Leica FL800 ULT Manual de usuario

MEDICAL DIVISION

User Manual

10 744 763 - Version 06

Leica FL ULT

II Leica FL800 ULT / Ref. 10 744 763 / Version 06

Thank you for purchasing a Leica surgical microscope system.

In developing our systems, we have placed great emphasis on simple, self-

explanatory operation. Nevertheless, we suggest studying this user manual in

detail in order to utilize all the benefits of your new surgical microscope.

For valuable information about Leica Microsystems products and services, and the

address of your nearest Leica representative, please visit our website:

www.leica-microsystems.com

Thank you for choosing our products. We hope that you will enjoy the quality and

performance of your Leica Microsystems surgical microscope.

Leica Microsystems (Schweiz)AG Medical Division

Max-Schmidheiny-Strasse 201 CH-9435 Heerbrugg

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

equipment. Medical decision remains the responsibility of the clinician.

Leica Microsystems has made every effort to provide a complete and clear user

manual highlighting the key areas of product use. Should additional information

regarding the use of the product be required, please contact your local Leica

representative.

You should never use a medical product of Leica Microsystems without the full

understanding of the use and the performance of the product.

Liability

For our liability, please see our standard sales terms and conditions. Nothing in this

disclaimer will limit any of our liabilities in any way that is not permitted under

applicable law, or exclude any of our liabilities that may not be excluded under

applicable law.

Leica FL800 ULT / Ref. 10 744 763 / Version 06 1

Contents

1 Introduction 2

1.1 About this user manual 2

1.2 Symbols in this user manual 2

1.3 Optional product feactures 2

2 Safety notes 3

2.1 Intended use 3

2.2 Dangers of use 3

2.3 Information for the person responsible for the

instrument 3

2.4 Signs and labels 3

3 Description 4

3.1 Function 4

3.2 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 Leica FL800 ULT 11

5.2 Controlling the LeicaFL800 functions 11

6 Care and maintenance 12

7 What to do if...? 12

7.1 General 12

7.2 Leica FL800 ULT 12

8 Technical data 13

8.1 Technical data Leica FL800 ULT 13

8.2 Compatibility 13

8.3 Ambient conditions 13

8.4 Standards fulfilled 13

9 Manufacturer's declaration of electromagnetic

compatibility (EMC) 14

Introduction

2 Leica FL800 ULT / Ref. 10 744 763 / Version 06

1 Introduction

1.1 About this user manual

The Leica FL800 ULT is an accessory for Leica surgical microscopes.

In this user manual the functions of the Leica FL800 ULT are

described.

For information and description of the Leica surgical microscope,

please refer to the user manual of the particular surgical

microscope.

In addition to notes on the use of the instruments

this user manual gives important safety information

(see chapter "Safety notes")

X

Read this user manual carefully before operating the

product.

1.2 Symbols in this user manual

The symbols used in this user manual have the following meaning:

Symbol Warning

word

Meaning

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.

X

Action required; this symbol indicates that

you need to perform a specific action or

series of actions.

1.3 Optional product feactures

Different product features and accessories are optionally available.

The availability varies from country to country and is subject to

local regulatory requirements. Please contact your local

representative for availability.

The subsequent screenshots are reference only and not

representative for all models. however the functionality of the

Leica FL800 ULT is adressed.

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

uorescence 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

Description

4 Leica FL800 ULT / Ref. 10 744 763 / Version 06

3 Description

3.1 Function

The illumination of the Leica FL800 ULT is a xenon lamp and is

located in the Leica surgical microscope. This lamp provides visible

light and the Leica FL800 spectrum. This image cannot be observed

through the surgical microscope, but it is recorded using a special

camera and visualized on the monitor.

Using the handles or via user settings you can switch between

visible and Leica FL800 light.

3.2 Design

The Leica FL800 ULT is an accessory to a Leica surgical microscope.

3.2.1 Optics carrier and Leica FL800 ULT

1 Leica Optics carrier

2 Leica FL800 ULT

• Leica FL800 ULT system components built into the common

housing of the ULT

• Optics carrier with integrated camera for visible light

Leica HD C100 (optional)

• Interface for assistants, either to the left or right side or to

the back

• Main surgeon and back assistant interface, 360° rotatable both

• Back assistant interface with fine focus knob

3.2.2 Stand

The following is an example of a Leica surgical microscope.

1 Leica M530 Optics Carrier

1 Camera control unit (optional)

2 Documentation system control unit (optional)

3 Leica M530 OH6 and ARveo surgical microscope

4 Leica M530 OHX surgical microscope

5 PROVIDO Stand

Description

Leica FL800 ULT / Ref. 10 744 763 / Version 06 5

3.3 Controls

3.3.1 Status LEDs (optional)

Status-LEDs are not available on all Leica surgical

microscopes.

If provided, on the swing arm the following LEDs are significant for

the Leica FL800 ULT application:

1 Status LED for fluorescence

- LED lights up in yellow = Leica FL800 mode

- LED lights up in green = Leica FL800 playback mode

2 Status LED for recording

LED lights up red = recording in progress

3.3.2 Handles

Assignment in the factory setting

1 Magnification

2 4-function joystick

3 Working distance

4 Release all brakes

5 Release preselected brakes

You can assign switches 1, 2, 3 and 5 of the handles

individually for each user in the configuration menu.

In all presets, key (4) releases all brakes. This key cannot be

configured. For the joystick and the other keys presets are

available according to your task.

Handle presets for Leica FL800

Step Loop

FL800

On/O

Play-

back

Y+

Y–

X– X+

3.3.3 Recording system unit (optional)

Please refer to the usermanual of the corresponding

recording system unit.

Preparation before surgery

6 Leica FL800 ULT / Ref. 10 744 763 / Version 06

4 Preparation before surgery

4.1 Adjustments

Adjustments on the Leica Surgical Microscope

control unit for Leica FL800 ULT

Ensure that the Leica FL800 ULT accessories are enabled in

the accessory list in the service menu of your Leica surgical

microscope.

Afterwards, the respective current mode is displayed 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.

The available presets are displayed.

X

Select the "Fluorescence Vascular FL800" user preset.

X

Click on the "Select" button.

The selected user preset is displayed in the top line.

Handle assignment

X

Click on the "Show Settings" button.

X

Select the "Handle Left" or "Handle Right" tab.

You see an overview with which buttons of the left handle

the Leica FL800 functions can be operated.

Preparation before surgery

Leica FL800 ULT / Ref. 10 744 763 / Version 06 7

Modifying the "Fluorescence Vascular FL800" user preset

If you adjusted the settings of the "Fluorescence Vascular

FL800" user preset to your needs during the application, you

can adopt and save them under a new user name.

X

In the "User settings" menu click on "Save" and then on

"Saveas".

X

Select an empty position in the user list.

X

Enter the desired user name via the keyboard.

X

Click on the "Save" button to save your settings under the user

name entered at the desired location.

These settings can later be edited at any time via the User

Settings menu.

Creating your own FL800 user

X

Click on the "Menu" quick access button 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 by Press the "left symbol" or " right symbol", where

symbols are actual GUI TIF used.

X

Assign the function "FL800 Mode On/Off" to any button by

selecting the desired function.

X

Afterwards, click on the label field of the desired button to

assign the desired function.

X

Click on "Save".

X

Select an empty position in the user list.

X

Enter the desired user name via the keyboard, e.g. "icG User".

X

Click on the "Save" button to save your settings under the user

name entered at the desired location.

In the service menu, you can adjust a value fo the maximum

duration of the Leica FL800 mode from 10 to 180seconds.

Brightness

X

Open the "FL" tab to set the brightness in FL800 mode to an

adequate level.

Preparation before surgery

8 Leica FL800 ULT / Ref. 10 744 763 / Version 06

Video Fine Focus

The Leica FL800 ULT offers fine focusing and parfocality reset of the

video focus.

123

The video focus can be adapted to your needs by pressing the focus

button up (3) or/and down (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 parfocality position by

pressing the parfocality button (2). The video focal plane will then

be aligned for all observers with zero diopters respectively with

correct individual diopter settings. This command can be as well

given on the GUI and from the handle, if defined.

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