AmpliVox 260 Instructions For Use Manual
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AmpliVox 260 Instructions For Use Manual

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INSTRUCTION FOR USE
D-0115700-J

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  • Page 1 INSTRUCTION FOR USE D-0115700-J...

  • 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 260 (applies from firmware version 2T06 onwards – please refer to section 1.3). This product is manufactured by: Amplivox Ltd...

  • Page 3: Table Of Contents

    4.1. UDIOMETRY PREPARATION AND AMBIENT CONDITIONS 4.2. EST SYSTEM ARRANGEMENT 4.3. EADSET 4.4. ATIENT INSTRUCTIONS 4.5. TEST 4.6. 4.7. TEST SPECIFICATION 5.1. UTPUT DATA 5.2. AXIMUM HEARING LEVELS PROVIDED AT EACH FREQUENCY 5.3. HYSICAL 2 MODEL 260 INSTRUCTION FOR USE...
  • Page 4 MPLIFIER AND OUDSPEAKER A2.3 ALIBRATION VERVIEW A2.4 FIELD PEECH ALIBRATION A2.5 FIELD ARBLE ONES ALIBRATION A2.6 FIELD PEECH ALIBRATION APPENDIX 3 - EMC GUIDANCE & MANUFACTURER’S DECLARATION APPENDIX 4 - USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT 3 MODEL 260 INSTRUCTION FOR USE...

  • Page 5: Introduction

    INTRODUCTION 1. INTRODUCTION 1.1. THANK YOU 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. 1.2. INTENDED APPLICATIONS The Model 260 diagnostic audiometer is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals.

  • Page 6: Optional Accessories

    INTRODUCTION 1.6. OPTIONAL ACCESSORIES Masking earpiece Additional audiogram cards Microphone and monitor headset Insert earphones Printer(s) Printer cable(s) USB Cable Audiocups (noise reducing earphone enclosures) 5 MODEL 260 INSTRUCTION FOR USE...

  • Page 7: Important Safety Instructions

    IMPORTANT SAFETY INSTRUCTIONS 2. IMPORTANT SAFETY INSTRUCTIONS The 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. 2.1. PRECAUTIONS READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for EMC the audiometer is designed to be used only with the medically-approved mains adapter supplied, which is specified as part of the equipment.

  • Page 8: Audiometer Connections

    For connected parts marked * only connect the accessories supplied with the instrument or supplied by Amplivox or an Amplivox distributor. These parts have been tested for use with the 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 Printer

    Please refer to Appendix 4 for important information regarding the connection of non-medical electrical equipment to medical electrical equipment. The Model 260 has audio line in/out connections for CD or tape player input (e.g. for recorded speech testing) and amplifier output.

  • Page 10: Using The Audiometer

    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. 9 MODEL 260 INSTRUCTION FOR USE...

  • Page 11: Menu

    Select printer: the Sanibel MPT-II printer Please note: In order to use the Sanibel printer, select ABLE printer in the settings. After confirming the ABLE printer, the 260 will connect to the Sanibel printer, too. 10 MODEL 260 INSTRUCTION FOR USE...

  • Page 12: Description Of Function Of Other Keys

    2.5dB or 5dB steps (see Section 3.4.2); to scroll through the range keep the key pressed These keys are also used to set the LINE & MIC levels in SPEECH mode 11 MODEL 260 INSTRUCTION FOR USE...

  • Page 13: Test Menu

    30dBHL 4kHz thresholds at 4kHz [ 20L] [ 10R] 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. 12 MODEL 260 INSTRUCTION FOR USE...

  • Page 14: Saving Audiograms In Internal Memory

    Three designated thermal printers (the Able AP1300, the Martel MCP8830 or Sanibel MPT-II) are available as options for use with the Model 260 audiometer. The correct printer must be selected (use the MENU options described in Section 3.4.2 to make this selection).

  • Page 15: Data Transfer To Noah Or Amplisuite

    3.9. DATA TRANSFER TO NOAH OR AMPLISUITE To transfer test results stored within the audiometer to a NOAH database the Amplivox ampliSuite NOAH software must be installed on to a computer. Alternatively, Amplivox ampliSuite allows data to be transferred to a computer and subsequently viewed, annotated &...

  • Page 16: Suggested Sequence Of Operation And Test Procedure

    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” 15 MODEL 260 INSTRUCTION FOR USE...

  • Page 17: Pre-Test

    Save the results to the internal memory (Section 3.6), or • Print the results (Section 3.8), or • Transfer the results to a computer (Section 3.9) To clear the Threshold Retention memory, use the Clear test menu option described in Section 3.4.2. 16 MODEL 260 INSTRUCTION FOR USE...

  • Page 18: 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) USB interface: Transfer of test results to a computer 17 MODEL 260 INSTRUCTION FOR USE...

  • Page 19: Maximum Hearing Levels Provided At Each Frequency

    Type of protection against electric shock Powered via SELV ClassII mains adapter Degree of protection against electric shock Type B applied part Degree of protection against ingress of water Not protected Mode of operation Continuous operation Equipment mobility Portable 18 MODEL 260 INSTRUCTION FOR USE...
  • Page 20 SPECIFICATION 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. 19 MODEL 260 INSTRUCTION FOR USE...
  • Page 21 Definition: Class II equipment – equipment in which protection against electric shock does not rely on 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. Definition: Medical device. 20 MODEL 260 INSTRUCTION FOR USE...
  • Page 22 Meets IEC 60645-2; ANSI S3.6 Reference levels: Refer to ISO 389-4 Insert Masking Earpiece Calibration method: With 2cc coupler compliant with IEC 126 Transducers Types and reference levels: DD45: ISO 389-1, Table 3 E-5A: ISO 389-2, Table 1 21 MODEL 260 INSTRUCTION FOR USE...
  • Page 23 6.3mm Jack socket Left / Right / Bone outputs: 6.3mm Jack socket Monitor output: Mono 3.5mm Jack socket Insert output: Mono 3.5mm Jack socket USB: Type B socket Maximum voltage at any output: 12V peak 22 MODEL 260 INSTRUCTION FOR USE...
  • Page 24 8.1. AUDIOMETER MAINTENANCE The 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 25 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. See Section 2.3.
  • Page 26 All Amplivox instruments are guaranteed against faulty materials and manufacture. The instrument will be repaired free of charge for a period of three 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 27 Shipping documentation will reference the stock number quoted above, and images of the parts alongside the relevant stock number are available on the Amplivox website (www.amplivox.com). The required fitting instructions are supplied with each part.
  • Page 28 DISPOSAL INFORMATION 13. DISPOSAL INFORMATION Amplivox Limited is fully compliant with the WEEE (Waste Electrical and Electronic Equipment) Regulations. Our PRN (Producer Registration Number) is WEE/GA0116XU and we are registered with the approved WEEE Compliance Scheme, B2B Compliance, approval number WEE/MP3338PT/SCH.
  • Page 29 APPENDIX 1 - SPEECH AUDIOMETRY The 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 Sound from LINE IN is continually routed to the patient - to interrupt this, press and hold the PRESENT key; if a constant presentation to the patient is not desired, press the CONSTANT key (the LED will extinguish) and use the PRESENT key while presenting the test material 29 MODEL 260 INSTRUCTION FOR USE...
  • Page 31 The external microphone is now routed to the external amplifier and speaker; use LEFT and RIGHT to select the required amplifier channel Continue from Section A1.1.1d) to Section A1.1.1g) above A1.5.2 Procedure: As described in A1.1.2. 30 MODEL 260 INSTRUCTION FOR USE...
  • Page 32 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. 31 MODEL 260 INSTRUCTION FOR USE...
  • Page 33 APPENDIX 2 - FREE FIELD CALIBRATION PROCEDURE A2.1 ASSURANCE OF CALIBRATION The following is a brief description of the equipment and procedures to be used with the 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 34 For each alternative set of test recordings produce a correction table (the difference between the actual listening point level measured and 90dBSPL) • Apply this correction to the output level of the audiometer while conducting a test to compensate for the minor difference in calibration level 33 MODEL 260 INSTRUCTION FOR USE...
  • Page 35 To store the levels and leave Free-field calibration mode, press the MENU key • If required, all calibration levels can be set to a default of zero by pressing the +20dB key while in free-field calibration mode 34 MODEL 260 INSTRUCTION FOR USE...
  • Page 36 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 35 MODEL 260 INSTRUCTION FOR USE...
  • Page 37 DECLARATION Guidance and manufacturer’s declaration – electromagnetic emissions The 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.
  • Page 38 IEC 61000-4-8 NOTE U is the a.c. mains voltage prior to the application of the test level 37 MODEL 260 INSTRUCTION FOR USE...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The 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 40 NOTE 3 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Model 260 audiometer including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.
  • Page 41 16 of IEC 60601-1:2005 are met. The following signal inputs and outputs on the 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-powered equipment connected...
  • Page 42 Diagram 3: Model 260 used with the medically-approved mains adapter and PC Medical Mains Adapter Mains outlet Model 260 Via USB Adapter PC Mains outlet Diagram 4: Model 260 used with the medically-approved mains adapter and CD/Tape player Medical Mains Adapter Model 260 Mains outlet Via cable Adapter CD/tape Mains outlet...
  • Page 43 Copyright © 2021 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-0115700-J...

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