DOD A-A-54889-1993 BLOOD FLUID WARMER AND PRESSURE INFUSION SYSTEM《血液流动温热装置和压力灌输系统》.pdf

1、A-A-549 9999974 0345304 414 I INCH-POUND 1 A-A-54 0 09 23 July 1993 COMMERCIAL ITEM DESCRIPTION BLOOD FLUID WARMER AND PRESSURE INFUSION SYSTEM The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a blood-fluid warmer

2、 and pressure infusion system for trauma and massive fluid replacement. Salient characteristics: The unit shall be a fluid management system for trauma and massive fluid replacement. It shall provide blood and IV fluid warming plus high speed infusion. It shall be able to mount completely to an IV p

3、ole. The unit shall warm cold blood to normothermic temperature at flow rates up to at least 450 ml/minute and physiological fluids at flow rates up to at least 750 ml/minute. The system shall consist of: 1. A fluid reservoir and warmer that maintains circulating water temperature of 4OoC plus or mi

4、nus 0.2OC, alarms and displays for maintaining proper water temperature and level, and an automatic high temperature shut off at 4 loC. 2. A pressure infusion system with two pressure chambers that accept both 500 ml or 1000 ml fluid bags, and a built-in compressor. The system shall allow for fast,

5、easy, disposable Set-up, shall have an alarm that signals improperly installed disposables, and shall not function unless disposables are properly installed. AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproducti

6、on or networking permitted without license from IHS-,-,-A-A-54889 9999974 0145305 350 A-A- 5 4 a a 9 The system, excluding pressure chambers, shall not exceed 40 inches in height, 6 inches in width, and 7 inches in depth. Weight shall not exceed 20 pounds. The system shall function from 115 VAC, 50/

7、60 Hz electrical supplies. Workmanship. The blood-fluid warmer and pressure infusion system shall be free from defects which detract from its appearance or impair its serviceability. Unit. Each (EA). One blood fluid warmer and pressure infusion system, as specified, constitutes one unit. Oualitv Ass

8、urance 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 contract or purchase order, the contractor may us

9、e 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 inspections are deemed necessary to assure sup

10、plies and services conform to prescribed requirements. 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 t

11、he contract and for a period of three years after delivery of the supplies 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 (deter

12、mination by technical means of physical and chemical properties) of the item. Samplinq for examination. Sampling for examination shall be conducted in accordance with MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of S-2. The unit of product for examination purposes shal

13、l be one blood-fluid warmer and pressure infusion system. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54889 9999974 0145306 297 A-A- 5 4 a a 9 Samplinq for tests. Sampling for tests, including dimensional test, shall be conducted in accorda

14、nce with MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of S-2. The unit of product for test purposes shall be one blood-fluid warmer and pressure infusion system. O Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible,

15、the same sample shall be used for the determination of two or more test characteristics. Tests shall include, but shall not be limited to, the following: * Maximum flow rate of blood for one minute shall measure at least 450 ml, and for physiological fluid at least 750 ml. * Circulatina water temDer

16、ature shall measure 4OoC, plus or minus 0.2OC. 4 loC. High temperatkre shut off shall operate at Metric products. 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

17、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 tolerances specified in the inch/pound units, a request should be made to the contracting

18、 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 and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial

19、Item Description, and that the product 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 under the provisio

20、ns of the contract. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54&9 m 9999974 0345307 123 m A-A- 5 4 88 9 Requlatory requirements. Federal Food, Drus and Cosmetic Act. If the product covered by this document has been determined by the U.S.

21、 Food and Drug 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. In addition, the o

22、fferor/contractor shall comply, 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 acc

23、ordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, p ackinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents the

24、reof 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 regulations. Intermediate and exterior package quantities and labeling and marking s

25、hall be as specified in the contract and/or order. Orderinq data. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. NOTES: 1. This system is intended to be fully compatible with a full range of sterile blood and fluid warming disposable s

26、ets: Disposable Set “ Blood/Fluid Administration Set 6515-01-344-6612 Blood/Fluid Administration Set 6515-01-334-0853 Blood/Fluid Administration Set 6515-01-344-6106 Filter Air Eliminator for D-50/100 6515-01-334-0855 Pre-Filter 6515-01-334-0a56 High-Flow Injection Port and Extension 6515-01-344-524

27、9 High-Flow Extension Y-Type 6515-01-334-0854 Extension Line 6515-01-344-5255 Irrigating Set 6515-01-344-5254 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54889 9999974 0345308 ObT A-A-54 889 Plus the following patient rewarming disposable s

28、ystem: Arterial to Venous Rewarming set, capable of rewarming cold patients at rates up to 1 C every 15 minutes. 2. The following National Stock Number is covered by this doc Ume n t. e 6515-01-370-5019 MILITARY INTERESTS: Custodians: Air Force - 03 Army - MD Navy - MS PREPARING ACTIVITY: DoD-MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: FDA-MPQAS USPHS VA - OSS Project Number: 6515-5620 Location: WARMR17C.DOC 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-