PulsioFlex Patient focused flexibility

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1 PulsioFlex Patient focused flexibility Modular platform with intelligent visualisation for advanced patient Minimally invasive perioperative cardiac output trend with ProAQT Enables calibrated cardiac output with PiCCO -Module Continuous central venous oxygen saturation with Non-invasive liver function with LiMON

2 PulsioFlex - Modular Platform with intelligent visualisation for advanced patient PiCCO -Technology The PiCCO -Module expands your PulsioFlex monitor to include the PiCCO -Technology Enhances the accuracy and precision of haemodynamic by the innovative combination of arterial pulse contour analysis calibrated via transpulmonary thermodilution The precise PiCCO parameters allow physicians to perform patient-individualised therapy with optimal use of inotropes and vasopressors PiCCO enables the measurement of extravascular lung water for pulmonary oedema assessment Clinically proven and widely accepted minimally-invasive alternative to the pulmonary artery catheter ProAQT -Technology The ProAQT -Technology is based on the PiCCO algorithm and is fully integrated into the PulsioFlex Monitor Beat to beat cardiac trend output for optimal perioperative haemodynamic management Works with standard arterial catheters for easy setup Reliable and validated interpretation of the patient s haemodynamic status to recognise patient instability early Enables detection of dynamic fluid responsiveness Multicenter study showing reduction in complications ProAQT supports manual calibration using external reference cardiac output values (e.g. echocardiography -Technology The -Module enables the continuous of the central venous oxygen saturation (ScvO 2 Based on fibreoptic measurement via a 2 french probe Allows tracking of early goal directed therapy effects to improve outcome ScvO 2 is highly sensitive to tissue hypoxia and enables early indication of perfusion deficit LiMON -Technology The LiMON -Module offers non-invasive global liver function by modified pulse oximetry LiMON measures the plasma disappearance rate of the diagnostic drug Indocyanine Green (PDR ICG Supports the physician to evaluate the perioperative risk of liver resection and helps to predict outcome of ICU patients Significant better specifity and sensitivity than standard liver function tests PiCCO ProAQT LiMON Flow Cardiac Index (CI, Stroke Volume Index (SVI PC Cardiac Index (CI Trend, Stroke Volume Index (SVI Oximetry Oxygen saturation Central Venous Oxygen Saturation (ScvO 2 Arterial oxygen saturation (SpO 2 Pulse contour analysis (continuous Contractility Organ function Afterload Volume responsiveness Left heart contractility (dpmx Cardiac Power Index (CPI Systemic Vascular Resistance Index (SVRI Stroke Volume Variation (SVV, Pulse Pressure Variation (PPV Left heart contractility (dpmx Cardiac Power Index (CPI Systemic Vascular Resistance Index (SVRI Stroke Volume Variation (SVV, Pulse Pressure Variation (PPV Thermodilution (discontinuous Flow Preload Contractility Organ function Cardiac Index (tdci Global End-Diastolic Volume Index (GEDI Cardiac Function Index (CFI, Global Ejection Fraction (GEF Extra Vascular Lung Water Index (ELWI, Pulmonary Vascular Permeability Index (PVPI ICG elimination Liver function Plasma Disappearance Rate of Indocyanine Green (PDR ICG, ICG Retention Rate after 15 min (R15

3 PiCCO -Technology Benefits of transpulmonary thermodilution? THERAPY Is the patient fluid responsive? Is the patient developing lung oedema? GEDI - Global Enddiastolic Volume Index The GEDI is a reliable and validated clinical parameter of preload (1 GEDI together with ELWI and stroke volume variation or pulse pressure variation measured by the PiCCO - Technology is a valuable solution for your patient s fluid management (2 GEDI based protocol is able to reduce length of ICU stay (3 ELWI - Extravascular Lung Water Index ELWI provides easy assessment of pulmonary oedema (4 Serves as a warning parameter for volume overload (5 Allows reduction in the frequency of thoracic X-rays for lung oedema quantification (6 What is the current cardiovascular situation? What is the cardiac preload and afterload? The PiCCO -Technology helps you to answer these questions. Optimized therapy in in cardiac surgery patients Complications reduced by 36 % (3 Length of ICU stay reduced by 32 % (3 ProAQT -Technology Benefits of continuous CO-trend The ProAQT -Technology is part of the PulsioFlex platform. Based on the results of 20 years research on pulse contour analysis ProAQT provides a reliable and validated interpretation of the patient s haemodynamic status. GDT - Goal Directed Therapy ProAQT enables goal directed therapy which helps save time and money as shown by Salzwedel et al.: (9 Supporting the optimisation of fluid resuscitation Decreasing postoperative complications Reducing infections Improve Patient Outcome Delivering haemodynamic information to physicians enabling the application of early goal-directed therapy Patient individualised treatment Early recognition of patient instability (9 Despite high standards in surgical and anaesthetic care, the perioperative mortality rate is still higher than expected (8 Pearse R.M. et al., Lancet Internal start value determiantion: Start value is determined based on the patient characteristics and details of the arterial pressure curve Continuous CI measurement Derived from analysis of the arterial pressure curve 2. Optional input of an external start value: A measured CI value form an external source (e.g. echocardiography Improve outcome in major abdominal surgery Complications reduced by 27.7 % (9 ELWI = 21 ml/kg BW ELWI = 11 ml/kg BW ELWI = 5 ml/kg BW Patients with complications reduced by 41.7 % (9 ProAQT is applicable for use in: Complex procedures with high risk of intra- and post-operative complications severe lung oedema moderate lung oedema no lung oedema Anticipated high blood loss (>20% and volume shifts during the procedure which can result in hypo- or hypervolaemia Pulmonary oedema is not easily detected by chest X-ray as demonstrated by the pictures above. ELWI is much more sensitive than chest X-ray. (7 Long surgery time (>120min

4 -Technology Benefits of continuous ScvO 2 LiMON -Technology Benefits of non-invasive liver function Start continuous ScvO 2 Is the patient at risk of an existing or developing liver dysfunction? Is there increased risk due to affected splanchnic perfusion/microcirculation? Is the remaining liver function enough to tolerate liver resection? If intermittent ScvO 2 < 70% If risk of hypoxia is suspected In high-risk-surgery patients O 2 Uptake O 2 Transport O 2 Extraction O 2 Utilisation Oxygen delivery - DO 2 I Oxygen Consumption - VO 2 I Central Venous Oxygen Saturation - ScvO 2 Is there graft dysfunction post liver transplantation? PDR ICG measurements via non-invasive LiMON finger sensor supports physicians efficiently in a broad field of applications to answer these questions and help to choose targeted therapy. Intensive Care ScvO 2 reflects the transportation and metabolism of oxygen. -Technology is a less invasive surrogate marker of mixed venous oxygen saturation. Inserted via a standard CVC the fibreoptic probe provides an indication as to how much oxygen is being extracted by the organs before the blood returns to the right side of the heart. Enables Early Intervention ScvO 2 in % continuous ScvO 2 BGA ScvO 2 LiMON immediately detects liver hypoperfusion Superior in predicting the survival probability (15 PDR ICG of less than 16%/min requires intervention (16 Optimised fluid therapy by LiMON in combination with PiCCO (17 Serves as an indicator of regional perfusion Liver Transplantation PDR-ICG (%/min without complications * p < Detect acute changes in systemic balance between oxygen delivery and consumption Traditional vital signs may be late indications of inadequate oxygen delivery to tissue Continuously and immediately tracks therapy effects Detect hypoxia earlier with continuous ScvO 2 Peri-operative evaluation of graft quality and function to reduce the probability of need for re-transplantation (18 Provides a reliable indicator of graft outcome early after surgery (19 Helps to identify complications prematurely ( with complications 30 time in hours 0 Reduce Complications & Mortality Liver Resection PDR ICG values below 13 %/min point to early serious complications, such as thrombosis, rejection or sepsis. (20 Low ScvO 2 is related to an increased risk of postoperative complications in high-risk surgery (10 Early goal directed therapy using ScvO 2 improves outcome (11 Patients with complications reduced by 80 % (12 28-day mortality reduced by 72 % (13 LiMON provides decisive parameters in pre-operative risk assessment A low PDR ICG excludes patients from major resection (21 Early identification of post-operative liver dysfunction Offers predictive power significantly higher than conventional markers (21 Sensitivity Decreases risk of infection by reducing frequency of BGA sampling Low ScvO 2 is associated with probability of lower survival (11 Control group Intervention group Cardiac Surgery Identify early life-threatening decreases in systemic oxygen delivery that would not be identified by intermittent sampling Reduce Cost Reduce length of hospital stay (12 Costs are similar to BGA measurements (14 Simplify the workflow of nursing staff Fit for ICU discharge reduced by 3 ( Postop. hospital stay reduced by 3 ( Pre-, peri- and early postoperative measurements of PDR ICG can serve as a predictor of prolonged ICU treatment. (22 Goal-directed strategies aimed at improving the PDR ICG can be considered to be undertaken in cardiac surgical patients at risk to improve outcome (22 Hepatology Valuable tool for the evaluation of prognosis in liver cirrhosis (15 Enables prediction of survival in intermediate advanced liver disease (15 ICG PDR PT Bilirubin Specificity ROC curves for PDR ICG, prothrombin (PT values and bilirubin values regarding the occurrence of post operative liver dysfunction. (21 Estimation of functional liver cell mass

5 Literature references 1. Michard F. et al., Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest 2003, 124(5: Adler C. et al., Fluid therapy and acute kidney injury in cardiogenic shock after cardiac arrest. Resuscitation 2013, 84(2: Goepfert M. S. et al., Individually Optimized Hemodynamic Therapy Reduces Complications and Length of Stay in the Intensive Care Unit: A Prospective, Randomized Controlled Trial. Anesthesiology 2013, 119(4: Khan S. et al., Transpulmonary dilution-derived extravascular lung water as a measure of lung edema. Curr Opin Crit Care 2007, 13(3: Kuhn C. et al., Extravascular lung water index: A new method to determine dry weight in chronic hemodialysis patients. Hemodial Int 2006, 10(1: Sakamoto Y. et al., Effectiveness of human atrial natriuretic Peptide supplementation in pulmonary edema patients using the pulse contour cardiac output system. Yonsei Med J 2010, 51(3: Sakka S. G. et al., Assessment of cardiac preload and extravascular lung water by single transpulmonary thermodilution. Intensive Care Med 2000, 26(2: Pearse R. M. et al., Mortality after surgery in Europe: a 7 day cohort study. Lancet 2012, 380(9847: Salzwedel C. et al., Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care 2013, 17(5: R Pearse R. M. et al., Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005, 9(6: R Kortgen A. et al., Implementation of an evidence-based standard operating procedure and outcome in septic shock. Crit Care Med 2006, 34(4: Smetkin A. A. et al., Single transpulmonary thermodilution and continuous of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand 2009, 53: Maquet Critical Care AB Röntgenvägen 2 SE Solna SWEDEN For local contact: Please visit our website De Oliveira C. F. et al., ACCM/PALS haemodynamic support guidelines for paediatric septic shock: an outcomes comparison with and without central venous oxygen saturation. Intensive Care Med 2008, 34(6: Bloos F. et al., Costs of intermittent measurement of central venous oxygen saturations by blood gas analysis. Intensive Care Med 2009, 35(7: Zipprich A. et al., Incorporating indocyanin green clearance into the Model for End Stage Liver Disease (MELD-ICG improves prognostic accuracy in intermediate to advanced cirrhosis. Gut 2010, 59(7: Sakka S. G. et al., Prognostic value of the indocyanine green plasma disappearance rate in critically ill patients. Chest 2002, 122(5: Sakka S. G. et al., Non-invasive liver function by indocyanine green plasma disappearance rate in critically ill patients. Int J Intensive Care 2002, 9(2: Mandel M. S. et al., Elimination of indocyanine green in the perioperative evaluation of donor liver function. Anesth Analg 2002, 95(5: Tsubono T. et al., Indocyanine green elimination test in orthotopic liver recipients. Hepatology 1996, 24(5: Levesque E. et al., Plasma disappearance rate of indocyanine green: a tool to evaluate early graft outcome after liver transplantation. Liver Transpl 2009, 15(10: Scheingraber S. et al., Indocyanine green disappearance rate is the most useful marker for liver resection. Hepatogastroenterology 2008, 55(85: Sander M. et al., Perioperative indocyanine green clearance is predictive for prolonged intensive care unit stay after coronary artery bypass grafting - an observational study. Crit Care 2009, 13(5: R149. PULSION Medical Systems SE Hans-Riedl-Straße Feldkirchen GERMANY Phone: +49 ( info@pulsion.com MPI4102EN_R PULSION Medical Systems SE

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