MADSEN OTOflex 100 immittance test device, OTOsuite immittance module User Manual

MADSEN OTOflex 100 immittance test device, OTOsuite immittance module User Manual

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MADSEN OTOflex 100 & OTOsuite Immittance Module are 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.

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MADSEN OTOflex 100 & OTOsuite Immittance Module User Manual | Manualzz

0 4 5 9

Doc no. 7-50-0880-EN/12

MADSEN OTOflex 100 &

OTOsuite Immittance Module

User Manual

Copyright notice

No part of this Manual or program may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written consent of GN Otometrics A/S.

Copyright

©

2010, GN Otometrics A/S

Printed in Denmark by GN Otometrics A/S, Denmark

All information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time without notice.

Version release date

7. June 2010

Technical support

Please contact your supplier.

FM template version: 01-02-2010

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

3

Otometrics

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 . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.1.1

Edit menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.1.2

Measurement menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.1.3

Tools menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.1.4

Additional icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4.2 The Immittance Module Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4.2.1

Sequence selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.2

Test control buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.3

Changing Control Panel settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.3 The Tympanometry screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.4 The Acoustic Reflex screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4.4.1

The Reflex Screening screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.4.2

The Reflex Threshold screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.4.3

The Reflex Decay screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

4.5 The ETF-P screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

4.5.1

The post-analysis tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5 Test Device Management in OTOsuite

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.1 Setting up communication with the test device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.1.1

Selecting test devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.1.2

Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.1.3

Connecting to a test device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.1.4

Reconnecting to a test device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.1.5

Test device information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.1.6

Firmware upgrade - test devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

6 Preparing OTOflex 100 and the Immittance Module for testing

. . . . 49

6.1 Preparing the test environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

6.1.1

The test environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

6.2 Hygienic precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

6.3 Preparing OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

6.3.1

Preparing the probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

6.3.2

Using cap and/or handgrip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

6.3.3

Probe check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

6.3.4

Selecting patient folder and test type in OTOflex 100 . . . . . . . . . . . . . . . . . 58

6.3.5

Test flow setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6.3.6

Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

6.4 Preparing the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

6.4.1

Fitting the eartip on the probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

6.4.2

Fitting the probe in the patient’s ear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

6.4.3

Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

6.5 Preparing for the next patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

4

Otometrics

Otometrics

Table of Contents

MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

7 Testing with MADSEN OTOflex 100

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

7.1 Fast diagnostics - the quick approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

7.2 General test softkeys and shortcuts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

7.3 Start testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

7.4 Sequence testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

7.4.1

Selecting a test sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

7.4.2

Running a test sequence from OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . 70

7.5 Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

7.5.1

Screening tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

7.5.2

Reflex screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

7.5.3

Settings - Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

7.6 Tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

7.6.1

Tympanometry softkeys and shortcuts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

7.6.2

Diagnostic tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

7.6.3

The diagnostic tympanometry result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7.6.4

Settings - Diagnostic tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

7.7 ETF-I (Eustachian Tube Function - Intact) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

7.7.1

Settings - ETF-I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

7.8 Acoustic reflex testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

7.9 Reflex Threshold testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

7.9.1

Keys and functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

7.9.2

Automatic and semi-automatic Reflex Threshold testing . . . . . . . . . . . . . . . . 84

7.9.3

Viewing Reflex threshold results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

7.9.4

Settings - Automatic and semi-automatic Reflex Threshold . . . . . . . . . . . . . 87

7.9.5

Manual Reflex Threshold testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

7.9.6

The Reflex Threshold results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

7.9.7

Manually selecting/deselecting Reflex Threshold values . . . . . . . . . . . . . . . . 89

7.10 Reflex Decay testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

7.10.1 Keys and functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

7.10.2 Automatic Reflex Decay testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.10.3 Settings - Automatic Reflex Decay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

7.10.4 The Reflex Decay results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

7.10.5 Manual Reflex Decay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

7.11 ETF-P testing (Eustachian Tube Function - Perforated) . . . . . . . . . . . . . . . . . . . . . . . 97

7.11.1 Idle mode functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

7.11.2 Pressure build functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

7.11.3 The test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

7.11.4 The ETF-P result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

7.11.5 The Immittance Module post-analysis tool - ETF-P . . . . . . . . . . . . . . . . . . . 99

8 Managing Test Results in OTOflex 100

. . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8.1 When testing is done . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8.2 Swap ear results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8.3 Delete measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8.3.1

Tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

5

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MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

8.3.2

Reflex Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8.4 Deleting Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

8.5 Communicating and synchronizing with OTOsuite . . . . . . . . . . . . . . . . . . . . . . . . . 102

8.5.1

Synchronizing data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

8.5.2

Synchronization of corrections made to Patient Folders . . . . . . . . . . . . . . . 103

9 Printing

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

10 Testing with the OTOsuite Immittance Module

. . . . . . . . . . . . . . . . . . . 107

10.1 Sequence testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

10.1.1 Selecting a test sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

10.1.2 T + RS (Tympanometry + Reflex Screening) . . . . . . . . . . . . . . . . . . . . . . . . 107

10.1.3 T + RT (Tympanometry + Reflex Thresholds) . . . . . . . . . . . . . . . . . . . . . . 108

10.1.4 T + RT + RD (Tympanometry + Reflex Threshold + Reflex Decay) . . . . . . 108

10.1.5 Running a test sequence from the Immittance Module . . . . . . . . . . . . . . . . 108

10.2 Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

10.2.1 Screening tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

10.2.2 Acoustic Reflex Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

10.3 Tympanometric testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

10.3.1 Diagnostic tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

10.3.2 ETF-I, Eustachian Tube Function - Intact . . . . . . . . . . . . . . . . . . . . . . . . . 114

10.4 Acoustic Reflex Threshold testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

10.4.1 Automatic and semiautomatic threshold testing . . . . . . . . . . . . . . . . . . . . . 115

10.4.2 Manual threshold testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

10.5 Acoustic Reflex Decay testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

10.5.1 Automatic Acoustic Reflex Decay testing . . . . . . . . . . . . . . . . . . . . . . . . . . 122

10.5.2 Manual Acoustic Reflex Decay testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

10.6 ETF-P (Eustachian Tube Function - Perforated) . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

10.7 Managing test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

10.7.1 Tests and subtests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

10.7.2 Swapping ear data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

10.7.3 Deleting data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

10.8 Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

10.9 Testing the other ear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

10.10Saving measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

10.10.1 Standards used in NOAH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

10.11Preparing for the next patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

11 Data management in MADSEN OTOflex 100

. . . . . . . . . . . . . . . . . . . . . . 131

11.1 Data handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

11.1.1 Interruption of communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

11.1.2 Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

11.2 Uploading test results to OTOsuite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

11.3 Data clean-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6

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Otometrics

Table of Contents

MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

12 Immittance test setup in MADSEN OTOflex 100

. . . . . . . . . . . . . . . . . . 135

12.1 Test settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

12.1.1 Changing individual settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

12.1.2 Uploading test settings to the Immittance Module . . . . . . . . . . . . . . . . . . . 137

12.1.3 Creating a setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

12.1.4 Editing a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

12.1.5 Using a test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

12.2 General actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

12.2.1 Manage test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

12.2.2 Procedure options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

12.2.3 Advanced.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

12.2.4 Device settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

12.3 Tympanometry setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

12.3.1 Screening tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

12.3.2 ETF-I setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

12.4 Acoustic Reflex Screening setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

12.5 Acoustic Reflex Threshold setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

12.6 Acoustic Reflex Decay setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

12.7 ETF-P setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

12.8 Test sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

12.8.1 Selecting a sequence setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

13 Immittance Module Tools Options

(view and measurement options)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

13.1 General settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

13.1.1 Available settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

13.2 View settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

13.2.1 Tymp. and Reflex Scr. view settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

13.2.2 Reflex Threshold view settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

13.2.3 Reflex Decay view settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

13.2.4 ETF-P view settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

13.3 Measurement settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

13.3.1 Tympanometry setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

13.3.2 ETF-I Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

13.3.3 Acoustic Reflex Screening setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

13.3.4 Acoustic Reflex Threshold setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

13.3.5 Reflex Decay setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

13.3.6 ETF-P setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

14 OTOflex 100 Service and Maintenance

. . . . . . . . . . . . . . . . . . . . . . . . . . . 191

14.1 Equipment failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

14.2 Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

14.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

14.3.1 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

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MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

14.3.2 Probe cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

14.4 Cleaning and disinfecting the probe tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

14.4.1 Changing the wax filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

14.5 Cleaning OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

14.5.1 Eartips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

14.5.2 Disposal of disposable articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

14.5.3 Batteries and charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

14.5.4 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

14.5.5 Environmental protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

15 Installing MADSEN OTOflex 100

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

15.1 Unpacking OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

15.2 Storing OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

15.3 Views of OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

15.3.1 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

15.3.2 Top view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

15.3.3 Bottom view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

15.3.4 Reverse side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

15.3.5 The charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

15.4 The probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

15.5 Assembly and installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

15.5.1 Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

15.5.2 Desktop installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

15.5.3 Wall mount installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

15.6 Powering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

15.6.1 Powering OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

15.6.2 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

15.6.3 The charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

15.6.4 Switching on OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

15.6.5 Bluetooth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

16 Configuring OTOsuite

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

App. 1 Standards and safety - OTOflex 100 and

the Immittance Module

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

App. 1.1

Symbols used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

App. 1.1.1

OTOflex 100 symbols . . . . . . . . . . . . . . . . . . . . . . . . 215

App. 1.1.2

App. 1.1.3

Charger unit symbols . . . . . . . . . . . . . . . . . . . . . . . . . 216

The OTOsuite Audiometry Module . . . . . . . . . . . . . 217

App. 1.2

Warning notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

App. 1.2.1

OTOflex 100 warning notes . . . . . . . . . . . . . . . . . . . 217

App. 1.2.2

App. 1.3

Charger unit warning notes . . . . . . . . . . . . . . . . . . . . 219

Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

App. 1.3.1

Responsibility of the manufacturer . . . . . . . . . . . . . . . 219

8

Otometrics

Otometrics

App. 2

App. 3

App. 4

App. 5

App. 6

Table of Contents

MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

MADSEN OTOflex 100 Immittance

Methodology and Features

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

App. 2.1

An introduction to immittance . . . . . . . . . . . . . . . . . . . . . . . . 221

App. 2.1.1

App. 2.2

Immittance testing . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Tympanometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

App. 2.2.1

App. 2.2.2

App. 2.2.3

App. 2.2.4

Tympanometry testing on infants . . . . . . . . . . . . . . . 222

Tympanometric features . . . . . . . . . . . . . . . . . . . . . . 223

ETF-I (Eustachian Tube Function - Intact) . . . . . . . . 225

Valsalva’s Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . 226

App. 2.2.5

App. 2.3

Toynbee’s Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . 226

Acoustic Reflex testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

App. 2.3.1

App. 2.3.2

Acoustic Reflex Screening . . . . . . . . . . . . . . . . . . . . . 227

Acoustic Reflex Threshold . . . . . . . . . . . . . . . . . . . . . 228

App. 2.4

App. 2.5

App. 2.3.3

App. 2.3.4

Acoustic reflex decay . . . . . . . . . . . . . . . . . . . . . . . . . 228

Admittance monitoring . . . . . . . . . . . . . . . . . . . . . . . 229

ETF-P (Eustachian Tube Function - Perforated) . . . . . . . . . . . 229

Susceptance and Conductance, B/G . . . . . . . . . . . . . . . . . . . . 229

App. 2.5.1

App. 2.5.2

App. 2.5.3

App. 2.5.4

Susceptance, B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Conductance, G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

B/G viewing of tympanograms . . . . . . . . . . . . . . . . . . 232

Component compensation . . . . . . . . . . . . . . . . . . . . . 232

Glossary

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

App. 3.1

App. 3.2

Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

MADSEN OTOflex 100 Icons

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

App. 4.1

App. 4.2

App. 4.3

App. 4.4

App. 4.5

Navigation and editing symbols . . . . . . . . . . . . . . . . . . . . . . . . 249

Powering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

Troubleshooting

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

App. 5.1

App. 5.2

App. 5.3

App. 5.4

Powering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

Probe-fit related problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

Technical Specifications - MADSEN OTOflex 100

. . . . . . . . . 255

App. 6.1

OTOflex 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255

App. 6.1.1

App. 6.1.2

App. 6.1.3

Compliance measuring system . . . . . . . . . . . . . . . . . . 255

Acoustic Reflex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255

Air pressure system . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

9

Table of Contents

MADSEN OTOflex 100 & OTOsuite Immittance Module • User Manual

App. 6.1.4

App. 6.1.5

App. 6.1.6

App. 6.1.7

Unit of admittance graph Y-axis . . . . . . . . . . . . . . . . . 257

Unit of graph X-axis . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

App. 6.2

App. 6.3

App. 6.1.8

App. 6.1.9

Type identification . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Charger unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Operating environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

App. 6.4

App. 6.5

App. 6.6

App. 6.7

App. 6.8

App. 6.9

Storing and handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259

Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259

Index

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

10

Otometrics

1

1.1

1.2

Otometrics

Introduction

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 Bluetooth

TM

, 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.

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.

11

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.

12

Otometrics

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.

Otometrics

13

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

WARN-

INGS

,

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

Otometrics

Introduction

Typographical conventions

• Click the

Set options

icon on the toolbar or select

Tools > Options..

Otometrics

15

Introduction

Typographical conventions

16

Otometrics

2

2.1

2.2

2.3

Getting started with MADSEN OTOflex 100 and

the OTOsuite Immittance Module

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.

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 .

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.

Otometrics

17

Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module

Starting up OTOflex 100

Probe

Probe plug

Screen

Keypad

Device colour code

Handling

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

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 menu

to go to the Tympanometry test screen.

– 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.

18

Otometrics

2.4

2.5

Getting started with MADSEN OTOflex 100 and the OTOsuite Immittance Module

Starting up the Immittance Module

2. With the cursor highlighting the

Menu

icon , press

Select

on the keypad to activate the

Menu

.

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

to access the language options.

7. Scroll to the language of your choice and press

Select

.

8. Press the softkey

Return to test screen

to go to the Tympanometry test screen.

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.

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

.

Otometrics

19

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

.

20

Otometrics

3

3.1

OTOflex 100 views and main description

Handling and switching on OTOflex 100

Probe

Probe plug

Screen

Keypad

Device colour code

Handling

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

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.

3.1.1

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.

Otometrics

21

OTOflex 100 views and main description

Handling and switching on OTOflex 100

Left softkey

On/Off

Press & hold

Press & hold to switch on/off.

Press to toggle between test modes

Select key

Select highlighted item.

Toggle value settings

Press & hold to activate:

–Test editor

– Character Select in text

 mode

Right softkey

Ear Selector

Pressure release

Scroll wheel

Scroll to highlight item

Change intensity level

Scroll to value setting

Scroll between test types

Scroll wheel

Turn the scroll wheel to shift the focus on the screen or change values:

Scroll up

Turn counter-clockwise to scroll up.

Moves the focus up or to the left, or decreases a selected value

Scroll down

Turn clockwise to scroll down

Moves the focus down or to the right, or increases a selected value

Select

Press and hold to activate the Test Selector (see 3.2.2 Test

Selector mode  27

)

Menu

Press to access the Menu

Activate item

Press to activate the selected item

Additional scroll sheel modes

Test Selector mode

Scroll between test types (

3.2.2 Test Selector mode  27 )

Text Editor mode

Scroll to select characters (

3.2.3 The Text Editor  29

)

22

Otometrics

Otometrics

OTOflex 100 views and main description

Handling and switching on OTOflex 100

Softkeys

The current functions of the two softkeys are shown at the bottom of the screen, just above each softkey.

During testing

Pressure release

Press for immediate release of air pressure and stop/pause of measurement.

Between measurements

Ear selection

Press to toggle the ear selection associated with the current measurement

On/Off

Press and hold 3-5 seconds to turn the device on or off

Toggle test type

Press to toggle between test types

Left softkey

1 2 3

Tymp curve selector

Stop reflex measurement

Right softkey

Start tymp measurement

Start automatic measurement

Start automatic reflex measurement.

Pause measurement

Flashing: resume measurement

Start semi-automatic measurement.

Start reflex search for selected stimulus.

Mark threshold

Unmark threshold

Return to previous menu

Menu

Press & hold for patient info

Start single stimulus

Stop tymp measurement

Automatically pump to positive pressure in ETF-P

Automatically pump to negative pressure in ETF-P

Return to test screen

Press & hold to start test sequence

23

OTOflex 100 views and main description

Handling and switching on OTOflex 100

Left softkey

3.1.2

The display - test mode

The test screens display a number of icons:

Selected test setting

Ear selection

L = Left

R = Right

Right softkey

Print ( 9 Printing  105

)

Connection indicator

Power indicator

24

Patient

Menu and settings

Selected test sequence

Selected test

Start measurement/test sequence

Tympanometric curve selector

Icons

R L

1 2 3

Ear selection: the ear selection icon shows the ear selected for testing.

Connection indicator: Bluetooth communication disabled in menu.

Connection indicator: Bluetooth communication is established.

Connection indicator: Bluetooth communication is interrupted.

Power indicator. OTOflex 100 receives power from the charger.

Power indicator. OTOflex 100 is powered by batteries.

Menu and settings icon. Press

Select

to access when highlighted.

Curve selector. See the specific test procedures.

Otometrics

OTOflex 100 views and main description

Controls and menu selections

3.2

Controls and menu selections

You can access most of the functions available in OTOflex 100 via the

Menu

, or by pressing one or more keys and softkeys.

There are a number of shortcuts and softkeys available for quick and easy navigation of OTOflex 100.

See

7 Testing with MADSEN OTOflex 100  67 .

Test specific shortcuts and softkeys are listed in the specific test sections.

3.2.1

The Menu

Scroll to the

Menu

icon and press

Select

to access the

Menu

. From the

Menu

you can access most functions available in OTOflex 100.

When you navigate the menu, the following symbols are used as softkey functions:

Scroll bar

Use scroll mwheel to navigate

Otometrics

Return to previous menu

Return to test screen/Test

Selector

Softkeys

Left

Right

• Press to return to previous screen

• Press to return to test screen/Test Selector

Menu >

From the

Menu

you can access general functions, test specific functions, and functions related to device settings. See the list below.

• Start sequence ( 7.4.2 Running a test sequence from OTOflex 100  70 )

• Test selector ( 3.2.2 Test Selector mode  27

)

25

OTOflex 100 views and main description

Controls and menu selections

• Printers (

9 Printing  105 )

• Patient & User.. ( 6.3.4 Selecting patient folder and test type in

OTOflex 100  58 )

incl. Select User

• My settings.. ( 12.1 Test settings  135

)

> Load settings.. 

> Save settings 

> Save settings as..

> Delete settings..

> Load factory settings..

• Done! (

6.3.5 Test flow setup  59 )

• Probe check (

6.3.3 Probe check  57 )

• Most frequently used test specific settings are listed directly in the

Menu

. See the specific test settings in

12 Immittance test setup in MADSEN

OTOflex 100  135 .

• More settings..

Sub-menu containing less frequently used test specific settings. See the specific test settings in

12 Immittance test setup in MADSEN OTOflex 100  135

.

• Manage test results:

> Load patient..

> Swap ear results

> Del(ete) sub-test..

> Del(ete) current test

> Del(ete) patient

> Del(ete) all printed patients

> Del(ete) all patients

• Procedure Options..

> Sequence 

> Auto start on seal

> Auto resume on seal

> Auto free memory

> First ear to test

> 226 Hz tymp unit

> 226 Hz deflection unit

> Intensity safety

> ‘Done?’ prompt

> Print when done

> ‘Patient’ prompt

> ‘Settings’ prompt

• Advanced

> Dissociate from PC

> Users.. > Create user, Delete user

> Device settings.. > Device info, Brightness, Bluetooth, Battery type, Altitude ab(ove) sea (level), Bat(tery) power save, Bat(tery) power off, Charger powersave,

26

Otometrics

OTOflex 100 views and main description

Controls and menu selections

Charger poweroff, No power off before, Localization.. (> Language, Date format, Decimal separator, Probe standard), Set time..Calib. old warning, Load factory settings..

> Service.. (password protected)

3.2.2

Test Selector mode

Note ·

The easiest way to change from one test to another is to briefly press the

On/Off

button.

In

Test Selector

mode, you can scroll through each of the displays for the individual tests types. For tympanometry this includes a Tymp Data screen with additional results.

In

Test Selector

mode, no items in the test screens will have focus, i.e. no screen items can be selected and no deflection curves are displayed.

1. Press and hold the

Select

key to see the double arrows at the bottom of the screen.

The

double arrows

indicate that you can use the scroll wheel to scroll in either direction to view the specific test types.

Test selector mode

Menu and settings

Current sequence

Current test

Print

2. Scroll to the required test type and press

Select

.

You can now carry out testing, view data, etc.

Note ·

To return to the test that was selected when you activated the

Test Selector

mode without selecting the displayed test: Press and hold the

Select

key.

Otometrics

27

OTOflex 100 views and main description

Controls and menu selections

Keypad

Select

• Press and hold to activate the

Test Selector

(see

3.2.2 Test

Selector mode  27 ).

• Press to activate the selected test.

• Press and hold in

Test Selector

mode to return to the test that was selected when you activated the

Test Selector

.

Softkeys

Left

Right

• Press to carry out the function according to the icon shown, Tymp curve select, or Enter menu

• Press and hold to display patient and user info

• Press to carry out the function according to the icon shown (typically starts, stops, pauses, or continues a test).

Print is always available in this mode

• Press and hold to start the currently selected test sequence indicated at the top of the screen

Icons

Menu and settings icon. Press

Select

to access when highlighted.

Test selector or Text editor

Use scroll wheel to change test in test select mode or to move to another character in character position mode during text editing.

Print

Print test results ( 9 Printing  105 )

28

Otometrics

OTOflex 100 views and main description

Controls and menu selections

3.2.3

The Text Editor

Entering data

Otometrics

Cancel

(do not use the edited text)

C

ANCEL ok

OK

(to accept the edited text)

Scroll wheel

Scroll to highlight field

Scroll to select character

Select

Press to access field

Press to enter character

Press and hold to enter

Character Select mode

In some screens you can enter text and numeric values.

1. Scroll to the field.

2. Press

Select

. The field now contains a small highlighted square.

3. Turn the

Scroll Wheel

until the required digit or letter is displayed and press

Select

.

4. Continue in this manner until you have entered the text or value required.

5. Press

OK

to confirm.

6. Turn the

Scroll Wheel

to go to the next field, and press

Select

to access the field.

7. If you need to move the cursor, and insert or delete letters/digits in the data field, see below for editing entered data.

Editing data

Character select indicator

Delete

Press to delete character

Select

Press to return to character entry mode

DEL INS

Insert

Press to insert space for a character

Scroll wheel

Scroll to highlight character

Scroll to select character

29

OTOflex 100 views and main description

Controls and menu selections

To edit data in the

Patient & User

screen:

1. Scroll to the field you wish to edit and press

Select

to access the field.

2. Press and hold

Select

to access

Character select

mode. The bottom of the screen shows

double arrows

to indicate that you can scroll to the required position in the field.

Editing characters

1. Scroll to the required position.

2. Press

Select

and scroll to change the character as required.

Deleting characters

• To delete a character, scroll to the character to be deleted and press the

DEL

softkey.

Editing settings

• Scroll to the setting you wish to change.

There are two main methods of editing data such as measurement settings:

Settings with two value options

Press

Select

to toggle the value in the settings field.

Settings with several value options

Press

Select

to access the settings field, and use the

Scroll Wheel

to scroll to the required setting.

3.2.4

The Tympanometric Curve Selector

With the

Curve Selector

1 2 3

, you can switch between the different tympanometric curve views. The data shown in the test screen or in the Tymp Data screen relates to the curve in focus.

Press the left softkey below the

Curve Selector

icon to toggle between the various curves (if available).

If

Menu > Layered curves

is On, all recorded tympanograms for the ear are shown overlayed with the selected curve highlighted.

3.2.5

The OTOflex 100 Menu

The

Menu

icon must be highlighted. If required, scroll to highlight.

Press

Select

to access the

Menu

. From the

Menu

you can access most functions available in OTOflex 100.

When you navigate the menu, the following functions are available:

30

Otometrics

Otometrics

OTOflex 100 views and main description

Controls and menu selections

Scroll bar

Use scroll wheel to navigate

Press to return to previous menu

Press to return to test screen/Test Selector

Menu >

From the

Menu

you can select menus and menu items for accessing general and Test management related actions, test specific and procedure related settings, as well as general procedure and device settings.

Actions

Start sequence

( 7.4 Sequence testing  69 )

Test selector

(

3.2.2 Test Selector mode  27

)

Printers..

( 9 Printing  105 )

Patient & User..

My settings..

> Load Settings.. 

> Save Settings 

> Save Settings As

> Delete Settings..

> Load Factory Settings..

Done!

(

6.3.5 Test flow setup  59

)

Probe Check

(

6.3.3 Probe check  57 )

- - - - - - - - - - - - - - - - - - - - - - - - - - -

Probe tone

..

..

More Settings

- - - - - - - - - - - - - - - - - - - - - - - - - - -

Manage Test Results..

> Swap Ear Results

> Del(ete) Sub-test..

> Del(ete) Current Test..

> Del(ete) Patient..

> Del(ete) All Printed Patients

> Del(ete) all Patients

Settings specific to the selected test type

General settings

31

OTOflex 100 views and main description

Controls and menu selections

Procedure Options..

> Sequence ( 7.4 Sequence testing  69 )

> Auto start on seal

> Auto resume on seal

> Auto free memory 

> First ear to test

> 226 Hz tymp unit

> 226 Hz deflection unit

> Reflex adjustment

> Intensity safety (see 12.2.2 Procedure options  141

)

> “Done!” prompt (page

49

)

> Print when done (page

49

)

> “Patient” prompt (page

49 )

> “Setting” prompt (page

49

)

Advanced..

> Dissociate from PC

> Users..

> Device settings.. 

> Service.. (password protected)

General settings

General settings

General actions

Advanced settings and actions

32

Otometrics

4

Menu bar

Navigating in the OTOsuite Immittance Module

The general functions for navigating in the OTOsuite main window are described in the OTOsuite manual.

Tympanometry elements

Tympanometry toolbar

Control panel

Result table

Work area

4.1

Screen descriptions

You will find descriptions of the actual screens and how to use and view them in:

4.3 The Tympanometry screen  37 

4.4 The Acoustic Reflex screens  38

4.5 The ETF-P screen  43

The Immittance Module menu system and toolbar

The

Menu bar

is located at the top of the window. Some of the menu items are also available as icons.

The icons available in the

Toolbar

depend on the test functions included in your

OTOsuite.

Otometrics

33

Navigating in the OTOsuite Immittance Module

The Immittance Module menu system and toolbar

Tympanometry icons

Some of the icons in the Immittance toolbar are toggle icons. Click to toggle to another selection.

4.1.1

Edit menu

Delete Selected Sub-test (Del)

See 10.7.3 Deleting data  127 .

Delete Selected Test

See 10.7.3 Deleting data  127 .

4.1.2

Measurement menu

Get Test Results from Device (Ctrl + G)

Get Test Results

Opens the dialog box for uploading patient folders

from the test device. See 11.2 Uploading test results to OTOsuite  132

.

4.1.3

Tools menu

Select and Manage Test Devices.. (F9)

See description in 11.2 Uploading test results to

OTOsuite  132

.

Options (Ctrl + M)

For setting up a range of settings relating to test han-

dling and viewing. See 13 Immittance Module Tools

Options (view and measurement options)  169

.

34

Otometrics

Navigating in the OTOsuite Immittance Module

The Immittance Module Control Panel

4.1.4

Additional icons

Toolbar

Select device

Opens the dialog box for selecting the device for testing. See

5.1.1 Selecting test devices  45 .

Toolbar

Show previous/next curves

Toggles between specific curves on the tympanogram.

See 4.3 The Tympanometry screen  37 .

Toolbar

Show previous/next reflex curve

Toggles between the visible reflex curves. See 4.4 The

Acoustic Reflex screens  38 .

Toolbar

Show B/G or Y (Show conductance and susceptance data/Show admittance data)

Toggle this icon to see the admittance components conductance and susceptance, or admittance data.

Toolbar

Auto scale (tympanogram)

Click on this icon to select/deselect autoscaling of a tympanogram. When you change the ear or the patient, the scale will revert to the default scale. When auto scale is active, this icon is displayed as being enabled (lighter background colour).

4.2

Otometrics

The Immittance Module Control Panel

The general function of the Control Panel is described in the OTOsuite User Manual.

The appearance of the control panels is specific to the OTOflex 100 connected to the

Immittance Module and to the selected test type. See 5.1 Setting up communication with the test device  45 .

35

Navigating in the OTOsuite Immittance Module

The Immittance Module Control Panel

If OTOsuite is connected to OTOflex 100, a Reflex Threshold control panel may appear as shown.

The control panel is divided into panes:

Test settings specific to the individual tests

• If you wish to change the default test settings, simply select from the drop-down menus, and click on the appropriate radio buttons or check-boxes. See also

13 Immittance Module Tools Options (view and measurement options)  169 .

4.2.1

Sequence selection

The drop-down list for selecting sequences is located in the

Sequence

field below the

Control Panel

.

36

• Test sequences are described in detail in

10.1 Sequence testing  107 .

4.2.2

Test control buttons

Test control buttons are used in the various panes in the Control Panel.

Start/pause

a sequence.

Start

a test.

Start

a fully automatic reflex test.

Start

a semi-automatic reflex test.

Start stimulus

to present a single stimulus intensity.

Stop

the test immediately.

Otometrics

Navigating in the OTOsuite Immittance Module

The Tympanometry screen

Pause

to manually pause the progress of a sequence. When

Pause

flashes, click again to resume testing.

Skip

the ongoing measurement and continue with the next.

Pressure control

in ETF-P.

4.3

4.2.3

Changing Control Panel settings

When you activate the test device, the settings used in the device are automatically shown in the Control Panel. See the OTOsuite User Manual.

The Tympanometry screen

Otometrics

The Tympanometry screen shows

• the tympanometric curves

• norm area, if selected

• Probe tone

• TPP (Tympanometric Peak Pressure)

• SA/SC (Static Admittance/Static Compliance)

• TW (Tympanometric Width)

• ECV (Ear Canal Volume)

• Type, if selected (if normal region and baseline are enabled).

37

Navigating in the OTOsuite Immittance Module

The Acoustic Reflex screens

Scaling the tympanogram

• Autoscale tympanogram

Enables automatic rescaling to an appropriate value in order to display the entire curve.

When no data is available, the scale selected will be used.

Note ·

Autoscaling adjusts viewing dynamically according to the highest of all currently displayed curves, so that you can visually compare ear results.

Viewing the tympanogram

The tympanogram can be viewed in four different ways

• traditional total admittance, Y

• traditional baseline compensated admittance, Y tm

• susceptance, B, and conductance, G; both total and compensated

• component compensated admittance, Y tm

Tympanometric curves

The Tympanometry graph shows a maximum of 3 curves per ear per patient.

• Click on one of the curves in this icon group to view a specific curve on the tympanogram.

4.4

The Acoustic Reflex screens

To perform acoustic reflex threshold testing, see

10.4 Acoustic Reflex Threshold testing  114

To perform acoustic reflex decay testing, see

10.5 Acoustic Reflex Decay testing  121

38

Otometrics

4.4.1

The Reflex Screening screen

Navigating in the OTOsuite Immittance Module

The Acoustic Reflex screens

Otometrics

Field results

Check marks or hyphens or indicate whether a reflex has been detected or not.

This applies when only one intensity is selected in the test setting

Tools > Options >

Tymp. and Reflex Scr. > Stimulus intensities > Number of Intensities

.

Numerical values or crossed out numerical values indicate whether a reflex has been detected or not. This applies when more than one intensity is selected in the test setting

Tools > Options > Tymp. and Reflex Scr. > Stimulus intensities - Number of

Intensities

.

Reflex Screening table - Tympanometry screen

The Reflex Screening section in the Tympanometry screen shows reflex screening values, if reflex screening measurements are available, or crossed out values, if they are not.

The Ipsi results appear in the top row. The stimulus ear referenced contra-lateral results appear in the bottom row.

If, subsequently, a Reflex Threshold test is made, using the same stimulus types as in Reflex Screening, the screening values will disappear from the Reflex

Screening results table in the Tympanometry screen. Any stimulus types that are not tested during a Reflex Thresholds test will remain in the Reflex Screening results table.

Note ·

If you try to do a Reflex Screening for fields where Threshold values are available, you will be prompted to decide whether to proceed.

39

Navigating in the OTOsuite Immittance Module

The Acoustic Reflex screens

When this happens, always check your Reflex Thresholds screen to check whether you want to overwrite the Threshold results in question.

4.4.2

The Reflex Threshold screen

• Click on one of the graphs in this icon group to scroll between the graphs in the reflex measurement.

40

Field results

Deflection curves

The graph representing the automatically determined threshold at the top of the screen is shown in a frame.

The numerical values listed above each graph (for instance 

0.05, 80 dB HL) indicate the max. deflection of the curve, and the stimulus intensity used.

Thresholds table

• The determined threshold is shown in the Thresholds table in the bottom part of the screen. If no threshold is detected, the field in the Thresholds table will show the text “None” to indicate the absent threshold.

The Ipsi results appear in the top row. The stimulus ear referenced contra-lateral results appear in the bottom row.

Otometrics

Otometrics

Navigating in the OTOsuite Immittance Module

The Acoustic Reflex screens

Thresholds table

The Thresholds table shows reflex screening results, if reflex screening measurements are available.

The title field in the Thresholds table includes an indication of the probe tone used and the air pressure applied (for instance 226 Hz, 50 daPa). The values refer to the field currently selected and therefore highlighted in the table. As you click the individual fields in the table, the values listed in the title field will be updated to reflect the field currently selected.

If, subsequently, a Reflex Threshold test is made, the table becomes a Reflex

Threshold results table, now titled

Thresholds, db HL (scr. hidden)

. The screening values will be removed from the Reflex Threshold table, and can only be found in the

Reflex Screening table - Tympanometry screen

.

Accordingly, screening results and threshold results are never mixed in a results table.

– If you want to manually change the threshold, click on the drop-down box of the specific field in the Thresholds table and select the stimulus intensity to be reported as the threshold value. The manually selected value will be marked by an asterisk, the appropriate graph at the top of the screen is framed accordingly, and the audiogram marker in the audiogram in the bottom right part of the screen is updated.

Tympanogram

In the top right corner of the screen, the most recent tympanogram, if available for the currently used probe tone, is displayed, and a marker on the pressure axis indicates the current ear canal pressure. The curve number is also indicated.

Audiogram

The audiogram marker in the audiogram in the bottom right part of the screen indicates the threshold level or the highest intensity where threshold was not found.

41

Navigating in the OTOsuite Immittance Module

The Acoustic Reflex screens

4.4.3

The Reflex Decay screen

42

Field results

Deflection

The deflection graph is limited by blue markers indicating stimulus on and off.

A third marker appears to indicate the half-life time where the curve decreases to

50% of its initial deflection.

Half-life time, seconds - Results table

• If the deflection decreases to 50% or more of the initial deflection during presentation of the stimulus, the point in time when this occurs is shown.

If no decay is registered, the field shows a dash.

The Ipsi results appear in the top row. The stimulus ear referenced contra-lateral results appear in the bottom row.

Tympanogram

In the top right corner of the screen, the most recent tympanogram, if available for the currently used probe tone, is displayed, and a marker on the pressure axis indicates the current ear canal pressure. The curve number is also indicated.

Otometrics

4.5

Navigating in the OTOsuite Immittance Module

The ETF-P screen

The ETF-P screen

To perform ETF-P testing, see 10.6 ETF-P (Eustachian Tube Function -

Perforated)  125 .

Field results

The time-pressure graph

As soon as the measurement is completed, the results are automatically determined and the pressure values are reported in the ETF-P result table.

Eustachian tube openings, daPa

The pressure values denoting the openings and closings of the Eustachian tube are determined from the plateaus of the curve.

4.5.1

The post-analysis tool

You can adjust the time-pressure graphs manually, if needed.

1. Click the line closest to the pressure value to be adjusted.

Otometrics

43

Navigating in the OTOsuite Immittance Module

The ETF-P screen

2. Click and hold the left mouse button on the line to move it to the desired position.

The corresponding values in the ETF-P table at the bottom of the screen change accordingly.

Note ·

You can only adjust the line within the range determined by the adjacent lines.

This is because the lines are linked to their individual result fields in the ETF-P table.

3. To delete a line, click on the line and press

Delete

on your keyboard.

4. To delete the entire measurement, click on the graph and press

Delete

on your keyboard.

44

Otometrics

5 Test Device Management in OTOsuite

5.1

Setting up communication with the test device

The first time you set up communication between your test device and OTOsuite, do as follows:

Communication with one test device

If you are setting up communication between OTOsuite and one test device, see

5.1.1 Selecting test devices  45 .

5.1.1

Selecting test devices

To set up communication between a test device and OTOsuite, do as follows:

1. The test device must be turned on and not connected to another pc.

2. Click the

Select Device

icon, or select

Tools > Select and Manage Test

Devices..

3. Currently known test devices are listed with name and serial number. Click the

Search

button, if the device you want to connect to is not listed. Searching for devices may take a couple of minutes. All test devices visible within the Bluetooth range will be added to the list.

4. Highlight the appropriate test device and click

Select

. OTOsuite will connect to the selected test device and close the dialog.

5. If needed, right-click the device name, and select

Rename

to change the name of the test device. You can change the name of a test device only when it is switched on, within range, and not connected to another pc.

Removing test devices

• Right-click the device name, and select

Delete

to remove the test device from the list. Removed devices can be added again using the

Search

button.

Restoring a faulty connection

• Click the

Repair

button to repair a faulty connection to the highlighted test device. Click

Search

if the repair function only made the test device disappear from the list.

Otometrics

45

Test Device Management in OTOsuite

Setting up communication with the test device

46

5.1.2

Connection

OTOsuite automatically connects to the test device when you activate the

Control

Panel

.

Make sure that the device is switched on.

5.1.3

Connecting to a test device

To connect to a test device, in OTOsuite click on

Control Panel

in the toolbar.

The

Control Panel

relating to the test device and the selected test type is shown in the left side of the screen.

License key

OTOsuite requires that you enter a connection license key for connecting to the test device. Contact your supplier if you do not have such a license key.

Firmware update

If a Firmware Update message appears, see 5.1.6 Firmware upgrade - test devices  46 .

5.1.4

Reconnecting to a test device

If the control panel for a test type is shown, and communication with the selected test device is interrupted, a message appears stating that there is no longer connection to the device.

• Click the

Connect

button on the

Control Panel

to reconnect to the selected test device.

5.1.5

Test device information

To see information relating to the test device, select

Help > About Device

.

5.1.6

Firmware upgrade - test devices

If your OTOsuite version contains a more recent firmware for your OTOflex 100, it is recommended that you update the firmware to make sure that OTOflex 100 and

OTOsuite perform correctly.

Upgrading of the firmware will leave your device settings unchanged.

The new firmware may take up slightly more OTOflex 100 memory than the previous version. If the memory is full of patient results, the upgrade process will automatically erase some of the oldest patient results from the OTOflex 100 memory if needed (results that have been saved or printed will be deleted first).

Otometrics

Otometrics

Test Device Management in OTOsuite

Setting up communication with the test device

It is recommended that you manually delete some or all patient results from

OTOflex 100 to create the necessary space for the upgrade.

Firmware upgrade procedure

1. Place OTOflex 100 in a powered charger near the PC and Bluetooth adapter.

2. Connect to the specific OTOflex 100 you want to upgrade from OTOsuite (as if you wanted to do testing).

3. Disconnect OTOflex 100.

4. In OTOsuite select

Tools > Configuration Wizard > Immittance Configure.. >

Next

to go to the

Firmware Update

screen.

5. Click the

Upgrade OTOflex firmware

button.

6. The Kernel Upgrade window appears.

Note ·

Your OTOflex 100 name and serial number will differ from that shown.

"New Kernel for

Upgrade" will display the newest firmware version available.

7. Click

Upgrade

to upgrade the

OTOflex 100 firmware.

47

Test Device Management in OTOsuite

Setting up communication with the test device

8. Wait.. 

Do not interrupt the upgrade in any way!

9. Turn OTOflex 100 off and back on.

10.When you have restarted OTOflex 100, click

OK

.

11.Check that there is

No newer kernel

for upgrade.

Click

OK

to finish the

OTOflex 100 firmware upgrade.

48

Otometrics

6 Preparing OTOflex 100 and the Immittance

Module for testing

Preparing for testing is an important part of testing. It is time-saving for both you and the client if the environment, the client and the test device setup and program are ready for the test.

To prepare for testing:

• Decide whether to use the cap and/or handgrip. See

6.3.2 Using cap and/or handgrip  51 .

• Connect the appropriate probe, and, if required, the insert phone. See

6.3.1 Preparing the probe  50

.

• Prepare OTOflex 100 and the Immittance Module: select the appropriate patient and test setup. See the OTOsuite User Manual.

• Prepare the patient. See

6.4 Preparing the patient  61

.

• Prepare probe and eartip. See 6.4.1 Fitting the eartip on the probe  61 and

6.4.2 Fitting the probe in the patient’s ear  62

.

• If this is the first test of the day, make a probe check. See 6.3.3 Probe check  57 .

6.1

Preparing the test environment

Before you start testing, make sure that the test environment is conducive to testing.

This includes factors such as selecting a test location where environmental influence on test results is minimal, and ensuring that hygienic precautions are taken to protect the patient from cross-infection, and setting up equipment such as speakers, test device and computers.

6.1.1

The test environment

The test environment should in some cases be adapted to suit the specific test types.

Immittance tests require no specific test environment with regard to noise. However, a quiet location is always more conducive to testing, both with regard to noise and to making sure that the patient is not influenced by factors other than the test itself and the person performing the test.

Otometrics

49

Preparing OTOflex 100 and the Immittance Module for testing

Hygienic precautions

6.2

Hygienic precautions

• Be sure to follow any established infection control procedures for the setting in which you are working.

• Always use clean eartips.

• Swab the probe tip with disinfectant between ears. If one ear is infected, test the healthy ear first and change eartips between ears.

• To prevent cross-infection, use a clean eartip when you test the next patient.

6.3

Preparing OTOflex 100

6.3.1

Preparing the probe

Select the appropriate probe for testing.

Using probe with short cable

To mount the cap, see 6.3.2.1 The cap  51 .

The short cable is best suited for use combined with the cap mounted on

OTOflex 100.

Using probe with long cable

If available, the probe with the long cable is best suited for diagnostic and clinical test purposes. It allows for placing OTOflex 100 near the patient, or for using it wallmounted in a fixed position.

See

6.3.2.2 Removing the cap  54 .

If the probe cap is mounted on OTOflex 100, remove it.

50

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

6.3.1.1

Connecting probe and insert phone

The following applies both to the OTOflex 100 probe and the E-A-RTONE® 3A insert phone.

OTOflex 100 comes with a probe for immittance testing. The probe is fitted with either a long or a short cable, depending on how you wish to use the device. Suggestions for use are described in

6.3.1 Preparing the probe  50 .

The OTOflex 100 probe

Plug the OTOflex 100 probe into the probe socket. Make sure that you insert the pin for the pneumatic pump into the pneumatic connection.

The E-A-R TONE 3A insert phone

If available, plug the E-A-R TONE 3A insert phone into the contralateral socket.

Probe

Pneumatic connection

Contralateral socket

Probe socket

Caution ·

Both the probe plug and the contralateral plug are equipped with a locking mechanism. Therefore, when you disconnect the probe, do not pull the plug by the cable.

Grip the probe by the sleeve of the plug and free it by gently pulling it away from the device.

The probe will not be released if you pull anywhere else than by the sleeve of the plug.

To fit the cap, see 6.3.2.1 The cap  51 .

Note ·

The probe forks on the charger base plate or on the wall mounting provide a practical place to keep the probe whenever you are not using the device (for instance when the batteries are charging).

6.3.2

Using cap and/or handgrip

When you have selected the probe for testing, you must decide how you wish to perform the test.

The setups described below are intended as suggestions for use, or you can use a setup of your own choice.

6.3.2.1

The cap

You can fit the probe directly on the cap of OTOflex 100. If you are using the probe with the short cable, you can place the cable in the cable track at the back of

OTOflex 100.

Otometrics

51

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

1. Fit the probe, and if required, insert phone on the OTOflex 100.

2. Mount the cap on OTOflex 100. To do so, place the two small projections

(located on the rear side of the cap) in the groove on the top front edge of

OTOflex 100.

Cap

Projections

Wings

Groove

3. Snap the wings into place by pressing them downwards into the two recesses in the top rear edge.

52

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

Recesses

Otometrics

4. Place the neck of the probe in the probe holder in the cap. Make sure that the probe cable fits in the small indent.

Probe holder Probe neck

Indent for probe cable

53

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

Probe cable track

54

6.3.2.2

5. If you are using the probe with the short cable, you can place the cable in the cable track on the back of OTOflex 100 to avoid cables getting tangled.

Removing the cap

1. Remove the probe from the cap.

2. Remove the cap from OTOflex 100. To do so, press the wings of the cap gently towards each other and ease the cap out of its groove.

Cap

Otometrics

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

6.3.2.3

The handgrip

You can use the probe with the handgrip fitted on OTOflex 100.

The handgrip provides enhanced maneuverability when you are testing with a screening eartip.

If you are testing with a short probe cable and with the handgrip attached to

OTOflex 100, the whole unit becomes a practical immittance screening device.

Screening, where the handgrip can be used in combination with a long probe cable, is easily done with OTOflex 100 in its charger or placed on a surface nearby.

1. Mount the cap on OTOflex 100. See above.

2. Mount the handgrip as shown below. Make sure that the handgrip is oriented correctly in relation to the cap. Make sure that the snap locks click into place in the catches in the cap to secure the handgrip firmly on the cap and

OTOflex 100.

55

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

6.3.2.4

Removing the handgrip

1. To dismount the handgrip, squeeze the sides of the handgrip firmly together at the points shown by the arrows. Wriggle the snap locks out of the catches in the cap to free the handgrip from the cap.

56

6.3.2.5

Using handgrip and cap

For purposes such as screening you can use the handgrip with the cap.

1. Mount the handgrip on the cap.

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

2. Use the probe with the long cable for testing.

6.3.3

Probe check

It is recommended that you perform a probe check at the start of each day, or when there has been a change in barometric pressure, to make sure that the probe is functioning correctly.

1. Make sure that the probe tip has been cleaned and disinfected before you place it

in the test cavity. See 14.4 Cleaning and disinfecting the probe tip  193 .

Note ·

This is to make sure that the probe tip and filter do not influence the probe test, and that the test cavity is not contaminated.

Otometrics

Test cavity for probe check

2. Select

Menu > Probe Check

.

3. Insert the probe tip without eartip in the test cavity in the charger. The probe check starts automatically.

The probe is checked for occlusion and leakage. If the probe is OK, the probe is automatically calibrated to 2cc.

Note ·

In case of a probe error, check the following:

57

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

• Make sure that the threaded ring holding the probe tip in place is firmly tightened.

• Make sure that the sound channels in the probe tip are clear and that the probe is connected.

• Check that the altitude setting (

Menu > Advanced.. > Device settings.. > Altitude ab. sea

) corresponds with your geographical location as the barometric pressure may influence the admittance readings).

If the probe should be faulty, contact your authorized service department for repair, and use another probe, if available.

Note ·

If your test environment changes, for instance if there is an increase in humidity, or if you are going to test at an altitude different from the one set in OTOflex 100, adjust the altitude setting and make another probe check.

6.3.4

Selecting patient folder and test type in OTOflex 100

Patient folders

A Patient Folder contains the test results saved during testing in one single session, and refers to all the test results and sub-test data of a specific patient.

OTOflex 100 automatically creates a new patient folder when you switch on

OTOflex 100. You can create more than one folder for each patient if required.

If you have to interrupt testing of a patient, you can resume testing within the same

date by selecting the patient’s specific folder.

With NOAH

If you are using OTOflex 100 with the Immittance Module and NOAH, and you have created a new Patient, the patient’s name is downloaded from NOAH to

OTOflex 100.

• To learn more about the communication between OTOflex 100, OTOsuite and

NOAH, see

11 Data management in MADSEN OTOflex 100  131 .

OTOflex 100 Stand-alone

If you are using OTOflex 100 stand-alone, without communicating with the Immittance Module, a new patient folder is created automatically when you switch on

OTOflex 100.

• You will be prompted for patient and user info if

Menu > Procedure Options >

Patient prompt

is

On

.

58

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

Creating a new patient

Depending on your setting in the Quick flow setup (

6.3.5 Test flow setup  59 ) a

new patient is created automatically when you switch on OTOflex 100. If required, you can also create a new patient.

Entering patient and user information

In OTOflex 100

• Use the text editor to enter patient related information when prompted or select

Menu > Patient & User..

• If OTOflex 100 has been switched off and you wish to continue a test, select

Menu > Manage Test Results.. > Load Patient

.

• If required, use the

Test Selector

to select the appropriate test type. See

3.2.2 Test Selector mode  27 .

• Perform the required tests.

• The test data is saved as a Patient Folder including the current patient’s data.

• When OTOflex 100 connects with OTOsuite, you will be prompted to synchro-

nize data, if required. See 8.5 Communicating and synchronizing with

OTOsuite  102

.

In OTOsuite

You can enter patient and user information in the Client Details dialog in OTOsuite.

This information is then used in printed reports, and can be saved in OTOflex 100.

• Press

Crtl + D

or select

Edit > Client Details..

Selecting an existing patient in OTOflex 100

• Select

Menu > Manage Test Results.. > Load Patient..

, scroll to the required patient’s folder and press

Select

.

6.3.5

Test flow setup

1. A new patient folder is created automatically when you switch on OTOflex 100.

2. The

Patient & User..

screen appears. Enter the data related to the patient and

user. See 3.2.3 The Text Editor  29 ).

3. Set up your OTOflex 100 to facilitate the entire process of testing, handling patient info, and continuing with the next patient:

– Select

Menu > Procedure Options.. >

“Done?”

prompt  set to

On

If you select

On

, the

“Done?”

prompt will appear when you have finished testing a patient, i.e. when you have performed the same number of tests on both ears.

Otometrics

59

Preparing OTOflex 100 and the Immittance Module for testing

Preparing OTOflex 100

Print when done?

set to set to

On

“Patient”

set to

On

“Setting”

On

prompt 

prompt 

 If the

“Done?”

prompt is set to

On

, and you press

Yes

in response to the prompt, the results will be printed (see

9 Printing  105

).

When printing is done, the

“Done?”

prompt reappears. If printing was successful, select

Yes

to continue.

OTOflex 100 creates a new patient folder.

If the

“Patient”

prompt is set to

On

, the

Patient

& User

screen for entering patient data appears when a new patient folder is created.

When you have entered patient data, the

Load

Settings

screen appears if any customized settings are available.

Select the test settings of your choice, and continue with testing.

4. If required, select the appropiate test type by pressing repeatedly on the

ON/OFF button. See 3.2.2 Test Selector mode  27 .

5. Perform the required tests. See

7 Testing with MADSEN OTOflex 100  67

.

6. The test data is saved as the current patient’s data.

6.3.6

Users

If several users are using OTOflex 100, you can select a user for the session, or create a new user. This will be reflected in the various reports. User selection in

OTOflex 100 is not reflected in personalised settings and protocols.

Selecting a user

• Select

Menu > Patient & User

.

• Scroll to the

User

field and press

Select

to access the field.

• Turn the

Scroll wheel

to view the various users available and press

Select

to choose.

If you are using OTOflex 100 with OTOsuite, you cannot access the Patient &

User screen. Patient and user information is determined by OTOsuite.

• If the user does not appear on the list, you can create the user. See Creating a user  61 .

If you are using OTOflex 100 as a stand-alone device, the list shows only the users you have entered in OTOflex 100.

60

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing the patient

6.3.6.1

Creating a user

1. If you wish to create a new user in the user list of OTOflex 100, select

Menu >

Advanced > Users.. > Create New User..

and press

Select

.

2. Enter the appropriate data (max. 3 characters). See

3.2.3 The Text Editor  29 .

3. When you have entered the appropriate data, press

OK

.

Deleting a user

1. If you wish to delete a user from the user list of OTOflex 100, select

Menu >

Advanced > Users.. > Delete User..

and press

Select

.

2. Scroll to the appropriate user and press

Select

to delete. See

3.2.3 The Text

Editor  29

.

Selecting ear to be tested in OTOflex 100

Regardless of the type of test you have selected in OTOflex 100, you must select the ear on which you wish to start the test.

• In OTOflex 100 you can select the first ear to be tested:

Menu > Procedure options > First ear to test

. Press

Select

to toggle.

or

• Toggle the

Ear selector

key on the keypad until the

Ear icon

on the screen shows the probe ear.

6.4

Preparing the patient

6.4.1

Fitting the eartip on the probe

Warning ·

Choking hazard! Do not leave eartips unsupervised within the reach of children.

You can choose between various types of eartips, depending on the type of test you wish to do:

• Screening eartips

• Regular eartips

• Infant eartips

1. Check the sound channels in the probe tip every time you have used the probe.

Even small amounts of cerumen or vernix can block the sound channels. Clean the sound channels if required.

2. Select an ear tip that fits the patient’s ear canal. You may have to try out a number of sizes in order to select the appropriate size.

Otometrics

61

Preparing OTOflex 100 and the Immittance Module for testing

Preparing the patient

C

B

C

B

A

A

3. Gently push and twist the eartip (A) onto the probe tip, until it rests firmly against the base of the probe (B). Make sure that the eartip covers the collar (C) of the probe tip.

Note ·

Accurate testing is only guaranteed if you use the eartips designed specifically for

OTOflex 100 by Otometrics.

Note ·

The eartip can be used for both ears. However, if you suspect infection in one ear, exchange the eartip and clean the probe tip before you continue testing on the other ear.

6.4.2

Fitting the probe in the patient’s ear

Note ·

This procedure does not apply to screening eartips, which should simply be held firmly against the ear canal opening of the patient.

Inspecting the patient’s ear

1. Position the patient so that you can easily access the ear to be tested.

2. Grasp the pinna and gently pull back and slightly away from the patient's head.

3. Look into the ear canal. It is strongly recommended that you perform an otoscopy to assess the status of the outer ear before you insert the probe.

If you can see apparent narrowing of the ear canal, it may be blocked by vernix or debris, or it may not be straight.

Note ·

Because infants’ ear canals are very soft, they are easily pressed out of shape.

If this is the case, wait until the ear canal returns to its original shape. Release the pinna and try again. Gently massaging the area may help opening the ear canal.

4. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if required.

Fitting the eartip in the ear of the patient

Warning ·

Be careful not to insert the probe too far into the ear canal of premature babies and newborns.

Caution ·

Never insert the probe without a proper size ear tip applied. Using a probe with an unsuitably sized eartip or applying excessive force may irritate the ear canal.

62

Otometrics

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing the patient

6.4.2.1

1. To fit the probe eartip in the ear canal of the patient, grasp the pinna and gently pull the pinna back and slightly away from the patient's head, and insert the probe in the patient’s ear canal, twisting the eartip slightly as you insert it.

2. Make sure that the eartip fits well. Any leakage may interrupt the test. During testing, OTOflex 100 and the Immittance Module will show a probe icon indicating probe fit. See

6.4.3 Leakage  64 .

To compensate for spontaneous movements of the patient’s head:

– Place the probe cable behind the patient’s neck.

– To keep the cable in place, place a weighted shoulder harness over the cable, from front to back of the patient, across the shoulder opposite the ear being tested.

– Make sure that the cable is not drawn tight, as this may result in the probe being pulled out of position.

Note ·

The eartip can be used for both ears. However, if you suspect infection in one ear, exchange the eartip and clean the probe tip before you continue testing on the other ear.

See

14.3.2 Probe cleaning and maintenance

192

.

Fitting the Ipsi probe in the ear canal

Warning ·

Be careful not to insert the probe too far into the ear canal of premature babies and newborns.

1. Position the patient so that you can easily access the ear to be tested.

2. Inspect the ear canal. To do so, grasp the pinna and gently pull back and slightly up and away from the patient's head.

Note ·

If the patient is a newborn, gently pull the pinna down and back. For older infants, pull the pinna up and back.

3. Look into the ear canal.

If you can see apparent narrowing of the ear canal, it may be blocked by vernix or debris, or it may not be straight.

Note ·

Because the ear canals of newborns are very soft, they are easily pressed out of shape.

If this is the case, wait until the ear canal returns to its original shape. Release the pinna and try again. Gently massaging the area may help opening the ear canal.

4. If the ear canal is blocked, this will affect the result of the test. Clean the ear canal if required.

63

Preparing OTOflex 100 and the Immittance Module for testing

Preparing for the next patient

5. Insert the probe with the eartip in the patient’s ear canal.

6.4.3

Leakage

Testing may be complicated by a number of factors which can result in leakage or probe problems. Leakage can for instance be caused by:

• badly fitting eartips,

• eartip not inserted properly in the ear canal,

• ear canal debris blocking for proper ear tip seal,

• old, hardened eartip,

• pneumatic probe plug not inserted properly in OTOflex 100,

• threaded ring holding probe tip not tightened properly.

Probe problems may be caused by:

• an occluded probe,

• a blocked wax filter.

Leak detection

If there is leakage or if the probe is blocked during testing, it is indicated in

OTOflex 100 and the Immittance Module by one of the leak icons below.

The Immittance

Module

OTOflex 100

Probe OK

Probe BLOCKED

Probe LEAK

Probe NOT

INSERTED

• Adjust the position of the probe or clean the probe and continue testing.

6.5

Preparing for the next patient

When you have finished testing a patient and wish to test a new patient:

1. For the sake of patient privacy, when you receive a new patient make sure that the screen does not show any information about the patient you just finished testing.

64

Otometrics

Preparing OTOflex 100 and the Immittance Module for testing

Preparing for the next patient

2. If you have set

Menu > Procedure options > Patient prompt

to On,

OTOflex 100 will present the Patient and User info screen as part of the ‘Done’

action sequence (see 6.3.5 Test flow setup  59 ).

3. Enter the patient’s name and date of birth to identify the data on the single page

report. See 6.3.4 Selecting patient folder and test type in OTOflex 100  58

.

If you do not enter these patient-specific data, you can write them in the blank fields on the printed report afterwards.

4. If required, use the

Test Selector

or press

On/Off

briefly to select the appropriate test type. See

3.2.2 Test Selector mode  27

.

5. Perform the required tests.

6. The test data is saved as the new patient’s data.

Otometrics

65

Preparing OTOflex 100 and the Immittance Module for testing

Preparing for the next patient

66

Otometrics

7

7.1

Testing with MADSEN OTOflex 100

This section describes how you perform tests using MADSEN OTOflex 100.

For descriptions on how to test using the Immittance Module see

10 Testing with the

OTOsuite Immittance Module  107

.

Fast diagnostics - the quick approach

1*

Patient & User

First Name:

Last name:

Birth Date (D-M-Y)

__ -__ - ____

Gender:

User: ABC ok

Load Settings

Infant

Adult

2*

Cancel ok

Enter patient info

Select User

3

R

Select settings

(test protocol)

4 5

L

( )

Switch ear

Insert contra then probe.

Start sequence

(auto or manual

( )

Insert contra then probe.

Start sequence

(auto or manual

Otometrics

67

Testing with MADSEN OTOflex 100

General test softkeys and shortcuts

L

6*

Done ?

no yes

7*

L

Done ?

no yes

Confirm testing done

Direct printout Confirm report ok

& testing done

7.2

General test softkeys and shortcuts

Left softkey

68

Right softkey

On/Off

Next test

Ear Selector

Select

Softkeys

Left

Scroll wheel

The current functions of the two softkeys are shown at the bottom of the screen, just above each softkey.

Press and hold

to view patient and user information.

During testing

Pressure release

Press for immediate release of air pressure and stop/pause of measurement.

Between measurements

Ear selection

Press to toggle the ear selection associated with the current measurement

Otometrics

Scroll wheel

Testing with MADSEN OTOflex 100

Start testing

On/Off

Press and hold to turn the device on or off.

Toggle test type

Press briefly to toggle between test types.

Turn the scroll wheel to shift the focus on the screen, change values and control pressure:

Select

Press and hold to activate the Test Selector (see

3.2.2 Test Selector mode  27

)

Activate item

Press to activate the selected item, to accept a selected value and to toggle values.

7.3

Start testing

1. When you switch on OTOflex 100, you are first presented with the

Patient &

User

screen.

2. Use the

Text Editor

to enter patient information (

3.2.3 The Text Editor  29 ).

3. When you have entered patient information, press or

OK

to go

– to the

Load Settings

screen (if enabled in

Menu > Procedure Options >

‘Settings’ prompt

), or,

– directly to the test screen with the OTOflex 100 in test mode.

4. Use the

On/Off

button to toggle to the next test.

5. You are now ready to start testing.

7.4

Sequence testing

A test sequence is a predefined set of automatic tests which can be performed automatically.

OTOflex 100 will always perform the most recently selected sequence, regardless of whether it has been selected in the Immittance Module or in OTOflex 100.

Note ·

The Reflex Thresholds are included in the test sequences in order to measure Reflex

Decay, since the decay stimulus levels are based on thresholds.

7.4.1

Selecting a test sequence

• Select the appropriate test sequence:

– OTOflex 100:

Menu > Procedure Options.. > Sequence

Otometrics

69

Testing with MADSEN OTOflex 100

Screening

– The Immittance Module: In the

Sequence

field below the

Navigation Panel

click the drop-down list to select.

T + RS (Tympanometry + Reflex Screening)

Practical for basic hearing assessment.

T + RT

(Tympanometry + Reflex Threshold)

For full diagnostic hearing evaluation.

T + RT + RD

(Tympanometry + Reflex Threshold + Reflex Decay)

For full diagnostic hearing evaluation with suspicion of retrocochlear disorder.

7.4.2

Running a test sequence from OTOflex 100

• Press and hold the right softkey to start the sequence.

In test mode you can always see which sequence is selected in the top line of the test screens.

Note ·

The sequence starts as soon as probe seal is achieved if

Menu > Procedure options > Auto start on seal

is set to

Sequence

.

Warning ·

If the patient is troubled by the test, stop the test:

Press the

Pressure Release

key on OTOflex 100.

If a leak is detected or the probe is removed from the patient's ear, the sequence is automatically paused (a sequence can also be paused manually). The sequence can then be stopped or it can be resumed after a seal has been reestablished.

• If

Menu > Procedure options > Auto resume on seal

is On:

If the probe is removed from the patient’s ear or in case of leakage, the sequence will automatically resume from the pause state when the seal is reestablished.

When resumed, a sequence will always continue from where it was paused. An interrupted reflex stimulus will be repeated.

Note ·

If the leak appears during the tympanometric measurement, the tymp part of the sequence will not be repeated. Press

Stop

and restart the sequence if you need to repeat the tympanometric measurement.

7.5

Screening

Note ·

Use screening eartips for screening.

70

Otometrics

Testing with MADSEN OTOflex 100

Screening

7.5.1

Screening tympanometry

Start

1. Load a test setting configured for screening patients in the relevant age group.

See recommended settings below.

2. Press

Start

without applying the eartip to the patient’s ear.

3. Apply the probe to the patient’s ear with a steady grip.

4. The test starts automatically as soon as a good probe fit with an airtight seal is achieved.

Settings - Screening tympanometry

When you perform screening tympanometry, the following settings make this test even quicker:

Auto start on seal (Menu > Procedure options.. >

)

Tymp (default: Off ).

Pump speed (Menu > More Settings.. >

)

AFAP (default infant: AFAP; default adult: 200 daPa/s).

Stop when results (are available) (Menu > More Settings.. >

)

On (default: Off ).

7.5.2

Reflex screening

Note ·

In screening mode the safety intensity level cannot be exceeded.

Note ·

If you are performing a Tympanometry + Reflex Screening autosequence, using screening eartips and with

Menu > Procedure Options.. > Auto start on seal

set to

On, the test will start with Tympanometry testing and continue automatically from

Tympanometry to Reflex Screening.

Otometrics

71

Testing with MADSEN OTOflex 100

Screening

7.5.2.1

Screening mode

Softkeys

Left

Right

Functions

Press and hold to display patient and user info

Press

to start test.

Press and hold

to start sequence.

Steady

: Press to pause test.

Flashing

: Press to continue.

Press

to stop test.

72

Start

If Auto start on seal is

OFF

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press the

Stop

or

Pause

softkey, or the

Ear Selector/Pressure Release

key on the keypad to stop the test. The test is interrupted immediately. Already measured results are kept.

1. You can either perform Reflex Screening using ordinary eartips, or using screening eartips.

If you use screening eartips, it is recommended that you use the setting

Menu >

Procedure Options.. > Autostart on seal

set to Sequence. When a good probe fit with an airtight seal is achieved, i.e. when the screening eartip is pressed gently against the ear, testing will start with a tympanometric test and continue with this test.

2. Ask the patient to sit very still and quiet during this test, without moving head or jaw.

3. Hold the probe with a steady grip to prevent probe movements from resulting in leakage or changes in admittance.

Otometrics

Otometrics

Testing with MADSEN OTOflex 100

Screening

7.5.2.2

4. If required, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

5. If contralateral stimulation is included, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL. See also

7.8 Acoustic reflex testing

81 .

– If required, press the

Pause

softkey to interrupt the test. Press the flashing

Pause

softkey to resume. After the pause OTOflex 100 continues from the intensity it came to or was interrupted in.

The reflex screening result

1. Press

On/Off

briefly to select the Reflex Screening test screen.

The deflection curves of the included intensities are shown in the graphs for the highlighted stimulus. Individual stimulus intensity and admittance change are listed below each graph.

Selected test setting

Selected test and frequency

The initial reflex screening test screen with ipsilateral 1 kHz stimulus highlighted.

As indicated by the

Start

softkey, the screening is automatically performed for all preset stimuli.

73

Testing with MADSEN OTOflex 100

Screening

74

Reflex Screening test result, where the result field for contralateral BBN is highlighted, and the curve and values for this stimulus type are shown. Reflexes are found for 1 kHz contralateral stimulus and BBN ipsilateral stimulus. Reflexes are absent for

1 kHz ipsilateral and BBN contralateral stimuli.

Field results

The deflection curves of the included intensities are displayed in the graphs for the highlighted stimulus. Individual stimulus intensity and admittance change are listed below each graph.

*

Check-marks or hyphens indicate whether a reflex has been detected or not. This applies when the measurement setting

Menu

> More settings > No. of intensities

is set to 1.

Numerical values or crossed out numerical values indicate whether a reflex has been detected or not. This applies when the measurement setting

Menu > More settings

> No. of intensities

is set to more than 1.

Blank cells indicate that the test has not been performed.

Changing view settings

No view settings apply to the Reflex Screening test.

7.5.3

Settings - Screening

• Menu > Procedure Options.. > Auto resume on seal

Off:

The screening eartip must remain in place against the patient’s ear. If the probe is removed, the test is interrupted.

Otometrics

7.6

Testing with MADSEN OTOflex 100

Tympanometry

On: 

If the screening eartip is removed from the patient’s ear, the test continues from the intensity it came to or was interrupted in, when there is seal.

Auto start on seal (Menu > Procedure options.. >

)

On.

Max. intensity (Menu > More Settings.. >

)

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL.

No. of intensities (Menu > More Settings.. >

)

1 intensity.

Check marks or dashes not.

indicate whether a reflex has been detected or

2 or 3 intensities.

Numerical values or crossed out numerical values indicate whether a reflex has been detected or not.

Intensity increment (Menu > More Settings.. >

)

Step in dB between each stimulus intensity presented. If e.g. the increment is set to 10 dB and the number of intensities is set to 2, the first presentation will be at the max intensity -10 dB.

Tympanometry

Note ·

You should always conduct a tympanometric test before making any acoustic reflex measurement. Also, you should always establish the acoustic reflex threshold before making a reflex decay measurement.

Otometrics

75

Testing with MADSEN OTOflex 100

Tympanometry

7.6.1

Tympanometry softkeys and shortcuts

Left softkey

Right softkey

On/Off

Ear Selector/

Pressure

Release

Scroll wheel

Select

Softkeys

Left

Right

Functions

Press

to choose between 3 tympanometry test results

(the number and curve currently shown are highlighted).

Press and hold

to display patient and user info

Press

to start tympanometry sweep.

Press and hold

to start sequence.

Press

to stop tympanometry sweep.

7.6.2

Diagnostic tympanometry

The default setup available in the tympanometry test is designed for any of the tympanometry tests you can perform.

To make a Tympanometry test:

1. Fit the patient with the probe.

2. Press

Start

to start the Tympanometric measurement.

76

Otometrics

Testing with MADSEN OTOflex 100

Tympanometry

Start

Warning ·

If the patient is troubled by the test, stop the test:

Press the

Pressure Release

key on OTOflex 100.

3. The test progresses as follows:

– The pump increases the pressure to the maximum value defined in

Menu >

More Settings.. > Pressure range

and depending on

Menu > More Settings.. > Sweep direction

.

– As soon as the predefined pressure has been reached, the sweep starts.

As the sweep progresses, the admittance for each pressure point is plotted out on the screen and forms the tympanogram curve. During the measurement, there are two diamond markers:

– an admittance marker just to the right of the admittance axis, indicating the current admittance, and

– a pressure marker below the pressure axis, indicating the current pressure.

Otometrics

Tympanometric test results are shown in a results view: Use the

Test Selector

and scroll to the Tympanometry Results screen, or press

On/Off

briefly. To display additional results, press

Select

for 1 second. To return to the standard tymp view, press again.

77

Testing with MADSEN OTOflex 100

Tympanometry

4. To make a new sweep, press the

Start

softkey.

You can save up to 3 separate measurements for each ear in a Patient Folder.

5. When you have finished testing, switch ears, if required:

Press the

Ear Selector

key on OTOflex 100.

6. To continue testing, press

Start

and test the other ear.

7. When you have finished testing, go to

8.1 When testing is done  101

.

7.6.3

The diagnostic tympanometry result

The Tympanometry test screen provides the tympanometric curves, norm area, the resulting Type, TPP, and ECV/EBV. All other tympanometric results are shown in the Tymp Data screen.

Note ·

The probe tone shown in the test screen applies to the currently selected measurement setting, and may not reflect the probe tone setting that was used for the curve shown.

The actual probe tone applying to the curve shown can be found in the Tymp Data screen (press

On/Off

briefly to scroll to the Data screen).

The Tympanometry graph shows a maximum of 3 curves per ear per patient, either all at once as layered curves, or individually.

• Use the

Curve Selector

( 3.2.4 The Tympanometric Curve Selector  30 ) to

select a specific curve for viewing.

The results for the highlighted curve are displayed.

78

7.6.3.1

Changing view settings

You can change the following view settings to customise your view. None of these settings influence the test data as such.

Otometrics

Testing with MADSEN OTOflex 100

Tympanometry

7.6.3.2

Menu > Baseline comp(ensation)

Menu > Tymp scale

Menu > Layered curves

Menu > More Settings > Pressure range

Menu > More Settings > Tymp auto scale

Menu > More Settings > Norm type

Menu > More Settings > Show norm area

The Tymp Data screen

If required, press

On/Off

briefly to select the Tymp Data screen.

Otometrics

The results shown in the Tymp Data screen reflect the curve currently selected in the

Tympanometry test screen.

The following features are described in detail in App. 2.2.2 Tympanometric features  223

.

• Tympanometric Peak Pressure, TPP

• Static Admittance, SA (Static Compliance, SC, when volume units are used)

• Tympanometric Width, TW

• Equivalent Ear Canal Volume, ECV (Equivalent Baseline Volume, EBV, when

1000 Hz probe tone is used)

• Tympanometry type, “Type”

• Probe tone, P, in Hz

• Press

Select

briefly to return to the standard tymp screen.

79

Testing with MADSEN OTOflex 100

ETF-I (Eustachian Tube Function - Intact)

7.6.4

Settings - Diagnostic tympanometry

The Tympanometry graph shows a maximum of 3 curves per ear per patient. To select/deselect automatic curve increment, select

Menu > More Settings.. > Auto next curve

.

Off

Recorded tympanograms will always be stored in the selected curve number overwriting any previous graph in that curve memory. You must manually advance the curve number to preserve a previously recorded tympanogram.

On

Every time a new measurement is initiated, the curve number is advanced automatically before the tympanogram is recorded (except if the current curve memory is empty). In this way, the first 3 tympanograms recorded are automatically stored. If you continue measuring, the curve number is cyclically increased and older tympanograms overwritten.

7.7

ETF-I (Eustachian Tube Function - Intact)

1. Record a tympanogram.

2. Instruct the patient to perform either Valsalva’s or Toynbee’s maneuvers.

3. Advance to the next curve number.

4. Record a second tympanogram.

5. Compare the tympanograms from step 1 and 3 in a multilayered tympanogram.

80

It may be useful to repeat the procedure using different techniques and maneuvers in a sequence of testing to fully evaluate the functioning of the Eustachian tube.

7.7.1

Settings - ETF-I

• Menu > More Settings.. > Auto next curve

Otometrics

7.8

Otometrics

Testing with MADSEN OTOflex 100

Acoustic reflex testing

– If

Menu > More Settings.. > Auto next curve

is Off, a new tympanometric measurement will always be made to overwrite the currently selected curve.

You must manually switch curves if you want to preserve the curve you just made before making a new one.

– If

Menu > More Settings.. > Auto next curve

is On, a new tympanometric measurement will be made in the NEXT curve unless you manually select a curve.

When viewing ETF-I results, the following view setting is useful:

• Select

Menu > Layered curves >

On.

Acoustic reflex testing

Note ·

You should always conduct a tympanometric test before making any acoustic reflex measurement and establish the acoustic reflex threshold before making a reflex decay measurement.

The easiest way to measure acoustic reflexes is by using the automatic or semi-automatic test features provided by the OTOflex 100. Manual editing and testing is also possible for specific stimulus intensities.

When reflexes are tested using these automatic or semi-automatic features, the reflexes are automatically determined using different stimulus levels. These levels are predefined, but can be adjusted. It may be necessary to customise the settings relating to automatic testing. These settings are found in:

Menu > More Settings.. > Auto

Settings..

High intensity levels

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL. When testing the stimulus types between

500 and 2000 Hz, reflexes not found at this intensity are considered abnormally elevated (using a 2-standard deviation criterion from the average threshold level in adults).

Whenever a stimulus level exceeds the warning level (> 108 dB SPL re 2 cc corresponding to >=115 dB SPL in 0.5 cc), the stimulus intensity value will start flashing and automatic testing is paused. You are then prompted to decide whether to continue or to move on to the next stimulus type.

Caution ·

When you test on small ears, the sound pressure level will increase in the ear canal. It is therefore not recommended to exceed the warning level when testing on patients with small ear canals.

81

Testing with MADSEN OTOflex 100

Reflex Threshold testing

Measurements saved

OTOflex 100 automatically keeps the last 3 deflection curves measured.

When saving in NOAH, up to 52 individual reflex deflection curves (screening, threshold and decay) are saved. Priority is given to deflection curves documenting increasing deflections with increasing stimulus intensity above the threshold.

7.9

Reflex Threshold testing

Semi-automatic testing:

Start stimulus, Threshold search at one frequency only

Automatic testing:

Start stimuli, Threshold search at all programmed stimulus frequencies

Select

Activate manual testing mode for highlighted stimulus frequency

Scroll wheel

Select stimulus level

Select stimulus type and presentation side (ipsi/contra)

82

Automatic testing

• Press

Start stimuli

to start automatic testing.

Runs a fully automatic threshold search on all pre-programmed stimuli (

Menu >

More Settings > Auto Settings

). See

7.9.2 Automatic and semi-automatic

Reflex Threshold testing  84 .

Semi-automatic testing

• Press

Start stimulus

to start semi-automatic testing.

Performs an automatic threshold search for the currently highlighted stimulus type/side. See

7.9.2 Automatic and semi-automatic Reflex Threshold testing  84 .

Manual

• Press

Select

to activate manual mode.

Activates the currently highlighted stimulus type/side for manual testing. See

7.9.5 Manual Reflex Threshold testing  88

.

Before reflex testing:

1. Warn the patient about the high stimulus levels in the test, and ask the patient to sit very still and quiet during this test, without moving head or jaw.

2. If contralateral stimulation is included, make sure that both Ipsi probe and Contra insert phone are in place.

Otometrics

Testing with MADSEN OTOflex 100

Reflex Threshold testing

7.9.1

Keys and functions

7.9.1.1

Idle mode functions

Softkeys

Left

Right

Scroll wheel

Select

Functions

Press

to run semi-automatic test (see below)

Press and hold

to display patient and user info

Press

to start auto test (see below)

Press and hold

to start sequence.

Select stimulus type and side (moves between preset settings only). Allows the user to skip the rest of the intensities for current stimulus type in pause mode.

• If stimulus types, I(psi) or C(ontra) are in focus, press to activate manual mode.

• If the

Menu

icon is in focus, press to access

Menu

.

7.9.1.2

Automatic and semi-automatic softkey functions

Softkeys

Left

Right

Select

Functions

Stop

stimulus.

Press and hold

to display patient and user info

Steady

: Press to pause test.

Flashing

: Press to continue.

Return to idle mode

Otometrics

83

Testing with MADSEN OTOflex 100

Reflex Threshold testing

7.9.1.3

Manual mode functions

Softkeys

Left

/

Right

Scroll wheel

Select

Functions

Mark/ClearMark

. Available only if test for stimulus/intensity has been performed

Press and hold

to display patient and user info

Start

stimulus. If safety intensity level is > safety limit: request confirmation to continue anyway

Stop

stimulus.

Select intensity. Flashing value indicates intensity warning (>108 dB SPL in 2 cc)

Return to idle mode

Note ·

This test is available only if OTOflex 100 supports diagnostic testing.

Warning ·

Tell the patient that the test involves high stimulus levels which are used to elicit the reflex. If the high sound levels are unacceptable to the patient, you may have to abort testing.

7.9.2

Automatic and semi-automatic Reflex Threshold testing

Semi-automatic testing:

Start stimulus, one level

Activate manual testing mode

Automatic testing:

Start stimuli, all selected levels

Scroll wheel

Select stimulus level

Select stimulus type and presentation side (ipsi/contra)

1. Press

On/Off

briefly to select the Reflex Threshold test screen.

84

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Testing with MADSEN OTOflex 100

Reflex Threshold testing

Otometrics

The initial reflex threshold test screen with ipsilateral 1 kHz stimulus highlighted.

The dashed horizontal line in each graph indicates the predefined reflex criterion. It is therefore offset from the base line marker on the vertical axis. The degree of offset is influenced by the setting in

Menu > More Settings > Reflex criterion

.

2. If required, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

3. Ask the patient to sit very still and quiet during this test, without moving head or jaw.

4. If contralateral stimulation is included, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

5. To start testing:

Start semi-automatic testing: use the

Scroll wheel

to select the stimulus (frequency and ipsi/contra) to be tested and press the

Start stimulus

softkey to start a semi-automatic reflex threshold search for the selected stimulus.

Start automatic testing: press the

Start stimuli

softkey to start a fully automatic reflex threshold search for all preset stimuli.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press the

Stop

or

Pause

softkey, or the

Ear

Selector/Pressure Release

key on the keypad to stop the test. The test is interrupted immediately. Already measured results are kept.

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus levels when reaching the warning limits, it is recommended that you set the max.

intensity to 95 dB HL. See also 7.8 Acoustic reflex testing

81 .

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Testing with MADSEN OTOflex 100

Reflex Threshold testing

6. To pause the test, if required, press

Pause

.

To resume testing, press the flashing

Pause

.

After the pause OTOflex 100 continues from the intensity it came to or was interrupted in.

If

Auto resume on seal

is On, testing resumes when probe fit is good.

– If a threshold is not found immediately, the stimulus intensities will increase until a reflex threshold is registered or until the max. intensity is reached.

– If a threshold is found immediately, the test will automatically decrease the stimulus intensities until a threshold is no longer registered.

7.9.3

Viewing Reflex threshold results

The test screen

86

Reflex Threshold test result, showing the three deflection curves for the highlighted

1 kHz ipsilateral stimulus. Manually changed thresholds are marked with an asterisk.

The dashed horizontal line indicates the predefined reflex criterion.

Field results

If the field simply shows a value with no extra marks, the threshold has been determined automatically.

If the field is crossed out, this indicates that no threshold has been detected at this highest test level.

If the field is marked by an asterisk, the threshold has been manually determined.‘

If a field is blank, this indicates that the test has not been performed.

Otometrics

Testing with MADSEN OTOflex 100

Reflex Threshold testing

The dashed horizontal line in each graph indicates the predefined reflex criterion. It is therefore offset from the base line marker on the vertical axis. The degree of offset is influenced by the setting in

Menu > More Settings.. > Reflex criterion

.

Changing view settings

You can change the following view settings to customise your view. This setting does not influence the test data as such.

Menu > More Settings > Deflection scale

Menu > More Settings >

- Show 500 Hz

- Show 1000 Hz

- Show 2000 Hz

- Show 3000 Hz

- Show 4000 Hz

- Show BBN

- Show LBN

- Show HBN

If there is test data for a frequency, it will be shown anyway.

7.9.4

Settings - Automatic and semi-automatic Reflex Threshold

When testing automatic reflex threshold, the following settings are useful:

Auto resume on seal (Menu > Procedure options.. >

)

Off

If there is a probe leak, the test is interrupted. You must resume testing manually if testing is paused due to a leak.

On

Testing resumes automatically when a proper seal is obtained if testing was paused due to a leak.

Custom TPP offset (Menu

)

On

The pressure is offset from the TPP by the TPP offset defined in

Menu > More settings > TPP offset

. If the offset is set to a value with the post fix "more", it shifts the pressure in the same direction as the sign of the TPP, and in the opposite direction if it is set to "less".

Note ·

The TPP value from the most recent tympanometric curve at the same probe tone is used in reflex measurements.

Verification (Menu > More Settings.. > Auto Settings.. >

)

Depending on your settings, you can select the type of verification to be used:

The lowest stimulus intensity, where the reflex criterion was met, may be retested

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Testing with MADSEN OTOflex 100

Reflex Threshold testing

for reproducibility, or the next one or two intensity levels can be used to confirm the reflex growth properties.

7.9.5

Manual Reflex Threshold testing

If a threshold is not found during automatic or semi-automatic testing, you can test specific stimulus intensities manually:

Mark/Unmark

Select

Activate manual testing

Access stimulus level field

Exit manual testing

Start stimulus

All selected levels

Scroll wheel

Select stimulus level

1. Press

On/Off

briefly to select the Reflex Threshold test screen and press

Select

to activate manual test mode.

2. If required, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

3. Ask the patient to sit very still and quiet during this test, without moving head or jaw.

4. If contralateral stimulation is included, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

88

5. Scroll to select the stimulus intensity for a single presentation.

6. Press

Start stimulus

to present the stimulus.

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Testing with MADSEN OTOflex 100

Reflex Threshold testing

7. Mark the intensity with which you associate the threhold.

8. Adjust the intensitiy and press

Start stimulus

to present the stimulus.

9. Continue until you register the reflex threshold or until the max. intensity is reached.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press the

Stop

softkey, or the

Ear Selector/Pressure Release

key on the keypad to stop the test. The test is interrupted immediately. Already measured results can be saved.

10.The deflection curves are shown on the screen as the test progresses, resulting in a complete Reflex deflection graph.

The curves shown are always sorted according to increased stimulus intensity.

The measurement stops automatically at the end of each stimulus presentation.

11.If a threshold is not found, increase the stimulus intensity until a reflex threshold is registered or until the max. intensity is reached.

12.To test another level, use the

Scroll Wheel

to scroll to the next stimulus level and press the

Start stimulus

softkey.

13.Use the

Scroll Wheel

to scroll to the stimulus level to be reported as the threshold value, and press the

Mark/Unmark

softkey to select.

If no threshold is detected, the field is crossed out to indicate the absent threshold.

14.To make another test, for instance if the test result was not satisfactory, press the

Start stimulus

softkey to start a new test.

7.9.6

The Reflex Threshold results

If no threshold is detected/marked, the field is crossed out to indicate the absent threshold.

If you repeat a measurement at a specific intensity, the previous measurement for that intensity will be overwritten. As a consequence, you cannot see several curves with the same intensity.

7.9.7

Manually selecting/deselecting Reflex Threshold values

To manually select/deselect a threshold value:

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Testing with MADSEN OTOflex 100

Reflex Decay testing

Mark/Unmark

Select

Activate/Exit manual testing

Access stimulus level field

Scroll wheel

Select stimulus level

1. Use the

Scroll Wheel

to scroll to the stimulus level.

2. Press

Select

to access the field.

3. When you scroll in this field, OTOflex 100 displays the

Mark threshold

left softkey function for already measured stimulus intensities. Press the softkey to mark the intensity representing the threshold.

Likewise, press the

Unmark

softkey to deselect an already marked threshold.

The three curves (showing reflex responses) with the highest intensity where the threshold value has been detected are stored automatically by the system.

7.10

Reflex Decay testing

The decay test stimulus level pre-supposes that there is a reflex threshold available for the ear, stimulus type and stimulus ear (ipsi- or contralateral) that is chosen for reflex decay testing. The decay test stimulus level will then automatically be set to the threshold level +10 dB.

If no reflex threshold is available, the stimulus level is Off. This is useful for admittance monitoring.

For a maximum amount of monitoring time, set the

Menu > More Settings.. > Stimtime

setting to 26 seconds. The resulting curve can be saved as an ordinary decay graph.

Note ·

There may be a warning that the stimulus level is in the extended intensity range.

Reflex decay may not be possible due to highly elevated threshold levels.

Max. intensity levels

Ipsi

Contra

500 Hz

50 to 105 dB HL ± 3 dB

50 to 115 dB HL ± 3 dB

1000 Hz

50 to 120 dB HL ± 3 dB

50 to 120 dB HL ± 3 dB

90

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Testing with MADSEN OTOflex 100

Reflex Decay testing

7.10.1

Keys and functions

7.10.1.1

Idle mode functions

Softkeys

Left

Right

Select

7.10.1.3

Manual mode functions

Softkeys

Left

Right

Functions

Press and hold to display patient and user info

Press to start auto test (see below).

Press and hold to start sequence.

• If stimulus types, I(psi) or C(ontra) are in focus, press to activate manual mode.

• If the

Menu

icon is in focus, press to access

Menu

.

7.10.1.2

Automatic mode functions

Softkeys

Left

Right

Functions

Stop

stimulus and return to idle mode.

Press and hold to display patient and user info

Steady

: Press to pause test.

Flashing

: Press to continue.

Functions

Press and hold to display patient and user info

Start

stimulus. If the safety intensity level is greater than the safety limit, you will be prompted for confirmation to continue anyway.

Stop

stimulus.

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Testing with MADSEN OTOflex 100

Reflex Decay testing

Scroll wheel

Select

Select intensity (default value is reflex threshold +10 dB if measured, otherwise blank)

Return to idle mode

Before reflex testing

1. Warn the patient about the high stimulus levels in the test, and ask the patient to sit very still and quiet during this test, without moving head or jaw.

2. If contralateral stimulation is included, make sure that both Ipsi probe and Contra insert phone are in place.

7.10.2

Automatic Reflex Decay testing

Automatic testing:

Start stimuli, all selected levels

Select

Activate manual testing mode

Scroll wheel

Select stimulus level

Select stimulus type and presentation side (ipsi/contra)

1. If required, press

On/Off

briefly to select the Reflex Decay test screen. This screen opens up in automatic mode.

92

The initial reflex decay test screen with ipsilateral 1 kHz stimulus highlighted.

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Testing with MADSEN OTOflex 100

Reflex Decay testing

2. If required, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

3. If contralateral stimulation is included, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

4. Ask the patient to sit very still and quiet during this test, without moving head or jaw.

5. Press

Start stimuli

to start the test.

The thresholds are automatically determined for all preset stimuli.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press the

Stop

softkey, or the

Ear Selector/Pressure Release

key on the keypad to stop the test. The test is interrupted immediately. Already measured results can be saved.

6. To pause the test, if required, press

Pause

.

To resume testing, press the flashing

Pause

.

After the pause the test resumes at the intensity level during which the interruption occurred.

If

Auto resume on seal

is On, testing resumes when probe fit is good.

7.10.3

Settings - Automatic Reflex Decay

When testing automatic reflex decay, the following settings are useful:

Auto resume on seal (Menu > Procedure options.. >

)

Off

If there is a probe leak, the test is interrupted. You must resume testing manually if testing is paused due to a leak.

On

Testing resumes automatically when a proper seal is obtained if testing was paused due to a leak.

Custom TPP offset

(

Menu >

)

On

The pressure is offset from the TPP by the TPP offset defined in

Menu >

More settings > TPP offset

. If the offset is set to a value with the post fix

"more", it shifts the pressure in the same direction as the sign of the TPP, and in the opposite direction if it is set to "less".

When changed in Acoustic Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting, but not vice-versa.

Note ·

The TPP value from the most recent tympanometric curve at the same probe tone is used in reflex measurements.

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Testing with MADSEN OTOflex 100

Reflex Decay testing

7.10.4

The Reflex Decay results

When the measurement is completed, the result fields show the detected half-life time for each stimulus.

94

Reflex Decay test result, showing the half-life time and the reflex decay curve for the

0.5 kHz contralateral stimulus. The unbroken line above the graph indicates the duration of the stimulus. The dashed line is the x-axis indicating the total duration of the measurement.

Field results

The result fields show the detected half-life time for each stimulus.

Changing view settings

You can change the following view setting to customise your view. This setting does not influence the test data as such.

Menu > More Settings > Deflection scale

Changing view settings

You can change the following view settings to customise your view. This setting does not influence the test data as such.

Menu > More Settings > Deflection scale

Menu > More Settings >

- Show 500 Hz

- Show 1000 Hz

7.10.4.1

Measurements saved

Since a reflex decay measurement typically is made using either ipsilateral or contralateral stimulus side (not both), only two measurements are saved, i.e. different stimuli and/or ipsi/contra.

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Testing with MADSEN OTOflex 100

Reflex Decay testing

7.10.5

Manual Reflex Decay

Note ·

The manual reflex decay test available in the OTOflex 100 Quick Check version cannot be remotely controlled from OTOsuite.

Start stimulus

Select

Activate manual testing mode

Scroll wheel

Select stimulus level

1. If required, press

On/Off

briefly to select the Reflex Decay test screen. This screen opens up in automatic mode.

2. If required, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

3. If contralateral stimulation is included, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

4. Ask the patient to sit very still and quiet during this test, without moving head or jaw.

5. Scroll to the appropriate stimulus type and press

Select

to activate manual test mode.

Otometrics

6. Scroll to select the stimulus intensity for a single presentation.

7. Press

Start stimulus

to start the test.

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Testing with MADSEN OTOflex 100

Reflex Decay testing

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press the

Stop

softkey, or the

Ear Selector/Pressure Release

key on the keypad to stop the test. The test is interrupted immediately. Already measured results can be saved.

8. Each measurement stops automatically at the end of each stimulus presentation.

9. To make another test:

– Use the

Scroll Wheel

to scroll to the next stimulus type and press

Select

.

– If required, scroll to adjust

Intensity

.

– Press the

Start stimulus

softkey to start the stimulus.

If you repeat a measurement for a specific stimulus type, the previous measurement will be overwritten. As a consequence, you cannot see several measurements for the same stimulus type.

Note ·

If a result field indicating the half-life time of an already measured stimulus is selected using the

Select

key, the stimulus level appears and the test can be overwritten with a new measurement.

7.10.5.1

Settings - Manual Reflex Decay

When testing manual reflex decay, the following settings are useful:

Custom TPP offset

(

Menu >

)

On

The pressure is offset from the TPP by the TPP offset defined in

Menu >

More settings > TPP offset

. If the offset is set to a value with the post fix

"more", it shifts the pressure in the same direction as the sign of the TPP, and in the opposite direction if it is set to "less".

When changed in Acoustic Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting, but not vice-versa.

Note ·

The TPP value from the most recent tympanometric curve at the same probe tone is used in reflex measurements.

7.10.5.2

Measurements saved

Since a reflex decay measurement typically is made using either ipsilateral or contralateral stimulus side (not both), only two measurements are saved, i.e. different stimuli and/or ipsi/contra.

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Testing with MADSEN OTOflex 100

ETF-P testing (Eustachian Tube Function - Perforated)

7.11

ETF-P testing (Eustachian Tube Function - Perforated)

7.11.1

Idle mode functions

Softkeys

Left

Right

Functions

Press and hold to display patient and user info

Press to run test (clear curve and wait for pump directions)

7.11.2

Pressure build functions

Softkeys

Right

Left

Scroll wheel

Softkeys

Right

Left

Positive pressure build functions (initial state, if “Initial pressure” is set to Pos.)

Pressure control

Press to automatically build up positive pressure until the first opening of the Eustachian tube or max. pressure is reached. The pressure control is automatically reversed after one of the two criteria has been reached.

Stop

and go to idle mode.

Press and hold to display patient and user info.

Optional method: Turn the scroll wheel clockwise to manually control the pump instead of using the pressure control softkeys.6

The manual pressure control works in accordance with the current softkey symbol.

After positive pressure build functions (initial state if

“Initial pressure” is set to Neg.)

Pressure control

Press to automatically build up negative pressure until the first opening of the Eustachian tube or max. pressure is reached. The pressure control is automatically reversed after one of the two criteria has been reached.

Stop

and go to idle mode.

Press and hold to display patient and user info.

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Testing with MADSEN OTOflex 100

ETF-P testing (Eustachian Tube Function - Perforated)

Scroll wheel

Optional method: Turn the scroll wheel counter-clockwise to manually control the pump instead of using the pressure control softkeys.

The manual pressure control works in accordance with the current softkey symbol.

7.11.3

The test

1. Use the

On/Off

button to toggle to the Tympanometry test screen.

2. Make a tympanogram to confirm the perforation. The resulting tympanogram curve will be flat, and the ear canal volume will be abnormally high because it

includes the volume of the entire middle ear. See 7.6.2 Diagnostic tympanometry  76 .

3. Press

On/Off

briefly to select the ETF-P test screen.

This screen shows results, if available, from a previous test.

98

Scroll wheel

Manual pressure build-up

4. Press

Start test

to start the test.

Start test

Automatic pressure build-up

Otometrics

Testing with MADSEN OTOflex 100

ETF-P testing (Eustachian Tube Function - Perforated)

5. Depending on the setting in

Menu > Initial pressure

, OTOflex 100 automatically builds up positive pressure until the first opening of the Eustachian tube or max. pressure is reached, as indicated by right softkey .

The pressure control is automatically reversed after one of the two criteria has been reached.

If the initial time scale value is exceeded during the measurement, the axis automatically expands by 10 second steps to a maximum of 60 seconds.

7.11.4

The ETF-P result

One curve per ear is saved.

The Immittance Module: To view the graphs, click the appropriate field text removed here at the bottom of the screen to view the Eustachian tube open and close pressures.

ETF-P test result, showing how the pressure changes throughout the measurement as the Eustachian tube briefly opens and closes.

The ETF-P test screen in OTOflex 100 provides a simple view for quickly assessing the Eustachian tube function. For more extensive analysis, retrieve the numerical pressure values using the Immittance Module ETF-P screen post-analysis tool.

Changing view settings

You can change the following view setting to customise your view. This setting does not influence the test data as such.

Menu > More Settings > Initial time scale

7.11.5

The Immittance Module post-analysis tool - ETF-P

In the Immittance Module you can adjust the time-pressure graphs manually, if needed:

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Testing with MADSEN OTOflex 100

ETF-P testing (Eustachian Tube Function - Perforated)

1. Click the line closest to the pressure value to be adjusted.

2. Click and hold the left mouse button on the line to move it to the desired position.

3. The corresponding values in the ETF-P table at the bottom of the screen change accordingly.

4. To delete a line, click on the line and press

Delete

on your keyboard.

5. To delete the entire measurement, click on the graph and press

Delete

on your keyboard.

Settings - ETF-P

When testing ETF-P, the following setting is useful:

Initial time scale

(

Menu >

)

The end time is always max. 60 seconds, but to facilitate viewing, you can set a lower initial time value, which will then be shown on the horizontal axis.

100

Otometrics

8 Managing Test Results in OTOflex 100

8.1

When testing is done

When you have tested both ears, OTOflex 100 will prompt you according to the settings selected as described in

6.3.5 Test flow setup  59

.

8.2

Swap ear results

If you have tested a patient with the wrong ear selected in OTOflex 100, you can swap the ear results so that they are assigned to the other ear.

You can swap ear results during a session or after a session. Swapping applies to all tests made on that patient.

• Select

Menu > Manage Test Results > Swap ear results

.

The results are now assigned to the other ear.

8.3

Delete measurements

8.3.1

Tympanometry

You can delete a single sub-test/curve performed, either from a multi-curve graph or a multiple-graph action from the grid.

All 3 test results are shown on the screen simultaneously.

1.

1 2 3

Toggle to select one of the curve or graph numbers in this icon group to view a specific curve or graph. The curve will then be highlighted.

2. To delete a curve, select

Menu > Manage Test Results > Del(ete) Sub-test..

8.3.2

Reflex Threshold

In Reflex Threshold you cannot delete a single curve, only a complete test including all the stimulus intensities for the selected stimulus type.

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101

Managing Test Results in OTOflex 100

Deleting Test Results

8.4

Deleting Test Results

Deleting current test

To delete the current test, select

Menu > Manage Test Results > Del(ete) Current

Test

.

Deleting individual patients

To delete the specific, individual patients, select

Menu > Manage Test Results >

Del(ete) Patient..

• Scroll to select the specific Patient and press

Select

to delete.

8.4.0.1

8.4.0.2

Deleting all printed patients

If you wish to delete all printed patients, select

Menu > Manage Test Results >

Del(ete) all printed patients

.

Deleting all patients

If you wish to delete all patients, select

Menu > Manage Test Results > Del(ete) all patients

.

8.5

Communicating and synchronizing with OTOsuite

When OTOflex 100 is within range of OTOsuite and you click the

Select Device

icon in the Immittance Module, it connects while the transfer is active and then disconnects. If online, it uses the already established connection.

When you click

Select Device

in the Immittance Module, the data are synchronized.

If it is not the same Patient Folder in the Immittance Module and OTOflex 100, you are prompted to select the Patient Folder you would like to continue with.

102

• Select from the dialog box shown.

Each test is identified by a timestamp, the patient name, gender, birthdate, the type of test done on a specific ear, and the name of the user who did the test.

Otometrics

Managing Test Results in OTOflex 100

Communicating and synchronizing with OTOsuite

The test types are abbreviated as in the following:

– T = Tympanometry

RT = Reflex Threshold

RS = Reflex Screening

RD = Reflex Decay

ETF-P = Eustachian Tube Function - Perforated

If data is already available in the Immittance Module, you are prompted to either overwrite the data or cancel.

8.5.1

Synchronizing data

Data is usually transferred from OTOflex 100 to OTOsuite. It is never deleted without confirmation from the user.

Synchronization takes just a few seconds and is usually automatically initiated upon connection.

If the following dialog box appears, click the appropriate selection.

Note ·

Only the Patient Folder currently shown in OTOflex 100 will be transferred to

OTOsuite during synchronization. Other Patient Folders made while OTOflex 100 was off-line must be transferred manually.

8.5.2

Synchronization of corrections made to Patient Folders

If you have made changes to for instance reflex thresholds or tympanometric classification values, either in OTOflex 100 or in the Immittance Module, these will be synchronized.

The most recent change, regardless of whether it was made in OTOflex 100 or in the

Immittance Module, will be applied or synchronised.

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103

Managing Test Results in OTOflex 100

Communicating and synchronizing with OTOsuite

104

Otometrics

9 Printing

You can print results from OTOsuite.

If you print via OTOflex 100, when connected to OTOsuite, printing will be done on the PC’s default printer.

Printing from OTOsuite is described in the OTOsuite User Manual.

Otometrics

105

Printing

106

Otometrics

10 Testing with the OTOsuite Immittance Module

10.1

Sequence testing

A test sequence is a predefined set of automatic tests which can be performed automatically.

The Immittance Module will always perform the most recently selected sequence, regardless of whether it has been selected in the Immittance Module or in

OTOflex 100.

10.1.1

Selecting a test sequence

• Select the appropriate test sequence:

– OTOflex 100:

Menu > Procedure Options.. > Sequence

– The Immittance Module: In the

Sequence

field below the

Navigation Panel

click the drop-down list to select.

10.1.2

T + RS (Tympanometry + Reflex Screening)

For procedures, see 10.3 Tympanometric testing  112 , and

10.2.2 Acoustic Reflex

Screening  110

.

Practical for basic hearing assessment.

The Tympanometry and Reflex results are available in two different views, where the

Tympanometry view shows a small Reflex table, and the Reflex view shows a small

Tympanometry graph.

From the Tympanometry view you can perform Reflex Screening. For a more elaborate view, select Reflex Threshold, either as an individual test, or in a sequence with

Tympanometry.

Initially, only reflex screening results are shown in both the Tympanometry view and

Reflex Threshold view. If a threshold measurement is made at the same frequency as the current screening result, then the threshold overwrites that specific screening result in the threshold view. This means that only Reflex Screening results are shown in the reflex view as long as no Reflex Threshold tests have been made.

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Testing with the OTOsuite Immittance Module

Sequence testing

10.1.3

T + RT (Tympanometry + Reflex Thresholds)

For procedures, see 10.3 Tympanometric testing  112 , and

10.4.1 Automatic and semiautomatic threshold testing  115

.

For full diagnostic hearing evaluation.

10.1.4

T + RT + RD (Tympanometry + Reflex Threshold + Reflex Decay)

For procedures, see 10.3 Tympanometric testing  112 , and

10.4.1 Automatic and semiautomatic threshold testing  115

, and 10.5.1 Automatic Acoustic Reflex

Decay testing  122

.

For full diagnostic hearing evaluation with suspicion of retrocochlear disorder.

Note ·

The Reflex Thresholds are included in the test sequence in order to measure Reflex

Decay, since the decay stimulus intensities are based on thresholds.

10.1.5

Running a test sequence from the Immittance Module

1. Connect to the test device.

2. Select the desired sequence from the drop-down list below the Immittance Module

Control Panel

.

3. Click

Start/pause

to start the entire sequence selected.

If

Tools > Options > General > Auto start on seal

is set to Sequence, the sequence starts as soon as probe seal is achieved.

If the patient is troubled by the test, click

Stop

to stop the test. The test is interrupted immediately.

If a leak is detected or the probe is removed from the patient's ear, the sequence is automatically paused (a sequence can also be paused manually). The sequence can then be stopped or it can be resumed after a seal has been reestablished.

4. Click

Pause

if you wish to manually pause the progress of the sequence.

When you resume reflex testing, the test continues at the intensity level during which the interruption occurred.

When

Pause

flashes, click again to resume testing.

5. Click

Skip

to skip the ongoing measurement and continue with the next.

6. Click

Stop sequence

to stop the entire sequence.

• If

Tools > Options > General > Auto resume on seal

is Off: 

The probe must remain in place throughout the sequence. If the probe is removed, the test will restart with Tympanometry testing when testing is resumed.

108

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Testing with the OTOsuite Immittance Module

Screening

• If

Tools > Options > General > Auto resume on seal

is On: 

If the probe is removed from the patient’s ear or if there is leakage, the sequence will automatically resume from the pause state when the seal is reestablished.

When a sequence is resumed, it will always continue from where it was paused.

An interrupted reflex stimulus will be repeated.

If the leak appears during the tympanometric measurement, the tymp part of the sequence will not be repeated. Press

stop

and restart the sequence if you need to repeat the tympanometric measurement.

10.2

Screening

Use screening eartips for screening. It is important that you hold the probe with a steady grip to prevent probe movements from resulting in leakage or changes in admittance.

Control Panel

1. Do as described in

6 Preparing OTOflex 100 and the Immittance Module for testing  49 .

2. Switch on OTOflex 100. If you want to perform the test from OTOflex 100, see the OTOflex 100 manual for instructions.

3. Open the Immittance Module with the

Tympanometry

test selected.

4. Click the

Control Panel

icon on the Immittance Module toolbar. The device settings are shown in the

Control Panel

.

5. If needed, press the

Ear Selector

key to toggle to the ear on which you wish to start the test.

6. Load a test setting configured for screening patients in the relevant age group.

7. If contralateral stimulation is used in the reflex test, make sure that both the Ipsi probe and the Contra insert phone are in place before you start the measurement.

8. Ask the patient to sit very still and quiet during the test, without moving head or jaw.

9. Continue with either

10.2.1 Screening tympanometry  109 or

10.2.2 Acoustic Reflex Screening  110 .

10.2.1

Screening tympanometry

The default test setting applying to the Tympanometry test screen is not designed specifically for screening tympanometry.

1. Click

Start

on the

Control Panel

without applying the eartip to the patient’s ear.

This prepares OTOflex 100 to start measuring as soon as seal is achieved.

2. Apply the probe to the patient’s ear with a steady grip.

3. The test starts automatically as soon as a good probe fit with an air-tight seal is achieved.

Otometrics

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Testing with the OTOsuite Immittance Module

Screening

Settings - Screening tympanometry

When you perform screening tympanometry, the following settings make this test even quicker:

Tools > Options > General > Auto start on seal

Sequence

The test starts automatically as soon as a good probe fit with an airtight seal is achieved. Regardless of the setting in

Tools > Options > Tymp. and Reflex Scr. >

Auto next curve

, the Immittance Module automatically changes to the next tymp curve for each tymp sweep. This is to prevent overwriting already recorded tymps, if a tymp measurement is triggered by accident.

Tools > Options > Tymp. and Reflex Scr. > Stop when results are available

On

Control Panel > Pump Speed

AFAP

Reflex Screening results

The Reflex results shown in the Reflex Threshold view are reflex screening results. If, subsequently a Reflex Threshold test (see

10.4.1 Automatic and semiautomatic threshold testing  115

) is made using the same stimulus types as in Reflex Screening, the results from this test will replace the screening values shown in this view.

10.2.2

Acoustic Reflex Screening

In the

Tympanometry

test screen, the Reflex Screening section shows reflex screening values if reflex screening measurements are available, or crossed out values if they are not.

If, subsequently, a Reflex Threshold test (see

10.4.1 Automatic and semiautomatic threshold testing  115

) is made using the same stimulus types as in Reflex Screening, the results from the RT test will replace the RS values shown in this view. Any stimulus types not tested during a Reflex Threshold test will remain in the Reflex

Screening results table.

Reflex Screening automatically follows the tympanometry sweep if you start the

T+RS sequence (see 10.1 Sequence testing  107 ).

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Testing with the OTOsuite Immittance Module

Screening

Otometrics

1. If needed, adjust the appropriate settings.

Important ·

In Screening mode the safety intensity level cannot be exceeded.

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL. See also

10.4 Acoustic Reflex Threshold testing

114

.

2. Click

Start

on the

Control Panel

without applying the eartip to the patient’s ear.

This prepares the device to start measuring as soon as seal is achieved.

3. Apply the probe to the patient’s ear with a steady grip.

4. The test starts automatically as soon as a good probe fit with an air-tight seal is achieved.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, click

Stop

. The test is interrupted immediately. Already measured results are kept.

5. If needed, click

Pause

on the

Control Panel

to interrupt the test. Click the flashing

Pause

button to resume. After the pause the Immittance Module resumes at the intensity it came to or was interrupted in.

Settings - Reflex screening

Tools > Options > Tymp. and Reflex Scr. > Stimulus Intensities > Increment

(dB)

Step in dB between each stimulus intensity presented. If e.g. the increment is set to 10 dB and the number of intensities is set to 2, the first presentation will be at the max intensity 

-10 dB.

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Testing with the OTOsuite Immittance Module

Tympanometric testing

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL.

Tools > Options > General > Auto start on seal

If set to Sequence, the test starts automatically as soon as a good probe fit with an airtight seal is achieved.

If not, press

Start

on the

Control Panel

to prepare OTOflex 100 to start measuring as soon as seal is achieved.

Tools > Options > General > Auto resume on seal

If you use screening eartips, it is recommended that this setting is On. The test is then activated or resumed as soon as there is seal, i.e. when the screening eartip is pressed against the ear.

If set to Off: The screening eartip must remain in place against the patient’s ear.

If the probe is removed, the test is interrupted.

• Tools > Options > Tymp. and Reflex Scr. > Auto Reflex Screening > Reflex

Criterion

Sequence settings - Reflex screening

If you are performing a Tympanometry + Reflex Screening autosequence using screening eartips, set

Tools > Options > General > Auto start on seal

to Sequence.

The test will start with Tympanometry testing and continue automatically from

Tympanometry to Reflex Screening.

10.3

Tympanometric testing

Note ·

You should always conduct a tympanometric test before making any acoustic reflex measurements. Also, you should always determine the acoustic reflex threshold before making a reflex decay measurement.

10.3.1

Diagnostic tympanometry

The default setup available in the tympanometry test is designed for any of the tympanometry tests you can perform. Adjust the settings to suit your purposes.

112

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The test

Testing with the OTOsuite Immittance Module

Tympanometric testing

Otometrics

1. Check and adjust the appropriate settings.

2. Fit the patient with the probe.

3. Click

Start

on the

Control Panel

to start the Tympanometric measurementS.

Warning ·

If the patient is troubled by the test, click

Stop

. The pump pressure is relieved immediately.

The curve that has been recorded up to that point remains as a measurement.

4. If there is leakage, this is shown on the screen. See

10.8 Leakage  127 .

5. The test progresses as follows:

– The pump increases the pressure to the maximum value set in

Tools >

Options > Tymp. and Reflex Scr. > Pressure axis - Range

and depending on

Control Panel > Sweep direction

.

– As soon as the predefined pressure has been reached, the sweep starts.

– As the sweep progresses, the admittance for each pressure point is plotted out on the screen and forms the tympanogram curve. During the measurement, two diamond markers signify the following:

- an admittance marker just to the right of the admittance axis, indicating the current admittance, and

- a pressure marker on the pressure axis, indicating the current pressure.

– Tympanometric test results are shown in a results view in the top right corner of the window.

6. To make a new sweep, click

Start

on the

Control Panel

.

You can save up to 3 separate measurements for each ear in a Patient Folder.

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

Settings - Diagnostic tympanometry

Tools > Options > Tymp. and Reflex Scr. > Auto next curve

10.3.2

ETF-I, Eustachian Tube Function - Intact

Note ·

This test is available only if OTOflex 100 supports diagnostic testing.

The test

1. Record a tympanogram. See

10.3.1 Diagnostic tympanometry  112

for instructions.

2. Instruct the patient to perform either Valsalva’s or Toynbee’s maneuver (see the

OTOflex 100 Guides).

3. Record a second tympanogram.

4. Compare the tympanograms from step 1 and 3 in a multilayered tympanogram

(set

Tools > Options > Tymp. and Reflex Scr. > Layered curves

to Yes).

5. It may be useful to repeat the procedure using different techniques and maneuvers in a sequence of testing to fully evaluate the functioning of the Eustachian tube.

Settings - ETF-I

• Tools > Options > Tymp. and Reflex Scr. > Auto next curve

10.4

Acoustic Reflex Threshold testing

This test type is available only if OTOflex 100 supports diagnostic testing.

10.4.1 Automatic and semiautomatic threshold testing  115

10.4.2 Manual threshold testing  119

Note ·

You should always conduct a tympanometric test before making any acoustic reflex measurement. Also, you should always establish the acoustic reflex threshold before making a reflex decay measurement.

Automatic and semi-automatic testing

The automatic or semi-automatic tests provided by OTOsuite provide the easiest way to measure acoustic reflexes. Manual editing and testing is also available for specific stimulus intensities.

When you test reflexes using these automatic or semi-automatic features, the reflexes are automatically determined using different stimulus levels. These levels are predefined, but can be adjusted by the user. This means that in some cases, it may be necessary to customise the settings relating to automatic testing. These settings are found in the

Automatic

section in the

Tools > Options > Reflex Threshold/Reflex

Decay > Stimulus types

dialogs.

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

When you use automatic or semi-automatic testing or when you use test sequences, always make sure that these automatic settings are appropriate!

High stimulus intensities

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL. When testing the stimulus types between

500 and 2000 Hz, reflexes not found at this intensity are considered abnormally elevated (using a 2-standard deviation criterion from the average threshold level in adults).

Whenever a stimulus level exceeds the warning level (> 108 dB SPL re 2 cc corresponding to >=115 dB SPL in 0.5 cc), the stimulus intensity value will start flashing and automatic testing is paused. You are then prompted to decide whether to continue or skip to the next stimulus type.

Warning ·

When you test on small ears, the sound pressure level will increase in the ear canal. It is therefore not recommended to exceed the warning level when testing on patients with small ear canals.

10.4.1

Automatic and semiautomatic threshold testing

Before reflex testing:

• Warn the patient about the high stimulus levels, which are used to elicit the reflex. If the high sound levels are unaccept-able to the patient, you may have to abort testing.

• Ask the patient to sit very still and quiet during this test, without moving head or jaw.

• If contralateral stimulation is included, make sure that both Ipsi probe and Contra insert phones are in place before you start the measurement. See the

OTOflex 100 Guides.

Automatic and semi-automatic Threshold testing

1. Press

PageDown

to go to the Reflex Threshold test screen, or select the test from

View > Immittance >

.

The Reflex results shown in the Reflex Threshold view are reflex screening results. If you subsequently make a Reflex Threshold test using the same stimu-

lus type (see 10.4.1 Automatic and semiautomatic threshold testing  115

), the results from this test will replace the ones shown in this view.

Reflex Threshold automatically follows the tympanometry sweep if you start the

T+RT sequence (see

10.1 Sequence testing  107 ).

Otometrics

115

Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

116

The bold horizontal line in each graph indicates the predefined reflex criterion. It is offset from the base line marker on the vertical axis. The degree of offset is influenced by the setting in

Tools > Options > Reflex Threshold > General - Reflex criterion

(mmho)

.

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus levels when reaching the warning limits, it is recommended that you set the max.

intensity to 95 dB HL. See also 10.4 Acoustic Reflex Threshold testing

114

.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, press

Stop

. The test is interrupted immediately. Already measured results can be saved.

To start automatic testing:

Click

Start

in the

Auto

section of the

Control Panel

to start a fully automatic reflex threshold search for all preset stimuli.

To start semi-automatic testing:

Click

Start

in the

Manual

section of the

Control Panel

to start a semi-auto-

matic reflex threshold search for the stimulus type selected on the

Control

Panel

. The settings in

Tools > Options > Reflex Threshold > Stimulus

Types >

control the threshold search.

To pause the test, if needed, click

Pause

on the

Control Panel

.

To resume testing, click the flashing

Pause

. After the pause the test continues at the intensity level during which the interruption occurred.

2. If

Tools > Options > General > Auto resume on seal

is On, testing resumes when probe fit is good.

Otometrics

Otometrics

Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

– Threshold not found immediately:

The stimulus intensities will increase until a reflex threshold is registered or until the max. intensity is reached.

– Threshold found immediately:

The test will automatically decrease the stimulus intensities until a threshold is no longer registered.

3. Depending on your settings in

Tools > Options > Reflex Threshold > Verification

, you can select the type of verification strategy to be used after the deflection criterion has been met by the automatic threshold search.

The lowest stimulus intensity where the reflex criterion was met may be retested for reproducibility, or the next one or two intensity levels can be used to confirm the reflex growth properties.

4. As the test progresses, various fields are updated continuously on the screen:

Deflection curves

The deflection curves are shown on the screen, eventually resulting in a complete Reflex deflection graph. The curves shown are always sorted according to increased stimulus intensity.

Tympanogram

In the top right corner of the screen, the most recent tympanogram, if available for the currently used probe tone, is displayed, and a marker on the pressure axis indicates the current ear canal pressure. The curve number is also indicated.

Audiogram

The applicable acoustic reflex threshold symbols appear in the audiogram in the bottom right corner of the screen. The Not found symbol is used until the threshold level has been reached.

The following symbols are used in the audiogram:

Pure tone air unmasked/masked (L)

Pure tone bone unmasked/masked (L)

Ipsi Thr. found/not found (L)

Contra Thr. found/not found (Stim:R)

Important ·

Although the audiogram symbols for the contralateral reflex measurement refer to the stimulus ear (i.e. symbol and colour for the non-probe ear), the symbols are shown in the probe-ear audiogram.

Thresholds table

The determined threshold is shown in the Thresholds table in the bottom part of the screen. The Ipsi results appear in the top row. The stimulus ear referenced contralateral results appear in the bottom row.

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

118

The measurement stops automatically when satisfactory values have been registered.

Deflection curves

The graph representing the automatically determined threshold at the top of the screen is shown in a frame.

Thresholds table

The determined threshold is shown in the Thresholds table in the bottom part of the screen. If no threshold is detected, the field in the Thresholds table will show the text “None” to indicate the absent threshold.

Audiogram

The audiogram marker in the audiogram in the bottom right part of the screen indicates the threshold level or the highest intensity where threshold was not found.

If a measurement consists of more than 3 intensities, click the graph selector to scroll between the graphs.

5. If you want to manually change the automatically determined threshold: click on the drop-down box of the specific field in the Thresholds table and select the stimulus intensity to be reported as the threshold value. The manually selected value will be marked by an asterisk, the appropriate graph at the top of the screen is framed accordingly, and the audiogram marker in the audiogram in the bottom right part of the screen is updated.

6. If you want to continue with manual testing, go to

10.4.2 Manual threshold testing  119 .

Otometrics

Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

Settings - Automatic and semi-automatic Reflex Threshold

Tools > Options > General > Auto resume on seal

Off:

If there is a probe leak, the test is interrupted. You must resume testing manually if testing is paused due to a leak.

On: 

Testing resumes automatically when a proper seal is obtained if testing was paused due to a leak.

Control Panel > Custom TPP offset

Checked:

The pressure is offset from the TPP by the TPP offset defined in

Tools >

Options > Reflex Threshold > General > Custom TPP offset

. If the offset is is set to a value with the post fix “more”, it shifts the pressure in the same direction as the sign of the TPP, and in the opposite direction if it is set to “less”.

Note ·

The TPP value from the most recent tympanometric curve at the same probe tone is used in reflex measurements.

Note ·

When the

Control Panel > Custom TPP offset

setting is changed in Acoustic

Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting to ensure consistent reflex testing, but not vice-versa.

Tools > Options > Reflex Threshold > Verification

Depending on your settings, you can select the type of verification to be used:

The lowest stimulus intensity, where the reflex criterion was met, may be retested for reproduceability, or the next one or two intensity levels can be used to confirm the reflex growth properties.

10.4.2

Manual threshold testing

If a threshold is not found during automatic or semi-automatic testing, you can test specific stimulus intensities manually:

1. Press

PageDown

to go to the Reflex Threshold test screen, or select the test from

View > Immittance

.

Otometrics

The bold horizontal line in each graph indicates the predefined reflex criterion. It is shown in relation to the base line marker on the vertical axis. The distance between

119

Testing with the OTOsuite Immittance Module

Acoustic Reflex Threshold testing

the two is influenced by the setting in

Tools > Options > Reflex Threshold > General > Reflex criterion (mmho)

.

2. Check and adjust the appropriate Control Panel and Test settings.

– Select the appropriate

Stimulus

,

Intensity

and

Stimulus Side

in the

Control

Panel

.

Control Panel > Custom TPP offset

If checked in Acoustic Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting, but not vice-versa.

– If needed, adjust the view setting

Deflection axis - Scale

.

– If you select a

Control Panel > Stimulus

setting not included in your view setting setup, the Thresholds table is automatically updated to show the selection when the test is started.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, click

Stop

on the screen to stop the test. The test is interrupted immediately. Already measured results can be saved.

3. Click

Start stimulus

in the

Manual

section of the

Control Panel

to present a single stimulus intensity.

4. If there is leakage, an icon visualises the problem on the screen.

5. As the test progresses various fields are updated continuously on the screen. See

10.4.1 Automatic and semiautomatic threshold testing  115 .

6. Depending on your method of approach, repeat using the appropriate stimulus levels until the test is satisfactory.

7. To manually determine a threshold, click on the drop-down box of the specific field in the Thresholds table and select the stimulus intensity to be reported as the threshold value.

Deflection curves

The graph representing the manually determined threshold in the Thresholds table is framed accordingly.

Thresholds table

Until a threshold value in the Thresholds table in the bottom part of the screen has been manually determined, a highlighted box will show the text

“None” to indicate that no threshold has been determined. When determined, the manually selected value will be marked by an asterisk.

Audiogram

The audiogram marker in the audiogram at the bottom right of the screen indicates the threshold level or the highest intensity where threshold was not found.

When a threshold is manually determined, the audiogram marker is updated.

Important ·

The audiogram symbol for “Not found” will remain until a threshold is determined manually.

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Decay testing

If a measurement consists of more than 3 intensities, click the graph selector to scroll between the graphs.

Measurements saved

You can save separate test measurements for a particular stimulus type (e.g. different frequencies or noise) for each ear. You can always highlight a graph, which will then be overwritten when you make a new measurement.

The three curves (showing reflex responses) with the highest intensity where the threshold value has been detected are stored automatically by the system.

If you repeat a measurement at a specific intensity, the previous value will be overwritten. As a consequence, you cannot see several curves with the same intensity.

If a measurement consists of more than 3 intensities, toggle the graph selector to view the graphs.

10.5

Acoustic Reflex Decay testing

Note ·

If you are using an OTOflex 100 Quick Check test device, you cannot control

Acoustic Reflex Decay testing from the OTOsuite Immittance Module.

The decay test stimulus level pre-supposes that there is a reflex threshold available for the ear, stimulus type and stimulus ear (ipsi- or contralateral) that is chosen for reflex decay testing. The decay test stimulus level will then automatically be set to the threshold level +10 dB.

If no reflex threshold is available, the

Control Panel > Intensity

setting is Off. This is useful for admittance monitoring.

For a maximum amount of monitoring time, set the

Tools > Options > Reflex Decay

> Stimulus Timing > Stimulus

setting to 26 seconds and

Control Panel > Intensity

to Off. The resulting curve can be saved as an ordinary decay graph.

Note ·

There may be a warning that the stimulus level is in the extended intensity range.

Reflex decay may not be possible due to highly elevated threshold levels.

Max. intensity levels

Ipsi

Contra

500 Hz 1000 Hz

50 to 105 dB HL ± 3 dB 50 to 120 dB HL ± 3 dB

50 to 115 dB HL ± 3 dB 50 to 120 dB HL ± 3 dB

Otometrics

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Decay testing

10.5.1

Automatic Acoustic Reflex Decay testing

1. Press

PageDown

to go to the Reflex Decay test screen, or select the test from

View > Immittance

.

122

Note ·

The decay test stimulus intensity pre-supposes that there is a reflex threshold available for the ear, stimulus type and stimulus ear (ipsi- or contralateral) that is chosen for reflex decay testing. The decay test stimulus intensity will then automatically be set to the threshold level +10 dB.

Note ·

There may be a warning that the stimulus level is in the extended intensity range.

Reflex decay may not be possible due to highly elevated threshold levels.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, click

Stop

on the screen. The test is interrupted immediately. Already measured results can be saved.

2. Click

Start

in the

Auto

section of the

Control Panel

to start a fully automatic reflex decay test for the preset stimuli.

– To interrupt the test, if needed, click

Pause

on the

Control Panel

.

– To resume testing, click the flashing

Pause

. After the pause the test continues at the intensity level during which the interruption occurred.

3. If

Tools > Options > General > Auto resume on seal

is On, testing resumes when probe fit is good.

Otometrics

Testing with the OTOsuite Immittance Module

Acoustic Reflex Decay testing

Measurements saved

Since a reflex decay measurement typically is made using either ipsilateral or contralateral stimulus side (not both), only two measurements are saved, i.e. different stimuli and/or ipsi/contra.

To view the graphs, click the appropriate field in the Half-life time table at the bottom of the screen.

Settings - Automatic Reflex Decay

Tools > Options > General > Auto resume on seal

Off:

If there is a probe leak, the test is interrupted. You must resume testing manually if testing is paused due to a leak.

On: 

Testing resumes automatically when a proper seal is obtained if testing was paused due to a leak.

Control Panel > Custom TPP offset

Checked:

The pressure is offset from the TPP by the TPP offset defined in

Tools >

Options > Reflex Decay > General > Custom TPP offset

. If the offset is is set to a value with the post fix “more”, it shifts the pressure in the same direction as the sign of the TPP, and in the opposite directionif it is set to “less”.

Note ·

The TPP value from the most recent tympanometric curve at the same probe tone is used in reflex measurements.

Note ·

When the

Control Panel > Custom TPP offset

setting is changed in Acoustic

Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting to ensure consistent reflex testing, but not vice-versa.

10.5.2

Manual Acoustic Reflex Decay testing

Note ·

The manual reflex decay test available in the OTOflex 100 Quick Check version cannot be remotely controlled from the OTOsuite Immittance Module.

1. Press

PageDown

to go to the Reflex Decay test screen, or select the test from

View > Immittance

.

Otometrics

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Testing with the OTOsuite Immittance Module

Acoustic Reflex Decay testing

124

– Select the appropriate

Stimulus

,

Intensity

and

Stimulus Side

in the

Control

Panel

.

Control Panel > Custom TPP offset

If checked in Acoustic Reflex Threshold, this setting is automatically applied in the Acoustic Reflex Decay test setting, but not vice-versa.

– If needed, adjust the view setting

Deflection scale

.

– If you select a

Control Panel > Stimulus

setting not included in your view setting setup, the Thresholds table is automatically updated to show the selection when the test is started.

Note ·

The decay test stimulus intensity pre-supposes that there is a reflex threshold available for the ear, stimulus type and stimulus ear (ipsi- or contralateral) that is chosen for reflex decay testing. The decay test stimulus intensity will then automatically be set to the threshold level +10 dB.

Note ·

There may be a warning that the stimulus level is in the extended intensity range.

Reflex decay may not be possible due to highly elevated threshold levels.

Warning ·

If the patient is troubled by the high stimulus levels in the ear currently being tested, click

Stop

on the screen. The test is interrupted immediately. Already measured results can be saved.

2. Click

Start stimulus

in the

Manual

section of the

Control Panel

to do a single reflex decay test.

– To interrupt the test, if needed, click

Pause

on the

Control Panel

.

Otometrics

Testing with the OTOsuite Immittance Module

ETF-P (Eustachian Tube Function - Perforated)

– To resume testing, click the flashing

Pause

. After the pause the test continues at the intensity level during which the interruption occurred.

Measurements saved

Since a reflex decay measurement typically is made using either ipsilateral or contralateral stimulus side (not both), only two measurements are saved, i.e. different stimuli and/or ipsi/contra.

To view the graphs, click the appropriate field in the Half-life time table at the bottom of the screen.

10.6

ETF-P (Eustachian Tube Function - Perforated)

1. Record a tympanogram to confirm the perforation. The resulting tympanogram curve will be flat, and the ear canal volume will be abnormally high because it

includes the volume of the entire middle ear. If needed, see 10.3.1 Diagnostic tympanometry  112

for instructions.

2. Press

PageDown

to go to the ETF-P test screen, or select the test from

View >

Immittance

.

3. The

ETF-P

screen appears.

Otometrics

Note ·

The pressure range available for positive and negative pressures (including

400 daPa and -600 daPa) is commonly used in ETF-P testing. See

Control Panel >

Positive/Negative pressure

.

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Testing with the OTOsuite Immittance Module

Managing test results

4. The end time is always max. 60 seconds, but to facilitate viewing, you can set a lower initial time value in

Tools > Options > ETF-P > Time axis > Scale (sec.)

, which will then be shown on the horizontal axis.

If the initial time scale value is exceeded during the measurement, the axis automatically expands by 10 second steps to a maximum of 60 seconds.

5. Click the

Pressure control

button on the

Control Panel

to start testing.

– If

Control Panel > Initial pressure

is set to Positive, the

Pressure control

button points upwards.

– If

Control Panel > Initial pressure

is set to Negative, the

Pressure control

button points downwards.

Press to automatically build up pressure until the first opening of the Eustachian tube or max. pressure is reached. The pressure control is automatically reversed after one of the two criteria has been reached.

6. To view the graphs, click the appropriate field in the Half-life time table at the bottom of the screen.

7. One curve per ear is saved.

10.7

Managing test results

10.7.1

Tests and subtests

Test

Covers all test results from e.g. a reflex threshold examination, or all tymp curves (one ear only).

Sub-test

Covers the currently selected part of a test, e.g. all tested intensities for a specific stimulus for a reflex test, or a single tymp curve.

10.7.2

Swapping ear data

If you have tested a patient with the wrong ear selected in OTOsuite, you can swap the ear data so that it is assigned to the other ear.

Note ·

You cannot swap ear data that has already been saved or printed.

You can swap ear data during a session or after a session. Swapping applies to all data in the selected Patient Folder.

• To do so, select

Edit > Swap Ear Results..

If you select

Yes

, the data will be assigned to the other ear.

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Leakage

10.7.3

Deleting data

Deleting results

When you select

Edit > Delete Selected Sub-Test

you delete:

• Any single tympanometric curve (identified by curve number)

• Any full set of curves relating to a specific reflex stimulus type for one of the reflex tests (e.g. all Reflex decay curves for Ipsi 2000 Hz stimuli)

• The ETF-P curve

Deleting sub-tests

To delete a sub-test:

1. Click on one of the curve or graph icons in this icon group to view a specific curve or graph. The curve will then be highlighted.

2. To delete a curve, select

Edit > Delete Selected Test

.

10.8

Leakage

Testing may be complicated by a number of factors which can result in leakage or probe problems. Leakage can, for instance, be caused by:

• badly fitting eartips,

• eartip not inserted properly in the ear canal,

• ear canal debris blocking for proper ear tip seal,

• old, hardened eartip,

• pneumatic probe plug not inserted properly in OTOflex 100,

• probe tip not tightened properly.

Probe problems may be caused by:

• an occluded probe,

• a blocked wax filter.

Leakage and probe occlusion is shown on the screen during testing.

Leak detection

If there is leakage or if the probe is blocked during testing, the window in the top right corner of the screen visualises the problem.

• Probe seal obtained

• Probe blocked

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Testing with the OTOsuite Immittance Module

Testing the other ear

• Probe leak

• Probe not inserted

Adjust the position of the probe, or clean the probe, and continue testing.

10.9

Testing the other ear

When you have finished testing one ear, select the other ear, if needed:

1. Toggle the Ear selection icon on the OTOsuite toolbar before testing the other ear.

The icon shows the currently active probe ear.

2. Switch the probe (and, if needed, insert phone) to the opposite ear(s).

3. Continue testing.

10.10

Saving measurements

The Immittance Module keeps 3 curves for each ear. When you have made the number of measurements you require, you can save the curves.

1. To save the patient folder, select

File > Save

, or click the

Save measurements

icon on the OTOsuite toolbar.

You can save 3 separate tympanometric measurement results for each ear. If you wish to delete any of the curves, see Deleting results  127 .

Note ·

Contralateral measurements saved apply to the stimulus ear.

10.10.1 Standards used in NOAH

When measurements relating to the stimulus ear are saved in NOAH, they are denoted by specific abbreviations, for instance: “T+IT+ID+ETFP”.

The following abbreviations are used for the various test types, when test results are saved in NOAH:

Tympanometry

T

T

ympanometric measurements

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Testing with the OTOsuite Immittance Module

Preparing for the next patient

Reflex Screening

RS

IS

CS

If an action contains both ipsilateral and contralateral

R

eflex

S

creening measurements.

If an action contains only

I

psilateral

S

creening measurements

If an action contains only

C

ontralateral

S

creening measurements

Reflex Threshold

RT

IT

CT

If an action contains both ipsilateral and contralateral

R

eflex

T

hreshold measurements.

If an action contains only

I

psilateral

T

hreshold measurements

If an action contains only

C

ontralateral

T

hreshold measurements

Reflex Decay

RD

IS

CS

If an action contains both ipsilateral and contralateral

R

eflex

D

ecay measurements.

If an action contains only

I

psilateral

D

ecay measurements

If an action contains only

C

ontralateral

D

ecay measurements

ETF-P

ETFP

ETF-P (Eustachian Tube Function - Perforated)

10.11

Preparing for the next patient

When you have finished testing a patient and wish to test a new patient:

1. For the sake of patient privacy, when you receive a new patient, make sure that computer screen and test device do not show any information about previous patient.

2. Select or create a new patient. If you have not already saved the test results, you will be prompted to do so. Click

Save

or

Cancel

as needed.

3. Prepare for the next patient, as described in 6 Preparing OTOflex 100 and the

Immittance Module for testing  49

.

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Testing with the OTOsuite Immittance Module

Preparing for the next patient

130

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11 Data management in MADSEN OTOflex 100

11.1

Data handling

Handling of data shared by OTOflex 100 and OTOsuite is to a large degree automated.

As a general rule:

• Communication between OTOsuite and OTOflex 100 is defined by

OTOflex 100. This means that the patient folder currently shown on

OTOflex 100 will be transferred automatically to OTOsuite.

• Measurements settings are always synchronised, allowing OTOflex 100 to continue unaffected if the connection to the PC should be lost.

11.1.1

Interruption of communication

Communication via Bluetooth is in OTOflex 100 set to On as default.

If the Bluetooth connection between OTOflex 100 and OTOsuite is interrupted, communication with OTOflex 100 is disconnected.

• If reconnecting while the current patient folder is the same in OTOflex 100 and

OTOsuite, synchronisation is done automatically.

• If reconnecting after the current patient folder is changed on either

OTOflex 100 or in OTOsuite, you will be prompted to synchronise data or cancel.

11.1.2

Synchronization

Data is usually transferred from OTOflex 100 to OTOsuite and the data is never deleted without confirmation from the user.

Synchronization takes just a few seconds and is in many cases automatically initiated on connection.

• If you synchronize, the patient folder shown in OTOflex 100 will be overwritten.

• If you cancel synchronization, you can save/print out the patient folder shown in

OTOflex 100, and then synchronize.

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Data management in MADSEN OTOflex 100

Uploading test results to OTOsuite

Note ·

Only the patient folder currently shown in the test device will be transferred to

OTOsuite during synchronization. Other patient folders made while OTOflex 100 was

off-line must be transferred manually. To do so, see 11.2 Uploading test results to

OTOsuite

132

.

Synchronization of corrections made to measurements

If you have made changes to for instance reflex threshold or tympanometric classification values, either in OTOsuite or in OTOflex 100, these changes are given a time stamp.

The most recent change, regardless of whether it was made in OTOsuite or in

OTOflex 100, will be applied or synchronised.

Synchronizing patient folders

If patient folders on the PC and in the test device are not synchronized when OTOsuite connects to OTOflex 100, they will be synchronized automatically or you will be prompted to resolve synchronization conflicts, depending on the settings in the

Configuration Wizard.

In OTOsuite select

Tools > Configuration Wizard > Configure Immittance

. Select

the setting of your choice. See 16 Configuring OTOsuite  213 .

11.2

Uploading test results to OTOsuite

Use OTOsuite to get test results from OTOflex 100.

When you use OTOsuite, you can transfer patient folders from the OTOflex 100.

To do so,

In the Immittance Module:

• Click the

Get Test Results

icon or

• Select

Measurement > Get Test Results from Device

.

If Bluetooth communication is enabled in OTOflex 100, OTOsuite automatically connects to OTOflex 100 to get data and then disconnects. If online, it uses the already established connection.

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Data management in MADSEN OTOflex 100

Data clean-up

11.3

.

• Select from the dialog box shown.

4. Click on the set of data you wish to upload and click

OK

.

If data is already available in OTOsuite, you are prompted to either overwrite the data or cancel.

OTOsuite automatically disconnects from OTOflex 100 when data has been transferred.

Data clean-up

If the memory of OTOflex 100 is running full, or you want it to have as much memory available as possible, you can clean up the data in OTOflex 100:

• In OTOflex 100 select

Menu > Manage Test Results

. This menu gives access to a number of functions for deleting specific or all test data.

Patient folders that have been saved in OTOsuite or printed will be deleted by

OTOflex 100 when the memory is running full.

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Data management in MADSEN OTOflex 100

Data clean-up

134

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12 Immittance test setup in MADSEN OTOflex 100

12.1

Test settings

A test setup consists of settings, including procedure options such as currently selected test sequence, auto start on seal, etc., which apply to the entire range of tests available in OTOflex 100. You can make changes to specific settings and save these changes as a test setup of your choice.

You can either use these settings, change the settings, or load a test setup, which you have defined.

Note ·

When OTOflex 100 connects to OTOsuite, the measurement settings in

OTOflex 100 are automatically transferred to the Immittance Module.

If you make changes in the measurement setup of both OTOflex 100 and OTOsuite,

OTOflex 100 will use the most recent settings.

When OTOflex 100 is connected to OTOsuite, you can make changes in the measurement setup in the Immittance Module and/or on OTOflex 100 as you like. The setup is synchronised and OTOflex 100 will always use the latest changes.

12.1.1

Changing individual settings

When you are going to make a test, and you have selected the test type, you can access a number of settings:

• Press

Select

to access the

Menu

.

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135

Immittance test setup in MADSEN OTOflex 100

Test settings

Actions

Settings specific to the selected test type

General settings

Start Sequence

Test Selector

Printers..

Patient & User..

My Settings..

Done!

Probe check

-----------------------------

Probe tone

..

..

More Settings..

-----------------------------

Manage Test Results..

Procedure Options..

Advanced..

Frequently used settings

Less used settings

..

..

..

Auto Settings..

Dissociate from

Users..

Device Settings..

Service..

Load Patient..

Swap Ear Results

Del. Sub-test..

Del. Current Test..

Del. Patient..

Del. All Printed Patients

Del. All Patients

Sequence

Auto start on seal

Auto resume on seal

Auto free memory

First ear to test

226 Hz tymp unit

226 Hz defl. unit

Intensity safety

‘Done’ prompt

Print when done

‘Patient’ prompt

‘Settings’ prompt

Frequently used settings

When you press

Menu

, the most frequently used test-specific settings you can view/change are shown.

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Immittance test setup in MADSEN OTOflex 100

Test settings

Scroll to view other menu items.

Less frequently used settings

Less used settings you can view/change by selecting

Menu > More Settings..

Settings for automatic testing

The settings listed in

Menu > More Settings.. > Auto Settings..

apply to automatic testing.

Settings for sequence testing and automatic functions

The settings listed in

Menu > Procedure Options

are settings relating to automatic testing, for instance when the test is part of a sequence of tests or when the individual test is done automatically

You can change and save these settings as specific measurement setups with a specific name, or you can download a setup of your choice from the Immittance Module.

When you activate OTOflex 100, the settings used in OTOflex 100 are automatically shown in the Control Panel and the Measurement Settings dialog box in the

Immittance Module.

To change the settings directly in OTOflex 100, select the appropriate test screen:

1. Press

Select

, scroll to the appropriate setting and press

Select

again.

If the setting is not available directly in the

Menu

, select

More settings..

, and if required,

Procedure Options..

, and scroll to the appropriate setting.

The settings may appear in abbreviated form, but when you scroll to the setting, the actual wording is shown.

2. Settings can be changed in two ways:

– If there is a list of values to choose from, press

Select

to access the values, scroll to view the required value, and press

Select

again to apply the shown value.

– If there are only two values to choose from, press

Select

to toggle to the required value.

3. The new setting is now shown in a highlighted box.

Note ·

The value in focus is selected even if you leave the menu without pressing

Select

.

Note ·

If there are unsaved changes in a test setup, this is indicated on the display by an asterisk next to the setup name.

12.1.2

Uploading test settings to the Immittance Module

When you connect to OTOsuite, the settings used in OTOflex 100 are automatically shown in the Control Panel and the Test Settings dialog of the Immittance Module.

Otometrics

137

Immittance test setup in MADSEN OTOflex 100

Test settings

12.1.3

Creating a setup

OTOflex 100 comes with the following default setups:

• The standard adult setups: IS, Pedi, TI, TIC, and TICD.

• The standard infant setup: Infant.

You can save these setups under a name of your choice, and then change to meet your requirements.

To create a specific Test Setup, do the following:

1. Load the most appropriate setup: Select

Menu > My Settings.. > Load Settings..

2. Select

Menu > My Settings.. > Save settings as..

3. You will first be prompted for a name: Edit or press

Select

.

4. The

File to replace

screen appears: Scroll to a field named <Empty> and press

Select

, or, if you want to overwrite an existing setup, scroll to the required setup and press

Select

.

5. Make the required changes to the various settings.

6. If you are not in the

Menu

, press

Select

to access the

Menu

.

12.1.4

Editing a test setup

If you want to make additional changes to a test setup, do the following:

1. Select

Menu > My Settings.. > Load settings..

2. Select the test setup of your choice and press

Select

.

3. Change the required settings.

4. Select

Menu > My Settings.. > Save settings

5. The test setup is overwritten.

12.1.5

Using a test setup

If you want to use another test setup than the one currently selected, do one of the following:

1. Select

Menu > My Settings.. > Load settings..

If

Menu > Procedure Options > ‘Settings’ prompt

is set to On, you will auto-

matically be prompted to load a test setup. See also 6.3.5 Test flow setup  59 .

2. Scroll to select the test setup of your choice and press

Select

.

or

• See the OTOsuite documentation for instructions on how to load settings in the Immittance Module.

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Immittance test setup in MADSEN OTOflex 100

General actions

12.2

General actions

These settings apply regardless of the test type or sequence selected. To access these settings:

• Select

Menu

.

General actions

Start Sequence

Test Selector

Printers..

Patient & User..

My Settings..

Start Sequence

Test Selector

Starts the selected sequence (set in

Menu > Procedure

Options > Sequence

). Alternatively, to activate the

Start

Sequence

function from the keypad, press and hold the

right softkey

.

If you activate this item 5 times instead of using the shortcut, you will see the hint: “Press and hold right softkey to start sequence”.

Activates the

Test Selector

. Alternatively, to activate the

Test Selector

from the keypad, press and hold

Select

.

New patient folder

If you activate this item 5 times instead of using the shortcut, you will see the hint: “Press and hold select key to select tests”.

Use this function for instance before you start testing a new patient.

Patient & User

My Settings..

OTOflex 100 automatically creates a new patient folder when switched on, of if

Menu > Procedure Options >

‘Patient’ prompt

is set to On.

Use this function to enter information about a patient and the user, for instance before you start testing a new patient.

Use this function to load or save predefined setups.

12.2.1

Manage test results

• Select

Menu > Manage Test Results

.

Otometrics

139

Immittance test setup in MADSEN OTOflex 100

General actions

Start Sequence

Test Selector

Printers..

Patient & User..

My Settings..

Done!

Probe check

-----------------------------

Probe tone

..

..

More Settings..

-----------------------------

Manage Test Results..

Procedure Options..

Advanced..

Load Patient..

Swap Ear Results

Del. Sub-test..

Del. Current Test..

Del. Patient..

Del. All Printed Patients

Del. All Patients

Load Patient

Select this function to load a patient folder of your choice.

The patient folders are identified by date and time, patient name, date of birth, gender and user.

Swap ear results

Del(ete) Sub-test

Del(ete) Current

Test

Del(ete) Patient

Del(ete) all printed patients

Icons show whether the individual patient folders have been saved or printed .

This function assigns test data to the other ear, for instance if you have forgotten to press the Ear Selector to define the ear currently being tested.

Select this function to delete individual measurements.

Select this function to delete all measurements in the current test.

Select this function to delete an entire Patient folder.

Select this function to delete all patients that have been printed.

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Immittance test setup in MADSEN OTOflex 100

General actions

Del(ete) all patients

Select this function to delete all patients in the

OTOflex 100 memory.

Note ·

Patient folders that have been saved or printed will be deleted automatically when the OTOflex 100 memory is full.

12.2.2

Procedure options

These settings apply regardless of the test type or sequence selected. To access these settings:

1. Press

Select

to access the

Menu

.

2. Scroll to

Procedure Options

and press

Select

.

Start Sequence

Test Selector

Printers..

Patient & User..

My Settings..

Done!

Probe check

-----------------------------

Probe tone

..

..

More Settings..

-----------------------------

Manage Test Results..

Procedure Options..

Advanced..

Sequence

Auto start on seal

Auto resume on seal

Auto free memory

First ear to test

226 Hz tymp unit

226 Hz defl. unit

Intensity safety

‘Done’ prompt

Print when done

‘Patient’ prompt

‘Settings’ prompt

Otometrics

141

Immittance test setup in MADSEN OTOflex 100

General actions

Sequence

Select the sequence to suit your purposes. You can choose between:

Auto start on seal

• T + RS

Tympanometry and Reflex Screening

• T + RT

Tympanometry and Reflex Threshold

• T + RT + RD

Tympanometry and Reflex Threshold and Reflex

Decay

To activate this function either select

Menu > Start

Sequence

, or press and hold the right softkey in test mode.

The system automatically starts the tympanometric measurement or the selected sequence as soon as the probe is properly fitted in the ear canal. Regardless of the setting in

Menu > More Settings.. > Auto next curve

, OTOflex 100 automatically changes to the next tymp curve for each tymp sweep. This is to prevent overwriting already recorded tymps, if a tymp measurement is triggered by accident.

Auto resume on seal

Default: Tymp

If a measurement is paused by a leak, the test or sequence is automatically resumed when the probe is properly refitted in the ear canal.

Default: On

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Otometrics

Immittance test setup in MADSEN OTOflex 100

General actions

Auto free memory

Setting for defining automatic deletion of patient folders from the OTOflex 100 memory, when memory is close to running full and a new patient folder is to be created. Old patient folders are deleted according to the following rules:

First ear to test

If set to Off, only patient results that have been safely documented, which means either saved to the PC or printed, will be deleted automatically without prompting. For other patient results, a message will inform you saying

“Memory full!”

If set to On, deletion will always take place without prompting for permission.

Default: On

Defines the first ear to be tested on a new patient.

226 Hz tymp unit

226 Hz defl(ection) unit

Default: Right

Select the unit for 226 Hz tympanometry: mmho, cc, ml, cm

3

.

Default: mmho

Select the unit for 226 Hz reflex measurements: mmho, cc, ml, cm

3

, l.

Default: mmho

143

Immittance test setup in MADSEN OTOflex 100

General actions

144

Intensity safety

Quick flow settings

On:

When Intensity safety is on, no stimulus intensities higher than 115 dB SPL (measured in a 2cc cavity) can be selected or will be applied.

Off:

When Intensity safety is off, stimulus intensities up to the technical limits of the device and probe can be selected and applied. A warning triangle is displayed on-screen whenever intensities above 115 dB SPL are selected.

Intensity safety is automatically set to On whenever the

Ear Selector

button is toggled or a new patient folder is selected.

Note ·

• Whenever a stimulus level exceeds the warning level

(> 108 dB SPL re 2cc), the stimulus intensity value will start flashing and all automatic testing is paused.

You are then prompted to decide whether to continue or to move on to the next stimulus type.

• In Manual testing, whenever a stimulus level exceeds the Intensity Safety level ((> 115 dB SPL re 2cc), the stimulus intensity value will start flashing.

Warning ·

When you test on small ears, the sound pressure level will increase in the ear canal. It is therefore not recommended to exceed the warning level when testing on patients with small ear canals.

Default: On

See 6.3.5 Test flow setup  59 for a description of the set-

tings below.

• ‘Done?’ prompt

• Print when done

• ‘Patient’ prompt

• ‘Settings’ prompt

12.2.3

Advanced..

These settings apply regardless of the test type or sequence selected. To access these settings:

Otometrics

• Select

Menu > Advanced..

Start Sequence

Test Selector

Printers..

Patient & User..

My Settings..

Done!

Probe check

-----------------------------

Probe tone

..

..

More Settings..

-----------------------------

Manage Test Results..

Procedure Options..

Advanced..

Immittance test setup in MADSEN OTOflex 100

General actions

Dissociate from

Users..

Device Settings..

Service..

Dissociate from

PC

Users..

Device Settings

Service.. (password protected)

If selected, any user trying to connect and control

OTOflex 100 will get a warning

• > Create New User..

See

3.2.3 The Text Editor  29 on how to enter text

in the fields in this screen.

• > Delete User..

Scroll to select the user to be deleted and press

Select

.

Accesses a menu, where the items relate to the settings of

the test device in general. See 12.2.4 Device settings  145 .

This menu item is for service purposes only.

12.2.4

Device settings

These settings apply regardless of the test type or sequence selected. To access these settings:

• Select

Menu > Advanced.. Device Settings..

Otometrics

145

Immittance test setup in MADSEN OTOflex 100

General actions

Device Info.

Brightness

Wheel click vol.

Button click vol.

Bluetooth

Battery type

Altitude ab. sea

Bat(tery) power save

Displays technical information about hardware, firmware and Bluetooth.

For adjusting the brightness of the display.

For adjusting the wheel click volume.

For adjusting the button click volume.

Defines whether Bluetooth communication is on or off.

Allows you to completely disable Bluetooth communication in case OTOflex 100 is to be used in extremely radio sensitive environments.

NiHM or Alka(line). Must be set according to the battery type inserted in the battery compartment. If

OTOflex 100 suspects that the setting is wrong (based on battery voltage checks), you will be prompted once for selection of the battery type.

The altitude above sea level affects the barometric pressure and thus the air density. This setting is used to optimize the pump operation according to the current air density.

The setting is listed in increments of 100 meters (100 meters = approx. 330 ft).

-100 to 4000 metres.

This setting applies when OTOflex 100 is running on battery power. After this time period in active mode without any user actions on OTOflex 100 or via OTOsuite,

OTOflex 100 will enter power save mode where the display changes to a power save screen and the auto start and auto resume functions stop working. Power save mode reduces power consumption and preserves battery capacity.

Recommended setting: 3 minute or as short as possible.

If the battery capacity is low, OTOflex 100 will power off instead of entering power save.

Press any key or operate OTOflex 100 from OTOsuite to resume full operation.

146

Otometrics

Otometrics

Immittance test setup in MADSEN OTOflex 100

General actions

Bat(tery) power off

This setting applies when OTOflex 100 is running on battery power. After this time period in power save mode

OTOflex 100 will power off. Power off preserves battery capacity.

Ch(ar)g(er) power save

Recommended setting: 7 minutes or as short as possible.

This setting applies when OTOflex 100 is placed in a powered charger and uses rechargeable batteries. After this time in active mode without any user actions on

OTOflex 100 or via OTOsuite, OTOflex 100 will enter power save mode where the display changes to a power save screen and the auto start and auto resume functions stop working. Power save mode reduces power consumption and allows the batteries to charge.

Note ·

OTOflex 100 will only charge while in power save or while turned off. In active mode, the batteries will still loose power.

Recommended setting: 5 minutes or as short as possible.

Ch(ar)g(er) power off

Press any key or operate OTOflex 100 from OTOsuite to resume full operation.

This setting applies when OTOflex 100 is placed in a powered charger and uses rechargeable batteries. After this time period in power save mode, OTOflex 100 will power off. Power off allows the batteries to charge and prolongs device lifetime.

No power off before

Recommended setting: 60 minutes or as short as possible.

This setting applies when OTOflex 100 is placed in a powered charger and uses rechargeable batteries.

Prevents automatic power off until a certain hour of the day.

Adjust the setting to the end of your typical working day if you like to keep OTOflex 100 powered and ready for use during working hours.

Set it to 0 to always allow automatic power off.

147

Immittance test setup in MADSEN OTOflex 100

Tympanometry setup

Localization

Menu item with access to:

Set time

Calib. old warning

Load factory settings

• Language selection

• Date setting

• Probe standard

ISO, ANSI, or Ref. EAR-3A.

Set the year, month, day, hour format, hour and minute settings.

For setting up he device to warn when the calibration is one year old. Default is On.

For loading the preset factory settings.

12.3

Tympanometry setup

When you perform a tympanometry sweep, there are a number of settings you can adjust.

Probe Tone

Menu >

Scroll to select the appropriate frequency for this measurement setup.

Adult default:226 Hz

Infant default:1000 Hz

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc or cm

3

as described in

App.

2.2 Tympanometry  222

.

For frequencies higher than 226 Hz, admittance is shown

only in mmho. The value on the Admittance scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than 4-

6 months. See also

App. 2.2.1 Tympanometry testing on infants  222 .

148

Otometrics

Otometrics

Immittance test setup in MADSEN OTOflex 100

Tympanometry setup

Baseline comp(ensation)

Tymp scale

Layered curves

Menu >

On:

The middle ear admittance alone (after subtraction of the ear canal contribution) is measured.

Off:

The total ear admittance (including the ear canal) is measured.

Default: On

Menu >

This setting follows unit, probe tone, and baseline comp. settings.

Default: 1.5 mmho 226 Hz

Default: 3.0 mmho 1000 Hz

Menu >

When

Layered curves

is On, this affects a number of areas:

• If

Auto scale

is checked, the graph will be scaled to allow for showing the highest curve. Auto scaling is still ear dependent.

• If a 1000 Hz tympanogram is included among the layered curves, the applicable units and tymp results labels for 1000 Hz probe tone measurements will also be used for the 226 Hz curves.

• The widest pressure range used will be applied.

The selected curve is highlighted and shown as a bold full line.

Note ·

This setting is not saved as part of a measurement setup.

Default: On

149

Immittance test setup in MADSEN OTOflex 100

Tympanometry setup

Auto next curve

Press(ure) range

Custom min. press(ure)

Custom max. press(ure)

Menu > More settings..

Select On or Off to define whether the system will automatically select the next curve number available for the new measurement results when you press

Start

to start a new measurement.

Example:

If the setting is Off, and the curve number shown is no. 3, the results currently applying to this number will be overwritten.

Default: On

Menu > More settings..

The pressure range selected in the measurement setup.

You can choose between

Normal

and

Custom

pressure range.

Normal

The normal range of pump pressure is from -

400 daPa to +200 daPa.

Custom

The custom range (Custom min. press. and Custom max. press. settings, listed below) can be accessed if

Custom

is selected.

You can extend the pressure range of –400 to +200 daPa to as much as –600 to +400 daPa, or decrease it to -50 to

+50 daPa.

Default: Normal

Menu > More settings..

Custom minimum pressure ranges from -50 to -600 daPa in steps of 50 daPa.

Default: -600 daPa

Menu > More settings..

Custom maximum pressure ranges from +50 to +400 daPa in steps of 50 daPa.

Press

Select

and scroll to the appropriate pressure value.

Default: 400 daPa

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Immittance test setup in MADSEN OTOflex 100

Tympanometry setup

Pump speed

Sweep direction

Norm type

Menu > More settings..

Changes the speed of the pressure sweep. Indicated in daPa per second.

• 50, 100, 200, 400 daPa/s, or

• AFAP (As Fast As Possible, 500-600 daPa/s in 2 - 0.5 cc): Forces the pump to work as fast as possible. The actual pressure build-up depends on the amount of air escaping from probe and ear.

Infant default: AFAP daPa/s

Adult default: 200 daPa/s

Menu > More settings..

The air pressure determines the direction of the pressure sweep from a positive value to a negative value or vice versa.

Stop when results

(are available)

• positive - from a negative towards a positive value

• negative - from a positive towards a negative value

Default: Negative

Menu > More settings..

The measurement stops automatically when satisfactory values have been registered.

Tymp auto scale

Default: On

Menu > More settings..

Enables automatic rescaling to an appropriate value in order to show the entire curve.

Note ·

The autoscaling adjusts dynamically according to the highest of all currently displayed curves, so that you can visually compare ear results.

Default: Off

Menu > More settings..

None or Jerger. For controlling whether auto classification is performed and according to which norm.

Default: Jerger

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Tympanometry setup

Show Norm Area

Menu > More settings..

Switch for displaying the normative area in the graph.

Important ·

This setting is not saved as part of a test setting.

12.3.1

Screening tympanometry

When you perform tympanometric screening, there are a number of settings you can adjust.

The following settings are relevant:

Sequence

Menu > Procedure Options..

Select

T+RS

Auto start on seal

Menu > Procedure Options..

Select On.

Stop when results

(are available)

Pump speed

Menu > More Settings..

Select On.

Menu > More Settings..

Select AFAP (As Fast As Possible)

12.3.2

ETF-I setup

When you perform an ETF-I test, there are a number of settings you can adjust.

Layered curves

Auto next curve

(when starting new measurement)

Sweep direction

Menu >

Set to On to enable a typical ETF-I setting with layered tympanograms.

Note ·

This setting is not saved as part of a measurement setup.

Menu > More Settings..

Select

On

or

Off

to define whether the system will automatically select the next curve number available for the new measurement results.

Menu > More Settings..

Make sure that the same sweep direction is used for all the curves to be compared.

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12.4

Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Screening setup

Acoustic Reflex Screening setup

When you perform a Reflex Screening measurement, there are a number of settings you can adjust.

Auto start on seal

Menu > Procedure options > Auto start on seal

Typically for use with screening eartips.

Auto resume on seal

Recommended setting: Sequence, with T+RS sequence selected.

Menu > Procedure options > Auto resume on seal

Off: The screening eartip must remain in place against the patient’s ear. If the probe is removed, the test is interrupted.

Probe Tone

Stimulus 1 - 5

On: If the screening eartip is removed from the patient’s ear, the test continues from the intensity it came to or was interrupted in, when there is seal.

Menu

Scroll to select the appropriate frequency for this measurement setup.

Adult default:226 Hz

Infant default:1000 Hz

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc, cm

3

or l.

For frequencies higher than 226 Hz, admittance is shown

only in mmho. The value in Admittance scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than 4-

6 months. See also

App. 2.2.1 Tympanometry testing on infants  222 .

Menu > More settings..

Select the stimulus types to be included. See the following.

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Acoustic Reflex Screening setup

Stimulus side

Stimulus 1

Menu > More settings..

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, BBN.

Default: 1000 Hz

Stimulus 2

Menu > More settings..

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, BBN, Off.

Default: 2000 Hz

Stimulus 3

Menu > More settings..

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, BBN, Off.

Default: 4000 Hz

Stimulus 4

Menu > More settings..

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, BBN, Off.

Default: 500 Hz

Stimulus 5

Menu > More settings..

500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, BBN, Off.

Default: Off

Menu > More settings..

Ipsi, Contra, Ipsi then Contra, Contra then Ipsi (diagnostic version only).

Default: Ipsi

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Acoustic Reflex Screening setup

Max intensity

No. of intensities

Intensity increment

Menu > More settings..

Select the required maximum level of the stimulus intensity (up to 100 dB).

Default: 95 dB HL

The test is interrupted at Max level and must be continued manually.

Warning ·

Be careful when you enter the Max setting, so as not to expose the patient to too high intensity levels!

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL.

Menu > More settings..

1, 2 or 3. Define whether you wish to use more than one intensity during testing.

If set to 1, testing uses only max intensity.

If set to 2, testing starts at max intensity - intensity increment and continues with max intensity if no reflex was found.

If set to 3, testing starts at max intensity - 2 * intensity increment and continues up to max intensity or until a reflex is detected.

Default: 1

Menu > More settings..

Select the step size to increment the stimulus intensity

(Sound Pressure Level) in increments of 10, 15, or 20 dB.

Default: 10 dB

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Acoustic Reflex Threshold setup

Reflex criterion

Menu > More settings..

Enter the appropriate setting for the reflex criterion. It follows unit and probe tone settings.

The applicable unit (mmho, cc, ml, cm

3

or l) is selected automatically, when “Unit” is set.

If l is used for 226 Hz probe tone, then all values are multiplied by 1000.

Default criterion: ±0.02 mmho

12.5

Acoustic Reflex Threshold setup

When you perform a Reflex Threshold measurement, there are a number of settings you can adjust.

Probe Tone

Menu >

Scroll to select the appropriate frequency for this measurement setup.

Adult default:226 Hz

Infant default:1000 Hz

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc, cm

3

or l.

For frequencies higher than 226 Hz, admittance is shown

only in mmho. The value in Y scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than 4-

6 months. See

App. 2.2.1 Tympanometry testing on infants  222 .

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Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Threshold setup

Use TPP offset

TPP offset

Pump during stim(ulation)

Reflex criterion

Menu >

Select or deselect the use of pressure offset to stabilise the eardrum. To change the current setting, select

Menu >

More settings.. TPP offset

(see also description below).

Off: TPP is used if available

On: TPP + TPP offset (according to TPP sign) are used

Default value: On

Menu > More settings..

Select a pressure offset to stabilise the eardrum. This may facilitate reflex recordings from ears showing steeply sloped tympanograms. A positive value offsets in same direction as TPP sign.

-50 < x < 50 daPa (offset according to TPP sign)

Default value: 20 daPa

Menu > More settings..

On/Off

If On, the pump will actively keep the TPP pressure even during stimulus presentation.

If Off, the pump will adjust the pressure between presentations.

Default value: Off (pump kept inactive during the stimulus period)

Menu > More settings..

Enter the appropriate setting for the reflex criterion.

The dashed horizontal line in each reflex graph indicates the predefined reflex criterion. It is therefore offset from the base line marker on the vertical axis. The degree of offset is influenced by this setting.

The applicable unit (mmho, cc, ml, cm

3

or l) follows unit and probe tone settings.

Default criterion: ±0.02 mmho

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Acoustic Reflex Threshold setup

Deflection scale

Show 500 Hz

Show 1000 Hz

Show 2000 Hz

Show 3000 Hz

Menu > More settings..

Defines the size of the admittance scale for reflex measuring.

The applicable unit (mmho, cc, ml, cm

3

or l) follows unit and probe tone settings.

If l is used for 226 Hz probe tone, then all values are multiplied by 1000.

Default: -0.15 mmho for 226 Hz probe tone

Default: -0.30 mmho for 1000 Hz probe tone

Menu > More settings..

Select the stimulus type to be included in manual threshold testing.

Default: On

Menu > More settings..

Select the stimulus type to be included in manual threshold testing.

On/Off

Default: On

Menu > More settings..

Select the stimulus type to be included in manual threshold testing.

On/Off

Default: Off

Menu > More settings..

Select the stimulus type to be included in manual threshold testing.

On/Off

Default: Off

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Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Threshold setup

Show 4000 Hz

Show BBN

Show LBN

Show HBN

Pre-stim(ulus) time

Stim(ulus) time

Menu > More settings..

Select the stimulus type to be included in manual threshold testing.

On/Off

Default: Off

Menu > More settings..

Select or deselect Broad Band Noise to be included in manual threshold testing.

On/Off

Default: Off

Menu > More settings..

Select or deselect Low Band Noise to be included in manual threshold testing.

On/Off

Default: Off

Menu > More settings..

Select or deselect High Band Noise to be included in manual threshold testing.

On/Off

Default: Off

Menu > More settings..

Defines the recording time before each stimulus is presented.

Default value: 0.2 seconds

Menu > More settings..

Defines the duration of the stimulus. Displays the text

“Manual” when set to 0.

Default value: 1.3 seconds

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Acoustic Reflex Threshold setup

Post-stim(ulus) time

Stimulus 1 - 8

Menu > More settings..

Defines the recording time after each stimulus is terminated.

Default value: 0.5 seconds

Menu > More settings..> Auto Settings..

Select the stimulus types to be included. See the following.

Stimulus 1

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN.

Default: 1000 Hz

Stimulus 2

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: 2000 Hz

Stimulus 3

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: 4000 Hz

Stimulus 4

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: 500 Hz

Stimulus 5

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: Off

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Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Threshold setup

Stimulus side

Max. intensity

Stimulus 6

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: Off

Stimulus 7

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: Off

Stimulus 8

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN,

LBN, HBN, Off.

Default: Off

Menu > More settings..> Auto Settings..

I, C, I - > C, C - > I

(Ipsi, Contra, Ipsi then Contra, Contra then Ipsi)

Default: I(psi)

Menu > More settings..> Auto Settings..

Select the required maximum level of the stimulus intensity (up to 105 dB HL).

Default: 105 dB HL

Note ·

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL. This intensity level is below the warning level for all available stimuli.

Automatic testing always stops after presenting the stimulus at the Max. intensity. For safety reasons, testing at higher intensities is possible only in manual mode.

Warning ·

When testing manually, be careful when you select the Stimulus intensity so as not to expose the patient to too high intensity levels!

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Acoustic Reflex Threshold setup

Start intensity

Intensity Increment

Verification

Pause-time

Note ·

Whenever a stimulus level exceeds the warning level

(> 108 dB SPL re 2cc), the stimulus intensity value will start flashing and all automatic testing is paused. You are then prompted to decide whether to continue or to move on to the next stimulus type.

In Manual testing, whenever a stimulus level exceeds the

Intensity Safety level ((> 115 dB SPL re 2cc), the stimulus intensity value will start flashing.

Menu > More settings..> Auto Settings..

Select the required start level of the stimulus intensity

(from 40 to 105 dB).

Default: 70 dB HL

Menu > More settings..> Auto Settings..

Select the step size to increment the stimulus intensity in increments of 1, 2, 5, or 10 dB.

This setting also applies to Manual testing and Reflex

Decay testing.

Default: 5 dB

Menu > More settings..> Auto Settings..

Select the type of verification strategy to be used after the reflex criterion has been met by the automatic threshold search.

The stimulus may be retested for reproducibility, or the next one or two intensity levels can be used to confirm the reflex growth properties.

Settings: Off, Repeat, Include next, Include next 2.

Default: Incl. next

Menu > More settings..> Auto Settings..

Defines the inter-stimulus interval, i.e. the pause from the end of one measurement (after post-stim time has elapsed) to the start of the next (when pre-stim time starts).

Default value: 0.5 seconds

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12.6

Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Decay setup

Acoustic Reflex Decay setup

When you perform a Reflex Decay measurement, there are a number of settings you can adjust.

Probe Tone

Use TPP offset

TPP offset

Pump during stim.

Menu >

Decay can be measured only with a 226 Hz probe tone.

Default:226 Hz

With a probe tone at 226 Hz, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc, cm

3

or l.

Menu >

Select or deselect the use of pressure offset to stabilise the eardrum. To change the current setting, select

Menu >

More settings.. TPP offset

(see also description below).

Off: TPP is used if available

On: TPP + TPP offset (according to TPP sign) are used

Default value: On

Menu > More settings..

Select a pressure offset to stabilise the eardrum. This may facilitate reflex recordings from ears showing steeply sloped tympanograms. A positive value offsets in same direction as TPP sign.

-50 < x < 50 daPa (offset according to TPP sign)

Default value: 20 daPa

Menu > More settings..

On/Off

If On, the pump will actively keep the TPP pressure even during stimulus presentation.

If Off, the pump will adjust the pressure between presentations.

Default value: Off

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Immittance test setup in MADSEN OTOflex 100

Acoustic Reflex Decay setup

Deflection scale

Show 500 Hz

Show 1000 Hz

Pre-stim(ulus) time

Stim(ulus) time

Post-stim(ulus) time

Menu > More settings..

Enter the appropriate setting for the reflex decay deflection scale.

The applicable unit (mmho, cc, ml, cm

3

or l) follows unit and probe tone settings.

If l is used for 226 Hz probe tone, then all values are multiplied by 1000.

If a negative scale is selected, the graph by default leaves room for negative deflections and vice versa. However, the zero axis will automatically move if the deflection graph should go in the opposite direction.

Default: -0.30 mmho

Menu > More settings..

Select the stimulus type to be included in reflex decay testing.

Default: On

Menu > More settings..

Select the stimulus type to be included in reflex decay testing.

Default: On

Menu > More settings..

Defines the recording time before each stimulus is presented.

Default value: 1.0 seconds

Menu > More settings..

Defines the duration of the stimulus.

Default value: 5.0 seconds

Menu > More settings..

Defines the recording time after each stimulus is terminated.

Default value: 1.0 seconds

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Immittance test setup in MADSEN OTOflex 100

ETF-P setup

Stimulus 1

Stimulus 2

Stimulus side

Pause-time

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz.

Default: 500 Hz

Menu > More settings..> Auto Settings..

500 Hz, 1000 Hz, Off.

Default: 1000 Hz

Menu > More settings..> Auto Settings..

I, C, I - > C, C - > I

(Ipsi, Contra, Ipsi then Contra, Contra then Ipsi)

Default: I(psi)

Menu > More settings..> Auto Settings..

Defines the inter-stimuli interval.

Default value: 0.5 seconds

Note ·

The

Intensity increment

used in Reflex Decay is set in the Acoustic Reflex Threshold setup. This is because the

Reflex Decay stimulus level defaults to the reflex threshold

+10 dB.

Warning ·

When testing manually, be careful when you select the Stimulus intensity so as not to expose the patient to too high intensity levels!

Note ·

• Whenever a stimulus level exceeds the warning level

(> 108 dB SPL re 2cc), the stimulus intensity value will start flashing and all automatic testing is paused.

You are then prompted to decide whether to continue or to move on to the next stimulus type.

• In Manual testing, whenever a stimulus level exceeds the Intensity Safety level ((> 115 dB SPL re 2cc), the stimulus intensity value will start flashing.

12.7

ETF-P setup

When you perform an ETF-P measurement, there are a number of settings you can adjust.

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Immittance test setup in MADSEN OTOflex 100

Test sequences

Initial pressure

Pos(itive) Pressure

Neg(ative) pressure

Pump speed

Initial time scale

Menu >

The pressure used for the first part of the test.

Default value: Pos(itive)

Menu >

Select the maximum positive pressure to be presented to the ear canal/middle-ear cavity.

100 to 400 daPa, presented in 50 daPa increments.

Default: 400 daPa

Menu >

Select the maximum negative pressure to be presented to the ear canal/middle-ear cavity.

-100 to -600 daPa, presented in 50 daPa increments.

Default: -400 daPa

Menu >

Changes the speed of the pressure sweep. Indicated in daPa per second.

See

App. 2.4 ETF-P (Eustachian Tube Function -

Perforated)  229 .

Note ·

It is highly recommended that the lowest setting (50 daPa/s) is always used for ETF-P.

Default: 50 daPa

Menu >

30-60 seconds. If the test exceeds the time axis, the axis will expand automatically to show first 40 seconds, then

50 and finally 60 seconds.

Any of the settings available can be predefined for the axis.

Default value: 30 seconds.

12.8

Test sequences

The OTOflex 100 tests are available as test sequences, where individual test types are combined into one sequence.

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Immittance test setup in MADSEN OTOflex 100

Test sequences

A sequence is a predefined set of automatic tests, using current test settings.

OTOflex 100 will always perform the most recently selected sequence, regardless of whether it has been selected in OTOflex 100 or in OTOsuite.

You can choose between the following sequences:

Tympanometry + Reflex Screening

Practical for basic hearing assessment.

Tympanometry + Reflex Thresholds

For full diagnostic hearing evaluation.

Tympanometry + Reflex Threshold + Reflex Decay

For full diagnostic hearing evaluation with suspicion of retrocochlear disorder.

Note ·

The Reflex Thresholds must be included in the test sequence in order to measure

Reflex Decay, since the decay stimulus levels are based on thresholds.

12.8.1

Selecting a sequence setup

You can select sequences, and thus define which tests are to be performed in a battery of tests.

1. Select

Menu > Procedure Options.. > Sequence

.

2. Press

Select

and scroll to view the appropriate sequence. You can choose between

T + RS

(Tympanometry + Reflex Screening)

T + RT

(Tympanometry + Reflex Threshold)

T + RT + RD

(Tympanometry + Reflex Threshold + Reflex Decay)

3. Press

Select

to select the sequence.

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Immittance test setup in MADSEN OTOflex 100

Test sequences

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13 Immittance Module Tools Options

(view and measurement options)

13.1

General settings

These settings apply regardless of the test type or sequence selected.

1. To change general settings, select

Tools > Options > Immittance > General

or click the

Set Options

icon on the toolbar.

2. The

Options

dialog appears.

3. Click on

Immittance > General

.

13.1.1

Available settings

Measurement settings

Auto Settings

Auto resume on seal

Auto start on seal

If set to On, and a measurement is paused by a leak, the test or sequence is automatically resumed when the probe is properly refitted in the ear canal.

The system automatically starts the measurement as good seal is obtained in the ear canal. Regardless of the setting in

Tools > Options > Tymp. and Reflex Scr. >

Auto next curve

, the Immittance Module automatically changes to the next tymp curve for each tymp sweep.

This is to prevent overwriting already recorded tymps, if a tymp measurement is triggered by accident.

This setting is part of the measurement setting. Depending on the selected test setting, define this setting to suit the specific test setting purposes.

First ear to test

First ear to test

Defines the first ear to be tested on a new patient.

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Immittance Module Tools Options (view and measurement options)

General settings

General

Settings Name

Enter the term/name to be used for settings saved as a setup in OTOflex 100.

Safety

Intensity safety

On:

When Intensity safety is on, no stimulus intensities higher than 115 dB SPL (measured in a 2cc cavity) can be selected or will be applied.

Off:

When Intensity safety is Off, stimulus intensities up to the technical limits of the device and probe can be selected and applied. A warning triangle is displayed onscreen whenever intensities above 115 dB SPL are selected.

Default: On

Warning ·

When you test on small ears, the sound pressure level will increase in the ear canal. It is therefore not recommended to exceed the warning level when testing on patients with small ear canals.

Intensity safety is automatically set to On whenever the

Ear Selector

icon is toggled or a new patient folder is selected.

Note:

• Stimulus levels at or above the warning level

(> 108 dB SPL re 2cc) are marked by an orange bar in the

Intensity

drop-down list.

• Stimulus levels at or above the intensity safety level

(> 115 dB SPL re 2cc) are marked by a red bar in the

Intensity

drop-down list.

Whenever a stimulus level exceeds the warning level, all automatic testing is paused. You are then prompted to decide whether to continue or to move on to the next stimulus type.

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Immittance Module Tools Options (view and measurement options)

View settings

13.2

View settings

13.2.1

Tymp. and Reflex Scr. view settings

Tympanometry

Admittance axis

Admittance axis

The admittance axis can be configured to exclude the ear canal component. This is called Baseline compensation.

Baseline compensation must be selected to get the static admittance which is used in normative data such as the modified Jerger.

In contrast, the No compensation mode includes the total admittance (including the ECV).

You can set the scaling of each view setting individually.

When defining the view of the admittance axis, you can enable either

Not compensated

or

Baseline compensated

.

Baseline compensated

Enabling

Baseline compensated

displays a tympanogram view showing the compensated admittance curve as measured at the tympanic membrane level.

The tympanometric peak in the graph will represent the estimated admittance of the middle ear only. See the description of

Static Admittance

in the OTOflex 100 documentation.

Not compensated

Select Baseline compensated to access the fields

Scale

(Baseline compensated)

,

B/G numeric component compensation for Y

and

Show normal area

.

Select to display a tympanogram showing the total admittance curve as measured at the probe tip level.

The tympanometric peak in the graph will represent the total admittance of the ear canal and the middle ear.

Select Not compensated to access the field

Scale (Not compensated)

setting.

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Immittance Module Tools Options (view and measurement options)

View settings

Admittance axis

B/G numeric component compensation for Y

Scale (Baseline compensated)

Scale (Not compensated)

Show norm area

Calculates the middle ear admittance by subtracting the susceptance (B) and conductance (G) individually from the baseline reference B and G values (recommended for baseline compensation in 1000 Hz tympanometry).

Note ·

The curve will never have negative admittance values, since any difference from a reference point is always positive. That is why the curve may not look like a traditional tympanogram at the negative tail. This is perfectly normal.

This strategy is more important when using high frequency probe tones (to account for phase shifts during the pressure sweep), but can also be used for 226 Hz.

Phase shifts are much smaller when using 226 Hz and have traditionally been considered negligeable. Hence, common subtraction of admittance (Y) is typically used for baseline compensation although it is not as correct.

The two different scale values separated by a slash (e.g.

3.0/6.0) are probe tone dependent. The first value applies when 226 Hz probe tone is used, the second applies when 1000 Hz is used.

Auto scale

icon

Enables automatic rescaling to an appropriate value in order to display the entire curve.

The two different scale values separated by a slash (e.g.

3.0/6.0) are probe tone dependent. The first value applies when 226 Hz probe tone is used, the second applies when 1000 Hz is used.

When tympanograms are displayed with a scale of 1.5 or

3.0 mmho (or cc/cm

3

/ml), the graph will show an axis complying with the standard ANSI aspect ratio, where 1 mmho corresponds to 300 daPa in magnitude.

For selecting/deselecting display of the norm area in the graph.

The modified Jerger normative data applies to 226 Hz only.

Select to enable the

Selected Norm Region

list.

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Immittance Module Tools Options (view and measurement options)

View settings

Admittance axis

Selected Norm Region

Possible selection: Adult, 226 Hz, which is based on the

Jerger norm. For controlling whether auto classification is performed and according to which norm.

The

Show norm Area

result is directly linked to the

Adult, 226 Hz norm. This is because the tympanometric type classification is defined by the TPP relation to the range of the norm data.

Unit

Changes the admittance/compliance unit on the vertical axis for 226 Hz probe tone use. See the description of admittance/compliance in the OTOflex 100 Guide.

Curves

Layered curves Enables a typical ETF-I setting with layered tympanograms.

When

Layered curves

is checked, this affects a number of areas:

• If the

Autoscale tympanogram

icon is selected, the graph will be scaled to allow for showing the highest curve. Auto scaling is still ear dependent.

• If a 1000 Hz tympanogram is included among the layered curves, the applicable units and tymp results labels for 1000 Hz probe tone measurements will also be used for the 226 Hz curves.

• The widest pressure range used will be applied.

When

Layered curves

is enabled, the curves are denoted by the following graphical conventions:

Curve 1

Full line

Curve 2

Dotted line

Curve 3

Dashed line

The selected curve is highlighted and shown as a bold full line.

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Immittance Module Tools Options (view and measurement options)

View settings

Pressure axis

Range Enables using the same aspect ratio for all pressure sweeps, regardless of whether they are for instance

+200 to -400 or +400 to -600.

If the +200 to -400 range is selected, but a wider custom pressure range is used, the pressure scale will automatically be set to +400 to -600.

Acoustic Reflex Screening view settings

Reflex screening table

Always show Lists the stimulus types that are always shown. In addition, any measured stimulus types are also shown automatically.

Select and deselect stimulus types. One stimulus type must always be selected as a minimum.

ETF-I view settings

No special settings are needed for ETF-I tests, except for the following:

Curves

Layered curves Enables a typical ETF-I setting with layered tympanograms.

13.2.2

Reflex Threshold view settings

Deflection axis

Scale (226/1000 Hz)

Unit

The two different scale values separated by a slash (e.g.

3.0/6.0) are probe tone dependent. The first value applies when 226 Hz probe tone is used, the second applies when 1000 Hz is used.

• For 226 Hz probe tone: the units available are: mmho, cc, ml, cm

3

and l.

• For 1000 Hz probe tone: the unit mmho is always used.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Threshold table

Always show

Lists the stimulus types that are always shown. In addition, any measured stimulus types are also shown.

Select and deselect stimulus types. One stimulus type must always be selected as a minimum.

13.2.3

Reflex Decay view settings

Decay table

Always show Lists the stimulus types that are always shown. In addition, any measured stimulus types are also shown.

Select and deselect stimulus types. One stimulus type must always be selected as a minimum.

Deflection axis

Scale

Unit

For defining the scale setting relating to the unit used above.

For 226 Hz probe tone: the units available are: mmho, cc, ml, cm

3

and l.

13.2.4

ETF-P view settings

Time axis

Scale (sec.) When the end of the time axis is reached, it will automatically extend with 10 more seconds up to the max time value, 60 seconds.

The graph can be rescaled to show more detail, even after the measurement has been completed.

Default value: 30 seconds.

13.3

Measurement settings

Measurement settings are your way of defining how the test results should be carried out.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

13.3.1

Tympanometry setup

When you perform a tympanometry sweep, there are a number of settings you can adjust. These settings are available either in the

Control Panel

on the left side of the screen, or in the

Tools > Options > Tymp. and Reflex Scr.

dialog.

13.3.1.1

Tympanometry: Control panel settings

Probe Tone

226 Hz

1000 Hz

Select the frequency for this measurement setup.

Adult default

Infant default

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc or cm

3

as described in 13.2.1 Tymp. and Reflex Scr. view settings  171 .

For frequencies higher than 226 Hz, admittance is shown only in mmho. The value in Y scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than

4-6 months. See also the OTOflex 100 Guide.

Pump speed

Changes the speed of the pressure sweep. Indicated in daPa per second.

• 50, 100, 200, 400 daPa/s, or

• AFAP (As Fast As Possible, 500-600 daPa/s in 2 - 0.5 cc): Forces the pump to work as fast as possible. The actual pressure build-up depends on the amount of air escaping from probe and ear.

Default: AFAP daPa/s

Pressure range

You can choose between

Normal

and

Custom

pressure range:

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Pressure range

Normal

Custom

Custom range

• where the pressure range settings are disabled unless

Custom range

is enabled.

• Shows the pressure range selected in the measurement setup that is currently used. The normal range of pump pressure is from -400 daPa to +200 daPa.

• where you can access and change these values. To do so, enable

Custom range

.

Enable to access and change the values in the

Pressure range

fields.

You can extend the pressure range of –400 to +200 daPa to as much as –600 to +400 daPa, or decrease it to -50 to

+50 daPa in steps of 50 daPa.

Default min. pressure: -600 daPa

Default max. pressure: 400 daPa

Sweep direction

The air pressure determines the direction of the pressure sweep from a positive value to a negative value or vice versa.

• positive - from a negative towards a positive value

• negative - from a positive towards a negative value

Default: Negative

13.3.1.2

Tympanometry: Test settings

Click icon or select

Tools > Options > Tymp. and Reflex Scr. > Measurement

Tympanometry

Auto next curve Enable or disable to define whether the system will automatically select the next curve number available for the new measurement results when you press

Start

to start a new measurement.

The Tympanometry graph shows a maximum of 3 curves per ear per patient

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Tympanometry

Stop when results are available

Off

Recorded tympanograms will always be stored in the selected curve number overwriting any previous graph in that curve memory. You must toggle the

Curve selector

on the toolbar to the next curve number to preserve a previously recorded tymp.

On

Every time a new measurement is initiated, the curve number is advanced automatically before the tympanogram is recorded (except if the current curve memory is empty). In this way, the first 3 tympanograms recorded are automatically stored. If you continue measuring, the curve number is cyclically increased and older tympanograms overwritten.

Default: On

The measurement stops automatically when satisfactory values have been registered.

13.3.1.3

Screening tympanometry

If this test is made in conjunction with Reflex screening, the following settings are needed:

Pump speed

In the dropdown list on the

Control Panel

select

AFAP

(As Fast As Possible)

Auto resume on seal

Select

Tools > Options > General > Measurement

and enable this function. This function is ideal for speeding up the test procedure.

Autostart on seal

Select

Tools > Options > General > Measurement

and select Sequence below the

Control Panel

.

Note ·

If you want to generate a very fast tympanogram, set

Autostart on seal

to

‘Tymp’ instead of ‘Sequence’.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Stop when results are available

Select

Tools > Options > Tymp. and Reflex Scr. > Measurement

and enable this function. The measurement stops automatically when satisfactory values have been registered.

13.3.2

ETF-I Setup

ETF-I tests are done using the standard Tympanometry view and test settings.

13.3.2.1

ETF-I: Control panel settings

No special settings are needed for ETF-I tests, except for the following:

Sweep direction

Make sure that the same sweep direction is used for all the curves to be compared.

13.3.2.2

ETF-I: Test settings

Click icon or select

Tools > Options > Tymp. and Reflex Scr. > Measurement

No special settings are needed for ETF-I tests, except for the following:

Auto next curve

Enable

Auto next curve

to facilitate recording of multiple tympanograms. See

Auto next curve  179 .

13.3.3

Acoustic Reflex Screening setup

When you perform a Reflex Screening measurement, there are a number of settings you can adjust. These settings are available either in the control panel on the left side of the screen, or in the

Tools > Options > Tymp. and Reflex Scr. > Measurement

dialog.

13.3.3.1

Acoustic Reflex Screening: Control panel settings

Probe Tone

226 Hz

1000 Hz

Click the appropriate radio button to select the frequency for this measurement setup.

Adult default

Infant default

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Measurement settings

180

Probe Tone

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc, cm

3

or l as described in

13.3.1.2 Tympanometry: Test settings  177

.

For frequencies higher than 226 Hz, admittance is shown only in mmho. The value in Y scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than

4-6 months. See also the OTOflex 100 Guide.

13.3.3.2

Acoustic Reflex Screening: Test settings

Click icon or select

Tools > Options > Tymp. and Reflex Scr. > Measurement

Auto Reflex Screening

Reflex criterion

(mmho

Enter the appropriate setting for the reflex criterion. It follows unit and probe tone settings.

Default: ±0.02 mmho

Stimulus intensities

Start Depending on the increment selected, you can select or deselect the intensity. You can select up to three stimulus intensities. The complete range of intensities available will appear when you deselect all.

When the list is shown, simply click on a specific intensity to select. Then consider which adjacent intensities you wish to include. The options will show according to the selected step size.

Note ·

You cannot extend the range to include stimulus levels exceeding 100 dB HL in this test.

Whenever the stimulus intensity level exceeds

108 dB SPL, for example when you select 100 dB HL at

500 Hz Ipsi, a warning will appear, and the automatic test is paused. You will be prompted whether to continue or skip to the next stimulus type.

Otometrics

Immittance Module Tools Options (view and measurement options)

Measurement settings

Stimulus intensities

Increment (dB)

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL.

Select the step size to increment the stimulus intensity

(Sound Pressure Level) in increments of 10, 15, or 20 dB.

Default: 10 dB

Stimulus side

Stimulus side

• Ipsi

Stimulus is presented in the probe ear where the measurements are made.

• Contra

Stimulus is presented through an ear phone or insert phone in the ear opposite to the probe ear.

• Ipsi then Contra

• Contra then Ipsi

Default: Ipsi

Stimulus types

Stimulus types

Select the stimulus types to be included/excluded. At least one stimulus type must always be selected.

Available types: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz,

BBN.

13.3.4

Acoustic Reflex Threshold setup

When you perform a Reflex Threshold measurement, there are a number of settings you can adjust. These settings are available either in the control panel on the left side of the screen, or in the

Tools > Options > Reflex Threshold > Measurement

dialog.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

13.3.4.1

Acoustic Reflex Threshold: Control panel settings

Reflex Threshold

Probe Tone

226 Hz

1000 Hz

Select the frequency for this measurement setup.

Adult default

Infant default

If 226 Hz is selected, you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml, cc, cm

3

or l as described in 13.2.2 Reflex

Threshold view settings  174 .

For frequencies higher than 226 Hz, admittance is shown only in mmho. The value in Y scale automatically changes to mmho.

• 226 Hz

• 1000 Hz

Recommended for testing on infants younger than

4-6 months. See also the OTOflex 100 Guide.

Custom TPP offset

Check or uncheck this checkbox to select/deselect the use of pressure offset to stabilise the eardrum. To change the TPP offset setting, if

Control Panel > Custom TPP offset

is checked, select

Tools > Options > Threshold >

Custom TPP offset

(see also description below).

Disabled: TPP is automatically set to 25 daPa more.

Enabled: TPP + TPP offset (according to TPP setting in

Tools > Options > Threshold > Custom TPP offset

) are used.

Default value: Checked

Manual mode

Stimulus

Select the stimulus types to be included.

Available types: 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz,

4000 Hz, BBN, LBN, HBN.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Stimulus

1000 Hz

BBN

Intensity

70 dB HL

70 dB HL

Adult default

Infant default

Select the stimulus intensity from the drop-down list.

Adult default

Infant default

• Stimulus levels at or above the warning level

(> 108 dB SPL re 2cc) are marked by an orange bar in the

Intensity

drop-down list.

• Stimulus levels at or above the intensity safety level

(> 115 dB SPL re 2cc) are marked by a red bar in the

Intensity

drop-down list.

Stimulus side

Ipsi

Ipsi

Auto

Stimulus side

• Ipsi

Stimulus is presented in the probe ear where the measurements are made.

• Contra

Stimulus is presented through an earphone or insert phone in the ear opposite to the probe ear.

Adult default

Infant default

• Ipsi

Stimulus is presented in the probe ear where the measurements are made.

• Contra

Stimulus is presented through an ear phone or insert phone in the ear opposite to the probe ear.

• Ipsi then Contra

• Contra then Ipsi

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Immittance Module Tools Options (view and measurement options)

Measurement settings

13.3.4.2

Reflex Threshold: Test settings

Click icon or select

Tools > Options > Reflex Threshold > Measurement

.

General

Pump during stimulus

Custom TPP offset

(daPa)

Reflex criterion

(mmho)

Yes/No

Default value: No

Select a pressure offset to stabilise the eardrum. This may facilitate reflex recordings from ears showing steeply sloped tympanograms. The TPP offset can be adjusted in increments of xx daPa more/less.

50 daPa more to 50 daPa less (offset according to TPP sign)

Default value: 35 daPa

Enter the appropriate setting for the reflex criterion. It follows unit and probe tone settings.

Default: ±0.02 mmho

Stimulus intensities

Start value

Increment value

End value

You can select the start and maximum stimulus intensities in fields directly below

Stimulus Intensities

.

Whenever the stimulus intensity level exceeds

108 dB SPL, for example when you select 100 dB HL at

500 Hz Ipsi, a warning will appear, and the automatic test is paused. You will be prompted whether to continue or skip to the next stimulus type.

To avoid automatic or semi-automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits, it is recommended that you set the max. intensity to 95 dB HL.

Select the required start level (from 40 to 110 dB).

Select the step size to increment the stimulus intensity

(Sound Pressure Level) in increments of 1, 2, 5, or 10 dB.

Default: 10 dB

Select the required maximum level (up to 110 dB).

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Stimulus intensities

Warning ·

Be careful when you enter the Max setting, so as not to expose the patient to too high intensity levels!

You can extend the range to 105 dB (120 dB in Contra).

If you do, a warning will appear on the screen, and the test screen will visually indicate that you are using extended range!

Stimulus Timing

Pre-stim(ulus time)

Defines the recording time before each stimulus is presented.

Stimulus (time)

Post-stim(ulus time)

Pause (time)

Default value: 0.2 seconds

Defines the duration of the stimulus. Displays the text

“Manual” when set to 0.

Default value: 1.3 seconds

Defines the recording time after each stimulus is terminated.

Default value: 0.5 seconds

Defines the inter-stimulus interval.

Default value: 0.5 seconds

Stimulus types (Automatic)

Click to select the stimulus types to be included/excluded. At least one stimulus type must always be selected.

Available types: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz,

BBN, LBN, and HBN.

Verification

Select the type of verification strategy to be used after the deflection criterion has been met by the automatic threshold search.

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Verification

The stimulus may be retested for reproducibility, or the next one or two intensity levels can be used to confirm the reflex growth properties.

Default: Do next level

13.3.5

Reflex Decay setup

When you perform a Reflex Decay measurement, there are a number of settings you can adjust. These settings are available either in the control panel on the left side of the screen, or in the

Tools > Options > Reflex Decay > Measurement

dialog.

13.3.5.1

Reflex Decay: Control panel settings

Acoustic reflex decay is tested using a 226 Hz probe tone. It is typically not recommended to perform supra threshold reflex testing, such as decay, on infants.

Reflex Decay

Custom TPP offset

Enable or disable to select/deselect the use of pressure offset to stabilise the eardrum. To change the TPP offset setting, if

Control Panel > Custom TPP offset

is

enabled, select

Tools > Options > Decay > Custom TPP offset

(see also description below).

Disabled: TPP is automatically set to 25 daPa more.

Enabled: TPP + TPP offset (according to TPP setting in

Tools > Options > Reflex Decay > Measurement > Custom TPP offset

) are used.

Default value: Enabled

Manual mode

Stimulus

1000 Hz

Not currently available

Select the stimulus types to be included.

Available types: 500 Hz, 1000 Hz.

Adult default

Infant default

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Intensity

Select the stimulus intensity from the drop-down list.

If no reflex threshold is available, the

Control Panel >

Intensity

setting is Off. This is useful for admittance monitoring.

Default: Threshold +10 dB, or OFF

• Stimulus levels at or above the warning level

(> 108 dB SPL re 2cc) are marked by an orange bar in the

Intensity

drop-down list.

• Stimulus levels at or above the intensity safety level

(> 115 dB SPL re 2cc) are marked by a red bar in the

Intensity

drop-down list.

Note ·

The Intensity increment used in Reflex Decay is set in the Acoustic Reflex Threshold setup. This is because the

Reflex Decay stimulus level defaults to the reflex threshold

+10 dB.

Stimulus side

Ipsi

Ipsi

• Ipsi

Stimulus is presented in the probe ear where the measurements are made.

• Contra

Stimulus is presented through an earphone or insert phone in the ear opposite to the probe ear.

Adult default

Infant default

13.3.5.2

Reflex Decay: Test settings

Click icon or select

Tools > Options > Reflex Decay > Measurement

.

General

Pump during stimulus

Yes/No

Default value: Off

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Immittance Module Tools Options (view and measurement options)

Measurement settings

General

Custom TPP offset

Stimulus side

Ipsi

Ipsi

Stimulus Timing

(sec.)

Pre-stim(ulus time)

50 daPa more to 50 daPa less (offset according to TPP sign)

Default value: 35 daPa

Select a pressure offset to stabilise the eardrum. This may facilitate reflex recordings from ears showing steeply sloped tympanograms. The TPP offset can be adjusted in increments of xx daPa more/less.

• Ipsi

Stimulus is presented in the probe ear where the measurements are made.

• Contra

Stimulus is presented through an ear phone or insert phone in the ear opposite to the probe ear.

• Ipsi then Contra

• Contra then Ipsi

Adult default

Infant default

Stimulus (time)

Defines the recording time before each stimulus is presented.

Default value: 0.2 seconds

Defines the duration of the stimulus. Displays the text

“Manual” when set to 0.

Post-stim(ulus time)

Pause (time)

Default value: 1.3 seconds

Defines the recording time after each stimulus is terminated.

Default value: 0.5 seconds

Defines the inter-stimulus interval.

Default value: 0.5 seconds

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Immittance Module Tools Options (view and measurement options)

Measurement settings

Stimulus types (Automatic)

Select the stimulus types to be included/excluded. At least one stimulus type must always be selected.

Available types: 500 Hz, 1000 Hz.

13.3.6

ETF-P setup

13.3.6.1

ETF-P: Control panel settings

Initial pressure

The pressure used for the first part of the test.

Positive pressure

Select the maximum positive pressure to be presented to the ear canal/middle-ear cavity.

0 to 400 daPa, presented in 50 daPa increments.

Default: 400 daPa

Negative pressure

Select the maximum negative pressure to be presented to the ear canal/middle-ear cavity.

-100 to -600 daPa, presented in 50 daPa increments.

Default: -400 daPa

13.3.6.2

ETF-P: Test settings

Click icon or select

Tools > Options > ETF-P > Measurement

.

Pump speed (daPa/s)

Changes the speed of the pressure sweep. Indicated in daPa per second.

Note ·

It is highly recommended that the lowest setting (50 daPa/s) is always used for ETF-P.

Otometrics

189

Immittance Module Tools Options (view and measurement options)

Measurement settings

Pump speed (daPa/s)

While the pump is operating, a scale at the top of the screen indicates the current pump position graphically, i.e. the proportion of the pump’s capacity being used to obtain the static pressure used for the measurement.

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Otometrics

14 OTOflex 100 Service and Maintenance

14.1

Equipment failure

Warning ·

Do not use a defective instrument.

If you believe the correct function or operation safety of OTOflex 100 to be faulty in any way, disconnect OTOflex 100 from the power supply, remove the batteries, and make sure that it cannot be used by others until it has been serviced.

Warning ·

Under no circumstances disassemble OTOflex 100. Contact your supplier.

14.2

Service and repair

Under no circumstances disassemble OTOflex 100. Contact your supplier. Parts inside OTOflex 100 must only be checked or serviced by authorized personnel.

Warning ·

Do not disassemble OTOflex 100 charger, as there is a risk of electric shock.

For the sake of safety and in order not to void the warranty, service and repair of electromedical equipment should be carried out only by the equipment manufacturer or by service personnel at authorised workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.

Following repair, the equipment should be tested by suitably qualified personnel.

On request, your supplier can obtain a Service Manual from the manufacturer. The

Service Manual contains electrical diagrams, descriptions, lists of components and calibration information, etc.

14.3

Maintenance

OTOflex 100 requires no preventive maintenance. However, it is recommended that you observe the guidelines below.

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OTOflex 100 Service and Maintenance

Maintenance

14.3.1

Calibration

OTOflex 100 and the probes are delivered fully calibrated.

• The device is calibrated from the factory in dB SPL or dB HL using the stated reference equivalent thresholds. dB HL are related to sound pressure levels, dB

SPL = dB re 20 PA.

• The probe calibration values are saved in the probe assembly and follows the probe. The probe can be plugged to any OTOflex 100 and used right away. This also applies to the contra insert phone.

Calibration frequency

The OTOflex 100 device and probes must be calibrated once a year by your authorized service department.

14.3.2

Probe cleaning and maintenance

Note ·

Never immerse OTOflex 100 probe into water or other cleaning solutions.

The probe body

Caution ·

For periodical cleaning of the probe body, contact your authorized service department.

The probe tip

Note ·

Never place the probe tip in the ear canal without using a clean eartip.

The probe tip usually does not come into contact with the skin or secretion from the ear canal, as it is covered by the eartip. However, in some cases large amounts of cerumen in the ear canal may result in debris being deposited on the probe tip. If this is the case, clean the probe tip sound channels with the cleaning wire.

Note ·

Check the channels in the probe tip every time you have used the probe. Even small amounts of cerumen or vernix can block the probe channels. Clean the channels if required.

Note ·

Wipe the plastic probe tip with a disinfectant (for example ethanol) between patients or replace it with a spare one.

• If you have replaced the probe tip and/or the acoustic filter, do a probe test.

NEVER

insert the probe tip into the test cavity of OTOflex 100 without first cleaning and disinfecting the probe tip. See

6.3.3 Probe check  57 .

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Otometrics

14.4

OTOflex 100 Service and Maintenance

Cleaning and disinfecting the probe tip

Cleaning and disinfecting the probe tip

Note ·

Always comply with local hygienic standards for disinfection and sterilization.

Thorough cleaning of the probe tip is required after use in infected ear canals. Cleaning the threaded ring may also be necessary.

1. To remove the probe tip, hold the probe by the probe body and unscrew the threaded ring. Take out the probe tip.

Probe body Threaded ring

Threaded ring

Probe tip

Probe tip

2. Check to see if the sound channels of the probe tip are blocked. If they are, use the cleaning wire to clean the sound channels.

Alw ays clean from the rear.

Sound channels Cleaning wire

3. If you are cleaning the probe tip during a session where you are testing a patient, use the cleaning brush to clean the cleaning wire, especially where it protrudes from the probe tip.

If you are cleaning the probe tip between patients, use disinfectant to clean the cleaning wire, and, if you have used the brush, disinfect the brush as well. See

14.4.0.1 Cleaning and disinfecting procedures for the probe tip  194 .

Cleaning wire

Otometrics

Caution ·

Even the slightest amount of moisture may dissolve any residual cerumen and thus contaminate the sensitive parts in the body of the probe.

193

OTOflex 100 Service and Maintenance

Cleaning and disinfecting the probe tip

4. Make sure that the sound channels are completely dry before you fit the tip back onto the probe body (tighten well), or use a spare probe tip.

Caution ·

The probe body contains sensitive components. Never clean the sound channels in the probe body mechanically or with liquids. Doing so may cause damage to the probe.

5. Fit the probe tip and screw the threaded ring firmly back onto the probe body.

Tighten well to prevent leakage.

14.4.0.1

Cleaning and disinfecting procedures for the probe tip

The probe tip material is highly resistant to a wide range of temperature and chemical influences.

Regular cleaning

• Use a wet tissue for regular surface cleaning.

• Use ultrasonic cleaning to remove contaminants, for instance before autoclaving.

Disinfecting

You can choose between a number of methods for disinfecting the probe tip, for instance:

• Immersion of the probe tip in a bath of 70-90% ethyl or isopropyl alcohol for

10-30 minutes contact time.

• Immersion of the probe tip in a Sodium Hypochlorite solution at high concentrations and extended contact time (considered a cold sterilant).

When you have cleaned the probe tip, rinse it thoroughly in regular water.

Autoclaving

Use autoclaving in accordance with the national standards for vapour cleaning with an exposure time of up to 45 minutes at a maximum temperature of 150°C.

The probe tip is designed to withstand up to 3,000 autoclaving cycles in which temperatures typically reach 134°C.

Make sure that the probe tip has not been deformed by the autoclaving process.

Cleaning and disinfecting the test cavity

Caution ·

The test cavity is located in the charger, which contains electrical components and electrical power connection. Therefore:

do not

use bath or autoclaving!

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OTOflex 100 Service and Maintenance

Cleaning OTOflex 100

If the test cavity has been contaminated with debris from the probe tip, use gas cleaning according to local hygienic standards (i.e. with ethyleneoxide, at a temperature of

55°C, at a pressure of 0.8 to 1.0 bar).

14.4.1

Changing the wax filter

If you are warned that there is a probe error, or that the probe is not OK, check whether the probe tip is blocked. If it is not, the wax filter of the probe may be damaged or blocked by cerumen.

If this is the case, change the wax filter.

Note ·

Never immerse the OTOflex 100 probe into water or other cleaning solutions.

1. To replace the wax filter, remove the probe tip. See 14.4 Cleaning and disinfecting the probe tip  193

.

2. Use the extraction lever to take out the wax filter from the probe tip.

Wax filter

Extraction lever

Note ·

Filters are disposables. See 14.5.2 Disposal of disposable articles

196 for

instructions on disposal.

Do not put used filters in the accessory box.

3. Insert a new filter. Be careful not to damage the filter openings.

4. Fit the probe tip over the acoustic filter in the probe body and and screw the threaded ring back onto the probe body. Tighten well.

14.5

Cleaning OTOflex 100

Prerequisites

• Before cleaning, switch off OTOflex 100 and disconnect it from any external power source.

• Dismount the probe from OTOflex 100.

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OTOflex 100 Service and Maintenance

Cleaning OTOflex 100

Regular cleaning

• Clean OTOflex 100 with a damp cloth - if required, use a surface disinfectant.

Note ·

Never use liquids.

Note ·

Always make sure that no moisture enters the probe or the sockets (charger insert and probe sockets).

Note ·

Never immerse OTOflex 100 into water or other cleaning solutions.

Clean the screen periodically. Use an anti-static non-solvent solution on a lint-free cloth. Use a soft brush to remove dust. Use a small amount of mild detergent on a damp cloth to clean the cabinet and front.

14.5.1

Eartips

Eartips are in direct contact with your patients, and you should therefore observe strict hygienic precautions to prevent passing infections from one patient to another.

• Use only disposable ear tips.

• Dispose of eartips after use.

Disposal

OTOflex 100 eartips and foam eartips for the E-A-RTONE® 3A insert phone are disposable, and should not be cleaned or re-used. Always throw away disposable eartips

after use on a patient. See 14.5.2 Disposal of disposable articles  196

for instructions on disposal.

14.5.2

Disposal of disposable articles

Disposable articles (such as eartips and cleaning wires) should be disposed of according to local regulations.

14.5.3

Batteries and charger

Note ·

For disposal of old batteries, see 14.5.5 Environmental protection

198 .

1. To change batteries press the cover inwards and upwards until it is released and snaps out of place.

196

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OTOflex 100 Service and Maintenance

Cleaning OTOflex 100

2. Insert the batteries as shown below. If you are in doubt, look inside the battery casing where you will see small red plus signs indicating which way the batteries fit.

+

+

+

+

3. To put the battery cover back in place, insert the cover with the curved edge facing upwards in the opening. Press the cover inwards and downwards until it clicks into place.

Battery cover

14.5.4

Safety information

Explosion hazard

• Do not throw the batteries into the fire and keep them away from fire as they may explode.

• Incorrect handling, applying excessive charging current can overcharge or destroy the batteries.

• The battery terminals must under no circumstances be short-circuited.

• Do not open, alter or dismantle the charger.

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197

OTOflex 100 Service and Maintenance

Cleaning OTOflex 100

14.5.5

Environmental protection

• OTOflex 100 can be disposed of as normal electronic waste, according to local regulations.

• Dispose of batteries according to local regulations.

198

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15 Installing MADSEN OTOflex 100

15.1

Unpacking OTOflex 100

1. Unpack OTOflex 100 carefully.

When you unpack OTOflex 100, it is a good idea to keep the packing material in which it was delivered. If you need to send OTOflex 100 in for service, the original packing material will protect against damage during transport, etc.

2. Inspect the equipment for possible visual damage.

If damage has occurred, do not put OTOflex 100 into operation. Contact your supplier for assistance.

3. Check with the list accompanying the package to make sure that you have received all necessary parts and accessories. If your package is incomplete, contact your supplier.

15.2

Storing OTOflex 100

If you need to store OTOflex 100 before you put it into operation, follow the guidelines below:

• Store OTOflex 100 and accessories in the box provided to protect the equipment from damage.

• Store OTOflex 100 as stated in

App. 6.4 Storing and handling  258

.

15.3

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Views of OTOflex 100

This section provides you with views of OTOflex 100 and its charger from various angles, as well as instructions on how to assemble the charger.

15.3.1 Front view  200

15.3.2 Top view  200

15.3.3 Bottom view  201

15.3.4 Reverse side view  201

15.3.5 The charger  201

15.5.2 Desktop installation  203

You will find a description of the keypad and how to navigate and enter data in

OTOflex 100 in 3.2 Controls and menu selections  25

.

199

Installing MADSEN OTOflex 100

Views of OTOflex 100

15.3.1

Front view

Probe

200

15.3.2

Top view

Contralateral socket

Probe plug

Screen

Keypad

Device colour code

Loudspeaker (optional)

Pneumatic connection

Probe socket

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15.3.3

Bottom view

Battery casing with cover

15.3.4

Reverse side view

Track for probe cable

Installing MADSEN OTOflex 100

Views of OTOflex 100

Charger cavity

Labels

15.3.5

The charger

Front view

Charger tab for charging the device

Charging indicator

Probe test cavity

Base

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201

Installing MADSEN OTOflex 100

The probe

Rear view

Power socket

15.4

The probe

Probe body

Threaded ring

Probe tip

Probe

Probe plug

Air connector

Transducer connector

15.5

Assembly and installation

15.5.1

Location

Immittance testing is facilitated by a moderately quiet room. A sound cabin or sound treated room is not necessary.

202

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Installing MADSEN OTOflex 100

Assembly and installation

To ensure safe performance, you must make sure that OTOflex 100 is correctly

installed and that the requirements listed in App. 1 Standards and safety -

OTOflex 100 and the Immittance Module  215

are complied with.

OTOflex 100 can be used as a hand-held device with no specific requirements to location. However, keep OTOflex 100 away from all liquids and sources of heat (for

detailed specifications, see App. 6.3 Operating environment  258

.

15.5.2

Desktop installation

If you are using the desktop charger, mount the charger on the charger base as shown below.

1. Use the hexagonal key to screw the hexagonal screws into place.

Charger body

Base

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Hexagonal screws

Hexagonal key

2. Make sure that you tighten the screws well so that the charger is stable when you place OTOflex 100 in the charger.

203

Installing MADSEN OTOflex 100

Assembly and installation

Base

15.5.3

Wall mount installation

Hexagonal key

130mm (

5.12”)

2 rawl plugs

2 washers

2 screws wafcrsher wallmount backplate plastic shelf

204

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Otometrics

Installing MADSEN OTOflex 100

Assembly and installation

1. Drill 2 x 6 mm diameter holes 130 mm (5.12") apart.

2. Insert rawl plugs.

3. Insert the screws with the washers mounted, through the backplates of the wallmount.

1 2

3

205

Installing MADSEN OTOflex 100

Powering

15.6

Powering

15.6.1

Powering OTOflex 100

Device

• OTOflex 100 device is powered by batteries.

See

15.6.2 Batteries  206

.

Charger

• The OTOflex 100 charger is connected to the electrical power outlet.

It is recommended that you leave OTOflex 100 in the charger when not in use. This ensures that the device is always ready for testing.

See the following descriptions for powering.

Power-related settings

You can customize the various power-related settings in OTOflex 100 to suit your

purposes and save power/batteries. See 12.2.4 Device settings  145

.

15.6.2

Batteries

Note ·

Do not insert the battery cover in OTOflex 100 before you have inserted batteries.

If you do, the cover will lock in place inside the device.

Caution ·

Use only the battery types listed in

App. 6 Technical Specifications - MAD-

SEN OTOflex 100

255 .

OTOflex 100 attempts to check the battery type when you switch it on or place it in the charger, and will prompt you for the battery type if it seems to be wrongly configured.

• NiHM rechargeable batteries

OTOflex 100 is delivered with rechargeable NiHM batteries. Before you can operate OTOflex 100, insert the batteries in OTOflex 100 and leave it to charge in the OTOflex 100 charger for at least 14 hours, and preferably overnight, before switching on OTOflex 100.

Rechargeable batteries will reach full capacity when they have been recharged a couple of times.

• Alkaline batteries

If required, OTOflex 100 can be powered by non-chargeable Alkaline batteries.

Warning ·

When using OTOflex 100 with Alkaline batteries, always switch off the power supply to the charger. Failure to do so may cause the Alkaline batteries to leak and cause damage to OTOflex 100.

206

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Installing MADSEN OTOflex 100

Powering

To protect the Alkaline batteries from charging, and to make sure that the

OTOflex 100 battery indicator displays the correct status when Alkaline batteries are used, change the battery type setting in OTOflex 100 to reflect the type you have inserted:

• Select

Menu > Advanced > Device Settings > Battery type

and press

Select

to toggle to

Alka

.

When you are using Alkaline batteries the battery icon in the top right corner of the screen will remain, even if you place OTOflex 100 in the charger.

15.6.2.1

Inserting batteries

1. The batteries and the battery cover are delivered in a small bag.

Warning ·

Do not put the battery cover in place without first inserting the batteries!

2. Insert the batteries as shown below. If you are in doubt, look inside the battery casing where you will see small red plus signs indicating which way the batteries fit.

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+

+

+

+

3. To put the battery cover back in place, insert the cover with the curved edge facing upwards in the opening. Press the cover inwards and downwards until it clicks into place.

207

Installing MADSEN OTOflex 100

Powering

Battery cover

4. The next time you change batteries, press the cover inwards and upwards until it is released and snaps out of place.

208

5. Check the battery type setting in OTOflex 100: See 15.6.2.2 Battery type setting  208 .

6. If you are using rechargeable batteries, leave OTOflex 100 to charge for at least

14 hours, and preferably overnight, before you put it into use (see 15.6.3 The charger  209

for details).

15.6.2.2

Battery type setting

OTOflex 100 is delivered preset for NiHM rechargeable batteries.

1. If you are in doubt of the setting, or if you are using Alkaline batteries, check the battery type and the setting in OTOflex 100: When OTOflex 100 is ready for use, switch it on: Press and hold the

On/Off

key on the keypad.

2. Press

Select

to access the

Menu

followed by

Advanced.. > Device Settings..

3. Scroll to

Battery type

.

4. To change the setting, press

Select

to toggle to the correct battery type. You can choose between NiHM (rechargeable) or Alka(line).

Caution ·

If you are using Alkaline batteries and place OTOflex 100 in the charger, make sure that you set the battery type to Alka(line). This will prevent OTOflex 100 from trying to charge the non-chargeable Alkaline batteries.

Warning ·

When using OTOflex 100 with Alkaline batteries, always switch off the power supply to the charger. Failure to do so may cause the Alkaline batteries to leak and cause damage to OTOflex 100.

5. Press the left softkey to exit.

6. If required, press and hold the

On/Off

key on the keypad to switch off

OTOflex 100.

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Installing MADSEN OTOflex 100

Powering

15.6.2.3

Powering status

OTOflex 100 powered by batteries only:

When OTOflex 100 is powered by batteries only, i.e. when it is not placed in the charger or Alkaline batteries are used, it shows the approximate remaining capacity of the batteries in the top right corner of the screen.

OTOflex 100 powered by charger:

When OTOflex 100 is charging, a small power plug icon is shown in the top right corner of the screen.

15.6.3

The charger

15.6.3.1

Powering the charger

Caution ·

Operating at the wrong voltage may blow the fuses! See the label on the charger for input voltage.

Before you connect the power cable to the charger, make sure that the voltage from the electrical power outlet matches the voltage shown on the identification label on the charger.

1. Plug the end (A) of the supplied power cable into the power inlet on the charger

(see below).

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A

2. Connect the power cable of the OTOflex 100 charger to a power outlet.

209

Installing MADSEN OTOflex 100

Powering

15.6.3.2

First time charging

Charging applies only if you use rechargeable batteries.

• Leave OTOflex 100 to charge for at least 14 hours before you put it into use.

15.6.3.3

Charger status

When OTOflex 100 is placed in the charger, you can follow the status of the charging process on the charging indicator on the charger front.

When charging, the diode indicates the following:

• Green, steady:

OTOflex 100 is not charging.

Note that charging is resumed when the device is reinserted into the charger or the device is turned on.

• Amber, steady:

OTOflex 100 is charging.

Note that charging is automatically discontinued based on a timer. This is done to ensure that batteries are not over-charged.

• Amber, flashing:

There is a fault in the charger. Contact your supplier.

15.6.4

Switching on OTOflex 100

To switch on OTOflex 100 press and hold the

On/Off

key on the keypad until the splash screen appears (approximately 2-3 seconds).

210

15.6.5

Bluetooth

Communication via Bluetooth is set to

On

as default.

To enable/disable Bluetooth communication:

1. Switch on OTOflex 100.

Otometrics

Installing MADSEN OTOflex 100

Powering

2. Press

Select

to access the

Menu

followed by

Advanced.. > Device Settings..

3. Scroll to

Bluetooth

and press

Select

to toggle to

On/Off

.

4. Press the left softkey to exit.

Communication via Bluetooth has now been enabled/disabled.

Note ·

OTOflex 100 must be switched on to be able to communicate with OTOsuite.

For further information on communicating with OTOsuite, please see the OTOsuite

User Manual.

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211

Installing MADSEN OTOflex 100

Powering

212

Otometrics

16 Configuring OTOsuite

The Configuration Wizard guides you through the process of customizing the various features and functions that apply to OTOsuite.

1. Select

Tools > Configuration wizard..

and click on Configure.. next to Immittance.

Synchronizing

Resolve Synchronization Conflicts.

1. Click the specific button defining the action you wish, when you need to synchronize OTOflex and

OTOsuite data.

2. Click

Next

to continue or

Close

to exit Immittance configuration.

OTOflex

Connect to the device you wish to use for testing.

1. Click on the device you wish to use.

– If the device is not listed, check the checkbox

My device is turned on and ready to be found

, and click on

Search

.

– Select the device and click

Next

or

Close

.

2. If connection to the device has been interrupted, click on

Repair

.

OTOflex Firmware Upgrade

Upgrade the device firmware.

Upgrades the firmware of your device.

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213

Configuring OTOsuite

214

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App. 1 Standards and safety - OTOflex 100 and

the Immittance Module

This documentation contains information and warnings, which must be followed to ensure the safe use of OTOflex 100 and the Audiometry Module. Local government rules and regulations, if applicable, should also be followed at all times.

App. 1.1

Symbols used

App. 1.1.1

OTOflex 100 symbols

x x x x

OTOflex 100 is marked with this symbol to indicate compliance with

Type BF of the safety standard EN 60601-1. See Technical Specifications, Standards in the OTOflex 100 Guide.

OTOflex 100 is marked with this symbol when it is important that the user refers to associated information given in this manual.

OTOflex 100 is CE-marked according to the Medical Devices Directive 93/42/EEC and the Radio Equipment and Telecommunications

Terminal Equipment Directive 1999/5/EC.

The instrument is marked with this symbol to indicate that it is electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment (WEEE).

In European countries the crossed-out wheeled-bin WEEE symbol reminds you that all the electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies in the European Union.

Do not dispose of these products as unsorted municipal waste.

You can return your instrument and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal.

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215

App. 1 Standards and safety - OTOflex 100 and the Immittance Module

Symbols used

Classified with respect to electrical shock, fire, mechanical and other specified hazards only in accordance with UL2601-1 and CAN/CSA-

C22.2 NO 601.1-90

OTOflex 100 carries this symbol to indicate that, in France, it is only permitted to use the device indoors.

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that may cause undesired operation.

Refer to Notes 5 through 7 in App. 1.2 Warning notes  217

for more details.

The term”IC”: before the certification/registration number only signifies that the Industry Canada technical specifications were met.

Interference may occur in the vicinity of OTOflex 100. Local regulations and precautions for other equipment in the environment should always be followed to avoid interference.

The separation distance from OTOflex 100 to other devices complying with standard immunity requirements in EN 60601-1-2 is minimum 0.35 m/1ft.

For use in restricted areas the OTOflex 100 features the ability to turn off the built-in Bluetooth module, i.e. disabling the Bluetooth radio communication. OTOflex 100 has built-in storage capabilities to store data measured offline and these data can later be transferred in other locations.

Symbols on buttons to operate OTOflex 100, see

3.2 Controls and menu selections  25 and

7 Testing with MADSEN

OTOflex 100  67

.

App. 1.1.2

Charger unit symbols

The charger unit is marked with this symbol to indicate compliance with Class II requirements of the safety standard EN 60601-1.

The charger unit is marked with this symbol when it is important that the user refers to associated information given in this manual.

216

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App. 1 Standards and safety - OTOflex 100 and the Immittance Module

Warning notes

x x x x

The charger unit is CE-marked according to the Medical Devices

Directive 93/42/EEC.

The charger unit is marked with this symbol to indicate it is a UL recognized component for Canada and the United States.

The charger unit is marked with this symbol to indicate that it is suitable for alternating current only.

App. 1.1.3

The OTOsuite Audiometry Module

x x x x

The Audiometry Module and this documentation are CE-marked according to the Medical Devices Directive 93/42/EEC.

Used in error messages if program fails. See the detailed information in the dialog box.

App. 1.2

Warning notes

App. 1.2.1

OTOflex 100 warning notes

OTOflex 100 should only be provided with prescribed battery types, see Technical Specifications in the OTOflex 100 Guide.

Place the batteries as indicated in the battery compartment, see

15.6.2 Batteries  206

for further details.

Use only rechargeable batteries when OTOflex 100 is placed in the charger unit. If you are using alkaline batteries, do not attempt to charge your OTOflex 100. Your alkaline batteries may be damaged and leak, and this may in turn cause damage to OTOflex 100.

Batteries should be removed if equipment is not likely to be used for some time.

OTOflex 100 should only be connected to charger type 1012 Charger from GN Otometrics A/S.

Note 1:

There are no user-serviceable parts inside the OTOflex 100 cabinet. For the sake of safety, and in order not to void the warranty, the cabinets should only be opened and serviced by authorized service personnel. In case of defects, please

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217

App. 1 Standards and safety - OTOflex 100 and the Immittance Module

Warning notes

make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument.

Note 2:

Keep OTOflex 100 away from liquids. Do not allow moisture inside the instrument.

Note 3:

Do not use the instrument in the presence of flammable anesthetics (gases).

Note 4:

Unwanted noise may occur if OTOflex 100 is exposed to a strong radio field.

Such noise may interfere with the process of recording correct measurements.

Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of

OTOflex 100 is restricted as much as possible.

Note 5:

Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

Note 6:

This equipment has been tested and found to comply with the limits for a Class

B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

– Reorient or relocate the receiving antenna.

– Increase the separation between the equipment and receiver.

– Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

– Consult the dealer or an experienced radio/TV technician for help.

Note 7:

For use in Canada: To prevent radio interference to the licensed service, this device is intended to be operated indoors and away from windows to provide maximum shielding. Equipment (or its transmit antenna) that is installed outdoors is subject to licensing.

Note 8:

No parts may be eaten, burnt, or in any way used for purposes other than audiometry or the fitting of hearing aids.

Note 9:

OTOflex 100 can be disposed of as normal electronic waste, according to local regulations. Please investigate local regulations concerning the disposal of rechargeable and alkaline batteries.

218

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App. 1 Standards and safety - OTOflex 100 and the Immittance Module

Manufacturer

Note 10:

For safety reasons, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.

Note 11:

It is recommended that an annual calibration be performed on accessories containing transducers. Furthermore, it is recommended that calibration be performed if the equipment has suffered any potential damage (e.g. transducers dropped on the floor). Note that calibration has been performed only on the transducers supplied! If you wish to use any other transducer for testing with

OTOflex 100, please contact your local supplier.

Note 12:

To comply with EN 60601-1-1 computer and printer must be placed out of reach of the patient, i.e. not closer than approx. 1.5 meters/5 ft.

App. 1.2.2

Charger unit warning notes

In order to disconnect the charger unit from the electrical power supply the power cable must be detached from the power source.

Note 1:

There are no user-serviceable parts inside the charger unit cabinet. For the sake of safety, and in order not to void the warranty, the cabinets should only be opened and serviced by authorized service personnel. In case of defects, please make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument.

Note 2:

The charger unit can be disposed of as normal electronic waste, according to local regulations.

App. 1.3

Manufacturer

GN Otometrics A/S

2 Dybendalsvaenget

DK-2630 Taastrup Denmark

T

: +45 45 75 55 55,

F

: +45 45 75 55 59 www.otometrics.com

App. 1.3.1

Responsibility of the manufacturer

The manufacturer is to be considered responsible for the effects on safety, reliability, and performance of the equipment ONLY IF:

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219

App. 1 Standards and safety - OTOflex 100 and the Immittance Module

Manufacturer

• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by personnel authorised by the manufacturer.

• The electrical installation to which the equipment is connected is grounded and complies with IEC requirements.

• And the equipment is used in accordance with the instructions for use.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.

220

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App. 2 MADSEN OTOflex 100 Immittance

Methodology and Features

App. 2.1

An introduction to immittance

Immittance measurements are used to determine the middle ear's ability to transfer sound waves to the inner ear, as well as assess the impact of middle ear mechanisms that alters this ability.

The purpose of the middle ear is to enhance the incoming soundwave in order to overcome the higher impedance of the inner ear fluids, thus allowing the air-borne sound wave to be transferred into a liquid wave without being deflected.

The main mechanism used to achieve the sound wave transformation is the difference in the surface area of the tympanic membrane and the stapes footplate.

Also, the middle ear includes the three middle ear bones or ossicles, malleus, incus and stapes, whose lever action adds to the sound pressure at the oval window. Any alteration to the middle ear system, such as fluid or air pressure build-up in the middle ear cavity or inhibition of the ossicular chain movements, will result in an inefficient transfer of acoustic energy through the middle ear. This results in sound waves being reflected back through the outer ear.

App. 2.1.1

Immittance testing

Immittance testing as used in OTOflex 100 is characterised by the following:

A probe tone is delivered through the transducers of the probe into the ear. The microphone of the probe then measures the acoustic energy that remains in the ear canal. As the ear canal air pressure or middle ear muscle activity alters the mobility of the middle ear system, different amounts of remaining acoustic energy can be measured at the probe, depending on the amount of air pressure or muscle activity applied.

The maximum acoustic energy admittance (the point at which the most acoustic energy enters the middle ear) is obtained when the middle ear mobility is maximised.

This occurs when the ear canal air pressure is equal on both sides of the eardrum membrane, and the middle ear muscles are in a neutral state.

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221

App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Tympanometry

When using a 226 Hz probe tone, the acoustic admittance of air enclosed in a 1 cc cavity is 1 mmho. Therefore, in 226 Hz immittance measurements, the admittance unit mmho is interchangeable with the volume units cubic centimetres (cc or cm

3

) or millilitres (ml) as a measure of the acoustic compliance. This 1:1 admittance versus volume equivalence is only applicable for the 226 Hz probe tone. Further, because the middle ear admittance is primarily determined by stiffness (compliant susceptance) in this frequency region, the middle ear compliance can only be considered isolated using low frequency probe tones.

[1]

In OTOflex 100, you can choose between any of the compliance or admittance units

cc, cm3, or mmho respectively, when you use a 226 Hz probe tone. When you use a higher frequency probe tone, all admittance components are measured and the unit is accordingly always mmho.

For reflex testing with OTOflex 100, the volume unit l can also be chosen for

226 Hz measurements. When l is used, the corresponding numerical values are multiplied by factor 1000.

App. 2.2

Tympanometry

In tympanometry you can measure the acoustic admittance of the middle ear system as a function of ear canal air pressure. The resulting tympanogram is predominantly determined by the ear cavity volumes, the mobility of the eardrum and the ossicular chain, and the middle ear air pressure. Admittance values are shown on the vertical axis of the tympanogram, and the ear canal air pressure is shown on the horizontal axis.

Tympanometry is used to indicate or, in conjunction with other audiological tests, confirm disorders such as ossicular discontinuity, otosclerosis, flaccid (hypermobile) eardrum, eardrum perforation, obstruction of the ear canal, middle ear effusion, or

Eustachian tube malfunctions.

The tympanometry tests are controlled by a number of default settings, which you can either leave as they are, or customize to your requirements.

App. 2.2.1

Tympanometry testing on infants

It is strongly recommended that the 1000 Hz probe tone is used for infant tympanometry up to 4 - 6 months of age. The 1000 Hz probe tone is recommended for a

222

[1] For a comprehensive understanding of immittance vector principles, see e.g. Margolis & Hunter (2000), Acoustic Immittance Measurements. In: R.J. Roeser, M. Valente & H. Hosford-Dunn(Eds.) Audiology Diagnosis, or

T.L. Wiley & D.T. Stoppenbach (2002), Basic Principles of Acoustic Immittance Measures. In: J. Katz (Ed.)

Handbook of Clinical Audiology, Fifth Edition.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Tympanometry

number of reasons; one of them is to avoid the very low resonance frequency that is characteristic for infant ears.

A number of developmental aspects through the first few months of life are believed to significantly alter the acoustic response properties of the infant's middle ear, thus also influencing tympanometry, e.g.

• size increase of the external ear, middle ear cavity and mastoid

• a change in the orientation of the tympanic membrane

• fusion of the tympanic ring

• a decrease in the overall mass of the middle ear due to changes in bone density

• loss of mesenchyme (connective tissue of the embryo)

• tightening of the ossicular joints

• closer coupling of the stapes to the annular ligament

• the formation of the bony ear canal wall

The infant ear anatomy differs in many ways when compared with the adult ear.

Because of these differences, a higher frequency probe tone is needed to collect tympanograms that will be useful in identifying middle ear effusion. Infants below 4 months may demonstrate what appears to be a normal 226 Hz tympanogram even with confirmed middle ear effusion. It is also possible to obtain what appears to be abnormal 226 Hz tympanograms in normal ears. The 1000 Hz probe tone has proven to be the best choice for immittance measurements in infants. See also Probe

frequency in 12.3 Tympanometry setup  148 .

App. 2.2.2

Tympanometric features

Tympanometric Peak Pressure, TPP

Tympanometric Peak Pressure, TPP, denotes the air pressure value on the horisontal axis, where the admittance peak is registered. This value may be taken to approximate the current middle ear pressure.

Static Admittance, SA

Static Admittance, SA, is a measure of the middle ear admittance calculated as the difference between the admittance at the peak of the tympanogram (including both the middle ear and ear canal components) and the baseline admittance measured at

200 daPa (approximates the isolated ear canal component). In accordance with this, static admittance is often referred to as the "peak to tail difference".

The SA is shown only when the baseline compensation is enabled, i.e. when the admittance is shown relative to the baseline admittance.

When a 226 Hz tympanogram is shown in volume units, the term Static Compliance, SC, is used instead of SA.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Tympanometry

Note ·

Static Admittance, SA, is the same as the ANSI S3.39-1987 peak compensated static acoustic admittance, Peak Ytm.

Tympanometric Width, TW

Tympanometric Width, TW, provides a measure of the sharpness, or steepness, of the tympanogram. TW is the curve width at half the height of the curve (SA/2). TW is measured in daPa in accordance with the illustration below.

Tympanometric Width

Tympanometric Width

Admittance

(mmho) SA

SA/2

Pressure

(daPa)

TW

Equivalent Ear Canal Volume, ECV

Equivalent Ear Canal Volume, ECV, is measured as the compliance at +200 daPa ear canal pressure. Accordingly, the ECV is only shown when a 226 Hz probe tone is used.

When using a higher frequency probe tone, the Equivalent Baseline Volume, EBV, is shown instead of ECV.

Measurement-plane tympanogram

Baseline compensation: OFF

224

SA

ECV

Total Admittance

TPP

Tympanometry type, “Type”

Tympanometry type, “Type”, is a classification method of the shape of the 226 Hz tympanogram. This is the modified Jerger classification system.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Tympanometry

The classification is carried out in relation to a normative range shown as a rectangle in the tympanometry graph.

Note ·

This classification system does not take the tympanometric width or gradient into account.

• Type A is a normal tympanogram with a single SA peak within the rectangle.

• Type Ad is a high admittance tympanogram reaching above the rectangle.

• Type As is a low admittance tympanogram with the peak below the rectangle.

• Type B is a flat tympanogram with no discernible peak.

• Type C is a tympanogram with the SA peak appearing to the left of the rectangle, thus showing a negative TPP (more negative than -100 daPa).

• In addition, Type D may be used to indicate a multiple peaked tympanogram.

Adult 226 Hz tymp classification system

OTOflex 100 uses the Adult 226 Hz norm originating partly from Jerger. The determination of types A, Ad, As, B, and C is based on the location (pressure and static admittance) of the peak of the tympanogram as shown below:

1.7

0.3

Ad Ad Ad

C

A

C

B/ B/ B/

-100 +50 daPa

• B is used instead of As for curves with no significant peak.

• Pressure limits: -100 to +50 daPa.

• Static admittance limits: 0.3 to 1.7 mmho.

App. 2.2.3

ETF-I (Eustachian Tube Function - Intact)

ETF-I is done to examine how well the middle ear is ventilated through the Eustachian tube. Air must be able to pass through the Eustachian tube in order to equalise the middle ear pressure.

For testing the tube function in ears with intact eardrums (ETF-I), multiple tympanograms are recorded with different middle ear pressure equalisation maneuvers done between the measurements. The tympanogram tympanometric peak pressures are compared to evaluate whether pressure equalisation is successful.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Acoustic Reflex testing

In general, people have a slight negative middle ear pressure (quite normal even with a fully functioning Eustachian tube). A successful equalisation of negative pressure will displace the tympanometric peak in a positive direction in the tympanogram. It is less common with standing positive pressure in the middle ear, due to the anatomical properties of the Eustachian tube. The tube is likely to be forced open by the pressurised air itself. Equalisation of positive pressure will displace the tympanometric peak in a negative direction in the tympanogram.

Typical special equalisation techniques used are the Valsalva and Toynbee maneuvers.

App. 2.2.4

Valsalva’s Maneuver

This maneuver equalises the pressure (or induces positive pressure) in the middle ear by forcing air through the tuba into the middle ear cavity. This is a common procedure used for pressure equalisation when diving or flying. In some ears, this maneuver can also induce a standing positive pressure. However, as mentioned above, this is usually difficult to maintain without the air spontaneously leaking out back through the tuba. The resulting tymp peak after this maneuver will often appear around 0 daPa, ± approx. 15 daPa.

How to perform the maneuver

• Instruct the patient to block the nostrils by pinching the nose using the thumb and index finger.

• Instruct the patient to carefully blow some air out of the mouth but with the lips tightly sealed.

App. 2.2.5

Toynbee’s Maneuver

This maneuver primarily creates a negative middle ear pressure since air will be evacuated from the middle ear through a functioning tuba.

How to perform the maneuver

• Instruct the patient to block the nostrils by pinching the nose using the thumb and index finger.

• Instruct the patient to swallow a few times. It may help to provide some water to drink.

App. 2.3

Acoustic Reflex testing

The term “Acoustic Reflex” refers to the stapedius reflex, a middle ear muscle contraction which is normally elicited binaurally by particularly loud sounds. The acoustic reflex is assessed through the measuring of an acoustic admittance change as the ear is stimulated with different loud pure tones or with filtered noise. As the stapedius muscle contracts, tension in the ossicular chain stiffens the middle ear, and conse-

226

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Acoustic Reflex testing

quently compromises the acoustic energy flow through the middle ear. The probe microphone detects this change as the acoustic energy remaining in the ear canal is increased. The resulting graph shows the admittance change on the vertical axis and time on the horizontal axis. The properties of the reflex are determined from a curve deflection referenced to an initial baseline. The baseline is the total ear admittance without any stimulus applied.

It is important to note that the change in admittance, which results from the functioning of the reflex mechanism, is very small. It is further diminished if the eardrum is tensioned by a static pressure differential between the ear canal and the middle ear.

Therefore, measurements are made with an ear canal air pressure applied, corresponding to the tympanometric peak pressure.

See

Tympanometric Peak Pressure, TPP  223

.

Always perform tympanometry before attempting to assess the acoustic reflex. Atmospheric pressure (0 daPa) is used in case no tympanometric peak data is available. The tympanometric peak data is probe tone specific. In case of baseline instability due to a hyperflaccid eardrum, a pressure offset of 20-30 daPa in the same direction as TPP displacement may be used. A pressure offset of this magnitude will stabilise the flaccid eardrum without obscuring the reflex induced admittance change.

Due to the physiology of the neural pathways involved, acoustic reflexes can be elicited either with stimulation of the ipsilateral (probe ear) or contralateral ear. This means that the acoustic reflex is a binaural phenomenon. This is used for diagnostic purposes since different configurations of reflex integrity, when comparing ipsi and contralateral measurements, suggest different sites and types of lesions.

Acoustic reflex tests are used to indicate, or, in conjunction with other audiological tests, confirm disorders such as retrocochlear pathology, brainstem lesions, Bell’s palsy, conductive hearing loss, cochlear hearing loss, etc.

Many different features of the acoustic reflex may be studied. Clinically, the most

common are the Acoustic Reflex Threshold (see App. 2.3.2 Acoustic Reflex

Threshold  228 ) and the Acoustic Reflex Decay ( App. 2.3.3 Acoustic reflex decay  228 ).

App. 2.3.1

Acoustic Reflex Screening

Acoustic Reflex Screening is not a threshold search, but provides useful information about presence/absence of acoustic reflexes within normal stimulus levels.

Normal hearing individuals or individuals with symmetrical sensorineural hearing loss, where there is no suspicion of retrocochlear pathology may be tested with a condensed screening protocol to indicate normal acoustic reflex behaviour. A single stim-

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Acoustic Reflex testing

ulus frequency (1000 Hz is recommended) with 226 Hz probe tone is presented ipsilaterally. If the reflex is not detected within normal stimulus levels in relation to the pure tone audiogram, a complete and thorough acoustic reflex threshold investigation is recommended.

Infant testing

Acoustic reflex testing may also be used for infant screening purposes. The main objective is to confirm general middle ear function. For this purpose, a test protocol using a 1000 Hz probe tone, ipsilateral stimulation and broad band noise stimulus is recommended.

App. 2.3.2

Acoustic Reflex Threshold

The reflex threshold is the lowest stimulus level at which a measurable reflex is elicited. The acoustic reflex is typically considered present when deflections are 0.02 mmho or greater, and a reflex growth can be confirmed (larger deflections observable with increasing stimulus intensities).

The reflex threshold is highly stimulus dependent, for instance broad band noise has proven to elicit the reflex at stimulus levels about 15-20 dB lower than pure tone stimuli. There may also be differences in detectability depending on the pure tone signal frequency that is used.

Acoustic reflex testing involves high stimulus levels, which are used to elicit the reflex.

These high sound levels may be unacceptable to some patients.

App. 2.3.3

Acoustic reflex decay

The acoustic reflex decay adaptation test is used to investigate whether the stapedius muscle contraction can be sustained during prolonged stimulation. A pure tone stimulus at 500 Hz or 1000 Hz is presented 10 dB above the acoustic reflex threshold for

10 seconds. A 226 Hz probe tone is used. Adaptation is considered present if the deflection is decreased by  50% of the initial magnitude. The point in time after stimulus onset when the 50% criterion is reached is referred to as half-life time and is reported as the test result.

A half-life time less than either 5 seconds or 10 seconds are typically taken to indicate retrocochlear pathology. The two different time criteria have been used by different researchers. The acoustic reflex is more prone to adaptation with higher stimulus frequencies. Accordingly, adaptation to the 500 Hz stimulus is considered a stronger indicator of abnormality than adaptation to the 1000 Hz stimulus.

228

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

ETF-P (Eustachian Tube Function - Perforated)

App. 2.3.4

Admittance monitoring

The default stimulus level is automatically set to

Off

when no reflex thresholds have been established. This facilitates admittance monitoring done in order to evaluate baseline fluctuations resulting from for instance tensor tympani muscle contractions or interference from vascular flow or eustachian tube dysfunction. The stimulus can of course also be set to

Off

manually, if this type of admittance monitoring is to be done after the reflex thresholds have already been measured.

App. 2.4

App. 2.5

ETF-P (Eustachian Tube Function - Perforated)

ETF-P can be performed on ears with eardrum perforations prior to reconstructive surgery to evaluate whether the middle ear could be ventilated through the Eustachian tube following tympanoplasty. Air must be able to pass through the Eustachian tube in order to equalise the middle ear pressure following reconstructive surgery.

For testing the Eustachian tube function in ears with perforated eardrums (ETF-P), a method different from immittance measurements is used. In ETF-P, the ear air pressure is monitored continuously to detect any airflow through the Eustachian tube.

An initial positive or negative air pressure is applied to the ear through the probe.

Due to the eardrum perforation, the pressure will be applied to both the ear canal and middle ear cavities. The patient is then instructed to swallow some water, which typically causes a functioning Eustachian tube to open. Any pressure equalisation through the tube will show as a sudden pressure drop toward, but not necessarily reaching, atmospheric pressure (0 daPa). This is repeated until the pressure is equalised or until the test time has elapsed. The pressures at which the tube opens and closes are reported as test results.

Typically, an initial build-up of positive pressure will cause the Eustachian tube to open spontaneously. In order to avoid premature spontaneous pressure equalisation related to positive pressure build-up, the pump speed should be kept at a maximum of 50 daPa/s.

The pressure range available for positive and negative pressures (including 400 daPa and -600 daPa) is commonly used in ETF-P testing.

Susceptance and Conductance, B/G

The admittance (Y) of the ear consists of the contribution of the two components

Susceptance (B) and Conductance (G). The admittance magnitude is the vector length derived from the Cartesian graph as described below.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Susceptance and Conductance, B/G

jB (Compliance)

Admittance

Phase angle

G

Conductance

(mmho)

230

-jB (Mass)

App. 2.5.1

Susceptance, B

Susceptance is determined by the ease with which energy flows through the Compli-

ant elements of the ear and the ease of energy flow through the Mass elements of the ear.

Compliant elements are the tympanic and round window membranes, the ossicular ligaments, the middle ear muscles, and the air in the ear canal and middle ear.

Mass elements are the ossicles and the slugs of air in the middle ear mastoid air cells (moving as units without compression or expansion).

The compliance and mass contribution to the total Susceptance is frequency dependent.

Compliant Susceptance is greater with low frequencies and gradually decreases with higher frequencies.

Mass Susceptance is greater with high frequencies and gradually decreases with lower frequencies.

The total Susceptance is the algebraic sum of the positive Compliance and the negative

Mass contributions, jB + (-jB).

Positive Susceptance

If a major portion of the probe tone energy flows through the Compliance elements of the ear, Susceptance is positive. The ear is in this case stiffness controlled.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Susceptance and Conductance, B/G

This is true when the probe tone frequency is less than the resonance frequency of the ear.

Negative Susceptance

If a major portion of the probe tone energy flows through the Mass elements, then the Susceptance is negative. The ear is in this case Mass controlled.

This is true when the probe tone frequency is greater than the resonance frequency of the ear.

Zero Susceptance

If equal amounts of probe tone energy flow through the Compliance elements and

Mass elements, then the Susceptance is zero. The ear is in this case neither stiffness nor Mass controlled. This means that the probe tone frequency is the same as the resonance frequency of the ear.

Baseline compensation

In order to quantify the middle ear Susceptance, it is helpful to baseline compensate the Susceptance curve. This is achieved through subtraction of the ear canal Suscep-

tance.

The tympanic membrane is tensioned with high air pressure so that the probe tone reflects off the tensed tympanic membrane, and accordingly a negligible portion of the probe tone is admitted into the middle ear.

At high pressures, we only measure the Susceptance of the air that is enclosed between the probe tip and the tympanic membrane, resulting in the ear canal Susceptance.

This Susceptance is mainly Compliance Susceptance, since the Mass element in this enclosed air is negligible. The value of the notch in the Susceptance tympanogram can then be determined from the corresponding value on the vertical axis, and the relation of the probe tone frequency to the ear resonance frequency can be estimated according to the above description.

App. 2.5.2

Conductance, G

Conductance is the amount of energy that dissipates as heat due to the friction in the ear system. Friction occurs as a result of contact between moving molecules in the system. Conductance typically increases when more energy reaches the structures of the middle ear when the sweep pressure approaches the tympanometric peak pressure.

Being a frictional element, Conductance can never take a negative value.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Susceptance and Conductance, B/G

App. 2.5.3

B/G viewing of tympanograms

Viewing dual component (B/G) tympanograms is preferable to admittance magnitude (Y) tympanograms in the higher probe tone frequency region.

This is because the Mass elements have an increasingly pronounced impact on the tympanogram with higher frequencies.

When the probe tone frequency approaches the Mass controlled frequency region, the increasing Mass and the decreasing Compliance contribution to Susceptance will pull the Susceptance curve down, and cause notching of the curve. Notching, if sufficiently pronounced, will also show in the total Admittance curve, and may make the curve difficult to interpret, especially with regard to normative data.

High frequency probe tones

Since the B/G viewing is of interest only for high frequency probe tones, this method is clinically valuable in conjunction with multi frequency tympanometry where the normative data is based on resonance frequency. However, even when measuring with a single high frequency probe tone, the B/G components provide a clearer picture of the state of the middle ear, especially when testing the infant population, where the ear is still undergoing maturation and resonance frequency alterations.

App. 2.5.4

Component compensation

Interpretation of tympanograms relating to high frequency probe tones may be difficult, because no straightforward approach is available.

Baseline compensation

In order to assess the middle ear admittance alone, the ear canal contribution to the total ear admittance must be eliminated. This is called baseline compensation.

• Using low frequency probe tones

Baseline compensation is achieved by subtracting simple ear canal admittance from the total admittance, but this is really only valid when using low frequency probe tones such as 226 Hz. The reason is that the middle ear is typically stiffness controlled at 226 Hz, and accordingly the middle ear Mass elements will not influence the admittance curve. Admittance is therefore made up of Compli-

ance and Conductance properties alone.

Compliance and Conductance properties vary similarly throughout the pressure sweep, making it possible simply to subtract the ear canal Compliance and Con-

ductance measured at one extreme point in the pressure sweep. In other words, the stiffness and friction alone contribute equally to each point of the admittance curve throughout the pressure sweep, including the extreme point where the ear canal admittance is determined.

• Using higher frequency probe tones

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Susceptance and Conductance, B/G

The covariation between Susceptance and Conductance is no longer true when the probe tone frequency is increased, approaching a Mass controlled frequency region. As the influence on the Susceptance curve of Mass elements increases when approaching the peak pressure, the relationship between the Susceptance and the Conductance will no longer remain the same throughout the pressure sweep. When this happens, you can no longer subtract the ear canal admittance

(measured at one extreme point of the sweep) from each point of the total admittance curve.

• Baseline compensation for Susceptance and Conductance curves

However, using baseline compensation is appropriate for the Susceptance and the

Conductance curves individually. I.e. you can subtract the isolated ear canal Sus-

ceptance measured at e.g. +200 daPa from every Susceptance point throughout the sweep, taking variations in Mass and Compliance contribution into account.

Likewise, you can subtract the ear canal Conductance from each point of the

Conductance curve. After these separate component compensations, the middle ear admittance can be correctly calculated from the two compensated Suscep-

tance and Conductance curves.

The resulting admittance tympanogram

Each point of the resulting admittance tympanogram describes the difference from the admittance of the ear canal alone.

Since an absolute difference cannot be negative, the admittance values in the component compensated admittance curve will always have a positive value throughout the curve, and even a notched non-compensated admittance tympanogram will typically become single peaked when compensated through this procedure. The reason for this is that regardless of whether the admittance change is due to a change in Mass or

Compliance contribution, it is still an absolute change relative to the ear canal admittance reference point.

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App. 2 MADSEN OTOflex 100 Immittance Methodology and Features

Susceptance and Conductance, B/G

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App. 3 Glossary

App. 3.1

Otometrics

Terminology

Symbols/characters

226 Hz tymp unit The unit used for tympanograms measured with 226 Hz probe tone. A selection of volume units (cc, cm

3

, and ml) and mmho is available. Does not apply to measurements made at 1000 Hz probe tone where the mmho unit is always used.

A

Absolute (Abs)

Admittance (A) The admittance of the ear canal, tympanic membrane (ear drum) and middle ear system (the total (sum) of admittance of the 3 components)

Alkaline battery

Altitude above sea level

Disposable battery type (not rechargeable)

Lets the user enter a height in metres. Used to compensate for barometric pressure

Ante meridiam (am) Before noon

Audible seal status volume

Audible test status volume

Auto delete test

The volume of audible seal status feedback. Can be turned off (0 volume).

The volume of audible test status feedback. Can be turned off (0 volume).

Automatically delete test results when they have been successfully reported or uploaded to the PC.

Auto new Patient

Folder

Start of the first measurement after reporting will cause the test device to store results in a new patient folder (N/A for online measurements)

Auto resume on seal Directs the test device to automatically continue an interrupted test when a seal is obtained.

235

App. 3 Glossary

Terminology

236

Auto settings

Auto start on seal

Settings controlling an automatically performed measurement

Directs the test device to automatically initiate a test when a seal is obtained.

A search for the reflex threshold for a set of stimulus types.

Automatic reflex threshold measurement

Automatically select next tymp curve upon start (Auto next)

Increase tympanogram curve number at each new tymp measurement.

B

Baseline

Baseline compensation

Battery indicator

Battery type

Bluetooth

Broad band noise

(BBN)

Reference admittance value. For tymp, the reference admittance is conventionally measured at 200 daPa ear canal pressure where the contribution from the middle ear is small. For reflex measurements, the baseline is the compliance without an applied stimulus.

Subtraction of baseline admittance from the result before presentation.

Rough indication of the remaining battery capacity

NiHM or Alkaline

A type of wireless radio communication commercially available for PC equipment

Stimulus type covering a mix of frequencies across the full stimulus spectrum

C

Cable clip

Cable holder

Calibration

Accessory used with the shoulder harness

Fork for the charger/cradle desktop base into which a probe cable can be placed to prevent the probe from falling to the floor.

Measurement and storage of the frequency specific correction factors needed to produce a linear probe characteristic

Otometrics

Otometrics

App. 3 Glossary

Terminology

Cap

Charger/cradle

Closing pressure

Compliance (C)

Connect

Contralateral (Contra)

Control panel

Transparent plastic part into which the probe can be mounted. Provides a better grip for the probe. Can be mounted on the test device. Allows a screening handle to be inserted.

Charger/cradle designed for test device charging and desktop (or wallmount) operation

The pressure at which the Eustachian tube closes

Synonymous for admittance. The term compliance is used when admittance is used in volume units (not mmho).

Establish radio connection via Bluetooth

Opposite side (ear) to where the measurement is performed

A vertical pane with controls to remote control testing from the PC

D

Decibel (dB)

Deflection

Intensity unit

Change in admittance caused by contraction of the stapedius muscle. The contraction is provoked by applying a stimulus in the same (ipsilateral) or opposite (contralateral) ear.

Deflection scale

Deflection scale type

(linear/logarithmic)

The maximum value of the admittance scale for display of deflections.

Determines if the deflection scale for a reflex decay measurement must be linear or logarithmic.

Deflection threshold The minimum deflection value regarded as sufficient to safely distinguish between a present or absent reflex response.

Deflection unit used for measurements with 226 Hz probetone (226 Hz

(deflection) unit)

The unit used for deflection curves measured with 226

Hz probe tone. A selection of volume units (cc, cm

3

, ml, and micro litres) and mmho is available. Does not apply to measurements made at 1000 Hz probe tone where the mmho unit is always used.

237

App. 3 Glossary

Terminology

238

E

Ear select

Eartip

Equivalent ear canal volume (ECV)

Eustachian tube function test with intact tympanic membrane (ETF-I)

Eustachian tube function test with perforated tympanic membrane (ETF-P)

Selection of the patient ear that measurements will be viewed for or performed on

Disposable soft silicone part used to create a seal between the probe and the patient's ear. For the contra insert phone, eartips made from soft foam is used (do not require a seal).

The volume of the ear canal (measured at 226 Hz probe tone)

A set of tympanograms is recorded. Between each recording the patient is manipulated to provoke a change in middle ear pressure by allowing air to pass through the

Eustachian tube.

The pressure applied to the ear canal passes the perforated tympanic membrane and can pass directly through the

Eustachian tube. The pressure is recorded as a function of time.

F

Factory defaults

First ear to test (First ear)

Factory installed default settings

Applies when testing starts on a new patient.

G

Get test results from device

Fetch results from the test device test memory to the PC.

H

Hearing level (HL) Intensity level scale adjusted to a normal hearing profile

High band noise

(HBN)

HIMSA

Hour (hr)

Stimulus type covering a mix of frequencies in the high end of the stimulus spectrum

Manufacturer of NOAH and PAX software

Hour

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App. 3 Glossary

Terminology

I

Immittance

Infant eartip

Initial pressure polarity

Intensity safety off

Contraction of impedance and admittance. The term covers all the tests types.

Tree shaped eartips for tiny ears

Determines whether an ETF-P test starts with a test at positive or negative applied pressure.

A mode where the safety limits are temporarily disabled (a warning is displayed on the display as long as this mode is active). Implemented for research purposes.

Inter stimulus pause The pause imposed between deflection recordings

Ipsilateral (Ipsi) Refers to stimulus applied to the same ear as where the measurement is performed

L

Layered tympanograms

Leak

Leak indicator

License

License info

Low band noise

(LBN)

Up to 3 tympanograms can be shown at the same time in the same graph.

An insufficient seal between the eartip and the ear canal wall causes air to leak in or out of the ear canal making it difficult or impossible to conduct a measurement

Angraphical (or audible) indication of the leak status on the display

A permission to use a certain functionality

Displays info about the currently installed licenses

Stimulus type covering a mix of frequencies in the low end of the stimulus spectrum

M

Maintain pressure

(for reflex measurements)

Maintain pressure

(manual tympanometry)

The test device will actively try to maintain the target pressure (typically TPP) in case of slight leaks.

The test device will actively try to maintain the set pressure in case of slight leaks when the user stops adjusting the pressure.

239

App. 3 Glossary

Terminology

240

Manual tympanometry

Max stimulus intensity

Tympanometric test where the user controls the applied pressure manually.

The highest applied stimulus intensity during reflex screening or automatic reflex threshold.

Maximum positive pressure

The maximum positive pressure that may be applied during the ETF-P test. The pressure will often not be reached as a spontaneous opening of the Eustachian tube may occur at a lower pressure.

Maximum pressure The maximum applied pressure (positive pressure value) for tympanometry. Acts also as the starting pressure for negative sweep direction.

Menu A list of selectable items

Middle ear pressure

(MEP)

The pressure of the middle ear. Roughly indicated by the tympanic peak pressure.

Minimum pressure The minimum applied pressure (negative pressure value) for tympanometry. Acts also as the starting pressure for positive sweep direction.

Minute (min) Minute

Modified Jerger

Month (mm)

Mushroom

The name of internationally recognized normal region and tymp classification.

Month

Shape of standard eartip

N

Negative target pressure

NiMH

NOAH action

NOAH session

NOAH System

(NOAH)

The highest negative pressure that will be applied during the ETF-P test. The pressure will be reached as there is no spontaneous opening of the Eustachian tube for negative pressures

Rechargeable battery type

A collection of test results relating to one patient and one ear

A collection of NOAH actions for one client

Standardized software for PC allowing conduction of tests and storage of results from hearing assessments and hearing instrument fittings

Otometrics

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App. 3 Glossary

Terminology

Norm type

Normal region

(Norm)

The name of the normal region/classification system used. The only implemented norm in release 1 is the modified Jerger

Established reference ranges for e.g. admittance and tympanic peak pressure based on measurements on a large group of normal individuals. The normal area can be visualized as a square box in the tympanogram graph.

O

Opening pressure

Otometrics

OTOsuite

Output intensity safety limits

The pressure at which the Eustachian tube opens.

Manufacturer of OTOflex and OTOdiagnostics Suite

The name of the PC software package that communicates with the test device and additional device.

A set of fixed stimulus intensity safety limits apply to each reflex test type and stimulus side.

P

Patient

Patient Folder

The person being tested (the term client is used in

NOAH)

A collection of test results relating to one patient, both ears (refer also to NOAH action)

Phase compensation Admittance differences (static compliance/static admittance/deflection) results from a subtraction of 2 admittance values. Admittance has both an amplitude and phase. The phase compensation takes phase differences into account during subtraction to produce more accurate results.

Post meridiam (pm) After noon

Post-stimulus time

Pre-stimulus time

Pressure

The delay from the end of the applied stimulus to the end of recording of the deflection curve during a reflex measurement.

The delay from the start of recording of the deflection curve to applying the stimulus during a reflex measurement.

Air pressure (e.g. applied to the ear canal)

241

App. 3 Glossary

Terminology

242

Pressure offset

Pressure range

Pressure release

Pressure sweep direction

Probe check

Probe tone

Procedure options

Pump speed

A pressure relative to the tympanic peak pressure (used during reflex measurements).

The outher boundaries for the applied pressure for tympanometry

An instant change to atmospheric pressure in the ear canal

The direction in which the pressure is changed during tympanometry.

A test performed in the test cavity to verify correct function of the probe and optionally to adjust the cavity readout

The frequency of the steady tone emitted by the probe during measurement of admittance (226 Hz or 1000 Hz)

Basic settings controlling device behaviour in relation to tests

The pressure gradient used during an automatic (standard) tympanometry or for an ETF-P test where the pressure build-up is controlled automatically.

R

Reflex Contraction of the stapedius muscle caused by applying a loud sound stimulus. The contraction is measured as a change in admittance in the middle ear due to stiffening of the ossicular chain and related structures such as the tympanic membrane

Reflex decay

Reflex decay test

(RD)

The adaptation phenomenon through which an elicited reflex decrease in magnitude over time even when the provoking stimulus is maintained.

Test showing how fast (in seconds) the reflex decays to half its maximal magnitude.

Reflex half-life time The result of the reflex decay test (time from stimulus onset to the deflection decays to half its maximum magnitude)

Reflex screening

(RS)

A quick assessment of whether the reflex reaction is present or not in a subject (patient) ear. The test typically involve a quite strong stimulus that is expected to elicit the reflex in normal subjects.

Otometrics

Otometrics

App. 3 Glossary

Terminology

Reflex screening result a) An indication of whether a reflex was detected or not at a single stimulus intensity

Reflex threshold

Reflex threshold test

(RT)

Reflex threshold verification

Report b) An indication of the lowest intensity at which a reflex was detected (up to 3 intensities used)

The lowest stimulus intensity that can elicit a reflex.

A search for the reflex threshold made by applying stimuli at increasing intensities until a reflex is detected.

Defines how the result of an automatically performed reflex threshold test is verified (Stop, Repeat (test at same intensity), Include next (intensity), Include next 2 (intensities))

A printout containing all test results for the patient

S

Screening eartip

Screening handle

Seal

Start stimulus intensity

Umbrella shaped eartip to be pressed against the ear canal opening rather than being inserted into the canal

An ergonomic handle that can can be inserted into the probe holder to improve the grip (the probe handle may be mounted on the device)

Hermetic tightness between the eartip and the ear canal wall

A search for the reflex threshold for a single stimulus type Semi-automatic reflex threshold measurement

Shoulder harness Accessory placed over the patient's shoulder to which probe cables can be fixed via a cable clip to relief strain

Scientific intensity level scale Sound pressure level

(SPL)

Standard eartip

Start pressure

Mushroom shaped eartip for normal sized ears

The starting pressure for manual tympanometry. The device will automatically apply the starting pressure before the manual control takes effect.

The intensity used initially in search for reflex thresholds.

243

App. 3 Glossary

Terminology

244

Static admittance

(SA)

Static compliance

(SC)

Stimulus

Stimulus intensity

System info

Similar to static compliance. The term static admittance is used when the admittance unit is mmho.

The difference between the peak admittance value and the baseline admittance value. This difference approximates/equals the admittance fo the middle ear. The term static compliance is used when a volume unit is chosen for the admittance.

A sound applied to the ear to provoke a reflex response.

The intensity of the stimulus measured relative to the hearing threshold for normal individuals (dB HL)

Stimulus intensity increment

Stimulus intensity steps

The difference from one stimulus intensity to the next used during a search for a reflex threshold (measured in dB).

The maximum number of stimulus intensities that may be used during a reflex screening test to provoke a reflex response (1, 2, or 3)

Stimulus output side The side where a stimulus is applied relative to the side where the response is measured. Same side: Ipsilateral.

Opposite side: Contralateral.

Stimulus time The duration of the stimulus during a reflex measurement.

Stimulus type (Type) A pure tone at a given frequency or a given filtered noise.

Stop on results A stop criterion for the automatic tymp sweep. The measurement may stop when the needed information is available rather than waiting for the pressure sweep to reach the pressure boundary.

Swap ear results Swaps currently recorded data between ears (used to correct mistakes)

Displays info about the software and hardware versions and memory usage.

T

T

Test cavity

Tympanometry, tympanogram

A well defined cavity used to test/adjust volume readings and probe function.

Otometrics

Otometrics

App. 3 Glossary

Terminology

Test device

Test mode

Test selector

Test sequence

Test settings

A physical apparatus like OTOflex 100 used for assessment of the hearing or balance condition of a patient

A mode where the currently selected test or test sequence can be controlled.

A mode where the test device scroll wheel is used to browse results from the current patient and to select a new test.

A sequence of 2 or more different test types (e.g. tymp and reflex screening)

All settings controlling how a measurement is performed.

The current measurement settings can be named and saved. Saved settings can be recalled and used as current settings.

Date and time of the measurement/patient folder Time stamp

Tool bar

Tree-tip

Tymp

Tymp auto scale

A collection of tool buttons placed as a horizontal strip in theupper part of the application window

Synonymous for infant eartip

The curve showing the result of the tympanometry test

Setting directing the tympanogram scale to adapt to actual tympanogram hight (peak admittance value)

Tymp classification Classification of the shape and peak position of a tympanogram in regards to normal data according to an established standard.

Tymp scale

Tympanogram curve number (Tymp curve/Tymp)

The maximum value of the admittance scale for display of tympanograms.

Numbering of tympanograms that are memorized separately and may be layered.

Tympanogram gradient (Grad)

A horisontal line divides the tymp curve at the height where TPP ± 50 daPa intersects with the tympanogram.

The gradient is the ratio between the peak height from this horisontal line, and the total peak height measured from the positive tail.

Tympanogram width The width of the tympanogram measured at half the tympanogram height (halfway between the positive tail and peak Y values). Width is given in daPa.

245

App. 3 Glossary

Abbreviations

Tympanometric peak pressure (TPP)

Tympanometry

The pressure at which the peak of a tympanogram is found. If multiple peaks occur, the TPP is n/a.

Measurement of admittance as function of applied ear canal pressure. The pressure is usually controlled automatically acccording to pressure settings (minimum pressure, maximum pressure, pressure sweep direction, and pump speed).

U

User The user doing the testing

V

View

View settings

A set of graphical elements presenting test results with focus on one or two test types

All settings controlling the presentation of results. View settings cannot be saved explicitly, but will be remembered automatically.

W

Wallmount

Y

Year (yy)

Z

Zodiac

Shelf designed for the test device.

Year

Another immittance device from Otometrics

App. 3.2

Abbreviations

Abs

A am

BBN

C

Absolute

Admittance

Ante meridiam

Broad band noise

Compliance

246

Otometrics

Otometrics

Contra dB

ECV

ETF-I

ETF-P

SA

SC

SPL

T

TPP pm

RD

RS

RT

HL

HBN hr

Ipsi

LBN

MEP

NiHM

App. 3 Glossary

Abbreviations

Contralateral

Decibel

Equivalent ear canal volume

Eustachian tube function test with intact tympanic membrane

Eustachian tube function test with perforated tympanic membrane

Hearing level

High band noise hour

Ipsilateral

Low band noise

Middle ear pressure

Battery type, rechargeable

Post meridiam

Reflex decay test

Reflex screening test

Reflex threshold test

Static admittance

Static compliance

Sound pressure level

Tympanometry, tympanogram

Tympanometric peak pressure

247

App. 3 Glossary

Abbreviations

248

Otometrics

App. 4 MADSEN OTOflex 100 Icons

App. 4.1

The following icons are used in OTOflex 100:

Navigation and editing symbols

Arrow left

Arrow right

Cancel

Curve marker

Delete

Ear left

Ear right

Insert

Mark

Unmark

Menu

Test or character select mode

Patient

Play

Pressure build-up positive, ETF-P

Pressure build-up negative, ETF-P

Otometrics

249

App. 4 MADSEN OTOflex 100 Icons

Powering

Return to previous menu

Return to test screen

Start semi-automatic testing

Start automatic testing

Stimulus

Stop testing

App. 4.2

Powering

Battery status: empty

Battery status: good

Battery status: normal

Powered by charger

App. 4.3

Communication

Bluetooth communication disabled

Bluetooth communication enabled. OTOflex 100 connected to OTOsuite

OTOflex 100 disconnected from OTOsuite

Printer

App. 4.4

Messages

error message info message

250

Otometrics

App. 4.5

Leakage

warning_message

App. 4 MADSEN OTOflex 100 Icons

Leakage

Probe leak status: blocked

Probe leak status: leak

Probe leak status: not inserted

Probe leak status: OK

Otometrics

251

App. 4 MADSEN OTOflex 100 Icons

Leakage

252

Otometrics

App. 5 Troubleshooting

App. 5.1

Powering

Problem

OTOflex 100 does not power on even though I press the power button.

Possible cause

• The batteries are inserted incorrectly.

OTOflex 100 powers off and cannot power on even though I press the power button.

The charging indicator does not light up when I place

OTOflex 100 in the charger.

• The batteries need charging

(if rechargeable) or replacing.

The batteries need charging (if rechargeable) or replacing.

• The charger is not connected to the electrical power supply.

Solution

• Insert the batteries correctly.

• Charge the batteries (if rechargeable) or fit OTOflex 100 with new batteries.

Charge the batteries (if rechargeable) or fit OTOflex 100 with new batteries.

• Connect the charger to the electrical power supply.

• There are no batteries in the

OTOflex 100 unit, or the batteries are inserted incorrectly.

• Place batteries in the battery compartment and make sure they are inserted correctly.

• Wrong battery type.

App. 5.2

Testing

Problem

I forgot to switch to the correct ear in OTOflex 100 before testing.

Possible cause Solution

See 8.2 Swap ear results  101

.

Otometrics

253

App. 5 Troubleshooting

Communication

App. 5.3

Communication

Bluetooth communication failure

Bluetooth

Problem

Installation of driver software on

WIN98 PC

Possible cause

The file ‘bcbthub.sys’ on Bluetooth Install Disk cannot be found.

Bluetooth communication fails and cannot be restored

Solution

You may get this error when installing the IOGEAR Bluetooth driver on a

Windows 98 PC.

In the

Copy fields from

field, write

“C:\WINDOWS\SYSTEM” and press

OK

to continue.

Remove the USB Bluetooth dongle and reinsert.

Test device

Problem

The wrong test device was selected.

Test device does not perform correctly

Air hose/cable connection problems

Possible cause Solution

See 5.1.1 Selecting test devices  45

Battery status low in test device.

Recharge the test device.

Check the connections. See

6.3 Preparing OTOflex 100  50 .

App. 5.4

Problem

Leakage

Probe-fit related problems

Leakage

Possible cause

Leakage can be caused by a number of factors, such as:

Solution

• Pneumatic/probe plug not inserted properly.

• Inappropriate ear tip size (either too small or too large).

• Ear canal debris blocks for good ear tip seal.

254

Otometrics

App. 6 Technical Specifications - MADSEN

OTOflex 100

App. 6.1

OTOflex 100

App. 6.1.1

Compliance measuring system

Probe tone:

THD:

Frequency accuracy:

Range:

226Hz @ 85dBspl ± 1.5dB

1000Hz @ 75dBspl ± 1.5dB

< 3% in 2 cc

±0.5%

0.1 ml to 8.0 ml ± 5% or 0.1 ml whichever is greater

App. 6.1.2

Acoustic Reflex

Contralateral Stimulation

Pure tones:

Frequency accuracy:

Noise

Range at:

Step size dB

E-A-RTONE® 3A:

500Hz, 1000Hz, 2000Hz, 3000Hz, 4000Hz

± 0.5%

White Noise according to IEC 1027

Low Pass 400 to 1600 Hz.

High Pass 1600 to 4000 Hz.

Roll off >12 dB/Octave.

BBN, LPN at 50 to 100 dB HL ±3 dB

HPN at 50 to 95 dB HL ±3 dB

1, 2, 5, 10 dB

Otometrics

255

App. 6 Technical Specifications - MADSEN OTOflex 100

OTOflex 100

Range at: 500Hz at 50 to 105dB HL ± 3dB

1000Hz at 50 to 120dB HL ± 3dB

2000Hz at 50 to 115dB HL ± 3dB

3000Hz at 50 to 105dB HL ± 3dB

4000Hz at 50 to 110 dB HL ± 3dB

< 3% in 2 cc (measured 5 dB below max output) THD:

Immittance probe:

Range at:

THD:

500Hz at 50 to 105dB HL ± 3dB

1000Hz at 50 to 120dB HL ± 3dB

2000Hz at 50 to 115dB HL ± 3dB

3000Hz at 50 to 105dB HL ± 3dB

4000Hz at 50 to 110 dB HL ± 3dB

< 3% in 2 cc (measured 5 dB below max output)

Ipsilateral Stimulation

Tone:

Frequency accuracy:

Noise

Step size dB:

Range at:

THD:

500Hz, 1000Hz, 2000Hz, 3000Hz, 4000Hz

± 0.5%

White Noise according to IEC 1027

Low Pass 400 to 1600 Hz

High Pass 1600 to 4000 Hz

Roll off >12 dB/Octave

1, 2, 5, 10 dB

500Hz at 50 to 105dB HL ± 3dB

1000Hz at 50 to 120dB HL ± 3dB

2000Hz at 50 to 115dB HL ± 3dB

3000Hz at 50 to 105dB HL ± 3dB

4000Hz at 50 to 110 dB HL ± 3dB

< 3% in 2 cc (measured 5 dB below max output)

App. 6.1.3

Air pressure system

Range:

Pressure sweep rate:

Normal +200 to -400 daPa/s,

Extended +400 to -600 daPa/s

50, 100, 200, 400 daPa/s, A.F.A.P

A.F.A.P. will start at 500 daPa/s and slow down to 400 daPa, when at peak is detected.

256

Otometrics

App. 6 Technical Specifications - MADSEN OTOflex 100

Charger unit

Pressure accuracy: ±10% or ±10 daPa, whichever is greatest

Pump measure direction: Positive to negative or negative to positive

Safety: Separate safety +530 daPa and -730 daPa. ±70 daPa

Software safety +450 daPa and -650 daPa. ±70 daPa.

App. 6.1.4

Unit of admittance graph Y-axis

ml, cc, mmho, μl

App. 6.1.5

Unit of graph X-axis

daPa, sec

App. 6.1.6

Display

Graphic 128x128 dots

App. 6.1.7

Interface

Wireless Bluetooth data transfer to PC

App. 6.1.8

Type identification

OTOflex 100 is type 1012 from GN Otometrics A/S

App. 6.1.9

Power supply

Battery types: Rechargeable (Ni-MH type) AA (R6) 1.2V, 4 pcs.

Use only rechargeable batteries supplied by GN Otometrics A/S

Alkaline AA (R6) 1.5V, 4 pcs.

Battery supply voltage: Nom. 5V, max. 6.4V, min. 4.0V (instrument power off voltage)

App. 6.2

Charger unit

Type identification: Charger unit is type 1012 Charger from GN

Otometrics A/S

Otometrics

257

App. 6 Technical Specifications - MADSEN OTOflex 100

Operating environment

Power:

Power consumption

100 - 240 VAC ±10%, 50/60 Hz

< 10VA

App. 6.3

App. 6.4

Operating environment

Temperature:

Rel. humidity:

Warm-up time:

Air pressure:

+15°C to +35°C (59°F to +95°F)

30 to 90 %, non-condensing

< 2 min.

600 hPa to 1060 hPa

Operation at temperatures below -20°C or above +60°C may cause permanent damage.

Storing and handling

Temperature:

Rel. humidity:

Air pressure:

-20°C to +60°C (-4°F to +140°F)

< 90 %, non-condensing

500 hPa to 1060 hPa

App. 6.5

Dimensions

OTOflex 100 (HxWxD): 20 cm x 4.9 cm x 7.8 cm (7.9” x 1.9” x 3.0”)

Charger unit (HxWxD): 8 cm x 4.9 cm x 7.8 cm (6.9” x 1.9” x 3.0”)

App. 6.6

Weight

OTOflex 100:

Charger unit:

App. 6.7

Miscellaneous

2cc coupler.

0.6 kg/1.3 lb

0.23 kg/0.5 lb

258

Otometrics

App. 6.8

App. 6.9

App. 6 Technical Specifications - MADSEN OTOflex 100

Calibration

Clock and calendar.

Calibration

Equipment should be calibrated regularly according to EN 61027 and ANSI S3.39

Standards

Safety: EN 60601-1, UL 2601-1, CAN/CSA -C22.2 NO

601.1-90

OTOflex 100: EN 60601-1, Class II, Internal Powered,

Type BF, IPX0

Charger unit: EN 60601-1, Class II, IPX0

EMC: EN 60601-1-2, EN 300 328-2, EN 301 489-17

Impedance/Admittance: EN 61027 Type 1, ANSI S3.39 Type 1

Otometrics

259

App. 6 Technical Specifications - MADSEN OTOflex 100

Standards

260

Otometrics

Index

A B C

D E F G H

I J K L M N O P

Q R S

T U V

W

X Y Z

A

Acoustic Reflex

description 226

infant testing 228

screening settings 153

testing 81

threshold settings 156

Acoustic Reflex Decay

automatic testing 122

description 228

manual testing 123

testing 121

Acoustic Reflex Screening 110

description 227

screening mode, softkeys 72

83

84

91

97

settings 153

Acoustic Reflex Threshold

automatic test 115

description 228

manual test 119

settings 156

testing 114

viewing results 86

Admittance

monitoring 229

Advanced settings 144

Altitude setting 146

Auto resume on seal

setting 142

Auto scaling

setting 151

Auto start on seal

setting 142

Autoclaving 194

B

Baseline compensation

tympanometry setting 149

baseline compensation 171

Batteries

Alkaline 206

inserting 207

NiHM 206

power off mode 147

power save mode 146

rechargeable 206

set type in device 208

Battery type

settings 146

BBN

setting, acoustic reflex threshold 159

Bluetooth

enabling 210

enabling communication 146

Brightness

device setting 146

C

Calibration 192

Cap

attaching 51

detaching 54

use with handgrip 56

cc

setting, tympanometry 143

Charger

charging status 210

desktop installation 203

first time use 210

power off mode 147 power save mode 147

powering 209

view 201

wall mount installation 204

Cleaning

autoclaving 194

device 195

probe 192

probe test cavity 194

cm

3

probe tip 193

setting, tympanometry 143

Communication

interruption 131

sending to OTOsuite 132

synchronization 103

131

Configuration Wizard 213

Contra

setting, acoustic reflex screening 154

261

Otometrics

Index

A B C

D E F G H

I J K L M N O P

Q R S

T U V

W

X Y Z

Contral

stim output setting, acoustic reflex threshold 161

stimulus side setting, acoustic reflex decay 165

Curve Selector 30

Curves

auto next curve setting 150

layered c. ETF-I, setting 152

layered c. tympanometry, setting 149

overwriting, setting 150

D

Data

clean-up 133

delete measurements 101

editing data 29 entering data 29

management 131

sending to OTOsuite 132

synchronization 103

131

Date format 148

Deflection

unit 143

Deleting data 133

Device

icons 249

Device info 146

Device settings 145

Diagnostic tympanometry 80

112

Display

icons used 249

view 24

Disposal

batteries 196 eartips 196

E

Ear

leakage 64

swap results 101

Ear selection

ear selector key 23

68

setting 143

Eartips

disposal 196

EBV

see ECV 224

ECV

description 224

Editing data 29

Entering data 29

Equivalent ear canal volume 224

ETF-I 114

description 225

layered curves 152 settings 152

Toynbee’s maneuver 226

Valsalva’s maneuver 226

ETF-P 125

description 229

Eustachian tube function

see ETF-I or ETF-P 225

229

F

Firmware update, test devices (Imm.) 46

G

General actions

my settings 139 new patient folder 139 patient & user 139 start sequence 139 test selector 139

H

Half-life time

description 228

Handgrip

attaching 55

detaching 56 use with cap 56

HBN

setting, acoustic reflex threshold 159

Hotkeys

general test functions 68

tympanometry test functions 76

262

Otometrics

A B C

D E F G H

I

Index

J K L M N O P

Q R S

T U V

W

X Y Z

I

Icons

autoscaling 35

get test results 34

select and manage test devices 35 select curve 35 show admittance data 35 show conductance and susceptance data 35 toggle reflex curve 35

used in device 249

Immittance 33

introduction 221

Immittance Module

user interface 33

Insert phone

connecting to device 51

Intensity

safety, setting 144

setting, acoustic reflex screening 155

setting, acoustic reflex threshold 161

start i. setting, acoustic reflex threshold 162 step size setting, acoustic reflex

Ipsi

threshold 162

setting, acoustic reflex screening 154

stim output setting, acoustic reflex threshold 161

stimulus side setting, acoustic reflex decay 165

J

Jerger

224 classification system 224

setting 151

K

Keypad

ear selector/pressure release 23

68 general test functions 68

main functions 23

Menu softkeys 25

On/Off 23

69

210

scroll wheel 22

69

select key 22

28

69

softkeys 23

68

Test Selector softkeys 28

tympanometry test functions 76

L

Language selection 148

Layered curves

setting, ETF-I 152

setting, tympanometry 149

LBN

setting, acoustic reflex threshold 159

Leakage 64

Localization 148

M

Maintenance

cleaning device 195

Manufacturer 219 responsibility 219

Max intensity

setting, acoustic reflex screening 155

setting, acoustic reflex threshold 161

Measurement setup

creating 138 editing 138 using 138

Measurement unit

tympanometry 143

Menu 25

31

accessing 25

30

ml

setting, tympanometry 143

mmho

setting, tympanometry 143

N

Navigation, Immittance Module 33

Next patient 64

No power off before mode 147

Norm type

setting 151

P

Patient

auto create new 144

Otometrics

263

Index

A B C

D E F G H

I J K L M N O P

Q R S

T U V

W

X Y Z

Patient folders

description 58

Powering

battery status 209

battery types 206

charger 209

device 206

first time charging 210

Preparations

before next patient 64

connecting probe and insert phone 51

creating user 61 deleting user 61

device 50

first patient of the day 59

probe 50

selecting user 60

Preparing for testing

Tympanometry 20

Pressure

initial, setting, ETF-P 166 negative, setting, ETF-P 166 positive, setting, ETF-P 166

range, setting 150 setting max. 150 setting min. 150

Pressure release key 23

68

Probe

cleaning and maintenance 192

connecting to device 51 detaching 51

standard 148

view 202

wax filter 195

Probe test cavity

cleaning 194

Probe tip

cleaning 193

cleaning procedure 194

Probe tone

acoustic reflex decay setting 163

acoustic reflex screening setting 153

acoustic reflex threshold setting 156

tympanometry setting 148

Procedure option settings 141

Pump

active during stimulation, acoustic reflex decay 163

active during stimulation, acoustic reflex threshold 157

active during stimulation, ART 184

187

speed, ETF-P 166

speed, screening tympanometry 152

speed, tympanometry 151

R

Rechargeable batteries 206

Reflex Decay, automatic 92

Reflex Decay, manual 95

97

Reflex screening 110

Reflex testing

Decay, automatic 92

Decay, manual 95

97

Threshold, automatic and semiautomatic 84

Threshold, manual 88

Reflex Threshold, automatic and semiautomatic 84

Reflex Threshold, manual 88

Results

deleting 102

tympanometry on-screen 79

viewing Acoustic Reflex Threshold 86

S

SA

description 223

Safety

Audiometry Module 215

warning notes 217

Safety information 197

Screen

icons used 249

Screening

Acoustic Reflex 110

Tympanometry 109

Screening tympanometry 71

109

settings 152

264

Otometrics

A B C

D E F G H

I

Index

J K L M N O P

Q R S

T U V

W

X Y Z

Scroll wheel 22

69

Select key 22

28

69

Sequence

selecting setup 167

setup setting 142

Settings

’Done’ prompt 144

’Settings’ prompt 144

226 Hz deflection unit 143

226 Hz tymp unit 143

advanced settings 144

altitude above sea level 146

auto free memory 143

auto next curve 150

Auto resume on seal 142 auto start on seal 142

baseline compensation, tympanometry 149

battery power off 147

battery power save 146 battery type 146 bluetooth 146 brightness 146

changing... 135

charger power off 147 charger power save 147

creating setup 138

custom max. pressure 150 custom min. pressure 150

custom TPP offset, ART 182

184

186

188

date format 148

deflection scale 158

159

160

162

164

165

185

188

deflection scale, acoustic reflex decay 164

deflection scale, acoustic reflex threshold 158

delete all patients 141

delete all printed patients 140 delete current test 140 delete measurement 140 delete test 140

device info 146

device settings 145 dissociate from 145

editing setup 138

First ear to test 143

for acoustic reflex screening 153

for acoustic reflex threshold 156

for ETF-I 152 for screening tympanometry 152

for tympanometry 148

initial pressure 166 initial time scale 166

intensity increment, acoustic reflex screening 155

intensity increment, AR screening 181

184

intensity safety 144

intensity step size, acoustic reflex threshold 162

language selection 148

layered curves, ETF-I 152

layered curves, tympanometry 149

load patient 140

localization 148

manage test results 139

max intensity, acoustic reflex screening 155

max intensity, acoustic reflex threshold 161

negative pressure 166

no of intensities, acoustic reflex screening 155

no power off before 147

norm type 151

patient prompt 144

pause time 165

pause-time 162

185

188

positive pressure 166

post-stim time, acoustic reflex decay 164

post-stim time, acoustic reflex threshold 160

post-stim time, ART 185

188

pressure range 150

pre-stim time, acoustic reflex decay 164

pre-stim time, acoustic reflex threshold 159

pre-stim time, ART 185

188

print when done 144

probe standard 148

probe tone, acoustic reflex decay 163

probe tone, acoustic reflex screening 153

probe tone, acoustic reflex threshold 156

probe tone, tympanometry 148

procedure options 141

Otometrics

265

Index

A B C

D E F G H

I J K L M N O P

Q R S

T U V

W

X Y Z

pump during stimulation, acoustic reflex decay 163

pump during stimulation, acoustic reflex threshold 157

pump during stimulation, ART 184

187

pump speed 151

pump speed, ETF-P 166

pump speed, screening tympanometry 152

reflex criterion, acoustic reflex screening 156

reflex criterion, acoustic reflex threshold 157

reflex criterion, AR screening 180

184

sequence setup 142

service... 145

set time 148

show BBN, acoustic reflex threshold 159 show HBN, acoustic reflex threshold 159 show LBN, acoustic reflex threshold 159

show norm area 152

show xxx Hz, acoustic reflex decay 164

show xxx Hz, acoustic reflex threshold 158

start intensity, acoustic reflex threshold 162

stim output, acoustic reflex threshold 161

stim time, acoustic reflex decay 164

stim time, acoustic reflex threshold 159

stim time, ART 185

188

stim x, acoustic reflex decay 165

stim x, acoustic reflex threshold 160

stimulus side, acoustic reflex decay 165

stimulus side, acoustic reflex screening 154

stimulus, acoustic reflex screening 153

stop when results (are available), screening tympanometry 152

stop when results (are available), tympanometry 151

swap ear data 140

sweep direction 151

sweep direction, ETF-I 152

TPP offset, acoustic reflex decay 163

TPP offset, acoustic reflex threshold 157

tymp auto scale 151

tymp scale 149

use TPP offset, acoustic reflex decay 163

use TPP offset, acoustic reflex threshold 157

users > create user 145 users > delete user 145 users... 145

using setup 138

verification include 162

viewing in OTOsuite 137

Softkeys 23

Acoustic Reflex Screening, screening mode 72

83

84

91

97

General use 23

68

Menu 25

Test Selector 28

tympanometry, automatic mode 76

Specifications, technical 255

Static admittance

description 223

Stimulus

acoustic reflex screening setting 153

intensity increment, acoustic reflex screening setting 155

intensity increment, AR screening setting 181

184

intensity step size, acoustic reflex threshold setting 162

max intensity, acoustic reflex screening setting 155

max intensity, acoustic reflex threshold setting 161

no of intensities, acoustic reflex screening setting 155

output setting, acoustic reflex decay 165

output setting, acoustic reflex threshold 161

post-stim time setting, acoustic reflex decay 164

post-stim time setting, acoustic reflex threshold 160

post-stim time setting, AR 185

post-stim time setting, ART 188

pre-stim time setting, acoustic reflex decay 164

pre-stim time setting, acoustic reflex threshold 159

pre-stim time setting, ART 185

188

266

Otometrics

A B C

D E F G H

I

Index

J K L M N O P

Q R S

T U V

W

X Y Z

setting, acoustic reflex decay 165

setting, acoustic reflex threshold 160

side, acoustic reflex screening setting 154

start intensity, acoustic reflex threshold setting 162

stim time setting, acoustic reflex decay 164

stim time setting, acoustic reflex threshold 159

stim time setting, ART 185

188

Storing 199

Swap ear results 101

Sweep direction

setting 151

setting, ETF-I 152

Switching on device 210

Synchronization of data 103

131

T

Technical specifications 255

Test devices (Immittance)

connecting to 46 firmware update 46 information about 46

Test Selector 27

Testing

Acoustic Reflex 81

Acoustic Reflex Decay 121

Acoustic Reflex Decay, automatic 122

Acoustic Reflex Decay, manual 123

Acoustic Reflex Screening 110

Acoustic Reflex Threshold 114

Acoustic Reflex Threshold, automatic 115

Acoustic Reflex Threshold, manual 119

Diagnostic tympanometry 112

diagnostic tympanometry 80

ETF-I 114

ETF-P 125

leakage 64

Reflex Decay, automatic 92

Reflex Decay, manual 95

97

Reflex Threshold, automatic and semiautomatic 84

Reflex Threshold, manual 88

Screening tympanometry 109

screening tympanometry 71

Text Editor 29

Toynbee’s maneuver 226

TPP

acoustic reflex decay setting 163

acoustic reflex threshold setting 157

ART setting 182

186

description 223

offset, acoustic reflex decay setting 163

offset, acoustic reflex threshold setting 157

offset, ART setting 184

188

Troubleshooting 253

TW

description 224

Tymp scale

tympanometry setting 149

Tympanometric width

description 224

Tympanometry

automatic mode, softkeys 76

basic functions 19

classification system 224

data screen 79

description 222

diagnostic 80

112

ETF-I 114

features 223

layered curves 149

preparing for testing 20

screening 71

109

settings 148

testing infants 222

type, description 224

Tympanometry, screening

settings 152

U

Unpacking 199

User interface 33

Users 60

V

Valsalva’s maneuver 226

View settings

tympanometry 78

Otometrics

267

Index

A B C

D E F G H

I J K L M N O P

Q R S

T U V

W

X Y Z

Views 199

W

Warning notes 217

Wax filter 195

268

Otometrics

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Key Features

  • Wireless interface
  • Standalone device
  • Operable from OTOsuite
  • Integrated with OTOsuite Immittance Module
  • Full test control from device and OTOsuite
  • Comprehensive user interface
  • NOAH compatibility

Frequently Answers and Questions

How does OTOflex 100 connect with OTOsuite?
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.
What are the possible test functionalities of OTOsuite Immittance Module?
The test functionalities of OTOsuite Immittance Module depend on the connected device. It also depends on the selection of test parameters and remote control.
What are some of the key features of OTOflex 100?
OTOflex 100 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.
How can I configure OTOflex 100 for different tests?
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.

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