DOD A-A-54334-1991 CELL WASHING SYSTEM《单元洗涤系统》.pdf

1、a- A-A-54334 66 9999974 0060225 T = A-A- 54334 4 Fabruary 1991 COMMERCIAL ITEM DESCRIPTION CELL WASHING SYSTEM The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a blood cell washing system for deglycerolizing thawe

2、d red blood cells. Shall be a blood cell washing system for deglycerolizing thawed red blood cells by a sequential dilution method. Shall be a gravity fed continuous flow type red blood cell washing system suitable for high glycerol freezing protocols. Shall be suitable for operation from 50/60 Hz A

3、C supply lines. The applicable rated line voltage shall be as indicated in the contract and/or purchase order (see “Ordering data paragraph). Shall include a cabinet housing with a pole stand. The pole stand shall have a 45 inch minimum height and shall include four (4) height adjustable support hoo

4、ks that are suitable for suspending plastic type IV solution bags. Shall have the cabinet housing designed and constructed to include the following: A fixed speed centrifuge designed to accommodate an inserted washbowl that is a component of the wachbowl/wacte bag set. The centrifuge shall operate a

5、t a speed of 5850 rpm 1: 125 rpm. A top mounted oscillating mixing platform with four (4) adjustable magnetic mounting posts that include mounting pins. The mixing platform shall operate with a oscillation rate of 180 cycles/minute 2 3 cyc-lesiminute. The magnetic mounting posts shall be adjuutable

6、for securing a primary collection bag (i.e. unit containing glycerolized red blood cells) to the mixing platform. Electrical controls for activating and deactivating the mixing platform and centrifuge. AMSC N/A FSC 6640 DISTRIBUTION STATEMENT Ai Approved for public release; distribution is unlimited

7、. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54334 bb R 9999974 00b022b I = A- A-54334 t A cooling fan that operates whenever .the mixing platform and centrifuge are in operation. A 30 minute mechanical timer with audio alarm that is graduat

8、ed in one (1) minute intervals. The timer shall be used for indicating when a preset time had Seen reached, without controlling any component of the blood cell washing system. Mounting pins that are secui*ed to the side of the housing, for mounting a 6000 milliliter (ml) capacity waste bag that is a

9、 component of the washbowl/waste bag set. Suitable fittings for supporting an inserted pole stand in an upright position. Shall be suitable for use with a disposable plastic washbowl/waste bag set (not required to be supplied with the blood cell washer) with the following characteristics: Consists o

10、f a centrifuge bowl with inlet and outlet port connectors, an integrally attached cell wash harness, and a detachable 6000 ml capacity waste bag,-. The cell wash harness consists of various lengths of plastic tubing, four (4) “Y“ type connectors, and a four (4) color spike harness (i.e. with a yello

11、w, a blue, and 2 red color coded spike terminations). The yellow color spike intended for connection to a 3000 ml capacity container with a 0.9% saline/0.2% dextrose solution. The blue color spike intended for connection to a 150 ml capacity container with a 12% saline solution. The red color spikes

12、 intended for connection to two (2) primary collection bags containing glycerolized red blood cells. The wash solution perfuses the red blood cells in the spinning washbowl, and then exits separately through the outlet port of the washbowl into the waste bag for disposal. The washed unit of red bloo

13、d cells is siphoned from the washbowl into a blood recovery pack that is suspended from a support hook on the pole stand. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-t I I I I 0 I l I l II A-A-54334 bb 9999974 OOb0227 3 M A-A-54334 6 WgrkFanshi

14、E- The blood cell washer shall be free from defects which detract from its appearance or impair its serviceability. Enii1 Each (EA). One blood cell washer, as specified, constitutes one unit. hgpgosibilj&y-ggy inspgction, Unless otherwise specified in the contract or purchase order, the contractor i

15、s 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, unless disapproved by

16、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 of examinations and tests performed by or for the contra

17、ctor 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 supplies to which such records relate. - InsEection. - Inspect

18、ion, 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 item. _-_ Insgections - and testing. Inspections and

19、 testing shall be conducted on the blood cell washer in accordance with commercial practice. Sampling for the inspections and testing shall be in accordance with commercial practice. In addition, each blood cell washer shall be tested to demonstrate its capability for proper operation. The testing s

20、hall check for the proper operation of the electric controls, centrifuge, mixing platform and cooling fan. Any component that does not operate properly shall be cause for rejection of the blood cell washer. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from I

21、HS-,-,-A-A-54334 bb - 9999974 0060228 5 A-A- 54334 _-_-_ 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 conversion tables contained in the la

22、test 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 inchpound units, a request should be made to the contracting officer to determine if the product i

23、s acceptable. The contracting officer has the option of accepting or rejecting the product. . Contractor 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, a

24、nd 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 provisions of the contract. Federal Food, Drug-gcd Cosmetic Act. If the product covered by this document has been d

25、etermined by the U.S. Food and Drug Administration to be under its jurisdiction, the offerorcontractor 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

26、. In addition, the offeror/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 reco

27、vered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the mximum extent practical. - Preservation,_Eackaging,_Eackng,_labell- Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or content

28、s 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 regulations. Intermediate and exterior package quantities and labeling and mark

29、ing shall be as specified in the contract and/or order. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54334 66 qqqqq74 0060227 7 A-8-54334 NOTE: The following National Stock Numbers are covered by this document. 6640-01-235-6131 6640-01-315-8

30、452 Ordering data. (Applicable line voltage intermediate/exterior package quantities, labeling, and marking must be specified .in the contract and/or order.) MILITARY INTERESTS: Army - MD Navy - MS Air Force - 03 PREPARING ACTIVITY: DoD-MB Agent: DLA-DM CIVIL AGENCY COORDINATINCI ACTIVITIES: VA-OSS PHS FDA-MPQAS Project Number: 6640-1651 Location: ENABLE/BLOODCID/S31 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-