EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual After Monitoring
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reference measured with a CO-oximeter. Pulse oximeter 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 composed of local healthy men and women from age 19 to 37, with variations
of skin pigmentations. The SpO
2
accuracy is as follows: ±2% for 90%-100% and ±4% for
70%-90%.
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 Generally, the quality of the SpO
2
pleth wave reflects the quality of the light signals
obtained by the sensor. A wave of poor quality manifests a decline of the signal validity.
On the other hand, the stability of the SpO
2
values also reflects the signal quality. Different
from varying SpO
2
readings caused by physiological factors, unstable SpO
2
readings are
resulted from the sensor’s receiving signals with interference. The problems mentioned
above may be caused by patient movement, wrong sensor placement or sensor
malfunction. To obtain valid SpO
2
readings, try to limit patient movement, check the
placement of the sensor, measure another site or replace the sensor.
8.2.5 SI (Signal Intensity)*
*Only applicable to the EDAN module
The signal intensity (SI) shows perfusion in numeric, and it reflects the pulse intensity of the
measurement site. The SI ranges from 0 to 10, with a larger value indicating the more intense signal.
When the SI value reaches 10, the signal quality is optimal. If the SI value is less than 2, it indicates
that the pulse at the current site is weak, and you should change the measurement site.
The SI value is displayed in the SpO
2
parameter area.
8.2.6 SpO
2
Relevant Data for Reference
1. The table below shows Arms values measured using with SH series sensors in a clinical study.
SaO
2
Range
Arms
With SH1
With SH4
90%-100%
1.01
1.29
80%-90%
2.01
2.17
70%-80%
2.01
2.29
70%-100%
1.68
1.89
2. The figures below show the Bland-Altman Plot of SaO
2
vs SpO
2
measured using SH series sensor.
In the plots, the upper and lower dotted lines represent the upper and inferior limits of the 95%
consistency, and the middle dotted line represents the average of the bias.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English