Air Power Line II Instructions for Use
DePuy Synthes
25
Unusual Transmissible Pathogens
Surgical patients identified as at-risk for Creutzfeldt- Jakob
disease (CJD) and related infections should be treated with
single-use instruments. Dispose of instruments, power tools
and attachments used, or suspected to have been used, on a
patient with CJD after surgery by incineration and/or follow
current national recommendations.
Notes:
– The clinical processing instructions provided have been
validated by Synthes for preparing a non-sterile Synthes
medical device; these instructions are provided in accor-
dance with ISO 17664 and ANSI/AAMI ST81.
– Consult national regulations and guidelines for additional
information. Furthermore, compliance with internal hospi-
tal policies and procedures and recommendations of man-
ufacturers of detergents, disinfectants, and any clinical
processing equipment is additionally required.
– Cleaning Agent Information: Synthes used the following
cleaning agents during validation of these reprocessing
recommendations. These cleaning agents are not listed in
preference to other available cleaning agents which may
perform satisfactorily – neutral pH enzymatic detergents
(e.g. Steris Prolystica 2X Concentrate Enzymatic Cleaner).
– It remains the responsibility of the processor to ensure
that the processing performed achieves the desired result
using the appropriate, properly installed, maintained and
validated equipment, materials and personnel in the pro-
cessing unit. Any deviation by the processor from the in-
structions provided should be properly evaluated for ef-
fectiveness and potential adverse consequences.
