Tuttnauer 5075 GS-2A User manual

Operation and Maintenance Manual
Cat. No. MAN205-1000000EN Rev B
Tuttnauer Europe B.V.,
Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda,
The Netherlands Tel: [phone], Fax: [phone]
Pre-vacuum Steam Sterilizer with Generator
Model 5075 GS-2A, 50125 GS-2A

Operation and
Maintenance Manual
Pre-vacuum Steam Sterilizer with
Generator
Cat. No. MAN205-1000000EN Rev B
Tuttnauer Europe B.V.,
Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda,
The Netherlands Tel: [phone], Fax: [phone]
Model 5075 GS-2A, 50125 GS-2A

https://tuttnauer.com/

Page 1
TABLE OF CONTENTS
1. GENERAL ................................................................................................................................... 3
1.1. INCOMING INSPECTION................................................................................................................ 3
1.2. WARRANTY DESCRIPTION ............................................................................................................3
1.3. WARRANTY STATEMENT .............................................................................................................. 3
2. SAFETY INSTRUCTIONS .............................................................................................................4
2.1. SAFETY FEATURES ....................................................................................................................... 4
2.2. SAFETY INSTRUCTIONS................................................................................................................. 4
2.3. OPERATING CONDITIONS .............................................................................................................5
3. GENERAL INFORMATION .......................................................................................................... 5
3.1. INTRODUCTION .......................................................................................................................... 5
3.1. FRONT PANEL AND REAR PANEL .................................................................................................... 6
3.2. SPECIFICATION ........................................................................................................................... 7
3.3. GENERATOR'SSTEAM DATA .........................................................................................................7
3.4. GENERATOR'SELECTRICAL DATA ...................................................................................................7
3.5. AUTOCLAVE'SELECTRICAL DATA (THE GENERATOR IS NOT INCLUDED) .................................................. 7
3.6. UTILITIES .................................................................................................................................. 8
3.7. ENVIRONMENTAL EMISSION INFORMATION ..................................................................................... 8
3.8. CONSTRUCTION.......................................................................................................................... 8
3.9. STICKERS DESCRIPTION ................................................................................................................ 9
3.10. WATER QUALITY ........................................................................................................................ 9
3.11. DIRECTIVES AND STANDARDS ......................................................................................................10
3.12. OVERALL DIMENSIONS 5075GS-2A............................................................................................ 11
3.13. OVERALL DIMENSIONS 50125GS-2A.......................................................................................... 12
3.14. REAR PANEL UN-LOADING (“CLEAN”) SIDE VIEW -- 5075GS-2A ..................................................... 13
3.15. FRONT PANEL LOADING (“DIRTY”) SIDE VIEW – 5075GS-2A .......................................................... 14
3.16. REAR PANEL UN-LOADING (“CLEAN”) SIDE VIEW -- 50125GS-2A ................................................... 15
3.17. FRONT PANEL LOADING (“DIRTY”) SIDE VIEW – 50125GS-2A ........................................................ 16
4. CONTROL PANEL ..................................................................................................................... 17
4.1. DESCRIPTION AND FUNCTIONS OF THE CONTROL PANEL ................................................................... 17
4.2. DISPLAYED ERROR MESSAGES / SYMBOLS ..................................................................................... 20
4.3. DISPLAYED OPERATIONAL MESSAGES/ SYMBOLS ............................................................................ 20
5. STERILIZATION PROGRAMS..................................................................................................... 21
5.1. PROGRAM PARAMETERS ............................................................................................................ 21
5.2. CYCLE PROCESS DESCRIPTION .....................................................................................................22
5.3. VACUUM TEST PROCESS DESCRIPTION.......................................................................................... 22
5.4. BOWIE AND DICK TEST PROCESS DESCRIPTION ............................................................................... 22
6. INSTALLATION INSTRUCTION .................................................................................................. 22
6.1. PLACING ................................................................................................................................. 22
6.2. SETUP .................................................................................................................................... 22
6.3. UTILITIES CONNECTION .............................................................................................................. 23
6.4. LIFTING AND CARRYING .............................................................................................................23
6.5. GENERATOR ............................................................................................................................ 23
7. PREPARATION BEFORE STERILIZATION. LOADING ................................................................... 24
7.1. GENERAL RULES TO BE CONSIDERED: ............................................................................................ 24
7.2. PACKS .................................................................................................................................... 25
7.3. TUBING ..................................................................................................................................26
7.4. WRAPPED INSTRUMENTS ........................................................................................................... 26
7.1. LOADING ................................................................................................................................ 26
8. OPERATING INSTRUCTIONS .................................................................................................... 27
8.1. WATER SUPPLY........................................................................................................................ 27
8.2. TURNING ON THE AUTOCLAVE..................................................................................................... 27

Page 2
8.3. STARTING A CYCLE .................................................................................................................... 28
8.4. MALFUNCTIONS (STOP BY USER OR CONTROLLER) .......................................................................... 30
8.5. CYCLE END.............................................................................................................................. 32
8.6. ABORTING A CYCLE ................................................................................................................... 33
8.7. ENDING THE CYCLE. UNLOADING................................................................................................. 33
8.8. STOPPING THE PROCESS DUE TO CYCLE FAILURE ............................................................................. 35
9. CHECKING AND CHANGING PARAMETERS .............................................................................. 35
9.1. QUICK OPTIONS SCREEN: TOUCH SCREEN ..................................................................................... 35
9.2. LOGGING IN............................................................................................................................. 40
9.3. SYSTEM PARAMETERS ............................................................................................................... 40
9.4. MAINTENANCE ........................................................................................................................ 41
10. MAINTENANCE INSTRUCTIONS ............................................................................................... 42
10.1. PREVENTIVE AND SCHEDULED MAINTENANCE ................................................................................ 42
10.2. CLEANING THE WATER OUTLET STRAINER (GS-2A 5075 ONLY)........................................................ 42
10.3. REPLACING THE HEPA AIR FILTER (GS-2A 5075 ONLY) .................................................................. 43
11. TROUBLESHOOTING................................................................................................................ 44

Page 3
1. General
Read the Operating Instructions carefully, before beginning any operation on
the autoclave!
1.1. Incoming Inspection
Upon receiving your Tuttnauer Autoclave, carefully inspect the outside of the shipping
carton for signs of damage. If any damage to the carton is found, note the location
with respect to the autoclave and check that area of the autoclave carefully once it is
fully unpacked. 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 any damage is found, contact your dealer as soon as possible so that they
can file a claim with the shipping carrier and also notify Tuttnauer.
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.
Note: Lifting and carrying should always be done by two people.
1.2. Warranty Description
We certify that this instrument is guaranteed to be free from defects in material and
workmanship for two years against faulty components and assembly with the
exception of glassware, lamps and heaters.
This warranty does not include routine cleaning and preventive maintenance, to
be performed according to instructions in 10.1 (Preventive and Scheduled
Maintenance).
Tuttnauer warrantees all new GS-2A autoclaves for a period of one full year, covering
parts (except door gaskets and HEPA filters -- they are considered wear items).
Tuttnauer warrantees all chambers for a period of ten (10) years against defects in
materials and workmanship. This chamber warranty went into effect January 1997.
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
autoclaves that have been repaired or altered outside the factory without prior
authorization from Tuttnauer.
Tuttnauer’s obligation is limited to the repair or replacement of parts for the autoclave.
This warranty will be void if the unit is not purchased from an authorized Tuttnauer
dealer. No other warranties or obligations are expressed or implied.
The Autoclave should only be used in a manner 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 European Representative’s Technical Service Department can be reached at:
Tuttnauer Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda,
The Netherlands
Tel: [phone], Fax: [phone]
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 replacement parts are needed, stipulate the model and serial
number of the machine.
No autoclaves 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
of operation, the door safety mechanism; dangers involved in circumventing safety
means, how to ensure that the door is closed, and how to select a correct sterilization
program.
Never use the autoclave to sterilize corrosive products, such as: acids, bases and
phenols, volatile compounds or solutions such ethanol, methanol or chloroform nor
radioactive substances.
2.1. Safety features
The autoclave has the following features for hazard protection:
The pressure vessel chamber door has the following features protecting personnel
from hazards:
1. Two door switches that indicate that the door is closed and locked. Without this
indication steam is not introduced to the chamber.
2. A pressure switch that blocks door opening if the pressure is higher than 20% above
the ambient pressure.
These features are implemented in the following devices (limiters):
For the chamber:
a. Electrical door lock
b. Mechanical membrane door lock
c. Mechanical safety valve (1 for chamber and 1 for generator).
For the generator:
a. Cut-off pressure switch
b. Cut-off thermostat
The main power is shut off if there is lack of water or the pressure is above
the safe level.
Below are the safety instructions:
2.2. 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. 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.
3. On closing the device door, make sure it is properly locked before activating. Verify
that DOOR OPEN symbol is replaced by the load number.
4. When withdrawing trays, wear heat resistant gloves.
5. Before opening the door, verify that the pressure in the chamber equals the
atmospheric pressure (chamber pressure is displayed on the screen).
6. Unlock the door properly: see 8.3.
7. 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.and remove the load.
8. Once a month, ensure that the safety valve is operating, and once a year certified
inspector must perform pressure chamber safety test.
9. Once a year, or more frequently, effective tests must be performed, i.e., calibration
and validation.
10. Make sure there are no leaks, breaks, blockages, whistles or strange noises.
2

Page 5
11. Perform maintenance operations as instructed. The owner of the autoclave is
responsible to perform the maintenance operations.
12. Notify the person in charge immediately of any deviation from the proper function of
the device.
13. Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or rules!
14. This autoclave equipped with rear and front wheels, when moving the autoclave all
utilities must be disconnected, at least 2 persons shall move the autoclave with
caution. When the autoclave located in the required place, the wheels have to be
locked. For further information see FRONT/REAR VIEW of the autoclave.
2.3. Operating Conditions
1. This device is for indoor use only!
2. The sterilizer should be loaded only with autoclavable material!
3. Do not use the autoclave in the presence of dangerous gases.
4. Minimum room ventilation shall be 10 cycles per hour.
5. The environment shall not exceed an ambient temperature range of from 5ºC (41ºF)
to 40ºC (104ºF) and a relative humidity of 85% respectively.
6. The operational altitude shall not be over 2000 meters (6562 feet) (ambient pressure
shall not be lower than 80 kPa (11.6 psia)).
7. Operate the autoclave only in the manner specified in the manual. If the equipment is
used in a manner not specified by the manufacturer, the protection provided by the
equipment may be impaired.
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!
3. General Information
3.1. Introduction
The GS-2A autoclave is designed for sterilization of wrapped and unwrapped
instruments, and related items found in dental, medical, and veterinary clinics, first aid
rooms, hospitals laboratories etc.
This autoclave is a steam-heated sterilizer using steam as the sterilizing agent. A
computerized control unit ensures a fully automatic sterilization cycle, control and
monitoring of physical parameters and a clear documentation of the sterilization
cycle.
The autoclave offers a choice of automatic programs designed to match the material
to be sterilized. The autoclave is equipped with a vacuum pump (GS-2A models only)
that during the drying stage draws air through a HEPA filter (0.2µm) and pushes that
air through the heated chamber to remove moisture and facilitate the drying
operation. Drying is performed with the door closed.
This autoclave is equipped with a vacuum system. The advantages of the pre-
vacuum sterilizer in comparison to the regular gravity displacement steam sterilizer
are as follows:
Removal of air pockets from packs and porous load and most kinds of tubes (rubber,
plastic etc.) by vacuum at the first stage of the cycle.
Better steam penetration into the load; resulting in effective sterilization.
Better temperature uniformity.
The autoclave is equipped with two Automatic Hinged doors. The doors are closed
manually, and then locked by an automatic pneumatic mechanism. Similarly, at the
end of a cycle, the doors are un-locked, and can be opened manually.
The autoclave is mounted through a recessed wall. The two doors are located in two
separate rooms, completely isolated.
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Page 6
The front door, on the side of the master control panel is in the preparation area, from
where the autoclave is operated and serves for loading the material into the
sterilization chamber. This area is known as the "dirty side." The rear door is located
on the "clean side" and serves for unloading the sterilized material from the
autoclave. This side of autoclave is equipped with secondary control panel (slave).
The interlock system of the door is based on the following opening conditions:
The door cannot be opened while the autoclave is in operation.
The door cannot be opened if the chamber is under pressure.
The door cannot be opened if there is liquid in the chamber.
The door cannot be opened at the end of the cycle if the chamber temperature is
higher than the preset final temperature.
The sealing of the chamber is achieved through heat resistant silicone gaskets,
located in grooves around the doors openings of the autoclave .
An 18kW built-in steam generator supplies the steam for the sterilization process.
The GS-2A series features a digital display for monitoring and control purposes. The
device is capable of displaying the pressure in psia, psig, or in kPa according to the
operator’s requirements. When the pressure is displayed in psig, the atmospheric
pressure is shown (at sea level) as 0 psig. If the pressure is defined in psia or kPa the
absolute zero is displayed as “0” and the atmospheric pressure is shown (at sea level)
as 14.7 psia or 100 kPa respectively. The GS-2A can display temperature in ºF or ºC.
A printer is a standard addition to the autoclave. The printer prints the preset and
actual parameters of the cycle (temperature, time and pressure).
The GS-2A features built-in memory to record up to 100 sterilization cycles. These
can be reprinted on the printer or exported to a USB device to be transferred to a PC.
Caution!
Only technical personnel having proper qualifications and holding
technical documentation (including a technician manual) and adequate
information are authorized to service the apparatus.
3.1. Front Panel and Rear Panel
Front Panel Loading (“Dirty”) Side
The operation and controlling of the autoclave is performed through the Touch screen
Interface. The Service Access Door on the lower part of the front panel enables service
under the chamber.
Rear Panel Un-Loading (“Clean”) side
The operation and controlling of the autoclave is performed through the Touch screen
and Keypad.. The Service Access Door on the lower part of the Rear panel enables
service under the chamber.

Page 7
3.2. Specification
Property
5075
50125
Chamber
Diam.
49.4cm
49.4cm
Depth
75.0cm
125cm
Chamber volume
160 liters, usable
volume 144 liters
250 liters
Max. Allowable Working
pressure (MAWP)
2.8bar
Net weight
520kg
Shipping weight
Floor loading requirements
According to the Overall
weight and floor
requirements
According to the Overall
weight and floor
requirements
Max load
24 kg solid load or 12 kg
textile
30 kg solid load or 22 kg
textile
Tray dimensions
Big
(47.3 x 70 x 2 cm)
Small
(30.3 x 70 x 2 cm)
No. of trays
2
Load No. counter
Counting from 0 to 9999 and nullifies.
3.3. Generator's Steam Data
Property
18kW
Max. working pressure
3 BarG
Safety relief valve
5 Bar
3.4. Generator's Electrical Data
Property
Value
Voltage
3 ph, 400V
Frequency (Hz)
50/60 Hz, depending on your
country standard
Generator Consumption
27A (18kW)
Heaters
18kW
3.5. Autoclave's Electrical Data (the Generator is Not
Included)
Property
5075
50125
Voltage
1 ph, 230V
1 ph, 230V
Frequency (Hz)
50/60 Hz
50/60 Hz
Consumption (the generator is not
included)
6A
6A
Total power
400W
400W
Degree of protection by enclosure
IP31
IP31

Page 8
3.6. Utilities
Property
Value
Electric Power
Supply
Power Supply
3Ph, 400V,50/60Hz
depending on your
country standard
Recommended circuit breaker
32A (18kW)
Line current
30A(18kW)
Protection against electrical
shock
Class I (IEC 60601-1)
Mineral-free water inlet
1/2", 1-3 Barg
Tap water inlet
1/2", 2-5 Bar
Drain
3/4", withstanding temp. of
80°C
A switch or circuit-breaker must be included in the building installation. This switch or
circuit-breaker shall be in close proximity to the equipment, within easy reach of the
operator; and marked as the disconnecting device for the equipment.
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.
Verify that there is an easy access to the main power switch, to the water cut-off
valve and to the current leakage safety relay.
Make sure while placing the autoclave, to leave space around the machine, to give
the technician access to service the machine.
All water connections to autoclave must be performed through "BACK FLOW
PREVENTION SYSTEM" only, as per IEC 61770.
Cautions!
In order to avoid any injury by electrical hazard, it is recommended that a
ground fault protection device (GFCI) be installed in the electrical panel
feeding the autoclave (local codes may make this mandatory).
The electrical network must comply with local rules or regulations.
Verify that there is an easy access to the main power switch and to the current
leakage safety relay (GFCI). The voltage supplied to the device must comply
with the label ± 5%.
Note: The electrical network must comply with local rules or regulations. Verify that there is an
easy access to the main power switch and to the current leakage safety relay (GFCI).
The voltage supplied to the device must comply with the label ± 5%.
3.7. Environmental Emission Information
1. The peak sound level generated by the autoclave is 70dBa with background noise of
60dBa.
2. The total heat per hour transmitted by the autoclave is <300Wh.
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 304.
Pressure vessel is made of stainless steel 316L.
Cabinet is made of stainless steel 304
Trays are made of stainless steel 316L.
Generator's vessel is made of stainless steel 304/316L.
Door closing handle is made of aluminium material, which is safe to touch and
thermo-insulated.

Page 9
3.9. Stickers Description
Symbol
Meaning
Part Number
Location
Caution! Consult
accompanying
documents
LAB048-0024
Near the cut-off
Caution! Hot steam.
LAB048-0058
Near the safety valve
Caution! Hot surface.
Protective earth
(Ground)
LAB048-0020
Near the on/off switch
ON
OFF
On-Off
LAB048-0018
Near the Power switch
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 sterilizers (According to EN 13060: 2010)
Element
Condensate – allowable content
Silicon dioxide SiO2
≤0.1 mg/kg
Iron
≤0.1 mg/kg
Cadmium
≤0.005 mg/kg
Lead
≤ 0.05 mg/kg
All other metals except iron, cadmium, lead
≤0.1 mg/kg
Chloride (Cl)
≤0.1 mg/kg
Phosphate (P2O5)
≤0.1 mg/kg
Conductivity
≤3 μs/cm
pH value (degree of acidity)
5 to 7
Appearance
Colorless clean without sediment
Hardness (Σ Ions of alkaline earth)
≤0.02 mmol/l
Compliance with the above data should be tested in accordance with acknowledged
analytical methods, by an authorized laboratory.

Page 10
Attention: We recommend testing the water quality once a month. The use of
water for autoclaves that do not comply with the table above may have severe
impact on the working life of the sterilizer and can invalidate the manufacturer’s
guarantee.
Cautions!
Use Only deionized water, Having a maximum conductance of 1 microSiemen
per cm (1 μS/cm)
Tap Water supply
Maximum hardness value 0.7-2.0 mmol/l
The use of soft water is strictly forbidden! Please consult a water specialist!
Compliance with the above data should be tested in accordance with
acknowledged analytical methods, by an authorized laboratory.
3.11. Directives and Standards
Every autoclave meets the provisions of the following Directives and is in compliance
with the following Standards:
Tuttnauer. Ltd. company meets the provisions of the following standards:
ISO 13485:2003 (Quality Systems for Medical Devices)
ISO 9001:2008 (Quality Systems)
MDD 93/42/EEC (Medical Device Directive)
Tuttnauer. Ltd. company also works in conjunction with and refers to:
ANSI/AAMI ST55 American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels.
EN 13060 Small Steam Sterilizers.
UL UL 61010-1
PED 97/23EEC
IEC IEC 61010-2-040 Safety
ISO 17665-1:2006 (Validation and Routine Control)

Page 11
3.12. Overall Dimensions 5075GS-2A

Page 12
3.13. Overall Dimensions 50125GS-2A

Page 13
3.14. Rear Panel Un-Loading (“Clean”) Side View -- 5075GS-2A
No.
Description
No.
Description
1
Touch screen
4
On/off switch
2
Chamber Door
5
Service door
3
Wheel
3
4
2
1
5

Page 14
3.15. Front Panel Loading (“Dirty”) Side View – 5075GS-2A
No.
Description
No.
Description
1
Printer
11
Network cable
2
Touch screen
12
Chamber and generator safety valve s
3
Chamber pressure gauge
13
Fast exhaust strainer
4
Generator pressure gauge
14
Power cable socket
5
Chamber door
15
Tap water inlet for drain cooling
6
Tap water reservoir. Left
opening - overflow, leave open.
Right opening – inlet, to be
connected.
16
Service door
7
Tap water drain
17
Mineral-free water reservoir. Left opening -
overflow, leave open. Right opening – inlet,
to be connected.
8
Wheels
18
Chamber drain
9
Fan
19
Mineral-free water drain
10
Air filter opening
3
8
11
13
7
4
2
1
5
6
10
9
14
16
15
17
18
19
12

Page 15
3.16. Rear Panel Un-Loading (“Clean”) Side View -- 50125GS-2A
No.
Description
No.
Description
1
Touch screen
4
On/off switch
2
Chamber Door
5
Service door
3
Wheel
3
4
2
1
5

Page 16
3.17. Front Panel Loading (“Dirty”) Side View – 50125GS-2A
No.
Description
No.
Description
1
Printer
11
Chamber and generator safety valve s
2
Touch screen
12
Power cable socket
3
Chamber pressure gauge
13
Service door
4
Generator pressure gauge
14
Mineral-free water inlet, to be connected
5
Chamber door
15
Mineral-free water overflow, leave open
6
Tap water inlet, to be connected
16
Drain
7
Tap water overflow, leave open
17
Drain
8
Wheels
18
Chamber drain
9
Fan
19
Mineral-free water drain
10
Network cable
3
8
10
12
7
4
2
1
5
6
9
13
15
14
16
18
19
11
17