Summary of Safety & Performance Information for INSPIRE
1. INDICATIONS FOR USE / INTENDED PURPOSE
Inspire Oxygenator (Models: Inspire 6, Inspire 7, Inspire 8)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices used to replace the patient respiratory function during cardiopulmonary bypass procedures. They are used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood, and to cool or warm the blood during cardiopulmonary bypass procedures.
The devices must be to be used up to 6 hours or less
Inspire Oxygenator with integrated arterial filter (Models: Inspire 6F, Inspire 7F, Inspire 8F)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices used to replace the patient respiratory function during cardiopulmonary bypass procedures. They are used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood, and to cool or warm the blood during cardiopulmonary bypass procedures.
The integrated arterial filter provides filtration against air and solid emboli
The devices must be to be used up to 6 hours or less
Inspire Cardiotomy/venous reservoir (Models HVR, and HVR dual)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices allowing oxygenators to exploit gas exchange for the replacement of patient respiratory function during cardiopulmonary bypass procedures., providing dynamic patient’s venous blood collection. They also defoam and filter venous blood and suction blood through a filtering system made of antifoam agent and filter screen. Can be used post-operatively for chest drainage.
The devices must be to be used up to 6 hours or less
2. CONTRAINDICATIONS
No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.
3. WARNINGS
The device must be used in accordance with the instructions for use provided in 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
5. ADVERSE EVENTS
The following table summarizes harms potentially arising during the use of the medical device, including those related to the intrinsic risks of extracorporeal circulation:. Systemic Inflammatory Response Syndrome (SIRS), Hypoperfusion / Hypoxia, Embolism / Hypovolemia / Sepsis / Infection / Fever / Shock/ Allergic reactions / Cyto-toxic reactions / Genetic mutation / Cancer / Haemolysis / Organ damage / Acid base imbalance (only for oxygenator) / Cross contamination / User contamination / Environment contamination / Thrombosis / Impaired hemostasis / Blood activation / Bleeding / User skin tears and Pneumothorax (only for cardiotomy/venous reservoir)
6. PERFORMANCE INFORMATION
The devices are designed to come into contact with patient blood and are single use, non-toxic, non-pyrogenic, supplied sterile in individual packaging. Sterilised by ethylene oxide. The level of ethylene oxide residuals in the device is within the limits established by national regulations in the country of use.
The device are coated with Phisio (PC phosphorylcholine) coating. Devices coated with Phisio are used when a coated blood path is desired
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 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.
Manufactured by:
Sorin Group Italia Srl
A wholly-owned subsidiary of LivaNova PLC
Via Statale 12 Nord, 86
41037 Mirandola (MO) Italy
Теl: +39 0535 29811 - Fax: +39 0535 25229
info.cardiacsurgery@livanova.com