达芬奇Si手术机器人系统的质量控制
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摘要
目的达芬奇Si(Da Vinci Si)手术机器人系统是目前全世界最先进的微创外科手术平台。该系统整合了三维立体高分辨率的影像技术和可转腕手术器械以及直觉同步操控技术,使复杂外科手术能以微创方式开展,因为其质量和精度关系到患者的生命安全,所以该系统的质量控制非常重要。方法以93/42/EEC Medical Devices Directive标准及厂家标准为依据,对机器人设备的电气安全、稳定性和精确性、视频及信息通讯等方面进行质量控制。结果通过质量控制,保障了设备正常运行和设备的精度,保证了患者的安全。结论严格按照质量控制标准定期对机器人进行检测和保养,可以提前发现问题,防止手术过程中出现机器人操控性差,图像不清晰以及通讯信号不稳定等情况,从而保证手术成功率。
Objective The Da Vinci Si surgical system is the most advanced platform for minimally invasive surgery available in the world nowadays. The integration of the high-resolution 3D vision, the wristed instrumentation, and the intuitive motion control enables the Da Vinci surgery do not to be limited by conventional surgical technologies. The system also provides a minimally invasive approach to a broad range of complex surgical procedures. High precision and quality is essential for the success of the surgery and the outcome of operation. Thus quality control and maintenance is very important in the system. Methods Emphasis was placed on the quality control of the Da Vinci Si robotic surgical system based on the Medical Device Directive, 93/42/EEC and manufacturer's standard. The components of quality control includes the electrical safety, the stability and accuracy,and the visual and information communication. Results The precision and function of the Da Vinci Si robotic surgical system, as well as patients' safety, were ensured through quality control. Conclusion It is important to check the system strictly based on the quality control standard and to maintain the system regularly to find out potential defective parts. It is essential to avoid non-intuitive control, blurred images, and instability of communication signals of the robotic system to ensure the safety and success of the surgery.
Objective The Da Vinci Si surgical system is the most advanced platform for minimally invasive surgery available in the world nowadays. The integration of the high-resolution 3D vision, the wristed instrumentation, and the intuitive motion control enables the Da Vinci surgery do not to be limited by conventional surgical technologies. The system also provides a minimally invasive approach to a broad range of complex surgical procedures. High precision and quality is essential for the success of the surgery and the outcome of operation. Thus quality control and maintenance is very important in the system. Methods Emphasis was placed on the quality control of the Da Vinci Si robotic surgical system based on the Medical Device Directive, 93/42/EEC and manufacturer's standard. The components of quality control includes the electrical safety, the stability and accuracy,and the visual and information communication. Results The precision and function of the Da Vinci Si robotic surgical system, as well as patients' safety, were ensured through quality control. Conclusion It is important to check the system strictly based on the quality control standard and to maintain the system regularly to find out potential defective parts. It is essential to avoid non-intuitive control, blurred images, and instability of communication signals of the robotic system to ensure the safety and success of the surgery.
引文
[1]杜志江.达芬奇手术机器人系统技术分析[J].机器人技术与应用,2011,(4):14-16.
[2]F.Pugin,P.Bucher,P.Morel.History of robotic surgery:da Vinci®[J].Journal of Visceral Surgery,2011,148(5):e3–e8.
[3]杜祥民,张永寿.达芬奇手术机器人系统介绍及应用进展[J].中国医学装备,2011,8(5):60-63.
[4]微创外科手术机器人—Da Vinci S手术系统[J].微创医学,2010,(5):433-434.
[5]R.Kumar,N.Shrivastava,A.Seth,et al.Device malfunction with the da Vinci S®surgical system and its impact on surgical procedures[J].European Urology Supplements,2015,14(2):e873.
[6]Borden LS Jr,Kozlowski PM,Porter CR,et al.Mechanical failure rate of da Vinci robotic system[J].The Canadian Journal of Urology,2007,14(2):3499-3501.
[7]陈广飞,周丹,张茜.达芬奇手术机器人系统在医疗中的应用[J].机器人技术与应用,2011,(4):11-13.
[8]Won Tae Kim,Won Sik Ham,Wooju Jeong,et al.Failure and Malfunction of da Vinci Surgical Systems During Various Robotic Surgeries:Experience From Six Departments at a Single Institute[J].Urology,2009,74(6):1234-1237.
[9]Nicolas C.Buchs,Fran?ois Pugin,Francesco Volonté,et al.Reliability of robotic system during general surgical procedures in a university hospital[J].The American Journal of Surgery,2014,207(1):84-88.
[10]李澍,李佳戈,苏宗文.医疗器械电磁兼标准解析[J].中国医疗设备,2014,29(2):14-17.
[2]F.Pugin,P.Bucher,P.Morel.History of robotic surgery:da Vinci®[J].Journal of Visceral Surgery,2011,148(5):e3–e8.
[3]杜祥民,张永寿.达芬奇手术机器人系统介绍及应用进展[J].中国医学装备,2011,8(5):60-63.
[4]微创外科手术机器人—Da Vinci S手术系统[J].微创医学,2010,(5):433-434.
[5]R.Kumar,N.Shrivastava,A.Seth,et al.Device malfunction with the da Vinci S®surgical system and its impact on surgical procedures[J].European Urology Supplements,2015,14(2):e873.
[6]Borden LS Jr,Kozlowski PM,Porter CR,et al.Mechanical failure rate of da Vinci robotic system[J].The Canadian Journal of Urology,2007,14(2):3499-3501.
[7]陈广飞,周丹,张茜.达芬奇手术机器人系统在医疗中的应用[J].机器人技术与应用,2011,(4):11-13.
[8]Won Tae Kim,Won Sik Ham,Wooju Jeong,et al.Failure and Malfunction of da Vinci Surgical Systems During Various Robotic Surgeries:Experience From Six Departments at a Single Institute[J].Urology,2009,74(6):1234-1237.
[9]Nicolas C.Buchs,Fran?ois Pugin,Francesco Volonté,et al.Reliability of robotic system during general surgical procedures in a university hospital[J].The American Journal of Surgery,2014,207(1):84-88.
[10]李澍,李佳戈,苏宗文.医疗器械电磁兼标准解析[J].中国医疗设备,2014,29(2):14-17.