Otodynamics Otoport OAE+ABR User manual

Otoport OAE+ABR
Otoport NHSP model
Issue 4.4
Otoport OAE+ABR
User Manual for Otoport NHSP model

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 © 2022 Otodynamics Ltd. All Rights Reserved.
User Manual for
Otoport OAE+ABR
Otoport NHSP model
Firmware Revision: 1.19.1.11 onwards
Doc Ref: MANONA - Issue 4.4
: 15/08/2022
1639
Otodynamics Ltd
30-38 Beaconseld Rd
Hateld Herts AL10 8BB UK
MDSS GmbH Schi󰀨graben 41,
30175 Hannover, DE

Contents
Section One General 10
1Before use 11
1.1 Intended use 11
1.2 What do OAEs test for 11
1.3 Otoport setup 12
1.4 Otoport features 12
1.5 Terminology 12
1.6 General use precautions 13
1.7 Contraindications 14
1.8 Safety 14
1.9 The importance of setting the appropriate stimulus levels 16
1.10 Auditory Brainstem Response 17
1.11 Training 18
2 Equipment identication 19
2.1 Supplied only in Otoport NHSP OAE+ABR kit 19
2.2 Supplied only in Otoport NHSP OAE kit 21
2.3 Supplied in both kits 22
2.4 Optional accessories 24
2.5 Controls, indicators and connections 25
2.6 OAE labelling 26
2.7 Otoport OAE+ABR controls, indicators and connections 29
2.8 ABR labelling 30
2.9 Probe cable clip 33
2.10 Probe tips 34

3 Getting started 36
3.1 Connecting probes and sensor cables on the Otoport OAE+ABR 36
3.2 Connecting the probe on the Otoport OAE 38
3.3 Disconnecting the probe 39
3.4 Using the keys and keypad 41
4Test preparation 46
4.1 General checks before testing 46
4.2 Environment checks for ABR 46
4.3 Tip selection and probe tting 47
4.4 Helpful hints 48
4.5 Sensor tting 49
5 Test troubleshooting 52
5.1 OAE test problems 52
5.2 ABR test problems 53
5.3 OAEs and screening 54
Section Two Screeners 55
6 Switch on and Login 56
6.1 Switching on 56
6.2 QA checks reminder 57
6.3 Login 57
7Daily QA checks 59
7.1 Visual Inspection 60
7.2 Probe test 60
7.3 QA tests 65
Contents

8TEOAE test 78
8.1 Entering demographic data 78
8.2 Preparing the baby 79
8.3 Selecting the ear 80
8.4 Checking probe t 80
8.5 Monitoring the test 83
8.6 Test result 84
9ABR test 85
9.1 Impedance check 86
9.2 ABR Checkt 90
9.3 ABR test 92
9.4 ABR test results 94
9.5 Bilateral ABR testing 96
10 Saving tests 98
11 Uploading data to S4H 100
11.1 Downloading from the Otoport 100
11.2 Uploading to S4H 101
12 Maintenance and cleaning 102
12.1 Summary 102
12.2 Probe care 102
12.3 Changing probe coupler tubes 103
12.4 Probe safety note 104
12.5 Otoport care 104
12.6 Use of the Otoport and cleaning 105
Contents
Otoport OAE+ABR
User Manual for Otoport NHSP

13 Otoport power 106
13.1 Battery life 106
13.2 Charging the battery 107
13.3 Conditioning the Otoport battery 108
14 Manufacturer calibration and repairs 109
Section Three Administrators 110
15 Installing Otolink software 111
15.1 Introduction 111
15.2 Minimum PC specications 111
15.3 Installing ILO V6 112
15.4 Otolink CD menu 113
15.5 Install Otolink 114
15.6 Completing Otoport driver installation 116
16 Conguring your Otoport 117
16.1 S4H setup 117
16.2 Login 120
16.3 Site/Facilities 121
16.4 Users 122
16.5 Risks 124
16.6 Probes 125
16.7 Saving conguration to Otoport 126
17 Test setup 127
18 System 129
18.1 System menu 129
18.2 Controls menu 130
18.3 Battery 132
18.4 System details 133
18.5 About 133
Contents

Contents
Otoport OAE+ABR
User Manual for Otoport NHSP
19 Management 134
19.1 Management menu 134
19.2 Users menu 135
19.3 Facility & Risk 136
19.4 Date and time 136
19.5 Other options 137
20 Test details for .....
Local Managers 138
20.1 TEOAE Checkt 138
20.2 TEOAE recording 140
20.3 ABR testing 143
21 Troubleshooting 146
21.1 Otoport lock-up 146
21.2 Switch on 146
21.3 System details 146
21.4 Instrument fault message 147
21.5 Hardware fault messages 148
21.6 Otolink communication problems 148
21.7 Manual driver installation 150
22 Records 155
22.1 Records menu 155
22.2 Patient List 156
22.3 Work list 160
22.4 Database summary 163
23 Downloading Waveforms from S4H 164
23.1 Veiwing downloaded screening data through Otolink 164
2 164

Contents
24 Notes on QA for .....
Local Managers 165
24.1 Probe Test 166
24.2 QA 1 Cavity Test 168
25 Data governance 170
Section Four Technical 174
26 Mode of operation 175
26.1 TE Test 175
26.2 ABR test 177
27 Response detection 182
27.1 OAEs 182
27.2 Condence levels in TEOAE tests 183
27.3 Conclusions 185
28 Technical specications 187
28.1 General 187
28.2 Electromagnetic compatibility - User Guidance 192
28.3 Electromagnetic compatibility - Technical Description 194
28.4 EN60645-3 conformance notes 197
28.5 ABR Module 199
28.6 End of life management 200
28.7 Symbol explanations 201
29 Index 203

Otoport OAE+ABR
User Manual for Otoport NHSP
9

Section One General
10

1Before use
1.1 Intended use
This Otodynamics Otoport 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. 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.
Where the individual to be screened is healthy with no medical conditions
related to the ear, as in the case of well-baby hearing screening, the
user can be a trained screener. In all other cases the user should be an
audiologist or medical professional.
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.
1.2 What do OAEs test for
• OAEs test for problems in the peripheral auditory system. It is important
to remember that OAEs do not test the whole hearing system, only
cochlear function.
• Absence of OAE can be due to cochlear or middle ear dysfunction.
Failure to detect any OAEs can also be due to high levels of noise or a
blocked or badly tted probe.
• The presence of OAEs indicates good middle ear function and good
transmission of stimulation by outer hair cells inside the cochlea, at the
tested frequency.
Before use
Otoport OAE+ABR
User Manual for Otoport NHSP
11

• Good OAEs do not exclude the possibility of auditory neuropathy or
higher neural dysfunctions but these higher level dysfunctions are almost
unknown in the well baby population. This is why OAEs have been used
as an e󰀨ective primary screen in hearing screening programmes for
decades in many countries.
• Higher level disorders are occasionally present in ‘at risk’ and
NICU babies and for this reason both OAE and ABR screening is
recommended for this group.
1.3 Otoport setup
Before your Otoport can be used for testing, it must be congured with
information supplied automatically from S4H.
After fully charging the Otoport, follow instructions in chapter 4Installing
Otolink software and chapter 5Conguring your Otoport.
Note:
It will not be possible to transfer to S4H test results recorded
before the Otoport has been congured.
1.4 Otoport features
The Otoport provides high quality OAE and ABR measurement features in
a compact, handheld format.
The Otoport is simple to use and with powerful measurement features
performs an automatic analysis of cochlear status within seconds. Set
NHSP pass criteria control the test’s automatic stop mechanism. NHSP
specic test outcomes are then clearly reported.
This Otoport has been specially congured for use in the NHS Newborn
Hearing Screening Programme.
1.5 Terminology
In line with NHSP family friendly practice, wherever suitable the probe
should be referred to as the earpiece and electrodes should be referred to
as sensors. The terms are used interchangeably in this manual.
For AOAE (Automated OAE) test the Otoport uses TEOAE (Transient
Evoked Otoacoustic Emissions).
Before use
CHAPTER TWO
Before use
12

1.6 General use precautions
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 daily to
conrm the system continues to operate e󰀨ectively.
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.
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 and dry and also to establish that there
are no contraindications to carrying out the test (see section 1.7
Contraindications).
TRAINING
REQUIRED
Before use
Otoport OAE+ABR
User Manual for Otoport NHSP
13

If the ear is not clean and dry 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.
1.7 Contraindications
This device should not be used for testing if there is discharge from the test
ear, occlusion of the external auditory meatus by wax or other material,or if
there is severe otitis externa.
Testing should also not be performed in the case of deformity of, or surgery
to the ear or ear canal which might prevent the probe being comfortably
tted or acoustical sealed into the ear canal, unless examined and
permitted by an audiologist or doctor.
1.8 Safety
Caution
Connection of a patient to a high frequency (HF) surgical equipment and to
the instrument in ABR mode simultaneously may result in burns at the site
of the electrodes and possible damage to the instrument.
The Otoport should not be operated in close proximity to shortwave or
microwave therapy equipment.
When one or more ABR electrodes are connected to the patient, take care
to avoid any contact between the remaining electrodes and any conductive
surfaces, such as other equipment. Failure to observe this precaution may
result in harmful electrical currents owing through the patient.
Before use
CHAPTER TWO
Before use
14

The ABR skin impedance measurement (via stimulation) function is
not intended for trans-thoracic use – follow our guidance on electrode
placement.
The Otoport should not be used on a patient with an implanted electronic
device unless specialist medical opinion has rst been obtained.
Anyone who combines charging devices, software, and IT equipment for
use with the instrument congures a Medical System, and is therefore
responsible for ensuring that the system complies with the safety
requirements of the IEC 60601-1 standard.
Otodynamics Ltd. only selects materials for use in its instruments and
accessories that have a proven track record of safe use in medical devices.
All materials used in the manufacture of the Otoport and applied parts meet
the biocompatibility requirements of ISO 10993; in consideration of the
likely nature and duration of contact of each material with both patient and
user.
This device should be used only with the leads, electrodes, probes, ear
cups and accessories recommended for use by Otodynamics Ltd. which
will comply with medical device Biocompatibility/ Safety Standards (EN ISO
10993/ EN 60601-1).
Infants and children should not be left unattended with the Otoport or its
accessories.
The Otoport instrument is not protected against liquid ingress (rating IPx0) -
do not allow liquid to enter the instrument.
When connecting the Otoport with PCs, printers and servers a secured
user network is required.
Observe good Information security management practices per EN ISO/IEC
27001 standard.
If in any doubt, or if further guidance is required, contact Otodynamics or
your dealer for support.
Before use
Otoport OAE+ABR
User Manual for Otoport NHSP
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1.9 The importance of setting the appropriate
stimulus levels
The correct stimulus setting is vital for e󰀨ective hearing screening with
OAEs and ABR. The optimum stimulus level for your screening programme
will be one that identies the vast majority of infants with abnormal ears,
but only rarely wrongly reports a healthy normal ear as needing to be
referred.
Screening programs di󰀨er in their requirement to detect slight losses, and
in their capacity to deal with false positives.
Over the decades in which TEOAE have been studied and used for
newborn screening, a click stimulus level of ‘84dBpe’ in the ear has been
proved e󰀨ective and e󰀩cient, and become the de facto standard for
TEOAE screening. The parameter ‘84dBpe’ indicates the peak sound
pressure level of the brief click stimulus. It does not represent the hearing
level or sensation level.
For DPOAE screening stimulus levels L1/L2 of 65/55dBSPL are most
widely used and recommended in the literature as both sensitive to mild
losses and as eliciting a robust response from normal ears. This stimulus
decibel level does not indicative of the hearing level of the stimuli or the
sensitivity to hearing loss.
Unlike for TEOAE and DPOAE the stimulus level for ABR screening is
expressed relative to the threshold of hearing for healthy ears (indicated
by ‘dBHL). The stimulus dBHL must calibrated on a group of healthy young
ears using the specic stimulus format actually delivered by the instrument.
It has to be determined experimentally for each instrument and stimulus
type. For ABR screening the stimulus level setting is made somewhat
higher than the normal threshold level. This is to ensure that normal healthy
responses are recordable in a reasonably short time and that the test is
only sensitive to clinically signicant losses.
Otoport ABR stimulus settings of both 35 and 40dBHL are widely used for
newborn screening. The 35dBHl setting gives exceptional sensitivity to
slight losses with a somewhat lower specicity than the 40dBHL setting.
The 40dBHL setting gives excellent sensitivity to mild losses and higher
specicity i.e., there are fewer false positives. Stimulus levels outside of
this range are not recommended for regular screening.
Note that the Otoport ABR is not intended for use in diagnostic use. In
clinical testing with OAEs a wider range .
Before use
CHAPTER TWO
Before use
16

Never over-stimulate for infant screening.
Over-stimulation will result in mild and some moderate hearing losses
being missed.
TEOAEs - never use stimulus levels above 87dBpe for screening,
DPOAEs - never use stimulus level of 70dBSPL or above for screening
AABR - never use stimulus level above 45dBHL for screening.
1.10 Auditory Brainstem Response
Auditory Brainstem Response (ABR) is an electrophysiologic response
that measures the auditory system’s response to sound. Three sensors
are placed on the patient and a probe connected to an earcup is placed on
the test ear. The equipment sends a soft clicking sound to the ears and the
sensors pick up the nerve’s response to that sound.
The cochlea or 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. These electrical responses are commonly
known as auditory evoked potentials. One type of auditory evoked potential
is the Auditory Brainstem Response, which occurs within approximately
3-20 ms of the onset of the stimulus (depending on frequency and intensity
of the stimulus). Voltages (potentials) can be measured at the skin with
surface sensors; the sensor montage consisting of three such sensors.
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 enhanced
by averaging. The amplitude of the ABR is also quite small compared
to voltages generated by myogenic (muscle) activity; therefore, ideally,
children should be tested when sleeping. The ABR consists of a series of
positive waves (at the vertex of the scalp) that are named by their relative
order (waves I through V). ABR is typically elicited by click, brief tone, or
chirp stimuli.
If EEG and myogenic artefacts are below a tolerable (noise reject) level,
the Otoport ABR rmware will detect the ABR waves and give a simple
Pass/Fail response to the user. The resultant waveforms may also be
viewed, and results interpreted, manually if so desired.
Before use
Otoport OAE+ABR
User Manual for Otoport NHSP
17

1.11 Training
TRAINING
REQUIRED
It is important that the operator of the Otoport is properly trained before
using the instrument. The manual should be read before use and note
taken of the sections marked with the training required symbol.
Where the training symbol is directly beneath a chapter title, it indicates
that training is required for everything within the chapter. Where the symbol
appears beneath a section heading, it indicates that training is required for
that section only.
Where the device is to be used for other than the screening of healthy
individuals, the user must be competent in the recognition of medical
conditions associated with ears which may preclude testing (see
Contraindications). Training for that purpose must be given by an
audiologist or medical professional.
In all cases before application of the probe to the ear there must be an
appropriate visual examination of the ear as specied by an audiologist or
medical professional as part of training.
Training in operating the device is provided by Otodynamics Ltd in the UK.
Training in the operation of the device elsewhere is via an approved dealer
who has been trained by Otodynamics. Training on OAEs and use of the
equipment may also be provided by previously trained sta󰀨 and qualied
audiologists.
Ensure your local policy for infection control is followed, as well as reading
the recommendations in this manual (see section 12.6 Use of the Otoport
and cleaning).
If a problem occurs during the operation of your Otoport or Otolink software
or a message or warning appears that you don’t understand, make note of
the issue and messages provided. Refer these to Otodynamics for support.
Before use
CHAPTER TWO
Before use
18

19
2 Equipment identication
2.1 Supplied only in Otoport NHSP OAE+ABR
kit
REF NHSP-OS-ST+ABR
Otoport NHSP OAE+ABR
REF NHSP-PR-ABRLS
UGS TEOAE Serviceable
probe for binaural use (BLUE)
1 meter cable
REF NHSP-PR-ABRRS
UGS TEOAE Serviceable
probe for binaural use (RED)
1 meter cable
REF ABR-INF
Infection control sleeve for
Otoport OAE+ABR unit only
Equipment identication
Otoport OAE+ABR
User Manual for Otoport NHSP

CHAPTER TWO
Equipment identication
20
REF NHSP-ABR-CAV
Probe cavity and
ABR cable tester
REF BGSR
RED BGS probe body and lid
x 1
Supplied with Otoport NHSP
Re-order quantity: 10
REF BGSL
BLUE BGS probe body and lid
x 1
Supplied with Otoport NHSP
Re-order quantity: 10
REF ABR-E-TAB
ABR Tab Electrodes x 1
pack of 3
Re-order quantity: 60
ABR Starter kit
REF ABR-CUP
ABR Ear Cups, 2x pairs
Re-order quantity: 20 pairs
REF NHSP-ABR-DS
ABR Desktop stand / Crib hook
Desktop stand / crib hook insert for ABR
sleeve.
Equipment identication