Access2 Operator's Guide New
Access2 Operator's Guide New
Access2 Operator's Guide New
C85818-AA
May 2022
Printed in U.S.A.
© 2022 Beckman Coulter, Inc. All rights reserved.
Beckman Coulter, Inc. • 250 S. Kraemer Blvd. • Brea, CA 92821 • U.S.A.
https://www.beckmancoulter.com
Publication Notes
This manual, P/N C85818-AA, release date 2022-05, supports:
• Access 2 published system software version 3, including full versions 3.4.2, 3.4.3, 3.5.0, 3.6.0, and
3.7.0.
• Access 2i published operating software version 6, including full versions 6.2.2, 6.2.3 and 6.3.0
Revision History
C42384, January 2020 Access 2 software versions 3.4.2, 3.4.3, 3.5.0, 3.6.0, and 3.7.0
Access 2i software verrsions 6.2.2, 6.2.3, and 6.3.0
C30215, December 2018 Access 2 software versions 3.4.2, 3.4.3, 3.5.0, and 3.6.0
Access 2i software verrsions 6.2.2, 6.2.3, and 6.3.0
C02060-AB, July 2017 Access 2 software versions 3.4.2, 3.4.3, and 3.5.0
Access 2i software verrsions 6.2.2 and 6.2.3
B14251F, July 2016 Access 2 software versions 3.4.2 and 3.4.3
Access 2i software versions 6.2.2 and 6.2.3
B14251E, February 2015 Access 2 software version 3.4.2 and Access 2i software version 6.2.2
This guide is intended for use with the Access 2 Immunoassay System. This guide also can be used as
supplemental material for the UniCel DxC 600i system, which consists of an Access 2 system integrated with a
UniCel DxC 600 system.
© 2022 Beckman Coulter, Inc.
Beckman Coulter, Inc. grants a limited non-exclusive license to the Access 2 system owner or operator to make
a copy of all or a portion of this book solely for laboratory use.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered
trademarks of Beckman Coulter, Inc. in the United States and other countries.
Citranox is a registered trademark of Alconox, Inc.
Contrad is a registered trademark of Decon Laboratories, Inc.
Monovette is a trademark of Sarstedt A.G. & Co.
All other trademarks are the property of their respective owners.
Access 2 Operator's Guide Table of Contents
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-1
2 Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 Wash Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.3 Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.4 Substrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
2.5 Reaction Vessels (RVs). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
2.6 Reaction Vessel Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
2.7 Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
2.8 Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Index-1
Preface
About the Operator’s Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
About the This Operator's Guide provides the step-by-step information needed for everyday
Operator’s operation of the Access 2 system. The Operator's Guide contains the following
Guide chapters:
Using the To make information easier for you to find and use, Access 2 system documentation
Manual uses the following standards and styles.
Chapter Organization
Most of the chapters in the Operator's Guide and Reference Manual contain
flowcharts, screen and window captures, tables of screen or window item
descriptions, and procedural or informational sections.
Screens and complex windows are illustrated in the manuals if you need explanations
of their contents to understand how to perform a procedure. Simple windows that are
self-explanatory are not included.
For a list of system status button names and descriptions, see Chapter 1: System
Overview.
NOTES
• For consistency as illustrated in the previous examples, whether you touch
the screen, point and click with the mouse, or press [Tab] to select a text
button, system command button, or an option in a field, this documentation
uses the term select.
• For information about how to navigate through the Help system system, see
Using the Help System on page Preface-6.
Keys
When you perform an action exclusively with the keyboard, the key name or
description is provided in bold type, in brackets. For example:
Required Steps
Required steps in a procedure are indicated by sequentially numbered lists in the Help
system, and by numbered boxes in the manuals. For example:
Optional Steps
Optional steps in a procedure are indicated by an asterisk and the word (Optional) in
the Help system. Small, unnumbered boxes and the word (Optional) are used in the
manuals. For example:
(Optional) This is an optional step in a procedure (manual).
Optional steps provide information about how to perform a task that you only need to
do under some circumstances. For example, required steps in the Printing the Reagent
Inventory Report procedure tell you how to print the report including all reagent
packs. The optional step tells you how to print the report for selected packs only.
Help System The Access 2 Help system system provides all of the information contained in the
Operator's Guide and Reference Manual in a convenient online format that you can
access from within the Access 2 system software.
The following books (or pages) are contained in the Help Topics window, which can
be viewed by using the Contents tab:
About the General information about how to use the system, what you
Access 2 can do from the Main Menu, and information about the
Immunoassay warranty.
System
About Help Information about the Access 2 Help system system and
system how to use it.
Publication Information about changes to the Access 2 Immunoassay
Notes System documentation.
Access 2 Information about additional documentation for the
Manuals Access 2 Immunoassay System, which is available in
printed form or in online form on CD.
Glossary An alphabetical list of terms and definitions specific to the
Access 2 system.
Using the When you select the Help system from any Access 2 system software screen, a Help
Help System system window is displayed. From the Help system window, you can use the Help
system window button bar to perform operations (print or copy) on the currently
displayed topic or to navigate to a different topic.
You can access the Help system system from any system software screen and from
some system software windows by pressing a Help button or [F12] Help on the
keyboard.
Help from a On screens, the Help button is the round system status
Screen button with a question mark (?).
A screen also has function buttons, a Menu tab, system
command buttons, and system status buttons. For more
information about screens, see Chapter 1: System
Overview.
When you select Help from a screen, the Help system
system displays information about the screen you are on
and provides a button you can select to view the screen and
its description.
Help from a In windows, the Help button is the rectangular Help F12
Window function button in the lower right corner.
A window may provide information about the status of the
system or ask you a question that requires your response.
For more information about windows, see
Chapter 1: System Overview.
When you select Help from a window, the Help system
system displays procedural information related to the
window you are in. Sometimes you can view the window
and its description from the Help system system, and
sometimes you can view a flowchart of the procedure.
Help from Help From any displayed Help system topic, you can go to other
topics using Help system navigational features such as
Help system link buttons, the Help system window button
bar, the Help Topics window (tabs), the [F12] Help key on
the keyboard, and the highlighted text (green).
Button Description
NOTE
For the Japanese and Simplified Chinese languages,
the See Also button is not available.
(Flowchart button) Select to display a flowchart of the
procedure or overview.
You can find this button at the top of a procedure window.
Button Description
Help Windows
The Help system for the Access 2 system uses standard window types to display
different types of information:
• Procedure (narrow window displaying on the right of the screen, usually lists
steps to perform)
• Main (widest window displaying in the center of the screen, usually includes
a column of arrow buttons on the left to link to more information)
• Picture (wide window displaying on the left of the screen, usually shows a
screen, window, flowchart, or a picture of a portion of the instrument)
• Glossary (narrow window displaying on the right of the screen, usually lists
items to link to, such as term definitions or event information)
• Popup (window displaying anywhere on the screen, usually provides a brief
definition or description of an item and has no button bar or scroll bar)
When you display a Help system window, it continues to be displayed until you
display another window of the same type, select any part of the UI software visible
beyond the edges of a Help system window, or exit the Help system system.
Exit the Help system system by selecting Exit from the Help system window button
bar.
NOTE
Select Exit only when you are finished using the Help system system. When you
select Exit, all Help system windows close.
NOTE
For the Japanese and Simplified Chinese languages, the Find button is not
available.
0862b.bmp
Figure 5 Help Window Button Bar
Find (Button) Displays the Help system Find tab in the Help
Topics window, which allows you to search for a topic by
keywords.
For more information on the Find feature, see the Help
system Find Feature topic later in this preface.
Help Topics (Button) Displays the Help system Topics window. From
this window, you can search the entire Help system system
and go directly to any topic.
For more information, see the Help Topics Window topic.
Back (Button) Select to return to the last displayed topic in the
same type of window (such as a procedure window or a
picture window).
This button is unavailable if the topic displayed is the first
topic for that type of window.
Print (Button) Select to print the displayed topic.
Glossary (Button) Select to display the Help system system glossary.
This button is only available from main (large) Help
system windows.
Exit (Button) Select to exit the Help system system.
Help Window The Help system window menu contains features that are
Menu duplicates of others found in the Help system system and
features that can change Help system appearance and
performance. The Help system system has been optimized
for your use. You should not access the features in the Help
system window menu.
Select a topic
page to
display
Select a topic
book to
display the
contents
0603b.bmp
Figure 7 Help Topics Window (Contents View)
Contents (Tab) Select to display the table of contents for the Help
system system.
From the table of contents, you can:
• Select a topic page (the white icon with ? inside) to
display Help about the topic.
• Select a topic book, which expands to list more available
topic pages and books related to the topic book.
NOTE
For the Japanese and Simplified Chinese languages,
scrolling is the only method of locating information in
the index.
Find (Tab) Select to search for a topic by keywords.
For more information on the Help system Find feature, see
the Help system Find Feature topic in this preface.
The first time you use the Find feature, the Find Setup Wizard window is displayed.
Before you can use this feature, the Help system system must create a database to
search from available database options.
• When you select Minimize database size, the Find feature displays a list of
the main topics containing the word you enter. Minimum is the default and
the recommended choice.
• When you select Maximize search capabilities, the Find feature displays a
list of every topic containing the word you enter. When you select this
option, the Find feature may operate at a slower rate.
• When you select Customize search capabilities, you select the
characteristics of the Find feature in response to questions provided by the
Find Setup Wizard.
After you select a database option, select Next and then select Finish. The Help
system system creates the database and displays the Find window.
NOTES
• The Help system system creates the Find database only the first time you
select the Find feature.
• For the Japanese and Simplified Chinese languages, the Find feature of the
Help system system cannot be used.
0857b.bmp
Figure 9 Help Topics Window (Find View)
Notes, Cau- The Access 2 system documentation uses notes, cautions, and warnings to draw your
tions, and attention to important information, instrument operation instructions, and safety
Warnings information.
Help Manual
Description
Icon Graphic
NOTE
Be prepared to provide your system ID.
1 System Overview
1.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
The Access 2 system is an in vitro diagnostic device used for the quantitative,
semi-quantitative, or qualitative determination of various analyte concentrations
found in human body fluids.
The system processes patient, quality control, and calibration samples in individual,
disposable, plastic tubes called reaction vessels (RVs) with reagent from up to 24
onboard reagent packs.
The Access 2 system provides random, continuous, and STAT access. Random access
allows you to perform any assay on any sample, using onboard reagent packs.
Continuous and STAT access allow you to schedule additional or STAT samples,
replenish most supplies, and change waste containers while the instrument is
processing samples. The system schedules assays as defined by the assay protocol file
(APF) for each assay, and ensures adequate supplies to complete the assays. When a
STAT assay is added, the instrument automatically reschedules other samples in a run
to process the STAT sample first.
The Access 2 system can operate in workgroups of 1to 4 instruments, depending upon
your lab requirements.
For information about the Access 2 system, instrument, and assay technology, see
Chapter 1: Technology Overview in the Reference Manual.
The Access 2 system uses the following six instrument hardware modules to
accomplish sample processing:
• The carousel module includes the sample carousel, reagent carousel, cup/tube
detector, internal sample bar code reader, and internal reagent bar code reader
(if equipped). The sample carousel holds the racks. The reagent carousel
holds the reagent packs. The cup/tube detector identifies if a sample
container is present in each position on the rack. The internal sample bar code
reader scans bar-coded rack and sample container information.The internal
reagent bar code reader (on instruments with serial numbers ≥570000) reads
the printed bar code label on the reagent packs..
• The main pipettor module includes the pipettor gantry, main pipettor,
precision pump, and ultrasonic transducer. This module transfers samples,
reagents, and wash buffer (for dilutions, if necessary) to the reaction vessels.
• The analytical module includes the reaction vessel loader, incubator belt, and
wash/read carousel. This module transports reaction vessels through
incubation, washing, addition of substrate, luminometer reading, and
transmits the reading to the electronics module.
• The fluidic module includes the probe wash tower, vacuum pump, vacuum
reservoir, substrate pump, wash pump, waste pump, and fluids tray. This
module works together with the main pipettor module and the analytical
module to dispense reagents and samples, wash the samples and the probes,
dispense substrate, and store liquid waste.
• The electronics module includes a power supply, reset button, interlock
switch, reaction vessel load door alarm, printed circuit boards, internal hard
drive, status light bar (on instruments with serial numbers ≥570000), and
sometimes a 3.5-inch disk drive for troubleshooting the system.
• The peripherals module includes the external computer, keyboard, pointing
device (mouse), monitor, printer, and external bar code reader. The external
computer has its own hard drive, 3.5-inch disk or USB flash drive, CD-ROM
or DVD drive, modem, and backup tape or USB flash drive. You use the
peripheral components to direct and monitor the Access 2 system through the
system software, to make a backup of your system data, to copy data, and to
print reports.
For more information about instrument technology, see Section 1.2: Instrument
Technology in the Reference Manual.
Installation The Access 2 Immunoassay System must be installed by a qualified Beckman Coulter
technical support representative. Do not remove the instrument from the shipping
crate until a technical support representative is present.
Warranty The Access 2 Immunoassay System is covered by and subject to the provisions of the
warranty included in your contractual agreement for the system and/or its reagents.
Safety Fea- The Access 2 Immunoassay System is designed to meet U.S. and international safety
tures standards. Safety labels are affixed to the instrument to alert you to safety
considerations, and an interlock switch stops the movement of the main pipettor to
protect you from injury if you were to open the front panel of the instrument while the
system was running.
Interlock Switch
WARNING
Do not defeat the safety interlock switchon the cover.
The Access 2 system is equipped with an interlock switch to protect you from injury.
If you open the front panel of the instrument, the interlock switch stops the movement
of the main pipettor. Other mechanical devices will continue to operate with the front
panel open. If you open the front panel while the system is processing samples, the
system may cancel tests.
Safety Sym- Certain areas of the Access 2 instrument present a risk of personal injury or damage to
bols and the instrument if proper safety procedures are not followed. These areas are marked
Statements with one or more safety symbols to identify the hazard. These symbols are defined in
the Access Immunoassay Systems Symbol Glossary, available at
techdocs.BeckmanCoutler.com.
Laser Symbol
The laser symbol indicates areas of the instrument where laser light is used. Do not
stare into the laser beam.
2208A.eps
Figure 1-1 Laser Symbol
Safety Statements
The following statements describe general safety concerns and provide information
about attention symbols with no accompanying text.
WARNINGS
• Reagents, calibrators, and controls used with the system may contain small
quantities of sodium azide preservative. Sodium azide preservative may
form explosive compounds in metal drain lines. Refer to National Institute
for Occupational Safety and Health Bulletin: Explosive Azide Hazards
(8/18/76).
• The Access 2 instrument has moving parts and uses high voltage in the
ultrasonic transducer. Both present an injury hazard. You should not
operate the Access 2 instrument with the covers open.
CAUTION
Always plug the Access 2 system into a grounded three-conductor outlet. DO
NOT bypass the grounding prong on the plug.
Regulatory The Access 2 Immunoassay System meets the requirements of a variety of domestic
Symbols and and international regulatory agencies, standards, and directives. This compliance is
Statements indicated by symbols and marks on the instrument, and by related statements in the
system documentation. These symbols are defined in the Access Immunoassay
Systems Symbol Glossary, available at techdocs.BeckmanCoulter.com.
Notice to User
For a patient/user/third party in the European Union and in countries with identical
regulatory regime (Regulation 2017/746/EU or In vitro Diagnostic Medical Devices):
if, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and/or its authorized representative and to your
national authority.
CAUTIONS
• This equipment has been designed and tested to CISPR 11 Class A. In a
domestic environment it could cause radio interference, in which case
you may need to take measures to mitigate the interference.
• Prior to operation of this device, the electromagnetic environment
should be evaluated. Do not use this device in close proximity to sources
of strong electromagnetic radiation (for example, unshielded intentional
RF sources) as these could interfere with proper operation.
• If you suspect interference between the Access 2 system and other
equipment, you must take whatever action is required to correct the
interference. Beckman Coulter suggests the following actions:
1. Move the equipment so there is a greater distance between the
equipment and the Access 2 system.
2. Re-orient the equipment with respect to the Access 2 system.
3. Be sure the equipment is operating from a different power service
connector than that of the Access 2 system.
The system software functions are organized into a set of screens that have common
elements. From any screen, you can run, pause, or stop the instrument, monitor the
system mode, access the Help system, view the Event Log, select options to operate
the system, and go to other screens.
NOTES
• Your ability to perform these functions can depend upon the system mode of
the instrument. For example, it is not possible to select Run when the
instrument is in the Not Ready mode.
• You cannot select Run from a limited number of screens, such as the
Diagnostics screen.
The system will sometimes display a smaller window on top of a screen to prompt
you to perform an action, confirm that you want the system to perform an action,
display a message, or allow you to enter information. When entering information in a
window, you can use basic keyboard commands, such as Ctrl+C (copy) or Ctrl+V
(paste), to transfer information between windows. For example, you can copy a
comment from the Sample Comments window and paste it in the same window for
another sample, or copy and paste a formula when setting up derived results.
The software also comes with a Laboratory Information System (LIS) feature, which
allows an external LIS to communicate with a workgroup through one LIS serial line.
Test requests entered at the LIS are transmitted to the workgroup for processing. Once
processing is complete, the test results are sent back to the LIS system. The
workgroup data is managed from a single computer acting as the workgroup server.
For more information about instrument technology or the LIS system, see Chapter 1:
Technology Overview in the Reference Manual.
For more information about setting up an LIS system, see section 4.9 LIS Setup in the
Reference Manual.
Running Only the Access 2 software should be installed on your PC. If a software application
Other Appli- other than the authorized Access 2 Immunoassay System software is detected on your
cations PC, it must be removed.
Main Menu The Main Menu is the first screen you see when the system is installed or initialized.
To get to this menu from any screen, press [F9].
You can navigate everywhere through the Access 2 system using the eight function
buttons across the bottom of the Main Menu (see Figure 1-2). These buttons are direct
routes to the functions you perform most frequently.
The Main Menu function buttons are available from other screens when you use the
Menu tab. The Menu tab displays along the right edge of every screen except the
Main Menu.
0622D.bmp
Figure 1-2 Main Menu
Main Menu
Description
Function Button
Sample Select to display the Sample Manager screen. You use this screen to:
Manager F1 • Define racks in the system, load or unload them, or delete them from the system
• Add samples to, or remove samples from racks
• Display the Test Requests screen to enter test requests and check on their progress
• Request maintenance routines
• Review tests on the Work Pending screen
For more information see Chapter 3: Sample Management and see Chapter 4: Sample
Processing.
Test Results F2 Select to display the Test Results screen. You use this screen to:
• View test results and associated result flags
• Print test result reports or copy test result data to a disk
• Rerun a test after reviewing its results
For more information about Test Results, see Chapter 5: Test Results.
Supplies F3 Select to display the Supplies screen. You use this screen to:
• Check the status of all system supplies
• Replenish bulk supplies
• Load and unload reagent packs and review the reagent inventory
For more information about Supplies, see Chapter 2: Supplies.
Quality Select to display the Quality Control screen. You use this screen to:
Control F4 • Set up quality controls
• Review, compare, or print quality control information
For more information, see Chapter 7: Quality Controls.
Calibration F5 Select to display the Calibration screen. You use this screen to:
• Set up calibrators
• View the results of assay calibrations
• Print calibration reports
For more information, see Chapter 6: Assay Calibrations.
Main Menu
Description
Function Button
Maintenance Select to display the Maintenance Review screen. You use this screen to:
Review F6 • Review system temperatures
• Run or disable the Utility Assay
• Review system check results
For more information, see Chapter 8: Routine Maintenance.
Diagnostics F7 Select to display the Diagnostics menu. You use this menu to:
• Initialize the system or align and home devices
• View information from various instrument sensors
• Perform diagnostic or troubleshooting procedures as instructed in system
documentation or by Technical Support
For more information, see Chapter 5: Diagnostics in the Reference Manual.
Configure F8 Select to display the Configure menu. You use this menu to:
• Set up system and LIS information, test result ranges, test panels, derived results,
and reflex tests for your laboratory
• Enable and disable tests and test panels
• Set up or change the system password
• Back up and restore system data
For more information, see Chapter 4: System Configuration in the Reference Manual.
Main Menu Select one of the Main Menu function buttons to display the associated screen. You
Workflow will see another row of function buttons across the bottom of the screen. You can
select these buttons to perform an action or to display a menu with additional function
buttons. The flowchart (see Figure 1-4) outlines the workflow for each of the Main
Menu function buttons.
F1 Load Rack /
Get/Edit Rack
F2 Delete Sample
F3 Show/Hide
F1 Load a Rack
Test Menu
F2 Work Pending
F4 Test Results
F3 Test Request
Sample Manager F5 Request QC
F4 Maintenance Request
F1 F6 Request
F6 Get Selected Rack
Calibration
F7 Clear Selected Rack
F7 Clear All
F8 Change Rack ID
Samples
F8 More Options F1 Filter
F2 Review Data
Calibration
F5 Calibrator Setup
F5
F6 Delete
F7 Print
F1 Filter
F2 Find
F3 Rerun Test
F4 Sample Details
F5 Send to LIS
Test Results
F6 Copy to Disk
F2 F1 Report
F7 Print
F2 Completed Samples
F1 Refresh Screen
F2 Configure Screen F2 System Checks
F8 More Options
F3 Delete Data F5 Run Utility Assay
Maintenance Review
F6 Enable/Disable Utility
F6
Assay
F7 Print
F1 System Revisions
F1 Filter F2 Bar Code
F2 Review Chart Reader Setup
and Data F1 System Setup F3 Set Workgroup
Quality Control
F3 Compare Charts Date/Time
F4
F4 Delete Comparison F5 Password Setup
F5 QC Setup F7 Reports Setup
F7 Print
F1 Filter
F2 Edit Units
F3 Ranges
Configure F2 Tests F4 Gray Zone
F8 F5 Special
F7 Print
F8 Update APF
F3 Test Panels
F4 Derived Results
F1 Scheduled Backup
F5 Reflex Tests
F2 Immediate Backup
F6 LIS
F3 Eject Tape
F7 PC Admin
F4 Restore
F8 About Access 2
F5 Auto-Delete Setup
F8 Shut Down PC
0863E.wmf
Figure 1-4 Main Menu Work Flow
Common The Access 2 system displays certain elements on every screen so you can
Screen Ele- continuously monitor the status of the system (see Figure 1-5).
ments
Scroll
Bar
System
Command
Buttons
Scroll
Bar
Back
Tab
Menu
Tab
Status
Line
Function
Buttons
0711B.bmp
Figure 1-5 Common Access 2 System Screen Elements
System Modes
The Access 2 system has four system modes (see Table 1-6) that indicate the
operating state of the system. The current mode is displayed in the upper left corner of
each screen. When the system is in the Running mode, the estimated completion time
for the requested function is displayed as a text line above the three system command
buttons. Additional system messages are displayed at various times at this location.
Some instruments are equipped with a status light bar that changes color to indicate
the operational status of the instrument (see Figure 7-1 in the Reference Manual). The
color of the light bar matches the color of the system mode area of the user interface.
Status
Mode Screen Display Light Bar Description
Color
Screen
Button Description
Display
Most buttons are color-coded to alert you when a supply level requires your attention,
a sample processing issue exists, or the instrument has recorded a system event.
Under normal operating conditions the color of the button is neutral. The color of
some buttons can change to yellow to indicate a caution condition or red to indicate a
warning condition. The Help button color is always neutral.
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
Scroll Bar
The scroll bar displays along the right side or bottom of some screens. Use the scroll
bar to view areas that are out of the normal viewing area of the screen. Select the
arrows at either end of the scroll bar to move through the screen line-by-line, or drag
the icon within the scroll bar to pass through the screen rapidly.
Arrow Buttons
Arrow buttons are displayed at either end of some horizontal and vertical data labels.
Select the arrow buttons to view data that is out of the normal viewing area of the
screen, like the arrows buttons at either end of a scroll bar.
When there is a blue line cursor over a data point on the screen, that point is selected.
Selecting an arrow button moves the cursor and selects the next data point in the
direction of the arrow. Additional data associated with a point may be available when
a data point is selected.
0649A.bmp 0650A.bmp
Function Buttons
The Access 2 system displays a row of eight function buttons across the bottom of
each screen. Selecting a function button performs an action or displays a menu of
additional function buttons.
Function buttons vary from screen to screen, according to the operations you can
perform on each screen.
Function Button
Description
Example
Information Fields
Some screens require that you enter pertinent information into a field. You can enter
information only when the field is available.
NOTE
Do not enter a quotation mark (") in an available field. Although some fields may
accept quotation marks, characters to the right of the quotation mark may not
print on reports.
Status Line
The status line displays the system ID and the current date and time. It may also
display other information, such as what activity the system is currently performing, or
what to enter in a selected field.
System Navi- The Access 2 system has three navigation methods that you can use in any
gation combination:
• Touching part of the screen using the tip of your finger or fingernail.
• Clicking the left mouse button to select an item on the screen.
• Pressing a keyboard equivalent such as a function key, tab key, or arrow key
to select a field or other item on the screen.
Keyboard Equivalents
The following table lists the equivalent keystrokes you can use to perform common
functions on the Access 2 system.
The word enter is applied throughout the system documentation to signify putting
information into a field. Depending on the options available for the field, you can
enter information using one of the following methods:
• Type the information from the keyboard.
• Select the information by checking a box or choosing an item from a list.
This will enter the information you selected into the appropriate field.
• Scan bar coded information with the external bar code reader.
Common Win- The Access 2 system displays a window to provide information, ask you to respond to
dows a question, prompt you to perform an action, or confirm that you want the system to
perform an action. Illustrations of many windows, particularly those that are
complicated, are included in the Help system procedures.
0920A.bmp.
Figure 1-13 OK/Cancel/Help Window Example
The OK F1, Cancel F8, and Help F12 buttons are common buttons. This section
provides an explanation of these buttons. Common buttons will not be explained
again in the remaining chapters of the Operator's Guide or Reference Manual.
Reports You can print reports as well as the displayed screen or window from the
Access 2 system software.
The system provides the following reports:
• Alignment Report
• Calibration Reports
• Continuous Sample Report
• Derived Results Setup Report
• Event Log Report
• Incubator Belt Calibration Report
• Level Sense Report
• Patient Report
• QC Reports
• Ranges Reports (Reference, Critical, and LIS Ranges)
• Reagent Inventory Report
• Reflex Tests Setup Report
• Sample Report
• Selected Test Results Report
• Supplies Required Report
• System Check Report
• Temperature Report
• Test Panels Setup Report
• Tests Setup Report
• Work Pending Report
The first page of every report contains a complete header, and subsequent pages of the
report contain an abbreviated header.
NOTE
If information about a sample or a patient continues onto another page, the system
repeats the sample or patient ID at the top of that page.
For more information about setting up report header information, see Section 4.2:
System Setup in the Reference Manual.
4 5
3 Laboratories, Inc.
6
Laboratory A
Report Name
123 Lake Street
Townsville, ST 3333 7
Access 2 Immunoassay System 101-555-2323 ext. 109 8
S/N 501240 Jane Smith
2
1 9
10
QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range,
LEX = reagent pack lot expired 11
13 12
Page 1 of 1
Technologist Printed 10-10-00 2:43pm
0745B.eps
1 Instrument Serial Number (S/N) (if Report Type is Specific to One Instrument)
2 Product Name (Access 2 Immunoassay System)
3 Report Title
4 Institution
5 Laboratory Name
6 Laboratory Street Address
2 Supplies
2.1 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.1 Supplies
Access 2 system supplies are the consumables and waste containers that you must
change to continue operating the system. Consumables consist of wash buffer,
substrate, reaction vessels (RVs), and reagent packs. Waste containers consist of the
liquid waste bottle and the RV waste bag.
The system keeps track of the following supply status information during processing:
• When the wash buffer reservoir is empty
• When the liquid waste bottle is full
• When the substrate bottle was opened, when it will expire, and how many
tests can be processed with the current supply
• How many RVs are available
• How many RVs will fit in the RV waste bag
• Which reagent packs are on board and off board, number of days the pack has
been open, the pack expiration date (the earlier of two dates: the lot
expiration date printed on the label or the open pack expiration date), how
many tests can be processed with the current supply in each pack, and which
packs are in use.
• When each calibration will expire
• Which reagent packs are in inventory for all instruments in a workgroup
The system displays and continuously updates supply status information during
processing.
For information about ordering supplies, see the Instructions for Use.
Supply Status
System status buttons are located at the top of every Access 2 system screen. These
buttons alert you to the status of onboard supplies and waste containers. If a supply
level requires your attention, the status button changes color. When a button changes
color, you can select it to access the screen or window you use to get detailed supply
information, to load the supply, or to change the waste container.
For more information about the system status buttons, see Section 1.3: Software
Overview.
NOTE
You do not use the system screens, windows, or function buttons when you
change the wash buffer or liquid waste bottles. You do need to use the system
screens, windows, or function buttons according to the procedures, when you
change the substrate or RV waste bag, or load reaction vessels (RVs) or reagent
packs.
Manually Your instrument is equipped with an external handheld bar code reader or an external
Scanning Bar bar code wand. For some Access 2 systems the handheld bar code reader also operates
Codes in a hands-free mode. Use the external bar code reader to enter information provided
on the following types of bar codes:
• Access substrate bar code label
• Access calibrator card bar codes
• Reagent pack bar code labels
• Sample container bar code labels
• Sample rack bar code labels
Use these procedures to scan a bar code with the bar code reader that you have.
1. Be sure that the cursor is positioned in the appropriate field of the window or
screen before scanning the bar code.
2. Locate the handheld bar code reader. If the reader is stored in a housing, remove
it before you scan bar code information in the handheld mode.
3. Aim the bar code reader at the bar code label. Hold the reader approximately
1 to 8 inches (2.5 to 20.3 cm) from the label.
4. Squeeze the trigger and center the red light (indicating the scanning area) within
the vertical lines of the bar code. Adjust the reader distance to extend the light just
beyond the length of the bar code, on both ends.
5. When the system beeps (and for some readers, a green dot is displayed on the bar
code), release the trigger.
6. Look at the window or screen and verify that the bar code information is correctly
displayed in the appropriate field.
• If the information is not correct and the bar code is not damaged in any way,
select Cancel F8 and scan the bar code again.
• If the information is not correct and the bar code is damaged, delete the
information in the Bar Code field and type the bar code characters printed
underneath the bar code.
8. If the handheld reader is stored in a housing, return the reader to its housing when
you finish scanning the bar code label information.
2. Locate the bar code reader. The reader should be stored in the housing that is
mounted on the tray supporting the system keyboard.
NOTE
Do not scan sample container or sample rack bar code information when the
reader is operating in the hands-free mode.
3. The bar code reader emits a green circle of light. Move the calibrator card or bar
code label underneath the reader until it meets the circle.
The green circle changes to a horizontal red line (indicating the scanning area) when
the reader detects the calibrator card or bar code label.
4. Continue moving the card or label until the vertical lines of the bar code intersect
the horizontal red light.
The reader beeps and the sides flash green when it successfully scans the bar code.
5. After the reader scans the bar code, look at the window or screen and verify that
the bar code information is correctly displayed in the appropriate field.
• If the information is not correct and the bar code is not damaged in any way,
select Cancel F8 and scan the bar code again.
• If the information is not correct and the bar code is damaged, delete the
information in the Bar Code field and type the bar code characters printed
underneath the bar code.
1. Be sure that the cursor is positioned in the appropriate field of the window or
screen before scanning the bar code.
2. Place the tip of the wand at an angle on the quiet zone of the bar code. For more
information, see Section 2.3: Performance Characteristics in the Reference
Manual. When the wand is properly angled, you will see a small, oval pattern of
light extending from the tip of the wand within the quiet zone.
3. Move the tip of the wand smoothly and rapidly across the bar code to the quiet
zone on the other side. The system beeps after it successfully reads the bar code.
NOTE
Keep the light focused within the lines of the bar code. If the light extends across
the edge of either side of the bar code, the bar code may not be read successfully.
4. Look at the window or screen and verify that the bar code information is correctly
displayed in the appropriate field.
• If the information is not correct and the bar code is not damaged in any way,
select Cancel F8 and scan the bar code again.
• If the information is not correct and the bar code is damaged, delete the
information in the Bar Code field and type the bar code characters printed
underneath the bar code.
To get to this screen from the Main Menu, select Supplies F3, or from any screen,
select the Substrate, RVs, or RV Waste Bag button.
0631E.bmp
Figure 2-1 Supplies Screen
Reagent Pack (24 Buttons) Correspond to the 24 available slots in the reagent carousel of the
Button instrument. The buttons are sorted alphabetically by reagent pack name. The reagent
pack button turns red and the reagent pack name is displayed in white when a pack is
rejected during reagent pack monitoring.
For each onboard reagent pack, the button displays the following information:
• Reagent Pack Name – (Button label) Displays the reagent pack name, which is
the same as the test name, except in the case of multi-constituent tests, such as
Folate and RBC Folate. The RBC Folate test uses the Folate reagent pack, so there
is no Reagent Pack button for RBC Folate.
NOTE
If ???? displays on the Reagent Pack Name label and in the Lot Number field,
the instrument was unable to read the reagent pack bar code. For more
information, see the Loading a Reagent Pack procedure.
• Tests Left – (Field) Displays the number of tests remaining in the pack, updated as
the system uses the reagent. If the pack expiration date is within three days, the
number of hours remaining is shown in parentheses * This field turns yellow when
there are 10 tests or fewer remaining for all onboard packs with the same lot
number, or if the open pack expiration date is within three days. The field turns red
when there are zero tests left, or the pack is past the open pack expiration date.
• Lot Number – (Field) Displays the lot number of the reagent pack. If the
calibration for the lot will expire within three days, the number of hours remaining
is shown in parentheses.* This field turns yellow when the pack lot or the
calibration for the lot will expire within three days. The field turns red when the
calibration for the lot is expired or if no calibration exists.
NOTES
• For assay calibrations that expire within three days of being generated, the
field does not turn yellow. The field goes straight to red when the calibration
is expired.
• The system tracks both pack lot and open pack expiration dates.
• In-Use Icon– (Padlock Icon) Displays when the system is processing samples and
the reagent pack is scheduled for use.
The system updates the Reagent Pack buttons when you load and unload packs.
*Access 2 software version 3.6.0 and higher.
RV Supply (Field) Displays the number of RVs available. The system updates this number as it
uses RVs.
This field turns yellow when there are 60 or fewer RVs available. This field turns red
when there are 28 or fewer RVs available.
RV Waste (Field) Displays the number of RVs that can fit in the waste bag. The system updates
this number as it ejects RVs.
This field turns yellow when there is room for 60 or fewer RVs in the waste bag. The
field turns red when the waste bag is full.
Substrate • Substrate – (Field) Displays the number of tests the system can process with the
current substrate supply. This field turns yellow when the system can process 60 or
fewer tests. The field turns red when the substrate bottle is empty. The system
updates this number as it uses substrate.
• Lot Number – (Field) Displays the lot number of the substrate. This field turns
yellow when the lot will expire within three days. This field turns red when the lot
expires.
• Days Until Expiration – (Field) Displays the number of days until the substrate
expires, based on when the bottle was opened. This field turns yellow when the
substrate will expire within three days. This field turns red when the substrate
expires.
Load Reagent (Button) Select to display the Load Reagent Pack window.
Pack F1 For more information about loading reagent packs, see Section 2.7: Reagent Packs.
Unload Reagent (Button) Select to unload a reagent pack.
Pack F2 For more information about unloading reagent packs, see Section 2.7: Reagent Packs.
Remap F3 (Button) Select to remap the reagent inventory. For more information see Remapping
Packs on page 2-43.
Load RVs F4 (Button) Select to load RVs.
For more information about loading RVs, see Section 2.5: Reaction Vessels (RVs).
Change (Button) Select to change the substrate bottle.
Substrate F5 For more information about changing substrate, see Section 2.4: Substrate.
Change RV (Button) Select to change the RV waste bag.
Waste Bag F6 For more information about changing the RV Waste Bag, see Section 2.6: Reaction
Vessel Waste Bag.
Reagent (Button) Select to display the Reagent Inventory screen.
Inventory F7 For more information about the Reagent Inventory screen, see Section 2.8: Reagent
Inventory.
WARNING
Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water. Wear
suitable gloves.
Wash buffer is buffered solution the Access 2 system uses to clean the main pipettor
and probes, and to remove unbound material during test processing. The system
monitors the volume of onboard wash buffer with a float level sensor.
You can change the wash buffer bottle at any time. Because of the internal reservoir,
the system continues processing samples even when you remove the wash buffer
bottle.
For information about ordering supplies, see the Instructions for Use.
Changing the
Wash Buffer
Gently invert new
Bottle wash buffer bottle
3 or 4 times
Remove dispense
cap assembly from
empty bottle
0588B.wmf
Figure 2-3 Changing the Wash Buffer Bottle
WARNING
Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water. Wear
suitable gloves.
1. Mix the contents of the new wash buffer bottle by gently inverting the sealed
bottle 3 or 4 times.
2. Remove the cap and the inner seal from the new bottle.
3. Lift the empty bottle from the reservoir in the fluids tray on the left side of the
instrument (see Figure 2-4).
CAUTION
To avoid contaminating the wash buffer, do not touch any part of the
dispense cap assembly that enters the reservoir. Handle the dispense cap
assembly only by screw cap, not the nozzle.
4. Unscrew the wash buffer dispense cap assembly from the empty bottle.
6. Turn the new bottle upside down and place the dispense cap assembly into the
reservoir receptacle.
NOTES
• The wash buffer flows into the wash buffer reservoir as needed. DO NOT
squeeze the bottle. Squeezing the bottle may force excess buffer into the
reservoir and cause the reservoir to overflow.
• The sides of the bottle may cave in as the wash buffer drains. This is normal.
1061Aeps
WARNING
Consider the liquid waste potentially infectious. Handle and dispose of the liquid
waste according to proper laboratory procedures. Proper hand, eye, and facial
protection is required.
The liquid waste bottle collects liquid waste. Each instrument ships with two waste
bottles. With two waste bottles, you can cycle containers, with one installed on the
instrument while you decontaminate the other. For your convenience, you can order
more waste bottle assemblies.
NOTE
The liquid waste drain kit may be used instead of the waste bottle. The drain kit
directs liquid waste to a floor drain. Because site conditions vary,
Beckman Coulter requires that you consult with Technical Support to determine
whether your system can be fitted with the kit.
The system uses a weight sensor to monitor the volume in the onboard liquid waste
bottle.
The Liquid Waste button turns red when the waste Liquid Waste Button
bottle is full. The system will not schedule any new
tests until you change the liquid waste bottle. You can
change the liquid waste bottle at any time, even during
sample processing, but preferably before the bottle is
full. The Liquid Waste button does not turn yellow.
0574A.bmp
For information about ordering supplies, see the Instructions for Use.
Changing the
Liquid Waste
Bottle
Loosen cap of full
liquid waste bottle
Stopped
Remove bottle cap and
Processing No insert in clean bottle
samples?
Yes
Connect quick
disconnects to empty
liquid waste bottle
Decontaminate
contents of full liquid
waste bottle
0589C.wmf
Figure 2-5 Changing the Liquid Waste Bottle
Use this procedure to change the liquid waste bottle. To minimize contact with liquid
waste, do not change the liquid waste bottle while the system is processing samples.
The fluids tray containing the liquid waste bottle has two configurations, see
Figure 2-6. The connections to the liquid waste bottle are similar.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazardous materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1. Loosen the liquid waste bottle cap slightly to release any pressure that is inside
the bottle.
2. If the system is not processing samples, press the button on the quick disconnects
while pulling on the tubing to detach the tubing from the liquid waste bottle cap
(see Figure 2-6). Immediately, connect the quick disconnects to the cap of a clean
liquid waste bottle.
(Optional) If the system is processing samples, remove the liquid waste bottle cap
and immediately attach it to a clean liquid waste bottle.
NOTE
If a clean liquid waste bottle is not immediately available, put the liquid waste
bottle cap into a temporary container to prevent spills.
3. Remove the full liquid waste bottle and place the clean liquid waste bottle in the
fluids tray.
4. Decontaminate the contents of the full liquid waste bottle according to proper
laboratory procedures before disposing of the liquid waste.
6. Rinse the just-emptied liquid waste bottle thoroughly by filling it with tap water
and discarding the contents to remove any traces of the decontaminant.
WARNING
Thoroughly flush any decontaminant from the liquid waste bottle before you
store the liquid waste bottle. If you reinstall the liquid waste bottle before you
flush it, any remaining decontaminants may react with chemicals pumped into
the liquid waste bottle and the resulting chemical reactions can create gases
harmful to you or the instrument.
1062A.eps
2.4 Substrate
When the system can process 60 or fewer tests with the Substrate Button
current supply of substrate, the Substrate button turns
yellow. When the substrate bottle is empty the button turns
red, and the system cannot start processing samples until
you connect a new bottle of substrate. You can only change
the substrate bottle while the system is in the Ready mode.
0575Ac.bmp
The fluids tray can accommodate two or three substrate bottles (depending on the
fluids tray configuration). The bottle in use is connected to the substrate tubing. The
additional bottle or bottles can be stored in the tray to equilibrate the substrate to room
temperature prior to use. The time required for equilibration is specified in the
substrate reagent instructions for use.
All Access substrate bottles have a bar code label. The Access 2 system tracks the lot
number, expiration date, serial number, and the number of tests remaining in the open
substrate bottle. The system also checks the substrate quantity and expiration date
prior to sample processing, and notifies you if supplies are required. You can override
an expired supply condition, but any test results generated with expired substrate are
flagged.
For more information about checking and overriding supply conditions, see
Section 4.2: Supply and Calibration Conditions.
Changing the
Substrate
Bottle any screen
Supplies
Change Substrate
F5
Change Substrate
Done
F1
Yes
F1
0505B.wmf
Figure 2-7 Changing the Substrate Bottle
CAUTION
Do not combine partial bottles of substrate.
2. Go to the Supplies screen. To get to this screen from any screen, select the
Substrate button.
0662A.bmp
Figure 2-8 Change Substrate Window
Bar Code (Field) Using either the external bar code reader or the
keyboard, enter the bar code ID of the substrate bottle.
Lot Number (Field) Displays the lot number of the substrate bottle.
Serial Number (Field) Displays the unique serial number of the substrate
bottle.
Expiration Date (Field) Displays the expiration date of the substrate bottle.
Tests Left (Field) Displays the number of tests that can be run using
the substrate bottle.
4. Pick up the equilibrated (new) substrate bottle and enter the bar code information
by scanning the bar code label on the bottle with the external bar code reader or
by typing the characters in the Bar Code field on the Change Substrate window
(see Figure 2-8).
The window displays the lot number, serial number, expiration date, and number of
tests left for the new substrate bottle (see Figure 2-8). The system retains the
substrate information and warns you if you try to load an expired bottle.
NOTES
• To avoid contaminating the substrate, touch the tubing or the inside of the
substrate cap only with a clean, lint-free tissue. Do not allow the substrate
tubing to contact any surface.
• Never combine partial bottles of substrate. Combining partial bottles causes
incorrect monitoring of the substrate supply, and may contaminate the
substrate system.
For information on scanning the bar code, see the Manually Scanning Bar Codes
procedure in Section 2.1: Supplies.
5. Remove the cap from the new, equilibrated substrate bottle and discard the cap
(see Figure 2-10).
1063A.eps
6. Unscrew the substrate supply cap from the bottle in use and immediately screw it
onto the new bottle.
7. Determine the configuration of your substrate supply cap assembly(see
Figure 2-11).
1 2
1058A.eps
8. If your substrate supply cap does NOT have a fitting lock, confirm that the
fittings on the substrate supply cap are finger-tight (see Figure 2-12).
1059A.eps
Figure 2-12 Finger Tighten Substrate Supply Cap Fittings
The system updates the substrate information on the Supplies screen and displays a
message about priming the substrate.
12. Remove the empty substrate bottle from the fluids tray and discard the bottle.
13. Place an unopened bottle of substrate in the fluids tray to allow the substrate to
equilibrate to room temperature.
NOTE
Do not store substrate at room temperature for longer than the limits specified in
the reagent instructions for use. Do not loosen or remove the cap on the substrate
bottle while it is equilibrating.
During an Access 2 test, the chemical reaction occurs in a container called a reaction
vessel (RV). Each test uses one or two RVs. RVs come in cartridges of 98. You can
load up to 3 cartridges at a time for a maximum capacity of 294 RVs. The system
monitors the number of RVs onboard the instrument.
Loading RVs
any screen
Supplies
Load RVs
F4
Load RVs
Remove cartridge
cover, load cartridge,
remove empty spine
Done
F1
0504A.wmf
Figure 2-13 Loading RVs
NOTES
• You can load only full cartridges of RVs. If you try to load RVs when the
instrument has room for only a partial cartridge, the system displays a
message.
• If the system is processing samples and has one row or fewer RVs left when
you try to load more, the system displays a message. You must wait until the
instrument stops before you load the new cartridge.
• RVs can fall between the rake and the wall of the incubator if you do not load
RVs properly by selecting Load RVs F4 from the Supplies or Supplies
Required screen.
1. Go to the Supplies screen. To get to this screen from any screen, select the RVs
button.
3. Peel back and remove the protective covering from the RV cartridge.
4. To be sure that all 98 RVs are firmly seated in the cartridge spine, press down on
the spine before you load the cartridge.
5. Open the supplies door on the front of the instrument (see Figure 2-14).
0013A.eps
1 Supplies Door
2 RV Load Door
8. To release the RVs, press down firmly on the RV load door until it snaps closed.
9. Open the RV load door and remove the empty spine. Do not leave the RV load
door open longer than necessary when the system is processing.
CAUTION
Remove the empty cartridge spine to prevent possible damage to the RV
rake.
The RV rake moves forward to hold the RVs in position and the system updates the
Supplies screen with the current RV inventory.
When a test is complete, the instrument ejects the reaction vessel (RV) through the
waste chute into the RV waste bag. The RV waste bag holds up to 300 RVs. The
system monitors the number of RVs ejected into the waste bag, and warns you when
the waste bag is nearing capacity.
When the waste bag has room for 60 or fewer RVs, the RV Waste Bag Button
RV Waste Bag button turns yellow. When the RV
waste bag is full, the button turns red and the system
will not start processing samples. You must change the
RV waste bag.
0577A.bmp
When you install a new RV waste bag, the system resets the RV counter.
For more information about how RVs move through the system, see Section 3.1:
Sample Processing Theory in the Reference Manual.
Changing the
RV Waste Bag
any screen
Supplies
Done
F1
0507A.wmf
Figure 2-15 Changing the RV Waste Bag
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• The system will not start sample processing without a waste bag in place.
• Always use the Change RV Waste Bag window to change the waste bag to
ensure that the system can correctly monitor the capacity of the RV waste
bag.
1. Go to the Supplies screen. To get to this screen from any screen, select the RV
Waste Bag button.
4. Unfold a new waste bag, grasp its sides, and pull gently to expand it.
NOTE
If the instrument is ejecting RVs, wait until you hear an RV ejected. You then
have 36 seconds to remove the old waste bag and install the new one before the
instrument ejects the next RV.
CAUTION
If the system is in the Running mode when you change the RV waste bag, the
system may try to eject an RV when the plastic collar on the waste bag is
blocking the ejection chute. This will cause a jam.
6. Place the new bag into position by sliding the plastic collar on the bag into the
slot on the waste chute. Press down firmly to be sure that the collar is completely
seated.
The system confirms that a new waste bag is inserted before enabling the Done F1
button.
NOTE
If the next RV in line sticks out from the ejection chute slightly, it may prevent
the plastic collar on the new waste bag from sliding into the slot on the waste
chute. Gently push the top of the RV back slightly and out of the way of the
plastic collar.
CAUTION
To prevent damaging the system, DO NOT push an RV that is sticking out
from the ejection chute all the way back into the chute.
The instrument holds up to 24 reagent packs. The Access 2 system monitors the
number of tests processed using each reagent pack.
When an onboard reagent pack does not contain Supplies Required Button
enough reagent to process requested tests, the
system assigns those tests the Supply Wait
status and the Supplies Required button turns
yellow.
0578A.bmp
When you load a new pack onto the instrument, the system takes the requested tests
out of Supply Wait status and begins processing them.
When an onboard reagent pack fails reagent pack monitoring, the test in process is
canceled and the reagent pack is rejected and cannot be used for further processing.
Unload and discard the pack. For more information about reagent pack monitoring,
see Section 1.3: Assay Technology in the Reference Manual.
For reagent packs in inventory, the Access 2 system also tracks the lot expiration date
and the number of days the pack has been open.
For more information about sample processing and supplies required, see
Section 4.1: Sample Processing.
Loading a
Reagent Pack You can load a reagent pack from
the Supplies Required screen Or from the Main Menu
Supplies
F3
You can also load a
Supplies Required Supplies reagent pack from the
Reagent Inventory screen
IRBR**
present and No
enabled?
Yes
Manually scan
reagent pack
Load another
pack?
No
Yes
Next Done
F2 F1
0502Ea.wmf
Figure 2-16 Loading a Reagent Pack
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• If you are reloading a partially used reagent pack, it must be returned to the
same stand-alone system or Access 2 workgroup from which it was removed.
If a partially used reagent pack is loaded on a different system or
workgroup, it will be inventoried as a full pack and inaccurate results may
occur.
NOTES
• If you try to load an empty reagent pack, the system displays a message and
prevents you from loading the pack.
• If you load an expired reagent pack, the system displays a message.You can
use the pack only if you override the expired condition. For information
about using expired reagent packs, see the Overriding Supply Conditions
procedure in Section 4.2: Supply and Calibration Conditions.
• You must always use the Load Reagent Pack window to load a reagent pack
to be sure the system can monitor the location of and tests left in the reagent
pack.
0663B.bmp
Figure 2-17 Load Reagent Pack Window
Serial Number (Field) Displays the unique serial number of the reagent
pack.
Expiration Date (Field) Displays the expiration date of the reagent pack.
Tests Left (Field) Displays the number of tests that can be run using
the reagent pack.
Done F1 (Button) Select when you are finished loading the reagent
pack or packs.
When manually entering reagent pack bar code
information, you select Done F1 after you enter the bar
code information and load EACH reagent pack.
When using the internal reagent bar code reader (available
on instruments with serial numbers 570000), you select
Done F1 after you have placed ALL the reagent packs
onboard the instrument.
Next F2 (Button) Select to load another reagent pack when using
the internal bar code reader.
Available only on instruments with an internal bar code
reader and when the bar code reader is enabled.
When you load a reagent pack, you can enter the reagent pack bar code information in
one of three ways:
• Using an external bar code reader to scan the bar code label.
• Using the keyboard to enter the characters above the reagent pack bar code in the
Bar Code field on the Load Reagent Pack window.
• Using the internal reagent bar code reader (if available and if enabled).
2. Select Load Reagent Pack F1 to display the Load Reagent Pack window.
NOTE
You must always use the Load Reagent Pack window to load a reagent pack to be
sure the system can monitor the location of and tests left in the reagent pack.
3. Invert the unpunctured pack several times immediately before loading the pack.
This dislodges any particles from the underside of the seal on the reagent pack. It
is not necessary to remix packs after loading. Do not invert a punctured pack.
NOTE
Do not shake packs or use a vortex mixer, except for the Access 25(OH)
Vitamin D Total assay. For the Access 25(OH) Vitamin D Total assay, see the
reagent IFU for pack mixing instructions.
6. Insert the reagent pack into the empty slot directly under the reagent carousel
door.
a. Lower the pack into position by angling the narrow end of the pack down
into the slot and gently pressing forward on the pack (see Figure 2-19).
b. Press down on the back of the pack until the pack snaps into place, then
gently pull the pack back toward the outer rim of the reagent carousel.
A spring on the front of the pack and a small plastic anchor on the back of the pack
hold the pack securely in place.
CAUTION
To prevent damaging the reagent pack, be sure it is properly seated in the
reagent carousel.
7. To load additional reagent packs, select Next F2. The carousel will move an
empty slot into position under the reagent carousel door (see Figure 2-19). Allow
the carousel to come to a complete stop, and then insert the reagent pack into the
slot.
8. Close the reagent carousel door.
The system scans the reagent packs using the internal reagent pack bar code reader
and loads the packs. When the instrument accepts the reagent packs, the buttons for
the reagent packs are displayed on the Supplies screen.
If the internal reagent pack bar code reader is unable to read the bar code, or if a bar
code reader failure occurs, an event log message is created and the Supplies screen
displays a reagent pack button with ???? in the Reagent Pack Name and Lot Number
fields. You must unload all packs with ???? in the Reagent Pack Name and Lot Number
fields, and then load them by manually entering the bar code information. For more
information, see the Unloading a Reagent Pack procedure and see the Loading a
Reagent Pack and Manually Entering Bar Code Information procedure.
For more information on scanning the bar code, including information on how to use
other handheld bar code readers, see the Manually Scanning Bar Codes procedure in
Section 2.1: Supplies.
1. Go to the Supplies screen. To get to this screen from the Main Menu, select
Supplies F3.
2. Select Load Reagent Pack F1 to display the Load Reagent Pack window.
NOTE
You must always use the Load Reagent Pack window to load a reagent pack to be
sure the system can monitor the location of and tests left in the reagent pack.
3. Invert the unpunctured pack several times immediately before loading the pack.
This dislodges any particles from the underside of the seal on the reagent pack. It
is not necessary to remix packs after loading. Do not invert a punctured pack.
NOTE
Do not shake packs or use a vortex mixer, except for the Access 25(OH)
Vitamin D Total assay. For the Access 25(OH) Vitamin D Total assay, see the
reagent IFU for pack mixing instructions.
6. Insert the reagent pack into the empty slot directly under the reagent carousel
door.
a. Lower the pack into position by angling the narrow end of the pack down
into the slot and gently pressing forward on the pack (see Figure 2-19).
b. Press down on the back of the pack until the pack snaps into place, then
gently pull the pack back toward the outer rim of the reagent carousel.
A spring on the front of the pack and a small plastic anchor on the back of the pack
hold the pack securely in place.
2
1
4
5
0764B.eps
CAUTION
To prevent damaging the reagent pack, be sure it is properly seated in the
reagent carousel.
7. Manually enter the reagent pack bar code by scanning the reagent pack with the
external bar code reader (see Figure 2-20) or by typing the characters located
above the reagent pack bar code into the Bar Code field.
The system displays the information from the reagent pack bar code in the Load
Reagent Pack window.
a
b
E
tal Ig
To
c
6D
3F
8T
WM
d
e
0019F.eps
Figure 2-20 Scanning a Reagent Pack Bar Code with the Bar Code Wand
The Supplies screen displays a button for that reagent pack in the list of onboard
reagent packs.
Unloading a
Reagent Pack Main Menu
Supplies
F3
Done
F1
Done
F1
0503A.wmf - v1.7
Figure 2-21 Unloading a Reagent Pack
NOTES
• If the system is using a reagent pack to process tests, you cannot unload it
(identified by the in-use [padlock] icon on the Supplies screen).
• When you unload a partially full reagent pack, the system keeps track of the
number of tests left in the pack until you reload it or manually delete it from
inventory.
• Immediately unload any reagent packs that are empty or are rejected as a
result of reagent pack monitoring.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1. Go to the Supplies screen. To get to this screen from the Main Menu, select
Supplies F3.
2. Using the touch screen or the mouse, select the button for the reagent pack you
want to unload.
NOTE
The Supplies screen does not recognize selections made with the arrow keys on
the keyboard. If you use the arrow keys to select a reagent pack, a different
reagent pack may be displayed in the Unload Reagent Pack window and
presented for unloading.
NOTE
Even if the reagent pack you want to unload is already in the unloading position
in the reagent carousel, you must use the Unload Reagent Pack window to unload
the pack to be sure the system can properly monitor the reagent inventory.
6. Remove the reagent pack from the slot directly under the reagent carousel door.
a. Press forward gently as you lift the back of the reagent pack.
b. Slide the pack back slightly to release the spring on the front of the pack
before completely removing the pack from the carousel.
10. If the unloaded reagent pack is empty or was rejected as a result of reagent pack
monitoring, discard it as biohazardous waste.
The system automatically deletes the pack from the database.
11. If you intend to use the unloaded pack again, store it upright in the refrigerator.
Use the pack before it expires.
Retrieving For the Access 2 system to accurately track the proper locations of reagent packs on
Misplaced the reagent carousel, the packs must be loaded and unloaded using the appropriate
Packs system windows. If you load a pack and do not use the Load Reagent Pack window,
or if you use the Unload Reagent Pack window, but do not remove the pack, you will
have a misplaced pack on your system.
Use this procedure to retrieve a misplaced reagent pack.
NOTE
If your system is equipped with an internal reagent bar code reader, you can use
the Remap feature to automatically identify misplaced packs and add them to the
reagent inventory. For more information, see Remapping Packs on page 2-43.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
3. Go to the Device Diagnostics screen. To get to this screen from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Device
Diagnostics F4.
6. Slide the carousel door to the left to open it, and then open the reagent carousel
door.
7. Gently turn the reagent carousel one rotation. If you find any reagent packs
remaining on the carousel, remove them as they come into position at the reagent
carousel door.
8. After verifying that all packs are removed, close the reagent carousel door and
then slide the carousel door to the right to close it.
For more information, see the Homing a Device procedure in Section 5.5: Mechanics
and Device Diagnostics of the Reference Manual.
For more information, see Section 5.2: Initialize System of the Reference Manual.
12. When system initialization is complete, reload all of the packs you removed from
the reagent carousel.
For more information, see the Loading a Reagent Pack procedure.
Remapping On systems equipped with an internal reagent bar code reader (instruments with serial
Packs numbers 570000), you can perform a Remap operation to scan for bar codes in all
slots to identify loaded packs.
Packs that were originally manually loaded due to an unreadable bar code may not be
identified by this remap and will be assumed to still be loaded.
NOTE
If the Remap F3 button is unavailable, check the bar code reader configuration to
ensure that the internal reagent bar code reader is enabled. For more information,
see Section 4.3: Bar Code Reader Setup in the Reference Manual.
The Access 2 system keeps an inventory of all onboard and off-board reagent packs
for every instrument in the workgroup. When you load a reagent pack, you enter the
bar code information manually or by using the internal reagent bar code reader. The
bar code label contains the following information:
• Pack name
• Lot number
• Serial number
• Lot expiration date
The system also tracks the following information (not on the bar code label) for each
pack:
• Tests left
• Number of days the pack has been open (and the open pack expiration date)
• Pack expiration date (the earlier of two dates: the lot expiration date printed
on the label and the open pack expiration date)
• Calibration expiration date (for assays that are calibrated)
• Slot number (for packs onboard the instrument the PC is attached to)
• Instrument the pack is on (for packs onboard an instrument in the workgroup)
You can remove a reagent pack from the instrument, store it, and reload it when
needed.
To maintain the reagent pack inventory, the system automatically deletes empty packs
when you unload them. You can manually delete full or partially full packs, if
necessary.
NOTE
You cannot reload a reagent pack after you have deleted it.
For more information about how to delete reagent packs, see the Deleting a Reagent
Pack procedure.
For information on scanning the bar code, see the Manually Scanning Bar Codes
procedure in Section 2.1: Supplies.
For information about how to load and unload reagent packs, see Section 2.7: Reagent
Packs.
For detailed information about open pack stability and expiration, see the reagent
instructions for use.
You access the Reagent Inventory screen from the Supplies screen.
0587D.bmp
Figure 2-22 Reagent Inventory Screen
Open Slots (Field) Displays the number of empty reagent pack positions on the reagent carousel.
The number of open slots only applies to the instrument the PC is attached to.
Entries (Field) Displays the number of reagent packs that meet the current filter parameters.
Test Name (Column) Displays the test names. The entry in this column turns red when the
reagent pack is rejected as a result of reagent pack monitoring.
The system updates the screen continuously as you load and unload reagent packs.
Each pack is identified by a unique serial number.
If a pack is used for more than one test, the system displays the primary and
secondary tests for that pack. For example, the Folate pack is used to run a primary
test (Folate) and a secondary test (RBC Folate). The system displays both of the tests,
primary and secondary, under the primary test (Folate). When sorted, the primary and
secondary tests stay together.
Lot No. (Column) Displays the reagent pack lot numbers.
You can load multiple reagent packs with the same lot number on the instrument at
one time.
Serial No. (Column) Displays the unique reagent pack serial numbers.
The system uses this number to track inventory information for the reagent pack.
Tests Left (Column) Displays the number of tests the system can process using each reagent
pack. The field in this column turns yellow when there are 10 tests or fewer remaining
for all onboard packs with the same lot number, or if the open pack expiration date is
within three days. The field in this column turns red when there are zero tests left, or
the pack is past the open pack expiration date.
NOTE: To refresh the information displayed in this column, you must exit the screen
and redisplay it.
Days Open (Column) Displays the number of days since the system first punctured the reagent
packs.
Pack Expiration (Column) Displays the dates the reagent packs expire.
The pack expiration date is the lot expiration date or the open pack expiration date,
whichever is earliest.
For a specific reagent pack, the entry in this column turns yellow when the reagent
pack expires within three days. The entry turns red when the reagent pack is expired.
To calculate the open pack expiration, the system records the date the primary probe
first punctures the reagent pack and adds a number of days past that date, based on
limits specified in the assay protocol file (APF).
Calib. Expiration (Column) Displays the expiration dates of the current assay calibrations.
• For onboard packs with more than one calibration, the expiration date of the active
calibration is displayed.
• For onboard packs with no established calibration, the value None is displayed.
• For packs that are not onboard the instrument, the value Unloaded is displayed.
For a specific reagent pack, the entry in this column turns yellow when the calibration
expires within three days. The entry turns red when the calibration is expired.Assay
calibrations can be completed while you are reviewing this screen. To refresh the
information displayed in this column, exit the screen and redisplay it.
For more information about calibrations, see Chapter 6: Assay Calibrations.
Slot (Column) Displays the position of reagent packs on the reagent carousel. Slot
positions are from 1 to 24.
If the pack is not onboard the instrument, the entry is blank.
Instrument (Column) Displays the instrument the reagent pack is loaded on.
If the pack is not onboard the instrument, the entry is blank.
Load Reagent (Button) Select to load a reagent pack. When the instrument presents an empty pack
Pack F1 position on the reagent carousel, you can load a reagent pack.
For more information on loading a reagent pack, see the Loading a Reagent Pack
procedure in Section 2.7: Reagent Packs.
Unload Reagent (Button) Select to unload the selected reagent pack. When the instrument presents the
Pack F2 reagent pack, you can unload it from the reagent carousel.
This button is unavailable if the selected pack is not onboard the instrument, or if the
pack is onboard another instrument in the workgroup.
For more information on unloading a reagent pack, see the Unloading a Reagent Pack
procedure in Section 2.7: Reagent Packs.
Remap F3 (Button) Select to remap the reagent inventory. For more information, see Remapping
Packs on page 2-43.
Delete Pack F5 (Button) Select to delete a reagent pack that is not onboard the instrument.
NOTE: You cannot reload a reagent pack after you have deleted it.
This button is unavailable if the selected pack is onboard an instrument.
For more information on deleting a reagent pack, see the Deleting a Reagent Pack
procedure in this section.
Print F7 (Button) Select to print the Reagent Inventory Report for all reagent packs in the
current filter.
Filter F8 (Button) Select to choose filter parameters, sort order, and instruments to include on
the Reagent Inventory screen.
For more information on using a filter, see the Applying a Filter to the Reagent
Inventory Screen procedure in this section.
Applying a Fil- A filter is a set of parameters you can change to increase or decrease the number of
ter to the reagent packs that display on the Reagent Inventory screen. A filter is always applied.
Reagent The default filter at system installation is all packs sorted by pack name on the
instrument the PC is attached to. Use this procedure to apply a different filter to the
Inventory
Reagent Inventory screen.
Screen
NOTE
The system uses the selected filter until you apply a different one.
1. Go to the Reagent Inventory screen. To get to this window from any screen,
select the Substrate, RVs, or RV Waste Bag button to display the Supplies
screen, then select Reagent Inventory F7.
Select Filter F8 to display the Filter window.
Filter (List) Select a filter that limits the packs that display on
the Reagent Inventory screen.
Sort Order (Options) Select to change the default sort order of the
packs.
Values are: Pack Name, Tests Left, Days Open, Pack
Expiration, Carousel Slot, and Instrument.
Ascending (Box) Displays the default sort order of the packs. Select
to sort the packs in the ascending order and clear to sort
in descending order.
The system sorts the packs in the following order:
• Pack Name and Instrument are sorted
alphanumerically
• Tests Left, Days Open, and Carousel Slot are sorted
numerically
• Pack Expiration is sorted by date
NOTE
If you select the All Packs filter, the Carousel Slot option is not available.
6. Select OK F1.
The Reagent Inventory screen displays the reagent packs according to the filter
criteria, sort order, and instruments you selected.
Deleting a
Reagent Pack
Main Menu
Supplies
F3
Supplies
Reagent Inventory
F7
Reagent Inventory
Yes
Delete Pack
F5
0508A.wmf
Figure 2-26 Deleting a Reagent Pack
Use this procedure to delete full or partially full off-board reagent packs from
inventory.When you delete a reagent pack, the system removes pack information
from screens and reports, but keeps it in the database.
NOTES
• You cannot reload a reagent pack after you have deleted it.
• You cannot unload or delete a reagent pack that is in use.
• You must unload a reagent pack before you can delete it.
• The system automatically deletes an empty reagent pack from inventory
when you unload it from the instrument.
1. Go to the Reagent Inventory screen. To get to this screen from any screen, select
the Substrate, RVs, or RV Waste Bag button to display the Supplies screen, then
select Reagent Inventory F7.
(Optional) To easily locate the pack you want to delete, apply a filter to reduce
the number of packs displayed. For help on how to do this, see the Applying a
Filter to the Reagent Inventory Screen procedure.
3. Check to see if the reagent pack you selected is off board by verifying that the slot
and instrument fields are blank for this reagent pack.
(Optional) If the reagent pack is onboard an instrument, find and unload the
reagent pack. For help on how to do this, see the Unloading a Reagent Pack
procedure in Section 2.7: Reagent Packs.
Printing the Use this procedure to print the Reagent Inventory Report, containing all selected
Reagent packs or all packs in the current filter.
Inventory 1. Go to the Reagent Inventory screen. To get to this screen from any screen, select
Report the Substrate, RVs, or RV Waste Bag button to display the Supplies screen, then
select Reagent Inventory F7.
(Optional) To print the Reagent Inventory Report for one or more selected packs,
select the packs you want to print. If you do not select any packs, the system
prints the report for all packs displayed on the Reagent Inventory screen.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Reagent Inventory Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith
Test Name Lot No. Serial No. Tests Days Pack Calib. Slot Instrument
Left Open Expiration Expiration
PSA-Hyb 066851 3461 50 0 06/30/06 04/08/06 4 500135
PSA-Hyb 006851 3454 8 20 04/12/06 04/08/06 1 500135
PSA-Hyb 006851 2298 2 35 03/28/06 Unloaded
PSA-Hyb 006851 3010 7 38 03/25/06 Unloaded
MYO 093738 14283 47 7 04/25/06 04/05/06 8 501240
FOL2 085673 232 5 12 04/06/06 3 501240
FOL2 04/20/06
RBC2 None
Ferritin 105011 1259 17 5 04/27/06 04/20/06 6 501240
Ferritin 125002 3374 27 4 04/28/06 Unloaded
Ferritin 125002 1121 38 3 04/29/06 Unloaded
CK-MB 013055 956 50 0 01/31/07 None 15 501240
CK-MB 013055 842 50 0 01/31/07 None 14 501240
CK-MB 013040 1010 10 12 04/20/06 04/05/06 9 501240
aTnI 623123 11863 50 0 01/31/07 04/05/06 7 501240
aTnI 623123 8715 47 7 04/25/06 04/05/06 2 501240
aTnI 623123 4168 0 12 04/20/06 04/05/06 10 501240
aTnI 623123 1122 0 18 04/14/06 04/05/06 17 501240
Page 1 of 1
Technologist______________________________ Printed 04/04/06 02:43 PM
0746C.bmp
Figure 2-27 Reagent Inventory Report
3 Sample Management
3.1 Sample Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Adding Test Requests to Onboard Samples Using the Pause Button . . . . . . 3-55
Deleting Test Requests from Onboard Samples Using the Pause Button . . . 3-58
A test request includes a unique sample ID, information about the sample such as
patient ID and priority, and the tests you want to run on that sample.
You load samples onto the instrument in racks. Each rack is identified by a unique
bar-coded rack ID. When you load a rack onto the instrument, the system uses the
rack ID to identify the type of sample containers. In addition, the system displays
real-time summary information for each defined rack including:
• Location of the rack (onboard the instrument or not)
• Estimated time until the instrument completes aspirating all samples in the
rack
• Estimated time until the instrument completes processing all samples in the
rack
• Sample container positions in the rack
• Any sample management errors, such as an illegible bar code or no test
requests for a sample onboard the instrument
You can set up patient samples with or without a Laboratory Information System
(LIS). If you are using an LIS, the system downloads test request information
automatically after you load the rack. You cannot use an LIS to set up calibration,
quality control, or maintenance samples.
For information about how to process samples, see Chapter 4: Sample Processing.
Place samples
on racks
Main Menu
Sample Manager
F1
Sample Manager
Are
sample IDs
read by internal Test Request
No Enter a rack ID
F3
bar code
reader?
Test Requests
Yes
Test Request
Using LIS? No F3
All racks
No loaded? All racks
loaded?
No
Yes
Yes
Run
Run
0619D.wmf
Figure 3-1 Sample Management Flowchart
You access the Sample Manager screen from the Main Menu.
0586C.bmp
Figure 3-2 Sample Manager Screen
On Board (List) Displays a rack button for each rack that is onboard the instrument. You can
load up to six racks. Displays the most recently loaded rack button at the top. When
you unload the rack, the system moves the rack button to the Off Board list.
Off Board (List) Displays a rack button for each rack that is defined for the instrument, but is
currently not onboard. Displays the most recently unloaded rack button at the top.
When you load the rack, the system moves the rack button to the On Board list.
Rack ID (Indicator) Displays the rack ID of the selected rack.
NOTES:
• Rack IDs are shared across the Access 2 system. Each rack ID must be unique
across all instruments in a workgroup.
• To define a maintenance rack, you must enter the rack ID. If you load the rack and
wait for the internal bar code reader to scan the rack ID, the rack is designated for
sample processing and cannot be used for maintenance.
Rack Button (Button) Displays information for each rack. Each of the rack buttons contains the
following data:
• Rack ID (Indicator) Displays the rack ID associated with the information on the
Rack button.
• Rack status (Indicator) Displays the status of the rack when the status is
No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, and *Done*.
• The rack status is determined by the status of the least progressed, individual
samples. Asp. (Field) Displays the rack aspiration status.
• Comp. (Field) Displays the rack completion time.
• Rack Icon (Indicator) Displays the position of each sample container in the rack
and displays a red sample container in the corresponding position of the rack icon
to indicate any sample errors.
Load a Rack F1 (Button) Select to load a rack onto the instrument.
When the instrument presents an empty rack position on the sample carousel, you can
load the rack.
Work Pending F2 (Button) Select to display the Work Pending screen. You use this screen to view:
• Reflex tests for samples not onboard any instrument in a workgroup
• LIS test requests for samples not onboard any instrument in a workgroup
• Re-ordered tests from Test Results (Rerun test)
For more information about this screen, see Chapter 4: Sample Processing.
Test Request F3 (Button) Select to display the Test Requests screen. You use this screen to:
• Enter test requests for patient samples if you are not using an LIS
• Enter test requests for calibration and quality control samples
• Edit or delete test requests
• Monitor processing of specific samples
Maintenance (Button) Select to display the Request Maintenance window. You use this window to
Request F4 request one or a combination of the following maintenance routines:
• Daily Clean System
• Special Clean
• System Check
For more information about maintenance requests, see Chapter 8: Routine
Maintenance in the Operator's Guide.
Get Selected (Button) After you select a rack from the On Board list, select to get the rack from the
Rack F6 instrument. The system displays the Get Selected Rack window and presents the
selected rack. You can then add, remove, or rearrange samples or unload the rack
from the instrument.
NOTE: This button is only displayed when you select a rack from the On Board list.
Clear Selected (Button) After you select a rack from the Off Board list, select to delete all
Rack F7 information for the rack from the system. Clearing a rack removes the rack button
from the Sample Manager screen and any associated sample information from all
other screens, but does not delete the sample information from the database.
• You must clear a rack before you can reuse it.
• You cannot clear a rack from the On Board list.
The system prompts you to clear the rack when you unload a rack with a status of
Done or *Done*.
The system automatically clears racks with no test requests when you unload them.
NOTE: This button is only displayed when you select a rack from the Off Board list.
Change Rack (Button) After you select a rack from the Off Board list, select Change Rack ID F8 to
ID F8 edit the rack ID.
NOTE: This button is only displayed when you select a rack from the Off Board list.
Placing Sam- Place all samples to be tested on the Access 2 system in racks before loading the
ple Contain- samples onto the instrument. The rack ID on each rack identifies what type of sample
ers in Racks containers you may use in that rack. Each rack holds up to ten sample containers.
Place all sample containers except insert cups directly in the rack. Place insert cups
into another sample container appropriate for the rack you are using.
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Air bubbles in samples can affect level sensing by the Access 2 system and
compromise the integrity of test results. Avoid creating bubbles when
transferring samples to a secondary container. Always inspect samples
before loading on the instrument, and remove or break any bubbles.
• To minimize sample evaporation, be sure the sample is pipetted into the RVs
within one hour of loading it onto the instrument. Be sure sample from 3 mL
sample containers is pipetted into the RVs within two hours of loading.
• Use only recommended sample containers and place them in a rack with a
rack ID defined for that type of sample container. Using containers other
than those specified for use with a particular rack ID may damage the
system and compromise the integrity of test results.
• Remove caps from all sample containers before loading on the
Access 2 system.
For more information about appropriate sample containers, corresponding rack IDs,
calculating sufficient sample volumes, and using insert cups, see Appendix A: Racks
and Sample Containers.
For information about supported bar code symbologies, see Chapter 2: System
Specifications in the Reference Manual. For information about enabling, disabling,
and configuring the internal bar code reader, see Chapter 4: System Configuration in
the Reference Manual.
NOTES
• Be sure the rack ID bar code label is in good condition and is properly affixed
to the rack. For more information about properly applying rack ID bar code
labels, see Section A.1: Racks.
• You cannot load two racks with the same rack ID bar code label onto an
instrument.
• Within a workgroup, each instrument must use racks with unique ID bar code
labels. The same rack ID cannot be used on more than one instrument in the
workgroup.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
3. Open the sample carousel door, then pick up the rack by the handle and lower it
onto the sample carousel (see Figure 3-4).
Be sure the rack is within the guides of the carousel, and allow the lip of the rack to
guide it into position. The peg below the rack handle (under the lip) should rest in the
notch on the sample carousel.
0011D.eps
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
4. Open the sample carousel door, then unload the rack by holding onto the rack
handle and lifting upward.
NOTE
You can view the maintenance sample progress from the Maintenance Requests
screen. For more information about maintenance samples, see
Section 8.1: Routine Maintenance.
Resolving If a sample error occurs after you load a rack, the system turns the affected sample
Sample Errors container red in the rack icon on the Sample Manager and Test Requests screens, and
displays a specific error message or indicator in the corresponding Status field on the
Test Requests screen.
Use this procedure to resolve any sample management errors that occur after you load
a rack.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the On Board list, locate the red sample containers (sample errors) in the rack
icon
5. Look for error messages in the Status field of the sample that has the error.
6. Take the necessary action to resolve the sample error. For more information, see
Appendix A: Troubleshooting in the Reference Manual.
Changing Use this procedure to change the rack ID of a rack that is not onboard the instrument.
Rack IDs
NOTES
• You cannot change the rack ID of an onboard rack. If you need to change the
rack ID of an onboard rack, you must first unload the rack.
• You cannot change to a rack ID that is already assigned to another rack in the
On Board or Off Board lists.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the Off Board list, select the rack that you want to change.
NOTE
A rack ID that was entered manually will override an ID that was scanned. As
you type rack IDs, be sure the numbers you enter into the appropriate field are
correct.
5. Select OK F1.
The system displays a confirmation window.
6. Select OK F1 .
The system changes the rack ID on the rack button.
Clearing Use this procedure to clear a rack button from the Off Board list on the Sample
Racks Manager screen.
When you clear (delete) a rack button from the Off Board list on the Sample Manager
screen, all the sample information associated with the rack is cleared from the Test
Requests or Maintenance Requests screen.
NOTES
• You must clear a rack before you can reuse it.
• You cannot clear an onboard rack.
• The system prompts you to clear the rack when you unload a rack that is
Done or *Done*.
• The system automatically clears racks with no test requests when you unload
them.
• Clearing a rack does not delete sample information, test results, or the rack
ID associated with the test results from the database.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the Off Board list, select the rack you want to clear.
Entering Sam- Use this procedure to enter, edit, or delete comments for patient or quality control
ple Com- samples on the Test Requests screen.
ments 1. Select the Pen or Notepad button to display the Sample Comment window.
2. In the Comment field, enter or edit comments. Or, to delete an existing comment,
select it and press [Backspace].
Changing the You can only change or set a reagent lot number when the reagent lot is in inventory
Reagent Lot and the sample status is Requested. To add a lot to the reagent pack inventory, load
for Running the reagent pack.
Calibrations For more information about loading reagent packs, see Section 2.7: Reagent Packs.
or Controls
Changing Reagent Lots for Calibration Requests
When you enter a calibration request, the system assigns a reagent lot number from a
previously calibrated lot. Change the reagent lot number whenever you calibrate a lot
for the first time.
For more information about entering calibration requests, see Section 3.3: Calibration
Test Requests.
Use this procedure to change a reagent lot number for a calibration test request from
the Test Requests screen.
On the Test Request screen for a calibration request, the calibrator set is selected by
default.
1. Confirm that the Test menu is displayed.
If the Test menu is not displayed, select Show Test Menu F3 from the Test Request
screen.
The system displays the Test menu.
3. Select the new lot number from the Reagent Lot list and select OK F1.
The system changes the reagent lot number and displays the Test Requests screen.
Use this procedure to set a specific reagent lot number for a quality control test
request from the Test Requests screen.
1. From the Test Requests screen, select the quality control for which you want to
set a reagent lot.
3. Select the test from the Tests Requested for Sample X list.
5. Select the new lot number from the Reagent Lot list and select OK F1.
The system changes the reagent lot number and displays the Test Requests screen.
NOTE
If a reagent lot is set and you want to let the system set the lot, select Any.
6. To set the lot for another test or quality control, repeat this procedure.
Requesting Technical Support representatives use service assays for instrument diagnostics.
Service
NOTE
Assays
Use this window only as directed by your technical support representative.
Before you can request a test for any sample, you must configure the test in the
system. When configuring tests, you can modify system default values, such as the
test ID, sample type, and reflex test conditions. For each patient test request, you must
enter a unique sample ID per instrument and a list of tests to run. For all tests, the
system supplies default values, including priority (routine) and dilution factor (1).
You can edit any of these fields and also enter sample comments.
If you use an LIS to download patient test and sample information, you load the rack
to begin test requests. The system automatically scans the rack ID and sample IDs,
and downloads test request information. You can verify or modify the information,
and then start processing. If you are using a bar-coded sample container, the system
scans the sample ID and any other bar-coded information and enters the information
in the appropriate fields and positions.
If you do not use an LIS or bar-coded sample containers, you select or enter test
request information manually before processing.
To simplify entering test requests manually, you can use the Auto Sample ID option
to automatically assign sequential sample IDs and use the Batch Request option to
automatically request the same tests for each sample.
For information about how to configure tests, see Chapter 4: Sample Processing in the
Reference Manual.
For more information about how to edit or delete patient test requests, see
Section 3.5: Working with Onboard Samples.
For information about how to review patient test results, see Chapter 5: Test Results.
You access the Test Requests screen from the Main Menu.
Position
Selected
Sample
Selected
Tests
0583D.bmp
Figure 3-6 Test Requests Screen
Rack Icon (Indicator - Rack Icon) Displays the rack ID and position of each sample container in
the rack.
If any of the following sample management errors occur after loading, the system
turns the affected sample container red:
• The internal bar code scanner could not read the bar code on the sample container
• A sample container is missing or is not in the correct position (for manual requests
only)
• There is not enough sample to complete one or more tests
For more information about resolving sample management errors, see Section A.4:
Assay Troubleshooting in the Reference Manual.
Rack Status (Field) Displays the sample processing status for the rack as determined by the least
processed sample in the rack.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, or
*Done*.
For more information about rack statuses, see Section 4.4: Monitoring Sample
Progress.
Batch Request (Indicator) Displays the text "Batch Request" to the left of the rack location when you
turn Batch Request on. When turned off, this indicator is not shown.
For more information about Batch Request, see the Using Batch Request procedure.
Auto Sample ID (Indicator) Displays the text "Auto Sample ID" to the right of the rack status when
you turn Auto Sample ID on. When turned off, this indicator is not shown.
For more information about Auto Sample ID, see the Using Auto Sample ID
procedure.
Position (Button) Select to enter information about the sample in rows numbered 1-10. The
rows correspond to the ten positions in the selected rack, from left to right with the
convex side of the rack facing you.
The fields in each sample position row pertain to the sample in that position on the
rack.
Sample ID (Field) For patient samples, enter a unique sample ID. Sample IDs are unique for
loaded samples on the same instrument.
NOTES
• You can use a maximum of 15 characters, numbers 0 through 9, uppercase
and lowercase letters A through Z, asterisk (*), slash (/), plus (+), and minus
(-).
• Spaces, punctuation marks, and special characters are not accepted.
For quality control samples, select Request QC F5 to select the quality control name.
For calibration samples, select Request Calibration F6 to select the calibrator set
name.
If you are using bar-coded sample containers, the system scans the sample ID and any
other bar-coded information and enters the information in the appropriate fields and
positions after you load the rack.
Patient ID/Lot (Field) For patient samples, enter an optional patient ID (1-15 alphanumeric
Number characters). If you enter a quotation mark ("), characters to the right of the quotation
mark may not print on reports.
NOTES
• A patient ID is required for LIS test requests.
• For the Simplified Chinese language, the 15 character limit is determined by
the combined length of the Simplified Chinese and alphanumeric characters
you enter in this field. The system counts a Simplified Chinese character as
two characters, and an alphanumeric character as one character.
For quality control or calibration samples, you can select one of the available lots
from the list.
For more information about QC setup, see Chapter 7: Quality Controls.
For more information about calibration setup, see Chapter 6: Assay Calibrations.
Dilution (Field) For patient samples, enter the dilution factor for any sample you dilute prior to
loading onto the system. The default value is 1 (no dilution 1/1). You can change the
default to a new value from 1-999. The system multiplies the test result by the number
you enter.
For quality control and calibration samples, this field is unavailable.
Sample Type (Field) For patient samples, select the type of fluid in the sample container.
Before you enter or download test requests for a sample, the default is Serum. After
you enter or download test requests, the default changes to the sample type
configured for the first selected test. To change it, select another sample type.
Values are: Serum, Urine, CSF, W. Blood, Plasma, Other, Amniotic, Urethral,
Cervical, or Synovial.
If you want to process more than one sample type for the same patient, you must enter
separate test requests using a unique sample ID for each sample type.
For quality control and calibration samples, the system supplies the sample type
configured for the quality control or calibrator.
STAT (Box) For patient samples, select to process the sample with STAT priority (before all
other samples). Clear to process the sample with routine priority.
Because STAT samples are processed before calibrations, verify that all tests
requested for a STAT sample have an active assay calibration (see Chapter 6: Assay
Calibrations).
Comment (Pen or Notepad Button) For patient and quality control samples, select to display
the Sample Comment window and add, edit, or delete sample comments.
If there are no comments associated with the sample, the system displays
the Pen button.
If a comment has been entered for a sample, the system displays the
Notepad button.
The system displays sample comments on test result reports and on the Quality
Control screen and reports.
Completion (Field) Displays the estimated time the system will finish processing all tests
requested for the sample. The format of this field is defined when you configure the
system.
If the system has not started processing any of the tests, this field is blank. If the
system schedules a reflex test for the sample, the system recalculates the completion
time.
Status (Field) Displays the sample status, as determined by the least processed test requested
for the sample. For more information, see the Sample Status topic in
Section 4.4: Monitoring Sample Progress.
If the system cancels a test, it records the test name and sample ID on the Event Log
screen and the Event Log button turns red.
Selected Tests (Field) Displays a list of all tests requested for the sample. The tests requested for the
sample are also called the test list.
For patient, quality control, and calibration samples, the system indicates replicates
by a number in parentheses after the test name. For calibration and quality control
samples, the system displays the reagent lot number in parentheses after the test
name.
To add, delete, or edit tests from the selected tests list, use the Test menu.
For more information about using the Test menu, see the Entering Patient Test
Requests Manually procedure.
Load Rack X F1 (Button) X is the rack ID of the rack selected on the Sample Manager screen. If the
or selected rack is not onboard, select Load Rack X F1 to load it. If the selected rack is
onboard, select Get/Edit Rack X F1 to present the rack at the sample carousel door,
Get/Edit Rack where you can unload the rack, add, remove, or rearrange samples.
X F1
Delete Sample F2 (Button) Select to delete all selected sample information from the Test Requests
screen.
You can only delete a sample when the rack is not onboard, the sample status is
Requested or Supply Wait, or when all of the test statuses are Requested or Supply
Wait.
Show / Hide Test (Button) Select Show Test Menu F3 to display the Test menu. Select Hide Test
Menu F3 Menu F3 to hide the Test menu.
You use the Test menu to request tests to run on the selected sample. The menu
moves up and down as you select a different sample position so it does not overlap
the position you are entering information for. You do not have to hide the Test menu.
Test Results F4 (Button) Select to display the Test Results screen, filtered to display results for all
samples on the selected rack. The sample selected on the Test Requests screen is also
selected on the Test Results screen.
NOTE: When you select Test Results F4, the On-Board Patient Sample filter is
automatically applied to the Test Results screen. Therefore, if you select an
offboard rack on the Test Requests screen, the results for that rack are not
displayed.
Request QC F5 (Button) For quality control samples, select to display the Request QC window. You
use the Request QC window to select the name of the quality control you want to run
from a list of quality controls defined across all systems in a workgroup.
When the selected sample position contains a patient sample or calibration request,
the system displays an error message.
Request (Button) For calibration samples, select to display the Request Calibration window.
Calibration F6 You use the Request Calibration window to select the calibrator you want to run from
a list of calibrators defined across all systems in a workgroup.
When the selected sample position contains a patient sample or quality control
request, the system displays an error message.
Clear All (Button) Select to clear all sample fields for the current rack.
Samples F7
More Options F8 (Button) Select to display a menu of the following options:
• Turn Batch Request On/Off F1
If you are not using an LIS, after you enter the sample IDs and select tests for the
first sample, select to request the same tests for subsequent samples. When you
turn Batch Request on, the system displays Batch Request on the top right side of
the screen.
• Turn Auto Sample ID On/Off F2
If you are not using bar-coded sample IDs, after you enter the first sample ID,
select to enter sample IDs automatically for subsequent samples. Each ID will be
numerically increased by 1. When you turn Auto Sample ID on, the system
displays Auto Sample ID on the top right side of the screen.
• Request Service Assay F3
Displays the Request Service Assay window. Use this window only as directed by
your technical support representative.
Navigating If you are using the keyboard to navigate the Test Requests screen, the cursor
the Test movement on this screen is different from other screens.
Requests When you go to the Test Requests screen, the cursor will be in the Sample ID field for
Screen the first position on the rack. You can press [Tab] to move the cursor through the
subsequent fields. Pressing [Tab] moves the cursor through the fields in this order:
• Patient ID/Lot Number
• Test Menu
• Dilution
• Sample Type
• STAT
You can press [Enter] to validate information you enter into a field, and to move the
cursor through a limited number of fields. From the Sample ID field, pressing [Enter]
moves the cursor through the fields in this order:
• Patient ID/Lot Number
• Test Menu
NOTE
To access the Comment window you must select the Pen or Notepad button. You
cannot navigate to this window using the [Tab] or [Enter] keys.
You can use the up and down arrow keys to move the cursor vertically through the
sample positions.
You can use the left and right arrow keys to move the cursor through the fields in the
same order as the [Tab] key. However, once you enter information into an editable
field, these arrow keys move the cursor through the field by individual characters until
you reach the end of the field.
Processing
LIS Patient Main Menu
Test Requests
Sample Manager
F1
Sample Manager
Load a Rack
F1
All racks
No
loaded?
Yes
System downloads
test requests from LIS
Verify downloaded
sample and test
information and make
any necessary changes
Run
0621C.wmf
Figure 3-8 Processing LIS Test Requests
If you are using bar-coded sample containers and are downloading test requests from
an LIS, use this procedure to load racks and run the tests for LIS patient test requests.
You can load up to six racks at one time.
NOTES
• If you want to load another rack after you select Run (the last step of the
procedure), you must wait for the system to update all of the tests before you
continue. You can avoid waiting if you load all the racks at the same time.
• Be sure that the rack and sample ID bar code label is in good condition and is
properly affixed to the rack. For more information about properly applying
rack ID bar code labels, see Section A.1: Racks.
• Be sure the appropriate tests are enabled before entering test requests. The
system will reject an LIS test request if the associated test has not been
enabled. For more information about enabling tests, see Section 4.4: Test
Setup in the Reference Manual.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Place the samples in the rack(s). For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks and
Sample Containers in this manual. For assay-specific sample volume information, see
the reagent instructions for use.
3. Load a rack.
a. Select Load a Rack F1.
If the system is processing samples, it enters the Paused mode. The
instrument presents a rack position in the sample carousel.
b. Pick up the rack by the handle and lower the rack onto the sample carousel
(see Figure 3-4).
Be sure the rack is within the guides of the carousel, and allow the lip of the
rack to guide it into position. The peg below the rack handle (under the lip)
should rest in the notch on the sample carousel.
c. Select Done F1.
The instrument scans the rack and samples and downloads test requests from
the LIS.
NOTE
After the system starts scanning, you can interrupt the scan to load another rack.
The system cancels the scan as soon as you select Load a Rack F1. However,
there is a slight delay before it presents the rack position.
NOTE
If you already entered sample IDs on the Test Requests screen, and the sample
IDs scanned do not match the IDs you entered, the system uses the sample IDs
you entered.
Entering
Patient Test Main Menu
Requests
Manually
Sample Manager
F1
Sample Manager
Enter rack ID
or select rack button
from Off Board list
Test Request
F3
Test Requests
Place samples
in racks
Load Rack X
F1
All racks
loaded? No Back
Yes
Run
0618D.wmf
Figure 3-9 Entering Patient Test Requests Manually
If you have disabled sample bar code scanning, or need to enter test requests and
sample information manually, use this procedure to manually enter test requests.
NOTES
• Do not enter a quotation mark (") in an available field. If you do, characters
to the right of the quotation mark may not print on reports.
• If you want to load another rack after you select Run (the last step of the
procedure), you must wait for the system to update all of the tests before you
continue. You can avoid waiting, if you load all the racks at the same time.
• You can use other procedures in this chapter to enter test requests for
calibration or quality control samples. These samples can be placed in the
same rack with patient samples.
• Be sure that the rack ID bar code label is in good condition and is properly
affixed to the rack.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Select the rack button from the Off Board list, or enter the rack ID in the Rack ID
field and press [Enter].
NOTE
If you will be entering additional samples, you can use the Auto Sample ID
option to simplify entering this information. For more information, see the Using
Auto Sample ID procedure in this chapter.
5. Using the Test menu, select the tests you want to run on the sample.
If the Test menu is not shown, select Show Test Menu F3 to display the menu.
NOTE
If you will be entering additional samples, you can use the Batch Request option
to simplify entering this information. For more information, see the Using Batch
Request procedure in this chapter.
0697B.bmp
Figure 3-10 Test Menu (Patient Samples)
Tests Requested (List) Displays test names selected to run on the sample (X
for Sample X is the selected sample position). Displays the number of
selected replicates in parentheses after the test name.
Test (Field) Displays the test ID or test name for the selected
test. You can type a test ID or test name in this field to
request the test instead of using the test buttons. You can
add a test replicate with the [+] key, or subtract a test
replicate with the [-] key.
Remove (Button) Select this button to remove one replicate of the
test selected in the Tests Requested for Sample X list.
Test Buttons (Buttons) Each button displays the test name and test ID for
an available test or test panel. Select to add one replicate of
the test. If you select a button for a test panel, one replicate
of each individual test associated with that panel is added
to the Tests Requested list.
6. Review the values for the Dilution, Sample Type, STAT, and Comment fields
and edit them if necessary.
(Optional) To enter additional samples, repeat step 4 through step 6 for each
additional sample.
NOTE
If you are entering a STAT sample, verify that the tests requested have active
calibrations.
(Optional) To delete a test for a sample, select the test in the menu list and select
Remove.
7. Place the samples in the rack. For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks and
Sample Containers in this manual. For assay-specific sample volume information, see
the reagent instructions for use.
NOTES
• When configuring the system, you can disable sample ID bar code scanning,
but tube detection and rack ID scanning are always enabled. If the internal
bar code reader cannot read a rack ID, you must relabel the rack with a
readable label or use a different rack.
• If the rack ID you entered does not match the rack ID scanned, the system
displays an error message. You must return to the Sample Manager screen,
unload the rack, and either load the right one or change the rack ID.
• If the tube detector does not detect a sample container in a position that has
requested tests, the system deletes the sample from the Test Requests screen.
For more information about sample processing, see Section 4.1: Sample Processing.
Using Auto
Sample ID
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Enter sample ID
for first sample
More Options
F8
Turn Auto Sample ID On
F2
Yes Run
The system
automatically enters
the sample ID
0512C.wmf
Figure 3-12 Using Auto Sample ID
The Auto Sample ID option simplifies test request entry when you are not using
bar-coded sample IDs, and your sample IDs are consecutive. After you enter the first
sample ID, the system enters sample IDs automatically for subsequent samples. Each
ID will be numerically increased by 1.
For example, if the first sample ID is PAT11, the next sample ID will be PAT12, and
so on. If the first sample ID ends with a non-numeric character, the system adds a 1 to
the next sample ID and then increments subsequent sample IDs. For example, if the
initial sample is SampleA, the next sample ID will be SampleA1, the next will be
SampleA2 and so on.
Use this procedure to turn the Auto Sample ID option on or off during the Entering
Patient Test Requests Manually procedure.
1. Go to the Test Requests screen. To get to this screen from the Main Menu, select
Sample Manager F1.
3. Select Test Request F3. Type the sample ID for the first sample and press
[Enter].
4. Select More Options F8, then select Turn Auto Sample ID On F2.
5. Enter the rest of the test request information for the sample.
(Optional) To alter the sample ID sequence, select the Sample ID field and enter a
new ID.
(Optional) To turn off Auto Sample ID, select More Options F8, then select Turn
Auto Sample ID Off F2.
Using Batch
Request Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Type sample ID for the first
sample and select tests to
run
More Options
F8
Turn Batch Request On
F1
Test Requests
The system
automatically selects
same tests for
next sample
Done entering
No
samples?
Yes
Run
0513C.wmf
Figure 3-13 Using Batch Request
The Batch Request option simplifies test request entry when you are not using an LIS
to download test requests. You can use this option if you are manually entering
sample IDs, but it is most effective if you use it along with bar-coded sample IDs.
After you request tests for the initial sample, the system assigns the same tests to
subsequent samples.
Use this procedure to turn the Batch Request option on or off.
1. Go to the Test Requests screen. To get to this screen from the Main Menu, select
Sample Manager F1.
3. Select Test Request F3. Type the sample ID and enter the tests you want to run,
then press [Enter].
5. Enter the rest of the test request information for the sample.
6. Select the next sample position, enter the sample ID, and press [Enter].
The system automatically selects the same tests for the sample in the position you
selected.
(Optional) To turn off Batch Request, select More Options F8, then Turn Batch
Request Off F1.
Reusing Sam- You must delete a sample ID from the system before it can be reused.
ple IDs In order to reuse a sample ID, you must first complete the following steps.
1. On each instrument in the workgroup, unload and clear all racks that contain the
sample ID. For more information, see Section 3.1: Sample Management.
2. Delete all test results associated with the sample ID. For more information, see
Section 5.3: Managing Test Results. To configure the system to automatically
delete test results, see Section 4.10: PC Administration Setup in the Reference
Manual.
3. Be sure each test you will request for the reused sample ID is enabled. For more
information, see Section 4.4: Test Setup in the Reference Manual.
4. Delete all work pending tests associated with the sample ID. For more
information, see Section 4.3: Work Pending.
Calibrators are samples of known reactivity specific for calibrating an assay on the
Access 2 system. You run calibration samples on the Access 2 system to establish
values the system uses to assess test results for patient and quality control samples.
The system requires an active (accepted, not expired) assay calibration for each
requested test.
You run a calibration by setting up a set of calibrators specific for an assay or group of
assays. Each calibration is associated with a specific reagent pack lot number.
You can run a calibration at any time, or when the system prompts you. Beckman
Coulter recommends that you perform assay calibration under the following
circumstances:
• When you switch to a new reagent lot, or to a new reagent shipment within
the same lot
• When the active calibration has expired
• When quality control data indicates calibration is necessary
• When a major system component has been repaired or replaced
NOTES
• You must configure each new lot of calibrators before you can use them for a
calibration.
• Some assays require temperature restrictions. See Appendix A of the
Access 2 Instructions for Use manual for information on these restrictions.
For information about how to edit or delete calibration test requests, see
Section 3.5: Working with Onboard Samples.
For information about how to load a new reagent pack, see Chapter 2: Supplies.
For information about how to review calibration data and determine if a test has an
active assay calibration, see Chapter 6: Assay Calibrations.
Entering Cali-
bration Test Main Menu
Requests
Sample Manager
F1
Sample Manager
Test Requests
Request Calibration
F6
Request Calibration
OK
F1
Test Requests
Run
0510C.wmf
Figure 3-14 Entering Calibration Test Requests
Use this procedure to enter test requests for a set of calibration samples.
NOTES
• The system processes calibration samples before quality controls and routine
patient samples.
• You must set up each new calibrator before you can perform a calibration
using that lot.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Select the rack button from the Off Board list, or enter the rack ID in the Rack ID
field and press [Enter].
2164B.bmp
Figure 3-15 Request Calibration Window
0698B.bmp
Figure 3-16 Test Menu (Calibration)
Reagent (List) Displays the test name associated with the selected
calibrator.
Reagent Lot (List) Displays the selected reagent lot number associated
with each selected test.
Test (Field) Displays the test ID or test name for the selected
test.
Change Reag. (Button) Select to display the Change Lot Number window
Lot and choose a different reagent lot.
NOTE: You can only change the reagent lot if the sample
status is Requested.
(Optional) To change the reagent lot for a calibrator, select the calibrator set, then
select Change Reag. Lot. For more information about changing the reagent lot,
see the Changing the Reagent Lot for Running Calibrations or Controls procedure
in this chapter.
(Optional) To change the calibration test, select Delete Sample F2, then return to
step 4.
(Optional) To hide the Test menu, select Hide Test Menu F3.
6. Place the samples in the rack(s). For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
NOTE
Be sure that each calibrator in the set is in the same type of sample container, then
place the calibration samples for the entire calibration set in the same rack.
For information about sample containers and volumes, see Appendix A: Racks and
Sample Containers in this manual. For assay-specific sample volume information, see
the reagent instructions for use.
7. Load the rack (see the Loading Racks procedure in this chapter).
(Optional) To request additional calibration sets, repeat step 2 through step 6. Or,
use other procedures in this chapter to request patient or quality control samples.
Quality control samples are commercially available samples of known reactivity. You
run quality control samples along with patient samples to monitor analytical variation
on your Access 2 instrument and to ensure the validity of patient sample results.
You run quality controls by entering a quality control test request for a quality control
sample or set of samples. When you enter a quality control test request, you select a
specific quality control lot number from the Request QC window.
You should run quality control samples as recommended in the QC instructions for
use and after any scheduled or unscheduled maintenance to verify assay calibration.
Also, after successfully installing new software, Beckman Coulter recommends
running quality controls for all assays you use to report patient results, then
recalibrating any assays with out of range QC results.
To best simulate the characteristics of patient samples, use quality control samples
prepared from material similar to the patient samples you are testing. For example, if
testing serum, use serum-based quality control samples.
NOTE
You must set up each new quality control lot in the Access 2 system before you
can select it during test request entry.
For information about how to edit or delete quality control test requests, see
Section 3.5: Working with Onboard Samples.
For information about how to review quality control data, see Section 7.2: Reviewing
Quality Control Charts and Data.
Entering
Quality Con-
trol Test Main Menu
Requests
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Request QC
F5
Request QC
Test Requests
Load Rack X
F1
Run
0511C.wmf
Figure 3-18 Entering Quality Control Test Requests
Use this procedure to enter a test request for a quality control sample or set of
samples.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Select the rack button from the Off Board list, or enter the rack ID in the Rack ID
field and press [Enter].
3. Select Test Request F3 to display the Test Requests screen, then select Request
QC F5.
2047C.bmp
Figure 3-19 Request QC Window
NOTE
The Request QC window displays the quality controls set up on all systems in a
workgroup.
0699B.bmp
Figure 3-20 Test Menu (QC)
NOTE
You can only change the reagent lot when the sample
status is Requested.
Remove (Button) Select a test from the Reagent list, then select this
button to remove one replicate.
Test Buttons (Buttons) Each button displays the test name and test ID for
an available test or test panel. Select to add one replicate of
the test. If you select a button for a test panel, one replicate
of each individual test associated with that panel is added
to the Reagent list.
5. Select the tests you want to run on the QC sample. The Reagent list in the Test
menu displays the selected tests.
(Optional) To set the reagent lot for a test, select the test, then select Change
Reag. Lot. For more information, see the Changing the Reagent Lot for Running
Calibrations or Controls procedure in this chapter.
(Optional) To hide the Test menu, select Hide Test Menu F3.
(Optional) To enter or edit comments, select the Pen or Notepad button. For
more information, see the Entering Sample Comments procedure in this chapter.
6. Place the QC samples in the rack(s). For more information, see the Placing
Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks and
Sample Containers in this manual. For assay-specific sample volume information, see
the reagent instructions for use.
7. Load the rack(s). For more information, see the Loading Racks procedure in this
chapter.
The Access 2 system allows continuous access to sample information. You can edit
active test request fields, select additional tests, cancel selected tests, delete tests, and
add, remove, or rearrange samples while the system continues processing.
If the sample rack containing the sample you want to work with is onboard, and the
system is in the Running mode, you must stop aspiration activity before working with
the onboard sample by pausing the instrument or getting the rack. Pausing the
instrument does not affect tests already in progress.
NOTE
In general, if you use an LIS to download test requests, you should use the LIS to
add, edit, or delete test requests. The LIS expects to receive results from the
Access 2 system for all tests downloaded for a sample. If you use the Test menu
to delete a downloaded test request, the Access 2 system does not inform the LIS
of the deletion, and the LIS continues to expect a result for the test. Likewise, if
you use the Test menu to add a test request, the LIS may not recognize uploaded
results for the added test. See your LIS documentation or contact your LIS vendor
for details.
For information about how to load, unload, and clear racks, and to change rack IDs,
see Section 3.1: Sample Management.
Adding,
Removing,
and Rearrang-
ing Onboard
Main Menu
Samples
Sample Manager
F1
Sample Manager
Done
F1
Run
0848B.wmf
Figure 3-22 Adding, Removing, and Rearranging Onboard Samples
Use this procedure to access an onboard rack so you can add, remove, or rearrange
samples.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• If you are using the internal bar code reader to scan sample IDs, you should
only work with onboard samples without unloading the rack.
• If sample ID scanning is disabled, you can unload the rack, add, remove, or
rearrange samples as you edit the necessary information on the Test Requests
screen, and then reload the rack.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Select the rack you want to work with from the On Board list.
CAUTION
If the rack status is Aspirated, the system displays a warning message that
reflex tests could be scheduled for samples on that rack. If you choose to
remove samples scheduled for reflex tests from the rack, the system will
display the scheduled reflex tests on the Work Pending screen. You will have
to reload the sample(s) to run the reflex tests.
4. Open the sample carousel door and add, remove, or rearrange samples. You do
not need to unload the rack.
Editing Test
Requests for Main Menu
Onboard
Samples
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Get/Edit Rack X F1
System
No processing
samples?
Yes
System enters
Paused mode
Test Requests
All samples
No edited?
Yes
Done
F1
Run
0514C.wmf
Figure 3-23 Editing Test Requests for Onboard Samples
Use this procedure to edit a test request for a sample that is in an onboard rack.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the On Board list, select the rack with the test request to be edited.
• Dilution
• Sample Type
• STAT
• Comment
NOTES
• If you edit the sample ID for a test request, all information associated with
that sample, including the tests you have requested, is removed from the test
request.
• For any instrument in a workgroup, the patient ID cannot be edited after a test
associated with the sample ID has been pipetted.
For more information about these fields, see the Test Requests screen descriptions
(see Table 3-7).
(Optional) To edit tests, select Show Test Menu F3. Select the test you want to
edit.
7. To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample Processing.
Deleting Test
Requests for
Main Menu
Onboard
Samples
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Get/Edit Rack X
F1
Remove
F2
Done
F1
Run
0517C.wmf
Figure 3-24 Deleting Test Requests for Onboard Samples
Use this procedure to delete a test request for a sample in an onboard rack.
NOTE
You can delete a test request only if the sample status is Requested, In
Progress, or Supply Wait.
1. Go to the Sample Manager screen.To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the On Board list, select the rack containing the sample with the test request to
be deleted.
6. In the Test menu, select the test to be deleted from the Tests Requested for
Sample X list.
8. To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample Processing.
Adding Test
Requests to
Main Menu
Onboard
Samples
Using the
Pause Button Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Get/Edit Rack X
F1
Remove
F2
Done
F1
Run
0934B.wmf
Figure 3-25 Adding Test Requests to Onboard Samples Using the Pause
Button
Use this procedure to add a test request for a sample in an onboard rack using the
Pause button.
NOTE
The instrument must be in the Running mode to use this procedure.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the On Board list, select the rack containing the sample that requires additional
test requests.
4. Select Pause.
The system enters the Paused mode, but does not present the selected rack.
Deleting Test
Requests
from Onboard Main Menu
Samples
Using the
Pause Button
Sample Manager
F1
Sample Manager
Test Request
F3
Test Requests
Pause
Select sample
containing the test
request to be deleted
Remove
F2
Run
0935B.wmf
Figure 3-26 Deleting Test Requests from Onboard Samples Using the
Pause Button
Use this procedure to delete a test request for a sample in an onboard rack using the
Pause button.
NOTE
The instrument must be in the Running mode to use this procedure.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. In the On Board list, select the rack containing the sample with the test requests
to be deleted.
NOTE
You cannot delete test requests if the rack status is In Progress, Aspirated,
*Done*, or Done.
4. Select Pause.
The system enters the Paused mode, but does not present the selected rack.
6. In the Test menu, select the test to delete from the sample.
NOTES
• You cannot delete test requests from samples that have any of the following
sample statuses: In Progress, Aspirated, or Done.
• If the sample has test requests that are Requested and In Progress, you can
delete any test requests with the Requested status. If you delete all
Requested test requests, the sample status changes to In Progress.
4 Sample Processing
4.1 Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Sample processing begins after you verify supplies, load samples, enter or verify test
request information, and select Run.
The Access 2 system is dynamic. When you select Run, the system automatically
determines the optimal sample processing order and immediately begins to process
the samples it can. The system alerts you if you need to replenish supplies, calibrate
any test, or respond to the system in any other way. For the most efficient throughput,
verify that the instrument has the supplies and valid calibrations needed to process all
samples before you select Run.
If you are using an LIS to enter patient test requests and the system is in the Running
mode, the system automatically downloads the requests as they are received.
• If the sample for downloaded test requests is onboard the system adds the
requests to the current run. If supplies and calibrations are sufficient, the
system automatically processes the downloaded tests. You do not need to
select Run again. If supplies or calibrations require attention, the system
assigns the Supply Wait status to the tests it cannot process, and the
Supplies Required button turns yellow. You must load supplies, change
waste containers, or recalibrate before the system can process the tests with
Supply Wait status.
• If the sample for downloaded test requests is not onboard, the system puts the
test requests in the work pending list, and the Work Pending button turns
yellow. You must load the sample before the system can process the
downloaded test requests.
While the system is processing tests, you can monitor the progress of each onboard
sample and requested test.
You can process multiple containers with the same sample ID on multiple
instruments. However, you cannot process multiple containers with the same sample
ID concurrently on the same instrument.
The Access 2 system allows continuous access, so you can add or remove most
supplies, add or remove samples or racks, or change waste containers during
processing. You can also pause processing to add or delete test requests.
NOTES
• You cannot change the substrate bottle while the system is in the Running
mode.
• You cannot load or unload racks or supplies or add or delete tests for onboard
racks while maintenance routines are in progress.
If you configured your system with reflex testing enabled, the system orders reflex
tests automatically when the defined conditions are met and the sample is onboard an
instrument in the workgroup.
To be sure the Access 2 system continues to run efficiently, you must perform routine
daily and weekly maintenance procedures.
For information about how to load samples and enter or verify test request
information, see Chapter 3: Sample Management.
For more information about reflex testing, see Chapter 4: System Configuration in the
Reference Manual.
(optional) (optional)
Monitor progress Supplies or
Samples Monitor progress
View results No calibration No
required? View results
Print results required?
Print results
Yes Yes
Override
F8
Yes
(optional)
Override Apply filter
Correct the Load samples
No expired supply/ No condition now?
calibration? Delete samples
Print report
Yes
Load supply,
change waste
container, or
request calibration
0518B.wmf
Figure 4-1 Processing Samples Flowchart
Starting Sam- Use this procedure to begin processing samples after you verify supplies, load
ple Process- samples, and enter or verify test request information.
ing 1. Select Run.
The Access 2 system determines the testing sequence and begins the tests it can
complete under current conditions.
NOTE
You cannot select Run from a limited number of screens, such as Diagnostics
screens.
2. Review the system status buttons for items that require attention. Select the
button to display the corresponding screen, and take appropriate action.
• If a test requires calibration or the system needs any supplies, the Supplies
Required button turns yellow. For information about Supplies Required, see
Section 4.2: Supply and Calibration Conditions.
• If the system requires samples, the Work Pending button turns yellow. For
information about Work Pending, see Section 4.3: Work Pending.
• If the system detects an operational error, the Event Log button turns yellow or
red. Select the button to display the corresponding screen. For information about
the Event Log, see Chapter 6: Event Log in the Reference Manual.
NOTES
• When the system has completed or canceled the last test on the last onboard
rack, it automatically rinses the aspirate probes by running the Utility Assay.
• Unless there is an emergency, let the Utility Assay run to completion.
Pausing Sam- Use this procedure to temporarily pause the instrument when it is in the Running
ple Process- mode.
ing NOTES
• You cannot pause the instrument during a maintenance routine.
• You can make changes to onboard samples and test requests while the system
is in the Paused mode. For more information, see Section 3.5: Working with
Onboard Samples.
CAUTION
Stopping processing cancels any tests in progress and may leave devices
away from their home positions. After you stop processing, you must
initialize the system and run the Utility Assay before you can start
processing again.
For detailed information about the Utility Assay, see Chapter 8: Routine
Maintenance.
Sample Pro- When you start sample processing, the system determines the optimal processing
cessing Order order using the following criteria, and begins processing the samples with the highest
priority first.
Priority Criteria
1 Type:
1st—STAT patient samples
2nd—Calibration samples
3rd—Quality control samples and routine patient samples
2 Date and time the rack was loaded (first on, first processed)
3 Assay (depends on the assay protocol file [APF])
4 Sample position within the rack (in order from first position to tenth
position)
5 Maintenance routines
The system processes all STAT samples first, in the order you loaded them onto the
instrument. Next, the system processes calibration samples. Then, the system
processes routine patient samples and quality control samples with the same priority,
in the order you loaded them onto the instrument. Last, the system runs maintenance
routines.
NOTE
If a STAT patient sample has a requested test that is not calibrated, you must
calibrate the assay before you load and run the STAT sample.
Within a rack, the system typically processes all tests of a given type together to
maximize throughput. For example, the system will process all Cortisol tests
requested for samples in a rack, then all Thyroglobulin tests, and so on.
If your system is set up to automatically print reports, the result reports for patient
samples print when testing is complete, according to the priority criteria. For more
information about result reports, see Chapter 5: Test Results.
LIS Request When the system receives an LIS test request, it uses a set of rules to determine which
Container instrument and sample container it will assign the request to. If a test request is not
Assignment assigned to a sample container right away, the system stores it in the LIS workpool,
and the Work Pending button turns yellow. The test request in the LIS workpool can
be viewed on the Work Pending screen. When one of the rules is satisfied, the system
assigns the pending test request to the appropriate sample container.
NOTE
Be sure the appropriate tests are enabled. The system will reject an LIS test
request if the associated test is not enabled on at least one instrument in the
workgroup.
If the LIS interface is enabled (configured on), the Access 2 system is always open to
receive broadcast downloads of test requests. When a rack is loaded, the system
searches the LIS workpool for test requests for sample IDs scanned by the bar code
reader, and repeats the search every few seconds when in the Running mode.
You can also enable or disable host query for each instrument. If host query is
enabled, the Access 2 system can ask the LIS for new test requests, instead of waiting
for a broadcast. When a rack is loaded and the system finds no test requests in the
workpool for any of the loaded sample IDs, the system queries the LIS for test
requests. A test request received by host query is always assigned to the instrument
that generated the query, if the test is enabled.
The rules for assigning a test request to a sample container differ depending on:
• How many instruments are in the workgroup
• How many of the instruments in the workgroup have the test enabled
• How many sample containers exist for the sample ID
Before running requested tests, the Access 2 system does the following verifications
of supply quantities and expiration dates:
• Compares the requested tests to the number of tests that it can process with
the onboard substrate, reaction vessels (RVs), and reagent packs
• Compares the requested tests to the remaining capacity for RV waste
• Checks if there is wash buffer available and if there is remaining capacity for
liquid waste
• Checks the expiration dates of the substrate, reagent packs, reagent lots, and
calibrations
• Verifies that an active calibration exists for each of the tests requested
You can manage supply and calibration requirements in the following ways:
• Manually verify supply levels and calibrations at least once a day to be sure
the system can process all requested tests immediately when you start
processing.
• Request the system to verify supplies and calibrations after all of the tests are
requested (by you or the LIS), and before you select Run.
• Wait for the system to automatically verify supplies and calibrations after
you select Run. The Supplies Required button turns yellow if the system
requires supplies or calibrations.
If supply or calibration conditions are not OK for all of the tests requested, the system
processes the tests it can. The system does not schedule additional tests when the
current supplies are gone, calibrations are needed, or the waste containers are almost
full.
You can start sample processing using expired supplies or calibrations by overriding
current conditions. The system flags the results of tests using expired supplies or
calibrations in the Event Log and on result reports.
For more information about how to verify supply levels, load supplies, and change
waste containers, see Chapter 2: Supplies.
For more information about how to review calibrations, see Chapter 6: Assay
Calibrations.
For more information about how to enter calibration test requests, see
Chapter 3: Sample Management.
Supplies The Supplies Required screen lists any supplies or calibrations required to complete
Required the requested tests. You use this screen to:
Screen
• Load reagent packs and RVs Supplies
• Display the Reagent Inventory screen Required
Button
• Change the substrate bottle and the RV waste bag
• Print the Supplies Required Report
• Override certain supply and calibration conditions and
continue processing
0578A.bmp
To get to this screen from any screen, select the Supplies Required button.
0692A.bmp
Figure 4-5 Supplies Required Screen
Tests Requested (Field) Displays the total number of tests requested for onboard samples that have test
statuses of Requested or Supply Wait. The number includes reflex tests and tests
requested by the LIS.
Tests to Run (Field) Displays the number of tests requested for onboard samples that the system
can process with the current supply levels and active calibrations.
Required (Column) Displays the action or quantity needed.
• When a reagent is low or expired, displays number of packs (X Packs) needed.
• When RVs are low, displays the number of cartridges (X Cartridges) needed.
• When there is no calibration, displays Calibrate.
• When the calibration is expired, displays Recalibrate.
• When substrate is low or expired, the RV waste bag is full, or the wash buffer is
low, displays Change.
• When the liquid waste bottle is full, displays Empty.
• When no tests are requested or no supplies are needed, displays None.
Supply (Column) Displays the name of the supply required and the icon that represents the
supply. Supply names are: Substrate, RVs, RV Waste Bag, Wash Buffer, Liquid
Waste, and XXX, where XXX is the name of the reagent pack. For reagent packs with
primary and secondary tests, secondary tests display in parentheses after the reagent
pack name for the primary test. For example: Folate (RBC Folate).
Lot Number (Column) Displays the lot number associated with the supply condition, if applicable.
Otherwise, this column is blank.
Status (Column) Displays the calibration, lot, or substrate expiration status.
• When a reagent pack is expired, displays Pack Expired.
• When a reagent lot is expired, displays Lot Expired.
• When the substrate is expired, displays Expired.
• When there is no calibration, displays No Calibration.
• When the calibration is expired, displays Calibration Expired.
Load Reagent (Button) Select to load a reagent pack onto the instrument.
Pack F1 For information about loading reagent packs, see Chapter 2: Supplies.
Reagent (Button) Select to display the Reagent Inventory screen to see a list of onboard and
Inventory F2 unloaded reagent packs.
For information about the Reagent Inventory screen, see Chapter 2: Supplies.
Load RVs F4 (Button) Select to load RVs.
For information about loading RVs, see Chapter 2: Supplies.
Change (Button) Select to change the substrate bottle. You cannot change the substrate bottle
Substrate F5 when the system is in the Running mode.
For information about changing the substrate bottle, see Chapter 2: Supplies.
Requesting Before starting sample processing, you can display the Supplies Required screen to
Verification of get detailed information about any supply and calibration conditions that will prevent
Supplies and the processing of new tests.
1. Go to the Supplies Required screen. To get to this screen from any screen, select
the Supplies Required button.
The system compares the number of tests requested to the number of tests that it can
process with the onboard supplies and the remaining capacity for liquid waste and
used RVs. The system also verifies the status of all requested assay calibrations and
checks the expiration dates of calibrations, reagent packs, reagent lots, and substrate.
The screen lists the actions or quantities needed.
Overriding You can start sample processing using expired calibrations, substrate, reagent packs,
Supply Condi- or reagent lots by overriding the current conditions. The system applies appropriate
tions flags to test results and logs a corresponding event in the Event Log.
You can also override a reagent pack that is not calibrated, but test results will not be
generated for the assay.
NOTE
If you are recalibrating an expired calibration and running STAT tests for the
assay at the same time, you must override the expired calibration. Until you select
Override F8, the STAT test requests stay in the Supply Wait status.
1. Go to the Supplies Required screen. To get to this screen from any screen, select
the Supplies Required button.
(Optional) To override some supply conditions but not others, first correct the
conditions you do not want to override.
For example, you may have an expired Thyroglobulin reagent pack and a Cortisol
pack with an expired calibration, and you only want to override the Cortisol
calibration. You unload the expired Thyroglobulin pack and load an unexpired
Thyroglobulin pack. You then return to the Supplies Required screen and perform the
override procedure. Cortisol will be removed from the list on the Supplies Required
screen and the subsequent Cortisol test results will be flagged.
NOTE
If the system is in the Running mode, you do not need to select Run. The system
pauses briefly and then runs the tests, using overridden expired supplies or
calibrations.
The Access 2 system removes the overridden expired supplies or calibrations from the
list on the Supplies Required screen. If no other supplies are required, the system will
continue the run and flag the tests that use the expired supplies or calibrations.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Supplies Required Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith
S/N 500135
Tests Requested 36
Tests to Run 0
Page 1 of 1
Technologist ________________________ Printed 04/04/11 03:16 PM
0823D.bmp
Figure 4-7 Supplies Required Report
The Access 2 system verifies that all necessary samples are onboard while scheduling
tests.
When the system requests a reflex test, accepts a downloaded LIS test request, or
when you rerun a test, the system tries to find the sample onboard any instrument in
the workgroup.
Tests that the system cannot schedule because it cannot find an onboard sample are
called work pending. When the system fails to find an onboard sample, the sample is
added to the work pending list, and the Work Pending button turns yellow. You must
either load the appropriate sample or delete the test request using the Delete F6 button
on the Work Pending screen.
Work Pending only lists test requests for tests that are enabled on the instrument
attached to the PC displaying the Work Pending screen. These test requests can
originate from any system in the workgroup.
Because the system automatically deletes manually entered, unscheduled test requests
if you unload and clear the sample, the system never displays manually entered test
requests in the work pending list.
For information about reflex tests, see Chapter 4: System Configuration in the
Reference Manual.
For information about rerunning tests with fatally flagged results, see Chapter 5: Test
Results.
You access the Work Pending screen from the Sample Manager screen or from any
screen by selecting the Work Pending button.
0700B.bmp
Figure 4-8 Work Pending Screen
Filter (Field) Displays the filter and sort order that is currently in effect.
Samples (Field) Displays the number of samples the system needs in order to complete the
Requested requested tests.
LIS Workpool (Field) Displays the number of samples in the LIS Workpool. The workpool is a
list of tests that have been requested by the LIS, but that the system cannot
schedule because the associated samples are not onboard any instrument in the
workgroup.
Sample ID (Column) Displays the sample ID of the requested sample.
Patient ID (Column) Displays the patient ID, if one exists, for the requested sample.
NOTE
A patient ID is required for LIS test requests.
Requested (Column) Displays the date and time that the sample was requested.
Tests Pending (Column) Displays the test names of all tests that are pending for the sample.
Origin (Column) Displays the origin of the test request. Values are: Reflex, LIS, Manual
(Rack/Instrument) Rerun.
In parentheses, displays the rack ID and the instrument name the associated with
the sample. If the sample is not associated with a rack, the rack is blank. If the
sample was never loaded on an instrument, the instrument is Unknown.
Filter F1 (Button) Select to display the Filter window and apply a filter and a sort order to
the Work Pending screen.
For more information about the Filter window, see the Applying a Filter to Work
Pending procedure.
Sample (Button) Select to display the Sample Manager screen to see a list of racks, to load
Manager F2 a rack, or to add a sample to an onboard rack.
For more information about loading samples and racks, see Chapter 3: Sample
Management.
Delete F6 (Button) Select to display the Delete window and delete tests from the work
pending list.
For more information about the Delete window, see the Deleting Work Pending
Tests procedure.
Print F7 (Button) Select to print the Work Pending Report.
For more information about the Print window, see the Printing Work Pending
procedure.
Applying a Fil- A work pending filter is a set of parameters you can change to reduce or expand the
ter to Work number of samples displayed on the Work Pending screen.
Pending Use this procedure to apply a different filter to the Work Pending screen.
1. Go to the Work Pending screen. To get to this window from any screen, select the
Work Pending button.
0826B.bmp
Figure 4-10 Filter (Work Pending) Window
• To include off-board samples with pending rerun tests, select the Off-board
Manual Rerun box.
• To include off-board samples with pending LIS test requests, select the
Off-board LIS Requests box.
(Optional) Select or clear the Ascending box to sort the samples in ascending or
descending order.
4. Select OK F1.
The system displays all the samples with tests that meet the selected filter parameters
on the Work Pending screen.
NOTES
• The system uses the selected filter until you apply a different one.
• The Work Pending button turns yellow only when a pending test that fits the
filter criteria is added to the work pending list.
Deleting Work Use this procedure to delete selected tests or all tests from the Work Pending screen.
Pending Tests
1. Go to the Work Pending screen. To get to this screen from any screen, select the
Work Pending button.
3. Select OK F1.
A confirmation window is displayed.
Printing Work Use this procedure to print a list of samples associated with pending test requests.
Pending
1. Go to the Work Pending screen. To get to this screen from any screen, select the
Work Pending button.
Laboratories, Inc.
Laboratory A
123 Lake
Street
Access 2 Immunoassay System Townsville, ST 33333
Work Pending Report 101-555-2323 ext. 109
S/N 501240 Jane Smith
‘
Page 1 of 1
Technologist ______________________________________ Printed 10/10/11 11:05 PM
0824D.bmp
Figure 4-12 Work Pending Report
You can monitor sample progress by looking at the rack status, sample status, or test
status:
• Rack Status
Progress of all samples on a rack.
• Sample Status
Progress of individual samples.
• Test Status
Progress of requested tests.
Rack Status You can monitor the testing progress of an entire rack by looking at the rack status,
displayed on the Sample Manager screen. The system displays the rack status in the
center of the rack button in the On Board or Off Board list.
The rack status depends on the progress of each sample in the rack. After the rack
reaches the status of Requested, the sample in the earliest stage of testing determines
the status. For example, if nine samples in a rack are In Progress but the tenth sample
is Requested, the rack status is Requested.
You can use the rack status to determine when you can unload a rack from the
instrument. You can unload a rack with the Aspirated status without affecting testing,
unless a reflex test is requested after aspiration is complete. If you attempt to unload a
rack before the Aspirated status, the system displays a confirmation window before
you can unload it.
If a reflex test begins processing, the rack status can revert to an earlier status. For
more information about reflex testing, see Chapter 4: System Configuration in the
Reference Manual.
For more information about the Sample Manager screen, see Chapter 3: Sample
Management.
No Tests The rack is empty or has samples associated with it, but none
of the samples has requested tests.
Requested At least one test has been entered or downloaded for at least
one sample in the rack.
Supply Wait At least one test requested for at least one sample in the rack
requires you to load supplies or calibrate assays before it can
run.
In Progress All tests requested for all samples in the rack have been
scheduled for processing.
The Asp. and Comp. fields replace the rack status. The Asp.
field displays the estimated time until aspiration is complete
and the Comp. field displays the estimated time until all
processing is complete for the rack.
If the rack is being used for a maintenance routine, the Asp.
and Comp. fields are displayed as applicable.
Aspirated All tests requested for all samples in the rack have been
pipetted. You can remove the rack without affecting
processing, unless a reflex test is requested after aspiration is
complete.
The Asp. field displays Done, and the Comp. field displays
the estimated time until all processing is complete for the
rack.
Done All tests requested for all samples in the rack have been
processed. The Done rack status replaces the Asp. and Comp.
fields.
*Done* All tests requested for all samples in the rack have been
processed, but at least one test was cancelled. The *Done*
rack status replaces the Asp. and Comp. fields.
Sample Sta- For an individual sample, you can monitor sample progress by looking at the Status
tus column on the Test Requests screen. For more information about the Test Requests
screen, see Chapter 3: Sample Management.
Test Status You can monitor individual test status by looking at the Result column on the Test
Results screen. During test processing, the system displays the test status instead of a
result in this column. For more information about this screen, see Chapter 5: Test
Results.
Table 4-15 Test Status Descriptions for the Test Results Screen
5 Test Results
5.1 Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Specifying a Date and Time Range for a Test Result Filter . . . . . . . . . . . . . 5-20
Test results are data the Access 2 system creates and stores for every test the system
runs. As the system completes sample processing, the test results become available
for you to review, manage, and print. Test results include:
You can review the test results on the Test Results screen, or print the test results in
one of several report formats.
You use the function buttons on the screen to perform these procedures:
For more information about filters, see Section 5.2: Reviewing Test Results.
0591B.wmf
Figure 5-1 Test Results Flowchart
You access the Test Results screen from the Main Menu.
0627D.bmp
Figure 5-2 Test Results Screen
LIS (Optional column) Displays the LIS status of the test result.
Values are:
• <blank> - Either the system has not calculated the result, or the result will not be
sent to the LIS.
• Sending - The system is sending the result to the LIS.
• Accepted - The system sent the result and the LIS received it.
• Failed - The system sent the result, but the LIS did not receive it.
• Idle - The system attempted to send the test result to the LIS while the global
LIS interface was offline.
RLU (Optional column - not shown) Displays the actual RLUs for the test result.
Instrument (Optional column - not shown) Displays the ID of the instrument that ran the test.
Verify (Optional column - not shown) Displays the status of the test results. When the LIS
is set up to send only auto-verified results to the LIS, the system compares the test
results to the LIS ranges you defined. For more information, see Section 4.9: LIS
Setup. Also see Section 4.7: Ranges Setup in the Reference Manual. Values are:
• <blank> - The system has not compared the test result to the set LIS ranges. If
the column is blank, it usually means the result has not been calculated yet.
• Pass - The test result was within the set LIS ranges. The system sent the result
to the LIS.
• Fail - The test result was not within the set LIS ranges and the system cannot
send it to the LIS. The system displays the word Fail in red.
• Not Verified - The LIS is not set up to verify results.
Pipettor (Optional column - not shown) Displays N/A. This column is reserved for future
use.
Filter F1 (Button) Select to apply, edit, or delete filters and sort orders to the Test Results
screen. The system displays the selected filter and sort order in the Filter field.
For information about test result filters, see Section 5.2: Reviewing Test Results.
Find F2 (Button) Select to search the filtered results for a specific test result.
Rerun Test F3 (Button) Select to re-request the selected test. If the sample is onboard an
instrument, the test is automatically assigned and runs at the next opportunity. If
the sample is not onboard, the system displays it on the Work Pending screen (see
Chapter 4: Sample Processing for more information on Work Pending).
Sample Details F4 (Button) Select to display demographic information, comments, and flag
interpretations for the sample.
Send to LIS F5 (Button) Select to send test results to the LIS.
Copy to Disk F6 (Button) Select to copy all test results or selected test results to a disk or USB flash
drive. For more information, see the Copying Test Results to Disk or USB Flash
Drive procedure.
Print F7 (Button) Select to display a menu of the following options:
Report F1 – Select to print test result reports.
Selecting Test Use this procedure to select one or more test results on the Test Results screen.
Results
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
2. Select a test result by selecting the row. An arrow displays at the beginning of the
selected row.
NOTES
• Use the scroll bar on the right side of the screen to view the results that are
out of the normal viewing range.
• Press the [Ctrl] key while you press the [Home] or [End] key to go to the
beginning or end of the test result list, respectively.
(Optional) Select a different row by touching it. The arrow displays at the new
row you selected and is cleared from the previous selection.
(Optional) To make multiple selections, you use the [Ctrl] or [Shift] key.
To select test results that are not contiguous, press the [Ctrl] key while you select
multiple rows. For example, press the [Ctrl] key and then select 3 results. Each of the
rows is selected.
To select contiguous test results, press the [Shift] key while you select the first and
last of the contiguous rows. For example, to select the first 5 results, press the [Shift]
key and then select the first and fifth results. Release the [Shift] key. All five results
are selected.
(Optional) To remove one result from multiple selected results, press the [Ctrl]
key while you select the middle of the row with the result. The result is no longer
selected.
When test results become available, you can review them. The system displays test
results for all samples currently onboard the instrument and sorts them by sample ID,
then by test name. This is the default filter the system applies to the test result data.
You can limit the number of test results that display on the screen by applying a
different filter. You can also choose the columns you want to display and customize
the column order.
You can find a specific test result using the sample ID, patient ID, rack ID, or test
name.You can also view test result flags and descriptions. Flags are codes the
Access 2 system associates with test results when a special circumstance requires
attention.
When reviewing results for a particular sample, you can rerun any tests on that
sample.
Test Result A test result filter is a set of parameters you can manipulate to limit the number of
Filters results displayed on the Test Results screen to only those you want to see at any given
time.
The Test Results screen is always filtered. The default filter from the Main Menu is
All Samples (Last 30 Days) - Sorted by Sample ID Then by Test Name.
The system displays the test results based on the filter parameters. You can adjust the
number and type of test results displayed by selecting a different system-defined
filter, defining a new filter, or editing the parameters of one of your laboratory’s
defined filters.
You define a new filter by determining all of the parameters for the filter. For
example, you can create a filter that only displays patient samples with a sample ID
that begins with the digits 1234.
You can also edit the laboratory-defined filter parameters to display different test
results, or you can use a system-defined filter as a basis for creating a new filter. For
example, you can select the system-defined All Patient Samples (Last 30 Days)
filter, change the parameters, and save the filter with a new name.
When you change any of the parameters of a filter, you can either save the changes as
a new filter or apply the changes without saving them. If you do not save the changes,
the system retains the unnamed filter only until you apply a different one. You would
have to redefine the filter to use it again.
The last filter you apply becomes the default filter for the next time you display the
Test Results screen. The Access 2 system automatically uses that default filter until
you apply a new one or until the system is rebooted.
A sort order determines the order test results are listed in, and you can include both
primary and secondary sort orders in a filter. For example, you can sort test results by
Sample ID, then by Completion Time in ascending order.
Applying a
Test Result
Main Menu
Filter
Test Results
F2
Test Results
Filter
F1
Filter
Select filter
and sort orders
OK
F1
0522A.wmf
Figure 5-4 Applying a Test Result Filter
Use this procedure to apply one of the available test result filters. The following test
result filters are system-defined:
1. Go to the Filter window. To get to this window from the Main Menu, select Test
Results F2 to display the Test Results screen, then select Filter F1.
2037A.bmp
Figure 5-6 Filter (Test Results) Window
(Optional) To change the sort order, select a 1st and 2nd Sort Order option.
(Optional) To display the results in descending order, clear the Ascending box.
3. Select OK F1.
NOTE
If you selected the system-defined filters All Patient Samples Loaded
Between... or All Samples Loaded Between..., or a laboratory-defined filter that
asks for the date and time, the system prompts you to enter the date range. For
more information, see the Specifying a Date and Time Range for a Test Result
Filter procedure.
The system displays all test results that meet the selected filter parameters on the Test
Results screen. The applied filter becomes the default filter until you apply a different
saved filter.
Editing a Test
Result Filter Main Menu
Test Results
F2
Test Results
Filter
F1
Filter
Select filter
and sort orders
Filter Parameters
Edit Filter
F3 Filter Name
Description
Ask for Date & Time
Edit Filter Instruments
Test Result Status
LIS State
Sample ID
Edit filter parameters
Test Name
Auto-Verify
Rack ID
Patient ID
Result
Population
Filter
Clear Parameters
F3
No parameters
OK?
Yes
OK
F1
No Cancel
F4
No Save Filter? No F8
OK
F1
0647B.wmf
Figure 5-8 Editing a Test Result Filter
Use this procedure to edit an existing filter and apply it to the Test Results screen.
NOTE
If you change the system ID for an instrument in your workgroup, the instruments
selected in the existing filters may also change. Test and update the filters to
make sure they operate as expected.
1. Go to the Filter window. To get to this window from the Main Menu, select Test
Results F2 to display the Test Results screen, then select Filter F1.
2. Select the filter you want to edit from the Filter list.
The system displays a description of the filter in the Description field and the default
sort orders in the 1st and 2nd Sort Order columns.
0605B.bmp
Figure 5-9 Edit Filter (Test Results) Window
Filter Name (Field) Displays the name of the filter selected in the Filter
window. You can delete the name and type a new name.
Description (Field) Displays the description of the filter selected in the
Filter window. You can delete the description and type a
new description.
Ask for Date and (Box) Select to have the system ask for date and time
Time parameters each time you apply the filter.
To set the date and time, see the Specifying a Date and
Time Range for a Test Result Filter procedure.
Instruments (Boxes) Select the instrument(s) to include in the filter. If
your Access 2 system is connected to a workgroup, there
could be up to 4 systems to choose from.
Test Result (Boxes) Select the test result statuses to include in the
Status filter.
LIS State (List) Select to include the status of the LIS in your filter.
Values are:
• All
• Idle
• Sending
• Failed
• Accepted
• Not Sent
Sample ID (List) Select the sample IDs to include in the filter. In the
first field, select a relationship from the list.
Values are: all, =, <, >, <=, >=.
In the second field, enter a sample ID value.
Test Name (List) Select the enabled tests to include in the filter. The
list contains all enabled test names.
Auto-Verify (List) Select the status of the test results to include in the
filter.
Values are: Pass, Fail, Not Verified, or All results.
Rack ID (List) Select the rack IDs to include in the filter. The list
contains all racks defined in the database.
Patient ID (List) Select the patient IDs to include in the filter. In the
first field, select a relationship.
Values are: all, =, Begins With, Ends With, Contains.
In the second field, enter a patient ID value.
4. Enter the information and select or clear boxes and options to define the
parameters for the filter.
5. Select OK F1.
The system prompts you to save the filter.
NOTE
If you are editing one of the system-defined filters, you must save it as a different
name.
(Optional) To continue without saving changes to the filter, select No F4. The
system applies the filter.
(Optional) To continue without saving the filter, select Cancel F8. The system
does not save or apply the filter.
Defining a
New Test Main Menu
Result Filter
Test Results
F2
Test Results
Filter
F1
Filter
Yes
OK
F1
No
F4
No Save Filter?
OK
F1
0610B.wmf
Figure 5-11 Defining a New Test Result Filter
Use this procedure to define a new filter and apply it to the Test Results screen.
1. Go to the Filter window. To get to this window from the Main Menu, select Test
Results F2 to display the Test Results screen, then select Filter F1.
3. Enter information and select or clear the boxes and options to define the
parameters for the new filter.
NOTE
Every new filter has the default sort orders Sample ID and Test Name.
(Optional) To change the sort orders, select OK F1 and select new sort order
options.
(Optional) To save and apply the filter, select Yes F1 to display the Save As
window. Enter a name for the filter in the Save Filter As field, then select OK F1.
If the filter requires a date or time range, the Specify a Date Range window is
displayed. Select the appropriate ranges or enter information in the fields, then select
OK F1. For more information, see the Specifying a Date and Time Range for a Test
Result Filter procedure.
The system displays the test results that meet the filter parameters on the Test Results
screen.
(Optional) To apply a filter without saving it, select No F4. The unnamed filter
remains the default filter until you apply a different one.
The system displays the test results that meet the filter parameters on the Test Results
screen.
Deleting a Use this procedure to delete any new or edited filters. You cannot delete
Test Result system-defined filters.
Filter 1. Go to the Filter window. To get to this window from the Main Menu, select Test
Results F2 to display the Test Results screen, then select Filter F1.
3. Select Delete Filter F4. This button is unavailable for system-defined filters.
The system displays a confirmation message.
5. Select Cancel F8 to exit the Filter window without changing the applied filter.
Specifying a Use this procedure to specify date and time parameters when applying a test result
Date and Time filter that asks for date and time ranges.
Range for a 1. Go to the Filter window. To get to this window from the Main Menu, select Test
Test Result Results F2 to display the Test Results screen, then select Filter F1.
Filter
2. Select a filter that requires you to specify a date and time range (the Ask for Date
and Time box was selected when the filter was defined).
0927B.bmp
Figure 5-12 Specify a Date Range (Test Results Filter) Window
Date and (Options and field) Select one of the following options to
Time Range display the test results from that date range:
• Past 24 hours (Option) - Select to display all of the test
results that were obtained in the past 24 hours and fit the
filter criteria
• Past 7 days (Option) - Select to display all of the test results
that were obtained in the past 7 days and fit the filter criteria
• Past # days (Option) - Select to display all of the test results
that were obtained during the days you enter and that fit the
filter criteria
• Past # hours (Option) - Select to display all of the test
results that were obtained in the past number of hours you
enter and that fit the filter criteria
• (Field) - If you select one of the options with a # sign, enter a
number.
Table 5-13 Specify a Date Range (Test Results Filter) Window Descriptions
Specify Date (Option and fields) Select the Date and Time Range option
and Time and specify the starting and ending dates and times in the
Range fields.
Table 5-13 Specify a Date Range (Test Results Filter) Window Descriptions
4. Select a Date and Time Range option, or select the Date and Time Range
option.
If you select the Date and Time Range option, enter the starting and ending dates and
the starting and ending times in the appropriate fields.
NOTE
The date format follows the format you set up on the System Setup screen. The
system displays a message if the incorrect format is used. For more information
about setting the date format, see Chapter 4: System Configuration in the
Reference Manual.
Finding a Test
Result
Main Menu
Test Results
F2
Find
F2
Find
(Optional)
Select a search
direction, up or down
Find Next
F1
Result(s)
selected? No
Yes
Cancel
F8
0520B.wmf
Figure 5-14 Finding a Test Result
Use this procedure to search filtered results for a specific test result.
NOTE
This procedure will only find test results that fit the filter criteria. If you are
having difficulty finding a specific test result, apply a different new filter.
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
0609A.bmp
Figure 5-15 Find (Test Result) Window
Sample ID (Field) Enter the sample ID of the result you want to find.
Rack ID (Field and List) Enter or select the rack ID of the result you
want to find.
Patient ID (Field) Enter the patient ID of the result you want to find.
Test Name (Field and List) Enter or select the test name of the result
you want to find.
Direction (Option) Select Up or Down to change the direction of the
search. If you select Down, the system begins the search at
the current result and continues down the list. If you select
Up, the system begins the search at the current result and
continues up the list.
When a search reaches the top or bottom of the list, the
search continues from the opposite end.
Find Next F1 (Button) Select to find the next result included in the filter
that fits the search criteria.
3. In the appropriate field, enter information for the sample you want to find.
• For the Sample ID field, you do not need to enter complete information in the
field. For example, if you are searching for sample ID 123456789, enter 1234.
The system will select the first sample ID starting with 1234.
• For Rack ID and the Test Name you can enter a number or pick a number from
the list
(Optional) To change the direction of the search, select the Up or Down option.
If you select Down, the system begins the search at the current result and continues
down the list. If you select Up, the system begins the search at the current result and
continues up the list. When a search reaches the top or bottom of the list, the search
continues from the opposite end.
4. Select Find Next F1. The closest match to the search parameters you entered
becomes the selected result.
NOTES
• If the system does not find a match, the system displays a message in the
status line.
• If any of the filtered results have been deleted, a message displays that directs
you to refresh the screen. To refresh the screen, select More Options F8 and
then select Refresh Screen F1. Repeat step 4.
(Optional) To find the next result that fits the search criteria, select Find Next F1.
Rerunning a Use this procedure to rerun a test. If the sample is onboard an instrument, the system
Test automatically assigns the test and runs it at the next opportunity. If the sample is not
onboard, the system assigns it to the instrument and displays it on the Work Pending
screen (see Chapter 4: Sample Processing in this manual).
NOTE
You can only rerun tests for patient and quality control samples. To rerun tests for
other kinds of samples, request the tests again.
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
(Optional) To locate a specific test result associated with the sample, select Find
F2. For information about how to do this, see the Finding a Test Result procedure.
Viewing Sam-
ple Details
Main Menu
Test Results
F2
Select a single
test result
Sample Details
F4
Details
Review sample
demographic
information and flag
explanations (if any)
OK
F1
0643B.wmf
Figure 5-17 Viewing Sample Details
Use this procedure to view details about the sample the result is associated with,
including demographic information, comments, and result flag explanations (if
applicable).
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
(Optional) To find a specific test result, select Find F2. For information about
how to do this, see the Finding a Test Result procedure.
0747C.bmp
Figure 5-18 Sample Details Window
Patient ID (Field) Displays the patient ID, if one exists, for the patient
sample. This demographic information is sent from the
LIS.
First Name (Field) Displays the first name of the patient that is
associated with the sample. This demographic information
is sent from the LIS.
Last Name (Field) Displays the last name of the patient that is
associated with the sample. This demographic information
is sent from the LIS.
Sex (Field) Displays the sex of the patient that is associated
with the sample. This demographic information is sent
from the LIS.
Birth Date (Field) Displays the birth date of the patient that is
associated with the sample. This demographic information
is sent from the LIS.
Doctor Name (Field) Displays the doctor’s name that is associated with
the patient sample. This demographic information is sent
from the LIS.
Sample ID (Field) Displays the sample ID of the patient sample.
Sample Type (Field) Displays the type of fluid in the sample container.
Dilution (Field) Displays the dilution factor of the patient sample.
Test Name (Field) Displays the name of the test that was run on the
patient sample.
Reference Range (Field) Displays the reference range used for the test. The
reference range is defined in the ranges windows (see
Section 4.7: Ranges Setup in the Reference Manual).
Result (Field) Displays the results of the test run on the sample.
Sample (Field) Displays any comments entered about the sample.
Comment
Flags (List) Displays the flags applied to the result and a
description of each flag.
Troubleshoot F2 (Button) Displays troubleshooting Help about flags.
NOTE
This button is unavailable for results without flags.
4. Select OK F1.
Test Result If something occurs while a test is running or if the system needs supplies, the system
Flags associates a flag to the sample.
You can use the Sample Details window to read a description of the flags associated
with a particular result. You then select Troubleshoot F2 to find troubleshooting
information about each flag.
For the result flag description and troubleshooting information, see Section A.4:
Assay Troubleshooting in the Reference Manual.
Configuring
the Test
Results Main Menu
Screen
Test Results
F2
Test Results
More Options
F8
Configure Screen
F2
Configure Screen
OK
F1
0611B.wmf
Figure 5-20 Configuring the Test Results Screen
Use this procedure to change the columns and rearrange the order of the columns
displayed on the Test Results screen. The system displays the following default
columns for all filters except for the Failed Auto-Verify and Not Sent to LIS filter:
• Patient ID • Result
• Sample ID • Completion Time
• Rack • Flags
• Test Name • LIS
For the Failed Auto-Verify and Not Sent to LIS filter, the system displays the Verify
column and does not display the Patient ID column. You can change the default
column configurations for any filter.
1. Go to the Test Results screen. To get to this window from the Main Menu, select
Test Results F2
Column Order
Buttons
0602A.bmp
Figure 5-21 Configure Screen (Test Results) Window
Column Order (Row) Displays the columns currently included on the Test
Results screen and in their respective order.
Optional (Boxes) Select the optional columns to include on the Test
Columns Results screen.
For more information about these values, see Table 5-3.
Column Order (Buttons) Select the right or left arrow button to rearrange
Buttons the columns in the Column Order row.
4. In the Optional Columns list, select the additional columns you want to include
from the following column options: Patient ID, Rack, Verify, Comp. Time, LIS,
Instrument, RLU, Pipettor.
You can add optional columns, depending on the combination of columns, until you
reach the maximum width of the screen.
(Optional) To rearrange the order of the columns, select a column and use the
right and left arrow column buttons to move it.
You can select a column from the Column Order row before selecting an arrow
button to move that column right or left. If you do not select a column, before
selecting an arrow button, the first column is selected by default.
5. Select OK F1.
The Test Results screen displays the new options you selected.
For help in managing your test results, you can use the Access 2 system to:
• Send test results to the LIS
• Copy test results
• Delete test results
If you are using an LIS, the system automatically sends the test results with their
associated flags to the LIS when sample processing is complete.
NOTES
• Tests results with fatal flags are not sent to the LIS automatically nor can
they be sent manually.
• For a list of circumstances that require you to manually send test results to
the LIS, see the Sending Test Results to the LIS procedure.
You can copy selected test results or all test results to a high-density, 3.5-inch
DOS-formatted disk or a USB flash drive.
NOTE
Copying test results does not remove them from the system database.
Deleting test results removes the data permanently from the system database.
For information about how to automatically transmit test results to the LIS and how to
enable host query of the LIS, see Chapter 4: System Configuration in the Reference
Manual.
Sending Test
Results to the
LIS
Main Menu
Test Results
F2
Test Results
Filter
Apply filter
and sort orders
Selected
Filter
results No F1
displayed?
Yes
(Optional)
Select a group of
results or a single result
Send to LIS
F5
Send to LIS
OK
F1
0644A.wmf
Figure 5-23 Sending Test Results to the LIS
Use this procedure to manually send test results to the LIS if one or more of the
following circumstances applies:
• The Auto Send to LIS option is set to Off or to Send Only Auto-Verified
Results. For more information about the Auto Send to LIS or Send Only
Auto-Verified Results options, see Section 4.9: LIS Setup in the Reference
Manual.
• The LIS fails to receive a transmission of test results.
• The test results were on hold while the LIS was off-line, and now it is back
on-line.
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
(Optional) To locate a group of test results to send to the LIS, apply a filter to
reduce the number of displayed results. For information about how to do this, see
the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test
Results.
(Optional) To locate a specific test result to send, select Find F2. For information
about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
2. Select a single test result or a group of results to send the LIS. For more
information about selecting test results, see the Selecting Test Results procedure
in Section 5.1: Test Results.
0626A.bmp
Figure 5-24 Send to LIS Window
Current (Option) Select to send the selected test result to the LIS.
Result
Current (Option) Select to send the one or more selected test results to
Selection the LIS.
Resend LIS (Option) Select to resend all of the test results with an LIS
Fail status of Fail to the LIS.
All (filtered (Option) Select to send all the test results in the current filter to
results) the LIS.
4. Select an option from the Send what list (based on your selection in step 2).
5. Select OK F1.
NOTE
If any of the filtered results have been deleted, a message displays that directs you
to refresh the screen. To refresh the screen, select More Options F8 and then
select Refresh Screen F1. Then repeat this procedure, beginning at step 2.
6. Monitor the transmission by viewing the statuses in the LIS column of the Test
Results screen.
• If the LIS successfully receives results, the LIS status changes to Accepted.
• If the LIS does not successfully receive the results, the LIS status changes to
Failed.
Copying Test
Results to Main Menu
Disk or USB
Flash Drive
Test Results
F2
Test Results
Filter
Apply filter
and sort orders
Correct set
Filter
of results No F1
selected?
Yes
Copy to Disk
F6
Copy to Disk
• Confirm or change
the file name
• Select a Copy What
option
Yes
(Optional)
Select Format disk
OK
F1
0645C.wmf
Figure 5-26 Copying Test Results to a Disk or USB Flash Drive
Use this procedure to copy test results to a 3.5-inch high-density, DOS-formatted disk
or a USB flash drive.
The Access 2 system writes the following data into a comma-separated field format
that you can import into a PC-based spreadsheet program:
NOTE
Copying test result data does not remove it from the database.
2. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
(Optional) To locate a group of test results to copy, apply a filter to limit the
number of results to include only the results you want to copy. For information
about how to do this, see the Applying a Test Result Filter procedure in
Section 5.2: Reviewing Test Results.
(Optional) To locate a specific test result to copy, select Find F2. For information
about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
3. Select a single test result or a group of results. For more information about
selecting test results, see the Selecting Test Results procedure in Section 5.1: Test
Results.
NOTE
Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the Access 2
instrument.
• To copy data to a USB flash drive, insert a flash drive into a port on the front
of the PC. If the front of the PC does not contain a USB port, use a port on the
back of the PC.
NOTE
For instruments set up to perform system backups using a USB flash drive, the
backup drive might already be in one of the USB ports on the back of the PC. Use
a different flash drive to copy data. Do not disturb the flash drive used for
backups when inserting and removing the flash drive for copying data.
2107B.bmp
Figure 5-27 Copy to Disk (Test Results) Window
File name (Field) Displays the default file name and extension of the test
result to be copied. You can delete the name and type a new
name.
Drive (List) For a USB flash drive, select the external computer drive
to which data should be copied.
Current (Option) Select to copy the selected test result.
Result
Current (Option) Select to copy one or more selected test results.
Selection
All (filtered (Option) Select to copy all the test results in the current filter.
results)
Format disk (Box) Select to format a 3.5-inch high density disk. Formatting
a disk prepares it for reading and writing data.
6. Enter a name and file extension for the data file in the File Name field.
• The system supplies a default file name based on the date and time and a .csv
(comma delimited) extension.
• If the file name already exists, the system displays a warning message. To
overwrite the existing file, select Yes F1. To rename the new file, select Cancel
F8.
(Optional) If your instrument has USB flash drive technology, confirm that the
correct drive is selected from the Drive list, or select a different drive.
NOTE
Unless directed by Technical Support, do not copy data to the C: Console PC
drive or any drive labeled BACKUPDRIVE.
(Optional) If the 3.5-inch disk is not formatted, select the Format disk box.
9. If the disk or flash drive becomes full before the copy process is complete, the
system displays a status message.
• For a 3.5-inch disk:
- Remove the disk from the drive. Label it with the data file name(s).
• For a USB flash drive, clear sufficient space on the drive, or copy the files to
a different flash drive.
10. When the copy process is complete, the system displays a status message.
11. Remove the disk or flash drive from the PC and label it.
NOTE
If you will be using one disk or flash drive to copy multiple files, you can leave it
in place for the next copy operation. Be sure to keep track of the file names so you
can correctly label the disk or flash drive when you remove it.
Deleting a
Test Result
Main Menu
Test Results
F2
Test Results
Find Filter
Yes
More Options
F8
Delete Data
F3
Password
Enter your
password
OK
F1
Delete Data
OK
F1
0646B.wmf
Figure 5-29 Deleting a Test Result
Use this procedure to permanently delete test results from the database. You need the
system password in order to delete test results.
CAUTION
Deleting test results removes the data permanently from the database.
2. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
(Optional) To locate a group of test results to delete, apply a filter to limit the
number of results displayed. For information about how to do this, see the
Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.
(Optional) To locate a specific test result to delete, select Find F2. For
information about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
3. Select a single test result or a group of results to delete. For more information
about selecting test results, see the Selecting Test Results procedure in
Section 5.1: Test Results.
5. In the Password field, enter the system password, then select OK F1.
For information about passwords, see Chapter 4: System Configuration in the
Reference Manual.
The Delete Data window is displayed.
7. Select OK F1.
8. The system displays a warning message.
9. Select Yes F1 to delete the selected results or Cancel F8 to stop without deleting
the results.
A progress window is displayed. The system deletes the test results from the system
database. Select Cancel F8 to stop the delete process at any time.
You can print test result data in report format. You can print reports manually, or use
the auto-print option on the Report Setup window to print STAT and continuous
sample reports automatically.
You can display and print the following test result reports:
Report Description
For information about how to apply a filter to test results you want to print, see the
Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.
For information about how to automatically print test result reports, see Chapter 4:
System Configuration in the Reference Manual.
Main Menu
Test Results
F2
Test Results
System Configuration
Is For information about how to
Are you
printing from
Continuous automatically print test result
Set up the Auto Print
a completed No Sample Report No option
reports, see Chapter 4: System
set to Configuration in the Reference
Filter run?
print? Manual.
Yes
(Optional)
Select a group of
displayed results
Print
F7
Report
F1
OK
F1
0519C.wmf
Figure 5-31 Printing Test Result Reports
NOTES
• If you print the Sample Report, the Patient Report, or the Selected Test
Results Report before the final results are calculated for a test, the test status
may print in the Result column of the report. For descriptions of the test
statuses, see the Test Status topic see Section 4.4: Monitoring Sample
Progress.
• The Continuous Sample Report only prints if you set up the Auto Print
option. If set to print, the report prints automatically when there are enough
test results to fill a page, when a STAT sample is complete, or when the run
is complete. To manually print the report for completed samples, use this
procedure. For information about how to set the Auto Print option, see
Section 4.2: System Setup in the Reference Manual.
• Demographic information including patient name, birth date, sex, and
doctor’s name can be changed from the LIS following the completion of a
test result. If the demographic information is changed after a Patient Report is
printed, a reprint of the report will contain the updated information.
• Results are displayed in bold text for the following conditions:
- Quantitative and Semi-Quantitative - For quality controls, if the results
are outside of the control range. For patient results, if the results are
positive, equivalent, reactive, outside of the reference range, or outside
either end of the calibration curve.
- Qualitative - If the results are reactive, confirmed, or associated with a
GRY flag.
• If information for a sample or patient continues on the next page, the sample
or patient ID prints at the top of the next page.
1. Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2. Then continue according to one of the following options:
2. Select a single test result or a group of test results that you want to print. For more
information about selecting test results, see the Selecting Test Results procedure
in Section 5.1: Test Results.
(Optional) To limit the number of results, you can apply a filter. For information
about filters, see the Applying a Test Result Filter procedure in
Section 5.2: Reviewing Test Results.
(Optional) To locate a specific test result, select Find F2. For information about
how to do this, see the Finding a Test Result procedure in Section 5.2: Reviewing
Test Results.
0623B.bmp
Figure 5-32 Print (Test Result Reports) Window
5. Select the type of report you want to print from the report list (see Table 5-30).
6. Select the appropriate option from the Print What list (based on your selection in
step 2).
7. Select OK F1.
The system sends the report to the printer. A progress window is displayed. Select
Cancel F8 to stop the print job at any time.
Laboratories, Inc.
Laboratory A
123 Lake
Street
Patient Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109 R. Goldman
**STAT**
Sample ID: 23345128Dil Sample Type: Plasma Dilution: 10
Test Name Result Ref. Range Flags Completed
CK-MB 939.0 ng/mL 0.000 - 4.000 10-10-10 08:18 PM
Comments: Sample slightly cloudy.
**STAT**
Sample ID: 23345128 Sample Type: Plasma
Test Name Result Ref. Range Flags Completed
CK-MB >293 ng/mL 0.000 - 4.000 OVR 10-10-10 07:30 PM
MYO(2) No Value 17.400-105.700 QNS 10-10-10 07:27 PM
MYO 60.04 ng/mL 17.400-105.700 10-10-10 07:27 PM
0660E.bmp
Figure 5-34 Patient Report
Laboratories, Inc.
Laboratory A
123 Lake
Street
Sample Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109 B. Beaulieu
**STAT**
Instrument: 501240
Test Name Result Ref. Range Flags Dilution Completed
CK-MB >293 ng/mL 0.000 - 4.000 OVR 1 10-10-10 07:30 PM
MYO(2) No Value 17.400-105.700 QNS 1 10-10-10 07:27 PM
MYO 60.04 ng/mL 17.400-105.700 1 10-10-10 07:16 PM
Instrument: 500135
Test Name Result Ref. Range Flags Dilution Completed
Free PSA% 16.6 1 10-08-10 02:45 PM
free PSA 1.58 ng/mL 1 10-08-10 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000 - 4.000 1 10-08-10 02:15 PM
Comments: Cloudy sample.
0748E.bmp
Figure 5-35 Sample Report
Laboratories, Inc.
Laboratory A
123 Lake
Selected Test Results Report Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 V. Flores
0749D.bmp
Figure 5-36 Selected Test Results Report
0661Ea.bmp
Figure 5-37 Continuous Sample Report
6 Assay Calibrations
6.1 Assay Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
NOTE
Regardless of the type of calibration, the system reports the calibration with either
a quantitative curve or a qualitative cutoff, according to the parameters defined in
the assay protocol file (APF).
When you run calibration samples, the system evaluates the test results using
acceptance criteria defined by the APF. The calibration either passes or fails.
The system requires an active calibration for each requested test. If the calibration for
the requested test has not been performed or is expired, the system prompts you to
perform a calibration. If you process samples with an expired calibration, the system
flags the test results. If a new calibration fails, the system calculates the test results
using the previous active calibration.
For information about how to enter calibration test requests, see Chapter 3: Sample
Management.
For information about reviewing test results and result flags, see Chapter 5: Test
Results.
For help on how to interpret rejected calibrations, see Appendix A: Troubleshooting
in the Reference Manual.
For information about calibration theory and qualitative or quantitative assays, see
Chapter 3: Theory of Operation in the Reference Manual.
0521A.wmf
Figure 6-1 Calibration Flowchart
0766C.bmp
Figure 6-2 Calibration Screen
Calibration (Buttons) Displays the assay calibrations that meet the filter criteria and have run
Buttons on the instrument you are using. If there are more than 32 calibrations, use the
scroll bar to view all of the calibrations.
You select a calibration button if you want to review or delete calibration data.
Each button displays the following identifying information:
• Calibration name
The name of the assay that is calibrated.
• Reagent lot
The reagent lot number used for the assay calibration.
NOTES
• Calibration buttons only exist for calibrations that have run. If you want to
review the calibrators that are configured for the workgroup, select
Calibrator Setup F5.
• You can choose a button by touching it, selecting it with the mouse, or by
using the [Tab] key.
Filter F1 (Button) Select to modify the applied filter or the sort order.
NOTE
If you are using the scroll bar on the Calibration screen, scroll to the top of the
screen before applying a filter. If you do not scroll to the top, the results of the
applied filter may not be displayed. You will then need to exit the screen,
return to the screen, and apply the filter again.
Review Data F2 (Button) Select to display the Calibration Data screen for a selected calibration
button. You can view the active curve or cutoff from this screen. If there is no
active calibration (no calibration has passed), the system displays the last
calibration that has been run.
Calibrator Setup (Button) Select to go to the Calibration Setup screen. You can set up the
F5 calibrators, edit existing calibrators, or delete calibrators from this screen for all
instruments in the workgroup.
Delete F6 (Button) Select to delete a selected calibration button. The calibration button is
removed from the Calibration screen.
For information about deleting calibrations, see the Deleting Calibrations
procedure.
Print F7 (Button) Select to print the calibration report, which lists all the calibrations for the
instrument.
For more information about how to print a report, see Section 6.3: Calibration
Reports in this chapter.
Applying a Use this procedure to apply a filter to the calibration buttons on the Calibration screen.
Calibration You can choose a filter and specify the direction of the sort order.
Filter NOTE
If you are using the scroll bar on the Calibration screen, scroll to the top of the
screen before applying a filter. If you do not scroll to the top, the results of the
applied filter may not be displayed. You will then need to exit the screen, return
to the screen, and apply the filter again.
1. Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
850C.bmp
Figure 6-4 Filter (Calibration) Window
Filter (Options) Select either the filter that displays all assay
calibrations or the filter that displays only those assay
calibrations with reagent onboard the instrument.
4. Select the Ascending box if you want the system to display the calibrations in
ascending, alphabetic order (A - Z). If you want to display the calibrations in
descending, alphabetic order (Z - A), leave the box blank.
NOTE
The calibrations are sorted by test name, then by reagent lot.
5. Select OK F1.
The system applies the filter and displays the results on the Calibration screen.
Deleting Cali- Use this procedure to delete the stored data for an assay calibration and reagent lot.
brations You would delete a calibration that is expired or one that you do not use anymore.
NOTE
You cannot delete the calibration data if the instrument is in the Running or
Paused mode.
1. Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
2. Select the button for the assay calibration and reagent lot you want to delete.
4. Select OK F1.
The calibration and all of the stored data associated with the reagent lot listed on the
button are deleted from the instrument.
The system creates and stores calibration data for each calibration you run. Depending
on the type of assay calibration, the system generates an associated calibration curve
or cutoff. You can view this information and print it in a report format.
Calibrations using different reagent pack lots can be run for the same assay. When
reviewing calibration data, be sure to select the calibration button and the reagent
pack lot number of the calibration you want to view.
General calibration data includes:
• Selected assay and reagent pack lot number
• Calibrator lot number
• Calibration pass or fail status
• Date and time the calibration was run
• Expiration date and time for the calibration
• Test results
You can also view the associated calibration curve or cutoff. A calibration curve plots
the measured RLUs of each replicate versus the concentration of analyte. Calibration
cutoffs show the acceptance limits for individual replicates and for the mean of the
replicates.
Stored Cali- For calibrations with a cutoff, the system stores calibration data for the active and last
bration Data run calibrations. For calibrations that produce a curve, the system stores calibration
data for the active, previous active, and last run calibrations. You view stored data on
the Calibration Data screen.
Active The most recent calibration that passed, unless you switch it with
the previous active calibration.
Active calibrations are used to evaluate patient samples.
Previous The calibration that was previously the active calibration. You
Active can switch the previous active calibration with the active
calibration.
Last Run The results of the most recent calibration test request that either
passed or failed.
If the last run calibration passes, it also becomes the active
calibration.
You access the Calibration Data screen from the Main Menu.
NOTE
The format of the Calibration Data screen varies by whether the calibration
results are expressed with a cutoff (qualitative) or with a curve (quantitative).
Both formats and their screen descriptions are included below.
0768B.bmp
Figure 6-7 Calibration Data Screen (Cutoff)
0769C.bmp
Figure 6-8 Calibration Data Screen (Curve)
NOTE
If a result does not meet the acceptance criteria, it is not included in the
calculation of the mean.
Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions (continued)
Data Table • %CV: The percent coefficient of variation for the calibrator replicates.
(continued) • Result (Cutoff only): The interpretation of the test as reactive or non-reactive,
based on the generated cutoff.
NOTE
Confirmed or Not Confirmed is displayed for confirmatory assays (a numeric
result is not applied).
• Calculated Conc. (Curve only): The actual concentration calculated for the
calibrator tested and plotted on the curve. Values larger than ten digits are
displayed in e-format.
• Flags: The system displays up to 2 result flags if the calibration results were
flagged.
Acceptance Limits (Table) Displays information about the upper and lower cutoff configured for this
(RLUs) (Cutoff assay, including:
only) • Level: The calibrator level.
• Replicate Low: The lowest acceptable RLU for a replicate test.
• Replicate High: The highest acceptable RLU for a replicate test.
• Mean Low: The lowest acceptable RLU for the mean of the calibrator level
replicates.
• Mean High: The highest acceptable RLU for the mean of the calibrator level
replicates.
Curve (Log) or (Chart) Displays the curve generated from the calculated RLU means for this
Curve (Linear) calibration. You can use the left and right arrow keys (under the chart) to scroll and
(Curve only) view all of the data points.
• Point cursor: A blue, vertical line that highlights the point you have selected.
• RLUs (y-axis): The y-axis displays the range of mean RLU readings for
calibrator tested.
• Concentration (x-axis): The x-axis displays the range of calculated analyte
concentration means for each calibrator tested. The x-axis may be plotted on a
logarithmic (log) or linear scale.
• Points: The RLU and concentration means of each calibration test and its
replicates are plotted as points, which make up the calibration curve.
Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions (continued)
Previous Active F2 (Curve only) – Displays the previous active calibration for the
assay.
Last Run F3 – Displays the last run calibration.
For information about stored calibrations, see the Stored Calibration Data topic in
this chapter.
NOTE
Select Curve F1 is available only if other calibrations exist.
Switch Active (Button) Select to switch the active calibration for the assay with the previous
Curve F2 active calibration. The previous active calibration becomes the active calibration
and vice versa.
The system displays a confirmation message before the switch occurs.
Comment F3 (Button) Select to display the Calibration Comment window for the displayed
calibration. You can enter, view, or edit a comment for the calibration. Comments
print on the Calibration Data Report.
Print F7 (Button) Select to print the Calibration Data Report for the displayed calibration.
Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions (continued)
Calibration When a calibration fails, the system displays a failure code in the Status field on the
Failure Codes Calibration Data screens. The failure codes below are for either cutoffs or curves.
Bad Fit The curve does not meet the limits defined by the assay
protocol file (APF). This may be caused by poor precision or
a curve that was too flat or too steep.
CV Std 0 The %CV of the replicates for the S0 (zero) calibrator does
not meet the limits defined by the APF.
Insuff Data The system did not have enough data to perform calibration
calculations. This happens if two or more replicates are not
calculated, due to a short sample or an instrument error.
Limits The RLUs of either the individual replicates or the mean of
the replicates were outside the ranges specified in the APF.
Max Iterate The system was unable to create a curve before performing
the maximum number of calculation iterations. The system
attempts to calculate the curve 100 times before generating
this error.
No Fit The system was unable to fit a curve to the data points.
Possible causes include math rule violations, such as division
by zero or calculating the log of a negative.
Resp Delta The total response of the curve, which is the difference
between the highest RLU reading and the lowest RLU
reading, is too small.
Temp. Out The instrument case temperature changed more than 6°C
while the system processed the test replicates.
Viewing Cali- Use this procedure to view the calibration curve or cutoff, along with detailed
bration calibration data.
Curves and 1. Go to the Calibration screen. To get to this screen from the Main Menu, select
Cutoffs Calibration F5.
2. Select the button for the assay calibration and reagent lot you want to view.
(Optional) To view the previous active calibration curve, select Select Curve F1,
then Previous Active F2.
For more information about active, previous active, and last run calibrations, see the
Stored Calibration Data topic in this chapter.
Switching the Use this procedure to switch the active calibration with the previous active
Active with calibration. This procedure is for quantitative assays only.
the Previous NOTES
Active Cali-
• You cannot switch active and previous active calibrations while the system is
bration in the Running or Paused mode.
• This procedure will not alter curve expiration dates or recalculate results for
patient samples that have already been run.
• If there is no previous active calibration, the Switch Active Curve F2 button
is unavailable.
1. Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
2. Select the button for the assay calibration you want to switch.
5. Select OK F1.
The active and previous active calibration curves are switched. The previous active
calibration curve is displayed.
Adding a Cali- Use this procedure to enter, edit, or view a calibration comment.
bration Com-
1. Go to the Calibration screen. To get to this screen from the Main Menu, select
ment Calibration F5.
6. Select OK F1.
The comment is applied to the calibration and is printed on the Calibration Data
Report.
You can print calibration data in a report format. If a comment is entered for a
calibration, the comment displays on the report. Printed calibration data reports
include:
• Laboratory header information
• Date and time of printing
• Page number
• Line for the technologist signature
Printing a Cal- Use this procedure to print the Calibration Report or a Calibration Data Report.
ibration
1. Go to the Calibration Screen. To get to this screen from the Main Menu, select
Report Calibration F5.
3. Select OK F1.
The system prints the report (see Figure 6-12, Figure 6-13, and Figure 6-14 for report
examples).
Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 502338 Jane Smith
Filter: All Calibrations - Ascending Sorted by Test Name and Reagent Lot
Page 1 of 1
Technologist_________________________________________ Printed 04/04/07 12:43 PM
0790D.bmp
Figure 6-12 Calibration Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Data Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 414141 Jane Smith
Replicate Mean
Page 1 of 1
Technologist __________________________________________ Printed 09/23/11 03:19 PM
0907C.bmp
Figure 6-13 Calibration Data Report (Cutoff)
Laboratories, Inc.
Laboratory A
Calibration Data Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 500135 101-555-2323 ext. 109 Jane Smith
Page 1 of 1
Technologist ______________________________________________ Printed 2-02-01 11:05 AM
0791C.bmp
Figure 6-14 Calibration Data Report (Curve)
You calibrate an assay on an instrument before you run tests for that assay on the
instrument. However, before you calibrate, the solution used for calibrating the
individual assay must be set up on the Access 2 system.
Most calibrators are multi-level. They contain more than one solution, with each
solution containing a different level of analyte. When you add a multi-level calibrator
to the system, you add all levels of the calibrator as one calibrator. When you select a
multi-level calibrator to be used for a calibration, all levels of the calibrator are
included in the selection.
When you set up a calibrator, you associate it with a calibrator lot. Calibrator lots that
are set up on the system can be used to run calibrations on any instrument in your
workgroup. In contrast, a calibration curve or cutoff is only valid on the instrument on
which it was run.
For more information about running calibrations, see Chapter 3: Sample Management
in this manual.
You access the Calibrator Setup screen from the Main Menu.
0771B.bmp
Figure 6-15 Calibrator Setup Screen
Calibrator List (Fields) Displays all of the calibrators set up for all instruments in your system
workgroup. The following information about each calibrator is displayed:
• Test – Displays the test name.
• Calibrator Lot – Displays the calibrator lot number.
• Expiration – Displays the calibrator lot expiration date.
Add Calibrator (Button) Select to setup a calibrator by entering information in the Add Calibrator
F1 window.
Edit Calibrator F2 (Button) Select to edit an existing calibrator by editing the information in the Edit
Calibrator window.
Delete (Button) Select to delete a calibrator from all instruments in the workgroup.
Calibrator F6
Adding a Cali-
brator
Main Menu
Calibration
F5
Calibration
Calibrator Setup
F5
Calibrator Setup
Add Calibrator
F1
Add Calibrator
Calibrator
information No
correct?
Yes
OK
F1
0528A.wmf
Figure 6-17 Adding a Calibrator
1. Go to the Calibrator Setup screen. To get to this screen from the Main Menu,
select Calibration F5 to display the Calibration screen, then select
Calibrator Setup F5.
0765B.bmp
Figure 6-18 Add Calibrator Window
Bar Code (Field) Using the external bar code reader or keyboard,
enter the bar code ID printed on the calibrator card for the
calibrator to be added to the system.
Calibrator Name (Field) Displays the name of the calibrator.
Lot Number (Field) Displays the lot number for the calibrator.
Expiration Date (Field) Displays the expiration date of the calibrator.
Test (Column) Displays the test name of the calibrator.
Level (Column) Displays the level of the calibrator.
Stated (Column) Displays the stated concentration of each
Concentration calibrator level.
NOTE: This column is only for quantitative assays.
Units (Column) Displays the units of measure for each calibrator
level.
NOTE: This column is only for quantitative assays.
3. Use the external bar code reader to scan the bar code IDs listed on the calibrator
card.
NOTES
• For some multi-level calibrators (usually quantitative assays), you must enter
the bar code for each level in the Bar Code field. The system then displays
the level information in the table.
• For other multi-level calibrators (usually qualitative assays), the system
populates the calibrator levels, stated concentrations, and units automatically
in the table.
• If you enter an expired calibrator, the system displays a warning message.
• If you cannot scan the bar code ID on the calibrator card, you can type the
characters printed underneath the bar code in the Bar Code field.
Editing a Cali- Use this procedure to edit the bar code ID of an existing calibrator.
brator
1. Go to the Calibrator Setup screen. To get to this screen from the Main Menu,
select Calibration F5 to display the Calibration screen, then select
Calibrator Setup F5.
4. Use the external bar code reader to enter the bar code ID.
NOTES
• If you cannot scan the bar code ID on the calibrator card, you can type the
characters printed underneath the bar code in the Bar Code field.
• You cannot change the Calibrator Name, Lot Number, or Expiration Date.
• You cannot edit qualitative assays. The Bar Code field is unavailable for
these assays.
2. Go to the Calibrator Setup screen. To get to this screen from the Main Menu,
select Calibration F5 to display the Calibration screen, then select
Calibrator Setup F5.
NOTES
• Deleting a calibrator will also delete all calibration curves associated with the
calibrator lot.
• Within a workgroup, deleting a calibrator will delete it from all instruments
in the workgroup.
The system displays a confirmation window.
5. Select Yes F1 to delete the calibrator from all instruments in the workgroup.
7 Quality Controls
7.1 Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Quality controls are samples of known reactivity. You can run quality control samples
along with patient samples to monitor system performance.
The system performs quality control (QC) calculations by comparing the results to the
acceptable range of expected values you entered during QC Setup. QC calculations
include:
• The mean (average) test result value
• Standard deviation (SD) from the mean
• Percent coefficient of variation (%CV)
NOTE
These statistics are calculated on pooled data from all runs on a particular
instrument of that QC level.
The system stores the QC data in the database. You can view, print, copy, or delete
QC data. QC data can be viewed in a graphical format called a Levey-Jennings chart.
If the system is configured to apply Westgard rules to quality control test results, the
system alerts you when a quality control test result violates an applied Westgard rule.
When the system flags a result, the Quality Control status button turns red.
You can also enter comments for a specific patient result or quality control, and omit
points from the calculations. For example, you may want to enter a comment for a
known technical error. You may also want to enter a comment about why you are
excluding the result. The system displays omitted results on the screen and in reports,
but does not include them in calculations.
NOTE
Quality control samples should be run after any scheduled or unscheduled
preventive maintenance or repair to verify calibration.
For information about how to enter quality control test requests, see
Chapter 3: Sample Management.
For information about reviewing test results and result flags, see Chapter 5: Test
Results.
For information about Westgard QC rules, see Section 7.2: Reviewing Quality
Control Charts and Data.
For help on how to interpret failed quality controls, see Appendix A: Troubleshooting
in the Reference Manual.
Review QC
0750B-version1.1.wmf
Figure 7-1 Quality Controls Flowchart
You access the Quality Control screen from the Main Menu or from any screen by
selecting the Quality Control button.
0713B.bmp
Figure 7-2 Quality Control Screen
QC Buttons (Buttons) Quality control and comparison buttons. If there are more than 28
buttons, use the vertical scroll bar to display additional buttons.
NOTE
The system only displays quality controls that have been set up and run on the
instrument.
Applying a QC A quality control filter is a set of parameters you can change to reduce or expand the
Filter number of quality controls displayed on the Quality Control screen.
The screen is always filtered. The default filter is All Controls - sorted by Test Name,
then by Control Name.
NOTE
If you change the system ID for an instrument in your workgroup, the instruments
selected in the applied filter may also change. Test and update the filter to make
sure it operates as expected.
Use this procedure to select a filter for the quality control data.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
0758A.bmp
Figure 7-4 Filter (Quality Controls) Window
3. Select a filter from the list. The default sort orders for all filters are:
• 1st sort order: Test Name
• 2nd sort order: Control Name
(Optional) To use a different sort order, select the sort order you want to apply.
4. Select OK F1.
The system displays all quality controls that meet the selected parameters on the
Quality Control screen.
Deleting QC Use this procedure to delete a saved comparison. The comparison button is removed
Comparisons from the Quality Control screen.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
4. Select OK F1.
The system stores all quality control test results and QC calculations for each quality
control. You can review QC data, apply a filter to the quality controls displayed, and
compare Levey-Jennings charts for two or more quality controls.
QC data includes:
• Quality control name and lot number
• Date range (for all results)
• Number of results used in QC calculations (excluding omitted results)
• All test results (including all reagent pack lots used)
• Information set up in the system for the quality control
Each test result includes the measured response in RLUs, standard deviation intervals
(SDI), date and time of completion, applied QC rules, flags, and comments. Setup
information includes the quality control expiration date, expected mean, and expected
SD from the mean.
Westgard QC Westgard QC rules are interpretive rules developed to avoid excessive false rejection
Rules rates, to improve quality monitoring, and to decrease subjectivity of data analysis.
Each laboratory determines the QC rules to apply and the course of action to take
when a result violates a rule. Understand how your laboratory uses QC rules before
you set up controls.
Application of a QC rule consists of screening quality control test results for the
number of standard deviations (SD) above or below the mean, and for the number of
consecutive occurrences. Data points are colored red to mark violations of rules. For
each combination of control lot and reagent, you can apply one or more of these QC
rules:
• 12s (1-2s) - The system marks a data point if it is more than 2 SD from the
mean.
• 22s (2-2s) - The system marks a data point if two consecutive points of a
given quality control are more than 2 SD from the mean in the same
direction. The system only marks the second point.
• 13s (1-3s) - The system marks a data point if it is more than 3 SD from the
mean.
• 41s (4-1s) - The system marks a data point if four consecutive points of a
given quality control are more than 1 SD from the mean in the same
direction. The system only marks the fourth point.
• 10x (10x) - The system marks a data point if ten consecutive points of a given
quality control are on the same side of the mean (for example, ten points are
above the mean). The system only marks the tenth point.
You can view a Levey-Jennings chart to determine if quality control test results, over
a period of time, are within range or out of range. QC results that are within an
acceptable range form a normal distribution pattern with equal numbers of points
above and below the mean. A normal distribution has approximately:
• 70% of the points between +1 SD and -1 SD
• 25% between +1 SD and +2 SD or between -1 SD and -2 SD
• 5% between +2 SD and +3 SD or between -2 SD and -3 SD
You can detect out of range QC data by looking for the flagged result. The Access 2
instrument flags results that are out of range, based on the values you input during the
quality controls setup.
You access the QC Chart and Data screen from the Quality Control screen.
0751C.bmp
Figure 7-6 QC Chart and Data Screen
Pipettor (Field) Displays the value N/A. This field is reserved for future use.
Reagent Lot (Field) Displays the test reagent pack lot number used for the QC run. The
default value is All.
Start (Field) Displays the beginning date of the QC results in the chart. Unless you edit
the date range, the beginning date is the first day QC test results were obtained.
End (Field) Displays the ending date of the QC results in the chart. Unless you edit
the date range, the ending date is the day the most recent QC results were
obtained.
Mean (Field) Displays the calculated mean of the points within the date range. The
value displays with the number of decimal places defined for the assay, plus one
additional decimal place, up to a maximum of four decimal places. Omitted
points are not included in the calculations.
For information about defining the decimal places for an assay, see Section 4.4:
Test Setup in the Reference Manual.
SD (Field) Displays the calculated standard deviation (SD) for the points within the
date range. The value displays with the number of decimal places defined for the
assay, plus one additional decimal place, up to a maximum of four decimal
places. Omitted points are not included in the calculations.
For information about defining the decimal places for an assay, see Section 4.4:
Test Setup in the Reference Manual.
%CV (Field) Displays the calculated coefficient of variation (%CV) of the points
within the date range. The value displays with two decimal places. Omitted
points are not included in the calculations.
Points (Field) Displays the number of points within the date range used to calculate the
mean, SD, and %CV. Omitted points are displayed on the chart with a diagonal
line through them, but are not included in the calculations.
Levey-Jennings (Chart) Displays a graph of the plotted points from each control. Points for up to
Chart 31 days can be viewed at once. You can scroll left to right and back, to view all
of the data points, using the arrow buttons beneath the chart. Also see the Levey-
Jennings Charts topic in this section.
• Point cursor
The blue vertical line on the graph. You can move the line by using the left and
right arrow keys (found by each corner of the chart). This line marks the point
you have selected.
• Calibration Line
The dotted vertical line on the graph. This line marks a changed calibration curve
between the point the line runs through and the previous point.
• Y-axis Left Scale
Displays the 7 y-axis coordinates. These are the stated values for the mean and 1,
2, and 3 SDs above and below the mean.
• Y-axis Right Scale
Displays the 7 y-axis coordinates. These mark the mean and 1, 2, and 3 SDs
above and below the mean.
• X-axis
Displays the dates for the chart.
• Points
Represent the numerical value of the result. A diagonal line through the point
indicates an omitted point. Points greater than 3 SD above the mean are indicated
as solid triangles on the +3 SD line, and points greater than 3 SD below the mean
are indicated as solid triangles on the -3 SD line. Points that violate QC rules are
colored red.
Data Grid (Table) Displays a list of QC results and information specific to each data point
within the current date range, and contains the following columns:
• Value
Displays the result and the unit of measure.
• SDI
Displays the number of SD intervals the result is above or below the expected
mean.
• Completion
Displays the date and time of the completed result.
• QC Rules
Displays the QC rules applied to the test in bold black type and displays the
violated rules in red type with an asterisk on both sides.
• Comment
Select to read or enter a comment for a quality control sample. The default value
is no comment (pen). After you enter a comment and select OK, the pen symbol
turns into a notepad.
• Omit
Select to omit the result from QC calculations (point remains on chart).
• Pipettor
Displays the value N/A. This field is reserved for future use.
When you select a row in the data grid, the corresponding point is displayed on
the Levey-Jennings chart.
Filter F1 (Button) Select to limit displayed data to certain reagent lots and date ranges. For
more information, see the Applying a QC Chart and Data Filter topic.
Delete Point F5 (Button) Select to delete the currently selected point and all of that point data
from the system. You must have a password to use this feature. For more
information regarding passwords, see Chapter 4: System Configuration in the
Reference Manual.
Copy to Disk F6 (Button) Select to copy QC data to a disk or USB flash drive. For more
information, see the Copying QC Data to Disk or USB Flash Drive procedure.
Print F7 (Button) Select to print the QC chart and data for the currently selected quality
control.
Viewing Qual- Use this procedure to view the quality control data for a selected test. If you want to
ity Control view or compare more than one test, see the Comparing QC Charts procedure.
Charts and 1. Go to the Quality Control screen. To get to this screen from the Main Menu,
Data select Quality Control F4.
NOTE
Quality control tests may be completed while you are reviewing this screen. To
refresh the information displayed, exit the screen and redisplay it.
(Optional) To display data for a certain date range, or for a certain reagent pack
lot number, apply a filter. For more information, see the Applying a QC Chart and
Data Filter procedure.
(Optional) To add, edit, or view a comment for a selected result, select the
Comment button (pen or notepad) next to the appropriate result.
(Optional) To omit data from the QC calculations, select the Omit box next to the
appropriate result.
Applying a QC A QC chart and data filter controls the amount of data displayed on the QC Chart and
Chart and Data screen and printed in reports. The filter limits data according to the following
Data Filter parameters:
• By date range - You can display data for the last week, the last month, or
you can specify a starting and ending date.
• By reagent lot - You can display data from a single reagent lot or all reagent
lots.
Use the following procedure to apply a filter to the QC Chart and Data screen.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
2. Select the quality control for which you intend to view data.
1026A.bmp
Figure 7-8 Filter (QC Chart and Data) Window
NOTE
When viewing charts for date ranges greater than 31 days, the last date displayed
on the chart will be the date of the most recent point in the date range.
6. Select a single reagent lot to view, or select All to view data for all lots of the
reagent for the selected test.
7. Select OK F1.
The system applies the filter and displays the results on the QC Chart and Data screen.
Entering Use this procedure to enter, edit, or delete comments for quality control samples on
Quality Con- the QC Chart and Data screen.
trol Com- 1. Go to the Quality Control screen. To get to this screen from the Main Menu,
ments select Quality Control F4.
4. Select the Pen or Notepad button next to the appropriate result to display the QC
Comment window.
5. In the Comment field, enter or edit comments. Or, to delete an existing comment,
select it and press [Backspace].
Omitting a QC Use this procedure to omit a point from the mean, SD, and %CV calculations (QC
Data Point calculations). The point remains on the chart, marked as omitted by a diagonal line
through it.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
2. Select the quality control that contains the point you want to omit.
(Optional) To restore an omitted data point to the QC calculations, clear the Omit
box.
NOTE
If a data point is omitted by the system due to a fatal flag or other error condition,
the omission is permanent and the Omit box cannot be cleared.
Deleting a QC Use this procedure to delete a selected point from the screen, reports, and statistical
Data Point calculations. You must have the correct system password to use this option. An
information event is created in the Event Log.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
2. Select the quality control that contains the point you want to delete.
3. Select Review Chart and Data F2 to display the QC Chart and Data screen.
4. Select the point to delete. Touch the point or use the arrow keys in the bottom
corner of the chart to select the point.
Copying QC Use this procedure to copy QC data to a 3.5-inch high density, DOS-formatted disk or
Data to Disk USB flash drive.
or USB Flash The Access 2 system copies the QC data into a comma-separated field format that you
Drive can import to a PC-based spreadsheet program. The QC data fields are:
• Control lot headers
• Control lot data
• Data point headers
• Rows of data point values
NOTE
Copying QC data does not remove it from the database.
2. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
NOTE
Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the Access 2
instrument.
• To copy data to a USB flash drive, insert a flash drive into a port on the front
of the PC. If the front of the PC does not contain a USB port, use a port on the
back of the PC.
NOTE
For instruments set up to perform system backups using a USB flash drive, the
backup drive might already be in one of the USB ports on the back of the PC. Use
a different flash drive to copy data. Do not disturb the flash drive used for
backups when inserting and removing the flash drive for copying data.
5. Select Review Chart and Data F2 to display the QC Chart and Data screen, then
select Copy to Disk F6.
The Copy to Disk window is displayed.
6. Enter a name and file extension for the data file in the File Name field.
NOTES
• If you do not enter a file name or extension, the system supplies a default file
name based on the date and time and a .csv (comma delimited) extension.
• If the file name already exists, the system displays a message. To overwrite
the existing file, select Yes F1. To rename the new file, select Cancel F8.
(Optional) If your instrument has USB flash drive technology, confirm that the
correct drive is selected from the Drive list, or select a different drive.
NOTE
Unless directed by Technical Support, do not copy data to the C: Console PC
drive or any drive labeled BACKUPDRIVE.
(Optional) If the 3.5-inch disk is not formatted, select the Format Disk option.
7. Select OK F1.
A progress window is displayed.
• To stop the copy process at any time, select Cancel F8.
8. When the copy process is complete, the system displays a message. Remove the
disk or flash drive from the PC and label it.
You access the Compare Charts screen from the Quality Control screen.
0752C.bmp
Figure 7-10 Compare Charts Screen
Chart name (Field) Displays the test name, quality control name, quality control lot number,
and instrument number for data on the screen.
Date range (Field) Displays the start and end dates for the chart and data.
Mean (Field) Displays the calculated mean of the points within the date range. The value
displays with the number of decimal places defined for the assay, plus one
additional decimal place, up to a maximum of four decimal places. Omitted points
are not included in the calculations.
For information about defining the decimal places for an assay, see Section 4.4:
Test Setup in the Reference Manual.
SD (Field) Displays the calculated standard deviation of the points within the date
range. The value displays with the number of decimal places defined for the assay,
plus one additional decimal place, up to a maximum of four decimal places.
Omitted points are not included in the calculations.
For information about defining the decimal places for an assay, see Section 4.4:
Test Setup in the Reference Manual.
%CV (Field) Displays the calculated coefficient of variation of the points within the date
range. The value displays with two decimal places. Omitted points are not included
in the calculations.
Points (Field) Displays the number of points within the date range used to calculate the
mean, SD, and %CV. Omitted points are displayed on the chart with a diagonal
line through them, but are not included in the calculations.
Levey-Jennings (Chart) Displays two or three graphs of the plotted points from each quality
Charts control. You can scroll left to right and back, to view all of the data points, using
the horizontal scroll bar.
• Point cursor
The blue vertical line on the graph. You can move the line by using the left and
right arrow keys (found by each corner of the chart). This line marks the point you
have selected.
• Y-axis Left Scale
Displays the 7 y-axis coordinates. These are the stated values for the mean and the
1st, 2nd, and 3rd SDs above and below the mean.
• Y-axis Right Scale
Displays the 7 y-axis coordinates. These mark the mean and the 1st, 2nd, and 3rd
SDs above and below the mean.
• X-axis
Displays the dates for the chart.
• Points
Represent the numerical value of the result. A diagonal line through the point
indicates an omitted point. Points greater than 3 SD above the mean are indicated
as solid triangles on the +3 SD line, and points greater than 3 SD below the mean
are indicated as solid triangles on the -3 SD line. Points that violate QC rules are
colored red.
Arrow Buttons Select to move the point cursor on the chart left or right to the next data point, and
to select the corresponding row of the data table. The chart and table scroll as
necessary to display the new selection.
Save Comparison (Button) Select to save the comparison. If you save the comparison, the system
F1 creates a comparison button. You can then select the comparison button from the
Quality Control screen to view it.
Review Chart and (Button) Select to display the QC Chart and Data screen for one of the charts. A
Data F2 menu of chart numbers is displayed. Charts are numbered sequentially from the
top.
Edit Date Range F4 (Button) Select to change a date range of QC points to view.
Comparing
QC Charts Main Menu
Quality Control
F4
Quality Control
Compare Charts
F3
Is correct date
range displayed? No
Yes
Save the
No
comparison?
Yes
Save Comparison
F1
Save Comparison
0779C.wmf
Figure 7-12 Comparing QC Charts
Use this procedure to view QC charts and data for two or three quality controls at the
same time.
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
To remove a quality control from your selection, select the quality control button
again.
Saving QC Use this procedure to save the comparison from the Compare Charts screen.
Comparisons
1. Select Save Comparison F1 to save the selected quality controls as a comparison
button on the Quality Control screen.
The Save Comparison window is displayed.
2. Enter text for the comparison button (notes or information about the comparison)
in the Line 1 and Line 2 fields.
3. Select OK F1 to save the comparison and create a button on the Quality Control
screen.
NOTE
You can delete a saved comparison from the Quality Control screen using Delete
Comparison F4.
You can print QC data and charts or a list of quality controls in a report format. For
QC data and charts, the system prints the displayed data. To print what is not
displayed, use the date range option.
QC Review Report This report contains all of the quality controls in the
current filter and includes the quality control lot, test
name, reagent lot, expiration, and instrument. The report
is available only from the Quality Control screen.
QC Data Report This report contains the data for a specific quality control
and date range. The report is available only from the QC
Chart and Data screen.
QC Chart Report This report contains a Levey-Jennings chart for a specific
quality control and date range. If the applied filter
exceeds 31 days, the data continues on additional pages.
The report is available only from the QC Chart and Data
screen.
Printing a QC Use this procedure to print a QC Review Report (see Figure 7-13).
Review
1. Go to the Quality Control screen. To get to this screen from the Main Menu,
Report select Quality Control F4.
Laboratories, Inc.
Laboratory A
123 Lake Street
QC Review Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith
Page 1 of 1
Technologist ____________________________________________ Printed 10/10/02 02:43 PM
0772C.bmp
Figure 7-13 QC Review Report
Printing a QC Use this procedure to print a QC Chart Report, a QC Data Report, or a combination of
Chart or Data both reports.
Report 1. Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4
0759A.bmp
Figure 7-14 Print (QC Chart and Data) Window
Report Type (Boxes) Select either chart, data table, or both to print. For
an example of each report format, see Figure 7-16 and see
Figure 7-17.
Print Entire Date (Box) Select to print the entire date range selected in the
Range QC Chart and Data screen. If the date range is more than 31
days, charts continue on additional pages.
Clear to print only the data on the screen. Chart reports are
limited to 31 days, and data reports print only four lines.
(Optional) To print a wider range of data than you can view on the screen for a
QC Data or QC Chart report, select Print Entire Date Range.
6. Select OK F1.
The system sends the report to the printer.
0773Ea.bmp
Figure 7-16 QC Data Report
0774Ea.bmp.
Figure 7-17 QC Chart Report
You can set up quality controls to make them available to run on your
Access 2 system and to define quality control (QC) rules the system checks test
results against. A quality control lot can be configured for up to 50 assays. You must
set up each new lot of a quality control before you can select it during test request
entry. You must complete the following fields:
• Control
• Lot number
• Expiration date
• Sample type
• Test name
• Mean
• SD
• Units
• Westgard QC rules
You must establish the acceptable range of expected values (mean and standard
deviation) for quality controls specific to your Access 2 instrument. For each new lot,
use the manufacturer’s suggested ranges from the reagent instructions for use as a
guideline for the expected mean and standard deviation (SD), until you have
processed enough quality control samples to determine a mean and SD specific to the
instrument you use.
Main Menu
Quality Control
F4
Quality Control
QC Setup
F5
QC Setup
Add Control
F1
Add Control
OK
F1
All control
parameters No
entered?
Yes
Done
0780A.wmf
Figure 7-18 Setting Up Quality Controls
You access the QC Setup screen from the Quality Control screen.
0753C.bmp
Figure 7-19 QC Setup Screen
QC Setup List (List) Displays information for all quality controls defined in the workgroup.
The four columns of information are:
• Control
Displays the name of the quality control.
• Control lot
Displays the number of the quality control lot.
• Expiration
Displays the quality control lot expiration date.
• Sample
Displays the sample type.
Add Control F1 (Button) Select to add a quality control to the QC Setup list and enter the tests,
means, SDs, units, and QC rules to define it.
Edit Control F2 (Button) Select to edit an existing quality control.
Delete Control F6 (Button) Select to permanently remove a quality control from the system.
Adding a Use this procedure to define a new quality control and enter the tests, means, SDs, and
Quality Con- QC rules for that quality control.
trol 1. Go to the QC Setup screen. To get to this screen from the Main Menu, select
Quality Control F4 to display the Quality Control screen, then select
QC Setup F5.
0762C.bmp
Figure 7-21 Add Control Window
Control (Field) Enter a unique name for the new quality control.
Lot Number (Field) Enter a unique lot number for the new quality
control.
Expiration (Field) Enter the expiration date for the new quality control
lot number.
Sample Type (List) Select a sample type from the list.
Test Name (List) Select a test name from the list of tests enabled on
any instrument in the workgroup.
Mean (Field) Enter the expected mean for the test.
SD (Field) Enter the expected SD for the test.
Units (Field) Displays the test units.
Westgard QC (Boxes) Select the rules to apply for the new control.
Rules Your laboratory determines the Westgard QC rules to
apply and the course of action you need to take when a
result violates a rule. Understand how your laboratory uses
QC rules before you add controls. For more information,
see the Westgard QC Rules topic in Section 7.2: Reviewing
Quality Control Charts and Data.
Designated (Column) Displays the value N/A. This column is reserved
Pipettors for future use.
Clear Row F3 (Button) Select to clear the information from a selected
row.
Designate (Button) This button is reserved for future use.
Pipettor F4
3. Enter the quality control information and select the appropriate options to define
the new quality control.
NOTES
• Some multi-level quality controls have the same lot number for each level.
You can add the level (such as 1, 2, or 3) to the lot number to make it unique.
• The expiration date format follows the format you set up on the System Setup
screen. The system displays a message if the incorrect format is used. For
more information about setting the date format, see Chapter 4: System
Configuration in the Reference Manual.
• For a qualitative test, the standard deviation must be greater than 1. If you
enter an expected SD that is less than 1, the QC chart may not display the
data correctly.
(Optional) To delete the information in a row and start over with a blank row,
select Clear Row F3.
4. Select OK F1.
The system saves the new quality control and adds it to the QC Setup list.
NOTE
A warning message is displayed if you have missing or incomplete information.
(Optional) To delete the new quality control without saving it, select Cancel F8
and return to the QC Setup screen.
5. Record the quality control information on the QC worksheet (see Figure 7-23).
Do this for any quality control you set up.
4. To edit the expected mean for a quality control test, enter the new value in the
Mean field.
5. To edit the expected standard deviation for a quality control test, enter the new
value in the SD field.
6. To change the selected QC rules, select or clear the Westgard QC Rules boxes.
For more information, see the Westgard QC Rules topic in
Section 7.2: Reviewing Quality Control Charts and Data.
7. Select OK F1.
The system saves the quality control and updates the QC Setup screen.
NOTE
A warning message is displayed if you have missing or incomplete information.
2. Go to the QC Setup screen. To get to this screen from the Main Menu, select
Quality Control F4 to display the Quality Control screen, then select
QC Setup F5.
3. Select the quality control you want to delete from the QC Setup list.
6. Select OK F1.
The system removes the quality control from the QC Setup screen and any buttons
associated with it from the Quality Control screen.
This section provides a recommendation to establish quality control ranges for the
Access 2 Immunoassay System. This is only a recommendation and is not intended to
replace your existing laboratory procedure(s). Use this procedure, along with your
standard laboratory practices and manufacturer’s recommendations, for your quality
controls.
You can use the Quality Control worksheet (see Figure 7-23) to record the quality
controls you set up and all of the data associated with them.
NOTES
• Use fresh quality control materials for best results.
• Do not re-use quality controls by pooling into sample cups or storage
containers.
• For more information about requesting QC tests, see Section 3.4: Quality
Control Test Requests in this manual.
Collecting Use this procedure, along with your standard laboratory procedure, to establish
Data to Estab- quality control ranges.
lish QC Required Materials
Ranges
• Access 2 system assay calibrators (2 lots, if available)
• Access 2 system reagent packs (2 lots, if available)
• Tri-level quality controls (prepare the quality controls according to the
manufacturer’s instructions)
Steps
1. Run 1 or 2 replicates of each quality control one time each day. Vary the
sequence in which the quality control samples are processed.
4. Calculate the mean, %CV, 1SD, 2SD, and 3SD values, and the 3SD range for
each quality control level/analyte combination.
6. Perform a second outlier evaluation. Remove any values outside of the 3SD
range, then recalculate the mean, %CV, 1SD, 2SD, and 3SD values.
7. Calculate the acceptable 1SD, 2SD, and 3SD quality control ranges.
NOTE
If the %CV< 6, you may consider widening the ranges by multiplying the stated
SD by 1.5, then recalculating the 1SD, 2SD, and 3SD ranges.
8. Periodically recalculate the values and ranges during the life of the control lot.
Assigning Use this procedure to assign temporary or provisional quality control ranges.
Temporary
1. Run 1 or 2 replicates of each quality control daily.
QC Ranges
2. Record the values, using the following guidelines:
• If 1 replicate is run, record only 1 value per quality control level.
• If 2 replicates are run, record both individual values.
• Do not exceed 2 recorded values a day.
5. Verify that the calculated mean is within the manufacturer assigned range
provided in the quality control reagent instructions for use (if more than 1 range is
listed, use the 2SD range).
• If the mean is within the assigned range, calculate a temporary range for each
quality control level.
• If the mean is not within the assigned range, contact Technical Support.
• If no manufacturer assigned ranges are listed in the reagent instructions for use,
contact Technical Support.
After you set up the quality controls for the Access 2 instrument, you can record the
setup information on the Quality Control Worksheet. You can use the worksheet on
the following page as an original and make photocopies for use on each Access 2
instrument. Keep the worksheet, along with the any others, in one place that can be
referenced in the future.
0784a.bmp
Figure 7-23 Quality Control Worksheet
8 Routine Maintenance
8.1 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
For optimal performance, the Access 2 system requires routine maintenance. Routine
maintenance includes: Daily Maintenance, Weekly Maintenance, and the Utility
Assay.
Daily maintenance includes inspection, cleaning, and priming procedures that you
perform once every 24 hours. Weekly maintenance includes more cleaning
procedures and the System Check routine. You perform the System Check routine as
part of weekly maintenance to verify system performance. You can also run the
System Check routine to troubleshoot the system.
The Utility Assay runs automatically every four hours when the system is not
processing samples, and after the instrument finishes running the samples in the last
onboard rack. You can also run the Utility Assay manually, when requested by
Technical Support.
You can use the Maintenance Log as a checklist for performing all routine
maintenance procedures. Keep the Maintenance Log in this chapter as an original and
make photocopies for use with each Access 2 system in your laboratory. Retain the
completed Maintenance Logs for reference.
You access the Maintenance Review screen from the Main Menu.
0775C.bmp
Figure 8-1 Maintenance Review Screen
Zone (Fields) Displays temperatures in ºC for the incubator, wash carousel, substrate,
Temperature refrigerator, and instrument case. The temperatures are updated in real-time.
(deg C)
Limits (Fields) Displays the expected incubator, wash carousel, substrate, and refrigerator
temperature ranges in degrees Celsius.
System (Button) Select to display the System Checks screen.
Checks F2 For more information about System Checks, see Section 8.4: System Check.
Run Utility (Button) Select to run the Utility Assay.
Assay F5 For instructions on running the Utility Assay manually, see the Running the Utility
Assay procedure in this section.
Disable/Enable (Button) Select to disable and enable the automatic Utility Assay.
Utility Assay F6
For instructions on disabling the Utility Assay, see the Enabling/ Disabling the Utility
Assay procedure in this section.
Print F7 (Button) Select to print the Temperature Report, which shows the temperatures, duty
cycle, and status from the Analog Devices window (see Section 5.6: Analog and
Digital Device Diagnostics in the Reference Manual).
Running the The Utility Assay cleans the interior of the aspirate and dispense probes.
Utility Assay
If the The Utility Assay is enabled, it runs automatically at these times:
• After the instrument finishes running the samples in the last onboard rack.
• Every four hours, when the instrument is not processing samples.
NOTE
If you will not be using the instrument to process samples for an extended period,
be sure that the system has enough RVs to continue to run the Utility Assay. The
Utility Assay runs every four hours, and uses three RVs each time it runs. To
calculate the number of RVs needed, use the following formula:
For example:
50 (hours)
= 12 * 3 = 36
4 (hours)
Be sure 36 RVs are loaded on the instrument.
0922A.wmf
You can run the Utility Assay manually, when requested by Technical Support or
required for troubleshooting.
2. Go to the Maintenance Review screen. To get to this screen from the Main Menu,
select Maintenance Review F6.
NOTES
• In the Event Log, the system records that the run has started.
• You can perform other tasks while the Utility Assay is running, including
loading racks and most supplies.
WARNING
Disable the Utility Assay while you are working on the instrument for extended
periods of time to prevent injury from the instrument accidentally starting up.
1. Go to the Maintenance Review screen. To get to this screen from the Main Menu,
select Maintenance Review F6.
To restart the timer for the Utility Assay, select Enable Utility Assay F6.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The rack must have a rack ID between 1-57 or 400-456.
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
NOTES
• If you select Daily Clean System or Special Clean and a System Check, the
system runs the Daily Clean System or Special Clean routine before the
System Check.
• When you run the System Check or Special Clean routine, the system records
it in the Event Log.
0667A.bmp
Figure 8-3 Request Maintenance Window
Daily Clean (Option) Select to run the Daily Clean System maintenance
System routine.
Special Clean (Option) Select to run the Special Clean maintenance
routine.
No Clean (Option) Select to clear the Daily Clean System and the
Special Clean options.
System Check (Box) Select to run the System Check maintenance routine.
(List) Select a System Check maintenance routine from the
list.
5. Select OK F1.
The system displays the requested routine, sample types, completion time, and status
on the Maintenance Requests screen (see Figure 8-5).
6. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field on the Sample Manager screen.)
The system displays the Load Rack window and the instrument moves the sample
carousel into position for loading.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load it again after requesting the maintenance routine.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical
Support for assistance.
9. Select Run.
The completion time is updated on the Maintenance Requests screen.
10. When the maintenance routine is complete, unload the rack and select Done F1.
You access the Maintenance Requests screen from the Sample Manager screen.
NOTE
To get to the Maintenance Requests screen by entering a new rack, see the
Requesting Maintenance Routines procedure.
0668B.bmp
Figure 8-5 Maintenance Requests Screen
Rack Icon (Indicator) Displays the rack ID and position of each sample cup in the rack.
Rack ID If the sample cup is missing or the amount of sample is insufficient for completing a
test, the system turns the affected sample cup red.
Rack Location (Field) Displays the location of the rack.
Values are: Scanned/Loaded or Unloaded.
Rack Status (Indicator) Displays the sample processing status for the rack as determined by the
least processed sample in the rack.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, and
*Done*.
For more information about rack statuses, see Section 4.4: Monitoring Sample
Progress in this manual.
Position (Icon) Displays the samples in rows numbered 1-10 that correspond to the ten
positions in the selected rack, from left to right with the convex side of the rack facing
you. The fields in each sample position row pertain to the sample in that position in
the rack.
Routine (Field) Displays the name(s) of the maintenance routine(s) being run.
Values are: Daily Clean System, Special Clean, and System Check.
If you select individual system checks, System Check appears in the Routine field.
Sample Type (Field) Displays the contents and quantity of each sample cup needed in the rack,
according to the requested maintenance routines.
Completion (Field) Displays the estimated time the system will finish processing the tests
requested for the sample. For Special Clean and Daily Clean System, the completion
time is for the entire rack. For System Check, the completion time is shown for each
part of the routine.
Status (Field) Displays the sample status, as determined by the least processed test requested
for the sample.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done,
*Done*, and QNS (sample quantity not sufficient).
If the system cancels a test, it records the test name and sample ID on the Event Log
screen and the Event Log button turns red.
Load/Get (Button) Rack X is the rack selected on the Sample Manager screen. Select Load
Rack X F1 Rack X to load a rack if it is not onboard. If the rack is onboard, select Get Rack X to
present the rack at the sample carousel door, where you can add, remove, or rearrange
samples, or you can unload the rack.
Edit Request F2 (Button) Select to display the Request Maintenance window and change the selected
maintenance routines.
For instructions on requesting maintenance, see the Requesting Maintenance
Routines procedure in this section.
Maintenance (Button) Select to display the Maintenance Review screen (see Figure 8-1).
Review F6
In order to keep the Access 2 system running properly, perform daily maintenance
once every 24 hours. Daily maintenance is made up of the following procedures,
performed in sequence:
NOTES
• If you use the Access 2 system to process the Vitamin B12 assay, you should
also run the Special Clean routine at the end of every day or whenever you
will not use the instrument to process samples for 8 hours or more.
• Even if you do not use the system every day to run assays, it is still important
to perform daily maintenance on schedule to ensure that the system is ready
when needed.
Prime Fluidics
Main Menu
0787D.wmf
Figure 8-7 Daily Maintenance Flowchart
Materials You need the following materials to perform daily maintenance. This is the complete
Required for list of materials for all of the procedures. For a list of part numbers and for ordering
Daily Mainte- information, see the Instructions for Use.
nance WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Citranox cleaning solution is acidic and may cause eye or skin irritation. See
the manufacturer’s label for details.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
• Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
NOTE
Use only the 2.0-mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
Checking the
System Sta- Main Menu
tus
Maintenance Review
F6
Maintenance Review
Contact
Temperatures No Technical Support
in range?
Yes*
Supplies
Supplies
Correct Supply For information on adding supplies
and waste No Condition and changing waste containers,
containers
see Chapter 2: Supplies.
OK?
Yes*
Main Menu
Configure
F8
PC Admin
F7
PC Admin
Yes*
0592C.wmf
Figure 8-8 Daily Maintenance: Checking the System Status
Checking system status during daily maintenance includes the following items:
• Check zone temperatures
• Check system supplies
• Empty liquid waste bottle
• System backup
Use this procedure to check the system status during daily maintenance.
1. Go to the Maintenance Review screen. To get to this screen from the Main Menu,
select Maintenance Review F6.
NOTE
Frequent emptying of the waste bottle may extend its service life.
NOTE
Depending on your laboratory’s schedule, the system backup may or may not run
daily.
Inspecting the
Fluidic Mod-
ule
Open front panel
Is there
Contact
buildup or Yes Technical Support
corrosion?
No
Initial
Maintenance Log
0593Cwmf
Figure 8-9 Daily Maintenance: Inspecting the Fluidic Module
Use this procedure to visually inspect the fluidic module as part of daily maintenance
(see Figure 8-1).
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
2. Open the front panel of the instrument by grasping the lower portion of each side
of the front panel, gently pulling the bottom of the panel toward you, then lifting
the front panel upward.
3. Inspect all accessible tubing connections and valve and pump fittings for
crystalline buildup or corrosion.
If you find crystalline buildup or corrosion, contact Technical Support for assistance.
Deposits indicate that a connection or fitting may be leaking.
4. Close the front panel of the instrument by gently pulling the panel toward you and
lowering the panel to a closed position.
5. Initial the appropriate section of the Maintenance Log (see
Section 8.6: Maintenance Log).
Cleaning the
Wash Carou-
sel Probe
Clean substrate
Exteriors probe exterior with
deionized water
Clean dispense
probe exteriors with
deionized water
Clean aspirate
probe exteriors with
deionized water
Initial
Maintenance Log
0594A.wmf
Figure 8-10 Daily Maintenance: Cleaning the Wash Carousel Probe
Exteriors
Use this procedure to clean the exterior of the substrate, dispense, and aspirate probes.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
CAUTIONS
• Be sure not to bend or damage the fragile probe tips.
• To avoid contamination, use a new swab on each type of probe.
• Do not wipe the tip of the probe. Fibers on or inside the probes can clog
the probes or valves in the fluidic module.
2. Open the front panel of the instrument by grasping the lower portion of each side
of the front panel, gently pulling the bottom of the panel toward you, then lifting
the front panel upward.
3. Locate the substrate, dispense, and aspirate probes (see Figure 8-1).
7
6
1
5 4 3 2
1
6
3 2
5
4
0195H.eps
4. Gently wipe the exterior of the substrate probe with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
5. Gently wipe the exterior of the dispense probes with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
6. Gently wipe the exterior of the aspirate probes with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
NOTE
You do not need to clean the exterior of the aspirate probes if you are performing
weekly maintenance, and you have already installed clean aspirate probes.
7. Close the front panel of the instrument by gently pulling the panel toward you and
lowering the panel to a closed position.
8. Initial the appropriate section of the Maintenance Log (see
Section 8.6: Maintenance Log).
Priming the
Substrate
Main Menu
Diagnostics
F7
Prime Fluidics
F2
Prime Fluidics
Select Substrate
Start Priming
F2
Cancel
F8
Initial
Maintenance Log
0595A.wmf
Figure 8-12 Daily Maintenance: Priming the Substrate
Use this procedure to prime the substrate fluidic lines as part of daily maintenance.
2. Go to the Prime Fluidics window. To get to this window from the Main Menu,
select Diagnostics F7 to display the Diagnostics menu, then select Prime
Fluidics F2.
(Optional) To change the number of times the system primes the substrate, select
the Cycles field.
NOTE
When the substrate is priming, Start Priming F2 changes to Stop Priming F2.
Running the
Daily Clean
System Rou- Main Menu Maintenance Requests
tine
Sample Manager
Load Rack
F1
F1
Sample Manager
Load rack
Enter the Maintenance Rack
Number in the Rack ID field
Maintenance Request
F4 Run
Request Maintenance
The system cleans
probe interiors
Select Daily Clean (15 minutes)
System
OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, and 3
Unload rack
Pipette 2.0 mL
Contrad 70 into cup 1
Initial the
Maintenance Log
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Complete the remaining
Daily Maintenance
Pipette 2.0 mL routines
deionized water
or wash buffer
into cup 3
0596B.wmf
Figure 8-13 Daily Maintenance: Running the Daily Clean System Routine
The Daily Clean System routine cleans the interior of the primary, dispense, and
aspirate probes and primes the wash buffer lines. In addition to running this routine
during daily maintenance, also run this routine if you know that the instrument will
not be used to process samples for an extended period. Once you prepare and load the
rack, the Daily Clean System routine takes about 15 minutes to run.
Use this procedure to run the Daily Clean System routine as part of daily
maintenance.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• When you are performing the weekly maintenance routines, the Daily Clean
System routine is run with the System Check routine.
• Load the rack after requesting the maintenance routine. If you load the rack
first, the system recognizes the rack as a patient sample rack, and will not
accept the maintenance request. If the rack is already onboard, unload the
rack, clear it, and load it again after requesting the maintenance routine.
• You can request and load maintenance routines while the system is
processing patient samples.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The rack must have a rack ID between 1 and 57 or 400 and 456.
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
5. Select OK F1.
The system displays the requested routine, sample types, completion time, and status
on the Maintenance Requests screen.
6. Place the 2.0-mL sample cups in sample positions 1, 2, and 3 of an empty rack.
7. Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.
8. Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (mix 1 part
Citranox cleaning solution and 4 parts deionized water) into the sample cup in
position 2.
9. Pipette 2.0 mL of wash buffer (or deionized water) into the sample cup in
position 3.
10. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field on the Sample Manager screen.)
If the system is processing samples, it enters the Paused mode.
The system displays the Load Rack window and presents a rack position.
11. Load the rack.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load it again after requesting the maintenance routine.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical
Support for assistance.
13. Select Run.
NOTE
The Daily Clean System routine runs after the system completes the onboard
patient samples.
14. When the Daily Clean System routine is complete, unload the rack and select
Done F1.
In order to keep the Access 2 system running properly, perform weekly maintenance
once every seven days. Weekly maintenance is made up of the following procedures,
performed in sequence:
NOTE
Even if you do not use the system every day to run assays, it is still important to
perform weekly maintenance on schedule to ensure that the system is ready when
needed.
Clean the
Instrument Exterior*
Discoloration
Inspect the Liquid
Cracking or Crazing
Waste Bottle for Wear*
Bulging
Run Daily
Maintenance*
Run System
Check*
0808C.wmf
Figure 8-14 Weekly Maintenance
Materials You need the following materials to perform weekly maintenance. This is the
Required for complete list of materials for all of the procedures. For a list of part numbers and for
Weekly Main- ordering information, see the Instructions for Use.
tenance
WARNINGS
• Methanol is extremely flammable. Do not use near heat or flame. Do not
ingest. Avoid contact with eyes, skin, and clothing. Use with adequate
ventilation.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
• Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
• Lint-free cloth
• Deionized or distilled water
• Maintenance Log (see Section 8.6: Maintenance Log)
• Spare liquid waste bottle (as needed)
• Spare waste filter bottle (as needed)
• Alcohol or alcohol swabs or wipes (methanol can be substituted for cleaning
the exterior of the aspirate probes)
• Proper hand, eye, and facial protection for handling biohazardous materials
• Clean aspirate probes (three)
• Contrad 70 cleaning solution
• Beakers (two)
• Aspirate Probe Cleaning Kit (3.0 mL syringe, disposable aspirate probe
brush, aspirate probe syringe fitting assembly consisting of a fitting and
tubing)
• Disposable aspirate probe brushes (as needed)
• Absorbent paper
• Wash buffer
Cleaning the Use this procedure to clean the exterior of the system.
Instrument
1. Moisten a clean, lint-free cloth with deionized water (or distilled water).
Exterior
2. Wipe the exterior of the instrument with the moistened cloth.
Inspecting the Use this procedure to inspect the liquid waste bottle for wear.
Liquid Waste
Over time, the waste bottle can degrade, become brittle, and potentially crack. Any
Bottle for defect that is not removed by routine cleaning is a sign of deterioration. If you detect
Wear any issues with the waste bottle, replace the waste bottle with a clean spare bottle and
discard the old bottle.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1. Inspect the color of the liquid waste bottle. Note if the color has changed from
opaque white (new bottles) to yellow, orange or pink (deteriorated bottles). If you
observe a change in color, replace the bottle with a new bottle.
2. Inspect the area of the bottle that is nearest the handle and along all seams of the
bottle for cracking or crazing (spider web cracking), which are signs of
deterioration. If you observe cracking or crazing, replace the bottle.
3. Inspect the waste bottle for bulges. If you detect any bulges, contact Technical
Support to discuss the inspection findings and any further action.
Inspecting the
Waste Filter
Inspect waste filter
Bottle for bottle for fluid
Fluid
Yes
Initial
Maintenance Log
0600A.wmf
Figure 8-15 Weekly Maintenance: Checking for Fluid in the Waste Filter
Bottle
Use this procedure to check the waste filter bottle for fluid.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1. Inspect the waste filter bottle for fluid collecting in the bottom.
If fluid is visible, replace the waste filter bottle (see the Replacing the Waste Filter
Bottle procedure in Section 7.4: Fluids Tray and Instrument Base Procedures of the
Reference Manual).
Inspecting the
Primary Probe
for Buildup Open front panel
Is the probe
undamaged?
No Replace primary probe
Yes
Inspect primary
probe for
crystalline buildup
Is there Initial
buildup?
No Maintenance Log
Yes
0599C.wmf
Figure 8-16 Weekly Maintenance: Inspecting the Primary Probe
A bent, damaged, or dirty primary probe can lead to level sensing errors. During
weekly maintenance, visually inspect the primary probe for damage before cleaning
the probe exterior.
Use this procedure to inspect the primary probe and clean the probe exterior.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
2. Open the front panel of the instrument by grasping the lower portion of each side
of the front panel, pulling the bottom of the panel toward you, then lifting
upward.
3. Inspect the primary probe. If the probe is bent or damaged, replace the primary
probe. For more information about replacing the probe, see Section 7.6: Main
Pipettor Procedures in the Reference Manual.
4. Inspect the upper portion of the primary probe for crystalline buildup (see
Figure 8-17). If you see crystalline buildup, carefully wipe the upper portion of
the primary probe with an alcohol swab or a lint-free cloth dampened with
alcohol.
CAUTION
Do not wipe the tip of the probe. Fibers on or inside the probes can clog the
probes or valves in the fluidic module.
0161B.eps
5. Close the front panel of the instrument by gently pulling the panel toward you and
lowering the panel.
Replacing the
Aspirate
Turn the
Probes instrument off
Install a clean
aspirate probe
Turn the
instrument on
Clean the
Soak the probes in
probes within No distilled water
one hour?
Yes
0776C.wmf
Figure 8-18 Weekly Maintenance: Replacing the Aspirate Probes
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• You must shut the instrument off while replacing the aspirate probes.
2. Locate the power switch on the lower right side of the instrument (near the back),
and turn off the power to the instrument by pressing the lower part of the switch
to off (O position).
2 3
1
6
1
5 4 3 2
6 4
5
0152Ic.eps
NOTE
There are seven probes on the wash arm: three wash buffer dispense probes, three
aspirate probes, and one substrate dispense probe. The probe positions are
numbered sequentially from RIGHT to LEFT. If you cannot identify the correct
probes, contact Technical Support.
5. Gently grasp the black retainer of the aspirate probe above the wash arm. Gently
push down on the retainer, then rotate it 1/4 turn counterclockwise.
CAUTION
Handle the aspirate probes with extreme care. The probes are fragile, and
will not function properly if bent.
6. While holding the probe by the black retainer, lift up, and remove the probe from
the wash arm. Be careful not to bend the probe.
7. Grasp the aspirate probe tubing at the barbed fitting, and pull the tubing until it
separates from the fitting. The tubing will stretch (see Figure 8-20).
2
4
3
0153dC.eps
If you do not plan to clean the removed probes within one hour, place them in
distilled water.
NOTE
You can either install the clean aspirate probes from a supply of probes in the
CARE kit, or clean the removed probes and reinstall them on the instrument.
Use this procedure to install the clean aspirate probes after removing the aspirate
probes from the instrument.
1. Push the aspirate probe tubing onto the barbed fitting of a clean aspirate probe,
being careful not to damage the barbed fitting or probe assembly.
Be sure that the tubing is pushed all the way to the barbed fitting collar. If the tubing is
not flush against the collar, the wash system may be adversely affected.
0799B.eps
2. Route the tubing under both the clear, rigid pipettor tubing and the wiring located
to the left of the pipettor gantry.
3. From the top of the wash arm, carefully route the clean probe down through the
opening in the wash arm. Rotate the black retainer until the two tabs engage the
slots in the wash arm.
4. While holding the probe by the black retainer, gently push down on the retainer
and then turn it 1/4 turn clockwise.
5. Lift gently on the probe tubing to be sure the probe moves up and down.
6. Repeat step 1 through step 5 to install the other two aspirate probes.
8. If you used any CARE kit parts, reorder the parts. For ordering information, see
the Instructions for Use.
9. Turn on the power to the instrument by pressing the upper part of the power
switch to on (| position).
Cleaning the Use this procedure to clean the aspirate probes. This procedure has three parts:
Aspirate • Precleaning the aspirate probes
Probes • Cleaning the aspirate probes with Contrad 70 cleaning solution.
• Cleaning the aspirate probes with distilled water.
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Once a disposable aspirate probe brush has been used to clean 1 to 3 aspirate
probes, it is considered a biohazard. Handle and dispose of the brush
according to appropriate laboratory safety procedures. Do not save a used
brush for future use.
• Methanol is extremely flammable. Do not use near heat or flame. Do not
ingest. Avoid contact with eyes, skin, and clothing. Use with adequate
ventilation.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
CAUTIONS
• Handle the aspirate probes with extreme care. The probes are fragile,
and will not function properly if bent.
• The disposable aspirate probe brush handle bends easily.
NOTE
Always keep a spare set of new or previously cleaned aspirate probes in the
CARE kit. During weekly maintenance, remove the aspirate probes and replace
them with the spare set from the CARE kit. Clean the removed probes and store
them in the CARE kit for the next time you perform the weekly maintenance
procedures. For information about ordering replacement probes, see the
Instructions for Use.
0818a.wmf
Figure 8-22 Weekly Maintenance: Precleaning the Aspirate Probes
2. Dip the aspirate probe brush in the undiluted Contrad 70 cleaning solution.
3. Carefully insert the brush into the bottom of the aspirate probe, and push the
brush in until the brush tip protrudes slightly from the other end of aspirate the
probe.
WARNING
Take the necessary precautions when removing and reinserting the probe brush
to avoid scattering droplets of biohazardous material into the air.
5. Repeat step 3 through step 5 several times on the same probe until no orange
residue is visible on the brush after removing it from the probe.
6. Repeat step 3 through step 6 for to preclean the other two aspirate probes.
0819a.wmf
Figure 8-23 Weekly Maintenance: Cleaning the Aspirate Probes with
Contrad 70 Cleaning Solution
0400E.eps
1 Syringe
2 Syringe Fitting
3. Push the barbed fitting of the aspirate probe into the open end of the tubing on the
syringe fitting.
4. Empty the syringe, forcing the Contrad 70 cleaning solution through the aspirate
probe and back into the beaker.
5. Flush the probe again by drawing the Contrad 70 cleaning solution into the
syringe through the aspirate probe and then emptying the syringe through the
probe into the beaker.
7. Repeat step 2 through step 6 for the other two aspirate probes.
Initial the
Maintenance Log
0778a.wmf
Figure 8-25 Weekly Maintenance: Cleaning the Aspirate Probes with
Distilled Water
4. Empty the syringe, forcing the water through the aspirate probe tubing and into a
sink.
5. Rinse the probe three more times by drawing water from the same beaker into the
syringe through the aspirate probe, and then emptying the syringe through the
probe into a sink.
7. Carefully wipe the exterior of the probe with alcohol or alcohol swabs or wipes
(methanol can be substituted).
8. Position the probe upright on absorbent paper for about 10 minutes to allow
residual fluid to drain.
9. Repeat step 1 through step 7 for the other two aspirate probes.
10. Store the clean set of probes in your CARE kit or install them on the instrument.
Running Daily As part of weekly maintenance, you should perform daily maintenance procedures.
Maintenance For information about how to do this, see Section 8.2: Daily Maintenance.
NOTE
Because installing clean aspirate probes is part of weekly maintenance, you do
not need to clean the exterior of the aspirate probes, as described in the daily
maintenance procedures.
Running Sys- As part of weekly maintenance, you should run the System Check routine. For
tem Check information about how to do this, see Section 8.4: System Check.
You perform the System Check routine as part of weekly maintenance to verify
system performance. During weekly maintenance, the three System Checks (washed,
unwashed, and substrate) are run together. You can also run the System Check routine
more often, or perform individual checks.
For information on running individual system checks, see Section 5.11: Individual
System Checks in the Reference Manual.
System The System Checks screen displays an overview of the results from the System Check
Checks routine. The System Check routine generates six values that are represented by data
Screen points on the corresponding charts on the screen.
You access the System Checks screen from the Maintenance Review screen.
Out-of-Limit Data (Icons) Red triangles identify results that are above or below the expected range. Red
Points diamonds identify results that are within the expected range, but the %CV is out of
range.
Date Run (Scrolling region or x-axis at the bottom of the screen) Displays the date that the
System Check routine was run. The system displays a maximum of 25 dates, displays
only the dates when a System Check was run, and repeats dates if more than one
System Check was run on the same date.
Point Cursor (Cursor) A blue vertical line indicates the System Check that is currently selected.
The point cursor can be moved left or right by selecting the left and right arrow
buttons, or by touching a data point.
Washed RLU (Chart) Displays the mean RLUs of the washed check within the range of expected
results, from 5,000 to 20,000 RLUs.
Substrate RLU (Chart) Displays the mean RLUs of the substrate check within the range of expected
results, from 5,000 to 9,000 RLUs.
Unwashed RLU (Chart) Displays the mean RLUs of the unwashed check within the range of expected
results (guideline only), from 4 to 10 million RLUs.
Wash Efficiency (Chart) Displays the results of the wash efficiency calculation within the range of
PPM expected results, from -1.0 to + 1.0 ppm (parts per million).
Substrate Ratio (Chart) Displays the results of the substrate ratio calculation within the range of
expected results, from 0 to 1.40.
Substrate : Wash (Chart) Displays the results of the substrate to washed ratio calculation within the
ed Ratio range of expected results (guideline only), from 0 to 1.25.
System Check (Button) Select to display the System Check Data screen for the selected System
Data F2 Check. You can use the screen to view the detail of the System Checks and to print
the System Check Report.
You access the System Check Data screen from the System Checks screen.
0783D.bmp
Figure 8-28 System Check Data Screen
Completion (Field) Displays the completion date and time of the System Check.
Wash Efficiency (Field) Displays the results of the wash efficiency calculation in parts per million.
Out-of-range results are displayed in red.
Substrate Ratio (Field) Displays the results of the substrate ratio calculation. Out-of-range results are
displayed in red.
Substrate : (Field) Displays the results of the substrate to washed ratio calculation. Out-of-range
Washed Ratio results (guideline only) are displayed in red.
Washed (Field) Displays the mean RLUs, SD, and %CV of the washed check. Out-of-range
results are displayed in red.
All three results (mean RLUs, SD, and %CV) display in red if the system encounters
a fatal flag while running a replicate.
Clean (Field) Displays the mean RLUs, SD, and %CV of the clean check. The results of the
clean check are used for troubleshooting purposes only.
Substrate (Field) Displays the mean RLUs, SD, and %CV of the substrate check. Out-of-range
results are displayed in red.
All three results (mean RLUs, SD, and %CV) display in red if the system encounters
a fatal flag while running a replicate.
Unwashed (Field) Displays the mean RLUs, SD, and %CV of the unwashed check. Out-of-range
results (guideline only) are displayed in red.
All three results (mean RLUs, SD, and %CV) display in red if the system encounters
a fatal flag while running a replicate.
Sample ID (Data Column) Displays the name of the System Check that was run on the sample
(either washed, unwashed, clean, or substrate).
RLU (Data Column) Displays the RLUs for the selected sample.
Dark Count (Data Column) Displays the dark count for the selected sample.
Drift Corr (Data Column) Displays the drift correction factor for the selected sample.
Pipettor (Data Column) Displays the value N/A. This column is reserved for future use.
Flags (Data Column) Displays up to two result flags for the selected sample.
Previous (Button) Select to display the data for the previous date that a System Check was
Check F2 performed.
Next Check F3 (Button) Select to display the data for the next date that a System Check was
performed.
Print F7 (Button) Select to print the System Check Report for the selected System Check.
Viewing and Use this procedure to view the detail for the System Check results, and to print the
Printing Sys- System Check Report for a selected System Check.
tem Check 1. Go to the Maintenance Review screen. To get to this screen from the Main Menu,
Result Data select Maintenance Review F6.
NOTE
If you do not select a specific System Check result, data for the most recent result
is displayed.
5. To view other System Check results for a date close to the displayed data, select
Previous Check F2 or Next Check F3.
Laboratories, Inc.
Laboratory A
System Check Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith
Page 1 of 1
Technologist______________________________ Printed 03/08/07 07:41AM
0807D.bmp
Figure 8-30 System Check Report
Running the
System Check Main Menu Maintenance Requests
Routine
Sample Manager
Load rack
Type Rack ID
Unload rack
OK
F1
Pipette 2.0 mL
undiluted System
Check Solution Results Repeat the
into cup 7 No
acceptable? System Check
Enter values
Results
and initial Yes
acceptable?
Maintenance Log, as
applicable
Leave cup 9 empty
No
Troubleshoot System
Pipette 1.0 mL Check results, or
1/501 System Check contact Technical
Solution into cup 10 Support
0601C.wmf
Figure 8-31 Running the System Check Routine
WARNING
System Check Solution and wash buffer contain a preservative which may cause
sensitization by skin contact. After contact with skin, wash immediately with
soap and water. Wear suitable gloves.
• 13-mm rack for 2-mL sample cups; the rack must have a rack ID between 1
and 57 or 400 and 456
• 2.0-mL sample cups (four cups)
NOTE
Use only the 2.0-mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• If a fatal flag is applied to a system check result, the system will not use the
results in the calculation of the mean, SD, or %CV. For more information,
see Section A.2: System Check Troubleshooting in the Reference Manual.
• You can request and load maintenance routines while the system is
processing patient samples. The maintenance routines run after the system
completes the onboard patient samples.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The new rack is displayed in the Off Board list on the Sample Manager screen.
3. Select Maintenance Request F4. The Request Maintenance window is displayed
over the Maintenance Requests screen
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
4. Select the System Check box and select All from the list.
NOTE
If you are running weekly maintenance, select the Daily Clean System option to
run the Daily Clean System and System Check routines at the same time. Follow
the procedure for Running the Daily Clean System Routine to load the sample
cups.
5. Select OK F1.
The Maintenance Requests screen is displayed.
8. Pipette 2.0 mL of undiluted System Check Solution into the sample cup in
position 7. The sample cup should be full, but the solution level should not be
higher than the top of the cup.
9. Pipette at least 1.0 mL of wash buffer into the sample cup in position 8.
11. Pipette 1.0 mL of the 1/501 diluted System Check Solution into the sample cup in
position 10.
12. Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
If the system is processing samples, it enters the Paused mode.
The system displays the Done window and presents a rack position.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load it again after requesting the maintenance routine.
For more information on how to load a rack, see Section 3.1: Sample Management in
this manual.
The routine, sample type, completion time, and status are displayed on the
Maintenance Requests screen.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical
Support for assistance.
The system displays the testing results as the samples are processed. When processing
is complete, the system runs the Utility Assay.
16. When the System Check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample Management.
17. Compare the obtained results with the expected results displayed on the screen.
• If the results are within the expected limits and you are running weekly
maintenance, record the results of the System Check routine in the appropriate
sections of the Maintenance Log (see Section 8.6: Maintenance Log).
• If the results are outside the expected limits, repeat the System Check routine. If
out-of-range results persist, troubleshoot or contact Technical Support.
System Check The following results from the System Check routine should display on the System
Expected Checks and System Check Data screens. For troubleshooting information, see
Results Appendix A: Troubleshooting in the Reference Manual.
The Special Clean routine prevents buildup of debris in the primary and aspirate
probes. You perform the Special Clean routine when additional cleaning is requested
by Technical Support or required for troubleshooting.
NOTES
• If you run the Vitamin B12 assay on your Access 2 system, perform the
Special Clean routine at the end of each day or whenever the instrument will
not process samples for 8 hours or more.
• Special Clean contains the Daily Clean System routine; therefore, you cannot
select these routines at the same time.
Running the
Special Clean Main Menu Maintenance Requests
Routine
Sample Manager
Load rack
Enter the Maintenance Rack
Number in the Rack ID field
Maintenance Request
F4 Run
Request Maintenance
The system cleans
probe interiors
(30 minutes)
Select Special Clean
OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, 3, 4, 5, and 6
Unload rack
Pipette 2.0 mL
Contrad 70 into cup 1
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Pipette 2.0 mL
deionized water or
wash buffer into cup 3
Pipette 2.0 mL
70% ethanol* into cups
4, 5, and 6 * Alternatively, a 70% methanol
solution may be used
0810C.wmf
Figure 8-33 Special Clean Routine
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
• Citranox cleaning solution is acidic and may cause eye or skin irritation. See
the manufacturer’s label for details.
• Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
• Ethanol and methanol are extremely flammable. Do not use near heat or
flame. Do not ingest. Avoid contact with eyes, skin, and clothing. Use with
adequate ventilation.
• 13-mm rack for 2-mL sample cups; the rack must have a rack ID between 1
and 57 or 400 and 456
• 2.0-mL sample cups (six cups)
NOTE
Use only the 2.0-mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
After you prepare and load the rack, the Special Clean routine takes approximately
35 minutes to complete.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
You can request and load maintenance routines while the system is processing
patient samples. The maintenance routines run after the system completes the
onboard patient samples.
1. Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2. Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Request F4, the Sample Manager screen is no
longer displayed.
5. Select OK F1.
7. Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.
WARNING
Ethanol and methanol are extremely flammable. Do not fill sample tubes on the
instrument or in the rack position in the sample carousel. Remove sample tubes
from the instrument immediately after completing the Special Clean routine.
10. Pipette 2.0 mL of 70% ethanol* into each of the cups in sample positions 4, 5,
and 6.
Sample
1 2 3 4, 5, 6
Position
11. Select Load Rack X F1 on the Maintenance Requests screen. (The X represents
the number of the rack that you entered into the Rack ID field on the Sample
Manager screen.)
If the system is processing samples, it enters the Paused mode.
The system displays the Done window and presents a rack position.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack first,
the system recognizes the rack as a patient sample rack, and will not accept the
maintenance request. If the rack is already onboard, unload the rack, clear it, and
load it again after requesting the maintenance routine.
For more information on how to load a rack, see Section 3.1: Sample Management.
The Routine, Sample Type, Completion time, and Status are displayed on the
Maintenance Requests screen.
WARNINGS
• Unless there is an emergency, let the maintenance routine run to completion.
Cancelling the routine may damage the instrument and compromise the
integrity of subsequent test results.
• If you cancel the routine, do not initialize the system. Contact Technical
Support for assistance.
13. Select Run.
14. When the Special Clean is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample Management.
* Alternatively, a 70% methanol solution may be used—mix 7 parts methanol and 3 parts wash buffer
You can use the Maintenance Log to verify that you perform all routine maintenance
procedures. Make photocopies of the log for use with each Access 2 system.
A paper copy of the log is provided in the Instructions for Use. Retain completed
Maintenance Logs for reference.
DAILY MAINTENANCE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
8-62
Check Zone Temperatures
Check System Supplies
Empty Liquid Waste Bottle
System Backup Successful?
Inspect Fluidic Module
8.6: Maintenance Log
SYSTEM CHECK RESULTS Week 1 Week 2 Week 3 Week 4 Week 5 Expected Results
Today’s Date *The Substrate :
Washed RLU/%CV 5,000 to 20,000 / 12.00 Washed Ratio and the
Unwashed Check RLU
Substrate RLU/%CV 5,000 to 9,000 / 5.00
mean result are not
Unwashed RLU/%CV 4 to 10 million* / 2.00 system specifications.
Wash Efficiency PPM -1.0 to +1.0 They are only
Substrate Ratio 0 to 1.40 reference guidelines.
Substrate : Washed Ratio 0 to 1.25*
C85818-AA
Tech Initials
This page may be reproduced for laboratory use.
Access 2 Operator's Guide A: Racks and Sample Containers
A.1 Racks
You load sample containers onto the Access 2 instrument in racks. Each rack holds up
to 10 samples in the rack sample positions. The instrument holds up to six racks.
To accommodate sample containers of different sizes, the instrument uses three types
of racks:
• 13 mm (for 12 mm and 13 mm sample tubes)
• 16 mm elevated (for 16x75 mm sample tubes)
• 16 mm (for 16x100 mm sample tubes)
Racks are identified by a bar code label. You affix the label to the rack according to
the type of rack and the type of sample container you plan to use in the rack. Rack bar
code labels 100 to 1899 include an icon to identify the type of sample container in the
rack. Bar code labels 1 to 99 do not include an icon because you can use them for
several different types of sample containers.
When the instrument scans the rack bar code label, it identifies the type of sample
containers in the rack and determines the appropriate pipetting depth for aspirating
sample. You must be sure that the sample volume is sufficient for pipetting. For
example, a 12x75 mm tube has a corresponding dead volume of 500 µL and is placed
in a rack with an ID between 1300 and 1399. Table A-1 summarizes which rack and
rack ID you must use for the various sample containers.
CAUTION
Only load sample containers on a rack with the appropriate ID.
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs, see Table A-5 in Section A.2: Sample
Containers.
Table A-1 Sample Containers with Corresponding Rack and Rack IDs
Attaching To be sure that the internal bar code reader can accurately read the rack bar code label,
Rack Bar use this procedure to place the label on a rack.
Code Labels 1. Locate the rack spine. The spine is located directly below the handle of the rack
and divides the 10 sample positions into two sets of 5.
2
3
05
05
05 1
0126C.eps
R
1 0-1 mm
2 Handle
3 Spine
2. Locate the indentation on the spine that indicates the correct location for the bar
code label.
3. With the bar code nearest the handle of the rack and the corresponding number
underneath it (see Figure A-2), align the bar code label with the indentation and
attach the label securely to the rack. To be sure the rack bar code is scanned
correctly, there should be only a 0-1 mm gap at the bottom of the label.
Cleaning Clean racks in a dishwasher or autoclave, or use a brush and a mild detergent.
Racks
NOTES
• The 2.0 mL/13 mm sample cups in racks 1-99 or 400-499 must be used for
maintenance. You do not affix bar code labels to maintenance sample cups.
The system recognizes the sample cups by the rack ID, by the way you
request tests in the system, and by the way you load the racks onto the
instrument (see the Requesting Maintenance Routines procedure in
Section 8.1: Routine Maintenance).
• You can intermix the allowable types of sample containers that are used in
racks 1-99 for patient samples and quality controls. For calibrators, each
sample in a calibrator set must be in the same type of sample container.
You place most sample containers directly in the rack. If you use insert cups,
however, place them into sample tubes or rack inserts before adding them to the rack.
WARNINGS
• Use only the recommended sample containers on the Access 2 instrument.
The system software contains specific parameters for each of the
recommended sample containers. Other containers can damage the system
and compromise the integrity of the test results.
• Remove caps from all sample containers before loading on the
Access 2 system.
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs, see Table A-5 in this section.
Calculating To be sure the sample volume is sufficient for the tests to be run, calculate the total
Sufficient volume of sample needed for the sample container by using this equation:
Sample Vol-
ume Sample volume
Number of Total sample
required per x replicates + Dead volume = volume required
replicate
0616A.wmf
NOTES
• To find the sample volume required per replicate, see the reagent instructions
for use.
• Dead volume is the amount of sample in the bottom of a sample container
that is required to be sure that enough sample is available for the instrument
to complete an assay.
WARNING
If you use tubes with separator gel, be sure that the tube contains sufficient
sample volume. Insufficient sample volume may cause the instrument to attempt
to aspirate the separator gel, which can damage the instrument and compromise
the integrity of the test results.
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs, see Table A-5 in this section.
Attaching To be sure the internal bar code reader can correctly read the sample bar code label,
Sample Bar use this procedure to place a label on a sample container.
Code Labels
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
The internal bar code reader automatically discriminates between symbologies,
so samples with bar code labels using different symbologies can be included on
the same rack. You may need to enable parameters for the bar code symbologies
you use (see Section 4.3: Bar Code Reader Setup in the Reference Manual).
1. Place the bar code label on the sample container so that the label is at least
0.25 inches from the top and bottom of the container (see Figure A-3). Be sure
that it is securely fastened.
2. When you add the sample container to the rack, be sure the sample bar code label
is centered in the opening slot of its rack position for accurate scanning.
1
ABC123456789
ABC123456789
2
0124D.eps
Using Insert An insert cup has a smaller sample volume requirement and a smaller dead volume
Cups in Bar than a sample tube. You may need to transfer sample from a sample tube to an insert
Coded Sam- cup to meet the total sample volume required for testing.
ple Contain- Use this procedure to add an insert cup to a bar-coded sample tube.
ers WARNING
Carefully pipette small sample volumes into the insert cup to prevent air bubbles
from forming at the meniscus. Air bubbles can affect level sensing by the
instrument and compromise the integrity of the test results.
1. Transfer the required sample volume from the sample tube with a bar code label
into the insert cup.
2. Place the cup back into the original sample tube, which has the bar code label
attached (see Figure A-4).
3. Add the tube to a rack appropriate for the insert cup and the sample tube. Be sure
the sample bar code is centered in the opening slot of its rack position for accurate
scanning.
2
ABC123456789
XXX
3
0127D.eps
1 Insert Cup
2 Sample Tube
3 Rack ID
Access 2 Sys- The following table lists all of the sample containers you can currently use on the
tem Sample Access 2 instrument, the corresponding rack ID range and the dead volume for each
Containers container.
WARNINGS
• You must have a sufficient volume of sample to process the tests you
requested. To be sure you have enough sample, calculate the total volume
needed for the sample container using the Calculating Sufficient Sample
Volume procedure in this section. If you do not follow the provided
procedure, sample processing problems may occur without warning.
• Remove caps from all sample containers before loading on the
Access 2 system.
13x100 GEL
13x75 GEL
13x100
13x75
16x100 GEL
Access 2.0 mL/13 mm Sample Cup Access 1.0 mL/13 mm Insert Cup
• Border: Dark green in 13x100 mm Tube
13x100
2.0 mL
400-499 have the icon) • Rack IDs: 600-699
• Dead Volume: 150 µL • Dead Volume: 400 µL
16 mm
• Rack IDs: 1600-1699 • Rack IDs: 200-299
• Dead Volume: 400 µL • Dead Volume: 400 µL
Sarstedt
Table A-5 Sample Containers with Rack and Volume Requirements (continued)
Sarstedt
• Border: Gray-brown
• Rack IDs: 2400-2499
• Dead Volume: 6 mL
9.0 mL
Table A-5 Sample Containers with Rack and Volume Requirements (continued)
Index
Rack, A-2
A Sample, A-7
Access 2 System Documentation, Preface-3 Bar Code Readers
Active Calibrations Scanning Containers in Racks, 3-8
Defined, 6-9 Wand Scanning Procedure, 2-6
Switching with Previous, 6-16 Working with On-Board Samples, 3-49
B
Back Tab, 1-20
C
Backups Calculations, Quality Control, 7-3
Daily Maintenance, 8-16 Deleting Data Points, 7-18
Omitting Data, 7-15
Bar Code Labels
Omitting Data Points, 7-18
Attaching rack, A-4
Attaching sample, A-7
Refrigeration Results, QC
Storing Reagent, 2-42 See QC Charts and Data
Regulatory Routine Maintenance, 8-1
Notice to User (EU), 1-5 Daily, 8-12
Symbols and Statements, 1-5 Effect on Warranty, 1-4
Reports Overview, 8-3
Calibration, 6-18, 6-20 Utility Assay, 8-5
Calibration Data (Curve), 6-22 Weekly, 8-26
Calibration Data (Cutoff), 6-21 Rules for Assigning Tests to Containers, 4-8,
Continuous Sample, 5-50 4-9
Laboratory Information, 1-24 Rules, Westgard QC
Patient, 5-47 See Westgard QC Rules
Printing a Calibration, 6-19 Run Button
Printing System Check, 8-49 Description, 1-15
Printing Test Results, 5-45 Sample Processing, 4-5
Printing the Reagent Inventory, 2-53 RV Cartridge, 2-25
QC Chart, 7-26
RV Load Door, 2-26
QC Data, 7-26
RV Waste Bag Button, 2-28
QC Review, 7-26
Quality Control, 7-26 RV Waste Bags
Reagent Inventory, 2-54 Button, 2-28
Result Report Types, 5-43 Changing the, 2-29
Sample, 5-48 Changing the (Flowchart), 2-29
Selected Test Results, 5-49 Overview, 2-28
Standard Information, 1-24 Supply Status, 2-3
Supplies Required, 4-17 RVs
System Check, 8-50 Button, 2-24
Test Results, 5-43 Changing the Waste Bag, 2-29
Work Pending, 4-23 Loading, 2-25
Requests Loading (Flowchart), 2-25
Entering Calibration Test, 3-39 Loading Capacity, 2-24
Entering Calibration Test (Flowchart), Supplies, 2-3
3-38 Supply Overview, 2-24
Entering Quality Control Test, 3-44 Supply Status, 2-3
Entering Quality Control Test (Flowchart),
3-43
S
Maintenance Routines, 8-7
Patient Test, 3-17
Safety
Features, 1-4
Processing LIS Patient Test, 3-25
General Information, 1-5
Processing LIS Test (Flowchart), 3-25
Interlock Switch, 1-4
Using Batch (Flowchart), 3-34
Laser Symbol, 1-5
Rerun Tests
Notice to User (EU), 1-5
Work Pending, 4-18
Symbols, 1-4
Work Pending Filter, 4-21
Warnings, Preface-14
Reservoir Receptacle, 2-13
Sample Bar Code Labels
Result Flags Attaching, A-7
See Test Result Flags
Volumes Website
Calculating Sufficient Sample, A-6 Technical Documents, Preface-3
Dead, A-9 Technical Support, Preface-14
Sample Required, A-2, A-6 Weekly Maintenance
Checking for Fluid in the Waste Filter
W Bottle (Flowchart), 8-30
Checking for Waste Fluid, 8-30
Warnings
Cleaning Aspirate Probes, 8-38
Citranox Handling, 8-14
Cleaning the Aspirate Probes with Contrad
Contrad Handling, 8-14 70 Cleaning Solution (Flowchart),
Indicators of Harm, Preface-14 8-40
Instrument, 1-5 Cleaning the Aspirate Probes with
Sodium Azide, 1-5 Distilled Water (Flowchart), 8-42
System Check Handling, 8-52 Cleaning the Instrument Exterior, 8-29
Wash Buffer Handling, 2-11 Cleaning the Primary Probe Exterior
(Flowchart), 8-31
Warranty
Daily Maintenance Portion, 8-43
Required Routine Maintenance, 1-4
Flowchart, 8-27
System, 1-4
Inspecting the Liquid Waste Bottle, 8-29
Wash Buffer
Overview, 8-26
Bottle, 2-11, 2-13
Precleaning the Aspirate Probes
Button, 2-11
(Flowchart), 8-39
Changing the Bottle, 2-12
Primary Probe Inspecting and Cleaning,
Changing the Bottle (Flowchart), 2-12 8-31
Contamination, 2-12 Replacing the Aspirate Probes, 8-33
Mixing, 2-12 Replacing the Aspirate Probes
Reservoir, 2-11, 2-13 (Flowchart), 8-33
Reservoir Overflow, 2-13 Required Materials, 8-28
Safe Handling, 2-11 System Check Portion, 8-43
Supplies, 2-3 System Checks, 8-44
Supply Status, 2-3 Westgard QC Rules
Wash Buffer Valve Assembly, 2-13 Description, 7-10
Wash Efficiency, Expected Results, 8-55 Editing for Quality Controls, 7-37
Washed Check, Expected Results, 8-55 Window Button Bar in Help, Preface-9
Waste Containers Window View Button, Preface-8
Liquid Waste Bottle, 2-14 Windows
RV Waste Bag, 2-28 Add Calibrator, 6-27
Supplies, 2-3 Add Control (QC), 7-35
Waste Filter Bottle Change Substrate, 2-20
Checking for Fluid, 8-30 Common, 1-23
Checking for Fluid (Flowchart), 8-30 Configure Screen (Test Results), 5-30
Waste Handling Copy to Disk (Test Results), 5-38
Changing the RV Bag, 2-29 Edit Filter (Test Results), 5-15
Liquid, 2-14, 2-15 Filter (Calibration), 6-6
Filter (QC Chart and Data), 7-16
Waste, Liquid
Filter (Quality Controls), 7-7
See Liquid Waste
Filter (Reagent Inventory), 2-50