Care and Maintenance
General Information
Power Tools and attachments are frequently exposed 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 devices
and reduce the risk of malfunction or harm to the user
and patient.
Power Tools must be serviced and inspected at least
once a year by the original manufacturer or an authorized
site. Yearly maintenance will ensure that the equipment
maintains the highest standard of performance and will
prolong the life of the device. The manu facturer assumes
no warranty for damages arising from improper use,
neglected or unauthorized servicing of the tool. In such
cases the product will no longer be accepted or repaired
by DePuy Synthes.
A visual overview of the Care and Maintenance proce-
dures can be found on the UNIUM Care and Maintenance
Poster.
▲ WARNINGS:
•
Before first and every use, and prior to returning for
service, Power Tools and their accessories/ attachments
must be run through the complete reprocessing
procedure. Protective covers and films must be fully
removed prior to sterilization. Failure to follow the
reprocessing instructions may lead to infection.
•
Cannulations, unlocking sleeves and other narrow sites
require special attention during cleaning.
•
The UNIUM device is designed to be adequately
protected against water intrusion when exposed to
water jets in automated washers. Do not use excessive
water pressure when cleaning the cannulations. Follow
the instructions of the manufacturers' automated
washers. Never immerse the handpieces, power units
and attachments in aqueous solutions or in an ultra-
sonic bath.
•
The Power Unit and Adapter for UBC II must never be
autoclaved, washed, rinsed, immersed or dropped.
This will destroy them with possible secondary
damage.
•
Cleaning agents with a pH of within 7–9.5 are
recommended. Highly alkaline conditions (pH > 10) can
damage components and devices made of materials
such as aluminum, titanium and its alloys, plastics and
compound materials. The use of such cleaners should
be subject to the data regarding material compatibility
in the corresponding data sheet.
Do not use a cleaning aid that can damage the surface
of devices such as steel wool, abrasive cleaners or wire
brushes.
•
Follow the neutral pH enzymatic or mild alkaline
detergent Instructions for Use for correct dilution/
concentration, temperature and water quality. The
chemical quality of the water used during reprocessing
can impact device safety. Facilities should meet the
recommended water quality requirements for device
reprocessing in accordance with local guidance (such
as AAMI TIR 34 “Water for the reprocessing of
medical devices”) and this Instructions for Use. Devices
should be cleaned in a fresh, newly-made solution.
•
Do not use saline, environmental disinfection (in cluding
chlorine solutions) or surgical antiseptics (such as
iodine- or chlorhexidine-containing products).
•
Detergents used on the products will be in contact
with the following materials: stainless steel, aluminum,
plastic, and rubber seals.
Unusual Transmissible Pathogens
▲ WARNING:
Surgical patients identified as at-risk of Creutzfeldt- Jakob
disease (CJD) and related infections should be treated
with single-use devices. Dispose of instruments, Power
Tools and attachments used or suspected of having been
used on a patient with CJD after surgery by incineration
and/or follow current national recommendations.
▲ Precautions:
•
Clean and lubricate the triggers on the handpiece by
following the care and maintenance instruc tions in the
UNIUM Instructions for Use.
•
Do not use sharp or pointed objects for cleaning.
•
The parameters listed are only valid for properly
installed, maintained, calibrated and compliant
reprocessing equipment in accordance with standards
such as the ISO 15883 and ISO 17665 series.
•
Consult national regulations and guidelines for
additional information. Furthermore, compliance with
internal hospital policies and procedures and
recommendations of manufacturers of deter gents,
disinfectants, and any clinical processing equipment is
required.
27
UNIUM
™
• Instruction for Use
