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Does Non Medical Grade Power Cord Compromise The Safety of Medical Equipment?
Does Non Medical Grade Power Cord Compromise The Safety of Medical Equipment?
Does Non Medical Grade Power Cord Compromise The Safety of Medical Equipment?
A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth
approximately 41 million USD, while the power cords supplied along with the imported equipment
do not comply with countryspecific norms. Moreover, the local vendors procure power cords with
Access this article online typeD/M plug to complete installation and also onsite electrical safety test is not performed.
Website: www.ijaweb.org Hence, this project was undertaken to evaluate the electrical safety of all lifesaving equipment
purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission
DOI: 10.4103/0019-5049.171556
62353, the Association for the Advancement of Medical Instrumentation(AAMI) and National Fire
Quick response code
Protection Association(NFPA)99 hospital standard for the analysis of protective earth resistance
and chassis leakage current. This study was done with a measuring device namely electrical
safety analyser 612 model from Fluke Biomedical.
Key words: Device under test, electrical safety test, equipment leakage current, protective earth
resistance
and Research, Pondicherry [Table1]. They belonged to Protective earth resistance/earth bond testing
ClassI category with detachable power cords of power Earth bond testing tests the integrity of the low
consumption<1.5 KVA(kilovolt ampere). ClassII resistance connection between the earth conductor
category, nondetachable power cord equipment and and any metal conductive parts, which may become
permanently installed equipment were excluded live in case of a fault on ClassI medical devices.
from the testing. Since all the tested equipment were Although many ClassI medical devices are supplied
newly purchased, the influence of film resistance with an earth reference point, most if not all medical
was excluded.[4] The electrical safety analyser(ESA) devices require multiple earth bond tests to validate
612 model was used which is capable of measuring low the connections of additional accessible metal parts of
resistance up to 2 with an accuracy of2% and leakage the enclosure. The test current is applied between the
current from 0 A to 1999 A with an accuracy of1%. earth pin of the mains supply plug and any accessible
The analyser incorporates test algorithm of Association metal part(including earth reference point) via a
for the Advancement of Medical Instrumentation(AAMI)/ dedicated earth bond test lead(clip/probe). The test
National Fire Protection Association (NFPA)-99 hospital method of ClassI equipment in reference to the 62353,
standard and IEC 62353.[5] All the measurements were IEC 2007(IEC 683/07) guideline is shown in Figure1.
manually obtained for better accuracy.
The MD ESA 612 applies a test current of 200mA
Test method to determine PER and the highest reading will
The standard test protocol involves two components; determine pass or fail criteria.[1] The allowable test
visual inspection and electrical testing.
limits are based on IEC 62353 and AAMI guideline:
100 mfor a detachable power cable up to 3m;
Visual inspection
300 mfor a Class I device including power cable
The equipment in working condition can only be
tested for electrical safety. This method identifies the (not exceeding 3m) and 500 mfor a medical
equipment type, model, power consumption, power system as per AAMI/NFPA99 hospital standard.
cord typeD/M and fuse ratings. In addition, it also An increase in resistance may indicate loosening/
checks site condition inclusive of input power and corroded connection or damaged or nonstandard
electrical socket where equipment is being used. cables, which need to be repaired before continuing
with the leakage test.
Electrical safety test
The electrical safety test involves PER and leakage Deviation
current measurements. The device under test(DUT) Class II equipment and doubleinsulated devices do
will be powered through the measuring device(MD) not have a protective earth. It is, therefore, neither
and testing probe performs the measurement. While necessary nor possible to measure earth continuity;
testing, all other external communication/data lines this poses no safety risk.[1]
such as video graphics array and Ethernet cables
must be removed from the DUT to eliminate parallel
earth.[1]
RESULTS
Table2: Electrical safety test results of selected 20 equipment tested with medical grade power cord and nonmedical
grade power cord
Medical equipment details Protective earth resistance(m) Leakage current in singe fault condition(A)
Name Make/model Nonmedical grade Medical grade Nonmedical grade Medical grade
Monitor GES5 Anaesthesia 332 97 110.00 115.00
Anaesthesia machine GEAestiva 7100 445 152 142.00 139.00
Monitor GES5 Anaesthesia 214 101 111.00 115.00
Anaesthesia machine GEAestiva 7100 356 83 153.00 156.00
Anaesthesia machine GEAestiva 7100 234 90 188.00 176
Diathermy ERBEVIO 300 S 543 84 14.00 23.1
Monitor GES5 Anaesthesia 230 76 111.00 116
Diathermy ERBEVIO 300 D 220 85 126.00 131
Pulse oximeter L and TComet 790 77 304.00 317
Ventilator HamiltonGalileo Gold 905 81 79.30 81.5
Ventilator HamiltonGalileo Gold 1230 83 80.50 78.5
Ventilator HamiltonGalileo Gold 980 82 84.80 83.2
Ventilator HamiltonGalileo Gold 1040 83 83.40 79.8
Ventilator HamiltonGalileo Gold 2000 76 84.80 82.9
Ventilator HamiltonGalileo Gold 1850 79 83.00 82.2
Monitor L and TStar Plus 393 182 201.00 202
Ventilator Care fusionVela 1800 90 175.00 169
ECG machine PhilipsPage writer trim I 1700 392 49.70 45
Defibrillator Nihon KodhenTEC 5521K 610 190 199.00 203
Defibrillator Nihon KodhenTEC 5521K 550 175 380.00 389