General Test Information; Patient Preparation - Automated Abr Testing; Patient Preparation - Oae Testing; Handling And Selection Of Ear Tips - Interacoustics Sera Instructions For Use Manual

General test information

It is important to secure the consent of the patient, or in case of the patient being underage, the patient's
parents or custodian. It is furthermore recommended to give the patient and attending patient's relations a
general outline of the test procedure, what to expect and how to interpret the test result.
4.6.1 Patient preparation – Automated ABR testing
During Automated ABR testing, electrical signals from the neurologic pathway between the cochlea and the
brainstem are collected via electrodes which are placed on the baby. As these signals are very small and
can be disturbed by myogenic signals, it is recommended that the baby is 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.
Preparing the skin helps to achieve good contact (i.e. low impedance) between the skin and the electrode.
After cleaning, remove any residue of the skin prep product so that the skin is dry. This will help to ensure
good adhesion of the disposable electrode to the skin.
The electrodes used by Sera
ears and on the scalp. They should not be used if the skin is not intact of the baby has a contagious
dermatological condition.
Please refer to the Sera
patient and which electrode montage to use.
4.6.2 Patient preparation – OAE testing
OAE responses are very small, and 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 during
testing
.
Please refer to the Sera
patient for testing.

4.6.3 Handling and selection of ear tips

The Sanibel ear tips are single use only and should not be reused. Reuse of ear tips can lead to the
TM
spread of infection from patient to patient.
The probe and insert phones must be fitted with an ear tip of a suitable type and size before testing. Your
choice will depend on the size and shape of the ear canal and ear. Your choice may also depend on
personal preference and the way you perform your test.
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
with ABRIS are intended for use on intact, external skin around the
TM
Additional Information for further instructions on how to prepare the
TM
Risk of strangulation.
Keep cables away from baby's neck.
Avoid contact between the unused electrodes and any other conductive
parts.
Additional Information for further instructions on how to prepare the
TM
Page 31