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Analgesic pump product quality standardization of technology (Trial)
First, the electronic analgesic pump 1. Reusable electronic analgesic pump (with a one-time storage of medicine bags and pipes) 1.1 Basic 1.1.1 for the purpose of analgesic reusable portable infusion pump, and its supporting The use of disposable storage bags and pipelines and other accessories.Electronic devices to control and drive liquid output, the use of disposable storage bags (bags) and pipelines in line with YY 0451-2003 "disposable infusion pump" standard Related Terms .1.1.2 With patient controlled drug delivery (PCA function), with basic set flow and patient controlled drug delivery (PCA) capacity control functions .1.1.3 with lock interval time setting function .1.1.4 Have to prevent the patient and other non-staff to change the settings of the safety protection device.1.1.5 with air bubbles, pipeline blockage, liquid waste, lack of battery and other abnormal sound and light alarm.1.1.6 flow rate is stable and accurate, the error rate Not more than ± 10% .1.1.7 with liquid filter, the filtration rate of not less than 80% .1.2 enhanced 1.2.1 for analgesic purposes reusable portable infusion pump, and its use of a Storage bags and pipelines and other accessories. With electronic devices to control and drive liquid output, the use of a Sexual storage bags (bags) and pipelines comply with the relevant provisions of YY 0451-2003 Standard for Single Use Infusion Pumps.1.2.2 Patient-controlled drug delivery (PCA function) with basic set-point flow and patient controlled (PCA) capacity control function .1.2.3 has a lock interval setting function .1.2.4 has to prevent patients and other non-staff to change the settings of the safety protection device .1.2.5 with air bubbles, pipeline blockage, medicine Fluid run out, battery shortage and other abnormal sound and light alarm function .1.2.6 with a pipe off alarm and automatic alarm shutdown function, effectively prevent accidental drops of liquid medicine input .1.2.7 with equipment failure alarm and automatic reporting of causes Or fault code display) and other functions .1.2.8 The flow rate is stable and accurate, the error rate is not greater than ± 5% .1.2.9 with liquid filter, filtration rate of not less than 90% .1.2.10 with human-machine interface query Note the time, infusion dose .1.2.11 can query PCA needs through the man-machine interface, the number of PCA administration, D / D ratio analysis, PCA time and frequency distribution analysis .1.2.12 with computer data Of the interface, can provide the appropriate computer applications, or provide data interface protocol. 1.2.13 has a more complete record of alarm records and alarm analysis of the reasons for review .1.2.14 has a keyboard lock function .1.2.15 with two or more time-limiting total flow setting function .2 disposable electronic analgesia pump 2.1 Basic 2.1.1 Electronic devices control the drive liquid output, for the purpose of analgesic single-use portable infusion pump, electronic control drive and drug bag pipe and other accessories are a one-time use. Medicine bags (bags) and pipelines and other accessories should be consistent with YY 0451-2003 "disposable infusion pump" standards related requirements .2.1.2 with patient-controlled drug delivery function (PCA function) .Basically set the flow and the patient Controlling volume of PCA 2. 2.1.3 Setting function with lock interval time.2.1.4 There are safety protection devices to prevent patients and other non-staff members from changing this setting.2.1.5 With air bubbles and pipeline plugging , Liquid chemical run out, battery shortage and other abnormal sound and light alarm .2.1.6 flow rate is stable and accurate, the error rate is not greater than ± 10% .2.1.7 with liquid filter, filtration rate of not less than 80% .2.2 Enhanced 2.2.1 by the electronic device-driven liquid medicine Output, disposable infusion pumps for analgesic purposes, electronic control drives, and drug bag tubing, etc. All disposable accessories such as disposable drug bags (bags) and tubing used should comply with YY 0451-2003 "Disposable Infusion Pump" standards.2.2.2 Patient controlled drug delivery (PCA function) .Control function with base set flow and patient controlled drug delivery (PCA) capacity.2.2. 3 has a lock interval time setting function.2.2.4 has to prevent patients and other non-staff to change the settings of the safety protection device.2.2.5 with air bubbles, pipeline blockage, run out of liquid, lack of battery and other abnormal sound Light alarm function .2.2.6 with equipment failure alarm and other functions .2.2.7 flow rate is stable and accurate, the error rate is not greater than ± 5% .2.2.8 with liquid filter, filtration rate of not less than 90% .2.2.9 with Can check the infusion time, the function of infusion dose .2.2.10 can query PCA requirements, the number of PCA administration .2.2.11 has a keyboard lock function .2.2.12 with two or more periods of the total flow limit setting function Second, the mechanical analgesic pump 3. Disposable mechanical analgesia pump (CBI + PCA) 3.1 The 3.1.1 product must meet the YY 0451-2003 "disposable infusion pump" standard 3.1.2 through the resilience of the reservoir to provide power, stable and accurate flow rate, the error rate is not greater than ± 15% .3.1.3 with Liquid filter, the filtration rate of not less than 80% .3.1.4 injection port without reflux, no leakage, to avoid drug-induced infections .3.1.5 protective shell is strong, the reservoir does not burst under the nominal capacity. 3.1.6 with patient-controlled infusion (PCA) function, each time the fluid volume is not less than 0.5ml, with a time-limiting function, the error is not greater than the nominal ± 20% .3.1.7 instantaneous flow rate shall not exceed the nominal flow rate 1.5 times .3.2 enhanced 3.2.1 products must comply with YY 0451-2003 "disposable infusion pump" standard 3.2.2 by the resilience of the reservoir to provide power, stable and accurate flow rate, the error rate is not greater than ± 10%. 3.2.3 with liquid filter, filtration rate of not less than 90% .3.2.4 instantaneous flow rate shall not be greater than 1.5 times the nominal flow rate .3.2.5 injection port without reflux, no leakage, to avoid drug-induced infection. 3.2.6 protective housing is strong, the storage bag does not burst under the nominal capacity .3.2.7 with patient-controlled infusion (PCA) function, each time to the liquid volume of not less than 0.5ml, with a limited time Every function, the error is not more than ± 20% of the nominal plant .4. Disposable mechanical analgesia pump (CBI) 4.1 Basic 4.1.1 The product must meet the YY 0451-2003 "Single use infusion pump" standard 4.1. 2 through the resilience of the reservoir to provide power, the flow rate is stable and accurate, the error rate is not greater than ± 15% .4.1.3 with liquid filter, filtration rate of not less than 80% .4.1.4 injection port without reflux, no Leakage, to avoid drug-induced infection.4.1.5 protective shell is strong, the storage bag does not burst at nominal capacity.4.1.6 instantaneous flow rate shall not be greater than 1.5 times the nominal flow.4.2 enhanced 4.2.1 products must meet YY 0451-2003 "Disposable infusion pump" standard 4.2.2 Through the resilience of the reservoir to provide power, the flow rate is stable and accurate, the error rate is not greater than ± 10% .4.2 with liquid filter, filtration rate Not less than 90% .4.2.4 instantaneous flow rate shall not be greater than 1.5 times the nominal flow rate .4.2.5 injection port without reflux, no leakage, to avoid drug-induced infection.4.2.6 protective housing is strong, Weigh capacity does not burst.