Interacoustics Sera Installation manual

D-0114042-D– 2020/03
Science made smarter
Additional Information
Sera™

Table of contents
About the Additional Information manual ........................................................................................ 1
Warnings........................................................................................................................................ 1
List of abbreviations ........................................................................................................................... 3
Battery life ............................................................................................................................................ 5
Disposables ......................................................................................................................................... 7
Ear tips........................................................................................................................................... 7
Tips for use of the Sanibel disposable tab and snap electrodes ................................................... 8
Sensitivity and specificity .................................................................................................................. 9
What is sensitivity and specificity? ................................................................................................ 9
Preparing for the screening test ...................................................................................................... 11
Acoustical noise........................................................................................................................... 11
Electrical noise & Automated ABR .............................................................................................. 11
OAE probe test ............................................................................................................................ 12
Automated ABR patient preparation............................................................................................ 12
6.4.1 General information ................................................................................................... 12
6.4.2 Skin preparation......................................................................................................... 12
6.4.3 Electrode preparation sites for the nape montage .................................................... 13
6.4.4 Electrode placement for the nape montage............................................................... 13
6.4.5 Preamplifier cable connections.................................................................................. 14
6.4.6 Place transducers ...................................................................................................... 14
6.4.7 Insert earphones with EarCups ................................................................................. 14
6.4.8 Insert earphones with ear tips.................................................................................... 15
6.4.9 Probe ......................................................................................................................... 16
OAE patient preparation .............................................................................................................. 16
6.5.1 General information ................................................................................................... 16
6.5.2 Place transducer........................................................................................................ 17
ABRIS ................................................................................................................................................. 19
About the ABRIS module............................................................................................................. 19
Automated ABR testing ............................................................................................................... 19
Automated ABR with Sera™ ....................................................................................................... 19
Electrode impedance measurement technique ........................................................................... 20
Electrode impedance check with SeraTM ..................................................................................... 21
Transducer information area in SeraTM........................................................................................ 21
Automated ABR protocols ........................................................................................................... 22
Explanation of protocol parameters............................................................................................. 22
DPOAE................................................................................................................................................ 25
About the DPOAE module ........................................................................................................... 25
DPOAE testing............................................................................................................................. 25
Automated DPOAE with Sera™ .................................................................................................. 25
DPOAE protocols......................................................................................................................... 26
Explanation of protocol parameters............................................................................................. 28
TEOAE ................................................................................................................................................ 29
About the TEOAE module ........................................................................................................... 29
TEOAE testing ............................................................................................................................. 29
Automated TEOAE with SeraTM................................................................................................... 29
TEOAE protocols ......................................................................................................................... 30
Explanation of protocol parameters............................................................................................. 32

HearSIMTM software application....................................................................................................... 33
Cleaning and disinfection................................................................................................................. 35
General information about cleaning and disinfection .................................................................. 35
Caution during cleaning and disinfection..................................................................................... 35
SeraTM hardware device .............................................................................................................. 35
11.3.1 Cleaning the touch screen ......................................................................................... 36
Cradle .......................................................................................................................................... 36
Preamplifier and electrode lead wires ......................................................................................... 36
Insert phone cable ....................................................................................................................... 37
EarCup and ear tip adapters ....................................................................................................... 37
Probe ........................................................................................................................................... 37
11.8.1 Cleaning the probe tip................................................................................................ 38
Disposables ................................................................................................................................. 40
Accessories/replacement parts ................................................................................................... 40
SeraTM ABRIS Pass-Checker (optional) ...................................................................................... 40
FAQ/Troubleshooting........................................................................................................................ 41
Hardware ..................................................................................................................................... 41
Firmware...................................................................................................................................... 42
Optional SeraTM ABRIS pass-checker ......................................................................................... 46

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About the Additional Information manual
The Additional Information manual provides a more detailed overview of the product features, measurement
parameters, and helpful hints about test preparation which are not contained in the Instructions for Use
manual.
The Instructions for Use guides you to the Additional Information with this icon, where more
detailed information is available about a particular topic.
Warnings
Throughout this manual the following meanings of cautions apply:
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.

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List of abbreviations
ABR
Auditory Brainstem Response.
ABRIS
Auditory Brainstem Response Infant Screening.
DPOAE
Distortion Product Otoacoustic Emissions.
TEOAE
Transient evoked Otoacoustic Emissions.
EEG
Electroencephalogram

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Battery life
Estimated Battery Life for Automated ABR Screening = >50
Estimated Battery Life for OAE Screening = >150
*Test duration effects battery life. Test duration depends on the state of the baby and test technique issues
that can vary widely. Therefore, the number of screens per battery charge may vary significantly in your
facility.
**The device should be placed in the charging cradle when not in use so that it does not become fully
discharged. Habitually allowing the battery to fully discharge between charges will shorten the overall life of
the battery.

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Disposables
Ear tips
Selecting the correct size ear tip takes practice. In general, flanged or mushroom shaped ear tips are
recommended for use when measuring DPOAEs, TEOAEs or Automated ABRs.
The table below can be used as a guide to help you select an appropriate ear tip size.
Age (years)
Ear tips inserted into the ear canal
0.5
Ear tip, Preemie
Ear tip 3-5 mm, flanged
Ear tip 4-7 mm, flanged Ear tip 5-8 mm, flanged
Ear tip 7 mm, mushroom Ear tip 8 mm, mushroom
4
Ear tip 9 mm, mushroom Ear tip 10 mm, mushroom
10 Ear tip 11 mm, mushroom Ear tip 12 mm, mushroom
Adult
Ear tip 13 mm, mushroom
Ear tip 14 mm, mushroom
Ear tip 15 mm, mushroom
Ear tip 19 mm, mushroom

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Tips for use of the Sanibel disposable tab and snap electrodes
Figure 1: Tab electrodes
Figure 2: Alligator cables
Figure 3: Snap electrodes
Figure 4: Pinch cables
To ensure the optimal use of your Sanibel disposable tab or snap electrodes, please observe the following:
•Ensure that the skin is clean and dry before placing the electrode
• It is recommended to clean the newborn skin, especially if the skin is greasy or oily, prior
to placing the electrodes
•Use a small amount of conductive electrode gel to improve impedances, if required
•When applying electrodes to the skin, press down firmly on the entire electrode surface to
improve adhesion
•Use pinch cables for snap electrodes and alligator cables for tab electrodes
•Electrode adhesion time is limited to a maximum of 1 hour
•Store unused electrodes in unopened pouches at temperatures 5°-27° C / 40°-80° F
•Use before the expiry date printed on the pouch

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Sensitivity and specificity
What is sensitivity and specificity?
Sensitivity and specificity are common words used when discussing newborn hearing screening given the
importance of detecting those children with a potential hearing loss who require further diagnostic
assessment and treatment.
In a medical diagnosis:
Sensitivity refers to the probability that a test will be positive when the disease is present (true positive).
Specificity refers to the probability that a test will be negative when the disease is not present (true
negative).
These terms can often be confusing in the field of hearing screening. This may be due to the fact that
hearing screening instruments label the outcome of a test where “normal” hearing was detected as a “pass”
whereas the definition above refers to labelling a test that detects a disease as “positive” and non-diseased
or normal as “negative”.
Essentially, hearing screening products should have a high sensitivity, meaning they should be good in
detecting patients with a disease (a potential hearing loss) and labelling the result as a REFER. They also
need to have a high specificity, ensuring patients without the disease (normal hearing) are not unnecessarily
sent on for further diagnostic testing when it was not required.
Sensitivity is principally determined by the instrument implementation (algorithms and hardware). Poor
sensitivity leads to unwanted false passes and can have very serious consequences for the child, as they
would not receive timely and adequate treatment or amplification, leading to potential language development
and social issues.
Specificity is also a measure of instrument implementation, however it also heavily influenced by the test
environment, the tester and the test procedure. Therefore, the specificity quoted by one screening program
with highly trained screeners who screen babies in a quiet room 12-24 hours after the child’s birth, may differ
from another screening program where staff have limited training, babies are tested in noisy test
environments or within hours of being born. Poor specificity (or false refers) can lead to an increased cost to
screening programs requiring babies to be rescreened numerous times or being sent for unnecessary costly
diagnostic assessments. It also leads to increased anxiety for parents or caregivers.

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Preparing for the screening test
The ideal environment for hearing screening is one that is acoustically quiet with minimal potential for
electrical interference (especially important for Automated ABR testing). This may not be easily achieved in a
hospital, where most newborns are screened.
Nevertheless, the screener should be aware of how the environment can impact the testing process and
results and should attempt to control the environment to the extent that it is possible.
If possible, check the external ear canal for wax with an otoscope. Excessive wax should be removed by a
trained professional prior to testing to prevent the probe tip opening from clogging, which will inhibit testing.
Acoustical noise
Acoustical noise in the screening environment can be so loud that the low-level stimulus delivered by the
hearing screening system is overwhelmed by the background noise.
Acoustical noise can also awaken the baby causing less than optimal recording conditions and artifacts that
prolong the test time.
Acoustical noise can lead to a Refer result even for a baby with normal hearing.
What can the screener do to reduce acoustical noise?
•Find a location for the screening that is as quiet as possible, such as an unoccupied patient or
procedure room
•Close the door to the test room to reduce the noise from others walking in the hallway who may be
talking or pushing equipment that is noisy
•Be aware of “hidden” sources of acoustical noise, such as air conditioner vents, motors from devices
or other medical equipment. Try to avoid them by moving as far away as possible
•Ask others in the test room to suspend talking, talk in a quieter voice, and mute or turn off radios or
TVs while the test is being performed
•Ask parents to take young visitors out of the room during the test
Electrical noise & Automated ABR
Electrical noise in the screening environment can cause high artifact levels and generally noisy EEG,
prolonging Automated ABR test times and increasing the chance of a refer result. Electrical noise issues can
be very difficult to troubleshoot and avoid in a hospital environment.
What possible sources of electrical noise should the screener be aware of?
•Other electrical equipment in the test room, especially devices attached to the baby such as other
monitoring equipment
•Nearby cell phones, tablets, computers, walkie-talkies
•MRI or other radiographic equipment located in the vicinity of the nursery, even on the floor above or
below¨
If the screener notices high levels of electrical artifact during testing or an increase in refer rates, these
sources of electrical interference should be considered and eliminated if possible. The screener may need
help from the infant’s nurse or physician to troubleshoot electrical interference issues if it involves other types
of monitoring equipment attached to the baby that are critical to the child’s care.

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OAE probe test
Probe performance is crucial to OAE test results. We recommend that you conduct a probe test at the
beginning of each day before starting to test on patients to ensure that the probe is functioning correctly.
Daily probe test
It is common practice to conduct a probe test at the beginning of each day before starting to test on patients
to ensure that the probe is functioning correctly.
•Before conducting the probe test, ensure that the probe tip is clean and free of wax and/or debris
•Always conduct the probe test in a quiet test environment
•Only use the recommend cavity for testing. Using a different type of cavity may not detect probe
faults
Refer to the Instructions for Use for further information about how to perform this daily probe
test.
Automated ABR patient preparation
6.4.1 General information
The SeraTM with ABRIS (automated ABR) collects electrical signals from the brain via electrodes which are
placed on the baby. As these signals are very small, it is recommended that the baby be asleep or in a very
calm state for testing. The baby can stay in its crib, be placed on an examination table or be held by the
parent.
Ideally, show the electrodes and transducer to be used to the parent before testing and explain the following:
•The aim of the test is to screen the hearing organ for its functionality
•The skin will be prepared before placing three electrodes
•A transducer (probe, insert headphones or EarCups) will be used to deliver the sound to the ear
•A soft clicking sound will be heard during the test
•The baby is not required to do anything during the test as it is automated
•Crying, sucking and movement may result in a longer test time
Please note: All disposable supplies included with SeraTM are produced by Sanibel Supply. The system has
only been tested using disposables supplied by Sanibel Supply. Use of other supplies could alter the
behavior and results obtained with the device and are not recommended. Sanibel disposables are latex,
DEHP and BPA free and have been tested for bio-compatibility. Data sheets are available upon request.
6.4.2 Skin preparation
The skin should be clean and free of lotions or oils. If any greasy skin care products have been used where
the electrodes are to be placed, the lotion/oil should be carefully removed prior to placing the electrodes.
This removal procedure should be discussed with a qualified nurse or doctor.
The electrode sites can be prepared and cleaned in order to obtain lower skin impedances. For this purpose,
a large variety of skin preparation pastes/gels can be purchased. Please note that two different types of
electrode pastes/gels exist: One which is an abrasive gel (such as NuPrep) to abrade the skin and another
which is an electrically conductive paste.

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Typically, if the baby’s skin is clean and free of lotions/oils, you will not need to perform any skin preparation.
However, to lower the skin impedances, follow these instructions:
•Clean the skin where the electrodes will be placed
•Put some of the skin preparation gel (NuPrep) onto a piece of gauze or swab and rub the skin gently
several times. Neonates generally do not require excessive abrasion and in some cases, it may
make impedances worse
•Remove any excessive abrasive gel and ensure the skin is dry before placing the electrodes
•If the baby’s skin is dry or you are obtaining high impedances, applying a small amount of conductive
gel/paste to the baby’s skin prior to connecting the surface electrode will help to rehydrate the skin
and to lower impedances
6.4.3 Electrode preparation sites for the nape montage
Clean each of the electrode sites as per the illustration below prior to placing the electrodes on the skin.
High forehead (centered) near the
hairline
Cheek (or shoulder)
Nape (just below the hairline)
6.4.4 Electrode placement for the nape montage
Place the electrodes on the prepared electrode sites on the skin as illustrated below.
Note: All three electrodes must be positioned in order to perform testing.
High forehead (centered) near the
hairline
Cheek (or shoulder)
Nape (just below the hairline)
Please note: The disposable electrodes supplied with the unit are single use only. If reusable electrodes are
to be used, cleaning and disinfecting procedures should be clarified with your hospital’s infection control
department.

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6.4.5 Preamplifier cable connections
After preparing the skin and placing the three electrodes on the baby, connect the electrode cables to the
electrodes.
Figure 5
Ensure that the electrode cables are securely connected into the correct
electrode jack on the top of the preamplifier, matching the color of the
cable with the jack. The graphic near the electrode jacks on the
preamplifier illustrates proper placement of electrodes for the nape
montage (Figure 5).
Connect the cables to the electrodes as follows:
Electrode lead color Electrode location (nape montage)
White High forehead (centered) near the hairline
Black Cheek (either side) or shoulder
Yellow Nape (just below the hairline)
6.4.6 Place transducers
Different transducers can be used with the SeraTM for Automated ABR testing. At the time of purchase you
chose your preferred style of acoustic transducer – probe, insert earphones with ear tips or insert phones
with EarCups. All use single-use disposable supplies.
Re-use of single-use disposables enhances the risk of cross contamination!
6.4.7 Insert earphones with EarCups
Figure 6: EarCup setup
The EarCup is an around-the-ear coupler that connects to the tubing of the
insert earphones using the EarCup adapters. The EarCups adhere to the
skin around the baby’s ear.
Insert the EarCup adapter at the end of each of the insert earphone tubes
into the hole in the foam at the top of the EarCup so that it is fully inserted
(Figure 6).

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Figure 7: Baby with EarCups
Peel the EarCup attached to the red tubing from the backing card. Place it
around the baby’s right ear with the adapter and tubing pointing toward the
top of the head. Press around the entire circumference of the EarCup to
ensure adhesion to the baby’s skin.
Peel the EarCup attached to the blue tubing from the backing card. Place it
around the baby’s left ear with the adapter and tubing pointing toward the
top of the head. Press around the entire circumference of the EarCup to
ensure adhesion to the baby’s skin.
Place the insert earphone transducer boxes above or to the side of the
baby’s head away from electrode leads to reduce electrical interference.
6.4.8 Insert earphones with ear tips
The ear tip is a small silicone tip that is placed on the infant ear tip adapter that is attached to the tubing of
the insert earphones. The ear tip is inserted into the baby’s ear canal.
Do not insert the ear tip adapter into the baby’s ear without an ear tip
attached.
Please note: When using insert earphones, you cannot use the same
transducer for testing both ears. Only use the red colored transducer for the
right ear and the blue transducer for the left ear.
Figure 8: Insert earphone ear
tip adapter with ear tip
Choose the appropriate size of ear tip based on your inspection of the size
of the baby’s ear canals (Figure 8). The Sanibel green ear tip fits most
newborn ears. Other sizes are available for larger ear canals.
Place the ear tips onto the ear tip adapters at the end of the insert earphone
tubing.
Figure 9: Insert earphone in
baby’s ear
Insert the ear tip attached to the red tubing into the baby’s right ear. Do this
by pulling gently down and out on the baby’s ear lobe to open up the ear
canal. Hold the adapter, aim and gently twist the ear tip into the ear canal.
The fit of the ear tip should be secure; not superficial. Release the earlobe.
Repeat this procedure for inserting the ear tip attached to the blue tubing
into the baby’s left ear
If you find that it is difficult to keep both ear tips secure in the baby’s ear
canals at the same time, you can choose to test one ear at a time. It is
important that you use the transducer with the red tubing for the right ear
and the transducer with the blue tubing for the left ear.
Place the insert earphone transducer boxes above or to the side of the
baby’s head to reduce electrical interference (Figure 9).

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6.4.9 Probe
Do not insert the probe tip into the patient’s ear canal without a disposable
ear tip attached.
Figure 10: Probe with ear tip
Choose the appropriate size of ear tip based on your inspection of the size
of the baby’s ear canals (Figure 10). The Sanibel green Preemie and the
red flanged ear tip fits most newborn ears. Other sizes are available for
larger ear canals.
Place the ear tip onto the probe tip.
Figure 11:Automated ABR
using the probe
Insert the probe with ear tip attached into the baby’s first test ear. Do this
by pulling gently down and out on the baby’s ear lobe to open up the ear
canal. Hold the probe, aim and gently twist the ear tip into the ear
canal.The fit of the ear tip should be secure; not superficial. Release the
earlobe. You should not hold the probe during the measurement as this
can produce excessive noise in the recording, prolonging the test time.
OAE patient preparation
6.5.1 General information
The SeraTM with DPOAE and TEOAE records otoacoustic emissions emitted by the outer hair cells, located
in the cochlea. As these signals are very small, it is recommended that the baby be asleep or in a very calm
state for testing. The baby can stay in its crib, be placed on an examination table or be held by the parent.
Ideally, show the probe to the parent before testing and explain the following:
•The aim of the test is to screen the hearing organ for its functionality
•A transducer (probe) will be used to deliver the sound to the ear
•A soft clicking sound will be heard during the test
•The baby is not required to do anything during the test as it is automated
•Crying, sucking and movement may result in a longer test time
Please note: All disposable supplies included with SeraTM are produced by Sanibel Supply. The system has
only been tested using disposables supplied by Sanibel Supply. Use of other supplies could alter the
behavior and results obtained with the device and is not recommended. Sanibel disposables are latex, DEHP
and BPA free and have been tested for bio-compatibility. Data sheets are available upon request.