In this Update of our July 1995 Evaluation (Health Devices 24[7]), we tested three high-flow laparoscopic insufflators not covered in the original study. In this issue, we are again using the Product Profile Evaluation format that we introduced in our August 1996 (25[8]) Update Evaluation of automated external defibrillators; see the inset on page 14 for a detailed explanation of this new format. In brief, we evaluated the three new units using the same criteria and test methods as in the July 1995 study and rated and ranked the units according to the same overall scheme. Because our criteria and test methods have not changed since the original study, we have not repeated them in this issue; readers should refer to the July 1995 issue for that information. Instead, in a series of Product Profiles, we present the characteristics, test results, and ratings for each newly evaluated unit individually. Following the profiles, a comprehensive Conclusions section details how the newly evaluated units compare with those evaluated in our original study. One of the units evaluated in this issue is rated Acceptable. The other two are rated Conditionally Acceptable because of their inability to provide adequate pressure relief; a secondary gas source should not be applied in the pneumoperitoneum while these units are in use. Of the 16 units we have evaluated to date, nine are rated Acceptable and seven are rated Conditionally Acceptable.
在本次对我们1995年7月评估(《医疗设备》第24卷第7期)的更新中,我们测试了三项原始研究未涵盖的高流量腹腔镜气腹机。在本期中,我们再次采用了我们在1996年8月(第25卷第8期)对自动体外除颤器的更新评估中引入的产品简介评估格式;有关这种新格式的详细解释,请参见第14页的插图。简而言之,我们使用与1995年7月研究相同的标准和测试方法对这三个新设备进行了评估,并根据相同的总体方案对这些设备进行了评级和排名。由于自原始研究以来我们的标准和测试方法没有改变,因此我们在本期中没有重复这些内容;读者可参考1995年7月那期获取相关信息。相反,在一系列产品简介中,我们分别介绍了每个新评估设备的特点、测试结果和评级。在这些简介之后,一个综合的结论部分详细说明了新评估的设备与我们原始研究中评估的设备相比情况如何。本期评估的设备中有一台被评为可接受。另外两台被评为有条件接受,因为它们无法提供足够的压力释放;在使用这些设备时,气腹过程中不应使用辅助气源。在我们迄今为止评估的16台设备中,9台被评为可接受,7台被评为有条件接受。