Interacoustics AT235 Instructions For Use Manual
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Interacoustics AT235 Instructions For Use Manual

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Instructions for Use - EN
AT235

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  • Page 1 Science made smarter Instructions for Use - EN AT235...

  • Page 2: Table Of Contents

    Important safety instructions ......................6 Malfunction............................7 Connections ............................8 Calibration cavities ..........................8 Changing probe system ........................9 Safety precautions to take when connecting the AT235..............10 Security precautions ........................10 2.10 License ............................. 11 2.11 About Diagnostic Suite ........................12 OPERATING INSTRUCTIONS .......................
  • Page 3 Concerning repair ..........................42 Warranty ............................42 Periodic calibration .......................... 43 TECHNICAL SPECIFICATIONS ......................44 AT235 Technical specifications ....................... 44 Calibration properties ........................46 Reference equivalent threshold values for transducers ..............50 Pin assignments ..........................51 Electromagnetic compatibility (EMC) ....................52...

  • Page 4: Introduction

    1.2 Intended use The AT235 is an automatic impedance audiometer with built-in screening audiometry suited for screening, as well as diagnostic work. Neonatal screening programs will particularly appreciate the presence of high probe tone tympanometry, allowing more dependable tympanometric results in neonates.

  • Page 5: Product Description

    1.4 Product description The AT235 consist of the following parts: Included Parts AT235 instrument. Clinical Probe System Diagnostic Probe System 1, 2 Power supply unit UES65-240250SPA3. Contralateral headphone Daily check cavity. CAT50 (option). DD65v2 Audiometric headset. Patient Response (Option). Printer kit (Option).

  • Page 6: About Warnings And Cautions

    CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE NOTICE is used to address practices not related to personal injury. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 3...

  • Page 7: Unpacking And Installation

    Keep carton for future shipment AT235 comes in its own shipping carton, which is specially designed for the AT235. Please keep this carton. It will be needed if the instrument must be returned for service.

  • Page 8: Markings

    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. The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745.

  • Page 9: Important Safety Instructions

    Interacoustics as repairable by service personnel. 8. For maximum electrical safety, turn off the power from a mains powered instrument when it is left unused.

  • Page 10: Malfunction

    4. Use of accessories, transducers, and cables other than specified, except for transducers and cables sold by Interacoustics or representatives may result in increased emission or decreased immunity of the equipment. For list of accessories, transducers and cables that fulfils the requirements please refer to section 5.4...

  • Page 11: Connections

    The allowed tolerance in the volume measurement is ±0.1 ml for cavities up to 2 ml and ±5% for larger cavities. These tolerances are applicable for all probe tone frequencies. We strongly recommend calibrating probe and contra phone at least once a year. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 8...

  • Page 12: Changing Probe System

    2. Open the 2 locks by pushing them to the sides. 3. Swap to the other probe system. 4. Close the 2 locks by pushing them to the center. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 9...

  • Page 13: Safety Precautions To Take When Connecting The At235

    6. Use updated antivirus and firewall and anti-malware software 7. Implement appropriate backup policy 8. Implement appropriate log retention policy Please follow instructions below. Fig 1. AT235 used with the medically approved power supply UES65-240250SPA3. Medical power supply Mains outlet AT235 alone D-0133834-A –...

  • Page 14: License

    Fig. 2. AT235 used with, a medically approved safety transformer and a wired connection to a PC. AT235 Medical power supply Medically approved safety transformer Mains outlet PC power supply Printer Fig. 3. AT235 used with the UES65-240250SPA3 and printout with HM-E300/MPT-III printer.

  • Page 15: About Diagnostic Suite

    It works by checking the file and folder content of your software version. This is using a 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-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 12...

  • Page 16: Operating Instructions

    Calm and stable positioning while testing is preferred for optimal accuracy. The AT235 should be operated in a quiet environment, so that measurements are not influenced by outside acoustic noises. This may be determined by an appropriately skilled person trained in acoustics.

  • Page 17: Handling And Selection Of Ear Tips

    For more stable testing, we recommend using an extension cord with a mushroom shaped ear tip. Make sure that this ear tip inserts completely into the ear canal. Mushroom shaped ear tips allow you to test ‘hands free’ from the AT235. This reduces the chance of contact noise disturbing the measurement.

  • Page 18: Probe Status

    White The probe has just been attached. Probe status is unknown. If the probe light stays white in any other situation the AT235 may need to be switched off and back on again to regain proper probe status. Blinking AT235 is pausing and/or an interaction is expected.

  • Page 19: Use Of Standard And Clinical Probe System

    Used for manual pump control as well as scrolling through menus and selection possibilities. In the audiometry module the wheel controls the stimulus intensity. Tymp Selects or deselects a tympanogram test from the protocol. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 16...

  • Page 20: Startup

    Right Selects right ear for testing. Left Selects left ear for testing. 3.5.2 Startup The AT235 will always load the last used tympanometry protocol as a starting point. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 17...

  • Page 21: Instrument Settings - Language, Printer, Date & Time, Etc

    For changing the operation language of the system hold the Language button (6) while using the wheel (19) to selecting the language of your choice. The AT235 needs to be restarted for the change to be effectuated. Use the wheel (19) to preselect Display light (A), LED light (B), Date and time (C) and Printer type (D). To make changes at Display light, LED light and the Printer type, hold the Change button (7) while rotating the wheel (19).

  • Page 22: Test And Module Selection

    Tympanometry test screens After startup, the AT235 will have selected the last used impedance protocol and will be ready to start a test. The screen now shown we refer to as the test screen. The following paragraphs describe which information and functionalities are found on the tympanogram, reflex, and audiometry test screens.
  • Page 23 (F) and thereby include or exclude it from testing. When several measurement attempts were done, pressing Data allows choosing which data set is being viewed. Only the viewed data can be saved to a client. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 20...
  • Page 24 (19). Press the attenuator (22) to start and stop recording in manual mode. Switching manual mode off and returning to automatic testing is done by pressing Auto. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 21...
  • Page 25 Pressing the arrow up button moves the reflex selection to the previous reflex row. Moving the selection sideways is done with the wheel (19). D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 22...
  • Page 26 In manual mode (O) the Add Stimulus button is available and allows adding new reflex rows. In manual mode (O) the Add Level button is available and allows including additional test intensities. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 23...

  • Page 27: Audiometry Test Screen

    The measurement type (HL, MCL, UCL or Tinnitus is shown) as well as the presentation type (tone or pediatric noise) and the test frequency is shown. For clarity second channel information is shown, although the AT235 cannot contain licenses to use this second channel.

  • Page 28: Start And Stop Of A Tympanometric Test

    Start and stop of a tympanometric test After startup, the AT235 is ready to automatically start a measurement as soon as it detects that the probe is in the ear. When the probe is in the ear the test can be manually stopped (or paused) and again started by pressing the “Start/stop”...

  • Page 29: Save

    Use the wheel (19) to scroll and use “Enter” (22) to select letter to be inserted for the client’s last name. A clear, backspace, shift, caps lock and spacebar function are found under the soft key buttons (4 to 8). Press the “Done” button (13) to proceed. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 26...

  • Page 30: View Historical Sessions

    Press the “View” button (13) to show the historic session in a separate window. Use the “Next” button (13) to browse through the tests in within the session. Return to the test screen by pressing “Back” three times. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 27...

  • Page 31: Operating In Sync Mode (Only With Diagnostic Suite)

    If the Diagnostic Suite crashes and the details can be logged by the system, the Crash Report window will appear on the test screen (as shown below). The crash report provides information to Interacoustics about the error message and extra information can be added by the user outlining what they were doing before the crash occurred to assist in fixing the problem.

  • Page 32: Instrument Setup

    Select Menu | Setup | Suite setup… to open general suite settings. Important: Both at the AUD module and the IMP module, please be sure to select the “AT235 (version 3)” (and not “AT235”, which refers to the old version).

  • Page 33: Using Sync Mode

    Save & Exit saves the current session in Noah or OtoAccess® (or to a commonly used XML file when running in standalone mode) and exits the Suite. Toggle Ear changes from right to left ear and vice versa. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 30...
  • Page 34 If more tests than can fit in the window are included in the protocol, a scrollbar will be visible. A white checkmark indicates that (at least some) data for this test was saved. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 31...

  • Page 35: Using Aud Sync

    Save & Exit saves the current session in Noah or OtoAccess® (or to a commonly used XML file when running in standalone mode) and exits the Suite. Tone test shows the tone audiogram. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 32...
  • Page 36 Transfer allowing updating the PC screen with data currently available in the audiometry module of the AT235. The counseling overlays can be activated on a separate patient monitor. Phonemes, sound examples, speech banana, a severity indication and maximum testable values are available as overlay.

  • Page 37: Sync Mode

    3.7.3 SYNC mode If there are several sessions stored on the AT235 (under one or more patients) then the Sync tab is supposed to 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 38: Client Upload

    AT235 memory. The internal AT235 memory can hold up to 500 clients and 50.000 sessions. • On the right side the clients currently stored on the internal AT235 memory (hardware) is down. It is possible to remove all clients for individual clients using the “Remove all” or “Remove” buttons. 3.7.5...
  • Page 39 D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 36...

  • Page 40: Maintenance

    10) Listen at low levels for any sign of noise, hum, or unwanted sounds (break-through arising when a signal is introduced in another channel) or for any change in tone quality as masking is introduced. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 37...

  • Page 41: General Maintenance Procedures

    Do not let parts that have been in contact with fluids dry before cleaning • • Rubber ear-tips or foam ear-tips are single use components Ensure isopropyl alcohol does not come into contact with any screens on the AT235 • Recommended cleaning and disinfection solutions: •...

  • Page 42: Cleaning The Probe Tip

    Only insert the cleaning brush from inside out, this will ensure that the dirt is pushed out of the probe instead of into the probe and as well protect the gasket from being damaged. Never clean inside the probe holes. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 41...

  • Page 43: Concerning Repair

    REPORT every time when the component/product is sent for service/repair to Interacoustics. 4.5 Warranty INTERACOUSTICS guarantees that: The AT235 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 •...

  • Page 44: Periodic Calibration

    ANSI/ASA and/or IEC and the device specifications. The calibration procedure will validate all relevant performance requirements given in ANSI/ASA and/or IEC. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 43...

  • Page 45: Technical Specifications

    5.1 AT235 Technical specifications General 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. Approval of the quality system is made by TÜV – identification no. 0123.
  • Page 46 -10 to 100 6000 -10 to 100 8000 -10 to 90 Test types Auto Threshold Determination (Modified Hughson Westlake). Auto testing: duration 1-2 s adjusted in 0.1 s intervals. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 45...

  • Page 47: Calibration Properties

    Admittance can vary inside: ± 4%. chances influence on the The pressure accuracy is: ±10 daPa or 10%, impedance measurement whichever is greater. in the specified range (97300 – 105300 Pascal). D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 46...
  • Page 48 The risk of artifacts at higher stimulus levels in reflex measurements are minor and will not activate the reflex detection system. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 47...
  • Page 49 21 (1600 Hz) 2000 11.7 3000 -0.8 -0.5 31 (3150 Hz) 4000 -1.6 -0.8 6000 15.5 20.5 3 26 (6300 Hz) 8000 *All figures in bold are Interacoustics Standard values. D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 48...
  • Page 50 The performance and specifications of the instrument can only be guaranteed if it is subject to technical maintenance at least once per year. This should be conducted by a workshop authorized by Interacoustics. Interacoustics puts diagrams and service manuals at the disposal of authorized service companies.

  • Page 51: Reference Equivalent Threshold Values For Transducers

    [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] [dB HL] 1000 1500 2000 3000 4000 6000 8000 10000 D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 50...

  • Page 52: Pin Assignments

    Min. load impedance: Pin 1: CH1 GND Pin 2: CH1 OUT Probe system 15-pin D-sub high density with air connection Data I/O: USB type”B” USB port for communication D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 51...

  • Page 53: Electromagnetic Compatibility (Emc)

    EMC information presented in this chapter. The AT235 has been tested for EMC emissions and immunity as a standalone AT235. Do not use the AT235 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 54 Guidance and manufacturer’s declaration - electromagnetic immunity The AT235 is intended for use in the electromagnetic environment specified below. The customer or the user of the AT235 should assure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 55 Guidance and manufacturer’s declaration — electromagnetic immunity The AT235 is intended for use in the electromagnetic environment specified below. The customer or the user of the AT235 should assure that it is used in such an environment, Immunity test IEC / EN 60601 Compliance level Electromagnetic environment –...
  • Page 56 DD65 v2 Passive attenuation 2.0m Screened audiometric headset IP30 Insert Phone 10ohm single 0.5m Screened contra DD45 Audiometric Headset P3045 0.5m Screened IP30 Insert Phone 10ohm set 0.5m Screened D-0133834-A – 2022/09 AT235 - Instructions for Use - EN Page 55...

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