1、A-A-540 38 30 March 1990 COMMERCIAL ITEM DESCRIPTION SUCTION APPARATUS, OROPHARYNGEAL, TRACHEAL Fortable, Battery Operated, (Aeromedical) The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a fully integrated, batter
2、y operated, portable oropharyngeal, tracheal suction apparatus, with EMI/RFI suppression, self contained in a carrying case. Salient characteristics: The suction apparatus shall be a portable, self-contained, oropharyngeal/tracheal suction apparatus with EM1 andRFI suppressed circuitry. It shall be
3、ready for immediate use, as received, without the use of tools. It shall include the following items: a. Rechargeable power pack with controls and rechargeable batteries. b. Battery charger. c. Motor and pump. d. EMI/RFI suppression circuitry. e. A two speed selector control. f. Vehicle electric cor
4、d, minimum 6 feet long. g. Vacuum bottle, 600 ml minimum. h. Suction tubing, minimum 45 inches long. i. Operating instructions and other documentation. j. Carrying case. The suction apparatus shall be suitable for use in aspiKating secretions, blood, or vomitis in emergency treatment of unconscious
5、or injured personnel in desert, tropic, arctic, or aeromedical environments. msc N/A FSC 6515 distribution is unlimited. DISTRIBUTION STATEMENT A. Approved for public release; Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54038 65 m 777777q 005
6、 A-A-5403 8 The apparatus shall include controls to select power on/off and low/high speed; indicating lamps for power on and battery charger on; circuit breaker/fuse to protect motor from overload; adjustable vacuum valve to regulate maximum vacuum; and gauge to indicate actual vacuum level. The ap
7、paratus shall not include an automatic shut-off. The design of the motor-pump shall be such that overflow of patient debris shall not clog or jam it during use and it shall be readily cleanable. The apparatus shall operate from its internal batteries (power pack), an external 12 VDC 120 amp-hour hea
8、vy-duty vehicle battery, and any 5 amp DC service with voltage within range of 12 to 15 volts. The dual power source battery charging circuit shall be capable of accepting input power from a vehicle generating system rated 120 amperes for 12 volt system, vehicle 12 volt battery and an AC system of 1
9、15 volt, 50/60/400 Hz. The collection container and tubing shall be sterilizable by ethylene oxide gas or disinfected by cold sterilizing solution. Shall be easily removable without tools for emptying and cleaning. The complete suction apparatus shall be housed in a rigid or semi- rigid, flame retar
10、dant, mildew resistant, plastic case with handle(s), hinge and closure latches. permanently marked as follows: It shall provide user/maintenance manuals (2) which will meet as a minimum ASTM F 960 requirements. The complete apparatus in its carrying case, less the above mentioned manuals, shall not
11、weigh more than 20 pounds. The dimensions of the carrying case shall not exceed 20 inches by 15 inches by 12 inches high. The suction apparatus shall meet the performance requirements listed in this specification. The top of the case shall be EMI/RFI Filtered for Aeromedical 2 Provided by IHSNot for
12、 ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54034 65 7777774 0053770 O W A-A-5 4 O 3 8 Performance requirements: Characteristic Performance a. Minimum suction capacity. 500 mm Hg b. Operating temperature range. from (-)4OF to (+)1150F c. Recharge time 24 hours, AC
13、/DC sources d. Free airflow at patient end 30 LPM minimum on high speed, speed . of suction tube and 13.5 minimum on low e. Run time (four tests: 60 minutes minimum at low two requirements, one speed while moving a minimum per extreme of ambient of 13.5 LPM (both temperature temperature requirement)
14、 extremes) 35 minutes minimum for both high and low speed. at maximum speed while moving Free airflow at patient end of a minimum of 30 LPM. suction tube. f. Collection container minimum 600 ml minimum The apparatus shall meet the requirements of ASTM F-960 excluding the sections dealing with filter
15、s and pleural/closed wound drainage vessels. It shall also meet the leakage current requirements of UL and CSA. O capacity Workmanship. The suction apparatus shall be free from defects which detract from its appearance or impair its serviceability. Unit. Each (EA). One suction apparatus along with t
16、wo sets of operating and maintenance manuals, as specified, constitutes one unit. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-sm_l_ I- A-A-54038 b5 A-A-540 38 Quality Assurance Provisions. Responsibility for Inspection. Unless otherwise specifi
17、ed 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 contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection
18、 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 inspections are deemed necessary to assure supplies and services conform to prescribed requirements. * Records. Records
19、 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 after delivery of the suppl
20、ies to which such records relate. Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the
21、 item. O Samplincr for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with a AQL of 2.5 (percent defective) and an inspection level of S-1. The unit of product for examination purposes shall be one suction apparatus, as specified in this description. 4 Provi
22、ded by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 5 40 3 Sampling for tests. Sampling for tests, including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and an inspection level of S-2 The un
23、it of product for test purposes shall be one suction apparatus. First article. Two first article samples are required; the first dedicated solely for EMI/RFI testing, the second for all other testing required by this specification. performance requirements herein and in accordance with test requirem
24、ents in ASTM F960. used for the determination of two or more test characteristics. 0 Tests. Tests shall be performed to assure compliance with Where feasible, the same sample shall be Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufact
25、ured 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. If a product is manufactured to metric dimensions and those dimensions exceed the to
26、lerances 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. The contractor shall certify that the product offered mee
27、ts 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 require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for un
28、der the provisions of the contract. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-_p_I_ I_ A-A-54038 b5 W 7777774 0053773 b A-A-54 038 Requlatory requirements. If the product covered by this document has been determined by the U.S. Food and Drug
29、Administration to be under its jurisdiction, the offeror/contractor 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,
30、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 recovered material in accordance with Public Law 94-580,
31、as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, packinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers
32、 and/or contents thereof under normal shipping conditions, handling, etct, involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. package quantities and labeling and marking shall b
33、e as specified in the contract and/or order. Federal Food, Drug and Cosmetic Act. In addition, the Intermediate and exterior 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
34、umber is covered by this 6515-01-284-8704 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- MILITARY INTERESTS: A-A-540 38 PREPARING ACTIVITY: DOD - MB Custodians: Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4653 Location: CID/SUCTION/APPAR/ORPHO/TRAC/H-lD-35 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
