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CAPELLA Cochlear Emissions Analyzer

User Manual

GN Otometrics A/S

11

2

The

Capella

Hardware

2.1

Safety

2.1.1

Symbols

This User Manual contains information and warnings which must
be followed to ensure the safe performance of the

CAPELLA Cochlear

Emissions Analyzer

. Local government rules and regulations, if appli-

cable, should also be followed at all times.

Special note should be made of the following:

The

Capella

carries this symbol when it is important

that the user refer to associated warnings in this
guide.

The

Capella

and this manual are CE-marked according

to the Medical Devices Directive 93/42/EEC.

Classified with respect to electrical shock, fire, me-
chanical and other specified hazards in accordance
with UL2601-1 and CAN/CSA-C22.2 NO 601.1-90

Capella

is marked with this symbol to indicate compli-

ance with Type B requirements of EN 60601-1.

This class of equipment is allowed in domestic estab-
lishments when used under the jurisdiction of a
health care professional.

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Содержание MADSEN Capella

Страница 1: ...Cochlear Emissions Analyzer User Manual Doc no 7 26 5500 11 Part no 7 26 550 0459 ...

Страница 2: ...the prior written con sent of GN Otometrics A S Copyright 2011 GN Otometrics A S Printed in Denmark by GN Otometrics A S Denmark All information illustrations and specifications in this manual are based on the latest product information available at the time of publication GN Otometrics A S reserves the right to make changes at any time with out notice Version release date 8 September 2011 Technic...

Страница 3: ... up the system 10 2 The Capella Hardware 2 1 Safety 11 2 1 1 Symbols 11 2 1 2 Safety precautions 12 2 2 Installing the Capella hardware 12 2 2 1 Unpacking Capella 12 2 2 2 Storage and shipment 13 2 2 3 Inspection 13 2 2 3 1 Equipment supplied 14 2 2 3 2 Optional accessories 14 2 2 4 Installation 14 2 3 Care and maintenance 15 2 3 1 Probe 15 2 3 2 Eartips 17 2 3 2 1 Disposal 17 2 3 2 2 Portable use...

Страница 4: ...coustic Emissions SOAE 25 3 1 4 Echo Screen 25 3 1 5 Tympanometry immittance measurements 26 3 1 6 Power Supply 27 3 1 7 Patient Safety 27 3 1 8 Operating Environment 27 3 1 9 Storage Shipment Environment 27 3 1 10 EMC 27 3 1 11 Dimensions and Weight 28 3 2 Manufacturer 28 3 3 Starting up the system 28 4 Operation 4 1 Probe fit 29 4 2 ECHO SCREEN 30 4 3 TEOAE 31 4 4 DPOAE DP gram 32 4 5 DPOAE Inpu...

Страница 5: ...l and infant screening and TEOAE for clinical and diagnostic testing of all pa tients Tests include amplitude and input output determinations of Evoked emissions as well as spectral averages of Spontaneous emis sions A Tympanometry module is included for identifying hearing problems arising in the middle ear CAPELLA Cochlear Emissions Analyzer is operated by an IBM or com patible personal computer...

Страница 6: ...ked Otoacoustic Emissions Evoked emissions which occur in nearly all normal hearing ears are further divided into three sub types according to the nature of the acoustic stimulus used to elicit them Transient Evoked Otoa coustic Emissions TEOAE s occur in response to brief acoustic sig nals clicks tone bursts etc It has been suggested that they may be particularly well suited to detection of cochl...

Страница 7: ...the immittance of the middle ear associated with changing static pressure in the ear canal This pressure is swept through a predetermined range by means of a digitally driven pump The measurement techniques employed in Capella have several dis tinct advantages over more traditional audiologic tests 1 Objectivity No behavioural response is required from the patient 2 Time efficiency Some tests can ...

Страница 8: ...tion threshold and response amplitude frequency content and growth Outer hair cells OHC Basilar membrane Efferent innervation Capella complies with the following international standards Patient Safety Complies with EN 60601 1 Immittance testing Comparative tympanometry according to EN 61027 and ANSI S3 39 1 2 The NOAH fitting platform The Capella OAE application module may be integrated with HIM S...

Страница 9: ...iendly that we are convinced that you will find operation of Capella a very straightforward process The simplicity of the screen layouts together with online Help make the program very easy to use This manual describes Capella s hardware and accessories and also includes an Operation Guide to the application software Familiarity with Windows is assumed Note Program diskette is located at the back ...

Страница 10: ...ystem If Capella is running under NOAH first access NOAH s Client Mod ule On the toolbar only the first icon Client Module and the last icon Help are active until a client has been selected all the others are greyed inactive Before proceeding to any of the application modules it is first necessary to access the Client Module and then to either select an existing client or to add a client to the da...

Страница 11: ...the following The Capella carries this symbol when it is important that the user refer to associated warnings in this guide The Capella and this manual are CE marked according to the Medical Devices Directive 93 42 EEC Classified with respect to electrical shock fire me chanical and other specified hazards in accordance with UL2601 1 and CAN CSA C22 2 NO 601 1 90 Capella is marked with this symbol...

Страница 12: ... person carrying out the assembly must take into account that other connected equip ment which does not live up to the same safety requirements as this product may lead to a reduction in the overall safety level of the sys tem When selecting accessories connected to the RS232 socket the fol lowing points must be considered Use of connected equipment in a patient environment Evidence that connected...

Страница 13: ...ctory for service or repair please use the original shipping cartons as recom mended above All products returned to GN Otometrics or its repre sentatives must be shipped prepaid and insured or you must assume the risk of loss or damage in transit When shipping Capella please remember to 1 Seal the shipping container securely 2 Mark the container FRAGILE to ensure careful handling 3 Refer to the in...

Страница 14: ...le 8 Probe Connector Cable 9 Power Cord 10 Capella User Manual including program diskette 11 Calibration Adaptors 12 Fuse Kits Note Program diskette is located at the back of this manual 2 2 3 2 Optional accessories Echo Screen probe Eartip box with 2cc cavity Carrying Case Inkjet or laser printer Children s Headband M E Coupler B K Calibrator 8m Serial Interface Cable Service Manual 2 2 4 Install...

Страница 15: ...t Caution Operating at the wrong voltage may blow the fuses Plug one end of the supplied power cord into the power inlet on the back of Capella see Fig 1 below and plug the other end directly into a three wire protective ground AC power outlet Figure 1 For more information about installation set up the Capella software on your PC Section 3 3 Starting up the system on page 28 and then refer to the ...

Страница 16: ...ion away from the probe housing towards the tip of the probe 2 The probe should never be placed directly in water or other cleaning liquids Liquids seeping into the housing will dam age the probe 3 When fitting a new eartip to the probe ensure it is pushed all the way to the probe casing so there is no gap between the eartip and the casing The top should be flush with the end of the probe tip 4 Ca...

Страница 17: ...only one patient The eartips are in direct contact with your patients and you should therefore observe strict hygienic precautions to prevent passing infections from one patient to another It is therefore recommended that you use only disposable eartips Most eartips are disposable and should not be cleaned or re used Always throw away disposable eartips after use on a patient 2 3 2 1 Disposal Ther...

Страница 18: ...inside the instrument or probe Caution Chemical agents containing ammonia or alcohol will damage the cabinet Avoid exposing the instrument to direct sunlight and keep it well ventilated at all times to prevent overheating 2 4 Fuse replacement Two identical fuses are located in the connection panel between the power inlet and the on off switch To replace a fuse please proceed as follows 1 Disconnec...

Страница 19: ...ttery powered version The optional battery powered version of Capella utilizes a recharge able Ni MH battery pack The battery pack is located inside the Capella cabinet and is NOT to be accessed by unauthorized person nel If you experience any problems with recharging the battery pack or operation on battery power only please contact your local supplier 2 6 1 Battery replacement For authorized per...

Страница 20: ...y 5 to 7 hours of constant use up to 22 to 24 hours typical usage and up to 38 hours stand by i e powered on but not in use The life of the rechargeable battery pack depends on too many vari ables to be estimated but you are advised to follow the normal rules for maximizing battery life avoid constant recharging when not in use and completely exhaust the batteries periodically once every 6 months ...

Страница 21: ... the mains supply for a few seconds and then reconnect it 2 7 Service and repair Service and repair of electro medical equipment should be carried out only by the equipment manufacturer or by authorized repre sentatives The manufacturer reserves the right to disclaim all responsibility for the operating safety reliability and performance of equipment serv iced or repaired by other parties Followin...

Страница 22: ...ich have been supplied together with the instrument according to which stand ards and what equipment was used for calibration Results are list ed for each transducer at all standard frequencies For DPOAE Capella is calibrated in dB SPL 1 dB SPL 20 µPA for TEOAE Capella is calibrated in dB peak Calibration has been performed on the supplied probe If you wish to use any other probe for testing with ...

Страница 23: ...nstructions to the hardware platform and collects data from the hardware platform Includes a comprehensive on line Help to assist the user 6 Various cords and cable connections including an RS232C computer interface 7 This User Manual which provides general information about the theory and technique involved in the measurement of otoacoustic emissions as well as specific instruction in the use of ...

Страница 24: ...Hz 13 02 kHz 5 kHz 6 Hz 6 51 kHz 2 5 kHz 3 Hz Frequency Response Accuracy Microphone 3 dB from 500 to 4000 Hz 6 dB from 4000 to 9000 Hz Sound Level 711 Coupler Reference volume compensated 4 dB from 500 to 4000 Hz 7 dB from 4000 to 9000 Hz In Situ Sound Level Adjustment 4 5 dB from 500 to 4000 Hz 3 1 2 Transiently Evoked Otoacoustic Emissions TEOAE Stimulus Non linear 3 clicks of the same polarity...

Страница 25: ...ear click Signal bandwidth 1 4 to 4 kHz Max sound pressure Limited to 85 dB SPL Probe Eartips from 4 to 10 mm dia Signal processing Binomial statistical analysis of TEOAE sweeps for signal to noise ra tio 99 confidence level analysis of a time window from 6 to 12 ms after the stimulus ranked in four quality buffers Result display Pass or Refer based on the acquisition of four pos and four neg peak...

Страница 26: ...26 Hz at 85 dB SPL and 1000 Hz at 75 dB SPL selectable Volume range 0 1 to 8 ml Y axis scaling 0 3 0 6 0 9 1 5 3 4 5 ml and Auto Smoothing On off selectable before or after measurement Sweep start From probe from screen or automatic when volume detected Leak detect On off selectable Air release From screen or from keyboard or automatically if pressure exceeds 800 daPa or 600 daPa Measurement statu...

Страница 27: ... B IPX0 Battery version complies with EN 60601 1 Class I Internal Pow ered Type B IPX0 3 1 8 Operating Environment Mode of operation Continuous Temperature 10 35 C Relative Humidity 30 90 non condensing Atmospheric Pressure 600 1090 hPa Operation in temperatures exceeding 20 C or 60 C may cause permanent damage 3 1 9 Storage Shipment Environment Temperature 20 C to 60 C Relative Humidity 30 90 non...

Страница 28: ...les it is first necessary to access the Client Module and then to either select an existing client or to add a client to the database You are referred to the NOAH or PAX User s Guide for detailed nav igation instructions After having selected or added a client click on the Selection of Measurement Module icon which opens the NOAH PAX Measure ment Selection Screen Double click on the Capella button...

Страница 29: ... This measure ment only All measurements for current mode and cur rent ear All measurements for current ear all modes or Selected measurements If necessary select the measurements to be moved from the list and then click on OK To clear all measurement data for all modes and for both ears from the current session select Clear all in the File menu or click on the Clear all icon in the toolbar When t...

Страница 30: ...e measurement screen allows you to monitor the status of the probe fit Green indi cates a good fit yellow indicates an acceptable fit and red indi cates a poor fit or that the probe fit procedure was not carried out 4 2 ECHO SCREEN 1 Click on the Echo Screen icon or choose Echo Screen in the Mode menu 2 Press Start to begin screening 3 When the screening is complete the Result will display green f...

Страница 31: ...shown in each of five frequency bands as well as the broad band values The blue vertical bar on the right of the time response graph also indicates the noise floor during the measurement 7 Click on Stop to end the measurement if you have disabled Stop criteria 8 Scaling of the time response graph can be changed by using the up and down arrows in the Scale box on the screen or the PgUp and PgDn key...

Страница 32: ...or to view other measurements made on the same ear during the session 12 Repeat the procedure beginning with Probe fit for measuring the other ear 4 4 DPOAE DP gram 1 Click on the DP Gram icon or choose Distortion Products DPOAE in the Mode menu and DP Gram in the submenu 2 Select Parameters in the Setup menu to define the Level Difference between f1 and f2 select either 2f1 f2 DP1 or 2f2 f1 DP2 f...

Страница 33: ...t measurement will automati cally resume on the next preselected frequency 6 Click on Stop to end the measurement if you have disabled Stop criteria To resume measurement on the next prese lected frequency click on Start 7 If you wish to halt the measurement momentarily click on Pause Click on Cont to resume the measurement at the same frequency 8 Measurement status can be monitored by observing t...

Страница 34: ...The default pattern showing normative data in the DP Gram display is for adults measured at the University Hospital of Copenhagen To show the corresponding pattern for babies instead select Norm data in the Setup menu and click on baby Amongst the other normative data patterns which may be selected from this dialog box is the Gorga norm Confirm the selected norm by clicking on OK The normally gree...

Страница 35: ...rt to begin measuring 5 If you wish to halt the measurement momentarily click on Pause Click on Continue to resume the measurement 6 Measurement status can be monitored by observing the Sweeps and Statistics boxes on the lower right part of the screen The noise floor during the measurement is also indi cated by the blue vertical bar to the right of the DP Gram The normally green DP dot turns yello...

Страница 36: ...pectrum to view other frequencies 7 Move the cursor by using the left and right arrow keys on the keyboard by clicking on the arrow keys in the Cursor box on screen or by clicking on the response spectrum itself at the point where you want to position the cursor 8 Click on Next to identify the next SOAE according to the defined S N criteria The spike will be marked on the graph with and data liste...

Страница 37: ...top when results available select Parame ters in the Setup menu and choose different settings as required 4 Select probe tone in the Frequency box 5 To prevent the sweep from restarting if a leak is detected click Off in the Leak detect box 6 If auto start has not been selected click on Start to begin the sweep If a leak halts the sweep or the Pump position displayed during the sweep is seen to re...

Страница 38: ...d mode and then click on OK 4 9 Comments You can append comments by selecting Edit comments from the File menu 4 lines of comments can be written per session These comments are displayed on NOAH s session list and can be includ ed on the printout 4 10 User configuration 1 From any measurement mode all setup and test parameters can be saved as a specific user configuration Select User in the Setup ...

Страница 39: ...ent can be interrupted at any time by clicking on Pause or the Auto sequence can be terminated prematurely by clicking on the Stop button in the Auto Sequence run box 3 To create a new macro type a name into the New Auto sequence box and then click on New Select the measure ment modes you wish to test with type the number in the sequence under Mode order choose the Number of meas urements you wish...

Страница 40: ... s ear over time 1 Select Compare from the File menu 2 Choose TEOAE DP Gram or DP I O from the Mode menu as required 3 Click on Open session in the File menu to find the data to be compared 4 Click on the first session to be compared then on OK and then select another measurement if required by means of the left or right arrows in the Session sub window 5 Repeat step 4 up to five times Each succes...

Страница 41: ...nd then This mode Overview or All To configure a new print setup or select a different existing named setup Load Setup select Print layout in the File menu Portrait or landscape format may be set up by clicking on Select Printer To add an image to the current page proceed as follows 1 Click on the arrow to the right of the selection bar at the top of the dialog box 2 Click on the required image 3 ...

Страница 42: ...42 GN Otometrics A S User Manual CAPELLA Cochlear Emissions Analyzer ...

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