M525 OH4 User Manual Ver 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

Leica M525 OH4 / Ref. 10 714 367 / Version 00

Chapter overview

Introduction

3

Controls

4

Preparation Before Surgery

17

Use

35

Accessories

53

Safety Notes

57

Care and Maintenance

67

Disposal

72

What To Do If...?

73

Specifications

77

Leica M525 OH4 / Ref. 10 714 367 / Version 00

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Contents Page

Page Introduction User manual Product identification Symbols in this user manual Controls Design Leica M525 microscope with swing arm Control unit Terminals Stand CAN handles Footswitch Mouth switch Preparation Before Surgery Checklist: Before the operation Installing optical accessories Mounting beam splitter, rotatable Setting the tube Adjusting the eyepiece Installing documentation accessories Selecting documentation accessories Stand settings Changing the weight disk on the D-axis Releasing the brakes Transport, transporting and rest positions Positioning on the operating table Attaching sterile controls Operation Positioning the microscope Adjusting the microscope Control unit with touch panel Leica DI C500 XGA Assignment The Maintenance menu The "How to..." menu The Service menu Shutting down the surgical microscope Accessories Beam splitter Beam splitter with counterweight 180° dual stereo attachment Ultra Observer Leica ULT500 Beam splitter, rotatable, 50/50 % Dual Imaging Color Module Leica DI C500 WD Extender Stereo attachment for second observer Tubes Accessories list for advanced configurations Video and photo accessories for Leica M525

2

3 3 3 4 6 7 7 8 9 9 9 17 18 19 19 20 20 22 23 30 31 32 33 33 35 35 41 48 50 51 52 52 52

Safety Notes Intended use of the instrument Information for the person responsible for the instrument Directions for the operator of the instrument Dangers of use Manufacturer's declaration of electromagnetic compatibility (EMC) Signs and labels Care and Maintenance Maintenance instructions Cleaning the touch panel Maintenance Changing bulbs Checking the timer for the xenon lamp Changing fuses Notes on reprocessing of resterilizable products Instructions Disposal Disposal What To Do If...? General faults TV, photography Error messages on the control unit Specifications Electrical data Leica M525 Accessories IGS Fluorescence Floor stand Ambient conditions Standards fulfilled Limitations of use List of weights of balanceable configurations Dimensional drawings

53 53 53 53 53 54 54 54 54 55 56

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General Instructions

User manual

Symbols in this user manual

This user manual contains important safety notes as well as information on using the instrument (see the chapter "Safety Notes").

Before setting up the product, carefully read through the user manual.

Product identification The model and serial numbers of your product are located on the identification label on the illumination unit. 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.:

The symbols used in this User Manual have the following 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 and/or 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.

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Controls

Design Leica M525 OH4 surgical microscope

    

 



1 2 3 4 5 6 7 8

4

Swing arm Tension rod Video monitor (optional) Control unit with touch panel Suspension device for footswitch Illumination unit Base Leica M525 optics carrier

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Controls

  

1 2 3 4 5 6 7

Vertical arm Terminals Footbrake Handle Articulated arm for monitor Camera control unit (optional) Leica MDRS system unit (optional) The Leica M525, with its open architecture, provides space for holding the video control unit and the Leica MDRS.

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Controls

Leica M525 microscope with swing arm  



15 CAN socket for accessories (DI C500, FL400) 16 CAN socket (not used) 17 Optical fiber

 

   

1 Status LED for fluorescence - LED illuminates in white = white light mode - LED illuminates in blue = blue light mode - LED illuminates in yellow = NIR mode - LED illuminates in green = playback mode 2 Status LED for recording LED lights up red = recording in progress 3 Push-button for intraoperative AC/BC balancing 4 Switch for manual balancing of the C-carriage 5 C sledge 6 CAN handle 7 Display of set working distance 8 M525 optics carrier 9 Switch for manual balancing of the A sledge 10 A sledge 11 CAN handle clamping lever 12 Switch for manual balancing of the B sledge 13 B sledge 14 Microscope carrier

  

 

18 Rotary knob for zoom adjustment 19 Rotary knob for field diameter adjustment 20 Reset button for zoom-dependent field diameter adjustment 21 Status LED, multifocal focus 22 Multifocal focus key 23 Rotary knob for focus adjustment 24 Working distance display Notes on the wiring are found in the "System Sheets" provided and in the Installation Manual provided.

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Controls

Control unit 

    





1 Touch panel 2 Push-button with illumination LED (on/off) 3 Push-button with LED for Auto Balance

Terminals 









11 only for Storz light source 12 UV camera, Hitachi 13 BNC IN (2×) 14 BNC OUT 15 S-video IN (2×) 16 S-Video OUT 17 only for Storz footswitch

4 AD.F. Additional Function 2 5 AD.F. Additional Function 1 6 Foot/handswitch 2 * 7 Foot/handswitch 1 * 8 Internal CAN ** 9 External CAN *** 10 External CAN ***

18 only for Sony 12 V NIR camera 19 only for DOCU Leica MDRS (HDMD®) 20 SVGA IN 3 21 SVGA IN 2 22 SVGA IN 1 23 SVGA OUT to Leica DI C500

AD.F. 1 and 2 are digital relay outputs that can switch 24 V/2 A. Only foot and handswitches supplied by Leica Microsystems (Schweiz) AG may be connected to the foot/ handswitch 1 and 2 (6) and (7) terminals. **) Only a Leica Autofocus may be connected here. ***) Only systems verified by Leica Microsystems (Schweiz) AG may be connected here. *)

24 S-Video adapter 25 BNC adapter 26 Ethernet adapter Connections 24, 25 and 26 are couplings for guiding connections of the optional Leica MDRS system unit or a camera control unit towards the outside.

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Controls

Stand



 



  

9 Lamp inserts for main illumination or backup illumination 10 Lever for switching to standby illumination The Leica M525 OH4 surgical microscope has a primary illumination source and an equivalent standby illumination source.

 1 2 3 4 5 6 7

Illumination unit Access door Screw knob Master switch for Leica M525 OH4 surgical microscope Selector switch 100 V/120 V/220 V/240 V Power supply Equipotential bonding socket For connecting the Leica M525 OH4 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). 8 Fuse box flap

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Controls

Mouth switch

CAN handles 

  

6 Release "XYZ Free" brakes 1 2 3 4 5

Zoom 4-function joystick Focus Release all brakes Release preselected brakes You can assign switches 1, 2, 3 and 5 of the CAN handles individually for each user in the configuration menu (see pages 46 and 47).

Footswitch This is an overview of all possible footswitches you can use to control your Leica M525 surgical microscope. Footswitches can be assigned individually for each user in the configuration menu (see pages 45 and 46). Footswitch 12 functions crosswise

Footswitch 16 functions crosswise

Footswitch 12 functions lengthwise

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Footswitch 16 functions lengthwise

9

Controls

"Cranial"/"Spinal"/"ENT" presets Here you will find an overview of the assignments of the CAN handles and an optionally connected footswitch for the users of the "Cranial"/"Spinal"/"ENT" presets. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

Y+

Y+

X–

X+

X–

X+

Zoom +

Y–

Y–

Zoom +

Zoom –

Focus +

Focus +

Zoom –

Focus –

Focus –

All Brakes

All Brakes

Selected Brakes

Selected Brakes

Y+ X+

X– Focus +

Focus –

No Function

No Function

No Function

No Function

Zoom +

Zoom – Y–

10

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Controls "Image Injection IGS DI C500" preset Here you will find an overview of the assignments of the CAN handles and an optionally connected footswitch for the user of the "Image Injection IGS DI C500" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

IGS 3

Y+

IGS 1

IGS 2

X–

Zoom +

IGS 4

Y–

Zoom –

Focus +

Focus +

Focus –

Focus –

All Brakes

All Brakes

XGA Output Toggle

X+ Zoom + Zoom –

Selected Brakes

Y+ X–

X+

Focus +

Focus –

IGS 3

IGS 1

IGS 2

IGS 4

Zoom +

Zoom – Y–

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Controls "Image Injection ENDO DI C500" preset Here you will find an overview of the assignments of the CAN handles and an optionally connected footswitch for the user of the "Image Injection ENDO DI C500" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

No Function

Y+ DIC: Shutter Control

DIC: Image On/Off

No Function

Zoom + Zoom –

X–

X+

Y–

Zoom +

Focus +

Focus +

Focus –

Focus –

All Brakes

All Brakes

Selected Brakes

Selected Brakes

Y+ X–

X+

Focus +

Focus –

DIC: Image On/Off

DIC: Shutter Control

No Function

No Function

Zoom +

Zoom – Y–

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Zoom –

Controls "Fluorescence Vascular FL800" preset This gives an overview of the CAN handles and an optional connected footswitch for the user of the "Fluorescence Vascular FL800" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

FL800 NIR Zoom Reset

Y+

FL800 Mode On/Off

MDRS FL: Playback

X–

Zoom +

MDRS FL: Step Loop

Y–

Zoom –

Focus +

Focus +

Focus –

Focus –

All Brakes

All Brakes

Selected Brakes

X+ Zoom + Zoom –

Selected Brakes

Y+ X–

X+

Focus +

Focus –

FL800 Mode On/Off

FL800 NIR Zoom Reset

MDRS FL: Step Loop

MDRS FL: Playback

Zoom +

Zoom –

Y–

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Controls "Fluorescence Oncology FL400" preset This gives an overview of the CAN handles and an optional connected footswitch for the user of the "Fluorescence oncology FL400" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

No Function

Y+

FL400 Mode On/Off

No Function

X–

Zoom +

No Function

Y–

Zoom –

Focus +

Focus +

Focus –

Focus –

All Brakes

All Brakes

Selected Brakes

Selected Brakes

Y+ X+

X– Focus +

Focus –

FL400 Mode On/Off

No Function

No Function

No Function Zoom –

Zoom + Y–

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Leica M525 OH4 / Ref. 10 714 367 / Version 00

X+ Zoom + Zoom –

Controls "Fluorescence Oncology FL400 & IGS DI C500" preset This gives an overview of the CAN handles and an optional connected footswitch for the user of the "Fluorescence oncology FL400 & DI C500" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

IGS 3

Y+

IGS 1

IGS 2

X–

Zoom +

IGS 4

Y–

Zoom –

Focus +

Focus +

Focus –

Focus –

All Brakes

All Brakes

FL400 Mode On/Off

X+ Zoom + Zoom –

Selected Brakes

IGS 3 IGS 1

IGS 2

Focus +

Focus –

FL400 Mode On/Off

No Function

No Function

No Function

Zoom +

Zoom – IGS 4

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Controls "Fluorescence Oncology FL400 & Vascular FL800" preset This gives an overview of the CAN handles and an optional connected footswitch for the user "Fluorescence Oncology FL400 & Vascular" preset. CAN handles and footswitches can be assigned individually for each user in the configuration menu (see pages 45 to 47).

FL800 NIR Zoom Reset

Y+

FL800 Mode On/Off

MDRS FL: Playback

Zoom +

MDRS FL: Step Loop Focus +

Zoom –

X– Y– Focus +

Focus –

Focus –

All Brakes

All Brakes

FL400 Mode On/Off

Selected Brakes

FL800 NIR Zoom Reset FL400 Mode On/Off

MDRS FL: Playback

Focus +

Focus –

FL400 Mode On/Off

No Function

No Function

No Function Zoom –

Zoom + MDRS FL: Step Loop

16

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X+ Zoom + Zoom –

Preparation Before Surgery

Checklist: Before the operation Cleaning the optical accessories Check the tubes, eyepieces and the documentation accessories (if used) for cleanliness. Remove dust and dirt (see page 67). Installing the accessories Lock the Leica M525 OH4 in place and install all accessories on the microscope so it is ready for use (see page 18). Position the CAN handles as desired. Connect the mouthswitch and/or footswitch, if used. Check the camera image on the monitor and realign if necessary.

Function check Warning 1 Danger of fatal electrical shock! The Leica M525 OH4 surgical microscope may be connected to a grounded socket only. Connect the power cable. Switch on the microscope. Switch on the illuminator at the control unit. Leave the illumination on for at least 5 minutes, as otherwise luminosity will decrease rapidly. Replace defective bulbs before the operation begins. Test all functions on the CAN handles and the footswitch. Check the user settings on the control unit for the selected user (see page 42).

Checking the tube settings Check the tube and eyepiece setting for the selected user (see pages 19 and 20). Treat the eyepieces with an antifogging compound if necessary.

Positioning at the OP table Position the surgical microscope on the OP table as required, and lock the footbrake (see page 32).

Balancing Balance the Leica M525 OH4 (see pages 23-25). Press the "All Brakes" button on the CAN handle and check the balancing.

Sterility Fit sterile components and sterile drape if used (see pages 33 and 34). Warning 2 Danger of fatal electric shock. Operate the system only with all equipment in its proper position (all covers fitted, doors closed).

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Preparation Before Surgery

Installing optical accessories

Installing the 90° stereo attachment, binocular tube and beam splitter

Warning 3 Risk of injury from downward movement of surgical microscope! Complete all preparations and adjustments to the stand before the operation. Never change the accessories or attempt to rebalance the microscope while it is above the field of operation. Before changing accessories, always lock the Leica M525 OH4. After changing accessories, always balance the Leica M525 OH4. Do not release the brakes when the instrument is in an unbalanced state. Locking the Leica M525 OH4 in position

The D-axis of the Leica M525 OH4 is locked in position with the locking device. The locking device is principally for installation and re-equipping the Leica M525 OH4. Pull out the locking knobs (1 and 2) and rotate them until the two points (arrows) are positioned one above the other.

Release the clamping screw (3). Insert the accessories into the dovetail ring from above. Tighten the clamping screw (3). Installing the stereo attachment for second observer

Insert the stereo attachment and check whether the connection has engaged. Tighten the locknut (4) by hand. Align the attachment for second observer as required.

Move the swing arm up and down until the locking device (1) engages. Move the swing arm forwards and back until the locking mechanism (2) engages. 18

Leica M525 OH4 / Ref. 10 714 367 / Version 00