Sysmex CA600 Coagulation Analyzer

Standard Operating Procedures^[1]

a. Running Maintenance

1. Turn off analyzer.

   • The power switch is on the left side of the analyzer. It is always good practice to turn the analyzer off while performing maintenance.

2. Open the light shield.

   • This opens upwards and will sit on the top of the analyzer.
   • Make sure it is sitting flat to avoid it closing while you are working in the analyzer.

3. Check/Replace distilled water located on the right side of the analyzer.

   • When removing the tubing from the container place it on paper towel to avoid contamination of the distilled water.
   • Do not touch the outside of the tubing when putting it back into the container.
   • Gently pour the old, distilled water down the “dirty sink” and fill the container about 1/3 to 1/2 full.
   • Wipe the edge of the container with paper towel to avoid dripping when transporting back to the analyzer.
   • Make sure the cap is hand tightened, only

4. Check/Empty the waste container located on the right side of the analyzer.

   • This is waste, so place the tubing in a container to avoid contaminating the bench area.
   • Gently pour the waste down the “dirty sink” while running the water.
   • Wipe the edge of the container with paper towel to avoid dripping when transporting back to the analyzer.
   • Make sure the cap is hand tightened, only.

5. Check/Empty the reaction tube trash box located on the right side of the analyzer.

   • Gently remove the black box and empty the reaction tubes into an appropriate waste container.
   • Do not discard the cardboard insert, only the reaction tubes inside.

6. Check/Replenish the reaction tubes in the blocks, if needed.

   • Make sure there are enough reaction tubes on board for testing.
   • There are always two filled back-up blocks or reaction tubes ready to go.

7. Remove condensation from the reagent rack using gauze or kim-wipe/towel.

   • Remove the reagent rack and wipe off any condensation present on the cooling section, below the rack (left side). Insert paper towel/Kim wipe into the four holes on the left side of the reagent rack and wipe off any condensation.
   • Put the reagent rack back in place.

8. Load the buffer into position. Pour buffer into the 10mL push vial and place in the well labelled “B”.

   • This cup is pre-labelled, buffer, and is located on the right end of the reagent block.

9. Load the CA Clean I into position. Pour Clean I into a 10mL push vial, and place in the well labelled “I”.

   • The cup is pre-labelled, Clean I, and is located on the right side of the reagent block.

10. Load the CA Clean II into position.

    • This is stored in the refrigerator.
    • Pour Clean II into a 4mL cup, and place in the well labelled “II”.
    • Make sure it is labelled CLEAN II and is located on the right side of the reagent block.

11. Turn on the analyzer.

    • The power switch is on the left side of the analyzer.

12. Check temperatures for the cooler, detector, probe and room.

    • Press “Sysmex” on the top left of the main screen.
    • Press “temperature”. Make sure all are within acceptable limits.
    • Refer to the maintenance check list for these ranges.

13. Check/Replace thermal printer paper as needed.

    • Press “Sysmex” on the top left of the main screen.
    • Press “Paper feed” a couple of times to allow some paper to come out.
    • Only Replace if a red line is seen on the side of the printer paper, as it is coming out.

14. Document the maintenance on the monthly maintenance checklist.

    • Note: this is checklist covering all maintenance.
    • Only check off the maintenance you did following this procedure.
    • Check off the maintenance under the appropriate date and initial the bottom where indicated.
    • Only one student’s initial per group is required.
    • Note: Some maintenance is only performed by the instructors. (i.e. wiping probe with alcohol)

b. Running QC

Two levels of controls are run daily, or each shift depending on lab protocol. All controls must be within reference limits before patients are reported. Further action will need to be taken in the event the controls are out.

• – Ci-Trol 1 (QC1) – Normal Control – Reconstituted with 1mL of Distilled Water
• – Ci-Trol 2 (QC2) – Abnormal Control – Reconstituted with 1mL of Distilled Water

1. Remove the controls from the fridge and check the lot number and expiry date.

   • Ensure they match the information posted on the instrument.
   • Document the information on your worksheet.

2. Label two 2mL cups with control information along with the date and time. (if not already done)

   • Once controls are placed in the 2 mL labelled cup, they can be stored in the fridge for up 24 hours between runs.
   • Once you finish with the controls parafilm them and place them back in the fridge.
   • If controls are still on the analyzer when you run your controls, always check the labelled information before using them.
   • Label one cup as QC01. This is the normal control. Label the second cup as QC02. This is the abnormal control.
   • Write the date and time on each cup.
   • The controls are good for 24-hours, so this information is important.
   • Make sure the cups are clearly labelled and legible.

1. Place the controls in the sample rack.

   • Position 1 is for QC01 and Position 2 is for QC02.

2. On the main screen press “ID No Entry” to open a keypad to the right for typing the QC #.

   • If you are the first group to enter QC or patients, you will start at rack 1, position 1.
   • Any subsequent orders will go to the next available rack #, so rack 2, position 1.

3. Type QC01 and then choose the tests requested.

   • You must say QC01 to properly order the control.
   • Just above the ID No. are the list of tests to choose from.
   • Press the test to order them.
   • Take note that each test is numbered and represents the numbering sequence to the right.
   • If you order the wrong test, you can press the test again and it will be deleted.
   • You can also use arrow keys to move between rack positions, if needed.

4. Repeat step 5 to enter QC02. Follow the same instructions.

5. Open the sample drawer at the bottom and gently load the samples rack in position.

   • The slotted areas on the rack are facing out towards the technologist.
   • The slit in the bottom of the rack is on the left side and is hooked onto the small metal bar on the left side of the drawer.
   • Make sure the rack is flat and not tilted.
   • Be careful not to spill any samples when loading the rack.

6. Once the rack is in place gently shut the sample drawer.

   • Make sure the drawer is closed completely or the analyzer will not run, and an alarm will sound.

7. Make sure all tests have been ordered.

   • The tests will be ordered before you load the rack to make sure they are in the proper positions.
   • Refer to ordering tests instructions.

8. Press start on the top right-hand side of the screen to begin analysis.

   • When the analyzer begins it will indicate “Analyzing” at the top of the screen.
   • Below that you will see “Replace Rack? No!”.
   • This means you cannot open the sample drawer or place another rack on the analyzer.
   • Once analysis is close to completion, or completed, the sign will change to “Replace Rack? YES!”
   • This means you can open the sample drawer, remove the rack, and load another rack.

9. NOTE

• • At no time during the testing can you lift the light shield. If you do, then all tests in process will be stopped and will need to reload those samples.
  • Always make sure “Display rack Yes is indicated before you open the sampler drawer, or all tests in process will be stopped!

c. Running Patients

1. Confirm the maintenance has been completed before analyzing patients.

   • Always check the maintenance log to make sure all daily maintenance has been completed.
   • If maintenance is not done, you will need to complete it before continuing.

2. Confirm that the appropriate reagents are on board and enough for testing.

   • Although it is done with maintenance, it is still good idea to make sure you check reagents before starting.

3. Document the patient information on your worksheet.

   • Always document the patient information on the worksheet before loading the sample and ordering tests.
   • Use the full patient’s name and 2 unique identifiers.
   • Never work with a worksheet with no patient information!

4. Label a 2mL cup with patient information.

   • Label the cup with the patient’s full name and 2 unique identifiers.
   • Make sure the cups are clearly labelled and legible.

5. Place patient cup in the sample rack.

   • Always start at position 1, and so on. In the main menu, press ID No. Entry.
   • This will open a numerical keypad to enter the patients ID

6. The keypad cannot generate letters so you will have to use the ID number (HCN, MRN or accession #).

7. Order the tests requested.

   • Just above the ID No. are the list of tests to choose from.
   • Press the test to order them.
   • Take note that each test is numbered and represents the numbering sequence to the right.
   • If you order the wrong test, you can press the test again and it will be deleted.
   • You can also use arrow keys to move between rack positions, if needed.

8. Open the sample drawer at the bottom and gently load the sample rack in position.

   • The slotted areas on the rack are facing out towards the technologist.
   • The slit in the bottom of the rack is on the left side and is hooked onto the small metal bar on the left side of the drawer.
   • Make sure the rack is flat and not tilted.
   • Be careful not to spill any samples when loading the rack.

9. Once the rack is in place gently shut the sample drawer.

   • Make sure the drawer is closed completely of the analyzer will not go, and an alarm will sound.

10. Press start on the top right-hand side of the screen to begin analysis.

    • When the analyzer begins it will indicate “Analyzing” at the top of the screen.
    • Below that you will see “Replace Rack? No!”.
    • This means you cannot open the sample drawer or place another rack on the analyzer. Once analysis is close to completion, or completed, the sign will change to “Replace Rack? YES!”
    • This means you can open the sample drawer, remove the rack, and load another rack.

11. Remove the thermal printout and write the patients full name and second unique identifier on the paper.

    • Attach to your worksheet. It is important to write the patients name on the printout.
    • Confirm the patient ID to make sure you have the correct patient.
    • Staple the results to the worksheet, before passing them in.

12. Properly transcribe the patients results onto the worksheet provided.