Welch Allyn MicroTymp User manual

R
Audio Menu
Service Manual
1.0
0.5
0
-400
-200
PRESSURE - DaPa
TEST
Portable Tympanometric
2
GR A
1
GR
C
+200 Vea - cc
0
200
L
Instrument
POWER
CHARGE
FEED
PRINT
Operating Instructions

Acknowledgments

Welch Allyn gratefully acknowledges the assistance of Robert H. Margolis, Ph.D. of the University of Minnesota for his assistance in preparing the Guide to Tympanometry and Glossary sections of this manual.
Trademarks
Welch Allyn and MicroTymp are registered trademarks of Welch Allyn, Inc. in the United States and other countries.
Patents
MicroTymp – U.S. Patent Number 4,688,582 Conductive Path ESD Shield – U.S. Patent Number 5,383,097

Contents

MicroTymp2 – Introduction
MicroTymp2 Handle Components .............................................................2
MicroTymp2 Printer/Charger Components ................................................3
Preparing to Use the MicroTymp2 Handle and Printer/Charger................ 3
Setting up the MicroTymp2 Handle and Printer/Charger ...................... 4
MicroTymp2 – Completing a Test
Obtaining a Tympanogram.........................................................................5
Selecting a Probe Tip .............................................................................5
Testing....................................................................................................6
Storing and Erasing Data .......................................................................7
Displaying Memory Contents .................................................................8
Erasing Memory Contents......................................................................8
Understanding the Liquid Crystal Display (LCD) and Its Messages .......... 8
Gradient (Width) Measurements.............................................................8
Printing Memory Contents .......................................................................15
MicroTymp2 Printout Formats..................................................................16
Description of Formats .........................................................................16
Selecting Printout Formats.......................................................................20
Changing from Manual to Automatic Printout ......................................20
Changing Printout Format ....................................................................21
Printer Function Messages ......................................................................23
Printer Service Codes ..............................................................................24
Appendix A – Guide to Tympanometry
Basic Principles of Tympanometry ....................................................... A-25
Tympanogram Characteristics ............................................................. A-26
How the MicroTymp2 Instrument Works..............................................A-27
Normative Values for the MicroTymp2 ................................................. A-28
Interpreting Tympanogram Results ......................................................A-29
Obtaining a Valid Tympanogram ....................................................... A-31
Tympanometry in Young Infants .......................................................A-31
Conditions Which Cause Too Much Artifact.....................................A-31
Conditions Which Artificially Flatten the Tympanogram....................A-32
The Normal Ear ................................................................................ A-33
Low-Admittance Pathologies ...........................................................A-34
Tympanic Membrane Abnormalities .................................................A-36
Conditions Which Cause Negative Middle Ear Pressure ..................A-37
Conditions Which Cause Positive Middle Ear Pressure....................A-37
Appendix B – Guidelines for Screening for Hearing Impairments
and Middle Ear Disorders ..................................................................B-39
Recommended Screening Protocol.....................................................B-41
Audiological or Medical Referral .......................................................B-42
Appendix C – Maintaining the MicroTymp2 Equipment
The MicroTymp 2 Battery.....................................................................C-43
Recharging the Battery ....................................................................C-46
Recycling the Battery .......................................................................C-47
Paper Replacement .............................................................................C-48
Cleaning, Disinfection and Sterilization ................................................C-50
Cleaning the MicroTymp 2 Handle ....................................................C-50
Printer/Charger Cleaning..................................................................C-50
Disinfection and Sterilization of the Probe Tips ................................C-50
Appendix D – Functional Checks of the MicroTymp2 Handle and Printer/Charger
Functional Checks of the MicroTymp 2 Handle ....................................D-51
Troubleshooting the MicroTymp 2 Handle .........................................D-53
Functional Checks of the Printer/Charger............................................D-53
Appendix E – Service and Warranty Information
Service ................................................................................................. E-55
Repair............................................................................................... E-55
Recalibration .................................................................................... E-55
Warranty............................................................................................... E-56
MicroTymp2 Instrument.................................................................... E-56
MicroTymp2 Rechargeable Battery .................................................. E-56
Appendix F – Technical Specifications .............................................. F-57
Appendix G – MicroTymp 2 Replacement Parts and Accessories . G-61
References ................................................................................................63
Glossary .....................................................................................................65
MicroTymp2 – Introduction
Thank you for purchasing the Welch Allyn MicroTymp 2 Portable Tympan­ometric Instrument.
The Welch Allyn MicroTymp2 provides portable tympanometry which is automatic, easy to use, and offers the following features:
• Measures middle ear function in as little as one second
• Displays results as they happen
• Stores data from two ears before printing
• Prints out hardcopy automatically or on demand in five seconds
With MicroTymp2 tympanometry, objective, printed documentation of otitis media with effusion and other middle ear disorders is quickly and easily obtained. This results in more thorough diagnoses, and more effective monitoring, treatment, parent consultation, and referrals.
Data stored in the memory of the MicroTymp2 Handle may be printed using the Printer/Charger. The Printer/Charger reads the information from the Handle and quietly prints out tympanograms from two ears with test results in five seconds.
The MicroTymp2 Printer/Charger also charges the rechargeable battery in the MicroTymp2 Handle.
This manual describes how to operate and maintain the MicroTymp2 Handle and Printer/Charger. Please follow these instructions to ensure many years of accurate and reliable service. For additional information on the science of tympanometry, refer to “A Guide to Tympanometry” (Appendix A, page A-25).
1
MicroTymp2 Handle Components
2
GR
1.0 A
Tip Probe
Tip Ejector
Battery Cover
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
RLTEST
1
GR C
+200 Vea - cc
Liquid Crystal Display (LCD)
Left Memory Button
Test Button Right Memory
Button
Charging Contacts
Infrared Data Transfer Window
Figure 1A
2
MicroTymp2 Printer/Charger Components
Charging Well for MicroTymp2
Tip Box
POWER Indicator
Paper Access Cover
CHARGE Indicator
POWER CHARGE FEED PRINT
Paper Slot
Power Cord
FEED Button
PRINT Button
TM
IEC Power Cord Receptacle
Printer/Charger Switches
134
2
OFF
To Power Receptacle
To IEC Power Cord Receptacle
Figure 1B
Preparing to Use the MicroTymp2 Handle and Printer/Charger
The following is a list of important facts to note before using the MicroTymp2.
• Please complete and return the warranty registration card. It validates the warranty, and allows Welch Allyn to communicate recalibration notices and software changes.
3
• If the MicroTymp 2 set has not been stored at room temperature, allow 45 minutes for it to return to operating temperature range (15-35˚C or 59-95˚F) before using.
• Do not store either the MicroTymp2 Handle or Printer/Charger at temperatures which exceed 66˚C (150˚F). Continual exposure to ex­tremely high temperatures can permanently damage components.
Refer to Operating Instructions manual.
!
DANGER: Explosion risk if Printer/Charger is used with flammable anesthetics.
CAUTION: Disassembly of the Printer/Charger presents a possible electrical shock hazard. Refer all servicing to Welch Allyn or a Welch Allyn authorized service representative listed on page E-55.
Disassembly of the MicroTymp2 Handle or Printer/Charger
!
beyond the extent described in this manual will void the warranty. Refer all servicing to Welch Allyn or a Welch Allyn authorized service representative listed on page E-55.
Disconnect from the mains via the appliance inlet.
!
Charge only MicroTymp 2 Handle (#23640), MicroTymp Handle
!
(#23600), or AudioScope 3 (#23300) in the MicroTymp 2 Printer/Charger.
BATTERY REPLACEMENT: Replace with Welch Allyn model
!
#72900 battery only. NOTE: The MicroTymp
data from the original MicroTymp Handle. However, the original MicroTymp Printer/Charger will neither charge nor print data from the MicroTymp Stand (#71126) is available for charging only.
2 Printer/Charger will charge and print
2 Handle. A special AudioScope Charging
Setting up the MicroTymp2 Handle and Printer/Charger
• Install the MicroTymp2 rechargeable battery in the Handle by following the instructions found on page C-43 of this manual.
• Place the Printer/Charger on a flat, horizontal surface.
• Plug the power cord into the receptacle in the rear of the Printer/ Charger. Then connect the power cord to a receptacle of proper voltage, frequency, and plug type. The green POWER to indicate that the Printer/Charger is operating properly. See Figure 1A and 1B (pages 2 and 3).
4
indicator will illuminate
MicroTymp2 – Completing a Test

Completing a Test

MicroTymp

Obtaining a Tympanogram

Selecting 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. See Figure 2.
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.
Pinna
Seal
External Ear Canal
Tympanic Membrane
Tip
Probe
2
Tip Ejector
Figure 2
2. Push the tip onto the probe, making sure that the tip is fully seated.
5

Testing

2 A
+200 Vea -
TEST
button below
GR
cc
3. Turn on the MicroTymp 2 Handle by pressing the TEST the Liquid Crystal Display (LCD). The word “OPEN” appears on the LCD. Figure 3 illustrates the TEST button and the OPEN message.
TEST
1.0
0.5
OPEN
Ya - mmho
0
-400 -200 0 200 1
PRESSURE - DaPa
RL
GR
C
TEST
Figure 3
NOTE: The MicroTymp2 automatically turns off 15 seconds after the last test or activation of any button.
Figure 4 Figure 5
4. Grasp the subject’s pinna. Pull gently back to straighten the child’s ear canal (or up and back for adults). See Figure 4.
5. While maintaining tension on the pinna, press the tip firmly against the ear canal opening. See Figure 5. Point the tip straight into the ear canal for adults and slightly anteriorly for children.
6
Completing a Test
MicroTymp
NOTE: Due to 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 practitioner’s hand is steady, and that the subject does not talk, yawn, chew gum, cry, or make any other similar movements.
If a seal is not achieved, the LCD will display a LEAK, BLOCK, or OPEN message. Reposition the instrument to attempt another test.
6. Once a seal is achieved, the TEST message appears on the LCD, followed by the volume indication on the +200 Vea scale. Data points are then displayed from right to left across the LCD as the test progresses. If the BLOCK, LEAK, or OPEN messages appear during the test, reposition the tip to restart the test.
The test is complete when the last data point is displayed. Figure 6A illustrates the execution of a complete test (approximately 1.8 seconds). If patient or instrument movement causes a leak beyond -100 daPa, the test will be stopped (approximately 1.0 seconds), but the data will be saved. See Figure 6B.
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
1
GR
A
GR
C
+200 Vea - cc
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
GR
A
1
GR
C
2
+200 Vea - cc
RLTEST
RLTEST
Figure 6A Figure 6B

Storing and Erasing Data

7. To store the results of the test, press the button which matches the tested ear, as illustrated in Figure 7.
7
The memory buttons are labeled for the right ear and L for the left
R
ear. When test results are stored in memory, the RIGHT STORE or LEFT STORE message (see Figure 7A) appears momentarily on the LCD. Then the tympanogram which has been stored reappears along with the
R
right
or left L symbol (see Figure 7B) to indicate the contents of
that memory.
2
-400 -200 0 200
PRESSURE - daPa
RLTEST
GR A
1
GR C
+200 Vea - cc
2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
1
GR
A
GR
C
1.0
0.5
Ya - mmho
+200 Vea - cc
0
-400 -200 0 200
PRESSURE - daPa
1.0
0.5
Ya - mmho
0
Figure 7 Figure 7A Figure 7B

Displaying Memory Contents

Information stored in memory may be recalled at any time by depressing the appropriate memory button.

Erasing Memory Contents

There are two ways to erase memory contents:
• When a test is stored, the previous test is automatically erased.
R
• Depressing either the right three seconds erases that memory.
or left L memory button for more than
L
2
GR
A
1
GR
C
+200 Vea - cc
Understanding the Liquid Crystal Display (LCD) and Its Messages
The following messages may be displayed on the LCD during MicroTymp2 Handle operation:
Gradient (Width) Measurements
When a tympanometric tracing is complete, the MicroTymp2 measures the gradient or width of the tympanogram. If the gradient is abnormal, an asterisk will appear on the LCD under years of age), or
GR
for the child’s ear (10 years of age or younger). For more
C
information, see Appendix A, “Guidelines for Tympanometry”, and Appendix B, “Guidelines for Screening”.
GR
for the adult’s ear (greater than 10
A
8

LIQUID CRYSTAL DISPLAY

Normal Static Admittance and TPP (Adults)
Normal Static Admittance and TPP (Children)
Completing a Test
MicroTymp
2
Admittance Axis
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
1
GR
GR
A
C
Gradient (Width) Adult
Gradient (Width) Child
+200 Vea - cc
Pressure Axis
Figure 8
A sample of the Liquid Crystal Display is shown in Figure 8.

OPEN

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 9
GR
1
GR
A
C
+200 Vea - cc
The test has not begun since a valid ear cavity has not been detected. The ear canal volume exceeds 2.5 cc.
Possible causes:
• instrument is not in an ear
• probe tip is not completely sealed in an ear
• instrument is used on perforated tympanic membrane, an ear with patent tympanostomy tubes, or an extremely large canal (> 2.5 cc).
9

TEST

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
GR
1
GR
A
C
+200 Vea - cc
Figure 10
The TEST message indicates that the test has started. Immediately following this message, test data will begin to appear.

BLOCK

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 11
GR
1
GR
A
C
+200 Vea - cc
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 or tortuous canal
• probe tip is clogged with cerumen
Possible solutions:
• reposition the probe tip
• perform otoscopy to check for occlusion
• remove cerumen from probe tip
10

LEAK

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 12
The test cannot proceed since desired pressures within the ear have not been achieved.
Possible causes:
• probe tip is not completely sealed in the ear canal
• excessive movement of patient or practitioner
• probe tip dislodged during a test
Possible solutions:
• reposition probe tip
• patient and practitioner must remain still
• use a different size probe tip
• increase pressure against the ear
GR
1
GR
A
C
+200 Vea - cc
Completing a Test
MicroTymp
2
If a leak condition occurs after -100 daPa pressure is reached, results will remain on the display. If an identifiable peak is displayed, the test need not be repeated. If no peak can be identified, repeat the test and try reposition­ing the tip, using a different size tip, or increasing the pressure against the ear canal opening.

RIGHT STORE/LEFT STORE

1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
1
GR
GR
A
C
+200 Vea - cc
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
Figure 13A Figure 13B
Test results have been stored in the designated memory location. Immedi­ately following this message, the newly-stored tympanogram reappears along with the right
R
or left L symbol. For instructions on storing and
erasing data, see page 7.
11
2
GR
1
GR
A
C
+200 Vea - cc

RIGHT CLEAR/LEFT CLEAR

1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
GR
1
GR
A
C
+200 Vea - cc
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
2
GR
1
GR
A
C
+200 Vea - cc
Figure 14A Figure 14B
The designated right
R
or left L memory location contains no data. Either no data has been stored, or previously stored data has been erased. See page 7 for information on storing and erasing data.

LOW BATT(ery)

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 15
The LOW BATT message indicates that the battery needs to be recharged. All buttons are disabled to prevent inaccurate results due to inadequate battery voltage. Normal operation may be restored by recharging the battery or replacing the battery with a charged battery. Stored data is not lost when the battery is removed.
GR
1
GR
A
C
+200 Vea - cc
NOTE: The battery must be removed if the MicroTymp2 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 MicroTym p2 Handle.
See Appendix C, “Maintaining the MicroTymp2 Equipment,” for instructions on removing and recharging the battery.
12

RANGE ERROR

1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 16
2
GR
1
GR
A
C
Completing a Test
MicroTymp
2
+200 Vea - cc
The RANGE ERROR message indicates that a large pressure change occurred during a test. If this message appears, press the TEST
TEST
button and start the test again.

ZERO ERROR

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
Figure 17
The ZERO ERROR message indicates that a large pressure change occurred during automatic pressure compensation at the start of a test. If this message appears, press the TEST
TEST
button and start the test again.
GR
1
GR
A
C
+200 Vea - cc
13

NEEDS CAL(ibration)

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
GR
1
GR
C
A
+200 Vea - cc
Figure 18
Something has caused the MicroTymp2 to fail an internal calibration test. All MicroTymp2 buttons have been disabled because the instrument needs to be returned to a Welch Allyn service location for calibration. Any results already stored in the handle may be printed.
Annual recalibration is recommended to insure instrument accuracy. See Appendix E, “Service and Warranty Information,” for details on service locations and recalibration.

DATA XFER(transfer)

2
1.0
0.5
Ya - mmho
0
-400 -200 0 200
PRESSURE - daPa
GR
A
1
GR
C
+200 Vea - cc
Figure 19
The data stored in the MicroTymp2 Handle is being transferred to the Printer/Charger.
14
Completing a Test
MicroTymp

Printing Memory Contents

Follow the steps listed below to print tympanometric data stored in the MicroTymp2 Handle:
1. Place the MicroTymp2 Handle in the well with the Liquid Crystal Display
(LCD) and buttons facing you. See Figure 20. When the MicroTymp2 is properly seated in the well, the green CHARGE
indicator illuminates.
2. Press the PRINT
3. To feed extra paper, press the FEED
feed as long as the button is depressed.
button.
button. Paper continues to
2
Figure 20
15
4. To remove the printout, pull the paper forward and to the left or right to
tear it along the cutting edge.
5. To obtain an additional copy of the test results, leave the Handle in the
well and press the PRINT Handle from the well causes the data to be removed from the Printer/ Charger memory.
NOTE:
• The Printer/Charger has been pre-set at Welch Allyn to print a complete printout as illustrated in Figure 21 on page 17, and to print in manual mode. To change formats or print in automatic mode, follow the instructions on page 20.
• If only one ear has been tested, the memory for the other ear should be erased (see page 8) so as not to confound current data with data from a previous patient.
• If only one memory location has data, only one result is printed.
• Do not use transparent adhesive tape on the printed portions of a printout, as those portions will then fade.
button again. Removing the MicroTymp2
MicroTymp2 Printout Formats
Description of Formats
A complete tympanometric printout is shown in Figure 21. 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 format of the printout, see page 20.
16
Tympanogram
Data (Optional)
Interpretive Message (Optional)
Completing a Test
MicroTymp
2
Figure 21
Tympanogram Section of Printout
The tympanogram is a graph which records the admittance of the ear as a function of air pressure.
Data Section of Printout
The data section displays numeric values for the four key characteristics of the tympanogram:
Peak Ya — the compensated static acoustic admittance (height) of the peak, measured in acoustic millimhos (mmho).
Gradient (GR) — the width of the tympanogram; the distance across the tympanogram measured at a height 50% down from the peak, measured in decapascals (daPa).
Tympanic Peak Pressure (TPP) — where the tympanometric peak occurred on the pressure axis, measured in decapascals (daPa).
Volume of the Ear Canal (Vea) — acoustically-determined ear canal volume, measured in cubic centimeters (cc) at +200 daPa.
17
If the numeric values are greater or less than the 90th percentile of the normative data for a child or an adult, an asterisk appears under the C(hild) or A(dult) column. The normative data are listed in Table 1 below.
For some tympanometric results, no data will be printed. These occasions are:
• Peak Ya is greater than 1.5 mmhos. The message “High Peak Ya” will appear at the top of the tympanogram.
• Peak Ya less than 0.3 mmhos.
• Peak Ya which is incomplete; for example, a negative pressure tympanogram which is so far negative that the peak has not been reached and data are incomplete.
• Tympanogram has too much artifact. Artifact is generally caused by movement of the subject or the instrument.
Table 1 — Normative Tympanometric Data
Tympanometric Child’s Ear Adult’s Ear Measurement (Under Age 10) (Over Age 10)
90% Range 90% Range
Peak Ya 0.2 to 0.9 mmho 0.3 to 1.4 mmho Gradient (GR)
(Tympanometric Width) 60 to 150 daPa 50 to 110 daPa Tympanometric
Peak Pressure (TPP) -139 to +11 daPa -83 to 0 daPa Equivalent Ear Canal
Volume (Vea) 0.4 to 1.0 cc 0.6 to 1.5 cc
NOTE: For purposes of tympanometric norms, an adult is defined as a person 10 years of age or older, and a child as under age 10.
Normative data are taken from a study by Margolis and Heller (1987), and from the “Guidelines for Screening for Hearing Impairments and Middle Ear Disorders” ASHA (1990).
18
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