Welch Allyn MicroTymp 3 portable tympanometric instrument User Manual

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MicroTymp

3 portable tympanometric instrument

Directions for use

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ii Welch Allyn MicroTymp3 portable tympanometric instrument

REF

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

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

102921 (CD)

80015401 Ver A

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 -0220 USA

www.welchallyn.com

800 535 6663

Welch Allyn, Ltd. Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

Australia + 61 2 9638 3000

800 074 793

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

iii

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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iv 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

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Directions for use Contents v

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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vi Contents Welch Allyn MicroTymp3 portable tympanometric instrument

Page 7

Note

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.

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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8 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument

Liquid Crystal Display (LCD)

Left memory button

Test butto n

Right memory button

Infrared data transfer window

Tip

Probe

Tip ejector

Battery cover

Micro-USB port NOTE: Reserved for future use

Lithium-ion battery

Side view Front view

Bottom view

Interior view

Handle switches

Controls, indicators, and connectors

Handle components

1.0 A

0.5

Ya - mmho

PRESSURE - daPa

TEST

Portable Tympanometric Instrument

MicroTymp

+200 Vea - cc

-400 -200 0 200

74227

Patent Pending IEC TYPE 3

ANSI TYPE 4

Skaneateles Falls, NY USA

0297

US Pat #5,383,097

REF 23650

ON CTS

REF

72910

Lithium

Ion

ON CTS

123

OFF

123

OFF

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Directions for use Introduction 9

Power Cord

Tip bo x

POWER indicator

CHARGE indicator

FEED button

PRINT button

Paper slot

Paper access cover

Charging well for MicroTymp 2 or 3

Card holder with 1000-Hz screening results cards

IEC power cord receptacle

Printer/Charger switches

To IEC power cord receptacle

To pow e r receptacle

Printer/Charger components

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10 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument

TEST

-20ºC

+49ºC

95%95%

Symbols

Documentation symbols

Warning (Warnings indicate conditions or practices that could lead to illness, injury, or death.)

Consult instructions for use Hot surface

Operation symbols

POWER indicator FEED button

CHARGE indicatorPRINT button

TEST button RIGHT memory button

Gradient width adult LEFT memory button

Gradient width child Switch options ON/OFF symbol

Caution (Cautions indicate conditions or practices that could damage the equipment or other property)

Shipping, storing, and environment symbols

Temperature limits Relative humidity limit

This end up Recycle

Recycle the product separate from other disposables. See www.welchallyn.com/ weee for collection point and additional information.

Power and connectivity symbols

Lithium-ion

Separate batteries from other disposables for recycling.

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Directions for use Introduction 11

0297

REF

Certification symbols

Meets essential requirements of European Medical Device Directive 93/42/EEC

74227

Class I equipment, Type BF (Handle)

Class I equipment, Type B (Printer/Charger)

Miscellaneous symbols

Reorder number Manufacturer

Complies with applicable U.S. and Canadian medical safety standards

European regulatory manager

Serial number

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12 Introduction 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.

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Directions for use Introduction 13

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.

Page 14

14 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument

Note

72910

REF

Lithium

Ion

72910

REF

Lithium

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.

Insert the battery only as shown. Failure to observe the correct polarity will prevent the instrument from functioning.

4. Replace the cover by inserting the tip end under the front cover, lowering the opposite end, and replacing the screw.

5. Tighten screw in clockwise direction. To avoid stripping the screw threads, do not tighten excessively.

Page 15

Directions for use Introduction 15

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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16 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument

Page 17

Note

Pinna

Tip ejector

Tip

Probe

Seal

External ear canal

Tym pa ni c

membrane

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

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.

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.

Start a test

2. Push the tip onto the probe, making sure that the tip is fully seated.

1. Pick up the handle and press any button. The Welch Allyn screen will display.

Page 18

18 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument

Note

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Time-out feature. The tympanometer automatically turns off 15 seconds after the last test or button activation.

2. Press the button below the Liquid Crystal Display (LCD) to show the

TEST

current frequency. One of the screens shown below will appear.

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -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.

3. To switch to the other frequency, press both the Right memory and 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.

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

4. Press the button again to confirm the desired frequency. Either the

TEST

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.

Page 19

Directions for use Completing a test 19

Note

RLTEST

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

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.

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.

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.

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

RLTEST

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

RLTEST

+200 Vea - cc

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.

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

RLTEST

A RETEST message may also appear, indicating that you should rerun the test.

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20 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument

-400 - 200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

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 for the right ear and 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).

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

Ya - mmho

1.0

0.5

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:

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

• 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.

Page 21

Directions for use Completing a test 21

72910

REF

Lithium

ON CTS

OFF

123

ON CTS

OFF

123

72910

REF

Lithium

Ion

ON = 226 Hz OFF = 1000 Hz

3. Remove the Handle cover by lifting the bottom of the cover away from the probe tip.

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.

Caution Potential damage to Handle. Do not use the screwdriver provided or any other metal object to move the switch.

5. Replace the cover by inserting the tip end under the front cover, lowering the opposite end, and replacing the screw.

6. Tighten the screw in a clockwise direction. To avoid stripping the screw threads, do not tighten excessively.

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22 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument

Page 23

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

TEST

Understanding the LCD messages

The following messages may be displayed on the LCD during Handle operation.

Company identification

The Welch Allyn message will appear when you press any button.

Frequency confirmation

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

These messages indicate the unit’s frequency options. You can toggle between frequencies by simultaneously pressing both the Right memory and Left memory buttons.

Press to confirm selected frequency and to exit frequency confirmation mode.

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24 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument

Open

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

The test has not begun since a valid ear cavity has not been detected.

Possible causes:

• Instrument is not in an ear

• Probe tip is not completely sealed in an ear

• Perforated tympanic membrane

• Ear with patent tympanostomy tubes

• Extremely large canal (> 2.5 cc)

Possible solutions:

• Reposition the probe tip

• Perform otoscopy to check for perforated membrane or patent tympanostomy tubes

Test

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

The TEST message indicates that the test has started. Test data will begin to appear immediately.

Page 25

Directions for use Understanding the LCD messages 25

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

• Probe tip is clogged with cerumen

Leak

Possible solutions:

• Reposition the probe tip

• Perform otoscopy to check for occlusion

• Remove cerumen from probe tip

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

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

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26 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

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. If an identifiable peak is displayed at 226 Hz, you do not have to repeat the test. 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.

If a leak condition occurs after -300 daPa pressure is reached at 1000 Hz, the PASS, REFER, or RETEST results will be displayed.

Right store/Left store

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

Test results have been stored in the designated memory location. Immediately following this message, the newly-stored tympanogram reappears along with the right or left symbol. For instructions on storing and erasing data, see Chapter 2.

Right clear/Left clear

The designated right or left memory location contains no data. Either no data has been stored or previously stored data has been erased. See Ch. 2 for information on storing and erasing data.

Page 27

Directions for use Understanding the LCD messages 27

Low battery

+200 Vea - cc

1.0

0.5

Ya - mmho

-400 -200 0 200

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. 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.

See Chapter 6, “Maintenance and troubleshooting,” for instructions on removing and recharging the battery.

Range error

The RANGE ERROR message indicates that a large pressure change occurred during a test. If this message appears, press the TEST button and start the test again.

Zero error

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

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 button and start the test again.

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28 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Note

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Calibration due

Welch Allyn recommends annual calibration of your tympanometer to ensure equipment accuracy. The CAL DUE message will display each time the device is powered on when one year has passed since the last calibration. Press and hold the TEST button for approximately two seconds to clear this message and resume patient testing or print information stored in the Handle.

Appropriate charges will apply each time your tympanometer is calibrated.

Needs service

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. Appropriate charges will apply each time your tympanometer is calibrated.

Page 29

Directions for use Understanding the LCD messages 29

Note

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - d aPa

Ya - mmho

+200 Vea - cc

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

System check

The SYS CHK (SYS CHK0, SYS CHK1) message indicates that the Handle is doing a selfcheck to ensure proper operation. The Handle will shut off upon completion of the test. 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.)

After each service, the device must be calibrated. Appropriate charges will apply each time your tympanometer is calibrated.

Data Transfer

When the DATA XFER message displays, the device has made the data connection to the Printer/Charger. Any 226-Hz data stored in the Handle is now available for printing.

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

+200 Vea - cc

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30 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument

Page 31

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). Given appropriate normative values, static admittance (Peak Ya) is a useful indicator of middle ear disease.

Ty mp anometric Gradient (GR) is a measure of the width of the tympanogram reported in decapascals (daPa)

at 50% of static admittance (Peak Ya) or the tympanometric peak. Given appropriate normative values, tympanometric gradient is a good indicator of the presence of middle ear effusion.

Ty mp anometric Peak Pressure (TPP) is the location of the tympanometric peak on the pressure axis. TPP is

reported in decapascals (daPa). TPP indicates if there is pressure behind the eardrum but usually does not indicate middle ear disease.

Equivalent Ear Canal Volume (+200 Vea) is an estimate of the volume of air in front of the probe, measured

in cubic centimeters (cc). A high volume suggests an eardrum perforation or patent tympanostomy tube. Perforations can be present when Vea is normal.

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32 Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Normal static admittance and TPP (Adults)

Normal static admittance and TPP (Children)

Admittance axis

Pressure axis

Gradient (Width) Adult

Gradient (Width) Child

Note

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). A sample of the Liquid Crystal Display appears below.

226-Hz mode

Normative values

The normative values presented in the table below are taken from a study by Margolis and Heller (1987) and from the "Guidelines for Screening for Hearing Impairments and Middle Ear Disorders" (1990).

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 tympanometric values (226 Hz)

Ty mp a nometric Measurement Child's Ear

(Under Age 10) 90% Range

Peak Ya (Positive Tail Compensation)

Gradient (GR) (Tympanometric Width)

Tympanometric Peak Pressure (TPP)

Equivalent Ear Canal Volume (Vea)

0.2 to 0.9 mmho 0.3 to 1.4 mmho

60 to 150 daPa 50 to 110 daPa

-139 to +11 daPa -83 to 0 daPa

0.4 to 1.0 cc 0.6 to 1.5 cc

Adult's Ear (Age 10 & Over) 90% Range

Page 33

Directions for use Interpreting test results 33

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

RIGHT EAR

Note

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

LEFT EAR

Interpreting 226-Hz tympanogram results

Normal middle ear

A tympanogram with normal Peak Ya, gradient (width), and tympanometric peak pressure appears below.

Low admittance tympanograms

Tympanogram with normal Peak Ya and abnormal gradient (width)

Conditions which cause tympanograms with normal height and increased width:

• Otitis media with effusion

• Tympanosclerosis

Low Peak Ya of the middle ear is produced by space-occupying lesions in various ways. A lesion that displaces air in the middle ear space causes low admittance by reducing the middle ear volume. The lesion also may interfere with the vibration of the ossicular chain, contributing to the low admittance. If the lesion is in contact with the eardrum, low admittance is a result of interference with eardrum vibration.

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34 Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

LEFT EAR

Note

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

RIGHT EAR

High Peak Ya

Tympanogram with low Peak Ya

Conditions which cause tympanograms with reduced peak height (low Peak Ya):

• Otitis media with effusion

• Tympanosclerosis

•Cholesteatoma

• Middle ear tumor

See Appendix A for descriptions of low-admittance pathologies: otitis media with effusion, middle ear tumor, ossicular fixation, and otosclerosis.

High admittance tympanograms

Tympanogram with high Peak Ya

Conditions which cause tympanograms with increased peak height (high Peak Ya):

• Tympanic membrane abnormalities

• Ossicular disruption

When peak admittance exceeds 1.5 mmho, data points will be printed at baseline (0.0 mmho), as shown above.

See Appendix A for a description of tympanic membrane abnormalities and ossicular disruption.

Page 35

Directions for use Interpreting test results 35

Note

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

RIGHT EAR

Negative and positive peak pressure tympanograms (left or right shift)

Tympanogram with negative middle ear pressure

LEFT EAR

1.5

1.0

0.5

Ya - mmho

-400 -200 0 200

PRESSURE - daPa

Conditions which cause negative middle ear pressure:

• Eustachian tube dysfunction

•Cold

• Allergies

• Vigorous sniffing

Negative pressure within the middle ear space will produce a tympanogram with a negative tympanometric peak pressure. Some degree of negative pressure is normal. Negative middle ear pressure often accompanies a cold or allergies, or can be a result of eustachian tube dysfunction. Negative middle ear pressure is not usually associated with effusion when peak Ya is normal. Vigorous sniffing may be the most common cause of negative tympanometric peak pressure in children.

Vea

+200

Tympanogram with positive middle ear pressure

Condition which causes positive middle ear pressure:

• Acute otitis media

Positive tympanometric peak pressure tympanograms reflect positive pressure in the middle ear space. A high positive Tympanometric Peak Pressure (TPP) can be indicative of acute otitis media, but only if the tympanometric peak is extremely positive.

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36 Interpreting test results Welch Allyn MicroTymp3 portable tympanometric instrument

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

LEFT EAR

Note

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

LEFT EAR

Flat tympanograms

Flat tympanogram with normal ear canal volume

Condition which causes a flat tympanogram with normal ear canal volume:

• Middle ear effusion

Flat tympanogram with increased ear canal volume

Conditions which cause flat graph and increased ear canal volume:

• Patent tympanostomy tube

• Perforated tympanic membrane

This condition may produce a persistent OPEN message if measured Vea is greater 2.5 cc. See page 24.

Page 37

Directions for use Interpreting test results 37

Note

-400 -200 0 200

0.5

1.0 1

1.5

PRESSURE - daPa

Ya - mmho

Vea

+200

RIGHT EAR

Tympanograms with artifact

Conditions which cause artifact:

• Patient movement

• Practitioner movement

• Vocalizing or crying

During the typanometric measurement, the clinician should keep a steady hand, and the patient should not talk, chew gum, yawn, cry, or move. If the display indicates too much artifact, the clinician must repeat the measurement.

1000-Hz mode

Tympanometry in young infants

Tympanograms obtained with a 226-Hz probe tone have been found to be insensitive to middle ear fluid in young infants. Recent studies using a 1000-Hz probe tone have shown good sensitivity to middle ear disease in this population. Research suggests the age at which 226-Hz tympanometry becomes an appropriate test is between four and six months. An appropriate guideline for selecting the appropriate age-based frequency is to use 1000-Hz tympanometry for infants below four months of age, 226-Hz for infants above six months of age, and both frequencies for infants four to six months of age.

The “Quick-Interpretation” feature of this tympanometer enables clinicians to test infants less than six months old and receive immediate interpretive feedback from the device. The 1000-Hz interpretations are based on proven clinical criteria, including calculated values in the shape of the curve.

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38 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. Audiol., 14, 383-392, 2003.]

Normative tympanometric values (1000 Hz)

Ty mp a nometric MeasurementNICU

90% Range

Peak Ya

0.6 - 2.7 mmho 0.6 - 4.3 mmho

(Negative Tail Compensation)

Tympanometric

-93 - +53 daPa -133 - +113 daPa

Peak Pressure (TPP)

Interpreting 1000-Hz results

Pass

Ya - mmho

A normal tympanogram will yield a PASS result. The displayed numerical value represents the compensated admittance.

1.0

0.5

-400 -200 0 200

PRESSURE - daPa

Full-term 90% Range

+200 Vea - cc

Condition which causes a PASS message:

• Peak Ya greater than or equal to 0.6 mmho

Page 39

Directions for use Interpreting test results 39

Note

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Note

-400 -200 0 200

0.5

1.0

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Refer

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. When the Peak Ya is less than 0.6 mmho, the test is indicative of abnormal middle ear function, most commonly middle ear effusion.

You may choose to retest the patient to confirm a REFER result.

Retest

Certain testing or patient conditions may cause inconclusive results, yielding a RETEST message on the display. You may interpret a series of RETEST results as a REFER result.

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40 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. Altitude can also affect MicroTest Cavity results. See Functional Checks starting on page 55.

Altitude adjustments for Vea readings

Altitude Adjustment

for 0.2 cc

-1200 ft (-366 m) 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc

0 ft (0 m) 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc

1000 ft (305 m) 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc

2000 ft (610 m) 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.0 cc 0.1 cc

3000 ft (914 m) 0.0 cc 0.0 cc 0.1 cc 0.1 cc 0.1 cc 0.1 cc

4000 ft (1219 m) 0.0 cc 0.1 cc 0.1 cc 0.1 cc 0.1 cc 0.1 cc

5000 ft (1524 m) 0.0 cc 0.1 cc 0.1 cc 0.1 cc 0.1 cc *

6000 ft (1829 m) 0.1 cc 0.1 cc 0.1 cc 0.2 cc 0.2 cc *

7000 ft (2134 m) 0.1 cc 0.1 cc 0.1 cc 0.2 cc 0.2 cc *

8000 ft (2438 m) 0.1 cc 0.1 cc 0.2 cc 0.2 cc 0.3 cc *

9000 ft (2743 m) 0.1 cc 0.1 cc 0.2 cc 0.3 cc 0.3 cc *

10000 ft (3048 m) 0.1 cc 0.2 cc 0.2 cc 0.3 cc 0.4 cc *

* The MicroTymp3 will read “OPEN” when used on this ear canal volume at this altitude and will not run a test.

Influence of temperature

Adjustment for 0.5 cc

Adjustment for 1.0 cc

Adjustment for 1.5 cc

Adjustment for 2.0 cc

Adjustment for 2.4 cc

No corrections for temperature are required with this device.

Page 41

Tymp

Micro

Portable Tympanometric Instrument

-400

-200 0

200

0.5

1.0

GR A

GR C

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

-400

-200 0

200

0.5

1.0

GR A

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

Note

Printing 226-Hz results

Print memory contents

Follow the steps listed below to print tympanometric data stored in the Handle:

1. Place the Handle in the well with the Liquid Crystal Display (LCD) and buttons facing you. When the Handle is properly seated in the well, the green CHARGE indicator illuminates.

2. Press the PRINT button.

3. To feed extra paper, press the FEED button. Paper continues to feed as long as the button is depressed.

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 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

printout as illustrated below and to print in manual mode. To change formats or print in automatic mode, follow the instructions on page 45.

• If only one ear has been tested, the memory for the other ear should be

erased (see page 20) 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.

Page 42

42 Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument

Tympanogram section

Data section

Interpretive messages section

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 format of the printout, see page 45.

Tympanogram section

The tympanogram is a graph which records the admittance of the ear as a function of air pressure.

Page 43

Directions for use Printing 226-Hz results 43

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). Given appropriate normative values, static admittance (Peak Ya) is a useful indicator of middle ear disease.

• Tympanometric Gradient (GR) is a measure of the width of the tympanogram reported in decapascals (daPa) at 50% of static admittance (Peak Ya) or the tympanometric peak. Given appropriate normative values, tympanometric gradient is a good indicator of the presence of middle ear effusion.

• Tympanometric Peak Pressure (TPP) is the location of the tympanometric peak on the pressure axis. TPP is reported in decapascals (daPa). TPP indicates if there is pressure behind the eardrum but usually does not indicate middle ear disease.

• Equivalent Ear Canal Volume (+200 Vea) is an estimate of the volume of air in front of the probe, measured in cubic centimeters (cc). A high volume suggests an eardrum perforation or patent tympanostomy tube. Perforations can be present when Vea is normal.

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 the table on page 32.

For the following tympanometric results, no data will be printed:

• 1000-Hz results

• Peak Ya is greater than 1.5 mmho. The message "High Peak Ya" will appear at the top of the tympanogram.

• Peak Ya less than 0.3 mmho.

• 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.

Interpretive messages section

The interpretive messages section of the printout provides an interpretive, verbal description of the tympanometric result.

The computer in the Printer/Charger examines the data for clinically-significant deviations from the normal values. For example, a tympanogram which is too wide may be indicative of a developing or resolving otitis media; the message reads "Tympanogram Is Wide.”

The hierarchy of messages displayed is as follows:

Noisy Tympanogram

Low Peak Height, Small Ear Volume

Low Peak Height, Normal Ear Volume

Page 44

44 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.

Select printout formats

The four switches used to select the printout format and printer mode of operation are located on the bottom of the Printer/Charger.

Use a pointed object to depress appropriate ON or OFF portion of the switch.

Page 45

Directions for use Printing 226-Hz results 45

1234

OFF

Note

Tympanogram Only (Switch 3)

Tympanogram and Data (Switch 3)

Messages

(Switch 2)

No messages (Switch 2)

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.

1234

OFF

This causes the printout to begin automatically once the Handle is placed in the well, and data transfer is complete.

Manual Print

In the manual mode, a beep will occur as a reminder that data has been transmitted; however, it is not necessary to wait for the beep before pressing the PRINT button.

Change printout format

Use Switches #2 and #3, located on the bottom of the Printer/Charger, to change printout format. Printout options are shown below.

Depress the OFF portion of the switch to select this option. This causes the printout to begin only when the PRINT button is depressed.

1234

OFF

1234

OFF

1234

OFF

1234

OFF

Page 46

46 Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument

OFF

1234

OFF

1234

OFF

1234

OFF

1234

OFF

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.

Refer to the Printout formats section on page 42 for more information on these messages.

Messages

Depress the OFF portion of the switch to select this option. This causes the messages which interpret the tympanograms to be included on the printout.

Print tympanogram only or tympanogram and data (Switch #3)

Tympanogram only

Depress the ON portion of the switch to select this option. Only the tympanogram and the GR (Width) numeric value will print.

Tympanogram and data

Manufacturing switch (Switch #4)

Depress the OFF portion of the switch to select this option. Both the tympanogram and its corresponding numeric data will print.

This switch is used during manufacturing only. Leave this switch in the OFF position. The Printer/Charger will not operate normally if this switch is on.

Page 47

Directions for use Printing 226-Hz results 47

Note

Printer function messages

If tympanometric results are not printed, a message will appear describing the reason. These messages are listed in the table below.

Printer messages

Printer function message Possible cause Possible solution

No Data Reinsert Handle

The Handle is not located in the well. Seat the Handle in the well.

The Handle is not seated properly in the well.

The Handle has a discharged or missing battery.

The Handle is not functioning properly. Call your nearest Welch Allyn service

Ensure that the Handle is fully seated in the well with the Liquid Crystal Display (LCD) and buttons facing you.

Verify battery is in place and charged (LOW BATT messaged does not appear).

location, distributor, or factory representative.

No Data Nothing in Memory

Computer Interface Switch 4 is Set on Bottom of Printer

Printer service codes

When the Printer/Charger is plugged into an electrical outlet, the green POWER indicator illuminates and the instrument beeps to indicate that the printer is ready for use.

If a problem exists, the green POWER indicator flashes. The number of flashes corresponds to the specific problems listed in the table below.

Printer/Charger flashing indicators

Number of flashes Problem Solution

One Printer/Charge is out of paper Replace paper.

Two Paper lever is in wrong (forward) position. Return paper to its original, correct position.

Three or More System failure within Printer/Charger. Verify that switch #4 is in the OFF position.

Both right and left memory locations in the Handle are empty or data stored is in “Quick-Interpretation” (1000-Hz) mode.

Switch #4 on the Printer/Charger is ON. Turn off Switch #4.

Ensure that data is being stored correctly.

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.

If the green POWER indicator is not illuminated, verify connection to live power source. If the problem persists, return the Printer/Charger to the nearest Welch Allyn service location.

Page 48

48 Printing 226-Hz results Welch Allyn MicroTymp3 portable tympanometric instrument

Page 49

Note

Maintenance and troubleshooting

Maintain the equipment

About the battery

The rechargeable Lithium-ion battery is intended for many charge/discharge cycles and is warranted for two years. The warranty expiration date is imprinted on the battery.

Caution Replace battery with Welch Allyn model #72910 battery only.

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:

1. Allow the Handle to power down.

2. Unscrew the battery cover in a counterclockwise direction using the #1 Phillips head screwdriver provided. Save the screw.

3. Remove the battery cover by lifting the bottom of the cover away from the probe tip.

Page 50

50 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument

Note

72910

REF

72910

REF

Lithium

Ion

72910

REF

Lithium

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. Push the battery lightly to compress the contact, and lower the battery into the compartment.

Insert the battery only as shown. Failure to observe the correct polarity will prevent the instrument from functioning.

6. Replace the cover by inserting the tip end under the front cover, lowering the opposite end, and replacing the screw.

Page 51

Directions for use Maintenance and troubleshooting 51

Note

Micr

oTymp

t a

ble

T ym

pan

me tri

c In

u m

e nt

0297

IEC TYPE 3 Skaneateles Falls, NY USA

US Pat #5,383,097

ANSI TYPE 4

Patent Pending

74227

23650

REF

Note

7. 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.

Recharge the battery

To recharge the battery, place the Handle in the Printer/Charger well with the LCD and buttons facing you.

Caution To prevent equipment damage, charge the Handle only with the Printer/Charger (#7117x).

The 3.7V Lithium-ion battery used in the Handle, when fully charged, provides a full day of operation without the need for recharging and yields a minimum of 300 double-ear tests. This makes the instrument optimal for mass screening or off-site situations where there may not be a need to print, but there is a need for continuous operation.

A fully drained battery should be recharged overnight (16 hours).

• The Handle may be charged indefinitely without damage to the battery.

• Slight heating of the Handle during charging is normal.

• The battery will self-discharge gradually over a period of approximately 60

days when stored at room temperature (70°F/21°C); storage at higher temperatures accelerates the discharge rate.

Page 52

52 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument

Note

Recycle the Battery

Check with your local waste management agency for the proper recycling procedure for a Lithium-ion battery.

Lithium-ion battery. Must be recycled or disposed of properly.

Replace the tips

Replace the probe tips after six months of use.

Replace the paper

The Printer/Charger signals the need for changing the paper in one of two ways:

• A pink strip appears along the edge of the paper indicating the paper is nearing the end of the roll.

• The POWER indicator flashes in single pulses indicating that there is no paper, and no printing can occur.

• Use only an appropriate heat-sensitive paper or the Printer/Charger life may

be shortened and the warranty voided.

• The paper is thermally activated, so it must be stored in a cool, dark location

to prevent exposure and degraded performance.

• Because the paper is thermally activated, no printing will appear on the paper

if it is inserted backwards.

• Do not use transparent adhesive tape on printed portions of the printout, as

those portions will then fade.

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.

1. Remove the paper access cover by pulling up on the front edge.

Page 53

Directions for use Maintenance and troubleshooting 53

Note

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. Pull the paper lever forward.

4. Place the roll of paper behind the Printer/Charger for easier handling.

5. Insert the paper (from of the bottom of the roll) into the slot under the pinch roller, making sure that the paper is centered.

6. Return the paper lever to its original position, and press the FEED button to advance several inches of paper beyond the pinch roller.

7. Tighten the paper on the paper roll, reinsert the black spindle through the roll, and place the paper roll in the paper cradle.

8. Feed the paper through the slot in the paper access cover.

Make sure that the paper is taut before replacing the paper access cover. Loose paper can cause printer malfunction.

9. Replace the cover by sliding the back edge into place first and lowering the front of the paper access cover.

Page 54

54 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.

Clean the printer/charger

Clean the Printer/Charger by wiping it with a cloth that has been lightly dampened with 70% Isopropyl alcohol. Make sure liquid does not seep into either the printer area or the charging well.

Clean the probe tips

After each use, inspect small openings in the tip for debris, then remove tip from Handle. If you observe no debris, wipe with a clean cloth and a 70% isopropyl alcohol solution. Allow to air dry.

If you observe debris after use, rinse tip with warm tap water for one minute, then soak the tip in 70% alcohol for 20 minutes. Rinse tip with tap water and air dry.

Page 55

Directions for use Maintenance and troubleshooting 55

Note

roTest

VITY

2.0

-400

-200

200

0.5

PRE

DaPa

Ya -

TEST button

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). The 2.0 cc cavity is used to test the High Range of the ear canal volume (Vea).

Check the Handle with the MicroTest Cavity at least once a month and whenever the operation of the Handle is questioned.

Functional testing must be done in both the 226-Hz mode and the 1000-Hz mode.

226-Hz check

To switch the frequency, simultaneously press and .

After completing both tests, you can toggle back to desired frequency by pressing the same buttons.

1. Make sure the Handle is in 226-Hz mode.

2. Using any size probe tip, place the probe tip against the 0.5 cc cavity as if it were an ear. Hold the handle and MicroTest Cavity carefully to prevent movement. Depress the TEST button and test the cavity as you would an ear.

3. Store the information using either the right or left memory buttons.

4. Repeat Steps 2 and 3 using the 2.0 cc cavity. Store the information in the opposite memory location used in Step 2.

5. Print the information using the Printer/Charger.

Page 56

56 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument

Ty mp a nogram from 0.5 cc cavity

Note

A properly functioning instrument will produce two results:

• A flat tympanogram (see the figure below). All data points must fall within the two bottom rows of the graph.

• An ear canal volume (Vea) which corresponds to the cavity tested. See the Expected Vea readings table for the acceptable range for each cavity both at sea level and at different altitudes.

1000-Hz check

Expected Vea readings for MicroTest cavity

Cavity Measured Acceptable

Tol erances

0.5 cc Cavity ±0.1 cc 0.4 cc to 0.6 cc 0.4 cc to 0.6 cc 0.5 cc to 0.7 cc

2.0 cc Cavity

Refer to the Influence of altitude table on page 40 for a more comprehensive treatment of altitude’s effect.

±0.1 cc 1.9 cc to 2.1 cc 2.0 cc to 2.2 cc 2.0 cc to 2.2 cc

Acceptable Range at Sea Level

Acceptable Range at 3000 ft (914 m)

Acceptable Range at 5000 ft (1524 m)

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. Therefore, at altitudes above sea level, results using the MicroTest Cavity will change.

1. Make sure the Handle is in 1000-Hz mode.

3. Store the information using either the right or left memory buttons.

4. Repeat Steps 2 and 3 using the 2.0 cc cavity. Store the information in the opposite memory location used in Step 2.

The Handle should display REFER 0.4 or less in both the 0.5 cc and 2.0 cc cavities.

While the MicroTest Cavity provides a functional test, it does not replace full calibration. Welch Allyn recommends that the Handle be calibrated annually.

Page 57

Directions for use Maintenance and troubleshooting 57

1 Test Pattern

2 Software Version

3 Normative Data Reference

Troubleshooting the Handle

Symptom Possible Cause Possible Solution

Handle does not turn on No battery. Put battery in. Reset the battery protection circuit.

Battery is in backwards. Reposition the battery observing correct polarity. Reset

the battery protection circuit.

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 not reset.

Too much artifact on LCD Too much movement during

test.

Handle has too much internal noise.

Place the Handle in the Printer/Charger for a minimum of 10 seconds to reset the battery protection circuit.

See page 37.

Check handle in MicroTest cavity. If handle passes functional check, artifact is due to motion. If handle does not pass functional check, return to Welch Allyn service location for service.

“Frozen” display on LCD

“Checkerboard” pattern on LCD

Check the printer/charger

Pressing the FEED and PRINT buttons simultaneously causes a test pattern to print, as shown below.

Microcomputer has malfunctioned.

Push TEST and repeat. If symptom persists, push all three handle buttons (TEST, R MEM, L MEM) simultaneously to reset microcomputer. If symptom persists, remove and reinsert the battery. If symptom persists, return to local Welch Allyn service location for service.

Page 58

58 Maintenance and troubleshooting Welch Allyn MicroTymp3 portable tympanometric instrument

1. 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. A defect in the paper may also cause white lines or light printing. Repeat the test pattern to confirm any suspected printing problems. If paper advances but nothing prints out, check to be sure the paper is inserted properly (see

page 52).

2. Software Version - The test pattern also includes the software version for the Printer/ Charger.

3. Normative Data Reference - The test pattern is followed by normative data for tympanometric characteristics for both the MicroTymp2 and MicroTymp3 Handle. This is provided along with the test pattern for the convenience of the user, not specifically as a functional check.

Page 59

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). In intermediate stages of OME, the peak height may be normal, but the gradient may be widened.

Middle ear tumor

A wide variety of neoplastic processes exist that invade the middle ear. The most common is the keratoma (cholesteatoma), a collection of keratinizing squamous epithelium that frequently originates from Shrapnel's membrane (pars flaccida) of the tympanic membrane or the ear canal wall and invades the middle ear space. Other middle ear tumors include the cholesterol granuloma, glomus tumor, and squamous cell carcinoma. These pathologies generally result in a flat tympanogram.

Lateral ossicular fixation

Lateral ossicular fixation may result from tympanosclerosis, a complication of chronic otitis media that may involve the eardrum, malleus, incus, and/or stapes. In general, the more lateral the fixation, the more effect the condition has on the tympanogram. Lateral fixations typically cause low Peak Ya and wide tympanometric widths.

Otosclerosis

Because the otosclerotic lesion is more medial than lateral ossicular fixation, the tympanogram is less affected. The tympanometric shape is often indistinguishable from normal, although the Peak Ya may be slightly low and the tympanometric gradient (width) may be narrower than the normal tympanogram.

Tympanic membrane abnormalities

The tympanic membrane is normally a stiff, conically-shaped structure that derives its stiff characteristic from the lamina propria, a layer of connective tissue that is situated between the outer layer of squamous epithelium (skin) and the inner layer of mucous membrane. When the eardrum heals after a relatively large perforation, the lamina propria may be absent or thin in the region of the scar. This neomembrane can be set into

Page 60

60 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.

Ossicular disruption

Disruption of the ossicular chain can range from partial interruption to complete absence of the ossicles. These conditions result from the erosive effects of chronic infection, trauma, and congenital defect. Ossicular disruption is usually associated with a substantial conductive hearing loss. Because the ossicles normally "load" the eardrum, contributing to its tension, the eardrum in an ear with ossicular disruption can be more easily set into vibration than the normal eardrum, resulting in high Peak Ya.

Page 61

Service

Repair

Calibration

Service and warranty information

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.

Welch Allyn recommends that the Handle be calibrated annually. Arrangements may be made by returning the registration card or by contacting Welch Allyn's Technical Service Department or an authorized Welch Allyn distributor. A moderate fee is charged for calibration.

A monthly functional check using the MicroTest Cavity is recommended in addition to annual calibration.

The Printer/Charger does not require calibration.

Page 62

62 Service and warranty information Welch Allyn MicroTymp3 portable tympanometric instrument

Note

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 component thereof is found to be defective or at variance from the manufacturer's specifications during the warranty period, Welch Allyn will repair, replace or calibrate the instrument or component(s) at no cost to the purchaser.

This warranty only applies to instruments purchased new from Welch Allyn or its authorized distributors or representatives. The purchaser must return the instrument directly to Welch Allyn or an authorized distributor or representative. Ground shipping charge to return a defective device to the nearest Welch Allyn center is included.

This warranty does not cover breakage or failure due to tampering, misuse, neglect, accidents, modification or shipping, and is void if the instrument is not used in accordance with manufacturer's recommendations or if repaired or serviced by other than Welch Allyn or a Welch Allyn authorized representative.

Purchase date determines warranty and annual calibration requirements. No other express or implied warranty is given.

Proof of purchase date is required for warranty validation.

Rechargeable battery

Welch Allyn Lithium-ion batteries are warranted by Welch Allyn for two years from date of manufacture (when used in Welch Allyn instruments only). Defective batteries under warranty will be replaced when the unit is sent to Welch Allyn for service.

Page 63

3.68 in

9.35 cm

7.32 in

18.6 cm

1.94 in

4.94 cm

9.62 in

24.4 cm

9.70 in

24.6 cm

4.82 in

12.2 cm

POWER

CHARGE FEED PRINT

TEST

-400 -200 0 200

0.5

1.0

GR A

GR C

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

MicroTymp

Portable Tympanometric Instrument

0297

IEC TYPE 3 Skaneateles Falls, NY USA

US Pat #5,383,097

ANSI TYPE 4

Patent Pending

74227

23650

REF

Specifications

Physical characteristics

Page 64

64 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.

Pressure measurement system

Direction of sweep: positive to negative pressure

Sweep Rate: 400 daPa/sec average during data acquisition period

Range: +200 to -400 daPa

Display resolution: 20 daPa

Accuracy: ±15% or ±10 daPa, whichever is greater

Compensation: Auto-zero every test cycle

Admittance measurement system

226-Hz mode

Range: 0.2 to 4.0 mmho total

0.0 to 1.5 mmho for Ya

0.2 to 2.5 cc for +200 Vea

Accuracy: ±0.1 mmho or ±5%, whichever is greater

Positive tail compensation

1000-Hz mode

(applies only at sea level)

Range: 0.9 to 16.6 mmho total

0.0 to 6.5 mmho for Ya (for ear canal volumes 2.0 cc)

0.2 to 2.5 cc for +200 Vea

Accuracy: ± 0.4 mmho or ± 5%, whichever is greater

Negative tail compensation

Page 65

Directions for use Specifications 65

Note

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

No warm-up period is required if the instrument is stored in conditions consistent with the operating environment.

Storage environment

Temperature: -20°C to +49°C

Relative Humidity: 15% to 95%

Units must be stored in conditions consistent with the defined operating environment for a period of 24 hours prior to use.

Battery

3.7 V Lithium-ion rechargeable, 800 mAh capacity

All specifications are met over a battery voltage range of 3.1V to 4.2V.

Probe tips

Five color-coded sizes: Extra Small, Small, Medium, Large, Extra Large

Tip outer diameter dimensions

Tip Size Diameter (in.) Diameter (mm)

Extra Small 0.30 in. 7 mm

Small 0.37 in. 9 mm

Medium 0.48 in. 12 mm

Large 0.62 in. 16 mm

Extra Large 0.79 in. 20 mm

Page 66

66 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument

Printer paper

4.42 in. (112 mm) wide with core

Printer/Chargers

Printer/Charger models

Welch Allyn Model Number

71170 120 V~, 1A Canada, Japan, United States

71172 230 V~, 1A Europe

71174 230 V~, 1A United Kingdom

71176 230 v~, 1A Australia, New Zealand

Operating ranges

Nominal Output Major Geographic Areas Plug Type

Input voltage for all Printer/Charger models is 100 to 240 V~

Input frequency for all Printer/Charger models is 50 to 60 Hz

Input current is 1A maximum

Equivalent units and symbols

Acoustic Admittance: mmho = 10-8m3/Pa*s

Air Pressure: daPa = Air Pressure (daPa) (1 daPa = 1.02 mmH2O)

Equivalent Volume = V

Pressure on LCD/printout = Relative Pressure = ps

Pressure on LCD/printout = pressure - daPa = Air Pressure (daPa) (1 daPa = 1.02 mmH2O)

Admittance on LCD/Printout = Ya - mmho = Acoustic Admittance (acoustic mmho)

= +200 Vea

Page 67

Directions for use Specifications 67

Standards compliance

This instrument complies with the following standards based on the most recent revision available at the time of design:

UL 60601-1

CAN/CSA C22.2 No. 601.1-M90

EN/IEC 60601-1:1990

EN/IEC 60601-1-2

ANSI S3.39-1987 - ANSI Type 4 instrument

IEC 60645-5: 2004 - IEC Type 3 Instrument

Handle: 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

Disposal of non-contaminated electrical and electronic equipment Directive 2002/96/EC-WEEE

Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply.

For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.

Page 68

68 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.

Electromagnetic Emissions

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.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Group 1 The MicroTymp3 uses RF energy only for its internal function. Therefore, its RF

emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B The MicroTymp3 is suitable for use in all establishments, including domestic

establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Class A

Complies

Page 69

Directions for use Specifications 69

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

Test Level

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/ burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines.

IEC 61000-4-11

Power frequency (50/60Hz) magnetic field

± 6 kV contact

± 8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

>95% dip in 0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

>95% dip in 5 seconds

3 A/m 3 A/m Power frequency magnetic fields should be at levels

Compliance Level Electromagnetic Environment - Guidance

± 6 kV contact

± 8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

>95% dip in 0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

>95% dip in 5 seconds

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the MicroTymp3 requires continued operation during power mains interruptions, it is recommended that the MicroTymp3 be powered from an uninterruptible power supply or battery.

Note: “Dip” refers to a dip in mains voltage.

characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8

Page 70

70 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument

PPP

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

Test Level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance

Electromagnetic Environment - Guidance

Level

Portable and mobile RF communications equipment should be used no closer to any part of the MicroTymp3, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

V1 = 3 Vrms d = (1.17)

E1 = 3 V/m d = (1.17) 80 MHz to 800 MHz

d = (2.33) 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, each frequency range.

should be less than the compliance level in

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MicroTymp3 is used exceeds the applicable RF compliance level above, the MicroTymp3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MicroTymp3.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Page 71

Directions for use Specifications 71

PPP

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.

Separation Distance According to Frequency of Transmitter (m)

Rated Max. Output

Power of Transmitter

(W)

0.01 0.11667 0.11667 0.23333

0.1 0.36894 0.36894 0.73785

1 1.1667 1.1667 2.3333

10 3.6894 3.6894 7.3785

100 11.667 11.667 23.3333

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

150 kHz to 80 MHz

d = (1.17)

80 MHz to 800 MHz

d = (1.17)

800 MHz to 2.5 GHz

d = (2.33)

Page 72

72 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument

Page 73

Note

2.0 cc

0.5 cc

MicroT est

CA VITY

72910

REF

Lithium

Ion

Replacement parts and accessories

Items are not drawn to scale.

Battery

#72910 3.7 V Lithium-ion

Screw for Battery Cover

#236081

Screw Driver for Battery Cover

#236200-2

MicroTest Cavity

#711772-501

Probe Tips - Four of the selected size in a bag

#24621

Black

Extra Small

#24622

Gray

Small

#24623

Blue

Medium

#24624

Green

Large

#24625

White

Extra Large

Box with two sets of tips

#24620

MicroTymp 2 and 3 Paper

#56100

Spindle for Paper

#761050-1

Card Holder

#55260

Page 74

74 Replacement parts and accessories Welch Allyn MicroTymp3 portable tympanometric instrument

#761076-0

120 V

Canada, Japan,

U.S.

#761076-4

230 V

United Kingdom

#761076-6

230 V

Australia,

New Zealand

#761076-2

230 V

Europe

TEST

-400 -200 0 200

0.5

1.0

GR A

GR C

PRESSURE - daPa

Ya - mmho

+200 Vea - cc

MicroTymp

Portable Tympanometric Instrument

0297

IEC TYPE 3 Skaneateles Falls, NY USA

US Pat #5,383,097

ANSI TYPE 4

Patent Pending

74227

23650

REF

1000-Hz Screening Results Cards - Quantity 100: four packs of 25

#55270

Replacement Power Cords (order by plug type)

Handle

#23650

Carrying Case for MicroTymp 2 or 3 and AudioScope 3

#05276-U

Page 75

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

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).

keratoma A collection of keratinizing squamous epithelium that invades the middle ear;

keratoma frequently originates from a perforation in Shrapnell’s membrane (pars flaccida) of the tympanic membrane; also called cholesteatoma.

lateral ossicular fixation Fixation of the malleus and/or incus, frequently caused by

tympanosclerosis, a complication of chronic otitis media.

middle ear effusion An accumulation of fluid (liquid) in the middle ear.

neomembrane A scar on the tympanic membrane; the scarred region may be thinner

and have a higher admittance than the normal tympanic membrane; also called monomere.

-8m3

/Pa*s.

otalgia Ear ache or pain.

otitis media with effusion Inflammation of the middle ear, often accompanied by an

accumulation of fluid (liquid).

otorrhea External ear discharge.

otosclerosis A genetic abnormality of the temporal bone, frequently causing fixation of

the stapes and conductive hearing loss.

sound pressure The average (rms) difference between the air pressure that occurs

during sound transmission and the ambient air pressure.

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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.

tympanometric gradient A measure of the width of the tympanogram reported in

decapascals (daPa) at 50% of static admittance (Peak Ya) or the tympanometric peak.

tympanometric peak pressure The location of the tympanometric peak on the pressure

axis. TPP is reported in decapascals (daPa).

tympanometry The measurement of acoustic admittance in the sealed ear canal as a

function of ear canal air pressure.

tympanosclerosis A complication of otitis media that is characterized by sclerotic

regions involving the tympanic membrane, ossicles, and middle ear mucosa. Tympanosclerosis increases the stiffness of the middle ear system.

volume velocity The volume of air that passes through a plane per unit time.