D
‐
0125127
‐
C
36
Safety
Regarding
electrical
safety,
this
device
is
designed
to
be
used
only
by
professionals
in
the
hearing
healthcare
industry.
It
is
Class
II
Medical
Electrical
(ME)
equipment
that
is
part
of
an
ME
system.
This
device
provides
Type
B
protection
(Type
B
equipment,
Type
B
applied
part)
This
device
is
not
protected
from
ingress
of
water.
Power
is
supplied
by
an
un
‐
grounded
mains
power
cable
to
a
medical
grade
power
supply
and
also
supplied
by
the
USB
cable
connected
to
a
computer.
The
USB
computer
power
must
be
able
to
supply
at
least
500mA
at
the
standard
USB
voltage.
A
USB
Optical
Isolator,
with
a
minimum
of
1500V
AC
isolation
should
be
placed
in
‐
line
between
the
computer’s
USB
connection
and
the
MedRx
device.
The
Optical
Isolator
should
be
powered
by
a
power
supply
that
conforms
to
IEC
60601
‐
1.
The
computer,
Optical
Isolator’s
power
supply
and
the
speaker’s
power
supply
should
be
connected
to
the
Medical
Grade
isolation
transformer
that
conforms
to
IEC
60601
‐
1.
Follow
the
manufacturer’s
instructions
for
installation
and
use.
All
connected
equipment
provides
2
MOPP
per
IEC
60601
‐
1.
This
device
is
to
be
operated
on
non
‐
conductive
surfaces
only.
The
computer
used
with
this
device
should
conform
to
the
requirements
of
IEC
60601
‐
1.
A
MULTIPLE
PORTABLE
SOCKET
‐
OUTLET
or
extension
cord
shall
not
be
connected
to
the
system.
The
device
warm
‐
up
time
is
less
than
5
minutes.
Use
only
the
15
VDC,
2A
medical
power
supply
supplied
with
your
Avant
REM,
CUI
ETMA
150200UD
‐
P5P
‐
IC.
The
power
supply
cable
should
always
be
accessible
in
order
to
disconnect
it
from
the
supply
mains.
Do
not
connect
items
that
are
not
specified
as
part
of
the
system.
The
use
environment
should
be
between
10°C
and
35°C
,
humidity
within
30%
to
90%
and
an
atmospheric
pressure
range
from
80
kPa
to
104
kPa.
Storage
temperature
range
at
least
from
‐
20°C
to
50°C
and
humidity
level
from
10%
to
90%.
All
components
with
patient
contact
are
made
of
bio
‐
compatible
materials.
This
device
does
not
produce
any
adverse
physiological
effects.
Install
the
device
as
directed
by
this
manual
to
achieve
optimal
use.
Clean
accessories
per
the
cleaning
instructions
prior
to
use.
No
Sterilization
is
required
for
components
of
this
device.
However,
new
probe
tubes
are
needed
for
each
patient
where
applicable,
and
cleaning
of
the
device
and
accessories
should
follow
the
procedure
outlined
below.
The
device
is
not
intended
to
be
operated
in
an
environment
with
anesthetics,
oxygen
or
NO.
It
is
not
an
AP
or
APG
device.
This
ME
System
is
not
intended
for
use
with
flammable
anesthetics.
This
device
uses
Type
B
application
parts
temporarily
placed
on
the
patient
during
testing.
They
are
nonconductive
and
can
be
immediately
withdrawn
from
the
patient
at
any
time.
The
device
is
intended
for
continuous
operation.
The
computer
and
the
MedRx
device
or
accessories
may
be
located
in
the
patient
environment
if
required.
The
colored
lights
are
as
designated
by
ANSI
S
3.6
and
IEC
60645
‐
1,
conforming
to
the
standard
color
designations
for
audiology.
They
signify
that
either
the
left
(blue)
channel
is
active
or
the
right
(red)
channel
is
active,
or
no
channel
is
active
(green).
The
colors
do
not
signify
any
dangerous
or
faulty
condition.
Contact
the
local
MedRx
distributor
for
safe
and
proper
disposal
of
this
equipment.
Proper
disposal
may
require
that
it
be
sent
to
collection
facilities
for
recovery
and
recycling.
All
repairs
should
be
sent
to
MedRx
for
evaluation
and
/
or
repair.
However,
necessary
diagrams
and
repair
instruction
will
upon
request
be
provided
to
authorized
repair
personnel.
The
Instructions
for
Use
(the
Installation
and
Software
Training
manuals)
are
supplied
as
an
electronic
copy
on
a
USB
flash
drive.
Paper
copies
of
the
manuals
may
be
also
requested
from
the
company,
and
will
be
sent
within
one
business
day
of
the
request.
There
are
no
known
contraindications
for
the
use
of
this
equipment.
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