V Series Operating Instructions 29 - 39
Product Specifications Pulse Oximetry (SpO2) Performance
• Studies were performed to validate the accuracy of Pulse Oximeter with the SpO
2
sensors by
contrast with a CO-Oximeter.The clinical study enrolled 14 subjects, including four (4) male and
ten (10) female subjects. Among them, one is black male, one is black female, and the rest are
Asian race. All of test subjects are healthy adults. The average age of the 14 subjects is 26±3.14
years old. The average height of the male subjects is 67.81±0.44 inch. The average weight of the
male subjects is 149.54±13.58 pound. The average height of the female subjects is 63.27±0.54
inch. The average weight of the female subjects is 121.45±5.38 kg. The following table lists the
details.
3. Nellcor SpO
2
Performance Requirements
• Update Rate: Every 2 seconds
NOTE: The sensor wavelengths are nominal.
NOTE: The information about the wavelength range and maximum photic
output consumption can be especially useful to clinicians (for example,
when photodynamic therapy is performed).
• 660 nm for the red LED and 890 nm for the infrared LED.
• Maximum optical power output for the LEDs is 4 mW.
4. Nellcor SpO
2
Response Time
The response time is less than or equal to 30 s (PI > 0.3, no disturbance, SpO
2
value sudden change
within 70% - 100%)
5. Nellcor SpO
2
Heart Rate
For Adult, Pediatric, and Neonatal:
•SpO
2
heart rate resolution is 1BPM.
•Invalid SpO
2
heart rate data displayed as (- -)
6. Nellcor Sat Seconds
• Indicates the current status of the alarm graphically within the pie-chart icon.
• Fills in a clockwise direction when the monitor detects the SpO
2
value is outside the set alarm
limits.
• Empties in a counter-clockwise direction when the SpO
2
reading falls within the set alarm limits.
MALE (4 CASES) FEMALE (10 CASES)
Mean
Standard
deviation
Minimum
value
Maximum
value
Mean
Standard
deviation
Minimum
value
Maximum
value
Age
(year)
26.00 1.08 24.00 29.00 26.00 1.13 23.00 33.00
Height
(cm)
172.25 1.11 170.00 175.00 160.70 1.37 153.00 166.00
Weight
(kg)
67.83 6.16 52.30 80.00 55.09 2.44 44.90 72.00
RANGE ACCURACY
20 to 249 BPM ±3 BPM
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