Interacoustics Callisto AC440 Instructions For Use Manual

Interacoustics Callisto AC440 Instructions For Use Manual

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Instructions for Use – US
Callisto™

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Summary of Contents for Interacoustics Callisto AC440

  • Page 1 Science made smarter Instructions for Use – US Callisto™...
  • Page 3: Table Of Contents

    HIT440 software - Technical specifications ..............55 Using the print wizard ........................56 MAINTENANCE ..........................59 General maintenance procedures ....................59 How to clean Interacoustics products ..................59 Concerning repair ........................60 Warranty ............................60 GENERAL TECHNICAL SPECIFICATIONS ................. 61 Reference equivalent threshold values for transducers and maximum hearing level settings provided at each test frequency ....................
  • Page 5: Introduction

    1. Introduction 1.1 About this manual This manual is valid for the Callisto™. The product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: info@interacoustics.com Web: www.interacoustics.com 1.2 Intended use The Callisto™...
  • Page 6: Included And Optional Parts And Accessories

    1.4 Included and optional parts and accessories AC440 REM440 HIT440 Standard Parts Standard Parts Standard Parts: • IHM60 In-situ Headset DD45 Audiometric TBS10 Test Box • • (kit) Headset • Coupler Box • Probe Tubes 36 pcs 2cc coupler • MTH400m Monitor SP70 Loudspeaker + Wire •...
  • Page 7: Warnings And Precautions

    Do not touch the patient while operating PC, printer etc. No modification of this equipment is allowed without Interacoustics authorization. Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service personnel to repair those parts of this.
  • Page 8 - exchange of transducers requires a new calibration. Interacoustics will not make any guarantee 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 9 Interacoustics A/S cannot be held liable for your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsoft.
  • Page 10 D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 6...
  • Page 11: Unpacking And Installation

    2. Unpacking and installation 2.1 Unpacking and inspection Check box and contents for damage When the instrument is received please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically.
  • Page 12: Callisto™ - Connection Panel Dictionary

    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 Socket for talk forward or microphone Monitor Socket for monitor headset Socket for free field speaker Bone Socket for bone conductor...
  • Page 13: 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 14: Software Installation Windows®7 And Windows®8

    2.5.1 Software installation Windows®7 and Windows®8 Callisto ™ Suite Insert the installation USB drive and follow the steps below to install the software. To find the installation file; click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB.
  • Page 15 Should you wish to install the software to a different location than the default then please click on ’Options’ ahead of ’Install’ D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 11...
  • Page 16 2. Depending on your Windows User Account settings the following dialog may appear. Select “Yes” to continue the installation. Please wait while the Callisto™ Suite is being installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 12...
  • Page 17 When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Callisto™ Suite is now installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 13...
  • Page 18: Software Installation Windows®8.1

    2.5.2 Software installation Windows®8.1 Callisto TM Suite Insert the installation USB drive and follow the steps below to install the software. To find the installation file; click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB.
  • Page 19 Should you wish to install the software to a different location than the default then please click on ’Options’ ahead of ’Install’ D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 15...
  • Page 20 Depending on your Windows User Account settings the following dialog may appear. Select “Yes” to continue with the installation. Please wait while the Callisto™ Suite is being installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 16...
  • Page 21 When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Callisto™ Suite is now installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 17...
  • Page 22: Software Installation Windows®10

    2.5.3 Software installation Windows®10 Callisto TM Suite Insert the installation USB drive and follow the steps below to install the software. To find the installation file; click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB.
  • Page 23 Should you wish to install the software to a different location than the default then please click on ’Options’ ahead of ’Install’ D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 19...
  • Page 24 Depending on your Windows User Account settings the following dialog may appear. Select “Yes” to continue with the installation. Please wait while the Callisto™ Suite is being installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 20...
  • Page 25 When the installation is complete, the dialog box below is shown. Click “Close” to finish the installation. The Callisto™ Suite is now installed. D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 21...
  • Page 26: Driver Installation

    2.6 Driver installation Now that the Callisto™ Suite software is installed, you must install the driver for 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 for use.
  • Page 27: Sound Device Settings For Windows®7/ Windows®8/Windows®10

    2.6.2 Sound device settings for Windows®7/ Windows®8/Windows®10 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. In the “Recording”...
  • Page 28: Using With Databases

    The Callisto™ Suite has a backup location for data to be written in the case that the software is accidentally terminated or the system crashes. The following location is the default storage folder C:\ProgramData\Interacoustics\Callisto Suite\, however this can be changed by following the below instructions.
  • Page 29: About Callisto Suite

    2.11 About Callisto Suite Should you go to Menu > Help > About then you will see the below window. This is the area of the software where you can manage license keys and check your Suite, Firmware and Build Versions. Also in this window you will find the Checksum section which is a feature designed to help you identify the integrity of the software.
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  • Page 31: 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 following general precautions: 1.
  • Page 32: Ac440 Using The Tone Screen Elements

    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 & New Session saves the current session in Noah or OtoAccess® and opens a new one.
  • Page 33 Fold an area so that it only shows the label or the buttons of that area. Unfold an area so that all buttons and labels are visible. Show/hide areas can be found by right mouse clicking on one of the areas.
  • Page 34 Edit Mode button activates the editing function. Left clicking on the graph will add/move a point to the position of the cursor. If right clicking on a specific stored point a context menu appears offering you the following options: Mouse controlled audiometry enables you to do the audiometry using the mouse only.
  • Page 35 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 36 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. Masking indicates if channel 2 is currently in use as a masking channel and in that way makes sure masking symbols are used in the audiogram.
  • Page 37 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 search for the hardware. If it does not detect the hardware then the system will automatically continue in simulation mode and the Simulation icon (left) will show in place of the connected hardware indication picture.
  • Page 38: Using The Speech Screen

    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. WR1, WR2, WR3 (Word Recognition) toggles between different speech lists if selected in the AC440 setup.
  • Page 39 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. Note that the background shading is according to the side that is selected, red for right and blue for left.
  • Page 40: Speech Audiometry In Graph Mode

    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. 1) The graph: The curves of the recorded speech graph will be displayed on your screen. The x-axis shows the intensity of the speech signal and the y-axis shows the score in percent.
  • Page 41: Speech Audiometry In Table Mode

    3.2.2 Speech audiometry in table mode The AC440 Table Mode consists of two tables: The SRT (Speech Reception Threshold) table. When the SRT test is active, it is indicated in orange The WR (Word Recognition) table. When WR1, WR2, or WR3 is active the corresponding label will be orange The SRT table The SRT table (Speech Reception Threshold table) allows for measuring multiple SRTs using different test...
  • Page 42 The WR table The word recognition (WR) table allows for measuring multiple WR scores using different parameters (e.g. Transducer, Test Type, Intensity, Masking, and Aided). Upon changing Transducer, Masking, and/or Aided re-testing an additional WR entry will appear in the WR table.
  • Page 43: Pc Keyboard Shortcuts Manager

    PC keyboard shortcuts manager 3.2.3 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.) To personalize a shortcut, click on the column in the middle and add the custom shortcut in the field on the right hand of the screen...
  • Page 44: Technical Specifications Of The Ac440 Software

    3.2.4 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 45 Signal Indicator (VU) Time weighting: 350mS Dynamic range: -20dB to +3dB Rectifier characteristics: Selectable inputs are provide with an attenuator by which the level can be adjusted to the indicator reference position(0dB) Storing capability Tone audiogram: dB HL, MCL, UCL, Tinnitus, R+L Speech Audiogram: WR1, WR2, WR3, MCL, UCL, Aided, Unaided, Binaural.
  • Page 46: Rem440 Screen Elements

    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 47 (at midnight). Note: these timeframes are limited by HIMSA and the Noah software, and not by Interacoustics. Single Frequency button is a test that lets the fitter play a single frequency warble tone. Once clicked, the exact frequency, input and output can be seen on the graph.
  • Page 48 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. Whilst adjusting the gain handles in the fitting software, the REM440 screen will at all times stay on top of the fitting screen allowing for easy curve comparison.
  • Page 49 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. Normal and Reversed Coordinate System buttons enable you to toggle between reversed and normal graph displays.
  • Page 50 1. Connect a monitor headset to the monitor output on the hardware. It is recommended to use only a monitor headset which is approved by Interacoustics. 2. Tick the Monitor check box. 3. Use the slider to turn the sound level up and down.
  • Page 51 The Graph shows measured REM curves. The X axis shows the frequency and the Y axis shows the intensity of the test signal. Gain/Response View allows for toggling between viewing the curve as a gain or response curve. Note that this option is not active for REIG . Measurement Type is indicated above the graph together with a right/left indication.
  • Page 52 Hardware indication picture: The picture indicates whether the hardware is connected. When opening the Suite the system will search for 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 left).
  • Page 53: Rem Software - Technical Specifications

    3.3.1 REM 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. Real Ear Measurement IEC 61669, ANSI S3.46.
  • Page 54: The Hit440 Screen

    3.4 The HIT440 screen The following section describes the elements of the HIT screen. Menu provides access to Print, Edit, View, Mode, Setup, and Help. Print button allows you to print only the test results currently displayed on the screen. To print multiple tests on one page, select Print then Print Layout Save &...
  • Page 55 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 56 Show curser on graph provides information about each specific measured point in the curve. The curser is “locked” to the curve and a frequency and intensity label will be displayed at the curser’s position, as illustrated below: Stimulus Selection allows for selecting a test stimulus. The dropdown is only present for custom made test protocols.
  • Page 57 Current Protocol is listed in the lower left hand corner. indicates the test is a part of an automatic test flow (Auto Run). When pressing START all tests with the tick mark will be performed. If you wish to perform one test only, mark it using the mouse by clicking on it.
  • Page 58 Measurement details: In this table the curve details can always be viewed. This way the professional always has an overview of what is being measured. Read information such as Input Level, Max SPL, Curve Type, Stimulus, and Curve type. A Curve Comment for each curve can be typed into the comment section on the right hand side.
  • Page 59: 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 – identification no. 0123. Hearing Aid Analyzer IEC 60118-0, IEC 60118-7, ANSI S3.22.
  • Page 60: Using The Print Wizard

    3.5 Using the print wizard In the Print Wizard you have the option to create customized print templates which can be linked to individual protocols for quick printing. The Print Wizard can be reached in two ways. a. If you want to use a template for general use, or select an existing one for printing: Go to Menu/ Print/Print layout…...
  • Page 61 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 D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US...
  • Page 62 D-0101246-M – 2020/05 Callisto™ - Instructions for Use - US Page 58...
  • Page 63: Maintenance

    • 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. To ensure that the reliability of the instrument is kept, it is recommended that the operator at short •...
  • Page 64: Concerning Repair

    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 65: 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 67 Callisto RETSPL-HL Tabel 5.1 Survey of Reference and max Hearing Level Tone Audiometer Pure Tone RETSPL Transducer DD45 TDH39 DD65V2 HDA200 HDA300 EAR3A IP30 EAR5A Impedance 10 Ω 10 Ω 10 Ω 40 Ω 23 Ω 10 Ω 10 Ω 10 Ω...
  • Page 68 Callisto RETSPL-HL Tabel Pure Tone max HL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear...
  • Page 69 Callisto RETSPL-HL Tabel NB noise effective masking level Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear...
  • Page 70 Callisto RETSPL-HL Tabel NB noise max HL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear...
  • Page 71 Callisto RETSPL-HL Tabel ANSI Speech RETSPL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear 2ccm...
  • Page 72 Callisto RETSPL-HL Tabel IEC Speech RETSPL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear 2ccm...
  • Page 73 Callisto RETSPL-HL Tabel Sweden Speech RETSPL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear 2ccm...
  • Page 74 Callisto RETSPL-HL Tabel Norway Speech RETSPL Transducer DD45 TDH39 DD65V2 HDA200 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 Artificial ear Artificial ear 2ccm...
  • Page 75 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 Artificial ear Artificial ear 2ccm...
  • Page 76 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 Artificial ear Artificial ear 2ccm...
  • Page 77 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 RETSPL RETSPL RETSPL...
  • Page 78 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 Free Field Power Binaural Monaural 0° - 45° - 90° 0° 45° 90° correction Max SPL RETSPL RETSPL...
  • Page 79 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 Free Field Power Binaural Monaural 0° - 45° - 90° 0° 45° 90° correction Max SPL RETSPL...
  • Page 80 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 12.8...
  • Page 81 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 Ground DC bias REF-mic.
  • Page 83 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 84 The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
  • Page 85 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 Compliance Electromagnetic level...
  • Page 86 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 Compliance level Electromagnetic test level...
  • Page 87 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 89 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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