Device description • 3
1. DEVICE DESCRIPTION
1.1 Intended use
The medical Body Composition Analyzer seca 515/514 is mainly used in
hospitals, medical practices and inpatient care facilities in accordance with
national regulations. The
seca 515/514 device records weight, height and bio-
electric impedance measurements and parameters, e.g. fat-free mass (FFM),
which can be derived from them for automatic calculation. The results are dis-
played graphically and assist the attending physician with the following medi-
cal issues:
• determining energy expenditure and energy reserves as a basis for
nutritional advice
• assessing metabolic activity and the success of a training program, e.g.
within the framework of rehabilitation or physiotherapy
• determining a patient's fluids status
• determining general state of health or, in the case of a previously-known
disease, assessing its severity
The
seca 515/514 is not a diagnostic device. To make an accurate diagnosis,
the physician needs to commission thorough examinations and take their
results into account in addition to the results of the
seca 515/514.
1.2 Description of function
Calculating weight and height The device uses an electronic scale. Weight is recorded across 4 load cells.
Height is recorded via manual entry or via wireless transmission from a
seca 360° stadiometer.
Bioimpedance measurement Bioimpedance is measured according to the 8-point method. The flow of the
low alternating current and the measurement of impedance are performed for
each side of the body using a pair of foot electrodes and 3 pairs of hand elec-
trodes. The hand electrodes are attached at different heights so that persons
with a height of between 1.60 m and 2.0 m can adopt the ideal position on
the device for a bioimpedance measurement.
Administering patient data seca patient files can be created directly on the device for administering mea-
sured results. The seca patient files are stored in the patient database of the
seca analytics 115 PC software supplied. Alternatively, seca patient files can
be saved on the USB memory stick supplied. The USB memory stick likewise
contains a seca patient database.
seca patient files and seca patient databases contain exclusively data neces-
sary for working with seca products or determined using seca products. seca
patient files can be administered and edited only using the
seca 115 PC
software. The export and import functions of the
seca 115 PC software can
be used for exchanging data with surgery and hospital information systems.
Evaluation Bioimpedance measurements are evaluated in graphical form based on sci-
entifically-established formulas. An in-house study by seca established formu-
las for determining the parameters of total body water (TBW), extracellular
water (ECW), fat-free mass (FFM) and skeletal muscle mass (SMM) for arms,
legs, torso and the whole body. In the same studies, in-house reference val-
ues were determined for the following parameters, in order to allow normal
ranges to be shown: bioelectric impedance vector analysis (BIVA), mass indi-
ces (FMI, FFMI), phase angle (φ). You can find further information in the
Instructions for Use for Physicians and Assistants.
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