5 m i n u t e t e s t. fda 510k electro sensor oxi (eso) k102442 product code dqa eis-gs k102166....

16
5 M I N U T E T E S T

Upload: tamsin-hubbard

Post on 26-Dec-2015

220 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Page 2: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Page 3: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNWBP08A K110774. Product code: DXN

Regulation

ISO 13485 Certified

5 M I N

U T E T E S T

Page 4: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Evaluation of patient’s risk factors using combination of devices managed by software with high level of signal processing analysis . 1. Small , medium and large artery stiffness and

hemodynamics evaluation using the photoelectrical plethysmography

2. Capillary stiffness evaluation using the electrical stimulation of the post sympathetic cholinergic system (GSR)

3. Blood pressure measurements 4. ANS evaluation using heart rate variability analysis and

Edwing tests 5. Body Composition evaluation using the bioelectrical

impedance

MD BioScan System

Page 5: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Presents a simple and painless test using advanced bio impedance, heart variability and digital pulse analysis evaluation. This four-minute screening is safe, non-invasive and provides valuable health status data. The objective test reports help address the following and more:• Health risks & Health status• Cardiovascular Risk• Obesity, Diabetes & Hypertension• Nutritional deficiencies

Painless test conducted relaxed in chair Evidence based results can be used as functional markers related to recommended clinical and lifestyle changes Provides health promotion wellness incentive model with health tracking

MD BioScan System

Page 6: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

MD BioScan System

Benefit to the

Employer

Non-Invasive tool for quick

employee investigation

Quick and easy to use

test in office in 5 minutes

Results immediately

available

Visual stimulation for better employee

compliancy

Follow up tracking and validation for

plan of treatment

Accepted by most major Insurance Carriers

Page 7: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

MD

BIOSCAN

SYSTEMUniversity of Miami, Miller School of Medicine Dr. John Lewis

Page 8: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

According to the clinical investigation carried out in University of Miami to compare the data of EIS-GS, ES-BC and ES Oxi to standardized techniques, the conclusion of the clinical investigator was:

“The ES Complex software managing the combination of the above devices will provide data that would be useful to help detect metabolic syndrome and its complications such as diabetes, and cardiovascular disease and non-invasively and rapidly manage treatment follow-up.”

University of Miami, Miller School of Medicine Dr. John Lewis

Page 9: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

DATA

Page 10: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Cardiovascular Score

Page 11: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Cardiovascular Screening

Page 12: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Diabetes Screening

Page 13: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Diet & Micro nutrition

Page 14: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Program Components

Clinical risk assessmentEarly detection testing & managementHealth risk tracking & reportingAction & health improvement planBehavior changeHealth and wellness coachingEmployee health outcomes and trackingEmployee/patient education and informationIncentive for health status improvement system

Page 15: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Page 16: 5 M I N U T E T E S T. FDA 510K Electro Sensor Oxi (ESO) K102442 Product Code DQA EIS-GS K102166. Product Code GZO ES-BC K103026. Product Code MNW BP08A

5 M I N

U T E T E S T

Group Analysis Report