MADSEN OTOflex 100 & OTOsuite User Manual Rev 12 June 2010

Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module User Manual 1

Introduction... 11 1.1 MADSEN OTOflex 100... 11 1.2 OTOsuite and the Immittance Module... 11 1.2.1 The flexibility of the OTOsuite Immittance Module... 12 1.3 Intended use... 12 1.3.1 MADSEN OTOflex 100... 12 1.3.2 The Immittance Module... 13 1.4 About this manual... 13 1.4.1 Safety... 13 1.4.2 Installation... 13 1.4.3 Descriptions and testing... 14 1.4.4 Preparing for testing... 14 1.4.5 Printing... 14 1.4.6 Maintenance and cleaning... 14 1.5 Typographical conventions... 14 1.5.1 Navigation... 14

2

Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module... 17 2.1 Unpacking... 17 2.2 Installation... 17 2.3 Starting up OTOflex 100... 17 2.3.1 Language setting... 18 2.4 Starting up the Immittance Module... 19 2.5 Immittance Module features... 19

3

OTOflex 100 views and main description... 21 3.1 Handling and switching on OTOflex 100... 21 3.1.1 Keypad main functions... 21 3.1.2 The display - test mode... 24 3.2 Controls and menu selections... 25 3.2.1 The Menu... 25 3.2.2 Test Selector mode... 27 3.2.3 The Text Editor... 29 3.2.4 The Tympanometric Curve Selector... 30 3.2.5 The OTOflex 100 Menu... 30

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

4

Navigating in the OTOsuite Immittance Module... 33 4.1 The Immittance Module menu system and toolbar... 4.1.1 Edit menu... 4.1.2 Measurement menu... 4.1.3 Tools menu... 4.1.4 Additional icons... 4.2 The Immittance Module Control Panel... 4.2.1 Sequence selection... 4.2.2 Test control buttons... 4.2.3 Changing Control Panel settings... 4.3 The Tympanometry screen... 4.4 The Acoustic Reflex screens... 4.4.1 The Reflex Screening screen... 4.4.2 The Reflex Threshold screen... 4.4.3 The Reflex Decay screen... 4.5 The ETF-P screen... 4.5.1 The post-analysis tool...

5

Test Device Management in OTOsuite... 45 5.1 Setting up communication with the test device... 5.1.1 Selecting test devices... 5.1.2 Connection... 5.1.3 Connecting to a test device... 5.1.4 Reconnecting to a test device... 5.1.5 Test device information... 5.1.6 Firmware upgrade - test devices...

6

45 45 46 46 46 46 46

Preparing OTOflex 100 and the Immittance Module for testing... 49 6.1 Preparing the test environment... 6.1.1 The test environment... 6.2 Hygienic precautions... 6.3 Preparing OTOflex 100... 6.3.1 Preparing the probe... 6.3.2 Using cap and/or handgrip... 6.3.3 Probe check... 6.3.4 Selecting patient folder and test type in OTOflex 100... 6.3.5 Test flow setup... 6.3.6 Users... 6.4 Preparing the patient... 6.4.1 Fitting the eartip on the probe... 6.4.2 Fitting the probe in the patient’s ear... 6.4.3 Leakage... 6.5 Preparing for the next patient...

4

33 34 34 34 35 35 36 36 37 37 38 39 40 42 43 43

49 49 50 50 50 51 57 58 59 60 61 61 62 64 64

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

7

Testing with MADSEN OTOflex 100... 67 7.1 7.2 7.3 7.4

Fast diagnostics - the quick approach... General test softkeys and shortcuts... Start testing... Sequence testing... 7.4.1 Selecting a test sequence... 7.4.2 Running a test sequence from OTOflex 100... 7.5 Screening... 7.5.1 Screening tympanometry... 7.5.2 Reflex screening... 7.5.3 Settings - Screening... 7.6 Tympanometry... 7.6.1 Tympanometry softkeys and shortcuts... 7.6.2 Diagnostic tympanometry... 7.6.3 The diagnostic tympanometry result... 7.6.4 Settings - Diagnostic tympanometry... 7.7 ETF-I (Eustachian Tube Function - Intact)... 7.7.1 Settings - ETF-I... 7.8 Acoustic reflex testing... 7.9 Reflex Threshold testing... 7.9.1 Keys and functions... 7.9.2 Automatic and semi-automatic Reflex Threshold testing... 7.9.3 Viewing Reflex threshold results... 7.9.4 Settings - Automatic and semi-automatic Reflex Threshold... 7.9.5 Manual Reflex Threshold testing... 7.9.6 The Reflex Threshold results... 7.9.7 Manually selecting/deselecting Reflex Threshold values... 7.10 Reflex Decay testing... 7.10.1 Keys and functions... 7.10.2 Automatic Reflex Decay testing... 7.10.3 Settings - Automatic Reflex Decay... 7.10.4 The Reflex Decay results... 7.10.5 Manual Reflex Decay... 7.11 ETF-P testing (Eustachian Tube Function - Perforated)... 7.11.1 Idle mode functions... 7.11.2 Pressure build functions... 7.11.3 The test... 7.11.4 The ETF-P result... 7.11.5 The Immittance Module post-analysis tool - ETF-P...

8

Managing Test Results in OTOflex 100... 101 8.1 When testing is done... 8.2 Swap ear results... 8.3 Delete measurements... 8.3.1 Tympanometry...

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67 68 69 69 69 70 70 71 71 74 75 76 76 78 80 80 80 81 82 83 84 86 87 88 89 89 90 91 92 93 94 95 97 97 97 98 99 99

101 101 101 101

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

8.3.2 Reflex Threshold... 8.4 Deleting Test Results... 8.5 Communicating and synchronizing with OTOsuite... 8.5.1 Synchronizing data... 8.5.2 Synchronization of corrections made to Patient Folders...

9

101 102 102 103 103

Printing... 105

10 Testing with the OTOsuite Immittance Module... 107 10.1 Sequence testing... 10.1.1 Selecting a test sequence... 10.1.2 T + RS (Tympanometry + Reflex Screening)... 10.1.3 T + RT (Tympanometry + Reflex Thresholds)... 10.1.4 T + RT + RD (Tympanometry + Reflex Threshold + Reflex Decay)... 10.1.5 Running a test sequence from the Immittance Module... 10.2 Screening... 10.2.1 Screening tympanometry... 10.2.2 Acoustic Reflex Screening... 10.3 Tympanometric testing... 10.3.1 Diagnostic tympanometry... 10.3.2 ETF-I, Eustachian Tube Function - Intact... 10.4 Acoustic Reflex Threshold testing... 10.4.1 Automatic and semiautomatic threshold testing... 10.4.2 Manual threshold testing... 10.5 Acoustic Reflex Decay testing... 10.5.1 Automatic Acoustic Reflex Decay testing... 10.5.2 Manual Acoustic Reflex Decay testing... 10.6 ETF-P (Eustachian Tube Function - Perforated)... 10.7 Managing test results... 10.7.1 Tests and subtests... 10.7.2 Swapping ear data... 10.7.3 Deleting data... 10.8 Leakage... 10.9 Testing the other ear... 10.10Saving measurements... 10.10.1 Standards used in NOAH... 10.11Preparing for the next patient...

107 107 107 108 108 108 109 109 110 112 112 114 114 115 119 121 122 123 125 126 126 126 127 127 128 128 128 129

11 Data management in MADSEN OTOflex 100... 131 11.1 Data handling... 11.1.1 Interruption of communication... 11.1.2 Synchronization... 11.2 Uploading test results to OTOsuite... 11.3 Data clean-up...

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131 131 131 132 133

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

12 Immittance test setup in MADSEN OTOflex 100... 135 12.1 Test settings... 12.1.1 Changing individual settings... 12.1.2 Uploading test settings to the Immittance Module... 12.1.3 Creating a setup... 12.1.4 Editing a test setup... 12.1.5 Using a test setup... 12.2 General actions... 12.2.1 Manage test results... 12.2.2 Procedure options... 12.2.3 Advanced... 12.2.4 Device settings... 12.3 Tympanometry setup... 12.3.1 Screening tympanometry... 12.3.2 ETF-I setup... 12.4 Acoustic Reflex Screening setup... 12.5 Acoustic Reflex Threshold setup... 12.6 Acoustic Reflex Decay setup... 12.7 ETF-P setup... 12.8 Test sequences... 12.8.1 Selecting a sequence setup...

135 135 137 138 138 138 139 139 141 144 145 148 152 152 153 156 163 165 166 167

13 Immittance Module Tools Options (view and measurement options)... 169 13.1 General settings... 13.1.1 Available settings... 13.2 View settings... 13.2.1 Tymp. and Reflex Scr. view settings... 13.2.2 Reflex Threshold view settings... 13.2.3 Reflex Decay view settings... 13.2.4 ETF-P view settings... 13.3 Measurement settings... 13.3.1 Tympanometry setup... 13.3.2 ETF-I Setup... 13.3.3 Acoustic Reflex Screening setup... 13.3.4 Acoustic Reflex Threshold setup... 13.3.5 Reflex Decay setup... 13.3.6 ETF-P setup...

169 169 171 171 174 175 175 175 176 179 179 181 186 189

14 OTOflex 100 Service and Maintenance... 191 14.1 Equipment failure... 14.2 Service and repair... 14.3 Maintenance... 14.3.1 Calibration...

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191 191 191 192

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

14.3.2 Probe cleaning and maintenance... 14.4 Cleaning and disinfecting the probe tip... 14.4.1 Changing the wax filter... 14.5 Cleaning OTOflex 100... 14.5.1 Eartips... 14.5.2 Disposal of disposable articles... 14.5.3 Batteries and charger... 14.5.4 Safety information... 14.5.5 Environmental protection...

192 193 195 195 196 196 196 197 198

15 Installing MADSEN OTOflex 100... 199 15.1 Unpacking OTOflex 100... 15.2 Storing OTOflex 100... 15.3 Views of OTOflex 100... 15.3.1 Front view... 15.3.2 Top view... 15.3.3 Bottom view... 15.3.4 Reverse side view... 15.3.5 The charger... 15.4 The probe... 15.5 Assembly and installation... 15.5.1 Location... 15.5.2 Desktop installation... 15.5.3 Wall mount installation... 15.6 Powering... 15.6.1 Powering OTOflex 100... 15.6.2 Batteries... 15.6.3 The charger... 15.6.4 Switching on OTOflex 100... 15.6.5 Bluetooth...

199 199 199 200 200 201 201 201 202 202 202 203 204 206 206 206 209 210 210

16 Configuring OTOsuite... 213 App. 1

Standards and safety - OTOflex 100 and  the Immittance Module... 215 App. 1.1 Symbols used... App. 1.1.1 OTOflex 100 symbols... App. 1.1.2 Charger unit symbols... App. 1.1.3 The OTOsuite Audiometry Module... App. 1.2 Warning notes... App. 1.2.1 OTOflex 100 warning notes... App. 1.2.2 Charger unit warning notes... App. 1.3 Manufacturer... App. 1.3.1 Responsibility of the manufacturer...

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215 215 216 217 217 217 219 219 219

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

App. 2

MADSEN OTOflex 100 Immittance Methodology and Features... 221 App. 2.1 An introduction to immittance... App. 2.1.1 Immittance testing... App. 2.2 Tympanometry... App. 2.2.1 Tympanometry testing on infants... App. 2.2.2 Tympanometric features... App. 2.2.3 ETF-I (Eustachian Tube Function - Intact)... App. 2.2.4 Valsalva’s Maneuver... App. 2.2.5 Toynbee’s Maneuver... App. 2.3 Acoustic Reflex testing... App. 2.3.1 Acoustic Reflex Screening... App. 2.3.2 Acoustic Reflex Threshold... App. 2.3.3 Acoustic reflex decay... App. 2.3.4 Admittance monitoring... App. 2.4 ETF-P (Eustachian Tube Function - Perforated)... App. 2.5 Susceptance and Conductance, B/G... App. 2.5.1 Susceptance, B... App. 2.5.2 Conductance, G... App. 2.5.3 B/G viewing of tympanograms... App. 2.5.4 Component compensation...

App. 3

Glossary... 235 App. 3.1 App. 3.2

App. 4

Navigation and editing symbols... Powering... Communication... Messages... Leakage...

Powering... Testing... Communication... Probe-fit related problems...

253 253 254 254

Technical Specifications - MADSEN OTOflex 100... 255 App. 6.1 OTOflex 100... App. 6.1.1 Compliance measuring system... App. 6.1.2 Acoustic Reflex... App. 6.1.3 Air pressure system...

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249 250 250 250 251

Troubleshooting... 253 App. 5.1 App. 5.2 App. 5.3 App. 5.4

App. 6

Terminology... 235 Abbreviations... 246

MADSEN OTOflex 100 Icons... 249 App. 4.1 App. 4.2 App. 4.3 App. 4.4 App. 4.5

App. 5

221 221 222 222 223 225 226 226 226 227 228 228 229 229 229 230 231 232 232

255 255 255 256

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Table of Contents MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

App. 6.1.4 Unit of admittance graph Y-axis... App. 6.1.5 Unit of graph X-axis... App. 6.1.6 Display... App. 6.1.7 Interface... App. 6.1.8 Type identification... App. 6.1.9 Power supply... App. 6.2 Charger unit... App. 6.3 Operating environment... App. 6.4 Storing and handling... App. 6.5 Dimensions... App. 6.6 Weight... App. 6.7 Miscellaneous... App. 6.8 Calibration... App. 6.9 Standards...

257 257 257 257 257 257 257 258 258 258 258 258 259 259

Index... 261

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1

Introduction

1.1

MADSEN OTOflex 100 Thank you for purchasing OTOflex 100. OTOflex 100 is a compact and portable wireless immittance test device, which offers a complete range of capabilities for middle ear diagnostics. OTOflex 100 can be operated anywhere as a stand-alone device or operated directly from OTOsuite. OTOflex 100 integrates closely with the OTOsuite Immittance Module, with full test control from both the device and OTOsuite. When used with OTOsuite, you gain additional features and diagnostic value offered by the comprehensive user interface and NOAH compatibility of OTOsuite. OTOflex 100 - OTOsuite interfacing

OTOflex 100 is designed to operate with the OTOsuite Immittance Module. Bluetooth

OTOflex 100 connects with OTOsuite via BluetoothTM, which provides wireless connection between OTOflex 100 and OTOsuite up to a range of approximately 10 metres (approx. 33 ft), and up to a range of 100 metres (approx. 330 ft) for other electronic devices. NOAH 3

The NOAH System is a HIMSA product for managing clients/patients, launching hearing test applications and fitting software, and storing audiological test results. OTOflex 100 test results can be stored in the NOAH 3 database via OTOsuite.

1.2

OTOsuite and the Immittance Module The OTOsuite Immittance Module offers real time presentation of test results and full test control of MADSEN OTOflex 100 directly from a PC. Test devices with integrated user interfaces can be operated independently of the Immittance Module, although additional features and diagnostic value is offered by the Immittance Module's comprehensive user interface and NOAH compatibility. The test functionalities of the OTOsuite Immittance Module depend on the connected device, as does the selection of test parameters, and remote control.

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Introduction Intended use

The OTOsuite Immittance Module lets you work with NOAH or save and view results via XML files. The OTOsuite Immittance Module supports • • • • •

screening and diagnostic tympanometry Reflex Threshold testing Reflex Decay testing ETF-P user-defined tests.

Immittance Module - OTOflex 100 interfacing

The Immittance Module is designed to operate with OTOflex 100 as the test device (produced by Otometrics). 1.2.1

The flexibility of the OTOsuite Immittance Module

When used for testing, the OTOsuite Immittance Module adapts to the connected test device. Consequently, the test functionalities of the OTOsuite Immittance Module depend on the connected device, as does the selection of test parameters, and remote control.

1.3

Intended use 1.3.1

MADSEN OTOflex 100

OTOflex 100 is an audiodiagnostic device intended for clinical, diagnostic and screening tympanometry and reflex measurements performed by audiologists, ENTs and other health care professionals. It is designed for use on infants, children and adults, and is lightweight, fast, reliable, and easy to use. OTOflex 100 uses technologies which are highly effective for clinical and screening purposes. Tympanometry and Acoustic Reflex measurements measure the mechanical response of the middle ear and form a basis for evaluating whether the related physiological structures are functioning correctly or not. The OTOflex 100 probe is extremely lightweight (only 4.5 grams), and comes with comfortable, easy to insert eartips. This makes it ideal for use with children and adults. OTOflex 100 can be configured for a wide variety of tests, and it can be operated entirely manually or programmed for the user’s own combination of manual and automatic operation. In user-programmable tests the user can select the default parameters of a particular test, and combine tests to form a sequence of preset tests.

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Introduction About this manual

1.3.2

The Immittance Module

The Immittance Module is intended for clinical, diagnostic and screening tympanometry and reflex measurements performed by audiologists, ENTs and other health care professionals.

1.4

About this manual This is your guide to using MADSEN OTOflex 100 and the OTOsuite Immittance Module. It also introduces you to the key features of the program by providing you with working scenarios for performing tests and viewing and printing test results. We recommend that you read this manual and make yourself familiar with the OTOflex 100 and how it operates with the OTOsuite Immittance Module so that you become familiar with the device before testing on a client. Note · If you are using the OTOsuite Immittance Module with NOAH 3, we recommend that you are familiar with the screens and functions provided in NOAH 3. We recommend that you make yourself familiar with the issues listed below: 1.4.1

Safety

This manual contains information and warnings which must be followed to ensure the safe performance of OTOflex 100. Warning · Local government rules and regulations, if applicable, should also be followed at all times. Safety information is stated where it is relevant, and general safety aspects are described in App. 1 Standards and safety - OTOflex 100 and the Immittance Module  215. 1.4.2

Installation

• To install the new system, see 15 Installing MADSEN OTOflex 100  199. Installation of OTOsuite is described in detail in the OTOsuite User Manual. Connecting to OTOflex 100

• See the OTOsuite User Manual. Configuring the OTOsuite Immittance Module

• See 16 Configuring OTOsuite  213. Basic OTOsuite functions

The basic OTOsuite functions are described in the OTOsuite User Manual.

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Introduction Typographical conventions

1.4.3

Descriptions and testing

If your new system is already installed, see • 2 Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module  17 • 4 Navigating in the OTOsuite Immittance Module  33 • 7 Testing with MADSEN OTOflex 100  67 1.4.4

Preparing for testing

Before you receive the client and start the session of testing and explaining test results, your time is well spent preparing for the session. See 6 Preparing OTOflex 100 and the Immittance Module for testing  49. 1.4.5

Printing

• For instructions on how to print OTOflex 100 results, see 9 Printing  105. • For instructions on how to print from the PC, see 14 OTOflex 100 Service and Maintenance  191. 1.4.6

Maintenance and cleaning

For instructions on how and when to clean OTOflex 100, please see the OTOflex 100 Guide. We recommend that you take particular note of the cleaning and maintenance instructions. Failure to use and maintain the OTOflex 100 correctly may void your warranty.

1.5

Typographical conventions The use of WARNING, CAUTION and NOTE

For safety reasons and appropriate use of OTOflex 100, the Guide contains WARNINGS, CAUTIONS and NOTES, which you should read carefully. Warning · indicates that there is risk of danger to persons and/or device. Caution · indicates that there is risk of damage to the device. Note · indicates that you should take special notice. 1.5.1

Navigation

Menus, icons and functions to select are shown in bold type, as for instance in:

14

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Introduction Typographical conventions

• Click the Set options icon on the toolbar or select Tools > Options..

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15

Introduction Typographical conventions

16

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2

Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module

2.1

Unpacking 1. Inspect the package and its contents for possible visual damage. 2. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is incomplete, contact your supplier.

2.2

Installation 1. Install OTOsuite from the OTOsuite Installation CD. See the OTOsuite User Manual. 2. Install OTOflex 100 as described in 15 Installing MADSEN OTOflex 100  199.

2.3

Starting up OTOflex 100 1. Starting up OTOsuite is described in the OTOsuite User Manual. 2. To switch on OTOflex 100 press the On/Off key.

On/Off Press & hold to switch on/off.

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Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module Starting up OTOflex 100

Handling Probe

To operate OTOflex 100, hold it with one hand (left or right). Use your thumb to press the keys on the keypad and turn the scroll wheel. Switching on

Probe plug

Screen

Keypad

Device colour code

To switch on OTOflex 100, press and hold the On/Off key on the keypad until the start-up screen appears. Switching off

To switch off OTOflex 100, press and hold the On/Off key on the keypad until the message “Power Off ” appears.

When you have installed OTOflex 100, there are a number of settings you can customise for your use. See 12.2.4 Device settings  145. • • • •

Check the specific device settings. If required, adjust the altitude setting. Set up the user(s) who will be using OTOflex 100. See 6.3.6 Users  60 Check the default test settings to acquaint yourself with the various settings. See 12.1 Test settings  135. • If required, create new test settings to suit your methods of testing.

2.3.1

Language setting

If the language setting in your OTOflex 100 has not been set to your local language from the factory, select the appropriate language: 1. Switch on your OTOflex 100. – If the “Patient & User” screen appears, press the softkey Return to previous to go to the Tympanometry test screen. menu – If the “Load Settings” screen appears (depending on setting in Menu > Procedure Options > ‘Settings’ prompt), press the left softkey Cancel to go to the Tympanometry test screen.

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Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module Starting up the Immittance Module

2. With the cursor highlighting the Menu icon to activate the Menu.

, press Select

3. Use the Scroll Wheel to scroll to Advanced.. and press Select 4. Scroll to Device Settings.. and press Select 5. Scroll to Localization.. and press Select 6. With Language highlighted, press Select

on the keypad .

.

. to access the language options.

7. Scroll to the language of your choice and press Select . to go to the Tympanometry test 8. Press the softkey Return to test screen screen.

2.4

Starting up the Immittance Module Starting the Immittance Module depends on the setup of the program. 1. Switch on OTOflex 100, if you wish to test patients or transfer test results. 2. Follow the instructions in the OTOsuite User Manual. – Select or create a client in OTOsuite. – Select the test type. – Activate the Control Panel. – Select test ear.

2.5

Immittance Module features General features

Depending on the configuration of OTOflex 100 and the Immittance Module, you can • handle patient lists, • view and print test results, • view the progression of a range of tests online, • view historic tympanometry results from NOAH or XML, • view online tympanometry results during testing, • perform “over the rim” testing, using the audiometer as a handy control panel while you follow stimulus settings and test progress on your PC display, • plan patients for offline testing, • upload test results from offline tests. The basic Immittance Module functions are described in 4 Navigating in the OTOsuite Immittance Module  33.

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Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module Immittance Module features

Preparing for testing

Before you receive the client and start the session of testing and explaining test results, your time is well spent preparing for the session. • Test preparations are described in 6 Preparing OTOflex 100 and the Immittance Module for testing  49.

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3

OTOflex 100 views and main description

3.1

Handling and switching on OTOflex 100 Handling Probe

To operate OTOflex 100, hold it with one hand (left or right). Use your thumb to press the keys on the keypad and turn the scroll wheel. Switching on

Probe plug

Screen

Keypad

Device colour code

3.1.1

To switch on OTOflex 100, press and hold the On/Off key on the keypad until the start-up screen appears. Switching off

To switch off OTOflex 100, press and hold the On/Off key on the keypad until the message “Power Off ” appears.

Keypad main functions

To operate OTOflex 100 hand-held, hold it with one hand (left or right). Use your thumb to press the keys on the keypad and turn the scroll wheel. You can access most of the functions available in OTOflex 100 via the Menu, or by pressing one or more keys and softkeys.

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21