Passport® - Mindray

Appendix Performance Characteristics
The LNOP ear sensors have an SPO2 accuracy of 70% to 100% ±3.5% for adults during no
motion conditions, however, since the monitor cannot display ½ digits, the accuracy rounded
to ±4 digits. The SPO2 accuracy during motion conditions is not specified for the LNOP ear
sensors.
LNOP & LNCS Sensors with MMS/MS-13/MS-11: Summary of Accuracy Validation (TR-
14864, DRO-22379, Revision C): With the exception of the LNOP Blue sensor and unless
otherwise noted in CSD-1109 or CSD-1110, the above sensors [LNOP & LNCS Sensors]
were clinically validated for motion and no motion conditions on healthy male and femaile
adults with light to dark skin pigmentation.
Sensor Measurement Wavelengths
The sensor measurement wavelengths are nominally 660 nm for the red LED and 940 nm for
the infrared LED. Maximum optical power output for the LEDs is 4 mW. This information may
be useful to clinicians, such as those performing photodynamic therapy.
19.8.6 DPM SpO 2 Performance Requirements
Measured Parameters
SpO 2, PR
SpO 2 Measurement Range
From 0 to 100%
Accuracy
PATIENT SIZE
70% TO 100% 0-69%
Adult Mode ± 2% ABS unspecified
Pediatric Mode ± 2% ABS unspecified
Neonatal Mode ± 3% ABS unspecified
Pulse Rate Range and Accuracy
Resolution
1%
Sensitivity
High, medium and low sensitivity are provided.
SATURATION RANGE
PATIENT SIZE PULSE RATE RANGE
ACCURACY
(NO MOTION CONDITIONS)
Adult / Pediatric / Neonate 20 to 254 bpm ± 3 digits
Passport V Operating Instructions 0070-10-0704-02 19 - 19