B-Capta™ Blood-Gas Monitoring
The ready-to-go in-line blood-gas monitoring system
1. Ranucci M. et al., Carbon dioxide production during cardiopulmonary bypass: pathophysiology, measure and clinical relevance -Perfusion 2016.
2. RanucciM. et al., Oxygen Delivery During Cardiopulmonary Bypass and Acute Renal Failure After Coronary Operations -ATS 2005.
3. Ottens J. et al., Improving Cardiopulmonary Bypass: Does Continuous Blood Gas Monitoring Have a Role to Play? -JECT. 2010;42:191–198.
4. Trowbridge CC et al., The Effects of Continuous Blood Gas Monitoring During Cardiopulmonary Bypass: A Prospective, Randomized Study-Part II -The Journal of ExtracorporealTechnology, 2000.
5. Merkle F. at al., Evaluation of attention, perception and stress levels of clinical cardiovascular perfusionists during cardiac operations: a pilot study-Perfusion 2019
1. INDICATIONS FOR USE / INTENDED PURPOSE
The B-Capta is intended to be used for in-line continuous monitoring of patient’s blood parameters during procedures requiring extracorporeal circulation. Provided in-line measured parameters are:
in the Venous line:
- Haematocrit / Haemoglobin (Hct/Hb)
- Venous blood oxygen saturation (sO2)
- Venous blood temperature (venT) in the Arterial line:
- Arterial blood oxygen partial pressure (pO2)
- Arterial blood temperature (artT)
The cuvettes are intended for use in adult and pediatric surgical procedures requiring cardiopulmonary to support monitoring of above mentioned parameters bypass. The devices are intended to be used for 6 hours or less. The B-Capta venous and arterial cuvettes must only be used with the B-Capta equipment.
No contraindications are known if thedevice 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.
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
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 providedby 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.
LivaNova Deutschland GmbH
D-80939 Munich, Germany