Interacoustics Affinity2.0 Instructions For Use Manual
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Interacoustics Affinity2.0 Instructions For Use Manual

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Instructions for Use – US
Affinity
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Equinox
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Summary of Contents for Interacoustics Affinity2.0

  • Page 1 Science made smarter Instructions for Use – US Affinity Equinox...

  • Page 3: Table Of Contents

    HIT440 sof tware - technical specif ications ............46 Using the print wizard....................47 MAINTE NANCE ........................ 49 General maintenanc e procedures ................49 How to clean Interacoustics products ................. 49 Concerning repair ..................... 50 Warranty ........................50 Replacement of consumables..................51 4.5.1...

  • Page 5: Introduction

    This ensures the subject is always in receipt of ef fectively functioning hearing instruments. D-0004578-R – 2022/05 Page 1 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 6: Product Description

    Real Ear Measurements (REM440) including Visible Speech Mapping Hearing Instrument Testing (HIT) • PLEASE NOTE – This product is not a sterile device and is not intended to be sterilized bef ore use. D-0004578-R – 2022/05 Page 2 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 7: Included And Optional Parts And Accessories

    Accessory bracket • • OtoAccess® database Optical USB 1.1 isolation • extension cable Applied part as according to IEC60601-1 This part is not certif ied according to IEC 60601-1 D-0004578-R – 2022/05 Page 3 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 8: Warnings

    4. Do not use any additional multiple socket-outlet or extension cord. For saf e setup please ref er to section 5. No modif ication of this equipment is allowed without the authorization of Interacoustics. Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other inf ormation.
  • Page 9 Interacoustics A/S cannot be held liable f or your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsoft. Interacoustics A/S recommends you to always use Microsof t supported operating systems that are kept f ully security updated.

  • Page 10: Malfunction

    In case of death or serious incident in relation to the use of the device, the incident must immediately be reported to Interacoustics and the local national competent authority. D-0004578-R – 2022/05 Page 6 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 11: Unpacking And Installation

    If you need to store the Af f inity2.0/Equinox2.0 for a period, please ensure that it is stored under the conditions specif ied in the section f or technical specif ications. D-0004578-R – 2022/05 Page 7 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 12: Marking

    This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection f acilities f or recycling The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets 0123 the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV –...
  • Page 13 C AN/C SA-C 2 2 .2 No . 6 0 6 0 1 -1 :2 0 Logo Headphones, patient response switches and other accessories shall be plugged into the appropriate connectors as indicated on the rear of the instrument and the overview below: D-0004578-R – 2022/05 Page 9 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 14: Connection Panel Dictionary

    Plug for power supply for optical USB extension cable USB/PC Plug for USB cable or PC Plug for USB cable Not in use Not in use Mains Plug for mains cable Power Turns power on/off. D-0004578-R – 2022/05 Page 10 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 15: Software Installation

    1. DO NOT connect the Af f inity2.0/Equinox2.0 hardware to the computer bef ore the sof tware has been installed! 2. Interacoustics will not make any guarantee to the f unctionality of the system if any other sof tware is installed, with exception of the Interacoustics measurement (AC440/REM440) modules and AuditBase, OtoAccess®, or Noah4 compatible Of f ice Systems or later releases.

  • Page 16: Software Installation Windows®11, Windows®10, Windows®8.1, And Windows®8

    On checking the box to accept this, the Install button will become available, click “Install” to begin the installation. Note: There are also options to include the installation of Interacoustics Universe and Callisto documentation within this step. They are by def ault checked on; you can disable this if you wish.
  • Page 17 Should you wish to install the sof tware to a dif f erent location than the def ault then please click on ’Options’ ahead of ’Install’ D-0004578-R – 2022/05 Page 13 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 18 User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens. The installer will now copy all the necessary f iles to the PC. This process may take several minutes. D-0004578-R – 2022/05 Page 14 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 19 When the installation is complete, the dialog box below is shown. Click “Close” to f inish the installation. The Af f inity2.0 Suite is now installed. D-0004578-R – 2022/05 Page 15 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 20: Driver Installation

    The f ollowing locations are the def ault storage f older f or recovery or standalone databases C:\ProgramData\Interacoustics\Af f inity Suite\ or C:\ProgramData\Interacoustics\Equinox Suite\ but they can be amended via the f ollowing instructions. NOTE: This f eature can be used to change the recovery location when you are working through a database as well as the standalone save location.

  • Page 21: License

    It works by checking the f ile and f older content of your sof tware 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-0004578-R – 2022/05 Page 17 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 22 D-0004578-R – 2022/05 Page 18 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 23: Operating Instructions

    0VU. It is equally important that any f ree f ield installation is calibrated at the site where it is used and under the conditions that exists during normal operation. 10. For maximum electrical saf ety, remove the USB cable when it is lef t unused. D-0004578-R – 2022/05 Page 19 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 24: Using The Tone Screen

    Note that the extended range button will f lash when it needs activation f or reaching higher intensities. To switch on the extended range automatically, select the Switch extended range on automatically by going to the setup menu. D-0004578-R – 2022/05 Page 20 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 25 HF requires an additional license for the AC440. If not purchased, the button is grayed out. MF requires additional license for the AC440. If not purchased, the button is grayed out. D-0004578-R – 2022/05 Page 21 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 26 The Sound examples counselling overlay shows pictures (png-f iles) as they are set up in the protocol that is currently in use. D-0004578-R – 2022/05 Page 22 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 27 Af ter saving the session, comment changes can only be made within the same day until the date changes (at midnight). Note: these timef rames are limited by HIMSA and the Noah sof tware and not by Interacoustics. The Output list f or channel 1 provides the option to test through headphones, bone conductor, f ree f ield speakers or insert phones.
  • Page 28 Notice that the dB dial setting will f lash when trying to go louder than the maximum available intensity. TENs test requires an additional license for the AC440. If not purchased, the stimulus is grayed out. D-0004578-R – 2022/05 Page 24 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 29 An examiner can also select which protocol must be selected at start up (by right mouse click on the protocol selection list). D-0004578-R – 2022/05 Page 25 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 30: Using The Speech Screen

    Each type of measurement is saved as a separate curve. Binaural and Aided f unction allows f or indicating if the test is perf ormed binaurally or while the patient is wearing hearing aids. D-0004578-R – 2022/05 Page 26 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 31 On the lef t the dB value f or channel 1 is shown and on the right side f or 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-0004578-R – 2022/05 Page 27 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 32: 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-0004578-R – 2022/05 Page 28 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 33: Speech Audiometry In Table Mode

    MCL (Most Comf ortable Level) and UCL (Uncomf ortable Loudness level) speech audiometry. Please ref er to the Af f inity2.0/Equinox2.0 Additional Inf ormation document f or more inf ormation about SRT testing. D-0004578-R – 2022/05 Page 29 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 34 3. Click on the Binaural button if the test is done in the Free Field so that the results are stored f or both ears at the same time 4. Proceed with test; results will then be stored as aided by showing an Aided icon D-0004578-R – 2022/05 Page 30 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 35: Pc Keyboard Shortcuts Manager

    2. Import shortcuts: Use this f unction to import shortcuts that have already been exported f rom another computer. 3. Restore all defaults: Use this f unction to restore the PC shortcuts to Factory Settings def ault. D-0004578-R – 2022/05 Page 31 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 36: Technical Specifications Of The Ac440 Software

    Technical specifications of the 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 – identif ication no. 0123.
  • Page 37 Storing capability: Tone audiogram: dB HL, MCL, UCL, Tinnitus, R+L Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural, R+L. Compatible software: Noah 4, OtoAccess® and XML compatible D-0004578-R – 2022/05 Page 33 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 38: The Rem440 Screen

    REM graph. Toggle between Single and Continuous Measurement button toggles between running a single sweep or having a test signal running continuously until pressing STOP. D-0004578-R – 2022/05 Page 34 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 39 Af ter saving the session, changes can only be made within the same day until the date changes (at midnight). Note: these timef rames are limited by HIMSA and the Noah sof tware, and not by Interacoustics. Single Frequency button is a test that lets the f itter play a single f requency warble tone.
  • Page 40 Note that the calibration is sensitive to noise and the clinician should theref ore ensure that the room is quite while calibrating. D-0004578-R – 2022/05 Page 36 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 41 When satisf ied click OK. Table View button provides a chart view of the measured and target values. D-0004578-R – 2022/05 Page 37 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 42 Note that in Visible Speech Mapping you can select Live Voice and then play an external sound. This means that you will have the external sound alone with nothing (except f rom your own voice) interf ering. D-0004578-R – 2022/05 Page 38 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 43 Measurement Details of the selected curve are displayed as a table on the right-hand side of the screen. D-0004578-R – 2022/05 Page 39 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 44 Simulation icon (above right) will show in place of the connected hardware indication picture (above lef t). D-0004578-R – 2022/05 Page 40 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 45: Rem440 Software - Technical Specifications

    REM440 software - technical specifications 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 – identif ication no. 0123.

  • Page 46: The Hit440 Screen

    In other words, the curve f reezes at a particular moment while the test continues. NOTE: The Freeze Curve option only works in an end-user-created protocol, f or broadband (ex: ISTS) signals in the continuous mode. D-0004578-R – 2022/05 Page 42 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 47 Simple view/Advanced view buttons toggle between an advanced screen view (including the test and f itting prescription inf ormation on the right-hand side) and a simpler view with a larger graph. Advanced view Simple view D-0004578-R – 2022/05 Page 43 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 48 2. Press START in the sof tware and then tick the External sound check box. The external sound will then play together with the signal. 3. Use the slider to turn the sound level up and down. D-0004578-R – 2022/05 Page 44 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 49 When opening the Suite, the system will search f or the hardware. If it does not detect the hardware, then the system will automatically continue in simulation mode. D-0004578-R – 2022/05 Page 45 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 50: Hit440 Software - Technical Specifications

    HIT440 software - technical specifications 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 – identif ication no.

  • Page 51: Using The Print Wizard

    5. The template that is attached to the selected protocol when entering the print wizard via the AC440 or REM440 window is recognized by a checkmark. 6. Press the New Template button to open a new empty template. D-0004578-R – 2022/05 Page 47 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 52 For more inf ormation related to the Print reports and Print Wizard, please ref er to the Af f inity2.0/ Equinox2.0 Additional Inf ormation document or the Print Report Quick Guide on www.interacoustics.com D-0004578-R – 2022/05 Page 48 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 53: Maintenance

    • electrical, and mechanical properties are correct. This should be made by an authorised technician to guaranty proper service and repair as Interacoustics provides the necessary circuit diagrams etc. to these technicians. To ensure that the reliability of the instrument is kept, it is recommended that the operator •...

  • Page 54: Concerning Repair

    Concerning repair Interacoustics is only considered to be responsible f or the validity of the CE marking, ef f ects on saf ety, reliability, and perf ormance of the equipment if : 1. assembly operations, extensions, readjustments, modif ications, or repairs are carried out by authorised persons 2.

  • Page 55: Replacement Of Consumables

    They are replaced by pressing them on the tube nibble or pulling them of f . These are single use parts. For ordering of new parts, please ref eree to the local Interacoustics distributor. 4.5.2 Probe tubes The REM probe tubes are used together with the IMH60/IMH65 headset.

  • Page 56: Ear Tips

    They are replaced by pressing them on the SPL60 probe or pulling them of f . The Ear tips are single use. For ordering of new parts, please ref eree to the local Interacoustics distributor. D-0004578-R – 2022/05 Page 52...

  • Page 57: General Technical Specifications

    5 General technical specifications Affinity2.0/Equinox2.0 Hardware - technical specifications 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 – identif ication no. 0123.
  • Page 58 195VA Operation environment Temperature: 15-35° Re. Humidity: 30-90% Non-condensing Ambient pressure range: 98kPa o 104kPa Transport and storage Transport temperature: -20-50°C Storage temperature: 0-50°C Re. Humidity: 10-95% Non-condensing D-0004578-R – 2022/05 Page 54 Affinity2.0/Equinox2.0 - Instructions for Use - US...

  • Page 59: Reference Equivalent Threshold Values For Transducers

    See Appendix A in English in the back of the manual. Pin assignments See Appendix B in English in the back of the manual. Electromagnetic compatibility (EMC) See Appendix C in English in the back of the manual. D-0004578-R – 2022/05 Page 55 Affinity2.0/Equinox2.0 - Instructions for Use - US...
  • Page 61 Affinity 2 RETSL-HL tabel Appendix A: Survey of reference and max hearing level Tone Audiometer. Pure Tone RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω...
  • Page 62 Affinity 2 RETSL-HL tabel Pure Tone max HL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω...
  • Page 63 Affinity 2 RETSL-HL tabel NB noise effective masking level Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω...
  • Page 64 Affinity 2 RETSL-HL tabel NB noise max HL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω...
  • Page 65 Affinity 2 RETSL-HL tabel Maximum hearing level settings provided at each test frequency ANSI Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω...
  • Page 66 Affinity 2 RETSL-HL tabel IEC Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 67 Affinity 2 RETSL-HL tabel Sweden Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 68 Affinity 2 RETSL-HL tabel Norway Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 69 Affinity 2 RETSL-HL tabel Japan Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 70 Affinity 2 RETSL-HL tabel SPL Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 Impedance 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 71 Affinity 2 RETSL-HL tabel Free Field ANSI S3.6-2010 Free Field max SPL ISO 389-7 2005 Free Field max HL is found by subtracting the selected RETSPL value Binaural to Binaural Free Field Power Free Field Line Free Field Internal Monaural 0°...
  • Page 72 Affinity 2 RETSL-HL tabel Sweden Free Field Free Field max SPL ISO 389-7 2005 Free Field max HL is found by subtracting the selected RETSPL value Binaural to Free Field Power Free Field Line Free Field Intern Binaural Monaural 0° - 45° - 90° 0°...
  • Page 73 Affinity 2 RETSL-HL tabel Equivalent Free Field Speech Audiometer TDH39 DD45 HDA280 HDA200/DD450 HDA300 IEC60645-2 1997 PTB – DTU ISO389-8 2004 PTB 2013 2010 ANSI S3.6-2010 Coupler IEC60318-3 IEC60318-3 IEC60318-3 IEC60318-1 IEC60318-1 Frequency -17,5 -21.5 -15,0 -5,0 -12.0 -14,5 -17.5 -14,0 -4,5 -11.5...
  • Page 74 Affinity 2 RETSL-HL tabel Sound attenuation values for earphones Frequency Attenuation TDH39/DD45 with MX41/AR EAR 3A IP30 HDA200/DD450 HDA300 or PN 51 EAR 5A Cushion [Hz] [dB]* [dB]* [dB]* [dB] 12.5 12.7 1000 12.8 1250 1500 1600 2000 15.1 2500 3000 3150 4000...
  • Page 75 Appendix B: Affinity / Equinox Pin assignments Socket Connector Pin 1 Pin 2 Pin 3 Mains Live Neutral Earth IEC C13 Black FF1 / FF2 Loudspeaker Signal Loudspeaker Signal Negative Positive Terminal Block Left, Right Ins. Left, Ins. Right Ground Signal Bone Ins.
  • Page 76 Sp. 1-4 Power Out Insitu L & R Speaker 1 - Ground Speaker 2 - Speaker signal Speaker 3 - Ground Speaker 4 - DC bias – Probe mic. Speaker 1 + Signal & DC bias – Ref. mic. Speaker 2 + Ground Speaker 3 + Signal - Probe mic.
  • Page 77 If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
  • Page 78 interruptions and voltage for 0.5 cycle for 0.5 cycle for 5 sec Mains power quality variations on power supply should be that of a typical 40% UT (60% dip in UT) 40% UT (60% dip in UT) for lines commercial or residential for 5 cycles 5 cycles environment.
  • Page 79 Radioear Stereo Headset Koss R/80 1-2.9 w. coiled cord Insitu Headset Interacoustics IHM60 Monitor Headset Sennheiser w. microphone (Interacoustics: MTH400m) (PC131) Monitor Headset Sennheiser PX30 Microphones: Electret Microphone Interacoustics EMS400 Electret Microphone, grey clip-on type. Interacoustics EM400 ½” Coupler Microphone Interacoustics 0.17...
  • Page 81 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.

This manual is also suitable for:

Equinox2.0Ac440Rem440Hit440

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