GM INSTRUMENTS ASRA User Manual Download Page 35

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Asra Curve User Guide V9

27/05/2021

Page

Appendix 1: Guidance on the Electromagnetic environment in which to operate
the instrument (cont

’

Guidance an

d 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.

Emission test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Class B

Mode 2

The equipment is suitable for use in a
professional healthcare facility environment only.

RF emissions

CISPR 11

Class B

Mode 2

The equipment is suitable for use in a professional
healthcare facility environment only.

Harmonic emissions

IEC61000-3-2

Class A

Mode 2

Voltage fluctuations / flicker
emissions

IEC61000-3-3

Plt
Pst
Dmax

Mode 2

Summary of Contents for ASRA

Page 1: ...Asra Curve User Guide V9 27 05 2021 Page 1 of 40 ASRA Curve Audiometer User Guide Version 9 ...

Page 2: ...7 4 The Home Screen Page 21 7 5 Selecting Audiometer Page 21 7 6 Tester Information Page 23 7 7 Patient Details Page 23 7 8 Find Patient Page 23 7 9 Comparison of Audiograms Page 24 8 Running Hearing Test 8 1 Automatic Operation Page 25 8 2 Manual Operation Page 25 8 3 Audiograms and HSE Categories Page 25 8 4 Printing Audiograms Page 27 8 5 Printing Referral Letters Page 27 9 Categorisation of Re...

Page 3: ...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 The contents of this document are provided as is Except as required by applicable law no warranties of any kind either expressed or i...

Page 4: ...s will be corrected at no cost to the purchaser within the first year except for shipping charges to and from the point of service This warranty does not apply to those parts that are subject to normal wear and tear such as cords ear cushions and headbands Replaceable parts which may deteriorate with use will be supplied at a reasonable cost The manufacturers warranty is void if the audiometer is ...

Page 5: ... the isolation transformer to ensure that the ASRA Curve is in compliance with BS EN 60601 Applied Parts The Applied Parts are the headset and the response button CAUTIONS Federal USA law restricts this device to sale by or on the order of a physician The use of the ASRA Curve near to sources of electromagnetic radiation such as mobile phones radio transmitters x ray equipment etc may prevent it f...

Page 6: ...onnect That may be sufficient but if not save any results close down the instrument software and restart it Servicing can only be carried out by GMI approved and authorised personnel No modifications are allowed 2 Technical Specification Factory trained personnel or engineers familiar with the standard EN 60601 can only undertake servicing of the ASRA Curve Audiometer Circuit diagrams will be made...

Page 7: ...nes presented at 100dB or above then a positive response from the operator is required Headset Earphones Cushions Audio cups TDH39P 10 Ohm impedance with MX41 AR Cushions and Amplivox AO22Audio cups Mechanical Dimensions 22x 23 x 4 cm Weight 1 Kg Calibration Frequency Annual calibration required by Manufacturer or Manufacturer approved provider Method ISO 8253 1 Calibration undertaken using Refere...

Page 8: ...t Input Socket Response Button Direct Current IEC 60417 5931 _ Mains Adaptor AC DC VEP15US09 For connected parts marked only connect the accessories supplied with the instrument These parts have been tested for use with the instrument for compliance to standards IEC 60601 1 and IEC 60601 1 2 Symbols used on labelling and packaging Symbol Meaning Location Manufacturer ISO 7000 3082 Instrument Label...

Page 9: ...y Action Sign ISO 7010 M001 Operating Manual Authorized Representative in the European Community Instrument Shipper Packing User Manual Address and Contact Details MANUFACTURED BY AUTHORIZED REPRESENTATIVE GM Instruments Ltd Advena Ltd Block 1 Annickbank Innovation Campus Tower Business Centre 2nd Flr Annick Road Tower Street Irvine Swatar KA11 4LF BKR 4013 UK Malta TEL 44 0 1294 554664 EMAIL enqu...

Page 10: ...udiologists The subject upon whom the hearing testing is performed is expected to be an employee working in high noise environments being screened in line with the Health and Safety Executive s regulations on noise at work or being routinely screened as a part of a workplace health programme Subsequently theycome from all walks of life and are of working age The ASRA Curve audiometer is expected t...

Page 11: ... in a folder called ASRA Curve If necessary the files can be transferred to a network drive Care should be taken in installations where a number of users have their own login to ensure that the two Asra programs are available to all who may need to use them When prompted Do you want to allow the following program from an unknown publisher to make changes to this computer click yes and continue In ...

Page 12: ...021 Page 12 of 40 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 ...

Page 13: ...hin the main program and then using Exit to save as the new default It is recommended that icons for ASRA Curve ASRA Curve testing program and Batch Processing Utility ASRA batch utility program be made available on each person s desktop To do this open the start menu and open the folder named ASRA Curve Next right click on the ASRA Curve program icon and select More followed by Open File Location...

Page 14: ...tch_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 In the setup window follow the instructions by click next to start the installation In the following window select acceptance and then next to confirm the License Agreement and continue ...

Page 15: ...Asra Curve User Guide V9 27 05 2021 Page 15 of 40 Once the installation has completed click on Finish then close down and restart your computer ...

Page 16: ...ooth is available connect the blue plug directly into the socket marked left Response button plug if a booth is used link the socket marked response on the back of Asra Curve to the black socket on the booth and connect the response button plug to the corresponding black socket inside the booth If no booth is available connect the response button plug directly into the socket marked response Opera...

Page 17: ...ld go out and the Response light should turn on and the message RESPONSE appears in the bottom righthand corner of the program window 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 ...

Page 18: ...he settings window and editing as required and then clicking the Save button 6 2 Save Storage Locations The default Active save and Passive storage locations are set in the program on installation These can be edited to any location on the 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 ...

Page 19: ...Test Settings The default settings for the hearing test are shown when the Hearing Test tab is selected and are shown below The menu allows the test frequencies tone duration starting intensity and side and either continuous or pulsed tones to be selected The default settings are Tone duration 1 5 seconds Starting Intensity 40dB Starting Side Left Test Frequencies 1 2 3 4 6 8 0 5 kHz Tone mode Con...

Page 20: ...as soon as they hear the tone The red audio cup goes on the right ear and the blue audio cup on the left ear Click on the Test button to start the test On completion compare the audiogram with the previously recorded audiogram for that artificial ear or test person It is always possible for any threshold point to move up or down by 5 dB but if almost all points are further down the audiogram from ...

Page 21: ...es which are provided in the program 7 4 The Home Screen The Home screen is the central point where the functions of the audiometer can be accessed Clicking on the Home icon at any time will return you to the Home screen From the Home screen you can create New records Search records Run Tests and Exit the program all by clicking on the associated icon Home Screen Additionally you can prepare the a...

Page 22: ...new calibration file Now click on Confirm Device Headset Use the Identify button to confirm that the audiometer is connected and functioning Click close to then return to the next screen Where a second headset has been calibrated to the audiometer the calibration will be saved onto the device memory and loaded by selecting the correct headphone serial numbers as above from either Slot 0 or Slot 1 ...

Page 23: ...ing the pencil symbol will open a window to enter the patients details as below In this you can enter the patients name employment ID number date of birth and gender The date of birth and gender must be entered correctly for the effective categorisation of resultant audiograms 7 8 Find Patient If a patient has previously been tested then by using the Search Record function on the Home Screen then ...

Page 24: ...rams tabs to view the previously generated data The Search Records tab will show all of the stored audiograms for the selected person If you want to view a particular audiogram select it and click on Open Test An example of a completed audiogram brought back from saved records is shown below 7 9 Comparison of Audiograms To compare the selected audiogram with another click the Compare Audiograms ta...

Page 25: ...nse of the best 2 out of 3 being taken as the threshold If there is no consistent response you will be notified by a message appearing on screen As the test proceeds the results will be plotted on the audiogram If at any point the test must be paused or stopped use the buttons provided on the interface Pressing Stop will stop the test but retain all results up to that point 8 2 Manual Operation To...

Page 26: ...tted at 100 dB HL maximum amplitude without operator intervention and the symbol includes an arrow pointing down This is shown above at 4 6 and 8 kHz on the left ear At the end of the test the HSE categories are automatically calculated and displayed in the Categorisation section at the bottom of the testing window along with and comments from analysis of the audiogram The operator can also add co...

Page 27: ...ith a print preview of the report including any related personnel and test data From this window you can choose to print the document to a selected printer save the document to file such as a PDF if a PDF printing utility is installed or zoom in and out of the document 8 5 Printing Referral Letters Supplied with the Asra Curve audiometer are letter templates based on HSE recommendations explaining...

Page 28: ...actitioner or to a hospital audiology clinic are made in cases of poor hearing when the thresholds are above the levels indicated in the Referral table below Warnings are given to the employee when the thresholds indicate mild hearing impairment as indicated in the H SE Warning table below These levels indicate that the employee s hearing is not as good as might be expected at his her age The warn...

Page 29: ...5th percentile i e hearing level normally experienced by 1 person in 20 Suggests significant NIHL Sum of hearing levels at 1 2 3 4 and 6 kHz Compare value with figure given for appropriate age band and gender in Table A1 Referral 4 Rapid Hearing Loss Reduction in hearing level of 30dB or more within 3 years or less Such a change could be caused by noise exposure or disease Sum of hearing levels at...

Page 30: ...play and USB Serial Port COM X under Ports and USB Serial Converter under Universal Serial Bus controllers headings b If the drivers have not been installed close the program down unplug the USB from the back of the Asra Curve The follow the instructions in the Installation section of this manual File Not Saved The audiogram has not been saved Is the folder and the path to it if saving over a netw...

Page 31: ...ents Headset positioning Remove glasses ear rings etc Place the headset so it sits comfortably on the head with the headband adjusted for best fit Patient cooperation Advise the patient to press and release the button as soon as they hear the tone A familiarisation facility is available when using the Single test button 12 Maintenance Technical Information The Asra audiometer should have its calib...

Page 32: ...hol based solution or cleaning wipes Do not allow liquid to run into theenclosure 14 2 Patient Contact Parts Must be cleaned with a Non Alcoholic wipe and care taken to prevent liquid build up The Earphone Cushions Audiocup cushions and the Response Button must be cleaned with a non alcoholic wipe Care should be taken to prevent the build up of liquid on the earphone Note The use of an alcohol bas...

Page 33: ...6 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 Microphone ASRA MICROPHONE Earphone cable ASRA OSICUS CORD Earphone Cushion Pair EARPHONE CUSHIONS Audiocup Cushion AUDIOCUP CUSHIONS Earphones TDH39 EARPHONE Audiocup Background Noise Reduction Headset ASRA OSICUS SR HEAD Carry Case ASRA ...

Page 34: ...igured and installed put into service in accordance with the instructions guidance provided herein and is used only in the configuration as supplied Changes or modifications to the ASRA Curve may result in increased emissions or decreased immunity of the instrument in relation to EMC performance The ASRA Curve should be used only with the cables accessories and transducers provided by GM Instrumen...

Page 35: ...r the user of the Asra should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Class B Mode 2 The equipment is suitable for use in a professional healthcare facility environment only RF emissions CISPR 11 Class B Mode 2 The equipment is suitable for use in a professional healthcare facility environment only Harmonic e...

Page 36: ...C Port 1 kV for input output lines N A No Signal Port 3m 100kHz repetition frequency Mains power quality should be that of a typical commercial or hospital environment Surge IEC610 00 4 5 0 5 kV and 1 kV line s to line s 0 5 kV 1 kV and 2 kV line s to earth N A No DC Port 0 5 kV and 1 kV line s to line s 0 5 kV 1 kV and 2 kV line s to earth N A No DC Port Mains power quality should be that of a ty...

Page 37: ...any partof the Asra including any cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separat...

Page 38: ...ification to this equipment is allowed The ASRA Curve Audiometer is powered by an external universal mains power module Power can be removed by unplugging the mains plug or by switching power off at the mains plug It complies with the specification for Class 1 ME equipment and can be used along with a PC and printer normally supplied by the customer NB the warning made earlier about the PC and pri...

Page 39: ...either read this manual or who has been trained by a competent authority in its use The power module provided with the ASRA Curve Audiometer VEP15US09 is considered to be part of the ME equipment The Headset and Response Button are considered to be the applied parts The equipment should be positioned to enable it to be disconnected from the mains supply quickly and easily Error Messages see Troubl...

Page 40: ...ill The only parts which are interchangeable by service personnel are the power module and the mains cable If these are changed a Medical Electrical Safety test to the current standard should be made prior to allowing release for use 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 d...

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