Fukuda Denshi LX-8000 Series, Operation Manual

Page: 105 / 110

15. Specification
81
Heart rate
meter accuracy
and response
to irregular
rhythm: 80 bpm Ventricular Bigeminy: 80 bpm
60 bpm Ventricular Bigeminy: 60 bpm
120 bpm Ventricular Bigeminy: 120 bpm
90 bpm Bidirectional Systoles: 90 bpm
Respiration (Impedance Method)
Accuracy of Sensitivity: 10 mm/1 Ω ± 2 mm
(When standard Impedance is 480 Ω .)
Resp. Display Range: 0, 4 Bpm to 150 Bpm
Display Error of
Respiration Rate: ±3 Bpm
Measured Current of
Respiration:
Below 100

A (42kHz)
SpO
2
NOTE
About the SpO
2
Clinical Test
The SpO
2
and pulse rate measurement accuracy have been validated for
each range by testing on healthy adult male and female volunteers against a
laboratory CO-Oximeter.
The SpO
2
accuracy has been validated for the range from 70% to 100% by
testing on healthy adult male and female volunteers with light to dark skin
pigmentation. Without body motion, the standard deviation is ±2% which
encompasses 68% of the population. With body motion, the standard
deviation is ±3% which encompasses 68% of the population. For the
validation, frictional or contact motion of 1 cm to 2 cm, and random vibration
of 1 Hz to 5 Hz were tested.
The pulse rate accuracy has been validated for the range from 70% to 100%
by testing on healthy adult male and female volunteers with light to dark skin
pigmentation The standard deviation is ±3 bpm which encompasses 68% of
the population.
These clinical test data are disclosed based on the data provided from
Masimo.