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Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS ® ECi/ECiQ Immunodiagnostic System Topic No. Title 1 Cleaning the Sample Supply 2 Performing Intellicheck ® Monitoring 3 Replacing the Sample Metering Proboscis Liner 4 Replacing the Well Wash Aspirate Filter 5 Troubleshooting the Incubator 6 Troubleshooting the Luminometer 7 Troubleshooting Reagent Metering 8 Troubleshooting Reagent Supply 9 Troubleshooting e-Connectivity ®

Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

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Page 1: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Pub. No. J33133_EN2009-11-30

Quick Solutions PacketVITROS® ECi/ECiQ Immunodiagnostic System

Topic No. Title1 Cleaning the Sample Supply

2 Performing Intellicheck® Monitoring

3 Replacing the Sample Metering Proboscis Liner

4 Replacing the Well Wash Aspirate Filter

5 Troubleshooting the Incubator

6 Troubleshooting the Luminometer

7 Troubleshooting Reagent Metering

8 Troubleshooting Reagent Supply

9 Troubleshooting e-Connectivity®

Page 2: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Export authorized under general license GTDA (General Technical Data Available)

IMPORTANTThe information contained herein is based on the experience and knowledge relating to the subject matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.

No patent license is granted by the information.

Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to the information. The company shall not be liable for any loss or damage, including consequential or special damages resulting from the use of this information, even if loss or damage is caused by its negligence or other fault.

VITROS® is a registered trademark of Ortho-Clinical Diagnostics, Inc.

© Ortho-Clinical Diagnostics, Inc., 2009. All rights reserved.

Page 3: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

2009-11-30 J33133_EN

Quick Solutions Packet

Revision History

Revision Date Pages Description

2009-11-30 All Revision to entire document.

2009-07-02 All First release of document.

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J33133_EN 2009-11-30

Quick Solutions Packet

Page 5: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Cleaning the Sample Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.1

Page 1 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: Clean the Sample Tray to remove dust buildup and/or any fluid spills which may impede

sample processing.

Caution: Due to the potential risk of infection, Personal Protective Equipment (PPE) should be worn throughout this procedure.

Required Supplies: • Cotton swabs

• Deionized water • 70% isopropyl alcohol • Lint-free cloth

Estimated Time: 10 minutes

Note: Verify that sample processing is completed prior to performing this procedure.

1. Open the Top Cover of the system.

2. Remove the Universal Sample Trays.

3. Lift the Captured Pins from the Retainer Plate and Tip Disposal Chute.

4. Remove:

• Retainer Plate • 6 Sample Tray Carriers • Tip Disposal Chute

IMPORTANT: The Sample Tray Carriers contain strong magnets, which may interfere with electronic devices. Place the Sample Tray Carriers on a work surface.

5. Clean the following with a lint-free cloth or cotton swab moistened with deionized water, followed by lint-free cloth or cotton swab moistened with 70% isopropyl alcohol:

• Retainer Plate • 6 Sample Tray Carriers • Tip Disposal Chute

Tip Disposal Chute

Retainer Plate

Sample Tray Carrier

Sample Tray Conveyor

Page 6: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Cleaning the Sample Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.1

Page 2 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

6. Clean the Sample Supply area to remove any serum and/or plasma. Use a lint-free cloth or cotton swab moistened with deionized water, followed by lint-free cloth or cotton swab moistened with 70% isopropyl alcohol.

IMPORTANT: Use care when cleaning around the side groove.

IMPORTANT: Only use deionized water to clean the following:

- Sample Barcode Reader

- 2 Sensors

- Tray Positioner

7. Check the spring tension on the Tray

Positioner:

• Use a clean cotton swab to apply gentle pressure to push the Tray Positioner towards the wall of the Sample Supply.

• The Tray Positioner should spring back to original position automatically.

8. Replace the following:

• Tip Disposal Chute

• 6 Sample Tray Carriers

• Retainer Plate

• Universal Sample Trays

9. Press down on the Retainer Plate and Tip Disposal Chute Pins to ensure they are secure.

10. Close the Top Cover and initialize the system.

For more information, contact the OCD Customer Technical Support Center. Supplemental user maintenance instructions for trained operators only.

Sensors

Sample Barcode Reader

Tray Positioner

Universal Sample Tray

Retainer Plate

Page 7: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Performing Intellicheck® Monitoring VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.2

Page 1 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: Perform Intellicheck® monitoring for the following conditions:

• A shift in QC results indicates a process-related issue.

• The result for a sample is not as expected or a flag is displayed.

Subsystem: Intellicheck® verifications are available for the following:

• Sample Metering – verification for clots, bubbles, etc.

• Reagent Metering – verification of overall system performance

• Well Wash – data and exceptions to verify volumes of Universal Wash Reagent

• Signal Reagent – data and exceptions for dispense volume of Signal Reagent

• Sample + Reagent – data and exceptions to verify dispense of sample and assay reagent volumes in the well

• Luminometer – data for self-calibration of Luminometer is performed for each well processed

Estimated Time: 10 minutes

General Overview of System Performance 1. Access Intellicheck® :

a. From the Main Menu, touch Intellicheck Monitoring, then touch System Intellicheck.

2. Select the module to verify in the Subsystem section of the screen (i.e., Sample Metering).

3. Select the parameter to verify in the Verification section of the screen (i.e., Bubble).

Note: The results are displayed in a graph that identifies whether the results are “Out of Limit”. If the results are “Out of Limit”, refer to the Quick Solution Packet for the specific module for more information on troubleshooting. The resolution may include performing the regular maintenance on the system.

4. Touch Return to return to the Main Menu.

Note: If unable to resolve the issue, contact the OCD Customer Technical Support Center.

Page 8: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Performing Intellicheck® Monitoring VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.2

Page 2 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Checking Sample Performance 1. Access the Results Review Screen. Touch:

• Results Review

• Search/Review/Edit

• Review/Edit

2. Select Sample ID.

3. Touch Result Intellicheck.

4. Determine if this is a sample or process-related issue. A sample related issue will tend to be unique but a process

related issue may affect multiple samples/tests.

a. If “Out of Limit” is displayed, repeat the sample.

b. If it is a process issue, the system may require an additional performance check. Refer to the Quick Solution Packet for the specific module for more information on troubleshooting.

5. Touch Return to return to the Main Menu.

Environmental Monitoring 1. From the Main Menu, touch Intellicheck Monitoring, then touch Environmental Monitoring.

2. Touch Start Monitoring to obtain information that is updated every 10 seconds.

3. Touch View More Detail.

Note: Use this screen to monitor voltages and temperatures, including the coil temperature. 4. Touch Help for additional information.

For more information, contact the OCD Customer Technical Support Center. Supplemental user maintenance instructions for trained operators only

Page 9: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Replacing the Sample Metering Proboscis Liner VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.3

Page 1 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

Overview: If condition codes indicate high or low pressure, replace the Sample Metering Proboscis

Liner. The following condition codes may display:

• E01-052, E01-059: The sample has a clot or high viscosity.

• The Disposal Tip is plugged.

• The Proboscis or tubing is plugged.

• E01-055: Two consecutive Sample Metering aspirates did not occur.

• E01-054: Unable to locate sample fluid.

• E01-164: Sample Metering compressed air flow rate low.

Caution: Due to the potential risk of infection, Personal Protective Equipment (PPE) should be worn throughout this procedure.

Required Supplies: • Protective disposable gloves • Straight Safety Blade • Sample Metering Proboscis Liner

Estimated Time: 10 minutes

Note: The Proboscis Liner is threaded through an opening in the Sample Metering Probe. The Proboscis Liner is attached to the Sample Metering Pump and exits through the end of the Sample Metering Probe. 1. Open the Top Cover of the system.

2. Unscrew the black fastener attaching the

Proboscis Liner to the Sample Metering Pump.

3. Pull the Proboscis Liner completely out of the

Proboscis.

Black Fastener

Proboscis Liner

Page 10: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Replacing the Sample Metering Proboscis Liner VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.3

Page 2 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

4. Screw the black fastener for the new

Proboscis Liner into the Sample Metering Pump.

IMPORTANT: Use caution not to cross the threads during installation. Do not over tighten the black fastener.

5. Thread the new Proboscis Liner through the opening on the right side of the Proboscis.

6. Pull the Proboscis Liner down through the opening at the bottom of the Proboscis. Ensure that the section of the Proboscis Liner with the thicker diameter is pulled through the opening.

Note: To make pulling the Proboscis Liner easier, wrap the solid lead of the new liner around your finger and hold the Proboscis so that it does not drop down as you pull.

IMPORTANT: Pull the Proboscis Liner’s Protective Jacket toward the opening of the Sample Metering Arm. Do not pull the Protective Jacket into the Proboscis.

Thicker Diameter

Thinner Diameter

Protective Jacket

Sample Metering Arm Opening

Page 11: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Replacing the Sample Metering Proboscis Liner VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.3

Page 3 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

7. Cut the Proboscis Liner flush with the end of

the Proboscis with a straight safety blade.

IMPORTANT: Do not use scissors to cut the Proboscis Liner.

8. Close the Top Cover of the system.

9. Initialize the Sample Metering Arm. Touch:

• Diagnostics

• Mechanism Exercise Diagnostics (MEDs)

• Sample Metering

• Metering Arm

• Initialize

• Start

10. Run QC to verify system performance.

11. Contact the OCD Customer Technical Support

Center if condition codes still display.

For more information, contact the OCD Customer Technical Support Center.

Supplemental user maintenance instructions for trained operators only.

Page 12: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Replacing the Sample Metering Proboscis Liner VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.3

Page 4 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

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Replacing the Well Wash Aspirate Filter VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.4

Page 1 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009—11-30 J33133_EN

Overview: Replace the Well Wash Aspirate Filter when presented with error code J01-060 or J01-061.

Caution: Avoid spilling fluids. Personal Protective Equipment (PPE) should be worn throughout this procedure to prevent any risk of injury.

Required Supplies: Well Wash Aspirate Filter

Estimated Time: 10 minutes

1. Open the Top Cover of the system.

2. Hold the Aspirate Filter firmly as you remove the Filter Adapter from the top of the Well Wash Aspirate Filter.

3. Remove the Well Wash Aspirate Filter from

the manifold. 4. Install the new Aspirate Filter by rotating it

clockwise into the manifold. Do not over tighten.

5. Install the Filter Adapter and Aspirate Tubing

by rotating the Filter Adapter clockwise into the top of the Well Wash Aspirate Filter.

6. Check that the tubing is firmly seated in the

Filter Adapter.

7. Close the Top Cover.

8. On the Screen, touch Initialize.

9. Run QC to verify system performance.

IMPORTANT: Dispose of the old Aspirate Filter by placing it in a Biohazard Waste Receptacle.

For more information, contact the OCD Customer Technical Support Center.

Supplemental user maintenance instructions for trained operators only.

Tubing

Filter AdapterAspirate Filter

Well Wash Manifold

Page 14: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Replacing the Well Wash Aspirate Filter VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.4

Page 2 of 2 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009—11-30 J33133_EN

Page 15: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 1 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: When a “jam” occurs in the Incubator, open the Incubator and check for fluid. The Incubator

Rings, Well Shuttle, and Lift Pins, must all be completely clean and dry before reassembly to avoid additional issues.

Caution: Due to the potential risk of infection, Personal Protective Equipment (PPE) should be worn throughout this procedure. IMPORTANT: Before you begin this procedure, confirm that solid waste in the Solid Waste Container is not blocking the Incubator. Otherwise, the solid waste may back up into the Incubator and cause a jam.

Required Supplies:

• Cotton swabs • Deionized water • 70% isopropyl alcohol • Lint-free cloth • Large Phillips Screwdriver

Estimated Time: 15 minutes and time to perform QC

IMPORTANT: Use a cotton swab moistened with deionized water or 70% alcohol to clean all parts, unless instructed otherwise. Note: All parts must be dry before reassembly. Dry with a clean cotton swab or lint-free cloth. 1. Open the Top Cover. 2. Lift and move the Well Wash and Signal

Reagent Arms to the maintenance position. 3. Lift the Luminometer. 4. Open the Incubator Cover. 5. Disengage the Drive Gears from the Incubator

Rings. 6. If necessary, move the Well Shuttle back

away from the Rings. 7. Remove the Inner and Outer Incubator Rings:

a. Inspect the Incubator Rings for wetness/residue.

b. Clean the Rings thoroughly to remove any residue inside and outside the Rings.

c. Place the Inner and Outer Rings on a work surface to dry.

8. The Sensors that are monitoring the rotation of the Incubator Rings may be dirty. Clean the Sensors with deionized water.

9. Clean the Evaporation Cover and Lower Heat Plate with deionized water.

Inner Ring

Outer Ring

Evaporation Cover

Lower Heat Plate

Well Shuttle

Drive Gears

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Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 2 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

10. Remove the Well Shuttle Weight. IMPORTANT: Remove the Well Shuttle Weight carefully to avoid scratching the inside surface of the Well Shuttle. Use a wooden applicator stick if necessary.

11. Clean the inside of the Well Shuttle and the Well Shuttle Weight with deionized water.

12. Dry and replace the Well Shuttle Weight.

Note: For correct installation of the Well Shuttle Weight ensure that the flat surface is facing up.

Well Shuttle Weight

Well Shuttle

Page 17: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 3 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

13. Use Mechanism Exercise Diagnostics (MEDs) to

raise the Inner Lift Pin. Touch:

• Diagnostics

• MEDs

• Incubator

• Inner Lift

• Move

• Read

• Start

14. Clean the Inner Lift Pin with deionized water

and dry the Inner Lift Pin. 15. Lower the Inner Lift Pin.

Touch:

• Home

• Start 16. Use MEDs to raise the Outer Lift Pin.

Touch:

• Outer Lift

• Up

• Start

17. Clean and dry the Outer Lift Pin with

deionized water. 18. Lower the Outer Lift Pin

Touch:

• Down

• Start

Page 18: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 4 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Removing the Well Shuttle and Clearing an Obstruction

1. Move the Incubator Shuttle toward the back of the system, away from the Lift Pins.

2. Use a large Phillips Screwdriver to loosen the 3 Screws that hold the assembly.

3. Move the Well Shuttle aside to clear the debris from under the Well Shuttle.

Note: Move the Well Shuttle only slightly out of position since a signal cable is still attached.

4. Reseat the Well Shuttle and tighten the 3 Screws.

5. Verify that the Fiber Optic Bundle (FOB) on the Luminometer is clean. To clean the FOB:

a. Use a cotton swab wrapped with a Lint-free cloth and moistened with deionized water. Gently rub any debris off the FOB. IMPORTANT: Do Not Use Alcohol.

b. Dry the FOB with a clean cotton swab wrapped with a Lint-free cloth.

c. Allow all surfaces to air dry.

Note: Contact the OCD Customer Technical Support Center for an adjustment if the FOB is frequently dirty.

FOB

3 Screws

Well Shuttle

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Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 5 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

6. Install the Inner and Outer Rings and engage the Drive Gears by pulling up on the Pins.

7. Close the Incubator Cover.

8. Lower and lock the Luminometer.

9. Move the Well Wash and Signal Reagent Arms into the correct position over the Incubator.

10. Close the Top Cover.

11. Press Return to return to the Main Menu. 12. Initialize the system.

13. Perform Luminometer IRS Calibration.

Note: See Guide No. 6, Troubleshooting the Luminometer, for instructions on performing the Luminometer IRS Calibration. 14. Perform QC to verify system performance.

For more information, contact the OCD Customer Technical Support Center.

Supplemental user maintenance instructions for trained operators only.

Signal Reagent Arm

Well Wash Arm

Pins

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Troubleshooting the Incubator VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.5

Page 6 of 6 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

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Troubleshooting the Luminometer VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.6

Page 1 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

Overview: This operation is performed when:

• Condition codes 451-027, 541-016, or 541-018 are displayed

• It is necessary to clean the Fiber Optic Bundle (FOB) and/or Incubator Reference System (IRS).

Caution: Due to the potential risk of infection, Personal Protective Equipment (PPE) should be worn throughout this procedure.

Required Supplies: • Cotton swabs • Deionized water • Isopropyl alcohol • Lint-free cloth

Estimated Time: 5 minutes and time to perform QC

IMPORTANT: If the power has been turned off, allow approximately 10 minutes to warm up the IRS before beginning the IRS calibration. 1. Open the Top Cover.

2. Move the Well Wash and Signal Reagent

Arms.

3. Lift the Luminometer.

4. Open the Incubator Cover.

5. Clean the IRS:

a. Apply very light pressure to prevent dislodging the IRS.

b. Use a cotton swab moistened with deionized water.

c. Gently wipe with a lint-free cloth moistened with isopropyl alcohol.

IRS

Page 22: Quick Solutions Packet - Ortho Clinicaldocuments.orthoclinical.com/clindiag/ocdFILES.nsf/e8bbc...Pub. No. J33133_EN 2009-11-30 Quick Solutions Packet VITROS® ECi/ECiQ Immunodiagnostic

Troubleshooting the Luminometer VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.6

Page 2 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

6. Verify that the Fiber Optic Bundle (FOB) has been recently cleaned.

7. If necessary, clean the FOB using the procedures starting with step 5 on page 4 of Guide No. 5.

8. If condition codes are still displayed, perform

Weekly Maintenance on the Incubator and clean the Incubator Inner and Outer Rings.

9. If the Fiber Optic Bundle is frequently dirty, verify that the Incubator Inner Lift Pin shaft is clean. If necessary, clean the Incubator Inner Lift Pin, using the procedures starting with step 13 on page 3 of Guide No. 5.

10. Identify any damage to the IRS filter.

• The filter should be flat and clean.

• If the IRS Filter is damaged, contact the OCD Customer Technical Support Center for service.

11. Close the Incubator Cover.

12. Lower and lock the Luminometer.

FOB

Inner Lift Pin

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Troubleshooting the Luminometer VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.6

Page 3 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

13. Move the Well Wash and Signal Reagent Arms into the correct position over the Incubator.

14. Close the Top Cover.

IMPORTANT: Verify that the Incubator Cover is closed and that the Luminometer is in the “down” position before doing the IRS calibration. 15. Perform an IRS calibration. Touch:

• Diagnostics

• Calibrate Subsystems

• Calibrate Luminometer and enter the access code (68370668)

• IRS Calibration

• Yes

Note: When the test is completed, “Calibration Successful” is displayed and the DAC Values screen is updated showing the before and after values. 16. When the test completes, touch:

• OK

• Return

17. Run Luminometer Read Sequence. Touch:

• Diagnostics

• Mechanism Exercise Diagnostics (MEDs)

• Read

• Luminometer

• Photon

• Sequences

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Troubleshooting the Luminometer VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO.6

Page 4 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic Chemistry System.

2009-11-30 J33133_EN

Enter a value of “1” in the Position field and touch Enter.

18. Verify a value of “1” is displayed in the Actuation field.

• If necessary, enter a value of “1” and touch Enter.

• Touch Start

• Touch Display Data when the test is complete.

Note: Data similar to the example on the right will display.

DIAGNOSTIC – MEDs – Display Data Actuation Dark Signal

Read Incubator Reference

Internal Reference

Adjusted Signal

1 20 30 1996372 2009066 10

The following conditions should be met:

o Dark reading should be less than 100. If greater than 100, check that the Luminometer is closed securely and no strong light is over the Luminometer.

o Signal reading should be less than 150. If it is greater than 150 and dark reading is less than 100, call the OCD Customer Technical Support Center for additional information.

o Internal Reference should be within the range of 1,650,000 - 2,350,000. If the value is outside this range and dark reading is less than 100, call the OCD Customer Technical Support Center for additional information.

19. If the results are within expected parameters:

a. Press Return 4 times to return to the Main Menu.

b. Run QC to verify system performance.

For more information, contact the OCD Customer Technical Support Center.

Supplemental user maintenance instructions for trained operators only.

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Troubleshooting Reagent Metering VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 7

Page 1 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: To resolve issues associated with the Reagent Metering, follow this procedure when:

• Condition Code F02-196 or F02-194 is displayed

• Error codes indicate reagents not detected

• Incubator Cover shows evidence of a fluid leak

Caution: Due to the potential risk of infection, Personal Protective Equipment (PPE) should be worn throughout this procedure.

Estimated Time: 10 minutes

Troubleshooting Reagent Metering:

1. Open the Top Cover.

2. Lift the white Interlock Switch in the front left corner.

3. Initialize Reagent Metering. Touch:

• Diagnostics

• Mechanism Exercise Diagnostics (MEDs)

• Reagent Metering

• Initialize Metering

Interlock Switch

Reagent Probe

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Troubleshooting Reagent Metering VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 7

Page 2 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

4. During the initialization process check that Reagent Metering is moving freely and there are no physical obstructions.

5. When Reagent Metering has initialized, verify

the Reagent Probe is centered over the Wash Station. If it is not, contact the OCD Customer Technical Support Center.

6. Touch:

• Reagent Metering

• Prime

• Start

7. Verify that liquid is being dispensed into the Wash Station. a. If deflection of the Probe is seen, call the

OCD Customer Technical Support Center.

b. If no condition codes are displayed, close the Top Cover and return to the Main Menu and reprocess the samples.

c. If condition codes are displayed, proceed to the following step.

8. Verify that the Reagent Probe is tight.

a. Lower the Interlock Switch (see step 2).

b. Move the Reagent Metering Arm to the right, toward the Incubator.

c. Pull the black Drive Belt towards you until the Screw at the top of the Reagent Probe is visible.

d. Check that the top of the Reagent Probe is tight.

Wash Station

Drive Belt

Reagent Metering Probe

Reagent Metering Arm

Reagent Probe

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Troubleshooting Reagent Metering VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 7

Page 3 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Performing a Leak Check 1. Check the performance of the Reagent Pump,

located between the Reservoir Bottle and the Vacuum/Pressure toggle switches. a. Check for wetness/crystals. b. Tighten the 6 Blue Connectors.

IMPORTANT: Do not use pliers or any other tool to tighten the Blue Connectors as damage may result.

2. On the MEDs Screen, touch:

• Purge

• Start – wait for action to complete

• Wash Probe

3. Enter “5” on the keyboard, then press Enter.

4. Touch Start.

5. Observe the Reagent Pump to identify if there are any leaks or air bubbles in the transparent section of the Pump.

a. If leaks or air bubbles are present, repeat prime and purge actions to remove the air.

b. If errors are posted or bubbles are still present, perform 5 Purges and repeat Probe Wash.

6. Close the Top Cover.

7. Return to the Main Menu.

For more information, contact the OCD Customer Technical Support Center. Supplemental user maintenance instructions for trained operators only.

Reagent Pump

Blue Connector

Transparent Section

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Troubleshooting Reagent Metering VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 7

Page 4 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

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Troubleshooting Reagent Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 8

Page 1 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: When a “jam” occurs in the Reagent Supply, it is necessary to open the Reagent Supply

Cover and check for a jammed Reagent Pack or an obstruction in the Well Shuttle.

Estimated Time: 10 minutes

1. Open the Top Cover.

2. Open the Reagent Supply Cover.

Note: The Reagent Pack Shuttle is visible when loading Reagent Packs, unless the Reagent Supply is full.

3. If the Reagent Supply is not full, verify that the

position of the Reagent Pack Shuttle is outside the Reagent Supply.

Note: The inner door provides access to the Carousel and Reagent Packs.

4. Examine the Reagent Pack Shuttle for

damage. The Blade should be straight.

Reagent Supply Cover

Inner Door

Reagent Pack Shuttle

Reagent Pack Shuttle

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Troubleshooting Reagent Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 8

Page 2 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

5. View the Reagent Packs in the Reagent Carousel.

a. Verify that the Reagent Packs are seated correctly.

b. Carefully rotate the Carousel using the Reagent Packs.

c. If the Carousel turns easily, replace the Reagent Supply Cover.

6. If the Carousel does not turn easily, touch:

• Diagnostics

• Mechanism Exercise Diagnostics (MEDs)

• Reagent Supply

• Carousel

• Initialize

• Start

7. Return to the Main Menu.

8. If the Carousel does not rotate after pressing Start (step 6), touch:

• Reagent Supply

• Well Dispenser

• Initialize

• Start

• Well Shuttle

• Initialize

• Start

Reagent Packs

Carousel

Well Shuttle

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Troubleshooting Reagent Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 8

Page 3 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Note: If the Well Shuttle initialization process completes, there is no obstruction between the Well Shuttle and Reagent Pack. 9. On the Display Screen, touch:

• Carousel

• Initialize

• Initialize Supply 10. Close the Top Cover.

11. Return to the Main Menu.

Note: The system initialization process begins.

Note: Contact the OCD Customer Technical Support Center if the Well Shuttle initialization process does not begin.

For more information, contact the OCD Customer Technical Support Center.

Supplemental user maintenance instructions for trained operators only.

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Troubleshooting Reagent Supply VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 8

Page 4 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

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Troubleshooting e-Connectivity® VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 9

Page 1 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Overview: To resolve issues associated with e-Connectivity®, follow this procedure when:

• Condition Codes indicate e-Connectivity® session was unsuccessful.

• Condition Code 710-005 is displayed: “Unable to establish a connection to the server”.

Estimated Time: 10 minutes

Determine VPN Router Version 1) Determine the version of e-Connectivity®

installed on the analyzer:

a) Look on the back of the analyzer.

b) Identify the VPN Router version (see images at the right):

o If an external VPN router is present, follow the steps in the Troubleshooting External VPN Router section of this procedure.

o If an internal VPN router is present, follow the steps in the Troubleshooting Internal VPN Router section of this procedure.

External VPN Router

Internal VPN Router

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Troubleshooting e-Connectivity® VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 9

Page 2 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Troubleshooting External VPN Router 1. Verify that the Ethernet Cable plugged into the

WAN port on the VPN Router is also plugged into the lab network port.

Note: The WAN LED is illuminated if the connection is successful.

2. Verify that the Ethernet Cable plugged into the

back of the analyzer is also plugged into the LAN1 port.

Note: The LAN1 LED is illuminated if the connection is successful.

3. Reset the External VPN Router:

a. Remove the Power Cord connection from the Router and wait 30 seconds.

b. Reconnect the Power Cord to the Router.

4. Establish an e-Connectivity® session. Touch:

• Diagnostics • Start e-Connectivity • OK Note: The e-Connectivity® icon in the Status Console will turn green if the e-Connectivity®

session is successful.

Power Cord

LAN1

WAN

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Troubleshooting e-Connectivity® VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 9

Page 3 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN

Troubleshooting Internal VPN Router 1. Verify that the Ethernet Cable plugged into the

Ethernet port in the back of the analyzer is also plugged into the lab network port.

2. Reboot the analyzer.

3. Establish an e-Connectivity® session. Touch:

• Diagnostics • Start e-Connectivity • OK Note: The e-Connectivity® icon in the Status Console will turn green if the e-Connectivity®

session is successful.

For more information, contact the OCD Customer Technical Support Center. Supplemental user maintenance instructions for trained operators only.

Ethernet Cable

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Troubleshooting e-Connectivity® VITROS® ECi/ECiQ Immunodiagnostic System

GUIDE: NO. 9

Page 4 of 4 Refer to the VITROS is a trademark of Ortho Clinical Diagnostics, Inc.

This document is a troubleshooting aid only. Refer to the appropriate documentation for the VITROS ECi/ECiQ Immunodiagnostic System.

2009-11-30 J33133_EN