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Cleaning and Sterilization User's Reference Manual
User responsibility Datex-Ohmeda, Inc. a General Electric Company, doing business as GE Healthcare. This product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instruction provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest DatexOhmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A., check the local laws for any restriction that may apply.
Table of Contents Processing information Intended use... 2 ISO 17664 compliance... 2 Cleaning, disinfection, and sterilization glossary... 2 General information... 4 Trademarks... 4 Processing overview...5 Component processing compatibility... 6 Circuit O2 cell... 7 Surface cleaning and disinfecting...8 Cleaning instructions... 8 Disinfecting instructions... 8 Cleaning accessories... 10 Compatible chemical agents...11 Advanced Breathing System components... 12 Advanced Breathing System removal... 13 Remove the breathing system bag hose... 13 Remove the absorber canister... 13 EZchange module and condenser (optional)... 14 Remove the bellows assembly and breathing circuit module... 17 Disassemble the Advanced Breathing System... 19 Absorber canister (reusable) overview...19 Disassemble the bellows assembly and breathing circuit module... 22 Bellows housing overview... 26 Disassemble the bellows housing assembly... 27 Flow sensor processing... 29 Flow sensor cautions and warnings... 29 Flow sensor cleaning... 30 Flow sensor disinfection... 31
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Cleaning and Sterilization Flow sensor sterilization (autoclave)... 32 Flow sensor cleaning (metal autoclavable 1503-3244-000)... 33 Manual cleaning... 35 Soaking method... 35 Automated cleaning... 37 Automated washing... 37 Bellows assembly base - automated washing using cleaning accessory... 38 Breathing circuit module - automated washing using cleaning accessory... 40 EZchange module - automated washing using cleaning accessory... 42 Sterilization (Autoclave)... 48 Assemble the Advanced Breathing System... 50 Assemble the bellows assembly... 50 Assemble the Reusable Multi Absorber canister... 54 Assemble the breathing circuit module... 60 Advanced Breathing System installation... 66 Install the Advanced Breathing System... 66 Install the EZchange module or condenser module and condenser... 67
AGSS Remove the AGSS... 70 Remove the AGSS receiver filter... 73
Index
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Processing information Processing information
Process the breathing system prior to the first use after installation. Immediately clean potentially infectious material, for example blood or secretions, from the system by wiping the contaminated area using a disposable cloth and an approved chemical agent. See "Compatible chemical agents" for a list of the approved cleaning agents.
WARNING
CAUTION
•
Obey infection control and safety procedures. Used equipment may contain blood and body fluids.
•
Moveable parts and removable components may represent a pinch or a crush hazard. Use care when moving or replacing system parts and components.
•
The breathing system should be processed regularly. Contamination is possible. Follow facility guidelines to determine requirements for processing that address potential contamination, including an adequate minimum interval between processing which addresses all potential sources of contamination.
To help prevent damage: • • • • • • • •
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Refer to the manufacturer's data for specific cleaning agent information. Follow facility procedures for cleaning areas of the machine not specified in this manual. Do not use abrasive cleaning agents (such as steel wool, silver polish or cleaner). Keep all liquids away from electronic parts. Do not permit liquid to go into the equipment housings. Do not soak parts for more than 30 minutes unless indicated. Swelling or accelerated aging can occur. Parts marked 134°C are autoclavable. Do not exceed 134°C. Cleaning solutions must have a pH of 7.0 to 10.5. Do not use organic, halogenated or petroleum-based solvents, anesthetic agents, glass cleaners, acetone, and other harsh cleaning agents.
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Intended use Use this manual along with the anesthesia system User’s Reference manual. Always perform a preoperative checkout before using the anesthesia machine after reassembly. The anesthesia system User’s Reference manual contains a preoperative checkout list and preoperative test instructions.
ISO 17664 compliance The process for sterilization of the breathing system has been validated and found to be in compliance with ISO 17664. These instructions have been validated by the manufacturer of the medical device as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to make sure that the processing is actually performed using equipment, materials, and personnel in the processing facility to the desired result. This requires validation and routine monitoring of the process. Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Contamination from environmental exposure and crosscontamination from patient exposure are possible. It is recommended that filter(s) that protect both the inspiratory and expiratory ports are used to reduce the risk of contamination.
Cleaning, disinfection, and sterilization glossary .
Term
Standard
Definition
Cleaning
ISO 17664:2004
Removal of contamination from an item to the extent necessary for further processing or for intended use.
Disinfection
ISO 17664:2004
Activity used to reduce the number of viable microorganisms on a product to a level previously specified as appropriate for its further handling or use. GEHC Note: All disinfection specified in this manual is High-level disinfection.
High-level disinfection
AAMI TIR 12:2010
Process that kills all microbial organisms but not necessarily large numbers of bacterial spores.
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Term
Standard
Definition
Manual Cleaning
ISO 17664:2004
Cleaning without the use of a washerdisinfector.
Processing
ISO 17664:2004
Activity including cleaning, disinfection and sterilization, necessary to prepare a new or used medical device for its intended use.
Sterilization
ISO 17664:2004
Process used to render a device free from all forms of viable microorganisms.
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General information Note
Photos throughout the manual are for reference only.
Trademarks Advanced Breathing System, Disposable Multi Absorber, EZchange, and Reusable Multi Absorber are registered trademarks of Datex-Ohmeda, Inc. Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.
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Processing overview This User’s Reference manual provides information and instructions for the Advanced Breathing System assembly and disassembly, manual cleaning, automated washing, and sterilization. For reliable operation of the Advanced Breathing System, clean and sterilize the system according to the information in this manual. An overview of the typical processing activity is described below. Not all components may follow these specific steps. Detailed instructions for each step are provided within this manual. Important
All parts must use the manual cleaning/soaking process or the automated washer process (if appropriate) before sterilization. 1. 2. 3.
Remove the absorber canister and breathing system. Disassemble the breathing system. Manually clean parts that are not allowed in the automated washer or if washer is not available, manually clean all parts. 4. Visually inspect parts for damage, deformations, cracking, and cleanliness. Replace parts as necessary. 5. Attach the cleaning accessories to the breathing system parts. Wash the breathing system using the cleaning accessories in the automated washer. 6. Remove the parts from the automated washer and remove the cleaning accessories from the breathing system parts. 7. Visually inspect parts for damage, deformations, cracking, and cleanliness. Replace parts as necessary. 8. Wrap parts prior to sterilization. 9. Perform sterilization (check parts for 134°C). 10. Allow parts to completely dry and cool. 11. Visually inspect parts for damage, deformations, cracking, and cleanliness before reassembly. Replace parts as necessary. 12. Reassemble the bellows and breathing system parts, install the breathing system, and the absorber canister.
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Component processing compatibility The table shows the compatibility of breathing system components with processing methods. All parts must use the manual cleaning/ soaking process or the automated washer process (if appropriate) before sterilization. Important
If a cell contains an x, the processing method is compatible with the corresponding component. If a cell is blank, the processing method is not compatible with the component. .
Component
Manual cleaning
Automated washer without cleaning kit/ accessory
Automated washer with cleaning kit/ accessory
Autoclave (sterilization)
Bellows housing assembly •
Bellows housing
•
Bellows
•
Rim
•
Pressure relief valve assembly
•
Latch (rim)
•
Seal (bellows base)
x
x
x
x
x
x
x
x
x
x
x
x
Bellows assembly base •
APL valve ramp
•
APL valve diaphragm (includes APL valve poppet and cage)
Bag elbow port (reusable only)
x
x
x
x (as part of the Bellows x assembly base)
x
x (as part of the Bellows x assembly base)
x
x
Breathing circuit module (without O2 cell)
x x
x
O2 cell plug
x
x
Absorber canister (reusable only)
x
x
Flow sensor cover
x
x
Flow sensor module (without flow sensors)
x
x
Condenser module
x
x
Condenser
x
x
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Component
Manual cleaning
Automated washer without cleaning kit/ accessory
EZchange module
Important
CAUTION Important
Automated washer with cleaning kit/ accessory
Autoclave (sterilization)
x
x
See "Flow sensor cleaning", "Flow sensor disinfection", "Flow sensor sterilization (autoclave)", and "Flow sensor cleaning (metal autoclavable 1503-3244-000)" for detailed instructions on cleaning, disinfection, and sterilization of flow sensors.
Do not put Flow sensors in an automated washer. Follow facility guidelines for processing flow sensors not included in the manual such as 1503-3856-000 and 1503-3858-000. .
Component
Manual cleaning
Flow sensor (2087640-001)
x
Flow sensor (2089610-001)
x
Metal Autoclavable Flow Sensor (1503-3244-000)
x
Disinfection
Autoclave (sterilization) x
x x
Circuit O2 cell Only surface clean the circuit O2 cell. Clean the circuit O2 cell by wiping it with a damp cloth. Do not get the circuit O2 cell wet.
CAUTION • • WARNING
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Do not autoclave the circuit O2 cell or damage will occur. Do not place the circuit O2 cell in liquid or damage will occur.
The circuit O2 cell cannot be disinfected. Be aware that cross-contamination is possible.
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Surface cleaning and disinfecting External parts and exposed surfaces that are touched while using this device must be cleaned and disinfected when soiled. Follow healthcare facility guidelines for cleaning and disinfecting intervals. Refer to the full documentation set provided with the device for additional cleaning and disinfecting information.
CAUTION
Do not use a dripping cloth on surfaces. Make sure there is no liquid pooling on surfaces or entering the device. Damage to the device could occur. Replace the cloth as needed.
WARNING
Make sure that cleaning and disinfecting solutions do not penetrate the inside of the device. Electrical shock could occur.
Cleaning instructions Cleaning solution Bleach solution (1:10 diluted 5.25% sodium hypochlorite solution)
•
• •
Thoroughly clean the surfaces of the device with a lint-free cloth pre-soaked with the cleaning solution. Wring excess liquid from the cloth before wiping the surfaces. Clean the surfaces until soil and organic matter is visibly removed. Pay attention to connected surfaces, recessed areas, ridges, and other difficult to clean areas of the device. Inspect the device to confirm the complete removal of soil from surfaces. If soil is still present, clean the device again.
Disinfecting instructions .
Disinfectant solution
Disinfection time
Bleach solution (1:10 diluted 5.25% sodium hypochlorite solution)
Keep the surface wet for 5 minutes.
• • •
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Always clean the surfaces of the device before disinfecting. Wet the surfaces by wiping them with lint-free cloth pre-soaked with disinfectant solution. Wiped surfaces must remain wet with the disinfectant solution for the stated disinfection time.
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If the surface dries before the disinfection time duration, wipe the surface again with another new lint-free cloth pre-soaked with disinfectant solution.
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Cleaning accessories The accessories are intended to aid in the cleaning of the Advanced Breathing System and aid in cleaning flow sensors. Part number
Description
M1086464
Flow sensor cleaning rack (sold separately). Helps prevent flow sensor connectors from becoming wet.
M1086468
Flow sensor cleaning rack with tub. Flow sensor cleaning rack (sold separately - M1086464) helps prevent flow sensor connectors from becoming wet.
AC.27.003
AC.27.005
Accessory
M1107977
Cleaning Cassette Kit ABS and EZchange This kit contains the items listed in the following rows. Cleaning cassette - Use for automated washing of the breathing circuit module, EZchange module, and condenser.
M1107970
Multi-cap cleaning accessory - Use with Cleaning cassette (M1107966) for automated washing of the breathing circuit module and EZchange module.
M1107973
Bellows plug - Use for automated cleaning of the bellows assembly base.
AC.27.008
AC.27.007
AC.27.006
M1107966
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Compatible chemical agents The compatible chemical agents listed have been tested and found not to cause harm to the Advanced Breathing System (ABS) parts. Read the material safety data sheet (MSDS) for each chemical agent. Use of these chemicals will not damage the components when used as suggested, but efficacy of processing has not been demonstrated in all cases. The compatible chemical agents listed may not be available or approved for use in all countries. Follow the facility guidelines for cleaning and chemical agent use. See "https://cleaning.gehealthcare.com" for a current list of approved cleaning agents for use on external surfaces.
CAUTION
Cleaning solutions not shown in the chemical agents list must have a pH of 7.0 to 10.5. Organic, halogenated or petroleum-based solvents, anesthetic agents, glass cleaners, acetone, and other harsh chemical agents are not recommended.
•
Use of any chemical agents other than listed in this table may degrade system performance. .
External surfaces
Chemical agent/Detergent
Concentration
Bleach
1:10 dilution of 5.25% - 6.5% sodium hypochlorite
Isopropyl alcohol
70%
Manual cleaning
Prolystica 2x Concentrate Neutral Detergent
Automated cleaning
Prolystica Ultra Concentrate Neutral Detergent
Flow sensors (2087640-001 and 2089610-001) manual cleaning
Prolystica 2x Concentrate Neutral Detergent
Flow sensor (2089610-001) disinfection
Sporox II
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• •
4 ml per liter of water 1/2 oz per gallon of water
• •
0.8 ml per liter of water 1/10 oz per gallon of water
• •
1 ml per liter of distilled water 0.128 fluid oz per gallon water
100% - do not dilute with water. • •
500 ml per flow sensor 16.9 oz per flow sensor
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Advanced Breathing System components
8
1
12 9
2 13 14 3
7
4
10
5 6 11
15
19
18
AB.82.139
16
17
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Bellows housing Bellows Rim Pressure relief valve assembly Latch, rim Seal, bellows base Bellows assembly base APL valve ramp APL valve ramp diaphragm Breathing circuit module
11. 12. 13. 14. 15. 16. 17. 18. 19.
O2 cell plug or O2 cell + cable (not pictured)*** Bag elbow port Condenser module** Condenser** EZchange module** Absorber canister (reusable) Flow sensor cover* Flow sensor module Flow sensors
Figure 1 • Advanced Breathing System components *This part is not interchangeable between some anesthesia systems. **Part is optional. *** O2 cell plus cable cannot be processed.
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Advanced Breathing System removal The breathing system bag hose and the absorber canister must be removed before removing and disassembling the breathing system.
Remove the breathing system bag hose 1.
Disconnect the bag hose (1) from the bag hose connector (2). Remove the hose from the clip (3). 2
1
AB.82p.039
3
2.
If the bag arm option is connected, remove the bag port elbow from the bag arm support. Push down on the release latch and slide the bag port elbow out of the holder.
Remove the absorber canister The absorber canister is available in two versions: Disposable Multi Absorber and Reusable Multi Absorber. Both absorber canisters are installed and removed on the breathing system or EZchange module (optional) the same way. Only the Reusable Multi Absorber canister can be cleaned using the automated washer and autoclave.
Remove the absorber canister from the breathing system Remove the absorber canister from the system. 1.
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Hold the canister by the handle and push the release latch to unlock the canister.
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AB.74p058
Cleaning and Sterilization
2. 3.
Remove the canister by tilting it downward and off the two support pins. See "Disassemble the absorber canister (reusable)".
Remove from the EZchange module 1.
Hold the absorber canister by the handle and push the release latch (2) to unlock the canister cradle from the EZchange module (1).
AB.75p137
1 2
Slide the canister up and out of the cradle.
3.
See "Disassemble the absorber canister (reusable)".
AB.75p089
2.
EZchange module and condenser (optional)
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The EZchange module and condenser are each optional features and can be removed for cleaning and sterilization. They can be removed as part of the breathing system or individually.
1
AB.82p007
2
3
4 1. 2. 3. 4.
EZchange module release latch EZchange canister release latch Condenser Condenser reservoir
Figure 2 • EZchange module and condenser option
Remove the EZchange module and condenser 1.
Note
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With the absorber canister removed, push the EZchange module release latch and pull down on the unit to remove it from the breathing system. Skip steps 2 through 5 if using the automated washer with a cleaning kit.
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Cleaning and Sterilization For systems with the EZchange module only, pull the release latches out to remove the cap.
3.
For systems with a condenser or a combination EZchange module with a condenser, pull the release latches out to remove the condenser from the module.
4.
Remove the condenser reservoir by pulling the lip of the gasket away from the reservoir around the edges.
AB.75p079
AB.75p078.cl
2.
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