26
Instructions for Use
Copyright © 2020
DocumentID
Version
Date
26 / 33
Fiagon GmbH
DOC-19-00169 2
08-2020
EN / US
Notes for maintenance and service
10.1. Maintenance
There are no hardware and software components inside the housing of the Navigation Unit Cube4D which must
be maintained by the customer. Contact the manufacturer instantly if a problem with the Navigation System
occurs to repair the system.
The Navigation Unit Cube4D requires regular maintenance by the manufacturer and general routine checks by
the operator/user. The control involves performing safety tests and is required with a period of 12 months by the
manufacturer unless it is otherwise provided. These maintenance activities are necessary to allow for safe and
reliable use of the system.
All changes and/or repairs within the warranty period will be carried out exclusively by the manufacturer and
distributor or by authorized third parties.
There are no special instructions for maintaining Basic safety and essential performance regarding
electromagnetic disturbances.
After the warranty period has ended, we ask you to take precautionary measures in consultation with your
regional consultant regarding the execution of the maintenance activities. We provide special service contracts
for you.
Even if the operator does not execute the maintenance activities, he is responsible that all necessary
maintenance work has been carried out before using the Navigation System on a patient.
DANGER:
The Navigation System must not be operated if maintenance activities and checks are not
regularly carried out in compliance with the requirements and guidelines of applicable laws.
WARNING:
Maintenance work may only be carried out by qualified and authorized personnel
.
CAUTION:
Make sure that all necessary safety measures are taken into account during maintenance
work to prevent damage and injuries.
NOTE:
Fiagon recommends keeping a medical devices book for the repair and maintenance work
carried out. Take notes of relevant information regarding the type of work, the company that carried
out the work, and other important information.
10.2. Routine checks
Each time before using the device, check that the necessary maintenance work has been carried out (medical
devices book).
Check the system for functionality before using it.
Check the connection cables of the system routinely for damages of any kind. If needed, ask for replacement
parts.
Check the system components for external damages.
10.3. Updates
Updates of this instruction manual will be published as soon as updated information or corrections are available.
When purchasing a new software version, the supplied instruction manual corresponds to this new version.
CAUTION
: The Navigation System must not be used without a valid instruction manual. The instruction
manual corresponds to this new version.
NOTE:
For information on current hardware and software products, please visit the manufacturer's
website:
