Leica FL400 User manual

From Eye to Insight
MEDICAL DIVISION
User Manual
10 744 764– Version 04
LeicaFL for M

II Leica FL400 for M530 / Ref. 10 744 764 / Version 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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]
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 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 Purpose 3
3.2 Indication for use 3
3.3 Intended User 3
3.4 Intended Target Population 3
3.5 Dangers of use 3
3.6 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 10
5.7 Save user settings 10
6 Preparation before surgery (ARveo 8) 12
6.1 Creating a surgeon profile 12
6.2 Select an existing surgeon profile 13
6.3 How to use preset profiles 14
6.4 Configuring the user inputs on the handles and foot
switches 15
7 Modifying the FL400 settings (ARveo 8) 19
7.1 Excitation intensity 19
7.2 Fluorescence visibility 20
8 Operation 21
8.1 Operating Range Limits for FL400 21
8.2 Preoperative checklist 21
8.3 Using the Leica FL400 for M530 22
9 Care and maintenance 23
10 What to do, if… 24
10.1 General 24
10.2 Status messages 24
10.3 Electrical 26
10.4 Common troubleshooting steps 27
11 Technical data 28
11.1 Leica FL400 characteristics 28
11.2 Compatibility 28
11.3 Ambient conditions 28
12 Manufacturer's declaration of electromagnetic
compatibility (EMC) 29

Introduction
2 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 Purpose
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.
WARNING
Leica FL400 should only be used with fluorophores
approved for use within the specified spectral ranges.
WARNING
Leica FL400 is not a standalone diagnostic device.
3.2 Indication for use
The indication is dependent on the use of the fluorescence of the
fluorophores used together with the filter.
3.3 Intended User
Leica FL400 is intended for professional use only. The user must
have corresponding technical qualification and have been trained in
the use of the instrument.
3.4 Intended Target Population
The intended target population are patients undergoing a surgical
procedure as defined within the intended purpose and indications
for use.
Contraindication
The medical contraindications applicable to the use of Leica surgical
microscope accessories with Leica FL400 for M530 in combination
with a fluorescence medium are those to be taken into account
when using suitable brand substances.
3.5 Dangers of use
NOTE
Mechanical interference.
X Ensure, that the instrument did not suffer any mechanical
interference since it was last used. A pre-operational check
should be carried out prior to each new application.
3.6 Signs and labels
1
24
3
The type label is located on the side of the Leica FL400 for M530
filter module.
1Typ 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
Leica FL400 for M530MODEL
Leica Microsystems (Schweiz) AG
CH-9435 Heerbrugg

Description
4 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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/ surgeon profile.
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 (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 are examples of Leica surgical microscopes.
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 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 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
Magni-
cation
Magni-
cation

Preparation before surgery (M530 OHX, M530 OH6, ARveo)
6 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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 magnification 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. (see chapter
5.7 "Save user settings")
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 04 Leica FL400 for M530 / Ref. 10 744 764 / Version 04 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
(see chapter 5.1 "Using the "Fluorescence FL400" user preset").
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.