How to Perform a PM

Background

Our instruments may not require calibration, but as errors do happen, we must occasionally perform a preventative maintenance (PM) check on customer’s instruments. This process is very similar to our installation process, and as such you will need an appropriate IQOQ and PQ kits for the instrument to be PM’ed either with you or on site with the customer. It is always suggested to carry a backup kit with you on site in the event the customer cannot locate their kits.

In addition, it is recommended to have the customer locate the original software flash drive for the instrument to be PM’ed, as there are questions on the IQ that ask for this to be present.

Please consult the following lists to ensure all necessary materials are present for the beginning of a PM.

Materials Needed for NC-200 PM

  • NC-200 Software Flash Drive for instrument to be PM’ed
  • NC-200 IQOQ Kit (Cat no. 912-0010)
  • NC-200 PQ Kit (Cat no. 912-0014)
  • Via-1 Cassettes (Cat no. 941-0012)
  • NC-200 Via-2 PQ Kit (Cat no. 974-0005) (if purchased)
  • Via-2 Cassettes (Cat no. 941-0024) (If purchased)

Materials Needed for NC-250 PM

  • NC-250 Software Flash Drive for instrument to be PM’ed
  • NC-250 IQOQ Test Kit (Cat no. 912-0012)
  • NC-250 PQ Kit (Cat no. 974-0004)
  • A2 Slides (Cat no. 942-0001)
  • A8 Slides (Cat no. 942-0003)

Materials Needed for NC-3000 PM

  • NC-3000 Software Flash Drive for instrument to be PM’ed
  • NC-3000 OQ Test Kit 1 (Cat no. 912-3001)
  • NC-3000 Slide PQ Kit (Cat no. 974-0003)
  • A2 Slides (Cat no. 942-0001)
  • A8 Slides (Cat no. 942-0003)
  • Via-1 Cassettes (Cat no. 941-0012)
  • NC-3000 Via-1 PQ Kit (Cat no. 974-0002) (If purchased)

Materials Needed for NC-202 PM

  • NC-202 Software Flash Drive for instrument to be PM’ed
  • NC-202 IQOQ Kit (Cat no. 912-2021)
  • NC-202 PQ Kit (Cat no. 912-2022)
  • Via-2 Cassettes (Cat no. 941-0024)

How Perform a PM for NC-200, NC-250, and NC-3000

  • Upon arrival please ensure all materials needed are present by consulting the lists provided above.
  • Check the exterior of the instrument for the following, the serial number of the instrument is present and matches the serial number listed on the software flash drive, the CE and WEEE symbols are present, five rubber feet are present (or four for the NC-3000 and NC-250), and that the instrument is free from significant and deep marks or scratches (penetrating the outside of the instrument)
  • Remove the IQ and OQ paperwork from the IQOQ Kit, setting aside the OQ paperwork for the time being and placing the IQ paperwork in front of you
  • Note the orange light on the instrument to the customer prior to opening the software
  • Open the instrument software and note the green light to the customer
  • Open the Help > About window to access the Serial Number, software and firmware versions.
    • **If the instrument software is not the most current version, offer to upgrade the customers software prior to continuing with the installation**
  • If all information is up to date, or the customer does not wish to upgrade software, proceed to copy down the serial number, software and firmware versions onto the IQ Checklist.
  • Have the customer validate these numbers to ensure they are copied correctly
  • Check the Tools>Options>PDF Reports menu to ensure that the boxes “Save” and “All Users” are checked, if the customer wishes to leave these unchecked please ensure you Create a PDF Report for each test performed.
  • Proceed through the checklist until reaching the software installation section, ensuring to place only an X within the boundaries of the box on the checklist.
  • IF a software upgrade was performed, you may check the boxes on this section, IF NO SOFTWARE UPGRADE WAS PERFORMED please ask the customer if they are comfortable with you N/A’ing this section of the IQ. 
    • **IF THIS SECTION IS N/A’ed, please make a note explaining why with your initials and the date on both this section, and in the final summary section**
  • Continue to the IQ Test section and select the IQ Test from the select protocol menu as shown below
  • Name the sample “IQ Test” and set the Operator Name to “Vendor”
  • Remove the two Empty IQ Test Cassettes from the IQ Kit and press run on the instrument or software
  • Follow the on screen prompts and remove the final test cassette when the test concludes
    • **If the customer did not wish to automatically generate PDF Reports, create a PDF report of the OQ test at this point by going to Tools > Create PDF Report**
  • Finish the IQ Checklist with a signature from both yourself and the customer
  • Set aside the IQ Paperwork and place the OQ paperwork in front of you
  • Open the Help > About window to access the Serial Number, software and firmware versions.
  • Proceed to copy down the serial number, software and firmware versions onto the OQ Checklist.
  • Copy down the Lot Number and Expiration dates of any materials to be used in the OQ Test, this includes the Kit, Beads, Cassettes and/or Slides.
  • Have the customer validate these numbers to ensure they are copied correctly
  • Proceed through the checklist until reaching the OQ Test
  • Select the OQ Test from the select protocol menu as shown below
  • Name the sample “OQ Test” and set the Operator Name to “Vendor”
  • Remove the vial of OQ Beads from the IQOQ kit as well as a Via-1 Cassette
    • **For the NC-250 no cassette is needed and an A2 slide will be used instead**
    • **For the NC-3000 you will need an A2 Slide in addition to a Via-1 Cassette**
  • Press Run on the instrument and follow the on screen prompts to insert your slide or cassette loaded with OQ Beads into the instrument
    • **If the customer did not wish to automatically generate PDF Reports, create a PDF report of the IQ test at this point by going to Tools > Create PDF Report**
  • Finish the OQ Checklist with a signature from both yourself and the customer
  • Set aside the OQ Paperwork and remove the PQ paperwork from its box
  • Open the Help > About window to access the Serial Number, software and firmware versions.
  • Proceed to copy down the serial number, software and firmware versions onto the PQ Checklist.
  • Copy down the Lot Number and Expiration dates of any materials to be used in the OQ Test, this includes the Kit, Beads, Cassettes and/or Slides.
  • Have the customer validate these numbers to ensure they are copied correctly
  • Ask if the customer would like to perform the PQ or has anyone in their lab who requires training who they wish to perform the following steps
    • **If no one is available to perform the PQ, perform these steps yourself**
  • Select the Zero Count from the select protocol menu as shown below
    • **For NC-200 only**
  • Name the sample “Zero Count” and set the Operator Name to “Vendor”
    • **If the customer did not wish to automatically generate PDF Reports, create a PDF report of the Zero Count at this point by going to Tools > Create PDF Report**
  • Remove the vial of PQ Beads from the PQ kit as well as the appropriate sample media
    • **For the NC-250 no cassette is needed and an A8 slide will be used instead**
    • **For the NC-3000 you will need A8 Slides in addition to a Via-1 Cassette IF the customer purchased the Via-1 PQ Kit**
  • Change the protocol to the “Viability and Cell Count” Assay that is appropriate for the PQ you are performing and for the sample media being used
  • Set the sample name to “Beads 1”
  • Mix your beads well by shaking the vial for several seconds and load your cassette or slide
    • **For slide based PQs you may load all 8 chambers on the A8 prior to counting**
  • Record the data and repeat the previous steps until you have 5 counts in total, and then repeat the previous steps for beads 2 and 3
    • **For slide based PQs you do not need to re run the samples and may simply use the data from the multiple chambers loaded**
  • Fill in the PQ paperwork with acceptable ranges and CVs from the CoA included in the PQ Kit
  • Export the data to Microsoft excel as shown below
  • Calculate the Average and CV for each Bead Test and record on the PQ Checklist
    • **If a failure occurs, find a value that is an apparent outlier remove it from your calculations to see if it causes a pass**
    • **If removal of a data point causes a pass, make a note on the PQ paperwork that this data point was determined to be an obvious outlier and per rules of test was discarded. Please then initial and date next to this note**
  • Using these ranges and CVs, determine if your Beads tests pass or fail
  • Continue through the PQ paperwork and finish the PQ Checklist with a signature from both yourself and the customer
  • Proceed to print the PDF reports generated previously as well as the excel data sheet
  • Finish the PM with signatures from yourself and the customer on each of these printed sheets
  • Prior to leaving, ensure to have the customer scan and send you the IQOQPQ paperwork for your records

How Perform a PM for NC-202

  • Upon arrival please ensure all materials needed are present by consulting the lists provided above.
  • Check the exterior of the instrument for the following, the serial number of the instrument is present and matches the serial number listed on the software flash drive, the CE and WEEE symbols are present, five rubber feet are present and that the instrument is free from significant and deep marks or scratches (penetrating the outside of the instrument)
  • Remove the IQOQ paperwork from the IQOQ Kit
  • Note the orange light on the instrument to the customer prior to opening the software
  • Open the instrument software and note the green light to the customer
  • Open the Help > About window to access the Serial Number, software and firmware versions.
    • **If the instrument software is not the most current version, offer to upgrade the customers software prior to continuing with the installation**
  • If all information is up to date, or the customer does not wish to upgrade software, proceed to copy down the serial number, software and firmware versions onto the IQ Checklist.
  • Copy down the Lot Number and Expiration dates of any materials to be used in the IQ and OQ Tests, this includes the Kit, Beads, and Cassettes.
  • Have the customer validate these numbers to ensure they are copied correctly
  • Continue to the IQ Test section and select the NC-202 IQ/OQ Test from the select protocol menu as shown below
  • Name the sample “IQ Test” and set the Operator Name to “Vendor”
  • Press run on the instrument or the software and when prompted on screen select “IQ Test”
  • Follow on screen prompts until the test concludes and mark down if the test has passed or failed with an X inside the box
  • Generate a PDF Report of the IQ by selecting it in the data list at the bottom of the window and pressing the PDF button.
  • Continue to the OQ Test section and select the NC-202 IQ/OQ Test from the select protocol menu as shown below
  • Name the sample “OQ Test” and set the Operator Name to “Vendor”
  • Press run on the instrument or the software and when prompted on screen select “OQ Test”
  • Remove the OQ Beads from the IQOQ Kit and shake well
  • Load a Via-2 Cassette with your OQ Bead Solution
  • Follow on screen prompts until the test concludes and mark down if the test has passed or failed with an X inside the box
  • Generate a PDF Report of the OQ by selecting it in the data list at the bottom of the window and pressing the PDF button.
  • Finish the IQOQ Paperwork with a signature from yourself and the customer
  • Remove the PQ paperwork from the PQ Kit
  • Open the Help > About window to access the Serial Number, software and firmware versions.
  • Proceed to copy down the serial number, software and firmware versions onto the PQ Checklist.
  • Copy down the Lot Number and Expiration dates of any materials to be used in the PQ Test, this includes the Kit, Beads, and Cassettes.
  • Have the customer validate these numbers to ensure they are copied correctly
  • Ask if the customer would like to perform the PQ or has anyone in their lab who requires training who they wish to perform the following steps
    • **If no one is available to perform the PQ, perform these steps yourself**
  • Select the NC-202 IQ/OQ Test from the select protocol menu as shown below
  • Name the sample “Zero Count” and set the Operator Name to “Vendor”
  • Press run on the instrument or the software and when prompted select “Zero Count”
  • Generate a PDF Report of the Zero Count by selecting it in the data list at the bottom of the window and pressing the PDF button.
  • Remove the vial of PQ Beads from the PQ kit as well as the appropriate sample media
  • Change the protocol to the “Count & Viability” Assay 
  • Set the sample name to “Beads Low”
  • Mix your beads well by shaking the vial well for several seconds and load your cassette or slide
  • Record the data and repeat the previous steps until you have 5 counts in total, and then repeat the previous steps for beads Medium and High
  • Fill in the PQ paperwork with acceptable ranges and CVs from the CoA included in the PQ Kit
  • Export the data to Microsoft excel by shift+clicking your data files at the bottom of the screen to highlight multiple counts at once and then selecting the copy to clipboard option as shown below
  • Calculate the Average and CV for each Bead Test and record on the PQ Checklist
    • **If a failure occurs, find a value that is an apparent outlier remove it from your calculations to see if it causes a pass**
    • **If removal of a data point causes a pass, make a note on the PQ paperwork that this data point was determined to be an obvious outlier and per rules of test was discarded. Please then initial and date next to this note**
  • Using these ranges and CVs, determine if your Beads tests pass or fail
  • Continue through the PQ paperwork and finish the PQ Checklist with a signature from both yourself and the customer
  • Proceed to print the PDF reports generated previously as well as the excel data sheet
  • Finish the PM with signatures from yourself and the customer on each of these printed sheets
  • Prior to leaving, ensure to have the customer scan and send you the IQOQPQ paperwork for your records
Last updated byAnonymous