DOD A-A-54044-1989 TONOMETER OPHTHALMIC SCHIOTZ《眼科张力计》.pdf

1、A-A-54044 65 7777774 0033357 A-A-54044 30 Nov 1989 COMMERCIAL ITEM DESCRIPTION TONOMETER, OPHTHALMIC, SCHIOTZ The General Services Administration has authorized the use of this Commercial Item Description to replace Federal Specification GG-T-585B which is being cancelled. This commercial item descr

2、iption covers a mechanical tonometer suitable or measuring intraocular pressure. Salient characteristics: General. The tonometer furnished under this document shall be of Schiotz design using no electrical power. Scale reading is obtained in proportion to the cornea pressure. Weights are added to th

3、e instrument for expanding the scale range. Materials. Frame. Aluminum alloy No. 2024 or No. 6061. All temper-ed for the purpose intended. Scale Support. Etched aluminum alloy. Pointer. Spring steel or hard-drawn stainless steel. Scale. Permanently printed on a plastic strip. Remainder components. B

4、right chrome plated over brass. Case. High impact resistant material. Form fitting pad or molded insert. AMSC N/A FSC 6540 DISTRIBUTION STATEMENT A. Approved for public release; distribution O is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS

5、-,-,-A-A-54 O 4 4 Style, design and dimensions. The mechanical tonometer shall be Schiotz design as approved by the Committee on Standardization of Tonometers of the American Academy of O?hthalmoogy and Otolaryngology. The instrument shail consist of a rigid housing having a liinited vertical motion

6、 within the retaining handle. There shall be a freely-moving plunger within the housing. This plunger shall carry weight or weights as described hereinafter, and shall transmit its vertical motion to a pointer by means of a lever. The motion so transmitted shall be measured by means of a scale locat

7、ed at the top of the instrument and over which the pointer shall pass. least -1 to at least 715 in one unit steps. The scale shall be graduated from at Weights. Four weights shall be supplied with the instrument. One weight marked “5.5“ shall be secured to the plunger by clipping action. The other t

8、hree weights shall be furnished: one 2-gm. weight marked “7.5“, one 4.5-gm weight marked irlO“, and one y.5-grn weight marked “15“. The weights shall each have a tolerance of + 0.02 gm. These weights shall be put on or off easily yet they-shall be secured to the shaft. Dimensions. Dimensions shall b

9、e in accordance with the specification 5 or latest edition for tonometer, as published by the Committee on Standardization of Tononmeters of the American Academy o Ophthalomology and Otolaryngology. Where dimensional requirements contained in this specification are in confiict with the committees la

10、test specification, the latter specification shall govern, Dimensions are given in milimeters imm). Footplate Diameter Radius of concavity Diameter of Footplate hole -i- 0.2 -i- 0.25 3.7 - 0.5 10.1 - 15.0 - Plunger Diameter 3.0 - -i- 0.03 + 0.75 Radius of concavity of base 15.0 - . Extension of plun

11、ger below spherical surface of footplate 3 maximum Pointer Depth Thickness Distance between scale and point er 3 maximum 0.25 maximum 1.0 maximum 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-54044 65 7777774 OOL3LbL b m, A-A-54 04 4 Hammer

12、Plunger contact with hammer smooth, free from . pits throughout usable scale - Scale. Each scale unit shall equal 0.050 mm of plunger displacement. The tonometer scale shall extend from -1.0 at least + 15.0 in 1 mm increments. A test block shall be supplied in the case with each tonometer. The tonom

13、eter when resting on the convex surface of the test block shall give -a reading of 0.00 + 0.15. The scale shall be calibrated so that the plunger displacement in mm from -1.0 scale reading shall be as follows: Scale Reading Plunger Displacement 5.0 10.0 15.0 0.30 + 0.01 0.55 t 0.015 0.80 T - 0.03 Fi

14、nish. The finish shall be mirror, or mirror and satin, except the pointer, which shall be given a blue or black finish. As an alternate, frame shall be fine sandblasted and anodized. Finish shall be such that it will not chip. Chart. A chart converting scale units to mm of mercury shall be furnished

15、 with each instrument in printed form. a Case. Each instrument shall be provided with a molded insert or lined case suitably fitted to securely retain the instrument and accessories. Outside dimensions of the case shall not exceed 6-1/2 X 4-1/4 X 1-3/16 inches. Identification marking. Each instrumen

16、t shall be permanently and legibly marked with the manufacturers name or trademark of such known character that the source of manufacture may be readily determined. Serial number shall be marked on the scale support. Instructions or Disinfecting and Cleaning Mechanical cleaning mechanical tonometers

17、 as approved by the Committee on Standardization of Tonometers of the American Academy of into each instrument case: v Tonometers. The following instructions for disinfecting and . Ophthalmology and Otolaryngology shall be furnished and packed z a -. 3 Provided by IHSNot for ResaleNo reproduction or

18、 networking permitted without license from IHS-,-,-A-Am54 04 4 Disinfection. In order to avoid the transference of infectious bacteria or viruses from one patient to another, the end of the mechanical tonometer coming in contact with the eye shall be Chloride Solution (U.S.P.1 so that the mechanical

19、 tonometer footplate and plunger remain immersed in this disinfecting solution during the period of day in which the tonometer is in use. The instrument shall not be left in the disinfecting solution overnight. Since the disinfectant may be slightly irritating to the eye, the footplate and the lower

20、 end of the plunger shall be washed with distilled water and wiped dry with gauze sponge immediately before use. If a suitable stand is not available, the mechanical tonometer footplate and lower end of the plunger shall be wiped with a gauze sponge moistened with 1- 5000 Benzalkonium Chloride Solut

21、ion (U.S.P.), rinsed with distilled water, and wiped dry with a gauze sponge immediately before and after each use. placed in suitable stand containing a 1-5000 Benzalkonium ! Cleaning. At the end of the days use, the plunger shall be removed from the cylinder of the mechanical tonometer after remov

22、ing the 5.5 gram weight. The plunger shall be wiped clean with a gauze sponge moistened with 70 to 95 percent alcohol. The plunger casing of the cylinder shall be thoroughly irrigated with warm distilled water to rapidly dissolve any crystals of salt which may have formed from tear fluid. The plunge

23、r casing shall then be irrigated with 70 to 95 percent alcohol, and the mechanical tonometer allowed to dry. The mechanical tonometer and the plunger shall then be kept in its closed carrying case until the next: days use. Certificate of inspection and calibration. Each instrument shall be accompani

24、ed with a certificate of inspection and test certifying that the instrument is dimensionally correct and has been calibrated. independent establishment as approved by the contracting agency. Workmanship. defects which detract from its appearance or impair its serviceability; corners . The certifying

25、 laboratory shall be an The mechanical tonometer shall be free from There shall be no sharp or rough metal edges or - Unit. Each (EA). One tonometer, as specified, constitutes one unit . 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54044 65

26、m 7777774 0013163 T m A-A-54 O4 4 Quality Assurance 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 cont

27、ract 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 the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such i

28、nspections are deemed necessary to assure supplies 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 f

29、rom 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. Inspection. Inspection, as used herein, is defined as both examination (such as visual om: auditory investigation without the use of special laborator

30、y appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Sampling 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

31、one tonometer. Sampling shall be level II and AQL of 1.0. Examination. Examination shall be conducted to determine compliance with specification requirements. Sampling for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. Unit of product for test pu

32、rposes shall be one tonometer. Sampling shall be level S-2 and AQL of 1.0. Tests. 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 Resale

33、No reproduction or networking permitted without license from IHS-,-,-. A-A-54 O 4 4 Contractor certification. The contractor shall certify that the pgoduct offered meets the salient characteristics o this description and conforms to the producers own drawings, specifications, standards, and quality

34、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 o the contract. 9 Regulatory requirements. Federal Food, Drug, and Cosmetic Act. If the product covered by this doc

35、ument has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall coniply and be responsible for compliance by its subcontractors/suppliers, with the,requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promu

36、lgated thereunder. 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 encour

37、aged to use the covered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical. Preservation, packaging, packing, labeling and marking. Unless otherwise specified, preservation, packaging, and packi

38、ng shall be to a degree of protectipn to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment ?rom the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rule

39、s and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. a NOTE: The following National Stock Number is covered by this document : NSN - ITEM IDENTIFICATION 6540-00-382-6100 TONOMETER, OPHTHALMIC, SCHIOTZ Ordering da

40、ta. Intermediate/exterior package quantities, labeling, and marking must be specified in the contract and/or order. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5LiOLi4 b5 W 9999974 OOL3Lb5 3 W A-A-54 04 4 MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD-MB ARMY - MD NAVY - MS AIR FORCE - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS GSA PGC: 45760 Project No. 6540-1215 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-