AmpliVox 260 Operating Manual
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AmpliVox 260 Operating Manual

Diagnostic audiometer
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Amplivox Model 260
Diagnostic Audiometer

Operating Manual

(Applies from serial number 12790 onwards)
Amplivox Ltd
29-30 Station Approach
Kidlington
Oxford OX5 1JD
ENGLAND
Tel: +44 (0)1865 842411
Fax: +44 (0)1865 841853
sales@amplivox.ltd.uk
www.amplivox.ltd.uk

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  • Page 1: Operating Manual

    Amplivox Model 260 Diagnostic Audiometer Operating Manual (Applies from serial number 12790 onwards) Amplivox Ltd 29-30 Station Approach Kidlington Oxford OX5 1JD ENGLAND Tel: +44 (0)1865 842411 Fax: +44 (0)1865 841853 sales@amplivox.ltd.uk www.amplivox.ltd.uk...

  • Page 3: Table Of Contents

    Contents 1 Introduction 1.1 Intended applications 1.2 Unpacking 1.3 Warranty card (UK customers only) 1.4 Standard contents 1.5 Optional accessories 2 Important Safety Instructions 2.1 Precautions 2.3 Mains supply operation 2.4 Audiometer connections 2.5 Data transfer to a printer 2.6 Data transfer to a computer 2.7 Line in/out connection (audio) 3 Using the Audiometer 3.1 Switching the audiometer on and off...
  • Page 4 Page 2 OM023-4 Amplivox 260 Operating Manual...

  • Page 5: Introduction

    1 Introduction Thank you for purchasing an Amplivox audiometer. The Amplivox Model 260 is a diagnostic audiometer that will give many years of reliable service if treated with care. 1.1 Intended applications The Amplivox Model 260 diagnostic audiometer is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals.

  • Page 6: Optional Accessories

    Data cable for NOAH Audiocups (noise reducing earphone enclosures) 2 Important Safety Instructions The Amplivox Model 260 instrument must be used only by practitioners qualified to perform audiometric tests. It is intended for use as a screening and diagnostic tool.

  • Page 7: Mains Supply Operation

    The audiometer is designed for continuous operation and is powered by a mains adapter which is supplied, and specified as part of the equipment. If a replacement is required, please contact your Amplivox distributor. All other connections must be made before connecting the output lead from the adapter into the POWER input socket on the back of the audiometer.

  • Page 8: Audiometer Connections

    Amplivox or an Amplivox distributor. These parts have been tested for use with the Amplivox Model 260 Diagnostic Audiometer for compliance with the standards IEC 60601-1 and IEC 60601-1-2. The use of accessories other than those specified may compromise compliance with these standards.

  • Page 9: Data Transfer To A Computer

    Please refer to Appendix 4 for important information regarding the connection of non-medical electrical equipment to medical electrical equipment The Amplivox Model 260 has audio line in/out connections for CD or tape player input (e.g. for recorded speech testing) and amplifier output. Important Note: Line out connections are switched on only when FREFIELD is selected.

  • Page 10: Testing The Patient Response Switch

    Several keys on the audiometer have different functions depending on the actual mode of operation. These are ON/OFF (MENU), LEFT (NO), RIGHT (YES) and FREQUENCY   (MENU SELECT). The use of these keys is described below. Page 8 OM023-4 Amplivox 260 Operating Manual...
  • Page 11 FF equiv. speech?: This option is only available if either DD45 or TDH39 is the selected headphone; if activated, free-field equivalent levels will output to the headphone in speech mode (see Appendix 1) OM023-4 Amplivox 260 Operating Manual Page 9...
  • Page 12 CONSTANT This switches tone or speech signal on continuously; the indicator above the key illuminates green; it may be interrupted by pressing the PRESENT key Page 10 OM023-4 Amplivox 260 Operating Manual...
  • Page 13 Press once to select the right ear; the indicator above the key illuminates green ; if the right ear is already selected press again to store the displayed signal value as a threshold (or a ULL if this has been selected) OM023-4 Amplivox 260 Operating Manual Page 11...
  • Page 14 Use the  SIGNAL keys to adjust the left channel  level and the MASKING keys to adjust the right. Pressing the PRESENT key interrupts the signal presented. THL/ULL: Manual audiometry Page 12 OM023-4 Amplivox 260 Operating Manual...

  • Page 15: Threshold Retention Function

    MENU key, press FREQUENCY  to 1” appears on screen. Use the SIGNAL keys to select a location numbered 1-12, and then press the YES key. Release the MENU key once confirmation appears on the display. OM023-4 Amplivox 260 Operating Manual Page 13...

  • Page 16: Loading Audiograms From Internal Memory

    3.8 Printing audiograms Two designated thermal printers (the Able AP1300 or the Martel MCP8830) are available as options for use with the Amplivox Model 260 audiometer. The correct printer must be selected (use the MENU options described in Section 3.4.2 to make this selection).

  • Page 17: Suggested Sequence Of Operation And Test Procedure

    The headset or appropriate transducer must be fitted by a qualified person to ensure a proper seal and a comfortable fit. The leads from the headset are connected to the instrument and the headset is then fitted to the patient. OM023-4 Amplivox 260 Operating Manual Page 15...
  • Page 18 2 out of a maximum of 3 times at the same signal level; this will automatically display the threshold on the screen (13) Proceed to the next test frequency and repeat steps 7 to 13 (14) Repeat steps 7 to 14 for the other ear Page 16 OM023-4 Amplivox 260 Operating Manual...

  • Page 19: Specification

    Integral talk over and talk back facility Recorded speech: Tape or CD input Live speech: 1 x microphone input Monitoring indicator: VU - (to IEC 60268-17; ANSI S3.6:2004) NOAH interface: Transfer of AC, BC & ULL test results OM023-4 Amplivox 260 Operating Manual Page 17...

  • Page 20: Maximum Hearing Levels Provided At Each Frequency

    Mode of operation Continuous operation Equipment mobility Portable The Model 260 Audiometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive. It is intended for use as a diagnostic audiometer instrument. Page 18...

  • Page 21: Symbols

    BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions. OM023-4 Amplivox 260 Operating Manual Page 19...

  • Page 22: Technical Information

    Static headband force: Headphones: 4.5N Bone vibrator: 5.4N Bone vibrator calibrated: For mastoid placement & unoccluded test ear Sound attenuation characteristics: ISO8253-1, Table 3 Airborne sound from bone vibrator: See Br. J. Audiol. 1980, P73-75 Page 20 OM023-4 Amplivox 260 Operating Manual...

  • Page 23: Routine Maintenance

    8 Routine Maintenance 8.1 Audiometer maintenance The Amplivox Model 260 audiometer is a precision instrument. Handle it carefully in order to ensure its continued accuracy and service. When cleaning the instrument, first disconnect it from the mains supply. Use a soft cloth and mild detergent to clean the instrument panel when required.
  • Page 24  Roll the foam eartip into the smallest possible diameter  Insert the eartip into the ear canal of the patient Page 22 OM023-4 Amplivox 260 Operating Manual...

  • Page 25: Mains Adapter Maintenance

    8.3 Mains adapter maintenance Before use, check the mains AC adapter for signs of wear and/or damage. If you find any replace the adapter immediately by contacting Amplivox or your Amplivox distributor. Refer to Section 12 for approved part numbers DO NOT USE ANY OTHER TYPE OF MAINS ADAPTER WITH THIS INSTRUMENT.

  • Page 26: Guarantee

    The instrument will be repaired free of charge for a period of one year from the date of despatch if returned, carriage paid, to the Amplivox service department. Return carriage is free of charge for customers in the UK and chargeable for overseas customers.

  • Page 27: Ordering Consumables And Accessories

    12 Ordering Consumables and Accessories To order consumables, additional accessories and to replace detachable parts that have been damaged, please contact Amplivox for current prices and delivery charges. The items available are listed below: Stock No. Description A022 Audiocups (noise reducing earphone enclosures)
  • Page 28 Shipping documentation will reference the stock number quoted above, and images of the parts alongside the relevant stock number are available on the Amplivox/Amplivox website (www.amplivox.ltd.uk). The required fitting instructions are supplied with each part. Page 26...

  • Page 29: Appendix 1 - Speech Audiometry

    Appendix 1 - Speech Audiometry The Amplivox Model 260 audiometer may be used in the following speech modes of operation. However users should be aware that there is a growing body of professional opinion that Live Voice speech audiometry is generally not recommended.
  • Page 30 INT is now displayed indicating that internal masking is selected (Note: External masking is not available when MIC is selected) c) Speech-weighted masking is now routed to the opposite earphone to that selected Page 28 OM023-4 Amplivox 260 Operating Manual...
  • Page 31 CONSTANT key (the LED will extinguish) and use the PRESENT key while presenting the test material A1.3.2 Procedure: As described in A1.1.2 except that the operator plays the recorded material to the subject. OM023-4 Amplivox 260 Operating Manual Page 29...
  • Page 32 Connect a microphone to the MIC1 input on the audiometer c) Press SPEECH repeatedly to ensure that ‘MIC’ is displayed in capitals at the bottom left of the display (indicating that the external microphone is selected) d) Press the FREEFIELD key Page 30 OM023-4 Amplivox 260 Operating Manual...
  • Page 33 Ensure that INT is displayed in capitals indicating that the audiometer- generated noise is selected; if necessary press the MASK key until INT is displayed in capitals c) Speech-weighted noise is routed to the competing LINE OUT channel OM023-4 Amplivox 260 Operating Manual Page 31...
  • Page 34 Use the SIGNAL keys to adjust the signal channel and the  MASKING keys to adjust the noise channel A1.8.2 Procedure: As described in A1.3.2 but adjusting the competing noise level as required. Page 32 OM023-4 Amplivox 260 Operating Manual...

  • Page 35: Appendix 2 - Free Field Calibration Procedure

    Assurance of Calibration The following is a brief description of the equipment and procedures to be used with the Amplivox Model 260 audiometer as a means of performing free-field calibration. However it must be emphasised that it is the responsibility of the equipment operator to ensure that correct free-field calibration has been achieved, and it is recommended that the standards for free-field &...
  • Page 36 90dBSPL as measured by the SLM at the reference point. The response should then be checked to be within the following limits (IEC 60645-2:1993 Section 10.1): Page 34 OM023-4 Amplivox 260 Operating Manual...
  • Page 37 OM023-4 Amplivox 260 Operating Manual Page 35...
  • Page 38 SIGNAL keys to reach the correct level as measured by the SLM  Repeat the above until all frequencies have been calibrated for the Left channel Page 36 OM023-4 Amplivox 260 Operating Manual...
  • Page 39 If necessary it is possible to switch between speech (competing noise) and warble calibration modes by pressing the SPEECH key again  To store the levels and leave Free-field calibration mode, press the MENU key OM023-4 Amplivox 260 Operating Manual Page 37...
  • Page 40 SLM reads 90dBSPL at the listening point with a 70dBHL setting on the instrument; note that this is an approximate setting only, as it is not possible to produce a true calibration signal in live speech Page 38 OM023-4 Amplivox 260 Operating Manual...

  • Page 41: Appendix 3 - Emc Guidance & Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The Amplivox Model 260 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of Model 260 Audiometer should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 42 Guidance and manufacturer’s declaration – electromagnetic immunity (1) The Amplivox Model 260 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 260 Audiometer should assure that it is used in such an environment.
  • Page 43 IEC 61000-4-8 typical location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to the application of the test level OM023-4 Amplivox 260 Operating Manual Page 41...
  • Page 44 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Amplivox Model 260 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 260 Audiometer should assure that it is used in such an environment.
  • Page 45 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 260 Audiometer is used exceeds the applicable RF compliance level above, the Model 260 Audiometer should be observed to verify normal operation.
  • Page 46 Recommended separation distances between portable and mobile RF communications equipment and the Model 260 Audiometer The Amplivox Model 260 Audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 260 Audiometer can help prevent electromagnetic...

  • Page 47: Appendix 4 - Use With Non-Medical Electrical Equipment

    16 of IEC 60601-1:2005 are met. The following signal inputs and outputs on the Amplivox Model 260 audiometer are electrically isolated to the requirements of IEC 60601-1 in order to reduce any potential hazard associated with the use of mains-...
  • Page 48 Diagram 1: Model 260 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter Model 260 Audiometer Page 46 OM023-4 Amplivox 260 Operating Manual...
  • Page 49 Diagram 2: Model 260 used with the medically-approved mains adapter and printer Mains Outlet Medical Mains Adapter Model 260 Audiometer Mains Outlet Printer Printer via DATA socket Power Supply OM023-4 Amplivox 260 Operating Manual Page 47...
  • Page 50 Diagram 3: Model 260 used with the medically-approved mains adapter and PC Mains Outlet Medical Mains Adapter Model 260 Audiometer Mains Outlet Power Supply via USB socket Page 48 OM023-4 Amplivox 260 Operating Manual...
  • Page 51 Diagram 4: Model 260 used with the medically-approved mains adapter and CD/Tape player Mains Outlet Medical Mains Adapter Model 260 Audiometer Mains Outlet CD/Tape Player via Line In Socket OM023-4 Amplivox 260 Operating Manual Page 49...
  • Page 52 Diagram 5: Model 260 used with the medically-approved mains adapter and external amplifier Mains Outlet Medical Mains Adapter Model 260 Audiometer Mains Outlet Amplifier via Line Out Socket Page 50 OM023-4 Amplivox 260 Operating Manual...

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