D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN Page 31
4.6 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.
Af ter 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
TM
with ABRIS are intended for use on intact, external skin around the
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
TM
Additional Information for further instructions on how to prepare the
patient and which electrode montage to use.
Risk of strangulation.
Keep cables away from baby’s neck.
Avoid contact between the unused electrodes and any other conductive
parts.
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
TM
Additional Information for further instructions on how to prepare the
patient for testing.
4.6.3 Handling and selection of ear tips
The Sanibel
TM
ear tips are single use only and should not be reused. Reuse of ear tips can lead to the
spread of inf ection f rom 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 pref erence and the way you perform your test.
To Next Page
Loading...
