Chapter 12: Specifications
Pulse Oximeter for Sleep Screening Operation Manual
12-1
Equipment Classification
Type of Protection Against Electric shock:
Internally Powered
Mode of operation:
Continuous
Degree of Protection Against ingress of
Liquids:
IPX1, drip proof
Degree of Mobility:
Portable
Degree of Protection Against Electric Shock:
Type BF
Safety Requirements:
EN60601-1: 1990
Displays, Indicators, & keys
SpO
2
:
LED numeric display, 7.62 mm (0.30 inches) high
Pulse Rate:
LED numeric display, 7.62 mm (0.30 inches) high
Pulse Strength: Logarithmically scaled 8-segment LED bargraph
Low Battery
Indicator:
1 Segment LED
Keys:
x
On/Off key
F
PRINT key
SpO
2
Range:
0 - 99% Functional SpO
2
(1% increments)
Accuracy
1
:
±2 at 70 - 99% less than 70% is unspecified
Alarms:
None
Averaging:
4 pulse beat average
Display Response:
The display is to functional saturation.
Display Update Rate: 1 Hz (SpO
2
); 60 Hz (pulse strength)
Calibration:
Factory calibrated over the range of 70% to 100% SpO
2
using human
blood samples to functional saturation. Test methods available upon
request. No in-service calibration is required.
Sensor:
Red 660nm, 2.0 mW (typical)
Infrared 905 nm, 2.0 - 2.4 mW (typical)
1
Because pulse oximeter measurements are statistically distributed, only about two-thirds of
pulse oximeter equipment measurements can be expected to fall within the A
RMS
of the value
measured by the co-oximeter. The 3403 has been validated in human desaturation studies on 10
healthy adult volunteers. The study was conducted at oxygen concentrations evenly distributed
over an SaO
2
range of 70-100%.
Chapter 12: Specifications
