Seca mVSA 535 Instructions For Use Manual page 127

IEC 60601-1: Medical electrical device, type BF
a.The accuracy of the Masimo SET
with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation in the range from 70
– 100 % for SpO compared to a laboratory CO oximeter and ECG monitor. This fluctuation corresponds to ± 1 standard
2
deviation. Plus or minus one standard deviation covers 68 % of the population.
b.The accuracy of the Masimo SET
with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation, 2 to 4 Hz rubbing and
tapping movements being performed at an amplitude of 1 to 2 cm and a non-repetitive movement being performed at 1 to
5 Hz at an amplitude of 2 to 3 cm in the range from 70 – 100 % for SpO
monitor. This fluctuation corresponds to ± 1 standard deviation and thus covers 68 % of the population.
c.The accuracy of the Masimo SET
Biotek Index 2™ simulator and the Masimo simulator with signal strengths of over 0.02 % and a transmission of over 5 % for
saturations in the range from 70 to 100 %. This fluctuation corresponds to ± 1 standard deviation. Plus or minus one standard
deviation covers 68 % of the population.
d.The accuracy of the pulse rate of the Masimo SET
range 25 -240 min-1 compared to a Biotek Index 2™ simulator. This fluctuation corresponds to ± 1 standard deviation. Plus
or minus one standard deviation covers 68 % of the population.
e.The precise data can be found in the directions for use (DFU) for the sensors. Unless otherwise stated, the measuring position
for reusable sensors should be changed at least every 4 hours and for adhesive sensors, at least every 8 hours.
f.The sensor accuracy quoted applies in conjunction with the Masimo technology with a Masimo patient cable used for LNOP
sensors, RD SET sensors, the LNCS sensors or the M-LNCS sensors. The numbers stand for ARMS (accuracy root mean
square). Because pulse oximeter measurements are statistically distributed measuring procedures, only about two-thirds of
the measurements are expected to be in a range of ± ARMS compared to the reference value. Unless stated otherwise,
accuracy for SpO of 70 % to 100 % is quoted. The accuracy of pulse rate is quoted from 25 to 240 min-1.
2
g. Masimo M-LNCS, LNOP, RD SET, and LNCS sensor types have the same optical and electrical properties and may differ
only in application type (adhesive/non-adhesive/hook & loop), cable lengths, optical component locations (top or bottom of
sensor as aligned with cable), adhesive material type/size, and connector type (LNOP 8-pin modular plug, RD 15-pin modular
plug, LNCS 9-pin, cable-based, and M-LNCS 15-pin, cable-based). All sensor accuracy information and sensor application
instructions are provided with the associated sensor directions for use.
h.Digit: Numerical value by which the last place of a value displayed can deviate from the actual measured value; used to state
the accuracy of a measuring device (example: displayed SpO
and 72 %).
Masimo SET SpO
®
2
®
technology with Masimo sensors was validated with no movement in human blood studies
®
technology with Masimo sensors was validated with movement in human blood studies
®
technology in the case of poor perfusion was validated on the test bench compared to a
®
technology with Masimo sensors was validated on the test bench for the
2
Accuracy of Masimo SET
Masimo Patent Information
Masimo Patents: www.masimo.com/patents.htm
a b c d e f g
module
compared to a laboratory CO oximeter and ECG
2
value 70 %, accuracy ± 2 digits; actual value is between 68 %
DCI/DCIP sensors
®
Measured values
Measuring
range
90-100 %
80-90 %
70-80 %
Total value
70-100 %
English
A
RMS
0.60 %
0.54 %
0.67 %
2 %
Technical data • 127