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Summary of Contents for OCULUS Binoptometer 4P
- Page 1 ® OCULUS OCULUS Binoptometer Binoptomete INSTRUCTION MANUAL Vision Test Device...
- Page 2 In particular, pay attention to the safety instructions. Also read the User Guide Binoptometer 4P. There you will find all information about the screening programs and testing.
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Page 3: Table Of Contents
Table of Contents Table of Contents Delivery and Packing List ......................1 Symbols on the Equipment ......................2 About this Manual........................3 Structure of the Documentation................3 Software Version ......................3 Safety Instructions........................4 About this Manual ......................4 4.1.1 Used Graphic Symbols.................4 Safety Instructions for Use of the Binoptometer® 4P .........5 Intended Use..........................9 Device Description ........................ - Page 4 Table of Contents 11 Cleaning, Disinfection and Maintenance ................38 11.1 Cleaning ......................... 38 11.2 Disinfection ........................39 11.3 Care and Maintenance....................40 11.3.1 Forehead Rest Replacement ..............40 11.3.2 Replacing the Fuse ..................41 12 Transport and Storage ......................42 12.1 Disassembly and Packing ..................
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Page 5: Delivery And Packing List
1 Delivery and Packing List Delivery and Packing List Component Order number Binoptometer® 4P with height adjustment 59860 Alternative: Binoptometer® 4P without height adjustment 59862 Accessory kit, consisting of: 59871 Dust protection cover 02 59860 00 003 Instruction Manual G/59860/.../en User Guide BH/59860/../en Software Installation... -
Page 6: Symbols On The Equipment
2 Symbols on the Equipment Have the damage confirmed on the bill of lading so that an orderly handling of the complaint for damages is possible. Note: We reserve the right to change the scope of delivery in line with ongoing technical development. -
Page 7: About This Manual
3 About this Manual About this Manual Structure of the Documentation A folder containing a set of documentation is supplied with your Binoptometer® 4P: Instruction Manual: The design of the unit is described in detail in this document. In the Instruction Manual, you will also find all safety-related instructions for use of the Binoptometer®... -
Page 8: Safety Instructions
4 Safety Instructions Safety Instructions This chapter contains a summary of the most important safety-related information. About this Manual Read the User Instructions and the User Manual carefully. Keep the User Instructions handy and in the immediate vicinity of the equipment. -
Page 9: Safety Instructions For Use Of The Binoptometer® 4P
Personal injury or property damage due to equipment modifications which impair safety No modifications may be made to this device without the permission of the manufacturer. Only the OCULUS service and authorized dealers are allowed to modify the device Instructions for Operating Personnel ... - Page 10 4 Safety Instructions Patient environment information Patient environment is the area where patients can come into contact with any part of a medical electrical equipment (ME equipment) or with another person being in contact with the ME equipment. In the patient environment, use devices that conform to IEC 60601-1. If a multiple power socket is to be used, or if a device is to be used that does not meet the IEC 60601-1 standard, use an isolating transformer.
- Page 11 Before initial operation: Let OCULUS or an authorized dealer train you in the operation of the Binoptometer® 4P. Only operate the equipment after your have read and understood the User Instructions.
- Page 12 If you are using a new computer for the Binoptometer® 4P, you must have the electrical safety checked. Call OCULUS Service for this purpose. Electromagnetic Compatibility (EMC) / Cables Risk of personal injury or damage to property due to electromagnetic...
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Page 13: Intended Use
5 Intended Use Intended Use The Binoptometer® 4P is intended for the use described in this operating manual. The Binoptometer® 4P has the following testing options: Visual acuity test with Landolt rings, numbers, letters, and similar Binocular tests (phoria and stereo vision tests) ... -
Page 14: Device Description
6 Device Description Device Description Front View 1) Holder for external light shield 2) Forehead rest 3) Viewing window 4) Knob to adjust the viewing angle 5) Indicator light 6) Netbook/laptop/PC connection 7) Rocker switch for height adjustment (optional) Fig. 6-1: Front View Rear View 8) Handhold 9) Opening for service buttons... -
Page 15: Mode Of Operation Of The Binoptometer® 4P
Caution Risk of incorrect measurements/equipment damage due to improper setup Before using the Binoptometer® 4P for the first time, have our service department or an OCULUS-authorized specialist give you training. Instruction Manual Binoptometer® 4P (G/59860/1016/en) 11 / 55... -
Page 16: Set Up For Initial Use
7 First-time Operation Set Up for Initial Use The ambient conditions for operation are given in “Ambient Conditions” page Remove the Binoptometer® 4P from the packaging. Lift it with the handhold (fig. 6-2, page 10, item Place the Binoptometer® 4P on a level surface. ... -
Page 17: Connecting
7 First-time Operation Connecting You must connect the Binoptometer® 4P to the mains and, depending on the version, to the netbook, control unit or laptop / PC. Caution Electrical safety hazard Do not use the Binoptometer® 4P adjacent to or stacked with other equipment. -
Page 18: Software Installation
7 First-time Operation Netbook/ Laptop / PC Connection Connect the Binoptometer® 4P and netbook / laptop / PC with the appropriate cable. Fig. 7-1: Example: Connect to a netbook Make sure that the plug is inserted in the correct position. ... -
Page 19: Daily Startup
8 Daily Startup Daily Startup To start the Binoptometer® 4P for daily operation, you must: Install and connect the device Check the device viewer Turn on the device Note: Risk of equipment damage due to incorrect transport ... -
Page 20: Clean The Device Viewer
8 Daily Startup Clean the Device Viewer Check the device viewer for impurities. If impurities are found: Clean the viewer glass (1), also see sec. 11.1, page Fig. 8-2: Check the device viewer Use of the External Light Shield You can then still conduct the mesopic (twilight) vision test and glare sensitivity test, even if you cannot darken the room. -
Page 21: Conducting An Examination
9 Conducting an Examination Conducting an Examination How to proceed with an examination is shown here with an example using a netbook. If you do not want to document the test results with the software, you can record them in a test block. ... -
Page 22: Starting The Patient Data Management
9 Conducting an Examination 9.1.1 Starting the Patient Data Management After turning it on, the operating system boots up. Click on the Binoptometer® 4P icon: It then displays the user interface for "patient data management”. 1 "Functions” box 5 [Export] button 2 Previous examinations 6 [Import] button 3 [Delete exam] button... -
Page 23: Entering A New Patient
9 Conducting an Examination 9.1.2 Entering a New Patient Press the [New] button to enter a new patient into the patient data management system. Enter the patient’s complete last name, first name and date of birth in the patient window (8). Fig. -
Page 24: Change Settings
Enable the option to allow the patient’s gender to be entered in the patient data management, page 23 Enable to load an existing examination without using the OCULUS patient data management, page 23 Enable full screen mode when the program is started, page 23 ... -
Page 25: Select Language And Change Units Of Measure
9 Conducting an Examination Proceed as follows: Press the button [Settings]. The following dialog is displayed: "Language” box Button [System] "Date / Time” box Button [Print settings] "Font” box Box "Visual acuity data" [Options] button [Back] button Button [Edit programs] "Miscellaneous”... -
Page 26: Change Font Size Of Examination Display
9 Conducting an Examination Change font size of examination display "Font” box (fig. 9-5, page 21, item Enter the font size for the examination display. Enable the [Reset] tab to use the default font size. Change Visual Acuity Data "Visual acuity data"... -
Page 27: Enable Full Screen Mode When The Program Is Started
9 Conducting an Examination Show "Load examination" If you do not work with the OCULUS patient data management, you can use this function to load an existing examination. "Miscellaneous” box (fig. 9-5, page 21, item Enable the [Show "Load examination"] checkbox. -
Page 28: Release Optional Software Modules
9 Conducting an Examination Release Optional Software Modules Screen options: Device information Status of the software modules Tabs Fig. 9-8: "Options” screen You need this screen if you want to order optional software modules, see User Guide. Press the [Options] button (fig. -
Page 29: Edit Examination Program
Have the Device ID of the desired option available, e.g. the Device ID "Colorvision Symbols” (1). Call OCULUS service and ask them for your release code, sec. 15.3, page Enter the received release code in the line "Colorvision Symbols” in the "ReleaseID”... -
Page 30: Export To External Patient Data Management
9 Conducting an Examination Export to external patient data management You can export the patient data with this function. Press the button [System] (fig. 9-5, page 21, Pos. Fig. 9-11: GDT- und CSV-Export Activate either the checkbox [GDT] or [CSV]. ... -
Page 31: Change The Colour Test Presentation Times
9 Conducting an Examination Generate Detailed Printouts With this screen function, you can choose to output detailed results of the visual acuity and color sensitivity tests, or of the Amsler test. You can also enter additional information here, such as e.g. your office address and your logo, which will then subsequently appear on the results printout. -
Page 32: Prepare Patient For The Examination
9 Conducting an Examination Prepare Patient for the Examination After you have entered the patients in the patient list and possibly changed the settings, you must now prepare the patients for the examination. Check to be sure that any adaptation disorder has been resolved. ... - Page 33 9 Conducting an Examination If you have a Binoptometer® 4P with height adjustment feature, you can adjust the height either with the rocker switch, or via the Binoptometer® 4P program. With the rocker switch (1): Adjust the height of the device with the rocker switch (1).
- Page 34 9 Conducting an Examination Adjust the viewing angle to 0 degrees to complete a distance test. Patients with multi-focal or progressive lenses: Change the viewing angle if the test distance is shortened. The selected viewing angle is displayed in the test menu, see fig.
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Page 35: Select And Start Exam
9 Conducting an Examination Select and Start Exam If you’re using a netbook, laptop or PC: If necessary, press the [Binoptometer® 4P] button in the patient data management to start the Binoptometer® 4P program. The following dialog is displayed: ... - Page 36 9 Conducting an Examination The selected exam menu is displayed. Header with information about patients Arrow keys for steps: "back" and "next" Test pattern display Slider to adjust the test distance Input field "Comment" Display the exam program with test steps Buttons to change the size of the optotypes Arrow keys for "height adjustment"...
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Page 37: Display And Print Results
9 Conducting an Examination Display and Print Results You can view the test results. To do so, press this button You can display and print out details of the visual acuity test, the colour tests and the Amsler test. The respective settings must be activated for this purpose, see sec. -
Page 38: Load Existing Examination
9 Conducting an Examination Load Existing Examination You can load an existing examination, e.g. in order to print it out. If you are working with the OCULUS Patient Data Management, you can load an existing examination from there. Double click on the desired examination in the list of examinations, fig. -
Page 39: Turning Off
9 Conducting an Examination Turning Off Finish the current exam. Close the Binoptometer® 4P program. Shut down the computer. Turn off the Binoptometer® 4P with the On / Off switch. If you want to transport or store the Binoptometer® 4P after an exam, you must proceed in the proper manner. -
Page 40: Exporting Results Via The Patient Data Management
10 Exporting Results via the Patient Data Management 10 Exporting Results via the Patient Data Management Note: Risk of loss of data due to computer viruses Run a virus check before importing data from the USB stick. 10.1 Exporting Patient Data For example, patient and examination data can be exported for forwarding to another clinic. -
Page 41: Importing Patient Data
10 Exporting Results via the Patient Data Management To export the data, press the [Export] button (2). 10.2 Importing Patient Data If you receive patient data, for example, on a USB stick, you can import these data. To do this, the version of the Binoptometer® 4P program which you would like to import data into must match the version from which the data has been exported. -
Page 42: Cleaning, Disinfection And Maintenance
Have the Binoptometer® 4P checked every two years by our service department or an authorized dealer. If an error occurs that you can not resolve label the damaged Binoptometer® 4P as "out of order” and report the damage to OCULUS Service or your authorized dealer. ... -
Page 43: Disinfection
11 Cleaning, Disinfection and Maintenance Proceed as follows: Turn the Binoptometer® 4P off, sec. 9.8, page Unplug the power cord. When cleaning, use a damp cloth and make sure that no liquid enters the Binoptometer® 4P. Clean the plastic surfaces and painted surfaces with appropriate cleaning agents. -
Page 44: Care And Maintenance
If an error occurs that you can not resolve Label the damaged Binoptometer® 4P as "out of order”. Report the damage to OCULUS Service or your authorized dealer. Use only undamaged Binoptometer® 4P devices. 11.3.1 Forehead Rest Replacement... -
Page 45: Replacing The Fuse
11 Cleaning, Disinfection and Maintenance 11.3.2 Replacing the Fuse You can replace a blown fuse. Note: Function loss due to incorrect fuse Only use the fuse specified in the parts list (order 05100170). Turn the Binoptometer® 4P off, sec. -
Page 46: Transport And Storage
12 Transport and Storage 12 Transport and Storage Before storing or transporting the Binoptometer® 4P, you have to dismantle and pack it properly. 12.1 Disassembly and Packing Finish the current exam. Turn off the Binoptometer® 4P with the On / Off switch. ... -
Page 47: Transport And Storage
12 Transport and Storage 12.2 Transport and Storage Transport and storage conditions: Ambient temperature range -30°C to 70°C Relative humidity range 10% to 90%, Including condensation Air pressure range 500 hPa to 1060 hPa Wait approx. 3-4 hours after transport before operating the Binoptometer®... -
Page 48: Disposal
13 Disposal 13 Disposal In accordance with Guideline 2012/19/EG of the European Parliament and of the Council, and also the Law of the Federal Republic of Germany on the Commercialization, Recall and Environmentally Compatible Disposal of Electrical and Electronic Equipment, old electrical and electronic equipment must be sent out for recycling and may not be disposed in household trash. -
Page 49: Terms Of Warranty And Service
In general, our Business and Shipping Terms applicable on the date of purchase shall apply. 15.2 Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety, reliability and serviceability of the Binoptometer® 4P if the unit is used in compliance with the following terms: ... -
Page 50: Manufacturer And Service Address
This certification must contain the date of performance and statement of the performing firm, with signature. On request, and for this purpose, OCULUS will supply authorized persons with spare parts lists and additional descriptions. -
Page 51: Declaration Of Conformity
16 Declaration of Conformity 16 Declaration of Conformity Instruction Manual Binoptometer® 4P (G/59860/1016/en) 47 / 55... -
Page 52: Technical Data
17 Technical Data 17 Technical Data Test distances The viewing distance is adjustable from infinity to 30 cm (motorized). Viewer setting The viewer is infinitely adjustable up to approximately 35 ° looking down. Viewing height Optionally electrically adjustable, using either the rocker switch on the device or with the control unit or PC / Laptop / Netbook Operation... - Page 53 17 Technical Data Definition according to DIN EN 60601-1: Type of protection against electric shock Protection class 1 Degree of protection against electric shock Type B Housing protection class IP 20 Transport and Storage Conditions: Ambient temperature -30°C to +70°C Relative humidity, including condensation 10% to 90% Air pressure...
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Page 54: Appendix
Caution 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 Binoptometer® 4P. -
Page 55: Guidelines And Manufacturer's Declaration Electromagnetic Interference Emissions
Guidance and manufacturer´s declaration electromagentic emmissions IEC 60601-1-2, 5.2.2.1, table 1 The OCULUS Binoptometer® 4P is intended for operation in the electromagnetic environment specified below. The user of the Binoptometer® 4P should ensure that it is being used in such an environment. - Page 56 18 Appendix Guidance and manufacturer´s declaration electromagentic immunity, IEC 60601-1-2, 5.2.2.1, table 2 Immunity test IEC 60601 Compliance level Electromagnetic environment - test level guidlines Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be made of wood (ESD) ±...
- Page 57 18 Appendix Guidance and manufacturer´s declaration electromagentic immunity, IEC 60601-1-2, 5.2.2.2, table 4 Immunity test IEC 60601 Compliance level Electromagnetic environment - Guidelines test level Portable and mobile RF communications equipment should be used no closer to any part of Binoptometer® 4P, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 58 18 Appendix Recommended separation distances between portable and mobile RF communications equipment and the Binoptometer® 4P, IEC 60601-1-2, 5.2.2.2, table 6 The Binoptometer® 4P in intended for us e in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Binoptometer® 4P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters ) and the Binoptometer®...
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Page 59: Description Of The Connection
18 Appendix 18.3 Description of the Connection Binoptometer® 4P USB connection cable 025986000002 025986000004 025986000005 Computer/PC/laptop Mains connection Instruction Manual Binoptometer® 4P (G/59860/1016/en) 55 / 55... - Page 60 Manufacturer and Service Address Germany: USA: OCULUS Optikgeräte GmbH OCULUS, Inc. Münchholzhäuser Straße 29 17721 59th Avenue NE D 35582 Wetzlar Arlington Tel.: + 49 (0) 641-2005-0 WA 98223-1337 Fax: + 49 (0) 641-2005-255 Tel. +1 425-670-9977 E-mail: sales@oculus.de Fax +1 425-670-0742 www.oculus.de...
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