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EIS-BC SYSTEM

EC Marks Class II a as a medical device in European marketplace
The EIS/BC is composed of 2 modules in 1 box with specific features managed by unique software:

1. The EIS (Electro Interstitial Scan) Bioimpedance very low frequency in bipolar mode to estimate the stress level from the spectral analysis of the body resistance/conductivity.
2. The BC (Body composition) module measures the resistance and the reactance in tetra polar mode between the right hand and right foot with a mono frequency of 50 KHz. The resistance and reactance calculate will be converting in estimated body composition parameters (TWB, Fat Free mass, fat mass) according to the predictive equations of BIA (Body Impedance Analysis) issue from the peer reviews.

>Intended uses.
1.Estimation of the stress level
2.Calculation and Historical Tracking of:
-Actual Impedance
-Actual Phase Angle (PA)
-Estimated Body Fat (FAT)
-Estimated Fat Free Mass (FFM)
-Estimated Total Body Water (TBW)
-Estimated Intra-Cellular Water (ICW)
-Estimated Extra-Cellular Water (ECW)
-Estimated Basal Metabolic Rate (BMR)
-Estimated Daily Energy Expenditure (DEE)
-Actual Body Mass Index (BMI)

The data are stored in PC in the Backup system of the EIS/BC software.
The device is intended for use on healthy children (over 10 years old), general and obese adult subjects (under 70 years old).
The device is intended use in licensed practitioner’s office and clinical environment
The system will be use by a practitioner.

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