Welch Allyn VSM 6000 series Directions For Use Manual page 102

96 Specifications
SureTemp Plus temperature module specifications
Standard deviation
Braun ThermoScan PRO 4000 thermometer specifications (refer to manufacturer's
directions for use for additional information)
Temperature range
Calibration accuracy
Display resolution
SpO2 specifications (refer to sensor manufacturer's directions for use for
additional information)
SpO2 performance measurement range
Masimo sensor accuracy guide
Perfusion
Pulse rate
Saturation
Note
Nellcor sensor accuracy guide
Perfusion
Pulse rate
Does not exceed 0.5°F for oral, axillary, and rectal modes
68°F to 108°F (20°C to 42.2°C)
• ±0.4°F (±0.2°C) for temperatures ranging from 95.9°F to 107.6°F
(35.5°C to 42°C)
• ±0.5°F (±0.25°C) for temperatures outside of this range
0.1°F or °C
Saturation accuracy varies by
sensor type.
Welch Allyn Vital Signs Monitor 6000 Series™
1 to 100%
Accuracy specified when used with Masimo SET pulse
oximetry monitors or with licensed Masimo SET pulse
oximetry modules Masimo sensor accuracy guide
using PC series patient cables, during no motion.
Numbers present ± 1standard deviation. Plus or minus
one standard deviation represents 68% of the
population.
0.02 % to 20 %
25 to 240 beats per minute (bpm)
No motion: ± 3 digits
Motion: ± 5 digits
70% to 100%
Adults, Pediatrics (No motion): ± 2 digits
Neonates (No motion): ± 3 digits
Adults, Pediatrics, Neonates (Motion): ± 3 digits
Low Perfusion: 0.02 % to 20 % ± 2 digits
SpO2 measurement accuracy can only be evaluated in
vivo by comparing pulse oximeter readings with SaO2
measurements obtained from simultaneously sampled
arterial blood made using a laboratory CO-oximeter.
The VSM 6000 SpO2 accuracy was validated through
breathe-down-equivalent testing by Covidien using
electronic measurements to prove equivalence to the
Nellcor N600x predicate device. The Nellcor N600x
predicate device was validated by performing human-
subject, "breathe-down" clinical trials.
0.03 % to 20 %
20 to 250 beats per minute (bpm) ± 3 digits