User Manual
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Appendix 1 to: T15549 v029
GSS67 SERIES
USER MANUAL
Copyright notice All rights reserved. Any duplication, adaptation or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. © Copyright GETINGE, all rights reserved Subject to technical modification! Due to further development of the product, the figures used and technical specifications given in these instructions may slightly differ from the current state of the product. Manufacturer MAQUET GmbH Kehler Str. 31 76437 Rastatt GERMANY Telephone: +49 7222 932-0 www.getinge.com Information Product ID: 0000002228, ver. Date: 2020.04.28 8.41.59 ORIGINAL INSTRUCTIONS
USER MANUAL
Table of contents | 5
TABLE OF CONTENTS Index of warnings... 8 1
Preface
13 1.1 Contact Information... 15 1.2 Machine Identification... 16 1.3 Machine Identification... 22 1.4 Machine Identification... 23 1.5 Machine Identification... 25 1.6 Machine Identification... 26 1.7 Machine Identification... 27
2
Safety
29 2.1 Product Liability... 29 2.2 Product Liability... 29 2.3 Safety Precautions... 29 2.4 Safety Features... 32 2.4.1 Safety Interlocks... 34 2.5 Mandatory Reporting... 35
3
Introduction
37 3.1 Intended Use - H Model... 37 3.2 Intended Use - F model... 37 3.3 Clinical benefits... 38 3.4 Sterilizer Overview... 39 3.4.1 Built-in Steam Generator... 43 3.4.2 Programs... 44 3.5 Approved Consumables... 48 3.5.1 Packaging Material... 48 3.5.2 Articles for Test Purposes... 49 3.5.3 Additional Consumables... 50 3.6 Disposal of Consumables... 50 3.7 Approved Accessories... 51
Control Panel Layout
55
4.1 Control Side... 55 4.1.1 RFID Reader (Option)... 56 4.1.2 Interlock Key... 56 4.1.3 ON/OFF Switch... 57 4.1.4 USB port (Option)... 57 4.1.5 Emergency Stop... 57 4.1.6 Touch Screen... 58 4.1.7 Pressure Gauges... 59 4.1.8 Buzzer... 60 4.2 Non-Control Side... 61 4.2.1 Touch Screen... 58 4.2.2 RFID Reader (Option)... 56 4.2.3 Pressure Gauges... 59 4.2.4 USB port (Option)... 57
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Table of contents | 6
4.2.5 Emergency Stop... 57 4.3 Printer... 65 4.3.1 Connecting the Printer... 65 4.3.2 Settings Before Using the Printer... 65 4.3.3 Replacing the Paper Roll... 66 5
The Control System
68
5.1 Introduction... 68 5.1.1 Supervisor... 68 5.1.2 Touchscreen Layout... 69 5.1.3 Buttons... 70 5.1.4 Pop-up Windows... 74 5.1.5 Input Windows... 74 5.2 The Access Management System... 75 5.3 Menus... 81 5.3.1 The Settings Menu... 82 5.3.2 The Documentation Menu... 87 5.3.3 Alarms and Messages Menu... 88 5.3.4 The System Menu... 89 5.4 Select Program View... 99 5.5 Process Views... 102 6
Startup
7
Operation
104 106 7.1 Introduction... 107 7.1.1 General Advice Concerning Formaldehyde... 108 7.2 Packaging... 109 7.2.1 Packaging Material... 110 7.2.2 Packaging Technique... 112 7.3 Loading the Carrier ... 120 7.4 Sterilization... 121 7.4.1 Preparing for a Low Temperature Formaldehyde Sterilization... 121 7.4.2 Before Running an Infectious Load... 122 7.4.3 Selecting a Sterilizing Program... 122 7.4.4 Loading the Sterilizer... 125 7.4.5 Starting a Sterilization... 126 7.4.6 Viewing the Process Status... 129 7.4.7 Aborting a Program... 130 7.4.8 Completing the Cycle and Unload... 131 7.4.9 Checking the Process Report... 134 7.5 Handle Alarms... 140 7.5.1 Respond to Alarm During Standby... 140 7.5.2 Responding to an Alarm During a Running Process... 141 7.6 Emergencies... 144 7.7 Log In & Log Out... 146
Alarms and Messages
148
8.1 General... 148
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8.2 System Alarms and Messages... 149 8.3 System Alarms and Messages... 160 8.4 System Alarms and Messages... 170 8.5 System Alarms and Messages... 183 9
Cleaning and Caring
195
9.1 Daily Care... 195 9.2 Weekly Care... 196 9.3 Monthly Care... 197 9.4 Cleaning Overview... 197 9.4.1 Cleaning the Control Panel Surface... 198 9.4.2 Cleaning the Touchscreen... 198 9.4.3 Cleaning the Chamber... 198 9.4.4 Cleaning the Loading Equipment... 199 9.5 Test and Maintenance Programs... 200 9.5.1 Leak Rate Test... 200 9.5.2 Leak and Flow Test... 200 9.5.3 Bowie Dick... 202 9.5.4 Sterilizer Start Up... 202 9.5.5 Hollow Load Test... 203 9.5.6 Air Detector Test Programs... 203 9.5.7 Manual Leak Rate Test... 203 9.5.8 Cleaning program to remove formaldehyde residues... 203 10
Shutdown
204
11
Program Combination
207
11.1 The Sterilization Process... 207 11.1.1 Steam Sterilization... 207 11.1.2 Formaldehyde Sterilization... 209 11.2 Parameter Information... 211 11.3 Programs... 211 12
Recycling and Scrapping
221
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Index... 222
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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 CHEMICAL HAZARD Formaldehyde is toxic by inhalation, in contact with skin and if swallowed. It can cause serious damage to eyes and skin. Before using the product, read the Material Safety Data Sheet (MSDS) for handling precautions and first aid information.
WARNING RISK OF INJURY Use Getinge approved accessories only. See the section Approved Accessories.
WARNING RISK OF INJURY A reading in the red area of a pressure gauge indicates a dangerous pressure.
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If the reading on the pressure gauge is in the red area, leave the area immediately and contact a local service technician.
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Index of warnings | 9
WARNING EXPLOSION HAZARD Only process liquids with programs intended for the type of container used.
Procesing liquids in closed containers with improper programs may cause explosions.
Processing liquids in open or vented containers with improper programs may cause explosions or burns.
WARNING EXPLOSION HAZARD Processing of liquids with improper programs may cause explosions or burns. Liquids in open or vented containers shall only be processed with programs intended for open liquids. Liquids in closed containers must not be processed in this sterilizer.
WARNING EXPLOSION HAZARD Liquids must not be processed in this sterilizer. Processing of liquids with improper programs may cause explosions or burns.
WARNING RISK OF INFECTION Textile packages absorbs the formaldehyde and may lead to non-sterile goods and risk of infection. Textile packages must not be processed with LTSF programs.
WARNING RISK OF INFECTION Do not process biohazardous waste in the sterilizer.
WARNING RISK OF INFECTION Unclean goods may lead to non sterile goods and risk of infection. The goods must be cleaned before being sterilized.
WARNING RISK OF INJURY
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Water leakage may cause a conductive path from live electrical parts.
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Index of warnings | 10
WARNING Fire Hazard The heat in the sterilizer might ignite flammable and explosive materials. Flammable and explosive materials must not be processed in this sterilizer.
WARNING FIRE HAZARD Goods containing material with an self-ignition temperature lower than 150 °C (302 °F) may ignite due to heat and excessive drying. Do not keep such goods in a heated closed sterilizer prior to, or after, the sterilization.
WARNING CHEMICAL HAZARD The formaldehyde bottle may break if dropped. Formaldehyde is toxic by inhalation, in contact with skin and if swallowed. Handle the formaldehyde bottle with care. In the event of an accident evacuate the personnel to a safe area and take precautionary actions to avoid exposure of formaldehyde, see the Material Safety Data Sheet (MSDS).
WARNING RISK OF INFECTION Use of formaldehyde not according to Getinge's specifications may lead to non-sterile goods and risk of infection. Use only 500 ml Getinge nonreusable formaldehyde bottles (Getinge item number 60144490-70).
WARNING RISK OF INFECTION Bad quality of the formaldehyde will lead to non sterile load and risk of infection. Before using the formaldehyde, check that the formaldehyde has not crystallized or has sediment and that it is free of foreign objects and discoloration.
WARNING Risk of Injury The Sterilizer's door is heavy and may be hot. Keep hands and fingers away from moving doors. To stop a moving door, press the emergency stop button.
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To change the direction of a moving door, tap the Open Door or Close Door button on the touch screen.
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Index of warnings | 11
WARNING BURN HAZARD The door and the chamber can be hot and may cause burns. Be aware of hot surfaces inside the chamber when the door is open.
WARNING Resterilization Precautions Before starting a new sterilization after a an incomplete one, make sure that the goods and the packaging material are intended for repeated sterilizations. If necessary, prepare or repackage the goods before restarting the sterilization. Consult supervisory personnel, or the instructions for use for the goods and packaging material for guidance.
WARNING BURN HAZARD The goods may be very hot immediately after unloading. Allow the goods to cool down or wear safety gloves when handling the goods.
WARNING CHEMICAL HAZARD There is a risk of formaldehyde gas coming out from the sterilizer chamber, if a door is manually opened after a stop in an LTSF process. Contact authorized service personnel to remedy the fault condition and end the program. Never attempt to open the door manually or in any other way bypass the sterilizer's security system.
WARNING Risk of Injury When Turning Off During a Process Turning off the power to the sterilizer during a running process may affect the safety systems. If stopping the sterilizer during a running process, press the Emergency stop button as first choice. Only switch off the power to the sterilizer if it is absolutely necessary.
WARNING RISK OF LEAKAGE During a power outage, or if the power to the sterilizer has been turned off during a process, there is a risk of steam leakage from the door.
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If there is positive pressure in the chamber during a power outage, keep away from the door and contact a local service technician.
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Index of warnings | 12
WARNING RISK OF INFECTION If the power fails or the ON/OFF switch or Emergency Stop button is turned off during processing, nonsterile, infectious material may leak from the door. If the pressure in the chamber is positive, Leave the area immediately and contact a local service technician.
WARNING RISK OF FORMALDEHYDE RESIDUES Risk of release of accumulated formaldehyde residues. Run cleaning program regularly.
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 RISK OF CROSS CONTAMINATION Do not process hazardous waste in this sterilizer.
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 | 13
Preface Before using the sterilizer, read all instructions and become familiar with the design, safety features and operation of the unit. Getinge Sterilization 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.
Before using the sterilizer, read all instructions and become familiar with the design, safety features and operation of the unit. Maquet 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 daily users, super users and administrators using the sterilizer. They are trained for their tasks, and familiar with day to day routines operating the sterilizer. The users are also familiar with national and local requirements and laws. For information about user groups and access rights, see see Chapter 5.2 “The Access Management System” on page 75see the .
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.
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Intended User
USER MANUAL
Symbols in this Manual
The following user documentation is supplied with the sterilizer:
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.
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.
0000005688
Warning chemical hazard.
0000006667
Warning fire hazard.
0000006623
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Related Publications
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Symbols in the Manual:
Description: Attention. Situations that may cause damage to equipment, load or loss of data. 0000005987
The note symbol alerts the user to important facts and conditions. It can also give recommendations on the usage of the unit. 0000005382
Symbols on the Sterilizer
The following symbols on the sterilizer informs users of possible hazards.
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.
Expected lifetime
Medical lifetime: 30 000 cycles corresponding to 11 years. The year of manufacture is stated at the data label of the sterilizer.
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 If additional help is required, contact an authorized Getinge service representative: www.getinge.com/contact-us
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Getinge Service
USER MANUAL
Manufacturer Address
Preface | 16
Getinge Sterilization AB Ekebergsvägen 26 305 75 Getinge Sweden +46 (0) 10 335 0000 [email protected]
Manufacturer Address
MAQUET GmbH Kehler Str. 31 76437 Rastatt Baden-Wuerttemberg GERMANY Telephone: +49 7222 932-0
Australian Sales & Service Address
Getinge Australia Pty Ltd 1/205 Queensport Road North Murarrie QLD 4172 Australia E-mail: [email protected] Cust. Support: 1300 155 500 Phone: +61 7 3399 3311 Fax: +61 7 3395 6712
1.2 Machine Identification The unique identification information for the sterilizer is found on the Sterilizer data plate, attached to the machine. When contacting Getinge concerning the sterilizer, information included in the data plate is required.
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The Sterilizer Data Plate
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Preface | 17
0000005677
1. Reference 2. Serial number 3. Manufacturer Address, Year and month of manufacturing 4. Frequency (Hz) and Connection voltage (V) 5. Nominal wattage (kW) 6. Nominal current (A) 7. Short-circuit current cap (kA) 8. Largest single load (A) 9. Fuse (A) 10. Control voltage (V) 11. Reference to electrical diagrams 12. Pressure (Bar) 13. Temperature (°C) 14. Reference to manuals
The unique identification information for the sterilizer is found on the Sterilizer data plate, attached to the machine. The CE mark ensures that the sterilizer complies with all relevant European directives of the European Economic Area (EEA) / the European Economic Community (EEC). When contacting Getinge concerning the sterilizer, information included in the data plate is required.
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Sterilizer Data Plate
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Preface | 18
0000005674
Figure 2: Sterilizer Data Plate 1. Reference 2. Serial number 3. Manufacturer Address, Year and month of manufacturing 4. Frequency (Hz) and Connection voltage (V) 5. Nominal wattage (kW) 6. Nominal current (A) 7. Short-circuit current cap (kA) 8. Largest single load (A) 9. Fuse (A) 10. Control voltage (V) 11. Reference to electrical diagrams 12. Pressure (Bar) 13. Temperature (°C) 14. Reference to manuals 15. CE sign followed by information about Pressure Equipment Directive 16. Intended Use 17 Space for information about Pressure Equpment Directive 18 Space for information about Notified Body
The unique identification information for the sterilizer is found on the Sterilizer data plate, attached to the machine. The CE mark ensures that the sterilizer complies with all relevant European directives of the European Economic Area (EEA) / the European Economic Community (EEC).
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Sterilizer Data Plate
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Preface | 19
This medical device unit is approved and registered by an accredited notified body. When contacting Getinge concerning the sterilizer, information included in the data plate is required.
0000005674
Figure 3: Sterilizer Data Plate
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1. Reference 2. Serial number 3. Manufacturer address, Year of manufacture 4. Frequency (Hz) and Connection voltage (V) 5. Nominal wattage (kW) 6. Nominal current (A) 7. Short-circuit current cap (kA) 8. Largest single load (A) 9. Fuse (A) 10. Control voltage (V) 11. Reference to electrical diagrams 12. Pressure (Bar) 13. Temperature (°C) 14. Reference to manuals 15 CE sign, 16 Intended Use 17 Space for information about Pressure Equpment Directive 18 Space for information about Notified Body
USER MANUAL
The unique identification information for the sterilizer is found on the Sterilizer data plate, attached to the machine. The CE mark ensures that the sterilizer complies with all relevant European directives of the European Economic Area (EEA) / the European Economic Community (EEC). This medical device unit includes a boiler and/or a pressure vessel. It is approved and registered by an accredited notified body.
0000005674
Figure 4: Sterilizer Data Plate 1. Reference 2. Serial number 3. Manufacturer Address, Year and month of manufacturing 4. Frequency (Hz) and Connection voltage (V) 5. Nominal wattage (kW) 6. Nominal current (A) 7. Short-circuit current cap (kA) 8. Largest single load (A) 9. Fuse (A) 10. Control voltage (V) 11. Reference to electrical diagrams 12. Pressure (Bar) 13. Temperature (°C) 14. Reference to manuals 15 CE sign 16 Intended Use 17 Space for Pressure Equipment Directive information 18 Space for Notified Bodyinformation
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Sterilizer Data Plate
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USER MANUAL
The unique identification information for the sterilizer is found on the Sterilizer data plate, attached to the machine. For EEA countries, the CE mark ensures that the sterilizer complies with all relevant European directives of the European Economic Area (EEA) / the European Economic Community (EEC).
0000005674
Figure 5: Sterilizer Data Plate 1. Reference 2. Serial number 3. Manufacturer Address, Year and month of manufacturing 4. Frequency (Hz) and Connection voltage (V) 5. Nominal wattage (kW) 6. Nominal current (A) 7. Short-circuit current cap (kA) 8. Largest single load (A) 9. Fuse (A) 10. Control voltage (V) 11. Reference to electrical diagrams 12. Pressure (Bar) 13. Temperature (°C) 14. Reference to manuals 15 CE sign, if applicable 16 Intended Use 17 Space for Pressure Equipment Directive information, if applicable 18 Space for Notified Bodyinformation, if applicable
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Sterilizer Data Plate
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1.3 Machine Identification The unique identification information for the sterilizer is found on the Sterilizer data label, attached to the machine. The information on this label might be required when contacting Getinge regarding the machine.
0000010103
Figure 6: Data Label
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1 Product number 2 Serial number 3 Name and address of the manufacturer and date of manufacture 4 Alternating current, Frequency (Hz) and Connection voltage (V) 5 Nominal wattage (kW) 6 Nominal current (A) 7 Short-circuit current cap (kA) 8 Largest single load (A) 9 Fuse (A) 10 Control voltage (V) 11 Reference to electrical diagrams 12 If applicable, symbol by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonization legislation providing for its affixing 13 If applicable, Medical Device Directive identification number of the relevant notified body/bodies which was/were involved in the conformity assessment procedure(s) 14 If applicable, Pressure Equipment Directive identification number of the relevant notified body/bodies which was/were involved in the conformity assessment procedure(s) 15 Symbol for do not dispose of at municipal collection points for used electrical equipment 16 Symbol for observe accompanying documents 17 Symbol for Following Operation Instructions 18 Temperature °C 19 Pressure (bar)