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Interacoustics Callisto AC440, Instructions For Use Manual

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Interacoustics Callisto AC440 Instructions For Use Manual Download Page 5

 

 

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

 

Page 

1

 

 

 

1

 

Introduction 

1.1  About this manual 

This manual is valid for the Affinity Compact. This product is manufactured by: 

 

Interacoustics A/S

 

Audiometer Allé 1 

5500 Middelfart 

Denmark 

Tel.:       

+45 6371 3555 

Fax: 

+45 6371 3522 

E-mail: 

 [email protected] 

Web: 

www.interacoustics.com

 

 

 

1.2  Intended use 

The Affinity Compact

 

with AC440 is intended to be used for the detection and diagnosis of suspected hearing 

loss. 

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.  

The Affinity Compact 

 

with REM440 is intended to be used for Real-Ear Measurement that takes care of all 

clinical verification needs.  

 

Intended operator 

Trained operators like audiologist, hearing healthcare professional, or trained technician. 

 

 

1.3  Product description 

The Affinity Compact is a Hearing Aid Analyzer that interfaces with integrated audiologic software modules 

on a PC. Depending on the installed software modules it can perform:  

•

  Audiometry (AC440) 

•

  Real Ear Measurements (REM440) including Visible Speech Mapping 

•

  Hearing Instrument Testing (HIT440) 

Summary of Contents for Callisto AC440

Page 1: ...Instructions for Use EN Affinity Compact Science made smarter D 0123234 D 2020 05 ...

Page 2: ......

Page 3: ...tallation Windows 8 1 15 2 6 3 Software installation Windows 10 18 2 7 Driver installation 21 2 8 Using with databases 21 2 8 1 Noah 4 21 2 9 Standalone version 21 2 10 How to configure an alternative data recovery location 21 2 11 License 22 2 12 About Affinity Suite 22 3 OPERATING INSTRUCTIONS 23 3 1 Using the tone screen 24 3 2 Using the speech screen 30 3 2 1 Speech audiometry in graph mode 32...

Page 4: ...CHNICAL SPECIFICATIONS 57 5 1 Affinity Compact Hardware Technical Specifications 57 5 2 Tone reference equivalent threshold values for transducers 59 5 3 Pin assignments 72 5 4 Electromagnetic compatibility EMC 74 ...

Page 5: ...dication 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 The Affinity Compact with REM440 is intended to be used for Real Ear Measurement that takes care of all clinical verification needs Intended operator Trained operators like audiologist hearing ...

Page 6: ...0 pcs SPL60 Transducer kit for RECD measurement including probes and ear tips SP100 loudspeaker Standard USB cable Power supply UE60 240250SPA3 Power cable Mouse pad Optional parts Accessory bracket Desktop bracket Table mount bracket Wall mount bracket Battery adapters BAA675 BAA13 BAA312 BAA10 BAA5 Coupler and microphone kit o microphone o Reference microphone o 2cc coupler o 0 4cc coupler o BTE...

Page 7: ...D 0123234 D 2020 05 Affinity Compact Instructions for Use EN Page 3 ...

Page 8: ...The WARNING label identifies conditions or practices that may present danger to the patient and or user The CAUTION label identifies conditions or practices that could result in damage to the equipment NOTICE 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 WARNING CAUTION ...

Page 9: ...ocal distributor Reporting Imperfections Inspect before connection Prior to connecting the product it should once more be inspected for damage All of the cabinet and the accessories should be checked visually for imperfections and missing parts Immediately report any faults Any missing part or malfunction should be reported immediately to the supplier of the instrument together with the invoice se...

Page 10: ...ollection 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 0123 has approved the quality system Year of manufacture Manufacturer Serial number Reference number Indicates a component is intended for one use or for use on a single patient during a single procedure ...

Page 11: ...the requirements If in doubt contact qualified medical technician or your local representative If the instrument is connected to a PC IT equipment forming a system ensure not to touch the patient while operating the PC A Separation Device isolation device is needed to isolate the equipment located outside the patient environment from the equipment located inside the patient environment In particul...

Page 12: ...ding EMC 2 3 5 Cautions General If the system is not functioning properly do not operate it until all necessary repairs are made and the unit is tested and calibrated for proper functioning in accordance with Interacoustics specifications Do not drop or in any other way cause undue impact to this device If the instrument is damaged return it to the manufacturer for repair and or calibration Do not...

Page 13: ...atient s home country shall be informed Interacoustics has a vigilance system to help with this 2 3 6 Environmental factors Storage outside temperature range as specified in Section 2 1 may cause permanent damage to the instrument and its accessories Do not use the device in the presence of fluid that can come into contact with any of the electronic components or wiring Should the user suspect flu...

Page 14: ...lected separately Such products will be marked with the crossed out wheeled bin symbol shown below The cooperation of the user is important in order to ensure a high level of reuse and recycling of electric and electronic waste Failing to recycle such waste products in an appropriate way may endanger the environment and consequently the health of human beings Outside the European Union local regul...

Page 15: ...Microphone 8 AUX Socket for line in from External Sound Source 9 Talk B Socket for Talk back Microphone 10 AC Headset Left Socket for Left AC Phone or HF Phone 11 AC Headset Right Socket for Right AC Phone or HF Phone 12 FF1 Power Socket for power out to FF loudspeaker 13 FF2 Power Socket for power out to FF loudspeaker 14 FF 1 2 Line Socket for line output to FF loudspeaker 15 Insitu Headset Sock...

Page 16: ...Interacoustics will not make any guarantee to the functionality of the system if any other software is installed with exception of the Interacoustics measurement AC440 REM440 modules and AuditBase system4 Otoaccess or Noah4 compatible Office Systems or later releases What you will need 1 Affinity Compact Suite Installation USB Drive 2 USB Cable 3 Affinity Compact Hardware Supported Noah Office Sys...

Page 17: ...art 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 1 Wait for the dialog shown below to appear please specify which hardware you wish to install the software for You must also accept the license terms and conditions ahead of installing On checking the box to accept this the...

Page 18: ...EN Page 14 Should you wish to install the software to a different location than the default then please click on 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 ...

Page 19: ...e 15 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 ...

Page 20: ...en 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 file to initiate the installation 1 Wait for the dialog shown below to appear please specify which hardware you wish to install the software for You must also accept the license terms and conditions ahead of installing On checking the box to accept ...

Page 21: ...EN Page 17 Should you wish to install the software to a different location than the default then please click on 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 ...

Page 22: ... Page 18 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 ...

Page 23: ...en 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 file to initiate the installation 1 Wait for the dialog shown below to appear please specify which hardware you wish to install the software for You must also accept the license terms and conditions ahead of installing On checking the box to accept ...

Page 24: ...EN Page 20 Should you wish to install the software to a different location than the default then please click on 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 ...

Page 25: ... Page 21 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 ...

Page 26: ...ructions about working with OtoAccess please see the OtoAccess operation manual 2 9 Standalone version If you do not have Noah on your computer you can directly launch the software suite as a stand alone module However you will not be able to save your recordings when using this way of working 2 10 How to configure an alternative data recovery location The Affinity CompactAffinity Compact Suite ha...

Page 27: ...ordered software modules If you would like to add additional modules please contact your dealer 2 12 About Affinity Suite Should you go to Menu Help About then you will see the below window This is the area of the software where you can manage license keys and check your Suite Firmware and Build Versions Also in this window you will find the Checksum section which is a feature designed to help you...

Page 28: ...re levels will be invalid and the instrument needs recalibration 4 It is recommended that the disposable foam eartips supplied with the optional IP30 E A R Tone 3A or E A R Tone 5A insert transducers are replaced after each client tested Disposable foam eartips also ensure that sanitary conditions exist for each of your clients and that periodic cleaning of a headband or cushion is no longer requi...

Page 29: ... in Noah or OtoAccess and exits the Suite Collapse the left side panel Go to Tone Audiometry activates the tone screen when in another test Go to Speech Audiometry activates the speech screen when in another test Extended Range 20 dB extends the testing range and can be activated when the testing dial setting gets within 55 dB of the maximum level of the transducer Note that the extended range but...

Page 30: ...anges and returning to the main screen the name of the protocol will be followed by an asterisk List of historical sessions accesses historical sessions for comparison purposes The audiogram of the selected session indicated by the orange background is shown in colours as defined by the used symbol set All other audiograms that are selected by check marks show on screen in the colours as indicated...

Page 31: ...ease refer to the Affinity Compact Additional Information or the Masking Help Quick Guide documents Toggle Automasking will activate or deactivate the Automasking feature For more information on Automasking please refer to the Affinity Compact Additional Information or the Masking Help Quick Guide documents Talk Forward activates the Talk Forward microphone The arrow keys can be used to set the ta...

Page 32: ... the unmasked right and left symbols of the currently selected symbol set Each type of measurement is saved as a separate curve In the Comments section you can type comments related to any audiometric test The used space by the comments area can be set by dragging the double line with your mouse Pressing the Report editor 1 button opens a separate window for adding notes to the current session The...

Page 33: ...HL Increase and Decrease buttons allows for increasing and decreasing the intensities of channel 1 and 2 The arrow keys on the PC keyboard can be used for in decreasing channel 1 intensities PgUp and PgDn on the PC keyboard can be used for in decreasing channel 2 intensities Stimuli or attenuator buttons will light up when the mouse goes over and indicates the active presentation of a stimulus A r...

Page 34: ...cates whether the hardware is connected Simulation mode is indicated when operating the software without hardware When opening the Suite the system will search for the hardware If it does not detect the hardware then the system will automatically continue in simulation mode and the Simulation icon left will show in place of the connected hardware indication picture The Examiner indicates the curre...

Page 35: ...ifferent speech list setups as defined by the selected protocol The labels of these lists which go along with these buttons can also be customized in the protocol setup Selecting HL MCL and UCLsets the symbol types that are currently in use by the audiogram HL stands for hearing level MCL stands for most comfortable level and UCL stands for uncomfortable level Each type of measurement is saved as ...

Page 36: ...mouse click on this button will store the word as correctly repeated You can also click on the Left arrow key to store as correct b Incorrect A mouse click on this button will store the word as incorrectly repeated You can also click on the Right arrow key to store as incorrect c Store A mouse click on this button will store the speech threshold in the speech graph A point can also be stored by pr...

Page 37: ...x axis shows the intensity of the speech signal and the y axis shows the score in percent The score is also displayed in the black display in the upper part of the screen along with a word counter 2 The norm curves illustrate norm values for S Single syllabic and M Multi syllabic speech material respectively The curves can be edited according to individual preferences in the AC440 setup 3 The shad...

Page 38: ...the corresponding label will be orange The SRT table The SRT table Speech Reception Threshold table allows for measuring multiple SRTs using different test parameters e g Transducer Test Type Intensity Masking and Aided 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 t...

Page 39: ...ck on either SRT or WR to choose the test to be conducted binaurally 2 Ensure that the transducers are set up for binaural testing For example insert Right in channel 1 and insert Left in channel 2 3 Click on 4 Proceed with the test when stored results will be stored as binaural results To perform an aided test 1 Select the desired transducer Typically aided testing is done in the Free Field Howev...

Page 40: ...n 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 right hand of the screen 1 Export all shortcuts Use this function to save custom shortcuts and transfer them to another computer 2 Import shortcuts Use this function to import shortcuts that have already been exported from an...

Page 41: ...389 5 2006 ANSI S3 6 2018 Effective masking ISO 389 4 1994 ANSI S3 6 2018 Patient response switch Handheld push button Patient communication Talk Forward and Talk Back Monitor Output through external earphone or speaker Stimuli Pure tone Warble tone NB SN WN TEN noise PED noise Wave files Tone 125 20000Hz separated in two ranges 125 8000Hz and 8000 20000Hz Resolution 1 2 1 24 octave Warble tone 1 ...

Page 42: ... 3dB Rectifier characteristics RMS Selectable inputs are provided with an attenuator by which the level can be adjusted to the indicator reference position 0dB 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 ...

Page 43: ...ear Right click on the ear icon to view both ears NOTE Binaural REM measurements can be performed when both ears are viewed in both REIG measures and REAR The binaural feature enables the fitter to view the binaural right and left measurements simultaneously Toggle between Single and Combined Screen button toggles between viewing one or multiple measurements in the same REM graph Toggle between Si...

Page 44: ...eport Editor button opens a separate window for adding notes to the current session Note that after saving the session no changes can added to the report 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 fi...

Page 45: ...e hearing aid fitting screen allowing for easy curve comparison To return to the original REM440 press the red cross in the upper right hand corner Tube calibration button activates the tube calibration Before measuring it is recommended to calibrate the probe tube This is done by pressing the calibration button Follow the instructions appearing on the screen see screen below and press OK The cali...

Page 46: ... 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 This may be helpful for counselling purposes since the reversed view look more similar to the audiogram and may therefore be easier for the client to comprehend when explaining his her results Insert Edit T...

Page 47: ...commended 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 Current Protocol is listed in the lower left hand corner Upon performing a test the system automatically jumps to the next one in the test flow The checkmarks indicates that a curve has been measured Test protocols can be created and adjusted in ...

Page 48: ... fitting prescription settings such as Age and Client type will differ depending on what fitting prescription is selected 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 c...

Page 49: ... whether the hardware is connected When opening the Suite the system will automatically search for the hardware If it does not detect the hardware then the system will automatically continue in simulation mode and the Simulation icon above right will show in place of the connected hardware indication picture above left ...

Page 50: ...ear 100Hz 12 5kHz Coupler 100Hz 16kHz Frequency accuracy 1 Distortion Internal speaker 200Hz 250Hz 3 70dB 250Hz 400Hz 3 75dB 400Hz 16000Hz 3 90dB SP100 100Hz 200Hz 3 75dB 200Hz 16000Hz 3 90dB Stimuli intensity range 40 100 dB Intensity accuracy 100Hz 200Hz 3 dB 200Hz 8000Hz 1 5 dB 8000Hz 16000Hz 5 dB Measurement intensity range Probe microphone 40 140 dB SPL 2 dB Reference microphone 40 100 dB 2 d...

Page 51: ...o toggle between right and left ear Right click on the ear icon to view both ears Toggle between single and combined screen button toggles between viewing one or multiple measurements in the same HIT graph Toggle between single and continuous measurement button toggles between running a single sweep or having a test signal running continuously until pressing STOP Freeze curve allows for taking a s...

Page 52: ...een for comparison to other sessions Go to Current Session button brings you back to current session Report Editor button opens a separate window for adding notes to the current session Note that after saving the session no changes can added to the report Single frequency button represents an optional manual test that allows for presetting hearing aid gain prior to HIT Place the hearing aid in the...

Page 53: ...or 1 Connect a monitor headset to the monitor output on the hardware 2 Tick the Monitor check box 3 Use the slider to turn the sound level up and down Current Protocol is listed in the lower left hand corner The indicates the test is a part of an automatic test flow Auto Run When pressing START all tests with the tick mark will be performed If you wish to perform one test only mark it using the mo...

Page 54: ...ensuring that the curve is always visible in the middle of the screen Measurement details In this table the curve details can always be viewed This way the professional always has an overview of what is being measured Read information such as Input Level Max SPL Curve Type Stimulus and Curve type A Curve Comment for each curve can be typed into the comment section on the right hand side Select a c...

Page 55: ...speech IFFM IF Noise SS SH Custom sound files automatic calibration available Sweep speed 4 22 sec FFT Resolution 1024 points Averaging 1sec 1200sec Stimulati intensity range 40 100 dB SPL in 1 dB step Intensity accuracy 100Hz 200Hz 3 dB 200Hz 8000Hz 1 5 dB 8000Hz 16000Hz 5 dB Measurement intensity range 100Hz 200Hz 40 145 dB SPL 3 dB 200Hz 8000Hz 40 145 dB SPL 1 5 dB 8000Hz 16000Hz 40 145 dB SPL ...

Page 56: ...Full On Gain Input output Attack Recovery Time Reference Test Gain Frequency Response Equivalent Input Noise Harmonic Distortion Intermodulation Distortion Battery Current Drain Microphone Directionality Coil Frequency Response Coil Harmonic Distortion Coil Full On Gain Response Compatible software Noah 4 OtoAccess and XML compatible ...

Page 57: ...rd templates User defined to show only custom templates Hidden to show hidden templates My favorites to show only templates marked as a favorite 2 Available templates from the selected category are shown in the Templates viewing area 3 Factory default templates are recognized by the lock icon They ensure that you always have a standard template and do not need to create a customized one However in...

Page 58: ... is selected under Categories To remove a template marked with a star from My Favorites select the template and press the My Favorites button 10 Select one of the templates and press the Preview button to print preview the template on screen 11 Depending how you reached the Print Wizard you will have the option to press a Print for using the selected template for printing or press b Select for ded...

Page 59: ...D 0123234 D 2020 05 Affinity Compact Instructions for Use EN Page 55 ...

Page 60: ...exercised when handling earphones and other transducers as mechanical shock may cause a change in calibration 4 2 How to clean Interacoustics products If the surface of the instrument or accessories can be cleaned using a soft cloth moistened with a mild solution of water and dish washing detergent or similar The use of organic solvents and aromatic oils must be avoided Always disconnect the USB c...

Page 61: ...ir facility Repair or replacement will be carried out at Interacoustics expense subject to the terms of this warranty The product requiring service should be returned promptly properly packed and postage prepaid Loss or damage in return shipment to Interacoustics shall be at purchaser s risk In no event shall Interacoustics be liable for any incidental indirect or consequential damages in connecti...

Page 62: ... and 64 bit Windows 8 64 bit Windows 10 64 bit Compatible software Noah 4 OtoAccess and XML compatible Input specifications Talk Back 240µVrms at max input gain for 0dB VU reading Input impedance 47 5KΩ Mic Talk Forward 240µVrms at max input gain for 0dB VU reading Input impedance 47 5KΩ Patient respond Switches 3 3V to the logic input The switch current is 1 5mA AUX 10mVrms at max input gain for ...

Page 63: ...z 20kHz 3dB Data connections USB PC USB B socket for connection to PC compatible with USB 2 0 and later Internal test box Built in test box holds connections to reference microphone coupler microphone battery pill and tele coil Dimensions LxWxH Affinity Compact version 1 3 Affinity Compact version 4 22 6 x 22 6 x 6 cm 8 9 x 8 9 x 2 4 inches 24 4 x 22 6 x 13 5 cm 9 6 x 8 9 x 5 3 inches Weight Affin...

Page 64: ... 5 41 5 Tone 3000 Hz 8 10 2 2 5 3 3 5 3 5 30 42 30 42 Tone 3150 Hz 8 10 3 4 2 5 4 4 31 42 5 31 42 5 Tone 4000 Hz 9 9 5 9 5 9 5 0 5 5 5 5 5 35 5 43 5 35 5 43 5 Tone 5000 Hz 13 13 15 5 14 10 5 5 5 40 51 40 51 Tone 6000 Hz 20 5 15 5 21 17 21 2 2 40 51 40 51 Tone 6300 Hz 19 15 21 17 5 21 5 2 2 40 50 40 50 Tone 8000 Hz 12 13 21 17 5 23 0 0 40 50 40 50 Tone 9000 Hz 19 27 5 Tone 10000 Hz 22 18 Tone 11200...

Page 65: ... 115 70 55 75 60 Tone 750 Hz 120 120 115 120 120 115 115 70 55 75 60 Tone 800 Hz 120 120 115 120 120 115 115 70 55 75 60 Tone 1000 Hz 120 120 115 120 120 120 120 70 60 85 75 Tone 1250 Hz 120 120 115 110 120 120 120 70 60 90 80 Tone 1500 Hz 120 120 115 115 120 120 120 70 55 90 80 Tone 1600 Hz 120 120 115 115 120 120 120 70 55 90 75 Tone 2000 Hz 120 120 115 115 120 120 120 75 60 90 75 Tone 2500 Hz 1...

Page 66: ... 12 10 11 9 6 5 6 5 52 64 52 64 NB 1000 Hz 12 13 10 5 11 5 8 6 6 48 5 57 48 5 57 NB 1250 Hz 13 12 5 9 5 12 8 5 8 8 45 55 45 55 NB 1500 Hz 14 12 5 8 5 11 5 9 8 8 42 5 53 5 42 5 53 5 NB 1600 Hz 14 13 8 5 11 5 8 5 8 8 41 5 52 5 41 5 52 5 NB 2000 Hz 14 15 8 5 10 5 6 9 9 37 48 5 37 48 5 NB 2500 Hz 14 15 5 8 9 4 11 11 35 5 47 5 35 5 47 5 NB 3000 Hz 14 16 8 8 5 3 9 5 9 5 36 48 36 48 NB 3150 Hz 14 16 9 10...

Page 67: ...0 110 105 100 100 110 110 60 45 65 50 NB 800 Hz 110 110 105 100 105 110 110 60 45 65 50 NB 1000 Hz 110 110 105 100 105 110 110 60 50 70 60 NB 1250 Hz 110 110 105 95 105 110 110 60 50 75 60 NB 1500 Hz 110 110 105 100 105 110 110 60 45 75 60 NB 1600 Hz 110 110 105 100 105 110 110 60 45 75 60 NB 2000 Hz 110 110 105 100 105 110 110 65 50 70 55 NB 2500 Hz 110 110 105 100 110 110 110 65 50 65 50 NB 3000...

Page 68: ...AR 2ccm 2ccm MASTO ID FOREHE AD MASTO ID FOREHEA D Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Max HL Speech 110 110 100 90 100 Speech Equ FF 100 105 95 85 95 Speech Non linear 120 120 110 110 120 110 110 60 40 60 50 Speech noise 100 100 95 85 95 Speech noise Equ FF 100 100 90 80 95 Speech noise Non linear 115 115 105 105 120 110 110 50 40 50 40 White noise in speech 95 9...

Page 69: ...D450 GF GC ANSI S3 6 2018 and ISO 389 8 2004 HDA300 GF GC PTB report 2013 IEC Speech level IEC60645 2 1997 acoustical linear weighting IEC Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting IEC Speech Not linear level 1 kHz RETSPL DD45 TDH39 DD65V2 DD450 HDA300 and EAR3A IP30 B7 and B81 IEC60645 2 1997 no weighting IEC SPEECH MAX HL TRANSDUCER...

Page 70: ... S3 6 2018 and ISO 389 8 2004 HDA300 GF GC PTB report 2013 Sweden Speech level STAF 1996 and IEC60645 2 1997 acoustical linear weighting Sweden Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting Sweden Speech Not linear level 1 kHz RETSPL DD45 TDH39 DD65V2 DD450 HDA300 and EAR 3A IP30 B71 and B81 STAF 1996 and IEC60645 2 1997 no weighting SWED...

Page 71: ...GC ANSI S3 6 2018 and ISO 389 8 2004 HDA300 GF GC PTB report 2013 Norway Speech level IEC60645 2 1997 20dB acoustical linear weighting Norway Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting Norway Speech Not linear level 1 kHz RETSPL DD45 TDH39 DD65V2 DD450 HDA300 and EAR 3A IP30 B71 and B81 IEC60645 2 1997 20dB no weighting NORWAY SPEECH M...

Page 72: ...F GC ANSI S3 6 2018 and ISO 389 8 2004 HDA300 GF GC PTB report 2013 Japan Speech level JIS T1201 2 2000 acoustical linear weighting Japan Speech Equivalent free field level GF GC from IEC60645 2 1997 acoustical equivalent sensitivity weighting Japan Speech Not linear level 1 kHz RETSPL DD45 TDH39 DD65V2 DD450 HDA300 and EAR 3A IP30 B71 and B81 IEC60645 2 1997 no weighting JAPAN SPEECH MAX HL TRANS...

Page 73: ...9 2010 TDH39 GF GC IEC60645 2 1997 DD65V2 GF GC PTB AAU report 2018 DD450 GF GC ANSI S3 6 2018 and ISO 389 8 2004 HDA300 GF GC PTB report 2013 SPL SPEECH MAX HL TRANSDUCER DD45 TDH39 DD65 v2 DD450 HDA300 EAR3A IP30 B71 B71 B81 B81 IMPEDANCE 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12 5 Ω 12 5 Ω COUPLER 6ccm 6ccm ARTIFICIAL EAR ARTIFICIAL EAR ARTIFICIAL EAR 2ccm 2ccm MASTOID FOREHEA D MASTOID F...

Page 74: ... 106 5 101 5 91 5 81 5 2000 1 5 4 5 3 5 2 93 5 83 5 103 5 98 5 88 5 78 5 2500 4 7 5 6 2 91 81 101 96 86 76 3000 6 11 8 5 2 94 84 104 94 89 79 3150 6 11 8 2 94 84 104 94 89 79 4000 5 5 9 5 5 2 94 5 84 5 104 5 99 5 89 5 79 5 5000 1 5 7 5 5 5 2 93 5 83 5 108 5 98 5 88 5 78 5 6000 4 5 3 5 2 94 5 84 5 104 5 99 5 89 5 79 5 6300 6 1 5 4 2 96 86 106 96 91 81 8000 12 5 7 4 2 87 5 72 5 92 5 87 5 87 5 77 5 W...

Page 75: ...SPL RETSPL RETSPL MAX SPL MAX SPL MAX SPL Speech 0 4 5 5 2 90 100 80 Speech Noise 0 4 5 5 2 85 100 75 Speech WN 2 5 1 5 3 2 87 5 97 5 82 5 JAPAN FREE FIELD ISO 389 7 2005 FREE FIELD MAX SPL FREE FIELD MAX HL IS FOUND BY SUBTRACTING THE SELECTED RETSPL VALUE BINAURAL BINAURAL TO MONAURAL FREE FIELD POWER FREE FIELD LINE FREE FIELD INTERNAL 0 45 90 CORRECTION 0 45 90 0 45 90 0 45 90 RETSPL RETSPL RE...

Page 76: ...2 0 0 0 1500 1600 4 0 7 0 3 0 5 5 0 5 2000 6 0 7 0 2 5 5 0 2 0 2500 7 0 9 5 2 5 6 0 3 0 3000 5 5 3150 10 5 12 0 9 5 7 0 6 0 4000 10 5 8 0 9 5 13 0 4 5 5000 11 0 8 5 13 0 14 5 10 5 6000 6300 10 5 9 0 9 0 11 0 7 0 8000 1 5 1 5 4 5 8 5 10 0 SOUND ATTENUATION VALUES FOR EARPHONES FREQUENCY ATTENUATION TDH39 DD45 with MX41 AR or PN 51 Cushion EAR 3A IP30 DD65V2 DD450 HDA300 Hz dB dB dB dB dB 125 3 33 8...

Page 77: ...bias Signal Batt Sim Internal TB Vbat Sense Vbat FF1 FF2 line Ground Signal FF1 line Signal FF2 line Monitor Signal monitor Signal monitor Signal monitor Talk forward Ground DC bias Signal AUX Ground AUX 2 AUX 1 TB Ref internal TB Binder Series 719 3 poles DC bias Ground Signal DC bias USB connector USB device 1 5 VDC 2 Data 3 Data 4 Ground D sub HD 26 poles Pin Type Pin Type 1 I C data 14 DC bias...

Page 78: ...D 0123234 D 2020 05 Affinity Compact Instructions for Use EN Page 74 10 I C clk 23 Ground 11 Not used 24 Insitu left spkr 12 Ground 25 Ground 13 DC bias 26 Ref left mic ...

Page 79: ... accessories transducers and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of this instrument including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result NOTICE ESSENTIAL PERFORMANCE for t...

Page 80: ...uipment RF emissions CISPR 11 Class B The AFFINITY COMPACT is suitable for use in all commercial industrial business and residential environments Harmonic emissions IEC 61000 3 2 Complies Class A Category Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Recommended separation distances between portable and mobile RF communications equipment and the AFFINITY COMPACT The AFFINITY COMPAC...

Page 81: ...environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip ...

Page 82: ...recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all sit...

Page 83: ...crophone grey clip on type Interacoustics EM400 Coupler Microphone Interacoustics Ref Microphone Interacoustics 1010 Patient response switch Interacoustics APS3 Loudspeaker Radioear Any USB cable PC Interacoustics type A B Conformance to the EMC requirements as specified in IEC 60601 1 2 is ensured if the cable types and cable lengths are as specified below Description Length m Screened Yes No Aud...

Page 84: ......

Page 85: ... Returned according to agreement with Interacoustics 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 1 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 P...

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