TEM-A the automated module for thromboelastography An advanced P.O.C. instrument for monitoring haemostasis HEMOLOGIX

..invented by Eng. H. Hartert around …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

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

From the graphical data that needed interpretation....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

The coagulation cascade.....apparently simple.. HEMOLOGIX

..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.. TEM-A monitors the formation and functionality of this cork....but no single element of this cascade HEMOLOGIX ……….

Some of the events that can cause acute changes in haemostasis : surgery trauma Partum Sepsis changes induced by pharmacotherapy HEMOLOGIX

…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

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

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

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

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

The MultiTEM-A : Modular, expandable Up to 4 indipendent analytical ports Individual thermal regulation Automatic sample positioning Automatic zero-cal before every test Mouse controlled No tools to load/unload HEMOLOGIX

How many analytical ports ? MultiTEM-A can be supplied with the necessary number of analytical stations, from 1 to 4, depending on the user needs, without altering its dimensions. It can be easily expanded up to 4 indipendent modules at any later time Every station is an autonomous module with individual thermal selection and control The automatic loading eliminates the possibility of altering by vibration a current test while loading a new test With the user friendly TEMAWin software, one PC controls all installed modules HEMOLOGIX

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

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

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

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

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

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

Or the convenient MonoTEMA HEMOLOGIX

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

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

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

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

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

Kinetics of the clot Kinetics of the clot R = reaction time K = time to 20mm amplitude MA = Maximum Amplitude  = speed of aggregation HEMOLOGIX

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

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

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

Every morphology has its significance HEMOLOGIX HEMOLOGIX

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

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

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

A standard protocol of pre-test procedures is necessary 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

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

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

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

Applicable in several hospital areas where haemostasis is a key factor : Liver transplant, cardiosurgery Obstetrics GY (Pre-post partum, DIC) Trauma, ortopedics and neurosurgery Cardiology, Vascular Laboratory, Blood Bank General medicine (sepsis, dengue) HEMOLOGIX

Validation Today there is a miryad of scientific publications on thromboelastography with the Hartert method and its applications Whether it is called thromboelastography or thromboelastometry, tromboelastografia or tromboelastometria, thromboelastographie or thromboelastometrie, whether it is a thromboelastograph, a thromboelastometer, a tromboelastografo or tromboelastometro, this instrument and its analysis are accepted and used throughout the world. HEMOLOGIX

TEM-A easily allows to monitor the functiona l 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

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

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

Benefits for the patient : - less exposure to risks related to transfusions - increased probability of therapeutical success HEMOLOGIX

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

TEM-A..modularity and automation…. …easier operation.. …a better product by Hemologix HEMOLOGIX