the implant devices rather than the instruments. Specific
contraindications for the implants can be found in the
respective Synthes Implant Instructions for Use.
Patient Target Group
Synthes manufactures surgical instruments intended to
prepare the site and aid in implantation of Synthes Im-
plants. The patient target group is based upon the implant
devices rather than the instruments. Specific patient tar-
get group for the implants can be found in the respective
Synthes Implant Instructions for Use.
Expected Clinical Benefits
No direct clinical benefit is expected from these devices
as this benefit is expected to be derived from the associ-
ated surgery or implants.
Indirect clinical benefits may be achieved by consistent
torque and adjustable speeds by facilitating procedural
steps and/or application of implants.
Potential Adverse Events
As with all major surgical procedures, risks, side effects
and adverse events can occur. The following potential
adverse events can occur:
•
Infection
•
Adverse Tissue Reaction
•
Injury to Patient
•
Injury to User
Unusual Transmissible Pathogens
▲ WARNING:
Surgical patients identified as at-risk of Creutzfeldt-Jakob
disease (CJD) and related infec tions should be treated
with single-use devices. Dispose of instruments, Power
Tools and attach ments used or suspected of having been
used on a patient with CJD after surgery by incineration
and/or follow current national recommendations.
Required Reprocessing Before Device Is Used
▲ 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.
•
Always follow the specified cleaning and disinfection
steps for the Power Unit, Adapter for UBC II and UBC II
as described in the Instructions for Use.
Introduction
The UNIUM Portfolio consists of the following items:
•
Modular handpiece
•
Reciprocating Saw handpiece
•
Power Unit
•
A range of specially designed attachments and
accessories.
Important note for medical professionals and operating
room staff: These Instructions for Use do not include all
of the information necessary for selection and use of
the devices.
In addition, please read the following documents carefully
before using UNIUM:
•
Universal Battery Charger II Instructions for Use
•
Cutting Tools Instructions for Use
•
Care and Maintenance Poster UNIUM
•
Brochure titled "Working with the Radiolucent Drive"
When working with implants, ensure you are familiar with
the appropriate technique by referring to the Synthes
Implant Instructions for Use. The manufacturer is not
responsible for any complications arising from incorrect
diagnosis, choice of incorrect implant, incorrectly com-
bined implant components and/or operating.
Intended Use
UNIUM is a battery-driven Power Tool intended for use in
traumatology and orthopedic surgery which may include
drilling, reaming, burring, screwing, tapping, sawing and
setting pins and wires.
Intended User
UNIUM is intended to be used by qualified health care
professionals, e.g. surgeons, operating room staff,
and individuals involved in preparation of the device.
Indications
UNIUM does not have any product specific indications.
Synthes manufactures surgical instruments intended
to prepare the site and aid in implantation of Synthes
Implants.
The indications are based upon the implant devices rather
than the instruments. Specific indications for the implants
can be found in the respective Synthes Implant Instruc-
tions for Use.
Contraindications
UNIUM does not have any product specific contra-
indications. Synthes manufactures surgical instruments
intended to prepare the site and aid in implantation of
Synthes Implants. The contraindications are based upon
Introduction
General Information
8
Instruction for Use • UNIUM
™
