Maico MB 11 BERAphone, Operation Manual

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Operation Manual MB 11 BERAphone
®
/Classic
8100496 Rev. 6 4 23/10/2019
Indications for Use
The MAICO MB 11 BERAphone
®
/Classic is designed to be used only by trained
personnel (Audiologists, Physicians or other trained, supervised personnel). No person
should attempt to use this instrument without the necessary knowledge and training
to understand how this equipment is to be properly utilized and interpreted.
The device shall be used in a hospital, clinic, healthcare facility or other suitable quiet
environment as defined in standard ISO 8253-1. Hearing screenings are most
successfully and efficiently performed in acoustically quiet surroundings. While this is
not always achievable in a hospital environment, the screener should be aware of
acoustic noise and control it to the extent that this is feasible.
Contraindications of Use
Contraindications to testing include recent stapedectomy or middle ear surgery, a
discharging ear, acute external auditory canal trauma, discomfort (e.g., severe otitis
externa) or occlusion of the external auditory canal. Testing should not be performed
on patients with such symptoms without a medical doctor’s approval.
The BERAphone
®
/Classic is intended for use on intact, external skin around the ears
and on the scalp. It should not be used if the skin is not intact or if the baby has a
contagious dermatological condition.
Essential Performance
There is no essential performance as defined in IEC 60601-1.
Features and Benefits
General Information about the MB 11
The MB 11 features (dependent on version):
•
Screening ABR with patented CE-CHIRP
®
stimulus and automatic impedance test
•
Powerful response detection algorithms
•
Multiple ABR transducer choices including the unique, patented BERAphone
®
which eliminates the need for disposable electrodes and ear couplers
•
BERAphone
®
with reusable spring-mounted, stainless-steel electrodes,
preamplifier and speaker integrated in one unit
•
Use of MB 11 Classic with EarCups
TM
or eartips
•
Simple Pass/Refer outcome
The MB 11 is available with or without a label printer.