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6.3 STERILIZATION
Sterilization may only be performed on handles that have already been cleaned and disinfected.
The sterilization of the blue sterile handle has been validated with the following mechanical
procedure and parameters:
Sterile handle packaged in paper/laminate
Sterilizer class B LISA 522, serial number 08-0794, W&H company
Sterilization process: Fractionated pre-vacuum process
Temperature: 134 °C
Holding time: 18 min.
Table. Sterilization
WARNING: ONLY FOR STEAM STERILIZATION!
If a sterilization process other than the one described is used, the suitability and basic
effectiveness of the process must be validated by the user.
6.4 VERIFICATION /DURABILITY
Before reuse, the handles must be checked for damage and replaced as necessary. The handles
are designed for 1000 reprocessing cycles and must be replaced every two years. Please refer
to the embossing on the top of the handle to determine the date of manufacture.
If the handles are used beyond the stated specifications (1000 cycles or 2 years), the
responsibility lies with the user. In this case, there is a risk that the handle will break
during operation and fragments could enter the operating area!
6.5 SIGNS OF MATERIAL WEAR
Material wear is normally the result of sterilization, disinfection and damage during use. After
sterilization/disinfection and use, inspect the light for corrosion, damaged surfaces, scratches,
sharp edges, breaks as well as contamination of the handle and sort out the damaged unit.
Critical areas such as the lamp head housing, handles, stands, joints, power supply units, power
connection must be inspected particularly carefully.
If there is visible material wear or damage even though the light is functioning, disconnect the
unit from the power supply and immediately contact the manufacturer/provider for service and
advice.
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