TEM-A the modular automated Thromboelastometer

1. An advanced P.O.C. instrument for monitoring haemostasis TEM-A the modular automated Thromboelastometer HEMOLOGIX

2. ..invented by Eng. H. Hartert around 1949.. …thromboelastography has rapidly developed in recent years as the POC method of choice for effectively monitoring blood coagulation by verifying the dynamical development of its mechanical behaviour HEMOLOGIX

3. Clot is a mechanical cork.. ...therefore knowing how this cork develops in time and strength leads to identifying the possible underlining problems… …TEM-A provides informations on the QUALITY of the clot resulting from the interaction of the QUANTITIES of blood components…the final answer… HEMOLOGIX

4. From the graphical datathat need interpretation.. ..in the 60’s labs moved from the thromboelastogram to the more detailed analytical datas that were necessary to identify CHRONICc endogenous disfunctions of haemostasis…because… HEMOLOGIX

5. Thecoagulationcascade.....apparentlysimple.. HEMOLOGIX

6. ..instead is rather complicated....and the clot is the result of the balance - or imbalance - of numerous contrasting actions..…that form an elastic mechanical cork..IEM-A monitors the formation and functionality of this cork....but no single element of this cascade ……….

7. Some of the events that can cause acute changes in haemostasis : • surgery • trauma • partum • changes induced by pharmacotherapy HEMOLOGIX

8. …from the analytical lab data to the synthetic data of the TEM-A.. ..from the thromboelastogram labs moved to the more detailed analytical data, that were necessary to identify CHRONIC endogenous disfunctions of haemostasis.. …and now we go back to the synthetic results of thromboelastometry to face the ACUTE disfunctions of haemostasis caused by external events HEMOLOGIX

9. Why Thromboelastometry ? • The original instrument operated manually and reported the sensor’s data as a graph that needed interpretation • The thromboelastometer uses computerisation to manage the operations, to measure and to expose parametric data and related graphics. HEMOLOGIX

10. The TEM-A technology • A pin suspended from a free wire is immersed in an oscillating cup containing a blood sample. As the blood coagulates it will drive the pin to follow the oscillation of the cup generating a dynamic trace HEMOLOGIX

11. Why TEM-A ? • The thromboelastographic instrument requires careful manual operations and attentions that are time consuming in the OR and ICU, where actions must be prompt. • TEM-A adds to tromboelastography the automation of the manual phases ed eliminates those that require special attention HEMOLOGIX

12. Why free wire and oscillating cup • The free wire has the task of transmitting the movement, secondary to coagulation, generated by the clot as it hardens inside the oscillating cup (primary movement) • If the cup was still and the wire oscillating, there would be a sensor which causes the primary movement and at the same time measure the secondary one, with low reliability due to the superimposition of both functions HEMOLOGIX

13. The TEM-A : • Modular • Up to 4 analytical ports • Thermal regulation • Automatic positioning • incorporates PC • Mouse controlled • Automatic zero-cal before every test HEMOLOGIX

14. How many analytical ports ? • TEM-A can be supplied with the necessary number of analytical stations, from 1 to 4, depending on the customer needs, without altering its dimensions. • Every station is autonomous • The automatic loading eliminates the possibility of altering by vibration a current test while loading a new test HEMOLOGIX

15. Often one analysis channel is sufficient MonoTEMA is a covenient single module with all the benefits of the TEM-A HEMOLOGIX

16. MonoTEM-A single channel • In many situations one analysis channel is a sufficient diagnostic support. • Economical and with the same features of the TEM-A, or as an entry to the use of thromboelastography. • Uses your own PC. HEMOLOGIX

17. The TEM-A and MonoTema advantages • Automatic loading and positioning of disposables and sample • Continuous protection of the delicate sensor, blocked when not in use • Zero autocal before every test HEMOLOGIX

18. The TEM-A advantages • Integral computer, display, power supply and a/d interface. No cables around. • Easy loading of the sample • One simple operator interface : mouse • Virtual keyboard • Can be used also by paramedics HEMOLOGIX

19. The TEM-A advantages : the integral display HEMOLOGIX

20. The TEM-A advantages : loading of the sample HEMOLOGIX

21. Or the convenient MonoTEM-A HEMOLOGIX

22. MonoTEM-A is a low-cost single-channel ThromboElastoMeter-Automated Same features as the TEM-A Up to 4 MonoTEM-A can be used with any existing PC or notebook Includes TemaWin software Easily moved to different locations HEMOLOGIX

23. What is measured by TEM-A ? • The clot is a multidirectional network (of fibrin and platelets), like a sponge • In physics the main property of a network is its elasticity • Elasticity is the ability to deform and return to the original morphology HEMOLOGIX

24. What is measured by TEM-A ? • Viscosity is the resistance to deformation caused by contiguous material • Viscosity and density are secondary properties of elasticity, that do not define the functionality of a network HEMOLOGIX

25. This is what the TEM-A measures : • The thromboelastometer measures the main property of the network, its elasticity • It provides measurements of times and mechanical strengths of the clot as it forms in an environment similar to that of a blood vessel HEMOLOGIX

26. Cinetics of the clot R = reaction time K = time to 20mm amplitude MA = Maximum Amplitude alfa = speed of aggregation

27. TEMA provides informations on the clot’s dynamics even beyond those provided by standard lab tests After the first formation of fibrin strains the standard lab tests can provide only platelets count, but no infomation on their quality. D-dimers are unreliable HEMOLOGIX

28. Dynamic representation of the formation of the clot Analysis of the global functionality of haemostasis resulting from contrasting activities QUALITATIVE ANALYSIS Static representation of phases of haemostasis Analysis of some of the individual phenomena of the cascade QUANTITATIVE ANALYSIS TEM-A : Lab : HEMOLOGIX

29. Other parameters from TEM-A TEM-A and MonoTema provide also: Amplitude at 10, 20 and 60 minutes A10/A20 catch hypo/hyper coagulations and with A60 allow improved comparisons. HEMOLOGIX

30. Every morphologyhas itssignificance HEMOLOGIX

31. Celite or kaolin activate the process and shorten the response time heparinase allows the test to be done also for heparinased blood Antiaggregants can evaluate the sole influence of platelets other in vitro modifications can help to evaluate the therapeutic efficacy Specific reagents can pre- modify the blood sample : HEMOLOGIX

32. Available disposables and reagents : • Untreated plastic cups and pins • Heparinase vials • Kaolin activator • CaCl2 • TemaTrol for Quality Control HEMOLOGIX

33. TEM-A with citrated blood reconstituted with CaCl : - when/where the test is not urgent or the sample is available only at a distance of over 4 minutes HEMOLOGIX

34. A standard protocol is needed for reproducibility : • Times and methods of sampling • Time to start the TEM-A (r=2mm/min) • The automatic loading, instead of manual, contributes to standardise the use and to reproducibility HEMOLOGIX

35. The time to R (t2R) : • To promote adherence to a protocol the software TemaWin allows entry of the time occurred from draw to Start of the test in a “t2R” box, together with the demographics of the patient. “t2R” is archived with the analysis to allow better evaluation of the R parameter. HEMOLOGIX

36. Quality Control : • Automatic zero calibration at every test • End scale preset at factory • TemaTrol, a fully vegetable Quality Control that mimics the behaviour of blood HEMOLOGIX

37. Periodic calibrations : • No daily manual calibration needed • TEM-A autocalibrates zero before every test; endscale precalibrated • Use TemaTrol monthly or when in doubt. Checks zero and mid-point. HEMOLOGIX

38. Applicable in several hospital areas : • Liver transplant, cardiosurgery • Obstetrics • Trauma, ortopedics and neurosurgery • Cardiology • Wherever a functional evaluation of heamostasis may be needed HEMOLOGIX

39. Validation • Today there is a miryad of publications on thromboelastography with the Hartert method and its applications • Internet search engine : “Thromboelastography” HEMOLOGIX

40. Who uses thromboelastometry ? • Almost all liver transplant units • Many cardiosurgeries • known and used throughout the world. HEMOLOGIX

41. TEM-A easily allows to monitor the FUNCTIONAL state of patient’s haemostasis • Immediately (P.O.C.) • Even on heparinised patients (ECC) • Identifies the effect of acute disorders on the resulting clot • Convalidates with more certainty therapies that are often deductive HEMOLOGIX

42. Benefits for the anesthesist : - more data for diagnosis fast response allows immediate therapy ease of use by all personnel HEMOLOGIX

43. Benefits for the surgeon: - limited bring-backs and only if confirmed - better outcome HEMOLOGIX

44. Benefits for the patient : - less exposure to risks related to trasnfusions - increased probability of success HEMOLOGIX

45. Economic benefits : - lower use of blood products and pharmaceuticals - elimination of unnecessary bring-backs HEMOLOGIX

46. TEM-A for thromboelastometry. ..modularity and automation…. …easier operation.. …a better product by Framar Biomedica HEMOLOGIX