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Madsen zodiac, User Manual

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MADSEN Zodiac isintended for use in the electromagnetic environment specified below. The user of MADSEN Zodiac should ensure that it isused in such an

environment.

Emissionstest

IEC 60601

test level

Compliancelevel

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

3Vrms

150 kHzto 80 MHz

3Vrms

150 kHzto 80 MHz

Portableand mobile RF communications equipment

should beused no closer to any part of MADSEN Zodiac,

including cables, than the recommended separation dis-

tance calculated from the equation applicable to the fre-

quency of the transmitter.

Recommended separation distance:

d = 1.2

d = 1.2

for 80MHz to 800 MHz

d = 2.3

for 80MHz to 2.5 GHz,

where

P

is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation dis-

tance in metres (m).

Field strengthsfrom fixed RF transmitters, asdeterm-

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:

Radiated RF

IEC 61000-4-3

3V/m

80MHz to 2.5 GHz

3V/m

80MHz to 2.5 GHz

Note 1

:At 80 MHzand 800 MHz the separation distancefor the higher frequency range applies.

Note 2

:These guidelinesmay not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and

people.

a. Field strengthsfrom fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,amateur radio, AM and FMradio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should beconsidered. If the measured field strength in the location in which MADSEN Zodiac isused exceeds the applicable RF

compliance level above, the MADSEN Zodiac should be observed to verify normal operation. If abnormal performance is observed, additional measures

might benecessary, such as reorienting or relocating MADSEN Zodiac.

b. Over the frequency range 150 kHzto 80MHz, field strengths should beless than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and MADSEN Zodiac

The MADSEN Zodiac is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the

MADSEN Zodiac can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equip-

ment (transmitters) and the MADSEN Zodiacas recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

W

Separation distance according to frequency of transmitter

m

150 kHzto 80 MHz

d = 1.2

80MHz to 800 MHz

d = 1.2

800 MHzto 2.5 GHz

d = 2.3

49

User Guide

Otometrics - MADSEN Zodiac

Summary of Contents for zodiac

Page 1: ...MADSEN Zodiac Diagnostic Clinical Stand alone User Guide Doc No 7 50 1700 EN 03 Part No 7 50 17000 EN ...

Page 2: ...ufacturer 2016 2016 GN Otometrics A S All rights reserved Otometrics the Otometrics Icon AURICAL MADSEN ICSandHORTMANN are registered trademarks of GN Otometrics A Sin the U S A and or other countries Versionrelease date 2016 09 30 143310 Technicalsupport Please contact yoursupplier Otometrics MADSEN Zodiac 2 ...

Page 3: ...8 8 Special tests 19 9 Testingwith Zodiac Diagnostic or Clinical Stand alone 20 10 Managingtest results in MADSEN Zodiac 33 11 Printingand data transfer from Zodiac 34 12 Troubleshooting 34 13 Service cleaning and calibration 35 14 Technical specifications 40 15 Standards and warnings 50 16 Other references 53 17 Manufacturer 53 3 User Guide Otometrics MADSEN Zodiac ...

Page 4: ...ing probes The hand held Quick Check probe The two diagnostic probe types Classic and Comfort A contralateral insert phone or TDH 39 Supportedtests Depending on the configuration Zodiac supports the following tests and functionalities Tympanometry Reflex Screening Reflex Threshold Reflex Decay ETF I Eustachian Tube Function Intact ETF P Eustachian Tube Function Perforated Admittance Recording mult...

Page 5: ...ildren and adults Use clinical diagnostic and screening tympanometry and reflex measurements MADSEN Zodiac uses technologies which are highly effective for clinical and screening purposes Tympanometry and acous tic reflex measurements measure the mechanical response of the middle ear and form a basis for evaluating whether the related physiological structures are functioning correctly or not Contr...

Page 6: ...npacking 1 Unpack the device carefully When you unpack the device and accessories it is a good idea to keep the packing material in which they were delivered If you need to send the device in for service the original packing material will protect against damage dur ing transport etc 2 Visually inspect the equipment for possible damage Ifdamage has occurred do not put the device into operation Cont...

Page 7: ... make an admittance calibration See the Zodiac ReferenceManual Probe home You can mount the probe home on the wall using the optional probe home wall mount kit Powering See Powering the device 7 4 1 Powering the device Zodiac is powered through an external power supply connected directly to the mains outlet Caution Use only the power supply specified in Technical specifications 40 Connectingthe ex...

Page 8: ...s light up 2 To switch off Zodiac press the On Off button Ifneeded switch off the mains supply and disconnect the power supply from the mains outlet 4 2 Connecting to the PC To connect Zodiac to the PC you must install OTOsuite on the PC For instructions on installing OTOsuite see the OTOsuite Installation Manual which you can find on the OTOsuite install ation medium disk or memory stick Caution ...

Page 9: ... spool of the used paper roll 3 Loosen the paper end edge from the new paper roll 4 Make sure that the paper compartment is clean 5 Place the paper roll in the compartment with the loose end opening towards the back of the compartment and upwards from the bottom of the com partment When you pull the paper upwards before closing the cover you will see the Otometrics watermark 6 Tear off the part of...

Page 10: ...p can be used for both ears If you suspect infection in one ear use a clean eartip and probe tip before you continue testing on the other ear Hygienic precautions Be sure to follow any established infection control procedures for the setting in which you are working Always use clean eartips To prevent cross infection use new eartips when you test the next client 5 1 The Quick Check probe Ifapplica...

Page 11: ...rip Overhand grip Startingthe test The test starts automatically when you press the screening eartip gently into the ear canal and seal is obtained Stoppingthe test You can stop the test by removing the probe from the test ear 5 2 The diagnostic probes Depending on the configuration of the device Zodiac Diagnostic and Zodiac Clinical are delivered with a diagnostic probe already connected The diag...

Page 12: ...gnostic probe is connected to the probe shoulder strap Warning Always fit an eartip on the probe before inserting it into the ear of the patient The Classic probe The Comfort probe The shoulder strap The shoulder strap is aflexible strap designed to fit across the shoulder ofthe patient It ensures that the diagnostic probe stays in place during testing so that measurements will not be influenced b...

Page 13: ...lected test ear and probe status B Ear button Press this button to switch test ears C Start stopbutton Press this button to start or stop a test The diagnostic probe A The light indicator shows the color ofthe selected test ear probe status and leakage status B Probe body C Probe ring D Probe tip 5 2 2 Using two probes with the device Ifthe probe you wish to use is not activated press any one of t...

Page 14: ... be used for both ears If you suspect infection in one ear use a clean eartip and probe tip before you continue testing on the other ear Warning Do not use the contralateral insert phone in an ear with discharge Use a supra aural phone instead Warning To prevent cross infection use new eartips when you test the next client 1 Fit a suitably sized foam eartip on the contralateral insert phone 2 Befo...

Page 15: ...nt panel A Startingand ending a session B Measurement selections C Runningtests D On screen selections Depending on the configuration of the stand alone version ofZodiac the front panel has arange offunction buttons a dial and three soft buttons Startingand ending a session New Session Press this button to create a new session Report The function ofthis button depends on the configuration of the s...

Page 16: ...ment You can choose between the following frequencies 0 5 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 facilitate reflex recordings from ears that have steeply sloped tym panograms Keep the button depressed and use the dial to select the desired...

Page 17: ...nningtests 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 atympanometric measurement to start reflex tests and to present stimuli for manual reflex testing During atest press this button to stop the test Auto start Press this button to activate Auto start on seal before you place...

Page 18: ...s enabled when you activate the Menu function Press this button until you highlight the desired area on the screen Dial In addition to the various measurement functions you can use the dial to scroll between menu items on the screen 7 The Zodiac menu Ifyou use a stand alone version of Zodiac you can use the function specific buttons to activate the most commonly used functionsfor testing changing ...

Page 19: ...croll to Apply Tem porarily and press the OK soft button This will exit the menu system Saving test settings inthe protocol Before you can save test settings in the protocol you must unlock the protocol Select 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 Ifyou wish to save the changed pr...

Page 20: ... and decay measurements These measurements can be performed manually auto matically or in a sequence of tests with the option ofusing mul tiple probe tones An additional range offeatures is described in detail in the MADSEN Zodiac Reference Manual Zodiac has two probe connections which make it possible to choose between using aQuick Check probe for fast tym panometry and adiagnostic probe for more...

Page 21: ...n the probe The Quick Check probe We recommend that you use an oversized eartip with the Quick Check probe The diagnostic probe Fit the eartip on the probe Fittingthe 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 Removingthe eartip To remove the eartip grasp the stem ofthe eartip and pull the eartip straight off th...

Page 22: ...n the shoulder of the patient 4 To stabilize the probe and to avoid blocking the probe against the ear canal ofthe patient grasp the pinna and gently pull the pinna back and slightly away from the patient s head For adults pull the pinna upwards and back For infants and children pull the pinna down wards and back 5 Insert the probe in the patient s ear canal while twistingthe probe gently When the...

Page 23: ... testing this will be shown on the MADSEN Zodiac and OTOsuite screens Ifyou are using the Quick Check probe the leakage indication will remain until you remove the probe from the ear and try again Probe blocked Ifthe probe is blocked during testing this will be shown on the MADSEN Zodiac and OTOsuite screens Ifyou are using the Quick Check probe the blocked probe indication will remain until you r...

Page 24: ...to stop the test The test is interrupted and the pump pressure is relieved immediately Alreadymeasured results are kept when a measurement is stopped Alternatively you can pause the test by pressing the Pause softbutton and resume the test without running the entire test again Performing supplementary measurements You can always supplement the results if needed For example if you need asupplementa...

Page 25: ...e device or the Start Stop button on the probe control pad on the shoulder strap With the diagnostic probe you can also use automatic start Press the Start Stop button before placing the probe in the patient s ear Stopping the test 1 Ifthe patient is troubled by the test press the Start Stopbutton on the device or the Start Stopbutton on the probe control pad on the shoulder strap 2 The test is in...

Page 26: ...cale automatically to fit the curves Tympanometric curves Pressure and admittance scales Ear canal volume bar The ear canal volume is shown to the right ofthe graph Norm area C Reflex Screening results The detected reflex is shown in the results area Stimulustype level Progressindicator during measurements Deflection curves are shown when a reflex has been detected Ifa reflex is not detected the h...

Page 27: ... Note This test is available only ifMADSEN Zodiac supportsdiagnostic testing Procedure All three result rows in the Tympanometry results table will be used for this test 1 Select the Tympanometry test screen 2 Record atympanogram 3 Instruct the patient to perform a pressure equalization maneuver 4 Record asecond tympanogram 5 Compare the tympanograms from step 1 and 3 in the multilayered tympanogr...

Page 28: ...g loud stimuli Whenever an intensity level exceeds the warning level 100 dB HL a warning message will be shown and you will be prompted to decide whether to continue or to move on to the next stimulus type 9 8 1 Reflex Threshold testing You can record areflex threshold either as aseparate measurement or as part of adiagnostic sequence In Sequence test ing the test automatically suggests the thresh...

Page 29: ...round the deflection graph to indicate that the test has started 8 Ifneeded 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 9 Ifneeded repeat these steps until you have collected the desired meas urements Warning If the patient is troubled by the test stop the test The test is interrupted immediatel...

Page 30: ...ion curves the associated level and numerical deflection values Reflex deflection curves The detected threshold is framed in the color of the test ear The dashed horizontal line in each reflex graph indicates the predefined reflex criterion It is offset from the base line marker on the vertical axis Reflex Thresholdresults table Use the buttons in the Reflex section on the front panel to navigate ...

Page 31: ...d time Note It is recommended that you perform a tympanometric test before making any acoustic reflex measurement and determine the acoustic reflex threshold before making a reflex decay measurement Starting the test 1 Press 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 ...

Page 32: ...s relieved imme diately Alreadymeasured results are kept when a measurement is stopped 9 8 2 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 The on line values show the current settings and status Probe tone in Hz Stimulusside Stimulusfrequency Stimuluslevel Current pressure and admittance scales Otometrics MADSEN Z...

Page 33: ... using the dial Hide Marker Show Marker If for example the result 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 selected value 10 Managing test results in MADSEN Zodiac The following applies to managing test results in MADSEN Zodiac Ifyou wish to perform...

Page 34: ...ing with OTOsuite you can fetch the patient s test resultsfrom Zodiac 12 Troubleshooting 12 1 Probe problems possible causes Testingmay be complicated by anumber of factors which can result in leakage or probe problems The eartip does not fit well The eartip is not inserted properly in the ear canal The probe tip opening is blocked by the wall ofthe ear canal The eartip may be old or hardened The ...

Page 35: ...gnostic probe and if applicable the Quick Check probe is connected permanently to the device Caution A Zodiac probe should only be disconnected or replaced by an authorized service technician 13 2 Cleaning the device Caution Make sure that you comply with local infection control regulations Caution Use only the cleaning agents prescribed for cleaning the device See Recommended cleaning agents 36 F...

Page 36: ...Ammonium compounds e g dimethyl benzyl ammonium chloride in concentrations no stronger than 0 1 Aldehyde solutions e g glutaraldehyde Oxidizing agents e g Hydrogen peroxide in concentrations no stronger than 3 Ortho phthalaldehyde in concentrations no stronger than 0 6 Caution If plastic parts are soaked in a cleaning agent they will deteriorate 13 2 2 Cleaning the shoulder strap Use a soft slight...

Page 37: ...h a disinfectant wipe such as Audio wipes between patients or replace it with a spare one Wipe the cable with a disinfectant wipe such as Audio wipes Wipe the probe home with a disinfectant wipe such as Audio wipes Alternatively use a damp non flocculent cloth with a small amount of the recommended cleaning agent Cleaningor replacing the probe tip The system is delivered with replacement probe tip...

Page 38: ... clean the sound channels Caution Never clean the sound channels in the probe body as this may cause damage 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 13 2 4 The test cavities Ifa test cavity becomes contaminated do not use it Dispose of it and replace it with a new one 13 2 5 Cleaning the printer Ch...

Page 39: ... and follows the probe The probes can be used right away This also applies to the contralateral insert phone Probe check The probe should be checked daily See Probe check 39 Additional probe admittance checks can be performed See the MADSEN Zodiac Reference Manual Note Ifthe test environment changes for instanceif there is an increase in humidity or if you are going to test at a different altitude...

Page 40: ...starts automatically If it does not press the Start button to start the check The probe is checked for occlusion and leakage If the probe check result shows avalue of 1 9 2 1 mmho cc ml at 226 Hz the probe is OK Ifnot we recom mend that you make an admittance calibration Additional probe admittance checks can be performed See the MADSEN Zodiac Reference Manual Ifthere is a probe error In case of a...

Page 41: ... Step size dB Diagnostic 5 10 dB Clinical 1 2 5 10 dB Contralateral Stimulation Pure tones 500 Hz 1000 Hz 2000 Hz 4000 Hz Frequency accuracy 0 5 Range BBN LPN HPN at 50 to 110 dB SPL 3 dB measured in the respective couplers Contralateral insert phone Contralateral TDH 39 phone Range 500 Hz at 50 to 115 dB HL 3 dB 1000 Hzat 50 to 120 dB HL 3 dB 2000 Hzat 50 to 120 dB HL 3 dB 4000 Hzat 50 to 120 dB ...

Page 42: ...n calibration coupler Screening range BBN at 50 to 90 dB SPL 3 dB measured in calibration coupler Step size dB 1 2 5 10 dB Decay range 50 to 100 dB HL artifacts may start to occur at levels above 95 dB HL in 0 5 cc Temporalcharacteristics Reflex Decay Contralateral Reflex Threshold and Screen ing Ipsilateral Reflex Threshold and Screening Contralateral stimulation Probe tone 226 Hz Initial termina...

Page 43: ...erance 5 dB Lowpassnoise Contralateral TDH 39 headphone Band limit 1600 Hz nominal 3 dB point Slope The slope is between 12 and 18 dB octave above 1600 Hz with an additional 6 dB tolerance Above 8500 Hz the spectrum level remains below 34 dB re 1600 Hzlevel Level Noise level is indicated in dB HL Tolerance 5 dB Contralateral insert earphone and ipsilateral probe Bandwidth 1600 Hz nominal 3 dB poin...

Page 44: ... 6 5 6 0 8 0 12 0 13 5 LBN 3 7 5 9 5 8 5 10 5 11 5 HBN 3 4 0 5 0 7 5 12 5 14 5 Notes 1 From ANSI ASA S3 6 2010 Table 5 2 From ANSI ASA S3 6 2010 Table 7 3 Based on Otometrics internal study Air pressure system Range Normal 200 to 400 daPa s Extended 400 to 600 daPa s Pressure sweep rate 50 100 200 400 600 daPa s 20 in 20 to 80 ofthe total pressure range Pressure accuracy 10 or 10 daPa whichever is...

Page 45: ...g Air pressure 600 hPa to 1060 hPa Warm up time 10 min Ifstored in conditions not within specified operating environment conditions the device must warm up for 24 hour before being put into oper ation Altitude correction The admittance ofa cavity depends on the atmospheric pressure This means that when the atmospheric pressure changes the relation between mmho and ml changes The following table ca...

Page 46: ...quipment should be calibrated regularly according to EN 60645 5 and ANSI S3 39 Essentialperformance MADSEN Zodiac has no essential performance and accordingly the applicable requirements are as stated in the following 1 Impedance admittance as defined by EN 61027 Type 1 ANSI S3 39 Type 1 2 Basic safety as defined by IEC 60601 1 All information required by IEC 60601 1 2 2007 5 2 2 1 5 2 2 10 is ava...

Page 47: ...stallation disk Power cord MADSEN Zodiac User Guide MADSEN Zodiac Reference Manual USB connection cable Power supply unit Paper roll for built in printer Probe tips Wall mount kit for PC based device Probe cleaning kit 14 2 Notes on EMC Electromagnetic Compatibility MADSEN Zodiac is part ofa medical electrical system and is thus subject to special safety precautions For this reason the installatio...

Page 48: ...lative humid ity should be atleast 30 Electricalfast transient burst IEC 61000 4 4 2 kVfor power supply lines 1 kVfor input output lines 2 kVfor power supply lines 1 kVfor input output lines Mainspower quality should be that of a typical com mercialor hospital environment SurgeIEC 61000 4 5 1 kVline s to line s 2 kVline s to earth 1 kVline s to line s 2 kVline s to earth Mainspower quality should ...

Page 49: ...ection from structures objects and people a Field strengthsfrom fixed transmitters such as basestations for radio cellular cordless telephones and land mobile radios amateur radio AM and FMradio broadcastand TVbroadcast cannot be predicted theoretically with accuracy To assessthe electromagneticenvironment dueto fixed RF transmitters an electromagneticsite survey should beconsidered If the measure...

Page 50: ...ymbols MADSEN Zodiac Electronic equipment covered by the Directive 2002 96 EC on waste electrical and electronic equipment WEEE All electrical and electronic products batteries and accumulators must be taken to separate collection at the end of their working life This requirement applies in the European Union Do not dispose of these productsas unsorted municipal waste You can return your device an...

Page 51: ...owed to ensure the safe performance of the devices and software covered by this manual Local government rules and regulations ifapplicable should also be followed at all times 1 This class of equipment is allowed in domestic establishments when used under the jurisdiction ofa health care pro fessional 2 MADSEN Zodiac is intended for diagnostic and clinical use by audiologists and other trained hea...

Page 52: ... floor Note that calibration has been performed only on the transducers supplied Ifyou wish to use any other transducer for testingwith the device please contact your local distributor first 17 Disposable accessories such as eartips should not be reused and must be replaced between patients to prevent cross infection 18 Unwanted noise may occur if the instrument is exposed to a strong radio field ...

Page 53: ...to which the receiver is connected Consult the dealer or an experienced radio TVtechnician for help 16 Other references For more information see the online Help in OTOsuite which contains detailed reference information about MADSEN Zodiac and the OTOsuite modules For instructions on installing OTOsuite see the OTOsuite Installation Manual which you can find on the OTOsuite install ation medium dis...

Page 54: ...manufacturer reserves the right to disclaim all responsibility for the operating safety reliability and performance of equipment serviced or repaired by other parties Otometrics MADSEN Zodiac User Guide 54 ...

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