Workshop for APMP of TCFF Infusion pump analyzer calibration at NIMT Changping, Beijing, China (Thailand) 31 st October, 2015
Background The standard procedures for testing of infusion pumps (2012 2013) 2
Background The standard procedures for testing of infusion pumps (2012 2013) ISBN : 978-616-11-2153-2 3
Background The standard procedures for testing of infusion pumps (2012 2013) Objectives - For first acceptance - Periodic check: 3, 6 or 12 months - After maintenance Testing criteria Flowrates: ±5%, ±10% Occlusion: max. 1000 mmhg Air-in-line: max. 100 µl 4
Introduction 2015 2016 Infusion pump analyzer calibration (Thailand), NIMT Ministry of Science and Technology, MOST Department of Medical Sciences, DMSC Ministry of Public Health, MOPH Department of Health Service Support, HSS Ministry of Public Health, MOPH 5
Introduction 2015 2016 Infusion pump analyzer calibration Flow Range (10 1000) ml/h Flow Accuracy ±1% Expected uncertainty ±0.25% 6
Objectives of the project Introduction IEC 60601-2-24 ECRI The standard procedures for testing of the infusion pumps Calibration (Analyzer) Accuracy >> Uncertainty Flowrates: ±1% >>> 0.25% Occlusion: ± 1% >>> 0.30% Testing Flowrates: ±5%, ±10% Occlusion: max. 1000 mmhg Air-in-line: max. 100 µl 7
Introduction The calibration of the small flowrate [IEC 60601-2-24] Liquid level Liquid container (vented or collapsible bag) h Drip chamber Needle (18G, 1.2 mm, see ISO 7864) EUT Administration set 0.0000 g Electronic Balance Computer Figure 104a Test apparatus for volumetric infusion pumps and volumetric infusion controller [50.102, 60601-2-24] 8
The infusion pump analyzer calibration at NIMT Gravimetric method [IEC 60601-2-24] Flowrates; 10, 100 and 300 ml/h Accuracy of flowrates: ±1% Uncertainty of flowrates: ±0.25% Based on existing equipments in flow lab (NIMT) 9
The main components Liquid level 1. Flow generator Liquid container (vented or collapsible bag) h Drip chamber Needle (18G, 1.2 mm, see ISO 7864) EUT Administration set 0.000 g Electronic Balance Computer 3. Data acquisition system 2. Weighing balance 10
The main components 1. Flow generator 1.1 Infusion pump : Terumo TE-171 1.2 Controlled level tank : capacity 750 ml, height 1.75 m (from test bench) 2. Weighing balance Mettler Toledo : MS1003S, max load 1020 g, resolution 1 mg 3. Data acquisition system LabView: RS232 4. Other equipments PT100, Digital thermo-hygrometer, SS tube ¼ 11
1. Flow generator The main components 1.1 Infusion pump : Terumo TE-171 Flow controller by using pump Pulsating flow 1.2 Controlled level tank : capacity 750 ml, height 1.75 m (from test bench) SS tubing ¼ Metering valve for adjusting the flowrates Steady flow Low head pressure 12
2. Weighing balance The main components Mettler Toledo : MS1003S, max load 1020 g, resolution 1 mg Balance level Load symmetry Evaporation Protection shield 18G needle, jet impact 13
3. Data acquisition system The main components LabView: RS232 Collecting data from the balance Collecting time can be varied (1, 5 or 30 sec) 14
4. Environmental conditions The main components Temperature (20 ± 2) C Humidity (50 ± 15) %RH 15
Flow determination ISO/TR 20461 : mass to volume Q m w x Z t xy m w the balance reading of delivered water Z the combined factor for buoyancy correction and conversion from mass to volume Y the thermal expansion correction factor of the delivering device t the period of time 16
Flow determination Mass of measured water (collecting system consideration) 18G needle Absorber reduce jet impact Cover Evaporation protection Fluid level Shield Variation of the environment Balance pan 17
Experimental procedures - 1 Infusion pump Supply tank Set Flowrates (ml/h) 10, 100, 300 Infusion pump analyzer IDA5 Weight Balance (period of time 30 s) Result of Experiment 1 [flow generators comparison and analyzer calibration] 18
Experimental procedures - 1 Flowrate (ml/h) t Definitions t the total duration of the test from start to finish t 0 t 1 t 2 Error A Error B 1 st hour 2 nd hour 3 rd hour t 0 analysis period as the first 2 h of the test period t 1 analysis period as the second hour of the test period t 2 analysis period as the last hour of the test period Error A period t 1 Error B period t 2 n number of collected data at sampling time 30 seconds 120 240 360 n data 19
Result of experiment - 1 Flow Generator: Infusion pump Flow STD Standard Error flow Deviation Uncertainty Accuracy (ml/h) (ml/h) (ml/h) (ml/h) (ml/h) (%) (%) 10 9.965-0.024 0.193 0.484 4.84 5.22 100 96.596 0.164 0.073 0.285 0.285 0.337 300 280.169 1.529 0.037 0.532 0.177 0.540 Flow Generator: Level tank Flow STD flow Error Standard Deviation Uncertainty Accuracy (ml/h) (ml/h) (ml/h) (ml/h) (ml/h) (%) (%) 10 11.568-0.063 0.0854 0.536 5.36 5.46 100 101.358 0.195 0.0421 0.225 0.225 0.301 300 296.398 1.500 0.144 0.732 0.244 0.558 20
Experimental procedures - 2 Infusion pump Supply tank Set Flowrates (ml/h) 20, 100, 300 Coriolis mass flow meter Coriolis mass flow meter Model: M13 Flow range: (1 1200) ml/h Weight Balance (Period of time 30 s) Result of Experiment 2 [CMC of the flow facility] 21
Result of experiment - 2 M13 (Transfer standard) and weight balance Flow STD flow Error Standard Deviation Uncertainty Accuracy (ml/h) (ml/h) (ml/h) (ml/h) (ml/h) (%) (%) 20 20.119 0.648 0.198 0.219 1.095 3.56 100 98.226 0.018 0.119 0.174 0.174 0.212 300 289.16-0.069 0.135 0.786 0.262 0.267 22
Experimental procedures - 3 Infusion pump Supply tank Set Flowrates (ml/h) 10, 100, 300 Coriolis mass flow meter Infusion pump analyzer Result of Experiment 3 [Analyzer calibration] 23
Result of experiment - 3 Flow STD flow M13 and Infusion pump analyzer Error Standard Deviation Uncertainty Accuracy (ml/h) (ml/h) (ml/h) (ml/h) (ml/h) (%) (%) 20 20.303 0.364 0.086 0.962 4.81 5.16 100 99.281 0.290 0.038 0.599 0.599 0.666 300 290.6 1.046 0.882 1.400 0.467 0.653 24
Conclusion Experiment 1 Infusion pump VS Level tank Experiment 3 >> Accuracy = 1.0% Experiment 2 >> U = 0.30% 25
Future Plan Experiment 2 >> U = 0.30% Experiment 3 >> Accuracy = 1.0% Budget 100,000 USD Proficiency Test Intercomparison 26
Infusion pump analyzer calibration at NIMT Dr. Theerarak Chinarak Email: theerarak@nimt.or.th Changping, Beijing, China (Thailand) 31 st October, 2015