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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

Summary of Contents for FL800 ULT

Page 1: ...MEDICAL DIVISION User Manual 10 744 763 Version 06 Leica FL800 ULT...

Page 2: ...ugg Phone 41 71 726 3333 Fax 41 71 726 3334 Legal disclaimer All specifications are subject to change without notice The information provided by this manual is directly related to the operation of the...

Page 3: ...Design 4 3 3 Controls 5 4 Preparation before surgery 6 4 1 Adjustments 6 4 2 Checking the Leica FL800 ULT illumination 9 4 3 Pre operation checklist Leica FL800 ULT 10 5 Operation 11 5 1 Using the Lei...

Page 4: ...se 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 Indicate...

Page 5: ...g 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...

Page 6: ...Leica surgical microscope 3 2 1 Optics carrier and Leica FL800 ULT 2 2 1 1 1 Leica Optics carrier 2 Leica FL800 ULT Leica FL800 ULT system components built into the common housing of the ULT Optics c...

Page 7: ...rding in progress 3 3 2 Handles 1 2 4 3 5 4 1 2 Assignment in the factory setting 1 Magnification 2 4 function joystick 3 Working distance 4 Release all brakes 5 Release preselected brakes You can ass...

Page 8: ...splayed on the right of the status line of the control unit and indicated by the LEDs on the swing arm Using the Fluorescence Vascular FL800 user preset X In the Main menu click on the Presets button...

Page 9: ...utton and select User Settings X Select New User X Open the Handle Left or Handle Right tab to assign FL800 functions to the handle X In the left selection field select the Fluorescence function group...

Page 10: ...own 1 This command can be given to the GUI and from the handle if defined Focus adjustment operates in both directions with an endless circular movement The video fine focus can be re adjusted to parf...

Page 11: ...care to ensure the precise parfocal setting of the Leica surgical microscope Follow the instructions on parfocal setup X Activate Leica FL800 mode with the handle A connected monitor will display the...

Page 12: ...n case of none or insufficient blood flow visualization out of the ICG Leica FL800 ULT procedure is given Balancing X Balance the microscope after refitting see the user manual of the Leica surgical m...

Page 13: ...NING Danger of injury to the patient due to excessive Leica FL800 radiation X Avoid extended and or excessively frequent use of Leica FL800 radiation Leica FL800 mode is disabled automatically no late...

Page 14: ...Leica FL800 ULT Malfunction Cause Remedy No NIR image displayed FL800 mode is not active X Check that the fluorescence LED and the control unit display the FL800 mode X Check whether the FL800 On Off...

Page 15: ...ectromagnetic compatibility IEC 60601 1 2 EN 60601 1 2 The Medical Division within Leica Microsystems Schweiz AG holds the management system certificates for the international standard ISO 13485 relat...

Page 16: ...a FL800 ULT Ref 10 744 763 Version 06 9 Manufacturer s declaration of electromagnetic compatibility EMC The Leica FL800 ULT was tested in combination with Leica surgical microscopes For the EMC declar...

Page 17: ...Leica FL800 ULT Ref 10 744 763 Version 06 15...

Page 18: ...dical Division CH 9435 Heerbrugg 2019 Printed 10 2019 Subject to modifications LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH CONNECT WITH US HLFD 0LFURV VWHPV 6FKZHL...

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