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2015-12-28 品格翻譯繼續(xù)為某跨國(guó)公司提供翻譯服務(wù)。翻譯語(yǔ)種:英譯中。翻譯內(nèi)容:醫(yī)療器械。
譯文摘錄(保密內(nèi)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

待驗(yàn)證要求:(即PR編號(hào)、HCR編號(hào)、標(biāo)準(zhǔn)和條款或RQ和測(cè)試方面)也輸入前面頁(yè)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針對(duì)可見(jiàn)解剖結(jié)構(gòu)返回某一位置的用戶定義容差時(shí)間,包括時(shí)空容差,將允許進(jìn)行自動(dòng)恢復(fù)治療。
72-0170 用戶控制臺(tái)應(yīng)能夠啟動(dòng)治療過(guò)程,包括啟動(dòng)MR成像及同步治療輸出。
72-0320 在治療過(guò)程中,系統(tǒng)應(yīng)能夠在圖像重建后小于1s的時(shí)間內(nèi)顯示一個(gè)平面圖像。
72-0340 在治療過(guò)程中,操作員控制臺(tái)應(yīng)監(jiān)測(cè)預(yù)定義的解剖結(jié)構(gòu),以確定觀察結(jié)果是否超出預(yù)先確定的時(shí)空容差。
72-0350 如果觀察到預(yù)先確定的解剖結(jié)構(gòu)超出時(shí)空容差,那么系統(tǒng)應(yīng)根據(jù)情況中斷治療光束。
72-0360如果觀察到預(yù)先確定的解剖結(jié)構(gòu)超出時(shí)空容差,系統(tǒng)應(yīng)通知操作人員。
72-0370 一旦準(zhǔn)備好患者,操作員控制臺(tái)應(yīng)能夠控制治療單元、輸出治療結(jié)果并采集圖像,同時(shí)使用遠(yuǎn)程A/V監(jiān)控裝置維持與患者的音頻/視頻聯(lián)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 .)

試驗(yàn)方法、設(shè)置:(根據(jù)GP02-05中的規(guī)定說(shuō)明待采用的試驗(yàn)方法。對(duì)于來(lái)自相關(guān)標(biāo)準(zhǔn)的試驗(yàn)程序,需提及標(biāo)準(zhǔn)編號(hào)、版本日期和條款。)

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. 制定治療計(jì)劃以照射體模的可移動(dòng)部分
• 所有頭部采用MB,3號(hào)頭部角度為0。
• 在“可移動(dòng)”目標(biāo)周圍留出10mm的門(mén)控空間距離。將時(shí)間容差設(shè)定為0。使等角點(diǎn)位于該區(qū)域的中間位置。(注意:體模中心距離固定框9cm。)
• 本質(zhì)上目標(biāo)應(yīng)為球形。
•應(yīng)在VR-0157后面附上所用計(jì)劃副本。
2. 設(shè)置所需的所有硬件
• 將門(mén)控體模縱向放置在診查床上。

上一篇:2015-12-9 品格翻譯繼續(xù)為國(guó)內(nèi)規(guī)模最大的門(mén)窗企業(yè)提供翻譯服務(wù)。翻譯語(yǔ)種:中譯英。翻譯內(nèi)容:門(mén)窗城介紹。
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