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The ROTEM® delta Thromboelastometry System is designed for invitro diagnostic use by professionals in a laboratory environment. The ROTEM® system is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® system records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and Ivses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The ROTEM® system provides specific blood modifiers (so-called reagents) intended to be used with the system, as additive to the blood sample. The results of the ROTEM® analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history (anamnesis), the clinical picture and, if necessary, further coagulations tests. The ROTEM® delta is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis. ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. The in-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The hep-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, via the intrinsic pathway in the presence of unfractionated heparin, in citrated whole blood specimens. The hep-TEM® reagent is used to inactivate heparin in patients receiving unfractionated heparin. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The NATEM assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, contact-activated by the surface of the measurement cell, in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The star-TEM® Reagent is intended for use as a recalcification reagent in the NATEM and INTEM assays on the ROTEM® delta Thromboelastometry System.

The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM® hep-TEM®, star-TEM®), quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into an amplitude with the following definitions applying to the thromboelastogram (TEM): An amplitude of 0 mm means unobstructed rotation, while an amplitude of 100mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.