DOD A-A-54215-1990 SUPPORT CERVICAL《子宫颈支撑》.pdf

1、COMMERCIAL ITEM DESCRIPTION SUPPORT, CERVICAL The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers one type and four sizes of a two-piece, plastic and foam, radiolucent, cervical extrication collar, suitable for immob

2、ilization and maintenance of the cervical spine in a neutral position in order to prevent spinal cord injury during patient extrication. Salient characteristics: The support provided shall be in accordance with the size specified below: Size Description 1 Pediatric size, two-piece, cervical extricat

3、ion support, fits neck circumference 8-16 inches, height 2-1/2 inches. 2 Small size, two-piece, cervical extrication support, fits neck circumference 10-20 inches, height 4 inches. 3 Medium size, two-piece, cervical extrication support, fits neck circumference 12-22 inches, height 4-3/4 inches. 4 La

4、rge size, two-piece, cervical extrication support, fits neck circumference 14-24 inches, height 5-1/2 inches . General. The cervical support collar shall be two-pieces made of lightweight, flexible, 1/8 inch thick low density polyethylene, padded on the interior with 1/4 inch thick charcoal-colored,

5、 closed-cell foam padding to facilitate cleaning and promote reuse. The foam padding shall extend AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. A-A-54215 65 777777Li 0056514 8 I A-A-5 4 2 15 31 July 1990 Provided by IHSNot for ResaleNo reproducti

6、on or networking permitted without license from IHS-,-,-A- A-54215 e past the borders of the polyethylene on all parts of the collar. The foam shall be held to the rigid polyethylene by means of 5/8 inch diameter nylon rivets. The two-pieces of the cervical collar shall be adjustably coupled togethe

7、r by means of woven nylon hook and pile closures, located on both sides of the neck. The anterior portion of the collar shall consist of two polyethylene panels. This anterior piece shall have a diamond shaped tracheal hole, a minimum of 2-1/2 inches in length and 171/2 inches in height which may be

8、 used for access to monitor carotid pulse or for airway management. Each anterior piece shall have a semi-circular, polyethylene chin piece designed to fold down flat for easy, compact storage. A strap of woven nylon pile shall extend from the side of the anterior panel and shall be used to hold the

9、 front piece in position while the posterior piece is applied. A strip of woven nylon hook shall extend across the length of the front panel. The posterior portion of the collar shall be composed of two preformed polyethylene pieces riveted together in a minimum of three places. The smaller piece of

10、 the posterior panel shall be fully padded. The larger piece shall be lined along the bottom and sides with padding. Two pieces (straps) of woven nylon pile shall be riveted to the posterior panel on either side and shall be designed to attach the anterior piece to the posterior piece. When coupled

11、together, the support shall immobilize the cervical area by enclosing the neck, mandible, occiput, and the chin. The low density polyethylene construction shall permit the collar to conform to the patient. The collar shall provide rigid flexion, extension, axial and rotational immobilization. The ce

12、rvical support shall maintain the spine in a neutral orientation during extrication and transport to prevent cervical spinal cord injury. The collar shall have clinical studies documenting capacity to immobilize. The cervical support shall be packaged flat for ease of storage and may be reused. Each

13、 cervical support shall be furnished with an instruction sheet illustrating the sizing and application of the collar and describing the cleaning instructions. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Workmanship. The cervical supports shall

14、be free from defects which detract from their appearance or impair their serviceability. specified, constitutes one unit. Each individual package shall come with “Directions for Use“. Unit. Each (EA). One individual package cervical support, as Quality Assurance Provisions. the contract or purchase

15、order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein,

16、 unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. Responsibility for inspection. Unless otherwise sp

17、ecified in Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available 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

18、after delivery of the supplies to which sch records relate. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investiqation without the - use of special laboratory appliances o; proceduies) and testing (determination by technical means of physical and

19、 chemical properties) of the item. Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and an inspection level of II. The unit of product for examination purposes shall be one cervical support as specified in th

20、is description. Sampling for tests. Sampling for tests including dimensional test shall be conducted in accordance with MIL-STD-105, with an AQL of 1.5 (percent defective) and an inspection level of S-2. The unit of product for test purposes shall be one cervical support . 3 Provided by IHSNot for R

21、esaleNo reproduction or networking permitted without license from IHS-,-,-II .- . - - A-A-54235 b5 W 7777774 0056537 3 W A-A-5 4 2 15 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

22、 more test characteristics. Fastener withstand test. The pile straps of the hook and pile fasteners used for application of the cervical support shall withstand a minimum pull of twenty-five (25) pounds, before detachment from the support. Metric products, be considered on an equal basis with those

23、manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements of this document are met. Products manufactured to metric dimensions will If a product is manufactured

24、 to metric dimensions and those dimensions exceed the tolerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the product is acceptable. The contracting officer has the option of accepting or rejecting the product. Contractor certification. T

25、he contractor shall certify that the product offered meets the salient characteristics of this desckiption and conforms to the producers own drawings, specifications, standards, and quality assurance practices. Government reserves the right to require proof of such conformance prior to first deliver

26、y and thereafter as may be otherwise provided for under the provisions of the contract. The Regulatory requirements. Federal Food, Drug and Cosmetic Act. If the product covered bv this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/con

27、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 thereunder. offeror/contractor shall. comply, and be responsible for compliance by its subcontractors/sup

28、pliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. In addition, the 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54215 65 7777774 0056538 5 U A-A- 5 4 2 15 Recovered materia

29、ls. The offeror/contractpr is encouraged to 0 use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, packinq, labelinq, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a

30、 degree of protection to preclude damage to containers and/or contents thereof 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 regulation

31、s. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. Ordering data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order . NOTE: document : The following National Stock N

32、umbers are covered by this NSN Item Identification 6515-01-263-7723 Support, Cervical, Extrication, Pediatric 6515-01-263-7724 Support, Cervical, Extrication, Small 6515-01-264-1376 Support, Cervical, Extrication, Medium 6515-01-263-7725 Support, Cervical, Extrication, Large MILITARY INTERESTS: PREP

33、ARING ACTIVITY: Custodians : DoD - MB Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS USPHS FDA-MPQAS 5 Project No. 6515-4763 Location: CID/SUPPORT/CERVICAL/Hl5-37 O Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-