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The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications. Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files. Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.

The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

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The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.

The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoaqulation frequently associated with cardiovascular surgery. The test is to be used with the i-STAT Portable Clinical Analyzer (Models 200 and 300), but not the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the Kaolin ACT test is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures.

The i-STAT Kaolin ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge is inserted into the thermally controlled i-STAT Model 200 or Model 300 Portable Clinical Analyzer, and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes an activating agent, a thrombin substrate, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation. In the i-STAT ACT test, the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The reported result is calculated from the time and rate of the substrate conversion and is given in seconds. The reported result correlates to the result of a traditional ACT in which the endpoint is indicated by physical clot formation.

The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

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ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for use in a near-patient or patient-care environment.

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The Rapidpoint Low range Heparin Management Test Card is to be used with the Rapidpoint Coag (formerly TAS) Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures. The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin.

The Rapidpoint LHMT provides a method to measure the response of a patient to heparin. A noncitrated whole blood sample can be used for this test. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample flows into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

The i-STAT Celite Activated Clotting Time (ACT) test cartridge is an in vitro diagnostic test used to monitor moderate- and high-level hevarin therapy through analysis of arterial and venous whole blood samples. The cartridge is to be used with the i-STAT System 200 model analyzer. As part of the i-STAT System, the Celite ACT test cartridge is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures. The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis.

The i-STAT Celite ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 Portable Clinical Analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. In the i-STAT ACT test the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The reported result is calculated from the time and rate of the substrate conversion and is given in seconds. The reported result correlates to the result of a traditional ACT in which the endpoint is indicated by physical clot formation. The ACT cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. The coagulation test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge. In the ACT cartridge the sensor comprises a gold film patterned on a silicon/silicon dioxide substrate. During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes an activating agent, a thrombin substrate, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation. Whole blood is introduced into the sample well of the cartridge at the sample port and the cartridge is closed and inserted into the analyzer. Insertion of the cartridge initiates a controlled and monitored sequence of steps in the instrument. These are: - Electrical contact is made between the analyzer electronic input circuits and the cartridge. The analyzer identifies the type of cartridge being used and the tests contained in the cartridge. - The dry chips and sensor channel are heated to 37C. - The blood is then moved forward. Feedback from the fluid position sensor is used to allow controlled oscillation of the blood segment resulting in dissolution of the reagent layer. - Following mixing, a count up time is displayed. - During the course of testing, the position of the blood segment is actively controlled to maintain the length of the blood containing the reagent coincident with the endpoint detector. - Calculation of sample clot time is performed and displayed.

The CoaguChek Pro ACT test is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

The activated clotting time test is used to measure coagulation by activating the clotting pathway. The ACT test monitors the effectiveness of heparin during several types of medical procedures. Many procedures such as Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation (ECMO) require the administration of low to moderate heparin doses. Sensitivity to heparin can vary significantly from patient to patient, and lack of adequate control of the heparin dose can lead to either bleeding or thrombosis. The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the activated clotting time. The displayed result is equivalent to the ACT result obtained from a commercially available system. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.