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1 대한응급의학회지제 27 권제 3 호 Volume 27, Number 3, June, 2016 Resuscitation 전자기장간섭이자동제세동기에미치는영향 : 실험연구및문헌고찰 원 저 구재은 1 유제성 2 주영선 2 공태영 2 고동률 2 정성필 2 안양샘병원응급의학과 1, 연세대학교의과대학응급의학교실 2 Effect of Electromagnetic Interference on Automated External Defibrillator: Simulation Study with Literature Review Jae Eun Ku, M.D. 1, Je Sung You, M.D. 2, Young Seon Joo, M.D. 2, Taeyoung Kong, M.D. 2, Dong Ryul Ko, M.D. 2, Sung Phil Chung, M.D. 2 * Purpose: Automated external defibrillators (AEDs) could not recommend shock for ventricular fibrillation in the presence of electromagnetic interference. The purpose of this study was to examine the effect of an induced electromagnetic field on performance of AED. Methods: The intensity of magnetic waves from commercial electric mats was measured. Three AEDs were attached to the resuscitation manikin and the question of whether shock would be recommended for simulated electrocardiogram of VF or normal sinus rhythm was tested. The simulation was repeated 10 times under the influence of 0, 5, and 18 μt magnetic field or electric mat. Relevant literature studies on electromagnetic interference on AED were reviewed. Results: The magnetic flux density from the electric mat was measured to μt in warming phase, and μt in maintenance phase. There was no false positive or false negative recommendation of shock under the influence of 0, 5, and 18 μt magnetic field or electric mat. However, one AED detected motion even in the stationary state. Among 11 studies from the literature search, five studies reported misinterpretation of AED. Minor errors including delayed analysis, motion artefact, and noise in speakers were reported from 6 studies. Conclusion: Although we could not reproduce false negative interpretation, AED made a mistake in confusing electromagnetic interference with motion artefact. Therefore, emergency providers should be cautious not to use AED close to household appliances or medical equipment inducing electromagnetic interference. Key Words: Defibrillators, Electromagnetic fields, Review Department of Emergency Medicine, Anyang Sam Hospital, Gyeonggido 1, Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 2, Korea Article Summary What is already known in the previous study An automated external defibrillator did not recommend shock for ventricular fibrillation in the presence of electromagnetic interference from a commercial electric mattress. What is new in the current study We could not reproduce false negative interpretation in this experiment. However, AED made a mistake in confusing electromagnetic interference with motion artefact. We found various literature studies reporting electromagnetic interferences from a power plant, mobile phone, and medical device in the literature review. 서 론 책임저자 : 정성필서울특별시강남구언주로 211 강남세브란스병원응급의학과 Tel: 02) , Fax: 02) emstar@yuhs.ac 접수일 : 2016년 1월 12일, 1차교정일 : 2016년 1월 24일게재승인일 : 2016년 4월 6일 전자기장 (electromagnetic filed) 이라고도불리는전자파는광범위한형태의전자기에너지를말한다. 파장과주파수에따라다양하게분류되는데, 고압전선이나가전제품에서발생하는저주파수전자기장과휴대폰이나블루투스등에서발생되는무선주파수 (radiofrequency) 전자기장으로나눌수있다. 전자기기의보급과의료장비의무선화 231
2 232 / 대한응급의학회지 : 제 27 권제 3 호 2016 로의료환경도전자파에노출될가능성이많아졌다. 식품의약품안전처에서는 의료기기의전자파안전에관한공통기준규격 을제정하여전자파장해 (interference) 와전자파내성 (susceptibility) 에대한표준시험규격을제시하고있다. 자동제세동기 (automated external defibrillator, AED) 는급성심장정지가의심되는환자의심전도를자동으로판독하여자동으로제세동을시행또는권고하는장비로판독오류가환자의생존에영향을미칠수있다. AED 또한의료장비로서적정기준의전자파적합성을통과하여야한다. 하지만 Ku 등 1) 은국내시판중인AED를대상으로전기장판에서발생하는전자파가심실빈맥이나심실세동을제세동이필요하지않다고판독하는경우가있음을보고하였다. 저자들은전기장판에서발생하는전자파가 AED에미치는영향을연구하기위해서실험실환경에서전원주파수로사용되는 60 Hz의자기장을생성하여전자파의세기에따라 AED 판독의정확도를알아보고자이번연구를계획하였다. 또한문헌고찰을통하여전자기간섭이 AED에미치는영향을조사하고자하였다. 대상과방법 1. 실험연구국내에서사용되는 AED 중에서실험일정에맞추어제품대여가가능했던 Lifepak CR Plus (Medtronic, Mineapolis, MN, USA), CardioLife TEC 5521 K (Nihon Kohden, Tokyo, Japan), Heart On AED A10 (Mediana, Wonju, Korea) 의 3가지제품을실험에사용하였다. Heart On AED A10은완전자동이었고, 나머지는반자동이었다. 본실험에서사용한각 AED는제품명대신 ABC로표시하였다. 인체모형은 Resusci Anne CPR-D (Laerdal Medical) 을사용했으며, AED에제세동패드를부착한다음 MicroHeartSim (Laerdal Medical, Norway) 를이용하여심실세동과정상굴리듬 (normal sinus rhythm, NSR) 을발생시켰다. AED 별로 2가지리듬을각각 10회씩발생시키고, 제세동을권고하는지조사하였다. 심실세동이지만제세동을권고하지않는경우를위음성으로정의하였고, 정상굴리듬이지만제세동을권고하는경우를위양성으로정의하였다 2). 위양성과위음성의경우를오작동으로정의하였다. 한편 AED가정지상태임에도불구하고환자의움직임을감지하거나밀착된패드의접촉을확인하라는지시가나오는등의경우를오류로정의하였다. 전기장판에서발생하는전자파의세기를측정하기위해 ELT-400 (Narda STS, Hauppauge, NY, USA) 를이용하여자기장을측정하였다. 전기장판은리젠트 (Reagent electric mattress, Daegu, Korea), 니프티 (Nifty electric mattress, Kyungsan, Korea) 두제품을사용하였다. 두가지전기장판의전원을켜지않았을때와전원을켜고최고가온상태에서전기장판을 6등분하여각부위와온도조절기부위의자기장을측정하였다. 각부위를 3회씩측정하여평균값을구하였다. 전기장판위에서 3종류 AED 를 Anne에부착후두가지리듬을발생시켜오작동여부를실험했다. 대조군으로테이블위에 AED를 Anne에부착하여오작동여부를실험하였다. 자기장의영향에따른 AED의정확도를보기위해 MC 2630 (EMTEST, Banovska, Zilina, Slovakia) 를이용하여자기장을발생시켰다. 5 μt 와 18 μt 의자기장을유도하고 AED를 Anne에부착하여오작동여부를실험했다. 각각의동일한실험을 10회반복하였다. 2. 문헌고찰 연구질문은 심정지환자에게 AED를사용할때전자기간섭이있는경우그렇지않은경우에비해생존이나순환회복, 판독의정확도를감소시키는가? 이다. 문헌의선정기준은 1966년부터 2015년까지출판된초록을제외한문헌중에서인간또는마네킨을대상으로하고방법에 AED 가포함되어있으며전자기간섭의영향을결과로제시하고있는문헌을포함하였다. 문헌검색은두명의연구자가 2015년 6월에 PubMed, Embase, Cochrane library, KoreaMed 등의 database를검색하였다. 참고로 PubMed에대한검색식은다음과같다 : ((defibrillators [Mesh] OR automatic external defibrillator$ [TIAB] OR automated external defibrillator$ [TIAB] OR AED* [TIAB] OR defibrillator* [TIAB]) AND (EMI OR electromagnetic [tiab] OR magnetic [tiab] OR interference [tiab])) NOT (implant* [tiab] OR icd [tiab] OR magnetic resonance [tiab] OR epilepsy [tiab] OR aedes [tiab]). Fig. 1. The density of magnetic field on commercial electric mats (Upper: A mat, Lower: B mat, Unit: μt).
3 구재은외 : 전자기장간섭이자동제세동기에미치는영향 : 실험연구및문헌고찰 / 233 PubMed 검색에서 85편, Embase 160편, Cochrane library 11편, KoreaMed 3편이검색되었으며, EndNote ( 7.0.2, Thomson Reuters) 에정리하여중복된문헌을제거하여 138편을얻었다. 제목및초록을보고필요한경우본문을확인하여다음과같은경우에해당하는문헌은제외하였다 : 1) 체내이식형제세동기를다룬경우, 2) 전자파간섭이외의다른영역의안전을다룬경우, 3) 알고리듬개발등전기공학적내용을다룬경우, 4) 영어, 한국어이외의언어로출판된경우. 제외기준에해당하는문헌을제외하고최종선정된문헌은 11편이었는데, 이를검토하여주요결과를요약정리하였다 (Fig. 2). 결과 1. 실험연구전기장판의전원을켜지않은경우측정되는자기장은 0.06 μt 였다. 전원을켠다음전원 controller 부위에서는 1.26 μt, 온도를최대로높여가온상태일때전기장판위의자기장의세기는최대 μt 였다. 최대온도를유지하는상태에서평균자기장의세기는 2.25~2.84 μt 로부위별자기장세기는 Fig. 1과같았다. 전자파간섭이없는상태에서 AED는모두잘작동되었 Fig. 2. Flow diagram of search strategy. Table 1. The proportion of shock recommendation by AED in various interferences AED Simulated ECG Induced magnetic field (N=10) 0 μt 5 μt 18 μt Electric mat A B C VF NSR VF NSR VF NSR * AED detected motion despite still state during each simulated rhythm in 4/ % 100% 100% 100%* (10/10) (10/10) (10/10) (10/10) 0% 0% 0% 0% (0/10) (0/10) (0/10) (0/10) 100% 100% 100% 100%* (10/10) (10/10) (10/10) (10/10) 0% 0% 0% 0% (0/10) (0/10) (0/10) (0/10) 100% 100% 100% 100%* (10/10) (10/10) (10/10) (10/10) 0% 0% 0% 0%* (0/10) (0/10) (0/10) (0/10)
4 234 / 대한응급의학회지 : 제 27 권제 3 호 2016 Table 2. Summary of published studies about electromagnetic interferences on AED Author/year No. of AED/models Sample size Setting Interference setting Result Karczmarewicz 11) N=4/Fore Runner NR Mobile 900 MHz GSM No wrong decision; 2001 Heartstart 3000 phone delay interpretation, Cardio-Aid 100 speaker dysfunction Heartstream XLT Stolzenberg 4) N=3/ PC Life Pak 300 NR Power 400, 600, 1500 mg No wrong decision 2002 SurVivaLing First SAVE AED plant (only magnetic field) Zoll 1600 Defibrillator Kanz 9) N=12/Bruker Defigard ,640 Mobile 900 MHz GSM, No wrong decision; 2004 Corpuls 08/16 phone 3 different position voice distortion Dräger Cardiolog 2000 S Heartstream Forerunner HP Codemaster 100 PC FirstMedic 710 PC LifePak 300 PC LifePak 500 Laerdal Heartstart 911 Laerdal Heartstart QR 3000 Survival Link FirstSave Zoll 1600 Kanz 7) N=11/Corpuls 08/16 5,280 Station Train (15 kv AC) Wrong decision; 2004 Dräger Cardiolog 2000 S Subway (750V DC) accuracy 15 kv 86% Heartstream Forerunner vs 750 V 99%; HP Codemaster 100 Parallel 92.4% vs Laerdal Heartstart 911 perpendicular 97.5% Laerdal Heartstart QR 3000 PC FirstMedic 510 PC LifePak 300 PC LifePak 500 SurvivaLink FirstSave Zoll 1600 Schlimp 14) N=2/LIFEPAK 12 NR Power line 110 kv, 15 kv 16.7 Hz Wrong decision; 2004 FRED more interference in human > manikin, 45 >90, single use pad > multiuse Trigano 10) N=3/LifePak Mobile 900 MHz GSM, No wrong decision; 2006* Lifepak 20 P phone 1800 MHz PCS noise preventable HeartStart XL M4735A phone >15 cm Fleischhackl 6) N=5/AccessAED 760 Power line, electric vs magnetic, False positive 2006* CR+ generator 0 vs 90, 2.4% (18/760); Fred Easy 50 vs 16.7 Hz motion detected HS1 3.6% (27/760) Responder Fleischhackl 5) N=5/AccessAED 390 Station 15 kv AC 16.7 Hz, No false positive 2006* CR+ 750 V DC (0/390); motion Fred Easy detected (2/390) HS1 Responder (continue)
5 구재은외 : 전자기장간섭이자동제세동기에미치는영향 : 실험연구및문헌고찰 / 235 Table 2. Summary of published studies about electromagnetic interferences on AED Author/year No. of AED/models Sample size Setting Interference setting Result Chalkias 12) N=1/Zoll AED plus 1,900 Subway Empty, incoming train, Wrong decision; 2013 with cell phone empty station < incoming train < with cell phone Ku 1) N=4/Lifepak CRplus 320 Home Electrical mattress Sensitivity 55-90%; 2013 PowerHeart G3+ automatic appliance accuracy % Cardiolife TEC 5521 K motion detected Hearton AED A10 Lee 13) N=1/Philips HeartStart MRx NR Hospital Portable suction device AED failure observed; V/m measured, >1 m preventable AED: automated external defibrillator, NR: not reported, GSM: global system for mobile communication, PC: physio-control, AC: alternating current, DC: direct current, PCS: personal communication system * Clinical study. 다. 5 μt 와 18 μt 를유도한상태에서 AED의위양성, 위음성및오류등의오작동은관찰되지않았다. 그러나전기장판위에 AED를두고실험을시행한경우위양성및위음성은없었으나, 한개의 AED에서정지상태임에도불구하고움직임이감지되는것으로방송하는오류가심실세동과정상굴리듬각각 40% 에서관찰되었다 (Table 1). 2. 문헌고찰 AED와관련하여전자기간섭의유무에따라생존이나순환회복여부를비교한연구는없었다. AED에대한전자기간섭을다룬문헌은인체대상연구 3편과인체모형을이용한연구 8편이검색되었다 (Table 2). 연구에따라 1-12개종류의 AED가이용되었다. 전자파의발생원인으로는고압전선근처 3편, 기차역 3편, 휴대폰 3편, 의료기기 ( 이동식흡인기 ) 1편, 가전기기 ( 전기장판 ) 1편이었다. 5편의연구에서 AED의오작동이관찰되었으며판독의지연, 움직임의감지, 스피커의잡음등판독과는무관한오류가 6편의연구에서보고되었다. 고찰저자들은전기장판이 AED의판독에영향을준다고보고한이전연구를바탕으로실험실환경에서전기장판에서발생하는전자파를측정하였다 1). 전자파는전기장 ( 단위 V/m) 과자기장 ( 단위 μt 또는 mg) 으로구성되나일반적으로전기장판과같은가전제품에서발생되는전자파는자기장이주성분이고전기장의영향은고압전선근처가아닌경우영향이거의없으므로저자들은자기장만을측정하였 다. 전기장판의전원을켜고장판이가열상태일때 μt, 최고온도가유지되는상태에서 μt 정도로측정되었다. 이는기존의보고와유사한것인데, Kim 등 3) 은전기장판에서나오는전자파가평균 5.24 μt 라고보고하였다. 저자들은전기장판에서나오는정도의자기장을실험실환경에서유발하였을때유사한영향을미치는지를확인하고자하였다. 하지만전기장판에서일반적으로발생되는자기장의수준인 5 μt 뿐아니라 18 μt 의자기장을유도한상태에서 AED를작동시켰을때에도위음성이나위양성등의오작동은관찰되지않았다. 이렇게실험적으로오작동을재현하지못한이유는여러가지로해석할수있다. 먼저실험횟수의문제로충분한횟수를실험하면다른결과가나왔을가능성이있다. 저자들은 3개의 AED, 2개의심전도리듬, 4개의전자파환경으로총 240회의실험을진행하였는데, 문헌에따라서는최대 8,640회까지다양한횟수의실험을진행한경우도있었다 (Table 2). 따라서실험횟수가많아졌을때추가적인오작동사례가관찰되었을가능성이있다. 두번째는전기장판에서발생되는전자파와실험적으로유발하는전자파의물리적성격이다를가능성이다. 전자파는전기장과자기장이혼재되어있는데, 본연구에서는자기장만유도하여실험을하였으므로전기장판에서발생되는미세한전기장이영향을미칠가능성을배제할수없다. 실제전기장판을이용한실험에서 10회의실험에서 40% 의경우에움직임이감지되는오류가관찰된것을보면실제전기장판과유도된자기장의성격이차이가있을가능성이크다. 저자들은실험연구만으로적절한결론을내리기어려워서전자파가 AED에미치는영향에대한문헌고찰을시행하였다. Stolzenberg 등 4) 은 μt 의자기장이발생
6 236 / 대한응급의학회지 : 제 27 권제 3 호 2016 하는발전소근처에서 AED의판독에이상이없음을보고하였다. Fleischhackl 등 5) 도전기장 V/m, 자기장이 6-29 μt 정도인기차역에서 AED의판독에는이상이없고움직임으로오인하는오류만 0.5% 에서관찰되었다고보고하였다. 그러나 Fleischhackl 등 6) 은다른연구에서 AED가 2.37% (18/760) 에서전자파의영향으로잘못된제세동을권고 ( 위양성 ) 하였으며, 움직임으로오인할가능성은전기장보다는자기장에서높고, 전원주파수가 50 Hz 보다 16.7 Hz 일때더높다고보고하였다. 즉, 전기장이나자기장모두 AED의오작동을유발할수있다는것이다. Kanz 등 7) 은독일의기차역과전철의고압전선에서발생하는전기장이 AED에미치는영향을연구하였는데, 직류 750 V 보다교류 15 kv (16.7 Hz) 에서더많은오작동이발생하였으며 (86% vs 99%), AED 패드가고압전선과수직방향일때보다평행일때오작동이많았다고보고하였다 (97.5% vs 92.4%). 이와같이자기장또는전기장의영향으로 AED의오작동이발생할수있는데최근에는 AED 자체에 16.7 Hz, 50 Hz, 60 Hz 등의전원주파수에의한전자파간섭을필터링하는기술이적용되고있다 2,8). 참고로우리나라의경우전철은 1.5 kv 직류, 철도는 25 kv (60 Hz) 교류전원을사용하고있다. 한편휴대폰에의한무선주파수전자파는 AED의성능에큰영향을미치지않는것으로보고되었다 9-11). 한연구에서는휴대폰사용에의해 AED 안내방송의잡음이보고되었는데, 처음전화벨이울리기 2-4초전부터발생하여벨이울리는동안지속되었다고하며, 15 cm 이상의거리를유지하면예방가능하였다고한다 10). 하지만다른조건과결부되는경우휴대폰의전자파도 AED의성능에영향을미칠수있다. Chalkias 등 12) 은 AED의판독오류가 2.6% (50/1,900) 에서지하철역에서기차가들어오는순간 3.3% 로증가하였으며, 기차가들어올때휴대폰을사용하면 4.2% 로더욱증가했다고보고하였다. 주된판독오류는 VF에서 shock을권고하지않는경우 ( 위음성 ) 였다고한다. Kanz 등 7) 의연구와다르게 AED 패드가고압전선과평행일때보다수직일때에의미있게오작동이증가하였다고한다. 의료장비에서발생하는전자파가 AED에영향을미치는경우도보고된바있는데, 이동식흡인기 (Laerdal LSU 4000) 에서 180 V/m의전기장이발생되어응급카트에나란히비치된 HeartStart MRx (Philips) 제세동기에영향을미쳐오작동을유발하였다고하였다 13). AED와같은응급의료장비는 10 V/m의간섭에견딜수있도록권고되고있으며, 해당이동식흡인기에서발생한전자파는 1m 떨어진거리에서허용기준에적합한수준으로감소되었다고한다. 이상의문헌고찰을통해서경우에따라전자기간섭에의한 AED의다양한오작동이발생가능함을알수있었다. 이번실험은몇가지한계를가지고있다. 먼저인체를 대상으로 AED를적용한실험이아니라는점이다. AED에대한전자파간섭을연구할때인체를대상으로하는경우에마네킨에심전도를발생시켜실험하는것보다간섭이심하게일어난다고알려져있다 14,15). 둘째, AED를평가하는실험횟수가적었다는점이다. Kerber 등 16) 은 AED를평가할때필요한표본수를제안하였는데, 제세동필요리듬의경우 90% 이상의민감도를목표로 200회이상의실험이요구되며, 제세동불필요리듬의경우 99% 이상의특이도를목표로 100회이상의실험이필요하다고하였다. 저자들은조건별로 10회씩총 240회의실험을진행하였으나, 외부기관의협조를얻어실험을진행하는관계로충분한횟수의실험을진행할수없었다. 추후다양한전기장과자기장을유도한상황에서더많은횟수의실험이진행될필요가있다. 결 저자들은이번실험을통해유도된자기장으로상용중인 AED의오작동을재현하지는못했으나전기장판에서발생되는전자파가움직임으로인식될수있음을확인하였다. 따라서 AED를사용할때환자나 AED가전자파를발생할수있는가전제품이나의료장비와가까이위치하지않도록주의할필요가있을것으로사료된다. 론 참고문헌 01. Ku JE, You JS, Joo YS, Chung HS, Chung SP, Lee HS. Accuracy of the automatic external defibrillator on an electric mattress: simulation study. J Korean Soc Emerg Med. 2013;24: Jekova I, Krasteva V, Ménétré S, Stoyanov T, Christov I, Fleischhackl R, et al. Bench study of the accuracy of a commercial AED arrhythmia analysis algorithm in the presence of electromagnetic interferences. Physiol Meas. 2009;30: Kim YS, Kim SY, Park JY, Choi WU. Measurement and personal exposure assessment of extremely low frequency electromagnetic fields. Korean J Environ Health Sci. 1997;23: Stolzenberg BT, Kupas DF, Wieczorek BJ, Sole DP. Automated external defibrillators appropriately recognize ventricular fibrillation in electromagnetic fields. Prehosp Emerg Care. 2002;6: Fleischhackl R, Singer F, Roessler B, Arrich J, Fleischhackl S, Losert H, et al. Automated external defibrillators do not recommend false positive shocks under the influence of electromagnetic fields present at public loca-
7 구재은외 : 전자기장간섭이자동제세동기에미치는영향 : 실험연구및문헌고찰 / 237 tions. Anesth Analg. 2006;103: Fleischhackl R, Singer F, Nitsche W, Gamperl G, Roessler B, Arrich J, et al. Influence of electromagnetic fields on function of automated external defibrillators. Acad Emerg Med. 2006;13: Kanz KG, Kay MV, Biberthaler P, Russ W, Wessel S, Lackner CK, et al. Susceptibility of automated external defibrillators to train overhead lines and metro third rails. Resuscitation. 2004;62: Schlimp CJ, Breiteneder M, Lederer W. Heightened awareness of safety aspects concerning public access defibrillation near high-voltage power lines with 16.7-Hz alternating current. Acta Anaesthesiol Scand. 2005;49: Kanz KG, Kay MV, Biberthaler P, Russ W, Lackner CK, Mutschler W. Effect of digital cellular phones on tachyarrhythmia analysis of automated external defibrillators. Eur J Emerg Med. 2004;11: Trigano A, Blandeau O, Dale C, Wong MF, Wiart J. Clinical testing of cellular phone ringing interference with automated external defibrillators. Resuscitation. 2006; 71: Karczmarewicz S, Janusek D, Buczkowski T, Gutkowski R, Kulakowski P. Influence of mobile phones on accuracy of ECG interpretation algorithm in automated external defibrillator. Resuscitation. 2001;51: Chalkias A, Koutsovasilis A, Raffay V, Sandroni C, Jaskula J, Iacovidou N, et al. Influence of electromagnetic interference on AED function in metro stations. Int J Cardiol. 2013;168: Lee SM, Hyde D, Dimunge A, Grant LJ. Defibrillators can be susceptible to electromagnetic fields from adjacent portable suction units. Resuscitation. 2014;85:e Schlimp CJ, Breiteneder M, Lederer W. Safety aspects for public access defibrillation using automated external defibrillators near high-voltage power lines. Acta Anaesthesiol Scand. 2004;48: Schlimp CJ, Lederer W, Breiteneder M. Influence of electromagnetic interference on the human electrocardiogram in automated external defibrillators. Resuscitation. 2005;66:105-6 (author reply 6-7). 16. Kerber RE, Becker LB, Bourland JD, Cummins RO, Hallstrom AP, Michos MB, et al. Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997;95:
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