问题描述：
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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.
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.
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