Directions for use
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MicroTymp 3 portable tympanometric instrument ®
Directions for use
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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. Welch Allyn and MicroTymp are registered trademarks of Welch Allyn. Software in this product is copyrighted by Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America 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 the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. 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, call the nearest Welch Allyn representative: USA
+ 1 315 685 4560 800 535 6663
Australia
+ 61 2 9638 3000 800 074 793
Canada
800 561 8797
China
+ 86 216 327 9631
European Call Center
+ 35 3 46 906 7790
France
+ 33 1 60 09 33 66
Germany
+ 49 7477 92 71 86
Japan
+ 81 3 3219 0071
Latin America
+ 1 305 669 9003
Netherlands
+ 31 15 750 5000
Singapore
+ 65 6419 8100
South Africa
+ 27 11 777 7555
United Kingdom
+ 44 20 7365 6780
Sweden
+ 46 8 58 53 65 51
REF 102921 (CD) 80015401 Ver A
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 -0220 USA
Welch Allyn, Ltd. Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland
www.welchallyn.com
Acknowledgments Welch Allyn gratefully acknowledges the assistance of Robert H. Margolis, Ph.D., of the University of Minnesota for his assistance in preparing the Interpreting tympanogram results and Glossary sections of this manual.
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Contents 1 - Introduction... 7 About this document... 7 Intended use... 7 About the device... 7 Controls, indicators, and connectors... 8 Handle components... 8 Printer/Charger components... 9 Symbols... 10 General warnings... 12 General cautions... 12 General notes... 13 Initial setup... 13 Set up the printer/charger... 13 Set up the handle... 13 Charge the handle... 15
2 - Completing a test... 17 Obtaining a tympanogram... 17 Select a probe tip... 17 Start a test... 17 Store and display data... 20 Erase memory contents... 20 Change the default frequency... 20
3 - Understanding the LCD messages... 23 Company identification... 23 Frequency confirmation... 23 Open... 24 Test... 24 Block... 25 Leak... 25 Right store/Left store... 26 Right clear/Left clear... 26 Low battery... 27 Range error... 27 Zero error... 27 Calibration due... 28 Needs service... 28 System check... 29 Data Transfer... 29
4 - Interpreting test results... 31 Tympanograms... 31 Gradient (width) measurements (226 Hz only)... 32 226-Hz mode... 32
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Contents
Welch Allyn MicroTymp3 portable tympanometric instrument
Normative values... 32 Interpreting 226-Hz tympanogram results... 33 Normal middle ear... 33 Low admittance tympanograms... 33 High admittance tympanograms... 34 Negative and positive peak pressure tympanograms (left or right shift) . . . 35 Flat tympanograms... 36 1000-Hz mode... 37 Tympanometry in young infants... 37 Normative values... 38 Interpreting 1000-Hz results... 38 Pass... 38 Refer... 39 Retest... 39 Influence of altitude... 40 Influence of temperature... 40
5 - Printing 226-Hz results... 41 Print memory contents... 41 Printout formats... 42 Tympanogram section... 42 Data section... 43 Interpretive messages section... 43 Select printout formats... 44 Change from manual to automatic printout... 45 Change printout format... 45 Printer function messages... 47 Printer service codes... 47
6 - Maintenance and troubleshooting... 49 Maintain the equipment... 49 About the battery... 49 Replace the tips... 52 Replace the paper... 52 Cleaning... 54 Functional Checks... 55 Check the handle... 55 Check the printer/charger... 57
A - Middle ear pathologies... 59 Low-admittance pathologies... 59 Otitis media with effusion (OME)... 59 Middle ear tumor... 59 Lateral ossicular fixation... 59 Otosclerosis... 59 Tympanic membrane abnormalities... 59 Ossicular disruption... 60
B - Service and warranty information... 61 Service... 61 Repair... 61 Calibration... 61 Warranty... 62 Instrument... 62 Rechargeable battery... 62
Directions for use
Contents
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C - Specifications... 63 Physical characteristics... 63 Technical specifications... 64 Probe tone... 64 Pressure measurement system... 64 Admittance measurement system... 64 Weight... 65 Operating environment... 65 Storage environment... 65 Battery... 65 Probe tips... 65 Printer paper... 66 Printer/Chargers... 66 Operating ranges... 66 Equivalent units and symbols... 66 Standards compliance... 67 Disposal of non-contaminated electrical and electronic equipment Directive 2002/96/EC-WEEE... 67 Guidance and manufacturer’s declaration... 68 Emissions and immunity information... 68
D - Replacement parts and accessories... 73 Glossary... 75
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Contents
Welch Allyn MicroTymp3 portable tympanometric instrument
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1 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. Before using the tympanometer - or before setting up, configuring, troubleshooting, or servicing the device - you must read and understand this document and all other information that accompanies the tympanometer and its accessories.
Intended use This device is an auditory impedance tester intended to detect possible otologic disorders associated with the functioning of the middle ear.
About the device Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician. Using this device’s 226-Hz and 1000-Hz tympanometry settings, you can quickly and easily obtain objective results supporting diagnosis of otitis media with effusion and other middle ear disorders. This information can result in more thorough diagnoses as well as more effective monitoring, treatment, consultation, and referral. The 226-Hz test data stored in the memory of the Handle may be printed using the Printer/Charger. The Printer/Charger reads the information from the Handle and prints out tympanograms and interpretation. Note
The MicroTymp3 also provides the ability to test patients utilizing a 1000-Hz frequency mode. This mode features a quick interpretation result that displays a Pass, Refer, or Retest message on the LCD (see Chapter 4). Results from the quick interpretation mode can be documented using the 1000-Hz screening results card. Results from the 1000-Hz quick interpretation mode will not print.
The Printer/Charger also charges the rechargeable battery in the Handle.
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Introduction
Welch Allyn MicroTymp3 portable tympanometric instrument
Controls, indicators, and connectors Handle components Front view
2 GR A
Ya - mmho
1.0
Tip
1 0.5
GR C
Liquid Crystal Display (LCD)
+200 Vea - cc
Side view
0 -400
-200
0
200
PRESSURE - daPa
Left memory button
TEST
Probe Test button Tip ejector
Right memory button
®
MicroTymp 3
Portable Tympanometric Instrument
Battery cover
0297 C
US
74227
Patent Pending US Pat #5,383,097 IEC TYPE 3 ANSI TYPE 4 REF Skaneateles Falls, NY USA 23650
Infrared data transfer window
Interior view
Bottom view
ON ON CTS
-
1 2 3 4
REF 72910
+
Lithium Ion
Micro-USB port NOTE: Reserved for future use
OFF
ON ON CTS
1 2 3 4 OFF
Lithium-ion battery Handle switches
Directions for use
Introduction
Printer/Charger components CHARGE indicator
FEED button PRINT button
Tip box
POWER 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 cover
Paper slot
Power Cord
To power receptacle
To IEC power cord receptacle
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Welch Allyn MicroTymp3 portable tympanometric instrument
Symbols Documentation symbols Warning (Warnings indicate conditions or practices that could lead to illness, injury, or death.)
Caution (Cautions indicate conditions or practices that could damage the equipment or other property)
Consult instructions for use
Hot surface
Operation symbols POWER indicator
FEED button
CHARGE indicator
PRINT button
TEST button
RIGHT memory button R
TEST
GR A
Gradient width adult
GR C
Gradient width child
LEFT memory button L
Switch options ON/OFF symbol
Shipping, storing, and environment symbols +49ºC Temperature limits
95%
Relative humidity limit
-20ºC
This end up
Recycle
Recycle the product separate from other disposables. See www.welchallyn.com/ weee for collection point and additional information.
Separate batteries from other disposables for recycling.
Power and connectivity symbols Lithium-ion
Directions for use
Introduction
Certification symbols Complies with applicable U.S. and Canadian medical safety standards
Meets essential requirements of European Medical Device Directive 93/42/EEC
0297
74227
Class I equipment, Type BF (Handle)
European regulatory manager
Class I equipment, Type B (Printer/Charger)
Miscellaneous symbols
REF SN
Reorder number
Serial number
Manufacturer
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Welch Allyn MicroTymp3 portable tympanometric instrument
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. The user is responsible for verifying that the system complies with the requirements of the system standard IEC 60601-1-1 if additional devices are connected to the MicroTymp Handle. WARNING Improper handling or disposal of the battery can lead to heat generation, smoke, bursting, or fire. WARNING Do not disassemble, modify, or solder the battery.
WARNING Do not directly connect (short circuit) the positive (+) and negative (-) battery terminals. WARNING To avoid short circuits, keep the battery terminals away from metal objects. WARNING Do not dispose of the battery in fire.
WARNING Do not expose the battery to temperatures above 80°C (176°F).
WARNING Use only the specified charger to charge the battery.
General cautions Caution Charge only Handle #23640, Handle # 23650, or AudioScope 3 (#23300) in the Printer/Charger. Caution If the device has not been stored within the operating temperature range, allow 24 hours minimum for it to return to operating temperature range (15-35°C or 59-95°F) before using.
Directions for use
Introduction
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Caution Do not store either the Handle or Printer/Charger at temperatures below -20°C (-4°F) or above +49°C (120°F). Continual exposure to extremely low or high temperatures can permanently damage components. Caution The battery must be removed if the Handle is to be stored or placed anywhere other than in the powered Printer/Charger for more than one month. Failure to do this can result in damage to the Handle. Caution This instrument contains components which are static sensitive. Before touching any internal handle component, be sure that you have discharged any static electricity by touching a grounded metal object. Caution To prevent equipment damage, charge the Handle only with the Printer/Charger (#7117x).
General notes The MicroTymp Printer/Charger (#7117x) will charge and print data from the MicroTymp2 or 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 1.
Place the Printer/Charger on a flat, horizontal surface.
2. Plug the power cord into the receptacle in the rear of the Printer/Charger, then connect the power cord to a receptacle with proper voltage, frequency, and plug type. The solid green POWER indicator will illuminate to indicate that the Printer/Charger is receiving power.
Set up the handle Install the rechargeable battery in the handle as follows: 1.
Unscrew the battery cover in a counterclockwise direction using the #1 Phillips head screwdriver provided. Save the screw.
+ + +
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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. Push the battery lightly to compress the contact, and lower the battery into the compartment. Note
Insert the battery only as shown. Failure to observe the correct polarity will prevent the instrument from functioning.
+
m REF 72910 Lithiu Ion
4. Replace the cover by inserting the tip end under the front cover, lowering the opposite end, and replacing the screw.
+ REF 72910
Lithium
5. Tighten screw in clockwise direction. To avoid stripping the screw threads, do not tighten excessively.
Directions for use
Introduction
Charge the handle 1.
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. See Ch. 2 for instructions to take a test.
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Welch Allyn MicroTymp3 portable tympanometric instrument
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2 Completing a test Obtaining a tympanogram Select a probe tip 1.
After examining the subject's ear canal opening, select a tip which is large enough to seal the entrance of the ear canal. To change tips, either pull the tip off by hand or slide the tip ejector towards the tip.
Note
Tips are not intended to be deeply inserted into the ear canal. Using an improper tip size causes leaks, and will make it difficult to complete a test. Use only MicroTymp3 tips with the MicroTymp3 Handle.
Pinna Seal External ear canal Tympanic membrane Tip Probe Tip ejector
2. Push the tip onto the probe, making sure that the tip is fully seated.
Start a test
2 GR A
1.0
1
0.5 0 -400
GR C -200
0
PRESSURE - daPa
200
+200 Vea - cc
Pick up the handle and press any button. The Welch Allyn screen will display.
Ya - mmho
1.
Completing a test
Note
Welch Allyn MicroTymp3 portable tympanometric instrument
Time-out feature. The tympanometer automatically turns off 15 seconds after the last test or button activation.
0.5
GR C
0 -400
2 GR A
1.0
1
0.5
GR C
0 -200
0
200
-400
PRESSURE - daPa
Note
+200 Vea - cc
1
Ya - mmho
2 GR A
1.0
+200 Vea - cc
Ya - mmho
2. Press the TEST button below the Liquid Crystal Display (LCD) to show the current frequency. One of the screens shown below will appear.
-200
0
200
PRESSURE - daPa
The default frequency set at the factory is 226 Hz. To change the default frequency to 1000 Hz, see the instructions at the end of this chapter.
0 -400
GR C -200
0
PRESSURE - daPa
200
2 GR A
1.0
1
0.5 0 -400
GR C -200
0
+200 Vea - cc
1
0.5
Ya - mmho
2 GR A
1.0
+200 Vea - cc
3. To switch to the other frequency, press both the R Right memory and L Left memory buttons on the handle simultaneously until the desired frequency displays, as shown below. Pressing the two memory buttons repeatedly toggles between these two screens.
Ya - mmho
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200
PRESSURE - daPa
4. Press the TEST button again to confirm the desired frequency. Either the OPEN 226 or OPEN 1000 screen will display, as shown in step 2. 5. Once you’ve confirmed the desired frequency, proceed with the test. Grasp the subject's pinna. Pull gently back to straighten the child's ear canal (or up and back for adults). See the image on the left below. 6. While maintaining tension on the pinna, press the tip firmly against the ear canal opening. See the image on the right below. Point the tip straight into the ear canal for adults and slightly anteriorly for children.
Directions for use
Completing a test
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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.
Note
If the BLOCK, LEAK, or OPEN messages appear during the test, reposition the tip to restart the test.
Once a seal is achieved, the TEST message appears on the LCD, followed by the volume indication on the +200 Vea scale.
0.5 0 -400
GR C -200
0
1
0.5 0 -400
200
PRESSURE - daPa
R
2 GR A
1.0
GR C -200
0
+200 Vea - cc
1
Ya - mmho
2 GR A
1.0
+200 Vea - cc
Ya - mmho
For 226 Hz, data points are displayed from right to left across the LCD as the test progresses. The test is complete when the last data point is displayed. The image below on the left illustrates the execution of a complete test. If patient or instrument movement causes a leak beyond -100 daPa in 226-Hz mode, the test will be stopped but the data will be saved. See the figure on the right below.
200
PRESSURE - daPa
TEST
L
R
TEST
L
0.5 0 -400
GR C -200
0
200
Note
TEST
1
0.5 0 -400
GR C -200
0
200
PRESSURE - daPa
PRESSURE - daPa
R
2 GR A
1.0
+200 Vea - cc
1
Ya - mmho
2 GR A
1.0
+200 Vea - cc
Ya - mmho
For 1000 Hz, the test is complete when one of two “Quick-Interpretation” messages appears--either PASS or REFER--as shown in the examples below. If patient or instrument movement causes a leak beyond -300 daPa in 1000-Hz mode, the test will be stopped but the data will be saved.
L
R
TEST
L
A RETEST message may also appear, indicating that you should rerun the test.
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Completing a test
Welch Allyn MicroTymp3 portable tympanometric instrument
Store and display data 1.
To store the results of the test, press the button which matches the tested ear, as illustrated below. The memory buttons are labeled R for the right ear and L for the left ear. When test results are stored in memory, the RIGHT STORE or LEFT STORE message appears momentarily on the LCD. Then the tympanogram which has been stored reappears along with the right or left symbol (to indicate the contents of that memory).
2 GR A
1.0
1
0.5
GR C
+200 Vea - cc
Ya - mmho
L
0
200
2 GR A
Ya - mmho
1.0
1 0.5
GR C
0 -400
-200
0
200
2 GR A
1.0
1
0.5
GR C
0 -400
-200
0
+200 Vea - cc
-200
PRESSURE - daPa
Ya - mmho
-400
+200 Vea - cc
0
200
PRESSURE - daPa
PRESSURE - daPa
2. Press either the Left or Right memory button to recall the information stored in memory. You may recall memory contents at any time.
Erase memory contents You can erase memory contents in two ways: •
By storing a new test. The device automatically erases the previous test when you store a new test.
•
By pressing either the Left or Right memory button for more than three seconds. This action erases memory contents for that ear.
Change the default frequency The default frequency set at the factory is 226 Hz. However, if the majority of your patients are infants less than six months old, you may set 1000 Hz as the default frequency. Use the procedure below to switch from one frequency to another. 1.
Allow the Handle to power down.
2. Unscrew the battery cover in a counter clockwise direction using the #1 Philips screwdriver provided. Save the screw.
+ + +