Cardiopulmonary

B-Capta

B-Capta
Available in:
USA
Outside USA

B-Capta

The new ready-to-go in-line blood-gas monitoring system, integrated into the S5.

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Picture of B-Capta Heartlung Machine

The new ready-to-go in-line blood-gas monitoring system, integrated into the S5.

 

B-Capta® is designed to easily and accurately monitor Arterial and Venous Blood Gas Parameters even in long and complex Pediatric and Adult cardiopulmonary bypass procedures.

B-Capta® provides an in-line continuous monitoring of the patient’s blood parameters and allows the operator to quickly react to parameters’ changes.

B-Capta® supports the implementation of the Goal-Directed Perfusion (GDP) therapy in Connect, that enables perfusionists to maintain accurate perfusion procedure records.1,2

IM-7300264-CP A

Features

logo for sensors

B-Capta Sensors  

Proven safe and reliable
B-Capta is based on an accurate and reliable optical-based technology, improved to guarantee the highest level of accuracy and reliability when measuring patient blood gas parameters,even in long and complex cardiopulmonary bypass procedures.

Accurate and continuous measurements
B-Capta allows accurate monitoring of pO2 and temperature in the Arterial line and saturation, HCT /Hb and temperature in the Venous line. It does not provide calculated parameters, but only measured values to guarantee accurate monitoring.

Pediatric and adult procedures with the same sensor
The B-Capta Arterial and Venous sensors fit all disposable cuvette sizes, allowing the perfusionist to use the same sensor for both pediatric and adult procedures.

They are easy to couple with the relevant disposable cuvettes as they are identified by different color-coded labels.

logo for sensors

Sensor Module  

Ready-to-go
B-Capta does not require any calibration procedure to set the device measurements, allowing
the perfusionist to save time during device set up, especially in emergency cases.

Easy parameters alignment with ABL measurement
B-Capta's innovative technology embeds a compensation algorithm to easily adjust the blood
gas parameters according to those of the Hospital Laboratory Blood Gas Analyzer (ABL) to
ensure trending accuracy during the entire procedure.

S5 Display  

Easy and intuitive user interface
The Venous and Arterial parameters monitored by B-Capta are shown in the S5 system panel.
The B-Capta user interface is intuitive and easy to use: easy parameter configuration and
menu navigation, clearly displayed parameters and accessible system panel layout.

S5 user-experience
The B-Capta display is integrated in the S5 heart-lung machine allowing the perfusionist to:5

  • Do without additional external monitors and holders that may obstruct the perfusionist's view during the procedure
  • Have all patient and procedure parameters in the same location, reducing the levels of stress felt by the perfusionist during the procedure.

Visual and audible warnings
B-Capta has an integrated warning system based on thresholds selected by the user, providing
visual and audible indicators when parameters fall outside said thresholds.

Connect  

Accurate perfusion records
Throughout the entire procedure, the B-Capta blood gas values are automatically transferred to Connect, LivaNova’s data management system, enabling the perfusionist to maintain accurate perfusion procedure records.

Support the implementation of Goal-Directed Perfusion (GDP) therapy in Connect1,2
The B-Capta Arterial and Venous parameters can be used to feed the GDP formulas in Connect, as they are continuously transferred to Connect during the procedure through the S5 serial interface.1,2

Cuvettes  

Disposable solution tailored to customers’ needs
The Venous and Arterial disposable cuvettes are available as sterile stand-alone disposables or included in the Perfusion Tubing Systems, both pre-connected and not.

The Venous cuvettes are available in three sizes: 1/2", 1/4", 3/8"

The Arterial cuvettes are available in two sizes: 3/8", 1/4"

Safety Information

Summary of Safety & Performance Information for B-CAPTA 

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. 

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.

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.

Manufactured by:
Sorin Group Italia Srl
A wholly-owned subsidiary of LivaNova PLC
Via Statale 12 Nord, 86
41037 Mirandola (MO) Italy
Tel. +39 0535 29811 - Fax +39 0535 25229
info.cardiacsurgery@livanova.com

Manufactured by:
LivaNova Deutschland GmbH
Lindberghstra├če 25, D-80939 M├╝nchen Germany
T: +49(0)89.32301.0, F: +49(0)89.32301.555

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Bibliography

  1. Ranucci M. et al., Carbon dioxide production during cardiopulmonary bypass: pathophysiology, measure and clinical relevance - Perfusion 2016.
  2. Ranucci M. 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 Extracorporeal Technology, 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.

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