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fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
2. Pre
recommendation of 10 mL per Liter using utility (tap) water 20°C / 68°F - 30°C / 86°F.
3. Transfer the flow sensor onto the 4-Level manifold rack accessory (or other appropriate rack
system) contained inside the washer for processing.
4. Select the appropriate cycle as listed below:
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.
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
• 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
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