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Standards, Specifications, and
Accessories

Standards and Compliance

The TM286 meets

Tympanometry modes

Standards:

UL 60601-1 Medical Electrical Equipment Requirements for Safety

IEC/EN 60601-1 General Requirements for Safety

CSA C22.2 No.601-1-M90

ANSI S3.39-1987 Aural Acoustic Impedance Admittance (Type 3)

IEC 60645-5 Aural Acoustic Impedance/ Admittance (Type 2)

ANSI S3.6-2004 Audiometers (Type 4)

IEC 60645-1 Pure Tone Audiometers (Type 4)

GL2005-00014 (ASHA 2005) Guidelines for Manual Pure-Tone

Threshold Audiometry

Protective Classification:

This system is intended for continuous operation and has a protective

classification of Class 1.

Class 1 Type B

Probe Tone:

226 Hz, ±2%

Sound Pressure Level:

226 Hz: 85.5 dB SPL, ±2.0 dB, measured in a 2.0 cm

coupler

Harmonic Distortion:

<3%

Admittance (Compliance) Range:

226 Hz: 0.0 to 1.5 cm

or 0.0 to 3.0 cm

Notes:

1. The range is automatically selected based upon the amplitude of the
compensated tympanogram.
2. The maximum uncompensated (ECV + tympanogram peak) admittance
(compliance) range is 0 to 5.0 cm

3. ECV/cavity limits for initiating pressurization is 0.2 to 5.0 cm

Compliance Accuracy: ±0.1 cm

or ±5%, whichever is greater.

Содержание TM286

Страница 1: ...Tymp Directions for use Part Number 28603 Rev D Ref ANSI S3 6 ISO 389 dB HL Hz M 10dB R L AUD AUD FM TYMP 226 Hz 1 kHz TYMP REFLEX IPSI CONTRA PROG 500 Hz 1000 Hz 2000 Hz 4000 Hz 1 5cm3 R ECU cm 3 daP...

Страница 2: ...rica copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in t...

Страница 3: ...e 33 Program Mode Menu Items 33 Program Menu Page 1 Option Descriptions 34 Program Menu Page 2 Option Descriptions 40 5 Routine Maintenance 43 PreTest Tymp checks 43 6 Test Results 51 Ear Canal Volume...

Страница 4: ...iv Welch Allyn TM286 Auto Tymp Intensity Levels 63 Tone Format 64 Printer 64 Power 64 Environmental 64 Mechanical 65 Head set 65 Electromagnetic Compatibility 65 Accessories 66 Bibliography 67...

Страница 5: ...materials so that the claim adjuster can inspect it as well As soon as the carrier has completed the inspection notify a Welch Allyn representative If the instrument must be returned repack it careful...

Страница 6: ...per 4 wide 3 rolls shipped with system 26240 TM Dust Cover 05260 U TM Carrying Case 23221 Audiometry Single Patch Cord 2 Conductor 23220 Audiometry Patient Response Switch 23222 Audiometry AudioCups W...

Страница 7: ...ropriately trained individuals WARNING This symbol indicates the location of a service adjustment part and is intended for service personnel only The TM286 is a specifically calibrated audiometer and...

Страница 8: ...ING This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts A defective...

Страница 9: ...difference between the ear canal and the middle ear space Compliance using a 226 Hz probe tone is measured with respect to the ability of an equivalent volume of air to conduct sound and the scientif...

Страница 10: ...es contract they stiffen their respective ossicular chains This stiffening of the ossicular chain reduces the compliance of each middle ear system When the stimulus is presented to the same ear as the...

Страница 11: ...e entire auditory pathway Screening audiometry provides a method to determine an individual s ability to hear a test signal at a particular intensity level or at the lowest possible intensity level wi...

Страница 12: ...with normal middle ear function 150 daPa to 100 daPa 0 2 cm3 to 1 4 cm3 per ASHA 32 Supl 2 1990 17 24 only available on 226 Hz probe tone testing Pressure Peak Pressure value where maximum mobility oc...

Страница 13: ...2 9 Installation Printer and Display Figure 1 TM286 major component identifications Figure 2 Probe LCD Printer Paper cover Probe holder Probe cable connector Probe...

Страница 14: ...er R9 USB port for connecting to a computer WARNING Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards IEC 950 for data processing or...

Страница 15: ...rial number Bumper Feet Symbol Description Attention consult accompanying documents Date of manufacture CE Marked in accordance with the European Council Directive 93 42 EEC concerning medical devices...

Страница 16: ...t the probe tip for any signs of an occlusion and reposition the power switch to On If both green and yellow lamps are still illuminated and the probe is not occluded contact a local service represent...

Страница 17: ...paper should be stored as follows a Store in the dark i e in a drawer or cabinet b Do not store above 77 F 25 C c Store at less than 65 relative humidity The above recommendations are for the maximum...

Страница 18: ...14 Installation Welch Allyn TM286 Auto Tymp...

Страница 19: ...tips allow the user to place the probe and hold the Probe Tip at the entrance to the patient s ear canal while the tympanogram and reflex testing are performed P1 Yellow The probe is occluded Remove t...

Страница 20: ...r Advance Causes paper to feed through printer may be used to load paper or to provide space between printouts F4 PAGE Enters Page Mode Pressing F13 and F14 scrolls through the test results stored in...

Страница 21: ...o the next lower frequency selecting advances the presentation tone to the next higher frequency F15 Steady Used during Audiometry mode to select a continuous test tone when Present Bar is depressed t...

Страница 22: ...Probe Tone F28 Prog ram Selects Program mode screen which lists settings available for reflex presentation format printout header format audiogram vs tabular format display normal box and identify fre...

Страница 23: ...J Pressure Sweep Scale in daPa A Audiogram Display B Test Ear C Test Headset selected make certain the correct earphones are plugged in for this selection D Indicates Signal is being presented when di...

Страница 24: ...thout removing the probe The key to success in all cases is to be at eye level with the ear canal Use a steady hand monitor the ear canal and probe lights until the test is over It is a good idea upon...

Страница 25: ...to a steady glow and remain steady while the test is in progress 6 When the test sequence is over all lamps on the probe will turn off and the test result can be viewed on the instrument display befor...

Страница 26: ...f a good seal a Eliminate all obstruction between the earphones and the ears e g hair eyeglasses earrings hearing aids etc b Adjust the headband so that it rests solidly on the crown of the subject s...

Страница 27: ...robe is placed in the ear canal 3 Examine the ear canal to determine the appropriate size eartip for the test and position the eartip on the probe Be certain that the eartip is pushed as far down the...

Страница 28: ...the ear canal volume ECV the compliance peak in cm3 the pressure at the peak of the tympanogram in daPa and the gradient GR as a peak width value This test result can be printed out immediately as a...

Страница 29: ...ally as follows 226 Hz Probe Tone Temporary programming of ipsilateral acoustic reflex test frequencies The instrument defaults to a 1000 Hz Ipsilateral test stimulus when the Tymp Reflex button is fi...

Страница 30: ...utput jacks for the transducers two buttons allow separate calibration files to be accessed Be sure that the transducers that are connected to the back of the TM286 are the same as the selected transd...

Страница 31: ...ordingly Also the dB level displayed above the frequency value on the right hand side of the audiogram changes For each frequency there is a fixed intensity range available while rotating the dB HL kn...

Страница 32: ...esired screening intensity by rotating the dB HL knob to the appropriate position The American Speech Language and Hearing Association recommends 20 dB as the screening level for school age children S...

Страница 33: ...hed Note that the appropriate symbol 0 right X left appears at the correct intensity level where the threshold was determined 7 Repeat this test sequence for each frequency to be tested 8 When the thr...

Страница 34: ...y the second ear results When the second ear sequence is completed the entire audiogram containing thresholds for both ears are stored in memory The threshold series for any frequency will be consider...

Страница 35: ...h they were obtained The Page mode will be exited when you press the PRINT ALL or ERASE ALL buttons or any button that would normally begin the setup of a new test Page Mode is ready only No changes c...

Страница 36: ...32 Operation Welch Allyn TM286 Auto Tymp...

Страница 37: ...reen Toggles the option on or off An asterisk appears to the left of the item to denote the item has been selected Pressing again removes the asterisk which deselects the item Page Use this button to...

Страница 38: ...Reflex dB HL plus curve All reflex test results will appear on the display and printout with the following information a I Ipsilateral selected b Frequency 500 1000 2000 or 4000 Hz c Intensity level...

Страница 39: ...eflex dB HL only is selected the stimulus frequency stimulus routing and the dB HL level for the reflex will appear on the display and printout Figure 14 Display format for TYMP REFLEX Test Reflex tes...

Страница 40: ...sterisk is displayed beside the new default setting REFLEX This feature determines the stimuli and signal routing of the acoustic reflexes as default settings To select the frequencies move the cursor...

Страница 41: ...sting To change the Min dB lowest level place the cursor on that line and turn the HL knob on the front panel to the desired level Press the to move the cursor to the Max dB line and use the HL knob a...

Страница 42: ...range of frequencies includes 125 Hz through 8000 Hz The narrow range of frequencies includes 500 Hz through 6000 Hz In the AUD mode if the narrow range is selected the and Hz buttons will allow you...

Страница 43: ...R INSERT The External Headset Earphones are the factory default transducers To select the INSERT EARPHONES as the default start up option move the cursor next to the DEF XDUCER INSERT selection and pr...

Страница 44: ...ADER WA This is the factory default setting for this feature Each time the Print Screen or Print All tests in memory buttons are pressed the printout will begin with the label TM286 PRINT HEADER OFF I...

Страница 45: ...AL PRINTER EXTERNAL PRINTER These items toggle between either printing to the internal printer 4 paper or sending the information to an external printer The external printer is connected through a USB...

Страница 46: ...ymp Exiting the program mode Press the PROG button to exit the program mode and return to the previously selected test mode 4000 Hz 6000 Hz INTEN RANGE DBHL MIN DB 0 MAX DB 90 START TEST EAR RIGHT SCO...

Страница 47: ...ring this check as mechanical noise may be picked up by the probe and interfere with the calibration check The calibration check will start automatically if the probe has been inserted into the cavity...

Страница 48: ...s the Print All button on the front panel of the instrument Altitude adjustment The altitude calibration adjustment enables a correction to the ear canal volume ECV measurement and test cavity volume...

Страница 49: ...enter the custom calibration mode CUSTOM will appear on the fourth line of the display 6 The value now displayed in the cm3 display area is the volume measured and adjusted to the current altitude If...

Страница 50: ...apparent hearing loss at the low frequencies Also Audiocups are available from Welch Allyn as an optional accessory If the person being tested is in the same room as the audiometer it is recommended...

Страница 51: ...on within this range may be considered acceptable Variations that exceed this range however are likely to reveal problems that require attention The routine maintenance checks described in this chapte...

Страница 52: ...is clean and free of cerumen Refer to the following instructions for cleaning and maintaining the instrument s probe Probe nose cone cleaning Remove the nose cone portion of the probe 1 Hold the body...

Страница 53: ...on swab spread a thin layer of lubricant completely around the front and outer surface of the O Ring Ensure that no lubricant spreads into the threaded area of the nose cone Only a thin layer of lubri...

Страница 54: ...elect the right earphone and press the Present bar 3 While the Present bar is depressed flex the earphone cord next to the connector at both ends 4 Listen for an intermittent signal an abrupt change i...

Страница 55: ...measurement is to determine if there is a perforation of the tympanic membrane If there is a perforation due to trauma or due to the presence of a pressure equalization P E tube the measured ear canal...

Страница 56: ...chian tube The severity of this condition is determined by how negative the pressure is and its impact on the compliance peak If no pressure peak is measured over the pressure range of 200 daPa to 400...

Страница 57: ...d probe The presence of a reflex in the absence of a compliance peak suggests that the tympanometric results should be considered invalid and the test repeated This is true because if there is no comp...

Страница 58: ...error code appears please repeat the operation that caused the error code to appear If the error code appears for the second time make a note of it and contact a Welch Allyn service representative an...

Страница 59: ...Directions for Use Test Results 55 Figure 22 226 Hz Abnormal Tympanogram Figure 23 226 Hz Abnormal Tympanogram Figure 24 226 Hz Abnormal Tympanogram...

Страница 60: ...56 Test Results Welch Allyn TM286 Auto Tymp...

Страница 61: ...rule If the last most recent test result is displayed the instrument assumes normal testing operation and transfers all test results Other LCD screen messages INVALID SELECTION This message appears i...

Страница 62: ...elections fall into three groups Baud rate Parity and data bits Flow control The default setting for each group has an asterisk before it so that it is easy to scan the settings for each group Selecti...

Страница 63: ...f the computer The TM286 defaults to 115 kBaud no parity 8 data bits 2 stop bits and no communications flow control The default settings for the baud rate parity number of data bits and flow control m...

Страница 64: ...60 Computer Interface Welch Allyn TM286 Auto Tymp...

Страница 65: ...Manual Pure Tone Threshold Audiometry Protective Classification This system is intended for continuous operation and has a protective classification of Class 1 Class 1 Type B Probe Tone 226 Hz 2 Sound...

Страница 66: ...ympanogram width taken at 50 of peak compliance Frequencies 500 1000 2000 and 4000 Hz for ipsilateral stimulation Accuracy 3 Total Harmonic Distortion 5 for outputs less than 110 dB HL and 10 at 110 d...

Страница 67: ...and 6000 Hz measured electrically Audiometric Headset Pair External Headset earphones Type 51 cushions 10 ohms impedance Headband force per ANSI S3 6 and IEC 645 4 5 0 5 Insert Earphones Ear Tone Inse...

Страница 68: ...rams Reflex 1 Audiogram per person Speed Approximately 1 minute to print three screens Tympanogram Tympanogram reflex 4 Audiogram External Printer Optional Deskjet color printer recognizing PCL3 or PC...

Страница 69: ...ce Guide on CD part number 482 6387xx for EMC information concerning your system Dimensions 12 5 W x 14 5 D x 4 7 H 31 8 cm W x 36 8 cm D x 11 9 cm H Weight 5 lbs 2 3 kg unit and probe Dimensions 19 5...

Страница 70: ...ips 13 mm box of 25 26015 TM Eartips 15 mm box of 25 26017 TM Eartips 17 mm box of 25 26019 TM Eartips 19 mm box of 25 26100 TM Eartips 6 sizes 2 each 26240 TM Dust Cover 26241 TM Test Cavity 28203 DD...

Страница 71: ...Margolis R H Shanks J E Tympanometry In Katz J Ed Handbook of Clinical Audiology Ed 3 Baltimore Williams Wilkins 1985 Margolis R H Bass Ringdahl S Hands W Holte L and Zapala D A 2003 Tympanometry in N...

Страница 72: ...68 Standards Specifications and Accessories Welch Allyn TM286 Auto Tymp...

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