OPERATION

&
MAINTENANCE
MANUAL
Pre-vacuum Table–top Autoclave

Model ELARA

Cat. No. MAN205-0342001EN Rev D

 Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540

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 TABLE OF CONTENT
1. GENERAL................................................................................................................ 4
1.1. INCOMING INSPECTION ................................................................................... 4
1.2. WARRANTY ..................................................................................................... 4
1.3. WARRANTY STATEMENT ................................................................................ 4
2. SAFETY INSTRUCTIONS .................................................................................... 6
3. GENERAL INFORMATION ................................................................................. 7
3.1. INTENDED USE ................................................................................................ 7
3.2. INTRODUCTION ............................................................................................... 7
3.3. OPERATING CONDITIONS ............................................................................... 8
3.4. SPECIFICATIONS .............................................................................................. 9
3.5. UTILITIES ...................................................................................................... 10
3.6. ENVIRONMENT EMISSION INFORMATION .................................................... 10
3.7. ELECTRICAL DATA ....................................................................................... 10
3.8. CONSTRUCTION............................................................................................. 11
3.9. SYMBOL DESCRIPTION ................................................................................. 11
3.10. WATER QUALITY .......................................................................................... 12
3.11. DIRECTIVES AND STANDARDS ...................................................................... 13
4. KEYBOARD .......................................................................................................... 16
4.1. DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD ............ 17
4.2. DISPLAYED ERROR AND OPERATIONAL MESSAGES .................................... 19
5. STERILIZATION PROGRAMS ......................................................................... 22
5.1. PROGRAM 1: FLASH 134 ............................................................................... 23
5.2. PROGRAM 2: P 134........................................................................................ 24
5.3. PROGRAM 3: WDRY 134............................................................................... 25
5.4. PROGRAM 4: NODRY 121 ............................................................................. 26
5.5. PROGRAM 5: WDRY 121 ............................................................................... 27
5.6. PROGRAM 6: DELICATE 121 ......................................................................... 27
5.6. PROGRAM 6: DELICATE 121 ......................................................................... 28
5.7. TEST 1: B&D TEST ....................................................................................... 29
5.8. TEST 2: VACTEST ......................................................................................... 30
6. MONITORING AND CHANGING PARAMETERS AND OTHER DATA .. 31
6.1. MENU............................................................................................................. 31
6.2. PARAMETERS ................................................................................................ 32
6.3. SETTING THE CLOCK .................................................................................... 33
6.4. HISTORY ........................................................................................................ 34
7. PRINTER................................................................................................................ 35
7.1. PRINTER OUTPUT .......................................................................................... 35
7.2. PRINTER HANDLING ..................................................................................... 37
8. INSTALLATION................................................................................................... 39
8.1. PLACING ........................................................................................................ 39
8.2. LIFTING AND CARRYING ............................................................................... 39
8.3. FILLING THE MINERAL-FREE WATER RESERVOIR..................................... 40
9. PREPARATION BEFORE STERILIZATION.................................................. 41
9.1. PACKS ............................................................................................................ 42
9.2. TUBING .......................................................................................................... 43
9.3. WRAPPED INSTRUMENTS .............................................................................. 43

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 10. OPERATING INSTRUCTIONS .......................................................................... 44
10.1. TURNING ON THE AUTOCLAVE...................................................................... 44
.10.2 OPENING THE DOOR ...................................................................................... 44
.10.3 LOADING ....................................................................................................... 44
10.4. OPERATIONS ................................................................................................. 45
10.5. UNLOADING ................................................................................................... 45
10.6. STOPPING THE PROCESS................................................................................ 45
10.7. CANCELING THE ERROR MESSAGE ............................................................ 45
10.8. SLEEP MODE ................................................................................................. 45
11. MAINTENANCE INSTRUCTIONS ................................................................... 46
11.1. PREVENTIVE AND SCHEDULED MAINTENANCE ........................................... 46
11.2. DRAINING THE RESERVOIRS ......................................................................... 48
11.3. REPLACING THE AIR FILTER ........................................................................ 49
11.4. REPLACING THE DOOR GASKET .................................................................. 50
11.5. CHECKING THE SAFETY VALVE ................................................................... 51
11.6. CLEANING WATER STRAINER ....................................................................... 53
12. TROUBLESHOOTING ........................................................................................ 54
13. SPARE PARTS LIST ............................................................................................ 56
14. ACCESSORIES ..................................................................................................... 56

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 TABLE OF ILLUSTRATIONS

FRONT VIEW ...........................................................................................................14

REAR VIEW ..............................................................................................................15
TRAY HANDLE ........................................................................................................55
POUCH RACK ..........................................................................................................55
TRAY ..........................................................................................................................55
TRAY HOLDER........................................................................................................55

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 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 11. (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: [email protected].

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 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).
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.

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 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. 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.
2. Before use, check inside the autoclave chamber to ensure that no items
have been left from the previous cycle.
3. Load trays in such a way as to allow steam to move freely among all items.
4. 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.
5. Individual glass bottles shall be placed on a tray.
6. On closing the device door, make sure it is properly locked before
activating. Verify that DOOR OPEN symbol is replaced by the load
number.
7. Verify once again that you have chosen the appropriate sterilization
program.
8. Before withdrawing trays, wear heat resistant gloves.
9. Before opening the door, verify that there is no pressure in the chamber
(chamber pressure is displayed on the screen).
10. Open the door slowly to allow steam to escape and wait 1 minute before
you remove the load.
11. Once a month, ensure that the safety valve is operating, and once a year
certified inspector must perform pressure chamber safety test.
12. Once annually, or more frequently, effective tests must be performed, i.e.,
calibration and validation.
13. Make sure there are no leaks, breaks, blockages, whistles or strange noises.
14. Perform maintenance operations as instructed. The owner of the
autoclave is responsible to perform the maintenance operations.
15. Notify the person in charge immediately of any deviation or risk for the
proper function of the device.
16. Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or
rules!

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 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 goods that are defined as hollow A 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 and
ST55.
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 operator’s 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 service the apparatus.

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 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
5ºC-40ºC 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!

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 3.4. Specifications

Overall Dimensions
Front View Top View

Property Value
Max. Allowable Working Pressure (MAWP) 2.8 bar (40 psi)
Diameter 280 mm (11”)
Chamber
Depth 504 mm (19.8”)
Chamber volume 28.5 lit. (7.5 gal)
Width (A) 530 mm (20.8”)
Height (B) 444 mm (17.4”)
External dimensions Length (C) 645 mm (25.4”)
Length with
950 cm (36.6”)
open door (D)
Distance between supporting legs K 452 mm (17.8”)
F - rear legs F 315 mm (12.4”)
F1 - front legs F1 400 mm (15.7”)
Maximum load per item 0.5 kg (1.1 lb)
Maximum load per tray 2.0 kg (4.4 lb)
Maximum solid load 8.0 kg (17.6 lb)
Maximum textile load 2.0 kg (4.4 lb)
W 212 mm (8.3”)
Tray dimensions H 21 mm (0.8”)
L 350 mm (13.7”)
No. of trays 5
IMS cassettes (optional) 4

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 Property Value
Weight 66 kg (145.5 lb)
1.71 N/m2
Weight per support area (max. load)
(0.036 lb/ft2)
Shipping weight 71 kg (156 lb)
Width 63 cm (24.8”)
Height 71 cm (28.0”)
Shipping dimensions
Length 80 cm (35.8”)
Volume 0.36 m3 (14.5 ft3)
Max. water
6.6 lit. (1.74 US gal)
volume
Mineral-free water reservoir
Min. water
2.6 lit. (0.68 US gal)
volume
Max. water
Used (waste) water reservoir 5.2 lit. (1.37 US gal)
volume

3.5. Utilities
Utility Value
Mineral free water See table in para 3.10.
Power supply 1 phase, 208/240Vac, 50/60Hz
Recommended circuit breaker 15A

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. The total heat per hour transmitted by the autoclave is <200Wh.
3.7. 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%

Note:
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).

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 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 316.
• 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)

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 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 water or steam, for steam generator and sterlizers
(According to EN 285:2006).

1.1.1.2 Contamin
Contami ants in
nants in water condensate
supplied to at steam
generator inlet to
chamber
≤ 10
Evaporate residue N/A
mg/l
≤1 ≤ 0.1
Silicate (SiO2
mg/l mg/l
≤ ≤
Iron
0.2mg/l 0.1mg/l
≤ 0 ≤
Cadmium
0.005 mg/l 0.005 mg/l
1 ≤ 0.05 2 ≤ 0.05
Lead
mg/l mg/l
Rest of heavy metals except 3 ≤ 0.1 4 ≤ 0.1
iron, cadmium, lead mg/l mg/l
5 ≤2 6 ≤2
Chloride (Cl)
mg/l mg/l
7 ≤ 0.5 8 ≤ 0.5
Phosphate (P2O5)
mg/l mg/l
9 ≤ 15 0 ≤3
Conductivity (at 25°C)
µs/cm µs/cm
1 5 to
pH value (degree of acidity) 2 5 to 7
7.5
Hardness (Σ ions of alkaline 3 ≤ 0.02 4 ≤ 0.02
earth) mmol/l mmol/l
5 Colourless, clean, without
Appearance
sediments

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 manufacturer’s guarantee.

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 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 equipment for
laboratory use; general requirements
5. UL/IEL/EN 61010-2-041 particular requirements for
autoclaves using steam for the treatment of medical
materials and for laboratory processes
6. UL/IEL/EN 61010-2-040 particular requirements for
sterilizers and washer disinfectors used to treat medical
materials.
The following standards were taken in consideration:
7. EN 554 Sterilization of Medical Devices - Validation
and Routine Control of Sterilization by Moist Heat
8. ISO 13683 Sterilization of Health Care Products -
Requirements for Validation and Routine Control of
Moist Heat Sterilization in Health Care Facilities

3.11.2. Quality standards

The manufacturing plant meets the following quality
standards:
1. EN ISO 9001:2000– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices –
Particular requirements for the application of ISO 9001.

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 FRONT VIEW

1 2 3 4 5 6

18 7

17 8

16 9

13 15 14 13 12 11 10

No. Description No. Description

1 Water reservoir funnel 10 Operating key board

2 Autoclave cover 11 Printer cover
3 Water level side gauge 12 Printer (option)
4 Mineral-free water reservoir cover 13 Legs
Chamber and steam generator safety
5 14 Waste water reservoir drain valve
valves
Mineral-free water reservoir drain
6 Waste water reservoir cover 15
valve
7 Display 16 Door cover
8 Ventilation grill 17 Door switch
9 Main switch circuit breaker 18 Door closing device

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 REAR VIEW

6 3

No. Description

1 Mineral-free water reservoir cover

2 Waste water reservoir cover
3 Ventilation grills
4 Air filter service cover
5 Opening for calibration
6 Main power electric cable socket

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 4. KEYBOARD

No. Description
1 Display
2 Keypad
3 Printer

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 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

Time display:
― Clock
― Time countdown
 Load number
or
 Error and operational
messages

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 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
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 DOWN ▼ key decreases its value.
o When the cursor is blinking on a word, the
DOWN ▼ key enables to move ahead or to
browse through the directories.
START/STOP key
This key has the following functions:
• 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.
• In the directories available:
o When the cursor is blinking on a number,
the START/STOP key enables to move
ahead.
o When the cursor is blinking on a word, the
START/STOP key enables to enter in
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.

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 4.2. Displayed Error and Operational Messages

Error Error
Message Description Corrective Action
Number Name
Err:001 Pt1 out This message and symbol are Call the technician.
displayed when the Chamber
Temperature sensor Pt1 is
disconnected or out of range.
Err:002 Low This message displayed when Check that the
Temperature the temperature drops for autoclave is not
more than 1 second below the overloaded or check
sterilization temperature. leakage from the
door.
If the problem
persist, call the
technician.
Err:003 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 3°C (6°F)
above sterilization temperature
during the sterilization stage
for 10 seconds.
Err:005 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.
Err:007 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.
Err:008 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.
Err:009 Time Error This message displayed if the Call the technician.
real time clock is faulty.
Err:011 Door is This message displayed when Call the technician.
Open the door is open during the
cycle.
Err:012 Manual This message displayed after
Stop the STOP key is pressed and
cycle aborted.

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 Error Error
Message Description Corrective Action
Number Name
Err:013 Air Valve Message is displayed when the Replace air filter.
Error system can't reach the
atmosphere pressure in the
chamber by opening Air Valve
for 3 minutes.
Err:014 Low The message displayed if the Verify that the door
Vacuum system can't reach the required is properly closed.
vacuum conditions in the Perform a new
chamber for 20 minutes. cycle.
If the problem
persists, call the
technician.
Err:015 Low Heat 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.
Err:016 Press This message and symbol are Call the technician.
Sensor displayed if the chamber
Cutout pressure sensor is
disconnected or out of range.
Err:017 Pt2 out This message and symbol are Call the technician.
displayed when the Jacket
Temperature sensor Pt2 is
disconnected or out of range.
Err:018 Press This message and symbol are Call the technician.
Sensor displayed if steam generator
Cutout pressure sensor is disconnected
or out of range.
Err:020 No Gen This message is displayed if Perform a new
water the generator electrode has no cycle .
water for a specific time. If the problem
persists, call the
technician.
Err:021 Test Fail This message is displayed if Check the leakage
one of the test programs fails. from the door.
Dry the chamber and
try a second time.
This message is displayed if Pour water in the
there is lack of water in the front funnel until it
mineral-free water reservoir. reach the full level.
This message is displayed if 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.

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 Error Error
Message Description Corrective Action
Number Name
The autoclave's door is open. Close the door to
perform a new
cycle.
The generator is not ready. Wait for the
generator to create
steam.

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 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:

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.

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 5.1. Program 1: Flash 134

Program 1 is recommended for sterilizing unwrapped instruments, at

temperatures of 134ºC/273ºF 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: 134ºC (273ºF).
• 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

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 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 134ºC/273ºF with 20 minutes 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).

The porous load shall not exceed 2kg (4.4 lb).
Nominal parameters
• Sterilization temperature: 134ºC (273ºF).
• Sterilization time: 18 minutes.
• Dry time: 20 minutes.
• Max. cycle time: 55 minutes.
• Average cycle time: 48 minutes.

Operation Sequence
• Air removal phase; three 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,
followed by a continuous vacuum pulse for the drying stage,
followed by vacuum break (air inlet) until pressure equalizes
atmospheric pressure.

0 9 18 27 36 45 54

Cycle start Cycle end

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 5.3. Program 3: WDry 134

Program 3 is recommended for sterilizing double wrapped instruments,

porous loads and Hollow A (e.g. dental hand pieces, suction pipes)
loads at temperatures of 134ºC / 273ºF with 20 minutes 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).

The porous load shall not exceed 2kg (4.4 lb).
Nominal Parameters
• Sterilization temperature: 134ºC (273ºF).
• Sterilization time: 4 minutes.
• Dry time: 20 minutes.
• Max. cycle time: 50 minutes.
• Average cycle time: 42 minutes.

Operation Sequence
• Air removal phase; three 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,
followed by a continuous vacuum pulse for the drying stage,
followed by vacuum break (air inlet), until pressure equalizes
atmospheric pressure.

Cycle start Cycle end

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 5.4. Program 4: NoDry 121

Program 4 is recommended for sterilizing unwrapped instruments at a

temperature of 121ºC / 250ºF without 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: 121ºC (250ºF).
• Sterilization time: 20 minutes.
• Max. cycle time: 40 minutes.
• Average cycle time: 35 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

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 5.5. Program 5: Wdry 121

Program 5 is recommended for sterilizing double wrapped instruments,

porous loads and Hollow A (e.g. dental hand pieces, suction pipes)
loads at temperatures of 121ºC/250ºF with 20 minutes 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).

The porous load shall not exceed 2kg (4.4 lb).
Nominal Parameters
• Sterilization temperature: 121ºC (250ºF).
• Sterilization time: 20 minutes.
• Dry time: 20 minutes.
• Max. cycle time: 70 minutes.
• Average cycle time: 60 minutes.

Operation Sequence
• Air removal phase; three 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
and drying stage is performed with a continuous vacuum pulse,
followed by vacuum break (air inlet), until pressure equalizes
atmospheric pressure.
5.6.

Cycle start Cycle end

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 Program 6: Delicate 121

Program 6 is recommended for sterilizing delicate instruments at

temperatures of 121ºC/250ºF with slow exhaust, 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: 121ºC (250ºF).
• Sterilization time: 20 minutes.
• Max. cycle time: 55 minutes.
• Average cycle time: 45 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.
• Slow exhaust phase; steam is slowly exhausted from the chamber
by pulses of the exhaust valve, until the pressure equals the
atmospheric pressure.

Cycle start Cycle end

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 5.7. Test 1: B&D Test

Test 1 is the Bowie & Dick test program, with fixed sterilization
parameters 134ºC and 3.5mins, which cannot be modified by the
operator or the technician.

Nominal parameters
• Sterilization temperature: 134ºC
• Sterilization time: 3.5 minutes.
• Dry time: 1 minute.
• Max. cycle time: 30 minutes.
• Average cycle time: 25 minutes.

Operations Sequence
• Air removal phase; three 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 134ºC 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

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 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

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 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.

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 6.2. Parameters
This directory enables the operator to watch and change the cycle’s
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. To move the curser from one digit to another press the

START/STOP key.
2. Use the UP and DOWN keys to increase or decrease the current
digit.
3. 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.
4. 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.
5. If, by mistake, the curser skipped the SET and reached EXIT,
continue to press START/STOP until the curser returns to SET.

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 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.

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 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.

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 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.

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 PRINTER OUTPUT DESCRIPTION

Operator: To be filled in manually by operator

Time: 17:09:08 Time sterilization cycle ended

Date: 13/02/2006 Date sterilization cycle ended.
CYCLE ENDED!
D 00:48:46 077.4 036.2 The time, temperature and pressure during drying.
*
* Prints drying data every 3 minutes.
*
D 00:30:46 104.8 109.2 The time, temperature and pressure during drying.
-----------------------
E 00:30:07 122.0 211.6 The time, temperature and pressure during exhaust.
-----------------------
S 00:30:07 134.1 311.3 The time, temperature and pressure during sterilization.
*
* Prints sterilization data every 1 minute.
*
S 00:10:06 121.1 210.0 The time, temperature and pressure during sterilization.
----------------------
H 00:08:57 077.4 058.3 The time, temperature and pressure during heating.
----------------------
V 00:08:57 077.4 058.3 The time, temperature and pressure during air removal.
*
Prints sterilization data every 3 minute or on upper and
*
lower peak (the shorter time)
*
V 00:00:00 078.1 095.0 The time, temperature and pressure during air removal.
Time °C kPa Time, temperature and pressure columns
Dry Time: 020.0min Drying time for selected program.
Ster Time: 020.0min Sterilization time for selected program.
Ster Temp: 121.0°C Sterilization temperature in chamber for selected program
Cycle: WDry Cycle name (with dry).
Load number: 00933 Cycle counter
Param. Ver: 0030 Version of parameters setting
Ver: Nova 4 1.20 Software version.
Ser.Num: 02304101 Autoclave's serial number.
Time: 16:18:22 Time sterilization cycle started.
Date: 13/02/2006 Date sterilization cycle started.
POWER ON The device is turned on
Time: 16:16:16 Start time
Date: 13/02/2006 Start date
POWER OFF The device is turned off
--------------------
Legend

V Vacuum stage E Exhaust stage

H Heating stage D Drying stage
S Sterilization stage T Test

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 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).

3
2
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

4 5 6 7 6
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).

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 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.

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 8. INSTALLATION
8.1. Placing
CAUTION:
The sterilizer must be placed on a rigid and leveled surface. The
stand must be able to withstand the load of the device and loaded
material.
1. Counter top able to support 80 kg.
2. Counter space minimum 55cmW x 65cmD (22”W x 25”D)
* (see unit dimensions)
8.1.1 Placing the Autoclave
Keep the back and the sides of the autoclave approximately
50 mm (2”) away from the wall to allow ventilation and to
facilitate the device disconnection.
If placed in a cabinet, verify that the rear of the cabinet is
open to allow ventilation.
Insufficient space for ventilation may result in an increase
of the autoclave's temperature that may damage the
instrument.
It is recommended that enough space be left around the
autoclave to give a technician access for servicing the
machine.
8.1.2 Connections to Utility Supplies
Plug the power cord into the 1 phase, 208/240Vac,
50/60Hz, 10A supply.

8.2. Lifting and carrying

CAUTION:
Before moving the autoclave, Make sure that the electric cord is
disconnected from the power, and there is no pressure in the
chamber and in the generator.

Attention! The pressure of the generator does not decrease

immediately when the equipment is turned off. Wait approx. ½ an
hour to verify that the pressure decreased to atmospheric pressure.
1. Disconnect the power supply cord.
2. Drain the water from both reservoirs.
To avoid injuries, lifting and carrying should be done with at least two
persons or by using a fork-lift or any other mechanical aid.
Do not drop the device!

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 8.3. Filling the Mineral-Free Water Reservoir.
1. Open the door (1).
2. Pour water, gently, into the front funnel (2) until it reaches the
required level (3) 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 (4) indicates that the water level in the reservoir is
too low. The middle blue section (3) shows that there is sufficient
amount of water. The upper red section (2) indicates that the water
level in the reservoir is too high.
Caution!
Under no circumstance should water be filled above the top sign
level on the side gauge.

3
5

3. If the reservoir is empty, it is recommended to add water directly

into the reservoir, as follows:
♦ Remove the water reservoir cover (6).
♦ 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).
7 6C

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. 11.2).
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
manufacturer’s guarantee.

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 9. 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. Immediately after use, clean instruments thoroughly to dispose any
residue.
2. It is recommended to wash instruments with an ultrasonic cleaner, using
detergent and mineral-free water.
3. Launder textile wraps prior to reuse.
4. After cleaning, rinse instruments for 30 seconds. (Follow manufacturer’s
instructions on the use of products for cleaning and lubricating
instruments after using the ultrasonic cleaner).
5. Materials, including materials used for inner wraps, shall be compatible
with the item being packed and the sterilizing method selected.
6. 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:
7. Check manufacturer’s instructions for the sterilization of each item.
8. 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.

9. All instruments must be sterilized in an open position.

10. Use single-use wraps only once and discards them after use.

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 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

9.1. 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 manufacturer’s recommendations shall be observed, concerning the
sterilization data for each type of material.

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 9.2. Tubing
When placing in a tray, Make sure that both ends are open, without
sharp bends or twists.

Wrong

Right

9.3. 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.

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 10. OPERATING INSTRUCTIONS
It is recommended to perform a B&D test cycle at the beginning of each
working day.

10.1. Turning on the autoclave

• To start the system, press the main white switch (1) on the right side
of the autoclave.

• 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).

10.2. 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
3

10.3. Loading
• Load the autoclave properly according to instructions in chapter 9.
ƒ Compatible goods.
ƒ Do not overload.

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 10.4. 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).
• Select the program
ƒ UP key: next program
ƒ DOWN key: previous program
• Verify that you choose the adequate cycle.
• Start the cycle by pressing the START/STOP key

10.5. 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.

10.6. 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.

10.7. 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.

10.8. 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 push-
button.

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 11. MAINTENANCE INSTRUCTIONS
11.1. 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. 11.1.3.2.
Use only mineral-free water as detailed in para. 2.9 (water quality).

11.1.1 Daily by the operator

Clean door gasket with a soft cloth. The gasket should be
clean and smooth.

11.1.2 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 mineral-
free 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. Clean the outer parts of the autoclave with a soft cloth.
4. 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. 11.2).
5. Once a week or when symbol is displayed (the
shorter period) drain the water from the waste water
reservoir (see para. 11.2).

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 11.1.3 Periodically
11.1.3.1 By the operator
1. Once a month, activate the safety valve (see
para. 11.5).
2. Once a month clean the strainer as per para.
11.6. Cleaning frequency may be reduced
according to experience.
3. Replace the air filter, every 6 months or after
1000 cycles (the shorter period) according to
para. 11.3.
4. Check the door gasket every 12 months and
replace it if required (see para. 11.4).

11.1.3.2 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.

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 11.2. 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
1 Clean water drain
2 Waste water drain

Press this direction

to open drain valve

3 4 5 6
Press this direction
to close drain valve

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 11.3. 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 ¼ turn clockwise. Verify that the cover is
fastened well in its place.

5 4 3 2

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 11.4. 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

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 11.5. 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.

11.5.1 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 3 4

No. Description
1 water reservoir cover
2 Safety valve
3 Pulling device
4 Pressure relief ring

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 11.5.2 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 clockwise 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.

5 6

No. Description
1 water reservoir cover
5 Safety valve
6 pressure relief nut

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 11.6. 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 strainer’s 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

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 12. 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 Solution
Display is not • Verify that the main switch is in the ‘On’ position.
activated
• 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.
The printer • Make sure the paper is inserted in the printer.
does not print
• Switch off the machine and switch it back on while
pressing the feed button on the printer. If the printer
prints a test printout, the printer is O.K. and there is a
problem with the electronics. Contact the dealer to solve
the problem.
• If the printer does not print the test printout, there is a
problem with the printer. Contact your dealer to solve
the problem.

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 TRAY HANDLE
CMT240-0001

POUCH RACK
ACS215-0008

TRAY
TRY240-0001

TRAY HOLDER
TRH254-0001

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 13. SPARE PARTS LIST

PART NUMBER DESCRIPTION

FIL175-0042 Filter, Air, 0.2 Micron, Model 50mm D
THE002-0010 Paper, Roll, Printer DPU30

14. ACCESSORIES

PART NUMBER DESCRIPTION

ACS215-0008 Pouch rack
CMT240-0001 Handle, Tray
GAS084-0007 Drain P.V.C. Tube, 8x12
THE002-0009 Printer, DPU30
TRH254-0001 Holder, Tray 11"
WIR040-0002 Cable, Electric, Plug + Socket 230V 10A, EUR

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