• Effectiveness of sterilization equipment or sterilization
processes are directly dependent upon numerous factors
beyond DePuy Synthes Power Tools control including
among other things; sterilization means, processes and
wrapping techniques employed, brand, model and condition
of sterilization equipment, care and maintenance techniques
employed and operator knowledge and experience.
• DePuy Synthes Power Tools cannot anticipate all possible
equipment, processes and/or conditions that may be
encountered. The suggested operation conditions are to
be considered as a starting point for determination of the
overall process capability, without regard for type or condition
of equipment used or methods, techniques or practices
employed by user. Use of proper sterilization indicator
devices is strongly recommended. It is recommended that
a drying cycle be included to avoid possible adverse effects
caused by exposure to condensation.
• 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").
Warning: All Instrument System components returned for servicing
or repair should be properly cleaned and sterilized as applicable
prior to shipping.
Warning: Transmissible Spongiform Encephalopathies
(TSE)
DePuy Synthes Power Tools will not authorize or accept the return
of products that directly contact patients or are contaminated
with a patient's body fluids who is suspected or confirmed with a
Transmissible Spongiform Encephalopathies/ Creutzfeldt-Jakob
Disease (TSE/CJD) diagnosis. DePuy Synthes Power Tools
recommends that all Anspach products used on a patient confirmed
with a TSE/CJD diagnosis be incinerated. Anspach dissection
tools used on a patient suspected of TSE/CJD diagnosis must be
incinerated.
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