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METRON QA-IDS User & Service Manual

Infusion pump tester
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Q A - I D S
U s e r & S e r v i c e M a n u a l
Q A - I D S I n f u s i o n P u m p T e s t e r
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Summary of Contents for METRON QA-IDS

  • Page 1 Q A - I D S U s e r & S e r v i c e M a n u a l Q A - I D S I n f u s i o n P u m p T e s t e r...
  • Page 2 METRON warrants that the QA-IDS Infusion Pump Tester will substantially conform to published specifica- tions and to the documentation, provided that it is used for the purpose for which it was designed. METRON will, for a period of twelve (12) months from date of purchase, replace or repair any defective analyzer, if the fault is due to a manufacturing defect.

  • Page 3: Table Of Contents

    Table of Contents MANUAL REVISION RECORD....................5 1. INTRODUCTION........................7 1.1 QA-IDS Features .........................7 1.2 Specifications..........................7 1.3 General Information........................8 2. INSTALLATION........................9 2.1 Receipt, Inspection and Return.....................9 2.2 Setup............................10 2.3 Power ............................10 2.4 PRO-Soft QA-IDS........................10 3. OPERATING QA-IDS......................13 3.1 Control Switches and Connections.....................13 3.2 Key Pad Functions........................14...
  • Page 4 6.10.10 Processor board Schematic Diagram 10 (Pressure Sensor and Temperature) ....51 6.10.11 Processor board Schematic Diagram 11 (Main Part) ............58 6.10.12 Processor board Schematic Diagram 12 (Keyboard, Pressure Sensor and Pump Index) ................................59 APPENDIX B: ERROR REPORT FORM, QA-IDS............62 APPENDIX C: SUGGESTION FORM, QA-IDS...............65...

  • Page 5: Manual Revision Record

    Manual Revision Record This record page is for recording revisions to your QA-IDS User and Service Manual that have been published by METRON or its authorized representatives. We recommend that only the man- agement or facility representative authorized to process changes and revisions to publications: •...
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  • Page 7: Introduction

    Flow measurements are taken every 30 seconds, so that the measurements are independent of the infusion pump’s flow rate. Test results, shown in the QA-IDS's LCD display, can be printed out directly, or transferred to a PC via the PRO-Soft QA-IDS test auto- mation software.

  • Page 8: General Information

    Depth 24.5 cm / 9.65 in. Weight 4.30 kg / 9.48 lbs. Printer Port Centronics Interface Standard Accessories User and Service Manual QA-IDS (P/N 15035) Additional Accessories Carrying case (P/N 15100) Carrying case, ext. printer (P/N 10500) PRO-Soft QA-IDS software...

  • Page 9: Installation

    Repack the unit in a manner to ensure that it cannot shift in the box during shipment. METRON’s product warranty is on page ii of this manual. The warranty does not cover freight charges. C.O.D. will not be ac- cepted without authorization from METRON A.S or its represen-...

  • Page 10: Setup

    2. If PRO-Soft QA-IDS is being used, attach an RS-232 (null modem/data transfer configured) cable to the 9-pin D-sub outlet port located at the rear of the QA-IDS. Do not attach the printer cable to the QA-IDS. See below. However, if...
  • Page 11 Each of the QA-IDS tests can be run independently from PRO-Soft in the “Manual” test mode. Results are shown on the PC screen dur- ing testing, and the user is prompted to set the tested equipment ac- cordingly. At the conclusion of tests, the user may print a report, store the test and results on disk, or both.
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  • Page 13: Operating Qa-Ids

    3. Operating QA-IDS This chapter explains the operating controls, switches and menus of the QA-IDS, details how to use them in testing, and provides in- structions for printing reports, and operator maintenance. 3.1 Control Switches and Connections Front Panel Key Pad 11 alphanumeric keys, used to enter information.

  • Page 14: Key Pad Functions

    3.3 Menu and Function Keys The QA-IDS uses displays, function keys and a keypad to provide flexibility and control over operations. The top three lines in the dis- play are used for messages, status and results. The menu bar is shown at the bottom of the display.

  • Page 15: Display Menus And Messages

    3.4 Display Menus and Messages 1. Startup Screen. The following screens will be displayed in sequence for the first two seconds after the QA-90 has been switched ON. 2. Main Menu This window offers the following functions: • Press Occlusion Test (F5) to go to the Occlusion Test Setup Screen.
  • Page 16 • Press Establishment (F5) to record the establishment. • Press MAIN MENU (F4) to return to the main menu. • Press MORE (F1) and the following display will appear: • Press Serial no (F7) to record the serial number of the QA- IDS being used.
  • Page 17 • Press Flow Set (F7) to set the preset value of the infusion pump. • Press Alarm Prsr (F6) to set the preset pump value. • Press START (F2) to start the Occlusion Test, and the fol- lowing display will appear: The following parameters are displayed: Prsr: The pressure in the connction tube.
  • Page 18 Average value during the test interval is displayed. Rec- ommended dT from IEC is 30 sec, and this is the mini- mum value to be selected on the QA-IDS. Maximum dT is 600 sec. or 10 minutes. Default value is 30 sec.
  • Page 19 • Press MAIN MENU (F4) to return to the Main Menu. • Press START (F2) to start flow measurement, and the Flow Measurement 1 display will appear: The following parameters are displayed: Mean Flow: The flow of the liquid volume in infusion pump every second displayed in ml/h and %.

  • Page 20: Printing Test Reports

    Hard copy printouts of test results can be made if a printer is con- nected to the QA-IDS. See paragraph 2.2 for connecting the printer. To obtain a printout of the test, select PR HDR (F3) at the comple- tion of the test.
  • Page 21 2. Example Printout of an Occlusion Test. METRON QA-IDS Infusion pump tester Ver. Serial no.: 1.17 Operator Establishment - - EQUIPMENT INFORMATION - - Equipment Code ___________________________________________ Serial no. ___________________________________________ Status ___________________________________________ Group ___________________________________________ Manufacturer ___________________________________________ Type ___________________________________________ Model ___________________________________________...

  • Page 22: Operator Maintenance

    Allow the mixture to remain in the system for 30 minutes. • Drain the unit, as above • Repeat this procedure two to three times. • Set the QA-IDS on a one-hour flow test, with a flow rate of 100 ml/hr, using distilled water.

  • Page 23: Infusion Pump Testing

    30 seconds. The minimum volume detection of QA-IDS is 0.72 µl. That means that less than 1 µl is needed for QA-IDS to detect any sudden flow change between 0.10 ml/hr and 1000.0 ml/hr. QA-IDS performs flow-samplings every second for all flow rates.
  • Page 24 WAR NI NG Do not start measuring with the QA-IDS without having liquid in the system, as it may be exposed to wear. IMPOR TA NT METRON recommends sterile, distilled water in test use, as tap water may contain too much oxygen, and potentially destructive deposits.

  • Page 25: Occlusion Pressure/Bolus Volume Testing

    • Start the infusion pump with a high flow rate. Keep the CAUTION QA-IDS working until there is no more air in the tubes. Prime the unit properly. Timeout is max. 10 minutes. • Press GO BACK (F1) to return to the main menu.

  • Page 26: Infusion Flow Rate And Volume Testing

    Average value during the test interval is displayed. Rec- ommended dT from IEC is 30 sec, and this is the mini- mum value to be selected on the QA-IDS. Maximum dT is 600 sec. or 10 minutes. Default value is 30 sec.
  • Page 27 • Press Flow Set (F7) and enter the preset value of the infu- sion pump being tested. • Press Press Set (F6) and enter in the relevant + or - back- pressure. • Press dT (F5) if values other than the default 30 seconds is desired, and enter the new value.
  • Page 28 • Press MORE (F1) and the Flow Measurement 2 display will appear. The following parameters will then be displayed: Inst. Flow: Instantaneous Flow shows: max. value > mean value and minimum value in percent (%). Inst. Flow: Instantaneous Flow shows: max. value > mean value and minimum value in milliliters per hour (ml/h).

  • Page 29: Control And Calibration

    5. Control and Calibration This chapter explains the QA-IDS maintenance procedures, includ- ing testing and calibration. 5.1 Required Test Equip- ment • Digital multimeter, 10 µV resolution, 0.1% accuracy. • Pressure/vacuum generator, - 400 to + 1700 mmHg pressure. • Pressure gauge.

  • Page 30: Testing Pressure Gauge Accuracy

    5.5 Testing Flow Rate Accuracy 1. Set QA-IDS to do a Flow Measurement, with a set flow rate (Flow Set) of 100 ml/hr, a back pressure setting (Press Set) of 0 mmHg, and a sampling interval (dT) of 30 seconds.

  • Page 31: Checking The Battery Backup

    ± 50 ml 5.6 Checking the Battery Backup 1. In the SETUP menu, check the clock for date and time. Correct if necessary. 2. Turn the QA-IDS OFF, then ON again, and verify that the cor- rect date and time are displayed.
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  • Page 33: Component Functions And Parts

    1 x 3-conductor and 1 x 2-conductor. 6.1 Theory of Operation The QA-IDS is an infusion pump tester that runs on 110 - 230 V AC mains voltage. The unit is based on a Motorola microprocessor. Controls on the front panel of the unit allow testing of all the func- tions of an infusion pump.

  • Page 34: Serial Port

    6.7 Pump The QA-IDS has a pump from Saphierwerk, driven by a stepper mo- tor. The pump is a rotating piston pump with the pump head and pis- ton in artificial sapphire. It pumps 50 µl per revolution. The pump has a circuit board with a Hall sensor to provide an index per revolu- tion.

  • Page 35: Control Panel

    control the current drawn. The motor drivers are supplied with 24V to achieve rapid current increase and good torque. Each phase of the motor can be supplied with up to 1.5 A, which is regulated by the software independently of the step rate. U1840 is used for synchro- nizing the pulse width modulation to the drivers to prevent high peak values in the current drawn.
  • Page 36 COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE Resistor 47R 0.25W R1B1C Resistor 100R 0.25W R1215 Resistor 330R 0.25W R1B1D Resistor 470R 0.25W R1B27 Resistor 680R 0.25W R161 Resistor 1k 0.25W R1B21, R1B25, R1214, R1253, R1421, R1825, R1835, R1844 Resistor 1k3 0.25W R1B11 Resistor 2k0 0.25W...
  • Page 37 COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE MX single row 3 pin 1M RPL J110, J1210 Connector 5pin 3.9 mm J180 Connector 2 pin 3.9 mm J140 2 pin S1250- S1252, S1260...
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  • Page 39: Appendix A: Diagrams

    APPENDIX A: DIAGRAMS Processor Board Component Location....................Processor Board Schematic Diagram 1....................Processor Board Schematic Diagram 2 (Digital Part)................Processor Board Schematic Diagram 3 (CPU)..................Processor Board Schematic Diagram 4 (Memory)................Processor Board Schematic Diagram 5 (RS232C and Printer)............Processor Board Schematic Diagram 6 (Digital Outputs)..............Processor Board Schematic Diagram 7 (Digital Inputs)..............
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  • Page 41: Processor Board Component Location

    Processor board Component Location...

  • Page 42: Processor Board Schematic Diagram 1

    6.10.1 Processor board Schematic Diagram 1...

  • Page 43: Processor Board Schematic Diagram 2 (Digital Part)

    6.10.2 Processor board Schematic Diagram 2 (Digital Part)

  • Page 44: Processor Board Schematic Diagram 3 (Cpu)

    6.10.3 Processor board Schematic Diagram 3 (CPU)

  • Page 45: Processor Board Schematic Diagram 4 (Memory)

    6.10.4 Processor board Schematic Diagram 4 (Memory)

  • Page 46: Processor Board Schematic Diagram 5 (Rs232C And Printer)

    6.10.5 Processor board Schematic Diagram 5 (RS232C and Printer)

  • Page 47: Processor Board Schematic Diagram 6 (Digital Outputs)

    6.10.6 Processor board Schematic Diagram 6 (Digital Outputs)

  • Page 48: Processor Board Schematic Diagram 7 (Digital Inputs)

    6.10.7 Processor board Schematic Diagram 7 (Digital Inputs)

  • Page 49: Processor Board Schematic Diagram 8 (A/D)

    6.10.8 Processor board Schematic Diagram 8 (A/D)

  • Page 50: Processor Board Schematic Diagram 9 (Stepper Motor And Drivers)

    6.10.9 Processor board Schematic Diagram 9 (Stepper Motor and Drivers)

  • Page 51: Processor Board Schematic Diagram 10 (Pressure Sensor And Temperature)

    6.10.10 Processor board Schematic Diagram 10 (Pressure Sensor and Temper- ature)

  • Page 53: Processor Board Schematic Diagram 11 (Main Part)

    6.10.11 Processor board Schematic Diagram 11 (Main Part)

  • Page 55: Processor Board Schematic Diagram 12 (Keyboard, Pressure Sensor And Pump Index)

    6.10.12 Processor board Schematic Diagram 12 (Keyboard, Pressure Sensor and Pump Index)
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  • Page 58: Appendix B: Error Report Form, Qa-Ids

    APPENDIX B: ERROR REPORT FORM, QA-IDS QA-IDS INFUSION PUMP TESTER ERROR REPORT FORM USA _ FRANCE NORWAY 1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1 Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, Norway Phone: (+1) 888 863-8766...
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  • Page 60: Appendix C: Suggestion Form, Qa-Ids

    APPENDIX C: Suggestion Form, QA-IDS QA-IDS INFUSION PUMP TESTER SUGGESTION FORM USA _ FRANCE NORWAY 1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1 Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, Norway Phone: (+1) 888 863-8766...
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