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Safety notesXXXXXXThe power cord must have a protective conductor and must beundamaged.Use of accessories and cables other than those specified orprovided by the manufacturer of this equipment could result inincreased electromagnetic emissions or decreasedelectromagnetic immunity of this equipment and result inimproper operation.The Leica M320 surgical microscope may be used only in closedrooms and must be placed on a solid floor.Portable RF communications equipment (including peripheralssuch as antenna cables and external antennas) should be usedno closer than 30 cm (12 inches) to any part of the Leica M320,including cables specified by the manufacturer. Otherwise,degradation of the performance of this equipment could result.Like any other instrument in the operating theater, this systemmay fail. Leica Microsystems (Schweiz) AG thereforerecommends that a backup system be kept available during theoperation.Additional equipment connected to medical electricalequipment must comply with the respective IEC or ISOstandards (e.g. IEC 60950 or IEC 62368 for data processingequipment). Furthermore all configurations shall comply withthe requirements for medical electrical systems (see clause 16of the latest valid version of IEC 60601-1). Anybody connectingadditional equipment to medical electrical equipmentconfigures a medical system and is therefore responsible thatthe system complies with the requirements for medicalelectrical systems. If in doubt, consult your local representativeor the technical service department.3.5User qualificationsThe Leica M320 surgical microscrope may be used only byphysicians and medical assistance personnel with appropriatequalifications who have been instructed in the use of theinstrument. Specific training is not required.3.6XXXXXXXXXXXXXXXDirections for the user of theinstrumentFollow the user Manual.Follow the instructions given by your employer regarding theorganization of work and safety at work.Do not modify the surgical microscope.Danger of tilting of the floor stand! When moving the floorstand, fold up the swing arm as described above and tightenthe articulation brakes.Risk of injury from moving parts! Assemble and balance theaccessories before the operation. Do not install it above thefield of operation.Risk of injury from rolling of the floor stand! Always push themicroscope to move it; never pull it. Do not roll it over anyone’sfeet. Do not roll over cables lying on the floor. Lock the footbrakes during the operation, and never move the device duringoperation.Do not shine lights in anyone’s eyes.Do not switch off/on the surgical microscope during surgery.Do not unplug the system during surgery.Do not cover up the ventilation slot of the optics carrier.Before an extended period of non-use, remove the battery fromthe remote control.To avoid the risk of electric shock, this equipment must only beconnected to a supply mains with protective earth.All parts of the M320 shall not be serviced or maintained whilein use with a patient.Lamps shall not be changed while in use with a patient.Only use the surgery microscope if it is free of defects.NOTEUsing accessories or cables other than those specified here or asapproved by the manufacturer of the Leica M320 surgicalmicroscope can lead to elevated electromagnetic emissions orreduced interference resistance.The Leica M320 surgical microscope may not be used in directproximity of other devices. If it is necessary to operate it in thevicinity of other instruments, the instrument should be monitoredto ensure that it functions properly in this arrangement.M320 Ref. 10734261 / Version 025

Safety notes3.7Dangers of useWARNINGRisk of death from electrical shock!X Connect the microscope to a grounded socket only.WARNINGDanger of injury due to: Uncontrolled lateral movement of the arm system, Tilting of the stand, Trapping of feet in lightweight shoes beneath the casingof the base. Abrupt braking of the surgical microscope at a thresholdthat cannot be crossed.X For transportation, always move the Leica M320 surgicalmicroscope into the transport position.X Never move the stand while the unit is extended.X Never roll the stand or OP equipment over the cableslying on the floor.X Always push the Leica M320 surgical microscope; neverpull it.WARNINGRisk of injury from the binocular tube falling down!X Tighten the clamping screw securely.WARNINGDanger of retinal damage!X Do not shine lights in anyone’s eyes.WARNINGDo not use for ophthalmology.6M320 Ref. 10734261 / Version 02

Signs and labels4Signs and labels31, 8111212, 4, 5, 7,11, 14, 69,101314, 6M320 Ref. 10734261 / Version 027

Signs and labels12Tilting dangerTrained personnel labelOnly to be operatedby trained personnelUtilisation réservée àun personnel formé3Max. load for optics carrier4Type labelLeica Microsystems (Schweiz) AGMax Schmidheiny-Strasse 201CH-9435 HeerbruggMODELLEICA M320 LW12/ TP12/ TC12/ F12100 V - 240 V50 - 60 Hz100 VA2x T6.3 AH 250 VLeica Microsystems (Schweiz) AGMax Schmidheiny-Strasse 201CH-9435 HeerbruggMODELLEICA M320 F12/ W12/ C12/ FP12100 V - 240 V50 - 60 Hz100 VA2x T6.3 AH 250 VMedical device56Mandatory label - read the user manual carefully before operating theproduct. Web address for electronic version of the user manual. 788 UDI Label MET label(only USA and Canada) Presecription device (USA Only)M320 Ref. 10734261 / Version 02

Signs and labels9INMETRO label(only Brazil)OCP 00041011ANVISA Registration number(only Brazil) Grounding label(only USA and Canada) 12System weight label (F12)125 KG13Transport position(F12 floor stand)14Fabrication labelaPrefix numberbLeica system article no.cSerial numberdIncremental number starting at 1 for each batcheJ year (2 digits)fMM month (2 digits)gTT day (2 digits)hProduction starting dateREFSNM320 Ref. 10734261 / Version 029

Design5Design5.1Stands6Table stand with terminal(TC12)7Wall stand (LW12)8Table stand with plate (TP12)To assemble the stand, note the installation instructionsprovided.1Rolling floor stand (F12),long swing armReference model in current usermanual2Rolling floor stand, short swingarm3Wall stand (W12)4Ceiling mount (C12)5Floor stand/baseplate (FP12)10M320 Ref. 10734261 / Version 02

Design5.212Swing arm and horizontal arm5.3Swing arm and horizontal armIntegrated tilt switchMove the swing arm upwards.Light switches offautomatically.Optics carrierCaps for magnification changer are steam- or gassterilizable.1Magnification changer,both sides, increments:6.4, 10, 16, 25, 40 2Illumination control for illumination intensity.3Filter and diaphragm controlsfor white light, orange filterand spot illumination.4Counterweight for balancingwhen many accessories areused.The integrated tilt switch is not available for models TC12,TP12 and LW12.M320 Ref. 10734261 / Version 0211

Design5.4Microscope carrier5.5Two different versions are available.12Brake knobs/articulation brakes1Articulation brake2Lever for locking the verticalposition.3Joint for balancing4Articulation brake5Articulation brake6Tilt brakeInclinedUprightUpright installation is not possible for models TC12, TP12and LW1212M320 Ref. 10734261 / Version 02

Design78Rotary brake(inclined version)5.6Connections1Brake knob for setting the articulation brakes2Main switchArticulation brake(LW12, TP12, TC12)3Power socketM320 Ref. 10734261 / Version 02Port for HDMI/USB cable13

Functions6Functions6.1Illumination6.2With a balanced surgical microscope Leica M320 F12 you can movethe optics in any position without it tilting or falling.The illumination of the surgical microscope M320 consists of 2 LEDs.It is located in the optics carrier.123414Balancing system1Remove the screw.2Remove the side cover.3Remove the screws.4Set the desired position.Four different positions can beset.5Fasten the screws.6Refit the side cover.Switch on the main switch.White LED illumination on theoptics carrier lights up.Illumination control forillumination intensity.Filter and diaphragm controlsfor white light, orange filterand spot illumination.M320 Ref. 10734261 / Version 02

Functions7Fasten the screw.8Turn the lever for locking thevertical position.9Adjust the balancing joint tothe weight using an Allen key(size 8).6.3Footbrakes123Footbrakes are attached to eachof the four wheels on the stand.The wheel is engaged andreleased with the footbrakeengage/release lever (1).X Press the footbrake engage/release lever down (3):X The footbrake is engaged.X Lift the footbrake engage/release lever (2):X The footbrake is released.M320 Ref. 10734261 / Version 0215

Preperation before surgery7Preperation before surgery7.1Transportation6XFold the swing arm together.Tighten the articulationbrake.7XCompare the position of theswing arm with the attachedsign.8XUnplug the power cable.CAUTIONRisk of injury from outward movement of swinging arm!X Do not shine lights in anyone’s eyes.1XPlace swing arm in ahorizontal position.2XTighten the brake knob forlocking the vertical position.3XTurn the optics/microscopecarrier towards the outside.NOTE4XPossible damage of the cable!Always pull the plug, never thecable.Tighten the articulationbrake.9516XOpen the articulation brake.M320 Ref. 10734261 / Version 02XRelease the footbrakes.

Preperation before surgery10XPush the microscope to theinstallation location and position it.CAUTIONRisk of injury to feet!X Always push theinstrument to moveit; never pull it.11XTighten the footbrakes.CAUTIONDanger of microscoperolling away on its own!X Tighten thefootbrakes.M320 Ref. 10734261 / Version 0217

Preperation before surgery7.2Installing the accessoriesCAUTIONRisk of injury from downward movement of the swing arm!X Before installing accessories, tighten the articulationbrakes, see 7.1, "Transportation"7.4Handles7.4.1Installing and removing the front handleNOTEInstall the front handle b efore the rest of the accessoriesGray handle sleeves are steam- or gas-sterilizable.White handle sleeves can be disinfected.Installing the accessories, for example, ErgonOptic Dent.Install any other accessories in a similar manner.1XUnscrew the clampingscrew.1XScrew on the handle sleeveholder.2XPush the accessory into thedovetail interface.2XInsert until the handlesleeve clicks into place.3XTighten the clamping screw.3XPush the knob and releasethe handle sleeve.7.3Documentation outputC-mount port for commerciallyavailable video camera18M320 Ref. 10734261 / Version 02

Preperation before surgery7.4.2127.5Installing the side handlesXXScrew the handle apart.Improves ergonomics at certain working positions: Turningrange 45 with 180 binocular tube.ErgonOptic Dent:Optical extension for morecomfortable work.X For installation, see 7.2,"Installing the accessories".Remove cover with key.7.63XX45XXErgonOptic DentScrew open the bottom holder for the handle.Handle tilt is individually adjustable.ErgoWedgeThe ErgoWedge gives a b inocular with a fixed angle avariable viewing angle of 5 to 25 .1ErgoWedge.2Ideal in combination with 45 inclined binocular tube.X For installation, see 7.2,"Installing the accessories"Refit the handle sleeveholder.Insert until the handlesleeve clicks into place.M320 Ref. 10734261 / Version 0219

Preperation before surgery7.7Objectives7.9Fixed and fine objectives available in various focal lengths.1XInstalling the binocular tubePossible binocular tubes: binocular tube 5 - 25 inclined binocular tube binocular tube 180 , variable straight binocular tube variable binocular tube 30 - 150 inclined binocular tube 45 binocular tube 10 - 50 , type II, Ultra Low IIIRemove the cover from theoptics carrier.NOTE2XScrew in the objective.XFor installation, see 7.2, "Installing the accessories".7.10 Eyepieces37.8XPossible eyepieces: 10 eyepiece, standard (aside from with straight tube12.5 ) 10 eyepiece with crosshair graticule for easier imagecentering 12.5 eyepiece, shows image with similar magnificationto that on the screenTurn the fine focusingobjective for fine focus.1XSet the eyepiece in place.2XTighten the rotary ring.Protective glassThe protective glass is used to protect the objective.The glass is steam- or gas-sterilizable.1Fine focusing objective:The nose points forward.2Fixed objective:The nose points 90 towardsthe left or right.20M320 Ref. 10734261 / Version 02

Preperation before surgery7.11 Adapters7.12 Positioning at the operating tableNOTE7.12.1 Positioning optionsThe microscope is not balanced.X To prevent it from tipping over, tighten the a rticulation brakes.1XInstall the stereo adapter.XX2XFit the beam splitter.For 50/50 % or 70/30 %observation.3XInstall the stereoattachment for secondobserver on the left side.4XFit the binocular tubes.5XTurn the white ring to alignthe cutout for the assistant.Carefully move the surgical microscope at the column to theoperating table and position it for the forth coming operation.Tighten the footbrakes.NOTEXFor installation, see 7.2, "Installing the accessories".M320 Ref. 10734261 / Version 0221

Preperation before surgery7.13 Mounting sterile components7.14 Installing the drapeCAUTIONCAUTIONDanger of infection!X Avoid touching the sterile components.X Allow sufficient free space.Do not install the sterile components until shortlybefore the operation.Handle sleeves and caps for the magnification changer aresteam and gas-sterilizable.X Sterilize the handle sleeves and caps after use.Danger of overheating!X Do not wrap the drapearound the microscopetoo tightly. Thedistance between themicroscope and drapeshould be 20 cm.X1XInsert until the handlesleeve clicks into place.7.15 Balancing the swing armFor general preparation see chapter 6.2, "Balancing system". Alsocheck the movement of the swing arm before positioning themicroscope over the patient.7.16 Adjusting the interpupillarydistance2XAttach the caps.3XAttach protective glass onobjective. The noise pointsforwards (fine focusobjectives) or 90 to theleft/right (fixed objectives).X7.17 Checking the illuminationXXX22Look into the eyepieces.Depending on the model,move the tube manually orusing the drive knob until acircular field is visible.Turn the rotary knob fromzero to maximum brightness.For the general preparation see chapter 6.1,"Illumination".Also check the brightness and filters before positioningthe microscope above the patient.M320 Ref. 10734261 / Version 02

Preperation before surgery7.18 Changing the accessories of thesurgical microscope andbalancing the swing arm7.19 Adjusting the parfocality withcamera and monitorParfocal means that the sharpness remains constant overthe entire magnification range.X Adjust the diopter settings for both eyes separately andaccurately.WARNINGRisk of injury!X Before re-equipping always lock the swing arm.XWhen changing accessories ensure to balance the swingarm again.1XPlace a piece of paper withwriting on it under the objective.2XMaximum magnification(40 ).3XBring the writing on thesheet of paper into sharpfocus on the monitor.4XWithout looking into theeyepieces, set the minimummagnification (6.4 ).The image on the monitormust remain sharp!5XTurn the dioptric correctionon the eyepieces to " 5".M320 Ref. 10734261 / Version 0223

Preperation before surgery678XXXLook into the eyepieces.Rotate each eyepieceindividually clockwise, inthe "–5" direction, untileach eye sees the writing insharp focus.Set maximummagnification(40 ).7.20 Adjusting the parfocality withoutcamera and monitorParfocal means that the sharpness remains constant overthe entire magnification range.X Adjust the diopter settings for both eyes separately andaccurately.Personal diopeter setting known:XSet dioptric correction oneyepieces.Bring the writing on thesheet into focus.Personal diopeter setting unknown:9X1XAdjust the dioptric settingat the eyepiece to 0.2XPlace a piece of paper withwriting on it under the objective.3XSet maximum magnification(40 ).4XBring the writing on thesheet of paper into focus.Turn out the eyecups to thedesired distance.The writing should now remain sharp when you change themagnification.X If it does not, repeat the p rocedure.24M320 Ref. 10734261 / Version 02

Preperation before surgery567XXXWithout looking into the eyepieces, set the minimummagnification (6.4 ).7.21 Check the remote control andcameraXPress on the remote controlor on the video camera tocapture still images.A signal tone sounds.XPress on the remote controlor on the video camera toinitiate video recordings.A signal tone sounds.XTo end the video recording,press on the remote controlor on the video camera.A signal tone sounds.Turn the dioptric correctionon the eyepieces to " 5".Look into the eyepieces.Rotate each eyepieceindividually clockwise, inthe "–5" direction, untileach eye sees the writing insharp focus.8XSet maximum magnification(40 ).9XTurn out the eyecups to thedesired distance.The writing should now remain sharp when you change themagnification.X If it does not, repeat the p rocedure.M320 Ref. 10734261 / Version 0225

Preperation before surgery7.22 Checklist before surgeryX 26Ensure the following prior to positioning the surgicalmicroscope above the patient.Footbrakes tightenedProper fixation of all parts and accessoriesProper positioning at the operating tableSterile components and drape installedIllumination working properlyRemote control and camera working properlyM320 Ref. 10734261 / Version 02

Operation8Operation8.1Starting up4XScrew in the cover of thehorizontal arm and tightenit.5XConnect the HDMI cable toa suitable monitor orscreen.6XConnect the USB cable(optional) to the computer.7XConnect the power cable.8XSwitch on the main switch.9XWhite LED illumination onthe optics carrier lights up.WARNINGRisk of death from electric shock!X Connect the microscope to a grounded socket only.CAUTIONAdditional equipment connected to medical electricalequipment must comply with the respective IEC or ISOstandards (e.g. IEC 60950 or IEC62368 for data processingequipment).The length of the HDMI cable must not exceed 10 m.X Use only high-quality HDMI cables.HDMI cables are available from Leica.Use only monitors approved for medical purposes orequipped with an isolating transformer. Isolatingtransformers are available from Leica.1XRemove cover of the horizontal arm.2XPlug the power cable intothe horizontal arm andfasten it using cable ties.3XPlug the HDMI cable andUSB cable (optional) intothe horizontal arm andfasten it using cable ties.M320 Ref. 10734261 / Version 0227

Operation8.2Adjusting the design LEDilluminator8.3Adjusting the working distance1XCoarse focus by raising andlowering the microscope.2XFine focus via optional fine focusing objective.There are five different dimming levels.12XXSwitch on the main switch.Remove cover of horizontalarm.XIf the fine focus objective fails, adjust the focusmanually by moving the optics carrier up and down.NOTE3XUsing a ball-point pen orsimilar object, press theswitch until the desireddimming level is reached.4XScrew in the cover of thehorizontal arm and tightenit.28Manual emergency functions are available for focus.X Brakes could be overcome with muscle power.M320 Ref. 10734261 / Version 02

Operation8.41Adjusting the illumination8.5Re-equipping during operationWARNINGWARNINGDanger of retinal damage!X Do not shine lights in anyone's eyes.XXBefore re-equipping during the operation, first swingthe microscope away from the operating field and lockthe swing arm.Set the desired illuminance.WARNINGX2XSelect the desired filter or diaphragm function:White lightOrange filterSpot illuminationIn case of an illumination cooling fan failure an acousticalarm appears (short beep every 5 seconds, lasting for5 minutes).After re-equipping, always re-balance the microscopeon the swing arm.In case of a thermistor on the 2 LED array reaches 85 C anacoustic alarm appears (2 short beeps every 5 seconds) andafter 5 minutes of alarm the main illumination of the

The Leica M320 surgical microscope is state-of-the-art technology. Nevertheless, hazards can arise during operation. Always follow the instructions in this user manual, and in particular the safety notes. 3.1 Intended use The Leica M320 surgical microscope is an optical instrument