Maico touchTymp MI 26 Operation Manual
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Maico touchTymp MI 26 Operation Manual

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Operation Manual
touchTymp
MI 26 and MI 36 Version

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Summary of Contents for Maico touchTymp MI 26

  • Page 1 Operation Manual touchTymp MI 26 and MI 36 Version...

  • Page 3: Table Of Contents

    Operation Manual touchTymp MI 26 and MI 36 Version Table of Contents 1 Introduction ......................4 1.1 General ......................4 1.2 Intended Use Statement ..................4 1.3 Contraindications of Use ..................5 1.4 Features and Benefits of the touchTymp ............5 1.5 Description ......................
  • Page 4 Copyright © 2021 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

    1.1 General This operation manual is for the touchTymp MI 26 and MI 36 versions. If sections or parts of sections of this operation manual apply only to certain versions of the device, they are marked with "MI 26" or "MI 36 ". 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: Contraindications Of Use

    Operation Manual touchTymp MI 26 and MI 36 Version 1.3 Contraindications of Use Tympanometry and Acoustical Reflex testing should not be performed on patients with one of the following symptoms without a medical doctor’s approval: • Recent stapedectomy or other middle ear surgery •...

  • Page 7: Description

    • PC Connection (all versions, for connection with MAICO Sessions) It might appear that the touchTymp already contains licenses due to the version you ordered (e.g. if ordered touchTymp MI 26 version comes with a probe tone of 1000 Hz for Tympanometry and Acoustic Reflexes).
  • Page 8 Operation Manual touchTymp MI 26 and MI 36 Version the air pressure is varied automatically from a positive value (i.e. +200 daPa) to a negative value (i.e. -400 daPa max). Figure 1 Maximum compliance of the middle ear system occurs, when the pressure in the middle ear cavity is equal to the pressure in the external auditory canal.
  • Page 9 Operation Manual touchTymp MI 26 and MI 36 Version 1.5.4 Acoustic Reflex Decay (MI 36 Version Only) Acoustic reflex decay, also known as adaptation, is the measurement of the acoustic reflex response during sustained stimulus presentation. Ipsilateral and Contralateral Reflex Decay can be performed.

  • Page 10: 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 11: 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 the competent authority in the country where the user is established.

  • Page 12: Regulatory Symbols

    Operation Manual touchTymp MI 26 and MI 36 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 13: General Precautions

    Operation Manual touchTymp MI 26 and MI 36 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 14 Operation Manual touchTymp MI 26 and MI 36 Version In case of emergency, disconnect the device from power supply. WARNING Position the device in such a way that it can be easily disconnected from the power plug at any time.

  • Page 15: Device Control

    Operation Manual touchTymp MI 26 and MI 36 Version The device is not intended for operation in areas with an WARNING explosion hazard. Do NOT use the device in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc. If the device is not used switch it off and disconnect it from the power supply.

  • Page 16: 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 17 Use a lens cleaning or microfiber cloth to clean the touchTymp touchscreen. 3.3.3 Cleaning the Case and Cables Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 8/8 Cleaning - YouTube https://www.youtube.com/watch?v=9o3QkyGCNLg&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbA G&index=8 Use caution while cleaning.
  • Page 18 Operation Manual touchTymp MI 26 and MI 36 Version 3.3.4 Cleaning the Probe Tip Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 7/8 Cleaning the probe - YouTube https://www.youtube.com/watch?v=r7Wj5wDFQDg&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbA G&index=7 In order to secure correct immittance measurements it is important to make sure that the probe system is kept clean at all times.
  • Page 19 Operation Manual touchTymp MI 26 and MI 36 Version Place the probe tip back onto the probe. Make sure that the plastic pegs are inserted into the appropriate corresponding cavities (Figure 6). Figure 6 Screw the probe cap back on the probe (Figure 7). The force of tightening the cap will tighten the screw sufficiently.

  • Page 20: Disposables

    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 21: 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 22: Unpacking And Installation

    Operation Manual touchTymp MI 26 and MI 36 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 23 Operation Manual touchTymp MI 26 and MI 36 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 24 Audiometry – Bone Conduction (Includes Masking) Extra Licenses Tympanometry 1000 Hz RaceCar PC Connection Disposables Supplied NOTE: MAICO strongly recommends to use Sanibel eartips for reliable results. Eartip Box Samples of Sanibel ear tips Probe Tip Probe Cleaning Tool Eartip Removal Tool Allen key SW: s = 2 mm (see section 4.2.9)

  • Page 25: Hardware Orientation

    Operation Manual touchTymp MI 26 and MI 36 Version 4.2 Hardware Orientation 4.2.1 Display The display on the touchTymp is a touch screen (Figure 15). This design feature allows use while wearing latex gloves. A rubber-tipped stylus can also be used to select the desired function on the screen.
  • Page 26 Operation Manual touchTymp MI 26 and MI 36 Version 4.2.3 Connecting the Probe System Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 1/8 Setup - YouTube https://www.youtube.com/watch?app=desktop&v=Hawp43VS3_Y&l ist=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbAG Connect and disconnect the probe as follows: 1. To connect position the probe connector over the locating pins (Figure 17) 2.
  • Page 27 Operation Manual touchTymp MI 26 and MI 36 Version 4.2.4 Establishing a PC-Connection To transfer data to a PC, establishing a PC-connection via USB is required. If the touchTymp is used with office equipment that is not a medical device itself (see Table 4), make sure to establish the PC-connection in one of the following ways (see Table 4, PC Connection 2, 3 or 4).
  • Page 28 Operation Manual touchTymp MI 26 and MI 36 Version 4.2.6 The Probes There are two probes available for the touchTymp, Pen Probe and Shoulder Box. The main functionalities are the same. The Pen Probe is most suitable for screening since you can fit it on the patient with high sensitivity and is standard with MI 26 versions.
  • Page 29 Operation Manual touchTymp MI 26 and MI 36 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 30 Operation Manual touchTymp MI 26 and MI 36 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 31 Operation Manual touchTymp MI 26 and MI 36 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 32: Operating The Device

    Operation Manual touchTymp MI 26 and MI 36 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 33: Power-Saving Mode And Automatic Power-Off

    Operation Manual touchTymp MI 26 and MI 36 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 34: The Home Screen

    Tool Bar Main Screen Display Fixed Function Bar Figure 36 Status Bar: displays the Date/Time and the status of PC-connection (highlighted green if connected to PC-software (PC license must be activated) and MAICO Sessions is running). 8511780 Rev. 4 30/06/2021...
  • Page 35 Operation Manual touchTymp MI 26 and MI 36 Version Tool Bar: A row of icons that activate key functions when selected. Some buttons in the toolbar will be ghosted when not useable. These buttons will change based on test or setting screen visible.
  • Page 36 5.4.3 Preparing for Testing – Immittance 5.4.3.1 Preparing the Patient Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 2/8 Test environment - YouTube https://www.youtube.com/watch?v=uY4jkbMc10c&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbAG &index=2 Make sure that the patient is comfortable on a chair or on an examination table if necessary.
  • Page 37 Operation Manual touchTymp MI 26 and MI 36 Version 5.4.3.3 Immittance Measurements Show the probe to the patient and then explain the following: • An eartip is placed on the tip of the probe and inserted into the ear canal. A seal must be achieved for the test to progress.
  • Page 38 Operation Manual touchTymp MI 26 and MI 36 Version 5.4.3.4 Handling the Eartips Choose the proper size of eartips based on your inspection of the size of the patient’s ear canals. Do not insert the probe without having an eartip attached to WARNING prevent damage to the patient’s ear canals.
  • Page 39 Operation Manual touchTymp MI 26 and MI 36 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 40 Operation Manual touchTymp MI 26 and MI 36 Version Performing a measurement Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 3/8 Tympanometry - YouTube https://www.youtube.com/watch?v=EMcGlihc_Aw&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbAG &index=3 Choose the ear by pressing on the corresponding tympanogram, the ear buttons (Figure 42) or the Probe button.
  • Page 41 Response (NR) signs will not be displayed. Normative Data / Pass and No Response Criteria Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 4/8 Test result - YouTube https://www.youtube.com/watch?v=jdXFM2_S3Dg&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbAG &index=4 If switched on, the normative boxes can be shown for 226 Hz and 1000 Hz. The box indicates the normative area where the peak of the Tympanogram is expected.
  • Page 42 Evaluation Also, check-out our training videos: MAICO Training | touchTymp Part 1 | 6/8 Acoustic reflex result - YouTube https://www.youtube.com/watch?v=FbQ5Zk1SGdM&list=PLonI5JzuDcd7lxKobEy7BW3DS59QCsbA G&index=6 The evaluation of the Acoustic Reflex test results depends on the configuration displayed as a graph or table.
  • Page 43 Operation Manual touchTymp MI 26 and MI 36 Version Table: The measured intensity level in dB HL is displayed simultaneously to the ongoing test. Underneath each diagram the frequency is displayed (Figure 49). Figure 49 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.
  • Page 44 Operation Manual touchTymp MI 26 and MI 36 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 45 Operation Manual touchTymp MI 26 and MI 36 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 46 Operation Manual touchTymp MI 26 and MI 36 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 47 Operation Manual touchTymp MI 26 and MI 36 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 48 Operation Manual touchTymp MI 26 and MI 36 Version 5.4.4.5 Performance and Evaluation of Eustachian Tube Function (ETF) – MI 36 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 49 Operation Manual touchTymp MI 26 and MI 36 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 50 Operation Manual touchTymp MI 26 and MI 36 Version 5.4.5 Managing Test Results – Immittance 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 51 Figure 81 5.4.5.6 Transferring Test Results to PC Note: For data transfer between touchTymp and MAICO Sessions it is necessary to activate the license for PC connection which can be additionally purchased. Before transferring data to a PC make sure that you have installed the PC software properly according to the separately delivered operation manual.

  • Page 52: Audiometry Testing

    Operation Manual touchTymp MI 26 and MI 36 Version 5.5 Audiometry Testing 5.5.1 General – Audiometry The following sections 5.5.2 to 5.5.5 offer information about testing with the Audiometry module. 5.5.2 The Screen Format – Audiometry The appearance of the Audiometry screen depends on the purchased device version (MI 26 Air Conduction only –...
  • Page 53 Operation Manual touchTymp MI 26 and MI 36 Version ICON FUNCTION EXPLANATION Home Home (only for Audiometry test screen): to return to the Home screen for test selection. Default Default: to set the device back to factory settings. Save Save: to save current selection.
  • Page 54 Operation Manual touchTymp MI 26 and MI 36 Version Table 13 Explanation of Main Audiometry Screen – Versions MI 26 with Bone Conduction and MI 36 Name(s) / Description Function(s) Hearing Level Turns the volume/level of the tone up/down. Present The function of Present is determined by the Test mode of the device.
  • Page 55 Operation Manual touchTymp MI 26 and MI 36 Version Name(s) / Description Function(s) Microphones Selection allows microphone changes when accessories are connected. 1. Talk Forward: Allows tester to provide instruction to the patient while the headphones are in place. Increase/decrease the volume by selecting the +/- (Figure 87).
  • Page 56 Operation Manual touchTymp MI 26 and MI 36 Version Name(s) / Description Function(s) Status Bar The numerical display for the testing operation of the device (Figure 88). Figure 88 The information includes (Table 14): Table 14 Status Bar explanation Status Bar Explanation When a stimulus is presented to the patient the small box on the edge of the bar turns green.
  • Page 57 Operation Manual touchTymp MI 26 and MI 36 Version Audiometry Main Screen Display (MI 26 with Air Conduction only) Figure 89 shows the Main Screen Display for MI 26 Air Conduction only. Table 15 gives further explanation. Figure 89 Table 15 Explanation of the Audiometry Main Screen Display (MI 26 – Air Conduction Only)
  • Page 58 Operation Manual touchTymp MI 26 and MI 36 Version Name(s) / Description Function (s) Selection allows two microphone changes when accessories are Micro- connected. phones 1. Talk Forward: Allows tester to provide instruction to the patient while the headphones are in place. Increase/decrease the volume by selecting the +/- (Figure 90).
  • Page 59 Operation Manual touchTymp MI 26 and MI 36 Version Name(s) / Description Function (s) Status Bar The numerical display for the testing operation of the device (Figure 88). Figure 91 The information includes (Table 14): Table 16 Status Bar explanation...
  • Page 60 Operation Manual touchTymp MI 26 and MI 36 Version 5.5.3.2 Placement of Headphones (for Testing with Headphones) Eliminate any obstructions which will interfere with the placement of the earphone cushions on the ear (i.e. hair, eyeglasses). Ensure that the headphones are positioned correctly: red phone on the right ear, blue phone on the left ear.
  • Page 61 Operation Manual touchTymp MI 26 and MI 36 Version 5.5.4.2 Bone Conduction Testing (MI 26 Version – Extra License, MI 36 Version – Included) Place the bone conduction oscillator on the patient’s head so that the flat, circular side of the transducer is placed on the mastoid, at the noticeable ledge of the cranial bone behind, but not touching the pinna.
  • Page 62 Operation Manual touchTymp MI 26 and MI 36 Version 5.5.5.3 Deleting Test Results Results are deleted by the Delete button or turning-off the device. When Delete is selected, each module is listed to confirm deletion (Figure 95). Figure 95 NOTE: It is best practice to delete results when patient testing is complete.

  • Page 63: Settings

    Operation Manual touchTymp MI 26 and MI 36 Version 5.5.5.6 Transferring Test Results to PC Before transferring data to a PC make sure that you have installed the PC software properly according to the separately delivered operation manual. Before establishing the PC connection you will have to consider the recommendations given in section 4.2.4 in case the touchTymp is connected to a non-medical device.
  • Page 64 Operation Manual touchTymp MI 26 and MI 36 Version Each menu consists of one or more tabs. Each tab contains one or more settings (Figure 99). When a tab is greyed out, it is not available due to a license must be purchased.
  • Page 65 Operation Manual touchTymp MI 26 and MI 36 Version Standby: Set the period of inactivity, after which the display will turn off. Pressing the screen or the Front key will awaken the device (Figure 103). Figure 103 NOTE: It is possible to turn off this function by setting the value to “never”.
  • Page 66 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.4 Settings – Basic – Print Automatic printout (Immittance): An automatic printout is directly generated upon the return of the probe into the probe holder when Probe into holder is selected (Figure 110).
  • Page 67 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.6 Settings – Basic – Facility Facility: Enter Facility information. The information entered in these fields will be shown on the printout when active. Empty fields will not be printed (Figure 116).
  • Page 68 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.8 Settings – Tympanometry – Probe Tone 226 Hz/1000 Hz (MI 36 Version Only: 678 Hz/800 Hz) The following explanations are for the tabs Probe tone 226 Hz (Figure 120) as well as Probe tone 1000 Hz (Figure 121).
  • Page 69 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.9 Settings – Acoustic Reflexes – General Presentation: Defines the Acoustic Reflex screen to start in graphical or table format (Figure 124). The selection here will also define the presentation on the print-out.
  • Page 70 Operation Manual touchTymp MI 26 and MI 36 Version In general, AGC is used to hold the level of the tone constant. Especially in smaller ear canal volumes AGC provides an accurate and safe intensity reflex stimulation. Without AGC, the reflex activator stimuli in these smaller ear canals would be higher than the referenced calibration value.
  • Page 71 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.12 Settings – Decay – General (MI 36 Version) Duration: Defines the length the tone will be presented to the patient (Figure 136). Duration can be configured in by 5 second increments from 10 s to 30 s.
  • Page 72 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.14 Settings – ETF – Perforated (MI 36 Version) Start pressure: the pressure that is first introduced when performing ETF – Perforated measurement (Figure 142). This is a default setting and can be configured Figure 142 within the test screen.
  • Page 73 Operation Manual touchTymp MI 26 and MI 36 Version Monitor phone: Allows audible presentation through the Monitor phone of the device (Figure 150). These signals include: • Button touch: A click sound is delivered to the monitor phone. Figure 150 •...
  • Page 74 Operation Manual touchTymp MI 26 and MI 36 Version • One audiogram: The test screen display one audiogram where standard audiometric symbols are plotted within the same graph based on earside, transducer and level at the time of selecting Store (Figure 154).
  • Page 75 Operation Manual touchTymp MI 26 and MI 36 Version • Increase top: + is in the top position and – is in bottom (usual setting for Display type None and Table) • Increase bottom: - is in the top position and + is in...
  • Page 76 Operation Manual touchTymp MI 26 and MI 36 Version Air: Select frequencies that are active during the air conduction test. Device only cycles through active frequencies in the test screen. 1000 Hz is not available for deselection and excluded from the list. Choose between: 125 Hz, 250 Hz, 500 Hz, 750 Hz, 1500 Hz, 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz, and 8000 Hz (Figure 163).
  • Page 77 5.6.19 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 78 Operation Manual touchTymp MI 26 and MI 36 Version Export error log: If an error is occurring you can export the error log data onto a USB flash drive (Figure 178). If there is no USB flash drive connected the message box Figure 178 (Figure 179) will be shown with further information.
  • Page 79 Operation Manual touchTymp MI 26 and MI 36 Version 5.6.22 Settings –Service – Support This menu is only for editing by service. The dealer can enter his contact information to display in the Quick Info screen (Figure 187). Figure 187 5.6.23 Quick Info...

  • Page 80: 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 every 12 months. MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies. STANDARDS...
  • Page 81 Operation Manual touchTymp MI 26 and MI 36 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 82 Operation Manual touchTymp MI 26 and MI 36 Version TYMPANOMETRY Test signals: Pure tone: 226 Hz, 1000 Hz each with ± 1 % Additional for MI 36: 678 Hz, 800 Hz each with 1 % (continuous tones) 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 83 Operation Manual touchTymp MI 26 and MI 36 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 36): Broadband, High Pass, Low Pass...
  • Page 84 Operation Manual touchTymp MI 26 and MI 36 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 Pure Tone: ISO 389-2 for IP 30...

  • Page 85: Connections

    Operation Manual touchTymp MI 26 and MI 36 Version 6.2 Connections 10 11 12 Figure 189 Table 18 Connections on Backside of Device CONNECTIONS No. Connection Specification socket Ethernet Not applicable in actual version USB out 2 x USB 1.1 USB in USB 1.1...

  • Page 86: Pin Assignment

    Operation Manual touchTymp MI 26 and MI 36 Version 6.3 Pin Assignment Table 19 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 87: Calibration Values And Maximum Levels

    Operation Manual touchTymp MI 26 and MI 36 Version 6.4 Calibration Values and Maximum Levels 6.4.1 Calibration Values and Maximum Levels – Immittance COUPLER TYPES USED BY CALIBRATION IOWA Probe (probe Calibrated using a IEC 60318-5 (2cc) acoustic coupler made...
  • Page 88 Operation Manual touchTymp MI 26 and MI 36 Version 6.4.2 Calibration Values and Maximum Levels – Audiometry Calibration Values and Max Levels: Headphone DD45 Coupler IEC 60318-3 Tone SOUND Tone Fre- IEC 60318-3 IEC 60318-3 ATTENUA- quency Max Level Max Level...
  • Page 89 Operation Manual touchTymp MI 26 and MI 36 Version Calibration Values: High Frequency Headphone DD450 Coupler IEC 60318-1 Tone SOUND Tone Fre- IEC 60318-3 IEC 60318-3 ATTENUA- quency Max Level Max Level RETSPL dB RETSPL dB TION [dB] [Hz] [dB HL] [dB HL] re 20µPa...
  • Page 90 Operation Manual touchTymp MI 26 and MI 36 Version Calibration Values: Bone Conductor Radioear B81 Coupler ISO 389-3, ANSI S3.6 Reference equivalent Frequency threshold Max level [Hz] force level for tone ISO 389-3 Tone [dB] (re 1µN) [dB HL] 67.0 58.0...

  • Page 91: Electromagnetic Compatibility (Emc)

    Operation Manual touchTymp MI 26 and MI 36 Version 6.5 Electromagnetic Compatibility (EMC) ESSENTIAL PERFORMANCE for this device is defined by the manufacturer as: • This device does not have an ESSENTIAL PERFORMANCE • Absence or loss of ESSENTIAL PERFORMANCE cannot lead to any unacceptable immediate risk.
  • Page 92 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 93 Operation Manual touchTymp MI 26 and MI 36 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.
  • Page 94 Operation Manual touchTymp MI 26 and MI 36 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 95: Electrical Safety, Emc And Associated Standards

    Operation Manual touchTymp MI 26 and MI 36 Version 6.6 Electrical Safety, EMC and Associated Standards 1. IEC 60601-1:2005+A1:2012: Medical Electrical Equipment, Part 1 General Requirements for Safety 2. ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1 General Requirements for Safety 3.

  • Page 96: Checklist For Subjective Audiometer Testing

    Operation Manual touchTymp MI 26 and MI 36 Version 6.7 Checklist for subjective Audiometer Testing 8511780 Rev. 4 30/06/2021...

  • Page 97: Appendix A Literature

    Operation Manual touchTymp MI 26 and MI 36 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 98 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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