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

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Summary of Contents for Interacoustics Affinity Compact

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

  • Page 3: Table Of Contents

    HIT440 Sof tware - Technical Specif ications............48 Using the print wizard....................50 MAINTE NANCE ........................ 53 General maintenanc e procedures ................53 How to clean Interacoustics products ................. 53 Concerning repair ..................... 54 Warranty ........................54 Replacement of consumables..................55 4.5.1...
  • Page 4 4.5.4 Ear tips ......................56 GENERAL TE CHNICAL SPECIFICATIONS ............... 57 Affinity Compact Hardware - Technical Specif ications..........57 Tone ref erence equivalent threshold values f or transducers ........59 Pin assignments ....................... 72 Electromagnetic compatibility (EMC) ................74...

  • Page 5: Introduction

    It considers the unique quality of a subjects’ external auditory canal, thereby the operator can accurately prescribe the device to targeted audibility levels. D-0123672-H – 2022/05 Page 1 Affinity Compact - Instructions for Use - US...

  • Page 6: Product Description

    Real Ear Measurements (REM440) including Visible Speech Mapping Hearing Instrument Testing (HIT440) • PLEASE NOTE – This product is not a sterile device and is not intended to be sterilized bef ore use. D-0123672-H – 2022/05 Page 2 Affinity Compact - Instructions for Use - US...

  • Page 7: Standard And Optional Parts

    This part is not certif ied according to IEC 60601-1 Not included f or Af finity Compact version 1 & 2 Optional part f or Af finity Compact version 2 D-0123672-H – 2022/05 Page 3 Affinity Compact - Instructions for Use - US...

  • 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-0123672-H – 2022/05 Page 4 Affinity Compact - Instructions for Use - US...

  • Page 9: Unpacking And Installation

    If you need to store the Af f inity Compact f or a period, please ensure it is stored under the f ollowing conditions: Temperature; 0-50°C Relative Humidity: 10-95% Non-condensing D-0123672-H – 2022/05 Page 5 Affinity Compact - Instructions for Use - US...

  • Page 10: Symbols

    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 the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV –...

  • Page 11: Important Safety Instructions

    The requirement f or the Separation Device is def ined in IEC 60601-1 clause 16 2.3.2 Electrical safety Do not modif y this equipment without authorization of Interacoustics Do not WARNING disassemble or modif y the product as this may impact on the saf ety and/or perf ormance of the device.

  • Page 12: Explosion Hazards

    EMC. Use of accessories, transducers, and cables other than specif ied, except f or 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 f ulf il the requirements please also ref er to the appendix regarding EMC.

  • Page 13: Environmental Factors

    Connect only accessories purchased f rom Interacoustics to the instrument. Only accessories which have been stated by Interacoustics to be compatible are allowed to be connected to the device. Never insert, or in any way use, the insert headset without a new clean and non-def ective ear-tip.

  • Page 14: Malfunction

    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 Microsof t. Interacoustics A/S recommends you to always use Microsof t supported operating systems that are kept f ully security updated.

  • Page 15: Connection Panel Dictionary

    Socket for line output to FF loudspeaker Insitu Headset Socket for Insitu REM headset UES65-240250SPA3 Socket for external power supply USB-PC Socket for USB connection to PC D-0123672-H – 2022/05 Page 11 Affinity Compact - Instructions for Use - US...

  • Page 16: Affinity Compact Indicators

    Compact Suite A dimmed light indicates that the Af f inity Compact has entered power saving mode. This can happen in any of the colours mentioned above. D-0123672-H – 2022/05 Page 12 Affinity Compact - Instructions for Use - US...

  • Page 17: Software Installation

    1. DO NOT connect the Af f inity Compact 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 system4, OtoAccess®, or Noah4 compatible Of f ice Systems or later releases.

  • Page 18: 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 19 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-0123672-H – 2022/05 Page 15 Affinity Compact - Instructions for Use - US...
  • Page 20 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-0123672-H – 2022/05 Page 16 Affinity Compact - Instructions for Use - US...
  • Page 21 When the installation is complete, the dialog box below is shown. D-0123672-H – 2022/05 Page 17 Affinity Compact - Instructions for Use - US...
  • Page 22 Click “Close” to f inish the installation. The Af f inity Suite is now installed. D-0123672-H – 2022/05 Page 18 Affinity Compact - Instructions for Use - US...

  • Page 23: Driver Installation

    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. 1. Go to C:\Program Files (x86)\Interacoustics\Af f inity Compact Suite 2. In this f older f ind and launch the executable program titled FolderSetupAf f inity Compact.exe or FolderSetupEquinox.exe...

  • Page 24: 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-0123672-H – 2022/05 Page 20 Affinity Compact - Instructions for Use - US...

  • Page 25: 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. D-0123672-H – 2022/05 Page 21 Affinity Compact - Instructions for Use - US...

  • Page 26: 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-0123672-H – 2022/05 Page 22 Affinity Compact - Instructions for Use - US...
  • Page 27 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-0123672-H – 2022/05 Page 23 Affinity Compact - Instructions for Use - US...
  • Page 28 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 f or each examiner individually. D-0123672-H – 2022/05 Page 24 Affinity Compact - Instructions for Use - US...
  • Page 29 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 30 This can also be obtained using the lef t 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-0123672-H – 2022/05 Page 26 Affinity Compact - Instructions for Use - US...
  • Page 31 An examiner can also select which protocol must be selected at start up (by right mouse click on the protocol selection list). D-0123672-H – 2022/05 Page 27 Affinity Compact - Instructions for Use - US...

  • Page 32: 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-0123672-H – 2022/05 Page 28 Affinity Compact - Instructions for Use - US...
  • Page 33 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-0123672-H – 2022/05 Page 29 Affinity Compact - Instructions for Use - US...

  • Page 34: 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-0123672-H – 2022/05 Page 30 Affinity Compact - Instructions for Use - US...

  • Page 35: 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-0123672-H – 2022/05 Page 31 Affinity Compact - Instructions for Use - US...
  • Page 36 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-0123672-H – 2022/05 Page 32 Affinity Compact - Instructions for Use - US...

  • Page 37: 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-0123672-H – 2022/05 Page 33 Affinity Compact - Instructions for Use - US...

  • Page 38: Technical Specifications Of The Ac440 Software

    3.2.4 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 39 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-0123672-H – 2022/05 Page 35 Affinity Compact - Instructions for Use - US...

  • Page 40: The Rem440 Screen

    In other words, the curve f reezes at a particular moment while the test continues. NOTE: The Freeze Curve option only works f or broadband (ex: ISTS) signals in the continuous mode. D-0123672-H – 2022/05 Page 36 Affinity Compact - Instructions for Use - US...
  • Page 41 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 42 Note that the calibration is sensitive to noise and the clinician should theref ore ensure that the room is quite while calibrating. D-0123672-H – 2022/05 Page 38 Affinity Compact - Instructions for Use - US...
  • Page 43 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 f requency and intensity at any given point along the measure curve. D-0123672-H – 2022/05 Page 39 Affinity Compact - Instructions for Use - US...
  • Page 44 Scroll Graph Up/Down on the lef t-hand side allows f or scrolling the graph up or down ensuring that the curve is always visible in the middle of the screen. D-0123672-H – 2022/05 Page 40 Affinity Compact - Instructions for Use - US...
  • Page 45 Tick the ones that are to be displayed on the graph. Right clicking on the input level in the curve display will give the f itter various options. D-0123672-H – 2022/05 Page 41 Affinity Compact - Instructions for Use - US...
  • Page 46 Simulation icon (above right) will show in place of the connected hardware indication picture (above lef t). D-0123672-H – 2022/05 Page 42 Affinity Compact - Instructions for Use - US...

  • Page 47: Rem Software - Technical Specifications

    3.3.1 REM 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 48: The Hit440 Screen

    (ex: ISTS) signals in the continuous mode. List of Protocols allows you to select a test protocol (def ault or user def ined) to use in the current test session. D-0123672-H – 2022/05 Page 44 Affinity Compact - Instructions for Use - US...
  • Page 49 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. D-0123672-H – 2022/05 Page 45 Affinity Compact - Instructions for Use - US...
  • Page 50 Test protocols can be created and adjusted in the HIT440 Setup. Start/Stop button initiates and ends all tests. Note that af ter pressing START the text on the button will change to STOP. D-0123672-H – 2022/05 Page 46 Affinity Compact - Instructions for Use - US...
  • Page 51 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-0123672-H – 2022/05 Page 47 Affinity Compact - Instructions for Use - US...

  • Page 52: Hit440 Software - Technical Specifications

    3.4.1 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 53 Ref erence 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-0123672-H – 2022/05 Page 49 Affinity Compact - Instructions for Use - US...

  • Page 54: Using The Print Wizard

    Press the New Template button to open a new empty template. 6. Select one of the existing templates and press the Edit Template button to modif y the selected layout. D-0123672-H – 2022/05 Page 50 Affinity Compact - Instructions for Use - US...
  • Page 55 For more inf ormation related to the Print reports and Print Wizard, please ref er to the Af f inity Compact Additional Inf ormation document or the Print Report Quick Guide on www.interacoustics.com D-0123672-H – 2022/05 Page 51 Affinity Compact - Instructions for Use - US...
  • Page 56 D-0123672-H – 2022/05 Page 52 Affinity Compact - Instructions for Use - US...

  • Page 57: 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 to guaranty proper service and repair as Interacoustics provides the necessary circuit diagrams etc. to these technicians. •...

  • Page 58: Concerning Repair

    4.3 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 59: Replacement Of Consumables

    . 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. They are connected to the thin tube on the top of the IMH60/65 headset as shown on the image below.

  • Page 60: 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-0123672-H – 2022/05...

  • Page 61: General Technical Specifications

    5.1 Affinity Compact 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.
  • Page 62 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-0123672-H – 2022/05 Page 58 Affinity Compact - Instructions for Use - US...

  • Page 63: 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-0123672-H – 2022/05 Page 59 Affinity Compact - Instructions for Use - US...
  • Page 64 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-0123672-H – 2022/05 Page 60 Affinity Compact - Instructions for Use - US...
  • Page 65 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-0123672-H – 2022/05 Page 61 Affinity Compact - Instructions for Use - US...
  • Page 66 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-0123672-H – 2022/05 Page 62 Affinity Compact - Instructions for Use - US...
  • Page 67 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-0123672-H – 2022/05 Affinity Compact - Instructions for Use - US 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-0123672-H – 2022/05 Page 64 Affinity Compact - Instructions for Use - US...
  • 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-0123672-H – 2022/05 Affinity Compact - Instructions for Use - US 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-0123672-H – 2022/05 Affinity Compact - Instructions for Use - US 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-0123672-H – 2022/05 Affinity Compact - Instructions for Use - US Page 67...
  • Page 72 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-0123672-H – 2022/05 Affinity Compact - Instructions for Use - US Page 68...
  • Page 73 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-0123672-H – 2022/05 Page 69 Affinity Compact - Instructions for Use - US...
  • Page 74 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-0123672-H – 2022/05 Page 70 Affinity Compact - Instructions for Use - US...
  • Page 75 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-0123672-H – 2022/05 Page 71 Affinity Compact - Instructions for Use - US...

  • Page 76: Pin Assignments

    D sub HD 26 poles Ground I²C int Tube 2 lef t mic Ground Tube 1 lef t mic Tube 2 right mic Ground Tube 1 right mic D-0123672-H – 2022/05 Page 72 Affinity Compact - Instructions for Use - US...
  • Page 77 I²C clk Ground Not used Insitu lef t spkr Ground Ground DC bias Ref lef t mic D-0123672-H – 2022/05 Page 73 Affinity Compact - Instructions for Use - US...

  • Page 78: Electromagnetic Compatibility (Emc)

    Insitu Headsets Monitor Headsets w. microphone Monitor Headsets High End Microphones Electret Microphones ½” Coupler Microphones 0.17 Ref Microphones 0.07 Patient response switch’s Loudspeakers USB cables (PC) D-0123672-H – 2022/05 Page 74 Affinity Compact - Instructions for Use - US...
  • Page 79 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 80 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The AFFINITY COMPACT is intended f or use in the electromagnetic environment specif ied below. The customer or the user of the AFFINITY COMPACT should assure that it is used in such an environment. Immunity Test...
  • Page 81 Guidance and manufacturer’s declaration — electromagnetic immunity The AFFINITY COMPACT is intended f or use in the electromagnetic environment specif ied below. The customer or the user of the AFFINITY COMPACT should assure that it is used in such an environment, Immunity test...
  • Page 82 D-0123672-H – 2022/05 Page 78 Affinity Compact - Instructions for Use - US...
  • Page 83 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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