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hepcon hms with body surface area calculation
Hemotech
Summary: The Hepcon HMS with Body Surface Area Calculation is a device used for heparin dosing and monitoring during procedures like cardiopulmonary bypass. It is primarily used by cardiovascular surgeons and anesthesiologists in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K911240 ↗
Decision Date
July 17, 1991
Product Code
JOX
Device Class
Class 2
Evidence
0 studies
The Hepcon HMS with Body Surface Area Calculation was cleared by the FDA via the 510k pathway on July 17, 1991. Manufactured by Hemotech, it is classified as a Class 2 device under product code JOX.
What It Is
The Hepcon HMS is a heparin management system that calculates the appropriate dose of heparin based on body surface area, ensuring effective anticoagulation during surgical procedures. It provides real-time monitoring and adjustment of heparin levels, which is critical in procedures requiring cardiopulmonary bypass. This system helps in minimizing the risk of bleeding and thrombotic complications.
Clinical Applications
The device is commonly used in cardiac surgeries, especially those involving cardiopulmonary bypass, where precise heparin management is crucial. It is typically utilized in hospital settings by cardiovascular surgeons and anesthesiologists. The system is beneficial for adult and pediatric patients undergoing complex cardiac procedures, ensuring safe and effective anticoagulation.
Indications for Use
The Hepcon HMS is indicated for use in managing heparin dosing during surgeries that require anticoagulation, such as open-heart surgeries. It is designed for patients who need precise heparin management to prevent excessive bleeding or clot formation.
Practical Considerations
The device requires calibration and setup before use, and it is compatible with standard heparin products. Clinicians should be trained in its operation to ensure accurate dosing. The system's integration with other monitoring equipment can enhance its utility in the operating room.
Related Literature
The linked study compared heparin administration using the Hepcon HMS and another device, Rapidpoint Coag, in patients undergoing cardiopulmonary bypass. It found differences in heparin dosing and postoperative outcomes, such as blood loss and transfusion needs. However, the study was retrospective and limited by its design, which may affect the generalizability of the findings.
Frequently Asked Questions
What is the Hepcon HMS with BSA Calculation used for?
It is used for managing and monitoring heparin dosing during surgeries requiring anticoagulation, such as cardiopulmonary bypass.
What specialties typically use this device?
Cardiovascular surgeons and anesthesiologists primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for managing heparin dosing in surgical procedures that require anticoagulation, particularly in cardiac surgeries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.