Maico easytymp Operation Manual
  1. Manuals
  2. Brands
  3. Maico Manuals
  4. Medical Equipment
  5. easyTymp
  6. Operation manual

Maico easytymp Operation Manual

Hide thumbs Also See for easytymp:
Table of Contents

Advertisement

Quick Links

Operation Manual
easyTymp

Advertisement

Table of Contents
loading

Related Manuals for Maico easytymp

Summary of Contents for Maico easytymp

  • Page 1 Operation Manual easyTymp...

  • Page 3: Table Of Contents

    1.2 Intended Use Statement ................... 3 1.3 Contraindications of Use .................. 3 1.4 Essential Performance ..................4 1.5 Features and Benefits of the easyTymp ............. 4 1.6 Description ....................... 5 For Your Safety ......................7 2.1 How to Read This Operation Manual ..............7 2.2 Customer Responsibility ..................
  • Page 4 Copyright © 2017 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. The information in this publication is proprietary to MAICO.

  • Page 5: Introduction

    It features tympanometry and acoustics reflex. Target population The easyTymp intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in the age range of infant to adults.

  • Page 6: Essential Performance

    ISO 8253-1. The easyTymp can be used on patients in the age range of infants, children and adults. 1.5 Features and Benefits of the easyTymp...

  • Page 7: Description

    Operation Manual easyTymp 1.6 Description 1.6.1 General Dependent on the configuration the easyTymp offers the following Impedance measurements:  Tympanometry  Acoustic Reflex  Contralateral Acoustic Reflex  Acoustic Reflex Decay  Eustachian Tube Function Test Further information on the different tests are given in sections 1.6.2 to 1.6.6.
  • Page 8 The Eustachian tube connects the middle ear with the nasopharynx. Its function is to equalize pressure between the middle ear and the atmosphere. The Eustachian tube test is available with the easyTymp Pro Version. It can be used to determine if the Eustachian tube is functioning properly in patients with an intact tympanic membrane or in patients who have a perforated TM or pressure equalization tubes.

  • 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 easyTymp 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 easyTymp 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 REGULATORY SYMBOLS SYMBOL DESCRIPTION...

  • Page 12: General Precautions

    No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. No part of the equipment can be serviced or maintained while in use with the patient.
  • Page 13 Operation Manual easyTymp Do not position the cradle or the printer in a way that it is difficult to operate the disconnection device. The supply mains and the power socket shall be accessible at all times. Do not use the device if the mains cable and/or the outlet is damaged.

  • Page 14: Device Control

    To avoid the risk of electric shock, this equipment must only be connected to the medical power supply originally delivered by MAICO. Using another power supply can also lead to electrical damage on the device. In order to maintain a high level of safety and to ensure the...

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

    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 the distributor from whom it was purchased and covers defects in material and workmanship for a period of at least one year from date of delivery of the device to the original purchaser.

  • Page 16: Cleaning And Disinfection Recommendations

     Before cleaning always switch off and disconnect the device from power supply.  For cleaning use a lightly dampened cloth with soap water solution.  Disinfect the plastic housing of the easyTymp and its accessories by wiping the ®...
  • Page 17 3.3.2 Cleaning the Case and Cables Use caution while cleaning. CAUTION Use a damp cloth to clean the plastic parts of the easyTymp. If disinfection is required, use a disinfectant wipe rather than a spray product. Make sure that excess liquid from the wipe...
  • Page 18 Operation Manual easyTymp 3. Insert the blue end of the floss from back to front through one of the probe channels. Pull the floss along its entire length through the channel (Figure 5). Figure 5 4. Proceed in the same way with all 4 probe channels.
  • Page 19 Operation Manual easyTymp Cleaning alternative: Use the cleaning set from the eartip box (Figure 9): Take the cleaning tool apart to find the thin brush and thin rigid plastic cord (Figure 10). Figure 9 Figure 10 Use the plastic cord or brush to push debris out of the probe tip (Figure 11).

  • Page 20: Troubleshooting

    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. 3.3.5 Components/Replacement Parts Some reusable components are subject to wear with use over time.
  • Page 21 Make sure the device is properly placed into the Cradle. b. Make sure the Cradle is powered while transferring the result to PC. 4. Make sure the easyTymp option is selected in the PC software (for detail contact your distributor).

  • Page 22: 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...

  • Page 23: Unpacking And Installation

    4.1 Unpacking the system Check Box and Contents for Damage  It is recommended that you unpack your easyTymp carefully making sure that all components are removed from the packing materials.  Verify that all components are included as shown on the packing slip included with your shipment.
  • Page 24 Operation Manual easyTymp The easyTymp 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 easyTymp Handheld Unit MAICO Impedance Module Bundle Probe* Short extention cable (350 mm incl.
  • Page 25 Operation Manual easyTymp 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 26: System Installation

    Figure 18 in the cradle is fully charged. The LED will flash while the battery is charging. NOTE: Upon initial setup, always plug the cradle into the outlet while the easyTymp is out of the cradle. 4.2.1.3 Installing the easyTymp Battery...
  • Page 27 6 hours prior to first use of the easyTymp hand-held Tympanometer (Figure 24). To charge the battery please place the easyTymp into the cradle and connect the cradle to the mains power with the use of the easyTymp power supply provided. Figure 24 The spare battery is stored and charged in the back of the cradle (Figure 25).
  • Page 28 The following table gives an estimate of the charging time (CT) in hours for the battery. Be aware that negative numbers mean that the battery is discharging. Charge times are the same for the spare battery in the cradle and the battery in the cradled easyTymp. See also Table 3.
  • Page 29 4.2.2 Test cavities The easyTymp comes with a separate test cavity which can be used to quickly check the probe calibration validity. The test cavity includes 0.2 ml, 0.5 ml, 2.0 ml and 5.0 ml cylinders.
  • Page 30 Medical device – Laptop (battery-driven) 4.2.4 Storage When the easyTymp is not in use, store it in the optional carry case or in a location where it will be safe from damage to the touchscreen or other sensitive components such as the Acoustic transducers and cables.

  • Page 31: Software

    Green Power indicator will be lit if printer is powered by battery (Figure 35). Figure 35 NOTE: Selecting Print on the easyTymp when the printer is off will result in an error message. Printer must be on and in close proximity of the easyTymp for printing to proceed. 17/01/2018...
  • Page 32 4.4.3 Connecting the MPT-II Thermal Printer to easyTymp The connection of the easyTymp and the printer is made via wireless pairing. See section 5.6.5. NOTE: It is possible to pair four devices with one printer. Do not have several printers powered on and within range while searching.

  • Page 33: Operating The Device

    Arrow Keys: Turn on easyTymp by pressing the right or left arrow key. Turn off easyTymp by pressing both keys at the same time. Selection of the right or left ear to be tested. Up and down buttons: Scroll through the different easyTymp settings menu, test protocols or scroll up and down on the display.
  • Page 34 Operation Manual easyTymp 5.2.2 Visual Inspection of the Ear Canal Check the external ear canal for wax with an otoscope. Excessive wax should be removed by a qualified professional to prevent the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut for a seal to be obtained.
  • Page 35 (see section 3.3.3) or replaced Figure 42 5.2.5 easyTymp Plus and Pro Version: Placing and Using the Contra Probe A clip is located on the back of the Contra Probe which can be attached to the patient’s clothing (Figure 43). For most patients it is easiest to clip the Contra Probe to the patient.

  • Page 36: Start The Test

    5.3 Start the Test To get started, removing the easyTymp from the cradle will turn the device on automatically. If you don’t store the easyTymp in the cradle, press either the red or blue arrow key to switch the device on.
  • Page 37 . When the easyTymp is placed in the cradle, it will charge the battery and a flashing battery icon will be shown. In the upper right corner an icon indicates if the easyTymp is testing the left ear or right ear...
  • Page 38 5.5.4 Done! easyTymp will automatically go to the Done! screen when it has finished testing (Figure 50). From here, measurements of both ears can be reviewed, printed and/or saved.
  • Page 39 5.5.5 Advanced Testing: easyTymp Plus and Pro Version Acoustic Reflex Testing Before performing Ipsilateral (Figure 51) and Contralateral reflex (Figure 52) testing Tympanometry will be performed.
  • Page 40 Operation Manual easyTymp 5.5.6 Advanced Testing: easyTymp Pro Version Acoustic Reflex Decay Ipsilateral and Contralateral Reflex Decay testing can be performed (Figure 53). Figure 53 ETF Intact Instructions for testing are displayed at the top of the screen. (Figure 54).
  • Page 41 After saving, all data is deleted and easyTymp returns in the Test screen, ready for testing. buttons will bring you to the top or bottom of the patient list respectively.
  • Page 42 Operation Manual easyTymp Operating from this screen: saves the patient details and brings you back to Select Patient & Save. will select the highlighted field. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard will select the next details for editing.
  • Page 43 Operation Manual easyTymp 5.5.12 Edit Details This screen shows the patient ID, First Name, Last Name, and Birth Date (Figure 60). Operating from this screen: brings you back to the View Patients screen. selects the highlighted character and put it where the cursor is placed.

  • Page 44: Setup Menu

    Operation Manual easyTymp 5.6 Setup Menu 5.6.1 Setup To change the Setup of the easyTymp navigate from Test screen to Select Test and then to easyTymp (Figure 63). Operating from this screen: brings you back to the Select test screen.
  • Page 45 Figure 67 Select the printer using the buttons and press to configure the device to the wireless printer provided by MAICO (Figure 68). Select to exit the Setup Printer screen. NOTE: The printer must be turned on by pressing the power button before starting the pairing process.
  • Page 46 Operation Manual easyTymp 5.6.6 Setup Clinic Info Use Up, Down, Right and Left arrow keys to move the cursor over the keyboard (Figure 69). select highlighted character. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard.

  • Page 47: Managing Test Results

    Operation Manual easyTymp 5.6.8 Setup Patient Management Turns the internal patient data management On or Off (Figure 72). NOTE: When changing from On to Off, all measured and/or stored data will be deleted. Figure 72 5.6.9 About About displays the firmware version and calibration dates (Figure 73).
  • Page 48 To transfer data between easyTymp and the Impedance Software Module, complete the measurement and connect the easyTymp to the PC. Connection is made via the USB cable inserted directly into the USB port on the device or placement of easyTymp in a connected cradle. The transfer process will start automatically.

  • Page 49: 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 50 240 x 320 PC connection: USB: Input/output for computer communication. Memory: Stores test results for up to 499 patients. The easyTymp hand held unit is delivered with a 8 GB memory card Continuous Mode of operation Dimensions Probe 34 mm Dimensions External...
  • Page 51 Operation Manual easyTymp IMPEDANCE MEASURING SYSTEM Probe tone: Frequency: 226 Hz, 1000 Hz Level: 85 dB SPL at 226 Hz, 69 dB SPL at 1000 Hz with AGC, assuring constant level at different ear canal volumes. Air pressure: Control: Automatic.
  • Page 52 Operation Manual easyTymp ACOUSTIC REFLEX FUNCTIONS Stimulus: Type: Ipsilateral and Contralateral:  Pure tone (500, 1000, 2000, 4000 Hz)  Broad-band noise (BBN) Level: Automatic pure tone: 70-100 dB HL in 5 dB steps Fixed pure tone: 90 dB HL...
  • Page 53 Operation Manual easyTymp ETF – PERFORATED Test signals: Pure tone: 226 Hz with ± 1 % Test level: 85 dB SPL ±1.5 dB measured in an IEC 60318-5 Acoustic coupler. The level is constant for all volumes in the measurement range.
  • Page 54 Operation Manual easyTymp IMPEDANCE CALIBRATION PROPERTIES 226 Hz  1 %, 1000 Hz  1 % Probe tone Frequencies: 85 dB SPL 1.5 dB measured in an IEC 60318-5 Level: Acoustic coupler. The level is constant for all volumes in the measurement range.
  • Page 55 Operation Manual easyTymp CRADLE Power supply, Consumption: 0.6 A UE24WCP-240100SPA Mains voltages 100 - 240 VAC, 50 - 60 Hz and fuses: Power Fuses: 24V/3 A Dimensions and Weight Dimensions Max. 280 mm x 250 mm x 120 mm 11.02” x 9.84” x 4.71”...

  • Page 56: Connections And Pin Assignment

    Operation Manual easyTymp 6.2 Connections and Pin Assignment easyTymp device Table 6 Pin Assignment easyTymp OUTPUTS CONNECTOR PIN ASSIGNMENT TYPE USB Type „B“” USB mini USB port for communication Probe Probe connector, CH1 out connector 12-pole CH1 GND DGND GND Microphone Microphone –...
  • Page 57 Operation Manual easyTymp Cradle Figure 75 Table 7 Pin Assigment Cradle CONNECTOR PIN ASSIGNMENT TYPE USB in USB 2.0 1. +5 VDC 2. Data - 3. Data + 4. Ground 2 to 4 USB out USB 2.0 1. +5 VDC 2.

  • Page 58: Reference Values For Stimulus Calibration

    20.5* 3.0* 8000 12.0* -5.0* -5.0 -8.0* -5.0* *All values marked with at star are MAICO Standard Values. Table 10 Frequencies and Intensity Ranges for Impedance FREQUENCIES AND MAXIMUM VALUES FOR IMPEDANCE Intensities [dB HL] Center Frequency CIR55 DD45 C...

  • Page 59: Electromagnetic Compatibility

    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 delivered from MAICO, 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 60 Operation Manual easyTymp Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The easyTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the device is should assure that it is used in such an environment.
  • Page 61 Operation Manual easyTymp Guidance and manufacturer’s declaration — electromagnetic immunity The easyTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

  • Page 62: Electrical Safety, Emc And Associated Standards

    Operation Manual easyTymp 6.5 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 63: Test Protocols

    Operation Manual easyTymp 6.6 Test Protocols NOTE: Test protocols are configuration dependent. 01 226Hz Tympanometry, Frequency: 226 Hz Earside: Ipsilateral 02 1kHz Tympanometry, Frequency: 1 kHz Earside: Ipsilateral 03 226Hz + Ipsi Reflex Auto Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz...
  • Page 64 Operation Manual easyTymp 08 226Hz + Ipsi-Contra 90 dB Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 8, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex (Intensity in dB HL) = 90 Probe frequency during reflexes: 226 Hz Earside: Ipsi- and Contralateral...

  • Page 65: Appendix

    Operation Manual easyTymp Appendix 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. j. otorhinolaryngol. vol.78 no.1 São Paulo Jan./Feb. 2012 Carvallo RMM, „Medida de imitância acústica em crianças de zero a oito meses de...
  • Page 66 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...

Table of Contents