Transcript Tromboelastometro ( TEM-A )

TEM-A
the modular automated
Thromboelastometer
An advanced P.O.C. instrument for
monitoring haemostasis
HEMOLOGIX
..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
components…the final answer…
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From the graphical data
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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The
coagulation
cascade...
..apparently
simple..
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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
Some of the events that
can cause acute changes
in haemostasis :
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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 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.
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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 :
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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 singlechannel ThromboElastoMeterAutomated
 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
 TEMA
provides
informatio
ns 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. Ddimers 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
 Static representation of
phases of haemostasis
 Analysis of some of the
individual phenomena of
the cascade
 QUALITATIVE ANALYSIS
 QUANTITATIVE
ANALYSIS
HEMOLOGIX
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
morphology
has its
significance
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Specific reagents can premodify 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 :
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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 (r=2mm/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.
HEMOLOGIX
Applicable in several
hospital areas :
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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 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 :
- 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 bringbacks
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TEM-A for thromboelastometry.
..modularity and automation….
…easier operation..
…a better product by Framar Biomedica
HEMOLOGIX