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

Portable audiometry & rem
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Instructions for Use - US
Callisto™
Portable Audiometry & REM
Item No. 8101932 – ver. 11/2014

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  • Page 1 Instructions for Use - US Callisto™ Portable Audiometry & REM Item No. 8101932 – ver. 11/2014...
  • Page 3 Instructions for Use - US...

  • Page 5: Table Of Contents

    Warnings and Precautions ....................3 UNPACKING AND INSTALLATION .................. 7 Unpacking and Inspection ....................7 Marking ..........................7 Callisto™ - Connection Panel Dictionary ................8 Callisto™ - Indicators: ......................8 Software Installation ......................9 2.5.1 Software Installation Windows®7 and Windows®8 ..........10 2.5.2...

  • Page 7: Introduction

    Intended Operator The Callisto™ is intended to be operated by an Audiologist, ENT professional or a person with equivalent knowledge. Using the instrument without adequate knowledge may lead to erroneous results and may endanger the patients hearing Intended Patient Population This instrument is intended for all patient groups regarding sex, age and health.

  • Page 8: Included And Optional Parts And Accessories

    Standard USB Cable (2m)  Mouse Pad Optional Parts for the Callisto™ Unit  Wheeled Carrying Case  Callisto™ Foam Insert (optional bag with wheels)  OtoAccess V1.01 Database CD, Complete AC440 REM440 AC440 Standard Parts REM440 Standard Parts ...

  • Page 9: Warnings And Precautions

    If disturbances are observed, try to separate the Callisto from the disturbing device. Please refer to the section for Electromagnetic Compatibility (EMC).
  • Page 10 - exchange of transducers requires a new calibration. Interacoustics will not make any guaranty 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™...
  • Page 11 Callisto™ Instruction for Use - US Page 5 Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted municipal waste. Electrical and electronic waste may contain hazardous substances and therefore have to be disposed of separately. Such products will be marked with the crossed-out wheelie-bin image shown to the left.
  • Page 12 Callisto™ Instruction for Use - US Page 6...

  • Page 13: 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 satisfaction. Storage If you need to store the Callisto™ for a period, please ensure it is stored under the conditions specified in the technical specifications: 2.2 Marking...

  • Page 14: Callisto™ - Connection Panel Dictionary

    Callisto™ Instruction for Use - US Page 8 2.3 Callisto™ - Connection Panel Dictionary Position: Symbol: Function: Insitu L. Connection of Insitu Headset Left Insitu R. Connection of Insitu Headset Right TB/Coupler Socket for talk back microphone or coupler base...

  • Page 15: Software Installation

    2.5 Software Installation To know before starting the installation. You must have administrative rights to the computer on which you are installing the Callisto™ Suite. DO NOT connect the Callisto™ hardware to the computer before the software has been installed! Please also refer to the section “Warnings and precautions”...

  • Page 16: Software Installation Windows®7 And Windows®8

    2.5.1 Software Installation Windows®7 and Windows®8 Insert the installation DVD and follow the steps below to install the Callisto TM Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD.
  • Page 17 Callisto™ Instruction for Use - US Page 11 Please wait while the Callisto™ Suite is being installed. If any of the dialogs below are shown, click “Install”...
  • Page 18 Callisto™ Instruction for Use - US Page 12 When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Callisto™ Suite is now installed.

  • Page 19: Software Installation Windows®8.1

    Page 13 2.5.2 Software Installation Windows®8.1 Insert the installation DVD and follow the steps below to install the Callisto TM Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD.
  • Page 20 Callisto™ Instruction for Use - US Page 14 Please wait while the Callisto™ Suite is being installed. If any of the dialogs below are shown, click “Install” to proceed with the installation.
  • Page 21 Callisto™ Instruction for Use - US Page 15 When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Callisto™ Suite is now installed.

  • Page 22: Software Installation Windows®Xp

    Page 16 2.5.3 Software Installation Windows®XP Insert the installation DVD and follow the steps below to install the Callisto TM Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD.
  • Page 23 Callisto™ Instruction for Use - US Page 17 When the dialog below is shown, click “Continue Anyway” to proceed with the installation. 4. If the below dialogue boxes appear please click ‘Yes’ on both to proceed with the installation.
  • Page 24 Callisto™ Instruction for Use - US Page 18 When the installation is complete, the dialog box below is shown.Click “Close” to finish the installation. The Callisto™ Suite is nowinstalled.

  • Page 25: Driver Installation

    Page 19 2.6 Driver Installation Now that the Callisto TM Suite software is installed, you must install the driver for the Callisto TM . For Windows ® 7: Connect the Callisto TM hardware to the PC via the USB connection.
  • Page 26 Callisto™ Instruction for Use - US Page 20 4. Select “Install the software automatically (Recommended)”. 5. Click “Next” and wait while the software installs.
  • Page 27 6. Press “OK” if the dialog below appears. The system automatically selects the recommended location for the files (C:\Program Files\Interacoustics\Callisto™ Suite\Drivers\Magnum Driver\x86). 7. When the installation is complete, the dialog box below is shown. Click “Finish”. The Callisto™ driver is now installed.

  • Page 28: Sound Device Settings

    Callisto™ Instruction for Use - US Page 22 8. To finalize the installation process in standalone, start the Callisto™ Suite by clicking Start | All Programs | Interacoustics | Suite for Callisto™ modules | Suite Launcher. Select the desired Regional settings and Language when the pop-up below appears.

  • Page 29: Sound Device Settings For Windows®7

    Callisto™ Instruction for Use - US Page 23 2.6.2 Sound Device Settings for Windows®7 In the “Start” menu find the “Control Panel” and select “Sound”. In the “Playback” tab make sure to set the default playback device to the original default device. In this case “SoundMAX Integrated Digital HD Audio Default Device.

  • Page 30: Sound Device Settings For Windows®Xp

    Callisto™ Instruction for Use - US Page 24 2.6.3 Sound Device Settings for Windows®XP: In the “Start” menu find the “Control Panel” and select “Sound and Audio Devices”. In the “Audio” tab make sure to reset your sound playback/recording settings to the original default device. In this case “Conexant HD...

  • Page 31: Using With Databases

    5. Press “OK” and your module will be launched when the appropriate button gets pushed. 2.7.2 Noah 4 If you are using HIMSA’s Noah4 Office System,, the Callisto software will install itself automatically in the menu bar on the Noah4 start page, along with all the other software modules.

  • Page 32: How To Install A Shortcut For Launching With Standalone Version

    You can find the executable file (.exe) for this purpose through the following path start/All Programs/Interacoustics/Suite for Callisto™ Suite Launcher. Right click on the last item with the mouse and select “Create shortcut”. However, you will not be able to save your tests and measurements when using this way of working.in OtoAccess™, but it will be stored locally with a save indication by a time and date in the suite software.

  • Page 33: Operating Instructions

    Page 27 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 following general precautions: 1.

  • Page 34: Ac440 Using The Tone Screen Elements

    Callisto™ Instruction for Use - US Page 28 3.1 AC440 Using the Tone Screen Elements The following section describes the elements of the tone screen. Menu provides access to Print, Edit, View, Tests Setup, and Help. Print allows for printing the data acquired during the session Save &...
  • Page 35 High Frequencies show frequencies on the audiogram (up to 16 kHz for the Callisto™). However, you will only be able to test in the frequency range the high frequency headset is calibrated for. High Frequency Zoom activates high frequency testing and zooms in on the high frequency range.
  • Page 36 Toggle Masking Help will activate or deactivate the Masking Help feature. For more information on Masking Help, please refer to the Callisto “Additional Information” or the “Masking Help Quick Guide” documents. Toggle Automasking will activate or deactivate the Automasking feature.
  • Page 37 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. The Output list for channel 1 provides the option to test through head phones, bone conductor, free field speakers or insert phones.
  • Page 38 Callisto™ Instruction for Use - US Page 32 Sim/Alt allows toggling between Simultaneous and Alternate presentation. Ch1 and Ch2 will present the stimulus simultaneously when Sim is selected. When Alt is selected, the stimulus will alternate between Ch1 and Ch2.
  • Page 39 Callisto™ Instruction for Use - US Page 33 The hardware indication picture indicates whether the hardware is connected. Simulation mode is indicated when operating the software without hardware. When opening the Suite the system will automatically search for the hardware. If it does not detect the hardware a dialog box pops up and asks if you want to continue in simulation mode.

  • Page 40: Using The Speech Screen

    Callisto™ Instruction for Use - US Page 34 3.2 Using the Speech Screen The following section describes the elements of the speech screen: Input Level allow for adjusting the input level to 0 VU for the selected input. This ensures that correct calibration is obtained for the microphone.
  • Page 41 Callisto™ Instruction for Use - US Page 35 The Output list for channel 1 provides the option to test through the desired transducers. Note that the system only shows the calibrated transducers. The Input list for channel 1 provides the option to select white noise (WN), speech noise (SN), microphone (Mic 1) and wavefile.

  • Page 42: Speech Audiometry In Graph Mode

    Callisto™ Instruction for Use - US Page 36 3.2.1 Speech Audiometry in Graph Mode Graph mode presentation settings under “Test Symbols” in the lower left corner and in the presentation options (Ch1 and Ch2) shows where you can adjust the test parameters during the test.

  • Page 43: Speech Audiometry In Table Mode

    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 table. Please refer to the Callisto Additional Information document for more information about SRT testing.
  • Page 44 Upon changing Transducer, Masking, and/or Aided re-testing an additional WR entry will appear in the WR table. This allows for multiple WR measurements to be shown in the WR table. Please refer to the Callisto Additional Information document for more information about Word Recognition testing.

  • Page 45: Pc Keyboard Shortcuts Manager

    Callisto™ Instruction for Use - US Page 39 3.2.3 PC Keyboard Shortcuts Manager The PC Shortcut Manager allows the user to personalize PC shortcuts in the AC440 Module. To access the PC Shortcut Manager: Go to AUD module │Menu │ Setup │PC Shortcut Keys To view the default shortcuts, click on the items in the left hand column (Common 1, Common 2, Common 3, etc.)
  • Page 46 Page 40 Technical Specifications of the AC440 Software 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 – identification no. 0123.

  • Page 47: Rem440 Screen Elements

    Callisto™ Instruction for Use - US Page 41 3.3 REM440 Screen Elements Menu provides access to File, Print, Edit, View, Mode, Setup, Help Print button allows you to will print the test results currently displayed on the screen. Save & New session button saves the current session in Noah or OtoAccess™...
  • Page 48 Callisto™ Instruction for Use - US Page 42 List of Protocols allows you to select a test protocol (default or user defined) to use in the current test session. Temporary Setup button allows for making temporary changes to the selected test protocol. The changes will be valid for the current session only.
  • Page 49 Callisto™ Instruction for Use - US Page 43 On Top Mode button converts the REM440 into an on top window that includes only the most essential REM features. The window is automatically placed on top of other active software programs such as the relevant hearing aid fitting software.
  • Page 50 Callisto™ Instruction for Use - US Page 44 Simple View/Advanced View buttons toggle between an advanced screen view (including the test and fitting prescription information on the right hand side) and a more simple view with a larger graph only.
  • Page 51 Callisto™ Instruction for Use - US Page 45 Table View button provides a chart view of the measured and target values. Show Cursor on Graph locks the cursor to the curve, displaying the frequency and intensity at any given point along the measure curve.
  • Page 52 Callisto™ Instruction for Use - US Page 46 instrument produces the monitored signal meaning that it cannot be controlled by the equipment. 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.
  • Page 53 Callisto™ Instruction for Use - US Page 47 Curve Display Options are found in the lower right hand corner. If you have measured more curves of the same type (e.g. REIG curves), they will be listed by their input level. Tick the ones that are to be displayed on the graph.
  • Page 54 Callisto™ Instruction for Use - US Page 48...
  • Page 55 Page 49 REM440 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 – identification no. 0123.

  • Page 56: Using The Print Wizard

    If you want to use a template for general use, or select an existing one for 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 specific protocol: Select the Module tab (AUD or REM) relating to the specific protocol and select Menu/Setup/AC440 setup or Menu/Setup/REM440 setup.
  • Page 57 Right clicking on a specific template provides a drop down menu offering an alternative method for performing 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...
  • Page 58 Callisto™ Instruction for Use - US Page 52...

  • Page 59: Maintenance

    The instrument must go through at least one annual overhaul, to ensure that the acoustical, electrical and mechanical properties are correct. This should be made by an authorised workshop in order to guaranty proper service and repair as Interacoustics provides the necessary circuit diagrams etc. to these repair shops.

  • Page 60: Concerning Repair

    Page 54 4.3 Concerning Repair Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if: 1. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised persons, 2.

  • Page 61: General Technical Specifications

    5 General Technical Specifications Callisto™ General 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 – identification no. 0123.

  • Page 62: Reference Equivalent Threshold Values For Transducers And Maximum Hearing Level Settings Provided At Each Test Frequency

    Callisto™ Instruction for Use - US Page 56 Battery : NP120 3.7V 1700 mAH battery lithium ion 53x35.2x11. Battery working voltage : 3.2 to 4.2V Operation environment: 30 – 90% Rel. Humidity: 15-35° Temperature: 98 kPa – 104 kPa Ambient Pressure: Transport temperature: -20-50 °C...
  • Page 63 Survey of Reference and max Hearing Level Tone Audiometer ANSI TDH39 IEC TDH39 Coupler: ANSI S3.7-1995 (NBS-9A) / Coupler: IEC 60318-3 1998 (6ccm) IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Audiometer Tone Narrow Band Noise Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 ISO 389-1 1998 ISO 389-4 1994...
  • Page 64 75.0 20000² 86.0 89.0 ¹ The RETSPL is copy from ISO389-8 2001. WhiteNoise ² 18-20 kHz is estimated of Interacoustics. ANSI EAR 3A IEC EAR 3A Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Coupler: IEC 60318-5 2006 Tone Audiometer...
  • Page 65 ANSI Ear 5A IEC Ear 5A Coupler ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Coupler IEC 60318-5 2006 Tone Audiometer Tone Audiometer Tone Narrow Band Noise Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 ISO 389-2 1994 ISO 389-4 1994 Frequency RETSPL MaxHL...
  • Page 66 ANSI Free Field Free Field max SPL Free Field max HL is found by subtracting the ANSI S3.6-2010 selected RETSPL value Binaural Monaural Free Field Line 0° 45° 90° 0° 45° 90° Tone Frequency RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL Max SPL Max SPL 22.0...
  • Page 67 Survey of Reference and max Hearing Level Speech Audiometer. ANSI Speech ANSI TDH39 ANSI Ear 3A Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Speech Audiometer Speech Audiometer Speech Speech Noise Speech Speech Noise ANSI S3.6-2010...
  • Page 68 IEC Speech Calibration Ear 3A TDH39 Coupler IEC 60318-5 2006 Coupler IEC 60318-3 1998 (6ccm) Speech Audiometer Speech Audiometer Speech Speech Noise Speech Speech Noise IEC60645-2 1997 IEC60645-2 1997 IEC60645-2 1997 IEC60645-2 1997 RETSPL MaxHL RETSPL MaxHL RETSPL MaxHL RETSPL MaxHL Speech 20.0 20.0...
  • Page 69 Speech Calibration Sweden SWEDEN TDH39 SWEDEN EAR 3A Coupler IEC 60318-3 1998 (6ccm) Coupler IEC 60318-5 2006 Speech Audiometer Speech Audiometer Speech Speech Noise Speech Speech Noise STAF 1996 STAF 1996 STAF 1996 STAF 1996 RETSPL MaxHL RETSPL MaxHL RETSPL MaxHL RETSPL MaxHL Linear Type A 22.0 27.0...
  • Page 70 Speech Calibration Norway Norway TDH39 Coupler IEC 60318-3 1998 (6ccm) Norway EAR 3A Speech Audiometer Coupler IEC 60318-5 2006 Speech Speech Noise Speech Audiometer Norway Norway Speech Speech Noise RETSPL MaxHL RETSPL MaxHL Norway Norway Linear Type A 40.0 40.0 RETSPL MaxHL RETSPL MaxHL Equ.
  • Page 71 Equivalent Free Field Equivalent Free Field Speech Audiometer TDH39 HDA200 IEC60645-2 1997 ANSI S3.6-2010 ISO389-8 2004 IEC60318-3 1998 IEC60318-1 Frequency -17,5 -5,0 -14,5 -4,5 -12,0 -4,5 -9,5 -4,5 -6,5 -5,0 -3,5 -5,5 -5,0 -2,5 -2,5 -0,5 -3,0 1000 -0,5 -3,5 1250 -1,0 -2,0...
  • Page 72 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 73 Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard. Guidance and manufacturer’s declaration - electromagnetic emissions 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.
  • Page 74 Instrument Headset Interacoustics Headphones + Mic Sennheiser PC131 Callisto Couple Base with BTE Mic A Interacoustics 107635 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:...
  • Page 75 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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