| Specifications of the device |
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| Type of device |
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| EIS System is a Programmed Electro
Medical System (PEMS) which includes: |
- Hardware device including black box, 6
tactile electrodes and cables
- Software installed on a computer
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| The device is connected to computer
through USB cable. |
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| Indications for use |
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| There are 3 types of indications for use: |
- EIS System is a non-invasive bio impedance analyzer used for measurement of actual height, actual weight and estimated body composition and lifestyle. The applicable age range is 10 to 80 years for sedentary subjects. For
sportive subjects, the applicable range is 16 to 60 years.
- The system can be programmed to compute
various physiologic or blood flow parameters and within the
clinical context aid to regulate target supplementary
examinations. The applicable age range is 5 to 80 years.
- EIS system is used for the therapeutic
follow up. The applicable age range is 5 to 80 years.
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| Purpose and function of the device |
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The device records the intensity of body volumes (volumes ranging between the 2 electrodes passive and activates) following the sending of an imposed tension of 1.28V on an electrode.
This intensity is transmitted via USB port to software installed
in the computer. The software records various parameters and
provides reports. |
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| The software
will have as a function to treat this intensity: |
- In resistance and conductivity
- To make the calculation of fat mass, Total
Water Body (TWB) and lean mass.
- To model the human body and to locate the organs
- To allot a value of conductivity to various organs
- To establish the link between conductivity and certain physiologic parameters
- To establish with a statistic program (Statistica version 7.0) an analysis of probability of the functional risk of the patient according to the international classification of WHO
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| Intended Use |
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| Device claims or performance |
- Analyzer body composition
- Compute various physiologic parameters in certain organs
- Statistical analysis of the functional risk of the various body systems
- To control the effectiveness of the treatments managed to cure or attenuate an organic dysfunction or a disease
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| Cost of the examination : |
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| The frontal electrodes are disposable and cost about 1$ per examination. This examination is performed in the doctor's office or the functional department of a hospital or clinic. The price will take into account the price of frontal electrodes, amortization of the purchase of equipment and the moderate fees charged by the physician producing the interpretation and report. |
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| Latrogenic undesirable side effects : |
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| No iatrogenic side effects or adverse reactions are known to date |
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| Contraindications : |
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Contra indications are impossibilities in taking the measurement or in interpretation.
General contra indications |
- dermatological lesions in contact with the electrodes or excessive perspiration
- pacemakers
- People unable to be held upright or seated
- Metal pins or prostheses on the level of the extremities or the joints
- Pregnant women after the 6th month
- An absence of one or more limbs.
- The site of the system : the ground in synthetic material and a relative humidity < 30% can prevent measurement. The system is sensitive to the important electromagnetic discharges owing to the fact that it measures very low current.
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| Supplementary contraindication for analyzer body composition : |
- Fever
- Drugs
- Strong alcohol or stimulants (amphetamines) 12 hours before the examination
- Diarrhea
- Intense physical activity 8 hours before the examination
- Oedema
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