Leica FL400 User manual

MEDICAL DIVISION
User Manual
10 744 764 - Version 02
LeicaFL for M

II LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
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: [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FL400 for M530 / Ref. 10 744 764 / Version 02 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 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 6
5.3 Pre-operation checklist 11
6 Operation 12
6.1 Using the Leica FL400 for M530 12
6.2 Controlling the FL400 functions 12
7 Care and maintenance 12
8 What to do, if… 13
8.1 General 13
8.2 Leica FL400 for M530 13
9 Technical data 14
9.1 Technical data LeicaFL400 for M530 14
9.2 Compatibility 14
9.3 Ambient conditions 14
10 Manufacturer's declaration of electromagnetic
compatibility (EMC) 15

Introduction
2 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
1 Introduction
1.1 About this user manual
The LeicaFL400 for M530 is an accessory for Leica surgical
microscope systems.
In this user manual the functions of the LeicaFL400 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.
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 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.
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FL400 for M530 / Ref. 10 744 764 / Version 02 3
3 Safety notes
A Leica surgical microscope with LeicaFL400 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 microscope, and in particular
the safety notes.
3.1 Intended use
The LeicaFL400 for M530 serves as a fluorescence excitation light
system in conjunction with an approved tumor-selective substance
(Gliolan = 5-ALA = aminolaevulinic acid) for tissue characterization
in open neurosurgery.
3.2 Contraindications
The medical contraindications applicable to the use of the
LeicaFL400 for M530 in combination with a fluorescence medium
are those to be taken into account when using suitable brand
substances.
WARNING
Danger of injury to the eyes.
 Do not use the LeicaFL400 for M530 in ophthalmology.
3.3 Personnel
Only trained personnel may operate the LeicaFL400 for M530.
3.4 Dangers of use
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.
3.5 Signs and labels
Type label
The type label is located on the side of the LeicaFL400 for M530
filter module.

Description
4 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
4 Description
4.1 Function
The illumination of the surgical microscope systems is a xenon lamp
and is located in the stand.
The Leica FL400 illumination filter module can provide visible and
fluorescence excitation light.
To switch between visible (white) and fluorescence mode
illumination, a handle and/or footswitch button has to be defined
in the user settings for each Leica FL400 user.
4.2 Design
LeicaFL400 for M530 is an accessory for the Leica M530 surgical
microscope.
4.2.1 Optics carrier with LeicaFL400 for M530
2
2
3
11
1 Leica Optics Carrier
2 Leica FL800 ULT
3 Leica FL400 for M530/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FL400 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.
1
2
34
2
1
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
Status-LEDs are not available on all Leica surgical
microscopes.
1
Leica OH6 Leica OHX
2
On the swing arm the following LEDs are significant for the FL400
application:
1 Status LED for fluorescence
- LED lights up in blue = FL400 mode
- LED lights up in yellow = FL800 mode
- LED lights up in green = FL800 playback mode
2 Status LED for recording
LED lights up red = recording in progress

Description
LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 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 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 "Fluorescence oncology FL400"
no function Y+
no function Y–
FL400
mod
e
on/o
X–
no
function
X+
Selected brakesFL400 mode on/off
Working
distance
Magni-
fication
Magni-
fication
Handle presets for "Fluorescence oncology FL400 & IGS DI C500"
IGS
3Y
+
IGS
1Y
–
IGS
4X
–IGS
2X
+
Selected brakesFL400 mode on/off
Working
distance
Magni-
fication
Magni-
fication
Handle presets for "Fluorescence oncology FL400 & Vascular FL800"
FL800 NIR Zoom Reset Y+
Docu FL: Menu&DownY–
FL800
mod
e
on/o
X–
Docu FL:
Playback&
EnterX+
Selected brakesFL400 mode on/off
Working
distance
Magni-
fication
Magni-
fication

Preparation before surgery
6 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
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
5.2.1 Adjustments on the control unit OH6 for
Leica FL400 functions
Using the "Fluorescence Oncology FL400" user preset
The FL400 user presets are only available if the FL400
accessories are enabled in the accessory list in the service
menu of your Leica M530 OH6. If not, ask the Leica service
to do so.
After selecting the user, 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.
 In the Main menu click on the "Preset" button.
The available presets are displayed.
 Select the "Fluorescence Oncology FL400" user preset.
 Click on the "Select" button.
The selected user preset is displayed in the top line.
Either "White Light" or "FL400 Blue Light" is displayed on the
right side.

Preparation before surgery
LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 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 FL400 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 FL400 functions can be operated.
Modifying the "Fluorescence Oncology FL400" user preset
If you adjusted the settings of the "Fluorescence Oncology
FL400" 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 FL400 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 FL400
functions to the handle.
 In the left selection field, select the "Fluorescence" function
group by clicking on it.
 Assign the function "FL400 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.

Preparation before surgery
8 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
 Repeat this process for the other FL400 functions.
 Click "Save".
 Select an empty position in the user list.
 Enter the desired user name via the keyboard, e.g. "5-Ala User".
 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 FL400 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 FL400 mode, the working distance will
be reduced and the picture will get out of focus.

Preparation before surgery
LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 9
5.2.2 Adjustments on the Leica OHX control unit
for Leica FL400 functions
Using the "Fluorescence Oncology FL400" user preset
The FL400 user presets are only available if the FL400
accessories are enabled in the accessory list in the service
menu of your Leica M530 OHX. If not, ask the Leica service
to do so.
After selecting the user, 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.
 In the Main menu click on the "Preset" button.
The available presets are displayed.
Select the "Fluorescence Oncology FL400" user preset.
 Click on the "Select" button.
The selected user preset is displayed in the top line.
Either "White Light" or "FL400 Blue Light" is displayed on the
right side.
• 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 5.3.3.
• In FL400 mode limitation of working distance and
magnification is always active.

Preparation before surgery
10 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
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 FL400 functions can be operated.
Modifying the "Fluorescence Oncology FL400" user preset
If you adjusted the settings of the "Fluorescence Oncology
FL400" 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 FL400 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 FL400
functions to the handle.
 In the left selection field, select the "Fluorescence" function
group by clicking on it.
 Assign the function "FL400 Mode On/Off" to any button by
selecting the desired function.

Preparation before surgery
LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 11
 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 FL400 functions.
 Click "Save".
 Select an empty position in the user list.
 Enter the desired user name via the keyboard, e.g. "5-Ala User".
 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 FL400 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 FL400 mode, the working distance will
be reduced and the picture will get out of focus.
5.3 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 FL400 user.
 Check visually whether the microscope illumination has
switched from white to blue light.
Sterility
 Attach the sterile drape and protection glass.

12 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
6 Operation
6.1 Using the Leica FL400 for M530
 Switch on the illumination of the particular surgical microscope.
 Select either the "Fluorescence Oncology FL400" preset user or
your own FL400 user.
The status LED on the swing arm of the particular surgical
microscope is illuminated in blue if the FL400 mode is active,
and white if switched back to white-light mode.
If the illumination fails in the white-light or FL400 mode,
change to the second illumination source of the illumination
unit.
6.2 Controlling the FL400 functions
no function Y+
no function Y–
FL400
mode
on/o
X–
no
function
X+
 If the FL400 standard settings have been deleted, you can
switch between white-light and FL400 mode by pressing the
joystick of the left Leica M530 handle outward. If another
control has been selected, FL400 mode/white light is activated
accordingly.
7 Care and maintenance
For care and maintenance of the LeicaFL400 for M530,
please refer to the user manual of the particular surgical
microscope.

LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 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 FL400 for M530
Malfunction Cause Remedy
No blue light in
FL400 mode
FL400 mode
not active
 Check that the fluorescence LED and
the control unit display the FL400
mode.
 Check whether the FL400 ON/OFF
function is assigned to a button of
the handle.

Technical data
14 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02
9 Technical data
9.1 Technical data LeicaFL400 for
M530
FL400 characteristics
Fluorescence excitation 405 nm (blue light)
Fluorescence signal 635 nm (red)
FL400 spectrums
Leica M530 with built-in module LeicaFL400 for M530
Image sensor 1/2.8" CMOS
Integrated camera for
visible light
Leica HD C100 built in (optional)
For other technical data refer to the user manual of the
particular surgical microscope system.
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.
9.2 Compatibility
Leica surgical microscopes Leica M530 OH6
Leica M530 OHX
9.3 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)
LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 15
10 Manufacturer's declaration of electromagnetic compatibility
(EMC)
For the EMC declaration of the LeicaFL400 for M530, please refer to the user manual of the particular Leica surgical microscope
system.

16 LeicaFL400 for M530 / Ref. 10 744 764 / Version 02

LeicaFL400 for M530 / Ref. 10 744 764 / Version 02 17

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.
The Medical Division, within Leica Microsystems (Schweiz) AG,
holds the management system certificates for the international
standards ISO 9001, ISO 13485, and ISO 14001 relating to quality
management, quality assurance and environmental management.
Leica Microsystems – an international company with a strong network of
worldwide customer services:
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10 744 764en/02 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2014 • Printed – X.2014 – Editing for printout by galledia •
Subject to modifications. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH.