Operating Instructions easyTymp
Contents
1. rrrrrrrvrrrvrrrvrrrvrrrvrrrvrrrvrrrvrrrvarnvsrnrsrnrsrnnsenn 15 3 4 Cleaning the Probe tip rrrrrvrrrvrrrvarrvarnrarrrrnr vnr seen seen eeeeeseeeseeeetaesenees 16 4 Operating easy TyMp EEE 17 A Onaran P NE aa E E N 17 4 2 Getting started EE rr rr rrt r rreren errr rrer rererere rreren 17 4 3 Probe status indication rrarrrvrrrvrrrvrrrvrrrvrrrvarrvarnvarnrarrrarnrsrnrsenruennvene 18 4 4 Operating eaSyTyYmp arrarranranranrannnnnnnnnnrnnnnernenvennerrennenranrsarsarnnsennen 18 EEE EE etn eceereomeneoenendesnewe 19 4 4 2 Select Test Screen rrrrurnrurnrarnrurnrarnrnrnrvrrrvrnrvrrrvrsrvrrrvsrnvrsrvesnvsennnn 21 4 4 3 DONE o EEEE EEEE EEEE aaa 21 Geba_easyTymp_Fe_12a docx 1 853 263 4 01 12 Operating Manual easy lymp 4 4 4 Select Patient amp SAVE ccccccecececececececececececucecececeteteteteeereeneenes 44 5 Edit NeW ee ee en 4 4 6 View Patients cccccccececcccecececcaceceeeeeecseaeutereatteecetateeertatetereates 4 4 7 View DetallS ccccccccccccccecececececececececececcesecueueeteeeteteteteeetereentenes 44S Fot DE av 4 4 9 View Results cece ccccecececececececececececececacecesatteteceeeteteteteteteteentenes 4 4 10 View Results cc cc ccececccececececececececececececetectececetetetetetetetereeneenes AIRS hss 0 EE EE 4 5 1 Setup LANGUAGE cece cece cee ee cence cence cence eee eea seen sense een eeeeneen ones 4 5 2 Setup Date amp TMC ccc ccc ccc ce cee ce cece eee2. 3 1 1 Supported Software MAICO Impedance Software BDT GDT NOAH3 3 2 Unpacking and inspecting Check the packaging and content for damage Thoroughly inspect the exterior of the shipping for any sign of damage or tempering Should any damage be noted please notify the carrier immediately If the content box has been damaged during transportation the instrument should be checked for any electrical or mechanical defects Should any detects be identified please contact the responsible dealer Keep all original packaging to facilitate any insurance claims against the damages Keep the original packaging for future shipment The easyTymp Is packaged in a specially designed box Please keep the box as it will be useful for sending the instrument for the annual instrument check up as required by law Please contact your nearest responsible dealer should the annual instrument check up be needed Please check that all accessories listed below are received in good condition It any accessories are missing or damaged immediately notify your MAICO Special Instrument Distributor Geba_easyTymp_Fe_12a docx 8 853 263 4 01 12 M Operating Manual MAICO easy lymp Standard Accessories easyTymp handheld unit Probe Probe Tip replacement 1 Rechargeable battery Power supply unit for easyTymp handheld unit only when operating without cradle Eartip box configuration see below Calibration cavity Carrying case Operating
3. B Sa Print Options automatic or manual eflex Presentation table PR Reflex Presentation table or graph Printing enabled or disabled Printing enabled 4 gt Back Save Geba_easyTymp_Fe_12a docx 27 853 263 4 01 12 MAICO 4 5 5 Setup Clinic Info 1 au Z pe 5 gt T O N a Woy pow Cc a m Hom co TN Ke 4 qn eSTez ae OG Ee E M x eK 4 5 6 Setup License Setup License ci 1000Hz License Back Select Setup License Impedance Serial No 01842167 License Key 27777666 01723456 7894 ABCDEFGHIJKLMA NOPORSTUYWXYZ2 abcdefghijklm oO rstuvux yz Eack Edit Geba easyTymp Fe 12a docx lt N ZN Save Select Operating Manual easy lymp Use Up Down Right and Left arrow keys to move the cursor over the keyboard Top middle button will select the highlighted character and put it where the cursor is placed Backspace is found as an arrow in the top right corner Space is found as a bar underneath the keyboard Top right button will select the next details for editing Top left button to save and return to the Setup screen Option Extra software license for high frequency probe tone of 1 kHz By pressing the Top right button you can select the module you want to view or change the license key Use Left Right Up and Down arrow keys to move the cursor over the keyboard Top middle button wil
4. MAICO Diagnostic GmbH MAICO Operating Instructions easy lymp MAICO Diagnostic GmbH Salzufer 13 14 D 10587 BERLIN Tel 49 30 70714650 Fax 49 30 70714699 Operating Manual easy lymp Table of Contents Page 1 INtrOduUCtION EEE 3 1 1 DY lt 1 0 0 3 NNN 4 2 Impedance measurements arnraunrurnrvrnrvrrrvrrrvrrrvrrrvrrrvservsenvsrnvsrnnsrnnsrnnsenn 6 ZANE 6 2 2 Acoustic Reflex rnrnrersrvarrrvrerrarrrvrrrrrrrvrerrerrrvsrnrsrrrvsrnrverrvsenrvrsnrsenrvsnn 6 3 Getting Sire OG EEE EEE 8 3 1 PC system FEQUIFEMENNS 0 ccc cc cec cece nec c cece een eec eee eed eeee een eeneeen een eeneeeneen 3 3 1 1 Supported Software rarnrvrrnrnrnrvrrnrnrrrvnrnrvrrrrerrrvrenrsrrrvsrnrsenrvsennen 8 3 2 UNPACKING and Inspecting rrrrrrrerrrvrrrvrrrvrrrvrrrvrrrvrrrvrrrvrrnvsrnvsrnrrnrsenn 8 3 2 System installation rrrvrrrvrrrvrvrvrrrvarrrarrrarnrarnrarnrsrnrvrrrvrrrvenrvrrnvsennnn 10 3 2 1 Hardware installation rrrerrrnrrrvrrrvrrrvrrrvrrrvrrrvrrrvarnvsrnvsennsrnrsenn 10 3 2 2 Optional Software rr rrrrrnrvrrrvrenrvrrnvrrrrvrrnrsrrrvrerrverrvsrnrvrrrvsrnrvsenn 14 3 3 Preparing the test rrrrnrrrrvrrrvrrrvrrrvarrvarnvarnrernrarnreenrernrvenrvenrvrsnvsennn 15 3 3 1 Patient INStructlon rorrrrrrarrvrnvrrrarrvrrvenrarrarnvanranrnenvennannnennennsnn 15 3 3 2 Visual inspection of the ear canal rarrrvrrnnnrnrvrvnrnrrrvrrnrvrrrvsrrrvrenn 15 3 3 3 Handling the eartips
5. Humidity 10 95 Dimension and Dimension W x D x H 80 x 300 x 70 mm weight Weight 4279 Impedance Measuring System Probe tone Frequency 226 Hz 1000 Hz Level 69 dB HL with AGC assuring constant level at different ear canal volumes Air pressure Control Automatic Indicator Measured value is displayed on the graphical display Range 400 to 200 daPa Pressure limitation 750 daPa and 550 daPa Compliance Range 0 1 to 8 0 ml at 226 Hz probe tone Ear volume 0 1 to 8 0 ml and 0 1 to 15 mmho at 1000 Hz probe tone Test types Tympanometry Automatic Indicators Graphical display Compliance is indicated as ml tor 226 Hz and as mmho tor 1000 Hz and pressure as daPa Stimulus level is indicated as dB Hearing Level Geba_easyTymp_Fe_12a docx 33 853 263 4 01 12 M MAICO Memory Reflex Functions Signal sources Outputs Test types General PC connection Memory Operating Manual easy lymp Tympanometry Tone Ipsi Reflex Noise Ipsi Reflex Ipsi Earphone Air Automated Reflex USB Geba_easyTymp_Fe_12a docx 34 1 curve per ear per tympanometry test And theoretically an infinite number of tests per protocol 500 1000 2000 4000 Hz max 100 dB p Wide Band Probe earphone incorporated in the probe system for Reflex measurements Connection of the air system to the probe Automatic reflexes Single intensities Single reflex auto search Input out
6. M Operating Manual MAICO easy lymp 3 4 Cleaning the probe tip In order to secure correct impedance measurements it is important to make sure that the probe system is kept clean at all times Therefore please follow the below illustrated instructions on how to remove e g cerumen from the small acoustic and air pressure channels of probe tip Never clean the probe tip while the tip is still fitted on the probe Unscrew the probe cap of the probe by turning counter clock direction Take the probe tip out of the probe Take the cleaning tool apart to find the thin brush and thin rigid plastic cord Use the plastic cord or brush to push contamination out of the probe tip Always enter the probe tip from the rear to avoid accumulation of contamination inside the vents Place the probe tip back onto the probe Make sure that the different holes fit in the corresponding cavities Screw the probe cap back on the probe Finger force will tighten the screw sufficiently Never use tools to fix the probe cap If any blockage or damage occurs to the sealing gasket the probe system can only be serviced by MAICO Geba_easyTymp_Fe_12a docx 16 853 263 4 01 12 M Operating Manual MAICO easy lymp 4 Operating easyTymp 4 1 Operating Panel a MAICO Function Keys ET Vi Top buttons Function of the keys is related 5 ear to the functions indicated in the display above the individual function key e g Select
7. easyTymp to ensure its user friendliness meaning that its operation is simple easy to learn and to understand As all the functions are software controlled upgrading the software and or adding additional functions at a later date will be simple and cost effective By purchasing the easyTymp you have made a decision towards long term investment This operating manual aims to make learning and understanding the different easyTymp functions as quick and as easy as possible Should you encounter any problems or have ideas for any further improvements we are only a phone call away Please do not hesitate to contact Us Your MAICO Team Note Although upmost attention has been given to ensure the accuracy of the operating manual some minor errors may still exist We do apologize for any inconvenience this may cause 1 1 Description The easyTymp is an automatic impedance audiometer well suited to perform tympanometry and screen acoustic reflexes on people of all ages The easyTymp is intended to be used by hearing healthcare professionals i e ENT doctors audiologists trained technicians as well as neonatal nurses and school nurses in a quiet environment The handheld unit also enables the transfer of data to a PC via USB connection The easyTymp cradle serves as a docking station and recharger It is available as a version with ear tip box or integrated printer Geba_easyTymp_Fe_12a docx 3 853 263 4 01 12 Operating Manual ea
8. eee eee een een een een een een eens 4 5 3 Setup CASYTYIMP ccccccceceececeeceeeeeeseeeeceeeeseceeeeeeeceseeseenesaeaetaeees 4 5 4 Setup Printer 2 cece cece cece nce ee cece need eee een eed eeee een eedeeeneeneedeeeneens 4 5 5 Setup Clinic INTO oo cece cecccecceeeeceeeeeeeeeeeeeeeneeeeestuneetaeseanestaneenness 4 5 6 Setup LICENSE 22 cece cece ence cee ee ceca eee eeceeceecece eee eee een een een een een eens 4 5 7 Setup Patient Management ccccc cece eec cee eeceeeeeeneeeeeneeneeeneens 4 58 ADOUt eee ee 5 Warranty Maintenance and Service rrrrrnrvrnrvrrrvrrrvrrrvrrrvrrrvsrnvsrnrnrnnsenn 6 DISINFECTION E 7 Safety Regulations c cc ccccccc cece ececeeeeeeeeeeeseueeeeeestueeeeueseuneeeaeseenestansenness 7 1 Electrical SAT EEE 7 2 Measurement SATCLY ccccecccceccc cece eceee esse eeeeeseeeeeeeeseeneceueseenestaneeaness 7 3 Instrument Handling 0 cece cece ccc ec cee eee cece cece eeeeeeeeeeeeeeeeeseeeeeaeetaeseaees 7 4 0 EEE 7 5 Patient Safety EE 8 Technical Data EEEE Geba_easyTymp_Fe_12a docx 2 853 263 4 01 12 M Operating Manual MAICO easy lymp 1 Introduction Thank you for selecting one of our quality products from the MAICO family range The easyTymp is designed and manufactured to meet all quality and safety requirements and has been certified with the CE symbol according to Medical Directive Particular attention has been taken during the designing phase of the
9. lymp Any person who connects external equipment to signal input signal output or other connectors has created a system and is therefore responsible for the system complying with the requirements of IEC 60601 1 1 If in doubt contact your service technician or local representative for help The cradle connection provides power for the thermal printer In order to maintain a high level of safety it is necessary to have the instrument and its power supply checked according to the medical electrical safety standard IEC 60601 1 on a yearly basis by a qualified service technician Geba_easyTymp_Fe_12a docx 32 853 263 4 01 12 M Operating Manual MAICO easy lymp 8 Technical Data The easyTymp is an active diagnostic medical product according to the class lla of the EU medical directive 93 42 EEC i Approval of the quality system is made by TUV identification no 0123 Medical CE mark TUV identification no 0123 C Standards Safety IEC 60601 1 Class Il Type B EMC IEC 60601 1 2 pe Impedance IEC 60645 5 ANSI 53 39 Type 1 Power UE24WCP Consumption 0 6 A 240100SPA Mains voltages and 100 240 VAC 50 60 Hz fuses Power easyTymp Fuses 3 A 5V Power Cradle Fuses 3 A 24V Operation Temperature 15 35 C environment Rel Humidity 30 90 Storing handling Temperatures below 0 C and above 50 C may cause permanent damage on the instrument and Its accessories Transport Temperature 20 50 C Rel
10. Test Patient Stop DP Arrow Keys Turn on easyTymp by pressing the right or left arrow key Turn off easyTymp by pressing both keys at the same time AVUp and Down buttons Scroll through the different easyTymp settings menu test protocols or up and down the display 2 1 Select Test P tient Stop aga VAF N 4 2 Getting started To get started take the easyTymp out of the cradle In default setting it will turn on automatically If you don t store the easyTymp in the cradle press either red or blue arrow key to switch the device on To switch easyTymp off press both red and blue arrow keys together and hold tor one second easyTymp will always start within the test screen ready to start a measurement It will use the same protocol as previously used Geba_easyTymp_Fe_12a docx 17 853 263 4 01 12 M Operating Manual MAICO easy lymp 4 3 Probe status indication If you use the optional external probe the indication the light at the back of the probe indicates the probe status with following colors TTT Red Right ear is selected Probe is out of ear Blue Lett ear is selected Probe is out of ear Green Probe is in the ear and Is sealing test is running Yellow Probe is in the ear and blocked or leaking White The probe has just been attached Probe status is unknown The probe status stays white in hand held use if the easyTymp is not monitoring the probe sta
11. al easy lymp To change the Setup of the easyTymp navigate from Test screen to Select test and then to easyTymp Operating from this screen Top left brings you back to the Select test screen Top middle button has no function Top right button selects the highlighted setting to be viewed Right and Left buttons have no function Up and Down buttons make you move up and down to the next item Use right and lett arrow keys to adjust language Available languages are English German Spanish French and Italian 26 853 263 4 01 12 Operating Manual MAICO easylymp 4 5 2 Setup Date amp Time Use right and left arrow keys to go to the next Date 14 02 2011 or previous Item Date format DD HM YYYY Use Up and Down to adjust Date Date format Time 13 19 07 and time Back Save 4 5 3 Setup easyTymp Use Up and Down to go to the next and a previous item Use right and left arrow keys to Neyer dH go to adjust The Power Save can be set to never or 1 2 3 4 or 5 minutes The Power Off can be set to never or from 1 Power Off 8 min 4 Show Pass Fail On 4p to 10 minutes PA ROTE n PR Show Pass Fail If On the result with a Pass Fail symbol Show Calibration Warning On you will be reminded in calibrating the device Back Save 4 5 4 Setup Printer Use Up and Down to go to the next and Print Option previous item Use right and lett arrow keys to automatic 4 QO to adjust
12. as finished testing From here measurements of both ears can be a reviewed printed and or saved Of course you can also directly start a new measurement in the Test 0 screen from here hd 600 300 300 daPa Volume 1 65 mi Pressure 1 daPa Compliance 0 67 mi Gradient 69 daPa Print Save Delete Operating from this screen Print Top left button will result in printing 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 Save Top middle button will save the measurement of both ears Geba easyTymp Fe 12a docx 2i 853 263 4 01 12 Operating Manual easy lymp MAICO Delete Top right button will pop up a message saying Delete current or both ears the Top left button will cancel the process The Top middle button will delete the data of the currently selected ear and bring you back to the Test screen The Top right button will delete data on both ears and bring you back to the Test screen Right and Left buttons will select respectively right or left ear for testing and brings you back to the Test screen The existing data of chosen ear will only be deleted after the probe is detected to be in the ear with a proper seal Up and Down buttons make you scroll through the different test results When viewing the first or last test of an ear pressing respectively Up or Down will bring you to the test result
13. ctly placed Replace the lid on the easyTymp and push it upwards to close the battery compartment If not in operation for longer periods it is recommended to remove the battery from the instrument Geba easyTymp Fe 12a docx 12 853 263 4 01 12 Operating Manual easy lymp 3 2 1 6 Charging the battery The spare battery is stored in the charger in the back of the cradle Battery LED shows solid blue when the spare battery in the cradle is fully charged The LED will flash as long as the battery is 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 not expose the battery to water Do not short circuit the battery or reverse the polarity Use only the charger provided with the easyTymp Please see the following section for estimated charging times 3 2 1 7 Battery lifetime The following table gives an estimate of the charging time ct in hours of the battery Be aware that negative numbers mean that the battery is discharging Charge times for the spare battery in the cradle and the battery in the easyTymp while in the cradle are the same ct through cradle ct through USB ct through cradle ct through USB up to 80 PC up to 80 up to 100 PC up to 100 On pump off 28 32 41 47 3 2 1 8 Changing probes 7 To release the probe press the button at
14. e 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 ossicular chain which changes the compliance of the middle ear system As in Tympanometry a probe tone is used to measure this change in compliance When the stimulus presentation and measurement are made in the same ear by means of the probe this acoustical reflex is referred to as an ipsilateral acoustic reflex For best results this reflex measurement is automatically conducted at the air pressure value where the compliance peak occurred during the tympanometric test Stimulus tones of varying intensities at 500 1000 2000 or 4000 Hz are presented as short bursts If a change in compliance greater than 0 03 ml is detected a reflex is considered present Because this is an Geba_easyTymp_Fe_12a docx 6 853 263 4 01 12 M Operating Manual MAICO easy lymp extremely small compliance change any movement of the probe during the test may produce an artifact false response Geba_easyTymp_Fe_12a docx 7 853 263 4 01 12 M Operating Manual MAICO easy lymp 3 Getting started 3 1 PC system requirements Processor Intel Pentium 4 Celeron 1 4 GHz Memory 1 GB RAM Graphic display 1024 x 768 Operating system Windows XP Protessional SP3 Windows 7 Professional or Ultimate Version for 32 und 64 Bit Computer Connection USB 1 1 or higher
15. ease enclose evidence of purchase with the instrument In order to ensure that your instrument works properly the tympanometer should be checked and calibrated at least once a year This check has to be carried out by your dealer When returning the instrument for repairs it is essential to also send the probe and all other accessories Send the device to your dealer or to a service centre authorized by your dealer Please also include a detailed description of the faults In order to prevent damage in transit please use the original packing if possible when returning the instrument 6 Disinfection It is recommended that parts which are in direct contact with the patient are subjected to standard disinfecting procedure between patients This includes physically cleaning and use of a recognized disinfectant Individual manufacturer s instruction should be followed for use of this disinfecting agent to provide an appropriated level of cleanliness To avoid person to person cross contamination of communicable diseases eartips should only be used one time Geba_easyTymp_Fe_12a docx 30 853 263 4 01 12 M Operating Manual MAICO easy lymp 7 Safety Regulations 7 1 Electrical safety The instrument is not to be used in environments dealing with explosive material or equipment The easyTymp is constructed to comply with protection class Type B of the international standard IEC 601 1 EN 60601 1 Protection from an electr
16. ending on the version with or without printer the cradle has up to three indication lights easyTymp LED shows solid blue when the easylymp is placed inside the cradle and the battery is fully charged The LED will flash as long as the battery is charging Battery LED shows solid blue when the spare battery in the cradle is fully charged The LED will flash as long as the battery is charging Printer LED is red when a printer problem OCCUIS Geba_easyTymp_Fe_12a docx 10 853 263 4 01 12 Operating Manual easy lymp Step 1 Push button to open the printer cover Step 2 Pull blue lever upwards Insert paper roll in the compartment with its loose end to the front of the printer Position the loose end into the printer roll and hoist it by rotating the printer roll with your finger Push blue lever down Close printer cover Geba easyTymp Fe 12a docx 11 853 263 4 01 12 M Operating Manual MAICO easy lymp 3 2 1 4 Mounting the cradle on the wall To mount the cradle on the wall is an optional wall mount kit available 3 2 1 5 Installing the easyTymp NOTE Please note that the battery needs to be charged for a minimum period of approximately 6 hours prior to first use of the easyTymp hand held tympanometer The battery compartment is opened by gently pressing the indentation and pulling the cover downwards Place the battery inside the compartment Make sure the battery contacts are corre
17. erence values for stimulus calibration Reference values Variation of Ipsi for stimulus stimulus levels for calibration different volumes of the ear canal Relative to the calibration ep performed on an IEC 126 coupler dB ISO 389 2 ISO 389 4 ISO 8798 IPSI IPSI 15 26 gt 250 14 gt 500 1000 O 55 tooo o 1500 20 2000 30 3000 35 4000 55 6000 20 8000 o we pf O Coupler types used by calibration Probe tone Is calibrated using a 2cc acoustic coupler made in accordance to IEC 60318 5 Geba_easyTymp_Fe_12a docx 37 853 263 4 01 12 M Operating Manual MAICO easy lymp Specifications are subject to change MAICO Diagnostic GmbH Salzufer 13 14 D 10587 Berlin Telefon 49 30 70 71 46 50 Telefax 49 30 7071 46 99 MAICO E mail export maico biz Internet www maico biz Geba_easyTymp_Fe_12a docx 38 853 263 4 01 12
18. he setting of the adjustable feet on the cradle and that this tool is not used for any other purpose on the easyTymp unit Attention PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE OPERATING THIS INSTRUMENT Please only use this instrument as described in the manual Please familiarize yourself with the instrument and its operation before using Should defects or damages be suspected please do not under any circumstances use or attempt to fix the instrument yourself Geba easyTymp Fe 12a docx 4 853 263 4 01 12 Operating Manual easy lymp To guarantee that the tympanometer works properly the instrument has to be checked and calibrated at least once a year The service and calibration must be performed by an authorized service centre In accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done The use of non calibrated tympanometers is not allowed Uncalibrated instruments may lead to faulty measurements and sometimes even damage the hearing of the examinee Take note to ensure that all the accessories have been properly connected To avoid person to person cross contamination of communicable diseases parts that come in direct contact with the patient i e eartips should only be used one time In accordance with the Electronic Equipment Act for disposal of electronic equipment the customer is obliged to dispose of the used consumables according to appro
19. ic shock Is ensured even without the system earth connection The instruments are not intended for operation in areas with an explosion hazard 7 2 Measurement Safety To guarantee that the tympanometer works properly the instrument has to be checked and calibrated at least once a year The service and calibration must be performed by an authorized service centre In accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done The use of non calibrated tympanometers is not allowed 7 3 Instrument Handling The instrument should be checked once a week 7 4 Operation The instrument should only be handled and operated by trained personnel audiologists ENT doctors or personnel with similar qualifications 7 5 Patient Safety Warning Do not take a test while charging the device via USB cable External equipment intended for connection to signal input signal output or other connector shall comply with relevant IEC standard e g IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment In addition all such combinations systems shall comply with the standard 60601 1 1 Safety requirements for medical electrical systems Equipment not complying with IEC 60601 shall be kept outside patient environment as defined in the standard at least 1 5 m from the patient Geba easyTymp Fe 12a docx 31 853 263 4 01 12 M Operating Manual MAICO easy
20. in the top right corner Space is found as a bar underneath the keyboard Top right button will select the next details for editing Right and Left buttons will move the selection of the keyboard one character to the left or right Up and Down 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 4 4 6 View Patients View Patients This screen shows a list of clients E Andy Andrews Some of the clients might be uploaded from your E John Doe database When one or more sessions are stored E Dick Solomon the square in front of the patients name Is filled If there is not session stored yet this square shows empty Back Details Resut Geba easyTymp Fe 12a docx 23 853 263 4 01 12 Operating Manual MAICO easylymp Operating from this screen Top left button brings you back to the Test screen Top middle button brings you to the View Details screen where the data of the selected client are shown Top right button will bring you to the View Sessions screen from where the available sessions of the selected client can be reviewed and printed Right and Left buttons will bring you to respectively the top or bottom of the client list Up and Down buttons make you move up or down one client 4 4 7 View Details This screen shows some demographics of the irst Mame Number 4 Last Nane
21. l select the highlighted character and put it where the cursor is placed Backspace is found as an arrow in the top right corner Space is found as a bar underneath the keyboard Top right button will select the next details for editing Top left button to save and return to the Setup screen 28 853 2603 4 01 12 M Operating Manual MAICO easy lymp 4 5 7 Setup Patient Management Patient Management Turns the internal patient data management Patients gn Or Off On Ab Off will delete all measured data Back Save 4 5 8 About Here you find information about firmware barsk 1 02 05 version and calibration dates Calibration Dates easylymp 26 01 2010 Probe 20 08 2010 Next Calibration 26 01 2011 Geba_easyTymp_Fe_12a docx 29 853 263 4 01 12 M Operating Manual MAICO easy lymp 5 Warranty Maintenance and Service The easyTymp is guaranteed for 1 year This warranty is extended to the original purchaser of the instrument by MAICO through the Distributor trom whom it was purchased and covers defects in material and workmanship for a period of one year trom date of delivery of the instrument to the original purchaser The tympanometer may be repaired only by your dealer or by a service centre recommended by your dealer We urgently advise you against attempting to rectify any faults yourself or commissioning non experts to do so In the event of repair during the guarantee period pl
22. manual Short user guide Standard probe configuration in Ear tip box Eartip flanged 3 5 mm 10 pieces red Eartio mushroom 7 mm 10 pieces blue Eartip mushroom 9 mm 10 pieces green Eartio mushroom 11 mm 10 pieces blue Eartip mushroom 13 mm 10 pieces green Eartip mushroom 15 mm 5 pieces blue Eartip mushroom 19 mm 5 pieces yellow Eartio umbrella 15 mm 5 pieces red Eartio umbrella 19 mm 5 pieces blue MAICO cleaning tool for probe Additional accessories for easyTymp External probe 35cm Wall Mount Kit for cradle License for high frequency probe tone of 1 kHz Cradle with integrated ear tip box power supply unit and additional rechargeable battery Cradle with integrated printer power supply unit and additional rechargeable battery Software Kit MAICO Impedance Software Consumption material Printer paper Geba easyTymp Fe 12a docx 9 853 263 4 01 12 M Operating Manual easy lymp MAICO 3 2 System installation 3 2 1 Hardware installation 3 2 1 1 Installing the cradle 1 a en rt i USBin USBout USBout USBout Power V Follow instructions for use I 6 i i Figure 1 Connectors at the rear bottom of the cradle 1 USB in 2 USB out 3 USB out 4 USB out 5 Power 6 Follow the instructions for use Put the enclosed mains cable into the power connection socket 5 and its mains plug into a power socket 3 2 1 2 Cradle indication lights Dep
23. nce 1 13 mi Gradient 56 daPa Print Geba easyTymp Fe 12a docx Operating Manual easy lymp For the selected client the screen shows a list of available sessions Operating from this screen Top left brings you back to the View Patient screen Top middle button will prompt you and ask for confirmation before it deletes the selected session or all sessions Top right button will show the selected session in the View Results screen Right and Left buttons will bring you to respectively the top or bottom of the result list Up and Down buttons move you up or down one session In this screen the test recordings of the selected session are shown Operating from this screen Top left brings you back to the View Results screen Top middle button will print all results which are stored in the selected session Top right button has no function Right and Left buttons will show the recordings of respectively the right or left ear if available Up and Down buttons make you scroll through the different tests which are included in the selected Session 25 853 2603 4 01 12 4 5 Setup Setup Language Date amp Time eas ylymp Printer Clinic Info License Patient Management About Back Select 4 5 1 Setup Language Setup Language ci Language English 4p Back Save Geba_easyTymp_Fe_12a docx Operating Manu
24. odule For installation and functions see the software manual Geba_easyTymp_Fe_12a docx 14 853 263 4 01 12 M Operating Manual AIC easy lymp 3 3 Preparing the test 3 3 1 Patient Instruction 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 Show the probe to the patient and then explain the following The aim of the test is to test the mobility of the eardrum The tip of the probe will be inserted into the ear canal and that it has to make a perfect seal A small amount of air will flow through the probe to move the eardrum it produces a sensation equal to pressing a finger slightly into the ear canal One or more tones will be heard during the test No participation is expected from the patient Coughing talking and swallowing will disturb test results 3 3 2 Visual inspection of the ear canal Check the external ear canal for wax with an otoscope and remove excessive wax to prevent the probe opening from clogging which will inhibit testing Excessive hairs may have to be cut 3 3 3 Handling the eartips Choose an ear tip of the appropriate size from the ear tip set depending on the size and shape of the ear canal and ear Put the ear tip tightly on the probe tip Always use eartips from MAICO or Sanibel Each eartip should only be used one time Geba_easyTymp_Fe_12a docx 15 853 263 4 01 12
25. patient data can be viewed and changed and earlier sessions can be reviewed and or printed This finction is only displayed if the patient management is activated Top right button will interrupt the test Stop and bring you to the Done screen Right and Left buttons will select respectively right or left ear for testing If data on one or both ears is still available the Up and Down buttons will bring you back to the done screen and allow you scroll through the measurement results Geba easyTymp Fe 12a docx 20 853 263 4 01 12 Operating Manual easy lymp 4 4 2 Select Test Screen Opens screen with available test protocols 01 Tymp 226Hz 02 Tymp kHz Preset Tymp 226Hz Auto Reflex 03 Tymp 226Hz Auto Reflex O4 Tymp 226Hz Reflex 90dE OS Tymp IkHz Auto Reflex 06 Tymp kHz Reflex 0d6 WE Option Extra software license for high frequency probe tone of 1kHz easyTymp Leads to the easyTymp Setup Select Select a test protocol and return to the test screen easylymp select Keyboard operation from this screen Top middle button brings you to the Setup screen Top right button selects the protocol of your choice and brings you to the Test screen Right and Left buttons will bring you to respectively the top or bottom of the protocol list Up and Down buttons make you move up or down one protocol 4 4 3 Done easyTymp will automatically go to the Done screen ympanogram 226 He when it h
26. priate regulation at own cost Geba_easyTymp_Fe_12a docx 5 853 263 4 01 12 M Operating Manual AIC easy lymp 2 Impedance measurements 2 1 Tympanometry Tympanometry is the objective measurement of middle ear mobility compliance and pressure within the middle ear system During the test a low pitched probe tone 226 Hz is presented to the ear canal by means of the hand held probe This tone is used to measure the change in compliance in the middle ear system while the air pressure Is varied automatically from a positive value 200 daPa to a negative value 400 daPa max 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 This is the highest peak of the curve as it Is recorded on the chart The position of the peak on the horizontal axis and on the vertical axis of the chart will provide diagnostic information regarding the function of the middle ear system Gradient calculations are reported as the Tympanogram width at half of peak compliance expressed in daPa A limits box is available on both the display 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 deca Pascals daPa NOTE 1 02 mmH20 1 0 daPa 2 2 Acoustic Reflex An acoustic retlex or contraction of th
27. properties Probe tone Frequencies Level Distortion Compliance Range Temperature dependence Pressure dependence Reflex sensitivity Temporal reflex characteristics Pressure Range Safety limits Operating Manual easy lymp 226 Hz 1 1000 Hz 1 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 Max 5 THD 0 1 to 8 0 ml 0 003 ml C 0 00020 ml daPa 0 001 ml is the lowest detectable volume change Initial latency 35 ms 5 ms Rise time 45 ms 5 ms Terminal latency 35 ms 5 ms Fall time 45 ms 5 ms Overshoot max 1 Undershoot max 1 400 to 200 daPa 750 daPa and 550 daPa 50 daPa Reflex calibration standards and spectral properties General Specifications for stimulus signals are made to follow IEC 60645 5 Ipsilateral Earphone Pure tone Wide Band noise WB Spectral properties General about levels MAICO Standard MAICO Standard As Broad band noise specitied in IEC 60645 5 but with 500 Hz as lower cut off frequency The actual sound pressure level at the eardrum will depend on the volume of the ear See Table 2 for details The risk of artifacts at higher stimulus levels in retlex measurements are minor and will not activate the retlex detection system Geba_easyTymp_Fe_12a docx 853 263 4 01 12 M Operating Manual AIC easy lymp lt O e 2 Ref
28. put for computer communication Theoretically an infinite amount of test results can be stored on the PC The easyTymp hand held unit is delivered with a 2 Gb memory card enough for storing more than a quarter of a million tests 853 263 4 01 12 M Operating Manual MAICO easy lymp Specification of output connections Outputs Transducer proprietary 12 Pin 1 pole Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 7 Pin 8 Pin 9 Pin 10 Pin 11 Pin 12 USB USB type B USB port for CH1 out CH1 GND DGND GND A 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 Interrupt communication Calibration properties Calibrated Probe system Transducers Accuracy General Retlex Frequencies losilateral Retlex Tone Levels Pressure measurement Compliance measurement Geba_easyTymp_Fe_12a docx 35 Ipsilateral Earphone is integrated in the probe system Probe frequency transmitter and receiver and pressure transducer is integrated in the probe system Generally the instrument is made and calibrated to be within and better than the tolerances required in the specified standards 3 5 dB for 500 to 2000Hz and 5 10 dB for 3000 to 4000Hz 5 or 10 daPa whichever is greater 5 or 0 1 ml whichever is greater 853 263 4 01 12 M MAICO Impedance calibration
29. rn to this screen The following 2 information can be viewed in the screen i 600 300 300 daPa Volume mi Pressure daPa Compliance ml Gradient daPa Select Test Patient Stop The header shows the status of the probe showing Ready in ear leaking or blocked In the top at the right you find status of the battery mj When the easyTymp is placed in the cradle it will charge the battery and it will show a moving charging battery icon In the upper right corner an icon shows if the easyTymp Is testing either lett ear or right ear RI 03 lymp 22642 Auto Reflex When entering the Test screen the second line shows the name of the protocol which is used As soon as easyTymp detects that the probe is in the ear the second line will show which test of the protocol Is running Y a Here you find the graphics of the ongoing test The box indicates the normative area where the peak of the tympanogram is expected under normal conditions i 600 300 300 daPa Display of the determined measurements Volume mi Pressure daPa Compliance mi Gradient daPa Geba easyTymp Fe 12a docx 19 853 263 4 01 12 M Operating Manual MAICO easy lymp Operating from this screen Putting the probe in an ear will automatically start the test Top left button will bring you into the Select Test screen from where you can select a different test protocol Top middle button will bring you to the Patient screen from where
30. s of the other ear 4 4 4 Select Patient amp Save From this screen you can either save data to an existing patient who could have been uploaded from your database or save data to a new client New patient will always get the name New Patient Number where stands for the next available number Select Pat amp Save CI New Patient Number 4 E Andy Andrews John Doe Dick Solomon Back he Save Operating from this screen Top left button will bring you back to the Done screen without saving and without deleting data Top middle button opens a screen for editing new patient details Top right button will save the data to the selected client After saving all data is deleted and easyTymp returns in the Test screen ready for testing Right and Left buttons will bring you to respectively the top or bottom of the client list Up and Down buttons make you move up or down one client Geba easyTymp Fe 12a docx 22 853 263 4 01 12 Operating Manual M MAICO easy lymp 4 4 5 Edit New With this screen you can put in data to a new client 10 First Name Last Name before saving the measurement Birth Date DD MM YYYY Operating from this screen Top left button saves the patients details and brings you back to the Select Patient amp Save Top middle button will select the highlighted character and put it where the cursor is placed Backspace is found as an arrow
31. selected client a i From here you can either use the Top left button to go back to the View Client screen or use the Top middle button to edit the client details in the Edit Details screen With the Top right button you can delete either this patient or all patients Back Edt Delete 4 4 8 Edit Details This screen shows the client ID First Name Last Edit Details Name and Birth Date NE T Top left button brings you back to the View Details Last Mame LEHM Screen Birth Date 05 07 2003 Top middle button will select the highlighted character and put it where the cursor is placed Backspace is found as an arrow in the top right A c DE L n corner Space is found as a bar underneath the ee keyboard Top right button will select the next rea details for editing Right and Left buttons will move the selection of Back Select Next the keyboard one character to the left or right Up and Down 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 Geba easyTymp Fe 12a docx 24 853 263 4 01 12 MAICO 4 4 9 View Results View Results am 14 02 2011 12 58 26 L Ol Tymp 226 Hz Back Delete View 4 4 10 View Results View Results on fF Tympanogram uf eb Hz g ann an 0 B0C 300 300 dafa Volume 1 53 mi Pressure 10 daPa Complia
32. sylymp 1 2 Safety Notes The easyTymp should always be operated in a quiet room with minimal magnetic influence to ensure that examinations are not disturbed by external noise Electro medical instruments that emit strong electromagnetic fields e g microwaves radiotherapy devices can affect the operation of the easyTymp Therefore the operation of these instruments in close proximity to the easyTymp should be avoided at all times The examination room should have a normal temperature between 15 C 59 F and 35 C 95F If the instrument has cooled down during transportation please wait for it to warm up to room temperature before operation MAICO easyTymp Is specified according to EN 60 601 1 Protection against electrical hazard is guaranteed only when the instrument is connected to a grounded safety Please note that during operation the instrument should always be connected to a battery operated or mains operated notebook computer that complies with EN 60 601 1 or EN 60 950 1 In the event that a main cable connector or wall socket is damaged please do not use the instrument under any circumstance Allen key for adjustable feet on the cradle unit An Allen key is enclosed in the packaging of the ear tip box to enable adjustment of the pair of adjustable feet located on the bottom of the cradle Please ensure that the Allen key is not permanently stored in the ear tip box that the Allen key is only used to adjust t
33. the back and pull the probe out Do not pull the cord of the extension cord as this can damage the tubing connections Geba_easyTymp_Fe_12a docx 13 853 263 4 01 12 M Operating Manual MAICO easy lymp Place the probe to the easyTymp by lining up the red triangles and pushing the probe into the unit The probe can be attached to the extension cord by lining it up correctly and clicking the probe into the end of the extension cord 3 2 1 9 Calibration cavities The easyTymp comes with a separate cavity which can be used for a quick check of the validity of the probe calibration You can use 0 2 ml 0 5 ml 2 0 ml and 5 0 ml cylinders for more extended checks To perform this check select a protocol which measures a tympanogram Do not use an ear tip Place the probe tip completely into the cavity Perform the measurement Check the volume which was measured The allowed tolerance in the volume measurement is 0 1 ml for cavities up to 2 ml and 5 for bigger cavities These tolerances count for all probe tone frequencies We strongly recommended calibrating each probe at least once a year If a probe is handled roughly e g fallen onto a hard surtace it might need to be calibrated again Calibration values of the probe are stored in the probe itself Therefore probes can be exchanged at all times 3 2 2 Optional Software You can view and store all your measurements also with the MAICO Impedance Software M
34. tus 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 to off easyTymp is pausing during a protocol and waits for you to press continue The color in which the probe light is tlashing indicates the probe status like above Flashing green to red blue easyTymp just finished the protocol 4 4 Operating easyTymp Operating the easyTymp Is very intuitive After switching on the instrument it will usually start in the Test screen and is ready to test the same protocol as was used last After disconnecting easyTymp trom a PC it will start in the Select Protocol screen and you have to select which protocol should be used The battery status bar will show if the battery power runs down If the battery Is empty you will be warned and the measurement will be stopped and all recorded data will be stored You will have to shut down and change the battery The measurement data will be recovered after you start up again In that way you can continue measurement without retesting The following paragraphs describe the precise operation of the different screens you will observe during the use of easyTymp Geba_easyTymp_Fe_12a docx 18 853 263 4 01 12 Operating Manual easy lymp 4 4 1 Test Test Ready aiL Usually the easyTymp starts with the Test Screen SNN ae ee When deleting or saving data after a measurement you will also retu
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