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Introduction
1
Introduction
1.1
About this user manual
This user manual describes the function of GLOW800 in combination
with ARveo 8 (10449157). For information and description of
ARveo 8 (10449157), refer to the corresponding user manual.
In addition to notes on the use of the instruments,
this user manual gives important safety information
(see chapter 2 "Safety notes", page 4).
Read this user manual carefully before operating the
X
product.
1.2
Symbols in this user manual
The symbols used in this user manual have the following meaning:
Symbol
Warning
Meaning
word
Warning
Indicates a potentially hazardous situation
or improper use that could result in serious
personal injuries or death.
Caution
Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in minor or moderate injury.
Note
Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in appreciable material, financial
and environmental damage
Information about use that helps the user
to employ the product in a technically
correct and efficient way.
Action required; this symbol indicates that
X
you need to perform a specific action or
series of actions.
4
2
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
X
user manual of ARveo 8, and in particular the safety notes.
Federal Law restricts this device to sale by or on the order of a
X
licensed medical practitioner.
2.1
GLOW800 is used in viewing fluorescence of fluorophores with an
excitation peak between ~750 nm and ~800 nm and the resulting
fluorescence emission observation in a spectral band above
~800 nm.
2.2
The GLOW800 is a Leica surgical microscope accessory used in
viewing intra-operative blood flow in the cerebral vascular region
and bypass grafts during coronary artery bypass (CABG) surgery, as
well as blood flow during plastic and reconstructive surgery.
Contraindications
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.
2.3
The intended target population are patients undergoing a
procedure as defined within the intended purpose.
2.4
The GLOW800 is intended for professional use only. The user must
have corresponding technical qualification and have been trained in
the use of the instrument.
GLOW800 / Ref. 10 748 652 / Version 01
Safety notes
Intended purpose
Indications for use
WARNING
Danger of injury to the eyes.
Do not use GLOW800 in ophthalmology.
X
Patient target group
Intended user
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