FL800 for M720 OH5, M525 OH4 and M525 F50 User Manual and Installations Instructions Ver 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

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Chapter overview

Introduction

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Leica M720 OH5 FL800

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Controls

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Assembly

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Preparation before the operation

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Use

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Leica M525 OH4 FL800

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Controls

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Assembly

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Preparation before the operation

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Use

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Leica M525 F50 FL800

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Controls

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Assembly

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Preparation before the operation

57

Use

59

General instructions

67

Safety notes

68

Care and maintenance

79

What to do if...?

82

Technical data

83

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Contents Introduction User manual Product identification Symbols used in this manual

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Leica M720 OH5 FL800 Controls Connections on the Leica OH5 with FL800 Leica FL800 components Leica NIR dual video adapter Leica CAN handle (left) Leica MDRS system unit (optional) Assembly Leica FL800 assembly Attaching the Leica NIR dual video adapter and NIR Sony camera Camera Setting Connecting the Leica FL800 components Installing and connecting the fluorescence components Adjustments in the control unit for FL800 Settings in the Leica MDRS for use with Leica FL800 Focussing and calibration of the NIR-data overlay Preparation before the operation Pre-operation checklist (FL800) Checking the Leica FL800 illumination Use Using the Leica FL800 Controlling the FL800 functions Data display in an optional Leica DI C700

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Leica M525 OH4 FL800 Controls Connections on the Leica OH4 with FL800 Leica FL800 components Leica NIR dual video adapter Leica CAN handle (left) Leica MDRS system unit (optional) Assembly Leica FL800 assembly Attaching the Leica NIR dual video adapter and NIR Sony camera Camera Setting Connecting the Leica FL800 components Installing and connecting the fluorescence components Adjustments in the control unit for FL800 Settings in the Leica MDRS for use with Leica FL800 Focussing and calibration of the NIR-data overlay

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Preparation before the operation Pre-operation checklist (FL800) Checking the Leica FL800 illumination Setting up the optional Leica DI C500 Use Using the Leica FL800 Controlling the FL800 functions Data display in an optional Leica DI C500

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Leica M525 F50 FL800 Controls Connections on the Leica F50 with FL800 Leica FL800 components Leica NIR dual video adapter Leica CAN handle (left) Leica MDRS system unit (optional) Assembly Leica FL800 assembly Attaching the Leica NIR dual video adapter and NIR Sony camera Camera Setting Connecting the Leica FL800 components Adjustments in the control unit for FL800 Settings in the Leica MDRS for use with Leica FL800 Focussing and calibration of the NIR-data overlay Preparation before the operation Pre-operation checklist (FL800) Checking the Leica FL800 illumination Setting up the optional Leica DI C500 Use Using the Leica FL800 Controlling the FL800 functions Data display in an optional Leica DI C500 Cabeling of the Leica FL800

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General instructions Safety notes Intended use of instrument Prohibited uses Information for the person responsible for the instrument User qualifications Directions for the operator of the instrument Dangers of use Manufacturer’s declaration of electromagnetic compatibility (EMC) Signs and labels

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Contents Care and maintenance Maintenance instructions Maintenance Notes on reprocessing of resterilizable products Instructions Table: Sterilization What to do, if... General Leica FL800 Leica MDRS fluorescence software Technical data Leica FL800 Electrical data Ambient conditions Standards Limitations of use Weight list, balanceable configurations Leica M720 OH5 FL800 Weight list, balanceable configurations Leica M525 OH4 FL800 Weight list, balanceable configurations Leica M525 F50 FL800

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Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Introduction

User manual

Symbols used in this manual The symbols used in this manual have the following meaning:

In addition to instructions for use, this user m ­ anual also provides important safety notes (see the chapter entitled, „Safety notes“). Read this user manual carefully before operating the product.

Warning Warning against dangers of use or improper use that could result in serious personal injuries or death. Caution Warning against dangers of use or improper use that could result in minor personal injuries only, but could cause significant damages to property, fixed assets or the environment.

Product identification The model code and serial number of your product are provided on the nameplate found on the illumination unit. Transfer this information to your manual and always refer to it when contacting our representative or service workshop with questions. Model:       Serial No.:

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Information about use that helps the user to employ the product technically correct and efficiently. é

Request for action; here, you are requested to take action.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Leica M720 OH5 FL800

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Leica M70 OH5 FL800

Leica M720 OH5 FL800 Leica M720 OH5 with Leica FL800

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Leica M720 optics carrier with Leica FL800 CAN handles Leica OH5 illumination unit Hinged arm monitor MDRS 19“ touchscreen monitor (optional) MDRS system unit (optional)

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Leica M70 OH5 FL800 Leica M720 optics carrier with Leica FL800

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7 White-light camera 8 M720 optics carrier 9 FL800 NIR Sony XC-EI 50 camera 10 Leica NIR Dual Video Adapter 11 Status LED for fluorescence LED lights up in... White = achromatic light mode Blue = Blue light mode (if an optional Leica FL400 is built into the system) Yellow = NIR mode Green = playback mode (MDRS) 12 Status LED for MDRS recording LED lights up in... Red = recording is on Brief flashing „Red“ = single-image recording 13 Leica DI C700 (optional)

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Controls

Connections on the Leica OH5 with FL800

MDRS

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Leica NIR dual video adapter

Storz LightSource FL400 Camera Hitachi Video IN (NIR-Cam) Video IN (FL400-Cam) Video OUT MDRS

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S-Video IN

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S-Video IN

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S-Video OUT

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IN XGA 3

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IN XGA 2

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IN XGA 1

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OUT XGA DIC500

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Leica FL800 components

Storz FootSwitch 12V NIRCamera SONY

XGA Switchboard

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FL Connectorboard

13 Video input for NIR Sony camera 14 Video input for Microscope camera 15 Video output to MDRS or OR monitor 16 S-video input for NIR Sony camera 17 S-video input for Microscope camera 18 S-video output to MDRS or OR monitor

25 Connection Beam splitter 26 Connection for C mount white-light camera 27 Connection with focus for C mount NIR camera 27a Lockable adjusting ring for NIR-focussing 27b Set screw for singular device adjustment 27c Set screw for often used adjustment 61 Y-CAN cable Leica CAN handle (left)

30 Use either only BNC (13 to 15) or S-Video (16 to 18) connections. S-video signals offer a higher quality! 19 12-V NIR Sony camera 20 XGA out to Leica DI C700 21 XGA input 1 22 XGA input 2 23 XGA input 3 24 MDRS control system

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28 Joystick for controlling the FL800 functions 29 Focus 30 Zoom 31 „All-free“ button (all brakes) 32 Selector button (3 brakes for „XYZ Free“ or „Focus Lock“)

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Controls Leica MDRS system unit (optional) 33

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LEICA MDRS4

Front plate 33 CD/DVD drive 34 2x USB connection (e.g. for USB memory stick, optional touchpad) 35 ON/OFF switch

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Rear plate 36 MDRS footswitch (optional) 37 DVI output for monitor* 38 S-video input 39 3x BNC input 40 19-V system supply 41 Audio cable 42 Touch control USB 43 XGA output (for additional monitor or DI C700)* 44 Control cable OH5 45 S-video or BNC output, e.g. for OR monitor* 46 Keyboard (optional) *Only two of three outputs (37/43/45) can be used at the same time.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Assembly

Leica FL800 assembly Warning 1 Danger of injury to the patient é Do not install or remove Leica FL800 accessories above the patient. é After every refitting, rebalance the Leica M720 OH5 FL800. Attaching the Leica NIR dual video adapter and NIR Sony camera 27 Video / Assistant output of the Leica M720 9 Sony FL800 NIR camera 26 (White-light) Microscope camera 10 Leica NIR Dual Video Adapter

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27

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Both cameras connected to the NIR dual video adapter must have the same chip size e.g. 1/3“ NIR and 1/3“ White-light or 1/2“ NIR and 1/2“ White-light! (see also the chapter Technical Data on page 83)

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é Dual Video Adapter for simultaneously connecting a C-mount microscope camera and the FL800 Sony NIR camera with C-mount port é The Leica NIR Dual Video Adapter is installed on the documentation output. é The Dual Video Adapter offers a motorized fine-focussing for the visible and near infrared light and additionnally a manual NIR fine-adjustment.

é Insert the Dual Video Adapter into the documentation output of the Leica M720, engage it and fasten it in place. é Screw cameras onto the C-mount adapter, guide the camera into the right position (determine horizon through the binoculars) and tighten the clamping screw. é Connect the CAN-cable of the Dual Video Adapter to the Lemo plug under the cover of the AB sledge. If the CAN bus interface is already occupied, connect (plug) in-between the enclosed Y-CAN cable. é Plug in the handswitch on the control unit at the internal CAN bus interface.

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Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Assembly é Screw FL800 NIR Sony camera (9) on the top (27) camera connection. Adjust the orientation of the white-light camera. The top of the view in the microscope eyepiece must also be at the top of the monitor image.

é Plug in the handswitch for the motorized fine focus function on the control unit of the OH5 (internal CAN bus-interface). Use the NIR test pattern to check the orientation and the NIR-image. (Also see „Checking the Leica FL800 illumination“ on page 17) é Move the NIR test pattern away from you (toward 12 o’clock position) into the center of the image. é Observe the camera image on the monitor. The camera image moves upward é camera orientation OK downward é turn camera 180° to right é turn camera 90° to left to left é turn camera 90° to right Please ensure that the bottom DIP switch on the Sony NIR camera head is set to the right.

Camera Setting

Adjusting the parfocality of the Leica Dual Video Adapter é Set the M720 to maximum magnification. é Place a flat test specimen with sharp contours under the objective. é Look through the eyepieces and focus the microscope. é Set the Leica M720 to minimum magnification. é Bring the monitor image into focus on the Leica Dual Video Adapter.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Assembly Connecting the Leica FL800 components 58 46

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FL Connectorboard

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active S-video splitter

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Active S-video splitter Standard S-video video cable FL800 NIR Sony camera Optional DI C700 MDRS touchscreen (optional) Audio cable Leica DI C700 XGA cable MDRS control cable (optional)

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BNC to S-video adapter Standard BNC video cable Microscope camera (control unit and camera head) MDRS system unit (optional) Optional OR monitor Cable for USB touch control (optional) Y-cable FL800 NIR Sony camera DVI monitor cable (optional)

Use either only composite or only S-video signals for your installation. S-video signals feature a better quality than composite signals. If you are using S-video signals, connect the Y-cable of the FL800 NIR Sony camera with the BNC to S-video adapter to the FL connector board. Use the active video splitter if you also want to display the video image on an optional OR monitor in addition to the internal MDRS recording system. An optional OR monitor can be connected with the OH5 using the video couplings. An overview of all components connected to your system has been provided in your delivery documentation by your Leica representative. 12

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Assembly

Installing and connecting the fluorescence components

Overview of filter positions (front view)

Installing Leica FL800 fluorescence filters B

é Loosen the two Phillips screws (1) and remove the cover (2). A

2

C

D

1

Fig. 3 A B C D

empty standard filter (31.3 mm) FL400 filter (optional) FL800 filter (32.0 mm)

Fig. 1

é Loosen the two Phillips screws and remove the filter holder and aperture.

é Use a 2.5 mm Allen key to loosen the grub screw (3) retaining the filter wheel (4).

é Insert the appropriate filters and secure them by replacing the filter holder and two Phillips screws.

é Slide the filter wheel (4) from its axis. Vorne / Front

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4

Filterhalter / Filter holder Blende / Blind

Fig. 4 Fig. 2

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Assembly Adjustments in the control unit for FL800 Ensure that the FL800 accessories are enabled in the accessory list in the service menu of your OH5. Afterwards, the respective current mode is displayed on the right of the status line of the control unit and indicated by the LEDs on the swinging arm. Use the „Fluorescence Vascular FL800“ user preset

é Click on the „Show Settings“ button. é Select the „Handle Left“ tab.

é Click on the „Preset“ button.

é You see an overview with which buttons of the left handle the FL800 functions can be operated. If you adjusted the settings of the „Fluorescence Vascular FL800“ user preset do your needs during the application, you can adopt and save them under a new user name. é Select the „Fluorescence Vascular FL800“ user preset. é Click on the „Select“ button.

é Click on „Save“ and then on „Save as“. é Select an empty position in the user list. é Enter the desired user name via the keyboard. é 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.

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Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Assembly Configuring your own FL800 user é Click on the „Menu“ quick access button. é Under user template, you can create your own FL800 user.

In the service menu, you can adjust a value for the maximum duration of the FL800 mode from 10 to 180 seconds. Adjustments in the control unit for an optionally connected Leica DI C700 In the User Settings menu, adjust the settings for the Leica DI C700 for an FL800 user as follows, e.g. when looking at the ICG-NIR image in the left eyepiece. é Open the „DI C700“ tab.

é Select „New User“. é Open the „Handle Left“ or „Handle Right“ tab to assign FL800 functions to the handle.

é In the left selection window, select the „Fluorescence“ function group by clicking on it. é Assign the function „FL800 Mode On/Off“ to any button by selecting the desired function. é Afterwards, click on the label field of the desired button to assign the desired function. Or é Press the desired button on the handle to be assigned. é Repeat this process for the functions „ FL800 NIR Zoom Reset“, „MDRS FL Playback“ and „MDRS FL Step Loop“. é Click on „Save“. é Select an empty position in the user list. é Enter the desired user name via the keyboard, e.g. „ICG User“. é Click on the „Save“ button to save your settings under the user name entered at the desired location.

é Select the „Non-Overlay (closed)“ setting as the „Manual Shutter Settings“. é The „Display Shutter Settings (Non-Overlay Data)“ setting allows you to define whether you want to see during the playback of the ICG-NIR sequences in both eyepieces (here also right) the ICG-NIR image. Choose „Display-Shutter Non-Overlay Data“ = open. é If not asked differently by the user, choose „Display-Shutter Non-Overlay Data“ = closed. This means, you can have the original image in one eyepiece and the NIR-information in the other one at the same time, allowing you to merge cognitively both information.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Assembly In combination with the Leica MDRS with fluorescence software, the Leica DI C700 can be used for the ­correctly scaled display of the FL800 video signal for the anatomy visible in the microscope.

Settings in the Leica MDRS for use with Leica FL800 For the activation of the LEICA FL800 at the LEICA MDRS (SW 4.7 and higher) press Ctrl + Alt + F3. This will reboot the LEICA MDRS. After that you will be asked to enter two Activation Keys:

➞

Focussing and calibration of the NIR-data overlay é The file „medxrecorderv4.ini“ in „my ComputerC:MedXStream“ has got 4 parameters to define the size and position of the injected NIT-image. é Change the parameters to match the injected image with the object. é The ICG-settings are the last in the parameters’ list, but a separate group of parameters in the file „medxrecorderv4.ini“.

Top

Picture 1: Main Activation Key

Left

➞

Height Width

Picture 2: Leica FL800 Activation Key The two activation codes you will get from: MedXchange Office number: 9 am to 5 pm EST USA +1 941 794 9977 Cell numbers: Chris Samano +1 941 538 2732 Corey Park +1 941 524 4041 Mike Wise +1 941 704 4030 Email: leica@medxchange.com

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… Facility=0 [ICG] Top=205 Left=155 Width=500 Height=376 [Ports] … é Use the new ICG-standard sample with the two ICG-objects for the correct setup. é The long distance between both objects allows a very ­precise setting of all parameters. é Focus on the standard sample in white-light mode and magnify until the standard sample matches the image size on the video monitor. é Change to the ICG-mode. Observe the fluorescence signal and adjust the separate NIR-fine focus of the Dual Video Adapter at the chosen magnification. Fix the alignment with the enclosed adjustment screws.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

Assembly a) for a general setting (recommended) use the set screw 27b and tighten it carefully with the appropriate devise (prevents involuntary loosening and therewith maladjustment). b) for a variable setting during or in-between surgeries use set screw 27c (allows optimal focussing even using extreme magnification settings).

low intensity

Example: The size of the NIR-image (light-colored objects) has to be reduced. The position should be lower and further left in the ocular. To match the white-light image of the standard sample (gray objects) reduce proportionally the height and width, then augment the „Top“ and reduce the „Left“.

é Should the fluorescence signal be too intensive, use the back side of the standard sample. This back side produces a less intense luminosity signal with a contrast pattern (cross and star). This way you can easily focus on the NIR-image. é Run the MDRS-recording program and start the calibration process. Use the following example to make the correct ­settings. é Open the Leica DI C700 „main shutter“ to overlay the NIRimage and the white-light image (Service setting only for this calibration). Refer to the user manual Leica M720 OH5.

Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01

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Assembly

é This calibration needs to be done once for each installation or Demo-setup.

… Facility=0 [ICG] Top=205 Left=155 Width=500 Height=376 [Ports] … Change: „Top“ ca. „230“=lower „Left“ ca. „130“=further left „Width“ ca. „400“=smaller „Height“ ca. „300“=smaller é Save the .ini-file and check the settings by closing the MDRSrecording program and restarting it. é The calibration was successful if both fluorescence objects overlay the injected fluorescence information injected into the Leica DI C700.

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Leica FL800 for Leica M720 OH5, Leica M525 OH4 and Leica M525 F50 / Ref. 10 716 079 / Version 01