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荷兰六家医院对ScopeControl内窥镜测试系统的评估。

Evaluation of the ScopeControl endoscope test system in six hospitals in The Netherlands.

作者信息

Noordmans Herke Jan, de Braak Menno, Wientjes Rens, Martens Esther, Lindenhovius Karianne, Swart Paul

机构信息

Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, The Netherlands.

Research & Development, DOVIDEQ Medical, Deventer, The Netherlands.

出版信息

Phys Med. 2015 Mar;31(2):152-8. doi: 10.1016/j.ejmp.2014.12.006. Epub 2015 Jan 15.

DOI:10.1016/j.ejmp.2014.12.006
PMID:25599625
Abstract

As rigid endoscopes are re-used after minimal invasive surgery, they degrade over time. To guarantee the optical quality of a rigid endoscope, the ScopeControl has been developed to measure key optical parameters such as, light transmission (LT), color correctness (CC), focus (FC), fiber transmission (FT), viewing angle (VA) and field of view (FV). To evaluate the performance of the ScopeControl, five ScopeControls SV (study version) have been tested in six hospitals in the Netherlands. Aspects such as robustness, precision, usability of the measured data, acceptation criteria and ergonomic aspects have been assessed. The ScopeControl maintains its stability over time and can measure LT, CC and FC with 5% precision, VA and FV with 2% accuracy and FT with 10% precision. The final thresholds above which an endoscope could still be considered to be in good condition, appeared to be: VA at 75%, CC, FC and FV at 70%, LT at 65% and FT at 35% of that of the best endoscope of that type ever found. The ScopeControl SV fits the workflow of the sterilization department as it is easy to use and can easily be cleaned. The time to perform a measurement is 2-3 min (one minute is spent to select the correct endoscope). The ScopeControl PV (launched in November 2013), has been used clinically from April to November 2014. It proves to be more stable, well accepted by personnel from the sterilization department and be of large value of preventing defect endoscopes on the surgery table.

摘要

由于硬性内窥镜在微创手术后会被重复使用,随着时间推移会逐渐老化。为确保硬性内窥镜的光学质量,研发了ScopeControl来测量关键光学参数,如光传输(LT)、颜色正确性(CC)、焦距(FC)、光纤传输(FT)、视角(VA)和视野(FV)。为评估ScopeControl的性能,在荷兰的六家医院对五个ScopeControl SV(研究版本)进行了测试。对其稳健性、精度、测量数据的可用性、验收标准和人体工程学方面等进行了评估。ScopeControl随时间保持稳定,可精确测量LT、CC和FC,精度为5%;测量VA和FV,准确度为2%;测量FT,精度为10%。最终确定的内窥镜仍可被视为状况良好的阈值如下:VA为75%,CC、FC和FV为70%,LT为65%,FT为所发现的该类型最佳内窥镜的35%。ScopeControl SV符合消毒科室的工作流程,因为它易于使用且易于清洁。进行一次测量的时间为2至3分钟(其中一分钟用于选择正确的内窥镜)。ScopeControl PV(于2013年11月推出)在2014年4月至11月期间已投入临床使用。事实证明它更稳定,深受消毒科室人员的认可,对于防止手术台上出现有缺陷的内窥镜具有很大价值。

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