DOD A-A-54015-1989 ELECTROCARDIOGRAPH AUTOMATIC SOLID STATE PORTABLE《便携式固态自动心电图仪》.pdf

1、g - 5 - 35 A-A-5 4 O 15 25 October 1989 COMMERCIAL ITEM DESCRIPTION ELECTROCARDIOGRAPH Automatic, Solid State, Portable This General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers an all solid state, electrocardiograph with

2、 a minimum of three sensitivities. single channel, dual speed, direct writing, portable Salient characteristics: The device shall be all solid state, single channel, dual speed, direct writing, portable, with a minimum of three sensitivities. It shall have twelve lead recording capability for I, II,

3、 III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6 leads. The strip chart recorder shall have two selectable speeds of 25 and 50 mm/sec, plus or minus 2 percent. The electrocardiograph shall have sensitivities of 5, 10, and 20 mm/mv, plus or minus 2 percent. The recorder shall have a thermal stylus or d

4、ot matrix printhead. If a stylus, it shall be easily replaceable,. producing sharp, clear, and uniform traces. There shall be adjustments for stylus heat, position, and pressure. Hysteresis-return to baseline and baseline drift shall be minimal. For heated stylus recorders, the recording chart paper

5、 shall be 63 mm wide, overall 150 feet long, with a 50 mm grid width ruled in 1 mm by 5 mm squares. (dot matrix) recorders, the recording chart paper shall be 59 mm wide, overall 150 feet long, with a 45 mm grid width ruled in 1 mm by 5 mm squares. Manual and automatic recording modes shall be selec

6、table for each lead. For thermal array Automatic lead marking shall function for both automatic and manual modes. AMSC/NA FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. F . THIS DOCUMENT CONTAINS 7 PAGES. Provided by IHSNot for ResaleNo reproduction or net

7、working permitted without license from IHS-,-,-A-A-5 4 O 15 Calibration pulse shall function for both automatic and manual modes , The electrocardiograph shall be protected for standard Lown or equivalent differential pulse to 400 watt seconds terminated to patient. Isolation circuitry shall limit t

8、otal leakage current between patient leads (ECG) and ground to the value specified in ANSI/AAMI ES 1 - 1985, American National Standard, Safe Current Limitg fox Electromedical Apparatus. Electrical characteristics, The equipment item furnished by the contractor must be capable of operating on both 5

9、0 and 60 Hertz (Hz) power souxes. Voltage characteristics or this item shall peimit the item to be operated on both o the Lollowing single phase voltage sources: 110 volt, 60 Hz; and 110 volt, Li0 Hz. Items offered which normally operate on a nominal voltage range of 220 volt to 380 volt (single pha

10、se) rathei: than 110 volt will be accepted only if the item is capable of functioning on both 50 and 60 Hz, In order to meet this requirement, contractors may include a 60 Hz conversion kit with adequate instructions or the Government to perform the modification. The kit will be separately identifie

11、d and priced on the bid/pcoposal and include a statement as to the number o manhours required to perorm the modification. Complex modifications requiring more than one manhour to accompXish will not be accepted, a 60 Hz rated pioduct is offered which does not require modification to allow opration a

12、t other than its rated requency, the contractor will so certify in his bid/pioposal, as well as identify any special operating conditions/limitations/requirements and liability and considecations which might ensue because of operation on other than the items normal rated frequency, Accessories, stan

13、dard accessories: In instances in which a 50 or Each unit shall be supplied with the following 0 One patient cable shall be supplied, 0 One each adult Welsh 0 One power cord shall 0 Foui each aduJ-t: limb 0 Four each adult limb supplied suction chest electrode shall be be supplied, electrodes shall

14、be supplied. straps shall be supplied. 2 O 2- O 9 Y Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54015 65 W 7777774 0032772 4 A-A-5 4 O 15 0 One each tube/bottle electrode crearn/gel shall be 0 Two each rolls ECG chart paper shall be supplied.

15、 supplied. 0 Chart paper mounts shall be supplied. A dust cover shall be supplied. The electrocardiograph shall conform to the standards of electrical leakage currents or operator safety as specified in UL544 - “Standard for Safety of Electrical Medical and Dental Equipment“, and NFPA 99-1987, Chapt

16、er 9, “Manufacturer Requirements.“ TWQ complete instruction, operation, maintenance, and repair manuals shall be furnished. The patient cable leads supplied with the electrocardiograph shall be color coded in conformance with AHA publication, “Recommendation for Standardization of Leads and of Speci

17、fication for Instruments in Electrocardiography and Vectorcardiography“. The patient cable connector shall be a 3 lead/ pin type configured in accordance with AAMI ECGC-5/83 “Standard for ECG Connectors“. The electrocardiograph performance standards shall be in accordance with ANSI/AAMI ECll-1982 “A

18、merican National Standard for Diagnostic Electrocardiograph Devices“. The electrocardiograph shall measure no more than 20 inches long by 15 inches wide by 6 inches high. The unit shall weigh no more than 10 pounds. Workmanship. The electrocardiograph shall be free from defects Unit, Each (EA). One

19、electrocardiograph, as specified, which detract from its appearance or impair its serviceability. constitutes one unit. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5403.5 PUALITY ASSURANCE PROVISIONS Responsibility Por inspection. Unless othe

20、rwise specified in the contxact or purchase order, the contractor is responsible for the performance of all inspection requirements (examinations and tests) as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable

21、 for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any o the inspections set forth in the specification where such inspections are deemed necessary to ensure supplies and services conform to prescri

22、bed requirements. c Records. Records of examinations and tests performed by-or for the contractot: 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 or a period of thz

23、ee 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 um OE special laboratory appliances 01: procedures) and testing (determination by technical means of phys

24、ical and chemical properties) of the item, Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasibler the same sample shall be used for the determination of two or more test chazacteristics. Sampling or examination. Sampling for examination shall be cond

25、ucted in accordance with MIL-STD-105, with an AQL of 1.0 (percent deective) and an inspection level o II, The unit of product: for examination purposes shall be one electrocardiogxaph, as specified in this description. 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without li

26、cense from IHS-,-,-A-A-5 40 15 Sampling for tests. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 1.5 (percent defective) and an inspection level of S-l. The unit of product for test purposes shall be one electrocardiograph. Tests. Pe

27、rformance test. The electrocardiograph shall be completely assembled in its operating configuration and tested to determine compliance with this specification. Testing shall include Acceptance Testing. Input dynamic range test. The ECG device shall be capable of responding to and displaying differen

28、tial voltages of plus or minus 5 millivolts (mV) varying at a rate up to 320 mV per second from a dc offset voltage in the range of -300 mV to +300 mV, when applied to any lead. The time- varying output signal amplitude shall not change by more than plus or minus 5 percent over the specified range o

29、f dc offset. Time base accuracy test. Record for at least 4 seconds at each time base, disregarding or discarding the first 1 second of data in each strip. Using calipers and a vernier scale calibrated to 0.1 mmf measure the distance between lo, 20, and 40 successive peaks; the distances must be wit

30、hin 10 plus or minus 0.2 mm, 20 plus or minus 0.4 mm, and 40 plus or minus 0.8 mm, respectively. Repeat the measurements at least three times at different parts of the strip for each time base. Verify that the measurements fall within the plus or minus 2 percent error band each time. Metric products

31、: Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision f Federal Standard 376, and all other requirements of this do

32、cument 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 made to the contracting officer to determine if the product is acceptable. The contracting officer has the option of accepting or reject

33、ing the product. 5 A-A-SqOL5 65 9 7777774 003277LI B I - Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Contractor certification. product ofeered meets the salient characteristics of this description and conforms to the producers own drawings, speci

34、fications, standards, and quality assucance practices. Government xeserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. The contractor shall certify that the The Regulatory requirements, F

35、ederal 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 sfferor/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the

36、 Federal Food, Dxug and Cosmetic Act, as amended, and mgulations promulgated thereunder. In addition, the ofeersr/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,

37、and regulations. md materials. The offeror/contxactor is encouraged to use recovered 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, packaqinq, packing, labelins, and marking.

38、Unless otherwise specified, preservation, packaging, and packing shall be to a degree o protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply eource to the receiving activity, plus reshipment from rece

39、iving 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 NOTE: The following National Stock Number is covered by this document . 6515-01-169-6006 Ordering d

40、ata. 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-54015 b5 m 9999974 0032796 1 I! A-A-54015 Custodians: Army - MD Navy - MC Air F

41、orce - 03 Preparing activity: DOD - MB Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS Project No. 6515-4333 Location: CID/ ELECTROCARDIOGRAPH/Hl7-35 *U.S. GOVERNMENT PRINTING OFFICE: 1989-704-034/30006 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-