background image

3

Instructions for Use

Copyright © 2018

Products

DocumentID

Version

Date

3 / 4

Fiagon GmbH

E 01 1905

DOC-18-00044 2.00.0000 Apr-2018

  Mounting of Navigation Sensor Flexarm

To attach the

Navigation Sensor Flexarm

 to the rail of 25 x 10 mm please follow the installation steps:

I. 

Attach the rail clamp of the device to an appropriate position on the rail.

II. 

Fix the clamp firmly with the screw.

III. 

Adjust the navigation sensor to the surgical area
and fix its position by tightening the articulating
arm`s knob.

IV. 

Insert the plug of the sensor into the appropriate socket “sensor” (metal socket) on the navigation
unit. Note that the 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 parts of the sensor must not be sterilized.

Clean the

Navigation Sensor Flexarm

 by hand and disinfect using an aldehyde-free disinfectant.

CAUTION:

Do not immerse the sensor, or parts of the sensor in the disinfectant or cleaning agent

  Preventive Maintenance Instructions

Maintenance is done by authorized personnel only. Recommended maintenance period is 1 year and includes
accuracy testing according to a described procedure.

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 ...

Reviews: