1、A-A-53B37 65 W 7797779 0032342 7 W A-A- 53 83 7 30 May 1989 COMMERCIAL ITEM DESCRIPTION ELECTROSURGICAL APPARATUS The General Services Administration has authorized the use of this commercial item description. This commercial item description covers a lightweight, portable, AC, solid state electrosu
2、rgical apparatus. Salient characteristics: The electrosurgical apparatus shall be compact, solid state, lightweight and shall not exceed 45 pounds. The unit shall be portable, suitable for performing urological, and general surgical procedures. The outside dimensions of the unit shall not exceed 18
3、inches by 14 inches by 7 inches. The unit shall be equipped with an appropriately rated three-conductor line cord terminated in accordance with Underwriters Laboratories, Inc. (UL). The unit shall be equipped with approved hospital-grade 3-prong plug. The unit shall be suitable for operation on nomi
4、nal 115 volt, 50/60 Hz. electric power (230 volt, 50/60 Hz. when so specified in the procurement document). The output power for the unit shall not exceed 1500 VA for full operation. The unit shall have a minimum of the following connections for accessories: a. A connector or jack for the patient re
5、turn electrode. b. Connectors or jacks for simultaneous attachment of one standard type active electrode, one forceps type coagulating electrode with built-in control switch for selection of cut or coagulation modes. - a msc N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distrib
6、ution is unlimited. THIS DOCUMENT _- CONTAINS PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53837 65 W 9999974 0032343 O A-A-53 8 3 7 c. A connector or jack for attaching an explosion-proof or intrinsically safe foot switch to enable sel
7、ection of the cut or coagulation modes. d. A common return. The unit shall be supplied with the fol.lowing accessories: a. b. d. e. f. 4- h. i. C. A 1/16 inch ball electrode. A flat cutting electrode. A straight 1/2 inch blade Two reusable active electrode chuck handles with ten foot cords. A 45 deg
8、ree angle 1/2 inch cutting electrode. A straight needle point electrode. An explosion-proof or intrinsically safe (low voltage current limited) foot switch. A dummy load. Two patient plates with cords. The unit shall have a minimum of the following modes of operation with controls: a. b. C. output r
9、emain Cut mode: Cutting mode power shall be in range, which allows precise spee and depth of cutting effect. Coaguation mode: Coagulation motor power shall be in range, which allows exact hemostatic effect with minimum tissue destruction and charring. Modified cut mode: The modified cut mode shall c
10、ause the application of intermittent radio frequency (IRF) power to the active electrode to allow control of the degree of hemostasis. * 1 power, as measured at the active electrode, shall constant within 10 percent, with typical 105-130 volt line voltage fluctuations. The unit shall have isolated o
11、utput circuits., i.e., output not referenced to ground. b 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53837 65 9777774 0032344 2 m . Unit shall meet NFPA 493, UL 540, and AAMI HF-18 Electrical Safety Standards. Al1 items shall conform to th
12、e applicable requirements of nationally recognized standards for the safety of rfiedcal equipment of the issue in effect on the date of solicitation. All items shall be approved as conforming to such a standard by an independent, nationally recognized testing laboratory. A-A-53837 The unit shall gen
13、erate niinimal radio frequency interference (RFI)? both radiated and conducted, through the power line. The active cable of the ECU shall be properly shielded to limit radiai-ed losses and prevent capacitive coupling into nearby wires and metal equipment. The unit shall be provided with a positive o
14、n/off switch. An indicator light shall signal that the ESU has been turned on. Separate visual indicators shall be incorporated to indicate when the ESU output has been activated. In addition, separate distinct audible tones shall indicate cut and coag output activation. An adjustable volume control
15、 which cannot reduce the sound level below 45 dB shall be provided. Overcurrent prokection for the ESU, preferably in the form of a circuit breaker, is required. If a fuse is used? a spare must be provided and clearly labeled as to function and rating. impinging against it. Circuit breakers niust be
16、 protected from other objects Mininium length of the cords and cables supplied shall be: Cable Type Line Cord Act j.ve Dispers ive Foot; s w i t-, c h - Leng t 11 3.0 meters (9.8 feet) 2.5 meters (8.2 feet) 2.4 meters (7.9 feet) 3.0 meters (9.8 feet) -.- Workmanship. defects which detract from its a
17、ppearance OK impair its serviceability. The electrosurgical apparatus shall be free from 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 3 8 3 7 Unit. Each (ea). One electrosurgical apparatus along with accessories, as specified, constitutes
18、one unit. Quality Assurance Provisions. Responsibility for inspection. Unless otherwise specified the contract or Durchase order, the contractor is responsible in for the performance Qf all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order,
19、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 inspections are deemed ne
20、eessary 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 rnade available to the Government upon the Governments request, at any time, or from time to time, durin
21、g 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 or auditory investigation without the use of special laboratory appliances or procedur
22、es) and testing (determination by technical means of physical and chemical properties) of the item. specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics. Tests. Tests shall be conducted to determine compliance with First
23、article Inspection. First article inspection shall be performed on the electrosurgical unit when a first article sample is required. This inspection shall include examination and tests. Quality conformance inspection. Quality conformance inspection shall include the examination and tests specified h
24、erein. 4 P Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-_- A-A-53437 b5 777797LI 00321116 b U A-A-5 3 8 3 7 Certificates of quality. Certificates of quality, supplied by the manufacturer of the materials, may be furnished in lieu of actual perform
25、ance of such testing by the contractor, provided lot identity has been maintained and can be demonstrated to the Government. The certificate shall include the name of the contractor, the contract number, the name of the manufacturer or: supplier, the item identification, the name of the component/ma
26、terial, the lot number and the lot size. conducted in accordance with MIL-STD-105 with an AQL of one (percent defective) and an inspection level of -2. The unit of product for sampling purposes shall be one electrosurgical apparatus. Samplinq for examination. Sampling for examination shall be DEFECT
27、S Unit not complete with all components, equipment items, and accessories. Any component, equipment item or accessory broken. Any switch and/or control position not identifiable when viewed at a front distance of 2.5 meters (8 feet) by a viewer with corrected 20/20 vision. Any cooling fan exhausts a
28、ir over a sterile field. Footswitch does no% have suitable mechanical protection against accidental depression. Manual, as specified, not included. Unit not clean. Any rivet not properly installed, screw not tight. test, shall be conducted in accordance with MIL-STD-105, with an AQL of one (percent
29、defective) and an inspection level of S-2. The unit of product for sampling purposes shall be one electro- surgical apparatus. this specification. Samplinq for tests. Sampling for tests, including dimensional Tests. Tests shall be conducted to determine compliance with Provided by IHSNot for ResaleN
30、o reproduction or networking permitted without license from IHS-,-,- A-A-53837 65 777777 003Z1117 8 A-A- 53 8 3 7 a. First article. Where a first sample is required, all tests shall be performed on that unit. b. Acceptance testinq. When a first article sample has not been required, one unit shall be
31、 subjected to the performance test specified herein. If a first article samyle has successfully passed all tests, performance test shall not be required at acceptance. Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch/
32、pound units, providing they fall within the tolerances 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 specifi
33、ed 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. Contractor certification. The contractor shall certify that the product offered meets the salient c
34、haracteristics of this description and 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 provisio
35、ns o% the contract. Requlatory requirements. Federal Food, Druq and Cosinetic Act. If the product covered by this document has been determined by the U.S. Food and Druq Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontr
36、actors/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 F
37、ederal, State, and local statutes, ordinances, and regulations. - f 4 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-a- 7 A-A-53837 b5 7999774 00321i1 T i“ A-A-5 3 8 3 7 Recovered materials. The offeror/contractor is encouraged to use recovered ma
38、terial 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, packaginq, packing, labelinq and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of
39、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, ?lus reshipment from receiving activity and shall conform to applicable carriers rules and regulations. Intermedi
40、ate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. NOTE: The following National Stock Number is covered by this cl oc um en t : 6-31 5-0 0-13 7 -6 51 1 Ordering data. Intermediate/exterior package quantities and labeling and marking must
41、be specified in the contract and/or order a O MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD - MB Ariny - MD Navy - MS Air Force - O3 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4189 Location: CID/ESA/HlG-30 7 *V.S. GOVERNMENT PRINllNC OFFICE: W - 6MQu1Ut78 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
