142 Sterilization / cleaning / disinfection
fabian HFO | SW 5.1.x
Ref: 113003.EN / Date 2020-02-10
5. After the drying process package immediately for sterilization in packaging suitable for vapor
sterilization. Ensure that packaging stays dry before autoclaving.
Note: Articles must be individually single pouched in a qualified pouch (e.g. Cardinal Health self-
sealing pouch CAT# 92713). Each of the non-critical devices in-scope are thermostable and
have been validated for steam sterilization.
14.2.2.3 Sterilization options
The recommended sterilization method is steam sterilization by autoclave. The following validated
cycles are suitable for sterilization:
Option A:
1. Set the autoclave with the following parameters
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 3 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the cassette articles
3. Autoclave the cassette articles using the cycle parameters in Step 1
Option B:
1. Set the autoclave with the following parameters
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 4 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the cassette articles
3. Autoclave the cassette articles using the cycle parameters in Step 1
Option C:
1. Set the autoclave with the following parameters:
• 4 preconditioning pulses
• Steam cycle at 134°C / 273°F for 5 minutes
• Dry cycle for 30 minutes
2. Individually single pouch the cassette articles
3. Autoclave the cassette articles using the cycle parameters in Step 1
14.2.2.4 Duration of use
The flow sensor must be replaced after 30 sterilization cycles and also in case that any detected defect is
affecting the accessory performance.
14.2.3 Exhalation membrane and membrane holder
WARNING:
Conduct hygienic preparation of exhalation membrane and exhalation membrane holder
prior to each use.
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