The Leakage Current Sentinel: A novel plug-in socket device for online

biomedical equipment electrical safety surveillance

Paolo Cappa
a)
and Franco Marinozzi
Department of Mechanics and Aeronautics, University of Rome La Sapienza, Via Eudossiana 18,
00184 Rome, Italy and Clinical Engineering Service, Childrens Hospital Bambino Gesu` of Rome,
P.zza S. Onofrio 4, 00165 Rome, Italy
Salvatore Andrea Sciuto
b)
Department of Mechanical and Industrial Engineering, University Roma Tre, Via della Vasca Navale
79, 00146 Rome, Italy and Clinical Engineering Service, Childrens Hospital Bambino Gesu` of
Rome, P.zza S. Onofrio 4, 00165 Rome, Italy
Received 8 December 1999; accepted for publication 17 April 2000
The Leakage Current Sentinel LCS has been designed and implemented for the detection of
hazardous situations caused by dangerous earth leakage current values in intensive care units and
operating theaters. The device, designed and manufactured with full compliance of the high risk
environment requirements, is able to monitor online the earth leakage current and detect ground
wire faults. Operation utilizes a microammeter with an overall sensitivity of 2.510
4
V/A. In order
to assure the reliability of the device in providing alarm signals, the simultaneous presence of
absorbed power current is monitored by means of another ammeter with decreased sensitivity 3.0
V/A. The measured root mean square current values are compared with reference values in order
to send signals to NAND and OR complementary metaloxidesemiconductor gates to enable
audible and visible alarms according to the possible hazardous cases examined in the article. The
nal LCS packaging was shaped as a wall socket adapter for common electromedical device power
cord plugs, with particular attention to minimizing its dimensions and to provide analog voltage
outputs for both measured leakage and power currents, in order to allow automatic data acquisition
and computerized hazardous situation management. Finally, a personal computer based automatic
measuring system has been congured to simultaneously monitor several LCSs installed in the same
intensive care unit room and, as a consequence, to distinguish different hazardous scenarios and
provide an adequate alert to the clinical personnel whose nal decision is still required. The test
results conrm the effectiveness and reliability of the LCS in giving an alert in case of leakage
current anomalous values, either in case of a ground fault or in case of a dangerous leakage current.
2000 American Institute of Physics. S0034-67480004107-1
I. INTRODUCTION
The physiological effects of current intensity has been
widely investigated and the threshold of human perception
has been statistically evaluated.
1,2
Further studies have been
conducted to determine the ventricular brillation depen-
dency on the current and duration of the shock for mac-
roshocks i.e., when the current ows through the patients
whole body for different subject weights.
3
The observed
limits drastically lower in case of microshock i.e., when
most of the applied current ows through the heart
47
and
values even less than 20 A can be statistically harmful.
Early in 1969, there were reports that some catheterized
patients were electrocuted by small, imperceptible currents
applied via catheter to the heart.
8
However, the number of
these deaths is difcult to document, because denitive
pathological evidence seldom exists and, only in four cases,
correlation to small current injuries was credibly attributed.
9
More recently, McNulty
10
reports a case where ventricular
tachycardia occurred in a catheterized patient as a direct ef-
fect of the activation of a properly working electrosurgical
unit, despite its active electrode not being in contact with the
patient.
The extremely reduced value of dangerous current in
case of microshock and the unavoidable presence of leakage
currents induced by electromedical equipment power supply
into the patient
11
have been the main reasons for strictly
dening several international electric-safety codes and
standards.
1214
However, in usual practice, the accomplish-
ment to all the mentioned specications prescribed for bio-
medical devices can be veried only during acceptance tests
or preventive maintenance controls, examining only one de-
vice at a time regardless of possible effects due to interaction
of simultaneous working equipment. In fact, depending on
restrictions imposed by current standards, it is difcult to
arrange a measurement system on the ground line a to mea-
sure earth leakage current ELC and, as a consequence, b
to check ground wire integrity without interrupting the
ground wire or altering its impedance. Moreover, as emerges
from the possible shock scenarios,
8
even in an isolated power
system, such as an operating theater OT and/or an intensive
a
Electronic mail: cappa@dma.ing.uniroma1.it
b
Electronic mail: sciuto@uniroma3.it
REVIEW OF SCIENTIFIC INSTRUMENTS VOLUME 71, NUMBER 7 JULY 2000
2862 0034-6748/2000/71(7)/2862/5/$17.00 2000 American Institute of Physics
care unit ICU powered by insulation transformer, hazard-
ous situations occur either in the case of ground-wire failure,
i.e., when the electromedical device ELC totally disappears,
or when ELC rises over the limit of 500 A,
12
e.g., in the
case of poor electrical insulation of the device. These are the
main reasons why a simple ground fault detection is not
sufcient and, therefore, ELC value online monitoring be-
comes necessary.
In order to fulll the mentioned constraints, in a previous
study, a transducer capable of measuring current values from
0 to 500 A
rms
with a resolution of about 10 nA was pro-
posed and metrologically characterized.
15
Despite the ob-
tained satisfactory results, the designed device was still a
prototype and, therefore, its usability was denitely unprac-
tical in a high risk environment, such as OTs and/or ICUs,
where the transducer was intended for use. Therefore, the
aim of the present work is the design, realization, and eld
validation of a device that will be addressed as Leakage Cur-
rent Sentinel LCS, capable of a online monitoring ELC
rms
value and b detecting a ground wire fault with full respect
of OT and ICU constraints.
II. INSTRUMENT DESCRIPTION
The application of a device for online monitoring ELC
and ground fault detecting in high risk environments, such as
OTs or ICUs, is subject to the strict limitations due to critical
working conditions. Because of electromagnetic interference
induced by electromedical equipment functioning in particu-
lar electrosurgical units, it is necessary to implement a eld
version of the previous microcurrent sensor
15
originally con-
ceived for laboratory tests. The eld version is capable of
providing reliable warning signals without altering, in any
way, the electrical system of both the hospital and the bio-
medical equipment. Finally, installation and use of the de-
vice should not interfere with medical personnel activities.
In order to allow reliable eld operation, i.e., correct
functioning in an electrical noisy environment, an overall
current sensor signal to noise ratio improvement was neces-
sary while an adequate impedance matching between the
sensor and the preamplier remained unchanged. To this
aim, the original conguration was mirrored upstream with a
differential stage according to the scheme represented in Fig.
1. With reference to this gure, the sensitivity provided by
the modied conditioning electronics is doubled, while the
overall noise voltage, dened as the statistical sum of rst
stage output noises, is only increased by a factor of 2 so
that the signal-to-noise ratio SNR is 2 times greater. With
regard to the other metrological performances of the measur-
ing system, no appreciable changes have been observed. The
overall sensitivity of the ELC measuring system is 2.5
10
4
V/A.
Furthermore, as the early microammeter prototype was a
simple current sensor with 10 nA resolution and a noise oor
lower than 200 nA, it can be adopted as a ground fault de-
tector when it measures ELC
rms
values lower than 400 nA,
which corresponds to the rounded up minimum detectable
signal, dened as two times the noise oor intensity. This
issue is in accordance with: a International Electrotechnical
Commission IEC Publication 601-1,
12
which limits the
leakage current for heart-surgery equipment to less than 500
A measured with 1 A resolution, and b common expe-
rience, which conrms that even battery powered heart-
surgery equipment, such as infusion pumps, presents ELC
rms
values always higher than 400 nA. Thus, as summarized in
Table I: a ELC
rms
values less than 0.4 A are representa-
tive of ground fault type A alarm; b ELC
rms
value lies in
the range from 0.4500 A during safe and common opera-
tion; and, nally, c ELC
rms
values higher than 500 A
must be considered harmful type B alarm. Obviously, an
ELC absence also occurs when no devices are plugged in
and a consequent false warning appears. So, as the device
must detect a ground fault only when an electromedical de-
vice is plugged in and functioning, it was decided to enable
type A and B alarm signals only in the simultaneous pres-
ence of a ELC
rms
and power line current absorption higher
than 10 mA. To this aim, as represented in Fig. 1, a second-
ary circuit based on a highly reduced sensitivity 3.0 V/A
current sensor is introduced to measure the current owing to
power the electromedical device and the corresponding root
mean square rms signal, together with the microammeter
output, are sent to the logic circuit depicted in Fig. 2.
TABLE I. Analysis of potentially harmful situations for equipment being
protected when equipment is on or off. Type A, ground fault; type B, harm-
ful device functioning; type C, leakage current from another device.
Status of Earth leakage Hazardous
device current (A
rms
) situation
On 0.4 Yes
type A
On 0.4500 No
On 500 Yes
type B
Off 10 Yes
type C
Off 10 No
FIG. 1. Schematic of the LCS analog circuit: A1, A2, A4, leakage current
ampliers; A3, power current amplier; R1, R2, rms to dc converters; V
L
,
measured earth leakage current analog voltage output (2.510
4
V/A; V
P
,
measured power current analog voltage output 3.0 V/A; C
L1
, C
L2
, C
L3
,
leakage current comparators; C
P
, power current comparator; V
Lref1
, V
Lref2
,
V
Lref3
, comparators leakage threshold voltages; V
Pref
, comparators power
threshold; and , earth leakage current and power logic signals.
2863 Rev. Sci. Instrum., Vol. 71, No. 7, July 2000 Electrical safety surveillance
Furthermore, a third type of hazardous situation type C
alarm must be taken into account: In fact, even though an
electromedical device is plugged in and switched off, some
ELC may ow, injected by other operating devices. There-
fore, as: a when a device is not powered, there is no reason
nor experimental evidence for ELC
rms
values higher than 1
A; b IEC Publication 601-1 states that the limit for leak-
age current in parts applied to a patient must be lower than
10 A; c ELC
rms
values higher than 10 A are widely
accepted as harmful for a catheterized patient,
48
it was as-
sumed that when the device is not powered and a current
higher than 10 A occurs, it can only come from other ap-
plied parts by owing through the patient and, therefore, a
catheterized patient can be in a dangerous situation which
must be considered harmful. However, the mentioned case is
highly improbable because a device with applied parts
should not be turned off.
With reference to Fig. 1, measured ELC and power cur-
rent signals are conditioned by two rms to dc converters
16
to
provide continuous voltages to be compared by means of
C
L1
, C
L2
, C
L3
, and C
P
, to reference values according to
Table I. Reference voltages V
Lref1
, V
Lref2
, and V
Lref3
corre-
spond respectively to 500, 0.4, and 10 A
rms
ELC, while
V
Pref
, as already indicated, is referred to 10 mA power cur-
rent.
A simple logic circuit, showen in Fig. 2, was nally
implemented using NAND and OR complementary metal
oxidesemiconducotr CMOS gates to enable audible and
visible alarms according to the cases indicated in Table I.
In order to allow practical usability, the LCS was ar-
ranged in a 905040 mm
3
package similar to those com-
monly utilized for ofine electrical safety tests, see Fig. 3.
The realized device, which appears as a wall socket adapter
for common electromedical device power cord plugs, i.e., a
standard Shuko adapter S and P, presents: a a visible
AL and audible
have been carried out on commonly used intensive care elec-
tromedical devices in order to recognize the reliability of the
proposed device in recognizing hazardous situations. All the
recorded current trends were similar. Figure 5 shows the
characteristic behavior of leakage and power current mea-
sured by LCS during one of the tests carried out on a multi-
parameter cardiomonitor. In this graph it is possible to rec-
ognize different occurrences. Before instant B, the LCS
measures low current absorption and ELC
rms
higher than 400
nA and no alarm signal is shown; after B, an ELC value of
about 0.9 A in correspondence of about 0.6 A absorbed
current indicates that the monitor is correctly operating and,
as expected, the alarm remains silent. Each peak shown in
this gure corresponds to extracurrents: These short term
phenomena are the main reason for introducing a lter into
the alarm activation circuit. As expected, a noticeable
ELC
rms
value decrease below the threshold value of 400 nA
appears when the ground fault takes place at instant C: this
occurrence is detected by the LCS which provides an alarm.
Furthermore, the ELC
rms
observed value obviously does not
change with absorbed power variations when the earth wire
is intentionally interrupted and the alarm remains activated.
Only an ELC spike appears at instant E when the electro-
medical device is turned on again but, because of the lter,
the warning signal still remains on.
A further test was performed in order to verify the pos-
sibility of using a single LCS device for simultaneously
monitoring several electromedical devices, such as all of the
equipment operating in the same high risk electrical environ-
ment, i.e., supplied by the same isolation transformer. To this
aim, a pulmonary ventilator and an infusion syringe pump
have been connected to the same LCS and in Fig. 6 the trend
of ELC
rms
value is reported for different situations. With
reference to Fig. 6, at instant A it is possible to observe the
simultaneous ELC
rms
and adsorbed current increase when the
pulmonary ventilator is plugged in and turned on and the
alarm remains silent. An anomalous phenomenon occurs at
instant B, when the infusion pump is also connected and
switched on: the ELC
rms
value drastically decreases below
400 nA in correspondence to a power current absorption in-
crease and the LCS sends an erroneous warning signal last-
ing for the time length from B to C. This event can be ex-
plained considering that, during concomitant activation of
both the cited devices, the ELC decrease occurs depending
on the phase relationship between the ELCs of each appara-
tus; in fact, the value resulting from the sum of these cur-
FIG. 5. Earth leakage current
rms
value as a function of
different situations for a single operating device: A
the device is plugged in but still switched off; B the
device is switched on; C the earth ground wire is in-
tentionally interrupted; D the device is switched off;
E the apparatus is switched on again while the ground
wire still remains interrupted and, nally, F the moni-
tor is switched off.
FIG. 6. Earth leakage current
rms
value as a function of
different situations for two operating devices: A a pul-
monary ventilator is plugged in and turned on; B an
infusion pump is plugged and turned on; C the venti-
lator is turned off; D the infusion pump is nally un-
plugged.
2865 Rev. Sci. Instrum., Vol. 71, No. 7, July 2000 Electrical safety surveillance
rents, owing through the same monitored conductor, de-
pends on their own modulus and phase. In particular, the
ELC
rms
value, with respect to the noise oor, in the time
period from B to C approaches the difference between the
pump and pulmonary ventilator ELCs
rms
. Finally, when the
ventilator is turned off the LCS stops the alarm. The ob-
served behavior forced the use of one ELC for each plug and,
consequently, for each of the installed electromedical de-
vices.
Finally, in order to keep the electrical safety of high risk
environments under control, a PC based measuring system
capable of acquiring and processing the output analog ELC
and power current signals of the LCS was designed and re-
alized. In a rst eld verication, the automatic system was
implemented on a single ceiling pendant two-bed system
equipped with six LCSs. After preliminary tests devoted to
the verication of LCSs functionality, each bed was provided
with a ventilator, an infusion pump, and a multiparameter
monitor in order to carry on a one week trial at the ICU of
the Childrens Hospital Bambino Gesu
`
of Rome. During
this experiment, the alarms had been disconnected so as not
to interfere with clinical activities and the electrical LCS
outputs had been monitored and recorded. Despite the regis-
tering of the current trends and their behavior being in ac-
cordance with the previous test conducted with a single LCS,
fortunately no hazardous occurrences were observed. After
this trial period, the proposed system proved its capability, of
automatically managing potentially hazardous situations,
even for several simultaneous operating LCS or different
rooms such as all of the operating theaters of a surgical ward,
by providing an alert to physicians whose last decision for
intervention is still required.
1
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12
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13
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14
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16
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2866 Rev. Sci. Instrum., Vol. 71, No. 7, July 2000 Cappa, Marinozzi, and Sciuto