高频呼吸机校准规范试验报告.docx

附件4试验报告高频呼吸机校准规范编写组2023年10月一、试验目的验证高频呼吸机校准规范(征求意见稿)的可行性与适用性。二、试验地点上海德尔格医疗器械有限公司设备技术部，湖南省儿童医院新生儿科，湖南省人民医院新生儿科，湖南省妇幼保健院新生儿科，长沙市妇幼保健院新生儿科三、环境条件试验过程中，环境温度控制在(2025),相对湿度不超过85%四、试验标准及其他设备呼吸机质量检测仪、模拟肺五、试验对象序号生产厂家型号产品编号试验地点1号机DragerInfinity-C5OOASBD-0001上海德尔格设备技术部2号机DragerBabylog8000plusASCE-0030长沙市妇幼保健院新生儿科3号机StephanSophieS0381500984湖南省儿童医院新生儿科4号机StephanSophieS03819001759湖南省人民医院新生儿科5号机StephanSophieS03816001105湖南省妇幼保健院新生儿科6号机StephanChristinaS0390800628长沙市妇幼保健院新生儿科注:高频呼吸机实际生产在售在用的的厂家品牌较少,德尔格(Drager)和史蒂芬(StePhan)基本占据95%以上的市场，因此本试验报告覆盖这两个厂家的主流型号，分别在不同使用地点进行试验，取得各个参数的试验结果以期验证本规范的可行性与适用性。六、试验结果序号生产厂家型号产品编号试验地点1号机DragerIn11nity-C500ASBD-0001上海德尔格设备技术部校准项目技术要求校准结果设定值监测值平均值测量值平均值示值误差潮气量(mL)±15%/1515151514141414/62626262616161611.6%/1491491491491471471471471.4%通气频率（次Zmin）±1次/分或设定值的±10%（取绝对值大者）606060606060.360.360.360.3-0.5%100100100100100100.8100.8100.8100.8-0.8%150150150150150150.0150.0151.9150.6-0.4%300300300300300300307.7300302.6-0.9%600600600600600600600615.4605.1-0.8%900900900900900900923.1900907.7-0.8%气道峰压（mbar）±（2%FS+4%X实际读数）FS=80mbar1010.010.010.010.09.99.99.99.90.12020.020.020.020.019.819.819.819.80.23030.030.030.030.029.429.429.429.40.6呼气末正压（mbar）±（2%FS+4%X实际读数）FS=35mbar11.21.21.21.21.11.11.11.10.122.12.12.12.12.02.02.02.00.155.05.05.05.04.94.94.94.90.1吸气氧浓度（%）±5%（体积分数）212121212119.519.919.919.91.1404040404038.538.538.638.51.5606060606058.658.758.758.71.3序号生产厂家型号产品编号试验地点2号机DragerBabylog8000plusASCE-0030长沙市妇幼保健院新生儿科校准项目技术要求校准结果设定值监测值平均值测量值平均值示值误差潮气量（mL）±15%/1313131312121212/65656565626261624.8%/1531521521521441461451454.8%通气频率（次Zmin）±1次/分或设定值的±10%（取绝对值大者）606060606060.360.360.360.3-0.5%100100100100100100.8100.8100.8100.8-0.8%150150150150150151.9151.9151.9151.9-1.3%300300300300300300.0307.7307.7305.1-1.7%600600600600600615.4615.4615.4615.4-2.5%900900900900900923.1923.1923.1923.1-2.5%气道峰压±（2%FS+4%1010.010.010.010.09.79.79.79.70.3(mbar)X实际读数）FS=80mbar2020.020.020.020.019.619.619.619.60.43030.030.030.030.029.329.329.329.30.7呼气末正压（mbar）±(2%FS+4%X实际读数)FS=25mbar11.41.41.41.41.21.21.21.20.222.22.22.22.22.02.02.02.00.255.35.35.35.35.05.05.05.00.3吸气氧浓度（）±5%（体积分数）212121212118.918.919.018.92.1404040404037.537.537.637.52.5606060606057.457.357.357.32.7序号生产厂家型号产品编号试验地点3号机StephanSophieS0381500984湖南省儿童医院新生儿科校准项目技术要求校准结果设定值监测值平均值测量值平均值示值误差潮气量（mL）±15%/1515151514141414/61616161565656568.9%/1551561561561471471481476.1%通气频率（次Zmin）±1次份或设定值的±10%（取绝对值大者）606060606060.060.360.360.2-0.3%I(X)l1100I(X)100.0100.0100.0100.00.0%150150150150150150.0151.9150.0150.6-0.4%300300300300300307.7300.0307.7305.1-1.7%6006006006600600.0600.0600.06(X).00.0%900900900900900900.0923.1923.1915.4-1.7%气道峰压（CmH2O）±(2%FS+4%X实际读数)FS=60CmH2。1010.010.010.010.09.79.79.79.70.32020.020.020.020.019.819.819.819.80.23030.030.030.030.029.629.629.629.60.4呼气末正压（cmH2O）±(2%FS+4%X实际读数)FS=30cmHzO11.01.01.01.00.90.90.90.90.122.02.02.02.01.71.71.71.70.355.05.05.05.04.74.74.74.70.3吸气氧浓度（）±5%（体积分数）212121212120.120.120.120.10.9404040404038.938.938.938.91.1606060606058.858.858.858.81.2序号生产厂家型号产品编号试验地点4号机StephanSophieS03819001759湖南省人民医院新生儿科校准项目技术要求校准结果设定值监测值平均值测量值平均值示值误差潮气量(mL)±15%/1414141414131313/64646464626261623.2%/1571571561571511511521514.0%通气频率(次Zmin)±1次/分或设定值的±10%(取绝对值大者)606060606060.060.060.360.1-0.2%100100100100100100.0100.8100.0100.3-0.8%150150150150150150.0151.9150.0150.6-0.4%3003003003300307.7300.0300.()302.6-0.9%600