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2
Safety notes
A Leica surgical microscope with GLOW800 is state-of-the-art
technology. Nevertheless, hazards can arise during operation.
Always follow the instructions in this user manual and in the
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X
user manual of the Leica surgical microscope, and in particular
the safety notes.
Federal Law restricts this device to sale by or on the order of a
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X
licensed medical practitioner.
2.1
Intended use
• The GLOW800 is a Leica surgical microscope accessory used in
viewing intra-operative blood flow in the cerebral vascular area
and bypass grafts during coronary artery bypass (CABG)
surgery, as well as blood flow during plastic and reconstructive
surgery.
Contraindication
• The medical contraindications applicable to the use of the
Leica surgical microscope with GLOW800 in combination with a
fluorescence medium are those to be taken into account when
using suitable brand substances and state-of-the-art
examination techniques.
WARNING
Danger of injury to the eyes.
Do not use GLOW800 in ophthalmology.
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X
2.2
Dangers of use
WARNING
Risk of infection due to insterile MFL800 test card.
Do not use the MFL800 test card in the sterile field.
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X
Use only in non-sterile environment.
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X
WARNING
User selected with a programmed fluorescence function.
Correct user is activated.
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X
Preperational check is performed.
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X
Microscope illumination lamp is within tolerances (see
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X
user manual of the Leica surgical microscope).
WARNING
Risk of infection due to insterile MFL800 test card.
Check the microscope illumination in non-sterile
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X
environment only.
2.3
When using GLOW800 please ensure to have a Doppler
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X
Ultrasound or similar in place, in case of none or insufficient
blood flow visualization out of the ICG/GLOW800 procedure is
given.
2.4
Type label
GLOW800 / Ref. 10 747 241 / Version 00
WARNING
Danger of injury to the patient due to not approved
fluorescence media.
Only use fluorescence media approved for the planned
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X
application.
WARNING
Danger of injury to the patient due to excessive GLOW800
radiation.
Avoid extended and/or excessively frequent use of
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X
GLOW800 radiation.
GLOW800 mode is disabled automatically no later than
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X
after 180 seconds to prevent excessive exposure of the
patient to GLOW800 radiation.
Information for the person
responsible for the instrument
Signs and labels
Safety notes
3
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