医疗器械培训资料：Masimo - SET and RainbowSET Clawson09

1、 Confidential, for Internal Use Only 2009 Masimo Corporation Technological Breakthroughs Recognition of venous blood movement due to motion Motion/Low perfusion relationship Adaptive filters Parallel engines Innovative sensor technologies Confidential, for Internal Use Only 2009 Masimo Corporation N

2、oise Sensors - improved design (recessed detectors and extra shielding) shields from light and electrical noise interference Signal Processing - uses adaptive filters and parallel algorithms to distinguish between noise signals and arterial signals; reads 10X smaller pulse amplitudes Motion Electric

3、al Interference Light Patient cable improved design (extra shielding) shields from electrical and motion induced noise; transmits shielded signal to the monitor Masimo SET Improves Entire System Sensors, Cable, Software and Hardware Confidential, for Internal Use Only 2009 Masimo Corporation SET Imp

4、rovements Reduce Noise and Enable Highest Signal to Noise Ratio Confidential, for Internal Use Only 2009 Masimo Corporation Conventional 51:100-105. De Felice C, Latini G, Vacca P, Kopotic RJ. The pulse oximeter perfusion index as a predictor for high illness severity in neonates. Eur J Pediatr. 200

5、2;161:561-562. Hagar H, Church S, Mandadi G, Pulley D, Kurz A. The perfusion index measured by a pulse oximeter indicates pain stimuli in anesthetized volunteers. Anesthesiology. 2004;101:A514. Hager H, Reddy D, Kurz A. Perfusion index-a valuable tool to assess changes in peripheral perfusion caused

6、 by sevoflurane? Anesthesiology. 2003;99:A593. Hales JR, Stephens FR, Fawcett AA, et al. Observations on a new non-invasive monitor of skin blood flow. Clin Exp Pharmacol Physiol. 1989;16:403-415. Kakazu CZ, Chen BJ, Kwan WF. Masimo set technology using perfusion index is a sensitive indicator for e

7、pidural onset. Anesthesiology. 2005;103:A576. Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002;30:1210-1213. Uemura A, Yagihara M, Miyabe M. Pulse oxymeter perfusion index as a predict

8、or for the effect of pediatric epidural block. Anesthesiology. 2006;105:A1354. Confidential, for Internal Use Only 2009 Masimo Corporation PI vs. SIQ P ISIQ + +- -+ - Confidential, for Internal Use Only 2009 Masimo Corporation Confidential, for Internal Use Only 2009 Masimo Corporation The Challenge

9、 of Fluid Assessment Fluid administration is critical to optimizing patient status improve oxygen delivery by optimizing cardiac output Traditional methods to guide fluid administration often fail to predict fluid responsiveness Successful only 50-60% of the time Invasive methods are often impractic

10、al, complex, and costly Widespread clinical adoption is slow Noninvasive methods, to date, have been unreliable No single gold standard has emerged- Confidential, for Internal Use Only 2009 Masimo Corporation Pulse Oximeter Plethysmogram (POP) and the Perfusion Index (PI) The Pulse Oximeter Plethysm

11、ogram (POP waveform) Derived from the infrared light absorption Reveals information about peripheral perfusion Peripheral perfusion (PI) is related to the signal strength and quality of the pleth waveform Small changes in the POP waveform with associated changes in PI dynamically occur during a vent

12、ilatory cycle Large beat to beat changes in POP waveform (pleth variability) may occur during hypovolemia Fluid administration may decrease variability in patients who respond to a fluid challenge (intervention to increase pre-load)- Confidential, for Internal Use Only 2009 Masimo Corporation Which

13、curve is the pleth from the Oximeter? Confidential, for Internal Use Only 2009 Masimo Corporation Pulse Pressure Variation PP = PPmax- PPmin Correlation - Pulse Pressure Variation and changes in the POP waveform during Ventilation Pleth Waveform Variation POP =POPmax- POPmin Ventilatory Cycle Confid

14、ential, for Internal Use Only 2009 Masimo Corporation Calculation of PVI The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred PVI is a percentage from 1 to 100%: 1 - no pleth variability 100 - maximum pleth variab

15、ility Confidential, for Internal Use Only 2009 Masimo Corporation PVI Correlation with Pleth Changes Changes in pulse pressure may be visible on an arterial pressure waveform Changes in pulse volume may be visible on the pleth waveform Allows automated calculation and continuous monitoring of respir

16、atory variations in pulse oximeter waveform amplitude PVI ON features a PVI Pleth that includes and displays respiratory variations in the displayed pleth PVI OFF (or not loaded) features the traditional Masimo Radical-7 pleth that excludes respiratory variations. Confidential, for Internal Use Only

17、 2009 Masimo Corporation Pleth Variability Index (PVI) Pleth Variability Index (PVI) is a measure of the dynamic changes in PI that occur during a ventilation cycle PVI is a continuous measurement of changes in the plethysmographic waveform amplitude within a ventilatory cycle Beat to beat pleth amp

18、litude variations within a respiratory cycle related to fluid volume status 1,2 shown to be predictor of fluid responsiveness may be indicator of fluid volume status An elevated PVI that decreases and stabilizes with fluid administration may indicant fluid responsiveness Correlates with invasive pul

19、se pressure variation- 1Partridge BL. Use of pulse oximetry as a noninvasive indicator of intravascular volume status. J Clin Monit 1987;3(40): 263-8. 2Shamir M, Eidelman LA, et al. Pulse oximetry plethysmographic waveform during changes in blood volume. Br J Anaesth 1999;82(2): 178- 81. Confidentia

20、l, for Internal Use Only 2009 Masimo Corporation Clinical Applications Cannesson, et al, used hemodynamic data in association with PVI to assess the ability of PVI to predict fluid responsiveness recorded static and dynamic variables before and after volume expansion recorded PVI before and after vo

21、lume expansion patients who most often respond to fluid expansion demonstrated a reduction in PVI from a pre-volume expansion PVI levels of 14% to post expansions levels of 9% (high specificity and sensitivity). The prediction of fluid responsiveness by PVI is optimized in mechanically ventilated pa

22、tients during general anesthesia Continuous and noninvasive guide to assess fluid therapy Helps identify when to give fluid Helps know when to avoid giving fluid Aids clinician decision-making when fluid administration and/or blood transfusions are under consideration- Cannesson M. et al. Br J Anaes

23、th. 2008 Aug;101(2):200-6 Confidential, for Internal Use Only 2009 Masimo Corporation PVI changes may reflect disease states or physiology Cardiac causes Non-cardiac, non-pulmonary causes Pulmonary causes Cardiogenic shockHypovolemiaAsthma Cardiac tamponadeSeptic ShockTension pneumothorax Pericardia

24、l effusionAnaphylactic shock Constrictive pericarditisDiaphragmatic hernia Restrictive cardiomyopathySuperior vena cava obstruction Pulmonary embolism Extreme obesity Acute myocardial infarction Confidential, for Internal Use Only 2009 Masimo Corporation Summary: Clinical Utility of PVI PVI is a bre

25、akthrough measurement that helps clinicians noninvasively and continuously determine whether to administer fluid to patients. Fluid administration is critical to optimizing patient status Traditional methods to guide fluid administration are often unsuccessful1 Newer methods to improve fluid adminis

26、tration improve patient outcomes but are either impractical, invasive, or costly2 PVI is proven to predict fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery3 PVI may help clinicians optimize fluid administration and improve patient outcomes- 1 Michard F

27、, Teboul JL. Chest. 2002 Jun;121(6):2000-8. 2 Lopes MR, et.al., Critical Care 2007; 11: R100. 3 Cannesson M et al. Br J Anaesth. 2008 Aug;101(2):200-6. Confidential, for Internal Use Only 2009 Masimo Corporation APOD Adaptive Probe Off Detection Sensitivity Button APOD Indicator Confidential, for In

28、ternal Use Only 2009 Masimo Corporation APOD Confidential, for Internal Use Only 2009 Masimo Corporation APOD- Adaptive Probe Off Detection Percentage (%) Cold Start scenario, the sensor was left dangling and not connected to a patient before the oximeter was powered on. In the Warm Start scenario,

29、the sensor was removed from a human volunteer after monitoring had begun Confidential, for Internal Use Only 2009 Masimo Corporation Confidential, for Internal Use Only 2009 Masimo Corporation MAX Sensitivity Button MAX Indicator MAX Confidential, for Internal Use Only 2009 Masimo Corporation Max Co

30、nfidential, for Internal Use Only 2009 Masimo Corporation Learning Objectives Upon completing this course the participant will be able to: Describe hemoglobin and how it participates in oxygen transport Describe COHb and how even small amounts can be dangerous Describe MetHb and how it affects hemog

31、lobin Key Physiology and Laboratory Concepts Confidential, for Internal Use Only 2009 Masimo Corporation Hemoglobin Hemoglobin is a protein carried within the red blood cells. Responsible for carrying oxygen to the tissues. Four binding sites with Iron compound that binds to oxygen. Each hemoglobin

32、molecule can carry 4 oxygen molecules. Confidential, for Internal Use Only 2009 Masimo Corporation Oxyhemoglobin Deoxyhemoglobin Dyshemoglobins Carboxyhemoglobin Methemoglobin Sulfhemoglobin Sickle Cell Hemoglobin Genetically acquired hemoglobin abnormalities Hemoglobin - species Methemoglobin Oxyhe

33、moglobin Confidential, for Internal Use Only 2009 Masimo Corporation Oxyhemoglobin Dissociation Curve Left shift of the curve reduces the amount of oxygen delivered to the tissues Confidential, for Internal Use Only 2009 Masimo Corporation The Gold Standard for measuring parameters from a patients b

34、lood Blood Gas Machine Measures: Pa02, PaC02, pH CO-Oximeter Measures: COHb, MetHb, RHb and HbO2 Most every hospital has a blood gas machine, but some blood gas machines DO NOT have the CO- Oximetry module Blood Gas Machines with CO-Oximeters Radiometer OSM3 Instrumentation Lab, IL682 Confidential,

35、for Internal Use Only 2009 Masimo Corporation CO-Oximetry = Measured SaO2 (Typically around +/- 1% accuracy) No CO-Oximetry (including i-STAT devices) = Calculated SaO2 (no accuracy claim) Pulse oximetry accuracy typically +/- 2% Pulse oximetry should only be compared to CO-Oximetry. Therefore, All

36、Blood Gas Machines are Not Created Equal Confidential, for Internal Use Only 2009 Masimo Corporation Hemoglobin Confidential, for Internal Use Only 2009 Masimo Corporation Rainbow Platform Vision 2006, 2007, 2008 SpCO, SpMet, PVI Masimo SET Pulse Oximetry “Gold Standard” Read-Through Motion and Low

37、Perfusion SpO2, Pulse Rate, Perfusion Index, SIQ p l a t f o r m Current SpHb, PSN Future ARM, others Masimo Record of Innovation Confidential, for Internal Use Only 2009 Masimo Corporation The Sound Science of Rainbow Technology Oxygenated Hb and reduced Hb absorb different amounts of Red (RD) and

38、Infrared (IR) Light (Two-wavelength oximeters cannot measure dyshemoglobins) SpMet% SpCO% SpO2% R/IR (Conventional Pulse Oximetry) Confidence Based Arbitrator 0 50% 66% 97% 100% Post Processor Digitized, Filtered 1:233-43 Barret L, et al. Clin Toxicol. 1985;23:309-13 Grace TW, et al. JAMA. 1981;246:

39、1698-700 Confidential, for Internal Use Only 2009 Masimo Corporation High Risk Groups Patients at High Risk for Negative Outcomes Children Elderly Adults with cardiac disease Patients with decreased O2 carrying capacity (Anemia) Patients with chronic respiratory insufficiency Pregnant women, with em

40、phasis on fetal damage and death Cerebral palsy Limb and cranial deformities Mental disabilities Confidential, for Internal Use Only 2009 Masimo Corporation Fetal Damage Rucker J, Fisher J, Carbon Monoxide Poisoning, Chapter 63 Longo LD: The biological effects of carbon monoxide on the pregnant woma

41、n, fetus, and newborn infant. Am J Obstet Gynecol 1977;129: 69-103. Theoretical effect of different treatments on maternal and fetal COHb levels over time Confidential, for Internal Use Only 2009 Masimo Corporation Treatment of CO Poisoning Chemical Half-life of Carbon Monoxide bound to Hemoglobin 4

42、 hours on room air 45 minutes on 100% oxygen 22 minutes on 100% in Hyperbaric Chamber at 2-4 atmospheres Confidential, for Internal Use Only 2009 Masimo Corporation Red FDA Validation Masimo Rainbow SET Compared to Reference Methodology Noninvasive measurement provides clinically equivalent results

43、for HbCO without the need for invasive blood draw Excellent Precision and Accuracy Confidential, for Internal Use Only 2009 Masimo Corporation Oxyhemoglobin Confidential, for Internal Use Only 2009 Masimo Corporation Methemoglobin Confidential, for Internal Use Only 2009 Masimo Corporation Methemogl

44、obin A dysfunctional form of hemoglobin incapable of transporting oxygen, binds to water molecule instead Fe2 iron is oxidized to ferric state Fe3, causes entire Hb molecule to change conformation Confidential, for Internal Use Only 2009 Masimo Corporation Methemoglobinemia Oxidation occurs naturall

45、y in the body 1% MetHb is normal Primarily regulated by the cytochrome b-5 reductase enzymatic pathway Secondarily regulated by the NADPH methemoglobin reductase pathway Confidential, for Internal Use Only 2009 Masimo Corporation Methemoglobinemia: Congenital Type 1: - cytochrome b-5 reductase defic

46、iency - non-debilitating - Blue coloration - “Blue Fugates” of Kentucky Confidential, for Internal Use Only 2009 Masimo Corporation What Causes Acquired Methemoglobinemia? Commonly prescribed drugs induce methemoglobinemia Ingestion and inhalation of nitrate/ nitrite-rich substances (e.g. foods, add

47、itives, curatives, chemicals from fires, inhaled Nitric Oxide) can produce significantly elevated levels of Methemoglobinemia Traditional diagnostic marker for MetHb: an unnatural “chocolate brown color of arterial blood sample (as opposed to a bright red color) MetHb O2Hb Confidential, for Internal

48、 Use Only 2009 Masimo Corporation Case Study: Acquired MetHb Misdiagnosis 22 y/o Female Patient presents to Emergency Department with ambiguous symptoms and is diagnosed as an ectopic pregnancy Surgeon notes “chocolate-brown” colored blood and patient is then diagnosed with toxin-induced methemoglob

49、inemia ABG sample was obtained: MetHb was 40.5% by CO-Oximeter. Methylene blue IV given to clear methemoglobin Upon awakening patient revealed that she had eaten a large amount of BBQ One hour later 2 other patients presented to the ED with less severe but similar symptoms derived from the same even

50、t Investigation revealed that the meat had been cured in saltpeter (nitrate-laden causative agent) Yang JJ, et al. Acta Anaesth Scand 2005 Apr;49(4):586-588. Confidential, for Internal Use Only 2009 Masimo Corporation Methemoglobinemia: Causes and Clinical Locations OR PICU CTICU NICU General Care A

51、reas Emergency Department Cath Lab Bronchoscopy Endoscopy Outpatient Clinics (rheumatology, HIV, dermatology, oncology) Johns Hopkins Study Ash-Bernal R, Wise R, Wright SM. Medicine 2004;83:265273 Benzocaine 83(5):265-273. Confidential, for Internal Use Only 2009 Masimo Corporation High Risk Groups

52、Patients at High Risk for Negative Outcomes Children Elderly Adults with cardiac disease Patients with decreased O2 carrying capacity (Anemia) Patients with chronic respiratory insufficiency Pregnant women, with emphasis on fetal damage and death Cerebral palsy Limb and cranial deformities Mental di

53、sabilities Confidential, for Internal Use Only 2009 Masimo Corporation Methylene Blue: Caution Pulse oximeter values will be unreliable during methylene blue administration. It causes a temporary false increased estimation of desaturated hemoglobin with each infusion. Methylene blue treatment can re

54、sult in rebound MetHb to dangerous levels, requiring continuous monitoring. Confidential, for Internal Use Only 2009 Masimo Corporation 0 2 4 6 8 10 12 14 SpMet (%) 02468101214 HbMet (%) FDA Validations Masimo Rainbow SET Compared to Reference Methodology Noninvasive measurement provides clinically

55、equivalent results for MetHb without the need for invasive blood draw Excellent Precision and Accuracy Confidential, for Internal Use Only 2009 Masimo Corporation Traditional Lab Hb: Invasive, Delayed, Intermittent Confidential, for Internal Use Only 2009 Masimo Corporation Rainbow SET SpHb: Noninva

56、sive, Immediate, Continuous Potential Benefits Earlier and better clinical decisions Improved patient safety Decreased costs Confidential, for Internal Use Only 2009 Masimo Corporation Hemoglobin Measurement Options Comparison Device Characteristics Substrate for Analysis Sample Needle Stick Hazard

57、Biohazard Waste Disposal Special Training/Quality Control Calibration Patient Apprehension CO-Oximeter, Hematology Analyzer, Point-of-Care Device Pulse CO-OximeterTM Invasive, Delayed, Intermittent Noninvasive, Immediate, Continuous Blood Pulsating Blood CuvetteFinger YesNo YesNo YesNo Yes No Modera

58、te to HighLow Confidential, for Internal Use Only 2009 Masimo Corporation SpHb Confidential, for Internal Use Only 2009 Masimo Corporation Data collected at three sites Loma Linda Medical Center (Loma Linda, CA) Mayo Clinic (Jacksonville, FL) Masimo Corporation (Irvine, CA) Hb measurement Noninvasiv

59、e: Masimo Rainbow SET platform (SpHb) Invasive: Radiometer ABL-820 CO-Oximeter (tHb) 492 data pairs collected from 59 total subjects 35 (59%) healthy adults 16 (27%) hemodilution subjects 8 (14%) from surgical subjects Collected tHb values had a range of 6 to 18 g/dL 220 (45%) 12 g/dL 145 (29%) 11 g

60、/dL 74 (15%) 10 g/dL Noninvasive Hemoglobin: Study Methods and Results for FDA Submission Confidential, for Internal Use Only 2009 Masimo Corporation Noninvasive Hemoglobin: Study Results for FDA Submission CorrelationBiasPrecision (1 SD) 0.900.08 g/dL0.95g/dL N=492 Confidential, for Internal Use On