GPE01006.005 Sec OPGuide

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ADVIA® Chemistry 1200 – 1650 – 1800 - 2400

Secondary Operator’s Training Guide

Copyright 2008 by Siemens Healthcare Diagnostics Inc. ALL RIGHTS RESERVED.

ADVIA® is a registered trademark of Siemens Healthcare Diagnostics Inc.


All other products mentioned are trademarks of their respective companies.
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Table of Contents

INTRODUCTION .....................................................................................................................................5
GUIDELINES FOR A SUCCESSFUL TRAINING ...................................................................................7
TRAINING CHECKLIST ..........................................................................................................................9
Secondary Operator Training Checklist 1 .....................................................................................11
Secondary Operator Training Checklist 2 .....................................................................................13

Lesson Plan 1.......................................................................................................................................15


Analyzer Components .....................................................................................................................15
Solutions & Reagents ......................................................................................................................16
Use of Operation Panel....................................................................................................................17
Calibration/QC ..................................................................................................................................18
Specimen Analysis ..........................................................................................................................20
Daily Maintenance............................................................................................................................22

LESSON PLAN 2 ..................................................................................................................................24


After One Month of Hands on Operation .......................................................................................24
Calibration ........................................................................................................................................24
QC......................................................................................................................................................24
Weekly Maintenance ........................................................................................................................25
Monthly Maintenance.......................................................................................................................26
Other Maintenance...........................................................................................................................26
Other Maintenance: ISE’s...............................................................................................................28
Parts Replacement...........................................................................................................................29
Reboot Procedures ..........................................................................................................................30
Reaction Monitor Window ...............................................................................................................31
Misread Reagent Barcodes or 3rd Party Reagents ........................................................................32
Handling \\\\ on Patient Results ......................................................................................................33
Setting up an Assay to AutoCal & QC on Wedge Rollover ..........................................................33

Appendix 1: Analyzer Components ...................................................................................................34


Appendix 2: Solutions & Reagents ....................................................................................................36
Appendix 3: Solutions & Reagents ....................................................................................................40
Appendix 4: Operation Panel..............................................................................................................41
Appendix 5: Calibration & QC............................................................................................................42
Appendix 6: ISE’s.................................................................................................................................43

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Appendix 7: Specimen Analysis........................................................................................................44
Appendix 8: Calibration & QC also reinforces use of the Alarm Log ............................................45
KEYs to Appendices............................................................................................................................47
Appendix 1: Analyzer Components ...................................................................................................49
Appendix 2: Solutions & Reagents ....................................................................................................51
Appendix 3: Solutions & Reagents ....................................................................................................55
Appendix 4: Operation Panel.............................................................................................................56
Appendix 5: Calibration & QC............................................................................................................57
Appendix 6: ISE’s.................................................................................................................................58

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INTRODUCTION

The purpose of this training guide is to provide you with the materials to assist in training secondary
operators.

This guide is meant to be used in conjunction with the ADVIA Chemistry Training Manual received
during the training class in Tarrytown and the Supplemental Training Aid (STA) ordered by the TAS for
implementation.

The customer and TAS will partner together to complete the training checklists.

‰ Guidelines for a Successful Training

‰ ADVIA Chemistry Secondary Operator Training Checklists

‰ Lesson Plans

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GUIDELINES FOR A SUCCESSFUL TRAINING

A. Preparation
1. Create a relaxed, learning atmosphere.
2. Trainees only responsibility during the session should be training.
3. Discuss the goal of the training session.
4. Present training schedule. Discuss the content to be certain it is mutually agreeable and
will meet everyone’s expectation.
5. REMEMBER: You are the instructor; lead with commitment, enthusiasm, and
professionalism.
6. Always be open, honest and approachable. Encourage questions and active
participation.

B. Instruction
1. Be sure to have a Training Manual from Tarrytown for reference
2. Be sure the STA is readily available
3. Present one important topic at a time.
4. Discuss and demonstrate each step. Be certain to STRESS key steps by referring to the
checklist.
5. Ask questions while proceeding to confirm their comprehension.
6. Give the operator as much hands-on time as possible.

C. Evaluation
1. Observe operators while they are performing the tasks with as little intervention as
possible.
2. Ask the operator to explain what she is doing and why.
3. Ask many questions. Present scenarios and case studies and ask for explanations.

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TRAINING CHECKLIST

All subject matter in the checklist MUST be covered to constitute a


thorough training session. Introduce the checklist to the operator at the
beginning of the training and refer to it during the course of the session.
The operator should check off each topic as it is covered.

If the training cannot be completed in one session, break up the lesson


plan into smaller segments.

Keep training groups small enough in order to allow each trainee


sufficient hands-on time if possible.

The trainee should be able to demonstrate each Objective before


proceeding to the next section.

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ADVIA® Chemistry

Secondary Operator Training Checklist 1

Operator Name: __________________________ Signature: ________________________


Trainer Name: __________________________ Signature: ________________________
Facility Name: ___________________________ Serial #___________ Date: __________
Check off each topic as it is addressed. If items are not applicable to your lab, write NA next to that
item. Once complete, the operator and trainer should review and sign the checklist.

Identify Analyzer Components Calibration


… Computer and On/Power button … Calibration Intervals & Status
… ISE Components … Location of calibrators on the CTT/STT
… Location and use of bulk solutions; … Perform Daily Reagent Blanks (RBL’s)
Refill & Prime as needed … Perform 1 point calibration
o Saline, Cuvette Conditioner & … Perform multi-point calibration
Wash, Inc. Bath Oil … View Cal Curve
o Lamp Coolant … Enter Cal Factor Values
o ISE Buffer … Perform ISE Calibration & Interpret data
o Reference Solution (1650 only)
… Various trays, probes, mixers, wash QC
mechanisms, lamp etc. … Identify
… Display panel & main power switch o QC to run
… Rack Handler or track if applicable o Positions on the CTT
o Daily Precision Control Screen
Solutions & Reagents o QC Cumulative save
… Preparation
o 1 & 2 reagent assays Specimen Analysis
o R1 & R2 exclusive pairs … Sample & container types
o Use of adapters … Order Entry Screen for manual ordering
… Use of Reagent Inventory o Barcoded & non-barcoded
o Primary vs. Backup … Test Result Monitor
o Yellow & red highlights … Real Time Monitor
o Pass/Fail … Interpret Sample data & result flags
… Active Test List … Review/Edit
… Reagent Barcode Scan
… User Defined Reagent Daily Maintenance
o Assigned positions … New Start (vs. Restart)
o Reagent Container Set … Prepare CTT, RTT1 & RTT2 for Shutdown
Wash 2
Use of Operation Panel o DI H2O
… Start o Probe Wash 1 & 2
… Pause Reagent & Sample o 10% Cuvette Wash/ 5% Probe Wash 3
… Prime … Inspect/clean ISE’s, probes, wash cups,
… Wash mixing rods, WUD/DWUD, splash covers
… Initialize … Check pumps for leaks
… Alarm … Check lamp coolant
… Buzzer … Shutdown wash 2 with electrode wash
… Help (On-Line Op Guide) … Clean electrodes using ISE Maintenance
… Sample Load Box … Appropriate use of RED Emergency Stop
… Sign In Levels button

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ADVIA® Chemistry

Secondary Operator Training Checklist 2


After One Month of Operation
Operator Name: __________________________ Signature: ________________________
Trainer Name: __________________________ Signature: ________________________
Facility Name: __________________________ Serial #___________ Date: __________

Check off each topic as it is addressed. If items are not applicable to your lab, write NA next to that
item. Once complete, the operator and trainer should review and sign the checklist.

Calibration Parts Replacement


… View CalCurve/Troubleshoot failed cal … ISE electrodes
… Setup Auto cal on wedge rollover … Lamp
… SPP Probe
QC … RPP probes
… QC Setup … DPP probe (N/A 1200)
o Enter a new lot of QC
o Enter/edit Mean & 1SD range Reboot Procedures
… Reboot/Shutdown workstation computer
Weekly Maintenance … Power down/HardBoot
… Weekly Wash … Use of standby switch on analyzer
… Lamp Energy Check … System Backup
… Cuvette/ Cell Blank
… 1650 only Reaction Monitor Window
o Clean ISE Dilution Bowl … Review use
o Mixer
Misread Reagent Barcodes or 3rd Party Reagents
Monthly Maintenance … Assigning reagent tray positions
… Clean turntable interiors
… Clean chiller filter Handling \\\\ on patient results
… Clean & replenish Solution bottles … Interpretation using View Cal Curve
o Saline
o Cuvette Wash
o Cuvette Conditioner
… Drain vacuum tank 1650/2400 only
… 1650 only
o Replace ISE peripump tubing
o Replace ISE pump seal & packing
o Clean ISE waste block

Other Maintenance
… Clean replace DTT cuvettes
(N/A 1200)
… Replace RRV cuvettes
… Clean ancillary bottle filters
… Clean water bottle filter(s)
… Wash electrode lines
… Condition/Replace electrodes

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LESSON PLAN 1
Analyzer Components
Locate & discuss each of the following components with the trainees at the system.

1. Identify System computer


ƒ On/Power button
ƒ CD/DVD drive
2. ISE Module; discuss importance of keeping clean (salt bridges)
ƒ Electrodes
ƒ Dilution bowl
ƒ Waste drain
ƒ Buffer
ƒ 1650 only
y Peripump
y Buffer pump
y Reference Solution & Reference Electrode
3. Bulk Solutions; locate and discuss refilling, priming and usage
ƒ Bath Oil
ƒ Oil Overflow bottle
ƒ Saline
ƒ Cuvette Wash
ƒ Cuvette Conditioner
ƒ Lamp Coolant
4. Locate, describe function and assigned positions on trays
ƒ Trays: CTT/STT, DTT, RRV, RTT1 & 2
ƒ Probes: DPP, SPP, RPP1 & 2
ƒ Mixers: DMIX, MIX 1 & 2
ƒ Wash Mechanisms: DWUD & WUD
ƒ Lamp
ƒ Oil Sensors
4. Display Panel & Main Power Switch
ƒ Indicator Lights
ƒ Emergency Stop
ƒ Operate/Standby Switch
ƒ Power
5. Review use of Rack Handler or Track as needed

Objective: Identify major components of the system. (Exercise Appendix 1)

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LESSON PLAN 1
Solutions & Reagents
Have bottles of solutions & boxes of reagents to demonstrate how they come packaged. Also
have different adapters ready for demo.

1. Show stock bottles and discuss hazards of


ƒ Cuvette Wash
ƒ Cuvette Conditioner
ƒ Incubation Bath Oil ;stress slipping hazard
ƒ 0.9% Isotonic Saline
ƒ Use of funnels and pouring from side of bottle to limit splash
ƒ ISE Buffer
ƒ Probe Wash 1-2-3
ƒ Lamp Coolant additive
ƒ ISE Detergent
ƒ ISE Reference solution (1650)
ƒ ISE Internal fill solution (1650)
2. Discuss preparation, usage and positions of working solutions
ƒ 10% Cuvette Wash
ƒ 5% Probe Wash 3
ƒ 5% Lamp Coolant
3. Show different reagent packaging
ƒ R1 only
ƒ R1 & R2
ƒ RTU (ready to use)
ƒ Some need preparation e.g. GLU Hex
ƒ Discuss exclusive pairs
ƒ Demonstrate adapters
4. Discuss Reagent Inventory window usage
ƒ Barcode Scan
ƒ Primary vs. backup
ƒ Yellow and red highlight warnings
ƒ Cal interval
ƒ Pass/ fail
ƒ Resizing the screen
ƒ Positions of wash solutions at bottom of window
ƒ Screen always in task bar at bottom
5. Explain Active Test List
ƒ Sign in as supervisor
ƒ Changes will take effect only in the READY state
ƒ All tests routinely running should be ;
6. Identify User Defined Reagents if needed
ƒ Assigning tray positions on RTT 1 & 2 in System Test List
y Sign in as supervisor
y Stress consequences of improper changes to this window
y Assigned positions should not be used for barcoded reagents and why
ƒ Opening a new wedge in Reagent Container Set window to start OBS clock

Objective: Fill solutions, put on reagents & perform a barcode scan (Exercise Appendix 2 & 3 )

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LESSON PLAN 1
Use of Operation Panel
At the system discuss Operation Panel Buttons, Icons & Status Fields:

1. Start (Condition Window)


ƒ Calibration
y Single vs. multi point
y Ordinary vs.special (no difference; can be used as additional default for multi pt.)
y Test Select & Sample Select
y Default Selections
ƒ Control
y Test Select & Sample Select
y Default Selections
ƒ Ordinary Sample
y Stress use of Barcode Mode for patient samples over Cup Position
y Designating STT positions to scan
y Temp.cup/tube select option
ƒ Outside Analyzer (if applicable)
2. Reagent Pause
ƒ Stress waiting for ADD REAGENTS
ƒ Not always active; refer to Training ManualÎReagent & Solutions
ƒ Should not be used for start of shift routine reagent loading
ƒ Most useful after barcode scan to add missing reagents
3. Sample Pause
ƒ Stress waiting for ADD SAMPLES
ƒ Used to add routine or STAT samples while system is running
ƒ Available through software or touch pad
4. Stop
ƒ Stops sample aspirations
ƒ Samples dispensed into RRV finish processing
ƒ Analyzer returns to READY
5. Wash
ƒ Daily Wash 2
ƒ Startup Wash 3 if not 24/7
6. Prime
ƒ Use Prime 2 (10x) after
y Filling system solutions
y After changing probes
7. Initialize
ƒ From the WAIT state
ƒ Always after using Manual Operations
8. Host Off
ƒ Toggles to Host On
ƒ Allows communication to Host/CLINK
9. Alarm Icon
ƒ Stress importance
ƒ Look for 1st occurrence in time frame
ƒ Double click for more info
10. Sign In Levels:
ƒ SystemÎPassword: User & Supervisor

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LESSON PLAN 1
Use of Operation Panel (cont’d)

10. Buzzer Icon


ƒ Silences the audible alarm
11. Help/Information Icon
ƒ Opens the Operator’s Guide
ƒ Stress importance
ƒ Demonstrate how to use
y Menu
y Forward/back
y Print
y Use of links
y Available on each window
12. Status Fields (refer to Training Manual System Overview/ page 28)
ƒ System status
ƒ Messages
ƒ Alarm box
ƒ Time remaining
Objective: Use the Op Guide (Exercise Appendix 4 )

Calibration/QC
At the system discuss:

1. Holds cal curves for 2 reagent lots


2. Review cal intervals on Reagent Inventory
3. Review different Calibrator & QC materials
4. Discuss locations of Calibrators & QC
ƒ Single pt cals on CTT
ƒ Multi pt cals on STT
ƒ ISE’s ( not good onboard after 15 minutes)
ƒ All QC on CTT
5. Discuss assays using single vs. multi pt. cals
ƒ Identify
y What needs a daily RBL
y What needs a daily cal
y Which assays are single pt. cals
y Which assays are multi pt. cals
y What QC goes with what assays
ƒ Demonstrate scheduling a full Cal vs. an RBL only
y Discuss Temp. Item & Temp. Sample Select
y Explain Default setup
y QC is always included with calibration
6. Discuss monitoring the calibration
ƒ RequestÎTest Result monitor
y Will not see ISE calibrators
ƒ RequestÎReal Time Monitor
y Look for marks/flags
y Identify various cals and qc (refer to Training ManualÎColorCalÎID’s for cal’s & qc)
ƒ Cal status on Reagent Inventory

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LESSON PLAN 1

Calibration/QC (cont’d)
7. Review View Cal Curve
ƒ Demonstrate how to print current cal curves for inspection purposes
8. Demonstrate how to enter a new lot # of calibrator
ƒ Review package insert
ƒ Sign in as supervisor
ƒ CalibrationÎCal SetupÎCtrl/Cal SetupÎenter new Lot# and exp. dateÎSave
ƒ Discuss how to have lot# show up in START menu
ƒ CalibrationÎCal SetupÎenter all new cal valuesÎSave
ƒ MUST CAL ALL assays using the new calibrator
ƒ Discuss
y Single vs. multi pt entries
y FV values for enzymes
9. Discuss ISE calibration done from START and MaintenanceÎISE Operation
ƒ A buffer prime is needed before the ISE cal if the buffer was changed, any maintenance has
been performed or the system has been idle
ƒ Be sure to clean ISE dil bowl and waste drain before cal
ƒ Explain why ISE’s are
y Normally done from START
y Done from ISE OP’s after ISE maintenance or troubleshooting issues
10. Identify ISE calibration criteria (refer to Training ManualÎISE’s; also available in STA)
11. Discuss QC Review
ƒ Real Time Monitor
ƒ Daily Precision Control (if applicable)
ƒ QC Cumulative (if applicable)
y Save to Cumulative only once a day

Objective: Perform successful calibrations and process QC (Exercise Appendix 5 & 6)

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LESSON PLAN 1
Specimen Analysis
At the system discuss:

1. Review sample & container types that will be used


2. Review RequestÎOrder Entry window
ƒ Schedule barcoded samples
• Select New
• Routine vs. Interrupt
• Sample No. (barcode#)
• Container field
• Test Table & Profiles
• EnterÎNew
ƒ Schedule non-barcoded samples
• Select New
• Routine vs. Interrupt
• Use patient name if no barcode#; e.g. smith-baby-a
• Container field
• Test Table & Profiles
• EnterÎNew
ƒ Use View Worklist to check for entry errors
3. Discuss the benefits of using the STT in sequential order
ƒ Easier to locate specimens not processed
ƒ White dot among pink dots on Test Result Monitor means either: a barcode did not read
and needs to be rescanned or there is no request

Objective: Enter requests for barcoded & non-barcoded samples. (Exercise Appendix 7)

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LESSON PLAN 1
Specimen Analysis

At the system process the scheduled samples:

1. Start Button
ƒ Process Ordinary Samples
y Analyzer Mode: ; barcode; even if running non – barcoded samples
y Limited use of tray/ cup mode; useful for evaluating QC or precision studies
y Positions to scan
y ; Analyze
2. When the Sample Confirmation Window appears
ƒ Click timer off
ƒ Observe successful scan; colors
ƒ Explain entry of barcode or name in the correct position for non-barcoded samples
ƒ Process the run
3. Monitor the run
ƒ Observe the processing samples on Test Result Monitor
4. Review the results in
ƒ Real time monitor
y Discuss standard view headings (Refer to Training Manual; Daily OpsÎp.15)
y Identify result flags (Refer to Training Manual: Daily OpsÎp.18)
5. Review results in RequestÎReview & Edit (if applicable)
ƒ Explain a manual vs. auto rerun
ƒ Schedule 1 sample for a total rerun
ƒ Observe change in status
ƒ Process the rerun from Start
ƒ When completed, review results

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LESSON PLAN 1
Daily Maintenance

At the system demonstrate, discuss and observe (following the procedures in the OP Guide or
Training Manual):

NOTE: Stress Daily maintenance should only take a few minutes once the trainee becomes familiar
with the procedures. Performing tasks in a specific order as outlined below can save valuable time
and make the tasks even easier.

1. New Start vs. Restart


2. Discuss positions & solutions for daily shutdown Wash 2
ƒ Prepare & replace solutions for Daily Wash 2 when doing reagent inventory to save time
ƒ CTT & RTT
y Training Manual MaintenanceÎp.18
y Labeled positions for
Š DI H2O-change daily
Š ISE Detergent-fresh cup daily
Š Probe Wash 1 & 2-at least ¾ full
Š 10% Cuvette Wash or 5% Probe Wash 3
Š Stress need to replace 5% PW3 with 10% CW when processing samples
3. Inspect/Clean if needed
ƒ ISE’s
y Check for salt bridges; dil bowl, waste drain, solution drawer
y Demo “squirt-squirt” to clean dil bowl & waste drain; let sit while completing other daily
activities
ƒ Probes, wash cups
y Remove CTT and RTT covers
y Use MaintenanceÎManual Operations to move probes to accessible locations
Š Always clean the DPP & SPP
Š Probe wash cups are now more accessible to clean if necessary; be careful of
overflow sensors
ƒ CTT/RTT’s; monthly activity, but may need to be done more frequently
y While covers are still off, check for excess condensation & remove if necessary
ƒ Mixing rods
y Inspect with pen light if available, gently clean with DI H2O & kim wipe only if
necessary
ƒ WUD/DWUD
y Wipe nozzles with kim wipe & DI H20
y Once processing observe aspiration lines (blue & yellow) & splash covers
ƒ Splash covers
y Clean up spills when noticed
y Look for evidence of leaky probes
y If bottom is wet, check WUD/DWUD for aspiration problem
4. Check pumps for leaks
5. Check Lamp Coolant
6. Replace covers & INITIALIZE

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LESSON PLAN 1
Daily Maintenance
At the system demonstrate or discuss (following the procedures in the OP Guide or Training
Manual):

7. Clean Electrodes using ISE Maintenance


ƒ Useful for Chloride bias issues
ƒ Never more than 3x in 24 hours including the Wash 2
ƒ Calibration & QC must be run after performing this procedure
8. Appropriate use of the RED Emergency Stop button
ƒ If used while reagents are in the RRV, will need to perform a Wash 2 before running
samples (contamination sets not delivered)
ƒ Can be used at end of shift if the next activity to be performed is the Wash 2

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LESSON PLAN 2
After One Month of Hands on Operation

Calibration
At the system:

Troubleshooting a Failed Colorimetric Calibration; failed ISE’s discussed on pg.29


1. CalibrationÎView Cal Curve: Explain how RBL corrected absorbance is plotted against the
concentrations of the stds
ƒ Single pt. curve
ƒ Multi pt. curve
y Increasing & decreasing calibration curves
ƒ RBL check
ƒ Cal check
y Review how these can be viewed to determine WHY cal failed:
Š Precision
Š Value of cal
Š Cal tracking etc.
2. CalibrationÎRBL/Cal History
ƒ Demonstrate different ways to sort assays
y Data associated with latest cals
y Data associated with 1 particular assay (demo single & multi)
y Compare 2 assays
y ISE’s
y Sort by date
3. Discuss possible causes for a failed cal
ƒ Look for commonalities of what worked vs. what did not work
y Calibrator
y Probes
y Maintenance performed
ƒ Common human errors
y Improperly diluted calibrator
y Wrong calibrator
y Bubbles
y Etc.
ƒ System issues
y Probes
y Pumps
y WUD/DWUD
y Etc.

QC
At the system :

1. Demonstrate how to enter a new lot# or edit an existing lot# of QC (if applicable)
ƒ Sign in as supervisor
ƒ QCÎCtrl/Cal SetupÎenter new lot# and expiration date
ƒ QCÎCtrl/Cal SetupÎCtrl Data SetupÎenter/edit mean & 1SD valuesÎSave
Objective: perform ‘BUG’ run if time allows (Exercise Appendix 8 )

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LESSON PLAN 2
After One Month of Hands on Operation

Weekly Maintenance
At the system perform & discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

1. Weekly Wash
ƒ May be the daily shutdown wash 2 in specific circumstances
ƒ Stress the need to replace the 5% PW3 with 10% CW when the wash is completed and
before running samples for correct dispensing of contamination sets
2. Lamp Energy Check
ƒ Should precede Cuvette/Cell Blank
ƒ Discuss pass/fail criteria
ƒ Scatter plot <40
ƒ Voltage 5-9
ƒ Attenuation >80%
ƒ Do not register data when doing the weekly check
ƒ Screen print and Save in maintenance log
3. Cuvette/Cell Blank (CB)
ƒ Should be done after the shutdown wash
ƒ Should be done after Lamp Energy Check
ƒ Can be scheduled to be done with Auto Start Up if applicable
ƒ Be sure to have enough Cuvette Conditioner
ƒ Print Statistics & Abnormal Cells from Real Time Monitor
ƒ Discuss possible flags and troubleshooting
ƒ Save in maintenance log

1650 Specific
4. Clean ISE Dilution Bowl
5. Clean ISE mixer ( Monthly activity, but best to do more frequently to prevent problems)

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LESSON PLAN 2
After One Month of Hands on Operation

Monthly Maintenance
At the system perform & discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

1. Clean turntable interiors


ƒ Demo correct repositioning of RTT’s
2. Clean chiller filter
3. Clean & replenish solution bottles
ƒ Saline
ƒ Cuvette wash
ƒ Suggest doing the Cuvette conditioner bottle (this is a 2 month activity but easier to do all at
the same time)
4. Clean/replace wash solution containers on CTT & RTT’s

1650/2400 Specific
5. Drain vacuum tank
1650 Specific
6. Replace ISE peripump tubing
ƒ May need to be done more frequently in high volume accounts
ƒ Be careful not to twist the tubing as you bring it around the pump
7. Replace ISE pump seal & packing
8. Clean ISE waste block
ƒ If rinsed daily will probably not need to be done

Other Maintenance
At the system perform &/or discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

1. DTT cuvettes: Clean every 2 months/Replace every 4 months


2. Clean/Replenish cuvette conditioner bottle (2 mo.)

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LESSON PLAN 2

After One Month of Hands on Operation

Other Maintenance cont’d


At the system perform & discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

3. Change the lamp (3mo.)


ƒ Lamp is guaranteed for 2000 hours ~3 months
ƒ Put it on your schedule; be proactive
ƒ Needs to burn in for at least 40 min
y For efficiency, at end of day
Š Change the lamp
Š Daily Wash 2
Š Lamp Energy check
Š Register Data: Done with lamp change only
Š Cell Blank
Š Cal all colorimetric tests & QC
4. Replace RRV cuvettes (4mo.)
ƒ System must be in STANDBY
ƒ Work away from the lamp
ƒ Remove all segments at the same time
ƒ Inspect the oil bath; clean if necessary
NOTE: To save time, schedule this activity to coincide with the weekly wash, then follow with the lamp
energy & CB.
5. Clean ancillary bottle filters (4 mo.)
6. Clean onboard water bottle filters (4 mo.)

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LESSON PLAN 2

After One Month of Hands on Operation

Other Maintenance: ISE’s


At the system perform & discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

NOTE: Demonstrating the ISE Wash Electrode Lines can be done in conjunction with discussion of
Conditioning Electrodes and Changing Electrodes. This is more effective for the trainer and trainees.
Then follow with ISE troubleshooting scenarios.

NOTE: If your laboratory runs dialysis samples

` 500 or more dialysis a month, wash electrode lines every three days.
` 100 or more dialysis a month, wash electrode lines every week.
` Less than 100 dialysis samples a month or >330 routine samples a day, wash
electrode lines once a month.
NOTE: performing this procedure monthly will also help labs running a high volume of urine
specimens

1. Wash electrode lines


ƒ Discuss/Demo up to selecting Step 1
ƒ Stress importance of watching the time field before starting Step 2 or may lock up
software
ƒ During the 17 minutes, discuss changing & conditioning electrodes
ƒ Then return to system and complete the procedure
2. Condition Na & K electrodes
ƒ Stress following the procedure in the Op Guide
ƒ CL & Ref come in a salt solution, don’t need conditioning
ƒ Demo using disposable pipette; how to dispense pool into electrode
ƒ Problem with refrigerating electrodes
y Takes hours to come to room temp before use
y Cal will drift; need to run QC more frequently to check
ƒ Discuss use of Urine CV check to condition an electrode for immediate use
y Cal will drift; need to run QC more frequently to check
3. Changing Electrodes
ƒ Na, K & CL Electrodes are guaranteed for 30,000 tests or 3 months
ƒ Change Reference electrode when value <500
ƒ Be proactive
y Record slopes daily
y Start to condition both Na & K when any slope gets to ~ 46-47
y Then change all 3 together when you do the next daily maintenance

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LESSON PLAN 2

After One Month of Hands on Operation

Troubleshooting a Failed ISE Calibration


This is more effective if done following the performance of ISE Maintenance, in a classroom
setting, if possible.

Review the ISE calibration criteria and the troubleshooting scenarios in the Training
ManualÎISEÎp.32
NOTE: ISE calibration criteria is also available in the STA

Parts Replacement
At the system perform & discuss:

Follow the directions in the Op Guide or the Training ManualÎMaintenance & 1650 Specific
Maintenance (if applicable)

1. SPP
2. RPP
3. DPP (N/A 1200)

NOTE: Lamp & Electrodes are covered in Other Maintenance

ƒ For all probes mention the following points


y Use of the cleaning tool
y Importance of screws being tight
y 1st thing when you crash any probe is to remove the probe cover and check the gap
where the probe meets the arm
y When you crash the DPP on the 1650, 1800 & 2400 check the clips are over the probe
y Be sure to prime and check for leaks before putting the cover back on
y Check that probes align over the cuvettes properly using MaintenanceÎUser
MaintenanceÎPosition Probes for Routine Cleaning (Refer to STAÎProbes for correct
positions

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LESSON PLAN 2

After One Month of Hands on Operation

Reboot Procedures
At the system perform & discuss:

Follow the directions in the STAÎReboot for:


1. Soft Boot = Reboot of software (workstation)
2. Hard Boot = Power Down; both software & system
3. Switching the Analyzer to Standby
ƒ Click on the word System in the Title Bar on the top right
ƒ Select Exit
y The software will shutdown & the Startup window will appear
ƒ You can now put the switch to Standby
4. To bring the system back up to Ready
ƒ From the Startup window
y Select New Start or Restart
y Within 15 seconds turn the system switch to Operate
y When the software menus appear
y Select initialize
y At the end of initialization the System should go to the Ready State
5. Backing Up System files: NOTE: info on formatting a CD/DVD can be found in the Misc. Tab of
the STA
a. Exit the software using the System button
b. At the Startup Window Î Backup
c. Place the CD or DVD in the drive
d. When the backup window appearsÎBackup
e. Select system and/ or data files (discuss difference)
f. The system names the file by date
g. Make sure the CD/DVD drive is selected as destinationÎ Click Execute
h. Click Execute
i. Do you want to make a backupÎOK
j. Watch for file transfer (temp. location not yet written to disc)
k. Wait for the Backup completed successfully messageÎOK
l. Hit the eject button on the CD/DVD drive; the disc will not come out yet & Wait for the Drag
to Disc window
m. On the Drag to Disc window be sure the selection is ; make readable on any…
n. Select Eject
o. Drag to Disc prep window will appear: this is when the files write to the disc
p. When completed, the disk will eject
q. Before exiting the backup window check that files are on the disk
y Push the disc back into the drive
y RT click on Start in the lower left side of the Task Bar
y Select Explore
y Select DVDÎRoxioÎToday’s date
Š If another Roxio window pops up select ;Take No Action
y On 1650, 1800 & 2400 Look for A002 & FTP folders; then close Explore window
y On 1200 look for BIOMJ & FTP
r. Select Exit on Backup windowÎEject disc; be sure to write system serial# on disc
s. Put in a safe, yet accessible place if needed for a restore

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LESSON PLAN 2

After One Month of Hands on Operation

Reaction Monitor Window


At the system discuss & demo how to:

1. Locate a reaction curve on a particular sample for a particular test (Refer to Training
ManualÎTroubleshootingÎp.30)
ƒ RequestÎReaction MonitorÎ
ƒ Make selections for
y Date
y Sample type
y Sample no.
y Test
y Be sure to ; calc results & approx curve
2. Print the screen to fax to Tech Support
ƒ SystemÎScreen Print
3. Copy the curve into Paint and save to send as an electronic copy via email
ƒ Insert a CD or Flash drive into the system PC
ƒ With the curve on screen
y Press the Alt + Print Screen buttons on the keyboard
ƒ From the task bar at the bottom of the screen
y StartÎProgramsÎAccessoriesÎPaint: an untitled Paint window opens
y Ctrl V the curve onto the blank Paint window
y Select FileÎSave As
y On the Save As window:
Š Save in: Select destination (CD or Flash Drive)
Š File Name: enter the Sample no. of the patient curve, etc.
Š Save as Type: Select 24-bit Bitmap (siz=~3mb)
Š At top of window Select ImageÎClear Image
Š Repeat if necessary
Š You can now take the file to a computer and make an email attachment to Tech
Support

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 31
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LESSON PLAN 2

After One Month of Hands on Operation

Misread Reagent Barcodes or 3rd Party Reagents


At the system discuss & demo how to:

Follow the directions with screen captures in the Training ManualÎReagents & SolutionsÎpg.21.
These directions are also available in the Misc. Tab of the STA

1. Sign in as Supervisor
2. SetupÎSystem Test List
3. Locate the test without the barcode
4. Remove the 5 digit barcode for both R1 & R2
5. Enter the positions occupied for both R1 & R2: NOTE: both reagents must be assigned positions
even if only 1 does not read.
6. Save
7. Perform a barcode scan
8. Select ReagentÎReagent Container Set
9. Locate the test and manually enter the container size, lot# and exp. date
10. Click the “o” button to start the clock for OBS. This needs to be done for both R1 & R2 NOTE:
this option will only be available for reagents without a barcode
11. Save
12. Check Reagent Inventory to be sure it has updated
NOTE: Be sure to remove the position from System Test List if the next new wedge of this
particular reagent reads properly
NOTE: For 3rd party assays, assign permanent positions. Do not put barcoded reagents in these
positions or they will have to be re-programmed.

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LESSON PLAN 2

After One Month of Hands on Operation

Handling \\\\ on Patient Results


Follow the directions with screen captures available in the Misc. Tab of the STA for additional info.

At the system discuss:

ƒ What do slash \\\\\ mean? Calculation errors


ƒ Calculation Errors = absorbance for result is outside the absorbance range for the
calibration curve
ƒ Concentration is < the lowest std or > the highest std
ƒ Most common assays TDM’s, microalbumin, wrCrp, etc.

1. Locate the corrected absorbance of the sample result on the Real Time Monitor screen
2. Open CalibrationÎView Cal CurveÎSelect the assay that generated the \\\\ marks
3. Compare the sample abs. to the corrected abs. readings of the 1st (lowest) std. & 5th (highest)std
ƒ Visually plot the sample absorbance from the Real Time Monitor on the graph
ƒ Determine if the result is low or high and report accordingly
4. Additionally, instruct how to enter values for Reabsorb. (u) and Reabsorb. (d) on the Analytical
Parameter Window with each new calibration.

After One Month of Hands on Operation

Setting up an Assay to AutoCal & QC on Wedge Rollover


Follow the directions with screen captures available in the Customer Training
ManualÎColorCalÎpg.29 or the Misc. Tab of the STA

At the system discuss & demo how to:

ƒ CalibrationÎCal SetupÎAuto.Calib.SetÎchoose tests, sample select, QC &


enforcementÎSave
ƒ CalibrationÎTest SelectÎ~ 4 & ~ 6 (1650-1800-2400)
ƒ On 1200: CalibrationÎTest SelectÎ~ 4, ~ 7 (& ~ 8 only if running the calibrator)
ƒ Save

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APPENDIX 1: ANALYZER COMPONENTS
Use this view if training 1650, 1800 or 2400

H J E I K F

D
B A G

Label the following :

1. DPP _____________
2. SPP _____________
3. RPP1 ____________
4. RPP2 ___________
5. DTT _____________
6. RRV _____________
7. DWUD ___________
8. WUD ____________
9. Oil Sensors _______
10. RTT1 _____________
11. RTT2 ____________
12. STT/CTT _________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 34
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APPENDIX 1: ANALYZER COMPONENTS
Use this view if training 1200

D
B

H
E

A C

Label the following :

1. SPP __________
2. RPP1 _________
3. RPP2 _________
4. RRV __________
5. WUD __________
6. RTT1 __________
7. RTT2 __________
8. STT/CTT _______

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 35
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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1650 identify the solutions

1 2 3 4 5 6

1. ____________________
2. ____________________
3. ____________________
4. ____________________
5. ____________________
6. ____________________

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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1800 identify the solutions

1 2 3 4 5 6

1. ____________________
2. ____________________
3. ____________________
4. ____________________
5. __________________________
6. __________________________

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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1200 identify the solutions

1 2 3 4

1. ____________________
2. ____________________
3. ____________________
4. ____________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 38
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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 2400 identify the solutions

1 2 3 4 5

1. ____________________
2. ____________________
3. ____________________
4. ____________________
5. ____________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 39
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APPENDIX 3: SOLUTIONS & REAGENTS
Depending on the system you are operating answer the following questions:

1. What are some of the functions and features of the DTT (dilution tray)?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

2. Reviewing the Reagent Inventory window, after performing a Barcode Scan, which reagents would
you need to replace?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

3. Where are Probe Wash 1 & 2 containers located and when are they aspirated?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

4. List the solutions used during the daily Shutdown Wash 2 and identify their locations on the
system?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

5. What is the most common cause of probe crashes?


______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

6. What is the proper dilution for the lamp coolant? _______________________________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 40
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APPENDIX 4: OPERATION PANEL
At the system, perform and answer the following:

1. Sign in at the User level.


2. What Menu button is missing at this level? __________________________
3. If after adding reagents, performing a barcode scan & starting your run, you notice that the R1
reagent for Glucose is missing. What button would you use to correct the situation?
___________________________
4. What feature will you use to add routine or STAT samples to the STT and how can the feature be
accessed?
______________________________________________________________________________
______________________________________________________________________________
5. Perform a Prime 2 and watch the R1 probe and Wash Station. In what situation would you use this
feature? _______________________________________________________________________
6. Open the Operator’s Guide. Search for the term flagsÎlist of alarm marks. What would an “s”
mean if seen on a patient result?
______________________________________________________________________________
______________________________________________________________________________
7. You are running samples downloaded from your LIS. When you start the run, the samples do not
process and the system goes back to READY. Which Menu button would you check to make sure
the communication link is established between the LIS and system? _______________________
8. Open the Alarm icon. Scroll down till you see a message with a yellow S or red 9. What time
did the error occur? ____________________________ Do other messages occur in the same
time frame? ________________ Open the 1st error associated with the alarm message. Did you
get useful information for solving the problem? ________________________________________
9. What level of sign in should the average operator routinely use? __________________________
10. Sign in as supervisor. What additional selections do you see when you select the Reagent button?
______________________________________________________________________________
______________________________________________________________________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 41
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APPENDIX 5: CALIBRATION & QC
At the system perform the following:

1. From Start, schedule the following:


ƒ Daily RBL’s
ƒ Calibrate ISE’s (if applicable)
ƒ 1 additional colorimetric assay to demonstrate:
y 2 step process on 1650,1800 & 2400
y 1 step process on 1200
ƒ QC all tests
2. Observe the Test Result Monitor
3. From Request⎝Real Time Monitor Locate the RBL C0101
4. Did all tests requested process? ____________________________________________________
5. Review for marks
6. Locate the calibrators
7. What window did you open to see if your colorimetric calibration passed? ___________________
8. Did your QC work? ______________________________________________________________
9. How do you know?
______________________________________________________________________________
______________________________________________________________________________
10. Can you locate the ISE calibrators on the Test Result Monitor? If not why not?
______________________________________________________________________________
______________________________________________________________________________
11. If calibrating and you have to use a new lot of calibrator what would you need to do or check?
______________________________________________________________________________
______________________________________________________________________________
12. Where would the new information be entered for lot# & exp. date?
______________________________________________________________________________
13. What is the only window used to enter new cal factors?
______________________________________________________________________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 42
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APPENDIX 6: ISE’S
Using your Training Manual or STA at the system :

1. Locate your ISE calibration on the Real Time Monitor. Did it Pass? ________________________
2. How many replicates were done for the High cal? ______________________________________
3. Did you have any precision marks? _________________________________________________
4. What is the range for acceptable slopes? _____________________________________________
5. If you pass accuracy and precision what information will be displayed on the Real Time Monitor?
______________________________________________________________________________

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 43
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APPENDIX 7: SPECIMEN ANALYSIS
At the system perform the following exercise. Refer to the STAÎDaily Op’sÎpg.7

Remember: even if a sample does not have a barcode it can still be run in Barcode Mode. This is
safer, easier& faster.

1. Put in work orders for 5 barcoded samples or use the LIS if available
2. Place the 5 samples on the STT in positions 1-5
3. Start the sample run
4. Observe the Sample confirmation window. Were all 5 samples recognized? ______________
5. Monitor the run on Test Result Monitor
6. Process a STAT
7. After the 5 routines and 1 STAT are processing, Sample PAUSE to…
8. Add 3 more Routine Samples
9. When these next 3 samples have started to process…
10. Order a STAT in Order Entry
11. Sample does not have a barcode
a. SID = pitt-brad
b. K
12. Process the sample
13. Review the results of your run

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 44
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APPENDIX 8: CALIBRATION & QC also reinforces use of the Alarm Log
As the instructor you will need to prepare a calibrator & the system before the trainees arrive.

Calibrator Preparation:
ƒ Over dilute a calibrator using 5 ml instead of 3: Be sure to give them this cal to perform
the exercise
ƒ Prepare or have on hand a properly diluted calibrator

System Preparation:
ƒ If possible, move Probe Wash 1out of position or remove it entirely from RTT1 to leave the
designated position empty
ƒ Exchange R1 & R2 for a given assay (eg. TP), so that the R1 is on RTT2 and vice versa

At the system perform the following exercise. Instruct the trainees to do the following and
troubleshoot the errors as they appear

1. Perform a Barcode scan


2. From Start, Calibrate ISE’s, CO2 and GLU (or any assay using the Chem Cal) and any other daily
RBL’s routinely done. NOTE: this works best for troubleshooting a failed colorimetric calibration if
they only cal 1 color assay
3. Run QC

What to Expect:
1. Errors related to the barcode scan and the misread barcodes for R1 & R2. They will also get errors
saying that R1 & R2 for the assay are not present and that an effective reagent pair does not exist
for that assay.
ƒ They should catch this before they start the cal, but usually don’t.
ƒ Reinforce not to leave the system till they check that the message log is clear
ƒ At this point you want to stress how to use the time frame in the alarm log to get to the
root cause of the last alarm displayed
ƒ Don’t forget to stress this as well as double clicking to get more info
ƒ Explain how they can use Reagent Pause if they catch this error before Samples start to
pick up, otherwise the function becomes unavailable
ƒ Reagent Pause will be available for the 2½ minutes the RRV washes before samples
start to pick up
ƒ If they miss the window of opportunity, they will have to wait up to 6 minutes before
Reagent Pause will become active again.
2. The next problem will be that the calibrators will not pick up and the system will go from Start to
Processing to End.
ƒ Nothing will show on the Test Result Monitor
ƒ System will display SMP LOAD OK
ƒ Error messages will display full stroke error and RTT1 Detergent Empty
ƒ System will transition to STOP

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 45
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APPENDIX 8: CALIBRATION & QC also reinforces use of the Alarm Log

3. Again stress using the alarm log properly. Also demonstrate that when they did their barcode
scan, no error was registered, but the Reagent Inventory window shows that there is 0 volume in
the PW1 wedge.
ƒ Stress need to have these solutions onboard before starting a run for probe washing
and dispensing of contamination sets
ƒ Don’t forget to scroll down to the bottom of the Reagent Inventory Window to check
volumes of wash solutions
ƒ a full stroke error will not register for the missing PW1after a barcode scan because the
positions are hard coded in the software and have no barcode to scan.

4. After these errors are reconciled, have them Restart the calibration. Remember they should be
using the over diluted calibrator.
ƒ ISE’s should pass; view on Real Time Monitor
ƒ Always look at Reagent Inventory for the quickest way to see results of color cal
ƒ CO2 should pass
ƒ The colorimetric cal should fail
5. Stress
ƒ Locating the results on the Real Time Monitor
ƒ What’s different between the calibrations that worked vs those that failed?
ƒ 1st rule in basic troubleshooting is REPOUR & REPEAT, no matter what kind of cal fails
ƒ However, in this case that will not work
ƒ Show use of CalÎView Cal CurveÎRBL Check & Cal Check
ƒ CalÎRBL/Cal History; show different ways to sort and compare data
ƒ Explain the different fields

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 46
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KEYS TO APPENDICES

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 47
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SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 48
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APPENDIX 1: ANALYZER COMPONENTS
Use this view if training 1650, 1800 or 2400

H J E I K F

B A G

Label the following :

1. DPP B
2. SPP D
3. RPP1 F
4. RPP2 K
5. DTT H
6. RRV A
7. DWUD J
8. WUD E
9. Oil Sensors I
10. RTT1 L
11. RTT2 G
12. STT/CTT C

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 49
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APPENDIX 1: ANALYZER COMPONENTS
Use this view if training 1200

D
B

H
E

A C

Label the following :

1. SPP B
2. RPP1 F
3. RPP2 H
4. RRV D
5. WUD G
6. RTT1 E
7. RTT2 C
8. STT/CTT A

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 50
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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1650 identify the solutions

1 2 3 4 5 6

Label the following :

1. ISE Buffer
2. Incubation Bath Oil
3. 0.9% Saline
4. Cuvette Wash
5. Cuvette Conditioner
6. System DI Water Bottle

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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1800 identify the solutions

1 2 3 4 5 6
Label the following :

1. ISE Buffer
2. Incubation Bath Oil
3. 0.9% Saline
4. Cuvette Wash
5. Cuvette Conditioner
6. System DI Water Bottle

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 52
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APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 1200 identify the solutions

1 2 3 4

Label the following :

1. ISE Buffer
2. Incubation Bath Oil
3. Cuvette Wash
4. Cuvette Conditioner

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 53
CH_1200165018002400_customer_secondaryOPGuide_001
APPENDIX 2: SOLUTIONS & REAGENTS
Use this view if training 2400 identify the solutions

1 2 3 4 5

Label the following :

1. ISE Buffer
2. Incubation Bath Oil
3. 0.9% Saline
4. Cuvette Wash
5. Cuvette Conditioner

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 54
CH_1200165018002400_customer_secondaryOPGuide_001
APPENDIX 3: SOLUTIONS & REAGENTS
Depending on the system you are operating answer the following questions:

1. What are some of the functions and features of the DTT (dilution tray)?
ƒ Holds 1:5 diluted sample for colorimetric tests for neat sample and auto dilutions
ƒ Sits in air bath
ƒ 300ul maximum volume
ƒ 120 cuvettes 6/20 segments

2. Reviewing the Reagent Inventory window, after performing a Barcode Scan, which reagents would
you need to replace?
ƒ Reagents with yellow or red highlights
ƒ Reagents with low test volumes

3. Where are Probe Wash 1 & 2 containers located and when are they aspirated?
ƒ 1200: PW1 = #42 PW2 =#43
ƒ 1650 & 2400: PW1 = #47 PW2 =#48
ƒ 1800: PW1= 53 PW2 = 54
ƒ Aspirated at the start of a run from the READY State
ƒ During the dispensing of Contamination Sets
4. List the solutions used during the daily Shutdown Wash 2 and identify their locations on the
system?
Wash Solution 1200 1650 1800 2400
ISE Detergent CTT - 15 CTT - 15 CTT - 15 CTT - 15
DI H2O for ISE NA NA CTT - 16 CTT - 16
10% Cuvette Wash Daily CTT – 49 CTT – 49 CTT – 49 CTT – 49
or 5% PW3 weekly RTT 1&2 – 44 RTT 1&2 – 49 RTT 1&2 – 55 RTT 1&2 – 49
DI H2O CTT – 50 CTT – 50 CTT – 50 CTT – 50
RTT 1&2 – 45 RTT 1&2 – 50 RTT 1&2 – 56 RTT 1&2 – 50

5. What is the most common cause of probe crashes?


ƒ Covers out of place
ƒ Wedges not positioned properly

6. What is the proper dilution for the lamp coolant? 5%

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 55
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APPENDIX 4: OPERATION PANEL
At the system, perform and answer the following:

1. Sign in at the User level.


2. What Menu button is missing at this level? Setup
3. If after adding reagents, performing a barcode scan & starting your run, you notice that the R1
reagent for Glucose is missing. What button would you use to correct the situation? Reagent
Pause
4. What feature will you use to add routine or STAT samples to the STT and how can the feature
be accessed? Sample Pause on the Operation Panel or Membrane Switch on the system
5. Perform a Prime 2 and watch the R1 probe and Wash Station. In what situation would you use
this feature? After a probe crash, probe replacement or investigating assay issues
6. Open the Operator’s Guide. Search for the term flagsÎlist of alarm marks. What would an “s”
mean if seen on a patient result? Short Sample
7. You are running samples downloaded from your LIS. When you start the run, the samples do
not process and the system goes back to READY. Which Menu button would you check to
make sure the communication link is established between the LIS and system? Operation
PanelÎ Host (OFF)
8. Open the Alarm icon. Scroll down till you see a message with a yellow S or red 9. What
time did the error occur? ____________________________ Do other messages occur in the
same time frame? ________________ Open the 1st error associated with the alarm message.
Did you get useful information for solving the problem?
________________________________________
9. What level of sign in should the average operator routinely use? User
10. Sign in as supervisor. What additional selections do you see when you select the Reagent
button?
ƒ Active Test List
ƒ Reagent Information

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APPENDIX 5: CALIBRATION & QC
At the system perform the following:

1. From Start, schedule the following:


ƒ Daily RBL’s
ƒ Calibrate ISE’s (if applicable)
ƒ 1 additional colorimetric assay to demonstrate:
ƒ 2 step process on 1650,1800 & 2400
ƒ 1 step process on 1200
ƒ QC all tests
2. Observe the Test Result Monitor
3. From Request⎝Real Time Monitor Locate the RBL C0101
4. Did all tests requested process? Review the Real Time Monitor for RBL & Calibrators to make
sure tests requested actually processed
5. Review for marks: *, l, h, s etc
6. Locate the calibrators; C0101, C0201 etc
7. What window did you open to see if your colorimetric calibration passed? Reagent Inventory
8. Did your QC work? ______________________________________________________________
9. How do you know?
ƒ Presence of marks (l & h) on Real Time Monitor
ƒ Red background on Daily Precision Control
ƒ CentraLink outside 2 SD color coded
ƒ LIS
10. Can you locate the ISE calibrators on the Test Result Monitor? If not why not? No they do not
appear on the Test Result Monitor (CTT 11 & 12 (serum) CTT 13-14 (urine)), only colorimetric
tests appear.
11. If calibrating and you have to use a new lot of calibrator what would you need to do or check? That
all the new cal factors for the new lot# have been entered on CalibrationÎCalSetup
12. Where would the new information be entered for lot# & exp. date?
CalibrationÎCalSetupÎCtrlCal Setup
13. What is the only window used to enter new cal factors? CalibrationÎCalSetup

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APPENDIX 6: ISE’S
Using your Training Manual or STA at the system :

1. Locate your ISE calibration on the Real Time Monitor. Did it Pass? ________________________
2. How many replicates were done for the High cal? Minimum of 3; Maximum of 8

3. Did you have any precision marks? * signifies precision errors


4. What is the range for acceptable slopes? 45-63
5. If you pass accuracy and precision what information will be displayed on the Real Time Monitor?
The ISE Calibration summary will appear

SUPPLEMENTAL INFO FOR TRAINING PURPOSES ONLY.Refer to product labeling for updated information 58
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