DOD A-A-55709-1996 PUMP INTRAVENOUS INFUSION《静脉输入泵》.pdf

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1、 A-A-55709 9999974 0372826 612 W I INCH-POUND 1 A-A- 557 O9 16 August 1996 - COMMERCIAL ITEM DESCRIPTION PUMP, INTRAVENOUS INFUSION The General Services Administration has authorized the use of this Commercial Item Description for all Federal Agencies. 1. SCOPE. This Commercial Item Description cove

2、rs a portabie, battery operated, rechargeable, volumetric intravenous infusion 2. SALIENT CHARACTERISTICS: 2.1. Shall be a portable, rechargeable, battery operated, volumetric. intravenous infusionpump, suitable for the safe administration of fluid therapy. 2.2 in operation. Shall be possible to rec

3、harge the battery while the pump is 2.3 volumetric method. Shall accurately measure the fluid administration by the 2.4 Shall be capable of preselecting a volume to be administered from 1 to 999 mls. The rate of flow should at least range from 1 ml per hour to 200 hours, in 1 ml increments. Benefici

4、al comments (recommendations, additions, deletions) and any pertinent data which may be of use in improving this document should be addressed to: Headquarters, Defense Personnel Support Center, Directorate of Medical Materiel, DPSC-MBP, 2800 South 20th Street, Philadelphia, PA 19145-0530, by using t

5、he self- addressed StandardizatLon Document Improvement Proposal, 1426) appearing at the end of this document or by letter. (DD Form AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Provided by IHSNot for ResaleNo reproduction or networking permitte

6、d without license from IHS-,-,-A-A-55 7 09 9979974 0372827 559 . A-A-557 O9 2.5 Shall have the following alarms and alerting mechanisms: a. Audible and visible air-in-line alarm. b. Visible low battery alarm that will operate one hour prior to need for recharging battery. c. An occlusion alarm to in

7、dicate occluded tubing or clogged filter. d. An audible alarm to indicate completion of infusion. 2.6 standard intravenous solution pole. Shall be capable of attachment to the upright portion of a 2.7 solution s.ets or as secondary sets with compatible tubing. 2.8 assembly and associated tubing, the

8、 pump should be capable of being cleaned monly accepted methods. Standard administration sets may be used between the With the exception of the disposable cassette and plunger 2.9 lessen the effects of intentional removal and/or accidental removal of the set/cassette to protect against uncontrolled

9、gravity infusions. Shall be provided with features designed to prevent and/or 2.10 Varying fluid container height, the maximum distance. allowed by the set tubing above and below the pump, shall not cause the flow error to be greater than () 5 percent. 2.11 the following single phase, nominal voltag

10、e sources as specified by the end user: . Voltage characteristics shall permit operation on any of 115 VAC k 10 percent, 50 Hz f 2 Hz 115 VAC k 10 percent, 60 Hz f 2 Hz 230 VAC k 10 percent, 50 Hz f 2 Hz 230 VAC f 10 percent, 60 Hz It 2 Hz 2.11.1 Equipment which operates on multiple frequency, 50/60

11、 Hz is acceptable. Shall have a power on/off switch and there shall be a clear, visual indication of line power connection and operation. 2.12 The pump shall be provided with a rechargeable, integral battery that shall provide, as a minimum, 4 hours of normal operation at a flow rate of 125 ml/hr. 2

12、 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-557 O9 2.13 activated at least 30 minutes prior to degradation of pump performance. audible alarm signaling interruption of infusion. battery signal shall precede the battery discharged alarm. A vi

13、sual and/or audible low-battery signal shall be A depleted battery shall be accompanied by an .The low- 2.14 With the unit connected to line power and operating at 125 ml/hr, it shall go from full discharge to 100 percent charge within 24 hours. With the power switch “OFF“ and the unit connected to

14、. line power, it should go from full discharge to 100 percent charge within 14 hours. There shall be a clear, visual indication of line power connection to signify battery charge when the pump switch is off. The battery shall have continuous recharge capability. 2.15 Equipment leakage current for eq

15、uipment powered by a nominal 110 VAC source shall not exceed the more stringent of the limits established in the ANSI-AAMI ES1 Standard for Safe Current Limits for Electromechanical Apparatus, or NFPA 99, Safety Standard for Healthcare Facilities, when measured as prescribed therein. For equipment p

16、owered by a nominal 220 VAC Source, leakage current shall not exceed those limits established in IEC- 601-1, Safety of Medical Equipment. 2.16 The equipment offered, should in so far as practical, be in accordance with applicable Guidelines and Preferred Practice for the Design of Medical Equipment.

17、 Nothing in this.standard shall be considered as limiting the selection of hardware, materials, or processes to the specific items described therein. Unless otherwise stated in specific provisions, this standards is applicable to the design of equipment for both men and women. 2.17 The pump shall be

18、 easy to Set-up, operate and correct alarms. The unit shall provide digital displays exhibiting amount infused, rate to be infused, and cumulative infusion volume for both primary and secondary infusions. 2.18 Units shall have a tamper proof feature to prevent patient from changing the flow rate or

19、turning off the unit. This may be accomplished by providing a locking device, programmable lock-out mode or other means of preventing unauthorized tampering. 2.19 If the devices front panel provides push button, keypad or membrane type touch sensors for data entry, adequate separation shall be provi

20、ded for activation by a single finger. Activation of the data entry device should provide an audible/tactile feedback. Invalid key depression may be indicated by an audible tone. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-55709 9999974 037

21、2829 321 A-A-55709 2.20 Labels or markings shall be durable, and shall clearly and concisely identify the function of all controls and indicators. Simple operating sequence instructions and important precautions shall be printed on or permanently displayed on the equipment. 2-21 Shall be designed to

22、 pass Aeromedical Certification requirements and must be in compliance with the following standards. Military standards shall be interpreted as though all units will be used aboard Military aircraft. 2.21.1 Electromagnetic Interference (EMI). The purpose of the EM1 tests is to verify Compliance with

23、 MIL-STD-461D and MIL-STD- 462D, “Electromagnetic Emission and Susceptibility Requirements for the Control of Electromagnetic Interference“, and Measurement of ENI Characteristics,“ respectively. 2.21.1.1 Radiated Emissions (RE-102) - This test measures radiated emissions generated by the unit. coul

24、d interfere with aircraft navigation and communication equipment. power source that it is configured for, such as internal rechargeable battery, 110VAC/60Hz, 110VAC/400Hzr and 28VDC. Excessive emissions The unit is tested while operating on each possible 2.21.1.2 Radiated Susceptibility (RS-103) - T

25、his test determines whether the ambient electromagnetic fields encountered in flight interfere with the operation of the unit. During exposure to the electromagnetic induction fields the unit is operated on each possible power source that it is configured for, such as internal rechargeable battery,

26、11OVAC/6OHz, 110VAC/400Hzr and 28VDC. 2.21.1.3 Conducted Emissions (CE-102) - This test measures emissions generated by the unit and conducted back up the power line. Excessive conductedemissions could affect the aircraft power supply and/or other systems powered from it. The unit is tested while op

27、erating on each possible power source that it is configured for, such as 110VAC/60Hz, 110VAC/400Hz, and 28VDC, except for internal battery. 2.21.1.4 Conducted Susceptibility (CS-101) - This test verifies that the unit will safely operate during allowable fluctuations in the aircrafts power supply. D

28、uring the exposure the unit is tested while operating on each possible power source that it is configured for, such as 110 VAC/60 Hz, 110 VAC/400 Hz, and 28 VDC, except for internal battery. 2.21.1.5 Conducted Susceptibility (CS-114) - This test verifies that the unit will safely operate during curr

29、ent fluctuations along its cables. During the exposure, the unit is tested while operating on each possible power source that it is configured 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- A-A-55709 = 9999974 0272830 043 A-A- 5 5 7 O 9 for, such

30、 as 110 VAC/6OHz, 110 VAC/40OHz, and 28 VDC, except for internal rechargeable battery. 2.21.1.6 Conducted Susceptibility (CS-115) - This test verifies that the unit will safely operate during transients in the aircrafts power supply. During the exposure, the unit is tested while operating on each po

31、ssible power source that it is configured for, such as 110 VAC/GOHz, 110 VAC/40OHz, and 28 VDC, except for internal rechargeable battery. 2.21.2 Vibration. MIL-STD-810Er Environmental Test Methods and Engineering Guidelines, are followed to test the units costructin, durability, performance, and the

32、 integrity of the - mounting device while withstanding random vibration and - sinusoidal vibration on the X, Y, and Z axes. 2.21.3 Environmental. MIL-STD-810E, the numerical values listed below do not come from any MIL-STD or other source document. They are modified versions of those in MIL-STDs, an

33、d simulated operational conditions. Environmental testing is performed under the following test conditions: 2.21.3.1 Humidity Operation: 94 it4 percent relative humidity, 85OF f3.6OF (29.5OC k2OC) for four hours. 2.21.3.2 Hot Temperature Operation: 120F it3.60F (49OC f2OC) for two hours. 2.21.3.3 Co

34、ld Temperature Operation: 32OF I7.2OF (OOC I4OC) for two hours. 2.21.3.4 Hot Temperature Storage: 140F it3.60F (-60C k2OC) for six hours. 2.21.3.5 Cold Temperature Storage: -40F f3.6OF (-40C k2OC) for six hours. 2.21.4 Altitude. MIL-STD-810Et each unit is subjected to reduced atmosphere pressures fr

35、om 522.7 mmHg, 10,000 ft equivalent in a hypobaric chamber. The exposure time varies with the equipment item under evaluation, but is usually a minimum of 1 hour. 2.21.5 Rapid Decompression. Decompressions in flight are uncommon; however, if one were to occur, the unit should not present a hazard to

36、 the patient, crew or aircraft operations. Each unit is subjected to a series of rapid decompression (RD) tests, starting at an equivalent pressure altitude of 8,000 ft 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-55709 9999974 OL7283L TBT .

37、 A-A-557 O9 with subsequent changes of altitude to 40,000 ft over periods of 60, 7, and 1 second. 2.21.6 Airborne Feasibility. Primary objectives of this phase are to identify problems with the unit that could not be evaluated in the lab, assess human factors in the aircraft environment (in accordan

38、ce with MIL-STD-l472D), assess ease of loading the unit on the aircraft, ensure visibility of visual alarms and audibility of audible alarms, check aircraft interface and unit securing methods, and the effect of the combined stresses of flight on the unit. 2.21.7 Military Standards in salient, chara

39、cteristic 2.21, shall be performed at: Armstrong Laboratory/CFTS Aeromedical Research Function 2504 D. Drive, Suite .1 Brooks AFB, Texas 78235-5104 2.22 Aeromedical Certification. The pump shall be designed to pass Aeromedical Certification requirements and must be in Compliance with,the following s

40、tandards. Military standards shall be interpreted as though all units will be used aboard military aircraft. 2.22.1 Electrical Safety Evaluations. The unit will not exceed the leakage current and ground resistance limits in AFI 41-203, Electrical Shock Hazards, which references National Fire Protect

41、ion Agency (NFPA) 99. 2.22.2. Environmental Testing to MIL-STD-810E. TEST METHOD TEST CRITERIA 501.3 High Temperature Operation 49OC/15 percent RH/2 hrs Procedure II Th medical device will operate correctly at temperatures up to and including 49OC. 501.3 High Temperature Storage 7loC/15 percent RH/

42、hrs Procedure I The medical device will operate after being stored in a high temperature environment (71OC) . 502.1 Low, Temperature Operation -2 5% /na/ 2 hrs 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 557 O 9 502.1 Low Temperature Stora

43、ge -46OC/na/6 hrs low temperature environment (-46OC). 507.3 Humidity 29.5OC/95 percent RH/4 hrs Procedure I The medical device will operate correctly in a high humidity and high temperature environment. 500.3 Altitude 15,000 ft. for 1 hr. The medical device will operate correctly in 9 low pressure

44、environment (15,000 foot altitude equivalent). 514.4 Vibration 2.116 Grams each Axis for 1 Hr Procedure The medical device will operate correctly in a vibration environment. Currently tested in each of three different axes in accordance with the procedure noted. 2.22.3 E1,ectromagnetic Characteristi

45、cs Testing to MIL-STD-461C limits: Method Frequency and/or V/m CE03 30Hz - 50kHz CE03 1OkHZ - 50kHz CE04 5OkHz - 5OMHZ The medical device shall not produce conducted emissions in excess of current MIL-STD-461C limits. 5okHz - 400MHz Spikes of 200 V/m cs02 CS06 The medical device shall not be suscept

46、ible to MIL-STD-461C test generated power spikes or signals induced on its power lines. 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-55709 rn 9999974 0372833 A52 rn A-A- 5 5 7 O 9 RE02 14kHz - 12.4GHz The medical device shall not produce rad

47、iated emissions in excess of current MIL-STD-461C limits. RS03 1OkHZ - LOGHz (2 OV/m) The medical device shall not be susceptible to radiated test fields produced to MIL-STD-461C levels. 2.22.4 Electromagnetic characteristics testing is conducted in accordance with current MIL-STD-462 methods to cur

48、rent MIL-STD-461C limits. Testing includes applicable conducted emissions and susceptibility as well as radiated emissions and susceptibility testing. 2.22.5 In-Flight Testing. A flight evaluation can only be performed .after laboratory evaluations are completed and an airworthiness release is obtai

49、ned.from ATCOM. 2.22.6 The medical device shall operate according to the performance test criteria in the aircraft without limitations due to environmental factors, including noise. The operator will be able to operate the medical device through it?s full range of functions while wearing the flight ensemble, including gloves and a flight helmet. The medical device shall not interfere with any aircraft syste