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

3.

Product Information

3.1. Intended Use

The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electro-
magnetic Navigation Unit and intended for controlling of the hardware of the navigation
unit.
WARNING
– The product may only be used for its intended purpose and in accordance with the fol-
lowing manual, as well as the applicable, current version of the Stryker ENT Navigation
System manual. The manual is part of the product and must therefore be accessible to
personnel at all times. It must be handed over to subsequent owners or users.
– Do not use the product if there are medical or clinical reasons for not doing so. The
product may only be used if the surgery could also be performed conventionally
– Only combine the navigation software with the compatible components listed in the For
Use With section of this manual.
– Unauthorized modifications of the product are forbidden for safety reasons.

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

3.3. Contraindications

None known.
EN Product Information | 8/21