Hemochron Signature Elite: Overview
The Hemochron Signature Elite system sets the standard for point-of-care Hemostasis testing. It is a battery-operated whole blood microcoagulation system that can test fresh or citrated whole blood providing rapid, accurate results.
Point-of-Care Hemostasis Testing
The Hemochron Signature Elite system excels in point-of-care hemostasis testing, delivering rapid and standardized results for ACT, ACT-LR, PT, and APTT tests. This system provides clinicians with fast and reliable data directly at the patient’s side, eliminating delays associated with central lab testing. The Hemochron Signature Elite’s ease of use and comprehensive test menu make it an invaluable tool in acute care settings. It allows for quick assessment of a patient’s coagulation status, facilitating timely and informed treatment decisions to improve patient outcomes. Its portability and battery operation make it suitable for use in various locations.
Key Features and Benefits
The Hemochron Signature Elite offers a broad test menu, rapid results, and user-friendly operation. Its connectivity and compliance features enhance data management and regulatory adherence in point-of-care settings.
Rapid Whole Blood Testing
The Hemochron Signature Elite system standardizes rapid whole blood testing, delivering fast, accurate, and reproducible results at the point of care. It’s designed for acute care settings, such as Cardiovascular Operating Rooms and Cardiac Catheterization Labs, enabling prompt patient management decisions. This system utilizes a cuvette-based technology to measure fibrin formation, offering faster clot detection than other systems. The instrument can test fresh or citrated whole blood, with results available in minutes, facilitating timely intervention and improved patient outcomes. The system’s speed and accuracy make it a valuable tool for healthcare professionals.
Broadest Test Menu
The Hemochron Signature Elite system offers the broadest menu for rapid whole blood hemostasis testing and monitoring. This includes both high and low heparin ranges with ACT and ACT-LR tests, as well as PT and APTT for comprehensive assessment of coagulation pathways. It is ideally suited for various point-of-care settings, including Cardiovascular Operating Rooms, Cardiac Catheterization Labs, and Emergency Departments. The system’s comprehensive test menu allows healthcare providers to assess any dosage, any patient, and any operator, making it a versatile tool for managing anticoagulation therapy and hemostatic function in diverse clinical scenarios.
Accurate and Reproducible Results
The Hemochron Signature Elite system delivers rapid, accurate, and reproducible results, which are crucial for effective patient management decisions in acute care settings. The system utilizes simple cuvette-based technology to measure fibrin formation, ensuring faster true fibrin clot detection compared to other systems. This enables healthcare professionals to make timely dose adjustments and clinical decisions based on reliable data. The system’s standardization of ACT, ACT-LR, PT, and APTT testing at the point of care contributes to the consistency and reliability of results, enhancing the quality of patient care.
Testing Capabilities
The Hemochron Signature Elite specializes in rapid whole blood testing. It standardizes ACT, ACT-LR, PT, and APTT testing. The system provides results for patient management decisions.
ACT and ACT-LR Testing
The Hemochron Signature Elite system offers comprehensive capabilities for ACT and ACT-LR testing, essential for monitoring heparin’s effects. ACT accurately measures heparin effects (1.0-6.0 u/mL blood), while ACT-LR, sensitive to low heparin doses (0.0-2.5 u/mL blood), is ideal for procedures like ECLS, Hemodialysis and PTCA. The system standardizes rapid whole blood hemostasis testing, providing quick results for dose adjustments and clinical decisions. The Signature Elite utilizes cuvette-based technology to measure fibrin formation, ensuring reliable outcomes in various point-of-care settings. The system simplifies activated clotting time measurements.
PT and APTT Testing
The Hemochron Signature Elite extends its testing capabilities to include PT and APTT assays, crucial for assessing coagulation pathways. PT/Citrate PT and APTT/Citrate APTT reports INR, plasma-equivalent seconds, with an effective INR range of 0.8-10.0. Fast and reproducible results are essential for dose adjustments and clinical decisions. The system uses a simple cuvette-based technology to measure fibrin formation. The Hemochron Signature Elite system provides standardized PT and APTT testing at the point of care. It is ideal across a range of POC settings: Cardiovascular Operating Room, Cardiac Catheterization Lab, Emergency Department.
Operation and Use
The Hemochron Signature Elite is designed for ease of use. A test cuvette is inserted into the test chamber to measure the clotting time of whole blood in minutes.
Trained Healthcare Professionals
The HEMOCHRON Signature Elite instrument is intended for use by healthcare professionals who have received proper training and certification in its operation. Operation must align with established facility policies and procedures to ensure accurate and reliable results. Refer to the assay package insert for specific limitations. Proper training ensures the operator understands the instrument’s capabilities, limitations, and maintenance requirements. This contributes to patient safety and optimal performance. Following the operator’s manual ensures correct operation and reduces the risk of errors.
Sample Types
The Hemochron Signature Elite is designed to analyze both fresh and citrated whole blood samples. The system’s versatility in accepting these sample types makes it suitable for various point-of-care settings; This allows for testing to be performed directly at the patient’s side, minimizing turnaround time and improving clinical decision-making. Fresh whole blood provides an immediate snapshot of the patient’s coagulation status, while citrated samples offer a stabilized option when immediate analysis is not possible. Both sample types contribute to the system’s flexibility and utility in acute care environments.
Connectivity and Compliance
The Hemochron Signature Elite provides comprehensive connectivity and compliance. It stores 600 patient and QC test results. Automatic tagging of test results with date and time enhances data management capabilities.
Data Management
To maximize efficiency, the Hemochron Signature Elite offers comprehensive data management capabilities, ensuring regulatory compliance. It features automatic internal electronic QC with lockout for cuvette and QC expiration. There is also operator tracking and lockout functionalities. The system allows direct connection to Ethernet and major data management systems. It is also POCT-1A compliant. The device stores 600 patient and QC test results, and automatically tags test results with date and time. Users can scan or manually enter up to 16 alphanumeric characters.
Regulatory Compliance
Ensuring adherence to industry standards, the Hemochron Signature Elite incorporates comprehensive connectivity and compliance technology. The system is designed to meet the rigorous demands of point-of-care testing environments. It provides automatic internal electronic QC with lockout functionality for cuvette and QC expiration, as well as operator tracking. The Hemochron Signature Elite is POCT-1A compliant, facilitating seamless integration with hospital information systems. These features are crucial for maintaining accurate records, complying with regulatory requirements, and ensuring patient safety in acute care settings.
Applications
The Hemochron Signature Elite is ideal for settings like the Cardiovascular Operating Room and Cardiac Catheterization Lab. It is also perfect for the Emergency Department, and the Intensive Care Unit.
Acute Care Settings
The Hemochron Signature Elite system is designed for rapid whole blood hemostasis testing in acute care settings. It is particularly useful in the Cardiovascular Operating Room, Cardiac Catheterization Lab, and Emergency Department. The system provides rapid, accurate, and reproducible results, crucial for patient management decisions. Clinicians can use it for dose adjustments and clinical decisions, with results faster than any other system. Its simplicity extends to any patient and any operator.
Maintenance and Troubleshooting
Refer to the operator’s manual for instructions on instrument preparation, quality control, and troubleshooting. The manual covers topics such as running a test and data management for the system.
Operator’s Manual
The Hemochron Signature Elite Operator’s Manual provides comprehensive instructions for using the Hemochron Signature Elite Whole Blood Microcoagulation System. This manual is a crucial resource for healthcare professionals trained and certified to operate the system. It covers essential topics such as instrument preparation, running tests, performing quality control procedures, and troubleshooting common issues. Refer to the manual for specific limitations. It also provides detailed guidance on data management and ensuring regulatory compliance. Proper adherence to the manual’s instructions ensures accurate and reliable results. This ensures optimal performance for hemostasis testing.
