Leica FL400 User manual

From Eye to Insight
MEDICAL DIVISION
User Manual
10 744 764 – Version 03
LeicaFL for M

II LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / 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FL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / 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 4
5 Preparation before surgery
(M530 OHX, M530 OH6, ARveo) 6
5.1 Using the "Fluorescence FL400" user preset 6
5.2 Modifying the FL400 user preset 7
5.3 Get current settings 8
5.4 Creating your own FL400 user 8
5.5 Example "Handle left" assignment 9
5.6 Example "FL" settings 9
5.7 Save user settings 10
6 Preparation before surgery (ARveo 8) 12
6.1 Selecting a profile with FL400 settings 12
6.2 Creating a new surgeon profile 12
6.3 Modifying the FL400 Settings 19
6.4 Activating the FL400 through the GUI 20
7 Operation 21
7.1 Operating Range Limits for FL400 21
7.2 Pre-operation checklist 21
7.3 Using the LeicaFL400 for M530 21
8 Care and maintenance 22
9 What to do, if… 23
9.1 General 23
9.2 Status messages 23
9.3 Electrical 25
9.4 Common troubleshooting steps 26
10 Technical data 27
10.1 LeicaFL400 characteristics 27
10.2 Compatibility 27
10.3 Ambient conditions 27
11 Manufacturer's declaration of
electromagnetic compatibility (EMC) 27

Introduction
2 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 3
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")
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FL400 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FL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 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.
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 FL400
is addressed.
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 = 5-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.
X 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.
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FL400 for M530
filter module.
1
Leica FL400 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FL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / 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 FL400 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 FL400 user.
4.2 Design
The LeicaFL400 for M530 is an accessory for the Leica M530 surgical
microscope.
4.2.1 Optics carrier with LeicaFL400 for M530
2
32
1
1
1 Leica M530 optics carrier
2 Leica ULT module
3 LeicaFL400 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.
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
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FL400 for M530 application:
1 Status LED for fluorescence
• LED lights up in blue = Leica FL400 mode
• LED lights up in white = White light mode (M530 OHX only.
On M530 OH6, ARveo and ARveo 8 the LED is simply off in
white light mode)

Description
4 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 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(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 FL400
M530 OHX / M530 OH6 / ARveo
no function Y+
no function Y–
FL400 X–
no
function
X+
ARveo 8
no function lamp+
no function lamp–
FL400
record
video
no
function
take
picture
All microscopes
Selected brakesSelected brakes
Working
distance
Magnifi-
cation
Magnifi-
cation

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
6 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 7
5 Preparation before surgery
(M530 OHX, M530 OH6,
ARveo)
5.1 Using the "Fluorescence FL400"
user preset
The current settings for the active user are displayed on the main
page:
1
X Tap on the "User List" button (1).
The available user list for the microscope is displayed:
2
X Tap the "Presets" button (2).
The available presets for the microscope are displayed:
3
X Select the "Fluorescence FL400" user preset button (3).
NOTE
The FL400 user presets are only available if the FL400 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 FL400" preset you will be
asked to confirm the change of the user preset.
4
X Select the "Confirm" button (4).
The main page for "Fluorescence FL400" with the actual
settings in white light mode is displayed:

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
6 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 7
Switch the Fluorescence FL400 mode "ON" by using the predefined
"ON/OFF button (1) on the left handle.
no function
no function
FL400
no
function
Left Handle
1
X Press the joystick to the left:
The main page for "Fluorescence FL400" with the actual
settings in Fluorescence FL400 mode are displayed:
NOTE
In FL400 mode, limitation of working distance and magnication is
always active.
X To switch back to the white light mode press the joystick of the
left handle to the left side once again.
The main menu "Fluorescence FL400" with the actual settings
in white light mode are displayed.
5.2 Modifying the FL400 user preset
The factory FL400 user settings cannot be overwritten,
however if you adjusted the settings to your needs, you can
adopt and save them under a new user name. Please see
chapter 5.7
NOTE
Do not change the settings or edit the user list when the
microscope is in direct use on a patient. The FL400 mode is
automatically stopped when modifying the settings.

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
8 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 9
5.3 Get current settings
On the page "Main > Fluorescence FL400" for both white light and
FL400 modes, a "Show Settings" button can be found.
1
X Tap the "Show Settings" button (1).
The "User Settings > Fluorescence FL400" page is displayed. On
this page you can find several tabs with information on the
current settings of the Leica surgical microscope system.
X Tap the "Handle Left" tab (2).
This shows an overview of the buttons on the "Handle Left"
including the button with which the FL400 functions (ON/OFF)
can be operated:
2
5.4 Creating your own FL400 user
You can create and save your own FL400 settings according to your
preferences.
X Before creating your own FL400 user follow the steps in chapter
5.1.
X Tap the quick access "Menu" button (1) once you are on the
main page for FL400:
1
After pressing the button the following screen is displayed:
2
X Tap the "User Settings" button (2).
In each of the displayed tabs you can change the predefined
user settings.

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
8 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 9
5.5 Example "Handle left" assignment
X Tap the "Handle left" tab (2).
This displays the user settings page for the left handle. On the
handle left assignment screen you can assign up to nine
functions of your choice:
21
Example: Assigning the "Fluorescence FL400" button for activating
and de-activating the FL400 mode.
X In the left selection field (1) scroll to the function group
"Fluorescence" by using the arrowheads (3).
3
X Select the desired "Fluorescence FL400" function you wish to
assign. In this example it would be: "FL400 Mode On/Off".
X Click on a free or assigned caption of the desired button on the
handle to assign the selected function to it.
NOTE
The "All Brakes" function is always assigned to the rear switch (1)
for both handles and can neither be overwritten nor deleted.
The inner switch (2) to which "Selected Brakes" is pre-assigned but
can be freely assigned to your wishes.
1
2
1
5.6 Example "FL" settings
X Tap the "Menu" button in the header.
X Select "User Settings".
X Select the "FL" tab to set the brightness in FL400 mode to an
adequate level.
Recommended and default brightness level is 100%.
X Scroll to the brightness level you like to use by using the
arrowheads.
X Decide if the working distance (WD) limitation in White light
mode should be switched ON (default) or OFF1,2.

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
10 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 11
NOTE
1) Please note that a factory limitation is applied to the working
distance (see 7.1) as soon as the FL400 mode is activated. Hence, if
working distance (WD) limitation in White light mode is switched
o and the working distance is above this limit (see 7.1) when
switching to FL400 mode, the working distance will be reduced and
the picture will get out of focus.
2) This limitation can be activated within the FL400 mode settings
menu [see graphics above]. This setting will enable or disable the
WD limitation during white light mode. While using the WD
limitation, the microscope might need to be repositioned (meeting
the WD limitation value or getting closer than the WD limitation
value) to get into focus.
The WD and Mag limitation values can be redened to higher or
smaller values generally for all users by Leica service personnel in
the service menu to t the needs of the surgical workow.
5.7 Save user settings
After adapting the user settings, you can save your changes under a
new username.
1
X In the "User settings" menu tap on "Save" (1) and then on
"Saveas New" buttons.
A editable list of users is displayed:
X Select an available location in the user list at which you want to
store your settings.

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
10 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 11
X Enter the desired username using the on-screen keyboard.
X Tap the "OK" button to save the user settings at the desired
location under the name you have entered.
NOTE
User setting protection
To avoid unauthorized or accidental changes of user settings, each
user setting can be protected by a password/PIN. This keeps the
working parameters identical each time you load a protected user
setting. Changes can be done during the application but will not
bestored unless saved by pressing "Save" and choosing either
the"Save as current" or "Save as new" option, using the correct
password/PIN or by creating a new user and password/PIN
combination respectively.
Please refer to the user settings chapter in the manual of your
respective surgical microscope for detailed instructions on how to
set or change passwords.

Preparation before surgery (ARveo 8)
12 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 13
6 Preparation before surgery
(ARveo 8)
6.1 Selecting a profile with FL400
settings
X Select a surgeon profile for which the FL400 profile has been
already been defined at the "Select surgeon" page:
If not, you have to create a new surgeon profile.
6.2 Creating a new surgeon profile
6.2.1 Register the new profile details
X Tap the "Create New" button (1) on the "Select surgeon" page:
1
The "Create New Surgeon Profile" page is displayed
X Please fill in at least the mandatory data for a surgeon profile,
i.e. first name and a unique three-letter acronym. Fields marked
with a * are mandatory.
You can enter your last name and a "passcode" to secure
your settings. This is recommended to avoid unintended
changes by other surgeons or personnel. Please note that
the "passcode" has to be typed twice to confirm it.
1 2
You can either press "Copy" (1) or "Create New" (2) .
• The "Copy" function (see section 6.2.2) allows to copy settings
from a preset or an existing surgeon profile which can then be
adapted to your needs.
• The "Create New" function (see section 6.2.3) allows to start
from blank list of user input settings which you can configure.

Preparation before surgery (ARveo 8)
12 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 13
6.2.2 Copying settings from the FL400 Preset or existing surgeon profile
This section describes how you can copy existing settings into your newly created surgeon profile using either an existing surgeon's profile
or using the factory FL400 preset.
X Tap the "Copy" button (1) on the "Create New Surgeon Profile" page.
1
The list of existing profiles and presets is displayed on screen:
1 2
The factory preset profiles are displayed at the top and are
generally prefixed with an underscore (i.e. _Tumor)
You have now two options:
Copy the predefined FL400 preset Copy settings from an existing surgeon profile
X Click on the _Tumor profile (1) and confirm with "OK" (2)
The dialog box is closed and the _Tumor profile is now copied
into the surgeon's profile and allows for activation of the
FL400 mode by pushing the joystick of the left handle towards
the left.
X Press the "Create New" button to register the new surgeon
profile.
X Click on the surgeon profile you want to copy and confirm
with "OK" (2).
The dialog box is closed and the selected surgeon's profile and
function mappings are now copied into the new surgeon
profile you just created.
X Press the "Create New" button to register the new surgeon
profile.

Preparation before surgery (ARveo 8)
14 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 15
In both cases (copying FL400 preset or copying an existing surgeon
profile), after pressing "Create New", the live screen is displayed.
You can see the surgeon profile's name on the top right corner of
the screen (1):
1
X You can now follow the steps described in 6.2.4 to configure the
user input settings.
6.2.3 Creating a brand new profile
To create a new profile, you must first follow the steps described in
6.2.1.
X After having entered the new surgeon data, instead of pressing
"Copy", press the "Create New" button in order to register the
new profile.
This will register the new surgeon profile with a blank list of
settings which are ready for you to configure.
The live screen is displayed on which you can see the surgeon
profile's name on the top right hand corner of the screen (1):
1
X You can now follow the steps described in 6.2.4 to configure the
user input settings.

Preparation before surgery (ARveo 8)
14 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 15
6.2.4 Configuring the user inputs
Make sure you are on the live screen for the selected or newly
created surgeon profile:
1
X Press the menu button (1) on the top left hand corner of the
screen to show the list of options.
The options screen is displayed:
2
X Tap on the "User Inputs" button (2) to open the "User Inputs"
menu.
The "User Inputs" menu is displayed:
3
X Tap "Handles" button (3) to show the "Left Handle" settings.
The Left Handle configuration screen is displayed:
You can now view or edit the handle settings for the selected
surgeon profile.
NOTE
X Click on "Right" if you want to congure the right handle.

Preparation before surgery (ARveo 8)
16 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 17
6.2.5 Example of how to assign the FL400 function
The following example shows how you can assign the FL400
function to a button on the left handle.
NOTE
This process can also be used for any of the buttons to which you
wish to assign any other function.
X When you are on the handle configuration page, click the
button you want to assign for the activation of the FL400 mode.
This will display the "Select function" popup window for the
selected button:
1
X Select the "Fluorescence" tab (1).
A list of available FL functions will be displayed:
23
X Select the FL400 function (2) and tap "Confirm" (3) to store the
settings.
Press "Delete" to go back and "Cancel" if you want to select
another function.
A functional overview of the left handle will be displayed:
4
X Tap the "Back" button (4) once you have finished adapting your
settings.
The "Save Surgeon Settings" window will be displayed:
5 6
X Save and store the settings by pressing "Yes, change in profile"
(6). If you do not wish to store the settings, please press "No,
only use now" (5).
X Move back in the menu hierarchy by pressing "Back"
successively until you return to the "Options" page:
7
X Press "X" (7) to go back to the live screen.

Preparation before surgery (ARveo 8)
16 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 17
The live screen is displayed:

Preparation before surgery (ARveo 8)
18 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 LeicaFL400 for M530 / Ref. 10 744 764 / Version 03 19
6.2.6 Selecting the FL400 Preset
NOTE
The preset can be used to quickly enable the FL400 ON/OFF functionality
on the microscope.
This preset profile can be used and modified but any changes to the
profile settings will not be stored, therefore with each new start up, the
default profile settings will be restored.
Moving the joystick on the left handle to the left activates, resp.
de-activates the FL400 mode.
This preset can also be be used as a starting point when creating a new
surgeon profile (see 6.2.2).
Because the modifications to this preset cannot be saved, it is highly
recommended to create a new surgeon profile for a full workflow.
1
X While on the "Select Surgeon" menu tap the "Show preset
profiles" button (1) to receive a list of preset profiles, dependent
on the installed licenses.
The list of "Preset profiles" is displayed:
2
X Select the _Tumor preset (2).
When choosing this preset profile, a popup will appear to notify the
user about the profile limitations.
It is highly recommended to change an existing or add a new
surgeon profile to integrate the FL400 function in a full workflow.
The following functions are assigned when selecting the FL400
preset:
no function lamp+
no function lamp–
FL400
record
video
no
function
take
picture
You can swtich back to white light mode by pushing the
joystick of the left handle towards the left again.