Wang Quanzeng, Khanicheh Azadeh, Leiner Dennis, Shafer David, Zobel Jurgen
U.S. Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
PENTAX Medical, 1 Broadway, 14th Floor, Cambridge MA 02142, USA.
Biomed Opt Express. 2017 Feb 7;8(3):1441-1454. doi: 10.1364/BOE.8.001441. eCollection 2017 Mar 1.
The current International Organization for Standardization (ISO) standard (ISO 8600-3: 1997 including Amendment 1: 2003) for determining endoscope field of view (FOV) does not accurately characterize some novel endoscopic technologies such as endoscopes with a close focus distance and capsule endoscopes. We evaluated the endoscope FOV measurement method (the FOV method) in the current ISO 8600-3 standard and proposed a new method (the FOV method). We compared the two methods by measuring the FOV of 18 models of endoscopes (one device for each model) from seven key international manufacturers. We also estimated the device to device variation of two models of colonoscopes by measuring several hundreds of devices. Our results showed that the FOV method was more accurate than the FOV method, and could be used for all endoscopes. We also found that the labelled FOV values of many commercial endoscopes are significantly overstated. Our study can help endoscope users understand endoscope FOV and identify a proper method for FOV measurement. This paper can be used as a reference to revise the current endoscope FOV measurement standard.
当前国际标准化组织(ISO)用于确定内窥镜视野(FOV)的标准(ISO 8600 - 3:1997,包括修订版1:2003)无法准确描述一些新型内窥镜技术,如具有近距离聚焦功能的内窥镜和胶囊内窥镜。我们评估了现行ISO 8600 - 3标准中的内窥镜FOV测量方法(FOV方法),并提出了一种新方法(FOV方法)。我们通过测量来自七个主要国际制造商的18种型号内窥镜(每个型号一台设备)的FOV来比较这两种方法。我们还通过测量数百台设备评估了两种型号结肠镜的设备间差异。我们的结果表明,FOV方法比FOV方法更准确,并且可用于所有内窥镜。我们还发现,许多商用内窥镜标记的FOV值被显著高估。我们的研究有助于内窥镜用户了解内窥镜FOV,并确定一种合适的FOV测量方法。本文可作为修订当前内窥镜FOV测量标准的参考。