31 DePuy Synthes User Manual Small Battery Drive II
Care and Maintenance
General Information
sheet. Do not use a cleaning aid that can damage the
surface of instruments such as steel wool, abrasive
cleaners or wire brushes. Please refer to Cleaning and
Disinfection section of user manual for more
information about clinical reprocessing of the Small
Battery Drive II system.
•
Do not use pointed objects for cleaning.
•
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 contact
with the following materials: stainless steel,
aluminum, plastic and rubber seals. Do not use
saline, environmental disinfection (including
chlorine solutions) or surgical antiseptics (such as
iodine- or chlorhexidine-containing products).
Notes:
•
The clinical processing instructions provided have
been validated by Depuy Synthes for preparing a non-
sterile Depuy Synthes medical device; these
instructions are provided in accordance with ISO
17664 and ANSI/AAMI ST81.
•
Consult the national regulations and guidelines for
additional information. In addition, compliance with
internal hospital policies and the procedures and
recommendations of manufacturers of detergents,
disinfectants and any clinical processing equipment
is additionally required.
•
Cleaning Agent Information: Depuy Synthes used the
following cleaning agents during validation of these
reprocessing recommendations: neutral pH
enzymatic detergents (e. g. Steris Prolystica 2X
Concentrate Enzymatic Cleaner 1/8 oz. per gallon).
These cleaning agents are not listed in preference
to other available cleaning agents which may
perform satisfactorily.
•
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 instructions
provided should be properly evaluated for
effectiveness and potential adverse consequences.
Power tool units 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 instruments.
Gentle care and maintenance with proper lubrication can
substantially increase the reliability and life of the system
components.
Depuy Synthes power tools must be serviced and inspected
annually by the original manufacturer or an authorized site.
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 Small Battery Drive II Care and
Maintenance Chart.
Warnings:
•
Before first and every use and prior returning for
service power tools and their accessories/
attachments, excluding the battery, have to be run
through the complete repro cessing procedure.
Protective covers and films must be fully removed
before sterilization.
•
Cannulations, unlocking sleeves and other narrow
sites require special attention during cleaning.
•
Never immerse the handpiece, batteries, battery
casing or attachments in aqueous solutions or in an
ultrasonic bath.
•
Do not use pressurized water as this will cause
damage to the system.
•
The battery must never be autoclaved, washed,
rinsed or dropped. This would destroy the battery
with possible secondary damage.
•
The aseptic transfer is detailed in chapter “Use”.
Alternatively for the Li-Ion battery 532.103 follow the
guidelines provided in the STERRAD/V-PRO
sterilization guide. No other sterilization methods
are allowed.
Precautions:
•
Cleaning agents with a used dilution pH of within
7–9 are recommended. Highly alkaline conditions
(pH > 10) can damage components and devices, such
as aluminum materials, titanium and its alloys,
plastics or compound materials. The use of such
cleaners should be subject to the data regarding
material compatibility in the corresponding data
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