10
Instructions for Use
Copyright © 2020
DocumentID
Version
Date
10 / 33
Fiagon GmbH
DOC-19-00169 2
08-2020
EN / US
Cube VirtuLink - multiport extention cable
(included in 8 sensor channel models -HD/8 and 4K/8)
1.5. Qualification of the user
The Navigation System may only be used by healthcare professionals (physicians). Also, the users receive
training that has been authorized by the manufacturer and distributor before using the system safely and
efficiently on the patient. The operator, i.e., the person or facility that is responsible for the use and service of
the Navigation System, must ensure that all users of the Navigation System receive an adequate introduction
into the Navigation System per valid laws and regulations. An operator is everyone who is using the Navigation
System.
NOTE:
The information provided by the Navigation System is intended to support the surgeon.
Nevertheless, the Navigation System cannot replace a detailed knowledge of anatomy. All procedures
and notes described herein do not release the user from his responsibility regarding the clinical ability
to judge and the clinical procedures
CAUTION
: Do not use the Navigation System if medical or clinical reasons contraindicate its use.
CAUTION:
Do not use the Navigation System if you have not received appropriate training for the safe
and efficient use of the Navigation System.
1.6. Patient Data Protection
HIPAA Privacy Rule Compliance: Users of the Fiagon Navigation System have the option of assigning a
password before system operation to prevent unauthorized access to individually identifiable health information.
NOTE:
To protect sensitive healthcare information, Fiagon strongly recommends applying a password
to operate the Navigation System.
1.7.
Cyber and information security
Fiagon strongly recommends to use anti-virus software and to keep the firewall settings of the Operating system
(Windows 10 professional) active (delivery settings). We recommend the use of the software Avira Antivirus
Premium 2013 (Avira Operations GmbH & Co. KG, Germany,
During installation of the Navigation System at your facility by Fiagon’s authorized personnel, we will inform
about the possibilities of security. The bringing into service routine includes the installation of the anti-virus
software along with the information updating it.
Connector to
Navigation unit
multi channel port
Patient Localizer/
Instrument
connector (3x)
