Аудиометр ампливокс 270 руководство по эксплуатации

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  Model 270 Operating 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 270 (applies from firmware version 2T06 onwards – please refer to section 1.3). This product is manufactured by: Amplivox Ltd.

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  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 1.1 Intended applications …………..1 1.2 Unpacking ………………1 1.3 Firmware version …………….1 1.4 Standard contents ……………. 1 1.5 Optional accessories…………..2 2 Important Safety Instructions …………..2 2.1 Precautions ………………. 2 2.2 Electromagnetic compatibility (EMC) considerations ….3 2.3 Mains supply operation …………..

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  Appendix 1 — Speech Audiometry …………..25 Appendix 2 — Free Field Calibration Procedure ……….. 30 Appendix 3 — EMC Guidance & Manufacturer’s Declaration …… 36 Appendix 4 — Use with Non-medical Electrical Equipment ……42…

• Page 7: Introduction

  1 Introduction Thank you for purchasing an Amplivox audiometer. The Amplivox Model 270 is a diagnostic audiometer that will give many years of reliable service if treated with care. 1.1 Intended applications The Model 270 diagnostic audiometer is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals.

• Page 8: Optional Accessories

  Printer cable(s) USB Cable Audiocups (noise reducing earphone enclosures) 2 Important Safety Instructions The Model 270 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…

• 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

  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 270 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 11: Data Transfer To A Printer

  The Model 270 has audio line in/out connections for CD or tape player input (e.g. for recorded speech testing) and amplifier output. Line out connections are switched on only when FREEFIELD is selected.

• Page 12: Using The Audiometer

  English (Softkey 1) or Deutsch (Softkey 3). 3.3 Testing the patient response switch Press the patient response switch and the light labelled RESPONSE (to the left of the display) will illuminate green. Page 6 OM020-9 Model 270 Operating Manual…

• Page 13: Audiometer Display

  LOAD key Contrast: Adjust using the UP and DOWN keys Bone masking: Selects the headset or the optional insert masking earpiece as the means of masking; select ‘Insert’ or ‘Phones’ key Model 270 Operating Manual OM020-9 Page 7…

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  The units displayed for freefield speech may be switched between dBHL and dBSPL 3.5.3 Description of Function of Other Keys SIGNAL HL The rotary control is used to increase or decrease the signal level in the selected step size. Page 8 OM020-9 Model 270 Operating Manual…
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  100dBHL. Note: this function will not operate if continuous tone presentation has been enabled. Model 270 Operating Manual OM020-9 Page 9…
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  Enables the operator to set either 2.5dB or 5dB as the default step size. PHONES This option is only available if a secondary headphone has been enabled; this will enable the operator to select the required output transducers. Page 10 OM020-9 Model 270 Operating Manual…

• Page 17: Threshold Retention Function

  (air conduction, bone conduction and ULL). Once a threshold has been determined press the STORE key. Alternatively use the “Store on 2 of 3” function (see Section 3.5.2). The threshold will be recorded and displayed as shown below. Model 270 Operating Manual OM020-9 Page 11…

• Page 18: Saving Audiograms In Internal Memory

  (see Appendix 1) will also be saved. Note that the Save process will overwrite any records that exist in the memory location. Press the QUIT key once confirmation that the thresholds have been saved appears on the screen. Page 12 OM020-9 Model 270 Operating Manual…

• Page 19: Loading Audiograms From Internal Memory

  Three designated thermal printers (the Able AP1300 or the Martel MCP8830 or the Sanibel MP-II) are available as options for use with the Model 270 audiometer. The correct printer must be selected (use the MENU options described in Section 3.5.2 to make this selection).

• Page 20: Suggested Sequence Of Operation And Test Procedure

  The headset or appropriate transducer must be fitted by a qualified person to ensure a proper seal and a comfortable fit. The leads from the headset are connected to the instrument and the headset is then fitted to the patient. Page 14 OM020-9 Model 270 Operating Manual…

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  (15) Use the Threshold Retention Function to review the results (See 3.6) (16) If required do one or more of the following:  Record the results on an audiogram card, or  Save the results to the internal memory (Section 3.7), or Model 270 Operating Manual OM020-9 Page 15…

• Page 22: Specification

  Integral talkover and talkback 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 Page 16 OM020-9 Model 270 Operating Manual…

• Page 23: Maximum Hearing Levels Provided At Each Frequency

  Mode of operation Continuous operation Equipment mobility Portable The Model 270 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. Model 270 Operating Manual…

• Page 24: Symbols

  125Hz to 8kHz as per pure tones Modulation waveform: Sinusoidal Rising and falling symmetry: Symmetrical on linear frequency scale Modulating frequency: 15.625Hz Frequency deviation: +/-10% Speech Channel Frequency response: +/- 3dB from 100Hz to 10kHz electrical Page 18 OM020-9 Model 270 Operating Manual…

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  Mic input connection: Mono 3.5mm Jack socket Line input impedance: 6800 Ohms Line in/out connections: Stereo 3.5mm Jack Sockets Patient response input: 6.3mm Jack socket Left / Right / Bone outputs: 6.3mm Jack socket Model 270 Operating Manual OM020-9 Page 19…

• Page 26: Routine Maintenance

  8 Routine Maintenance 8.1 Audiometer maintenance The Model 270 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 27: 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 DO NOT USE ANY OTHER TYPE OF MAINS ADAPTER WITH THIS INSTRUMENT.

• Page 28: Instrument Storage And Transportation

  500 hPa to 1060 hPa 10 Calibration and Repair of the Instrument Amplivox recommend 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 29: 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 30: 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 31: Appendix 1 — Speech Audiometry

  Appendix 1 — Speech Audiometry The Model 270 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.

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  The MASK rotary control changes the masking level in 5dB steps d) If required, readjustment of the input signal level can be accessed by temporarily deselecting the MASK key — then proceed as in A1.1.1d) Page 26 OM020-9 Model 270 Operating Manual…
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  The MASK rotary control changes the masking level in 5dB steps e) If required, readjustment of the input signal level can be accessed by temporarily deselecting the MASK key — then proceed as in A1.3.1d) Model 270 Operating Manual OM020-9 Page 27…
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  Appendix 2 e) The input signal is adjusted in 1dB steps by use of the MASK control Adjust the input signal such that the LEVEL dB bar graph reads 0dB Page 28 OM020-9 Model 270 Operating Manual…
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  LINE OUT channel b) Use the SIGNAL control to adjust the signal channel and MASK control to adjust the noise channel A1.8.2 Procedure: As described in A1.3.2 but adjusting the competing noise level as required. Model 270 Operating Manual OM020-9 Page 29…

• Page 36: Appendix 2 — Free Field Calibration Procedure

  Assurance of Calibration The following is a brief description of the equipment and procedures to be used with the Model 270 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 &…

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  The response should then be checked to be within the following limits (IEC 60645-2:1993 Section 10.1): Frequency Range (Hz) Tolerance (dB) 125 to 250 +0/-10 250 to 4000 +3/-3 4000 to 6300 +5/-5 Model 270 Operating Manual OM020-9 Page 31…
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  Page 32 OM020-9 Model 270 Operating Manual…
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  To calibrate the Right channel (if required) press the RIGHT key (do not change the amplifier’s volume control)  Adjust the calibration for all of the right channel frequencies (including   1000Hz) by using the keys and the SIGNAL control as described above Model 270 Operating Manual OM020-9 Page 33…
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  If necessary it is possible to switch between speech (competing noise) and warble calibration modes by pressing SPEECH and WARBLE respectively  To store the levels and leave Free-field calibration mode, press the STORE key Page 34 OM020-9 Model 270 Operating Manual…
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  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 Model 270 Operating Manual OM020-9 Page 35…

• Page 42: Appendix 3 — Emc Guidance & Manufacturer’s Declaration

  Guidance and manufacturer’s declaration – electromagnetic emissions The Model 270 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 270 Audiometer should assure that it is used in such an environment.

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  Guidance and manufacturer’s declaration – electromagnetic immunity (1) The Model 270 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 270 Audiometer should assure that it is used in such an environment.
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  IEC 61000-4-8 typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to the application of the test level Page 38 OM020-9 Model 270 Operating Manual…
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  Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Model 270 Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Model 270 Audiometer should assure that it is used in such an environment.
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  If the measured field strength in the location in which the Model 270 Audiometer is used exceeds the applicable RF compliance level above, the Model 270 Audiometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 270 Audiometer.
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  Recommended separation distances between portable and mobile RF communications equipment and the Model 270 Audiometer The Model 270 Audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the…

• Page 48: Appendix 4 — Use With Non-Medical Electrical Equipment

  16 of IEC 60601-1:2005 are met. The following signal inputs and outputs on the Model 270 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…

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  Diagram 1: Model 270 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter Model 270 Audiometer Model 270 Operating Manual OM020-9 Page 43…
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  Diagram 2: Model 270 used with the medically-approved mains adapter and printer Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet Printer Printer via DATA socket Power Supply Page 44 OM020-9 Model 270 Operating Manual…
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  Diagram 3: Model 270 used with the medically-approved mains adapter and PC Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet Power Supply via USB socket Model 270 Operating Manual OM020-9 Page 45…
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  Diagram 4: Model 270 used with the medically-approved mains adapter and CD/Tape player Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet CD/Tape Player via LINE IN Socket Page 46 OM020-9 Model 270 Operating Manual…
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  Diagram 5: Model 270 used with the medically-approved mains adapter and external amplifier Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet Amplifier via LINE OUT Socket Model 270 Operating Manual OM020-9 Page 47…

2-канальный диагностический аудиометр

Диагностический аудиометр 270 представляет собой идеальный 2-канальный аудиометр, который используют врачи-специалисты в области слуха по всему миру. Аудиометр отличается эргономичным дизайном и четким распределением функций, при этом ключевые функции аудиометра назначены особым клавишам.

Многие отмечают необыкновенную легкость обучения работе с этим прибором и простоту его использования.

Функции, которые вам понравятся

• 2-канальная аудиометрия
• Диапазон частот: 125–8000 Гц
• Диапазон затухания: -10–100 дБ нПс
• Воздушная (AC) и костная (BC) проводимость
• Речевое исследование (вживую и с записанной речью)
• Выбор тона: одиночный, пульсирующий, трель, постоянный
• Узкополосная маскировка
• Специальные проверки: ABLB, Stenger, SISI
• Портативная и легкая конструкция
• Дополнительная функция питания от батарей
• Встроенная функция разговора с пациентом «Talk Forward»
• Функция сохранения порога (во время проверки)
• Внутренняя память
• Включена функция обработки данных после тестирования

Содержание комплекта

• Стандартная аудиометрическая гарнитура
• Гарнитура для измерения костной проводимости
• Кнопка реакции пациента
• Футляр для переноски
• Блок питания с адаптерами под национальный разъем сетевого питания
• Карты для аудиограммы (x50)
• USB-накопитель (с руководствами и программным обеспечением)
• ПО ampliSuite для компьютера
• Аудиометрический модуль для NOAH

Обновления и принадлежности

• Улучшение наушников с помощью шумопоглощающих амбушюр (Audiocups)
• Комбинированный телефон с микрофоном
  (гарнитура)
• Микрофон пациента
• Внутриушной телефон для маскирования
• Термопринтер
• USB-кабель (для подключения к ПК)

Настройка слуховых аппаратов

Диагностический аудиометр модели 270 — это прекрасный выбор для любого распространителя слуховых аппаратов. Инструмент может записывать и сохранять порог слышимости для воздушной и костной проводимости, а также порог дискомфорта — параметры, необходимые для правильной настройки слухового аппарата. Модель 270 позволяет выполнять речевую диагностику и диагностику в свободном поле с помощью двух подключенных динамиков (опция). 

Управление данными — на ваше усмотрение

Вы сами решаете, как будет осуществляться управление вашими данными. Прибор сохранит записи, которые вы сможете распечатать на термопринтере или перенести на компьютер.

Все инструменты включают в себя наше бесплатное программное обеспечение ampliSuite С его помощью можно легко переносить результаты, анализировать, добавлять, классифицировать по категориям, печатать и сохранять данные пациентов.

В приборах Amplivox также используется соединительный модуль NOAH, который уже интегрировали в свои системы многие поставщики электронных медицинских карт (EMR) для простоты управления данными.

Диагностический аудиометр Amplivox 270 представляет собой современный медицинский прибор для эффективного проведения дифференциальной оценки слуха пациента.

Преимущества аудиометра Amplivox 270

• Данное устройство отличается эргономичностью, надежностью и простотой в практическом применении.
• Широкое использование в устройстве перспективных цифровых технологий существенно расширило технический потенциал аудиометра. С помощью модели Amplivox 270 можно с высокой эффективностью выполнять разнообразные клинические испытания, записывать результаты тестов, выбирать оптимальные выходные преобразователи.
• Все элементы системы управления размещены так, чтобы пользователю было удобно работать с прибором.
• Показания обследования мгновенно отображаются на большом регулируемом (по углу наклона) дисплее.
• Устройство оснащено аттенюаторами бесщелчкового типа.
• В модели Amplivox 270 имеется функция сохранения слуховых порогов, которая сокращает период тестирования и повышает внимание обследуемого.
• Результаты тестирования хранятся во встроенной памяти.
• Есть возможность качественной распечатки полученных данных и передачи их на персональный компьютер.
• Аудиометр компактен, поэтому эксплуатировать его можно и в стационарах, и во время выездных обследований.

В комплект поставки аудиометра Amplivox 270 входят: аудиометр Amplivox 270; головные телефоны; костный телефон; кнопка ответа пациента; бланки аудиограмм (50 штук); руководство по эксплуатации; сетевой адаптер; интерфейс для NOAH; кейс для переноски.

Дополнительно можно приобрести: термопринтер и кабель для подключения к компьютеру с программой.

Технические характеристики аудиометра Amplivox 270