Users Reference Manual
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Cleaning and Sterilization User's Reference Manual
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 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, the manufacturer recommends that a telephonic or written request for service advice be made to the nearest manufacturer Customer Service Center. This product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer and by the manufacturer trained personnel. The product must not be altered without the prior written approval of the manufacturer. 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 the manufacturer.
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 Cleaning and sterilization Intended use... 2 ISO 17664 compliance... 3 Cleaning information...3 Cleaning and maintenance schedule... 6 Breathing system autoclavable parts... 7 Breathing system removal... 8 Removing the breathing system bag hose...8 Removing absorber canister...8 Removing the breathing system...9 Disassemble the breathing system...11 Breathing system disassembly... 11 Cleaning... 13 Compatible chemical agents... 13 Cleaning cassette kit...14 Automated washing... 17 Manual cleaning... 19 Sterilization... 21 Assemble the breathing system... 23 Breathing system assembly... 23 Install the breathing system... 26 Bellows assembly... 28 Disassemble the bellows assembly... 28 Assemble the bellows assembly... 30 Bellows assembly test... 33 Absorber canister... 35 Filling the reusable absorber canister... 35 Circuit O2 cell... 37
Index
2076865-001
i
ii
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Cleaning and sterilization Cleaning and sterilization
This User’s Reference manual provides information and instructions for the anesthesia breathing system assembly and disassembly, automated and manual cleaning, and sterilization. For reliable operation of the anesthesia breathing system, clean and sterilize the system according to the information in this manual. An overview of the cleaning process is described below. Detailed instructions for each step are provided within this manual. 1. 2. 3.
Remove the canister and breathing system. Disassemble the breathing system. Wash the identified parts and cleaning cassette in an automated washer. 4. Remove the parts from the automated washer and inspect parts for damage. 5. Attach the cleaning cassette to the breathing system. Wash the breathing system using the cleaning cassette in the automated washer. 6. Remove the parts from the automated washer and remove the cleaning cassette from the breathing system. Inspect parts for damage. 7. Manually clean parts that are not allowed in automated washer and inspect parts for damage. 8. Remove the bellows base and wrap the parts prior to sterilization. 9. Perform the sterilization. 10. Inspect parts for damage before reassembly. 11. Reassemble the bellows and breathing system parts, install the breathing system, and the canister. 12. The cleaning and sterilization is complete.
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Intended use This manual contains instructions for cleaning and sterilization of the Compact Breathing System (CBS). Follow these instructions for cleaning and sterilization of the system parts. Important
2
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.
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ISO 17664 compliance The process for sterilization of the breathing system has been validated by a third party firm 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 reprocessing is actually performed using equipment, materials, and personnel in the reprocessing facility to achieve 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. The manufacturer recommends the use of filter(s) that protect both the inspiratory and expiratory ports to reduce the risk of crosscontamination. See "Breathing system removal", "Breathing system disassembly", and "Sterilization".
Cleaning information Disinfect the breathing system prior to first use after installation. See "Compatible chemical 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 cleaning and disinfectant agent. Parts marked 134°C are autoclavable. All parts in the breathing system, except the circuit O2 cell and flow sensors, can be washed in an automated washer using mild detergent. Only surface clean the circuit O2 cell. Do not autoclave the circuit O2 cell. Do not wash the circuit O2 cell or flow sensors in an automated washer. A Cleaning Cassette kit is available to assist in the cleaning of the breathing system when using an automatic washer. Always perform a preoperative test after reassembly and prior to use. The anesthesia system User’s Reference manual contains a preoperative checkout list and preoperative test instructions. Inspect and replace any damaged parts in the breathing system, if the test failed.
WARNING
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Obey applicable safety precautions:
3
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 sterilization procedures.
•
A damaged O2 cell can leak and cause burns. Do not breathe the fumes.
•
Failure to properly install and use bacterial or viral filters in a way that protects the inspiratory and expiratory ports will result in additional required cleaning and sterilization procedures. If bacterial or viral filters are not used, perform the cleaning and sterilization procedures specified in this guide before each patient to avoid crosscontamination between patients.
•
The breathing system should be reprocessed regularly. Contamination is possible. Follow facility guidelines to determine requirements for reprocessing that addresses potential contamination, including an adequate minimum interval between reprocessing which addresses all potential sources of contamination.
•
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.
•
Obey infection control and safety procedures. Used equipment may contain blood and body fluids.
•
Moveable parts and removable components may present a pinch or a crush hazard. Use care when moving or replacing system parts and components.
CAUTION
4
•
To help prevent damage:
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• • •
• • • • • •
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Refer to the manufacturer’s data if you have questions about a cleaning agent. Follow facility procedures for cleaning areas of the machine not specified in this section. Do not wipe the surfaces or clean the system using organic, halogenated, or petroleum-based solvents, anesthetic agents, glass cleaners, acetone, or other harsh cleaning agents. Doing so can damage the labels or the system. 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 should not be used.
5
Cleaning and maintenance schedule Refer to the anesthesia system’s User’s Reference manual for complete maintenance instructions regarding the anesthesia system. Minimum Frequency Before each patient
During cleaning and setup As necessary
•
Wipe the anesthesia system’s external surfaces.
•
Inspect the parts for damage. Replace, repair or reprocess as necessary.
•
Wipe the anesthesia system’s external surfaces. Empty the absorber canister body 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 2 years). Replace the autoclavable flow sensors. (Under typical use the sensor meets specifications for a minimum of 1 year.)
• • • •
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Breathing system autoclavable parts
1
2
4
3
5
6
1. 2. 3. 4. 5. 6. 7.
AC.24.172
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Bellows housing and bellows with rim and pressure-relief valve Bellows base Bottom breathing system assembly APL diaphragm assembly Flow sensors Patient port assembly Reusable absorber canister
Figure 1 • Autoclavable assemblies
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Breathing system removal The breathing system patient circuit, bag hose, and canister must be removed before removing and disassembling the breathing system.
Removing the breathing system bag hose 1.
Disconnect the bag hose from the bag hose port.
1
AC.24.328
2
1. 2.
Bag hose port Bag hose connection
2. 3.
Remove the bag from the holder at the end of the bag arm. Remove the bag hose from the clip and the bag arm base. 2
3
AC.24.325
1
1. 2. 3.
Holder Clip Bag arm base
Removing absorber canister 1.
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Pull down the canister lifter handle to unlock the canister from the breathing system.
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AC.24.071
Lift the canister and remove it from the canister lifter base.
3.
See "Absorber canister" for cleaning and filling instructions.
AC.24.072
2.
Removing the breathing system 1.
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Open the breathing system door. Push the release button to unlock the breathing system.
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AC.24.154 AC.24.155
Grasp the breathing system base, rotate down and pull the assembly away from the anesthesia machine.
AC.24.156
2.
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Disassemble the breathing system The breathing system assembly can be disassembled for cleaning, sterilization, and part replacement.
Breathing system disassembly Push the patient port assembly tab and pull the assembly from the breathing system.
2.
Pull out both of the flow sensors.
AC.24.158
AC.24.157
1.
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Remove the APL valve diaphragm assembly.
AC.24.159
3.
12
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Cleaning Use the recommended method to clean the breathing system parts. See "Compatible chemical agents" for a list of cleaning agents that have been tested and found to cause no harm to breathing system parts.
Compatible chemical agents The compatible chemical agents listed have been tested and found not to cause harm to the anesthesia system 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 cleaning or disinfection has not been demonstrated in all cases. The compatible chemical agents listed may not be available or approved for use in all countries. Follow hospital guidelines for cleaning and chemical agent use.
CAUTION
Important Note
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. The use of chlorinated cleaning and disinfecting agents on metal parts can over time lead to small cosmetic surface oxidation spots on the metal parts.
Surface cleaning and disinfection
Chemical agent
Concentration
Cidex
Refer to manufacturer labeling.
Cidex OPA
Refer to manufacturer labeling.
Virex 256
Refer to manufacturer dilution recommendations.
Wescodyne
Refer to manufacturer dilution recommendations.
Sporicidin
Refer to manufacturer dilution recommendations.
Clorox Bleach
13.0 oz to 1 gal of water
70% Isopropyl Alcohol Refer to manufacturer labeling.
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Chemical agent
Concentration
Automated washing Prolystica Ultra concentrate Neutral Detergent, Steris
Dispensed at 0.8 ml per liter of water
Manual cleaning
4 ml per liter of water
Prolystica 2x Neutral Detergent Neutral, Steris
Cleaning cassette kit The cleaning cassette kit is intended to enhance the cleaning of the breathing system. Using the cleaning cassette and automated washer plugs provides effective particulate removal using optimal water flow management through the breathing system parts. Disassemble the breathing system to the level shown in the "Breathing system removal" and "Disassemble the breathing system" procedures. Plug the unused washer ports before starting the automatic washer, using the cleaning cassette. After washing, remove the parts from the washer and drain any water. Allow parts to cool and dry completely before reassembling the breathing system.
3
2
4
1 AC.24.179
5
6
7
1. 2. 3.
14
8
Flow sensor blank assembly O2 cell plug Inspiratory port plug
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4. 5. 6. 7. 8.
Bag/Vent switch assembly APL plug Bag port plug Negative pressure valve plug Base assembly
Figure 2 • Cleaning cassette kit (Part number: 2081163-001)
Attaching the cleaning cassette kit 1.
2.
Remove the patient port, flow sensors, and APL valve diaphragm assembly from the breathing system as described in "Breathing system disassembly". Attach the cleaning kit to the breathing system as shown. • • • • •
AC.24.204
•
With the Bag/Vent switch set in the middle position, slide the Bag/Vent switch assembly over the Bag/Vent switch. Press the APL plug onto the APL base. Press the flow sensor blank assembly into the inspiratory and expiratory ports. Re-insert the patient port into the flow sensor assembly. If the machine has an O2 cell, use the O2 cell plug to seal the O2 cell base. If there is no O2 cell, do not connect the O2 cell plug. Plug the inspiratory port with the inspiratory port plug.
3.
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Turn over the breathing system.
15
Attach the cleaning kit to the bottom of the breathing system as shown.
5.
Attach 22-mm hoses to the expiratory port, bypass port, and bag port.
6. 7.
Turn over the breathing system. Attach the other end of the hoses to the ports on the automated washer. Keep the breathing system upright and put it into the automated washer.
AC.24.178
AC.24.177
4.
16
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