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14

Standards and safety

This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.

See

and

14.1

Symbols used

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
products as unsorted municipal waste.

You can return your device and accessories to Natus Medical Denmark ApS, or to any Natus
Medical Denmark ApS supplier. You can also contact your local authorities for advice on disposal.

Consult user manual for warnings and cautions.

Follow instructions for use.

Consult instructions for use.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1
(2014) and CAN/CSA-C22.2 No. 60601-1-6 (2011).

Complies with Type B requirements of IEC60601-1.

Suitable for alternating current only.

Power ON.

Power OFF.

The device is susceptible to electrostatic discharge.

Do not reuse.

Otometrics - MADSEN Xeta

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Summary of Contents for Madsen Xeta

Page 1: ...MADSEN Xeta Reference Manual Doc No 7 50 0870 EN 17 Part No 7 50 08700 EN ...

Page 2: ... Otometrics the Otometrics Icon AURICAL MADSEN Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2019 06 09 214081 Technical support Please contact your supplier Otometrics MADSEN Xeta 2 ...

Page 3: ...S 17 3 2 3 MASKING 18 3 2 4 TEST 18 3 2 5 Signal indicators 19 3 2 6 Extended Range 19 3 2 7 Clear 20 3 2 8 Patient handling buttons 20 3 2 9 Setup 20 3 2 10 Change Ear L R 21 3 2 11 Store toggle threshold status 22 3 2 12 Response indicator 22 3 2 13 Stimulus masking intensity knobs 22 3 2 14 Present signal buttons 23 3 2 15 Frequency 23 3 2 16 Talk Over 23 3 2 17 Mic microphone 24 3 2 18 Start P...

Page 4: ...n testing 48 5 2 6 Preparing for testing with masking 49 5 3 Listening check 49 5 4 Preparing the client 50 5 4 1 Hygienic precautions 50 5 4 2 Inspecting the client s ear s 50 5 5 Preparing the Audiometry Module for testing 50 5 6 Proper transducer placement 50 5 7 The client patient list 52 5 7 1 Create patients for the patient list 52 5 7 2 Transfer the patient list to the audiometer 52 5 8 Fet...

Page 5: ...e 80 9 2 Updating device firmware 80 10 Maintenance and calibration 81 10 1 Service and repair 81 10 1 1 Fuses 81 10 2 Cleaning 81 10 3 Calibration 82 11 Unpacking and installing 83 11 1 Unpacking 83 11 2 Storing 83 11 3 Installation 83 11 3 1 Powering 84 11 3 2 Connecting to a pc 84 11 3 3 Air conduction 84 11 3 4 Bone conduction 85 12 Maximum non destructive voltage 87 12 1 Input and output sock...

Page 6: ...Index 103 6 Otometrics MADSEN Xeta ...

Page 7: ...ram s while testing with a connected Otometrics audiometer As the module is part of OTOsuite audiograms can be used directly in other OTOsuite modules such as AURICAL Coun seling and Simulations for an optimized workflow independent of NOAH The OTOsuite Audiometry Module lets you work with NOAH or save and view results via XML files The current version supports basic tone audiometry and speech tes...

Page 8: ...arnings which must be followed to ensure the safe performance of MADSEN Xeta Warning Local government rules and regulations if applicable should be followed at all times Standards and safety 91 gives you an overview of device labelling and standards Warning notes 92 contains relevant warning notes Training It is recommended that you read this manual and the OTOsuiteUser Guide and make yourself fam...

Page 9: ...here is a risk of death or serious injury to the user or patient Caution Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device Note Indicates that you should take special notice 1 4 1 Navigation Menus icons and functions to select are shown in bold type as for instance in Click the Set Options icon on the toolbar or select Tools Options Otometrics ...

Page 10: ...theses See Patient data 11 for patient handling 8 You are ready to start testing Manual air conduction testing To perform manual air conduction testing see Air Conduction threshold test manual 67 Bone conduction testing To perform bone conduction testing see Bone Conduction threshold test manual 70 Special tests To select other tests such as SISI see SISI Short Increment Sensitivity Index 74 Steng...

Page 11: ...bs J Present interrupt signal buttons K Frequency selection knob L Start Pause 2 1 Patient data Patients are either scheduled and listed in OTOsuite Scheduled patients or stored in numbered patient records in MADSEN Xeta Tested patients See also Patient record lists 46 A Tested patient records B Scheduled patients Otometrics MADSEN Xeta 11 2 Getting started ...

Page 12: ...struct the patient in using the Patient Response Switch See The patient responder 47 2 3 Automatic Air Conduction testing 2 3 1 Automatic Threshold testing The Automatic Threshold test presents tones to the patient at rising and falling levels in relation to the actual patient response The test logic adheres to the modified ascending Hughson Westlake method See Air Conduction threshold test manual...

Page 13: ...king may be recommended 5 To retest any frequencies see Air Conduction threshold test manual 67 and if required Testing with masking 72 6 If required select the next patient record press Previous Next or press New Patient 2 3 2 Automatic Screening Screening audiometry is a quick and simple way to identify patients in need of thorough audiological evaluation The test involves presenting tones at a ...

Page 14: ...on testing 12 Note You can use Talk Over at any time during the test This will pause the test The test is resumed when you release the Talk Over button 3 Xeta beeps twice and the display shows that the test is completed The results are stored automatically 4 To retest any frequencies see Automatic Air Conduction testing 12 and Air Conduction threshold test manual 67 5 If required select the next p...

Page 15: ...isplay A Test signal indicator B Audiogram symbols C Stored threshold D Function key markers E Ear indicator During start up the display briefly shows information regarding the device type and version followed by the test screen last used The abbreviations used on the display are explained in Abbreviations 89 Top line During testing the top line in the display shows the intensity numerically in dB...

Page 16: ...oid masked Other symbols Stored a Automatically tested preceded by the relevant response symbol fs Failed screening level Auto Screening only s Screening level preceded by the relevant response symbol 3 2 Front panel controls You can access all basic functions directly by using the buttons and knobs on the front panel The button light indicators Each button has its own function Some buttons have a...

Page 17: ...20 I Setup 20 J Change Ear L R 21 K Store toggle threshold status 22 L Response indicator 22 M Stimulus masking intensity knobs 22 N Present signal buttons 23 O Frequency 23 P Talk Over 23 Q Mic microphone 24 R Start Pause 24 Beep If you try to use a button which is not enabled you will hear two short beeps MADSEN Xeta also beeps when an automatic test is completed and when settings are stored 3 2...

Page 18: ... is presented with a Pulse Pause ratio of 50 Timed The stimulus signal is presented with a preset duration Does not apply in Reverse mode 3 2 3 MASKING By default you always adjust the stimulus signal level on the Left Level knob regardless of whether you are testing the right or left ear To adjust the masking intensity use the Right Level knob To change the default setting see Level knob 62 Contr...

Page 19: ...resented in the corresponding ear Discreet mode In the Auto Threshold and Auto Screening tests you can change the setting of the signal indicators to Dis creet mode which means that they do not light up when the test signal is presented If MADSEN Xeta is in view of the patient this will prevent the patient from knowing when a signal is presented This mode also prevents the patient from simulating ...

Page 20: ...record lists 46 Preview Press to view patient records and test data Displays the patient name and ID If the name is too long the display will show the first part briefly then switch to the second part If required press Change Ear to view data for the other ear See also Viewing results 12 for examples Scroll Patient List When MADSEN Xeta is switched on a new patient record is automatically availabl...

Page 21: ...used settings MADSEN Xeta is optimized for testing patient after patient in the same consistent manner To support this MADSEN Xeta remembers the settings you used for testing the previous patient i e the settings selected when the first threshold was stored If Setting 1 or Setting 2 was used that setting will automatically be reloaded and used for the next patient Set tings are reloaded whenever y...

Page 22: ...lue is shown in the display by means of an symbol beside the frequency indication and the applicable audiogram symbol beside the level indication depending on the selection of ear masking and transducer type 3 2 12 Response indicator Lights up when the patient presses the patient responder You will hear a beep at the same time See The patient responder 47 3 2 13 Stimulus masking intensity knobs Le...

Page 23: ...he right Present Signal button usually functions in total parallel with the left Present Signal button Controlling the masking signal Controls the masking signal See Mask present 60 3 2 15 Frequency The Frequency knob changes the frequency scrolls between values and functions shown in the display Changing the frequency Turn clockwise to increase the frequency and counter clockwise to decrease it T...

Page 24: ...ant test button to stop the test SISI If you have paused the SISI test press to stop test completely during the pause 3 3 Socket connections rear panel A AC left B BC C AC right D Masking insert E Patient response F RS232 interface G On off switch H Mains power socket AC LEFT and AC RIGHT Connection for the AC transducer to the enclosed headphone Blue 1 4 jack plug for AC Left and red 1 4 jack plu...

Page 25: ...lementary provisions on the reliability of electro med ical systems It is a general rule for all electrical equipment used in the proximity of the patient that The connected equipment must comply with Medical Electrical Systems in IEC 60601 1 3 1 edition 2012 Any PC connected to the Xeta must comply with the requirements of IEC 60950 Safety of information technology equip ment including electrical...

Page 26: ...3 Overview of MADSEN Xeta 26 Otometrics MADSEN Xeta ...

Page 27: ...tures below are device dependent With the Audiometry Module you can perform testing while you follow stimulus settings and test progress on your PC display view and print test results view historic audiometry results from NOAH view online audiometry results during testing use the Masking Assistant to prompt when masking is recommended view the masking level indicator in audiogram view audiogram ov...

Page 28: ...New Audiogram Select new audiogram You will be prompted to save or cancel current data 4 2 2 Edit menu Menu item Shortcut Description Audiometric prop erties Ctrl U Click to enter Tester name Test Date and air conduction transducer for a manu ally entered audiogram Note The air conduction transducer is stored when you have selected it in the transducer section of the Control Panel or with device c...

Page 29: ... or both a left and a right audiogram on your screen Combined View Click to view both ears in a single audiogram Split View Click to view separate audiograms for each ear Left Right Click to display the left ear audiogram on the left side of the window and the right ear audiogram on the right side of the window when Dual Graph View is enabled in Options Audiometry Tone Misc Right Left Click to dis...

Page 30: ...es and Symbols Click to select the Curves and Symbols dialog box This dialog box and its related function are specific to configuring the curves and symbols to be displayed on the audiogram or speech graph during testing See Curves and symbols selection 39 Manage Client List See description in The client patient list 52 Fetch Test Results See description in Fetch test results from audiometer 52 Op...

Page 31: ...pressing the right response button Blue Indicates that the patient is pressing the left response button Red and blue Indicates that the patient is pressing both response buttons 4 4 The Masking Assistant If the Masking Assistant is enabled it will at all times check for frequencies that may require testing with masking This also applies to old audiograms imported from NOAH or XML as long as a supp...

Page 32: ...hen the following conditions are met AC AC ACc Min IA or AC BCc Min IA BC BC AC x dB Only stored thresholds measured without masking are checked Levels which did not evoke a response are excluded from the check This means that as soon as a masked threshold has been stored the flashing stops for that frequency denotes configurable Air Bone gap criterion Tools Configuration Wizard Audiometry Configu...

Page 33: ... Agnew BJA 1999 500 64 Munro Agnew BJA 1999 750 60 N A traditional value 1000 58 Munro Agnew BJA 1999 1500 60 N A traditional value 2000 56 Munro Agnew BJA 1999 3000 58 Munro Agnew BJA 1999 4000 72 Munro Agnew BJA 1999 6000 54 Munro Agnew BJA 1999 8000 62 Munro Agnew BJA 1999 4 5 The Audiometry Module Control Panel Click the Control Panel icon in the toolbar to activate the Control Panel 1Katz J L...

Page 34: ...c test Fig 1 The MADSEN Xeta Control Panel 4 5 1 The Control Panel When you activate the OTOsuite Audiometry Control Panel MADSEN Xeta automatically connects to the audiometer Note You cannot operate MADSEN Xeta from the Control Panel The Control Panel is divided into a number of sections where you can view various settings and a section for controlling communication with the audiometer 34 Otometr...

Page 35: ...the audiometer does not correspond with the patient shown in OTOsuite or NOAH status bar a warning triangle will be shown on the screen Make sure that you select the correct patient either in the audiometer or in OTOsuite 4 6 The stimulus bar A Intensity B Stimulus indicator C Transducer indicator D Stimulus being presented E Frequency F Stimulus bar color G Routing indicator H Masking on Otometri...

Page 36: ...stimulus masking type the transducer and the routing for each channel 4 6 1 The Tone stimulus bar A Symbol B Frequency During online testing the stimulus bar shows Symbol Indicates the symbol that will be displayed on the audiogram s when a data point is stored The symbol shown reflects the current audiometer measurement settings See also Curves and symbols selection 39 Frequency Indicated by the ...

Page 37: ...gend box 41 With a description of result boxes for special tests utilities such as a timer and an overlays selector and instructions for how to view hide the feature boxes 4 7 2 The audiogram Audiogram elements Cross hatch Indicates your current stimulus level and frequency The color indicates the rout ing Blue left Red right Black binaural Mouse cursor Indicates where you place the mouse The colo...

Page 38: ...tor C Mouse cursor ear color Dual graph view When you use the dual graph viewing option the graph that corresponds with the stimulus ear will have a gray outline to denote the active audiogram You can switch the position of the right and left graphs to cor respond to your viewing preference 1 Select Tools Options Tone Misc Dual Graph View or in the menu bar under View A Stimulus marker ear color B...

Page 39: ...te new symbols 4 7 3 1 Selecting a symbol or curve You can select a symbol and or a curve style for a specific measurement 1 Select Tools Curves and Symbols 2 Click on the selections that apply to your measurement under Test Transducer and Aided Condition The current symbols and line style are shown 3 Double click on the symbol you wish to change The Symbols selection dialog box is shown 4 Double ...

Page 40: ...rrows for No Response or Response at Limit and designators for Aided Left or Aided Right 3 Before you store the new graphic make sure that the outer and inner frames are invisible Select the frame and set the line color to No Line Repeat this for each frame 4 To save as an emf graphics file select all elements in the drawing including the invisible outer frame as well as the symbol itself centered...

Page 41: ...ence view This is done by checking the Difference option in the fea ture box The Difference view highlights any difference between the most recent and any older audiogram curves selec ted in the list 4 If you decide to make a new audiogram then a new Current audiogram is generated in the Compare Audiograms fea ture box list and what was previously the current audiogram consequently becomes a histo...

Page 42: ...nds at their approx imate dB level e g bird plane Severity Displays the audiometric severity levels normal mild moderate moderate to severe severe profound Speech Banana Displays the speech banana of a listener with normal hearing Speech Letters Displays speech sounds at their approximate dB level Unusable area Shades the area which is outside the patient s dynamic range of hearing 42 Otometrics M...

Page 43: ...lation to your mon itor Control Click to select the position of the stimulus channel on the screen 4 8 2 Ear shift frequency and level setting When you change test ear you can define that the frequency and level should be set to 1000 Hz at 20 dB HL To do so select Tools Options Tone Measurement Ear Shift Frequency and Level Check Ear Shift Frequency and Level Otometrics MADSEN Xeta 43 4 Navigating...

Page 44: ...4 Navigating in the OTOsuite Audiometry Module 44 Otometrics MADSEN Xeta ...

Page 45: ...ent patient can anticipate when the stimulus will be presented For pediatric testing consider using a highchair which is a familiar environment for most children and will place them closer to eye level with the visual reinforcement toys Make sure if performing visual reinforcement audiometry that the reinforcing toys can be seen by the child A child cannot look over and up at a toy until approxima...

Page 46: ...only patient name and ID When you have saved test data for that particular patient the patient record is moved to the Tested patients list The record will now show a list number in the lower right corner of the display Tested patients scheduled and unscheduled Consists of records from scheduled and tested patients and records created by pressing New Patient and storing test data These records hold...

Page 47: ...if only weak signals are heard Note During automatic testing if the patient presses the switch repeatedly during a stimulus presentation the response is ignored Note During automatic testing if the patient does not release the switch a beep is issued in the headphones If this situation is repeated the test is paused Reinstruct the patient Before testing check that the Response indicator lights up ...

Page 48: ...to choose between Forehead and Mastoid depending on the preferred placement of the bone conductor Testing with masking If you intend to use masking either use the mono insert phone recommended or fit the headphones so that the red right phone is applied to the poorer ear for masking and the other phone is applied to the patient s temple region leav ing the test ear uncovered Important The masking ...

Page 49: ...ee Testing with masking 72 When to use a mono insert phone Masking via insert phone is recommended The mono insert phone gives less inter aural cross talk than the TDH39 head phones The test procedure is similar to that described in Bone conduction with masking suggested procedure 73 Instructing the patient In addition to the tones in the test ear the patient will be hearing a noise in the other e...

Page 50: ...ot be straight 4 If the ear canal is blocked for instance by vernix or debris the outcome of the procedures may be affected Clean the ear canal if required 5 5 Preparing the Audiometry Module for testing MADSEN Xeta and the Audiometry module Make sure the cables of the test equipment are connected correctly Launch OTOsuite and the Audiometry module on the PC see the OTOsuite User Guide Make sure M...

Page 51: ...y at the low frequencies this reduces the need for masking 2 It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the foam eartip into the child s ears If the foam eartip is a little too large consider cutting it down to make it a little smaller Bone Oscillator Note For unmasked bone thresholds you can store binaural data Note If there i...

Page 52: ...ients to the list The Client Details dialog appears 3 Enter the client details see also Select create a client in OTOsuite in the OTOsuite User Manual and click OK Edit patient data 1 Select Tools Set up patient list 2 Click Edit to edit client details 3 If you change the value of the Identifier field a new client record is created 4 Click OK to exit the Client Details dialog 5 Click Next to trans...

Page 53: ...his type of noise exposure it may not be possible to determine the nor mal hearing threshold It is recommended that a minimum of 16 hours should pass between exposure and testing Explaining the test procedure Explain how the test will be done including which ear will be tested first Describe what the presented signals may sound like Explain what the patient will be expected to do This includes usi...

Page 54: ...5 Preparing for testing 54 Otometrics MADSEN Xeta ...

Page 55: ...nd general settings are permanent and will be used the next time you switch on MADSEN Xeta 6 1 Test specific settings When you select a specific test you can change a number of settings relating specifically to this test 1 Select the specific test for example AT and press Setup to change settings 2 Use the Left level knob to scroll between test settings 3 Use the Right level knob to scroll between...

Page 56: ...e cross check function is a quick test of the levels next to the 1000 Hz threshold If the 1000 Hz cross check fails a new full threshold test is made for this frequency AT Procedure Standard The stimulus but not the preset stimulus duration is interrupted by the patient response This is followed by a random inter stimulus interval Quick Both the stimulus and the preset stimulus duration are interr...

Page 57: ...the Right level knob to set the threshold detection criterion to 1 of 1 or 2 of 3 AS Level Use the Right level knob to change the starting hearing level Min 0 dB max 40 dB HL AS Do AT when AS fails Use the Right level knob to select deselect On To include Auto Threshold in the Auto Screening test The Auto Threshold test is activated immediately when a frequency fails The test returns to Auto Scree...

Page 58: ...ngs apply to all test functions However some settings do not apply in automatic testing Changing general settings 1 To access the Setup menu of Xeta press Setup When the Setup function is active the Setup button flashes Most other buttons are deactivated and you cannot run any tests 2 Turn the Left level knob to scroll through the parameter list As a rule the top line in the display contains a des...

Page 59: ...y NO CHANGE If this parameter is set to No change the setting will remain at the current fre quency when you press Store the frequency remains the same WRAP If you press Store at the highest possible frequency you switch to the lowest pos sible frequency At other frequencies pressing Store advances the frequency BUTTERFLY If you press Store at the highest or the lowest possible frequency you chang...

Page 60: ...ighest or the lowest possible frequency you change to 1000 Hz dB level new transducer Start level Choice of initial volume level for a new client ear or change between different tests Adjustable in the range 10 to 50 dB dB level new frequency New freq level Choice of initial intensity when changing frequency NO CHANGE Tthe frequency remains the same or adjustable in the range 10 to 50 dB nn dB FIX...

Page 61: ... recommended masking see description in The Masking Assistant 31 Default On Extended range Extended Range Selection of one of two modes see description in Extended Range 19 Auto Manual Default Auto Display Display Controls display setup Fixes one of the four left right configurations SIGNAL AS L R The signal for the left ear is shown on the left side and that for the right ear on the right side Ma...

Page 62: ...on the display Auto delete Auto delete Automatically deletes the oldest patient record to free memory space as required Default On AC transducer AC Transducer Choose between calibrated headphones Note If the wrong headphone is selected compared to the one that is phys ically con nected to Xeta the measurements will be incorrect None TDH39 Use this setting also for ME 70 transducers EAR3A E A R TON...

Page 63: ...eep Internal beep Switches the internal beeper in connection with the patient s response switch and under item change in Setup ON or OFF Fault beeps are not removed Baud rate Baudrate Selection of baud rate for RS232 interface 9600 19200 38400 57600 default value Default 57600 Light intensity in LEDs Light intensity Selection of brightness in LEDs All LEDs are lit Use Right level knob to adjust Di...

Page 64: ...te On Off 7 Prime Trans ducer AC BC For each prime transducer the masking settings are 8 AC masking On Off 9 MI masking On Off 10 Lock state On Off Default setting Default settings AC manual freqs All freqs on except 125 750 1500 AC Store Change freq BUTTERFLY BC manual freqs All freqs on except 750 1500 BC Store Change freq WRAP Start level 20 dB New freq Level No change Mask present Toggled Mask...

Page 65: ...sducer BC transducer First calibrated transducer Pulse frequency 1 50 Hz Stimulus timing 1 50 seconds Warble range 5 Warble frequency 5Hz Internal beep On Baudrate 57600 Baud Light intensity n a Disp brightness n a Otometrics MADSEN Xeta 65 6 MADSEN Xeta Test Settings ...

Page 66: ...6 MADSEN Xeta Test Settings 66 Otometrics MADSEN Xeta ...

Page 67: ...nge settings if required as described in MADSEN Xeta Test Settings 55 Selecting the test Select one of the following manual tone tests Press Air for air conduction testing Air Conduction threshold test manual 67 Press Bone for bone conduction testing Bone Conduction threshold test manual 70 If you are using masking see Testing with masking 72 Press More and the appropriate function key to select a...

Page 68: ...esented signal to an audible level Turn the Level knob to 40 dB HL This is to familiarize the patient with the test signal Other familiarization procedures may be preferred Test the better ear first If this is unknown start with the right ear Press L R to select the ear you wish to test Give the Patient Response switch to the patient and explain how it should be operated see The patient responder ...

Page 69: ...h the next frequency when you press Store See AC store Change freq 59 9 Continue to use the right and or left Level knob to increase decrease intensities until you have determined all thresholds Note If the thresholds measured at 1000 Hz in the ear differ by 10 dB or more even the other frequencies should be retested 10 Continue to press Store after each threshold is found to store that particular...

Page 70: ...g for bone conduction testing 48 Find the best position for the bone conductor Ask the patient to report when the tone seems the loudest Make sure that the bone conductor stays securely in place with no contact to the pinna Give the Patient Response switch to the patient and explain how it should be operated see The patient responder 47 Press Reverse to deactivate the Reverse function If you want ...

Page 71: ... level until the patient responds to the signal 5 Reduce the signal level by 10 dB and present signals at levels increased by 5 dB until the patient responds 6 Repeat item 5 1 to 3 times until the patient has responded 3 times at the same level This level represents the unmasked hearing threshold at 1000 Hz based on 3 5 ascending series In some situations it may be satisfactory with two responses ...

Page 72: ...r greater it is recommended that you retest bone conduction thresholds with masking applied to the contralateral ear See Testing with masking 72 14 If required select the next patient record press Previous Next or press New Patient 7 5 Testing with masking See Preparing for testing with masking 49 and The Masking Assistant 31 7 5 1 Air conduction with masking suggested procedure Prerequisites The ...

Page 73: ...determined masked threshold level If not repeat from step 2 8 If required test the remaining frequencies in the same way and switch to the other ear 7 5 2 Bone conduction with masking suggested procedure Prerequisites Prerequisites as in Bone Conduction threshold test manual 70 Prepare the patient for testing with masking See Preparing for testing with masking 49 It is recommended to use the defau...

Page 74: ...itivity Index Note This test is optional The SISI Test was developed by Jerger and co workers Jerger Shedd and Harford 1959 and was introduced as a pro cedure that was reliable and reasonably objective The test consists of superimposing brief bursts of 1 dB intensity increments on a sustained tone presented monaurally through earphones at a sensation level of 20 dB at each tested frequency The pat...

Page 75: ... increments use the Right level knob 0 25 5dB If you do so while the test is in progress the counters are reset to zero and the test starts again from the beginning Changing number of increments To change the preset number of SISI dB increments transmitted during a test 10 50 press Setup once and use the Right level knob Then press Setup again to implement the new setting While the SISI test is in...

Page 76: ...chieved in both ears The patient indicates this by pressing the patient responder 1 To select the test press More once or more until ABLB is shown 2 Press ABLB once and the test display is shown The top line shows the intensity for Right and Left channel and the test name The frequency of the test tone and the rate of alternation from ear to ear and back again the alternating frequency appear in t...

Page 77: ...s displayed and the button s that has have been wrongly set flash in the correct position three short flashes Masking Note The audiometer cannot perform masking during this test 7 8 The Stenger test Note This test is optional The Stenger test is used to reveal a unilateral non organic hearing loss in one ear 1 Before you perform a Stenger test measure the patient s tone thresholds for the left and...

Page 78: ...rwrite a stored threshold value THR with a new value unless you have changed the test setup during the test Simply press Store again 7 9 3 Erasing a stored threshold You can erase a stored audiogram point by pressing and holding Store until the point is erased 7 9 4 Viewing stored values 1 To view stored values select the appropriate patient from the Patient list 2 Use the Frequency knob to select...

Page 79: ... Connect to the device you wish to use for testing Click on the device you wish to use If the device is not listed check the check box My device is turned on and ready to be found and click on Search Test Type Show test type Click to enable viewing any of these test types as a test tab selection on the Audi ometry test screens If a User Test is set up to include either of these tests and they have...

Page 80: ...t device select Help About Device 9 1 Reconnecting to the device If the control panel for a test type is shown and communication with the selected test device is interrupted a message appears stating that there is no longer connection to the device Click the Connect button on the Control Panel to reconnect to the selected test device 9 2 Updating device firmware If the OTOsuite software version co...

Page 81: ...ADSEN Xeta cabinet 10 1 1 Fuses Warning Risk of fire Before replacing a fuse first switch off the instrument and disconnect it from the mains power supply The fuse holder is located above the AC power connector To remove a fuse Unscrew the end of the fuse holder using a screwdriver with a blade at least 6 mm wide Fuse types The fuse is a push fit in the end of the fuse holder When you replace fuse...

Page 82: ... audiometer headphones bone oscillators and sound field speakers must be calibrated once a year by your authorized service department The audiometer is dispatched from the factory together with a Test Report Calibration Certificate The Test Report spe cifies the transducers that have been calibrated i e those which have been supplied together with the instrument according to which standards and th...

Page 83: ...Calibration Certificate make sure that the transducers headphones and bone oscillators are the correct ones and that they comply with the ordered calibration standards 11 2 Storing If you need to store MADSEN Xeta before you put it into operation follow the guidelines below Store MADSEN Xeta and accessories in the boxes provided to protect the equipment from damage Store MADSEN Xeta and accessorie...

Page 84: ... Connecting to a pc 84 3 Switch on MADSEN Xeta 4 Run the Configuration Wizard in OTOsuite to connect to and set up communication with MADSEN Xeta See see Con figuring the Audiometry Module 79 11 3 1 Powering 1 Plug the power cord into the power socket of MADSEN Xeta See Socket connections rear panel 24 2 Plug the other end of the power cord directly into an AC mains power outlet with a three wire ...

Page 85: ...ion To verify the transducer used press Setup and select AC to view the transducer selected If required select the desired transducer 11 3 4 Bone conduction Connect the bone conduction transducer plug into the BC socket located in the rear panel of MADSEN Xeta See Socket connections rear panel 24 Otometrics MADSEN Xeta 85 11 Unpacking and installing ...

Page 86: ...11 Unpacking and installing 86 Otometrics MADSEN Xeta ...

Page 87: ... V AC 10 V DC Patient Mic Talk Back socket 12 V AC 12 V DC Patient responder socket 12 V AC 12 V DC AC mains inlet 1500 V AC 370 V DC 12 2 RS232 interface sockets pin 1 nc 240 V AC 240 V DC pin 2 RxDout 15 V AC 15 V DC pin 3 TxDin 30 V AC 30 V DC pin 4 DTR 30 V AC 30 V DC pin 5 ISO Gnd 30 V AC 30 V DC pin 6 DSR 30 V AC 30 V DC pin 7 RTSin 30 V AC 30 V DC pin 8 CTSout 15 V AC 15 V DC pin 9 nc 240 V...

Page 88: ...12 Maximum non destructive voltage 88 Otometrics MADSEN Xeta ...

Page 89: ...vel FM frequency modulation FREQ frequency HL hearing level INT internal INT interrupter L left LCD liquid crystal display LED light emitting diode LEV level MANU manual MASK masking MIC microphone MOD modulation NBN narrow band noise o right ear P parameters R right SIG signal SISI short increment sensitivity index SPL sound pressure level STEN Stenger THR threshold TON tone Otometrics MADSEN Xet...

Page 90: ...TRA transducer TRANSD transducer TTS temporary threshold shift VU volume unit WRB warble x left ear 90 Otometrics MADSEN Xeta 13 Abbreviations ...

Page 91: ... in the European Union Do not dispose of these products as unsorted municipal waste You can return your device and accessories to Natus Medical Denmark ApS or to any Natus Medical Denmark ApS supplier You can also contact your local authorities for advice on disposal Consult user manual for warnings and cautions Follow instructions for use Consult instructions for use MEDICAL General Medical Equip...

Page 92: ...that the use of such devices in the vicinity of MADSEN Xeta be restricted 9 There are no user serviceable parts inside the MADSEN Xeta cabinet 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 the equipment manufacturer or by service personnel at authorized workshops In case of any defects make a detailed desc...

Page 93: ... detailed information in the dialog box 14 4 Manufacturer Natus Medical Denmark ApS Hoerskaetten 9 2630 Taastrup Denmark 45 45 75 55 55 www natus com 14 4 1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety reliability and performance of the equipment only if All assembly operations extensions re adjustments modifications or repairs are carri...

Page 94: ...14 Standards and safety 94 Otometrics MADSEN Xeta ...

Page 95: ...ation FM Warble 1 20 Hz in 1 Hz steps Mod width 1 25 in 1 steps AM for SISI 5 4 3 1 0 75 0 50 0 25 dB HL steps Attenuator 5 dB HL step resolution over the entire range Attenuator accuracy In whole range better than 3 dB HL Between two consecutive attenuator positions 5 dB HL step better than 1 dB HL HL Range Maximum output will be limited by the transducer AC 10 to 120 dB HL at mid frequencies BC ...

Page 96: ...e frequency can be adjusted in the range 0 25 to 2 5 Hz in 0 25 Hz steps Timed The signal is presented for a preset period of time 0 25 to 2 5 seconds in steps of 0 25 seconds Static force of transducer headbands TDH 39 4 5 N 0 5 N B 71 5 4 N 0 5 N RS232 interface Format 8 data bit 1 stop bit Parity Equal Baud rate 9600 19200 38400 57600 Baud Protocol XON XOFF Transport and storage Mode of operati...

Page 97: ...ding to WEEE and local regulations Dimensions Approx 355 x 415 x 130 mm 14 x 16 5 x 5 1 inches Weight Approx 4 kg 8 8 lb Power supply Internal 100 120 V AC 200 240 V AC 50 60 Hz Power consumption 60 VA Fuses T 1 A H 250 V Standards Audiometer EN60645 1 and ANSI S3 6 Patient Safety Complies with IEC 60601 1 3 1 edition 2012 Class I Type B IEC 60601 1 6 2010 IEC 62366 2007 CAN CSA C22 2 NO 60601 1 2...

Page 98: ...d is thus subject to special safety precautions For this reason the installation and operating instructions provided in this document should be followed closely Portable and mobile high frequency communication devices such as mobile phones may interfere with the func tioning of MADSEN Xeta Guidance and manufacturer sdeclaration electromagnetic emissionsfor all equipment and systems MADSEN Xeta is ...

Page 99: ...ensure that it is used in such an envir onment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic dis charge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with syn thetic material the relative humidity should be at least 30 Power frequency 50 60 Hz magnetic field...

Page 100: ...Hz and 80 MHz are 6 765 MHzto 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHzto 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHzand 80 MHz and in the frequency range 80 MHzto 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Fo...

Page 101: ...d at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equa tion applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These g...

Page 102: ...15 Technical specifications 102 Otometrics MADSEN Xeta ...

Page 103: ...anaging the client list 52 menu bar 28 OTOsuite toolbar 28 Auto Threshold testing 19 Automatic Screening 19 B Baud rate setting 63 BC connection 24 25 BC transducer select bone conductors 62 Beep function 17 ON OFF setting 63 bone conduction BC transducer 62 Bone conduction BC connection 24 25 button 18 testing 70 Butterfly 59 60 Buttons 16 18 Air 17 Auto Screening 19 Auto Threshold 19 Bone 18 Cle...

Page 104: ... range button 19 timeout setting 61 F Fetch test results from audiometer 30 Firmware update test devices Aud 80 Fowler alternating tone frequency setup 20 selecting test 19 storing results 77 Frequency butterfly 59 60 change test f 22 change with STORE AC 59 change with STORE BC 60 changing 23 dB level for new f 60 pulse 62 select AC manual 59 select BC manual 59 selecting pure tone types 95 warbl...

Page 105: ... 15 Intended use 8 Interface cable connection 25 Interrupter specifications 96 L Left Right audiogram viewing 29 Legend box audiogram viewing 29 Level Lock Masking button 18 LR button 21 M Maintenance 81 replacing fuses 81 Manufacturer 93 Mask Lock buttonfront panel Level Lock Masking 18 Masking air conduction 72 buttons 18 masking assistant 13 select presentation 60 Masking assistant 13 enabling ...

Page 106: ...Mic 24 Talk over 23 Patient list 52 Patient responder 31 Patient response shown on front panel 22 switch connection 25 PC interface cable connection 25 Power switch 25 Preparing for testing connecting cables 46 inspecting the client s ear 50 Present signal left button 23 Presenting signal reversing function 18 Start Pause button 24 Pulsed button 18 R Records deleting 20 Replacement fuses 81 Respon...

Page 107: ... 20 Testing air conduction 67 Auto Threshold 19 Auto Screening 19 bone conduction 70 Extended Range 19 Tests controlling from Control Panel 33 optional tests 19 selecting tests 18 Tone screen Audiogram Module 36 Threshold automatic testing 19 store t 22 Timed button 18 Tone test the Tone screen Audiogram Module 36 Toolbar Audiometry 28 select orientation 30 Tools menu Curves and symbols 30 Tools m...

Page 108: ...d audiogram legend 29 combined audiogram 29 frequency range 30 masking assistant 29 Overlays 29 Voltage maximum non destructive 87 W Warble frequency 63 modulation size 63 Warble button 18 Warning notes 92 Wrap 59 60 108 Otometrics MADSEN Xeta Index ...

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