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摘 要

 

為客觀評估國產和(he)(he)進(jin)(jin)口(kou)(kou)(kou)(kou)心電(dian)(dian)圖(tu)(tu)機(ji)(ji)設(she)備的水平和(he)(he)差異情況，該研(yan)究(jiu)深入對(dui)比驗(yan)評了 5 臺國產心電(dian)(dian)圖(tu)(tu)機(ji)(ji)和(he)(he) 1 臺進(jin)(jin)口(kou)(kou)(kou)(kou)心電(dian)(dian)圖(tu)(tu)機(ji)(ji)的性(xing)(xing)(xing)(xing)能指(zhi)標及可靠性(xing)(xing)(xing)(xing)。結果(guo)表(biao)明(ming)，國產樣(yang)(yang)(yang)機(ji)(ji)的低頻特性(xing)(xing)(xing)(xing)、對(dui)心電(dian)(dian)圖(tu)(tu)波形間期(qi)和(he)(he)時(shi)限的自動測量準確性(xing)(xing)(xing)(xing)次于進(jin)(jin)口(kou)(kou)(kou)(kou)樣(yang)(yang)(yang)機(ji)(ji)，但高頻響(xiang)應、基線穩(wen)定性(xing)(xing)(xing)(xing)、抗噪聲自動測量穩(wen)定性(xing)(xing)(xing)(xing)優(you)于進(jin)(jin)口(kou)(kou)(kou)(kou)樣(yang)(yang)(yang)機(ji)(ji)。其他項測試的性(xing)(xing)(xing)(xing)能指(zhi)標在國產和(he)(he)進(jin)(jin)口(kou)(kou)(kou)(kou)心電(dian)(dian)圖(tu)(tu)機(ji)(ji)樣(yang)(yang)(yang)機(ji)(ji)間并無明(ming)顯不同。通過分析國產樣(yang)(yang)(yang)機(ji)(ji)和(he)(he)進(jin)(jin)口(kou)(kou)(kou)(kou)心電(dian)(dian)圖(tu)(tu)機(ji)(ji)的對(dui)比結果(guo)，可在一定程度上(shang)反映出目前國產心電(dian)(dian)圖(tu)(tu)機(ji)(ji)設(she)備與(yu)進(jin)(jin)口(kou)(kou)(kou)(kou)設(she)備間的差異，為國產心電(dian)(dian)圖(tu)(tu)機(ji)(ji)設(she)備的研(yan)發改(gai)進(jin)(jin)提供(gong)參考。

 

心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)可(ke)(ke)(ke)用于(yu)記錄(lu)人體心(xin)(xin)(xin)(xin)臟動(dong)作電(dian)(dian)(dian)位(wei)，并可(ke)(ke)(ke)對心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)進(jin)行精密(mi)測(ce)量(liang)，是醫(yi)療領域(yu)不可(ke)(ke)(ke)或缺的(de)(de)重要診斷(duan)工具 [1-4]。在(zai)醫(yi)院(yuan)、科(ke)研(yan)院(yuan)所等(deng)實際使(shi)用環(huan)境中，不同(tong)心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)的(de)(de)安(an)全性(xing)、有(you)(you)效(xiao)性(xing)等(deng)方面(mian)可(ke)(ke)(ke)能(neng)(neng)會存在(zai)一定差異。目前(qian)，進(jin)口心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)在(zai)國內(nei)的(de)(de)總體認(ren)可(ke)(ke)(ke)度較高。隨著國內(nei)科(ke)技(ji)和相關產業的(de)(de)發展(zhan)(zhan)，國產心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)的(de)(de)安(an)全性(xing)、有(you)(you)效(xiao)性(xing)及性(xing)價比均有(you)(you)較大進(jin)步(bu)。為推動(dong)國產心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)的(de)(de)發展(zhan)(zhan)，本研(yan)究從技(ji)術角度深(shen)入剖(pou)析(xi)了主(zhu)(zhu)流國產心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)的(de)(de)主(zhu)(zhu)要性(xing)能(neng)(neng)特征(zheng)，并與進(jin)口心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)進(jin)行對比驗(yan)(yan)評。驗(yan)(yan)評方案基于(yu)心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)國內(nei)外(wai)標(biao)(biao)準(zhun) [5-8] 的(de)(de)要求、檢驗(yan)(yan)方法，并結合(he)以往心(xin)(xin)(xin)(xin)電(dian)(dian)(dian)圖(tu)機(ji)的(de)(de)監督抽(chou)驗(yan)(yan)、專(zhuan)項抽(chou)驗(yan)(yan)結果及經驗(yan)(yan)，同(tong)時考(kao)慮臨床應用需求，對國內(nei)外(wai)標(biao)(biao)準(zhun)中的(de)(de)技(ji)術指標(biao)(biao)進(jin)行了篩選和調(diao)整，內(nei)容涉及性(xing)能(neng)(neng)（含自(zi)動(dong)測(ce)量(liang)準(zhun)確(que)性(xing)性(xing)能(neng)(neng)）、安(an)全和可(ke)(ke)(ke)靠性(xing)，現報道如下。

 

1. 對象(xiang)與(yu)方法

 

1.1  測試(shi)對象

 

對比驗(yan)評共(gong)選取 6 臺心(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)機，涉及(ji) 4 家生產企業(ye)、6 個型(xing)(xing)號(hao)（A~F）。其中(zhong)(zhong)，A 型(xing)(xing)號(hao)為(wei)(wei)進口心(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)機，作為(wei)(wei)對比驗(yan)評參(can)考設備；B~F 型(xing)(xing)號(hao)為(wei)(wei)國(guo)產心(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)機；E 型(xing)(xing)號(hao)為(wei)(wei)計算(suan)機 USB 供(gong)電(dian)(dian)(dian)(dian)方(fang)式，其余 5 臺均(jun)為(wei)(wei)網(wang)電(dian)(dian)(dian)(dian)源(yuan)供(gong)電(dian)(dian)(dian)(dian)及(ji)內(nei)部電(dian)(dian)(dian)(dian)源(yuan)供(gong)電(dian)(dian)(dian)(dian)方(fang)式；除 E 型(xing)(xing)號(hao)外，其余均(jun)有心(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)的(de)自動分(fen)(fen)析診(zhen)斷功(gong)能(neng)。參(can)與(yu)自動分(fen)(fen)析診(zhen)斷功(gong)能(neng)測試的(de)是 A、C（B、C、D 型(xing)(xing)號(hao)使用同一自動分(fen)(fen)析算(suan)法）和(he) F 型(xing)(xing)號(hao)心(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)機。導(dao)聯線(xian)試驗(yan)中(zhong)(zhong)，A、B、C（D 與(yu) C 型(xing)(xing)號(hao)共(gong)用）、E 和(he) F 型(xing)(xing)號(hao)，其中(zhong)(zhong) E 型(xing)(xing)號(hao)無電(dian)(dian)(dian)(dian)纜與(yu)導(dao)聯線(xian)連接器(qi)。

 

1.2  方法(fa)

 

1.2.1  測試條件

 

測(ce)試(shi)環(huan)境溫度(du)為 5 ~ 40 ℃，相對濕度(du) 25% ~ 95%（無(wu)冷凝(ning)），大氣壓為 700 ~ 1 060 hPa。

 

供電(dian)(dian)(dian)(dian)(dian)(dian)(dian)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)壓(ya)和(he)試(shi)(shi)(shi)驗(yan)(yan)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)壓(ya)、電(dian)(dian)(dian)(dian)(dian)(dian)(dian)流類型、電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)類別、頻率的具(ju)體測試(shi)(shi)(shi)條(tiao)件(jian)如下(xia)。（1）交流工作(zuo)模(mo)式的心(xin)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)圖機，除另有(you)說(shuo)明(ming)(ming)(ming)，試(shi)(shi)(shi)驗(yan)(yan)時供電(dian)(dian)(dian)(dian)(dian)(dian)(dian)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)壓(ya)應(ying)為電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)壓(ya)：（220±22）V（有(you)效(xiao)值(zhi)），電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)頻率（50±1）Hz。（2）直(zhi)流工作(zuo)模(mo)式的心(xin)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)圖機，采用直(zhi)流電(dian)(dian)(dian)(dian)(dian)(dian)(dian)試(shi)(shi)(shi)驗(yan)(yan)。按(an)照使(shi)(shi)用說(shuo)明(ming)(ming)(ming)書，應(ying)考慮極性(xing)對設(she)備(bei)運(yun)(yun)行(xing)可(ke)能產生的影響。除另有(you)說(shuo)明(ming)(ming)(ming)，具(ju)有(you)內部電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)的心(xin)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)圖機使(shi)(shi)用制(zhi)造商指定的內部電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)額定電(dian)(dian)(dian)(dian)(dian)(dian)(dian)壓(ya)測試(shi)(shi)(shi)。（3）規定要和(he)特定電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)一同使(shi)(shi)用的心(xin)電(dian)(dian)(dian)(dian)(dian)(dian)(dian)圖機，與該指定電(dian)(dian)(dian)(dian)(dian)(dian)(dian)源(yuan)(yuan)(yuan)一同進(jin)行(xing)試(shi)(shi)(shi)驗(yan)(yan)。另外(wai)，設(she)備(bei)在最(zui)不利的規定工作(zuo)條(tiao)件(jian)下(xia)進(jin)行(xing)試(shi)(shi)(shi)驗(yan)(yan)。運(yun)(yun)行(xing)值(zhi)可(ke)由操作(zuo)者調整或控制(zhi)的設(she)備(bei)，在試(shi)(shi)(shi)驗(yan)(yan)時應(ying)將運(yun)(yun)行(xing)值(zhi)調至對相應(ying)試(shi)(shi)(shi)驗(yan)(yan)最(zui)不利的值(zhi)。試(shi)(shi)(shi)驗(yan)(yan)時，均使(shi)(shi)用制(zhi)造商所指定的配(pei)件(jian)及打印紙記錄材料。

 

1.2.2  預處理

 

試(shi)驗(yan)開始前，心(xin)電圖(tu)機應在不工作(zuo)情況下放置于試(shi)驗(yan)場(chang)所至少 24 h。試(shi)驗(yan)前，按使(shi)用說明書(shu)要求，在額定電壓下運轉設(she)備(bei)直至能(neng)進(jin)行試(shi)驗(yan)。

 

1.2.3  測試(shi)指標及(ji)方法(fa)

 

性(xing)(xing)能(neng)指標(biao)包(bao)括輸入(ru)阻抗、靈敏(min)度（精確度、穩(wen)定(ding)性(xing)(xing)）、對不(bu)(bu)需要的(de)外部(bu)電(dian)(dian)(dian)壓(ya)信號的(de)抑制 [ 共(gong)模(mo)抑制、過載(zai)容限、濾波器（采用 CTS 數據庫(ku)的(de)ANE20000 測(ce)試）]、基線（穩(wen)定(ding)性(xing)(xing)、噪(zao)聲電(dian)(dian)(dian)平、描記(ji)速(su)度及(ji)軌跡寬(kuan)度、多道(dao)(dao)心電(dian)(dian)(dian)圖機的(de)道(dao)(dao)間干擾）、失(shi)真（頻率響(xiang)應(ying)、線性(xing)(xing)和(he)(he)動態范圍、最小信號響(xiang)應(ying)）、打(da)印及(ji)電(dian)(dian)(dian)子(zi)存儲與傳(chuan)輸、除(chu)(chu)顫(zhan)(zhan)(zhan)(zhan)過載(zai)保護（除(chu)(chu)顫(zhan)(zhan)(zhan)(zhan)恢(hui)復、釋放給患(huan)者能(neng)量的(de)損(sun)失(shi)）、工作(zuo)數據準(zhun)確性(xing)(xing) [ 心電(dian)(dian)(dian)圖自動測(ce)量（含振幅(fu)測(ce)量、間期測(ce)量、抗噪(zao)測(ce)量穩(wen)定(ding)性(xing)(xing)）準(zhun)確性(xing)(xing) ]。性(xing)(xing)能(neng)指標(biao)測(ce)試方(fang)法主(zhu)要參照行(xing)業標(biao)準(zhun)。其中(zhong)，個別(bie)指標(biao)基于對比目的(de)有所調整。YY 1139-2013《心電(dian)(dian)(dian)診斷設(she)(she)備(bei)》[6] 中(zhong) 4.2.7.2 頻率響(xiang)應(ying)方(fang)法 A：在標(biao)準(zhun)要求（標(biao)準(zhun)靈敏(min)度下，輸入(ru) 1.0 mV 正弦波）基礎上擴寬(kuan)考察帶寬(kuan)，增(zeng)加多個測(ce)試點（0.01、0.05、150、300、400、500 Hz）；4.2.14.2 對恢(hui)復和(he)(he)釋放給患(huan)者能(neng)量的(de)損(sun)失(shi)均進行(xing)選擇性(xing)(xing)導聯(lian)測(ce)試，分別(bie)對R 導聯(lian)、C2 導聯(lian)施加除(chu)(chu)顫(zhan)(zhan)(zhan)(zhan)電(dian)(dian)(dian)壓(ya)（+/-），導聯(lian)設(she)(she)置為Ⅱ和(he)(he) C2，以一定(ding)程度上在測(ce)試對比不(bu)(bu)同產品除(chu)(chu)顫(zhan)(zhan)(zhan)(zhan)過載(zai)保護能(neng)力(li)之(zhi)外，減少多次除(chu)(chu)顫(zhan)(zhan)(zhan)(zhan)對樣機的(de)損(sun)傷。

 

進行(xing)工(gong)作數據準確性(xing)測試時(shi)，所有(you)樣機均采用模擬(ni)信(xin)號形式(shi)測試，即待測心電圖機以心電導(dao)聯線(xian)連接(jie)信(xin)號源，采集(ji)模擬(ni)形式(shi)心電信(xin)號，隨后自動(dong)進行(xing)處(chu)理(li)、存儲及(ji)分析，50 Hz 工(gong)頻(pin)濾(lv)波(bo)器(qi)(qi)等所有(you)濾(lv)波(bo)器(qi)(qi)均關閉(bi)。此指標對比時(shi)的允許誤差(cha)限值(zhi)參照行(xing)業(ye)標準 [5] 要求。噪(zao)聲干(gan)擾測試則包括高頻(pin)噪(zao)聲、基線(xian)漂移和工(gong)頻(pin)干(gan)擾 3 種類型噪(zao)聲。

 

可靠性指標包括環(huan)境試驗（氣(qi)候環(huan)境對靈(ling)敏度(du)的精確(que)度(du)的沖擊，見表 1）、導(dao)聯(lian)線(xian)(xian)彎曲(qu)(qu)壽命和連(lian)接器(qi)(qi)的插拔次數(shu)。以上指標均按照行(xing)業標準 [9-10] 方法測試。考慮心(xin)電(dian)(dian)圖機導(dao)聯(lian)線(xian)(xian)的臨床(chuang)應用可靠性，參(can)考心(xin)電(dian)(dian)監護儀導(dao)聯(lian)線(xian)(xian)行(xing)業標準 [10] 增加相關指標：導(dao)聯(lian)線(xian)(xian)彎曲(qu)(qu)壽命和連(lian)接器(qi)(qi)的插拔次數(shu)。前者(zhe)(zhe)關注設備連(lian)接器(qi)(qi)與(yu)主(zhu)電(dian)(dian)纜(lan)連(lian)接處、主(zhu)電(dian)(dian)纜(lan)與(yu)電(dian)(dian)纜(lan)分線(xian)(xian)盒的連(lian)接處、患者(zhe)(zhe)導(dao)聯(lian)線(xian)(xian)與(yu)導(dao)聯(lian)線(xian)(xian)連(lian)接器(qi)(qi)連(lian)接處及(ji)患者(zhe)(zhe)導(dao)聯(lian)線(xian)(xian)與(yu)患者(zhe)(zhe)終端連(lian)接處的彎曲(qu)(qu)壽命。

 

表(biao) 1 環境試驗(yan)項目及試驗(yan)要求(qiu)

注：E 型號為計算機 USB 供(gong)電(dian)方式，電(dian)源電(dian)壓指(zhi)為其供(gong)電(dian)的計算機額定電(dian)壓

 

2.  結(jie)果

 

2.1  性能(neng)測試結果

 

2.1.1  靈(ling)敏度精確度及穩定性測試結果(guo)

 

A~F 型號靈(ling)敏度(du)精確度(du)誤差的結(jie)果(guo)依次為 0.0%、1.0%、0.0%、0.0%、0.0% 和(he) 1.2%；靈(ling)敏度(du)穩定性(xing)，即在開機(ji) 1 min 及 1 h 后心電圖記(ji)錄(lu)的靈(ling)敏度(du)最大(da)變化(hua)依次為 0.0%、2.5%、0.0%、0.0%、0.0% 和(he) 0.8%，見表 2。

 

表 2 性能測試結果（部分）

 

 

注：A 型號為(wei)進(jin)口心(xin)電(dian)圖(tu)機，B ~ F 型號為(wei)國產(chan)心(xin)電(dian)圖(tu)機

 

2.1.2  高頻響應測(ce)試結(jie)果

 

進(jin)行通頻(pin)帶(dai)測(ce)(ce)(ce)試(shi)以(yi)進(jin)一步分析不同心電圖機的性能差異，擴展(zhan)頻(pin)率(lv)響應(ying)測(ce)(ce)(ce)試(shi)頻(pin)率(lv)點，測(ce)(ce)(ce)試(shi)其在0.01、0.05、0.67、10、40、100、150、300、400、500 Hz 頻(pin)率(lv)點，相對(dui)于 10 Hz 正弦輸入信(xin)號輸出幅度，見(jian)表(biao) 3 和圖 1。

 

表 3 高(gao)頻響應的部分結果（含擴展頻率點）

 

注：A 型(xing)號(hao)(hao)為進口心電圖機(ji)，B ~ F 型(xing)號(hao)(hao)為國產心電圖機(ji)

 

 

注(zhu)：B 型(xing)號和 C 型(xing)號測(ce)試(shi)值(zhi)相同，曲線完全重(zhong)合(he)

 

圖 1 1.0 mV 正弦輸入(ru)信(xin)號的高頻響(xiang)應結果示意圖

 

2.1.3  輸入阻抗測試結果

 

在 0.5、10 Hz 測試(shi)點(dian)及存(cun)在極化電(dian)壓情況下，心電(dian)圖機(ji)在加入阻(zu)抗后的信號衰(shuai)減(jian)(jian)均不大（≤ 2.5%）。但在 100 Hz 測試(shi)點(dian)時，A ~ F 型號則依次衰(shuai)減(jian)(jian)18.2%、10.5%、12.8%、13.2%、14.7%和18.9%，見表 4。

 

表(biao) 4 輸入阻抗測試(shi)結果

 

 

注：A 型號為(wei)進口(kou)心電(dian)圖(tu)機(ji)(ji)，B ~ F 型號為(wei)國產心電(dian)圖(tu)機(ji)(ji)

 

2.1.4  除顫防護測試結果

 

A ~ F 型(xing)號(hao)(hao)心電(dian)圖(tu)機(ji)在(zai)除顫后 5 s 內均可自(zi)動恢(hui)復(fu)（標準靈敏度下），波形恢(hui)復(fu)至(zhi)正(zheng)常幅度 80%的(de)(de)時間依(yi)次(ci)為 3.1、2.4、1.9、1.9、3.6、4.0 s。在(zai)進行(xing)能(neng)量減少試驗(yan)時，A ~ F 型(xing)號(hao)(hao)心電(dian)圖(tu)機(ji)釋放(fang)給患者的(de)(de)能(neng)量損失依(yi)次(ci)為 2.4%、3.0%、3.0%、5.5%、1.9%、1.0%。

 

2.2  自動測(ce)量準(zhun)確(que)性結(jie)果

 

心電(dian)圖機對整(zheng)體(ti)間期(qi)和波(bo)形(xing)時限(xian)測(ce)(ce)量及 Q、R、S 波(bo)的時限(xian)測(ce)(ce)量的結果見(jian)表(biao) 5。心電(dian)圖機在有無噪聲干(gan)擾(rao)情(qing)況下對心電(dian)圖整(zheng)體(ti)間期(qi)測(ce)(ce)量的準確(que)性結果見(jian)表(biao) 6。

 

表(biao) 5 絕(jue)對間期(qi)和波形時限(xian)測量結(jie)果（ms）

注：A 型(xing)號為進口心電圖機，C、F 型(xing)號為國產心電圖機

 

表 6 抗噪聲測量穩定性結果（ms）

注：A 型(xing)號為進口心電圖機，C、F 型(xing)號為國產心電圖機

 

2.3  可(ke)靠(kao)性測試(shi)結果

 

相比(bi)彎(wan)曲(qu)壽命(ming)試(shi)驗(yan)前，A、B、C 和(he) F 型號在(zai)彎(wan)曲(qu)壽命(ming)試(shi)驗(yan)后(hou)最(zui)大阻值(zhi)變化依次為(wei)導(dao)(dao)聯(lian)線(xian) 13 mΩ、主(zhu)電(dian)(dian)纜(lan)(lan) 173 mΩ，導(dao)(dao)聯(lian)線(xian) 15 mΩ、主(zhu)電(dian)(dian)纜(lan)(lan) 11 mΩ，導(dao)(dao)聯(lian)線(xian) 11 mΩ、主(zhu)電(dian)(dian)纜(lan)(lan) 214 mΩ，導(dao)(dao)聯(lian)線(xian) 12 mΩ、導(dao)(dao)聯(lian)線(xian) 26 mΩ。另一項可(ke)靠性指標連(lian)(lian)接器插(cha)拔試(shi)驗(yan)后(hou)，各設備(bei)的每(mei)根(gen)患者(zhe)導(dao)(dao)聯(lian)線(xian)到電(dian)(dian)纜(lan)(lan)分(fen)線(xian)盒、每(mei)根(gen)主(zhu)電(dian)(dian)纜(lan)(lan)到設備(bei)插(cha)座的連(lian)(lian)接直流電(dian)(dian)阻均(jun)不超過(guo) 1.0 Ω。環境試(shi)驗(yan)結果(guo)見表 7。

 

表(biao) 7 可(ke)靠性（環境試驗）結果

注(zhu)：A 型號為進口心(xin)電(dian)圖機，B~F 型號為國產(chan)心(xin)電(dian)圖機

 

3.  討論

 

心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)靈(ling)敏(min)度(du)是確保心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)有效(xiao)(xiao)實(shi)現(xian)其預期用(yong)途的(de)(de)(de)(de)(de)(de)(de)(de)重要技術指(zhi)(zhi)標之一，如(ru)不(bu)(bu)(bu)(bu)(bu)符合要求或偏低，則表(biao)明(ming)設備無法較(jiao)好(hao)記(ji)錄(lu)、測(ce)量真實(shi)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)信(xin)號(hao)。本(ben)(ben)研(yan)究(jiu)(jiu)(jiu)結(jie)(jie)果(guo)顯(xian)(xian)示，除(chu)(chu)(chu)(chu)(chu)(chu)(chu) B 型(xing)號(hao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)，其余參(can)(can)評(ping)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)均(jun)達到(dao)或近似(si)達到(dao)參(can)(can)考(kao)(kao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)靈(ling)敏(min)度(du)精確度(du)或穩(wen)定(ding)性水平。由(you)于(yu)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)中(zhong)(zhong)(zhong)含有較(jiao)多(duo)低頻(pin)(pin)(pin)成分，所(suo)以低頻(pin)(pin)(pin)噪聲干(gan)擾所(suo)引起的(de)(de)(de)(de)(de)(de)(de)(de)基(ji)線漂移(yi)可能(neng)會(hui)(hui)影響(xiang)記(ji)錄(lu)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)波形(xing)(xing)(xing)及隨后的(de)(de)(de)(de)(de)(de)(de)(de)處理分析。本(ben)(ben)研(yan)究(jiu)(jiu)(jiu)結(jie)(jie)果(guo)顯(xian)(xian)示，參(can)(can)評(ping)的(de)(de)(de)(de)(de)(de)(de)(de) 5 臺(tai)國(guo)產樣(yang)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)相比進(jin)口樣(yang)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)有著類似(si)或更(geng)小(xiao)的(de)(de)(de)(de)(de)(de)(de)(de)基(ji)線漂移(yi)，且前者(zhe)(zhe)的(de)(de)(de)(de)(de)(de)(de)(de)基(ji)線穩(wen)定(ding)性也相對(dui)更(geng)好(hao)。另外，結(jie)(jie)合心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)記(ji)錄(lu)中(zhong)(zhong)(zhong)對(dui)幅度(du)為(wei) 3 mV、脈寬為(wei) 100 ms 的(de)(de)(de)(de)(de)(de)(de)(de)矩形(xing)(xing)(xing)脈沖相對(dui)等電(dian)(dian)(dian)(dian)位線的(de)(de)(de)(de)(de)(de)(de)(de)偏移(yi)及脈沖后斜率(lv)(lv)(lv) 2 個指(zhi)(zhi)標來看，F 型(xing)號(hao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)（偏移(yi)20 μV、斜率(lv)(lv)(lv) 1.0 μV/s）的(de)(de)(de)(de)(de)(de)(de)(de)表(biao)現(xian)基(ji)本(ben)(ben)并肩進(jin)口心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)（偏移(yi) 20 μV、斜率(lv)(lv)(lv) 0.8 μV/s），但 B ~ E 型(xing)號(hao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)低頻(pin)(pin)(pin)特性表(biao)現(xian)則弱于(yu)這兩者(zhe)(zhe)。頻(pin)(pin)(pin)率(lv)(lv)(lv)響(xiang)應(ying)指(zhi)(zhi)標可以反映心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)通頻(pin)(pin)(pin)帶(dai)，不(bu)(bu)(bu)(bu)(bu)同(tong)(tong)頻(pin)(pin)(pin)率(lv)(lv)(lv)響(xiang)應(ying)范(fan)圍下記(ji)錄(lu)到(dao)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)波形(xing)(xing)(xing)會(hui)(hui)有不(bu)(bu)(bu)(bu)(bu)同(tong)(tong)，失真有可能(neng)會(hui)(hui)影響(xiang)后續診療實(shi)施。本(ben)(ben)研(yan)究(jiu)(jiu)(jiu)結(jie)(jie)果(guo)顯(xian)(xian)示，B ~ F 型(xing)號(hao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)在(zai)(zai)低頻(pin)(pin)(pin) 0.01 Hz 和 0.05 Hz 頻(pin)(pin)(pin)率(lv)(lv)(lv)點的(de)(de)(de)(de)(de)(de)(de)(de)表(biao)現(xian)不(bu)(bu)(bu)(bu)(bu)如(ru)參(can)(can)考(kao)(kao)樣(yang)機(ji)(ji)(ji)(ji)(ji)(ji)(ji) A，但在(zai)(zai) 100 ~ 500 Hz 頻(pin)(pin)(pin)段，參(can)(can)評(ping) 5 臺(tai)國(guo)產心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)頻(pin)(pin)(pin)率(lv)(lv)(lv)響(xiang)應(ying)結(jie)(jie)果(guo)均(jun)優于(yu)參(can)(can)考(kao)(kao)樣(yang)機(ji)(ji)(ji)(ji)(ji)(ji)(ji) A，表(biao)明(ming)了(le)國(guo)產心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)高頻(pin)(pin)(pin)波形(xing)(xing)(xing)不(bu)(bu)(bu)(bu)(bu)易(yi)失真的(de)(de)(de)(de)(de)(de)(de)(de)特性。輸(shu)入(ru)阻(zu)(zu)抗(kang)(kang)是心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)前級(ji)放大(da)器的(de)(de)(de)(de)(de)(de)(de)(de)輸(shu)入(ru)阻(zu)(zu)抗(kang)(kang)。由(you)于(yu)皮膚 - 電(dian)(dian)(dian)(dian)極(ji)阻(zu)(zu)抗(kang)(kang)的(de)(de)(de)(de)(de)(de)(de)(de)存在(zai)(zai)，足夠(gou)(gou)高的(de)(de)(de)(de)(de)(de)(de)(de)輸(shu)入(ru)阻(zu)(zu)抗(kang)(kang)能(neng)保證(zheng)(zheng)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)采集到(dao)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)信(xin)號(hao)衰減較(jiao)小(xiao)，從而不(bu)(bu)(bu)(bu)(bu)會(hui)(hui)使記(ji)錄(lu)到(dao)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)波形(xing)(xing)(xing)明(ming)顯(xian)(xian)失真，所(suo)以此指(zhi)(zhi)標的(de)(de)(de)(de)(de)(de)(de)(de)要求主要是為(wei)了(le)測(ce)試(shi)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)在(zai)(zai)正常(chang)使用(yong)中(zhong)(zhong)(zhong)尤其是在(zai)(zai)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)信(xin)號(hao)有效(xiao)(xiao)頻(pin)(pin)(pin)率(lv)(lv)(lv)范(fan)圍內(nei)皮膚 - 電(dian)(dian)(dian)(dian)極(ji)阻(zu)(zu)抗(kang)(kang)對(dui)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)的(de)(de)(de)(de)(de)(de)(de)(de)影響(xiang)。本(ben)(ben)研(yan)究(jiu)(jiu)(jiu)結(jie)(jie)果(guo)顯(xian)(xian)示，100 Hz 時的(de)(de)(de)(de)(de)(de)(de)(de)輸(shu)入(ru)阻(zu)(zu)抗(kang)(kang)較(jiao)10 Hz 測(ce)試(shi)點的(de)(de)(de)(de)(de)(de)(de)(de)衰減更(geng)多(duo)，表(biao)明(ming)皮膚 - 電(dian)(dian)(dian)(dian)極(ji)阻(zu)(zu)抗(kang)(kang)對(dui)記(ji)錄(lu)到(dao)的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)波形(xing)(xing)(xing)中(zhong)(zhong)(zhong)高頻(pin)(pin)(pin)成分的(de)(de)(de)(de)(de)(de)(de)(de)影響(xiang)更(geng)大(da)。5 臺(tai)國(guo)產心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)此項指(zhi)(zhi)標的(de)(de)(de)(de)(de)(de)(de)(de)技術特征與參(can)(can)考(kao)(kao)樣(yang)機(ji)(ji)(ji)(ji)(ji)(ji)(ji) A 的(de)(de)(de)(de)(de)(de)(de)(de)差異(yi)(yi)不(bu)(bu)(bu)(bu)(bu)顯(xian)(xian)著。醫院等環境(jing)中(zhong)(zhong)(zhong)，心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)可能(neng)隨時用(yong)于(yu)患者(zhe)(zhe)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)。因而，除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)過載保護(hu)(hu)是所(suo)有心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)必需功能(neng)。除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)后的(de)(de)(de)(de)(de)(de)(de)(de)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)了(le)自身設備安全，還必須(xu)盡(jin)快(kuai)恢復(fu)至正常(chang)工作狀態，以便醫師能(neng)夠(gou)(gou)盡(jin)快(kuai)獲知除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)效(xiao)(xiao)果(guo)，盡(jin)快(kuai)采取較(jiao)佳診療方案(an)。同(tong)(tong)時，心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)也不(bu)(bu)(bu)(bu)(bu)應(ying)從患者(zhe)(zhe)分流過多(duo)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)能(neng)量，否則會(hui)(hui)導致(zhi)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)效(xiao)(xiao)能(neng)下降(jiang)，增加電(dian)(dian)(dian)(dian)極(ji)接觸點處的(de)(de)(de)(de)(de)(de)(de)(de)患者(zhe)(zhe)灼傷風險。本(ben)(ben)研(yan)究(jiu)(jiu)(jiu)結(jie)(jie)果(guo)顯(xian)(xian)示，B ~ D 型(xing)號(hao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)在(zai)(zai)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)后恢復(fu)的(de)(de)(de)(de)(de)(de)(de)(de)更(geng)快(kuai)；E 和 F 型(xing)號(hao)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)能(neng)量損(sun)失表(biao)現(xian)較(jiao)好(hao)，表(biao)明(ming)有更(geng)多(duo)能(neng)量用(yong)于(yu)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)，保證(zheng)(zheng)了(le)較(jiao)好(hao)的(de)(de)(de)(de)(de)(de)(de)(de)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)效(xiao)(xiao)果(guo)；在(zai)(zai)除(chu)(chu)(chu)(chu)(chu)(chu)(chu)顫(zhan)(zhan)過載保護(hu)(hu)指(zhi)(zhi)標的(de)(de)(de)(de)(de)(de)(de)(de)測(ce)試(shi)中(zhong)(zhong)(zhong)，參(can)(can)評(ping)國(guo)產心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)與參(can)(can)考(kao)(kao)心(xin)(xin)(xin)(xin)(xin)(xin)(xin)電(dian)(dian)(dian)(dian)圖(tu)(tu)(tu)(tu)(tu)(tu)(tu)機(ji)(ji)(ji)(ji)(ji)(ji)(ji)差異(yi)(yi)不(bu)(bu)(bu)(bu)(bu)明(ming)顯(xian)(xian)。

 

自動(dong)測(ce)(ce)(ce)量(liang)準確(que)(que)性(xing)(xing)(xing)是國際心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)標準化和(he)(he)定量(liang)化的(de)(de)重要指標。如(ru)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)宣稱能夠分(fen)析心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)、并從(cong)中得到自動(dong)測(ce)(ce)(ce)量(liang)結(jie)(jie)(jie)果(guo)，則主要從(cong)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)的(de)(de)幅度和(he)(he)間(jian)期兩方面(mian)(mian)衡(heng)量(liang)其自動(dong)測(ce)(ce)(ce)量(liang)性(xing)(xing)(xing)能的(de)(de)準確(que)(que)性(xing)(xing)(xing)。幅度測(ce)(ce)(ce)量(liang)準確(que)(que)性(xing)(xing)(xing)方面(mian)(mian)，以心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)對(dui) P、Q、R、S、ST、T 波的(de)(de)振(zhen)幅測(ce)(ce)(ce)量(liang)值(zhi)(zhi)(zhi)(zhi)結(jie)(jie)(jie)果(guo)，相對(dui)參(can)考值(zhi)(zhi)(zhi)(zhi)的(de)(de)偏(pian)離值(zhi)(zhi)(zhi)(zhi)來衡(heng)量(liang)。本研究結(jie)(jie)(jie)果(guo)顯(xian)示，在測(ce)(ce)(ce)試的(de)(de) CTS數據里，當參(can)考值(zhi)(zhi)(zhi)(zhi)振(zhen)幅值(zhi)(zhi)(zhi)(zhi)≤ 500 μV 時(shi)(shi)，C（偏(pian)離24.4 μV）和(he)(he) F 型(xing)號(hao)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)（偏(pian)離 19.2 μV）好于參(can)考樣(yang)機(ji)(ji) A（偏(pian)離 39.8 μV）；當參(can)考值(zhi)(zhi)(zhi)(zhi)振(zhen)幅值(zhi)(zhi)(zhi)(zhi) >500 μV 時(shi)(shi)，A、C 和(he)(he) F 型(xing)號(hao)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)偏(pian)離參(can)考值(zhi)(zhi)(zhi)(zhi)的(de)(de)百分(fen)比分(fen)別為 4.0%、4.1% 和(he)(he) 3.3%；振(zhen)幅測(ce)(ce)(ce)量(liang)的(de)(de)測(ce)(ce)(ce)試結(jie)(jie)(jie)果(guo)以 F 型(xing)號(hao)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)最好。此指標在國產型(xing)號(hao)與(yu)參(can)考型(xing)號(hao)之間(jian)的(de)(de)差(cha)異不顯(xian)著。間(jian)期測(ce)(ce)(ce)量(liang)準確(que)(que)性(xing)(xing)(xing)方面(mian)(mian)，除了 R 波時(shi)(shi)限，A 型(xing)號(hao)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)各項測(ce)(ce)(ce)量(liang)結(jie)(jie)(jie)果(guo)的(de)(de)平均(jun)(jun)誤(wu)差(cha)均(jun)(jun)較小(xiao)；測(ce)(ce)(ce)量(liang)結(jie)(jie)(jie)果(guo)的(de)(de)標準偏(pian)差(cha)則表(biao)現(xian)不一。參(can)考樣(yang)機(ji)(ji) A 對(dui)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)各波的(de)(de)絕對(dui)間(jian)期和(he)(he)波形(xing)時(shi)(shi)限自動(dong)測(ce)(ce)(ce)量(liang)的(de)(de)平均(jun)(jun)誤(wu)差(cha)相對(dui)較小(xiao)、結(jie)(jie)(jie)果(guo)相對(dui)更(geng)準確(que)(que)。抗(kang)噪(zao)聲(sheng)(sheng)測(ce)(ce)(ce)量(liang)穩定性(xing)(xing)(xing)方面(mian)(mian)，無(wu)論在無(wu)噪(zao)聲(sheng)(sheng)時(shi)(shi)還是在高頻(pin)噪(zao)聲(sheng)(sheng)、基線漂移、工頻(pin)干擾存(cun)在的(de)(de)情況下，C、F 型(xing)號(hao)心(xin)(xin)電(dian)(dian)圖(tu)(tu)(tu)機(ji)(ji)的(de)(de) P 波時(shi)(shi)限和(he)(he) QRS 時(shi)(shi)限平均(jun)(jun)誤(wu)差(cha)均(jun)(jun)優(you)于參(can)考樣(yang)機(ji)(ji) A，抗(kang)噪(zao)聲(sheng)(sheng)測(ce)(ce)(ce)量(liang)穩定性(xing)(xing)(xing)更(geng)好一些。

 

本(ben)研究結果(guo)顯示，參評(ping)國產心(xin)(xin)電(dian)圖機導聯線(xian)可靠(kao)性指標(biao)與(yu)參考心(xin)(xin)電(dian)圖機無明(ming)顯差(cha)異。環(huan)境(jing)試(shi)驗結果(guo)表(biao)明(ming)和基準(zhun)環(huan)境(jing)條件相比(bi)，A 和 C ~ E 型號心(xin)(xin)電(dian)圖機工作和貯存于其要求的(de)環(huan)境(jing)時，靈敏(min)度(du)(du)(du)精(jing)確(que)度(du)(du)(du)誤差(cha)無明(ming)顯變(bian)化，可靠(kao)性較(jiao)好(hao)；而 B 和 F 型號心(xin)(xin)電(dian)圖機的(de)靈敏(min)度(du)(du)(du)精(jing)確(que)度(du)(du)(du)可靠(kao)性均有所降低。環(huan)境(jing)沖(chong)擊在參評(ping)設備間的(de)區別并不很(hen)明(ming)顯。

 

4.  結語

 

心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)的(de)(de)(de)(de)性(xing)能(neng)特(te)征決(jue)定(ding)了其在(zai)(zai)臨(lin)床(chuang)應(ying)用中的(de)(de)(de)(de)有效(xiao)性(xing)，也(ye)會影響隨后的(de)(de)(de)(de)部(bu)分(fen)(fen)醫(yi)療決(jue)策或診斷(duan)。目前，不同心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)性(xing)能(neng)方(fang)面存(cun)在(zai)(zai)一(yi)定(ding)差異(yi)。本研究結果(guo)表明(ming)(ming)，雖然包括(kuo)環境(jing)沖(chong)擊等在(zai)(zai)內的(de)(de)(de)(de)大(da)部(bu)分(fen)(fen)指(zhi)標的(de)(de)(de)(de)測試結果(guo)在(zai)(zai)參(can)評國(guo)(guo)(guo)產心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)與(yu)參(can)考(kao)樣機(ji)(ji)間并(bing)無明(ming)(ming)顯差異(yi)，但(dan)確(que)(que)有少量指(zhi)標表現(xian)(xian)了不同程度(du)的(de)(de)(de)(de)差異(yi)。參(can)評國(guo)(guo)(guo)產樣機(ji)(ji)優于(yu)參(can)考(kao)樣機(ji)(ji)的(de)(de)(de)(de)指(zhi)標有高(gao)頻(pin)(pin)(pin)響應(ying)（100 ~ 500 Hz 段(duan)）、基(ji)線(xian)穩定(ding)性(xing)及(ji)抗噪(zao)聲(sheng)(sheng)自動(dong)測量穩定(ding)性(xing)。較好地高(gao)頻(pin)(pin)(pin)率響應(ying)使國(guo)(guo)(guo)產心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)可較為準(zhun)確(que)(que)地重(zhong)(zhong)現(xian)(xian) Q 波(bo)和 R 波(bo)波(bo)形等高(gao)頻(pin)(pin)(pin)部(bu)分(fen)(fen)的(de)(de)(de)(de)內部(bu)細節。國(guo)(guo)(guo)產心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)擁有相(xiang)對(dui)更穩定(ding)的(de)(de)(de)(de)波(bo)形基(ji)線(xian)、抗噪(zao)聲(sheng)(sheng)自動(dong)測量準(zhun)確(que)(que)性(xing)，也(ye)使其在(zai)(zai)醫(yi)療設備眾多、存(cun)在(zai)(zai)較大(da)干(gan)擾(rao)的(de)(de)(de)(de)復雜臨(lin)床(chuang)環境(jing)中表現(xian)(xian)更佳。但(dan)對(dui)于(yu)頻(pin)(pin)(pin)率響應(ying)低(di)頻(pin)(pin)(pin)段(duan)特(te)性(xing)及(ji)心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)對(dui)于(yu)心(xin)(xin)(xin)電(dian)(dian)圖(tu)各波(bo)絕對(dui)間期和波(bo)形時限測量的(de)(de)(de)(de)自動(dong)分(fen)(fen)析準(zhun)確(que)(que)性(xing)，參(can)評國(guo)(guo)(guo)產心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)與(yu)參(can)考(kao)樣機(ji)(ji)仍有一(yi)定(ding)差距。參(can)評的(de)(de)(de)(de)國(guo)(guo)(guo)產心(xin)(xin)(xin)電(dian)(dian)圖(tu)機(ji)(ji)所反映的(de)(de)(de)(de)低(di)頻(pin)(pin)(pin)響應(ying)特(te)性(xing)使其擁有更快的(de)(de)(de)(de)基(ji)線(xian)重(zhong)(zhong)現(xian)(xian)能(neng)力，這也(ye)與(yu)其在(zai)(zai)測試中表現(xian)(xian)出更好的(de)(de)(de)(de)基(ji)線(xian)穩定(ding)性(xing)結果(guo)相(xiang)一(yi)致。但(dan)另(ling)一(yi)方(fang)面，國(guo)(guo)(guo)產樣機(ji)(ji)在(zai)(zai)不失真的(de)(de)(de)(de)重(zhong)(zhong)現(xian)(xian) ST 波(bo)段(duan)（無論是(shi)水平還是(shi)斜坡方(fang)向）方(fang)面的(de)(de)(de)(de)能(neng)力可能(neng)稍顯遜色，或許會影響到(dao)如 ST 段(duan)壓低(di)、ST 段(duan)抬高(gao)及(ji)相(xiang)關(guan)心(xin)(xin)(xin)臟(zang)疾病的(de)(de)(de)(de)診斷(duan)。

 

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［7］全國醫用電(dian)器標(biao)準(zhun)化技術(shu)委員會醫用電(dian)子(zi)儀器標(biao)準(zhun)化分技術(shu)委員會 . YY0782-2010 醫用電(dian)氣設備第 2-51 部分：記錄和(he)(he)分析型單道(dao)和(he)(he)多道(dao)心(xin)電(dian)圖機安全和(he)(he)基本性能專用要求 [S]. 北京：中國標(biao)準(zhun)出版社，2010.

 

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［9］中(zhong)華人民(min)共(gong)和國(guo)國(guo)家(jia)質量(liang)監督(du)檢驗(yan)檢疫(yi)總局(ju)，中(zhong)國(guo)國(guo)家(jia)標準化管理委員會 . GB/T 14710-2009 醫用電器環境要(yao)求及試驗(yan)方(fang)法 [S]. 北京：中(zhong)國(guo)標準出版(ban)社，2009.

 

［10］國家食品藥品監督(du)管理局 . YY 0828-2011 心電監護儀電纜和導聯(lian)線 [S]. 北京(jing)：中國標準出(chu)版社，2011.

 

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