TEM-A the modular automated Thromboelastometer

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TEM-A the modular
automated Thromboelastometer

• An advanced P.O.C. instrument for
• monitoring haemostasis

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..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

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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 componentsthe final answer

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From the graphical datathat need interpretation..

• ..in the 60s labs moved from the
  thromboelastogram to the more detailed analytical
  datas that were necessary to identify CHRONICc
  endogenous disfunctions of haemostasisbecause

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Thecoagulationcascade.....apparentlysimple..
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..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

• .

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Some of the events that can cause acute changes
in haemostasis

• surgery
• trauma
• partum
• changes induced by pharmacotherapy

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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

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Why Thromboelastometry ?

• The original instrument operated manually and
  reported the sensors 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.

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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 ?

• 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

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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

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The TEM-A

• Modular
• Up to 4 analytical ports
• Thermal regulation
• Automatic positioning
• incorporates PC
• Mouse controlled
• Automatic zero-cal before every test

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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

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Often one analysis channel is sufficient

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

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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.

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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

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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

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The TEM-A advantages the integral display
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The TEM-A advantages loading of the sample
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Or the convenient MonoTEM-A
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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

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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

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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

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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

• R reaction time K time to 20mm amplitude
• MA Maximum Amplitude alfa speed of
  aggregation

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• TEMA provides informations on the clots 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

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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

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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.

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Every morphologyhas itssignificance
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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

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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

• - 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

• Times and methods of sampling
• Time to start the TEM-A (r2mm/min)
• The automatic loading, instead of manual,
  contributes to standardise the use and to
  reproducibility

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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

• 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

• 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.

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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

• 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 ?

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

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TEM-A easily allows to monitor the FUNCTIONAL
state of patients 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

• - more data for diagnosis
• fast response allows immediate therapy
• ease of use by all personnel

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Benefits for the surgeon

• - limited bring-backs and only if confirmed
• - better outcome

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Benefits for the patient

• - less exposure to risks related to trasnfusions
• - increased probability of success

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Economic benefits

• - lower use of blood products and pharmaceuticals
  
• - elimination of unnecessary bring-backs

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TEM-A for thromboelastometry.

• ..modularity and automation.
• easier operation..
• a better product by Framar Biomedica