baxter 35700BAX Preventive Maintenance
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baxter 35700BAX Preventive Maintenance

baxter 35700BAX Preventive Maintenance

Sigma spectrum infusion pump with master drug library
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Preventive
Maintenance
SIGMA SPECTRUM INFUSION PUMP WITH
MASTER DRUG LIBRARY
35700BAX
Pump Operating Software Version 6.02 and 6.05
For use with Master Drug Library Version 6
41394 Rev. A
July 2017

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  • Page 1 Preventive Maintenance SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY 35700BAX Pump Operating Software Version 6.02 and 6.05 For use with Master Drug Library Version 6 41394 Rev. A July 2017...
  • Page 2 Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance ©2017 Copyright Baxter Healthcare Corporation 711 Park Avenue Medina, New York 14103 T 800.356.3454 F 888.894.7794 www.sigmapumps.com...

  • Page 3: Table Of Contents

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance Preventive Maintenance ......... . 1 Preventive Maintenance and Frequency .
  • Page 4 Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance...

  • Page 5: Preventive Maintenance

    After each operation in this procedure, record the results on a copy of the “Preventive Maintenance Check Sheet” on page 20. SIGMA Spectrum Technical Training is available, but not required, for performing Pump NOTE: PM. Contact MedinaTechTraining@baxter.com for more information. Preventive Maintenance and Frequency PM consists of: Scheduled inspections, testing, and performance evaluations ■...

  • Page 6: Pump Identification

    Perform the inspections, tests, and performance evaluations described in this chapter. ■ Record the test result findings. ■ Return any Pump to Baxter that fails any inspection or test. ■ Pump Identification Serial Number and Operating Software Version The Pump’s serial number and operating software version are located in two areas, the Power Status screen and the User Options screen.

  • Page 7: Active Drug Library

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 2. Select Biomed Options and press OK. 3. Enter the Biomed password and press OK. 4. Select Network Configuration and press OK. 5.

  • Page 8: Visual Inspection

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance The Power Status screen (the Pump must be powered off): 1. Press ON/OFF to power on the Pump and view the current software version and serial number. 2. Record the Pump’s active Drug Library BDL file on the Preventive Maintenance Check Sheet. 3.

  • Page 9: Visual Inspection - Ac Power Adaptor

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 Pump Case  Pump Display  Keypad  Keyhole  Pump Door  IV Set Tube Channel  Pole Clamp  External Power Adaptor/Accessory Connection port ...

  • Page 10: Preventive Maintenance Pump Tests

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance 3. Verify that the green LED on the AC Power Adaptor is lit while plugged in and a plug icon appears on the Pump’s Charging screen. 4. Verify legibility of all labels on the AC Power Adaptor Module. 5.

  • Page 11: Equipment Required

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 CAUTION Perform Preventive Maintenance Annually. Pumps should be tested for proper performance annually and also whenever damage from drops, fluid intrusion and other causes is suspected.

  • Page 12: Keypad Operation Test

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance Keypad Operation Test To check the Pump keypad and display for proper operation: 1. Plug the AC Power Adaptor into a working wall outlet, or install a Battery Module. 2. Press ON/OFF to power on the Pump. 3.

  • Page 13: Memory Test

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 Memory Test To test the Pump’s memory: 1. Plug the AC Power Adaptor into a working wall outlet, or install a Battery Module. 2.

  • Page 14: Pump Operation Tests

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance Pump Operation Tests The Pump operation tests include: Downstream (Distal) Occlusion Sensor ■ Upstream (Proximal) Occlusion Sensor ■ Gravimetric or Volumetric Flow Rate Accuracy ■ Air Detection ■ Test Setup To prepare the Pump for testing: The IV sets being used for testing the Pump must be compatible with the Pump NOTE:...
  • Page 15 SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 1. Attach the pole clamp to a stable IV pole. The drip chamber filled to fill line. 610 ± 51 mm (24 in ± 2 in) between the top of the fluid level and the center of the Pump.

  • Page 16: Downstream (Distal) Occlusion Sensor Test

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance 10. Inspect the IV tube channel. Confirm that it is free of foreign materials and dry for both testing and use. 11. Load the IV set into the Pump following the Direction of Flow diagram inside the Pump door, and close the door.
  • Page 17 SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 16. Select Primary Bag and press OK. 17. For Mode select mL/hr and press OK. 18. Set the Rate to 100 mL/hr and press OK. 19.

  • Page 18: Upstream (Proximal) Occlusion Sensor Test

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance The pressure gauge should be at the same height as the Pump. NOTE: 22. Press RUN/STOP to start the infusion. The Pump may indicate BAG NEAR EMPTY <30 MIN REMAIN. Press OK to NOTE: silence this alarm.

  • Page 19: Flow Rate Accuracy Test

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 If the Pump displays a Check Flow screen, press the yes soft key to proceed to the NOTE: Infusion Running Screen. 12.
  • Page 20 If the test procedure fails, review the test set up to ensure that the process has been  followed correctly. Install a new approved IV set and repeat the test. If the error repeats, contact Baxter technical support and service at:  Telephone: 800.356.3454 or ...

  • Page 21: Air Detection Test

    If the test procedure fails, review the test set up to ensure that the process has been  followed correctly. Install a new approved IV set and repeat the test. If the error repeats, contact Baxter technical support and service at:  Telephone: 800.356.3454 or ...

  • Page 22: Battery Capacity Test

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance 18. Press RUN to resume infusion. The Check Flow screen appears. 19. Press the yes soft key to proceed to the Infusion Running screen. 20. Press RUN/STOP to stop the infusion. In the event of a test failure, confirm failure by repeating the test with a new NOTE: (unused) IV set.
  • Page 23 SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 15. When the “Load tube into pump and push OK to continue” confirmation screen appears, press 16. Enter or verify 125 mL/hr for Rate and press OK. 17.

  • Page 24: Preventive Maintenance Check Sheet

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance Preventive Maintenance Check Sheet When using the Annual Preventive Maintenance Check Sheet: Enter the Hospital/Facility name in the space provided. ■ Enter the Biomed name and date of the test. ■...

  • Page 25: Pump Inspection

    SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 Pump Inspection Inspection Pass Fail Visual Inspection - Pump Inspect the Pump for visual signs of damage and damage to all exterior components such as dents, cracks, cuts, heat damage or fluid intrusion.

  • Page 26: Preventive Maintenance Tests

    Manual 41394 SIGMA Spectrum Infusion System Revision A Preventive Maintenance Preventive Maintenance Tests Tests Performed Pass Fail Keypad Test Perform the keypad test for proper key operation. Pass criteria: All keys work as intended  Memory Test Pass criteria: Rate and VTBI parameters were saved. ...
  • Page 27 SIGMA Spectrum Infusion System Pump Operating Software Version 6.02 and 6.05 Preventive Maintenance For Use With MDL Version 6 Tests Performed Pass Fail Air Detection Test Pass criteria: All steps completed successfully.  Pump goes into Air in Line alarm. ...

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