Interacoustics Equinox Evo Instructions For Use Manual
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Interacoustics Equinox Evo Instructions For Use Manual

Interacoustics Equinox Evo Instructions For Use Manual

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Instructions for Use - US
Equinox Evo
D-0142070-A – 2024/10
Equinox Evo - Instructions for Use - US
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  • Page 1 Science made smarter Instructions for Use - US Equinox Evo D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 1...
  • Page 2 All rights reserved. Information in this document is proprietary to Interacoustics A/S. The information in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any form or by any means without a prior written permission of Interacoustics A/S.

  • Page 3: Table Of Contents

    Standard parts ........................39 Operating instructions ....................... 39 4.3.1 How to charge the Touch Keyboard ..................39 4.3.2 Getting ready for use ......................39 4.3.3 General functionality ......................40 D-0142070-A – 2024/10 Page 3 Equinox Evo - Instructions for Use - US...
  • Page 4 Equinox Evo - Technical Specifications ................56 Tone reference equivalent threshold values for transducers ..........58 Pin assignments ........................ 71 Electromagnetic compatibility (EMC) Equinox Evo ............73 D-0142070-A – 2024/10 Page 4 Equinox Evo - Instructions for Use - US...

  • Page 5: Introduction

    1 Introduction 1.1 About this manual This manual is valid for the Equinox Evo, software version Equinox Suite 2.23. This product is manufactured Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 E-mail: info@interacoustics.com Web: www.interacoustics.com 1.2 Intended use...

  • Page 6: Product Description

    1.3 Product description The Equinox Evo is a PC based 2-channel clinical audiometer (IEC 60645-1:2017, Type 1EHF Class A-E) operated in the software module AC440. The device offers a wide range of audiometric tests, such as Pediatric test, SISI, ABLB, Stenger, Weber, TEN test, Speech in noise, Langenbeck, IA-AMTAS, QuickSIN and MLD.

  • Page 7: Warnings And Precautions

    NOTICE is used to address practices not related to personal injury. For the US only: Federal law restricts this device to sale by or on the order of a licensed medical practitioner. D-0142070-A – 2024/10 Page 7 Equinox Evo - Instructions for Use - US...

  • Page 8: Unpacking And Installation

    Return Report will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction. Storage If you need to store the Equinox Evo for a period, please ensure it is stored under the following conditions: Temperature: 0 °C – 50 °C...

  • Page 9: Markings

    This symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection for facilities for recovery and recycling. The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I.
  • Page 10 Symbol Explanation Transport and storage humidity limitations ETL listing mark Logo Equipment includes radio frequency (RF) transmitters D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 10...

  • Page 11: Important Safety Instructions

    When the equipment is connected to a PC, or similar equipment, beware of not touching the PC and patient simultaneously. 2.3.2 Electrical safety Do not modify this equipment without authorization of Interacoustics. WARNING Do not disassemble or modify the product as this may impact on the safety and/or performance of the device.

  • Page 12: Explosion Hazards

    Portable RF communications equipment (including peripherals such as antenna cables or external antennas) should be used no closer than 30 cm (12 inches) to any part of the Equinox Evo including cables specified by Interacoustics. Otherwise, degradation of the performance of this equipment could result.

  • Page 13: Environmental Factors

    Outside the European Union, local regulations should be followed when disposing of the device after end of life. Any serious incident that has occurred in relation to the device should be reported to Interacoustics and to the competent authority of the Member State in which the user and/or patient is established.

  • Page 14: Malfunction

    2.5 Disposal of the product Interacoustics is committed to ensuring that our products are safely disposed of when they are no longer usable. The cooperation of the user is important to ensure this. Interacoustics therefore expects that local sorting and waste regulations for disposal of electric and electronic equipment are followed, and that the device is not discarded together with unsorted waste.

  • Page 15: Connection Panel Dictionary

    If a system already is calibrated for a phone, insert and HF transducer, Insert masker will not be available. 2.6.2 Talk Back/Ambient-Mic. When using the dedicated microphone from Interacoustics, the Talk Back/Ambient-Mic will socket will work as both a Talk Back microphone as well as an Ambient noise microphone.

  • Page 16: Equinox Evo Indicators

    Ready LIGHT BLUE: The Equinox Evo is not correctly connected to the Equinox Suite. A dimmed light indicates that the Equinox Evo has entered power saving mode. This can happen in any of the colors mentioned above. 2.8 Software installation To know before you start the Installation You must have administrative rights to the computer on which you are installing the Equinox Suite.
  • Page 17 Note: There are also options to include the installation of Interacoustics Universe and Equinox Evo documentation, including Instructions for use, within this step. They are by default checked. Uncheck these boxes if you do not wish installation. You can disable this if you wish.
  • Page 18 The installer will now copy all the necessary files to the PC. This process may take several minutes. When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Equinox Suite is now installed. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 18...

  • Page 19: Driver Installation

    This indicates that the driver is installed, and the hardware is ready for use. 2.10 Use with databases 2.10.1 Noah 4 If you are using HIMSA’s Noah 4, the Equinox Evo software will install itself automatically in the menu bar on the start page, along with all the other software modules. 2.10.2 OtoAccess®...

  • Page 20: Licenses

    It works by checking the file and folder content of your software version. This is using an SHA-256 algorithm. On opening the checksum, you will see a string of characters and numbers, you can copy this by double clicking on it. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 20...

  • Page 21: Operating Instructions

    Using the instrument without adequate knowledge may lead to erroneous results and may endanger the patients hearing. 2. The Equinox Evo should be operated in a quiet environment, so that measurements are not influenced by external acoustic noises. This may be determined by an appropriately skilled person trained in acoustics.

  • Page 22: Using The Tone Screen

    Collapse the left side panel. Go to Tone Audiometry activates the tone screen when in another test. Go to Speech Audiometry activates the speech screen when in another test. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 22...
  • Page 23 High Frequency shows frequencies on the audiogram (up to 20 kHz for the Equinox Evo). However, you will only be able to test in the frequency range the selected headset is calibrated for. High Frequency Zoom activates high frequency testing and zooms in on the high frequency range.
  • Page 24 Toggle Masking Help will activate or deactivate the Masking Help feature. For more information on Masking Help, please refer to the Equinox Evo “Additional Information” or the “Masking Help Quick Guide” documents. Toggle Automasking will activate or deactivate the Automasking feature.
  • Page 25 After saving the session, comment changes can only be made within the same day until the date changes (at midnight). Note: these timeframes are limited by HIMSA and the Noah software and not by Interacoustics. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US...
  • Page 26 PC keyboard. Pediatric noise requires an additional license for the AC440. TENs test requires an additional license for the AC440. If not purchased, the stimulus is grayed out. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 26...
  • Page 27 An examiner can also select which protocol must be selected at start up (by right mouse click on the protocol selection list). D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 27...

  • Page 28: Using The Speech Screen

    Each type of measurement is saved as a separate curve. Binaural and Aided function allows for indicating if the test is performed binaurally or while the patient is wearing hearing aids. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 28...
  • Page 29 On the left the dB value for channel 1 is shown and on the right side for channel 2. In the centre of the current Speech Score in % and the Word Counter monitors the number of words presented during the test. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 29...

  • Page 30: Speech Audiometry In Graph Mode

    3. The shaded area illustrates the maximum intensity the system will allow. The Extended Range +20 dB button can be pressed to go higher. The maximal loudness is determined by the transducer calibration. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 30...

  • Page 31: Speech Audiometry In Table Mode

    UCL (Uncomfortable Loudness Level). These are also highlighted in orange when activated. 2. The WR (Word Recognition) table: When WR1, WR2, or WR3 is active the corresponding label will be orange. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 31...
  • Page 32 MCL (Most Comfortable Level) and UCL (Uncomfortable Loudness level) speech audiometry. Please refer to the Equinox Evo Additional Information document for more information about SRT testing. The WR Table The word recognition (WR) table allows for measuring multiple WR scores using different parameters (e.g.

  • Page 33: Pc Keyboard Shortcuts Manager

    To personalize a shortcut, click on the column in the middle and add the custom shortcut in the field on the right hand of the screen D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 33...
  • Page 34 2. Import shortcuts: Use this function to import shortcuts that have already been exported from another computer. 3. Restore all defaults: Use this function to restore the PC shortcuts to Factory Settings default. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 34...

  • Page 35: Technical Specifications - Ac440 Software

    3.4 Technical Specifications - AC440 software Medical CE-mark: The CE mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV – identification no. 0123.
  • Page 36 Storing capability: Tone audiogram: dB HL, MCL, UCL, Tinnitus. Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural Compatible software: Noah 4, OtoAccess ® D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 36...

  • Page 37: Using The Print Wizard

    5. The template that is attached to the selected protocol when entering the print wizard via the AC440 window is recognized by a checkmark. Press the New Template button to open a new empty template. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 37...
  • Page 38 Right clicking on a specific template provides a drop-down menu offering an alternative method for performing the options as described above: For more information related to the Print reports and Print Wizard, please refer Print Report Quick Guide www.interacoustics.com. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 38...

  • Page 39: Touch Keyboard (Optional)

    4 Touch Keyboard (optional) 4.1 Product description The Touch Keyboard is an optional accessory to the PC based audiometers Equinox Evo and Affinity Compact and cannot be used on its own. It is controlled by the software module AC440, referred to as ‘Suite’...

  • Page 40: General Functionality

    The Device setup tab gives access to Brightness of the screen • Wireless connection (on/off) • Sleep timer • Through ‘About this touch keyboard’ information on serial number, version and • disclaimer D-0142070-A – 2024/10 Page 40 Equinox Evo - Instructions for Use - US...

  • Page 41: Messages

    The Suite is not connected to an audiometer and is running in simulation mode. Insufficient data have been collected User is prompted to adjust masking signal for correct SNR values D-0142070-A – 2024/10 Page 41 Equinox Evo - Instructions for Use - US...

  • Page 42: Tone Audiometry

    Touch the arrow down sign to change settings such as test type, dB stepsize or activation of aided measurement. Upper-right corner: See and access channel 2 settings. Current settings are shown for • intensity level D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 42...
  • Page 43 Turn completely down to turn channel 2 off and deactivate masking. To turn off the Touch Keyboard, push and hold the top buttons on both wheels simultaneously for 3 seconds. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 43...

  • Page 44: Speech Audiometry

    Green and red underlining indicates correct and incorrect repetition respectively. Green box indicates that the word is selected for presentation. Word scoring: use v and x button for correct and incorrect repetition respectively. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 44...

  • Page 45: Troubleshooting

    2. wait some seconds 3. and then hold the 2 top buttons once more for 3 seconds. The screen will turn on again. The Touch Keyboard is now reset. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 45...

  • Page 46: Battery Replacement

    Caution: Risk of damaging the terminals for the battery if removed from the top side of the battery. The battery can now be replaced. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 46...

  • Page 47: Touch Keyboard - Technical Specifications

    Transport temperature: -20 °C – 50 °C Storage temperature: 0 °C – 50 °C Re. Humidity: 10 – 95 % Non-condensing Measured in free space with no obstructions in between. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 47...

  • Page 48: Electromagnetic Compatibility (Emc) Touch Keyboard

    Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below: Description Length Screened (Yes/No) USB cables (PC) 1.9 meter D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 48...
  • Page 49 Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 49...
  • Page 50 IEC 61000-4-39 specified in Table 11 Note: UT is the A.C. mains voltage prior to application of the test level. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 50...
  • Page 51 Interference may occur in the vicinity of equipment marked with the following symbol: D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 51...

  • Page 52: Licenses

    GitHub - espressif/esp-idf: Espressif IoT Development Framework. Official development framework for Espressif SoCs. License: Apache-2.0 license Source Code: GitHub - espressif/esp-idf: Espressif IoT Development Framework. Official development framework for Espressif SoCs. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 52...

  • Page 53: Maintenance

    Make sure not to get moisture in the speaker of the earphones and similar parts • Allow the cleaning solution to dry before turning on the instrument. • D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 53...

  • Page 54: Concerning Repair

    5.4 Warranty Interacoustics warrants that: • The Equinox Evo is free from defects in material and workmanship under normal use and service for a period of 12 months from the date of delivery by Interacoustics to the first purchaser •...

  • Page 55: Replacement Of Consumables

    They are replaced by pressing them on the tube nibble or pulling them off. Foam tips are for single use only. For ordering of new foam tips, please refer to the local Interacoustics distributor. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US...

  • Page 56: General Technical Specifications

    6.1 Equinox Evo - Technical Specifications Medical CE mark The CE mark indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I. Approval of the quality system is made by TÜV – identification no. 0123.
  • Page 57 Re. Humidity: 30 – 90 % Non-condensing Transport and storage Transport temperature: -20 °C – 50 °C Storage temperature: 0 °C – 50 °C Re. Humidity: 10 – 95 % Non-condensing D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 57...

  • Page 58: Tone Reference Equivalent Threshold Values For Transducers

    IP30 2ccm use ANSI S3.7-1995 or IEC 60318-5 coupler (HA-2 with 5mm rigid Tube) and RETSPL comes from ANSI S3.6-2018 and ISO 389-2:1994. B71 / B-81 use ANSI S3.13 or IEC 60318-6:2007 mechanical coupler and RETFL come from ANSI S3.6:2018 and ISO 389-3:2016 Force 5.4N ±0.5N D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 58...
  • Page 59 Tone 8000 Hz Tone 9000 Hz Tone 10000 Hz Tone 11200 Hz Tone 12500 Hz Tone 14000 Hz Tone 16000 Hz Tone 18000 Hz Tone 20000 Hz D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 59...
  • Page 60 NB 20000 Hz White noise 42.5 42.5 TEN noise Effective masking value is RETSPL / RETFL add 1/3 octave correction for Narrow-band noise from ANSI S3.6-2018 or ISO 389-4:1994. D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 60...
  • Page 61 NB 9000 Hz NB 10000 Hz NB 11200 Hz NB 12500 Hz NB 14000 Hz NB 16000 Hz NB 18000 Hz NB 20000 Hz White noise TEN noise D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 61...
  • Page 62 Max. HL Max. HL Max. HL Max. HL Max. HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non- linear White noise in speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 62...
  • Page 63 Max. HL Max. HL Max. HL Max. HL Max. HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non-linear White noise in speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 63...
  • Page 64 Max. HL Max. HL Max. HL Max. HL Max. HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non-linear White noise in speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 64...
  • Page 65 Max. HL Max. HL Max HL Max. HL Max HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non-linear White noise in speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 65...
  • Page 66 Max. HL Max. HL Max HL Max. HL Max HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non-linear White noise in speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 66...
  • Page 67 Max. HL Max HL Max. HL Max HL Speech Speech Equ.FF. Speech Non-linear Speech noise Speech noise Equ.FF. Speech noise Non-linear White noise in 108.5 113.5 speech D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 67...
  • Page 68 0° - 45° - 90° 0° - 45° - 90° RETSPL RETSPL RETSPL RETSPL MAX. SPL MAX. SPL MAX. SPL Speech -5.5 Speech Noise -5.5 Speech WN -1.5 87.5 97.5 82.5 D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 68...
  • Page 69 0° - 45° - 90° 0° - 45° - 90° RETSPL RETSPL RETSPL RETSPL MAX. SPL MAX. SPL MAX. SPL Speech Speech Noise Speech WN -1.5 87.5 97.5 82.5 D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 69...
  • Page 70 28.5 28.2 1000 32.4 1250 30.8 1500 1600 33.7 2000 43.6 2500 47.5 3000 3150 41.5 4000 43.8 5000 46.7 6000 6300 45.7 8000 45.6 *ISO 8253-1:2010 D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 70...

  • Page 71: Pin Assignments

    Signal FF2 line 3.5mm Stereo FF3-4 line out Ground Signal FF3 line Signal FF4 line 3.5mm Stereo Monitor ground Monitor Right Monitor Left Monitor Headset 3.5mm Stereo D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 71...
  • Page 72 Mic. One wire Mic. Bias Talk Back / Ambient Signal 3.5mm 4-pin Common VRA-3 VRA-2 VRA-1 USB connector +5 VDC Data - Data + Ground USB device D-0142070-A – 2024/10 Equinox Evo - Instructions for Use - US Page 72...

  • Page 73: Electromagnetic Compatibility (Emc) Equinox Evo

    6.4 Electromagnetic compatibility (EMC) Equinox Evo The Equinox Evo is suitable in hospital and clinical environments except for near-active HF surgical equipment and RF-shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:...
  • Page 74 Guidance and manufacturer’s declaration - electromagnetic emissions The EQUINOX EVO is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUINOX EVO should assure that it is used in such an environment. Emissions Test...
  • Page 75 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The EQUINOX EVO is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUINOX EVO should assure that it is used in such an environment. Immunity Test...
  • Page 76 Guidance and manufacturer’s declaration — electromagnetic immunity The EQUINOX EVO is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUINOX EVO should assure that it is used in such an environment, Immunity test...

  • Page 77: Return Report

    Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.

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