Performance
Electrical
Environmental Conditions
Physical Characteristics
Compliance
PERFORMANCE
Measurement
Range
Sp02
Pulse Rate
1
-
100%
20
-
250 beats per minute
(bprn)
Saturation (%Sp02 +1
SD)
Without Motion:
Adults
Neonates
70
-
100% A2 digits
70
-
100%
53
digits
1
-
69%
unspecified
Witli M~tion:~
Adults and Neonates
70
-
100%
&3
digits
1
-
69%
unspecified
Accuracies are expressed as plus or minus
"X"
digits (oxygen saturation percentage points)
between saturation of 70% and 100%. This variation equals plus or
minils one standard deviation
(I
SD), which encompasses
68%
of the population. All accuracy specifications are based on testing
the subject monitor
on
healthy adult volunteers in induced hypoxia studies across the specified
range. Adult accuracy is
detennined with Oxisensor
11
D-25 sensors. Neonatal accuracy is
detennined wit11 Oxisensor
11
N-25 sensors.
For a
definition of motion, as applicable to the N-395, contact Mallinckrodt's Technical Services
Depart~nent.
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