DrillSaw Highspeed 200™ User’s Guide
DFU-0225-2 Rev. 0 Page 46 of 58
7.2 Irrigation pump tubing
The tubing is supplied pre-packaged sterile, by EO sterilization. Do not
resterilize.
Sterile devices must be stored in the original unopened packaging, in a cool
place, away from moisture and should not be used after the expiration date.
All pump tubing is single use.
The irrigation pump tubing should be accepted only if the factory packaging and
labeling arrive intact.
Contact Customer Service if the sterile irrigation package has been opened or
altered.
7.3 Transmissible Spongiform Encephalopathy Agents
It is outside the scope of this document to describe in detail the precautions that
should be taken for Transmissible Spongiform Encephalopathy (TSE) Agents.
The agents for transmission of Creutzfeldt-Jakob disease are believed to be
resistant to normal disinfection and sterilization processes. Therefore, the normal
processing methods of decontamination and sterilization as described above may
not be appropriate where CJD transmission is a risk.
In general, the tissues that come into contact with orthopedic surgical
instruments are those of low TSE infectivity. However, take particular
precautions when handling instruments that have been used on known,
suspected, or at-risk patients.
References:
ANSI/AAMI ST79: Good Hospital Practice: Steam sterilization and sterility
assurance.
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