3D Body Scan is performed by ESTECK COMPLEX
NON INVASIVE HEALTH MONITORING SYSTEM |
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| ESTECK COMPLEX |
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(Functional diagnostics)
Manufacturer: LD Technology LLC, USA
Distributor: LD Healthcare Systems Corp.
USA: FDA 510K Clearance Class 2
Electro Sensor Teck Model PEMS1
Regulatory Class II 510 K 083229
21 CFR 870.2300
Canada: Class III
Europe: Class IIa
The ES TECK COMPLEX software runs with the 2 hardware models (PEMS or EIS-BC) |
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| Hardware Models and features: |
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| Model PEMS |
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Pulse Oximeter displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. The photoelectrical Plethysmograph’ feature (PP) analyzes the pulse waveform provided by the oximeter. The mathematical analyses provide estimated indicators of the vascular system. |
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HRV (Heart Rate Variability) evaluates the variation of the heart rate, 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 mathematical analyses of the measurement provide estimated indicators of the ANS (Autonomic Nervous System). |
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| Model EIS-BC |
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EIS (Electro Interstitial Scan) evaluates the conductivity of 22 parts of the human body in bipolar mode between 6 tactile electrodes using a direct current and by applying the following mathematical formulae: |
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Cottrell Equation: the software allows the estimation of interstitial electrolytes and interstitial acid base balance. |
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BIA: estimation of the interstitial fluid volume and the software’s calculations allows the estimation of the tissue Oxygen delivery and microcirculation pressure. |
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Venn diagram and Maxwell equation on the ESG values: the software calculates and provides a modeling of the human body which represents the interstitial fluid conductivity of the human body systems. |
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BC (Body composition) evaluates 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 body composition parameters (TWB, Fat Free mass, fat mass) according to the predictive equations of BIA (Body Index Analysis) issue from the peer reviews. |
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| Indications or Intended use |
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| According to the features: |
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| 1. EIS module: |
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Monitoring of diseases ‘ treatments |
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Adjunct to conventional diagnosis of ADHD children |
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| 2. BIA module: Calculation and Historical Tracking of: |
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Actual Impedance |
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Actual Phase Angle (PA) |
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Estimated Body Fat (FAT) |
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Estimated Fat Free Mass (FFM) |
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Estimated Total Body Water (TBW) |
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Estimated Intra-Cellular Water (ICW) |
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Estimated Extra-Cellular Water (ECW) |
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Estimated Basal Metabolic Rate (BMR) |
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Actual Body Mass Index (BMI) |
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| 3. Pulse Oximeter: |
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To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. |
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To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement which estimated vascular system’s indicators. |
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| 4. Heart rate variability (HRV): |
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To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability which estimated ANS (autonomic nervous system)’s indicators. |
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The software provides a visual alert for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The PEMS is intended use only for adult subjects (> 20 years old)
The BC is intended for use on healthy children (>10 years old), general and obese adult subjects.
The EIS will be used for children (> 5 years old) and adult patient.
EIS system is designed to monitor treatments for select diseases and as an adjunct to conventional diagnosis of ADHD children ( EC Mark Class IIa as a medical device in European, Asian, and South American and Australian marketplaces) |
