ES TECK COMPLEX SYSTEM

EC Mark Class IIa, Asian, and South American marketplaces.

ES Teck complex system Features
The ES Teck Complex system is a combination of 2 biosensor technologies with 5 features and signal processing analysis managed by software.
Bio impedance biosensor features:

1. The Bio Impedance in Bipolar Mode sensor (EIS sensor) feature evaluates the segmental conductivity of the human body with low frequencies via 6 tactile electrodes.  The signal processing analysis of the measurement provides estimated parameters related to tissue perfusion (Na+/K+ATPase pump activity (NAKA), tissue density) and cells metabolic needs.
2. The Bio Impedance in Tetra polar Mode (BIA sensor) feature evaluates the resistance and the reactance of the human body using a mono frequency (50KHz)  via 4 tactile electrodes, to estimate body composition parameters (TWB, Fat Free mass, fat mass) according to predictive equations as commonly seen in peer reviews.

Spectrophotometry biosensor features:

• The Pulse Oximeter (SpO2 sensor) displays SpO2%, pulse rate value and vertical bar graph pulse amplitude.
• The Photoelectrical Plethysmograph (PP sensor)’ feature is the signal processing analysis of the pulse waveform provided by the oximeter. The mathematical analyses provide indicators to estimate the cardiovascular function (Cardiac output, Stroke volume, Systemic vascular Resistance ….).  
• The Heart Rate Variability (HRV sensor) feature, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each QRS complex is detected and the so-called normal-to-normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are the result of sinus node depolarization. The signal processing analysis of the measurement provides indicators to estimate the ANS (Autonomic Nervous System) activity.

The goal of the combination of device is to estimate the homeostasis (internal medium and the mains regulatory mechanisms of the human body).


Indications or Intended use
In order to estimate the homeostasis process (internal environment and regulatory mechanisms) the ES Teck Complex provides estimation and Historical Tracking of the following intended uses:

1. To display Spo2 %
2. To analyze the basic rhythms of the NN or RR intervals in heart rate variability (HRV), both in the time domain and in the frequency domain (short time 5 minutes). It provides mathematical analyses of the input of the sinus node depolarization and ANS activity indicators*.
3. To analyze the pulse waveform by photoelectric plethysmography (PP), the second derivative of the photoelectric plethysmography and Pulse rate (short time 2 minutes). It provides mathematical analyses of the input of the SpO2% measurement and hemodynamic indicators**. 
4. To analyze the Galvanic skin responses (EIS) .It provides mathematical analysis of the bio impedance measurement and state of the connective tissue of some organs. ***.
5. Estimated body composition parameters (BIA). ****

The BIA is intended for use on healthy children (over 10 years), and general adult subjects.
The EIS will be used for children (over 5 years) and adult patients.
The HRV and PP will be used only for adult patients (over 20 years).
The device is not intended for use in continuous monitoring.
The system will be used by practitioners.

* ANS Mains indicators: sympathetic system activity (LF), parasympathetic system activity (HF)
**Hemodynamic indicators: Cardiac output (Q), Stroke Volume (SV), Systemic Vascular resistance (SVR) and Blood Volume (BV).
***Mitochondrial activity, Cells metabolic needs , and tissue density .
**** Mains parameters: Fat Free Mass (FFM), Fat Mass (FM), Total Water body (TWB), Extracellular Water (ECW) and Intracellular Water (ICW).  

> Screen Shoots