4.2
Machine Cleaning and Disinfection
NOTICE
Risk of damage to the bipolar forceps!
When choosing the disinfector, make sure that
the disinfector has a proven efficacy (e. g. DGHM or FDA-approved or CE label according
•
to DIN EN ISO 15883),
the program used is suitable for the instrument and includes a sufficient number of
•
washing cycles,
only sterile or germ-free (10 germs/ml max.) and endotoxin-free (0.25 endotoxin
•
units/ml) water (e. g. purified water / highly purified water) is used for the final rinse,
the air used for drying is filtered, and
•
the disinfector is maintained and checked on a regular basis.
•
Observe the criteria mentioned in chapter 4.1 "Preparation for Cleaning", page 25, when
choosing the cleaning system that is used.
Insert instruments in the disinfector. Make sure the instruments do not touch.
4.2.1
Validated Program Sequence
Pre-rinsing
Rinsing temperature: 10±2 °C (50±36 °F)
Soaking time: 1 min
Cleaning
Cleaning temperature: 70±2 °C (158±36 °F)
Soaking time: 5 min
Cleaning detergent: deconex ALKA One-x, concentration 0,5 % (5 ml/l)
Post-rinsing
Rinsing temperature: 10±2 °C (50±36 °F)
Soaking time: 1 min
Thermal disinfection
Disinfection temperature: 90±2 °C (194±36 °F)
Soaking time 5 min
Inspect and pack the instruments immediately after removal from the disinfector, if necessary
after additional post-drying at a clean place.
26
Instructions for Use
Bipolar Forceps NON-STICK
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Revision 3