GE Aisys Advanced Breathing Systems ABS Cleaning and Sterilization Users Reference Manual

Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare.

User Responsibility 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 instructions 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 Datex-Ohmeda 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 local laws for any restriction that may apply. Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture, and a sequential unit number for identification. The serial number can be in one of two formats.

AAAX11111 The X represents an alpha character indicating the year the product was manufactured; H = 2004, J = 2005, etc. I and O are not used.

AAAXX111111AA The XX represents a number indicating the year the product was manufactured; 04 = 2004, 05 = 2005, etc.

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.

Table of Contents Intended use... 1 ISO 17664 compliance... 1 Cleaning information... 1 Maintenance summary and schedule... 4 Breathing system autoclavable parts... 5 Breathing system removal... 6 Removing the breathing system bag hose... 6 Removing a standard canister... 6 Removing an EZchange canister... 7 Removing the breathing system... 8 Disassemble the breathing system... 9 Simple breathing system disassembly... 9 Full breathing system disassembly... 13 Bellows assembly... 16 Disassemble the bellows assembly... 16 Assemble the bellows assembly... 18 Bellows assembly test... 20 Cleaning the bellows... 21 AGSS reservoir and receiver... 22 Remove the AGSS reservoir and receiver... 22 Remove the AGSS receiver filter... 24 EZchange canister module and condenser (optional)... 25 Assemble the breathing system... 28 Full breathing system assembly... 28 Simple breathing system assembly... 31 Install the breathing system... 34 Cleaning... 36 Autoclaving... 36 Automated washer... 37

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Cleaning and Sterilization Cleaning agents... 38 Flow sensor cleaning and disinfection... 39 Manual disinfection... 39 Flow sensor cleaning kit... 43 Circuit O2 cell... 45 Absorber canister... 46 Reusable Multi Absorber canister... 46 Absorber canister cleaning... 49 Cleaning cassette kit... 50 Bellows assembly... 50 Breathing circuit module... 52 EZchange canister module... 54 Condenser and EZchange canister module... 56 Condenser... 57

Index

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Intended use This manual contains instructions for cleaning and sterilization of the Advanced Breathing System (ABS). Follow facility guidelines for cleaning and disinfection for parts. Important

Use this manual along with the anesthesia system’s User’s Reference manual. Always perform a preoperative checkout before using the anesthesia machine after reassembly. Refer to the “Preoperative Tests” section of the anesthesia system’s User’s Reference manual.

ISO 17664 compliance The process for autoclave sterilization of the Advanced Breathing System has been tested by a third party firm and found to be in compliance with ISO 17664:2004. Compliance to ISO 17664:2004 only applies when bacterial/viral filters are used to filter air coming in from the patient and returning air to the patient. Filters must be properly installed. Follow “Breathing system removal,” “Simple breathing system disassembly,” “Autoclaving,” and “Canister autoclaving.”

Cleaning information

Clean the breathing system prior to first use after installation. See “Cleaning agents” for a list of the approved cleaning agents. 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 disinfectant. Parts marked 134°C are autoclavable. All parts except the circuit O2 cell, plastic flow sensors, and metal flow sensors can be washed in an automated washer using mild detergent. Only plastic flow sensors can be washed manually. Do not autoclave plastic flow sensors. Do not wash plastic flow sensors or metal flow sensors in an automated washer. Do not manually wash metal flow sensors. Only surface clean the circuit O2 cell. Do not autoclave the circuit O2 cell. Do not wash the circuit O2 cell in an automated washer. A Flow Sensor Cleaning kit is available to assist in the manual washing of the plastic flow sensors. A Cleaning Cassette kit is available to assist in the cleaning of the bellows assembly, breathing circuit module, EZchange canister module, and condenser when using an automatic washer.

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Cleaning and Sterilization WARNING

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2

Obey applicable safety precautions: •

Read and understand the material safety data sheet for each cleaning agent.

•

Read and understand the manual for all sterilization equipment to be used.

•

Follow facility guidelines for use of personal protective equipment during cleaning and disinfection procedures.

•

A damaged O2 cell can leak and cause burns. Do not breathe the fumes.

To help prevent fires: •

All covers used on the system must be made from antistatic (conductive) materials. Static electricity can cause fires.

•

Desiccated (dehydrated) absorbent material may produce dangerous chemical reactions when exposed to inhalation anesthetics. Adequate precautions should be taken to ensure that absorbent does not dry out. Turn off all gases when finished using the system.

w

Obey infection control and safety procedures. Used equipment may contain blood and body fluids.

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Moveable parts and removable components may present a pinch or a crush hazard. Use care when moving or replacing system parts and components.

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CAUTION

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To help prevent damage: •

Refer to the manufacturer’s data if you have questions about a cleaning agent.

•

Follow hospital procedures for cleaning areas of the machine not specified in this section.

•

Do not use organic, halogenated, or petroleum-based solvents, anesthetic agents, glass cleaners, acetone, or other harsh cleaning agents.

•

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 15 minutes. Swelling or accelerated aging can occur.

•

Only autoclave parts marked 134°C. Do not exceed 134°C.

•

Cleaning solutions must have a pH of 7.0 to 10.5. Organic, halogenated or petroleum-based solvents, anesthetic agents, glass cleaners, acetone, and other harsh cleaning agents are not recommended.

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Cleaning and Sterilization

Maintenance summary and schedule These schedules indicate the minimum frequency of maintenance based on typical usage of 2000 hours per year. Service the equipment more frequently if it is used more than the typical yearly usage. Note

Local policies or regulations may require that maintenance be performed more frequently than stated here. Visually inspect parts when disassembling the breathing system. Replace any parts that are visibly cracked, chipped, distorted, or worn. Refer to the anesthesia system’s User’s Reference manual for additional maintenance instructions regarding the anesthesia system.

Minimum Frequency

Maintenance

Daily

• •

During cleaning and setup

•

Every 12 months

• •

As necessary

• • • • •

•

4

Clean the external surfaces. Empty the water reservoir and replace the absorbent in the canister. Inspect the parts for damage. Replace or repair as necessary. Empty the Anesthesia Gas Scavenging System (AGSS) reservoir. Replace as needed. Inspect and clean or replace the filter on the active AGSS receiver. Clean the external surfaces. Empty the absorber canister water reservoir and replace the absorbent in the canister. Empty the overflow trap on the optional suction regulator. Replace the circuit O2 cell. (Under typical use the cell meets specifications for 1 year.) Replace the disposable flow sensor (plastic). (Under typical use the sensor meets specifications for a minimum of 3 months.) Replace the autoclavable flow sensors (metal). (Under typical use the sensor meets specifications for a minimum of 1 year.)

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Breathing system autoclavable parts

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9

3

1 10 4 8

7

6

5

AB.82.008 AB.82.045 AB.82.048

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1. Bellows assembly 2. APL valve ramp 3. APL valve diaphragm 4. Breathing circuit module (O2 cell not autoclavable) 5. Absorber canister (reusable only) 6. Flow sensor cover* 7. Flow sensor module (plastic flow sensors not autoclavable) 8. Exhalation valve assembly 9. Condenser module** 10. Condenser** 11. EZchange canister module**

Figure 1 • Autoclavable assemblies *This part is not interchangeable between some anesthesia systems. **These parts are optional.

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Cleaning and Sterilization

Breathing system removal The breathing system bag hose and the canister must be removed before removing and disassembling the breathing system.

Removing the breathing system bag hose

1. Disconnect the bag hose (1) from the bag hose connector (2). Also remove the hose from the clip (3). 2

3

AB.74p057

1

2. If bag arm option is present, 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. 1. Hold the canister by the handle and push the release latch to unlock the canister.

AB.74p058

Removing a standard canister

2. Remove the canister by tilting it downward and off the two support pins. 3. See “Absorber canister” for cleaning and filling instructions.

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1. Hold the canister by the handle and push the canister cradle release latch to unlock the canister cradle.

AB.75p088

Removing an EZchange canister

AB.75p089

2. Slide the canister up and out of the cradle.

3. See “Absorber canister” for cleaning and filling instructions.

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Cleaning and Sterilization

Removing the breathing system

1. Remove the EZchange module and condenser if attached. See “EZchange canister module and condenser (optional)” for removal instructions. • For simple breathing system disassembly, do not disassemble the EZchange module or the condenser. 2. Push the release button (1) and gently pull the latch handle (2) to release the breathing system.

AB.74p059

1

2

AB.74p060

3. Grasp the rear handle to support the breathing system. Slide the breathing system away from the workstation by pulling under the latch handle.

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Disassemble the breathing system The breathing system assembly can be disassembled for cleaning, sterilization, and part replacement. The breathing system assembly can be fully disassembled or partially disassembled prior to cleaning. Disassemble the breathing system to the level specified by the facility. For partial disassembly of the breathing system, perform the “Simple breathing system disassembly” procedure. For full disassembly of the breathing system, complete the “Simple breathing system disassembly,” “Full breathing system disassembly,” and “Disassemble the bellows assembly” procedures.

Simple breathing system disassembly

Simple breathing system disassembly is recommended for autoclave sterilization. Do not disassemble the bellows assembly.

AB.74p063

1. Remove the breathing system and place it upright on a flat surface.

AB.74p052

2. Pull the latch to unlock the flow sensor module from the breathing system.

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Cleaning and Sterilization

AB.74p064

3. Pull the flow sensor module from the breathing system.

AB.74p065

4. Remove the circuit O2 cell. • Remove the O2 cell cable from the cell. • Unscrew the O2 cell counterclockwise and remove it. • Make sure that the o-ring remains on the O2 cell. • Remove the O2 cell cable from the breathing system by pressing on the connector button while pulling the connector out.

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5. Remove the flow sensors from the module. • Completely loosen the thumbscrew (1). • Pull off the flow sensor cover (2) from the flow sensor holder. • Remove the flow sensor connectors (3) from the flow sensor holder. • Pull the flow sensors (4) from the flow sensor holder. 3

2

AB.74p053

1

4

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Cleaning and Sterilization

AB.74p066

6. Rotate the breathing circuit module counterclockwise at the point shown by the dotted line.

AB.74p067

7. After rotating, separate the two sections by pulling them apart.

8. For simple disassembly of the breathing system, the disassembly is complete after this step. For full disassembly of the breathing system, continue with the “Full breathing system disassembly” and “Disassemble the bellows assembly” procedures.

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Full breathing system disassembly

1. Perform the “Simple breathing system disassembly” procedure. 2. Disassemble the breathing circuit module. • Remove the check valve circuit lens (1) by squeezing the latches (2) together and pulling up on the lens. • Lift out the check valve assemblies (3).

AB.74p068

1

2 3

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Cleaning and Sterilization 3. Press the latch on the bellows assembly (1) to unlock the ramp (2). Lift the ramp and remove the tabs from the slots (3) to remove the ramp.

2 1

AB.74p070 AB.74p071

3

AB.74p072

4. Lift the APL valve diaphragm to remove it.

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AB.74p073

5. Turn the bellows base assembly over, grasp the bellows manifold with three fingers in the openings at the points shown and pull to remove it.

AB.74p075

6. With the breathing system removed, the exhalation valve assembly can be removed for cleaning if desired. Loosen the two thumbscrews indicated and lift the assembly off.

WARNING

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Make sure the relief valve on the exhalation valve assembly is free of cleaning solution residue prior to reassembling the breathing system. Residual cleaning solution may impede valve performance.

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Cleaning and Sterilization

Bellows assembly The bellows assembly can be disassembled for cleaning, sterilization, and part replacement. Do not disassemble the bellows assembly for autoclaving. 1. Turn the housing counterclockwise and lift.

AB.82p012

Disassemble the bellows assembly

AB.82p013

2. Remove the bottom edge of the bellows from the rim.

AB.82p014

3. Push the latch toward the center and remove the rim.

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