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Appendix 5: Audiometric Standards

The TympStar Pro is designed to meet or exceed the following standards:

Aural Impedance/Admittance Instrument Standard Requirements - Type 1

ANSI S3.39 (1987) Specification for Instruments to measure Aural
Acoustic Impedance and Admittance (Aural Acoustic Immittance)

IEC 60645-5 (2004) Electroacoustics - Audiometric Equipment –
Instruments for the measurement of aural acoustic impedance/admittance

ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and
Insert Earphones

ISO 389-4 Reference Levels for Narrow-Band Masking Noise

Summary of Contents for TYMPSTAR PRO

Page 1: ...andard www grason stadler com Grason Stadler 10395 West 70th Street Eden Prairie MN USA 55344 800 700 2282 952 278 4402 fax 952 278 4401 e mail info grason stadler com GSITYMPSTAR PRO USER MANUAL Part...

Page 2: ...D 0105594 Rev G i...

Page 3: ...tion in this publication is proprietary to Grason Stadler This product incorporates software developed by others and redistributed according to license agreements Copyright notices and licenses for th...

Page 4: ...wnout and Interruptions 7 Warning Connections 7 Warning Battery Safety 7 Cautions General 7 Shutdown Procedure 7 Recycling Disposal 8 Customer Responsibility 8 Warranty 9 Chapter 1 Introduction 10 Ind...

Page 5: ...top 24 Start 24 Pressure Control 24 Reflex Stimulus Controls 25 Stimulus 25 Intensity 25 Present 25 Print 25 Data Transfer 27 Configure 27 Chapter 5 Test Type Displays 29 Display Monitor 29 Test Type...

Page 6: ...s 103 Calibration Quick Check for Probe 103 Biological Calibration Check 105 Preventive Maintenance 105 Cleaning the System 105 Cleaning and Disinfecting Agents 106 Cleaning patient contact devices 10...

Page 7: ......

Page 8: ...G label identifies conditions or practices that may present danger to the patient and or user CAUTION The CAUTION label identifies conditions or practices that could result in damage to the equipment...

Page 9: ...of Manufacture Attention consult accompanying documents China RoHS symbol for products with a 50 year life cycle B Patient Applied Part according to IEC 60601 1 On Off Next to power mains Keep Dry Thi...

Page 10: ...directions for use A copy of the operating manual is available on this website www grason stadler com A printed copy of the operating instructions can be ordered from Grason Stadler for shipment withi...

Page 11: ...he direct supervision by the aforementioned specialist Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appr...

Page 12: ...ts in excess of those allowed by the standard and present a potential electrical shock hazard to the person being tested This icon indicates that the TympStar Pro is in compliance with Class 1 Type B...

Page 13: ...amage to the power unit Follow all safety standards set by each place of employment NOTE If the instrument is connected to a PC power to the monitor and computer must be controlled by the isolation tr...

Page 14: ...setup instructions Switch off the system power before connecting or disconnecting any system component s or accessories Warning Battery Safety This instrument contains a coin type lithium battery for...

Page 15: ...may be broken or missing or are visibly worn distorted or contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from GSI This product should no...

Page 16: ...ler facility If field service is requested there will be no charge for labor or material however there will be a charge for travel expense at the service center s current rate NOTE Changes in the prod...

Page 17: ...plugged at the entrance or if fluid is running from the ear canal tympanometry should not be attempted until the condition is cleared Testing should not be performed on patients with conditions liste...

Page 18: ...s subjected to varying degrees of stress which alters mobility of the eardrum Maximum mobility will occur when the pressure on both sides of the eardrum are equal Changes in mobility of the eardrum te...

Page 19: ...Latency Test Multiple Frequency Tympanometry 250 Hz to 2000 Hz Operators have a choice of using GSI preprogrammed test parameters or programming customized test criteria A large touch enabled liquid...

Page 20: ...iginal container if possible and return it prepaid to the factory for the necessary adjustments NOTE Keep the original packing material and shipping container so the instrument can be well packaged if...

Page 21: ...he factory default test mode to set user defined power up setting see the information regarding the PC configuration software and the probe green lamp will begin to blink indicating that the instrumen...

Page 22: ...scription Graphic B1 Mains Power Input IEC 14 WARNING To avoid the risk of electric shock this equipment must only be connected to supply mains with protective earth B2 USB Computer Connection USB B s...

Page 23: ...resolution in order to maintain the aspect ratio of the tympanogram B6 Patient Response Inputs 6 35 mm mono jack for hand switch B7 DC output DC connection 2 1 mm only for use with the 4 Sanibel prin...

Page 24: ...ive for upgrades USB Ports The TympStar Pro is equipped with four 4 USB ports 3 ports on the back of the instrument 2 USB Type A 1 USB Type B and one on the right side USB Type A It is possible to con...

Page 25: ...nded to always have the USB ports enabled on the PC Disable the suspend USB power option on the PC Left Side Panel The connector to the probe box assembly is on the left side panel of the TympStar Pro...

Page 26: ...hanical hazards only in accordance with UL 60601 1 Classified under the Medical Device Directive 93 42 EEC as a Class IIb device 0123 Conforms to European Medical Device Directive 93 42 EEC Manufactur...

Page 27: ...GSI Part number Return to authorized representative special disposal required Manufacturer...

Page 28: ...tor to change the ear being tested and to start and stop the test The selected ear is indicated on the screen and on the probe box as the ear that has the light There is Velcro on the back of the box...

Page 29: ...pplication Patient The PATIENT button displays Patient screen and allows the examiner to create a new session and enter patient demographics The Patient List screen allows the user to select a patient...

Page 30: ...tions as a toggle to switch between reflex threshold growth and reflex decay ETF The ETF key displays the Eustachian Tube Function Test screen This button functions as a toggle to switch between the I...

Page 31: ...direction of the pressure change is indicated by the arrow The left button changes the pressure from positive to negative and the right button changes the pressure from negative to positive The press...

Page 32: ...to allow printing of the tympanometric test results directly The printer must be HP PCL3 HP PCL5E HP PCL3 GUI or TSPL compatible If a USB memory stick is inserted into an available USB port print to P...

Page 33: ...st options indicate the data that will be printed and the user may choose between the selected tab the marked tabs or all tabs A single ear or both ears may be selected Printout The printout settings...

Page 34: ...btained from GSI or an authorized GSI representative A message is displayed if no USB disk is found Print Settings Selecting the button displays a printer settings dialog to select the printer protoco...

Page 35: ...4 paper sizes 3 roll paper for the Sanibel printer and the LPQ 80 and 3 labels for the LPQ 80 Print Button Action o Screen Print prints the data displayed on the screen o Summary Print prints the mark...

Page 36: ...ion displayed on the TympStar Pro LCD varies depending on the Test Type There are common elements found on all screens such as the Ear Tab Probe Status indicator Admittance meter Pressure meter the Te...

Page 37: ...ters that may be changed in analysis You may change the baseline view or the immittance component on the test menu In the settings menu you may change the display options These parameter changes will...

Page 38: ...s the settings dialog The settings dialog displays the user selectable parameters for the specific test type Comments Icon The comments icon pencil opens a comments window An external keyboard is used...

Page 39: ...eening results are those that will be transferred to GSI Suite or printed directly from the device Only a single screening result per probe tone frequency may be marked A total of four screening resul...

Page 40: ...ays the real time admittance as it is being recorded from the probe in the ear canal The units are millimhos mmho The current value is displayed at the top left of the meter The pressure meter display...

Page 41: ...application TympStar Pro Config App Reflex Parameter Buttons Up to four reflexes may be recorded on the Screener display and there are two parameter buttons for each reflex For each reflex the choice...

Page 42: ...Start check box determines if the test starts automatically upon obtaining a seal When the box is checked the tympanogram data collection begins as soon as a seal is obtained When the box is not check...

Page 43: ...the cursor may be moved to a different point on the waveform by touching the waveform at the desired point or by using the manual pressure knob on the instrument to move right and left on the waveform...

Page 44: ...fined in the PC Config App The device default settings can be found in the Appendix Comments The comments icon opens a comments window An external keyboard is used to enter comments Comments may be en...

Page 45: ...m that will be transferred to GSI Suite or printed directly from the device The peak pressure of the marked tympanogram is used to set the pressure for conducting the acoustic reflex tests Only a sing...

Page 46: ...internal error on the device Admittance and Pressure Meters The admittance meter displays the real time admittance as it is being recorded from the probe in the ear canal The units are millimhos mmho...

Page 47: ...daPa and admittance mmho value of the indicated peak of the tympanogram The Tymp Measure t column displays the tympanometric width daPa or gradient mmho The gradient option is selected from the Setti...

Page 48: ...button is pressed a submenu is displayed where the user may choose between the Admittance Y and the two components of Admittance Susceptance B and Conductance G and the combined graph showing both B a...

Page 49: ...f the dialog The crosshairs of the cursor may be moved to a different point on the waveform by touching the waveform at the desired point or by using the manual pressure knob on the instrument to move...

Page 50: ...Start Pressure The Start Pressure Test Options button is used to select the starting pressure daPa for collecting a tympanogram When the button is selected a dropdown list of starting pressures is pre...

Page 51: ...a will display when Baseline Configuration is set to Auto or Negative Tail When Baseline Configuration is set to Positive Tail the normative data box will display only when Baseline is off NOTE Normat...

Page 52: ...rent protocol is shown in the Protocol button When the button is pressed the list of available protocols is presented The tests included in the protocol are displayed to the right of the button The au...

Page 53: ...reflex graph The tabs at the top of the graph are used to select the ear to be tested The area to the right of the graphic area displays the admittance and pressure meters along with the eliciting sti...

Page 54: ...ot set NS Not set indicates no threshold was selected and the test has not been marked as no response For tests that are not set selecting the threshold or marking as a no response is required to indi...

Page 55: ...controlled and is defined in the reflex settings dialog Reflex Test Menu Auto Zero The Auto Zero menu option automatically sets the admittance to zero when the key is pressed The system automatically...

Page 56: ...pied from the collection area to the stored display area Only a single reflex per stimulus may be stored If you try to store a new reflex when a similar reflex has already been stored you will be prom...

Page 57: ...lex stimulus The Mark No Response button selects the curve and marks the test as a No Response The Set Peak button sets the current point as indicated by the cross hairs as the peak of the curve The F...

Page 58: ...n using the threshold seek function Start Level The Start Level Threshold Seek Option button is used to select the initial stimulus level dB HL for the reflex threshold testing when the threshold seek...

Page 59: ...that indicates a reflex threshold The buttons are used to increase decrease the level When the reflex reaches the threshold testing is stopped and the level dB HL where the threshold was found and ver...

Page 60: ...antity The Quantity Option is used to set the number of reflexes per stimulus The reflex may be repeated and all the reflexes are displayed The buttons are used to increase decrease the number of time...

Page 61: ...l reflex decay tests The reflex collection data are displayed as graphs with different probe tones stored as tabs on the left side of the reflex graph The tabs at the top of the graph are used to sele...

Page 62: ...the real time admittance as it is being recorded from the probe in the ear canal The units are millimhos mmho The current value is displayed at the top left of the meter The pressure meter displays t...

Page 63: ...tomatically sets the admittance to zero when the reflex test is started and when the stimulus is presented Probe The Probe button controls the probe tone frequency used for recording the reflex The bu...

Page 64: ...ns to scroll the waveform and change the magnification Store The Store menu option saves the selected reflex graph The graph is copied from the collection area to the stored display area Only a single...

Page 65: ...anel button is pressed When the button is selected a dropdown menu of options is presented Level dB Step The dB Step Level Option button is used to select the level dB step when the front panel button...

Page 66: ...cts the immittance component that is displayed on the graph The button displays a menu to select one of the following Admittance Y and the two components of Admittance Susceptance B and Conductance G...

Page 67: ...es stored as tabs on the left side of the reflex graph The tabs at the top of the graph are used to select the ear to be tested The area to the right of the graphic area displays the admittance and pr...

Page 68: ...mittance as it is being recorded from the probe in the ear canal The units are millimhos mmho The current value is displayed at the top left of the meter The pressure meter displays the real time pres...

Page 69: ...he admittance to zero when the reflex latency test is started and when the stimulus is presented Probe The Probe button displays the probe tone frequency used for recording reflex thresholds Stimulus...

Page 70: ...Zoom menu option displays the zoom dialog The zoom dialog provides a magnified view of the averaged reflex latency data and displays the time and admittance values for the selected point The dialog h...

Page 71: ...view The close button returns to the ARLT test screen Settings The Settings menu option may be used to define the parameters used to collect the reflex latency A Settings dialog is presented with the...

Page 72: ...from the marked points Norris et al Latency Measures of the Acoustic Reflex Audiology 13 464 469 1974 Timing The Timing buttons select the on time for the presentation of the stimulus for the reflex...

Page 73: ...sceptance B and Conductance G Comments The comments icon opens a comments window you must use external keyboard to enter comments Comments may be entered from any test screen and it is possible to rev...

Page 74: ...ing an intact Eustachian tube function test The collected data tympanograms are displayed with different probe tones stored as tabs on the left side of the graph The tabs at the top of the graph are u...

Page 75: ...on the device Admittance and Pressure Meters The admittance meter displays the real time admittance as it is being recorded from the probe in the ear canal The units are millimhos mmho The current val...

Page 76: ...Test Menu Continue The continue button starts the next tympanogram in the sequence after the initial tympanogram has been collected The instruction box indicates when it is appropriate to press the co...

Page 77: ...ed to select the sweep rate daPa sec for the pressure change when collecting a tympanogram The button label indicates the current setting When the button is selected a submenu of options is presented...

Page 78: ...f the dialog The crosshairs of the cursor may be moved to a different point on the waveform by touching the waveform at the desired point or by using the manual pressure knob on the instrument to move...

Page 79: ...Pressure Test Options button is used to select the starting pressure daPa for collecting a tympanogram When the button is selected a dropdown list of options is presented Range The Pressure Range Tes...

Page 80: ...lculated at the positive tail When Negative Tail is selected Vea for all probe tones is calculated at the negative tail Peak Indicator The Peak Indicator Display Options button determines if the tympa...

Page 81: ...information for conducting a perforated Eustachian tube function test Multiple tests may be collected and the collected data sets are stored as tabs on the left side of the graph The tabs at the top...

Page 82: ...Green Ready Solid Green Test in Progress Blinking Green Hold ready to continue test Solid Amber Occlusion Blinking Amber Leak or possible internal error on the device Pressure Meter The pressure mete...

Page 83: ...limit When the menu option is selected a sub menu of choices is presented When the test starts it will increase decrease the pressure of the ear canal until the maximum level is reached Time The Time...

Page 84: ...n Tube test Multiple tests may be collected and the collected graphs with different probe tones are stored as tabs on the left side of the graph The tabs at the top of the graph are used to select the...

Page 85: ...ar canal The units are millimhos mmho The current value is displayed at the top left of the meter The pressure meter displays the real time pressure as it is being recorded from the probe in the ear c...

Page 86: ...llection area to the stored display area Multiple test results per test condition may be stored A maximum of 8 stored test results may be saved Zoom The Zoom magnifying glass icon menu option displays...

Page 87: ...option may be used to define the parameters used to collect the Patulous ETF test results A Settings dialog is presented with the parameters that are available The Patulous ETF default settings are de...

Page 88: ...lected a dropdown list of options is presented Immittance Immittance Component The Immittance button selects the immittance component that is displayed on the graph The button toggles between the Admi...

Page 89: ...entative if an error message occurs when accessing this test _________________________________________________________________ The Multi Hz screen presents information for conducting a single multiple...

Page 90: ...ch the LED lights on the probe box The probe may be in the following states Indicator Lights Status Blinking Green Ready Solid Green Test in Progress Solid Green Hold ready to continue test Solid Ambe...

Page 91: ...stic equivalent volume in cm3 The Peak column displays the pressure daPa and admittance mmho value of the indicated peak of the tympanogram Tab 2 Delta Peak Start Tab 2 contains two graphs The top gra...

Page 92: ...daPa are also displayed Tab 3 Tympanogram at Resonant Frequency The tympanogram obtained at resonant frequency is displayed in the graph immittance component B The table on lower right side of the gra...

Page 93: ...n 250 and 2000 Hz in 50 Hz increments Select Tymp Tab 4 and press the buttons or drag the slider bar until the desired tympanogram appears Repeat for Tab 5 and 6 if desired The Tymp Tables display the...

Page 94: ...changed on the analysis For Multi Hz testing the baseline defaults to off Sweep Rate The Sweep Rate button is used to select the sweep rate daPa sec for the pressure change when collecting a tympanog...

Page 95: ...eft and right arrow buttons are used to scroll the waveform The and magnifier buttons increase and decrease the magnification The crosshairs of the cursor may be moved to a different point on the wave...

Page 96: ...o define the parameters used to collect the Multi Hz test data A Settings dialog is presented with the available parameters The Multi Hz default settings may be defined in the PC Config App The device...

Page 97: ...range is from 400 daPa to 600 daPa Normative Data The Normative Data Display Options check box is used to display the normative data box for the 226 Hz tympanogram The tympanogram must be baseline adj...

Page 98: ......

Page 99: ...ts that come into direct contact with the patient are subjected to standard disinfecting procedures between patients This includes physically cleaning and using a recognized disinfectant Individual ma...

Page 100: ...de as the ear to be tested The Velcro strip should be facing away from the body The probe box is then positioned on front of the Velcro strip Probe Insertion Ear canal examination with an illuminated...

Page 101: ...The options for the defaults for each test type are set up in the PC configuration software TympStar Pro Config App Tympanometry 1 Select the Tympanometry mode by pressing TYMP button on the front pan...

Page 102: ...ompletion of the sweep The user may abandon automatic testing by pressing the STOP button at any point for difficult to test patients 9 Upon completion of a pressure sweep numeric values for complianc...

Page 103: ...lamp on the probe box and indicator on the device screen changing from blinking to steady 9 View ongoing test results on the graphic display area and on the pressure and admittance meters After presen...

Page 104: ...ated into multiple sections The sections are presented as an expandable list on the left side of the application Subsections are displayed when the individual section is expanded The Instrument sectio...

Page 105: ...ords may be entered under the Instrument Security sections of the Config App software Examiner Passwords are user defined and may contain any combination of lower or upper case letters and numbers The...

Page 106: ...up here Reflex Decay The reflex decay section contains the settings for collecting acoustic reflex decay In addition to the test parameters the scaling defaults are set up here ARLT The ARLT section c...

Page 107: ...A set of tests that may be run in a sequence are setup in the Auto Sequence protocol The tests in the protocol may include diagnostic tests...

Page 108: ...ument Services USB that was included in the original shipment of the TympStar Pro or contact your GSI representative Data Port Direct The Data Port provides backwards compatibility with the TympStar s...

Page 109: ...ment fitting Noah 4 may be installed as standalone software or on a network Data transfer and storage utilizes the Noah database for data management AudBase AudBase software saves audiometric data fro...

Page 110: ...repairs be performed by a qualified GSI service representative only Malfunctions resulting from improper maintenance or repair by anyone other than an authorized GSI representative will be the respons...

Page 111: ...panogram should be identical other than the Vea should read 2 0 cm3 The same sequence may be followed with the 5 0cm3 opening on the test cavity Keep a copy of the tests for a day to day reference in...

Page 112: ...mmended that the instrument is cleaned at least annually Grason Stadler upon request will provide circuit diagrams component part lists descriptions calibration instructions or other information to as...

Page 113: ...up over time causing dull screens Never spray or otherwise apply any solution directly to your display It could leak into the device and damage electronic parts Cleaning and Disinfecting Agents Accor...

Page 114: ...ased cleaners Gently wipe the items with the slightly damp cloth taking care not to get moisture in the speaker portion of the probe and contralateral earphones The eartips for the probe are for singl...

Page 115: ...2 Take off the probe tip Note the gasket inside the tip 3 Thread the stiff end of the cleaning brush into one of the tubes from inside...

Page 116: ...each of the four tubes Discard floss after use NOTE Only insert the thread from the inside out this will insure that the dirt is pushed out of the probe instead of into the probe and as well protect...

Page 117: ...ool is useful for removal of cerumen that was not removed using the floss The wire on this tool can assist in pushing out the cerumen from each of the four tubes The metal loop on the end of this 3 in...

Page 118: ...e outside for each the four tubes of the probe tip Do not use the brush end of this tool to clean the probe tip instead use the cleaning floss 3 After the cerumen has been removed reassemble the probe...

Page 119: ...1500 Altitude Units Feet Default Ear Right Initial Screen Tympanometry Contralateral Ear Side Probe Contralateral Transducer Insert Tympanometry Types Y A A d A dd A s B C D E Tympanometry Types B G...

Page 120: ...r Off Reflex Settings Probe Tone 226 Hz Immittance Component Y Reflex Ear Ipsi Reflex Frequency 500 Hz Reflex Stimulus Type Pulsed Reflex Averages 1 Reflex Stimulus Quantity 1 Time Base 15 sec Stimulu...

Page 121: ...Start Off Baseline Off Sweep Rate 50 daPa sec Age Adult Normative Data 226 Hz Tab 1 Off Peak Indicator On Pressure Range Normal Start Pressure 200 daPa Immittance B Delta Peak Start Resonant frequency...

Page 122: ...ay 1 Tymp Probe 226 2 Reflex Ipsi 500 Pulsed Off 3 Reflex Ipsi 1000 Pulsed Off 4 Reflex Ipsi 2000 Pulsed Off 5 Reflex Ipsi 4000 Pulsed Off 6 Reflex Contra 500 Pulsed On 7 Reflex Contra 1000 Pulsed On...

Page 123: ...of Measurement Tymp mode at 226 Hz Probe Tone 0 1 mmho or 5 whichever is greater Reflex mode at 226 Hz Probe Tone 0 02 mmho or 5 whichever is greater Signal level accuracy 1 5 dB SPL Temporal Characte...

Page 124: ...Probe RETSPL Contra Insert RETSPL Contra Headset 250 24 5 14 0 27 0 500 9 5 5 5 13 0 1000 6 5 0 0 6 0 2000 12 3 0 8 0 4000 3 5 5 5 9 0 Broad Band Noise 7 0 7 0 7 0 Low Band Noise 9 0 9 0 9 0 High Band...

Page 125: ...l lose their calibration The frequency of the external stimulus must be carefully selected for the probe tone with which it will be used If the stimulus is too close to the probe tone frequency a stim...

Page 126: ...ins Operation Input Voltage 100 240 VAC Input Frequency 50 60 Hz Power Consumption 60 Watts Maximum Average Operating Current Idle 220 mA Average Operating Current Running Test 290 mA Heat Generation...

Page 127: ...Depth 16 5 cm 6 5 in Weight 5 7 kg 12 6 lb Physical Instrument Height 37 cm 14 5 in Width 41 cm 16 in Depth 28 cm 11 in Weight 5 5 kg 12 lb Probe Shoulder Box Height 9 9 cm 3 875 in Width 6 4 cm 2 5...

Page 128: ...d the curve in the scratch pad is selected then stored as a threshold To select a curve on the scratchpad the curve is touched on the LCD or clicked with the mouse If there is no curve selected and th...

Page 129: ...ctromagnetic Compatibility Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid unnecessary exposure to electromagnetic fields e g from mobile phones etc...

Page 130: ...which radiated RF disturbances are controlled The customer or the user of the TympStar Pro can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile...

Page 131: ...ferential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial hospital or residential environment Voltage Dips Short Interruptions...

Page 132: ...d RF transmitters as determined 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 Note 1...

Page 133: ...equirements as specified in IEC 60601 1 2 it is essential to use only the following accessories Item Manufacturer Item TympStar Pro Probe Grason Stadler 8104117 IP30 Contra earphone RadioEar 8101894 D...

Page 134: ...1987 Specification for Instruments to measure Aural Acoustic Impedance and Admittance Aural Acoustic Immittance 2 IEC 60645 5 2004 Electroacoustics Audiometric Equipment Instruments for the measuremen...

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