Leica FL560 User manual

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: [phone]
Fax: [phone]
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
2
32
1
1
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
1
Leica OH6 Leica OHX
2
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
1
2
34
2
1

Description
LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 5
4.3.2 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 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
e
on/o
X–
no
function
X+
Selected brakesSelected brakes
Working
distance
Magni-
catio
n
Magni-
cation
Leica FL560 mode on/off
6

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.

Preparation before surgery
LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 9
5.3 Adjustments on the Leica OHX
control unit
5.3.1 Using the " "Fluorescence FL560" " user preset
Main menu currend settings are displayed
 In the Main menu click on the "Preset" button.
The available presets are displayed.
The FL560 user presets are only available if the FL560
accessories are enabled in the accessory list of your Leica
Surgical Microscope. If not, ask the Leica Service to do so.
 Select the "Fluorescence FL560" user preset.
The selected user preset is displayed in the top line.
Main menu Fluorecence FL560/With light setting are displayed
After switching on the FL560 mode the main menu Fluorescence
FL560 settings are displayed.
• As default, the working distance is limited in White light
mode. If desired you can switch off the limitation in the
User settings menu.
• In FL560 mode limitation of working distance and
magnification is always active.

Preparation before surgery
10 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01
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.
 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".

Preparation before surgery
LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 11
 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.
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.
5.4 Pre-operation checklist
Cleaning optical accessories
 Check optical accessories for cleanliness.
Balancing
 Balance the microscope in accordance with adding or removing
components (see the user manual of the particular surgical
microscope).
Operational check
 Switch on the microscope.
 Switch on the illumination.
 Select an FL560 user.
 Check visually whether the microscope illumination has
switched from white to cyan light.
Sterility
 Attach the sterile drape and protection glass.

Operation
12 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01
6 Operation
6.1 Using the LeicaFL560 for M530
 Switch on the illumination of the particular surgical microscope.
 Select either the "Fluorescence FL560" preset user or your own
FL560 user.
The status LED on the swing arm of the particular surgical
microscope is illuminated in cyan if the FL560 mode is active,
and white if switched back to white-light mode.
If the illumination fails in the white-light or FL560 mode,
change to the second illumination source of the illumination
unit.
6.2 Controlling the FL560 functions
no function Y+
no function Y–
FL560
mode
on/o
X–
no
function
X+
 If the FL560 standard settings have been deleted, you can
switch between white-light and FL560 mode by pressing the
joystick of the left Leica M530 handle outward. If another
control has been selected, FL560 mode/white light is activated
accordingly.
7 Care and maintenance
For care and maintenance of the LeicaFL560 for M530,
please refer to the user manual of the particular surgical
microscope.

What to do, if…
LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 13
8 What to do, if…
If electrically operated functions do not work properly,
always check these points first:
• Is the power switch switched on?
• Are the power cables attached correctly?
• Are all connecting cables attached correctly?
• Are all video cables attached correctly?
8.1 General
For malfunctions regarding the Leica stand and the Leica
M530 optics carrier refer to the user manual of the particular
surgical microscope.
8.2 Leica FL560 for M530
Malfunction Cause Remedy
No blue light in
FL560 mode
FL560 mode
is not active
 Check that the fluorescence LED and
the control unit display the FL560
mode.
 Check whether the FL560 ON/OFF
function is assigned to a button of
the handle.
9 Technical data
LeicaFL560 characteristics
Fluorescence excitation 460–500nm ±5% (blue)
Fluorescence observation ≥ 510nm
Camera image size with respect to the field of view
Integrated camera
for visible light
Camera image size
Field of view
Field of view
The figure shows the camera image size with respect to the
field of view for the visual video camera. Please be aware
that the field of view is not fully covered by the
documentation system.
9.1 Compatibility
Leica surgical microscopes Leica M530 OH6
Leica M530 OHX
9.2 Ambient conditions
In use +10 °C to +40 °C
+50 °F to +104 °F
30 % to 95 % rel. humidity
800 mbar to 1060 mbar atmospheric pressure
Storage –30 °C to +70 °C
–86 °F to +158 °F
10% to 100 % rel. humidity
500 mbar to 1060 mbar atmospheric pressure
Transport –30 °C to +70 °C
–86 °F to +158 °F
10% to 100 % rel. humidity
500 mbar to 1060 mbar atmospheric pressure

Manufacturer's declaration of electromagnetic compatibility (EMC)
14 LeicaFL560 for M530 / Ref. 10 745 752 / Version 01
10 Manufacturer's declaration
of electromagnetic
compatibility (EMC)
For the EMC declaration of the Leica FL560 for M530, please
refer to the user manual of the particular surgical
microscope.

LeicaFL560 for M530 / Ref. 10 745 752 / Version 01 15
page left blank intentionally

The fruitful collaboration ”with the user, for the user“ has always been the
foundation of Leica Microsystems‘ innovative strength. On this basis, we
have developed our five corporate values: Pioneering, High-end Quality,
Team Spirit, Dedication to Science, and Continuous Improvement.
MEDICAL DIVISION
What does a surgeon expect from an outstanding surgical microscope?
Sharp, clear images, and a modular system aligned with the surgeon and
OR staff needs.
Innovations for your practice
From the first surgical microscope with widefield optics in the 1980s to the
first microscopes with Horizontal Optics and with LED illumination, Leica
Microsystems has been at the forefront of innovation in the development of
surgical microscopes.
HD video, fluorescence and retinal viewing systems also demonstrate the
continued innovative nature of the Leica team. We strive to provide the
surgeon with leading edge technology to enhance performance, surgeon
comfort, and patient outcomes.
Leica Microsystems – an international company with a strong network of
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Letzte_SOM_UM-IM_en_Revisionsstand_26-06-2014.indd 2 04.12.14 18:01
10 745 752en/01 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2014 • Printed – I.2015 – Editing for printout by galledia • Subject to modifications. • LEICA and the Leica Logo are registered trademarks
of Leica Microsystems IR GmbH.