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<h2>Ïðèëîæåíèå B</h2>
<h3>Ïðåäëàãàåìûå ïðîöåäóðû äëÿ òåñòèðîâàíèÿ êîììåð÷åñêîãî îáîðóäîâàíèÿ, ïðåäíàçíà÷åííîãî äëÿ îöåíêè âàðèàáåëüíîñòè ñåðäå÷íîãî ðèòìà</h3>
<I><p><dd>Êîíöåïöèÿ</I>
<p><dd>Äëÿ äîñòèæåíèÿ ñðàâíèòåëüíîé òî÷íîñòè èçìåðåíèé ïðè ïðèìåíåíèè ðàçëè÷íûõ ïðèáîðîâ êàæäûé ïðèáîð äîëæåí ïðèõîäèòü íåçàâèñîìîå îò ïðîèçâîäèòåëÿ òåñòèðîâàíèå (íàïð. â èññëåäîâàòåëüñêîì ó÷åðåæäåíè). Êàæäûé òåñò äîëæåí âêëþ÷àòü â ñåáÿ íåñêîëüêî êîðîòêèõ è, åñëè âîçìîæíî, äîëãîâðåìåííûõ òåñòîâûõ ðåãèñòðàöèé ñ çàðàíåå òî÷íî èçâåñòíûìè ïàðàìåòðàìè ÂÑÐ è ðàçëè÷íûìè ìîðôîëîãè÷åñêèìè õàðàêòåðèñòèêàìè ÝÊà ñèãíàëà. Åñëè äëÿ ïðîâåäåíèÿ ïðîöåäóðû òåñòèðîâàíèÿ íåîáõîäèìî ïðèâëå÷åíèå ïðîèçâîäèòåëÿ (íàïðèìåð äëÿ ðåäàêòèðîâàíèÿ ìàðêèðîâêè êîìïëåêñîâ QRS âðó÷íóþ), ïðîèçâîäèòåëü íå äîëæåí çíàòü èñòèííûõ õàðàêòåðèñòèê ÂÑÐ òåñòîâûõ çàïèñåé è ïàðàìåòðîâ ðåãèñòðàöèè ñèãíàëà.  ÷àñòíîñòè, ïðè ðàñêðûòèè ðåçóëüòàòîâ òåñòèðîâàíèÿ ïðîèçâîäèòåëþ äëÿ äàëüíåéøåãî óëó÷øåíèÿ ïðèáîðà èëè èíûõ öåëåé, â íîâûõ òåñòàõ äîëæíû ïðèìåíÿòüñÿ ñîâåðøåííî íîâûå òåñòîâûå ðåãèñòðàöèè.
<I><p><dd>Òåõíè÷åñêèå òðåáîâàíèÿ</I>
<p><dd>Òåñòèðîâàíèå äîëæíî ïðîèçâîäèòüñÿ â îòíîøåíèè âñåõ ñîñòàâíûõ ÷àñòåé îáîðóäîâàíèÿ.  ÷àñòíîñòè, òåñòó äîëæíû ïîäâåðãàòüñÿ è ðåãèñòðèðóþùàÿ è àíàëèòè÷åñêàÿ ñîñòàâëÿþùèå ïððèáîðà. Ñîîòâåòñòâóþùàÿ òåõíîëîãèÿ äîëæíà ïðèìåíÿòüñÿ äëÿ ðåãèñòðàöèè ïîëíîñòüþ âîñïðîèçâîäèìîãî ñèãíàëà ñ çàðàíåå èçâåñòíâìè ïàðàìåòðàìè ÂÑÐ, ò.å. òåñòîâûé ñèãíàë äîëæåí áûòü ïðîèçâåäåí êîìïüþòåðîì èëè èíûì òåõíè÷åñêèì óñòðîéñòâîì.  òåñòàõ äîëæíû èñïîëüçîâàòüñÿ êàê íîâûå, òàê è áûâøèå â óïîòðåáëåíèè â òå÷åíèå ïðèáëèçèòåëü íî ïîëîâèíû ñðîêà ñëóæáû ðåãèñòðàòîðû. Òåñòèðîâà íèå âïåðâûå âûïóñêàåìûõ íà ðûíîê ñèñòåì íå äîëæíî çàäåðæèâàòüñÿ. Åñëè ïðîèçâîäèòåëü óòâåðæäàåò, ÷òî åãî ïðèáîð ñïîñîáåí àíàëèçèðîâàòü çàïèñè ÝÊà (íàïðèìåð ëåíòû Õîëòåðà), ïîëó÷åííûå ñ ïðèáîðîâ äðóãèõ ïðîèçâîäèòåëåé, êàæäàÿ êîìáèíàöèÿ äîëæíà òåñòèðîâàòüñÿ íåçàâèñèìî.
<p><dd>Ïîñêîëüêó ïîæíî ïðåäñêàçàòü àíàëèç ÂÑÐ èìïëàíòèðóåìûìè óñòðîéñòâàìè, ïîäîáíûå ïðîöåäóðû äîëæíû èñïîëüçîâàòüñÿ è äëÿ ãåíåðàöèè ñèìóëèðîâàííîãî âíóòðèñåðäå÷íîãî ñèãíàëà. Ïî âîçìîæíîñòè òåñòèðîâàòüñÿ äîëæíû èìïëàíòèðóåìûå óñòðîéñòâà êàê ñ ïîëíîñòüþ çàðÿæåííîé, òàê è ÷àñòè÷íî ðàçðÿæåííîé áàòàðååé.
<I><p><dd>Òåñòîâûå ðåãèñòðàöèè</I>
<p><dd>Íåçàâèñèìî îò èñïîëüçîâàííîãî îáîðóäîâàíèÿ êðàéíå òðóäíî òî÷íî çíàòü ïàðàìåòðû ÂÑÐ ëþáîé ðåàëüíîé çàïèñè ÝÊÃ. Ñëåäîâàòåëüíî ïðåäïî÷òåíèå ñëåäóåò îòäàâàòü ñèìóëèðîâàííûì ñèãíàëàì ÝÊÃ. Îäíàêî ìîðôîëîãèÿ òàêèõ ñèìóëèðîâàííûõ ñèãíàëîâ, êàê è õàðàêòåðèñòèêè ÂÑÐ, äîëæíî áûòü áëèçêè ê ðåàëüíûì ðåãèñòðàöèÿì. ×àñòîòà äèñêðåòèçàöèè, èñïîëüçóåìàÿ äëÿ ãåíåðàöèè òàêèõ ñèãíàëîâ äîëæíà áûòü ñóùåñòâåííî âûøå, ÷åì ÷àñòîòà, èñïîëüçóåìàÿ òåñòèðóåìûì óñòðîéñòâîì. Ïðè ïðîèçâîäñòâå òåñòîâûõ çàïèñåé äîëæíû ñèìóëèðîâàòüñÿ âîçäåéñòâèÿ, êîòîðûå âëèÿþò èëè ìîãóò âëèÿòü íà òî÷íîñòü îïðåäåëåíèÿ ÂÑÐ, íàïðèìåð âàðüèðóþùèé óðîâåíü øóìà, âàðèàáåëüíàÿ ìîðôîëîãèÿ êîìïëåêñà QRS, ñïîñîáíàÿ âûçâàòü ñìåùåíèå îòïðàâíîé òî÷êè, ñëó÷àéíûå øóìîâûå ïîìåõè â ðàçëè÷íûõ êàíàëàõ ðåãèñòðàöèè, ïîñòåïåííûå è âíåçàïíûå èçìåíåíèÿ õàðàêòåðèñòèê ÂÑÐ è ðàçëè÷íûå ÷àñòîòû ïðåäñåðäíûõ è æåëóäî÷êîâûõ ýêñòðàñèñòîë ñ ðåàëèñòè÷íûìè ìîðôîëîãèÿìè ñèãíàëà.
<p><dd>Êà÷åñòâî ðåãèñòðàöèé íà ìàãíèòíîé ëåíòå ìîæåò íå áûòü ïîñòîÿííûì â òå÷åíèå äîëãîâðåìåííûõ ðåãèñòðàöèé âñëåäñòâèå íåðàâíîìåðíîãî íàòÿæåíèÿ, ñêîðîñòè âðàùåíèÿ è èíûõ ôàêòîðîâ. Ôóíêöèîíè ðîâàíèå âñåõ ðåãèñòðàòîðîâ íàõîäèòñÿ ïîä âíåøíèì âëèÿíèåì ôàêòîðîâ îêðóæàþùåé ñðåäû. Ïî ýòîé ïðè÷èíå ïðåäïî÷òèòåëüíûìè ÿâëÿþòñÿ òåñòû ñ äîëãîâðåìåííîé ðåãèñòðàöèåé (íàïðèìåð ïîëíûé 24-÷àñîâîé òåñò).
<I><p><dd>Ïðîöåäóðû òåñòèðîâàíèÿ</I>
<p><dd>Êàæäîå óñòðîéñòâî èëè ëþáàÿ åãî êîíôèãóðà öèÿ äîëæíû òåñòèðîâàòüñÿ ñ èñïîëüçîâàíèåì ðàçëè÷íûõ çàïèñåé, îáëàäàþùèõ ðàçëè÷íûìè ÷åðòàìè è ðàçíûìè õàðàêòåðèñòèêàìè ÂÑÐ. Ïàðàìåòðû ÂÑÐ êàæäîé òåñòîâîé çàïèñè è êàæäîãî âûáðàííîãî ñåãìåíòà ðåãèñòðàöèè, ïîëó÷åííûõ ïðè èñïîëüçîâàíèè êîììåð÷åñêîãî óñòðîéñòâà, äîëæíû ñðàâíèâàòüñÿ ñ èçâåñòíûìè õàðàêòåðèñòèêàìè èñõîäíîãî ñèãíàëà. Ëþáûå âûÿâëåííûå ðàçëè÷èÿ äîëæíû áûòü ïðîàíàëèçèðîâàíû â îòíîøåíèè ñïåöèàëüíûõ õàðàêòåðè ñòèê, âíåñåííûõ â òåñòîâóþ çàïèñü, íàïðèìåð ïîâûøåííûì øóìîì, áëóæäàíèåì îòïðàâíîé òî÷êè è ò.ï. Äîëæíû áûòü îïðåäåëåíû ñèñòåìíàÿ îøèáêà îáîðóäîâàíèÿ è îòíîñèòåëüíûå ïîãðåøíîñòè.
<I><p><dd>Ñîîáùåíèå ðåçóëüòàòîâ</I>
<p><dd>Òåõíè÷åñêèé îò÷åò î òåñòèðîâàíèè äîëæåí áûòü ïîäãîòîâëåí èñêëþ÷èòåëüíî òåñòèðóþùåé îðãàíèçàöèåé íåçàâèñèìî îò ïðîèçâîäèòåëÿ òåñòèðóåìîãî óñòðîéñòâà.
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