Leica FL560 Manual de usuario

MEDICAL DIVISION

User Manual

10 745 752 - Version 01

LeicaFL for M

II LeicaFL560 for M530 / Ref. 10 745 752 / Version 01

Thank you for purchasing a Leica surgical microscope accessory.

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FL560 for M530 / Ref. 10 745 752 / Version 01 1

Contents

1 Introduction 2

1.1 About this user manual 2

1.2 Symbols in this user manual 2

1.3 Optional product features 2

2 Product identification 2

3 Safety notes 3

3.1 Intended use 3

3.2 Contraindications 3

3.3 Personnel 3

3.4 Dangers of use 3

3.5 Signs and labels 3

4 Description 4

4.1 Function 4

4.2 Design 4

4.3 Controls 4

5 Preparation before surgery 6

5.1 Calibration check 6

5.2 Adjustments on the Leica OH6 control unit 6

5.3 Adjustments on the Leica OHX control unit 9

5.4 Pre-operation checklist 11

6 Operation 12

6.1 Using the LeicaFL560 for M530 12

6.2 Controlling the FL560 functions 12

7 Care and maintenance 12

8 What to do, if… 13

8.1 General 13

8.2 Leica FL560 for M530 13

9 Technical data 13

9.1 Compatibility 13

9.2 Ambient conditions 13

10 Manufacturer's declaration of electromagnetic

compatibility (EMC) 14

Introduction

2 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01

1 Introduction

1.1 About this user manual

The LeicaFL560 for M530 is an accessory for Leica surgical

microscope systems.

in this user manual the functions of the LeicaFL560 for M530 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")

 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.

 Action required; this symbol indicates that

you need to perform a specific action or

series of actions.

1.3 Optional product features

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.

2 Product identification

The model and serial numbers of your product are located on the

identification label on the illumination unit.

 Enter this data in your user manual and always refer to it when

you contact us or the service workshop regarding any questions

you may have.

Type Serial no.

...

Safety notes

LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 3

3 Safety notes

A Leica surgical microscope with LeicaFL560 for M530 is state-of-

the-art technology. Nevertheless, hazards can arise during

operation.

 Always follow the instructions in this user manual and in the

user manual of the Leica surgical microscopes, and in particular

the safety notes.

3.1 Intended use

The Leica FL560 allows the fluorescence observation of

fluorophores with an excitation peak between ~460nm and

~500nm (blue) and the fluorescence emission observation

comprising the green, yellow and red spectrum in a spectral band

above ~510nm.

3.2 Contraindications

• The medical contraindications applicable to the use of the

Leica FL560 in combination with a fluorescence medium are

those to be taken into account when using suitable brand

substances.

• Medical decision remains the responsibility of the clinician.

WARNING

Danger of injury to the eyes.

 Do not use the LeicaFL560 for M530 in ophthalmology.

3.3 Personnel

Only trained personnel may operate the LeicaFL560 for M530.

3.4 Dangers of use

NOTE

Mechanical interference.

 Ensure, that the instrument did not suer any mechanical

interference since it was last used. A calibration check should be

carried out prior to each new application. These can be provided

by your IGS partner.

3.5 Signs and labels

Type label

LEICA FL560 for M530

The type label is located on the side of the LeicaFL560 for M530

filter module.

Description

4 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01

4 Description

4.1 Function

The illumination of the surgical microscope Leica M530 is a xenon

lamp located in the stand.

The Leica FL560 illumination filter module can provide visible and

fluorescence excitation light.

To switch between visible (white) light and fluorescence mode

illumination, a handle and/or foot paddle button has to be defined

in the user settings for each Leica FL560 user.

4.2 Design

The LeicaFL560 for M530 is an accessory for the LeicaM530 surgical

microscope.

4.2.1 Optics carrier with LeicaFL560 for M530

1 Leica optics carrier

2 Leica FL800 ULT

3 LeicaFL560 for M530

• Optics carrier with integrated camera for visible light

LeicaHDC100 (optional)

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

back

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

• Back assistant interface with fine focus knob

• Fluorescence observation filter module (LeicaFL560 for M530)

• Leica ULT system components built into the common housing of

the ULT

4.2.2 Stand OH6

The following is an example of a Leica surgical microscope.

1 Camera control unit

2 Documentation system control unit

3 Leica M530 OH6 surgical microscope

4 Leica M530 OHX surgical microscope

4.3 Controls

4.3.1 Status LEDs

Leica OH6 Leica OHX

The following LEDs on the swing arm are significant for the

Leica FL560 application:

1 Status LED for fluorescence

- LED lights up in blue = LeicaFL400 mode

- LED lights up in cyan = LeicaFL560 mode

- LED lights up in yellow = LeicaFL800 mode

- LED lights up in green = LeicaFL800 playback mod

2 Status LED for recording

LED lights up red = recording in progress

Description

LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 5

4.3.2 Handles

Assignment in the factory setting

1 Magnification

2 4-function joystick

3 Working distance

4 Release all brakes

5 Leica FL560 mode on/off

6 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 Flurescence FL560

no function Y+

no function Y–

FL560

mod

on/o

X–

function

X+

Selected brakesSelected brakes

Working

distance

Magni-

catio

Magni-

cation

Leica FL560 mode on/off

Preparation before surgery

6 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01

5 Preparation before surgery

5.1 Calibration check

NOTE

Mechanical interference

To ensure that the instrument did not suffer any mechanical

interference since it was last used, a calibration check should be

carried out prior to each new application. These can be provided

byyour IGS partner.

5.2 Adjustments on the Leica OH6

control unit

5.2.1 Using the "Leica FL560" user preset

Main menu currend settings are displayed

 In the Main menu click on the "Presets" button.

The Leica FL560 user presets are only available if the Leica

FL560 accessories are enabled in the accessory list of your

Leica Surgical Microscope. If not, ask the Leica Service to do

so.

The availbale presets are displayed.

 Click on the "Fluorescence FL560" user preset.

The selected user preset is displayed in the top line.

Either "White Light" or "FL560" is displayed on the right side.

Preparation before surgery

LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 7

• As default, the working distance is limited in White light

mode. If desired you can switch off the limitation in the

User settings menu, see section 5.2.3.

• In FL560 mode limitation of working distance and

magnification is always active.

Handle assignment

 Click on the "Show Settings" button.

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

You see an overview with which buttons of the selected handle

the FL560 functions can be operated.

Modifying the "Fluorescence FL560" user preset

If you adjusted the settings of the "Fluorescence FL560" user

preset to your needs during the application, you can adopt

and save them under a new user name.

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

"Saveas".

 Select an empty position in the user list.

 Enter the desired user name via the keyboard.

 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 FL560 user

 Click on the "Menu" quick access button and select

"UserSettings".

 Select "New User".

 Open the "Handle Left" or "Handle Right" tab to assign FL560

functions to the handle.

 In the left selection field, select the "Fluorescence" function

group by clicking on it.

 Assign the function "FL560 Mode On/Off" to any button by

selecting the desired function.

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

assign the desired function.

– or –

Press the desired button on the handle to be assigned.

 Repeat this process for the other FL560 functions.

 Click "Save".

 Select an empty position in the user list.

 Enter the desired user name via the keyboard.

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

name entered at the desired location.

Preparation before surgery

8 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01

Brightness

 Open the "FL" tab to set the brightness in FL560 mode to an

adequate level.

 Decide if the working distance limitation in White light mode

should be switched on (default) or off.

When the working distance limitation in White light mode

is switched off and the working distance is above the limit

when switching to FL560 mode, the working distance will

be reduced and the picture will get out of focus.

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