18 Prima 451 – User Manual
Specification
4.11 Device
Classification
and
L
a
b
e
lli
ng
Mode of
operation:
Continuous
Type B
Applied
P
a
r
t:
Degree of protection against electric shock
This symbol denotes: Type B equipmen
t
Class 1 C
l
a
ss
i
f
i
c
a
t
i
on
Type of protection against electric shock: Class 1
IPX0 Ingress
P
r
o
t
e
c
t
i
on
Classification according to the degree of protection against ingress of water: IPX0 (not protected)
Labelling:
Refer to Appendix 3
Patient Class
All patient types
No residual risks from phthalates that are carcinogenic, mutagenic, or toxic to reproduction.
Magnetic Resonance (MR) Conditional
The Prima 451 is a MRI-conditional machine and includes special components that allow it to operate in a
MRI environment.
The Prima 451 poses no known hazard in a specified MR environment (see below), with specified conditions of use
(see section 1) and specific configurations.
Specified MR environment
The Prima 451 is approved for use in a magnetic resonance (MR) environment up to the 1000 gauss (100 mT) line,
with scanners rated at 1.5 tesla and 3 tesla.
CAUTION
Special operational conditions apply to Prima 451 systems with the AV-S MRI ventilator - see Appendix 5.
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