Cardinal Health Alaris 8000 Series, Directions For Use Manual

Page: 272 / 378

4-28
General Information
Alaris
®
System Directions for Use
SpO
2
Modules Section
Specifications (Continued)
Specifications and Symbols (Continued)
8220 Series (Continued)
(8220)
Measurement Range:
Perfusion
0.02
-
20%
Pulse Rate
25
-
240
bpm
SpO
2
1
-
100%
Pulse Amplitude Display: Proportional to height of
I.Q.
signal.
Sensor: Emitted light wavelength range is within
500
-
1000
nm. Output power does not
exceed
1
mw.
NOTES:
€
Specification applies to Nellcor
®
Board performance and was validated with
BIO-TEK
and Nellcor
®
Simulators.

Applicability: O
XI
M
AX
® MAX-A
,
MAX-AL
,
MAX-P
,
MAX-I
and
MAX-N
sensors.
‚
Adult specifications are shown for O
XI
M
AX
® MAX-A
and
MAX-N
sensors with
S
p
O
2
Module. Neonate
specifications are shown for O
XI
M
AX
® MAX-N
sensors with
S
p
O
2
Module. Saturation accuracy will vary by
sensor type.
ƒ
Masimo
®
Board performance has been validated for low perfusion accuracy in bench–top testing against a
BIO-TEK
simulator and a Masimo
®
simulator.
„
Masimo
®
Board performance has been validated for motion accuracy in human blood studies on healthy
adult volunteers in induced hypoxia studies, while performing rubbing and tapping motions at
2
-
4
Hz at an
amplitude of
1
-
2
cm and a nonrepetitive range of
70
-
100% S
p
O
2
against a laboratory co–oximeter and
ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard
deviation encompasses
68%
of the population.
Masimo
®
Board performance with Masimo
® LNOP ®
Neo and Neo Pt sensors has been validated for
neonatal motion accuracy in human blood studies on neonates, while moving the neonate’s foot at
2
-
4
Hz
at an amplitude of
1
-
2
cm against a laboratory co–oximeter and
ECG
monitor. This variation equals plus
or minus one standard deviation. Plus or minus one standard deviation encompasses
68%
of the
population.
†
Masimo
®
Board performance has been validated for no-motion accuracy in human blood studies on healthy
adult volunteers in induced hypoxia studies, in the range of
70
-
100% S
p
O
2
against a laboratory
co–oximeter and
ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses
68%
of the population.