Interacoustics AC40 Instructions For Use Manual
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Interacoustics AC40 Instructions For Use Manual

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Instructions for Use – EN
AC40

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Summary of Contents for Interacoustics AC40

  • Page 1 Science made smarter Instructions for Use – EN AC40...

  • Page 2: Table Of Contents

    3.6.7 Sessions and clients ...........................41 3.6.7.1 Save session ........................41 3.6.7.2 Clients ..........................41 Printing ................................42 AC40 stand alone unit, print logo update ....................42 Diagnostic Suite ..............................44 3.9.1 Instrument setup ..........................44 3.9.2 SYNC mode 45 3.9.3 The sync tab ............................45 3.9.4 Client upload............................45...
  • Page 3 GENERAL TECHNICAL SPECIFICATIONS............52 Survey of reference and max hearing level Tone Audiometer..............56 Maximum hearing level settings provided at each test frequency ............60 AC40 Pin assignment .............................67 Electromagnetic Compatibility (EMC) ......................68...

  • Page 4: Introduction

    Product description The AC40 is a f ull 2 channel clinical audiometer of f ering air, bone, speech and built in f ree f ield amplier. It of f ers a wide range of clinical test f eatures such as high f requency, multi f requency, weber, SISI, etc.
  • Page 5 Talk back microphone Sound f ield speakers SP90 (with external power amp) AP12 Power Amplif ier 2x12 Watt AP70 Power Amplif ier 2x70 Watt Cable USB 2m Diagnostic Suite OtoAccess® database D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 2...

  • Page 6: Warnings

    CAUTION, used with the saf ety alert symbol, indicates a hazardous situation which, if not avoided, could result in damage of the equipment. NOTICE NOTICE is used to address practices not related to personal injury or damage of the equipment. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 3...

  • Page 7: 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 satisf action. Storage If you need to store the AC40 f or a period, please ensure it is stored under the conditions specif ied in the section f or technical specif ications. D-01133688-B – 2024/08...

  • Page 8: Marking

    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.

  • Page 9: General Warnings And Precautions

    No modif ication of this equipment is allowed without Interacoustics authorization. Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other inf ormation that will assist service personnel to repair those parts of this audiometer that are designated by the Interacoustics as repairable by service personnel Never insert or in any way use the insert headset without a new clean non def ect test tip.

  • Page 10: Malfunction

    Interacoustics and the local national competent authority. Disposal of the product Interacoustics is committed to ensuring that our products are saf ely disposed of when they are no longer usable. The cooperation of the user is important to ensure this. Interacoustics theref ore expects that local sorting and waste regulations f or disposal of electric and electronic equipment are f ollowed, and that the device is not discarded together with unsorted waste.

  • Page 11: Getting Started - Setup And Installation

    Talk f orward mic. The top lef t part of the AC40 (display holder) contains the two monitor speakers. The lef t side of the instrument contains two mini jack connectors f or a microphone and a headphone – or a headset.

  • Page 12: Back Panel External Connections - Standard Accessories

    HF Headphone connectors f or HLS. This is prepared f or f uture use. In addition to the standard DD45 headset, other air conduction transducers may be used (they all • connect to specif ic outputs on the AC40): IP30 insert phone is the standard insert phone. •...

  • Page 13: Patient Communication And Monitoring

    This has the f irst priority. • Priority 2: The swan neck microphone (1) of the AC40 is located above the “Talk Forward” (24) button. If no mic. is connected to the priority 1 mic., this with be used.

  • Page 14: Operating Instructions

    Operating instructions The f igure below shows the outline of the f ront plate of the AC40 including buttons, dials, and display: (19) (11) (12) (13) (14) (15) (16) (17) (20) (21) (22) (23) (18) (10) (25) (26) (27) (28)
  • Page 15 A single push will by def ault enter the selected Test Settings menu. To enter other settings menus, hold the “Setup” button and use on of the rotary wheels (57)/(58) to select: D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 12...
  • Page 16 “Aided” is in f ocus: Tests Allows the clinician to access special tests. Hold down the “Tests” button and use one of the rotary wheels (57)/(58) to select the individual tests D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 13...
  • Page 17 Save Session dialogue. Print Allows results to be printed directly af ter testing (via a supported USB printer – please contact Interacoustics customer service f or a Clients list of supported PC printers if in doubt). The printout logo can be conf igured via the Diagnostic Suite (in the General Setup a logo image can be downloaded to the instrument f rom the PC).
  • Page 18 Pure tones or warble tones can be chosen as stimuli on channel 2 Channel 2 by activating this button once or twice. The stimulus chosen will be shown on the display, e.g.: D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 15...
  • Page 19 Talk Back When active it allows the clinician to hear comments or responses f rom the patient through the AC40 or monitor headset. Adjust the gain by holding down the button f or one second and turning one of the rotary wheels (57)/(58) while holding the Talk Back button.
  • Page 20 Down / Incorrect Is used to decrease the f requency level. The AC40 has an incorporated automatic speech score counter. Theref ore, as a second f unction you can use this button as an “Incorrect” button when perf orming speech tests. For automatic speech score counting while testing speech push this button af ter each word not repeated correctly by the patient.
  • Page 21 Name(s)/Function(s) Description The AC40 has an incorporated automatic speech score counter. Theref ore, as a second f unction you can use this button as a “Correct” button when perf orming speech tests. For automatic speech score counting while testing speech push this button af ter each word heard correctly by the patient.

  • Page 22: Tests Screens And Function Key Descriptions

    Tone Screen – i.e. as extensions to the Tone audiogram test screen. Please note that the tests available in this list depend on the test licenses installed on the instrument. This may also vary f rom country to country. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 19...

  • Page 23: Tone Test

    Switch between magnif ied top bar and normal sized top bar. View the masking levels (dual audiogram mode only). Multi f requency (optional MF license) High Frequency (optional HF license) High Frequency Zoom (optional HF license) D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 20...

  • Page 24: Stenger Test

    3.5.4 Tone in noise test (Langenbeck test) Please ref er to the Tone Test section above f or key f unction descriptions f or Function Keys (10), (13), (14), (15), (16), (17). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 21...

  • Page 25: Weber

    It examines the patient’s processing ability in relation to their degree and type of hearing loss which can vary greatly between patients with the same hearing loss conf iguration. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 22...
  • Page 26 If the speech and calibration signal are not the same level, it must be manually corrected. The speech screen set up in table mode using wave f iles (26) - under Setup (19). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 23...
  • Page 27 F-buttons, press play to play the word. When the wordlist is completed or another track has to be selected, use the End F-button to leave the recording mode. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 24...
  • Page 28 Play / Forward / Stop Track Phoneme score 0-4 Pause Reverse D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 25...
  • Page 29 Show traces Select Family to f acilize the user with the method of recording Test high f requencies Single Freq test Start test. Tests all f requencies. Stop test. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 26...
  • Page 30 “Settings” (19) and changing continuous to pulse. Please ref er to the HW Test section above f or key f unction descriptions f or Function Keys (10), (11), (12), (16), (17). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 27...
  • Page 31 Dif f erent lists can be changed in the “List” option. Use the HL dB dial (57) to select the dif f erent items in the lists. Start QuickSIN test D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 28...
  • Page 32 Signal and noise in phase Noise in phase and signal in reversed phase. Signal is in phase and the noise in reversed phase. Start MLD test. Stop MLD test. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 29...
  • Page 33 Only available if High Frequency is available (optional license) on the instrument. Selects the HF phone connected to the separate HF connectors. Amplitude modulation Start SISI test. Stop SISI test. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 30...
  • Page 34 2. Copy the files to a newly FAT32 formatted USB memory stick 3. Insert the stick into one of the USB connections on the AC40. 4. Go to Common Setup and press “Install” 5. Wait f or the installation to complete.
  • Page 35 Start HLS test Stop HLS test The HIS test uses the same wave f iles as the MHA test screen and is installed in the same way. Please see above. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 32...
  • Page 36 Start the test Stop a running test. Only available if High Frequency is available (optional license) on the instrument. Selects the HF phone connected to the separate HF connectors. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 33...

  • Page 37: Setup

    (57). Here an example f rom the Tone settings dialogues where “Aided” is in f ocus: For a detailed description of the setting dialog, please ref er to AC40 Quick Guides f ound here: https://www.interacoustics.com/audiometers/ac40/support D-01133688-B –...

  • Page 38: Instrument Setup

    3.6.1 Instrument setup The screen shot below shows the Instrument Settings menu: 3.6.2 Common settings - AUD The screen shot below shows the common settings menu: D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 35...
  • Page 39 Save user setting (protocol) New audiometric symbol schemes are installed via the Diagnostic Suite under General Setup. The same applies to the clinic logo shown on the direct printout. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 36...

  • Page 40: Tone Setting

    3.6.3 Tone setting The screen shot below shows settings f or Pure Tone testing: Function key Description Show settings f or the speech banana. Go back. Save user setting (protocol) D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 37...

  • Page 41: Speech Settings

    3.6.4 Speech settings The screen shot below shows settings f or Speech testing: Function key Description Phoneme norm curve settings. FF norm curve setting. Go back. Save user setting (protocol). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 38...

  • Page 42: Auto Settings

    3.6.5 Auto settings Function key Description Go back. Save user setting (protocol). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 39...

  • Page 43: Mld Settings

    3.6.6 MLD settings Function keys Description Go back. Save user setting (protocol). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 40...

  • Page 44: Sessions And Clients

    Return to the session. Save session under the selected client. 3.6.7.2 Clients Function keys Description Delete the selected client. Return to the session. Access the sessions saves under the selected client. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 41...

  • Page 45: Printing

    Direct printout: Allows results to be printed directly af ter testing (via a supported USB printer – • please contact Interacoustics customer service f or a list of supported PC printers if in doubt). The printout logo can be conf igured via the audiometer itself (see below) or via the Diagnostic Suite (in the General Setup a logo image can be downloaded to the instrument f rom the PC).
  • Page 46 16. For the question “Do you want to install” press the “Yes” button 17. Af ter installation is completed, press the “Back” button to get to the testing screen D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 43...

  • Page 47: Diagnostic Suite

    AC40 (when viewing the build in audiogram) by using the “Upload Custom Symbols” button. Please ref er to the AC40 operational manual f or inf o on how to change the symbol scheme on the AC40.

  • Page 48: Sync Mode

    3.9.3 The sync tab If there is several sessions stored on the AC40 (under one or more patients) then the Sync tab must be used. The screen shot below shows the Diagnostic Suite with the SYNC tab open (underneath the AUD and IMP tabs in the upper right corner).

  • Page 49: Session Download

    3.9.5 Session download The f ollowing screen shot shows the session download screen: When pressing the icon the f unctionality of the “Session download” screen is described: D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 46...

  • Page 50: About Diagnostic Suite

    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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 47...

  • Page 51: Hybrid (Online/Pc-Controlled) Mode

    The f ollowing screen shots show the Diagnostic Suite AUD tab when running AC40 in “hybrid mode”. This mode allows f or the AC40 to be “on-line” connected to the PC – i.e. a trued hybrid audiometer: Operate the unit via a PC and •...

  • Page 52: Maintenance

    We also required recalibrating of the instrument; if something drastic happens to a part of it (e.g. headset or bone conductor is dropped on a hard surf ace). D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 49...

  • Page 53: How To Clean Interacoustics Products

    • 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 54: Warranty

    Interacoustics warrants that: • The AC40 is f ree f rom def ects in material and workmanship under normal use and service f or a period of 24 months f rom the date of delivery by Interacoustics to the f irst purchaser •...

  • Page 55: General Technical Specifications

    IEC 60601-1-2:2014 Audiometer Standards Tone: IEC 60645-1:2012/ANSI S3.6:2010 Type 1- Speech: IEC 60645-2:1993/ANSI S3.6:2010 Type A or A-E Calibration Calibration inf ormation and instructions are located in the AC40 Service manual TDH39: ISO 389-1 1998, ANSI S3.6-2010 Conduction DD45: PTB/DTU report 2009 DD65 v2 PTB 1.61-4091606 2018...
  • Page 56 (IEC 60318-3 250-4000 +1/-1 +1/-1 +2/-2 +2/-3 Coupler) 4000-6300 +0/-2 +0/-2 +1/-1 +1/-1 125-250 +0/-2 +1/-0 +0/- +0/-7 DD65 v2 250-4000 +1/-1 +1/-1 +2/-2 +2/-3 4000-6300 +0/-2 +0/-2 +1/-1 +1/-1 D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 53...
  • Page 57 Input impedance : 3.2KOhm TF (f ront panel) 212uVrms at max. gain f or 0dB reading Input impedance : 3.2KOhm Wave f iles Plays wave f ile f rom internal SD card D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 54...
  • Page 58 Temperature: 15-35°C Re. Humidity: 30-90% Non-condensing Ambient pressure: 98-104 kPa Transport and storage Transport temperature: -20-50°C Storage temperature: 0-50°C Re. Humidity: 10-95% Non-condensing Warm up time Approx. 1 minute D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 55...

  • Page 59: Survey Of Reference And Max Hearing Level Tone Audiometer

    DD65 v2 Artificial ear uses IEC60318-1 coupler with type 1 adapter and RETSPL comes from ANSI S3.6 2018. Force 10 ±0.5N B71 / B81 uses ANSI S3.13 or IEC60318-6 2007 mechanical coupler and RETFL come from ANSI S3.6 2010 and ISO 389-3 1994. Force 5.4N ±0.5N D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 56...
  • Page 60 Tone 6300 Hz 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 57...
  • Page 61 NB 20000 Hz 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 2010 or ISO389-4 1994. D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 58...
  • Page 62 NB 8000 Hz 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 59...

  • Page 63: Maximum Hearing Level Settings Provided At Each Test Frequency

    Max HL 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 60...
  • Page 64 Max HL 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 61...
  • Page 65 Max HL 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 62...
  • Page 66 Max HL 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-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 63...
  • Page 67 0° - 45° - 90° 0° - 45° - 90° Max SPL Max SPL RETSPL RETSPL RETSPL RETSPL Speech -5.5 Speech Noise -5.5 Speech WN -1.5 87.5 97.5 D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 64...
  • Page 68 -1,0 -3.5 1500 1600 -4,0 -7.0 2000 -6,0 -7.0 2500 -7,0 -9.5 3000 3150 -10,5 -12.0 4000 -10,5 -8.0 5000 -11,0 -8.5 6000 6300 -10,5 -9.0 8000 +1,5 -1.5 D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 65...
  • Page 69 Frequency Attenuation TDH39/DD45 with MX41/AR IP30 or PN 51 Cushion [Hz] [dB]* [dB]* 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 *ISO 8253-1 2010 D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 66...

  • Page 70: Ac40 Pin Assignment

    CTRL 3.5mm Stereo Ground CTRL Signal FF1 & FF2 Ground Signal FF3 & FF4 Black FF1 & FF2 Loudspeaker Signal Loudspeaker Signal FF3 & FF4 Negative Positive Terminal Block D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 67...

  • Page 71: Electromagnetic Compatibility (Emc)

    Description Length (m) Screened (Yes/No) Audiometric Headset Audiometric Insert-Headset Bone conductor Monitor Headset w. microphone Monitor Headset Patient response switch Loudspeaker USB cable (PC) D-01133688-B – 2024/08 Instructions for Use AC40 - EN Page 68...
  • Page 72 EMC information presented in this chapter. The AC40 has been tested for EMC emissions and immunity as a standalone AC40. Do not use the AC40 adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
  • Page 73 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The AC40 is intended for use in the electromagnetic environment specified below. The customer or the user of the AC40 should assure that it is used in such an environment. Immunity Test IEC 60601 Test level...
  • Page 74 Guidance and manufacturer’s declaration — electromagnetic immunity The AC40 is intended for use in the electromagnetic environment specified below. The customer or the user of the AC40 should assure that it is used in such an environment, Immunity test IEC / EN 60601 test level Compliance level Electromagnetic environment –...

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