DOD A-A-51371-1986 RESUSCITATOR AND ASPIRATOR《呼吸器及人工呼吸器》.pdf

1、!ME TEM D A-A-51371 31 March 1986 PTION RESUSCITATOR AND ASPIRATOR The General Services Administration has authorized the use of this commercial item description. This comercial item description covers a portable rescue breathing set and shall include a hand-operated resuscitator, a foot-operated as

2、pirator and a carrying case. Shall be for use by medical personnel during emergency resuscitation of humans. Salient characeristics: Material and description. The resuscitator shall be designed for hand-operation and shall have the capability to administer either of both air and enriched oxygen conc

3、entrations, to re-establish and assist normal breathing during respiratory emergencies occurring in a wide range of climatic conditions. The resuscifator assembly shall include a self-filling compressible butyl rubber or silicon bag. liters, and shall be designed to control bag recovery, and shall b

4、e designed/shaped for single hand support/pump operation. The proximal end of the bag shall be fitted with a non-rebreathing patient valve that is contained in a suitable plastic housing having a standard 15/22 mn con- nector at the patient end which is in accordance with ANSI 279.8. The distal end

5、of the bag.shal1 be fitted with an adapter ring that shall be connectable to the manufacturers optional accumulator. The adapter ring shall include a check valve inlet and a nipple for connection of a low pressure oxygen tube. The valve shall be capable of admitting either ambient air or oxygen enri

6、ched air. The nipple shall not provide a direct path into the bag. It shall have a side outlet for oxygen to mix with air inside the adapter ring in proximity of the inlet valve. The complete adapter ring shall be capable of enriching the oxygen concentration of the air just prior to admission into

7、the bag. The resuscitator shall also include a reusable medium adult size face mask that shall consist of a suitable face seal, a suitably transparent front section which allows visual monitoring of patient breath content, and a connector. connector shall be compatible with the bag connector and sta

8、ndard adapters specified in ANSI 279.2 and 279.6. - The bag shall have a minimum volume capacity of 1.6 The The foot-operated aspirator assembly shall have the capacity to remove secretions from the patients airway to enable successful resuscitation efforts. The aspirator shall effectively function

9、with an overflowing collection jar. The assembly shall be supported on a base that allows either foot or hand operation. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. THIS DOCUMENT CONTAINS -.- Instructions. Dperation, operating instructions, ass

10、embly/disassembly instructions, a list of replacement parts by manufacturers catalog number, descriptive sketches as appro- ,riate, statement of warranty, and manufacturers and distributors names, iddresses, and phone numbers. The carrying case shall contain manual(s) describing the theory of dorkma

11、nship. From its appearance or impair its serviceability. The rescue breathing set shall be free from defects which detract Inspection. The contractor,shall perform adequate inspection to assure compliance with this Description. any of the inspections set forth herein. A lot shall be any group of uni

12、ts from which the Government selects samples for inspection. The contractor shall be responsible for maintaining a quality assurance program and shall be responsible to replace/repair any and all defective units, or lots of units that equal or exceed 2.5 percent defective units, that are rejected by

13、 the Government. Visual examinations that do not require the use of special laboratory appliance/procedure shall not be restricted to defects listed herein. Test determination by technical means of physical and chemical properties of the item characteristics shall be as 1 isted under “Tests: II. The

14、 government reserves the right to perform 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Visual examination. O 1. Component missing or not as specified. 2. checking, breaks, and deformed areas of the collection containers, and/or tubing. 3. Unit n

15、ot clean. 4. 5. 6. 7. Service data not included. 8. Identification marking missing, incomplete, illegible, or not properly attached. 9. Aspirator not operable while in carrying case when case is opened, and patient end of suction tube is withdrawn from case, and no other action taken by the user/ins

16、pector. Component not free of including (but not restricted to) cracks, Collection container not readily removable. Blistering, checking, peeling, scratching, or bare areas of the finish. Any screw not drawn up tight; rivet not properly installed. 10. Metal parts not free of corrosion. Tests: Draina

17、ge bottle. The drainage bottle shall be subjected to an internal vacuum of 12 inches - + 20 percent of Hg for a period of one (1) minute without fail Ure. O Drop test. The unit, with all components inserted in place within the case, shall be dropped from a height of 18 inches onto dry earth. shall n

18、ot open and components shall not be damaged or dislodged from their proper location within the case. Water resistance. The unit, in its case (case closed in upright position, shall be subjected to a shower at the rate of 3 inches per hour for a period of 5 minutes, The contents shall be examined to

19、determine if moisture has entered the case. Humidity. The case At a relative humidity of 95 + 5 percgnt, cycle the unit as Then test the unit for performance as follows: Raise temperature linearly from 80FT to 115 F. in 6 hours; maintain at lZooF. for 6 hours; decrease temperature linearly from 12Oo

20、F. to 80O. in 6 hours ,maintain at 80OF. for 6 hours, specified hereunder after a 1/2 minute operating time, Performance, The unit (in its case) shall be placed on a level surface and operated in accordance with the manufacturers instructions (which shall be included in the carrying case). after ope

21、rating at least 1/2 minute: The following determinations shall be made Vacuum at bellows end of patient tube shall be as specified. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-51371 i i a i L . Insert patient end of the tube in water and co

22、ntinue to pump until after water is overflowing. There shall still be a negative pressure at the patient end of the tube uhile pumping and water is overflowing. container and have back in operation, allowing a maximum of 15 seconds from last stroke before emptying to first stroke after emptying. Fol

23、lowing the manufacturers instructions, empty the full collection Resuscitator Performanceb Each test herein shall be performed twice, once in ambient temperature for 5 F. (+So) and humidity-of 10 percent (+5 percent) after standing in 5OF. temperature for 3 hours, and once in ambien temperature Of l

24、5OF. (+So) and humidity of 90 percent (+5 percent) after standing in 1150F temperature for 3 hours. - A single one-handed pump stroke shall displace the volume of air as specified. The bag shall fully recover to its relaxed size and shape in not more than 1 second upon being released from the above

25、stroke. While being operated at a rate to produce an airflow of 15 LPM, a running test of valve ports pressure/negative pressure shall determine that the non-rebreathing valve does not allow rebreathing of exhausted air directly from the bag, and that all valves are operating smoothly and as intende

26、d. . The unit shall be operated in conjunction with an oxygen source. The unit shall be fully disassembled. The low Attempts shall be made to assemble No part shall be capable of assembly in a wrong location and high supplementary oxygen concentration shall be as specified. the unit incorrectly. or

27、incorrectly at its proper location The unit shall be measured and weighed to verify conformance with specifications. Aging. Durability test shall be performed as specified, Unit. Each (EA), unit. One rescue breathing set, as specified, constitutes one Contractor certification. The contractor shall c

28、ertify that the product offered meets the salient characteristics of this description 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 delivery and thereafter as m

29、ay be otherwise provided for under the provisions of the contract. The Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-51371 Regu 1 atory requirements , Federal Food, Drug and Cosmetic Act has been determined by the U. S. Food and Drug Administra

30、tion to be under its jur sdiction , the offeror/contractor chal 1 comply, and be responsible for compliance by ts subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. the offeror/contractor shall comply, and b

31、e responsible for compliance by its subcontractors/suppl iers, with the requirements of al 1 other applicable Federal, State, and local statutes, ordinances, and regulations. If the product covered by this document In addition, Recovered materials. The offeror/contractor is encouraged to use recover

32、ed material in accordance with Public Law 94-580 to the maximum extent practical. Preservation, packaging, packing, labeling, and marking. preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions

33、, hand1 ing, 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. marking shall be as specified in the contract and/or order. NOTE: The following National Stock Number is co

34、vered by this document: Unless otherwise specified, Intermediate and exterior package quantities and labeling and O 6515-00-890-1818 Ordering data, must be specified in the contract and/or order. Intermediate/exterior package quantities and labeling and marking MILITARY INTERESTS: Custodians : Amy - MD Navy - MS Air Force - 03 CIVIL AGENCY COORDINATING ACTIVITY: VA - OSS PREPARING ACTIVITY: DoD - MB Agent: DLA - DM Project No. 6515-3547 Locat ion: H1-18-43 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-