2015-12-28 品格翻译继续为某跨国公司提供翻译服务。翻译语种:英译中。翻译内容:医疗器械。

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2015-12-28 品格翻译继续为某跨国公司提供翻译服务。翻译语种:英译中。翻译内容:医疗器械。

 

译文摘录(保密内容以XXX代替):

Requirement (s) to be verified: (i.e.,PR#,HCR#,standard and clause or RQ and aspect being tested) Also enter on front header

待验证要求:(即PR编号、HCR编号、标准和条款或RQ和测试方面)也输入前面页眉上

PRD 71-0365 A user defined tolerance time for visible anatomical structures to return to a position with spatial and temporal tolerances will allow treatment to automatically resume.
72-0170 The user console shall be able to initiate a treatment which includes initiation of MR imaging with simultaneous treatment delivery .
72-0320 The system shall be capable of displaying one planar image during therapy in <1second after image reconstruction.
72-0340 The operator’s console shall,during treatment ,monitor a predefined anatomical structure to determine if it is observed to be outside of the predetermined spatial and temporal tolerances.
72-0350 If the predetermined anatomical structures are observed to be outside of the spatial and temporal tolerances ,then the system shall optionally interrupt the treatment beams.
72-0360 If the predetermined anatomical structure is observed to be outside of the spatial and temporal tolerances,then the system shall notify the operator.
72-0370 The operator’s console shall be capable of controlling the unit,delivering treatments ,and acquiring images once the patient is set up while maintaining audio/visual contact with the patient using remote A/V surveillance devices.

PRD 71-0365针对可见解剖结构返回某一位置的用户定义容差时间,包括时空容差,将允许进行自动恢复治疗。
72-0170 用户控制台应能够启动治疗过程,包括启动MR成像及同步治疗输出。
72-0320 在治疗过程中,系统应能够在图像重建后小于1s的时间内显示一个平面图像。
72-0340 在治疗过程中,操作员控制台应监测预定义的解剖结构,以确定观察结果是否超出预先确定的时空容差。
72-0350 如果观察到预先确定的解剖结构超出时空容差,那么系统应根据情况中断治疗光束。
72-0360如果观察到预先确定的解剖结构超出时空容差,系统应通知操作人员。
72-0370 一旦准备好患者,操作员控制台应能够控制治疗单元、输出治疗结果并采集图像,同时使用远程A/V监控装置维持与患者的音频/视频联系。

 

Test Method,Set-up: (Describe test method to be used as defined in GP02-05.Test procedures from standards must reference standard number,edition date,and clause .)

试验方法、设置:(根据GP02-05中的规定说明待采用的试验方法。对于来自相关标准的试验程序,需提及标准编号、版本日期和条款。)

1. Create a treatment plans to irradiate the movable part of the phantom
• All heads MB; Head 3 shall be at 0 degrees.
•There should be a 10mm spatial gating margin placed around the “moveable” target. Temporal tolerance set at O. Place the is center in the middle of this region. (Note the center of the phantom is 9 cm from the fixed box).
•Targets should be spherical in nature
•A copy of the plan used should be attached to VR-0157.
2. Set Up all required hardware.
•Place the gating phantom on longitudinally on the couch.

1. 制定治疗计划以照射体模的可移动部分
• 所有头部采用MB,3号头部角度为0。
• 在“可移动”目标周围留出10mm的门控空间距离。将时间容差设定为0。使等角点位于该区域的中间位置。(注意:体模中心距离固定框9cm。)
• 本质上目标应为球形。
•应在VR-0157后面附上所用计划副本。
2. 设置所需的所有硬件
• 将门控体模纵向放置在诊查床上。

 

 

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发布日期: 2015-12-28