Interacoustics affinity 2.0 Instructions For Use Manual
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Interacoustics affinity 2.0 Instructions For Use Manual

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Instructions for Use – US
2.0
Affinity
Hearing Aid Analyzer
D-0004578-G – 2016/06

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  • Page 1 Instructions for Use – US Affinity Hearing Aid Analyzer D-0004578-G – 2016/06...

  • Page 3: Table Of Contents

    The HIT440 Screen ......................42 Using the Print Wizard ...................... 48 MAINTENANCE ......................... 51 General Maintenance Procedures ..................51 How to clean Interacoustics Products ................51 Concerning Repair ......................52 Warranty ..........................52 GENERAL TECHNICAL SPECIFICATIONS ................53 Reference Equivalent Threshold Values for transducers ..........54 Pin Assignments .......................

  • Page 5: Introduction

    Affinity Instructions for Use – US Page 1 1 Introduction 1.1 About this Manual This manual is valid for the Affinity2.0 . These products are manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax:...

  • Page 6: Included And Optional Parts And Accessories

    Affinity Instructions for Use - US Page 2 1.4 Included and Optional Parts and Accessories AC440 REM440 HIT440 Included parts: Included parts: Included parts: • • • Affinity2.0 AC440 CD Affinity2.0 REM440 CD Affinity2.0 HIT440 CD • • • OtoAccess™ database CD OtoAccess™...

  • Page 7: Warnings

    Affinity Instructions for Use - US Page 3 Optional special tests: • High Frequency audiometry (HF440) • Multi Frequency module (MF440) • Speech from hard-drive (SFH440) • SISI test • Master Hearing Aid (MHA440), • Hearing Loss Simulator (HLS440) • Loudness Scaling (LS440) •...
  • Page 8 Affinity Instructions for Use - US Page 4 6. If connection is made to standard equipment like an active speaker, special precautions must be taken in order to maintain medical safety. If used without galvanic separation, it must be supplied from a medical isolation transformer fulfilling the requirements of IEC/ES 60601-1.

  • Page 9: Unpacking And Installation

    Affinity Instructions for Use - US Page 5 2 Unpacking and Installation 2.1 Unpacking and Inspection Check box and contents for damage When the instrument is received please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically.

  • Page 10: Marking

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

  • Page 11: Connection Panel Dictionary

    Affinity Instructions for Use - US Page 7 2.3 Connection Panel Dictionary Position: Symbol: Function: Connection of FF1 Connection of FF2 Left Plug for left AC headphone Right Plug for right AC headphone Ins. Left Plug for left insert earphone Ins.

  • Page 12: Software Installation

    2.4 Software installation To know before you Start Installation You must have administrative rights to the computer on which you are installing the Affinity 2.0/ Equinox 2.0 Suite. 1. DO NOT connect the Affinity2.0 hardware to the computer before the software has been installed! 2.

  • Page 13: Software Installation Windows®7 And Windows®8

    Affinity Instructions for Use - US Page 9 2.4.1 Software Installation Windows®7 and Windows®8 Insert the installation DVD and follow the steps below to install the Affinity2.0/Equinox2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD.
  • Page 14 Affinity Instructions for Use - US Page 10 3. The installer will now copy all the necessary files to the PC. This process may take several minutes. 4. If the dialog box below appears, select “Install” to install this driver software.
  • Page 15 Affinity Instructions for Use - US Page 11 5. When the installation is complete, the dialog box below is shown. 6. Click “Close” to finish the installation. The Affinity2.0/Equinox2.0 Suite is now installed.

  • Page 16: Software Installation Windows®8.1/ Windows®10

    Affinity Instructions for Use - US Page 12 2.4.2 Software Installation Windows®8.1/ Windows® 10 Insert the installation DVD and follow the steps below to install the Affinity2.0/Equinox2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD.
  • Page 17 Affinity Instructions for Use - US Page 13 3. The installer will now copy all the necessary files to the PC. This process may take several minutes. 4. If any of the dialogs below are shown, click “Install” to proceed with the installation.
  • Page 18 Affinity Instructions for Use - US Page 14...
  • Page 19 Affinity Instructions for Use - US Page 15 5. When the installation is complete, the dialog box below is shown. 6. Click “Close” to finish the installation. The Affinity2.0/Equinox2.0 Suite is now installed.

  • Page 20: Driver Installation

    Affinity Instructions for Use - US Page 16 2.5 Driver Installation Now that the Affinity 2.0 / Equinox 2.0 Suite software is installed, you must install the driver for the hardware. For Windows ® 7/8/8.1/10: 1. Connect the Affinity 2.0 / Equinox 2.0 hardware to the PC via the USB connection.

  • Page 21: Using With Databases

    Affinity Instructions for Use - US Page 17 2.6 Using with Databases 2.6.1 Noah3 If you are using HIMSA’S Noah3 and you want a button shortcut for the installed module, please follow these steps. 1. Start Noah3 2. Go to the menu item “Tools” 3.

  • Page 22: Standalone Version

    You can find the executable file (.exe) for this purpose through the following path start/All Programs/Interacoustics/Suite for Affinity2.0 Suite Launcher. Right click on the last item with the mouse and select “Create shortcut”. However, you will not be able to save your recordings when using this way of working.

  • Page 23: Operating Instructions

    Affinity2.0 Instructions for Use - US Page 19 3 Operating instructions The instrument is switched by the switch on the rear. When operating the instrument, please observe the following general precautions: 1. The intended operators of the instrument are ENT doctors, Audiologists and other professionals with similar knowledge.

  • Page 24: Using The Tone Screen

    Affinity Instructions for Use - US Page 20 3.1 Using the Tone Screen The following section describes the elements of the tone screen. Menu provides access to Print, Edit, View, Tests, Setup, and Help Print allows for printing the session’s acquired data. Save &...
  • Page 25 Affinity Instructions for Use - US Page 21 To switch on the extended range automatically, select the Switch extended range on automatically by going to the setup menu. Fold an area so that it only shows the label or the buttons of that area. Unfold an area so that all buttons and labels are visible Show/hide areas can be found by right mouse clicking on one of the areas.
  • Page 26 Affinity Instructions for Use - US Page 22 Edit Mode button activates the editing function. Left clicking on graph will add/move a point to position of the cursor. If right clicking on a specific stored point a context menu appears offering you the following options: Mouse controlled audiometry enables you to do the audiometry using...
  • Page 27 After saving the session, 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. The Output list for channel 1 provides the option to test through head phones, bone conductor, free field speakers or insert phones.
  • Page 28 Affinity Instructions for Use - US Page 24 Pulsation allows for single and continuous pulsating presentation. The duration of the stimulus can be adjusted in the AC440 setup. Sim/Alt allows toggling between Simultaneous and Alternate presentation. Ch1 and Ch2 will present the stimulus simultaneously when Sim is selected.
  • Page 29 Affinity Instructions for Use - US Page 25 The hardware indication picture indicates whether the hardware is connected. Simulation mode is indicated when operating the software without hardware. When opening the Suite the system will automatically search for the hardware. If it does not detect the hardware a dialog box pops up and asks if you want to continue in simulation mode.

  • Page 30: Using The Speech Screen

    Affinity Instructions for Use - US Page 26 3.2 Using the Speech Screen The following section describes the elements of the speech screen in addition to the tone screen: Input levels sliders allow for adjusting the input level to 0 VU for the selected input.
  • Page 31 Affinity Instructions for Use - US Page 27 The Output list for channel 1 provides the option to test through the desired transducers. Note that the system only shows the calibrated transducers. The Input list for channel 1 provides the option to select white noise (WN), speech noise (SN), microphone 1 or 2 (Mic1 and Mic2), CD1, CD2 and wavefile.

  • Page 32: Speech Audiometry In Graph Mode

    Affinity Instructions for Use - US Page 28 3.2.1 Speech Audiometry in Graph Mode Graph mode presentation settings under “Test Symbols” and in the presentation options (Ch1 and Ch2) in the upper part of the screen shows where you can adjust the test parameters during the test. 1) The graph: The curves of the recorded speech graph will be displayed on your screen.

  • Page 33: Speech Audiometry In Table Mode

    Affinity Instructions for Use - US Page 29 3.2.2 Speech Audiometry in Table Mode The AC440 Table Mode consists of two tables: The SRT (Speech Reception Threshold) table. When the SRT test is active, it is indicated in orange The WR (Word Recognition) table. When WR1, WR2, or WR3 is active the corresponding label will be orange The SRT table The SRT table (Speech Reception Threshold table) allows for measuring multiple SRTs using different test...
  • Page 34 Affinity Instructions for Use - US Page 30 The WR Table The word recognition (WR) table allows for measuring multiple WR scores using different parameters (e.g. Transducer, Test Type, Intensity, Masking, and Aided). Upon changing Transducer, Masking, and/or Aided re-testing an additional WR entry will appear in the WR table.

  • Page 35: Pc Keyboard Shortcuts Manager

    Affinity Instructions for Use - US Page 31 3.2.3 PC Keyboard Shortcuts Manager The PC Shortcut Manager allows the user to personalize PC shortcuts in the AC440 Module. To access the PC Shortcut Manager: Go to AUD module │Menu │ Setup │PC Shortcut Keys To view the default shortcuts, click on the items in the left hand column (Common 1, Common 2, Common 3, etc.) To personalize a shortcut, click on the column in the middle and add the custom shortcut in the field on the...
  • Page 36 Page 32 Technical Specifications of the AC440 Software Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123.

  • Page 37: The Rem440 Screen

    Affinity Instructions for Use - US Page 33 3.3 The REM440 Screen The following section describes the elements of the REM screen: Menu provides access to File, Edit, View, Mode, Setup, and Help. Print button will print the test results using the selected print template. If no print template is selected the results currently displayed on the screen will be printed.
  • Page 38 After saving the session, 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. Single Frequency button is a test that lets the fitter play a single frequency warble tone.
  • Page 39 Affinity Instructions for Use - US Page 35 On Top Mode button converts the REM440 into an on top window that includes only the most essential REM features. The window is automatically placed on top of other active software programs such as the relevant hearing aid fitting software.
  • Page 40 Affinity Instructions for Use - US Page 36 Simple View/Advanced View buttons toggle between an advanced screen view (including the test and fitting prescription information on the right hand side) and a more simple view with a larger graph only. Normal and Reversed Coordinate System buttons enable you to toggle between reversed and normal graph displays.
  • Page 41 Connect a monitor headset to the monitor output on the hardware. It is recommended to use only a monitor headset which is approved by Interacoustics. Tick the Monitor check box. Use the slider to turn the sound level up and down.
  • Page 42 Affinity Instructions for Use - US Page 38 Press START in the software and then tick the External sound check box. The external sound will then play with the signal. Use the slider to turn the sound level up and down. Note that in Visible Speech Mapping you can select Live Voice and then play an external sound.
  • Page 43 Affinity Instructions for Use - US Page 39 Measurement Details of the selected curve are displayed as a table on the right hand side of the screen. A Curve Comment for each curve can be typed into the comment section on the right hand side. Select a curve using the curve tag boxes under Curve display options and write a comment in the comment section.
  • Page 44 Affinity Instructions for Use - US Page 40 Enable/Disable Icons This feature lets the fitter customize which buttons appear on the front of the main REM440 screen. When all the items are selected with the checkmark, all buttons will be displayed on the front screen.
  • Page 45 Page 41 REM440 Software - Technical Specifications Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123.

  • Page 46: The Hit440 Screen

    Affinity Instructions for Use - US Page 42 3.4 The HIT440 Screen The following section describes the elements of the HIT screen Menu provides access to Print, Edit, View, Mode, Setup, and Help. Print button allows you to print only the test results currently displayed on the screen.
  • Page 47 Affinity Instructions for Use - US Page 43 Temporary Setup button allows for making temporary changes to the selected test protocol. The changes will be valid for the current session only. After making the changes and returning to the main screen, the name of the test protocol will be followed by an asterisk (*).
  • Page 48 Affinity Instructions for Use - US Page 44 the curve and a frequency and intensity label will be displayed at the curser’s position, as illustrated below: Stimulus Selection allows for selecting a test stimulus. The dropdown is only present for custom made test protocols. The standards (e.g.
  • Page 49 Affinity Instructions for Use - US Page 45 Start/Stop button initiates and ends all tests. Note that after pressing START the text on the button will change to STOP. The Graph shows measured HIT curves. The X axis shows the frequency and the Y axis shows ouput or gain, depending on which measurement was done.
  • Page 50 Affinity Instructions for Use - US Page 46 Curve Display Options are found in the lower right hand corner. If you have measured more curves of the same type (e.g. Frequency response curves), they will be listed by their input level. Tick the ones that are to be displayed on the graph.
  • Page 51 Page 47 HIT440 Software - Technical Specifications Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123.

  • Page 52: Using The Print Wizard

    Affinity Instructions for Use - US Page 48 3.5 Using the Print Wizard In the Print Wizard you have the option to create customized print templates which can be linked to individual protocols for quick printing. The Print Wizard can be reached in two ways. a.
  • Page 53 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 to the Callisto Additional Information document or the Print Report Quick Guide on www.interacoustics.com...
  • Page 54 Affinity Instructions for Use - US Page 50...

  • Page 55: Maintenance

    The instrument must go through at least one annual overhaul, to ensure that the acoustical, electrical and mechanical properties are correct. This should be made by an authorised technician in order to guaranty proper service and repair as Interacoustics provides the necessary circuit diagrams etc. to these technicians.

  • Page 56: Concerning Repair

    Page 52 4.3 Concerning Repair Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if: 1. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised persons, 2.

  • Page 57: General Technical Specifications

    5 General Technical Specifications Affinity2.0 Hardware - Technical Specifications Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC Approval of the quality system is made by TÜV – identification no. 0123.

  • Page 58: Reference Equivalent Threshold Values For Transducers

    Affinity Instructions for Use - US Page 54 Sp. 1-4 Power Out 70Hz-20kHz ±3dB Voltage: 5VDC Current: 0.5A TB Loop Up to 100mA/meter 70Hz-20kHz ±3dB FF Loop Batt. Sim. Voltage: 1.1 – 1.6VDC Impedance range: 0 – 25 Ω. Batt. Sim. - Internal TB (Affinity2.0 only) Data Connections...
  • Page 59 Affinity 2 RETSL-HL tabel 5.1 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 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω...
  • Page 60 Affinity 2 RETSL-HL tabel Pure Tone max HL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 61 Affinity 2 RETSL-HL tabel NB noise effective masking level Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω...
  • Page 62 Affinity 2 RETSL-HL tabel NB noise max HL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 63 Affinity 2 RETSL-HL tabel 5.2 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 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω...
  • Page 64 Affinity 2 RETSL-HL tabel IEC Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 65 Affinity 2 RETSL-HL tabel Sweden Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 10 Ω 10 Ω 37 Ω 40 Ω 23 Ω 60 Ω 10 Ω 10 Ω 10 Ω 68 Ω 10 Ω...
  • Page 66 Affinity 2 RETSL-HL tabel Norway Speech RETSPL Transducer DD45 TDH39 HDA280 HDA200 HDA300 Koss R80 EAR3A IP30 EAR5A CIR22/33 BKH10 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 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 68 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 Binaural Free Field Power Free Field Line Free Field Intern Monaural 0° - 45° - 90° 0°...
  • Page 69 Affinity 2 RETSL-HL tabel Sound attenuation values for earphones Frequency Attenuation TDH39/DD45 with MX41/AR EAR 3A IP30 HDA200 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 71 5.2 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 72 Sp. 1-4 Power Out Insitu L & R Speaker 1 - Ground Speaker 2 - Speaker signal Speaker 3 - Ground Speaker 4 - DC bias – Probe mic. Signal & DC bias – Ref. mic. Speaker 1 + Speaker 2 + Ground Speaker 3 + Signal - Probe mic.
  • Page 73 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 74 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 lines 40% UT (60% dip in UT) 40% UT (60% dip in UT) for commercial or residential for 5 cycles 5 cycles environment.
  • Page 75 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:

Affinity2.0Equinox2.0

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