Johnson & Johnson DePuy Synthes Small Battery Drive II, Руководство пользователя

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44 DePuy Synthes User Manual Small Battery Drive II
Care and Maintenance
Packaging, Sterilization and Storage
Packaging
Put cleaned, dry products into their respective places in the
Depuy Synthes case. Additionally, use an appropriate
sterilization wrap or reusable rigid container system for sterili-
zation, such as a Sterile Barrier System according to ISO 11607.
Care should be taken in order to protect implants as well as
pointed or sharp instruments from contact with other objects
that may damage the surface or the Sterile Barrier System.
Sterilization
Note:
For the sterilization of the Small Battery Drive II
system, Depuy Synthes recommends the use of the
specifically designed Washing Basket (68.001.610). or the
Graphic Cases (06.550.060, 06.550.200 and 06.550.210)
Depuy Synthes Small Battery Drive II system must be
resterilized using validated steam sterilization methods (ISO
17665 or national standards). Depuy Synthes’
recommendations for packed devices and cases are as follows.
Cycle type
Prevacum Sterilization exposure time Sterilization exposure
temperature Drying time
Saturated steam-forced
air removal (pre-vacuum,
minimum 3 pulses) Minimum 4 minutes Minimum 132 °C
Maximum 138 °C 20–60 minutes
Minimum 3 minutes Minimum 134 °C
Maximum 138 °C 20–60 minutes
Drying times generally range from 20 to 60 minutes due
to differences in packaging materials (Sterile Barrier
System, e.g., wraps or reusable rigid container systems),
steam quality, device materials, total mass, sterilizer
performance and varying cool down time.
Warnings:
•
The aseptic transfer is detailed in chapter Use.
Alternatively for the Li-Ion battery 532.103 follow
the guidelines provided in the STERRAD/V-PRO
sterilization guide. No other sterilization methods
are allowed.
•
The following maximum values must not be
exceeded: 138 °C over a maximum of 18 minutes.
Higher values can damage the sterilized products.
•
Do not accelerate the cooling process as it will
damage the electronic components of the power tool
and could result in harm to the user and patient.
•
Hot air, ethylene oxide, plasma (except for battery
532.103) and formaldehyde sterilization are not
recommended.
•
Observe the packages prior to storage for visual
moisture or dampness and if found on or within
the pack, the product should be repackaged and
sterilized with an increased drying time.
•
The battery housing must be sterilized when open.