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Directions for Use Chapter 6 Reference 57
Pulse oximetry (SpO
2
) specifications - Nellcor
SpO2 complies with EN ISO 9919:2005.
Characteristic Specification
Saturation (% SpO
2
)
Range
Resolution
Alarm Limits
a
With Acuity 6.0 or higher
With Acuity 5.4X or lower
a. SpO
2
alarm limit range depends on the software version of the Acuity System to which the monitor is connected.
1% to 100%
1%
50% to 99% (lower); 51% to 100% (upper)
80% to 99% (lower); 81% to 100% (upper)
Probe Accuracy
b
(Adults, Pediatrics)
b. Although some of the listed Nellcor sensors can be used with neonates with other pulse oximetry devices, the monitor is only intended
for use with adult and pediatric patients, not with neonates.
70% to 100% (0% to 69% unspecified)
OxiMax Max-A, Max-AL ±2 counts
OxiCliq N ±2.5 counts
D-YS ±3 counts
DS-100A ±3.5 counts
Pulse Rate
Range
Resolution
Alarm Limits
26 to 239 beats per minute
1 beat per minute
25 to 245 beats per minute (lower)
30 to 250 beats per minute (upper)
Pulse Rate Accuracy ±3 beats per minute
Display Update Interval at the monitor 1 second
Alarm Hold-Off Time Period 10 seconds; resets if the sensor reports levels within limits before 10
seconds elapses
Circuitry Microprocessor controlled
Automatic self-test of oximeter when powered on
Automatic setting of default parameters
Automatic alarm messages
Electrosurgery interference suppression Yes
Sensor Compatibility Compatible only with Nellcor sensors listed in the Micropaq monitor section
of the Welch Allyn Products and Accessories booklet (810-0409-XX).
For probe/sensor compliance to EN ISO 9919:2005, see the Nellcor directions
for use.
Sensor LED Wavelengths Within 500 to 1,000 nm
Sensor Energies (Radiant Power) Does not exceed 15 mW
WARNING Interfering Substances: Carboxyhemoglobin may erroneously
increase readings. The level of increase is approximately equal to the amount of
carboxyhemoglobin present. Dyes, or any substances containing dyes, that
change usual arterial pigmentation may cause erroneous readings.
WARNING Although the SpO
2
alarm limit range can be adjusted down to 50%
saturation (with Acuity 6.0 software or higher), the SpO
2
performance and
accuracy is not specified below 70%.