Seca mVSA 535 - Description of Device; Intended Use for the Seca Mvsa 535; Intended Use for the Seca Mbca 525

6 • secamVSA 535/seca mBCA 525
17-10-05-353-002g_10-2020 B
2. DESCRIPTION OF DEVICE
2.1 Intended use for the seca mVSA 535
The medical Vital Signs Analyzer secamVSA 535 is mainly used in inpatient
facilities (hospitals, medical practices and care facilities) in accordance with
national regulations.
The medical Vital Signs Analyzer
secamVSA 535 is used for non-invasive, dis-
continuous determination of arterial blood pressure and/or non-invasive
determination of oxygen saturation of arterial hemoglobin and/or determina-
tion of body temperature and pulse rate and determination of weight and
height.
When the Bioimpedance analysis function is included, the medical device is
also used to record bioelectric impedance measurements and to calculate
automatically parameters such as fat-free mass (FFM) which can be derived
from these measurements. The results are displayed in graphical form and
assist the attending physician with the following medical 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
The medical Vital Signs Analyzer
secamVSA 535 is intended for use in chil-
dren 3 years and older and adults. The Bioimpedance analysis function is not
intended for use on children.
2.2 Intended use for the seca mBCA 525
The medical Body Composition Analyzer seca mBCA 525 is mainly used in
inpatient facilities (hospitals, medical practices and care facilities) in accor-
dance with national regulations.
The medical Body Composition Analyzer
seca mBCA 525 records weight,
height and bioelectric impedance measurements and automatically calculates
parameters such as fat-free mass (FFM) which can be derived from these
measurements. The results are displayed in graphical form and assist the
attending physician with the following medical 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
The device is not intended for use on children.
➔ Intended use for the seca mVSA 535
➔ Intended use for the seca mBCA 525
➔ Description of function
➔ User qualification
➔ Contraindications