AmpliVox PC850 Operating Manual
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AmpliVox PC850 Operating Manual

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PC850
Operating Manual

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  • Page 1 PC850 Operating Manual...
  • Page 2 ABOUT THIS MANUAL READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT. This manual is valid for the PC850 (applies from serial number 24164 and Audibase version 5.5 onwards). This product is manufactured by: Amplivox Ltd. Amplivox Ltd. 10393 West 70th Street...

  • Page 3: Table Of Contents

    Measuring Security ..........................11 3.3.8. Miscellaneous ............................11 3.3.9. Use of equipment after transport and storage ..................12 3.4..............................12 ONNECTIONS USING THE PC850 (COMPUTER CONTROLLED) ....................14 4.1................................14 ENERAL 4.2....................... 14 WITCHING THE UDIOMETER N AND 4.3.
  • Page 4 TANDARDS AND REGULATORY 9.2............................35 NPUT UTPUT 9.3..............................35 HYSICAL 9.4....................36 ARPHONE OUND TTENUATION HARACTERISTICS 9.5..............................36 ENVIRONMENTAL EMC GUIDANCE & MANUFACTURER’S DECLARATION ...................37 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT ..................42 D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 5: Introduction

    Its primary use is as an automatic audiometer (interfacing to and launched from the Amplivox Audibase PC software). However it may also be used as a “standalone” manual audiometer that can save the results of up to 12 tests. These tests may then be transferred to Audibase at a later stage.

  • Page 6: Warnings

    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 7: Principles Of Operation

    The schematic diagram below shows a typical example of the use of audiometric test equipment. The audiometer is located on the desk of a seated operator as shown. Computer (e.g. Tablet/Laptop) Operator Patient, wearing headset Headset lead PC850 Audiometer Response switch & lead D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 8 In the case of Manual or Computer testing – “As soon as you hear the tone, press and release the response switch” • In the case of Bekesy testing – “press and hold the response switch when a series of pulses are heard, and release when the pulses are no longer heard” D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 9: Unpacking And Installation

    Failing to do so may endanger the environment. The CE-mark indicates that Amplivox Ltd. meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system.

  • Page 10: Safety Instructions

    Amplivox Ltd. is aware that safety rules within individual organizations vary. If a conflict exists between the instructions in this manual and the rules of the organization using this instrument, the more stringent rules should take precedence.

  • Page 11: Environmental Factors

    Connect only accessories purchased from Amplivox Ltd. to the PC850. Only accessories which have been stated by Amplivox Ltd. to be compatible are allowed to be connected to the device or cradle. To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for electromagnetic compatibility (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 12: Electromagnetic Compatibility (Emc)

    3.3.7. MEASURING SECURITY To guarantee that the PC850 works properly, the instrument should be checked and calibrated at least once a year. The transducers supplied with the audiometer are specifically calibrated with it; if these transducers are changed recalibration will be required.

  • Page 13: Use Of Equipment After Transport And Storage

    USB Connector, Type B Reserved port; Amplivox diagnostic use 6 pin mini DIN only Power Mains AC/DC Adapter 2.5mm power jack Response Patient Respone Switch * 6.3mm jack Power Switch On / Off Switch D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 14 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 Amplivox PC850 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 15: Using The Pc850 (Computer Controlled)

    4. USING THE PC850 (COMPUTER CONTROLLED) 4.1. GENERAL Please note: Before the PC850 can be used as an automatic audiometer, the operating software and the Audibase application must be installed and registered on the connected PC. Refer to the relevant section of the Audibase operating manual for details of this operation.

  • Page 16: Available Test Modes

    Alternatively use the “Test > Launch Test” drop-down menu selection at the top of the Audibase window. A new window will open for the PC850 software. If the patient has more than one set of audiometric results stored in Audibase the most recent audiogram is transferred and displayed in the PC850 window.

  • Page 17: Computer Testing

    4.5.4. SINGLE FREQUENCY TEST The PC850 provides the facility to repeat a test at a specified single frequency and add the results into the overall audiogram result. This feature is useful for situations where one particular frequency has proved problematic.

  • Page 18: Running A Previous Test Type

    Assuming that an automatic test is in use, the serial number of the connected audiometer is shown at the bottom right of the PC850 window and the status message “Running test” is displayed at the bottom left. Additionally, the message “Linked” is shown on the display of the audiometer.

  • Page 19: Manual Testing

    “Current readings” box and enter the required memory location (numbers 1 to 12). Click on OK, and the selected data will be transferred to Audibase when the PC850 window is closed. Remember to “save” the data in Audibase to retain it in the database (refer to the Audibase operating manual).

  • Page 20: Computer Testing

    Click the Computer test button (the button will then be highlighted) Alternatively use the “Test > Computer” drop-down menu selection at the top of the PC850 window. A screen similar to that shown is displayed but with the “Present” icon and cursor removed.

  • Page 21: Békésky Test

    This option allows an automatic test at a single frequency to be repeated, for example if the full automatic test has been unable to record a threshold. Use the “Test > One freq. test” drop-down menu selection at the top of the PC850 window to select the single frequency from those available for testing.
  • Page 22 In this case leave “Current readings” selected, click on OK, and the combined data will be transferred to Audibase when the PC850 window is closed. Remember to “save” the data in Audibase to retain it in the database (refer to the Audibase operating manual).

  • Page 23: Using The Pc850 Stand-Alone

    YES key to save the audiogram; then release MENU Use the SIGNAL  keys to select the required storage Load audiogram no (1): location and press the YES key to load the audiogram; then release MENU D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 24: Description Of Function Of Other Keys

    The operator can then review the results at the end of the test and record them on an audiogram card, transfer them into the internal memory or transfer the results into the Amplivox Audibase application. Once a threshold has been determined press the “selected” ear key once again and the level will be stored and displayed in a similar way to that shown below.

  • Page 25: Saving Audiograms In Internal Memory

    Release the MENU key once confirmation appears on the display. 5.8. DATA TRANSFER TO AMPLIVOX AUDIBASE Refer to the Audibase operating manual to transfer test results to a PC with the Amplivox Audibase software installed. 5.9. SUGGESTED SEQUENCE OF OPERATION AND TEST PROCEDURE The following notes are for guidance only.

  • Page 26: Test

    (2) If required do one or more of the following: • Record the results on an audiogram card, or • Save the results to the internal memory, or • Transfer the results to a computer D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 27: Options Available To Set-Up

    6. OPTIONS AVAILABLE TO SET-UP 6.1. GENERAL The PC850 software stores the most recent test configuration and will initially use this to run any subsequent tests. However, there are a number of options available for setting up, modifying and controlling a test.

  • Page 28: Troubleshooting

    • That the PC850 audiometer is switched on • That the PC850 audiometer is connected to the computer • That the PC850 software has been installed correctly Click OK to close the box and then use the “Edit > Cancel Insert/Edit” option to cancel the operation. Audibase functions may then be continued.

  • Page 29: Continual Response From Patient

    If no results are available to transfer to Audibase the following dialogue box will be displayed: This could be because the PC850 window was closed before any thresholds could be recorded, the test was aborted or some other problem has occurred with the test sequence. Click OK to close the box and then use the “Edit >...

  • Page 30: Inconsistency In 1Khz Repeat Test

    It may be possible to select control buttons and menus options in the PC850 window on the PC but these will have no effect. Reconnecting the USB lead will also have no effect.

  • Page 31: Accidental Closure Of Pc850 Program

    7.9. ACCIDENTAL CLOSURE OF PC850 PROGRAM If the PC850 program is closed while an automatic test is running the test will end and the “No results” message will be displayed in Audibase. It will be necessary to switch the audiometer off and on. Clear any test results and re-start the test.

  • Page 32: Routine Maintenance

    70% isopropyl alcohol only on hard cover surfaces 8.2. AUDIOMETER MAINTENANCE The PC850 audiometer is a precision instrument. Handle it carefully in order to ensure its continued accuracy and service. When cleaning the instrument, use a soft damp cloth and mild detergent to clean the instrument panel.

  • Page 33: Headset Maintenance

    United Kingdom hello@amplivox.com This should also be done every time an instrument is returned to Amplivox Ltd. (This of course also applies in the unlikely worst case scenario of death or serious injury to a patient or user). When packing the instrument for shipping, please use the original shipping carton and packing materials. Place the instrument parts in plastic bags before packing.

  • Page 34: Warranty

    This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Amplivox Ltd. shall not be responsible for, any loss arising in connection with the purchase or use of any Amplivox Ltd. product that has been: •...
  • Page 35 The earphones may go out of calibration due to rough handling or impact (dropping). The life of the leads is also dependent upon conditions of use. These parts are only guaranteed against faulty materials or manufacture. D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 36: Technical Specifications

    Mode of operation: Continuous operation Equipment mobility: Portable The Model PC850 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. Audiometer type: Type 4 (IEC 60645-1:2001) Type 4 (ANSI S3.6:2004)

  • Page 37: Earphone Sound Attenuation Characteristics

    Operating temperature: C to +35 Storage/transport temperature: C to +70 Humidity (operating): 30% to 90% (non-condensing) Humidity storage/transport): 10% to 90% (non-condensing) Atmospheric Pressure (operating): 700hPa to 1060hPa Atmospheric Pressure 500hPa to 1060hPa (storage/transport): D-0116493-B (OM015) – PC850 Operating Manual...

  • Page 38: Emc Guidance & Manufacturer'sdeclaration

    NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction. No further steps required. D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic emissions The PC850 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of PC850 Audiometer should assure that it is used in such an environment. Emissions test Electromagnetic environment – guidance...
  • Page 40 ) for 5 (100% dip in U ) for 5 Power frequency (50/60Hz) 30 A/m 30 A/m Power frequency magnetic magnetic field fields should be at levels characteristic typical location typical commercial hospital IEC 61000-4-8 environment. D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 41 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The PC850 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the PC850 Audiometer should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 42 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 PC850 audiometer including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.

  • Page 43: Use With Non-Medical Electrical Equipment

    Refer to Diagrams 1 & 2 below for typical configurations of connected peripheral equipment. Refer to Amplivox Ltd at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment.
  • Page 44 Diagram 1: PC850 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter PC850 Audiometer D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 45 D-0116493-B (OM015) – PC850 Operating Manual...
  • Page 46 Copyright © 2019 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-0116493-B (OM015) – PC850 Operating Manual...

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