sterilizing method selected.
Before placing an instrument into the sterilizer tray, make sure that
instruments which are not of the same metal, (stainless steel, carbon
steel, etc.) are separated and placed on different trays.
Note:
Check manufacturers instructions for the sterilization of each item.
In case carbon steel instruments are placed on stainless steel trays, the
trays should be lined with a towel or paper wrap before placing the
instruments on the trays. There should be no direct contact between the
carbon steel and the stainless steel trays.

All instruments must be sterilized in an open position.
Page 39 of 56
10. Use single-use wraps only once and discards them after use.
11. Place a sterilization indicator strip in each tray.
12. Place instruments with ratchets opened and unlocked or clipped on the
first ratchet position.
13. Disassemble or sufficiently loosen multiple-part instruments prior to
packaging to permit the sterilizing agent to come into contact with all
parts of the instrument.
14. Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so
that only minimal resistance to removal of air, the passage of steam and
condensate will be met.
15. Load items within the boundaries of the tray so that they do not touch the
chamber walls, or fall off when the tray is in move.
16. Load trays loosely to capacity.
17. Once a week, use a biological spore test indicator in any load to make
sure sterilization is performed.
18. Make sure that all instruments remain apart during the sterilization cycle.
19. Empty canisters should be placed upside-down, in order to prevent
accumulation of water.
20. Allow a distance of approximately 2.5 cm (1) between trays to permit
steam circulation.
21. For proper sterilization - Do not overload the chamber
8.1.
Packs
1. Place packs upright on trays, side by side.
2. Packs should not touch the chamber walls.
3. Pack instrument sets in a manner that prevents damage to delicate
items.
4. Pack hollowware sets so that all openings face the same direction
and so that the contents cannot move inside the pack.
5. Load packs of folded operating room drapes with layers vertical,
allowing air to be removed from the packs rapidly.
6. Do not place packs of hollowware and trays of instruments above
textile packs or soft goods in order to avoid wetting caused by
condensation from items above.
7. Load items packed in flexible packaging materials on edge with
paper to laminate, or flat with the paper surface upwards.
Note:
The manufacturers recommendations shall be observed, concerning the
sterilization data for each type of material.
Page 40 of 56
8.2.
Tubing
When placing in a tray, Make sure that both ends are open, without
sharp bends or twists.
Wrong
Right
8.3.
Wrapped Instruments
1. Wrapped instruments should be packed in material that promotes
drying such as autoclave bag, autoclave paper.
2. It is highly recommended to utilize the Tuttnauer Pouch Rack.
This rack allows the operator to place pouches on their side, thus
increasing the capacity of the autoclave significantly and
promoting better drying of the instruments. Contact your dealer for
details.
3. Verify that the packaging method is in accordance with good

practice approach and the packaging materials are in accordance
with the applicable standards. We recommend using plastic-paper
pouches.
Page 41 of 56
9.
OPERATING INSTRUCTIONS
It is recommended to perform a B&D test cycle at the beginning of each
working day.
9.1.
Filling the Mineral-Free Water Reservoir.

1. Open the door (3).
2. Pour water, gently, into the front funnel (7) until it reaches the
required level (4) on the side gauge. It is preferable to use a carafe
Please note that the side gauge is divided into three sections. The bottom
red section (6) indicates that the water level in the reservoir is too low.
The middle blue section (4) shows that there is sufficient amount of
water. The upper red section (2) indicates that the water level in the
reservoir is too high. To assist the operator to detect the water level, the
water level gauge is equipped with a yellow float (5).
Caution!
Under no circumstance should water be filled above the top sign level
on the side gauge.
1
2
3
4
5
6
3. If the reservoir is empty, it is recommended to add water directly into

the reservoir, as follows:
Remove the water reservoir cover to reveal the water reservoir (1).
Pour distilled water into the reservoir through the opening on top of
the autoclave until it reaches the base of the safety valve holder (7).
L:\WORD-PLT\-4.doc
Caution:
Under no circumstance should water be filled above the

safety valve holder.
In case more water is added accidentally above the top sign level on the
side gauge, decrease the water level by draining the reservoir before
starting a cycle (see para. 10.2).
Caution: Use only water having the characteristics as per table in
para. 2.9. Tap water may clog the system and using them
can invalidate the manufacturers guarantee.
Page 42 of 56
9.2.
Turning on the autoclave

To start the system, press the main white switch (1) on the right side
of the autoclave.
1
In this stage the unit is heated to the operating temperature, (approx.
15 min). During the heating stage the preheating symbol
is
displayed. If beginning from cold autoclave, generator is not ready
symbol will be displayed
When the unit is ready the pre-heating symbol is replaced by the
next load number (see picture below).
9.3.
Opening the door

Place your thumb on the plastic cover of the locking unit (1) and the
other fingers in the handle (3).
Pull the handle (2) until the locking of the door is released.
Open the door.
1
9.4.
Loading
Load the autoclave properly according to instructions in chapter 9.
Compatible goods.
Do not overload.
9.5.
Operations
Hold the opening handle in open position, while pushing the door
until it comes to close position, then release the handle. (The open
door symbol
is replaced by the next load number).
Page 43 of 56
Select the program

UP key: next program
DOWN key: previous program
Verify that you choose the adequate cycle.
Start the cycle by pressing the START/STOP key
9.6.
Unloading
When the cycle ends the buzzer sounds continuously during 10
seconds and the message CYCLE END is displayed on the screen.
Open the autoclave's as follows:
Open the door the minimum required to let the residual steam to
escape from the chamber. Only after there is no vapor open the door
widely.
Warning
To avoid sever injuries from hot steam when opening the door:
It is strictly forbidden to lean on the autoclave.
It is strictly forbidden to place your hand or any part of your
body over the door.
Wear heat-resistant gloves or use the tray handle to remove the load
from the autoclave
On completion of the cycle, the load shall be visual inspected to
ascertain that the load is dry, and that sterilization indicators have
made the required color change.
9.7.
Stopping the process

It is possible to stop the program while the autoclave is in operating.
Pressing the START/STOP key at any stage of process, stops the
operation.
9.8.
Canceling the ERROR message

At the end of an aborted process, the error number, CYCLE FAIL
and a blinking warning symbol
are displayed on the screen. Refer
to "Displayed Error and Operational Messages".
Pressing the START/STOP key cancels the displayed message
number and enables opening the door.
Warning
The load has not completed a sterilization cycle, therefore it is not
sterile. Handle it as contaminated load.
9.9.
Sleep Mode
The autoclave has a sleep mode. If the autoclave has not been used for
4 hours and no key has been pressed during this period. In this mode all
outputs are turned off. To exit the "Sleep" status, press any pushbutton.
Page 44 of 56
10.
MAINTENANCE INSTRUCTIONS
10.1.
Preventive and Scheduled Maintenance

The maintenance operations described in this chapter have to be
fulfilled periodically to keep the device in good condition and to reduce
the breakdown time to a minimum.
The user can easily execute these operations in accordance with further
instructions.
The owner of the autoclave is responsible to order an authorized
technician to perform the periodical tests and preventive maintenance
operations, as specified in para. 10.1.3.2.
Use only mineral-free water as detailed in para. 2.9 (water quality).
10.1.1
Daily by the operator

Clean door gasket with a soft cloth. The gasket should be
clean and smooth.
10.1.2
Weekly by the operator

1. Check the interior of the autoclave. If the autoclave is
dirty it requires cleaning as follows:
Take out the tray holder and trays. Clean the tray
holder, trays and chamber's interior (especially its
bottom part) with a cleaning agent & water. Wipe off
the sediments from the chamber bottom with a sponge.
You may use diluted Chamber Brite solution as
cleaning agent. To prepare this solution, pour one bag
of Chamber Brite into 3/4 1 liter of warm mineralfree water. Immediately after cleaning, rinse the tray
holder, trays and chamber's interior with water to avoid
stains on the metal.
2.
Once a week clean and descale the chamber and the

reservoir using a cleaning agent as described above.
CAUTION:
Do not use steel wool or steel brush as this can damage
the chamber!
3.
4.
Clean the outer parts of the autoclave with a soft cloth.

Replace mineral free water in the reservoir.
If the autoclave was not used, drain the water from the
mineral free water reservoir once a week, and refill
with fresh mineral-free water or distilled water (see
para. 10.2).
5.
Once a week or when symbol

is displayed (the
shorter period) drain the water from the waste water
reservoir (see para. 10.2).
Page 45 of 56
10.1.3
Periodically
10.1.3.1 By the operator
1.
2.
3.
4.
10.1.3.2
Once a month, activate the safety valve (see

para. 10.5).
Once a month clean the strainer as per para.
10.6. Cleaning frequency may be reduced
according to experience.
Replace the air filter, every 6 months or after
1000 cycles (the shorter period) according to
para. 10.3.
Check the door gasket every 12 months and
replace it if required (see para. 10.4).
By a qualified technician
Every 6 months
Tighten the screws of the heaters and the
electrical connections at the heaters, valves and
connectors in the control box.
Drain the generator and refill with mineral free
water.
Once a year
Check the grounding continuity.
Calibrate the temperature and pressure.
Perform validation of the autoclave.
Check the precise operation of the earth leakage
relay.
Check the safety elements; safety valve, cut-off
thermostat, door locking mechanisms.
Check the operation sequences, the sterilization
parameters etc.
Check the water reservoir, piping, plastic parts
and electric wires.
Check and tightening the piping joints to avoid
leakage.
Check and tighten all screw connections in the
control box, heaters and valves and
instrumentation.
5 years
Check the door closing system for excessive
wear.
Performing safety tests: pressure vessel,
efficiency, electrical, according to local rules or
regulations.
To be perform only, by an authorized inspector.
Page 46 of 56
10.2.
Draining the Reservoirs

(Applies to the clean-water reservoir and to the waste-water reservoir)
1.
To drain the reservoir, use item (5) with the plastic hose (6)
attached to it (supplied with the autoclave).
2.
Insert part (5) into valve (3) and press it until you hear a click.
The drain valve is open.
3.
When the water reservoir is empty, press part (4). Item (5) will pop
out approx. 3mm and the drain valve will be closed. Remove item
(5) with the plastic tube.
4.
If the drained reservoir is the clean-water reservoir, fill reservoir

with distilled water until, reaches full level. (approximately 6.5
liters (1.72 gallons)).
The autoclave is now ready for use.
No.
description
Clean water drain
Waste water drain
Press this direction

to open drain valve
Press this direction

to close drain valve
Page 47 of 56
10.3.
Replacing the Air Filter

In order to break the vacuum, at the end of the dry phase, filtered
atmospheric air enters the chamber via a solenoid valve. The filtration of
the air is performed by the bacteriological filter that is placed at the inlet
of the chamber, through a solenoid valve.
The filter is mounted near an opening on the rear wall of the autoclave
enclosure, to ease access for replacing it.
To replace the filter proceed as follows:
1. Remove the filter cover (2), by turning the cover counterclockwise
until it is released.
2.
Remove the filter (3) from the filter cover by unscrewing the filter
from the filter cover.
3.
Cut the tie wrap (4) fixing the flexible tubing (5) connecting the filter
to the copper pipe, and pull off the filter.
4.
Replace the filter with a new one. Connect the filter (3) to the flexible
tubing (5) and tightening it with a tie wrap (4).
5.
Connect the filter to the filter cover by screwing the filter (3) into the
hole in the cover (1).
6.
Insert the filter to its place inside the autoclave and reassemble the
filter cover by turning it a turn clockwise. Verify that the cover is
fastened well in its place.
Page 48 of 56
10.4.
Replacing the Door Gasket

To avoid injuries replace the gasket while the autoclave is cold.
Pull off the gasket from the door groove and install the new gasket
referring to the drawings as above points 1, 2 and 3.
CAUTION!
See drawing below for the right direction of the gasket.
Autoclave's door
Door gasket
Page 49 of 56
10.5.
Checking the Safety Valve

(See "front view").
In order to prevent the safety valve from blockage, it is necessary to
allow the steam pressure to escape through it (every month).
The safety valves are located in the mineral-free water reservoir.
To avoid injuries begin this check while the autoclave is cold.
1
10.5.1
ASME-approved type safety valve

1.
Operate the sterilization cycle according to the manual.
2.
Allow a pressure of approximately 200 kPa (29-psi) to

build up in the generator and the chamber.
3.
Remove water reservoir cover (1).
4.
Pull the ring (4) of the safety valve using a tool, i.e.
screwdriver, hook etc. (3). Pull the safety valve ring for
2 seconds. Be careful not to burn your hands.
5.
Press the STOP key to stop operation, and exhaust steam

from chamber.
6.
Wait until pressure decreases to zero, only then can the

door be opened.
2
No.
1
2
3
4
Description
water reservoir cover
Safety valve
Pulling device
Pressure relief ring
Page 50 of 56
10.5.2
PED-approved type safety valve

1. Operate the sterilization cycle according to the manual.
2.
Allow a pressure of approx. 200 kPa (29-psi) to build up

in the generator and the chamber.
3.
Remove the water reservoir cover.
4.
Turn the pressure relief nut counterclockwise for 2

seconds. Verify steam escapes from the valve.
Attention:
Use protective gloves in order not to burn your hands with
the hot steam.
5.
Press the STOP key to interrupt the operation, and

exhaust steam from the chamber.
6.
Wait until the pressure decreases to zero, only then can

the door be opened.
No.
1
5
6
Description
water reservoir cover
Safety valve
pressure relief nut
Page 51 of 56
10.6.
Cleaning water strainer

CAUTION!
Before proceeding, Make sure that the electric cord is disconnected
and there is no pressure in the autoclave.
CAUTION!
Do not touch the strainer shortly after operation.
Touching the hot strainers cover may cause severe injuries.
If maintenance operation is performed while strainer cover is hot,
use heat resistant gloves to avoid injuries.
1.
Open the door.
2.
Remove the trays and the trays holder.
3.
Remove the strainer element mounted on the bottom-rear of the

chamber.
4.
Rinse the strainer with water using a brush if necessary.
5.
Reinstall the strainer element.
6.
Reinstall the trays holder and the trays.
Strainer element
The strainer element is located

on the back of the chamber
Page 52 of 56
10.7.
Emergency opening of the door

If there is no power supply while the autoclave is closed and it is
required to open the door, proceed as follows:
1. Wait at least one hour until the autoclave cools down.
2. Verify that there is no pressure in the autoclave by activating the
safety valve (pulling the ring or turning the nut as appropriate).
3. Insert a pin (1) into the hole (2) in the handle.
4. Open the door.
1
2
Page 53 of 56
11.
TROUBLESHOOTING
Only technical personnel having proper qualifications and holding
technical documentation (including a technician manual) and adequate
information are authorized to service the apparatus.
Problem
Display is not
activated
The printer
does not print
Solution
Verify that the main switch is in the On position.
Make sure the power cord is properly connected to the

machine and the power source.
Verify that there is electrical power in the main source.
If the problem persists, contact your dealer or point of

purchase for further assistance.
Make sure the paper is inserted in the printer.
Switch off the machine and switch it back on. If the

printer prints a test printout, the printer is O.K.
If the printer does not print the test printout, contact

your dealer to solve the problem.
Page 54 of 56
TRAY HANDLE
CMT240-0001
POUCH RACK
ACS215-0008
TRAY
TRY240-0001
TRAY HOLDER
TRH254-0001
Page 55 of 56
12.
SPARE PARTS LIST

PART NUMBER
13.
DESCRIPTION
FIL175-0042
Filter, Air, 0.2 Micron, Model 50mm D
THE002-0010
Paper, Roll, Printer DPU30
ACCESSORIES
PART NUMBER
DESCRIPTION
ACS215-0008
Pouch rack
CMT240-0002
Handle, Tray
GAS084-0007
Drain P.V.C. Tube, 8x12
THE002-0022
Printer, DPU-30, Seiko
TRH254-0001
Holder, Tray 11"
WIR040-0002
Cable, Electric, Plug + Socket 230V 10A, EUR
Page 56 of 56

ELARA11 Operation

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OPERATION

Cat. No. MAN205-0342002EN Rev A

INCOMING INSPECTION ........................................................................... 4

2. SAFETY INSTRUCTIONS .................................................................................... 6

INTENDED USE ......................................................................................... 7

DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD ..... 17

5. STERILIZATION PROGRAMS ......................................................................... 22

PROGRAM 1: FLASH 134........................................................................ 23

6. MONITORING AND CHANGING PARAMETERS AND OTHER DATA .. 31

PRINTER OUTPUT .................................................................................. 35

8. PREPARATION BEFORE STERILIZATION.................................................. 39

9. OPERATING INSTRUCTIONS .......................................................................... 42

FILLING THE MINERAL-FREE WATER RESERVOIR. ............................ 42

10. MAINTENANCE INSTRUCTIONS ................................................................... 45

PREVENTIVE AND SCHEDULED MAINTENANCE .................................... 45

11. TROUBLESHOOTING ........................................................................................ 54

No products will be accepted for repair without proper authorization

All autoclave users must receive training in proper usage from an

ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN

Max. Allowable Working Pressure

Distance between supporting legs

Maximum load per item

2.8 bar (40 psi)

Weight per support area (max. load)

6.6 lit. (1.74 US gal)

Mineral free water

See table in para 3.10.

Environment Emission Information

The total heat per hour transmitted by the autoclave is <200Wh.

Protection against electrical shock

Class I (IEC 60601-1)

Mains supply fluctuation

In order to avoid any injury by electrical hazard, it is

Caution! Hot surface.

Caution! Hot steam.

Protective earth (Ground)

Compliance with the above data should be tested in accordance

Directives and Standards

EN 13060:2004 Small Steam Sterilizers.

ASME Code, section VIII division 1 for pressure

EN 61326, Electrical equipment for measurement,

UL/IEL/EN 61010-1 electrical

UL/IEL/EN 61010-2-040 particular requirements for

The following standards were taken in consideration:

ISO 17665-1:2006 specifies requirements for the

EN ISO 9001:2008 Quality System

ISO 13485:2003 Quality systems Medical devices.

Water reservoir funnel

Operating key board

Water level side gauge

Mineral-free water reservoir cover

Waste water reservoir drain valve

Waste water reservoir cover

Mineral-free water reservoir drain

Main switch circuit breaker

Door closing device

Mineral-free water reservoir cover

Waste water reservoir cover

Air filter service cover

Opening for calibration

Main power electric cable socket

Description and Functions of the Front Panel Keyboard

Displayed Error and Operational Messages

This message and symbol are