LD TECHNOLOGY PRODUCT CATALOG

Transcription

1 LD TECHNOLOGY M A K I N G A D I F F E R E N C E EARLY DETECTION OF DIABETES COMPLICATIONS AUTONOMIC NERVOUS SYSTEM AND ARTERY ASSESSEMENT BLOOD PRESSURE AND ARTERIAL STIFFNESS ANALYSIS Monitoring and Treatment Management of Hypertension HEART RATE VARIABILITY (HRV) Cardiac Autonomic Dysfunction Assessment PHOTOPLETHYSMOGRAPHY Microcirculation disorders are the earlier stages of artery and Autonomic Nervous System complications CARDIAC AUTONOMIC REFLEX TESTS (CARTs) Cardiac Autonomic Neuropathy Assessment ANKLE BRACHIAL INDEX (ABI) Peripheral Artery Disease. Artery Blood Flow blockage or Calcification SUDOMOTOR FUNCTION TESTS Small Fiber Neuropathy Assessment LD TECHNOLOGY PRODUCT CATALOG

2 MAIN SYMPTOMS OF AUTONOMIC NERVE AND ARTERY DYSFUNCTION / DAMAGE Fatigue Headache Dizziness Exercice Intolarance Fainting Tingling in the Toes or Fingers Claudication Paintful muscle cramping in the hips, thighs or calves when walking, climbing stairs or exercising POPULATIONS THAT SHOULD BE TESTED WITH LD PRODUCTS Autonomic nerves and artery damage risk group in the USA Population over 50 years old with cardiovascular risk factors (Hypertensive, Overweight, Smoker, Diabetic) Everyone older than 70 OVER 45 MILLION PEOPLE EVERYONE IN THE RISK GROUP SHOULD BE MEASURED WITH LD PRODUCTS

3 TM-FLOW ARTERY / AUTONOMIC NERVES ARTERY ASSESSMENT AUTONOMIC NERVOUS SYSTEM ASSESSMENT LD-OXY OXIMETER FEET ELECTRODES TM-F l ow is focused on th e a u t o n o m i c n e r vo us s ys t e m a n d v a sc u la r sy st em f o r t h e ea r ly d etec t i o n a n d mo n i t o r i n g of com pl ication s res ul ting from chronic dis ea s e s, s uc h a s Di a b e t e s. PATIENT SETUP

4 TM-FLOW MARKERS ARTERY ASSESSMENT : ANS ASSESSMENT : Photoplethysmography (PTG) analysis Volume plethysmography analysis Second derivative PTG Pulse Wave Velocity (PWV) Peripheral Augmentation Index (paix) Central Aortic Systolic Pressure (CASP) Ankle Brachial Indices (ABI) Toe Brachial Index (TBI) Sudomotor markers Peak sweat gland blood flow and density Heart Rate Variability Analysis (HRV) Total Power, SDANN, LF, HF and LF/HF Cardiac Autonomic Reflex Tests (CARTs) Valsalva Ratio, E/I Ratio, K30/15 Ratio and Systolic blood pressure response difference while standing MICROCIRCULATION DISORDERS X PERIPHERAL ARTERY DISEASE X SUDOMOTOR DYSFUNCTION X CARDIAC AUTONOMIC NEUROPATHY BENEFITS OF TM-FLOW SYSTEM No Human Error Clear report Accurate Results (Simultaneous measurements) 7-10 min ANS and Artery Overview Combinaison of Technologies TM-FLOW is the only available medical device for assessing the Autonomic Nervous System and Arteries in one simultaneous exam. It helps the physician to distinguish the cause of neuropathic or vascular symptoms. Although the symptoms may imitate each other, it is imperative to distinguish between Autonomic Neuropathy and Artery Disease because the treatments are quite different. TM-FLOW performs accurate, simultaneous measurements that are based on established medical guidelines without any extrapolation of the results.

5 TM-FLOW TECHNICAL SPECIFICATIONS TM-FLOW is a Medical Device Data System (MDDS) which manages the SweatC, TM-ABI and LD-OXY Systems. FDA product code: OUG. Measuring principle SWEATC Galvanic skin response Voltage Intensity Measuring Range Maximum 1.28 V Maximum 200 ma SWEATC (a.k.a.sudoc) Galvanic Skin Response related to the sweat gland function. Measuring Accuracy The max mean deviation ± 3% 510k # k Power requirements Supply voltage 5V via USB port Measuring types Measuring ranges TM-ABI Ankle Brachial pressure index using volume plethysmography method for measuring systolic and diastolic pressure at arm and ankles. Pressure: 0 to 299 mmhg Heart rate 30 to 199 per min. TM-ABI Volume Plethysmography for assessing symtomatic peripheral artery disease. 510k # k LD-OXY SpO₂ Parameter Specification Measuring range 0%~100% (the resolution is 1%) Measuring range Photoplethysmography resolution: 100 ms Pulse Parameter Specification Measuring ranges 30 bpm ~ 250 bpm, (the resolution is 1bpm) LD-OXY Photoplethysmography analysis, HRV and CARTs analysis. 510k # k Accuracy ± 2bpm during the pulse rate range of 30 ~ 99bpm and 2% during pulse rate range of 100 ~ 250bpm

6 TM-ABI PLUS ARTERY PERIPHERAL ARTERY DISEASE ASSESSMENT The TM-ABI is the first valuable automated ankle-brachial index measuring system based on volume plethysmography for measuring blood pressure, ankle brachial and toe brachial index, arterial stiffness and central aortic Pressure. PATIENT SETUP

7 TM-ABI PLUS MARKERS ARTERY ASSESSMENT : Volume plethysmography analysis: Arm and Ankles Blood Pressure Pulse Wave Velocity (PWV) Peripheral Augmentation Index (paix) Central Aortic Systolic Pressure (CASP) Ankle Brachial Indices (ABI) Toe Brachial Index (TBI) PERIPHERAL ARTERY DISEASE BENEFITS OF TM-ABI PLUS No Human Error Clear report Accurate Results (Simultaneous measurements) 2-3 min ANS and Artery Overview Combinaison of Technologies TM-ABI PLUS detects all the markers of hypertension in addition to the Brachial Blood Pressure. The device provides Brachial and Ankle Arterial Stiffness and Central Aortic Systolic Pressure. ALLOWS NEW AND EFFECTIVE TREATMENT MANAGEMENT OF HYPERTENSION Best method to assess peripheral artery disease using: - Synchronization of the measurements arm-ankles - Blood pressure measurement from Photoplethysmography - Toe Brachial Index is a requirement to assess PAD in cases of ABI results >=1.4

8 TM-ABI PLUS TECHNICAL SPECIFICATIONS TM-ABI PLUS is a Medical Device Data System (MDDS) which manages the TM-ABI and LD-OXY Systems. FDA product code: OUG. TM-ABI Measuring types Measuring ranges Ankle Brachial pressure index using volume plethysmography method for measuring systolic and diastolic pressure at arm and ankles. Pressure: 0 to 299 mmhg Heart rate 30 to 199 per min. TM-ABI Volume Plethysmography for assessing symtomatic peripheral artery disease. 510k # k LD-OXY SpO₂ Parameter Specification Measuring range 0%~100% (the resolution is 1%) Measuring range Photoplethysmography resolution: 100 ms Pulse Parameter Specification Measuring ranges 30 bpm ~ 250 bpm, (the resolution is 1bpm) LD-OXY Photoplethysmography analysis, HRV and CARTs analysis. 510k # k Accuracy ± 2bpm during the pulse rate range of 30 ~ 99bpm and 2% during pulse rate range of 100 ~ 250bpm

9 ANS-1 AUTONOMIC NERVES AUTONOMIC NERVOUS SYSTEM ASSESSMENT OXIMETER FEET ELECTRODES ANS-1 system manages the Sudomotor test, Heart Rate Variability (HRV) Analysis at rest and during the Ewings tests in order to provide an overview of Automic nervous System. PATIENT SETUP

10 ANS-1 MARKERS ARTERY ASSESSMENT : ANS ASSESSMENT : Photoplethysmography (PTG) analysis Sudomotor function markers Conductance at anode and cathode following a DC stimulation Heart Rate Variability Analysis (HRV) Cardiac Autonomic Reflex Tests (CARTs) Valsalva Raio, E/I Ratio, K30/15 Ratio, Systolic response difference while standing MICROCIRCULATION DISORDERS X SUDOMOTOR DYSFUNCTION X CARDIAC AUTONOMIC NEUROPATHY BENEFITS OF ANS-1 No Human Error Clear report Accurate Results (Simultaneous measurements) 7-10 min ANS and Artery Overview ANS-1 System manages the Autonomic Nervous System battery of tests recommended by the American Academy of Neurology since 1996, and the Cardiovascular Autonomic Neuropathy Subcommittee of the Toronto Consensus Panel on Diabetic Neuropathy, for assessing the Autonomic Nervous System. Autonomic testing is recommended for all patients with type 2 diabetes at the time of the diagnosis, and 5 years after diagnosis in individuals with type 1 diabetes. ( Boulton et al., 2005;Tesfaye et al., 2010;Spallone et al., 2011; Bernardi et al.,2011.)

11 ANS-1 TECHNICAL SPECIFICATIONS ANS-1 is a Medical Device Data System (MDDS) which manages a unique Galvanic Skin response device, an oximeter and non-invasive blood pressure device. FDA product code: DXN, DQA, GZO and MNW. GALVANIC SKIN RESPONSE Measuring principle Galvanic skin response Measuring Range Voltage Intensity Maximum 1.28 V Maximum 200 ma Measuring Accuracy The max mean deviation ± 3% Power requirements Supply voltage 5V via USB port BLOOD PRESSURE DEVICE Measuring types Ankle Brachial pressure index using oscillometric method. Measuring ranges Pressure: 0 to 299 mmhg. ANS-1 SYSTEM Sudomotor function, HRV and CARTs Analysis and Photoplethysmography 510k # k OXIMETER SpO₂ Parameter Specification Measuring range Measuring range 0%~100% (the resolution is 1%) Photoplethysmography resolution: 100 ms Pulse Parameter Specification Measuring ranges Accuracy 30 bpm ~ 250 bpm, (the resolution is 1bpm) ± 2bpm during the pulse rate range of 30 ~ 99bpm and 2% during pulse rate range of 100 ~ 250bpm

12 LD TECHNOLOGY M A K I N G A D I F F E R E N C E LD TECHNOLOGY ISO CAMCAS FDA OWNER/OPERATOR NUMBER: FDA ESTABLISHMENT REGISTRATION NUMBER: CONTACT LD TECHNOLOGY ADDRESS 100 N. BISCAYNE BLVD, SUITE MIAMI, FLORIDA UNITED STATES