Welch Allyn TM286 Directions For Use Manual
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Welch Allyn TM286 Directions For Use Manual

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Welch Allyn TM286
Auto Tymp
Directions for use
Part Number 28603 Rev D

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Summary of Contents for Welch Allyn TM286

  • Page 1 Welch Allyn TM286 Auto Tymp Directions for use Part Number 28603 Rev D...
  • Page 2 Welch Allyn TM286 Auto Tymp ©2011 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.

  • Page 3: Table Of Contents

    Directions for use 1 - Introduction........... 1 Unpacking and inspection.
  • Page 4 Welch Allyn TM286 Auto Tymp Intensity Levels............63 Tone Format .

  • Page 5: Introduction

    As soon as the carrier has completed the inspection, notify a Welch Allyn representative. If the instrument must be returned, repack it carefully (in the original TM286 Auto Tymp container if possible) and return it prepaid to Welch Allyn for necessary adjustments.

  • Page 6: Optional Accessories

    Follow all of your respective local laws and regulations for the proper disposal of batteries and any other parts of your system. Safety Summary Before using the TM286 Auto Tymp, familiarize yourself with the sections of this directions for use that pertain to your use of the TM286 Auto Tymp. •...
  • Page 7 Safety Notes WARNING The TM286 is designed to be used with a hospital grade outlet. Injury to personnel or damage to equipment can result when a three-prong to two-prong adapter to is connected between the TM286 power plug and an AC outlet or extension cord.

  • Page 8: Warranty

    Should the user suspect fluids have contacted the system components or accessories, the unit should not be used until deemed safe by a Welch Allyn certified service technician. WARNING Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases.
  • Page 9 Directions for Use Introduction Acoustic energy, commonly referred to as the probe tone (226 Hz) is introduced into a hermetically sealed ear canal by means of a loudspeaker located within the probe. The intensity of this tone is monitored via a microphone, also located within the probe box. Measurements are taken at fixed time intervals.
  • Page 10 Under this condition, no gradient measurement is possible. On the TM286, gradient measures are calculated for the 226 Hz probe tone conditions. Screening acoustic reflex An acoustic reflex occurs when a very loud sound (stimulus) is presented to the auditory pathway.
  • Page 11 The individual being tested must be able to understand a set of simple instructions and have the ability to provide some physical sign when the test signal is heard. The TM286 allows for both manual and automated audiometry. For further details on automated audiometry, see “Automatic Hearing Level”...
  • Page 12 Introduction Welch Allyn TM286 Auto Tymp Glossary of terms Acoustic Reflex Reflexive contraction of the stapedius muscle in response to loud sound. Automated Automated measurement of hearing that allows the listener to Audiometry (Auto control the intensity with a hand switch.

  • Page 13: Installation

    Installation Printer and Display Figure 1. TM286 major component identifications Paper cover Probe holder Printer Probe cable connector Probe Figure 2. Probe...

  • Page 14: Rear Panel Labels And Connectors

    IEC 60601-1-1. If in doubt, consult Welch Allyn at Tel.: 1-800- 535-6663 (In U.S.A. only) or Tel.:1-800-561-8797 (in Canada only).

  • Page 15: Bottom Panel

    Figure 4. Bottom panel Prop feet CE Label and serial number Bumper Feet Symbols on the TM286 Auto Tymp Symbol Description Attention, consult accompanying documents. Date of manufacture CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices Special Recycling Required.
  • Page 16 On. If both green and yellow lamps are still illuminated and the probe is not occluded, contact a local service representative or the Welch Allyn service department for repair. In the mean time, it is still possible to use the Audiometry mode (if purchased).
  • Page 17 Directions for Use Installation Figure 5. Paper loading Paper Well Paper Slot Position the leading edge of the paper roll into the paper slot. Press the paper advance button until a section of paper is long enough to pass through the printer cover. Paper storage The instrument is supplied with a thermal printer.
  • Page 18 Installation Welch Allyn TM286 Auto Tymp...

  • Page 19: Operation

    White Flat ear 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. WARNING A Welch Allyn provided Probe Tip must be used. Using the probe without the Probe Tip could result in injury to the subject.

  • Page 20: Front Panel Controls And Indicators

    Operation Welch Allyn TM286 Auto Tymp Front Panel Controls and Indicators Figure 7. Front panel F24 F25 F14 F15 F18 F16 F19 Legend / Label Button Description F1 / Print Screen Used to print the currently displayed page of memory or active test screen.
  • Page 21 Directions for Use Operation Legend / Label Button Description F8 / M+ Save button; during Audiometry mode, saves threshold information per frequency on the display; during Program mode, selects highlighted option. F9 / +10 dB +10dB Used to temporarily extend the intensity range by 10 dB; a large + sign appears on the display indicating that the extended range has been selected.
  • Page 22 Operation Welch Allyn TM286 Auto Tymp Legend / Label Button Description F23 / Tymp Reflex Selects Tympanometry and Reflex mode. F24 / 226Hz Selects 226 Hz for Probe Tone Frequency. F25 / 1KHz Not available with the 226 Hz Probe Tone.
  • Page 23 Directions for Use Operation Figure 9. 226 Hz Tympanometry/Reflex screen ASHA Box Scale of Tympanogram Compliance Test Ear Reflex Stimulation Routing (IPSILATERAL) Frequency of Reflex Stimulus Ear Canal Volume Peak Amplitude Pressure at peak Gradient/Tympanogram Width Pressure Sweep Scale in daPa Figure 10.
  • Page 24 Obtaining a seal WARNING A Welch Allyn provided Probe Tip must be used. Using the probe without the Probe Tip could result in injury to the subject.
  • Page 25 Directions for Use Operation Figure 11. Positioning the eartip 2. Move any hair away from the ear and pull up and back on the pinna (pull downward and back on the pinna of a young child.) This will straighten out the ear canal and enable better results.
  • Page 26 Operation Welch Allyn TM286 Auto Tymp Audiometry testing Prior to testing, ensure that the earphone cords are plugged into the appropriate connectors on the rear panel of the instrument. Both Headphones and Insert phones are available. Select the appropriate transducer and the desired tone type (i.e., pulsed, steady, or FM).
  • Page 27 Directions for Use Operation 3. Place the black tubing of an ER-3A foam eartip (optional accessory) completely onto the connector of the sound tube. 4. Roll the foam tip into the smallest diameter possible. 5. Insert the eartip well into the ear canal. Interauaral attenuation is improved with deep insertion.
  • Page 28 Operation Welch Allyn TM286 Auto Tymp The pressure sweep begins at the starting pressure of +200 daPa and proceeds in the negative direction at a rate of 600 daPa/second. Measurements of compliance are made continuously as the pressure sweep continues in the negative direction. The slope of the tympanogram increases as the measurement approaches the compliance peak.
  • Page 29 Directions for Use Operation default setting established in the Program mode determines the manner in which the reflex result is displayed. See “Program Mode” on page 33. 4. If no response is measured (i.e., for 226 Hz probe tone, a compliance change of at least 0.05 cm was not detected) at the lowest intensity level, the intensity level of the stimulus is automatically increased by 10 dB.
  • Page 30 Be sure that the transducers that are connected to the back of the TM286 are the same as the selected transducer from the front panel. If Headphones are selected, a will appear in the center of the LCD.
  • Page 31 Directions for Use Operation audiometry mode defaults to 1000 Hz at 0 dB HL, the cursor is positioned at the corresponding location on the audiogram. Please note that even though tabular format may be selected for the audiometric test results on the printout, the LCD display is always in the audiogram format. To change the frequency Press the Hz button.
  • Page 32 10. Continue the procedure for all the desired frequencies. Audiometric Threshold The TM286 provides two ways to perform Audiometric Threshold testing. The system can be used in a Manual mode or an Automatic Hearing Level mode (Auto HL mode). In the Manual mode, the intensity, frequency and presentation of the stimulus are controlled by the tester.
  • Page 33 10 dB each time the patient presses the button and increased by 5 dB when the button is not pressed. The TM286 will present the stimulus and increase or decrease the intensity of the stimulus based on the patient response. The TM286 response/no response stimuli and determines the hearing threshold based on the data.
  • Page 34 Operation Welch Allyn TM286 Auto Tymp 3. When a valid response occurs, the intensity for the next stimulus presentation is decreased 10 dB. When no valid response occurs, the intensity of the next stimulus presentation is increased 5 dB. This is based on the Hughson-Westlake down 10, up 5 dB rule used by most audiologists during threshold testing.
  • Page 35 Printing test results The printout will begin with a header, if it is selected, in the program mode (i.e., TM286 or a custom header). The next two lines contain space for recording the individuals name and the test date. This is followed by the test results in the order they were obtained/ selected.
  • Page 36 Operation Welch Allyn TM286 Auto Tymp...

  • Page 37: Program Mode

    Program Mode To enter the program mode, press the Program (PROG) button located on the front panel. There are two screens for the Program mode. To move to the second page, press the Increase Frequency button or turn the Attenuator knob until the cursor is next to the arrow on the bottom right column.

  • Page 38: Program Menu Page 1 Option Descriptions

    Pushing the Print button while in Program mode will print out the currently programmed settings. When navigating through the Program menu, features that are not available on the purchased version of the TM286 will be represented by invalid on the LCD. Factory Default settings are listed on page Program Menu Page 1 Option Descriptions TYMP OPTIONS .
  • Page 39 Directions for Use Program Mode d. Tracing of actual response curve Figure 13. Display format for TYMP/REFLEX Test (Reflex test results with dB HL value and tracing) • Reflex dB HL only If Reflex 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.
  • Page 40 Program Mode Welch Allyn TM286 Auto Tymp Figure 15. Display format for TYMP/REFLEX Test (Reflex test results given as Yes or No) When the reflex test cannot be performed, due to a leak or early extraction of the probe, a “NT”...
  • Page 41 Directions for Use Program Mode Scoring rule . . . Tone Format . . . Place the cursor next to the line item, press the button to enter the submenu item. Auto HL features are selected in the Program mode by placing the cursor next to the parameter and pressing the button to engage the selection.
  • Page 42 Program Mode Welch Allyn TM286 Auto Tymp Scoring Rule: This submenu defines the number of valid responses required to determine threshold. To change the Scoring Rule, move the cursor next to the desired Scoring Rule and press the button. An asterisk denotes the selected Scoring Rule.
  • Page 43 Directions for Use Program Mode lines of test data. The test results for the right ear will appear next to the letter R and below each frequency tested. The test results from the left ear will follow below the right ear results.

  • Page 44: Program Menu Page 2 Option Descriptions

    * XON/XOFF DISABLED 4800 BAUD XON/XOFF ENABLED These settings are used to allow the data transfer from the TM286 to a computer. The settings must be the same on the TM286 and the computer. The factory defaults are defined by an *.
  • Page 45 To select the printer, move the cursor next to the Internal or External printer and press the button to save the setting. RESET TO DEFAULTS This option will reset the programmable settings to the Welch Allyn factory defaults. Program Mode - Factory Default Settings AUDIOMETRY RESULTS...
  • Page 46 Program Mode Welch Allyn TM286 Auto Tymp - 4000 Hz - 6000 Hz INTEN RANGE (DBHL) MIN DB MAX DB - 90 START TEST EAR - RIGHT SCORING RULE - 2 OUT OF 3 TONE FORMAT -STEADY Exiting the program mode Press the PROG button to exit the program mode and return to the previously selected test mode.

  • Page 47: Routine Maintenance

    A test cavity is provided with this instrument. This test cavity enables the ability to quickly verify, on a daily basis, the proper calibration of the unit. Welch Allyn strongly recommends that this quick check is a part of the daily routine.
  • Page 48 These changes in pressure do not affect the accuracy of the compliance measurement system in any way. However, it will affect the ECV values. The altitude calibration mode allows adjustment of the Auto Tymp without the services of a qualified Welch Allyn representative.
  • Page 49 Back to Normal and press the PAGE button to return to the Normal mode. CAL MODES and DIAG MODES can only be accessed by Welch Allyn trained Note individuals. If these items are selected, "Invalid Selection" will flash on the bottom right to indicate they are currently disabled.
  • Page 50 (i.e., sufficient to cause 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 that he/she be seated about three feet (1 meter) away from the instrument.
  • Page 51 The routine maintenance checks described in this chapter, may suggest the source and solution to the problem. If they do not, the instrument should receive technical service by a Welch Allyn certified technician before further use.
  • Page 52 WARNING It is recommended that all repairs be performed by a qualified Welch Allyn service representative only. Malfunctions resulting from improper maintenance or repair by anyone other than an authorized Welch Allyn representative will be the responsibility of the user.
  • Page 53 Directions for Use Routine Maintenance The O-Ring There is an O-Ring seated at the end of the threads on the probe. As a preventative maintenance measure, and to ensure that the nose cone of the probe unscrews easily, do not clean or remove the lubricant from the O-Ring. If the O-Ring appears to be void of any lubricant, or if the nose cone itself was difficult to remove, apply a high-quality synthetic lubricant such as those considered "food-grade."...
  • Page 54 The number of tests per roll of paper will vary with the version Auto Tymp being used and the type of tests being performed. (See page 64 of this guide for approximations). Replacement paper can be purchased from Welch Allyn at Tel.: 1-800-535-6663 (In U.S.A. only) or Tel.:1-800-561-8797 (in Canada only).

  • Page 55: Test Results

    Test Results Ear Canal Volume - Tympanometry Normal As a general rule, values for ear canal volume should be between 0.2 and 2.0 cm However, the normal values will vary with age and bone structure. Abnormal An ear canal value of less than 0.2 cm indicates an abnormal condition.

  • Page 56: Pressure Peak

    Test Results Welch Allyn TM286 Auto Tymp middle-ear system is consistent with a poorly functioning eustachian tube with possible effusion (serous otitis media) or "glue ear." If the measured compliance value is less than 0.1 cm , the letters NP will be...

  • Page 57: Acoustic Reflex

    Directions for Use Test Results gradient values may also be found in the absence of abnormal parameters. This could indicate a transient OME, so a retest after several weeks may be recommended. When the middle ear's mobility is reduced to near 0 cm3, due to viscous effusion or a "glue-ear"...

  • Page 58: Sample Test Results

    If the error code appears for the second time, make a note of it and contact a Welch Allyn service representative, and give him/her the exact error code number.
  • Page 59 Directions for Use Test Results Figure 22. 226 Hz Abnormal Tympanogram Figure 23. 226 Hz Abnormal Tympanogram Figure 24. 226 Hz Abnormal Tympanogram...
  • Page 60 Test Results Welch Allyn TM286 Auto Tymp...

  • Page 61: Computer Interface

    Computer Interface Introduction The Computer Interface provides the capability of transferring stored test results from the instrument to an external computer or data collection device via a USB connection. WARNING Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (IEC 950 for data processing or IEC 60601-1 for medical equipment).
  • Page 62 Data Transfer Program Mode The Data Transfer Program mode is used to modify the TM286 USB interface configuration parameters to match the computer's USB Port settings. Enter the Program mode by selecting the Program (PROG) button. Move the cursor to Data Xfer Config and press the button to enter the submenu.
  • Page 63 The configuration of the TM286 computer interface must be set to match the interface configuration of 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 may be modified using the Data Transfer Program Mode explained earlier in this chapter.
  • Page 64 Computer Interface Welch Allyn TM286 Auto Tymp...

  • Page 65: Standards, Specifications, And Accessories

    Standards, Specifications, and Accessories Standards and Compliance The TM286 meets 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)

  • Page 66: Pneumatic System

    Standards, Specifications, and Accessories Welch Allyn TM286 Auto Tymp Pneumatic System Pressure Range: +200 to -400 daPa Notes: 1. 1 daPa = 1.02 mm H 2. The pressure sweeps to at least -100 daPa. To save test time, pressure sweep stops when tympanogram returns to baseline after -100 daPa.

  • Page 67: Probe Led Indicators

    Directions for Use Standards, Specifications, and Accessories Probe LED Indicators Probe: Steady yellow: Occlusion Blinking green: Ready to start Steady green: Test in progress Steady orange: Leak in pressure No Light: Test is finished Audiometry mode Frequencies: 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz Accuracy: ±2% Total Harmonic Distortion:...

  • Page 68: Tone Format

    Standards, Specifications, and Accessories Welch Allyn TM286 Auto Tymp Tone Format Tone is normally off until the Present bar is depressed Continuous Tone is steady when present bar is depressed Pulsed Tone is pulsed at 2.5/sec (i.e., 200 msec ON, 200 msec OFF) FM (frequency modulated) Tone is frequency modulated at a rate of 5 Hz, ±5%...

  • Page 69: Mechanical

    Directions for Use Standards, Specifications, and Accessories Mechanical Instrument 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 Shipping Carton Dimensions: 19.5"...

  • Page 70: Accessories

    Threshold Audiometry Card 28601 TM286 Power Brick 28602 TM286 Cord, Power, Hosp Gade 28603 TM286 Directions for Use Manual (printed, English only) 28604 TM286 Quick Reference Guide 28605 TM286 Directions for Use Manual (printed, French only) 28607 TM Wall Chart for Tymp tracings 52600 TM Printer Paper, 4”...

  • Page 71: Bibliography

    Directions for Use Standards, Specifications, and Accessories Bibliography American Speech-Language-Hearing Association (1990). "Guidelines for Screening for Hearing Impairment and Middle Ear Disorders". ASHA, 32 (Suppl.2), 17-24. Criteria for Permissible Ambient Noise During Audiometric Testing (ANSI S3.1 - 1977) de Jonge, R.R. (1986). "Normal Tympanometric Gradient: A Comparison of Three Methods". Audiology, 26, 299-308.
  • Page 72 Standards, Specifications, and Accessories Welch Allyn TM286 Auto Tymp...

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