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2.5
Dangers of use
WARNING
Risk of infection due to unsterile GLOW800 test card
Do not use the GLOW800 test card in the sterile field.
X
Use only in non-sterile environment.
X
Check the microscope illumination in non-sterile
X
environment only.
Take care to ensure the precise parfocal setting of the
X
ARveo 8. Follow the instructions on parfocal setup.
WARNING
Surgeon profile without a programmed fluorescence
function
Select the correct surgeon profile.
X
Perform a pre-operative check.
X
Check if the microscope illumination lamp is within
X
tolerances (see user manual of ARveo 8).
WARNING
Danger of injury to the patient due to not approved
fluorescence media
Only use fluorescence media approved for the planned
X
application, for example Indocyanine Green (ICG).
CAUTION
Danger of injury to the patient due to excessive GLOW800
radiation
GLOW800 mode is disabled automatically after 180 seconds.
However, extended and/or excessively frequent use of
GLOW800 damages the patient's skin and tissue.
Avoid excessive exposure of the patient to GLOW800
X
radiation.
CAUTION
Caution to the user.
Check the perception of the 3D view prior to surgery. If
X
you do not feel confident with the 3D view, switch to 2D
view.
2.6
When using GLOW800 please ensure to have a Doppler
X
Ultrasound or similar in place, in case of none or insufficient
blood flow visualization out of the ICG/GLOW800 procedure is
given.
2.7
Type label
UDI Label
Mandatory label
Read the user manual carefully before operating the product. Web
address for electronic version of the user manual.
GLOW800 / Ref. 10 748 652 / Version 01
Information for the person
responsible for the instrument
Signs and labels
Device Identifier (DI)
GS1 Data Matrix Code
Production Identifier (PI)
Serial number
Date of manufacturing
Safety notes
5
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