Welch Allyn Connex VSM 6000 series Directions For Use Manual page 235

Directions for use
Masimo specifications (for additional information, refer to the directions for use that
accompanies each accessory)
6
Accuracy
Resolution
RRa
Unit of measure
Body weight
Measurement range
7
Accuracy
Resolution
1
SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 60% to 100% SpO2 against a
laboratory CO-Oximeter. SpO2 accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days
old and weighing between 0.5 and 4.25 kg. Seventy-nine (79) data samples were collected over a range of 70% to 100%
SaO2 with a resultant accuracy of 2.9% SpO2. Contact Masimo for testing specifications.
2
The Masimo sensors have been validated for no-motion accuracy in human blood studies on healthy adult male and
female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70% to 100% SpO2
against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1 standard deviation which encompasses
68% of the population.
3
The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and
female volunteers with light to dark skin pigmentation 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% to 100% SpO2 against a laboratory CO-Oximeter and ECG monitor.
This variation equals ±1 standard deviation which encompasses 68% of the population.
4
The Masimo rainbow SET CO-Oximeter module has been validated for low-perfusion accuracy in bench-top testing
against a Fluke Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and
transmission of greater than 5% for saturations and pulse rates within the stated accuracy specifications. This variation
equals ±1 standard deviation which encompasses 68% of the population.
5
The Masimo sensors have been validated for pulse rate accuracy for the range of 25 to 240 beats per minute in bench-
top testing against a Biotek Index 2 simulator. This variation equals ±1 standard deviation which encompasses 68% of
the population.
6
SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to
dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals ±1
standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion
or low perfusion.
7
Respiration rate accuracy for the RRa sensor and instrument has been validated for the range of 4 to 70 breaths per
minute in bench-top testing. Clinical validation for up to 30 breaths per minute was also performed with the RRa sensor
and instrument.
Adults, Pediatrics (no motion): 8 to 17 g/dL ±1 g/dL
0.1 g/dL or mmol/L
breaths per minute
Adult >66 pounds (30 kilograms)
0 to 70 breaths per minute
Adults: 4 to 70 ±1 breath per minute
1 breath per minute
Specifications 229