Product Information; Intended Use; Indications For Use; Contraindications - Stryker ENT Bedienungsanleitung

3.

Product Information

WARNING
– The product may only be used for its intended purpose and in accordance with the
following user manual, as well as all current versions of the "Stryker ENT Navigation
System" manual.
– The user manual is part of the product and must be accessible to personnel at all times.
It must be handed over to subsequent owners or users.

3.1. Intended Use

The Electromagnetic Navigation Unit is intended as an aid for precisely locating anatomical
structures in either open or percutaneous procedures.

3.2. Indications for Use

The Stryker ENT Navigation System is indicated for any medical condition in which the
use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical
structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can
be identified relative to a CT- or MR-based model of the anatomy.
Example procedures include, but are not limited to the following ENT procedures:
● Transsphenoidal access procedures
● Intranasal procedures
● Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/
sphenoid explorations, turbinate resections, and frontal sinusotomies
● ENT-related anterior skull base procedures
WARNING
– Potential malfunction. Only use the system if the surgery also can be performed conven-
tionally. Otherwise, a second equivalent product should be available.
– During therapeutic use, it is necessary to ensure visual observation of the systemic
effects.
– Intra-operative live images processed by the system may be displayed with a delay. Dur-
ing applications that require real-time critical imaging, a second monitor must be used.
This must be directly connected to the real time-critical image source.

3.3. Contraindications

None known.
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