DOD A-A-53367A-1989 SONIC PROPHYLAXIS UNIT DENTAL PORTABLE AIR DRIVEN《音波预防气动便携式牙科治疗机》.pdf

1、9 -* A-A-53367A 65 m 7777774 0030385 3 m A-A-53367A A-A-5336 7 22 February 1988 COMMERCIAL ITEM DESCRIPTION SONIC PROPHYLAXIS UNIT, DENTAL, Portable, Air Driven The General Services Administration has authorized the use of this Commercial Item Description, prophylaxis unit suitable for use in removi

2、ng dental calculus. This Commercial Item Description covers an air driven, sonic Salient Characteristics: Shall be an air driven (non-electric), sonic prophylaxis unit suitable for use in removing dental calculus. The sonic prophylaxis unit shall consist of one handpiece, swivel assembly, three tip

3、assemblies, and accessories as specified herein. The tip assemblies shall consist of: One (1) “universal“ tip suitable for all surfaces for removal of both heavy and medium calculus. One (1) “perio“ tip suitable for lingual, supragingival scaling o mandibular incisors and deep ocal pockets. One (1)

4、“sickle“ tip suitable or use on sensitive patients and provide alternative access for difficult posterior areas. Each tip assembly shall be furnished with a pliable, clear or translucent cover for protection and storage. The cover shall be capable of being cold sterilized. Accessories shall ihclude:

5、 One air pressure gauge. One round tip wrench. One package containihg one, 2 ounce, aerosol lubricant and conditioner. One spare parts container containing one rotor, one clean-out wire, four O-rings one plastic clamp wrench, one metal wrench and one elastomeric seal. AMSC N/A FSC 6526 DISTRIBUTION

6、STATEMENT A. Approved for public release; distribution is unlimited. r THIS DOCUMENT CONTAINS 7 PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-AA-533b7A 65 W 499997Li 0030386 5 W . A-A-53367A Material. Table I. The component materials shall b

7、e as specified in Table I. Component materials. IHandpice components I I i I I I Sheath (front portion) IBlack anodized aluminum alloy I I I l Sheath (proximal end I poxtion) I I Rear seal I Front suspension I Water tube I Rotor I I I Swivel I ITip assemblies 1 Operative en I I I Holder I I Base I I

8、 Clean-out wire I (606l-T6) . Martensitic stainless steel, Type 416. Buna-No Buna-N elastomerc “n-Rings. Stainless steel. Martensitic Stainless steel, Type 410, I I I I I I I I I I I I Black anodized aluminum alloy I I (6061-T6) . I I I IMartensitic stainless steel, I IType 449C. I I I Anodized alum

9、inum alloy (6061-1 IT6). I IMartensitic stainless steel, I IType 416. I IAustenitic stainless steel. I Style, design, and dimensions. The unit shall be an air driven, sonic handpiece with removable and interchanaeable tip assemblies and a &ive1 assembly to provide a 3600 rhation o? the handpiece. Th

10、e tip assemblies (tip and tip holder) shall properly mrew into the handpiece. The swivel shall be held into the handpiece by means o a snap ring. design, and dimensions o the unit shall conform to Defense Personnel Support Center (DPSC) Drawing #23401. The style, When all components are assembled, t

11、he tip assembly (tip an tip holder) and the hollow shaft which extends the length of the handpiece shall form a rigid connection. The shaft shall be suitably suspended (front and rear). The unit shall operate from compressed air which shall drive (rotate) a thin walled rotor by passing through nozzl

12、es in the shaft wall - causing shaft vibration which is amplified by the tip. The motion of the rotor relative to the shaft shall be eccentric. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-e e e . - A-A-53367A 65 7777774 0030387 3-* A-A-53367A T

13、he unit shall be suitable for operation by 1.50, plus 0.07, minus 0.16, standard cubic feet per minute (SCFM) of air at a pressure of 40, plus O, minus 5 pounds per square inch gage (PSIG) and 25, plus or minus 5, cc/min of water at a minimum pressure of 15 PSIG. The tips shall be self-tuning and sh

14、all vibrate (resonate) at a frequency of 6100 plus or minus 300 Bz with the universal tip amplitude of 0.010 inch, plus 0.001 inch, minus 0.003 inch, peak to peak, orbital motion. Water shall be delivered to the tip by passing through a water tube in the shaft and then through a small integral tube

15、within the tip holder. The design and vibration characteristics of the tips shall allow water to flow by surface contact effect to within 1/4 inch of the free end of the tip before spraying occurs. The water channel of the tip assemblies (tips and tip holders) shall be “office cleanable“ with the us

16、e of clean-out wires to clear any blockage of the water channel. The tip assemblies shall be autoclavable, dry heat sterilizable, and quickly changeable. The tips shall have a diamond cross-section and shall incorporate a spherical tip to give clinical function with minimum tooth damage and maximum

17、patient comfort. The swivel assembly shall have a 4 hole back end suitable for attachment to a standard, 4-line handpiece tubing assembly, and shall meet IS0 standards for dimensional configuration. The pressure gage shall be suitable for connection between the handpiece and the hose (tubing) end to

18、 permit setting and adjustment of air pressure. The gage shall have a range of zero to sixty pounds per square inch (psig) with increments of at least 2 psig (scale shall also be marked with metric graduations). The pressure gage shall be required only for initial adjustments and shall not be requir

19、ed during use of the handpiece. The weight of the unit (handpiece with a tip connected) shali be 2 ounces plus or minus 1/4 ounce. Hardness. After proper stress relieving, the Rockwell hardness of the operative ends shall be C56 to C60, when tested in accordance with ASTM E18 or ASTM E92 and E140. P

20、assivation. All stainless steel shall be properly passivated. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-I Corrosion resistance. The ,ips shall show no signs of corrosion when tested in accordance with the copper suleate and boil test requirem

21、ents of ASTM F1089. tip holder), shall be capable of being autoclaved as specified herein without showing any signs of corrosion, reduction in performance, or malfunction. Autoclave test. The handpiece and tip assemblies (tip and Operational test. Each handpiece with a tip assembly attached shall be

22、 subjected to an operational “run-in” test as specified herein without: malfunction or reduction in performance. anomfinish. swivel shall have a satin or matte finish, of the tips shall have a smooth bright finish except for the sharpened edges which shall have a finely honed finish. The operative e

23、nds shall have sharp cutting edges and shal be free of defects such as coarge grind marks, cracks, gouges, bums, feathers, 01 other imperfections which affect performance. Finish. The front portion of the sheath shall have a black The operative ends The proximal end of the sheath and the Instruction

24、s. Instructions for installation, use, sterilization, maintenance and repairs, trouble shooting guide, and list of spare parts and accessories shall be provided with each unit. Identification. the name or registered trademark of the manufacturer. s o foreign manufacture, the unit shall be marked wit

25、h the country of origin. The prophylaxis unit shall be marked with If unit Color codin . The holder of each tip assembly shall be color _aa_g CO e a6 follows: Universal-black, perio-natural and sickel-blue. Workmanshi serviceability. constitutes one unit. The sonic prophylaxis unit shall be free fro

26、m defects -r-rl?a w IC etract from its appearance or impair its Unit. Each (EA). One sonic prophylaxis unit, as specified, 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53367A Quality Assurance Provisions. Responsibility for inspection. Unles

27、s 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 facilities suitable for the performanc

28、e 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 conform to prescribed requirements.

29、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 the contract and for a period of three years after deliv

30、ery 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 technical means of physical and chemical p

31、roperties) of the item. Sampling for inspection. Sampling for inspection shall be conducted in accordance with MIL-STD-105. Where feasible, the same sample shall be used for the determination of two or more inspection characteristics. The unit of product for inspection purposes shall be one prophyla

32、xis unit. Unless otherwise specified, sampling for examination shall be conducted at inspection level II, AQL 2.5, and sampling for tests (when applicable) shall be conducted at inspection level S-1, AQL 1.0. to determine compliance with specification requirements. specification requirements. Examin

33、ation. The unit (handpiece and tips) shall be examined Tests. Tests shall be conducted to determine compliance with 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53363A b5 Ol130390 7. A-A-53367A Autsclave test. The unit shall be wrapped in mu

34、slin and autoclaved at 270 degrees F plus or minus 5 degrees F and 27 plus or minus 1 pounds per square inch for a minimum o 20 minutes. The unit shall then be inspected and tested for compliance with specification requirements. innBl operating conditions. The unit shall then be inspected and tested

35、 or compliance with specification requirements. Operational run-in test. Each unit shall be operated, run- Contractor certification. product Offered meets the salient characteristics of this The contractor shall certify that the - description and conforms to the producers own drawings, speciications

36、, standards, and quality assurance practices. The Government reBerve6 the right to require proof o such conormance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. wi13 be considered on an equal basis with those manufactured ueing inchpoun

37、d units, providing they fall within the tolerances apecified using conversion tables contained in the latest revision of Federal Standard No. 376, and all other requirements o this document are met. If a product is manufactured to metric dimensions and those dimensions exceed the tolerance specifie

38、in the fnch/pound units, a request should be made to the contracting oficer to determine of the product is acceptable. contracting officer has the option of accepting or rejecting the product. Regulatory requirements. by this document has been determined by the U.S. Food and Drug Administration to b

39、e under its jurisdiction, the oferor/contraetor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, an tegulations promulgated thereunder. In addition, the offeror/contractor shall complyr and

40、be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and cegulations. Metric products. Products manufactured to metric dimensions The Federal Food, Drug and Cosmetic Act. If the product covered Re

41、covered materials, The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulati& Subpart 23,4 to the maximum extent practical. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted

42、 without license from IHS-,-,-_ A-A-53367A 65 m 7777774 0030371 7 m A-A-53367A Preservation, packaging, packing, labeling, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under n

43、ormal shipping conditions, handling, etc:, involving shipment from the supply source to 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 shall be as speci

44、fied in the contract and/or order . NOTE: The following National Stock Number is covered by this document : National Stock Number Item Identification 6520-01-162-2906 SONIC PROPHYLAXIS UNIT, DENTAL, Portable, Air Driven Ordering data. Intermediate/exterior package quantities and labeling and marking

45、 must be as specified in the contract and/or order. MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: Army - MD Navy - MS Air Force - 03 Agent: DLA-DM VA-OSS PHS FDA-MPQAS DoD-MB CIVIL AGENCY COORDINATING ACTIVITIES: 51793 Project No. 6520-2217 Location8 NCR Disk #4 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-