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Summary of Contents for GM INSTRUMENTS ASRA
- Page 1 ASRA Curve Audiometer User Guide Version 9 Asra Curve User Guide V9 27/05/2021 Page 1 of 40...
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Page 2: Table Of Contents
Patient Contact Parts Page 32 15. Supplied Parts Page 33 16. Spare Parts & Accessories Page 35 Appendix 1: Guidance on Electromagnetic Environment Page 34 Appendix 2: Technical Information Page 39 Asra Curve User Guide V9 27/05/2021 Page 2 of 40... - 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.
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Page 5: Important Safety Information
BS EN 60601, should be used to power the PC, printer, and the ASRA Curve. You must use the isolation transformer to ensure that the ASRA Curve is in compliance with BS EN 60601. -
Page 6: Technical Specification
Any incident, which results in actual or potential injury or death to a subject while using the ASRA Curve should be immediately communicated to GM Instruments at the address below. The ASRA Curve should only be connected to other mains powered devices such as computers and printers, which comply with EN 60950-1 and we also advise the use of a separating transformer. - Page 7 Please refer to pages 34 to 38 of this manual (Appendix 1) Service Life Safety and The service life of the ASRA Curve has been evaluated to be 10 Performance years from the date of manufacture. Additional Technical Information (relative to EN 60601-1:2006) is also provided in Appendix 2...
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Page 8: Symbols
3. Table of symbols used The following symbols appear on the ASRA Curve or the mains adaptor Symbol Meaning Socket Type Location Connected Part Refer to Instruction USB Type B Instrument Back Computer (Via Manual Panel USB Port) ISO 7010-M002 2.5mm DC Jack... - Page 9 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 Asra Curve User Guide V9 27/05/2021 Page 9 of 40...
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Page 10: Introduction
The ASRA Curve Audiometer is a medical device used to screen subjects for noise induced hearing loss. It is intended that the ASRA Curve 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 11: Installation
The Asra software and USB drivers are supplied on a USB drive and can be installed by inserting the USB drive into the computer, navigating to it, and right clicking on the file Asra.EXE, and Run as administrator. - Page 12 The next stage will prompt to create a shortcut to the Asra Curve program in the Start Menu folder, press Next to confirm. At the next stage, review the setting before clicking next and continuing with the installation. Asra Curve User Guide V9...
- Page 13 Click on Finish to complete the installation. The installation of the ASRA software is now complete. If it is necessary to change the default save and passive directory locations, this can be within the main program and then using Exit to save as the new default.
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Page 14: Installing The Drivers
Repeat the process for a folder called ASRA Osicus Batch_Utility to put the Batch_Utility shortcut onto the desktop. 5.2 ASRA Driver Installation To install the Asra Curve drivers, right click CDM21228_Setup.exe and select Run as Administrator. - Page 15 Once the installation has completed click on ‘Finish’, then close down and restart your computer. Asra Curve User Guide V9 27/05/2021 Page 15 of 40...
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Page 16: Installing The Hardware
The other connections on the back of Asra Curve, which are essential for its correct operation are:- • Power supply cable – check the LED on the front of Asra Curve to show that it is lit when mains power is switched on. •... - Page 17 Click on Stop to return to normal operation. • Click on print to check the operation of the printer. The system is now ready for use! Asra Curve User Guide V9 27/05/2021 Page 17 of 40...
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Page 18: Initial Setup
PC or a network location defined by the User. This can be changed by selecting the Settings tab on the home screen and then Storage in the new window. Asra Curve User Guide V9 27/05/2021... -
Page 19: Hearing Test Settings
• Test Frequencies – 1, 2, 3, 4, 6, 8, 0.5 kHz • Tone mode – Continuous Once changes have been made, select Save to confirm and set as default for testing. Asra Curve User Guide V9 27/05/2021 Page 19 of 40... -
Page 20: Calibration Check
(if a booth is being used), plus the jack connections at the back of the Asra should be cleaned with an alcohol wipe and swiped in and out 10 to 20 times to clean them. The test should then be repeated. If this does not restore the thresholds, then a cable problem might exist on the ear in question. -
Page 21: Introduction
The ASRA audiometer software if based on the Hughson-Westlake testing routine recommended by the British Society of Audiology. It has a number of additional features which combine to make Asra Curve a unique instrument, while still complying with the recommended procedures of the British Society of Audiology and the Health and Safety Executive. - Page 22 After calibration, you will be supplied with a file containing calibration information. To update the calibration information, press the Change button, browse to this file and click on Ok. Asra Curve User Guide V9 27/05/2021 Page 22 of 40...
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Page 23: Tester Information
If a patient has previously been tested then by using the Search Record function on the Home Screen then previous records can be searched by entering either the patients name or ID number. Asra Curve User Guide V9 27/05/2021 Page 23 of 40... -
Page 24: Comparison Of Audiograms
Highlight the one you want and then click on the Select button. Both will then be shown superimposed. And can be toggled on/off using the tick box at the side of the test window. Asra Curve User Guide V9 27/05/2021... -
Page 25: Running Hearing Test
8.3 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. Asra Curve User Guide V9 27/05/2021 Page 25 of 40... - Page 26 The operator can also add comments and notes to this section using the pencil button to open the dialogue box as shown below. These can relate to any observations during the test and will be printed on the audiograms. Asra Curve User Guide V9 27/05/2021 Page 26 of 40...
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Page 27: Printing Audiograms
8.5 Printing Referral Letters Supplied with the Asra Curve audiometer are letter templates based on HSE recommendations, explaining the resultant audiogram based on the category achieved. These can be printed by selecting the arrow next to the print icon and selecting Referral Letter. -
Page 28: Categorisation Of Results
Safety Executive (H&SE) categorisations for the current audiogram and display them in a similar way. The Asra Curve testing program uses the categorisation scheme which was introduced in the year 2006 by the H&SE, and this implementation is described here. - Page 29 These recommendations are followed in the Asra Curve 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.
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Page 30: Troubleshooting And Error Messages
The computer does not recognise the audiometer. A number of things to check that could cause this: 1. Is the Asra curve plugged in and getting power? The green power LED on the front panel will indicate whether it is powered up or not 2. -
Page 31: Factors Which Affect Absolute Accuracy
13. Calibration Annual calibration should be performed by an approved supplier, who has access to the ASRA Curve calibration software and whose equipment has been calibrated to traceable standards. -
Page 32: 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. Asra Curve User Guide V9 27/05/2021 Page 32 of 40... -
Page 33: Supplied Parts
AUDIOCUP CUSHIONS Earphones (TDH39) EARPHONE Audiocup Background Noise Reduction Headset ASRA/OSICUS/SR/HEAD Carry Case ASRA TRANSIT Power Supply Unit ASRA CURVE PSU EARS BOX – Electroacoustic Auto Response Unit AUTOTEST BOX Asra Curve User Guide V9 27/05/2021 Page 33 of 40... -
Page 34: Appendix 1: Guidance On Electromagnetic Environment
(including other medical devices). • The purpose of this testing is to ensure that the ASRA Curve 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 ASRA Curve. -
Page 35: Spare Parts & Accessories
(cont’d) Guidance and manufacturer’s declaration – electromagnetic emissions The Asra is intended for use in the electromagnetic environment specified below. The customer or the user of the Asra should assure that it is used in such an environment. - Page 36 (cont’d) Guidance and manufacturer’s declaration – electromagnetic immunity The Asra is intended for use in the electromagnetic environment specified below. The customer or the user of the Asra should assure that it is used in such an environment.
- Page 37 (cont’d) Guidance and manufacturer’s declaration – electromagnetic immunity The Asra is intended for use in the electromagnetic environment specified below. The customer or the user of the Asra should assure that it is used in such an environment.
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Page 38: Appendix 2: Technical Information
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 Asra is used exceeds the applicable RF compliance level above, the Asra should be observed to verify normal operation. If... - Page 39 • Error Messages --- see Troubleshooting section 10 • The ASRA Curve software can be closed by clicking on FILE and EXIT. The ASRA Curve hardware can be switched off by either of the following: o Removing the MAINS PLUG...
- Page 40 • Circuit diagrams, component lists and parts lists are available on request, along with email/telephone advice to service personnel trained and qualified to work on ME devices. Modification of the ASRA Curve Audiometer is not allowed. Asra Curve User Guide V9...
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