AmpliVox 170 Operation Manual
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AmpliVox 170 Operation Manual

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Model 170
Operation Manual

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  • Page 1 Model 170 Operation Manual...

  • 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 170 (applies from firmware version 2N22 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 5: Table Of Contents

    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 Mains supply operation 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 7: Introduction

    1 Introduction Thank you for purchasing an Amplivox audiometer. The Amplivox Model 170 is an automatic screening audiometer that will give many years of reliable service if treated with care. 1.1 Intended applications The Model 170 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 8: Standard Contents

    Printer(s) Printer cable(s) Audiocups (noise reducing earphone enclosures) 2 Important Safety Instructions The Model 170 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 9: Electromagnetic Compatibility (Emc) Considerations

    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 10: Audiometer Connections

    6 pin mini DIN Reserved port; Amplivox diagnostic use only below POWER 2.5mm power jack Mains AC/DC Adapter * RESPONSE 6.3mm jack Black Patient Response Switch * The relevant part numbers are indicated in Section 12 D-0115687-C (OM008) – 170 Operating Manual...

  • Page 11: Data Transfer To A Printer

    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. These parts...

  • Page 12: Using The Audiometer

    Several keys on the audiometer have different functions depending on the actual mode of operation. These are MENU (OFF), PRINT (RESET), LEFT (NO), RIGHT (YES), AUTO (RESULTS) and FREQUENCY   (MENU SELECT). The use of these keys is described below. D-0115687-C (OM008) – 170 Operating Manual...
  • Page 13 Press YES to include 1.5kHz in an automatic test or NO to exclude from the test Use 8KHz in auto?: Press YES to include 8kHz in an automatic test or NO to exclude from the test D-0115687-C (OM008) – 170 Operating Manual...
  • Page 14 20dB higher output in manual test mode;  press the key and then use SIGNAL access the extra 20dB in 5dB steps; an indicator above the key is used to show that the function is active D-0115687-C (OM008) – 170 Operating Manual...
  • Page 15  and the key to select a higher frequency PRESENT Press to present the displayed test signal to the patient. The “PRESENT” indicator above the display will be illuminated green during tone presentation. D-0115687-C (OM008) – 170 Operating Manual...

  • Page 16: Threshold Retention Function

    SIGNAL dBHL FREQUENCY Hz 30dB 4kHz This display shows thresholds at 4kHz THRESHOLDS Left ear 20dBHL Right ear 10dBHL To clear the Threshold Retention memory, use the Clear Test menu option described in Section 3.4.2. D-0115687-C (OM008) – 170 Operating Manual...

  • Page 17: Saving Audiograms In Internal Memory

    3.8 Printing audiograms Two designated thermal printers (the Able AP1300 or the Sanibel MPT-II) are available as options for use with the Model 170 audiometer. The correct printer must be selected (use the MENU options described in Section 3.4.2 to make this selection).

  • Page 18: Data Transfer To Audibase Or Audiview

    3.9 Data transfer to Audibase or AudiView Test results stored within the audiometer may be transferred to the Amplivox Audibase database which is available as an option and must be installed on to a computer (see Section 12 for the part number). Alternatively, Amplivox AudiView allows data to be transferred to a computer and subsequently viewed, annotated &...

  • Page 19: Test System Arrangement

    (4) If the automatic Threshold Retention Function is required ensure that the Store on 2 of 3 option is enabled (see Section 3.4.2) and that a patient response switch is in use (5) Prepare the test environment & patient (see Sections 4.1 to 4.3) D-0115687-C (OM008) – 170 Operating Manual...
  • Page 20 5dB steps until the patient responds (4) If the patient does not respond, increase the signal level in 5dB steps until there is a response and then continue with step 4. D-0115687-C (OM008) – 170 Operating Manual...

  • Page 21: Automatic Audiometry

    (3) Use the following MENU options (see Section 3.4.2) to adjust the automatic test settings as required.  Use 250Hz in auto?  Use 1K5Hz in auto?  Use 8KHz in auto?  Use familiarisation?  2 of 3 in auto? D-0115687-C (OM008) – 170 Operating Manual...
  • Page 22 (250Hz, 1.5kHz or 8kHz). The test may be cancelled at any time by pressing the RESET key; any thresholds already established will be retained unless cleared or overwritten. D-0115687-C (OM008) – 170 Operating Manual...
  • Page 23 If required the operator may then add or modify automatically-generated thresholds using manual audiometry (see Section 4.4) The thresholds are retained by the audiometer and may be viewed, stored, printed or transferred to a computer as described in Section 4.4.4. D-0115687-C (OM008) – 170 Operating Manual...
  • Page 24 This occurs if the audiometer was unable to record a threshold at one or more frequencies (e.g. if no response was made and the retry option was not chosen). The operator then has the option to use manual audiometry to obtain any missing thresholds. D-0115687-C (OM008) – 170 Operating Manual...

  • Page 25: Specification

    100-240Vac; 50/60Hz; 0.4A Dimensions: 270mm long x 175mm deep x 68mm high Weight: 0.75kg (approx) Safety: IEC 60601-1 (plus UL, CSA & EN deviations) EMC: IEC 60601-1-2 CE mark: To the EU Medical Device Directive D-0115687-C (OM008) – 170 Operating Manual...

  • Page 26: Symbols

    Mode of operation Continuous operation Equipment mobility Portable The Model 170 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. 6 Symbols The following symbols appear on the audiometer or mains adapter: Definition: Refer to instruction manual (mandatory).

  • Page 27: Technical Information

    Input / Output Power input: 2.5mm barrel-type socket. Patient response input: 6.3mm Jack socket Left & Right outputs: 6.3mm Jack socket USB: Type B socket Printer: RJ12 socket (6-way) Maximum voltage at any output: 12V peak D-0115687-C (OM008) – 170 Operating Manual...

  • Page 28: Routine Maintenance

    8 Routine Maintenance 8.1 Audiometer maintenance The Model 170 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 29: 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.

  • Page 30: Guarantee

    The instrument will be repaired free of charge for a period of two years 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 31: 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 32: 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 33: Appendix 1 - Emc Guidance & Manufacturer's Declaration

    Appendix 1 - EMC Guidance & Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic emissions The Model 170 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of Model 170 Audiometer should assure that it is used in such an environment.
  • Page 34 Guidance and manufacturer’s declaration – electromagnetic immunity (1) The Model 170 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 170 Audiometer should assure that it is used in such an environment.
  • Page 35 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 D-0115687-C (OM008) – 170 Operating Manual...
  • Page 36 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Model 170 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 170 Audiometer should assure that it is used in such an environment.
  • Page 37 NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. D-0115687-C (OM008) – 170 Operating Manual...
  • Page 38 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 170 Audiometer is used exceeds the applicable RF compliance level above, the Model 170 Audiometer should be observed to verify normal operation.
  • Page 39 Recommended separation distances between portable and mobile RF communications equipment and the Model 170 Audiometer The Model 170 Audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 170 Audiometer can help prevent electromagnetic...

  • Page 40: 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 170 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 41 Refer to Diagrams 1 to 3 below for typical configurations of connected peripheral equipment. Refer to Amplivox Limited at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment. Diagram 1: Model 170 used with the medically-approved mains...
  • Page 42 Diagram 2: Model 170 used with the medically- approved mains adapter and printer Mains Outlet Medical Mains Adapter Model 170 Audiometer Mains Outlet Printer via Printer PRINTER socket Power Supply D-0115687-C (OM008) – 170 Operating Manual...
  • Page 43 Diagram 3: Model 170 used with the medically- approved mains adapter and PC Mains Outlet Medical Mains Adapter Model 170 Audiometer Mains Outlet Power Supply via USB socket D-0115687-C (OM008) – 170 Operating Manual...
  • Page 44 Copyright © 2018 Amplivox Ltd. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Amplivox Ltd. D-0115687-C (OM008) – 170 Operating Manual...

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