1、A-A-54043A 29 July 1991 Superseding 30 Nov 1989 - - A-A-54043 COMMERCIAL ITEM DESCRIPTION OTOSCOPE AND OPHTHALMOSCOPE SET The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a battery operated otoscope and ophthalmos
2、cope set with carrying case designed and constructed for use in the examination of the internal ear and fundus of the eye and in operating procedures of the ear. This set shall conform to the following salient characteristics: Salient Characteristics: The Set shall consist of the following component
3、s: Otoscope Head with Lamp Ophthalmoscope Head with Lamp Battepy Handle without batteries Three (3) aural specula; large, medium and small One (1) nasal speculum Two (2) replacement lamps for Otoscope Head Two (2) replacement lamps for Ophthalmoscope Head Carrying Case Instruction Manuals All lenses
4、 and filters shall be made of optical grade plastic or glass. OTOSCOPE HEAD (Open-Head construction). GENERAL Open-head style from metal (casting or machining), polished and chrome plated, or painted dull black (non-gloss). Speculum holder may swivel slightly to allow greater accessibility for instr
5、uments into the aural cavity. Attachment of a speculum to the holder shall be by friction or by positive clamping. A replaceable Lamp for illuminating the interior of the distal end of each speculum shall be located on a pedestal along the normal viewing axis at the proximal (large) opening of the s
6、peculum. AMSC N/A FSC 6515 DISTRLBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-. i A-A-54043A b5 9999974 0062257 O c .B li c-3 A-A-54043A Attachment to the battery handle s
7、hall be via a machined-metal quick-disconnect bayonet connector. This connector shall be polished and chrome plated. LAMP The Otoscope Lamp shall screw into the pedestal. It shall provide axial illumination at the distal end of the large aural speculum of not less than 210 foot candles when operated
8、 at not more than 2.70 volts. Minimum lamp life shall be 5-hours. The lamp shall be pre-centered, pre-focused, single contact and contain a closed coil filament, SPECULA The Specula shall fit snugly to the Otoscope Head to allcaw easy attachment to or removal from the Otoscope. The aural (3, 4, and
9、5 mm dia.) and nasal (9 mm dia.) specula shall be the reusable type. They shall not become distorted, cracked, or discolored when subjected to boiling and alcohol immersion. The distal ends of the specula shall not have sharp edges. The interior surfaces of the specula shall have a non-reflecting fi
10、nish to prevent glare to the operator. Materials of construction shall be nylon or polypropylene. MAGN I F I ER Each Otoscope Head shall include a magnifier lens which can be rotated into, or out of the line of sight. The magnifier shall be capable of being moved out of the line of vision to permit
11、oblique observation without magnification and insertion of surgical instruments. The magnifying lens shall furnish a magnified view of at least two diopters. The frame shallbe secured to the lamp pedestal on a stud which is parallel to the line of sight between the operator and the pedestal. The fra
12、me shall be retained in a positive manner (journal stud which screws into the pedestal, or stud with lip which is machined or cast into the body). The . magnifier assembly shall hold its position without any adjustments. This may be accomplished with spring-loading. 2 Provided by IHSNot for ResaleNo
13、 reproduction or networking permitted without license from IHS-,-,-Y I A-A-54043A 65 = 9999974 0062258 2 = “t- 4 l-p-p- A-A-54043A OPHTHALMOSCOPE HEAD. ENERAL The Ophthalmoscope Head shall have a mirror reflecting system. It shall not be necessary to manipulate any part of the Head to obtain optimum
14、 illumination, The axis of the filament image shall be fixed and essentially parallel to the upper edge of the mirror. The illuminated spot produced by the Ophthalmoscope shall be uniform and free from distortions. Attachment to the battery handle shall be via a machined-metal quick-disconnect bayon
15、et connector. This connector shall be polished and chrome plated, DIOPTER WHEEL The Ophthalmoscope Head shall have a Diopter Wheel of at least 23 lenses plus one zero aperture, mounted upon a single dial. The minimum lens range shall be from minus 35-diopters to plus 20-diopters. As an alternate, a
16、range of minus 20 to plus 40-diopters is acceptable. Each lens, when it is in the selected posi.tion, shall be identified with its numerical power, through a magnified window with internal light. APERTURE/FILTER WHEEL * The Aperture and Filter system shall contain a minimum of five different positio
17、ns: pinhole, normal aperture, clear slit, red-free filter, and either a grid or color conversion filter. Each aperture and filter shall be capable of being used with any lens selected. HOUS I Na The Ophthalmoscope Hoiising shall be plastic or metal, and shall have a dull (non-gloss) finish. It shall
18、 be designed to assure proper positioning of the Lamp with respect to the optical system. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-j A-A-54043A 65 9999974 00b2259 4 I _ A-A-54043A LAMP The Lamp base shall have a radially protruding locator p
19、in for properly positioning the Lamp in the Housing. Axial illumination provided by the Ophthalmoscope Head at a point 7-314 inches from the upper edge of the mirror shall be not less than 10 foot candles when the lamp is operated at not more than 2.70 volts. The Ophthalmoscope Lamp shall be rated a
20、t 2.5 volts at a maximum of 0.66 ampere and have a minimum life of 9-hours. The lamp shall be pre-centered, pre-focused, single contact and provide inert gas i 1 1 umi nat i on. BATTERY HANDLE. GENERAL * The Battery Handle shall mate (mechanically and electrically) with each diagnostic head. It shal
21、l be metal and suitably finished (polished and chrome plated, or anodized). It shall accommodate (2) D size batteries,.either carbon-zinc or alkaline, including Eveready E95 type. The outside of the handle on the grasping part shall be knurled or grooved. The metal connector to the heads shall be sp
22、ring-loaded, bayonet-type having a less-than-one-turn lock/stop. RHEOSTAT The Rheostat control shall be located at the top of the handle (near the connector). A detented ON-OFF switch shall be incorporated into the Rheostat housing and operating levers shall be plastic. Operation of the Rheostat sha
23、ll result in perceptable lamp dimming down to less than 80% of its maximum brightness. CARRYING CASE. ENERAL The Carrying Case shall be fabricated from either hard or soft material with hinge (6) on one side. Suitable means of closure by zipper or latch shall be provided. There shall be a form fitti
24、ng molded insert in the bottom of the Case to accommodate all the components specified in this Set. Sufficient cushioning shall be provided in the inside lid-to prevent damage to the contents if the Case is dropped 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without licens
25、e from IHS-,-,-, a 9 ! A-A-54043A 65 I 7977774 00b2260 O I . Identification marking; The ophthalmoscope head, otoscope head, and the battery handle shall be permanantly marked with the name OP registered trademark of the original manufacturer and country of origin. Markings on the carry case shall b
26、e the name or registered trademark, as a minimum. VJ4rkmanghEl The Otoscope and Ophthalmoscope set shall be free of defects which detract from its appearance or impair its serviceability. Unit. Set (SE). One otoscope and ophtfialmoscope set with carrying case, as specified, constitutes one unit. hgm
27、ngibilitx-for inspegtign, 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 use his own or any fac
28、ilities 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 supplies and services
29、 conform to prescribed requirements. Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and a made available to the Government upon the Governments request, at any time, or fram time to time, during the performance of the contract and
30、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 (determination by
31、technical means of physical and chemical properties) of the item. Tsts, Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. 5 Provided by IHSNot for ResaleNo reprodu
32、ction or networking permitted without license from IHS-,-,-. A-A-54043A 65 m 9999974 00622bL 2 m s- iI -, .-+ A-A-54043A 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 tol
33、erances 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 tolerances specified in the inch/pound units, a request should be
34、 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 meets the salient characteristics of this description and confor
35、ms to the producers own drawings, specifications, standards, and quality assurance practice=. The Clovernment reserves the right to require proof of such conformance prior to first de1ivei.y and thereafter as may be otherwise provided fop under the provisions of the contract, Reguiator_resirement-l
36、- Federal Food, Drug 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 subcontractors/suppliers, with the requirements of t
37、he 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 iequirements of all other applicable Federal, State, and local statutes, ordinance
38、s and regulations. Rgcgxgyed materials- The of feror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23,4 to the maximum extent practical. oreserxatLonl-Eackaging-acng-g-mkn Unless otherwise specified, preservation, packaging, and packing
39、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 receiving activity, and shall conform to applicable carriers rules
40、and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. e A Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1 A-A-54043A b5 m 9999974 00b22b2 4 =I l A-A-54043A Orderin
41、g-gata. (Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. 1 NOTE: The following National Stock Number is covered by this document. ITEM IDENTIFICATION - 65 15 - 0.0 - 550 -7 199 OTOSCOPE AND OPHTHALMOSCOPE SET MILITARY INTERESTS: Army - MD Navy - MS Air Force CIVIL AGENCY - 03 COORDINATING ACTIVITIES: PREPARINU ACTIVITY! DoD-M Agent: DLA-DM VA-OSS PHS FDA-MPQAS Project Number: 6515-5104 Location: ENABLE/OTOSCCID/SSC Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
