Service Manual Aut-Castle-Getinge (Col)

TR-SM-B-EN rev08 Service Manual for 4.
4 Series Page: 1 of 124
Castle / Trans Smart Steam Sterilizer

Service and Maintenance Manual
DOC ID: TR-SM-B-EN rev08
Effective Date: 05.06.2020
Print-outs and copies of this document have to be checked for validity and correctness before use.
TR-SM-B-EN rev08 Service Manual for 4.4 Series Page: 2 of 124
TABLE OF CONTENTS
Index of warnings ............................................................................................................... 4
1. Preface ....................................................................................................................... 7
1.1. Contact Information .................................................................................... 12
1.2. Machine Identification .................................................................................. 13
2. Safety........................................................................................................................ 16
2.1. Product Liability ......................................................................................... 16
2.2. Safety Precautions .................................................................................... 16
2.3. Safety Features .................................................................................... 19
2.3.1. Safety Interlocks ................................................................................... 21
2.4 Mandatory Reporting .................................................................................. 23
3. Description............................................................................................................... 24
3.1. PI Diagram Legend .................................................................................. 24
3.2. Generic Components .................................................................................. 26
3.2.1. Strainers ............................................................................................ 26
3.2.2. Piston Valves ....................................................................................... 27
3.2.3. Steam Trap ......................................................................................... 28
3.2.4. Safety Valves ........................................................................................ 29
3.2.5. Pressure Gauges .................................................................................. 30
3.3. Doors ........................................................................................................... 31
3.3.1. Door Opening .................................................................................... 31
3.3.2. Door Gasket ....................................................................................... 32
3.4. Water Supply .................................................................................... 36
3.5. Steam Equipment ............................................................................. 40
3.5.1. Steam Generator ............................................................................... 40
3.5.2. Feed Water ....................................................................................... 45
3.5.3. Blowdown Equipment .......................................................................... 46
3.5.4. Blowdown Steps ............................................................................... 47
3.5.5. Pressure Transmitter .......................................................................... 48
3.5.6. Pressure Switch .................................................................................. 49
3.5.7. Steam Piping .................................................................................... 50
3.6. Chamber and Jacket .................................................................................. 52
3.6.1. Chamber Ports ............................................................................... 52
3.6.2. Drain ................................................................................................. 53
3.6.3. Jacket ............................................................................................... 54
3.7. Vacuum Unit ............................................................................................ 56
3.8. Air Filter ................................................................................................. 59
3.9. Electrical Power Cabinet ........................................................................ 60

3.10. Control System Hardware ........................................................................ 61
3.10.1. Controller ............................................................................................ 61
3.10.2. HMI Interface ............................................................................... 62
4. Screen Software ...................................................................................................... 64
4.1. User Groups and Access Rights ................................................................. 64
4.2. Menu ............................................................................................... 67
4.2.1. The Service Menu................................................................................. 78

5. Preventative Maintenance ...................................................................................... 91
5.1. Pre-requisites and Maintenance Actions Overview .................................. 91
5.1.1. PM Actions when Media and Power is Turned Off ............................... 91
5.1.2. PM Actions in Standby mode ............................................................... 96
5.1.3. PM Actions when Restarted ................................................................. 97
6. Alarms and Messages ............................................................................................ 99
6.1. General ...................................................................................................... 99
6.2. System Alarms and Messages .................................................................. 100
6.3. Daily ....................................................................................................... 106
6.4. Weekly .................................................................................................... 108
7. Shutdown ............................................................................................................... 109
8. Program Combination .......................................................................................... 112
8.1.1. Steam Sterilization ........................................................................ 113
8.2. Parameter Information ...................................................................... 114
8.3. Programs ..................................................................................... 114
Index of warnings
WARNING
RISK OF INJURY
Working behind the panels of the sterilizer is allowed for trained
service technicians only. It involves the risk of injury by crushing,
pinching, cutting, burns and high pressure, combined with the
risk of hearing impairment and contact with live electrical
equipment. To avoid injury, always use appropriate personal
protective equipment, and follow the instructions in the manual.
WARNING
RISK OF INJURY
Use Trans Medikal A.Ş approved accessories only.
WARNING
RISK OF INJURY
A reading on the pressure gauge which is greater than 3,8 bar
indicates a dangerous pressure.
If the reading on the pressure gauge is greater than 3,8 bar,
leave the area immediately and contact a local service
technician.
WARNING
EXPLOSION HAZARD
Processing of liquids may cause explosions or burns except
choosing of open liquid program (Optional).
WARNING
RISK OF INFECTION
Do not process biohazardous waste in the sterilizer.
WARNING
RISK OF INFECTION
The load must be cleaned before it is sterilized.
Unclean load will lead to non sterile load and risk of infection.
WARNING
RISK OF INJURY
Water leakage may cause a conductive path from live electrical

parts.
WARNING
FIRE HAZARD
Goods containing fabrics or other porous material must not be
left in the sterilizer chamber previous to or after sterilization.
Such goods may ignite due to heat and excessive drying.
WARNING
RESTERILIZATION PRECAUTIONS
Before starting a new sterilization after an incomplete one, make
sure that the goods and the packaging material are intended for
repeated sterilizations. If necessary, prepare or repackage the
goods before restarting the sterilization.
Consult the hygiene manager or the manufacturer of the goods
and packaging material for instructions.
WARNING
BURN HAZARD
The door and the chamber can be hot and may cause burns. Be
aware of hot surfaces inside the chamber when the door is open.
WARNING
BURN HAZARD
The goods may be very hot immediately after unloading. Allow
the goods to cool down or wear safety gloves when handling the
goods.
WARNING
RISK OF INJURY
During a running program, do not switch off the power to the
sterilizer unless it is absolutely necessary due to an emergency
since this affects the safety system of the sterilizer.
WARNING
RISK OF LEAKAGE
During a power outage, or if the power to the sterilizer has been
turned off during a process, there is a risk of leakage.
If there is positive pressure in the chamber, keep away from the
door and contact a local service technician.
WARNING
HOT SURFACE
The sterilizer must cool down before cleaning. Before cleaning,
turn off the sterilizer and allow to cool, for example overnight.
WARNING
RISK OF CROSS CONTAMINATION
Do not process hazardous waste in this sterilizer.
WARNING
HEAVY PARTS
When dismounting the sterilizer's doors or chamber, make sure they
are properly supported to avoid crushing accidents.
1. Preface
Before using the sterilizer, read all instructions and become familiar with
the design, safety features and operation of the unit.
Trans Medikal A.Ş shall not be liable for any damages, directly or
indirectly, due to actions, which are not in accordance with this manual.
Daily user serviceable parts and procedures are described in the User
Manual.
Maintenance and repair of the sterilizer are to be performed by trained

maintenance personnel and service technicians only. To protect the
daily user from hazardous conditions, there are no daily user
serviceable parts behind the panels nor in the service area.
WARNING
RISK OF INJURY
Working behind the panels of the sterilizer is allowed for trained service
technicians only. It involves the risk of injury by crushing, pinching,
cutting, burns and high pressure, combined with the risk of hearing
impairment and contact with live electrical equipment. To avoid injury,
always use appropriate personal protective equipment, and follow the
instructions in the manual.
Intended Use
Trans Steam Sterilizers are designed to sterilize “Medical Items” suitable

for high-pressure steam sterilization.
The sterilization process is applicable for pore or non-porous, heat and

moisture resistant medical items declared by the manufacturer for re-
use, such as surgical instruments, textiles, paper, plastic, hospital
instruments suitable for steam sterilization between 121 °C and 134 °C.
Trans Steam Sterilizers are designed for use in hospital buildings such
as central sterilization departments, surgical departments and
emergency rooms, as well as health care clinics, sterilization sub-
contractor facilities, laboratories, laundries and dental clinics.
This device is intended for professional use and should only be used by
persons trained by Getinge Technical Service. The device must be used
for the sterilization of medical materials in accordance with its intended
use.
Related Publications
The following user documentation is supplied with the sterilizer:

• User Manual
• Installation Manual
• Service Manual
• Product Specification
NOTE
For updated spare part, list please contact with Aftersales Team
The symbols indicate a warning, an attention or a note.
Symbols in this Manual

To emphasize the importance of warnings, instructions and advice in
this manual, the following categories are used to draw attention to them.
Warning burn hazard, hot

surface.
The equipment, parts of the

equipment or the presence of
an agent (such as steam) are
hot enough to cause burns.
Warning pinch hazard.
The equipment or parts of the

equipment could pinch or crush
a part of the user's body.
Warning shock hazard.

Exposed parts of the
equipment are at a
dangerously high electric
potential.
Warning risk of non-sterile

items.
Actions that could compromise
the effectiveness of the
equipment, or the on
sequences of not letting the
equipment complete its cycle.
Warning, risk of injury.
Warning explosion hazard.
Warning chemical hazard.

Warning fire hazard.
Symbols on the Sterilizer
The following symbols on the sterilizer informs users of possible

hazards.
Warning about unauthorized

staff.
Earth line.
Before start up sterilizer do not

forget to plug pipes
connections, pressure
transmitters and pressure
switches!
Company address.
Please evacuate antifreeze

from the vacuum pump and the
water pump before operate the
autoclave.
Do not try to operate doors

without removing fixed
connections from the counter
weights
Before loading the trolley on

the transport vehicle make sure
your mechanism is locked.
Please approach carefully.

Attention.
Situations that may cause
damage to equipment, load or
loss of data.
The note symbol alerts the

user to important facts and
conditions. It can also give
recommendations on the
usage of the unit.
Unauthorised person shall not

operate this machine.
Made in Turkey.
Medical device directive.

1.1. Contact Information
Trans Medikal Service

If additional help is required, contact an authorized Trans Medikal A.Ş
service representative:
www.transmedikal.com
Manufacturer Address
TRANS Medikal Aletler San. Ve Tic. A.Ş.
Ahi Evran OSB Mah. Kırımhanlığı Cad. No: 6A / 1
Sincan ANKARA/TURKEY
Phone: +90 312 387 3940
“Fax: +90 312 387 3948
1.2. Machine Identification
The Sterilizer Data Plate The identification information for the sterilizer is found on the sterilizer
data plate, attached to the machine. There are also jacket, chamber
and steam generator labels on the sterilizers, too.
When contacting Trans Medikal A.Ş concerning the sterilizer,
information included in the data plate is required.
Figure 1: Product label
1. Design Code
2. Serial Number
3. Produced Year
4. Product Name
5. Equipment Output Power
6. Brand/Model
7. Voltage (V)
8. Current (A)
9. Frequency
10. Type
11. Protective Class
12. IP Class
Figure 2: Vessel and Jacket Pressure Label
1. Design Code
2. Serial Number
3. Produced Year
4. Brand / Model
5. Volume
6. Test Pressure
7. Pressure Test Date
8. Design Pressure (Pd)
9. Design Temperature (Td)
10. Maximum Allowable Pressure (Ps)
11. Minimum Allowable Temperature (TSmin)
12. Maximum Allowable Temperature (TSmax)
13. Safety Valve Setting Pressure
14. Tare Mass
Figure 3: Generator Pressure Label
1. Design Code
2. Serial No
3. Produced Year
4. Model
5. Volume
6. Test Pressure
7. Pressure Test Date
8. Design Pressure (Pd)
9. Design Temperature (Td)
10. Maximum Allowable Pressure (Ps)
11. Minimum Allowable Temperature (TSmin)
12. Maximum Allowable Temperature (TSmax)
13. Safety Valve Setting Pressure
14. Tare Mass
2. Safety
2.1. Product Liability
Modifications to the equipment without the explicit approval of Trans

Medikal A.Ş, or incorrect use of the unit, will invalidate the
manufacturer’s product liability.
2.2. Safety Precautions
Read the Manual
The sterilizer is designed with a number of built-in safety devices. To

avoid injury, it is very important that these safety devices are not
disabled.
Read all instructions in this manual before operating the sterilizer.
Operator
The operator should have well understood the functions and meanings
of all controls of the device before using it.
The operator should have well understood and be able to implement

the safety precautions during operation of the device.
The operator should well understand all warnings contained in this User
Manual relating to device and its use.
The operators should not take any action on the device with their own
initiative and any action for which they are not assigned.
Electrical Safety
The front panel, side panels and service doors enclose spaces
restricted due to electrical safety and shall be opened by trained
services representatives only.
Before taking into use, the sterilizer and its installation must be
inspected and approved by an authorized electrician according to the
installation instructions and local codes.
This equipment or system has Class I protection, it must be connected

to power supply network which must have a Protection Earth to
eliminate electric shock.
Make sure that the device is connected to correct voltage.
Make sure that the device is properly grounded to the standards in force
in the country where it is to be installed.
Hot Surfaces
The sterilizer uses steam which cause hot surfaces at chamber and
sterilized goods. Wear gloves and personal protective equipment to
avoid burns or serious injuries at loading, unloading and cleaning.
NOTE
The sterilizer should have cooled down before cleaning. When the key
switch cannot be constantly observed, the person doing the cleaning
must always take the key with them. This is to ensure that no one
mistakenly resets the key switch.
Restricted Access
Always keep the door to the service area locked to prevent access of
unauthorized personnel.
Operation of the sterilizer is prohibited while paneling is opened or as

service personnel are inside in the service area.
When cleaning the machine, turn off the device, remove the on-off key
and keep it with you.
Other Considerations
Malfunctions and leaks (for example, a worn door gasket) shall be

checked or repaired by a service representative without delay.
Keep the sterilizer clean to ensure optimum performance.
Do not hose down the outside of the sterilizer with water.
Authorized persons are responsible for training the operators.
The operator is obliged to promptly inform the authorized persons of

any extraordinary and dangerous situations that may occur on the
device.
It is prohibited to remove or disable the safety devices.
Never dismantle or disassemble the sterilizer.
High voltage points within the device are dangerous.
Shut off the Mains power, if it is impossible to disconnect the device

from power supply. If the Mains power supply is not visible by the
person who will carry out repair operations on the device, or it is located
distantly, take the Mains power to “OFF” position and then affix a sign
plate “WORK IN PROGRESS” on it.
Keep the area around the sterilizer clean and dry.
Do not use any solution in labeling on the sterilizer.
Do not remove the labeling on the sterilizer. Request new one, if

required.
Wipe the device with a lightly wet cloth after making sure that the device
is in “OFF” position. Remove any moisture on the device before

proceeding with operation.
Do not pour water or any other liquid on the device. It may cause short
circuits or rusting of the device.
Do not contact the device with wet hands. Follow the safety precautions
for use of electrical appliances if your hands are wet.
The device is not designed to operate in environments where any gas

or explosive steams exist.
Any explosions or strong vibrations that do not expose the device to

mechanical effects.
Do not stand in front of the door while opening it. The steam that will
escape when the door is opened may cause injury.
Empty the water contained in the device, when handling it from one
location to another.
NOTE
It is strictly prohibited to modify, remove or change the settings of the
safety equipment by any way.
TRANS MEDİKAL ALETLER SAN. VE TİC. A.Ş. does not assume

responsibility for any damage to the persons or failure of the device
resulting from non-compliance with foregoing provision.
NOTE
Check the safety equipment periodically.
2.3. Safety Features
Safety Components
WARNING
The sterilizer includes components intended to ensure personal safety.
For this reason, they must not be replaced with components of any
make or design that has not been approved by Trans Medikal A.Ş. It is
of the highest importance that the reliability of these components is
maintained during the entire product life cycle. The signs are used to
indicate important components, as well as to draw attention to other
safety factors, such as dimensions, tolerances and materials.
Sound Power Level

Autoclave average sound level is 74,5 db.
Emergency Stop
Figure 4: Emergency Stop Button
The emergency stop button is a safety feature that will prevent

hazardous situations, both while running a program and in standby
mode. A push button for emergency stop button is located near the
door.
A push button for emergency stop button is located near the door.
When pressing the push button:
 An alarm is triggered.
 Any door motion stops immediately during a door operation.
 The current process is aborted.
 All valves for media to the chamber are closed.
For security reasons, it is not possible to lock the emergency stop
button when inactivated.
Once the emergency stop button has been pressed, it is locked. It is

not possible to restart or cancel a program while the emergency stop
is activated. Please call a service technician or other authorized
personnel that can unlock the emergency stop button.
NOTE
The emergency stop button cuts the outputs of controller except bypass
valve.
Protective Plates
Sheet metal surfaces that the user might touch are insulated and cooled
to a temperature that is safe to touch. However, the inside of the
chamber and the load might still be hot when the sterilizer is opened.
Front panels and cladding plates must not be opened by users. Service
technicians are authorized to work behind the panels.
The entire surface of the top edge of the door is covered by a steel plate.
Door Crush Protection It stops when pressure is applied from above. If the force is continued
to apply, then the door moves downwards.
The sterilizer chamber, jacket and the steam generator are pressure
Pressure Vessels vessels, designed and built in according to regulations and codes at the
country of installation.
Electrically - and pneumatically - controlled valves are spring loaded. If

Valves
the control medium fails, the valves return to a safe position, preventing
the flow of steam and water.
Safety Valves Providing the last line of protection, safety valves prevent the pressure
of the steam supply from exceeding the designed limits of the vessel.
The safety valves shall be inspected at prescribed intervals.
2.3.1. Safety Interlocks
Media to Chamber Interlock

The media to chamber interlock prevents media supply to the chamber
until the door is closed and the pressure behind the door gasket is high
enough to guarantee the tightness of the chamber.
The interlock is provided by software and hardware functions
Door Opening Interlock

If the pressure in the chamber is above or below atmospheric pressure,
the door cannot be opened.
Staff Requirements
The authorized operators and the service personnel should safety have
the following qualifications:
1. General knowledge to understand the contents of user manual;

2. Sufficient information on Sterilizer and its installation;
3. Health Care knowledge, Accident Prevention knowledge and
Knowledge on Technical Progress;
The persons to use and service the device are specified below:
Operator: The person who uses the device in accordance with its
intended use.
Authorized Person: The person or group of persons, who will train the
operator on operation, technical service and routine maintenance of the
device.
The authorized person is the person who is responsible for installation,
operation and use of the device.
Usage and Storage of User Manual
Purpose: This manual is an integral part of the device, and it is

recommended to make this manual available near the device for quick
and easy access.
You can access the following information in this manual.
Safe and effective use of the device;

The device should only be used as described in the User Manual. It
should not be used for purposes other than its intended use.
Occupational Health and Safety regulations should be known and
complied with at the site where the device is installed. The User Manual
should be stored at such a safe place that the personnel can easily
access. It should be used carefully. It should be avoided from being

damaged by any way. It is strictly prohibited to delete, revise or modify
the contents of the User Manual.
NOTE
Any drawings or documents accompanying the device should not be
provided to third persons. The copyright on all such documents belong
to TRANS MEDİKAL ALETLER SAN. VE TİC.A.Ş.
NOTE
It is strictly prohibited to photocopy this User Manual or as a whole.
NOTE
TRANS MEDİKAL ALETLER SAN. VE TİC. A.Ş. reserve its right to
revise or develop the information contained in this User Manual.
NOTE
In case the device is sold through an intermediary, this User Manual
should be supplied with the device. In such a case, the manufacturer
should be informed of the new purchaser.
2.4 Mandatory Reporting
The sterilizer is a medical engineering product that conforms to the EU

medical devices directive or is constructed in a manner similar to a
medical device, which requires the manufacturer to investigate
incidents and accidents involving the sterilizer. The medical devices
directive, states that the manufacturer must investigate the causes of
accidents and incidents and report them to the authorities concerned.
The investigation may lead to changes to the device or to the

instructions and guidelines for the manufacturer.
Incidents and accidents involving the Trans Medikal A.Ş sterilizer must
be reported immediately in writing.
Report the following circumstances:

• causing serious deterioration in the health of a person
• those which might cause serious deterioration in the health of a
person
• causing the death of a person
• those which might cause the death of a person.
Writing the report
1. Describe the accident or incident and its cause, including when

and where it occurred.
2. Describe the consequences of the accident or incident.
3. Write down the Serial Number of the sterilizer. The number is
found at the Sterilizer Data plate on the electrical cabinet.
4. Include contact information:
• Name
• Telephone number
• Address
• Email
5. Send the written report by letter, fax or email to:

TRANS Medikal Aletler San. Ve Tic. A.Ş.
Ahi Evran OSB Mah. Kırımhanlığı Cad. No: 6A / 1
Sincan, ANKARA/TURKEY
Tel: +90 312 387 3940
Fax: +90 312 387 3948
[email protected]
3. Description
This chapter contains a functional description of the sterilizer, to

facilitate reading the PI and wiring diagrams. The designations of
components in this chapter corresponds to the designations in the
diagrams. For detailed information about the sterilizer's parts and
construction, see the PI and wiring diagrams.
3.1. PI Diagram Legend
The following symbols are used in the piping and instrumentation

(PI) diagram:
3.2. Generic Components
3.2.1. Strainers
Strainers prevent deposits and particles in water and steam from

entering critical areas and causing malfunctions, leakage or reduced
performance.
Figure 5: Strainer
1. Strainer body
2. Strainer screen
3. Cap
For information about procedures and intervals for cleaning the

strainers, see preventive maintenance check list.
3.2.2. Piston Valves
Piston valves are used for various media as shut-off valves or as control
valves with an on/off function. The valves can be normally closed (N.C.)
or normally open (N.O.) and when the actuator is activated the valve
alters its mode.
Figure 6: Piston Valve

1. Transparent cap
2. Pilot air ports
3. Actuator
4. Piston seal
5. Spring
6. Tube
7. V-Seals
8. Wiper
9. Nipple
10. Spindle
11. Pin
12. Swivel plate
13. Seal
14. Valve body
The seals in the valve are exposed to wear and can be restored by a
restoration kit. Valves controlling steam are the most exposed and shall
be restored according to the maintenance plan.
Wear and tear in the valve actuator will give rise to leakage of
compressed air to the surroundings. Leakage into the valve body and its
media is prevented by a vent hole in the stainless steel guide tube.
Wear and tear of the stainless steel pipe sleeve couplings can give rise
to leakage between the part of the valve body that is connected to the
top of the valve stem and the vent hole in the stainless steel pipe
sleeve.
Depending on how the valve is connected, leakage can be detected by
performing a leak test or by visible leakage of media through the hole.
Damage to, or dirt on, the valve body stem seal can cause leakage
between the inlet and outlet sides of the valve. If the valve is connected
to the sterilizer chamber, the easiest way to detect leakage is by
performing a leak test.
Leaking gaskets, spindle directed to media or poorly tightened actuator
nut can cause an outwards leakage of media when the valve is closed,
and inwards leakage of air when the valve is open. This leakage is
caused by ejector effect and can damage the sterilization process if air
is present.
3.2.3. Steam Trap
Steam traps stops steam from running through the piping but lets water
and cool air pass through.
Figure 7: Steam Trap
Steam traps operate on the basis of the Bernoulli principle which

depends on the relationship between the velocity and the pressure
applied by the condensate and the steam inside the steam trap. They
have only a moving part – the disc.
The traps may operate up to a back pressure of 80% of the inlet
pressure, but for smooth operation it is recommended that the back
pressure does not exceed 50% of the inlet pressure. Steam traps
discharge the condensate intermittently.
3.2.4. Safety Valves
The sterilizer has monotype safety relief valve.

Possible safety relief valve locations are at the:
- Steam generator
- Jacket
- Chamber
Figure 8: Safety Relief Valve

1. Steam Inlet
2. Steam Outlet
3. Seal
WARNING
RISK OF INJURY
During the control tests of the safety valves, the technician should
be careful about the hot steam to be released.
Seal for Pressure Adjustment
The safety relief valve's pressure adjustment is set by the manufacturer

and then sealed. If the seal has been broken, replace the valve as its
opening pressure might have been changed.
3.2.5. Pressure Gauges
The pressure gauges on the sterilizer have a marked accuracy

acceptance range that the gauge shall be within in atmosphere
pressure.
Figure 9: Pressure Gauge

1. Accuracy acceptance mark.
3.3. Doors
This chapter describes the functions of the door and the door gasket
that seals between the door and chamber during process
3.3.1. Door Opening
Figure 10: Door Control Diagram
1. Circuit breaker
2. Thermic relay
3. Opening contactor
4. Closeting contactor
5. Door motor
3.3.2. Door Gasket
Door Gasket Control
Figure 11: Air Regulator, Gasket and Channel Inlet Port View
1. Door gasket
2. Air regulater of gasket
3. Gasket channel inlet port
NOTE
During the replacement of the door gasket, use grease.
6032280338 GREASE-DOOR GASKET OIL
Figure 12: Gasket Pressurization Setup
1. Air pump
2. Air conditioner & Air pressure transmitter
3. Pilot valves
4. Air regulator
5. Gasket channel inlet port
Door Gasket Control During Process
When the sterilization process starts, the gasket inflation valve (SV105-
5) is opened. System checks the signal and if the valve does not open
within 10 seconds, ‘gasket inflation error’ warning is received. If the
gasket pressure decreases during the operation, gasket pouring switch
interrupts the signal and gasket inflation valve is came into play. If this
signal does not comes within 5 seconds, ‘low gasket pressure’ error is
received. If this occurs 5 times consecutively during the operation,
‘gasket air leakage’ error is received.
Figure 13: Gasket Pressurized Line View
When gasket pressurized the air follow above steps, first controller
opens pilot valve of door gasket, then air pass through air regulator and
front door gasket channel. Back door gasket channel pressurized by
front door gasket channel air outlet port. Back door uses same port for
pressurization and vacuum activities.
Figure 14: Gasket Pull Back Piping

1. Front door gasket channel outlet port
2. Back door gasket chanenel inlet /outlert port
3. Gasket vacuum solenoid valve
4. Vacuum pump inlet port
3.4. Water Supply
General Information
Under normal conditions, the sterilizer is designed for incoming
cooling water within the temperature range 4-35°C, and with a
pressure range of 4-6 bar.
Figure 15: Feed Water Supply

1. Water inlet port
2. Water outlet port via strainer
Circulation Tank
The circulation tank is a water reservoir for cooling and sealant (service)
water.
Figure 16: Circulation Tank

1. Circulated water inlet (vacuum pump return)
2. Circulation tank drain valve
3. Service water inlet / mechanical level float valve
4. Electronic level sensor
5. PT100 temperature sensor
When the water level drops, mechanical float valve opens and refills
water to the maximum water level. The maximum water level can be
adjusted by loosening the screws to the mechanical float valve and
move it up and down.
If the water level drops too low, the electronic level sensor switches
contacts and an alarm triggers.
www.getinge.com
Feed Water Tank
Figure 17: Feed Water Tank

1. Water inlet mechanic float valve
2. Water level switch
3. Water outlet strainer
4. Tank Drain
In the connection to the float valve, there is a plastic strainer to

prevent particles from entering the valve.
When the water level in the feed water tank drops, the mechanical float
valve opens and refills water to the maximum water level. The
maximum water level can be adjusted by moving the floater on the
arm.
If the water level drops too low, the electronic level sensor switches
contacts and an alarm triggers.
The quality of feed water can affect the quality of steam supplied to the
sterilizer, please see the table below. (Ref: EN 285 Annex B)
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Feed Water Quality
Contaminants in feed water supplied a dedicated steam generator.

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3.5. Steam Equipment
3.5.1. Steam Generator
The steam generator has a volume of different liters according to

chamber volume. It is controlled by the sterilizer's control system,
which keeps the operating pressure and water level within pre-set
limits.
Figure 18: Steam Generator

1. Safety valve
2. Pressure transmitter and manometer connections
3. Steam outlet port
4. Electronic float switch
5. PT100 temperature sensor
6. Liquid level probe
7. Heaters
8. Filling and drain port
Parent ID
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Steam Generator Limits
Pressure Limit Action
3.7 bar (abs) The heating elements are

activated
3.8 bar (abs) All heater elements are

deactivated
4.1 bar (abs) Generator high pressure error

limit (error code )
4.3 bar (abs) Safety switch activation limit.

All heater elements are
deactivated by mechanically
4.5 bar (abs) Safety valve opens
When steam generator is empty, it will take more than four minutes to
fill it. To prevent alarms during startup, the steam generator can be
prefilled manually from the control panel.
Liquid Level Probe The switch starts the feed water pump when the water level in the
steam generator sinks below the switch. The pump runs until the
switch is activated and for another 15 seconds. Filling for more than 4
minutes will result in a Steam generator fill time alarm to prevent
boiler overfilling or flooding.
Figure 19: Normal Level Switch.

1. Liquid level port
2. Liquid level probe
3. Probe cable connection
Parent ID
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The liquid level relay measures conductivity between earth and liquid
level sensor, if generator doesn’t have water, the relay changes
contacts position and send signal to controller.
Figure 20: Electronic Float Switch

1. Low level switch
2. Up level switch
3. Float
Figure 21: Electronic Float Switch Levels

1. Up level
2. Middle level
3. Low level
Parent ID
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Water Level Limit Action

(Approximate values)
Up level : Up level of float switch controls
water pump, if up level switch is
not active (NC contact has been
used) , it doesn’t send signal to
controller than water pump
starts to fill generator until up
level switch connect signal the
signal.
Middle level: If up level switch is not
activated during 2 min, an
alarm triggers
Low Level: Low level of float switch controls

heaters, İf low level switch is
active (NO contact has been
used), it sends signal to controller
than controller cuts the power of
heaters.
The heating coils are turned off.
If the water level remains below
the Low level for 50 seconds the
Steam generator water level
The low level switch prevents the generator from boiling of without
alarm is triggered
water when the water level is below the top of the heating elements.
When the water level below the switch's limit, the heating elements
are turned off.
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Heating Elements
The steam generator can have different number and sized of

heaters according to volume of chamber.
Figure 22: Heating Element

1. Generator heater connection port
2. Heater flange
3. Electric connections
4. Cover
The generator has single one phase heating elements, 3 phases

distributed on the heaters. Heaters are controlled by 3 phase
contactors. Heating elements neutral connection pass though on
steam generator pressure switch. If pressure of generator greater
than specified limit, pressure switch disconnects the neutral
connection.
Parent ID
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3.5.2. Feed Water

The feed water pump supplies the steam generator with water. It is
a self-priming centrifugal pump powered by a single phase electric
motor.
Figure 23: Feed Water Pump and Connections

1. Water inlet mechanic float valve
2. Water outlet strainer
3. Tank drain
4. Water outlet
5. Water inlet
6. Water pump solenoid valve
7. Check valve
8. Generator water inlet / outlet
Parent ID
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3.5.3. Blowdown Equipment
During a blowdown, the manual valve to the drain at the bottom of the
steam generator should open half to be controlled .The steam
pressure then pushes the bottom water out together with impurities
on the bottom of the generator.
In a steam generator the content of chlorides, carbonates and other
impurities accumulates in the water as steam is produced. With high
levels of impurities in the water, the produced steam may contain non-
condensable gases which affects the sterilizer's performance and
service life. As the level of impurities is highest in the bottom water,
periodic blowdowns reduce the non-condensable gases in the steam.
Figure 24: Blow Down Equipment

1. Generator water inlet / outlet
2. Blow down manual valve
3. Drain connection
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3.5.4. Blowdown Steps
1. With drain cooling system;
a. Open the device

b. Wait for the heating (approximately 10-15 min)
c. Open 50% of the generator valve
d. Wait 5 minutes for emptying the generator
e. Activate the drain cooling valve
(menu service water saving  drain cooling)
f. Close the generator valve
g. Disable the activation of drain cooling valve
h. Below errors can be occur;
I. 107- Water level sensor fail.

II. 108- Water pump time – out.
III. 109- Generator Low water level (LLR)
IV. 113- Generator water level is low.
V. Water pump time-out error will occur. If you see this error more
than 5 times, please contact with your local technical service
2. Without drain cooling system;
a. Open the device

b. Wait for the heating (approximately 10-15 min)
c. Close the device after generator pressure reaches 3.7 bar
d. Open 50% of the generator valve
e. Wait 5 minutes for emptying the generator
f. Close the generator valve
g. Below errors can be occur;
I. Water pump time-out error will occur. If you see this error more
than 5 times, please contact with your local technical service
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3.5.5. Pressure Transmitter
Figure 25: Pressure Transmitter

1. Chamber pressure transmitter
2. Chamber supervisor pressure transmitter
3. Jacket pressure transmitter
4. Generator transmitter
The pressure transmitter located top of the sterilizer, used transmitter

measurement range is 0-6 Barr. High temperature can effect to
transmitters therefore, transmitter has been prevented by Teflon
isolator.
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3.5.6. Pressure Switch
Figure 26: Pressure Switch

1. Gasket pressure switch
2. Door safety pressure switch
3. Chamber safety pressure switch
4. Jacket safety pressure switch
5. Generator safety pressure switch
The pressure switches used in order to keep pressure within certain

levels. When pressure raised up to set point of pressure switch, the
switch changes contacts position.
Pressure Switch Pressure Limit

Gasket pressure switch (B204) 2.0 bar (g)
Door safety pressure switch (B207) 0.2 bar (g)
2.5 bar (g)

Chamber safety pressure switch (B202)
2.7 bar (g)

Jacket safety pressure switch (B203)
3.3 bar (g)

Generator safety pressure switch (B208)
Jacket safety pressure

switch
3.7
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3.5.7. Steam Piping
Steam Piping Bottom
Figure 27: Steam Piping, Bottom of Sterilizer

1. Steam from steam generator
2. Strainer
3. Steam separator
4. Steam separator condensate outlet
5. Steam pipe connection between bottom and top
Steam separator used in order to separate dry steam and wet steam,
wet steam goes to drain via steam trap.
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Steam Piping Top
The piping of steam supplies to the chamber and the jacket
Figure 28: Steam Piping on the Top of the Sterilizer

1. Steam / Air to chamber connection
2. Steam to jacket connection
3. Steam to jacket valve
4. Steam to chamber valve
5. Steam pipe connection between bottom and top of chamber
6. Orifice to chamber
7. Chamber safety valve
8. Jacket safety valve
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3.6. Chamber and Jacket
3.6.1. Chamber Ports
The chamber ports are located on the service side of the sterilizer.
This section illustrates the design and usage of chamber ports.
Chamber Port Design
Figure 29: Chamber Ports Usage

1. Load temperature sensor port (for optional open liquid program)
2. Temperature sensor port for validation
3. Pressure sensor port for validation
Parent ID
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3.6.2. Drain
Drain Module
The drain module connects the chamber with the vacuum pump for
draining.
Figure 30: Drain Module

1. Chamber condense line via orifice
2. Vacuum pneumatic valve
3. Bypass pneumatic valve
4. 3 ways pneumatic valve (drain or circulation tank)
5. Vacuum pump outlet
6. Vacuum pump inlet
7. Drain tank
Chamber has condense line as well via 1,5 mm orifice, which is used
in order to keep saturated steam in the chamber. When steam
becomes wet steam or water it goes to drain due to high pressure.
The line is connected directly to drain tank.
Parent ID
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3.6.3. Jacket
The jacket reinforces the chamber with welded channels. The

channels also heat the chamber with steam.
Jacket Top
Figure 31: Jacket Top

1. Steam connection
2. Safety valve connection
3. Steam connection (only used for big volume chambers)
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Jacket Bottom
Figure 32: Jacket Bottom
Drain port of jackets located at bottom, jacket pressure controlled by

steam trap.
1. Jacket drain port

2. Jackets middle connection each other
3. Jacket corner connection each other (same for each corner)
Jacket pressure changes according to chosen program, if low

pressure program has been chosen, pressure reducing can take
some time.
Parent ID
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3.7. Vacuum Unit
The sterilizer is equipped with a compact vacuum unit positioned at the

bottom of the stand. The unit is mounted on 4 rubber feet that are
screwed by nuts on two rails on the stand.
The vacuum unit consists of an electrical motor, a two-stage liquid ring
vacuum pump. The motor and the pump are attached together, where
the extended motor shaft serves as pump shaft. The shaft seal is
maintenance free and there is normally no need to disassemble the
motor and pump unit.
Figure 33: Vacuum Pump

1. Motor
2. Vacuum outlet
3. Pump
4. Vacuum inlet
5. Service water inlet
The vacuum pump uses service water to cool down itself during
operation, sterilizers has a circulation tank to provide service water to
vacuum pump. The system has water saving feature, which reduce
service water consumption. Circulation is only active during drying
phase.
During drying phase, if circulation tank water temperature is higher
than defined temperature high limit then 3 ways valve sends returned
service water to the drain line until circulation tank water temperature
reach to defined low limit.
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Figure 34: Vacuum Line Overview

1. Vacuum pump air bleeding line
2. Service water vacuum pump connection port
3. Air blending line connection
4. Service water solenoid
5. Service water flow control valve
Service water flow control valve should be adjusted, according to

vacuum pump performance.
If valve doesn’t provide enough water flow to pump, vacuum pump

temperature increases very quickly then it cannot reduce pressure
level until target level.
If valve provide more than enough water, which force the pump and
noise level and current requirements of vacuum pump becomes
higher.
Factory adjust service water flow valve half opened.

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Drain Tank
Figure 35: Drain Tank

1. Bypass pneumatic valve connection port
2. 3 ways pneumatic valve connection port
3. Steam trap
4. Steam trap
5. Chamber condense line connection
6. Manual drain valve
7. Drain tank water outlet
Parent ID
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3.8. Air Filter
Air Filter
The atmosphere air is filtered by a sterile filter before it enters the

chamber.
The filter and its housing is one disposable unit. Prolonged time for
pressure equalization might indicate that the filter is clogged and need
to be replaced at a shorter interval.
Figure 36: Air-in Filter F06

1. Air to chamber solenoid valve
2. Check valve
3. Air filter adapter
4. Air filter
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3.9. Electrical Power Cabinet
The electrical cabinet contains terminals, contactors and other high

voltage components.
WARNING
ELECTRIC SHOCK HAZARD
Turn off the power mains to the sterilizer, and lock and tag before
start working with the electrical equipment.
Figure 37: Electrical Cabinet Overview
NOTE
For more information please check electric project.
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3.10. Control System Hardware
The sterilizer is equipped with a Siemens S7-200 control system. This

chapter briefly describes the components of the control system.
For detailed information about the hardware installation, see the

Electrical Diagram.
For detailed information about the hardware components, see the
Hardware Design Specification or the manufacturer's documentation.
3.10.1. Controller Hardware
Figure 38: Controller Hardware

1. Single PT100 module
2. PLC module
3. Expansion module
4. Analogue input module
5. Multi-channel PT100 module
Supervisor Controller
Figure 39: Supervisor Controller

1. Single PT100 module
2. PLC module
Parent ID
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3.10.2. HMI Interface

The control system communicates with the user through touch screens
located at the sterilizer's fronts. The HMI devices are connected to the
control system's CPU by Ethernet.
Figure 40: Touch Panel Overview
1. Power connection
2. RS232 connection
3. USB connection
4. Ethernet connection
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Treatment Supervision The supervisor monitors and records chamber temperatures and
pressures during a process.
If the deviation of the readings are out of limits, the sterilization will be
reported as failed and alarms will be set.
The records from the supervisor are displayed in the process report.
Safety Interlocking
The supervisor has an interlock functionality that prevents the doors
from opening if the sterilizer is pressurized. For sterilizers with
programs for liquid loads, it also prevents door opening at risk of
boiling or explosion.
Supervisor Hardware
The supervisor hardware is located in the control cabinet.

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The sterilizer is equipped with a Siemens S7-1200 control system. The

functions of the software are accessed through menus on the control panel.
This chapter provides an overview of the control system's menus.
4. Screen Software
4.1. User Groups and Access Rights
User Group Description
Daily User Access to basic operation.
Access to all menus except

Super User
“Service” and “’s Settings”.
Access to all menus.

Service Personnel
User Groups Access Rights

- Daily Users
- Super User
- Service Access
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Daily Users Access

The following sections can be granted to the daily users.
Name Access Area
Custom Access to perform custom programs

Program
Access to standard programs defined

Programs
by software developer
Tests Access to the tests view
Menu Access to the menu
Time & Date Access to time & date settings view

Settings
Wake Up &
Night Off Access to the wake up & night off view
Values Access to the values view
Info Access to the info view
Log Out Log out of the software
Archive Access to the archive view
Super Users Access

Name Access Area
Standard Program Access to standard programs changeable

Settings parameters
Password Access to password managements section

Management of daily users
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Service Access
Name Access Area
Service Menu - Password Management
- Power saving settings
- Info
- Output Control
- Maintenance
- Air pump – Water pump
- Water Saving
- Other limits
- Calibration
Passwords Structure
- Optional settings
- Daily Users (up to 5 users)
- Super User
- Service
Service section has flexible password, when pressed to service

button. A key appears in order to enter to the section, this key
number will be used to generate specific password. For more detail
contact with after sales team.
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4.2. Menu
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The menu includes hardware and software control settings.

Accessible menus for daily users will be detailed below.
Figure 41: Menu
Pressure and temperature values are observed in values view.
Figure 42: Values Menu

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Wake – Up & Night Off
The Wake - Up & Night - Off feature allows for automatic start of
application specific functions such as heating, Air Leak Test and Bowie
Dick Test.
Hour and date is used to start a timer. This feature allows sterilizer to
do Bowie Dick Test and Air Leak Test. Also heating function runs if Leak
Test or Bowie Dick Test is chosen. To cancel Night - Off function, close
button can be used. For canceling Early Wake Up function, sterilizer
should be restarted.
Figure 43: Wake - Up & Night - Off View
Editing Wake-Up & Night - Off:

I. Tap Menu, then Wake - Up & Night - Off.
II. Enter the date and hour for early wake up.
III. Then tap SET button.
IV. For Night Off, close button can be used for controlling the
function.
V. Leak Test and/or Bowie Dick Test can be chosen by tapping
related buttons on the view. For sure heating function will be
activated if any of tests is chosen.
NOTE
Inactivate the Wake – Up & Night Off Function
To inactivate the Wake – Up & Night Off function, sterilizer should be
restarted. To cancel / activate Night Off function, Close / Open button
can be used.
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Archive
Figure 44: Time & Date View
Available functions of Archive Section
 Total number of records

 Re-printing of chosen record
 Graph view of recorded cycles
 Up and down allow to search other records
 Back to previous page
Figure 45: Graph View of Recorded Cycle

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Time & Date
This view is used for setting the date and time for the control system.
Figure 46: Time & Date Settings
Editing date and time:

I. Tap Menu , Then Time – Date Settings
II. Tap in the white input field.
III. Enter a new value.
IV. Tap Set.
Info
Figure 47: Info View
System Information Description

Sterilizer Name & Hospital Name -
Sterilizer Serial Number Unique Serial Number
Software Version & Date Unique Version

Cycle Count Number of Cycles Made
Last Bowie Dick Date and Time DD/MM/YYYY – HH:MM
Last Leak Test and Time DD/MM/YYYY – HH:MM
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Service
NOTE
Only authorized service technicians can enter service section with
flexible password.
Program Settings
NOTE
Custom program parameters can be changed only by authorized
service technicians with flexible password.
Figure 48: Changeable Parameters
 Drying time
 Drying pulse type
 Drying pulse quantity
NOTE
Standard programs parameters can be changed only by super user.
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User Log- Out
User log-out view. If “ok” is clicked, user will be log out of the system.
Figure 49: User Log-Out
Password Management
Figure 50: Users & Password
Change Password
Changing the users own password requires login by super user or
service technician.
Alarms and Messages

The Alarms & Messages appear on the screen directly. Continue
or Silence buttons can be used before fixing the fault.
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Print Last Cycle

Printer automatically prints out the last cycle after completion of
the sterilization process.
Print Test Page

After completing one of the tests (Bowie Dick or Air Leak), printer
automatically prints out the test document.
Print Alarms
Printer automatically prints out triggered alarms generated by the
control system as soon as the alarm occurs.
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Custom Program
Figure 51: Custom Program
Daily or Super users are not authorized to make any change in “Custom
Program Settings” section. Settings can be changed only by authorized
service representatives. Pre-defined can be run after activated by
service representatives.
WARNING
Warning risk of non-sterile items.
Program customization is only allowed to be done by authorized
Getinge service technicians.
WARNING
Custom programs are not type tested by Trans Medikal and might
require more extensive testing and validation before use by user.
WARNING
For custom programs with parameters set out-range of the original
factory program, the user undertakes the responsibility for the
program's regulatory compliance to directives or other national
regulations. Trans Medikal does not take any responsibility for the
sterilization result.
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Programs View
Figure 52: Programs View

1. Back Button
2. Enter Button
The Programs view is the sterilizer's start view. It includes available

sterilizer programs.
NOTE
134°C Prion, 121°C Open Liquid and Flash cycles are optional.
Tests
Figure 53: Tests View
Tests view includes “Bowie Dick” and “Air Leak” tests.
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Process Views
When a program is active and running, the Process Status is
displayed on the sterilizer's touchscreen.
Process Status is available in two layouts, Circle View and
Graphical View.
Circle view includes the name of the current program, the remaining
time of the program and buttons to access Menu and to abort the
program.
The Graphical View represents steps of the process in an another
way. It also has buttons to access Menu and to abort the program.
WARNING
Graphics records are only for overview.
Log table should be used for batch release.
Figure 54: Process Status Circle

Figure 55: Graph View of Recorded Cycle
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4.2.1. The Service Menu

The functions of the Service menu are protected by access
restrictions. Technical service responsible should contact with factory
for the service menu password.
Figure 56: Service Menu
The Service menu contains the following buttons:
1. Password Management
2. Power Saving Settings
3. Calibration
4. Info
5. Output Control
6. Maintenance
7. Air Pump & Water Pump
8. Water Saving
9. Other Limits
10. Factory Settings (not included in this manual)
11. Optional Settings
12. Logout
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Stepping in Programs
MenuServicePass Step
Figure 57: Pass Step View
Step skip feature can only be activated from the service menu.
- Step skipping can be performed after entering the service password.
- The doors remain closed at the end of the cycle when stepping is
skipped.
- In the case of step skipping, the printout shows “step is skipped” and
sterilization failed”.
- At the end of step skipping operation, “operation failed” screen
appears.
- Step skipping button is only active during the operation, in stand-by
mode it is disabled.
- Step skipping cannot be active during the drying phase and it

remains inactive until the drying phase is fully complete.
- During the heating and cooling phase in open liquid program, the
step skipping cannot be done.
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Password Management View
This menu enables service representatives to define user name

and password for daily users. Section includes super user,
flash cycle and cycle cancel passwords can be defined.
Five daily users and one super user password can be defined.
By pressing access password button, device start up password

can be enabled or disabled.
Figure 58: Password Management View
Power Saving Settings View
Device‘s stand-by function can be delayed by writing time as Seconds to

the “stand-by start delay box”. The time interval of buzzer sound is
determined by writing the period value as seconds to the “warning period
box”. - If 60 is written to the “warning period box”, buzzer will be activated
fo1 sec with 60 secs intervals. Stand-by can be enabled or disabled by
tapping “stand-by” button.
Figure 59: Power Saving Settings View
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Calibration View
Calibration menu consists of “pressure calibration“ and “PT100 calibration”.
Figure 60: Calibration View
Figure 61: Pressure Calibration View

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Screen column Description

Offset Plus or minus pressure difference
between sensor reading and the test
device showing.
Value=70mbar It is the value read by pressure

transducers at 70 mbar.
Value=3300mbar It is the value read by pressure

transducers at 3300 mbar.
Result Resultant value after offset is entered.
Figure 62: PT100 Calibration View
Screen column Description

First Value Value comes from PT100 sensor.
Offset Plus or minus temperature difference

between sensor’s measuring value and
test device (oil bath)’s value.
Result Value Resultant value after offset value is

entered.
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Info View
In this view :
- Machine / hospital name can be entered.

- Time and date can be set after entering values and then tapping
set button.
- System language can be chosen.
- End of cycle alarm options can be changed as; no alarm , 30
secs , 10secs / 2 min and continuously.
- Daily cycle can be reset.
Figure 63: Info View

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Output Control View
This menu enables service representatives to control below outputs,

monitor pressure and temperature values.
Outputs:
- Vacuum pump manual activation / deactivation

- Steam valve manual activation / deactivation
- Vacuum valve manual activation / deactivation
- Jacket valve manual activation / deactivation
- By – pass valve manual activation / deactivation
- Heaters manual activation / deactivation
- Air pump manual activation / deactivation
- Air valve manual activation / deactivation
- Water pump manual activation / deactivation
- Water saving valve manual activation / deactivation
- Gasket pressurization manual activation / deactivation
- Gasket pull back manual activation / deactivation
- There are also open / close buttons for front door. The labels on
buttons show motion information and position information of
the front door respectively.
- Note: If any output control button is pressed during it has

already been run , there will be red F indication on the up left
corner of the button. It means “Forcing”.
Figure 64: Output Control View

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Maintenance View
This menu enables service representatives to set maintenance periods
as number of successful cycles.
Recommended number of successful cycles for maintenance is as

below:
- Seal maintenance period is 3 cycles.

- Generator maintenance period is 200 cycles.
- General maintenance period is 50 cycles.
Figure 65: Maintenance View

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Air Pump & Water Pump View
This menu enables service representatives to set;
- Air pressure
- Air pump time fail limit (180 sec)
- Air pressure upper limit (7900 mbar)
- Air pressure lower limit (6700 mbar)
- Air pressure failure limit (6300 mbar)
Changing the status of external air button as active, air pump is

cancelled from the device.
By pressing control mode button, control type of air pump is chosen as

transmitter or switch.
Figure 66: Air Pump Settings View

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Water Saving View

In this view:
- Water saving and drain cooling can be enabled or disabled.

- Water saving tank and drain cooling upper temperature limits can
be entered.
- Water saving tank and drain cooling lower temperature limits can
be entered.
- Water saving tank and drain cooling valve can be controlled
manually.
Figure 67: Water Saving View

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Other Limits
This menu enables service representatives to set;
- Total cycle count

- Generator temperature limit
- Air leak test lower limit
- HMI IP
- HMI GW
- PLC IP
- Gasket pullback time
- Process error delay time
- Vacuum error time
- Steam error time
- Water pump time-out
- Process report time period
- Setup pressure
Figure 68: Other Limits View

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Optional Settings
This menu enables service representatives to modify below options ;
- Contactor control
- Generator temperature control
- Central steam
- Graph print
- Emergency stop
- Check sensor difference
- Gasket check
- Back screen
- Door type
- Custom program reset
- HMI setup
- Error records
- Standard programs
Figure 69: Optional Settings View
- Error number, occurrence date and time can be observed in “error

logs” view.
Figure 70: Error Logs View
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Standard Programs’ Parameters

Setting the standard programs’ parameters requires login by service
representatives. The Standard Programs view displays available
programs where the basic parameters for each program can be
changed.
Figure 71: Standard Programs View
Opening basic parameter editing:

1. On the Main menu, tap Menu, t h e n S e r v i c e , O p t i o n a l
S e t t i n g s a n d S t a n d a r d P r o g r a m s to open the Standard
Programs view.
2. Tap the parameter of related program to edit.
3. Tap back button to exit from the view.
- Allowed parameters of the related standard programs can be

changed in standard programs view.
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5. Preventative Maintenance
This chapter describes generic procedures for preventive maintenance.
Periodic maintenance of the sterilizer prevents underperforming
systems.
5.1. Pre-requisites and Maintenance Actions Overview
The pre-requisites for performing preventive maintenance on the

sterilizer includes the following items:
- Phosphoric acid based descaler

- Clamp ampermeter
- Multimeter
- Documentation of the latest performed validation
- Temperature reference instrument (heat source)
- Calibration oil bath
- Pressure reference instrument
- Pressure calibrater
- Teflon tape
- meter of 4mm air hose
- Getinge Assured Bowie Dick Test, or equivalent
The maintenance procedures and intervals stated here are generic.

Local regulations and specific maintenance plans that describe
additional procedures and intervals shall be complied with.
Parent ID
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5.1.1. PM Actions when Media and Power is Turned off

This list contains the PM Actions to perform when power and media are
turned off.
Turn off the power and all media before starting with the actions below.
Item Description Interval
Steam Generator, Empty the vessel and inspect for limescale if needed clean with 1000 cycles
Pressure Vessel water and use descaler to remove water residuals. or 1 year,
whichever
Note that the feed water tank needs to be emptied before comes first.
descaling the steam generator to prevent water leakage.
Steam Generator, Remove one of heating element if any signs of limescale or 1000 cycles
Heating Elements damages are visible, all heating elements shall be removed or 1 year,
and inspected, cleaned or replaced. whichever
comes first.
Steam Generator, Inspect the normal water level sensor for limescale using a 1000 cycles
Normal Water Level lighted inspection mirror, if necessary clean the sensor. or 1 year,
Sensor whichever
Check the thread sealing and replace if needed. When comes first.
assembling the sensor, the orientation mark on the sensor must
be vertical and facing upward.
Check the function of the sensor when refilling the steam

generator.
Steam Generator, Clean the tank, filter and verify the function of the float valve. 1000 cycles
Feed Water Tank or 1 year,
whichever
comes first.
Circulation Tank Clean the tank and verify the function of the float valves. 1000 cycles
or 1 year,
whichever
comes first.
Air-to-Chamber Filter Make sure the filter is properly connected. Replace the filter 350 cycles
(Model: TS 130) according to the specified interval. or 1 year,
whichever
comes first.
whichever
comes first.
whichever
comes first.
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whichever
comes first.
whichever
comes first.
whichever
comes first.
whichever
comes first.
whichever
comes first.
whichever
comes first.
whichever
comes first.
whichever
comes first.
Check Valves Disassemble and clean the parts. Replace the gasket. Verify 1000 cycles
that the kernel moves freely. or 1 year,
whichever
Perform the service on the following valves: comes first.
CV 701 Chamber Air
CV 702 Chamber Condenser
CV 703 Water Motor
CV 704 Condenser Tank Outlet
CV 707 Gasket Blow up
Strainers Disassemble, clean and inspect all strainers. Replace if 1000 cycles
damaged. or 1 year,
P 501 Separator Strainer whichever
P 502 Jacket Drain Strainer Chamber Condenser comes first.
P 503 Water Pump Strainer
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Restrictors Clean all restrictors on steam piping. Replace the restrictor if it is 2000 cycles
worn or damaged. or 1 year,
whichever
comes first.
Power Cables and High voltage cables. Make sure that the power to the sterilizer 2000 cycles
Connections is switched off before touching any power cables or or 1 year,
connections points, especially the incoming power cable to the whichever
machine, all contactors, heating element cable connectors comes first.
points and both earth and zero phase. Check that power
cables and connection points are tight and in good condition.
Contactor Replace the contactors label them with the replacement date. Contactor
Insert the date in the logbook and the PM protocol. K81-K82-
K83-K84:
2000 cycles
or 2 years,
whichever
comes first.
Other
contactors:
4000 cycles
or 4 years,
whichever
comes first.
Generator Heaters, Cables Check the resistance covers visually. If there is any physical 500 cycles
and Connectors deformation in the caps, the caps should be replaced with a or every 6
new one. If the covers do not fit into the resistance, the covers months,
should be replaced. whichever
comes first.
Check the looseness of the contactor connection and terminal
screws. Contactors should be tightened at 3.2N/m full
strength.
Check the heater energy cable connections (both the heater

and contactor connection points) visually. If there is
tarnishing, the connection lugs should be renewed. If there is
any deformation (tarnishing, oxidation, etc.) at the connection
points on the resistance, the resistance should be changed.
Door Gaskets Gaskets should always be replaced when performing 500 cycles
preventive maintenance on the machine to ensure that they or every 6
are in good condition. months,
During the replacement of the door gasket, use grease. whichever
6032280338 GREASE-DOOR GASKET OIL comes first.
Pressure Gauges Check that the pressure gauges are indicating within the 1000 cycles
acceptance range at atmosphere pressure. or 1 year,
whichever
comes first.
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Piston Valves Disassemble, clean and inspect the parts. If needed replace Steam
the gaskets and the seat seal. If the seat is damaged, replace valves:
the valve. Assemble and verify the function.
Sv101 Jacket Steam Valve 1000cycles

Sv104 Chamber Bypass Valve or 1 year,
Sv102 Chamber Steam Valve whichever
comes first.
Sv103 Vacuum Valve 2000cycles

or 2 years,
whichever
comes first.
Sv107 Water Saving Valve 3000cycles

or 3 years,
whichever
comes first.
Air Compressor Discharge water in the air compressor tank. 1000 cycles
Replace the compressor air filter, solenoid and check valve. or 1 year,
whichever
comes first.
Safety Valve Connection Check that the screws are not loose and make sure that the 1000 cycles
Port Kit part is not scaling. If the part is scaled, rinse with limescale and or 1 year,
then rinse with plenty of water. whichever
comes first.
Vacuum System Flush the vacuum pump sealent water tank to clean it. When noise
from the
pump or
poor
vacuum
performance
have been
reported.
Vacuum Pump Use the vacuum pump maintenance kit. Vacuum

pump water
leakage or
poor
vacuum
performance
have been
reported for
Azim Pump
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Vacuum Pump Change the vacuum pump with the new one. When its
damaged or
poor
vacuum
performance
have been
reported.
NOTE
Low water quality shortens the life of vacuum pump.
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5.1.2. PM Actions in Standby Mode

This list contains PM actions to perform when the sterilizer is in standby
mode.
Door, mechanical Verify that the motion of the door is even and smooth. Verify 1000 cycles
movement that the door does not brush against anything during its motion. or 1 year,
whichever
comes first.
Door, tolerance Check that the door gaps are 2 to 2.5 mm. 1000 cycles
or 1 year,
whichever
comes first.
Door Safety Bar Check the door's safety devices and functions: 1000 cycles
or every 1
Pinch protection. Check all corners and the middle of the months,
plate whichever
comes first.
Door Chain Check and adjust the door chains tightness. 1000 cycles
or 1 year,
whichever
comes first.
Door Components Check and tighten screws of door components and gear wheel. 1000 cycles
or 1 year,
whichever
comes first.
Vacuum Pump, Verify that there is water in the tank that supplies the vacuum 1000 cycles
Water Tank pump with sealant water. Check the function of the vacuum or every 1
pump's water level switch. months,
whichever
comes first.
Printer Check the status of the printer equipment. Make sure that there At every
is enough paper and that the toner cartridge or color band is in service
good condition. occasion.
Contactors All contactors: In case of an abnormal sound while working, 500 cycles
contactors should be replaced with new ones. or every 6
months,
whichever
comes first.
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5.1.3. PM Actions when Restarted

This list contains tests and actions to perform when starting up the
sterilizer at the end of the PM work.
Emergency Stop Run a test cycle on the machine and verify the function of the 1000 cycles
emergency stop button by pressing it during the cycle. Release or every 1
the emergency stop by inserting the key in the keyhole and year.
turning it clockwise until the stop button is released.
Steam Generator, Verify that the feed water pump refills the steam generator from 1000 cycles
Feed Water Pump the low level to normal level within 10 minutes and that there or every 1
are no leakage. year.
Leakage Inspect for leakage at piping components, connections, At every

heating elements and level sensors on the steam generator service
and process equipment. occasion.
Safety Valves For the chamber jacket and steam generator safety relief 1000 cycles
valves: Verify the function by open manually the valve's stem. or every 6
month.
In some countries, a yearly external inspection is mandatory.
Under all circumstances, the safety valve function needs to be
tested every 6 months by a Getinge certified technician
regardless of local regulations and rules.
Sensor Test Sensors to check: 1000 cycles

PT 601 Generator Temperature (PT 100 Single) or every
PT 602 Water Saving Tank Temperature year.
PT 605 Condenser Tank Temperature
PT 608 Chamber Temperature(80mm Double PT100)
PT 609Chamber Temperature(250mm Double PT100)
PT 610 Liquid(Load) Temperature
DEPO Saving Tank Temperature Module
JEN Generator Temperature Module
Check the temperature sensors values from screen. Ensure

that values are changing according to temperature of part.
If no verification of the system's temperature and pressure

sensors are performed during a preventive maintenance, it is
recommended to be performed in connection to validation or
yearly requalification.
Verification of the temperature sensors needs to be performed

at one or more of the process regulating temperatures, for
example 134°C (273,2°F). If the temperature readout deviates
more than +/-0,5 °C from the temperature reference, a
calibration needs to be performed.
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Leak Test Perform a leak test to make sure that there are no leakage in At every
the chamber. service
occasion.
Bowie & Dick Test Perform a Getinge Assured Bowie & Dick Test to verify the At every
sterilization process. service
occasion.
During the test, inspect the piping and components for leakage.
Make sure that cables and plastic or rubber hoses are not in
contact with hot parts of the sterilizer.
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6. Alarms and Messages
6.1. General
The sterilizer control system generates messages when an action is

required or a malfunction occurs. The messages are grouped into
categories:
- Process Information
- Alarms
- Information texts
- Start Conditions
Process Information The process status view displays information about the running
process.
If a process failure occurs, the process status view is replaced by the
Alarm view.
When the process completes, the process complete view indicates
whether it completed successfully or with failures.
Information Texts,
Warnings, Alarms Information texts alert the daily user to pertinent conditions. Warnings
and alarms appear on the display and are highlighted in red. The
message clears automatically when the condition is corrected.
Start Conditions Before a program can be started several start conditions have to be
fulfilled.
When a program is prevented from being started due to an unfulfilled
start condition, the blocking condition is printed in the middle of the
program view.
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6.2. System Alarms and Messages
The Location of the

Reference Measurement Point
This section is a reference to be used when alarms and messages
are set on the sterilizer.
According to the EN 285 7.1.3, the reference measurement point
has been determined in such a way that throughout the plateau
period the temperature at this point correlates with the temperature
in the usable space.
The temperature relationship between the reference measurement
point selected and the drain line identified as the coolest part of the
usable space has been determined.
This section is a reference to be used when alarms and messages

are set on the sterilizer.
No. Fault description Cause Action

101 Vacuum pump phase If any phase failure conditions or Check the 3 of phases, ensure
protection relay has been in case of changing the order of that there is no missing connection
activated any phase this alarm is activated or pump direction is correct.
by the PLC Controller.
(Maintenance, electrical changes
etc. may cause the phase
sequence to change.)
102 Vacuum pump thermic If the current drawn from the main Check the current of vacuum
relay supply by the vacuum motor pump, ensure that pump electrical
exceeds the predetermined rated motor is not stuck.
current, this alarm is activated by
the PLC Controller.
103 Reserved N/A N/A
104 No water in water tank If there is not sufficient water in Check the signal of water level
water tank, this alarm is activated sensor, ensure that cables are
by the PLC Controller. connected.
105 Generator high pressure If the generator pressure values Check the heater contactor,
exceed 4.1bar (abs), this alarm is pressure transmitter, slim relays of
activated by the PLC Controller. PLC outputs and pressure switch
of generator.
106 Jacket high pressure If the jacket pressure reaches 3.5 Check the pressure transmitter,
bar, this alarm activated by the switch and pneumatic valve.
PLC Controller.
107 Water level sensor fail If the generator low and high- Check the electronical float up and
level signals trigger the PLC low limit switches, cables
concurrently, this alarm is connection. If needed adjust the
activated by the PLC Controller. screws of switches.
Water pump time – out
108 If the water pump does not fill the Check the slim relay and contactor
generator in the predetermined of water pump. Measure the
time, this alarm is activated by the voltage while water pump on.
PLC Controller.
109 Generator Low water If the liquid level relay does not Check the LLR relay and probe
level (LLR) detect water in the generator, this cable connections.
alarm is activated by the PLC
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Controller.
110 Low air pressure or no air If the air pressure does not reach Check the pressure transmitter or
to predetermined range in 2 pressure switch of air comp.
minutes, this alarm is activated by
the PLC Controller.
111 Door motor thermic relay If the current drawn from the main Check the door motor current.
has been activated supply by the door motor exceeds
the predetermined rated current,
this alarm is activated by the PLC
Controller.
112 Circulation tank does not If the circulation tank is empty or Check the level sensor of
have water fault the water level is less than circulation tank and cable
required, this alarm is activated by connection.
the PLC Controller.
113 Generator water level is If the generator is empty or water Check the water pump and
low level less than required, this error generator float valve. Ensure that
is activated by the PLC Controller. all the cables connected tighten.
114 Air pump time – out If the air pressure does not reach Check the air pump release cable
the working range pressure limit in connections and pressure
the predetermined time, this alarm transmitter.
is activated by the PLC Controller.
115 High temperature in the If the generator exceeds the Check the heater contactors, PLC
generator predetermined high-temperature output and water pump.
limit, this alarm is activated by the
PLC Controller.
The default high level is 155 oC.
116 Generator Contactor Fail If the PLC receives a "generator Check the heater contactors and
contactor active" signal although signal cable
the PLC does not send start
commands to the heaters, this
Controller.
201 Steam timeout error If the chamber pressure does not Check the PLC output and
reach to the set pressure value in pneumatic valve of steam supply
predetermined duration, this alarm to chamber.
202 Vacuum timeout error If the chamber pressure does not Check the vacuum pump
reach to the set pressure value in movement and contactor.
predetermined duration, this alarm
will be activated by the PLC
Controller.
203 Low sterilization If any temperature sensor of the Check the temperature calibration
temperature error controller or supervisor reads of chamber. Ensure that there is
chamber temperature lower than no leakage between relevant parts
sterilization temperature during on the chamber.
the sterilization period, this alarm
204 Load sensor not placed If the load sensor is not placed to Check the load PT100 position.
the liquid load, this alarm is Ensure that the PT100 located
activated by the PLC Controller. correctly top of the load.

205 Low gasket pressure If the gasket pressure switch does Check the pilot valve of gasket.
not send a signal for 5 seconds Ensure that not leaking. Check the
during the process, this alarm is door gasket and vacuum solenoid
activated by the PLC controller. valve of gasket.
206 High sterilization pressure If any pressure sensor of the Check the steam supply valve of
controller or supervisor reads chamber.
chamber pressure higher than
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sterilization pressure during the

sterilization period, this alarm is
activated by the PLC controller.
207 Pressure deviation If the difference between chamber Check the pressure calibration of
between controller and pressure sensors more than transmitters. Check the
supervisor pressure 30mbar during the sterilization communication cable of controller
sensors phase, this alarm is activated by and supervisor.
the PLC controller.
208 Low sterilization pressure If any pressure sensor of the Perform a leak test check the
controller or supervisor reads result. If there is leak check all the
chamber pressure lower than relevant parts. Check the pressure
sterilization pressure during the transmitter.
sterilization period, this alarm is
activated by the PLC controller.
209 Cycle Canceled If the user cancels the cycle, this N/A
controller.
210 Temperature deviation If the difference between chamber Check the temperature calibration
between controller and temperature sensors more than of transmitters. Check the
supervisor pressure 0.5°C during the sterilization communication cable of controller
sensors phase, this alarm is activated by and supervisor.
the PLC controller.
211 Sterilization time If the difference between Check the communication cable
deviation between calculated sterilization times by connection between supervisor
controller and supervisor controller and by supervisor more and controller.
pressure sensors than %1 of sterilization phase, this
controller.
212 Emergency button If the emergency stop button is N/A

activated pressed, this alarm is activated by
the PLC controller.
213 Supervisor If the controller does not Check the ethernet cable of
communication communicate with the supervisor, supervisor, supervisor PLC.
this alarm is activated by the PLC
controller.
214 Jacket low pressure error If jacket pressure lower than Check the jacket pressure
nominal pressure, this alarm is transmitter, jacket pneumatic valve
activated by the PLC controller. and slim relay of jacket pneumatic
valve.
215 High pressure deviation If the difference between chamber Check the pressure calibration of
between controller and pressure sensors higher than transmitters.
supervisor 200mbar, this alarm is activated
216 High temperature If the difference between chamber Check the temperature calibration
deviation between temperature sensors higher than of transmitters.
controller and supervisor 3°C degrees, this alarm is
activated by the PLC Controller.
217 High sterilization If any temperature sensor of the Check the temperature calibration.
Temperature controller or supervisor reads Ensure that PT100 is location is

chamber temperature 3°C higher same as factory settings.
than sterilization temperature
during the sterilization period, this
Controller.
218 Air leak test pressure If the difference between chamber Check the pressure calibration of
deviation pressure sensors more than controller and supervisor
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30mbar at first 15 seconds of the transmitter.

air leak test, this alarm is activated
219 Drying pulse timeout at If chamber pressure cannot reach Check the air solenoid valve and
vacuum to target value with in 5 min during steam pneumatic valve of
drying pulse, this alarm is chamber and vacuum pump
activated by the PLC Controller. performance.
220 Drying pulse timeout at If chamber pressure cannot reach Check the air solenoid valve and
(Air / Steam) to target value with in 5 min during steam pneumatic valve of
drying pulse of air or steam, this chamber and vacuum pump
alarm is activated by the PLC performance.
Controller.
221 Pressure equalization If chamber pressure cannot reach Check the air solenoid valve.
timeout to atm pressure within 10 min at Ensure that air solenoid valve not
the end of the process, this alarm blocked.
If the gasket pressure decrease Check the gasket pressurization
under the set value 10 times line and gasket check valve.
during sterilization process
222 Gasket leak air (related to data coming from the
gasket pressure switch), this
Controller.
271 Generator pressure If the generator pressure sensor Check the pressure transmitter of
sensor error value is out of range, this alarm is generator and cable connections.
activated by the PLC Controller. Check the generator pressure
calibration.
272 Jacket pressure sensor If the jacket pressure sensor value Check the pressure transmitter of
error is out of range, this alarm is jacket and cable connections.
activated by the PLC Controller. Check the jacket pressure
calibration.
273 Chamber pressure sensor If the chamber pressure sensor Check the pressure transmitter of
error value is out of range, this alarm is chamber and cable connections.
activated by the PLC Controller. Check the chamber pressure
calibration.
279 Air pressure sensor error If the air pressure sensor value is Check the connection of pressure
out of range, this alarm is transmitter.
281 Chamber temperature If the chamber temperature sensor Check the connection of
sensor error value is out of range, this alarm is temperature transmitter.
282 Drain cooling temperature If the drain cooling temperature Check the connection of
sensor error sensor value is out of range, this temperature transmitter.
Controller.
283 Generator temperature If the steam generator Check the connection of
sensor error temperature sensor value is out of temperature transmitter.
range, this alarm is activated by
the PLC Controller.
284 Circulation tank If the circulation tank temperature Check the connection of
temperature sensor fail. sensor value is out of range, this temperature transmitter.
Controller.
291 Chamber supervisor If the chamber supervisor Check the connection of pressure
pressure sensor error pressure sensor value is out of transmitter and supervisor.
range, this alarm is activated by
the PLC Controller.
292 Chamber supervisor If the chamber supervisor Check the connection of
temperature sensor error temperature sensor value is out of temperature transmitter and
range, this alarm is activated by supervisor.
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the PLC Controller.

You cannot use the front If the device is in process, this Wait until end of the process
301
door during the operation warning occurs.
The front door lift down If both of the buttons are Check the door switches and
and lift up buttons cannot activated, this warning occurs. connections
302
be pressed at the same
time
If the sensor does not detect the Check the front door sensor
The position sensor of
303 front door position, this warning
front door is faulty
occurs.
If the closed sensor is active, this Check the front door sensor
304 Front door closed
warning occurs.
If the opened sensor is active, this Check the front door sensor
305 Front door opened
warning occurs.
There is a pressure in the If the gasket channel has Check the vacuum valve of gasket
306 gasket, door cannot be pressure, this warning occurs. channel and pilot valve of gasket
opened
If the front door open button is Check the vacuum valve of gasket
Gasket pressure is
307 pressed during the gasket channel and pilot valve of gasket
discharging. Please wait
discharging, this warning occurs.
Front door motor timeout If the door does not open within 20 Check the sensor, contactor and
308
error sec., this warning occurs. relays of the door motor
Front door cannot be If the back door sensor not detect Check the door sensors
opened when the back the door, this warning occurs.
309 door is open. Please
close the back door and
try again
Open liquid program If the front door is activated when Check the open liquid load sensor
safety lock enable. it is attempting to open and liquid
310
Door(s) cannot be safety lock is on, this warning
opened occurs.
When the door is open, If safety plate sensors are Check the sensors
311 front door safety switch is activated, this warning occurs.
on
During the operation, If safety plate sensors are Check the sensors
312 front door safety switch is activated, this warning occurs.
on
You cannot use the back If back door open button is Check the back door open button
326
door during the operation activated, this warning occurs.
The back door lift down If both of buttons are activated, Check the door switches and
and lift up buttons cannot this warning occurs. connections
327
be pressed at the same
time
The position sensor of If the sensor does not detect the Check the back door sensor
328 back door is faulty back door position, this warning
occurs.
If the closed sensor is active, this Check the front door sensor
329 Back door closed
warning occurs.
If the opened sensor is active, this Check the front door sensor
330 Back door opened
warning occurs.
There is a pressure in If the door is tried to be opened Check the vacuum valve of gasket
331 gasket, the door cannot while the gasket has pressure, this channel and pilot valve of gasket
be opened warning occurs.
If the door is tried to be opened Check the vacuum valve of gasket
Gasket pressure is going
332 during the gasket vacuum, this channel and pilot valve of gasket
to discharge. Please wait
warning occurs.
If the door motor does not reach Check the sensor, contactor and
Back door motor timeout
333 the upper or lower limit within 20 relays of the door motor.
error
seconds, this warning occurs.
334 Back door cannot be If the front door sensor not detect Check the door sensors.
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opened when the front the door, this warning occurs.

door is open.
Open liquid program If the back door is tried to be Check the open liquid load sensor
safety lock enable. opened when the liquid safety
335
Door(s) cannot be switch is on, this warning occurs.
opened
When the door is open, If safety plate sensors are Check the sensors
336 back door safety switch is activated, this warning occurs.
on
During the operation, If safety plate sensors are Check the sensors
337 back door safety switch is activated, this warning occurs.
on
You cannot open the If back door button is activated Check the back door button
338 back door during the during the cycle, this warning
operation occurs.
Chamber pressure is high If the gasket pressure higher than Check the pilot valve of gasket
for the gasket vacuum. the normal value, this warning
351
Gasket vacuum couldn’t occurs.
done.
If the back door open button is Check the vacuum valve of gasket
Gasket pressure is pressed during the gasket channel and pilot valve of gasket
352
discharging. Please wait. discharging, this warning occurs.
If the gasket pressure lower than Check the gasket and vacuum
No pressure in the gasket
353 the normal value, this warning solenoid of gasket
or insufficient.
occurs.
If contactor continuously activated, Check the contactors
361 Heater contactor failure
this warning occurs.
If the interlock is not activated Check the interlock mechanism
Liquid program security
when the load temperature
365 lock is not on. Heating
exceeds 95oC, this warning
process is stopped.
occurs.
Liquid program security If main PLC cannot receive reset Check the interlock mechanism
lock is not on. signal from interlock mechanism
366
Cooling step can not after load sensor falls below 95oC,
complete. this warning occurs.
General maintenance N/A N/A
377
time
If the steam valve output active Check the gasket ready relay is
but signal can not oparete valve active, back door and front door
Media Interlock Activated!
due to failure on the interlock are closed.
385 Steam Valve Out of
chain this alarm is given by the
Function!!
PLC controller.
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6.3. Daily
Cleaning area Detergent to use Cleaning method

Stainless steel surfaces on the A microfiber cloth and 70% ethanol Be careful when cleaning painted
outside of the sterilizer surface disinfectant. surfaces, labels and plastic parts.
The control panel surface, buttons, A microfiber cloth and 70% ethanol For stains from grease, fat, oil, or
and manometers surface disinfectant. soap
The touchscreen A microfiber cloth and 70% ethanol Lightly wiping

surface disinfectant.

The inside of the chamber A lint free cloth moistened with Details see below
including the door gasket demineralized water. instructions
If discoloration or stains are found
inside the chamber or on the door
gasket, contact a local service
technician.
The strainer in the chamber floor Manually remove contaminations
drain (paper, indicators) see below
instructions
If difficulties in cleaning the
strainer, contact a local service
representative.
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Cleaning the Control Panel Surface The control panel surface is made of a white, solid and homogeneous
material that requires daily cleaning.
Stains on the control panel surface from grease, fat and oil are
removed with a microfiber cloth and a mild abrasive cleaning agent,
the panel is then cleaned with a microfiber cloth and a 70% ethanol
surface disinfectant and wiped dry.
Stains on the control panel surface from soap, minerals and hard water
scales are removed with a standard lime-scale remover, the panel is
then cleaned with a microfiber cloth and a 70% ethanol surface
disinfectant and wiped dry.
Cleaning the touchscreen Lightly wipe the touchscreen from side to side with a clean and dry
microfiber cloth. Stubborn stains are removed with a microfiber cloth
and a 70% ethanol surface disinfectant. Never apply pressure when
cleaning. Never use circular cleaning motions or apply any type of
liquid or cleaning product directly to the touchscreen when cleaning, as
this can damage the liquid crystals inside the screen.
Cleaning the Chamber
WARNING
Hot Surface
The sterilizer must cool down before cleaning. Before cleaning, turn
off the sterilizer and allow to cool, for example overnight.
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WARNING
Do not enter into the chamber for cleaning or any other purpose.
1. With the sterilizer in standby mode, open the sterilizer door by

tapping the Open Door button.
2. Turn the Interlock Key to the locked position and remove the
key. Keep the key with you while working inside the chamber.
3. The sterilizer door is blocked and chamber preheating is shut
off.
4. Control the strainer in the chamber floor drain and manually
remove any contaminations (like papers or indicators). If
difficulties in removing any contaminations from the strainer,
contact a local service technician.
5. After cleaning, insert the Interlock Key in the key switch and
reset to initial position.
6. Close the sterilizer door by tapping the Close Door button.
6.4. Weekly

The inside of the chamber A lint free cloth moistened with Details see below
demineralized water. instructions
Discoloration or stains inside the Contact a local service
chamber representative.
The load carriers Preferably cleaned and disinfected
in a washer-disinfector
see below instructions
Cleaning the Chamber
WARNING
Hot Surface
The sterilizer must cool down before cleaning. Before cleaning, turn
off the sterilizer and allow to cool, for example overnight.
WARNING
Risk of Injury
Do not enter into the chamber for any purpose.
1. With the sterilizer in standby mode, open the sterilizer door

by tapping the Open Door button.
2. Turn the Interlock Key to the locked position and remove the
key. Keep the key with you while working inside the chamber.
ð The sterilizer door is blocked and chamber preheating is
shut off.
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3. Remove any shelves, rails, guides and bottom plates and

clean the inside of the chamber.
4. After cleaning, insert the Interlock Key in the key switch and
reset to initial position.
5. Run a steam-process to thoroughly rinse the system and
wash away any citric acid residues.
Cleaning Load Carriers
Stainless steel load carriers, such as containers, baskets and shelf

racks are preferably cleaned and disinfected in a washer-disinfector, or
by hand with a microfiber cloth and 70% ethanol surface disinfectant
and water.
7. Shutdown
This chapter describes manual shutdown and automatic hibernation of
the sterilizer.
Manual Shutdown
1. Turn off the ON/OFF switch located in front of the sterilizer.
2. If the sterilizer shall be off for a period longer than 48 hours: Close
the valves for air, water and steam (if used).
Night-off As an alternative to manual shut downs and start ups, the sterilizer
can be set to automatic night off and wake up by timers.
With activating night off function before the sterilization process starts,
the sterilizer turns off itself after sterilization finishes.
Figure 72: Wake – Up & Night Off View

The sterilizer can be waked by activating Early Wake – Up option.
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Setting the Early Wake - Up and Night off Option
There is no restriction for anyone who logs on to the system.
Figure 73: Early Wake Up & Night Off View is Now Displayed.
1. On the Main Menu, tap Menu, Wake up & Night off.

2. Select the Night off. After sterilization finishes, Night – Off
automatically turns the system off.
3. Select the date and hour and tap Set.
4. Optionally, set the Wake up timer by repeating step 2 and 3 with
applicable settings.
Night - Off and Early Wake - Up Option with Leak Test
With the Sterilizer Wake – Up & Night –Off option, the Early Wake –
Up can be used to;
Setting the Early Wake - Up

• Perform a full blow down of the steam generator to rinse it from
deposits
• Switch off the jacket heating and the steam generator to
save energy
• Wake up the sterilizer at set time
• Warm the sterilizer up
• Run a Leak Test and Bowie Dick Test program. (Optionally)
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Setting the Early Wake - Up requires login by anyone.

There is no restriction.
1. On the Main Menu, tap Menu, Wake – Up & Night - Off.
2. Early Wake – Up date and hour can be chosen from this view.
Figure 74: Early Wake Up & Night Off View
Select the hour and date when the sterilizer shall wake up. Then
tap the Set button.
Checking the Air Leak Test

Settings
The optional Air Leak Test program is controlled by settings in the

Wake – Up & Night - Off program.
Figure 75: Wake Up & Night Off View is Now Displayed.

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1. On the Main menu, tap Menu , Wake – Up & Night - Off and
open the Wake - Up & Night - Off view.
2. Tap Leak Test to change status from passive to active.
Figure 76: The Early Wake Up View, is Now Displayed
3. Check that the Leak test parameter is changed as Active.

4. If the parameters are not set correctly, call for a service
technician with authority for extended parameter editing.
5. It is also same for the Bowie Dick Test , too.
8. Program Combination
WARNING
EXPLOSION HAZARD
Liquids must not be processed in this sterilizer except optional
open liquid program.
Processing of liquids with improper programs may cause
explosions or burns.
WARNING
RISK OF CROSS CONTAMINATION
Do not process hazardous waste in this sterilizer.
NOTE
The maximum operating temperature ranges between 134°C and

137°C.
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8.1. The Sterilization Process
8.1.1. Steam Sterilization
The steam sterilization process can be divided into three main

phases:
Figure 77: Main Phases and Pressure Profile of a Typical

Steam Sterilization Process
a. Pre-treatment
b. Sterilization
c. Drying
Pre-treatment
The presence of moisture is one of the most important conditions when

killing microorganisms with heat. In a steam sterilization process, the
steam must be brought into very close contact with the microorganisms.
To do this, the air in the chamber must be almost totally evacuated.
The pre-treatment phase is designed to evacuate the air in the chamber

and its goods gradually until its influence is no longer significant. This is
achieved through a series of vacuum pulses which may be alternating
with steam pulses.
Sterilization
The sterilization phase starts when the chamber temperature exceeds
the target sterilizing temperature and finishes when the predefined
sterilization time elapses.
An alarm is set if the chamber temperature sensor registers a value

outside the temperature tolerances.
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Post-treatment
The purpose of post-treatment is to normalize the temperature and
moisture content of the goods. All goods except liquids are subjected to
a sub atmospheric pressure deeper than 200 mbar for a certain time
period.
The weight increase of textiles caused by steam moisture will be

approximately 1% of total weight after the post-treatment.
Before the process finishes, a pressure equalization to atmospheric

pressure is achieved by admitting filtered air to the chamber. The filter
prevents bacteria from entering the chamber and has an efficiency of
99.998% for particles larger than 0.3 microns (0.0003 mm) in size.
The sterilizer chamber is kept closed by the door seal until the chamber
reaches atmospheric pressure.
8.2. Parameter Information
Figures
The figures in the descriptions illustrates the chamber pressure profile

during the process.
8.3. Programs
134C Textile
For sterilization of medical devices, e.g. textiles, utensils.
NOTE
Pressure rate of change does not exceed 10bar/min (145psi/min)
Program parametproer Range Default
a Negative pressure pulses – 4
b Positive pressure pulses – 4
Sterilization temperature (C) – 134

Figure 78: 134C Textile Process c
Sterilization time (min) – 5
d Drying 10
Air / Steam Pulse 0 - 10 0
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121C Rubber
For sterilization of medical devices, e.g. rubber and plastic utensils.
NOTE
Program parameter Range Default

c
Figure 79: 121C Rubber Process
d Drying 15
134C Instruments
For sterilization of medical devices, e.g. instrument, utensils.
NOTE

c
d Drying 15

Figure 80: 134C Surgical Process
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125C Rubber
For sterilization of medical devices, e.g. rubber and plastic utensils.
NOTE

c
d Drying 15
Figure 81: 125°C Rubber
134°C Prion (Optional)
Prion program is a program designed to kill germs that can not be killed
in standard programs. Sterilization time was determined as 134°C 18
minute according to WHO / CDS / CSR / APH / 2000.3 (Annex III 2.6
page 28) of the world health organization.

c
Figure 82: 134°C Prion
d Drying 10
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121°C Open Liquid Program (Optional)
Open liquid program is used to sterilize laboratory type liquid

materials in fully open or vented containers.
- Temperature probe should be placed on the container
that has the largest volume
- Make sure that probe is inserted into the container and
has direct contact with the liquid as illustrated in Figure
73.
- The maximum allowed volume for liquid is 1L /container
Figure 83: Illustration of Probe Position
NOTE
Open liquid program should not be used to sterilize the
materials to be used on patients.
NOTE
Liquid loads should not be filled above the specified values for
containers.
Program parameters Range Default
a Vacuum – 1
b Purge – 1
c Heat Up – –
d Sterizliation Temperature – 121

(°C)
Sterilization Time(min) – 20
e Cooling – –
f Drying 20
Figure 84: 121°C Open Liquid Process 0 - 10 0
Air / Steam Pulse
NOTE
Usable volume of open liquid program is maximum 10 % of total volume
of devices.
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Flash Program (Optional)
NOTE
A flash cycle is only intended for a small amount of unwrapped and
uncomplicated instruments. It is not regulated by EN 285 and password
protected to prevent anyone from using it for normal wrapped goods or
for routine sterilization.

c
Figure 85: Flash Program
d Drying 1
WARNING
Flash process for single, open instrument password required. A flash
process for e.g. single, non-wrapped instruments. Check medical items
manufacturer declaration before sterilization.
WR WARNING
Flash Program is not designed in accordance with EN285 and must not
be used for routine sterilization of medical devices.
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Custom Programs
There are additional custom programs (password required) available;

Control unit has 99 adjustable programs.
Sterilization temperature (C) 121-134 134

c
Sterilization time (sec) 1-99 5
d Drying 0-99 5
Air / Steam Pulse 0
0 - 10
Figure 86: Custom Program
WARNING
Program customization is only allowed to be done by authorized
Getinge service technicians.
WARNING
Custom programs are not type tested by Trans Medikal and might
require more extensive testing and validation before use by user.
WARNING
For custom programs with parameters set out-range of the original
factory program, the user undertakes the responsibility for the
program's regulatory compliance to directives or other national

regulations. Trans Medikal does not take any responsibility for the
sterilization result.
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Bowie Dick Test

Intended application: Test of steam penetration capability at a Bowie
Dick Type Package.
Either use a disposable Bowie dick test pack in accordance with EN
ISO 11140-4 or a standard test pack with an indicator paper in
accordance with EN ISO 11140-3.

c
Sterilization time (min) – 3.5
d Drying Time (min) – 5

Figure 87: Bowie Dick Test
NOTE
This is a test program which not shall be used for sterilization.
Leak Rate Test
Intended application: Test for chamber leakage.

The test shall be performed with a warm and empty chamber.

a Evacuation (mbar) – 50
b Stabilization (sec) – 300
c Leak test (sec) – 600
d Max accepted leak rate (bar/min) – 0.0013
Figure 88: Leak Test Process

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8.4 Automatic Generator Discharging

Automatic generator discharging is an optional process that is
processed automatically by the control unit instead of the operator with
a specified routine generator discharging process. Discharging process
is done by a pneumatic valve.
The automatic generator discharging option can be activated or
passivated as a factory setting.
When the specified number of cycles is completed, the automatic
discharging is initiated by the control unit at device startup. After started,
the process can be cancelled by the operator. Also, it can be started
manually from the manual control menu, which is located in the system
settings.
Manual Control and Starting Manual Discharge Process
Menu > Service > Manual control
1. Manually opens and closes the generator discharge valve

2. Manually starts the generator discharging process
Automatic Discharging Process

In the periods determined according to Generator Maintenance Period,
automatic discharging process is started automatically one time at the
first starting of the device. The factory setting is 1 time in every 50
cycles. The period can be changed by the technician (Menu > service
> maintenance).
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It can be canceled within 1 minute after the cleaning process started. In

case of the cancellation, it will be restarted automatically at the next
opening.
Automatic Discharging Process Steps

a. Water is filled to the generator.
b. Generator pressure is increased to 2500mbar.
c. Until the generator pressure reaches 1300mbar, the discharging
valve opens and closes with pulse.
d. After 1300 mbar, the valve opens for 5 min.
e. Water is filled to the generator (in this process, the water motor
timeout is 9 minutes. It becomes 3 minutes after the filling process
is completed.
During the discharging process, the following error situations related to

the generator are cancelled temporarily.
- Generator low water level error
- Generator liquid level sensor error
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Recycling and Scrapping

This chapter describes how to recycle or scrap the sterilizer and its
parts.
Recycling of Metal Components
WARNING
Heavy parts
When dismounting the sterilizer's doors or chamber, make sure
they are properly supported to avoid crushing accidents.
Many of the sterilizer's metal components, like the chamber and

the piping, are directly involved in the sterilizing process and might
be contaminated if the last run sterilization failed. Before scrapping
or recycling, make sure that the last run sterilization completed
successfully or that the sterilizer has been sanitized in order to
eliminate infectious contaminants.
Recycling plastic components
Plastic details are marked with international codes and shall be

sorted according to the marking when recycled.
Legal Manufacturer:
Ahi Evran OSB Mah. Kırımhanlığı Cad.
No: 6A /1 Sincan/Ankara Türkiye
Tel:+ 90 312 385 77 20
Fax: +90 312 385 25 50

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TR-SM-B-EN rev08 Service Manual for 4.

4 Series Page: 1 of 124

Castle / Trans Smart Steam Sterilizer

3.9. Electrical Power Cabinet ........................................................................ 60

4.2.1. The Service Menu................................................................................. 78

Water leakage may cause a conductive path from live electrical

Do not process hazardous waste in this sterilizer.

Maintenance and repair of the sterilizer are to be performed by trained

Trans Steam Sterilizers are designed to sterilize “Medical Items” suitable

The sterilization process is applicable for pore or non-porous, heat and

The following user documentation is supplied with the sterilizer:

The symbols indicate a warning, an attention or a note.

Symbols in this Manual

Warning burn hazard, hot

The equipment, parts of the

Warning pinch hazard.

The equipment or parts of the

Warning shock hazard.

Warning risk of non-sterile

Warning, risk of injury.

Warning explosion hazard.

Warning chemical hazard.

Warning fire hazard.

Symbols on the Sterilizer

The following symbols on the sterilizer informs users of possible

Warning about unauthorized

Before start up sterilizer do not

Please evacuate antifreeze

Do not try to operate doors

Before loading the trolley on

Please approach carefully.

The note symbol alerts the

Unauthorised person shall not

Medical device directive.

1.1. Contact Information

Trans Medikal Service

1.2. Machine Identification

Figure 1: Product label

Figure 2: Vessel and Jacket Pressure Label

Figure 3: Generator Pressure Label

2.1. Product Liability

Modifications to the equipment without the explicit approval of Trans

2.2. Safety Precautions

Read the Manual

The sterilizer is designed with a number of built-in safety devices. To

The operator should have well understood and be able to implement

This equipment or system has Class I protection, it must be connected

Make sure that the device is connected to correct voltage.

Operation of the sterilizer is prohibited while paneling is opened or as

Malfunctions and leaks (for example, a worn door gasket) shall be

Keep the sterilizer clean to ensure optimum performance.

Do not hose down the outside of the sterilizer with water.

Authorized persons are responsible for training the operators.

The operator is obliged to promptly inform the authorized persons of

It is prohibited to remove or disable the safety devices.

Never dismantle or disassemble the sterilizer.

High voltage points within the device are dangerous.

Shut off the Mains power, if it is impossible to disconnect the device

Keep the area around the sterilizer clean and dry.