Seca mVSA 535 Instructions For Use Manual page 98

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 %).
98 •
seca mVSA 535
®
technology with Masimo sensors was validated on the test bench for the
value 70 %, accuracy ± 2 digits; actual value is between 68 %
2
Accuracy of Masimo SET
Measuring
90-100 %
80-90 %
70-80 %
70-100 %
Masimo Patent Information
Masimo Patents: www.masimo.com/patents.htm
No Implied License Statement
Possession or purchase of this device does not convey any express or
implied license to use the device with unauthorized sensors or cables which
would, alone or in combination with this device, fall within the scope of one or
more of the patents relating to this device.
DCI/DCIP sensors
®
Measured values
A
RMS
range
0.60 %
0.54 %
0.67 %
Total value
2 %