Welcome to. Xi an Libang Medical Electronics Co., Ltd.

Transcription

1 Welcome to Xi an Libang Medical Electronics Co., Ltd. 1

2 About Us Xi an Libang Medical Electronics Co., Ltd. was set up in June 09, We are engaged in non-invasive medical technology, research and development, production, sales and service in the high-tech medical electronic software enterprise. We are the subsidiary of Libang Healthcare Group, a nationally renown pharmaceutical corporation in China. We have an established R&D center in Xi'an and a production facility that is ISO13485 compliant. On May of 2014, we were granted a Class II Medical Devices Manufacture License. 2

3 WRIST AP Noninvasive Haemodynamic Monitor Model No.: BP100B 3

4 Front Panel: Waveforms; Trend Charts; Menu Rear Panel: Fan Vent; Machine Holder; Labeling; Equipotential Grounding Connector; DC Power ; Input Connector Monitor Left Side: SpO2 and NIBP; NIBP USB; Power Supply Right Side: IBP Output Connector; Network Connector; USB 4

5 Wrist Sensor The Wrist Unit is composed of Wrist Sensor, Cable and Fixation. 5

6 Wrist Pallet (Left & Right) Disposables Wrist Pad Positioning Pad 6

7 7

8 WristAP BP100B is a noninvasive monitoring system with a wrist sensor wrapped around the patient's wrist to monitor continuous blood pressure on the radial artery and to trend beat-to-beat haemodynamic parameters. WristAP BP100B Highlights: i Volume Clamp Methodology (or VUT) of Noninvasive Technique ii Wrist Radial Artery Continuous Measurement. iii The Pulse CO-Oximetry Method from USA Masimo Technology. 8

9 WristAP BP100B Principle: The volume is measured by a Photoplethysmography built into the Wrist Cuff, detecting the patient s wrist radial artery continuous blood pressure via the Sealed Air-inflated Bladder Pressurization, through Pulse Signal Processor to regulate vessel pressure, maintain the inside with outside of vascular pressure in a balance and unloading status, to produce a real-time, beat-to-beat arterial pressure value and waveform; that is: Continuous and Real Time Radial Artery Blood Pressure Value with Waveform. (Without the need for cuff/manual calibration or algorithm calculation. ) WristAP BP100B includes the Pulse CO-Oximetry method from USA MasimoRainbow SET Technology for measuring SpO2, PI, PVI, SpMet, SpHb, SpCO, PR and RRA. 9

10 WristAP BP100B Features: 1 Non-Invasive & Safe 2 Instantaneous & Continuous 3 No Calibration Required 4 Movement Resistant 5 Long Term Monitoring 6 High Accuracy For patients who require a fast and accurate but long duration monitoring wi continuous BP waveforms and beat-to-beat pressure values in any occasion for instance, in Emergency Department(ED), Operating Theatre(OR), Intensiv Care Unit (ICU), as well as Anesthesiology, etc. 10

11 Intellectual Property - Patents No.: EU ; US B2; HK ; ; X; X; X; ZL ; ZL ; ZL ; ZL

12 BP100B ---- CE Registration Certficate ISO13485 Quality Certificate 12

13 Fig.1 Comparison Between Noninvasive (BP100B) and Invasive (IBP) Measurement i A trend charts BP100B and IBP during anesthesia induction and endotracheal intubation ii The red wave represents IBP (Invasive) ; The blue wave represents BP100B (Noninvasive) iii It shows an an accurate agreement in BP100B compared with IBP during anesthesia induction & endotracheal intubaiton. Comparision between BP100B with IBP monitoring for the patient in vasomation states Anesthesia Induction Endotracheal Intubation Blue:SBP-MBP-DBP(BP100B) Red:SBP-MBP-DBP(IBP) 13

14 Fig. 2 Comparison BP100B with IBP measurement i The entire process of Intracranial Gliomas Resection Monitoring by BP100B with IBP ii The blue trend line represents: SBP MBP DBP measured by BP100B (noninvasive) The red or pink wave represents: SBP MBP DBP measured by IBP (invasive) iii The following figures shows that BP100B with IBP measurement has small bias and narrow limits of agreement are consistent over the whole range of values. The entire process of Intracranial Gliomas Resection Monitored by BP100B with IBP 14

15 Fig. 3 Linear regression analysis between BP100B and IBP of a whole period of craniotomy operation Linear regression analysis between BP100B and IBP of a whole period of craniotomy operation (number of paired BP obtained: n=17,273 ) demonstrated correlation coefficients of r = 0.948, and for paired systolic, diastolic and mean BP, respectively. 250 Diastolic NIBPw (mmhg) n= r = Systolic NIBPw ( mmhg) n = r= D iastolic IBP (m m Hg) Mean N IBPw (m mh g) n = r = Systolic IBP (mmhg) Mean IB P ( m m Hg) 15

16 Technology Overview on Current Blood Pressure Monitoring ØInvasive ( 1.1; 1.2; 1.3 ) ØNon-invasive ( 2.1; 2.2; ) 16

17 1.1 Invasive-Arterial Catheterization Monitoring for Critical Patients

18 1.2 The Advantage and Disadvantage of Invasive catheterization Continuous, but Invasive It is performed through the cannulization of a peripheral artery with a catheter and place cannula -Risk of bleeding, thrombosis, infection and nerve injury led by the arterial catherization to the patient Complexity, requiring skilled physician to place cannula appropriately. - Not fit for shock, obsetity, infants of whom are in weak pulse state to place cannula. High requirement on hospital operation, facility and environment - It can't be implemented in some departments of hospitals. Long-term catheterization will cause vascular obstruction - Long-term use in ICU may display error results.

19 1.3 The Deficiency of Invasive Catheterization Monitoring It applies to current surgery, intensive care unit (ICU) patients, including patients who must ungergo special examination and treatment but require obtaining Non-invasive and Continuous Blood Pressure Value. 19

20 2.1 Currently, Arm Cuff Blood Pressure Monitor is universally used for hospitals. 20

21 2.2 The Advantage and Disadvantage of Arm/Wrist Cuff Blood Pressure Monitor Non-invasive, but Intermittent It takes tens of seconds to obtain the Systolic (Top) BP value with the Diastolic (Bottom) BP value, and maybe inappropriate for long time and repeated pressurizing to measure for avoiding the arm congestion. It can t be utilized for the patients who are in greater and faster blood pressure variability state. In the light of pulse strength with the cuff pressure changing as well as the envelope curve shape to determine Systolic BP Value and Diastolic BP Value, the shape of envelop curve is designed for vascular elasticity. Greater measurement error in patients with hypertension & vascular diseases. Cuff Blood Pressure Monitor does not apply to shock patients with extremely weak pulse. The shock and critically ill patients blood pressure are often prone to measurement failures. 21

22 The NIBP (Non-invasive Blood Pressure) Monitor on The Market Applied on Wrist (Based on Tensammetry Methodology) Applied on Finger (Based on Volume Clamp Methodology) 1 Colin Japan JENTOW (US$ 18,800) Launched in FMS Nederland FINOMETER MIDI (US$ 41,988) FINOMETER PRO (US$ 57,057) PORTAPRES (US$ 67,481) Launched in Tensys US T-LINE TL-100 T-LINE TL-150 (US$ 42,500) T-LINE TL-200 T-LINE TL-300 T-LINE TL-400 Launched in Bmeye Nederland Nexfin Launched in CNSystems Austria CNAP Launched in

23 Analysis the significant deficiencies in the following monitors 1. Japan Colin Monitor ( 1.1; 1.2; I.3 ) 2. US Tensys Monitor ( 2.1; 2.2; 2.3 ) 3. Netherland FMS ( 3.1; 3.2; 3.3 ) 4. Netherland Bmeye ( 4.1) 5. Austria CNSystems ( 5.1) 23

24 1.1 Japan Colin Monitor Applied on Wrist (Based on Tensammetry Methodology) Deficiencies: ØThe measurement results have to calibrate for obtaining an accurate blood pressure value. Colin Calibration Method: ØColin adopts another cuff pressure sphygmomanometer for calibration. 24

25 1.2 Japan Colin Monitor Applied on Wrist (Based on Tensammetry Methodology) Deficiencies: ØThe measurement results have to calibrate for obtaining an accurate blood pressure value. ØColin adopts another cuff pressure sphygmomanometer for calibration. 用于手指的产品 Colin Calibration have problems: ( 基于 血管无载法 ) 荷兰 FMS 公司 1991~2006 年推出 FINOMETER MIDI (RMB 280,000) FINOMETER PRO (RMB 380,000) PORTAPRES (RMB 450,000) Ø To ensure 荷兰 Bmeye the 公司 accuracy of blood pressure measurement, it is frequently 2005~2007 required 年推出 to adopt the upper arm oscillometric measure Nexfin method, and it always be interrupted in each of wrist blood pressure monitoring process. ØAccuracy of continuous BP monitor depends on the accuracy of upper arm oscillometric BP measurement; 奥地利 CNSystems 公司 2005~2008 年推出 CNAP ØEspecially for shock patients, oscillometric method can t measure as failed calibration. 25

26 1.3 Japan Colin Monitor Applied on Wrist (Based on Tensammetry Methodology) Shortcomings: 1. The measurement results have to calibrate for obtaining an accurate blood pressure value. 2. Colin adopts another cuff pressure sphygmomanometer for calibration Colin Movement Tolerant: 3. Patients with dysphoria or with external force and result in the measuring interrupt. 26

27 2.1 US Tensys Monitor Applied on Wrist (Based on Tensammetry Methodology) US Tensys Calibration Method: Deficiencies: ØThe measurement results have to calibrate for obtaining an accurate blood pressure value. ØTensys utilizes body mass index (BMI, computed using height and weight) for calibration. ØColin adopts another cuff pressure sphygmomanometer for calibration. 27

28 2.2 US Tensys Monitor Applied on Wrist (Based on Tensammetry Methodology) Tensys Calibration have problems: Deficiencies: ØThe measurement results have to calibrate for obtaining an accurate blood pressure value. ØColin adopts another cuff pressure sphygmomanometer for calibration. ØTensys utilizes body mass index (BMI, computed using height and weight) for calibration. The functional relationship among BMI with BP calibration PP calculated =GAIN( BMI, PP raw ) x PP raw It may differ among individuals and result in continuous BP monitoring error. 28

29 2.3 US Tensys Monitor Applied on Wrist (Based on Tensammetry Methodology) Tensys Movement Tolerant: Deficiencies: ØThe measurement results have to calibrate for obtaining an accurate blood pressure value. ØTensys utilizes body mass index (BMI, computed using height and weight) for calibration. ØPatients with dysphoria or with external force and result in the measuring interrupt. 29

30 3.1 Netherland FMS Applied on Finger (Based on Volume Clamp Methodology) Shortcomings: Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration With upper arm cuff can measure the absolute value of BP Without upper arm cuff only measure the relative value of BP 30

31 3.2 Netherland FMS Applied on Finger (Based on Volume Clamp Methodology) Kurki found out with vasoconstriction drug injection, adopting Volume Clamp Method on fingers to get Mean BP value, which is differs significantly with Invasive measured Mean BP value. ( MBP is lower than 60mmHg) Shortcomings: Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration Measurement results are easily affected by peripheral vasomotor. Dorlas found out, with vessels constrict, adopting Volume Clamp Method on fingers to get Systolic BP value, which is differs greatly with upper arm oscillometric method. ( SYS is higher than 26mmHg.) 31

32 3.3 Netherland FMS Applied on Finger (Based on Volume Clamp Methodology) Shortcomings: 1 Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration ; 2 Measurement results are easily affected by peripheral vasomotor; 3 It s difficult to measure the patients with cold and shock state which results in fingers ischemia. 32

33 4.1 Netherland Bmeye Applied on Finger (Based on Volume Clamp Methodology) Shortcomings: 1 Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration ; 2 Measurement results are easily affected by peripheral vasomotor; 3 It is difficult to measure the patients with cold and shock state which results in fingers ischemia. 33

34 5.1 Austria CNSystems FMS applies two cuffs on two fingers: CNsystem adopts two cuffs on two fingers: Applied on Finger (Based on Volume Clamp Methodology) Defects: 1) Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration ; 2) Measurement results are easily affected by peripheral vasomotor; 3) It s difficult to measure the patients with cold and shock state which results in fingers ischemia; 4) Long time monitoring can adversely affect the blood circulation on fingers; therefore, two fingers should periodically alternate to measure during long time monitoring. 34

35 Comparison and Conclusion Applied on Wrist (Based on Tensammetry Methodology) Deficiencies: 1 )The measurement results have to calibrated for obtaining an accurate blood pressure value 2) Colin adopts another cuff pressure sphygmomanometer for calibration. 3) Tensys utilizes body mass index (BMI, computed using height and weight) for calibration. 4) Patients with dysphoria or with external force and result in the measuring interrupt. Applied on Finger (Based on Volume Clamp Methodology) Shortcomings: 1) Without calibration, it can obtain the finger BP value, but it differs greatly with the conventional approach-upper arm cuff BP calibration ; 2 ) Measurement results are easily affected by peripheral vasomotor; 3 ) It s difficult to measure the patients with cold and shock state which results in fingers ischemia; 4 Long time monitoring can adversely affect the blood circulation on fingers; therefore, two fingers should periodically alternate to measure during long time monitoring. Current products are still not able to meet the clinical needs, especially for ICU monitoring requirements. 35

36 WristAP BP100B Innovation Ø It improves upon the existing limitations of difficult and unreliable to demonstration of the systemic blood pressure. Ø It adopts local pressurization apparatus to exert pressure on Radial Artery with Ulnar Artery in peventing the affects of blood circulation and neuromechanism of measured locus. Ø It can be automatic to opt the optimum measured locus, as well as to hold the measured wrist in a fixed position, which is to ensure the exact measurement on Radial Artery. Ø It has new algorithms development to ensure the measuring precision and stability. 36

37 The following Chart is WristAP BP100B Comparison with Invasive Measurement Comparison Invasive - Arterial Catheterization WristAP BP100B Approach Requiring skilled physician to place cannula appropriately; it approximately takes minutes from sterilization to catheterization, even more than 1 hours for some special patients. The physician can easy fix wrist sensor apparatus, it can be completed within 2-3 minutes. Safety & Reliable Risk of bleeding, thrombosis, infection and nerve injury led by the arterial catherization to the patient is minimized. Non-invasive and safe; Wrist Sensor is mounted on the surface of the skin, no hurt to skin. Disposable Cost Applications The cost of artery puncture with the disposable pressure transducer of every measurement for patient is very high. It is for the operating theatre use only. BP100B greatly minimizes the cost of disposable supplies for patient and every measurement with a reasonable charge. It can be used for the Operation Room, ICU(Intensive Care Unit), Emergency and Ambulance etc. 37

38 The following chart is WristAP BP100B comparison with current international measurement methodology. It demonstrates BP100B selling point. No. Comparison Contents Measured on Wrist ( Tensammetry Methology) Measured on Finger (Volume Clamp Methology) WristAP BP100B ( Volume Clamp Methology +Wrist Radial Artery) 1 Competitors Name US Tensys Medical Austria CNAP Company Xi an Libang Medical Electronics Co., Ltd. 2 Measurement results with calibration technique for demonstration the real blood pressure(yes or No) Yes, without a manual method of calibration can't measure. Yes, some occasion. Measures on finger not need calibration, but measure on upper arm need calibration. No, without the need for calibration Movement resistant performance level ( poor, good or best) Influence vasomotion (Yes or No) Measure the patient in a state of shock with faint pulse and cold extremities ( Yes or No) Poor Good Best (We have developed a breakthrough and innovation system to improve the currently measurement approach.) Unknown Yes, it is vulnerable to It is insusceptible to influence vasomotion. influence vasomotion. No, It can't measure the patients in a state of shock. No, It can't measure the patients in a state of shock. Yes, BP100B can measure the patients in a state of shock with faint pulse and cold extremities. 6 7 Long time monitor ( Yes or No) Yes Yes, it can long time monitor, but it have to alternately used on fingers. Commercial Price US$ 62,500/Set US$ 93,750/Set Yes, BP100B can long time monitor. US$ 58,000/Set (Provide advanced measurement in an affordable price 38 for the clinical treatment).

39 WristAP BP100B - Social and Economic Benefits Ø This would be an improved alternative to the conventional cuff blood pressure monitor, providing reliable, continuous and beat to beat blood pressure value; to enhance the physician control capacity on the patients with the pathological condition; to minimize the risk for surgery. Ø Increased avoidance of the risk of artery cannulation, such as, a common complication of thrombosis and infection; and lessen the pain for the patients. Ø It mitigates the requirement of skillful physician to place catheter and can be used widely in small and medium hospitals to assist those physicians who don t have the professional artery puncture capacity, optimum to use the medical resources and to ease the imbalances phenomena on medical resources utilization. Ø It significantly minimizes the cost of disposable catheter supplies for patient and also greatly relieves the financial burden of the society. 39

40 WristAP Series - Major Applications of The Intended Products (1) Intensive Care WristAP Alternation Configuration Update Algorithms Suspension NIBP Monitor Plug-in NIBP Monitor Hemodynamics Monitor Continuous BP, PR Continuous BP, PR Continuous BP, PR, CO (Without IBP Monitor Scenario) Use for ED, Ambulance, Battlefield, ICU etc. (With BIP Monitor Scenario) Use for Anesthesiology, ICU Cardiovascular, Anesthesiology, ICU and ED Additional Modules Integrated Threeparameters Monitor Integrated Multiparameters Monitor Plug-in Multiparameters Monitor Continuous BP, PR, SpO2, ECG Continuous BP, PR, SpO2, ECG, Resp, Temp, IBP, PETCO2 Outpatient (Minor Surgery, Painless endoscopy) Specialized Hospital ( Plastic Surgery, Painless Fix Teeth) Anesthesiology, PACU, ICU 40

41 WristAP Series - Major Applications of The Intended Products (2) Examination and Diagnosis WristAP Utilize the Measured BP Waveform to Calculate With Ultrasonic to Monitor Cerebral Vascular With Multiparameter Physiological Monitor Central Aortic Pressure Wave Gain Index Arterial Elastic Index Cerebral Vascular Reserve Function Autonomic Regulation Assessment of Antihypertensive Drugs efficacy Cardiac Stress Assessment Renal Function Assessment Antihypertensive Drugs Assessment Arterial Disease Diagnosis Stroke Diagnosis on Hypertension Antihypertensive Drugs Assessment Predication Heart Attack with Sudden Death Cardiology Neurology Nephrology Endocrine Reflection Diabetic Neuropathy 41

42 WristAP BP100B Inventor Dr. Lu performing clinical testing in the operation room of the First Affiliated Hospital of NingXia Medical University. 42

43 Thanks for Your Time!!! Xi an Libang Medical Electronics Co., Ltd. Contact: Sarah Zeng Marketing & Sales Director Mobile/WeChat: Office Tel: Skype: med_ Website: 43