Leica M320 User Manual
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Leica M320 User Manual

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From Eye to Insight
M320
User Manual
10734261 - Version 02

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Summary of Contents for Leica M320

  • Page 1 From Eye to Insight M320 User Manual 10734261 - Version 02...
  • Page 2 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.

  • Page 3: Table Of Contents

    13.10 Compliance IEC 60601-1-2 7.14 Installing the drape 13.11 Standards fulfilled 7.15 Balancing the swing arm 13.12 Limitations on use 7.16 Adjusting the interpupillary distance 13.13 Working range 7.17 Checking the illumination 13.14 Dimensions F12 (in mm) M320 Ref. 10734261 / Version 02...

  • Page 4: Introduction

    The symbols used in this user manual have the following meaning: About this user manual Symbol Warning Meaning In this user manual the surgical microscope M320 is described. The word present user manual applies to the M320 with the following Warning Indicates a potentially hazardous situation stand variants: F12, C12, W12, FP12, TC12, LW12 and TP12.

  • Page 5: Product Identification

    The model and serial numbers of your product are located on the identification label at the bottom of the horizontal arm. 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. M320 Ref. 10734261 / Version 02...

  • Page 6: Safety Notes

    Other accessories, provided that these have been expressly • The Leica M320 surgical microscope may only be used in closed approved by Leica as being technically safe in the context. rooms and must be placed on a solid floor or mounted to the Use original accessories or approved Leica accessories only.

  • Page 7: User Qualifications

    Follow the instructions given by your employer regarding the no closer than 30 cm (12 inches) to any part of the Leica M320, organization of work and safety at work. including cables specified by the manufacturer. Otherwise, Do not modify the surgical microscope.

  • Page 8: Dangers Of Use

    • Abrupt braking of the surgical microscope at a threshold that cannot be crossed. For transportation, always move the Leica M320 surgical microscope into the transport position. Never move the stand while the unit is extended. Never roll the stand or OP equipment over the cables lying on the floor.

  • Page 9: Signs And Labels

    Signs and labels Signs and labels 1, 8 2, 4, 5, 7, 11, 14, 6 9,10 14, 6 M320 Ref. 10734261 / Version 02...
  • Page 10 Max. load for optics carrier Type label Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL LEICA M320 LW12/ TP12/ TC12/ F12 100 V - 240 V 50 - 60 Hz 100 VA 2x T6.3 AH 250 V Leica Microsystems (Schweiz) AG...
  • Page 11 Prefix number Leica system article no. Serial number Incremental number starting at 1 for each batch J = year (2 digits) MM = month (2 digits) TT = day (2 digits) Production starting date M320 Ref. 10734261 / Version 02...

  • Page 12: Design

    Wall stand (LW12) Rolling floor stand (F12), long swing arm Reference model in current user manual Table stand with plate (TP12) Rolling floor stand, short swing Wall stand (W12) Ceiling mount (C12) Floor stand/baseplate (FP12) M320 Ref. 10734261 / Version 02...

  • Page 13: Swing Arm And Horizontal Arm

    The integrated tilt switch is not available for models TC12, TP12 and LW12. Filter and diaphragm controls for white light, orange filter and spot illumination. Counterweight for balancing when many accessories are used. M320 Ref. 10734261 / Version 02...

  • Page 14: Microscope Carrier

    Articulation brake Two different versions are available. Inclined Lever for locking the vertical position. Upright Joint for balancing Upright installation is not possible for models TC12, TP12 and LW12 Articulation brake Articulation brake Tilt brake M320 Ref. 10734261 / Version 02...

  • Page 15: Connections

    Design Connections Rotary brake (inclined version) Brake knob for setting the articulation brakes Articulation brake (LW12, TP12, TC12) Main switch Power socket Port for HDMI/USB cable M320 Ref. 10734261 / Version 02...

  • Page 16: Functions

    Functions Functions Balancing system With a balanced surgical microscope Leica M320 F12 you can move Illumination the optics in any position without it tilting or falling. The illumination of the surgical microscope M320 consists of 2 LEDs. Remove the screw.

  • Page 17: Footbrakes

    The wheel is engaged and released with the footbrake engage/release lever (1). Press the footbrake engage/ release lever down (3): The footbrake is engaged. Lift the footbrake engage/ release lever (2): The footbrake is released. M320 Ref. 10734261 / Version 02...

  • Page 18: Preperation Before Surgery

    Turn the optics/microscope carrier towards the outside. Unplug the power cable. NOTE Possible damage of the cable! Always pull the plug, never the cable. Tighten the articulation brake. Release the footbrakes. Open the articulation brake. M320 Ref. 10734261 / Version 02...
  • Page 19 CAUTION Risk of injury to feet! Always push the instrument to move it; never pull it. Tighten the footbrakes. CAUTION Danger of microscope rolling away on its own! Tighten the footbrakes. M320 Ref. 10734261 / Version 02...

  • Page 20: Installing The Accessories

    Insert until the handle Push the accessory into the sleeve clicks into place. dovetail interface. Push the knob and release Tighten the clamping screw. the handle sleeve. Documentation output C-mount port for commercially available video camera M320 Ref. 10734261 / Version 02...

  • Page 21: Ergonoptic Dent

    Handle tilt is individually ErgoWedge. adjustable. Refit the handle sleeve holder. Ideal in combination with 45° inclined binocular tube. For installation, see 7.2, "Installing the accessories" Insert until the handle sleeve clicks into place. M320 Ref. 10734261 / Version 02...

  • Page 22: Objectives

    The protective glass is used to protect the objective. The glass is steam- or gas-sterilizable. Tighten the rotary ring. Fine focusing objective: The nose points forward. Fixed objective: The nose points 90° towards the left or right. M320 Ref. 10734261 / Version 02...

  • Page 23: Adapters

    Install the stereo attachment for second observer on the left side. Fit the binocular tubes. Turn the white ring to align the cutout for the assistant. NOTE For installation, see 7.2, "Installing the accessories". M320 Ref. 10734261 / Version 02...

  • Page 24: Mounting Sterile Components

    Turn the rotary knob from objectives) or 90° to the zero to maximum brightness. left/right (fixed objectives). For the general preparation see chapter 6.1, "Illumination". Also check the brightness and filters before positioning the microscope above the patient. M320 Ref. 10734261 / Version 02...

  • Page 25: Changing The Accessories Of The Surgical Microscope And Balancing The Swing Arm

    Without looking into the eyepieces, set the minimum magnification (6.4×). The image on the monitor must remain sharp! Turn the dioptric correction on the eyepieces to "+5". M320 Ref. 10734261 / Version 02...

  • Page 26: Adjusting The Parfocality Without Camera And Monitor

    The writing should now remain sharp when you change the magnification. If it does not, repeat the procedure. Set maximum magnification (40×). Bring the writing on the sheet of paper into focus. M320 Ref. 10734261 / Version 02...

  • Page 27: Check The Remote Control And Camera

    A signal tone sounds. Set maximum magnification (40×). Turn out the eyecups to the desired distance. The writing should now remain sharp when you change the magnification. If it does not, repeat the procedure. M320 Ref. 10734261 / Version 02...

  • Page 28: Checklist Before Surgery

    • Footbrakes tightened • Proper fixation of all parts and accessories • Proper positioning at the operating table • Sterile components and drape installed • Illumination working properly • Remote control and camera working properly M320 Ref. 10734261 / Version 02...

  • Page 29: Operation

    White LED illumination on Plug the HDMI cable and the optics carrier lights up. USB cable (optional) into the horizontal arm and fasten it using cable ties. M320 Ref. 10734261 / Version 02...

  • Page 30: Adjusting The Design Led Illuminator

    Using a ball-point pen or Brakes could be overcome with muscle power. similar object, press the switch until the desired dimming level is reached. Screw in the cover of the horizontal arm and tighten M320 Ref. 10734261 / Version 02...

  • Page 31: Adjusting The Illumination

    In case of an illumination cooling fan failure an acoustic alarm appears (short beep every 5 seconds, lasting for Bring the surgical microscope 5 minutes). into transport position (see 7.1, "Transportation"). Switch off the surgical microscope at the main switch. M320 Ref. 10734261 / Version 02...

  • Page 32: Binocular Tubes

    For installation, refer to the separate Assembly Instructions provided. Double Iris Diaphragm Binocular tube, variable 30° - 150° For enhancing depth of field Inclined binocular tube 45° For installation, see 7.2, "Installing the accessories". M320 Ref. 10734261 / Version 02...

  • Page 33: Video Camera

    The live image and captured image do not show the same section one sees when looking through eyepieces. To simplify image centering, install 10× eyepiece with crosshair graticule. 10× eyepiece 12.5× eyepiece 4:3 aspect ratio 16:9 aspect ratio 4:3 section 16:9 section M320 Ref. 10734261 / Version 02...

  • Page 34: Sd Memory Card

    Format it at a computer or external digital camera. from the rear side. • The video camera is designed for SD memory cards up to 1 TB. • Leica recommends SD memory cards from SanDisk (Speed Class UHS-3 or better). Push down the cover flap. Replace the battery.

  • Page 35: On Screen Menu

    Arrow keys for navigation Enter / exit Camera Menu Start / stop video recoding Freeze live view / pause video Show / hide information menu Press to confirm. Arrow keys for navigation OK / confirm M320 Ref. 10734261 / Version 02...
  • Page 36 9.4.2 Exposure Manual exposure Select "MANUAL" for manual exposure. Correct the values for "EXPOSURE", "GAIN", and "GAMMA". Automatic exposure Select "AUTO" for automatic exposure. Correct the values for "BRIGHTNESS" and "GAMMA". M320 Ref. 10734261 / Version 02...
  • Page 37 The exposure is automatically adjusted based on the medium sized circle (“M CIRCLE”), as indicated on the screen. L Circle The exposure is automatically adjusted based on the large sized circle (“L CIRCLE”), as indicated on the screen. M320 Ref. 10734261 / Version 02...
  • Page 38 3840x2160 and 2704x2028 resolution is applicable to 4K video camera only Live Select the resolution for live view. Captured Select resolution for still image. Select quality for still image. Movie Select resolution for video file. Select quality of video file. M320 Ref. 10734261 / Version 02...
  • Page 39 • Show: Date/Time can be shown in still capture image or recorded video. Show filename Select the option for Show Filename: • Show: File name can be shown in still capture image or recorded video. M320 Ref. 10734261 / Version 02...
  • Page 40 • Flip Horizontal: Image is mirrored horizontally • Flip Vertical: Image is mirrored vertically • Flip Both: Image is rotated 180⁰ Audio/beep Select “ON” to have audio signal when capturing still images or initiating video recordings. M320 Ref. 10734261 / Version 02...
  • Page 41 Video Camera Show Logo Select “SHOW” to have “Leica” Logo on the “Live” view. Reset Camera Press to restore all settings of the video camera to the factory settings. M320 Ref. 10734261 / Version 02...
  • Page 42 • “OFF” • “1 SEC” • “3SEC” Show menu Select the display duration of the Camera Menu on the screen: • “10 SEC” • “15 SEC” • “INFINITE” Language Select the language. M320 Ref. 10734261 / Version 02...
  • Page 43 All the files will be saved in a folder, where the name of the folder is generated based on the file name set. e.g. Set Filename = m320 Filename = m32000001.JPG Folder name = 100m320_ Service For service use only M320 Ref. 10734261 / Version 02...
  • Page 44 SD card and pasted to the local PC. Applicable to USB port at horizontal arm only. Set filename Select “SET FILENAME” to enter “SET FILENAME” menu. Refer to "Set filename" section on page M320 Ref. 10734261 / Version 02...
  • Page 45 SD Card must be inserted to start Wifi Recommended software for Wifi streaming • iOS - Leica developed App and VLC streaming/ data transfer function. • Android - Leica developed App and VLC The camera cannot do still capture or •...
  • Page 46 “Removable Disk” MODE” and the SD card will on the computer. appear as “Removable Disk” on the computer. The camera cannot do still capture or recording to SD card while Wifi streaming is enabled. M320 Ref. 10734261 / Version 02...
  • Page 47 Navigate by using the Navigate by using the arrow keys. arrow keys. Press to select the Press to play the video. image. Image selected will be displayed in full screen. M320 Ref. 10734261 / Version 02...
  • Page 48 In order to achieve successful pairing and avoid pairing by mistake, the second step must be performed within 4 seconds. If a “timeout” is displayed after 4 seconds, press the “Pair” button again to start the process. M320 Ref. 10734261 / Version 02...

  • Page 49: Care And Maintenance

    Care and maintenance 10 Care and maintenance We recommend concluding a service contract with Leica Microsystems Service. 10.1 Care instructions Put a dust cover over the instrument during breaks in work. Keep accessories in a dust-free place when not in use.
  • Page 50 Care and maintenance 10.2.1 Tropical environment/fungus Leica Microsystems employs certain safety precautions in its manufacturing techniques and materials. Other preventive measures include: Keep optical parts clean. Use and store them in a clean environment only. Store under UV light when not in use.

  • Page 51: Notes On Reprocessing Of Resterilizable Products

    Cover, sterilizable for Leica M320 handle   1) 10448431 Protective objective glass, Leica M320  1) 10448296 Objective protective glass, Leica M720, spare part (package of  1) 10448280 Protective objective glass, Leica M720, complete, sterilizable 10448581 Cover, sterilizable for RUV800 ...
  • Page 52 Maintenance The Leica M320 surgical microscope is maintenance-free. To ensure operational safety and reliability, Leica Microsystems (Schweiz) AG recommends taking the precaution of contacting the responsible service organization. There, periodic inspections can be agreed or a maintenance contract can be concluded.

  • Page 53: Changing Fuses

    The fuse is in a fuse holder (arrow) in the device power socket. Remove cover of the horizontal arm. Push out fuse holder with screwdriver. Remove fuse from the fuse holder (arrow) and replace. Screw in the cover of the horizontal arm and tighten it. M320 Ref. 10734261 / Version 02...

  • Page 54: Disposal

    Disposal 11 Disposal The respective applicable national laws must be observed for disposal of the products, with the involvement of corresponding disposal companies. The unit packaging is to be recycled. M320 Ref. 10734261 / Version 02...

  • Page 55: What To Do If

    Beep every 5 seconds, light Contact service technician, have fan replaced. switches off automatically after five  minutes. Double beep every 5 seconds, Allow the LED to cool off, switch off the instrument. light switches off automatically after 5 minutes. M320 Ref. 10734261 / Version 02...

  • Page 56: Video Camera

    Colors not accurate. Carry out white balance. See 9.4.1, "Color (white balance)" File Transfer not possible. Check USB cable connection. If your instrument has a malfunction that is not described here, contact your Leica representative. M320 Ref. 10734261 / Version 02...

  • Page 57: Specifications

    Average service life of 60,000 h for an end-of-life criterion of 70 % of the initial brightness; UV filter UV and IR-free LED illumination Orange filter OG530 Light intensity adjustment Using a drive knob on the optics carrier M320 Ref. 10734261 / Version 02...

  • Page 58: Stands

    ErgoWedge 5°- to 25°-angle for binocular tubes with fixed angle ErgonOptic Dent With 52° swivel angle, for binocular tubes variable from 0° to 180° Remote control IR remote control for the integrated video camera M320 Ref. 10734261 / Version 02...

  • Page 59: Video Accessories

    Spacer for assembly of the beam splitter Eyepieces 8.33×, 10×, 10× with crosshair graticule, 12.5× 13.7 Video accessories M320 4K/FULL HD Video & Photo Camera Integrated (optional) video camera 3840×2160/1902x1080 px video resolution and 12Mpx photo resolution Functions Playback function for video and photo and thumbnail view...

  • Page 60: Electromagnetic Compatibility (Emc)

    ±1 kV differential mode; ±2 kV common mode Conducted disturbances, induced by RF fields 10 V rms Rated power-frequency magnetic field 30 A/m Voltage dips and interruption according to IEC 60601-1-2:2014 Rated power-frequency magnetic field Not applicable M320 Ref. 10734261 / Version 02...

  • Page 61: Standards Fulfilled

    ISO/13485 for quality management and quality assurance. 13.12 Limitations on use • The Leica M320 surgical microscope may be used in enclosed rooms and on flat surfaces with max. 0.3° unevenness and on stable walls or ceilings that fulfill our specifications (see Installation Manual).

  • Page 62: Working Range

    ±155° extension arm ±155° extension arm ±150° movement ±60° Lateral microscope carrier Lateral microscope carrier Lateral microscope carrier movement ±60° movement ±60° movement ±60° 46 kg 41 kg 38 kg 30 kg M320 Ref. 10734261 / Version 02...

  • Page 63: Dimensions F12 (In Mm)

    Specifications 13.14 Dimensions F12 (in mm) Max. 1775 M320 Ref. 10734261 / Version 02...
  • Page 64 Notes M320 Ref. 10734261 / Version 02...
  • Page 65 Notes M320 Ref. 10734261 / Version 02...
  • Page 66 10734261en/02 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2021 • Printed – 10.2021 – Subject to modifications. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH. Leica Microsystems (Schweiz) AG · Max Schmidheiny Strasse 201 · CH-9435 Heerbrugg T +41 71 726 3333 ·...

This manual is also suitable for:

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