BeneVision TM80, Operator'S Manual

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BeneVision TM80 Telemetry Monitor Operator’s Manual A - 13
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A functional tester or SpO
2
simulator can be used to determine the pulse rate
accuracy.
A.8.3.1 Masimo SpO
2
Module
SpO
2
Measurement range
1% to 100%
Resolution
1%
Accuracy*
70-100%: ±2.0% (measured without motion)
70-100%: ±3.0% (measured with motion)
1-69%: Not specified
Low Perfusion Conditions
Pulse amplitude: > 0.02%
Light penetration: > 5%
Accuracy: ±2%
Data update rate
≤2s
*SpO
2
accuracy was determined by testing on healthy adult volunteers in the range of 60% to
100% SpO
2
against a laboratory CO-Oximeter. SpO
2
accuracy was determined on 16 neonatal
NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-
nine (79) data samples were collected over range of 70-100% SaO
2
with a resultant accuracy of
2.9% SpO
2
.
The following table shows the accuracy (A
rms
) for the SpO
2
sensors in four kinds of SaO
2
ranges.
For the Fitting Curve of the SpO
2
sensors, refer to A.8.3.2 Fitting Curve for Masimo SpO2
Sensors .
SaO
2
range
Measured A
rms
Values
LNCS Adtx, LNCS Pdtx, RD
SET Adt, RD SET PDT LNCS DCI, LNCS DCIP, RD
SET DCI(Adult&Pediatric)
70% to 100% ± 2% 2%
70% to 80% 1.55% 0.60%
80% to 90% 1.07% 0.54%
90% to 100% 1.64% 0.60%
PR
Measurement range
25 bpm to 240 bpm
Resolution
1 bpm