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Calibration of Defibrillator Analyzer by Voltage Square Method

Conference Paper · October 2018

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 Calibration of Defibrillator Analyzer by Voltage Square
Method

Fabrício Gonçalves Torres1, Felipe Santiago Apolinário1, Regis Renato Dias1 and
Tiago Lopes Santos1
1
Instituto de Pesquisas Tecnológicas do Estado de São Paulo - IPT, Brazil
fabrigt@ipt.br

Abstract. Defibrillator is an electromedical equipment used to rescue patients

with cardiac arrhythmias. The success rate in the use of the equipment is high,
however, it is necessary that the defibrillator is in good condition and, therefore,
must be tested by means of a defibrillator analyzer. There is a need for the de-
fibrillator analyzers to be calibrated and their measurements have metrological
traceability. The measurements carried out by the analyzers must not exceed the
tolerances determined by the medical standards and therefore the equipment
used in the calibration of these devices must have an uncertainty lower than the
required tolerances. The present work has the purpose of presenting a calibra-
tion method of defibrillator analyzer by means of the integration of voltage
square level, which has an uncertainty lower than the tolerance required by the
standards of electromedical. The uncertainty components that are relevant for
calibration are described. The proposed method was tested in the calibration of
a defibrillator analyzer and the results obtained from the calibration are present-
ed.

Keywords: Analyzer defibrillator, Calibration, Metrology.

1 Introduction

Defibrillator is an electromedical equipment that has the purpose of reverting cardiac

arrhythmias of patients, through the application of electric energy on the patient's
chest, being able to reach levels up to 360 J. The practice of defibrillation is highly
recommended in emergency situations, as in cases of ventricular fibrillation, because
a great chance of saving the patient's life is obtained, especially if used early [1].
The first experiments with defibrillation began in 1899 and until the 1960s, alter-
nating current signals (60 Hz) were used. Subsequently, studies showed better results
in defibrillation by means of direct current. Presently, two types of defibrillators are
more common: monophasic and biphasic, the latter, more recently developed, repre-
sents greater patient safety and efficiency [1].
Monophasic defibrillation is a technique which involved charging of a bank of ca-
pacitors to the energy desired then delivering the charge through an inductance such
as to produce a heavily damped sinusoidal wave of short duration, approximately 5
milliseconds, to the heart by way of paddle electrodes, having a mainly uniphasic
2

characteristic. On the other hand, biphasic defibrillation alternates the direction of the
pulses, completing one cycle in approximately 12 milliseconds.

Fig. 1. Biphasic waveform (A) and monophasic waveform (B)

Like any electronic equipment, a defibrillator can cause failures over time, includ-
ing applying energy levels with errors greater than the tolerances determined by the
standards, such as ABNT NBR IEC 60601 (2016). Therefore, these devices must be
tested regularly by means of a defibrillator analyzer. In turn, a defibrillator analyzer
must be calibrated periodically, by means of standards that can guarantee the chain of
metrological traceability of the measurements.
According to [2], to comply with the standards ABNT NBR IEC 60601-2-4: 2005
and ANSI / AAMI DF80: 2003 the energy measurement of a defibrillator analyzer
must have a tolerance of ± 5 % of the measured energy or ± 1 J, whichever is greater,
and therefore it is recommended that the measuring system used to perform the cali-
bration has lower uncertainties than the recommended tolerances.
In the literature, several calibration methodologies for defibrillator analyzers can
be found. In [3], it is recommended that the calibration of the analyzer be performed
on each block of the equipment separately: internal attenuator, filter and A/D convert-
er block. However, in order to perform it, it is necessary to open the equipment and
identify its main parts. This practice becomes difficult to perform by calibration la-
boratories since there is a need to have information about equipment that is not nor-
mally available by manufacturers. Another relevant issue is about the fact of the cali-
bration being performed under different circumstances of the use of the item under
calibration may present risks in the reliability of the results obtained. Finally, we don't
recommend opening physically any instrument to calibrate it.
In [4], there are at least two ways of calibrating the energy range of a defibrillator
analyzer: by simultaneously measuring the current and voltage applied by a defibrilla-
tor, or by measuring the resistance of the load and the voltage applied. The second
case was the method adopted in this work. According to [4], the difference between
the two methods is of the order of 0.05 %, a negligible value as compared with the
other uncertainty components of the calibration set.
 3

2 Description of the Calibration Set

The method adopted for this work consisted in measuring the resistance of the de-
fibrillator analyzer by means of a high accuracy resistance meter and in the plot of the
voltage curve as a function of time by means of a high voltage probe coupled to a
digital oscilloscope. A commercial defibrillator of the monopolar type was used as a
transfer device.
From the plotted curve, the square voltage values were integrated, according to
equation 1.
  ∆

 
=  
 = ∑   ×    (1)

Where,
Vt = peak voltage measured by the probe coupled to an oscilloscope
R = resistance of the defibrillator analyzer
Ti and TF = initial and final time of the plotted curve (record lenght)
∆T = quantization interval of the plotted curve

For calibration of the analyzer, the energy points of 12 J, 25 J, 90 J, 180 J, 275 J

and 345 J were adopted.
For the quantization of the waveform, the oscilloscope function was used to meas-
ure the area. It was also developed, through LabVIEW℗, a system that allowed pre-
senting the results directly in Joule (figure 2). These results were considered as Refer-
ence Values, and were used to compare with the values indicated by the defibrillator
analyzer under calibration.
It was also necessary to characterize the high voltage probe and the oscilloscope
set by means of low uncertainty standards to obtain a calibration system with suffi-
cient uncertainty for the calibration of the defibrillator analyzer. The characterization
consisted basically in the determination of the nonlinearity of the high voltage probe
and in the determination of the systematic and random error of the probe oscilloscope
set.
4

Fig. 2. Software developed for energy measurement

2.1 Determination of the high voltage probe nonlinearity

This method consists of the calibration of the Tektronix P6015A probe, whose output
impedance is 1 MΩ, coupled to the National Instruments High Speed Digitizer PXI-
5124 board, using the standard Fluke 5700A calibrator, thus determinating the uncer-
tainty of the set.
To ensure the conditions of use of the equipment involved, the warm-up was met
and the standards were self-adjusted, according to the manufacturers' recommenda-
tions.
For a complete analysis of the linearity of the set, DC voltage values (500 V,
1000 V, 3000 V and 5000 V; negative and positive) and AC voltage (500 V, 1000 V,
3000 V and 5000 V; with 60 Hz) were applied at the input of the high voltage probe.
To acquire the signal, the data acquisition software LabVIEW℗was used.
After the acquisition of 4 readings of each value applied, the results were analyzed
and the uncertainty due to the non-linearity of the set probe plus high speed digitizer
was determined.

2.2 Characterization of the probe and oscilloscope set

Characterization of the probe and oscilloscope set is performed by means of Fluke
5700A multifunction calibrator, applying a 1000 V AC sinusoidal waveform with
frequency 60 Hz. Measurements are performed before and after calibration of the
defibrillator analyzer, in order to detect any variation of the set during the calibration.
 5

The systematic and random error values obtained in the characterization was as-
signed as components of uncertainty and included in the final calibration uncertainty
of the defibrillator analyzer.

3 Estimation of Uncertainty

The table 1 summarizes the distribution assignments made for each input quantity of
the measurement model.

Table 1. Components of energy measurement uncertainty

Quantity Probability Distribution Function

Uncertainty due to variability Gaussian
Resolution of the defibrillator analyzer Rectangular
Uncertainty due to load resistance Gaussian
Uncertainty due to probe and oscilloscope set Gaussian
for time interval
Uncertainty due to probe and oscilloscope set Gaussian
for voltage measurement
Resolution of the probe and oscilloscope set Rectangular
Voltage probe nonlinearity Rectangular

From equation 1, in relative values, the combined standard uncertainty is calculat-

ed according to equation 2.
!        
   "  " #$ $ #% %
  =  (2)

Where,
uE = combined standard uncertainty of the energy measurement
uT = standard uncertainty due to probe and oscilloscope set for time interval
uR = standard uncertainty due to load resistance
uV = standard uncertainty due to probe nonlinearity and probe and oscilloscope set
for measuring voltage

The uR uncertainty was obtained by measuring the internal resistance of the defib-
rillator analyzer under calibration using a digital multimeter. The uncertainty compo-
nents taken into consideration for the uR calculation were: uncertainty and resolution
of the standard multimeter and variability from four resistance readings.
For the uT uncertainty, the component was considered due to time base of the oscil-
loscope on the sampling rate of the oscilloscope (1 MS/s) resulting in the time interval
of 1 µs.
The uncertainty uV was calculated by means of the following uncertainty compo-
nents: nonlinearity (described in item 2.1) and characterization of the probe and oscil-
loscope set (described in item 2.2).
6

The expanded uncertainty was obtained by multiplying the combined standard un-
certainty with the coverage factor to a confidence level of approximately 95 %.

4 Results

The results of the calibration of the defibrillator analyzer are shown in figure 3. For
each point of the graph, there was its respective expanded uncertainty of the meas-
urement represented by means of the vertical bars. The dotted lines of red color repre-
sent the tolerance of ± 5 % of the measured energy or ± 1 J, whichever was greater,
complied with the standards ABNT NBR IEC 60601-2-4: 2005 and ANSI / AAMI
DF80: 2003.

Fig. 3. Results of the defibrillator analyzer calibration

Table 2 contains the most detailed information on calibrated points. For each point,
the following information was reported: measurement error, expanded uncertainty
(U), coverage factor (k) and degrees of freedom (νeff).

Table 2. Detailed Defibrillator Analyzer Calibration Values

Value (J) Error (%) U (%) k νeff

12 1,29 0,53 2,00 ∞
25 0,96 0,52 2,25 12
90 1,14 0,42 2,25 11
180 0,84 0,21 2,01 209
275 0,60 0,20 2,01 189
345 0,55 0,32 2,28 11
 7

According to table 2, it was verified that the expanded uncertainty of the measure-
ment was proportionally higher for the smaller values. This feature was due to the
resolution of the defibrillator analyzer under calibration, which ends up contributing
significantly to the low energy values. For the higher values, the uncertainty of the
standards set is the most significant portion for the expanded uncertainty.

5 Conclusion

This work presented a method of calibration of the energy range of defibrillator ana-
lyzers that could be feasible its application to calibration laboratories, and that al-
lowed obtaining, in its results, low enough uncertainties to meet the determinations of
electromedical standards.
According to the results presented in this work, it can be verified that the proposed
calibration method was adequate, since the uncertainty obtained resulted in a value 10
times lower than the tolerance for this equipment. Although it is not the scope of the
work, it can also be verified that the method can be used to calibrate any type of
waveform (monophasic or biphasic, for example), since the developed system is ver-
satile enough to perform the measurement of the energy for any waveform.
Perhaps the only disadvantage of the proposed calibration method could be the
need to use a defibrillator as the transfer device. However, it is verified that it is the
most reliable means to carry out the calibration, since it uses a signal with the same
characteristics whose defibrillator analyzer must be able to measure with the best
accuracy. Calibrating the equipment by applying another type of waveform may mask
some type of error that is detectable only with the waveform of a defibrillator.

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