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Instructions for Use

Copyright © 2018

Products

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Fiagon GmbH

E 01 1905

DOC-18-00044 2.00.0000 Apr-2018

Product:

E 01 1905 Flexarm Adapter for Navigation Sensor

For side rails 25 x 10 mm

NOTE:

 The Flexarm Adapter is only to be used with the

Fiagon Navigation Sensor (A 01 100)

Manufacturer:

Fiagon GmbH
Neuendorfstraße 23b
D -16761 Hennigsdorf
Germany
Tel:  +49 3302 20121 10
Fax: +49 3302 20121 15
info@fiagon.de

For US market only. This document is intended to provide information to an audience of the US.

Explanation of symbols

Manufacturer

Date of manufacture

Reference number/Catalogue number

Serial number

Follow the instructions for use

Marking of conformity to the European Medical Device Directive 93/42/EEC (MDD).

Caution

Recommended storage tempe15°C to +35°C

Recommended storage humidity 30% to 75% without condensation

Recommended storage air pressure 700 hPa to 1060 hPa

This is the general warning sign. It is used to alert the user to potential hazards. All safety
messages that follow this sign shall be obeyed to avoid possible harm.

Federal law (USA) restricts this device to sale by or on order of a physician.

Summary of Contents for E 01 1905

Page 1: ...nded to provide information to an audience of the US Explanation of symbols Manufacturer Date of manufacture Reference number Catalogue number Serial number Follow the instructions for use Marking of conformity to the European Medical Device Directive 93 42 EEC MDD Caution Recommended storage temperature 15 C to 35 C Recommended storage humidity 30 to 75 without condensation Recommended storage ai...

Page 2: ...y 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 T...

Page 3: ... red marking on the plug is in the 12 o clock position CAUTION Using too much force while trying to plug in the sensor cable in a different position may cause damage to the plug and or the socket After usage disassembling For disassembling please perform installation steps in reverse order Cleaning instructions The Navigation Sensor Flexarm is a reusable component CAUTION The navigation sensor or ...

Page 4: ... condensation Air pressure 700 hPa to 1060 hPa Storage conditions Protected against dust moisture and recontamination Recommended storage temperature 15 to 35 C Recommended storage humidity 30 to 75 without condensation Recommended air pressure 700 hPa to 1060 hPa Compatible sensor type Fiagon Navigation Sensor A 01 1000 Work space volume Electrical safety and EMC The Navigation Sensor Flexarm is ...

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