1、ECG测试方案讲课讲稿监护仪心电测试方案文档标识:当前版本:当前状态:发布日期:发布YY1079_ECG_test_011.0草稿修改历史完成日期版本作者修改内容2011-6-241.0谢剑南评审号变更控制号第一部分:文档介绍ECG的测试方案基于YY1079-2008标准生成。测试监护仪心电模块的步骤顺序也严格按照标准进行。为了使测试方案能够提高测试效率和更有针对性,本方案在标准的基础上结合本公司产品状况对某些测试项做了精简和删改。我们测试组的目的就是为了测试产品的性能,所以我们就省去非性能的测试项比如4.1.1的条目。从4.1.2.1开始一直到4.2.8.14是本测试方案的主体,其中主要介绍
2、各个项目的测试方法和大致的操作步骤,测试所需的环境和实验仪器。第二部分:备注信息术语与缩写解释:纵横比:显示器的纵向灵敏度(mm/mV)与横向灵敏度(mm/s)的比值。辅助输出:用于ECG信号显示、放大或处理的,提供电气连接到设备电路上的可触及的连接器或端子。(我公司监护仪暂未设置此类接口)带限响应:限制在某一带宽内的信号或放大器的响应。通道:记录系统的一部分,它由成比例宽度记录体和相关导联放大器组成。共模抑制:差分放大器抑制共模电压的能力。共模电压:不期望有但实际加在差分放大器两个输入端的具有相同幅度和相位的电压。直接记录设备:提供心电图是可视、永久记录的设备。滞后:直接记录仪输出描记的失能
3、。当从一侧或另一侧接近该位置时,对相同的输入电压得不到相同位置。输入电路:电路包括,例如,放大器输入部分,加权网络,保护网络,高频滤波器和患者电缆。输入阻抗:加载到放大器输入端的任意频率信号的电压与电流之比。非永久显示:类似在示波器上显示的非永久保留的显示。过冲:当阶跃电压施加到输入导联时,心电图输出描记线跃出(正向或负向)最终稳态偏转的部分。永久显示:显示在媒质上,例如纸张上的波形或文字,能够长期保留和归档并且能够直接读取和了解。儿科监护仪:专门用于新生儿和不超过8岁儿童的心电监护仪。与成年人相比.新生儿和婴幼儿的心电幅度长节律范围是不同的;这种差异随着年龄的增长逐渐消失。测试所需仪器设备:
4、 IBUSS,通用测试电路(后文若无特别说明默认与IBUSS配套使用),万用表,游标卡尺,共模抑制比测试工装,电外科干扰测试工装,秒表。测试场所的环境要求: 能够有效屏蔽外界工频干扰的的封闭房间。第三部分:性能测试项目1、4.1.2.1 (c) 高大T波的抑制能力需要的设备:IBUSS,游标卡尺目的:测试监护仪对于心电信号中的T波的分辨能力以及对于心率显示的影响。 方法:使用IBUSS给监护仪加载幅度为1mV,宽度为100ms,重复率为80bpm的QRS波,T波初始值为0mV。在试验之前应允许监护仪有20s的稳定期,将T波的的幅度每隔一分钟增加0.2mV,直到1.2mV。增加的过程持续到心率显
5、示值超过允许的10误差或者直到得不到稳定的心率指示时,记录当先T波的幅值,当前的T波大小则为监护仪的抑制能力。2、4.1.2.1 (e) 心率计准确度和对心率不齐的响应需要的设备:IBUSS目的:分别通过输入二联律波形,缓变二联律波形,快二联律,双向收缩四种波形检验监护仪对于以上四种波形的心率识别程度。方法:保持监护仪20s稳定时间,然后使用IBUSS分别输入以上四种波形给监护仪分别记录四种波形情况下显示的心率值。二联律如果计算所有QRS波群,心率为80bpm,如果计算较大的R波或S波心率为40bpm。缓变二联律如果计算所有QRS波群,心率为60bpm,如果仅计算较大的波心率为30bpm。快变
6、二联律计算所有QRS波群,心率为120bpm。双向收缩如果计算所有QRS波群,心率为90bpm,如果仅计算较大的波,心率为45bpm。 3、4.1.2.1 (f) 心率计对心率变化的响应时间需要的设备:IBUSS,秒表目的:测试心率从80bpm一步增加至120bpm以及80bpm一步减少至40bpm时设备指示新心率所需的最大响应时间,并且结果精确到秒。方法:将IBUSS与监护仪正确连接后,使用IBUSS输出相对应的波形信号。对心率增加,响应时间是从新心率第一个QRS波开始,到心率计显示值第一次增加到或超过80bpm时心率指示的37加上120bpm时稳态指示的63的值为止。对心率减少,响应时间是
7、从新心率的第一个QRS波开始,到心率计算显示第一次减少到或低于80bpm的37%加上40bpm时稳态指示的63%的值为止的时间。测试多次结束后取最大值并记录到测试用例上。4、4.1.2.1 (g) 心动过速报警的启动时间需要的设备:IBUSS,秒表,游标卡尺目的:通过使用IBUSS输出一组三角波信号给监护仪,测试当正常三角波信号的重复率突变导致触发监护仪的报警时所需的时间,以及这些波形的幅度降为正常波形的一半或者两倍时所需的报警时间。方法:设置监护仪的报警限,上限为100bpm,下限为60bpm,设置监护仪的波形增益为1倍。选择IBUSS上面相对应的测试项,首先输出一个幅度为1mV宽度为100
8、ms重复率为80bpm的QRS波,IBUSS会持续输出此波形30s,而后波形将突变为幅度为1mV,心率为206bpm的QRS波。测量当信号由正常心电信号突变为室速信号时报警被激活之间的时间间隔,记为t1。重复测试五次,时间间隔分别记为t1,t2,t3,t4,t5,求得平均值为T=( t1+t2+t3+t4+t5)/5。当测试完以上波形时,将30s突变后的波形幅值改为0.5mV重新测试五次并计算平均值。设置监护仪的波形增益为0.5倍。30s突变后的波形幅值改为2mV重复率为206bpm重复试验五次并求得平均值。30s突变后的波形幅值改为2mV重复率为195bpm时重复测量五次并求得平均值。30s
9、突变后的波形幅值改为1mV重复率为195bpm时重复测量五次并求得平均值。30s突变后的波形幅值改为4mV重复率为195bpm时重复测量五次并求得平均值。5、4.1.4.2有过冲起搏器脉冲抑制需要的设备:IBUSS,秒表目的:测试当输入具有从2mV到700mV幅度的P波以及0.1ms到2ms脉宽的起搏脉冲的波形给监护仪时,监护仪对于以上情况下的波形的心率显示值。方法(A):连接好IBUSS与监护仪的到连线,并选择IBUSS上相对应的测试方案。首先使用IBUSS输出合成心电波信号给监护仪,记录稳定时显示的心率值。由于本项目测试步骤繁多,表一将列出本次测试所需波形的组合情况: 步骤波形(幅值,宽度
10、,重复率,延时1,延时2)1起搏脉冲(2mV,50ms,60bpm,960ms)过冲(-0.2mV,50ms,60bpm,960ms)合成心电波(60bpm) 2起搏脉冲(2mV,50ms,60bpm,960ms)过冲(-0.2mV,50ms,60bpm,960ms)3起搏脉冲(-2mV,50ms,60bpm,960ms)过冲(0.2mV,50ms,60bpm,960ms)合成心电波(60bpm)4起搏脉冲(-2mV,50ms,60bpm,960ms)过冲(0.2mV,50ms,60bpm,960ms)5起搏脉冲(700mV,50ms,60bpm,960ms)过冲(-2mV,50ms,60bp
11、m,960ms)合成心电波(60bpm)6起搏脉冲(700mV,50ms,60bpm,960ms)过冲(-2mV,50ms,60bpm,960ms)7起搏脉冲(-700mV,50ms,60bpm,960ms)过冲(2mV,50ms,60bpm,960ms)合成心电波(60bpm)8起搏脉冲(-700mV,50ms,60bpm,960ms)过冲(2mV,50ms,60bpm,960ms)9起搏脉冲(2mV,50ms,80bpm)过冲(-0.2mV,50ms,80bpm)合成心电波(30bpm)10起搏脉冲(2mV,50ms,80bpm,0ms)过冲(-0.2mV,50ms,80bpm,0ms)1
12、1起搏脉冲(-2mV,50ms,80bpm,0ms)过冲(0.2mV,50ms,80bpm,0ms)合成心电波(30bpm)12起搏脉冲(-2mV,50ms,80bpm,0ms)过冲(0.2mV,50ms,80bpm,0ms)13起搏脉冲(700mV,50ms,80bpm,0ms)过冲(-2mV,50ms,80bpm,0ms)合成心电波(30bpm)14起搏脉冲(700mV,50ms,80bpm,0ms)过冲(-2mV,50ms,80bpm,0ms)15起搏脉冲(-700mV,50ms,80bpm,0ms)过冲(2mV,50ms,80bpm,0ms)合成心电波(30bpm)16起搏脉冲(-70
13、0mV,50ms,80bpm,0ms)过冲(2mV,50ms,80bpm,0ms)17起搏脉冲x2(2mV,50ms,60bpm,960ms,810ms)过冲x2(-0.2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)18起搏脉冲x2(2mV,50ms,60bpm,960ms,810ms)过冲x2(-0.2mV,50ms,60bpm,960ms,810ms)19起搏脉冲x2(-2mV,50ms,60bpm,960ms,810ms)过冲x2(0.2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)20起搏脉冲x2(-2mV,50ms,60b
14、pm,960ms,810ms)过冲x2(0.2mV,50ms,60bpm,960ms,810ms)21起搏脉冲x2(700mV,50ms,60bpm,960ms,810ms)过冲x2(-2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)22起搏脉冲x2(700mV,50ms,60bpm,960ms,810ms)过冲x2(-2mV,50ms,60bpm,960ms,810ms)23起搏脉冲x2(-700mV,50ms,60bpm,960ms,810ms)过冲x2(2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)24起搏脉冲x2(-700m
15、V,50ms,60bpm,960ms,810ms)过冲x2(2mV,50ms,60bpm,960ms,810ms)25起搏脉冲x2(2mV,50ms,80bpm,560ms,410ms)过冲x2(-0.2mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)26起搏脉冲x2(2mV,50ms,80bpm,560ms,410ms)过冲x2(-0.2mV,50ms,80bpm,560ms,410ms)27起搏脉冲x2(-2mV,50ms,80bpm,560ms,410ms)过冲x2(0.2mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)28起搏脉冲
16、x2(-2mV,50ms,80bpm,560ms,410ms)过冲x2(0.2mV,50ms,80bpm,560ms,410ms)29起搏脉冲x2(700mV,50ms,80bpm,560ms,410ms)过冲x2(-2mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)30起搏脉冲x2(700mV,50ms,80bpm,560ms,410ms)过冲x2(-2mV,50ms,80bpm,560ms,410ms)31起搏脉冲x2(-700mV,50ms,80bpm,560ms,410ms)过冲x2(2mV,50ms,80bpm,560ms,410ms)合成心电波(30bp
17、m)32起搏脉冲x2(-700mV,50ms,80bpm,560ms,410ms)过冲x2(2mV,50ms,80bpm,560ms,410ms)33起搏脉冲x2(2mV,50ms,60bpm,960ms,710ms)过冲x2(-0.2mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)34起搏脉冲x2(2mV,50ms,60bpm,960ms,710ms)过冲x2(-0.2mV,50ms,60bpm,960ms,710ms)35起搏脉冲x2(-2mV,50ms,60bpm,960ms,710ms)过冲x2(0.2mV,50ms,60bpm,960ms,710ms)合成
18、心电波(60bpm)36起搏脉冲x2(-2mV,50ms,60bpm,960ms,710ms)过冲x2(0.2mV,50ms,60bpm,960ms,710ms)37起搏脉冲x2(700mV,50ms,60bpm,960ms,710ms)过冲x2(-2mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)38起搏脉冲x2(700mV,50ms,60bpm,960ms,710ms)过冲x2(-2mV,50ms,60bpm,960ms,710ms)39起搏脉冲x2(-700mV,50ms,60bpm,960ms,710ms)过冲x2(2mV,50ms,60bpm,960ms,
19、710ms)合成心电波(60bpm)40起搏脉冲x2(-700mV,50ms,60bpm,960ms,710ms)过冲x2(2mV,50ms,60bpm,960ms,710ms)41起搏脉冲x2(2mV,50ms,60bpm,560ms,310ms)过冲x2(-0.2mV,50ms,60bpm,560ms,310ms)合成心电波(60bpm)42起搏脉冲x2(2mV,50ms,60bpm,560ms,310ms)过冲x2(-0.2mV,50ms,60bpm,560ms,310ms)43起搏脉冲x2(-2mV,50ms,80bpm,560ms,310ms)过冲x2(0.2mV,50ms,80bp
20、m,560ms,310ms)合成心电波(30bpm)44起搏脉冲x2(-2mV,50ms,80bpm,560ms,310ms)过冲x2(0.2mV,50ms,80bpm,560ms,310ms)45起搏脉冲x2(700mV,50ms,80bpm,560ms,310ms)过冲x2(-2mV,50ms,80bpm,560ms,310ms)合成心电波(30bpm)46起搏脉冲x2(700mV,50ms,80bpm,560ms,310ms)过冲x2(-2mV,50ms,80bpm,560ms,310ms)47起搏脉冲x2(-700mV,50ms,80bpm,560ms,310ms)过冲x2(2mV,5
21、0ms,80bpm,560ms,310ms)合成心电波(30bpm)48起搏脉冲x2(-700mV,50ms,80bpm,560ms,310ms)过冲x2(2mV,50ms,80bpm,560ms,310ms)表一方法(B):连接好IBUSS与监护仪的到连线,并选择IBUSS上相对应的测试方案。首先使用IBUSS输出合成心电波信号给监护仪,记录稳定时显示的心率值。由于本项目测试步骤繁多,表二将列出本次测试所需波形的组合情况:步骤波形(幅值,宽度,重复率,延时1,延时2)1起搏脉冲(2mV,50ms,60bpm,960ms)过冲(-0.08mV,50ms,60bpm,960ms)合成心电波(60
22、bpm) 2起搏脉冲(2mV,50ms,60bpm,960ms)过冲(-0.08mV,50ms,60bpm,960ms)3起搏脉冲(-2mV,50ms,60bpm,960ms)过冲(0.08mV,50ms,60bpm,960ms)合成心电波(60bpm)4起搏脉冲(-2mV,50ms,60bpm,960ms)过冲(0.08mV,50ms,60bpm,960ms)5起搏脉冲(700mV,50ms,60bpm,960ms)过冲(-2mV,50ms,60bpm,960ms)合成心电波(60bpm)6起搏脉冲(700mV,50ms,60bpm,960ms)过冲(-2mV,50ms,60bpm,960m
23、s)7起搏脉冲(-700mV,50ms,60bpm,960ms)过冲(2mV,50ms,60bpm,960ms)合成心电波(60bpm)8起搏脉冲(-700mV,50ms,60bpm,960ms)过冲(2mV,50ms,60bpm,960ms)9起搏脉冲(2mV,50ms,80bpm)过冲(-0.08mV,50ms,80bpm)合成心电波(30bpm)10起搏脉冲(2mV,50ms,80bpm,0ms)过冲(-0.08mV,50ms,80bpm,0ms)11起搏脉冲(-2mV,50ms,80bpm,0ms)过冲(0.08mV,50ms,80bpm,0ms)合成心电波(30bpm)12起搏脉冲(
24、-2mV,50ms,80bpm,0ms)过冲(0.08mV,50ms,80bpm,0ms)13起搏脉冲(700mV,50ms,80bpm,0ms)过冲(-2mV,50ms,80bpm,0ms)合成心电波(30bpm)14起搏脉冲(700mV,50ms,80bpm,0ms)过冲(-2mV,50ms,80bpm,0ms)15起搏脉冲(-700mV,50ms,80bpm,0ms)过冲(2mV,50ms,80bpm,0ms)合成心电波(30bpm)16起搏脉冲(-700mV,50ms,80bpm,0ms)过冲(2mV,50ms,80bpm,0ms)17起搏脉冲x2(2mV,50ms,60bpm,960
25、ms,810ms)过冲x2(-0.08mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)18起搏脉冲x2(2mV,50ms,60bpm,960ms,810ms)过冲x2(-0.08mV,50ms,60bpm,960ms,810ms)19起搏脉冲x2(-2mV,50ms,60bpm,960ms,810ms)过冲x2(0.08mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)20起搏脉冲x2(-2mV,50ms,60bpm,960ms,810ms)过冲x2(0.2mV,50ms,60bpm,960ms,810ms)21起搏脉冲x2(700mV,5
26、0ms,60bpm,960ms,810ms)过冲x2(-2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)22起搏脉冲x2(700mV,50ms,60bpm,960ms,810ms)过冲x2(-2mV,50ms,60bpm,960ms,810ms)23起搏脉冲x2(-700mV,50ms,60bpm,960ms,810ms)过冲x2(2mV,50ms,60bpm,960ms,810ms)合成心电波(60bpm)24起搏脉冲x2(-700mV,50ms,60bpm,960ms,810ms)过冲x2(2mV,50ms,60bpm,960ms,810ms)25起搏脉冲x2
27、(2mV,50ms,80bpm,560ms,410ms)过冲x2(-0.08mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)26起搏脉冲x2(2mV,50ms,80bpm,560ms,410ms)过冲x2(-0.08mV,50ms,80bpm,560ms,410ms)27起搏脉冲x2(-2mV,50ms,80bpm,560ms,410ms)过冲x2(0.08mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)28起搏脉冲x2(-2mV,50ms,80bpm,560ms,410ms)过冲x2(0.08mV,50ms,80bpm,560ms,41
28、0ms)29起搏脉冲x2(700mV,50ms,80bpm,560ms,410ms)过冲x2(-2mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)30起搏脉冲x2(700mV,50ms,80bpm,560ms,410ms)过冲x2(-2mV,50ms,80bpm,560ms,410ms)31起搏脉冲x2(-700mV,50ms,80bpm,560ms,410ms)过冲x2(2mV,50ms,80bpm,560ms,410ms)合成心电波(30bpm)32起搏脉冲x2(-700mV,50ms,80bpm,560ms,410ms)过冲x2(2mV,50ms,80bpm,
29、560ms,410ms)33起搏脉冲x2(2mV,50ms,60bpm,960ms,710ms)过冲x2(-0.08mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)34起搏脉冲x2(2mV,50ms,60bpm,960ms,710ms)过冲x2(-0.08mV,50ms,60bpm,960ms,710ms)35起搏脉冲x2(-2mV,50ms,60bpm,960ms,710ms)过冲x2(0.08mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)36起搏脉冲x2(-2mV,50ms,60bpm,960ms,710ms)过冲x2(0.08mV
30、,50ms,60bpm,960ms,710ms)37起搏脉冲x2(700mV,50ms,60bpm,960ms,710ms)过冲x2(-2mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)38起搏脉冲x2(700mV,50ms,60bpm,960ms,710ms)过冲x2(-2mV,50ms,60bpm,960ms,710ms)39起搏脉冲x2(-700mV,50ms,60bpm,960ms,710ms)过冲x2(2mV,50ms,60bpm,960ms,710ms)合成心电波(60bpm)40起搏脉冲x2(-700mV,50ms,60bpm,960ms,710ms)
31、过冲x2(2mV,50ms,60bpm,960ms,710ms)41起搏脉冲x2(2mV,50ms,60bpm,560ms,310ms)过冲x2(-0.08mV,50ms,60bpm,560ms,310ms)合成心电波(60bpm)42起搏脉冲x2(2mV,50ms,60bpm,560ms,310ms)过冲x2(-0.08mV,50ms,60bpm,560ms,310ms)43起搏脉冲x2(-2mV,50ms,80bpm,560ms,310ms)过冲x2(0.08mV,50ms,80bpm,560ms,310ms)合成心电波(30bpm)44起搏脉冲x2(-2mV,50ms,80bpm,560ms,310ms)过冲x2(0.08mV,50ms,80bpm,560ms,310ms)45起搏脉冲x2(700mV,50ms,80bpm,560ms,310ms)过冲x2(-2mV,50ms,80bpm,560ms,310ms)合成心电波
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