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Maico easyTymp Operation Manual

Other manuals for easyTymp: Operation Manual

Summary of easyTymp

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    Operation manual easytymp.

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    Operation manual easytymp 8111254 rev. 9 1 17/01/2018 contents introduction ............................................................................................................. 3 1.1 general .......................................................................................................

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    Operation manual easytymp 8111254 rev. 9 2 17/01/2018 title: easytymp – operation manual date of issue/last revision: 17/01/2018 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 for ...

  • Page 5: Introduction

    Operation manual easytymp 8111254 rev. 9 3 17/01/2018 introduction this section offers you important information about: the intended use of the device indications and contraindications for use essential performance features and benefits a description of the device 1.1 general thank you for purchasin...

  • Page 6: 1.4 Essential Performance

    Operation manual easytymp 8111254 rev. 9 4 17/01/2018 1.4 essential performance the following is considered essential performance: to generate and present stimulus signals in the audio and pressure ranges as specified in the applicable iec 60645/ansi s3.39 series in normal condition. It is intended ...

  • Page 7: 1.6 Description

    Operation manual easytymp 8111254 rev. 9 5 17/01/2018 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 furthe...

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    Operation manual easytymp 8111254 rev. 9 6 17/01/2018 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 oss...

  • Page 9: For Your Safety

    Operation manual easytymp 8111254 rev. 9 7 17/01/2018 for your safety this section offers you important information about: how to read the operation manual where to spend special attention the customer responsibility the explanation of all regulatory symbols used important cautions and warnings that...

  • Page 10: 2.3

    Operation manual easytymp 8111254 rev. 9 8 17/01/2018 2.2 customer responsibility all safety precautions given in this operation manual must be observed at all times. Failure to observe these precautions could result in damage to the equipment and injury to the operator or subject. The employer shou...

  • Page 11: 2.4 Regulatory Symbols

    Operation manual easytymp 8111254 rev. 9 9 17/01/2018 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 descr...

  • Page 12: 2.5 General Precautions

    Operation manual easytymp 8111254 rev. 9 10 17/01/2018 2.5 general precautions before starting a measurement make sure, that the device works properly. Use and store the device indoors only. For operation, storage and transport conditions see table in section 6. For operation in certain places, a re...

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    Operation manual easytymp 8111254 rev. 9 11 17/01/2018 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 da...

  • Page 14: 2.7 Device Control

    Operation manual easytymp 8111254 rev. 9 12 17/01/2018 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 ...

  • Page 15: 3.1 Warranty

    Operation manual easytymp 8111254 rev. 9 13 17/01/2018 warranty, maintenance and after-sales service this section offers you important information about: warranty conditions maintenance cleaning and disinfection recommendations handling disposables troubleshooting recycling and disposal of the devic...

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    Operation manual easytymp 8111254 rev. 9 14 17/01/2018 3.3 cleaning and disinfection recommendations 3.3.1 general it is recommended that parts (device and accessories like headphones, ear cushions) which come in direct contact with the patient be subjected to standard cleaning and disinfecting proc...

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    Operation manual easytymp 8111254 rev. 9 15 17/01/2018 3.3.2 cleaning the case and cables use caution while cleaning. 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 w...

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    Operation manual easytymp 8111254 rev. 9 16 17/01/2018 figure 5 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 6 4. Proceed in the same way with all 4 probe channels. Use the flos...

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    Operation manual easytymp 8111254 rev. 9 17 17/01/2018 cleaning alternative: figure 9 figure 10 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 11 use the plastic cord or brush to push debris out...

  • Page 20: 3.4 Troubleshooting

    Operation manual easytymp 8111254 rev. 9 18 17/01/2018 3.3.4 disposables figure 15 operating the easytymp will require the use of eartips – either mushroom shaped (1) or umbrella (2) eartips (figure 15). Eartips are intended for single-use only. These should be discarded after use. They cannot be cl...

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    Operation manual easytymp 8111254 rev. 9 19 17/01/2018 issue solution battery slot 1. If the spare battery is not charging, please, check if the battery is properly inserted and the terminals are in contact (springs in cradle). 2. Please make sure the battery contacts are clean in the case. Connecti...

  • Page 22: 3.5 Recycling and Disposal

    Operation manual easytymp 8111254 rev. 9 20 17/01/2018 3.5 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 b...

  • Page 23: Unpacking And Installation

    Operation manual easytymp 8111254 rev. 9 21 17/01/2018 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 probe and the external probe using the mpt-ii ther...

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    Operation manual easytymp 8111254 rev. 9 22 17/01/2018 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 h...

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    Operation manual easytymp 8111254 rev. 9 23 17/01/2018 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 fla...

  • Page 26: 4.2 System Installation

    Operation manual easytymp 8111254 rev. 9 24 17/01/2018 4.2 system installation 4.2.1 hardware installation 4.2.1.1 installing the cradle figure 17 1 = usb in 2 = usb out 3 = usb out 4 = usb out 5 = power 24 v 6 = follow the instructions for use put the enclosed mains cable into the power connection ...

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    Operation manual easytymp 8111254 rev. 9 25 17/01/2018 figure 20 place the battery inside the compartment (figure 20). Figure 21 make sure the battery contacts are aligned before pushing the battery into place (1) and the removal-tab is easy to reach (2) (figure 21). Figure 22 the removal-tab, attac...

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    Operation manual easytymp 8111254 rev. 9 26 17/01/2018 4.2.1.5 battery life 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...

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    Operation manual easytymp 8111254 rev. 9 27 17/01/2018 4.2.1.7 adjust the cradle figure 29 use the allen key to adjust the cradle on the figure 29. Note: an allen key is enclosed in the packaging of the eartip box to enable adjustment of the pair of adjustable feet located on the bottom of the cradl...

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    Operation manual easytymp 8111254 rev. 9 28 17/01/2018 4.2.3 establishing a pc-connection to transfer data to a pc, establishing a pc-connection via usb is required. If the easytymp is used with office equipment that is not a medical device itself (see table 4, pc- connection 1), make sure to establ...

  • Page 31: 4.3 Software

    Operation manual easytymp 8111254 rev. 9 29 17/01/2018 4.3 software you can view and store all measurements with the maico impedance software module. Note: for installation and functions see the software operation manual. For transferring data to the pc see section 5.6. 4.4 using the mpt-iithermal p...

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    Operation manual easytymp 8111254 rev. 9 30 17/01/2018 charging light indicators table 5 mlp-ii charging light indicator green led indicator blue led indicator status sound note off fast flash charging - power on off on charging - power off off slow flash battery nearly discharged - - off on chargin...

  • Page 33: Operating The Device

    Operation manual easytymp 8111254 rev. 9 31 17/01/2018 operating the device this section offers you information about: how to get started with the easytymp the operating panel preparing the patient for testing performing impedance testing settings to be made managing the test results 5.1 getting sta...

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    Operation manual easytymp 8111254 rev. 9 32 17/01/2018 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 ma...

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    Operation manual easytymp 8111254 rev. 9 33 17/01/2018 each ear tip should only be used once. For more detailed information see section 3.3.4. Figure 42 in order to remove the ear tip, grasp the ear tip at the base using the eartip removal tool and pull it smoothly straight off the probe tube (figur...

  • Page 36: 5.3 Start The Test

    Operation manual easytymp 8111254 rev. 9 34 17/01/2018 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. The easytymp will alwa...

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    Operation manual easytymp 8111254 rev. 9 35 17/01/2018 5.5.2 test figure 48 usually the easytymp starts with the test screen. When deleting or saving data after a measurement, you will also return to this screen (figure 48). The graphics of the ongoing test will also be displayed. The box indicates ...

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    Operation manual easytymp 8111254 rev. 9 36 17/01/2018 5.5.3 select test screen figure 49 to change the selected protocol, first highlight the protocol and then press . The following measurements are available in the standard easytymp (figure 49): 01 tymp 226 hz 03 tymp 226 hz + auto reflex 04 tymp ...

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    Operation manual easytymp 8111254 rev. 9 37 17/01/2018 operating from this screen: - : top left button will print the test results of the left and right ear. The printer must be on and a connection to the printer prior to starting the test. Printer icon displays in the top right corner of the screen...

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    Operation manual easytymp 8111254 rev. 9 38 17/01/2018 5.5.6 advanced testing: easytymp pro version acoustic reflex decay figure 53 ipsilateral and contralateral reflex decay testing can be performed (figure 53). Etf intact figure 54 instructions for testing are displayed at the top of the screen. (...

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    Operation manual easytymp 8111254 rev. 9 39 17/01/2018 5.5.7 easytymp plus and 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...

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    Operation manual easytymp 8111254 rev. 9 40 17/01/2018 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 ne...

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    Operation manual easytymp 8111254 rev. 9 41 17/01/2018 5.5.12 edit details figure 60 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 th...

  • Page 44: 5.6 Setup Menu

    Operation manual easytymp 8111254 rev. 9 42 17/01/2018 5.6 setup menu 5.6.1 setup figure 63 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. - the top middle button ...

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    Operation manual easytymp 8111254 rev. 9 43 17/01/2018 5.6.4 setup easytymp figure 66 will scroll through the options. Buttons to adjust selection (figure 66). The power save can be set to never or 1, 2, 3, 4 or 5 min. The power off can be set to never or from 1 to 10 min. Show pass/nr: if on the te...

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    Operation manual easytymp 8111254 rev. 9 44 17/01/2018 5.6.6 setup clinic info figure 69 use up, down, right and left arrow keys to move the cursor over the keyboard (figure 69). To select the highlighted character. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboar...

  • Page 47: 5.7 Managing Test Results

    Operation manual easytymp 8111254 rev. 9 45 17/01/2018 5.6.8 setup patient management figure 72 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. 5.6.9 about figure 73 about displays the firmware ver...

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    Operation manual easytymp 8111254 rev. 9 46 17/01/2018 deleting test results directly after testing deleting a measurement is possible by pressing the button directly after having finished a measurement and the done! Screen is shown. It is possible to delete measurements of one or both ears. See sec...

  • Page 49: Technical Data

    Operation manual easytymp 8111254 rev. 9 47 17/01/2018 technical data this section offers you important information about the easytymp hardware specifications connections the pin assignment impedance calibration values electromagnetic compatibility (emc) electrical safety, emc and associated standar...

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    Operation manual easytymp 8111254 rev. 9 48 17/01/2018 device specifications environment conditions: operation +15 °c to +35 °c / +59 °f to +95 °f humidity: 30 % to 90 %, non-condensing air pressure 98 kpa to 104 kpa 1 maximum altitude: 2000 m / 6561 ft above sea level storage 0 °c to +50 °c / +32 °...

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    Operation manual easytymp 8111254 rev. 9 49 17/01/2018 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. Indicator: measured value is d...

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    Operation manual easytymp 8111254 rev. 9 50 17/01/2018 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 fixed bbn: 80 db hl outputs...

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    Operation manual easytymp 8111254 rev. 9 51 17/01/2018 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. Control tympanometry: automatic time range: 0 ...

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    Operation manual easytymp 8111254 rev. 9 52 17/01/2018 impedance calibration properties probe tone frequencies: 226 hz  1 %, 1000 hz  1 % 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. On-off ratio: snr ratio: a...

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    Operation manual easytymp 8111254 rev. 9 53 17/01/2018 cradle power supply, ue24wcp-240100spa consumption: 0.6 a mains voltages and fuses: 100 - 240 vac, 50 - 60 hz 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” weight 980 g / 2.16 lbs pri...

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    Operation manual easytymp 8111254 rev. 9 54 17/01/2018 6.2 connections and pin assignment easytymp device table 6 pin assignment easytymp outputs connector type pin assignment usb mini usb type „b“” usb port for communication probe connector probe connector, 12-pole ch1 out ch1 gnd dgnd gnd micropho...

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    Operation manual easytymp 8111254 rev. 9 55 17/01/2018 cradle figure 75 table 7 pin assigment cradle no. Connector type pin assignment 1 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. Data - 3. Data + 4. Ground 5 mains dc socket 24 v/3 a - data connector d...

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    Operation manual easytymp 8111254 rev. 9 56 17/01/2018 6.3 reference values for stimulus calibration table 8 coupler types used by calibration iow probe (probe system): calibrated using a iec 60380-5 (2cc) acoustic coupler made in accordance to maico standard values cir55 : calibrated using a iec 60...

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    Operation manual easytymp 8111254 rev. 9 57 17/01/2018 6.4 electromagnetic compatibility the device fulfils the relevant emc requirements. Precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.G. From mobile phones etc. If the device is used adjacent to other equipme...

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    Operation manual easytymp 8111254 rev. 9 58 17/01/2018 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 environmen...

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    Operation manual easytymp 8111254 rev. 9 59 17/01/2018 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. ...

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    Operation manual easytymp 8111254 rev. 9 60 17/01/2018 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 -...

  • Page 63: 6.6  Test Protocols

    Operation manual easytymp 8111254 rev. 9 61 17/01/2018 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: 2...

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    Operation manual easytymp 8111254 rev. 9 62 17/01/2018 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 0...

  • Page 65: Appendix

    Operation manual easytymp 8111254 rev. 9 63 17/01/2018 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....

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    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.