Welch Allyn 6000 Series Connex Vital Signs Monitor - User Manual User Manual
Page 208
Masimo specifications (for additional information, refer to the directions for use that
accompanies each accessory)
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.
CO2 specifications (for additional information, refer to the directions for use that accompanies
each accessory)
CO2 accuracy
1, 2, 3
0 to 38 mmHg: ±2 mmHg
39 to 150 mmHg: ±(5% of reading + 0.08% for every 1 mmHg
above 38 mmHg)
Flow rate
50 (42.5 ≤ flow ≤ 65) ml/min, flow measured by volume
Initialization time
40 seconds (typical, includes power-up and initialization
time)
System response time
3.2 seconds (typical, includes module response time and
host monitor system response time)
Compensation
The CO2 module is equipped with a barometric pressure
transducer and compensation is triggered at startup or
during other events (significant changes in temperature,
ambient pressure, etc.).
BTPS (standard correction used by Microstream capnography
during all measurement procedures for body temperature,
pressure, and saturation).
Cyclical pressure
≤
10 kPa (100 cmH
2
O); module operates within specification
with overpressure up to 100 cmH
2
O
202 Specifications
Welch Allyn Connex
®
Vital Signs Monitor 6000 Series™