4
2015
General
Information
1.4
Intended Purpose
The
InnuPure
®
C96
provides
an
extraction
tool
that
is
intended
for
complete
isolation
and
purification
of
nucleic
acids.
The
available
range
of
applications
is
restricted
by
the
scope
of
included
functional
soft-
ware
and
firmware,
as
well
as
the
scope
of
delivery.
For
this
reason,
the
user
is
prohibited
from
operating
the
system
in
any
way
other
than
specified
in
this
User
Manual.
1.5
Conforming Use
Conforming
use
of
the
InnuPure
®
C96
is
mainly
distinguished
by
automated
processing
sequences
(process
steps)
using
liquid
handling
principles
and
purification
procedures,
based
on
magnetic
particle
separation.
Conforming
use
is
understood
to
mean
operation
with
96
deep
well
microplates
(stan-
dard
SBS
format).
Different
(tested)
extraction
kits
are
available
for
use
with
the
InnuPure
®
C96,
for
example:
kit
for
isolation
of
genomic
DNA,
kit
for
isolation
of
viral
or
bacterial
nucleic
acid,
kit
for
the
processing
of
forensic
samples.
System
operation
will
be
deemed
as
conforming
if
solely
based
on
extraction
kits
that
have
been
approved
by
the
manufacturer
and
specified
for
use
with
the
InnuPure
®
C96.
The
InnuPure
®
C96’s
basic
(automated)
functions
provide
pipetting,
mixing
and
heating
procedures.
Necessary
manual
interventions
are
reduced
to
a
minimum.
The
term
conforming
use
further
includes
supervised
monitoring
(by
qualified
personnel)
of
processes
carried
out
in
automatic
mode.
The
definition
for
non-conforming
use
includes:
operating
the
system
in
medical
laboratories
of
a
non-research
profile
working
with
explosive
substances
working
in
an
explosive
atmosphere
–
operation
in
a
potentially
explosive
zone
is
prohibited
Summary of Contents for 845-00003-03
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