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Madsen zodiac, Reference Manual

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•

Annual calibration prompt

Choose when you wish to be reminded about the annual calibration.

•

Protocol saving

Choose this item if you wish to permanently save changes made to a protocol.

•

Language

Choose the language of your choice.

•

About device

Choose this item to view information relating to the device.

2.4

Communication between OTOsuite and Zodiac

1. Make sure that the device is switched on.

2. Launch OTOsuite and activate the Control Panel. MADSEN Zodiacwill be connected automatically.

2.4.1

Configuring the Immittance module

You must run the Configuration Wizard before you can use the OTOsuite Immittance module and MADSEN Zodiac for the
first time.

You can also use the wizard later to change specific settings or, for example, to connect to another device.

1. Select

Tools

>

Configuration Wizard

...

2. Click

Configure

... next to

Immittance

.

3. Enter your selections and click

Next

to continue the configuration or

Finish

to return to the

Applications

page of the

configuration wizard.

Immittance

Select Immittance Device

1. Click to highlight the device you wish to use.

2. Click

Next

to continue or

Close

to exit Immittance configuration.

2.4.2

Test device information

In OTOsuite

To see information relating to the test device, select

Help

  >

About Device

... in the OTOsuite Immittance module.

In Zodiac

Menu

 > (missing or bad snippet) >

About Device

Otometrics - MADSEN Zodiac

17

2 Unpacking and installation

Summary of Contents for zodiac

Page 1: ...MADSEN Zodiac Reference Manual Doc No 7 50 1610 EN 02 Part No 7 50 16100 EN...

Page 2: ...ed Otometrics the Otometrics Icon AURICAL MADSEN ICS and HORTMANN are registered trademarks of GN Otometrics A S in the U S A and or other countries Version release date 2016 10 06 143849 Technical su...

Page 3: ...t in printer 18 4 Views of Zodiac 20 4 1 Front view 20 4 2 Bottom view 21 5 The Zodiac probes 22 5 1 The Quick Check probe 22 5 2 The diagnostic probes 24 5 2 1 The diagnostic probe and shoulder strap...

Page 4: ...9 10 ETF P 70 9 10 1 The ETF P screen 71 10 The OTOsuite Immittance module 73 10 1 OTOsuite toolbar icons and control panels 73 10 2 Shortcut keys 78 10 3 Leakage and other probe problems 80 11 Testi...

Page 5: ...the probe and probe tip 120 17 4 5 Fitting a new probe tip 122 17 4 6 Cleaning the test cavities 123 17 4 7 Cleaning the printer 123 17 4 8 Disposable accessories 124 18 Standards and safety 125 18 1...

Page 6: ...156 App 2 5 3 B G 156 App 2 5 4 157 App 3 Immitanz beim MADSEN Zodiac Methodologie und Funktionen 158 App 3 1 Tympanometrie eine Einf hrung 158 App 3 1 1 Tympanometrieuntersuchung 158 App 3 2 Tympano...

Page 7: ...5 2 Tympanom trie 179 App 5 2 1 Tests de tympanom trie sur des nourrissons 179 App 5 2 2 Fonctions de tympanom trie 180 App 5 2 3 ETF I Fonction de la trompe d Eustache Intacte 181 App 5 2 4 Manoeuvr...

Page 8: ...ammettenza 193 App 6 4 ETF P Funzione della tromba di Eustachio Perforata 194 App 6 5 Suscettanza e Conduttanza B G 194 App 6 5 1 Suscettanza B 195 App 6 5 2 Conduttanza G 196 App 6 5 3 Visualizzazio...

Page 9: ...ee Testing with Zodiac Diagnostic or Clinical PC based 86 Supported tests Depending on the configuration Zodiac supports the following tests and functionalities Tympanometry Quick Check Diagnostic Cli...

Page 10: ...in the Noah database via OTOsuite Printing test results Some versions of MADSEN Zodiac have a built in thermal printer for printing test results When MADSEN Zodiac is used in connection with the OTOs...

Page 11: ...e air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear This device is also use...

Page 12: ...s and viewing and printing test results We recommend that you read this manual and make yourself familiar with MADSEN Zodiac and how it operates with OTO suite so that you become familiar with the dev...

Page 13: ...f the device or software the manual uses pre cautionary statements as follows Warning Indicates that there is a risk of death or serious injury to the user or patient Caution Indicates that there is a...

Page 14: ...kage is incomplete contact your local distributor 2 2 Storing If you need to store MADSEN Zodiac before you put it into operation follow the guidelines below Store MADSEN Zodiac and accessories in the...

Page 15: ...external power supply to the mains supply 1 Connect the mains plug of the external power supply directly to an AC mains outlet with a three wire protective ground 2 If applicable switch on the mains...

Page 16: ...are module automatically detects the device 2 3 4 Configuring the device Before you start using Zodiac you can configure the general device settings Accessing the device settings Press the Menu button...

Page 17: ...suite Immittance module and MADSEN Zodiac for the first time You can also use the wizard later to change specific settings or for example to connect to another device 1 Select Tools Configuration Wiza...

Page 18: ...the printer cover into place until the lock clicks shut Loading a new paper roll Warning When you open the paper compartment be careful not to injure your hands on the cutter blades Caution Use only...

Page 19: ...closing the cover you will see the Otometrics watermark 6 Tear off the part of the paper where glue has held the roll together 7 Make sure that the loose end of the paper roll emerges through the pap...

Page 20: ...m view 21 Zodiac Stand alone You will find a description of the front panel controls in MADSEN Zodiac test controls 28 4 1 Front view Stand alone A Display B On off switch C Front panel D Dial diagnos...

Page 21: ...4 2 Bottom view A Probe connections B Label Otometrics MADSEN Zodiac 21 4 Views of Zodiac...

Page 22: ...ear first and change eartips before you test the other ear The immittance probes MADSEN Zodiac supports the following types of immittance probes The Quick Check probe 22 The diagnostic probes 24 At de...

Page 23: ...obe 38 Cleaning the probe and probe tip 120 Warning Always fit an eartip on the probe before inserting it into the ear of the patient Warning The eartip can be used for both ears If you suspect infect...

Page 24: ...eflex measurements and combined with the use of a con tralateral phone Depending on the configuration of the device Zodiac Diagnostic and Zodiac Clinical are delivered with a diagnostic probe already...

Page 25: ...or hanging shoulder strap C Diagnostic probe D Control pad E Contralateral phone F Probe cable connections Probe cable connections A The diagnostic probe connection The diagnostic probe is permanently...

Page 26: ...ostic probe you can easily switch between using the two probes If the probe you wish to use is not activated press any one of the buttons on the probe to activate it 5 2 3 The contralateral phone If y...

Page 27: ...itably sized foam eartip on the contralateral insert phone 2 Before inserting the eartip in the patient s ear com press the foam eartip to make it smaller Insert the eartip in the patient s ear until...

Page 28: ...buttons Starting and ending a session New Session Press this button to create a new session Report The function of this button depends on the configuration of the system Zodiac with a built in printer...

Page 29: ...ton to delete individual measurements Probe check Probe check Place the probe in the probe check cavity and press this button to carry out a probe check On screen selections Soft button Press this but...

Page 30: ...ons C Running tests D On screen selections Depending on the configuration of the stand alone version of Zodiac the front panel has a range of function buttons a dial and three soft buttons Starting an...

Page 31: ...kHz 1 kHz 2 kHz 4 kHz Noise stimulus Press this button to select Broadband noise as a reflex stimulus P pressure offset Press this button to select a pressure offset to stabilize the eardrum This may...

Page 32: ...Start Stop This button is placed both on the device and on the diagnostic probe shoulder strap This button is lit while a test is running Press this button to perform a tympanometric measurement to st...

Page 33: ...easurement functions you can use the dial to scroll between menu items on the screen 6 3 The Zodiac menu If you use a stand alone version of Zodiac you can use the function specific buttons to activat...

Page 34: ...Device Settings Protocol Set tings and set to Allowed If you switch off Zodiac after changing and saving the test settings the protocol will be locked again If you wish to save the changed protocol s...

Page 35: ...Exiting the Special Tests menu Press the Cancel soft button to exit the Special Tests menu Zodiac returns to Tympanometry mode Otometrics MADSEN Zodiac 35 6 MADSEN Zodiac test controls...

Page 36: ...any established infection control procedures for the setting in which you are working Always use clean eartips Swab the probe tip with disinfectant between ears If one ear is infected test the health...

Page 37: ...hows a value of 1 9 2 1 mmho cc ml at 226 Hz the probe is OK If not we recom mend that you make an admittance calibration Additional probe admittance checks can be performed See the MADSEN Zodiac Refe...

Page 38: ...ted Click to open the Test Selector window This window enables you to load user defined tests special test setups and factory default tests 7 6 Inspecting the patient s ear 1 Position the patient so t...

Page 39: ...he eartip on the probe 1 Firmly push and twist the eartip onto the probe tip until it rests firmly against the base of the probe tip Removing the eartip To remove the eartip grasp the stem of the eart...

Page 40: ...applying excessive force may cause unnecessary discomfort to the patient Premature babies newborns and infants Warning Be careful not to insert the probe too far into the ear canal of premature babies...

Page 41: ...l the pinna upwards and back For infants and children pull the pinna down wards and back 7 Insert the probe in the patient s ear canal while twisting the probe gently When the probe is in place remove...

Page 42: ...his will be shown on the OTOsuite screen If you are using the Quick Check probe the leakage indication will remain until you remove the probe from the ear and try again Probe blocked Stand alone If th...

Page 43: ...e 2 If the ear canal is blocked this may affect the result of the test Clean the ear canal if needed Caution The probe can be damaged if fluids enter the probe Warning Always fit the probe with a new...

Page 44: ...l interrupt the test The probe will indicate if there is a leak When you get a leak detection signal you must briefly remove the probe from the ear before try ing again 8 Make sure that the eartip fit...

Page 45: ...he OTOsuite screen If you are using the Quick Check probe the leakage indication will remain until you remove the probe from the ear and try again Probe blocked Stand alone If the probe is blocked dur...

Page 46: ...Tympanometric curves Pressure and admittance scales Ear canal volume bar The ear canal volume is shown to the right of the graph Norm area C Reflex Screening results The detected reflex is shown in t...

Page 47: ...cessary E On screen selections Curve selection Press the Previous Curve or Next Curve softbutton to select the desired curve in the Reflex Screening and Tympanometry result tables Manually adjusting t...

Page 48: ...tympanometry testing and continues automatically from tympanometry to reflex screening Note The safety intensity level cannot be exceeded in screening mode Note You can use either ordinary eartips or...

Page 49: ...Ask the patient to sit very still and quiet during the test without moving head or jaw The Quick Check probe 4 Press the probe against the patient s ear canal so that a hermetic seal is achieved The...

Page 50: ...all times if you are using the diagnostic probe Probe color Status Red The right test ear has been selected The device is in idle mode Blue The left test ear has been selected The device is in idle mo...

Page 51: ...rmed real time on the screen A On line values B Tympanometry graph C Reflex Screening results D Tympanometry results E On screen selections A On line values The on line values show the current setting...

Page 52: ...sequently change it manually if necessary E On screen selections Curve selection Press the Previous Curve or Next Curve softbutton to select the desired curve in the Reflex Screening and Tympanometry...

Page 53: ...ted or the probe is removed from the patient s ear the sequence stops automatically 1 To stop the test manually press the Start Stop button 2 If the patient is troubled by the test press the Start Sto...

Page 54: ...ot activated the probe light is not lit activate the probe The diagnostic probe Press the Ear button on Zodiac or the Start Stop button on the control pad The Quick Check probe Press the Ear button on...

Page 55: ...ish to overwrite a tympanogram use the dial or the soft buttons Previous Curve or Next Curve to select the curve you wish to overwrite When you have finished testing one ear switch ears if needed View...

Page 56: ...a reflex is not detected the highest stimulus is displayed together with a No Response indication If the system cannot automatically analyze a reflex measurement a Not Tested indication is shown D Tym...

Page 57: ...single measurement Results shown The results are shown as a tympanometric curve traced over the norm area if Norm Area is enabled The tympanogram can be viewed in four different ways traditional abso...

Page 58: ...coustic reflex testing MADSEN Zodiac determines acoustic reflexes automatically using different stimulus levels Note It is recommended that you perform a tympanometric test before making any acoustic...

Page 59: ...d Reflex Threshold automatically follows the tympanometry sweep if you start the Tymp Reflex Threshold sequence see Sequence testing 52 Note It is recommended that you perform a tympanometric test bef...

Page 60: ...has started 13 If needed you can offset the pressure to stabilize your measurements Press and hold the P pressure offset button and use the dial to set the desired pressure 14 If needed repeat these s...

Page 61: ...and status Probe tone in Hz Stimulus side Ipsi is the probe ear and Contra is the opposite ear Stimulus frequency Stimulus level Current pressure and admittance scales Reflex Threshold deflection curv...

Page 62: ...reathing This is a sign of Eustachian tube dysfunction and may prevent further reflex testing Variations due to a very steep tympanogram for example seen in excessively flaccid tympanic membranes This...

Page 63: ...forming the test Note When you select a special test the Special button will remain lit until you deselect the special test e g by pressing the Tymp button or by pressing the Special button a second t...

Page 64: ...ss the Special button 2 Select Reflex Decay 3 The Reflex Decay view is shown and the preselected settings for reflex decay will light up on the buttons e g Contra 0 5 k Hz 4 Use the dial to set the st...

Page 65: ...Already measured results are kept when a measurement is stopped 9 7 1 The Reflex Decay screen A On line values B Reflex Decay graph C Reflex Decay results table D On screen selections On line values T...

Page 66: ...esult is ambiguous you can hide a half life time marker Alternatively you can show the marker Done When you have adjusted the marker press the Done soft button The results table is updated with the se...

Page 67: ...lts 6 To view tympanometry results see The Manual Tympanometry screen 67 7 When you have finished testing see Managing test results in MADSEN Zodiac 111 9 8 1 The Manual Tympanometry screen A On line...

Page 68: ...dmittance Y Recorder Admittance Y Recorder is a functionality where you can record the admittance either without stimulus or with any external stimulus The functionality can be useful both for investi...

Page 69: ...sitivity by several dB Use the pressure offset button P to select a pressure offset to stabilize the eardrum Keep the button depressed and use the dial to select the desired pressure Before testing 1...

Page 70: ...en A Admittance Recorder graph Admittance Recorder graph Time line in seconds The recorded admittance graph shown in the left graph area The live baseline graph shown in the right graph area 9 10 ETF...

Page 71: ...ire middle ear See Tympanometry testing 88 2 Press the Special button 3 Scroll to select the ETF P test 4 Press the OK soft button 5 If needed use the dial to adjust the initial pressure 6 Press the S...

Page 72: ...essure markers manually if needed ETF P results table The results table shows the Eustachian tube openings in daPa The pressure values denoting the openings and closings of the Eustachian tube are det...

Page 73: ...rsion A Starting and ending a session B Measurement selections and carrying out tests C Viewing test data D Editing results E Selecting other test types Tympanometry and Reflex Screening Diagnostic an...

Page 74: ...ctivate the test or test setting you wish to use The button turns yellow to indicate that the function is active Deactivate test functions Click to deactivate the test or test setting you do not wish...

Page 75: ...ecordings from ears that have steeply sloped tympanograms Set stimulus type Click the desired arrow to set the stimulus type Set stimulus level Click the desired arrow to increase or decrease the stim...

Page 76: ...the sequence You can choose if you want to start sequences or individual tests on the shoulder pad Screening sequence Tympanometry Reflex Screening Diagnostic sequence Tympanometry Reflex Threshold R...

Page 77: ...ally to present stimuli for manual reflex testing During a test click or press this button to stop the test Present stimulus manually Click to make a manual reflex threshold Start recording Admittance...

Page 78: ...sired test type Tymp and Reflex Scr Reflex Threshold Admittance Recording ETF P Manual Tymp 10 2 Shortcut keys General Function Shortcut Sequence panel Manual panel S toggle Probe tone P cycle User te...

Page 79: ...st pressure negative Shift Arrow down 500 Hz 5 1000 Hz 1 2000 Hz 2 4000 Hz 4 Noise N Reflex Decay Function Shortcut Start measurement F5 Spacebar Stop measurement F5 Esc Level up Arrow up Level down A...

Page 80: ...leakage or probe problems missing or bad snippet missing or bad snippet Leakage and probe occlusion is shown on the screen during testing Probe status The light indicators Light indicators light up in...

Page 81: ...you are using the Quick Check probe the leakage indication will remain until you remove the probe from the ear and try again Probe blocked Stand alone If the probe is blocked during testing this will...

Page 82: ...form an otoscopy to assess the status of the outer ear before you insert the probe 2 If the ear canal is blocked this may affect the result of the test Clean the ear canal if needed Caution The probe...

Page 83: ...A flat tympanogram together with an abnormally small ear canal volume ECV indic ates that the probe is blocked A measurement will not autostart if the ear canal volume reading is less than 0 1 6 Any l...

Page 84: ...his will be shown on the OTOsuite screen If you are using the Quick Check probe the blocked probe indication will remain until you remove the probe from the ear and try again 11 2 The Quick Check meas...

Page 85: ...ether with a No Response indication D Tympanometry results The results table shows the results related to the currently selected curve Probe the probe tone in Hz TPP Tympanometric Peak Pressure ECV Eq...

Page 86: ...how to use and view them in Quick Check testing 87 Tympanometry testing 88 Reflex Threshold testing 93 Reflex Decay testing 98 Admittance Y Recorder 103 ETF P 106 Manual Tympanometry 101 12 1 Sequenc...

Page 87: ...rt and then restart the sequence testing 12 2 Quick Check testing You can perform Tympanometry and Reflex Screening as a Quick Check test from the Tymp Reflex Screening screen Note The safety intensit...

Page 88: ...wn wards and back 6 Insert the probe in the patient s ear canal while twisting the probe gently When the probe is in place remove your hands carefully Diagnostic probe placement 7 Make sure that the e...

Page 89: ...Click the Tymp and Reflex Scr tab on the screen 1 Click the Tymp button on the control panel 2 Place the probe in the patient s ear 3 Ask the patient to sit very still and quiet during the test withou...

Page 90: ...Zodiac 111 12 3 1 The Tympanometry screen When the measurement starts you will see the measurement being performed real time on the screen A Control panel selections B Tympanometry graph C Results ta...

Page 91: ...ve You can set the type to be determined automatically and you can subsequently change it manually if necessary Primary tympanograms The most recently recorded tympanogram is by default set as the pri...

Page 92: ...by keeping the pressure between measurements 12 5 Acoustic reflex testing MADSEN Zodiac determines acoustic reflexes automatically using different stimulus levels Note It is recommended that you perf...

Page 93: ...ically suggests the threshold level Always carefully review this result and adjust it if necessary Manual Reflex Threshold testing see Manual Reflex Threshold testing 93 Automated Reflex Threshold tes...

Page 94: ...warning limit 8 Click the Present button to present a single stimulus The deflection curve is plotted in real time 9 If needed repeat these steps until you have collected the desired meas urements Th...

Page 95: ...ns for the automated reflex sequence have been selected They include starting level increment size veri fication procedure and maximum level As opposed to a full measurement sequence the automated thr...

Page 96: ...Live baseline graph C Tympanogram D Threshold data table A Reflex Threshold deflection curves The graph area shows the reflex deflection curves the associated level and numerical deflection values Ref...

Page 97: ...Variations due to a very steep tympanogram for example seen in excessively flaccid tympanic membranes This problem can usually be remedied by slightly offsetting the air pressure from the tympanometr...

Page 98: ...upra threshold test where the stimulus levels are very high for an exten ded period of time Make sure that there are no contraindications for performing the test Note It is recommended that you perfor...

Page 99: ...t button to start the test for the preset stimulus 8 If needed repeat these steps until you have collected the desired meas urements Warning If the patient is troubled by the test stop the test The te...

Page 100: ...rom the tympanometric peak pressure Variations that are in synchrony with the patient s pulse or breathing may prevent the measurements from being suc cessful You can use the Admittance Recording test...

Page 101: ...start the measurement adjust the starting pressure by using the slider below the graph 4 If needed click the checkbox to reset the pressure to 0 daPa after the measurement 5 Click the Start Stop butto...

Page 102: ...ement being performed real time on the screen A Ear selection B Probe tone in Hz C Tympanometry graph D Results table A Ear selection The selected measurement ear B Tympanometry graph The graph area s...

Page 103: ...lity where you can record the admittance either without stimulus or with any external stimulus The functionality can be useful both for investigative purposes and troubleshooting in conjunction with u...

Page 104: ...op button to start recording 6 If needed press the P pressure offset button and simultaneously use the dial to adjust the pressure Warning If the patient is troubled by the test stop the test The test...

Page 105: ...essure and admittance scales B Admittance Recorder graph Time line in seconds The recorded admittance graph shown in the left graph area C Live baseline graph The live baseline graph shown in the righ...

Page 106: ...ualization through the tube will show as a sudden pressure drop toward but not necessarily reaching atmospheric pressure 0 daPa This is repeated until the pressure is equalized or until the test is st...

Page 107: ...tive target pressure When the measurement starts you will see the measurement being performed real time on the screen One curve per ear is saved A Measurement selections B ETF P graph C Results table...

Page 108: ...arker you delete the pair Add Markers The opening marker which consists of an opening and a closing marker is placed in the graph You can drag the marker to adjust the position If needed click and dra...

Page 109: ...mpanograms from different test dates for display in the central view area The tym panograms illustrate changes over time to the middle ear function The Tympanogram History screen showing tympanograms...

Page 110: ...The Tympanogram History screen showing tympanograms selected for comparison 110 Otometrics MADSEN Zodiac 12 Testing with Zodiac Diagnostic or Clinical PC based...

Page 111: ...ions in OTOsuite see the OTOsuiteUser Guide or OTOsuiteReference Manual Deleting measurements 1 You can delete a single measurement curve by using the soft button functions Previous Curve or Next Curv...

Page 112: ...g from the built in printer 1 If the device is configured to print directly from the built in printer press the Report button to print out the test res ults You can use the dial to scroll through the...

Page 113: ...can transfer data from Zodiac to a PC with OTOsuite installed Transferring data to OTOsuite If you need to change the patient in OTOsuite while you are working with OTOsuite you can fetch the patient...

Page 114: ...rint function to print a test report See the OTOsuite User Guide Tympanometry Click the checkboxes in the View column to select or deselect the curves you wish to include in the test report 114 Otomet...

Page 115: ...cannot be used by others until it has been serviced Warning For the sake of safety and in order not to void the warranty service and repair of electro medical equipment should be carried out only by t...

Page 116: ...device and the probes are delivered fully calibrated The device is calibrated from the factory in dB SPL or dB HL using the stated reference equivalent thresholds dB HL are related to sound pressure l...

Page 117: ...om MADSEN Zodiac switch on the device and select Special Calibration Probe Admit tance 3 Select the probe type you wish to cal ibrate Quick Check or Diagnostic 4 When the probe light indicator shows t...

Page 118: ...the device is a Zodiac Diagnostic or a Zodiac Clinical use a thin cloth with a recommended cleaning agent to gently the clean the area beneath it If needed use a screw driver torq IP6 to carefully uns...

Page 119: ...2 Cleaning the device Caution Use only the cleaning agents prescribed for cleaning the device Procedure Warning Keep the unit away from liquids Do not allow moisture inside the unit Moisture inside t...

Page 120: ...ly for MADSEN Zodiac by Oto metrics Ear canal debris blocking the probe tubes can lead to abnormally large ear canal volume readings leak messages and other odd results Check the channels of the probe...

Page 121: ...st the probe ring slightly counter clockwise This will loosen the probe tip Caution Even the slightest amount of mois ture may dissolve any residual cerumen and thus contaminate the sensitive parts in...

Page 122: ...to the probe A Sound channels 4 Fit the probe tip on the probe and twist the probe ring clockwise to lock the probe tip in place on the probe Probe check If you have fitted a new probe tip do a probe...

Page 123: ...be tip do a probe check See Probe check 36 17 4 6 Cleaning the test cavities If a test cavity becomes contaminated do not use it Dispose of it and replace it with a new one 17 4 7 Cleaning the printer...

Page 124: ...to another Disposable accessories should not be cleaned or re used Always throw away disposable accessories after use on a patient Eartips To prevent cross infection use new eartips when you test the...

Page 125: ...user manual for warnings and cautions Complies with Type BF requirements of IEC60601 1 Complies with Medical Devices Directive 93 42 EEC and RoHS Directive 2011 65 EC Complies with the Radio Equipment...

Page 126: ...entilated space as this may affect the performance of the device If it is stacked or placed adjacent to other equipment make sure that the operation of the device is not affected 9 Do not store or ope...

Page 127: ...IEC 60950 When selecting accessories connected to the device the following points must be considered Use of connected equipment in a patient environment Proof that connected equipment has been tested...

Page 128: ...ns re adjustments modifications or repairs are carried out by the equipment man ufacturer or personnel authorized by the manufacturer The electrical installation to which the equipment is connected co...

Page 129: ...as been performed at the alti tude where the device is to be put into operation Acoustic reflex Sensitivity Reflex Threshold and Reflex Decay 0 01 0 02 0 03 0 04 or 0 05 mmho Reflex Screening 0 04 mmh...

Page 130: ...For probe tones above 226 Hz artifacts may start to occur at levels above 105 dB HL THD 5 for levels below 110 dB HL 10 for levels above 110 dB HL Range BBN LPN HPN at 50 to 110 dB SPL 3 dB measured i...

Page 131: ...e Bandwidth 400 4000 Hz Tolerance 5 dB re 1 kHz level Slope Spectrum level drops between 4000 and 7000 Hz and remains below 23 dB re 1 kHz level for frequencies above 7000 Hz Level Noise level is indi...

Page 132: ...x stimulus RETSPL values Frequencies Hz Ipsilateral probe HA 1 2 Insert phone HA 1 2 Insert phone HA 2 2 Supra aural phone IEC 60318 3 NBS 9A 1 Supra aural phone IEC 60318 1 1 500 6 0 6 0 5 5 11 5 13...

Page 133: ...utput 24 V 2 5 A Input 100 240 V AC 50 60 Hz 1 5 A Power consumption Power consumption 70 VA Operating environment Temperature 15 C to 35 C 59 F to 95 F Air humidity 10 to 90 non condensing Air pressu...

Page 134: ...on 2 65 kg 5 85 lb PC based version 1 65 kg 3 64 lb Optional features Stand alone Printer Built in printer Prints 832 dot line s on 112 mm paper width 2 cc coupler Calibration Equipment should be cali...

Page 135: ...Type BF IPX0 EMC EN 60601 1 2 Impedance Admittance Clinical Diagnostic EN 60645 5 Type 1 ANSI S3 39 Type 1 Quick Check EN 60645 5 Type 2 ANSI S3 39 Type 2 Power supply Class I externally powered supp...

Page 136: ...strap hook Probe home for Quick Check probe wall mounted or device mounted 2 cc cavity for probe check Multi frequency cavity kit OTOsuite SW installation disk Power cord MADSEN Zodiac User Guide MAD...

Page 137: ...tended for use in the electromagnetic environment specified below The user of MADSEN Zodiac should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Ele...

Page 138: ...ers as determ ined 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 equipment marked with this symbol Ra...

Page 139: ...to 800 MHz d 1 2 800 MHzto 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommen...

Page 140: ...of air pressure or muscle activity applied The maximum acoustic energy admittance the point at which the most acoustic energy enters the middle ear is obtained when the middle ear mobility is maximiz...

Page 141: ...anometry e g size increase of the external ear middle ear cavity and mastoid a change in the orientation of the tympanic membrane fusion of the tympanic ring a decrease in the overall mass of the midd...

Page 142: ...uivalent Ear Canal Volume ECV is measured as the com pliance at 200 daPa ear canal pressure Accordingly the ECV is only shown when a 226 Hz probe tone is used When using a higher frequency probe tone...

Page 143: ...ization of negative pressure will displace the tympanometric peak in a positive direction in the tym panogram It is less common with standing positive pressure in the middle ear due to the anatomical...

Page 144: ...cific In case of baseline instability due to a hyper flaccid eardrum a pressure offset of 20 30 daPa in the same direction as TPP displacement may be used A pressure offset of this magnitude will stab...

Page 145: ...ocochlear pathology The two different time criteria have been used by different researchers The acoustic reflex is more prone to adaptation with higher stimulus frequencies Accordingly adaptation to t...

Page 146: ...e vector length derived from the Cartesian graph as shown App 1 5 1 Susceptance B Susceptance is determined by the ease with which energy flows through the Compliant elements of the ear and the ease o...

Page 147: ...r canal Susceptance This Susceptance is mainly Compliance Susceptance since the Mass element in this enclosed air is negligible The value of the notch in the Susceptance tympanogram can then be determ...

Page 148: ...eep including the extreme point where the ear canal admittance is determined Using higher frequency probe tones The covariation between Susceptance and Conductance is no longer true when the probe ton...

Page 149: ...ge is due to a change in Mass or Compliance contribution it is still an absolute change rel ative to the ear canal admittance reference point Otometrics MADSEN Zodiac 149 App 1 MADSEN Zodiac immittanc...

Page 150: ...ho MADSEN Zodiac 226 Hz l l 1000 App 2 2 1 2000 Margolis Hunter Acoustic Immittance Measurements R J Roeser M Valente H Hosford Dunn Eds Audiology Diagnosis 2002 T L Wiley D T Stoppenbach Basic Princi...

Page 151: ...App 2 2 1 4 6 1000 Hz 1000 Hz 4 226 Hz 226 Hz 1000 Hz App 2 2 2 TPP TPP SA SA 200 daPa SA 226 Hz SC SA Note SA ANSI S3 39 1987 Ytm Otometrics MADSEN Zodiac 151 App 2 MADSEN Zodiac...

Page 152: ...TW TW TW SA 2 TW daPa Y X Fig 3 ECV ECV 200 daPa ECV 226 Hz EBV ECV Fig 4 A 226 Hz Jerger Note Ad As B C SA TPP 100 daPa D 152 Otometrics MADSEN Zodiac App 2 MADSEN Zodiac...

Page 153: ...odiac Jerger 226 Hz A Ad As B C B As 100 50 daPa 0 3 1 7 mmho App 2 2 3 ETF I ETF I ETF I Valsalva Toynbee App 2 2 4 Valsalva 0 daPa 15 daPa App 2 2 5 Toynbee App 2 3 Otometrics MADSEN Zodiac 153 App...

Page 154: ...P 20 30 daPa Bell 154 154 App 2 3 1 1000 Hz 226 Hz 1000 Hz App 2 3 2 0 02 mmho 15 20 dB App 2 3 3 500 Hz 1000 Hz 10 dB 10 226 Hz 50 50 5 10 500 Hz 1000 Hz App 2 3 4 154 Otometrics MADSEN Zodiac App 2...

Page 155: ...App 2 4 ETF P ETF P ETF P ETF P 0 daPa 50 daPa s ETF P 400 daPa 600 daPa App 2 5 B G Y B G App 2 5 1 B Otometrics MADSEN Zodiac 155 App 2 MADSEN Zodiac...

Page 156: ...jB jB App 2 5 2 G App 2 5 3 B G B G Y B G B G 156 Otometrics MADSEN Zodiac App 2 MADSEN Zodiac...

Page 157: ...App 2 5 4 226 Hz 226 Hz 200 daPa Otometrics MADSEN Zodiac 157 App 2 MADSEN Zodiac...

Page 158: ...vit t Die maximale Admittanz akustischer Energie d h der Punkt an dem die meiste akustische Energie in das Mittelohr gelangt wird erreicht wenn die Mobilit t des Mittelohrs am gr ten ist Dies ist dann...

Page 159: ...angen dass eine Anzahl von Entwicklungsaspekten in den ersten Lebensmonaten die akustischen Reaktionseigenschaften des Mittelohrs von Kleinkindern wesentlich ndert und die Tympanometrie beeinflusst Gr...

Page 160: ...1987 Tympanometrische Weite TW Die Tympanometrische Weite TW stellt ein Ma f r die Sch rfe oder Steilheit des Tympanogramms dar TW ist die Kurvenweite bei der halben H he der Kurve SA 2 TW wird in daP...

Page 161: ...zungen der statischen Admittanz 0 3 bis 1 7 mmho App 3 2 3 ETF I Eustachische R hrenfunktion Intakt ETF I wird bestimmt um zu untersuchen wie gut das Mittelohr durch die Eustachische R hre bel ftet wi...

Page 162: ...akustische Energiefluss durch das Mittelohr vermindert Das Sondenmikrofon erkennt diese nderung da die im Geh rgang verbleibende akustische Energie gr er wird Das resultierende Diagramm zeigt die Adm...

Page 163: ...1000 Hz Sondenton ipsilateraler Stim ulation und einem Breitbandrauschen Stimulus empfohlen App 3 3 2 Stapediusreflexschwelle Die Reflexschwelle ist der niedrigste Stimuluspegel bei dem ein messbarer...

Page 164: ...tachischen R hre in Ohren mit perforiertem Trommelfell ETF P wird eine andere Methode als die Immittanzmessung genutzt Bei ETF P wird der Luftdruck laufend berwacht um jede Luftstr mung durch die Eust...

Page 165: ...massen in den Mastoidluftzellen des Mittelohrs sie bewegen sich einheitlich ohne Kompression und Expansion Die Beitr ge von Komplianz und Masse zur Gesamt Suszeptanz sind frequenzabh ngig Die komplian...

Page 166: ...ie der als W rme aufgrund von Reibung im H rapparat verloren geht Reibung entsteht durch den Kontakt zwischen sich bewegenden Molek len im System Die Konduktanz steigt typischerweise wenn mehr Energie...

Page 167: ...immt wenn man sich dem Spitzendruck n hert bleibt die Beziehung zwischen der Suszeptanz und der Konduktanz ber den Druckwechsel hinweg nicht dieselbe Sobald dies eintritt k nnen Sie nicht l nger die G...

Page 168: ...entes can tidades de energ a ac stica restante en la sonda dependiendo de la cantidad de presi n de aire o de la actividad de m s culo aplicada La admitancia de la energ a ac stica m xima el punto en...

Page 169: ...ra los o dos infantiles Se cree que un n mero de aspectos de desarrollo a trav s de los primeros meses de vida alteran significativamente las propiedades de respuesta ac stica del o do medio del ni o...

Page 170: ...m trica TW proporciona una medida de la nitidez o la pendiente del tim panograma TW es la anchura de curva a media altura de la curva SA 2 TW se mide en daPa seg n la ilustraci n de abajo Y Admitancia...

Page 171: ...diciones Las presiones pico tim panom tricas del timpanograma se comparan para evaluar si la ecualizaci n de presi n es exitosa o no En general la gente tiene una presi n de o do medio ligeramente neg...

Page 172: ...e del canal del o do aplicada cor respondiente a la presi n pico timpanom trica Consulte Funciones timpanom tricas 169 Siempre realice la timpanometr a antes de evaluar el reflejo ac stico La presi n...

Page 173: ...a de reflejo ac stico La prueba de adaptaci n de reflejo ac stico se utiliza para investigar si se puede mantener la contracci n del m sculo esta pedio durante la estimulaci n prolongada Un est mulo d...

Page 174: ...ortan como los resultados de la prueba Com nmente una incorporaci n inicial de presi n positiva ocasionar que se abra la trompa de Eustaquio espont nea mente Para evitar la ecualizaci n de presi n esp...

Page 175: ...do Compensaci n esencial Para cuantificar la Susceptancia del o do medio es til compensar la curva de Susceptancia Esto se logra a trav s de la sus tracci n de la Susceptancia del canal del o do La m...

Page 176: ...frecuencia como la de 226 Hz La raz n es que el o do medio es com nmente controlado por la rigidez a 226 Hz y de acuerdo a esto los elementos de Masa del o do medio no tendr n influencia sobre la curv...

Page 177: ...egativa los valores de admitancia en la curva de admitancia de com pensada por componente siempre tendr un valor positivo en toda la curva e incluso un timpanograma de admitancia con corte no compensa...

Page 178: ...donc de la pression de l air dans le conduit auditif mais galement de l activit des muscles qui bloquent la mobilit de l oreille moyenne L admittance maximale de l nergie acoustique le point pour lequ...

Page 179: ...ne fr quence de 1000 Hz est pr conis e pour plusieurs raisons entre autres afin d viter l apparition de fr quences r sonnantes basse fr quence caract ristiques des oreilles du nourrisson De nombreux f...

Page 180: ...se Lorsqu un tympanogramme de 226 Hz est affich en unit s de volume le terme Compliance Statique SC remplace SA Note L admittance statique SA est gale la valeur admittance acoustique statique compens...

Page 181: ...nificative Valeurs limites de pression de 100 50 daPa Valeurs limites d admittance statique de 0 3 1 7 mmho App 5 2 3 ETF I Fonction de la trompe d Eustache Intacte Le test ETF I s effectue afin de v...

Page 182: ...us s par plusieurs stimulations avec des tonalit s pures et variables ou par du bruit filtr Lorsque le muscle stap dien se contracte la tension de la cha ne ossiculaire augmente la rigidit de l oreill...

Page 183: ...iveaux de stimulation normaux par rapport un audiogramme tonalit pure il est recommand d effectuer une s rie de tests com plets de seuil de r flexe acoustique Test chez le nourrisson Il est galement p...

Page 184: ...Eustache apr s une tympanoplastie L air doit en effet pouvoir passer par la trompe d Eustache apr s une op ration de chirurgie reconstructive afin d quilibrer la pression dans l oreille moyenne Une m...

Page 185: ...se d pla ant individuellement sans compression ni expansion La contribution de chaque l ment de compliance et de masse la valeur totale de Susceptance d pend de la fr quence La Susceptance compliante...

Page 186: ...s App 5 5 2 Conductance G La conductance est d finie comme la quantit d nergie dissipp e sous forme de chaleur dans le syst me auditif sous forme de frottements Les frottements sont dus aux impacts en...

Page 187: ...on s approche d une r gion fr quence contr l e par la Masse Plus l influence de la courbe de Sus ceptance des l ments de Masse augmente lorsqu on s approche de la pression de cr te moins le rapport e...

Page 188: ...stica rimanente a seconda della quantit di pressione atmosferica o di attivit muscolare L ammettenza dell energia acustica massima punto nel quale la quantit maggiore di energia acustica entra nell or...

Page 189: ...relativi allo sviluppo nei primi mesi di vita alterino notevolmente le propriet di risposta acustica dell orecchio medio dei bambini influenzando quindi anche la timpanometria tra questi figurano aum...

Page 190: ...mpanometrica LT costituisce una misura dell acutezza o dell inclinazione del tim panogramma La LT rappresenta la larghezza della curva nel punto corrispondente alla met dell altezza della curva SA 2 L...

Page 191: ...est sulla funzione della tromba in orecchie con timpano intatto ETF I vengono registrati diversi tim panogrammi effettuando varie manovre di equalizzazione della pressione dell orecchio medio tra una...

Page 192: ...mettenza risultante dal meccanismo di riflesso molto ridotto Questo cambiamento ancor pi ridotto se il timpano in tensione a causa di un differenziale della pressione statica tra il con dotto uditivo...

Page 193: ...renze nella rilevabilit a seconda della frequenza del segnale del tono puro utilizzato Il test del riflesso acustico implica l uso di alti livelli di stimolo per provocare un riflesso Questi livelli a...

Page 194: ...normalmente provoca l apertura della tromba di Eustachio se funzionante In caso di equalizzazione della pressione attraverso la tromba sar visualizzata una riduzione improvvisa della pressione che si...

Page 195: ...a Suscettanza negativa In questo caso l orecchio controllato dalla Massa Ci vale quando la frequenza del tono sonda superiore rispetto alla frequenza di risonanza dell orecchio Suscettanza zero Se qua...

Page 196: ...quando la misurazione viene effettuata utilizzando un tono sonda con un unica alta frequenza i com ponenti B G forniscono una panoramica pi chiara dello stato dell orecchio medio specialmente quando...

Page 197: ...llo stesso modo possibile sottrarre la Conduttanza del condotto uditivo da ciascun punto della curva della Con duttanza Dopo aver eseguito queste due compensazioni dei componenti separatamente possibi...

Page 198: ...a descripci n 170 Admittance contr le 184 monitoring 145 Admittance recording testing 103 admittance statique description 180 Admittanz berwachung 164 Ammettenza monitoraggio 193 Ammettenza statica SA...

Page 199: ...Eartips disposal 124 EBV siehe ECV 160 v ase ECV 170 vedere ECV 190 voir ECV 180 ECV 152 ECV Beschreibung 160 descripci n 170 description 180 descrizione 190 EFT I Manovra di Valsava 191 ETF I Beschre...

Page 200: ...Eustaquio v ase ETF I o ETF P 171 173 Funktion Eustachische R hre siehe ETH I oder ETF P 161 164 Funzione tromba di Eustacchio vedere ETF I o ETF P 191 194 G Geh rgangvolumen quivalent 160 H Halbwert...

Page 201: ...ription 180 Larghezza timpanometrica LT descrizione 190 LT descrizione 190 M Maintenance cleaning agents 119 cleaning device 118 Maniobra de Toynbee 172 Maniobra de Vasalva 171 Man uvre de Toynbee 182...

Page 202: ...bambini piccoli 193 S SA Beschreibung 160 descripci n 170 description 141 180 descrizione 190 Screening de reflejo ac stico descripci n 172 Screening riflesso acustico descrizione 193 Seuil du r flexe...

Page 203: ...c Reflex 58 92 Admittance recording 103 ETF P 106 Manual Tymp 101 Reflex decay 65 Reflex Decay 98 Reflex threshold 61 Tympanometry 88 Tiempo de vida media descripci n 173 Timpanometria caratteristiche...

Page 204: ...om trie description 179 fonctionnalit s 180 syst me de classification 181 test des enfants 179 type description 181 Tympanometrieweite Beschreibung 160 Tympanometry 88 classification system 142 descri...

Page 205: ...o uditivo equivalente 190 volume quivalent du conduit auditif 180 Volumen equivalente del conducto auditivo externo 170 154 ETF I ETF P 153 155 154 153 154 154 154 150 154 152 152 151 151 Otometrics M...

Page 206: ...152 151 151 152 150 152 206 Otometrics MADSEN Zodiac Index...

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