Safety notes
Leica FL800 ULT / Ref. 10 744 763 / Version 06
3
2 Safety
notes
A Leica surgical microscope with Leica FL800 ULT is state-of-the-art
technology. Nevertheless, hazards can arise during operation.
X
Always follow the instructions in this user manual and in the
user manual of the Leica surgical microscope, and in particular
the safety notes.
2.1 Intended
use
• The Leica FL800 ULT is a surgical microscope accessory used in
viewing intra-operative blood flow in the cerebral vascular
area, blood flow of the coronary vascular 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 Leica FL800 ULT 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.
X
Do not use Leica FL800 ULT in ophthalmology.
2.2 Dangers of use
WARNING
Risk of infection due to insterile Leica FL800 ULT test
patterns.
X
Check the Leica FL800 ULT illumination in non-sterile
environment only.
WARNING
Danger of injury to the patient due to not approved
fluorescence media
X
Only use fluorescence media approved for the planned
application.
WARNING
Danger of injury to the patient due to excessive Leica FL800
radiation
X
Avoid extended and/or excessively frequent use of
Leica FL800 radiation.
X
Leica FL800 mode is disabled automatically no later
than after 180 seconds to prevent excessive exposure of
the patient to Leica FL800 radiation.
2.3 Information for the person
responsible for the instrument
X
When using Leica FL800 ULT please ensure to have a Doppler
Ultrasound or similar in place, in case of none or insufficient
blood flow visualization out of the ICG/Leica FL800 ULT
procedure is given.
2.4 Signs and labels
Type label
