leica fl400 for m530 fl400/user... · 2021. 5. 17. · leica fl400 for m530 / ref. 10 744 764 /...

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User Manual

10 744 764 - version 02

Leica FL400 for M530

ii leica Fl400 for M530 / Ref. 10 744 764 / version 02

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 divisionMax-schmidheiny-strasse 201 cH-9435 HeerbruggPhone: +41 71 726 3333Fax: +41 71 726 3334

Legal disclaimerall 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.

LiabilityFor 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.

leica Fl400 for M530 / Ref. 10 744 764 / version 02 1

Contents1 Introduction 2

1.1 about this user manual 21.2 symbols in this user manual 21.3 optional product feactures 2

2 Product identification 2

3 Safety notes 33.1 intended use 33.2 contraindications 33.3 Personnel 33.4 dangers of use 33.5 signs and labels 3

4 Description 44.1 Function 44.2 design 44.3 controls 4

5 Preparation before surgery 65.1 calibration check 65.2 adjustments 65.3 Pre-operation checklist 11

6 Operation 126.1 Using the leica Fl400 for M530 126.2 controlling the Fl400 functions 12

7 Care and maintenance 12

8 What to do, if… 138.1 General 138.2 leica Fl400 for M530 13

9 Technical data 149.1 Technical data leica Fl400 for M530 149.2 compatibility 149.3 ambient conditions 14

10 Manufacturer's declaration of electromagnetic compatibility (EMC) 15

introduction

2 leica Fl400 for M530 / Ref. 10 744 764 / version 02

1 Introduction1.1 About this user manualThe leica Fl400 for M530 is an accessory for leica surgical microscope systems.in this user manual the functions of the leica Fl400 for M530 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")

XX Read this user manual carefully before operating the product.

1.2 Symbols in this user manualThe 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.

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.

XX action required; this symbol indicates that you need to perform a specific action or series of actions.

1.3 Optional product feacturesdifferent product features and accessories are optionally available. The availability varies from country to country and is subject to local regulatory requirements. Please contact your local representative for availability.

2 Product identificationThe model and serial numbers of your product are located on the identification label on the illumination unit. XX enter this data in your user manual and always refer to it when

you contact us or the service workshop regarding any questions you may have.

Type Serial no.

...

...

safety notes


3 Safety notesa leica surgical microscope with leica Fl400 for M530 is state-of-the-art technology. nevertheless, hazards can arise during operation. XX always follow the instructions in this user manual and in the

user manual of the leica surgical microscope, and in particular the safety notes.

3.1 Intended useThe leica Fl400 for M530 serves as a fluorescence excitation light system in conjunction with an approved tumor-selective substance (Gliolan = 5-ala = aminolaevulinic acid) for tissue characterization in open neurosurgery.

3.2 ContraindicationsThe medical contraindications applicable to the use of the leica Fl400 for M530 in combination with a fluorescence medium are those to be taken into account when using suitable brand substances.

WarNINg

Danger of injury to the eyes.XX do not use the leica Fl400 for M530 in ophthalmology.

3.3 Personnelonly trained personnel may operate the leica Fl400 for M530.

3.4 Dangers of use

NOTE

Mechanical interferenceTo ensure that the instrument did not suffer any mechanical interference since it was last used, a calibration check should be carried out prior to each new application. These can be provided by your iGs partner.

3.5 Signs and labelsType labelThe type label is located on the side of the leica Fl400 for M530 filter module.

description


4 Description4.1 FunctionThe illumination of the surgical microscope systems is a xenon lamp and is located in the stand. The leica Fl400 illumination filter module can provide visible and fluorescence excitation light.To switch between visible (white) and fluorescence mode illumination, a handle and/or footswitch button has to be defined in the user settings for each leica Fl400 user.

4.2 Designleica Fl400 for M530 is an accessory for the leica M530 surgical microscope.

4.2.1 Optics carrier with Leica FL400 for M530

22

3

1 1

1 leica optics carrier2 leica Fl800 UlT3 leica Fl400 for M530/leica Fl560 for M530

• optics carrier with integrated camera for visible light leica Hd c100 (optional)

• interface for assistants, either to the left and right side or to the back

• Main surgeon and back assistant interface, 360° rotatable both• Back assistant interface with fine focus knob• Fluorescence observation filter module (leica Fl400 for M530)• leica UlT system components built into the common housing of

the UlT

4.2.2 StandThe following is an example of a leica surgical microscope.

1

2

3 4

2

1

1 camera control unit2 documentation system control unit3 leica M530 oH6 surgical microscope4 leica M530 oHX surgical microscope

4.3 Controls4.3.1 Status-LEDs

status-leds are not available on all leica surgical microscopes.

1

Leica OH6 Leica OHX

2

on the swing arm the following leds are significant for the Fl400 application:1 status led for fluorescence

- led lights up in blue = Fl400 mode - led lights up in yellow = Fl800 mode - led lights up in green = Fl800 playback mode

2 status led for recording led lights up red = recording in progress

description


4.3.2 Handles

1

2

4

3

5

4

1

2

assignment in the factory setting1 Magnification2 4-function joystick3 Working distance4 Release all brakes5 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 "Fluorescence oncology FL400"

no function Y+

no function Y–

FL400modeon/o�

X–nofunction

X+

Selected brakesFL400 mode on/off

Working distance

Magni-fication

Magni-fication

Handle presets for "Fluorescence oncology FL400 & IgS DI C500"

IGS 3 Y+

IGS 1 Y–

IGS 4 X–IGS 2 X+


Working distance

Magni-fication

Magni-fication

Handle presets for "Fluorescence oncology FL400 & Vascular FL800"

FL800 NIR Zoom Reset Y+

Docu FL: Menu&Down Y–

FL800modeon/o�

X–

Docu FL:Playback&Enter

X+


Working distance

Magni-fication

Magni-fication

Preparation before surgery


5 Preparation before surgery5.1 Calibration check

NOTE

Mechanical interferenceTo ensure that the instrument did not suffer any mechanical interference since it was last used, a calibration check should be carried out prior to each new application. These can be provided by your iGs partner.

5.2 Adjustments 5.2.1 Adjustments on the control unit OH6 for

Leica FL400 functionsUsing the "Fluorescence Oncology FL400" user preset

The Fl400 user presets are only available if the Fl400 accessories are enabled in the accessory list in the service menu of your leica M530 oH6. if not, ask the leica service to do so.after selecting the user, the respective current mode is displayed on the right of the status line of the control unit and indicated by the leds on the swing arm.

XX in the Main menu click on the "Preset" button.

The available presets are displayed.

XX select the "Fluorescence oncology Fl400" user preset.XX click on the "select" button.

The selected user preset is displayed in the top line.either "White light" or "Fl400 Blue light" is displayed on the right side.



• as default, the working distance is limited in White light mode. if desired you can switch off the limitation in the User settings menu, see section 5.2.3

• in Fl400 mode limitation of working distance and magnification is always active.

Handle assignmentXX click on the "show settings" button.XX select the "Handle left" or "Handle Right" tab.

You see an overview with which buttons of the selected handle the Fl400 functions can be operated.

Modifying the "Fluorescence Oncology FL400" user preset

if you adjusted the settings of the "Fluorescence oncology Fl400" user preset to your needs during the application, you can adopt and save them under a new user name.

XX in the "User settings" menu click on "save" and then on "save as". XX select an empty position in the user list. XX enter the desired user name via the keyboard.XX 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 FL400 userXX click on the "Menu" quick access button and select

"User settings".

XX select "new User".XX open the "Handle left" or "Handle Right" tab to assign Fl400

functions to the handle.

XX in the left selection field, select the "Fluorescence" function group by clicking on it.XX assign the function "Fl400 Mode on/off" to any button by

selecting the desired function.XX 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.



XX Repeat this process for the other Fl400 functions.XX click "save".XX select an empty position in the user list. XX enter the desired user name via the keyboard, e.g. "5-ala User".XX click on the "save" button to save your settings under the user


BrightnessXX open the "Fl" tab to set the brightness in Fl400 mode to an

adequate level.

XX 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 Fl400 mode, the working distance will be reduced and the picture will get out of focus.



5.2.2 Adjustments on the Leica OHX control unit for Leica FL400 functions

Using the "Fluorescence Oncology FL400" user preset

The Fl400 user presets are only available if the Fl400 accessories are enabled in the accessory list in the service menu of your leica M530 oHX. if not, ask the leica service to do so.after selecting the user, the respective current mode is displayed on the right of the status line of the control unit and indicated by the leds on the swing arm.

XX in the Main menu click on the "Preset" button.The available presets are displayed.

select the "Fluorescence oncology Fl400" user preset.XX click on the "select" button.

The selected user preset is displayed in the top line.either "White light" or "Fl400 Blue light" is displayed on the right side.

• as default, the working distance is limited in White light mode. if desired you can switch off the limitation in the User settings menu, see section 5.3.3.

• in Fl400 mode limitation of working distance and magnification is always active.



Handle assignmentXX click on the "show settings" button.XX select the "Handle left" or "Handle Right" tab.

You see an overview with which buttons of the selected handle the Fl400 functions can be operated.

Modifying the "Fluorescence Oncology FL400" user preset

if you adjusted the settings of the "Fluorescence oncology Fl400" user preset to your needs during the application, you can adopt and save them under a new user name.

XX in the "User settings" menu click on "save" and then on "save as". XX select an empty position in the user list. XX enter the desired user name via the keyboard.XX click on the "save" button to save your settings under the user


These settings can later be edited at any time via the User settings menu.

Creating your own FL400 userXX click on the "Menu" quick access button and select

"User settings".

XX select "new User".XX open the "Handle left" or "Handle Right" tab to assign Fl400

functions to the handle.

XX in the left selection field, select the "Fluorescence" function group by clicking on it.XX assign the function "Fl400 Mode on/off" to any button by

selecting the desired function.



XX 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. XX Repeat this process for the other Fl400 functions.XX click "save".XX select an empty position in the user list. XX enter the desired user name via the keyboard, e.g. "5-ala User".XX click on the "save" button to save your settings under the user


BrightnessXX open the "Fl" tab to set the brightness in Fl400 mode to an

adequate level.

XX 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 Fl400 mode, the working distance will be reduced and the picture will get out of focus.

5.3 Pre-operation checklistCleaning optical accessories XX check optical accessories for cleanliness.

Balancing XX Balance the microscope in accordance with adding or removing

components (see the user manual of the particular surgical microscope).

Operational checkXX switch on the microscope.XX switch on the illumination.XX select an Fl400 user. XX check visually whether the microscope illumination has

switched from white to blue light.

SterilityXX attach the sterile drape and protection glass.


6 Operation6.1 Using the Leica FL400 for M530XX switch on the illumination of the particular surgical microscope.XX select either the "Fluorescence oncology Fl400" preset user or

your own Fl400 user.The status led on the swing arm of the particular surgical microscope is illuminated in blue if the Fl400 mode is active, and white if switched back to white-light mode.

if the illumination fails in the white-light or Fl400 mode, change to the second illumination source of the illumination unit.

6.2 Controlling the FL400 functionsno function Y+

no function Y–

FL400modeon/o�

X–nofunction

X+

XX if the Fl400 standard settings have been deleted, you can switch between white-light and Fl400 mode by pressing the joystick of the left leica M530 handle outward. if another control has been selected, Fl400 mode/white light is activated accordingly.

7 Care and maintenanceFor care and maintenance of the leica Fl400 for M530, please refer to the user manual of the particular surgical microscope.


8 What to do, if…if electrically operated functions do not work properly, always check these points first: • is the power switch switched on?• are the power cables attached correctly?• are all connecting cables attached correctly?• are all video cables attached correctly?

8.1 GeneralFor malfunctions regarding the leica stand and the leica M530 optics carrier refer to the user manual of the particular surgical microscope.

8.2 Leica FL400 for M530

Malfunction Cause remedy

no blue light in Fl400 mode

Fl400 mode not active

XX check that the fluorescence led and the control unit display the Fl400 mode.XX check whether the Fl400 on/oFF

function is assigned to a button of the handle.

Technical data


9 Technical data9.1 Technical data Leica FL400 for

M530FL400 characteristics

Fluorescence excitation 405 nm (blue light)

Fluorescence signal 635 nm (red)

FL400 spectrums

Leica M530 with built-in module Leica FL400 for M530

image sensor 1/2.8" cMos

integrated camera for visible light

leica Hd c100 built in (optional)

For other technical data refer to the user manual of the particular surgical microscope system.

Camera image size with respect to the field of view

integrated camera for visible light

Camera image size

Field of view

Field of view

The figure shows the camera image size with respect to the field of view for the visual video camera. Please be aware that the field of view is not fully covered by the documentation system.

9.2 Compatibilityleica surgical microscopes leica M530 oH6

leica M530 oHX

9.3 Ambient conditionsin use +10 °c to +40 °c

+50 °F to +104 °F 30 % to 95 % rel. humidity 800 mbar to 1060 mbar atmospheric pressure

storage –30 °c to +70 °c –86 °F to +158 °F 10 % to 100 % rel. humidity 500 mbar to 1060 mbar atmospheric pressure

Transport –30 °c to +70 °c –86 °F to +158 °F 10 % to 100 % rel. humidity 500 mbar to 1060 mbar atmospheric pressure

Manufacturer's declaration of electromagnetic compatibility (eMc)


10 Manufacturer's declaration of electromagnetic compatibility (EMC)

For the eMc declaration of the leica Fl400 for M530, please refer to the user manual of the particular leica surgical microscope system.

The fruitful collaboration ”with the user, for the user“ has always been the foundation of Leica Microsystems‘ innovative strength. On this basis, we have developed our five corporate values: Pioneering, High-end Quality, Team Spirit, Dedication to Science, and Continuous Improvement.

MeDICaL DIvISIOnWhat does a surgeon expect from an outstanding surgical microscope?Sharp, clear images, and a modular system aligned with the surgeon and OR staff needs.

Innovations for your practiceFrom the first surgical microscope with widefield optics in the 1980s to the first microscopes with Horizontal Optics and with LeD illumination, Leica Microsystems has been at the forefront of innovation in the development of surgical microscopes.

HD video, fluorescence and retinal viewing systems also demonstrate the continued innovative nature of the Leica team. We strive to provide the surgeon with leading edge technology to enhance performance, surgeon comfort, and patient outcomes.

The Medical Division, within Leica Microsystems (Schweiz) aG, holds the management system certificates for the international standards ISO 9001, ISO 13485, and ISO 14001 relating to quality management, quality assurance and environmental management.

Leica Microsystems – an international company with a strong network of worldwide customer services:

Active worldwide Tel. FaxUSA ∙ Buffalo Grove/Illinois +1 800 248 0123 +1 847 405 0164 Canada ∙ Concord/Ontario +1 800 248 0123 +1 847 405 0164

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www.leica-microsystems.com

10 744 764en/02 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2014 • Printed – X.2014 – Editing for printout by galledia •

Subject to modifications. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH.

leica fl400 for m530 fl400/user... · 2021. 5. 17. · leica fl400 for m530 / ref. 10 744 764 /...

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