Care and Maintenance
General Information
Power tool units and attachments are frequently ex-
posed to high mechanical loads and shocks during
use and should not be expected to last indefinitely.
Proper handling and maintenance help extend the
useful life of surgical instruments.
Gentle care and maintenance with proper lubrication
can substantially increase the reliability and life of
the system components.
DePuy Synthes recommends annual servicing and
inspection by the original manufacturer or its exclu-
sive sales outlets. Yearly maintenance will ensure
that the equipment maintains the highest standard of
performance and will prolong the life of the system.
The manufacturer assumes no warranty for damages
arising from improper use, neglected or unauthorized
servicing.
For more information about Care and Maintenance,
please refer to the Battery Power Line II Care and
Maintenance Poster (038.000.317).
Notes:
–
Reprocessing must be performed immediately
after each use.
–
Cannulations, unlocking sleeves and other nar-
row sites require special attention during clean-
ing.
–
Cleaners with a pH of 7–9.5 are recommended.
The use of cleaners with higher pH-values can –
depending on the cleaner – cause dissolution of
the surface of aluminum and its alloys, plastics
or compound materials. The use of such clean-
ers should be subject to the data regarding ma-
terial compatibility in the corresponding data
sheet. At pH values higher than 11, the surface
of stainless steel can be affected.
For detailed information about material compati-
bility, refer to the document “Important Informa-
tion” at www.synthes.com/reprocessing. Please
refer to the chapter “Material Compatibility of
Synthes Instruments in Clinical Processing”.
Concerning the clinical reprocessing of the BPL
II system please refer to the following section of
this document.
–
Follow the enzymatic cleaner instructions for use
for correct dilution concentration, temperature
and water quality. Devices should be cleaned in
a fresh, newly-made solution.
–
Detergents used on the products will be in con-
tact with the following materials: stainless steel,
aluminum, plastic, and rubber seals.
–
Never immerse the handpiece, batteries, bat-
tery casing or attachments in aqueous solu-
tions or in an ultrasonic bath or use pressur-
ized water as this will cause damage to the
system.
–
DePuy Synthes recommends using new sterile
cutting tools for each operation. Refer to “Clinical
Processing of Cutting Tools” (036.000.499) for
detailed clinical processing instructions.
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 DePuy Synthes for pre-
paring a non-sterile Synthes medical device;
these instructions are provided in accordance
with ISO 17664:2004 and
ANSI / AAMI ST81:2004.
–
Consult national regulations and guidelines for
additional information. Furthermore, compliance
with internal hospital policies and procedures
and recommendations of manufacturers of de-
tergents, disinfectants, and any clinical process-
ing equipment is additionally required.
–
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 processing unit.
Any deviation by the processor from the instruc-
tions provided should be properly evaluated for
effectiveness and potential adverse conse-
quences.
Battery Power Line II Instructions for Use
DePuy Synthes
39
Summary of Contents for BPL II
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