
Chapter
1:
Introduction
and
Safety
Information
A.
About
the
B
‐
ALERT
X10
The
B
‐
ALERT
X10
is
an
internally
battery
powered
FDA
‐
classified
Type
BF
device
intended
for
continuous
use
(7
‐
9
hours).
The
B
‐
ALERT
X10
provides
an
integrated
approach
for
wireless
acquisition
and
recording
of
electroencephalographic
(EEG),
electrooculographic
(EOG)
and
electrocardiographic
(ECG)
signals.
The
system
utilizes
the
patented
B
‐
Alert
Sensor
Headset
and
EEG
sensors,
which
record
high
quality
EEG
that
can
be
obtained
in
five
‐
minutes
of
set
‐
up
time
with
no
scalp
preparation.
The
wireless
technology
allows
the
user
to
be
untethered
and
move
around
the
clinic
(or
in
the
field)
while
real
time
data
is
collected,
displayed,
and
analyzed.
The
B
‐
ALERT
X10
acquires
nine
channels
of
monopolar
EEG
recordings
with
a
linked
mastoid
reference.
The
10
th
channel
is
a
programmable
gain
option
that
can
be
used
for
EOG
or
ECG.
The
B
‐
ALERT
X10
consists
of:
Head
and
Host
Units
for
bi
‐
directional
transmission
of
digitized
physiological
signals,
a
Neoprene
Strap,
and
a
Sensor
Strip
with
EEG
sensor
sites
in
the
frontal
(Fz,
F3
and
F4),
central
(Cz,
C3
and
C4)
and
parietal
‐
occipital
(POz,
P3,
and
P4)
regions.
The
Sensor
Headset
collects
physiological
signals
from
the
sensors
placed
on
the
user
sampling
at
256
Hz.
The
headset
performs
analog
‐
to
‐
digital
conversion,
encoding,
formatting
and
transmitting
of
all
signals.
The
signals
communicate
using
a
2.4
to
2.48
GHz
radio
transmitter.
B
‐
Alert
Acquisition
utilizes
the
bi
‐
directional
capabilities
of
the
system
to
initiate
scalp
‐
electrode
impedance
monitoring,
and
monitors
the
battery
capacity
in
the
Head
Unit.
A
custom
USB
Host
Device
(B
‐
Alert
Dongle
or
ESU
‐
MC)
is
used
as
the
base
unit
affixed
to
the
PC
workstation.
B
‐
Alert
Acquisition
software
consists
of
several
modules
that
allow
the
user
to
acquire,
store,
view,
and
analyze
physiological
signals
acquired
by
the
wireless
system.
The
software
provides
a
simple
graphical
interface
for
establishing
and
controlling
data
acquisition.
Patented
algorithms
can
be
selected
to
monitor
artifacts
that
impact
signal
quality
in
real
time,
and
provide
users
feedback
when
thresholds
(for
artifact)
are
exceeded.
EEG
Power
Spectral
Densities,
EEG
classifications,
and
Heart
rate
measures
can
be
generated
in
real
‐
time
or
off
‐
line.
B.
Intended
Use
The
B
‐
Alert
X10
system
is
intended
for
use
in
clinical
and
research
settings,
by
trained
technicians,
to
measure
and
record
the
electrical
activity
originating
from
the
brain
(EEG),
the
BIOPAC Systems, Inc.
B-Alert X10 User Manual
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3