Maico MI 24 Operation Manual
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Maico MI 24 Operation Manual

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Operation Manual
touchTymp
MI 24 and MI 34 Version

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  • Page 1 Operation Manual touchTymp MI 24 and MI 34 Version...

  • Page 3: Table Of Contents

    Operation Manual touchTymp MI 24 and MI 34 Version Table of Contents 1 Introduction ......................4 1.1 General ......................4 1.2 Intended Use Statement ..................4 1.3 Contraindications of Use ..................4 1.4 Essential Performance ..................5 1.5 Features and Benefits of the touchTymp ............5 1.6 Description ......................
  • Page 4 Copyright © 2018 MAICO Diagnostics All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO Diagnostics. The information in this publication is proprietary to MAICO Diagnostics.

  • Page 5: Introduction

    "MI 24" or "MI 34 ". This operation manual is meant to make it as easy as possible for the operator to become familiar with the operation and functions of the touchTymp when performing Immittance tests.

  • Page 6: Essential Performance

     RaceCar (all versions) It might appear that the touchTymp already contains licenses due to the version you ordered (e.g. if ordered touchTymp MI 24 version comes with a probe tone of 1000 Hz for Tympanometry and Acoustic Reflexes). NOTE: Each license key is specific for the serial number of your device.

  • Page 7: Description

    Operation Manual touchTymp MI 24 and MI 34 Version 1.5.3 Printing Options Printing test results from the touchTymp are accomplished in a variety of ways:  Use the build-in printer to directly print results.  Transfer touchTymp test data into the PC-software and print results on your PC-printer.
  • Page 8 Operation Manual touchTymp MI 24 and MI 34 Version 1.6.3 Acoustic Reflex An Acoustic Reflex, or contraction of the stapedial muscle, occurs under normal conditions when a sufficiently intense sound is presented to the auditory pathway. This contraction of the muscle causes a stiffening of the ossicular chain which changes the compliance of the middle ear system.

  • Page 9: For Your Safety

    2.1 How to Read this Operation Manual This Operation Manual contains information pertinent to the use of the MAICO device system including safety information as well as maintenance and cleaning recommendations.

  • Page 10: Customer Responsibility

    (see sections 3.2 and 3.3). Breach of the customer responsibility can lead to limitations of Manufacturer’s Liability and Warranty (see sections 2.3 and 3.1). NOTE: In the unlikely case of a serious incident, inform MAICO as well as your local distributor.

  • Page 11: Regulatory Symbols

    Operation Manual touchTymp MI 24 and MI 34 Version 2.4 Regulatory Symbols The following Table 1 gives an explanation of the symbols used on the device itself, on the packaging and the accompanying documents including the Operation Manual. Table 1 Regulatory Symbols...

  • Page 12: General Precautions

    Operation Manual touchTymp MI 24 and MI 34 Version 2.5 General Precautions Before starting a measurement make sure, that the device WARNING works properly. Use and store the device indoors only. For operation, storage and transport conditions see table in section 6.
  • Page 13 Operation Manual touchTymp MI 24 and MI 34 Version In case of emergency, disconnect the device from power supply. WARNING Do not position the device in a way that it is difficult to operate the disconnection device. The supply mains and In Case of Emergency the power socket shall be accessible at all times.

  • Page 14: Device Control

    Operation Manual touchTymp MI 24 and MI 34 Version In order to maintain a high level of safety and to ensure the CAUTION device works properly, it is necessary to have the device and its power supply checked according to the medical electrical safety standard IEC 60601-1 by a qualified service technician at least once a year.

  • Page 15: Warranty, Maintenance And After-Sales Service

    3.1 Warranty The MAICO device is guaranteed for at least one year. Ask your authorized local distributor for more information. This warranty is extended to the original purchaser of the device by MAICO through...
  • Page 16 Operation Manual touchTymp MI 24 and MI 34 Version Recommendations for cleaning and disinfection of MAICO device presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility.
  • Page 17 Operation Manual touchTymp MI 24 and MI 34 Version 3.3.4 Cleaning the Probe Tip In order to secure correct immittance measurements it is important to make sure that the probe system is kept clean at all times. Therefore please clean the probe on a periodic basis.

  • Page 18: Disposables

    Operation Manual touchTymp MI 24 and MI 34 Version Screw the probe cap back on the probe (Figure 7). The force of tightening the cap will tighten the screw sufficiently. Never use tools to fix the probe cap! If any blockage or damage occurs to the sealing gasket, the probe system can only be serviced by MAICO.

  • Page 19: Components/Replacement Parts

    In case of re-use of the single-use equipment you WARNING enhance the risk of cross contamination! MAICO strongly recommends to use Sanibel eartips only. In case you want to purchase further disposables, please contact MAICO or your local distributor. 3.5 Components/Replacement Parts Some reusable components are subject to wear with use over time.

  • Page 20: Recycling And Disposal

    Within the European Union it is illegal to dispose of electric and electronic waste as unsorted municipal waste. According to this, all MAICO products sold after August 13, 2005, are marked with a crossed-out wheeled bin. Within the limits of Article (9) of DIRECTIVE 2002/96/EC on waste electrical and electronic equipment (WEEE), MAICO has changed their sales policy.

  • Page 21: Unpacking And Installation

    Operation Manual touchTymp MI 24 and MI 34 Version 4 Unpacking and Installation This section provides information on:  unpacking the system  becoming familiar with the hardware inclusive connections  how to store the device  becoming familiar with the Pen Probe and the Shoulder Box ...
  • Page 22 Operation Manual touchTymp MI 24 and MI 34 Version The touchTymp comes with different components (see the following tables). The availability of configurations with the following components is country and version specific. Contact your local distributor for more information. Components...

  • Page 23: Hardware And Accessories

    Extra Licenses Tympanometry 1000 Hz RaceCar Disposables Supplied NOTE: MAICO strongly recommends to use Sanibel eartips for reliable results. Eartip Box Sanibel Blue, 7 mm Mushroom, Silicone Eartips (10 pcs.) Sanibel Green, 9 mm Mushroom, Silicone Eartips (10 pcs.) Sanibel Red, 3-5 mm Flanged, Silicone Eartips (10 pcs.) Sanibel Blue, 11 mm Mushroom, Silicone Eartips (10 pcs.)
  • Page 24 Operation Manual touchTymp MI 24 and MI 34 Version 4.2.2 Connections for Accessories, Power Supply and USB-Devices Figure 16 shows the connections on the backside of the device. The connections are explained in Table 3. Insert plugs with care into the appropriate connection. Do not wiggle the plug or pull with force while connected.
  • Page 25 Operation Manual touchTymp MI 24 and MI 34 Version 4.2.3 Connecting the Probe System Connect and disconnect the probe as follows: 1. To connect position the probe connector over the locating pins (Figure 17) 2. Push the connector until the clips lock-in (Figure 18, 1). If the clips haven 3.
  • Page 26 The Pen Probe is most suitable for screening since you can fit it on the patient with high sensitivity and is standard with MI 24 versions. The Shoulder Box allows hands free work while performing diagnostic measurements and is the standard probe for MI 34 versions.
  • Page 27 Operation Manual touchTymp MI 24 and MI 34 Version The Shoulder Box Use the clothing clip on the Shoulder Box to secure the probe to clothing or bedding and insert the probe gently into the ear of the subject. Figure 22...
  • Page 28 Operation Manual touchTymp MI 24 and MI 34 Version The Light Bar The light bar function on the probe allows the examiner to view test progression and final compliance for patient focused operation. It can be set on or off in the Basic settings menu (see section 5.6.3).
  • Page 29 Operation Manual touchTymp MI 24 and MI 34 Version 4.2.7 The Built-In Printer NOTE: This section only applies to touchTymp devices purchased with a built-in printer. In order to change paper rolls:  Push the marker on the left side of the touchTymp to open the printer cover (Figure 24).

  • Page 30: Operating The Device

    Operation Manual touchTymp MI 24 and MI 34 Version 5 Operating the Device This section offers you information about:  how to get started with the touchTymp  the main screen format and the home screen  performing immittance testing and audiometry testing ...

  • Page 31: Power-Saving Mode And Automatic Power-Off

    Operation Manual touchTymp MI 24 and MI 34 Version Important information or reminders may be displayed during the boot up process. This could include: Calibration Reminder: If a detected transducer is within one month of expiration of the calibration date, a reminder message (Figure 31) will appear (once per day).

  • Page 32: The Home Screen

    5.3 The Home Screen The Home screen displays the buttons controlling entry into the major functions of the touchTymp. These functions include the specific test selection for MI 24 version (Figure 34) and MI 34 version (Figure 35). To access the test, select the module from the Home screen (1) or Fixed Function Bar (2).
  • Page 33 Operation Manual touchTymp MI 24 and MI 34 Version The available icons for the Tool Bar include (Table 9): Table 9 Icons in the Tool Bar ICON FUNCTION EXPLANATION Delete Delete: to delete the stored measurements. Select the button and a message box will appear to confirm which test modules to delete or select all.
  • Page 34 Operation Manual touchTymp MI 24 and MI 34 Version Fixed Function Bar: This bar stays constant through device operation and the allowable test modules are based on the version purchased. The icons include (Table 10): Table 10 Icons in the Fixed Function Bar...
  • Page 35 Operation Manual touchTymp MI 24 and MI 34 Version  The aim of Acoustic Reflexes is to test the condition of the Musculus stapedius. o One or more louder tones will be heard during the test. No participation is expected from the patient.
  • Page 36 Operation Manual touchTymp MI 24 and MI 34 Version 5.4.3.5 Status Indicator The status indicator (Figure 40) in the middle of each test screen provides the probe status on the display screen. Figure 40 The same information is shown on the probe with the single LED (Table 11).
  • Page 37 Operation Manual touchTymp MI 24 and MI 34 Version Performing a measurement Choose the ear by pressing on the corresponding tympanogram, the ear buttons (Figure 42) or the Probe button. Figure 42 Choose the test frequency by pressing on the corresponding button.
  • Page 38 Operation Manual touchTymp MI 24 and MI 34 Version A normative box can be displayed for easier evaluation of the test result as a shaded area on the Tympanogram (Figure 45). The normative box is displayed based on US or International Standards as selected in the setting menu.
  • Page 39 Operation Manual touchTymp MI 24 and MI 34 Version Performing a measurement The screen (Figure 47) shows the buttons for Ipsi and Contra as well as the different frequency buttons. They are always presented according to the default settings in the setting menu and from low to high frequencies.
  • Page 40 Operation Manual touchTymp MI 24 and MI 34 Version At the conclusion of the test, the result symbol appears at the top right corner of the box either in the graphical view as in the table view. This is displayed for the Acoustic Reflex measurement that meets the criteria as defined in the setup menu.
  • Page 41 Operation Manual touchTymp MI 24 and MI 34 Version The stimulus selected upon entering the Edit screen is always the first reflex performed. A red or blue line will outline the selected box based on which ear is selected (Figure 52).
  • Page 42 Operation Manual touchTymp MI 24 and MI 34 Version 5.4.4.3 RaceCar Operation (Extra License) The RaceCar is an animation to provide a visual distraction while the test is being performed. The RaceCar goes through an animation series starting upon the seal of Tympanometry and continue through the finish line.
  • Page 43 Operation Manual touchTymp MI 24 and MI 34 Version Active Buttons within the RaceCar screen are:  Ear buttons: Select test ear or touch the Tympanometer graph (Tympanometry module only).  Play button: to start the test when manual operation is defined.
  • Page 44 Operation Manual touchTymp MI 24 and MI 34 Version Select the stimulus by pressing the small box on the right. A red or blue line will outline the selected box based on which ear is selected (Figure 62). NOTE: 1000 Hz is the default frequency when entering the Reflex Decay test screen.
  • Page 45 Operation Manual touchTymp MI 24 and MI 34 Version 5.4.4.5 Performance and Evaluation of Eustachian Tube Function (ETF) – MI 34 Version Selection of the ETF icon from the Home screen or Fixed Function Bar leads to the ETF screen (Figure 67). ETF has two operations: ...
  • Page 46 Operation Manual touchTymp MI 24 and MI 34 Version Compare the single tympanograms in the multilayered tympanogram (Figure 72). Tympanograms displayed include:  or Blue: represents test ear  represents “Swallow” Orange:  represents “Valsalva maneuver” Green: NOTE: The order of instructions displayed can be configured in the Settings, see section 5.6.13).
  • Page 47 Operation Manual touchTymp MI 24 and MI 34 Version 5.4.5 Managing Test Results 5.4.5.1 General There are different possibilities to manage the results. It is possible to print the session directly with the built-in printer or transfer the data to a PC for further processing.
  • Page 48 Operation Manual touchTymp MI 24 and MI 34 Version 5.4.5.5 Understanding the Print-Out (Built-In Printer) The print-out displays the following information (Figure 80 and Figure 81). MAICO logo and name of device Facility info: Prints automatically those fields that contain data (not shown if no data is entered).

  • Page 49: Settings

    Select the Settings button in the Fixed Function Bar to access the list of setting menus. MI 34 version offers two additional menus: Reflex Decay and ETF (MI 24 – Figure 84, MI 34 – Figure 85). MI 24...
  • Page 50 Operation Manual touchTymp MI 24 and MI 34 Version 5.6.2 Settings – Basic – General Figure 87 Start Screen: Adjust the start screen to your needs. Choose Tympanometry Tympanometry Acoustic Reflexes for upon boot-up the chosen screen is automatically entered (Figure 87).
  • Page 51 Operation Manual touchTymp MI 24 and MI 34 Version 5.6.3 Settings – Basic – Measurement Start measurement : Select Automatic if the measurement shall be started automatically as soon as the probe is placed in the ear properly. Select Manual if the test shall start by pressing the Play button or the Probe button (Figure 93).
  • Page 52 Operation Manual touchTymp MI 24 and MI 34 Version Set date: Set the current date using the date control (Figure 100). Figure 100 Time format: Select the preferred clock, using the 12 or 24 hour time format (Figure 101). Figure 101 Set time: Set the time by using the time control.
  • Page 53 Stop pressure: the end pressure of the tympanometry measurement (Figure 106). NOTE: MI 24 version, the start pressure must be a higher Figure 106 value than the stop pressure. MI 34 version, the start pressure can be higher or lower than the stop pressure.
  • Page 54 Operation Manual touchTymp MI 24 and MI 34 Version 678 Hz and 800 Hz allows for a User defined normative box only (MI 34 version only) (Figure 109). Figure 109 Display pass / no response: Activates a Pass No Response...
  • Page 55 Operation Manual touchTymp MI 24 and MI 34 Version For instance, when during the Tympanometry a 1.0 ml ear volume is measured, the intensity of the stimuli during the Acoustic Reflex measurement will be reduced by 6 dB, with AGC active this results in a more accurate reflex threshold measurement.
  • Page 56 Operation Manual touchTymp MI 24 and MI 34 Version for MI 34 version also include noise stimuli (BB – Broadband, HP – High Pass, LP – Low Pass). When options are greyed out in the settings screen, the license is not active (Figure 122).
  • Page 57 5.6.16 Settings – License Management – General The License Management screen allows additional feature/test operation to be incorporated into a base model by entering a license key. Contact MAICO or your local distributor for more information. The tab General contains a field to enter a new license code in order to activate the license on the device.
  • Page 58 Operation Manual touchTymp MI 24 and MI 34 Version 5.6.17 Settings – Service – General Calibration reminder: Annual calibration touchTymp and its transducers is recommended. Figure 134 Select or deselect this item to enable or disable a reminder that will display daily. The reminder starts 1 month prior to the expiration of the calibration date for your acoustic transducer(s) (Figure 134).
  • Page 59 Operation Manual touchTymp MI 24 and MI 34 Version 5.6.18 Settings – Service – About On this screen the most important device information are presented. Additionally, the Qt License Agreement is shown (Figure 148). Figure 148 5.6.19 Settings –Service – Support This menu is only for editing by service.

  • Page 60: Technical Data

    General Information About Specifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year. MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies. STANDARDS...
  • Page 61 Operation Manual touchTymp MI 24 and MI 34 Version Environmental Operation: +15 °C to +35 °C / conditions: + 59 °F to +95 °F Relative humidity 30 % to 90 % (non-condensing) Air pressure 98 kPa to 104 kPa Maximum altitude: 2000 m / 6561 ft above sea level...
  • Page 62 Operation Manual touchTymp MI 24 and MI 34 Version TYMPANOMETRY Test signals: Pure tone: 226 Hz, 1000 Hz each with ± 1 % Additional for MI 34: 678 Hz, 800 Hz each with 1 % Test level: 85 dB SPL ±1.5 dB SPL measured in an IEC 60318-5 acoustic coupler according to IEC 60645-5:2004 / ANSI S3.39:1987.
  • Page 63 Operation Manual touchTymp MI 24 and MI 34 Version ACOUSTIC REFLEXES Test methods: Ipsilateral and Contralateral Test signals: Pure Tones: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz each with ±1 % Noise (MI 34): Broadband, High Pass, Low Pass...

  • Page 64: Connections

    Operation Manual touchTymp MI 24 and MI 34 Version REFLEX CALIBRATION STANDARDS AND SPECTRAL PROPERTIES General Specifications for stimulus and audiometer signals are made to follow IEC 60645-5/ANSI S3.39. Ipsilateral Earphone: Pure Tone: MAICO Standard Values Contralateral Earphone: Pure Tone: ISO 389-2 for CIR22/CIR55.

  • Page 65: Pin Assignment

    Operation Manual touchTymp MI 24 and MI 34 Version 6.3 Pin Assignment Table 16 Pin Assignment SOCKET CONNECTOR PIN 1 PIN 2 PIN 3 Mains DC socket 24 V/2,5 A Contra Phone L Ground Signal Phone R Bone 6.3 mm Mono...

  • Page 66: Calibration Values

    Operation Manual touchTymp MI 24 and MI 34 Version 6.4 Calibration Values COUPLER TYPES USED BY CALIBRATION IOW Probe (probe Calibrated using a IEC 60318-5 (2cc) acoustic coupler made system): in accordance to MAICO Standard Values IP30 Calibrated using a IEC 60318-5 (2cc) acoustic coupler made...

  • Page 67: Electromagnetic Compatibility (Emc)

    If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by MAICO as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
  • Page 68 Operation Manual touchTymp MI 24 and MI 34 Version Guidance and manufacturer’s declaration — electromagnetic immunity The touchTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the touchTymp should assure that it is used in such an environment, Electromagnetic environment –...

  • Page 69: Electrical Safety, Emc And Associated Standards

    Operation Manual touchTymp MI 24 and MI 34 Version 6.6 Electrical Safety, EMC and Associated Standards 1. IEC 60601-1:2012/ ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1 General Requirements for Safety 2. CAN/CSA-C22.2 No. 60601-1:2008: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 3.

  • Page 70: Appendix A Literature

    Operation Manual touchTymp MI 24 and MI 34 Version Appendix A Literature L. Macedo de Resende; J. dos Santos Ferreira; S. Alves da Silva Carvalho; I. Oliveira; I. Barreto Bassi, „Tympanometry with 226 and 1000 Hertz tone probes in infants” Braz.
  • Page 71 Specifications are subject to change without notice. MAICO Diagnostics GmbH Sickingenstr. 70-71 10553 Berlin Germany Tel.: + 49 30 / 70 71 46-50 Fax: + 49 30 / 70 71 46-99 E-mail: sales@maico.biz Internet: www.maico.biz...

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