DOD A-A-53459-1988 SUCTION APPARATUS SURGICAL《外科吸力装置》.pdf

1、b A-A-53Ll57 65 7777774 003076b Li l A-A-53 459 15 December 1988 7 COMMERCIAL ITEM DESCRIPTION SUCTION APPARATUS, SURGICAL The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a suction apparatus suitable for use in a

2、n ambulance, hospital, or in a stationary field hospital to aspirate secretions, blood, or vomitus as necessary. Salient characteristics: The apparatus shall be capable of being powered via manual operation (component hand operated pump), hospital wall vacuum, or vehicle vacuum system as an oral, na

3、sal, and tracheal suction device. The apparatus shall be suitable for use in aspirating secretions, blood, and vomitus during emergency treatment including treatment of apnea patients. In addition to requirements specified herein, all components, attachments, materials, and functions shall be in com

4、pliance with ASTM F960 (Standard Specification for Medical and Surgical Suction and Drainage Systems) as applicable for specified use. The apparatus shall consist of, at least, a double cycle hand pump, a collection/vacuum container with a container liner installed, vacuum gauge, a vacuum adjustment

5、 control, a patient suction tube, a vehicle vacuum hose, all necessary interconnecting parts, all assembled on a base plate with a removable hold down bracket, ready for use when equipped with a noncomponent catheter. A package of 24 vacuum container liners, and operating and maintenance manual(s1 s

6、hall also be included . The hand pump shall provide suctioning when operated in either direction (push-pull), and shall have a minimum displacement . of 12.5 cubic inches (0.205 liters) per stroke. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release: distribution is unlimited. TH

7、IS DOCUMENT CONTAINS ;/ PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-b3Li59 b5 W 7Y 00307b7 b m A-A-53 459 c t O The collection/vacuum container, with a liner installed, shall have a minimum capacity of 2300 cc and the contents o the 13

8、nei: shall be clearly viewable during use (i.e, installed liner shall also have minimum capacity of 2300 cc). container liner shall have graduation markings. The vacuum gauge shall have a range from O to a minimum of 30 inches (63.5 cm) Hg. The The vacuum adjustment control shall be hand operated an

9、d easily accessed. It shall be capable of controlling the vacuum rom O to 28 inches (63.5 cm) Hg. The high limit of tree air flow shall be 38.5 LPM. The patient suction tube shall be 1/4 inch (0.635 cm) ID by a minimum o 5 feet (1.52 meters) and shall be sterilizable via ethylene oxide and liquid ag

10、ent (s) . The vehicle vacuum hose shall be a minimum 16 feet (4.88 meters) long by at least 1/4 inch (0.64 cm) ID. The complete apparatus, less packaging, package of liners, and manual(s) shall not weigh more than 7 pounds (3.18 kg), Performance, When manually operated at the rate o two double strok

11、es (2 full cycles) per 2.4 seconds, the apparatus shall provide a minimum of 27.0 inches (68.58 cm) Hg negative pressure with the patient tubing occluded and a minimum of 35 LPM Eree ait. flow at the patient end of the non-occluded tubing. When cycle rate is increased, the free air flow shall be lim

12、ited to a minimum of 38.5 EPM. O When operated from a noncomponent vacuum source (vehicle vacuum or electrical vacuum pump) which has an excess of vacuum and ree air flow, the vacuum adjustment control shall provide a range from 0 to a minimum of 27.5 inches (69.85 cm) Hg. The apparatus shall be cap

13、able of providing a minimum o 30 LPM ree air flow at the patient end of the tube. Materials. A1L pazts shall be corrosion-resistant or treated For corrosion-resistance (paint is not acceptable as a corrosion-resistant treatment), 2 Provided by IHSNot for ResaleNo reproduction or networking permitted

14、 without license from IHS-,-,-A-A-5 3 45 9 Instructions. The apparatus shall be-provided with manual(s1 describing the theory of operation, operating instructions, assembly and disassembly instructions, a list of replacement parts by manufacturers catalog number, descriptive sketches and appropriate

15、, st-atement of warranty, and manufacturers name, address and phone number. Workmanshi . The suction apparatus shall be free from defects Unit, Each (EA). One suction apparatus, as specified, which d etract from its appearance or impair its serviceability. constitutes one unit. Each suction apparatu

16、s shall be provided with operating and maintenance instructions for use. Quality Assurance Provisions. 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 contract or purchase order

17、, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified hereinr unless disapproved by the Government. Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed nece

18、ssary to assure supplies and services conform to prescribed requirements. Responsibility for inspection. Unless otherwise specified in The 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

19、 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. -Ins ection. Inspection, as used herein, is defined as both examination + such as visual or auditory investigat

20、ion without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. 3 , Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-I A-A-5 3 45 9 O Tests. Tests shal

21、l be conducted to determine compliance with spemation requirements. shaU be used for the determination of two or more test ChiXaCtriStGS. All tests listed under Tests and required by ASTM F 960 shall be pereormed. Where Eeasible, the same sample I Unit; not clean. Sampling for examination. Sampling

22、for examination shall be con8ucted in accordance with MIL-STD-105, with an AQL of 4 (percent defective) and an inspection level of S-1. product for examination purposes shall be one suction apparatus ars specified in this description. The unit of Deects. Unit not complete with all component parts. C

23、omponents not free from damage including (but not restricted to) cracks, checkingr breaks, and deformed areas of the collection containers, and tubing. Finish not Eree rom blistering, checkingr peeling, scratching, or bare areas. Any screws not drawn up tight; xivet not properly installed. Service d

24、ata not included. Metal parts not free from corrosion. Hand pump is not double cycle. Sampling for tests, Sampling for tests, including dimensional test shall be conducted in accordance with MIL-STD-105, with an AQL af 2.5 (percent defective) and an inspection level of II. The unit of product or tes

25、t purposes shall be one suction apparatus . all tests shall be performed on that unit. a. First article. Where a first: article sample is required, b, Acceptance testine. When a first article sample has not been required, one unit shall be subjected to the performance test specified herein. passed a

26、ll testa, performance test shall not be required at: acceptance . I a test article sample has successlully 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53Li57 b5 777777Li 0030770 b i? A-A-5 3 4 5 9 T Tests Measure the Length of a stroke of t

27、he hand pump. disassemble the pump to measure the stroke area. Calculate the displacement of a single stroke and compare to specified displacement. Measure the amount of water that the collection container (with a liner in place) is capable of holding and compare with the amount specified. Sufficien

28、tly Test the vacuum gauge for range and accuracy as Specified. Measure the ID and length of the patient suction tube. Measure the ID and length of the vehicle vacuum hose. Strenuously operate the hand pump. Measure the free air flow and negative pressure and compare with specifications. Provide an e

29、xternal vacuum source in great excess to apparatus rating. Set the vacuum limiting control in accordance with instructions. Measure the free air flow and the negative pressure and compare results with limits as specified. Determine if the vacuum limiting control is functioning as specified. Metric p

30、roducts. Products manufactured to metric dimensions will be considered on an equal basis with those 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

31、 this document are met. If a product is manufactured 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 o

32、r rejecting the product. Con-tractor 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 practices. The Government reserves the right to

33、 require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. 5 ,-. . - . I Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53459 bli 9939774 0030771 8 H A-A- 5 3

34、4 5 9 Regulatory requirements. Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the oferor/contractor shall comply; and be responsible for compliance by its subcontractors/suppliers

35、, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the oferor/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements oL all other applicable Fedezal, State, an

36、d local statutes, ordinances, and regulations, Recovered materials. The offeror/contractor is encouraged to use nxovered material in accordance with Public Law 94-580, as amendedr and as implemented by Federal Acquisition RegUlatiOn Subpart: 23.4 to the maximum extent practical. Preservation, packag

37、ing, packingr labelinq, and markinq. Unless othegwise specified, preservation, packaging, and packing shall be to a degree o protection to preclude damage to containers and/or contents thereof undez normal shipping conditions, handling, etc., involving shipment from the supply source to the receivin

38、g activity, plus reshipment from receiving activity, and shalJ conform to applicable carriers rules and regulations, Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order:, NOTE: The Eollowing National. Stock Number is covered by thi

39、s document t 6515-01-061-0662 Ordering data. Intermediate/exterior package quantities, laben- maEking must be specified in the contract and/or ordec. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53459 b5 W 7497774 0030772 T A-A-5 3 459 MILIT

40、ARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 PREPARING ACTIVITY: DoD - MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4372 Locat ion: CID/SUCTION/APP/Hl2-32 7 RU. GOVERNMENT PRINTING omm ne, - 6dcsiilsu Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-