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GM INSTRUMENTS Osicus User Manual

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Osicus
Audiometer
User Guide
Version 8
Osicus User Guide V8
09/09/2021
Page 1 of 46

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  • Page 1 Osicus Audiometer User Guide Version 8 Osicus User Guide V8 09/09/2021 Page 1 of 46...

  • Page 2: Table Of Contents

    Contents 1. Osicus Audiometer Important Safety Information ............5 2. Technical Specification ....................8 3. Table of symbols used ..................... 10 4. Introduction ......................12 5. Installation ......................13 5.1 Osicus Program Installation ......................13 5.2 Osicus Driver Installation ......................... 18 5.3 Installing the Hardware ........................
  • Page 3 GM Instruments Limited reserves the right to make changes and improvements to any products described in this document without prior written notice. Under no circumstance shall GM Instruments be responsible for the loss of any data or income or any special, incidental, consequential, or indirect damages howsoever caused.
  • Page 4 Warranty This warranty is extended to the original purchaser of the audiometer by GM Instruments Ltd, through approved Distributors or through GM Instruments Ltd, and covers defects in materials of workmanship for a period of 1 year from the date of delivery to the original purchaser.

  • Page 5: Osicus Audiometer Important Safety Information

    BS EN 60601, should be used to power the PC, printer and the Osicus. You must use the isolation transformer to ensure that the Osicus is in compliance with BS EN 60601.
  • Page 6 BS EN 60601-1 MUST be used to ensure safety compliance, or run the PC on battery power without mains connection. Osicus User Guide V8 09/09/2021 Page 6 of 46...
  • Page 7 Federal (USA) law restricts this device to sale by or on the order of a physician. The use of the Osicus near to sources of electromagnetic radiation, such as mobile phones, radio transmitters, x-ray equipment etc, may prevent it from functioning correctly.

  • Page 8: Technical Specification

    2. Technical Specification No modification of this equipment is allowed. Factory-trained personnel or engineers familiar with the standard EN 60601 can only undertake servicing of the Osicus Audiometer. Circuit diagrams will be made available to competent persons on request. Medical CE The CE mark indicates that the device meets the requirement of Annex V &...
  • Page 9 Please refer to page 7 and Appendix 1 of this manual Service Life Safety and The service life of the Osicus has been evaluated to be 10 Performance years from the date of manufacture. * Additional Technical Information (relative to BS EN 60601-1) is also provided in...

  • Page 10: Table Of Symbols Used

    3. Table of symbols used The following symbols appear on the Osicus or the mains adaptor Symbol Meaning Socket Type Location Connected Part Refer to USB Type B Instrument Back Computer Instruction Manual Panel (Via USB Port) ISO 7010-M002 Type B...
  • Page 11 GM Instruments Ltd Advena Ltd Block 1 Annickbank Innovation Campus Tower Business Centre, 2 Annick Road Tower Street Irvine Swatar KA11 4LF BKR 4013 Malta TEL: +44 (0)1294 554664 EMAIL: enquiries@gm-instruments.com WEBSITE: www.gm-instruments.com Osicus User Guide V8 09/09/2021 Page 11 of 46...

  • Page 12: Introduction

    The Osicus Audiometer is a medical device used to screen subjects for noise induced hearing loss. It is intended that the Osicus will be used as part of a hearing screening program in industrial and corporate environments. The hearing screening will measure the hearing threshold of a test subject and indicate the need for further clinical analysis and treatment.

  • Page 13: Installation

    Osicus 2 Drivers Dotnetfx Manuals NB Do not connect Osicus to the PC until all program software and USB driver software installation has been completed. Software (Windows 10 and earlier) Open the folder Osicus Installation and click on setup.exe. Installation will begin unless the following problems are advised.
  • Page 14 If a version of Osicus has already been installed on your PC, you will be advised and the new installation will stop. Any previous versions of the software should be removed using the Add/ Remove Programs utility in the Control Panel, and then the Osicus installation program should be run again.
  • Page 15 Figure 2.1.3 Installing Window Figure 2.1.4 Installation Complete Window Osicus User Guide V8 09/09/2021 Page 15 of 46...
  • Page 16 Windows 7 & 8 automatically sets the folder in which the program settings are saved to be write protected. This results in the following error message upon exiting the Osicus Solo program. This will result in the settings you have selected in the Osicus Solo program not being saved for next time you use the program.
  • Page 17 Next, navigate back to the General tab of the Osicus Properties window. Uncheck the ‘Read Only (Only applies to files in this folder)’ button, press Apply and then OK. A confirmation window will then appear. Click OK. The Osicus solo program will now save your settings for the next time you use the program.

  • Page 18: Osicus Driver Installation

    To install the drivers open the ‘Osicus 2 Drivers’ folder on the USB drive supplied and click on USBdriver-amd64.exe to run the Device Driver Installation Wizard. A window may appear asking if you want to let the program make changes to your computer. Click yes.
  • Page 19 A second prompt will appear in the same place when the Osicus has enumerated the drivers, stating that the drivers were successfully installed for this device. This prompt may appear after a slight delay, the length of which will depend on how fast your computer runs.

  • Page 20: Installing The Hardware

    Switch - Response button plug – if a booth is used, link the socket marked response on the back of Osicus to the black socket on the booth and connect the response button plug to the corresponding black socket inside the booth.

  • Page 21: Check Installation

    In the Home Screen, click “Select Audiometer” and check that the audiometer and headphone serial numbers match with those connected • In the Osicus testing program Home Screen, select Perform Machine Checks, follow the instructions, and confirm the Osicus is functioning and receiving response correctly •...

  • Page 22: Preparing The System

    6. Preparing the System 6.1 Starting the program You will find an icon on your desktop and by clicking on START/All Programs, with the title Osicus Solo. Clicking on this will start the program. 6.2 Introducing the Home Screen The Home screen is the central point where the functions of the audiometer can be accessed.

  • Page 23: Perform Machine Checks

    6.4 Select Audiometer Viewing this screen allows you to check that you are using the correct audiometer/earphone combination and that the calibration file is up to date. Osicus User Guide V8 09/09/2021 Page 23 of 46...

  • Page 24: Settings

    Other test settings such as the frequencies tested, the tone characteristics, the threshold determination criteria and order of ear testing can all be altered from within this dialogue. Osicus User Guide V8 09/09/2021 Page 24 of 46...

  • Page 25: Tester Information

    ID Number:- Letters or numbers are accepted for entry, but as the content of this field is used as the unique identifier for the Asra Batch Utility software and Occupational Health Databases such as Opas or Cohort, it is important to enter this detail carefully. Osicus User Guide V8 09/09/2021 Page 25 of 46...

  • Page 26: Find Subject

    It can be done manually by clicking on browse or it can be done automatically by entering the Surname or an ID (Personnel) Number. An example of a search based on partial ID is shown below. Osicus User Guide V8 09/09/2021...
  • Page 27 Display Test or click on the Audiograms tab. An example of a completed audiogram, brought back from saved records is shown on the following page. Osicus User Guide V8 09/09/2021 Page 27 of 46...

  • Page 28: Comparison Of Audiograms

    7.4 Predictive Analysis Predictive Analysis is one of the unique features of the Asra Osicus software. Hearing test data can be analysed by intelligent algorithms and future hearing trends can be predicted. The predicted audiogram shows how the intelligent analysis thinks the subject’s audiogram will look in a year’s time.
  • Page 29 Osicus User Guide V8 09/09/2021 Page 29 of 46...

  • Page 30: Running Hearing Tests

    (if a booth is being used), plus the jack connections at the back of the Osicus should be cleaned with an alcohol wipe and swiped in and out 10 to 20 times to clean them.

  • Page 31: Automatic Operation

    British Society of Audiology. It has a number of additional features which combine to make Osicus a unique instrument, while still complying with the recommended procedures of the British Society of Audiology and the Health and Safety Executive. This section describes, among other things, the default settings in the program and the recommended steps in normal usage.

  • Page 32: Manual Operation

    8.6 Audiograms and HSE Categories Audiograms are the recognised method of displaying hearing test data. They are graphs showing the level at which the subject responded for each tone. Each ear is graphed separately. Osicus User Guide V8 09/09/2021 Page 32 of 46...

  • Page 33: Comparison Of Audiograms

    From this window you can choose to print the document to a selected printer, save the document to file or zoom in and out of the document. Osicus User Guide V8 09/09/2021 Page 33 of 46...

  • Page 34: Categorisation Of Results - H&Se Categories

    Safety Executive (H&SE) categorisations for the current audiogram, and display them in a similar way. The Osicus testing program uses the categorisation scheme which was introduced in the year 2006 by the H&SE, and this implementation is described here.
  • Page 35 These recommendations are followed in the Osicus program, where the four categories, as they are described on the screen, are as follows. Category Calculation Action 1 Acceptable Hearing Sum of hearing levels at 1, None Ability 2, 3, 4 and 6 kHz.

  • Page 36: Troubleshooting And Error Messages

    Use “Select Audiometer” from the home screen to search for the calibration file, it will typically be called ZZZ_YY.txt, where ZZZ is the serial number of the Osicus and YY is the year it was last calibrated. When found, select the file and press OK.

  • Page 37: Factors Which Affect Absolute Accuracy

    13. Calibration Annual calibration should be performed by an approved supplier, who has access to the Osicus calibration software and whose equipment has been calibrated to traceable standards.

  • Page 38: Cleaning

    Care should be taken to prevent the build-up of liquid on the earphone. Note: The use of an alcohol based wipe has the effect of spreading, and therefore changing the profile of, the earphone cushions. Osicus User Guide V8 09/09/2021 Page 38 of 46...

  • Page 39: Supplied Parts

    Calibration certificate 16. Spare Parts and Consumables Additional consumables or spare parts can be ordered against the codes below Item Part No Response Button Unit ASRA/OSICUS P R BUT Earphone cable ASRA/OSICUS CORD Earphone Cushion (Pair) EARPHONE CUSHIONS Audiocup Cushion...

  • Page 40: Appendix 1: Guidance On The Electromagnetic Environment In Which To Operate The Instrument

    (including other medical devices). The purpose of this testing is to ensure that the Osicus is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the essential operation of the Osicus.
  • Page 41 IEC61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The Osicus is intended for use in the electromagnetic environment specified below. The customer or the user of the Osicus should assure that it is used in such an environment. Immunity test...
  • Page 42 (cont) Guidance and manufacturer’s declaration – electromagnetic immunity The Osicus is intended for use in the electromagnetic environment specified below. The customer or the user of the Osicus should assure that it is used in such an environment.
  • Page 43 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Osicus is used exceeds the applicable RF compliance level above, the Osicus should be observed to verify normal operation. If...

  • Page 44: Appendix 2: Technical Information (Relative To En 60601-1:2006+A12:2014)

    No modification to this equipment is allowed. 6.2 The Osicus Audiometer is powered from a laptop or PC via the supplied USB cable. Power can be removed by unplugging the USB cable from either the PC/laptop or the back of the Osicus.
  • Page 45 7.9.2.1 The Osicus Audiometer health care professional or competent person in medical environment, i.e. hospital, clinic. 7.9.2.3 The Osicus power is intended to receive power via a USB connection with a ISO 60950 compliant laptop/PC. The combination is considered to be an ME SYSTEM.
  • Page 46 / desktop PC are used in the non-patient environment Connect only items that have been specified as part of, or specified as being compatible with the Osicus Audiometer. Supplied and compatible spare parts and accessories are listed in Section 15 & 16 of this manual.

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