15 Sterilization / cleaning / disinfection 107
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
15.2.2.3 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:
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 3 minutes
1.3. 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
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 4 minutes
1.3. 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:
1.1. 4 preconditioning pulses
1.2. Steam cycle at 134°C / 273°F for 5 minutes
1.3. Dry cycle for 30 minutes
2. Individually single pouch the cassette articles
3. Autoclave the cassette articles using the cycle parameters in Step 1
15.2.2.4 Duration of use
The flow sensor must be replaced after 30 sterilization cycles and also in case of any
detected defect that is affecting the accessory performance.
15.2.3 Exhalation membrane and membrane holder
WARNING:
Conduct hygienic preparation of exhalation membrane and exhalation membrane holder
prior to each use.
15.2.3.1 Disassembly
1. Remove the exhalation membrane holder and membrane from the ventilator:
1.1. Disassemble the membrane holder from the expiratory limb port by rotating
the holder a quarter of turn in counter-clockwise direction and then pull it
out from the port.