Attachment 6 - Biomerieux.pdf

Attachment 2 to 514692-4EN1 (12/2015)

PREVENTIVE MAINTENANCE CHECKLIST BacT/ALERT® 3D COMBINATION MODULE

Site Name Service Call #

Site Number Date

► 1. Perform required system updates. (Section 3.1)

Record system serial numbers (Section 3.1, Step 1):

Component Name Serial Number

Combination Module

Additional Incubator 1

Additional Incubator 2 N/A

Additional Incubator 3 N/A

Additional Incubator 4 N/A

Software version B.50 installed on instrument? (Section 3.1, Step 2) Yes No

Instrument upgraded to USB Port this PM? (Section 3.1, Step 9) Yes No N/A

Instrument updated to software version B.50 this PM? (Section 3.1, Step 12)

Yes No N/A

2. Perform Combination Module backup. (Section 3.2.1, Zip® Drive or Section 3.2.2, USB Flash Drive)

3. Perform database backup on the DBMS. (Section 3.3.1, BacT/VIEW® or Section 3.3.2, OBSERVA®)

► 4. Record Incubator temperatures below: (Section 3.4)

Location Temperature Set Point Value As Found Temperature As Left Temperature

Additional Incubator 1

± 0.5° C ° C ° C

Additional Incubator 2

N/A ± 0.5° C N/A° C N/A° C

Additional Incubator 3

N/A ± 0.5° C N/A° C N/A° C

Additional Incubator 4

N/A ± 0.5° C N/A° C N/A° C

5. Perform DBMS system and printer maintenance. (Section 3.5.1, BacT/VIEW® or Section 3.5.2, OBSERVA®)

6. Clean the DBMS computer and monitor. (Section 3.5.1, BacT/VIEW® or Section 3.5.2, OBSERVA®)

7. Perform Combination Module printer maintenance. (Section 3.6)

Line Item # 2

► 8. Perform Cell Check and Calibration. Record below, any cells with values >3.5%. Recalibrate those cells.

(Section 3.7)

Location Cells with values >3.5%

Additional Incubator 1

Additional Incubator 2 N/A

Additional Incubator 3 N/A

Additional Incubator 4 N/A

9. Perform Drawer function test. (Section 3.8)

► 10. Check Voltages. Record results below: (Section 3.9.1 and 3.9.2, if applicable)

Location Tolerance As Found Voltage As Left Voltage

Combination Module (Module Control Board JP11 red wire [+] black wire [-])

5.15 ± 0.05 VDC

Additional Incubator 1 (Module Control Board F3 and GND point 19)

5.2 ± 0.05 VDC

N/A N/A

Additional Incubator 2 (Module Control Board F3 and GND point 19)

5.2 ± 0.05 VDC

N/A N/A

Additional Incubator 3 (Module Control Board F3 and GND point 19)

5.2 ± 0.05 VDC

N/A N/A

Additional Incubator 4 (Module Control Board F3 and GND point 19)

5.2 ± 0.05 VDC

N/A N/A

11. Replace UPS battery every 3 years (Combination Module). Replaced this PM? Yes No

(Section 3.10.1, Step 4)

12. Replace UPS battery every 2 or 3 years, depending on the UPS in use (DBMS). Replaced this PM?

Yes No (Section 3.10.1, Step 6)

13. Verify the Combination Module’s cable connections are secure and not damaged. (Section 3.10.1, Step 9 and

Step 16)

14. Verify cooling fans are operational for Combination Module. (Section 3.10.1, Step 17)

15. Check the Combination Module’s four Solid State Relays connections. (Section 3.10.1, Step 22)

16. Check the rack mounting screws for each drawer. (Section 3.10.1, Step 35)

NOTE: Step 17 through Step 29 are for additional Incubation Modules only. If additional Incubation Modules are not installed, proceed to Step 30.

17. Verify each Incubator’s cable connections are secure and not damaged. (Section 3.10.2, Step 3)

18. Check each Incubator’s agitation motor for leaks. (Section 3.10.2, Step 4)

19. Check each Incubator’s three Solid State Relays connections. (Section 3.10.2, Step 9)

20. Check the rack mounting screws for each drawer. (Section 3.10.2, Step 19)

21. Check drawer guide rails are not bent or loose for each incubator. (Section 3.10.2, Step 21)

22. Check drawer shoes for tightness and cracks for each incubator. (Section 3.10.2, Step 24)

23. Check drawer pin is tight for each incubator. (Section 3.10.2, Step 26)

24. Verify no excessive noise from drawers for each incubator. (Section 3.10.2, Step 29)

25. Check drawer latch assembly for each incubator. (Section 3.10.2, Step 31)

26. Check blower motor operation for each incubator. (Section 3.10.2, Step 38)

27. Verify the cooling fans are operational for each incubator. (Section 3.10.2, Step 39)

► 28. DBMS UPS Functional Test. Record Below. (Section 3.11.1) N/A

UPS Outlet Voltage (wall power applied)

1.00 vac UPS Outlet voltage (wall power removed)

1.00 vac Difference must be ± 10% 0.00%

► 29. Combination Module UPS Functional Test. Record Below. (Section 3.11.2)

UPS Outlet Voltage (wall power applied)

1.00 vac UPS Outlet voltage (wall power removed)

1.00 vac Difference must be ± 10% 0.00%

► 30. Replace Reflective Standards every 2 years. Record information below. (Section 3.12)

Date listed on calibration sticker Reflective Standards replaced this PM? Yes No

31. Verify Combination Module (Signature Configuration) to DBMS communication. (Section 3.13)

32. Test modem for Combination Module and the DBMS (if installed). (Section 3.14)

33. Complete the PM maintenance certificate. (Section 3.16)

FSE Name FSE Signature

Notes:

VITEK® 2 and VITEK® 2 XL Preventive Maintenance Checklist

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

VITEK®2 System Software Version Instrument Firmware Version

BCB Boot SPN SCS VITEK®2 System 7.01, 8.01, 8.02, 9.02 or higher 4.064 0.12 2.17, 4.182, or 4.171

4.72

4.182, or

4.193 (VAC)

1 VITEK® 2 instruments with a molded incubator will have SPN FW version 4.17 or later in the carousel SPN board.

2 General SPN 4.18 is only available on Universal General SPN boards (including Universal Vacuum SPN boards). Universal SPN boards cannot be updated to 4.18 from the BCB. P/N 6200271 (6204040 RoHS) / 6200710 (6204040 RoHS).

3 SPN version 4.19 is for the Vacuum SPN board only. P/N 6200934 (6204041 RoHS) 4 Firmware version 4.06 allows the instrument to process 64 and 104 well cards. The VITEK® 2 instrument must be updated to BCB firmware version 4.06 prior to the 9.01 software update.

IMPORTANT: The software and instrument firmware versions shown in the above table are validated as a set.

Ensure the software version corresponds with the instrument firmware versions. Never mix older software and newer instrument firmware versions, or newer instrument firmware and older software versions.

IMPORTANT: Upon completion the VITEK 2 instruments should contain BCB 4.06 firmware. If an instrument contains BCB 3.92 firmware, execute the latest version of Design Note 17-017 prior to performing section 2.19 Create a Full System Backup.

Required Instrumentation Serial Number Absolute Pressure Gauge

Site Name Service Call #

Site Number Date

VITEK® 2 PC Software Version. OBSERVA® PC Software Version.

Inst. Serial # BCB Firm.

Boot SPN Vac

SPN Caro.

A B (XL only)

SPN Reader A B (XL only)

SPN

Pip

SPN

DiL

SPN

Left

SPN

Right

1. Check and record the VITEK® 2 PC software version. Record the software version. (PM Section 2.2.1 for Host PC – Check Software Version)

Software version:

2. Review the following for errors: SYS_STATUS, MESSAGES, and LOGS_AND_HISTORY. (PM Section 2.4, Step 1 and Step 2)

3. Review the following for errors: SEQ_STATUS, BOAT_STATUS, and COMP_STATUS. (PM Section 2.4, Step 3)

4. Perform SEQ_STATUS_RESET, BOAT_STATUS_RESET, and COMP_STATUS_RESET to reset the computations to zero. (PM Section 2.4, Step 4)

Line Item # 3

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

5. Perform DUMP_LOG 30. If the BCB firmware version is at 3.92, execute the latest version of Design Note 17-017 and update to BCB 4.06 firmware. Ensure the instrument firmware version correspond with the software version. (PM Section 2.4, Step 5 and Step 6)

6. Perform VER to confirm and then record the firmware version.

► 7. Perform pr $AVE_INCU_TEMP and verify Incubator temperature. (PM Section 2.4, Step 7) Record results below:

Location Range Instrument 1 Instrument 2

A B (XL only) A B (XL only)

U/I Reading

35.5 °C ± 1.0°C

Recorded Value:

Instrument 3 Instrument 4

A B (XL only) A B (XL only)

8. Perform FAN 100 and FAN 0. Verify instrument cabinet fans are working correctly. (PM Section 2.4, Step 8 and Step 9). Replace as necessary.

► 9. Perform COLD to reboot instrument. Check for the following errors - NWK Random Error [0x46] : Op Code was not GO – Unexpected message cmd = x instead of Dummy on node y errors. (PM Section 2.4, Step 10) SPN Replacement needed?

10. Shutdown and clean the Host PC. (PM Section 2.5)

► 11. Verify the Smart Carrier Station version(s). (PM Section 2.6)

12. Clean the Smart Carrier Station(s). (PM Section 2.7)

13. If applicable, replace the G2 SCS fan. The G2 SCS cooling fans MUST be replaced at least every 5 years.

(PM Section 2.8) Check if this step is N/A.

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

SCS # Serial # Generation (G2 or G3) SCS version

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

14. Clean the DENSICHEK® Plus or the VITEK® DENSICHEK®. (PM Section 2.9)

15. Clean the printer, monitor, keyboard, mouse, KVM and bar code reader. (PM Section 2.10)

16. If applicable, shutdown and clean the OBSERVA® PC. (PM Section 2.11) Check if this step is N/A.

► 17. Replace the UPS Battery every three years. Label the replaced battery with the replacement date. (PM

Section 2.13) Check if this step is N/A.

UPS Battery Replaced?

18. With instrument shutdown, clean the instrument exterior and general interior. (PM Section 2.15)

19. Clean the inlet fan filter. (PM Section 2.15, Step 6)

► 20. Replace cabinet fans every 5 years, or if it was determined previously in this procedure that they are not functioning properly. (PM Section 2.16) Replaced:

21. Clean and tighten power supply drawer components. (PM Section 2.17)

► 22. Replace the Power supply drawer fan every 5 years. (PM Section 2.18) Replaced:

23. Clean and inspect the transport system. (PM Section 2.19)

► 24. Perform transport assembly paddle belt check of all 4 instrument transport assemblies. (PM Section 2.20)

Paddle Belt replacement needed? (PM Section 2.21)

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Front Trans Yes No N/A Inst # 2 Front Trans Yes No N/A

Inst # 1 Left Trans Yes No N/A Inst # 2 Left Trans Yes No N/A

Inst # 1 Back Trans Yes No N/A Inst # 2 Back Trans Yes No N/A

Inst # 1 Right Trans Yes No N/A Inst # 2 Right Trans Yes No N/A

Inst # 3 Front Trans Yes No N/A Inst # 4 Front Trans Yes No N/A

Inst # 3 Left Trans Yes No N/A Inst # 4 Left Trans Yes No N/A

Inst # 3 Back Trans Yes No N/A Inst # 4 Back Trans Yes No N/A

Inst # 3 Right Trans Yes No N/A Inst # 4 Right Trans Yes No N/A

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

25. Clean and inspect the instrument base pan ribs. Replace if necessary. (PM Section 2.22)

► 26. Replace the sealer hot wire every 12 months. (PM Section 2.23) Replaced:

27. Verify the sealer connections. (PM Section 2.24.)

28. Clean and inspect the Diluter Fill Optical Sensor. (PM Section 2.25)

29. Clean, inspect, and lubricate the Diluter Solenoid Assembly. (PM Section 2.26 and Section 2.27)

►30. Replace the Diluter Pump Air Filter every 12 months. (PM Section 2.28)

►31. Replace the Diluter Intake and Exhaust Check Valves every 12 months. (PM Section 2.29)

32. Clean Pipettor, Replace Drum O-Rings, and Replace Straw Sensor Pad every 12 months. (PM Section 2.30)

►33. Replace the Pipettor flex cable (Replace every two years in high use pipettor systems (instruments processing >20,000 cards per year) or every 5 years for low to medium use pipettor systems).

(PM Section 2.31) Replaced:

34. Clean and inspect vacuum assembly. (PM Section 2.32)

35. Clean and inspect the Carousel. (PM Section 2.33)

►36. Replace Incubator fans every 5 years. (PM Section 2.34) Replaced:

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

► 37. Replace the Incubator Static Brush every 12 months. (PM Section 2.35) Check if this step is N/A.

38. Tighten the Ejector Tray Gear, Autoloader Drive Gear and the Cam Gear. (PM Section 2.36, Section 2.37, and Section 2.38)

39. Clean Autoloader Pusher. (PM Section 2.37)

40. Clean and Inspect the Transmittance Optics. (PM Section 2.39)

41. Replace Reader Head Drive Belt(s) and springs every 12 months. (PM Section 2.40.1 or Section 2.40.2)

42. Inspect the Reader Head Roller Plate(s). (PM Section 2.40) Replace if necessary. (PM Section 2.40.3)

43. Inspect the Reader Head Motor Drive Pulley. (PM Section 2.40) Replace if necessary. (PM Section 2.40.4)

► 44. Replace the Reader Ledge(s) every 24 months (on high volume instruments replace every 12 months).

(PM Section 2.41) Replaced:

45. Clean, inspect, and adjust the Stacker. (PM Section 2.42)

46. Perform UPS functional test. (PM Section 2.44)

47. Verify the Keyboard, Mouse, KVM switch, and Bar Code Reader are operational. (PM Section 2.46)

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Inst # 1 Yes No N/A Inst # 2 Yes No N/A

Inst # 3 Yes No N/A Inst # 4 Yes No N/A

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

► 48. Replace the BCB battery every 8 years. (PM Section 2.47) Replaced:

49. Perform Instrument Power Up Check. (PM Section 2.50)

50. Perform Diluter Pump Block Assembly Test. (PM Section 2.51)

51. Perform Pipettor Leak Test. (PM Section 2.52)

► 52 Perform Vacuum Calibration. (PM Section 2.53) Record results below:

Range Instrument 1 Instrument 2

Calibration Setting: 0.89 ± 0.04

PSIA.

Value: Value:

Value: Value:

53. Check/Calibrate Sealer Current. (PM Section 2.54) Record results below:

Range Instrument 1 Instrument 2

Calibration Setting: 8.5 ± 0.1 A. Value: Value:

Value: Value:

54. Align Sealer Assembly if sealer was replaced. (PM Section 2.55)

55. Run Engineering Cards and verify Instrument Alignment. (PM Section 2.56)

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

► 56. Perform the Transmittance Minimum Threshold Reading Test. (PM Section 2.57.1) Record results below:

Location Range Instrument 1 Instrument 2

Section A

TX 1

All values must be ≥ 3750.

Lowest value: Lowest value:

DAC values range 700-

Lowest value:

Highest value:

Lowest value:

Highest value:

TX 3

All values must be ≥ 3618.

Lowest value: Lowest value:

DAC values range 550-

Lowest value:

Highest value:

Lowest value:

Highest value:

Section B

TX 1

All values must be ≥ 3750.

Lowest value: Lowest value:

DAC values range 700-

Lowest value:

Highest value:

Lowest value:

Highest value:

TX 3 (If applicable)

All values must be ≥ 3618.

Lowest value: Lowest value:

DAC values range 550-

Lowest value:

Highest value:

Lowest value:

Highest value:

Location Range Instrument 3 Instrument 4

Section A

TX 1

All values must be ≥ 3750.

Lowest value: Lowest value:

DAC values range 700-

Lowest value:

Highest value:

Lowest value:

Highest value:

TX 3

All values must be ≥ 3618.

Lowest value: Lowest value:

DAC values range 550-

Lowest value:

Highest value:

Lowest value:

Highest value:

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

Location Range Instrument 3 Instrument 4

Section B

TX 1

All values must be ≥ 3750.

Lowest value: Lowest value:

DAC values range 700-

Lowest value:

Highest value:

Lowest value:

Highest value:

TX 3 (If applicable)

All values must be ≥ 3618.

Lowest value: Lowest value:

DAC values range 550-

Lowest value:

Highest value:

Lowest value:

Highest value:

57. Perform Head Controller Board Test (HCB). (PM Section 2.57.2) Passed:

Inst # 1 Section A

Yes No N/A Inst # 2 Section A

Yes No N/A

Inst # 1 Section B

Yes No N/A Inst # 2 Section B

Yes No N/A

Inst # 3 Section A

Yes No N/A Inst # 4 Section A

Yes No N/A

Inst # 3 Section B

Yes No N/A Inst # 4 Section B

Yes No N/A

► 58. Verify each DENSICHEK® Plus or VITEK® DENSICHEK®. (PM Section 2.58)

DENSICHEK® Plus calibrated. Record results below and confirm they are within the acceptable range:

N/A

Acceptable Ranges

0.5 McF 0.44 0.56

2.0 McF 1.85 2.15

3.0 McF 2.79 3.21

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

Serial number Standard 0.5 Standard 2.0 Standard 3.0

DENSICHEK®

Plus 1

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 2 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 3 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 4 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 5 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 6 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 7 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Plus 8 N/A

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Expiration Date:

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

VITEK® DENSICHEK® calibrated. Record results below and confirm they are within the acceptable range:

Acceptable Ranges

0 McF N/A

0.5 McF 0.39 – 0.61

2.0 McF 1.81 – 2.19

3.0 McF 2.675 – 3.25

Serial Number

0.5 McF

Standard

2.0 McF

Standard

3.0 McF

Standard

VITEK®

DENSICHEK® 1

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 2

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 3

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 4

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 5

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 6

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 7

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

VITEK®

DENSICHEK® 8

Expiration Date:

Recorded Value:

Lot #:

Expiration Date:

Recorded Value:

Expiration Date:

Attachment 1 to VITEK® 2 Systems Preventive Maintenance Procedure (P/N 049294-02-en) (2020-04)

59. Test Audible alarm of the VITEK® 2 System. (PM Section 2.60)

60. View, print, acknowledge, and clear alarms. (PM Section 2.61)

61. If installed, verify OBSERVA® printing and communications. (PM Section 2.62) Check if this step is N/A.

62. If installed, verify BCI is functional. (PM Section 2.63) Check if this step is N/A.

63. Perform a Full System Image or Full System Backup on the VITEK® 2 PC. (PM Section 2.64) Check if this step is N/A.

64. If installed, perform a Full System back up on the OBSERVA® Computer. Check if this step is N/A. (PM

Section 2.65)

65. Review PM with customer.

66. Process test card with customer.

67. Complete the PM certificate.

FSE Name FSE Signature

Notes: