DOD A-A-53481-1988 STAPLER SURGICAL (INTRALUMINAL)《外科原材料(鲁米诺一种镇静剂)》.pdf
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1、A-A-53q81 65 9999974 0030861 9 m P- 3/- 91 A-A-5 3 4 8 1 a May 1988 COMMERCIAL ITEM DESCRIPTION STAPLER, SURGICAL (INTRALUMINAL) The General Services Administration has approved the use of this commercial item description. This commercial item description covers an intraluminal surgical stapler suit
2、able for use in colo-rectal, intestinal, and esophageal surgery, Salient characteristics: Style and design. Style and design of the stapler shall be in accordance with Fiqures 1,2 and 3. The stapler shall consist of a center-rod assembly and instrument-body assembly. The center-rod assembly shall co
3、ntain all of the moving parts of the stapler, except for the bayonet-sleeve mechanism. The instrument body assembly shall contain of all stationary stapler parts, bayonet-sleeve mechanism, and moveable handle. The design of the moveable handle and its pivot screw shall permit the user to remove and
4、attach the handle without loss of pivot screw. Stapler design shall permit disassembly, cleaning and re-assembly. Materials. The stapler shall be fabricated from suitable corrosion-resistant steels that conform to ASTM Designation F899. Performance. The stapler shall perform the following functions:
5、 1) The safety latch shall prevent stapler operation until manually unlocked. 2) The drive shaft shall advance when the user turns the wing nut counterclockwise. The drive shaft shall retract when the user turns the wing nut clockwise. 3) The drive tube shall advance when the user gives a firm squee
6、ze on the instrument handles. The drive tube shall retract when the user releases the handle. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. , THIS DOCUMENT CONTAINS 7 PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted wit
7、hout license from IHS-,-,-A-A-53qI b5 7771i 00308bi! O I A-A-53 4 8 1 4) The bayonet-sleeve mechanism shall accept a compatible staple-unit cartridge and lock it in place when the user gives the bayonet-sleeve a I/& turn clockwise. It shall stay in position until manually unlocked by the user. 5) Wh
8、en loaded with a compatible staple unit, the stapler shall effect a circular anastomosis on the tissues to be joined and resect all excess tissues from the joint provided the wer has followed the instruction manual. Workmanship. The surgical stapler shall be free rom any defects which detract from i
9、ts appearance or impair its serviceability. Unit. Each (EA). One surgical stapler, as specified, constitutes one unit. Quality Assurance Provisions. Responsibility for inspection. Unless otherwise specified in the contract: or purchase order, the contractor is responsible for the performance f all i
10、nspection requirements as speif ied herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performanee of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves th
11、e right to perform any o the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conLorm to prescribed requirements, R-. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and m
12、ade avalahle to the Government upon the Governments request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate . Inspection. Inspection, as used herein, is defined as both examination
13、(such as visual or auditory investigation without the use CI special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Sampling or inspection. Sampling for inspection shall be conucte in accordance with MIL-STD-105 at
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