4
to
monitor
a
critical
function.
♦
The
internal
speakers
of
this
touchmonitor
must
not
be
the
sole
method
of
warning
of
a
critical
function.
Critical
functions
are:
1.
Life
support
devices
or
systems
are
devices
or
systems
which,
(a)
are
intended
for
surgical
implant
into
the
body,
or
(b)
support
or
sustain
life,
or
(c)
whose
failure
to
perform
when
properly
used
in
accordance
with
instructions
for
use
provided
in
the
labeling,
can
be
reasonably
expected
to
result
in
significant
injury
to
the
user.
2.
A
critical
component
is
any
component
of
a
life
support
device
or
system
whose
failure
to
perform
can
be
reasonably
expected
to
cause
the
failure
of
the
life
support
device
or
system,
or
to
affect
its
safety
or
effectiveness.
Table of Contents
INTRODUCTION
................................................................. ..................... ................... 7
