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The ''Leakage current Sentinel'' 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. Operation utilizes a microammeter with an overall sensitivity of 2.5g10 4 V / a. The measured root mean square current values are compared with reference values in order to send signals to complementary metal-oxide-semiconductor gates.
The ''Leakage current Sentinel'' 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. Operation utilizes a microammeter with an overall sensitivity of 2.5g10 4 V / a. The measured root mean square current values are compared with reference values in order to send signals to complementary metal-oxide-semiconductor gates.
The ''Leakage current Sentinel'' 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. Operation utilizes a microammeter with an overall sensitivity of 2.5g10 4 V / a. The measured root mean square current values are compared with reference values in order to send signals to complementary metal-oxide-semiconductor gates.
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 C. F. Dalziel, Advances in Biomedical Engineering, edited by J. H. U. Brown and J. F. Dickinson III 1973, Vol. 3, pp. 223248. 2 J. P. Reilly, in Electrical Injury: a Multidisciplinary Approach to Therapy, Prevention, and Rehabilitation, edited by R. C. Lee, M. Capelli- Schellpfeffer, and K. M. Kelley Annals of the New York Academy of Sciences, New York, 1994, Vol. 720, pp. 2137. 3 L. A. Geddes, IEEE Trans. Biomed. Eng. 20, 465 1973. 4 L. Cromwell, F. J. Weibell, and E. A. Pfeiffer, Biomedical Instrumenta- tion and Measurements Prentice-Hall, Englewood Cliffs, NJ, 1980, Chap. 16, pp. 430447. 5 O. Z. Roy, Med. Biol. Eng. Comput. 18, 657 1980. 6 B. N. Feinberg, Applied Clinical Engineering Prentice-Hall, Englewood Cliffs, NJ, 1986, Chap. 15, pp. 447488. 7 J. E. Bridges, in Electrical Injury: A Multidisciplinary Approach to Therapy, Prevention and Rehabilitation, edited by R. C. Lee, M. Capelli- Schellpfeffer, and K. M. Kelley Annals of the New York Academy of Sciences, New York, 1994, Vol. 720, pp. 246258. 8 W. H. Olson, in Medical InstrumentationApplication and Design, edited by J. G. Webster Wiley, New York, 1995, pp. 751788. 9 J. M. R. Bruner and P. F. Leonard, Electrical Safety and the Patient Year Book Medical Publisher, Chicago, IL, 1989. 10 S. E. McNulty, Anesth. Analg. 78, 587 1994. 11 M. Ezawa, J. Clin. Eng. 15, 29 1990. 12 IEC Publication 601-1, International Electrotechnical Commission, Geneva 1988. 13 ANSI/AAMI ES1, Safe Current Limits for Electromedical Apparatus 1985. 14 NFPA No. 99-1996, Standard for Health Care Facilities National Fire Protection Association, Quincy, MA, 1996, Chaps. 7 and 9. 15 F. P. Branca, Z. Del Prete, and F. Marinozzi, Rev. Sci. Instrum. 64, 3303 1993. 16 Analog Devices AD 637 integrated high accuracy rms to dc converters were utilized. 2866 Rev. Sci. Instrum., Vol. 71, No. 7, July 2000 Cappa, Marinozzi, and Sciuto