CA-1500 Technical Troubleshooting Guide ver 2.0 March 2013

CONTENTS INTRODUCTION ... 3 DAILY MAINTENANCE ... 4 Cleaning the sample and reagent probes ... 4 Changing the rinse (distilled water) ... 4 Discarding the used reaction tubes. ... 5 Discarding the waste. ... 5 Removing condensation from the reagent trays. ... 6 Checking and discarding trap chamber fluid. ... 6 Adjusting the 2.2 kg/cm2 pressure ... 6 Adjusting the 1.0 kg/cm2 pressure ... 7 Adjusting the 500 – 530mmHg vacuum ... 7 WEEKLY MAINTENANCE. ... 8 Priming the hydraulic line with rinse solution... 8 Clean the instrument exterior ... 8 Clean the instrument interior ... 8 MONTHLY MAINTENANCE... 9 Decontaminate hydraulic lines. ... 9 Calibrating the detectors using CA-Cal S... 10 Checking the LED calibration history. ... 12 AS REQUIRED MAINTENANCE... 14 Replenishing reaction tubes. ... 14 Chromogenic lamp replacement procedure ... 14 Replacing the cap piercer probe ... 20 Removal of the cap piercer probe. ... 21 Installing a new Cap Piercer Probe. ... 22 Resetting the piercer cycle counter... 23 Checking and adjusting the mechanical positions of the sample probe... 24 Adjusting the mechanical positions of the reagent probe ... 38 TROUBLESHOOTING ... 43 Vacuum Errors. ... 43 Vacuum error occurs all the time. ... 43 Vacuum error occurs when the reagent/sample probe is being rinsed ... 43 Vacuum error is intermittent. ... 43 Temperature Errors ... 44 Document Ref:SUKBMS-13-259

Page | 1

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Cooler error (Temperature High) ... 44 Reagent probe temperature error. ... 44 Other common errors ... 45 High PT’s.(All other tests are OK). ... 45 High APTT’s ... 45 Fluid on top of caps of sample tubes. ... 46 probe crash (Rinse). ... 46

Document Ref:SUKBMS-13-259

Page | 2

Version:2.0

Date:03/12/2013

Classification:Company Confidential

INTRODUCTION This manual is designed to help the Operator of the CA-1500 Coagulation Analyser to carry out basic repairs and adjustments to their analyser, in conjunction with the Coagulation Analyser Tool Kit supplied by Sysmex UK Ltd. A list of the contents of the Coagulation Analyser Tool Kit is listed below.

981-0481-8

Piercer for CA-15H

1

442-5055-4

Tube Polyurethane 1.8 x 3.4

1M

442-5287-4

Silicone Tubing 1/8 x ¼ F7398

1M

226-3227-4

Lamp Halogen JCR/M (6V10W) H20-3L

1

443-8676-3

Valve Seal (2 Port) WTKV019-12 PVC

1

443-9664-2

Air Valve WTKV-015-1

2

Screwdriver Philips No.1300 #2

1

Torch

1

Tool Box

1

Screwdriver Philips #0

1

Side Cutters

1

Mini Long Nose Pliers

1

Dental Mirror

1

Toothbrush

1

Document Ref:SUKBMS-13-259

Page | 3

Version:2.0

Date:03/12/2013

Classification:Company Confidential

DAILY MAINTENANCE Cleaning the sample and reagent probes Clean the sample probe and reagent probe at the completion of the day’s work or at least every 24 hours. 1. From the main menu screen, press the [rinse probe] key. The rinse probe screen will appear. 2. Set CA CLEAN I to both the reagent holders A2 and E3. 3. Press the [execute] key. The probe cleaning will start; this takes approximately 3 minutes to complete. 4. Press the [return] key. Note: If the outside of the probe is still noticeably dirty after cleaning, dip gauze or lint free tissue in alcohol and wipe off the probe from top to bottom. This procedure is for NON CAP PIERCER analysers ONLY.

NEVER clean the outside of a cap piercer probe unless instructed to do so by SYSMEX (U.K.) Ltd.

Changing the rinse (distilled water) If the rinse solution runs out during an analysis, an error message “replenish rinse solution” will appear and the analysis will be interrupted. A “being interrupted” message will appear. Wait shortly until the interruption process is complete. When the system is ready for replenishing the distilled water, a message will appear. 1. Turning the cap anti-clockwise, open the rinse tank cap that does not have tubing and float switch connected. 2. Fill up the rinse tank with distilled water. 3. Tighten the cap clockwise to close. 4. Make sure the tubing is connected and not kinked. 5. Press the [resume] key.

Document Ref:SUKBMS-13-259

Page | 4

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Discarding the used reaction tubes. The used reaction tubes are automatically thrown in the trash box. At the completion of every 250 samples or at least once every 24 hours, discard the reaction tubes from the trash box and clean it with tap water. 1. While the power is still on and the instrument status is “ready”, pull up the trash box slightly and then draw it out from the left side of the panel. Although a message “ tube trash has not been set” will appear, disregard this. 2. Discard the used reaction tubes. 3. Clean the reaction tube trash box with tap water, and thoroughly wipe off moisture from the reaction tube trash box. 4. Restore the reaction tube trash box.

Discarding the waste. At completion of the day’s analysis, discard the waste fluid that has collected in the waste tank, if provided. The following procedure is carried out with the power on. 1. If the tank becomes full with waste during analysis, an alarm will sound and a conformation screen will appear. Press the [OK] key and wait until the analysis is interrupted. When the system is ready for waste disposal, a message will appear. 2. Open the cap from the waste tank. Turn the cap anti-clockwise and take out the float switch carefully avoiding splashes or drips. 3. Discard the waste fluid. 4. Insert the float into the tank, turn the cap clockwise. 5. Make sure that the tubing is securely connected and is not kinked. 6. Press the {Resume] key.

Caution: The Waste Container and contents should be considered potentially hazardous. Take all the necessary precautions when disposing of the Waste. Dispose of the Waste according to your Laboratory’s policy and existing Hospital, Laboratory and Government Regulations.

Document Ref:SUKBMS-13-259

Page | 5

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Removing condensation from the reagent trays. After completion of the day’s analysis or at least once every 24 hours, check to see if condensation has formed on the reagent trays. Remove any if found. This procedure must be completed with the power OFF; failure to do so may result in electric shock. 1. Turn OFF the power. 2. Open the light shield lid. 3. Pull out the reagent trays. 4. Using a paper towel, remove the condensation from the cooling unit. 5. Reinsert the reaction trays. 6. Close the light shield lid. 7. Turn ON the power.

Checking and discarding trap chamber fluid. After completion of the day’s analysis, check the trap chamber fluid and discard any collected fluid. 1. Turn OFF the power and wait 30 seconds. 2. The trap chamber is located on the right side of the instrument. Turn the trap chamber anti-clockwise and remove it. 3. Discard the fluid and remount the trap chamber. Make sure the float is inside and float direction is correct. 4. Turn ON the power.

Adjusting the 2.2 kg/cm2 pressure 1. Loosen the fixing screw on the 2.2kg/cm2 adjustment knob by turning a screwdriver anti-clockwise while the adjustment knob is held to prevent it from rotating. 2. Adjust the pressure by turning the adjustment knob as you check the current value for the 2.2kg/cm2 pressure on the pressure adjustment screen. The pressure will rise as you turn the adjustment knob clockwise. 3. After adjustment, tighten the fixing screw while taking care not to allow the adjustment knob to rotate. 4. When 2.2kg/cm2 pressure is adjusted, check the 1.0 kg/cm2 pressure and adjust if required.

Document Ref:SUKBMS-13-259

Page | 6

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Adjusting the 1.0 kg/cm2 pressure 1. Pull the 1.0kg/cm2 adjustment knob towards you to unlock. 2. Adjust the pressure by turning the adjustment knob as you check the current value on the pressure adjustment screen. The pressure will; rise as you turn the adjustment knob clockwise. 3. After adjustment, prevent the adjustment knob from turning by pressing it in until it locks.

Adjusting the 500 – 530mmHg vacuum 1. Unlock the locking nut located at the bottom of the adjustment pin on top of the bellows unit, 2. Adjust the vacuum by turning the adjustment screw as you check the current value on the pressure adjustment screen. The vacuum will rise as you turn the adjustment screw clockwise, and decrease when you turn the adjustment screw counterclockwise. 3. After adjustment, prevent the adjustment screw from turning by tightening the lock nut by turning the lock nut in a clockwise direction. SYSMEX (U.K.) Ltd also recommend that the CA-1500 is turned off and back on again once every 24 hours so the analyser can perform a diagnostics Self Check on itself to ensure that the instrument is in good working order.

Document Ref:SUKBMS-13-259

Page | 7

Version:2.0

Date:03/12/2013

Classification:Company Confidential

WEEKLY MAINTENANCE. Priming the hydraulic line with rinse solution. Once a week or if the instrument has not been run for two days. 1. Check that there is sufficient rinse solution in the rinse tank and the waste tank is empty, if it is provided. 2. From the main menu screen, press the [Special Menu] key. The special menu will appear. 3. Press the [Maintain] key. The maintenance sub menu will appear. 4. Press the [Rinse & Prepare] key. The prime and rinse execution screen will appear. 5. Press the [Execute] key. Priming with rinse solution will start. While the priming is taking place, the time remaining will be displayed on the screen. 6. Press the [Return] key. The maintenance sub menu will reappear.

Clean the instrument exterior 1. Turn OFF the power. 2. Using a paper towel that has been moistened with water and a neutral detergent, wipe off the exterior, then wipe again with a soft, dry paper towel. 3. Turn ON the power.

Clean the instrument interior 1. Open the light shield lid. 2. Pull out the reagent trays. 3. Using a paper towel that has been moistened with water and a neutral detergent, wipe over the interior, wipe again with a soft, dry paper towel. Clean the remove reagent trays in the same manner. 4. Reinsert the reagent trays. 5. Close the light shield lid.

Document Ref:SUKBMS-13-259

Page | 8

Version:2.0

Date:03/12/2013

Classification:Company Confidential

MONTHLY MAINTENANCE. Decontaminate hydraulic lines. 1. Remove the float switch sensor from the distilled water keg (under the bench), and turn the float switch sensor upside down. This will stop the analyser from indicating that there is insufficient rinse solution. 2. Enter into the high level software of the CA-1500 by pressing: [Worklist], [ID Number Entry], [C], [9], [-], [0], then [Enter]. 3. Return to Main menu and select: [Special Menu], [Service], [Test Menu], [Drain Liquid], [Action 1] and [Execute].

Warning: Place tissues around the rinse cups as distilled water will be emitted from the rinse cups. 4. When the Execute and Return buttons becomes available, return to the Main menu. 5. Place the float switch sensor into a beaker containing at least 300 ml of 5% hypochlorite solution. Select Special menu, Rinse and prepare, Execute. Perform a rinse and prepare twice, then leave for at least 10 minutes. 6. This will now fill ALL the hydraulic lines and the reservoir with hypochlorite solution. NEVER use household bleach on this analyser. Only use a Laboratory grade hypochlorite. 7. Remove the float switch sensor from the beaker containing the hypochlorite solution, and turn the float switch sensor upside down. This will stop the analyser from indicating that there is insufficient rinse solution. 8. Return to Main menu and select: [Special Menu], [Service], [Test Menu], [Drain Liquid], [Action 1] and [Execute].

Warning: Place tissues around the rinse cups as distilled water will be emitted from the rinse cups. 9. Place the float switch sensor into a beaker containing at least 300 ml of distilled water. Select Special menu, Rinse and prepare, Execute. Perform a rinse and prepare twice. 10. Remove the float switch sensor from the beaker containing the distilled water, and turn the float switch sensor upside down. This will stop the analyser from indicating that there is insufficient rinse solution. Document Ref:SUKBMS-13-259

Page | 9

Version:2.0

Date:03/12/2013

Classification:Company Confidential

11. Return to Main menu and select: [Special Menu], [Service], [Test Menu], [Drain Liquid], [Action 1] and [Execute]. 12. Refit float switch sensor back into the distilled water keg, containing fresh distilled water. 13. Select [Special Menu], [Rinse and Prepare] and [Execute]. Perform a rinse and prepare twice. 14. The analyser is now ready to run samples.

Calibrating the detectors using CA-Cal S IMPORTANT: Before using the CA-Cal S on the CA-1500, it is essential to mix the contents of each vial of CA-Cal S thoroughly before placing on the CA-1500. Failure to mix the vial thoroughly will result in errors in calibrating the detectors to occur. 1. Turn ON the analyser and allow the analyser to reach ‘Ready’. 2. Press [Special Menu], [Maintain], [Calib. Lamp & LED], and [Calib. LED]. 3. The following message will be displayed on the screen.

4. After mixing the CA-Cal S vial thoroughly, pour contents into a 4 ml Cup and place the 4ml cup into Position D1 of the Reagent Holder Tray. 5. Check the Target Value with the CA CalS package insert. If the value is different use the number pad to input the new value and press Enter Document Ref:SUKBMS-13-259

Page | 10

Version:2.0

Date:03/12/2013

Classification:Company Confidential

6. Press the [Execute] key. Once the [Execute] key is pressed, the following message will be displayed.

7. Press [OK] key 8. The following message will be displayed on the screen.

Document Ref:SUKBMS-13-259

Page | 11

Version:2.0

Date:03/12/2013

Classification:Company Confidential

9. Once the Calibration Sequence has been completed, then a table will be displayed. CH5

296

CH6

OK CH1

274 CH7 OK

288

CH2

OK

243

CH8

OK 293 CH3

OK

266 OK

266

CH4

OK

274 OK

Figure 1. LED Detector State Table. 10. When this table is displayed, confirm all boxes display OK and Press [Set]. 11. Once the detectors have been calibrated, return to the Primary Display.

Checking the LED calibration history. The LED calibration is performed every 31 days. The analyser will automatically alarm informing the Operator when the LED Calibration is required. The LED Calibration will inform the Operator if any detector(s) is failing. If a detector is failing, then the defective detector will be highlighted in Yellow on the table indicating the LED Detector State, shown in step 7 of this procedure. When a detector is highlighted in yellow, the analyser will inform the Operator to contact SYSMEX Service Department to have the failing detector replaced. If a detector(s) has failed, then the faulty detector(s) will be automatically disabled, and will be highlighted in Red. Again, the analyser will inform the Operator to contact SYSMEX Service Department to have the faulty detector(s) replaced. Once the detector(s) has been replaced, then the LED Calibration will enable the detector(s) again. To view the LED Calibration History, then Press [History] key from the [LED Detector State] from the menu shown in step 3 of this procedure. Date 26/3/04

Target 910

CH1 283

Document Ref:SUKBMS-13-259

Page | 12

CH2 179

Version:2.0

CH3 211

CH4 259

CH5 246

Date:03/12/2013

CH6 199

CH7 254

CH8 222

Classification:Company Confidential

29/4/04

Current

910

277

169

210

244

240

199

244

216

275

189

210

250

233

170

240

211

Figure 2. LED Calibration History Table. Once LED Calibration has been performed, particularly when detectors have been replaced, the Operator must re-analyse a Dfbg Standard Curve.

Document Ref:SUKBMS-13-259

Page | 13

Version:2.0

Date:03/12/2013

Classification:Company Confidential

AS REQUIRED MAINTENANCE. Replenishing reaction tubes. If the reaction tubes run short during an analysis, the error message “ replenish reaction tubes” will be displayed. If you supply the instrument while this message is displayed, the analysis will continue without interruption. If there are no more reaction tubes, the analysis will be interrupted and the message “no reaction tubes” will appear. Replenish reaction tubes and the press the [resume] key. The analysis will continue. 1. To open the reaction tube hopper, press on the front part of the cover to pop it up, and then open. 2. Replenish reaction tubes. The reaction tube hopper will hold up to 300 tubes. 3. Close the reaction tube hopper lid.

Chromogenic lamp replacement procedure The life of the Chromogenic lamp is approximately 2000 hours. The lamp is permanently on while the analyser is switched on. The analyser will display the message ‘Replace Lamp Unit’ when the analyser is switched on. WARNING: Before replacing the Chromogenic lamp, ensure that the analyser has been turned OFF and the mains lead has been unplugged. Failure to do so could result in electrical shock. 1. Turn Off the Power and unplug the Mains Lead from the analyser. After turning the analyser off, wait 30 minutes to allow the lamp to cool down. Failure to do so could result in the operators’ fingers being burnt on the lamp. 2. Unscrew the black screw of the exterior lamp cover a couple of turns, which is located on the right side of the instrument. Once the screw has been loosened off then gently slide the cover towards the front of the analyser slightly, pull it out and remove it from the analyser. (See figure 3 below).

Document Ref:SUKBMS-13-259

Page | 14

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Figure 3. Removal of the Exterior Lamp Cover. Once the exterior lamp cover has been removed, the Lamp Cover will now be visible. 3. Loosen the two black thumbscrews, located on the top of the Lamp Cover, and remove the cover by pulling the cover to the right. (See figure 4).

Document Ref:SUKBMS-13-259

Page | 15

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Figure 4. Removal of Lamp Cover. 4. Follow the wires back from the lamp and locate the electrical connector. Once located, press the clamp on one side of the connector and pull the connector apart. (See figure 5).

Document Ref:SUKBMS-13-259

Page | 16

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Figure 5. Disconnecting the electrical connector. 5. Locate the lamp brace. (A gold wire clip holding the lamp in place). Squeeze the two ends of the lamp brace together and remove the lamp from the lamp holder. (See figure 6).

Figure 6. Removal of lamp from lamp holder. 6. Install the new lamp by squeezing together the two ends of the lamp brace and inserting the lamp back into the lamp holder. (See figure 7). Document Ref:SUKBMS-13-259

Page | 17

Version:2.0

Date:03/12/2013

Classification:Company Confidential

Figure 7. Inserting new lamp into lamp holder.

Warning: DO NOT touch the lamp with your fingers, as the grease from your fingers will damage the lamp when the analyser is switched back on. 7. Reconnect the electrical connector that was disconnected in step 4 of this procedure. (See figure 8).

Figure 8. Re-connecting the electrical connector of the lamp. Document Ref:SUKBMS-13-259

Page | 18

Version:2.0

Date:03/12/2013

Classification:Company Confidential

8. Re-fit the lamp cover that was removed in step 3 of this procedure and tighten up the two screws. 9. Re-fit the external lamp cover that was removed is step 2 of this procedure and tighten up the screw. 10. Re-fit the Mains Cable and turn on the analyser. Once the analyser has reached the ‘Ready’ state, the lamp must be allowed to stabilise before the lamp is calibrated. The lamp can be calibrated after 30 minutes has elapsed. 11. From the Main Menu, press [Special Menu], [Maintain], [Calib. Lamp/LED] and [Lamp] keys. 12. The message ‘Close Light Shield Lid and Press Execute Key. Starting Lamp calibration.’ Will be displayed on the screen. 13. The choice of ‘Analyse’ or ‘Not Analyse’* will also be displayed on the screen. 14. Press the [Analyse] key. 15. Close the Light Shield and press the [Execute] key. The lamp calibration will start and the adjustment window will appear. 16. Once the calibration has been completed, press the [Return] key until the Main Menu screen is displayed. Warning: When the lamp has been replaced, QC must be analysed for ALL Chromogenics and Immunoassay tests. If the QC results are out of limits then new Standard Curves will have to be analysed. *If ‘Not Analyse’ is selected, then all the analysis parameters for Chromogenics and Immunological assays will not be able to be performed. If one of these parameters is selected, then an Analysis Error will occur. If a Chromogenics or Immunological Assay is attempted to be analysed after pressing the ‘Not Analyse’ key in micro mode then the sample will not be aspirated. If ‘Analyse’ is selected, then all the analysis parameters for Chromogenics and Immunological Assays will be performed.

Document Ref:SUKBMS-13-259

Page | 19

Version:2.0

Date:03/12/2013

Classification:Company Confidential