Cochlear Osscora 91051 - 1. Introduction; Safety and Patient Well-being; Manufacturers Responsibility

English
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1. Introduction
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 5 to 7.
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
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.
Osscora surgical set is CE-marked according to Medical Device
Directive 93/42/EEC.