Leica GLOW800 User manual

MEDICAL DIVISION
User Manual
10 747 241 - Version 00
GLOW

II GLOW800 / Ref. 10 747 241 / Version 00
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.

GLOW800 / Ref. 10 747 241 / Version 00 1
Contents
1 Introduction 2
1.1 About this user manual 2
1.2 Symbols in this user manual 2
2 Safety notes 3
2.1 Intended use 3
2.2 Dangers of use 3
2.3 Information for the person responsible for the
instrument 3
2.4 Signs and labels 3
3 Description 4
3.1 Function 4
3.2 Design 4
4 GLOW800 System Components - Signal overview 6
5 GLOW800 image injection 7
6 Description 7
6.1 Function 7
7 Controls 10
7.1 Handles 10
7.2 Status LEDs and Display 10
8 Preparation before surgery 12
8.1 Adjustments 12
8.2 GLOW800 User settings menu 14
8.3 User settings camera 18
9 Check the illumination and function & adjustement
20
9.1 Test card 20
9.2 Preparation 20
9.3 Pre-operation checklist (GLOW800) 21
9.4 Test card functional areas 22
10 Operation 23
10.1 Using the GLOW800 23
10.2 Controlling the GLOW800 functions 23
11 Care and maintenance 24
12 Disposal 24
13 What to do if...? 24
13.1 General 24
13.2 GLOW800 24
14 Technical data 26
14.1 Technical data GLOW800 26
14.2 Compatability 26
14.3 Ambient conditions 26
14.4 Standards fulfilled 26
15 Manufacturer's declaration of electromagnetic
compatibility (EMC) 27

Introduction
2 GLOW800 / Ref. 10 747 241 / Version 00
1 Introduction
1.1 About this user manual
The GLOW800 is an accessory for Leica surgical microscopes.
In this user manual the functions of the GLOW800 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.
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.

Safety notes
GLOW800 / Ref. 10 747 241 / Version 00 3
2 Safety notes
A Leica surgical microscope with GLOW800 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.
 Federal Law restricts this device to sale by or on the order of a
licensed medical practitioner.
2.1 Intended use
• The GLOW800 is a Leica surgical microscope accessory used in
viewing intra-operative blood flow in the cerebral vascular area
and bypass grafts during coronary artery bypass (CABG)
surgery, as well as blood flow during plastic and reconstructive
surgery.
Contraindication
• The medical contraindications applicable to the use of the
Leicasurgical microscope with GLOW800 in combination with a
fluorescence medium are those to be taken into account when
using suitable brand substances and state-of-the-art
examination techniques.
WARNING
Danger of injury to the eyes.
 Do not use GLOW800 in ophthalmology.
2.2 Dangers of use
WARNING
Risk of infection due to insterile MFL800 test card.
 Do not use the MFL800 test card in the sterile eld.
 Use only in non-sterile environment.
WARNING
User selected with a programmed uorescence function.
 Correct user is activated.
 Preperational check is performed.
 Microscope illumination lamp is within tolerances (see
user manual of the Leica surgical microscope).
WARNING
Risk of infection due to insterile MFL800 test card.
 Check the microscope illumination in non-sterile
environment only.
WARNING
Danger of injury to the patient due to not approved
uorescence media.
 Only use fluorescence media approved for the planned
application.
WARNING
Danger of injury to the patient due to excessive GLOW800
radiation.
 Avoid extended and/or excessively frequent use of
GLOW800 radiation.
 GLOW800 mode is disabled automatically no later than
after 180 seconds to prevent excessive exposure of the
patient to GLOW800 radiation.
2.3 Information for the person
responsible for the instrument
 When using GLOW800 please ensure to have a Doppler
Ultrasound or similar in place, in case of none or insufficient
blood flow visualization out of the ICG/GLOW800 procedure is
given.
2.4 Signs and labels
Type label

Description
4 GLOW800 / Ref. 10 747 241 / Version 00
3 Description
3.1 Function
The illumination for the GLOW800 is a xenon lamp and is located in
the Leica surgical microscope. This lamp provides visible and near
infrared light. This light cannot be observed through the surgical
microscope, but it is recorded using a special camera and visualized
on the monitor mounted on the Leica surgical microscope.
Using the handles or via user settings you can switch between
visible and GLOW800 light.
Please refer to the user manual of the corresponding Leica
surgical microscope.
3.2 Design
GLOW800 is an accessory to the Surgical Operating Microscope and
is incorporated into the M530 optics carrier.
GLOW800 is composed of the following components:
A GLOW800 ULT, see chapter 3.2.1, position (1)
B GLOW800 VPU, see chapter 3.2.2, position (3)
C GLOW800 filters, see chapter 3.2.2, in position (4)
3.2.1 M530 optics carrier with GLOW800




1 GLOW800 ULT
2 Image Injection module Leica CaptiView (optional)
3 Fluorescence module Leica FL400, FL560 or FL400/560 (optional)
4 M530 Optics Carrier





1 Interface for lateral left and right assistant
2 Interface for back/opposite assistant, 360° rotatable
3 Back assistant fine focus
4 Switch lateral or back assistant
5 Interface main surgeon, 360° rotatable
• GLOW800 is built into the housing of the ULT530
• Integrated cameras for visible light and for NIR light
(fluorescence), one common remote controlled fine focus for
both

Description
GLOW800 / Ref. 10 747 241 / Version 00 5
3.2.2 Leica OHX surgical microscope with
GLOW800 components
2
1
3
4
5
1 Monitor (optional)
2 GUI screen
3 GLOW800 VPU (see chapter 3.2.3)
4 Illumination unit with GLOW800 filters
5 Surgeon panel
3.2.3 GLOW800 VPU
VPU Reset
HD-SDI 2
HD-SDI 1
1 Video signal output 1
2 Video signal output 2
3 Reset button to reboot/reset of the system
4 Documentation system (optional)
3.2.4 Leica OH6 surgical microscope with
GLOW800 components
1
5
2
3
4
1 Monitor (optional)
2 GUI screen
3 GLOW800 VPU (see chapter 3.2.3)
4 Illumination unit
5 Status LED

GLOW800 System Components - Signal overview
6 GLOW800 / Ref. 10 747 241 / Version 00
4 GLOW800 System Components - Signal overview
WL/FL
WL/FL
WL /FL
GLOW800
3 HD
cameras
acquires right WL
and FL video
signal
3 Video signals
WL Left
WL Right
FL GLOW800
VPU
Optional
2D/3D
Recording
Unit
records both
signals
Leica
Microscope
Monitor
displays one
signal fullscreen
or both in
picture-in-
picture
GUI
GLOW800 service
and user settings
2 Video signals 2 Video signals
3D visualization is only for teaching purposes not intended
for heads-up surgery.

GLOW800 image injection
GLOW800 / Ref. 10 747 241 / Version 00 7
5 GLOW800 image injection
If an optional CaptiView image injection system is integrated into
the surgical microscope M530 OH6 and M530 OHX, the fluorescence
information can be observed in the right eyepiece, according to the
selected fluorescence observation type.
(Observation Type A)
White light image with embedded fluorescence in pseudo color
video*
(Observation Type B)
Black&White fluorescence video*
Please refer to the usermanual of the corresponding Leica
image injection system (CaptiView).
* Disclaimer: Representative pictures.
6 Description
6.1 Function
The optional accessory GLOW800 enables the surgeon to excite and
observe Near Infrared (NIR) fluorescence (FL) of the fluorophore
(ICG) with the surgical microscopes M530 OH6 and M530 OHX.
When activating the GLOW800 mode, the white light illumination of
the Leica microscope stand (Leica OH6 or OHX) is extended to
InfraRed (IR), to excite the fluorophore (ICG).
The filtered NIR fluorescence signal of the fluorophore (ICG) is
acquired by a NIR sensitive video camera in the GLOW800 ULT and
processed in the GLOW800 VPU.
6.1.1 Fluorescence observation on the microscope
video monitor
GLOW800 offers two different types to observe the fluorescence
video signal on an attached Leica surgical microscope video
monitor (optional):
White light object view with the embedded fluorescence signal in
pseudo color:
White light fluorescence observation
(WL/FL) Standard
Black&White (B&W) fluorescence view e.g. with GLOW800:
Black&White fluorescence observation
(B&W/FL)

Description
8 GLOW800 / Ref. 10 747 241 / Version 00
6.1.2 Fluorescence observation and recording with a documentation system
The GLOW800 VPU generates two videos which can be recorded by an optional documentation system, e. g. HDMDPRO, if integrated into
the surgical microscope.
The following recording and visualization settings can be predefined on an optional documentation system. The records and display are
done in the following way:
White light fluorescence observation (WL/FL) with Black & White fluorescence observation (B&W/FL)
GLOW800 Image processing
Two provided videos for visualization and recording
Main video 1 2nd video
Viewing and Recording
Setting 1
One video view on the video monitor, both videos are
recorded
Main video 1 2nd video
Setting 2
Picture-in-Picture view on the video monitor, both videos are
recorded
Main video 1 = full screen, 2nd
video = window
2nd video = full screen,
main video 1 = window
Setting 3
Side-by-Side view on the video monitor, both videos are
recorded
Left = video 1,
right = 2nd video
Left = 2nd video video 1,
right = video 1

Description
GLOW800 / Ref. 10 747 241 / Version 00 9
The GLOW800 VPU generates two videos which can be recorded by an optional documentation system if integrated into the surgical
microscope.
The records and visualization are done is the following way:
Black & White fluorescence observation (B&W/FL) with white light fluorescence observation (WL/FL)
GLOW800 Image processing
Two provided videos for visualization
and recording
Main video 1 2nd video
Viewing and Recording
Setting 1
One video view on the video monitor, both videos are recorded
Main video 1 2nd video
Setting 2
Picture-in-Picture view on the video monitor, both videos are
recorded
Main video 1 = full screen,
2nd video = window
2nd video = full screen,
main video 1 = window
Setting 3
Side-by-Side view on the video monitor, both videos are
recorded
Left = video 1,
right = 2nd video
Left = 2nd video video 1,
right = video 1
The documentation system replay function allows to observe the fluorescence video once or steadily in the same way as it was displayed
before or during the record (first video). Additionally, the second recorded video can be selected for observation, either as main video
source or as a picture-in-picture (PIP) or side-by-side (SBS).
Please refer to the documentation device manuals for further information.

Controls
10 GLOW800 / Ref. 10 747 241 / Version 00
7 Controls
7.1 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 GLOW800
Step Loop
left handle right handle
GLOW800
On/O
Play-
back
Y+
Y–
X– X+
It is recommended to use the 4-function joystick (2) to control the
GLOW800 as it is defined in the GLOW800 preset, although you can
assign the switches 1, 2, 3 and 5 of the handles individually in the
configuration menu to fit the needs of each user.
In all presets, switch (4) releases all brakes. This switch cannot be
configured differently.
7.2 Status LEDs and Display
The LEDs located on the C-arm of the stand are in the near sight of
the surgeon and inform about the fluorescence and recording status
of the microscope:
7.2.1 Leica OH6 - Status LED
1
2
1 Status LED for fluorescence
2 Status LED for recording
The fluorescence status LED (1) indicates the fluorescence mode
selection.
white: no fluorescence,
white light mode
blue : FL400 mode active
cyan: FL560 mode active
yellow: FL800 mode active
magenta: GLOW800 mode active
The status LED for recording (2) light up in
red: GLOW800 loop recording in progress
green: GLOW800 replay mode

Controls
GLOW800 / Ref. 10 747 241 / Version 00 11
7.2.2 Leica OHX surgeon panel
The surgeon panel indicates the fluorescence mode selected and
on/off status.
4
3
12
5
1 Fluorescence icon
2 Fluorescence mode color bar
3 Documentation icon
4 Replay icon
5 Recording icon
The fluorescence status color bar (4) indicates the fluorescence
mode selection.
white light: no fluorescence,
white light mode
blue: FL400 mode active
cyan: FL560 mode active
yellow: FL800 mode active
magenta: GLOW800 mode active
 If the optional recording system is integrated into the
microscope system, the recording icon (5) will change from
black to red if the GLOW800 NIR video sequence (loop) is
recorded.
 The replay icon (4) stays black.
 In replay mode the replay icon (4) becomes green and the
recording icon (5) stays black (see below).

Preparation before surgery
12 GLOW800 / Ref. 10 747 241 / Version 00
8 Preparation before surgery
8.1 Adjustments
8.1.1 Adjustments on the M530 control unit for
GLOW800
Ensure that the GLOW800 accessories are enabled.
Please contact your Leica representative for further
assistance.
Using the "Fluorescence Vascular GLOW800" user preset
 In the Main menu click on the "Preset" button.
The availbale presets are displayed.
Select the "Fluorescence Vascular GLOW800" user preset.
 Click on the "Select" button.
The selected user preset is displayed in the status line.
Handle assignment
 In the Main menu click on the "Show Settings" button.
 Select the "Handle Left" or "Handle Right" tab.
You see an overview with which buttons of the left handle the
GLOW800 functions can be operated.

Preparation before surgery
GLOW800 / Ref. 10 747 241 / Version 00 13
Modifying the "Fluorescence Vascular GLOW800" user preset
If you adjusted the settings of the "Fluorescence Vascular
GLOW800" 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 GLOW800 user
 Click on the "Menu" quick access button (1).
1
 Select "UserSettings".
 Select "New User".
 Open the "Handle Left" or "Handle Right" tab to assign
GLOW800 functions to the handle.
 In the left selection field, select the "Fluorescence" function
group by clicking on it.
 Assign the function "GLOW800 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.
 Repeat this process for the function "docu FL: playback".
 Click on "Save".
 Select an empty position in the user list.
 Enter the desired user name via the keyboard, e.g. "ICG User".
 Click on the "Save" button to save your settings under the user
name entered at the desired location.

Preparation before surgery
14 GLOW800 / Ref. 10 747 241 / Version 00
Brightness
In the service menu, you can adjust a value for the
maximum duration of the GLOW800 mode from 10 to
180seconds.
 Open the "FL" tab to set the brightness in GLOW800 mode to an
adequate level.
Note
We recommend to set the brightness to 100% (Default).
 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 GLOW800 mode, the working distance
will be reduced and the picture will get out of focus.
8.2 GLOW800 User settings menu
The tab offers specific GLOW800 settings for each user:
8.2.1 Output mode
With «output mode» one of two types of fluorescence observation
can be chosen:
• White light object view with the embedded fluorescence signal
in pseudo color (white light fluorescence observation = WL/FL)
• Standard Black&White fluorescence view (Black&White
fluorescence observation = B&W/FL)
See as well Chapter 6.1.1, page 7

Preparation before surgery
GLOW800 / Ref. 10 747 241 / Version 00 15
8.2.2 Threshold
With «threshold» the fluorescence intensity level can be chosen from which on the fluorescence signal is displayed in the white light
fluorescence and Black&White fluorescence view.
Selectable threshold values range from:
0% = display of the full range of low to high intensity fluorescence signals to 100% = just high intensity fluorescence signals.
Using the test card demonstrates how the «threshold» function influences the fluorescence signal.
Threshold at 0% - all fluorescence intensities are displayed
Leica MFL800 Standard
Please read the Leica
MFL800 user manual!
!
10 746 513-01
01 2 3 4 5 6 7 8 9
A A
Black&White fluorescence observation
(Video monitor)
White light fluorescence observation
(Video monitor)
Threshold at 100% - middle to high intensity is displayed only
Leica MFL800 Standard
Please read the Leica
MFL800 user manual!
!
10 746 513-01
01 2 3 4 5 6 7 8 9
A A
Black&White fluorescence observation
(Video monitor)
White light fluorescence observation
(Video monitor)
Reference section 9 for test card details.

Preparation before surgery
16 GLOW800 / Ref. 10 747 241 / Version 00
8.2.3 Color
With «color» the pseudo color of the fluorescence signal can be chosen.
Selectable color values are from 1=magenta to 7=chartreuse. The chosen color defines the appearance of the fluorescence on top of the
white light image to optimize the color contrast between the colors of the object in white light and the fluorescence signal.
color color name RGB value
1magenta 255-000-255
2violet 127-000-255
3 blue 000-000-255
4azure 000-127-255
5dark cyan 000-221-221
6green 000-255-000
7chartreuse 127-255-000
8
9
Displaying the fluorescence with color #5 - dark cyan in white light
fluorescence observation #5 is the default color in the GLOW800
preset (Video monitor)
Displaying the fluorescence with color #1 – magenta in white light
fluorescence observation (Video monitor)
Leica MFL800 Standard
Please read the Leica
MFL800 user manual!
!
10 746 513-01
01 2 3 4 5 6 7 8 9
A A
Leica MFL800 Standard
Please read the Leica
MFL800 user manual!
!
10 746 513-01
01 2 3 4 5 6 7 8 9
A A

Preparation before surgery
GLOW800 / Ref. 10 747 241 / Version 00 17
8.2.4 Intensity
«Intensity» adjusts the fluorescence contrast, brightness and
transparency in relation to the object details.
The intensity values range from 0% to 100%. Fluorescence is
visible across the full percentage range. E.g. at 0% intensity
fluorescence is just visible with the object dominant, at 100%
intensity fluorescence is intensively visible and dominant.
Minimum intensity setting – 0%
Medium intensity setting – 50%
Maximum intensity setting – 100%
8.2.5 Apply button
By pressing the "Apply" button on the GLOW800 page of the user
settings changes of one or more of the different GLOW800 settings
become active in the GLOW800 system.
The result of the changed settings can be observed after a few
seconds on the GLOW800 screen.

Preparation before surgery
18 GLOW800 / Ref. 10 747 241 / Version 00
8.3 User settings camera
8.3.1 Digital zoom
With «digital zoom» the display format is adjusted to the needs of
each GLOW800 user. There are three formats available:
Max. Height:
fits the maximum detected field of view on the screen of the
documentation monitor
 nearly round image format – full video resolution
Full width
fits the full horizontal field of view on the screen of the
documentation monitor
 format with rounded edges – full horizontal video resoltion
Full screen:
fits the diagonal of the field of view into the diagonal of the screen
of the documentation monitor
 rectangular image format – reduced video resolution
8.3.2 Exposure
"Exposure" defines the shutter speed for the white light camera.
If set to "Auto" the shutter speed is selected automatically by the
camera to receive best brightness and contrast of the image
(default setting).
To enforce a specific shutter speed the setting can be changed from
"Auto" to manually selectable shutter speed values, selectable in
steps from 1/60 to 1/10000.