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An advanced P.O.C. instrument for monitoring haemostasis. TEM-A the modular automated Thromboelastometer. ..invented by Eng. H. Hartert around 1949.

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tem a the modular automated thromboelastometer
An advanced P.O.C. instrument for

monitoring haemostasis

TEM-A the modular automated Thromboelastometer

HEMOLOGIX

invented by eng h hartert around 1949

..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

clot is a mechanical cork
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

from the graphical data that need interpretation
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

slide6

..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

……….

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

HEMOLOGIX

from the analytical lab data to the synthetic data of the tem a
…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
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

the tem a technology
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

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why tem a
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

why free wire and oscillating cup
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

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

HEMOLOGIX

how many analytical ports
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

often one analysis channel is sufficient
Often one analysis channel is sufficient

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

HEMOLOGIX

monotem a single channel
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

the tem a and monotema advantages
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

the tem a advantages
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

monotem a is a low cost single channel thromboelastometer automated
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

what is measured by tem a
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

what is measured by tem a1
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

this is what the tem a measures
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

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cinetics of the clot
Cinetics of the clot

R = reaction time K = time to 20mm amplitude

MA = Maximum Amplitude alfa = speed of aggregation

slide27
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

tem a lab
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

other parameters from tem a

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

specific reagents can pre modify the blood sample
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

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

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tem a with citrated blood reconstituted with cacl

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

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a standard protocol is needed for reproducibility
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

the time to r t2r
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.

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quality control
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

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

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

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

HEMOLOGIX

tem a easily allows to monitor the functional state of patient s haemostasis
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

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benefits for the anesthesist

Benefits for the anesthesist :

- more data for diagnosis

fast response allows immediate therapy

ease of use by all personnel

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benefits for the surgeon

Benefits for the surgeon:

- limited bring-backs and only if confirmed

- better outcome

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benefits for the patient

Benefits for the patient :

- less exposure to risks related to trasnfusions

- increased probability of success

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economic benefits

Economic benefits :

- lower use of blood products and pharmaceuticals

- elimination of unnecessary bring-backs

HEMOLOGIX

tem a for thromboelastometry
TEM-A for thromboelastometry.

..modularity and automation….

…easier operation..

…a better product by Framar Biomedica

HEMOLOGIX