Zeiss VISUREF 150 User Manual Download Page 19

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Registro ANVISA n°:

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Summary of Contents for VISUREF 150

Page 1: ...ZEISS VISUREF 150 Autorefractor Keratometer Documentation set...

Page 2: ...ks Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability It does not however continuously check for any changes which could form the basis...

Page 3: ...000000 2227 967 Inhalt0 GB 281021 Contents User manual ZEISS VISUREF 150 Autorefractor Keratometer 000000 2227 967 GA GB 281021...

Page 4: ......

Page 5: ...ZEISS VISUREF 150 Autorefractor Keratometer User manual...

Page 6: ...000000 2227 967 GA GB 281021...

Page 7: ...duct 10 External labels 11 Performance specifications 14 Functional description 14 Service life 15 Description of the device 16 Installation 19 Notes on installation and use 19 Unpacking the device 19...

Page 8: ...1 Preparation of the device for measurement 51 Positioning the patient and explaining the procedure to the patient 57 Performing a measurement 58 Data display in the review screen 61 Measurement of pu...

Page 9: ...07 Care and cleaning 108 Cleaning and disinfection of painted surfaces 109 Safety inspections 110 Transport 111 Transport without packaging 111 Transport with packaging 111 Technical data 113 Electrom...

Page 10: ...ve for safe and effective functioning You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using the device for the first time The user manuals and...

Page 11: ...mation in this user manual and on device labels WARNING Indicates a hazardous situation which may result in death or serious bodily injury if the appropriate safety precautions are not heeded CAUTION...

Page 12: ...en delivered 4 Documentation set 5 Dust cover 6 2 fuses see Section Technical data page 113 7 Data carrier with source data of free software components optional 8 Network cable 9 USB storage device 10...

Page 13: ...ent prevention regulations Further notes on classification are to be found in Section Technical data page 113 and following Device group 1 in accordance with ISO 15004 2 max radiation intensity 117 1...

Page 14: ...ts who are unable to sit upright in front of the device Patients who have forehead or chin injuries that prevent the head from being supported on the forehead chin rest Patients whose eyes exhibit an...

Page 15: ...d maintained by persons who have been properly trained or who have the required knowledge and experience to do so Please also adhere to the national qualification guidelines applicable in your country...

Page 16: ...l of the product within the EU In accordance with applicable EU guidelines and national regulations at the time at which the product was brought onto the market the product specified on the consignmen...

Page 17: ...Country specific information and labels 000000 2227 967 GA GB 281021 11 External labels Fig 2 External labels 7 2 18 14 4 1 6 5 17 8 9 10 16 15 11 12 13 19 3 20 21...

Page 18: ...VISUREF 150 Catalogue number part number Serial number UDI Unique device identification code data matrix and plain text 3 Device identification code data matrix serial number and device name 4 Label...

Page 19: ...l with fuse specifications 13 Information label Disconnect device from the power supply before opening 14 Not applicable Not applicable 15 Applied part type B 16 Applied part type B 17 Not applicable...

Page 20: ...purpose of enhancing the visual inspection of the measured object and optimizing the measurement These include the intensity of the ambient light on the measured object reference illumination and ill...

Page 21: ...directory on a network folder and or USB drive Furthermore the measured data can be sent to a network printer for printing or to the ZEISS subjective refraction system comprising the VISUSCREEN 100 50...

Page 22: ...the device 1 Status LED illuminated device switched on flashing screen saver activated 2 LCD monitor 3 Printer cover 4 Stage locking lever 5 Buttons for chin rest height adjustment 6 Measuring button...

Page 23: ...000000 2227 967 GA GB 281021 17 1 Forehead rest 2 Measurement window 3 Dust cap 4 Chin rest 5 Fixing pins for chin rest paper 6 Canthus markers Reference mark for optimum eye level of patient Fig 4 Pa...

Page 24: ...00 2227 967 GA GB 281021 18 1 Clamping screw to lock the stage for transportation 2 Fuses 3 Power input socket 4 Monitor output 5 USB port with cover 6 Power switch 7 RS232 interface 8 Network connect...

Page 25: ...store alcohol and other flammable vapors and liquids in the vicinity of this equipment CAUTION DANGER FROM FALLING PARTS When selecting a suitable table ensure that the combination of table and devic...

Page 26: ...head or the patient We recommend the use of a height adjustable instrument table This facilitates the positioning of the patient in front of the device for achieving good measuring results Do not use...

Page 27: ...data on the type label WARNING RISK OF ELECTRIC SHOCK Be sure to turn off the power switch before connecting to or disconnecting the device from a power supply grid Connect the power supply cable int...

Page 28: ...g further equipment to medical device you are configuring a medical system and are thus responsible for ensuring compliance with the requirements for medical electrical systems Please observe that loc...

Page 29: ...ronment Measures for reducing leakage current include using a medically approved isolation transformer If a non medical grade LCD monitor or PC is to be used with the autorefractor keratometer system...

Page 30: ...If devices are used which do not comply with IEC 60601 1 an isolating transformer is required to power the device or connect the devices to additional protective grounding 3 2 1 5 4 6 1 Peripheral eq...

Page 31: ...logical or physical network configuration New integration or removal of other network participants or network accessories Updates or upgrades of network participants CAUTION PROPERTY DAMAGE When conn...

Page 32: ...ation The device does not require any special network settings for proper functioning If the network is incorrectly configured the basic functioning of the device will not be impaired although some of...

Page 33: ...device has been started booted the start up screen will be displayed Fig 8 Start up screen During initial start up of the device or after a reset to factory settings an input mask will be displayed f...

Page 34: ...alization Here you can set basic settings of your device These settings can be displayed and modified at any time using the Device settings symbol Select the desired language and tap on Next Fig 9 Dev...

Page 35: ...ectivity Using the serial interface Switch off both devices and plug the RS 232 cable into the corresponding connecting ports of the ZEISS VISUREF 150 7 Fig 5 and the receiving device e g your i Com s...

Page 36: ...ace enablement menu see Section Interface submenu page 95 Exit the device settings The SMB2 protocol is used for communication with the network server Direct data transmission via network Connect the...

Page 37: ...ORUM user manual and the corresponding instructions Switch to device settings Enable the interface in the Interface Interface enablement menu see Section Interface submenu page 95 Open the Interface L...

Page 38: ...Initial start up 000000 2227 967 GA GB 281021 32 Fig 11 Enter the peer address and select output format and protocol...

Page 39: ...bmenu page 95 Open VISUCONSULT 500 and note the IP address of your i Com server Open the Interface LAN Network socket menu see Interface submenu page 95 Enter the IP address of your i Com server into...

Page 40: ...n via web server is only possible if your EMR PMS system supports this data exchange service Connect the device to your network To do this plug the network cable 8 Fig 1 into the relevant socket 8 Fig...

Page 41: ...are missing or damage is visible the device should not be used and should be taken out of service WARNING RISK OF ELECTRIC SHOCK Please take care that the following operational requirements are met b...

Page 42: ...device if you do not know the user PIN Contact your device administrator Fig 13 Entering the user PIN Open the printer cover 3 Fig 3 and check that the printing paper is properly inserted and suffici...

Page 43: ...hand or fingers under the chin rest This could result in damage or injury CAUTION RISK OF FALSE DIAGNOSIS Direct and lateral light incidence to the front of the device or eye being examined should be...

Page 44: ...ng messages are displayed on the screen Fig 14 Error message example Operating concept Position the patient for measurement using the joystick 7 Fig 3 and buttons for chin rest height control 5 Fig 3...

Page 45: ...screen contains measurement and review screens The device settings can also be changed see Section Device settings page 87 The different setting menus can be opened by tapping the Settings icon 7 Fig...

Page 46: ...me 3 Refraction measurement mode Refraction 4 Pupil diameter measurement mode Pupil 5 Image capture mode Image 6 Contact lens measurement mode 7 Settings 8 Lock device 9 Upper navigation bar 10 Lower...

Page 47: ...n be shown grey letters 5 Settings 6 Upper navigation bar 7 Display field for left eye measurement results OS 8 Navigation arrow to results of single measurements optional 9 Lower navigation bar 10 Se...

Page 48: ...The Device settings window has up to three navigation levels consisting of an upper tab display 2 Fig 19 a lower tab display 4 Fig 19 and various detail pages 3 6 Fig 19 The selected upper and lower t...

Page 49: ...cond navigation level 5 Number of detail pages on third Navigation level current selection is highlighted in black 6 Direction arrows for navigating through the detail pages third navigation level Fig...

Page 50: ...s shown summarizing the information input field and input format 14 Fig 21 Capitals can be entered using the Cap button 12 Fig 21 or the Shift button 11 Fig 21 If these buttons are activated they appe...

Page 51: ...input field 4 Delete the character before the current cursor position 5 Enter button for line break 6 OK button Save and close 7 Buttons for positioning the cursor 8 Access to punctuation marks long...

Page 52: ...be identified by a device internal counter and not allocated to patient data The various options offered for linking measurement and patient data are explained in Section Patient selection page 47 Th...

Page 53: ...to display the patient list as a pull down menu The list is not updated in the overview screen To update the list go back to the measurement screen 13 Fig 17 The user has now several options Select a...

Page 54: ...ously selected from the patient list the device goes back to the unscheduled patient selection as the default setting Patients are displayed in the patient list in chronological order of assignment to...

Page 55: ...exception of the family name all elements of the pattern are optional The different elements can only partially describe the searched data record The abbreviations m male f female or d diverse can be...

Page 56: ...GB 281021 50 Fig 23 Text input field to define a patient search Select a patient from the displayed list Fig 24 Fig 24 Patient selection list In Russian Korean Japanese and Chinese languages the patie...

Page 57: ...atient default setting Select the Refraction menu in the upper navigation bar As soon as the word Refraction is displayed in blue the Refraction measurement mode is enabled 1 Fig 25 Select the mode fo...

Page 58: ...mode Checking the device settings Check the enabled device settings for refraction measurement Use the parameter control panel 4 Fig 25 on the measurement screen or the general access to device settin...

Page 59: ...e parameter control panel are not to be edited with a single click this function can be disabled To do this select the Direct control parameter in the Interface User User interaction tabs of the Devic...

Page 60: ...pathological finding the Standard mode illumination parameters can be retained Table 3 summarizes the illumination parameters of the device Illumination parameters Description Scale Reference Controls...

Page 61: ...case of a user defined change of illumination parameters the device cannot perform keratometry Keratometry values can only be measured in Standard and IOL illumination mode Illumination mode Applicat...

Page 62: ...u can also return to the pre set illumination modes by selecting Standard or IOL Table 4 If you use one of the pre set modes the illumination parameters are displayed in grey Fig 28 If you use the IOL...

Page 63: ...tons 5 Fig 3 adjust the motorized chin rest so that the patient s eyes are set to the height of the Canthus marks 6 Fig 4 Disinfect the chin rest after each patient CAUTION RISK OF PINCHING The motori...

Page 64: ...the pupil into the inner ring of the cross hairs move the joystick to the left or right For fine adjustment of the height rotate the joystick As soon as the eye is focused and centered the cross hair...

Page 65: ...f measurement results for a measurement sequence of OD measurement screen without display of pupil distance Patient eye identified laterality displayed cross hairs displayed in yellow as eye is not ce...

Page 66: ...results for a measurement sequence of OS measurement screen including display of pupil distance Now tap on Review to switch to the review screen in refraction mode and display the measurement results...

Page 67: ...is SE Spherical equivalent Keratometry R1 Corneal curvature radius for flat meridian K1 k value for flat meridian R2 Corneal curvature radius for steep meridian K2 k value for steep meridian A Axis of...

Page 68: ...es of each parameter and each measurement within this measurement sequence can be displayed The detailed display 7 Fig 33 can be opened by tapping on the desired measurement value in the corresponding...

Page 69: ...onvert them on the basis of the selected parameters Depending on the selection of the output unit of keratometry the user interface shows the R1 or R2 corneal curvature values in mm or the K1 or K2 va...

Page 70: ...nctions in Pupil mode Preparation of the device for measurement Selecting the measurement mode Select the desired patient from the patient list see Section Patient selection page 47 or start anonymize...

Page 71: ...Pupil measurement mode enabled 3 Laterality display 4 Live image of the eye moving 5 Open the review screen 6 Confirmation disabled 7 Zoom disabled 8 Illumination Fig 38 User interface in Pupil measur...

Page 72: ...e of the eye using the joystick Press the measuring button of the joystick 6 Fig 3 to capture an image As soon as the device has captured an image the moving live image 4 Fig 38 will be replaced by th...

Page 73: ...etermined from the distance of the two measurement lines will be displayed below the laterality display 1 Fig 39 This value changes with each movement of the measurement line In order to perform a mea...

Page 74: ...om function in Pupil mode Close the pop up window Zoom by tapping again on the Zoom button After closing the Zoom pop up window the selected magnifying factor is displayed beside the magnifying glass...

Page 75: ...eturns to the live image mode see also Fig 36 and Fig 38 Now you can measure the diameter again Fig 42 Confirm image discard When both measurement lines are correctly positioned confirm the measuremen...

Page 76: ...aragraph Data display in the review screen page 61 of Section Measurement of refraction and keratometry The image on which the measurement is based and the measurement lines are stored together with t...

Page 77: ...st see Section Patient selection page 47 or start anonymized measurement default setting Select the Image menu in the upper navigation bar As soon as the word Image is displayed in blue the Image meas...

Page 78: ...firmation 5 6 Fig 45 buttons are disabled 1 Image capture mode Image enabled 2 Laterality display 3 Live image of the eye moving 4 Open the review screen 5 Confirmation disabled 6 Zoom disabled 7 Sele...

Page 79: ...take an image of the eye Focus and center the displayed live image of the eye using the joystick Press the measuring button of the joystick 6 Fig 3 to capture an image As soon as the device has captu...

Page 80: ...measuring button on the joystick once 6 Fig 3 A query is displayed if you want to discard the image really This message can be suppressed by changing the device settings in the Interface User User in...

Page 81: ...right eye OD Fig 47 Image review screen with 4 images When tapping on the displayed preview images 1 and 7 Fig 47 a pop up window will open to display the selected image in full screen mode Fig 48 Th...

Page 82: ...ages in full screen mode Fig 48 Image capture in full screen mode Now finish the image capture by one of the following actions Save the images by tapping Finish Further notes on this are to be found i...

Page 83: ...of the test eye and insert the contact lens 2 Fig 1 and insert the contact lens so that its convex side points downwards to the test eye surface Fig 49 Fig 49 Attaching the contact lens to the rear o...

Page 84: ...to perform measurement Tap on the corresponding side of the two function button The activated measurement mode will be displayed in white on a blue background In Manual measurement mode measurement is...

Page 85: ...reen 6 Parameter control panel disabled 7 Select the illumination parameters disabled Fig 51 User interface in contact lens measurement mode Focus and center the measuring head as described in Section...

Page 86: ...esults in the measurement screen of contact lens mode To measure another contact lens release the test eye from the chin rest and carefully remove the contact lens Repeat the steps described in Sectio...

Page 87: ...ry subsection Data display in the review screen page 61 Fig 53 Contact lens review screen with detailed display of a single measurement value Finish the measurement by one of the following actions Sav...

Page 88: ...reselection of data to be deleted example for refraction keratometry data If you want to delete data of a certain single measurement and not all data of a selected type navigate to the display of the...

Page 89: ...ed during measurement of the pupil diameter the corresponding measurement value will also be deleted Delete a selected patient from the current patient list of the device or delete the complete list D...

Page 90: ...ough the various elements of the open measurement Output of measurement results Measurement results can be output using the Finish button This button has two functions On the left side the word Finish...

Page 91: ...sh button By tapping on the corresponding line you can perform one of the options in the Finish pop up window During measurement result output details on the individual steps are displayed on the scre...

Page 92: ...e device the next patient in the list will be selected Use the Patient ID context menu 1 Fig 22 to select another patient or anonymized measurement unscheduled patient option Configure the measurement...

Page 93: ...f the access to device settings is protected by a PIN code see page 34 you will be asked to enter the administrator PIN code Fig 59 After you have entered the PIN code correctly the Device settings wi...

Page 94: ...21 88 General submenu On the second navigation level in the General submenu you can find the Basic settings Administration and Service tabs Fig 60 Table 5 explains the user setting options in the Gene...

Page 95: ...eric code Administration PIN protection for administration and configuration of the device Enabled Disabled Administrator PIN Define a PIN for administration configuration of the device Numeric code S...

Page 96: ...e desired file can be selected Save log file Saves the log file of the device on a USB drive or network folder No selection possible Reset to factory settings Resets the device to factory settings All...

Page 97: ...device Last mode Refraction Pupil Image Contact lens Trigger mode Select manual or automatic measurement triggering On manual triggering the user must release measurement by pressing the measurement b...

Page 98: ...021 92 Output submenu On the second navigation level in the Output submenu you can find the Basic settings Format and Advanced settings tabs Fig 62 Table 7 explains the user setting options in the Out...

Page 99: ...op up menu is shortened by one line Back Local printer Local printer template Network printer Network printer template No option Menu option 1 Menu option 2 Menu option 3 Menu option 4 Format Page 1 2...

Page 100: ...ade in the recent past on neighboring devices only if web service is enabled see following parameters Consider allocations on neighboring devices Allows you to access the data of patients for whom mea...

Page 101: ...Interface submenu On the second navigation level in the Interface submenu you can find the Basic settings User Printer Serial USB and LAN tabs Fig 63 Table 8 explains the user setting options in Inte...

Page 102: ...etwork printer Enabled Disabled Folder Enabling data input output via network folder Enabled Disabled Socket Enabling direct data output on EMR PMS application within the network Enabled Disabled Web...

Page 103: ...the second eye the device automatically switches to the review screen Standard Simplified User Page 3 3 Sound playback Monitor Sound playback upon tapping the screen No beep Low beep Loud beep Joysti...

Page 104: ...rotocol of serial interface Blind transmission Other protocols depend on installation USB interface Output path 1 Definition of output path 1 for saving measurement data on a USB drive Text input of o...

Page 105: ...the IP address or the network name of the domain controller Text input Example guest1 domain server1 Password Input of a user name and the corresponding password to get access to the file server Input...

Page 106: ...User name Input of a user name and the corresponding password to access the EMR PMS application Text input Password Output format Selection of a communication protocol for data storage in the EMR PMS...

Page 107: ...e device this can be found in the device settings in the Interface LAN submenu in the address line of your browser Use the Navigator menu 3 Fig 64 to comfortably access the web server outputs of the o...

Page 108: ...tion of the device and its location In step 4 5 load a ppd file suitable for your printer and then tap Add printer In step 5 5 configure the added printer You can find ppd files for example at http ww...

Page 109: ...c shock Penetration of substances Smoke sparks or strange noises Faults that cannot be remedied based on the information provided in this user manual Label the device clearly as out of service and rep...

Page 110: ...note the information in section Replacing the printer paper roll page 107 and following The device displays the heading Error and the error message The operation failed due to an internal error Vario...

Page 111: ...s with information on the update process Wait until the process is completed and the window closes again After the successful update remove the USB drive from the USB port of the device If required di...

Page 112: ...e fuses disconnect the device from the power supply to prevent the risk of serious injury or death Replace the fuses in the power input module with fuses that conform with the specifications in Sectio...

Page 113: ...he body case Open the printer cover Install the paper roll so that the printable side of the paper smoother and shinier than the other side faces upwards when fed through to the printer assembly Feed...

Page 114: ...ol tested with isopropyl alcohol 60 For aldehyde tested with glutaraldehyde 2 For quaternary compounds tested with DDAC 0 2 CAUTION RISK OF FALSE DIAGNOSIS Use the supplied cover to protect the device...

Page 115: ...tions on the cleaning cloth packaging This will enable you to maintain the high image quality of your product Cleaning and disinfection of painted surfaces All painted surfaces may be cleaned with a d...

Page 116: ...ing device using the power cable To perform the measurement press the measuring tip against the metallic holding plate Fig 67 of the plugs on the bottom of the device The measured value may not exceed...

Page 117: ...ith packaging Switch off the device at the power switch and disconnect the power cable from the device Lock the stage using the clamping screw 1 Fig 5 and lever 4 Fig 3 Use the supplied plastic bags a...

Page 118: ...injure you Hold the ribbon on both sides of the cut Wear protective gloves when unpacking the device Unpack the device on a level surface to prevent slipping CAUTION PROPERTY DAMAGE Do not place heavy...

Page 119: ...ustment max 65 mm Internal printer Type Thermal printer Printing paper Thermal paper width 57 mm external diameter of roll 50 mm surface weight 60 g m thickness 59 m Refractometry Corneal vertex dista...

Page 120: ...3 mm 0 05 mm 4 2 Ambient conditions for intended use Temperature Relative humidity Atmospheric pressure Shock without packaging 10 C to 40 C 30 to 90 70 kPa to 106 kPa 10 g 6 ms Ambient conditions for...

Page 121: ...EC 60601 1 Therefore no limitations on essential performance of ZEISS VISUREF 150 are to be expected due to electromagnetic interference CAUTION GENERAL HAZARDS If operation is required in the domesti...

Page 122: ...uthorized by Carl Zeiss Meditec The use of accessories all types of transducers and cables not specified in this user manual or not sold by Carl Zeiss Meditec as replacement parts may result in higher...

Page 123: ...at 1 kHz Electrical fast transient burst IEC 61000 4 4 2 kV 100 kHz repetition rate power cable 1 kV 100 kHz repetition rate data cable Surge voltage surges line to line IEC 61000 4 5 0 5 kV 1 kV pow...

Page 124: ...y wireless communications equipment in accordance with IEC 60601 1 2 IEC 61000 4 3 385 TETRA 400 27 450 GMRS 460 FRS 460 28 710 LTE Band 13 17 9 745 780 810 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE...

Page 125: ...trademarks of Apple Inc CUPS is protected by copyright 2007 2014 by Apple Inc all rights reserved D Diopter DDAC Quaternary ammonium compound for disinfection and cleaning EMR Electronic medical reco...

Page 126: ...45 Fig 22 Unfolded patient list 48 Fig 23 Text input field to define a patient search 50 Fig 24 Patient selection list 50 Fig 25 User interface in Refraction measurement screen automatic measurement...

Page 127: ...ed contact lens in front of the measuring head 78 Fig 51 User interface in contact lens measurement mode 79 Fig 52 View of measurement results in the measurement screen of contact lens mode 80 Fig 53...

Page 128: ...s via long touch 44 Table 3 Description of illumination parameters 54 Table 4 Overview of illumination parameters in different illumination modes 55 Table 5 Parameters in the General submenu 90 Table...

Page 129: ...ly startup 35 Description of the device 16 Device software 105 Disposal 10 E Electromagnetic compatibility 115 External labels 11 F Figures 120 Functional description 14 G Glossary 119 I Installation...

Page 130: ...281021 124 P Package check list 6 Performance specifications 14 R Replacing the fuses 106 S Safety inspections 110 Service life 15 Shutting down 103 Switching off 103 Switching on 36 Symbols 5 T Techn...

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Page 132: ...c AG G schwitzer Strasse 51 52 07745 Jena Germany Telephone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med 000000 2227 967 GA GB 281021 ZEISS VISUREF 150 S...

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Page 134: ...rl Zeiss Meditec AG G schwitzer Strasse 51 52 07745 Jena Germany Telephone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med ZEISS VISUREF 150 Subject to chan...

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