Welch Allyn MicroTymp 3 Directions For Use Manual
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Welch Allyn MicroTymp 3 Directions For Use Manual

Portable tympanometric instrument
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  • Page 1 MicroTymp ® portable tympanometric instrument Directions for use...
  • Page 2 Welch Allyn MicroTymp3 portable tympanometric instrument © 2009 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, precautions, warnings, or statement of intended use published in this manual.

  • Page 3: Table Of Contents

    Contents 1 - Introduction ..........7 About this document .
  • Page 4 Contents Welch Allyn MicroTymp3 portable tympanometric instrument Normative values ..........32 Interpreting 226-Hz tympanogram results .
  • Page 5 Directions for use Contents C - Specifications ......... . 63 Physical characteristics .
  • Page 6 Contents Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 7: Introduction

    Introduction About this document This document is written for clinical professionals who are qualified to perform tympanometry. The intended clinical environment is any location where tympanometry is performed (including but not limited to hospitals, clinics, medical offices, and schools). This document describes how to operate and maintain the MicroTymp Handle and Printer/ Charger.

  • Page 8: Controls, Indicators, And Connectors

    Introduction Welch Allyn MicroTymp3 portable tympanometric instrument Controls, indicators, and connectors Handle components Side view Front view Liquid Crystal Display (LCD) -400 -200 PRESSURE - daPa Left memory button TEST Probe Test button Right memory button ejector Battery cover 0297...

  • Page 9: Printer/Charger Components

    Directions for use Introduction Printer/Charger components CHARGE FEED button indicator PRINT button POWER Tip box indicator Charging well for MicroTymp 2 or 3 IEC power cord receptacle Printer/Charger switches Card holder with 1000-Hz screening results cards Paper access Paper cover slot Power Cord To power...

  • Page 10: Symbols

    Introduction Welch Allyn MicroTymp3 portable tympanometric instrument Symbols Documentation symbols Warning Caution (Warnings indicate conditions or practices (Cautions indicate conditions or practices that could lead to illness, injury, or death.) that could damage the equipment or other property) Consult instructions for use...
  • Page 11 Directions for use Introduction Certification symbols Meets essential requirements of European Complies with applicable U.S. and Medical Device Directive 93/42/EEC Canadian medical safety standards 0297 74227 Class I equipment, Type BF European regulatory manager (Handle) Class I equipment, Type B (Printer/Charger) Miscellaneous symbols Reorder number...

  • Page 12: General Warnings

    WARNING Explosion risk. Do not use MicroTymp Handle or Printer/Charger near flammable anesthetics. WARNING Electric shock hazard. Do not attempt to disassemble the Printer/ Charger. Refer all servicing to Welch Allyn or a Welch Allyn authorized service representative. WARNING Electric shock hazard. Use the USB connector only to connect to devices complying with IEC 60601-1 or other IEC standards as appropriate to the device.

  • Page 13: General Notes

    MicroTymp3 Handle. However, the original MicroTymp Printer/Charger (#7113x) will neither charge nor print data from the MicroTymp3 Handle. Please complete and return the warranty registration. It validates the warranty and allows Welch Allyn to communicate calibration notices and software changes. Initial setup Set up the printer/charger Place the Printer/Charger on a flat, horizontal surface.
  • Page 14 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument 2. Remove the battery cover by lifting the bottom of the cover away from the probe tip. 3. Insert the battery by placing the positive (+) end of the battery against the contact in the holder.

  • Page 15: Charge The Handle

    Directions for use Introduction Charge the handle Before first use, place the Handle (with battery installed) into the Printer/Charger charging well with the LCD and buttons facing you. 2. Leave the Handle in the well for a minimum of 16 hours to achieve a full charge. You are now ready to take a test.
  • Page 16 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 17: Completing A Test

    Probe Tip ejector 2. Push the tip onto the probe, making sure that the tip is fully seated. Start a test Pick up the handle and press any button. The Welch Allyn screen will display. -400 -200 PRESSURE - daPa...
  • Page 18 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument Time-out feature. The tympanometer automatically turns off 15 seconds after the Note last test or button activation. TEST 2. Press the button below the Liquid Crystal Display (LCD) to show the current frequency.
  • Page 19 Directions for use Completing a test Note Because of changes in air pressure during a test, the subject will feel slight pressure in the ear canal. During the brief seconds when tympanometric measurements are made, it is important that the clinician's hand is steady, and that the subject does not talk, yawn, chew gum, cry, or move the head.

  • Page 20: Store And Display Data

    Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument Store and display data To store the results of the test, press the button which matches the tested ear, as illustrated below. The memory buttons are labeled for the right ear and for the left ear.
  • Page 21 Directions for use Completing a test 3. Remove the Handle cover by lifting the bottom of the cover away from the probe tip. Lithium 72910 4. With a sharp, non-conductive object (like a toothpick or the wooden end of a Q-tip), move switch 1 to the desired position as shown below.
  • Page 22 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 23: Understanding The Lcd Messages

    Understanding the LCD messages The following messages may be displayed on the LCD during Handle operation. Company identification -400 -200 PRESSURE - daPa The Welch Allyn message will appear when you press any button. Frequency confirmation -400 -200 -400 -200...

  • Page 24: Open

    Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument Open -400 -200 -400 -200 PRESSURE - daPa PRESSURE - daPa The test has not begun since a valid ear cavity has not been detected. Possible causes: • Instrument is not in an ear •...

  • Page 25: Block

    Directions for use Understanding the LCD messages Block The test cannot continue since the measured admittance is less than 0.2 mmho. Possible causes: • Probe tip is lodged against canal wall • Ear canal occluded • Collapsed ear canal • Extremely small ear •...

  • Page 26: Right Store/Left Store

    Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument Possible solutions: • Reposition probe tip • Patient and practitioner must remain still • Use a different size probe tip • Increase pressure against the ear If a leak condition occurs after -100 daPa pressure is reached at 226 Hz, results will remain on the display.

  • Page 27: Low Battery

    Directions for use Understanding the LCD messages Low battery -400 -200 PRESSURE - daPa The LOW BATT message indicates that the battery needs to be recharged. The system will not perform a test in a LOW BATT condition. All buttons are disabled to prevent inaccurate results due to inadequate battery voltage.

  • Page 28: Calibration Due

    The NEEDS SVC message appears when something has caused the tympanometer to fail an internal test. The NEEDS SVC message will display for approximately three seconds; then the device will power down. Return the tympanometer to a Welch Allyn service location for service. (See Service information.) After each service, the device must be calibrated.

  • Page 29: System Check

    Press any button to power the Handle and clear the condition. If these messages persist, the Handle requires service. Return the tympanometer to a Welch Allyn service location for service. (See Service information.) Note After each service, the device must be calibrated. Appropriate charges will apply each time your tympanometer is calibrated.
  • Page 30 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 31: Interpreting Test Results

    Interpreting test results When measured properly, tympanometric results are accurate and objective but should be interpreted in the context of the patient’s overall clinical condition. Tympanograms Key characteristics of the tympanogram Static Admittance (Peak Ya) is a calculated measure of the compensated static acoustic admittance (height) of the tympanometric peak reported in acoustic s (mmho).

  • Page 32: Gradient (Width) Measurements (226 Hz Only)

    Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument Gradient (width) measurements (226 Hz only) When a tympanometric tracing is complete, the device measures the gradient or width of the tympanogram. If the gradient is abnormal, an asterisk will appear on the LCD under GR/A for the adult's ear (greater than 10 years of age), or GR/C for the child's ear (10 years of age or younger).

  • Page 33: Interpreting 226-Hz Tympanogram Results

    Directions for use Interpreting test results Interpreting 226-Hz tympanogram results Normal middle ear A tympanogram with normal Peak Ya, gradient (width), and tympanometric peak pressure appears below. RIGHT EAR +200 -400 -200 PRESSURE - daPa Low admittance tympanograms Tympanogram with normal Peak Ya and abnormal gradient (width) LEFT EAR +200 -400...

  • Page 34: High Admittance Tympanograms

    Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument Tympanogram with low Peak Ya LEFT EAR +200 -400 -200 PRESSURE - daPa Conditions which cause tympanograms with reduced peak height (low Peak Ya): • Otitis media with effusion • Tympanosclerosis •...

  • Page 35: Negative And Positive Peak Pressure Tympanograms (Left Or Right Shift)

    Directions for use Interpreting test results Negative and positive peak pressure tympanograms (left or right shift) Tympanogram with negative middle ear pressure LEFT EAR +200 -400 -200 PRESSURE - daPa Conditions which cause negative middle ear pressure: • Eustachian tube dysfunction •...

  • Page 36: Flat Tympanograms

    Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument Flat tympanograms Flat tympanogram with normal ear canal volume LEFT EAR +200 -400 -200 PRESSURE - daPa Condition which causes a flat tympanogram with normal ear canal volume: • Middle ear effusion...

  • Page 37: 1000-Hz Mode

    Directions for use Interpreting test results Tympanograms with artifact RIGHT EAR +200 -400 -200 PRESSURE - daPa Conditions which cause artifact: • Patient movement • Practitioner movement • Vocalizing or crying During the typanometric measurement, the clinician should keep a steady hand, Note and the patient should not talk, chew gum, yawn, cry, or move.

  • Page 38: Normative Values

    Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument Normative values The table below presents normative values for 1000-Hz tympanometry for NICU babies and full-term 2- to 4-week-old babies. [Margolis, R.H., Bass-Ringdahl, S., Hanks, W.D., Holte, K., Zapala, D.A. Tympanometry in Newborn Infants - 1 KHz Norms. J. Amer. Acad.

  • Page 39: Refer

    Directions for use Interpreting test results Refer -400 -200 PRESSURE - daPa Condition which causes a REFER message: • Peak Ya is less than 0.6 mmho Infants with middle ear effusion have lower Peak Ya at 1000 Hz, just as older children have reduced Peak Ya at 226 Hz.

  • Page 40: Influence Of Altitude

    Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument Influence of altitude As the altitude above sea level increases, the admittance of a given volume of air also increases. Therefore, equivalent ear canal volume (+200 Vea) overestimates actual ear canal volume as noted in the table below. To estimate ear canal volume, subtract the appropriate value in the table from the Vea Reading.

  • Page 41: Printing 226-Hz Results

    PRINT button again. Removing the Handle from the well causes the data to be removed from the Printer/Charger memory. • The Printer/Charger has been pre-set at Welch Allyn to print a complete Note printout as illustrated below and to print in manual mode. To change formats...

  • Page 42: Printout Formats

    Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument Printout formats A complete tympanometric printout is shown below. The printout is divided into three sections: tympanogram, data, and interpretive messages. Following is a detailed account of the information presented in each of these sections. For instructions on changing the...

  • Page 43: Data Section

    Directions for use Printing 226-Hz results Data section The data section displays numeric values for the four key characteristics of the tympanogram: • Static Admittance (Peak Ya) is a calculated measure of the compensated static acoustic admittance (height) of the tympanometric peak reported in acoustic millimhos (mmho).

  • Page 44: Select Printout Formats

    Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument Low Peak Height, Large Ear Volume Tympanogram Is Wide Negative Tympanometric Peak Pressure Positive Tympanometric Peak Pressure High Peak Height Normal Tympanogram The computer scans the list of messages and prints the first message that applies. The hierarchy is arranged so that the most clinically-important message is displayed first.

  • Page 45: Change From Manual To Automatic Printout

    Directions for use Printing 226-Hz results Change from manual to automatic printout Automatic vs. Manual Printout (Switch #1) Auto Print Depress the ON portion of the switch to select this option. This causes the printout to begin automatically once the Handle is placed in the well, and data transfer is complete.
  • Page 46 Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument Print interpretive messages (Switch #2) No messages Depress the ON portion of the switch to select this option. This causes messages which interpret the tympanogram to not be included on the printout.

  • Page 47: Printer Function Messages

    Unplug the Printer/Charger. Wait one minute, then re-apply power to the instrument. If Printer/Charger does not return to normal operation, return it to the nearest Welch Allyn service location. Note If the green POWER indicator is not illuminated, verify connection to live power source.
  • Page 48 Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 49: Maintenance And Troubleshooting

    Caution Replace battery with Welch Allyn model #72910 battery only. Note Disassembly of the tympanometer beyond the extent described in this manual will void the warranty. Refer all servicing to Welch Allyn or a Welch Allyn Authorized Service Representative. Replace the battery Replace the rechargeable battery in the handle as follows: Allow the Handle to power down.
  • Page 50 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument 4. Push down on the positive (+) end of the battery. The battery will eject. 5. Insert the new battery by placing the positive (+) end of the battery against the contact in the holder.
  • Page 51 Directions for use Maintenance and troubleshooting Tighten screw in clockwise direction. To avoid stripping the screw threads, do not tighten excessively. 8. Place the Handle into the charging station for a minimum of 10 seconds to enable the battery protection circuit. The unit will not power up if you do not enable the battery protection circuit.

  • Page 52: Replace The Tips

    WARNING Electric shock hazard. Do not attempt to disassemble the Printer/ Charger. Refer all servicing to Welch Allyn or a Welch allyn authorized service representative. Remove the paper access cover by pulling up on the front edge.
  • Page 53 Directions for use Maintenance and troubleshooting 2. Depress the FEED button to advance any remaining paper through the printer. Do not pull paper backwards through the printer. Remove and discard old paper roll. Save the black spindle that guides the paper. 3.

  • Page 54: Cleaning

    Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument Cleaning Clean the handle Clean the Handle by wiping it with a cloth that has been lightly dampened with 70% Isopropyl alcohol. Make sure liquid does not seep into the instrument, especially in the probe area.

  • Page 55: Functional Checks

    Directions for use Maintenance and troubleshooting Functional Checks Check the handle A MicroTest Cavity is included with the Handle. The cavity provides a functional test of the Handle to determine if it is working properly. The 0.5 cc cavity is used to test the Low Range of ear canal volume (Vea).
  • Page 56 If the readings do not fall within the acceptable range, then the Handle requires calibration. Send the Handle to a Welch Allyn service location. As the altitude above sea level increases, the admittance of an air-filled cavity also increases.

  • Page 57: Check The Printer/Charger

    Battery is not charged/dead. Charge/replace the battery. Reset the battery protection circuit. If symptom still persists, return to local Welch Allyn service location for service. Battery protection circuit was Place the Handle in the Printer/Charger for a minimum not reset.
  • Page 58 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument Test Pattern - The test pattern is used to confirm that the print head is functioning properly. If any of the print head elements are not functioning, a white line will appear vertically down the printout.

  • Page 59: A - Middle Ear Pathologies

    Middle ear pathologies Low-admittance pathologies Otitis media with effusion (OME) Otitis media with effusion (OME) is an inflammation of the middle ear accompanied by an accumulation of fluid. Fluid in the middle ear can cause conductive hearing impairment when it interferes with the normal vibration of the eardrum by sound waves. In advanced cases, OME results in flat tympanograms (low Peak Ya).

  • Page 60: Ossicular Disruption

    Middle ear pathologies Welch Allyn MicroTymp3 portable tympanometric instrument vibration with greater ease than the normally stiff tympanic membrane. The result is a high Peak Ya. Although the tympanogram is abnormal, this condition rarely affects hearing sensitivity or requires further medical treatment.

  • Page 61: B - Service And Warranty Information

    Service and warranty information Service Repair Repair must be performed by Welch Allyn authorized personnel. Failure to do so invalidates the warranty. A moderate fee is charged to calibrate the Handle after a repair. Contact Customer Service in your region for service options.

  • Page 62: Warranty

    Warranty Instrument Welch Allyn Inc. warrants the Handle and Printer/Charger to be free of original defects in material and workmanship and to perform in accordance with manufacturer's specifications for a period of one year from the date of purchase. If this instrument or any...

  • Page 63: C - Specifications

    Specifications Physical characteristics 3.68 in 9.35 cm 7.32 in 18.6 cm 1.94 in 4.94 cm POWER CHARGE FEED PRINT -400 -200 PRESSURE - daPa TEST 4.82 in 12.2 cm 9.70 in 24.6 cm 9.62 in 24.4 cm 0297 74227 Patent Pending US Pat #5,383,097 IEC TYPE 3 ANSI TYPE 4...

  • Page 64: Technical Specifications

    Specifications Welch Allyn MicroTymp3 portable tympanometric instrument Technical specifications Probe tone 226-Hz Amplitude: 85 ± 3 dB SPL 1000-Hz Amplitude: 83 ± 3 dB SPL Frequency Accuracy: ± 2% Total Harmonic Distortion: 3% maximum Signal Type: Continuous Sinusoid All specifications measured in an ANSI HA-1 (2.0 cc) coupler.

  • Page 65: Weight

    Directions for use Specifications Display resolution 0.1 mmho for Ya 0.2 cc for +200 Vea Weight Handle: 0.61 lb/0.28 kg Printer/Charger: 3.98 lb/1.81 kg Operating environment Temperature: 15°C to 35°C Relative Humidity: 10% to 90% Barometric Pressure: 700 hPa to 1060 hPa Note No warm-up period is required if the instrument is stored in conditions consistent with the operating environment.

  • Page 66: Printer Paper

    Specifications Welch Allyn MicroTymp3 portable tympanometric instrument Printer paper 4.42 in. (112 mm) wide with core Printer/Chargers Printer/Charger models Welch Allyn Nominal Output Major Geographic Areas Plug Type Model Number 71170 120 V~, 1A Canada, Japan, United States 71172 230 V~, 1A...

  • Page 67: Standards Compliance

    Class I Equipment, Type BF Printer/Charger: Class I Equipment, Type B Authorized European representative address: European Regulatory Manager Welch Allyn, Ltd. Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland Tel. 353 46 28122 Fax 353 46 28536...

  • Page 68: Guidance And Manufacturer's Declaration

    Specifications Welch Allyn MicroTymp3 portable tympanometric instrument Guidance and manufacturer’s declaration Emissions and immunity information Caution The MicroTymp3 needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided. Portable and mobile RF communications equipment can affect the MicroTymp3.
  • Page 69 Directions for use Specifications Electromagnetic Immunity The MicroTymp3 is intended for use in the electromagnetic environment specified below. The customer or user of the MicroTymp3 should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Level Electromagnetic Environment - Guidance Test Level Electrostatic discharge...
  • Page 70 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument Electromagnetic Immunity The MicroTymp3 is intended for use in the electromagnetic environment specified below. The customer or user of the MicroTymp3 should assure that it is used in such an environment. Immunity Test...
  • Page 71 Directions for use Specifications Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the MicroTymp3 The MicroTymp3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the MicroTymp3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MicroTymp3 as recommended below, according to the maximum output power of the communications equipment.
  • Page 72 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument...

  • Page 73: D - Replacement Parts And Accessories

    Replacement parts and accessories Items are not drawn to scale. Note Battery #72910 3.7 V Lithium-ion Screw for Battery Cover #236081 Screw Driver for Battery Cover #236200-2 MicroTest Cavity 2.0 cc 0.5 cc #711772-501 MicroT est CA VITY Probe Tips - Four of the selected size in a bag #24621 #24622...
  • Page 74 Replacement parts and accessories Welch Allyn MicroTymp3 portable tympanometric instrument 1000-Hz Screening Results Cards - Quantity 100: four packs of 25 #55270 Replacement Power Cords (order by plug type) #761076-0 #761076-2 #761076-4 #761076-6 120 V 230 V 230 V 230 V...

  • Page 75: Glossary

    Glossary acoustic admittance The ease with which acoustic energy is transferred into a system; the ratio of volume velocity to sound pressure. acoustic millimho (mmho) The unit of acoustic admittance; 1 mmho = 10 /Pa*s. cholesteatoma See keratoma. decapascal (daPa) The unit of air pressure used for tympanometric measurements. 1 daPa = 1.02 mm H equivalent ear canal volume (+200 Vea) An estimate of the volume of air in front of the probe, measured in cubic centimeters (cc).
  • Page 76 Glossary Welch Allyn MicroTymp3 portable tympanometric instrument static admittance (Peak Ya) A calculated measure of the compensated static acoustic admittance (height) of the tympanometric peak in acoustic millimhos (mmho). tympanogram A recording of the admittance of the ear as a function of ear canal pressure.

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