ECi Key Operator Training - Instructor Guide

VITROS® ECi/ECiQ Immunodiagnostic System
Key Operator Training

Instructor Guide
INSTRUCTOR GUIDE VITROS® ECI/ECIQ SYSTEM
TABLE OF CONTENTS
Table of Contents
Module 1: Welcome
Module 2: Hardware Overview
Module 3: Software Overview
Module 4: Reagent Management
Module 5: Daily Maintenance
Module 6: Sample Programming
Module 7: Periodic Maintenance
Module 8: Quality Control
Module 9: Results Review
Module 10: Calibration
Module 11: System Configuration and e-Connectivity®
Module 12: System Troubleshooting
Daily Reviews/Start-Up Exercises
Appendix
Appendix A: MicroWell™ Technology
Appendix B: Immunoassay Calibration Theory
Appendix C: Diagnosing Codes
Appendix D: Intellicheck® Technology
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 1

MODULE 1 WELCOME
Welcome participants in the

lobby.
MODULE 1
Introduce yourself, your

Welcome background, and your time
with the company, etc.
ADMINISTRATIVE
• Accommodations and location of restaurants

Have participants introduce
• Location of rest rooms and cafeteria themselves, including:
name and location of the
• Emergency information: Fire exits and medical emergency response lab/hospital where they
information work, current job, previous
job experience, system
• Health Services: Onsite nurse experience, and reason for
coming to the course, etc.
• Flights, mileage/bag reimbursement, lost luggage
• In the lab: Personal Protective Equipment (PPE), lab coats, safety glasses,
and gloves
Note: Also ask what shift
each participant works,
because those individuals
who work 11 p.m. - 7 a.m.
may struggle somewhat with
the time shift.
Review the administrative

items.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 1-1
VITROS® ECI/ECIQ SYSTEM INSTRUCTOR GUIDE
WELCOME MODULE 1
Review the following COURSE OBJECTIVES

course objectives from the
participant guide. At the end of this module, you will be able to:
• Run the VITROS® ECi/ECiQ System in routine operations using the

onboard Help and all reference materials including Operator’s Guide,
Maintenance and Diagnostics Guide, Quick Guide, and Accessories Guide.
• Handle, load, unload, and store reagents.
• Process patient and QC samples.
• Perform daily, weekly, monthly, and as required system maintenance.
• Program, run, and verify assay calibrations.
• Configure Quality Control (QC) fluids and review and print QC data and
reports.
• Set various configuration options on the system.
• Configure the system to produce reports and results in the desired format.
• Use all VITROS® ECi/ECiQ System reference materials to perform basic

troubleshooting and to diagnose and resolve problems.
1-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
MODULE 1 WELCOME
SKILL CHECKS (STUDENT EVALUATION)

• Practice and lab exercises will be incorporated into several modules and
you will be expected to perform according to the stated objectives.
• Knowledge Checks will be incorporated within certain modules.
• Ortho Clinical Diagnostics will keep a list of participants who have

completed the course.
EXPLANATION OF ICONS IN TRAINING GUIDE
The important icon indicates that special attention should be paid to the
content.
The note icon indicates that supplemental information is included.
Review the classroom

agenda and planned
activities for the week.
MODULE 2 HARDWARE OVERVIEW
MODULE 2
Hardware Overview
MODULE OBJECTIVES Review the objectives for
this module in the participant
At the end of this module, you will be able to: guide.
• Identify and locate the main system components of the VITROS®

ECi/ECiQ System.
• Specify the basic functionality of each component.
• Specify the MicroWell™ sequence through the system.
SKILL CHECK
State that this module takes
approximately 45 minutes to
In this topic, you will complete an exercise and a quiz on the concept of hardware
complete.
identity and functionality.
NOTE: For more information on this topic, refer to the Operator’s Guide:
Chapter 1, Introduction and Chapter 2, System Overview.
HARDWARE OVERVIEW MODULE 2
Provide an overview of SYSTEM CENTERS AND SUBSYSTEMS

the main subsystems and
components of the VITROS® The VITROS® ECi/ECiQ System allows you to access the system and view
ECi/ECiQ System. system operation from four main areas:
Operational Unit
• Load and unload samples, reagents, and supplies.
• Perform sample and assay processing.
System Command Center
• Interact with touchscreen monitor.
• Scan magnetic cards.
Output Center
• Print reports and screen displays.
• Send results and data to a laboratory computer.
Power Unit
• Power on system and reset system.
• View diagnostic status.
• Obtain system’s overall well count.
• Perform computer processing.

Remove the Sample Supply
cover and give an open-
cover demo of the VITROS®
ECi/ECiQ System.
Show the Interlock switches.
Explain the Journey of

MICROWELL™ PROCESSING the Well during assay
processing.
A MicroWell™ assay is processed in the MicroWell™ Incubator.
Recapitulation : In the incubator
9 Mention that sample
5 volumes range from
8 10-80 μL.
3
6
Mention that the assay
incubation range is
approximately 16-75
minutes.
7
1
4
Mention that the Reagent
Well Shuttle delivers the well
10 from the pack.
Point out the SR volume

1 Well Dispense verification by the Universal
2 Sample Dispense Wash Probe.
3 Reagent Dispense
4 Incubation
5 Incubator Well Shuttle
6 Well Wash Explain the incubation is 4.5
7 Signal Reagent minutes after the addition of
8 Incubation SR.
9 Luminometer (Read)
10 Disposal Position
HARDWARE OVERVIEW MODULE 2
Ask participant to complete EXERCISE: HARDWARE IDENTIFICATION

the exercise in their
participant guide. Below is a list which contains the subsystems and components of the VITROS®
ECi/ECiQ System. Your instructor will provide you with a pad of Post-it® notes.
Pair participants to work Write the name of each subsystem and/or component on a separate Post-it®
together at each analyzer note, and place each note in the correct location on the analyzer.
and provide Post-it® notes.
Sample Metering Safety Shield
Once participants have
completed the identification Signal Reagent Load Door
exercise, the instructor will
verify the participants have Auto-Load Station
placed the Post-it® notes in
the proper location on the Reagent Supply
analyzer.
Reagent Metering Probe
Sample Metering
MicroWell™ Incubator
Auxiliary Tip Supply
Main Cover Interlock Switch
Luminometer
Exercise completed satisfactorily:_________________________________
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
Ask participants to complete

QUIZ: HARDWARE MATCHING the quiz in their participant
guide.
For each function listed below, enter the matching letter of the VITROS®
ECi/ECiQ System component listed in the left-hand column.
A. Sample Supply _____1. Aspirates and dispenses the sample

into the MicroWell™.
Answer:
B. Sample Metering Safety Shield _____2. Moves the MicroWell™ into the
Outer Ring of the Incubator.
1. D
C. Auxiliary Tip Supply _____3. Protects the mechanical movement
2. F
of the Sample Metering Arm and Proboscis.
3. B
D. Sample Metering _____4. Aspirates, transports, and dispenses
a precise volume of reagent or diluent to the
4. H
assigned well.
5. A
E. Reagent Supply _____5. Transports Universal Sample Trays
and samples to the Sample Metering
position. 6. C
7. G
F. Reagent Well Shuttle _____6. Holds 20 disposable sample tips,
which are picked up by the Sample Metering
Proboscis during automatic dilution 8. E
processing and automatic reflex processing.
G. MicroWell™ Incubator _____7. Incubates wells and then moves

them into position for addition of UWR, signal
reagent, and well read.
H. Reagent Metering Probe _____8. Holds MicroWell™ reagent packs.
MODULE 3 SOFTWARE OVERVIEW
MODULE 3
Software Overview
• Navigate through system screens using process buttons, mini-buttons, or

their corresponding function keys.
• Calibrate the Touchscreen Monitor.
• Print screens and cancel print requests.
• Identify when a condition code occurs and access the Condition Review
screen.
• Identify severity levels associated with condition codes.
• View possible causes of codes and take appropriate action.
• Use Intellicheck® Monitoring to review system verifications.
• Review Environmental Monitoring to check subsystem status. State that this module takes
complete.
SKILL CHECK
In this topic, you will complete an exercise on interpreting condition review.
NOTE: For more information on this topic, refer to the Operator’s

Guide: Chapter 2, System Overview. Also refer to the Maintenance and
Diagnostics Guide: Chapter 6, Troubleshooting and Chapter 8, System
Diagnostics.
SOFTWARE OVERVIEW MODULE 3
Review the features of the MAIN MENU SCREEN

Main Menu screen and
Status Console.
Mention that the three

operating status messages
are Sampling in Progress,
1 Operating Status
Assays in Progress, and
Assays Completed.
2 System Status
3 Mini-buttons
4 Error count and severity level indicator

Explain the system status
messages include: Ready,
5 Condition Review button
Initializing, Equilibrating
Environment, Diagnostics
6 Date, time, & software version
Mode, Periodic Maintenance,
Dis. Sample Sup, Inop.
7 Sample Processing button
Incubator, and O/R
Luminometer.
8 STAT Processing button
9 Status Console
10 Functional Area
Mention that the
11 Prompt Line e-Connectivity® status
symbol will display if your
12 Process buttons system is configured for data
exchange with OCD.
Point out the Laboratory

Information System (LIS)
symbol will display if the
system is configured to an
LIS.
Demonstrate how to TOUCHSCREEN CALIBRATION

calibrate the touchscreen.
The Touchscreen Monitor and Keyboard are used to navigate through the
system’s screens. The Touchscreen Monitor may be adjusted for optimum
responsiveness to a given individual’s touch.
To calibrate the touchscreen, go to:
Diagnostics > Calibrate Subsystems > Test Touchscreen >

Calibrate Touchscreen
1. Touch each crosshair that is displayed two times.
2. Touch Save.
Demonstrate how to place FUNCTION KEYS

function key labels on
process buttons and navigate Function keys may be used instead of process buttons whether or not function
using the function keys. key labels are displayed.
Ctrl + F12: Places function key labels on the process buttons.
Examples:
• Touch F10 function key on the keyboard to access Help from the current
screen.
• Touch F5 function key to shutdown the analyzer.
KEYBOARD MAPPING TO MINI-BUTTONS Demonstrate how to map

the main function keys to the
Ctrl + associated function key maps to the mini-buttons mini-buttons.
Keys Function
Ctrl + F1 Sample Programming
Ctrl + F2 Reagent Management
Ctrl + F3 Results Review
Ctrl + F4 Quality Control
Ctrl + F5 Periodic Maintenance
Ctrl + F6 Environmental Monitoring
Ctrl + F7 Options & Configuration
Ctrl + F8 Diagnostics
Ctrl + F9 Condition Review
Ctrl + F11 Start/Discontinue STAT Sample Processing
Ctrl + F12 Display Function Key labels on Process Buttons Mention if a screen freeze
occurs, you can begin
sample processing by
touching Ctrl + F11.
NOTE: Ctrl + F11 function key starts or discontinues STAT Sample
Processing.
PRINT REQUESTS
Mention that printing
screens with the Print Screen Most data screens have a Print process button to quickly obtain a
key takes approximately 3.5 paper copy of the information.
minutes per screen due to
the Graphical User Interface
of the system.
If it is necessary to cancel a print request:
• Touch F12 to display the Cancel Print Requests dialog box.

Discuss how to cancel
a print request using the • Select the check box next to the function you wish to cancel.
Cancel Print Requests dialog
box. • Touch Select All to cancel all printing.
NOTE: Patient result reports cannot be cancelled from this screen.
Demonstrate how to access HELP

Help using the following
examples: • Touch F10 or the Help button on any screen to access information related
to the screen displayed.
• A list appears if multiple Help topics are available.

• Daily Maintenance
procedure • Touch Exit or F1 to exit the Help dialog box.
• Sample Metering: • General Help: Contains an alphabetical list of all Help topics.
Program a sample
DIALOG BOXES Navigate to the following

screen:
• A dialog box may appear when specific process buttons are selected.
Quality Control > Review
Data by Analyte > Edit/Add
Comments
• Touch OK, Yes, or F1 to save a selection.
• Touch Cancel, No, or F4 to close the dialog box without saving a

selection.
• Radio buttons appear in list boxes when a single selection is required.
• Check boxes appear next to text in list boxes when multiple selections
can be made. Discuss the Set Filter dialog
box.
Set Filter
• Defines criteria, such as date and time, to limit the information

displayed.
Review Page Up, Page CONDITION REVIEW

Down, Scroll Up, and Scroll
Down navigation keys on the Sensors in the VITROS® ECi/ECiQ System monitor the progress of each sample
Condition Review screen. and well processed. Deviations from normal operation are reported to the
operator by condition codes.
When a condition code occurs, the operator is notified by:
• An audible alert
• A severity level and count posted on the Status Console
• A highlighting of the Condition Review button
Discuss each severity level SEVERITY LEVELS

and give an example:
Severity levels indicate the amount of operator intervention necessary to restore
• Transient: 451-005 normal operation.
• Attention: 506-025 Severity Level Description

Transient No audible tone. Temporary conditions that do not require
• Action: 502-011 operator action and do not show on the Status Console.
• Malfunction: G01-015 Attention A warning. Action may need to be taken soon to resolve.
For example, 6 wells remaining in a reagent pack.
• Shutdown: 451-041 Action Prevents execution of some but not all requests. User
action is required to resolve. For example, when no
wells are remaining in a reagent pack, no further assay
processing is possible until the operator loads another
reagent pack.
Malfunction Intervention will be required to resolve. Typically,
mechanical conditions that prevent the operation of one or
more subsystems.
Shutdown Typically, software malfunctions that require reloading of
the control program, which occurs when the system is
reset.
• Condition code indicators remain on the Status Console until reviewed.
• Shutdown code indicator remains on the Status Console until the system is
reset.
Demonstrate how to access

REVIEW CONDITION CODES and review condition code
messages.
Condition Review
1. Touch Condition Review.
2. Select the code(s) you wish to review.
3. Touch View Description. Mention on the Condition

Review screen, the most
recent code is in bold and the
previous codes are shaded
The View Description screen lists possible causes of and things to do to resolve
grey.
the condition:
• Perform the activities suggested under “Things to do” in the order listed.
• Touch Initialize. The system will attempt to reset all affected subsystems.
Mention that a Field
• Additional condition codes will post if the initialization is unsuccessful. Engineer typically uses
the information under “For
• Condition codes may prompt you to use Intellicheck® Monitoring. Trained Service Personnel”.
The text on the View Description screen may be categorized as specific or

generic:
• Specific: Conditions require text that is unique to that condition.
• Generic: Conditions describe an interruption to hardware component

movement and share common descriptive text on the View Description
screen.
• Use message on Condition Review screen to interpret the directions.
• Actuator refers to the moving component.
• Inspect the path of movement for obstructions.
• Inspect the optical sensor.
Actuator Direction
E00-014 Sample Metering Arm Horizontal, did not

reach Home location, Motor Blocked
Mention to record the

6-character code and print
the View Description screen To view the description for another code:
if it is necessary to call the
Customer Technical Support 1. Touch Enter New Code.
Center.
2. Enter the 6-character code in the dialogue box.
3. Touch OK.
TROUBLESHOOT CONDITION CODES

Elements of condition codes: Mention this diagram is
located under the top cover
• Contain six characters. of the analyzer to use as a
reference.
• The first alphabetic character of a malfunction code indicates the affected
subsystem.
F
A E
H
G
D J
A Reagent Supply
D Sample Supply
E Sample Metering
F Reagent Metering
G Incubator
H Luminometer
J Well Wash
K Signal Reagent
R Supply Center
Examples of condition codes:
• A06 - 051 Reagent Supply Cover is open.
• F00 - 015 Reagent Metering Arm Horizontal, did not reach home
location, Motor Flag Failure.
REVIEW CODES
The Review Condition Codes screen displays a list of condition codes and the
number of times each has occurred.
To access the Review Condition Codes screen:
Condition Review > Review Codes
Condition counts can be displayed by:
• In Condition Review
• Includes codes in the Condition Review list (up to 400).
• Since Last Reset
• Includes codes that have occurred since the last reset (up to 999,999).
Mention that Reset Counts • Reset Counts

does not affect the In
Condition Review list. • Only available when viewing the Since Last Reset list.
• Begins the condition code count at present time.
• Print Summary
• Prints a list of condition codes and counts.
Direct participants to
EXERCISE: CONDITION REVIEW complete the condition
review exercise.
Complete the following exercise as directed below.
1. Verify the analyzer is in Ready status.
a. Open the top cover of your system. Mention the analyzer must
be in Ready status to begin.
b. Record the severity levels and counts posted on the Status Console
resulting from your action.
_______________________________________________________
_______________________________________________________
_______________________________________________________
2. Touch Condition Review.
a. List the following information for the first condition code:
Severity Level: _________________________________
Date/Time: ____________________________________
Condition Code: ________________________________
Message: _____________________________________
b. List the following information for the first condition code on the next
page:
Severity Level: _________________________________
Date/Time: ____________________________________
Condition Code: ________________________________
Message: _____________________________________
3. Touch the first Condition Code on the screen, and then touch
View Description. Review the “Possible Causes” and “Things to do”. Do
not perform the actions at this time.
4. Touch the Help button. Does the information viewed here refer to the
highlighted Condition Code? _____Yes _____No
NOTE: Navigate to the bottom of the screen. Additional Help is located

in the Maintenance and Diagnostics Guide.
5. Exit the Help screen.
Answer: 6. An audible tone sounds for all condition codes except for which severity
level?______________________________
6. Transient
7. Record the first letter in the condition code corresponding to the subsystem
listed below:
Answer: Reagent Metering: __________
7. Control Unit: __________
Reagent Metering: F Sample Supply: __________
Control Unit: Q Sample Metering: __________
Sample Supply: D Reagent Supply: __________
Sample Metering: E Luminometer: __________
Reagent Supply: A Incubator: __________
Luminometer: H 8. Close the top cover and touch the Initialize button. Return to the Main
Menu and verify that all conditions have been corrected and the system has
Incubator: G returned to Ready.
Exercise completed satisfactorily:_____________________________________
Participant:______________________________________________________
Date: _________________________________________________________
Instructor:________________________________________________________
Date:____________________________________________________________
INTELLICHECK® MONITORING Discuss the features of

Intellicheck® Monitoring.
The system uses Intellicheck® Technology to review subsystem verifications and
environmental status throughout sample and assay processing. The Intellicheck®
Technology includes both System Intellicheck and Individual Result Intellicheck.
Intellicheck® Monitoring includes:
• Onscreen and print reports
• Exception detection indication
• Specifications and ranges (process-dependent)
• Acceptable ranges, actual readings, and exceptions displayed in a

graphical format.
Intellicheck® Technology monitors the following subsystems and processes. The

set of verifications performed for each assay varies based on the type of assay.
• Sample Metering
• Reagent Metering
• Well Wash
• Signal Reagent
• Luminometer
To review a subsystem verification, go to: Show each subsystem and

point out how the verification
Intellicheck Monitoring > System Intellicheck changes with each.
• Select a subsystem and a verification to review.
Additional verification buttons include:
• Filter
• Define filter criteria by date range for the verification data displayed.
• Print
• Print the data for the selected verification.
• Help
• Obtain information related to the displayed screen.
Select additional verification buttons to display the following data:
• Graphs containing the number of detected exceptions versus time.
• Total number of verification events and the number of detected exceptions

versus time.
• Volume verification, including detected exceptions versus time.
• Exceptions will be marked in red.
To review an Individual Result Verification, go to:

Show an example of
an Individual Result
Intellicheck®. Results Review > Search/Review Edit > Select a record > Result
Intellicheck
ENVIRONMENTAL MONITORING Discuss the information

displayed on the
To access the Environmental Monitoring screen, go to: Environmental Monitoring
screen.
Intellicheck Monitoring > Environmental Monitoring
Environmental Monitoring screen:
• Gauges that are black show subsystems are in specification.
• Gauges that show red are out of specification.
NOTE: Condition codes will post every five minutes if the system is out-
of-range.
• Start Monitoring will update the gauges every 10 seconds.
• View More Detail displays coil temperature, power supply voltages, and
other subsystem temperatures.
• Help will supply acceptable ranges.
Point out the Reagent

Cooler circuit breaker on the
The Defrost Cycle maintains the Reagent Supply Subsystem humidity: back of the analyzer. If the
circuit breaker is turned off,
• Occurs every two hours for three minutes. the Reagent Supply and Coil
temperature will be out-of-
• Does not interrupt system operation. range.
Direct participants to EXERCISE: INTELLICHECK® MONITORING

complete the exercises on
Intellicheck® Monitoring and 1. Use Intellicheck® Monitoring to:
Environmental Monitoring.
a. Review the five subsystem verifications performed by the analyzer.
b. Record any exceptions that are displayed.
_______________________________________________________
Answers: _______________________________________________________
1.b. Answers will vary. 2. List all types of verifications performed by Sample Metering Intellicheck®.
2. _______________________________________________________
Clot _______________________________________________________
Bubble _______________________________________________________
Short Sample _______________________________________________________
Viscosity _______________________________________________________
Thin Layer Film 3. Display verifications for the Sample Metering subsystem bubble verification:
3.a. Answers will vary. a. What date range is included in the display? _____________________
3.b. Answers will vary. b. Are any exceptions displayed? _____Yes _____No
Answers:
EXERCISE: ENVIRONMENTAL MONITORING
1. What is the Incubator temperature specification for the VITROS®
1. 36-38°
ECi /ECiQ System?____________________________________________
2. Start Monitoring
2. How can you update the gauges every ten seconds?__________________
3. Answers will vary.
3. What is the current coil temperature in the Reagent Supply?
____________________________________________________
MODULE 4 REAGENT MANAGEMENT
MODULE 4
Review the objectives for

Reagent Management this module in the participant
guide.
MODULE OBJECTIVES
At the end of this module, you will be able to:
• Identify information on a reagent pack bar code label. Supplies Needed:
• Store and handle reagents. • Reagent Pack(s)
• Load and unload reagent packs. • Maintenance Pack(s)
• Identify the main components of the Reagent Management screen. • HSDB Pack
• Scan magnetic cards. • Magnetic Cards (5)
• Display inventory on the system. • Instructions for Use

(IFU)
• View expiration dates of reagents.
• MicroWell™ Assay
Summary Chart
SKILL CHECKS State that this module takes

In this module, you will complete exercises on the concept of reagent complete.
management.
Chapter 4, Managing Reagents and Supplies, and the Quick Guide:
Chapter 2, Load Reagents.
REAGENT MANAGEMENT MODULE 4
Discuss the reagent pack REAGENT STORAGE AND HANDLING

storage and handling
requirements.
MICROWELL™ REAGENT PACKS:
• Store refrigerated at 2-8° C. Do NOT freeze.

Refer to MicroWell™ Assay
Summary Chart or IFU • One or two bottles of reagent.
(Instructions for Use) per
assay for open reagent pack • Four tubes of 25 wells (total of 100 wells).
stability.
NOTE: Some packs may contain a total of 52 wells.
• No reconstitution necessary.
• Load directly from refrigerator.
• Do not mix. Avoid agitation, which can cause bubbles in the reagent bottles.
• 8-week or 12-week open stability, depending on the assay.
• If you remove an opened reagent pack from the system, store the pack in a
VITROS® Reagent Storage Box with desiccant in the refrigerator.
• Reagent Supply subsystem maintains 20 reagent packs at 4-8° C and

<40% relative humidity.
Mention availability of • Refrigerated ready-to-use diluents include:

Manual High Sample A and B
in bottle form. • High Sample Diluent A
• High Sample Diluent B
• Ancillary Pack (for example, P3 B12/Folate)
Discuss the information on a

REAGENT LOT NUMBER reagent bar code label.
The 11-digit Reagent Pack Lot Number is found next to the bar code on the
reagent pack label.
• The first three digits identify the assay and remain the same from lot to lot Explain the 11-digit reagent
within the assay. pack lot number.
• The middle four digits are called the Lot Number and signify that all reagent
packs of the assay with this lot number should perform the same.
• The last four digits are unique for each pack and allow the system to track: Mention that the
ECi/ECiQ System uses a
• Open expiration of the pack. linear barcode and the 3600
system uses a 2-D barcode.
• Pack loading and unloading.
• Example: Reagent Pack Lot Number: 004 0024 1244 Mention that the Reagent
Pack Lot Number in the
• Assay ID: 004 example is for an FT4 assay.
• Lot Number: 0024
• Pack ID: 1244
LOAD AND UNLOAD REAGENT PACKS

Reagent packs can be loaded automatically or through the Unload/Load button
located on the View by Reagent screen.
AUTOMATIC LOAD
Point out well count and
reagent level determination
is performed after each NOTE: Reagent packs may be loaded at any time, except when the
reagent pack is loaded system is in Diagnostics Mode or the Reagent Supply is initializing.
during automatic loading.
To load reagent packs automatically:
1. Verify that the LED at the Auto-Load Station is green.

Mention that an amber-
colored LED indicates a “Not 2. Open the Outer Load Door and verify the Reagent Pack Shuttle is visible.
Ready” status or the Reagent
Supply is initializing. • The shuttle will not be visible if the Reagent Supply is full.
3. Place the reagent pack directly on the Reagent Pack Shuttle.
4. Load additional packs, one at a time, and then close the Outer Load Door.
NOTE: Well count and reagent level determination of the pack occurs
immediately, except when another reagent pack is being accessed
during processing.
SOFTWARE LOAD Point out multiple packs can

be loaded using Unload/
To load reagent packs using Unload/Load: Load before the system
counts wells and determines
1. Touch Reagent Management. the reagent levels of each
pack.
2. Verify that the LED at the Auto-Load Station is green.
3. Touch Unload/Load.
NOTE: Empty packs will unload first.
4. Open the Outer Load Door.
5. Load the reagent pack, and then close the Outer Load Door.
6. Repeat steps 3-5 to load additional packs.
7. Touch Return.
• Well count and reagent level determination will begin. Mention that unload status
will display “Unloaded”,
“Unloading”, or “Waiting”.
To unload reagent pack(s):
1. Touch Reagent Management.
2. Select the assay button(s) to identify the pack(s) you want to unload.
3. Touch Unload/Load.
• Selected packs are unloaded first, followed by empty packs.
4. Unload status will display “Unloaded”, Unloading”, or “Waiting”.
5. If necessary, touch Stop Unload to stop the unload process.
Discuss the information REAGENT MANAGEMENT SCREEN

available on the Reagent
Management screen for each
pack loaded.
The Reagent Management screen displays views for each pack loaded:
• Well Count: Displays the number of wells in each reagent pack.
• Lot No.: Displays the reagent lot number.
• Pack ID: Displays the pack ID for the reagent pack.
• Pack Status: Provides status for each reagent. (See next page for pack
status views.)
For additional information, select the following process buttons:

Mention the Print process
button.
Lot/Pack Detail Displays the following: date the pack was opened
and the shelf or open expiration date for each
reagent pack.
View Supplies Displays Signal Reagent inventory and expiration
date(s). Displays Universal Wash Reagent (UWR),
solid waste, and liquid waste inventory levels.
Unload/Load Unloads a reagent pack and loads multiple packs.
PACK IDENTIFICATION MESSAGES Demonstrate how to load

a pack by entering reagent
• Bar Code?: Bar code is unreadable. Touch Bar Code? and manually enter pack lot number manually.
the reagent pack lot number.
• Lot Card?: No information supporting the lot is available. Scan the

Reagent Lot Calibration Card (green).
• ?: The pack bar code matches that of a pack already loaded. Unload the
pack.
PACK STATUS VIEWS Discuss the pack status

views that are available.
“Ready” status is required for assay processing. Otherwise, one of the following
pack status views may display:
• Ready: Reagent is ready for use in assay processing.
• In Use: Reagent is being used or is reserved for assay processing.
• Not Cal: Reagent lot does not have a current calibration.
• Empty: Well count is 0, or insufficient reagent in the reagent pack. Explain that if Empty status
displays and the well count is
• Inv?: Inventory is under way or incomplete. not 0, this may indicate there
are bubbles or foam in the
• Protocol?: Scan the Protocol Card (blue). reagent bottle.
• Lot Card?: No information supporting the lot is available. Scan the
Reagent Lot Calibration Card (green).
Discuss the components of REVIEW INVENTORY

the Lot/Pack Detail screen.
The system monitors the inventory and status of each reagent pack, Signal
Reagent, Universal Wash Reagent, Liquid Waste, and Solid Waste. Several
screens provide information about reagent inventory.
To review inventory, go to:
Reagent Management > Lot/Pack Detail
The Lot/Pack Detail screen displays the date the reagent pack was opened and
the date it will expire.
• Expiration Dates:
• Shelf Expiration: Expiration date on the reagent pack.
• Open: Date and time pack was loaded.
• Expiration: Date and time for open, on-system stability.
To review calibration expiration, go to:
Reagent Management > Lot Pack/Detail
View by Displays wells available for dilution and calibration

Assay expiration.
The number in the dilution column of the View by

Assay screen is dependent on the reflex dilution factor
configured in Options & Configuration.
View by Displays Signal Reagent, Universal Wash Regent,
Supplies Liquid Waste and Solid Waste levels.
• Dates shown in yellow, indicate expiration is

within 48 hours.
• Dates shown in red, indicate reagent has

expired.
MAGNETIC CARD SCANNING Point out that changes in

protocol or troubleshooting
Scan magnetic cards to upload the information contained on the card to the procedures may require you
system. to rescan the protocol card.
Protocol Cards (blue):
• Once per assay, unless change in protocol.

Show an example of each
• The assay button will not appear on any screen unless a protocol card has
magnetic card.
been scanned.
• Contains assay processing information including:
• Incubation time
• Sample and reagent volumes
• Wash protocols
Reagent Lot Calibration Card (green):
• When a new lot of reagent is loaded
• Once per lot number
• Contains lot specific information including:
• Master calibration information
• Calibrator concentrations
• Dynamic Range
• Expiration date of the lot
Maintenance Pack Lot Card (orange)
High Sample Diluent A or B Reagent Lot Card (white)
P3 B12/Folate Lot Card (yellow)
Demonstrate how to scan a TO SCAN A MAGNETIC CARD:

magnetic card.
1. Verify the Magnetic Card Scanner LED is green.
2. Scan one stripe of the card through the scanner.
a. Verify that the stripe is facing you.
3. When the LED is blinking green, scan the second stripe of the card. You
must scan the second stripe of the card within ten seconds of the first
stripe.
Mention you may need to

scan an additional card for
B12 and Folate.
NOTE: If the LED continues blinking green, you may need to scan an
additional card.
4. When both sides of the card are scanned successfully, the LED returns to
solid green.
UNSUCCESSFUL SCANS:
• If the stripe was not read successfully, an attention code is displayed.
• If one stripe fails to scan, rescan both stripes.
• If the same side of a card is scanned twice, the LED remains blinking
green.
• If the second stripe is not scanned within 10 seconds of the first, the LED
displays a solid green light. Rescan both sides of the card.
EXERCISE A: REAGENT MANAGEMENT complete the Reagent
Management Review
Complete the exercise below as directed. Exercise A.
1. Scan the Lot Card provided by your instructor.
2. Unload a reagent pack and then reload the same reagent pack.
Ask participants to use
3. Record the following information: either Automatic Loading or
Unload/Load to reload the
a. Current well count for HBsAg:_________________________ pack in question 2.
b. Current TSH Lot #:__________________________________
c. Pack ID for the TSH reagent pack currently loaded on your system:
______________________________
d. Open date and open expiration date of the B-hCG pack:
______________________________
e. Shelf expiration of the current lot # of TropI: ______________
4. Print a copy of the information for all loaded reagents.
5. Unload the HBsAg reagent pack from your system.
6. A reagent pack that was not selected unloads. Please note below the
reason why this could occur.
___________________________________________________
7. Record the test name and 11-digit lot number for each reagent pack in the Answer:
Reagent Management Exercise Kit:
6. Pack has a status of
a. Pack 1:_____________________________________ Empty.
b. Pack 2:_____________________________________
c. Pack 3:_____________________________________
d. Pack 4:_____________________________________
8. Display the View by Reagent screen on the touchscreen monitor. Load

reagent packs 1 and 2 into the system. Do NOT continue with this exercise
until the reagent pack status is complete.
a. Is Reagent Pack 1 available to process assays? _____Yes _____No
b. Is Reagent Pack 2 available to process assays? _____Yes _____No
c. What is the pack status of Pack 1?_________________
d. What is the pack status of Pack 2?_________________
e. Why was Pack 2 given a status of empty?_______________________
9. Load Reagent Pack 3.
a. Identify this pack manually by touching the assay button. (Refer to

information recorded in question 7.a.)
10. Load Reagent Pack 4.
a. What action would you take to address this condition?
_______________________________________________
11. Unload Reagent Pack 3 and Reagent Pack 4.
a. What packs were listed for removal on the Unload/Load screen.
_______________________________________________
b. Why?________________________________________
12. Use the lot number recorded in question 7.a. to remove Pack 1 from the
system, if necessary.
13. Reload the HBsAg Reagent Pack removed in question 5.
SIGNAL REAGENT PACK STORAGE AND HANDLING
SIGNAL REAGENT PACKS:
• Store refrigerated at 2-8° C. Point out that SR bottles (A

and B) contain Luminol and
• Liquid, ready-to-use. No reconstitution necessary. enhancer.
• Do not mix or agitate.
• Warm to room temperature for 45 minutes prior to use.
• Seven-day stability, determined at the time of loading onto the Signal

Reagent (SR) Carousel.
• Two-bottle configuration (A and B) of the signal reagent pack keeps

reagents separated until dispensed into the wells to prolong stability of the
reagent.
LOAD/UNLOAD SIGNAL REAGENT PACKS

• Signal Reagent Packs may be loaded at any time, except when the system
is in Diagnostics Mode.
• When the in-use pack of SR is empty, the system automatically rotates a

new SR pack from the Load Position to the In-Use position.
IMPORTANT: Do NOT load a previously opened pack on the Signal

Reagent Carousel.
• Status of Signal Reagent Carousel:
• In-Use: The pack currently being used for assay processing.
• Load: The position to exchange an empty pack for a new pack.
NOTE: The Load Position may also hold an empty pack waiting to be
removed.
The Pack Present Sensor monitors pack loading:
• Once a pack is loaded, inventory is set to 210.
• A condition code will be displayed if:
Mention that SR countdown • SR assay count is getting low or is 0.

begins at 50 assays.
• SR expiration is within 48 hours.
To load Signal Reagent Packs:
1. Open the Signal Reagent Load Door.
2. Remove the used pack, if present, from the Load Position and then load a
new pack at the Load Position.
Discuss how the system 3. An action code is posted for the operator to verify that the SR pack is new.
automatically rotates a full
SR pack in the Load Position 4. Close the Signal Reagent Load Door.
to the In-Use position when
the In-Use pack is empty. 5. To place a new SR pack in use, touch Reagent Management > View
Supplies > Exchange SR > Yes.
6. If shelf expiration is less than seven days, you can edit the Signal Reagent
Expiration Date.
Demonstrate how to edit the
SR expiration date. Edit the SR Expiration Date:
• A seven day expiration date is automatically assigned when a pack is

placed in the Load Position.
Mention that following the • If the pack shelf expiration is less than seven days, enter the pack
Prime and Purge function, expiration date manually.
when the SR pack is moved
to In-Use, the assay count is
updated to 205.
Point out that routine

scheduled Prime and Purge
functions use five assays of
SR.
UNIVERSAL WASH REAGENT (UWR) STORAGE AND

Mention replacing the
HANDLING Universal Wash Reagent will
be discussed during daily
Universal Wash Reagent: maintenance.
• Used to wash MicroWells™ and the Reagent Metering Probe.
• Store at room temperature. Do not freeze.
• Protect from light during storage.
• Ready for use.
• 12-week on system stability. Explain that if running

Hepatitis tests, the volume
• Sufficient volume for approximately 450 assays, depending on the assays may be only 350-375 assays.
being processed.
Refer to the MicroWell™ DILUENT STORAGE AND HANDLING

Assay Summary Chart for
dilution protocol for each Diluent Packs:
analyte.
Reagents for onboard dilutions:
• Store refrigerated at 2-8° C.
• Ready for use.
Refer to IFU (Instructions for • High Sample Diluent A Reagent

Use) for maximum dilution
factor. • High Sample Diluent B Reagent
• 8-week on system stability.
• Magnetic Card (white) - Scan card for new lot numbers.
Reagents for off board dilutions:
• Ready for use.
• High Sample Diluent A Manual
• High Sample Diluent B Manual
• The background concentration for each analyte is given in the diluent

package insert.
• Result must be recalculated with the background concentration for an off-

board dilution.
EXERCISE B: REAGENT MANAGEMENT Direct participants to

complete the Reagent
Complete the exercise below as directed. Management Review
Exercise B.
1. Record the expiration date of the signal reagent pack currently loaded on
the system._______________________________
2. How many assays remain for the In-Use signal reagent pack?
_____________________________
3. Load a new signal reagent pack provided by your instructor and then
exchange it into the In-Use position. What is the status of the pack that was
previously in the In-Use position? _______________________________
4. Remove the signal reagent pack previously in the In-Use position and
return it to your instructor.
5. Record the expiration date for the signal reagent pack that you just loaded.
__________________________
6. Can the signal reagent pack, which was originally in the In-Use position and
which you unloaded in Step 3 above, be reloaded and used as a valid SR
pack since it is not empty? _____Yes _____No Answer:
7. Record the following levels displayed on the View Supplies screen: 6. No
a. SR count for In-Use:_______________________________
b. Wash Reagent:___________________________________
c. Solid Waste:_____________________________________
d. Liquid Waste:____________________________________
Exercise completed satisfactorily:___________________________________
Participant:_____________________________________________________
Date:__________________________________________________________
Instructor:______________________________________________________
Date:__________________________________________________________
MODULE 5 DAILY MAINTENANCE
MODULE 5
Daily Maintenance
• Locate the Periodic Maintenance screen and review the daily maintenance
procedures.
• Perform the daily maintenance procedures specified. Supplies Needed:
• Kimwipes®
NOTE: You can see an example of a daily maintenance log at the end
of this module. • 70% isopropyl alcohol
• Deionized water
SKILLS CHECK
In this topic, you will complete a daily maintenance exercise.
approximately one hour to
NOTE: For more information on this topic, refer to the Maintenance and complete.
Diagnostics Guide: Chapter 1, Operator Maintenance and Chapter 2,
Daily Maintenance.
DAILY MAINTENANCE MODULE 5
Note where participants can LOG LOCATION

print daily maintenance logs.
Maintenance Logs can be printed from:
• www.orthoclinical.com
• Maintenance and Diagnostics Guide
• Instructions for Use (IFU) CD
Review daily procedures on DAILY MAINTENANCE

the Maintenance Log with
participants. To view the Daily Maintenance procedure list, touch Periodic Maintenance >
Daily Maintenance.
NOTE: Maintenance procedures are available through the onboard

Demonstrate how to access Help menu.
the various maintenance
procedures lists.
PERFORM THE FOLLOWING PROCEDURES DAILY:
• Empty Solid Waste Container and Liquid Waste Bottle.
Review Daily Maintenance
procedure protocols following
proper safety procedures.
NOTE: You may need to empty the Solid Waste Container more than
once a day.
Point out the system reports

a condition code when the • Remove outdated and empty reagents.
waste containers approach
full or are full. • Clean the Signal Reagent Probe Assembly. Use a Kimwipe® or a lint-free
cloth moistened with 70% isopropyl alcohol.
The solid waste container
holds 350 tips and 500 wells. • Inspect and clean the Universal Sample Trays and Micro-Collection
Container Adapters with isopropyl alcohol or a Kimwipe® moistened with
Single-use solid waste water.
containers are available.
• Verify inventory and load reagents.
• Verify that QC fluids have been processed.
MODULE 5 DAILY MAINTENANCE
Recommended:
• Verify the Auxiliary Tip Supply is full.
• Load tips on the exposed portion of the Auxiliary Tip Supply.
IMPORTANT: Do not load when the top cover is up.
• Select Sample Programming Options > Options > Rotate Aux Tip
Supply.
EXERCISE: PERFORM DAILY MAINTENANCE Ask participants to

perform daily maintenance
Using the Periodic Maintenance screen and the Daily Maintenance log at the following the procedures as
end of this module as a guide, perform the required daily maintenance on the demonstrated in this module.
VITROS® ECi/ECiQ System.
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
Maintenance Log VITROS®ECi/ECiQ Immunodiagnostic System
Month/Year System J Number System Serial Number

Day
Daily—Check (✔) Boxes 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
Empty:
t4PMJEXBTUFDPOUBJOFS
t-JRVJEXBTUFCPUUMF
Remove outdated and empty:
t3FBHFOUQBDLTBOE43QBDLT
t6OJWFSTBMXBTISFBHFOU
Clean the signal reagent probe assembly
Inspect:
t6OJWFSTBMTBNQMFUSBZT
t.JDSPDPMMFDUJPODPOUBJOFSBEBQUFST
Verify inventory and load:
Verify that QC fluids have beenprocessed
Operator’s Initials
Weekly—Date/Initial Boxes Week 1 Week 2 Week 3 Week 4 Week 5 Monthly—Date/Initial Boxes Date Initial
Clean the sample metering proboscis Back up QC, calibration, and configuration files
Clean the tip disposal chute/cup retainer Inspect the reagent cooler filter
Every two months:
Clean the sample supply subsystem Change the vapor adsorption cartridge
Every three months:
Clean the touchscreen monitor Change the universal wash reservoir filter
Clean the keyboard and keyboard cover "T3FRVJSFE%BUF*OJUJBM#PYFT Date Initial

Perform subsystem cleaning Clean the system cabinetry
Clean the processing center
*May require emptying more frequently depending on usage.
Reviewed by _____________________________________________________ Date _____________________________

Version 2.0
MODULE 6 SAMPLE PROGRAMMING
MODULE 6
Sample Programming
MODULE OBJECTIVES
Review the objectives for
At the end of this module, you will be able to: this module in the participant
guide.
• Set up Universal Sample Trays.
• Specify minimum fill requirements for sample containers.
• Identify the main components of the Sample Programming screen.
• Differentiate sample programming methods, and select those appropriate Supplies Needed:
for your laboratory.
• Patient fluids
• Program assays and dilutions and enter patient demographics.
• Universal Sample
• Edit and delete programming via the System Command Center. Trays
• View downloaded messages. • Sample containers
• Create, edit, and delete panels.

• Add tips to the Auxiliary Tip Supply. approximately two hour to
complete.
• View the status of samples in progress.
SKILL CHECKS
In this module, you will complete exercises on the concept of sample
programming.
Chapter 6, Preparing Samples and Chapter 7, Programming Samples.
SAMPLE PROGRAMMING MODULE 6
PREPARE SAMPLES FOR PROCESSING

• Refer to Instructions for Use (IFUs) for each assay for specimen
preparation.
• Universal Sample Trays:
• Tray ID number and bar code
• 10 sample positions per tray
• Disposable Tips
• Built-in height adapter for 75 mm and liquid calibrator tubes
• Tubes supported using the Micro-Collection Container Adapter

Explain how to use Table
6-2, “Minimum Fill Volumes”, • Tube Diameter Flags - spring clip holds and identifies tubes of
on page 6-8 of the Operator’s assorted diameters.
Guide.
• Minimum fill requirements are dependent on sample container and assays
processed.
Discuss the main features SAMPLE PROGRAMMING SCREEN

of the Sample Programming
screen.
Sample ID 1-15 alphanumeric characters

Must be unique
Mention when to select
Sample Type Patient, Control, Cal sample type.
STAT Priority processing
Perm Permanently programmed Sample ID or Tray ID

Typically used for QC
Rept Sample program is assigned verify repeat status for Discuss the Usage Inventory
Usage Inventory Report
Report.
Patient Type Assign a patient category: Inpatient or Outpatient
Body Fluid Identifies specimen type: serum, plasma, urine, other
Special 1-9 alphanumeric characters

Used to indicate an unsupported body fluid is processed
on another body fluid protocol
Manual Dil Operator performed dilution

Results are multiplied by this factor
Assay Dil Automatic onboard dilution

Configurable default dilution may be overidden during
programming
+R or -R Increases or decreases assay or panel replicates
View Graphic: Visual representation of tray

Text: List of Sample IDs for tray
Assays Analytes supported on your system
Panel Predefined grouping of assays
Sample Volume Total volume of sample needed to process selected tests

Does not include minimum fill requirement
Wells Required Number of assay wells required to process the sample

Maximum of 20 assays may be programmed per sample
Explain the function of PROCESS BUTTONS

the process buttons on
the Sample Programming Edit Pat Add, edit, or display patient demographics.
screen. Data
Override report defaults using Set Report
Status.
Save/Next Saves the program.
Displays the next tray position in graphic view.
Cancel Resets the program to last time Save/Next

Changes was selected.
Batch Assigns sample IDs and tray positions for

Save batch programming.
Options Define Panels, Review Tray IDs, Review

Sample IDs, Review Downloaded Messages,
and Rotate Auxiliary Tip Supply.
Edit Tray Add unassigned samples to trays.
Programs
Remove samples from trays.
Delete unassigned Sample IDs.

Delete Delete programmed samples or trays.
Review/ Request, edit, or review auto dilutions.

Edit
Dilutions Add or delete dilution replicates.
SAMPLE PROGRAMMING METHODS
OVERVIEW
• Up to 10,000 programs can be stored in memory:
• 9,000 pending samples can be downloaded.
• 1,000 pending samples are available for STATs programmed through

the keyboard.
• The sample programming methods include: Downloaded Requests, Tray

ID, Sample ID, Processing Unassigned Samples, and Batch Programming.
DOWNLOADED PROGRAMMING Mention Sample Program

downloads occur using
• Sample Programs transmitted from a Laboratory Information System (LIS). Broadcast Download not
Host Query.
• Up to 9,000 programs may be entered into a Laboratory Information
System (LIS) and downloaded to the ECI/ECiQ system.
• Programming remains in the ECi/ECiQ system’s memory until matched to

the specimen Sample ID via a bar code, or by assigning a tray position in
which the sample will be processed through the keyboard. Mention there are two
LIS Protocols: Kermit and
• Downloaded programs may be edited at: ASTM. Go to Options &
Configuration > Configure
• LIS - Programming must be downloaded again. Ports.
• ECi/ECiQ - Cannot be further edited at the LIS.
Discuss how to process a LAB COMPUTER INTERFACE STATUS

STAT sample.
Status symbols displayed on the Status Console under LIS:
Sample Programming is being downloaded from the

LIS to the ECi/ECiQ System.
Assay results are being uploaded from the ECi/ECiQ
System to the LIS.
A STAT has been downloaded but not yet reviewed
through Sample Programming > Options.
A message regarding downloaded programming is
waiting for review through Sample Programming >
Options > Review Download Messages.
See Table 7-1 on page 7-38 NOTE: The Download Message and STAT symbols remain in the
of the Operator’s Guide for a Status Console until the information has been reviewed through Sample
complete listing of download Programming Options.
messages.
REVIEW DOWNLOAD MESSAGES
Sample Programming > Sample Programming Options >

Review Download Messages
PROCESSING BAR CODED SAMPLES complete the exercise in the
lab.
Complete the sample programming exercise as directed below.
1. You will be provided with bar code-labeled tubes to process downloaded

sample programs.
2. Place the tubes on a Universal Sample Tray. Mention samples that are
not bar coded and all STAT
3. At the sample prep bench, place a VITROS® MicroSample Cup on top of samples must be assigned a
each tube. tray position for processing.
“Processing Unassigned
4. Pipette about 200 μL of “patient sample” into each cup. Samples” will be discussed
in this module.
5. Check for air bubbles.
6. Place the tray into the Sampling Center in the appropriate position and
touch Sample Processing.
Discuss the Six Tray rule.
Explain how to remove a

tray from Sample Metering
position using the STAT
Processing button.
Show participants View

Sample Status and View
Sample Detail in Results
Review while samples are
processing.
You will discuss these

features in the Results
Review topic.
Demonstrate the various MANUAL PROGRAMMING METHODS

manual programming
methods.
TRAY ID PROGRAMMING
Use this method to assign sample programs to trays when samples are not bar
coded and assays must be assigned.
• Tray IDs must match the bar code number of the tray used for processing
the samples.
• Sample IDs must be unique. Once all results are complete for a given
Sample ID or the sample program has been deleted, you can reuse the
Sample ID.
• STAT samples must be assigned to a tray and processed using the STAT
Processing button to assign priority.
Mention that additional To process samples using Tray ID Programming:

characteristics include: STAT,
replicates, patient type, 1. Touch Tray.
dilutions, etc.
2. Enter the Tray ID and press Enter.
3. Enter the Sample ID (1-15 characters) and press Enter.
4. Select the appropriate fluid (serum, plasma, urine, or other).
5. Select the assays or panels to be processed for the sample.
• Optional: Touch Edit Pat Data to add patient demographics.
6. Touch Save/Next.
7. Repeat Steps 3-6 to program additional samples for the tray.
NOTE: Additional characteristics that may be programmed include:

STAT, replicates, patient type, dilutions, etc.
SAMPLE PROGRAMMING SYMBOLS
View: Graphic
4 6
7 5
8 4 1
Tray 7
9 3
10 2
1 5
U
1 Patient Sample Programming for the tray position includes assays

and a Sample ID.
2 Unnamed Sample Assays have been programmed, but no Sample
ID was given for the specimen to be run in the tray
position.
3 STAT Sample Sample has priority status.
Assign a tray location for processing.
STAT Processing alerts system to look for a STAT.
STAT samples are processed in the order they are
found.
4 Quality Control Sample ID has been defined for quality control.
5 Calibrator ID has been defined for calibration.
View: Text Demonstrate how to view

text.
• Displays the Sample ID and required volume for samples; not dead volume.
• Identifies STAT programming in the margin.
Mention patient PATIENT DATA

demographics will be
downloaded by the LIS. If the The Edit Patient Data screen includes the following optional information:
LIS is down, you may need
to enter patient information • Patient’s name and comments: Displays on the Patient Report.
manually.
• Patient name can be downloaded and uploaded to the LIS.
• Birth Date and Collection Date: Must be entered using four characters for
the year (for example, 2009).
Mention you may also enter
• Age: Calculates automatically when birth date is entered.
physician information.
• Comments: Each field may contain from 1 to 20 alphanumeric characters.
• Text does not wrap from one line to the next.
• Touch Enter to move to the next line.
SET REPORT STATUS
• Overrides the report defaults set in Options & Configuration for the
sample currently programmed.
• Send: The report is transmitted.
• Off: The report is not generated.
• Defer: The report will be printed or sent at a later time.
SAMPLE ID PROGRAMMING Demonstrate how to

program samples using
• Use this method to create sample programs to be placed on trays and run Sample ID Programming.
at a later time; the samples have not arrived in the lab.
• This method is also useful if using pre-printed bar codes when the LIS is
offline. In this case, assigning the sample to a specific tray position is not
required.
• If using bar codes, the Sample ID must match the number on the bar code
label; include leading zeros.
To process samples using Sample ID Programming:
1. Enter the Sample ID (1-15 characters) and press Enter.
3. Select the assays or panels to be processed for the sample.
• Optional: Touch Edit Pat Data to add patient demographics.
4. Touch Save/Next.
5. Repeat Steps 1-4 to program additional samples.
Demonstrate how to
program unassigned PROCESSING UNASSIGNED SAMPLES
samples.
• Use this method to program samples without bar codes. Assign the
sample(s) to a specific tray position for processing.
To program unassigned samples:

Point out you can also
assign a tray position from 1. Touch Edit Tray Programs from the main Sample Programming screen.
the Sample Programming
screen: 2. If necessary, touch Set Filter to sort the list of unassigned samples by
selected criteria.
1. Enter a Tray ID.
3. Touch Tray and enter an ID.
2. Type a known unas-
signed Sample ID and 4. Select the Sample IDs to be processed.
press Enter.
5. Touch Add to Tray.
3. Touch Save/Next.
• Programming is added to the tray in alphanumerical order.
Demonstrate how to remove

NOTE: Touch Remove from Tray to remove a Sample ID from a tray.
Sample IDs from a tray.
BATCH PROGRAMMING Demonstrate how to

program samples using
• Used to save time in defining identical programming for a group of samples. Batch Programming.
• Patient demographics entered in Batch Programming will apply to all

samples in the batch.
• Alternate Sample ID fields may be selected before typing by touching a

selected line.
To process samples using Batch Programming:
2. Select the assay(s) or panel(s) to be processed for the samples.
• Optional: Touch additional characteristics (for example, STAT,

replicates, patient type, dilutions, etc.).
3. Touch Batch Save.
4. Enter a Tray ID to assign programming to the tray.
5. Touch the tray positions that are not used for this batch.
6. Enter the Sample IDs.
7. Touch Save or OK.
NOTE: Touch Save to clear the Batch Save dialog box so that you
can program additional trays of the same batch. Touch OK to save the
programming and return to the Sample Programming screen.
Direct participants to EXERCISE A: SAMPLE PROGRAMMING

complete the sample
programming exercise. 1. Program and run the following tray using Tray ID programming.
Tray ID Sample ID Assays Sample/Patient Data

3 3001 B-hCG Baker, Mary
3002 TSH Dr. Ben Casey
3003 TropI collection time: 6:30 a.m.
3004 FT4 Birth Date: 05/05/1963
3005 HBsAg Chauncey, Richard
2. Program the following samples using Sample ID programming.
Sample ID Assays Sample/Patient Data

1001 TSH, FT4
1002 FSH
1003 HBsAg
1004 B-hCG STAT, dilute x2
1005 TropI 2 replicates
1006 TSH, FT4 3 replicates, TSH
NOTE: Do not run these samples at this time.
3. Samples 1003, 1005, and 1006 have arrived in the laboratory.
a. Touch Edit Tray Programs.
b. Enter “2” for Tray ID.
c. Locate and select the three sample IDs.
d. Touch Add to Tray.
e. Touch Sample Processing, if necessary.
4. Sample 1004 has arrived in the laboratory.
a. Add sample 1004 to Tray 1.
b. Run the sample as a STAT.
5. Additional assays have been requested for the following samples. Edit the
following Sample IDs to include the assays requested.
Sample ID Assays
1002 B-hCG
3002 FT4
6. Program the following tray using Batch Programming.
Tray ID Sample ID Assays

5 5001 FT4, TSH
5002 FT4, TSH
5003 FT4, TSH
5004 FT4, TSH
5005 FT4, TSH
NOTE: Do not run these samples at this time.
Exercise completed satisfactorily:__________________________________
Participant:____________________________________________________
Date:_________________________________________________________
Instructor:_____________________________________________________
Date:_________________________________________________________
Discuss the main features SAMPLE PROGRAMMING OPTIONS

of the Sample Programming
Options screen. Define Define groups of assays to run together.
Panels
Review Search, review, and delete programs by

Sample IDs Sample ID.
Auto-Delete old sample programming.

Review Review and delete pending Tray IDs.
Tray IDs
Review Display status messages for sample

Download programming downloaded from LIS.
Messages
Rotate Aux Rotates the Auxiliary Tip Supply one full rotation
Tip Supply to allow disposable tips to be added.
DEFINE PANELS Explain that a panel is

a predefined grouping of
To define a panel, go to: assays.
Sample Programming > Options > Define Panels
1. Select the appropriate fluid (serum, plasma, urine, or other). Mention that operators can
configure up to 15 panels per
2. Select one of the 15 configurable panel buttons. body fluid.
3. Enter a panel name, containing no more than five characters, and press
Enter.
4. Select the assays to be included in the panel.
5. Touch Save Panel to store the panel in memory.

Demonstrate how to set
up a ERHCG panel using
DELETE PANELS Review/Edit Dilutions.
To delete a panel:
1. Select the appropriate panel.
2. Touch Delete.
3. Touch Yes in the Delete dialog box to confirm the deletion. Mention that when you
delete a panel, the panel
name reverts back to the
default name.
REVIEW AND DELETE SAMPLE PROGRAMMING
To review Sample IDs or Tray IDs, go to:
Sample Programming > Options > Review Tray IDs > or Review
Sample IDs
Explain that it is important To delete specific Tray IDs that have not been processed:
to delete trays prior to
calibration. 1. Touch Review Tray IDs.
2. Select the specific Tray ID to be deleted or touch Select All.
3. Touch Delete.
4. Touch Yes to confirm the deletion.
To delete specific Sample IDs that have not been processed:
1. Touch Review Sample IDs.
2. Select the specific Sample ID(s) to be deleted or touch Select All.
3. Touch Delete.
To delete programming from the main Sample Programming screen:
1. Enter the Tray ID or Sample ID you wish to delete.
2. Touch Delete.
AUTOMATIC SAMPLE DELETION Demonstrate how to

configure the system for
This feature is beneficial in laboratories using broadcast downloading. Permanent automatic sample deletion.
Sample IDs and samples in progress will not be deleted.
To configure automatic sample deletion, go to:
Sample Programming > Options > Review Sample IDs > Auto-
Delete
1. Touch Enable.
2. In the Auto-Delete dialog box:
a. Select the Priority, Designation, and Type of sample.
b. Select a Deletion Interval.
c. Touch OK to save the selections.
Direct participants to EXERCISE B: SAMPLE PROGRAMMING

complete the sample
programming exercise. 1. Create the following panels:
Panel Name Assays Sample/Patient Data

THYRD TSH, TT4, FT4
HEART TropI, CK-MB
ERHCG B-hCG 3 replicates x1, x5, x20
HEP HBsAg, anti-HBs, anti-HCV
2. Delete the panel “HEP” that you created in question 1.
3. Program and run the samples using Tray ID programming.
Tray ID Sample ID Panel

4 1008 THYRD
1009 HEART
1010 ERHCG
4. Delete the following sample programming:
a. Sample ID 1001
b. Programming for Tray 5
c. All programming greater than 12 hours old.
5. Use the Auto-Delete feature to configure your system to auto-delete

downloaded programming after 24 hours.
PROGRAMMING DILUTIONS Discuss how to program

dilutions.
• Two types of dilutions can be programmed from the Sample Programming
screen:
• Manual Dilution: Operator dilutes the sample at the benchtop.
• Automatic Dilution: ECi/ECiQ System performs.
To configure automatic dilutions, go to:
1. Select the appropriate fluid and assay to be configured.
2. Touch Review/Edit Analyte Data.
3. Touch Configure Dilution. Mention that the process

button will not be available if
4. Touch On or Off to enable/disable Standard Dilution. Typically, this should dilution is not supported for
remain Off. an analyte.
IMPORTANT: The assay will be diluted if Standard Dilution is enabled.
5. Touch On or Off to enable/disable Reflex Dilution.
6. Enter the number for the Standard Dilution factor or Reflex Dilution factor
and then touch OK.
NOTE: Dilution factor must be 2, 5, 10, 15, 20, 25, 50, 100, 200, or
400.
• Standard Dilution: If enabled, occurs automatically each time the

assay is requested.
• The dilution factor entered for Standard Dilution serves as the default
dilution factor that is used when an assay dilution is requested in
Sample Programming.
• Reflex Dilution: If enabled, occurs automatically if a result is outside the

Dynamic Range of the analyte.
• If the sample is still in the Sample Supply, the system uses a tip from the
Auxiliary Tip Supply to process the dilution.
• If the sample is removed from the system, the programmed dilution remains
in memory until the sample is loaded into the Sample Supply.
OVERRIDING THE DEFAULT DILUTION
You can change the default dilution during sample programming.
To override the default dilution:
1. Touch Sample Programming.
2. Select an assay.
3. Touch Assay Dil to display the default dilution.
4. Enter the required dilution factor.
5. Repeat steps 1-4 for each additional assay.
Demonstrate how to review 6. Touch Review/Edit Dilutions to review and edit dilutions or add replicate
and edit dilutions using dilutions.
Review/Edit Dilutions.
7. Touch Add to replicate the selected assay or dilution.
8. To edit a dilution, touch the dilution field, type the new dilution factor, and
then touch OK.
• To delete a dilution factor in the Review/Edit Dilutions dialog box, select the
dilution field and then touch Delete.
• Additional tips for dilutions are taken from the Auxiliary Tip Supply. Mention that you should not
add tips when the top cover
• A condition code will alert the operator if insufficient tips are present in is open.
the Auxiliary Tip Supply.
• Add tips to the Auxiliary Tip Supply: Sample Programming > Options >
Rotate Aux Tip Supply.
Dilution Codes displayed next to results:
• OD: Operator Requested Dilution
• The sample was auto-diluted using an operator entered factor.
• RD: Reflex Diluted
• ID: Invalid Dilution code Discuss the Invalid Dilution

(ID) code. Refer to the Flag
• If replicates of different factors were requested, the lowest valid and Code Summary Chart.
dilution result is posted.
CONFIGURE REFLEX PROCESSING

This function provides the ability to configure an assay to reflex repeat to the
same assay, or reflex to selected assays if outside specific ranges.
Two types of reflex processing:
• Reflex to same assay:
• Same assay is automatically ordered if the result is within specified

lower and upper ranges.
• Reflex to selected assay:
• Additional assays are automatically ordered if the result is within

Point out you are required to specified lower or upper ranges.
receive a physician request
prior to ordering additional To configure reflex processing, go to:
assays.
Options & Configuration > Enter access code > Configure
Analytes
1. Select the appropriate fluid and assay to be configured.
2. Touch Review/Edit Analyte Data.
3. Touch Configure Reflex Processing.
Demonstrate how to 4. To reflex to the same assay:

configure reflex processing to
the same assay and selected a. Touch the appropriate check box to select Lower Range and/or Upper
assays. Range.
b. Enter the appropriate range(s).
5. To reflex to selected assays:
a. Touch the appropriate check box to select Lower Range and/or Upper
Range.
b. Enter the appropriate range(s).
c. Touch Lower or Upper.
d. Select the appropriate assays for Lower or Upper.
• Additional assays ordered by reflex will not be processed if they were

ordered as part of the original sample programming.
• Components of derived tests are the exception.
• Bar coded samples still in the Sample Supply will be processed with a tip
from the Auxiliary Tip Supply.
• If no bar codes are used on the sample containers, the system will
automatically program the reflexed assay, but the operator must
assign a tray position for processing.
• RP Code: Displays next to assays that are reflex processed.
Direct participants to EXERCISE C: SAMPLE PROGRAMMING

complete the sample
programming exericise in Complete the exercise below as directed.
their participant guide.
1. Configure your ECi/ECiQ System for the following reflex processing
conditions for the TSH assay:
TSH Range Configure Reflex Processing

Lower: 0.0 - 0.02 μIU/mL Reflex to same assay
Upper: 75.0 - 100.0 μIU/mL Reflex to same assay
Lower: 0.02 - 0.47 μIU/mL Reflex to selected assay FT4
Upper: 4.68 - 100.0 μIU/mL Reflex to selected assays FT4, TT4
2. Complete the following:
a. Is your ECi/ECiQ System configured to automatically reflex dilute TSH

samples? If not, configure x2 dilution.
b. Configure the reflex dilution factor for CK-MB to be x2.
c. Program and run the following samples using Tray ID Programming:
Tray ID Sample ID Assays

6 6101 TSH x2 dilution
6202 CK-MB x25 dilution
6303 B-hCG x8 dilution
d. What dilution will the ECi/ECiQ System use to process the B-hCG for
Answer: Sample ID 6303?_______________________________
2d: 10 3. How much time remains for Sample 6101 results to be
completed?_________________________
Remind participants to use 4. Which subsystem is currently processing the B-hCG for Sample ID
View Sample Detail. 6303?_____________________
Use Table 6-1 on page 6-8

5. What is the minimum fill required when using a 16 x 75 mm Serum of the Operator’s Guide to
Separator Tube?_______________________________ answer questions 5-7.
6. You will transfer a sample to a VITROS® MicroSample Cup for processing
a TSH assay (80 μL required). Which of the following is the best volume of
sample to place in the cup?
a. 80 μL
Answers:
b. 100 μL
5. 0.5 mL plus volume.
c. 200 μL
6. c. 200 μL
d. 600 μL
7. Yes
7. You will be processing a TSH (80 μL), a T3U (10 μL), and a TT3 (20 μL)
on a sample in a 16 x 75 mm plain tube. The tube is slightly more than half 8. b
full. Will you need to use the height adapter when placing the tube in the 9. Delete request for
Universal Sample Tray?_____ Yes _____No unsupported assay
8. The following symbol has appeared under LIS on the Status
Console. Which of the following is the correct interpretation of the symbol?
a. A download message is waiting for review in Results Review > View

Sample Status > Review Download Messages.
b. A STAT has been downloaded but not yet reviewed through Sample
Programming > Options.
c. There is insufficient sample to process a reflex dilution.
d. There is insufficient sample to process the downloaded programming in Use Table 7-1 on page 7-38
the currently sampled container. of the Operator’s Guide to
9. What action should you take if the code number and message “14-Invalid answer questions 9.
assay requested” is generated from a downloaded program?
__________________________________________________________
__________________________________________________________
Exercise completed satisfactorily:__________________________________
Participant:____________________________________________________
Date:_________________________________________________________
Instructor:_____________________________________________________
Date:_________________________________________________________
MODULE 7 PERIODIC MAINTENANCE
MODULE 7
Periodic Maintenance
• Locate the Periodic Maintenance screen and review the weekly, monthly,
and as-required maintenance procedures.
• Perform the weekly, monthly, and as-required maintenance procedures

specified. Supplies Needed:
• Lint-free cloth
NOTE: You can see an example of a periodic maintenance log at the
end of this module. • Deionized water
• 70% isopropyl alcohol
• Maintenance Pack
SKILL CHECKS
• Vapor Adsorption
At the end of this topic, you will complete exercises on the concept of periodic Cartridge
maintenance.
• Reservoir Filter
NOTE: For more information on this topic, refer to the Maintenance and
Diagnostics Guide: Chapter 3, Weekly Maintenance; Chapter 4, Monthly • 3.5 inch Diskettes
Maintenance; and Chapter 5, As Required Maintenance.
• Cotton swabs

approximately 1.5 hours to
complete.
PERIODIC MAINTENANCE MODULE 7
Note where participants can LOG LOCATION

print weekly, monthly, and
as-required maintenance • Maintenance logs can be printed from:
logs.
• www.orthoclinical.com
• Maintenance and Diagnostics Guide
• Instructions for Use (IFU) CD
WEEKLY MAINTENANCE
To view the list of weekly maintenance procedures, go to:
Review weekly procedures
on the Maintenance Log with
participants. Periodic Maintenance > Weekly Maintenance
Mention the system cannot

be processing samples
NOTE: Detailed weekly, monthly, and as-required maintenance
during routine maintenance.
procedures are available through the onboard Help menu.
Clean the following items weekly:

Demonstrate weekly
maintenance protocols
• Sample Metering Proboscis:
following proper safety
procedures, using onboard
• Use a lint-free cloth dampened with distilled water or isopropyl alcohol.
Help.
• Tip Disposal Chute/Cup Retainer:
• Use warm, soapy water.
• If necessary, clean with 70% isopropyl alcohol.
• Sample Supply Subsystem:

Mention that no solvents,
abrasives, or glass cleaner • Use warm, soapy water to clean the Universal Sample Tray Holders
should be used. and Sample Supply basin.
• If necessary, clean the Bar Code Reader with a lint-free cloth

moistened with water.
• Touchscreen monitor: Point out the power lock/

unlock and the onsystem
• Turn off the monitor. display (OSD) lock on the
touchscreen monitor.
• Use ammonia-free glass cleaner or a lint-free cloth moistened with
water.
• Keyboard/Keyboard Cover
• Inspect and clean the Processing Center: Point out that you will clean
the FOB of the Luminometer
• Well Wash Prime/Purge station to troubleshoot condition
codes in the Troubleshooting
• Signal Reagent Prime/Purge station module of this guide.
• Incubator Top Cover
• Incubator Evaporation Cover Remind participants that

detailed procedures are
• Incubator Rings available though onboard
Help or the Maintenance and
• Incubator Heater Plate Diagnostics Guide.
• Incubator Shuttle Well Weight
• Inner and Outer Lift Pins
• Use a lint-free cloth moistened with distilled or deionized water.
• Then clean with a lint-free cloth moistened with 70% isopropyl alcohol.
IMPORTANT: Do NOT use bleach.
Mention that failure to

perform a successful • Perform Subsystem Cleaning:
subsystem cleaning will
result in EM codes for • Maintenance Pack(s) are stored at room temperature.
expired maintenance on all
results. • Load the Maintenance Pack. If a new lot number, you will need to scan
the Maintenance Lot Card (orange).
• Requires 30 minutes and uses 20 wells from the Maintenance Pack.

Mention that subsystem
cleaning includes cleaning • Remove the Maintenance Pack when cleaning is complete.
the Reagent Probe, Reagent
Wash Station, and Well Reagent Management > Maintenance Pack > Unload/Load
Wash Aspirate Probe.
Point out that one pack can EXERCISE: PERFORM WEEKLY MAINTENANCE
be used four times.
Using the Periodic Maintenance screen and the weekly Maintenance Log at the
end of this module as a guide, perform the required weekly maintenance on the
Ask participants to perform

weekly maintenance
following the procedures as
demonstrated in this module.
MONTHLY MAINTENANCE Demonstrate monthly

maintenance protocols
To view the list of monthly maintenance procedures, go to: following proper safety
procedures, using onboard
Help.
Periodic Maintenance > Monthly Maintenance
Perform the following procedures monthly:
• Back up quality control, calibration, and configuration files.
NOTE: See the next page in this guide for the steps to create a backup
disk.
• Inspect and clean the Reagent Cooler Filter:
• Rinse with water or vacuum.
• Air dry completely before reinstalling the filter.
• A spare filter is included in the Parts Assurance Kit.
Replace the following:
• Vapor Adsorption Cartridge (every two months):
• Shut down and power off the system.
• Filtered air is circulated over the well to remove air contaminants.
• Universal Wash Reservoir Filter (every three months):
• Depressurize the system. Mention the purpose of the

Reservoir Bottle.
• Universal Wash Reagent is filtered to improve reagent metering
precision and accuracy.
Mention to use 1.44 MB,

3.5-inch, high-density PERFORM SYSTEM BACKUP
diskettes for backup.
Create a full system backup:
• Monthly
• Following configuration changes

Point out that the system
will automatically format • After calibration
diskettes if they are not
already formatted. • Before loading system software
To create a backup, go to:
Options & Configuration > Perform Backup/Archive

Show how the write-protect
notch must be closed to
format or write information 1. Touch the check box next to the type of data you want to back up (Quality
to the disk. Open the notch Control, Calibration, or Configuration).
following backup to prevent
overwriting the data. 2. Touch Start.
3. Follow the onscreen prompts.
NOTE: Be sure to use a separate diskette for each type of data backup.
Ask participants to perform EXERCISE: PERFORM MONTHLY MAINTENANCE

monthly maintenance
following the procedures as Using the Periodic Maintenance screen and the monthly Maintenance Log at the
demonstrated in this module. end of this module as a guide, perform the monthly maintenance on the VITROS®
ECi/ECiQ System.
AS-REQUIRED MAINTENANCE Demonstrate As-Required

Maintenance protocols
To view the list of as-required maintenance procedures, go to: following proper safety
procedures.
Periodic Maintenance > As Required Maintenance
Clean the following item as required:
• System Cabinetry:
• Use a lint-free cloth moistened with warm, soapy water.
• If necessary, clean with 70% isopropyl alcohol.
IMPORTANT: Do NOT use bleach.
Ask participants to perform

EXERCISE: PERFORM AS-REQUIRED MAINTENANCE
as-required maintenance
following the procedures as
Using the Periodic Maintenance screen and the as-required Maintenance Log at
demonstrated in this module.
the end of this module as a guide, perform the as-required maintenance on the
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
Maintenance Log VITROS®ECi/ECiQ Immunodiagnostic System
Month/Year System J Number System Serial Number

Day
Daily—Check (✔) Boxes 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
Empty:
t4PMJEXBTUFDPOUBJOFS
t-JRVJEXBTUFCPUUMF
Remove outdated and empty:
Clean the signal reagent probe assembly
Inspect:
t6OJWFSTBMTBNQMFUSBZT
t.JDSPDPMMFDUJPODPOUBJOFSBEBQUFST
Verify inventory and load:
Verify that QC fluids have beenprocessed
Weekly—Date/Initial Boxes Week 1 Week 2 Week 3 Week 4 Week 5 Monthly—Date/Initial Boxes Date Initial
Clean the sample metering proboscis Back up QC, calibration, and configuration files
Clean the tip disposal chute/cup retainer Inspect the reagent cooler filter
Every two months:
Clean the sample supply subsystem Change the vapor adsorption cartridge
Every three months:
Clean the touchscreen monitor Change the universal wash reservoir filter
Clean the keyboard and keyboard cover "T3FRVJSFE%BUF*OJUJBM#PYFT Date Initial

Perform subsystem cleaning Clean the system cabinetry
Clean the processing center
*May require emptying more frequently depending on usage.
Reviewed by _____________________________________________________ Date _____________________________

Version 2.0
MODULE 8 QUALITY CONTROL
MODULE 8
Quality Control
• Specify how to store and reconstitute Quality Control fluids.
• Describe how to use the Package Insert Sheets.
• Identify when to run Quality Control. Supplies Needed:
• Configure QC software to monitor QC fluids. • Reconstituted QC

material
• Review QC data:
• Package Insert Sheets
• Review graphs and result records.
• Add comments and omit QC points. approximately two hours to
complete.
• Update baseline statistics.
• Print QC graphs and reports.
NOTE: Download the Package Insert Sheets from

www.orthoclinical.com.
SKILLS CHECKS
In this topic, you will complete exercises on defining controls and printing,
reading, and editing graphs.
Chapter 9, Performing Quality Control, and the Quick Guide: Chapter 6,
Perform Quality Control.
QUALITY CONTROL MODULE 8
VITROS IMMUNODIAGNOSTIC PRODUCTS CONTROLS

Explain how to store QC
fluids. Both Instructions for Use (IFU) and Package Inserts for VITROS®
Immunodiagnostic control fluids for MicroWell™ assays are available at:
Mention that control fluids
may be in liquid form or may www.orthoclinical.com > Technical Documents > Clinical Laboratory Products
be lyophilized. Lyophilized > VITROS® ECiQ / ECi Immunodiagnostic Systems > Instructions for Use (or
control fluids must be Package Inserts).
thoroughly reconstituted
before use. Controls fluids It is recommended that you use VITROS® Immunodiagnostic Controls to verify
should be brought to room calibration and for troubleshooting.
temperature before use.
Note that reconstitution STORE AND RECONSTITUTE QC FLUIDS

will be explained in the
calibration module. Control fluids may be in liquid form or may be lyophilized. Lyophilized control
fluids must be thoroughly reconstituted before use.
Emphasize that participants
• Store, prepare, and process all control fluids according to Package Insert
should store, prepare, and
Sheets or Instructions for Use (IFU) on www.orthoclinical.com.
process all control fluids
according to their Instructions
• Refer to the Package Insert Sheets or Instructions for Use (IFU) for open
for Use. Refer to the assay
control fluid Package vial stability.
Insert Sheets for additional
information and special
precautions. EXAMPLE PACKAGE INSERTS
Explain how to use Package

Inserts.
Explain the references in

Package Inserts for alpha-
coding.
FREQUENCY OF QUALITY CONTROL Discuss when to run QC.
• Daily
• Verification of a calibration
• After a reagent lot switch
• After maintenance, when specified
• Following a non-routine service event
• As required by local regulations
RUN QC FLUIDS
Once the QC fluid is reconstituted or for ready-to-use QC fluids:
Explain the steps to follow
• At each QC run: every time QC is run.
1. Remove the vial from the refrigerator and invert to mix. Refer to the MicroWell™
Assay Summary Chart for an
2. Transfer the amount needed into a cup. overview of the different QC
fluid materials provided by
3. Return the vial to the refrigerator. OCD.
4. Warm up the QC portion in the cup for 10 minutes and run immediately.
QC SOFTWARE FEATURES Review QC software

features and the access
code.
QC PACKAGE OVERVIEW
• Up to 18 control fluids may be defined for each assay.
• 240 files (assay/fluid combinations) can be stored.
• Each file can contain up to 1095 results.
• New results overwrite the oldest result once the file contains 1095 data
points.
Provide the access code: ACCESS CODE

68370668.
• Enter the eight-character access code for full functionality.
• When the system is sampling and processing samples, access is limited.
• See Table 9-1 “Access Levels and Availability” on page 9-8 of the
Operator’s Guide for a complete listing of the access levels.
MAIN COMPONENTS OF THE QUALITY CONTROL SCREEN
Review Data By Results organized by analyte across one or

Analyte more control fluids.
Display individual data points with Review

Results.
Omit results and add comments.
Display Levey-Jennings charts via Graph

Records.
Print a Levey-Jennings type chart in

Individual or Daily formats.
Print Records prints a list of results for the

selected analyte and control.
Review Data By Displays all analytes processed for a control

Control fluid for each QC processing event in reverse
chronological order.
Select individual results to Edit/Add

comments or Omit Records.
Print Records for a paper copy of results for

the selected record.
Review/ Define Group Intervals of control data.

Cumulative
Review Intervals data by control or analyte.
Display a Levey-Jennings chart.
Print Records for a paper copy of results.
Divide Intervals into groups greater than

three days.
Merge two or more intervals.
Remove Intervals no longer of interest.
Define Controls Define Control ID and analytes to be

monitored.
Allow 2 and 3 SD flagging by defining the

baseline mean and SD.
List All Controls to display a list of controls

already defined.
Delete Controls to remove all data for the

specified control from the system.
DEFINE CONTROL FLUIDS
Explain how to define a new DEFINE A NEW CONTROL FILE

control file.
• You may want to define a new QC file when you change the QC lot.
• Control IDs must be one to six characters. For example, a valid Control ID
is “Level1.”
• All controls must be programmed with the matching ID for the data to be
stored in the QC database. The ID is not case-sensitive.
• In addition, control fluids must be identified as Control for the sample type
when programming.
NOTE: Be careful with spaces. For example, L 1 (with the space)

is not the same as L1 (without the space).
Demonstrate how to run • In the Sample Programming screen, differentiate replicate cups of control
multiple cups using the QC by adding characters after the first six.
ID.
• For example, if you identify Cup 1 as “Level1,” you can differentiate the
Explain how to define a new replicate Cup 2 by identifying it as “Level1r.”
control.
To define a control file, go to:
Quality Control > Enter access code > Define Controls
5. Type the control ID (one to six characters).
• Optional: Enter additional descriptive information such as control

name, lot number, and expiration date.
6. Touch a body fluid.
7. Touch the assays to be monitored for this control fluid.
8. Touch Save.
DEFINE BASELINE STATISTICS

When using VITROS® Immunodiagnostic Controls, enter the expected mean and Explain how to define
SD from the Package Insert Sheet. baseline statistics.
• Define Baseline is available from both the Define Controls and the List All
Controls screens.
• If you run a control fluid before defining the baseline statistics, the results
will have the code NQ (not in QC data).
• It is optional to provide baseline statistics when controls are defined.
• You may wish to accumulate data and use record statistics as baseline
statistics at a later time.
• Controls must be assigned a baseline mean and SD before the system can
flag results.
• 1-2s ≥ 2 SD but < 3 SD from the baseline mean.
• 1-3s ≥ 3 SD from the baseline mean.
• The system will reassign the appropriate flags to data points not saved in
an interval if the baseline statistics are edited.
To define baseline statistics, go to:
Quality Control > Enter the access code > Define Controls
1. Enter the Control ID or touch List All Controls and select the control fluid
ID.
2. Touch Define Baseline.
3. Select an assay by touching the data field or press Enter to move through
the fields.
4. Type the data (Mean and SD or CV%).
5. Repeat steps 4-5 until all the data has been entered.
6. Touch OK.
Explain how to delete control DELETE CONTROL FILES

files.
• Deleting controls erases all data points for assays monitored under that
Control ID from the fixed disk.
• Controls or groups of controls may also be deleted from the List All Controls
screen by touching Delete Controls after the selection of QC ID(s).
Mention that deleted control To delete a control file, go to:

files can be restored using
the QC Backup Diskette.
Quality Control > Define Controls > List All Controls
1. Select Control ID(s).
2. Touch Delete Control.

Mention that a control file
can be deleted by entering 3. Confirm the deletion by touching Yes.
the Control ID on the Define
Control screen and touching
Delete. PROGRAM CONTROLS FOR PROCESSING
Explain how to program • If you are using barcoded control tubes and downloading programming
controls for processing. from an LIS, simply load the control tubes onto the system.
• If controls are not barcoded, assign a tray position in which the controls will
be run.
• Results will be stored in the system’s QC database only if you:
• Enter the Control ID exactly as it was defined in the Quality Control

package.
• Select Control as the sample type.
• If programming is made permanent when assigned to a tray, entering the

Tray ID will display all the programming for the tray.
• Panels may be configured for quality control fluids, if desired.
To program a control for processing, go to: Demonstrate how to

program a control for
processing.
Sample Programming > Select Tray
1. Touch the Tray button.
2. Type the Tray ID, and press Enter.
3. Type the Control ID in the Sample ID field exactly as it has been defined in
Quality Control.
4. Touch Control as the sample type.
5. Touch the body fluid button, if appropriate.
6. Touch the assays or panel to be processed for the control.
• Optional: Touch additional characteristics such as STAT, replicates,

etc.
7. Touch Save/Next.
8. Repeat steps 3-7 to program additional controls for the tray.
• Optional: Touch Perm to store the tray programming on the fixed disk
for daily use.
EXERCISE A: QUALITY CONTROL FILES

1. Set up the following quality control files:
Analyte Baseline Statistics

Fluid Information Selection Mean SD Units
Control ID: Level1
Name: Free Thyroid 1 TSH 0.07 0.01 μIU/mL
Lot Number: 0270 FT4 0.59 0.05 ng/dL
Control ID: Level2

Name: Free Thyroid 1 TSH 1.40 0.14 μIUmL
Control ID: Level3

Name: Free Thyroid 1 TSH 22.9 2.01 μIUmL
Return to the classroom for 2. Program the three levels of controls as defined above.
further QC discussion as the
controls are processing. 3. What two actions ensure the programming will be recognized as control
fluids and results stored in the database?
Answers: a. ________________________________________
3.a. Use the Control ID as b. ________________________________________

the Sample ID.
3.b. Touch Control as

sample type.
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
REVIEW QC DATA AND GRAPHS
REVIEW RESULTS BY ANALYTE Demonstrate how to review

results by analyte.
• Results are organized by analyte across one or more control fluids.
To review results by analyte, go to:
Quality Control > Enter access code > Review Data by Analyte
NOTE: Results may be viewed but not edited or omitted without the
access code.
1. Touch a body fluid and analyte.
2. Touch the control ID button(s) you want to review.
a. Optional: Set Filter to limit the data displayed.
3. Touch Review Results.
4. Touch the checkbox in front of the control(s) you wish to review to activate
the Process buttons.
OMIT DATA
Demonstrate how to omit
• Omit or undo the omission of all or individual results in selected control data.
result records.
• Omitted results are not included in statistical computations.
• Omitted results are not deleted and may be included again if desired.
• Omit Records on the Review Result by Analyte screen will omit all data
points for the selected control fluid.
• Use Omit Records from the Expand Analyte Record or Review Results by
Control screens to omit individual results.
• An “O” next to the control result record indicates that the data point has
been omitted.
Mention that Omit Records To omit data, go to:

toggles to Include Records
where you can re-include
Quality Control > Enter the access code > Review Data by
data.
Analyte
2. Touch the Control ID button(s) you want to review.
• Optional: Set Filter to limit the data displayed.
4. Touch the check box in front of the control you wish to review to activate the
Process buttons.
• Optional: Touch Omit Records to omit all results in the selected

control file.
5. Touch Expand Record.
6. Touch the check box in front of the result(s) you wish to omit.
7. Touch Omit Records.
ADD COMMENTS Demonstrate how to add a

comment.
• Data points may be marked with comments chosen from four categories:
• Performance pertains to the performance of the system. Review the list of comment
choices.
• Integrity pertains to the integrity of the system consumables.
• Rules pertains to the procedural rules determining the state of a Mention that there is no free
control on the system. text.
• Miscellaneous displays additional comments not relevant to the other

comment categories.
• Up to two comments can be added per data point.
• Choose an application for adding or removing comments.
• “Add - where space permits” prevents overwriting existing comments.
• “Add - overwrite if necessary” gives new comments priority over

existing comments.
• “Remove” disassociates comment(s).
• Touch Edit/Add Comments on the Review Results by Analyte screen to

place the selected comments on all data points for the selected control(s).
NOTE: Omit Results and Edit/Add Comments from the Review

Results by Control screen allow you to edit all analytes at once for a
given control over a given period of time. This is useful if control fluids
were inadvertantly switched.
To add a comment, go to:
Analyte
4. Touch the check box in front of the control you wish to review to activate the
Process buttons.
6. Touch the check box in front of the result(s) for which you wish to add a
comment.
7. Touch Edit/Add Comments.
8. Touch the Category Application for up to two comments.
9. Touch OK to save your choices.
DISPLAY AND PRINT GRAPHS Display a graph on the

screen and demonstrate
how to use graphs.
DISPLAY GRAPHS
• The date range may be edited to display a portion of the graphed data
points.
• Text entered into the Comment line will appear in the header of the printed
graph but will not be saved in the system’s memory.
• The graph’s mean and SD may be viewed as either by Baseline or by

Record (actual performance) by touching the appropriate button under
Graph Statistics.
• Touch Show Omitted to view omitted points on the graph.
• Use the arrow buttons to scroll and highlight individual data points.
• Touch Omit Point to remove the data point from statistical

calculations.
• Touch Include Point to include the point again, if it had been omitted.
• Note that comments cannot be added on this screen.
• Graphs may also be printed directly from the Review Data by Analyte
screen without first reviewing the graph.
• SDI (Standard Deviation Index) = (Result - Mean) / SD.
PRINT QC GRAPHS AND REPORTS
Demonstrate how to print QC Results may be printed organized by analyte or control fluid in the following
QC graphs and reports. formats:
• As an Individual graph
• As a Daily graph
• As a list of results
• Two types of graphs may be printed by touching Print Graphs from the
Hand out an example of Review Results by Analyte screen.
each type of graph.
• Individual graphs show one data point per line.
• Comment numbers are displayed in the right-hand margin under Com

for each data point.
• The graph legend provides the comment text for any comment
numbers shown on the graph.
• Daily graphs show one day per line.
• The mean with range bars of all quality control results processed in a
given day is shown.
• No comments are displayed.
To display and print graph records, go to:
Analyte.
1. Touch a body fluid and an analyte.
3. Touch Review Results. Mention that the Levey-

Jennings chart is in a vertical
4. Touch the check box in front of the control you wish to review to activate the format.
Process buttons.
• Optional: Touch Set Filter to enter a date range of data to be

displayed.
5. Touch Print Graph.
6. Select Individual or Daily.
DISPLAY AND PRINT THE QUALITY CONTROL REPORT
A list of results may be printed by analyte or control.
• These reports list omitted datapoints and associated comment codes.
• The legend displays text for comment codes.
• Touch Print Records from the Review Data by Analyte screen to generate
this report.
• This report can also be printed from the Expand Analyte Record screen by
touching Print Results.
UPDATE BASELINE MEANS
Explain when and how to When?

update baseline means.
• Update the baseline statistics when entering a preliminary or baseline
mean for a new lot of reagents or a new lot of QC fluid (and the same QC
target is kept).
How?
Demonstrate how to edit Baseline statistics can be updated in two ways:

baseline statistics.
• Editing manually using Define Control.
• Edit Baseline using collected data.
To edit baseline statistics manually using Define Control, go to:
Define Control
1. Type in the Control ID.
2. Select the analyte(s).
3. Touch Define Baseline.
4. Update the baseline as needed.
5. Touch OK.
To edit baseline statistics using collected data, go to:
Analyte
1. Touch a body fluid and an analyte.
2. Touch the Control ID button(s).
4. Touch the check box in front of the control you wish to edit.
6. Touch Edit Baseline.
NOTE: The Record Statistics Mean is calculated using all the non-
omitted points in the defined date range.
7. Type the new Baseline Statistics or touch Update to use the Record
Statistics.
Mention that both the mean

NOTE: Both the baseline mean and SD are updated if Update is and SD are updated and
selected. that participants may want to
change the SD back to what
8. Touch OK to save your choices. it was.
REVIEW RESULTS BY CONTROL
• Results are organized by processing event in reverse chronological order. Explain how to review
results by control.
• Omit Results and Edit/Add Comments from the Review Results by
Control screen allows you to edit all analytes at once for a given control
over a given time period.
• This is useful if control fluids were inadvertantly switched.
To review results by control, go to: Demonstrate how to review

results by control.
Control
1. Touch the control ID button you want to review or type a Control ID in the
Locate field.
3. Touch Previous Record to display the next most recent record.
4. Touch the check box in front of the analyte(s) you wish to review to activate
• Optional: Touch Select All to select all analytes.
EXERCISE B: GRAPHS
1. Print an Individual Graph and Daily Graph for:
Analyte: TSH
Control ID: 111111
Date Range: 1/1/1997 to 1/15/1997
2. Use the Individual and Daily Graphs printed in Question 1 to answer the
following questions.
a. What are the Baseline Mean and SD?_________________________
b. What mean and SD represent the actual performance of the system

during the specified time period?_____________________________
c. Are any data points omitted from the statistical

calculations?____________________________________________
d. Are there any comments?__________________________________
e. What do the comments mean?______________________________
f. How many 1-2s flags are printed?____________________________
g. How many 1-3s flags are printed?____________________________
3. Practice omitting data points and adding comments.
a. Omit all 1-3s flagged results for Control ID 111111 for TSH in January
1997.
b. Add comment numbers 4 (Inappropriate QC Fluid Used) and 49

(Supervisor reviewed and accepted) for each omitted data point.
4. Reprint an Individual graph for:
Analyte: TSH
Control ID: 111111
Date Range: 1/1/1997 to 1/15/1997
5. Use the Individual Graph printed in Question 4 to answer the following

questions.
a. What are the newly-calculated Record Mean and SD?____________
b. How many datapoints are omitted according to the graph’s

header?___________________
c. What type of report will display the omitted datapoints in a list

format?___________________
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
CUMULATIVE STATISTICS
DEFINE INTERVALS
Explain how to review and The Review/Define Cumulative feature allows you to:
define cumulative statistics.
• Group control data into user-defined time periods in order to:
• Separate data from different lots of control fluid.
• Review data from past individual intervals as well as the cumulative

sum of those intervals.
• Up to 18 intervals can be defined for assay/fluid combinations.
• Once an interval has been defined, follow the same path shown to edit the
baseline statistics for the interval.
NOTE: Editing Baseline Statistics in Review Data by Analyte will not

change the baseline data of existing intervals.
Demonstrate how to define To define an interval, go to:

an interval.
Quality Control > Enter access code > Review/Define
Cumulative
1. Touch a body fluid and assay.
2. Touch the Control ID button.
3. Touch Review Intervals.
4. Touch Define/Edit Interval.
5. Enter an interval name and date range.
6. Touch OK to save the interval.
REVIEW INTERVALS
• Intervals may be reviewed by analyte or control.
• You can do the following with intervals:
• Divide Interval to break intervals into smaller data groupings.
• Merge Intervals to combine two or more data groupings.
• Remove Intervals to delete the data grouping.
• Use Graph Records to display a Levey-Jennings chart of data within the

interval.
MODULE 9 RESULTS REVIEW
MODULE 9
Results Review
• Identify the main components of the Results Review screen.
• Define search results criteria to display results in desired format. Supplies Needed:
• Locate and interpret results. • 3.5-in. diskettes
• Delete result records.
• Release deferred reports.
• Edit results and patient data.
• Recalculate results after a failed calibration to avoid reprocessing.
• Send results to a printer or Laboratory Information System (LIS) on demand

and cancel print requests. State that this module takes
approximately one hour to
• Use Result Intellicheck® to view Intellicheck® verifications for samples and
complete.
assays.
• Archive patient results to DOS-formatted diskette.
• Retrieve and review archived results.
SKILLS CHECK
In this topic, you will complete a review results exercise.

Guide: Chapter 8, Reviewing Results and Chapter 11, Configuring and
Customizing Your System.
RESULTS REVIEW MODULE 9
Review the main MAIN COMPONENTS OF THE RESULTS REVIEW SCREEN

components of the Review View Sample Time until all samples in progress are completed.
Results screen. Status
Listed by Sample ID or tray.
Mention that the last 60 View Sample Detail lists time to result and
results will be listed. current processing location for all assays for a given
sample.
Monitor View all patient, control, and calibrator results as
Results they are completed.
Results are available for review prior to printing or

uploading to an LIS.
Search/ Set search criteria to find the desired result record(s)
Review/Edit from the 5000 in memory.
Review, edit, or delete results.
Send results to the printer or LIS.
Release deferred results.
Cancel reports.
Retrieve/ Retrieve results from archive diskettes to review,
Review print, or copy to a DOS-formatted diskette.
Archive
Review Summary of reports pending print, upload to the LIS,
Report Status or are deferred.
Pending number of archived records.
DISPLAY RECORDS Review Display Records.
• 5000 result records in memory.
• Search criteria:
• All fields are optional.
• Enter as much patient demographic information as desired.
• Select sample type and priority if desired.
• Time, if specified, must be entered in a four-digit year format.
• Last 24 Hours narrows the search to samples run within the last 24
hours.
• All Dates opens the search to all results stored in memory. The Start
and End dates/times displayed are the processing times of the oldest
and newest records, respectively, in memory.
To display results, go to:
Results Review > Search/Review/Edit
Mention that a Sample ID is

typically unique.
1. Enter known information about the record(s) for which you are searching.
• Optional: Touch Set Report Search Criteria to use report status as

search criteria.
2. Touch Search.
3. The Status Line indicates the number of matches. Redefine search criteria
as necessary.
4. Touch Review/Edit to display the record(s) matching the search criteria.
5. Touch the check box in front of the record(s) you wish to review to activate
MAIN FEATURES OF THE REVIEW/EDIT RESULTS SCREEN

• Sample ID
• Unnamed means there is no Sample ID.
• S in red to the left of the check box means STAT.
• Type
• Con is Control.
• Blank is a patient sample.
• Fluid
• Body fluid for the sample.
• Blank means serum.
• Lot
• Reagent lot number for the assay.
• C/F
• Codes and flags.
• Flags have priority over codes.
• Up to two flags or codes per result.
• Dil
• On-board diluent factor.
• Reflex dilutions are preceded by an *.
PROCESS BUTTONS
Set Report Override the report defaults set in Options &

Status Configuration.
Reprint or resend reports.

Release Send reports to a printer or upload results to an
Deferred LIS.
Edit Pat Data Edit or display patient demographics.
Change report requests via Set Report Status.
Edit/Add Edit results that were programmed for the

Analytes sample.
Add results or derived tests not programmed

prior to processing the sample via Add Online
Analytes.
Recalculate Recalculates all results, including control results,
Results following a failed calibration. Mention that to recalculate
a result, the feature must be
Recalculation must be based on a valid enabled in Sample/Result
calibration of the same reagent lot and protocol Options under Options &
as the failed calibration. Configuration.
Delete Records Delete result record(s) from the fixed disk.
Select All Places a check mark in front of all records.
Review how to send/cancel SEND/CANCEL RESULTS TO A PRINTER OR LIS

results to a printer or LIS.
• The ECi/ECiQ System is configured to automatically send reports to the
printer and/or Laboratory Information System (LIS).
• Use Set Report Status to:
• Print additional copies of these reports.
• Print report types not requested routinely.
• Upload results to an LIS on demand.
• Set Report Status dialog box:
• No Action: No change to the record’s report status.
• Off/Cancel: Stops a pending report from printing or uploading.
• Send: Generates a report.
• Defer: Prevents the report from printing or uploading until the operator
releases it. It is more likely that you would defer reports prior to
processing.
• Archive: Enables or disables archive request or removes archive

status of selected records.
• Set Report Status is found on multiple screens and has the same
functions on each:
• Search/Review/Edit
• Review/Edit Results
• Edit Patient Data
To send results to a printer or LIS, go to:

search criteria.
2. Touch Set Report Status to display the Set Report Status dialog box.
3. Select the desired buttons for each Report Type.
4. Touch OK.
5. Touch Return.
To cancel results to a printer or LIS, go to:

search criteria.
2. Touch Set Report Status to display the Set Report Status dialog box.
3. Select OFF/Cancel for each report type.
4. Touch OK.
5. Touch Return.
Review how to release RELEASE DEFERRED RESULTS

deferred results.
• Review Report Status on the main Results Review screen.
• Displays a summary of reports waiting to print, upload to the LIS, or be

released if deferred.
• Release Deferred is found on two screens:
• Search/Review/Edit
• Review/Edit Results
• Release Deferred Reports dialog box lets you select the type of deferred
report to release.
• Yes: Release the report.
• No: Do not release the report yet.
To release deferred results, go to:
Results Review > Search/Review/Edit.

search criteria.
• Optional: Touch Review/Edit to display the record(s) before releasing.
2. Touch Release Deferred.
3. Touch Yes to release the specified report type.
4. Touch OK.
5. Touch Return on the Search/Review/Edit screen.
Review how to edit results.

EDIT RESULTS
EDIT RECORDS WHEN:
• Demographics need to be entered or edited after a sample is processed.
• Used to combine multiple reports on a given sample.
• A new record is generated each time a sample is rerun, even if the

same Sample ID is used.
• You wish to add results processed on another system to the report.
GENERAL NOTES ABOUT EDITING
• Up to 50 results can be included per record.
• A revised laboratory report is automatically printed if the system

configuration allows.
• Derived tests cannot be edited. Recalculation occurs when components are

edited.
• Mean results cannot be edited. Edit replicate results instead.
• ED code displays next to edited results.
• Other codes are assigned as appropriate.
ADD ONLINE ANALYTES
• Add analyte results or derived test results that were not part of the original
programming.
• Derived tests cannot be edited.
• Only components of derived tests can be edited.
• The system recalculates derived tests when components are edited.
To edit results, go to:
1. Enter known information about the record for which you are searching.

search criteria.
2. Touch Review/Edit.
3. Select record to edit.
4. Touch Edit/Add Analytes.
5. Touch the Analyte Result field to enter the result.
6. Touch Return /Save.
To add on-line analytes, go to:
Results Review > Search Review/Edit.

search criteria.
2. Touch Review Edit.
3. Select a record to edit.
4. Touch Edit/Add Analytes > Add On-Line Analytes.
5. Touch the analyte button(s) to be added to the result record.
6. Touch OK.
7. Enter results for the added analyte(s).
8. Touch Return/Save.
NOTE: ED code posts in the C/F column and a new lab report will print.
Review how to edit EDIT DEMOGRAPHICS

demographics.
• Demographics may be entered before processing samples in Sample
Programming, or they may be entered after the sample has been
processed.
• Report(s) may be resent to the printer or LIS via Set Report Status.
• Report(s) may be cancelled by touching Off via Set Report Status.
• EP Code appears when demographics have been edited. A revised patient

report is automatically printed if the system configuration allows.
To edit demographics, go to:

search criteria.
3. Select a record to edit.
4. Touch Edit Pat Data.
5. Press Enter to move through the fields in which you will add or edit.
• Optional: Touch Set Report Status to request a report to print.
RESULT INTELLICHECK® Review how to use Result

Intellicheck®.
• Use Result Intellicheck® to view Intellicheck® verifications performed for
each sample and assay processed.
• You can also navigate to Result Intellicheck® from View Sample Status and
Monitor Results.
• Intellicheck® verifications include:
• Sample Metering: Displays Sample Metering verifications for clots,

bubbles, and other detections.
• Reagent Metering: Displays Reagent Metering verifications to verify

overall subsystem performance.
• Well Wash: Displays verification data and exceptions to verify volumes

of Universal Wash Reagent.
• Signal Reagent: Displays verification data and exceptions for

dispense volume of Signal Reagent.
• Sample and Reagent: Displays verification data and exceptions to

verify dispense of sample and assay reagent volumes in the well (after
incubation).
• Luminometer: Displays verification data for self-calibration of the

luminometer performed for each well processed.
To use Result Intellicheck®, go to:
2. Select a record to review.
3. Touch Result Intellicheck.
• Optional: Select Next Result to review additional analytes run on the

sample. Select Previous Result to go back to the previous analyte.
4. Touch Print for a paper copy.
ARCHIVING/RETRIEVING ARCHIVED RESULTS
OVERVIEW
Review how to archive/ The Archive/Retrieve feature allows results to be archived to system diskettes that
retrieve archived results. can later be used to:
• Retrieve archived results from the diskette to be reviewed or printed.
• Copy from the system diskette to be saved onto a DOS-formatted

diskette to use with other data applications.
The archiving process includes three steps:
• Selecting records for archiving.
• Archiving result records.
• Retrieving records from a system diskette for review, printing, or

copying to a diskette.
SELECTING RECORDS FOR ARCHIVING
There are two methods to select records for archiving to a system diskette:
• Enable Result Record Retention in Options & Configuration.
• Set Report Status to enable archiving of selected records in Results

Review.
Demonstrate how to enable To enable result record retention, go to:

result record retention.
Options & Configuration > Enter the access code > Configure
System > Sample/Result Options
1. Set Result Record Retention to Enable.
To set report status to enable archiving of selected records, go to: Demonstrate how to set
report status to enable
archiving of selected records.
2. Enter search criteria.
3. Touch Set Report Status.
4. Touch Enable to archive.
ARCHIVING RESULT RECORDS TO A SYSTEM DISKETTE
• Use a 1.44 megabyte 3.5-inch, high-density DOS-formatted diskette.

Mention that approximately
• Ensure the diskette is write-enabled. 1100 records can be stored
on a diskette.
• Ensure the diskette is oriented properly before placing it in the drive.
• The arrow on the diskette should point toward the drive.

Mention that a new diskette
• Monitor the archive process in case additional diskettes are required. should be used each time
archiving is performed.
• Label the diskette with the following information:
• Sequence Number
• Total Number of Records
• System ID
• Software Version Number
• Current Date and Time
• Date Range and Time

Guide: Chapter 11, Configuring and Customizing Your System, System
Services, Archiving Result Records.
To archive result records, go to:
Options & Configurations > Enter access code > Perform

Backup/Archive > Archive Results
1. Select All results set for archive or Adjustable date range.
a. If you selected Adjustable date range, enter the appropriate date

range.
2. Touch OK.
NOTE: The number of records to be archived will be displayed.
3. Touch OK.
4. Follow the screen prompts to load a diskette and archive result records.
5. Touch OK.
6. Touch Return when the process is complete.
7. Label the diskette.
RETRIEVE AND REVIEW ARCHIVED RESULTS
• Archived result records can be retrieved for viewing, printing, or copying to

a DOS-formatted diskette.
• Retrieving and reviewing archived results is a two-step process:
• Retrieving archived result records from diskette.
• Entering search criteria to display the desired records.
• Touch Search to display the number of result records matching your search
criteria on the status line. If the number is too high or too low, change your
search criteria before continuing.
• Touch Help for information related to the displayed screen.
To retrieve and review archived results, go to:
Results Review > Retrieve/Review Archive
1. Touch Retrieve Archive.
2. Insert the diskette containing the archived result records you wish to
retrieve.
3. Touch OK.
4. Follow the screen prompt to restore the archived data.
5. Touch Yes to use this data to restore or No to cancel.
NOTE: The prompt line will indicate if the process was successful.
6. Type in or select search criteria to define record(s) you wish to retrieve.
7. Touch Search.
NOTE: The number of records that match will be displayed.
8. Touch Review Archive.
9. Select the records you wish to print or copy to a DOS-formatted diskette

or touch Select All to select all records for printing or copying to a DOS-
formatted diskette.
10. Touch Print to print the selected records or insert a blank DOS-formatted
diskette into the disk drive and touch Copy to DOS Diskette to copy in
DOS format.
NOTE: You can print either a laboratory report or a patient report or

both.
11. Follow screen prompts to complete the copying of selected records.
EXERCISE A: RESULTS REVIEW

For questions 1 - 9, enter the adjustable range as 02/01/2008 to 02/28/2008.
1. Review results for all STAT samples processed on the system.
2. Display all samples processed on 2/7/2008.
3. Print a patient report for patient Richard Chauncey.
4. Print a laboratory report for the results of Sample ID 3002.
5. What lot number of TSH was used to process Sample ID 3002?

___________
6. Sample ID SU2221 was rerun because of incomplete results. Edit the initial
record for Sample ID SU2221 to include the 1.16 μIU/mL TSH result from
its rerun.
7. Add a FT4 result of 1.58 ng/mL to the result record for Sample ID SU2221.
Answer: 8. Add a TT3: 1.46 ng/mL, TT4: 8.6 μg/dL and a TT3/TT4 Ratio to the re-
sult record for Sample ID 3004. What is the calculated TT3/TT4 result?
8. 0.17 _________________
9. Using Edit Pat Data, add the patient name Marc Catera to the result
record for Sample ID 3004.
For questions 10 -11, search on the last 24 hours.
10. Review the Result Intellicheck® verifications for Sample ID SU1111 and
record any exceptions noted: ____________________.
11. Generate the Result Intellicheck® report for Sample ID SU1113. Circle the
Sample and Reagent verification data on this report.
For questions 12 -14, search on February 2008.
12. Use Results Review to select the records from 2/1/2008 to 2/28/2008 to
be archived.
13. Using the diskette provided, archive the records for February 2008 to a
diskette using Options & Configuration.
14. Retrieve Sample ID 3003, and print a patient report.
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
MODULE 10 CALIBRATION
MODULE 10
Calibration
MODULE OBJECTIVES Review objectives for this
module in the participant
• Specify when to calibrate the system.
• Identify how to store and handle calibrators. Supplies Needed:
• Process calibrators with or without bar code labels. • Calibrator Kits
• Locate and review calibration detail. • QC fluids
• Review and modify lot-specific calibration data. • Bar code labels or bar
coded tubes
• Restore calibrations.
• Assign primary status to calibrations.
• Delete calibrations. State that this module takes

approximately two hours to
• Differentiate between successful and unsuccessful calibration reports. complete.
• Identify how to enter a user calibration.
• Recalculate results.
SKILL CHECKS
In this module, you will complete an exercise on the concept of calibration.
Chapter 5, Performing Calibration, and the Quick Guide: Chapter 3,
Perform Calibration.
CALIBRATION MODULE 10
CALIBRATION OVERVIEW
WHAT IS CALIBRATION?
• A master calibration based on 1 to 10 master calibrators is established by

the manufacturer.
• Master calibration data is transferred to the system via the Reagent Lot
Calibration Card.
• Customer Calibration adjusts the master curve to compensate for any

assay protocol, reagent lot, or systematic changes in the system.
Explain when it is necessary WHEN TO CALIBRATE

to calibrate.
You must calibrate:
• Every 28 days for most assays (refer to Instructions for Use [IFU] for each
assay).
• When reagent lot number changes.
• When an assay’s protocol changes.
• As recommended by regulations.
You may need to calibrate:
• Following non-routine system service.
• When QC is out of range (calibration is the last troubleshooting step).
CALIBRATORS Discuss the contents of the

calibrator kit.
The calibrator kit contains:
• One to three calibrators in one of two formats:
• Liquid, ready to use
• Lyophilized - reconstitute with 1.0 mL distilled water Explain that the liquid
calibrator kits contain one set
• Protocol Card (blue) with assay processing information including: and 2 mL per level.
• Incubation time
• Sample and reagent volumes
• Wash protocols
Explain that the lyophilized
• Reagent Lot Calibration Card (green) with lot-specific information including: calibrator kits contain three
sets and 1 mL per level.
• Master calibration information
• Calibrator concentrations
• Dynamic Range
• Expiration date of the reagent lot
• Calibrator Bar Codes
• Liquid calibrators are provided in bar coded tubes. Additional bar code
labels are included.
• Lyophilized calibrators are packaged with bar code labels to be affixed

to tubes used during calibration processing.
IMPORTANT: The calibrator lot number must match the reagent lot
number.
Demonstrate how to PROCESSING CALIBRATORS

process bar-coded
calibrators. • Liquid calibrators are packaged in bar-coded tubes and may be placed
directly on the system. Use the sample tray’s built-in height adapter.
• Lyophilized calibrators can be transferred into cups, placed on top of tubes,

with calibrator bar code labels affixed on the tubes.
• Calibration is random access:
• Calibrators may be placed in any tray position in any sequence.
• QC and patient samples can be processed with calibrators, but this is

not recommended.
Discuss the process if one • Do NOT process QC before the calibrators.

or two levels fail to run.
IMPORTANT: All levels of calibrators in a set must be processed within
two hours. Verify that enough tips have been loaded on the tray to
process the calibrators.
• Upon completion of the last calibrator in a set, the calibration becomes the
current calibration.
• Remove the calibrators after they are processed to prevent the system from
trying to reprocess them.
NOTE: The system will not utilize the Auxiliary Tip Supply to process
calibrators.
To process calibrators:
1. Verify that the Protocol and/or Reagent Lot Calibration Cards are scanned.
2. Verify that the reagent pack for the assay lot to be calibrated is loaded.
3. If necessary, reconstitute the calibrators. All calibrators must be room

temperature. Remind participants that
barcoded calibrators may be
4. Verify PSID is enabled. loaded on the system in any
position or sequence.
5. Load the tray into the Sample Supply.
• Bar coded calibrator tubes may be loaded on the system in any

position or sequence.
6. Touch Sample Processing to begin processing.
PROCESSING CALIBRATORS WITHOUT BAR CODES Demonstrate how to

process calibrators without
All calibrators are packaged with bar code labels. If bar code labels are damaged bar codes.
or lost, calibrations may be manually programmed in Sample Programming.
To process calibrators without bar codes:

Review information
1. Touch Sample Programming. contained in Calibrator ID:
• Optional: Touch STAT to assign the calibration immediate priority. • The first four digits
identify the Cal Lot No.
2. Touch Tray. Enter the tray ID and press Enter on the keyboard.
• Options >
3. Enter the Calibrator ID in the Sample ID field. Review Cal
Definition
NOTE: The body fluid and assay will be determined automatically by • The middle digit
the system from the calibrator ID. identifies the level.
• The last three digits

identify the Protocol
4. Touch Cal.
ID.
5. Touch Save/Next.
• GEM-C listed on
Calibrator Kit box.
6. Repeat steps 3-5 to program each additional calibrator level for the tray.
• The first three
7. Touch Sample Processing to begin processing.
digits of Protocol
Card ID.
Explain the different EVALUATING CALIBRATION STATUS

calibration status indicators.
The Review Calibration screen may be used together with the Review Cal Detail
screen to check the status of a calibration in progress.
Calibration Status
• In Progress: A calibration has been initiated.
• At least one calibrator has been metered.
• Current/Failed: The Current or In Progress calibration failed.

Explain how to proceed if
• Failed: Calibration was unsuccessful due to mechanical, quality check, or
calibration is in progress,
time limit failure.
but one or two levels are
missing.
• Calibration will fail if a calibrator is rerun before the other required
levels are processed, or two hours elapse before all levels are run.
To review the status of a calibration in progress, go to:
Options & Configuration > Enter access code > Review/User

Calibrations > Review Calibrations
Review Cal Detail
Select a calibration and touch Review Cal Detail to investigate the

cause of a failed calibration or the status of a calibration in progress.
EXERCISE A: CALIBRATION Direct participants to

complete the calibration
1. Scan the Reagent Lot Card(s) provided by your instructor, if necessary. exercise in their participant
guide and then return to the
2. Calibrate the assays assigned by your instructor. If you are working as classroom.
partners, each individual is required to perform the calibration.
Operator 1 Operator 2
Calibrate HBsAg B-hCG, FSH
NOTE: Post-calibration QC will be run when the calibrations are

complete.
Exercise completed satisfactorily:____________________________________
Participant:______________________________________________________
Date:___________________________________________________________
Instructor:_______________________________________________________
Date___________________________________________________________
REVIEW AND MODIFY LOT SPECIFIC CALIBRATION DATA
REVIEW CAL DEFINITION
The data on this screen is uploaded from the Reagent Lot Calibration Card. Lot-
Review the information on specific information is stored for up to 16 reagent lots.
the Review Cal Definition
screen.
NOTE: If the new lot is not displayed, the reagent lot card was not
scanned successfully.
The letter M will display at the left of user-modified data fields:
• The M1 code prints on laboratory and calibration reports next to results

generated from a calibration with a user-modified Dynamic Range.
• The M2 code prints on laboratory and calibration reports next to results

Refer to Table 5-1, generated from a calibration with user-modified calibrator concentrations.
“Parameters Overwritten for
Current Lot” on page 5-15 of • Rescanning the Reagent Lot Calibration Card may overwrite modifications
the Operator’s Guide. made to this screen.
To review and modify calibration data, go to:

Calibrations
1. Select the appropriate body fluid and assay.
2. Touch Review Cal Definition.
• Optional: Touch No to disable the assay’s calibrations.
3. Select a reagent lot number to view or modify data.
• Optional: Select the data entry field you wish to modify.
REVIEW CALIBRATIONS
Calibrations are listed in chronological order with the most recent first within a lot
number. For each body fluid, 25 calibrations may be stored in memory.
CALIBRATION TYPES Discuss the calibration

types.
• Blank: (no type) No user input.
• User Cal: Parameters were entered manually.
• User Mod: Calibrator concentration or the Dynamic Range were modified

manually on the Review Cal Definition screen.
• User Mod/Cal: Combination of User Cal and User Mod.
CALIBRATION STATUS INDICATORS Discuss each of the

calibration status indicators.
• Current: Calibration is in use and will be used for result predictions.
• Primary: Calibration used when an automatic lot switch occurs.
• Expired: The calibration has exceeded the calibration interval (typically 28

days).
• In Progress: The calibration results are being calculated.
• N/A (not available): Protocol is not supported.
• Current/Expired: The current calibration is expired.
• Current/Failed: The current calibration failed.
To review calibrations, go to:

Calibrations
2. Touch Review Calibrations.
3. Select the appropriate calibration to activate the process buttons.
Demonstrate how to restore, RESTORE, MAKE PRIMARY, AND DELETE CALIBRATIONS

make primary, and delete a
calibration. Following a calibration event, the calibration becomes the current calibration.
• A failed calibration will also become the current calibration.
• Touch Restore Cal to place another calibration in use.
• If multiple calibrations exist for a reagent lot, the most recent calibration will
be used for an automatic lot switch.
• Calibrations may be designated as the one to use in the event of a lot

switch with Make Primary.
• Calibrations that are In Progress or NA (not available) cannot be restored

or changed to Primary.
• Calibrations that are In Progress cannot be deleted.
To Restore, Make Primary or Delete calibrations, go to:

Calibrations
2. Touch Review Calibrations.
3. Select the appropriate calibration to activate the process buttons.
4. Touch Restore Cal to make the calibration current.
5. Touch Make Primary to mark a calibration for use when a lot switch occurs.
6. Touch Delete Calibration to delete the calibration from the system’s

memory.
REVIEW CALIBRATOR DATA AND PREDICTION CURVE Mention that all qualitative
assays process two wells per
• Calibrators are processed as a single replicate for quantitative assays calibrator level.
unless the operator programs replicates in Sample Programming or
changes the default in Options & Configuration > Configure Analytes.
• If replicates are processed, only the mean will appear on the

Calibration Report.
• The View Replicates dialog box shows status or codes specific to

each replicate. Mention that View Cal
Parameters will be
To view codes specific to each replicate, go to: discussed later in this
module.
Options & Configuration > Enter access code > Review
Calibrations > Review Cal Detail > View Replicates
CALIBRATOR DATA
To view calibrator data, go to:
Options & Configuration > Enter access code > Review

Calibrations > Review Cal Detail
• Concentration: From the Reagent Lot Calibration Card unless processed

calibrator’s concentration have been modified in the Review Cal Definition
screen.
• M1: Level 1 master curve calibrator.
• C1: Level 1 instrument processed calibrator.
• Light units:
• As measured by the system for C1, C2, or C3.
• From the Master Curve for M1, M2, M3, up to M10.
CALIBRATION PROCESS
A master calibration based on one to ten master calibrators is established for
each reagent lot by the manufacturer. Master calibration data is uploaded to the
system through the Reagent Lot Calibration Card.
• The calibrators you process on the system have been assigned

concentrations from the master curve (C1, C2, or C3).
• Light units generated by the processed calibrators are compared with

expected values based on the master curve. The percentage difference
between expected and actual is calculated and the master curve is
rescaled accordingly.
• The system checks the instrument-generated calibration curve against

quality parameter acceptance limits. If the curve meets these acceptance
limits, the calibration is acceptable.
• The most recent calibration becomes current.
• Verify the calibration by processing Quality Control fluids.
Example of a Quantitative Calibration
Light Units 2
(from system’s
calibration)
M1 M2 M3 M4 M5 M6 M7 M8
C1 C2 C3
3
4
Concentration
(from Reagent Lot Card)
1 Instrument-Generated Calibration Curve

2 Manufacturer-Generated Calibration Curve (Master Curve)
3 Calibrator Concentration (C1, C2, C3)
4 Master Calibrator Concentration (M1, M2, ...)
Mention that you can also QUALITY PARAMETERS

view quality parameters on
the Calibration Report. To display quality parameters, touch View Cal Parameters on the Review Cal
Detail screen.
Three quality parameters are used to check the integrity of the instrument
generated calibration curve:
• Spread Percent: Replicate precision check that is used only when

Explain that spread percent
replicates are processed for calibrators. (0.0 is optimal.)
is typically used for Hepatitis
assays only. • Calibrator Signal Index (CSI): Checks the difference between the
instrument-generated signal for the processed calibrators and the expected
signal based on the master curve. (0.0 is optimal.)
• Delta Ratio: Checks the acceptability of the curve shape by comparing the
ratios of the processed calibrator signals to those expected based on the
Explain “+” or “-” indicates master curve. (0.0 is optimal.)
the position of the customer
calibrator signal relative to 100 (Maximum Signal-Minimum Signal)
the master curve. Spread (%) =
Mean Signal
Mean Calibrator Signal

CSI = -1
Expected Signal Based on the Master Curve
Delta Mean Calibrator 2 Signal x Master Calibrator 1 Signal

-1
Ratio 1 =
Mean Calibrator 1 Signal Signal x Master Calibrator 2 Signal
• Delta Ratio 1 is the ratio for calibrators 1 and 2.
CALIBRATION REPORTS Discuss calibration reports

and identify the cause of
The calibration report status of “Complete” indicates a mathematically successful unsuccessful calibrations.
calibration.
NOTE: A calibration should be verified by processing Quality Control

fluids.
If a calibration is unsuccessful, the Calibration Report status will state that the
calibration has failed and will provide a failure condition.
• A failed calibration causes the assay to become uncalibrated.
• A calibration must be successfully processed or a previous calibration

restored before results can be calculated for samples or control fluids.
NOTE: Additional copies of calibration reports may be printed from

Options & Configuration > Review/User Calibrations > Review
Calibrations > Print Cal Report.
Discuss failed calibrations

and provide examples of
failed calibration reports.
Successful Calibration Report
Unsuccessful Calibration Report
Direct participant to EXERCISE B: CALIBRATION

complete the calibration
exercise in their participant 1. Collect your calibration reports from the printer:
guide.
a. Were the calibrations successful? _____Yes _____No
b. According to the calibration report, what reagent lot number did you
calibrate for FSH?______________________________
a. Display the onscreen calibration curve for FSH.
b. What is the concentration for Master Calibrator 2 (M2)?___________
3. Program and run the Quality Control fluids provided by your instructor to
Explain that a calibration is verify the calibrations for the assays you completed in Exercise A.
verified when the QC is in
range. 4. Use the Control Package Inserts provided by your instructor to evaluate the
acceptability of your calibrations.
5. Review the failed calibration report provided by your instructor. What is a

possible cause of the failure for each calibration?
_________________________________________________________
_________________________________________________________
Exercise completed satisfactorily:____________________________________
Participant:______________________________________________________
Date:___________________________________________________________
Instructor:_______________________________________________________
Date___________________________________________________________
USER CALIBRATIONS Discuss how to manually

enter a calibration.
Calibration parameters may be manually entered in the event of data loss.
• Manually entered calibrations are identified as user calibrated.
• Results calculated from User Calibrations are coded with UC.
• Following manual entry of the light units, the system performs quality
checks and indicates if the calibration is successful or unsuccessful.
• A calibration curve is generated and may be viewed on the Review Cal

Detail screen.
• Following manual entry of successful calibration parameters, the system

will automatically enter the current date and time in the date and time fields.
• Calibration expiration is determined from this time.
NOTE: Date and time should be entered when the actual calibration
was performed.
• Date and time fields should be modified prior to selecting Return/Save.
To manually enter a calibration, go to:

Calibrations
2. Touch User Calibrate.
3. Select the reagent lot number.
4. Enter the light units, and change the current date and time.
Explain that results can be RECALCULATE RESULTS

recalculated if there is a valid
calibration. • Results from patient and control samples processed following a failed
calibration do not have to be processed again.
• Light units are saved in memory.
• Results may be recalculated if there is a valid calibration using the

same reagent lot.
• Recalculation must be done on the same reagent lot as that of the

failed calibration.
• Results can only be recalculated once.
• Only “No Result” and “NC” (Not Calibrated) coded results can be
recalculated.
• After recalculation, results will be coded RR (Recalculated Result) and

ED (Edited Result).
• Additional flags and codes may be assigned.
• Results from User Calibrations cannot be recalculated.
• Only components of derived tests can be recalculated.
• The derived test will be automatically calculated from the new

component results.
• RR will not be assigned to the derived test.
NOTE: Enable the recalculation feature prior to recalculating results.

Go to: Options & Configuration > Enter access code > Configure
System > Sample/Result Options > Recalculate Results > Enable
To recalculate results, go to:
1. Enter information about the record(s) you wish to locate.

search criteria.
3. Select “No Result” records with NC codes to recalculate.
4. Touch Recalculate Results and then touch Yes to confirm the

recalculation.
MODULE 11 SYSTEM CONFIGURATION/ E-CONNECTIVITY®
MODULE 11
System Configuration/
e-Connectivity®
• Identify the configurable features of the system.
• Locate additional details about configurable system features using the OCD
reference documentation.
• Configure analytes, reports, system processes, and e-Connectivity®.
• Configure a system for automatic two-way data exchange and remote State that this module takes
connectivity. approximately one hour to
complete.
SKILLS CHECKS
In this topic, you will complete exercises on analyte configuration, report
configuration, system processing, and e-Connectivity®.

Guide: Chapter 2, System Overview and Chapter 11, Configuring and
Customizing Your System; and the Maintenance and Diagnostics Guide,
Chapter 7, Remote Connectivity.
SYSTEM CONFIGURATION/ E-CONNECTIVITY® MODULE 11
OVERVIEW OF OPTIONS & CONFIGURATION
Explain how Options & • The Options & Configuration features enable you to set defaults for your
Configuration is organized. system, customize many system features, and perform system services.
• Perform most of these procedures on an as-needed or periodic basis, as

they are not part of routine system operation.
• Some Options & Configuration features change parameters that affect

assay processing. Therefore, you cannot select them if the system is
sampling or processing assays.
NOTE: Some Options & Configuration features will require the access
code 68370668 for full functionality.
Of the numerous features within Options & Configuration, some are used
frequently, but most are set during the installation of the system and are not
changed.
• The features are organized into four categories:
• Analyte Data: Features that impact the calculation of the assay

results.
• Calibration Data: Features that affect the outcome of calibration

results.
• System Setup: Features that impact the mechanical processing of

assays.
• System Services: Selections for creating periodic duplicate copies of

system data.
• The four main categories are broken down into functions.
• All of the functions begin by touching Options & Configuration on the

Main Menu or by touching its mini-button.
• Enter the access code for full functionality.
• Use the Help screens and prompt line to perform the task.
MAIN COMPONENTS OF THE OPTIONS & CONFIGURATION

SCREEN
Analyte Data Review the main
Configure Delete Analyte removes all data and associated components of the Options &
Analytes buttons for analyte. Configuration screen.
Select reporting units.
Select equation to calculate derived tests.
Enter name as it appears on reports and screens.
Enter reference and supplementary ranges.
Enter correlation multipliers.
Configure reflex processing.
Configure dilutions.
Calibration Data
Review/User Review Dynamic Range.
Calibrations
View lot-specific calibration data.
View 25 calibrations per assay.
View Master Curve data and the lab-processed

calibrator light units.
Restore calibrations.
Mark primary calibrations.
User calibrate.
Reprint calibration reports.
System Setup
Configure Select printer(s).
Report
Control Set report type defaults.
Configure LIS to upload results or download requests.

Configure Set Date/Time.
System
Configure sound and screensaver.
Enter system name.
Configure PSID for bar code use.
Enable Sample Results Options.
Review data logger.
Configure e-Connectivity® and Ethernet.

Configure Enable Auxiliary Tip Supply.
Subsystems
Select sample cup size.
Configure Set printer and LIS port communication.
Ports
System Services
Usage Review, print, or reset current and cumulative well
Inventory usage data.
Perform Create QC, calibration, and/or configuration backup

Backup/ diskettes.
Archive
Create system archive diskette for result records.
Access Disk Format a diskette.
File Services
Display a directory from a fixed disk or
floppy diskette.
OPTIONS & CONFIGURATION FUNCTIONS Review Analyte Data

functions.
Begin the following functions with steps:
Configure Analytes > Select a body fluid and assay > Review/Edit
Analyte Data
Mention that the access
code must be entered before
• Select unit of measure > Conventional or Alternate. each function.
• View the precision and significant digits.
• Customize the assay name on reports and screen menu.
• Set the default number of wells run per assay. Note that Alternate Units is
selected for the U.S.
• Set the default number of wells processed per calibrator level.
• Enter a reference range.
• Enter a supplemental range.
• Enter a correlation multiplier / user adjustment parameters.
• Configure result text and ranges for semi-quantitative assays.
• Select derived test calculation for FT4I and FT3I > select equation.
Begin the following functions with these steps:
Configure Analytes > Select a body fluid and assay > Review/
Edit Analyte Data > Configure Reflex Processing
• Automatic Ordering of the Same Assay Based on Results > Low / High
Range.
• Automatic Ordering of Selected Assays Based on Results > Low / High

Range.
Configure Analytes > Select a body fluid and assay > Review/Edit
Analyte Data > Configure Dilution
• Enable Reflex Dilution > Select ON > Enter Reflex Dilution Factor.
Note that Standard Dilution • Set Default Dilution Factor > Enter Standard Dilution Factor.
is typically disabled.
Review/User Calibrations > Select a body fluid and assay >

Review Calibrations
• List the last 25 calibrations for an assay.
• Reprint a Calibration Report.
• Remove a Calibration from Memory > Delete Calibration.
• Restore a Calibration to Current Status > Select Calibration > Restore.
• Mark a Calibration as Primary to use when Automatic Lot Switch occurs.

Review Calibrations > Review Cal Detail
• Display Light Units and Prediction Curve.
• Display Quality and Curve Shape Parameters > View Cal Parameters.
• Display Light Units for Each Calibrator Replicate > View Replicates.
Review/User Calibrations > Select a body fluid and assay > User
Cal
• Manually enter calibration data (light units).

Review Calibrations > Review Cal Definition
• Display and edit Dynamic Range.
• Review lot-specific calibration data for each reagent lot.
Configure System
• Configure Sound / Screensaver.
• Set Date/Time and Select Format.
• Assign a Name to the System.
• Configure bar code use > PSID (Positive Sample Identification).
• Review data logger files.
• Configure e-Connectivity > Configure data exchange with OCD at the

schedule you specify.
• Enable Result Recalculation > Sample Result Options > Enable.
• Archive Records > Sample Result Options > Result Record Retention >
Enable.
Configure Subsystem
• Select sample cup size.
• Enable/disable Auiliary Tip Supply.
Configure Report Control
• Select printer on which to print reports.
• Select printer On or Off.
• Select report defaults.
• Receive download request On/Off.
Begin each of the following functions with these steps:
Configure Ports > Select Printer or Lab Computer
• Setting printer communication parameters.
• Setting LIS communication parameters.
Usage Inventory
• Review, print, or reset current and cumulative well usage data.
Perform Backup/Archive
• Make periodic backup diskettes of system data and configuration.
• Archive results to a system diskette.
Access Disk File Services
• Display a directory of a diskette.
• Format a diskette.
• Copy a file from a diskette.
• Display a directory of the fixed disk.
• Copy a file from the fixed disk.
EXERCISE A: OPTIONS & CONFIGURATION FUNCTIONS

1. Verify that the units for Progesterone are set to Alternate.
2. Enter a reference range for TSH of 0.465 - 4.68 μIU/mL.
3. Enable reflex dilution for Estradiol (E2), then enter a Reflex Dilution factor
of 5.
4. Reprint a calibration report for the current lot of TSH.
5. Display the light units and the prediction curve for the current lot of FT4.
6. Verify that the date and time are correct.
7. Verify that the system is set to send laboratory and lab computer reports.
8. Verify that the current setting for the sample cup is 2 mL.
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
E-CONNECTIVITY®
OVERVIEW
What is e-Connectivity®? Explain the function of the

e-Connectivity® feature.
A feature that provides the capability of real-time, secure, two-way interactive
connection between an enabled VITROS® ECi/ECiQ Immunodiagnostic System
and Ortho Clinical Diagnostics (OCD) Technical Support.
• Using an analog telephone line and a modem, a Virtual Private Network Explain the features of
(VPN) is installed to establish a secure connection between an enabled e-Connectivity®.
ECi/ECiQ System and OCD Technical Support.
• Up to four ECi/ECiQ Systems can be connected through a single VPN and

modem.
Demonstrate:
What are the features of e-Connectivity®?
The Remote Connectivity
Automatic transfer of data regarding multiple aspects of system performance to status icon indicates Remote
Technical Support for real-time analysis. Connectivity session status.
• Access to the ECi/ECiQ System for a Technical Support representative to The Notification icon
view system status, configuration, inventory, and condition code information indicates that software has
so that technical challenges can be solved more efficiently. been downloaded to the ECi/
ECiQ System.
• Access to your ECi/ECiQ System for remote control operation by an OCD
Technical Support representative so that technical challenges can be Touching the Start
solved more efficiently. e-Connectivity button
allows the user to establish a
• Automatic download of system software with notification that the software remote connectivity session
updates have been received by the ECi/ECiQ System. and start remote diagnostics
with Technical Support.
What does your ECi/ECiQ System require to utilize the e-Connectivity®
feature?
• Communication hardware installed by a Field Engineer.
• An analog telephone connection.
CONFIGURE THE SYSTEM FOR AUTOMATIC TWO-WAY DATA EXCHANGE
Explain how to configure the • When data exchange is enabled, your system will connect to Technical
system for automatic two- Support at the day and time configured for the Data Exchange Schedule.
way data exchange.
• Both the e-Connectivity® and Ethernet screens must be configured to
enable e-Connectivity®.
• The Ethernet screen is configured by your Field Engineer when the

communication hardware is installed.
• When Remote Connectivity is enabled and the e-Connectivity and

Ethernet screens are configured to enable e-Connectivity®, the Start
e-Connectivity button on the main Diagnostics screen becomes available
for selection to establish a Remote Connectivity session with Technical
Support.
NOTE: Use the time format defined on the Options & Configuration >
Configure System screen.
To configure the system for automatic two-way data exchange, go to:
Options &Configuration > Configure System > e-Connectivity >

Enable Data Exchange > Enable Remote Connectivity
1. For frequency, touch Daily, Weekly, or Monthly.
2. If Daily is selected, for Time of the Day, type the time using the current
time format, then press Enter.
NOTE: If you do not enter the second separator symbol (:) and the
seconds, the system will insert 00 for seconds.
3. If Weekly is selected, for Day of Week, touch the appropriate day of the
week.
4. If Monthly is selected, for Day of the Month, type a number from 1 to 28,
then press Enter.
NOTE: An entry of 1 to 28 is required because each month has a

minimum of 28 days.
Explain how to initiate a INITIATE A REMOTE CONNECTIVITY SESSION

remote connectivity session.
• After initiating a session by touching the Start e-Connectivity process
button, the button changes to End e-Connectivity and the e-Connectivity
icon on the status console changes from gray to green, indicating that the
remote connectivity session has been established with Technical Support.
• A remote connectivity session will not affect the operational status of the
ECi/ECiQ System. All system functions are available.
To initiate a Remote Connectivity session, go to:
Diagnostics > Start e-Connectivity > OK
Explain how to enable a ENABLE A REMOTE SERVICE SESSION

remote service session.
• A remote connectivity session must be established prior to enabling a
remote service session.
• Samples cannot be processed while in the Remote Service Mode.
• The Remote Service Mode dialog box will continue to be displayed until you
end the remote diagnostics session.
• The e-Connectivity status icon returns to gray without a background on the

Status Console to indicate that the remote connectivity session and remote
diagnostics with Technical Support has ended.
To enable a Remote Service session, go to:
Diagnostics > Remote Service
1. Touch Cancel to end the session.
2. Touch End e-Connectivity to end the remote connectivity session.
EXERCISE B: SYSTEM CONFIGURATION AND

E-CONNECTIVITY®
Before You Begin
• This exercise concentrates on the features that are commonly applied in

various laboratories.
• As you read through the questions below, think about how the feature is
applied in your laboratory. If you are interfaced many of the features can
be performed from your laboratory computer system, and you would not
configure the system for the task.
• If you are working with a partner and you both have little interest in the
feature being discussed, you may skip the question and move on to the
next.
• Using step-by-step procedures on pages 11-5 to 11-9 of this guide,

complete the tasks in this exercise. Be sure to read the Prompt Line
and use Help. If you need more help to complete the task, refer to
the Operator’s Guide: Chapter 2, System Overview and Chapter 11,
Configuring and Customizing Your System, and the Maintenance and
Diagnostics Guide: Chapter 7, Remote Connectivity.
Analyte Configuration Scenario
1. Verify that the units for TROPI are μg/L.
2. Configure your ECi/ECiQ System to calculate FT4 test results as ng/dL.
3. You would like the system to flag FT4 results outside the critical values
below. Enter these values into your ECi/ECiQ System:
0.400 - 5.00 ng/dL
NOTE: The Supplementary Range may be used in any manner the

laboratory chooses. It is commonly used for critical or panic values.
4. Customize your patient report so that TT4 results will print next to the
assay name as shown: T4, Total.
5. Change the appearance of the TT4 analyte button on system screens as

shown: TotT4.
6. Your three brand new ECi/ECiQ Systems have recently been installed.
Upon completion of their first calibrations, you begin comparing calibration
reports. You then realize you do not know which report came from which
system.
Answer:
• What could have been done to prevent this inconvenience? ________
_______________________
8.a. Enter the System Name.
7. You cannot hear the Condition Code alerts when you are working across
the room from the system. Adjust the volume.
8. The system is failing to pick up a tip as required to perform sample

dilutions. Ensure that the Auxiliary Tip Supply is enabled.
9. Your laboratory has begun using new pre-printed bar code labels on your
sample containers. There are some difficulties processing the first samples
labelled with these bar codes. What can you do to troubleshoot the
problem?
10. Print the current Well Usage Report. How many wells were used to
process STATs for the TropI assay?
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
MODULE 12 SYSTEM TROUBLESHOOTING
MODULE 12
System Troubleshooting
• Discuss and observe normal operations of the subsystems.

Supplies Needed
• Investigate possible causes of subsystem issues.
• Torx™ driver
• Describe how Intellicheck® Monitoring is used to generate verification data.
• Proboscis Liners
• Identify the main components of the Diagnostics screen.
• Used SR pack(s)
• Specify when and how to use MEDs successfully.
• Bleach
• Use MEDs to recreate the path of the well through the system.
• Mirrors
• Perform basic troubleshooting using MEDs.
• Exacto™ knives
SKILLS CHECK
In this topic, you will complete an exercise in system troubleshooting.
NOTE: For more information on this topic, refer to the Maintenance and
Diagnostics Guide: Chapter 6, Troubleshooting, Chapter 7, Operator State that this module takes
Diagnostics, and Chapter 8, System Diagnostics. approximately two hours to
complete.
SYSTEM TROUBLESHOOTING MODULE 12
Review General Information. GENERAL INFORMATION

SYSTEM CYCLES
The computers of the VITROS® ECi/ECiQ System coordinate the movement of

all hardware components in 40-second cycles.
SENSORS
There are three main types of sensors:
• Hall Effect (magnetic): Used in the Incubator to detect the home positions
of the Inner and Outer Rings.
• Pressure: Used in metering pumps.
• Optical: These are the most numerous.
• A light-emitting diode (LED) and a photosensitive transistor are housed

in two adjacent columns.
• The phototransistor detects the amount of light from the LED and
produces a corresponding voltage.
• A gap between the two columns allows the passage of an opaque flag,
which is an extension of a moving part.
• As the flag passes through the sensor, the voltage changes. The
computer system uses this information to follow the movement of
hardware components.
The computer system is able to track the position and motion of moving parts
through the use of sensors.
1
3
1 Flag
2 Sensor
3 Flag in Sensor
SHUTTLES
There are three shuttles in the system: Point out the location of the
shuttles.
• Reagent Pack Shuttle: Loads reagent packs into Regent Supply.
• Reagent Well Shuttle: Transfers a Microwell™ from Reagent Supply to

the Incubator.
• Incubator Well Shuttle: Holds Incubator Well Weight and Incubator

Reference System (IRS).
THEORY OF OPERATION
SAMPLING CENTER
Review Theory of Operation: Sample Supply Subsystem

Sampling Center.
2
1
9
8
6 4
5
1 Universal Sample Bar Code Reader

2 Tip Disposal Chute/Cup Retainer
3 Tray Positioner
4 Tray Transport Carrier
5 Retainer Plate
6 Sample Tray Conveyor (not visible)
7 Universal Sample Tray
8 Tube Length Sensor
9 Tube Diameter/Home Sensor
Sample Supply Sequence
1. A magnetic drive Sample Tray Conveyor moves the Tray Transport Carriers
counterclockwise using two “like pole” magnets.
2. Underneath each Tray Carrier is a Lower Transport with a sensor flag. As

a Universal Sample Tray moves past the Sample Metering area, this flag
passes through a sensor indicating the tray is ready to be brought to the
Sample Metering Station.
3. The drive motor reverses and moves the Sample Tray clockwise to the Tray
Positioner.
4. The Tray Positioner stops the tray and holds it as it is rotated. The home
position of the Sample Tray is determined when the tray flag between tube
position 9 and 10 is in the Tube Diameter/Home Sensor. This sensor is the
upper of the two next to the Universal Sample Bar Code Reader.
5. The Universal Sample Bar Code Reader reads the Tray ID Bar Code. If the
Tray ID is correct, the bar codes for the samples are read.
6. A Tube Diameter Flag is at the bottom of the spring clip which holds the
sample container side to side in each tray position. As the flag passes
through the Tube Diameter/Home Sensor, the Tray Positioner adjusts the
tray position to allow the Sample Metering Proboscis to enter the center of
the sampling container.
SAMPLE METERING
Sample Metering Sequence
1. Tip Pickup
a. The Sample Metering Pump moves to its home position where no

pressure or vacuum is generated within the pump. The Sample
Metering Arm swings out over the disposable tip in the sample tray. A
tip will be taken from the Auxiliary Tip Supply if a previous condition
occurred, such as a “No Tip” code.
b. A valve within the pump opens to allow compressed air from the
Compressor Subsystem to flow through the Sample Metering
Proboscis. The Pressure Transducer monitors this pressure.
c. The Proboscis moves down into the tip, causing the air pressure to
change as the tips seals on the Proboscis.
d. The drive motor reverses, raising the Sample Metering Arm and
moving it out over the sample container.
2. Sample Aspiration, Dry Level Sense
a. As the proboscis lowers into the sample container, the tip reaches the
fluid, causing the Pressure Transducer to register a pressure change.
b. The Sample Metering Pump generates a vacuum and fluid is

aspirated. The first sample aspirated will be 10-80 μL (depending
on the assay) plus the minimum fill volume required for the sample
Discuss the Smart Metering container.
feature.
Tip moves down to search for
sample fluid, stopping when a
positive pressure spike is detected,
indicating the tip has touched fluid.
Tip minimally immersed in sample.
Fluid flows into tip end.
Prime is performed to change the

meniscus from negative to positive,
preparing for dispense.
NOTE: The rate of descent of the Proboscis into the fluid is determined
by the diameter and height of the container.
Demonstrate how to change

the Proboscis Liner, Part
c. If unexpected pressure occurs during the aspiration, a condition code Number J08323.
is posted, alerting the operator. A high pressure code may indicate
the presence of a clot, and the fluid is expelled back into the sample
container. A low pressure code may indicate bubbles in the sample or
insufficient sample volume.
Instruct participants to
d. Following successful aspiration of sample, the prime volume is change the liners on their
dispensed back into the container to reverse the meniscus in systems.
preparation for dispensing the sample into the well.
e. The Proboscis moves up out of the sample container.
3. Sample Dispense
a. The Sample Metering Arm moves over the well in the Outer Ring of
the Incubator.
b. The Sample Metering Proboscis moves to the preset distance above

the bottom of the well.
c. Positive pressure is created by the Sample Metering Pump forcing

fluid out of the tip and into the well.
d. If no other assays are to be processed for the sample, the Proboscis

moves to the Tip Eject Station and ejects the tip into the Solid Waste
Container.
e. If another assay is to be processed, the Sample Metering Arm moves

over the sample again and repeats sample aspiration and dispense
into another well. Assays will be metered in the order of the sample
volume required: low volume first, high volume last.
Pressure from the bellows pump

forces fluid out of the tip into the
well.
The fluid is dispensed in a

“Touch Off” mode.
As fluid is dispensed, the tip

tracks up to maintain minimal tip
immersion.
4. Intellicheck® Technology Verifications Utilized
a. Sample Metering Intellicheck® verifies that no clots, bubbles, short

samples, high and low viscosity, or thin layers of fluid were detected.
b. Dilution Volume Verification verifies the sample and diluent volume in

the dilution well for a specified dilution factor.
REAGENT MANAGEMENT CENTER
Reagent Supply Subsystem
2
1
3
4
9
1 Reagent Carousel
2 Reagent Pack Opener
3 Reagent Well Dispenser
4 Upper Heater
5 Reagent Probe Wash Station
6 Reagent Well Shuttle
7 Inner Load Door
8 Auto-Load Station (Reagent Pack
Shuttle not shown)
9 Reagent Supply Bar Code Reader (not
shown)
Review Theory of Operation: Reagent Supply Sequence

Reagent Management
System. 1. The Outer Load Door is opened and a reagent pack is placed in the Auto-
Load Station. The pack is detected by the Pack Present Sensor.
2. The Inner Load Door opens, the Reagent Pack Shuttle engages the
reagent pack, and the pack is transported onto the Reagent Carousel. The
Inner Load Door closes again to allow the environment of the Reagent
Supply to be maintained at 4-8° C and < 40% RH.
NOTE: Cool air from the Reagent Cooler is forced past a heater
as it passes into the Reagent Supply. The heater controls the
temperature of the air and the humidity, as colder air holds less
moisture than warmer air.
3. The Reagent Supply Bar Code Reader scans the bar code label on the
reagent pack and determines the assay, the lot number, and the unique
pack ID.
4. The reagent pack inventory is taken. The carousel rotates to the Reagent
Well Dispenser position.
a. Well inventory is determined by the Reagent Well Dispenser. The

number of step counts from the home position of the screw is known
and is translated into well count.
b. The Pack Shutter on top of the pack is opened by the Reagent Pack
Opener.
c. The stainless steel probe pierces the seal on the reagent pack. The
fluid level in the reagent bottles is determined by the Reagent Metering
Probe with its capacitance level-sensing capabilities. A change in
capacitance occurs when the probe touches fluid.
5. The Reagent Pack Opener closes the Reagent Pack Shutter.
NOTE: As assays are processed, the software monitors and

updates the inventory.
6. To process an assay, the appropriate reagent pack is rotated by the

Reagent Carousel to the Well Dispense location.
Discuss the sensors in the

7. The Reagent Well Dispenser pushes a well out of the bottom of the current Reagent Well Shuttle. The
well tube in use into the Reagent Well Shuttle. sensor detects if a well is
dispensed or if a double well
push occurred.
NOTE: A condition code is displayed if no well or multiple wells are
dispensed.
8. After sample is added to the well, the Reagent Pack Shutter is opened by
the Reagent Pack Opener.
9. The carousel is rotated until the reagent bottle is underneath the Reagent
Metering Probe, which aspirates fluid.
10. The carousel rotates back to the Reagent Pack Opener so the pack shutter
can be closed. Point out the hardware
components.
11. Empty packs are automatically brought to the Auto-Load Station during the
reagent pack loading process.
a. The Reagent Carousel rotates the position containing the empty pack
to the Inner Load Door. Demonstrate how to unload
and load a reagent pack
b. The Inner Load Door opens, the Reagent Pack Shuttle moves into manually.
the Reagent Carousel and engages the empty pack, and the pack is
moved to the Auto-Load Station.
12. The Inner Load Door closes.
REAGENT METERING
1 Reagent Metering Arm

2 Reagent Metering Arm Horizontal
Position Sensor
3 Reagent Metering Probe
Point out the Reagent

Metering Pump.
Reagent Metering Sequence
1. Reagent Aspiration
a. If the Reagent Metering Pump has been idle for more than two
minutes, the pump is primed before reagent aspiration.
b. The Reagent Metering Arm moves over either Bottle A or B of the

reagent pack. The stainless steel probe pierces the seal on the
Mention that code F02-194 reagent pack.
may occur if the system is
idle. c. The Reagent Metering Probe is always filled with Universal Wash
Reagent.
d. As the Reagent Metering Probe is lowered into the bottle, the

capacitance level-sensing capabilities of the Reagent Metering Probe
are able to detect when fluid is found. The downward motion of the
probe is halted.
e. The Reagent Metering Pump reverses to pull fluid into the probe.
f. The probe is moved up out of the reagent fluid.
2. Reagent Dispense
a. The Reagent Metering Arm moves above the Incubator.
b. The probe is lowered until it is directly above the bottom of the well. Demonstrate the movement
of the Probe Wash in MEDs.
c. The pump creates positive pressure to force the proper amount of
reagent fluid into the well.
d. The Reagent Metering Probe is moved to its home position above the
Reagent Probe Wash Station.
e. The Reagent Metering Pump is primed with Universal Wash Reagent.
f. The Reagent Metering Probe is lowered into the Wash Ring of the
wash station. Eight concentric jets on the Wash Ring deliver Universal
Wash Reagent for complete high velocity coverage of the outside
of the probe. At the same time, the Reagent Metering Pump forces
Universal Wash Reagent through the interior of the probe washing it.
g. A vacuum nozzle facilitates removal of the wash fluid from the

assembly.
h. As the Reagent Metering Probe is raised out of the wash assembly,

air is briefly forced through the probe to remove any foaming effect,
residual wash is removed from the outside of the probe by the vacuum
nozzle.
i. The probe is once again filled with the Universal Wash Reagent and is
again ready to meter reagents.
3. Intellicheck® Technology Verifications Utilized Discuss codes F02-194 and

F02-196.
a. Reagent Metering Verification verifies overall performance of the
Reagent Metering Subsystem. Reagent Aspiration Verification ensures
proper reagent aspiration volumes during processing and provides for
a significant reduction in the potential for aspirating reagent foam.
b. Well Dispense Verification verifies each well dispense is performed.

Automatic Inventory Management tracks, monitors, and provides
status notifications for all reagent packs for inventory, calibration,
open, and shelf expiration.
PROCESSING CENTER
1 Luminometer
2 Well Wash Probe Assembly
3 Signal Reagent Probe Assembly
4 Incubator
The Processing Center consists of:
• Incubator
• Well Wash subsystem
• Signal Reagent subsystem
• Luminometer
The journey of the well through the Incubator is broken into simplified steps and
discussed on the following pages.
Incubator
Review Theory of Operation:
Processing Center - The
Journey of the Well.
2
1
3
9
7 5
6
1 Evaporation Cover
2 Upper Heater Plate (not shown)
3 Incubator Well Shuttle
4 Air Tube
5 Incubator Well Shuttle Position Sensor
6 Lower Heater Plate (not shown)
7 Outer Ring
8 Inner Ring
9 Gear Wheels
Demonstrate the reaction Journey of the Well Through the Incubator

caused by mixing Signal
Reagent with bleach. 1. The Reagent Supply’s Reagent Well Shuttle transfers a well into one of the
Incubator’s Outer Ring’s 60 positions. Position 1 of each ring is marked by
a recessed oval mark on the ring’s housing.
2. The Outer Ring rotates the well to the Sample Metering position, where the
Proboscis dispenses sample into the well.
3. The Outer Ring rotates the well to the Reagent Metering position, where
reagents are added from the reagent pack’s bottles.
4. When the well is not accessed by probes inside the Incubator, it is covered
by the Evaporation Cover, which is suspended from the Incubator Cover. It
reduces evaporation and temperature variability, prevents any interaction
from one well to another, and blocks stray light from reaching the
Luminometer.
5. The well containing sample and labeled antibody rotates in the Outer Ring
for an assay-specific incubation time. Incubator temperature is maintained
at 37° ± 1°C.
6. After incubation, the well is rotated to the Incubator Well Shuttle position.
The Outer Ring’s Lift Pin is a pneumatic solenoid that lifts the well into the
Well Shuttle.
7. The Incubator Well Shuttle moves the well from the Outer Ring onto the
Inner Ring Lift Pin. This stepper motor-driven lift pin lowers the well into one
of the Inner Ring’s 24 transport positions.
8. As the Lift Pin lowers the well, pressure from the Well Shuttle Weight
stabilizes the well, keeping it upright during the transfer.
9. Incubator Intellicheck® Monitoring Utilized:
a. Sample + Reagent Verification confirms after incubation that the

proper sample and assay reagent volumes have been dispensed in
reaction well previously verified during sample and assay processing.
b. This verification is performed by the Well Wash Aspirate Probe.
Well Wash Sequence
10. The well is moved to the Well Wash Position in the Inner Ring. Demonstrate how to replace
the Universal Wash Reagent
a. The Well Wash Probe Assembly is lowered into the well. Aspirate Filter, Part Number
J19057.
b. The longer of the two metal probes aspirates unbound sample and
reagents from the well when a vacuum valve opens. The waste fluid is
carried to the Waste Bottle by tubing.
c. The shorter of the two metal probes dispenses Universal Wash

Reagent heated to 37° ± 1°C into the well.
d. The probe assembly raises enough so the Inner Ring can freely rotate
beneath it.
e. The well rotates within the Inner Ring to allow a complete wash.
f. The Universal Wash Reagent is aspirated from the well again at the
Well Wash Position.
g. Multiple wash steps occur. The number of wash steps depends on the
assay.
11. Well Wash Intellicheck® Monitoring Verifications Utilized:
a. Well Wash Intellicheck® Technology automatically verifies that the

proper volumes of Universal Wash Reagent are dispensed and
aspirated from each reaction well during assay processing. This
verification is performed by the Well Wash Aspirate Probe.
Signal Reagent Sequence
12. The Inner Ring rotates the well to the Signal Reagent position.
a. 100 μL of Signal Reagent A and 100 μL of Signal Reagent B are

dispensed into the well in 50 μL increments to ensure sufficient mixing.
b. Automatic primes will occur during the next assay processing event
(not when the system is idle) if the Signal Reagent Probe has not
dispensed for more than 30 minutes. The Signal Reagent Probe
rotates over the Prime/Purge Station on the Incubator Cover and
performs the prime operation. The primed reagent is aspirated from
the station to the Liquid Waste Bottle.
13. The well is moved to the Well Wash Position in the Inner Ring.
a. The Well Wash Probe Assembly is lowered into the well.
b. The Well Wash Aspirate Probe, which is the longer of the two metal
probes of the Well Wash Probe Assembly, has a level sense extension
device that is used to check the volume of Signal Reagent in the well.
c. The Probe Assembly is raised allowing the Inner Ring to rotate.
14. Signal Reagent reacts with the analyte complex during a 4.5-minute
incubation period within the Inner Ring.
15. Signal Reagent Intellicheck® Technology Verifications Utilized:
a. Signal Reagent Dispense Verification verifies that the proper amount

of Signal Reagent was dispensed into each well. This verification is
performed by the Well Wash Aspirate Probe.
LUMINOMETER
16. The well is rotated back to the Incubator Well Shuttle Position. Demonstrate how to clean
the Fiber Optic Bundle and
17. The Inner Ring Lift Pin raises the well to the Luminometer, which measures calibrate the IRS.
the enhanced chemiluminescence from the well.
a. The Incubator Well Shuttle moves the Incubator Reference System

(IRS) under the Luminometer. The shutter to the Photomultiplier
Tube is opened and three sets of readings are taken. The IRS LED
is activated, and a set of readings is taken with the Luminometer
Reference System (LRS) LED. Finally, a set of dark readings is taken.
The Photomultiplier Tube Shutter is closed again.
b. The IRS is moved back, and the well is moved up under the Fiber
Optic Bundle (FOB).
c. The Photomultiplier Tube Shutter is opened and an initial reading is

taken from the well, and then automatically adjusts the number of
readings taken based on the amount of light from the well. If the light
level is low, 14 readings are taken. If the light reading is high, only five
readings are taken.
d. The IRS readings are used to zero the FOB and maintain consistency
in the Luminometer’s initial calibration. This information is used to
calculate assay values.
18. Luminometer Intellicheck™ Technology Verifications Utilized:
a. The Luminometer performs a self-calibration for each well processed

prior to reading the enhanced chemiluminescence light output.
WELL DISPOSAL Mention LRS and IRS range

warning errors 541-017 and
19. The Inner Ring rotates slightly to move the well from the transport position 541-015.
to the disposal position of the Inner Ring.
20. The Inner Ring rotates the well to the Incubator disposal position, where the
well drops into the Solid Waste container.
DIAGNOSTICS
MAIN COMPONENTS OF THE DIAGNOSTICS SCREEN

Review the components of
Operator Diagnostics
the Diagnostics screen.
Mechanism Actuates and observe the movement of various

Exercise hardware components.
Diagnostics
Briefly describe when to go Used as a troubleshooting tool.
into MEDs. Adjustments Verifies alignment of and adjust the Reagent
Metering Probe.
System Diagnostics (Primarily for Field Engineer Use)
Performance Tests subsystems and selected individual

Tests components.
Adjustments Adjusts subsystems by movement or alignment of

individual components.
Calibrate Tests and calibrates the touchscreen, calibrate the

Subsystems Incubator Reference System (IRS).
View the Digital Analog Converter (DAC) values for

the Luminometer.
System View data logger analysis, software versions and
Information identifications, and an e-Connectivity® status log.
Interface View the configurations and test the functionality of

Tests the serial ports
Process Buttons
Cancel Assays Cancels all sampling and assays in

progress.
Used when MEDs and Adjustments are not

available.
Results are not reported.

Start Initiate two-way data transfer between the
e-Connectivity VITROS® ECI/ECiQ System and OCD Technical
Support.
Remote Allows OCD Technical Support limited access to
Service perform diagnostic and troubleshooting functions.
MECHANISM EXERCISE DIAGNOSTICS (MEDs)
NOTE: The system status must be Ready in order to run samples. If

the status is Inop, go to the Condition Review screen and initialize. If
the system is still Inop, go into Diagnostics > MEDs and initialize the
module affected by the condition code.
Overview
• Diagnostic software that allows you to actuate system components in order

to assure that they are working properly.
• Sampling and assays in process should be completed before entering

MEDs.
• The system will initialize when returning out of MEDs before assays can be
processed.
Golden Rules of MEDs
• Raise the main cover, then the main cover interlock switch.
NOTE: The system cannot process samples routinely with the Interlock
Switch raised.
• Be sure to raise the Well Wash and Signal Reagent Probe Assemblies
before opening the Incubator.
• Reposition the probe assemblies over the Incubator when the Incubator
Cover is open.
• Initialize subsystems first.
NOTE: Do not use the mini-buttons to exit Diagnostics. If you do, the
system will not initialize.
• All sampling and assay processing should be completed before performing

MEDs diagnostic procedures.
• Touch Abort Assays on the Diagnostics screen to cancel sampling

and assays in progress.
• No results will be reported.
• It is always a good idea to touch the Initialize process button at the bottom
of the screen before exercising any components.
• A completed initialization assures all components are in the home

position.
MEDs Build a Screen
• Once a subsystem button is selected from the main MEDs screen, you will
be asked to touch a function button.
• Depending on which function is selected, you will be presented with a line

of options from which to choose.
• Your options choice leads to direction and then destination choices.
• Touch Start to initiate the MEDs test.
EXERCISE A: WELL WALK

NOTE: The purpose of this activity is to give you practice with MEDs, complete the exercise.
reinforce the names of the various subsystems, and recreate the path of
the well through the system.
Before beginning the exercise:
• Enter MEDs.
• Touch Incubator.
• Initialize the Incubator.
• When the Incubator initialization is complete, touch Return to access the

Main Menu and allow the system to initialize.
• When system initialization is complete and the system status is Ready,

begin the exercise.
OPEN THE SYSTEM FOR OBSERVATION
1. Open the main cover of the system.
2. Pull up the main cover interlock switch.
3. Release the Luminometer latch and raise the Luminometer.
4. Prepare to open the Incubator Cover by moving the Well Wash and Signal
Reagent Probe Assemblies to the maintenance position.
5. Open the Incubator Cover.
6. Reposition the Well Wash and Signal Reagent Probe Assemblies over the
open Incubator.
SELECT A REAGENT PACK
Explain why a pack with 7. Touch Diagnostics > Mechanism Exercise Diagnostics >
> 75 wells is needed. Reagent Supply > Display Well Counts.
8. Select a reagent pack with a well count > 75. Record the position of the
pack here: ___________________
9. Touch Return.
DISPENSE A WELL INTO THE WELL DISPOSAL CONTAINER
10. Touch Cycle Dispense.
11. Enter the pack position you recorded in step 7 above.
12. Enter 1 as the tube position from which the well will be dispensed. (Each
reagent pack has four tubes which typically contain 25 wells each when the
reagent pack is new. Some assays contain 13 wells per tube, for a total of
52 wells per pack.)
13. Touch Start. Observe that a well has been dispensed into the Well Disposal
Container by the Reagent Well Shuttle.
MANUALLY PLACE THE WELL INTO THE INCUBATOR
14. Touch Return.
15. Touch Incubator.
16. Touch Outer Ring.
17. Touch Select Position.
18. Enter the Position: 1.
19. Touch the Destination: Well Dispense.
20. Touch Start. Observe that the Outer Ring Incubator Position 1 is at the Well
Dispense Position. Position 1 is characterized by a recessed oval mark on
the Outer Ring Housing.
21. Remove the well you dispensed from the Well Disposal Container.
22. Place the well into position 1 of the Incubator’s Outer Ring.
23. Replace the Well Disposal Container, assuring proper orientation. Explain how to ensure that
the Well Disposal Container
is correctly positioned.
MOVE THE WELL TO THE SAMPLE METERING POSITION
24. Touch the Destination: Sample Dispense.
25. Touch Start. Observe that the well has moved to the Sample Metering
Position. (We will not be dispensing fluids into the well during this exercise.)
MOVE THE WELL TO THE REAGENT METERING POSITION
26. Touch the Destination: Reagent Dispense.
27. Touch Start. Observe that the well has moved to the Reagent Metering
Position. (We will not be dispensing fluids into the well during this exercise.)
MOVE THE WELL TO THE INCUBATOR WELL SHUTTLE POSITION
28. Touch the Destination: Shuttle.
29. Touch Start. Observe that the well has moved to the Well Shuttle Position.
POSITION THE INCUBATOR WELL SHUTTLE TO MOVE THE WELL TO THE

INNER RING
30. Touch the Function: Shuttle.
31. Touch the Option: Move.
32. Touch the Destination: Outer Ring.
33. Touch Start. Observe that the Incubator Well Shuttle moves out over the
Outer Ring.
LIFT THE WELL INTO THE INCUBATOR WELL SHUTTLE
34. Touch the Function: Outer Lift.
35. Touch the Option: Up.
36. Touch Start. Observe that the well has been pushed up into the Well
Weight on the Incubator Shuttle over the Outer Ring of the Incubator.
MOVE THE WELL TO THE INNER RING
39. Touch the Destination: Inner Ring.
40. Touch Start. Observe that the well has moved to the Transport Position of
the Inner Ring of the Incubator.
MOVE THE OUTER RING LIFT PIN TO THE HOME POSITION
41. Touch the Function: Outer Lift.
42. Touch the Option: Down.
43. Touch Start. Observe the Outer Lift Pin has moved down under the Outer
Ring of the Incubator.
MOVE THE WELL TO THE WELL WASH POSITION
44. Touch the Function: Inner Ring.
45. Touch the Option: Select Position.
46. Enter Position: 1.
47. Touch the Destination: Well Wash.
48. Touch Start. Observe that the well has moved to the Well Wash Position.
Position 1 is characterized by a recessed oval mark on the Inner Ring
Housing.
MOVE THE WELL TO THE SIGNAL REAGENT DISPENSE POSITION
49. Touch the Destination: SR Dispense.
50. Touch Start. Observe that the well has moved to the Signal Reagent
Dispense Position. (We will not be dispensing fluids into the well during this
exercise.)
MOVE THE WELL TO THE READ POSITION
51. Touch the Destination: Read/Shuttle.
52. Touch Start. Observe that the well has moved under the Luminometer.
55. Touch the Destination: Inner Ring.
56. Touch Start. Observe that the shuttle has moved over the Inner Ring.
57. Touch the Function: Inner Lift.
59. Touch the Destination: Read.
60. Touch Start. Observe that the well is raised into the Well Shuttle.
MOVE THE WELL BACK INTO THE INCUBATOR
61. Touch the Destination: Home.
62. Touch Start. Observe that the well has dropped down into the Inner Ring.
DISPOSE OF THE WELL
63. Touch the Function: Inner Ring.
64. Touch the Option: Transfer Well.
66. Touch Start. Observe that the well is moved from the Transport to the
Disposal Position of the Inner Ring.
67. Touch the Option: Select Position.
69. Touch the Destination: Disposal.
70. Touch Start. The well falls into the Solid Waste Container.
CLOSE COVERS
71. Prepare to close the Incubator Cover by moving the Well Wash and Signal
Reagent Probe Assemblies to the maintenance position.
72. Close the Incubator Cover.
73. Reposition the Well Wash and Signal Reagent Probe Assemblies over the
Incubator.
74. Lower the Luminometer and latch it.
75. Close the Top Cover of the system.
76. Touch Return until you reach the Main Menu.
EXERCISE A: TROUBLESHOOTING THE SYSTEM

Troubleshoot the system using the condition review screen and MEDs. Create some “bugs” in the
system and ask participants
Note below the problems you have fixed. to diagnose and correct the
problem.
_____________________________________________________________
Possible bugs include:
_____________________________________________________________
1. Power off the touch-
_____________________________________________________________ screen.
_____________________________________________________________ 2. Loosen the cap on the

UWR or Liquid Waste
_____________________________________________________________ Container.
_____________________________________________________________ 3. Disconnect geers from

the Incubator Rings.
_____________________________________________________________
4. Remove the Solid
_____________________________________________________________ Waste Container.
_____________________________________________________________ 5. Loosen the Proboscis
Liner.
_____________________________________________________________
6. Cover the FOB on the
_____________________________________________________________ Luminometer.
Participant:___________________________________________________
Date:________________________________________________________
Instructor:____________________________________________________
Date:________________________________________________________
DAILY REVIEWS / START-UP EXERCISES
This section contains

a series of daily review
exercises designed to
reinforce and assess
Daily Reviews / Start-Up participants’ understanding of
key course concepts. These
reviews can be conducted
Exercises on the morning following
when the topic was covered
or at another time that you
consider appropriate.
CONTENTS
• Performance of daily maintenance procedures.
• Start-up exercises and review questions.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 Daily-1
Direct participants to TUESDAY MORNING REVIEW AND START-UP

complete the Tuesday daily
review and start-up exercise. 1. Perform daily maintenance and document in the Daily Maintenance log.
2. Program and run daily QC for TSH and FT4 using the following IDs:
a. FTHYR1
b. FTHYR2
c. FTHYR3
3. Load the reagent pack provided by your instructor. What is the pack status?
Allow approximately 15-20
minutes to complete this ________________________________
activity.
4. Program and run the following samples by Tray ID programming:
Tray ID Cup Sample ID Tests/Panel

Use Any 1 4001 TSH
Debrief the exercise. 2 4002 Panel: HEART
3 4003 Panel: THYRD
4 4004 HBsAg
5 4005 B-hCG - Dil x20
Daily-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
WEDNESDAY MORNING REVIEW AND START-UP Direct participants to

complete the Wednesday
1. Perform daily maintenance and document in the Daily Maintenance log. daily review and start-up
exercise.
2. Program and run daily QC for TSH and FT4 using the following IDs:
a. LEVEL1
b. LEVEL2
c. LEVEL3 Allow approximately 15-20

minutes to complete this
3. Complete the following: activity.
a. What is the Open Expiration Date for the current lot of TROPI?
_____________________________
b. When will the calibration expire for the current lot of TROPI? Debrief the exercise.
_____________________________
c. What button was selected to find the calibration expiration?

______________________________
4. Program and run the following samples by Tray ID programming:
Tray ID Cup Sample ID Tests/Panel

Use Any 1 5001 Panel: HEART
2 5002 Panel: THYRD
3 5003 TSH, FT4
4 5004 B-hCG: STAT, 2 reps
Rep 1 - straight
Rep 2 - Dil x10
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 Daily-3
Direct participants to THURSDAY MORNING REVIEW AND START-UP

complete the Thursday daily
review and start-up exercise. 1. Perform daily maintenance and document in the Daily Maintenance log.
2. Record the current inventory levels for:
a. Signal Reagent:________________
Allow approximately 15-20
minutes to complete this b. Universal Wash Reagent:_____________
activity.
a. Reprint the Calibration Report for the current calibration of FSH.
b. Record the Dynamic Range for B-hCG:______________
Debrief the exercise.
Daily-4 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
APPENDIX A MICROWELL™ TECHNOLOGY
APPENDIX A
MicroWell ™ Technology
CONTENTS
• Reaction sequence within the well.
• Comparison of immunometric and competitive assay methodologies.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 A-1
MICROWELL™ TECHNOLOGY APPENDIX A
REACTION SEQUENCE WITHIN THE WELL
Immunometric Competitive
(Sequence varies with
assay.)
1 2
1. Wells are coated and stored in reagent packs.
3 3
2. Sample is added to the well by the Sample Metering System.
4 5
3. Reagent from the reagent pack is added by the Reagent Metering

Subsystem as follows:
- Labeled antibody for many immunometric assays.
- HRP-labeled competitive analyte for many competitive assays.
1 Streptavidin
2 Coating
3 Analyte
4 Biotin-labeled antibody
5 HRP-labeled competitive analyte
A-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
(Sequence varies with assay.)
4. Analytes bind to the antibodies, and the antibodies bind to the well wall
during incubation of the immunometric assays.
1
2
Reagent from the reagent pack is added by the Reagent Metering
Subsystem as follows:
- HRP-labeled conjugate for immunometric assays
- Antibodies for competitive assays.
4
5. Binding occurs during incubation. The well is shuttled to the Inner Ring.
1 HRP-labeled conjugate
2 Antibody
3 Unbound conjugate
4 Unbound HRP-labeled competitive analyte
MICROWELL™ TECHNOLOGY APPENDIX A
6. Unbound reagents are removed following the addition of Universal

Wash Reagent at the Well Wash Station.
1 1
7. Signal reagent is added by the Signal Reagent Subsystem.
2
8. Signal reagent reacts with the HRP/analyte complex creating a light
signal measured by the Luminometer.
9. Results are reported and the well is disposed of into the Solid Waste
Container.
1 Signal reagent
2 Reacting luminescent signal reagent
NOTE: Information regarding dispense volumes of immunometric and

competitive assays is located in Intructions for Use, available at
www.orthoclinical.com.
A-4 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
CALIBRATION MODEL
Streptavidin on well wall Coating on well wall
Antibody from reagent pack Antibody from reagent pack
Analyte Analyte
HRP-labeled antibody from reagent pack HRP-labeled competitive analyte
Reacting luminescent signal reagent Reacting luminescent signal reagent

Nonreacting signal reagent Nonreacting signal reagent
100000
6000
10000
5000
1000 4000
Light Light 3000

100
Units Units
10
2000
1000
1
0 2.5 4.7 9.9 15.1 23.5 30.8
0 0.01 0.1 1 10 100
Concentration Concentration
The light units produced are directly proportional to The light units produced are inversely
the amount of analyte in the sample. proportional to the amount of analyte in the
sample.
Examples of Immunometric Assays: Examples of Competitive Assays:
B-hCG CK-MB FERR E2 FT3 FT4
FSH LH PROL PROG TT3 TT4
TSH T3U
APPENDIX B IMMUNOASSAY CALIBRATION THEORY
APPENDIX B
Immunoassay Calibration
Theory
CONTENTS
• Calibrator Value Assignment.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 B-1
IMMUNOASSAY CALIBRATION THEORY APPENDIX B
MASTER CALIBRATION
B-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
CALIBRATOR VALUE ASSIGNMENT
Successful Calibration Report (Quantitative)
Successful Calibration Report (Qualitative)
APPENDIX C DIAGNOSING CODES
APPENDIX C
Diagnosing Codes
CONTENTS
• Examples of condition codes for Sample Metering, Reagent Management
Center, and Processing Center.
• Possible causes of condition codes for each subsystem.
• Recommended action(s) to resolve condition codes.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 C-1
DIAGNOSING CODES APPENDIX C
SAMPLE METERING
This section identifies examples of condition codes specific to the Sample
Demonstrate how to
Metering Subsystem.
replace the Sample Metering
Proboscis Liner:
Condition Description Possible Causes Things to Do
Part No. J08323 Code
E01-052 High Pressure Sample fluid has a Check the sample and
E01-055 clot or particles. remove fibrin or clots.
Disposable tip is Replace the tip and

plugged. reprocess the sample.
Demonstrate how to perform
a Sample Metering Leak Test Proboscis or Clean the outside of the
in Diagnostics. tubing is plugged. Proboscis, if necessary.
Replace the Sample

Metering Proboscis Liner.
E01-164 Low Pressure Leak in the tubing. Inspect the tubing and
connections.
Disposable tip is
damaged. Replace the tip and
reprocess the sample.
Clean the outside of the

Proboscis, if necessary.
Replace the Sample

Metering Proboscis Liner.
E01-159 No tip pickup No disposable tip Replace the tip and
is present. reprocess the sample.
Tip did not seal on Troubleshoot for low

Proboscis. pressure codes.
E00-005 Metering Arm Top cover open. Close top cover.
E00-014 movement
Obstruction of Inspect path movement for
Metering Arm obstructions.
preventing
movement. Inspect and clean the
optical sensor.
Sensor obstructed
or malfunctioning.
C-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
REAGENT MANAGEMENT CENTER

This section identifies examples of condition codes specific to the Reagent
Management Center.
Reagent Supply

Code
A03-095 Regent Well Pressure switch Check for related
A01-004 Shuttle or air supply is condition codes.
detected more malfunctioning.
wells than Check the connection of
expected Regent Well the tubing on the Well
Shuttle Detection Dispenser.
Sensor is
obstructed or Clean the Reagent Well
malfunctioning. Sensor.
A02-024 Reagent Pack Obstruction of the Inspect the path of

Shuttle did not Reagent Pack movement for
reach home Shuttle preventing obstructions.
position movement.
Manually move the pack
shuttle to home by
turning the black knob
on the outside of the
Reagent Supply near the
Auto-Load Station.
A00-149 Reagent Obstruction of Inspect the path of
Carousel did not Reagent movement for
reach next Carousel. obstructions.
position
location, Motor Reset Reagent Carousel
Flag Failure in MEDs.
Demonstrate how to perform Reagent Metering

the Arch and Rave tests in
MEDs. Condition Description Possible Causes Things to Do
Code
F00-005 Reagent Metering Top cover open. Close top cover.
F00-016 Arm movement
Obstruction of Inspect the path
the Metering of movement for
Arm preventing obstructions.
movement.
Inspect and clean the
Sensor is optical sensor.
obstructed or
malfunctioning.
F02-194 Reagent Metering Reagent Metering Perform Rave and
F02-196 performance test Probe is plugged Arch test in MEDs and
outside of or Reagent inspect DRD Pump for
acceptable limits Metering Pump is leak and crystals.
malfunctioning.
F01-190 Reagent Metering Empty reservoir Check the tubing and

reservoir bottle bottle. connectors for leaks or
did not fill damage.
PROCESSING CENTER CONDITION CODES

This section identifies examples of condition codes specific to the Processing
Center.
Incubator

Code
G00-039 Outer Ring Obstruction Inspect the path of
movement of Outer Ring movement for
preventing obstructions.
movement.
Inspect the Incubator for
debris; clean if necessary.
G01-039 Inner Ring Obstruction of the Inspect the path of

movement Inner Ring movement for
preventing obstructions.
movement.
Inspect the Incubator for
debris; clean if necessary.
Use MEDs to lift the Inner

Ring Lift Pin. Clean the
surface, if necessary.
Inspect the Well Shuttle

Weight.
G04-005 Incubator Well Obstruction of the Inspect the path of
Shuttle Well Shuttle movement for
movement preventing obstructions.
movement.
Inspect the optical sensor.
Sensor is
obstructed or Use MEDs to exercise
malfunctioning. the Lift Pins. Clean the
surface, if necessary.
Mention that you can follow Fluidics

the same steps to correct
errors for a vacuum in the Condition Description Possible Causes Things to Do
waste bottle. Code
1C0-041 Universal Wash Universal Wash Inspect and tighten the
Reagent Reagent bottle Universal Wash Reagent
pressure cap is not tight. bottle cap.
out-of- range
Pressure Switch Move switch to ON
in Off position. position.
Tubing is not Inspect tubing connected

connected or is to Universal Wash
damaged. Reagent bottle.
Signal Reagent

Code
K00-015 Signal Reagent Obstruction of Inspect the path
Carousel SR Carousel of movement for
movement preventing obstructions.
conditions movement.
Inspect the optical
Sensor obstructed sensor.
or malfunctioning.
Well Wash

Code
J01-065 Well Wash Aspirate tubing or Verify the level sense
subsystem valve is plugged extension on the Well
detected a high or damaged. Wash Aspirate Probe is
volume of Well not bent or dirty.
Wash Level sense
extension on Purge the Well Wash
the Well Wash subsystem using MEDs.
Aspirate Probe is
damaged.
Luminometer

Code
H00-221 Luminometer in Luminometer is Verify the Luminometer is
raised raised above the seated correctly.
position Incubator.
IC0-045 Luminometer Air flow to the Verify the temperature in
temperature is system may be the laboratory is within
out-of-range blocked. operating specifications.
541-016 Luminometer Luminometer Clean the Fiber Optic

541-018 reference optical system is Bundle (FOB) and then
reading is out- dirty. perform the IRS
side of normal Luminometer Calibration.
or acceptable Luminometer is
operating range not calibrated Check for Incubator Well
correctly. Shuttle position condition
codes.
Stored
Luminometer Exercise the Incubator
values are invalid. Well Shuttle in MEDs,
observing the position of
Incubator Well the IRS.
Shuttle is not
positioning the
Incubator
Reference system
(IRS) correctly.
APPENDIX D INTELLICHECK® TECHNOLOGY
APPENDIX D
Intellicheck® Technology
CONTENTS
• Intellicheck® Technology for Subsystems and Processes.
• Notifications from Intellicheck® Technology.
• Result Intellicheck®.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 D-1
INTELLICHECK® TECHNOLOGY APPENDIX D
INTELLICHECK®
The system uses Intellicheck® Technology, a proprietary technology of Ortho
Clinical Diagnostics, which is designed to significantly reduce critical errors and
minimize operator intervention. Intellicheck® is an integrated technology.
Process Control is a series of patented and unique technologies that perform,

monitor, and verify diagnostic checks throughout sample processing, assay
processing, and reporting results. When exceptions are detected, Intellicheck®
Technology prevents the reporting of results that may be affected. Intellicheck®
Technology is automatically configured on your system.
INTELLICHECK® TECHNOLOGY FOR SUBSYSTEMS AND

PROCESSES
Intellicheck® Technology monitors the following subsystems and processes. The
set of verifications performed for each assay varies based on the type of assay.
• Sample Metering
• Sample Dilution
• Reagent Metering
• Signal Reagent
• Well Wash
• Luminometer
D-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
APPENDIX D INTELLICHECK® TECHNOLOGY
NOTIFICATIONS FROM INTELLICHECK® TECHNOLOGY

When exceptions to Intellicheck® Technology verifications occur, results that may
be affected by these exceptions are prevented from being reported. The system
automatically performs an analysis, determines the next process forward, and
maintains continuous sample and assay processing. For example, if the system
detects a bubble in a sample, only the affected assay is noted with a code, no
result is reported, and processing continues for any samples in the Sample
Handling center.
For each detected exception, Intellicheck® Technology provides the following

notifications:
• A condition code that details the situation and provides prioritized corrective
action steps specific to the exception or condition.
• Codes and flags that are specific to subsystems and individual components
and are clearly displayed and reported. They are linked with the assay
results for on screen and printed patient, calibration, and Quality Control
result reports. These are transmitted to a laboratory computer (LIS).
• Automatic system initialization for many of these events, providing for

continued system operation.
• e-Connectivity®, a real-time, secure, two-way, interactive connection

between your system and Ortho Clinical Diagnostics that automatically
transfers system performance data to the OCD Customer Technical
Support Center for real-time analysis.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 D-3
INTELLICHECK® TECHNOLOGY APPENDIX D
RESULT INTELLICHECK®
Result Intellicheck®, a component of Intellicheck® Technology, reports real-
time status of every result, assures the integrity of every result, and serves
as an important record for the quality of results. This feature can be found on
the Results Review screen. Result Intellicheck® provides traceability for each
reported result. For every assay result, Result Intellicheck® displays the following
information:
• Verification of results
• Acceptable ranges
• Actual readings
• Exceptions to Intellicheck® Technology verifications
All exceptions are shown in red text on the screen. Note exception information
when contacting the OCD Customer Technical Support Center. This information
aids in troubleshooting system problems.
D-4 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
KEY OPERATOR TRAINING CHECKLIST
Key Operator Training

Checklist
MODULE 2: HARDWARE OVERVIEW
Identify and locate the main system components of the VITROS®
ECi/ECiQ System.
Specify the basic functionality of each component.
Specify the MicroWell™ sequence through the system.
MODULE 3: SOFTWARE OVERVIEW

Navigate through system screens using process buttons, mini-buttons,
or their corresponding function keys.
Calibrate the Touchscreen Monitor.
Print screens and cancel print requests.
Identify when a condition code occurs and access the Condition

Review screen.
Identify severity levels associated with condition codes.
View possible causes of codes and take appropriate action(s).
Use Intellicheck® Monitoring to review system verifications.
Review Environmental Monitoring to check subsystem status.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 KOT-1
MODULE 4: REAGENT MANAGEMENT

Identify information on a reagent pack bar code label.
Store and handle reagents.
Load and unload reagent packs.
Identify the main components of the Reagent Management screen.
Scan magnetic cards.
Display inventory on the system.
View expiration dates of reagents.
MODULE 5: DAILY MAINTENANCE

Locate the Periodic Maintenance screen and review the daily maintenance
procedures.
Perform the daily maintenance procedures specified.
KOT-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
MODULE 6: SAMPLE PROGRAMMING

Set up Universal Sample Trays.
Specify minimum fill requirements for sample containers.
Identify the main components of the Sample Programming screen.
Differentiate sample programming methods, and select those appropriate

for your laboratory.
Program assays and dilutions and enter patient demographics.
Edit and delete programming via the System Command Center.
View downloaded messages.
Create, edit, and delete panels.
Add tips to the Auxiliary Tip Supply.
View the status of samples in progress.
MODULE 7: PERIODIC MAINTENANCE

Locate the Periodic Maintenance screen and review the weekly, monthly,
Perform the weekly, monthly, and as-required maintenance procedures

specified.
MODULE 8: QUALITY CONTROL

Specify how to store and reconstitute Quality Control fluids.
Describe how to use the Package Insert Sheets.
Identify when to run Quality Control.
Configure QC software to monitor QC fluids.
Review QC data:
• Review graphs and result records.
• Add comments and omit QC points.
• Update baseline statistics.
Print QC graphs and reports.
MODULE 9: RESULTS REVIEW

Identify the main components of the Results Review screen.
Define search result criteria to display results in desired format.
Locate and interpret results.
Delete result records.
Release deferred reports.
Edit results and patient data.
Recalculate results after a failed calibration to avoid reprocessing.
Send results to a printer or Laboratory Information System (LIS) on demand

and cancel print requests.
Use Result Intellicheck® to view Intellicheck® verifications for samples and

assays.
Archive patient results to DOS-formatted diskette.
Retrieve and review archived results.
MODULE 10: CALIBRATION

Specify when to calibrate the system.
Identify how to store and handle calibrators.
Process calibrators with or without bar code labels.
Locate and review calibration detail.
Review and modify lot-specific calibration data.
Restore calibrations.
Assign primary status to calibrations.
Delete calibrations.
Differentiate between successful and unsuccessful calibration reports.
Identify how to enter a user calibration.
Recalculate results.
MODULE 11: SYSTEM CONFIGURATION AND

E-CONNECTIVITY®
Identify the configurable features of the system.
Locate additional detail about configurable system features using the OCD
reference documentation.
Configure analytes, reports, system processes, and e-Connectivity®.
Configure a system for automatic two-way data exchange and remote

connectivity.
MODULE 12: SYSTEM TROUBLESHOOTING

Discuss and observe normal operations of the subsystems.
Investigate possible causes of subsystem issues.
Describe how Intellicheck® Monitoring is used to generate verification data.
Identify the main components of the Diagnostics screen.
Specify when and how to use MEDs successfully.
Use MEDs to recreate the path of the well through the system.
Perform basic troubleshooting using MEDs.
The participant and instructor signatures that follow indicate the completion of
selected modules.
Participant: (Print Name)____________________________________________
Participant: (Signature)_____________________________________________
Date:_______________________________
Instructor: (Print Name)____________________________________________
Instructor: (Signature)______________________________________________
Date:_______________________________
ONSITE OPERATOR TRAINING CHECKLIST
Onsite Operator Training

Checklist
WELCOME
Identify the Onsite Operator Training course objectives.
HARDWARE OVERVIEW
Identify and locate the main system components of the VITROS®
ECi/ECiQ System.
Specify the basic functionality of each component.
Specify the MicroWell™ sequence through the system.
SOFTWARE OVERVIEW
Navigate through system screens using process buttons, mini-buttons, or
their corresponding function keys.
Identify when a condition code occurs and access the Condition Review
Screen
Identify severity levels associated with condition codes.
View possible causes of codes and take appropriate action(s).
Review Environmental Monitoring to check subsystem status.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 Site-1
REAGENT MANAGEMENT
Store and handle reagents.
Load and unload reagent packs.
Identify the main components of the Reagent Management screen.
Scan magnetic cards.
Display inventory on the system.
View expiration dates of reagents.
DAILY MAINTENANCE
Locate the Periodic Maintenance screen and review the daily maintenance
procedures.
Perform the daily maintenance procedures specified.
SAMPLE PROGRAMMING
Identify the main components of the Sample Programming screen.
Program assays and dilutions and enter patient demographics.
Edit and delete programming via the System Command Center.
Add tips to the Auxiliary Tip Supply.
View the status of samples in progress.
Site-2 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING
PERIODIC MAINTENANCE
Locate the Periodic Maintenance screen and review the weekly, monthly,
Perform the weekly, monthly, and as-required maintenance procedures

specified.
QUALITY CONTROL
Specify how to store and reconstitute Quality Control fluids.
Describe how to use the Package Insert Sheets.
Identify when to run Quality Control.
RESULTS REVIEW
Identify the main components of the Review Results screen.
Locate and interpret results.
Edit results.
Edit patient data.
Send results to a printer or Laboratory Information System (LIS) on demand

and cancel print requests.
SYSTEM TROUBLESHOOTING
Investigate possible causes of subsystem issues.
Specify when and how to use MEDs successfully.
Use MEDs to recreate the path of the well through the system.
Perform basic troubleshooting using MEDs.
VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 Site-3
The participant and instructor signatures that follow indicate the completion of
selected modules.
Participant: (Print Name)____________________________________________
Participant: (Signature)_____________________________________________
Date:_______________________________
Instructor: (Print Name)____________________________________________
Instructor: (Signature)______________________________________________
Date:_______________________________
Site-4 163 V2 EN 2009-04 VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING

ECi Key Operator Training - Instructor Guide

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

ECi Key Operator Training - Instructor Guide

Uploaded by

Copyright:

Available Formats

VITROS® ECi/ECiQ Immunodiagnostic System

Key Operator Training

Module 2: Hardware Overview

Module 3: Software Overview

Module 4: Reagent Management

Module 5: Daily Maintenance

Module 6: Sample Programming

Module 7: Periodic Maintenance

Module 8: Quality Control

Module 9: Results Review

Module 10: Calibration

Module 11: System Configuration and e-Connectivity®

Module 12: System Troubleshooting

Daily Reviews/Start-Up Exercises

Appendix A: MicroWell™ Technology

Appendix B: Immunoassay Calibration Theory

Appendix C: Diagnosing Codes

Appendix D: Intellicheck® Technology

VITROS® ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM KEY OPERATOR TRAINING 163 V2 EN 2009-04 1

Welcome participants in the

Introduce yourself, your

• Accommodations and location of restaurants

Review the administrative

Review the following COURSE OBJECTIVES

• Run the VITROS® ECi/ECiQ System in routine operations using the

• Handle, load, unload, and store reagents.

• Process patient and QC samples.

• Perform daily, weekly, monthly, and as required system maintenance.

• Program, run, and verify assay calibrations.

• Set various configuration options on the system.

• Use all VITROS® ECi/ECiQ System reference materials to perform basic

SKILL CHECKS (STUDENT EVALUATION)

• Knowledge Checks will be incorporated within certain modules.

• Ortho Clinical Diagnostics will keep a list of participants who have

EXPLANATION OF ICONS IN TRAINING GUIDE

The note icon indicates that supplemental information is included.

Review the classroom

• Identify and locate the main system components of the VITROS®

• Specify the basic functionality of each component.

• Specify the MicroWell™ sequence through the system.

Provide an overview of SYSTEM CENTERS AND SUBSYSTEMS

• Load and unload samples, reagents, and supplies.

• Perform sample and assay processing.

System Command Center

• Interact with touchscreen monitor.

• Scan magnetic cards.

• Print reports and screen displays.

• Send results and data to a laboratory computer.

• Power on system and reset system.

• View diagnostic status.

• Obtain system’s overall well count.

• Perform computer processing.

Show the Interlock switches.

Explain the Journey of

Point out the SR volume

Ask participant to complete EXERCISE: HARDWARE IDENTIFICATION

Auxiliary Tip Supply

Main Cover Interlock Switch

Exercise completed satisfactorily:_________________________________

Ask participants to complete

A. Sample Supply _____1. Aspirates and dispenses the sample

G. MicroWell™ Incubator _____7. Incubates wells and then moves

H. Reagent Metering Probe _____8. Holds MicroWell™ reagent packs.

• Navigate through system screens using process buttons, mini-buttons, or