Leica M844 User Manual
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Leica M844 User Manual

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M844
User Manual
10 713 294 - Version 01

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Summary of Contents for Leica M844

  • Page 1 M844 User Manual 10 713 294 - Version 01...
  • 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

    Camera, video 7.12 Stand settings (F20) 7.13 Positioning at the operating table Specifications 7.14 Attaching sterile controls and drape 14.1 Microscope 7.15 Function check 14.2 Illumination 14.3 Accessories Operation 14.4 Electrical data M844 / Ref. 10 713 294 / Version 01...
  • Page 4 14.13 List of weights of balanceable configurations 14.14 Dimensional drawings Annex 15.1 Checklist before the operation This manual covers the following systems: • M844 F40 • M844 F20 • M844 CT40 M844 / Ref. 10 713 294 / Version 01...

  • Page 5: Introduction

    Enter this data in your user manual and always refer to it when In this user manual the surgical microscope M844 is described. you contact us or the service workshop regarding any questions you may have.

  • Page 6: Safety Notes

    • The M844 surgical microscope may be used only in closed • Only the following accessories may be used with the Leica M844 rooms and must be placed on a solid floor. surgical microscope: •...

  • Page 7: Directions For The Operator Of The Instrument

    • Pupils dilated to 7 mm no closer than 30 cm (12 inches) to any part of the Leica M844, including cables specified by the manufacturer. Otherwise, 1) 2) The calculations are based on the corresponding ISO standards degradation of the performance of this equipment could result.

  • Page 8: Dangers Of Use

    Protect the patient with the following safeguards: Accessories • Short illumination times Only the following accessories may be used with the Leica M844 • Low brightness setting surgical microscopes: • Use of protective filters • The Leica Microsystems accessories described in this User •...
  • Page 9 During exposure to the light from this instrument, do obstructions. not exceed the hazard reference values. An exposure to this instrument for longer than 2 min at maximum output power exceeds the exposure limits. M844 / Ref. 10 713 294 / Version 01...
  • Page 10 XY, zoom and focus motors are free of WARNING obstructions. The tilt motor is not moved. Risk of infection. Always use the M844 surgical with sterile controls and a WARNING sterile drape. Danger of fatal electric shock!
  • Page 11 When handling the slit illuminator, take care not to crush any fingers. CAUTION There is a risk of damage to the surgical microscope from uncontrolled tilting! Firmly hold the handles before triggering the "All Brakes" function. M844 / Ref. 10 713 294 / Version 01...

  • Page 12: Signs And Labels

    Safety notes Signs and labels Floor stand, horizontal arm, and swing arm F20 10,15 8, 16 M844 / Ref. 10 713 294 / Version 01...
  • Page 13 Max. 10.5kg (23.15lb) monitor arm Max. load for Max. 11.5kg (25.35lb) optics carrier Fabrication label a Reference number b Serial number Transport position (F20 floor stand) Danger sign for squeezing hazard M844 / Ref. 10 713 294 / Version 01...
  • Page 14 "Hospital only" or "Hospital Grade". La fiabilité de la mise à la terre n'est assurée que si l'équipement est connecté à une prise équivalente, mar quée "Hôpital seulement" ou "Qualité hôpital". M844 / Ref. 10 713 294 / Version 01...
  • Page 15 19 UDI Label ANVISA Registration number (only brazil) INMETRO label (only brazil) Max. load monitor arm OCP 0004 Max. 8.5kg (18.74lb) Fabrication label a Reference number Tilting danger b Serial number MET label M844 / Ref. 10 713 294 / Version 01...
  • Page 16 Leica Telescope Mount Type labels Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL LEICA M844 / M822 C40 100 V - 240 V 50-60 Hz 100 VA 2x T6.3 AH/250V M844 / Ref. 10 713 294 / Version 01...

  • Page 17: Design

    12 Base 5 Binocular tube 13 Holding fixture for video control unit 6 0° assistant’s attachment (Leica M844 only) 14 Hand rail 7 Handles 15 Suspension device for footswitch 8 Optics carrier M844 / Ref. 10 713 294 / Version 01...
  • Page 18 Never connect secondary devices to the auxiliary power 25 Socket for potential equalization socket unless they conform to the specifications. For connecting the Leica M844 to an equipotential bonding Requirements of use, see chapter 14.5 device. This is part of the customer's building installation.

  • Page 19: Leica M844 F20

    5 Binocular tube 12 Holding fixture for video control unit 6 0° assistant’s attachment (Leica M844 only) 13 Hand rail 7 Handles 14 Suspension device for footswitch 15 Optional monitor arm M844 / Ref. 10 713 294 / Version 01...
  • Page 20 11 Socket for potential equalization Requirements of use, see chapter 14.5 For connecting the Leica M844 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7).

  • Page 21: Leica M844 Ct40

    11 Wall mount for control unit (optional) 4 XY-unit 12 CT40 telescope mount 5 Binocular tube 6 0° assistant’s attachment (Leica M844 only) 7 Handles 8 Optics carrier Assembly of the ceiling mount: see enclosed installation instructions. M844 / Ref. 10 713 294 / Version 01...
  • Page 22 9 Power supply 10 Fuse holder (2× 6.3 AH, time-lag) 11 Running-time meter for the surgical microscope 12 Socket for potential equalization For connecting the Leica M844 to an equipotential bonding device. This is part of the customer's building installation. CAUTION Observe the requirements of EN 60601-1 (§...

  • Page 23: Leica M844 Optics Carrier

    • Optics carrier with integrated illumination • Interface for assistants, either to the left and right side • Main surgeon interface, 180° rotatable The Leica Accessories functions are described in the corresponding user manuals. M844 / Ref. 10 713 294 / Version 01...

  • Page 24: Functions

    Electromagnetic brakes (F40 only) The M844 surgical microscope has 4 electromagnetic brakes which stop the movements of the stand and surgical microscope. They are operated by turning the handles. M844 / Ref. 10 713 294 / Version 01...

  • Page 25: Controls

    ADF 1 and 2 are digital relay outputs that can switch 24 V/2 A. may be connected here. During operation, use only the cables provided for CAN and footswitch in order to prevent malfunctions. M844 / Ref. 10 713 294 / Version 01...

  • Page 26: Leica M844 Surgical Microscopes

    Leica M844 only) 3 OCF "Optics Carrier Functions" 8 Rotary knob for tilt drive (motorized) Only the Leica Slit Illuminator, Oculus SDI, or other Leica 9 Magnification display with XY-reverse display devices may be connected here. 10 Focus reset...

  • Page 27: Footswitch And Handles

    Handles Main light+ Ottoflex Light+ Focus+ Focus– Selected Brake Selected Brake Magnification+ Magnification– Main light– Ottoflex Light– Y– All Brakes All Brakes Handles Selected Brake Selected Brake All Brakes All Brakes M844 / Ref. 10 713 294 / Version 01...

  • Page 28: Preparation Before Surgery

    Always lock the footbrake when you are not moving the system. CAUTION Whenever you transport your Leica M844 F20, first bring it into the Danger of injury from uncontrolled lateral movement of the transport position. system and arm systems.

  • Page 29: Installing Optical Accessories

    Complete all preparations and adjustments to the stand NOTE before the operation. There is a risk of damage to the Leica M844 F40 surgical microscopes Never change the accessories or attempt to rebalance from uncontrolled tilting! the microscope while it is above the field of operation.

  • Page 30: Setting The Binocular Tube

    Select the minimum magnification. Place a flat test object with sharp contours under the lens at working distance. Focus the microscope. Set the maximum magnification. M844 / Ref. 10 713 294 / Version 01...

  • Page 31: Adjusting Optical Accessories For Leica M844

    Zoom through the whole range, observing the test object. The image sharpness must remain constant at all magnifications. If this is not the case, check diopter settings of the eyepieces. M844 / Ref. 10 713 294 / Version 01...

  • Page 32: Installing Documentation Accessories

    Secure the camera, complete with adapter, in the phototube. Tighten the clamping screw. Please refer to section 10.3 for a list of video accessories. Rotate the fine focusing knob (4) to focus the image seen by the assistant accurately. M844 / Ref. 10 713 294 / Version 01...

  • Page 33: Selecting Documentation Accessories

    100 mm 107 mm 1/4 “ 1/2.8 “ 1/3 “ 1/2 “ 2/3 “ 1 “ Brennweite Video Adapter Video adapter focal length 250 mm 350 mm 250 mm 350 mm M844 / Ref. 10 713 294 / Version 01...

  • Page 34: Fitting Optical Accessories For Leica M844

    We recommend that, for the main surgeon, the UltraLow™ III binocular tube be used in combination with the double wing. The UltraLow™ III binocular tube offers better ergonomic conditions. M844 / Ref. 10 713 294 / Version 01...

  • Page 35: Fitting The Leica Slit Illuminator

    The slit illuminator may only be used with an objective (10445937) with a working distance (WD) of 200 mm. Insert the 3-pin plug of the dual cable into the external supply socket (4) on the optics carrier. M844 / Ref. 10 713 294 / Version 01...
  • Page 36 When handling the slit illuminator, take care not to crush any fingers. To activate the slit illuminator, use the OttoFlex/slit illuminator switch (5) on the optics carrier (see chapter 6.2 ). M844 / Ref. 10 713 294 / Version 01...
  • Page 37 Move the slit illuminator to the right or left with the handswitch (1). The slit tube of the slit illuminator can be protected by sterile cover (3), the lever for adjusting the slit width can be protected by sterile cover (4). M844 / Ref. 10 713 294 / Version 01...

  • Page 38: Wide-Angle Observation System (Such As Oculus)

    You can control the wide-angle observation system using any other ophthalmological instrument using a bright visible light your Leica footswitch by assigning the OCF1, BIOM Focus + source within the previous 24 hours. This applies especially if the and BIOM Focus – functions in the Extras function group: eye was examined by retina photography.

  • Page 39: Stand Settings (F40, Ct40)

    Turn one handle to release the brakes (All Brakes). Check whether the microscope drifts up or down. Microscope drifts downwards: Turn rotary knob (1) clockwise. Microscope drifts upwards: Turn rotary knob (1) counterclockwise. M844 / Ref. 10 713 294 / Version 01...
  • Page 40 The CT40 must stop. The brakes can also be released using a remote brake release. Press and hold the remote brake release button. All brakes on the stand are now released. M844 / Ref. 10 713 294 / Version 01...

  • Page 41: Stand Settings (F20)

    Hold the handle when releasing the brake. easier or more difficult to move. The M844 can be positioned easily on the operating table and Make the joint easier to move: offers a variety of possibilities for operations on the head or spinal Loosen the black brake knob (3).

  • Page 42: Attaching Sterile Controls And Drape

    Packaging the footswitch in a plastic bag protects it against WARNING dirt. Risk of infection. Always use the M844 surgical with sterile controls and a 7.14.3 Sterile drape for stand sterile drape. Only use the sterile Leica tested drapes specified in the Accessories section.

  • Page 43: Function Check

    7.14.4 Attaching the protective glass to the objective Place the sterilized protective glass on the optics carrier so that the markings on the M844 (1) and on the protective glass (2) are aligned. Insert the protective glass upwards into the bayonet mount in direction (a).

  • Page 44: Operation

    Minimize exposure to eyes or skin. • The illumination is switched off. Use appropriate shielding. If you move your Leica M844 back down over the operating field, the illumination switches back on and your Leica M844 is ready to use immediately.

  • Page 45: Positioning The Microscope

    • Also refer to the "Releasing the brakes" chapter 7.11.4. • If a drive is in reset position, the "Reset" button assigned to it • Adjust the articulation brake for Leica M844 F20 appears in green. according to personal requirements and weight of the •...

  • Page 46: Adjusting The Microscope

    • Setting the brightness of a lamp to zero switches it off. • The Leica M844 is also equipped with a second OttoFlex™ light source.The combined output of the two light sources is limited electronically.
  • Page 47 • If a slit illuminator is active, it is not switched off if a filter slide is inserted. After the filter has been removed, the OttoFlex™ illuminator can be switched back on using the footswitch or at the control unit. M844 / Ref. 10 713 294 / Version 01...

  • Page 48: Adjusting The Magnification (Zoom)

    "Depth Enhancer" button. In the "User Settings" menu, you can assign a default status of the double-iris diaphragm for each user, or assign it as a footswitch function, under "Tube Settings".. M844 / Ref. 10 713 294 / Version 01...

  • Page 49: Transport Position

    Touch panel Touch panel Transport position Whenever you transport your Leica M844 F40, first bring it into Menu structure transport position (see chapter 7.1). • Transporting the M844 F20 (see chapter 7.1.1) • Transporting the Leica M844 F40 (see chapter 7.1.2) Rest position Bring the microscope into rest position after use.
  • Page 50 • The illumination is switched off. times. If you move your Leica M844 back down over the operating field, When you select a user, an informational screen for that user the illumination switches back on and your Leica M844 is ready to appears that specifies the tube settings that are needed, as well as use immediately.

  • Page 51: Editing The User List

    Click the "Save" button to save the user at the desired location not changed. under the name you have entered. We recommend that you do not change the configuration of the user settings or edit the user list during an operation. M844 / Ref. 10 713 294 / Version 01...
  • Page 52 If you click the "Cataract" or "Retina" button, the selected footswitch is assigned the default settings. You can then modify these settings as you like. Clicking the "Clear All" button clears the assignments for all keys. M844 / Ref. 10 713 294 / Version 01...
  • Page 53 • Light – control of the illumination • Reset – reset an individual function or all functions • DI C800 – control of the Leica DI C800, see separate user manual • XY-Function – control of the XY-unit The "toggle" function changes the status of a function (e.g.

  • Page 54: Stepcycle

    On this screen, you can enable or disable the desired StepCycle™ parameters for the individual users. When cycling through the StepCycle™ function, only the actively set parameters for the individual user are activated. M844 / Ref. 10 713 294 / Version 01...
  • Page 55 Footswitch VR), "VR Mode on/off" must be assigned. • If the "VR Mode on/off" function is assigned to "Footswitch" in the footswitch assignment, it is automatically applied to the same button at "Footswitch VR". M844 / Ref. 10 713 294 / Version 01...
  • Page 56 Using VR mode Press the button with the "VR Mode on/off" (1) assignment. On this screen, the settings are configured for a connected Leica DI VR mode is activated. The actions activated in the user settings are C800 for data superimposition; see separate user manual.

  • Page 57: The Maintenance Menu

    In the top right selection field, select the connection you are magnification is displayed, regardless of the accessories using. used. The magnification range is between 7x and 42x. You can scroll forwards or backwards in the list by clicking the arrowheads. M844 / Ref. 10 713 294 / Version 01...

  • Page 58: The "How To

    This screen displays short summaries of various aspects of the operation of your surgical microscope. The "Help" button in the static menu bar provides access to the "How To..." pages at all times. The "Service" menu This area is password-protected. M844 / Ref. 10 713 294 / Version 01...

  • Page 59: Accessories

    Accessories 10 Accessories A comprehensive range of accessories enables the M844 surgical microscope to be matched to the requirements of the task in hand. Your Leica representative will be pleased to help you select the appropriate accessories. 10.1 Devices and accessories manufactured by Leica...
  • Page 60 • For further information, see the separate operating instructions • For observing the fundus of the patient's eye Leica RUV800 WD175 • For further information, see the separate operating Leica RUV800 WD200 instructions M844 / Ref. 10 713 294 / Version 01...
  • Page 61 Accessories Image Component/accessory Description Leica Slit Illuminator Holder for protective glass Protective glass Oculus BIOM Enfocus M844 / Ref. 10 713 294 / Version 01...

  • Page 62: Devices And Accessories Of Leica And Of 3Rd Party

    Accessories 10.2 Devices and accessories of Leica The parfocality of the Leica Zoom Video Adapter has to be and of 3rd party manufacturers adjusted. Set the maximum magnification. 10.2.1 HD Recording Systems Place a flat test object with sharp contours under the objective.

  • Page 63: Care And Maintenance

    Leica Foot switch It is recommended to conclude a service contract with Leica Service. After each operation, clean the Leica footswitch in warm or hot water (but below 60 °C). It is basically maintenance-free. In case of 11.2 Cleaning the touch panel defects, please contact the responsible service organization.

  • Page 64: Changing Fuses

    Pull on the tab to remove the bulb socket complete with bulb. arm. Insert the new bulb socket and bulb. Remove the fuse (4) from the holder and replace it. Use only 1 AH time-lag fuses. M844 / Ref. 10 713 294 / Version 01...

  • Page 65: Notes On Reprocessing Of Resterilizable Products

    Rinse surface contamination off of the product (temp. < 40 °C). Use some rinsing agent depending upon degree of contamination. Alcohol may also be used to clean the optics if heavy contamination such as fingerprints, grease streaks etc. is present. M844 / Ref. 10 713 294 / Version 01...
  • Page 66 In general, this requires validations and routine monitoring of the process. Every deviation from the supplied instructions should also be examined carefully by the processing person to determine effectiveness and possible detrimental consequences. M844 / Ref. 10 713 294 / Version 01...
  • Page 67 1) This medical device falls within the validated stertility claims of the STERRAD®100S / STERRAD® 100NX / STERRAD®50 / STERRAD®200 Systems. Follow the instructions for use of your STERRAD® System User's Guide prior to sterilizing devices in STERRAD® Systems. M844 / Ref. 10 713 294 / Version 01...

  • Page 68: Disposal

    Check the position of the OttoFlex™/slit illuminator switch (see item 6, chapter 6.2) and set it to OttoFlex. A bulb is defective. Cause 3: Fault remedy: Check the bulbs and replace any that are defective (see chapter 11.6). M844 / Ref. 10 713 294 / Version 01...

  • Page 69: Control Unit

    The display is defective. Cause 3: Fault remedy: Contact your Leica Microsystems representative. You can still work with your Leica Microsystems surgical microscope. All functions can still be operated using the footswitch. M844 / Ref. 10 713 294 / Version 01...

  • Page 70: Error Messages On The Control Unit

    Contact your Leica Microsystems representative. 13.6 CT40 ceiling mount Fault: The Leica CT40 cannot be moved up or down. The Leica CT40 is protected by a temperature switch that switches off in Cause 1: Fault remedy: case of overheating. Wait approximately 30–45 minutes until the telescope motor has cooled off.

  • Page 71: Camera, Video

    Fault remedy: Replace the fuse. Fault: Images are blurry The parfocality of the Leica Video Adapter is not adjusted properly. Cause 1: Fault remedy: Check the parfocality of the microscope (see page 66). The parfocality of the microscope is not set properly.

  • Page 72: Specifications

    All controls can be sterilized, sterile Variable field diameter from 4 to 35 mm drapes are available at WD 200 mm Leica Keratoscope Precision-formed halogen bulb 12 V/50 W * Accessories from third-party manufacturers M844 / Ref. 10 713 294 / Version 01...

  • Page 73: Electrical Data

    12.5× Max. permitted ground leakage current for the Leica M844 F40 including secondary device, IEC/EN 60601-1: 5 mA Leica M844 CT40 including secondary device, UL 60601-1: 300 µA Leica M844 F20 including secondary device: M844 / Ref. 10 713 294 / Version 01...

  • Page 74: Stands

    10 % to 100 % rel. humidity Turning range Axis 1 (at the column): 360° 500 mbar to 1060 mbar Axis 2 (in the center): +180°/–135° atmospheric pressure Axis 3 (over XY-unit): ±270° M844 / Ref. 10 713 294 / Version 01...

  • Page 75: Electromagnetic Compatibility (Emc)

    • The equipment is allowed a deviation at the immunity levels (0% of nominal voltage for 5 s), provided the equipment remains safe, experiences no component failures and is restorable to the pre-test state with operator intervention. M844 / Ref. 10 713 294 / Version 01...

  • Page 76: Limitations Of Use

    The Leica M844 F20 and the Leica M844 F40 are not suitable for crossing thresholds higher than 20 mm. Without auxiliary equipment, the Leica M844 F20 and the Leica M844 F40 can only be moved across thresholds up to a max. height of 5 mm. To move the Leica M844 F20 and the Leica M844 F40 over thresholds of 5-20 mm, the wedge (1) included in the packaging can be used.
  • Page 77 Figure 6 - Strap fixation of monitor Storing the microscope on an inclined plane (F20 only): Use the wedge provided in the transport box (Figures 7 - 8) . Figure 7 Figure 8 M844 / Ref. 10 713 294 / Version 01...

  • Page 78: List Of Weights Of Balanceable Configurations

    Specifications 14.13 List of weights of balanceable configurations For the Leica Leica M844 F40, drift effects must be taken into account on floors which slant >0.3°. Equipment Leica M844 serial number ............ Max. load for stand from microscope interface ... kg...
  • Page 79 Leica Remote Video Adapter (RVA) 0.44 kg 10448290 Leica Manual Video Adapter (MVA) 0.42 kg 10448584 Leica HD C100 (optical head and cable) 0.64 kg Load This list contains typical equipment articles. Subject to change. M844 / Ref. 10 713 294 / Version 01...

  • Page 80: Dimensional Drawings

    Specifications 14.14 Dimensional drawings 14.14.1 Dimensional drawing (mm) for Leica M844 F40 M844 / Ref. 10 713 294 / Version 01...
  • Page 81 Specifications 14.14.2 Dimensional drawing (mm) for Leica M844 CT40 Axis of rotation M844 / Ref. 10 713 294 / Version 01...
  • Page 82 Specifications 14.14.3 Dimensional drawing (mm) for Leica M844 F20 M844 / Ref. 10 713 294 / Version 01...

  • Page 83: Annex

    Check the user settings on the control unit for the selected user. Positioning at the OP table Position the M844 on the OP table as required and lock the foot brake (chapter 7.1.1 or chapter 7.1.2). Sterility Fit sterile components and sterile drape if used (see chapter 7.14).
  • Page 84 Annex M844 / Ref. 10 713 294 / Version 01...
  • Page 85 Annex M844 / Ref. 10 713 294 / Version 01...
  • Page 86 10 713 294en/01 •Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2022 • Printed – 02.2022 • Subject to modifications • LEICA and the Leica Logo are CONNECT registered trademarks of Leica Microsystems WITH US! Leica Microsystems (Schweiz) AG · Max Schmidheiny Strasse 201 · CH-9435 Heerbrugg T +41 71 726 3333 ·...

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