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Summary of Contents for AmpliVox 170
- Page 1 INSTRUCTION FOR USE D-0115687-J...
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Page 2: About This Manual
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:... -
Page 3: Table Of Contents
SUGGESTED SEQUENCE OF OPERATION AND TEST PROCEDURE 4.1. UDIOMETRY PREPARATION AND AMBIENT CONDITIONS 4.2. EST SYSTEM ARRANGEMENT 4.3. EADSET 4.4. ATIENT INSTRUCTIONS 4.4.1. Pre-test 4.4.2. Familiarisation 4.4.3. Test 4.4.4. Post-test Error messages 4.4.5. SPECIFICATION 2 MODEL 170 INSTRUCTION FOR USE... - Page 4 INSTRUMENT STORAGE AND TRANSPORTATION 10. CALIBRATION AND REPAIR OF THE INSTRUMENT 11. GUARANTEE 12. ORDERING CONSUMABLES AND ACCESSORIES 13. DISPOSAL INFORMATION APPENDIX 1 - EMC GUIDANCE & MANUFACTURER’S DECLARATION APPENDIX 2 - USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT 3 MODEL 170 INSTRUCTION FOR USE...
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Page 5: Introduction
Test results may be printed using the specified printer option or transferred to a PC running the Amplivox Audibase or AudiView applications. -
Page 6: Optional Accessories
1.6. OPTIONAL ACCESSORIES Additional audiogram cards Audibase software USB Cable Printer(s) Printer cable(s) Audiocups (noise reducing earphone enclosures) 1.7. OPTIONAL ACCESSORIES Additional audiogram cards Audibase software USB Cable Printer(s) Printer cable(s) Audiocups (noise reducing earphone enclosures) 5 MODEL 170 INSTRUCTION FOR USE... -
Page 7: Important Safety Instructions
IMPORTANT SAFETY INSTRUCTIONS 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 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 170 Screening 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
The audiometer is supplied with software to allow connection to a computer for the transfer of test results (see Section 3.7). You must use the designated USB cable which is available from Amplivox (see Section 12). 8 MODEL 170 INSTRUCTION FOR USE... -
Page 10: Using The Audiometer
NO, YES or SIGNAL keys to select an action or modify a setting. Release of the MENU key then initiates the action or saves the modified setting and returns to the default display. 9 MODEL 170 INSTRUCTION FOR USE... -
Page 11: Description Of Function Of Other Keys
Use this key at the conclusion of an automatic test to view the results (see Section 4.5.4) TALK OVER 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; if an 10 MODEL 170 INSTRUCTION FOR USE... -
Page 12: Threshold Retention Function
SIGNAL dBHL FREQUENCY Hz 30dB 4kHz This display shows thresholds at 4kHz THRESHOLDS Left ear 20dBHL Right ear 10dBHL 11 MODEL 170 INSTRUCTION FOR USE... -
Page 13: Saving Audiograms In Internal Memory
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 14: 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” 13 MODEL 170 INSTRUCTION FOR USE... -
Page 15: Pre-Test
Print the results (Section 3.6), or ▪ Transfer the results to a computer (Section 3.7) Refer to Section 3.4.2 to clear the thresholds at the end of a test and, if required, switch off the audiometer. 14 MODEL 170 INSTRUCTION FOR USE... -
Page 16: Error Messages
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. 15 MODEL 170 INSTRUCTION FOR USE... -
Page 17: Specification
2 lines of 24 characters Mains Power: 100-240Vac; 50-60Hz; 0.5A Input Rating: 5Vdc; 1.2 A Dimensions: 270mm long x 165mm deep x 60mm high Weight: 0.75kg (approx) Safety: IEC 60601-1 (plus UL, CSA & EN deviations) 16 MODEL 170 INSTRUCTION FOR USE... -
Page 18: Equipment Classification
Continuous operation Equipment mobility Portable The Model 170 Audiometer is classified as a Class IIa device under Annex II of the EU Medical Devices Regulation. It is intended for use as a screening audiometer instrument. 17 MODEL 170 INSTRUCTION FOR USE... -
Page 19: Symbols
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. 18 MODEL 170 INSTRUCTION FOR USE... -
Page 20: 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 19 MODEL 170 INSTRUCTION FOR USE... -
Page 21: 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 22: Instrument Storage And Transportation
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 23: Ordering Consumables And Accessories
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.ltd.uk). The required fitting instructions are supplied with each part. -
Page 24: Disposal Information
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/GA0170XU and we are registered with the approved WEEE Compliance Scheme, B2B Compliance, approval number WEE/MP3338PT/SCH. -
Page 25: Appendix 1 - Emc Guidance & Manufacturer'sdeclaration
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 26 IEC 61000-4-8 NOTE U is the a.c. mains voltage prior to the application of the test level 25 MODEL 170 INSTRUCTION FOR USE...
- Page 27 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 28 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 170 audiometer including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.
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Page 29: 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 connected... - Page 30 APPENDIX 2 - USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 3: Model 170 used with the medically-approved mains adapter and PC Medical Mains Adapter Model 170 Mains outlet Via USB Mains outlet PC Adapter PC 29 MODEL 170 INSTRUCTION FOR USE...
- Page 31 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-0115687-J...
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