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