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OCULUS Vissard 3D Instruction Manual

Vision testing device

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OCULUS
Vissard
INSTRUCTION MANUAL
Vision Testing Device

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Summary of Contents for OCULUS Vissard 3D

  • Page 1 OCULUS Vissard INSTRUCTION MANUAL Vision Testing Device...
  • Page 2 2 / 2 (G/16040/EN - Rev02) Instruction Manual Vissard...
  • Page 3 Preface The OCULUS Vissard has been manufactured and tested according to strict quality criteria. To ensure safe operation, it is essential that you use the device correctly. For this reason, you should thoroughly familiarize yourself with the contents of this instruction manual before operating the device. In particular, pay attention to the safety instructions.
  • Page 4: Table Of Contents

    Electrical Connection..................22 Turning On and Turning Off................. 24 7.3.1 Switching the Control Unit On and Off ........24 7.3.2 Turning On and Turning Off the Vissard 3D/Vissard RG.. 24 Install the Vissard App..................24 7.4.1 On the iPad..................24 7.4.2 Connect to Wi-Fi ................
  • Page 5 10.2.2 Maintenance Mobile Components: Charge Rechargeable Battery49 11 Troubleshooting ......................52 11.1 Installation of the Vissard Software Update on the Vissard 3D/ Vissard RG53 11.2 Perform Pairing ....................56 12 Transport and Storage ....................60 12.1 Transport and Storage Conditions .............60 12.2 Disassembly......................61 12.3 Transport and Storage ..................61...
  • Page 6 6 / 74 Vissarde (G/16040/EN - Rev02) Software Installation...
  • Page 7: Scope Of Delivery

    Vissard 3D, linear polarisation 16030  Vissard 3D, circular polarisation 16031  Vissard RG 16050  G/16040/XXXX/EN Instruction Manual Vissard 3D/Vissard RG: Fuse 1.25 A time-lag 05100170 Optional Vissard PHI 16090  Holder for receiver  016595001043 Data cable for phoropter ...
  • Page 8: Graphic Symbols

    2 Graphic Symbols Graphic Symbols On the Equipment / Type Plate Fig. 2-1: Type Plate (example) 1 Manufacturer’s logo Disposal in household trash is prohibited 2 Manufacturer’s address Medical Device 3 CE European Conformity Power supply unit 4 Heed Instruction Manual Fuses 5 UDI number Serial number of the device...
  • Page 9: On The Packaging

    2 Graphic Symbols On the packaging Pictogram Description Pictogram Description Permitted temperature range for Permitted temperature range for Transport Storage transport storage Keep dry Humidity Transport upright Air pressure Fragile Instruction Manual Vissard (G/16040/EN - Rev02) 9 / 74...
  • Page 10: Layout Of The Documentation

    3 Layout of the Documentation Layout of the Documentation Instruction Manual: The design of the unit is described in detail in  this document. The Instruction Manual also includes basic instructions and all safety-related instructions for the use of the Vissard.
  • Page 11: Safety Instructions

    4 Safety Instructions Safety Instructions Carefully read through the Instruction Manual.  Keep the documentation in a safe place in the vicinity of the unit.  Observe the legal regulations with regard to accident prevention.  Pictograms in this manual Warning Indicates a potentially hazardous situation that can lead to irreversible bodily injury.
  • Page 12: Safety Instructions For Use

    Transport and storage instructions Refer to the notes in sect. 12, page Put the Vissard 3D/Vissard RG down so that it cannot fall over.  Instructions for setup and connection The Vissard may only be installed and connected by OCULUS or its ...
  • Page 13: Information About The Patient Environment

    4 Safety Instructions Patient display, distance: Protect the unit against dust. There is a  risk of fire. Use only a mains cable that meets the requirements of IEC 60227-  1, Type 53, min. 0.75 m² and of IEC 60320-1. Position the Vissard so that the mains plug is readily accessible.
  • Page 14: Instructions For Operation

    Always maintain a minimum distance of 15 cm between your  medical device and the control unit. Instructions for operation Before initial operation: Let OCULUS or an authorized dealer train  you in the operation of the Vissard. Never operate damaged Vissard components.
  • Page 15: Instructions For Maintenance

    Take hold of the plug, do not pull on the cable. Vissard 3D/Vissard RG: The device may only be disassembled and  reassembled by OCULUS service person or an authorized dealer.
  • Page 16  scope of delivery. If you use a new control unit for the Vissard that is not supplied by OCULUS, you must have it checked for electrical safety. Call OCULUS Service for this purpose. Attention Risk of personal injury or material damage caused by multiple socket extension cord Do not use a multiple socket extension cord.
  • Page 17: Intended Use

    Images and a fixation video (Vissard 3D and Vissard RG only)  Contrast sensitivity testing under photopic conditions  Light and dark refraction (Vissard 3D and Vissard RG only), with and  without glare The Vissard must only be used for the purpose specified in this Instruction Manual.
  • Page 18: Device Description

    6 Device Description Device Description Overview of Device Components Fig. 6-1: Overview Vissard 3D/Vissard RG 1 Monitor Service buttons Brightness sensor RS232 port for phoropter 3 Mains connection Network port 4 Fuses 2 x USB port 5 On/off switch LED for glare...
  • Page 19 6 Device Description Fig. 6-2: Overview: Control unit 1 Standby button Connection jack, e.g. for charger cable 2 Touchscreen Home button Instruction Manual Vissard (G/16040/EN - Rev02) 19 / 74...
  • Page 20: How The Vissard Vision Screening Unit Works

    Vissard RG: Use of the anaglyph method (red-green separation)  Attention The company OCULUS Optikgeräte GmbH cannot be held responsible for the further use of the data acquired with and the evaluations calculated with the Vissard in any form whatsoever.
  • Page 21: Installation And Connection

    Make sure that the unit is properly secured to the wall. Incorrect examination results due to incorrect settings If you temporarily dismount the Vissard 3D/Vissard RG and want to remount it, the correct settings could change. After dismounting the unit, have it remounted by OCULUS Service ...
  • Page 22: Electrical Connection

    210 — 220 cm approx. 130 — 135 cm approx. 135 — 140 cm Patient position: Straight, looking toward the centre with Patient position: Vissard 3D/Vissard RG with deflection the Vissard 3D/Vissard RG mirror Fig. 7-1: Patient positions Electrical Connection...
  • Page 23 Please pay attention to the specifications on the nameplate.  If the plug is faulty, contact OCULUS Service or an authorized dealer to repair the damage. Plug in the power plug. When doing so, hold of the plug and not ...
  • Page 24: Turning On And Turning Off

    Minimum requirement for the installation: iPad with current iOS version  Note OCULUS cannot be held liable for damage incurred as a result of incorrect installation. Follow these instructions when performing an installation.  24 / 74 Instruction Manual Vissard (G/16040/EN)
  • Page 25: Connect To Wi-Fi

    7 Installation and Connection 7.4.2 Connect to Wi-Fi To be able to update apps or download new apps, the iPad must be connected to the Internet. You’ll therefore need to connect your iPad to the Wi-Fi. (Alternatively, you can use a data cable to connect it to a PC with an Internet connection - not described in these instructions.
  • Page 26: Using The Vissard App With Your Own Apple Id

    7 Installation and Connection Enter the password (or login data) for the Wi-Fi.  Fig. 7-4: Enter Wi-Fi password Click on [Join].  7.4.3 Using the Vissard app with your own Apple ID Requirements: Your iPad must be registered on an active Wi-Fi, see also fig.
  • Page 27 7 Installation and Connection Downloading the Vissard app Log on with your own Apple ID.  Open the App Store.  In the search field, type in (for example): Vissard.  Fig. 7-5: Finding the Vissard app Instruction Manual Vissard (G/16040/EN - Rev02) 27 / 74...
  • Page 28 7 Installation and Connection Click on [Search].  The following dialogue appears: Fig. 7-6: Downloading the Vissard app To download the Vissard app, go to [Get] > [Install]. You may need  to enter your (Apple account) password. If the following icon appears, the Vissard app is being downloaded. Fig.
  • Page 29: Operating The Vissard Program

    8 Operating the Vissard Program Operating the Vissard Program This section describes how to start the Vissard program, sect. 8.2, page 29  operate the multi-touch display of the control unit, sect. 8.2,  page 29 operate the elements of the Vissard program in general, sect.
  • Page 30: Using The Elements Of The Vissard Program

    8 Operating the Vissard Program Using the Elements of the Vissard Program Test selection presets [Up] and [Down] buttons [Settings] button Setting options for the presently activated test; here: visual acuity Test image shown to the patient Test selection Supplementary setting options for a test Selection of the test group Fig.
  • Page 31: Test Selection Presets

    8 Operating the Vissard Program Test selection presets (1) You can preset the display of the test groups and tests with these buttons. The appropriate tests are presented. You can also activate camera mode. Column button Description name Distance vision tests NEAR Near vision tests, 30 –...
  • Page 32: Supplementary Setting Options For A Test

    8 Operating the Vissard Program Supplementary information or setting options for a test (4) Buttons, with which you can modify the presently active test, are displayed here. The buttons are automatically adapted to the previously selected test. Depending on the test, supplementary buttons may not be displayed here.
  • Page 33: [Up] And [Down] Buttons

    8 Operating the Vissard Program Button Function Show the display inversely. Switch the 3D mode from polarisation mode to red-green mode. Change present test setting (6) Control elements, with which you can modify the present test, e.g. change the visual acuity levels for a visual acuity test, are displayed here. Button with visual acuity levels: Tap multiple times on a button.
  • Page 34: Change Settings

    8 Operating the Vissard Program Change Settings Depending on the constellation in which you use your Vissard components, you can change the various settings. Tap on the [Settings] button, fig. 8-2, page 30, item 2.  The following display appears. 1 [Done] button Mobile display settings 2 Software version...
  • Page 35: Change Settings For The Long-Distance Display

    8 Operating the Vissard Program 8.4.2 Change Settings for the long-distance Display Tap on "Long-distance display" [>] (fig. 8-3, page 34, item  The following display appears. 1 (Settings] button Wi-Fi settings 2 Device name field "Brightness display" settings 3 Option "Screensaver settings" "Brightness ambient"...
  • Page 36 Bluetooth may take several minutes. Option "Wallpaper" (4) Here you can select which wallpaper appears on the screen of the Vissard 3D and Vissard RG. You can select either a default wallpaper or your own wallpaper. Tap on "Detail" [>].
  • Page 37 8 Operating the Vissard Program Settings for the Homematic function (7) You can enter the following Homematic settings. Please contact OCULUS Service if you have any questions. IP Homematic Zentrale: Network address  Port: The port is generally already automatically entered ...
  • Page 38 8 Operating the Vissard Program Expert settings (13) You can change the following settings in the expert settings: Distance  Polarisation (Vissard 3D only)  Mirror display horizontal  To change the long-distance display and the mobile display settings, the respective display must be connected with the iPad.
  • Page 39 Set the test distance (1) The distance from the patient to the patient display can be set to suit the room with the Vissard software. Adjustment range Vissard 3D/Vissard RG 300 to 800 cm Tap on "Distance" [>].  Select the desired distance. The distance is specified in 10 cm ...
  • Page 40 8 Operating the Vissard Program Change polarisation direction (3) You can change the initial polarisation assignment for the right and the left eye here. Tap on "Polarisation" [>]  Select the desired polarisation direction.  Mirror display horizontal (4) If you are working with a deflection mirror, you can mirror the presentations here.
  • Page 41: Test Group Overview

    8 Operating the Vissard Program Test Group Overview The Vissard program offers a number of test groups that are made up of different tests. You can select the desired test group in the field for selection of the test group (fig.
  • Page 42 8 Operating the Vissard Program Test group Brief Description The stereo tests are used to test stereoscopic vision. The dominance test is used to determine which eye is dominant. You can activate a colour vision test with Ishihara colour charts. This function is not available for the Vissard MOBIL/Vissard LECTUS.
  • Page 43: Examination Procedure

    Examination Procedure Caution Risk of injury if the unit is not correctly mounted and secured. Vissard 3D/Vissard RG: Before use, check that the patient display  has been correctly mounted and secured. Never put an incorrectly mounted and secured patient display into operation. Call OCULUS Service, if necessary.
  • Page 44: Prepare The Patient

    9 Examination Procedure Prepare the Patient Check to be sure that any adaptation disorder has been resolved.  Check the patient’s glasses for damage or dirt.  Explain the procedure and the optotypes to the patient. You can  show the patient the following picture A ring with a gap in it is used as the test symbol (optotype).
  • Page 45: Mark The Optotype

    9 Examination Procedure Mark the Optotype You can mark the optotype that you want the patient to look at. A red square appears around the optotype in question. Lightly tap the selected optotype on the control unit.  Marked optotype Fig.
  • Page 46: Cleaning, Disinfection And Maintenance

    10 Cleaning, Disinfection and Maintenance Cleaning, Disinfection and Maintenance This chapter explains how to clean and maintain the Vissard components. Disinfection and sterilisation are not necessary. 10.1 Cleaning Attention Risk of electric shock if the components of the Vissard are not completely disconnected from the mains for these jobs.
  • Page 47: Care And Maintenance

     Risk of fire if the wrong fuse is used Use only the following fuse:  Vissard 3D/Vissard RG 1.25 A time-lag, Order number 05100170. Turn off the Vissard, sect. 7.3, page  Unplug the power cord.
  • Page 48 10 Cleaning, Disinfection and Maintenance Replace the blown fuse.  A blown fuse is indicated by burnt-out filaments (4). Insert the fuse holder (3). Make sure it fits properly. The pin (2) must  fit in the recess. Connect the Vissard to the mains. ...
  • Page 49: Maintenance Of The Mobile Components: Charge Rechargeable Battery49

    10 Cleaning, Disinfection and Maintenance 10.2.2 Maintenance of the Mobile Components: Charge Rechargeable Battery Display the charge status You can display the charge status of the rechargeable battery on the iPad. Abb. 10-4: Display of the charge status Charge the rechargeable battery Attention Risk of electric shock The use of damaged batteries, cables or chargers, or charging the...
  • Page 50 Disassembly of the mobile components can lead to injury and to permanent damage to the unit. Contact OCULUS or an authorized dealer if your mobile  components are damaged, are not working properly, or have come into contact with any liquids.
  • Page 51 Do not use excessive force when connecting the electrical plug.  Please pay attention to the specifications on the nameplate.  If the plug is faulty, contact OCULUS Service or an authorized dealer to repair the damage. Instruction Manual Vissard (G/16040/EN - Rev02) 51 / 74...
  • Page 52: Troubleshooting

    "out-of-order” and contact our service department or an authorized dealer. Fault Possible cause Remedy Vissard 3D/Vissard RG Image is not displayed Unit is switched off, Switch on the unit  Standby is switched on...
  • Page 53: Installation Of The Vissard Software Update On The Vissard 3D

    Installation of the Vissard Software Update on the Vissard 3D/ Vissard RG You have received the latest update of the Vissard software from OCULUS on an USB stick. You must install this software update in the Vissard 3D/Vissard RG (Vissard for short). Proceed as follows: Switch off the Vissard.
  • Page 54 11 Troubleshooting Wait: The software update will be installed automatically.  During the installation, the following screens appear: Display after successful installation Fig. 11-3: Successful installation When the message "Vissard Firmware has been successfully  installed" appears on the display, switch off the Vissard. Wait for at least four seconds and remove the USB stick, fig.
  • Page 55 11 Troubleshooting Switch on the Vissard. The software is updated.  Fig. 11-4: Vissard 3D display You can now establish a paired Bluetooth connection (pairing), sect. 11.2, page Instruction Manual Vissard (G/16040/EN - Rev02) 55 / 74...
  • Page 56: Perform Pairing

    Fig. 11-5: Service buttons at the underside of the Vissard 3D/Vissard RG The service buttons are also displayed on the screen. Service button "Confirm" Service button "Down" Service button "Up" Fig. 11-6: Display of the service buttons on the screen of Vissard 3D/Vissard RG 56 / 74 Instruction Manual Vissard (G/16040/EN)
  • Page 57 11 Troubleshooting Open the Vissard app on the iPad.  Fig. 11-7: Open the Vissard app on the iPad Go to “Settings”, and select option “Select long-distance display”  (sect. 8.4, page 34). A list of devices within the range for a Bluetooth connection is displayed.
  • Page 58 11 Troubleshooting Devices checked with a green tick already have a Bluetooth connection established. Re-pairing is not required. For unchecked devices, a Bluetooth connection must first be established before these devices can be used. Proceed the pairing as follows: Select the device to establish a Bluetooth connection with. ...
  • Page 59 11 Troubleshooting When pairing has been completed, the following message appears at the Vissard: Fig. 11-11: Bluetooth: Connected The connected device is displayed in the Vissard software at the iPad. Fig. 11-12: Display of the connected device Instruction Manual Vissard (G/16040/EN - Rev02) 59 / 74...
  • Page 60: Transport And Storage

    Avoid proximity to devices that can produce heat, e.g. heaters/  radiators. Avoid moisture.  Vissard 3D/Vissard RG: Do not touch the surface of the screen, if  possible, as this could damage it. Do not expose the mobile components to direct sunlight for any ...
  • Page 61: Disassembly

    Attention Incorrect examination results caused by improper dismounting and remounting If you temporarily dismount the Vissard 3D/Vissard RG and want to remount it, the correct settings could change. Let only OCULUS Service or an authorized dealer dismount and, if ...
  • Page 62: Disposal

    14.2 Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety, reliability and serviceability of the Vissard if the unit is used in compliance with the following terms: Only use the equipment in conformance with this Instruction ...
  • Page 63 14 Terms of Warranty and Service performance and statement of the performing company, with signature. If requested, OCULUS will provide to the service technician a list of  spare parts and additional descriptive material for this purpose. Make certain that only original OCULUS parts are used.
  • Page 64: Technical Data

    15 Technical Data Technical Data Vissard 3D/Vissard RG 24" LCD monitor (patient) Resolution 1920 x 1080 pixels (FHD) 2 – 320 cd/m² Brightness Test distance 3.0 – 8.0 m (in 0.1 m stages) iPad, Control phoropter (NIDEK RT-5100/RT-3100 and RT-6100) 680 x 54 x 448 mm (26.8 x 2.1 x 17.6...
  • Page 65 IEC 60320-1 Classification according to IEC 60601 - 1 Type of protection against electric shock Vissard 3D/Vissard RG  Control Unit  Level of protection against harmful penetration of IP 20 water...
  • Page 66: Appendices

    30 cm between the portable and mobile HF telecommunication devices (transmitters) and the device. Attention The use of accessories, converters, and cables that do not meet OCULUS specifications can result in increased emissions or a reduced interference immunity of the Vissard’s components.
  • Page 67 To ensure compliance with the requirements of IEC 60601-1-2 6.1 and 6.2, the following devices, accessories, converters and cables must be used: Order Number Description 16030 Vissard 3D, linear polarisation 16031 Vissard 3D, circular polarisation 16050 Vissard RG 10012081 Control unit (iPad)
  • Page 68: Guidelines And Manufacturer's Declaration Electromagnetic Interference Emission And Interference Immunity

    Electromagnetic Interference Emission and Interference Immunity Electromagnetic radiation The Vissard from the company OCULUS is approved for operation in the electromagnetic environment specified below. The user of the Vissard should ensure that it is used only in such an environment.
  • Page 69 16 Appendices Electromagnetic immunity Immunity tests DIN EN 60601- Compliance Electromagnetic environment Test level level - Guidelines Electrostatic discharge ± 8 kV contact Floor should be of wood or (ESD) in acc. with IEC 61000-4-2 discharge concrete or be covered with ±...
  • Page 70 16 Appendices Electromagnetic immunity Interference DIN EN ISO Compliance Electromagnetic environment - Guidelines immunity tests 60601 test level level Portable and mobile radio equipment, including the cables, should not be used any closer to the Vissard than the recommended 3 Veff separation distance calculated according to the 150kHz to 80MHz applicable equation for the transmission...
  • Page 71 16 Appendices Recommended separation distances between portable and mobile HF telecommunications devices and the Vissard The Vissard is intended for operation in an electromagnetic environment in which the HF interference parameters are controlled. The user of the Vissard can help to avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF-telecommunications equipment (transmitters) and the device - depending on the output power of the communications equipment, as specified below.
  • Page 72: Connection Diagram

    16 Appendices 16.3 Connection Diagram Mains connection Vissard control unit Patient display, distance Mains connection for rechargeable battery 72 / 74 Instruction Manual Vissard (G/16040/EN)
  • Page 73 16 Appendices Instruction Manual Vissard (G/16040/EN - Rev02) 73 / 74...
  • Page 74 WWW.OCULUS.DE OCULUS Optikgeräte GmbH PO box • 35549 Wetzlar • GERMANY Phone +49 641 2005-0 • Fax +49 641 2005-255 E-mail: sales@oculus.de • www.oculus.de...

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