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| Is it a genuine medical test? |
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| The VariaCardio® TF5 is fully certified |
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| The TF5 is CE certified to the Medical
Devices Directive and is delivered by MIE Medical Research Ltd
which has ISO13488 accreditation. The TF5 has been in numerous
scientific studies where the results have been published in
learned medical and scientific peer reviewed journals. The TF5
fully complies with the recommendations laid down by the Special
Task Force Report by the European Society of Cardiology and
the North American Society of Pacing and Electrophysiology (1996)
on measuring Heart Rate Varaiability (HRV). |
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| The VariaCardio® TF5 is accurate |
Many people want to know if they are
at risk of developing heart disease. Ideally, they would like
a "green light – red light" indication showing
either “no risk” or “at risk”. However,
life is not like that. People develop heart disease over a period
of time. The VariaCardio® TF5 is able to show the early
onset of heart disease or your risk of developing heart disease.
This gives you and your physician as much time as possible to
do something about it before it is too late. To measure the
degree of risk requires a far more accurate and sensitive instrument.Accuracy
is therefore, very important. However, as HRV analysis relies
on either statistical analysis (time domain) or Fast Fourier
Transform analysis (frequency domain) the reliability of the
results relies very strongly on the quality of the data. If
artefacts or ectopic beats are included in the analysis, the
data can be so inaccurate that it shows a “green light”
instead of a “red light” situation. This is a particular
problem for any instrument that is unable to show the physician
the original ECG trace to check for signal quality.
Many doctors want to monitor progress of disease or treatment.
For example, some doctors use it to monitor the effects of cardiac
rehabilitation or medication therapy. Others use it to help
subjects stop smoking, loose weight or encourage them to exercise.
In these types of uses, the HRV monitor must be able to detect
small changes over relatively short periods of time. In order
to achieve this, the HRV monitor must be able to provide minimal
inter and intra operator error and to provide a high degree
of repeatability. The TF5, when used according to strictly standardised
protocols, is the only telemetric HRV analysis instrument that
is able to meet these demands.
Finally, when used as a research instrument, the quality of
the research results often depends on the objectivity of the
measurements, their accuracy and repeatability.Last but not
least, it is not only important to know the quality of the data
collected, but also to be able to edit out and/or replace any
poor quality data. The TF5 offers both automatic and manual
filters and data replacement procedures to facilitate the data
editing process.In conclusion, the TF5 is a superior instrument
to all Holter monitor devices, as it is the only proven instrument
that meets all the above stated criteria for measuring HRV.
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| Why is the VariaCardio® TF5 more accurate
than the Holter monitor? |
| Because the Holter monitor must record
over a 24-hour period, it is bound to collect data during a
variety of events. Such events include sleeping, going to the
toilet, eating, drinking, working, travelling, walking, driving
etc. Each of these and other events will have an effect on the
autonomic system. The results are therefore an average of all
of these events, which may mask the true functionality of the
control of the autonomic system. However, it is not difficult
for a patient to lie quietly for 5 minutes, have a short break
whilst they move to the standing position and keep still for
another 5 minutes and then lie down quietly for a final 5 minutes.
As data collection ceases during the moving phase from lying-standing-lying,
any movement artefacts are automatically excluded from the statistical
data analysis. This standardised orthostatic load is used to
stimulate both arms of the autonomic control subsystems, sympathetic
(standing) and parasympathetic (supine), while the reactions
of the body are measured within predefined short-term intervals.
This approach enables full repeatability of examination and
hence comparison of its results with ‘normal’ HRV
patterns as collected over years in various clinical trials
and daily routine.Therefore, if the recommended test protocols
are adhered to, the quality of the data, and hence results,
is inevitably going to be far superior to the uncontrolled conditions
of the Holter monitor test. |
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All material contained
within this website is copyrighted to Advanced Medical
Diagnostic Group Limited.
VariaCardio® and VariaPulse are registered trademarks
of AMDG Ltd. This product is protected by patents owned
by AMDG Ltd.
Manufactured for AMDG by MIE Medical Research Ltd (an
ISO13488 accredited company). AMDG and MIE Research Ltd
reserve the right to amend specifications without notice
in accordance to their policy of continual product improvement. |
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| © 2001-5 Advanced Medical Diagnostics Group Ltd. All Rights Reserved. |
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| AMDG Ltd,
6 Wortley Moor Road, Leeds, LS12 4JF
Tel: +44 (0) 113
279 1010 Fax: +44
(0) 113 231 0820
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