Air Pen Drive Instructions for Use DePuy Synthes 37
Care and Maintenance
Packaging, Sterilization and Storage
Packaging
Put cleaned, dry products into the proper places in the
Synthes Vario Case (68.000.020 or 68.000.030) or in the
Washing Basket (68.001.800). Additionally, use an ap-
propriate sterilization wrap or re-usable rigid container
system for sterilization, such as a Sterile Barrier System
according to ISO 11607. Care should be taken to protect
implants, and pointed and sharp instruments from con-
tact with other objects that may damage the surface or
the Sterile Barrier System.
Sterilization
Important:
Remove the Seal Nipple for Double
Air Hose for Air Pen Drive (05.001.091) and the
Protective Cap (05.001.086) from the Air Pen Drive
before sterilization. Disconnect the Synthes Dou-
ble Air Hose (519.510, 519.530 or 519.550) before
sterilization. Remove the seal nipple (519.596) of the
Dräger Double Air Hose (519.610, 519.630 or 519.650)
and the seal nipple (519.591 or 519.592) of the BOC/
Schrader Air Hose (519.511 or 519.531) before steril-
ization.
Synthes Air Pen Drive System may be resterilized using
validated steam sterilization methods (ISO 17665 or na-
tional standards). Synthes’ recommendations for packed
devices and cases are as follows.
Cycle type
Sterilization
exposure time
Sterilization
exposure temperature
Drying time
Saturated steam-forced
air removal (pre-vacuum,
minimum 3 pulses)
Minimum 4 minutes
Minimum 132 °C
20–60 minutes
Maximum 138 °C
Minimum 3 minutes
Minimum 134 °C
20–60 minutes
Maximum 138 °C
Dry times generally range from 20 to 60 minutes due to
differences in packaging materials (Sterile Barrier System,
e.g., wraps or re-usable rigid container systems), steam
quality, device materials, total mass, sterilizer perfor-
mance and varying cool-down time.
Precautions:
•
The Foot Switches should not be sterilized.
•
The following maximum values may not be ex-
ceeded: 138°C for a maximum of 18 minutes.
Higher values can damage the sterilized products.
•
After sterilization, the handpiece should only be
used again when it has cooled down to room tem-
perature.
•
Do not accelerate the cooling process.
•
Hot air, ethylene oxide, plasma and formaldehyde
sterilization are not recommended.
Storage
Storage conditions for products labeled ”STERILE” are
printed on the packaging label. Packaged and sterilized
products should be stored in a dry, clean environment,
protected from direct sunlight, pests, and extremes of
temperature and humidity. Use products in the order in
which they are received (”first-in, first-out principle”),
taking note of any expiration date on the label.
