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
IMMULITE 2000 XPi Immunoassay System 2-3
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
2-4 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 2-5
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
2-6 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 3-1
3 Software Overview
Software Overview
3-2 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 3-3
Exercise Activity and Questions
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
3-4 IMMULITE 2000 XPi Immunoassay System
Daily Maintenance
IMMULITE 2000 XPi Immunoassay System 4-1
4 Daily Maintenance
Daily Maintenance
4-2 IMMULITE 2000 XPi Immunoassay System
Daily Maintenance
Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide
· Online Help
· Daily Maintenance Online Training Course
ObjectivesUpon completion of this exercise you will be able to:
· 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
IMMULITE 2000 XPi Immunoassay System 4-3
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
4-4 IMMULITE 2000 XPi Immunoassay System
Exercise Activity and Questions
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
IMMULITE 2000 XPi Immunoassay System 4-5
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
4-6 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 4-7
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
4-8 IMMULITE 2000 XPi Immunoassay System
Kit Entry and Adjustment
IMMULITE 2000 XPi Immunoassay System 5-1
5 Kit Entry and Adjustment
Kit Entry and Adjustment
5-2 IMMULITE 2000 XPi Immunoassay System
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
ObjectivesUpon completion of this exercise you will be able to:
· Scan kit bar codes.
· Load the bead packs and reagent wedges.
· Run adjustors.
Kit Entry and Adjustment
IMMULITE 2000 XPi Immunoassay System 5-3
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?
Kit Entry and Adjustment
5-4 IMMULITE 2000 XPi Immunoassay System
_______________________________________________________
c. When will the Reagent and Bead screens be updated to reflect thecomponents loaded on the instrument?
_______________________________________________________
3. Select the Run button.
Kit Entry and Adjustment
IMMULITE 2000 XPi Immunoassay System 5-5
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:
Kit Entry and Adjustment
5-6 IMMULITE 2000 XPi Immunoassay System
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.
Kit Entry and Adjustment
IMMULITE 2000 XPi Immunoassay System 5-7
Display/Edit Screen
Kit Entry and Adjustment
5-8 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 6-1
6 Quality Control
Quality Control
6-2 IMMULITE 2000 XPi Immunoassay System
Quality Control: Practical Exercise
Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide
· 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
IMMULITE 2000 XPi Immunoassay System 6-3
Exercise and Activity Questions
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
6-4 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 6-5
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
IMMULITE 2000 XPi Immunoassay System 7-1
7 Sample Processing
Sample Processing
7-2 IMMULITE 2000 XPi Immunoassay System
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
ObjectivesUpon completion of this exercise you will be able to:
· 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
IMMULITE 2000 XPi Immunoassay System 7-3
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
7-4 IMMULITE 2000 XPi Immunoassay System
Exercise and Activity Questions
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
IMMULITE 2000 XPi Immunoassay System 7-5
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
7-6 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 7-7
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
7-8 IMMULITE 2000 XPi Immunoassay System
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-1
8 Validating Adjustments
Validating Adjustments
8-2 IMMULITE 2000 XPi Immunoassay System
Validating Adjustments Practical Exercise
Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide
· Online Help
· Adjustment Online Training Course
ObjectiveUpon completion of this exercise you will be able to validate adjustments.
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-3
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.
Validating Adjustments
8-4 IMMULITE 2000 XPi Immunoassay System
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.
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-5
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:
Validating Adjustments
8-6 IMMULITE 2000 XPi Immunoassay System
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-7
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
8-8 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-9
AdjustmentLab Name: Instrument ID B0003
Instrument S/N B0003
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
Low Adjustor 17,781,280Test Code CPS Lot# Date Time
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%
High Adjustor 3,293,232Test Code CPS Lot# Date Time
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:
Intercept Guideline:
Validating Adjustments
8-10 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-11
Page 1Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
8-12 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-13
AdjustmentLab Name: Instrument ID B0070
Instrument S/N B0070
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)
High Adjustor 2,169,118Test Code CPS Lot# Date Time
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:
Intercept Guideline:
Validating Adjustments
8-14 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-15
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
8-16 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-17
AdjustmentLab Name: Lab/ISD - EX 4 Instrument ID B0003
Readjustment Instrument S/N B0003
Test Code E2 Kit Lot 162 Agn Lot
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
Low Adjustor 10,613,180Test Code CPS Lot# Date Time
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%
High Adjustor 1,081,389Test Code CPS Lot# Date Time
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
Validating Adjustments
8-18 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
Date Time Test Lot Range CPS Result Units Z-Score9/5/2006 10:42:51AM E2 162 59-95 4,443,371 54 LOW pg/mL -2.5
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-19
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
Date Time Test Lot Range CPS Result Units Z-Score9/5/2006 10:43:09AM E2 162 175-275 2,180,749 154 LOW pg/mL -2.84
Validating Adjustments
8-20 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-21
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
Low Adjustor 30,622Test Code CPS Lot# Date Time
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%
High Adjustor 4,212,020Test Code CPS Lot# Date Time
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
Validating Adjustments
8-22 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-23
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
8-24 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-25
AdjustmentLab Name: Instrument ID B0010
Instrument S/N B0010
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
High Adjustor 14,727,030Test Code CPS Lot# Date Time
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%
Low Adjustor 37,396,440Test Code CPS Lot# Date Time
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%
Adjustment CompleteReport Date3/30/2006
Lab/ISD - EX 6
Readjustment
Instrument Slope Range: ±10% of Previous TT4 Slope:
TT4 Average Slope:
Intercept Guideline:
Validating Adjustments
8-26 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-27
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
8-28 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-29
AdjustmentLab Name: Instrument ID B0070
Instrument S/N B0070
Test Code E2 Kit Lot 164 Agn Lot
Slope Intercept0.804-1.21 N=31 391,578
1.057 N=5
Low Adjustor 20,123,400Test Code CPS Lot# Date Time
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)
High Adjustor 2,330,949Test Code CPS Lot# Date Time
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:
Intercept Guideline:
Validating Adjustments
8-30 IMMULITE 2000 XPi Immunoassay System
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
Low Adjustor 52,646Test Code CPS Lot# Date Time
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%
High Adjustor 9,653,727Test Code CPS Lot# Date Time
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%
Adjustment CompleteReport Date6/10/2006
Lab/ISD - EX 8
Initial Adjustment
Instrument Slope Range: ±10% of Previous HCG Slope:
HCG Average Slope:
Intercept Guideline:
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-31
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
8-32 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-33
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
8-34 IMMULITE 2000 XPi Immunoassay System
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
Low Adjustor 52,646Test Code CPS Lot# Date Time
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%
High Adjustor 9,653,727Test Code CPS Lot# Date Time
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%
Adjustment CompleteReport Date8/10/2006
Lab/ISD - EX 9
Readjustment
Instrument Slope Range: ±10% of Previous HCG Slope:
HCG Average Slope:
Intercept Guideline:
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-35
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 4Expiration Date: 5/31/2007
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
Validating Adjustments
8-36 IMMULITE 2000 XPi Immunoassay System
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 5Expiration Date: 5/31/2007
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
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-37
Page 1
Control
Control Name: CON6Control Lot: 020Control Level: 6Expiration Date: 5/31/2007
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
Validating Adjustments
8-38 IMMULITE 2000 XPi Immunoassay System
Adjustment
Lab Name: Instrument ID B0065
Instrument S/N 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%
Adjustment CompleteReport Date8/13/2006
Lab/ISD - EX 10
Initial Adjustment
Previous CVG Index:CVG Average Index:
Validating Adjustments
IMMULITE 2000 XPi Immunoassay System 8-39
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
Validating Adjustments
8-40 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 9-1
9 Weekly, Monthly, and Quarterly Maintenance
Weekly, Monthly, and Quarterly Maintenance
9-2 IMMULITE 2000 XPi Immunoassay System
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, Monthly, and Quarterly Maintenance
IMMULITE 2000 XPi Immunoassay System 9-3
Weekly Maintenance
Maintenance Procedure Purpose
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
Maintenance Procedure Purpose
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
Maintenance Procedure Purpose
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
11-4 IMMULITE 2000 XPi Immunoassay System
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
Weekly, Monthly, Quarterly Maintenance
IMMULITE 2000 XPi Immunoassay System 9-5
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, Monthly, Quarterly Maintenance
9-6 IMMULITE 2000 XPi Immunoassay System
Exercise and Activity Questions
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.
Weekly, Monthly, Quarterly Maintenance
IMMULITE 2000 XPi Immunoassay System 9-7
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
IMMULITE 2000 XPi Immunoassay System 10-1
10 Troubleshooting
Troubleshooting
10-2 IMMULITE 2000 XPi Immunoassay System
Sample and Instrument TroubleshootingPractical Exercise
Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide
· Online Help
· Troubleshooting Online Training Course
ObjectiveUpon completion of this exercise you will be able to discuss commonoperators errors and the help screen
Troubleshooting
IMMULITE 2000 XPi Immunoassay System 10-3
Clot Troubleshooting
Case 1The instrument detects a clot in the sample tube.
Troubleshooting
10-4 IMMULITE 2000 XPi Immunoassay System
Case 2The instrument detects a hanging clot.
Troubleshooting
IMMULITE 2000 XPi Immunoassay System 10-5
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
IMMULITE 2000 XPi Immunoassay System 11-1
11 Allergy
Allergy
11-2 IMMULITE 2000 XPi Immunoassay System
Allergy Practical Exercise
Resources· IMMULITE® 2000 XPi Immunoassay System Operator’s Guide
· 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
IMMULITE 2000 XPi Immunoassay System 11-3
Exercise and Activity Questions
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
11-4 IMMULITE 2000 XPi Immunoassay System
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
IMMULITE 2000 XPi Immunoassay System 11-5
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
11-6 IMMULITE 2000 XPi Immunoassay System
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