英语翻译1.Scope(概述)1.1Applicable procedures(正确使用步骤).1.1.1.The device will be used for Single Port Access and other advanced laparoscopic procedures.Tasks may include grasping,clamping,and manipulating of targeted tissue..1.2.Produ

英语翻译1.Scope(概述)1.1Applicable procedures(正确使用步骤).1.1.1.The device will be used for Single Port Access and other advanced laparoscopic procedures.Tasks may include grasping,clamping,and manipulating of targeted tissue..1.2.Produ
英语翻译
1.Scope(概述)1.1Applicable procedures(正确使用步骤).1.1.1.The device will be used for Single Port Access and other advanced laparoscopic procedures.Tasks may include grasping,clamping,and manipulating of targeted tissue..1.2.Product description.1.2.1.5 mm disposable fenestrated alligator grasper.Includes an articulating distal tip with angle lock,an ergonomic handle,and ratcheting jaws.1.2.2.CED Catalogue Number LA5401-01,AML Part Number 1303-10428.1.1.3.Features.1.3.1.Plastic ergonomic handle-grip.1.3.2.Jaw activation controlled by a variable force ratchet.
1.3.3.Articulation of jaws created by motion of handle.1.3.4.Angle locking mechanism preserves the angle of articulation.1.3.5.Fenestrated jaws with coarse teeth.2.0.Functional requirements.2.1.Safety.2.1.1.Patient/device risk is assessed throughout the project with consideration to ISO 14971 and 21 CFR 878.4400.2.1.2.Devices are designed and manufactured in compliance with ISO 13485 and 21 CFR part 820.2.2.Performance expectations.2.2.1.Dimensional
2.2.1.1.Instrument Shaft Diameter of 5.13 mm ± 0.35 mm (to interface with 5 mm cannula).2.2.1.2.Usable length:34.0 cm ± 1.0 cm.2.2.1.3.Jaws are straight with staggered coarse teeth.There are five sets of teeth in the jaws.Minimum usable length of jaws is 0.8”.2.2.1.4.Minimum jaw opening distance is 0.9”.
2.2.1.5.Yoke and distal flex section to be 5 mm nominal diameter with a maximum diameter of 5.5 mm at the distal cover adhesive line.
2.2.1.6 Distal section of main tube to be covered with 2.5 + 0.50/- 0.25” of black heat shrink,overlapping the distal cover at least 0.25”.
2.2.2.Mechanical
2.2.2.1.The instrument shall be capable of making the equivalent of 100 grasps:clamping 50 times fully closed and locked without anything in the jaws,and 50 times with a 0.165” rod/rubber tube in the jaws just behind the most proximal teeth.
2.2.2.2.The device includes a return spring to open the jaws when the ratchet is released.
2.2.2.3.Travel in trigger to open and close jaws is greater than 0.25” and less than 0.75”.
2.2.2.4.The jaws should be closed after 7 ratchet clicks,leaving 3 additional ratchet clicks before the actuation lever is fully depressed.

英语翻译1.Scope(概述)1.1Applicable procedures(正确使用步骤).1.1.1.The device will be used for Single Port Access and other advanced laparoscopic procedures.Tasks may include grasping,clamping,and manipulating of targeted tissue..1.2.Produ
2.2.1.1.Instrument轴直径5.13毫米± 0.35毫米（至5毫米接口套管）.2.2.1.2.可用长度：34.0厘米± 1.0 cm.2.2.1.3.Jaws用粗齿直交错.有5人的牙齿在颌骨.最低可用颌骨的长度是0.8“.2.2.1.4.距离最小开度为0.9”.
和棘轮jaws.1.2.2.CED目录编号LA5401 - 01,反洗钱零件编号1303 - 10428.1.1.3.Features.1.3.1.Plastic符合人体工程学的手柄grip.1.3.2.Jaw活化一变力棘轮控制.
范围（概述）1.1Applicable程序（正确使用步骤）.1.1.1.该设备将用于单端口接入和其他先进的腹腔镜手术.任务可能包括抓,钳,并有针对性的组织操纵..1.2.产品description.1.2.1.5毫米一次性窗孔鳄鱼grasper.包含一个带有角度锁定,阐明了符合人体工程学的处理远端一角,
设备的设计和符合ISO 13485和21 CFR Part 820.2.2.Performance遵守生产expectations.2.2.1.Dimensional
2.2.1.1.Instrument轴直径5.13毫米± 0.35毫米（至5毫米接口套管）.2.2.1.2.可用长度：34.0厘米± 1.0 cm.2.2.1.3.Jaws用粗齿直交错.有5人的牙齿在颌骨.最低可用颌骨的长度是0.8“.2.2.1.4.距离最小开度为0.9”.
由锁定机制handle.1.3.4.Angle议案在下巴1.3.3.Articulation保持与粗teeth.2.0.Functional requirements.2.1.Safety.2.1.1.Patient articulation.1.3.5.Fenestrated颌骨角/设备的风险评估与考虑整个的ISO 14971和21 CFR 878.4400.2.1.2项目.
范围（概述）1.1Applicable程序（正确使用步骤）.1.1.1.该设备将用于单端口接入和其他先进的腹腔镜手术.任务可能包括抓,钳,并有针对性的组织操纵..1.2.产品description.1.2.1.5毫米一次性窗孔鳄鱼grasper.包含一个带有角度锁定,阐明了符合人体工程学的处理远端一角,
2.2.2.Mechanical
2.2.1.5.Yoke和远端弯曲部分,为5毫米标称直径为5.5毫米,远端覆盖胶行的最大直径.
2.2.1.6远端主要管部分覆盖着2.5 + 0.50 / - 0.25黑热“收缩,重叠,远端覆盖至少0.25”.
2.2.2.2.The设备包括一个返回春天开放时,棘轮下颚被释放.
2.2.2.1.The文件应能够使相当于100把握：夹紧50次完全封闭,没有任何的下巴被锁定,50倍和0.165的“棒/在颌骨胶管仅次于最近端牙齿.

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哇擦，这么多，到什么时候才能翻译完啊！

一份都不赏 谁愿意给你翻译 闲着了