Zeiss OPMI Lumera i Instructions For Use Manual Download Page 152

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Device data

OPMI Lumera i

Version 8.0

Page 152

G-30-1720-en

Integration of the device in an IT network which includes other ME
devices may lead to risks for patients, operators, or other persons that
were not previously known.

–

The operator of the device must determine, analyze, evaluate, and control
these risks before the device is connected to the IT network.

–

The following changes to the IT network could introduce new risks, and
therefore require additional analysis:

–

Changes to the IT network configuration

–

Changes to additional elements in the IT network

–

Removing elements from the IT network

–

Updates to devices that are connected to the IT network

–

Upgrades of devices that are connected to the IT network

Summary of Contents for OPMI Lumera i

Page 1: ...ZEISS OPMI Lumera i on the floor stand Instructions for Use G 30 1720 en Version 8 0 2018 11 26...

Page 2: ...apply to the OPMI Lumera i with the following identification Reference number 6633 Software Release 1 5 Trademark OPMI OPMI Lumera Inverter tube CALLISTO eye HaMode SCI Stereo Coaxial Illumination Min...

Page 3: ...ry of the section Section Safety measures 5 Section Device overview 33 Section Preparation for use 59 Section Operation 89 Section What to do in the event of malfunctions 129 Section Care and maintena...

Page 4: ...OPMI Lumera i Version 8 0 Page 4 G 30 1720 en...

Page 5: ...r 9 Requirements to be met by the user 12 Liability and warranty 12 Requirements for operation 14 Before every use 14 During use 15 After every use 15 Measures to prevent phototoxic injury 16 Illumina...

Page 6: ...s OPMI Lumera i Version 8 0 Page 6 G 30 1720 en Switch for manual mode 24 Locking lever for limiting vertical movement 26 Position of the microscope with fundus imaging system 26 Symbols and labels on...

Page 7: ...for Use Please note this information and be particularly careful in these cases Information symbols The following information symbols are used in these Instructions for Use Lists Requirements for an...

Page 8: ...ese instructions for use They will be performed by staff specially trained for this purpose by ZEISS Field of use Intended use OPMI Lumera i is a surgical microscope intended for the illumination and...

Page 9: ...bels attached to the system See Page 28 Legal regulations Check regularly that the legal regulations applicable in your country with regard to accident prevention and work safety are being complied wi...

Page 10: ...f time or if you want to clean its surface Switch off the system at the power switch if you notice any smoke sparks or unusual noise Do not use the unit until it has been repaired by the ZEISS Service...

Page 11: ...the regular technical safety checks defined for this system are performed on schedule and to the stipulated extent The technical safety checks must only be performed by the manufacturer ZEISS or perso...

Page 12: ...ng non Zeiss equipment make sure that sufficient free space is available for focus positioning Requirements to be met by the user The device may be operated only by personnel who are properly instruct...

Page 13: ...ave not been calibrated the visualized video sequences video clips and single images may include deviations in scale color and shape Transmission to other monitors in particular may change the display...

Page 14: ...d has been plugged into a power outlet which is properly grounded The device is connected with the power cord supplied Before every use Make sure that all function tests before use are performed and t...

Page 15: ...posure time to the absolute minimum required Phototoxic effect of light beams When operating on the eye always use the retina protection filter blue barrier filter installed in the light source and or...

Page 16: ...xposing the eye to light with varying spectral compositions have been conducted since as early as the 1950s These studies suggest that the potential hazard of phototoxic injury to the patient s retina...

Page 17: ...to the conditions existing in each case Angle of illumination Several publications1 4 suggest tilting the microscope to reduce the exposure of the macula to direct illumination Tilting mechanism The s...

Page 18: ...o 100 The stipulations of standard DIN EN ISO 15004 2 2007 result in maximum radiation exposure times for the different illumination configurations as specified in the table Maximum radiation exposure...

Page 19: ...e position of the eye usually not the macula directly For cataract procedures ZEISS recommends adjusting the surrounding field illumination to be somewhat darker than the central red reflex spot Not o...

Page 20: ...of 10 has been used in determining these limits The use of the blue barrier filter increases the recommended exposure time by a factor of 3 compared with the values specified below Maximum radiation e...

Page 21: ...Pollack Microscope induced retinal phototoxicity in cataract surgery of short duration Ophthalmology 109 334 338 2002 5 DIN EN ISO 15004 2 2007 Optical instruments Fundamental requirements and test m...

Page 22: ...e the backup lamp Filter wheel for the protection filter 2 Filter selector knob for swiveling the protection filter The filter selector knob has four positions No filter Retina protection filter blue...

Page 23: ...Version 8 0 G 30 1720 en Page 23 OPMI Lumera i Safety measures Fig 1 Button for backup lamp and knob for protection filter 1 2...

Page 24: ...completion of the application The 5 7 control panel is black To be able to continue surgery Manually set the magnification on the microscope s zoom adjustment knob 3 1 e g with the help of a coin Man...

Page 25: ...Version 8 0 G 30 1720 en Page 25 OPMI Lumera i Safety measures Fig 2 Switch for manual mode 3 1 3...

Page 26: ...ified by ZEISS for combination with the surgical microscope described in this manual WARNING Injury to the patient s eye Incorrect operation of the fundus imaging system may cause injury to the patien...

Page 27: ...Version 8 0 G 30 1720 en Page 27 OPMI Lumera i Safety measures Fig 3 Locking lever for limiting vertical movement 4...

Page 28: ...tween the two arrow tips the focusing system of the surgical microscope is in its initial position Light guide mount This label shows how to correctly connect the light guide Device name This imprint...

Page 29: ...med after all accessories have been mounted on the microscope Radio label FCP Gateway WL optional This device complies with Section 15 of the FCC Rules USA and the RS 210 standard Canada Operation is...

Page 30: ...mera i Rated voltage 115 V 100 125 V 230 V 220 240 V Connected load 115 V max 950 VA 230 V max 950 VA Line frequency range 50 60 Hz Maximum total weight with installed safe workload max 190 kg CSA app...

Page 31: ...rer i e phone number fax number and e mail address of the local contact of the national ZEISS sales organization SIP number A unique identification number assigned to your system Observe transport pos...

Page 32: ...Safety measures OPMI Lumera i Version 8 0 Page 32 G 30 1720 en...

Page 33: ...s 43 Components on the suspension system 44 Control elements on the suspension arm 45 Controls on the carrier arm stand column stand base 46 Controls on the lamp housing 47 Connector panel on the floo...

Page 34: ...ed or brought into its standby position suspension arm in upward position The light turns off in the standby position and functions like XY or Focus Reset are reset to their stored start value The dow...

Page 35: ...Version 8 0 G 30 1720 en Page 35 OPMI Lumera i Device overview Fig 4 System overview 3 1 2...

Page 36: ...integrated Stereo Coaxial Illumination SCI for illuminating the surgical field SCI has been specially designed for the requirements of ophthalmic applications and comprises red reflex and surrounding...

Page 37: ...Version 8 0 G 30 1720 en Page 37 OPMI Lumera i Device overview Fig 5 Components of the microscope 2 2 1 4 3...

Page 38: ...ng to generate an optimum red reflex Glare from the sclera is greatly reduced as only the central field of view is illuminated Position 2 Red reflex with surrounding field illumination This setting pe...

Page 39: ...Version 8 0 G 30 1720 en Page 39 OPMI Lumera i Device overview Fig 6 Controls on the microscope 2 3 4 1...

Page 40: ...e XY reset Focus reset always active Zoom Reset The initial value for the zoom system can be defined via the 5 7 control panel see Page 108 Light Reset The initial value for light intensity can be def...

Page 41: ...Version 8 0 G 30 1720 en Page 41 OPMI Lumera i Device overview Fig 7 Controls on the microscope 9 7 6 5 7 11 10 8 9...

Page 42: ...en reached when the two eyepiece images merge into one You can read off the PD setting on the adjustment knob Inverter tube 110 tilting tube 3 Eyepiece mounting 4 Eye distance adjustment wheel interpu...

Page 43: ...NOTE Widefield eyepieces with magnetic coupling When handling eyepieces that have been removed from the tube please keep in mind the usual rules for handling magnets Do not place the eyepiece near ins...

Page 44: ...d the surgical microscope is located in the park position In this position the light turns off and the OPMI is reset to the user specific start values e g XY or focus reset see Page 122 2 Support arm...

Page 45: ...ovement for setting the lower limit position see Page 80 3 Friction adjustment knob for rotation of the surgical microscope for adjusting the friction of the axis of rotation of the surgical microscop...

Page 46: ...panel 2 Friction adjustment knob for the suspension arm s swivel movement 3 Friction adjustment knob for the carrier arm s swivel movement 4 Cable clip 5 Locking tab for casters 6 Steerable caster 7...

Page 47: ...ng the operating status of the halogen lamps When the flap is closed the main lamp is operative When the flap is open yellow mark on the side the backup lamp is in use 3 Manual switching to the backup...

Page 48: ...the installation site You can adjust the sliding switch using a suitable tool 8 Power inlet socket CAUTION Connection to data networks Use the LAN port only in combination with galvanic network isola...

Page 49: ...Version 8 0 G 30 1720 en Page 49 OPMI Lumera i Device overview Fig 14 Connectors on the floor stand 1 6 2 5 7 8 3 4...

Page 50: ...for brightness and color signals This standard provides good image quality if the video signal is transmitted over short distances up to 10 m Use the BNC port for longer distances 12 Video output BNC...

Page 51: ...Version 8 0 G 30 1720 en Page 51 OPMI Lumera i Device overview Fig 15 Connectors on the floor stand 9 10 11 12...

Page 52: ...m light source and camera if provided and the programmable buttons on the foot control panel 2 Switch for manual mode for manual control of the major functions in the event of system failure see Page...

Page 53: ...ordering data Foot control panel with 14 functions wireless FCP WL Foot control panel with 14 functions wired FCP 3 m optional Foot control panel with 14 functions wired FCP 6 m optional Set up 1 Conn...

Page 54: ...light source on off Button F light source on off Joystick The joystick located between buttons C and D is used to control the X Y coupling Rocker switches The default settings focus zoom of the rocke...

Page 55: ...nfigure the video cameras via the 5 7 control panel Connection via video objective lenses VOL 442 802 1 VOL 442 video objective lens featuring three optical output ports 2x co observation 1x camera bl...

Page 56: ...C mount adapter for beam splitter video camera connection 3 3 CCD video camera 4 Beam splitter with two optical output ports to which e g a co observation module or a video camera with C mount adapte...

Page 57: ...age of the surgical field The following configurable data can be injected in EDIS TIOL data angle target axis Video recording On Off Assistant functions Incision LRI Rhexis ZALIGN You will find additi...

Page 58: ...vice overview OPMI Lumera i Version 8 0 Page 58 G 30 1720 en 1Chip HD camera option 1 1Chip HD camera option flanged to a beam splitter 2 CCU Camera Control Unit Control unit for the 1Chip HD camera 1...

Page 59: ...74 Installing the 1Chip HD camera 74 Cable connections for the 1Chip HD camera 75 Connecting the system and accessories 76 Connecting the suspension system to line power 76 Connecting the foot control...

Page 60: ...y over the requirements of the above mentioned standards If you have any questions contact your local dealer or ZEISS Service WARNING Risk of serious injury due to unauthorized modification You must n...

Page 61: ...Version 8 0 G 30 1720 en Page 61 OPMI Lumera i Preparation for use...

Page 62: ...ding on even ground CAUTION Risk of crushing mind your fingers Fingers may be crushed in the areas marked with the Risk of crushing label Do not touch these areas while the system is being moved or br...

Page 63: ...by itself Because the stand moves so smoothly it is easy to underestimate how heavy it is Therefore move the stand slowly and carefully NOTE Transport over long distances The device may be transported...

Page 64: ...s manual Never exceed the maximum permissible weight capacity of the suspension arm see Page 148 Rebalance the suspension arm after every change of equipment see Page 73 Tighten all friction knobs fir...

Page 65: ...necessary to apply some force Insert the new widefield eyepieces 7 as far as they will go in the mounts 6 intended for them The magnetic coupling reliably secures them in position Unscrew the objecti...

Page 66: ...ve lens Connection via a beam splitter and C mount adapter see Page 70 Mount the beam splitter and C mount adapter WARNING Risk of injury caused by accessories falling down Never mount or remove any a...

Page 67: ...objective lens VOL 802 Loosen locking screw 4 on video objective lens 5 by a few turns Insert camera block 1 into video objective lens 5 in the direction of the arrow as far as it will go Firmly tigh...

Page 68: ...or video objective lens VOL 802 Unscrew securing screw 4 by a few turns Attach video objective lens 3 to surgical microscope 6 Locating screw 5 must fit into the corresponding groove on video objectiv...

Page 69: ...used for other accessories e g camera adapter Loosen knurled ring 1 on the video objective lens An arrow with the labeling open is located on the shaft next to knurled ring 1 Remove dust cover 2 and...

Page 70: ...unt Make sure that the locating block is fed into the counterpart of knurled ring 4 Screw knurled ring 4 onto C mount video objective lens 2 Firmly tighten knurled ring 4 Screw the camera head onto C...

Page 71: ...Version 8 0 G 30 1720 en Page 71 OPMI Lumera i Preparation for use Fig 24 C mount adapter 3 7 4 2 1 5 8 6...

Page 72: ...mination system Insert the correct end of the light guide into light guide socket 2 of the surgical microscope as far as it will go Always make sure before surgery that both the primary lamp and backu...

Page 73: ...t the spring force is sufficient to compensate for the weight of the surgical microscope and accessories Turn clockwise to increase the spring force turn counterclockwise to reduce it Continue to perf...

Page 74: ...er with the 1Chip HD camera remains installed on the surgical microscope However the beam splitter with the 1Chip HD camera can be removed from the surgical microscope if necessary CAUTION Risk of inf...

Page 75: ...shock if the video output ports are touched When configuring your system comply with the requirements of IEC 60601 1 IEC 60601 1 1 is still valid in some countries CAUTION Risk of tripping over cable...

Page 76: ...ated voltage available on the site of installation otherwise the suspension system will be damaged If the rated voltage has not been correctly set adjust the sliding switch in indicator window 5 using...

Page 77: ...the device has been switched on the green lamp in the switch is lit Secure the FCP cable with the strain relief device see Page 78 Connect the FCP cable to the connector 2 on the stand Fig 27 Connecti...

Page 78: ...t the remaining cable length between the strain relief device and the connector on the connector panel is approx 320 mm Secure the cable in the strain relief device as follows Form a loop with the cab...

Page 79: ...Video output RGB Fig 29 Connecting video devices CAUTION Risk of electric shock caused by unapproved or defective accessories R506 Unapproved or defective accessories can cause increased leakage curre...

Page 80: ...e between the microscope and the surgical field The limit of downward travel is only effective in the lower part of the suspension arm s vertical movement range starting from the arm s horizontal posi...

Page 81: ...nvenient for you such as that shown below Make sure that carrier arm 2 and suspension arm 4 are not fully extended but are positioned at an angle This provides a greater degree of maneuverability and...

Page 82: ...ersion 8 0 Page 82 G 30 1720 en Tilt adjustment motion Tilt the microscope to the required position The optical axis of the microscope should generally be positioned at right angles to the patient s e...

Page 83: ...Version 8 0 G 30 1720 en Page 83 OPMI Lumera i Preparation for use...

Page 84: ...different users so that they can be easily preset during system preparation Adjusting the interpupillary distance Set the minimum magnification on the main microscope using the foot control panel Posi...

Page 85: ...seen Adjusting magnification Set the maximum magnification on the main microscope using the foot control panel Focus on the object Set the required magnification using the foot control panel The focal...

Page 86: ...enclosed Preparation of resterilizable products manual for each Asepsis Set For the OPMI Lumera i the following asepsis caps are available see Page 170 for ordering data 1 Asepsis cap for interpupill...

Page 87: ...hen draping the system make sure there is enough slack in the drapes to allow for movement of the microscope carrier and surgical microscope CAUTION Reduced image quality Drapes with vision guard may...

Page 88: ...Preparation for use OPMI Lumera i Version 8 0 Page 88 G 30 1720 en...

Page 89: ...ng the language 104 Deleting users 104 Light source 105 Switching the light source on off 105 Setting the starting values of the light source 107 Adjusting magnification 108 Setting the start value of...

Page 90: ...djusting video mode 113 White balancing 119 Performing the black balance procedure 120 System settings 121 Configuring XY reset button 121 Configuring standby position 122 Setting speeds 123 Setting p...

Page 91: ...witching on the surgical microscope for the fist time displays the default user profile Default User In the next logins the system displays the last user selected The Default User profile can be neith...

Page 92: ...r switch is no longer illuminated The current of the power outlet socket cannot be switched off by the power switch CAUTION Never leave the device unattended when it is switched on If a patient or an...

Page 93: ...eck the unobstructed movement of the surgical microscope The ease of movement has been adjusted using the friction adjustment knob on the suspension system see Page 45 All cables and accessories have...

Page 94: ...er functions according to the respective instruction manuals Check correct balancing When fully balanced the surgical microscope should remain stationary in all positions within the work area and move...

Page 95: ...The system has been positioned in such a way that it can be moved away from the patient at any time Check foot control panel Suspension system and surgical microscope must perform the specified funct...

Page 96: ...rect operation of the fundus imaging system may cause injury to the patient s eye and impair image quality Perform the following steps to avoid this hazard Perform a focus reset With the fundus viewin...

Page 97: ...Version 8 0 G 30 1720 en Page 97 OPMI Lumera i Operation...

Page 98: ...enu option is not selectable the associated button is grayed out The menu name displayed at the bottom right of the screen 8 indicates where in the menu you currently are 1 Main menu 2 User submenu se...

Page 99: ...Version 8 0 G 30 1720 en Page 99 OPMI Lumera i Operation Fig 35 Menu structure 2 3 7 6 5 4 1 8...

Page 100: ...changes have been made Grayed out button no changes have been made Changing the range of values The arrow buttons permit you to increase or reduce the numerical values of functions e g light intensit...

Page 101: ...tered in the entry box The length of the name is limited to 20 characters The following entry options are provided 1 Text field The entered text is displayed here 2 ABC keypad You can use these keys t...

Page 102: ...button to save the user A data acceptance menu is displayed Tap on the button Yes in order to assign the current user data to the new user Touch the button No to assign only default data to the user T...

Page 103: ...user from the user list Press the button to load the user A data acceptance menu is displayed The user specific language is set The User menu is displayed again Change user name Press the User button...

Page 104: ...ress the button to save the change A data acceptance note is displayed The language setting is changed The main menu is displayed again Deleting users Press the User button in the main menu The User m...

Page 105: ...Off button The light source is on when the button is highlighted in dark blue color CAUTION Damage to the eye caused by high light intensity Too much light intensity brightness or excessive radiation...

Page 106: ...If a different user logs on the current status of the light source is retained When the system is rebooted the light source is reset to its Light off default status To save the changes press the butt...

Page 107: ...n if the function is activated see Page 121 Moving the system into its standby position if the function is activated see Page 122 Press the Light button in the main menu The Light menu is displayed Ad...

Page 108: ...ching the device on Pressing the reset button if the function is activated see Page 121 Moving the system into its standby position if the function is activated see Page 122 Press the Magnification bu...

Page 109: ...s need to be readjusted accordingly Zoom focus link This function permits the focusing speed to be coupled with the current zoom value to facilitate the focusing on object details The preselected focu...

Page 110: ...signed to meet the user s specific requirements The factory settings are Button A light intensity Button B light intensity Button C video mode selection e g anterior or posterior Button D selection of...

Page 111: ...hange A list of the selectable functions is displayed If several selectable functions are available a scroll bar is displayed Use the arrow buttons to scroll up and down Tap the function to be assigne...

Page 112: ...des permit you to assign camera settings specially preconfigured for medical applications to the user profile Press the Video button in the main menu The Video menu is displayed Press the button requi...

Page 113: ...he submenu of the selected video mode is displayed Selecting the exposure mode You can set the exposure mode in the Brightness field Manual exposure Press the Manual Brightness button Manual exposure...

Page 114: ...ocated at the image center the Small Spot setting usually does not provide the desired exposure result In this case select either a larger area integral or large or use the manual exposure mode Select...

Page 115: ...int the surgical microscope at a white object e g a piece of white paper with a matte surface Switch on all light sources required Swing the yellow filter in or out Focus on the object Press the Conti...

Page 116: ...le These modes permit you to assign camera settings specially preconfigured for medical applications to the user profile Press the Video button in the main menu The Video menu is displayed Press the b...

Page 117: ...t the color saturation color intensity and purity of the video image Move the slider to the required color value The colour value of the video image can be infinitely adjusted between 0 and 100 Genera...

Page 118: ...ea in the image center This metering pattern is suitable for working with an extremely small illuminated field diameter However if the object of interest is not located at the image center the Small S...

Page 119: ...microscope at a white object e g a piece of white paper with a matte surface Switch on all light sources required Swing the yellow filter in or out Focus on the object Press the Continue button The f...

Page 120: ...cover the objective lens and the eyepieces Then press Continue Switch off all light sources of the system Cover the objective lens so that no light can enter Press the Continue button The display sho...

Page 121: ...ues when XY reset button 1 is pressed The settings are saved for the specific user Select System Settings XY Reset in the main menu The submenu XY Reset is displayed CAUTION Risk of collision Pressing...

Page 122: ...ayed again Configuring standby position The standby position is reached when suspension arm 1 is moved to the topmost position This automatically deactivates the light source The functions are reset t...

Page 123: ...utton in the main menu The System Settings menu is displayed Press the Speeds button The Speeds menu is displayed It includes the following functions Focus speed Press the button to increase the focus...

Page 124: ...ion submenu permits you to check the software currently installed in your system Select System Settings System Options Version in the main menu The Version menu is displayed It contains information on...

Page 125: ...el color Successful pairing If pairing was successful the Radio link intensity status indicator 1 flashes green for approx 1 s and the following message appears Pairing successfully completed Put the...

Page 126: ...in the patient s eye Adjust the illumination intensity and the resulting radiation exposure time by selecting the appropriate illumination setting You will find the values recommended by ZEISS in the...

Page 127: ...anterior eye segment To prevent contact with the patient ensure that the range of movement is sufficient for the position of the focus WARNING Risk of injury due to vertical movement of the suspensio...

Page 128: ...retinal injury in the patient s eye Never leave a device unattended when its light source is switched on NOTE Restricted functions due to malfunctioning motor electronics If the motor electronics mal...

Page 129: ...s What to do in the event of malfunctions Failure of the halogen light source 130 Failure of a main function XY fcs zom light 131 Troubleshooting 132 For your safety 132 Faults in the system 132 Malfu...

Page 130: ...s defective the backup lamp can also be swiveled in manually Press button 3 to manually swivel the backup lamp into the beam path Exchange the defective lamp at the first opportunity see Page 140 If t...

Page 131: ...the manual mode to complete a surgical procedure that has already been started Press the button 1 to switch to manual mode Working in manual mode In manual mode the light source is set to a medium in...

Page 132: ...at to do in the event of malfunctions attach a sign Out of order to the system and contact a ZEISS service representative Faults in the system Fault Possible reason Corrective measure Cross reference...

Page 133: ...nation Brightness level set too low Adjust brightness on suspension system or foot control panel Page 105 Aging of the lamp can reduce the amount of light Replace lamp Page 140 Defective light guide i...

Page 134: ...cal axis of patient s eye Page 121 Image on video monitor too dark or high level of noise Use of a camera adapter Remove fixed stop from camera adapter Instructions for Use for camera Activate the int...

Page 135: ...he following website www meditec zeiss com Fault Possible reason Corrective measure Cross reference Foot control panel is inoperative Connections on suspension system or foot control panel not plugged...

Page 136: ...e e g jammed motor of the focus system If the error impairs your work switch to the manual mode Page 131 Error during system start Please reboot the system making sure that no function buttons are pre...

Page 137: ...aintenance Care and maintenance Device maintenance 138 Maintenance intervals 138 Safety check 139 Changing the halogen lamp 140 Care of the device 142 Cleaning 142 Sterilization 143 Disinfection 143 E...

Page 138: ...ce activities that you are able to perform yourself are described below Any other maintenance activities that is not described here in detail requires device specific knowledge Please contact your loc...

Page 139: ...f the Instructions for Use Visual inspection of the device and accessories for damage as well as legibility of the labels Leakage current test Test of protective ground conductor Function and wear tes...

Page 140: ...interior of the reflector 6 Press the halogen lamp into the spring loaded mount 4 5 Push the lamp module including the new halogen lamp back into the device Turn on the device at the power switch 3 In...

Page 141: ...ion 8 0 G 30 1720 en Page 141 OPMI Lumera i Care and maintenance Always make sure before surgery that both the primary lamp and backup lamp are intact Fig 38 Changing the halogen lamp 6 7 5 8 4 9 10 1...

Page 142: ...ower or a clean grease free brush For regular cleaning of the surgical microscope s objective lenses and eyepieces we recommend using the optics cleaning kit available from ZEISS For the catalog numbe...

Page 143: ...o move Do not cover the ventilation slots in order to ensure that the lamps are able to cool sufficiently and to avoid any loss in lamp functionality Disinfection It may be necessary to disinfect the...

Page 144: ...our local dealer or the device manufacturer or its legal successor Please also consult the manufacturer s current information provided on the Internet In the event of resale of the product or its comp...

Page 145: ...ufacturer s declaration concerning electromagnetic compatibility 156 EMC Electromagnetic compatibility IEC 60601 1 2 2014 4th edition 158 Electromagnetic interference 158 Electromagnetic immunity for...

Page 146: ...ed by the manufacturer were tested The following device functions have been defined for the immunity test Visualization of the object must be maintained minor image distortions are permitted The light...

Page 147: ...he XY reset button the focusing drive moves to the starting position of the focusing range Focal length of objective lens f 200 mm f 175 mm option f 225 mm with support ring option Tubes Eyepieces 180...

Page 148: ...e Approx 8 5 kg without tube objective lens and eyepieces Suspension arm Length 750 mm Swivel angle 290 Lifting range 400 mm 320 mm Support arm Length 450 mm Swivel angle 360 Stand height 1730 mm Base...

Page 149: ...Version 8 0 G 30 1720 en Page 149 OPMI Lumera i Device data Fig 39 Dimensional drawing of OPMI Lumera i...

Page 150: ...ains power plug 115 230 V max 500 VA Video output port RGB Video output port Y C Video output BNC Remote socket for an external signal with max 24 V 0 5 A Ethernet connection optional Fiber optic illu...

Page 151: ...work connection with the device The IT network has an Ethernet connection via RJ45 at least Cat 5 100 Mbit s The device has a network isolator in compliance with IEC 60601 1 which means it is not conn...

Page 152: ...ust determine analyze evaluate and control these risks before the device is connected to the IT network The following changes to the IT network could introduce new risks and therefore require addition...

Page 153: ...ning system 2 1 interlace 625 lines 50 fields second 25 frames second Analog video output ports VBS 1 0 Vp p 75 PAL composite Y C 1 0 Vp p 75 luminance 0 3 Vp p 75 chroma Component Feature Image senso...

Page 154: ...ace scan CCD image sensors Horizontal resolution 800 lines Vertical resolution In accordance with PAL standard Signal to noise ratio 62 dB Scanning system Interlace 50 half frames second Analog video...

Page 155: ...l resolution 800 lines Vertical resolution In accordance with NTSC standard Signal to noise ratio 62 dB Scanning system Interlace 60 half frames second Analog video output ports VBS 1 0 Vp p 75 PAL co...

Page 156: ...rate the OPMI Lumera i in close proximity to other devices with the exception of the combination of the devices described in these Instructions for Use as this can impair the functioning of the OPMI L...

Page 157: ...tial risk for the proper functioning of medical equipment Malfunctions may be caused by a variety of local factors Such malfunctions cannot be predicted or assessed in advance Please follow the EMC gu...

Page 158: ...ctromagnetic environment as specified below The customer or the user of the OPMI Lumera i is responsible for ensuring that the device is operated in such an environment Emitted interference measuremen...

Page 159: ...immunity as per IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines 1 kV for input output lines 1 kV for input output lines Surges as per IEC 61000 4 5 0 5 kV 1 kV phase neutral vol...

Page 160: ...in such an environment Electromagnetic immunity tests IEC 60601 test level Compliance level Conducted HF disturbances as per IEC 61000 4 6 3 V 150 kHz to 80 MHz 3 V 6 V ISM bands between 150 kHz and 8...

Page 161: ...ultiple electrical outlets Only connect compatible components to the system Do not exceed the max permissible electrical load of multiple electrical outlets Use multiple electrical outlets only for co...

Page 162: ...er components for the respective function are evident from the descriptive text For this reason you should also cite the descriptive text in any orders Ordering data for OPMI Lumera i surgical microsc...

Page 163: ...1023 188 Description Order no 180 tiltable tube 303791 0000 000 Inclined tube with 45 viewing angle option 303784 0000 000 Inverter tube option 303797 9120 000 Description Order number Objective lens...

Page 164: ...pivot joints 000000 1063 869 Inverter tube 303797 9120 000 Widefield push in eyepiece 10x 305542 0000 000 Stereo co observation module complete with inclined tube and 12 5x eyepieces Stereo co observa...

Page 165: ...gnification changer 303429 9903 000 Inclined binocular tube f 170 mm 45 303784 0000 000 Sleeve for tubes with screw thread 305542 0107 000 12 5x push in widefield eyepiece asph 305543 9901 000 Assista...

Page 166: ...le and stand base NDS 24 HDTV monitor Base for 23 24 HDTV monitor HD SDI video cable 75 Ohm 2 x BNC pin 5 m 308203 2021 000 000000 0498 394 305989 8763 000 NDS 26 HDTV monitor with 5 m HD SDI video ca...

Page 167: ...nited States United Kingdom Switzerland Argentina China Brazil 000000 0149 592 397902 9058 000 309850 9003 000 000000 0228 202 000000 0434 527 000000 0475 506 000000 0526 671 Description Order number...

Page 168: ...d foot control panel new Wired foot control panel with 14 functions 3 m Foot control panel with 14 functions cable connected FCP 3 m cable for foot control panel with 14 functions FCP FCP WL 304970 90...

Page 169: ...640 000 302755 8641 000 Country specific power cables 1 each required for CALLISTO eye EDIS and HD video system Europe United States United Kingdom Switzerland Argentina China Brazil 000000 0301 997 0...

Page 170: ...th straight tube 6 caps per pack 305810 9006 000 Asepsis caps VISULUX rubber caps for VISULUX 2 caps per pack 305810 9009 000 Asepsis caps for handgrips resterilizable rubber caps for handgrips on the...

Page 171: ...ectrical devices systems It is labeled with The device complies with Directive 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Classific...

Page 172: ...r transport and storage Feature Admissible range Temperature 10 C 40 C Relative humidity 30 75 Air pressure 700 hPa 1060 hPa Feature Admissible range Temperature Without 1Chip HD camera With 1Chip HD...

Page 173: ...the orientation of the image by using the fundus imaging system or wide angle optics Depth of field Range of depth that appears sharply defined through the microscope Radiation intensity Emitted or ve...

Page 174: ...anagement systems EMC Electromagnetic compatibility defines non interference of electrical and electronic devices with their environment EN European Standard Europ ische Norm FCC Federal Communication...

Page 175: ...IOM 3 fundus viewing system 26 96 Bracket for foot control panel 46 Button assignment on foot control panel preconfigured 54 C Cable clip 46 Cable connections 75 Cable connections for the 1Chip HD cam...

Page 176: ...on arm 45 tubes 42 widefield eyepieces 43 D DeepView depth of field management system 38 Depth of field management system DeepView 38 Device overview 33 Diagnostic purposes 13 Diopters adjusting ring...

Page 177: ...adjusting distance 84 cup 43 F Failures halogen 130 main function 131 Filters KK 40 22 47 knob 47 retina protection filter 22 Foot control panel 34 button functions 54 components 53 configuring 110 co...

Page 178: ...limiting vertical movement 45 Locking tab 46 M Main microscope 36 Maintenance 137 Malfunctions error messages on the 5 7 control panel 135 foot control panel 135 system 132 Maneuvering handling for po...

Page 179: ...agnification 124 Performing black balance procedure 120 Positioning the device in the OR 81 Power switch 52 Preparation for use 59 Preparing for sterile use 86 Prior to the initial start up 91 Protect...

Page 180: ...l microscope adjusting 84 Suspension arm 44 Switch manual mode 24 52 power switch 52 sliding switch for rated voltage 48 Switching on off 91 Symbols and labels on the device 28 System overview 34 trou...

Page 181: ...a 112 3 CCD video camera 116 Video devices connecting 79 Video mode adjusting 1CCD 113 adjusting 3CCD 117 assigning 1CCD 112 assigning 3 CCD 116 Video objective lenses connecting 55 Video Output BNC 5...

Page 182: ...OPMI Lumera i Version 8 0 Page 182 G 30 1720 en...

Page 183: ...Version 8 0 G 30 1720 en Page 183 OPMI Lumera i Blank page for your notes...

Page 184: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Fax 49 0 7364 20 4823 E mail surgical meditec zeiss com Internet www meditec zeiss com...

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Zeiss OPMI Lumera i, Instructions For Use Manual

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