DOD A-A-54864-1993 BRONCHOSCOPE FLEXIBLE FIBER OPTIC TRANSNASAL OR TRANSORAL《鼻或口头光纤柔软气管镜》.pdf

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1、mL r A-A-548b4 9999974 0144343 405 I METRIC I 15 May 1993 A-A-5 4 8 6 4 COMMERCIAL ITEM DESCRIPTION BRONCHOSCOPE, Flexible, Fiber Optic, Transnasal or Transoral The General Services Administration has authorized the use of this commercial item description. This commercial item description covers a b

2、ronchoscope with the following salient characteristics: Salient characteristics: The instrument shall be a 5 millimeter (mm) flexible fiberoptic bronchoscope specifically designed for either transoral or transnasal passage in diagnostic and therapeutic exploration of the bronchial tree. The bronchos

3、cope shall be supplied with the following components and their respective quantities: Component Quantity 4.8 Fr biopsy specimen forceps Disposable cytology brushes Bite protector Cleaning brush Operating/maintenance manuals Carrying case Diaphragm seals Eyepiece cover and rubber eyeguard 1 Features.

4、 The bronchoscope shall have the following design and performance features. The bronchoscope shall have a 5.0 mm maxiriiuin tip diameter, an outside shaft diameter of 4.9 mm to 5.3 nun, a working length of approximately 55 centimeter (cm), and a biopsy channel diameter of 2.00 +/- 0.2 mm. tip shall

5、be approximately 4.8 mm allowing for deep atraumatic entry into subsegmental bronchial areas. The extreme distal diameter of the deflecting AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: distribution is unlimited. Approved for public release; O Provided by IHSNot for ResaleNo reproduction or networking

6、 permitted without license from IHS-,-,-A-A-5 48 64 9999974 0344344 343 *y - i: A-A-54 864 The instrument shall have a deflection control knob conveniently located on the scope body distal to the eyepiece. The deflecting section shall have an approximate length of 32 mm with a bend radius of approxi

7、mately 10 mm. The instrument shall feature a total deflection range of 220 degrees minimum, 160 degrees minimum upward deflection span and 60 degrees minimum downward deflection span. The instrument shall have a fiber optic image bundle producing large, bright, sharp images. The bundle shall be atta

8、ched to the scope just distal to the eyepiece. This bundle shall be a minimum of 1.5 meters in length with an integral bakelite type connecting end that securely attaches into a light source (see Note 2). The extreme distal tip of the bundle shall be protected with a heat shield to protect the bundl

9、e from separation. The bronchoscope shall have a 67 degree minimum optical field of view and shall feature forward vision and fixed focus optical properties. The optical bundle shall have a 16X minimum magnification through the eyepiece and the instrument shall have a depth of field of 5.0 mm to 50

10、nun. The instrument shall feature a +2 to -8 diopter ocular adjustment. The bronchoscope shall feature an automatic aspirator for lavage, aspiration, and introduction of medication with and without the forceps in place. 2.0 mm +/- .2 mm operating channel for biopsy, medication, lavage, suction and l

11、ocal anesthesia. The component biopsy forceps and the disposable cytology brushes shall easily pass through the 2.0 +/- .2 mm channel even when the distal tip deflected 90 degree. The bronchoscope shall have a Accessories. The biopsy forceps shall be flexible with a double acting design for taking a

12、dequate specimens with minimum chance of bleeding. shall have a 1.6 mm diameter and a nominal working length of 101 em. control . The 4.8 French biopsy forceps The forceps shall be designed with a finger ring The cytology brushes shall have flexible shafts consisting of tightly twisted stainless ste

13、el wires. The plastic brush sheaths shall be free of cuts, nicks or imperfections. The brushes shall be designed with a finger ring control for ease in insertion and removal. The extreme distal tip shall be rounded to prevent inadvertent damage to tissues. The brush segments on the distal end shall

14、be tightly woven into the twisted steel shaft preventing inadvertent separation during use. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54b4 m 9999974 OI144145 288 m A-A- 5 4 8 6 4 The bite protectors shall be of molded plastic with a centr

15、al hole for introduction of the bronchoscope. The instrument shall come with a heavily padded “brief case style“ case of sufficient size to contain the bronchoscope and all component parts. Materiel. The body of the bronchoscope shall be fabricated of high impact plastic for strength and comfort. Th

16、e metal portions of the bronchoscope shall be fabricated of a suitable corrosion resisting steel. Style, deciqn and dimensions. The bronchoscope shall be in accordance with Figure 1 in this specification for style, design and dimensions. Passivation. be properly hardened and passivated as a final op

17、eration. Sterilization. withstanding ethylene oxide sterilization up to 140F. bronchoscope shall be completely immersible for cleaning and disinfection. The metal components of the bronchoscope shall The bronchoscope shall be capable of The Workmanship. The bronchoscope shall be free from defects wh

18、ich detract from its appearance or impair its serviceability. Unit. Each (EA). One bronchoscope with accessories as specified, constitutes one unit. QUALITY ASSURANCE PROVISIONS. Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsibl

19、e for the performance of all inspection requirements as specified herein. purchase order, the contractor may use 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

20、any of the inspections set forth in specification where such inspection are deemed necessary to assure supplies and services conform to prescribed requirements. Except as otherwise specified in the contract or 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license fro

21、m IHS-,-,-A-A-5 48 64 m 9999974 014414b 114 m A-A-5 4 a 6 4 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

22、 of the contract and for a period of three years after delivery of the supplies to which such records relate. InsDection. 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 (

23、determination 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 and as specified herein. Unit of product for examination purposes shall be one bronchoscope as specified. Sampling s

24、hall be inspection level II with an Acceptable Quality Level (AQL) of 1.0. compliance with specification requirements. Examination. Examination shall be conducted to determine Samplinq for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of pr

25、oduct for test purposes shall be one bronchoscope. Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for determination of two or more test characteristics. Metric Products. Products manufactured to metric dimensions

26、 will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the latest revision of Federal Standard No. 376, and all other requirements of this document are met. If a product is manufact

27、ured 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 or rejecting the product. 4 Provided by IHSNot fo

28、r ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54864 = 9999974 0144147 050 = A-A-54 8 64 Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item De

29、scription, 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 provisions of t

30、he contract. O Requlatory requirements. Federal Food, Drus, 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 offeror/contractor shall comply, and be responsible for compliance by its subcontractor

31、s/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federa

32、l, State, and local statutes, ordinances, and regulations. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaqinq, D ackinq, labelinq, and markinq. Unl

33、ess otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment from the supply source to the receiving activity, plus reshipment from receiv

34、ing activity and shall 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. Orderins data. labeling and marking must be specified in the contract and/or order . Intermediate/ext

35、erior package quantities and 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-548b4 W 9999974 0144148 T7 A-A-5 4 8 6 4 NOTE 1: Item Identification is covered by this document: The following Nacional Stock Number and its respective NATIONAL STOCK

36、 NUMBER ITEM IDENTIFICATION 6515-01-173-7054 BRONCHOSCOPE, Flexible, Fiberoptic, Transnasal, Transoral, 58 cm, 220 Minimum Degree Tip, Deflection, 16X Minimum Magnification, 1.8 mm Channel. NOTE 2: respective Item identifications are to be used in conjunction The following National Stock Numbers and

37、 their ITEM IDENTIFICATION LIGHT, Endoscopic Instrument, Fiber Optic LIGHT, Endoscopic Instyument, Fiber Optic with this item: NATIONAL STOCK NUMBER 6515-01-153-9649 6515-01-181-8711 MILITARY INTERESTS: Custodians: Army - MD Navy - MS Air Force - 03 CIVIL AGENCY COORDI VA-OSS USPHS FDA-MPQAS Prepari

38、ng Activity: DOD-MB Agent: DLA-DM JG ACTIVITIES : Project Number: 6515-5454 Location: c:wordericbronscop 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-4-5 4864 n “. , r I: -1 ! J l I t- t U E L I- i- - G Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-