GSS67H SERIES SEMINSA BAA083178
SERVICE MANUAL
Any and all intellectual property rights, including but not limited to copyright, inventions (whether patentable or not), trademarks, design, know-how and proprietary information, in and to this manual, or as disclosed therein, are owned by or licensed to Getinge, and nothing in this manual shall be construed as assigning any such intellectual property rights or rights to any person. This means inter alia that this manual may not be reproduced in whole or in part, or distributed or otherwise made available in any form or by any means, without the written prior approval of Getinge. If additional copies of this manual are required, such copies may be purchased from Getinge at such price as Getinge applies from time to time. © Copyright 2014 GETINGE, All rights reserved. Getinge Sterilization AB Ekebergsvägen 26 305 75 Getinge Sweden Telephone: +46 (0)10 335 0000 Fax: +46(0)35 54952 email:
[email protected] Internet: www.getinge.com Information Product ID: 0000000400, ver. install Item no. install
Item ver. install
Date: 2017.11.17 14.8.15 ORIGINAL INSTRUCTIONS
Service Manual
Table of contents | 5
TABLE OF CONTENTS Index of warnings............................................................................................................................................ 8 1
Preface 1.1 Contact Information......................................................................................... 14
2
Safety 2.1 Product Liability............................................................................................... 15 2.2 Safety Precautions........................................................................................... 15 2.3 Safety Features................................................................................................ 16 2.3.1 Safety Interlocks...................................................................... 18 2.4 Mandatory Reporting....................................................................................... 18 Description 3.1 P&I Diagram Legend........................................................................................ 20 3.2 Generic Components....................................................................................... 24 3.2.1 Strainers.................................................................................. 24 3.2.2 Piston Valves........................................................................... 26 3.2.3 Safety Relief Valves................................................................. 30 3.2.4 Pressure Gauges..................................................................... 32 3.2.5 Check Valve Maintenance....................................................... 33 3.2.6 Restrictor Maintenance............................................................ 34 3.2.7 Pilot Valves.............................................................................. 35 3.2.8 Air Hoses and Connections..................................................... 38 3.3 Doors................................................................................................................. 38 3.3.1 Double Door Sterilizers............................................................ 39 3.3.2 Opening the Sterilizer's Front.................................................. 41 3.3.3 Door Pinch Protection ............................................................. 42 3.3.4 Measuring the Door Gap......................................................... 43 3.3.5 Adjusting the Door Speed........................................................ 44 3.3.6 Adjusting the Door Lock........................................................... 46 3.3.7 Replacing the Door Gasket...................................................... 48 3.3.8 Prolonging the Gasket's Service Life....................................... 51 3.4 Water Supply.................................................................................................... 51 3.4.1 Tank B16................................................................................. 53 3.5 Steam Equipment............................................................................................. 55 3.5.1 Steam Generator..................................................................... 55 3.5.2 High Temperature Protection................................................... 57 3.5.3 Pressure Transmitter............................................................... 58 3.5.4 Feedwater Pump..................................................................... 58 3.5.5 Blowdown Equipment.............................................................. 61 3.5.6 Steam Piping........................................................................... 64 3.5.7 Steam Trap.............................................................................. 65 3.5.8 Steam Trap Maintenance........................................................ 66 3.6 Chamber and Jacket........................................................................................ 68 3.6.1 Chamber Ports......................................................................... 68 3.6.2 Jacket...................................................................................... 70 3.7 Drain.................................................................................................................. 71
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3.7.1 Removing the Drain Module.................................................... 73 3.7.2 Calibrating the Positioner......................................................... 73 3.7.3 Replacing the Drain Bleeder Check Valve............................... 75 3.8 Vacuum Unit..................................................................................................... 76 3.8.1 Cleaning of Heat Exchangers.................................................. 80 3.9 Air Filter............................................................................................................ 81 3.10 Electrical Power Cabinet............................................................................... 82 3.11 Sensors........................................................................................................... 83 3.11.1 Chamber Pressure Sensor PE05.......................................... 83 3.11.2 Boiler Pressure PE06............................................................ 85 3.11.3 Supervisor Chamber Pressure Sensor PE29........................ 85 3.11.4 Chamber Temperature Sensor TE00.................................... 86 3.11.5 Jacket Temperature Sensor TE01......................................... 87 3.11.6 Condenser Temperature Sensor TE04.................................. 88 3.11.7 Drain Jacket Temperature Sensor TE07............................... 89 3.11.8 Supervisor Chamber Temperature Sensor TE24.................. 89 3.11.9 Troubleshooting Sensors and AI Signals............................... 90 3.12 G1 Control System......................................................................................... 91 3.12.1 Operator Panel...................................................................... 91 3.12.2 Power and Bus Modules........................................................ 91 3.12.3 I/O Modules........................................................................... 94 3.12.4 Supervisor............................................................................ 100 3.12.5 Data and Printer Connections ............................................. 104 3.12.6 The Access Management System....................................... 106 3.12.7 Touchscreen Overview........................................................ 112 3.12.8 Progress Views.................................................................... 115 3.12.9 The Select Program View.................................................... 116 3.12.10 Menus................................................................................ 118 3.12.11 Settings Menu.................................................................... 119 3.12.12 Documentation Menu......................................................... 122 3.12.13 Alarms and Messages Menu............................................. 123 3.12.14 Creating a Software Backup.............................................. 124 3.12.15 Restoring the Sterilizer's Software..................................... 124 3.12.16 Program Management....................................................... 131 Preventive Maintenance 4.1 Prerequisites ................................................................................................. 151 4.2 PM Actions when Media and Power is Turned Off...................................... 152 4.3 PM Actions when Restarted.......................................................................... 154 4.4 Safety Checks................................................................................................. 156 4.4.1 Door Mechanism Safety Checks........................................... 157 4.4.2 Emergency Stop Button Safety Checks................................. 160 4.4.3 Interlock Safety Checks......................................................... 161 4.4.4 Safety Relief Valve Checks................................................... 162 4.4.5 Steam Generator Safety Checks........................................... 163 4.5 Cleaning.......................................................................................................... 165 4.6 Validation and Performance Qualification................................................... 167
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5
Troubleshooting 5.1 Water Quality.................................................................................................. 169 5.1.1 Feedwater Quality.................................................................. 170 5.2 Alarms and Messages................................................................................... 170 5.2.1 General.................................................................................. 170 5.2.2 System Alarms and Messages.............................................. 171 5.3 Detecting Leaks.............................................................................................. 184
6
Process Overrides 6.1 Manual Interventions in the Process............................................................ 186 6.2 Stepping in Programs.................................................................................... 186 6.3 Power Failure Alarm with Door Open........................................................... 187
7
Validation 7.1 Modification of Program Parameters at Validation..................................... 189
8
Recycling and Scrapping
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Index............................................................................................................................................................. 191
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Index of warnings | 8
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 Hazards Inside the Service Area The service area shall only be entered by personnel informed about the hazards inside it. When working in the service area or behind panels, be aware of risks of injury by:
crushing
pinching
burning
high noises (hearing impairment)
live electrical equipment
WARNING RISK OF INJURY - COMPRESSED SPRINGS There is a risk of injury when removing the valve body or actuator, as both contains compressed springs.
WARNING Risk of Explosion If the pressure adjustment seal of a safety valve is broken, the opening pressure may have changed. Safety valves with broken seals must not be used.
WARNING BURN HAZARD AND HEARING IMPAIRMENT RISK
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When testing the safety valves there is a risk of burns or hearing impairment. Use appropriate personal protective gear to avoid injury and wear protective gloves when operating the valve. Keep away from the outlet of the safety relief valve when lifting the valve.
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Index of warnings | 9
WARNING MANUALLY ACTUATING THE CONTROL VALVES When manually actuating the control valves, the sterilizer's safety systems are set aside. The valves shall only be acutated by technicians who are thoroughly familiar with the process, the properties of the load and the functions of the sterilizer and it's components. The technician has to decide which operations that can be done and if any precautions shall be taken
WARNING SECURING THE DOOR Before performing any work on the door, ensure that it is correctly supported to avoid crush or pinch injury.
WARNING Risk of Crushing Be very careful if the door remains fastened to the seal. When the door is detached from the seal it will fall down and may cause injury.
WARNING PINCH INJURY There is a risk of pinch injury when working close to the door latch.
WARNING SECURING THE DOOR When replacing the door gasket, turn off the power and disconnect the compressed air supply to ensure that the door cannot close or move when work is in progress.
WARNING RISK OF CRUSHING After the travel limitation block has been removed, step back when opening the door to avoid crush injury below the door.
WARNING HEAVY COMPONENT Beware of heavy component. Use appropriate equipment when handling the component to avoid injury.
WARNING ELECTRIC SHOCK HAZARD
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Turn off the mains power to the sterilizer, and lock out and tag out before starting to work with the electrical equipment.
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WARNING RISK OF ELECTRIC SHOCK The terminal block must only be allowed to conduct voltage when it is inserted. It must not under any circumstances be removed or inserted when voltage is applied or have voltage applied to it when it is removed.
WARNING Non-sterile Goods The sterilizing result depends on proper pre-treatment with effective vacuum pulses. The vacuum limit parameters must not be raised to compensate for reduced vacuum pump performance.
WARNING Fire Hazard Excessive drying may cause the goods to catch fire. Test changes to heating and drying related parameters early in the program development and stay clear of the door when opening the sterilizer.
WARNING Non-sterile Goods Changes to process parameters affect the sterilizing result. Consult the client's decontamination manager for re-validation and performance qualifications after changing process parameters.
WARNING Misuse of program types may jeopardize both the personnel's safety and the sterilization result. Make sure that the intended application for the custom program complies with the intended application for its program type. Read the intended application for the factory program to copy before creating a custom program. Also read the Intended Use and the contraindications stated in the User Manual.
WARNING HOT SURFACE The door and the chamber can be hot and may cause burns. The sterilizer must cool down before cleaning. Turn off the sterilizer and allow to cool, for example overnight.
WARNING BYPASSING SAFETY OPTIONS
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With the stepping option, a technician can under certain circumstances manually bypass built-in safety conditions.
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WARNING HEAVY PARTS The doors and chamber are heavy and can cause injury by crushing.
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When dismounting the sterilizer's doors or chamber, make sure they are properly supported to avoid crushing accidents.
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Preface | 12
Preface Before using the sterilizer, read all instructions and become familiar with the design, safety features and operation of the unit. Getinge Sterilization AB 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 User
This manual is intended for authorized Service Technicians. They are trained for their tasks and when so required, certified for their scope of work. The Service Technicians are familiar with national and local requirements and laws.
The following user documentation is supplied with the sterilizer:
Symbols in this Manual
User Manual
Installation Manual
Service Manual
Quick Guide plus Program Combination
Technical Data Sheet
The symbols indicate a warning, an attention or a note. To emphasize the importance of warnings, instructions and advice in this manual, the following categories are used to draw attention to them.
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Related Publications
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Preface | 13
Symbols in the Manual:
Description: 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 consequences of not letting the equipment complete its cycle. Warning, risk of injury.
Warning explosion hazard.
Warning chemical hazard.
Warning fire hazard.
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.
The following symbols on the sterilizer informs users of possible hazards.
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Symbols on the Sterilizer
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Symbol:
Description: Warning, risk of injury.
Warning shock hazard. Electrical danger.
Warning burn hazard. Hot surface or heat emitting area.
Warning pinch hazard. The equipment or parts of the equipment could pinch or crush.
Warranty
The warranty for the equipment is handled by Getinge's representative in each country. For warranty issues, please contact your local Getinge representative.
1.1 Contact Information Getinge Service
If additional help is required, contact an authorized Getinge service representative: www.getinge.com/contact us
Getinge Sterilization AB Ekebergsvägen 26 305 75 Getinge Sweden +46 (0) 10 335 0000
[email protected]
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Manufacturer Address
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Safety | 15
Safety
2.1 Product Liability Modifications to the equipment without the explicit approval of Getinge Sterilization AB, 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. Before installing or performing repairs or maintenance on the machine, service personnel must study the manuals and referred documentation.
Authorized Personnel Only WARNING Hazards Inside the Service Area The service area shall only be entered by personnel informed about the hazards inside it.
Electrical Safety
crushing
pinching
burning
high noises (hearing impairment)
live electrical equipment
Read all instructions thoroughly before using the sterilizer.
Installation and service maintenance must be performed by qualified service personnel trained on this sterilizer.
The sterilizer must be operated by personnel who has the proficiency and training for this type of machine.
Personnel must participate in regular periodic training on the operation and maintenance of this equipment, in accordance with established procedures for the workplace.
The front panels and the electrical cabinet may be opened by authorized and trained service personnel only.
Be sure to switch OFF the electric power before opening front panels and any electrical cabinet.
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When working in the service area or behind panels, be aware of risks of injury by:
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Safety | 16
Hot Surfaces and Pipes
Restricted Access
Other Considerations
The sterilizer must be connected in accordance to the installation instructions and local safety codes.
If electric arc welding is necessary on or in proximity to the sterilizer, disconnect all wiring connected by terminal blocks or plugs and sockets from all circuit boards of the control system.
There are hot surfaces in the service area. Never touch any piping that could contain steam.
The sterilizer uses steam, which can cause burns or serious injuries. Wear personal protective equipment suitable for hot water and steam.
Always keep the door to the service area locked to prevent access of unauthorized personnel.
Operation of the sterilizer is prohibited while panelling is opened or as service personnel are inside in the service area.
Never tamper with or bypass the door limit switches of the sterilizer.
When servicing the machine, turn the door interlock key to the locked position. Remove the key and keep it with you.
Malfunctions and leaks (for example, a worn door gasket) shall be checked or repaired by a service technician without delay.
Keep the sterilizer clean to ensure optimum performance.
Do not hose down the outside of the sterilizer with water.
2.3 Safety Features Safety Components The sterilizer includes components intended to ensure personal safety. These components are marked with a warning symbol on or close to the component and in the following documents: 0000000689
Figure 1: Warning
Electrical diagrams
Piping diagrams
Parts lists
Sound Pressure Level
For information about the sound pressure level, see the Technical Data Sheet.
Sound Power Level
For information about the sound power level, see the Technical Data Sheet.
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These components have undergone special tests before being accepted as safety components. For this reason, they must not be replaced with components of any make or design that has not been approved by Getinge. 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.
Service Manual
Emergency Stop
Safety | 17
The emergency stop button is a safety feature that will prevent hazardous situations, both while running a program and in standby mode.
0000004958
Figure 2: Emergency stop button with key 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. Use the key to unlock and reset the emergency stop button. For security reasons, it is not possible to lock the button when it is not activated. NOTE The emergency stop button cuts the power to the sterilizer and the equipment connected to the machine's power supply, such as automatic loader/unloader.
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.
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Protective Plates
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Door Crush Protection
The entire surface of the top edge of the door is covered by a steel plate. It deflects when pressure is applied from above, wherever the pressure is applied, and forces the door to move downwards.
Pressure Vessels
The sterilizer chamber, the jacket and the steam generator are pressure vessels, designed and built according to regulations and codes at the country of installation.
Valves
Electrically - and pneumatically - controlled valves are spring loaded. If 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. Because of different code requirements, the safety valves may or may not be supplied with the sterilizer.
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 both by a hardwired system and as software functions redundantly.
Door Opening Interlock
If the pressure in the chamber is above or below atmospheric pressure, the door cannot be opened.
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 Getinge sterilizer must be reported immediately in writing.
Causing serious deterioration in the health of a person
Those which might cause serious deterioration in the health of a person
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Report the following circumstances:
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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
Send the written report by letter, fax or email to: GETINGE STERILIZATION AB For the attention of: Quality Manager Box 69 305 05 GETINGE Sweden Fax: +46 (0)35 549 52 Telephone: +46 (0)10 335 0000 Email:
[email protected]
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5.
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Description | 20
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:
Heat exchangers Symbol
Explanation Plate heat exchanger
Tube heat exchanger
Pumps and ejectors Symbol
Explanation Centrifugal pump
Liquid-ring vacuum pump
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Ejector, jet vacuum pump
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Description | 21
Motors and fans Symbol
Explanation Fan, radial blower
Electric motor
Filters Symbol
Explanation Gas filter
Gas filter in housing
Strainer Membrane degassing filter
Instruments, general Symbol
Explanation Instrument
Instrument, panel-mounted
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Instrument, local control panel in service area
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Indicators Symbol
Explanation Pressure indicator
Temperature indicator
Sensors and switches Symbol
Explanation Pressure emitter
Temperature emitter
Pressure switch
Temperature switch
Float actuated level switch
Valves Symbol
Explanation Pneumatic piston-actuated seat valve
Pneumatic piston-actuated seat valve, continuously operated
Pneumatic piston-actuated ball valve
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Pneumatic piston-actuated globe seat valve
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Description | 23
Symbol
Explanation Solenoid valve
Solenoid three-way valve
Manually-actuated flow valve
Pressure regulator
Float-actuated angle valve
Flange, tri-clamp
Check valve, flow direction towards right
Safety valve, spring-loaded
Miscellaneous symbols Symbol
Explanation Tank, container
Bottle, tank, container
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Separator, water reservoir
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Description | 24
Symbol
Explanation Rupture disc between tri-clamp (sanitary) flanges
Fixed restriction Adjustable restriction
Steam trap
Silencer
Unidirectional speed control valve
Pneumatic actuated block valve with spring return (unidirectional/bidirectional)
Single-acting single-ended pneumatic cylinder with spring return Single-acting single-ended pneumatic cylinder pressurized through piston rod
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.
0000000808
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Figure 3: Strainer symbol.
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Description | 25
1 Strainer Body 2 Strainer screen 3 Cap
Cleaning a Water Strainer
1 Strainer Body 2 Strainer screen 3 Cap 1.
Unscrew the cap and remove the screen.
2.
Clean the screen by brushing it while flushing it with water.
3.
Reassemble.
4.
When the sterilizer is back in use, verify that the assembly does not leak.
1.
Unscrew the cap and remove the screen.
2.
Clean the screen by brushing it while flushing it with water.
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Cleaning a Steam Strainer
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Description | 26
3.
Reassemble.
4.
When the sterilizer is back in use, verify that the assembly does not leak.
Cleaning the Chamber Strainer
0000005851
Figure 6: Strainer 1 Strainer 1.
Remove the allen screw and remove the strainer.
2.
Clean the strainer by brushing it while flushing it with water.
3.
Reassemble.
3.2.2 Piston Valves
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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. In the P&I diagram, normally open valves are marked with N.O. and normally closed valves are unmarked as this is the most common type.
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Description | 27
0000000616
Figure 7: Piston valve 1 2 3 4 5 6 7 8
Open/Close indicator Connector for actuator Union nut Gasket Seat seal gasket Valve body Spindle nut Spindle
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.
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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.
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Restoring Piston Valves WARNING RISK OF INJURY - COMPRESSED SPRINGS There is a risk of injury when removing the valve body or actuator, as both contains compressed springs.
NOTE There are two types of piston valves; N.O. (Normally Open) and N.C. (Normally Closed). Inactivated N.O. valves have a red indicator on top of the actuator. The N.O. valve is also marked in the P& I diagram with the letters N.O. above the valve symbol. The piston valves shall be maintained regularly to prevent leakages. The actuator has to be disassembled from the valve body, the gasket and the seat seal shall be inspected or replaced and the seat surface in the valve body inspected for any damage.
0000000616
Figure 8: Valve mechanism 1 2 3 4 5 6 7 8
Open/Close indicator Connector for actuator Union nut Gasket Seat seal gasket Valve body Spindle nut Spindle
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Restoration Procedure
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Description | 29
1.
2.
3.
For normally closed valves, see “Disassembling a N.C. Valve” on page 29
For normally open valves, see “Disassembling a N.O. Valve” on page 30
Inspect the seat surface in the valve body.
If the surface is intact, replace the gasket (4) and seat seal gasket (5).
If the surface is damaged, the complete valve must be replaced.
Reassemble the valve on the machine:
For normally closed valves, see “Reassembling a N.C. Valve” on page 30
For normally open valves, see “Reassembling a N.O. Valve” on page 30
Normally closed valves has to be in opened position when disassembled, for withdrawing the spindle releasing the spring force on the union nut. Opening the valve is done by connecting compressed air to the actuator. As the pilot pilot valve YV16 and YV23 can be locked into the open position, any of these can be used as compressed air source during this procedure. Optionally, the temporary air hose can be connected to any other source of compressed air that can be locked into open position.
0000006441
Figure 9: Sliding switch operated pilot valves 1 YV23 2 YV16
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Disassembling a N.C. Valve
Disassemble the valve from the machine:
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Description | 30
1.
Note the direction the connector is positioned as the actuator has to be positioned in the same way when reinstalled.
2.
Disconnect the control air hose to the valve's actuator (2) and connect a temporary air hose instead.
3.
Connect the other end of the temporary air hose to the control valve YV16. If YV16 is used already, first mark the existing hose and disconnect it temporarily.
4.
Set YV16 to the open position so the actuator opens the valve. ð This withdraws the spindle and releases the force on the union nut.
5.
Unscrew the union nut and disassemble the valve mechanism from the body.
6.
Close YV16.
1.
Note the direction the connector is positioned as the actuator has to be positioned in the same way when reinstalled.
2.
Disconnect the air supply to the actuator.
3.
Unscrew the union nut and disassemble the valve mechanism from the body.
1.
Set YV16 to the open position.
Disassembling a N.O. Valve
Reassembling a N.C. Valve ð This withdraws the spindle and makes it possible to assemble the valve into the body. 2.
Place the valve mechanism in the body in the same position as before and tighten the union nut.
3.
Close YV16, remove the temporary air hose from the actuator and reconnect the original control air hose.
4.
Remove the temporary air hose from YV16. If any other air hose was connected to YV16 before this procedure, reconnect it.
1.
Place the valve mechanism in the body in the same position as before and tighten the union nut.
2.
Reconnect the air supply to the actuator.
Reassembling a N.O. Valve
3.2.3 Safety Relief Valves
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The sterilizer might have several safety relief valves.
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Description | 31
Possible safety relief valve locations are at the:
Steam generator
Jacket
Chamber
For specific information, see the P&I diagram of the sterilizer.
EU model
0000003416
Figure 10: Safety relief valve 1 2 3 4
Seal for pressure adjustment Lifting device, screw-operated Steam outlet Steam inlet
NOTE The valve may differ in size and format.
The safety relief valve's pressure adjustment is set by the manufacturer and then sealed. For safety valves with intenal pressure adjustment mechanism, the seal is not visible pn the outside of the safety relief valve. If the seal has been broken, replace the valve as its opening pressure might have been changed. WARNING Risk of Explosion If the pressure adjustment seal of a safety valve is broken, the opening pressure may have changed. Safety valves with broken seals must not be used.
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Seal for Pressure Adjustment
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Exercising a Safety Valve WARNING BURN HAZARD AND HEARING IMPAIRMENT RISK When testing the safety valves there is a risk of burns or hearing impairment. Use appropriate personal protective gear to avoid injury and wear protective gloves when operating the valve. Keep away from the outlet of the safety relief valve when lifting the valve. Safety relief valve can be exercised by manually open it to blow off steam. This can be done as a basic function check or for cleaning the seat surfaces by blowing away any dust or impurities. ATTENTION RISK OF CONTAMINATION The safety relief valve shall only be lifted when pressurized. Lifting a non-pressurized safety relief valve may let dust or dirt in to the valve.
Closing a Leaking Safety Relief Valve WARNING BURN HAZARD AND HEARING IMPAIRMENT RISK When testing the safety valves there is a risk of burns or hearing impairment. Use appropriate personal protective gear to avoid injury and wear protective gloves when operating the valve. Keep away from the outlet of the safety relief valve when lifting the valve.
ATTENTION RISK OF CONTAMINATION The safety relief valve shall only be lifted when pressurized. Lifting a nonpressurized safety relief valve may let dust or dirt in to the valve. Safety valves might leak if dust or dirt get trapped in the valve's seat. Lifting the valve while it is pressurized might blow the dirt away. If the valve still leaks after lifting, the seat might be damaged. Replace the valve. For detailed information about safety valves, see Chapter 3.2.3 “Safety Relief Valves” on page 30.
3.2.4 Pressure Gauges
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The pressure gauges on the sterilizer have a marked accuracy acceptance range that the gauge shall be within in atmosphere pressure.
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0000005640
Figure 11: Pressure Gauge 1 Accuracy acceptance mark.
3.2.5 Check Valve Maintenance The check valves are of the Y-type; the pressure opens the valve by lifting the kernel from one direction and closes the valve by pressing the kernel towards it's seat from the other.
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Y-type
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Description | 34
0000000658
Figure 12: Check valve 1 2 3 4 5
Flow inlet Seat gasket Kernel Cap Flow outlet
1.
Unscrew the cap and lift the kernel.
2.
Inspect that the seating areas are clean and undamaged.
3.
Replace the seat gasket and reassemble the kernel.
4.
Verify that the kernel moves lightly in the valve and screw the cap back on.
3.2.6 Restrictor Maintenance 1.
Locate the restrictors by searching for the symbol on the P&I diagram. The diameter of the restriction is shown next to the symbol in the piping diagram, or in the piping diagram parts list.
2.
Disassemble the restriction and clean it with a wire or rod of suitable dimension. A drill may be used if it is carefully turned by hand. If a drill is used, the drill´s diameter must not be larger than the stated diameter of the restrictor orifice.
3.
Reassemble the restriction.
4.
When the sterilizer is back in use, verify that the assembly does not leak.
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For each restriction, proceed as follows:
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Description | 35
3.2.7 Pilot Valves
0000005049
Figure 13: Pilot valve The pilot valves are assembled by double valve units (2 valves in each unit) mounted on a manifold with air connections and X2X fieldbus connected to the control system. It is very important to observe extreme cleanliness when working with pilot valves. Make sure that dirt or gasket residue does not enter the valve ducts. Foreign particles in the valves may block the valve in the open position and cause faulty operation, so that open doors close or media valves accidentally open. When in doubt if a valve has been soiled internally, replace the valve.
Manipulating the Pilot Valves WARNING MANUALLY ACTUATING THE CONTROL VALVES
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When manually actuating the control valves, the sterilizer's safety systems are set aside. The valves shall only be acutated by technicians who are thoroughly familiar with the process, the properties of the load and the functions of the sterilizer and it's components. The technician has to decide which operations that can be done and if any precautions shall be taken
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A process valve can be actuated by opening the air supply from its pilot valves manually. The pilot valves opening mechanism can either be a spring loaded push button or a slide switch (valves YV16 and YV23 only).
0000003718
Figure 14: Push button pilot valves
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1 Pilot valve 2 Push button opening mechanism
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Description | 37
0000006441
Figure 15: Sliding switch pilot valves 1 Sliding switch Valve B 2 Sliding switch Valve A
Humming Pilot Valves
1.
On the pilot valve block, identify the pilot valve for the process valve to manipulate.
2.
Open the valve as described below: Push button valve
Slide switch valve
With a small screwdriver, push in the pilot valve's opening mechanism and keep it pushed in as long as you want to actuate the process valve.
Slide the switch to the forced open position. The valve now remains open until it is set back to its automatic mode again.
The opening mechanism is spring loaded and closes automatically when it is released.
When finished, set the switch back to the auto position.
The pilot valves are actuated by solenoids. Humming sounds from a solenoid valve may be a forewarning of overheating due to abnormally high electric current through the solenoid. In general, an alternating current rises when the circuit impedance decreases and this happens when the solenoid is no longer surrounded by a closed iron circuit. An air gap in the magnetic circuit could be caused by dirt preventing the armature from reaching its end position when the solenoid becomes energized.
1.
Turn off the compressed air supply.
2.
Unscrew the top left and bottom right screw and pull the valve unit straight out of the manifold.
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Removing and Installing Pilot Valves
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Description | 38
3.
If a solenoid is faulty, unscrew the top cover from the valve unit and replace the solenoid. If the pneumatic parts of the valve is faulty, replace the valve unit.
4.
Reinsert the valve into the manifold and tighten the screws.
5.
Turn on the compressed air and check that the controlled functions work as intended.
3.2.8 Air Hoses and Connections ATTENTION DIFFERENT HOSE MATERIAL The black air hoses are made of TPH (Polyolefin) and the translucent air hoses are made of PTFE (Polytetrafluoroethylene). Make sure to use a hose of appropriate material when replacing. The hoses are connected to the components by one-touch fittings. ATTENTION When dismounting or mounting components with air hose fittings, be careful to not apply bending forces to the hose fittings as they may break.
Replacing Air Hoses
0000002517
Figure 16: One-touch fittings.
1.
Make sure that the hose is not pinched by the pliers. The end of the hose must be round and with a straight cut.
2.
Push the hose firmly into the fitting until it stops. Pull back on the hose to ensure that it is gripped.
3.
To disconnect the hose, push down on the collect flange, hold down and withdraw the hose.
3.3 Doors
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This chapter describes the functions of the door and the door gasket that seals between the door and chamber during process.
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3.3.1 Double Door Sterilizers Door Opening Mechanism
0000001873
Figure 17: Control diagram for the doors. FV04, FV05 FV00, FV01 R04, R05 XR04, XR05 HX04, HX05 XR00, XR01 HX00, HX01 E1/1, E1/2
Door closing valve Door locking valve Pneumatic actuated block valve with spring return. Speed control valve Door closing cylinder, single acting Speed control valve Door locking cylinder, spring loaded Silencer
It is only possible to open one door at a time. The doors are closed by single-acting cylinders and opens by their own weight when the pressure is released from the cylinder.
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A squeeze protection is integrated in the top of each door. The top surface of the door is covered by a steel plate, which when pressed down, opens a release valve at the cylinder's pressure chamber, which opens the door as the air in the cylinder is let out.
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When a door is completely closed, the spring-loaded cylinder locks the door. The lock activates a switch which makes it possible to pressurize the door seal and start the process. As the locking cylinder is spring-loaded and needs compressed air to unlock, the door remains locked in case of power or air supply failure. The door remains locked until safe pressure and load temperature is achieved, even if an electrical fault results in an opening command.
Door Gasket –Sterilizers without CCB This section descibes the door gaskets for sterilizers without CCB (Cross Contamination Barrier)
Door Gasket
The seal between the door and chamber is formed by a silicone gasket in a groove around the opening of the chamber. The gasket is pressed against the door by steam, compressed air or an inert gas. The media used depends on the type of sterilizer. Before the door is opened, the gasket is retracted into the gasket groove by vacuum. In the groove, behind the gasket, a coil spring prevents the gasket from blocking the vacuum port.
Sealing and Unsealing the Chamber
When a program starts, the gasket pressure valve FV20 opens and presses the gaskets towards the doors and seals the chamber. Before opening a door, the gasket vacuum valve FV02 opens and the gasket is sucked back into the groove, releasing the pressure from the door.
The pressure switch PS71 monitors the pressure in the door gasket grooves. If the pressure should fall below prescribed value, the valves for the media supply to the chamber closes and sets the alarm Door seal failure alarm. See the electrical circuit diagram for detailed information about the interlock system.
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Gasket Pressure Monitoring
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Gasket Bottom Pneumatics– Standard
0000001765
Figure 18: Gasket Bottom , standard 1 2 3 4 5 6
Gasket groove connection Gasket vacuum valve FV02 Gasket air pressure inlet, from PCI22 Gasket pressure valve FV20 Gasket groove connection Pressure switch PS71
3.3.2 Opening the Sterilizer's Front WARNING SECURING THE DOOR Before performing any work on the door, ensure that it is correctly supported to avoid crush or pinch injury.
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To access the door mechanism and the door gasket, the sterilizer's front must be opened.
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Description | 42
1.
Unlock the security lock located at the bottom of the front.
2.
Pull the front out from the sterilizer to release it from the snap locks and turn it sideways.
3.3.3 Door Pinch Protection A pinch protection is integrated in the top of the door. The top surface of the door is covered by a plate, which when pressed down opens a release valve at the door cylinder. The release valve shall then let air out at a higher rate then let in to the cylinder, which causes the door to open again.
1
2 3
0000008133
Figure 19: Pinch protection 1 Pinch protection plate 2 Release valve 3 Door cylinder
Checking the Door Pinch Protection 1.
Close the door.
2.
While the door closes, push down the middle of the pinch protection plate.
3.
Repeat the test for the corners of the pinch protection plate. ð The door shall open again anywhere the plate is pressed down. Otherwise, adjust the door closing speed, see Chapter 3.3.5 “Adjusting the Door Speed” on page 44
The pinch protection release valve is set from factory, but might need adjustment if the door cylinder is replaced.
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Adjusting the release valve
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Description | 43
1
2
3
4
5
0000008006
Figure 20: Door opening release valve (pinch protection plate is removed) 1 2 3 4 5
Adjustment screws (x4) Plate fastening screws (x4) Release valve plate Release valve actuator Release valve to cylinder fastening screws (x3)
1.
Unscrew and remove the pinch protection plate.
2.
Loosen the plate fastening screws (2).
3.
With the adjustment screws (1), adjust the height of the release valve. Raising the valve increases the sensitivity and lowering decreases the sensitivity.
4.
Tighten the plate fastening screws.
5.
Reassemble the pinch protection plate.
3.3.4 Measuring the Door Gap With the door closed and no pressure on the door gasket there shall be a gap of 2 to 2.5 mm between the door and the gasket groove.
Use a 2 mm thick measuring gauge made of teflon plastic or any other smooth material that does not damage the door gasket for verification of the door gap. The gauge shall fit in the slots on the side of the door.
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Measuring equipment
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0000004144
Figure 21: Door gap 1 Gauge slot (in total 4 slots, 2 on each side of the door) 2 Adjustment screw (in total 8 adjustment screws, 4 on each side of the door)
Measuring procedure 1.
Open the sterilizer's front. see Chapter 3.3.2 “Opening the Sterilizer's Front” on page 41.
2.
Make sure the door is closed and that the door gasket is retracted to the groove.
3.
Carefully insert the measuring gauge in the slots on each side. The gauge shall fit easily, but not with a larger gap than 0.5 mm. ð The gap shall be between 2 and 2.5 mm. If not, turn the adjustment screws until the gap is within the tolerated clearance.
3.3.5 Adjusting the Door Speed
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The time for the door to close shall be between 10 and 20 seconds. If the door closing is set to high speeds, the door pinch protection might not work as intended.
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Description | 45
4
5 1 3 2
0000007536
Figure 22: Door closing components 1 Pneumatic actuated block valve with spring return R04 (R05 for door on non-control side) 2 Door latch speed control valve XR00 (XR01 for door on non-control side 3 )Door closing speed control valve XR04 (XR05 for door on non-control side) 4 Lock nut on speed control valve 5 Speed control screw For detailed information about the door closing function, see Chapter 3.3 “Doors” on page 38.
1.
Open the locknut (4) on the door closing speed control valve (3).
2.
Close the speed control valve (5) completely.
3.
Open the speed control valve four turns.
4.
Make sure that the door closes in 10-20 seconds and that the door opens again when the pinch protection plate is pressed down.
5.
If not, adjust the speed control valve.
6.
Tighten the locknut.
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Adjusting the Door Closing Speed
Service Manual
Description | 46
Adjusting the Door Latch Locking Speed 1.
Open the locknut (4) on the door latch control valve (2).
2.
Close the speed control valve (5) completely.
3.
Open the speed control valve 1.5 turns.
4.
Make sure that the motion of the door latch is smooth and without noise.
5.
If not, adjust the speed control valve.
6.
Tighten the locknut.
3.3.6 Adjusting the Door Lock WARNING Risk of Crushing Be very careful if the door remains fastened to the seal. When the door is detached from the seal it will fall down and may cause injury.
WARNING PINCH INJURY There is a risk of pinch injury when working close to the door latch. The door is locked by a spring loaded door latch 20 seconds after it has been closed. If the locking fails, the process can not be started. The latch is opened by compressed air when it is safe to open the door.
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For the door lock to work properly, it shall be adjusted according to the picture below:
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Description | 47
0000003473
Figure 23: Door latch in door closed position Door latch overlap: 10 to 16 mm. Door latch clearance: 2 ± 0.5 mm. Door Plate Cylinder fastening nut Door lock cylinder, HX00 or HX01 (second door) Air connection Interlock switch S100 or S110 (second door) Latch gripper Latch cylinder screw Door latch
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A B 1 2 3 4 5 6 7 8
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0000007614
Figure 24: Door latch fastening 8 Door latch 9 Latch fastening nuts For instructions on checking and adjusting the door lock mechanism, see Chapter 4.4.1 “Door Mechanism Safety Checks” on page 157.
3.3.7 Replacing the Door Gasket WARNING SECURING THE DOOR When replacing the door gasket, turn off the power and disconnect the compressed air supply to ensure that the door cannot close or move when work is in progress.
WARNING RISK OF CRUSHING
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After the travel limitation block has been removed, step back when opening the door to avoid crush injury below the door.
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NOTE DO NOT LUBRICATE THE DOOR GASKET The door gasket has a lifelong coating that provides low friction between the door and the rim of the chamber. The gasket should not be lubricated, as this may harm the coating. It is recommended to use gloves when handling the gasket, as the coating can be difficult to wash off.
A rubber block on the piston shortens the cylinder stroke and stops the door so the top of the door is flush with the chamber floor, thus covering the lower part of the gasket. When removing the rubber block the door is opened below the normal stopping point and the door gasket groove can be accessed.
1 Door stop block The door shall be in the closed position. 1.
Open the front panels that cover the door cassette.
2.
Locate the door cylinder and remove the door stop from the piston. Replace the door stop with a new one when reassembling the door.
3.
Open the door. ð The door now opens fully so the gasket groove can be accessed
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Accessing the Gasket Groove
Service Manual
Gasket Removal Procedure
Description | 50
Make sure the door is fully open so the complete gasket groove is accessible, see “Accessing the Gasket Groove” on page 49. 1.
Carefully remove the gasket from the groove. Use a plastic or teflon coated stick to loosen the gasket from the groove and pull it out with your hands.
2.
Remove the helical spring from the groove and verify that it is clean and undamaged.
3.
Carefully clean the gasket groove with isopropyl alcohol, an abrasive nylon and wipe it dry with a soft cloth.
Gasket Installation Procedure
0000005088
1.
Verify that the groove (position 1) is clean and undamaged.
2.
Place the helical spring at the bottom of the groove.
3.
Press the gasket joint into the middle of the upper horizontal part of the groove.
4.
Secure the gasket in the middle of the straight parts (example position 2) on all four sides of the groove so that its excess length is equally distributed between the fixing points.
5.
Press the gasket in between the previous fixing points, dividing the sections into smaller and smaller parts so that the entire excess length is equally distributed around the groove.
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Figure 26: Door gasket
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Description | 51
6.
Work some of the surplus towards the corners so that the gasket can properly fill the width of the groove at the corners.
7.
With the backside of a smooth and clean screwdriver handle, drag along the gasket to make sure that it is properly inserted to the groove.
3.3.8 Prolonging the Gasket's Service Life Getinge's door gasket is made of a special silicone material, and has a lifelong coating that provides low friction towards the door. The gasket should not be lubricated as this may harm the coating. When the door is closed the gasket is pressed against the door by compressed air or steam. When the door opens the gasket is retracted by vacuum. To prevent the gasket from blocking the air connection a helical spring is placed in the groove behind the gasket. To prolong the service life of the gasket, follow the advices below. There are several negative factors that are of critical significance to the useful life of the door gasket. By avoiding these as much as possible, the useful life of the gasket can be prolonged considerably. Advice for Prolonged Gasket Service Life
Keep the gasket groove clean.
Avoid leaving the sterilizer in standby mode over night or when out of use for longer periods. Constant heat from the chamber jacket might shorten the gasket's service life up to 60%.
Perform a full blowdown and empty the steam generator at prescribed intervals. The amount of minerals and impurities in the feedwater increase over time; at high concentrations, substances may follow the steam and get deposited on the gasket.
If the sterilizer is connected to the central steam, the steam quality and chemicals added to the feedwater affects the gasket's service life. High content of Hydrazine or Carbon Dioxide are examples of factors that shortens the gasket's service life.
3.4 Water Supply Under normal conditions, the sterilizer is designed for incoming cooling water within the temperature range 4-35°C, and with a pressure range of 3-6 bar. There are two exceptions to be considered:
If the sterilizer is fitted with a remote vacuum system, or if a leak test is performed, the water temperature must not exceed 30°C.
If the machine is a formaldehyde sterilizer or if C14 end vacuum (40 mBar) is required when running a process, the water temperature must not exceed 20°C.
For specific information, see the Technical Data Sheet.
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General Information
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Description | 52
Steam Generator Sterilizers: Dual connection with Feedwater Tank B16
0000001443
Figure 27: Water connection arrangement Feedwater tank B16 Water inlet to feedwater tank Water inlet for coolant water, via strainer F10 Connection to jacket cooling (not used, unless header tank is mounted) Connection to vacuum unit, for cooling and sealant water Connection to cooling of blowdown tube, via valve FV23/1 Connection to feedwater pump P16 Overflow connection to drain tank B17
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1 2 3 4 5 6 7 8
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Description | 53
3.4.1 Tank B16
0000001555
Figure 28: Tank B16 1 2 3 4 5 6
Water Outlet Overflow to drain Floater Float valve LV16 Water inlet Return from feedwater pump (when B16 is used as feedwater tank)
In the connection to the float valve LV16, there is a plastic strainer to prevent particles from entering the valve. When the water level in the feedwater tank B16 drops, the float valve LV16 opens and refills water to the maximum water level. The maximum water level can be adjusted by moving the floater on the arm.
Cleaning and Inspecting Tank B16
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The tank must be regularly cleaned to prevent the growth of algae and bacteria. Observe local restrictions and the recommendations of hygiene, and make sure to use personal protective equipment (PPE) when needed. Note that bacteria and algae that find their way into the steam generator may form pyrogens that end up on and in the sterile goods.
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0000001555
Figure 29: Float valve LV16 in tank B16 1 2 3 4 5 6
Water outlet Overflow outlet Float cylinder Float valve LV16 Water inlet Return from feedwater pump (optional - only used for Option treated water)
1.
Remove the tank's lid.
2.
Check that the water is clear and without no impurities.
3.
Check that the water level in the feed water tank is about 12 mm below the overflow outlet. To adjust the water level, rotate the float cylinder up or down the threaded rod.
4.
Turn off the inlet water.
5.
Remove the connection for inlet water.
6.
Use a pair of pliers to pull out the plastic strainer located in the connection to the float valve LV16.
7.
Clean the strainer by flushing it with water.
8.
Put back the strainer.
9.
Put back the connection for inlet water.
10. Turn on the inlet water. 11. Clean the tank using an abrasive nylon brush. 12. Rinse the tank by engaging the float valve LV16. Keep the float valve open until all residuals have been rinsed through the tanks overflow pipe.
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13. Refit the tank's lid.
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Description | 55
3.5 Steam Equipment 3.5.1 Steam Generator The steam generator has a volume of 50 liters. It is controlled by the sterilizer's control system, which keeps the operating pressure and water level within pre-set limits.
General Considerations
Steam to steam generators and compact boilers are sensitive to the feedwater treatment quality. Priming of foaming might emerge due to a high level of Total dissolved solids (TDS), incorrect feedwater treatment or a faulty blowdown system, and this causes droplets in the steam. To avoid wet steam, it is important to perform regular maintenance and cleaning of the sterilizer, and to ensure that the feedwater quality is adequate. See the Installation Manual sections Water Requirements (especially section for “Water Treatment and Control”) and Steam Requirements for further information concerning feedwater/steam quality and boiler operation.
The switch starts the feedwater 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.
0000001254
Figure 30: Normal level switch 1 Signal cable 2 Level Switch LS04 3 O-ring The level switch's fork is brought to its resonance frequency by a piezoelectric drive. When the water level drops below the fork the frequency changes, which sets the digital input signal to 0. The switch has status LED lights which are visible through a window in the housing:
Green light indicates that the switch has power and is working.
Orange light indicates that the water level is below the switch.
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The Normal Level Switch LS04
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Description | 56
The Low Level Switch LS05 The low level switch prevents the generator from boiling dry when the water level is below the top of the heating elements. When the water sinks below the switch's limit, the heating elements are turned off. If the water level has not risen above the low level within 50 seconds, the Steam generator failure alarm is triggered.
0000001588
Figure 31: Low level switch
The steam generator can have five or six elements. When only five elements are used, one element is replaced with a cover plate.
0000001633
Figure 32: Heating element 1 2 3 4 5 6
Cover Triangular cap Ground connection Phase connections Flange Gasket
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Electrical Heating Elements
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Filling the Steam Generator 1.
On the touchscreen, go to the Steam Generator page. “System è Service è Steam Generator”
2.
Tap Water Filling . ð The steam generator is now filled to its normal level.
3.5.2 High Temperature Protection The high temperature protection is a safety device that turns off the heating elements within the range 160 to 171 °C (320-340 °F). The high temperature protection consists of a temperature sensor that is inserted into a immersion pipe in the tube in the steam generator's front, and a switch with a reset button placed in a junction box on one of the stand legs. As the sensor is not in direct contact with the steam, the high temperature protection has some inertia.
0000003508
Figure 33: High temperature protection 1 Temperature Limiter TS21 2 Temperature sensor To reset the high temp protection, see Chapter “Resetting the High Temp Protection” on page 57.
Resetting the High Temp Protection
1.
Open the cover to the temperature limiter's junction box.
2.
Press the reset button on the switch.
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Before resetting the steam generator high temperature protection circuit, the sensor must be in the temperature range from 20 to 171 °C (68 to 340 °F)
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NOTE If there is a leak in the sensor tube, the switch will not reset.
3.5.3 Pressure Transmitter The steam generator has a pressure transmitter that monitors the pressure in the generator and sends data to the control system. 1 Pressure transmitter PE06 2 Pressure hose to the steam generator
0000003509
Figure 34: Pressure transmitter
3.5.4 Feedwater Pump
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The feedwater pump supplies the steam generator with water. It is a selfpriming centrifugal pump powered by a three phase electric motor.
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0000001897
Figure 35: Feedwater pump. 1 2 3 4 5 6 7 8 9
Venting connection (return to the feedwater tank) Water outlet Ball valve H16/1 Piston valve FV16/1 Pump house P16 Water inlet Electric motor Restriction X16/2 Restriction X16/1
Removing the Feedwater Pump WARNING HEAVY COMPONENT
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Beware of heavy component. Use appropriate equipment when handling the component to avoid injury.
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0000006214
Figure 36: Removing feedwater pump 1 2 3 4 5
Hose to feedwater tank Hose to header tank Pipe connection Pipe connection Screws
1. Empty the feed water tank: a
Temporarily fixate the tank's floating valve into the closed position.
b
Activate the digital output Feed water pump and valve (DO28) until the tank is empty, or disconnect one of the hoses from the tank and direct the water to the drain.
2.
On the feed water pump, disconnect the water inlet, return and outlet.
3.
On the blow down assembly, disconnect the connections to the steam generator, cooling water and to the drain tank.
4.
Unscrew the two bolts at the feed water pump stand and pull the feed water pump and blow down assembly outward.
Loosening a Stuck Feedwater Pump
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The pump's impeller or the shaft of the feedwater pump might seize if the pump has been out of use for a longer period.
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0000006314
Figure 37: Feedwater pump, fan impeller 1 2 3 4
Screw Washer Fan hood Fan impeller
1.
Remove the fan hood on the pump.
2.
Pry off the fan impeller using symmetrically applied levers, for example, strong screwdrivers. ð The motor's shaft is now accessible.
3.
Wrap the shaft end with protective material like folded sheet metal and try to twist it using a pipe wrench or adjustable pliers. ð If the rotor loosens so the shaft can be twisted, reassemble the fan impeller and hood. If it remains stuck, continue with the following step.
4.
Loosen the screws holding the pump casing together about one turn, then try to twist the shaft again. ð If the rotor loosens so that the shaft can be twisted, reassemble the fan impeller and the fan hood. If it remains stuck, continue with the following step.
5.
Tap the loosened half of the pump casing carefully and twist the shaft again.
6.
Tighten the screws to the pump casing and verify that the shaft still can rotate. Reassemble the fan impeller and fan hood.
7.
Turn on the main switch and verify that the motor is working normally by manually operating the contactor.
3.5.5 Blowdown Equipment
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During a blowdown, the valve to the drain at the bottom of the steam generator opens for a few seconds. The steam pressure then pushes the bottom water out together with impurities on the bottom of the generator.
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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.
0000001900
Figure 38: Blow down equipment 1 2 3 4 5 6 7 8
Blowdown mixer Connection for cooling water Connection to the steam generator's drain Drain tube to drain tank B17 Cooling water valve FV23/1 Manual drain valve H23/2 for the steam generator Speed control valve XR23/2 Blowdown valve FV23/2
The Blowdown Sequence 1
The cooling water valve opens.
2
The blowdown valve opens from closed to fully open and then closes quickly (three seconds in total).
3
The cooling water valve closes slowly.
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If a full blowdown is performed, the procedure will be repeated until the pressure in the boiler is stabilized under 1.2 bar(a).
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Description | 63
Resetting the Blowdown Equipment
0000006660
Figure 39: Setting blowdown equipment 1 Speed control valve XR23/1 2 Speed control valve XR23/2 3 Blowdown valve FV23/2 1.
On the speed control valve XR23/1, close the adjustable restriction completely and then open it 2 revolutions.
2.
On the speed control valve XR23/2, close the adjustable restriction completely and then open it 0.75 revolutions.
3.
Run the blowdown sequence and check that the valve actuator on FV23/2 moves from closed to fully open and then closes quickly. At the same time check that the drainage trough does not spill over.
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If required finetune the settings on XR23/1 and XR23/2 so the required functionality is achieved
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Description | 64
3.5.6 Steam Piping Steam Piping Bottom for Steam Generator Sterilizers
0000001704
Figure 40: Steam piping, bottom of sterilizer 1 2 3 4
The piping supplies the chamber and the jacket with steam and air.
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Steam Piping Top for Steam Generator Sterilizers
Steam from steam generator Supply to steam tubing on top of the sterilizer Ball valve H16/4 Condensate Drain
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Description | 65
0000001700
Figure 41: Steam piping on the top of the sterilizer 1 2 3 4 5 6 7 8 9
Sterile air valve FV06 Steam to chamber valve FV07 Steam strainer F07 and steam sample port Branch for steam sample cooler (optional) Steam to jacket valve FV09 Steam supply Media to jacket connection Media to chamber connection Air inlet
3.5.7 Steam Trap Steam traps stops steam from running through the piping but lets water and cool air pass through.
0000000782
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Figure 42: Steam trap, open and closed.
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Description | 66
The operating element is a capsule containing a liquid with a lower boiling point than water. When the steam trap is cool the valve is open so air and small amounts of condensate can escape through the steam trap. As more hot condensate passes through the trap, heat is transferred to the liquid in the capsule, which boils before steam reaches the trap as it has a lower boiling point. The vapor pressure within the capsule causes it to expand and the valve closes. Heat loss from the steam trap body then cools it down and the valve opens again when the capsule contracts as the vapours of the fill liquid condensate.
3.5.8 Steam Trap Maintenance The steam traps may occasionally get stuck in one position, open or closed. If a steam trap is stuck in its open position, it will be indicated by steam leaking out from the drain. If a steam trap is stuck in its closed position, it may be indicated by problems with wet load.
Checking the Steam Trap Check that the sterilizer is in standby mode.
2.
Check the function of the steam trap by observing the outlet of the steam trap. The steam trap should open, release condensate and then close again.
3.
If the steam trap is stuck in its open position, tap it lightly on the outside to disengage it and to enforce closing.
4.
If the steam trap still not opens and closes as expected: Turn off the machine, let it cool down and disassemble the steam trap for cleaning or replacing its internal parts, see “Renovating a Steam Trap” on page 66.
Before disassembling a steam trap, make sure that the steam trap and its connected pipes are depressurized and cool. If disassembling the steam trap in place, be aware that surrounding pipes and equipment may be hot.
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Renovating a Steam Trap
1.
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Description | 67
1 2 3 4 5 6 7 8 9
0000008008
Figure 43: Steam trap parts Cap O-ring Spring Capsule Spacer plate Seat Strainer Seat gasket Housing
1.
Unscrew the cap and lift it up carefully as the assembly is spring loaded.
2.
Disassemble the parts, note the direction of the spring and spacer plate.
3.
Clean the strainer.
4.
Check that the capsule and seat. Replace if damaged.
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1 2 3 4 5 6 7 8 9
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Description | 68
5.
Reassemble the steam trap:
Use a new seat gasket. When assembling the seat, use a small amount of Molykote 1000 and tighten to 35 –40 N·m.
When reassembling the spacer plate, make sure it is placed centrally over the seat and with the right side up.
When reassembling the capsule and spring, make sure the spring is placed with the narrow side downward and in contact with the capsule.
6.
Use a new O-ring for the cap and tighten the cap to 50 –60 N·m
When reassembled, start the machine and check the function again, see “Checking the Steam Trap” on page 66.
3.6 Chamber and Jacket 3.6.1 Chamber Ports
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The chamber ports are located on the service side of the sterilizer. This section illustrates the design and usage of chamber ports.
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Description | 69
Chamber port design STD1
0000006693
Figure 44: Chamber ports usage, design STD1 Safety valve Pressure Transmitter PE05 or pressure switch Not used test leak (sterilizers with Air detector) Validation
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1 2 3 4 5
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Description | 70
3.6.2 Jacket Jacket Top, without Jacket Cooling
0000002909
Figure 45: Jacket top piping without jacket cooling 1 2 3 4
Connections and components for draining the jacket from heating steam are located at the bottom of the jacket.
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Jacket Bottom without Jacket Cooling
Steam connection Safety valve connection Pressure gauge connector Jacket temperature sensor
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Description | 71
0000002914
Figure 46: Jacket bottom piping for sterilizers without jacket cooling 1 2 3 4 5
Jacket connections Jacket vacuum valve FV11 Check valve R11 Temperature sensor TE07 Connection to vacuum unit
When heating the jacket, steam enters at the jacket top and drains through the connection to the vacuum unit (5).
3.7 Drain The drain module connects the chamber with the vacuum pump for draining, flow control and pressure regulation.
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Drain Module Overview – GSS67H, GSS67F
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Description | 72
1
2
3
4
5 6 7 11 10
9
8 0000007977
Figure 47: Drain module overview 1 2 3 4 5 6 7 8 9 10 11
Air detector (option) Positioner (Control Unit) with air valve PV300 Proportional valve FCV12 Connection to chamber bottom Connection to chamber pressure gauges and supervisor pressure sensor PE29 (for sterilizers without supervisor: Pressure switch PS01) Connection for chamber temperature sensor TE00 Condensate bleeder valve FV13 Bleeder check valve FCV12AD Connection for jacket vacuum Connection for gasket groove vacuum Connection to vacuum system
The condensate drain valve FV13 (7) is used for draining condensate and regulating pressure during the pretreatment and the sterilization phase. The proportional valve FCV12 (3) is used for dynamically controlling the pressure rate of change during evacuation and post processing. This is both for keeping the pressure rate of change within the limits specified by the program and for avoiding temperature chocks that might damage the condenser W08. NOTE
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In case of a power failure, FCV12 must be closed rapidly to prevent backflow. As the actuator control unit cannot operate without power, PV300 will be triggered by the loss of power and close FCV12 pneumatically.
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Description | 73
3.7.1 Removing the Drain Module WARNING HEAVY COMPONENT Beware of heavy component. Use appropriate equipment when handling the component to avoid injury.
0000005870
Figure 48: Drain module, standard air detector 1 Air detector TE03 2 Connection to vacuum pump 3 Clamp 1.
Disconnect the bracket of the air detector pipe, if fitted.
2.
Disconnect the connections to the jacket, the gasket groove and the vacuum pump.
3.
Loosen the clamp and carefully remove the drain valve.
3.7.2 Calibrating the Positioner The positioner adjusts the opening of the drain valve FCV12 according to the values from the analog output Chamber Drain (AO00). It is equipped with LED lights that indicates the status of the valve opening, errors and need of calibration.
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If FCV12 is not working properly, the positioner might need a calibiration by a procedure where the positioner detects and records the valves end positions.
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Description | 74
OPEN ERROR CLOSED POWER
0000008017
Figure 49: LED Indicators OPEN Yellow light, steady light together with the POWER LED when the valve is in open position. Flashes when the valve is opening. ERROR Red light, steady light if the valve is out of calibration. Flashes if other error occurs. CLOSED Orange light, steady light together with the POWER LED when the valve is in closed position. Flashes when the valve is closing. POWER Yellow light, flashes slowly if the valve is out of calibration. Otherwise steady light if the unit is powered.
Troubleshooting
The need of calibration is indicated by one or several of the following conditions:
Slow or aborted processes.
Pressure decrease not within specified limits.
The sterilizer does not reach the lower vacuum limits. Error message on the positioner: – POWER LED flashes slowly yellow
The positioner shall also be calibrated when replacing FCV12 or the positioner itself.
Calibration Procedure The jumper X420.a delivered with the sterilizer is needed for the calibration 1.
Make sure that the sterilizer is in standby mode and without active alarms.
2.
Below the chamber, locate the terminal X420a on the junction box A 100.
3.
Put the calibration jumper X420.a on the X420a terminal and remove it again directly. It must not be placed on the terminal for more then 3 seconds. ð The positioner will now start its calibration procedure, which lasts for about 5 minutes.
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When the valve stops working and the power indicator LED lights steady yellow, the calibration procedure is finished.
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Description | 75
3.7.3 Replacing the Drain Bleeder Check Valve FCV12AD is a combined restrictor and check valve placed in the drain module, after the drain bleeder valve FV13. For removing FCV12AD, use a long M6 threaded bolt or the drain valve extractor tool (no. 890610008)
1
2
3
4
5 0000007978
Figure 50: Accessing FCV12AD 1 2 3 4 5
Connection to vacuum system Connection for gasket groove vacuum Connection for jacket vacuum Clamp Check valve FCV12AD
1.
Remove the connections on the pipe elbow between the drain module and the hose to the vacuum system (1), (2), (3).
2.
Loosen the clamp (4) and remove the pipe elbow. ð FCV12AD is now visible inside the drain module.
3.
With a 5mm hexagonal key, unscrew and remove the cover.
4.
Use the M6 threaded drain valve extractor to remove the check valve and restrictor assembly FCV12AD.
5.
Replace the check valve assembly. Lubricate the O-ring with Molykote 111 Compound before mounting the check valve into the drain module.
6.
Put back the cover plate and tighten it.
7.
Reassemble the pipe elbow and its connections. When tightening the connection between the pipe elbow and the hose to the vacuum system, make sure to hold the hose still and turn the nut on the elbow. Put back the clamp.
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8.
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Description | 76
3.8 Vacuum Unit The sterilizer is equipped with a vacuum unit positioned either at the bottom of the sterilizer stand or at a separate stand at a remote location. To remove a vacuum unit from a sterilizer, see the . During operation the pump provides vacuum for the chamber's drain and other functions that require vacuum. Parts of the cooling system is also integrated with the vacuum pump unit:
A condenser that reduces the volumes for the vacuum pump to handle by condensing the steam before entering the pump.
A heat exchanger that cools steam and condensate before going to drain.
For sterilizers with circulating cooling: An additional cooling loop and heat exchanger for the cooling water.
The vacuum unit consists of an electric motor, a two-stage liquid ring vacuum pump, a separator, a casing, and a condenser. 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. The vacuum unit has an integrated sealant water tank, as the pump requires water as sealant between the impeller chambers. The pump is continuously supplied with new water from the tank as a portion of the existing water escapes through the discharge. The sealant water also cools the pump.
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The discharged mixture of sealant water and condensate is separated from gases by a separator and returned to the sealant water tank through a heat exchanger. To keep the sealant water fresh, the tank is periodically overfilled, causing a portion of the existing sealant water to overflow down the drain.
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Description | 77
1
2
3
6
4
5 0000007967
Figure 51: Vacuum pump assembly 1 2 3 4 5 6
Heat exchanger W017 Casing Motor, with the pump attached to the motor shaft. Sealant water level switch LS19 Separator with integrated sealant water tank Condenser W08
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Sterilizers with circulating cooling have an additional heat exchanger placed below the condenser, see the
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Description | 78
Vacuum and Cooling Connections
1
2
3
4
5
6
7
10
9
8 0000007971
Figure 52: Connections on vacuum and cooling system 1 2 3 4 5 6 7 8 9 10
Compressed air inlet, for cavitation protection Cooling Water outlet Inlet steam and condensate from steam supply Condensate outlet, to drain Cooling water inlet Condenser cooling water outlet Steam and condensate inlet, from chamber drain and vacuum connection. Overflow / pump discharge, to drain Cooling water inlet Sealant water inlet
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Sterilizers with circulating cooling have an additional heat exchanger placed below the condenser, see the
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Description | 79
Vacuum and Cooling Piping
2
1
3
4 5
6
7
0000007975
Figure 53: Vacuum and cooling piping on a standard sterilizer 1 2 3 4 5 6 7
Min cooling valve FV17 (always on) Medium Cooling valve FV18 Maximum Cooling valve FV19 Cooling temperature sensor TE04 Check valve R07 Sealant water valve FV10 Steam trap A07
Sterilizers with circulating cooling have a different placement of the FV18 valve an additional ball valve for turning the circulation on or off, see the .
The piping of the vacuum system contains the following restrictors.
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Restrictors
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Description | 80
0000006791
Figure 54: Vacuum system restrictors 1 2 3 4
X10 X19 X17 X18
For information about restrictor sizes, see the P&I diagram.
3.8.1 Cleaning of Heat Exchangers Heat exchangers are sensitive for limescale (lime deposits) and need regular cleaning. The cleaning interval depends on the water quality and is thereby specific for each sterilizer. The most important aspect of the water quality is the hardness. For water hardness below 4 dH an interval of 2 years might be suitable, harder water might need shorter intervals. For more information on water quality, see Chapter 5.1 “Water Quality” on page 169.
1.
Remove the heat exchanger.
2.
Read the instructions for the descaler and prepare the cleaning solution.
3.
Fill the heat exchanger with the diluted cleaning solution and let it dissolve the limescale according to the descaler instructions.
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The recommended cleaning agent is a phosphoric acid based descaler, like Getinge Clean Neutralizer Plus.
Service Manual
Description | 81
4.
5.
After cleaning the heat exchanger, perform a leak test to verify that there is no external or internal leakage between the two heat exchanger circuits:
Put the heat exchanger on a flat surface
Fill one circuit with water
Plug one end of the circuit
Connect the unplugged connection to water under pressure at 3-6 Bar
Verify that there are no external leaks
Verify that there are no internal leaks, which will appear as water leaking from the empty circuit’s connections
Repeat the procedure for the other circuit
Use new gaskets when reassembling the heat exchanger.
3.9 Air Filter The sterilizer is equipped with one of the filter types described below
Atmospheric Air Filter
This is a sterile filter that filters the atmosphere air when it enters the chamber during pressure equalization. Prolonged time for pressure equalization might indicate that the filter is clogged and need to be replaced at a shorter interval then recommended by the maintenance overview. The filter and its housing are one disposable unit. The replacement filter is sterilized and packed in welded bags. The filter is not to be unpacked until installation.
0000000675
Figure 55: Atmospheric air filter 1 Nipple 2 O-ring 3 Filter
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Replacing the Atmospheric Air Filter
Service Manual
3.10
Description | 82
1.
Remove the used filter and dispose it in accordance with local and national regulations.
2.
Verify that the O-ring inside the nipple is undamaged. Replace the O-ring if necessary.
3.
Unpack the replacement filter and push its conical tube into the nipple.
4.
Verify that the filter is tightly fitted to the nipple and that the piping for the sterile air is intact.
Electrical Power Cabinet The electrical cabinet contains terminals, contactors and other high voltage components. WARNING ELECTRIC SHOCK HAZARD Turn off the mains power to the sterilizer, and lock out and tag out before starting to work with the electrical equipment.
The table below lists recommended tightening torques for electrical power connections for sterilizers with integrated electrical steam generator. The designations refers to the Electrical Diagram. Note that the actual configuration of electrical components depends on the sterilizer's options. See the electrical diagram and the marking of components for determining which parts of the table that applies.
Designation
Connection
Q001
Main Switch
X101
Main Power Terminal
X102
Torque (N m)
Type Mitsubishi Electrics NV250-CV: 12 N·m(8.85 lbf·ft)
Type Schneider Electric INSJ400-250 31 N·m (22.9 lbf·ft)
Type Schneider Electric V5: 22.6 N·m (16.7 lbf·ft)
In: 19 N·m (14 lbf·ft) Out: 2.7 N·m (2 lbf·ft)
X103 F100
Circuit Breaker or fuse holder 2.8 N·m (2.1 lbf·ft)
F110 F111 F112 F120
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Tightening torques for Sterilizers with Electric Steam Generator
Service Manual
Description | 83
Designation
Connection
Q113
Heating elements contactors
Torque (N m)
Type Schneider Electric LC1-D40ABD: 5 N·m (3.7 lbf·ft)
Type Schneider Electric LC1-D25BL: 2.5 N·m (1.8 lbf·ft)
Type Schneider Electric LC1-D18BL: 1.7 N·m (1.2 lbf·ft)
Type Schneider Electric LC1-D09BL:1.7 N·m (1.2 lbf·ft)
Large size yokes (2 AWG / 35 mm²): 4.5 N·m (3.3 lbf·ft)
Medium size yokes (6 AWG / 16 mm²): 2.6 N·m (1.9 lbf·ft)
Small size yokes (8 AWG / 10 mm²): 1.2 N·m (0.9 lbf·ft)
Q114 Q115
Clamping yokes on bus bars for ground and neutral connections
X0
Ground terminal block
6 N·m (4.4 lbf·ft)
Main power cable glands
13 N·m (9.6 lbf·ft)
WARNING ELECTRIC SHOCK HAZARD Turn off the mains power to the sterilizer, and lock out and tag out before starting to work with the electrical equipment.
3.11
Sensors This section describes the generic usage of sensors on GSS67H, GSS67F and GSS67N sterilizers, including options. For sterilizer's with customized options, the sensor's name, usage or connections may be different. See the electrical diagram delivered with the sterilizer for machine specific information.
3.11.1 Chamber Pressure Sensor PE05
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The chamber pressure sensor monitors the pressure in the chamber for the controller.
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Description | 84
ATTENTION Pressure sensor precautions Pressure sensors are sensitive and shall be handled carefully.
–
When dismounting and mounting a chamber pressure sensor: Use handcraft only
–
Mount it with a new O-ring
–
Do not use thread tape or other sealant material when mounting the sensor.
Protect the sensor from mechanical chocks.
Put a protective cap over the diaphragm when having the sensor dismounted.
Do not pull, bend or twist the sensor's cables incautiously.
Keep the sensor clean.
0000006800
Figure 56: Chamber pressure sensor PE05
Designation
Value
Sensor name
Chamber Pressure
Sensor tag
PE05
Signal index
AI 00
I/O Module
K52
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For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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Description | 85
3.11.2 Boiler Pressure PE06 The boiler pressure sensor monitors the pressure in the steam generator. 1 Pressure transmitter PE06 2 Pressure hose to the steam generator
0000003509
Figure 57: Pressure transmitter
Designation
Value
Sensor name
Boiler Pressure
Sensor tag
PE06
Signal index
AI 01
I/O Module
K52
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
3.11.3 Supervisor Chamber Pressure Sensor PE29 This sensor is only present on sterilizers equipped with supervisor.
0000006803
Figure 58: Supervisor chamber pressure sensor PE29
Designation
Value
Sensor name
S Chamber pressure
Sensor tag
PE29
Signal index
AI 22
I/O Module
K93
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For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Service Manual
Description | 86
3.11.4 Chamber Temperature Sensor TE00 The chamber temperature sensor TE00 monitors the chamber temperature for the controller.
0000006801
Figure 59: Chamber temp sensor TE00
Designation
Value
Sensor name
Chamber temperature
Sensor tag
TE00
Signal index
AI 02
I/O Module
K53
Sensor tip assembly depth: 95 mm below the chamber floor. If the sterilizer is equipped with supervisor, a dual sensor probe is used for TE00 and TE24.
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For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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Description | 87
3.11.5 Jacket Temperature Sensor TE01
0000006751
Figure 60: Jacket temperature sensor TE01
Designation Sensor name
Value Jacket temperature
Sensor tag
TE01
Signal index
AI 03
I/O Module
K53
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For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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Description | 88
3.11.6 Condenser Temperature Sensor TE04
0000006752
Figure 61: Condenser temperature sensor TE04
Designation
Value
Sensor name
Condenser temperature
Sensor tag
TE04
Signal index
AI 04
I/O Module
K53
Sensor tip assembly depth: 170-180 mm from the flange.
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For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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Description | 89
3.11.7 Drain Jacket Temperature Sensor TE07
0000006754
Figure 62: Jacket drain temperature sensor TE07
Designation
Value
Sensor name
Drain jacket temperature
Sensor tag
TE07
Signal index
AI 05
I/O Module
K53
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
3.11.8 Supervisor Chamber Temperature Sensor TE24
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This sensor is only present on sterilizers equipped with supervisor.
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Description | 90
0000006801
Figure 63: Supervisor chamber temperature sensor TE24
Designation
Value
Sensor name
S Chamber temperature
Sensor tag
TE24
Signal index
AI 20
I/O Module
K94
Sensor tip assembly depth: 95 mm below the chamber floor. A probe with two independent sensors are used for the sensors TE00 and TE24. For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
3.11.9 Troubleshooting Sensors and AI Signals Fault in sensors and signals are indicated by alarms that reveals which signal that is out of function. This section describes how to determine wether th fault it is in the sensor, the wiring or the I/O module.
Identifying the Faulty Part Open the Analog Inputs view. “Menu è System è Service è Diagnostics è Analog Inputs” ð The value for the faulty AI signal is displayed as ********
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1.
Service Manual
Description | 91
2.
Check the wiring for damages and for loose contacts at the sensor and the I/O module. For information about sensors and I/O modules, see Chapter 3.11 “Sensors” on page 83. ð If the wires are damaged or the reading changes when reconnecting, the fault is probably in the wiring. Continue with checking or replacing the wires or contacts.
3.
3.12
Disconnect the sensor and connect the wiring to a sensor of the same type.
If the reading for the signal changes from ****** to an actual value, continue with replacing the sensor. If a chamber pressure sensor shall be replaced after stop in an LTSF procedure, see the .
If the reading does not change from ****** when connecting the replacement sensor, continue with replacing the I/O module, see the .
G1 Control System This section describes the hardware and software for machines with Getinge's G1 control system.
See also the Electrical Diagram for detailed installation information.
3.12.1 Operator Panel The operator panel is a 10.1" WSVGA TFT Power panel with a full-format touchscreen. The surface of the touchscreen is used for all button-press actions and data entry. The pixel resolution is 1024x600. The whole panel measures 192x290x44mm (7.6x11.4x1.7in), (HxWxD)
Integrated Computer
The panels are equipped with integrated processors, memory and other computing hardware. For double door sterilizers, the controller software is executed on the main panel's computer.
3.12.2 Power and Bus Modules BR9300 The bus receiver BR9300 is used to connect the X20 System to the X2X Link. The module is equipped with a feed for the X2X Link as well as the internal I/ O supply.
X2X Link bus receiver
Supply for X2X Link and internal I/O supply
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The left and right locking plates are included in the delivery (for info on installation see chapter 6 "Mechanical design", page 1120).
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Description | 92
Electrical isolation of feed and X2X Link supply
Redundancy of X2X Link supply possible by operating multiple supply modules simultaneously
Operation only on the slot to the far left
Status LEDs
0000003946
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e
Double red flash
Indicates one of the following conditions:
Figure 64: BR9300
X2X Link power supply is overloaded
I/O supply too low
Input voltage for X2X Link supply too low
e+r
Steady red/ single green flash
Invalid firmware
X
Off
No communication at the X2X Link
X
Steady orange
X2X Link communication in progress
I
Off
X2X Link supply in the acceptable range
I
Steady red
X2X Link power supply is overloaded Solution: Use an additional feed module PS3300
Pin Assignments
See the electrical diagram for pin assignment.
PS2100
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The PS2100 supply module is used for internal I/O supply.
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Description | 93
24 VDC supply module for internal I/O supply
Status LEDs
0000003952
Figure 65: PS2100
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e
Double red flash
Indicates one of the following conditions:
e+r
Pin Assignments
Steady red/single green flash
I/O supply too low
X2X bus supply too low
Invalid firmware
See the electrical diagram for pin assignments.
PS9502 The supply module PS9502 is used together with an X20 Compact or Fieldbus CPU. It is equipped with a feed for the Compact or Fieldbus CPU, the X2X Link and the internal I/O supply.
Supply for the Compact or Fieldbus CPU, X2X Link, and internal I/O supply
Low-cost supply module for small X20 Systems
No electrical isolation of feed and CPU / X2X Link supply
Expansion or redundancy of CPU / X2X Link supply not possible by operating multiple supply modules simultaneously
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The module is intended as a low-cost supply module for small X20 Systems. Potential groups are able to be formed. An expansion or redundancy of the X2X Link with the PS3300 or PS3310 supply module is not possible. Expansion of the X20 System with a bus transmitter is not permitted either.
Service Manual
Description | 94
RS232 can be configured as an online interface
CAN bus
Status LEDs
0000003951
Figure 66: PS9502
Pin Assignments
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e
Double red flash
Indicates one of the following conditions:
The CPU / X2X Link power supply is overloaded
I/O supply too low
Input voltage for CPU / X2X Link too low
e+r
Steady red/single green flash
Invalid firmware
S
Off
The CPU does not send any data via the RS232 interface.
S
Steady yellow
The CPU sends data via the RS232 interface.
C
Off
The CPU does not send data via the CAN bus interface.
C
Steady yellow
The CPU sends data via the CAN bus interface.
T
Off
The terminating resistor integrated in the BB27 or BB37 bus module is turned off.
T
Steady yellow
The terminating resistor integrated in the BB27 or BB37 bus module is turned on.
See the electrical diagram for pin assignments.
3.12.3 I/O Modules
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This section contain generic descriptions of the I/O modules in the G1 system. For information about the I/O configuration for a specific sterilizer, see the electrical diagram.
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Description | 95
Each I/O module consists of three modules fitted together.
Overview
0000003974
Figure 67: I/O Module
Module
Description
DI9371
12 digital input channels with 1-wire connections, see Chapter “DI9371” on page 96.
AI2437
2 analog input channels with 16-bit digital converter, see Chapter “AI2437” on page 96.
AO2622
2 analog output channels with 12 bit resolution. see Chapter “ AO2622” on page 97
AT2311
2 analog input channels for PT100 sensors,see Chapter “AT2311” on page 98
DO4649
4 digital output channels, with relay outputs, see Chapter “DO4649” on page 99.
DO9322
12 digital output channels, with 1-wire connections, see Chapter “DO9322” on page 100.
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1 Bus module, for power supply and communication within the system. 2 Electronic module for the specific type of I/O handling. The front of the electronic modules are equipped with LEDs that displays the status of the signals and the module itself. 3 Terminal block, for connecting cables from sensors, actuators and other equipment on the sterilizer. The terminal blocks are equipped with probe ports next to each cable connection.
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Description | 96
DI9371
12 digital inputs
Sink connection
1-wire connection
Software input filter can be configured for entire module
Status LEDs
0000003931
Figure 68: Status LEDs
Pin Assignments
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e+r
Steady red/single green flash
Invalid firmware
1-12
Steady green
Input status of the corresponding digital input
See the electrical diagram for pin assignments and usage of specific I/O modules.
AI2437 The AI2437 module is equipped with two inputs that have 16-bit digital converter resolution.
2 analog current measurement inputs
Electrically isolated analog channels
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Each current measurement input has its own sensor supply. The two channels with their respective sensor supplies are electrically isolated from each other. The user can select between the two measurement ranges 4 to 20 mA and 0 to 25 mA.
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Description | 97
Electrically isolated sensor supplies
16-bit digital converter resolution
Status LEDs
0000003934
LED
Light
Description
r (Operating status)
Off
Module supply not connected
r (Operating status)
Single green flash
Unlink mode
r (Operating status)
Blinking quickly green
Sync mode
r (Operating status)
Blinking slowly green
Preoperational mode
r (Operating status)
Steady green
Run mode
e (Module status)
Off
Module supply not connected or everything is OK
e (Module status)
Single red flash
A conversion error has occurred. When an error occurs, the LED of the faulty analog input channel begins to double flash and this status is output
e (Module status)
Steady red
Error or reset state
V (Sensor supply)
Off
Overload
V (Sensor supply)
Steady yellow
Sensor supply in normal operating range
1-2 (Analog input)
Off
Indicates one of the following conditions:
Figure 69: AI2437
Pin Assignments
Module supply not connected
Channel disabled
Open circuit
1-2 (Analog input)
Single green flash
Overflow or underflow of the input signal
1-2 (Analog input)
Double green flash
A conversion error has occurred. A single flash is output on the red "e" module status LED.
1-2 (Analog input)
Steady green
Analog/digital converter running, value OK
See the electrical diagram for pin assignments and usage of specific I/O modules.
AO2622 The AO2622 module is equipped with two outputs with 12 bit digital converter resolution. Using different connection terminal points you can select between the current and voltage signal.
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The AO2622 is designed for the X20 6-pin terminal blocks. If needed (e. g. for logistical reasons), the 12-pin terminal block can also be used.
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Description | 98
2 analog outputs
Both current and voltage signals are possible
12-bit digital converter resolution
Status LEDs
0000003938
Figure 70: AO2622
Pin Assignments
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e
Steady red
Error or reset state
e+r
Steady red/ single green flash
Invalid firmware
1-2
Off
Value = 0
1-2
Steady orange
Value ¹0
See the electrical diagram for pin assignments and usage of specific I/O modules.
AT2311 The AT2311 module is equipped with two inputs for PT100 4-line resistance temperature measurement.
2 inputs for resistance temperature measurement
PT100 sensor
Direct resistance measurement as well
4-line measurement
Filter time can be configured
0000003939
Figure 71: AT2311
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything is OK
e
Steady red
Error or reset state
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Status LEDS
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Description | 99
Pin Assignments
LED
Light
Description
e
Single red flash
Warning/error for an I/O channel. Overflow or underflow of the analog inputs.
e+r
Steady red/ single green flash
Invalid firmware
1-2
Off
The input is switched off
1-2
Blinking green
Overflow, underflow or broken connection
1-2
Steady green
The analog/digital converter is running, value is OK
See the electrical diagram for pin assignments and usage of specific I/O modules.
DO4649 The DO4649 module is equipped with four relay outputs.
4 digital outputs
Relay module for 230 VAC / 30 VDC
4 normally open contacts
Single-channel isolated outputs
WARNING RISK OF ELECTRIC SHOCK The terminal block must only be allowed to conduct voltage when it is inserted. It must not under any circumstances be removed or inserted when voltage is applied or have voltage applied to it when it is removed.
Status LEDs
Figure 72: DO4649
Pin Assignments
Light
Description
r
Off
Module supply not connected
r
Single green flash Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything OK
e
Steady red
Error or reset status
e+r
Red on/ Single green flash
Invalid firmware
1-4
Steady orange
Output status of the corresponding digital output
See the electrical diagram for pin assignments and usage of specific I/O modules.
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0000004004
LED
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Description | 100
DO9322 The DO9322 module is equipped with twelve outputs for 1-wire connections. The DO9322 is designed for source output wiring.
12 digital outputs
Source connection
1-wire connections
Integrated output protection
Status LEDs
0000003950
Figure 73: DO9322
Pin Assignments
LED
Light
Description
r
Off
Module supply not connected
r
Single green flash
Reset mode
r
Blinking green
Preoperational mode
r
Steady green
Run mode
e
Off
Module supply not connected or everything OK
e
Single red flash
Warning/Error on an I/O channel. Level monitoring for digital outputs has been triggered.
e+r
Red on/single green flash
Invalid firmware
1-12
Steady orange
Output status of the corresponding digital output
See the electrical diagram for pin assignments and usage of specific I/O modules.
3.12.4 Supervisor The supervisor is an optional monitoring and recording system. The supervisor is independent from the automatic controller and has its own software and hardware, including an independent measuring chain with dedicated sensors.
Controller Communication
There is a communication interface between the supervisor and the controller. It is used for sending process data, alarms and other information. The supervisor settings and functions are integrated into the controller's user interface. Supervisor alarms are handled just like the controllers alarms, likewise are sensors and signals handled the same way.
The supervisor monitors and records chamber temperatures and pressures during sterilization processes. If the sterilization readings are out of limits, the supervisor sends an alarm to the controller. The measurement data is sent to the controller which continuously compares the supervisor data with its own. If the deviation of the readings are out of limits, the sterilization will be reported as failed and alarms will be set.
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Treatment Supervision
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Description | 101
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.
1 1
2 1
1 1
2 1
1 2
2 2
1 2
2 2
11
21
12
22
SUPERVISOR
13
1 3
1 4
1 5
1 6
1 3
2 3
1 4
2 4
1 5
2 5
1 6
2 6
2 3
2 1
1 2
2 2
23
14
24
15
25
1 3
2 3
1 4
2 4
2 5
1 1
16
26
17
27
18
28
21
12
22
13
23
14
24
15
25
16
26
17
27
18
28
2 4
1 5
2 5
1 6
2 6
11
2 6
5
6 0000006558
Figure 74: Supervisor Hardware
Pos
Module
Wiring
1
CPU, X20CP0291, with Ethernet port.
K91
2
Power Supply, X20PS9502
K92
3
Analog input, X20AI2437
K93
Analog input, X20ATA312
K94
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Sensor
AI 22
PE29
( S- chamber pressure) AI 20
TE00/24
(S-chamber temp)
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4
Signal
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Description | 102
Pos
Module
Wiring
Signal
Sensor
AI 21
H-sterilizers: TE02/25
(H-sterilizers: Sload temp) (F-sterilizers: Chamber temp LTSF) 5
Digital Output, X20DO6639
K95
F-sterilizers: TE05/25
DO 00 (Chamber Depressurized) DO 03 (Supervisor Temp Reset)
6 (Option)
Analog input, X20ATA312
K96
AI23
TE03/26
(S-Effluent drain temp) AI 24
TE27
(Intellirack heater)
Supervisor Processor CP0291 This Compact CPU is used for the independent supervisor system.
Embedded μP 16/μP 25 with additional I/O processor
100 KB / 750 KB User SRAM
1 MB / 3 MB User FlashPROM
CP0291 and CP0292: Ethernet on-board
Only 37.5 mm wide
Battery-free
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For more information about the supervisor system, see Chapter 3.12.4 “Supervisor” on page 100.
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Description | 103
Status LEDs LED
Status
Description
R/E
Steady green
Application running
R/E
Steady red
Service mode
RDY
Steady yellow
Service or Boot mode
L/A
Steady green
A link to the Ethernet remote station has been established.
L/A
Blinking green
A link to the Ethernet remote station has been established. The LED blinks when Ethernet activity is present on the bus.
0000003948
Figure 75: CP0291
The picture below shows the operating and connection elements of CP0291 module.
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Operating and connection elements
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Description | 104
0000003993
Figure 76: CP0201 1 2 3 4
LED status indicators Node number switches IF1 - RS232, IF3 - CAN bus (with BB27) Terminal block for CPU and I/O supply, RS232 connection, CAN bus connection (with BB27) 5 Switch for CAN bus terminating resistor on BB27
3.12.5 Data and Printer Connections If connecting a printer or standalone computer to the sterilizer, the power supply to the computer should be taken from the same distribution system as the sterilizer is connected to. Common supply is important in order to avoid potential differences and risks of damage to the electronic circuits.
The sterilizer has one internal and one external ethernet. The external ethernet is used for network printers and network storage. The external network shall be connected to the POWERLINK port on the G1 panel on the control side.
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Ethernet
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Description | 105
The internal network is used for communication between the panels on the control and non-control side, supervisor and service computers. It is distributed by a switch located in the control electrical cabinet. The internal network connects to the ETH ports of the G1 panels and is distributed by a switch located in the control cabinet. Service computers shall be connected to the XD2 port on the back of the control electrical cabinet.
0000002861
Figure 77: Ethernet connection for service computers. For more information about connecting a service computer, see “Connecting the Service Computer” on page 125.
Each G1 panel has two USB 2. 0 ports located at the bottom of the panel. The ports on the control side panel can be used for backup, reporting and logging.
0000006539
Figure 78: Bottom back of the panel
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USB Connections
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Description | 106
ATTENTION Industrial Grade USB Memories Only Only use industrial grade single-level cell (SLC) USB 2.0 flash memories with the controller.
Connecting a USB memory 1.
Open the sterilizer's front on the control side.
2.
On the bottom of the G1 panel, locate a free USB port and insert the memory. Use an USB extension cable if there is not enouig room for the memory stick.
1.
Make sure that no ongoing file transfer is indicated on the panel's screen.
2.
Remove the memory from the USB port.
Disconnecting a USB memory
3.12.6 The Access Management System Access to the control system is regulated by Access Rights and User Groups. Each user group has a specific set of access rights, and once a user is made a member of a group, the user inherit those rights. Restricted sub-menus and actions are marked with a dimmed out user interface element, such as a button. This indicates that it cannot be operated or selected by the user.
Basic functions can be accessed without logging in to the system. For accessing restricted functions, the user must log in to a User Account belonging to a User Group to which Access Rights has been granted. A user account can belong to none, one or several user groups.
User Account Information
The system is delivered with predefined user accounts. The passwords for the predefined accounts shall be changed before taking the system at use. For information about managing accounts and changing passwords, .
Predefined User Account
Predefined Password
User Group Membership
SuperUser
123456
Super Users
Admin
243160
Administrators
This table describes the information about each user that is saved in the user partition file on the control system.
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User Accounts
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Description | 107
Account Information
Description
User name
The user name that the user logs in with. Must be a unique name with 1 to 10 characters. Can be changed from the Edit User page on the control panel.
Password
Password is case sensitive, cannot be shorter than 4 or longer than 64 characters. The system's password requirements can be configured by authorized service personnel. Can be changed from the Edit User page on the control panel.
Password time stamp
A time stamp from the latest password change, for keeping track of password expirations. The expiration time for passwords can be changed from the web interface. (require the option Extended data integry)
RFID tag
A RFID tag can be connected to a use account for facilitating logging in. (Requires the option RFID reader for user authentication.) RFID tags are unique and each tag can only be connected to one user account a time. RFID tags can be assigned to users from the control panel.
Full name
The users real name (or any other identification). Must be a name with 1 to 32 characters. Can be changed from the Edit User page on the control panel.
Locked
Indicates whether the account has been locked (due to maximum login attempts). The Locked status can be changed from the control panel.
Active status (Disabled or Enabled)
An account can be active or disabled. Disabled /Enabled can be changed from the control panel.
Groups
The user groups that the account belongs to. Can be changed from the Edit User page on the control panel.
The control system comes with predefined user groups. The groups or their access rights are not editable.
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Predefined User Groups
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Description | 108
User Group
Brief Description
Default Users
Access to basic operation. This is the default group for daily operators. As no logging in is required for this group and all users belongs to it by default, it cannot and does not need to be assigned to individual users.
SuperUser
Access to operations presupposing hygienic liability. A user in this group must log on to the controller.
Admin
Access to user management and HMI setup. A user in this group must log on to the controller.
Grp03 – Grp09
Reserved predefined groups without any access rights granted to them.
Restricted Services
Access to basic service settings through the web interface. Requires the software option Access to restricted service functions.
Authorized Service Personnel (not visible in the user group list)
Authorized service personnel have individual user names and passwords that are generated by Getinge's service organization. Service personnel accounts or group membership cannot be managed from the sterilizer. Access to service related operations. Personnel authorized to level 2 also have access to creating and customizing programs. A user in this group must log on to the controller.
The table below shows the access codes granted for each user group.
Group
-
A
Default Users (not logged in)
x
x
SuperUsers
x
x
Admin
x
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Z0
Z1
x x
x x
x
´x
x
x
x
x x
x
x x
Grp03 – Grp09 x
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Restricted Services
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Description | 109
Group
-
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Z0
Getinge Authorized Service Personnel Level 1
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Getinge Authorized Service Personnel Level 2
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
The following access codes defines the access areas for the control system:
Access code
Name
Access Area
-
None
Open and close doors Select program Start program without password requirements View active alarms and messages View alarm history View system information Change process view Enter load data Abort program
A
Basic process control
Restart after an alarm in standby mode Confirm alarms End program after an alarm
B
Extended process control
Continue program after an alarm before post treatment Make test of safety valve on steam generator Select steam from plant steam or steam generator
C
Basic setting
Display setting Sound setting Touchscreen calibration Language setting Enter load data
D
Extended setting
Load data header setting Date and time setting Timer setting Printer log interval setting
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Access Codes
Z1
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Description | 110
Access code E
Name
Access Area
Basic parameters
Quick edit parameters Edit program (A) parameters values
F
Extended parameters
Set/reset programs as Performance Qualified.
G
Basic service
View DI status View AI status
H
Extended service
View and change DO status View and change AO status Backup Steam generator water filling Steam generator blowdown Reset of interlock alarm
I
Basic user management
Change own password Change own full name
J
Extended user management
Add user Edit user Delete user
K
Basic documentation
Print last cycle Print test page
L
Extended documentation
Print alarm and message history Print program Print machine setting
M
Calibration
AI automatic calibration AI manual calibration Dose monitor automatic calibration Dose monitor manual calibration
N
Password level 1
End of alarmed program
O
Password level 2
Start of programs with raised password requirements.
P
Application control
Step program
Q
Program control
Not used
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Start program with password requirements
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Description | 111
Access code Z0
Name
Access Area
Getinge authorized service personnel. authorization level 1
Password minimum length Password alpha and numeric characters Password expiration period Maximum login attempts Automatic logout time Machine setup - user data Machine setup - configuration Machine setup - values Change cycle counter Change machine timer Date and time format setting Report language setting Pressure unit setting Temperature unit setting Network setting Printer setting Service messages viewing and setting Parameter info. setting. (Quick edit) Export/import configuration files Activate detailed log Activate network printing Active RFID reader Active USB storage Supervisor settings Barcode/RFID settings Getinge online settings T_Doc settings
etinge authorized service personnel, authorization level 2
Change alias name and number on Factory Programs Create/delete Custom Programs Modify ranges and values for Customizable-marked parameters Edit program type (A) parameters definition. Change limited start security Change Quick View Settings Set/reset Performance Qualified
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Z1
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Description | 112
3.12.7 Touchscreen Overview The touchscreen on the control panel is the interface for controlling the sterilizer.
Handling the Touchscreen
Always use fingers when interacting with the touchscreen. Never apply exaggerated force or use any kind of object when tapping the screen, as this may damage the liquid crystals.
Screen Layout
1
2
3
4 0000007901
Figure 79: Overview of the touchscreen panes 1 2 3 4
Menu pages have a colored frame that indicates the system's state and a navigation bar with navigation buttons and additional information. The frame's color indicates the state of the machine:
Black: Normal Operation during standby or a running process.
Green: Program finished but the machine has not been unloaded.
Yellow: Unconfirmed system information or warning message.
Red: Unconfirmed Alarm or a program finished with process faults.
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Menu Pages Layout
Open Door. Dimmed when unavailable. Close Door. Dimmed when unavailable. Start Program. Dimmed when unavailable. Content pane. The Select Program page is the start page during standby but pages like the Process Status View, Menu pages and Alarm messages are also displayed here.
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Description | 113
1
2
3
4
5
0000007902
Figure 80: Content pane for menu pages 1 Frame with colors that indicates the system's state. 2 Back button. Returns to the previous page. 3 Name of the current page. The dots represents the number of levels from the Main Menu. 4 Name of the user logged in. 5 Close button. Closes the current page and returns to the start screen.
Buttons and Icons This section describes Icons and buttons displayed on the couch screen. If an icon is dimmed, the function represented by the it is unavailable, for example due to access restrictions for the current logged in user.
Icon
Name
Description
Menu
Opens the Main menu.
Quick Edit Parameters
Opens a page for editing program parameters from the Select Program page.
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Info
Opens a page with more information for unfulfilled start conditions.
Login
Opens the Login page.
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This function is configurable)
Description | 114
Icon
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Name
Description
Logout
Logs off the current user.
Open Door
Opens the sterilizer door.
Close Door
Closes the sterilizer door.
Start Program
Starts the selected program.
Continue
Continues with the proposed action printed after the icon.
Abort
Opens a page for ending the running program.
Mute Alarm
Mutes the alarm signal
Settings
Opens the Settings sub menu.
Alarms & Messages
Opens the Alarms & Messages sub menu.
Process Control
Opens the Process control page.
Documentation
Opens the Documentation sub menu.
System
Opens the System sub menu.
Views
Opens the Views page.
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Icon
Name
Description
Back
Returns to the previous page.
Close
Closes the current view and jumps to the start page.
Guide
Guide for more information.
Confirm
Confirms an information messge or a an action.
Scroll buttons
Used for scrolling up or down in lists with more items than can be displayed at once.
Keyboards When the control system requires input from the user, a keyboard appears on the touch screen. The keyboard can be either in the form of a alphanumerical keyboard or a smaller numeric keyboard.
3.12.8 Progress Views When a program is running, the progress is displayed on the sterilizer's touchscreen. The progress information is available in two layouts, Circle View and Details View . Both views include the name and number of the current program, the remaining time of the program and buttons to access Menu and to abort the program. The Details View also includes information about current sub phase and current values from pressure and temperature sensors. The selected layout affects the displayed information window for Abort and Alarm Handling .
While a program is running, tap Menu , Views to select between the Circle View and the Details View layout.
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Switch Progress Information Layout
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Description | 116
3.12.9 The Select Program View The Select Program view is the start view when the sterilizer is in standby mode. For double door sterilizers, the Select Program view is only displayed on the control side. The Select Program view includes available sterilizer programs, status information and provides access to the main menu.
0000007200
Figure 81: Select Program view 1 2 3 4 5 6 7 8 9 10
Start Program. Turns active when the sterilizer is ready for start Close Door. Open Door. Scroll up button. Turns active if more programs are available. Scroll Down button. Turns active if more programs are available. Menu button. Opens the Main menu from which more functions are available. Edit button (Configurable), see “Edit Button” on page 116. Quick View information (Configurable), see “Quick View ” on page 117. Available programs. Note that the available programs may differ. If the sterilizer has more than 10 programs, use the scroll buttons to view more programs. Start Condition (Only displayed if program start is prevented)see “Start Condition” on page 117.
When a program is started, the Select Program page is replaced by the Process Status view.
The Edit button provides quick access to the Edit Parameters page, where Super Users and service personnel can edit the programs parameters. The Edit button is optional and it's display is configured by service personnel.
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Edit Button
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Quick View
Description | 117
The Quick view displays of summarizing program information:
Program Type:Group of programs for a specific usage.
The name and value of up to three selected parameters.
The Quick View is optional and it's display is configured by service personnel.
If the sterilizer is not ready for start, the unfulfilled start condition is displayed. For more information about the start condition and possible actions to take, tap the Info button. If several start conditions are unfulfilled, the first one that prevents start is displayed. Once that condition is fulfilled, the next one will be displayed. When all start conditions are fulfilled, the Start button becomes active and turns blue.
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Start Condition
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Description | 118
3.12.10 Menus Menu Tree Main • Settings • Documentation • Alarms & Messages • System • Process Control •Views
Settings
Alarms & Messages
Views
• Display Settings • Sound Settings • Touchscreen Calibration • Language • Load Data • Load Headers • Date & Time • Timers • Printer Settings
• Active Alarms & Messages • Alarms & Messages History
• Circle View • Details View
Documentation
System
• Print Last Cycle • Print Test Page • Print Alarms and Mes. History • Print Program • Print Machine Settings
• Information • Edit Parameters • Program Management • Access Management • Service • Configuration
Edit Parameters
Access Management
Configuration
• Edit Parameters (Basic) • Edit Parameters (Extended)
• Change Password • Change Full Name • Edit User • Add user
• Servers
Service
Program Management
Diagnostics
Calibration
Export to USB
• Analog Inputs • Analog Outputs • Digital Inputs • Digital Outputs
• Analog Input Automatic • Analog Input Manual • Dose Monitor Automatic • Dose Monitor Manual
• Export Report • Export Log • Export Audit Trail
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• Diagnostics • Calibration • Backup • Steam Generators • Export to USB
• Edit Program
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Description | 119
0000007926
Figure 82: Menu Tree
Opening the Menu
Pages for settings, configurations and additional functions can be accessed from the main menu. •
To open the menu, tap the Menu button, either on the Select Program view or the Process Status view.
Dimmed items are unavailable due to the machine's state or the access level granted to the current user logged in.
Logging in
To access menu items and functions that require authorization, log in to the system from the main menu. 1.
On the main menu page, tap Login . ð The Login page is now displayed.
2.
Enter credentials for User Name and Password in their respective fields.
3.
Tap Login to confirm. ð The Menu page is displayed again and the name of the logged in user is displayed in the navigation bar. You remain logged in until actively logging out, or the time limit for a logged in sessions is reached.
3.12.11 Settings Menu “Main menu è Settings” The Settings menu includes hardware and software control settings and the option to modify the load headers on printed reports.
Display Settings “Main menu è Settings è Display Settings” This view adjusts the touchscreen brightness and enables the screensaver function. The screensaver activation time can be set to 1-60 minutes. Setting the screensaver value to 0 will disable the screensaver.
Touchscreen Calibration “Main menu è Settings è Touchscreen Calibration”
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Calibration of the touchscreen is necessary in order to determine the precise coordinates of the point at which the screen is tapped. Perform a calibration when having problems with the touchscreen not responding correctly when tapping.
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To calibrate the touchscreen, tap in the center of each crosshair in a certain order. The new calibration is saved automatically.
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Figure 83: “The touchscreen calibration window”
Calibrating the Touchscreen 1.
Tap the crosshair in the top left corner.
2.
Tap the crosshair in the bottom right corner.
3.
Tap the crosshair in the top right corner.
4.
Tap the crosshair in the bottom left corner. ð The new calibration is saved.
An unsuccessful calibration will not be saved and the calibration is returned to previous settings.
Language “Main menu è Settings è Language” This view sets the control system language.
Changing Language 1.
Tap the selected language.
2.
Tap Save . ð The language on the panels is changed.
Load Headers
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“Main menu è Settings è Load Headers”
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Load headers are headers visible on the written report. A total of 6 load headers can be configured. Each load header can be set up to require mandatory or non-mandatory load data. For each mandatory load header, load data must manually be entered before starting the program. Load data for mandatory load headers are automatically erased when the program has finished.
Editing Load Headers 1.
Tap the text field in the Header column to edit the load header title.
2.
Set the Set value to On to make the load header mandatory.
3.
Tap Save .
Load Data “Main menu è Settings è Load Data” Load data is information manually entered before running a program. The information is visible on the printed report. A blue arrow indicates a mandatory load data input field, see Chapter “Load Headers” on page 120. It is not possible to start a program without entering information in a mandatory load data input field. Mandatory load data information is automatically erased when the program has finished.
Entering Load Data
The load data page is automatically displayed at program start when entering load data is required for the program. 1.
Tap the input field in the Load Data column and enter the data.
2.
Tap Save .
Date & Time “Main menu è Settings è Date & Time” This view sets the date and time for the control system.
Editing Date and Time 1.
Tap in the dark grey input field.
2.
Enter a new value.
3.
Tap Save .
Timers “Main menu è Settings è Timers” The Timer feature allows for automatic start of application specific functions. The start date and start time for each function is configured independently.
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Week day and time is used to start a timer. To inactivate a timer feature, uncheck all days of the week.
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Editing a Timer Setting 1.
Check the radio button for the timer function to edit.
2.
Tap Edit . ð The edit timer view is displayed.
3.
Set the time for the function to activate and select the weekdays to run the timer.
4.
Tap Save .
Printer Settings “Main menu è Settings è Printer Settings” This view sets the printer's log intervals.
Fast log interval: Sets how frequent the printer logs data for the fast part of the program, normally the sterilization phase.
Slow log interval: Sets how frequent the printer logs data for the slow part of the program.
Editing the Log Interval 1.
Tap in the input field for the interval to edit and enter a new value.
2.
Tap Save.
3.12.12 Documentation Menu “Main menu è Documentation” The Documentation menu include options for the printing of various control system reports. All reports are printed on the sterilizer printer and/or connected storage media.
Print Last Cycle “Main menu è Documentation è Print Last Cycle” •
Tap Print to print the last cycle's process report.
Print Test Page “Main menu è Documentation è Print Test Page” •
Tap Print to print a test page.
Print Alarms and Message History
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“Main menu è Documentation è Print Alarms & Messages History”
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This view prints triggered alarms and messages, generated by the control system.
Printing Alarms and Messages 1.
Select the number of alarms and messages to be printed.
2.
Check the radio button to select whether confirmations should be printed.
3.
Tap Continue . ð A confirmation window is displayed.
4.
Tap Print to confirm the printout.
Print Program “Main menu è Documentation è Print Program” Prints the parameter settings for a program. 1.
Tap the program to print.
2.
Tap Print .
Print Machine Settings “Main menu è Documentation è Print Machine Settings” Prints the sterilizer's machine settings. •
Tap Print to print the machine settings report.
3.12.13 Alarms and Messages Menu “Main menu è Alarms & Messages” From the Alarms & Messages menu information about alarms and messages is displayed.
Active Alarms and Messages
“Main menu è Alarms & Messages è Active Alarms & Messages” All active alarms and warnings are displayed in the Active Alarms & Messages view. The list includes both confirmed and non-confirmed messages. When an alarm or message has been confirmed and it has been resolved, the message is removed from the list.
“Main menu è Alarms & Messages è Alarms & Messages History” The last 200 alarms and messages are displayed in the Alarms & Messages History view. To see details about an alarm or message, tap the button in the More column.
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Alarms and Messages History
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3.12.14 Creating a Software Backup The sterilizer's software can be backed up to an USB memory. The backup will contain all software and settings. 1.
Open the sterilizer's front on the control side.
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Figure 84: Back of G1 Panel. 2.
On the bottom of the G1 panel, locate a free USB port and insert the memory. Use an USB extension cable if there is not enough room for the memory stick.
3.
On the touchscreen, tap Menu and log in as a service technician.
4.
Go to the Backup page: “System è Service è Backup”
5.
On the Backup page, tap the Select button for the USB memory to create the backup on. ð The Backup button now becomes active.
6.
Tap the Backup button. ð A progress bar indicates the progress of the backup file transfer.
7.
When the backup file transfer is finished, remove the USB memory and store it in a safe place.
3.12.15 Restoring the Sterilizer's Software For restoring a sterilizer´s software and settings, both backup files and data collected from reports are used.
Backup files from the sterilizer to restore.
Data to manually reenter after the restoration.
A service computer with the software Getinge Functions, or any other tool for setting the computers IP Address.
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The restore process requires:
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An ethernet cable.
A small screwdriver or a thin pen.
The controller software resides primarily on the main panel, but for models with supervisor or panel on the non-control side (called panel 1 during the restoration process), software resides on these units as well. If replacing these units, software from the backup shall be restored to the units directly. For a full restoration, the software on all units shall be restored, one at a time.
Data to Reenter after the Restore
Before starting the restoration procedure, make sure to have the data to reenter accessible:
Calibration data. Can be read from the machine settings report, calibration report or the latest calibration protocol
Cycle Counter information. Can be read from the latest process report or from the machine. “G1 Panel è System è Information” or “Web Interface è Machine settings”
Machine Timer information. Can be read from the machine. “G1 Panel è System è Information” or “Web Interface è Machine settings”
For supervisor models: Height above sea level. Can be read from the Peripherals web page. “Web Interface è Peripherals è Supervisor settings”
Unpacking the Backup Files 1.
Insert the USB memory with backup files to the service computer and open the USB memory drive in Windows explorer. In the root of the USB memory drive, the backups are stored in folders named by the backup time (Backup_YYYY.MM.DD_HH.MM.SS).
2.
In the folder for the backup to restore from, open the folder RestoreScript and double click the file Restore.exe. ð A file extraction dialog box is now displayed, with default setting to extract to the same folder as Restore.exe was run from.
3.
Make sure that the path for extracting the files does not contain any blank spaces and click Extract. ð When the extraction has completed, the file for starting the restore procedure is located in the folder for the extracted files.
The service computer shall be a Getinge configured windows computer, with possibility to set the IP address manually. In this procedure, the program Getinge Functions is used for setting the IP address. If having administrator rights to the computer, this can also be done from the Windows Control Panel. 1.
Make sure the sterilizer is powered on.
2.
On the service computer, open the program Getinge Functions.
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Connecting the Service Computer
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3.
In the network adapter list, select the LAN network adapter connected to the sterilizer. In the network adapter list, select the one for the connection to the sterilizer. Enter the following IP address and subnet mask and click Apply: New IP:
192.168.0.100
New Subnet:
255.255.255.0
(If setting the IP address from the Windows Control Panel, make sure that Default Gateway is empty.)
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4.
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Connect an ethernet cable from the service computer to the connection point for the task: Task
Connection point
Accessing the Web interface
The XD2 port on the back of the control cabinet.
Restoring software on the control side G1 panel
The ETH port at the bottom of the back of the control side G1 panel. Temporarily disconnect the existing cable during the connection of the service computer
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5.
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Task
Connection point
Restoring software on the The ETH port at the bottom of the back of the nonnon-control side G1 panel control side G1 panel. Temporarily disconnect the existing cable during the connection of the service computer
Restoring software on the supervisor
The Ethernet port at the bottom of the Supervisor, located in the control cabinet. Temporarily disconnect the existing cable during the connection of the service computer
6.
7.
On the sterilizer's touch screen, go to the System / Configuration menu and activate the web server.
On the service computer, open a web browser and type in the address http://192.168.0.32.
When finished with the task that required the service computer:
Disconnect the computer from the sterilizer.
In Getinge Functions, click Restore to restore the computer's previous IP settings.
This restoration procedures applies both to the panel on the control side (main panel) and on the non-control side (Panel 1). Before restoring the software, make sure that the backup files are unpacked on the service computer and the computer is connected to the panel to restore, see “Connecting the Service Computer” on page 125.
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Restoring a G1 Panel
For accessing the web interface:
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Getinge IQ restore tool guides through the restore procedure. Some steps like file transferring and configuration may take several minutes, do not cancel the restoration while waiting for these steps to complete. NOTE In the folder with the restore files, there might exist several files with the same base name but with different file extensions. For making it easier to select the right files, disable the option Hide extensions for known file types in Windows' Folder Options. 1.
On the service computer, in the folder for the unpacked backup files, run the Windows' batch file Restore.bat. ð This opens a cmd window and starts the program Getinge IQ restore tool from which the restoration is performed. Getinge IQ restore tool asks which parts of the software to restore. Answer yes for the device to restore the software on. Question
Description
Shall Supervisor be restored?
This restores the software of the supervisor. (Only displayed for sterilizers with Supervisors)
Shall Terminal 1 be restored?
This restores the software of the G1 panel on the non-control side. (Only displayed for sterilizers with panels on the non-control side)
Shall Main panel be restored?
This restores the software of the G1 panel on the control side together with the sterilizer's settings.
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2.
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3. When asked to connect the service computer directly to the panel and setting the panel in BOOT Mode:
Make sure that the service computer is connected correctly, see “Connecting the Service Computer” on page 125.
Press the reset button quickly with a small screwdriver and then press and hold it until the screen flashes.
ð When in Boot mode, the R/E LED lights red and the RDY/F LED lights yellow.
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Figure 85: Boot mode 4.
Continue with the restoration as guided by the Getinge IQ restore tool. ð During this part of the restoration, the progress is displayed by Getinge IQ restore tool and file transfer windows. At the end of the restoration the panel performs a Warmstart. This takes several minutes, do not cancel the restoration during this time. Restart the sterilizer when asked to.
6.
If restoring the main panel, reenter the following data:
Calibration Data. “G1 Panel è System è Service è Calibration è Analog Input Manual”
Cycle Counter and Machine Timer. “Web Interface è Machine Settings”
Supervisor: Height above sea level. “Web Interface è Peripherals è Supervisor Settings”
Before restoring the software, make sure that the backup files are unpacked on the service computer and the computer is connected to the supervisor, see “Connecting the Service Computer” on page 125. The restoring procedure is guided by the Getinge IQ restore tool. Some steps like file transferring and configuration may take several minutes, do not cancel the restoration while waiting for these steps to complete.
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Restoring the Supervisor
5.
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1.
Take a note of the current Node number switch settings on the front of the Supervisor CPU and set the upper switch to 2 and the lower switch to 1. For information about the node switches, see Chapter “Supervisor Processor CP0291” on page 102. .
2.
In the folder for the unpacked backup files, run the file Restore.bat. ð This opens a cmd window and starts the program Getinge IQ restore tool from which the restoration procedure is controlled.
3.
During the restoration process Getinge IQ restore tool asks which parts of the software to restore. On the question Shall the Supervisor be restored?, answer Yes .
4.
Continue with the restoration process as guided by the Getinge IQ restore tool. ð During this part of the restoration process, the progress is displayed by Getinge IQ restore tool and file transfer windows. At the end of the process the CPU performs a Warmstart. This takes several minutes, do not cancel the restoration during this time.
5.
When asked to Restart the sterilizer, set the node switches back to their previous positions and restart the sterilizer.
6.
Set the Supervisor Above Sea Level value from the web interface, see the .
3.12.16 Program Management This chapter describes how to customize programs and in other ways manage programs on the machine.
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The procedures described in this chapter must only be performed by level 2 authorized service personnel, with the access right Z1. Furthermore the program customizations must be made in consultation with the client's decontamination manager for regulatory decisions.
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Terms and Abbreviations Term
Description
Allowed value range
The maximum range a parameter can be set within by service personnel level 2. For factory programs the allowed value range is limited by the range set for the program. For custom programs, the allowed value range is limited by the range set for the program type.
Base program
The base program consists of a phase list with phases including sequential events like evacuation, steam injection and hold times. Each base program is designed for a specific application and may contain specific phases for that application. Thereby must the programs never be used for other applications than the intended use of their base program.
Custom programs
Custom programs are created by copying factory programs. Parameters in custom programs can be edited within the limits of the program type, which might be less restrictive than the original programs limits. Custom programs are not included in the type tests and require more comprehensive validation before use.
Factory program
A program developed and type tested by the factory. Parameters in factory programs can be edited without voiding the type testing made by the factory. Performance qualification is required for specific load configurations or parameter changes.
Installation Qualification (IQ)
Tests for establishing that the equipment has been provided and installed according to its specifications.
Load configuration
Specified configuration within the sterilization chamber of the items of fixed chamber parts and the numbers, types, distribution and orientation of product presented for sterilization.
Operational Qualification (OQ)
Tests for establishing that the equipment operates within predefined limits when used according to its operational procedures.
Parameter
Pressure, temperature and time are example of parameters defined in programs and used to control phases
Parameter access
The access level for a parameter:
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Info – Info parameters are displayed but their values cannot be edited. Customizable parameters are editable for level 2 service personnel. Adjustable – Adjustable parameters can be changed within the range specified in Value range by Super Users and service personnel.
The value a parameter is set to. 67H132E
Parameter value
Hidden –Hidden parameters are not displayed. Customizable parameters are visible and editable for level 2 service personnel.
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Term
Description
Performance Qualification (PQ)
Tests for establishing that the equipment performs according to a predetermined performance criteria and thereby yields product meeting its specification.
Performance Qualified
Denotes that a program has been subject to a Performance Qualification as described in EN ISO 17665. Each program on the sterilizer can be marked whether it is Performance Qualified or not. For programs that are not marked as performance qualified, an information message is displayed at program start.
Phase
A delimited portion of a base program that performs a specific process. An example of a phase is negative pulsing which makes repeated evacuations and steam injections between defined pressure and time limits.
Program
A program is derived from a program type and a base program. A program has specific parameter settings for an intended application. The program's parameter ranges and access types can be further limited by customization, but cannot be more allowing.
Program combination
A set of programs bundled together for a certain machine configuration and market segment. Program combinations may include optional programs; all programs in a combination must not be installed together on the machine.
Program configuration file
A file containing all programs on the controller, including their parameter settings and their appearance in the Select Program View on the controller's touchscreen.
Program type
The program type defines the maximum ranges for the parameters that are applicable for a particular application of the base program. The program type also defines if the parameter's access type shall be H (Hidden), I (Indicated) or A (Adjustable). It also defines whether the parameter's customization setting shall be Protected or Custom. For custom programs, parameters set to Custom will be customizable within the ranges of the program type.
Service personnel
In this document, the term service personnel refers to Getinge Authorized Service Personnel. There are two levels of authorization for service personnel:
Level 1: Authorization and access rights for performing maintenance, validations, repairs etc.
Level 2: Also includes authorization for creating customized programs.
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For more information regarding authorization and access rights, see Chapter 3.12.6 “The Access Management System” on page 106.
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Term
Description
Validation
Documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield a product complying with predetermined specification.
Value range
The range that a parameter value can be set within by super users and service personnel level 1. This can be the same range as the Allowed value range, or a more restrictive range if set so by service personnel.
Regulatory Aspects Each machine is provided with a combination of factory programs that meets the needs for most loads. Although the factory programs are versatile, some loads may require customized programs for successfully processing the load without damaging it.
Type Tests and Regulatory Compliance
The legal manufacturer of a medical device is among other things responsible to prove the safety and efficacy of the device and that it complies to applicable directives and standards. For example, for selling a sterilizer within the EEA (European Economic Area) , it shall be CE-marked and comply to the standards EN 285 and EN ISO 17665, among others. As part of proofing compliance, Getinge type tests the device and the factory programs, which includes testing of thermometric requirements, air removal and other challenges for standard reference loads. For custom programs with parameters set out-range of the original factory program, the client undertakes the responsibility for the program's efficacy and its regulatory compliance, including CE-marking.
When validating a factory program for a client the validation can refer to parts of the type tests, if the production load is less of a challenge than the type test load. When validating a custom program with parameters set out-range of the original factory program, the type tests are no longer applicable and far more extensive validation and documentation activities might be necessary on site. These activities include achieving, proofing and documenting:
Successful process performance
Personnel safety
Compliance to directives necessary for the CE marking or other national regulations.
If national regulations or the client's procedures require further documentation activities, these shall be performed as well.
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Extended Testing and Validation of Custom Programs
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NOTE Altering parameters related to the sterilization pretreatment or the sterilization will void the type testing and may require complete new type tests of the program during the validation. Before creating custom programs with out-range parameter settings, evaluate the possibility to achieve the desired result by adjusting the factory programs or changing the load pattern.
Validation and Qualification
A validation consists of:
Qualification
Description
Installation Qualification (IQ)
Tests for establishing that the equipment has been provided and installed according to its specifications.
Operational Qualification (OQ)
Tests for establishing that the equipment operates within predefined limits when used according to its operational procedures.
Performance Qualification (PQ)
Tests for establishing that the equipment performs according to a predetermined performance criteria and thereby yields product meeting its specification.
For factory programs results from the type tests may be referenced in the validation if the production load is less of a challenge than the reference load used in the type test. For custom programs, the machine's effectiveness must be established through a validation with documented evidence. Whether a complete validation including type testing shall be performed or parts can be referenced from type tests or previous validations depends on the type of customization, local regulations and if the intended load is less of a challenge than for the tests to refer. If not performing a full validation, the rational for this shall be documented with the validation report. A custom program shall not be used in production until it has been fully qualified. Only after a successful performance qualification the program can be marked as Performance Qualified .
The Legal manufacturer’s Responsibility
The client is responsible to:
Be informed of and comply with applicable national and local regulations.
Validate and document proof of a successful process result. This includes deciding, performing and documenting the tests and checks that shall be included in the validation. (This might be agreed to be performed by Getinge)
Getinge is the legal manufacturer of the machine and is as such responsible to:
Maintain design control
Handle deviations
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The Client's Responsibility
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Support service personnel
Do Corrective And Preventive Actions (CAPA)
Perform Field Safety Corrective Actions (FSCA)
Report to the Nation Competent Authorities (NCA) upon incidents.
Notify its authorized representatives and agents in case of incidents and FSCA’s on the behalf of NCA or where it is appropriate.
To fulfill this responsibility, the legal manufacturer must keep a technical file updated and accessible.
The Service Technician’s Responsibility
Program customization is only allowed to be done by service personnel authorized to level 2. The person who performs the program customization is responsible to: Create a baseline of applicable backups and documentation before starting the customization.
Make sure that the programs developed on site are within the machine’s intended application.
Develop the program in a safe manner and according to applicable standards and regulations. For sterilizers this includes: – EN ISO 17665-1 Sterilization of health care products – Moist heat –Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices –
EN 285 Sterilization – Steam sterilizers – Large sterilizers
–
ISO 14161 Sterilization of health care products – Biological indicators –Guidance for the selection, use and interpretation of results
Not mark the program as Performance Qualified until it is validated and approved by the client for production.
Name the program in a clear and unambiguous way.
Create clear and unambiguous program descriptions of the customized programs, to store in close vicinity to the machine.
If agreed with the client: Validate the program with documented evidence of its performance.
For AGS served machines: make sure that the naming and numbering of programs are consistent for all machines served by the same AGS.
For sterilizers: Collect and send the required documentation (listed below) to
[email protected].
The person who customizes programs on a sterilizer is responsible to send the following documentation to the legal manufacturer:
A copy of the updated program configuration file.
A copy of the validation report (PDF file).
Copies of the program descriptions for all customized programs (PDF files).
The information shall be sent by e-mail to:
[email protected]
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Documentation to Send to the Legal Manufacturer
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The legal manufacturer uses this documentation for updating the technical file and for handling service support calls. The information will not be shared with third parts, except on requests from authorities upon incidents according to national regulations. The legal manufacturer will not make any review of the customized programs, neither keep records as backups.
Possible Customizations The type of customizations that can be made depends on the service personnel's authorization level.
Authorization Level 1
Authorization Level 2
Getinge authorized service personnel level 1 have access to:
View parameter settings. Hidden program parameters are only displayed if the access is Adjustable for the program type.
Change value and range for parameters declared as Adjustable in the program, within the value range declared in the program. Note that if the range is restricted, this new range becomes the value range that service personnel level 1 can change within. For returning to the original value range, level 2 authorization is required.
View Program Attributes.
Mark and unmark programs as Performance Qualified.
Set the Start Security level.
Change parameter's access type to more restrictive settings.
Change Quick View settings.
Getinge authorized service personnel level 2 have access to:
All operations authorized to service personnel level 1.
Enable and disable programs.
Create and delete custom programs. For custom programs parameter ranges, values and access rights can be set within the limits of the program type even if the copied program has a more restrictive setting.
Change parameter values, ranges and access types for factory programs, within the original limits for the program.
Customize program buttons in the program list.
Edit program attributes.
Export and import program configurations.
Parameters Parameters' Customizability This section describes the factors that control which parameters that can be customized and in what extent.
The service personnel's authorization level.
The parameter's access type.
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The access to customizing the parameters is limited by:
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The parameter's customization setting.
The programs origin.
The customization access and the allowed ranges for the parameters of a specific program are displayed in the Program Parameters page in the web interface.
Authorization Level
Creating new programs and changing existing programs outside what is defined as Adjustable requires authorization level 2. For detailed information, see Chapter “Possible Customizations” on page 137.
Access type
The parameter's access type can be one of:
Hidden (H)
Informative (I)
Adjustable (A)
The access type can be customized to a more restrictive setting, but not to a more allowing setting.
Customization Setting
Program Origin
Each parameter has a customization setting which defines its customizability.
Customization setting
Description
Protected
Ranges and access types can only be set to less restrictive values than defined by the program
Custom
Ranges and access types can be set within the limits of the program type, even if these are more allowing than defined by the program.
Parameters in factory programs can only be customized within the limits defined for the program. The ranges and access type for the parameters can be customized to more restrictive settings, which limit the adjustability for super users and service personnel level 1. Since the settings only can be more restrictive, changes to a factory program's parameters does not affect its type test. Parameters in custom programs (created as copies of factory programs) can be customized within the limits for the program's Program Type. Since less restrictive ranges and settings can be set than for the original factory program, custom programs are not type tested and require more extensive testing and validation before use.
Pretreatment Parameters
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The pretreatment affects the air removal and thus the sterilization result. Changes of the pretreatment parameters are not supported within the sterilizer's type tests and requires validation of the sterilization result. For more information about regulations and validations, see Chapter “Regulatory Aspects” on page 134.
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3 4
2 1 0000007478
Figure 86: Pretreatment pulses 1 2 3 4
Negative pulses low level Negative pulses high level Positive pulses high level Positive pulses low level
WARNING Non-sterile Goods The sterilizing result depends on proper pre-treatment with effective vacuum pulses.
Negative Pulses
Sets the number of pulses from 1 to 5. More pulses will improve the air removal but may also dry out the load while fewer will impair the air removal.
Negative Pulses Low Level
Sets the low threshold of the negative pulse within the range from 5 to 50 kPa, where the lowest or the highest values are normally not used
Negative Pulses High Level
Sets the high threshold of the negative pulse within the range from 50 to 100 kPa. Lowering from 95 kPa (default) will impair the air removal and is normally not recommended.
Positive Pulses
Sets the number of pulses from 0 to 5. More pulses will improve the air removal but may also dry out the load while fewer will impair the air removal. 0 pulses will skip positive pulse sequence to obtain a sub-atmospheric pretreatment cycle.
Positive Pulses Low Level
Sets the low threshold of the positive pulse within the range from 100 to 200 kPa, with a default value of 110kPa. Lowering may slow down the process and a raise is not recommended as it will impair the air removal.
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The vacuum limit parameters must not be raised to compensate for reduced vacuum pump performance.
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Positive Pulses High Level
Sets the high threshold of the positive pulse within the range from 100 to 250 kPa, with a default value of 197.5 kPa. Lowering will impair the air removal and raising will consume more energy, slow down the process but also improve the air removal. A positive pulse pressure close to the sterilization pressure increases the risk of superheat in the process.
Ramped Cycle
Sets whether the pressure rate of change shall be ramp controlled. If creating a ramp controlled program, create it by copying an optics program, as their program types give access to more refined ramp control than the hard goods program types. If the sterilizer is equipped with air detector, it is recommended to turn off the air detector surveillance for ramp controlled programs, see “Air Detector Test” on page 142.
Ramp Down
Sets the pressure rate of change within the range from 5 to 100 kPa/min when decreasing the pressure. A pressure rate of change in the slower end of that range will prolong the cycle time and increase energy and water consumption significantly. Slow ramp control may also dry out a porous load and may then cause superheat in the process.
Ramp Up
Sets the pressure rate of change within the range from 5 to 100 kPa/min when increasing the pressure. A pressure rate of change in the slower end of that range will prolong the cycle time and increase energy and water consumption significantly. Slow ramp control may also dry out a porous load and may then cause superheat in the process.
Sterilization Parameters
Sterilization Temperature
The sterilization temperature can be set within the range from 105 to 135 °C.
Changing the sterilization temperature to values below the lower limit of the origin factory program's range is not supported within the sterilizer's type tests and requires validation of the sterilization result. For more information about regulations and validations, see Chapter “Regulatory Aspects” on page 134 For sterilizers with supervisor, the supervisor can only calculate and evaluate the hold time for the temperatures 121 °C and 134°C. If using other sterilization temperatures the supervisor will report the sterilization as failed even though an appropriate sterilization time is used. Thus it is recommended to disable the supervisor check if using other sterilization temperatures,see “Supervisor Check” on page 143 .
The sterilization time can be set within a range from 0 to 600 minutes. Changing the sterilization time to values below the lower limit of the origin factory program's range is not supported within the sterilizer's type tests and requires validation of the sterilization result. For more information about regulations and validations, see Chapter “Regulatory Aspects” on page 134
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Posttreatment Parameters Changes to adjustable posttreatment parameters within the ranges defined for the origin factory program are supported within the sterilizer's type test. Any other changes are not supported within the type tests and requires validation.
Vacuum Drying Time
The vacuum dry time can be set within a range from 0 to 90 minutes. This is an adjustable parameter that can be changed within the range of the origin factory program without voiding the type test. Vacuum drying is effective when the load is heated and the water boils off. Only a prolonged vacuum drying might not help in achieving a dry result as energy in the load will decrease during the drying time.
Vacuum Drying Low Level
Sets the low level for the vacuum drying within the range from 5 to 100 kPa, default value is 15 kPa. Changes to this parameter is not supported within the type test.
Steam Pulse
Sets the number of steam pulses. This is an adjustable parameter that can be changed within the range of the origin factory program without voiding the type test. Steam pulses can be used to add extra energy to the load during the drying phase.
Steam Pulse Low Level
Sets the low level for the steam pulse within the range from 10 to 70 kPa. Changes to this parameter is not supported within the type test.
Steam Pulse High Level
Sets the high level for the steam pulse within the range from 10 to 100 kPa. Changes to this parameter is not supported within the type test.
Steam Pulse Hold Time
Sets the hold time for the steam pulse within the range from 0 to 5 minutes. Changes to this parameter is not supported within the type test.
Air Pulse
Sets the number of air pulses. This is an adjustable parameter that can be changed within the range of the origin factory program without voiding the type test.
Air Pulse Low Level
Sets the low level for the air pulse within the range from 10 to 70 kPa. Changes to this parameter is not supported within the type test.
Air Pulse High Level
Sets the high level for the air pulse within the range from 10 to 100 kPa. Changes to this parameter is not supported within the type test.
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Air pulses can be used to add extra energy to the load during the drying phase.
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Description | 142
Sets the hold time for the air pulse within the range from 0 to 60 seconds. Changes to this parameter is not supported within the type test.
Non-Process Parameters This section describes parameters that does not affect the sterilization process but controls the sterilizer's behavior in other aspects.
Door Mode
Use Loaders
Controls the behavior of the door on the unloading side (only applicable for sterilizers with two doors).
0 = Automatic door opening.
1 = Manual door opening.
2 = No door opening.
This parameter is only applicable to sterilizers with loader/unloader. The default setting is 1 and it shall be set to 0 only for programs that shall not use the automatic loading equipment. Set this parameter to:
Load with Return
0 for sterilizers without automatic loading equipment.
1 for sterilizers with automatic loading equipment.
This parameter is only useful for basket loader type. This parameter is only applicable to sterilizers with basket type loader/ unloader. The default setting is 1 and it shall be set to 0 only for programs that shall not use the automatic loading equipment. Set this parameter to:
0 for load without return.
1 for load with return.
Service Cycle
This parameter sets whether the program is a service program or a production program. This parameter is normally protected and cannot be changed. When creating a custom program, always create it by copying a program of the correct kind.
Air Detector Test
This parameter is only applicable for sterilizers with the air detector hardware.
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Enabling the air detector test makes the program check whether the air detector temperature is above 80°C at 150 kPa(a) during the first positive pulse. There will also be a second check for sterile temperature during sterilization until half the cycle time has elapsed, to ensure that he temperature is maintained in the air detector. The process will abort if any of these checks fails.
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NOTE The air detector test is useful for 121°C and 134°C sterile temperature only and must not be enabled for other temperatures.
Air Detector Bypass
This parameter is only applicable for air detector test programs. It makes the program override the abort during process and just fail the program in the end. This makes it possible to use an induced leak and temperature sensors in the load to evaluate the suppression.
Jacket Start Interlock
This parameter sets whether a program can be started before the jacket has reached its correct temperature range.
0 = The program can be started even if the jacket is not within its temperature range. After start, the program will wait for the jacket to reach the correct temperature.
1= The program cannot be started until the jacket has reached the correct temperature.
Jacket start interlock shall be enabled for programs intended for wrapped and porous loads to prevent the load from drying during the waiting sequence, which would increase the risk of superheat.
Supervisor Check
The supervisor is an optional independent system that records data and checks the time and temperature during the sterilization phase. This parameter sets whether the supervisor shall check the time and temperature during the sterilization. The supervisor's data recording is not affected by this parameter. The supervisor can only calculate and evaluate the sterilization time for the temperatures 121 °C and 134°C. If using other sterilization temperatures the supervisor will report the sterilization as failed even though an appropriate sterilization time is used. Thus it is recommended to turn off the supervisor check if using other sterilization temperatures.
Creating a program baseline
The service computer shall be connected to the machine and its web interface, see “Connecting the Service Computer” on page 125.
The machine shall be in standby mode.
Authorization level 2 is required.
A program baseline contains the data for restoring the programs to a previous state, either by importing the complete program configuration file or by manually restoring previous parameter values.
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Baseline data
Usage
Program configuration file (Program backup)
The program configuration file contains the controller's complete set of programs with the button configuration for the Select Program View. It can be used as backup or for transferring the programs from one machine to another, as long as the machine type and the program configuration version is identical. Restoring the programs by importing a program configuration file will not overwrite non-program data like calibrations and user configurations, as an ordinary complete backup will.
Printed program description
For manually restoring the parameters of an individual program.
Printed machine settings
For manually verifying or restoring settings that might affect program execution.
Program configuration checksum
The checksum is unique for the program configuration and the parameter settings. After restoring programs, verify that the checksum matches the checksum from the baseline.
Procedure 1.
In the Web Interface, go to the Import/Export page: “Web Interface main page è Programs è Import/Export” For a description of the Import/Export page, see the .
2.
From the Information list, take a note of the Program Configuration checksum.
3.
Click the Download button to create a program configuration file. ð The controller now creates a program configuration file.
4.
On the G1 touchscreen, open the Print Program page. “Menu è Documentation è Print Program”
5.
Select each program to modify, one by one, and tap the Print button.
6.
On the G1 touchscreen, open the Print Machine Settings page and tap the Print button. “Menu è Documentation è Print Machine Settings”
Customizing the Select Program View This chapter describes how to customize the Select Program View on the controller's touch screen.
The service computer shall be connected to the machine and its web interface, see “Connecting the Service Computer” on page 125.
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Prerequisites
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Authorization level 2 is required.
Renaming a Program The attribute Name in Select Program View in the Attributes page is used for renaming programs. For factory programs this is an alias name as the original name cannot be changed. NOTE Naming Conventions When naming a program, use a descriptive name that implies the programs intended application. For more information, see “Name and Description Conventions” on page 148 1.
In the web interface, open the Program Attribute page: “Web Interface Main page è Programs è Attributes” For a description of the Attributes page,see the .
2.
From the Select Program list, select the program to rename. Factory programs are listed by their original names. To see the factory programs alias names, see the .
3.
In the Name in Select Program View field, enter a unique name for the program. Optionally, also edit the program number or other attributes of the program.
4.
Click Save changes .
5.
Update the program description, see Chapter “Updating the Program Descriptions” on page 148
1.
In the web interface, open the Program Buttons page:
Changing the Order of Programs
“Web Interface Main page è Programs è Buttons” For a description of the Program Buttons page, see the . 2.
In the Buttons in the Select Program View table, drag and drop the programs to the desired order. Optionally, add several instances of the same program to make it appear on several pages in the Select Program View. Click Save changes .
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Adding Program Buttons 1.
In the web interface, open the Program Buttons page. “Web Interface Main page è Programs è Buttons” For a description of the Program Buttons page, see the .
2.
In the Add button list, select the program to add and click Add . ð The program now appears at the end of the Buttons in the Select Program View list. Optionally, add several instances of the same program to make it appear on several pages in the Select Program View.
3.
Click Save changes .
4.
Update the program description, see Chapter “Updating the Program Descriptions” on page 148
1.
In the web interface, open the Program Buttons page.
Removing Program Buttons
“Web Interface Main page è Programs è Buttons” For a description of the Program Buttons page, see the . 2.
In the Buttons in the Select Program View table, click the Remove button for the program to remove from the Select Program View.
3.
Click Save changes .
4.
Update the program description, see Chapter “Updating the Program Descriptions” on page 148
Creating and Customizing Programs This section describes the workflow for creating custom program. Most actions for customizing programs requires authorization level 2. Service Personnel level 1 can however make changes to adjustable parameters of existing programs.
WARNING Fire Hazard Excessive drying may cause the goods to catch fire.
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Test changes to heating and drying related parameters early in the program development and stay clear of the door when opening the sterilizer.
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WARNING Non-sterile Goods The sterilizing result depends on proper pre-treatment with effective vacuum pulses. The vacuum limit parameters must not be raised to compensate for reduced vacuum pump performance.
WARNING Non-sterile Goods Changes to process parameters affect the sterilizing result. Consult the client's decontamination manager for re-validation and performance qualifications after changing process parameters.
WARNING Misuse of program types may jeopardize both the personnel's safety and the sterilization result. Make sure that the intended application for the custom program complies with the intended application for its program type. Read the intended application for the factory program to copy before creating a custom program. Also read the Intended Use and the contraindications stated in the User Manual.
The table below shows the workflow for creating a customized program and the considerations for achieving a safe, effective and properly documented program.
Step
Consideration
Creating a program, see the
Make sure to select a factory program intended for the same type of application as the custom program to create. Besides the configurable parameters, the program may contain hidden parameters and program steps that are essential for the type of application.
Configuring parameters, see the
Some parameter values and ranges can be set outside the allowed range of the origin programs.
When setting parameter values and ranges, make sure to keep within safe limits for the process and intended load.
It is a good practice to test changes in parameter values in small increments to avoid safety risks.
Whether a program shall be validated and tested for performance qualification shall be decided in consultation with the client's decontamination manager.
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The program name shall be descriptive and imply the intended application. For detailed information about naming conventions, see “Name and Description Conventions” on page 148
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Description | 148
Consideration
Updating the program descriptions,see Chapter “Updating the Program Descriptions” on page 148
Editing the Attributes, see the
Updating the technical file, see Chapter “Regulatory Aspects” on page 134.
The program descriptions in vicinity to the machine shall include all the program that can be started on the machine.
If a program have been removed from the Select Program view, its description shall be removed or marked as obsolete as well.
Make sure that the program description contains updated ranges and values for all adjustable and informative parameters.
For new or edited programs, the intended application shall be stated in the program description in an unambiguous way.
Whether a program shall be validated and tested for performance qualification shall be decided in consultation with the client's decontamination manager.
Set the start security level in consultation with the client's decontamination manager.
Send the updated program code, program description and validation report by email to Getinge:
[email protected] Check with the clients decontamination manager if their procedures or regulations require further documentation.
Name and Description Conventions
A program's name must be written in a clear and unambiguous way to prevent misuse that jeopardizes the personnel's safety or the sterility of the goods.
The program name shall be descriptive and imply the intended application. The intended application of the custom program must be within that of the original factory program or its Program Type.
For programs intended for open liquid loads the name and description shall describe that it is intended for liquids in open containers. Closed containers shall not be mentioned in the name or description.
For programs intended for hard goods, the word liquid and related words like bottle, shall not be used.
The name shall indicate whether it is a production program or a maintenance program.
The name and the program number must be unique.
Set the program names in consultation with the client's decontamination manager for making sure the names are clear and unambiguous for the personnel.
Updating the Program Descriptions An updated description of the complete program combination for the machine shall be available in close vicinity to the machine. Each program is described on a separate page. Templates for creating the descriptions are available in SIS (Getinge Service Information System).
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Creating a description for new, renamed and modified programs
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1.
Open the program description template for the program. For custom programs, use the template for the factory program that the custom program where created from.
2.
Update the description with the new information:
Name
Intended Application. The intended application shall be written in an unambiguous way and be within the application area stated for the origin program.
Parameter ranges and values shall be specified for all adjustable and informative parameters.
3.
Print the updated description. If possible also laminate the description.
4.
Place the description with the other descriptions that are posted in vicinity to the machine, together with the quick guide. If the new description replaces an existing one, remove or mark the obsolete description.
5.
When the program is validated, send the program description together with the other required documentation for the customization to Getinge, see “Documentation to Send to the Legal Manufacturer” on page 136. Getinge will return an updated printed and laminated program combination description. Replace the manually edited description with the new one.
Updating the Program Combination Description when removing programs 1.
When removing programs from the Select Program View , remove the program description from the program description collection. If the program description is on a page with other programs, mark the program as obsolete.
2.
Send the changes to the program combination ( a note of the programs that have been removed) together with the other required documentation for the customization to Getinge, see “Documentation to Send to the Legal Manufacturer” on page 136. Getinge will return an updated printed and laminated program combination description. Replace the manually edited description with the new one.
Managing Program Configuration Files Exporting a Program Configuration File 1.
In the Web Interface, go to the Import/Export page: “Web Interface main page è Programs è Import/Export” For a description of the Import/Export page, see the .
2.
From the Information list, take a note of the Program Configuration checksum.
3.
Click the Download button to create a program configuration file.
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ð The controller now creates a program configuration file.
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4.
In the Save file dialog box, select a location for the program configuration file. NOTE File Handling Tip The syntax of the program configuration file name is checked when uploading the file. Use folders to organize the files instead of renaming or keep the syntax _ if renaming the program configuration file.
Importing a Program Configuration ATTENTION Importing a program configuration file will replace the complete set of programs including their parameter settings and their appearance in the Select Program View on the controller's touchscreen. Before importing a program configuration file:
Export a program configuration file.
Make a complete backup of the controller's software, see Chapter 3.12.14 “Creating a Software Backup” on page 124.
The program configuration file to import must be:
1.
From the same machine type
From a matching program configuration version.
Complete and unmodified. In the Web Interface, go to the Import/Export page: “Web Interface main page è Programs è Import/Export” For a description of the Import/Export page, see the .
2.
Click the Upload button and select the program configuration file to import. ð At upload the file name is checked. If the name does not comply to the expected syntax, you will be asked to verify that the correct file is selected. At import the machine type, program configuration version and file integrity is checked. If all checks are passed, the program configuration file will be imported and the programs on the controller will be replaced by the programs in the file.
3.
Restart the machine. If the import fails, the previous program configuration will be loaded again. Instructions are displayed on the touch screen. In the Information list, check that the Program Configuration checksum matches the one for the imported program configuration file.
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Preventive Maintenance This chapter describes generic procedures for preventive maintenance. Periodic maintenance of the sterilizer prevents underperforming systems. In addition to the actions listed here, safety checks shall also be performed, see Chapter 4.4 “Safety Checks” on page 156.
4.1 Prerequisites The pre-requisites for performing preventive maintenance on the sterilizer includes the following items:
Metric 5 mm ball point hex key, with 150 mm T-handle
Drain valve extractor tool (no. 890610008), or a long M6 threaded bolt, for removal of the check valve FCV12AD
Phosphoric acid based descaler
Clamp Ampere meter
Multimeter
Lighted inspection mirror
Documentation of the latest performed validation
Plastic measuring gauge (3 mm)
Temperature reference instrument (heat source)
Calibration ice bath
Pressure reference instrument
Molykote 111
Molykote 1000
Teflon tape
6 meter of 4mm air hose
Getinge Assured Bowie & Dick Test, or equivalent For F series sterilizers: Safety gloves and personal protective equipment for formaldehyde
–
For Air Detector Test: Test pressure gauge with a range of 0 kPa to 16 kPa
–
Reference test pack
–
Two thermocouple temperature-measurement leads connected to an external temperature measurement instrument
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. Defilements in the water can cause limescale or corrosion. A high water quality is essential to ensure the functionality of the sterilizer, see Chapter 5.1 “Water Quality” on page 169.
For information about spare parts contact an authorized service representative, see “Getinge Service” on page 14.
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Spare Parts
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4.2 PM Actions when Media and Power is Turned Off This list contain the PM Actions to perform when power and media is 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 (chalk deposits) and impurities through the sight glass. Descale and clean the vessel if limescale or impurities are present.
2000 cycles or 1 year, whichever comes first.
Pressure Vessel
Steam Generator Sight Glass
Steam Generator Heating Elements
When inspecting the water level in the steam generator, or when looking for limescale, the sight glass must be in good condition.
Inspect at every service occasion.
If there are impurities stuck on the inside of the sight glass, or if the glass has turned opaque due to exposure to the water, replace the sight glass.
Replace when needed.
The upper elements can be inspected through the vessel's sight glass. If any signs of limescale or damages are visible, all heating elements shall be removed and inspected, cleaned or replaced.
2000 cycles or 1 year, whichever comes first.
When reassembling a heating element, replace the gasket.
Normal Water Level Sensor
Inspect the normal water level sensor for limescale. Clean if limescale is present. Check the function of the sensor when refilling the steam generator.
Steam Generator
Clean the tank, strainer, and check the function of the float valve.
Feed water Tank
see Chapter “Cleaning and Inspecting Tank B16” on page 53
Check Valves
Disassemble and clean the parts. Replace the gasket. Verify that the kernel moves freely. Perform the service on the the following valves:
R07 Steam Generator
R11 Jacket drain
R16 Degassing filter
FCV12 Check valve in chamber drain
2000 cycles or 1 year, whichever comes first
2000 cycles or 1 year, whichever comes first.
R07: 2000 cycles or 1 year, whichever comes first. R11, R16, FCV12: 4000 cycles or 2 year, whichever comes first.
After servicing FCV12, a dynamic pressure test shall be performed.
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Steam Generator
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Disassemble, clean and inspect all strainers. Replace if damaged. For detailed information, see Chapter 3.2.1 “Strainers” on page 24.
2000 cycles or 1 year, whichever comes first.
Restrictors
Clean all restrictors on steam piping. Replace the restrictor if it is worn or damaged.
2000 cycles or 1 year, whichever comes first.
Power Cables and Connections
High voltage cables. Make sure that the power to the sterilizer is switched off before touching any power cables or connections points, especially the incoming power cable to the machine, all contactors and both earth and zero phase. Check that power cables and connection points are tight and in good condition.
1000 cycles or 6 month, whichever comes first.
For information about tightening torque's, see Chapter 3.10 “Electrical Power Cabinet” on page 82.
Contactors
Replace the contactors label them with the replacement date. Insert the date in the logbook and the PM protocol.
Contactor Q113: 4000 cycles or 2 years, whichever comes first. Other contactors: 9000 cycles or 4 years, whichever comes first.
Gaskets should always be replaced when performing preventive maintenance on the machine to ensure that they are in good condition. see Chapter 3.3.7 “Replacing the Door Gasket” on page 48
Pressure Gauges
Check that the pressure gauges are indicating within the marked acceptance range at atmosphere pressure. see Chapter 3.2.4 “ Pressure Gauges” on page 32
Piston Valves
Disassemble, clean and inspect the parts. Replace the gaskets and the seat seal. If the seat is damaged, replace the valve. Assemble and check the function.
1000 cycles or every 6 months, whichever comes first.
2000 cycles or 1 year, whichever comes first.
FV11: 4000 cycles or 2 year, whichever comes first. Other steam valves:2000 cycles or 1 year, whichever comes first. Water and air valves: 10000 cycles or every 5th year, whichever comes first.
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Door Gaskets
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Flush the vacuum pump sealant water tank to clean it. For detailed information, see the .
When noise from the pump or poor vacuum performance have been reported.
4.3 PM Actions when Restarted This list contains tests and actions to perform when the sterilizer is powered on.
Item
Description
Door, mechanical movement
Interval
Check that the motion of the door is even and smooth and that it does not 2000 cycles or 1 brush against anything during its motion see the . year, whichever comes first. Check that the door gaps are 2 to 2.5 mm see Chapter 3.3.4 “Measuring the Door Gap” on page 43.
Vacuum Pump Water Tank
Steam Trap
Check that the door speed for opening/closing is 10-15 seconds see Chapter 3.3.5 “Adjusting the Door Speed” on page 44.
Verify that there is water in the tank that supplies the vacuum pump with sealant 1000 cycles or water. Check the function of the vacuum pump's level switch. every 6 months, whichever comes first.
When working on the steam traps, keep in mind that there is hot steam in the system.
At every service occasion
When the sterilizer is in standby mode with a 134 °C program selected:
Check that the jacket temperature stabilizes around 132 °C. Loosen the piping for condensate outlet and check the outlet of the steam trap. The steam trap should open, release condensate and close again.
If the steam trap does not open and close as expected, see Chapter 3.5.8 “ Steam Trap Maintenance” on page 66.
Printer
Check the status of the printer equipment. Make sure that there is enough paper At every service and that the toner cartridge or color band is in good condition. occasion
Battery backup
Check that the battery backup is activated at power failure.
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Stem generator
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Check the water level through the sightglass when refilling the steam generator.
At every service occasion.
3-Phase Power Supply
Verify that the power consumption is evenly distributed over the phases by measuring the current in the phases during load with a clamp ampere meter.
At every service occasion
Steam Generator
Verify that the feed water pump refills the steam generator from the low level to normal level within 10 minutes and that there are no leakage.
2000 cycles or every 1 year
Water level
Feed Water Pump
Dynamic Sterilizer Chamber Pressure Test
Steam Sample
1
Perform a leak rate test. The test must pass for continuing.
2
Run a program for wrapped goods, with an empty chamber.
3
Review the process report and check that the pressure rate of change does not exceed the value specified in the program description.
At Validation After service or repair of:
Perform a steam sample and analyze the steam condensate to determine the steam quality and cleanness.
Drain valves
Sensors, I/O modules or other parts that control chamber pressure.
500 cycles or every 3 months
The test shall be performed in accordance with EN285.
Inspect for leakage at piping components, connections, heating elements and level sensors on the steam generator and process equipment.
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Leakage
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Note! The tests don't have to be performed as part of the preventive maintenance if procedures for revalidation prescribes calibration of the sensors within these intervals.
2000 cycles or every year
Sensors to check:
PE05 Chamber pressure
PE 29 Supervisor chamber pressure (if present)
TE00 Chamber temperature
TE24 Supervisor Chamber temperature (if present)
TE02 Load temperature (if present)
TE25 Supervisor load temperature (if present)
Check the readout of the temperature sensors with a calibrated reference thermocouple at the sterilizer's highest possible sterilization temperature. If any sensor readout deviates more than +/-0,5 °C from the temperature reference, a calibration needs to be performed. Make sure that insertion depth of the chamber temp sensor (TE00) matches the measurement from the latest validation. If no validation has been performed yet, the factory setting shall be used. Check the readout from the pressure sensors with a calibrated pressure gauge at 325 kPa (47.14 psia). If the sensor readout deviates more than ± 0.8 kPa (0.12 psi)psi) a calibration needs to be performed.
Leak Test
Run a leak test program to make sure that there are no leakage into the chamber.
At every service occasion
Inform the client that local regulations might prescribe procedures for performing recurrent tests as part of daily use.
Bowie & Dick Test
Perform a Getinge Assured Bowie & Dick test to verify the sterilization process. During the test, inspect the piping and components for leakage.
After every service occasion
Make sure that cables and plastic or rubber hoses are not in contact with hot parts of the sterilizer. Inform the client that local regulations might prescribe procedures for performing recurrent tests as part of daily use.
Vacuum Pump
Disconnect the air hose to the vacuum pump's cavitation protection. Note that the pipes in front of the vacuum pump might be hot.
Activate the valve FV22 (DO17) and check that air flows through the hose.
Cavitation Protection
2000 cycles or every year
4.4 Safety Checks
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This chapter describes safety checks for the sterilizer. If no other interval is stated, the checks hall be performed yearly (corresponding to 2000 cycles, whichever comes first) or after any larger intervention with the machine.
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Before performing the safety checks, make sure that the media supply is within the ranges specified in the Technical Data Sheet.
4.4.1 Door Mechanism Safety Checks WARNING Risk of Crushing Be very careful if the door remains fastened to the seal. When the door is detached from the seal it will fall down and may cause injury.
WARNING PINCH INJURY There is a risk of pinch injury when working close to the door latch. The door is locked by a spring loaded door latch within 20 seconds after it has been closed.
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For the door lock to work properly, the tolerances shall be adjusted according to the picture below:
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0000003473
Figure 87: Door latch in door closed position Door latch overlap: 10 to 16 mm. Door latch clearance: 2 ± 0.5 mm. Door Plate Cylinder fastening nut Door lock cylinder, HX00 or HX01 (second door) Air connection Interlock switch S100 or S110 (second door) Latch gripper Latch cylinder screw Door latch
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A B 1 2 3 4 5 6 7 8
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0000007614
Figure 88: Door latch fastening 8 Door latch 9 Latch fastening nuts The sterilizer shall be powered on and in standby mode. 1.
Open the sterilizer's front, see Chapter 3.3.2 “Opening the Sterilizer's Front” on page 41.
2.
Close the door and place a trestle or other support under it.
3.
Check that the bottom of the door plate (1) aligns with the bottom of the gasket frame. For adjustments, see the .
4.
Check that the door latch overlap (A) is 10 to 16 mm from the door latch outer end (excluding the plastic protection) to the top of the gasket groove. Adjust the door latch if necessary, see “Adjusting the Door Latch Overlap” on page 160.
5.
Check that the door latch clearance (B) is 2 ± 0.5 mm from the top of the door latch to the bottom of the door plate. Adjust the door latch if necessary, see “Adjusting the Door Latch Clearance” on page 160.
6.
Push in the door latch by hand. Slowly release the latch and listen for the click when the interlock switch activates: It should be within the door latch overlap.
7.
Check that the motion of the door hatch mechanism is distinct by opening and closing the door lock. This can be done in one of the following ways:
Tap the Open Door and Close Door buttons on the touch screen.
Open and close the air valve for the door latch cylinder manually: FV00 or FV01.
Manually set the signal to open and close the door latch valve: Open Door 1 or Open Door 2 .
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Checking the Door Lock
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8.
Check that the screws for the lock mechanism are tight and in good condition.
1.
Make sure that the door is supported by a trestle.
2.
Loosen the latch cylinder screw (7).
3.
Remove the air hose from the air connection (4)
4.
Unscrew the latch cylinder fastening nut (2) and tilt the cylinder downwards, so the air hose connection goes free from the chamber bottom when turning the cylinder.
5.
Adjust the position of the door latch overlap by turning the cylinder (3).
6.
Reconnect the air hose and tighten the cylinder fastening nut.
7.
Tighten the latch cylinder screw to 9.3 N·m.
8.
Recheck the door lock, see “Checking the Door Lock” on page 159.
1.
Make sure that the door is supported by a trestle.
2.
Loosen the latch fastening nuts (9).
3.
Adjust the height of the door latch (8) by moving it upwards/downwards by hand.
Adjusting the Door Latch Overlap
Adjusting the Door Latch Clearance
The clearance between the top of the latch and the bottom of the door (B) shall be 2 ± 0.5 mm. 4.
Retighten the latch fastening nuts to 9.3 N·m.
5.
Recheck the door lock, see “Checking the Door Lock” on page 159.
1.
Close the door.
2.
While the door closes, push down the middle of the pinch protection plate.
3.
Repeat the test for the corners of the pinch protection plate.
Checking the Door Pinch Protection
ð The door shall open again anywhere the plate is pressed down. Otherwise, adjust the door closing speed, see Chapter 3.3.5 “Adjusting the Door Speed” on page 44
4.4.2 Emergency Stop Button Safety Checks Check that the door stops when pressing the emergency stop button, both when closing and opening the door.
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Emergency Stop Button, During Door Movement
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For double door sterilizers, check the function on both doors.
Emergency Stop Button, During a Running Process 1.
Start a sterilization process.
2.
Wait for the gasket to be pressurized and the door sealed.
3.
Measure the voltage on the digital output K58:21 and wait for a signal (about 24V), which enables the media to chamber valves.
4.
Press the emergency stop button and check the following:
The alarm 21004 Emergency Stop is set.
The running program is stopped.
The voltage on K58:21 is dropped, which disables the media to chamber valves.
5.
Reset the emergency stop.
6.
For double door sterilizers, perform the test on both sides.
4.4.3 Interlock Safety Checks Door Closed Interlock Switch
The door interlock switch S100 (and S110 for second door) prevents the gasket from being pressurized before the door is fully closed. 1.
Close the door and check that there is voltage (about 24 V) on the X3:50 terminal.
2.
Open the door and check that the voltage disappears from X3:50.
3.
For double door sterilizers, repeat the test for the door on the other side.
If the test fails: The door latch overlap might need to be adjusted for achieving enough movement of the switch arm.
Troubleshoot the interlock system. For information about the interlock system's components and wiring, see the electrical diagram.
The door opening is interlocked when the pressure is above 120 kPa.
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Door Opening Interlock
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1.
Start a sterilization program.
2.
Open the Details Process View and watch the Chamber Pressure (PE05)
0000007203
Figure 89: “Main Menu è Views è Details View” 3.
When the chamber pressure rises above 120 kPa (a), the relay K41 shall be deactivated.
4.4.4 Safety Relief Valve Checks The safety relief valve checks described in this section shall be performed at installation and every 6 month or by 1000 cycles, which ever comes first. If local or national regulations prescribe other tests or intervals, these shall be complied with as well.
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Safety valves that do not pass the tests shall be replaced.
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Testing the Steam Generator Safety Relief Valve from the Control System
0000007652
Figure 90: “Main Menu è System è Service è Steam Generators” 1.
On the Steam Generators page, tap Safety Valve Test . ð The button's check mark turns blue during the test and the pressure increases for testing the safety valve. The test program monitors the pressure and when the pressure drops due to successful opening of the safety relief valve the program ends.
2.
To manually end the test, tap Safety Valve Test again.
4.4.5 Steam Generator Safety Checks The low-level switch LS05 protects the steam generator from boiling dry by turning the heating off at critical low levels. 1.
For electrical steam generators, deactivate the fuses for the heating elements:
2.
F110
F111
F112
Open the Digital Outputs page and Set the signal Automatic Blow Down For Steam Generator (DO 29) to manual mode and On . “Main Menu è System è Service è Diagnostics è Digital Outputs”
3.
Open the Digital Inputs page. “Main Menu è System è Service è Diagnostics è Digital Inputs” When the water level drops below the minimum level (marked by the sight glass), the signal Steam Generator Cut off Level (DI 21) shall be activated.
4.
Set Automatic Blow Down For Steam Generator (DO 29) back to automatic mode.
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Low Level Protection
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If the test fails:
Overfill Protection
Remove the low water level switch and check that it is free from limescale (chalk deposits) and that the switch arm moves freely, see the .
Troubleshoot the connections for the low water level switch.
The overfill protection prevents the steam generator from overfilling and possible also filling the chamber with water. It consists of a timer that stops the feedwater pump and sets the alarm Feed water fill time if the normal water level is not reached within 4 minutes after the feed water pump started. 1.
Close the ball valve H16 located between the feed water pump and the steam generator. Note that the surrounding pipes might be hot.
2.
Open the Steam to Chamber valve: Open the Blowdown valve by manually actuating the pilot valve YV23 until the water level is below the normal water level (the light on the normal level switchLS04 turns off).
High Temperature Protection (for Electric Steam Generators)
3.
When the feed water pump starts, measure the time until the alarm Feed water fill time is set and the feed water pump stops (4 minutes).
4.
Open the ball valve H16 again. Note that the surrounding pipes might be hot.
5.
Confirm the alarm.
The High Temperature protection TS21 cuts the power to the heating elements if the temperature of the steam rises above normal values. For more information, see Chapter 3.5.2 “High Temperature Protection” on page 57. The high temperature protection shall be tested every 5th year. To test the high temperature protection, TS21's sensor shall be heated to a temperature between 160 and 200 °C. This can be done either by heating in a regulated heat source (like an oil bath) or by a soldering iron.
Testing the High Temperature Protection Using a Regulated Heat Source 1.
Remove TS21's temperature sensor from the steam generator and place it in a heat source set at 170°C.
2.
When the sensor is heated, TS21 shall switch (indicated by a clicking sound from the junction box).
3.
Remove the sensor from the heat source and clean it.
4.
Open the Digital Inputs page and check that the signal Steam Generator OK is set to 0.
5.
Reassemble the sensor on the steam generator. To make sure that the sensor tip is freely fitted in the tube, insert it fully and then pull it back approximately 2 mm.
6.
Open the cover of TS21's junction box and press the reset button. Note that the surrounding pipes might be hot.
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“Main Menu è System è Service è Diagnostics è Digital Inputs”
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Testing the High Temperature Protection using a Soldering Iron 1.
Remove TS21's temperature sensor from the steam generator and wrap it with a cold soldering iron and a thermocouple in a cotton cloth. Make sure that the thermocouple and the TS21 sensor are in contact with each other.
2.
Turn on the soldering iron and watch the thermocouple's display. ATTENTION The sensor must not be heated above 265 °C. Once the high temperature protection has switched, turn off and remove the soldering iron to avoid overheating and read the value of the thermocouple's display. Replace the sensor if it gets overheated during the test. Within the temperature range from 160 to 200 °C, the high temperature protection shall switch, indicated by a clicking sound from the junction box.
3.
Open the Digital Inputs page and check that the signal Steam Generator OK is set to 0. “Main Menu è System è Service è Diagnostics è Digital Inputs”
4.
Reassemble the sensor on the steam generator. To make sure that the sensor tip is freely fitted in the tube, insert it fully and then pull it back approximately 2 mm.
5.
Open the cover of TS21's junction box and press the reset button. Note that the surrounding pipes might be hot.
4.5 Cleaning
Area to clean
Detergent to use
Cleaning method
External stainless steel surfaces outside the sterilizer
A microfiber cloth and 70% ethanol surface disinfectant.
Be careful when cleaning painted surfaces, labels and plastic parts see “External Cleaning” on page 166.
The control panel surface and manometers
A microfiber cloth and 70% ethanol surface disinfectant.
Details see “Cleaning the Control Panel Surface” on page 166.
The touchscreen
A microfiber cloth and 70% ethanol surface disinfectant.
Lightly wiping see “Cleaning the Touchscreen” on page 166.
The inside of the chamber including the door A lint free cloth moistened with gasket demineralized water.
Details see “Cleaning the Chamber and Gasket” on page 166.
The strainer in the chamber floor drain
Manually remove contaminations (paper, indicators) see “Cleaning the Chamber and Gasket” on page 166.
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During maintenance clean the parts according to the recommended methods below.
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External Cleaning
Clean stainless steel surfaces on the outside of the sterilizer with a microfiber cloth and a 70% ethanol surface disinfectant. Be careful when cleaning painted surfaces, labels and plastic parts.
Cleaning the Control Panel Surface
The control panel surface is made of a white, solid and homogeneous material that requires daily cleaning with a microfiber cloth and a 70% ethanol surface disinfectant. The control panel buttons are wiped with a microfiber cloth and a 70% ethanol surface disinfectant. 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 descaler, 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 and Gasket WARNING HOT SURFACE The door and the chamber can be hot and may cause burns.
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The sterilizer must cool down before cleaning. Turn off the sterilizer and allow to cool, for example overnight.
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1
Door stop block
1.
With the door closed, remove the door stop block
2.
Open the sterilizer door. ð The door now opens fully so the gasket groove can be accessed.
3.
Turn the Interlock Key to the locked position and remove the key. ð The sterilizer door is blocked and jacket heating shuts off.
4.
Inspect the gasket and wipe it lightly with a lint free cloth moistened with demineralized water.
5.
Control the strainer in the chamber floor drain and manually remove any contaminations (Like lint or paper rests). If necessary, remove the strainer during the cleaning. see “Cleaning the Chamber Strainer” on page 26.
6.
After cleaning, insert the Interlock Key in the key switch and reset to initial position
7.
Close the sterilizer door and put the door stop block back.
4.6 Validation and Performance Qualification
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Validation and performance qualifications shall be performed on site by the client, in compliance with regional standards and regulations.
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Getinge MAH (Market Authorization Holder) provides services for validation, for example the Commissioning service which contains qualifications that conforms to EN ISO 17665 and EN 285.
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5
Troubleshooting | 169
Troubleshooting This chapter contains a complete reference of alarms with hints on troubleshooting or repair for each alarm. It also contain generic information for checking media and leaks, which might cause problems. If there is a problem with the performance of the sterilizer, it is necessary to check both the sterilizer and the supplied media, especially the water quality and the steam quality. NOTE CHECK GROUNDING POINTS Proper grounding is essential for safety when dealing with electrical circuits and devices. Check grounding points and compare to the electrical diagram after installing or changing electrical components.
5.1 Water Quality The hardness of the water is caused by minerals like calcium and magnesium. It is measured in German degrees - °dH. Water with a value above 10 °dH is regarded as hard. Hard water increases the risk of limescale and other deposits in steam generators and pipes. Soft water has a hardness value of below 4 °dH. To optimize the function of the sterilizer, soft water is preferred. If the feedwater is hard, it can be softened with an ion exchange process. An ion exchange filter replaces the calcium ions with sodium ions, thereby lowering the hardness value in the water. Common and natural substances in ground water are iron, manganese, magnesium and fluorine. High values of iron and manganese can cause black and reddish brown coating on metal surfaces. Magnesium can cause a bluish coating. Cleaning of ground water is normally done in five steps:
Aeration – high values of carbon oxide and other gases are removed.
Filtration - coarse particles are filtered in sand beds.
Softener – calcium ions are replaced with sodium ions, making the water softer.
pH adjustment – calcium and sodium oxide are added for fine adjustment of the pH value.
Disinfection – addition of chloride or ozone are added before use in the household.
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For use in health care and for industrial use, a high water quality is required. If a high water quality is used, the sterilization result is optimized and there is less need for preventive maintenance of the equipment.
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5.1.1 Feedwater Quality Feedwater quality can affect the efficiency of the sterilization process. A low feedwater quality can cause problems with the operation of the steam generator. The water contains small amounts of impurities, and these are concentrated in the steam generator. These impurities will eventually cause a deposit of limescale on the inside of the steam generator and this deposit will affect the operation of the steam generator, and - if not cleaned - it can cause failure in the sterilization process.
5.2 Alarms and Messages 5.2.1 General The sterilizer control system generates messages when an action is required or a malfunction occurs. The messages are grouped into categories:
Process Information
Process Information
Alarms
Warnings
Information texts
Start Conditions
Guidance
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.
Alarms
Alarm conditions are indicated by a red screen and a pulsing alarm tone. If an alarm occurs during a running process, the process is aborted and the process will be reported as failed. The alarms can be muted right away, but for confirming the alarm, the problem that generated the alarm must be fixed first. All alarms are listed in the Alarms and Message History page on the control panel.
Warnings
Warnings iare indicated by a yellow screen. Warnign reports less severe problems then alarms, the sterilizer is usually able to complete the process if a warning occurs. Warnings can be confirmed right away. All warnings are listed in the Alarms and Message History page on the control panel.
Information texts alert the daily user to pertinent conditions. Messages appear on the display and are highlighted in blue. The message clears automatically when the condition is corrected.
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Information Texts
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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 at the bottom of the program view, next to the start button. By tapping the Information button a message with more information and a proposed solution is displayed.
Guidance
By tapping the Guide button (when present) a view with more information and guidance is displayed.
5.2.2 System Alarms and Messages This section is a reference to be used when alarms and messages are set on the sterilizer. Alarms or messages marked with * in the table are related to sterilizer options and configurations that may not exist at each GSS67H unit.
No.
Fault description
Cause
Action
21001
CPU Power failure
The power to the control system is interrupted for more than 10 seconds during the process.
Check the main power, fuses and circuit breakers.
The control system gets no record of what happened during power failure.
21003
Faulty I/O card
An I/O card reports a failure, or the CPU detects a Check the communication bus cables and circuit communication failure with an I/O module. The boards. Replace if necessary. control system is not able to control or supervise the machine.
21004
Emergency stop
The emergency stop button is activated.
Check that no emergency situation exists and release the emergency stop button. If no emergency button has been activated, check the electrical circuits. Release the emergency stop button.
21007
Door seal leak
The control system detected a leak in the door seal. Doors must be sealed during the process and a leak can affect the sterilization result.
Check for leakage on the door seal tubing to and from the gasket. Check the door gasket condition. Check for leaks in the chamber. Check the pressure switch set point and function.
Vacuum pump failure
No return signal within 15 seconds from the motor Check the feedback signal from the vacuum pump contactor when the pump has been activated. Not contactor's digital output. possible to evacuate chamber or retract door gasket.
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21008
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21009
Low sterilization temperature
Troubleshooting | 172
The temperature registered by the controlling temperature sensor is below the sterilization temperature. The alarm is enabled after the first 15 seconds of the sterilization phase.
Check the media steam to the chamber. Check the sterilizer's drain system. Verify the temperature sensor calibration. Check the temperature sensor position.
21010
21011
High sterilization temperature
Low chamber pressure
The temperature registered by the controlling temperature sensor is above the sterilization temperature by more than 2.5°C. The alarm is enabled after the first 15 seconds of the sterilization phase to protect heat sensitive goods and detect overheated steam, since it can affect the sterilization result.
Check the incoming steam valve.
The pressure registered by the chamber pressure sensor is lower than the calculated saturated steam pressure for the sterilization temperature. This indicates superheated steam, sensor problems, or poor calibration and will affect the sterilization result.
Check the steam quality, the steam might be superheated.
Verify the temperature sensor calibration. Check the temperature sensor position.
Check calibration for temperature and pressure. Check the drain system to make sure it is not blocked or clogged.
The alarm is enabled after the first 15 seconds in the sterilization phase.
21012
21013
High chamber pressure
High jacket temperature
The pressure registered by the chamber pressure sensor is higher than calculated saturated steam pressure for sterilization temperature +3°C (or + 4°C for effluent cycles). This indicates air or other non-condensable gases in the chamber, sensor problems, or poor calibration and this will affect the sterilization result. The alarm is enabled during the sterilization phase.
Check calibration of the temperature and pressure sensors.
The jacket temperature sensor is above the sterilization temperature by more than 4°C.
Check the valve for steam to jacket.
The alarm is enabled when jacket heating is activated during the process.
Check for leaks in the chamber. Check for causes to non-condensable gases.
Check the temperature sensor position. Verify the temperature sensor calibration.
20114
Leak rate test failure
Chamber pressure raises more than 0.0013 bar (0.019 psi) per minute during the leak test. A leak can affect the result of the sterilization cycle. The alarm is enabled during the leak test cycle.
Check for leaks in the chamber.
21015
Massive leak test failure
Chamber pressure is greater than 0.5 bar(a) (7.25 psia) after pressure stabilization. A leak can affect the result of a sterilization cycle. The alarm is enabled during the leak test cycle.
Check for leaks in to the chamber.
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The load gets heated by the jacket instead of the steam in the chamber. Also risk for overheating the steam in the chamber.
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21019*
Steam generator water level
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Low water level in the steam generator for more than 50 seconds. There is a risk of overheating the elements.
Check the water supply to the steam generator. Check the feed water pump function and the electrical circuit. Check the related signals and I/O modules.
21020*
Steam generator fill time
Water filling takes more than 4 minutes from low to normal level. This indicates a fault in the water supply or in the normal level switch, which might cause overfilling of the steam generator.
Check the water level through the sight glass. Check the water supply to the steam generator. Check the feed water pump function and the electrical circuit. Check the related signals and I/O modules.
21023*
Steam generator interlock
The steam generator interlock circuit indicates a fault that persists for more than 50 seconds. Heating is interlocked, no steam is produced.
Check the components of the interlock circuit.
21024*
Feed water pump failure
No return signal from motor controller when pump is activated. Not possible to fill water, evacuate chamber, or retract door seal
Check the motor protection.
Air detector failure
The air detector's sensor temperature is lower than expected. This indicates air or other noncondensable gases in the chamber which affects sterilization results.
Check for leaks.
The water level in the sealant water tank for the vacuum pump is not reached within 5 minutes.
Check the incoming water supply for the vacuum pump.
21027*
21040
No service water
Check the contactors for the feed water pump.
Check for air or other non-condensable gases in the steam.
Check the level switch and the signal to the control system.
21041
Air supply failure
A pressure switch indicates a low incoming air pressure for more than 15 seconds of the process. The machine cannot run without air media.
Call the facility manager to check that the air supply to the sterilizer is switched on. Check the incoming air supply. Check the pressure switch set point and function.
Water supply failure
A pressure or level switch indicates low incoming water pressure/level for more than 15 seconds during the process. The machine cannot run without water media.
Call the facility manager to check that the water supply to the sterilizer is switched on. Check the incoming water supply. Check the pressure switch set point and function.
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21042*
Service Manual
21043*
Steam supply failure
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A pressure switch indicate low incoming steam pressure for more than 15 seconds of the process. The machine cannot run without steam media.
Call the facility manager to check that the steam supply to the sterilizer is switched on. Check the incoming steam supply. Check the pressure switch set point and function.
21050
Door seal timeout
The door seal pressure switch was not activated within a specified time.
Check for leakage on door gasket, incoming piping system and drain. Check door gasket condition.
21051
21052
Pressure timeout
Vacuum timeout
The chamber pressure did not reach the high pressure limit within a specified time.
Check incoming supply media.
The chamber pressure has not reached the low pressure limit within a specified time.
Check the vacuum pump system.
Check valve functionality.
Check for leaks in the vacuum system. Check the cooling water supply. Check the temperature on incoming cooling water. Check the vacuum pump electrical function. Check the valves involved in vacuum phase.
21053
Heat timeout
The temperature sensors did not reach the temperature limit within a specified time.
Check the incoming media steam supply. Check the valve function for steam inlet to chamber or filter. Check the steam generator.
21054
Steriization timeout
The temperature sensors indicated a temperature below the sterilization temperature for more than a specified time.
Check incoming steam media supply. Check the temperature calibration. Check the temperature sensors. Check for blocking or clogging in the drain system.
21055*
Cooling timeout
The load temperature sensors did not reach the cooling temperature within a specified time.
Check for blocking or clogging in the drain system. Check for steam supply leakage into chamber.
Vacuum warning
The chamber pressure did not reach the low pressure limit within a specified time.
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The warning may be displayed at start up when the sterilizer has been off over night during hot weather and is not critical in temporary occurrence. Check the cooling water temperature first, warm cooling will impair performance. Secondly check for a faulty or worn vacuum system. 67H132E
21056
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21060
Door interlock
Faulty door switch, faulty wiring, or loose/missing door switch/latch.
21061
Door seal interlock
Faulty door pressure switch, faulty wiring, or blocked/kinked pressure line.
21062
Chamber pressure interlock
Faulty chamber pressure switch, faulty wiring, or blocked/kinked pressure line.
21063*
Load temperature interlock
Faulty temperature sensor, faulty wiring, or interlock relay.
21069
Supervisor error
Supervisor communication problem. Independent supervisor not possible.
21070
AI-Failure - Chamber The control system detected a faulty sensor or a pressure sensor value out of range during the process. The control system is not able to control or monitor the process with faulty sensors.
Check the sensor, wiring and I/O Module, see Chapter 3.11.1 “Chamber Pressure Sensor PE05” on page 83. For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90. For faults during an LTSF process, special safety precautions must be made if replacing the sensor, see the .
21071
AI-Failure – Steam pressure
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor, wiring and I/O Module.
For sterilizers with integral steam The control system is not able to control the boiler generator,see Chapter 3.11.2 “Boiler Pressure (if present) and monitor the steam pressure / PE06” on page 85 . calculate media consumption with a faulty For sterilizers with central steam, see the . pressure sensor. For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
AI-Failure - Chamber The control system detected a faulty sensor or a temp sensor value out of range during the process. The control system is not able to control or monitor the process with faulty sensors.
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Check the sensor, wiring and I/O Module,see Chapter 3.11.4 “Chamber Temperature Sensor TE00” on page 86. For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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21072
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21073
AI-Failure - Jacket temp
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The control system detected a faulty sensor or a sensor value out of range during the process. The control system is not able to control or monitor the jacket temperature with a faulty sensor.
21074
AI-Failure Condenser temp
The control system detected a faulty sensor or a sensor value out of range during the process. The control system is not able to control the cooling with a faulty sensor.
21075
AI-Failure – Drain jacket temp
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor, wiring and I/O Module, see Chapter 3.11.5 “Jacket Temperature Sensor TE01” on page 87 . For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Check the sensor, wiring and I/O Module,see Chapter 3.11.6 “Condenser Temperature Sensor TE04” on page 88. For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Check the sensor, wiring and I/O Module,see Chapter 3.11.7 “Drain Jacket Temperature Sensor TE07” on page 89.
21076
21077
21078
21080
AI-Failure - Load temp
AI-Failure – Air detector temp
AI-Failure – Serv. liquid temp
AI-Failure – Flow meter
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor, wiring and I/O Module, see the .
The control system is not able to control or monitor liquid sterilization and cooling (of sealed containers) with a faulty load sensor.
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor, wiring and I/O Module, see the .
The control system is not able to monitor the air detector and control the process with a faulty sensor.
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor, wiring and I/O Module, see the .
The control system is not able to control or monitor the vacuum system service liquid temperature with faulty sensor.
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor FE08, its wiring and the I/O Module K64.
The control system is not able to monitor the water flow or calculate the water consumption with a faulty flow sensor.
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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The control system is not able to control the jacket condensate drain with a faulty sensor. For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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21081
21102*
AI-Failure – Flow meter remote
Super.AI-Fail.Chamber pressure
Troubleshooting | 177
The control system detected a faulty sensor or a sensor value out of range during the process.
Check the sensor FE11, its wiring and the I/O Module K64.
The control system is not able to monitor the water flow or calculate the water consumption at the remote vacuum system with a faulty flow sensor.
For information about troubleshooting faulty signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Supervisor I/O module reports faulty sensor or value out of range.
Check the sensor, wiring and I/O Module, see Chapter 3.11.3 “Supervisor Chamber Pressure Sensor PE29” on page 85.
The Supervisor will not be able to close the interlock chain and enable door opening. The For information about troubleshooting signals, independent chamber pressure monitoring will not see Chapter 3.11.9 “Troubleshooting Sensors and be operative. AI Signals” on page 90.
21103*
Super.AI-Fail.Chamb temp
Supervisor I/O module reports faulty sensor or value out of range. The independent chamber temperature monitoring performed by the Supervisor will be inoperative.
21104*
21102*
Super.AI-Fail.-Load temp
Super.AI-Fail.Chamber pressure
Check the sensor, wiring and I/O Module, see Chapter 3.11.8 “Supervisor Chamber Temperature Sensor TE24” on page 89. For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Supervisor I/O module reports faulty sensor or value out of range.
Check the sensor, wiring and I/O Module, see the .
The Supervisor will not be able to close the interlock chain and enable door opening subsequent to a liquid program for sealed containers . The independent load temperature monitoring will be inoperative.
For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Supervisor I/O module reports faulty sensor or value out of range.
Check the sensor, wiring and I/O Module, see Chapter 3.11.3 “Supervisor Chamber Pressure Sensor PE29” on page 85.
The Supervisor will not be able to close the interlock chain and enable door opening. The For information about troubleshooting signals, independent chamber pressure monitoring will not see Chapter 3.11.9 “Troubleshooting Sensors and be operative. AI Signals” on page 90.
Super.AI-Fail.Chamb temp
Supervisor I/O module reports faulty sensor or value out of range. The independent chamber temperature monitoring performed by the Supervisor will be inoperative.
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Check the sensor, wiring and I/O Module, see Chapter 3.11.8 “Supervisor Chamber Temperature Sensor TE24” on page 89. For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
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21103*
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21104*
Super.AI-Fail.-Load temp
Troubleshooting | 178
Supervisor I/O module reports faulty sensor or value out of range.
Check the sensor, wiring and I/O Module, see the .
The Supervisor will not be able to close the interlock chain and enable door opening subsequent to a liquid program for sealed containers . The independent load temperature monitoring will be inoperative.
For information about troubleshooting signals, see Chapter 3.11.9 “Troubleshooting Sensors and AI Signals” on page 90.
Check if any I/O cards are broken or put in wrong place.
21150
I/O configuration fault
A faulty I/O configuration is detected by the system.
21151*
Supervisor configuration fault
A faulty configuration of the supervisor is detected There is a configuration problem on the machine. by the system. Contact the second line support to get support.
21152*
Steam gen. contactors
The contactors for the heat elements in the steam generator are not switching.
Check the contactors, wiring and output from control system.
21153
I/O read/write fault
I/O read or write routine reported an fault.
Check if any I/O cards are broken or put in wrong place.
21154
Faulty I/O calibration The calibration data file is corrupted or missing. data
Check that there is calibration data for all analog inputs.
21155*
Temp sensor deviation
The readings from the supervisor sensor and the control sensor deviates too much during a part of the process where thy are supposed to coincide.
Supervisor detected too large temperature deviation between temperature sensors.
Check the sensors and replace and/or calibrate if necessary:
Steam processes:TE00 –TE24
LTSF processes:TE05 –TE25
For sterilizers with load monitoring, also check: TE02 –TE25
21156*
Sterilization deviation
The supervisor detects faulty sterilization temperature or short sterilization time.
Check for faulty chamber/drain PT-100 sensor calibration and/or a faulty I/O-board.
21157*
= Steam generator pressure
Steam generator not working properly. Faulty heating element.
Steam generator heating constantly activated more than 2 minutes when the steam consumption is supposed to be low.
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Check for broken or worn heating elements, faulty power contactors or interrupted element wiring.
Troubleshooting | 179
21158*
Steam generator level sensor
The level switches indicate high and low water level at the same time.
Check the two level switches. Controlling the water level in the sight glass might give an indication on witch component that is faulty.
21159*
Super. Faulty I/O card
Supervisor reports I/O card failure.
Check the Supervisor communication bus cables and circuit boards. Replace if necessary.
21160*
Super. Def.Config load
Supervisor has loaded the default configuration.
The error message is only expected during download of Supervisor software. Check for a correct installation height (above sea level) setting. Contact second line support if the error persists.
21161*
Super. Log memory error
Supervisor process log memory invalid.
This error indicates that a portion of the process report is missing. The error is expected during power failure.
25003
Maintenance
A preset service interval has occurred, and Contact a local service technician. maintenance is requested to ensure safe operation of the sterilizer. It is still possible to start a new cycle without action.
25101
Door not closed
Doors must be closed to run a cycle.
25102
Door seal pressure
Door seal should not be pressurized in standby mode for Non barrier doors. Door seal must be pressurized in standby mode for Barrier doors.
25103
Active alarm
All alarms must be acknowledged before starting a new cycle.
25104
Door key switch
The door key switch is activated, and the sterilizer is in maintenance mode.
25105*
Low steam media
A low pressure on the incoming steam media is detected in the standby phase.
25106
Low air media
A low pressure on the incoming air media is detected in the standby phase.
25107*
Low water media
A low pressure or level on the incoming water media is detected in the standby phase.
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Check that all doors are closed properly.
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25109*
Steam generator
The steam generator has not reached working pressure, or is in test mode.
25110
Low jacket temperature
The jacket temperature is lower than jacket controller setpoint -3 °C (5.4 °F).
25111
High jacket temperature
The jacket temperature is higher than jacket controller setpoint +3 °C (5.4 °F).
25113*
F0 value too low
The combination of sterile temperature and sterile time results in a too low F0 value.
25114
Documentation not ready
Printout of cycle report is interrupted if new cycle is started before the printout is ready.
25115
No valid program
No valid program is selected or there is a corrupted program parameter file.No valid program is selected or there is a corrupted program parameter file.
Select the appropriate program
25118
Machine stopped
The machine is in stop mode. After an alarm the machine must be restarted.
On the touchscreen, open the Menu. Tap Process Control and then tap Continue.
25119
Interlock fault
A fault in the safety interlocks is detected. The machine needs service of the redundant safety interlocks.
Check the Alarm & Messages/Alarm & Messages History to see the reason for the interlock.
25120
Hibernation
The machine is in hibernation to save energy. The Wait for wake-up time to elapse or tap Wake up machine waits for wake-up time. on the touchscreen to terminate the Hibernation.
25121
Run leak test
A leak has been detected. The sterilization can´t be guaranteed if there is a leak.
Find the leak and repair it. Run a successful leak rate test.
25122*
Jacket heat off
The jacket heating is turned off. For most programs the jacket must be heated before started.
Open and close the door.
25123*
No supervisor connection
There is no communication with the supervisor.
Check the Supervisor/Control system intercommunication bus cables and the circuit boards. Replace if necessary.
Select a combination with longer sterile time and/ or higher sterilization temperature to get a higher F0 that is expected to achieve a sterile result.
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Check the elements, wiring, and the boiler interlock circuits (High temperature, level switch and pressure) .
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25124
Power lost
There is no power to the machine.
The power has been interrupted for less than 10 seconds. Check the power supply to the machine.
25131
Manual outputs
One or more output is in manual mode. Output in manual mode affects the cycle.
Check for manually activated outputs and set to automatic mode.
25200
Step manually
Faulty pressure or temperature sensor makes it necessary to manually advance process. Cycle is halted and waits for technician to manually step sequence forward.
Step sequence forward to continue the cycle.
25201
Equalize and step manually
Faulty pressure sensor makes it necessary for Step sequence forward to continue the cycle. manually equalization of chamber pressure. Cycle Equalize chamber pressure manually. is halted and waits for technician to manually equalize chamber pressure. Change the faulty sensor.
25211*
Autostart start-up
The warm up cycle has been started. The sterilizer is waiting for the auto startup time.
Wait for auto start time to elapse or tap Abort on the touchscreen to terminate auto start.
25212
Door not unlocked
The door locking mechanism is stuck when trying to open the door.
Check the door locking mechanism.
93000
Config. File: Read Error
Configuration file is either corrupt or cannot be opened.
Restore the system using backup files.
93001
System Time Monitor Err
Deviations in time measurement between Real Time Clock and CPU clock.
Change the panel.
93002
Data Integry Error
Software error detected.
Contact the second line support to report the error.
93003
Internal System Error
Internal system error detected.
Change the panel.
93004
Program file: CRC Error
Data fault.
Contact the second line support to report the error.
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Change the faulty sensor.
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93005
File System: Mem Low
memory fault.
Clean the following directories in the file system: F:\Platform\ExtClient\Temp (all files) F:\Platform \Logs (all files) F:\Platform\Reports\Repository: first copy all pdf-files to PC or USB drive and then delete files older than 7 days. Deliver a copy of the reports to the site administrator F:\Platform \Temp (all files) F:\Platform\Uploads (all files)
93006
File System: Mem Full
memory fault.
Clean the following directories in the file system: F:\Platform\ExtClient\Temp (all files) F:\Platform \Logs (all files) F:\Platform\Reports\Repository:
93100
Users File: Read Error
File with list of users is either corrupt or cannot be opened.
Restore the system using backup files.
93101
Rights File: Read Error
File with list of user rights is either corrupt or cannot be opened.
Restore the system using backup files.
93102
X20Config file: Read Err
File with X20 configurations is either corrupt or cannot be opened.
Restore the system using backup files.
93103
License File: Read Error
he Options License file is either corrupt or cannot be opened.
Restore the system using backup files.
93104
License File: Error
Warning message. The serial number of the panel Set up new license file in the Service web and the serial number in the file of licenses does interface. not match.
93200
Process Report Error
Warning message. Failed to print Process report.
Check the network connection to printer. Check cable between fascia panel and printer. Change the printer. Check if the USB memory stick is full. Check if the USB memory stick is formatted according to FAT32. Change the USB memory stick. Change the USB hub if one is used.
93201
Netw. Printer: Conn Err
Warning message. Failed to connect to network printer.
Contact local IT-support to check the network connection.
93202
Fascia Printer: Conn Err
Warning message. Failed to connect to the network printer.
Check the cable between panel and printer.
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Change the printer.
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93203
USB Storage: Conn Err
Troubleshooting | 183
Warning message. Failed to detect the USB memory stick.
Check if the USB memory stick is formatted according to FAT32. Change the USB memory stick. Change the USB hub if one is used.
93204
Netw. Storage: Conn Warning message. Failed to connect to the server Contact local IT-support to check the network Err for network storage. connection.
93206
USB Storage: Write Err
Warning message. Failed to write to USB memory Check if the USB memory stick is formatted stick. according to FAT32. Change the USB memory stick. Change the USB hub if one is used.
93207
USB Storage: Mem Full
Warning message. Failed to write to USB memory Change the USB memory stick. The report has stick. Memory is full. been archived and will be saved on the new USB memory stick.
93208
USB Storage: Mem Low
Information message. Memory on the USB memory stick is nearly full.
Change the USB memory stick.
93209
Netw. Storage Write Err
Information message. Failed to send report to server for network storage.
Check the network storage configuration.
93210
Fascia Printer: Write Err
Warning message. Failed to print.
Check cable between panel and printer.
Fascia Printer: No paper
Warning message. No paper in the printer or the lid not properly closed.
Check the printer paper roll, replace if needed.
93212
Netw. Printer: Write Err
Warning message. Failed to send report to the network printer.
Check the printer configuration.
93214
Netw Printer: Report OK
Information message. Confirmation that the archived report is successfully sent to network printer.
No action required.
93215
Fascia Printer: Report OK
Information message. Confirmation that the archived report is successfully sent to fascia printer.
No action required.
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Ensure that the lid on printer is closed.
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93211
Change the printer.
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93216
USB Storage: Report Information message. Confirmation that the OK archived report is successfully sent to USB memory stick.
No action required.
93217
Netw. Storage: Report OK
Confirmation that the archived report is successfully sent to network storage.
No action required.
93300
RFID Reader: Conn Err
Warning message. Failed to connect to the RFID reader via USB.
Check connection between the panel and the RFID reader. Change the RFID reader.
5.3 Detecting Leaks This chapter contains a description on how to detect leakage in the sterilizer or the supply system. To avoid bodily injury, contamination, pressure failure or malfunction, detecting leakage in washers and junctions is essential. The service technician shall perform a leak test at every service occasion and generic components like valves and strainers shall be serviced according to the maintenance plan.
Searching for Steam Leaks
To perform a steam leak search you need a lighted inspection mirror. Inspect all connectors, if the mirror fogs up there is a steam leak. Check the washer, replace if damaged or broken.
Searching for Air Leaks
To perform an air leak search you need a stopwatch, with an error of not more than ± 0.5 s over a period of 15 min. Stabilize the temperature of the sterilizer chamber by carrying out one of the following:
if the pressure vessel incorporates a heated jacket, carry out a sterilization program with the sterilizer chamber empty.
if the pressure vessel does not incorporate a heated jacket, ensure that the temperature of the sterilizer chamber is not more than 20 °C from ambient.
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With the temperature stabilized and the sterilizer chamber empty except for fixed furniture and necessary monitoring sensors, start the test program. When the pressure in the sterilizer chamber is 7 kPa or below, close all the valves connected to the sterilizer chamber and stop the vacuum pump. Observe and record the time (t1) and the pressure (p1). Wait at least 300 s and not more than 600 s to allow evaporation of condensation in the chamber and then observe and record the pressure (p2) in the sterilizer chamber and the time (t2). After a further (600 ± 10) s, again observe and record the pressure (p3) and the time (t3).
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NOTE
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The sterilizer can be fitted with a test program for air leakage which will carry out this procedure automatically and display the air leakage in kilopascals per minute (millibar per minute).
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Process Overrides | 186
Process Overrides
6.1 Manual Interventions in the Process When faults occur during a process because of interruptions in the supply of media or component faults, the process may, after an alarm has been triggered, get stuck in a phase from which the control equipment cannot proceed. Various options are then open to the user. Options that do not involve a hazard to the user are described in the “Alarms” section of the User Manual. If the daily users options for action are not possible or do not solve the problem, a trained technician must be called to advance the program manually. WARNING BYPASSING SAFETY OPTIONS With the stepping option, a technician can under certain circumstances manually bypass built-in safety conditions.
6.2 Stepping in Programs A program can be stepped to manually jump one sub phase forward. The program can be forced to advance even though all programmed conditions for entering the next phase are not fulfilled. Only personnel logged in as Service Technicians are authorized to step in programs.
0000007653
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Figure 92: “Main menu è Process Control ”
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1.
On the Program Select menu, tap Menu to open the Process Control view.
2.
Tap Step Program until desired sub phase is reached. The current phase and the sub phase are always displayed at the top.
Stepping of the program should take place while the sterilizer is still in the alarm phase. During stepping, all functions are controlled by the automatic control equipment, so that hazardous situations cannot normally occur. With manual control, however, the program is stepped from one program phase to another without meeting the temperature, time, or pressure conditions of the process. For safety reasons, the ability to step past critical process conditions is blocked. This applies, among other things, to certain pressure, temperature, and level conditions, except when there is a fault in an analog sensor.
6.3 Power Failure Alarm with Door Open
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If a sterilizer door is partially or fully open, an alarm will be generated for safety reasons after a power failure. The doors must therefore always be closed when the control power supply is turned off.
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Validation | 188
Validation
Type Test
When shipped from the factory, the machine is type tested and approved according to national regulations. Type test records for the factory programs and a technical file is stored by the legal manufacturer. Among other data, the technical file contain the program combination on the machine and the program descriptions.
Validation
The sterilizer's performance must be validated to loads or product families typical for the client's intended use before it is put into service. Such a validation consists of:
Qualification
Description
Installation Qualification (IQ)
Tests for establishing that the equipment has been provided and installed according to its specifications.
Operational Qualification (OQ)
Tests for establishing that the equipment operates within predefined limits when used according to its operational procedures.
Performance Qualification (PQ)
Tests for establishing that the equipment performs according to a predetermined performance criteria and thereby yields product meeting its specification.
shall include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as specified by the standard EN ISO 17665-1. For sterilizers complying with EN 285 appropriate sterilizer test to be performed in IQ and OQ are found in the EN 285 appendix: "Guidance for installation and operation qualification tests to be included in the instructions for use supplied with the sterilizer". For factory programs results from the type tests may be referenced in the validation if the production load is less of a challenge than the reference load used in the type test. Validating the sterilizer for its intended use is the clients responsibility and shall be performed according to the client's Quality Management System, in cooperation with a local Getinge representative.
EN ISO 17665-1 describes the requirements on the validation. EN 285 appendix: "Guidance for installation and operation qualification tests to be included in the instructions for use supplied with the sterilizer" provides further guidance of the tests to inlcude in the validation for sterilizers that shall comply to EN 285. Additional requirements might be provided by the client.
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Related Standards and Documentation
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Validation | 189
7.1 Modification of Program Parameters at Validation When validating a program for a customer's load configuration it might be necessary to adjust the program to achive and proof a successful result. For factory programs, changes can be made to the posttreatment in order to optimize the drying without voiding the type tests for the program. If the customer's load configuration is less of a sterilizing challenge than the type test loads, then the results from the type tests may be reused in applicable parts of the validation
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If the customer's load configuration provides a greater challenge than the type test loads or if a custom program has been created, more extensive testing may be required to proof a successful performance. For more information, see see Chapter 3.12.16 “Program Management” on page 131.
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Recycling and Scrapping | 190
Recycling and Scrapping This chapter describes how to recycle or scrap the sterilizer and its parts.
Recycling of Metal Components WARNING HEAVY PARTS The doors and chamber are heavy and can cause injury by crushing. 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 succesfully or that the sterilizer has been sanitized in order to eliminate infectous contaminants.
Plastic details are marked with international codes and shall be sorted according to the marking when recycled.
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Recycling Plastic Components
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Index | 191
Index A Access types, parameters . . . . . . . . . . . . . . . . . 138 Add, program button . . . . . . . . . . . . . . . . . . . . . 146 Adjustable, parameter . . . . . . . . . . . . . . . . . . . . 138 Aeration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 AI 00 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 AI 01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 AI 02 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 AI 03 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 AI 04 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 AI 05 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 AI 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 AI 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Air detector bypass, parameter . . . . . . . . . . . . . 143 Air detector test, parameter . . . . . . . . . . . . . . . . 142 Air filter, atmospheric . . . . . . . . . . . . . . . . . . . . . . 81 Air filter, atmospheric, replace . . . . . . . . . . . . . . . 81 Air pulse high level, parameter . . . . . . . . . . . . . 141 Air pulse hold time, parameter . . . . . . . . . . . . . . 142 Air pulse low level, parameter . . . . . . . . . . . . . . 141 Air pulse, parameter . . . . . . . . . . . . . . . . . . . . . 141 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Atmospheric air filter . . . . . . . . . . . . . . . . . . . . . . 81 Atmospheric air filter, replace . . . . . . . . . . . . . . . 81 Atmospheric pressure . . . . . . . . . . . . . . . . . . . . . 18 Authorized personnel only . . . . . . . . . . . . . . . . . . 15
Display settings . . . . . . . . . . . . . . . . . . . . . . . . . 119 Door crush protection . . . . . . . . . . . . . . . . . . . . . 18 Door gasket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Door gasket, replacing . . . . . . . . . . . . . . . . . . . . . 48 Door latch clearance, adjustment . . . . . . . . . . . . 160 Door latch overlap, Adjustment . . . . . . . . . . . . . 160 Door lock, safety checks . . . . . . . . . . . . . . . . . . 159 Door mode, parameter . . . . . . . . . . . . . . . . . . . . 142 Door opening interlock . . . . . . . . . . . . . . . . . . . . . 18 Door pinch protection, safety check . . . . . . . 42, 160 Door seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Door speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Door stop pad . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Doors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Doors control diagram . . . . . . . . . . . . . . . . . . . . . 39 Drain jacket temperature sensor . . . . . . . . . . . . . 89 Drain module, GSS 67H, GSS67F . . . . . . . . . . . . 71
E Electric arc welding . . . . . . . . . . . . . . . . . . . . . . . 15 Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Emergency stop, safety test, door movement . . 160 Emergency stop, safety test, running a process . 161 Ethernet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Export, program configuration file . . . . . . . . . . . 149
F
B B16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52, 53 B17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Backup, programs . . . . . . . . . . . . . . . . . . . . . . . 149 Baseline, program . . . . . . . . . . . . . . . . . . . . . . . 143 Bleeder check valve, GSS 67H, GSS67F . . . . . . 71 Blow down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Boiler pressure sensor . . . . . . . . . . . . . . . . . . . . . 85 Burn hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Buttons, on touch screen . . . . . . . . . . . . . . . . . . 113
C Chamber pressure sensor . . . . . . . . . . . . . . . . . . 83 Chamber temperature sensor . . . . . . . . . . . . . . . 86 Circle view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Cleaning, Steam strainer . . . . . . . . . . . . . . . . . . . 25 Cleaning, Water strainer . . . . . . . . . . . . . . . . 25, 26 Condensate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Condensate drain valve, GSS 67H, GSS67F . . . . 71 Condenser temperature sensor . . . . . . . . . . . . . . 88 Connections, vacuum and cooling . . . . . . . . . . . . 78 Control diagram for the doors . . . . . . . . . . . . . . . 39 Cooling, connections . . . . . . . . . . . . . . . . . . . . . . 78 customization setting, parameter . . . . . . . . . . . . 138
F10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 FCV12, GSS 67H, GSS67F . . . . . . . . . . . . . . . . . 71 FCV12AD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Feed water . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Feedwater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Feedwater pump . . . . . . . . . . . . . . . . . . . . . . 58, 60 Feedwater tank . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Feedwater tank, cleaning . . . . . . . . . . . . . . . . . . . 53 Float valve, steam generator . . . . . . . . . . . . . . . . 56 Front, Open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 FV02 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 FV06 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 FV07 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 FV09 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 FV11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 FV13, GSS 67H, GSS67F . . . . . . . . . . . . . . . . . . 71 FV20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 FV23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 FV48 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
G German degrees . . . . . . . . . . . . . . . . . . . . . . . . 169 Getinge Assured Bowie& Dick Test . . . . . . . . . . 151
H
Date &Time, settings . . . . . . . . . . . . . . . . . . . . . 121 Details view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
H16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Hard water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 Heat Exchanger, placement . . . . . . . . . . . . . . . . . 76 Heating elements in steam generator . . . . . . . . . 56
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Index | 192
I Icons, on touch screen . . . . . . . . . . . . . . . . . . . . 113 Impeller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Information texts . . . . . . . . . . . . . . . . . . . . . . . . 170 Informative, parameter . . . . . . . . . . . . . . . . . . . . 138 Interlock, safety test . . . . . . . . . . . . . . . . . . . . . . 161 Ion exchange process . . . . . . . . . . . . . . . . . . . . 169
J Jacket start interlock, parameter . . . . . . . . . . . . 143 Jacket temperature sensor . . . . . . . . . . . . . . . . . 87 Jacket top, without cooling . . . . . . . . . . . . . . . . . . 70
K K52 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83, 85 K53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86, 87, 88 K94 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
L Language, change . . . . . . . . . . . . . . . . . . . . . . . 120 Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Leaking valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Level switch LS04 in steam generator . . . . . . . . . 55 Limescale . . . . . . . . . . . . . . . . . . . . . . . . . 169, 170 Load data, settings . . . . . . . . . . . . . . . . . . . . . . 121 Load headers, settings . . . . . . . . . . . . . . . . . . . 120 Load with return, parameter . . . . . . . . . . . . . . . . 142 loaders, parameter . . . . . . . . . . . . . . . . . . . . . . . 142 Log in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Log interval, settings . . . . . . . . . . . . . . . . . . . . . 122 Low level protection, safety test . . . . . . . . . . . . . 163 Low Level switch, steam generator . . . . . . . . . . . 56 LS05 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 LS05, safety test . . . . . . . . . . . . . . . . . . . . . . . . 163 LS19, placement . . . . . . . . . . . . . . . . . . . . . . . . . 76 LV16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
P P&I, Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Parameter, access type . . . . . . . . . . . . . . . . . . . 138 parameter, customization setting . . . . . . . . . . . . 138 Parameter, posttreatment . . . . . . . . . . . . . . . . . 141 Parameters, pretreatment . . . . . . . . . . . . . . . . . 138 PCI22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 PE05 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 PE06 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58, 85 PE29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Pilot valve, activate manually . . . . . . . . . . . . . . . . 35 Pinch protection, safety check . . . . . . . . . . . 42, 160 Piston valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Positive pulse high level, parameter . . . . . . . . . 140 Positive pulse low level, parameter . . . . . . . . . . 139 Positive pulse, parameter . . . . . . . . . . . . . . . . . 139 Posttreatment, parameter . . . . . . . . . . . . . . . . . 141 Pressure gauges . . . . . . . . . . . . . . . . . . . . . . . . . 32 Pressure transmitter, steam generator . . . . . . . . . 58 Pressure vessels . . . . . . . . . . . . . . . . . . . . . . . . . 18 Pretreatment, parameters . . . . . . . . . . . . . . . . . 138 Preventive maintenance procedures . . . . . . . . . 151 Printer, log interval settings . . . . . . . . . . . . . . . . 122 Process status . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Processor, supervisor . . . . . . . . . . . . . . . . . . . . 102 Product liability . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Program backup . . . . . . . . . . . . . . . . . . . . . . . . 149 Program baseline . . . . . . . . . . . . . . . . . . . . . . . 143 Program button, add . . . . . . . . . . . . . . . . . . . . . 146 Program button, remove . . . . . . . . . . . . . . . . . . 146 Program configuration file, export . . . . . . . . . . . 149 Program, pename . . . . . . . . . . . . . . . . . . . . . . . 145 Program, step . . . . . . . . . . . . . . . . . . . . . . . . . . 186 Programs, reorder . . . . . . . . . . . . . . . . . . . . . . . 145 Progress view . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Protective plates . . . . . . . . . . . . . . . . . . . . . . . . . 17 PS71 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 PV300, GSS 67H, GSS67F . . . . . . . . . . . . . . . . . 71
R
Media to chamber interlock . . . . . . . . . . . . . . . . . 18 Menu, Log in . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Metering device . . . . . . . . . . . . . . . . . . . . . . . . . 151
R11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Ramp down, parameter . . . . . . . . . . . . . . . . . . . 140 Ramp up, parameter . . . . . . . . . . . . . . . . . . . . . 140 ramped cycle, parameter . . . . . . . . . . . . . . . . . . 140 Remove, program button . . . . . . . . . . . . . . . . . . 146 Rename, program . . . . . . . . . . . . . . . . . . . . . . . 145 Reorder, Programs . . . . . . . . . . . . . . . . . . . . . . 145 Replacing the door gasket . . . . . . . . . . . . . . . . . . 48 Restricted Access . . . . . . . . . . . . . . . . . . . . . . . . 16
N
S
M
N.C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Negative pulse high level, parameter . . . . . . . . . 139 Negative pulse low level, parameter . . . . . . . . . 139 Negative pulse, parameter . . . . . . . . . . . . . . . . . 139
O Overfill protection, safety test . . . . . . . . . . . . . . . 164
Safety Check, door lock . . . . . . . . . . . . . . . . . . . 159 Safety check, door pinch protection . . . . . . . 42, 160 Safety components . . . . . . . . . . . . . . . . . . . . . . . 16 Safety relief valves . . . . . . . . . . . . . . . . . . . . . . . 30 Safety test, emergency stop button, door movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Safety test, emergency stop button, running a process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
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Hidden, parameter . . . . . . . . . . . . . . . . . . . . . . . 138 High temp protection . . . . . . . . . . . . . . . . . . . . . . 57 High temperature protection . . . . . . . . . . . . . . . . 57 High temperature protection, safety test . . . . . . 164 Hot pipes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Hot surface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Humming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
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Index | 193
System, Log in . . . . . . . . . . . . . . . . . . . . . . . . . . 119
T TE00 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 TE01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 TE04 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 TE07 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 89 TE24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Temperature limiter, steam generator . . . . . . . . . 57 Timers, settings . . . . . . . . . . . . . . . . . . . . . . . . . 121 Tools for preventive maintenance . . . . . . . . . . . 151 Touchscreen, brightness settings . . . . . . . . . . . 119 Touchscreen, calibration . . . . . . . . . . . . . . . . . . 119 TS21, safety test . . . . . . . . . . . . . . . . . . . . . . . . 164 Turning fork level switch . . . . . . . . . . . . . . . . . . . 55 Type-testing the sterilizer . . . . . . . . . . . . . . . . . . 188
U Use loaders, parameter . . . . . . . . . . . . . . . . . . . 142
V Vacuum and Cooling system, connections . . . . . 78 Vacuum drying low level, parameter . . . . . . . . . 141 Vacuum drying time, parameter . . . . . . . . . . . . . 141 Vacuum pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Various types of loads . . . . . . . . . . . . . . . . . . . . 188
W W017 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Warning sign . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Warning symbol . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Water hardness . . . . . . . . . . . . . . . . . . . . . . . . . 169 Water softener . . . . . . . . . . . . . . . . . . . . . . . . . . 169 Water strainer, cleaning . . . . . . . . . . . . . . . . . 25, 26 Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
X X09 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Y YV valves, activate manually . . . . . . . . . . . . . . . . 35
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Safety test, high temperature protection TS21 . . 164 Safety test, interlock . . . . . . . . . . . . . . . . . . . . . 161 Safety test, Low level protection LS05 . . . . . . . . 163 Safety test, overfill protection . . . . . . . . . . . . . . . 164 Safety test, steam generator safety relief valve . 163 Safety valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Screensaver, settings . . . . . . . . . . . . . . . . . . . . 119 Sealant water level switch, placement . . . . . . . . . 76 Sealant water tank . . . . . . . . . . . . . . . . . . . . . . . . 76 Service cycle, parameter . . . . . . . . . . . . . . . . . . 142 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Settings, date & time . . . . . . . . . . . . . . . . . . . . . 121 Settings, Display . . . . . . . . . . . . . . . . . . . . . . . . 119 Settings, load data . . . . . . . . . . . . . . . . . . . . . . . 121 Settings, load headers . . . . . . . . . . . . . . . . . . . . 120 Settings, log interval . . . . . . . . . . . . . . . . . . . . . 122 Settings, Timers . . . . . . . . . . . . . . . . . . . . . . . . . 121 Shock hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Soft water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 Sound power level . . . . . . . . . . . . . . . . . . . . . . . . 16 Sound pressure level . . . . . . . . . . . . . . . . . . . . . . 16 Steam generator safety relief valve, safety test . 163 Steam piping bottom . . . . . . . . . . . . . . . . . . . . . . 64 Steam Piping Top . . . . . . . . . . . . . . . . . . . . . . . . 64 Steam pulse high level, parameter . . . . . . . . . . . 141 Steam pulse hold time, parameter . . . . . . . . . . . 141 Steam pulse low level, parameter . . . . . . . . . . . 141 Steam pulse, parameter . . . . . . . . . . . . . . . . . . 141 Steam strainer, Cleaning . . . . . . . . . . . . . . . . . . . 25 Steam trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Steam trap, disassemble . . . . . . . . . . . . . . . . . . . 66 Steam trap, function check . . . . . . . . . . . . . . . . . 66 steam trap, maintenance . . . . . . . . . . . . . . . . . . . 66 Steam trap, renovate . . . . . . . . . . . . . . . . . . . . . . 66 Step program . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 Sterilization temperature, parameter . . . . . . . . . 140 Sterilization time, parameter . . . . . . . . . . . . . . . 140 Strainer, steam, cleaning . . . . . . . . . . . . . . . . . . . 25 Strainer, water, cleaning . . . . . . . . . . . . . . . . 25, 26 Strainers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Supervisor chamber pressure sensor . . . . . . . . . 85 Supervisor chamber temperature sensor . . . . . . . 89 Supervisor check, parameter . . . . . . . . . . . . . . . 143 Supervisor, Processor . . . . . . . . . . . . . . . . . . . . 102 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 13 Symbols, P&I . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Index | 194
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Getinge Infection Control AB P O Box 69, SE-305 05 Getinge, Sweden Phone: +46 10 335 00 00
[email protected] www.getinge.com
Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound management solutions. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences. Maquet specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care.
