Maico easyTymp Operation Manual
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Maico easyTymp Operation Manual

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  • Page 1 Operation Manual easyTymp...

  • Page 3: Table Of Contents

    1.3 Indications for Use .................... 2 1.4 Contraindications of Use .................. 2 1.5 Essential Performance ..................3 1.6 Features and Benefits of the easyTymp ............. 3 1.7 Description ....................... 4 2 For your Safety ......................6 2.1 How to read this Operation Manual ..............6 2.2 Customer Responsibility ..................
  • Page 4 Copyright © 2016 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

    1.1 General Thank you for purchasing a quality product from the MAICO product family. The easyTymp is designed and manufactured to meet all quality and safety requirements. When designing the easyTymp, MAICO placed particular importance on making it a user- friendly device.

  • Page 6: Essential Performance

    ISO 8253-1. The easyTymp can be used on patients in the age range of infants, children and adults. 1.6 Features and Benefits of the easyTymp...

  • Page 7: Description

    Operation Manual easyTymp 1.7 Description 1.7.1 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 1.7.2 to 1.7.6.
  • Page 8 Contra Probe. 1.7.5 Acoustic Reflex Decay An Acoustic Reflex Decay is available with the easyTymp Pro. 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 9: For Your Safety

    Operation Manual easyTymp 2 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. READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM! Use this device only as described in this manual.

  • Page 10: Customer Responsibility

    MAICO. NOTE: Customer responsibility includes proper maintenance and cleaning of the device (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).

  • 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 SYMBOL DESCRIPTION Serial number...

  • Page 12: General Precautions

    Operation Manual easyTymp 2.5 General Precautions Before measurement make sure, that the device works properly. WARNING Do not immerse the unit in any fluids. For cleaning and disinfection see section 3.3. Use and store the instrument indoors only. For operation, storage and transport conditions see table in section 6.2.
  • Page 13 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 instrument. In order to maintain a high level of safety and to ensure the...

  • Page 14: Device Control

    Operation Manual easyTymp 2.7 Device Control The user of the instrument should perform a subjective instrument check once a week according ISO 8253-1. For annual calibration please see section 3.2. See section 4.2.2 Test cavities for volume check. 2.8 Electromagnetic Compatibility (EMC) Electrostatic discharge (ESD) according to IEC 61000-4-2.

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

    3 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 instrument by MAICO through...

  • 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 53). Figure 53 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 57): Take the cleaning tool apart to find the thin brush and thin rigid plastic cord (Figure 58). Figure 57 Figure 58 Use the plastic cord or brush to push debris out of the probe tip (Figure 59).

  • 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 4. Make sure the easyTymp option is selected in the PC software (for detail contact your distributor). 5. Try to reinstall the PC software. Check the device manager in the PC. If the easyTymp does not appear in the list install the driver again using the installation CD. 15/11/2016...

  • 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 Article (9) of DIRECTIVE 2002/96/EC on waste electrical and electronic equipment (WEEE), MAICO has changed their sales policy.

  • 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 USB cable Power supply Rechargeable battery Roll of paper (with printer cradle) Configuration dependent components for all easyTymp Versions: External Probe (35cm) Wall Mount Kit for cradle with integrated eartip box, power supply unit and additional rechargeable battery Carrying case...

  • Page 25: System Installation

    Operation Manual easyTymp Licenses: License for high frequency probe tone of 1 kHz License for Pro Version: Acoustic Reflexes Contra, Decay and ETF NOTE: License for Pro Version: An upgrade to the device version is required. Consumable Material: Printer paper...
  • Page 26 Operation Manual easyTymp  easyTymp LED shows solid blue when it is placed inside the cradle. The battery will be charged automatically and will be fully charged after approximately three hours. The current battery state of charge may be seen on the easyTymp display.
  • Page 27 Figure 8.1 easyTymp unit. 4.2.1.6 Installing the easyTymp Battery The battery compartment is opened by gently pressing the indentation and pushing the cover downwards (Figure 9). Figure 9 Place the battery inside the compartment (Figure 10).
  • Page 28 6 hours prior to first use of the easyTymp hand-held Tympanometer (Figure 13). 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 13 The spare battery is stored and charged in the back of the cradle (Figure 14).
  • Page 29 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. through...
  • Page 30 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 31: Software

    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 32: Operating The Device

    Operation Manual easyTymp 5 Operating the Device 5.1 Preparing for Testing 5.1.1 Preparing the Patient Make sure that the patient is comfortable on a chair or on an examination table if necessary. Small children may feel more comfortable sitting on a parent's lap.
  • Page 33 Operation Manual easyTymp Put the ear tip tightly on the probe tip making sure it is pushed all the way down (Figure ). Figure 19 Insert the probe with ear tip attached into the patient’s ear. For children and adults, pull gently up and back on the outer ear (i.e.
  • Page 34 Operation Manual easyTymp 5.1.5 easyTymp 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 22). For most patients it is easiest to clip the Contra Probe to the patient.

  • Page 35: Operating Panel

    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. To switch easyTymp off, press both red and blue arrow keys together and hold for one second.

  • Page 36: Testing

    Operation Manual easyTymp probe light stays white in any other situation easyTymp might need to be switched off and on again to regain proper probe status. Flashing color – easyTymp is pausing during a protocol and waits for you to press continue.
  • Page 37 In the upper right corner an icon indicates if the easyTymp is testing the left ear or right ear When entering the Test screen, the second line shows the name of the protocol which is in use.
  • Page 38 Operating from this screen: : Top left button will print the test results of the left and right ear. Note that there should be a connection to the printer by placing the easyTymp in the cradle. : Top middle button will save the measurement of both ears.
  • Page 39 When viewing the first or last test of an ear, pressing up or down respectively will bring you to the test results of the other ear. 5.5.5 Advanced Testing: easyTymp Pro Version Acoustic Reflex Testing (Ipsi and Contra) Before performing Ipsilateral and Contralateral reflex testing Tympanometry will be performed (Figure 31).
  • 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 32). Figure 32 ETF Testing Intact Instructions for testing will be displayed at the top of the screen (Figure 33).
  • 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 client list respectively.
  • Page 42 Operation Manual easyTymp arrows buttons will move the selection of the keyboard one character to the left or right. buttons will move the selection of the keyboard one character up or down. When editing the birth date the up and down button will change the numerical value.
  • Page 43 Operation Manual easyTymp 5.5.11 Edit Details This screen shows the client ID, First Name, Last Name and Birth Date (Figure 39). Operating from this screen: brings you back to the View Details screen. will select the highlighted character and put it where the cursor is placed. Backspace is an arrow in the top right corner.
  • Page 44 Figure 41 are included in the selected session. 5.5.13 Setup To change the Setup of the easyTymp navigate from Test screen to Select test and then to easyTymp (Figure 42). Operating from this screen: brings you back to the Select test screen.
  • Page 45 Operation Manual easyTymp 5.5.15 Setup Date & Time arrow keys will scroll through the options (Figure 44). buttons adjust Date, Date format and Time. Figure 44 5.5.16 Setup easyTymp will scroll through the options. buttons to adjust selection (Figure 45).
  • Page 46 Operation Manual easyTymp 5.5.18 Setup Clinic Info Use Up, Down, Right and Left arrow keys to move the cursor over the keyboard (Figure 47). select highlighted character. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard.

  • Page 47: Managing Test Results

    (Figure 51). Figure 51 5.5.22 easyTymp Pro Version: Contra Probe Button The Contra Probe button will change ears as long as the probe detects it is not in the ear. When the probe is in an ear it will interrupt the testing and bring you to the Done! Screen, and from there also back to the Test screen with a second press of the button.
  • 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 Specifications

    10 of the 93/42/EEC (Appendix IX). 6.2 Technical Data The easyTymp is an active, diagnostic medical product according to the class IIa of the EU medical directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no 0123.
  • Page 50 Operation Manual easyTymp Dimension and weight Dimension W x D x H: 80 x 300 x 70 mm / 3.15” x 11.81” x 2.76” Weight 427 g / 1 lb Warm-up time less than 10 minutes Impedance Measuring System Probe tone:...
  • Page 51 Operation Manual easyTymp Air: Connection of the air system to the probe. Test types: Automated Reflex Automatic reflexes: Single intensities Single reflex auto search Reflex Decay Functions Test method Ipsi- and Contralateral Test signals: Pure Tones: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz each with ±...
  • Page 52 Operation Manual easyTymp communication. Memory: Stores test results for up to 499 patients. The easyTymp hand held unit is delivered with a 8 GB memory card. Calibration properties Calibrated Probe system: Ipsilateral and Contralateral Earphone: is transducers: integrated in the probe system.

  • Page 53: Connections And Pin Assignment

    Operation Manual easyTymp Reflex calibration standards and spectral properties: General Specifications for stimulus signals are made to follow IEC 60645-5 3 dB Ipsi- and Contra- Pure tone: lateral Earphone Broad-band MAICO Standard As “Broad-band noise” specified in IEC 60645- noise (BBN): 5, but with 500 Hz as lower cut-off frequency.

  • Page 54: 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 5 Frequencies and Intensity Ranges for Impedance FREQUENCIES AND MAXIMUM VALUES FOR IMPEDANCE Center Intensities [dB HL] Frequency IP30 CIR55 DD45 C...

  • Page 55: 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 56 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 57 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 58: Electrical Safety, Emc And Associated Standards

    Operation Manual easyTymp 6.6 Electrical Safety, EMC and Associated Standards 1. ANSI/AAMI ES/IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety 2. CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety Electrical Equipment for Laboratory Use 3.

  • Page 59: Test Protocols

    Operation Manual easyTymp 6.7 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 60 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 Earside: Ipsi- and Contralateral 09 1kHz + Ipsi-Contra Auto Tympanometry, Frequency: 1 kHz Number of Reflexes tested = 8, Frequencies: 0.5, 1.0,...

  • Page 61: Appendix

    Operation Manual easyTymp 7 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 62 Operation Manual easyTymp Specifications are subject to change without notice. MAICO Diagnostics 10393 West 70th Street Eden Prairie, MN 55344 Tel.: 888.941.4201 Fax: 952.903.4100 E-mail: info@maico-diagnostics.com Internet: www.maico-diagnostics.com 15/11/2016 8108757 Rev. 3...

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