Otodynamics Otoport OAE+ABR User manual

Otoport OAE+ABR
Otoport Lite model
Issue 4
Otoport OAE+ABR
User Manual for Otoport Lite model

CHAPTER ONE
Introduction
2
Introduction
User Manual for
Otoport OAE+ABR
Otoport Lite model
Issue 4 : January 2017
Firmware Revision 3.26.1.16 onwards
Doc Ref: MANABR2-7.4
Copyright Notice
No part of this publication may be copied by any means,
translated or distributed to third parties without the express
written permission of Otodynamics Ltd.
Copyright © 2017 Otodynamics Ltd. All Rights Reserved.
Otodynamics Ltd
30-38 Beaconseld Rd
Hateld Herts AL10 8BB UK
0120

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Introduction
Contents
1Introduction 10
1.1 Intended Use 10
1.2 General guidance 11
1.3 General use precautions 12
1.4 Types of otoacoustic emissions 14
1.5 OAEs and screening 15
1.6 Auditory Brainstem Response 16
2 Equipment identication 17
2.1 Supplied only in Otoport OAE+ABR kit: 17
2.2 Supplied only in Otoport Lite kit: 18
2.3 Supplied in both kits: 19
2.4 Optional accessories 22
2.5 Otoport controls, indicators and connections 24
2.6 Scanner 25
2.7 OAE labelling 26
2.8 Otoport OAE+ABR controls, indicators and connections 28
2.9 ABR labelling 29
3Getting started 31
3.1 Assembling the ABR Module with an Otoport 31
3.2 Removing the Otoport from the ABR Module 34
3.3 Otoport OAE+ABR with non-removable module 34
3.4 Connecting probes and electrodes 35
3.5 Initial charge 37
3.6 Using the Otoport keys and keypad 37
3.7 Connecting the probe to the Otoport 41
3.8 Disconnecting the probe from the Otoport 42

CHAPTER ONE
Introduction
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Introduction

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Introduction
4Switching On 44
4.1 Switch on screen 44
4.2 Logo screen 45
4.3 Login 46
4.4 Main menu 47
5Test preparation 48
5.1 General checks before testing 48
5.2 Environment checks for ABR 48
5.3 Tip selection and probe tting 49
5.4 Electrode tting 51
6Test troubleshooting 54
6.1 OAE test problems 54
6.2 ABR test problems 55
7OAE test procedure 57
7.1 Checkt 58
7.2 TE test (TEOAE model) 60
7.3 DP test (DPOAE model) 67
7.4 Quick Save option 72
7.5 Review 74
7.6 Save 75
7.7 Final review 77
7.8 Last 78
7.9 Result 80
8ABR test 81
8.1 Impedance check 82
8.2 Checkt 86
8.4 ABR test 87

CHAPTER ONE
Introduction
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Introduction

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User Manual for Otoport Lite model
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Introduction
9Worklist 94
9.1 Adding Patients 94
9.2 Testing from the Worklist 95
9.3 Editing details 95
9.4 Deleting patients 96
10 Records 97
10.1 Patient list 98
11 Conguration 102
11.1 Conguration menu 102
11.2 Quality tests 103
11.3 Test settings 103
11.4 Date and time 115
11.5 System 116
11.6 Users 122
12 Printing and downloading 125
12.1 Bluetooth wireless printing and download 125
12.2 Wired downloading 126
12.3 When you can print 127
12.4 The printing process 131
12.5 Printer fault detection 133
12.6 Printer light summary 133
12.7 Paper 134
12.8 Charging the printer 135
12.9 Changing the battery 136
13 Scanning 137
13.1 Scanning facility 137
13.2 Scanner types 137
13.3 When to use the scanners 139

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Introduction
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Introduction
14 Quality tests 141
14.1 Probe test 141
14.2 ABR cable test 146
14.3 Cavity test 147
14.4 Occlusion test 148
14.5 Real ear test 149
15 Probe, tips and accessories 150
15.1 Probe and service accessories 150
15.2 Probe cable clip 150
15.3 Probe tips 152
16 Probe care 155
16.1 Cleaning 155
16.2 Changing probe coupler tubes 155
16.3 Probes safety note 157
17 Care of the Otoport 158
17.1 Use of the Otoport and cleaning 158
18 Power 160
18.1 Battery life 160
18.2 Initial charge 160
18.3 Standby 161
18.4 Battery charge 162
18.5 Charging the Otoport 164
18.6 Conditioning the Otoport battery 167
18.7 Additional battery care 168
18.8 Otoport OAE+ABR 168

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19 Equipment troubleshooting 169
19.1 Otoport lock-up 169
19.2 Switch on 169
19.3 System details 169
19.4 Instrument fault message 170
19.5 Hardware fault messages 171
20 Training 172
21 Obtaining service 173
22 Calibration 174
23 Mode of operation 175
23.1 TEOAE model 175
23.2 DPOAE model 177
23.3 ABR test 178
24 Technical specications 184
24.1 Otoport 184
24.2 Electromagnetic Compatibility: Otoport 188
24.3 Electromagnetic Compatibility: Otoport OAE+ABR 193
24.4 EN60645-3 conformance notes 199
24.5 ABR Module 201
24.6 Symbol explanations 202
25 Index 204

CHAPTER ONE
Introduction
10
Introduction
1Introduction
This manual provides instructions for use for two compact, handheld
instruments, the Otoport OAE+ABR (Otoport Lite model) and the Otoport
Lite OAE system.
1.1 Intended Use
This Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use
when there is a requirement to screen for hearing disorders by objective
and non-invasive means. ABR, TEOAE and DPOAE screening test
results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is
presented to the user who will be a trained screener, audiologist or medical
professional. Use of the device is indicated when the patient is unable
to give reliable voluntary responses to sound, especially with infants.
Use of the device facilitates the early detection of hearing loss and its
characterization.
The TEOAE and DPOAE analytical functions of the device are
indicated when objective non-invasive clinical investigations require the
characterization and monitoring of the functional status of the peripheral
auditory function. For this purpose the device is intended to be used by
audiologists or other audiologically skilled professionals. These TEOAE
and DPOAE tests are applicable to populations of any age to obtain
objective evidence of peripheral auditory function.

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Introduction
1.2 General guidance
Each test type provides evidence of normal peripheral hearing function
objectively and non-invasively.
The screening functions of this instrument are especially suitable for
use with infants. The ABR screening function uses conventional Fsp
methodology to detect the response supported by waveform identication
(Template Correlation) which is optimised for infants from 34 weeks to
6 months gestational age. Template-free pass criteria for ABR may be
selected for use with patients outside this age range (see chapter 11
Conguration, section 11.3.4 Pass criteria). OAE screening functions
include Otodynamics classic Quickscreen TEOAE technology and Rapid
DPOAE technology (depending on the model).
The device can be used in a wide range of di󰀨erent environments for
example in the well-baby nursery, the NICU, a doctor’s o󰀩ce, an audiology
clinic, the outpatient clinic or in the home. For optimum results and short
test times the room should be quiet and the patient should be very quiet
and still during the test. The device will clearly indicate levels of acoustic
noise and electrical interference (with ABR). Use this as a guide to improve
the testing environment.
The screening functions of the device are intuitive and suitable for
operation by trained screeners without specialized knowledge. Testing and
interpretation is automated. The TEOAE and DPOAE analysis functions
of the device are intended for clinical audiological investigations when
objective non-invasive characterisation and monitoring of the functional
status of the peripheral auditory function is required. These functions
are intended for use as a part of the audiological diagnostic test battery,
not as solitary diagnostic tests. The OAE analysis functions provided on
some models are of particular interest to Audiologists, Ear, Nose and
Throat specialists, Neurology specialists, researchers and other health
professionals concerned with the di󰀨erential diagnosis of hearing problems,
the monitoring of changes to hearing, the conservation of hearing or the
detailed measuring peripheral auditory function.

CHAPTER ONE
Introduction
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Introduction
1.3 General use precautions
The Otoport pass criteria are set in the Conguration area (see chapter 8
Conguration). It is the responsibility of the user to ensure that the pass
criteria set meet their requirements.
Measuring OAEs and ABRs requires that the ear is exposed to sound.
Whilst the level of this exposure is harmless under normal test conditions,
it is not recommended that tests be allowed to continue indenitely even if
there is no result.
The Otoport includes ‘stop criteria’ which will automatically terminate the
test when an OAE or ABR pass has been achieved or after ve minutes.
Whilst this limits the sound exposure in a single test, the user is responsible
for limiting the number of separate tests performed on the same ear.
The Otoport has built in signal analysis proven to distinguish true OAEs
and ABRs from artefactal signals. Checks should be performed weekly
and before each test session to conrm the system continues to operate
e󰀨ectively (see chapter 14 Quality checks).
In exceptional circumstances, either an equipment fault or failure to comply
fully with the instructions in this manual may result in unreliable test results.
Results with total OAE responses greater than 40 dB SPL should be
considered highly suspect and should not be relied on.
The probe’s coupler tubes which carry sound to and from the ear canal
are protected from contamination by the disposable tip. The probe should
never be inserted into the ear without a disposable tip attached. Doing so
risks damage to the ear by the probe body and contamination of the probe
by the ear.
If contamination occurs the coupler tubes must be replaced (see 16.2
Changing probe coupler tubes).
TRAINING
REQUIRED

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Introduction
Visually inspect the coupler tubes before use. A blocked sound delivery
tube may prevent the Otoport from achieving its target stimulation level and
so prevent testing. It may also attenuate certain frequencies and limit the
number of pass bands. A blocked microphone tube will prevent the Otoport
from sensing the stimulus level in the ear and from detecting the OAE. As
a result the Otoport may apply a louder than normal sound to the ear.
All surfaces of the Otoport may be cleaned with an alcohol based wipe or
cloth with antiseptic uid. Dry the device immediately with tissue.
Do not allow liquid to enter the instrument.
If additional hygienic protection is required, clear plastic infection control
sleeves designed to contain the Otoport during use are available from
Otodynamics.

CHAPTER ONE
Introduction
14
Introduction
1.4 Types of otoacoustic emissions
Otoacoustic emissions are sounds which can be recorded in the ear canals
of functionally normal ears.
This Otoport can make two types of OAE measurements: Transient Evoked
OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs).
The di󰀨erence between the measurements is largely in the means used
to generate and measure the emission, rather than in the source of the
emission itself.
TEOAEs use a click to briey stimulate the cochlea across a wide
frequency range and record the response from the cochlea.
DPOAEs use a pair of pure tones of specic frequencies (f1 and f2) to
stimulate the cochlea and record the distortion generated by the tones
in the cochlea at a third frequency (2f1-f2). Di󰀨erent pairs of f1 an f2
frequencies are used in turn to acquire emissions from di󰀨erent areas
along the length of the cochlea.
The two measurement techniques have di󰀨erent characteristics and so
lend themselves to di󰀨erent uses, for example:
TEOAE are rapidly acquired, sensitive to small hearing losses and
stimulate the cochlea broadly across the frequency range required for
speech and language development. These properties have meant that
TEOAE have been widely used in newborn hearing screening programmes.
DPOAE allow testing at higher frequencies and allow emissions to be
measured in patients with moderate hearing losses. These properties have
lead to their use in recording OAEs in older patients who may have mild
hearing losses.
Other applications may benet from the use of a combination of both tests
and a range of stimulus levels.

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Introduction
1.5 OAEs and screening
OAE testing is commonly used as the primary hearing screen in newborns
with no known hearing loss risk factors. Failure to show a strong OAE
indicates that further testing or observation is necessary.
OAE testing is frequently used as the initial screen within the ‘at risk’
population. Passing the OAE test indicates that normal middle ear and
cochlear function is present. The specic risks must be evaluated to
determine whether ABR (auditory brainstem response) testing is necessary,
even after a pass at OAE. Certain clinical conditions indicate the possibility
of retro-cochlear/neurological disorders which the OAE test cannot detect.

CHAPTER ONE
Introduction
CHAPTER ONE
Introduction
16
Introduction
1.6 Auditory Brainstem Response
Auditory Brainstem Response (ABR) is an electrophysiological response
that measures the auditory system’s response to sound. Three voltage
sensors (electrodes) are placed on the patient and a sound probe is placed
in the test ear. The equipment sends a click, brief tone, or chirp sound
stimuli to the test ear.
The cochlea (inner ear) converts sound into electrical signal. These signals
travel in sequence to the acoustic nerve, the brainstem, and nally to
the cortical areas of the brain. The electrodes pick up these electrical
responses to the sound which are commonly known as auditory evoked
potentials. A response which occurs within 20ms of the onset of the
stimulus is referred to as an Auditory Brainstem Responses (ABR).
As the amplitude of the ABR is very small compared to the ‘noise’ of other
brain electrical activity (EEG) the ‘signal to noise ratio’ is very poor. It is
enhanced by a process called averaging. The amplitude of the ABR is also
quite small compared to voltages generated by myogenic (muscle) activity;
therefore, ideally, patients should be tested when sleeping or when very
still.
If EEG and myogenic artefacts are below a tolerable (noise reject) level,
the Otoport ABR rmware will detect the ABR and automatically give a
simple Pass/Fail response to the user. Other details of the test including
the ABR waveforms may also be viewed, and results interpreted, manually
if so desired.

Otoport OAE+ABR
User Manual for Otoport Lite model
Equipment identication
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2Equipment identication
2.1 Supplied only in Otoport OAE+ABR kit:
Otoport Lite OAE+ABR
REF ABR-EC1
Electrode cables - 1m
REF ABR-EC2
Electrode cables - 2m
REF ABR-SK
Starter kit of electrodes,
skin preparation gel and
pack of cotton wool pads
REF LTC-ST+ABR (TEOAE model) or
LTC-SD+ABR (DPOAE model)

CHAPTER TWO
Equipment identication
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Equipment identication
REF ABR-INF
Infection control sleeve for
Otoport OAE+ABR unit only
Shown tted
REF ABR-CAS
Equipment case for
Otoport OAE+ABR kit
2.2 Supplied only in Otoport Lite kit:
REF LTC-ST or LTC-SD
Otoport Lite
REF OP-CAS
Equipment case for Otoport
Lite kit
REF ABR-CAV
Probe cavity and
ABR cable tester

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Equipment identication
19
REF PR-CLIP
Probe cable clip
REF PR-POUCH
Drawstring probe pouch
REF PR-UGS
UGS TEOAE probe
Supplied with TEOAE model
REF PR-UGD
UGD DPOAE probe
Supplied with DPOAE model
2.3 Supplied in both kits:
REF OAE-CAV
Probe test cavity

CHAPTER TWO
Equipment identication
20
Equipment identication
REF TPC
TPC probe coupler tubes x 5
Supplied with TEOAE probe
Re-order quantity: 10 or 100
REF DPC
DPC probe coupler tubes x 5
Supplied with DPOAE probe
Re-order quantity: 10 or 100
REF BGS
BGS probe body and lid x 1
Supplied with TEOAE probe
Re-order quantity: 10
REF BGD
BGD probe body and lid x 1
Supplied with DPOAE probe
Re-order quantity: 10
Sample probe tips
See chapter 15
Probe, tips and accessories
for re-order codes