LBL
‐
0176,
Rev
1|
User
Supplemental
Information,
Proteus®
Patch
Page
2
of
2
Effective:
19DEC2013
1.
TECHNICAL
INFORMATION
1.1
–
Classification
Caution:
Federal
(U.S.A)
law
restricts
this
device
to
sale
by
or
on
the
order
of
a
physician.
The
Proteus
Patch
is
categorized
as
Class
II
(in
US)
and
IIa
(in
EU).
The
User
(patient)
is
the
intended
Operator
of
the
Proteus
Patch.
1.2
–
Environmental
Conditions
The
Proteus®
Patch
is
intended
for
storage
and
operation
in
a
room
‐
temperature
environment.
Condition
Temperature
Humidity
Pressure
(Altitude)
Operating
20
C
–
28
C
15%
‐
93%
700
hPa
–
1060
hPa
Storage
20
C
–
28
C
15%
‐
93%
700
hPa
–
1060
hPa
Transport
2
C
–
38
C
15%
‐
85%
700
hPa
–
1060
hPa
1.3
–
Minimizing
Skin
Irritation
The
Proteus
Patch
has
been
designed
to
minimize
the
possibility
of
skin
irritation.
Observing
these
cautions
will
reduce
the
likelihood
of
skin
irritation
or
bruising
under
the
Patch:
DO
NOT
continue
use
until
further
instruction
by
a
physician
if
your
skin
is
irritated
or
inflamed
around
the
patch.
DO
NOT
place
in
locations
where
your
skin
is
scraped,
cracked,
inflamed,
or
irritated.
DO
NOT
place
in
a
location
that
overlaps
the
area
of
the
most
recently
removed
Patch.
DO
NOT
use
if
you
are
allergic
to
adhesive
tape.
DO
NOT
wear
the
same
Patch
for
more
than
one
week.
DO
NOT
drop
or
bump
with
excessive
force.
1.4
–
Protection
against
Ingress
of
Solids
and
Liquids
The
Proteus
Patch
has
an
Ingress
Protection
rating
of
IP27.
This
means
that
the
enclosure
has
no
penetrations
and
it
has
been
rated
for
immersion
in
liquid
up
to
1m
depth.
For
continued
safety,
should
the
enclosure
become
penetrated
or
torn,
remove
the
Patch
immediately
and
replace
it
with
a
new
one.
1.5
–
Avoiding
Unsafe
Use
Conditions
The
Proteus
Patch
is
not
a
diagnostic
device.
DO
NOT
attempt
to
use
it
to
diagnose
heart
‐
related
conditions,
an
incorrect
diagnosis
may
result.