摘要
目的:制定输血输液加压仪和加温仪质量控制校准方案,以提升产品质量,保障医疗安全。方法:调研输血输液加压仪和加温仪现状及主要指标参数,制定输血输液加压仪和加温仪主要温度参数和压力参数检测方案,对6台输血输液加温仪和3台输血输液加压仪进行温度参数与压力参数质量控制检测。结果:输血输液加压仪和加温仪质量控制校准方案主要温度参数包括温度偏差和温度波动度,主要压力参数包括输出速度、放气速度、示值误差、控制稳定性、回程误差和气密性。输血输液加温仪设定检测温度为37℃和39℃时,温度检测上偏差为0~0.4℃,下偏差为0.1~0.7℃,37℃时温度波动最大值为0.3℃,39℃时温度波动最大值为0.4℃,温度检测均在合格范围之内;输血输液加压仪在50 mmHg、100 mmHg、200 mmHg、250 mmHg、300 mmHg压力时,检测最大示值误差为1.2~2.3 mmHg,最大回程误差为6~8 mmHg,控制稳定性最大值为3.3~4.15 mmHg,压力检测均在合格范围之内。结论:输血输液加压仪和加温仪质量控制方案能够确保该类设备性能安全与有效,降低临床使用风险。
Objective:To develop a quality control calibration plan for blood transfusion and infusion heating(pressurization)equipment to ensure medical safety.Methods:The current status and main index parameters of blood transfusion and infusion heating(pressurization)equipment were investigated,develop a detection plan for the main temperature and pressure parameters of the equipment was formulated.The quality control inspection for temperature and pressure parameters was conducted on 6 sets of blood transfusion and infusion heating equipment and 3 sets of blood transfusion and infusion pressurization equipment.Results:The main temperature parameters of the equipment quality control calibration plan included temperature deviation and temperature fluctuation,and the main pressure parameters included output speed,outgassing velocity,indication error,control stability,return error and air tightness.When the detection temperature of the transfusion and infusion heating equipment was set at 37℃and 39℃,the upper deviation of temperature detection was 0-0.4℃,and the lower deviation was 0.1-0.7℃,the maximum temperature fluctuation was 0.3℃at 37℃,and the maximum temperature fluctuation was 0.4℃at 39℃,and the temperature detection was all within the qualified range.When the pressure of the blood transfusion infusion was 50,100,200,250,and 300 mmHg,the maximum indication error was 1.2-2.3 mmHg,the maximum return error was 6-8 mmHg,and the maximum control stability value was 3.3-4.15 mmHg,and the pressure detection was within the qualified range.Conclusion:The quality control plan for blood transfusion and infusion heating(pressurization)equipment can ensure the safety and effectiveness of such equipment and reduce the risk of clinical use.
作者
黄靖
段傲文
李卫
杨利
魏安海
龙恒宇
张和华
徐力
曹珍珍
HUANG Jing;DUAN Ao-wen;LI Wei(不详;Department of Medical Engineering,Daping Hospital,Army Medical University,Chongqing 400042,China)
出处
《中国医学装备》
2023年第9期135-139,共5页
China Medical Equipment
基金
重庆市社会事业与民生保障科技创新专项(cstc2017shmsA130074)“基于物联网的重症监护室设备报警管理系统研究与应用示范”
重庆市技术预见与制度创新项目(CSTB2022TFII-0FX0040)“重庆市消化内镜产业与人工智能精准诊疗融合发展技术创新路线研究”。
关键词
加压仪
加温仪
医疗设备
质量控制
Pressurization equipment
Heating equipment
Medical equipment
Quality control[First-author’s address]
