Safety Measures During Use
It is recommended to have a back-up UNIUM Handpiece
readily available to use during surgery, as the potential for
technical problems can never be completely avoided.
Do not use any visibly damaged devices.
Do not use this equipment in the presence of oxygen,
nitrous oxide or a mixture consisting of flammable
anesthetic and air. To ensure proper operation of the sur-
gical medical device, only use original accessories.
For the surgical medical device to function properly, it is
recommended that it is cleaned, disinfected and main-
tained after each use in accordance with the process de-
fined in the “Care and Maintenance” section. Compliance
with these specifications can considerably extend the
service life of the device and reduce the risk of malfunc-
tion or harm to user and patient.
To reach the specified performance, only Synthes cutting
tools must be used because they are optimized to meet
the specific requirements of the device. Non-Synthes
cutting tools’ compatibility has not been tested and can
reduce the lifetime of the device. The only exception are
the saw blades with a DePuy Synthes saw coupling man-
ufactured by Gebr. Brasseler GmbH & Co. KG. In this
case, Gebr. Brasseler is the legal manufacturer and
DePuy Synthes the exclusive distributor.
▲ WARNINGS:
•
Cutting tools must be cooled with irrigation fluid to
prevent heat necrosis. For this purpose, irrigate
manually.
•
Check used cutting tools after every use for wear and/
or damage and replace them if necessary.
▲ Precaution:
It is recommended to use new cutting tools for every
surgery to prevent the device from heating up as a result
of reduced cutting per formance.
Used cutting tools present the following risks:
•
Necrosis due to excess heat.
•
Longer cutting time due to reduced performance of the
cutting tool.
•
Infection caused by residue.
The user of the product is responsible for proper use of
the equipment during surgery.
Check proper operation of the Power Tool before using
it on the patient. To prevent overheating, always respect
the specified Duty Cycles described in this manual.
For important information regarding electromagnetic
compatibility (EMC) please refer to the corresponding
“Electromagnetic Compatibility” section.
Both handpieces are classified as type BF against electri-
cal shock and leakage current and are certified according
to 60601-1 Medical Electrical Equipment.
Accessories Required
Please refer to the “Ordering Information” section for an
overview of the articles of the UNIUM Portfolio.
Special accessories such as cleaning brushes (519.400,
519.40* and 532.024) and Synthes Special Oil (519.970,
519.97*) are available for cleaning and servicing device.
Only Synthes Special Oil (519.970, 519.97*) must be used
to lubricate the Power Tools and attachments. Lubricants
with other compositions may cause jamming, have a toxic
effect or have a negative impact on the sterilization re-
sults. Only lubricate the Power Tool and the attachments
when clean.
It is recommended to use the specifically designed
UNIUM Washing and Sterilization Baskets (68.001.650,
68.001.651, 68.001.652, 68.001.653 and 68.001.654) for
automated cleaning, sterilization and storage of the
device. Further information can be found in the “Care and
Maintenance” section of this document.
Latex Information
Not made with natural rubber latex.
Combination of Medical Devices
Use UNIUM Handpieces in combination with attach-
ments, adapters, cutting tools and the Universal Battery
Charger II as specified in this document.
Synthes has not tested the compatibility with devices
produced by other manufacturers and assumes no liability
when used with an unauthorized device.
Storage and Transport
Only use the original packaging for dispatch and transport
as damage may occur otherwise. If the original packaging
materials are no longer available, please contact your lo-
cal DePuy Synthes Representative.
The Power Unit is classified as a “Li-Ion battery contained
in equipment” according to the International Air Transport
Association (IATA) regulation UN 3481 PI 967. Please en-
sure that the packaging and documentation requirements
for shipping a Power Unit are followed.
Introduction
General Information
* available in USA only.
9
UNIUM
™
• Instruction for Use
