Hillrom Welch Allyn TM286 Instructions For Use Manual

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Welch Allyn® TM286

Auto Tymp

Instructions for use

Part Number 28603 Rev G

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Page 1 Welch Allyn® TM286 Auto Tymp Instructions for use Part Number 28603 Rev G...
Page 2 This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, contact Hillrom Technical Support: hillrom.com/en-us/about-us/locations...
Page 3: Table Of Contents
Instructions for use Introduction ..............1 Intended use.
Page 4 Welch Allyn® TM286 Auto Tymp Transducers ................61 Intensity Levels .
Page 5: Introduction
Intended use The Welch Allyn TM286 Auto Tymp is an audiometric screening product that offers basic pure tone audiometry and tympanometry with reflex. The TM286 Auto Tymp is available with both 226Hz and 1Khz probe tones to accommodate testing for patients between the ages of birth through geriatric.
Page 6: Supplied Accessories
Welch Allyn® TM286 Auto Tymp Supplied Accessories Check that all accessories itemized in Supplied Accessories below are received in good condition. If any accessories are missing, contact Welch Allyn immediately. See “Accessories” on page 63 and the listings below for the catalog numbers of accessories and also for a listing of optional accessories.
Page 7: Safety Summary
Instructions for use Safety Summary Before using the TM286 Auto Tymp, familiarize yourself with the sections of this instructions for use that pertain to your use of the TM286 Auto Tymp. • Failure to understand and observe any warning statement in this manual could lead to patient injury, illness, or death.
Page 8 Welch Allyn® TM286 Auto Tymp 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 9: Warranty
Instructions for use Customer Responsibility WARNING 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 product should not be used. Make sure all connections to external accessories are snug and secured properly.
Page 10 Welch Allyn® TM286 Auto Tymp pressure. While the recording is visualized in the horizontal direction (X-axis) as a function of differential pressure across the eardrum, the tracing also moves in the vertical direction (Y-axis) as a function of mobility or admittance of the middle ear system.
Page 11 Instructions for use transmitted via the 8th nerve to the brain stem where a determination is made as to whether or not the intensity of the stimulus is high enough to elicit a reflex response. If it is, a bilateral response occurs (i.e., the right and left 7th nerves innervate their respective middle-ear muscles (stapedial muscles) causing them to contract).
Page 12 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 HL) control the intensity with a hand switch. Compliance Peak The point of maximum mobility in a tympanogram, which indicates the degree of mobility within the middle-ear system.
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. Everyone who connects additional equipment to the signal input or signal output part configures a medical system, and is, therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult Welch Allyn at hillrom.com/en-us/about-us/locations...
Page 15: Bottom Panel
Instructions for use 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. Mandatory - Consult Instructions for Use Date of manufacture Manufacturer CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices.
Page 16 Welch Allyn® TM286 Auto Tymp Symbol Description Serial number. Prescription only or "For Use by or on the order of a licensed medical professional" China RoHs Stand-by Right Ear Left Ear Patient Response Button AC Power Printer Connector USB Type Connectors Computer Connector Initial set-up Place the instrument on a stable counter or table where it will be used.
Page 17 Instructions for use Allow the instrument to warm-up for about 10 minutes before conducting a test. This allows the electronic circuits to stabilize prior to use. If the storage temperature is lower than the room temperature, allow additional time for the instrument to reach room temperature. Caution Use only the provided power supply.
Page 18 Welch Allyn® TM286 Auto Tymp...
Page 19: Operation
Operation 226 Hz Probe Indicators Figure 1. Probe indicators P1 - Yellow: The probe is occluded. Remove the probe and inspect for cause of occlusion. P2 - Green lamp: Blinking - The instrument is ready to begin a Tymp. Steady green - Test successfully started and in progress.
Page 20: Front Panel Controls And Indicators
Welch Allyn® TM286 Auto Tymp Front Panel Controls and Indicators Figure 2. Front panel F2 F2 F14F15 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 Instructions for use 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 Welch Allyn® TM286 Auto Tymp Legend / Label Button Description F22 / TYMP Selects Tympanometry only mode. 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. F26 / IPSILATERAL Selects an ipsilateral reflex test.
Page 23 Instructions for use Figure 4. 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 5.
Page 24 Welch Allyn® TM286 Auto Tymp Patient Response Switch (optional accessory) is being pressed M indicates manual testing A indicates automatic testing Tympanometry testing information It is good practice to perform a test on a normal ear each day to make certain that the instrument is functioning properly.
Page 25 Instructions for use Figure 6. Positioning the eartip 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. Keep the pinna in this position throughout the test sequence.
Page 26 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 Instructions for use Insert the eartip well into the ear canal. Interauaral attenuation is improved with deep insertion. Allow foam to expand to acoustically seal ear canal. Discard foam eartips after a single use. Note If using insert phones, ensure the appropriately sized foam tip is selected. Response handswitch (optional accessory) If the optional handswitch is used, make sure that the handswitch connector is properly inserted into the jack on the rear panel.
Page 28 Welch Allyn® TM286 Auto Tymp The automatic stop when the tympanogram compliance returns to baseline eliminates unnecessary pressurization of the ear and shortens the test time. When the tympanogram is completed and the test is finished, the steady green lamp turns off and the test results are displayed.
Page 29 Instructions for use The intensity levels available vary with the frequency selected ipsilaterally as follows 226 Hz Probe Tone IPSILATERAL Intensity Levels 500 Hz 80, 90, 100 dB HL 1000 Hz 85, 95, 105 dB HL 2000 Hz 85, 95, 105 dB HL 4000 Hz 80, 90, 100 dB HL Note Although four frequencies are available during the tymp and ipsilateral reflex...
Page 30 Welch Allyn® TM286 Auto Tymp Audiometry Test Sequence To enter the Audiometry mode Press the AUD button. Note that the display changes from a Tympanogram or Tymp/Reflex format to an audiogram format. Transducer Selection Select the transducer to be used for the Audiometric testing. Press to select headphones or to select insert phones.
Page 31 Instructions for use 500 to 4000 Hz -10 to 90 dB HL 6000 Hz -10 to 85 dB HL 8000 Hz -10 to 70 dB HL The cursor on the audiogram moves up and down accordingly. Also, the dB level displayed above the frequency value on the right-hand side of the audiogram changes.
Page 32 Welch Allyn® TM286 Auto Tymp If the individual fails to respond, increase the intensity by 10 dB and try again. Press the button at the intensity level where the individual responded. 10. Continue the procedure for all the desired frequencies. Audiometric Threshold The TM286 provides two ways to perform Audiometric Threshold testing.
Page 33 Instructions for use Theory of Operation The following points describe the stimulus presentation patterns and patient response validity: The stimulus on-time is fixed at 1.5 seconds. The Inter-stimulus interval is randomized between 3 and 5 seconds. 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.
Page 34 Welch Allyn® TM286 Auto Tymp Tests in memory The Tymp and Tymp Reflex test results are automatically stored in memory when the test sequence ends. Audiometric test results are stored in memory when is pressed. A total of 12 memory pages are available with the TM286.
Page 35: 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 36: Program Menu Page 1 Option Descriptions
Welch Allyn® TM286 Auto Tymp Note Pushing the Print button while in Program mode will print out the currently programmed settings. Note 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...
Page 37 Instructions for use Frequency: 500, 1000, 2000, or 4000 Hz Intensity level where response was detected d. Tracing of actual response curve Figure 1. 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 2.
Page 38 Welch Allyn® TM286 Auto Tymp Figure 3. 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” will appear next to the frequency.
Page 39 Instructions for use Intensity Range (dB HL) . . . Start test ear . . . 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 40 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. Scoring Rule *2 out of 3 Return to Auto HL Set up...
Page 41 Instructions for use DEF XDUCER EXTERNAL HEADSET EARPHONES / DEF XDUCER 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 press to save.
Page 42: Program Menu Page 2 Option Descriptions
Welch Allyn® TM286 Auto Tymp Program Menu Page 2 Option Descriptions DATA XFER CONFIG * 115.2 KBAUD * NO PARITY + 8-BIT 57.6 KBAUD ODD PARITY + 7-BIT 38.4 KBAUD EVN PARITY + 7-BIT 17.2 SPC PARITY + 7-BIT 9600 BAUD * XON/XOFF DISABLED 4800 BAUD XON/XOFF ENABLED...
Page 43 Instructions for use custom header is complete, press the PROG button to exit from the submenu. To change/delete a previously saved character, press the to position the cursor at that character. Use the HL knob to select the new character to change or select the blank space to delete. Note To center the header, consider the length of the name to be inserted and calculate from the left margin where the header will begin.
Page 44 Welch Allyn® TM286 Auto Tymp 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 45: Routine Maintenance
Routine Maintenance PreTest Tymp checks 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 46 Welch Allyn® TM286 Auto Tymp Since sound pressure will vary with altitude and barometric pressure, some variation from the 0.5, 2.0 and 5.0 cm readings may be observed. The instrument is carefully calibrated at our factory, which is at approximately 850 feet above sea level.
Page 47 Instructions for use Altitude Mode ECV 2.0 9.99 Standard Select 226 Hz probe tone. Place the probe into the 2.0 cm cavity provided with the instrument and check the cm value against the altitude correction table for accuracy. If the measured volume is not within the published table value ±/.1 cm , then exit the altitude mode by pressing the PROGRAM MODE button and contact field service.
Page 48 Welch Allyn® TM286 Auto Tymp Maximum permissible noise levels are specified by the American National Standards - Criteria for Permissible Background Noise during Audiometric Testing, ears covered with earphones (S3.1 1991 revised). The table below, “Maximum Permissible Background Noise Levels” shows the maximum background levels that can be present inside the room while a valid hearing test is being conducted.
Page 49 Instructions for use Preventive Maintenance Preventive maintenance does not require access to the interior of the instrument and may be performed by the operator. For the TM286, preventive maintenance consists of periodically cleaning and inspecting the exterior of the instrument. We also recommend cleaning and inspecting the accessories such as the probe and/or earphones. It is recommended a routine schedule is implemented for these purposes.
Page 50 Welch Allyn® TM286 Auto Tymp Place the probe body securely on a table and inspect the nose cone for cerumen. Use floss cleaning thread to remove any cerumen by inserting the floss cleaning thread through the back portion of the nose cone and pulling it through the front opening.
Page 51 Instructions for use Carefully remove this wire from the metal tube (See “Probe wire removal” below). This will pull any cerumen out of the metal tube. Figure 4. Probe wire removal Examine the wire for cerumen. If necessary, clean the wire with a lint-free tissue. Reinsert the wire into the metal tube and push it in as far as it can go.
Page 52 Note 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 62 of this guide for approximations). Replacement paper can be purchased from Welch Allyn at hillrom.com/en-us/about-us/locations...
Page 53: 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 54: Pressure Peak
Welch Allyn® TM286 Auto Tymp A compliance value greater than 1.4 cm (or 1.8 cm ) indicates a hyperflaccid tympanic membrane or a possible disarticulation depending upon how far above the normal range the value is. Generally speaking, a compliance value of greater than 3.0 cm is indicative of a disarticulated ossicular chain.
Page 55: Acoustic Reflex
Instructions for use Acoustic reflex Normal For screening purposes, an ipsilateral reflex measured at any one of the levels available per frequency can be considered normal. Obviously, the lowest values are desired. However, without knowing the hearing threshold level of the individual per frequency, it is difficult to make a more definite statement. Generally speaking, the reflex is reported to occur at between 70 and 90 dB HL above the hearing threshold in patients with normal hearing.
Page 56: Sample Test Results
Welch Allyn® TM286 Auto Tymp Sample Test Results The following figures illustrate test results from sample TM286 Auto Tymp printouts. The smoothness of the tympanogram tracing is determined by the amount of movement during the testing. Little or no movement during the testing provides a smoother tracing.
Page 57 Instructions for use Figure 4. 226 Hz Abnormal Tympanogram Figure 5. 226 Hz Abnormal Tympanogram...
Page 58 Welch Allyn® TM286 Auto Tymp...
Page 59: 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 60 Welch Allyn® TM286 Auto Tymp NO DATA AVAILABLE This message appears if the button is pressed and no results are stored. NOT AVAILABLE This message appears if the button is pressed and the computer is not properly connected. 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.
Page 61 Instructions for use Computer Interface Interface configuration 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.
Page 62 Welch Allyn® TM286 Auto Tymp...
Page 63: 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) IEC 60645-1 Pure Tone Audiometers (Type 4) GL2005-00014 (ASHA 2005) Guidelines for Manual Pure-Tone...
Page 64: Pneumatic System
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 65: Probe Led Indicators
Instructions for use 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 66: Tone Format
Welch Allyn® TM286 Auto Tymp Signal-to-Noise Ratio: > 70 dB in 1/3 octave; less than -10 dB HL for levels less than 60 dB HL Rise/Fall Time: 20 to 50 msec Tone Format Tone is normally off until the Present bar is depressed Continuous Tone is steady when present bar is depressed Pulsed...
Page 67: Mechanical
Instructions for use 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" W x 22.5" D x 8.25" H 49.5 cm W x 57.2 cm D x 20.9 cm H Weight 13.1 lbs (6 kg)
Page 68: Electromagnetic Compatibility
Welch Allyn® TM286 Auto Tymp Welch Allyn Part Number Welch Allyn Description 28601 TM286 power brick (for devices with serial numbers GS0077116 and earlier) 729243 Power supply AM282, TM 286, 4th Edition (for devices with serial numbers GS0077117 and later) 28602 TM286 Cord, Power, Hosp Gade 28603...
Page 69 The Welch Allyn TM286 Auto Tymp is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn TM286 Auto Tymp should assure that it is used in such an environment. Guidance and manufacturer’s declaration—electromagnetic emissions The Welch Allyn TM286 Auto Tymp is intended for use in the electromagnetic environment specified below.
Page 70 RF communications equipment The Welch Allyn TM286 Auto Tymp is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Welch Allyn TM286 Auto Tymp can help prevent...
Page 71 The Welch Allyn TM286 Auto Tymp is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn TM286 Auto Tymp should assure that it is used in such an environment. Guidance and manufacturer’s declaration—electromagnetic immunity The Welch Allyn TM286 Auto Tymp is intended for use in the electromagnetic environment specified below.
Page 72 Welch Allyn® TM286 Auto Tymp Immunity test IEC 60601 test Compliance Electromagnetic environment—guidance level level Portable and mobile RF communications equipment should be used no closer to any parts of the Welch Allyn TM286 Auto Tymp, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Page 73 Instructions for use Item Manufacturer Part number Complete headset with DD45 Earphones and RadioEar 28203 headband Audiometry Patient Response Switch Grason-Stadler 23220 Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below: Description Length...
Page 74: Bibliography
Welch Allyn® TM286 Auto Tymp 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".