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INSPIRETM 6 PH.I.S.I.O

INSPIRETM 6 PH.I.S.I.O
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INSPIRETM 6 PH.I.S.I.O

Product catalog summary
Overview of INSPIRETM 6 PH.I.S.I.O.
The INSPIRETM 6 PH.I.S.I.O. is engineered to enhance perfusion during cardiopulmonary bypass (CPB) by minimizing hemodilution, reducing blood contact surface area, and controlling gaseous microemboli (GME). It extends the maximum blood flow rate to 6 LPM, making it suitable for a broader patient demographic.

Specifications and Features
  • Flow Rate: Supports up to 6 LPM, exceeding the previous limit of 5 LPM for small adult devices.
  • Design: Incorporates a low prime oxygenator with optimal gas transfer rates, ideal for minimized extracorporeal systems.
  • Biocompatibility: Enhanced with PH.I.S.I.O PC coating to reduce platelet activation and cell adhesion.
  • Arterial Filter: Integrated design enhances safety by reducing connections and improving GME handling.

Performance and Efficiency
  • Hemodilution: Minimizes hemodilution impact through low priming volumes and dynamic operating volume (DOV) management.
  • GME Handling: Advanced design in oxygenator modules and reservoirs effectively controls GME, reducing potential neurological damage.
  • Heat Exchanger: Newly designed polyurethane heat exchanger ensures efficient heat transfer up to 6 LPM.

Clinical and Operational Benefits
  • Patient Outcomes: Aims to improve outcomes and reduce care costs by minimizing CPB impact.
  • Flexibility: Compact, easy to set up, and offers operational flexibility with a single bracket fitting all models.
  • Inventory Management: HeartLink Card and GDP MonitorTM aid in implementing Goal Directed Perfusion principles, potentially reducing ICU and hospital stays.

Conclusion
The INSPIRETM 6 PH.I.S.I.O. represents a significant advancement in perfusion technology, offering enhanced performance, safety, and biocompatibility for a wider range of cardiac surgery patients.

Overview of LivaNova HeartlinkTM System
The document also covers the LivaNova HeartlinkTM System, which integrates perfusion data, patient parameters, and product information to enhance case management and Goal Directed Perfusion principles. It emphasizes monitoring oxygen and carbon dioxide exchange, particularly DO2 and DO2/VCO2, to reduce acute kidney injury and lactate levels during CPB.

Key Components
  • HeartLink Card and System: Facilitates automatic data loading related to INSPIRE oxygenator systems, reducing manual operations and potential human errors, ensuring data integrity and process standardization.
  • INSPIRE Oxygenator Family: Complements the LivaNova HeartlinkTM System with S5/C5 Heart-Lung machines, Connect Perfusion Charting System, and XTRA® autotransfusion machine.

Performance and Specifications
  • Oxygenator System: Features a biocompatible coating and a maximum blood flow rate of 6 l/min, with a static priming volume and a polyurethane heat exchanger section.
  • Filtration Sections: Venous and cardiotomy reservoir sections use polyester filtering media.
  • Performance Charts: Include data on maximum flow rates, bubble counts, CO2 transfer, O2 transfer, and heat exchange efficiency under specific test conditions.

Technical Specifications
  • Details on various INSPIRE models, including PHISIO OXY modules with integrated arterial filters and dual chamber hard shell venous reservoirs.
  • Specifications for oxygenator system DOV, reservoir capacities, and filtration media types.

Manufacturing and Compliance
The document is produced by Sorin Group Italia Srl, a subsidiary of LivaNova Plc, and complies with EN ISO 13485:2012/AC 2012 standards.
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Catalog excerpts

INSPIRETM 6 PH.I.S.I.O-1

Health innovation that matters Optimized perfusion

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INSPIRETM 6 PH.I.S.I.O-2

Optimized perfusion The goal of optimized perfusion is to minimize the impact of Cardiopulmonary Bypass (CPB) on patient outcomes by focusing on reducing hemodilution and blood contact surface area, minimizing gaseous micro emboli (GME) and improving biocompatibility, while providing high performance. Until Inspire, small adult devices have been considered the benchmark for optimized perfusion, but are limited in flow to 5 LPM. By extending the maximum blood flow rate from 5 to 6 LPM, the new INSPIRE 6 LPM optimized adult oxygenator systems extend the benefits of small adult devices to a wider...

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INSPIRETM 6 PH.I.S.I.O-3

INSPIRE 6 LPM oxygenator systems are the only optimized adult oxygenator systems with a low blood contact surface area which can minimize impact on hemodilution and effectively control GME, while offering full performance up to 6 LPM maximum blood flow, therefore covering a wide patient flow requirements. INSPIRE 6 LPM oxygenator systems offer the ideal solution for optimized perfusion and have been conceived to help clinicians minimize the impact of CPB on a wide patient population, aiming to improve outcome and reduce cost of care. They are available with and without integrated arterial filter,...

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INSPIRETM 6 PH.I.S.I.O-4

FULL PERFORMANCE UP TO 6 LPM THE ONLY OXYGENATOR WITH 6 LPM MAXIMUM RATED BLOOD FLOW OUTSTANDING LOW PRIME VOLUME AND BLOOD CONTACT SURFACE AREA • Only 1,4 m2 membrane surface area and 0,4 m2 for the INSPIRE 6 LPM oxygenators can offer the benefits of less hemodilution and low blood contact surface area heat exchanger. • More than 30% reduction in foreign surfaced area vs. full found in small adult oxygenators, but go beyond their 5 adult 2.5 m2 competitive devices. • The remarkably efficient INSPIRE oxygenator longitudinal • Only 184 ml oxygenator priming volume for the standard flow design...

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INSPIRETM 6 PH.I.S.I.O-5

MINIMIZED IMPACT ON HEMODILUTION Minimizing hemodilution contributes to decreased blood transfusions and improved clinical outcomes during and after cardiopulmonary bypass (CPB). Until now, the impact on hemodilution was associated with oxygenator module static priming volume. With INSPIRE we are introducing a new concept: the oxygenator system dynamic operating volume (DOV), which allows to evaluate the overall hemodilution impact of an oxygenator system. The oxygenator system DOV is defined as the sum of four elements: the oxygenator module priming volume, the reservoir minimum operating level,...

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INSPIRETM 6 PH.I.S.I.O-6

SUPERIOR GME HANDLING* Gaseous microemboli are commonly indicated as potential sources of neurological damage after CPB. Dedicated design solutions within the INSPIRE HVR, HVR DUAL and in the INSPIRE oxygenator modules provide effective gaseous microemboli (GME) control, by approaching GME handling at a system level. DESIGNED FOR EFFECTIVE AIR MANAGEMENT It has been widely demonstrated by recent studies** that the reservoir plays a key role in controlling GME: “The venous reservoir significantly influences embolic load delivered to the oxygenator ( p < .001). [...] Venous reservoir design influenced...

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INSPIRETM 6 PH.I.S.I.O-7

DUAL CHAMBER RESERVOIR FOR ENHANCED BIOCOMPATIBILITY INSPIRE DUAL systems provide clinicians new options for activated suction management allowing a dedicated solution for advanced perfusion. The combination of INSPIRE DUAL systems, PHISIO PC coating and LivaNova XTRA autotransfusion system, offers clinicians a comprehensive solution to enhanced biocompatibility. ACTIVATED SUCTION SEPARATION “Aspirated blood contaminated by tissue contact is the “Combination of coating and avoidance of shed blood most important activator of the coagulation system and recirculation maintained physiological coagulation...

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INSPIRETM 6 PH.I.S.I.O-8

PH.I.S.I.O. COATING PH.I.S.I.O PC coating has proven to be extremely effective in All INSPIRE oxygenators are PH.I.S.I.O PC coated and, reducing platelet activation and cell adhesion to foreign surface. PH.I.S.I.O PC coating is also applied to all INSPIRE HVR and HVR DUAL blood contact surfaces: HVR bucket and venous “The interaction of blood with foreign artificial surfaces return collector, frame of venous return filter. both venous during cardiopulmonary bypass (CPB) has been recognized and cardiotomy filtering nets. as a major stimulus in evoking a systemic inflammatory and metabolic response....

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INSPIRETM 6 PH.I.S.I.O-9

LIVANOVA HEARTLINK SYSTEM TM THE FIRST CARDIOPULMONARY BYPASS SYSTEM LivaNova HeartlinkTM is the first perfusion system to provide a unique link between perfusion data, patient parameters and product information to assist with case management and Goal Directed Perfusion principles. INSPIRE TM oxygenator family is the latest addition that, together with S5/C5 Heart-Lung machines, Connect Perfusion Charting System and XTRA® autotransfusion machine, completes the LivaNova HeartlinkTM System.The LivaNova HeartlinkTM card, available only with LivaNova INSPIRE, is the key to make system TS features...

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INSPIRETM 6 PH.I.S.I.O-10

DYNAMIC OPERATING VOLUME (DOV) PERFORMANCE CHART Venous filter 23 hold-up volume ml Overall impact on Hemodilution of the Oxygenator System at maximum blood flow Minimum 150 operating level ml * TEST CONDITIONS (Bovine blood - Hb 12±0.2 gr/dl - B.E. 0±2mEq/l - Venous pCO2 45±5 mmHg - O2 Venous Sat. 65±5% - Blood Temp. 37±1 °C - QG /QB =1 - FiO2 100% - Qw=11,5±0,2 l/min) Venous collector 45 priming volume ml INSPIRE 6 M Total O2 Transfer (ml/min) Oxy module 184 priming volume ml Blood flow rate (l/min) OXYGENATOR SYSTEM DOV (at maximum blood flow) INSPIRE 6 v. Small Adult Oxygenator Systems* INSPIRE...

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INSPIRETM 6 PH.I.S.I.O-11

DYNAMIC OPERATING VOLUME (DOV) PERFORMANCE CHART Venous filter 23 hold-up volume ml Overall impact on Hemodilution of the Oxygenator System at maximum blood flow Minimum 150 operating level ml * TEST CONDITIONS (Bovine blood - Hb 12±0.2 gr/dl - B.E. 0±2mEq/l - Venous pCO2 45±5 mmHg - O2 Venous Sat. 65±5% - Blood Temp. 37±1 °C - QG /QB =1 - FiO2 100% - Qw=11,5±0,2 l/min) Venous collector 45 priming volume ml Oxy module 284 priming volume ml INSPIRE 6F M Total O2 Transfer (ml/min) Blood flow rate (l/min) OXYGENATOR SYSTEM DOV (at maximum blood flow) INSPIRE 6F v. Small Adult Oxygenator Systems*...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.