Equipment Preventive Maintenance
H.5. ACL 7000 Analyzer Preventive Maintenance
Author: Penny Stevens / Document Number: / Equ21-03Effective (or Post) Date: / 13-Jan-09
Review History / Date of last review: / 27 July 2010
Reviewed by: / Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE..
Copy _____ of ___ Effective Date:
HEMATOLOGY SECTION
H. EQUIPMENT PREVENTIVE MAINTENANCE
H.5. ACL 7000 ANALYZER PREVENTIVE MAINTENANCE
H.5.1. PRINCIPLE:
1. The ACL System is a precision coagulation instrument. In order to maintain the system, it is recommended that a trained operator carry out the following operations.
2. Daily, weekly, and periodic schedules of all necessary levels of maintenance are also included.
3. Careful observance of the preventive maintenance schedules and proper recording of data on the worksheet provides both user and service technician with vital information necessary to obtain service for the ACL 7000 System.
4. Any problems that cannot be corrected by repeating the procedure, or other minor troubleshooting, should be directed to the Hematology Supervisor or NCOIC.
H.5.2. PROCEDURE:
1. DAILY SCHEDULE:
1.1. Instrument Status: For best results, the instrument should be left permanently ON. The complex electronic circuitry is most reliable if the number of switches “Off” and “ON” is reduced to a minimum. The standby condition guarantees minimum power consumption and maximum readiness for operation at any time.
1.2. Clear Loadlist: The loadlist is a working document. It is not permanent memory. Clear the loadlist at the beginning of first shift through the following keys:
Select “PROG” to display the utility menu and use the “” and “¯” keys to select the “LOADLIST” menu and “” to clear and then press ENTER. Press “Ü” to return to the main menu.
1.3. Priming Procedure:
1.3.1. At the beginning of first shift, perform a priming procedure to ensure the complete removal of all sample or reagent residues.
1.3.2. Select “PROG” to display the utility menu and use the “” and “¯” keys to select the “DIAGNOSTICS” menu and “PRIMING” mode and then press ENTER.
1.3.3. The “Please Wait” display is presented during the priming cycle, while the dispenser system flushes out both the sample and reagent needles.
1.3.4. Check that during priming the number of bubbles in the dilutor chambers is reduced to a minimum. If it is necessary, pinch the chamber outlet tubes while the piston is descending, releasing them before the piston reaches the bottom dead center.
1.3.5 At the end of the priming cycle, press “PROG” to return the instrument to the “READY” menu.
1.4. Cleaning the exposed surfaces of the instrument: Wipe down all exposed surfaces. Clean the inside of the auto-sampler and the rotor compartment using gauze soaked with 10% bleach solution, and then rinse with distilled water.
1.5. Reagent vessels: Clean the reagent vessels with distilled water and dry with gauze.
1.6. Rotors: Discard any fully used rotors. A partially used rotor may be left in the rotor housing, if you intend to use it during the day. Otherwise, discard the rotor to avoid possible contamination problems. Do not return a partially used rotor to the rotor preheater.
1.7. Reference Emulsion: The minimum volume is 1.5 to 2 cm of liquid in the container. Replace the reagent and perform the priming procedure if the volume is below the minimum. (See 3. Periodic Schedule, 3.2 Replacing the Reference Emulsion Solution.)
1.8. After all daily preventive maintenance has been done, document actions taken and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
2. WEEKLY SCHEDULE:
2.1. Waste Line Cleaning Procedure: To avoid possible blockages in the waste line due to a clot formation, follow the steps below:
2.1.1. Use the following materials:
2.1.1.1. Plastic syringe (20-cc capacity)
2.1.2.2. 10-cm PVC tube
2.1.3.2. 20mL of distilled water
2.1.2. Fit the PVC tube on the end of the syringe. Fill the syringe with distilled water.
2.1.3. From the main program, select “PROGRAM, DIAGNOSTICS, AND NEEDLE POSITION” option, and then press ENTER. Open the rotor housing cover and press the “” key to continue. The needle arm will position above the rotor holder. Clean the needles with an alcohol pad while they are positioned above the rotor holder.
2.1.4. Remove the rinse reservoir and dump the liquid into the biohazard waste. Rinse the reservoir with distilled water.
2.1.5 Insert the PCV tube into the waste line of the ACL. Carefully inject the distilled water into the waste line and check that the water flows out from the external waste line of the instrument.
2.1.6. Repeat the procedure at least two times.
2.1.7. Replace the rinse reservoir and return the instrument to the ready state by pressing “Ü”.
2.1.8. Record action and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
2.2. Clean optical path:
2.2.1. Clean the halogen lamp optic sensor with a cotton tip applicator slightly moistened with reagent grade water. Dry the optic sensor with a clean dry cotton tip applicator.
2.2.2. Moisten another cotton tip applicator and clean the 20 holes of the rotor holder. Dry with a clean dry applicator.
2.3 Needle cleaning procedure: The following cleaning procedure will guarantee the removal of protein and other deposits from the inside and outside of the needles.
2.3.1. Materials and preparation:
2.3.1.1. 4 x 0.5 mL sample cups
2.3.1.2. 3 maintenance reagent reservoirs. Do not use the daily reagent vessels for maintenance.
2.3.1.3. 20 mL distilled water
2.3.1.4. 20 µL concentrated HCL. Combine the HCL and 20 mL’s of distilled water into a working solution.
2.3.2. Load the Sample Tray as follows:
2.3.2.1. Position POOL – 0.5 mL HCL solution
2.3.2.2. Position 1 - 0.5 mL of Factor Diluent
2.3.2.3. Position 2 - 0.5 mL of HCL solution
2.3.2.4. Position 3 - 0.5 mL of Factor Diluent
2.3.3. Load reagent vessels as follows:
2.3.3.1. Reagent 1 - 10 mL of Factor Diluent
2.3.3.2. Reagent 2 - 10 mL of HCL solution
2.3.3.3. Reagent 3 - 10 mL of Factor Diluent
2.3.4. Insert a clean rotor into chamber. Press PROG to return to the run menu.
2.3.5. Select the “Double Tests” option for the cleaning cycle and press ENTER. Then select PT-FIB/APTT cycle, and press ENTER.
2.3.6. Select the “¯” key to start analysis.
2.3.7. Select a loadlist and press ENTER.
2.3.8 Program the loadlist using any number or letter for positions 1, 2 and 3. Press COMMANDS to start processing.
2.3.9. Ensure that fluid is aspirated and processed through the needles. The purpose of this step is to clean the needles through HCL solution aspiration.
2.3.10. A warning will appear at the end of the cleaning process. Ignore this message and press the “¯” to continue.
2.3.11. Remove the rotor from the rotor holder and discard. Remove and discard the sample cups. Remove and clean the reagents reservoirs with distilled water.
2.3.12. Prime the instrument as described previously in this SOP, section 1.4.
2.3.13. Record action and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
2.4. Coagulation Channels readings: Ensure that the optics have been cleaned before proceeding with the readings.
2.4.1. Using a 200µL pipette, prepare a rotor as follows:
2.4.1.1. Dispense 200µL of Reference Solution into cuvette 20. Use the solution on the analyzer. This ensures that the voltage for the current bottle of reagent is with the required limits.
2.4.1.2. Dispense 200µL of Reagent Grade water into cuvette 6
2.4.2. Place the loaded rotor on the instrument. Align the laser between cuvette position 6 and 7.
2.4.3. From the “PROG, select DIAGNOSTICS, and SERVICE, and then press ENTER. Access the “SERVICE” program, using the “” and “¯” keys and then press ENTER.
2.4.4. Enter the Password code 00810.
2.4.5. Move the cursor to the “AD Conv Test” option, and press ENTER. Access the “COAG CHANNEL” option using the “” and “¯” keys, and then press ENTER.
2.4.6. Record the “COAG CHANNEL” reading into the ACL 7000 Analyzer Preventive Maintenance Worksheet.
2.4.7. The reference range for this channel should be 0 to 0.01 V. The results displayed will fluctuate. Occasional fluctuation outside of the reference range is acceptable. However, if they remain consistently outside of the reference range, notify the Hematology Supervisor or NCOIC immediately. Corrective action must be taken.
2.4.8. Move the cursor to the “EXIT” option and press ENTER. The instrument will return to the “SERVICE” program.
2.4.9 From the “SERVICE” program, access the “ACQ. ADJUSTMENT” option using the “” and “¯” keys and then press ENTER.
2.4.10. Record the coagulometric channels into the ACL 7000 Analyzer Preventive Maintenance Worksheet.
2.4.11. The reference range for the channels should be 2.4 to 3.0 V. If results are outside of the reference range, notify the Hematology Supervisor or NCOIC immediately. The company must be contacted for the adjustment of the coagulometric channels.
2.4.12. Move the cursor to the “EXIT” option and press ENTER. This will reset the instrument.
2.5. Change the air filter: Remove the air filter from the left side of the instrument and replace it with a clean one. If you are unable to locate the air filter housing, see page 5.7 of the operator’s manual for the location diagram. Clean the filter with water and allow it to air dry.
2.6. Empty Waste: Empty the Waste Liquid Container on a weekly basis. Verify that the waste flows freely into the container.
2.7. Check/Purge the DMS (Database Management System): This is the permanent memory storage for all programmed specimen results. The DMS storage capacity is 300 entries. Once this storage capacity has been reached, the system will not permit further testing. Therefore, the DMS must be purged before it reaches 300 entries. Purge as follows:
Select PROGRAM and DMS. At the top right of the screen the total number of samples will be displayed. If this number is greater than 200, purge the memory. Press the DEL key, the “¯” key and then press ENTER. Confirm deletion by pressing enter again.
3. PERIODIC SCHEDULE:
3.1. Changing the paper: To change the paper on the ACL 7000 follow the steps below:
3.1.1. Pull the printer cover forward from the top.
3.1.2. Remove the old roll and tear off the paper (if any) which passes into the printer mechanism.
3.1.3. Press the gray button (lower right of the printer) to eject any remaining paper.
3.1.4. Cut the leading edge of the new paper roll and insert into the upper printer slot pushing it forward until it comes in contact with the paper advance roller.
3.1.5. Press the gray button again until the paper exits from the lower slot. Place the paper roll into this housing.
3.1.6. When the paper appears at the top of the cover, stop the paper advance and close the cover by pulling lightly upwards on the paper.
3.1.7. Record action and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
3.2. Replacing the Reference Emulsion Solution:
3.2.1. Check that there is at least 1.5 to 2 cm of liquid in the container.
3.2.2. Replace with a new bottle of Reference Solution, if necessary.
3.2.3. Carry out the priming procedure as indicated above in this SOP.
3.2.4. Record action and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
3.3. Needle adjustment procedure:
3.3.1. From the main program, select “PROGRAM, DIAGNOSTICS, and select NEEDLES POSITION”.
3.3.2. Open the rotor cover.
3.3.3. Loosen the orange knob on the needle arm and lift or insert the needle block leaving the upper surface higher than the arm upper surface.
3.3.4. Insert the special tool “needle position shim” into the rotor holder position number 1 with side A facing up.
3.3.5. Press “” to select the “UP/DOWN” option to lower the arm.
3.3.6. Adjust the height of the needle block so that the needles touch the upper surface of the tool while ensuring that the two needles match the two references dots present on the tool surface.
3.3.7. Block the needles by screwing the orange arm knob. Ensure that the position is not changed after they are blocked.
3.3.8. Press “” to select the “UP/DOWN” option. This will lower the arm into cuvette position 1. Verify that the needles are entering into the rotor holes without friction.
3.3.9. Press “” to raise the arm.
3.3.10. Select ““¯” key to move the rotor through cuvette positions 6, 11 and 16. If during the execution of this procedure friction occurs, insert the tool again and repeat the entire procedure using a new rotor.
3.3.11. Select “PROG” option to exit and return to the main menu.
3.3.12. Record action and date on the ACL 7000 Analyzer Preventive Maintenance Worksheet.
3.4 Prime Flow Verification
3.4.1. Remove the probe from the assembly: Loosen the orange knob on the needle arm and lift the needle block out of the assembly.
3.4.2. Point the probes toward a small cup placed to the left of the probe assembly arm. The cup should be small but large enough to hold fluid that will be discharged during the priming steps.
3.4.3. Prime the instrument: Select “PROG” to display the utility menu and use the “” and “¯” keys to select the “DIAGNOSTICS” menu and “PRIMING” mode and then press ENTER.
3.4.4. The arm assembly will automatically swing left and right before priming begins. Stay clear and do not bump the arm during this process or the prime will abort due to a probe error.
3.4.5. The prime cycle will begin with a fast prime. Observe the fluid that is discharged from both probes. The flow should be relatively straight. If it is diagonal from one or both probes, the probe should be cleaned until it is straight or replaced. Observe the volume that is discharged from both probes. It should be relatively the same volume from both. If one probe discharges significantly more or less fluid than the other, the probe should be cleaned until they are the same or replaced.
3.4.6. The prime cycle will finish with a slow prime cycle. Fluid will collect and drip from the end of the probe. Observe the size and rate of fall for both probes. They should be relatively the same. If one produces significantly larger/smaller or faster/slower drops, the probe should be cleaned until they are the same or replaced.