Test Report Project Nr. 2013/020

Transcription

1 PISTON Ltd Budapest Szőlőkert u. 4./B HUNGARY Tel: Fax: http: (361) (361) Test Report Project Nr. 2013/020 Name and address of Applicant Name and address of Test Laboratory Quality Management System Piston Ltd. H-1033, Budapest, Szőlőkert u. 4/B Piston Ltd. H-1033, Budapest, Szőlőkert u. 4/B ISO 9001 and ISO by SGS Hungaria Kft. Systems & services certification Device under test: Pulmonary Waveform Generator Type: PWG-33BT Serial Nr.: PWG-33-BT Name and address of Manufacturer Standards applied Piston Ltd. H-1033, Budapest, Szőlőkert u. 4/B Safety requirements for electrical equipment for measurement, control, and laboratory use EN Standardisation of Spirometry by American Thoracic Society, 2005 Peak expiratory flow meters EN ISO 23747:2009 Spirometers intended for the measurement of time forced expired volumes in humans EN ISO 26782:2009 Duration Start of test: 18th April 2013 End of test: 19th April 2013 Test result Tested by The requirements are met Checked by 19th April 2013 Tamas HANKÓ Date Name Signature 19th April 2013 Ákos TÓTH Date Name Signature This test report relates to a.m. test item. Without permission of the test centre this report is not permitted to be duplicated in extracts. Test report Page 1 PWG-33BT

2 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 1. Measuring equipment Item Device Manufacturer Type Serial Nr. Next calibration 1 High Voltage Test SGS Electronic HA 3300A May Safety Test Equipment Piston Ltd. KT Feb Micrometer MOM A Apr Inside micro calliper Bowers Metrology XTA175M 8019 Apr Calliper rule MOM 330 mm 4986 Apr Linear displacement transducer 7 Rolling seal spirometer Novotechnik LWH B Mar 2015 VO-12 (9 litre) ID=300 mm NC 8 Digital manometer Valydyne CD Nov Digital event counter Gold Star FC 2015U May ADC for IBM/PC Keithley DAS-1800HR NC 11 PWG test software Piston Ver NC Test report Page 2 PWG-33BT

3 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 2. Safety test 2.1. High tension test The requirement is met The High Voltage test (Device Item #1) is used for high voltage tension test Applied to Voltage Result Shortened mains terminals Earth cable 1.5kV OK Shortened mains terminals Accessible metal parts 1.5kV OK 2.2. Earth system resistance The requirement is met The Safety test (Device Item #2) is used for Earth resistance measuring Nominal current Applied to Resistance* 25 A Earth connector Earth centre connector Ohm 25 A Earth connector Cylinder Ohm 25 A Earth connector Metal case Ohm * without mains cable 2.3. Leakage current test The requirement is met The Safety test (Device Item #2) is used for Leakage current measuring. The protective earth conductor is interrupted during the measurements. Connection Earth leakage current Cover leakage current supply conductors are connected Earth leakage current Cover leakage current one of the supply conductor is interrupted Normal 2.86 ma 2.85 ma 5.65 ma 5.64 ma Inverse 2.85 ma 2.84 ma 5.64 ma 5.64 ma Test report Page 3 PWG-33BT

4 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 3. Test methods Accuracy test of the PWG can not be performed directly because there is no available device, which could measure flow and volume with accuracy higher with one order of magnitude than PWG. That s why the test is divided into four steps: check of mechanical sizes, leakage, kinematics test and functional test with a spirometer. In this way all generated waveforms can be checked and all measured values are traceable to the National Standards. Mechanical size checking is to measure all important sizes, which influent the accuracy of PWG Leakage test is to check the integrity of pneumatic system Kinematics test is to measure the accuracy and precision of piston movements in square wave and ATS curve modes 4. Summary of test results 4.1. Mechanical size checking The requirement is met The internal diameter of the cylinder is measured at different positions and different angles with the three point Inside micro calliper (Device Item #4). Test is accepted if both Precision and Deviation is less or equals to 0.1% Position [l] ID Reference [mm] ID ID Average [mm] Precision [%] Deviation [%] The linear displacement of the piston is measured with the Calliper rule (Device Item #5) after executions of different number of steps. Test is accepted if both Precision and Deviation is less or equals to 0.1% Number of steps Volume [l] Reference [mm] #1 Measure [mm] #2 Measure [mm] #3 Measure [mm] Average [mm] Precision [%] Deviation [%] Test report Page 4 PWG-33BT

5 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 4.2. Leakage test The requirement is met During the Leakage test the whole pneumatic system of the PWG is checked and the total inner surface of the syringe is scanned in four steps with overlaps. The leakage test is performed for both direction of piston movement. The piston of the PWG is pulled to the basic position Syringe Calibrator (Device Item #7) is turned to the vertical position and biased at about 0.2 litre The Syringe Calibrator is connected to the pneumatic outlet of the PWG Appropriate weight is placed over the moving part of the Syringe Calibrator to achieve the desired test pressures Test pressure is measured by Syringe Calibrator Syringe Calibrator is zeroed Using the service application piston is pushed and pulled at a moderate constant speed 2x10 times to the end positions. Total time of the test should last about 60 seconds The end position of the Syringe Calibrator is read and the difference of the basic position and the end position gives the leakage of the total pneumatic system Test is accepted if the leakage for each direction less than 10 ml Basic position Test volume Test speed Leakage [l] [ml] [l/s] [ml] , Total leakage: 8.98 Pressure Total leakage Number of cycles Effective leakage [Pa] [ml] [ml] Test report Page 5 PWG-33BT

6 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 4.3. Pressure transducer calibration The requirement is met Summary of Method: A pressure transducer and a standard pressure gauge (Device Item #8) are connected to a pressure source. Pressure is applied in predetermined increments over the full range of the pressure transducer. The pressure transducer output is compared at each increment to a pressure gauge reading. The percent deviation of the pressure transducer when compared to the pressure gauge reading is calculated for each pressure increment over the full range calibrated. From these percent deviation values. a determination is made to accept or reject the pressure transducer for use. Test is accepted if the deviation of the pressure transducer is less then 2.0 %. Pressure applied [Pa] Measured pressure [Pa] Deviation [Pa] Deviation [%] Test report Page 6 PWG-33BT

7 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 4.4. Kinematics test The requirement is met The accuracy of PWG should be checked at the constant speed with different pneumatic loads. The Digital event counter (Device Item #9) is connected to the lower BNC output [Gated 1 MHz] of the PWG All the 8 pre-set square waves are generated and the time interval is measured between the built in photo interrupters Measurement is repeated four times; twice without load and twice with the artificial laminar flow element supplied with the PWG Test is accepted if both Precision and Deviation is less or equals to 0.3% Error analysis of measuring component: Allowed tolerance of PWG Trigger error of photo interrupter 0.1% 0.1% Readout error of Digital event counter Total allowed error range 0.1% 0.3% Basic parameters: Step Volume Distance of photo interrupters (dedicated value for each device) 1 MHz generator period ml steps µs PEF Nominal Tgate Nominal Pulse M1 M2 M3 M4 Average Deviation Precision [l/s] [ms] [pulse] [pulse] [pulse] [pulse] [pulse] [pulse] [%] [%] R=0 Pa/l/s R=0 Pa/l/s R=160 Pa/l/s R=160 Pa/l/s Load Test report Page 7 PWG-33BT

8 Piston Ltd. Hungary 1033 Budapest, Szőlőkert u. 4/B 4.5. ATS Volume(time) and ATS Flow(time) curve test The requirement is met The rod of the high precision Linear displacement transducer (Device Item #6) is fastened to the rod of the piston and its outputs connected to the ADC for IBM/PC (Device Item #10). Signals are acquired and analysed by the PWG test software (Device Item #11). The four basic pulmonary parameters are calculated and compared to the reference values prescribed by ATS. Measurements are repeated twice: once without load and once with the artificial laminar flow element supplied with the PWG. The FEV1/FVC is omitted because it is derived from FEV1 and FVC which are evaluated separately The Back pressure is not measured at this test but the default value (10 kpa) is shown in the result table Test is accepted for volume parameters if the Absolute accuracy is better than 18 ml. Error analysis of measuring component: Component Allowed tolerance of PWG Linearity error of Linear displacement transducer Linearity error of ADC for IBM/PC Total allowed error range Absolute accuracy 10ml 4ml 4ml 18ml Test report Page 8 PWG-33BT

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