fiagon E 01 1905 Instructions For Use - Page 2

Browse online or download pdf Instructions For Use for Adapter fiagon E 01 1905. fiagon E 01 1905 4 pages. Flexarm adapter for navigation sensor for side rails 25 x 10 mm

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Instructions for Use

General information

The Flexarm Adapter, hereafter related to as Navigation Sensor Flexarm, is a product variant of navigation

sensor which is mountable to rails 25x10 mm. The navigation sensor is a part of the Fiagon Navigation System

produced by Fiagon GmbH.

CAUTION: Read the instructions for use carefully before using the Navigation Sensor Flexarm. To

ensure proper use of the product read the manual of the Fiagon Navigation System.

CAUTION: Before using it, the Navigation Sensor Flexarm must be cleaned according to the

cleaning instructions. The navigation sensor is not sterilizable.

Indications for Use / Field of application

The application of the navigation sensor is limited to the indications for use described here.

The Navigation Sensor Flexarm is connected to and used with the Fiagon Navigation Unit. The devices are

components of the Fiagon Navigation System, which is intended as an aid for precisely locating anatomical

structures in either open or percutaneous procedures. The Fiagon 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, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR

based model of the anatomy.

The Fiagon Navigation System and its components are intended for use by healthcare professionals

(physicians) only. In addition, the users must receive training. The operator, i.e., the person or facility that is

responsible for the use and service of the system, must ensure that all users of the system receive an

adequate briefing in accordance with valid laws and regulations. An operator is anyone who uses the system.

The instructions for use of the Fiagon Navigation System describe the proper use of the entire system in detail.

The Navigation Sensor Flexarm is mounted rails 25 x 10mm, to create an electromagnetic field in the surgical

area.

CAUTION: The Navigation Sensor Flexarm may only be used if the safety instructions of the

Fiagon Navigation System and other connected devices have been followed.

Compatible Devices

The Navigation Sensor Flexarm can be mounted to rails of the following dimensions:

Rail: 25 x 10 mm

Device description

The Navigation Sensor Flexarm consists of a navigation sensor and an articulating arm with clamp for rails (25

x 10 mm). The navigation sensor creates the surgical navigation workspace.

Products

Fiagon GmbH

E 01 1905

DocumentID

Version

DOC-18-00044

2.00.0000

Date

2 / 4

Apr-2018