IMMULITE 2000® XPi System Onsite · 2020. 10. 21. · IMMULITE 2000 XPi System 1-3 IMMULITE 2000 XPi System Course Validation Checklist The student places a checkmark beside the

IMMULITE 2000® XPi System

OnsiteTraining Workbook

IMMULITE 2000 XPi System T 03010.003 Effective Date: 08/17/20

Siemens Healthineers

IMMULITE® 2000 XPi System

Onsite Training Workbook

ii IMMULITE 2000 XPi System

IMMULITE 2000 XPi System iii

Table of Contents

1: Welcome

2: System Components

3: Software Overview

4: Daily Maintenance

5: Kit Entry and Adjustment

6: Quality Control

7: Sample Processing

8: Validating Adjustments

9: Maintenance

10: Troubleshooting

11: Allergy

iv IMMULITE 2000 XPi System

Welcome

IMMULITE 2000 XPi System 1-1

1 Welcome

Welcome to TrainingSiemens Healthineers Training would like to welcome you to training on theIMMULITE® 2000 XPi System.

This course is designed to teach you the skills needed to train other operators of theIMMULITE 2000 XPi System. Our staff welcomes the opportunity to present thistraining program to you.

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

Welcome

1-2 IMMULITE 2000 XPi System

Course ObjectivesThe purpose of this Secondary Operator Training Guide is to provide you with thematerials to assist in training other operators on:

· Identify System Components and their functions

· Navigate the Home screen, Bead and Reagent screen and the Help Screen

· Scan Reagent kit bar codes

· Load bead packs and reagent wedges

· Run Adjustors

· Run controls

· Order and run patient samples

· Discuss the Review Screen features

· Schedule and initiate AutoStart

· Enter control definitions

· Create a QC panel

· Validate Adjustments

· Perform daily, weekly, monthly and quarterly maintenance

· Discuss common errors

· Discuss allergy assays and run (optional objective: based on class needs)

Welcome

IMMULITE 2000 XPi System 1-3

IMMULITE 2000 XPi System

Course Validation ChecklistThe student places a checkmark beside the competency when it is completed. When allcompetencies are checked, the instructor and operator sign and date below as a record ofcompletion.

Topics Competencies Completed

System Components Identify the system components and itsfunction

Software Overview Navigate the Home Screen

Daily Maintenance Perform daily maintenance procedures

Kit Entry andAdjustment

Scan new kits into database

Load reagent wedges and bead packs

Run adjustors

Quality Control Run barcoded and non-barcoded controls

Enter control definitions

Create a QC panel

Create and schedule a QC List

Sample processing Order barcoded and non-barcoded patientsamples

Run STAT samples

Order dilutions

Run microsamples and tube top cup samples

ValidatingAdjustments

Validate adjustments

Maintenance Perform weekly, monthly and quarterlymaintenance

Troubleshooting Discuss common operator errors and helpscreen

Allergy Identify and load the allergy kit components(optional objective based on customer need)

Run allergy adjustors and controls (optionalobjective based on customer need)

Welcome

1-4 IMMULITE 2000 XPi System

Instructor: _____________________________________________

Participant: _____________________________________________

Date: _________________________________________________

What was most helpful to you during this program?

_____________________________________________________________

_____________________________________________________________

How can we make this program more meaningful to you?

_____________________________________________________________

_____________________________________________________________

System Components

IMMULITE 2000 XPi Immunoassay System 2-1

2 System Components

System Components

2-2 IMMULITE 2000 XPi Immunoassay System

System Components

Resources· IMMULITE 2000® XPi System Operator’s Guide

· Online Help

· System Overview Online Training Course

ObjectivesUpon completion of this exercise you will be able to:

· Identify system components.

· Identify the function of the components.

System Components


Exercise Activity and Questions

System Components1. Identify the components in the image below. Write the corresponding letter

next to the name of the component.

a. Reagent Carousel Door d. Rack Loader

b. DRD Priming / Substrate Reservoir Door e. Sample Pipettor Door

c. Monitor Arm f. Bead Carousel Door

System Components


2. Match the following components to their locations on the instrument. Write thecorresponding letter next to the name of the component.

a. Reagent Carousel

b. Sample and Reagent Pumps (DRDs)

c. Sample and Reagent Pipettors

d. Incubator

e. Sample Carousel

f. Dilution Well

g. Bead Carousel

System Components


3. Match the name of the component with its function. Write the letter next to thename of the component.

___ DRD Priming/SubstrateReservoir Door

a. Used to load and remove sample rackswithout pausing the system.

___ Reagent Carousel b. Used to view the DRDs during primingand to load substrate onto the system.

___ Dilution Well c. Mixes specified quantities ofspecimen, diluent and water.

___ Pipettors d. Consists of the incubator, washstation, luminometer and PMT.

___ Rack Loader e. Refrigerated compartment with 24positions.

___ Tube Processor f. Dispenses sample and reagent intoreaction tubes.

System Components


ConsumablesIdentify the consumables in the image below. Write the name of the componentnext to the corresponding letter.

h. DI Water

i. Substrate Bottle

j. Probe Wash

k. Liquid Waste

l. Solid Waste

Software Overview


3 Software Overview

Software Overview


Software Overview

Resources· IMMULITE® 2000 XPi, System Operator’s Guide

· Online Help

· System Overview Online Training Course

ObjectiveUpon completion of this exercise you will be able to navigate the Home screen.

Software Overview



Home ScreenWrite the corresponding letter next to the matching area of the Home screen.

____ Horizontal Toolbar

____ Consumables Indicators

____ Reagent Icons

____ Sample Rack Icons

____ Bead Icons

____ Instrument / Results View

____ Vertical Toolbar

G

C

E

F

B

D

A

Software Overview


Daily Maintenance


4 Daily Maintenance

Daily Maintenance


Daily Maintenance

Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide

· Online Help

· Daily Maintenance Online Training Course


· Log off the software and restart the computer.

· Perform daily probe cleaning.

· Check and replenish consumables.

· Prime the instrument.

· Schedule and initiate an Autostart

Daily Maintenance


Daily Maintenance

Maintenance Procedure Purpose

Logging off IMMULITE 2000 XPisystem software*

Allows backup to be performed, which cleansup the results database, removes old recordsand allows new data to be stored.

Restart Windows* Allow the Windows operating system to copyprogram files and protects the Windowssoftware in case of a power failure.

Daily Probe Cleaning* Keeps probes free of lipid/protein buildupthat can lead to imprecision.

Check Consumables Assures consumables supply to preventoperation interruptions.

Prime Sample and ReagentPipettors*

Assures any air in the system is purged toprevent pipetting imprecision by priming theDRDs at least 15 times or until they are freeof air bubbles.

Prime Water Probe* Assures all air is purged to prevent pipettingimprecision when the probe supplies waterfor high-speed washing.

Prime Substrate Probe* Assures all air is purged to prevent pipettingimprecision when the probe suppliessubstrate to reaction tubes after washing.

*Included in AutoStart.

Daily Maintenance



Logging Off and Restarting the Computer1. If the software is not already logged off, perform log off.

2. Restart the Computer.

Daily Probe Cleaning

Perform daily probe cleaning from Diagnostics.1. Which button would an operator select in order to perform daily probe

cleaning?

2. What consumable items are required to perform daily probe cleaning?

Checking ConsumablesCheck consumables on the instrument and replenish as needed.

1. Explain what can happen if the liquid waste container is improperly connected.Explain the proper way to empty the liquid waste.

2. How much water needs to be added to 1 bottle of probe wash?

3. When the solid waste bin is placed back on the system, where should the tubedeflector be?

Daily Maintenance


Priming the InstrumentInitialize the software and prime the DRDs, water probe, and substrate probe.

1. Why is it important to open the cover during priming?

2. Explain some causes for air in the lines during priming.

3. Explain what could happen if precipitate is left at the tip of the substrate nozzle.

Daily Maintenance


Exercise Activity and Questionsa. From the Menu screen, select the Auto Start Configuration button.

a. How would you configure the system to run Auto Start everyday at6 am?

_______________________________________________________

b. How would you configure the system to run automatic substrate dispense?

_______________________________________________________

Daily Maintenance


b. Load a barcoded tube with 1.5 ml of probe cleaning solution onto the system.

Does the solution need to be loaded into a particular position on the samplecarousel?

_______________________________________________________

c. From the Menu screen, select Run Autostart.

What mode must the system be in before initiating Auto Start?

_______________________________________________________

d. Observe the screen as Auto Start begins.

Daily Maintenance


Kit Entry and Adjustment


5 Kit Entry and Adjustment



Kit Entry and Adjustment Practical Exercise

Resources· IMMULITE® 2000, IMMULITE® 2000 XPi, IMMULITE® 2500 Immunoassay Systems

Operator’s Guide

· Online Help

· Adjustment Online Training Course


· Scan kit bar codes.

· Load the bead packs and reagent wedges.

· Run adjustors.



Exercise and Activity Questions

Kit Entry

1. Use the handheld scanner to enter the kits into the IMMULITE 2000 XPidatabase by scanning the 2D barcode on the kit box.

How many kit lots can be saved for each test?

_______________________________________________________

2. Load the reagent wedges and bead packs onto the system.

a. What is the proper way to load a bead pack on the instrument?

______________________________________________________

b. When loading a reagent wedge, why is it important to check the top of thewedge and glide?



_______________________________________________________

c. When will the Reagent and Bead screens be updated to reflect thecomponents loaded on the instrument?

_______________________________________________________

3. Select the Run button.



Bead and Reagent ScreenSelect one of the reagent or bead icons on the Home screen to access the Reagentor Bead screen.

· Which status is indicated by each color on the Reagent and Bead screens?

Grey:

White:

Light Brown:

Red:



Ordering Adjustors

1. Label sample tubes with the low and high adjustor barcode labels providedwith the respective kits. Transfer the adjustor material into the appropriatetubes. Load the tubes onto the sample carousel.

How can you determine the amount of sample that is required to run theadjustors?

____________________________________________________

2. Order the adjustors for the respective kits.

What information needs to be entered on the Worklist screen to order theadjustor tests?

_______________________________________________________

3. Select the Display/Edit button. Select Update.



Display/Edit Screen



Status Definitions

Time Time remaining for the test to be completed.

Waiting Sample is onboard the instrument but the test has not started.

In-Queue Test requested is close to being processed.

No Sample Sample for the requested test is not onboard the instrument.

Sample Error: Problem with sample tube, either not enough sample or clotdetected.

No Bead The bead pack is not onboard.

Bead Err Bead pack is empty or has an error

Reagent Err Reagent wedge is empty, has an error or is not onboard.

Allergen Err Allergen wedge is empty, has an error or is not onboard.

Diluent Err Diluent is empty, has an error or is not onboard.

Deactivated Valid components are onboard but the related kit lot is deactivated.

Quality Control


6 Quality Control

Quality Control


Quality Control: Practical Exercise


· Online Help

· Quality Control Online Training Course

ObjectiveUpon completion of this exercise you will be able to:

· Run barcoded and non-barcoded controls

· Enter Control definitions

· Create a QC panel

· Create and schedule a QC list

Quality Control



Ordering Controls

1. Label 3 sample tubes with the available control barcode labels, one for eachlevel. Transfer the appropriate control material into its corresponding sampletube. Place the 3 control tubes on the sample carousel.

2. Order the respective tests on each of the control levels.

What is the difference between ordering adjustors and controls?

_______________________________________________________

3. View the status of the control samples.

What is the status of control samples that were just ordered?

_______________________________________________________

Quality Control


Adding a Test to an Existing ControlEnter QC ranges for 2 specified Tests in the QC Data Entry screen. Enter the Meanand SD information provided in the control package insert.

4. What button is selected to fill in the low and high limits after the mean and SDare entered?

5. What message appears when the Save button is selected?

Quality Control


Creating a PanelCreate and name a panel for all assays. Use the Help system in the instrumentsoftware to find the procedure for creating a panel.

Running Non-barcoded Controls

Discuss Non-barcoded Controls

Running the Controls6. Run the three levels of quality control using your newly created QC panel.

7. Once all controls are in progress, select the Pause button.

Why does a message appear?

Sample Processing


7 Sample Processing

Sample Processing


Processing Patient Samples Practical Exercise

Resources· IMMULITE® 2000, IMMULITE® 2000 XPi, IMMULITE® 2500 Immunoassay Systems

Operator’s Guide

· Online Help

· Sample Processing Online Training Course


· Order barcoded and non-barcoded patient samples

· Run STAT samples.

· Order dilutions.

· Run microsamples and tube top cup samples.

· Access the Review screen.

Sample Processing


Microsample TubesMicrosample tubes are identified on the system by a permanent barcode labelattached to the reusable Microsample Tube Holder. A 10 x 50mm disposable sampletube is inserted into the holder. The dead volume for microsample tubes is 50 µl.

Tube Top Cups (Nested Cups)Tube top cups allow the operator an alternative way to run small volumes ofsample. Tube top cups must be placed in a dedicated tube top rack. The tube topracks are identified with a lower case letter on the rack barcode. The dead volumefor tube top cups is 100 µl.

Tube Top Cup / Nesting Cup

Primary Tube

Sample Processing



Running Barcoded Samples1. Load the following tubes onto the sample carousel:

· Barcoded patient samples

· Patient samples with tube top cups

· Barcoded microsample tubes

2. Select the Worklist button and then select Display/Edit.

a. What information appears on the screen for each sample?

_______________________________________________________

b. What happens if you select the Update button?

_______________________________________________________

c. When a sample has been pipetted, what is its status on the Display/Editscreen?

_______________________________________________________

3. Navigate the software to find a screen that identifies the positions ofmicrosample tubes and tube top cups on the sample carousel.

a. Can you tell which tubes are microsample tubes on the Display/Edit screen?

_______________________________________________________

b. How can you tell the difference between standard sample racks and tubetop sample racks in the software?

Sample Processing


Manually Ordering STATs and Dilutions1. Load the tubes on the sample carousel.

Accession # Test

1. 3 Reps of TT4

2. HCG STAT

3. HCG x 5 Dilution

2. Order the tests listed in the above table.

_______________________________________________________

_______________________________________________________

3. Add a different test to one of the samples.

List 2 ways to add a test to a sample that is currently in progress.

_______________________________________________________

Sample Processing


Running Non-barcoded Patient Samples

Ordering Patient Tests

1. Load 2 non-barcoded tubes on the sample carousel.

Position Accession # Name Test

2. Navigate to the Sample Tubes in Racks screen.

How can you tell where the non-barcoded tubes are located on the instrument?

_______________________________________________________

3. Order the tests listed in the above table. Refer to the Help system in theinstrument software to find the procedure for running non-barcoded tubes.

Sample Processing


Accessing Review Screen

Review Screen

Select the Review button.

1. Select the Time button to open the Select Time Method window.

What options are available in this window?

_______________________________________________________

2. Select to view all results.

a. How many results appear on the screen at a time?

_______________________________________________________

b. Which buttons are used to scroll through different results?

_______________________________________________________

Sample Processing


Validating Adjustments


8 Validating Adjustments



Validating Adjustments Practical Exercise


· Online Help

· Adjustment Online Training Course

ObjectiveUpon completion of this exercise you will be able to validate adjustments.



Adjustment Report

· A - Instrument Slope Range:

o ±20% range of the Average Instrument Slope.o Used to evaluate the slope of an initial adjustment.

· B – 10% of the Previous Slope

o ±10% range of the of the previous successful adjustment slope forthat assay.

o Used to evaluate the slope of a readjustment.

· C – Assay Average Slope: The average of all successful adjustmentslopes for the assay.

· D – Intercept Guideline: The absolute value of the adjustmentintercept should be less than or equal to the Intercept Guideline.

Adjustment GuidelinesAlthough the adjustment printout states “Adjustment Complete”, theadjustment needs to be validated to ensure that patients can be reported.Three guidelines have been established to help you judge whether theadjustment is successful. The guidelines are listed below in order ofimportance:1. Evaluate control values run immediately following the adjustment.2. Evaluate the slope of the adjustment.3. Evaluate the intercept of the adjustment.



Exercise and Activity QuestionsIn this exercise, you will evaluate examples of adjustment and quality controlresults. Each example consists of an adjustment report followed by theresults of the controls that were run after the adjustors.For each set of results, use the three adjustment validation guidelines todetermine if the adjustment is valid.For the adjustments that are not valid, evaluate the data to determinepossible causes for the failed adjustment.



AdjustmentLab Name: Instrument ID B0070

Instrument S/N B0070

Test Code E2 Kit Lot 160 Agn Lot

Slope Intercept0.81-1.32 N=18 684,089

1.011 N=4

Low Adjustor 17,160,770Test Code CPS Lot# Date Time

1st rep. E2 7,804 112 5/9/2006 11:04:03AM2nd rep. E2 8,161 112 5/9/2006 11:14:28AM3rd rep. E2 4,652,044 112 5/9/2006 11:14:28AM4th rep. E2 8,028,262 112 5/9/2006 11:14:46AM

Mean CPS= 3,174,068 CV= 123.094%

High Adjustor 2,224,029Test Code CPS Lot# Date Time

1st rep. E2 1,174,542 112 5/9/2006 11:15:04AM2nd rep. E2 1,771,632 112 5/9/2006 11:15:22AM3rd rep. E2 2,324,688 112 5/9/2006 11:15:40AM4th rep. E2 2,190,000 112 5/9/2006 11:15:58AM

Mean CPS= 1,865,216 CV= 27.727%

Adjustment was Not Successful CV of Low and High Adjustor not within limitReport Date5/9/2006

Lab/ISD - EX 1

Initial Adjustment

Instrument Slope Range: ±10% of Previous E2 Slope:

E2 Average Slope:

Intercept Guideline:



Page 1

Control

Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007

Date Time Test Lot Range CPS Result Units Z-Score5/9/2006 11:16:16AM E2 160 59-95 14,266,263 57 LOW pg/mL -2.17



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score5/9/2006 11:16:32AM E2 160 175-275 9,108,642 180 pg/mL -1.80



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score5/9/2006 11:16:50AM E2 160 895-1191 2,495,625 915 pg/mL -1.73





Test Code FT4 Kit Lot 375 Agn Lot

Slope 1.202 Intercept -97,3040.95-1.35 N=22 394,0321.077-1.3171.011 N=7


1st rep. FT4 14,929,612 121 7/4/2006 03:44:39PM2nd rep. FT4 14,962,759 121 7/4/2006 03:44:57PM3rd rep. FT4 14,872,716 121 7/4/2006 03:45:15PM4th rep. FT4 14,732,127 121 7/4/2006 03:45:34PM

Mean CPS= 14,874,304 CV= 0.685%


1st rep. FT4 2,671,826 121 7/4/2006 03:45:52PM2nd rep. FT4 2,819,654 121 7/4/2006 03:46:10PM3rd rep. FT4 2,835,021 121 7/4/2006 03:46:28PM4th rep. FT4 2,956,687 121 7/4/2006 03:46:46PM

Mean CPS= 2,820,797 CV= 4.137%

Adjustment CompleteReport Date7/4/2006

Lab/ISD - EX 2

Readjustment

Instrument Slope Range: ±10% of Previous FT2 Slope:

FT4 Average Slope:




Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score7/4/2006 4:02:01PM FT4 375 0.64-0.96 19,673,753 0.76 ng/dL -0.50



Page 1Control


Date Time Test Lot Range CPS Result Units Z-Score7/4/2006 04:02:01PM FT4 375 1.1-1.5 6,997,800 1.54 HIGH ng/dL 2.40



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score7/4/2006 04:02:20PM FT4 375 1.86-2.5 5,695,470 2.37 ng/dL 1.00





Test Code TSH Kit Lot 103 Agn Lot

Slope Intercept0.75-1.25 34 8,009

1.07 12

Low Adjustor 26,695Test Code CPS Lot# Date Time

1st rep. TSH 12,125 122 9/2/2006 10:11:27AM2nd rep. TSH 18,725 122 9/2/2006 10:11:45AM3rd rep. TSH 24,950 122 9/2/2006 10:16:16AM4th rep. TSH 28,649 122 9/2/2006 10:16:34AM

Mean CPS= 24,108 CV= 20.803% (Replicate #1 was omitted)


1st rep. TSH 2,048,579 122 9/2/2006 10:16:52AM2nd rep. TSH 2,067,411 122 9/2/2006 10:17:10AM3rd rep. TSH 2,098,227 122 9/2/2006 10:17:28AM4th rep. TSH 2,075,286 122 9/2/2006 10:17:46AM

Mean CPS= 2,072,376 CV= 0.992%

Adjustment was Not Successful CV of Low Adjustor not within limitReport Date9/2/2006

Lab/ISD - EX 3

Initial Adjustment

Instrument Slope Range: ±10% of Previous TSH Slope:

TSH Average Slope:




Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score9/2/2006 10:23:42AM TSH 103 0.21-0.31 112,614 0.188 LOW mIU/mL -2.88



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score9/2/2006 10:24:01AM TSH 103 2.9-3.7 1,728,375 2.9 mIU/mL -1.90



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score9/2/2006 10:24:09AM TSH 103 14.6-18.0 8,752,141 15.6 mIU/mL -0.81



AdjustmentLab Name: Lab/ISD - EX 4 Instrument ID B0003

Readjustment Instrument S/N B0003


Slope 1.6672 Intercept -48,584Instrument Slope Range: 0.86-1.35 N=16 Intercept Guideline: 391,401

±10% of Previous E2 Slope: 1.122-1.371E2 Average Slope: 1.21 N=3


1st rep. E2 6,160,110 110 9/5/2006 10:40:26AM2nd rep. E2 6,318,862 110 9/5/2006 10:40:44AM3rd rep. E2 6,452,826 110 9/5/2006 10:41:02AM4th rep. E2 6,484,995 110 9/5/2006 10:41:21AM

Mean CPS= 6,354,198 CV= 2.330%


1st rep. E2 658,588 110 9/5/2006 10:41:39AM2nd rep. E2 683,322 110 9/5/2006 10:41:57AM3rd rep. E2 691,301 110 9/5/2006 10:42:15AM4th rep. E2 665,017 110 9/5/2006 10:42:33AM

Mean CPS= 674,557 CV= 2.270%

Adjustment CompleteReportDate9/5/2006



Page 1

Control





Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score9/5/2006 10:43:27AM E2 162 895-1191 119,268 740 LOW pg/mL -4.09



AdjustmentLab Name: Lab/ISD - EX 5 Instrument ID B0003

Readjustment Instrument S/N B0003

Test Code RTH Kit Lot 149 Agn Lot

Slope 6737.222 Intercept-609,397,036

Instrument Slope Range: 0.97-1.35 N=18 Intercept Guideline: 9,187±10% of Previous RTH Slope: 0.99-1.22

RTH Average Slope: 1.051 N=3


1st rep. RTH 33,575 104 6/23/2006 07:00:09PM2nd rep. RTH 33,395 104 6/23/2006 07:00:27PM3rd rep. RTH 34,296 104 6/23/2006 07:00:45PM4th rep. RTH 32,194 104 6/23/2006 07:01:03PM

Mean CPS= 33,365 CV= 2.615%


1st rep. RTH 34,876 104 6/23/2006 07:01:21PM2nd rep. RTH 33,329 104 6/23/2006 07:01:39PM3rd rep. RTH 33,723 104 6/23/2006 07:01:57PM4th rep. RTH 34,513 104 6/23/2006 07:02:15PM

Mean CPS= 34,110 CV= 2.079%

Adjustment NOT successful. Exceeded rejection limits for slope.ReportDate6/23/2006



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/23/2006 07:02:33PM RTH 149 0.20-0.30 42,065 0.23 uIU/mL -0.83



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/23/2006 07:02:51PM RTH 149 2.9-3.7 5,555,500 3.5 uIU/mL 0.95



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/23/2006 07:02:51PM RTH 149 15.1-18.9 13,042,400 18.2 uIU/mL 1.3





Test Code TT4 Kit Lot 210 Agn Lot

Slope 1.0754 Intercept 763,6580.74-1.27 N=44 1,507,4830.959-1.17231.151 N=12


1st rep. TT4 12,484,097 110 3/30/2006 01:13:50PM2nd rep. TT4 13,197,066 110 3/30/2006 01:14:08PM3rd rep. TT4 13,428,364 110 3/30/2006 01:14:26PM4th rep. TT4 12,830,281 110 3/30/2006 01:14:44PM

Mean CPS= 12,984,952 CV= 3.195%


1st rep. TT4 34,578,833 110 3/30/2006 01:15:02PM2nd rep. TT4 31,720,853 110 3/30/2006 01:15:20PM3rd rep. TT4 34,901,255 110 3/30/2006 01:15:38PM4th rep. TT4 35,062,684 110 3/30/2006 01:15:56PM

Mean CPS= 34,065,906 CV= 4.627%


Lab/ISD - EX 6

Readjustment

Instrument Slope Range: ±10% of Previous TT4 Slope:

TT4 Average Slope:




Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score3/30/2006 01:59:55PM TT4 210 1.8-3.0 39,736,604 2.22 ug/dL -0.6



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score3/30/2006 02:00:14PM TT4 210 6.7-8.7 1,974,862 7.22 ug/dL -0.98



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score3/30/2006 2:00:32PM TT4 210 11.1-13.9 13,010,349 13.0 ug/dL 0.71






Slope Intercept0.804-1.21 N=31 391,578

1.057 N=5


1st rep. E2 12 102 11/1/2006 12:43:44PM2nd rep. E2 31 102 11/1/2006 12:43:08PM3rd rep. E2 22 102 11/1/2006 12:43:26PM4th rep. E2 31 102 11/1/2006 12:44:02PM

Mean CPS= 28 CV= 18.558% (Replicate #1 was omitted)


1st rep. E2 10 102 11/1/2006 12:44:20PM2nd rep. E2 31 102 11/1/2006 12:44:38PM3rd rep. E2 31 102 11/1/2006 12:44:56PM4th rep. E2 21 102 11/1/2006 12:45:14PM

Mean CPS= 21 CV= 27.824% (Replicate #1 was omitted)

Adjustment NOT successful. Both Low Adjustor and High Adjustor not within CV acceptable limits.Report Date11/1/2006

Lab/ISD - EX 7

Initial Adjustment

Instrument Slope Range: ±10% of Previous E2 Slope:

E2 Average Slope:




AdjustmentLab Name: Instrument ID C0091

Instrument S/N C0091

Test Code HCG Kit Lot 172 Agn Lot

Slope 1.0358 Intercept -1,6510.81-1.34 N=25 15,794

1.013 N=9


1st rep. HCG 51,123 118 6/10/2006 10:40:47AM2nd rep. HCG 52,741 118 6/10/2006 10:41:05AM3rd rep. HCG 53,259 118 6/10/2006 10:41:23AM4th rep. HCG 52,561 118 6/10/2006 10:41:41AM

Mean CPS= 52,421 CV= 1.745%


1st rep. HCG 9,916,199 118 6/10/2006 10:42:00AM2nd rep. HCG 9,129,972 118 6/10/2006 10:42:00AM3rd rep. HCG 9,326,851 118 6/10/2006 10:42:18AM4th rep. HCG 8,914,003 118 6/10/2006 10:42:37AM

Mean CPS= 9,321,756 CV= 4.620%


Lab/ISD - EX 8

Initial Adjustment

Instrument Slope Range: ±10% of Previous HCG Slope:

HCG Average Slope:




Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/10/2006 11:18:04AM HCG 172 8.5-12.3 237,781 9.34 mIU/mL -1.13



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/10/2006 11:18:22AM HCG 172 32-42 496,291 35 mIU/mL -0.77



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score6/10/2006 11:18:50AM HCG 172 355-451 5,081,153 405 mIU/mL 0.08



AdjustmentLab Name: Instrument ID C0091

Instrument S/N C0091

Test Code HCG Kit Lot 172 Agn Lot

Slope 1.1036 Intercept -21,3460.85-1.29 N=54 15,7930.934-1.1411.09 N=12


1st rep. HCG 70,259 118 8/10/2006 10:40:47AM2nd rep. HCG 71,172 118 8/10/2006 10:41:05AM3rd rep. HCG 74,572 118 8/10/2006 10:41:23AM4th rep. HCG 72,245 118 8/10/2006 10:41:41AM

Mean CPS= 72,062 CV= 2.581%


1st rep. HCG 9,420,198 118 8/10/2006 10:42:00AM2nd rep. HCG 9,429,972 118 8/10/2006 10:42:00AM3rd rep. HCG 9,326,851 118 8/10/2006 10:42:18AM4th rep. HCG 9,014,003 118 8/10/2006 10:42:37AM

Mean CPS= 9,297,756 CV= 2.095%


Lab/ISD - EX 9

Readjustment

Instrument Slope Range: ±10% of Previous HCG Slope:

HCG Average Slope:




Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score8/10/2006 11:18:04AM HCG 172 8.5-12.3 257,781 9.67 mIU/mL -0.78



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score8/10/2006 11:18:22AM HCG 172 32-42 656,291 39 mIU/mL 0.77



Page 1

Control


Date Time Test Lot Range CPS Result Units Z-Score8/10/2006 11:18:50AM HCG 172 355-451 4,081,153 399 mIU/mL -0.17



Adjustment

Lab Name: Instrument ID B0065


Test Code CVG Kit Lot 102 Agn Lot

Adj Index 0.9563

0.9600.948 N=5

Adjustor 1,350,605Test Code CPS Lot# Date Time

1st rep. CVG 1,339,840 105 8/13/2006 11:00:41AM2nd rep. CVG 1,289,856 105 8/13/2006 11:00:59AM3rd rep. CVG 1,264,573 105 8/13/2006 11:01:17AM4th rep. CVG 1,274,902 105 8/13/2006 11:01:35AM

Mean CPS = 1,292,293 CV= 2.581%


Lab/ISD - EX 10

Initial Adjustment

Previous CVG Index:CVG Average Index:



Page 1

Control

Control Name: CVGNEGControl Lot: 010Control Level: 1Expiration Date: 10/31/2007

Date Time Test Lot Range CPS Result Units Z-Score8/13/2006 11:18:04AM CVG 102 0.0-0.4 210,334 0.16 -0.4



Page 1

Control

Control Name: CVGPOSControl Lot: 010Control Level: 2Expiration Date: 10/31/2007

Date Time Test Lot Range CPS Result Units Z-Score8/13/2006 11:18:30AM CVG 102 2.3-3.5 3,777,699 2.92 0.067

Weekly, Monthly, and Quarterly Maintenance


9 Weekly, Monthly, and Quarterly Maintenance



Weekly, Monthly, Quarterly MaintenancePractical Exercise

Resources· IMMULITE® 2000, IMMULITE® 2000 XPi, IMMULITE® 2500 Immunoassay

Systems Operator’s Guide

· Online Help

· Required Maintenance Online Training Course

ObjectiveUpon completion of this exercise you will be able to:

· Perform weekly maintenance.

· Perform monthly maintenance.

· Perform quarterly maintenance.



Weekly Maintenance


Waste tube cleaning Keeping this tubing clean prevents bacterialgrowth. If this tubing clogs, it may lead towaste backing up into the wash/spinstations.

Sample probe angle check Checks the integrity of the sample probe.Damage may lead to sample carryover.

Monthly Maintenance


Decontamination of bottles andlines

Keeps bottles and fluidics lines free ofmicrobial growth.

Clot transducer decontamination Keeps the clot transducer free of microbialgrowth. Use only 0.1M solution of NaOHfor this procedure.

Reagent probe dispense angle Checks the integrity of the reagent probe.

Cleaning the fan filter Allows for proper cooling of the computersand hard drives. If the temperatures aretoo high for these compartments , they willstop working.

Water test PM Ensures system water is free of alkalinephosphate contamination.

Quarterly Maintenance


Replacing the CO2 scrubber Maintains the integrity of the substrate.The CO2 scrubber removes CO2 from thesubstrate. CO2 destroys the substrate.

Weekly, Monthly, Quarterly Maintenance


Serial #: ________________

Month: _______________________

Daily Maintenance: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Check/Fill Reaction TubeHopper

Check/Fill Water

Check/Fill Probe Wash

Check/Fill Substrate

Check/Empty Waste

Prime Substrate Probe (if notconfigured to automaticallydispense)

Perform AutoStart

Operator initials:

Weekly Maintenance: week 1 Week 2 week 3 week 4 week 5

Clean Waste Tube (liquid)

Check Sample Probe DispenseAngle

Operator initials:

Supervisor's Signature_____________________________________

IMMULITE 2000 XPiDaily & Weekly Maintenance Record



Serial #_______________

Monthly and Quarterly maintenance for the year beginning ___________ , ______ to the year ending ___________ , ______

month year Month year

Monthly Maintenance List JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Clean Water Bottle and Probe Wash bottle

Decontaminate the Lines

Transducer Decontamination

Reagent Probe Angle

Clean the Fan Filter

Water Test PM

Operator Initials

Supervisor Initials

Quarterly Maintenance ListReplacement

Date 1Replacement

Date 2Replacement

Date 3Replacement

Date 4Replace CO2 Scrubber

Operator Initials

Supervisor Initials

IMMULITE 2000 XPiMonthly & Quarterly Maintenance Record




Weekly Maintenance

Waste Tube Cleaning

Perform Waste Tube Cleaning.

What consumable items are required to perform waste tube cleaning?

_________________________________________________

Sample Probe Dispense Angle Check

Check the Sample Probe Dispense Angle.

Why is it necessary to check sample probe dispense angle?

_________________________________________________

Monthly Maintenance

Decontaminating the Lines

Initiate Decontamination – 2000.

1. When running the decontamination diagnostic, how do the prompts on thescreen change when the water probe is moved as part of the first prompt?

__________________________________________________________

2. What materials should you use to perform decontamination?

__________________________________________________________

Clot Transducer Decontamination

Initiate Clot Transducer Decontamination maintenance procedure.

What materials do you need to clean the clot detector?

_____________________________________________________________

Reagent Probe Angle

Check the Reagent Probe Angle.



Cleaning the Fan Filter

Clean the Fan Filter.

1. Where is the fan filter located?

_________________________________________________

2. How should the fan filter be cleaned?

_________________________________________________

Water Test PM

Perform Water Test PM

1. Why is it important to perform the water test PM after decontamination?

_________________________________________________________

2. What are you checking when performing water test PM?

_________________________________________________________

Quarterly Maintenance

CO2 Scrubber

Replace the CO2 scrubber

Does the instrument monitor the onboard stability of the CO2 scrubber?

_________________________________________________________

Troubleshooting


10 Troubleshooting

Troubleshooting


Sample and Instrument TroubleshootingPractical Exercise


· Online Help

· Troubleshooting Online Training Course

ObjectiveUpon completion of this exercise you will be able to discuss commonoperators errors and the help screen

Troubleshooting


Clot Troubleshooting

Case 1The instrument detects a clot in the sample tube.

Troubleshooting


Case 2The instrument detects a hanging clot.

Troubleshooting


Help Screen1. Access the Help screen.

2. Locate the procedure for adding adjustors.Which steps did you take to locate this procedure?

3. Search for help on the error message 537: Tip Jam Reagent Pipettor.What steps did you take to locate help for this error?

Allergy


11 Allergy

Allergy


Allergy Practical Exercise


· Online Help

· Allergy Online Training Course

ObjectiveUpon completion of this exercise you will be able to discuss the allergy kitcomponents.

Optional Objective: Based on class participant needs

· Identify and load the allergy kit components

· Run allergy adjustors and controls.

Allergy



Identify and Load Allergy Kit Components1. Open the allergy kit box and inspect the components.

List the components found in the allergy kit box.

______________________________________________________

2. Locate the allergy kit barcode on the inside flap of the kit box. Scan the allergykit barcode.

a. When should the allergy kit barcode be scanned?

______________________________________________________

b. When the barcode is scanned successfully, which screen appears?

______________________________________________________

3. Load the universal reagent wedge and universal bead pack onto the system.

What needs to be done to prepare a universal reagent wedge before it is loadedon the system?

______________________________________________________

Allergy


Run Allergy Adjustors and Controls1. Locate the adjustor allergen vials and the control allergen vials in the kit box.

Remove the allergen vial barcode from one of the adjustor allergen vials andone of the control allergen vials. Scan the allergen vial barcodes into the system.

a. When do allergen vials need to be scanned into the system?

______________________________________________________

b. When the allergen vial is scanned successfully, which screen appears?

______________________________________________________

2. Replace the standard caps on the allergen vials with septum caps.

Why is it recommended to put septum caps on the allergen vials?

______________________________________________________

3. Load the adjustor allergen vial and control allergen vial into an allergen wedge.Scan the allergen wedge into the system. Load the allergen wedge onto thereagent carousel.

a. When the allergen wedge is scanned successfully, which screen appears?

______________________________________________________

b. What mode must the system be in before you scan an allergen wedge?

______________________________________________________

4. Label 2 tubes with the appropriate barcode labels for the allergy adjustors.Transfer the low and high adjustor material into the appropriate tubes.

5. Label 2 tubes with the appropriate barcode labels for the kit-specific allergycontrols found in the allergy kit box. Transfer the level 1 and level 2 controlmaterial into the appropriate tubes.

6. Place the adjustors and controls in a sample rack and load the sample rack onthe system.

7. Order the allergy adjustor tests.

Where can the adjustor allergen lot number be found?

______________________________________________________

Allergy


8. Order the kit-specific allergy control tests.

a. What is the appropriate test category used to order controls?

______________________________________________________

b. How will the test code appear for the kit-specific allergy controls on theAvailable Test screen?

______________________________________________________

Allergy


T03010.003 IMMULITE 2000 XPi System Onsite Title Page.docT03010.003 IMMULITE 2000 XPi System Onsite Sec01-Welcome.docT03010.003 IMMULITE 2000 XPi System Onsite Sec02-System Components.docT03010.003 IMMULITE 2000 XPi System Onsite Sec03-Software Overview.docT03010.003 IMMULITE 2000 XPi System Onsite Sec04-Daily Maintenance.docT03010.003 IMMULITE 2000 XPi System Onsite Sec05-Kit Entry and Adjustment.docT03010.003 IMMULITE 2000 XPi System Onsite Sec06-Quality Control.docT03010.003 IMMULITE 2000 XPi System Onsite Sec07- Sample Processing.docT03010.003 IMMULITE 2000 XPi System Onsite Sec08-Validating Adjustments.docT03010.003 IMMULITE 2000 XPi System Onsite Sec09- Maintenance.docT03010.003 IMMULITE 2000 XPi System Onsite Sec10- Troubleshooting.docT03010.003 IMMULITE 2000 XPi System Onsite Sec11-Allergy.doc

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