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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.
STRONGLY
STRONGLY
AGREE AGREE DISAGREE DIS-
AGREE
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
Please provide any comments about the online help function:________________________________________________________
_________________________________________________________________________________________________
Please write additional comments here: __________________________________________________________________________
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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 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.
Chapter 8: Configure the System. Basic procedures to customize your system with frequently
used configurable features.
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.
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.
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.
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
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
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
seconds.
Un
r ica
or
Cancel the startup process by touching Final Shutdown within 10 seconds.
Access Code: _______ b. Type your access code, then touch OK (or press Enter or touch OK
without typing your access code).
OK
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.
or
c. When final shutdown is complete, move the main power switch to the Off
position.
7. Power off the printer.
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
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.
10. If this is a new reagent lot number, perform calibration. (Refer to Chapter 5,
“Performing Calibration,” in the Operator’s Guide for instructions.)
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).
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.
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.
d. Touch Return.
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.
STAT e. If you want to give the program immediate priority, touch STAT.
g. Touch Save/Next.
7. Review the calibration report to ensure that the calibration was successful.
8. After calibration is complete, perform quality control procedures.
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.
B-hCG E2 Prog
5. Touch Review Calibrations.
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.
to L/F FT4I FT 5. Touch the assays or panels to process for the sample.
1 Pan 2 Pan 3
Special
8. Touch Save/Next.
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.
to L/F FT4I FT 6. Touch the assays or panels to process for the sample.
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.
to L/F FT4I FT 4. Touch the assays or panels to process for the samples.
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
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.
or
OK Touch OK.
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.
OK c. Touch OK.
8. Touch Save/Next.
9. Touch Return.
2. Touch Options.
1 2 3
c. Review the displayed Tray IDs. (Refer to the Operator’s Guide for
information on deleting programs using the Review Tray IDs screen.)
or
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.
2. Touch Options.
1 2 3
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.
or
Go to step 7.
7. Touch Sample Processing on the status console.
Note: Touch Sample Processing again to stop sample metering.
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
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.
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
or
OK b. Touch OK.
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.
c. Touch the result field to edit, type a result, then press Enter.
d. Repeat step c to edit additional results.
Prog FSH LH
OK e. Touch OK.
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.
Of f Send Defer b. Touch Off, Send, or Defer for each report type.
OK c. Touch OK.
9. Touch Return/Save.
6. Touch Return.
6. Touch Return.
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
Control
Calibrator
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.
No Action Of f/Cancel Send 3. Touch No Action, Off/Cancel, Send, or Defer for each report type.
OK 4. Touch OK.
No Action Of f/Cancel Send 5. Touch No Action, Off/Cancel, Send, or Defer for each report type.
OK 6. Touch OK.
Of f Send Defer 6. Touch Off, Send, or Defer for each report type.
8. Touch Return/Save.
or
Review or edit results before releasing them:
a. Touch Review/Edit on the Search/Review/Edit screen.
OK 4. Touch OK.
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
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
7. Touch Return/Cancel.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
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.
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.
OK d. Touch OK.
13. Touch Return until the main Quality Control screen is displayed.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
or
Delete several control fluids:
6. Touch Return/Cancel.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
E2 Prog FSH
7. Optional: Touch Set Filter, define search criteria, then touch OK.
OK
or
Touch previously omitted results, then touch Include Results.
OK 8. Touch OK.
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.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
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
OK 7. Touch OK.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
B-hCG E2 Prog
7. Optional: Touch Set Filter, define search criteria, then touch OK.
OK
or
Select specific records to include in the graph:
a. Touch Review Results.
or
Select specific results from a record:
b. Touch a record.
OK c. Touch OK.
or
Select specific records to include:
a. Touch Review Results.
or
b. Touch a record.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
5. Optional: Touch Set Filter, define search criteria, then touch OK.
OK
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
Plasma Urine
b. Touch a body fluid.
Serum
B-hCG E2 Prog
or
Select intervals by control:
a. Touch Control.
Analyte Control
L/F T3/T4
4. Touch Individual.
Individual Daily
or
Touch Daily.
Individual Daily
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
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
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.
2. Touch Options.
1 2 3
9. Touch Return.
2. Touch Options.
1 2 3
6. Touch Delete.
8. Touch Return/Cancel.
9. Touch Return.
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
or
Conventional Alternate Touch Alternate.
7. Touch Return/Save.
8. Touch Return.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
9. Touch Return.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
Yes No
8. Touch Yes to display and report results outside the supplementary range (or
touch No.)
9. Touch Return/Save.
4. Touch Sound/Screensaver.
7. Touch Return.
4. Touch Date/Time.
7. Touch Return.
Access Code: _______ 2. Type your access code, then press Enter or touch OK.
OK
System Name: ________ 5. Type a new system name (1–7 alphanumeric characters) or ID (1–9
System ID: __________ alphanumeric characters).
7. Touch Return.
On Of f
4. Touch On or Off for Printer 1 and Printer 2.
6. Touch Return.
1 2
4. Touch 1 or 2 for each report type.
5. Touch Return/Save.
6. Touch Return.
Of f Send Defer 4. Touch Off, Send, or Defer for each report type.
5. Touch Return/Save.
6. Touch Return.
Yes No
4. Touch Yes or No for each report type and laboratory computer.
5. Touch Return/Save.
6. Touch Return.
Yes No
4. Touch Yes or No to receive requests.
5. Touch Return/Save.
6. Touch Return.
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