ADVIA-2120i Hematology Training [PDF]

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ADVIA® 2120i Hematology System

Virtual Training Workbook

Siemens Healthineers ADVIA® 2120i Hematology System Virtual Training Workbook

ADVIA® 2120i Hematology System

T02006.005

Effective Date: 02/22/2021

© 2021 Siemens Healthineers Inc. All rights reserved. This manual, and the software described in this manual, are copyrighted. No part of this may be copied, reproduced, translated or reduced to any electronic medium or machine-readable form without the prior written consent of Siemens Healthineers. ADVIA, TESTpoint, OPTIpoint, SETpoint and TIMEPAC are trademarks of Siemens Healthcare Diagnostics Inc. All other trademarks are the property of their respective owners.

ii

ADVIA® 2120i Hematology System

Table of Contents 1:

Welcome

2:

System Overview

3:

Starting Each Shift

4:

Quality Control I

5:

Sample Processing

6:

How the System Works

7:

Methods

8:

Quality Control II

9:

Scheduled Maintenance

10:

Gains

11:

Calibration

12:

Troubleshooting

ADVIA® 2120i Hematology System

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iv

ADVIA® 2120i Hematology System

Welcome

1 Welcome Welcome to Training Siemens Healthineers Training would like to welcome you to basic operator training on the ADVIA 2120i Hematology System. This course is designed to teach you the skills needed to operate and maintain the ADVIA 2120i Hematology System. Our staff welcomes the opportunity to present this virtual training program to you.

Training Material This training workbook includes an agenda, learning goals, and practical exercises.

ADVIA® 2120i Hematology System

1-1

Welcome

Course Objectives Upon completion of the class, you will be able to:

1-2

•

Identify system hardware components and reagents

•

Navigate through software menus

•

Perform Starting each Shift

•

Prepare and perform Quality Control processing

•

Demonstrate how to import a new lot of QC

•

Perform sample processing

•

Describe how the system works

•

Perform and record scheduled maintenance

•

Identify the methods used on the system

•

Review the gains adjustment process using the Gains Wizard

•

Review the calibration process using the Calibration Wizard

•

Utilize the Operator’s Guide to locate sample / system flags

ADVIA® 2120i Hematology System

Welcome

Agenda Day 1 •

System Overview

•

Starting Each Shift

•

Quality Control I

•

Sample Processing

•

How the System Works

•

Methods

•

Quality Control II

Day 2 •

Scheduled Maintenance

•

Gains

•

Calibration

•

Troubleshooting

ADVIA® 2120i Hematology System

1-3

Welcome

ADVIA® 2120i Hematology System Virtual Training Course Validation Checklist The participant places a checkmark beside the competency when it is completed. When all competencies are checked, the Observer and Participant sign and date below as record of completion.

Topics

Competencies

Completed

System Overview

Identify system hardware components Identify system reagents Navigate the key areas of the software

Starting each Shift

List the steps for Starting each Shift List the steps to empty waste Locate and check the overflow bottle Recognize reagent inventory needs and replace if needed Evaluate background counts

Quality Control

Prepare and perform Quality Control processing Review and validate QC results Demonstrate how to import a new lot of QC data Interpret QC data Demonstrate printing and exporting of QC reports

Sample Processing

Perform sample processing in all modes (Autosampler, MOTS, and MCTS) Identify the sample statuses Locate and validate sample results Demonstrate printing of sample results Use Order Entry to create workorders Use Manual Sample ID option to enter samples

How the System Works

Identify UFC components Identify the steps of sample processing Resolve probe clog and aspiration failure messages Perform clot filter replacement

1-4

ADVIA® 2120i Hematology System

Welcome

Topics

Competencies

Methods

Identify the components of the hemoglobin transmission

Completed

Identify cell populations on RBC, Platelet, Retic, Perox and Baso cytogram Scheduled Maintenance

Perform turning off the system Perform wipe the shear valve maintenance Perform automatic hydraulic pathways maintenance Perform clean Autosampler centering collar maintenance Perform semi-automatic vent line wash Perform replacement of RBC/Baso and Perox Sheath filters Perform clean the air-circulation filter maintenance Record maintenance in the Service Log

Gains

Identify when to adjust gains Identify what to check before adjusting gains Review the gains adjustment process using the Gains Wizard

Calibration

Identify when to calibrate Identify what to check before calibrating Review the calibration process using the Calibration Wizard

Troubleshooting

Utilize the Operator’s Guide to locate morphology and sample/system flags Identify troubleshooting basics Perform shear valve cleaning

ADVIA® 2120i Hematology System

1-5

Welcome

Observed By:

__________________________________________________

Participant:

__________________________________________________

Date:

__________________________________________________

What was most helpful to you during this program?

How can we improve this program to make it more meaningful to you?

1-6

ADVIA® 2120i Hematology System

System Overview

2 System Overview

ADVIA® 2120i Hematology System

2-1

System Overview

System Overview Resources •

ADVIA 2120i Hematology System Hardware and Software Online Training Course

•

ADVIA 2120/2120i Hematology Systems Operator’s Guide

•

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

2-2

•

Identify system hardware components

•

Identify system reagents

•

Navigate key areas of the software

ADVIA® 2120i Hematology System

System Overview

Identify System Hardware Components Refer to the ADVIA 2120i Hematology System Quick Reference Guide and identify component accordingly. 1. Unified Fluids Circuit (UFC) 2. Waste Container 3. Laser Optical Assembly 4. Perox Optical Assembly 5. Autosampler 6. Overflow Bottle 7. Sheath/Rinse 8. Syringe Pump Assembly Left and Right 9. Touchpad 10. Manual Open-Tube Sampler (MOTS) 11. Manual Closed-Tube Sampler (MCTS) 12. Reagents 13. Hgb Optical Assembly

ADVIA® 2120i Hematology System

2-3

System Overview

Identify System Reagents 1. Which reagent is not on board the analyzer?

2. Which reagents are bundled together?

3. List the reagents on the right side of the instrument

4. List the reagents on the left side of the instrument.

Navigate Key Areas of the Software 1. Identify the following icons located on status line 1. A

B

C

A. B. C. 2. What is the current status of your analyzer?

and note the last date recorded for the Turning off 3. Select the service icon the System maintenance task.

2-4

ADVIA® 2120i Hematology System

System Overview

4. Select Info > About. What is the software version listed for this analyzer?

5. In the Data Manager > Sample Control Panel, how many samples are pending?

6. Select Customize > Tools View > Routine Parameters. How do you return to the Sample Control Panel?

7. Go to Logs > Reagent log. What is the expiration date of the ADVIA Sheath/Rinse?

ADVIA® 2120i Hematology System

2-5

Starting Each Shift

3 Starting Each Shift

ADVIA® 2120i Hematology System

3-1

Starting Each Shift

Starting Each Shift Resources •

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

3-2

•

List the steps for Starting each Shift

•

List the steps to empty waste

•

Locate and check the overflow bottle

•

Recognize reagent inventory needs and replace if needed

•

Evaluate background counts

ADVIA® 2120i Hematology System

Starting Each Shift

Starting Each Shift Use the ADVIA 2120i Hematology System Quick Reference Guide to complete the following exercises.

Empty the Waste Container and Check the Overflow Bottle 1. Practice emptying the waste. 2. Verify the overflow bottle is empty.

Check the Status of Reagent Inventory: Replace Reagents if Needed 1. Are any reagents in need of replacement? If so, replace reagents. 2. What two reagents are NOT monitored on cycle by cycle basis? Hint: From Startup screen, select the Help button. Click on “Check the Reagent Status.” 3. What reagent must be checked visually each start of shift?

Evaluate the Background Counts Navigate to Operations > Startup. 1. How can you verify background counts are in range? 2. How does the software display a background count that is out of range? 3. What is your first course of action if the background counts are out of range? 4. If the background counts are still out of range, what would be the next course of action? Now, perform that action.

ADVIA® 2120i Hematology System

3-3

Starting Each Shift

3-4

ADVIA® 2120i Hematology System

Quality Control I

4 Quality Control I

ADVIA® 2120i Hematology System

4-1

Quality Control I

Quality Control I Resources •

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

4-2

•

Prepare and perform Quality Control processing

•

Review and validate QC results

ADVIA® 2120i Hematology System

Quality Control I

Prepare and Run QC Refer to the ADVIA 2120i Hematology System Quick Reference Guide and the control package insert to prepare the instrument and control material for processing. 1. Refer to the ADVIA TESTpoint™ package insert to complete the following statement. Controls are brought to __________ temperature and must be well __________ before they are run. 2. Which status must the instrument display before you can run controls? 3. Run the provided controls in all three modes.

Review and Validate QC Refer to ADVIA 2120i Hematology System Quick Reference Guide. 1. Select each control in the list and view the status of the parameters in the Test Panel.

2. Define the color coding in the Sample Control Panel. a. Green: b. Yellow: c. Red: 3. What does an asterisk (*) in front of a QC control code indicate?

4. Select a control with an asterisk (*). What must be done to validate the control?

5. Which icon did you select to validate the control?

ADVIA® 2120i Hematology System

4-3

Quality Control I

6. How did the control change in the Sample Control Panel?

7. Print the report from Review/Edit screen for this control.

4-4

ADVIA® 2120i Hematology System

Sample Processing

5 Sample Processing

ADVIA® 2120i Hematology System

5-1

Sample Processing

Sample Processing Resources •

ADVIA 2120i Hematology Systems Quick Reference Guide

Objectives After completing this exercise, you will be able to:

5-2

•

Process samples on Autosampler, Manual Open-tube sampler, and Manual Closed-tube Sampler

•

Identify the sample status

•

Locate and validate sample results

•

Use Manual Sample ID option to enter samples

•

Use Order Entry to create workorders

ADVIA® 2120i Hematology System

Sample Processing

Process Barcoded Samples on the Autosampler, Manual OpenTube Sampler, and Manual Closed-Tube Sampler 1. Process each of the barcoded samples at the workstation using the Autosampler, MOTS, and MCTS.

2. Process the non-barcoded tube in the MCTS mode.

Identify Sample Status Navigate to the Data Manager > Sample Control Panel 1. Which sample status now contains the barcoded sample results?

2. Open the unmatched folder. What did you find in the folder?

Review and Validate Sample Results Navigate to Data Manager > Sample Control Panel. Select Incomplete and scroll through each patient’s results. 1. Circle the icon that is used to validate sample results?

2.

ADVIA® 2120i Hematology System

Select the validate button. What sample status now contains newly validated sample results?

5-3

Sample Processing

Order Entry and Manual Sample ID 1. Select Data Manager > Order Entry. Create a patient with a SID# and name and order a CBC/Diff for one of the non-barcoded samples at your workstation. Create a second workorder for the other non-barcoded tube provided.

2. Select Operations > Manual Sample ID. With patient data already entered in Order Entry, enter Sample ID into Manual Sample ID and process using the MOTS. Repeat process for the other created workorder.

3. Review and validate all processed samples.

4. Obtain printout of final patient reports.

5. Bring final reports to the table.

5-4

ADVIA® 2120i Hematology System

How the System Works

6 How the System Works

ADVIA® 2120i Hematology System

6-1

How the System Works

How the System Works Resources •

ADVIA® 2120i Hematology System How the System Works Online Training: The Fluidics Process Video

•

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

6-2

•

Identify UFC components

•

Identify the steps of sample processing

•

Resolve probe clog and aspiration failure messages

•

Perform clot filter replacement

ADVIA® 2120i Hematology System

How the System Works

Unified Fluids Circuit (UFC)

UFC VAC

HGB

VENT PORTS

8

VSC

To PEROX sample syringe

18

6

22

7

4 46

44 35

72

SSV

73

31 2

74

61 VA C U U

M

1

10 33

From RBC/BASO/RETIC CFM To RBC/BASO/RETIC sample syringe

11 9 49

RETICS

COUPLER PLATE

3

21

43

EQUIL

45

12

20

VSC

17

5

13

RBC

16

14

PEROX

From PEROX CFM

36

BASO

37

65

66 64

47 WASTE

SSV = sample shear valve VSC = vacuum shuttle chamber CFM = concentric flow module

ADVIA® 2120i Hematology System

6-3

How the System Works

Identify Shuttling Process 1. View The Fluidic Process Video and put the following sequence in the correct order: shear valve turns to the dispense position MCTS needle is rinsed green Ready light stops flashing and MCTS needle retracts sample reaches conductivity detector #1 reagents are dispensed sample reaches conductivity detector #2 Ready light is green sample is aspirated via MCTS

2. Aspirate a sample in the Manual Closed-tube sampler (MCTS) and observe the aspiration cycle. a. Which of the chambers is shuttled to a flowcell via a syringe FIRST? __________________________________________________________ b. What reaction chamber empties just before the perox chamber is shuttled to the flowcell via syringe? __________________________________________________________ c. Which chamber is not shuttled to a flowcell via a syringe? __________________________________________________________ d. How can you easily identify the Retic chamber? __________________________________________________________

6-4

ADVIA® 2120i Hematology System

How the System Works

Troubleshoot Probe Clog / Aspiration Failure Messages Status-line Message Errors:

Probe Clog Conductivity detector 1 did not detect a sample within 20 seconds of aspiration.

Aspiration Failed - Probe Clog Conductivity detector 2 did not detect a sample within the 20 seconds of aspiration.

ADVIA® 2120i Hematology System

6-5

How the System Works

Replace the Clot Filter 1. Analyzer Mode: Standby 2. Unscrew the filter tube fitting and tube assembly from the front of the selector valve. 3. Gently push the silicone sleeve to release the clot filter from the filter adapter fitting. 4. Visually check the filter adapter fitting and the input port of the selector assembly for any debris or small particles. 5. If you find some debris, use a piece of lens tissue moistened with water to remove it. 6. Wet the new clot filter with water and place it into the filter adapter fitting. 7. Orientation of the filter is not important. 8. Reconnect the filter adapter fitting to the selector valve. Finger tighten. Important: Be very careful not to misthread the fitting. Misthreading could strip the valve which will prevent proper operation. 9. Press Standby to return analyzer to Ready to Run mode. 10. Run a sample and visually check for air bubbles in the sample line between the selector valve and the UFC block.

Selector valve

Filter tube fitting

6-6

ADVIA® 2120i Hematology System

How the System Works

Effects of Overtightening the Clot Filter Normal Clot Filter

ADVIA® 2120i Hematology System

Overtightened Clot Filter

6-7

Methods

7 Methods

ADVIA® 2120i Hematology System

7-1

Methods

Methods Resources •

ADVIA 2120i Hematology System Quick Reference Guide

•

ADVIA 2120/2120i Hematology Systems Operator’s Guide

Objectives After completing this exercise, you will be able to:

7-2

•

Identify components of hemoglobin transmission

•

Identify cell populations on the RBC, platelet, retic, baso and perox cytogram

ADVIA® 2120i Hematology System

Methods

Hemoglobin Method Exercise 1. Hemoglobin reagent is part of which TIMEPAC®?

2. Identify the five parts of the hemoglobin transmission histogram.

___ Sample reading ___ Sheath/Rinse reading from previous cycle ___ Sheath/rinse Baseline reading ___ Draining and refilling with sample and HGB reagent ___ Draining and refilling with Sheath/Rinse

ADVIA® 2120i Hematology System

7-3

Methods

RBC Method Exercise 1. Label the RBC V/HC cytogram to indicate where the following cell types are located. Microcytic

Hyperchromic

Macrocytic

Hypochromic

2. Which reagent encases the sample stream as it goes through the RBC flowcell? Where is this reagent located on the system?

7-4

ADVIA® 2120i Hematology System

Methods

Platelet Method Exercise 1. Identify the different areas of the platelet cytogram. ___ Platelets ___ RBC ghosts ___ RBC fragments ___ Large Platelets ___ Red cells

ADVIA® 2120i Hematology System

7-5

Methods

Reticulocyte Method Exercise 1. Identify the cell populations of the Retic Scatter ABS Cytogram.

___ Mature RBC’s ___ Coincidence events ___ Low absorption retics ___ Platelets ___ Medium absorption retics ___ High absorption retics

7-6

ADVIA® 2120i Hematology System

Methods

Basophil / Lobularity Method Exercise 1. Label the areas of the Baso cytogram. ___ MN (Lymphocyte and Monocyte nuclei) ___ PMN (Neutrophil and Eosinophil nuclei) ___ Basophil ___ Baso Suspect ___ Blast nuclei ___ Saturation ___ Noise

ADVIA® 2120i Hematology System

7-7

Methods

Peroxidase Method Exercise 1. Identify the areas of the Perox cytogram. ___ Neutrophils ___ Eosinophils ___ Monocytes ___ Lymphocytes and Basophils ___ Large Unstained Cells (LUCs) ___ Platelet clumps ___ Noise ___ nRBC’s

7-8

ADVIA® 2120i Hematology System

Methods

ADVIA® 2120i Hematology System

7-9

Quality Control II

8 Quality Control II

ADVIA® 2120i Hematology System

8-1

Quality Control Il

Quality Control II Resources •

ADVIA 2120i Hematology System Quick Reference Guide

•

ADVIA 2120/2120i Hematology Systems Operator’s Guide

Objectives After completing this exercise, you will be able to:

8-2

•

Demonstrate how to import a new lot of QC data

•

Interpret QC data

•

Demonstrate printing and exporting of a QC report

ADVIA® 2120i Hematology System

Quality Control II

Importing New Lot QC 1. Select Customize > System Setup (or Analyzer Setup) > Tools Modify > Control Dictionary. 2. Insert the mini CD into the computer. Note: It is possible to use the barcoded sheet that is enclosed in with each level of control and only import specific parameters. Scan the lot number barcode located in the upper right hand corner first, followed by the rest of the parameters. Proceed to Step 3.

3. Select Import

4. A list of controls appears. Select the first control to import by clicking on the control name, and then click OK.

ADVIA® 2120i Hematology System

8-3

Quality Control Il

5. If a control file already exists with this name (in this case, CDR Abnormal1), this window appears. Click on Create.

6. Enter a code name for the control. Refer to examples of code name below Note: Code names can be up to 6 characters and must be unique from lot to lot. 7. A Code Name can be a combination of control level, lot number and expiration date. Examples of Code Names: JulLow JulN JulHi or 1045L, 2045N, 3045H

8. Select OK

8-4

ADVIA® 2120i Hematology System

Quality Control II

9. Place a check mark next to Test Panel in order to see the colors on the Sample Control Panel.

10. Select OK. 11. A list of controls that still need to be imported appears. Select the next control level and repeat steps 4-9.

12. After all the controls are imported, click Cancel to end importing.

13. Select Exit button on the lower right hand side to exit Tools Modify.

ADVIA® 2120i Hematology System

8-5

Quality Control Il

Managing Quality Control Data 1. View the Normal QC for your current lot in the table format by selecting Data Manager > QC. Circle the icon that will display QC in table format.

2. Circle the icon that allows operator to export QC data and print QC data.

Omit / Add a Comment to QC 1. In the Table Format, you have the ability to omit or disposition a QC result from calculations. Navigate to Data Manager > QC. Select the normal QC and omit the last QC run by double-clicking on the date and time. Select Omit/Delete and select OK.

2. A comment can also be added to a QC in table format. Select an abnormal control and add a comment by typing comment in box and select OK.

Printing and Exporting QC Report 1. You would like to print the monthly statistics for the Normal control of your current QC. Select the Printer Icon on the Toolbar. On the Print Selection screen select From and verify the current month is displayed. In the Selection: All Daily, select Daily Summary for Control. Select the Normal control and press OK.

2. After printing QC you would like to save or export the QC data to a USB. Place USB in drive and select Export to file.

8-6

ADVIA® 2120i Hematology System

Quality Control II

ADVIA® 2120i Hematology System

8-7

Scheduled Maintenance

9 Scheduled Maintenance

ADVIA® 2120i Hematology System

9-1

Scheduled Maintenance

Scheduled Maintenance Resources •

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

9-2

•

Perform turning off the system

•

Perform wipe the outside of shear valve maintenance

•

Perform automatic hydraulic pathways maintenance

•

Perform clean Autosampler centering collar maintenance

•

Perform semi-automatic vent line wash

•

Perform replacement of RBC/Baso and Perox sheath filters

•

Perform clean the air-circulation filter maintenance

•

Record maintenance in the Service Log

ADVIA® 2120i Hematology System

Scheduled Maintenance

Scheduled Maintenance Use the ADVIA 2120i Hematology System Quick Reference Guide to perform the scheduled maintenance.

Weekly Maintenance •

Turn off the system

•

Wipe the outside of shear valve

•

Automatic Hydraulic Pathways Wash

•

Inspect Autosampler Centering Collar, clean if necessary

Two Weeks Maintenance •

Clean Autosampler Centering Collar

Monthly Maintenance •

Semi-automatic Vent Line Wash

Two Months Maintenance •

Replace RBC/Baso Sheath Filter and Perox Sheath Filter

Six Months Maintenance •

Clean air-circulation filter

Important: In addition to these scheduled procedures, periodic inspections of the UFC pathways, vacuum shuttle, and reaction chambers are essential. If you find buildup or dirt in any of the lines or chambers, clean the line or chamber in question.

Document Maintenance Performed in the Service Log Use the ADVIA 2120i Hematology System Quick Reference Guide to document all scheduled maintenance performed.

ADVIA® 2120i Hematology System

9-3

Scheduled Maintenance

9-4

ADVIA® 2120i Hematology System

Gains

10 Gains

ADVIA® 2120i Hematology System

10-1

Gains

Gains Resources •

ADVIA 2120/2120i Hematology Systems Operator’s Guide

•

ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

10-2

•

Identify when to adjust gains.

•

Identify what to check before adjusting gains.

•

Review the gains adjustment process using the Gains Wizard.

ADVIA® 2120i Hematology System

Gains

Identify When to Adjust Gains Gain adjustment is performed on an as-needed basis and in each of the following cases: •

On installation

•

If there is a significant shift in control values after:

•

o

Replacing a critical hydraulic or optical component

o

Installing reagents with a different lot number

o

When indicated by quality control data, or frequent false positive or false negative morphology flags

When verifying that the optical system is functioning properly before calibration

Identify What to Check before Adjusting Gains Perform the following before adjusting gains: 1. Visually inspect the hydraulics during operation to ensure that they function properly. 2. Check pressure and vacuum readings at Analyzer Status tab of the Utilities menu. 3. Perform the weekly maintenance.

Scenario: It has been 6 months since the last calibration was performed on the instrument. The regulatory agency College of American Pathologists (CAP) requires calibration of the hematology analyzer every 6 months. The operator needs to verify that the optical system is functioning properly and decides to perform the RBC Gains Adjustment. The operator has already performed the following: 1. Performed reagent check. 2. Checked the vacuum and pressure readings. 3. Observed shuttling. 4. Performed the weekly maintenance.

ADVIA® 2120i Hematology System

10-3

Gains

Review the RBC Gains Adjustment Using the Gains Wizard Analyzer Mode: Ready to Run Material Required: ADVIA 120 / 2120 / 2120i OPTIpoint™ •

Unopened stability: vial expiration date, when stored between 2-8°C

•

Opened stability – one week, when stored between 2-8°C

•

Allow OPTIpoint to reach room temperature

•

Vortex vigorously for 30-60 seconds

1. Select Procedures > Adjust Gains > Gain Wizard 2. Enter password and select OK (if required). 3. Select RBC / RETIC. The number of aspirations will default to 3. 4. Select Next 5. Select Next 6. Scan the OPTIpoint package insert, beginning with the lot number. Select Import Barcode to populate fields. 7. Select Next 8. On the Run / Data Review screen, process 3 aspirations of OPTIpoint through the manual open-tube sampler (MOTS). 9. After all aspirations are complete evaluate data on Run/Data Review screen. A red check mark in the Apply column will display on each row of data included in the statistical analysis; to omit data, deselect the red checkmark. Note: To run additional aspirations, select Run More and follow on screen instructions. 10. Select Next and review information on the Gain Acceptance screen. If status is Passed, select Accept Gains 11. Before final gain acceptance, a final verification is required. Select Ok and perform the required verification run. Process 3 aspirations of OPTIpoint through the manual open-tube sampler (MOTS). 12. After all verification run aspirations are complete, review Verification Run: Run/Data Review data. A red check mark in the Apply column will display on each row of data included in the statistical analysis; to omit data, deselect the red checkmark. 13. For final acceptance, select Next 14. Review information on the Gain Acceptance screen. If status is Passed, select Finish

10-4

ADVIA® 2120i Hematology System

Gains

15. Select Gain Factors Log to view and print gain factors. 16. Select Exit to close.

Gain Acceptance Criteria Number of Points

Flatness

Factor Range

RBC/Retic

3

n/a

20 - 255

Perox

8 - 25

≤ 3.2

20 - 255

Baso

5 - 25

≤ 2.5

20 - 255

ADVIA® 2120i Hematology System

10-5

Calibration

11 Calibration

ADVIA® 2120i Hematology System

11-1

Calibration

Calibration Resources •

ADVIA 2120i Hematology System Quick Reference Guide

•

ADVIA 2120i Hematology System Calibration Online Training

Objectives After completing this exercise, you will be able to:

11-2

•

Identify when to calibrate

•

Identify what to check before calibrating

•

Review the calibration process using the Calibration Wizard

ADVIA® 2120i Hematology System

Calibration

Calibration Overview When to calibrate •

On installation

•

If there is a significant shift in control values after: o

Replacing a critical hydraulic or optical component

o

Installing reagents with a different lot number

•

Any time commercial control products and/or moving averages are out of range and you have verified that the out-of-control condition is not instrument related

•

At periodic time intervals determined by laboratory regulations

What to check before calibrating 1. Verify that there is sufficient reagent for the calibration. Do not change the reagent lot number during the calibration. 2. Visually inspect the hydraulics during the operation to ensure that they function properly. 3. Check pressure and vacuum readings at the Analyzer Status tab of the Utilities menu. 4. Perform the weekly maintenance. 5. Verify that the optical system is functioning properly. Note: Do not calibrate unless the gain and alignment of all the optics channels have been verified.

Materials required for calibration 1. ADVIA SETpoint™ Calibrator and/or 1 whole blood sample to calibrate all parameters except for the %RETIC. 2. Include 5 whole blood samples if you want to calibrate the %RETIC. %Retic calibration is only performed at laboratories using a manual counting method other than those recommended by NCCLS or ICSH, or laboratories using certain flow cytometric methods. These laboratories could observe a significant bias when comparing to the ADVIA 120/2120/2120i Hematology System.

ADVIA® 2120i Hematology System

11-3

Calibration

Calibration Wizard To access Calibration Wizard, go to ADVIA 2120i Calibration Online Training: Using the Calibration Wizard. 1. Which sampler type is selected by default in the Calibration Definition screen?

2.

Review the Material Required screen. a. List the two materials required for calibration when calibrating all parameters with Retic. b. How do you prepare and handle your calibration materials?

3. Select Next to proceed to the Calibration Reference Data screen.

Review and Accept Calibration Data 1. Calibration Data Review screen

a. Why is it important to print the data before accepting calibration?

b. If a parameter failed, how are data points omitted?

c. What is the minimum number of data points required for Passed Status? 2. Select the back icon to Access the Calibration Acceptance screen. What is your calibration status?

11-4

ADVIA® 2120i Hematology System

Calibration

Locate and Print Calibration Factor Log 1. Go to your instrument and navigate to Calibration screen. Press Cal Factor to see current and previous Cal Factors. 2. After accepting the calibration, what should you run to verify system performance?

ADVIA® 2120i Hematology System

11-5

Troubleshooting

12 Troubleshooting

ADVIA® 2120i Hematology System

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Troubleshooting

Troubleshooting Resources •

ADVIA 2120/2120i Hematology Systems Operator’s Guide

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ADVIA 2120i Hematology System Quick Reference Guide

Objectives After completing this exercise, you will be able to:

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Utilize the Operator’s Guide to locate morphology and sample/system flags

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Identify troubleshooting basics

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Perform shear valve cleaning

ADVIA® 2120i Hematology System

Troubleshooting

Troubleshooting Basics Isolate the Problem •

Observation: leaks, shuttling, bubbles, cytograms, and histograms

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Startup Screen: reagent and background counts

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Analyzer Status: pressures, vacuum, temperature, light source intensity

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Message Log: view past messages for repeated errors

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QC: what individual test parameters are out of range?

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Flags o

Sample/system flags are codes displayed in the Review/Edit tab and the Run Screen. These codes are associated with a specific test parameter marked by an asterisk. Isolated instances of flags are usually sample related. However, multiple occurrences, especially for consecutive samples, can indicate an analyzer problem.

o

Morphology flags are plus signs (+) displayed in the Review/Edit tab and the Run Screen. These flags, one to three plus signs, alert the operator to possible cellular conditions that may require additional laboratory attention, such as preparing a slide for microscopic examination.

o

System messages are displayed on the status lines on the PC monitor. Along with the messages, color-coded icons indicate the severity level of the message.

General Troubleshooting Steps 1. Verify the following •

Reagent volume

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Reagent delivery

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Reagent in the correct position and straw is submerged in reagent

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All fittings between reagent container and reagent diaphragm pump are connected

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Prime reagent lines and observe for air bubbles. Air bubbles present may indicate faulty reagent straw; replace straw

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Excessive bubbles in pathways may indicate a faulty reagent pump. Contact Siemens Service personnel

2. Verify Sheath Reagent (ADVIA 120 / 2120 / 2120i Sheath/Rinse or Perox Sheath) delivery by checking sheath filter is 90% full and free of air bubbles. If bubbles are present, check filter for cracks or leaks in Luer fittings. Replace filter if needed taking care not to over-tighten Luer fitting.

ADVIA® 2120i Hematology System

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Troubleshooting

System Flags Troubleshooting Normal Flow Rates • Right side of UFC:

IFR Flags: BASOIFR, RBCIFR, RETICIFR • Left side of UFC:

IFR Flag: PXIFR • Top part of UFC:

IFR Flag: HGBIFR

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ADVIA® 2120i Hematology System

Troubleshooting

Irregular Flow Rate Examples Poor Sheath delivery

Poor sample delivery

Air in sample stream

Improper syringe plunger maintenance

Air in Hemoglobin reagent line

Refer to the ADVIA® 2120i Hematology System Quick Reference Guide: System Flags Troubleshooting Chart for troubleshooting IFR flags.

ADVIA® 2120i Hematology System

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Troubleshooting

Clean the Shear Valve 1. Analyzer mode: Off Important: Place paper towels directly under the shear valve to prevent fluid from dripping down into the analyzer. 2. Remove the knurled nut by turning counter-clockwise (1). 3. Remove the compression spring (2). 4. Remove the rotor (3). 5. Separate and remove shear face (4) by gently rotating front shear face. Caution: Do not loosen or remove with sharp object

6. Place the front shear face in 6% sodium hypochlorite solution and soak ten minutes. Rinse with DI water. 7. Rinse the rear shear face using a wash bottle filled with distilled water. Caution: Do not use paper towel, gauze or cotton swabs on shear faces 8. Reassemble the shear valve with the faces wet. Verify the black line on the front face aligns with the black line and A on back face. Smaller loops are at 9 and 11 o’clock and the large loop is at 5 o’clock. 9. Install the rotor by installing the drive pin in the hole on the right side of the front face. 10. Replace the spring and knurled nut. 11. Hand tighten nut. 12. Turn analyzer power on and verify Background Counts. 13. Run a whole blood primer and QC as per laboratory policy.

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ADVIA® 2120i Hematology System

Troubleshooting

ADVIA® 2120i Hematology System

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