Leica GLOW400 Bedienungsanleitung

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: +41 71 726 3333

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)

REF

Fabrication label

a Reference number

b Serial number

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

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

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

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 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

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.

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