Info V.A.C. Quality Control Checklist March 2010

InfoV.A.C.® QUALITY CONTROL CHECKLIST Asset / Serial #:

Location:

Shake test ok Electrical Safety Stickers valid and dates match. Perform electrical safety test if less than 2 months to expiry GENERAL 1. Exterior of the Therapy unit is clean and undamaged 2. Ensure power and canister buttons are legible 3. AC Cord and Power Supply are clean and undamaged (Ensure pins secure and cable sheath in good condition) 4. Is battery due for replacement (check battery maintenance sheet)
No – Proceed to next step
Yes – Return unit for repairs 5. Ensure the canister seals (PN M4242003) are in place, clean and undamaged 6. Inspect all labels on unit, adaptor and cord. Replace any damaged or missing labels 7. Verify that the Hanger Arm assembly is secure and operates correctly. Ensure hanger rubber block is present 8. Verify the stylus (PN M3268567) is inside the UDI Door and is clean and undamaged 9. Disconnect Power Supply if attached and turn unit on. Use battery mode for all tests until Final Settings Procedure OPERATION 10. Verify that the screen comes on. Check screen for scratches or damage. Press ‘OK’ when prompted 11. Ensure unit is in clinician mode 12. Observe Time / Date in top right corner. If incorrect adjust time / date as required 13. Ensure the battery symbol is displayed 14. Engage test canister and verify it will fit securely 15. Connect canister to manometer and ensure it is zeroed 16. Press ‘?’ – ‘About’ – ‘Wrench’ – ‘Access Code’ – ‘OK’ (twice) 17. Press ‘Calibrate Sensors’. Is Pump flow within +/0.1lpm.
Yes – Proceed to next step
No – Remove canister and press ‘Zero Pressures’. If pump flow is still outside tolerance return unit for service 18. Press ‘Exit’ then ‘Therapy’ 19. Calibration Check. Turn therapy on & use the set pressures listed below and record wound pressure on unit and manometer pressure readings below. Ensure both wound and pump readings are within tolerance of +/6mmHg each other. Wound and manometer readings should also be within +/-6mmHg of each other Set Pressure

Unit Reading

Manometer Reading

125mmHg

_______mmHg

_______mmHg

200mmHg _______mmHg _______mmHg 20. Press ‘On/Off’ to turn therapy off and ensure the pressure drops to below 30mmHg within 10 seconds 21. Press ‘Exit’ – Misc. Check Default Mode is set to ‘Mode at Shut Down’ 22. Check KCI Contact Number and update if required 23. Press ‘Exit’ – ‘Exit’ to go back to home screen ALARMS 24. LEAK ALARM – Remove tubing cap from canister. Turn Therapy on and unit should alarm in approx 2 minutes. Press ‘Reset’ 25. BLOCKAGE ALERT – Clamp Tubing. Alert should occur in approx 2 minutes. Press ‘Reset’ 26. CANISTER NOT ENGAGED ALARM – Turn Therapy off. Disengage canister from unit. Turn Therapy back on and unit should alarm in less than 30 seconds. Press ‘Reset’ – ‘Exit’

OPS-450

27. CANISTER FULL ALARM – Place tubing cap over canister seal closest to screen. Turn Therapy on. Unit should alarm Canister Full in less than 90 seconds. Make sure the audible alarm is okay. Press ‘Reset’ – ‘Exit’ Patient History - DATA TRANSFER 28. Use test SD Card to upload test image to device 29. Use test USB Stick to download (export) history 30. Ensure both SD Card and USB Stick are removed from the device FINAL SETTINGS AND PACK 31. Connect unit to AC Supply, ensure that the on screen indicator and battery charging indicator (rear of product) both illuminate 32. Ensure the battery charging indicator is lit either amber or green. If any other colour return unit for service 33. Press ‘?’ – ‘About’ – ‘Wrench’ – ‘Access Code’ – ‘OK’ (twice) 34. Press ‘Logs’ – ‘Restore Defaults’. Then Press and Hold ‘Restore Defaults’ 35. Press ‘Exit’ – ‘Exit’ 36. Ensure unit has adequate charge (>50%) for unit placement
Yes – Switch unit off and proceed to next step
No – Switch unit off and charge unit for a minimum of 2 hours 37. Ensure the user manual is placed in transit case 38. Ensure a tubing cap (with at least 2 months to expiry) is included in the transit case (Rental only) 39. Place the same AC Cord and Power Supply used to test the unit into the transit case. Ensure the connectors are not bent or stressed when storing or shipping 40. Unit placed into case and green tag attached to case

QUALITY CONTROL VERIFICATION CERTIFICATION BY: TECHNICIAN:_______________________Date:____/____/___ CLEANING AND QA DATA ENTERED INTO FLEET MANAGEMENT
Available
Unavailable In Repair
Other: __________________ ®

Safety Test – InfoV.A.C. Therapy System Insulation Resistance (>10MΩ)

______ MΩ

 Pass  Fail

Earth Leakage – Normal (< 500µA) ______ µA

 Pass  Fail

SFC Neutral Open (< 1000µA)

______ µA

 Pass  Fail

GWR – Power Cord (<200mΩ)

______ mΩ

 Pass  Fail

ELECTRICAL SAFETY TEST COMPLETED BY:

Available

TECHNICIAN:_________________________

Date: ____/____/____

Forms/~/Mar 2010