Maico easyTymp Operation Manual Download Page 64

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Operation Manual easyTymp

8111254 Rev. 7.0

02/16

Electrical Safety, EMC and Associated Standards

(1) UL 60601-1: Medical Electrical Equipment, Part 1 General Requirements for

Safety

(2) IEC 60601-1: Medical Electrical Equipment, Part 1 General Requirements for

Safety

(3) CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1 General

Requirements for Safety Electrical Equipment for Laboratory Use

(4) IEC 60601-1-2: Medical Electrical Equipment, Part 1 - Electromagnetic

Compatibility - Requirements and Tests

(5) Essential Requirements of the current European Union Medical Device Directive

93/42/EEC

(6) RoHS (Restriction of the use of certain Hazardous Substance)

(7) WEEE (Waste Electrical & Electronic Equipment) Legislation

Summary of Contents for easyTymp

Page 1: ...Operation Manual easyTympTM...

Page 2: ......

Page 3: ...8 2 5 Device Control 9 2 6 Electromagnetic compatibility EMC 9 3 Impedance Measurements 10 3 1 Tympanometry 10 3 2 Acoustic Reflex 10 3 3 Contralateral Acoustic Reflex 11 3 4 Acoustic Reflex Decay 11...

Page 4: ...7 Cleaning and Disinfection Recommendations 39 7 1 General Recommondations 39 7 2 Cleaning the probe tip 40 8 Warranty Maintenance and After Sales Service 43 8 1 Warranty 43 8 2 Recycling and Disposal...

Page 5: ...yright 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...

Page 6: ...n easy to learn thus making the device simple and easy to operate This user manual is meant to make it as easy as possible for the operator to become familiar with the operation and functions of the e...

Page 7: ...used by hearing healthcare professionals i e ENT doctors audiologists and other trained personal such as medical technicians neonatal and school nurses The instrument is intended for professional use...

Page 8: ...measurement Ipsilateral acoustic reflexes at several frequencies Contralateral acoustic reflex measurements at several frequencies 1 kHz probe tone option easyTymp Pro Version Contra probe required R...

Page 9: ...MPTING TO USE THIS SYSTEM Use this device only as described in this manual In this manual the following two labels identify potentially dangerous or destructive conditions and procedures The WARNING l...

Page 10: ...horized representative special disposal required Reference number patient applied part type B according to IEC 60601 1 Refer to instruction manual mandatory Read operation instructions Keep away from...

Page 11: ...ion in certain places a recalibration may be necessary No modification of this equipment is allowed Do not drop or otherwise cause undue impact to this device If the instrument is dropped or otherwise...

Page 12: ...er or Ethernet which are connected to the device must meet electrical safety requirements such as IEC 60601 1 series for medical electrical equipment or IEC 60950 for IT equipment This is to avoid ele...

Page 13: ...e use of non calibrated devices can lead to incorrect test results and is not advisable Prevent cable breakage cables must not be bend or buckled Remove batteries both in the hand held unit and the cr...

Page 14: ...lay and printout to aid in diagnosis Compliance is measured with respect to an equivalent volume of air with the scientific quantity milliliter ml for 226 Hz and mmho for 1000 Hz Air is measured in de...

Page 15: ...ion is the measurement of the acoustic reflex response during sustained stimulus presentation Ipsilateral and contralateral reflex decay can be performed 3 5 Eustachian Tube Function Test The Eustachi...

Page 16: ...ease notify the carrier immediately Please remove the MAICO instrument from the shipping box by lifting the cardboard package on the end flaps Holding the package securely fold the side flaps upwards...

Page 17: ...ftware Kit MAICO Impedance Software 1 Operation Manual 1 Quick Guide 1 Carrying case 1 Probe cleaning kit Standard Configuration of Eartip Box 10 Eartip flanged 3 5 mm red 10 Eartip mushroom 7 mm blue...

Page 18: ...artip box power supply unit and additional rechargeable battery Additional Accessories for easyTymp Plus and Pro Version Contra Probe 140 cm CIR55 Contralateral Earphone EARtone 3A Contralateral Earph...

Page 19: ...printer the cradle has up to three indication lights Figure 2 Figure 2 easyTymp LED shows solid blue when it is placed inside the cradle The battery will be charged automatically and will be fully cha...

Page 20: ...nt of the printer Position the loose end into the printer roll and raise it by rotating the printer roll with your finger Figure 5 Figure 6 Step 4 Push the blue lever down Figure 6 Figure 7 Step 5 Clo...

Page 21: ...on the easyTymp unit 4 3 1 6 Installing the easyTymp Battery Figure 9 The battery compartment is opened by gently pressing the indentation and pushing the cover downwards Figure 9 Figure 10 Figure 11...

Page 22: ...s charging Please observe the following precautions Keep the battery fully charged Do not place the battery in fire or apply heat to the battery Do not damage the battery or use a damaged battery Do n...

Page 23: ...king the probe into the end of the extension cable Figure 17 4 3 1 10 easyTymp Plus and Pro Version Connecting the Contralateral Headphone or Insert Phone To measure contralateral reflexes it is neces...

Page 24: ...ase NOTE For installation and functions see the software manual 4 4 Preparing the Test 4 4 1 Patient Instruction Make sure that the patient is comfortably seated in a chair or on an examination table...

Page 25: ...ained during the test The Tester will select the appropriate size of eartip by gently pulling the ear up and back to straighten the ear canal and an estimation of the correct eartip size can be made F...

Page 26: ...utton on the Contra Probe to start or stop pause the current measurement or switch between right and left when the probe is not inserted to the ear Figure 21 4 4 5 easyTymp Plus and Pro Version Placem...

Page 27: ...he 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 pr...

Page 28: ...g the probe status If the 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 p...

Page 29: ...y is almost empty Please change the battery to proceed The following paragraphs describe the precise operation of the different screens you will observe during the use of easyTymp 5 1 Test Figure 26 U...

Page 30: ...hand corner of the screen When the measurement is stopped the top buttons will change to give the option to print or delete arrows will select respectively right or left ear for testing If data on one...

Page 31: ...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 Top right button will present a popup message saying Delete...

Page 32: ...Before performing ipsilateral and contralateral reflex testing tympanometry will be performed Figure 29 NOTE Deflection of reflexes can be positive or negative and is selected within the setup menu 5...

Page 33: ...ts Valsalvation 3 Green represents Swallow Perforated Figure 32 Instruct patient to swallow Measurement of changing pressure indicates status of Eustachian tube Figure 32 5 4 Select Patient Save Figur...

Page 34: ...lient s information is viewed 5 5 Edit New Figure 34 With this screen you can input data for a new client before saving the measurement Figure 34 Operating from this screen saves the patient details a...

Page 35: ...where the data of the selected client is shown will bring you to the View Sessions screen where the available sessions of the selected client can be reviewed and printed will bring you to the top or b...

Page 36: ...acter 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 5 9 View Results...

Page 37: ...no function buttons will show the recordings of the right or left ears respectively if available buttons scroll through the different tests which are included in the selected session 5 10 Setup Figure...

Page 38: ...ough the options Figure 42 buttons adjust Date Date format and Time 5 10 3 Setup easyTymp will scroll through the options buttons to adjust selection Figure 43 The Power Save can be set to Never or 1...

Page 39: ...selection Print Options automatic or manual Reflex Presentation table or graph Printing enabled or disabled 5 10 5 Setup Clinic Info Figure 45 Use Up Down Right and Left arrow keys to move the cursor...

Page 40: ...utor only Figure 47 Use Left Right Up and Down arrow keys to move the cursor over the keyboard Figure 47 The top middle button will select the highlighted character Backspace is an arrow in the top ri...

Page 41: ...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 ba...

Page 42: ...ions for installation 5 Next open the database you are using either NOAH or Maico Database 6 Open the easyTymp module from the database 7 Select Extras Settings from the menu bar 8 Select USB easyTymp...

Page 43: ...Disinfect the instrument and its accessories by wiping the surfaces with wet Sani Cloth Active wipes or a comparable product and allow them to take effect for the duration related to the specific disi...

Page 44: ...system is kept clean at all times Therefore please clean the probe on a periodic basis It is indispensable to remove cerumen from the probe tip s small acoustic and air pressure channels Therefore ple...

Page 45: ...robe channels Use the floss only once Figure 54 Figure 55 5 Place the probe tip back onto the probe Make sure that the plastic pegs are inserted into the appropriate corresponding cavities Figure 55 F...

Page 46: ...ind the thin brush and thin rigid plastic cord Figure 58 Figure 59 Use the plastic cord or brush to push debris out of the probe tip Figure 59 Always enter the probe tip from the rear to avoid accumul...

Page 47: ...ar The service and calibration must be performed by your dealer or to a service center authorized by MAICO When returning the instrument for repairs or calibration it is essential to send the acoustic...

Page 48: ...0 6 A Mains voltages and fuses 100 240 VAC 50 60 Hz Power easyTymp Fuses 3 A 5 V Power Cradle Fuses 3 A 24V Environment Conditions Operation 15 C 35 C 59 F 95 F Humidity 30 90 non condensing Air press...

Page 49: ...omatic Indicators Graphical display Compliance is indicated as ml for 226 Hz and as mmho for 1000 Hz and pressure as daPa Stimulus level is indicated as dB Hearing Level Memory Tympanometry 1 curve pe...

Page 50: ...t signal 226 Hz 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 ran...

Page 51: ...2000Hz and 5 10 dB for 3000 to 4000Hz Pressure measurement 5 or 10 daPa whichever is greater Compliance measurement 5 or 0 1 ml whichever is greater Impedance calibration properties Probe tone Freque...

Page 52: ...e 3 dB lateral Earphone Broad band noise BBN Spectral properties MAICO Standard As Broad band noise specified in IEC 60645 5 but with 500 Hz as lower cut off frequency General about levels The actual...

Page 53: ...nector Probe connector 12 pole CH1 out CH1 GND DGND GND Microphone Microphone input Analog balanced in Microphone input Analog balanced in Power supply 3 5V CH2 out CH2 GND I2C CLK I2C DATA I2C Interr...

Page 54: ...24 5 500 5 5 13 0 9 5 1000 0 0 6 0 6 5 1500 2 0 8 0 5 0 2000 3 0 8 0 12 3000 3 5 8 0 11 4000 5 5 9 0 8 0 6000 2 0 20 5 5 5 8000 0 0 12 0 0 5 WB 5 0 8 0 5 0 LP 7 0 6 0 7 0 HP 7 0 10 0 8 0 Coupler types...

Page 55: ...th 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 Anyone connecting additional equipm...

Page 56: ...of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 23 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1...

Page 57: ...al mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage vari...

Page 58: ...strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equi...

Page 59: ...Intensity Reflex Intensity in dB HL 90 Earside Ipsilateral 05 1kHz Ipsi Reflex Auto Tympanometry Frequency 1 kHz Number of Reflexes tested 4 Frequencies 0 5 1 0 2 0 4 0 kHz Intensity Reflex Min Inten...

Page 60: ...umber of Reflexes tested 2 Test signal 80 Broad band noise Intensity Reflex Intensity in dB HL 80 dB Earside Ipsi and Contralateral 11 Decay Ipsi Number of Reflexes tested 4 Frequencies 0 5 1 0 2 0 4...

Page 61: ...2 2 Use a new probe tip If the system still does not run proceed with step 3 3 Change the complete probe and check if the system is running Extension cable If the device shows leaking please 1 Follow...

Page 62: ...check the USB connection in the PC and the system b Use another USB cable 3 Cradle a Make sure the device is properly placed into the Cradle b Make sure the Cradle is powered while transferring the r...

Page 63: ...h Mazlan Joseph Kei Louise Hickson Asaduzzaman Khan John Gavranich Ron Linning High Frequency 1000 HZ Tympanometry Findings in Newborns Normative Data Using a Component Compensated Admittance Approach...

Page 64: ...Safety 3 CAN CSA C22 2 No 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Electrical Equipment for Laboratory Use 4 IEC 60601 1 2 Medical Electrical Equipment Part 1 Electr...

Page 65: ...11254 Rev 7 0 61 02 16 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...

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