Device Dossier
Measuring instrument, impedance
Device Dossier for Measuring instrument, impedance (Measuring instrument, impedance, Class IIa, sponsor Fresenius Medical Care). ARTG record, intended…
- GMDN category: Measuring instrument, impedance
- Sponsor: Fresenius Medical Care
Intended purpose
The Body Composition Monitor (BCM) assists the physician in assessing the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. The device also determines the nutritional status of the patient by continuously monitoring the body composition and permits determination of the urea distribution volume to calculate the dialysis dose (Kt/V) specifically for the area of renal replacement therapy. The BCM is intended for screening and monitoring of all individuals. The device is specified by the manufacturer for operation in professional health care facilities.