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9 Sterilisation
55000-00012_002_01 – 1695233 – 25/01/2018
9.3.2
Cleaning and disinfection
Sterilisation faults lead to product damage
Product damage may result when the specifications and instructions
provided below are not considered or adhered to. Furthermore, it would
render any claim for damages void!
• Do not use dry-heat sterilisation for sterilisable handles.
Cleaning
The sterilisable handles may be cleaned with mildly alkali cleaners without active
chlorine. Trumpf Medical recommends neodisher mediClean (forte) at a
concentration of 0.5 % (5 ml/l).
1. Pull the sterilisable handle off the handle adapter.
2. Clean the sterilisable handle with cleaning agent.
3. Thoroughly rinse off cleaning agents with tap water.
Disinfection
Use wipe-over or spraying as the method of disinfection. Trumpf Medical
recommends products based on alcohol or aldehyde that are approved by the
manufacturer for use on PPSU.
4. Disinfect the sterilisable handle.
5. Check the sterilisable handle for material damage, cracks or deformation and
exchange damaged handles.
6. Check the cover pane (where present) for firm attachment and exchange the
handle as required.
An automatic method using a machine (disinfector) should be used for cleaning /
disinfection in accordance with DIN EN ISO 15883-1. The effectiveness of the method
used must be generally accepted (e.g. be included in the list of the disinfectants and
procedures checked and approved by the Robert Koch-Institute / DGHM) and must
already be validated in principle.
When using other methods (e.g. manual methods), the effectiveness of the method
must be verified in principle in the course of validation.
The Vario-TD standard cleaning programme provided by the Miele company or
programmes that adhere to the following time and temperature values can in
principle be used for machine-based cleaning:
9.3.3
Sterilisation
General information
• The sterilisation methods must be validated in accordance with EN ISO 17665-1
and EN ISO 17665-2;
• Only use fractionated pre-vacuum;
• The temperatures may not exceed 135 °C.
NOTE
Phase
Temperature
Time
Pre-rinsing
20 °C
60 seconds
Cleaning
20 - 55 °C
300 seconds
Neutralisation
24 - 55 °C
60 seconds
Intermediate rinsing
20 - 24 °C
60 seconds
Disinfection
93 °C
300 seconds
Drying
100 °C
25 minutes
