Adult All Integrated Mini Bypass System

Adult All Integrated Mini Bypass System

Clinical Flexibility without Sacrificing Patient Safety Imagine a new, innovative, completely closed system that includes a venous bubble trap, centrifugal pump, heat exchanger/oxygenator and arterial filter, all integrated into one single device. Synergy is based on a compact, dedicated HLM platform complete with all standard safety features and includes the use of the BRAT ATS system for suction blood sequestration. S5 minibypass HLM configuration SCP + provides a simple, ergonomic user interface for managing SYNERGY Mast mounted S5 double head roller pumps ideal for shortening APC and cardioplegia lines APC - maximizing entrained air management 3 position S5 optimal for all mini bypass cases ERC - maximun patient safety, unique to Sorin Group Extension arm permits positioning of SYNERGY as close as possible to patient

SCPC+SCP Centrifugal Pump System The Synergy was developed around the Revolution Centrifugal Pump, which offers many key safety features including: Excellent air handling capability Low prime volume Low heat generation Low index of hemolysis Estremely efficient design Low blood transit time No areas of stagnating flow BRAT2 Autologous Blood Recovery System Performance, Speed, Versatility, and Quality Processing Dedicated processing keys to start processing quickly and easily Built-in reservoir holder eliminates the need for additional holder Flat, clear lid with safety lock provides visibility of the bowl and a flat writing surface Smaller profile fits well in any size operating room Storage area for additional supplies Three position wheel locking mechanism maximizes mobility Easy to load disposables snap correctly into place without hassle Automatic re-pack feature removes excessive plasma free hemoglobin and ensures proper bowl filling Patented Baylor Bowl provides a high hematocrit and fast processing

Purge line used with roller pump + APC Bubble sensor for APC ERC Bubble sensor for ERC Electric Remote Clamp (ERC) Offers the same level of safety as a fluid level sensor of a conventional venous reservoir Can be manually operated from the SCP Centrifugal Pump Control Console Closes automatically when air is detected coming from venous bubble trap Prevents retrograde flow and closes when arterial flow goes to LPM Air Purge Control (APC) Dedicated module for the S5 control panel Used in conjunction with a bubble sensor on the venous inlet line as shown above to manage venous air Uses a dedicated roller pump on the SIII and S5 Purged volume is sent to a storage reservoir or cardiotomy in the circuit to prevent loss of autologous blood

Improved Patient Outcomes Optimised Bypass - Combining the clinical benefits of phosphorylcholine and suction blood separation with low prime, significant reduction of the blood-air interface, and reduced foreign surface area in contact with the patient circulating volume. The concept of optimized or Mini Bypass combines all the known benefits into one total systemic approach to improve patient outcomes on pump. Several clinical studies have demonstrated the efficacy of the mini bypass concept in terms of reduced Hemodilution and subsequent reduction in blood products use. Blood Hemoglobin, On Pump 13 12 11 1 9 8 7 6 5 Pre bypass After cardioplegia Crossclamp off cecc Frequency of transfusions Units of blood transfused Units FFP cecc p,27 ±,45,43 ±,5.5,53 ±,9 1,3 ± 1,93 <.5 3 <.1 Cumulative Post Operative Bleeding (during ICU stay) 1, 8, 6, 4, 2,, cecc Dr M Perthel, Bad Bevensen Blood Product Usage in Routine CABG Compared to Conventional Bypass Presented at the Canadian Cardiothoracic Meeting, Montreal 25 Creatine Kinase 6 * p<.5 5 * p<.5 Further studies have demonstrated the clinical benefits of higher on pump hematocrit in terms of quality of perfusion, as well as the benefits in terms of reduced platelet activation and systemic inflammatory response. 4 3 (U/L) 2 1 ICU ICU 2h ICU 8H ICU POD 29 261 299 45 Control 211 256 453 53 Dr MJM Hybregts et al, Free University Hospital Amsterdam, The Netherlands Quality of Perfusion in Mini Bypass as Compared to Conventional Bypass Presented at FECECT, Orosei, Sardinia June 25 P-Selectin Plasma Level Prothrombin fragment formation 8 7 6 5 4 3 2 1 P=.3 P=.3 t t1 t2 t3 t t1 t2 t3 1,5 1,2,9,6,3 Prothrombin and P-Selectin plasma levels (mean ± SD) at various time points: prior the sternotomy (TO), at the end of CPB (T1), at 6 (T2) and 24 hours (T3) after CPB P<.3 P<.3 Standard CPB Dr A. Farneti and Dr M Glauber, Ospedale S. Pasquinucci, Massa Italy Reduction of coagulative response and monocyte-platelet interaction following the use of minimal extracorporeal circulation system in CABG patients Presented at EACTS 25, Barcelona Spain

SYNERGY: the evolution of CPB, emphasising clinical flexibility and biocompatibility without sacrificing patient safety Key Functional Characteristics, SYNERGY System Prime volume 68 ml Oxygenator Surface Area 2. m 2 SYNERGY Maximum Recommended Rated Flow 8 LPM Pressure Drop, Oxy/Filter Module 3 Oxygen Transfer 5 ΔP (mmhg) 25 2 15 1 5 ml / min 4 3 2 2 3 4 5 6 7 8 1 Testing was performed with bovine blood at standard AAMI conditions and at a barometric pressure of 76 + 1 mm Hg. Mean values are shown for comparison purposes only and may not represent clinical performance., 2, 4, 6, 8, Blood Flow Rate (l/min) CO 2 Transfer 6 Qg/Qb,5/1 Qg/Qb 1/1 Qg/Qb 2/1 Heat Exchange 1. 5.9.8 ml / min 4 3 2 1 Performance Factor.7.6.5.4.3.2.1, 2, 4, 6, 8, Blood Flow Rate (l/min). 1 2 3 4 5 6 7 8 Blood Flow Rate (LPM)

Venous Optiflow Cannulaa Specifically designed for active venous drainage The special-design injection-molded 13 cm tip with multiple holes grants an optimal venous drainage independent of the position of the heart Wire reinforced PVC tubing with depth markings and introducer Available size: 29 French Arterial Cannula 3 dimensional dispersion of the blood flow big opening outlet area Optiflow Characteristics avoids jet stream homogenous flow profile with low velocities reducing dislodgement of plaques and so the risk of atheroembolic complications with low pressure gradients and no increasing of the haemolysis smooth tip for easy insertion The OPTIFLOW is another dedicated product in our range, to improve the biocompatibility of the whole ECC system, our multifactorial approach. CSC-14 The CSC -14 Cardioplegia Heat Exchanger. With a priming volume of 3 ml, superior heat exchange characteristics and excellent blood flow path visibility, the CSC-14 provides the clinician with a means of managing myocardial protection in a safe and flexible way.

ORDER GUIDE SYNERGY SYSTEM DESCRIPTION CODE Standard Closed System 74622 Standard Open System (with Cardiotomy reservoir) 74632 Closed to open system conversion kit 84392 Synergy Holder 5131 Mini bypass Reservoir Bag Holder (for 74622) 5124 D716 Holder for D764 Cardiotomy reservoir (for 74632) 573 D712 Holder for Sampling Manifold 569 For more information regarding the S5 mini HLM, the Brat2 System, and order information, please contact your local representative. Please contact Sorin Group North America for the standard SYNERGY configuration in the US market. Please read all product instructions for use prior to clinical use of the system. according to MDD 93/42/ECC emended by Directive 27/47/EC manufactured by: Sorin Group Italia S.r.l. Via Statale 12 Nord, 86 4137 Mirandola Modena Italy Tel +39 535 29811 Fax +39 535 24312 www.sorin.com info.sorin-cp@sorin.com 933-42 9/9