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TEM-A TEM-A the modular automated the modular automated Thromboelastometer Thromboelastometer

An advanced P.O.C. instrument forAn advanced P.O.C. instrument for

monitoring haemostasis monitoring haemostasis

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..invented by Eng. ..invented by Eng. H. Hartert around H. Hartert around 1949..1949..

……thromboelastography has rapidly developed in thromboelastography has rapidly developed in recent years as the POC method of choice for recent years as the POC method of choice for effectively monitoring blood coagulation by effectively monitoring blood coagulation by verifying the dynamical development of its verifying the dynamical development of its mechanical behaviourmechanical behaviour

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Clot is a mechanical Clot is a mechanical cork..cork..

...therefore knowing how this cork develops ...therefore knowing how this cork develops in time and strength leads to identifying in time and strength leads to identifying the possible underlining problems…the possible underlining problems…

……TEM-A provides informations on the TEM-A provides informations on the QUALITY of the clot resulting from the QUALITY of the clot resulting from the interaction of the QUANTITIES of blood interaction of the QUANTITIES of blood components…the final answer…components…the final answer…

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From the graphical dataFrom the graphical datathat need interpretation..that 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…

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TheThecoagulationcoagulationcascade...cascade...

..apparently..apparentlysimple..simple..

..instead is rather ..instead is rather complicated..complicated....and the clot is the result ..and the clot is the result of the balance - or of the balance - or imbalance - of numerous imbalance - of numerous contrasting actions..contrasting actions..

…that form an elastic …that form an elastic mechanical cork..mechanical cork..

IEM-A monitors the IEM-A monitors the formation and formation and functionality of this cork..functionality of this cork..

..but no single element of ..but no single element of this cascadethis cascade

………………..

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Some of the events that Some of the events that can cause acute changes can cause acute changes in haemostasis :in haemostasis :

surgerysurgery traumatrauma partumpartum changes induced by pharmacotherapy changes induced by pharmacotherapy

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……from the analytical lab from the analytical lab data to the synthetic data data to the synthetic data of theof the TEM-A.. 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

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Why ThromboelastometryWhy Thromboelastometry ? ?

The original instrument operated The original instrument operated manually and reported the sensor’s manually and reported the sensor’s data as a graph that needed data as a graph that needed interpretationinterpretation

The thromboelastometer uses The thromboelastometer uses computerisation to manage the computerisation to manage the operations, to measure and to expose operations, to measure and to expose parametric data and related graphics.parametric data and related graphics.

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The TEM-A The TEM-A technologytechnology A pin suspended A pin suspended

from a free wire from a free wire is immersed in is immersed in an oscillating an oscillating cup containing a cup containing a blood sample. blood sample. As the blood As the blood coagulates it will coagulates it will drive the pin to drive the pin to follow the follow the oscillation of the oscillation of the cup generating a cup generating a dynamic tracedynamic trace

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Why TEM-A ?Why TEM-A ?

The thromboelastographic instrument The thromboelastographic instrument requires careful manual operations and requires careful manual operations and attentions that are time consuming in the attentions that are time consuming in the OR and ICU, where actions must be OR and ICU, where actions must be prompt.prompt.

TEM-A adds to tromboelastography the TEM-A adds to tromboelastography the automation of the manual phases ed automation of the manual phases ed eliminates those that require special eliminates those that require special attentionattention

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Why free wire andWhy free wire and oscillating cup oscillating cup

The free wire has the task of transmitting the The free wire has the task of transmitting the movement, secondary to coagulation, movement, secondary to coagulation, generated by the clot as it hardens inside the generated by the clot as it hardens inside the oscillating cup (primary movement)oscillating cup (primary movement)

If the cup was still and the wire oscillating, If the cup was still and the wire oscillating, there would be a sensor which causes the there would be a sensor which causes the primary movement and at the same time primary movement and at the same time measure the secondary one, with low reliability measure the secondary one, with low reliability due to the superimposition of both functionsdue to the superimposition of both functions

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The TEM-A :The TEM-A :

ModularModular Up to 4 analytical portsUp to 4 analytical ports Thermal regulationThermal regulation Automatic positioningAutomatic positioning incorporates PCincorporates PC Mouse controlledMouse controlled Automatic zero-cal Automatic zero-cal

before every testbefore every test

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How many analytical ports ?How many analytical ports ?

TEM-A can be supplied with the necessary TEM-A can be supplied with the necessary number of analytical stations, from 1 to 4, number of analytical stations, from 1 to 4, depending on the customer needs, without depending on the customer needs, without altering its dimensions.altering its dimensions.

Every station is autonomousEvery station is autonomous The automatic loading eliminates the possibility The automatic loading eliminates the possibility

of altering by vibration a current test while of altering by vibration a current test while loading a new testloading a new test

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Often one analysis channel is Often one analysis channel is sufficientsufficient

MonoTEMA is a MonoTEMA is a covenient single covenient single module with all module with all the benefits of the benefits of the TEM-A the TEM-A

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MonoTEM-A single channelMonoTEM-A single channel

In many situations one analysis channel In many situations one analysis channel is a sufficient diagnostic support.is a sufficient diagnostic support.

Economical and with the same features Economical and with the same features of the TEM-A, or as an entry to the use of of the TEM-A, or as an entry to the use of thromboelastography. thromboelastography.

Uses your own PC.Uses your own PC.

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The TEM-A and MonoTema The TEM-A and MonoTema advantagesadvantages

Automatic loading and positioning of Automatic loading and positioning of disposables and sampledisposables and sample

Continuous protection of the delicate Continuous protection of the delicate sensor, blocked when not in usesensor, blocked when not in use

Zero autocal before every testZero autocal before every test

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The TEM-A advantagesThe TEM-A advantages

Integral computer, display, power supply Integral computer, display, power supply and a/d interface. No cables around.and a/d interface. No cables around.

Easy loading of the sampleEasy loading of the sample One simple operator interface : mouseOne simple operator interface : mouse Virtual keyboardVirtual keyboard Can be used also by paramedicsCan be used also by paramedics

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The TEM-A advantages : The TEM-A advantages : the integral displaythe integral display

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The TEM-A advantages : The TEM-A advantages : loading of the sampleloading of the sample

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Or the convenient Or the convenient MonoTEM-AMonoTEM-A

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MonoTEM-A is a low-cost single-channel MonoTEM-A is a low-cost single-channel ThromboElastoMeter-AutomatedThromboElastoMeter-Automated

Same features as the TEM-ASame features as the TEM-A Up to 4 MonoTEM-A can be used with Up to 4 MonoTEM-A can be used with

any existing PC or notebookany existing PC or notebook Includes TemaWin softwareIncludes TemaWin software Easily moved to different locationsEasily moved to different locations

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What is measured by TEM-A ?What is measured by TEM-A ?

The clot is a multidirectional network (of The clot is a multidirectional network (of fibrin and platelets), like a sponge fibrin and platelets), like a sponge

In physics the main property of a network In physics the main property of a network is its elasticityis its elasticity

Elasticity is the ability to deform and Elasticity is the ability to deform and return to the original morphologyreturn to the original morphology

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What is measured by TEM-A ?What is measured by TEM-A ?

Viscosity is the resistance to deformation Viscosity is the resistance to deformation caused by contiguous materialcaused by contiguous material

Viscosity and density are secondary Viscosity and density are secondary properties of elasticity, that do not define properties of elasticity, that do not define the functionality of a networkthe functionality of a network

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This is what the TEM-A This is what the TEM-A measures :measures :

The thromboThe thromboelastometer measures the elastometer measures the main property of the network, its elasticity main property of the network, its elasticity

It provides measurements of times and It provides measurements of times and mechanical strengths of the clot as it mechanical strengths of the clot as it forms in an environment similar to that of forms in an environment similar to that of a blood vessela blood vessel

Cinetics of the clotCinetics of the clot

R = reaction time R = reaction time K = time to 20mm amplitude K = time to 20mm amplitude

MA = Maximum Amplitude alfa = speed of aggregationMA = Maximum Amplitude alfa = speed of aggregation

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TEMA TEMA provides provides informationinformations on the s on the clot’s clot’s dynamics dynamics even even beyond beyond those those provided provided by by standard standard lab testslab tests

After the first After the first formation of formation of fibrin strains fibrin strains the standard the standard lab tests can lab tests can provide only provide only platelets platelets count, but no count, but no infomation infomation on their on their quality. D-quality. D-dimers are dimers are unreliableunreliable

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TEM-A : Lab :TEM-A : Lab :

Dynamic representation of Dynamic representation of the formation of the clotthe formation of the clot

Analysis of the global Analysis of the global functionality of functionality of haemostasis resulting from haemostasis resulting from contrasting activitiescontrasting activities

QUALITATIVE ANALYSISQUALITATIVE ANALYSIS

Static representation of Static representation of phases of haemostasisphases of haemostasis

Analysis of some of the Analysis of some of the individual phenomena of individual phenomena of the cascadethe cascade

QUANTITATIVE QUANTITATIVE ANALYSISANALYSIS

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Other parameters Other parameters from TEM-Afrom TEM-ATEM-A and MonoTema provide also:TEM-A and MonoTema provide also:

-Amplitude at 10, 20 and 60 minutesAmplitude at 10, 20 and 60 minutes

A10/A20 catch hypo/hyper coagulations and A10/A20 catch hypo/hyper coagulations and

with A60 allow improved comparisons.with A60 allow improved comparisons.

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Every Every morphologymorphologyhas itshas itssignificancesignificance

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Specific reagents can Specific reagents can pre- modify the blood pre- modify the blood sample :sample :

Celite or kaolin Celite or kaolin activate the process activate the process and shorten the and shorten the response timeresponse time

heparinase allows heparinase allows the test to be done the test to be done also for heparinased also for heparinased bloodblood

Antiaggregants can Antiaggregants can evaluate the sole evaluate the sole influence of plateletsinfluence of platelets

other in vitro other in vitro modifications can modifications can help to evaluate the help to evaluate the therapeutic efficacytherapeutic efficacy

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Available disposables and Available disposables and reagents :reagents :

Untreated plastic cups and pinsUntreated plastic cups and pins Heparinase vialsHeparinase vials Kaolin activatorKaolin activator CaCl2CaCl2 TemaTrol for Quality ControlTemaTrol for Quality Control

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TEM-A with TEM-A with citrated blood citrated blood reconstituted with reconstituted with CaCl :CaCl :

- when/where the test is not urgent - when/where the test is not urgent or the sample is available only at a or the sample is available only at a distance of over 4 minutesdistance of over 4 minutes

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A standard protocol is needed A standard protocol is needed for reproducibility :for reproducibility :

Times and methods of samplingTimes and methods of sampling Time to start the TEM-A Time to start the TEM-A (r=2mm/min)(r=2mm/min)

The automatic loading, instead of The automatic loading, instead of manual, contributes to standardise manual, contributes to standardise the use and to reproducibilitythe use and to reproducibility

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The time to R (t2R) :The time to R (t2R) :

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

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Quality Control :Quality Control :

Automatic zero calibration at every testAutomatic zero calibration at every test End scale preset at factory End scale preset at factory TemaTrol, a fully vegetable Quality TemaTrol, a fully vegetable Quality

Control that mimics the behaviour of Control that mimics the behaviour of bloodblood

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Periodic calibrations :Periodic calibrations :

No daily manual calibration neededNo daily manual calibration needed TEM-A autocalibrates zero before every TEM-A autocalibrates zero before every

test; endscale precalibratedtest; endscale precalibrated Use TemaTrol monthly or when in doubt. Use TemaTrol monthly or when in doubt.

Checks zero and mid-point. Checks zero and mid-point.

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Applicable in several Applicable in several hospital areas :hospital areas :

Liver transplant, cardiosurgeryLiver transplant, cardiosurgery ObstetricsObstetrics Trauma, ortopedics and neurosurgeryTrauma, ortopedics and neurosurgery CardiologyCardiology Wherever a functional evaluation of Wherever a functional evaluation of

heamostasis may be neededheamostasis may be needed

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ValidationValidation

Today there is a miryad of publications Today there is a miryad of publications on thromboelastography with the Hartert on thromboelastography with the Hartert method and its applicationsmethod and its applications

Internet search engine : Internet search engine : “Thromboelastography”“Thromboelastography”

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Who uses Who uses thromboelastometry ?thromboelastometry ?

Almost all liver transplant unitsAlmost all liver transplant units Many cardiosurgeriesMany cardiosurgeries known and used throughout the world.known and used throughout the world.

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TEM-A easily allows to monitor the TEM-A easily allows to monitor the FUNCTIONAL state of patient’s FUNCTIONAL state of patient’s haemostasishaemostasis

Immediately (P.O.C.)Immediately (P.O.C.) Even on heparinised patients (ECC)Even on heparinised patients (ECC) Identifies the effect of acute disorders on Identifies the effect of acute disorders on

the resulting clot the resulting clot Convalidates with more certainty Convalidates with more certainty

therapies that are often deductivetherapies that are often deductive

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

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

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Benefits for the Benefits for the patient :patient :- less exposure to risks related to - less exposure to risks related to trasnfusions trasnfusions

- increased probability of success- increased probability of success

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Economic benefits :Economic benefits :

- lower use of blood products and - lower use of blood products and pharmaceuticals pharmaceuticals

- elimination of unnecessary bring-- elimination of unnecessary bring-backsbacks

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TEM-A for thromboelastometry.TEM-A for thromboelastometry.

..modularity and automation…...modularity and automation….

… …easier operation..easier operation..

… …a a betterbetter product by Framar Biomedica product by Framar Biomedica