Do not store or transport Power Units haphazardly in a
box or drawer where they may short-circuit each other or
be short- circuited by other metal objects. This can dam-
age the Power Unit and generate heat, which can cause
burns.
Please note that if the UNIUM Power Unit (05.001.602)
is damaged, it cannot be transported by aircraft cargo.
Please refer to the chapter "Repairs and Technical
Service" to see when a Power Unit can be considered to
be damaged.
Please refer to the chapter "Environmental Conditions"
to see both transport and storage conditions.
Servicing
▲ WARNING:
•
This device requires regular maintenance service, at
least once a year, in order to maintain its safety and
functionality. This service has to be performed by the
original manufacturer or an authorized site.
Warranty and Liability
The warranty for the tools and accessories does not
cover normal wear or damage of any kind resulting from
improper use, improper reprocessing and maintenance,
damaged seal, use of non-Synthes Cutting Tools and
Lubricants or improper storage and transport. The manu-
facturer excludes liability for damage resulting from
improper use, neglected or unauthorized maintenance or
servicing of the tool. In such cases the product will
no longer be accepted or repaired by DePuy Synthes.
For further information on the servicing, warranty and
return policy please contact your local DePuy Synthes
Office.
General Warnings and Precautions
▲ WARNINGS:
•
For safety reasons, please read the Instructions for Use
carefully before using the device.
•
Do not use any device if the packaging is damaged or if
there is any apparent damage to the device.
•
Always wear personal protective equipment (PPE)
including safety goggles when handling with the device.
•
To avoid injuries, always switch OFF the handpiece
before every manipulation (e.g. inserting/removing the
power unit, attachments and/or cutting tools) and
before placing it back down.
•
Should the handpiece fall on the floor and have visible
damage, do not use and send it to the DePuy Synthes
Service Center. Using a damaged device may cause
harm to the user or patient.
•
If a product falls on the floor, fragments may break off.
This may cause harm to the patient or user due to:
– loose or sharp fragments.
– unsterile fragments potentially entering the sterile
field or coming into contact with the patient.
•
Synthes Devices 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 De vices, etc.) can
aid in locating the fragments and/or components of the
device.
▲ Precautions:
•
After inserting an attachment, a top for sternum or a
cutting tool, always check that it is properly engaged
by pulling on it gently.
•
Avoid changing the position of the mode switch while
the handpiece is operating. Should this happen, release
the trigger, turn the mode switch to ON or FWD ONLY
and press the trigger again to restart the device.
•
Do not grasp or touch any rotating or moving
component while the handpiece is operating.
•
Do not apply excessive pressure with an accessory,
such as bending or prying. Excessive pressure may
bend or fracture the accessory and result in tissue
damage, loss of tactile control, and/or the ejection of
accessory fragments at a high velocity.
•
The handpiece must only be operated with a fully
charged Power Unit. Therefore, ensure that the Power
Unit is fully charged prior to usage. We recommend
installing the Power Unit just before use in order to
prevent unwanted discharge if the handpiece is not in
the OFF mode. Furthermore, it is recommended that
the Power Unit is placed into the charger immediately
after surgery.
•
Should the device have corroded parts, discontinue
use and send it to the DePuy Synthes Service Center.
•
Only use the Universal Battery Charger II (05.001.204)
to charge the UNIUM Power Unit. Using a charger that
does not originate from Synthes can damage the
UNIUM Power Unit.
•
United States Federal law restricts this device to sale
by or on order of a physician or other licensed
healthcare provider.
Introduction
General Information
10
Instruction for Use • UNIUM
™
