fiagon E 01 1905 User manual

1Instructions for Use
Copyright © 2018 Products DocumentID Version Date 1 / 4
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: [phone]
Fax: [phone]
[e-mail]
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 temperature +15°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.

2Instructions for Use
Copyright © 2018 Products DocumentID Version Date 2 / 4
Fiagon GmbH E 01 1905 DOC-18-00044 2.00.0000 Apr-2018
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 S
ensor
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.

3Instructions 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.

4Instructions for Use
Copyright © 2018 Products DocumentID Version Date 4 / 4
Fiagon GmbH E 01 1905 DOC-18-00044 2.00.0000 Apr-2018
Specifications
Item E 01 1905 Flexarm Adapter for Navigation Sensor
Dimensions (sensor) 200 mm x 200 mm x 71 mm (height x width x depth)
Weight 2,9 kg (without cable)
Operating conditions Temperature: +15°C to + 35°C, Humidity: 30% to 75% without condensation
Air pressure: 700 hPa to 1060 hPa
Transport conditions Temperature: +15°C to + 35°C,
Humidity: 30% to 75% without 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 a part of the Fiagon Navigation System and can only be used in
combination with the Fiagon Navigation unit. All electrical safety and EMC testing has been performed with
this combination. Please refer to the instructions for use of the Fiagon Navigation System for details and
tables.