Use Instructions

Vital Signs Monitor User Manual Monitoring SpO
2
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limit patient movement, check the placement of the sensor, measure another site or replace the
sensor.
NOTE:
1 The SpO
2
accuracy has been validated in controlled human studies against arterial
blood sample reference measured with a CO-oximeter. SpO
2
measurements are
statistically distributed, only about two-thirds of the measurements can be expected
to fall within the specified accuracy compared to CO-oximeter measurements. The
volunteer population in the studies are composed of healthy men and women from
age 19 to 37 (for EDAN SpO
2
module), with various skin pigmentations. Note that the
study population was healthy adults and not in the actual intended use population.
2 The pulse rate accuracy is obtained by comparison to the pulse rate generated with
an arterial oxygen simulator (also an electronic pulse simulator).
3 During monitoring, if the monitor's reading differs significantly from the patient's
physiological condition, it indicates that the signal may be disturbed, resulting in an
inaccurate reading. In this case, the artifact can disguise as a similar reading,
causing the monitor to fail to send an prompt. In order to ensure reliable monitoring, it
is necessary to regularly check whether the sensor is wearing properly and the signal
quality is good.
12.6 SpO
2
Prompt Delay
There is a delay between a physiological event at the measurement site and the corresponding
prompt at the monitor. This delay has two components:
The time between the occurrence of the physiological event and when this event is represented by
the displayed numerical values. This delay depends on the algorithmic processing time and the
sensitivity setting. The lower the sensitivity configured, the longer the time needed until the
numerical values reflect the physiological event.
12.7 Perfusion Index (PI)*
* Only applicable to the EDAN SpO
2
module.
PI is a numeric value indicating perfusion level. It reflects the perfusion level at the monitoring
site.
As the measurement of SpO
2
is based on the pulsation caused by the blood flow through the
vessel, PI is in relation to the strength of the pulse. Also, you can use PI as a signal quality
indicator for the measurement of SpO
2
.
PI is indicated by a value ranging from 0 to 10. The bigger the value is, the better the perfusion
and the signal quality will be. The perfusion level and the signal quality are at their maximum
when the value reaches 10. When PI is below 2, it indicates the low perfusion and the poor signal
quality at the monitoring site; you need to reposition the sensor or find a better site.
The PI value will be displayed in the SpO
2
parameter area.