Leica GLOW400 User manual

MEDICAL DIVISION
User Manual
10 748 697 - Version 01
GLOW

II GLOW400 / Ref. 10 748 697 / Version 01
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]
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.

GLOW400 / Ref. 10 748 697 / Version 01 1
Contents
1 Introduction 2
1.1 About this user manual 2
1.2 Symbols in this user manual 2
2 Safety notes 2
2.1 Intended use 2
2.2 Indications for use 2
2.3 Intended User 2
2.4 Intended Target Population 2
2.5 Dangers of use 3
2.6 Directions for the person responsible for the
instrument 4
2.7 Signs and labels 4
3 Description 5
3.1 Function 5
3.2 Design 5
4 Controls 6
4.1 Handles 6
4.2 Foot switch 6
4.3 Status LEDs 7
5 Visualization 7
5.1 Overview 7
5.2 2D and 3D view 8
5.3 GLOW400 visualization types 9
5.4 GLOW400 visualization arrangements 10
6 Preparation before surgery 11
6.1 Creating a surgeon profile 11
6.2 Select an existing surgeon profile 12
6.3 How to use preset profiles 13
6.4 Configuring the user inputs on the handles and foot
switches 14
7 Modifying the GLOW400 settings 18
7.1 Excitation intensity 18
7.2 Fluorescence visibility 19
8 Operation 20
8.1 Operating range limits for GLOW400 20
8.2 Preoperative checklist 20
8.3 Test standard 21
8.4 Test card preoperative check 21
8.5 Using the GLOW400 23
9 Recording in fluorescence mode 24
9.1 Recording 24
9.2 Taking pictures 25
9.3 Playback 25
9.4 Export 26
10 Care and maintenance 27
11 What to do if...? 28
11.1 General 28
11.2 Issue List 28
11.3 Common troubleshooting steps 29
12 Technical data 31
12.1 Technical data of GLOW400 31
12.2 Compatibility 31
12.3 Ambient Conditions 31
13 Manufacturer's declaration of electromagnetic
compatibility (EMC) 32

Introduction
2 GLOW400 / Ref. 10 748 697 / Version 01
1 Introduction
1.1 About this user manual
GLOW400 is a digital accessory for the ARveo 8 surgical microscope.
In this user manual the functions of the GLOW400 are described. For
information and description of the surgical microscope, refer to the
user manual of ARveo 8.
In addition to notes on the use of the instruments
this user manual gives important safety information (see
chapter 2"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.
2 Safety notes
X Always follow the instructions in this user manual and in the
user manual of the Leica surgical microscope, and in particular
the safety notes.
2.1 Intended use
GLOW400 is a digital surgical microscope accessory for viewing
fluorescence of fluorophores with an excitation peak between
380nm and 430nm and an observation comprising the long-wave
blue, green, yellow and red spectrum in the spectral band greater
than 444nm. GLOW400 is intended for visualization of fluorescence
with improved visualization of the anatomical background and for
visualization of the enhanced fluorescence contrast.
WARNING
X GLOW400 shall only be used with appropriate
fluorescence media, i.e. fluorophores approved for use
within the specified spectral ranges.
2.2 Indications for use
GLOW400 is a digital surgical microscope accessory used in
fluorescent visualization of suspected grade III or IV gliomas during
neurosurgery.
WARNING
GLOW400 is not a standalone diagnostic device.
2.3 Intended User
GLOW400 is intended for professional use only. The user must have
corresponding technical qualification and have been trained in the
use of the instrument.
2.4 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 ARveo 8 with
GLOW400 in combination with fluorescence media are those to be
taken into account when using suitable brand substances.

Safety notes
GLOW400 / Ref. 10 748 697 / Version 01 3
2.5 Dangers of use
CAUTION
Surgery is interrupted.
X Perform the preoperative check to conrm GLOW400 is
working as intended (see chapter 8.2"Preoperative
checklist").
CAUTION
Caution to the user.
X Use only compatible 3D glasses provided by Leica
Microsystems.
X Do not use 3D glasses on 2D monitor
X Check the perception of the 3D view prior to surgery. If
you do not feel condent with the 3D view, switch to 2D
view.
WARNING
Risk of infection.
X The 3D glasses must not be touched by sterile personnel.
X Do not use the GLOW400 test card in the sterile eld.
WARNING
Risk of injury to patient.
X Medical device is to be used only by trained personnel.
X Danger of injury to the patient due to excessive
GLOW400 radiation.
WARNING
Risk of compromised decision making.
X Residual fluorescence is checked at the end of surgery by
using GLOW400 Highlighted Fluorescence view on
monitor.
X Change the angle of the IGS camera to prevent pulsation
interferences on monitor when IGS system is activated.
WARNING
Risk of compromised surgery.
X Use FL400 in case GLOW400 does not work as intended.
X Use White Light or GLOW400 Anatomy to visualize
peripheral view and/or surrounding anatomy.
X Minimize the ambient light during GLOW400 surgery to
avoid noise and incorrect information on monitor.
X Perform 3D heads-up visualization check prior to
surgery to conrm correct and stress-free visualization
is achieved.
X Use only compatible monitors provided by Leica
Microsystems.

Safety notes
4 GLOW400 / Ref. 10 748 697 / Version 01
2.6 Directions for the person
responsible for the instrument
WARNING
Risk of injury to patient.
X Medical device is to used only by trained personnel.
X Ensure that this user manual is always available at the place
where the GLOW400 is in use.
X Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
X When instructing new users, do so thoroughly and explain
themeanings of the warning signs and messages.
X Allocate responsibilities for commissioning, operation and
maintenance. Monitor compliance with this.
X Only use the GLOW400 when it is free of defects.
X Inform your Leica representative or Leica Microsystems
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
immediately about any product defect that could potentially
cause injury or harm.
X Report any serious incident in relation to the GLOW400 or
surgical operating microscope system it is used with to your
Leica representative or Leica Microsystems (Schweiz) AG,
Medical Division, 9435 Heerbrugg, Switzerland, and to your
competent authority immediately after it has occurred.
Prerequisite to use GLOW400 is to have the GLOW400 and
FL400 licenses installed.
X Ensure that the GLOW400, FL400 and ARveo 8 user
manuals are available at the place where the GLOW400
is in use.
2.7 Signs and labels
The labels are located on the back of the ARveo 8 stand.
1Type 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
GLOW400 / Ref. 10 748 697 / Version 01 5
3 Description
3.1 Function
The illumination for the GLOW400 is a xenon lamp located in the
stand of the ARveo 8. This lamp provides visible and fluorescence
excitation light.
To switch between visible (white) light and fluorescence mode
illumination, a handle and/or foot switch button has to be defined
in the user settings for each GLOW400 surgeon profile (see chapter
6.4.1"Example of how to assign the GLOW400 function to a handle
button").
3.2 Design
GLOW400 is a digital accessory for the ARveo 8 surgical microscope
to acquire stereoscopically fluorescence and anatomical background
information being then displayed in 2D or 3D on a visualization
device, i.e., monitor.
3.2.1 ARveo 8 with GLOW400 and related
accessories
There are 3 different configurations for GLOW400 digital accessory
visualization with the ARveo 8:
1. 2D stand monitor with 3D external monitor on a cart
2. 3D stand monitor with 3D external monitor on a cart
3. 3D stand monitor only
3
4
2
1
5
1 M530 Optics Carrier
2 Stand monitor 2D or 3D
3 Control unit with touch panel (GUI)
4 Illumination unit
5 External Monitor on cart
WARNING
Risk of compromised surgery.
X Use only compatible monitors provided by Leica
Microsystems.

Controls
6 GLOW400 / Ref. 10 748 697 / Version 01
4 Controls
GLOW400 activation sequence:
X First activate FL400 through preassigned button of
handles or foot switch.
X Finally activate GLOW400 through preassigned button
of handles or foot switch.
4.1 Handles
1
2
4
3
5
4
1
2
Factory default assignments
1 Magnification
2 4-function joystick
3 Working distance
4 Release all brakes
5 Release preselected brakes
It is possible to assign functions to switches (1), (2), (3)
and(5) of the handles individually for each surgeon profile
in the configuration menu.
In all profiles, key (4) releases all brakes. This key cannot be
configured. For the joystick and the other keys presets are
available according to your task.
4.2 Foot switch
Foot switch, 12 functions (Individually assignable)
1 1
6
7
8
9
2
3
4
5
Y+
Y–
X– X+
1 No function
2 Lamp +
3 Working distance –
4 Magnification +
5 not assigned
6 Lamp –
7 Working distance +
8 Magnification –
9 not assigned
The foot switch can be assigned individually for each user in
the configuration menu (see chapter 6.4"Configuring the
user inputs on the handles and foot switches").
There is no default factory setting for GLOW400 activation/
deactivation. It must be assigned manually following
assignment of the FL400 activation/deactivation function.
For information about how to assign GLOW400 functions to
the handles (see chapter 6.4.1"Example of how to assign
the GLOW400 function to a handle button").

Visualization
GLOW400 / Ref. 10 748 697 / Version 01 7
4.3 Status LEDs
The LEDs located on the microscope carrier of the stand are in the
near sight of the surgeon and inform about the fluorescence and
recording status of the microscope.
1
2
1 Status LED for fluorescence
2 Status LED for recording
The fluorescence status LED (1) indicates the fluorescence activity:
Off: no fluorescence,
white light mode
Blue : FL400 is activated
Cyan: FL560 is activated
Magenta: GLOW800 is activated
The status LED for recording (2) light up in
Red: Recording in progress
Green: GLOW800 Playback in progress
5 Visualization
5.1 Overview
Throughout the user manual we define fluorophore as follows:
Fluorescent substances with an excitation peak between 380 nm –
430 nm and an observation comprising the long-wave blue, green,
yellow, and red spectrum in the spectral band greater than 444 nm,
e.g. 5-ALA.
The optional accessory GLOW400 for ARveo 8 surgical microscope
enables the surgeon to excite with blue light and observe
fluorescence (FL) of the fluorophore on a monitor with improved
visualization of the anatomical background (GLOW400 Anatomy)
and with visualization of enhanced fluorescence contrast (GLOW400
Highlighted Fluorescence) (see chapter 5.3"GLOW400 visualization
types").
A prerequisite to use GLOW400 is to have FL400 already
installed and license activated with blue light visualization
being shown on the monitors (see chapter 6.4.1"Example of
how to assign the GLOW400 function to a handle button").

Visualization
8 GLOW400 / Ref. 10 748 697 / Version 01
5.2 2D and 3D view
3
4
2
1
5
The optional Heads-up Microsurgery accessory for ARveo 8 Leica
surgical microscope system displays the surgical field in 2D or 3D
(stereoscopic) on a visualization device.
The technology provides ergonomic advantages as the user can
maintain an upright posture while observing the surgical field.
The Heads-up Microsurgery accessory contains a cart-mounted
monitor, which can be flexibly positioned to achieve optimal
viewing positions. (Please see the Heads-up Microsurgery
equipment user manual).
The external monitor on cart (5) can display a stereoscopic 3D image
when used in conjunction with 3D glasses.
The stand monitor (2) can be supplied as 2D or 3D capable only
depending on your selected configuration.
The 3D capable monitors automatically switch between 2D
and 3D mode when required by the visualization.
WARNING
Risk of compromised surgery.
X Use only compatible monitors provided by Leica
Microsystems.
3D glasses
With the external 3D Video Monitor on cart and the 3D stand
monitor, the below 3D glasses are provided
Leica Microsystems supplied glasses 10747283
Plastic frame glasses
Clip-on goggles
CAUTION
Caution to the user.
X Use only compatible 3D glasses provided by Leica
Microsystems.
CAUTION
Caution to the user.
X Check the perception of the 3D view prior to surgery. If
you do not feel condent with the 3D view, switch to
FL400.
CAUTION
Caution to the user.
X Do not use 3D glasses on 2D monitor
WARNING
Risk of infection.
X The 3D glasses must not be touched by sterile personnel.

Visualization
GLOW400 / Ref. 10 748 697 / Version 01 9
5.3 GLOW400 visualization types
GLOW400 offers two different visualization types to observe the fluorescence signal and/or surrounding anatomical structures.
WARNING
Risk of compromised surgery.
X Use White Light or GLOW400 Anatomy to visualize peripheral view and/or surrounding anatomy.
GLOW400 Anatomy GLOW400 Highlighted Fluorescence (HiFluo)
Improved visualization of the anatomical background with the
embedded fluorescence signal:
Highlighted Fluorescence on a black background:
Both visualization types are visible on the monitors or other connected visualization devices.

Visualization
10 GLOW400 / Ref. 10 748 697 / Version 01
5.4 GLOW400 visualization
arrangements
GLOW400 provides two visualization arrangement types:
• Mono-view (only one visualization in full screen)
• Side-by-side-view (two visualization simultaneously side-by-
side)
Blue light visualization is combined with GLOW400
visualization types in side-by-side views.
The system toggles through the following predefined output views
in the provided order when pressing the predefined GLOW400
toggle button (see chapter 6.4.1"Example of how to assign the
GLOW400 function to a handle button").
1. Mono view: GLOW400 Anatomy
2. Mono view: GLOW400 Highlighted Fluorescence
3. Side-by-side view: Blue light / GLOW400 Anatomy
4. Side-by-side view: GLOW400 Anatomy /GLOW400 Highlighted
Fluorescence
5. Side-by-side view: GLOW400 Highlighted Fluorescence / Blue
light
Each output view is a selection of visualization type(s) and the
arrangement of type(s) (e.g. mono view or side-by-side view). When
reaching the last output view and the predefined GLOW400 toggle
button is pressed again, the GLOW400 visualization is deactivated
and the blue light visualization of FL400 is shown on the monitors.
An indication of GLOW400 product appears in the bottom right
corner on the monitor as depicted above.

Preparation before surgery
GLOW400 / Ref. 10 748 697 / Version 01 11
6 Preparation before surgery
For more information about preparation before surgery,
refer to the usermanual of ARveo8.
6.1 Creating a surgeon profile
6.1.1 Creating a new surgeon profile with factory
default settings
1
X Tap the "Data review" (1) icon on the GUI "Live Screen" page.
The following menu appears:
2
X Press "New Surgery" (2).
The "Select Surgeon" page appears.
3
X Tap the "Create New" button (3).
The "Create New Surgeon Profile" page is displayed:
4 5
X Fill in at least the mandatory data for a surgeon profile, i.e. first
name and a unique three-letter acronym.
Fields marked with an * 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 and can
contain maximum ten (10) characters.
X Press either "Copy" (4) or "Create New" (5) .
The "Create New" function allows to start from default factory
settings.
The "Copy" function (see chapter 6.1.2"Creating a new surgeon
profile from an existing surgeon profile or preset") allows to
copy settings from a preset or an existing surgeon profile which
can then be adapted to your needs.

Preparation before surgery
12 GLOW400 / Ref. 10 748 697 / Version 01
6.1.2 Creating a new surgeon profile from an
existing surgeon profile or preset
When the "Copy" function is used (see chapter 6.1.1"Creating a new
surgeon profile with factory default settings"), the list of existing
surgeon profiles and presets is displayed.
The GLOW400 user can chose a surgeon profile for which the
GLOW400 profile has already been defined or choose the FL400
preset profiles _Tumor or _Tumor+IGS.
The factory preset profiles are displayed at the top and are
generally prefixed with an underscore (i.e. _Tumor).
X Select the desired preset or surgeon profile to copy.
X Press "OK".
In both cases (copying preset or copying an existing surgeon
profile), after pressing OK, the name of a surgeon profile
specified on the "Create New Surgeon Profile" page (see chapter
„6.1.1 Creating a new surgeon profile with factory default
settings“, page 11) appears on the "Live Screen" on the top
right with the copied settings.
X Configure the user input settings (see chapter 6.4.1"Example of
how to assign the GLOW400 function to a handle button").
6.2 Select an existing surgeon profile
X Open "Select surgeon" page (see chapter „6.1.1 Creating a new
surgeon profile with factory default settings“, page 11).
X Choose between different surgeon profiles from the "wheel".
1
23
If more than 5 profiles have been defined, the user can rotate
through all defined and activated profiles by dragging with their
finger. Profiles are alphabetically sorted by first name. The list is
"infinite", i.e. after the last item in the list, the first item will appear
as the next one. If there are less than 4 profiles, there is no need or
option to drag.
Tapping on one of the surgeon profiles opens the "Live Screen"
page and the name of a chosen surgeon profile appears on the top
right.
When the user taps "Default" (3) or "Skip to Live Screen"(1), the
default surgeon profile is chosen. Any changes to the default
settings are applied immediately, but will not be stored. i.e., the
next surgery using this default profile will start with the original
factory settings again.
When the user taps "Show preset profiles" (2), a list of preset
profiles appears, depending on the installed licenses.

Preparation before surgery
GLOW400 / Ref. 10 748 697 / Version 01 13
6.3 How to use preset profiles
X Open "Select Surgeon" page (see chapter 6.1.1"Creating a new
surgeon profile with factory default settings").
X Tap "Show preset profiles".
The following page appears:
For more information about preset profiles, see the
ARveo 8 user manual.
X Select the desired default profile. For GLOW400 users select
"_Tumor" or "_Tumor+IGS".
The following warning screen appears:
1
X Press "OK" (1).
The selected profile is shown on the "Live Screen" page.
X Configure the user input settings (see chapter 6.4.1"Example of
how to assign the GLOW400 function to a handle button").
The preset profile can be used and modified, but any
changes to the profile settings will not be saved. Therefore,
with each new start-up, the default profile settings will be
restored.
Since the modifications to the preset cannot be saved, it is
highly recommended to create a new surgeon profile for a
full workflow where a preset can be used as a starting
point.

Preparation before surgery
14 GLOW400 / Ref. 10 748 697 / Version 01
6.4 Configuring the user inputs on
the handles and foot switches
X Make sure you are on the "Live Screen" page for the selected or
newly created surgeon profile.
1
X Tap the menu icon in the upper left corner(1).
The "Options" page is displayed:
2
X Tap the "Surgeon Settings" icon (2).
The "Surgeon Settings" page is displayed:
3
X Tap "Handles" button (3) to show the "Left Handle" settings.
Depending on the surgeon profile that is set ("new surgeon
profile with factory default settings" or "new surgeon profile
from an existing surgeon profile or preset") the left and right
handle display will differ. If using "new surgeon profile with
factory default settings", the predefined factory settings of the
left handle are displayed:
3
X Press on "Right" for the right handle configuration screen.
Predefined factory settings of the right handle are displayed:
Now the handle settings can be viewed or edited for the
selected surgeon profile.

Preparation before surgery
GLOW400 / Ref. 10 748 697 / Version 01 15
6.4.1 Example of how to assign the GLOW400
function to a handle button
FL400 mode activation is a prerequisite to enable GLOW400
functionality on the microscope. The following steps show how the
GLOW400 toggle function can be assigned to a button i.e., on the
left handle, first by assigning FL400 activation/deactivation
functionality to the handle.
The preset for FL400 can be used to quickly assign the FL400
functionality to a predefined handle button (see chapter
6.1.2"Creating a new surgeon profile from an existing surgeon
profile or preset"), but this can be done also manually choosing any
of the available buttons.
The GLOW400 toggle function needs to be assigned manually to
any of the buttons of the handle.
X Open the settings page for the handle you wish to configure (in
this example the "Left Handle" settings page) as described in
chapter 6.4 after having switched to the particular surgeon
profile you wish to edit (see chapter 6.2):
1
X When you are on the handle configuration page, press the
button you want to assign for the activation of the GLOW400
toggle. In this example we select the right button of the joystick
(1).
The "Select function" popup window for the selected button
appears:
2
X Select the "Fluorescence" tab (2).
A list of available FL functions appears.
34
X Select the GLOW400 toggle function (3) and press "Confirm" (4)
to save the settings.
The GLOW400 toggle function is assigned to the selected
button as displayed:

Preparation before surgery
16 GLOW400 / Ref. 10 748 697 / Version 01
Deleting a function assignment
X In case the selected function needs to be deleted, press the
function button on the handle configuration page.
The "Select function" popup window for the selected button
appears:
5
X Press the "Delete" button (5).
The selected function disappears from settings of the handle
configuration page.
X Press the "Back" button of the handle configuration page.
The "Save Surgeon Settings" dialog appears.
X Press desired option.
The "Surgeon Settings" appear.
X Press "Back" to return to the "Options" page.
This process can also be used for any of the buttons to which
you wish to assign any other function.
To switch to the white light mode, deactivate FL400 mode.
6.4.2 Configuring the foot switch
You can configure the foot switch similarly to the handles.
X Ensure you have loaded the surgeon profile you wish to edit
(see chapter 6.2).
X Open the "Foot Switch" settings page in the "Options" ->
"Surgeon Settings" page.
X Tap the selection field of the desired key on the foot switch.
The following selection menu opens:
12
X Select the desired function (1) and apply with Confirm (2).
The selected function is displayed in the selection field.
The selections are identical to those for the handles with the
exception of the brakes.

Preparation before surgery
GLOW400 / Ref. 10 748 697 / Version 01 17
Example of foot switch with GLOW400 assignment

Modifying the GLOW400 settings
18 GLOW400 / Ref. 10 748 697 / Version 01
7 Modifying the GLOW400
settings
7.1 Excitation intensity
The excitation intensity is linked to Leica FL400 product. Please
refer to Leica FL400 user manual on how to change this default
excitation intensity. Per default this excitation value is set to 100%
(see recommended excitation settings).
1
X Tap the menu icon (1) in the upper left corner of the "Live
Screen" page.
The "Options" page is displayed:
2
X Tap the "Surgeon Settings" icon (2).
The "Surgeon Settings" page is displayed:
3
X Tap the "Fluorescence Settings" (3) icon and then tap the FL400
tab (4).
The FL400 "Fluorescence Settings" page is displayed:
46 5
Recommended Excitation settings
To achieve good fluorescence visibility in higher magnifications and
working distances the default and recommended "Excitation"
setting (5) is 100%.
X Adapt the "Excitation" setting using the slider (5).
X Press "Back" (6).
If the excitation setting was modified, the "Save Surgeon
Setting" is displayed: