Clinical Studies; Accuracy Of Predictive Formulas; Vital Signs Measurement; Blood Pressure Measurement - Seca mVSA 535 Instructions For Use Manual

Clinical studies

Accuracy of predictive formulas

Ethnicity: Caucasian
Parameter
FFM
TBW
ECW
SMM
left arm
SMM
right arm
SMM
left leg
SMM
right leg
SMM
total
VAT
a. In the USA, a study was conducted on 130 healthy adults of different ethnicities. The aim of the study was to validate the param-
eters determined using seca formulas against clinically established reference methods. The results of this comparative study are
shown in the table above. The table shows the standard deviation (SEE) by ethnicity for the parameters determined using seca's
in-house formulas.

10.5 Vital signs measurement

Blood pressure measurement

Measuring method
Initial cuff pressure, downward measurement
Maximum cuff pressure
96 • /
seca mVSA 535 seca mBCA 525
Clinical studies form the scientific basis for analysis of body composition with
the mVSA
are incorporated in the device software in the form of reference values.
For some analysis parameters, the reference used depends on the patient's
ethnicity. The device automatically uses ethnicity-dependent references to
suit the corresponding entry in the seca patient file ➔
patient
Standard deviation (SEE) for predictive formulas in this device
Afro-American
SEE SEE
2.50 kg 2.21 kg
2.0 l
1.1 l
0.19 kg 0.28 kg
0.22 kg 0.30 kg
0.81 kg 0.71 kg
0.68 kg 0.66 kg
1.8 kg
0.5 l
➔
Blood pressure measurement
➔
COVIDIEN
➔
Masimo SET
➔
SpO
seca blood pressure module
and the mBCA
seca mVSA 535
file.
Asian
SEE
2.54 kg
1.8 l 1.4 l
0.9 l 0.9 l
0.19 kg
0.21 kg
0.81 kg
0.76 kg
2.0 kg 1.7 kg
0.6 l 0.6 l
TM TM
FILAC 3000 temperature measurement
®
SpO measurement
2
measurement seca
2
. The study results
seca mBCA 525
Preparing a seca
a
South and Central
American
SEE
2.62 kg
1.4 l
0.7 l
0.16 kg
0.17 kg
0.83 kg
0.71 kg
1.7 kg
1.2 l
Oscillometric, possible to switch
between upward and downward
measurement, possible to switch
between single and multiple
measurement (3 measurements)
Can be set: 80 mmHg - 280 mmHg
(260 mmHg cannot be set)
Other
SEE
2.49 kg
1.7 l
0.9 l
0.21 kg
0.23 kg
0.79 kg
0.70 kg
1.8 kg
0.8 l
300 mmHg