natus Aurical Aud User Manual
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natus Aurical Aud User Manual

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Aurical® Aud
User Guide
Doc. No. 7-50-1270-EN/13
Part No. 7-50-12700-EN

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  • Page 1 Aurical® Aud User Guide Doc. No. 7-50-1270-EN/13 Part No. 7-50-12700-EN...
  • Page 2 Copyright notice © 2012, 2021 Natus Medical Denmark ApS. All rights reserved. ® Natus, the Natus Icon, Aurical, Madsen, HI-PRO 2, Otoscan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries. Version release date 2021-04-12 (220758) Technical service and support Please contact your supplier.

  • Page 3: Table Of Contents

    Table of Contents Device description Intended use Unpacking Installation Connecting accessories to Aurical Aud Powering the device Connecting Aurical Aud to Otosuite On-screen controls PC keyboard controls 10 Toolbar icons in the Audiometry Module 11 Proper transducer placement 12 The Masking Assistant...

  • Page 4: Device Description

    Aurical Aud Hi-Pro 2 with speaker unit with speaker unit Aurical Aud is a PC-controlled audiometer for testing a person's hearing.The audiometer is operated from the Otosuite Audiometry Module PC software. • With Aurical Aud you can perform all standard audiometric tests, tone and speech audiometry and special tests.

  • Page 5: Unpacking

    3 Unpacking Use: The Aurical speaker unit is intended to present audio signals. The Aurical speaker unit is for use with Aurical Aud and the Audiometry module, with Aurical® FreeFit and the Otosuite PMM module and the Otosuite Counseling and Sim- ulations module.

  • Page 6: Installation

    Aurical Aud is fully assembled on delivery, and you simply have to connect the cables. Warning To connect Aurical Aud to the PC, use the supplied USB cable. The cable length must not • exceed 3 m (approx. 10 feet).

  • Page 7: Connecting Accessories To Aurical Aud

    Avoid connecting or disconnecting the hearing instrument while the connector light indicator is lit. Warning When you connect other electrical equipment to Aurical Aud, remember that equipment that does not • comply with the same safety standards as Aurical Aud can lead to a general reduction in the system's safety level. Aurical Aud...

  • Page 8: Powering The Device

    Speaker input for connecting to Aurical Aud Connecting external speakers External speakers can be connected to Aurical Aud via powered output terminals or line-out terminals. In both cases you should contact your service department for installation and calibration. See also Calibration ►...

  • Page 9: Connecting Aurical Aud To Otosuite

    When you use Aurical Aud for the first time, run the Configuration Wizard to set up the connection between Aurical Aud and Otosuite. After you have configured Otosuite for the first time, if Aurical Aud is turned on when you open the Control Panel in Otosuite, then Aurical Aud will connect to Otosuite automatically.

  • Page 10: On-Screen Controls

    Note The actual position of the keys may depend on your keyboard • type. Toolbar icons in the Audiometry Module The icons available in the toolbar depend on the test function that you have selected. Aurical Aud...
  • Page 11 Masking Assistant (Masking Assistant) The Masking Assistant causes an unmasked threshold to flash repeatedly if masking is recommended. The graph shows up to 20000 Hz. Aurical Aud presents stimulus up to Standard / All / High 12500 Hz. frequencies (Standard / All / High fre- •...

  • Page 12: Proper Transducer Placement

    Insert earphones have greater attenuation between ears especially at the low frequencies; this reduces the need for masking. 2. It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the foam eartip into the child's ears. Aurical Aud...

  • Page 13: The Masking Assistant

    The environment in which sound-field audiometry is performed may affect the sound field near the patient. The performance of loudspeakers for Aurical Aud was tested by Natus under free-field conditions in a large anechoic cham- ber. Sound pressure level, frequency response and distortion were measured by a microphone placed 1 m from the front of the speaker.
  • Page 14 (Configure... > Masking Assistant)). Min IA is frequency specific These are the Min IA tables for TDH-39 and Natus Inserts used in the Masking Assistant 1 Based on criteria described in Clinical Masking, Essentials of Audiology, Stanley A. Gelfand, Thieme 1997...
  • Page 15 Munro & Agnew, BJA (1999) 1500 N/A - traditional value 2000 Munro & Agnew, BJA (1999) 3000 Munro & Agnew, BJA (1999) 4000 Munro & Agnew, BJA (1999) 6000 Munro & Agnew, BJA (1999) 8000 Munro & Agnew, BJA (1999) Aurical Aud...

  • Page 16: Performing Tone Audiometry

    Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the on- screen controls located at the top of the screen or in the Control Panel to the left. For detailed examples of audiometric testing, see the Aurical Aud Reference Manual. Tone 1.

  • Page 17: Performing Speech Audiometry

    Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the on- screen controls located at the top of the screen or in the Control Panel to the left. For detailed examples of audiometric testing, see the Aurical Aud Reference Manual. Speech 1.
  • Page 18 The headset microphone should be turned to a position just below the operator’s mouth. If an external playback device is used to generate speech stimuli via the line input of Aurical Aud, only a high quality CD player or similar device should be used; tape recordings may not provide a sufficient signal to noise ratio.

  • Page 19: Maintenance

    12. Repeat until all the measurements you need have been completed. Dosimeter A dosimeter is built into Aurical Aud. If you are using live speech, it will be working in the background as a safety pre- caution. The system monitors the sound level versus duration of exposure (1) .
  • Page 20 3. Insert the USB memory stick in an empty slot on your PC. 4. Call your Natus technical support team. They will use the application TeamViewer to ensure correct remote install- ation of the new calibration data on your system.

  • Page 21: Other References

    Other references For more information, see the online Help in Otosuite, which contains detailed reference information about Aurical Aud and the Otosuite modules. For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium.
  • Page 22 Otosuite for levels above 100 dB HL. Table 1 - Offset from Effective Masking Level to Sound Pressure Level Frequency (Hz) 1000 1500 2000 3000 4000 6000 8000 9000 10000 11200 12500 Offset (dB) N/A* Aurical Aud...
  • Page 23 The reference conditions for the specification of frequency response and sound pressure level depend on the type of audi- ometer. Aurical Aud can be calibrated as either a “corrected” (Type AE) or “uncorrected” (Type A) speech audiometer: Type AE calibration: •...
  • Page 24 1 or 5 dB step resolution over the entire range. HL Range The maximum output levels from Aurical Aud depend on the actual sensitivity of the individual transducers, and they will be slightly different for each unit. However, the minimum requirements from IEC 60645-1:2007 and ANSI 63.6:2004 are fulfilled for all units.
  • Page 25 Passive sound field speaker using the built-in amplifier, or • External amplifier using the line output. Transducer options depend on how Aurical Aud is ordered and calibrated. 1. All headbands supplied with transducers comply with the ISO 389 series for that model of transducer unless oth- erwise specified.
  • Page 26 17 Technical specifications For audiometric testing outside of noise attenuating test rooms, Natus recommends using earphones which feature passive noise reduction. For the applicable earphone models, the attenuation is specified in the following table. Sound attenuation values for earphones Frequency...
  • Page 27 Additionally, Aurical Aud includes a feature which allows the operator to select the maximum output level from a bone conductor. Using this feature, the maximum output may be set lower than the physically available output level (installation option).
  • Page 28 USB 1.1 (compatible with USB 2.0, USB 3.0, USB 3.1, and USB 3.2 per www.USB.org) Transport and storage Temperature: -30°C to +60°C (-22°F to 140°F) Air humidity: 10% to 90%, non-condensing Air pressure: 50 kPa to 106 kPa Aurical Aud...
  • Page 29 Should be extended if Aurical Aud has been stored in a cold environment. • Disposal Aurical Aud and relevant accessories can be disposed of as normal electronic waste, according to WEEE and local reg- ulation. Refer to the disposal instructions described in this manual. Dimensions Aurical Aud: Approx.
  • Page 30 7-08-027 MAINS CORD, H05VV, CH PLUG 7-08-017 POWER CABLE, SJ, US HOSP. PLUG Essential performance Aurical Aud has no essential performance. Standards Audiometer: IEC 60645-1:2017, Type 2; ANSI S3.6:2004 Patient Safety: IEC 60601-1:2005/A1: 2012 (Edition 3.1), Class 1, Type B and IEC 60601-1 (2nd Edition) UL 60601-1;...
  • Page 31 Insert Earphone - Eartip 80A4821000 Eartip, Earlink 3B, small(bag of 50 pcs) Insert Earphone - Eartip 80A4821100 Eartip, Earlink 3C, jumbo(bag of 24 pcs) Insert Earphone 8-75-81200 INSERT PHONE,10OHM,JACK,STEREO Tube (insert Earphones) 8-68-32000 EAR tone, Tube Niples Speaker 8-62-45200 LOUDSPEAKER Aurical Aud...
  • Page 32 USB cable, type A-B, 1 meter 8-71-86500 Cables USB Cable, 3m with 2 Ferrite 8-62-45900 Cables Cable Plug (Jack/Phono) 8-70-900 Cables 1081, DC CABLE SHORT 8-71-89400 Cables 1081, DC CABLE LONG 8-71-89401 Cables 1081, PHONE WIRE SHORT 8-71-89500 Cables 1071, PHONE WIRE LONG 8-71-89501 Aurical Aud...
  • Page 33 Accessory Details Group/Family Cables USB cables (for ACP) (2m) 8-71-79200 Cables Power cord, UK 8-71-80200 Cables Aurical Aud Line Filter 28600103 Software license MOLM basic license for audiometer 8-69-45646 Software license MOLM license Finnish matrix 8-69-45647 Software license 2066 TEN Test License...
  • Page 34 Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems Aurical Aud is intended for use in the electromagnetic environment specified below. The user of Aurical Aud should ensure that it is used in such an envir- onment.
  • Page 35 Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems Aurical Aud is intended for use in the electromagnetic environment specified below. The user of Aurical Aud should ensure that it is used in such an envir- onment.
  • Page 36 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment Aurical Aud is intended for use in the electromagnetic environment specified below. The user of Aurical Aud should ensure that it is used in such an envir- onment.
  • Page 37 Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems Aurical Aud is intended for use in the electromagnetic environment specified below. The user of Aurical Aud should ensure that it is used in such an envir- onment.
  • Page 38 Recommended separation distances between portable and mobile RF communications equipment and Aurical Aud The Aurical Aud is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Aur- ical Aud can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aurical Aud as recommended below, according to the maximum output power of the communications equipment.

  • Page 39: Definition Of Symbols

    Date of man- Indicates the date when 1:2016 Refer- be used with medical device ufacture the medical device was ence no. labels, labelling and inform- manufactured. 5.1.3. (ISO ation to be supplied – Part 1: 7000-2497) General requirements. Aurical Aud...
  • Page 40 Medical devices —Symbols to Humidity lim- Indicates the range of 1:2016 Refer- be used with medical device itations (storage) humidity to ence no. labels, labelling and inform- which the medical device 5.3.8. (ISO ation to be supplied. can be safely exposed. 7000-2620) Aurical Aud...
  • Page 41 Table D.1 such as warnings and pre- symbol 10 Medical electrical equipment cautions that cannot, for a — Part 1: General require- variety of reasons, be ments for basic safety and presented on the medical essential performance. device itself. Aurical Aud...
  • Page 42 NOTE on ME EQUIPMENT D.2, Safety essential performance. "Follow instructions for sign 10 (ISO use” 7010-M002) ISO 7000 Graphical symbols for use on This way up equipment - registered sym- Reference bols no. 0623 Aurical Aud...
  • Page 43 Brazil in accordance with: ANSI/AAMI ES60601-1:2005/ (R)2012 IEC 60601-1-6 CAN/CSA-C22.2 No. 60601-1:14 CAN/CSA-C22.2 No. 60601-1-6 China RoHS 2 Restriction of 6 hazardous Marking substances for electronic and electrical products sold in the People’s Republic of China Aurical Aud...

  • Page 44: Warnings, Cautions, And Notes

    Directive 2012/19/EU. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made.
  • Page 45 In case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device. Warning Refer to the manufacturer's declaration for electromagnetic emissions for all equipment and systems • described in this manual. Warning • Any incorrect handling of Aurical Aud can affect this device's performance. Aurical Aud...
  • Page 46 This device contains a Type BF applied part symbol. Refer to the Definition of Symbols section for more • information. Warning • Do not connect this device to other devices that do not comply with the safety and EMC standards described in this manual. Aurical Aud...
  • Page 47 19.3 General cautions Caution Aurical Aud requires regular maintenance to continue operating as intended. This includes visual • inspection, cleaning, and calibration. If the equipment shows signs of damage or material degradation, do not use the device and contact your supplier.

  • Page 48: Manufacturer

    Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to • the competent authority of the country or the EU Member State in which the user and/or patient is established Manufacturer Natus Medical Denmark ApS Hoerskaetten 9, 2630 Taastrup Denmark +45 45 75 55 55 www.natus.com...

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