Leica FL560 User manual

From Eye to Insight
MEDICAL DIVISION
User Manual
10 745 752– Version 03
LeicaFL for M

II LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 1
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.

II LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 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 5
5 Preparation before surgery
(PROVIDO, M530 OHX, M530 OH6, ARveo) 6
5.1 Using the "Fluorescence FL560" user preset 6
5.2 Modifying the FL560 user preset 9
5.3 Get current settings 10
5.4 Creating your own FL560 user 11
5.5 Example "Handle left" assignment 12
5.6 Example "FL" settings 13
5.7 Save user settings 14
6 Preparation before surgery (ARveo 8) 15
6.1 Selecting a profile with FL560 settings 15
6.2 Creating a new surgeon profile 15
6.3 Modifying the FL560 Settings 22
6.4 Activating the FL560 through the GUI 23
7 Operation 24
7.1 Operating Range Limits for FL560 24
7.2 Pre-operation checklist 24
7.3 FL560 test card functional areas 24
7.4 FL560 test card pre-operational check 26
8 Care and maintenance 27
9 What to do, if… 28
9.1 General 28
9.2 Status messages 28
9.3 Electrical 30
9.4 Common troubleshooting steps 31
10 Technical data 32
10.1 LeicaFL560 characteristics 32
10.2 Compatibility 32
10.3 Ambient conditions 32
11 Manufacturer's declaration of
electromagnetic compatibility (EMC) 33

Introduction
2 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 3
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")
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 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 is located on the side
and top of the LeicaFL560 for M530 filter module.
X 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
2 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 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.
X Always follow the instructions in this user manual and in the
user manual of the Leica surgical microscopes, and in particular
the safety notes.
NOTE
Appearance of GUI screenshots
The graphical user interface (GUI) screenshots are for reference only
and can vary in function of the configured options and different
surgical microscopes. However, the functionality of the Leica FL560
is addressed.
3.1 Intended use
The Leica FL560 is a surgical microscope accessory used in viewing
fluorescence of fluorophores with a 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 contraindication 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.
X 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.
X Ensure, that the instrument did not suer any mechanical
interference since it was last used. A pre-operational check
should be carried out prior to each new application.
3.5 Signs and labels
1
2
4
3
The type label is located on the side of the LeicaFL560 for M530
filter module.
1
Leica FL560 for M530MODEL
Leica Microsystems (Schweiz) AG
CH-9435 Heerbrugg
Type label
Federal Law restricts
this device to sale by or
on the order of a
licensed medical
practitioner. (USA Only)
CE label
2UDI Label



Production Identifier (PI)
Serial number
Date of manufacturing
GS1 Data Matrix Code
Device Identifier (DI)
3
REF
SN
a
b
Fabrication label
a Reference number
b Serial number
4 Mandatory label - read
the user manual
carefully before
operating the product.
Web address for
electronic version of the
user manual.
Medical device

Description
4 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 5
4 Description
4.1 Function
The illumination of the Leica M530 surgical microscope 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 M530 optics carrier
2 Leica ULT module
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
The following is an example of a Leica surgical microscope.
2
3
45
3
2
1
1
1
6
2
3
1 Leica M530 optics carrier
2 Camera control unit (optional)
3 Documentation system control unit (optional)
4 Leica M530 OH6, ARveo, ARveo 8 surgical microscopes
5 Leica M530 OHX surgical microscope
6 PROVIDO surgical microscope

Description
4 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 5
4.3 Controls
4.3.1 Status LEDs
1
Leica OH6, ARveo & ARveo 8
PROVIDO
Leica OHX
1
The following LEDs on the swing arm are significant for the
LeicaFL560 for M530 application:
1 Status LED for fluorescence
• LED lights up in cyan = Leica FL560 mode
• LED lights up in white = White light mode (PROVIDO and
M530 OHX only. On M530 OH6, ARveo and ARveo 8 the LED
is simply off in white light mode)
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 Release preselected brakes
You can assign switches 1, 2, 3 and 5(1) 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.
(1)ARveo 8: only the switches 2 and 5 may be individually
assigned.
Handle presets for Fluorescence FL560
PROVIDO M530 OHX / M530 OH6 / ARveo
no function
no function
FL560
mode
on/o no
function
ARveo 8
no function lamp+
no function lamp–
FL560
mode
on/o record
video
no
function
take
picture
All microscopes
Selected brakesSelected brakes
Working
distance
Magni-
fiation
Magni-
fiation

Preparation before surgery (PROVIDO, M530 OHX, M530 OH6, ARveo)
6 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 7
5 Preparation before surgery
(PROVIDO, M530 OHX, M530 OH6, ARveo)
5.1 Using the "Fluorescence FL560" user preset
The current settings for the active user are displayed on the main page:
PROVIDO M530 OHX / M530 OH6 / ARveo
1
X Tap the "Presets" button (1).
The available presets for the microscope are displayed:
2
X Select the "Fluorescence FL560" user preset button (2).
3
X Tap on the "User List" button (3).
The available user list for the microscope is displayed:
4
X Tap the "Presets" button (4).
The available presets for the microscope are displayed:
5
X Select the "Fluorescence FL560" user preset button (5).

Preparation before surgery (PROVIDO, M530 OHX, M530 OH6, ARveo)
6 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 7
NOTE
The FL560 user presets are only available if the FL560 accessory is
enabled in the accessory list of your Leica Surgical Microscope. If
not, please get in contact with your local Leica Service.
After you have selected the "Fluorescence FL560” preset you will be
asked to confirm the change of the user preset.
1
X Select the "Confirm" button (1).
The main page for "Fluorescence FL560" with the actual
settings in white light mode is displayed:
White light mode (PROVIDO) White light mode (M530 OHX / M530 OH6 / ARveo)

Preparation before surgery (PROVIDO, M530 OHX, M530 OH6, ARveo)
8 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 LeicaFL560 for M530 / Ref. 10 745 752 / Version 03 9
Switch the Fluorescence FL560 mode "ON” by using the predefined "ON/OFF button (1) on the left handle.
no function
no function
FL560
mode
on/o no
function
Left Handle
1
X Press the joystick to the left:
The main page for "Fluorescence FL560” with the actual settings in Fluorescence FL560 mode are displayed:
FL560 Mode (PROVIDO) FL560 Mode (M530 OHX / M530 OH6 / ARveo)