Otodynamics DP Clinical User manual

Otoport OAE+ABR
User Manual for Otoport DP+TE models
Including: DP Clinical, DP Clinical Flexi, DP+TE and Otoport Flexi
Otoport OAE+ABR
Otoport DP+TE models
Issue 5

2
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
User Manual for
Otoport OAE+ABR
Otoport DP+TE models
Including: DP Clinical, DP Clinical Flexi,
DP+TE and Otoport Flexi
Issue 5 : August 2017
Firmware revision 3.27.1.40 onward
Doc Ref: MANABR3-7.1

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Contents
1Introduction 9
1.1 Intended use 9
1.2 General guidance 10
1.3 General use precautions 11
1.4 Types of otoacoustic emissions 13
1.5 OAEs and screening 14
1.6 Auditory Brainstem Response 15
2 Equipment identication 16
2.1 Supplied only in Otoport OAE+ABR kit 16
2.2 Supplied only in Otoport DP+TE kit 17
2.3 Supplied in both kits 18
2.4 Optional accessories 21
2.5 Controls, indicators and connections 23
2.6 OAE labelling 24
2.7 Otoport OAE+ABR controls, indicators and connections 26
2.8 ABR labelling 27
3 Getting started 29
3.1 Assembling the ABR Module with an Otoport 29
3.2 Removing the Otoport from the ABR Module 32
3.3 Otoport OAE+ABR with non-removable module 32
3.4 Connecting probes and electrodes 33
3.5 Initial charge 35
3.6 Quickstart guides 35
3.7 Using the keys and keypad 39
3.8 Connecting the probe to the Otoport 43
3.9 Disconnecting the probe 44

4
4 Switching On 46
4.1 Switch on screen 46
4.2 Logo screen 47
4.3 Mode select 48
4.4 Login 49
4.5 Test choice 50
5 Test preparation 52
5.1 General checks before testing 52
5.2 Environment checks for ABR 52
5.3 Tip selection and probe tting 53
5.4 Electrode tting 55
6Test troubleshooting 58
6.1 OAE test problems 58
6.2 ABR test problems 59
7 Test selection 61
7.1 Choose test type or worklist 61
7.2 Patient details 63
7.3 Select test ear 64
7.4 Checkt 65
8DPOAE test 68
8.1 DP stimulus calibration 68
8.2 DP test screen 69
8.3 Test stop reasons 74
8.4 DPOAE test results 75
9TEOAE test 76
9.1 TE stimulus adjustment 76
9.2 TEOAE test screen 77
9.3 Test stop reasons 81
9.4 TEOAE test results 83

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10 ABR test 84
10.1 Impedance check 85
10.2 Checkt 89
10.3 Ear cup Checkt 89
10.4 ABR test 90
10.5 Bilateral ABR testing 97
11 Saving the test 99
11.1 Quick Save option 99
11.2 Patient details 101
11.3 Review 102
11.4 Last 103
11.5 Result 105
12 Link-Test 106
13 Work List 107
13.1 Adding Patients 107
13.2 Editing details 108
13.3 Deleting Patients 109
13.4 Testing from the Work List 109
14 Utilities 110
14.1 Patients tested 111
14.2 Patient details 112
14.3 Summary results 113
14.4 Detailed results 115
15 Conguration 116
15.1 Quality tests 116
15.2 Test settings 117
15.3 Date and time 135
15.4 System 136
15.5 Users 143

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16 Printing and downloading 146
16.1 Bluetooth wireless printing and download 146
16.2 Wired downloading 147
16.3 When you can print 148
16.4 The printing process 152
16.5 Printer fault detection 154
16.6 Printer light summary 155
16.7 Paper 156
16.8 Charging the printer 157
16.9 Changing the battery 158
17 Quality tests 159
17.1 Probe test 159
17.2 ABR cable test 165
17.3 Cavity test 166
17.4 Occlusion test 167
17.5 Real ear test 168
18 Probe, tips and accessories 169
18.1 Probe and service accessories 169
18.2 Probe cable clip 169
18.3 DPOAE+TEOAE probe tips 171
19 Probe care 173
19.1 Cleaning 173
19.2 Changing probe coupler tubes 173
19.3 Probes safety note 175
20 Care of the Otoport 176
20.1 Use of the Otoport and cleaning 176

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21 Power 178
21.1 Battery life 178
21.2 Initial charge 178
21.3 Standby 179
21.4 Battery charge 180
21.5 Charging the Otoport 182
21.6 Conditioning the Otoport battery 185
21.7 Otoport OAE+ABR 186
22 Equipment troubleshooting 187
22.1 Otoport lock-up 187
22.2 Switch on 187
22.3 System details 187
22.4 Instrument fault message 188
22.5 Hardware fault messages 189
23 Training 190
24 Obtaining service 191
25 Calibration 192
26 Mode of operation 193
26.1 DPOAE test 193
26.2 TEOAE test 194
26.3 ABR test 196
27 Technical specications 202
27.1 Otoport 202
27.2 Electromagnetic Compatibility: Otoport 206
27.3 Electromagnetic Compatibility: Otoport OAE+ABR 211
27.4 EN60645-3 conformance notes 217
27.5 ABR Module 219
27.6 Symbol explanations 220
28 Index 223

8

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Introduction
1Introduction
This manual provides instructions for use for two compact, handheld
instruments, the Otoport OAE+ABR (Otoport DP+TE models) and the
Otoport DP+TE OAE system. This includes DP Clinical, DP Clinical Flexi,
DP+TE and Otoport Flexi variants.
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.

CHAPTER ONE
Introduction
10
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 15
Conguration, section 15.2.4 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.

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Introduction
1.3 General use precautions
Do not connect the patient to high frequency (HF) surgical equipment
and to an Otoport in ABR mode simultaneously. Failure to observe this
precaution may result in burns at the site of the electrodes and possible
damage to the Otoport.
When one or more ABR electrodes are connected to the patient take care
to avoid any contact between the remaining electrodes and conductive
surfaces, such as other equipment. Failure to observe this precaution my
result in harmful electrical currents owing through the patient.
The Otoport pass criteria are set in the Conguration area (see chapter 15
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 within ten 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 17 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.
TRAINING
REQUIRED

CHAPTER ONE
Introduction
12
Introduction
If contamination occurs the coupler tubes must be replaced (see section
19.2 Changing probe coupler tubes).
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.
Before inserting the probe, the ear should be inspected to ensure that
the ear canal is clean. If this precaution is not taken, the probe may be
damaged. This misuse is not covered by warranty.
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.
Otodynamics does not guarantee the accuracy of the test results or the
tests themselves, if accessories other than those supplied by Otodynamics
are used.

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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.

CHAPTER ONE
Introduction
14
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.

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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.

CHAPTER TWO
Equipment identication
16
Equipment identication
2 Equipment identication
2.1 Supplied only in Otoport OAE+ABR kit
REF DTC+ABR
Otoport DP+TE OAE+ABR
REF ABR-EC1
Electrode cables - 1m
REF ABR-EC2
Electrode cables - 2m
REF ABR-SK
Starter kit of electrodes pack,
skin preparation gel and pack of
cotton wool pads

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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 DP+TE kit
REF DTC-S
Otoport DP+TE
REF OP-CAS
Equipment case for Otoport
DP+TE kit
REF ABR-CAV
Probe cavity and
ABR cable tester

CHAPTER TWO
Equipment identication
18
Equipment identication
REF PR-CLIP
Probe cable clip
REF PR-POUCH
Drawstring probe pouch
REF PR-UGD
UGD DPOAE probe
2.3 Supplied in both kits
REF OAE-CAV
Probe test cavity

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Equipment identication
REF DPC
DPC probe coupler tubes x 5
Re-order quantity: 10 or 100
REF BGD
BGD probe body and lid x 1
Re-order quantity: 10
REF DP-BOX
Sample probe tips
See chapter 18
Probe, tips and accessories
for re-order codes
REF OP-CHG
Charger and mains lead
REF OP-CAB
PC downoad cable

CHAPTER TWO
Equipment identication
20
Equipment identication
REF OTOLINK
Otolink software CD
REF OP-INF
Infection control sleeve for
Otoport only
Shown tted
Documentation pack
Includes instrument and software
manuals, quickstart and probe use
guides