Pari PEP System I Instrucciones De Uso página 38

Possible alternative: Chemical-thermal disinfection
• Place the disassembled components of the PARI PEP System in the
instrument disinfector.
• Add a suitable cleaning agent/disinfectant and select the 60 °C
programme.
Storage
• Between use, wrap the PARI PEP System in a clean, lint-free cloth and
keep it in a dry, dust-free environment protected from possible sources of
contamination.
6.4.2 Sterilisation
After cleaning/disinfection, wrap the dismantled PARI PEP System and the
PEP tubing adapter if applicable in sterilisation packaging (disposable
sterilisation packaging, e.g., foil/paper sterilisation bags). The sterilisation
packaging must conform to DIN EN 868/ ISO 11607 and be suitable for
steam sterilisation. Then, sterilise the PARI PEP System using the following
sterilisation procedure:
Recommended procedure: Steam sterilisation
Sterilisation temperature: 121 °C (to be maintained for at least 20 min.) or
This procedure has been validated according to DIN EN 554/ISO 11134 as
well as DGKH guidelines for the validation and routine monitoring of sterilisa-
tion processes using damp heat for medical devices.
Storage
Store the sterilised PARI PEP System in a dry, dust-free location away from
sources of contamination.
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132 °C/134 °C (to be maintained for at least
5 min.)
max. 137 °C.