Proven safety and reliability
- The heart-lung machine built upon more than 40 years of perfusion know-how and world leadership.
- Each module can work independently from one another: no central control, no central failure or breakdown of the whole HLM.
- Reliable, low maintenance pumps have no belts and gearbox.
- Panel displays can be exchanged during HLM function without compromising the procedure.
- Easy and immediate detection of critical situations.
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Monitoring, controls and software programs
- The S5 System is operated by a PC-independent software using microcontrollers in conjunction with a serial CAN bus.
- The system incorporates monitoring, controls and intelligent operable software programs.
Fully flexible and configurable modular concept
- S5 can be configured according to the clinical need by adapting pump numbers and modules.
- Different console for 3, 4 or 5 roller pumps.
- Additional mast mounted roller pumps and centrifugal pump are available.
- The modular system panel design can be mounted to the left, right or center of the S5.
Functional and easy to use
- The S5 affords easy interaction and visibility of the system during cardiopulmonary bypass procedures.
- Designed with panel touch screens that allow configuration of the system.
- Fast and easy panel navigation enabled by touch screen display.
- User interface with 30 languages to support users in multiple countries.
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S5 PRO is the LivaNova Perfusion Solution concept that combines LivaNova products and services to support your perfusion practice
Summary of Safety & Performance Information for S5 HLM
1. INDICATIONS FOR USE / INTENDED PURPOSE
EU:Devices are intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.
US: The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Canada: In accordance with the applicable regulations, the Stöckert S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation.
2. CONTRAINDICATIONS
There are no known contraindications for the Stöckert S5 System.
3. WARNINGS
The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product.
4. PRECAUTIONS
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product.
The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website (www.sorinmanuals.com) to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events. The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product. Not approved in all geographies, consult your labeling.
Manufactured by:
LivaNova Deutschland GmbH
Lindberghstrasse 25
D-80939 Munich, Germany
Distributed in the USA by:
LivaNova USA, Inc.
14401 W. 65th Way
Arvada, CO 80004
EssenzTM
Built on LivaNova’s 50-year legacy of safety and reliability, Essenz supports the Perfusionist in doing what is best for each patient, and allows the entire heart team to continuously improve their clinical practice.
Please Note: Essenz information available only in selected geographies. This product is not available for sale. It is currently in development and is intended to be approved by relevant authorities.Related Products
