Interacoustics AD629 Instructions For Use Manual
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Interacoustics AD629 Instructions For Use Manual

Device for diagnosing hearing loss
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Science made smarter
Instructions for Use – EN
AD629

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  • Page 1 Science made smarter Instructions for Use – EN AD629...

  • Page 2: Table Of Contents

    Sessions and clients ....................31 Save session ....................32 Clients ......................32 Printing ..........................33 AD629 stand alone unit, print logo update ................ 33 Diagnostic Suite ........................ 35 AD629 setup ......................35 SYNC mode ......................36 The SYNC tab ......................36 Client upload ......................
  • Page 3 GENERAL TECHNICAL SPECIFICATIONS ................44 AD629 technical specification ................... 44 Survey of reference and max hearing level tone audiometer........... 48 AD629 pin assignments ....................59 Electromagnetic compatibility (EMC) ................60...

  • Page 4: Introduction

    1.2 Intended use The AD629 audiometer is designed to be a device for diagnosing hearing loss. Output and specificity of this type of device are based on the test characteristics defined by the user and may vary depending on environmental and operating conditions.

  • Page 5: Product Description

    1.3 Product description The AD629 is a 2 channel clinical audiometer offering air, bone, speech and free field line output. It offers a wide range of clinical test features such as high frequency, SISI, etc. Included parts DD45 Audiometric headset...

  • Page 6: Unpacking And Installation

    Your local distributor holds the responsibility for coordinating any service/return procedure and related formalities. Storage If you need to store the AD629 for a period, please ensure it is stored under the conditions specified in the section for technical specifications: D-0133833-A – 2022/09...

  • Page 7: Markings

    2.2 Markings The following marking can be found on the AD629: Symbol Explanation Type B applied parts Follow instructions for use WEEE (EU-directive) This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling.

  • Page 8: General Warnings And Precautions

    Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative. If the AD629 is connected to a PC (IT equipment forming a system) ensure not to touch the patient while operating the PC.
  • Page 9 The insert transducer should be examined prior to attaching a new foam tip • The AD629 is not intended to be used in oxygen rich environments or use in conjunction with flammable agents. Although the AD629 fulfills the relevant EMC requirements, precautions should CAUTION be taken to avoid unnecessary exposure to electromagnetic fields, e.g., from...

  • Page 10: Getting Started - Setup And Installation

    The top left part of the AD629 (display holder) contains monitor speaker. The left side of the AD629 contains two mini jack connectors for a microphone and a headphone – or a headset. This is used for talkback headphone/speaker (TB) and talk forward microphone (TF).

  • Page 11: Back Panel External Connections - Standard Accessories

    Special notes: In addition to the standard DD45 headset, four other air conduction transducers may be used • (they all connect to specific outputs on the AD629): • HDA300: High Frequency requires a HF headset • EAR-Tone 3A or 5A general purpose insert phone: Insert headphone EAR-Tone 3A or 5A are high quality transducers that may be used instead of the DD45/TDH39.

  • Page 12: Patient Communication And Monitoring

    (depending on which one(s) is connected): • Priority 1: The mini jack in the left side of the AD629 – can be used with a headset together with the headphone connector. This has the first priority Priority 2: The swan neck microphone (1) of the AD629 is located above the “Talk Forward”...

  • Page 13: Operating Instructions

    3.4 Operating instructions The figure below shows the outline of the front plate of the AD629 including buttons, dials, and display: (9 (10) (11) (12) (13) (14 (15) (16) (17) (18) (19) (20) (22) (23) (24) (25) (26) (27) (28)
  • Page 14 Wavefile Enables one to perform speech testing using loaded wave files, i.e. pre-recorded speech material. Please see setup under Temp Setup (15). Requires installation of speech material. D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 11...
  • Page 15 Ch 1 Monitor 2 With the activation of this button, presentation to the patient from e.g., CD can be heard through the built in monitor of the AD629 or monitor headset in both channel 1 and 2. Adjust the gain by holding down the button for one second.
  • Page 16 Use this function if the patient has shown no response to stimuli. Down / Incorrect Used to decrease the frequency level. The AD629 has an incorporated automatic speech score counter. Therefore, as a second function you can use this button as an “Incorrect” button when performing speech tests. For automatic speech score counting while testing speech push this button after each word not heard correctly by the patient.

  • Page 17: Tests Screens And Function Key Descriptions

    The (optional) HF (High Frequency) / HFz (High Frequency Zoom) test features are activated from the 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 AD629. This may also vary from country to country.

  • Page 18: Tone Test

    Function key Description Only available if High Frequency is available (optional license) on the AD629. Selects the HF phone connected to the separate HF connectors. Choose between HL, MCL and UCL by holding the Function Key (8) and select the required measuring type by using one of the rotary wheels (41)/(43).

  • Page 19: Ablb - Fowler Test

    Tone in noise test (Langenbeck test) Please refer to the Tone Test section above for key function descriptions for Function Keys (7), (8), (10), (11), (12), (13), (14). D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 16...

  • Page 20: Weber

    WR (Word Recognition). WR is sometimes also referred to as SDS (Speech Discrimination Scores) and represents the number of words correctly repeated expressed as a percentage. D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 17...
  • Page 21 The speech screen set up in table mode using wave files (23) - under Setup (16). Function key Description Only available if High Frequency is available (optional license) on the AD629. Selects the HF phone connected to the separate HF connectors. Choose between HL, MCL and UCL by holding the Function Key (8) and select the required measuring type by using one of the rotary wheels (41)/(43).
  • Page 22 When the wordlist is completed or another track has to be selected, use the End F-button to leave the recording mode. Play / Forward / Stop Track Phoneme score 0-4 Pause Reverse D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 19...

  • Page 23: Speech - Ch2On

    3 (or 3 out of 5) correct responses at a certain level in a 5dB increase and a 10dB decrease test procedure. Function key Description Show traces Select other 20y. Test high frequencies. Single Freq test. Start test. Tests all frequencies. Stop test. D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 20...
  • Page 24 “Settings” (16) and changing continuous to pulse. Please refer to the HW Test section above for key function descriptions for Function Keys (8), (9), (10), (13), (14). D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 21...
  • Page 25 Function key Description Only available if High Frequency is available (optional license) on the AD629. Selects the HF phone connected to the separate HF connectors. Different lists can be changed in the “List” option. Use the HL dB dial (41) to select the different items in the lists.
  • Page 26 1 dB, as where a patient with a retro cochlear disorder will not. Function key Description Only available if High Frequency is available (optional license) on the AD629. Selects the HF phone connected to the separate HF connectors. Amplitude Modulation.
  • Page 27 2. Copy the files to a newly FAT32 formatted USB memory stick 3. Insert the stick into one of the USB connections on the AD629 4. Go to Common Setup and press “Install” 5. Wait for the installation to complete 6.
  • Page 28 Function key Description Only available if High Frequency is available (optional license) on the AD629. Selects the HF phone connected to the separate HF connectors. Right channel on. Left channel on.

  • Page 29: Setup

    Allows the clinician to make changes in certain settings within each test and to change the common settings for the AD629. A single push will by default enter the selected Test Settings menu. To enter other settings menus, hold the “Setup” button and use on of the rotary wheels (41)/(43) to select: To save the settings use “Save all settings as...”.

  • Page 30: Ad629 Setup

    AD629 setup The screen shot below shows the AD629 settings menu: Common settings The screen shot below shows the common settings menu: D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 27...
  • Page 31 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 28...

  • Page 32: Tone Settings

    Tone settings The screen shot below shows settings for pure tone testing: Function key Description Show settings for the speech banana. Go back. Save user setting (protocol). D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 29...

  • Page 33: Speech Settings

    Speech settings The screen shot below shows settings for Speech testing: Function key Description Phoneme norm curve settings. FF norm curve setting. Go back. Save user setting (protocol). D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 30...

  • Page 34: Auto Settings

    Save a session (19) after testing or alternatively create a new session by holding “Shift” (15) and pressing the “Save Session” button. In the “Save Session” (19) menu it is possible to save sessions, delete and create clients and edit client names. D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 31...

  • Page 35: Save Session

    Return to the session. Save session under the selected client. Clients Function key Description Delete the selected client. Return to the session. Access the sessions saves under the selected client. D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 32...

  • Page 36: Printing

    The printout logo can be configured via the audiometer itself (see below) or via the Diagnostic Suite (in the General Setup a logo image can be downloaded to the AD629 from the PC). PC: Measurements can be transferred to the Diagnostic Suite PC program (see separate •...
  • Page 37 12. It is very important that this file and only this file is present on the USB thumb drive. 13. With the audiometer turned off insert the thumb drive into any available USB port. 14. Turn on the AD629 and push the Temp/Setup button from the Tone test screen. 15. Enter “Common Settings” using the Setup/Tests button.

  • Page 38: Diagnostic Suite

    Important: Please be sure to select the “AD629 (version 2)” (and not “AD629”, which refers to the old version). PC controlled AD629: Unselect this if you want to run the AD629 as a standalone audiometer (i.e. not as a hybrid audiometer) but still being connected to the Diagnostic Suite. When pressing Save Session on the AD629, the session will automatically be transferred to the Diagnostic Suite.

  • Page 39: Sync Mode

    Upload Print Logo and Audiogram Symbols to AD629: A logo for direct print outs can be transferred to the AD629 using the “Up Print Logo” button. The symbol scheme used in the Diagnostic Suite can be transferred to the AD629 (when viewing the build in audiogram) by using the “Upload Custom Symbols”...

  • Page 40: Client Upload

    AD629 memory. The internal AD629 memory can hold up to 1000 clients and 50.000 sessions (audiogram data). On the right side the clients currently stored on the internal AD629 memory (hardware) is down. It • is possible to remove all clients for individual clients using the “Remove all” or “Remove” buttons.
  • Page 41 When pressing the icon the functionality of the “Session download” screen is described: D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 38...

  • Page 42: Hybrid (Online/Pc-Controlled) Mode

    The following screen shots show the Diagnostic Suite AUD tab when running AD629 in “hybrid mode”. This mode allows for the AD629 to be “on-line” connected to the PC – i.e. a trued hybrid audiometer: Operate the unit via a PC and •...

  • Page 43: About Diagnostic Suite

    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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 40...

  • Page 44: Maintenance

    The AD629 had been designed to provide many years of reliable service, but annual calibration is recommended due to possible impact on transducers. We also required recalibrating of the AD629; if something drastic happens to a part of it (e.g., headset or bone conductor is dropped on a hard surface).

  • Page 45: How To Clean Interacoustics Products

    4.2 How to clean Interacoustics products If the surface of the AD629 or parts of it are contaminated, it can be cleaned using a soft cloth moistened with a mild solution of water and dish washing cleaner or similar. The use of organic solvents and aromatic oils must be avoided.

  • Page 46: Warranty

    4.4 Warranty Interacoustics warrants that: • The AD629 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 47: General Technical Specifications

    Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2010), Type 2 Speech Audiometer: IEC 60645-1 (2017)/ANSI S3.6 (2010) type B or B-E. Auto threshold tests: ISO 8253-1 (2010) Calibration Calibration information and instructions is located in the AD629 Service manual DD45: PTB/DTU report 2009 Conduction TDH39: ISO 389-1 1998, ANSI S3.6-2010...
  • Page 48 20 dB below maximum output. Frequency 125Hz to 8kHz (Optional High Frequency: 8 kHz to 20 kHz) range 125Hz, 250Hz, 750Hz, 1500Hz and 8kHz may freely be deselected D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 45...
  • Page 49 125-250 Hz +0/-10 dB 80 dB SPL < 3% 250-4000 Hz ±3 dB 100 dB SPL < 10% 4000-6300 Hz ±5 dB Internal storage 1000 clients / 50.000 sessions D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 46...
  • Page 50 100-240 V~, 50-60Hz max 0.5A 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 47...

  • Page 51: 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 48...
  • Page 52 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 49...
  • Page 53 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 50...
  • Page 54 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 51...
  • Page 55 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 52...
  • Page 56 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 53...
  • Page 57 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 54...
  • Page 58 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-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 55...
  • Page 59 0° - 45° - 90° 0° 45° 90° 135° 180° correction Max SPL RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL Speech -5.5 Speech Noise -5.5 Speech WN -1.5 -2.5 97.5 D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 56...
  • Page 60 -7,0 -6.0 4000 -10,5 -8.0 -14,5 -13,0 -4.5 5000 -11,0 -8.5 -12,5 -14,5 -10.5 6000 -14,5 6300 -10,5 -9.0 -15,5 -11,0 -7.0 8000 +1,5 -1.5 -9,0 -8,5 -10.0 D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 57...
  • Page 61 Cushion [Hz] [dB]* [dB]* [dB]* [dB] 12.5 12.7 1000 12.8 1250 1500 1600 2000 15.1 2500 3000 3150 4000 28.8 5000 6000 6300 8000 26.2 *ISO 8253-1 2010 D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 58...

  • Page 62: Ad629 Pin Assignments

    Data + Data + Ground Ground LAN Ethernet Transmit Data+ Transmit Data- Receive Data+ Not connected Not connected Receive Data- Not connected RJ45 Socket Not connected RJ45 Cable Plug D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 59...

  • Page 63: Electromagnetic Compatibility (Emc)

    Description Length (m) Screened (Yes/No) Monitor Headset w. microphone Bone Conductors Audiometric Headsets Talk Back Microphone Clip-On Free field speakers 0.6+0.9 Patient response switch USB cable D-0133833-A – 2022/09 AD629 - Instructions for Use - EN Page 60...
  • Page 64 Guidance and manufacturer’s declaration - electromagnetic emissions The AD629 is intended for use in the electromagnetic environment specified below. The customer or the user of the AD629 should assure that it is used in such an environment. Emissions test Compliance...
  • Page 65 Guidance and manufacturer’s declaration - electromagnetic Immunity The AD629 is intended for use in the electromagnetic environment specified below. The customer or the user of the AD629 should assure that it is used in such an environment. Immunity Test IEC 60601 Test level...
  • Page 66 If the measured field strength in the location in which the AD629 is used exceeds the applicable RF compliance level above, the AD629 should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AD629.
  • Page 67 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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