DrillSaw Mini 300™ System
User’s Guide
DFU-0223-2 Rev. 0
Page 28
6
6
.
.
0
0
Sterilization
Sterilization is to be performed following cleaning, disinfection, and sterile packaging prior
to use.
After sterilization in the autoclave, let the accessory device cool down slowly.
NEVER force the cooling of the handpiece or accessories. This will damage the
electronic components and seals.
Place all the components in the instrument tray. While you may use filtered
trays, it is recommended that you use one of the Arthrex approved instrument
trays, for example: AR-300C or AR-300C-G. If you are using a filtered tray,
please observe the manufacturer’s recommendations for that filtered tray.
Packaging should be completed utilizing a pouch or wrap which conforms to the
recommended specifications for steam sterilization as outlined below. If a wrap is
utilized, it should be completed following AAMI double-wrap or equivalent
guidelines with an appropriate wrap (cleared by the FDA or the local governing
body).
Only Arthrex devices should be included in the trays. These validated instructions
are not applicable to trays that include devices not intended to be used with Arthrex
trays.
6.1
Approved Sterilization
Local or national specifications should be followed where steam sterilization
requirements are stricter or more conservative than those listed in the table below.
Sterilizers vary in design and performance characteristics. Cycle parameters and the
load configuration should always be verified against the sterilizer manufacturer’s
instructions
RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type
Minimum Exposure
Temperature
Minimum Exposure
Time
Minimum Drying
Time
Pre-Vacuum
270°F (132°C)
4 minutes
30 minutes
* Caution: To maintain the highest possible level of performance and reliability on
handpieces and attachments, the drying time should be run every sterilization
cycle. Operating a handpiece or attachment that has not cooled and dried
sufficiently may also decrease product reliability and/or performance.
Note: Immediate-use (flash) steam sterilization should only be used as an
emergency procedure. Refer to AAMI ST79 for further instructions and limitations.