Passport® - Mindray

Appendix Performance Characteristics
No motion conditions 1 :
PATIENT SIZE
70% TO 100% 50% TO 69% 1-49%
Adult Mode ± 2% ± 3% unspecified
Pediatric Mode ± 2% ± 3% unspecified
Neonatal Mode ± 3% ± 3% unspecified
During motion conditions 2 :
1 Masimo SET technology with LNOP and LNCS sensors have been validated for no motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a
laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation, which
encompasses 68% of the population.
2 Masimo SET technology with LNOP and LNCS sensors have 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 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an
amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation, which encompasses
68% of the population.
Resolution
1%
Average Time
Optional 2-4 seconds, 4-6 seconds, 8 seconds, 10 seconds, 12 seconds, 14 seconds,
16seconds
Refresh Rate
1s
SpO 2 Response Time
The response time is 18 seconds to 95% of final step change of % SpO2 value from 60 to
95% at 75 bpm. Post averaging time is set at 8 seconds.
Sensitivity
SATURATION RANGE
SATURATION RANGE
PATIENT SIZE
70% TO 100% 1-69%
Adult Mode ± 3% unspecified
Pediatric Mode ± 3% unspecified
Neonatal Mode ± 3% unspecified
Normal and high sensitivity modes are optional. The sensitivity mode affects the
measurement of dim signals.
Passport V Operating Instructions 0070-10-0704-02 19 - 17