Interacoustics Callisto Instructions For Use Manual
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Interacoustics Callisto Instructions For Use Manual

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Instructions for Use – US
Callisto™
Instructions for Use - EN

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Summary of Contents for Interacoustics Callisto

  • Page 1 Science made smarter Instructions for Use – US Callisto™ Instructions for Use - EN...

  • Page 3: Table Of Contents

    Unpacking and inspection ....................7 Marking ..........................8 Patient applied parts that are not conductive and can be immediately released f rom the patient..8 Callisto™ - connection panel dictionary ................. 8 Callisto™ - indicators: ......................9 Sof tware installation ......................9 2.5.1...
  • Page 4 GENERAL TECHNICAL SPECIFICATIONS ..............53 Ref erenc e equivalent threshold values f or transducers and maximum hearing level ....53 Pin assignments .........................53 Electromagnetic Compatibility (EMC) ...................53...

  • Page 5: Introduction

    Indications for use The Callisto™ with AC440 is intended to be used f or the detection and diagnosis of suspected hearing loss. The outcomes of which can be used f or f urther testing procedures and/or the f itting of hearing aid devices.

  • Page 6: Product Description

    Product description The Callisto™ is a Hearing Aid Analyzer that interf aces with integrated audiologic software modules on a PC. Depending on the installed sof tware modules they can perf orm: Audiometry (AC440) • • Real Ear Measurements (REM440) including Visible Speech Mapping Hearing Instrument Testing (HIT) •...

  • Page 7: Included And Optional Parts And Accessories

    Coupler Seal Wax • • OtoAccess® Database • • Accessory bracket • Travel trolly Applied part as according to IEC60601-1 This part is not certified according to IEC 60601-1. D-0101246-Q – 2022/05 Page 3 Callisto™ Instructions for Use - US...

  • Page 8: Warnings And Precautions

    If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears, e.g. unwanted noise in headphones. If disturbances are observed, try to separate the Callisto f rom the disturbing device. Please ref er to the section f or Electromagnetic Compatibility (EMC).
  • Page 9 - exchange of transducers requires a new calibration. Interacoustics will not make any guarantee to the f unctionality of the system if any other sof tware is installed, with exception of the Interacoustics measurement (AC440/REM440) modules and AuditBase system4, OtoAccess®...

  • Page 10: Malfunction

    Interacoustics A/S cannot be held liable f or your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsof t.

  • Page 11: 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 Callisto™ f or a period, please ensure it is stored under the conditions specif ied in the technical specif ications: D-0101246-Q – 2022/05 Page 7 Callisto™...

  • Page 12: Marking

    WEEE 2002/96/EC Please ref er to warning and pre-cautions The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV – identif ication no. 0123.

  • Page 13: Callisto™ - Indicators

    Supported Noah Office Systems We are compatible with all Noah-integrated of f ice systems which are running on Noah and Noah engine. To use the sof tware with a database, make sure the database is installed prior to the Callisto™ Suite installation. Follow the manuf acturer’s installation instructions provided to install the relevant database.

  • Page 14: Software Installation Windows®11, Windows®10, Windows®8.1, And Windows®8

    On checking the box to accept this, the Install button will become available, click “Install” to begin the installation. Note: There are also options to include the installation of Interacoustics Universe and Callisto documentation within this step. They are by def ault checked on; you can disable this if you wish.
  • Page 15 Should you wish to install the sof tware to a dif f erent location than the def ault then please click on ’Options’ ahead of ’Install’ D-0101246-Q – 2022/05 Page 11 Callisto™ Instructions for Use - US...
  • Page 16 Depending on your Windows User Account settings the f ollowing dialog may appear. Select “Yes” to continue with the installation. Please wait while the Callisto™ Suite is being installed. When the installation is complete, the dialog box below is shown. Click “Close” to f inish the D-0101246-Q –...
  • Page 17 The Callisto™ Suite is now installed. D-0101246-Q – 2022/05 Page 13 Callisto™ Instructions for Use - US...

  • Page 18: Driver Installation

    Driver installation Now that the Callisto™ Suite sof tware is installed, you must install the driver f or the Callisto™. Connect the Callisto hardware to the PC via the USB connection. The system will now automatically detect the hardware and a pop- up will appear on the task bar near the clock indicating that the driver is installed and the hardware is ready f or use.

  • Page 19: Sound Device Settings For Windows®8/Windows®10/Windows®11

    “SoundMAX Integrated Digital HD Audio Def ault Device. In the “Recording” tab make sure to set the def ault recording device to your original device. In this case “Microphone USB Audio Device”. D-0101246-Q – 2022/05 Page 15 Callisto™ Instructions for Use - US...

  • Page 20: Using With Databases

    How to configure an alternative data recovery location The Callisto™ Suite has a backup location f or data to be written in the case that the sof tware is accidentally terminated or the system crashes. The f ollowing location is the def ault storage f older C:\ProgramData\Interacoustics\Callisto Suite\, however this can be changed by f ollowing the below instructions.

  • Page 21: About Callisto™ 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-0101246-Q – 2022/05 Page 17 Callisto™ Instructions for Use - US...
  • Page 22 D-0101246-Q – 2022/05 Page 18 Callisto™ Instructions for Use - US...

  • Page 23: Operating Instructions

    Operating instructions The instrument is switched on automatically when the USB cable is connected to both the Callisto™ and the PC. A green indication light on the Callisto™ will indicate that it is “ON”. When operating the instrument, please observe the f ollowing general precautions: 1.

  • Page 24: Ac440 Using The Tone Screen Elements

    Note that the extended range button will f lash when it needs activation f or reaching higher intensities. To switch on the extended range automatically, select the Switch extended range on automatically by going to the setup menu. D-0101246-Q – 2022/05 Page 20 Callisto™ Instructions for Use - US...
  • Page 25 High Frequencies show f requencies on the audiogram (up to 16 kHz f or the Callisto™). However, you will only be able to test in the f requency range the high f requency headset is calibrated f or. High Frequency Zoom activates high f requency testing and zooms in on the high f requency range.
  • Page 26 Toggle Masking Help will activate or deactivate the Masking Help f eature. For more inf ormation on Masking Help, please ref er to the Callisto™ “Additional Inf ormation” or the “Masking Help Quick Guide” documents. Toggle Automasking will activate or deactivate the Automasking f eature.
  • Page 27 Af ter saving the session, comment changes can only be made within the same day until the date changes (at midnight). Note: these timef rames are limited by HIMSA and the Noah sof tware and not by Interacoustics. The Output list f or channel 1 provides the option to test through head phones, bone conductor, f ree f ield speakers or insert phones.
  • Page 28 Notice that the dB dial setting will f lash when trying to go louder than the maximum available intensity. TENs test requires an additional license for the AC440. If not purchased, the stimulus is grayed out. D-0101246-Q – 2022/05 Page 24 Callisto™ Instructions for Use - US...
  • Page 29 An examiner can also select which protocol must be selected at start up (by right mouse click on the protocol selection list). D-0101246-Q – 2022/05 Page 25 Callisto™ Instructions for Use - US...

  • Page 30: Using The Speech Screen

    Binaural and Aided f unction allows f or indicating if the test is perf ormed binaurally or while the patient is wearing hearing aids. D-0101246-Q – 2022/05 Page 26 Callisto™ Instructions for Use - US...
  • Page 31 On the lef t the dB value f or Ch1 is shown and on the right side f or Ch2. In the centre of the current Speech Score in % and the Word Counter monitors the number of words presented during the test. D-0101246-Q – 2022/05 Page 27 Callisto™ Instructions for Use - US...

  • Page 32: Speech Audiometry In Graph Mode

    3) The shaded area illustrates how high in intensity the system will allow. The Extended Range +20 dB button can be pressed to go higher. The maximal loudness is determined by the transducer calibration. D-0101246-Q – 2022/05 Page 28 Callisto™ Instructions for Use - US...

  • Page 33: Speech Audiometry In Table Mode

    MCL (Most Comf ortable Level) and UCL (Uncomf ortable Loudness level) speech audiometry. Please ref er to the Callisto™ Additional Inf ormation document f or more inf ormation about SRT testing. D-0101246-Q – 2022/05 Page 29 Callisto™...
  • Page 34 Upon changing Transducer, Masking, and/or Aided re-testing an additional WR entry will appear in the WR table. This allows f or multiple WR measurements to be shown in the WR table. Please ref er to the Callisto™ Additional Inf ormation document f or more inf ormation about Word Recognition testing.

  • Page 35: Pc Keyboard Shortcuts Manager

    2. Import shortcuts: Use this f unction to import shortcuts that have already been exported f rom another computer 3. Restore all defaults: Use this f unction to restore the PC shortcuts to Factory Settings def ault D-0101246-Q – 2022/05 Page 31 Callisto™ Instructions for Use - US...

  • Page 36: Technical Specifications Of The Ac440 Software

    3.2.4 Technical specifications of the AC440 software Medical CE-mark: The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV – identif ication no. 0123.
  • Page 37 Storing capability Tone audiogram: dB HL, MCL, UCL, Tinnitus, R+L Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural. Compatible software Noah 4, OtoAccess® and XML compatible D-0101246-Q – 2022/05 Page 33 Callisto™ Instructions for Use - US...

  • Page 38: Rem440 Screen Elements

    In other words the curve f reezes at a particular moment while the test continues. NOTE: The Freeze Curve option only works f or broadband (ex: ISTS) signals in the continuous mode. D-0101246-Q – 2022/05 Page 34 Callisto™ Instructions for Use - US...
  • Page 39 NOTE: UCL thresholds must be entered on the audiogram f or the red line to appear when the UCL button is active. To deactivate this f eature, press on the UCL button again. D-0101246-Q – 2022/05 Page 35 Callisto™ Instructions for Use - US...
  • Page 40 Note that the calibration is sensitive to noise and the clinician should theref ore ensure that the room is quite while calibrating. D-0101246-Q – 2022/05 Page 36 Callisto™ Instructions for Use - US...
  • Page 41 Press the button and insert the pref erred target values in the table as illustrated below. When satisf ied click OK. Table View button provides a chart view of the measured and target values. D-0101246-Q – 2022/05 Page 37 Callisto™ Instructions for Use - US...
  • Page 42 The colour on each test button (in this case blue) indicates the colour selected f or each curve. START/STOP button initiates and ends the current test. Note that af ter pressing START the text on the button will change to STOP. D-0101246-Q – 2022/05 Page 38 Callisto™ Instructions for Use - US...
  • Page 43 Tick the ones that are to be displayed on the graph. Right clicking on the input level in the curve display will give the f itter various options D-0101246-Q – 2022/05 Page 39 Callisto™ Instructions for Use - US...
  • Page 44 When opening the Suite, the system will search f or 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 lef t). D-0101246-Q – 2022/05 Page 40 Callisto™ Instructions for Use - US...

  • Page 45: Rem Software - Technical Specifications

    3.3.1 REM software - Technical specifications Medical CE-mark: The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV – identif ication no.

  • Page 46: The Hit440 Screen

    In other words the curve f reezes at a particular moment while the test continues. NOTE: The Freeze Curve option only works in an end user-created protocol, f or broadband (ex: ISTS) signals in the continuous mode. D-0101246-Q – 2022/05 Page 42 Callisto™ Instructions for Use - US...
  • Page 47 Advanced view Simple view Normal and reversed coordinate system buttons enable you to toggle between reversed and normal graph. D-0101246-Q – 2022/05 Page 43 Callisto™ Instructions for Use - US...
  • Page 48 Test protocols can be created and adjusted in the HIT440 Setup. Start/Stop button initiates and ends all tests. Note that af ter pressing START the text on the button will change to STOP. D-0101246-Q – 2022/05 Page 44 Callisto™ Instructions for Use - US...
  • Page 49 The hardware indication picture indicates whether the hardware is connected. When opening the Suite, the system will search f or the hardware. If it does not detect the hardware, then the system will automatically continue in simulation mode. D-0101246-Q – 2022/05 Page 45 Callisto™ Instructions for Use - US...

  • Page 50: Hit440 Software - Technical Specifications

    3.4.1 HIT440 software - Technical specifications Medical CE-mark The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identif ication no. 0123.

  • Page 51: Using The Print Wizard

    If you want to use a template f or general use or select an existing one f or printing: Go to Menu/ Print/Print layout… Callisto™ Suite tabs (AUD or REM). b. If you want to create a template or select an existing one to link to a specif ic protocol: Select the Module tab (AUD or REM) relating to the specif ic protocol and select Menu/Setup/AC440 setup or Menu/Setup/REM440 setup.
  • Page 52 Right clicking on a specif ic template provides a drop down menu of f ering an alternative method f or perf orming the options as described above: For more information related to the Print reports and Print Wizard, please refer to the Callisto™ Additional Information document or the Print Report Quick Guide on www.interacoustics.com...

  • Page 53: Maintenance

    • electrical, and mechanical properties are correct. This should be made by an authorised workshop to guaranty proper service and repair as Interacoustics provides the necessary circuit diagrams etc. to these repair shops. To ensure that the reliability of the instrument is kept, it is recommended that the operator at short •...

  • Page 54: Concerning Repair

    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 55: Replacement Of Consumables

    . These are single use parts. For ordering of new parts, please ref eree to the local Interacoustics distributor. 4.5.2 Probe tubes The REM probe tubes are used together with the IMH60/IMH65 headset. They are connected to the thin tube on the top of the IMH60/65 headset as shown on the image below.

  • Page 56: Ear Tips

    They are replaced by pressing them on the SPL60 probe or pulling them of f . The Ear tips are single use. For ordering of new parts, please ref eree to the local Interacoustics distributor. D-0101246-Q – 2022/05 Page 52 Callisto™...
  • Page 57 Callisto™ general technical specifications Medical CE-mark: The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I Approval of the quality system is made by TÜV – identif ication no. 0123.
  • Page 59 Callisto RETSPL-HL Tabel 5.1 Survey of Reference and max Hearing Level Tone Audiometer Pure Tone RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω...
  • Page 60 Callisto RETSPL-HL Tabel Pure Tone max HL Transducer DD45 TDH39 DD65V2 DD450* HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm...
  • Page 61 Callisto RETSPL-HL Tabel NB noise effective masking level Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm...
  • Page 62 Callisto RETSPL-HL Tabel NB noise max HL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm...
  • Page 63 Callisto RETSPL-HL Tabel ANSI Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 64 Callisto RETSPL-HL Tabel IEC Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 65 Callisto RETSPL-HL Tabel Sweden Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 66 Callisto RETSPL-HL Tabel Norway Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 67 Callisto RETSPL-HL Tabel Japan Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 68 Callisto RETSPL-HL Tabel SPL Speech RETSPL Transducer DD45 TDH39 DD65V2 DD450 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω 10 Ω 12.5 Ω Coupler 6ccm 6ccm Artificial ear...
  • Page 69 Callisto RETSPL-HL Tabel Free Field ANSI S3.6-2010 Free Field max SPL Free Field max HL is found by subtracting ISO 389-7 2005 the selected RETSPL value Binaural to Binaural Free Field Power Monaural 0° 45° 90° correction Tone Frequency RETSPL...
  • Page 70 Callisto RETSPL-HL Tabel ANSI Free Field Free Field max SPL ANSI S3.6-2010 Free Field max HL is found by subtracting the selected RETSPL value Binaural to Binaural Free Field Power Monaural 0° 45° 90° correction 0° - 45° - 90°...
  • Page 71 Callisto RETSPL-HL Tabel Japan Free Field Free Field max SPL ISO 389-7 2005 Free Field max HL is found by subtracting the selected RETSPL value Binaural to Binaural Free Field Power Monaural 0° 45° 90° correction 0° - 45° - 90°...
  • Page 72 Callisto RETSPL-HL Tabel Sound attenuation values for earphones Attenuation TDH39/DD45 with EAR 3A IP30 MX41/AR or PN 51 DD65v2 HDA200 HDA300 EAR 5A Cushion Frequency [dB]* [dB]* [dB] [dB]* [dB] [Hz] 12.5 11.7 15.5 12.7 19.5 23.4 26.1 28.5 28.2 1000 32.4...
  • Page 73 Callisto Pin assignments Socket Connector Pin 1 Pin 2 Pin 3 Pin 4 Left Ground Signal Right Bone 6.3mm Mono Signal - Signal + Pin 1 & 2 are Pat. Resp. connected to Ground 6.3mm Stereo TB-mic. or Coupler-mic. TB/Coupler...
  • Page 75 5.3 Electromagnetic Compatibility (EMC) • This instrument is suitable in hospital environments except for near active HF surgical equipment and RF shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high • Use of this instrument adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
  • Page 76 Callisto™ according to the EMC information presented in this chapter. The Callisto™ has been tested for EMC emissions and immunity as a standalone instrument. Do not use the Callisto™ 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 77 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Callisto™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Callisto™ should assure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 78 Guidance and manufacturer’s declaration — electromagnetic immunity The Callisto™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Callisto™ should assure that it is used in such an environment, Immunity test IEC / EN 60601...
  • Page 79 If the measured field strength in the location in which the Callisto™ is used exceeds the applicable RF compliance level above, the Callisto™ should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Callisto™.
  • Page 81 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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