4 DePuy Synthes User Manual Small Battery Drive II
Unusual Transmissible Pathogens
Warning:
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.
Locating of the instrument or fragments of
instruments
Warning:
Depuy Synthes instruments are designed
and manufactured to perform within the scope of
their intended use. However, if a power tool or
accessory/attachment breaks during use, a visual
inspection or a medical imaging device (e. g. CT,
Radiation Devices, etc.) can aid in locating the
fragments and/or components of the instrument.
Treatment before device is used
Warning:
Before first and every use and prior to re-
turning for service, power tools and their accessories/
attachments, excluding the battery, have to be run
through the complete reprocessing procedure.
Protective covers and films must be fully removed
before sterilization.
Safety instructions
It is recommended that an alternative system is available to
use during application, as technical problems can never be
completely ruled out.
Precaution:
Do not use any component if damage is
apparent.
Warnings:
•
For safety reasons, please read the IFU carefully
before using Small Battery Drive II.
•
Do not use any component if the packaging is
damaged.
•
Do not use this equipment in the presence of
oxygen, nitrous oxide or a mixture consisting of
flammable anesthetics and air.
•
To ensure proper operation of the surgical medical
device, only use Depuy Synthes original
accessories.
For the surgical medical device to function properly, Depuy
Synthes recommends that it is cleaned, disinfected and
serviced after each use in accordance with the process
defined in the “Care and Maintenance” section.
Compliance with these specifications can considerably
extend the service life of the tool and reduce the risk of
malfunction or harm to the user and patient. Only use
Depuy Synthes Special Oil (519.970) to lubricate the tool.
We recommend using new Depuy Synthes cutting tools for
every surgical procedure. Efficiently working cutting tools
are the basis for successful surgery. Therefore, it is
mandatory to check used cutting tools after every use for
wear and / or damage and to replace them if necessary. We
recommend using new Depuy Synthes cutting tools for
every surgery. Cutting tools must be cooled with irrigation
liquid to prevent heat necrosis.
The user of the product is responsible for proper use of the
equipment during surgery.
Check proper operation of the tool before using it on the
patient. To prevent overheating, always respect the
specified Duty Cycles.
For important information regarding electromagnetic
compatibility (EMC), please refer to the chapter
“Electromagnetic Compatibility” in this manual.
The surgical medical device is classified as type BF against
electrical shock and leakage current. The tool is suitable for
use on patients in accordance with IEC 60601-1.
Accessories/Scope of delivery
The following components are essential to ensure proper
operation:
Handpiece (532.110)
Battery Casing (532.132)
Battery (532.103)
Sterile Cover (532.104)
Universal Battery Charger II (05.001.204)
At least one attachment of the system
Please refer to the end of these Instructions for Use for an
overview of the components of the system.
To reach the specified performance, only Depuy Synthes
cutting tools should be used. These are optimized to meet
the specific requirements of the tool. Non Depuy Synthes
cutting tools can considerably reduce the lifetime of the
system.
To charge the batteries only use the corresponding Depuy
Introduction
General Information
Summary of Contents for DePuy Synthes Small Battery Drive II
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