Interacoustics Affinity Compact Instructions For Use Manual
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Interacoustics Affinity Compact Instructions For Use Manual

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Science made smarter
Instructions for Use - EN
Affinity
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Summary of Contents for Interacoustics Affinity Compact

  • Page 1 Science made smarter Instructions for Use - EN Affinity Compact...

  • Page 3: Table Of Contents

    The HIT440 screen ......................46 3.4.1 HIT440 Software - Technical Specifications ............50 Using the print wizard ......................52 MAINTENANCE ......................... 55 General maintenance procedures ..................55 How to clean Interacoustics products ................55 Concerning repair ......................56 Warranty ..........................56...
  • Page 4 GENERAL TECHNICAL SPECIFICATIONS ................57 Affinity Compact Hardware - Technical Specifications ............57 Tone reference equivalent threshold values for transducers ..........59 Pin assignments ........................ 72 Electromagnetic compatibility (EMC) ................74...

  • Page 5: Introduction

    The Affinity Compact with HIT440 is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting.

  • Page 6: Included And Optional Parts And Accessories

    • Cable Extender Box • • Sound room kit OtoAccess® database • Applied part according to IEC 60601-1 This part is not certified according to IEC 60601-1 D-0123234-D – 2020/05 Page 2 Affinity Compact - Instructions for Use - EN...
  • Page 7 D-0123234-D – 2020/05 Page 3 Affinity Compact - Instructions for Use - EN...

  • Page 8: Warnings And Precautions

    NOTICE is used to address practices not related to personal injury. Federal law restricts this device to sale by or on the order of a licensed medical practitioner D-0123234-D – 2020/05 Page 4 Affinity Compact - Instructions for Use - EN...

  • Page 9: 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 Affinity Compact for a period, please ensure it is stored under the following conditions: Temperature;...

  • Page 10: Symbols

    This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recycling. 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.

  • Page 11: Important Safety Instructions

    The requirement for the Separation Device is defined in IEC 60601-1 clause 16 2.3.2 Electrical safety Do not modify this equipment without authorization of Interacoustics Do not WARNING disassemble or modify the product as this may impact on the safety and/or performance of the device.

  • Page 12: Explosion Hazards

    EMC. Use of accessories, transducers and cables other than specified, with the exception of transducers and cables sold by Interacoustics or representatives, may result in increased emission or decreased immunity of the equipment. For a list of accessories, transducers and cables that fulfil the requirements please also refer to the appendix regarding EMC.

  • Page 13: Environmental Factors

    Interacoustics A/S cannot be held liable for your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsoft.
  • Page 14 Outside the European Union, local regulations should be followed when disposing of the product after end of life. D-0123234-D – 2020/05 Page 10 Affinity Compact - Instructions for Use - EN...

  • Page 15: Connection Panel Dictionary

    Socket for USB connection to PC Position: Symbol: Function: Reference Socket for Reference Microphone Coupler Socket for Coupler Microphone Battery Socket for Battery Simulator power out Telecoil Socket for Telecoil out D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 11...

  • Page 16: Affinity Compact Indicators

    Indicates that the Affinity Compact is not correctly connected to the Affinity Compact Suite A dimmed light indicates that the Affinity Compact has entered power saving mode. This can happen in any of the colours mentioned above. 2.6 Software installation To know before you Start the Installation You must have administrative rights to the computer on which you are installing the Affinity Compact Suite.

  • Page 17: Software Installation Windows®7

    2.6.1 Software installation Windows®7 Insert the installation USB and follow the steps below to install the Affinity Compact Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB. Double click the “AffinitySuiteSetup.exe” file to initiate the installation.
  • Page 18 ’Options’ ahead of ’Install’ 2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 14...
  • Page 19 3. The installer will now copy all the necessary files to the PC. This process may take several minutes. 4. When the installation is complete, the dialog box below is shown. 5. Click “Close” to finish the installation. The Affinity Compact/Equinox Suite is now installed. D-0123234-D – 2020/05...

  • Page 20: Software Installation Windows®8.1

    You must also accept the license terms and conditions ahead of installing. On checking the box to accept this, the Install button will become available, click “Install” to begin the installation. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 16...
  • Page 21 ‘Options’ ahead of ‘Install’. 2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 17...
  • Page 22 3. The installer will now copy all the necessary files to the PC. This process may take several minutes. 4. When the installation is complete, the dialog box below is shown. 5. Click “Close” to finish the installation. The Affinity Compact Suite is now installed. D-0123234-D – 2020/05...

  • Page 23: Software Installation Windows®10

    2.6.3 Software installation Windows®10 Insert the installation USB and follow the steps below to install the Affinity Compact Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the USB/CD-RW drive to view the contents of the installation USB. Double click the “Affinity CompactSuiteSetup.exe”...
  • Page 24 ‘Options’ ahead of ‘Install’. 2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 20...
  • Page 25 3. The installer will now copy all the necessary files to the PC. This process may take several minutes. 4. When the installation is complete, the dialog box below is shown. 5. Click “Close” to finish the installation. The Affinity Compact Suite is now installed. D-0123234-D – 2020/05...

  • Page 26: Driver Installation

    2.8 Using with databases 2.8.1 Noah 4 If you are using HIMSA’s Noah 4, the Affinity Compact software will install itself automatically in the menu bar on the start page, along with all the other software modules. Working with OtoAccess®...

  • Page 27: License

    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-0123234-D – 2020/05 Page 23 Affinity Compact - Instructions for Use - EN...

  • Page 28: Operating Instructions

    Using the instrument without adequate knowledge may lead to erroneous results and may endanger the patients hearing. 2. The Affinity Compact 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 29: Using The Tone Screen

    Note that the extended range button will flash when it needs activation for reaching higher intensities. To switch on the extended range automatically, select the Switch extended range on automatically by going to the setup menu. D-0123234-D – 2020/05 Page 25 Affinity Compact - Instructions for Use - EN...
  • Page 30 Right mouse click on a protocol allows the current examiner to set or deselect a default startup protocol. Please refer to the Affinity Compact “Additional Information” document for more information on protocols and protocol setup. Temporary Setup allows for making temporary changes to the selected protocol.
  • Page 31 The Patient monitor opens an always-on-top window with the tone audiograms and all its counselling overlays shown. The size and position of the patient monitor gets saved for each examiner individually. D-0123234-D – 2020/05 Page 27 Affinity Compact - Instructions for Use - EN...
  • Page 32 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 33 This can also be obtained using the left and right arrow keys on the PC keyboard. TENs test requires an additional license for the AC440. If not purchased, the stimulus is grayed out. D-0123234-D – 2020/05 Page 29 Affinity Compact - Instructions for Use - EN...
  • Page 34 An examiner can also select which protocol must be selected at start up (by right mouse click on the protocol selection list). D-0123234-D – 2020/05 Page 30 Affinity Compact - Instructions for Use - EN...

  • Page 35: Using The Speech Screen

    Binaural and Aided function allows for indicating if the test is performed binaurally or while the patient is wearing hearing aids. This feature is only active in the Speech Audiometry screen. D-0123234-D – 2020/05 Page 31 Affinity Compact - Instructions for Use - EN...
  • Page 36 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-0123234-D – 2020/05 Page 32 Affinity Compact - Instructions for Use - EN...

  • Page 37: 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-0123234-D – 2020/05 Page 33 Affinity Compact - Instructions for Use - EN...

  • Page 38: Speech Audiometry In Table Mode

    Upon changing Transducer, Masking, and/or Aided and re-testing, an additional SRT entry will appear in the SRT table. This allows for multiple SRT measurements to be shown in the SRT table. Please refer to the Affinity Compact Additional Information document for more information about SRT testing. D-0123234-D – 2020/05...
  • Page 39 3. Click on the Binaural button if the test is done in the Free Field so that the results are stored for both ears at the same time 4. Proceed with test; results will then be stored as aided by showing an Aided icon D-0123234-D – 2020/05 Page 35 Affinity Compact - Instructions for Use - EN...

  • Page 40: Pc Keyboard Shortcuts Manager

    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-0123234-D – 2020/05 Page 36 Affinity Compact - Instructions for Use - EN...

  • Page 41: Technical Specifications Of The Ac440 Software

    3.2.4 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 42 Storing capability: Tone audiogram: dB HL, MCL, UCL, Tinnitus. Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural. Compatible software: Noah 4, OtoAccess and XML compatible ® D-0123234-D – 2020/05 Page 38 Affinity Compact - Instructions for Use - EN...

  • Page 43: The Rem440 Screen

    In other words the curve freezes at a particular moment while the test continues. NOTE: The Freeze Curve option only works for broadband (ex: ISTS) signals in the continuous mode. D-0123234-D – 2020/05 Page 39 Affinity Compact - Instructions for Use - EN...
  • Page 44 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 45 Note that the calibration is sensitive to noise and the clinician should therefore ensure that the room is quite while calibrating. D-0123234-D – 2020/05 Page 41 Affinity Compact - Instructions for Use - EN...
  • Page 46 Table View button provides a chart view of the measured and target values. Show Cursor on Graph locks the cursor to the curve, displaying the frequency and intensity at any given point along the measure curve. D-0123234-D – 2020/05 Page 42 Affinity Compact - Instructions for Use - EN...
  • Page 47 Scroll Graph Up/Down on the left hand side allows for scrolling the graph up or down ensuring that the curve is always visible in the middle of the screen. D-0123234-D – 2020/05 Page 43 Affinity Compact - Instructions for Use - EN...
  • Page 48 Tick the ones that are to be displayed on the graph. Right clicking on the input level in the curve display will give the fitter various options. D-0123234-D – 2020/05 Page 44 Affinity Compact - Instructions for Use - EN...
  • Page 49 Simulation icon (above right) will show in place of the connected hardware indication picture (above left). D-0123234-D – 2020/05 Page 45 Affinity Compact - Instructions for Use - EN...

  • Page 50: Rem Software - Technical Specifications

    3.3.1 REM 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. Real Ear Measurement IEC 61669:2015, ANSI S3.46:2013...

  • Page 51: The Hit440 Screen

    (ex: ISTS) signals in the continuous mode. List of Protocols allows you to select a test protocol (default or user defined) to use in the current test session. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 47...
  • Page 52 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. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 48...
  • Page 53 Test protocols can be created and adjusted in the HIT440 Setup. Start/Stop button initiates and ends all tests. Note that after pressing START the text on the button will change to STOP. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 49...
  • Page 54 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. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 50...

  • Page 55: Hit440 Software - Technical Specifications

    Zinc air 312 Zinc air 675 Mercury 13 Mercury 312 Mercury 657 Mercury 401 Silver 13 Silver 312 10.0 Silver 76 Custom types 0 – 25 1.1 – 1.6 D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 51...
  • Page 56 Microphone Directionality Reference Test Gain Coil Frequency Response Frequency Response Coil Harmonic Distortion Equivalent Input Noise Coil Full-On Gain Response Compatible software: Noah 4, OtoAccess® and XML compatible D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 52...

  • Page 57: Using The Print Wizard

    If you want to use a template for general use, or select an existing one for printing: Go to Menu/ File/Print Layout… in any of the Affinity Compact Suite tabs (AUD, REM or HIT) b. If you want to create a template or select an existing one to link to a specific protocol: Select the Module tab (AUD, REM, or HIT) relating to the specific protocol and select Menu/Setup/AC440 setup, Menu/Setup/REM440 setup, or Menu/Setup HIT440 setup.
  • Page 58 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 Affinity Compact Additional Information document or the Print Report Quick Guide on www.interacoustics.com...
  • Page 59 D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 55...

  • Page 60: 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 61: Concerning Repair

    • The Affinity Compact is free from defects in material and workmanship under normal use and service for a period of 24 months from the date of delivery by Interacoustics to the first purchaser • Accessories are free from defects in material and workmanship under normal use and service for...

  • Page 62: General Technical Specifications

    5.1 Affinity Compact 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 63 Input: 100-240VAC 50-60Hz, 1.5 A Output: 24.0 VDC Operation environment Temperature: 15-35°C Re. Humidity: 30-90% Non-condensing Transport and storage Transport temperature: -20-50°C Storage temperature: 0-50°C Re. Humidity: 10-95% Non-condensing D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 59...

  • Page 64: Tone Reference Equivalent Threshold Values For Transducers

    ISO 389-2 1994. B71 / B81 use ANSI S3.13 or IEC60318-6 2007 mechanical coupler and RETFL come from ANSI S3.6 2018 and ISO 389-3 2016 Force 5.4N ±0.5N D-0123234-D – 2020/05 Page 60 Affinity Compact - Instructions for Use - EN...
  • Page 65 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 61...
  • Page 66 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 ISO389-4 1994. D-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 62...
  • Page 67 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 63...
  • Page 68 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 64...
  • Page 69 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 65...
  • Page 70 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 66...
  • Page 71 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 67...
  • Page 72 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 68...
  • Page 73 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-0123234-D – 2020/05 Affinity Compact - Instructions for Use - EN Page 69...
  • Page 74 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-0123234-D – 2020/05 Page 70 Affinity Compact - Instructions for Use - EN...
  • Page 75 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-0123234-D – 2020/05 Page 71 Affinity Compact - Instructions for Use - EN...
  • Page 76 1250 30.8 1500 1600 33.7 2000 43.6 15.1 2500 47.5 3000 3150 41.5 4000 43.8 28.8 5000 46.7 6000 6300 45.7 8000 45.6 26.2 *ISO 8253-1 2010 D-0123234-D – 2020/05 Page 72 Affinity Compact - Instructions for Use - EN...

  • Page 77: Pin Assignments

    Ground D sub HD 26 poles Ground I²C int Tube 2 left mic Ground Tube 1 left mic Tube 2 right mic Ground Tube 1 right mic D-0123234-D – 2020/05 Page 73 Affinity Compact - Instructions for Use - EN...
  • Page 78 I²C clk Ground Not used Insitu left spkr Ground Ground DC bias Ref left mic D-0123234-D – 2020/05 Page 74 Affinity Compact - Instructions for Use - EN...

  • Page 79: Electromagnetic Compatibility (Emc)

    NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction. No further steps required. D-0123234-D – 2020/05 Page 75 Affinity Compact - Instructions for Use - EN...
  • Page 80 Guidance and manufacturer’s declaration - electromagnetic emissions The AFFINITY COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of the AFFINITY COMPACT should assure that it is used in such an environment. Emissions Test...
  • Page 81 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The AFFINITY COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of the AFFINITY COMPACT should assure that it is used in such an environment. Immunity Test...
  • Page 82 Guidance and manufacturer’s declaration — electromagnetic immunity The AFFINITY COMPACT is intended for use in the electromagnetic environment specified below. The customer or the user of the AFFINITY COMPACT should assure that it is used in such an environment, Immunity test...
  • Page 83 Monitor Headset w. microphone Monitor Headset High End Microphone Electret Microphone, grey clip-on type. ½” Coupler Microphone 0.17 Ref Microphone 0.07 Patient response switch Loudspeaker USB cable (PC) D-0123234-D – 2020/05 Page 79 Affinity Compact - Instructions for Use - EN...
  • Page 85 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:

Ac440Rem440Vsp440 hit440Vsp440Hit440

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