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
14、 level S-2, AQL 1.0%. The unit sf product shall be one stapler. specification requirements. Where feasible, the same sample shall be used foi the determination of two or more test characteristics. Tests. Tests shall be conducted to determine compliance with 2 Provided by IHSNot for ResaleNo reproduc
15、tion or networking permitted without license from IHS-,-,-A-A-5 24 81 , Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers own drawings, specifications, standards, and quality assurance p
16、ractices. The Government reserves the right to require proof of such conformance prior to first-delivery and thereafter as may be otherwise provided for under the provisions of the contract. Regulatory requirements. Federal Food, Drug and Cosmetic Act. If the product covered by this document has bee
17、n determined by the U.S. Food and Drua Administration to be under its juriidiction, the offeror/c&tractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereun
18、der. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. . Recovered materials. The offeror/contractor is encouraged to use
19、recovered material in accordance with Public Law 94-580 to the maximum extent practical. Preservation, packaging, packing, labeling, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents there
20、of under normal shipping conditions, handling, etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterior package quantities and labeling and marking sha
21、l be as specified in the contract and/or order. NOTE: document: The following National Stock Numbers is covered by this NSN Item Identification - 6515-01-205-2379 STAPLER, SURGICIAL, INTRALUMINAL NOTE: document: The following are compatible with the stapler covered by this NSN - 6515-01-151-1835 Ite
22、m Identification STAPLE UNIT, SURGICAL, Intraluminal 31.6 mm, Disposable, 12s 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53481 ns FIGURE 1 _ STAPLER, SURGICAL, INTRALUMINAL 1) Movable Handle 2) Fixed Handle 3) Safety Latch 4)-Pivot Screw 5
23、) Mounting Collar 6) Wing Nut 7) Drive Tube 8) Drive Shaft 9) Bayonet-Sleeve Mechanism (See Figure 3) 10) Viewing Window (See Figure 2) 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53481 ns FIGURE 1 _ STAPLER, SURGICAL, INTRALUMINAL 1) Movab
24、le Handle 2) Fixed Handle 3) Safety Latch 4)-Pivot Screw 5) Mounting Collar 6) Wing Nut 7) Drive Tube 8) Drive Shaft 9) Bayonet-Sleeve Mechanism (See Figure 3) 10) Viewing Window (See Figure 2) 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-SJ
25、qBL 65 4339434 3bb 8 e FIGURE 2 VIEWING WINDOW, ESRGICAL STAPLER a 1) View Port 2) Wide Alignment Marke 3) Drive Tube 4) Alignment Notches 5) Drive Shaft 6) Narrow Alignment Mark 7) Instrument Body Housing 8) Body Tube 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without li
26、cense from IHS-,-,-A-A-534L 65 m 7777774 0030b7 T 8 7 A-A-5 34 8 L FIGURE 3 BAYONET-SLEEVE MECHANISM. 1) Bayonet-Sleeve 2) Body Tube 3) Drive Tube 4) Drive Shaft 5) Retaining Spring 6) Cartridge Key 7) Snap Ring 8) Retaining Pin 9) Vent (Typical) Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
