Health Devices. 1992 Sep;21(9):311-5.
This update to our recent Evaluation "Surgical Lasers" (Health Devices 20[7-8], July-August 1991) provides information about the Xintec Optica 120 Nd:YAG surgical laser, which was not available at the time of our original study and which has several unique features. Xintec also offers a 50 W, 120 VAC version of this laser, the Optica 60, which we did not evaluate; the manufacturer states that these models share many of the same features. The criteria and test methods used to evaluate the Optica 120 can be found on pages 252 to 260 in the 1991 issue. Below, we briefly describe the unit in the Characteristics section, and we provide an overall rating for the unit, as well as an individual rating for each major test, in the Significant Test Results and Ratings section. Under each of these tests, we report on features that are unique to this laser or that surpassed our criteria and would likely be considered by hospitals during the selection process. We also report on limitations and deficiencies that failed to meet our criteria, that are hazardous, or that played a significant role in our rating for both the test category and the unit, as well as any modifications that the manufacturer has made to the unit to address our concerns. Some reliability problems that we encountered during testing are also discussed to provide users with some indication of the laser's performance and service requirements; however, this information was not used in determining the unit's rating. Also see the "Laser Technology Planning" and "Laser Use and Safety" Guidance Articles in this issue.
本次对我们近期的《外科激光评估》（《医疗设备》20[7 - 8]，1991年7 - 8月）进行更新，提供了有关新特克光学120 Nd:YAG外科激光的信息，该激光在我们最初研究时还未上市，且具有若干独特特性。新特克还提供这款激光的50瓦、120伏交流版本，即光学60型，我们未对其进行评估；制造商表示这些型号具有许多相同特性。用于评估光学120型的标准和测试方法可在1991年那期的第252至260页找到。下面，我们在“特性”部分简要描述该设备，并在“重要测试结果及评级”部分给出该设备的总体评级以及每项主要测试的单独评级。在每项测试下，我们会报告该激光独有的特性、超过我们标准且医院在选择过程中可能会考虑的特性。我们还会报告未达我们标准、存在危险或在我们对测试类别及该设备的评级中起重要作用的局限性和缺陷，以及制造商为解决我们的担忧而对该设备所做的任何改进。我们还会讨论测试过程中遇到的一些可靠性问题，以便为用户提供该激光性能及服务要求的一些指示；然而，此信息未用于确定该设备的评级。另请参阅本期的“激光技术规划”和“激光使用与安全”指导文章。
