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J33154_EN

Quick Guide
VITROS® ECiQ/ECi Immunodiagnostic Systems
2
2

IMPORTANT
The information contained herein is based on the experience and knowledge relating to the subject
matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.
No patent license is granted by the information.
Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without notice, and
makes no warranty, express or implied, with respect to the information. The company shall not be
liable for any loss or damage including consequential or special damages, resulting from the use of
this information, even if loss or damage is caused by its negligence or other fault.

VITROS is a trademark of Ortho-Clinical Diagnostics, Inc.

© 2004 Ortho-Clinical Diagnostics, Inc. All rights reserved.


VITROS ECi Immunodiagnostic Systems - Quick Guide Part Number 6C2832

READER EVALUATION QUESTIONNAIRE


Ortho-Clinical Diagnostics, Inc. is committed to providing quality documentation that our customers can use effectively. With
this goal in mind, we welcome your evaluation of this manual. Please help us by completing this questionnaire and returning it
to us by fax at 1-585-453-3729, or by mail in an envelope addressed to: Technical Communications,
MC 00885, Ortho-Clinical Diagnostics, Inc., 100 Indigo Creek Drive, Rochester, NY 14626-5101. Thank you!

Company Name: ________________________________________________________________________________


Address: _______________________________________________________________________________________
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Your Name: ______________________________________________ Job Title: ____________________________

r Please call me to discuss my comments


Please indicate the response closest to your opinion by checking one box for each statement.

STRONGLY
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1. The manual’s purpose is clearly stated in the preface or introduction. r r r r
2. Important topics are covered adequately in the text. r r r r
3. The information is technically accurate. r r r r
4. The information is organized in a logical sequence. r r r r
5. The writing suits my vocabulary and job-related needs. r r r r
6. Clear and relevant examples are used to illustrate the information. r r r r
7. Procedures needed to perform major tasks are clearly explained. r r r r
8. Artwork is clear and easily read. r r r r
9. After reading this manual, I was able to perform the operations
it describes. r r r r
10. This manual will help me do my job. r r r r
11. Terms are adequately defined. r r r r
12. Information is easy to locate. r r r r
13. The print and page layout are easy to read and use. r r r r
14. Do you use the online help function of your system? Yes r No r
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Reader Evaluation Questionnaire Version 2.0


Revision History

Revision Date Version Description


2004FEB 2.0 New release. Reflects software version 3.0.1 of the system.
Revision History and List of Revised Pages revised.
New or revised information since the last release is in the following
sections, indicated by change bars:

• Program and Process Samples (Chapter 4)


— Added Rept to program characteristics

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide v Version 2.0


Revision Date Version Description
2003NOV 1.0 The document format includes version numbering.
Incorporated Technical Bulletin J08969 - Update - Signal Reagent
Packs:
• Added a CAUTION statement regarding the loading of a signal
reagent pack
Updated Reader Evaluation Form
2/98 New release. Reflects software version 2.0 of the system.
Table of Contents and Alphabetical List of Procedures revised.
Revision History and List of Revised Pages revised.
New or revised information since the last release is in the following
sections, indicated by change bars:
• Program and Process Samples (Chapter 4)
— Defining sample programs
— Adding tips to the auxillary tip supply

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide vi Version 2.0


Revision Date Version Description
• Review Results (Chapter 5)
— Viewing samples in process
• Configure the System (Chapter 8)
— Configuring assay panels
— Configuring analyte data
6/97 New release. Reflects software version 1.5 of the system.
Table of Contents and Alphabetical List of Procedures revised.
Revision History and List of Revised Pages revised.
New or revised information since the last release is in the following
sections, indicated by change bars:
• Startup and Shutdown (Chapter 1)
— Viewing U.S. patent information
• Perform Calibration (Chapter 3)
— Loading and processing calibrators

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Revision Date Version Description
• Program and Process Samples (Chapter 4)
— Preparing samples
11/96 First release of document reflects software version 1.0 of the system.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide viii Version 2.0


List of Revised Pages
Each page in your guide should be at the date listed below:

Revision Date Version Chapter Page


2004FEB 2.0 All All
2003NOV 1.0 All All
2/98 All All
6/97 All All
11/96 All All

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide ix Version 2.0


VITROS ECi/ECiQ Immunodiagnostic System Quick Guide x Version 2.0
About This Guide
This guide contains abbreviated versions of frequently used procedures described in the
VITROS® ECi/ECiQ Immunodiagnostic System Operator’s Guide and Maintenance &
Diagnostics Guide. It is designed to refresh your memory on these procedures. For complete
information on these and all procedures, refer to the Operator’s Guide and Maintenance &
Diagnostics Guide.

The availability of the ECi/ECiQ Immunodiagnostic Assays listed and illustrated in this guide
are subject to regulatory registration, licensing, clearance, or approval.
How This Guide Is Organized
The table of contents lists major sections of each chapter. In addition, an alphabetical list of all
procedures is provided following the table of contents. This guide contains 8 chapters covering
system operating procedures.

Chapter 1: Startup and Shutdown. Basic startup and shutdown procedures.

Chapter 2: Load Reagents. Basic procedures for loading reagents.

Chapter 3: Perform Calibration. Basic procedures for performing calibration and reviewing
calibrations.

Chapter 4: Program and Process Samples. Basic procedures for programming and processing
patient samples.

Chapter 5: Review Results. Basic procedures for reviewing and editing results, and managing
reports.

Chapter 6: Perform Quality Control. Basic procedures for performing quality control.

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Chapter 7: Back Up Data. Basic procedures to back up data to diskettes.

Chapter 8: Configure the System. Basic procedures to customize your system with frequently
used configurable features.

Conventions Used in This Guide


Information is provided in a standard format throughout this guide to make the guide easy to use.
The following conventions are used in notices, terms, and procedures:

Notices
Note: To emphasize or clarify information or instructions.
IMPORTANT: To emphasize or clarify information requiring greater emphasis than a Note.
CAUTION: To prevent damage to or from equipment.
WARNING: To prevent actions that can cause personal injury.
DANGER: TO INFORM YOU THAT A PERIL TO HEALTH AND SAFETY EXISTS.

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Terms
Throughout this guide, the following terms are used to distinguish touchscreen and keyboard
actions:
• Touch is used when you are directed to use a screen button or field by touching it with a finger
or the eraser end of a pencil. Button names in text appear in bold as follows:
Touch Save to save your changes.
• Press is used when you are directed to use a key on the keyboard. Keyboard keys mentioned in
text appear in bold as follows:
Press Enter to move to the next field.

Procedures
Procedures are introduced by bold headings followed by numbered steps. The end of a procedure
is indicated by a double line under the last step.

When you are directed to press Enter, you can press any of the Enter, Tab, or Return keys on
the keyboard and achieve the same effect.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide xiv Version 2.0


When you are directed to touch an item that has a check box or radio button in front of it, you
can touch either the check box or the radio button, or the related text.

When you are directed to type a date or time, use the format defined on the Options &
Configuration - Configure System screen. For the year, always type the four digits.

When a step contains a directive to touch a button or type information in a field, a representative
graphic is shown to the left of the step. Availability of assays represented in graphics is subject
to regulatory clearance or approval.

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Contents
1 Startup and Shutdown
Start Up the System ............................................................................................................. 1-2
Start Up the System .......................................................................................................... 1-2
Shut Down the System ......................................................................................................... 1-5
Perform Normal Shut Down............................................................................................. 1-5
Perform Emergency Shut Down and Restart the System ................................................. 1-7

2 Load Reagents
Load Assay Reagent Packs.................................................................................................. 2-2
Load Reagent Packs Automatically.................................................................................. 2-2
Load Reagent Packs with the Unload/Load Button.......................................................... 2-3
Enter Bar Code Information for a Reagent Pack .............................................................. 2-5
Load Signal Reagent (SR) Packs ........................................................................................ 2-6
Load SR Packs Automatically .......................................................................................... 2-6
Load SR Packs with the Exchange SR Button ................................................................. 2-8
Load Universal Wash Reagent............................................................................................ 2-11
3 Perform Calibration
Scan Protocol and Reagent Lot Calibration Mag Cards ................................................. 3-2
Load and Process Calibrators............................................................................................. 3-3
Review Calibrations............................................................................................................. 3-6
Review Calibration Details............................................................................................... 3-8
View Calibration Parameters ............................................................................................ 3-8
Restore a Calibration to Current Status ............................................................................ 3-9
Make a Calibration Primary ............................................................................................. 3-9

4 Program and Process Samples


Define Sample Programs..................................................................................................... 4-2
Program by Sample ID ..................................................................................................... 4-2
Program by Tray ID.......................................................................................................... 4-4
Program by Batch ............................................................................................................. 4-6
Edit Patient Data and Select Report Status for a Program .......................................... 4-8
Review Sample Programs................................................................................................. 4-11
Prepare Samples................................................................................................................... 4-14
Add Tips to the Auxiliary Tip Supply................................................................................ 4-15

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Process Samples ................................................................................................................... 4-16
Unload Samples.................................................................................................................... 4-18
Unload Samples from Non-Metering Positions................................................................ 4-18
Unload Samples at the Metering Position ........................................................................ 4-18

5 Review Results
Review and Edit Result Records ........................................................................................ 5-2
Search for Result Records ................................................................................................ 5-2
Review or Edit Result Records......................................................................................... 5-5
Edit Patient Data and Report Statuses .............................................................................. 5-7
Delete Result Records ...................................................................................................... 5-9
Recalculate Results........................................................................................................... 5-10
View Samples in Process...................................................................................................... 5-11
Manage Reports ................................................................................................................... 5-13
Change Report Statuses .................................................................................................... 5-13
Change Report Statuses for Records Matching General Search Criteria .................... 5-13
Change Report Statuses for Selected Records............................................................. 5-14
Change Report Statuses and Edit Patient Data for One Record.................................. 5-15
Release Deferred Reports ................................................................................................. 5-17

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6 Perform Quality Control
Review or Define Control Fluids ........................................................................................ 6-2
Review Control Fluids...................................................................................................... 6-2
Define or Edit Control Fluids ........................................................................................... 6-4
Delete Control Fluids........................................................................................................ 6-7
Review and Edit QC Results............................................................................................... 6-9
Review Results by Analyte............................................................................................... 6-9
Omit or Include Results in Statistical Calculation ...................................................... 6-11
Edit or Add Comments to a Result Record ................................................................. 6-12
Edit Baseline Statistics for an Analyte ........................................................................ 6-13
Review Results by Control ............................................................................................... 6-15
Omit or Include Results in Statistical Calculation ...................................................... 6-16
Edit or Add Comments to a Result Record ................................................................. 6-18
Graph or Print QC Results ................................................................................................. 6-19
Graph Results or Print Reports by Analyte ...................................................................... 6-19
Graph Results by Analyte............................................................................................ 6-20
Print Reports by Analyte ............................................................................................. 6-24
Print Reports by Control................................................................................................... 6-26
Graph Results or Print Reports by Interval ...................................................................... 6-28
Display or Print Graphs by Interval ............................................................................ 6-31
Print Reports by Interval ............................................................................................. 6-33
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7 Back Up Data
Make Backup Diskettes ....................................................................................................... 7-2
Make Backup Diskettes Using the Options & Configuration Screen .............................. 7-2

8 Configure the System


Configure Assay Panels ....................................................................................................... 8-2
Define Panels .................................................................................................................... 8-2
Edit Panels ........................................................................................................................ 8-5
Delete Panels .................................................................................................................... 8-7
Configure Analyte Data....................................................................................................... 8-9
Configure Units ................................................................................................................ 8-9
Configure Reference Ranges ............................................................................................ 8-11
Configure Supplementary Ranges .................................................................................... 8-13
Configure System Settings .................................................................................................. 8-15
Set System Sounds and Screensaver ................................................................................ 8-15
Set the Date and Time....................................................................................................... 8-17
Enter the System Name or ID........................................................................................... 8-19

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Configure Report Destination, Printing, and Transmission ............................................ 8-21
Designate Destination Printers ......................................................................................... 8-21
Select Destination Printers for Each Report Type ............................................................ 8-23
Specify Report Status Defaults......................................................................................... 8-24
Set Report Transmission................................................................................................... 8-25
Enable Requests from Your Laboratory Computer .......................................................... 8-26

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Alphabetical List of Procedures
Add Tips to the Auxiliary Tip Supply.................................................................................... 4-15
Change Report Statuses and Edit Patient Data for One Record ............................................ 5-15
Change Report Statuses for Records Matching General Search Criteria .............................. 5-13
Change Report Statuses for Selected Records ....................................................................... 5-14
Change Report Statuses ......................................................................................................... 5-13
Configure Analyte Data ......................................................................................................... 8-9
Configure Assay Panels ......................................................................................................... 8-2
Configure Reference Ranges ................................................................................................. 8-11
Configure Report Destination, Printing, and Transmission................................................... 8-21
Configure Supplementary Ranges ......................................................................................... 8-13
Configure System Settings..................................................................................................... 8-15
Configure Units...................................................................................................................... 8-9
Define or Edit Control Fluids ................................................................................................ 6-4
Define Panels ......................................................................................................................... 8-2
Define Sample Programs ....................................................................................................... 4-2
Delete Control Fluids............................................................................................................. 6-7
Delete Panels.......................................................................................................................... 8-7
Delete Result Records............................................................................................................ 5-9
Designate Destination Printers............................................................................................... 8-21
Display or Print Graphs by Interval ....................................................................................... 6-31
Edit Baseline Statistics for an Analyte................................................................................... 6-13
Edit or Add Comments to a Result Record............................................................................ 6-12
Edit or Add Comments to a Result Record............................................................................ 6-18
Edit Panels ............................................................................................................................. 8-5
Edit Patient Data and Report Statuses ................................................................................... 5-7
Edit Patient Data and Select Report Status for a Program..................................................... 4-8
Enable Requests from Your Laboratory Computer................................................................ 8-26
Enter Bar Code Information for a Reagent Pack ................................................................... 2-5
Enter the System Name or ID ................................................................................................ 8-19
Graph or Print QC Results ..................................................................................................... 6-19
Graph Results by Analyte ...................................................................................................... 6-20
Graph Results or Print Reports by Analyte ........................................................................... 6-19
Graph Results or Print Reports by Interval............................................................................ 6-28
Load and Process Calibrators ................................................................................................ 3-3
Load Assay Reagent Packs .................................................................................................... 2-2
Load Reagent Packs Automatically ....................................................................................... 2-2
Load Reagent Packs with the Unload/Load Button............................................................... 2-3
Load Signal Reagent (SR) Packs ........................................................................................... 2-6
VITROS ECi/ECiQ Immunodiagnostic System Quick Guide xxvi Version 2.0
Load SR Packs Automatically ............................................................................................... 2-6
Load SR Packs with the Exchange SR Button ...................................................................... 2-8
Load Universal Wash Reagent............................................................................................... 2-11
Make a Calibration Primary................................................................................................... 3-9
Make Backup Diskettes Using the Options & Configuration Screen.................................... 7-2
Make Backup Diskettes ......................................................................................................... 7-2
Manage Reports ..................................................................................................................... 5-13
Omit or Include Results in Statistical Calculation................................................................. 6-11
Omit or Include Results in Statistical Calculation................................................................. 6-16
Perform Emergency Shut Down and Restart the System ...................................................... 1-7
Perform Normal Shut Down .................................................................................................. 1-5
Prepare Samples..................................................................................................................... 4-14
Print Reports by Analyte........................................................................................................ 6-24
Print Reports by Control ........................................................................................................ 6-26
Print Reports by Interval........................................................................................................ 6-33
Process Samples..................................................................................................................... 4-16
Program by Batch .................................................................................................................. 4-6
Program by Sample ID .......................................................................................................... 4-2
Program by Tray ID ............................................................................................................... 4-4
Recalculate Results ................................................................................................................ 5-10
Release Deferred Reports ...................................................................................................... 5-17
VITROS ECi/ECiQ Immunodiagnostic System Quick Guide xxvii Version 2.0
Restore a Calibration to Current Status ................................................................................. 3-9
Review and Edit QC Results ................................................................................................. 6-9
Review and Edit Result Records ........................................................................................... 5-2
Review Calibration Details .................................................................................................... 3-8
Review Calibrations............................................................................................................... 3-6
Review Control Fluids ........................................................................................................... 6-2
Review or Define Control Fluids........................................................................................... 6-2
Review or Edit Result Records .............................................................................................. 5-5
Review Results by Analyte.................................................................................................... 6-9
Review Results by Control .................................................................................................... 6-15
Review Sample Programs ...................................................................................................... 4-11
Scan Protocol and Reagent Lot Calibration Mag Cards ........................................................ 3-2
Search for Result Records...................................................................................................... 5-2
Select Destination Printers for Each Report Type ................................................................. 8-23
Set Report Transmission ........................................................................................................ 8-25
Set System Sounds and Screensaver...................................................................................... 8-15
Set the Date and Time............................................................................................................ 8-17
Shut Down the System........................................................................................................... 1-5
Specify Report Status Defaults .............................................................................................. 8-24
Start Up the System ............................................................................................................... 1-2
Start Up the System ............................................................................................................... 1-2
VITROS ECi/ECiQ Immunodiagnostic System Quick Guide xxviii Version 2.0
Unload Samples at the Metering Position.............................................................................. 4-18
Unload Samples from Non-Metering Positions..................................................................... 4-18
Unload Samples ..................................................................................................................... 4-18
View Calibration Parameters ................................................................................................. 3-8
View Samples in Process ....................................................................................................... 5-11

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1
Startup and Shutdown

This chapter describes the steps and procedures to prepare the system for operation or shutdown.
For complete information and procedures on starting up or shutting down the system, refer to
Chapter 3, “Starting Up and Shutting Down,” in the Operator’s Guide.
Start Up the System

Start Up the System


1. Power on the printer.
2. Verify that the system’s electrical cable is securely plugged into the power
outlet.
3. Move the system’s main power switch to the On position.
4. When the Copyright screen is displayed, do one of the following:
ed
States o f A View the Patents dialog box by touching View U.S. Patents within 10
me
it

seconds.
Un

r ica

or
Cancel the startup process by touching Final Shutdown within 10 seconds.

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or
Display the System Menu by touching System Menu within 10 seconds. (You
can load new software, perform backups and other disk-related functions, and
configure language using the System Menu screen.)
or
Allow the startup process to complete. When the Main Menu is displayed, go
to step 5.
5. Verify the status of reporting devices:
a. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ b. Type your access code, then touch OK (or press Enter or touch OK
without typing your access code).
OK

c. Touch Configure Report Control.

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On Of f
d. Verify that On is selected for printers (Printer 1 or Printer 2) to be used.

Of f Send Defer e. Verify that the appropriate report status (Off, Send, or Defer) is selected
for each report type.

1 2
f. Verify that the appropriate destination printer (1 or 2) is selected for each
report type.

Yes No
g. Verify that the appropriate selection (Yes or No) is made to transmit each
report type.

Yes No
h. Verify that the appropriate selection (Yes or No) is made to receive
requests from the laboratory computer.
i. Touch Return/Save to save any changes and return to the Options &
Configuration screen.

j. Touch Return to return to the Main Menu screen.

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Shut Down the System

Perform Normal Shut Down


1. Ensure that:
• No sample metering is taking place.
• No wells are processing in the incubator.
• If the system will be shut down for an extended period of time, all reagents
(assay reagent packs, signal reagent packs, and universal wash reagent) are
unloaded.
2. If any conditions are reported on the status console, touch the Condition
Review button and perform the recommended actions to resolve all reported
conditions.
3. Touch Return until the Main Menu screen is displayed.

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4. Touch Shutdown to display the Shutdown dialog box.

Yes 5. Touch Yes.

or

Shutdown Touch Shutdown to cancel sample and assay processing.

6. Optional: Perform a complete shutdown:


a. Touch Final Shutdown on the Copyright screen.

Yes b. Touch Yes.

c. When final shutdown is complete, move the main power switch to the Off
position.
7. Power off the printer.

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Perform Emergency Shut Down and Restart the System
1. Move the main power switch to the Off position.
2. Wait 10 seconds.
3. Follow the steps in “Start Up the System” on page 1-2.

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2
Load Reagents

This chapter describes the basic procedures to load assay reagent, signal reagent, and universal
wash reagent. For complete information and procedures on loading reagents and supplies, refer
to Chapter 4, “Managing Reagents and Supplies,” in the Operator’s Guide.
WARNING: Dispose of all solid and liquid waste according to local regulations and
laboratory procedures.
Load Assay Reagent Packs

Load Reagent Packs Automatically


1. Ensure that the LED near the auto-load station is green.
2. Open the outer load door.
3. Place the reagent pack in the auto-load station.
4. Repeat steps 1 through 3 for each additional pack you want to load.
5. Close the outer load door.
6. Perform calibration if this is a new assay reagent lot number. (Refer to
Chapter 5, “Performing Calibration,” in the Operator’s Guide for
instructions.)

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Load Reagent Packs with the Unload/Load Button
1. Touch Reagent Management on the Main Menu screen (or its mini-button).

2. Touch Unload/Load.

3. Remove and discard any empty packs as they move out of the reagent supply
door.
4. Ensure that the LED display near the auto-load station is green.
5. Open the outer load door.
6. Place the pack in the auto-load station.
7. Close the outer load door.
8. Repeat steps 4 through 7 for each additional pack you want to load.

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OK 9. Touch OK.

10. If this is a new reagent lot number, perform calibration. (Refer to Chapter 5,
“Performing Calibration,” in the Operator’s Guide for instructions.)

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Enter Bar Code Information for a Reagent Pack
1. Load the pack without a bar code.
2. Touch Reagent Management on the Main Menu screen (or its mini-button).

Bar Code? 3. Touch the Bar Code? pack button.

Barcode: __________ 4. Type the bar code number, then press Enter.

OK 5. Touch OK.

6. If the dialog box reflects the correct number, touch Yes (or touch No and type
Yes the correct number).

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Load Signal Reagent (SR) Packs

Load SR Packs Automatically


1. Open the signal reagent load door.
2. Place a new SR pack in the load position on the signal reagent carousel.
CAUTION: Do not reload a used SR pack. Verify that SR packs are new and
have never been used before loading them onto the system. (An
SR pack can only be unloaded and stored for future use if it has
never been used, pierced, or placed in the in-use position on the
SR carousel.)
CAUTION: Do not move or reposition SR packs after they have been loaded
onto the system.
3. Close the signal reagent load door.
4. Edit the expiration date for the newly loaded pack:

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a. Touch Reagent Management on the Main Menu screen (or its mini-
button).

b. Touch View Supplies.

c. Touch Edit SR Expiration.

Days Until Expired: __ d. Type the number of days until the load-position pack expires, then press
Enter.
or
Expiration Date: __________ Type the expiration date of the load-position pack, then press Enter.

OK e. Touch OK.

f. Touch Return.

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Load SR Packs with the Exchange SR Button
1. Open the signal reagent load door.
2. Remove the old pack from the load position and replace it with a new pack.
3. Touch Reagent Management on the Main Menu screen (or its mini-button).

4. Touch View Supplies.

5. Touch Exchange SR.

Yes 6. Touch Yes.

7. Remove the used pack from the load position.

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8. Place a new pack in the load position.
CAUTION: Do not reload a used SR pack. Verify that SR packs are new and
have never been used before loading them onto the system. (An
SR pack can only be unloaded and stored for future use if it has
never been used, pierced, or placed in the in-use position on the
SR carousel.)
CAUTION: Do not move or reposition SR packs after they have been loaded
onto the system.
9. Close the signal reagent load door.
10. Edit the expiration date for both packs:
a. Touch Edit SR Expiration.

Days Until Expired: __ b. Type the number of days until each pack expires, then press Enter.

or
Expiration Date: __________ Type the expiration date of each pack, then press Enter.

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OK c. Touch OK.

d. Touch Return.

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Load Universal Wash Reagent
1. Open both front doors of the system.
2. Move the upper toggle (pressure) switch to the Off position.
3. Pull out the liquid supply tray.
4. Disconnect the tubes from the universal wash reagent bottle cap.
5. Remove the universal wash reagent bottle from the tray and remove the cap.
6. Place the cap on the new bottle and place the bottle in position on the liquid
supply tray.
7. Connect the appropriate tubes to the appropriate connectors on the cap.
8. Push the tray back into the cabinet.
9. Move the upper toggle (pressure) switch to the On position.
10. Close both front doors.

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3
Perform Calibration

This chapter describes the basic procedures to calibrate assay reagent lots. To perform
calibration, you will use a calibration package—which includes Protocol cards, Reagent Lot
Calibration cards, and calibrators—specific to the assay and the lot number of an assay. For
complete information and procedures on calibration, refer to Chapter 5, “Performing
Calibration,” in the Operator’s Guide. For complete information and procedures on reviewing
and configuring calibrations, refer to Chapter 11, “Configuring & Customizing Your System,”
in the Operator’s Guide.
IMPORTANT: If this is the first time you are performing calibration on the system, read
Chapter 5, “Performing Calibration,” in the Operator’s Guide before
continuing with this procedure.
Scan Protocol and Reagent Lot Calibration Mag Cards
1. Ensure that the magnetic card scanner LED display is green.
2. Scan the first stripe of the mag card through the magnetic card scanner.
3. When the LED displays a blinking green light, scan the second stripe of the
mag card within 10 seconds.
Note: If one of the stripes fails to read, rescan both stripes.
4. If the LED displays a blinking green light again, another card needs to be
scanned; scan both stripes of the next card. Scan the second stripe within 10
seconds of the blinking green light.
5. Repeat steps 1 through 4 for additional mag cards.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-2 Version 2.0


Load and Process Calibrators
1. Ensure that the Protocol and Reagent Lot Calibration cards have been
scanned. (Refer to “Scan Protocol and Reagent Lot Calibration Mag Cards”
on page 3-2.)
2. Ensure that the reagent pack for the assay lot to be calibrated is loaded.
3. Allow the calibrators to reach room temperature, or reconstitute lyophilized
calibrators if necessary. Refer to the package inserts for information.
4. Place bar coded calibrators onto any universal sample tray, in any position on
the tray, with the bar code label facing through the slot.
or
If the tubes are not bar coded, use the Sample Programming screen to define a
calibration ID and select a tray and tray position:
a. Touch Sample Programming on the Main Menu screen (or its mini-
button).

Patient Control Cal b. Touch Cal for the sample type.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-3 Version 2.0


Sample ID: _______ c. Type the calibration ID (1–8 alphanumeric characters) in the Sample ID
field, then press Enter.
__ d. Touch Tray, type a tray ID (1–2 alphanumeric characters), then press
Tray
Enter. To select a different tray position, touch another position.

STAT e. If you want to give the program immediate priority, touch STAT.

Perm f. If you want to save the program permanently, touch Perm.

g. Touch Save/Next.

h. Repeat steps c through g to program additional calibrators.


i. Place the calibrator tubes into the designated tray.
j. Ensure that a disposable sample tip is present in the universal sample tray
for each calibrator to be processed.
5. Load the tray onto the sample tray conveyor.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-4 Version 2.0


6. Touch Sample Processing on the status console.

7. Review the calibration report to ensure that the calibration was successful.
8. After calibration is complete, perform quality control procedures.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-5 Version 2.0


Review Calibrations
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK (or if the function does
not require an access code, press Enter or touch OK without typing your
OK
access code).
3. Touch Review/User Calibrations.

4. Select the body fluid and the analyte.


Serum Plasma Urine

TSH TT4 T3U

B-hCG E2 Prog
5. Touch Review Calibrations.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-6 Version 2.0


6. Touch a calibration.

7. Follow steps in the appropriate section below to review calibration details,


view calibration parameters, restore a calibration to current status, or make a
calibration primary.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-7 Version 2.0


Review Calibration Details
1. Follow steps 1–6 in “Review Calibrations” on page 3-6.
2. Touch Review Cal Detail.

View Calibration Parameters


1. Follow steps 1–6 in “Review Calibrations” on page 3-6.
2. Touch Review Cal Detail.

3. Touch View Cal Parameters.

OK 4. Review information displayed, then touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-8 Version 2.0


Restore a Calibration to Current Status
1. Follow steps 1–6 in “Review Calibrations” on page 3-6.
2. Touch Restore Cal (or touch Review Cal Detail, then touch Restore Cal).

Make a Calibration Primary


1. Follow steps 1–6 in “Review Calibrations” on page 3-6.
2. Touch Make Primary (or touch Review Cal Detail, then touch Make
Primary).

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-9 Version 2.0


VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 3-10 Version 2.0
4
Program and Process Samples

This chapter describes the basic procedures to program, prepare, and process patient samples.
For complete information and procedures on working with patient samples, refer to Chapter 6,
“Preparing Samples” and Chapter 7, “Programming Samples” in the Operator’s Guide.
Define Sample Programs

Program by Sample ID
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

Sample ID: ______________ 2. Type the sample ID (1–15 alphanumeric characters), then press Enter.

3. Touch a body fluid.


Serum Plasma Urine

Inpat Outpat ER 4. Touch a patient type category.

to L/F FT4I FT 5. Touch the assays or panels to process for the sample.
1 Pan 2 Pan 3

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-2 Version 2.0


6. Optional: Touch the program characteristics you want (Patient Type
STAT Perm Rept Category, STAT, Perm, Rept, Special, +R/-R, Manual Dil, Assay Dil).

Special

Manual Dil Assay Dil +R -R

7. Optional: Touch Edit Pat Data to edit or add patient demographic


information, report status, or sample ID. Refer to “Edit Patient Data and
Select Report Status for a Program” on page 4-8.

8. Touch Save/Next.

9. Repeat this procedure to program additional samples.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-3 Version 2.0


Program by Tray ID
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

Tray 2. Touch Tray, type a tray ID (1–2 alphanumeric characters), then press Enter.
To select a different tray position, touch another position.
Sample ID: ______________ 3. Optional: Type a sample ID (1–15 alphanumeric characters), then press Enter.

4. Touch the body fluid.


Serum Plasma Urine

Inpat Outpat ER 5. Touch a patient type category.

to L/F FT4I FT 6. Touch the assays or panels to process for the sample.

Pan 2 Pan 3 Pan 4

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-4 Version 2.0


7. Optional: Touch the program characteristics you want (Patient Type
STAT Perm Rept
Category, STAT, Perm, Rept, Special, +R/-R, Manual Dil, Assay Dil).
Special

Manual Dil Assay Dil +R -R

8. Optional: Touch Edit Pat Data to edit or add patient demographic


information, report status, or sample ID. Refer to “Edit Patient Data and
Select Report Status for a Program” on page 4-8.
9. Touch Save/Next.

10. Repeat steps 3 through 9 to program additional samples for the tray.
11. Touch the Sample Programming mini-button to clear the Sample
Programming screen.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-5 Version 2.0


Program by Batch
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

2. Touch the body fluid.


Serum Plasma Urine

Inpat Outpat ER 3. Touch a patient type category.

to L/F FT4I FT 4. Touch the assays or panels to process for the samples.

Pan 2 Pan 3 Pan 4

STAT Perm Rept 5. Optional: Touch the program characteristics you want (Patient Type
Category, STAT, Perm, Rept, Special, +R/-R, Manual Dil, Assay Dil).
Special

Manual Dil Assay Dil +R -R

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-6 Version 2.0


6. Optional: Touch Edit Pat Data to edit or add patient demographic
information, report status, or sample ID. Refer to “Edit Patient Data and
Select Report Status for a Program” on page 4-8.
7. Touch Batch Save.

8. Assign the programs in the batch to the tray:

Tray __ a. Touch Tray, type a tray ID (1–2 alphanumeric characters), then press
Enter.
b. Touch any tray position you want to exclude from the batch program.
1. ______________ c. Optional: Type a sample ID (1–15 alphanumeric characters), then press
Enter.
or
1. ______________ Define sample IDs for the programs in the batch: Type a sample ID (1–15
alphanumeric characters), then press Enter. Repeat for each sample ID.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-7 Version 2.0


Save 9. Touch Save, then repeat step 8 to define additional trays or sample IDs.

or

OK Touch OK.

10. Touch Return.

Edit Patient Data and Select Report Status for a Program


1. Touch Edit Pat Data on the Sample Programming screen.

Sample ID: ______________ 2. Type or edit the sample ID (1–15 alphanumeric characters), then press Enter.

Cup: ___ 3. Type or edit the cup (tray position), then press Enter.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-8 Version 2.0


ID: _______________ 4. Type or edit patient information fields (1–15 alphanumeric characters for ID;
Last Name: _________________ 1–20 alphanumeric characters for last name; 1–15 alphanumeric characters
First Name: _______________
for first name; 1 alphanumeric character for middle initial; 1–20 characters
for each address line, date of birth, and age of patient; 1 alphanumeric
character for range attribute; 1 alphanumeric character for sex; 1–5
alphanumeric characters for room, collection date for the sample, and time
that the sample was collected), pressing Enter after each field.
ID: _______________ 5. Type or edit physician information fields (1–15 alphanumeric characters for
Last Name: _________________ ID, 1–20 alphanumeric characters for last name, 1–15 alphanumeric
First Name: _______________
characters for first name, 1 alphanumeric character for middle initial, 1–20
alphanumeric characters for each address line), pressing Enter after each
field.
Comments: _________________ 6. Type notes in the comments field (1–20 alphanumeric characters per line),
First Name: _________________ pressing Enter after each line.
First Name: _________________

7. Optional: Edit the report status:


a. Touch Set Report Status.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-9 Version 2.0


Of f Send Defer b. Touch Off, Send, or Defer for each report type.

OK c. Touch OK.

8. Touch Save/Next.

9. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-10 Version 2.0


Review Sample Programs
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

2. Touch Options.
1 2 3

3. Review Tray IDs:


a. Touch Review Tray IDs.

b. Touch Update List.

c. Review the displayed Tray IDs. (Refer to the Operator’s Guide for
information on deleting programs using the Review Tray IDs screen.)
or

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-11 Version 2.0


Review Sample IDs:
a. Touch Review Sample IDs. If desired, limit your search: type the Sample
ID or Tray ID and press Enter.

b. Touch Update List.

c. Touch Sample ID/Alpha or Sample ID/Time.

d. Optional: Touch Set Filter, define additional search criteria, then touch
OK.

OK

or
Touch Reset Filter to reset search criteria to the default and update the
screen.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-12 Version 2.0


e. Review the displayed Sample IDs. (Refer to the Operator’s Guide for
information on deleting programs using the Review Sample IDs screen.)
4. Touch Return until the Sample Programming screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-13 Version 2.0


Prepare Samples
1. Inspect the fill level of each collection tube. Pipette sample fluid into cups if
necessary, then securely place a pierceable cap on each cup (ensure that fluid
is not in contact with the underside of the cap). Place sample cups so they fit
loosely in 16 mm tubes; and micro-collection containers so they sit firmly in
the micro-collection container adapters.
2. If you are using micro-collection containers with attached caps, place the cap
in the groove on the left side of the micro-collection container adapter.
3. Insert tubes, including those with cups, or micro-collection container adapters
when necessary, into the sample tray. Ensure that bar code labels are visible.
4. Place the disposable tips into the tip positions on the sample tray.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-14 Version 2.0


Add Tips to the Auxiliary Tip Supply
1. Touch Sample Programming on the The Main Menu screen (or its mini-
button).

2. Touch Options.
1 2 3

3. Touch Rotate Aux Tip Supply to start the rotation cycle.

4. Insert disposable tips during the rotation cycle.


5. Repeat step 3 and 4 until all tips are inserted.
6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-15 Version 2.0


Process Samples
1. Remove the sample supply cover from the sample supply subsystem.
2. Place the sample containers into a tray.
3. Load the sample trays onto the sample tray conveyor.
4. Optional: Replace the sample supply cover.
5. If you programmed by sample ID and are not using bar code labels on sample
containers, assign the samples to a tray:
a. Touch Sample Programming on the Main Menu screen (or its mini-
button).

Tray __ b. Touch Tray, type a tray ID (1–2 alphanumeric characters), then press
Enter. To select a different tray position, touch another position.
Sample ID: ______________ c. Type a sample ID (1–15 alphanumeric characters), then press Enter.

d. Touch Save/Next.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-16 Version 2.0


e. Repeat steps c through d to program additional samples for the tray.

f. Touch the Sample Programming mini-button to clear the Sample


Programming screen.
or
Go to step 6.
6. If you loaded STAT samples, touch STAT Processing on the status console
S and sample metering will begin.

or
Go to step 7.
7. Touch Sample Processing on the status console.
Note: Touch Sample Processing again to stop sample metering.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-17 Version 2.0


Unload Samples

Unload Samples from Non-Metering Positions


1. Remove the sample supply cover from the sample supply subsystem.
2. Lift the tray from the sample tray conveyor or remove samples from the tray.
3. Replace the sample supply cover.

Unload Samples at the Metering Position


1. When sample metering and processing is complete, open the sample metering
safety shield.
2. Remove or replace samples in the tray.
3. Close the sample metering safety shield.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 4-18 Version 2.0


5
Review Results

This chapter describes the basic procedures to review and edit result records. For complete
information and procedures on evaluating and editing result records for patient and control
samples, refer to Chapter 8, “Reviewing Results,” in the Operator’s Guide.
Review and Edit Result Records

Search for Result Records


1. Touch Results Review on the Main Menu screen (or its mini-button).

2. Touch Search/Review/Edit.

ID: _______________ 3. Type patient or physician search criteria, then press Enter.
Last Name: _________________
First Name: _______________

Patient Control All 4. Touch Patient, Control, or All for the sample type.

: STAT Routine
5. Touch STAT, Routine, or All for the priority.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-2 Version 2.0


All Results: (Dates are cont 6. Touch All Results.

or
Adjustable date range Touch Adjustable date range; then type a start and end date and time, or
touch Last 24 Hours, or touch All Dates.
7. Touch Set Report Search Criteria, then define search criteria for each type of
report:

Yes No
a. Touch Yes or No for each report type criteria.

or

All 'Yes' Touch All “Yes”.

or

All 'No' Touch All “No”.

OK b. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-3 Version 2.0


8. Touch Search to view the number of records matching the criteria.

or
Touch Review/Edit to view or edit records matching the criteria; then follow
steps for the function desired in the appropriate section following.

or
Touch Set Report Status to change report status for reports matching the
criteria; then follow steps in “Change Report Statuses” on page 5-13.

or
Touch Release Deferred to release deferred reports matching the criteria; then
follow steps in “Release Deferred Reports” on page 5-17.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-4 Version 2.0


Review or Edit Result Records
1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Review result records displayed.


or
Edit results displayed:
a. Touch the result record to edit.

b. Touch Edit/Add Analytes.

c. Touch the result field to edit, type a result, then press Enter.
d. Repeat step c to edit additional results.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-5 Version 2.0


or
Add analyte results to the result record:
a. Touch the result record to edit.

b. Touch Edit/Add Analytes.

c. Touch Add Online Analytes.

T3U FT4 FT3


d. Touch analytes to add to the result record.

Prog FSH LH

OK e. Touch OK.

f. Type results for each added analyte, then press Enter.


4. Touch Return/Save.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-6 Version 2.0


Edit Patient Data and Report Statuses
1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Touch the result record to edit.

4. Touch Edit Pat Data.

ID: _______________ 5. Type or edit patient information fields (1–15 alphanumeric characters for ID,
Last Name: _________________ 1–20 alphanumeric characters for last name, 1–15 alphanumeric characters
First Name: _______________
for first name, 1 alphanumeric character for middle initial, 1–20 characters for
each address line, date of birth, age of patient, 1 alphanumeric character for
range attribute, 1 alphanumeric character for sex, 1–5 alphanumeric
characters for room, collection date for the sample, time that the sample was
collected), pressing Enter after each field.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-7 Version 2.0


ID: _______________ 6. Type or edit physician information fields (1–15 alphanumeric characters for
Last Name: _________________ ID, 1–20 alphanumeric characters for last name, 1–15 alphanumeric
First Name: _______________
characters for first name, 1 alphanumeric character for middle initial, 1–20
alphanumeric characters for each address line), pressing Enter after each
field.
Comments: _________________ 7. Type notes in the comments field (1–20 alphanumeric characters per line),
First Name: _________________ pressing Enter after each line.
First Name: _________________

8. Optional: Edit the report status for the record:


a. Touch Set Report Status.

Of f Send Defer b. Touch Off, Send, or Defer for each report type.

OK c. Touch OK.

9. Touch Return/Save.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-8 Version 2.0


Delete Result Records
1. Search for result records to delete that match your criteria. (Refer to “Search
for Result Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Touch the result records to delete.

4. Touch Delete Records.

Yes 5. Touch Yes.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-9 Version 2.0


Recalculate Results
1. Search for result records to recalculate that match your criteria. (Refer to
“Search for Result Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Touch the result records to recalculate.


Note: The selected records must contain results with an NC code and contain
No Result as the result.
4. Touch Recalculate Results.

Yes 5. Touch Yes.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-10 Version 2.0


View Samples in Process
1. Touch Results Review on the Main Menu screen (or its mini-button).

2. Touch View Sample Status to display a list of samples in process.

3. Optional: Define sort and filter criteria for the list of samples to view:
a. Touch Sample ID or Location to sort by sample ID or tray location.
Sample ID Location

b. Touch any or all sample types (Patient, Control, Calibrator).


Patient

Control

Calibrator

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-11 Version 2.0


c. Touch STAT or All.
STAT All

d. Touch Update List to update the list with the most current samples that
match the sort and filter criteria.

4. To view the status of each assay programmed for a sample, select the sample
program, then touch View Sample Detail.

Update List 5. Touch Update List to display current information for the assays.

OK 6. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-12 Version 2.0


Manage Reports

Change Report Statuses

Change Report Statuses for Records Matching General Search Criteria


1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Set Report Status on the Search/Review/Edit screen.

No Action Of f/Cancel Send 3. Touch No Action, Off/Cancel, Send, or Defer for each report type.

OK 4. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-13 Version 2.0


Change Report Statuses for Selected Records
1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Touch the result records to change the report statuses.

4. Touch Set Report Status.

No Action Of f/Cancel Send 5. Touch No Action, Off/Cancel, Send, or Defer for each report type.

OK 6. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-14 Version 2.0


Change Report Statuses and Edit Patient Data for One Record
1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Review/Edit on the Search/Review/Edit screen.

3. Touch the result record.

4. Touch Edit Pat Data.

5. Touch Set Report Status.

Of f Send Defer 6. Touch Off, Send, or Defer for each report type.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-15 Version 2.0


OK 7. Touch OK.

8. Touch Return/Save.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-16 Version 2.0


Release Deferred Reports
1. Search for result records that match your criteria. (Refer to “Search for Result
Records” on page 5-2.)
2. Touch Release Deferred.

or
Review or edit results before releasing them:
a. Touch Review/Edit on the Search/Review/Edit screen.

b. Review or edit result records displayed.

c. Touch Release Deferred.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-17 Version 2.0


Yes No
3. Touch Yes to release each report type.

OK 4. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 5-18 Version 2.0


6
Perform Quality Control

This chapter describes basic procedures to monitor the accuracy and precision of your VITROS®
ECi/ECiQ Immunodiagnostic System. To perform quality control, you process quality control
fluids for each analyte at regular intervals. For complete information and procedures on quality
control, refer to Chapter 9, “Performing Quality Control,” in the Operator’s Guide.
IMPORTANT: If this is the first time you are performing quality control, read Chapter 9,
“Performing Quality Control,” in the Operator’s Guide before continuing with
this procedure.
Review or Define Control Fluids

Review Control Fluids


1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK (or press Enter or touch
OK without typing your access code).
OK

3. Touch Define Controls.

4. Touch List All Controls.

5. Review the control fluids listed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-2 Version 2.0


thyhi thylow thymed 6. Optional: Touch a control fluid to view the defined analytes in the list box.

7. Touch Return/Cancel.

8. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-3 Version 2.0


Define or Edit Control Fluids
1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Define Controls.

Control ID: _______ 4. Type the Control ID (1–6 alphanumeric characters), then press Enter.

Control Name: _______________ 5. Type the control name (1–15 alphanumeric characters), then press Enter.

Lot Number: __________ 6. Type the lot number (1–10 alphanumeric characters), then press Enter.

Expiration 7. Type the expiration date, then press Enter.


Date: _________

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-4 Version 2.0


Plasma Urine
8. Touch a body fluid.
Serum

9. Touch the analytes you want to define for the control fluid.
TT4 T3U FT4
and
E2 Prog FSH
Deselect any analytes you want to delete for the control fluid.
L/F FT4I FT3I

10. Optional: Touch Define Baseline to define baseline statistics for the control
fluid. Define baseline statistics as follows:

Mean: __________ a. Type the mean (1–10 numeric characters), then press Enter.

SD: _____ b. Type the SD (1–5 numeric characters), then press Enter.

or
CV: ____ Type the CV (1–4 numeric characters), then press Enter.

c. Repeat steps a through b to define statistics for other analytes listed.

OK d. Touch OK.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-5 Version 2.0


11. Touch Save.

12. Touch Return/Cancel.

13. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-6 Version 2.0


Delete Control Fluids
1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Define Controls.

4. Delete one control fluid:


Control ID: _______ a. Type the Control ID (1–6 alphanumeric characters), then press Enter.

b. Touch Delete Control.

or
Delete several control fluids:

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-7 Version 2.0


a. Touch List All Controls.

yhi thylow thymed b. Touch the control fluids to delete.

c. Touch Delete Controls.

Yes 5. Touch Yes.

6. Touch Return/Cancel.

7. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-8 Version 2.0


Review and Edit QC Results

Review Results by Analyte


1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Review Data by Analyte.

4. Touch a body fluid.


Serum Plasma Urine

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-9 Version 2.0


5. Touch an analyte.
TT4 T3U FT4

E2 Prog FSH

L/F FT4I FT3I

thyhi thylow 6. Touch a control ID in the list box.

7. Optional: Touch Set Filter, define search criteria, then touch OK.

OK

8. Touch Review Results.

9. Review the information on the screen.


or
Touch a control result record to review or edit; then follow steps in the
appropriate section below, beginning on page 6-11.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-10 Version 2.0


Omit or Include Results in Statistical Calculation
1. Follow steps 1 through 8 in “Review Results by Analyte” on page 6-9.
2. Touch the control result record, then touch Expand Record.

3. Touch the result records to omit, then touch Omit Results.

or
Touch previously omitted results, then touch Include Results.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-11 Version 2.0


4. Touch Return until the main Quality Control screen is displayed.

Edit or Add Comments to a Result Record


1. Follow steps 1 through 8 in “Review Results by Analyte” on page 6-9.
2. Touch the control result record, then touch Expand Record.

3. Touch the result record.

4. Touch Edit/Add Comments.

Performance Integrity 5. Touch a category for the comment.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-12 Version 2.0


6. Touch one or two comments.

7. Touch Add - where space permits, Add - overwrite if necessary, or Remove.

OK 8. Touch OK.

9. Touch Return until the main Quality Control screen is displayed.

Edit Baseline Statistics for an Analyte


1. Follow steps 1 through 8 in “Review Results by Analyte” on page 6-9.
2. Touch the control result record, then touch Expand Record.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-13 Version 2.0


3. Touch Edit Baseline.

Update 4. Touch Update to use the record statistics for the baseline statistics.

or
Type baseline statistics:
Mean: __________ a. Type the mean (1–10 numeric characters), then press Enter.

SD: _____ b. Type the SD (1–5 numeric characters), then press Enter.

or
CV: ____ Type the CV (1–4 numeric characters), then press Enter.

OK c. Touch OK.

5. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-14 Version 2.0


Review Results by Control
1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Review Data by Control.

thyhi thylow thy 4. Touch a control ID (or type the control ID in the Locate field).

5. Optional: Touch Set Filter, define search criteria, then touch OK.

OK

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-15 Version 2.0


6. Touch Review Results.

7. Review the information on the screen.


or
Touch a result record to edit; then follow steps in the appropriate section
below, beginning on page 6-16.

Omit or Include Results in Statistical Calculation


1. Follow steps 1 through 6 in “Review Results by Control” on page 6-15.
2. Touch the result records to omit, then touch Omit Results.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-16 Version 2.0


or
Touch previously omitted results, then touch Include Results.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-17 Version 2.0


Edit or Add Comments to a Result Record
1. Follow steps 1 through 6 in “Review Results by Control” on page 6-15.
2. Touch the result record.

3. Touch Edit/Add Comments.

Performance Integrity 4. Touch a category for the comment.

5. Touch one or two comments.

6. Touch Add - where space permits, Add - overwrite if necessary, or Remove.

OK 7. Touch OK.

8. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-18 Version 2.0


Graph or Print QC Results

Graph Results or Print Reports by Analyte


1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Review Data by Analyte.

4. Touch a body fluid.


Serum Plasma Urine

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-19 Version 2.0


TSH TT4 T3U 5. Touch an analyte.

B-hCG E2 Prog

thyhi thylow 6. Touch a control ID in the list box.

7. Optional: Touch Set Filter, define search criteria, then touch OK.

OK

8. Graph or print results; follow steps in the appropriate section below,


beginning on page 6-20.

Graph Results by Analyte


1. Follow steps 1 through 7 in “Graph Results or Print Reports by Analyte” on
page 6-19.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-20 Version 2.0


2. Touch Graph Records.

or
Select specific records to include in the graph:
a. Touch Review Results.

b. Touch records to include.

c. Touch Graph Records.

or
Select specific results from a record:

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-21 Version 2.0


a. Touch Review Results.

b. Touch a record.

c. Touch Expand Record.

d. Touch results to include.

e. Touch Graph Record.

3. Optional: Print the graph displayed:


a. Touch Print Graph.

Individual Daily b. Touch Individual.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-22 Version 2.0


or

Individual Daily Touch Daily.

OK c. Touch OK.

4. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-23 Version 2.0


Print Reports by Analyte
1. Follow steps 1 through 7 in “Graph Results or Print Reports by Analyte” on
page 6-19.
2. Touch Print Records.

or
Select specific records to include:
a. Touch Review Results.

b. Touch records to include.

c. Touch Print Records.

or

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-24 Version 2.0


Select specific results from a record:
a. Touch Review Results.

b. Touch a record.

c. Touch Expand Record.

d. Touch results to include.

e. Touch Print Results.

3. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-25 Version 2.0


Print Reports by Control
1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Review Data by Control.

thyhi thylow thy 4. Touch a control fluid.

5. Optional: Touch Set Filter, define search criteria, then touch OK.

OK

6. Optional: Select specific records to include in the report:

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-26 Version 2.0


a. Touch Review Results.

b. Touch records to include.

7. Touch Print Records or Print Results.

8. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-27 Version 2.0


Graph Results or Print Reports by Interval
1. Touch Quality Control on the Main Menu screen (or its mini-button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Review/Define Cumulative.

4. Select intervals by analyte:


a. Touch Analyte.
Analyte Control

Plasma Urine
b. Touch a body fluid.
Serum

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-28 Version 2.0


TSH TT4 T3U c. Touch an analyte.

B-hCG E2 Prog

d. Touch one or more control fluids.


thyhi thylow thyme

or
Select intervals by control:
a. Touch Control.
Analyte Control

b. Touch a control fluid.


thyhi thylow thyme

TSH TT4 c. Touch one or more analytes.

L/F T3/T4

5. Touch Review Intervals.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-29 Version 2.0


6. Touch one or more intervals to include in the graph or report.

7. Graph or print results; follow steps in the appropriate section below,


beginning on page 6-31.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-30 Version 2.0


Display or Print Graphs by Interval
1. Follow steps 1 through 6 in “Graph Results or Print Reports by Interval” on
page 6-28.
2. Touch Graph Records.

3. Touch Print Graph.

4. Touch Individual.
Individual Daily

or
Touch Daily.
Individual Daily

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-31 Version 2.0


OK 5. Touch OK.

6. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-32 Version 2.0


Print Reports by Interval
1. Follow steps 1 through 6 in “Graph Results or Print Reports by Interval” on
page 6-28.
2. Touch Print Records.

3. Touch Return until the main Quality Control screen is displayed.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-33 Version 2.0


VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 6-34 Version 2.0
7
Back Up Data

This chapter describes the basic procedures to back up data. For complete information and
procedures on backing up data, refer to Chapter 4, “Monthly Maintenance,” in the Maintenance
& Diagnostics Guide. For complete information and procedures on using disk file and system
services, refer to Chapter 12, “Using System Services,” in the Operator’s Guide.
Make Backup Diskettes

Make Backup Diskettes Using the Options & Configuration Screen


1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Perform Backup/Archive.

4. Touch the types of data to back up.

5. Touch Start Backup.

6. Insert the appropriate diskette into the disk drive.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 7-2 Version 2.0


OK 7. Touch OK.

8. Remove, label, and store the diskette.


9. If additional diskettes are requested, repeat steps 6 through 8.
10. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 7-3 Version 2.0


VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 7-4 Version 2.0
8
Configure the System

This chapter describes some of the features used most often to customize the
VITROS® ECi/ECiQ Immunodiagnostic System. For complete information and procedures,
refer to:
• Chapter 7, “Programming Samples,” in the Operator’s Guide to configure assay panels.
• Chapter 11, “Configuring and Customizing Your System,” in the Operator’s Guide to
customize analyte parameters, review calibration data, perform user calibrations, and
configure and set system parameters.
Configure Assay Panels

Define Panels
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

2. Touch Options.
1 2 3

3. Touch Define Panels.

4. Touch the body fluid.


Serum Plasma Urine

5. Touch the panel button.


Pan 1 Pan 2 Pan 3

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-2 Version 2.0


Panel: ______ 6. Type the name of the panel (1–5 alphanumeric characters), then press Enter.

TSH TT4 T3U 7. Touch the assays to include in the panel.

B-hCG E2 Prog

+R
8. Optional: After touching an assay, touch +R the number of times you want to
replicate the assay. Continue touching assays and touching +R after each, if
desired.
9. Optional: Touch Assay Dil, then type a dilution factor.

10. Optional: Touch Review/Edit Dilutions to review and edit dilution factors and
to add and delete replicates for assays.

11. Touch Save Panel.

12. Optional: Repeat steps 4 through 11 to define additional panels.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-3 Version 2.0


13. Touch Return/Cancel.

14. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-4 Version 2.0


Edit Panels
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

2. Touch Options.
1 2 3

3. Touch Define Panels.

4. Touch the body fluid.


Serum Plasma Urine

5. Touch the panel button.


Pan 1 Pan 2 Pan 3

6. Change the name, assays, or replications.


7. Touch Save Panel.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-5 Version 2.0


8. Touch Return/Cancel.

9. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-6 Version 2.0


Delete Panels
1. Touch Sample Programming on the Main Menu screen (or its mini-button).

2. Touch Options.
1 2 3

3. Touch Define Panels.

4. Touch the body fluid.


Serum Plasma Urine

5. Touch the panel button.


Pan 1 Pan 2 Pan 3

6. Touch Delete.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-7 Version 2.0


Yes 7. Touch Yes.

8. Touch Return/Cancel.

9. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-8 Version 2.0


Configure Analyte Data

Configure Units
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Configure Analytes.

4. Select the body fluid and analyte.


Serum Plasma Urine

TT4 T3U FT4

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-9 Version 2.0


5. Touch Review/Edit Analyte Data.

Conventional Alternate 6. Touch Conventional.

or
Conventional Alternate Touch Alternate.

7. Touch Return/Save.

8. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-10 Version 2.0


Configure Reference Ranges
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Configure Analytes.

4. Select the body fluid and analyte.


Serum Plasma Urine

TT4 T3U FT4

5. Touch Review/Edit Analyte Data.

6. Touch the box corresponding to the Reference range.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-11 Version 2.0


_______ to _______ 7. Type a value (0–100000) for the lower range limit and for the upper range
limit; press Enter after each.
Note: If you are configuring T3U, the values you type in Conventional units
will be from 6.00–99.0, the values you type in Alternate units will be from
0.42–27.4, or you can configure the mean normal value to adjust the range.
8. Touch Return/Save.

9. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-12 Version 2.0


Configure Supplementary Ranges
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Configure Analytes.

4. Select the body fluid and analyte.


Serum Plasma Urine

TT4 T3U FT4

5. Touch Review/Edit Analyte Data.

6. Touch the box corresponding to the Supplementary range.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-13 Version 2.0


_______ to _______ 7. Type a value (0–100000) for the lower range limit and for the upper range
limit; press Enter after each.
Note: If you are configuring T3U, the values you type in Conventional units
will be from 6.00–99.0, the values you type in Alternate units will be from
0.42–27.4, or you can configure the mean normal value to adjust the range.

Yes No
8. Touch Yes to display and report results outside the supplementary range (or
touch No.)
9. Touch Return/Save.

10. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-14 Version 2.0


Configure System Settings

Set System Sounds and Screensaver


1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure System.

4. Touch Sound/Screensaver.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-15 Version 2.0


5. Touch the appropriate buttons to:
• select tones
• set volumes
• enable or disable the bar code beeper
or
Type a value for screensaver delay.
6. Touch Return/Save.

7. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-16 Version 2.0


Set the Date and Time
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure System.

4. Touch Date/Time.

5. Touch the appropriate buttons to select date and time formats.


or
Type a new date or time.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-17 Version 2.0


6. Touch Return/Save.

7. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-18 Version 2.0


Enter the System Name or ID
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK

3. Touch Configure System.

4. Touch System Name.

System Name: ________ 5. Type a new system name (1–7 alphanumeric characters) or ID (1–9
System ID: __________ alphanumeric characters).

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-19 Version 2.0


6. Touch Return/Save.

7. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-20 Version 2.0


Configure Report Destination, Printing, and Transmission

Designate Destination Printers


1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure Report Control.

On Of f
4. Touch On or Off for Printer 1 and Printer 2.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-21 Version 2.0


5. Touch Return/Save.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-22 Version 2.0


Select Destination Printers for Each Report Type
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure Report Control.

1 2
4. Touch 1 or 2 for each report type.

5. Touch Return/Save.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-23 Version 2.0


Specify Report Status Defaults
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure Report Control.

Of f Send Defer 4. Touch Off, Send, or Defer for each report type.

5. Touch Return/Save.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-24 Version 2.0


Set Report Transmission
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure Report Control.

Yes No
4. Touch Yes or No for each report type and laboratory computer.

5. Touch Return/Save.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-25 Version 2.0


Enable Requests from Your Laboratory Computer
1. Touch Options & Configuration on the Main Menu screen (or its mini-
button).

OK 2. Touch OK (or press Enter).

3. Touch Configure Report Control.

Yes No
4. Touch Yes or No to receive requests.

5. Touch Return/Save.

6. Touch Return.

VITROS ECi/ECiQ Immunodiagnostic System Quick Guide 8-26 Version 2.0


IVD

Ortho-Clinical Diagnostics
Johnson & Johnson
50 - 100 Holmers Farm Way
EC REP
High Wycombe
Buckinghamshire HP12 4DP
United Kingdom

Ortho Clinical Diagnostics, Inc.


100 Indigo Creek Drive
Rochester, NY 14626

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