{"id":3538,"date":"2019-07-29T08:09:40","date_gmt":"2019-07-29T06:09:40","guid":{"rendered":"http:\/\/medtech-ingenieur.de\/?p=3538"},"modified":"2021-08-06T14:37:40","modified_gmt":"2021-08-06T13:37:40","slug":"defibrillationsgeschuetzte-anwendungsteile","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/defibrillationsgeschuetzte-anwendungsteile\/","title":{"rendered":"Defibrillation-protected applied parts"},"content":{"rendered":"<div style=\"direction: ltr; border-width: 100%;\">\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">\n<div>60601-1 defines defibrillation-protected applied parts (commonly referred to as defibrillation-resistant). Applied parts must be as defined in other articles (e.g., <a href=\"https:\/\/medtech-ingenieur.de\/en\/elektrische-sicherheit-in-der-medizintechnik-nach-60601-1\/\">here<\/a>) as already described. For some application parts, defibrillation resistance is required by standards (e.g., 60601-2-27 for ECG).<\/div>\n<div><\/div>\n<p>&nbsp;<\/p>\n<div>A defibrillation-protected applied part refers to the property of an applied part to function when used simultaneously with a defibrillator without impairing the function of the defibrillator.<\/div>\n<div><\/div>\n<div>The fulfillment of this property is tested in 60601-1 through three tests:<\/div>\n<p>&nbsp;<\/p>\n<ul>\n<li><strong>Common mode test<\/strong><\/li>\n<\/ul>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">Apply a defibrillation pulse to all interconnected patient terminals against protective conductors or earth. Ensure that no hazardous voltages are present at any other outputs and connections (and accessible metallic parts).<\/p>\n<ul>\n<li><strong>Differential clock test<\/strong><\/li>\n<\/ul>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">Apply a defibrillation pulse to each patient terminal individually, with the other patient terminals connected to ground. Again, no hazardous voltages may be present at any other outputs or terminals.<\/p>\n<ul>\n<li><strong>Energy reduction test<\/strong><\/li>\n<\/ul>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">The energy delivered to the patient may be reduced by a maximum of 10 % by a defibrillation-protected applied part, so that the effectiveness of the defibrillation is maintained.<\/p>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">After all tests, the basic safety and essential performance characteristics of the tested device must still be met. The tests and corresponding test setups are described in detail in 60601-1 and will not be discussed further here. The setup is shown in principle in the following figure.<\/p>\n<p><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup.png\"><img loading=\"lazy\" decoding=\"async\" class=\"invertImg alignnone wp-image-3539 size-medium\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-300x300.png\" alt=\"\" width=\"300\" height=\"300\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-300x299.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-150x149.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-100x100.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-200x199.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup-450x448.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/TestSetup.png 586w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">In addition, there is a requirement that the clearance and creepage distances of defibrillation-protected application parts must not be less than 4 mm.<\/p>\n<h4 style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">What does the requirement for a defibrillation-protected application part mean in development?<\/h4>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">For defibrillation-protected devices with a galvanic connection to the patient, such as ECG machines or other stimulation devices, the patient connections must be appropriately protected. There are various topologies for this protection circuit, but essentially the protection circuit consists of a series resistor for current limiting and a component for voltage limiting, such as a diode, Zener diode, or gas discharge tube.<\/p>\n<p><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1.png\"><img loading=\"lazy\" decoding=\"async\" class=\"invertImg alignnone wp-image-3544 size-full\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1.png\" alt=\"\" width=\"680\" height=\"238\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1.png 680w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-300x105.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-100x35.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-150x53.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-200x70.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-450x158.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/07\/ECG1-600x210.png 600w\" sizes=\"auto, (max-width: 680px) 100vw, 680px\" \/><\/a><\/p>\n<p style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">Component specifications vary depending on the application. For example, an ECG input stage should generally have the following characteristics:<\/p>\n<ul>\n<li>Series resistance in the range of 5 kOhm to 50 kOhm for current limiting<\/li>\n<\/ul>\n<p>The series resistance must be specified for:<\/p>\n<ul>\n<li>Pulse load<\/li>\n<li>Dielectric strength<\/li>\n<li>Required air and creepage distances<\/li>\n<\/ul>\n<p>Bypass diodes such as MAX30034 or BAV199 specified for:<\/p>\n<ul>\n<li>Pulse load<\/li>\n<li>Electricity<\/li>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<p>Once a circuit topology has been chosen for the input circuit, it can be easily simulated with Spice. This simplifies component dimensioning, as measurements at high voltages are not so straightforward and subject to significant noise.<\/p>\n<\/div>\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">Ultimately, the circuit must pass the tests defined in 60601-1.<\/div>\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">\n<p>If you have any further questions on this topic, please leave us a comment or send us an email.<\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">Best regards<\/div>\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in;\">\n<p>Martin Bosch<\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>In der 60601-1 gib es die Definition von defibrillationsgesch\u00fctzten Anwendungsteilen (\u00fcblicherweise auch als defibrillationsfest bezeichnet). Anwendungsteile m\u00fcssen wie in anderen Artikeln (z. B. hier) schon beschrieben, klassifiziert werden. F\u00fcr manche Anwendungsteile wird durch Normen (z. B. 60601-2-27 f\u00fcr EKG) Defibrillationsfestigkeit gefordert. &nbsp; Ein defibrillationsgesch\u00fctztes Anwendungsteil bezeichnet die Eigenschaft eines Anwendungsteils, bei gleichzeitiger Anwendung mit einem [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":3539,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,14],"tags":[316,340,157,341,342],"class_list":["post-3538","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hardware-entwicklung","category-normen","tag-316","tag-defibrillation","tag-ekg","tag-gleichtakt","tag-norm","post-wrapper","thrv_wrapper"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Defibrillationsgesch\u00fctzte Anwendungsteile - MEDtech Ingenieur GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medtech-ingenieur.de\/en\/defibrillationsgeschuetzte-anwendungsteile\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Defibrillationsgesch\u00fctzte Anwendungsteile - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"In der 60601-1 gib es die Definition von defibrillationsgesch\u00fctzten Anwendungsteilen (\u00fcblicherweise auch als defibrillationsfest bezeichnet). 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