Leica GLOW800 Manual de usuario

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: +41 71 726 3333

Fax: +41 71 726 3334

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

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

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 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

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

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