7
1. Introduction
may use the surgical unit.We have based our development
and design of the Osscora surgial set on the “physician”
target group.
Responsibility of the manufacturer
Cochlear Bone Anchored Solutions AB can only accept
responsibility for the safety, reliability and performance
of the Osscora surgical set when there is compliance with
the following directions:
• The Osscora surgical set must be used in accordance
with these Instructions for Use.
• The Osscora surgical set has no components which
can be repaired by the user. Assembly, modifications
or repairs must be undertaken by authorised personnel
only.
• The electrical installation at the premises must comply
with the regulations applicable in your country.
• Unauthorised opening of the equipment invalidates all
claims under warranty and any other claims.
For your safety and the safety of your patients
These Instructions for Use explain how to use your Cochlear
product. However, we must also warn against possible
hazardous situations. Your safety, the safety of your team,
and of course, the safety of your patients is of paramount
importance to us.
It is therefore essential to read the safety notes on pages
8 to 11.
Intended use
Osscora surgical set with contra-angle handpiece is intended to
be used for Baha
®
and/or Vistafix
®
surgery including:
• Dermatome use
• Drilling
• Thread cutting
• Implant placement and removal
Qualification of the user
Osscora surgical set with contra-angle handpiece is intended to be
used in operating rooms and to be used by trained surgeons and
operating room staff.
Only suitable qualified medical, technical and specialist trained staff
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