
Slipping
hazard:
Ensure
that
any
water
leaks
or
spills
are
immediately
wiped
up.
Trip
hazard:
Carefully
organize
the
layout
of
the
incoming
power
and
water
lines
for
safety.
The
sterilizer
has
a
pressure
vessel
that
has
been
ASME
B&PV
code
stamped.
It
is
a
violation
of
federal
code
to
replace
the
main
door
plate
or
make
any
weld
repairs
to
the
pressure
vessel.
All
repairs
to
the
pressure
vessel,
including
the
door
plate,
must
be
made
by
FDI.
Sterility
could
be
compromised
if
Bowie
‐
Dick,
vacuum
‐
leak,
or
biological
indicator
testing
indicates
a
problem.
Refer
any
concern
to
a
qualified
equipment
technician
before
continuing
to
use
the
sterilizer.
Do
not
re
‐
use
biological
indicators
(BIs),
chemical
integrators
(CIs)
or
Bowie
‐
Dick
Test
Packs.
Check
the
expiration
date
before
use.
Sterility
could
be
compromised
if
Association
for
the
Advancement
of
Medical
Instrumentation
(AAMI)
guidelines
are
not
followed
for
cleaning,
decontaminating,
packaging,
and
preparing
prior
to
sterilization.
In
addition,
it
is
critical
for
the
user
to
follow
AAMI
guidelines
to
conduct
routine
biological
monitoring
to
verify
the
sterilization
performance.
Refer
to
the
instrument
device
manufacturer’s
Instructions
for
Use
(IFU)
before
selecting
the
appropriate
cycle,
including
exposure
and
dry
times.
The
P2131
sterilizer
is
designed
to
sterilize
loads
using
only
the
FDA
‐
cleared
cycles
as
specified
in
this
manual.
If
you
have
any
question
or
concern
about
a
specific
material,
instrument,
or
device,
contact
the
manufacturer
of
the
device
to
obtain
the
specific
IFU.
The
P2131
sterilizer
does
not
include
a
sterilization
cycle
for
liquids.
DO
NOT
ATTEMPT
TO
STERILIZE
ANY
LIQUIDS
IN
THIS
STERILIZER.
After
transport
and
relocation,
the
installation
must
include
proper
Installation,
Operational,
and
Performance
Qualification
(IQ/OQ/PQ)
testing
per
AAMI
standards.
Reference
Section
3.1.
Do
not
use
compressed
air
to
hasten
the
draining
or
drying
process
as
the
high
pressure
could
damage
the
pressure
vessel
(40
psig
MAWP),
WRS
water
tank,
or
instrumentation.
Do
not
remove
orange
‐
colored
insulation
sleeves
that
are
used
throughout
the
sterilizer.
The
insulation
sleeves
protects
the
user
from
potential
burns
and
ensures
correct
performance
of
the
Sterilizer.
Replace
if
it
becomes
damaged
and/or
lost
during
maintenance.
WARNINGS
2
Содержание P2131
Страница 121: ... THIS PAGE INTENTIONALLY LEFT BLANK 115 ...
Страница 130: ...SECTION A APPENDIX 124 ...
Страница 131: ...A 1 Swagelok Fitting Installation Instructions 125 ...
Страница 135: ...A 2 PLC Data Sheet 129 ...
Страница 141: ...A 3 VERIFY Product Information 135 ...
Страница 147: ...A 4 WRS Pump Information 141 ...
Страница 158: ...A 5 Vacuum Leak Test Troubleshooting Guide 152 ...