Prima 451 – User Manual 3
Warnings and Cautions
d) It is the user’s responsibility to ensure that any
third-party components required for the filling
process are suitable for use in the MR facility.
Remove these components from the MR facility
after filling the vaporizer.
9. This apparatus is designed for use only with
non-
flammable
anaesthetic
agents. Do not use with or in
close
proximity
to
f
l
a
mm
a
b
l
e
anaesthetic
agents,
due to a
possible
fire
o
r
explosion h
aza
r
d
.
10. Only authorised personnel should remove exterior
panels, and the system
m
u
s
t
not be operated with such
panels
m
i
ss
i
ng
.
11. U
nauthorised
personnel must not attempt
t
o
access
fuses or other
electrical
c
o
m
pon
e
n
t
s
. There is a
possible
electric shock
h
aza
r
d
.
To isolate the machine from the mains power supply,
disconnect the mains cable from the hospital power
outlet.
Always use a mains power outlet socket that can be
easily accessed.
12. No oil, grease or other flammable
lubricant
o
r
sealant
must be used on any part of the
m
a
c
h
i
n
e in close
proximity
to medical gas
d
i
s
t
r
i
bu
t
i
on
c
o
m
pon
e
n
t
s
.
There is a risk of fire or e
x
p
l
o
s
i
on
.
13. Attaching
or removing a medical gas
cy
li
nd
e
r
:
a) Follow
appropriate
manual
h
a
nd
li
ng guidelines
when lifting
.
b) Ensure that the machine yoke and
cy
li
nd
e
r
faces
are dust free and clean and that the
s
ea
li
ng
washer provided is in
position
between
t
h
e
cylinder
valve and the
y
o
k
e.
c) Tighten the yoke securely before opening
t
h
e
cylinder
valve. Dust and dirt presents a
f
i
r
e
hazard in the presence of high pressure
g
a
s
.
Leakage of high pressure gas can cause
serious
injury
.
d) See also Warning 5.
14. Anaesthesia
apparatus must be connected to a
n
anaesthetic
gas
scavenging
system (AGSS)
t
o
dispose
of waste gas and prevent
possible
h
ea
l
t
h
hazards to
clinical
s
t
a
ff
.
This
requirement
must be observed during
t
e
s
t
procedures
as well as during use with a
p
a
t
i
e
n
t
.
15. Prima 451 anaesthetic machines must only be
u
s
e
d
with
Sigma Delta
vaporizers
installed
on
t
h
e
Selectatec-
type
backbar
sys
t
e
m
.
Free-standing vaporizers
may be a
cc
i
d
e
n
t
a
ll
y
tipped,
resulting
in excessive and
un
c
a
li
b
r
a
t
e
d
volumes of
anaesthetic
drug entering
t
h
e breathing
sys
t
e
m
Do not install or connect any
vaporizers
of a
n
y
description
between the common gas o
u
t
l
e
t
(CGO)
and the breathing system unless they a
r
e
specifically
designed for such
u
s
e. (If this is done, the oxygen flush
flow will
p
a
ss
through the vaporizer and may result in
g
r
o
ss
overdosage when the flush valve is
op
e
r
a
t
e
d
.
)
16. Only
vaporizers
with the Selectatec
c
o
m
p
a
t
i
b
l
e
interlock function
will
interlock
when
installed
on
the two station
m
a
n
i
f
o
l
d
.
The
installation
of
non-interlock
v
a
po
r
i
ze
r
s
allows
the
possible
operation of more than
one
vaporizer at
the same
t
i
m
e.
17. The breathing system which conveys gases
f
r
o
m
the
anaesthetic
machine to the patient a
nd disposes
of expired gases is a vital part of
t
h
e
anaesthetic
delivery
sys
t
e
m.
Because breathing systems require
f
r
e
qu
e
n
t
cleaning
and
disinfection
they are not a permanent part
of the
anaesthetic
machine
and
therefore cannot
be
directly
under the
control
o
f
the
anaesthetic
machine
m
a
nu
f
a
c
t
u
r
e
r
.
When
mechanical ventilation
is employed
t
h
e patient
breathing system must be
c
onn
e
c
t
e
d
directly
to an
over-pressure
relief valve
t
o
prevent the
possibility
of
b
a
r
o
t
r
a
u
m
a.
18. Always perform a pre-use check of the anaesthesia
system,
including vaporizers, ventilator,
circle
a
b
s
o
r
b
e
r
and
monitors
before
clinical
use.
Follow the
p
r
e
-
use
checklist
(see section 5) as a
m
i
n
i
m
u
m
r
e
qu
i
r
e
m
e
n
t
.
Many
clinical incidents
occur because of a
f
a
il
u
r
e to
check for correct
f
un
c
t
i
on
.
19. The machine must not be used if any of the a
l
a
r
m
,
monitoring
or
protection
system devices are
not
functioning c
o
rr
e
c
t
l
y
.
20. The gas supply failure systems within
t
h
e
anaesthetic
machine will not
necessarily
op
e
r
a
t
e as
indicated
in
this manual during a
n
y
procedures
that are outside
the scope of
t
h
e
indications
for use of the
m
a
c
h
i
n
e
:
a) Machine set to deliver Air
on
l
y
When the machine is operated with an Air flow
only, note that there may still be retained oxygen
in the system, and that the oxygen supply visual
indicator will continue to indicate green, even
though oxygen is not being delivered.
b) Machine set to deliver Oxygen only
t
h
r
ough
Auxiliary O
u
t
l
e
t
s
The oxygen failure alarm is designed to operate
during normal use of the machine, i.e. when
providing controlled concentrations and flows of
gases to a patient breathing system, as described
in Section 2 (Purpose).
Do not use the machine solely to provide large
flows of oxygen, via the anaesthetic machine
auxiliary outlets, to external devices which may not
be equipped with a supply failure alarm.
21. The machine must not be fitted with more
t
h
a
n
three
operator
accessible
mains socket
ou
t
l
e
t
s
. There is a
risk of an excessive leakage
c
u
rr
e
n
t
.
Note that when the user connects equipment to a
machine auxiliary outlet a medical electrical system is
created as defined in IEC 60601-1-1.
This can result in a reduced level of safety (see also
Warnings 1 and 3 and Caution 8).
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