TEM-A the automated module for thromboelastography

1. TEM-A the automated module for thromboelastography An advanced P.O.C. instrument for monitoring haemostasis 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 information on the QUALITY of the clot resulting from the interaction of the QUANTITIES of blood components… …the final answer… HEMOLOGIX

4. From the graphical datathatneededinterpretation.. ..in the 60’s labs moved from the thromboelastogram to the more detailed analytical data that were necessary to identify CHRONIC endogenous disfunctions of haemostasis… …BECAUSE… HEMOLOGIX

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

6. ..insteadisrathercomplicated....and the clotis the result of the balance - or imbalance - of numerouscontrastingactions……thatform an elasticmechanicalcork..TEM-A monitors the formation and functionality of thiscork....but no single element of thiscascadeHEMOLOGIX ……….

7. Some of the eventsthat can cause acute changes in haemostasis : • surgery • trauma • Partum • Sepsis • 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, the Hartert thromboelastograph, operated manually and reported optically the sensor’s data as a printed graph requiring interpretation • Today’s thromboelastometer uses computerisation to manage the operations, to measure electro-magnetically the sensor’s signal and to expose parametric data and the 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 the adhesion of its polymers will drive the pin to follow the oscillation of the cup generating a dynamic trace via an electro- magnetic sensor 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 and 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 measures the secondary effect, with low reliability due to the superimposition of both functions HEMOLOGIX

13. The MultiTEM-A : • Modular, expandable • Up to 4 indipendentanalyticalports • Individualthermalregulation • Automatic sample positioning • Automatic zero-calbeforeevery test • Mouse controlled • No tools to load/unload HEMOLOGIX

14. How many analytical ports ? • MultiTEM-A can be supplied with the necessarynumber of analyticalstations, from 1 to 4, depending on the userneeds, withoutalteringitsdimensions. • It can be easilyexpanded up to 4 indipendentmodulesatanylater time • Every station is an autonomousmodule with individualthermalselection and control • The automaticloadingeliminates the possibility of altering by vibration a current test whileloading a new test • With the userfriendlyTEMAWin software, one PC controlsallinstalledmodules HEMOLOGIX

15. Often one analysis channel is sufficient to benefit from thromboelastography MonoTEM-A is a convenient single station with the same benefits of the TEM-A module : HEMOLOGIX

16. MonoTEM-A single channel • Only one case of heamostatic disorders, even in heathcare areas where they are infrequent, can become dramatic…and very expensive • In the majority of situations one analysis channel is a sufficient and necessary diagnostic support…with limited investment. • Convenient and with the same features of the TEM-A module, or as an entry to an expanded use of thromboelastography. HEMOLOGIX

17. The MultiTEM-A and MonoTEM-A 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 MultiTEM-A advantages • Integral power supply and a/d interface. No cables around. Plug and USB for PC • Easy loading of the sample • One simple operator interface : mouse. No touching a screen with (stained?) gloves • Virtual keyboard • Easy to use by nursing staff HEMOLOGIX

19. The MultiTEM-A advantages : add the PC and display of your choice to up to 4 channels HEMOLOGIX

20. The MultiTEMA advantages : Sample carrier is exposed for easy pipetting of blood sample in the cup. Continued thermal control at all times, including pre-heating HEMOLOGIX HEMOLOGIX

21. Or the convenient MonoTEMA HEMOLOGIX

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

23. MonoTEM-A in OB/GY Pre-partum analysis by MonoTEM-A provides trend of patient’s heamostasis. Prior to delivery confirms its quality allowing regional anaesthesia even with poor PLT count. Post partum allows immediate diagnosis of a surgical problem (confirming function of haemostasis ) or prompt therapeutic intervention (DIC) HEMOLOGIX

24. What is measured by TEM-A modules? • 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

25. What is measured by TEM-A modules ? • 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

26. This is what TEM-A measures : • TEM-A 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

27. Kinetics of the clot R = reaction time K = time to 20mm amplitude MA = Maximum Amplitude a = speed of aggregation HEMOLOGIX

28. TEM-A provides information 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 platelet count, but no infomation on their quality. D-dimers are unreliable HEMOLOGIX

29. TEM-A : Lab : • Dynamic representation of the formation of the clot • Analysis of the global functionality of haemostasis resulting from contrasting activities • The only instrument that measures hypercoagulation and hyperfibrinolysis with certainty • QUALITATIVE ANALYSIS • Static representation of phases of haemostasis • Analysis of some of the individual phoenomena of the cascade • QUANTITATIVE ANALYSIS HEMOLOGIX

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

31. Every morphologyhas itssignificanceHEMOLOGIX HEMOLOGIX

32. Specific reagents can pre- modify the blood sample : • FAStema activates the process and shortens the response time • Heparinase allows the test to be done also on heparinased blood • CiTemA reconstitutes citrated blood • FibCHECK allows to measure the influence of only fibrinogen or platelets • ExWAY generates an immediate response for rapid evaluation of Maximum Amplitude HEMOLOGIX

33. Available disposables and reagents : • Untreated plastic cups and pins • Heparinase vials • Kaolin activator (FasTEMA) • CaCl2 (CiTEMA) • TemaTrol for Quality Control • Exway (immediate activator) • FibCheck to explore fibrinogen HEMOLOGIX

34. 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 With TEM-A modules it is possible to analyse either native or citrated blood samples HEMOLOGIX

35. A standard protocol of pre-test proceduresisnecessary for reproducibility : • Times and methods of sampling • Time to start the TEM-A • The automatic loading on the TEM-A, instead of manual, contributes to standardise the use and to obtain reproducibility HEMOLOGIX

36. 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

37. 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

38. 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

39. Applicable in several hospital areaswherehaemostasisis a keyfactor : • Liver transplant, cardiosurgery • Obstetrics GY (Pre-post partum, DIC) • Trauma, ortopedics and neurosurgery • Cardiology, Vascular • Laboratory, Blood Bank • General medicine (sepsis, dengue) HEMOLOGIX

40. Validation • Todaythereis a miryad of scientificpublications on thromboelastography with the Hartertmethod and itsapplications • Whetheritiscalledthromboelastography or thromboelastometry, tromboelastografia or tromboelastometria, thromboelastographie or thromboelastometrie, whetheritis a thromboelastograph, a thromboelastometer, a tromboelastografo or tromboelastometro, thisinstrument and itsanalysis are accepted and usedthroughout 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 anesthesiologist : - more data for diagnosis fast responseallows immediate therapy ease of use by allpersonnel HEMOLOGIX

43. Benefits for the surgeon: -limitedbring-backs, and onlyifconfirmed - betteroutcome HEMOLOGIX

44. Benefits for the patient : -lessexposure to risksrelated to transfusions - increasedprobability of therapeutical success HEMOLOGIX

45. Economic benefits : -lower use of bloodproducts and pharmaceuticals - elimination of unnecessarybring-backs HEMOLOGIX

46. TEM-A ..modularity and automation…. …easieroperation.. …a better product by Hemologix HEMOLOGIX