1、t a A-A-5 3 5 O O 11 May 1988 COMMERCIAL ITEM DESCRIPTION STAPLER, SURGICAL, THORACIC-ABDOMINAL The General Services Administration has authorized the use of this commercial item description. This commercial item description covers one type of reusable surgical stapler . Salient characteristics: Sty
2、le and design. Style and design of surgical staplers shall be in accordance with Figure 1. Staplers shall consist of seven major components. (1) Frame. The frame shall hold and align the stapler components via a suitable internal mounting system. The frame shall be slotted to permit cleaning. The fr
3、amesproximal end shall contain an integral, fixed handle. Its distal end shall contain jaws suitable for housing a compatible staple unit. (2) Moveable handle. The moveable handle shall be spring-biasd and mounted inside the stapler frame. The moveable handle shall engage the approximating lever ass
4、embly by means of a “Tongue and Groove arrangement. (3) Safety latch. The safety latch shall be mounted inside the stapler frame. :-(4) Release lever. The release lever shall be mounted inside the stapler frame. (5) Actuator assembly. The actuator assembly shall consist of a spring-biased actuator r
5、od and a housing with an integral lift-plate and a set of distal guide lugs: The proximal end of the actuator assembly shall be mounted on the mechanical linkage (See #7). The distal end of the assembly shall be supported by the guide lugs which ride in extended slots in the stapler frame. AMSC N/A
6、FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS A PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-SqSq774 003OS41r 7 M A-A-535 O0 The approximating lever A-A=535OO b5 (6) A piox
7、imatinq lever assembly. assedy shall contain a housing and a sp2ing-biased- approximating rod. The distal end of the assembly shall be mounted on the mechanical linkage. The mid-point o the assembly shall be mounted inside the stapler frame. (7) Mechanical linkage. The mechanical linkage shall be sp
8、ring-biased and suitable for transmitting orce between the aiproiimating lever and actuator assemblies. Materials. Surgical staplers shall be fabricated from corrosion- resisting steels, properly tempered and passivated. All materials shall be suitable or the purpose intended. Perormance. units as i
9、ndicated in Table I. Staplers shall be compatible with the surgical staple TABLE I. Stapler - Staple Unit Compatibility t NSN: Stapler NSN: Stapling Unit I 8 6 6515-01-204-5362 6515-01-207-8222 6515-01-204-5362 6515-01-207-8223 6515-01-204-5364 6515-01-207-8224 6515-01-204-5364 6515-01-207-8225 6515
10、-01-204-5365 6515-01-207-8219 6515-01-204-5365 6515-61-207-8220 6515-01-204-5365 6515-01-207-8221 Staplers shall place a linear, double-staggered row of surgical staples when loaded with a compatible staple unit. peiform the Eollowing functions: (1) manually unlocked. (2) eacilitate cleaning. Staple
11、rs shall The safety latch shall prevent stapler operation until The actuator assembly shall pivot out: of the stapler to (3) As the approximating lever is being closed, the actuator assembly shall advance and close the compatible staple unit. appmximating rod shall engage the moveable handle. The 2
12、Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53500 65 m 7777774 0030742 7 m A-A-5 3 5 O O (4) When the moveable handle is squeezed, the approximating and actuator rods shall simultaneously advance. The distal tip of the actuator rod shall actu
13、ate the compatible staple unit. When the handle is released, both rods shall simultaneously retract. (5) The release lever shall unlock the stapler. When this lever is applied, the approximating assembly shall pivot up to a vertical position and the actuator assembly shall retract and allow the stap
14、le unit to open. Instructions. Each stapler shall be supplied with a “Directions for Use“ manual. Workmanship. Surgical staplers shall be free from defects that detract from their appearance or impair their serviceability. Unit. Each (EA). One surgical stapler, together with directions for use, as s
15、pecified, 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 of all inspection requirements as specified herein. Except as otherwise specified in the contra
16、ct or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such ins
17、pections are deemed necessary to assure supplies and services conform to prescribed requirements. Records. Records of examinations and tests performed by or for th contractor shall be maintained by the contractor and made available tc the Government upon the Governments request, at any time, or from
18、 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. examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by techn
19、ical means of physical and chemical properties) of the item. Inspection. Inspection, as used herein, is defined as both Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more-test cha
20、racteristics. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53500 b5 974 00309Y3 a A-A-5 3 5 O O SampSinq for inspection. Sampling for inspection shall be conducted in accordance with MIL-STD-105 at Level S-2, AQL 1.0%. The unit sf product fo
21、r inspection purposes shall be one surgical stapler. As an alternate, staplers may be 100% inspected for compliance with this spcification and the manufacturers own blueprints and performance specifications. Contractor certification. The contractor shall certify that the pro&uct offered meets the sa
22、lient characteristics of this description and conforms to the producers own drawings, specifications, standards, and quality assurance practices, The Government reserves the right to require proo of such conformance prior to first delivery and thereaeter as may be otherwise provided for under the pr
23、ovisions of the contract, Regulatory requirements. Federal Food, Drug and Cosmetic Act. IL the pzoduct covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its sub
24、conlractors/supplier, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible or: compliance by its subcontractors/suppliers, with the requirements of all other applicab
25、le Federal, State, and local statutes, ordinances, and regulations. recovered material in accordance with Public Law 94-580 to the maximum extent practical, Recovered materials. The offeror/contractor is encouraged to use Preservation, packaging, packing, labeling, and marking. Unless -specified, pr
26、eservation, packaging, and packing shall be to a degree of-protection to preclude damage to containers and/or contents thereof undeg normal shipping conditions, handling, etc. involving shipment from the supply source to the receiving activity, pius reshipment from receiving activity, and shall conf
27、orm to applicable carriers rules and regulations. package quantities and labeling and marking shall be as specified in the contract and/or order. Intermediate and exterior KOTE: documents The following National Stock Numbers are covered by this 4 Provided by IHSNot for ResaleNo reproduction or netwo
28、rking permitted without license from IHS-,-,-A-A-53500 65 777777Li 00307LiI 2 M c A-A-535 O O 3 NSN 6515-01-204-5362 - 6515-01-204-5364 6515-01-204-5365 ITEM IDENTIFICATION STAPLER, SURGICAL, Thoracic- Abdominal, 90 mm. STAPLER, SURGICAL, Thoracic- Abdominal, 55 mm. STAPLER, SURGICAL, Thoracic- Abdo
29、minal, 30 mm. Ordering data. (Intermediate/exterior package quantities and labelinc and marking must be specified in the contract and/or order). MILITARY INTERESTS: Preparing Activity: Custodians: DoD-MB Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL COORDINATING ACTIVITIES: VA-OSS PHS FDA-M
30、PQAS Project No. 6515-3973 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-I A-A-53500 65 4994974 003044C Y A-A-53500 FIGURE I STAPLER, SURGICAL SUTURE 9 AUTOMATIC (FOR GENERAL CTKE ANO OSiGN) *U.% GOVERNMENT MINTiNG OFFICE: tl* S49493/9Z#S 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
