AmpliVox 116 Operation Manual
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AmpliVox 116 Operation Manual

Manual screening audiometer
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Model 116
Operation Manual
OM006-12 Model 116 Operating Manual
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Summary of Contents for AmpliVox 116

  • Page 1 Model 116 Operation Manual OM006-12 Model 116 Operating Manual Page 1...

  • Page 2: About This Manual

    ABOUT THIS MANUAL READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT. This manual is valid for the Model 116 (applies from firmware version 4v47 onwards – please refer to section 1.3). This product is manufactured by: Amplivox Ltd.
  • Page 3 For supply in US only Caution: Federal Law restricts this device to sale by or on the order of a licenced medical professional.
  • Page 4 Contents 1 Introduction 1.1 Intended applications 1.2 Unpacking 1.3 Firmware version 1.4 Standard contents 1.5 Optional accessories 2 Important Safety Instructions 2.1 Precautions 2.2 Electromagnetic compatibility (EMC) considerations 2.3 Power supply options 2.4 Audiometer connections 2.5 Data transfer to a printer 2.6 Data transfer to a computer 3 Using the Audiometer 3.1 Switching the audiometer on and off...

  • Page 5: Introduction

    1 Introduction Thank you for purchasing an Amplivox audiometer. The Amplivox Model 116 is a manual screening audiometer that will give many years of reliable service if treated with care. 1.1 Intended applications The Model 116 screening audiometer is designed for use by general practitioners, occupational health staff and child health professionals and is the ideal instrument for primary care groups, schools and industry.

  • Page 6: Optional Accessories

    Printer(s) Printer cable(s) Audiocups (noise reducing earphone enclosures) 2 Important Safety Instructions The Model 116 instrument must be used only by practitioners qualified to perform audiometric tests. It is intended for use as a screening tool. 2.1 Precautions READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE...

  • Page 7: Electromagnetic Compatibility (Emc) Considerations

    Any test results will be automatically saved. The display will show “Low Batt” when the battery voltage is low. It is advisable to change the batteries as soon as this happens. Once the OM006-12 Model 116 Operating Manual Page 3...

  • Page 8: Audiometer Connections

    The mains adapter is the mains disconnect device and therefore the audiometer should be positioned such that easy access to the mains adapter is possible. If a replacement mains adapter is required, please contact Amplivox or your Amplivox distributor. 2.4 Audiometer connections...

  • Page 9: Data Transfer To A Printer

    The relevant part numbers are indicated in Section 12 Note regarding the 6-pin mini DIN connector: This is a restricted socket for Amplivox use only. No user access is permitted. For connected parts marked * only connect the accessories supplied with the instrument or supplied by Amplivox or an Amplivox distributor.

  • Page 10: Using The Audiometer

    Several keys on the audiometer have different functions depending on the actual mode of operation. These are MENU (OFF), LEFT (NO), RIGHT (YES) and FREQUENCY   (MENU SELECT). The use of these keys is described below. Page 6 OM006-12 Model 116 Operating Manual...
  • Page 11 (see Section 3.5.1) RIGHT Press once to select the right ear (the indicator above the key illuminates green); if the right ear OM006-12 Model 116 Operating Manual Page 7...
  • Page 12 Hold this key to interrupt the test and route the operator’s voice from the front panel microphone to the headset; the level is  adjusted with the SIGNAL keys; when the key is released the output levels return to their default values Page 8 OM006-12 Model 116 Operating Manual...

  • Page 13: Threshold Retention Function

    The recorded values for the left and right ears are shown on the lower line of the display as illustrated below. SIGNAL dBHL FREQUENCY Hz 30dB 4kHz This display shows thresholds at 4kHz THRESHOLDS Left ear 20dBHL Right ear 10dBHL OM006-12 Model 116 Operating Manual Page 9...

  • Page 14: Printing Audiograms

    3.6 Printing audiograms Two designated thermal printers (the Able AP1300 or the Sanibel MPT-II) are available as options for use with the Model 116 audiometer. The correct printer must be selected (use the MENU options described in Section 3.4.2 to make this selection).
  • Page 15 The patient should be given the following instructions using the TALKOVER function:  “As soon as you hear the tone, press the response switch. When you no longer hear the tone release the response switch” 4.5 Pre-test OM006-12 Model 116 Operating Manual Page 11...
  • Page 16 (5) Repeat step 4 until the patient responds three out of a maximum of five times at the same signal level. This indicates the patient’s hearing Page 12 OM006-12 Model 116 Operating Manual...

  • Page 17: Specification

    Output level accuracy: Within 3dB Output level step size: Output transducer: DD45 earphones (supplied) Tone present: Single, warble or pulsed Communication: Integral talk over facility USB interface: Transfer of test results to a computer OM006-12 Model 116 Operating Manual Page 13...

  • Page 18: Maximum Hearing Levels Provided At Each Frequency

    Mode of operation Continuous operation Equipment mobility Portable The Model 116 Audiometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive. It is intended for use as a screening audiometer instrument. Page 14...

  • Page 19: Symbols

    Expected battery life: 6 to 8 hours use from alkaline batteries Frequency Modulation Carrier frequencies: 125Hz to 8kHz as per pure tones Modulation waveform: Sinusoidal Rising and falling symmetry: Symmetrical on linear frequency scale OM006-12 Model 116 Operating Manual Page 15...

  • Page 20: Routine Maintenance

    8 Routine Maintenance 8.1 Audiometer maintenance The Model 116 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 21: Transducer 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.

  • Page 22: Instrument Storage And Transportation

    10% to 90% (non-condensing) Atmospheric Pressure: 500 hPa to 1060 hPa 10 Calibration and Repair of the Instrument Amplivox recommends that this audiometer should be calibrated on an annual basis. Please contact Amplivox or the designated distributor for details of calibration services. Refer to ISO 8253-1 for additional guidance.

  • Page 23: 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 24: Disposal Information

     bear the crossed out wheeled bin symbol with black bar underneath  or, have been replaced with new Amplivox products on a like-for-like basis please contact our WEEE Compliance Scheme using the details below. B2B Compliance will be able to provide further information on how to recycle your waste electrical units and answer any queries you may have.

  • Page 25: Appendix 1 - Emc Guidance & Manufacturer's Declaration

    Declaration Guidance and manufacturer’s declaration – electromagnetic emissions The Model 116 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of Model 116 Audiometer should assure that it is used in such an environment.
  • Page 26 Guidance and manufacturer’s declaration – electromagnetic immunity (1) The Model 116 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 116 Audiometer should assure that it is used in such an environment.
  • Page 27 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 OM006-12 Model 116 Operating Manual Page 23...
  • Page 28 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Model 116 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 116 Audiometer should assure that it is used in such an environment.
  • Page 29 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 116 Audiometer is used exceeds the applicable RF compliance level above, the Model 116 Audiometer should be observed to verify normal operation.
  • Page 30 Recommended separation distances between portable and mobile RF communications equipment and the Model 116 Audiometer The Model 116 Audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 116 Audiometer can help prevent electromagnetic...

  • Page 31: Appendix 2 - Use With Non-Medical Electrical Equipment

    16 of IEC 60601-1:2005 are met. The following signal inputs and outputs on the Model 116 audiometer are electrically isolated to the requirements of IEC 60601-1 in order to reduce any potential hazard associated with the use of mains-powered equipment...
  • Page 32 Diagram 1: Model 116 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter Model 116 Audiometer Page 28 OM006-12 Model 116 Operating Manual...
  • Page 33 Diagram 2: Model 116 used with the medically-approved mains adapter and printer Mains Outlet Medical Mains Adapter Model 116 Audiometer Mains Outlet Printer via PRINTER Printer S socket Power Supply OM006-12 Model 116 Operating Manual Page 29...
  • Page 34 Diagram 3: Model 116 used with the medically-approved mains adapter and PC Mains Outlet Medical Mains Adapter Model 116 Audiometer Mains Outlet Power Supply via USB socket Page 30 OM006-12 Model 116 Operating Manual...

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