Leica M822 User Manual
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Leica M822 User Manual

Surgical microscope system
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M822
User Manual
10 743 504 - Version 01

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  • Page 1 M822 User Manual 10 743 504 - 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

    Stand settings (F40, C40) 13.5 F20 stand 7.10 Positioning at the operating table 13.6 F40 stand 7.11 Attaching sterile controls and drape 13.7 C40 ceiling mount 7.12 Function check 13.8 Camera, video M822 / Ref. 10 743 504 / 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: • M822 F40 • M822 F20 • M822 C40 M822 / Ref. 10 743 504 / 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 M822 is described. you contact us or the service workshop regarding any questions you may have.

  • Page 6: Safety Notes

    • The M822 surgical microscope may be used only in closed rooms • Only the following accessories may be used with the Leica M822 and must be placed on a solid floor.

  • Page 7: Directions For The Operator Of The Instrument

    “ME Systems” must be observed. damage increases with the duration of exposure. • All parts of the M822 shall not be serviced or maintained while During exposure to the light from this instrument, do in use with a patient.
  • Page 8 Accessories of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Only the following accessories may be used with the Leica M822 Non-Ionizing Radiation Protection (ICNIRP) APPLIED OPTICS, Vol. surgical microscopes: •...

  • Page 9: Dangers Of Use

    The footswitch function for moving the ceiling mount Always push the M822 surgical microscope; never pull it. up and down may not be used in combination with accessories that cause the working distance to fall below WArNINg the minimum of 140 mm.
  • Page 10 In case of malfunction of the fans, the maximum light output is reduced. WArNINg risk of infection. Always use the M822 surgical with sterile controls and a WArNINg sterile drape. risk of injury from downward movement of surgical microscope!
  • Page 11 Motors return to their home positions Connecting unauthorized secondary devices to the auxiliary Before switching on your Leica M822, ensure that the power socket can lead to damage to the surgical microscope travel paths of the XY, zoom and focus motors are free of and to the secondary device! obstructions.

  • Page 12: Signs And Labels

    Safety notes Signs and labels Horizontal arm and swing arm F20 4, 5 M822 / Ref. 10 743 504 / Version 01...
  • Page 13 TT = day (2 digits) h Production starting date Type label INMETRO label (only brazil) Max. power output MET label Equipotential bonding ANVISA Registration ANVISA Reg. No number (only brazil) XXXXXXXXXX M822 / Ref. 10 743 504 / Version 01...
  • Page 14 "Hospital only" or "Hospital Grade". La abilité 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". M822 / Ref. 10 743 504 / Version 01...
  • Page 15 Incremental number starting at 1 for each batch e JJ = year (2 digits) f MM = month (2 digits) g TT = day (2 digits) h Production starting date M822 / Ref. 10 743 504 / Version 01...
  • Page 16 Safety notes Leica Telescope Mount Type labels M822 / Ref. 10 743 504 / Version 01...

  • Page 17: Design

    4 XY-unit 11 Base 5 Binocular tube 12 Holding fixture for video control unit 6 0° assistant’s attachment (Leica M822 only) 13 Hand rail 7 Handles 14 Suspension device for footswitch M822 / Ref. 10 743 504 / Version 01...
  • Page 18 11 Socket for potential equalization Requirements of use, see chapter 14.5. For connecting the Leica M822 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 19: Leica M822 F40

    4 Handles 12 Suspension device for footswitch 5 Optics carrier 13 Holding fixture for video control unit 6 Binocular tube 14 Control unit 7 Tilt head 15 Horizontal arm 8 Column M822 / Ref. 10 743 504 / Version 01...
  • Page 20 Never connect secondary devices to the auxiliary power 11 Socket for potential equalization socket unless they conform to the specifications. For connecting the Leica M822 to an equipotential bonding Requirements of use, chapter 14.5. device. This is part of the customer's building installation.

  • Page 21: Leica M822 C40

    11 Wall mount for control unit (optional) 4 XY-unit 12 C40 ceiling mount 5 Binocular tube 6 Attachment for second observer 7 Handles 8 Optics carrier Assembly of the ceiling mount: see enclosed installation instructions. M822 / Ref. 10 743 504 / 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 M822 to an equipotential bonding CAUTION device. Connecting unauthorized secondary devices to the auxiliary This is part of the customer's building installation.

  • Page 23: Leica M822 Optics Carrier

    • Interface for assistants, either to the left and right side • Main surgeon and back assistant interface, 360° rotatable both The Leica Accessories functions are described in the corresponding user manuals. M822 / Ref. 10 743 504 / Version 01...

  • Page 24: Functions

    They are operated by turning the handles. The illumination of the surgical microscope Leica M822 is a main light (1) and a OttoFlex II™ light (2). They are located in the optics carrier.

  • Page 25: Controls

    14 CAN external During operation, use only the cables provided for CAN, Only devices verified by Leica Microsystems, Medical Division, video and footswitch in order to prevent malfunctions. may be connected here. M822 / Ref. 10 743 504 / Version 01...

  • Page 26: Leica M822 Surgical Microscopes

    7 Manual zoom emergency drive 13 OCF "Optics Carrier Functions" 8 Quick-change lamp mount Only the Leica Slit Illuminator, Oculus BIOM, or other Leica 9 Lamp cover opener devices may be connected here. M822 / Ref. 10 743 504 / Version 01...

  • Page 27: Footswitch And Handles

    See also User manual Wireless Footswitch, 14 functions. Footswitch and handles can be assigned individually for each user in the configuration menu (see chapter 9.6.4 and chapter 9.6.8). 6.3.1 Standard configuration "Cataract" Handles Handles M822 / Ref. 10 743 504 / Version 01...

  • Page 28: Preparation Before Surgery

    Preparation before surgery 7.1.1 Transporting the Leica M822 F20 Transport position Transportation Before transporting your Leica M822 F20, always return it to the transport position. WArNINg Unplug and secure the power cable. Danger of injury due to: Pull the stop lever (1) and turn it into a horizontal position.

  • Page 29: Installing Optical Accessories

    Installing optical accessories 7.1.2 Transporting the Leica M822 F40 Transport position WArNINg Before transporting your Leica M822 F40, always return it to the risk of injury due to downward movement of the surgical transport position. microscope. Unplug and secure the power cable.

  • Page 30: Setting The Binocular Tube

    Carefully insert the tube and tighten the clamping screw. chapter 9.6.9). The stored value can be read out with "Show Settings". Fitting eyepieces Affix the eyepieces with the fixing rings in the tubes. M822 / Ref. 10 743 504 / Version 01...

  • Page 31: Adjusting The Eyepiece

    Without looking into the eyepieces, turn both eye lenses to +5 diopters. Slowly turn the eyepieces towards –5 individually for each eye until the test object appears in sharp focus. Select the highest magnification and check the sharpness. M822 / Ref. 10 743 504 / Version 01...

  • Page 32: Selecting Documentation Accessories

    70 mm 85 mm 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 M822 / Ref. 10 743 504 / Version 01...

  • Page 33: Adjusting The Leica Slit Illuminator

    Lock the swing arm in place. Loosen the 2 screws (2) and remove the lever (1) for the quick- 7.6.3 Install the intermediate plate change lamp mount. Install the intermediate plate (5) with screw (6). M822 / Ref. 10 743 504 / Version 01...
  • Page 34 The slit illuminator must be removed for lamp replacement. Make sure that the interlock latches securely. Loosen the clamp screw (7) and slide the slit lamp (14) into the guide (13). Tighten the clamping screw (7). M822 / Ref. 10 743 504 / Version 01...
  • Page 35 Dim the slit illuminator before switching it on. When removing the slit illuminator, make sure that both Slowly increase the brightness until the image is stoppers (16) are in the bottom position. illuminated optimally for the operating doctor. M822 / Ref. 10 743 504 / Version 01...
  • Page 36 The width of the slit can be adjusted with the lever (3) on the lamp housing of the slit lamp. The slit widths can be adjusted from 0.01 to 14 mm. The slit height is 14 mm. M822 / Ref. 10 743 504 / Version 01...

  • Page 37: Wide-Angle Observation System (Such As Oculus)

    • Photochemical damage to the retina is one possible complication due to the necessity of using bright light to visualize eye structures during difficult ophthalmologic processes. M822 / Ref. 10 743 504 / Version 01...

  • Page 38: Stand Settings (F20)

    • The SDI is mounted directly on the optics carrier of the Make the joint easier to move: Leica M822. If a beam splitter is to be used in addition, Loosen the black brake knob (1). mount it on the SDI using a stereo adapter (10446992).

  • Page 39: Stand Settings (F40, C40)

    After re-equipping, always rebalance the microscope on NOTE the swing arm. There is a risk of damage to the Leica M822 F40 surgical microscopes from uncontrolled tilting! Firmly hold the handles before triggering the "All Brakes" function.
  • Page 40 The C40 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. M822 / Ref. 10 743 504 / Version 01...

  • Page 41: Positioning At The Operating Table

    Don't use the down / up movement of ceiling mount when the microscope is over the patient. NOTE There is a risk of damage to the Leica M822 F40 surgical microscopes from uncontrolled tilting! Firmly hold the handles before triggering the "All Brakes"...

  • Page 42: Function Check

    7.11.4 Attaching the protective glass to the objective Place the sterilized protective glass on the optics carrier so that the markings on the M822 (1) and on the protective glass (2) are aligned. M822 / Ref. 10 743 504 / Version 01...

  • Page 43: Operation

    WArNINg Danger of fatal electrical shock. In operational mode, the status line displays the current The M822 surgical microscope may be connected to a user and specifies the current location in the menu at all grounded socket only. times.
  • Page 44 The microscope tilts in the desired direction. • The microscope can be tilted 15° forwards and 50° backwards. • Pressing the "Reset" button on the control unit returns the microscope to home position (0°). M822 / Ref. 10 743 504 / Version 01...

  • Page 45: Adjusting The Microscope

    • Setting the brightness of a lamp to zero switches it off. • The Leica M822 is also equipped with a second OttoFlex™ II light source.The combined output of the two light sources is limited electronically.

  • Page 46: Adjusting The Magnification (Zoom)

    In the "User Settings" menu, you can assign a default status p. 2162 (10 April 2005). of the double-iris diaphragm for each user, or assign it as a footswitch function, under "Tube Settings". M822 / Ref. 10 743 504 / Version 01...

  • Page 47: Transport Position

    "Speed" menu (see chapter 8.2.5 ). NOTE • You can return the focus motor to the reset position (1/3 There is a risk of damage to the Leica M822 F40 surgical microscopes up, 2/3 down) by pressing the "Reset" key (2, from uncontrolled tilting! chapter 6.2) or the "Reset Focus"...

  • Page 48: Rest Position

    Lock the swing arm. • If DVI mode is active, the DVI signal (e.g. Leica MDRS4 video Switch off the power switch on the swing arm. system) is displayed and both LEDs light up.

  • Page 49: Menu Structure

    • The current user settings are reloaded. Switching the microscope on • The illumination is switched off. If you move your Leica M822 back down over the operating field, WArNINg the illumination switches back on and your Leica M822 is ready to Motors return to their home positions use immediately.

  • Page 50: Editing The User List

    Renames an existing user.The user's settings are rename not changed. We recommend that you do not change the configuration of the user settings or edit the user list during an operation. M822 / Ref. 10 743 504 / Version 01...

  • Page 51: Configuring Users (User Settings Menu)

    If you like, you can edit the user list first. Enter the desired username using the keyboard. Click the "Save" button to save the user at the desired location under the name you have entered. M822 / Ref. 10 743 504 / Version 01...
  • Page 52 • Reset – reset an individual function or all functions If you click the "Cataract" or "Retina" button, the selected • DI C800 – control of the Leica DI C800, see separate user manual footswitch is assigned the default settings. • XY-Function – control of the joystick You can then modify these settings as you like.
  • Page 53 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. M822 / Ref. 10 743 504 / Version 01...
  • Page 54 If you load a new user or trigger an Auto Reset, you are returned to Step 0. You can create an individual StepCycle™ procedure for each user. M822 / Ref. 10 743 504 / 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". M822 / Ref. 10 743 504 / Version 01...

  • Page 56: The Maintenance Menu

    • The tilt motor is not moved. • The current user settings are reloaded. • The illumination is switched off. If you move your Leica M822 back down over the operating field, the illumination switches back on and your Leica M822 is ready to use immediately.

  • Page 57: The "How To

    8.33 and objective with WD=200 mm. If you activate the "Standard Values" button, the standard magnification is displayed, regardless of the accessories used. The magnification range is between 7x and 42x. M822 / Ref. 10 743 504 / Version 01...

  • Page 58: Accessories

    Accessories 10 Accessories A comprehensive range of accessories enables the M822 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 59 • 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 M822 / Ref. 10 743 504 / Version 01...
  • Page 60 Accessories Image Component/accessory Description Leica Slit Illuminator Holder for protective glass Protective glass Oculus BIOM Enfocus M822 / Ref. 10 743 504 / Version 01...

  • Page 61: Devices And Accessories Of Leica And Of 3Rd Party Manufacturers

    • Wireless Footswitch, 12 functions 10.2.5 Others • Leica Slit Illuminator • Leica Keratoscope • Leica ToricEyePiece • Leica RUV800 • Oculus BIOM Leica is not responsible for the use of non-approved third party products. M822 / Ref. 10 743 504 / Version 01...

  • Page 62: Care And Maintenance

    Leica Service. We recommend frequent cleaning of the footswitch. 11.2 Cleaning the touch panel Before cleaning the touch panel, switch off your M822 and Cleaning disconnect it from the power supply. If the footswitch is connected to the microscope, unplug it.

  • Page 63: Changing Fuses

    Leica Microsystems service technician only. Unscrew the fuse holder (3) on the underside of the horizontal arm. Remove the fuse (4) from the holder and replace it. Use only 1 A time-lag fuses. M822 / Ref. 10 743 504 / Version 01...

  • Page 64: Notes On Reprocessing Of Resterilizable Products

    Care and maintenance 11.7 Notes on reprocessing of 11.6.3 Coaxial OttoFlex™ illuminator resterilizable products • Use only precision-formed original Leica 12 V/ 50 W halogen bulbs. 11.7.1 General • Never touch the glass bulb of halogen lamps with your bare fingers.
  • Page 65 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. M822 / Ref. 10 743 504 / Version 01...
  • Page 66 Care and maintenance 11.7.3 Sterilization table This list provides an overview of the sterilizable components available at Leica Microsystems (Schweiz) AG, Medical Division for the surgical microscopes. Permissible sterilization methods Steam (autoclave) Ethylene oxide Art. No. Designation 134 °C, t > 10 min.

  • Page 67: Disposal

    Cause 3: Bulb is defective (message "Check Coaxial OttoFlex™ Fault remedy: illuminator"). Check the bulbs and replace any that are defective, see chapter 11.6. Fault: The image goes out of focus. M822 / Ref. 10 743 504 / Version 01...

  • Page 68: Control Unit

    Cause 3: The display is defective. 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. M822 / Ref. 10 743 504 / Version 01...

  • Page 69: Error Messages On The Control Unit

    Contact your leica Microsystems representative. Overheat in opticscarrier. Fault: Fault remedy: Keep the ventilation slots clear. If the problem cannot be fixed, contact your leica Microsystems representative. 13.5 F20 stand Fault: The swing arm moves up/down by itself. Cause 1: The swing arm is not balanced.

  • Page 70: F40 Stand

    Cause 3: Specimen is out of focus. Fault remedy: Focus accurately, insert graticule if necessary. If your instrument has a malfunction that is not described here, please contact your Leica representative. M822 / Ref. 10 743 504 / Version 01...

  • Page 71: Specifications

    Precision-formed halogen bulb, 12 V/50 W Quick-change lamp With two precision-formed halogen mount bulbs, 12 V/50 W (coaxial OttoFlex™ illuminator only) Filter Built-in UV-protection 400 nm M822 / Ref. 10 743 504 / Version 01...

  • Page 72: Electrical Data

    52.0 – 8.7 12.5× Max. permitted ground leakage current for the IEC/EN 60601-1: Leica M822/F40 including secondary device, 5 mA Leica M822/C40 including secondary device, UL 60601-1: Leica M822/F20 including secondary device: 300 µA M822 / Ref. 10 743 504 / Version 01...

  • Page 73: Stands

    10 % to 100 % rel. humidity Balancing via gas spring 500 mbar to 1060 mbar Turning range Axis 1 (at the column): ±170° atmospheric pressure Axis 2 (in the center): +150°/–170° Axis 3 (over XY-unit): ±270° M822 / Ref. 10 743 504 / Version 01...

  • Page 74: Electromagnetic Compatibility (Emc)

    ± 2  kV Line-to-ground 14.12 Limitations of use • Conducted disturbances, induced by RF fields IEC 61000-4-6: The M822 may be used only in closed rooms and must be placed on 10 V rms a solid floor. • Rated Power-frequency Magnetic Field IEC 61000- The M822 is not suitable for crossing thresholds higher than 20 mm.

  • Page 75: List Of Weights Of Balanceable Configurations

    Specifications 14.13 List of weights of balanceable configurations For the Leica Leica M822 F40, drift effects must be taken into account on floors which slant >0.3°. Equipment Leica M822 serial number ............ Max. load for stand from microscope interface ... kg...
  • Page 76 Load of accessories for front/rear section of the eye, sterilizable components, documentation ate sum 2 Intermedi- Carry over load for assistant and optics ate sum 1 Complete Load System This list contains typical equipment articles. Subject to change. M822 / Ref. 10 743 504 / Version 01...

  • Page 77: Dimensional Drawings

    Specifications 14.14 Dimensional drawings 14.14.1 Dimensional drawing (mm) for Leica M822 F20 max. 1480 606 × 606 M822 / Ref. 10 743 504 / Version 01...
  • Page 78 Specifications 14.14.2 Dimensional drawing (mm) for Leica M822 F40 M822 / Ref. 10 743 504 / Version 01...
  • Page 79 Specifications 14.14.3 Dimensional drawing (mm) for Leica M822 C40 M822 / Ref. 10 743 504 / Version 01...

  • Page 80: Annex

    Check the user settings on the control unit for the selected user. Positioning at the OP table Position the M822 on the OP table as required and lock the foot brake (see chapter 8.2). Sterility Fit sterile components and sterile drape if used (see chapter 7.11).
  • Page 81 Annex M822 / Ref. 10 743 504 / Version 01...
  • Page 82 M822 / Ref. 10 743 504 / Version 01...
  • Page 83 M822 / Ref. 10 743 504 / Version 01...
  • Page 84 ISO 9001, ISO 13485, and ISO 14001 relating to quality management, quality assurance and environmental management. 10 743 504en/01 •Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2018• Printed – 05.2018• Subject to modifications • LEICA and the Leica Logo are registered trademarks of Leica Microsystems...

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