BD FACSVia Instructions For Use

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BD FACSVia™ System

Instructions For Use

IVD

23-14662-01
1/2016

Becton, Dickinson and Company Becton Dickinson Pty Ltd,


BD Biosciences 4 Research Park Drive,
2350 Qume Drive Macquarie University Research Park,
San Jose, CA 95131 USA North Ryde NSW 2113, Australia

EC REP Benex Limited Becton Dickinson Limited,


Pottery Road, Dun Laoghaire, 8 Pacific Rise, Mt. Wellington,
Co. Dublin, Ireland Auckland, New Zealand
Tel +353.1.202.5222
Fax +353.1.202.5388

BD Biosciences
European Customer Support
Tel +32.2.400.98.95
Fax +32.2.401.70.94 bdbiosciences.com
help.biosciences@europe.bd.com ClinicalApplications@bd.com
Copyrights
© 2016, Becton, Dickinson and Company. All rights reserved. No part of this publication may be reproduced,
transmitted, transcribed, stored in retrieval systems, or translated into any language or computer language, in
any form or by any means: electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without
prior written permission from BD Biosciences.
The information in this guide is subject to change without notice. BD Biosciences reserves the right to change
its products and services at any time to incorporate the latest technological developments. Although this guide
has been prepared with every precaution to ensure accuracy, BD Biosciences assumes no liability for any errors
or omissions, nor for any damages resulting from the application or use of this information. BD Biosciences
welcomes customer input on corrections and suggestions for improvement.

Trademarks
Trademarks are the property of their respective owners.
© 2016 BD. BD, the BD Logo, and all other trademarks are property of Becton, Dickinson and Company.

Regulatory information
For In Vitro Diagnostic Use.

For US:

Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.

Class 1 Laser Product.

FCC information
WARNING: Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.

NOTICE: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct the
interference at his or her own expense. Shielded cables must be used with this unit to ensure compliance with
the Class A FCC limits. This Class A digital apparatus meets all requirements of the Canadian Interference-
Causing Equipment Regulations. Cet appareil numérique de la classe A respecte toutes les exigences du
Réglement sur le matériel brouilleur du Canada.

Electromagnetic Compliance
The BD FACSVia System complies with standard EN 61326-2-6:2013, Section 9.3 (emission and immunity
requirements). This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment
it may cause radio interference, in which case, you may need to take measures to mitigate the interference. The
electromagnetic environment should be evaluated prior to operating the device. Do not use this device in close
proximity to sources of strong electromagnetic radiation (eg, unshielded intentional radio frequency sources),
as these can interfere with the proper operation.
History

Revision Date Change made

23-14662-00 6/2015 New document

23-14662-01 1/2016 Updated clinical software to include new applications,


additional software preferences, and physician and
summary reports.
Contents

Chapter 1: Introduction 9
About this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Additional documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Chapter 2: About the system 15


BD FACSVia system overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
BD FACSVia cytometer overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
BD FACSVia Loader overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
BD FACSVia clinical software overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Software preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Chapter 3: Startup and shutdown 43


Startup workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Filling the fluid bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Emptying the waste bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Starting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Shutting down the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Chapter 4: Quality control 55


QC overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Running instrument QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Adjusting the bead regions and markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
vi BD FACSVia System Instructions for Use

Viewing QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Viewing Levey-Jennings plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Chapter 5: Data acquisition 75


Acquisition workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Acquire tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Setting up the worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Running samples manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Running samples using a Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Rerunning samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Reviewing reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Adjusting regions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Adjusting the threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Adjusting compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Chapter 6: Maintenance 103


Maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Cleaning the outside of the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Backflushing the SIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Performing a SIP clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Cleaning the fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Running an extended flow cell clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Cleaning the fluid bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Replacing the fluid bottle filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Replacing the in-line sheath filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Replacing the peristaltic pump tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Purging the fluid sensor lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Unclogging the SIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Aligning the Loader after a collision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Restarting the system after storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Contents vii

Chapter 7: Administrative tasks 127


Managing user accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Managing files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Selecting the report language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Configuring BD FACSLink™ software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Chapter 8: Troubleshooting 137


Troubleshooting overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Hardware troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Software troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Acquisition troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
QC troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
BD FACSLink software troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Chapter 9: Technical specifications 151


System specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Index 157
1
Introduction
This chapter covers the following topics:

• About this guide (page 10)


• Additional documentation (page 11)
• Safety symbols (page 12)
• Technical support (page 13)
10 BD FACSVia System Instructions for Use

About this guide


Introduction This topic describes the information that is available in this guide.

In this guide This guide provides information for setting up and running the
BD FACSVia™ system during a typical workflow, whether you are
acquiring samples manually or using a BD FACSVia™ Loader.

In addition to becoming familiar with the instructions outlined in


the guide, operators must receive the appropriate training on the
BD FACSVia system before attempting to operate the system.

This guide includes:

• An overview of the BD FACSVia system


• Introductory information about system hardware and
components
• Instructions on setting up and maintaining the system
• Instructions for performing daily quality control and sample
acquisition
• Troubleshooting information

Additional In the software, click Help in the menu bar to open the Help.
information
The Help system is a comprehensive collection of information that
includes all content from this instructions for use (IFU) in HTML,
as well as a PDF of the BD FACSVia™ System Safety and
Limitations Guide.

You can use the table of contents, interactive links, or the search
tool to locate topics of interest. Search results are displayed in a
familiar web search format to help you find information quickly.
Use the print tools to print individual topics or to print entire
sections as formatted PDF files.

Internet access is not required to access the Help system.


Chapter 1: Introduction 11

Additional documentation
Introduction This topic describes additional documentation available for the
BD FACSVia system.

Documents The following table lists the available documents for the
BD FACSVia system.

Document Description
Application guide An application guide for each test provides
information about the test and what it
measures. The application guide also
contains information on how to adjust
regions and describes the laboratory report.

BD FACSVia™ System Provides the site requirements. Read this


Site Preparation Guide guide before the system is installed.

BD FACSVia™ System Provides safety guidance and system


Safety and Limitations limitations. Read this guide before running
Guide the system. It can also be found in the Help.

Reagent kit Provides information about the reagent kit


instructions for use contents and instructions on staining
samples.

BD™ CS&T Beads Provides instructions on preparing the


instructions for use BD CS&T beads for quality control.

More information • About this guide (page 10)


• Safety symbols (page 12)
• Technical support (page 13)
12 BD FACSVia System Instructions for Use

Safety symbols
Introduction This topic describes the safety symbols used in this guide. For a
complete description of all safety hazards, see the BD
FACSVia System Safety and Limitations Guide.

Safety symbols The following table lists the safety symbols used in this guide to
alert you to potential hazards.

Symbol Meaning
Caution. Indicates the need for the user to consult the
instructions for use for important cautionary information
such as warnings and precautions that cannot, for a
variety of reasons, be presented on the medical device
itself.

Biological hazard

Electrical hazard

Laser hazard

More information • Additional documentation (page 11)


Chapter 1: Introduction 13

Technical support
Introduction This topic describes how to get technical assistance.

Contacting To contact customer support:


technical support If assistance is required, contact your local BD Biosciences
technical support representative or supplier. Visit our website,
bdbiosciences.com, for up-to-date contact information.

When contacting BD Biosciences, have the following information


available:

• Product name and serial number


• Any error messages
• Details of recent system performance

More information • About this guide (page 10)


This page intentionally left blank
2
About the system
This chapter covers the following topics:

• BD FACSVia system overview (page 16)


• BD FACSVia cytometer overview (page 18)
• BD FACSVia Loader overview (page 26)
• BD FACSVia clinical software overview (page 30)
• Software preferences (page 35)
16 BD FACSVia System Instructions for Use

BD FACSVia system overview


Introduction This topic describes the BD FACSVia system and components.

Intended use The BD FACSVia™ flow cytometer with BD FACSVia™ clinical


software identifies and enumerates leucocyte subsets for human
cells in suspension.

BD FACSVia system The BD FACSVia system includes the BD FACSVia flow cytometer,
a computer workstation running BD FACSVia clinical software for
acquisition and analysis, and the optional BD FACSVia Loader.
The system also includes BD™ CS&T instrument QC beads. An
optional barcode reader can be attached to a USB port on the
computer.

BD FACSVia The two-laser, six-parameter flow cytometer is composed of


cytometer fluidics, optics, and electronics systems.

• The fluidics system consists of peristaltic pumps providing a


non-pressurized, “push/pull” fluid system.
Chapter 2: About the system 17

• Clustered in a pie configuration around the flow cell, the


optical detectors maximize light collection.
• The electronics system provides up to 7 decades of dynamic
range, allowing for fixed detector voltages.

Workstation and The system comes with a dedicated USB-compatible PC with


software monitor, keyboard, and mouse. The computer runs BD FACSVia
clinical software, which is used to control the cytometer, acquire
samples, and generate results. Pre-defined assays are included with
the software.

Note: While BD FACSVia clinical software is running, the


computer will not enter sleep mode. Do not change the power
options or force the computer to go to sleep while the software is
running.

Reagents BD CS&T beads are used to check and monitor the cytometer
performance. Run instrument QC daily, ensuring that the test
passes before running samples.

The BD FACSVia system works with several existing reagents and


protocols. Use the pre-defined software module with the
corresponding reagent kit to run the assay you chose. For
instructions on preparing samples, see the specific reagent kit
instructions for use.

Loader option The BD FACSVia Loader is an optional accessory that saves you
time and effort by automating the sample loading step. Place a
24-tube rack of standard 12 x 75-mm tubes on the Loader and
select RUN. The Loader automatically agitates the tubes to keep
the cells in suspension, then loads each tube for acquisition. Use
the software to program sample injection probe (SIP) cleaning and
rinsing during the run.

More information • BD FACSVia cytometer overview (page 18)


• BD FACSVia clinical software overview (page 30)
18 BD FACSVia System Instructions for Use

BD FACSVia cytometer overview


Introduction This topic describes the cytometer and its major components.

Main components The BD FACSVia cytometer is composed of fluidics, optics, and


electronics subsystems that work together to analyze cells.

Outside of The following figures show the front and back of the cytometer
cytometer and locations of the indicator lights, power button, sample
injection probe (SIP), and connectors.

Front

1
5
2

3
Chapter 2: About the system 19

The following table describes the components on the front of the


cytometer.

No. Item Description


1 Event indicator Blinks as events pass in front of the laser. The
higher the event rate, the faster it blinks.

2 Power-on Illuminates solid blue to indicate that the


indicator cytometer is on and ready to use. Blinks
during startup and shutdown.

3 Power button Used to turn on and off the cytometer.

4 SIP Sample injection probe. Used to pull sample


from the sample tube to the flow cell.

5 Sample stage Used to hold the sample tube in place.


20 BD FACSVia System Instructions for Use

Back

The following table describes the components on the back of the


cytometer.

No. Item Description


1 Power connector Connects the AC power cord to the
instrument.

2 Loader connector Used only to connect the BD FACSVia


Loader.

3 USB port Used to connect the computer


workstation.

4 Fluidics harness Mesh outer tubing that contains fluid


lines connecting four fluid bottles to the
internal fluidics system.
Do not disconnect the harness from the
back of the instrument.
Chapter 2: About the system 21

Optical The following figure shows the optical components.


components
Do not remove the optical filters (shown below encompassing the
flow cell).

4
22 BD FACSVia System Instructions for Use

The following table describes the optical components.

No. Component Description


1 Blue laser 488 nm

2 Red laser 640 nm

3 Optical assembly (four  FL1 533/30 nm


filters are highlighted)  FL2 585/40 nm
 FL3 >670 nm
 FL4 675/25 nm

4 Flow cell (in center of Capillary where the laser intersects


four filters) the sample stream

Fluidics The BD FACSVia cytometer is a non-pressurized system. If


components necessary, any of the bottles can be opened while the cytometer is
powered on. However, we recommend waiting to fill the fluid
bottles until the instrument is idle.

During operation the software will notify you if the fluid level for a
fluid bottle is getting low or the waste bottle is getting full. Always
attend to the fluid bottles when instructed.

The following figure shows the fluidics components. The plastic


storage bin located inside the instrument is not shown.
Chapter 2: About the system 23

5 6

3
8
4

The following table describes the fluidics components.

No. Component Description


1 Sheath bottle 2-L bottle for 0.2-µm filtered deionized
(blue) (DI) water with Sheath Additive

2 Waste bottle (red) 2-L bottle to collect waste

3 Detergent solution 250-mL bottle for detergent solution


bottle (green)

4 BD FACSClean 250-mL bottle for BD™ FACSClean


bottle (yellow) solution
24 BD FACSVia System Instructions for Use

No. Component Description


5 In-line sheath filter In-line filter to filter the sheath fluid.
Additionally, three disk filters (located in
the fluid bottles) filter the fluid in each
bottle (sheath, BD FACSClean, and
Detergent solution).

6 Sheath pump Peristaltic pump that moves sheath fluid


from the sheath bottle through the system.

7 Waste pump Peristaltic pump that moves fluid to the


waste bottle.

8 SIP Sample injection probe. Pulls sample from


the sample tube to the flow cell. Shown in
figure in Outside of cytometer (page 18).

Loading a tube To manually load a tube:


1. Grasp the bottom of the sample stage between your thumb and
index finger and push it back.

2. Place the tube over the SIP.


Chapter 2: About the system 25

3. While holding the tube, pull the sample stage forward to


support the tube.

Adjusting the Note: This procedure applies to manual acquisition only. If you
height of the are using a Loader for acquisition, the sample stage was removed
sample stage to accommodate for the Loader.

The bottom of the sample stage contains a metal platform that can
be adjusted to two different positions. It can be raised or lowered
to accommodate both BD Trucount™ tubes and standard
12 x 75-mm tubes.

When loading BD Trucount tubes you can lower the platform to


prevent the SIP from hitting the retainer at the bottom of the tube.
You can also run 12 x 75-mm tubes in the lowered position. Or,
you can raise the sample stage platform when loading standard
12 x 75-mm tubes to allow the SIP to reach the bottom of the tube.

To adjust the height of the metal platform in the sample stage:


1. Push up on the underside of the metal platform in the sample
stage to raise the platform. Then, using your other hand,
swivel the platform 90° to raise/lower it.
26 BD FACSVia System Instructions for Use

Each 90° turn will raise or lower the platform.

BD FACSVia Loader overview


Introduction This topic describes the BD FACSVia Loader and how to use it to
automatically load samples.

About the Loader The BD FACSVia Loader is an optional sample loading accessory
that agitates and delivers tubes to the BD FACSVia cytometer for
sample acquisition. The Loader can be included as an option on a
new system, or it can be ordered and installed at a later time by a
BD field service engineer.

The Loader holds a custom rack of 24 standard 12 x 75-mm tubes


or BD Trucount tubes. Two racks are supplied with the Loader. Do
not use any racks other than the ones supplied for this Loader.

Three fixed tube locations at the back of the Loader tray allow you
to load tubes for cleaning, rinsing, and backflushing the SIP.
Chapter 2: About the system 27

Loading a rack Always use the Eject Rack/Load Rack buttons in the software to
move the Loader. Never move the Loader by hand.

Caution: Moving parts! Keep your hands away from the


Loader when it is moving. Never move the Loader by
hand.

To load a rack:
1. If necessary, click Eject Rack on the Acquire tab or Instrument
QC tab.

2. Place the 24-tube rack on the Loader.


28 BD FACSVia System Instructions for Use

The rack fits one way on the tray, ensuring that position A1 is
in the upper-left corner.

3. Press RUN A1 (or the designated tube location) on the Acquire


or Instrument QC tab to load the rack and begin acquisition.

Note: If you simply need to change the cleaning tubes, click


Eject Rack and replace the tubes, followed by Load Rack.

The Loader positions the selected tube under the SIP for
acquisition. A tube rack map on the screen allows you to see
the tube that is being acquired. The location flashes blue and is
outlined in red.

Cleaning tube The Loader is equipped with three fixed tube locations to support
locations the system cleaning functions. Check and replace these tubes after
system startup, after every worklist, and as needed.
Chapter 2: About the system 29

Each location is designated by a symbol. The following table


describes the details of each location.

Location Description
Triangle ( ) Place a tube containing 2 mL of BD FACSClean in
this location. Used for the first tube in a SIP Clean.

Circle ( ) Place a tube containing 2 mL of DI water in this


location. Used for the second tube in a SIP Clean.

Square ( ) Place a tube containing 2 mL of DI water in this


location. Used at startup and shutdown, during a
backflush, and for a SIP Rinse. Also used for
parking the SIP at shutdown.

Recommendations This list provides recommendations to follow when using a


when using the Loader:
Loader
• Keep fresh cleaning tubes in the three fixed locations during
operation. For optimal performance, change the tubes after
startup, after every worklist, and as needed. If left unattended,
the tube in the square location could overflow.
• Sample tubes should not contain more than 2.5 mL of sample
to avoid spillover during agitation. Cleaning tubes in the three
fixed locations should not contain more than 2 mL of liquid.
• Use the software to move the Loader. Do not try to move it
with your hands.
• Keep your hands and objects out of the path of the Loader.
• Ensure the SIP is parked in water at shutdown.

More information • Running samples using a Loader (page 87)


• Aligning the Loader after a collision (page 124)
30 BD FACSVia System Instructions for Use

BD FACSVia clinical software overview


Introduction This topic provides an overview of the BD FACSVia clinical
software main screen.

About BD FACSVia BD FACSVia clinical software allows you to control the


clinical software BD FACSVia cytometer to run QC, acquire samples, and view
results. When the optional Loader is installed, the software also
controls the Loader, allowing you to walk away as the instrument
agitates the tubes, acquires the samples, and performs a cleaning
cycle at the end of the worklist. The software provides the
following features:

• A quality control (QC) module that allows you to check and


monitor the instrument’s performance over time
• Tabs for entering worklist information and viewing data plots
• Data plots that are specific to the test you are running
• Reports to review, approve, and print results
• Various cleaning options to clean the SIP, flow cell, and fluidics
lines
• Ability to export files in FCS 3.1 format
• A Help system that includes all of the content from this IFU

Software The main software window is called the workspace. The


workspace workspace contains controls and displays that provide access to all
overview the functions for acquiring samples and viewing results. You can
enter all the necessary information about each sample, then save
the workspace file and open it later when you are ready to run the
samples. When the run is complete, the workspace is saved with
the results.

The workspace is organized in two tabs—Acquire and Review:

• Acquire tab. Allows you to acquire samples and view the


data. The Acquire tab contains the Worklist View tab and the
Plot View tab.
Chapter 2: About the system 31

– Worklist View tab allows you to enter information about


the samples and set up the worklist. When you begin
sample acquisition, either manually or using the Loader,
the screen switches to the Plot View to display the data as it
is acquired.
– Plot View tab allows you to view the data plots during
sample acquisition.
• Review tab. Allows you to view the results for any samples
that you ran, whether in the current worklist or a previously
saved worklist.

Workspace main components


The workspace consists of the following general components. For
detailed information on the various text fields and controls used
for sample acquisition, see Acquire tab (page 77).
32 BD FACSVia System Instructions for Use

The following table describes the general components on the main


workspace.

No. Component Description


1 Title bar Displays the workspace file name (or untitled if you have not yet
named it), and the standard window controls (minimize, maximize,
close).

2 Menu bar Displays the following menus and options.


File. Includes options for opening a new or existing workspace file
and for saving a workspace file. Also included are options to search
for samples, export data, set preferences, and exit the software.
Instrument. Includes options for cleaning the cytometer, aligning the
Loader, and setting the cytometer threshold and compensation. Also
includes an option to update the firmware. Use only when directed
by a BD representative.
Platform. Appears only when an administrator is logged in and the
application that supports dual-platform is installed. This feature
allows administrators to run some CD4 tests without BD Trucount
tubes. See the appropriate application guide for information on using
the dual-platform feature.

Admin. Appears only when an administrator is logged in. It includes


options for administrators to add and delete users, select the
language for reports, and configure BD FACSLink™ settings.
Help. Includes safety and product documentation and general
information about the system.
Chapter 2: About the system 33

No. Component Description


3 Traffic light Indicates the status of the instrument.
Green. Light is green when the cytometer is ready to acquire and
during sample acquisition.
Yellow. Light is yellow when the cytometer is performing an action,
such as backflushing, rinsing the SIP, and cleaning cycles; or if a non-
critical error, such as low sheath or full waste, occurred. Light is also
yellow at shutdown and for 15 minutes during startup, indicating the
cytometer is not ready.
Red. Light is red when a critical error has occurred or the Loader
arm has collided.

4 Real-time Displays the number of events, acquisition time, and event rate.
acquisition
counts

5 Backflush/ Provide easy access to backflushing and SIP cleaning functions


SIP Clean during a run. The checkbox that appears below these buttons allows
buttons you to automatically clean the SIP after the worklist is complete.

Software In addition to the standard workspace components, when a Loader


workspace for the is installed, the workspace also displays a tube rack map, a Load/
Loader Eject Rack button, and an option to rinse the SIP between samples.
34 BD FACSVia System Instructions for Use

The following table describes the features that appear in the


software only when a Loader is installed.

No. Item Description


1 Tube rack map Allows you to see the tube that is being
acquired. The current tube location flashes
blue and is outlined in red.

2 Load/Eject Rack Allows you to load and eject a rack.


button

3 Rinse SIP Provides the option to automatically rinse


checkbox the SIP between samples.
Chapter 2: About the system 35

Instrument QC BD FACSVia software provides an instrument QC module to check


and monitor the cytometer’s performance using BD CS&T beads.
For details on the QC screen, see Quality control (page 55).

Levey-Jennings charts are available to help you track instrument


performance parameters over time.

More information • Acquire tab (page 77)


• Setting up the worklist (page 80)
• Software preferences (page 35)
• Quality control (page 55)

Software preferences
Introduction You can set preferences for saving locations, printing reports,
applying region adjustments to all samples for a particular test,
and defining reference ranges for CD4 tests.

Save Location Use the Save Location preferences to select where you want to save
preferences the workspace and exported FCS files, reports, QC/setup, and
results CSV files.

To set Save Locations preferences:


1. Select File > Preferences.
36 BD FACSVia System Instructions for Use

The Preferences dialog opens showing the Save Locations


preferences for three categories of files and reports.

Default locations for all the file types and reports are provided.

Report/File Default location


Workspace files C:\Users\Public\Public Documents\BD Accuri
Files\FACSVia Workspaces

Exported FCS files C:\Users\Public\Public Documents\BD Accuri


Files\FCS Files

Lab reports C:\Users\Public\Public Documents\BD Accuri


Files\Lab Reports

Instrument QC C:\Cytometer Support Files\Instrument QC


reports reports

HLA Setup C:\Users\Public\Public Documents\BD Accuri


Report Files\HLA-B27 Setup Reports
Chapter 2: About the system 37

Report/File Default location


Physician report C:\Users\Public\Public Documents\BD Accuri
Files\Physician Reports

Summary report C:\Users\Public\Public Documents\BD Accuri


Files\Summary Reports

Results CSV file C:\Users\Public\Public Documents\BD Accuri


Files\Results CSV Files

2. If you wish to change the default location, click Browse and


select a new folder.

The physician and summary reports and results CSV files are
not automatically saved. If you want to save them, click the
checkbox in front of the option. Ensure that either the default
or user-selected save location appears.

If you choose not to save summary reports by default, using


the Save Summary Report preference, you can still choose to
save them later by selecting File > Save/Print Summary Report
at the completion of the run.

Note: If you want to restore the locations for any of the files
or reports within the three categories—workspace/FCS files,
reports, or test results—to the BD default locations, click
Restore BD Default Locations under the corresponding
category.

3. Click Save.

Print Preferences Use the Print Preferences to select whether to print reports. Lab
reports, Instrument QC reports, and HLA-B27 Setup reports are
automatically saved as PDF files.

To set Print Preferences:


1. Select File > Preferences.
38 BD FACSVia System Instructions for Use

2. Select Print Preferences in the left pane.

3. Select Allow printing to if you want to print reports. Then,


select a printer from the menu.

This option allows you to print the lab, physician, and


summary reports.

4. If you selected to allow printing, you can also choose to:

• Print a report after each sample and the QC results, by


selecting Automatically print before starting the next
sample.
• Automatically print a summary report at the end of a
worklist, by selecting Summary Reports. Summary reports
contain a list of all samples run in the worklist.
5. Click Save.
Chapter 2: About the system 39

Region/Gate Use the Region/Gate Settings preferences to apply the changes you
Settings make to a region to all tests within that workspace and all future
preferences tests. You can also use this preferences dialog to restore the BD
default regions at any time.

To set Region/Gate Settings preferences:


1. Select File > Preferences.

2. Select Region/Gate Settings in the left pane.

3. Select the region adjustment option for the appropriate test.


This option applies only to the tests shown, and then only if
they are installed on your system.

Each time you update a region for a selected test, the updated
region settings will be used as the default. To always use the
BD defaults, leave the checkbox blank.
40 BD FACSVia System Instructions for Use

Note: If you want to restore the region adjustments to the BD


defaults for the current worklist, click Restore BD Default
Regions.

4. Click Save.

Reference Ranges Use the Reference Ranges preferences to enter reference ranges for
preferences the BD Tritest and BD Multitest CD4 tests you perform.

To set Reference Ranges preferences:


1. Select File > Preferences.

2. Select Reference Ranges in the left pane.

3. Click the appropriate tab and enter the minimum and


maximum reference range values for each result for the given
reagent.

You can enter up to two reference ranges for each result.

4. Enter a name for the reference range or leave the default.


Chapter 2: About the system 41

5. If you want the reference ranges to be displayed on the lab and


physician reports, select Display on reports.

More information • Adjusting regions (page 96)


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3
Startup and shutdown
This chapter covers the following topics:

• Startup workflow (page 44)


• Filling the fluid bottles (page 44)
• Emptying the waste bottle (page 47)
• Starting up the system (page 49)
• Shutting down the system (page 52)
44 BD FACSVia System Instructions for Use

Startup workflow
Introduction This topic describes the workflow for daily system startup.

Workflow The following table lists the tasks that should be performed each
day to start up the system and prepare it for running samples.

Step See
1 Filling the fluid bottles (page 44)

2 Emptying the waste bottle (page 47)

3 Starting up the system (page 49)

More information • BD FACSVia cytometer overview (page 18)

Filling the fluid bottles


Introduction This topic describes how to fill the sheath, cleaning solution, and
detergent solution bottles.

About the fluid Visually check all the bottles at the start of each day and fill the
bottles sheath, BD FACSClean, and detergent solution bottles, as needed.

The cytometer is a non-pressurized system. If necessary, any of the


bottles can be opened while the cytometer is powered on.
However, avoid filling the fluids during startup, shutdown,
acquisition, and the cleaning cycles.
Chapter 3: Startup and shutdown 45

The software displays a message when a fluid bottle needs


attention.

Caution: Always fill or empty the fluid bottle when the


message appears. Allowing the bottle to run dry can
introduce air in the lines and lead to problems with the
fluidics system.

Required materials The following fluids are used with the system:

Bottle name Fluid solution


Sheath 0.2-µm filtered DI water with BD™ Sheath
Additive

BD FACSClean BD FACSClean cleaning solution

Detergent Solution BD™ Detergent Solution Concentrate

Caution: Corrosive! BD FACSClean solution contains


chemicals which may be harmful and can cause skin and
eye irritation. Use universal precautions when handling.

Before you begin Prepare the following solutions:

• Working solution of the Detergent Solution Concentrate


Add 3 mL of Detergent Solution Concentrate to 197 mL of
filtered DI water. Use the working solution within 2 weeks.

• Sheath fluid
Add one bottle (5 mL) of Sheath Additive to 1 liter of 0.2-µm
filtered DI water.
46 BD FACSVia System Instructions for Use

Procedure To fill the fluid bottles:


1. Disconnect each color-coded line from the top of the bottle by
squeezing the quick-connect fitting and pulling the tubing
connector out of the fitting.

2. Remove the cap from each bottle.

3. Fill each bottle with the appropriate fluid. Add:

• 2 L of filtered DI water with Sheath Additive to the sheath


fluid bottle (blue)
• 250 mL of BD FACSClean solution to the BD FACSClean
bottle (yellow)
• 250 mL of detergent (working) solution to the Detergent
Solution bottle (green)
4. Replace the caps on the fluid bottles.

5. Snap the color-coded tubing back into place by pushing firmly


until you hear a click.

Next step Emptying the waste bottle (page 47)

More information • Fluidics components (page 22)


• Startup workflow (page 44)
Chapter 3: Startup and shutdown 47

• Emptying the waste bottle (page 47)


• Replacing the fluid bottle filters (page 113)

Emptying the waste bottle


Introduction This topic describes how to safely empty the waste bottle.

About the waste Empty the waste bottle daily or when prompted by the software to
bottle prevent spillover and possible biological safety risk.

The cytometer is a non-pressurized system. If necessary, you can


empty the waste while the cytometer is powered on.

Caution: Biohazard! Always use precautions when


handling biological specimens or instruments that enter
in contact with specimens. Wear suitable protective
clothing, eyewear, and gloves. Dispose of waste using
proper precautions and in accordance with local
regulations.

Required materials • 200 mL of undiluted bleach

Procedure To empty the waste bottle:


1. Disconnect both connectors—waste tubing and fluid sensor—
from the top of the waste bottle by squeezing the quick-
48 BD FACSVia System Instructions for Use

connect fittings and pulling the tubing connectors out of the


fittings.

2. Carefully remove the cap.

3. Dispose of waste using proper precautions and according to


local, state, and country biohazard handling regulations.

4. Add approximately 200 mL of undiluted bleach to the bottle.

5. Replace the cap.

6. Snap the tubing back into place by pushing each connector


firmly into its color-coded fitting until you hear a click.

Next step Starting up the system (page 49)

More information • Fluidics components (page 22)


• Startup workflow (page 44)
• Filling the fluid bottles (page 44)
• Replacing the fluid bottle filters (page 113)
Chapter 3: Startup and shutdown 49

Starting up the system


Introduction This topic describes how to turn on the cytometer and start
BD FACSVia clinical software. You can turn on the cytometer and
computer in any order.

Before starting the Check the fluid levels in all bottles.


cytometer
• Fill the sheath bottle. See Filling the fluid bottles (page 44).
• Check the fluid levels in the BD FACSClean and detergent
solution bottles. Fill them, if necessary.
• Empty the waste bottle. See Emptying the waste bottle
(page 47).
• If running samples manually, adjust the height of the sample
stage, if necessary. See Adjusting the height of the sample stage
(page 25).

About startup During startup—while the lasers warm up and the fluid lines are
flushed with fresh sheath fluid—the cytometer power indicator
flashes blue and the software traffic light turns yellow. This process
takes approximately 15 minutes.

If you see the following message during startup, the cytometer


takes additional time to run the Clean Fluidics cycle. The startup
time can take approximately 25 minutes.

Extra startup time needed due to cleaning or improper shutdown.

If the power and event indicator lights both flash, see Hardware
troubleshooting (page 138).

Note: Do not open the lid of the cytometer during the startup
process. Opening the lid interrupts the laser warm-up and extends
the time before samples can be acquired.

Required materials • 2 mL of BD FACSClean solution (Loader only)


• 2 mL of DI water
50 BD FACSVia System Instructions for Use

Starting the To start up the cytometer when running manually:


cytometer when 1. Ensure a tube containing at least 2 mL of DI water is loaded
running manually on the SIP. If necessary:

a. Push the sample stage back.


b. Place the tube of water over the SIP.
c. While holding the tube, pull the sample stage forward to
support the tube.
2. Press the power button on the front of the cytometer to turn it
on.

Once the fluid lines are flushed, the traffic light turns green
and the software displays the message Cytometer is connected
and ready. The power indicator on the front of the cytometer
turns solid blue.

Starting the To start up the cytometer when using the Loader:


cytometer when 1. Press the power button on the front of the cytometer to turn it
using the Loader on.

Once the lasers are warmed up and the fluid lines are flushed,
the traffic light turns green and the software displays the
message Cytometer is connected and ready. The power
indicator on the front of the cytometer turns solid blue.

2. Click Eject Rack and load the following fresh cleaning tubes in
the designated fixed locations on the Loader tray:

Caution! Do not add more than 2 mL of fluid to the


tubes. Do not overfill.

• A tube with 2 mL of BD FACSClean in the triangle ( )


• A tube with 2 mL of DI water in the circle ( )
• A tube with 2 mL of DI water in the square ( )
3. Click Load Rack.
Chapter 3: Startup and shutdown 51

Opening To open BD FACSVia clinical software and sign in:


BD FACSVia clinical 1. Turn on the power to the computer.
software
2. Double-click the BD FACSVia clinical software icon on the
computer desktop.

The sign in dialog opens.

3. Enter your user name and password and click OK.

More information • Filling the fluid bottles (page 44)


• Emptying the waste bottle (page 47)
• BD FACSVia cytometer overview (page 18)
• BD FACSVia Loader overview (page 26)
• Shutting down the system (page 52)
• Cleaning the fluidics (page 110)
• Performing a SIP clean (page 108)
52 BD FACSVia System Instructions for Use

Shutting down the system


Introduction This topic describes how to exit the software and turn off the
cytometer. You can turn off the cytometer and computer in any
order.

About shutdown When you turn off the power to the cytometer, the Clean Fluidics
cycle is run automatically. The cycle takes about 13 minutes to
complete. See Cleaning the fluidics (page 110) for details. At the
end of the cycle, leave the SIP in the tube of water to keep it from
drying out.

Clean the sample stage at shutdown and whenever you see stains
or spills on it.

Depressing the power button for 3 seconds or longer bypasses the


automatic Clean Fluidics cycle. If you shut down the cytometer in
this way, it does not get properly cleaned, and the software
displays the following message the next time you turn on the
cytometer:

Extra startup time needed due to cleaning or improper shutdown.

When this occurs, the cytometer takes additional time to run the
Clean Fluidics cycle at startup. The startup time can take
approximately 25 minutes.

Shutting down the To shut down the cytometer when running manually:
cytometer when 1. Use a disposable towel or wipe moistened with BD FACSClean
running manually or a 10% bleach solution to wipe down the sample stage.
Follow with a wipe moistened with water.

2. Place a tube containing 2 mL of DI water on the SIP.

a. Push the sample stage back.


b. Place the tube of water over the SIP.
c. While holding the tube, pull the sample stage forward to
support the tube.
Chapter 3: Startup and shutdown 53

3. Press the power button on the front of the cytometer to turn it


off. Leave the tube of water on the SIP.

The Clean Fluidics cycle runs for approximately 13 minutes, then


the cytometer automatically powers off.

Shutting down the To shut down the cytometer when using the Loader:
cytometer when 1. Ensure the following cleaning tubes are loaded in the
using the Loader designated fixed locations on the Loader tray:

• A tube with 2 mL of BD FACSClean in the triangle ( )


• A tube with 2 mL of DI water in the circle ( )
• A tube with 2 mL of DI water in the square ( )
2. Press the power button on the front of the cytometer to turn it
off. The SIP is left in the tube of water in the square ( )
location.

The Clean Fluidics cycle runs for approximately 13 minutes, then


the cytometer automatically powers off.

Exiting the To exit the software:


software 1. Select File > Quit.

2. Click Yes when prompted to save changes to the workspace.

More information • Cleaning the fluidics (page 110)


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4
Quality control
This chapter covers the following topics:

• QC overview (page 56)


• Running instrument QC (page 58)
• Adjusting the bead regions and markers (page 62)
• Viewing QC results (page 67)
• Viewing Levey-Jennings plots (page 72)
56 BD FACSVia System Instructions for Use

QC overview
Introduction This topic describes the quality control module and recommended
workflow.

About quality The instrument QC module allows you to perform quality control
control on the system. Run quality control daily using the BD CS&T beads
to check and monitor the instrument’s performance. The CS&T
beads have a known median fluorescence intensity (MFI) and
distribution (rCV), and allow you to characterize, track, and report
measurements made by the cytometer.

During instrument QC, the software sets regions around the dim
beads and the mid + bright beads. The locations of the regions are
based on target values, not on the actual locations of the bead
populations. The system measures the brightness and distribution
of the bright beads and compares the results to expected values.
Instrument sensitivity is also calculated. In addition, the
compensation values are updated based on the CS&T bead results,
eliminating the need for additional compensation controls or
adjustments. When the QC test is complete, a Passed or Failed
result is displayed.

Process controls If available, run controls specific for each assay each day after
instrument QC to check the staining procedure and accuracy of the
reagents. Prepare and run controls along with the test samples,
according to the instructions in the reagent kit instructions for use.
Chapter 4: Quality control 57

Daily workflow The following table shows the recommended daily workflow for
running QC, controls, and samples.

Step Description
1 Prepare CS&T beads according to the BD CS&T Beads
instructions for use.

2 Run BD CS&T beads and optimize the regions and


markers. See Running instrument QC (page 58) and
Adjusting the bead regions and markers (page 62).

3 Prepare controls and samples together. See the appropriate


reagent kit instructions for use.

4 Run controls and test samples. See Data acquisition


(page 75).

5 Review the results and adjust regions, if necessary. See


Reviewing reports (page 91) and Adjusting regions
(page 96).

More information • Running instrument QC (page 58)


• Viewing QC results (page 67)
• Viewing Levey-Jennings plots (page 72)
58 BD FACSVia System Instructions for Use

Running instrument QC
Introduction This topic describes how to run the BD CS&T beads to check the
instrument performance before running controls and samples.

When to run Check the instrument performance every day before using the
instrument QC system. This ensures that the instrument is working properly
before you run controls and samples.

Current QC status The current QC result and the time elapsed since the test was run
appear in the upper-right corner of the Acquire tab.

Note: If the last QC test failed or was run more than 24 hours ago,
a dialog opens when you sign into the software, prompting you to
run QC. This dialog is displayed before each sample you run.

Before you begin Prepare BD CS&T beads according to the instructions in the
BD CS&T Beads instructions for use.
Chapter 4: Quality control 59

Procedure To run instrument QC:


1. Click Instrument QC in the upper-right corner of the
workspace.

The QC module opens.

2. Select the bead lot from the BD CS&T Bead Lot menu.

The last bead lot run appears as the default.

If you need to install a bead lot file for a new lot of beads, see
Install a new bead lot (page 60).

3. Enter your operator ID and the lab director ID.

Once the lab director ID is entered, it becomes the default until


you change it.
60 BD FACSVia System Instructions for Use

4. Run the CS&T beads.

• If you are running bead samples manually, mix the tube of


CS&T beads and load it on the instrument. Click RUN.
• If you are using a Loader, click Eject Rack. Mix the tube of
CS&T beads and place it in location A1. Place the tube
rack on the Loader and click RUN.
5. Wait for acquisition to complete.

The system starts by measuring the background instrument


noise. During this step, the Instrument Noise Measurement
plots are displayed.

After assessing the noise, the system acquires 25,000 events


and displays the BD CS&T Bead plots.

If you want to abort the run, click ABORT QC.

When acquisition is complete, the QC Report table is


displayed, and the result appears at the top of the screen.

6. Rinse the SIP.

If you are running manually, place a tube of DI water on the


SIP. If you are using a Loader, the instrument automatically
performs a SIP rinse.

7. Proceed to Adjusting the bead regions and markers (page 62).

Install a new bead If this is the first time you are running a bead lot, you will need to
lot install the BD CS&T bead lot file. The bead lot file contains
information specific to the given lot of beads, such as expiration
date, rCV, target MFIs, and sensitivity specifications. Once
installed, the bead lot number will be available to select from the
BD CS&T Bead Lot menu for subsequent QC runs.

To install the bead lot:


1. Select Install from the BD CS&T Bead Lot menu.
Chapter 4: Quality control 61

The Install New Bead Lot dialog opens.

2. You can either locate a bead lot file on your computer or scan
the bead lot barcode.

• To browse for a file on your computer, first download the


BD CS&T bead lot file from the BD website. Go to
bdbiosciences.com for instructions on downloading bead
lot files. Once downloaded, select Install bead lot, then
click Choose file. Navigate to the bead lot file and click
Open.
• To scan a bead lot, select Scan bead lot bar code, then scan
the bar code on the box. The bead lot appears in the space
provided.
3. Click Install.

More information • Adjusting the bead regions and markers (page 62)
• Viewing QC results (page 67)
• Removing bead lots from the CS&T bead lot menu (page 134)
• QC troubleshooting (page 147)
62 BD FACSVia System Instructions for Use

Adjusting the bead regions and markers


Introduction This topic describes how to adjust the regions and markers for the
BD CS&T beads.

The software sets the region and markers for the bright beads
based on target values, not on the actual locations of the
populations. Therefore, you will need to check and optimize the
region and markers, as necessary.

About adjusting Once the bead acquisition is complete and while the QC results are
the regions and displayed, you can adjust the regions and markers to optimize
markers them.

Note: Do not adjust the markers for the noise peaks.

Once you close the QC window to advance to the worklist, or click


on the History: Levey-Jennings tab, you can no longer return to the
Instrument QC tab to edit the regions and markers. A dialog is
displayed to remind you.
Chapter 4: Quality control 63

To adjust the regions and markers, scroll up to the bead plots, as


shown.

Adjusting the Adjust both the dim and mid + bright regions.
regions in the dot
plot To adjust the bead regions:
1. Use the zoom tool to zoom in on the bead data before
adjusting the regions. See Zooming plots (page 65).

2. Click the bead region to select it.


64 BD FACSVia System Instructions for Use

The region appears with a bold red outline and eight handles.

Unzoomed Zoomed

3. Adjust the region for the dim beads and the region for the
mid + bright beads. Exclude the doublet population to the
right of the mid + bright beads.

• Place the cursor over a handle. A double-sided arrow


appears. Click and drag to adjust the region in either
direction. When you adjust a corner handle, the region
automatically snaps to a rectangle.
• Place the cursor over an area that is not a handle. A four-
sided arrow appears. Click and drag to move the entire
region in any direction.
If you want to revert to the original regions, click Undo Manual
Adjustments in the upper-right corner of the screen.

Adjusting the To adjust the bright-bead peak markers in all four histograms:
markers in the 1. Use the zoom tool to zoom in on the bead populations before
histogram plots adjusting the markers. See Zooming plots (page 65).

2. Click the bright bead marker to select it.


Chapter 4: Quality control 65

The marker appears with a bold red outline and two handles.

Unzoomed Zoomed

3. Adjust the markers.

• Place the cursor over a handle to drag it to the left or right.


• Place the cursor over the horizontal line between the
handles to move the entire marker in any direction.
4. Repeat as necessary to adjust the marker to encompass the
bright bead population, while excluding the doublets.

If you want to revert to the original markers, click Undo Manual


Adjustments in the upper-right corner.

Zooming plots You can zoom in on data to make it easier to see where to set the
markers. If the plots are zoomed when you close the QC report,
the report will be saved with the zoomed plots.

To zoom the plot:


1. Click the zoom tool below the plot to zoom in on the data.

zoom expand
tool tool
66 BD FACSVia System Instructions for Use

2. Click and drag over the area that you want to zoom in on.
Repeat as necessary.

• To zoom a dot plot, drag in any direction to encompass the


population of interest.
• To zoom a histogram, drag across the peak in either
direction.
Unzoomed Zoomed

3. Click the expand tool to zoom out once. Or, click the Default
Zoom button to go back to the original data range.

Next step • If the result passed, you are ready to run controls, followed by
test samples. See Data acquisition (page 75). Prepare the
controls along with the test samples. See the appropriate
reagent kit instructions for use for sample preparation
information.
• If the result failed, even after you adjusted the bead regions
and markers, check the QC messages for additional help. See
QC troubleshooting (page 147) for possible causes and
solutions.
• To rerun the beads, mix the tube, click New QC, then click
RUN.
Chapter 4: Quality control 67

Viewing QC results
Introduction This topic describes the information that appears on the QC results
screen.

About instrument The instrument QC results are displayed as Passed or Failed. If the
QC results result fails, adjust the mid + bright bead region and the
fluorescence markers. The QC messages that appear below the QC
Report (results) table provide information on the conditions that
the system encountered.

Caution! Do not run process controls or test samples if


instrument QC fails. A successful instrument QC is
required to ensure accurate results.

QC results screen While the QC results window is open, you can make adjustments
to the regions and markers to optimize them. See Adjusting the
bead regions and markers (page 62). Once you close the window
to advance to the worklist or click on the History: Levey-Jennings
tab, the QC results are locked and no longer editable; however you
can add comments. You can also open and view previous reports
and enter comments.
68 BD FACSVia System Instructions for Use

Instrument noise The system measures the background instrument noise and
measurement plots displays this in the Instrument Noise Measurement plots. Markers
are automatically set in the lower channels around the target
locations for noise peaks. Do not adjust the noise peak markers.

BD CS&T Beads The system acquires 25,000 total events and displays the data in
plots the BD CS&T Beads plots. Regions are set around the dim bead
population and the mid + bright bead population in the dot plot
based on target values. Markers are set around the bright bead
target location in the histogram for each fluorescence parameter.
You can adjust the regions and/or the histogram markers. See
Adjusting the bead regions and markers (page 62) for information.

QC Report table The QC Report table displays the values and Pass/Fail result for
each parameter. If any of the results for an individual parameter
Chapter 4: Quality control 69

fails, the failed parameter result appears in red and the overall
instrument QC result fails.

The QC Report table provides values for the following


measurements for FSC, SSC, and FL1–FL4 parameters.

Measurement Description
Bright Bead Median Measured median value for the bright bead
population

MFI Range Target median scatter and fluorescence


intensity range for the bright bead population

% Bright Bead rCV rCV for the bright bead population

Instrument Sensitivity Resolution between instrument noise and


bright bead peak

Sensitivity Spec. Minimum sensitivity required

Parameter Pass/Fail Passed/Failed result for this parameter

QC Messages QC messages, listed below the QC Report table, provide


information about the run. The messages can be helpful in
troubleshooting if instrument QC fails. If there are QC messages
for the run, a QC Messages link appears below the Passed/Failed
results at the top of the screen. Click the link to quickly scroll to
the QC messages. See QC Messages in QC troubleshooting
(page 147) for more information.
70 BD FACSVia System Instructions for Use

Comments The Comments section allows you to add comments about the run.
You can also add comments before you run the beads or after the
QC window is closed, by viewing previous QC results.

To add comments to the QC report:


1. Click in the Comments text box and type the comment(s).

Viewing previous You can view the QC report for any previous QC run.
QC results
To view QC results from a previous run:
1. Click View Previous QC in the upper-right corner of the
Instrument QC tab.

A window opens showing all QC runs by date.

2. Select a run, then click OK to view the results for that run.
Chapter 4: Quality control 71

Note: Results from previous runs are not editable. However,


you can add comments to the report.

Printing QC reports You can print QC reports after the run is complete. You can also
print the reports from previous QC runs. To print the report you
must have the print preference in the Preference dialog selected.

To print the QC report:


1. Click Print in the upper-right corner of the QC window.

Note: If the button in the upper-right corner is Save PDF, then the
print preference is not selected. See Software preferences (page 35)
for information on selecting the correct preference.

Next step • If instrument QC passed, you are ready to run controls and
test samples. See Data acquisition (page 75). Prepare the
control along with the test samples. See the appropriate
reagent kit instructions for use for sample preparation
information.
• If instrument QC still fails after adjusting regions and markers,
check the QC messages at the bottom of the screen for more
information. Refer to QC troubleshooting (page 147) for
possible causes and solutions.

More information • Software preferences (page 35)


• Running instrument QC (page 58)
• Adjusting the bead regions and markers (page 62)
• Viewing Levey-Jennings plots (page 72)
• Removing QC report files from the history list (page 133)
72 BD FACSVia System Instructions for Use

Viewing Levey-Jennings plots


Introduction This topic describes the History: Levey Jennings tab used to view a
history of QC results and print Levey-Jennings reports.

About Levey- Levey-Jennings reports track QC data over time, allowing you to
Jennings reports view the system’s performance and ensure that the system is
reproducing consistent results. The graphs in the report show you
random errors or shifts and trends in the data for each parameter,
and help you diagnose possible problems with the system.

The graphs show the bright bead median values, %rCV, and
sensitivity with standard deviations for FSC, SSC, FL1, FL2, FL3,
and FL4.

Reviewing the To view the Levey-Jennings report:


Levey-Jennings 1. Select File > View History: Levey-Jennings.
report
If you are in the QC module, click the QC History: Levey-
Jennings tab.

The Levey-Jennings tab is displayed.


Chapter 4: Quality control 73

2. Select the number of days from the View menu in the upper-
left corner of the tab.

You can view data for the last 30, 60, or 90 days. Use the
scroll arrows to the right of the View menu to change the start
date.

• Click the left arrow to select a date 1 month earlier.


• Click the right arrow to select a date 1 month later.

3. Scroll down to view all the graphs for FL1–FL4, FSC, and SSC
median, FL1–FL4 rCVs, and sensitivity for each parameter.
74 BD FACSVia System Instructions for Use

The graphs show CS&T bead data plotted over time. If


multiple bead lots were used, a different symbol and different
color line appear for each lot.

The horizontal lines above and below the median line


represent ±1 SD and 2 SD. The top and bottom edges of the
graph represent ±3 SD.

A legend in the lower-left corner displays the symbols used for


invalid results, where a data point was collected but the value
was not used in the SD calculation. The different symbol
shapes correspond to the symbols used for different bead lots.

4. To close the QC window, click Close in the lower-right corner.

Printing Levey- To print a Levey-Jennings report:


Jennings reports 1. Select the number of days you want to plot from the View
menu.

2. Click Print in the upper-right corner of the Levey-Jennings tab.

More information • Viewing QC results (page 67)


• Software preferences (page 35)
• QC troubleshooting (page 147)
5
Data acquisition
This chapter covers the following topics:

• Acquisition workflow (page 76)


• Acquire tab (page 77)
• Setting up the worklist (page 80)
• Running samples manually (page 83)
• Running samples using a Loader (page 87)
• Rerunning samples (page 90)
• Reviewing reports (page 91)
• Adjusting regions (page 96)
• Adjusting the threshold (page 98)
• Adjusting compensation (page 101)
76 BD FACSVia System Instructions for Use

Acquisition workflow
Introduction This topic describes the workflow for running samples and
collecting data.

Before you begin • Prepare samples according to the instructions outlined in the
appropriate reagent kit instructions for use.
• Perform instrument QC and ensure that it passes. See Quality
control (page 55).

Acquisition Perform the following workflow steps to acquire sample data.


workflow
Step See
1 Setting up the worklist (page 80)

2 Running samples:
 Running samples manually (page 83) if you do not have a
Loader
 Running samples using a Loader (page 87) if you are
using a Loader

3 Reviewing reports (page 91)

4 Rerunning samples (page 90), if necessary


Chapter 5: Data acquisition 77

Acquire tab
Introduction This topic describes the Acquire tab in BD FACSVia clinical
software.

The Acquire tab When BD FACSVia clinical software opens, the Acquire tab is
displayed. You can also view the tab by clicking the Acquire tab if
you are viewing the Review tab. The Acquire tab consists of two
views—the Worklist View and the Plot View. The Worklist View
allows you to set up your worklist and enter information about the
samples. The Plot View displays the sample data during
acquisition.

The Acquire tab allows you to:

• Select the test.


• Enter information about the sample.
• Enter IDs for the lab director, operator, tube rack.
• Backflush and clean the SIP.
• Access the instrument QC screen.
The Acquire tab also displays real-time acquisition information
such as the number of events in the gate, the acquisition time, and
the rate at which events are being acquired (events/second).

The following figure shows the Acquire tab with the Worklist View
displayed, when acquiring with a Loader.
78 BD FACSVia System Instructions for Use

Areas of the The following table describes each of the areas and indicators in
Acquire tab the Acquire tab.

No. Area Description


1 Tube rack map Appears when using a Loader. Shows a map for a 24-tube rack with
four rows (A–D) and six tubes per row.

2 Test and sample Select the test to perform from the list of BD-defined assays.
information
Scan or manually enter sample ID, name, and case number. You must
fields
enter a sample ID.

3 Trucount bead Once you select the test, the Trucount bead information fields
information appear. Enter the bead information (Trucount lot #, bead count, and
bead expiration date) and depending on the test you are performing,
any assay-specific information.
Chapter 5: Data acquisition 79

No. Area Description


4 Laboratory IDs Enter the IDs for the operator, person preparing the samples, tube
rack (if applicable), and lab director.
Once you save the workspace, the path/file name is displayed above
the ID fields.

5 Check Displays the result from the last QC run and how long ago it was
Performance performed. Clicking Instrument QC displays the Instrument
Performance window, allowing you to perform quality control. View
History allows you to see the results from past QC runs.

6 Next button Advances to the next sample in the worklist.

7 RUN button Click to start acquiring the sample(s). Changes to PAUSE during
acquisition. For details on rerunning samples see Rerunning samples
(page 90).

8 Eject Rack Appears when using a Loader. Ejects the Loader rack, then changes
to Load Rack.

9 Acquisition Displays the following real-time information about the current or


counters most recent acquisition:
Events in gate. Number of events in the gate.
Time. Elapsed acquisition time.
Events/sec. Events acquired per second. When the run is completed,
this is the average value.

10 Backflush/SIP Backflushes fluid out of the SIP. See Backflushing the SIP (page 106).
Clean buttons
Performs an SIP clean. See Performing a SIP clean (page 108).

11 Checkboxes Allow you to automatically perform these tasks:


Run SIP Clean After Worklist. Clean the SIP at the end of the
worklist. We recommend always running a SIP clean after every
worklist.
Rinse SIP Between Samples. Rinse the SIP between each sample (for
Loader only).

12 ABORT RUN Allows you to stop acquisition for a sample during a run. If using a
button Loader, the tray ejects. A lab report is generated and a QC message
indicates that the acquisition was aborted. At the completion of the
run, you can rerun the sample and overwrite the data.
80 BD FACSVia System Instructions for Use

More information • BD FACSVia clinical software overview (page 30)


• Acquisition workflow (page 76)
• Setting up the worklist (page 80)

Setting up the worklist


Introduction This topic describes how to enter information in the worklist.
Perform this step whether you are running samples manually or
using a Loader for acquisition.

How to fill out the When entering worklist information, you can enter the values in
worklist the fields at the top of the screen; the rows in the worklist will
automatically populate. You can also enter the values directly in
the worklist table. Use the tab key to move to the next field. Click
the next row or click Next to move to the next row. The current
row is outlined in red.

Select the test from the Test menu. Or, type the first letter of the
test when the test field is highlighted. Typing the first letter
multiple times cycles through all the tests beginning with that
letter. Once the BD Trucount™ bead information is entered, the
software automatically populates the fields for each test.
Chapter 5: Data acquisition 81

Filling out the To enter information for the run:


worklist 1. Type or scan the sample ID, name, and case number.

The sample ID is required.

If you are using BD FACSLink to transfer results to a


laboratory information system (LIS), enter the sample ID and
press Enter. The test information will automatically populate.
If it does not, you can manually enter the information. If more
than one test is pending, a dialog will prompt you to select the
test. Select the test and click Add. Proceed to step 5.

2. Select the test from the Test menu.

If you are entering values within the worklist table, you can
also tab to the Test field and type the first letter of the test. For
example, type L to Leucocount.

3. Enter the BD Trucount bead information.

• Trucount lot number (this value can also be scanned)


• Bead count
• Expiration date (yyyy-mm-dd format)
The bead information will remain for subsequent sessions until
you change it.

4. Depending on the test you selected, enter any appropriate


assay-specific information. See the appropriate application
guide for more information.

5. Repeat steps 1 through 4 for the remaining samples.

6. Enter IDs for the operator, person preparing the samples, tube
rack, and lab director.
82 BD FACSVia System Instructions for Use

The tube rack ID cannot have more than five characters. The
lab director ID will remain for subsequent sessions until you
change it.

7. (Optional) Clear the checkbox next to the task you do not


want to perform:

• Run SIP Clean After Worklist


• Rinse SIP Between Samples (Loader only)
By default, these tasks are performed automatically. We
recommend always running a SIP clean after the worklist to
avoid clogs.

8. Save the worklist file.

Note: If you save the file to a location that already has a


workspace file with the same name, you will overwrite the
existing file.

a. Select File > Save.


b. Navigate to the folder where you want to save the file.
c. Enter a file name, and click Save.
You can fill out a worklist in advance and save it. Then open it
later when you are ready to run the samples.
Chapter 5: Data acquisition 83

Next step Proceed to:

• Running samples manually (page 83) if you are loading tubes


manually.
• Running samples using a Loader (page 87) if you have a
BD FACSVia Loader.

Running samples manually


Introduction This topic describes how to manually run samples. Manual
acquisition refers to the task of loading tubes by hand one at a
time. When you have finished filling out the worklist, you are
ready to start the run.

Before you begin Fill out the worklist by entering sample, BD Trucount bead, and
operator information. Or, open a saved worklist file. See Setting up
the worklist (page 80).

Procedure To run samples manually:


1. Click RUN 1.

Note: If the last QC test failed or was performed more than


24 hours ago, a dialog opens each time you press RUN,
prompting you to run QC. If the QC test failed and you ignore
the prompt, a QC message appears on all lab reports
indicating that the last QC test failed.
84 BD FACSVia System Instructions for Use

A dialog opens prompting you to load the first sample.

2. Mix the first sample and load it on the instrument.

3. Click Run Sample 1.

The Plot View is displayed showing the sample data and


acquisition count information.

4. If necessary, you can perform the following tasks during


acquisition:

• To pause acquisition, click PAUSE. Click RUN, then Run


Sample X to continue with acquisition where it left off.
• To discard the data for the current sample, click ABORT
RUN. To restart acquisition, click RUN, then Run Sample
Chapter 5: Data acquisition 85

X when prompted to load the next sample. You can go


back and rerun the aborted sample at the end of the run.
When the sample acquisition is complete, a dialog opens
prompting you to run the next sample or make adjustments to
the current sample. To make adjustments for the current
sample, click Adjust Sample. The software advances to the
Review tab allowing you to make adjustments. See Adjusting
regions (page 96) for information on adjusting regions.

If you want to rerun the sample, click Cancel and see


Rerunning samples (page 90).

5. Mix and load the next sample and click Run Sample 2.

6. Continue running samples. When acquisition for the last


sample is complete, click Done.

If a red exclamation point appears next to a sample number in


the worklist, a hardware fault error occurred. Data for the
sample is not available for review and a lab report is not
generated. See Hardware fault errors (page 141) for a list of
errors.

At the completion of the run, the system performs a SIP clean


if the Run SIP Clean After Worklist checkbox is selected. You
will be prompted for a tube of BD FACSClean followed by a
tube of water.
86 BD FACSVia System Instructions for Use

7. If the Run SIP Clean After Worklist checkbox is not selected,


perform a SIP clean manually by selecting SIP Clean and
following the prompts. See Performing a SIP clean (page 108)
for more information. Leave a tube of DI water on the SIP.

Next step • To run another worklist:


– Select File > New BD FACSVia workspace to open a new
workspace.
– Select File > Open BD FACSVia workspace to open a saved
workspace.
The software prompts you to save the current workspace
before opening a new workspace. Select Yes to save.

• To rerun a sample, see Rerunning samples (page 90).


• To view lab reports, see Reviewing reports (page 91).
• If you are finished running samples for the day, see Shutting
down the system (page 52).

More information • Setting up the worklist (page 80)


• Adjusting regions (page 96)
• Performing a SIP clean (page 108)
• Rerunning samples (page 90)
• Shutting down the system (page 52)
Chapter 5: Data acquisition 87

Running samples using a Loader


Introduction This topic describes how to run samples using the Loader. The
Loader automatically agitates the rack and loads the sample tubes
onto the cytometer from the rack. When you have finished filling
out the worklist, load the tube rack, and you are ready to start the
run.

Before you begin • Fill out the worklist by entering sample, BD Trucount bead,
and operator information. Or, open a saved worklist file. See
Setting up the worklist (page 80).
• Ensure the following cleaning tubes are loaded in the
designated locations on the Loader tray:
– 2 mL of BD FACSClean in the triangle ( )
– 2 mL of DI water in the circle ( )
– 2 mL of DI water in the square ( )

Procedure To run samples using the Loader:


1. If necessary, click Eject Rack and load the tube rack on the
Loader.

Position A1 goes in the upper-left corner.

Note: Ensure that sample tubes contain no more than 2.5 mL


of fluid.

2. Click RUN A1.

Note: If QC failed the last time it was run, a dialog opens each
time you press RUN, prompting you to run QC. If you ignore
the prompt, a message appears on all lab reports indicating
that the last QC test failed.
88 BD FACSVia System Instructions for Use

The Plot View is displayed showing the sample data and


acquisition count information. The position in the tube rack
map flashes blue for the sample that is currently being
acquired.

3. If necessary, you can perform the following tasks during


acquisition:

• To pause acquisition, click PAUSE. Click RUN, then Run


Sample X to continue with acquisition where it left off.
• To discard the data for the current sample, click ABORT
RUN. Load the rack, then click RUN X to start acquisition
for the next sample. You can go back and rerun the aborted
sample at the end of the run.
The system automatically continues acquisition for the
remaining samples, agitating the rack before each acquisition.

If the Rinse SIP Between Samples checkbox is selected, the


system will rinse the SIP between each sample. The system
automatically agitates the tube rack between samples.

If a red exclamation point appears next to a sample number in


the worklist, a hardware fault error occurred. Data for the
Chapter 5: Data acquisition 89

sample is not available for review and a lab report is not


generated. See Hardware fault errors (page 141) for a list of
errors.

At the completion of the run, the system performs a SIP clean


if the Run SIP Clean After Worklist checkbox is selected. You
will be prompted to load a tube of BD FACSClean and a tube
of water.

4. If the Run SIP Clean After Worklist checkbox is not selected,


perform a SIP clean manually by selecting SIP Clean and
following the prompts. See Performing a SIP clean (page 108)
for more information.

5. If you plan to run another worklist, change the cleaning tubes


by clicking Eject Rack, replacing the tubes, then clicking Load
Rack.

Next step • To run another worklist:


– Select File > New BD FACSVia workspace to open a new
workspace.
– Select File > Open BD FACSVia workspace to open a saved
workspace.
The software prompts you to save the current workspace
before opening a new workspace. Select Yes to save.

• To rerun a sample, see Rerunning samples (page 90).


• To view lab reports, see Reviewing reports (page 91).
• If you are finished running samples for the day, see Shutting
down the system (page 52).

More information • Setting up the worklist (page 80)


• Loading a rack (page 27)
• Performing a SIP clean (page 108)
• Rerunning samples (page 90)
• Shutting down the system (page 52)
90 BD FACSVia System Instructions for Use

Rerunning samples
Introduction This topic describes how to rerun a sample in the worklist after the
completion of the worklist. If you selected to automatically clean
the SIP at the end of the worklist, you must wait for this to
complete before you can rerun samples.

If you are running manually, you can rerun a sample immediately


after acquisition for that sample is complete. Or, wait until
acquisition for all samples in the worklist is complete. If you are
using a Loader, you need to wait until the worklist is complete
before you can rerun a sample.

Procedure To rerun a sample:


1. Click the Worklist View tab to return to the worklist.

2. Select On under Rerun in the upper-left corner of the tab.

Checkboxes are displayed in front of each sample entry.

3. Click the checkbox(es) for the sample(s) you want to rerun.

4. Click RUN.

A dialog opens warning you that rerunning the selected


samples will delete the current data.

Caution! Rerunning a sample will delete the data


previously collected for that sample.

5. Click Continue to rerun the sample(s). If running manually,


follow the prompts to load and run the samples.
Chapter 5: Data acquisition 91

More information • Running samples manually (page 83)


• Running samples using a Loader (page 87)

Reviewing reports
Introduction This topic describes how to select and view reports.

About reports Lab reports


Lab report PDFs are saved automatically at the completion of the
run. To view the reports for samples from a previous run, open the
appropriate workspace. The lab report contains all the sample
information entered in the worklist and shows the data plot(s),
results, and any QC messages pertaining to the sample. See Lab
report (page 92).

While viewing the report at the Review tab, you can:

• Adjust the regions


• Enter comments
• Mark the report as reviewed
• Adjust the threshold and/or compensation

Physician and summary reports


Physician and summary reports are not saved automatically. If you
want to save PDFs of these reports at the completion of the run,
select the report in the Save Locations preferences. See Save
Location preferences (page 35).

See Physician report (page 94) and Summary report (page 95) for
more information about these reports.
92 BD FACSVia System Instructions for Use

Lab report You can view lab reports from within the software or you can open
the PDF of the lab report by accessing the report from the folder
where lab reports are saved. See Save Location preferences
(page 35).

To view a lab report from within the software:


1. Do one of the following:

• To view a report at the completion of the run, click the


Review tab.
• To view a report for sample data from a previous run,
select File > Open BD FACSVia workspace, select the
workspace, and click Open.
2. Select the ID and test for the sample report you want to view
from the View report for ID menu.

The menu shows you all the samples contained in the current
workspace. If an ID appears red, a critical error occurred. See
the QC messages listed below the results for information on
the error. A QC Messages link in the upper-right corner of the
screen shows you the QC messages. See the appropriate
application guide for information on how to troubleshoot QC
messages.

The report for the selected sample opens. The following figure
shows an example of a Leucocount report.
Chapter 5: Data acquisition 93

3. Review the QC messages, if applicable.

4. (Optional) Adjust the regions, if necessary. See Adjusting


regions (page 96) for general instructions.

For details on adjusting the regions for a specific test, see the
appropriate application guide.

5. (Optional) Enter comments about the sample or data.

6. When you are finished reviewing the report, select the


Reviewed checkbox in the upper-right corner. Type your name
or initials, indicating the review was completed.

A time-stamp will be associated with the review and sign-off.

Note: Reports for sample IDs appearing in red must be


reviewed before they can be sent to the LIS using
BD FACSLink software.

7. Continue reviewing the remaining samples in the worklist. Use


the arrows on either side of the “sample ID - test name” that
appears under the Review tab to scroll through the sample list.
94 BD FACSVia System Instructions for Use

8. BD FACSLink users, select Send Results. Select the files to send


or select All, then click Send.

9. Click Print or Save PDF. This step will vary depending on the
print preference you have selected.

• If you have selected to print reports automatically, the lab


report will print when sample acquisition is complete.
• If you want to manually print after reviewing, select Print,
then select the samples you want to print from the Print
Options dialog and click Print.
• If you did not select the print preference, click Save PDF,
then select the samples you want to save from the Save
Options dialog or select All, and click Save.

Physician report A physician report is a PDF file that contains the sample
information entered at the worklist, results, and reference ranges, if
you entered reference ranges in the reference range preferences. It
does not contain data plots. One physician report is created for
each sample in a worklist. Physician reports are not saved for the
Leucocount, Plasma Count, or HLA-B27 assay.

Physician reports are saved in the location set in the Save Location
preferences. See Save Location preferences (page 35).
Chapter 5: Data acquisition 95

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contains the sample information entered at the worklist and the
date and time the sample was acquired. It does not contain data
plots or results.

Summary reports are saved in the location set in the Save Location
preferences. See Save Location preferences (page 35). You can
choose to automatically print a summary report at the end of the
run. See Print Preferences (page 37).
96 BD FACSVia System Instructions for Use

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More information • Adjusting regions (page 96)


• Adjusting the threshold (page 98)
• Adjusting compensation (page 101)
• Save Location preferences (page 35)
• Reference Ranges preferences (page 40)
• Selecting the report language (page 135)

Additional See the appropriate application guide for information on QC


information messages associated with the test.

Adjusting regions
Introduction This topic describes how to adjust the default regions that are
automatically set for the selected test during acquisition.

You can adjust the regions from the Review tab while viewing the
report at the completion of the run. You can also view sample data
and adjust regions at a later date by opening a saved workspace
file.
Chapter 5: Data acquisition 97

For detailed information on adjusting regions for a particular test,


see the appropriate application guide.

Procedure To adjust regions:


1. Click the region to select it.

It appears with a bold outline and handles (examples shown).

2. Adjust the region(s):

• To adjust the size of a region in any direction, place the


cursor over a handle. A double-sided arrow or cross-hairs
appear, depending on the region shape. Click and drag in
the appropriate direction. When you adjust a corner handle
of a rectangular region, the region automatically snaps
back to a rectangle.
• To move an entire region in any direction, place the cursor
over an area that is not a handle. A four-sided arrow
appears. Click and drag to move the region.
• To rotate an elliptical region, place the cursor over one of
the eight corner handles until you see a curved double-sided
arrow. Click and drag to rotate the region.
The event counts and results are automatically updated.

Enlarge the data, if necessary. See Zooming plots (page 65) for
information.
98 BD FACSVia System Instructions for Use

3. If you are adjusting the regions during a manual acquisition,


click Continue to proceed with acquisition.

4. If you want to revert back to the BD default settings:

• For Leucocount and Plasma Count, select File >


Preferences, then select Region/Gate Settings in the left
panel, and click Restore BD Default Regions.
• For Tritest, Multitest, and HLA-B27, select Undo Manual
Adjustments in the upper-right corner of the Review tab.
Note: Not all assays are available in every region/country.
Consult your local BD representative for the assays available
in your region.

5. To scroll to the previous or next sample in the worklist, click


the arrows on either side of the sample ID.

More information • Running samples manually (page 83)


• Region/Gate Settings preferences (page 39)
• Zooming plots (page 65)

Adjusting the threshold


Introduction This topic describes thresholds and gives instructions for adjusting
the threshold.

About thresholds A threshold sets a channel number below which events will not be
processed. Use thresholds to filter out unwanted events, such as
debris and noise. You can set a primary threshold and a secondary
threshold.
Chapter 5: Data acquisition 99

The primary threshold is the parameter that triggers data


collection. This parameter varies with each test. You can optionally
set a secondary threshold to filter out additional events.

Caution Keep in mind when setting the thresholds before


or during data acquisition that any event not meeting the
threshold criteria will not be acquired or saved. When
changes are made to the threshold values after data
collection, the software displays a warning message if the
new threshold value will result in permanent data loss.

When to adjust the The threshold setting for each test is automatically set by the
threshold software and should not have to be changed. However, you can
adjust the threshold setting during a run from the Plot View tab in
the Acquire tab, or at the end of the run from the Review tab.

Adjusting the To adjust the threshold:


threshold 1. Select Instrument > Set Threshold.

2. In the Threshold Settings dialog, select the primary threshold


parameter from the Primary Threshold list.

3. Enter a threshold value, either lower or higher than the


default.

A lower value will allow more events to be collected, while a


higher value will eliminate events. If you are adjusting the
threshold after the sample has been acquired, lowering the
100 BD FACSVia System Instructions for Use

threshold will have no effect; while raising the threshold will


permanently delete events.

4. If you want to apply a secondary threshold for filtering out


more data, do the following:

a. Select the threshold parameter from the Secondary


Threshold list.
b. Type a value in the less than edit box to set the threshold
minimum.
Note: Keep in mind you can view only the default parameters
that are displayed for any given test. Do not set a threshold for
a parameter that you cannot view in the plots.

5. Click Apply to apply the threshold settings to the current


sample only.

To apply the threshold settings to all samples, including


samples already run and samples not yet run, select the Apply
to all test name in worklist checkbox before clicking Apply.

6. Click Close to close the dialog.


Chapter 5: Data acquisition 101

Adjusting compensation
Introduction This topic describes compensation and gives instructions for
adjusting the compensation.

About Compensation allows you to remove fluorescence spillover from a


compensation particular parameter. Fluorescence spillover occurs because
fluorochromes emit light over a range of wavelengths. This results
in the fluorescence signal of one fluorochrome appearing not only
in the detector where it is measured, but in other detectors as well.
Compensation allows you to subtract a percentage of the
fluorescent signal, measured in one detector, from the other
detectors.

When to adjust Default compensation values are set for each instrument and
compensation updated during instrument QC. You should not need to adjust the
compensation values for any of the tests. However, during
acquisition, you can pause the sample to adjust the compensation
from the Plot View tab in the Acquire tab. Or, during analysis, you
can adjust the compensation from the Review tab.

Adjusting To adjust compensation:


compensation 1. Select Instrument > Set Color Compensation.
102 BD FACSVia System Instructions for Use

2. Ensure the correct sample is displayed in the Change


Compensation for field at the top of the dialog.

3. Enter the new compensation value(s) in the appropriate boxes.

4. Click Apply to apply the changes to the current sample only.

To apply the compensation settings to all samples, including


samples already run and samples not yet run, select the Apply
to all test name in worklist checkbox before clicking Apply.

5. If you wish to return to the original compensation settings set


by the software after instrument QC, click Reset to BD
Defaults.

6. Click Close to close the dialog.


6
Maintenance
This chapter covers the following topics:

• Maintenance schedule (page 104)


• Cleaning the outside of the instrument (page 106)
• Backflushing the SIP (page 106)
• Performing a SIP clean (page 108)
• Cleaning the fluidics (page 110)
• Running an extended flow cell clean (page 110)
• Cleaning the fluid bottles (page 112)
• Replacing the fluid bottle filters (page 113)
• Replacing the in-line sheath filter (page 114)
• Replacing the peristaltic pump tubing (page 116)
• Purging the fluid sensor lines (page 119)
• Unclogging the SIP (page 121)
• Aligning the Loader after a collision (page 124)
• Restarting the system after storage (page 126)
104 BD FACSVia System Instructions for Use

Maintenance schedule
Introduction This topic provides a list of daily, scheduled, and unscheduled
maintenance procedures.

Daily maintenance Daily maintenance is part of the startup and shutdown procedures.
See Starting up the system (page 49) and Shutting down the system
(page 52). Additionally, the following procedures can be
performed as needed.

Task When to perform


Backflushing the SIP (page 106) When you suspect a clog in the SIP

Performing a SIP clean At the completion of every


(page 108) worklist or more often if desired

Cleaning the fluidics (page 110) Occurs automatically during


shutdown

Scheduled A dialog is displayed every 2 months (or when 35 L of sheath fluid


maintenance has been used) to remind you to perform scheduled maintenance.
When the dialog appears, complete the maintenance, select the
maintenance complete option, and click OK. If you select Remind
me later, the message will appear again in 5 days.
Chapter 6: Maintenance 105

Scheduled maintenance should be performed as described in the


following table.

Task When to perform


Replacing the fluid bottle filters (page 113) Every 2 months

Replacing the in-line sheath filter Every 2 months


(page 114)

Replacing the peristaltic pump tubing Every 2 months


(page 116)

Cleaning the fluid bottles (page 112) Once a month

Unscheduled Perform the following procedures as needed.


maintenance
Task When to perform
Cleaning the outside of the At the end of each day or as
instrument (page 106) needed

Filling the fluid bottles (page 44) As needed or when prompted by


the software

Emptying the waste bottle As needed or when prompted by


(page 47) the software

Running an extended flow cell When instructed by tech support


clean (page 110) or if you notice a decrease in
instrument sensitivity
106 BD FACSVia System Instructions for Use

Cleaning the outside of the instrument


Introduction This topic describes how to wipe down the instrument.

Required materials • DI water


• 10% bleach solution, BD FACSClean solution, or 70%
ethanol
• Paper towels or disposable wipes

Procedure To wipe down the outside of the instrument:


1. Moisten a paper towel with the cleaning solution.

2. Wipe down the outside panels and the sample stage. If you
have a Loader, wipe down the Loader tray and mat.

3. Moisten a clean paper towel with DI water and wipe the areas
you wiped with the cleaning solution.

4. Dispose of the paper towels as biohazard waste.

Caution: Biohazard! Dispose of the paper towels as


biohazard waste.

Backflushing the SIP


Introduction This topic describes how to run the backflush cycle to remove clogs
at the base of the SIP.

About the The backflush cycle forces fluid out of the flow cell and out the SIP
backflush cycle to remove bubbles in the flow cell and/or clogs in the SIP. Perform
a backflush if you notice the event rate slowing or stopping and
you suspect a clog.
Chapter 6: Maintenance 107

You can use a backflush cycle to check for clogs or faulty tubing.
During a backflush, a few drops of fluid are dispensed from the
SIP, followed by a steady stream of fluid, followed by more drops.
If you do not see a steady stream or the stream is exiting the SIP at
an angle, the SIP may be clogged. See Performing a SIP clean
(page 108) and Unclogging the SIP (page 121). If no fluid is
dispensed, there may be a problem with the fluid bottle filters or
the peristaltic tubing. See Replacing the fluid bottle filters
(page 113) and Replacing the peristaltic pump tubing (page 116).

Backflushing when To perform a backflush when running manually:


running manually 1. Place an empty tube on the SIP.

2. Select Instrument > Run Backflush cycle.

You can also click Backflush from the Acquire tab.

3. Click Backflush in the dialog prompting you to load an empty


tube.

4. When the backflush is complete, discard the tube in the same


way as you would any biohazardous sample to ensure no
possible safety risk.

Backflushing when To perform a backflush using the Loader:


using a Loader 1. Ensure a tube containing 2 mL of DI water is located in the
square location ( ).

2. Select Instrument > Run Backflush cycle.

You can also click Backflush from the Acquire tab.

More information • Unclogging the SIP (page 121)


• Replacing the peristaltic pump tubing (page 116)
108 BD FACSVia System Instructions for Use

Performing a SIP clean


Introduction This topic describes how to clean the SIP with BD FACSClean.

About SIP cleans The SIP clean runs BD FACSClean through the SIP for
approximately 5 minutes followed by water for approximately
5 minutes. Regular SIP cleans are vital for keeping your fluidics
system clear and free of clogs.

When to run a SIP A SIP clean is performed automatically at the end of each worklist
clean if the Run SIP Clean After Worklist checkbox is selected on the
Acquire tab. However, we recommend always running a SIP clean
at the end of each worklist. You can also run a SIP clean as often as
you like to prevent SIP clogs.

Caution: If you leave the instrument idle for 15 minutes


or longer when running samples, run a SIP clean before
resuming operation to clear the SIP and prevent clogs.

Required materials • 2 mL of BD FACSClean


• 2 mL of fresh DI water

Performing a SIP To perform a SIP clean when running manually:


clean when running 1. Click SIP Clean on the Acquire tab.
manually
A dialog prompts you to load a tube containing 2 mL of
BD FACSClean.

2. Load the tube of BD FACSClean and click Clean.

When step 1 is complete, a dialog prompts you to load a tube


containing 2 mL of water.

3. Load the tube of water and click Clean.


Chapter 6: Maintenance 109

Performing a SIP To perform a SIP clean using the Loader:


clean when using a 1. Click SIP Clean on the Acquire tab.
Loader
A dialog opens prompting you to load tubes of BD FACSClean
and water.

2. Ensure the following tubes are in the designated locations on


the Loader. If necessary, click Eject Rack and insert the tubes,
then click Load Rack.

• 2 mL of BD FACSClean in the triangle location ( )


• 2 mL of DI water in the circle location ( )
• Also ensure the square ( ) location has a tube containing
2 mL of DI water, as the SIP is left in this tube after a SIP
clean.
3. Click SIP Clean.

More information • Unclogging the SIP (page 121)


110 BD FACSVia System Instructions for Use

Cleaning the fluidics


Introduction This topic describes how to clean the fluidics lines using the Clean
Fluidics cycle.

About cleaning the The fluidics cleaning cycle is automatically run when you shut
fluidics down the instrument. You can also run it at any time, if necessary.
During the fluidics cleaning cycle, BD FACSClean is run through
the fluid lines, followed by sheath. A second cycle runs detergent
solution through the fluid lines, followed by sheath.

The fluidics cleaning takes about 13 minutes.

Required materials • 2 mL of DI water

Cleaning the To clean the fluidics when running manually:


fluidics when 1. Place a tube containing 2 mL of DI water on the SIP.
running manually
2. Select Instrument > Run Clean Fluidics.

Cleaning the To clean the fluidics when using a Loader:


fluidics when using 1. Ensure that a tube containing 2 mL of DI water is located in
a Loader the square location ( )

2. Select Instrument > Run Clean Fluidics.

Running an extended flow cell clean


Introduction This topic describes how to run an extended flow cell clean cycle.

About an extended An extended flow cell clean cycle provides a way to thoroughly
flow cell clean clean the flow cell. Run an extended flow cell clean cycle if you
notice excessive debris or high CVs during instrument QC. During
Chapter 6: Maintenance 111

extended flow cell cleaning, the flow cell fills completely with
cleaning solution from a sample tube on the SIP. The cycle
automatically shuts down the cytometer, allowing the flow cell to
soak with the cleaning solution.

Required materials • 2 mL of BD Extended Flow Cell Clean Solution

Procedure To run an extended flow cell clean:


1. Place a tube with at least 500 µL of Extended Flow Cell Clean
Solution on the SIP.

Caution! Never run an extended flow cell clean


cycle without a tube containing at least 500 µL of
fluid.
2. Select Instrument > Extended Flow Cell Clean.

A dialog opens prompting you to install a tube of Flow Cell


Cleaner on the SIP if running manually, or load a rack with the
solution in position A01 if using a Loader.

3. Load the tube of Extended Flow Cell Clean Solution and click
Proceed.

4. After the cytometer is shut down, leave it off for at least


2 hours (or overnight, for a more thorough cleaning).

5. Restart the cytometer.

To thoroughly rinse the flow cell, the cytometer performs a full


fluidics cleaning cycle at startup and the software displays the
message Extra startup time needed due to cleaning or
improper shutdown.

Note: This message also appears after a power outage if the


instrument was forced to shut down.

6. Discard the tube once startup is complete.


112 BD FACSVia System Instructions for Use

Cleaning the fluid bottles


Introduction This topic describes how to clean the sheath, waste, detergent
solution, and FACSClean bottles.

About cleaning the Clean the bottles every month to ensure that residue and
bottles contaminants do not build up inside the bottles. Do not allow the
bottle filters to dry out while you clean the bottles.

Required materials • 10% bleach solution


• DI water

Procedure To clean the fluid bottles:


1. Disconnect and empty all the bottles.

2. Rinse the bottles with DI water.

3. Rinse the bottles with a 10% bleach solution.

4. Thoroughly rinse the bottles with DI water 2–3 times to


remove the bleach residue.

5. Refill each bottle with the appropriate fluid. See Filling the
fluid bottles (page 44).

6. Replace the caps on the fluid bottles.

7. Snap the color-coded tubing back into the fittings by pushing


firmly until you hear a click.
Chapter 6: Maintenance 113

Replacing the fluid bottle filters


Introduction This topic describes how to replace the fluid bottle filters.

About fluid bottle The sheath, BD FACSClean, and detergent bottles each contain a
filters disk filter. We recommend replacing these filters every 2 months.

Caution: Biohazard! Contact with biological specimens


and materials can transmit a potentially fatal disease.
Wear suitable protective clothing, eyewear, and gloves.

Required materials • Three fluid filters (one for each bottle)

Procedure To replace the fluidic bottle filters:


1. Disconnect the quick-connect lines from the top of each bottle.

2. Carefully remove the lid from each bottle.

3. Disconnect the filter Luer connector at the end of the fluidic


tubing. Discard the filter as you would a biological sample.

2
114 BD FACSVia System Instructions for Use

The following table describes the components of the bottle cap


assembly.

No. Component Description


1 Fluid sensing line Detects fluid in the bottle.

2 Disk filter Filters the fluid from the bottle.

4. Replace the filter with the same filter type.

5. Reassemble the bottles and reconnect the quick-connect lines.

Replacing the in-line sheath filter


Introduction This topic describes how to replace the in-line sheath filter.

When to replace We recommend replacing the in-line sheath filter every 2 months.
the in-line sheath
filter If you notice a yellow discoloration, fluid leaking, or if the filter is
less than 50% full, change the filter immediately.

Required materials • In-line sheath filter

Before you begin Write today’s date on the new in-line sheath filter to help you keep
track of unscheduled filter replacements.

Procedure To replace the in-line sheath filter:


1. Turn off the cytometer.

The Clean Fluidics cycle runs for approximately 13 minutes,


then the cytometer powers off automatically.

2. Lift the cytometer lid and remove the plastic storage bin.
Chapter 6: Maintenance 115

3. Each time you change the in-line sheath filter, visually inspect
all tubing and connectors for fluid leaks.

Look for liquid, dried residue, or discoloration of the metal


surfaces anywhere near the tubing. If you notice any evidence
of a leak, contact BD Biosciences Technical Support.

Caution: Biohazard! Any evidence of fluid coming


from, or near, a red or clear line should be
considered a biological hazard.

Caution: Biohazard! Wear suitable protective


clothing, eyewear, and gloves. Dispose of waste using
proper precautions and in accordance with local
regulations.
4. Twist the Luer locks on both ends of the in-line sheath filter to
disconnect the locks. Do not pull on the tubing.

5. Discard the filter.

Although sample material does not pass through this filter, we


recommend discarding it in the same way as any biohazardous
sample to ensure no possible safety risk.

6. Install a new in-line sheath filter by reconnecting the Luer


fittings.

This filter has a male and female end to ensure that it can only
be installed in the correct orientation.
116 BD FACSVia System Instructions for Use

7. Replace the plastic storage bin and close the cytometer lid.

8. Place a sample tube with DI water on the SIP, or if using a


Loader, make sure there is a tube with 2 mL of water in the
square location ( ).

9. Turn on the cytometer.

Note: Upon startup you may see an error message indicating that
a fluidics system error was detected. This error is normal after
replacing the in-line sheath filter. See Hardware fault errors
(page 141) for information.

Replacing the peristaltic pump tubing


Introduction This topic describes how to replace the tubing for the peristaltic
pumps. The cytometer includes two peristaltic pumps—a sheath
pump and a waste pump.

About this Replace the pump tubing every 2 months. We recommend


procedure replacing both pieces of tubing at the same time.

Caution: Moving parts! Turn off the cytometer before


changing the tubing.

Tubing comes in contact with biological samples and therefore


should be considered hazardous.

Caution: Biohazard! Contact with biological specimens


and materials can transmit a potentially fatal disease.
Wear suitable protective clothing, eyewear, and gloves.

Required materials • Peristaltic pump tubing


Chapter 6: Maintenance 117

Procedure To replace the pump tubing:


1. Turn off the cytometer.

The Clean Fluidics cycle runs for approximately 13 minutes,


then the cytometer powers off automatically.

2. Lift the cytometer lid.

3. Squeeze the grip marks on both sides of the pump retainer clip
to remove the clip.

4. Carefully pull the Luer connectors outward, sliding the fittings


off the pump head.
118 BD FACSVia System Instructions for Use

5. Disconnect the tubing by unscrewing the plastic Luer


connectors (a total of four connectors—two for each pump).

Blue tubing is connected to the sheath pump and red tubing to


the waste pump.

6. Remove the pump tubing from the pump head and discard it
as you would a biological sample according to standard
laboratory protocols and regulations.

Sample passes through this pump tubing. Consider it


biologically hazardous.

7. Install new peristaltic pump tubing by sliding the Luer fittings


on the pump head and snapping the fitting in place.

8. Replace the pump retainer clip.

9. Reconnect the tubing to the Luer connectors.

Caution! Ensure that the Luer fittings are connected


to the correct tubing elements. Also ensure that when
you tighten the fittings, the tubing does not twist or
kink. If it does twist, unscrew the Luer fitting, turn it
counter-clockwise, then retighten it.
10. Gently close the cytometer lid.

11. Place a sample tube with DI water on the SIP, or if using a


Loader, make sure there is a tube with 2 mL of water in the
square location ( ).

12. Turn on the cytometer.


Chapter 6: Maintenance 119

Note: Upon startup you may see an error message indicating that
a fluidics system error was detected. This error is normal after
replacing the peristaltic pump tubing. See Hardware fault errors
(page 141) for information.

Purging the fluid sensor lines


Introduction This topic describes how to purge the fluid sensing lines. See
Replacing the fluid bottle filters (page 113) for information on the
fluid sensing lines.

About this Perform this procedure if the traffic light message indicates that the
procedure sheath is empty or the waste is full, when in fact all fluid levels are
as they should be. Fluid in the sensing lines can lead to erroneous
fluid level messages.

Before you begin Start with the instrument turned off. Ensure the sheath bottle is full
and the waste bottle is empty, except for bleach. Place the sheath
bottle on the benchtop where you can monitor the fluid level.

Procedure 1. Lift the cytometer lid and remove the plastic storage bin.

2. Locate the round, finger-size access hole near the in-line sheath
filter.
120 BD FACSVia System Instructions for Use

3. Place your finger over the pin hole inside the access hole.

4. With your finger sealing the pin hole, turn on the cytometer.

5. Keep your finger over the hole for 30 seconds. You should see
continuous bubbling in the sheath bottle.

6. After 30 seconds, remove your finger.

7. Replace the storage bin and close the lid to allow the
cytometer to complete the normal fluidics startup.
Chapter 6: Maintenance 121

Unclogging the SIP


Introduction This topic describes how to use a syringe to unclog and rinse the
SIP.

About this Perform the syringe SIP unclog if the SIP is clogged and performing
procedure backflushes and SIP cleans have not fixed the problem.

Required materials • Two 3-mL syringe tools (assembled)


• BD FACSClean
• DI water

Before you begin Before using the syringe to unclog the SIP, try unclogging the SIP
by performing several backflushes followed by several SIP cleans.

Assembling the Assemble two syringe tools as follows:


syringes
1. Connect the female Luer connector, tubing, and quick-connect
coupling.

2. Connect the tubing assembly to a 3-mL syringe, as shown.

Unclogging the SIP To unclog the SIP:


1. Turn off the cytometer.

The Clean Fluidics cycle runs for approximately 13 minutes,


then the cytometer powers off automatically.

2. Lift the cytometer lid.


122 BD FACSVia System Instructions for Use

3. Disconnect the three flow cell fluid lines (blue sheath, red
waste, clear purge) from the chassis by turning each connector
approximately 1/8 turn counter-clockwise.

The waste and purge lines come in contact with biological


samples and therefore should be considered hazardous. Place
paper towels under the tubing to catch any drops of fluid.

Caution! Contact with biological specimens and


materials can transmit a potentially fatal disease.
Wear suitable protective clothing, eyewear, and
gloves.
4. Connect the blue (sheath) and red (waste) lines to each other
by aligning the connectors together and twisting slightly.

5. Fill the first syringe with BD FACSClean.

6. Ensure an empty tube is installed on the SIP.


Chapter 6: Maintenance 123

7. Connect the syringe to the clear (purge) line by aligning the


connectors and twisting slightly.

8. Slowly depress the plunger on the syringe, pushing the cleaning


solution into the flow cell and out the SIP.

9. Slowly pull the plunger to pull the cleaning solution back into
the syringe.

10. Repeat the push/pull cycle a few more times to ensure the clog
is cleared. Finish by pushing the BD FACSClean into the tube.

Rinsing the SIP To rinse the SIP:


1. Fill the second syringe with DI water.

2. Install an empty tube on the SIP.

Note: If performing this procedure with a Loader, ensure that


the tube in the square ( ) location, in which the SIP is parked,
does not overflow.

3. Connect the syringe to the clear (purge) line.

4. Slowly depress the plunger on the syringe, pushing water into


the flow cell and out the SIP.
124 BD FACSVia System Instructions for Use

5. Slowly pull the plunger to pull the water back into the syringe.

6. Repeat the push/pull cycle a few more times to ensure the SIP
is thoroughly rinsed. Finish by pushing the water into the tube.

7. Disconnect the syringe from the clear (purge) line.

8. Disconnect the blue (sheath) and red (waste) lines from each
other.

9. Reconnect the three lines to the connectors in the chassis by


turning each connector approximately 1/8 turn clockwise until
they click into place.

Aligning the Loader after a collision


Introduction This topic describes how to perform a manual alignment of the
rack to the SIP if the Loader arm collides with an object in its path.

About alignment The Loader performs an alignment to verify that the tube rack is
aligned to the SIP every time the flow cytometer is powered up or if
the Loader arm collides into an object. A manual alignment can be
performed using the software at any time.

If there is an obstruction in the path of the Loader, the software


displays a red traffic light and opens a dialog indicating that a
collision has occurred.
Chapter 6: Maintenance 125

Procedure To perform an alignment:


1. Remove any objects from the Loader mat.

2. Do one of the following:

• If a collision has occurred, click Align in the Collision


Detected dialog.
• If a collision did not occur, select Instrument > Align
Loader.
If a second collision occurs, the software automatically performs a
second alignment. If the second alignment fails, contact
BD Biosciences Technical Support.

Samples left in the tube rack can be recovered by turning off the
cytometer and gently pushing down on the white cylindrical motor
housing.
126 BD FACSVia System Instructions for Use

Restarting the system after storage


Introduction This topic explains how to prepare the BD FACSVia cytometer for
use after it has been stored for a period of time.

Procedure 1. Replace all fluid bottle filters—sheath, BD FACSClean, and


detergent. See Replacing the fluid bottle filters (page 113).

2. Replace the in-line sheath filter. See Replacing the in-line


sheath filter (page 114).

3. Fill the fluid bottles with fresh fluid and ensure the waste
bottle is empty except for 200 mL of bleach. See Filling the
fluid bottles (page 44).

4. Turn on the cytometer. See Starting up the system (page 49).


Allow the startup fluid cycle to complete. It takes about
15 minutes.

5. Turn off the cytometer. See Shutting down the system


(page 52). Allow the shutdown fluid cycle to complete. It takes
about 13 minutes.

6. Turn on and off the cytometer two more times, allowing the
fluid cycles to complete.
7
Administrative tasks
Note: Some administrative tasks, like managing user accounts, can be performed only
by administrators; while other tasks, like managing files, can be performed by any
operator.

This chapter covers the following topics:

• Managing user accounts (page 128)


• Managing files (page 131)
• Selecting the report language (page 135)
• Configuring BD FACSLink™ software (page 135)
128 BD FACSVia System Instructions for Use

Managing user accounts


Introduction This topic describes how the administrator can add and delete user
accounts, and reset a user’s password.

The Admin menu, used to add and delete users, appears only when
the administrator is logged on.

Adding a user Only the administrator can add new user accounts.
account
To add a new user:
1. Sign in as the administrator.

2. Select Admin > Users.

3. In the Users dialog, click Add New User.

4. Type a user name and password for the user in the


corresponding fields.

5. Type any notes you want to add in the Notes field.

This information is only visible in the Users dialog and the


user Usage log. See Monitoring user activity (page 129).

6. Click Save.

Users are organized in alphabetical order once you click Save.


Chapter 7: Administrative tasks 129

Deleting a user Only the administrator can delete a user account. The
account administrator account cannot be deleted.

To delete a user account:


1. Select Admin > Users.

2. Click Delete next to the user account you want to remove.

3. Click Save.

Resetting a Only the administrator can change a user password. This may be
password necessary if a user forgets their password.

To change a user password:


1. Select Admin > Users.

2. Delete the text in the Password field and type a new password.

3. Click Save.

Monitoring user Each time a user signs into or out of the software, an entry is
activity created in the userUsage log. You can view this log at any time to
see who has used the software.

To view the userUsage log:


1. Navigate to C:\Cytometer Support Files.
130 BD FACSVia System Instructions for Use

2. Double-click userUsage.csv to open it.

If BD FACSVia clinical software is open, a message appears


that the usage log file is in use and locked for editing. Click
Read Only to view the file.

This log is a .csv file which contains the following information:

• Date and time of sign in/sign out


• User name
• Cytometer serial number
• Activity details (sign in or sign out)
• Notes entered when the user was added to the system

More information • Opening BD FACSVia clinical software (page 51)


Chapter 7: Administrative tasks 131

Managing files
Introduction This topic describes the files generated by BD FACSVia clinical
software. It also describes how to export FCS data files, save CSV
results files, and use the sample search feature to search for data
files.

About BD FACSVia The BD FACSVia system generates the following files. For
files information on the default save locations, see Save Location
preferences (page 35).

File Description
FCS FCS 3.1 files are not saved by default, but can be
exported at any time following acquisition. See
Exporting FCS data files (page 132) for information.

Workspace Workspace files contain all the information entered at


the Acquire tab of the workspace, including sample
information, BD Trucount bead information, and
laboratory information, as well as the test data.

Lab reports A laboratory report is automatically saved for each


sample. The lab reports are named
ID_test_yyyymmdd_hhmmss.pdf.

Physician and Physician and summary reports are saved only if you
summary select to save them in the Save Locations preferences.
reports A physician report is created for each sample. A single
summary report includes a list of all samples in the
worklist.

Results CSV CSV files are saved only if you select to save them in
the Save Locations preferences. A single CSV file is
saved for each sample.

QC reports A QC report is saved for each instrument QC test.

HLA-B27 A report is saved for each HLA-B27 setup performed.


Setup reports

Note: Levey-Jennings reports can be printed, but they cannot be


saved or exported.
132 BD FACSVia System Instructions for Use

Searching for files The software allows you to search for any sample file. It scans all
workspace files in the selected directory for the sample ID that you
enter. Any user can use the search feature to search for files

To search for a file:


1. Select File > Sample Search.

2. Click Choose Folder and navigate to the folder where the file is
located. Select the folder, then click Select Folder.

3. Use the following options to select the search criteria:

• Enter the sample ID or any part of it.


• Enter the date range when the sample was acquired. Use
the format yyyy-mm-dd.
4. Click Search.

The path to the workspace containing the sample ID or date


range you entered is displayed.

5. Use this information to access or open the workspace file by


selecting File > Open BD FACSVia workspace.

Exporting FCS data You can export the data from a worklist to individual FCS 3.1
files files.

To export FCS data files:


1. Select File > Export All Samples as FCS.

A dialog opens showing the folder where all sample data will
be exported.

2. Click OK.
Chapter 7: Administrative tasks 133

The files are exported to C:\Users\Public\Public Documents\BD


Accuri Files\FCS Files\yyymmdd_hhmmss. The dated folder
contains an individual FCS file for each sample in the worklist.

Results CSV files You can save a CSV results file for individual samples. The CSV
file contains the sample information, BD Trucount bead
information, and laboratory information, as well as the results.

To save results CSV files:


1. Select File > Preferences.

2. Select Results CSV File under Test Results.

The default file location is displayed. If you wish to change the


default location, click Browse and navigate to a new location.

3. Click Save.

Removing QC You can remove old QC runs that appear in the history file. See
report files from Viewing previous QC results (page 70).
the history list
1. Navigate to C:\Cytometer Support
Files\InstrumentPerformance.

Each QC results file is listed as InstrumentPerformanceyyyy-


mm-dd-hh_mm.ipr.

2. Delete the QC results files you no longer need.


134 BD FACSVia System Instructions for Use

The QC results for the dates you deleted will no longer appear
in the history file list. However, the results will still appear in
the Levey-Jennings plots.

Removing bead lots You can remove old CS&T bead lots so that they no longer appear
from the CS&T in the bead lot menu on the QC workspace.
bead lot menu
1. Navigate to C:\Cytometer Support
Files\InstrumentPerformance\BeadLots.

Bead lot files have the extension .bls.

2. Delete the bead lot files you no longer need.

The deleted bead lots will no longer appear in the BD CS&T


Bead Lot menu on the QC workspace. If you need to replace a
deleted bead lot, do not copy the file into this folder. You must
reinstall bead lots using the software. See Install a new bead lot
(page 60).

More information • Software preferences (page 35)


• Running instrument QC (page 58)
• Viewing previous QC results (page 70)
Chapter 7: Administrative tasks 135

Selecting the report language


Introduction Administrators can select the language for QC and Lab reports.

Procedure To select the language for reports:


1. Select Admin > Select report language.

2. Select a language from the menu and click OK.

More information • Save Location preferences (page 35)


• Viewing QC results (page 67)
• Reviewing reports (page 91)

Configuring BD FACSLink™ software


Introduction This topic describes how to configure BD FACSLink software so
you can use it to transfer results files to the laboratory information
system (LIS).

About BD FACSLink The BD FACSLink LIS Interface Solution is a software application


software that streams BD FACSVia software result files to the LIS.

Configuring To configure BD FACSLink software:


BD FACSLink 1. Select Admin > BD FACSLink Settings.
software
136 BD FACSVia System Instructions for Use

The BD FACSLink Settings dialog is displayed.

2. Select Use BD FACSLink.

3. Enter the following information:

Field Description
IP Address IP address to the BD FACSLink server

Port Number Server port accessed by BD FACSVia software

Username BD FACSLink username

Password BD FACSLink password

4. Click Check Connection.

The software checks for a connection. A dialog opens


indicating that the connection was successful.

5. Click Save.

More information • BD FACSLink software troubleshooting (page 150)


8
Troubleshooting
This chapter covers the following topics:

• Troubleshooting overview (page 138)


• Hardware troubleshooting (page 138)
• Software troubleshooting (page 143)
• Acquisition troubleshooting (page 145)
• QC troubleshooting (page 147)
• BD FACSLink software troubleshooting (page 150)
138 BD FACSVia System Instructions for Use

Troubleshooting overview
Introduction This topic describes troubleshooting for the BD FACSVia system.

The Troubleshooting chapter lists problems you may encounter


during normal operation. It includes:

• Hardware troubleshooting (page 138)


• Software troubleshooting (page 143)
• Acquisition troubleshooting (page 145)
• QC troubleshooting (page 147)
• BD FACSLink software troubleshooting (page 150)

Additional help You can find additional troubleshooting information specific to the
test you are performing in the corresponding application guide.

If, after reading through the possible problems and recommended


solutions, you still have questions or are experiencing problems,
contact BD Technical Support. See Technical support (page 13) for
information.

Hardware troubleshooting
Introduction This topic describes how to troubleshoot hardware problems with
the cytometer or Loader.

Cytometer and/or
computer does not Possible causes Recommended solutions
power on
Power supply not Make sure the power supplies and cords are
plugged in plugged into an appropriate outlet.

Power outlet Check the outlet to make sure it is functioning


malfunction properly.
Chapter 8: Troubleshooting 139

Power and event Power and event indicator lights flash simultaneously.
indicator lights
flash on startup Possible causes Recommended solutions
Waste tank full Turn off the power to the cytometer. Empty the
waste bottle, then restart the cytometer.

Power and event indicator lights flash alternately.

Possible causes Recommended solutions


Loader failed to Turn off the power to the cytometer. Check for
align properly obstructions, then restart the cytometer.

Message “Extra
startup time Possible causes Recommended solutions
needed due to
Extended flow cell Allow the extended startup to run. It will take
cleaning or clean cycle was run. approximately 25 minutes.
improper
shutdown” Fluidics error
occurred during
shutdown.
Instrument forcibly
shut down, for
example power
outage.

USB port not active


or lost connection Possible causes Recommended solutions
Using a USB port on Do not use a USB port on the same hub as the
the same hub as the cytometer. For example, use USB ports on the
cytometer front of the computer for flash drives.

If the USB port is not on the same hub as the


cytometer, unplug the drive, wait 5 seconds,
then plug it back in. If that doesn’t work,
restart the computer.
140 BD FACSVia System Instructions for Use

Loader collision
Possible causes Recommended solutions
Collision message Time-out occurred because the Loader did not
appears but no reach its designation in the time permitted.
collision occurred Select Instrument > Align Loader. See Aligning
the Loader after a collision (page 124)

Loader software
does not display Possible causes Recommended solutions
the Loader tube
Loader cable Shut down the cytometer and software before
rack map disconnected reconnecting the Loader cable to the back of
the cytometer. Restart the cytometer and open
the software.

Fluid leak under


storage bin Possible causes Recommended solutions
In-line sheath filter Check the Luer locks on both ends of the filter
leaking to ensure they are tight. If the filter appears
yellow or is less than 50% filled with fluid,
change it immediately. The filter should be
submerged in fluid.

Peristaltic pump Check the peristaltic pump tubing on both


tubing not properly pumps to ensure it is properly connected to the
installed Luer connectors.

Traffic light
displays message Possible causes Recommended solutions
that waste is full or
Fluid bottle sensing Purge the fluid bottle sensing lines. See Purging
sheath is empty lines have fluid in the fluid sensor lines (page 119).
when they are not them
Chapter 8: Troubleshooting 141

Message “Your
print job failed” Possible causes Recommended solutions
Printer not Ensure a printer is connected, either locally or
connected or not through a network, and turned on.
turned on

Network down If the printer is connected to a network, ensure


that the network is up and running.

Hardware fault If a hardware error occurs, click Close this window, then follow
errors the steps listed. A lab report will not be generated for the sample.

Message Recommended solutions


The cytometer 1. Check the fluid levels in sheath, detergent
stopped because a solution, and BD FACSClean bottles.
Fluidic Stability Error 2. Check the retainer clips on the fluid pumps
occurred. to ensure they are properly installed.
3. Perform a backflush, followed by a SIP
clean.
4. Check the system’s performance by
running instrument QC.
5. If you are running a sample, check the
sample tube to ensure adequate sample,
then rerun the sample.
6. If the problem persists, contact
BD Technical Support.

The cytometer 1. Check the system’s performance by


stopped because a running instrument QC.
Red/Blue Laser Error 2. Rerun the sample.
occurred.
3. If the problem persists, contact
BD Technical Support.

The cytometer 1. Rerun the sample.


stopped because a 2. If the problem persists, contact
Signal Processing BD Technical Support.
Error occurred.
142 BD FACSVia System Instructions for Use

Message Recommended solutions


The cytometer Contact BD Technical Support.
stopped because an
Electronic System
Error occurred.

A Fluidics System If the in-line sheath filter or peristaltic pump


Error was detected. tubing was changed, this message is normal.
1. Perform two to three backflush cycles.
2. Turn off the cytometer, then restart it.
3. If the error appears again, restart the
cytometer a second time.
4. If the problem persists after two shutdown
and startup cycles, contact BD Technical
Support.

If the in-line sheath filter was not just changed:


1. Check the fluid bottles—fill the sheath and
cleaning bottles and/or empty the waste.
2. Check the BD FACSClean (circle) and DI
water (triangle) tubes on the Loader tray, if
using a Loader, to ensure they contain
fluid.
3. If running samples, ensure there is fluid in
the sample tube.
4. Check the connections to the fluid bottles,
filter, and pumps.
5. Turn off the cytometer, then restart it.
6. If the problem persists, contact
BD Technical Support.

The cytometer 1. Ensure that the USB cable is connected


stopped because a between the cytometer and the computer.
USB Connection 2. If necessary, restart the software.
Error occurred.
3. If the problem persists, contact
BD Technical Support.
Chapter 8: Troubleshooting 143

Software troubleshooting
Introduction This topic describes general problems related to the software.

Assay does not


appear in Test Possible causes Recommended solutions
menu
Assay file missing Check Program Files\BD Accuri\BD FACSVia
from testDefinitions Clinical Software\clinical\testDefinitions folder.
folder or file is If assay file does not appear, reinstall the assay.
corrupt If the assay file appears, delete and reinstall it.
Restart the software.

Software hangs at
startup and will not Possible causes Recommended solutions
launch
Software launching Software requires more time to launch. Give
slowly the application time to launch.

USB flash drive Do not use a USB port on the same hub as the
plugged into same cytometer. For example, use USB ports on the
hub as cytometer, front of the computer for external flash drives.
disrupting
 Disconnect flash drive.
communication
 Disconnect the USB cable between the
cytometer and computer, then reconnect it.

Javaw.exe process Use the task manager to end the javaw.exe


interfering process.
1. Press Ctrl + Alt + Delete.
2. Click Start Task Manager.
3. Click the Processes tab.
4. Select javaw.exe and click End Process.
If the process still won’t quit, unplug the USB
cable from the cytometer, then plug it back in.
144 BD FACSVia System Instructions for Use

Software not
responding Possible causes Recommended solutions
USB flash drive Do not use a USB port on the same hub as the
plugged into same cytometer. For example, use USB ports on the
hub as cytometer, front of the computer for external flash drives.
disrupting
 Disconnect the flash drive.
communication
 Disconnect either end of the USB cable
between the cytometer and computer, then
reconnect it.

Javaw.exe process Use the task manager to end the javaw.exe


interfering process.
1. Press Ctrl + Alt + Delete.
2. Click Start Task Manager.
3. Click the Processes tab.
4. Select javaw.exe and click End Process.
If the process still won’t quit, unplug the USB
cable from the cytometer, then plug it back in.

USB cable Ensure the USB cable between the cytometer


disconnected and the computer workstation is connected.

The traffic light


does not turn green Possible causes Recommended solutions
USB cable not 1. Make sure the USB cable is properly
properly connecting connected between the cytometer and
the cytometer to the computer. It may take several seconds for
computer the port to recognize the cytometer.
2. If necessary, restart the computer.

Switch the USB cable to a different port on the


computer.
Chapter 8: Troubleshooting 145

Software appears
to shut down but is Possible causes Recommended solutions
still running in the
Javaw.exe process Use the task manager to end the javaw.exe
background interfering process.
1. Press Ctrl + Alt + Delete.
2. Click Start Task Manager.
3. Click the Processes tab.
4. Select javaw.exe and click End Process.
If the process still won’t quit, unplug the USB
cable from the cytometer, then plug it back in.

Acquisition troubleshooting
Introduction This topic describes how to troubleshoot problems you encounter
during acquisition, including the data displayed in the plots.

See the appropriate application guide for specific assay


troubleshooting information.

Data does not look


as expected Possible causes Recommended solutions
Sample needs to be Abort and restart run. Or, rerun sample at
restarted completion of run.

Fluidics dirty or 1. Ensure the sheath fluid is filtered through a


clogged 0.2-µm filter.
2. Perform a backflush.
3. Perform a SIP clean.

Air bubbles in flow 1. Perform a backflush.


cell or in-line sheath 2. Perform a SIP clean.
filter
146 BD FACSVia System Instructions for Use

Red exclamation
point appears next Possible causes Recommended solutions
to the sample
Hardware fault If a hardware fault error occurs during
number in the error acquisition, sample data is not available for
worklist analysis and a lab report for the sample does
not get generated. Rerun the sample. See
Hardware fault errors (page 141) for a list of
errors.

Event rate drops


during acquisition Possible causes Recommended solutions
Cells settled in Pause acquisition and mix the tube. If using a
bottom of tube Loader, eject the rack and manually mix the
tubes.

Fluidics dirty or 1. Perform a backflush.


clogged 2. Perform a SIP clean.
3. If the problem persists, perform an
extended flow cell clean cycle.

Pumps are running


normally, but data Possible causes Recommended solutions
is not being
Sheath too low and/ Check the levels in the sheath and waste
acquired or waste too high bottles.

Fluidics lines Check all fluidics lines, at bottles, harness, and


crimped peristaltic pumps, to see if any are crimped.

SIP clogged 1. Perform a backflush.


2. Perform a SIP clean.
3. If the problem persists, contact
BD Technical Support.

Peristaltic pump Make sure peristaltic pump tubing and retainer


tubing not attached clip are properly attached.
properly
Chapter 8: Troubleshooting 147

Pumps are running


continually Possible causes Recommended solutions
Air in the in-line  If the filter is less than 50% filled with
sheath filter fluid, replace it.
 If the filter contains an air pocket, perform
a backflush, followed by a SIP clean.

Fluidics lines 1. Perform a backflush.


clogged 2. Perform a SIP clean.

Peristaltic pump Replace peristaltic pump tubing.


tubing damaged

QC troubleshooting
Introduction This topic describes how to troubleshoot problems with
instrument QC.

No beads were
detected Possible causes Recommended solutions
No beads in sample Make sure you are running the correct sample
tube.

Beads not properly  Vortex bead vial before preparing bead


mixed suspension.
 Vortex bead suspension before running
beads.
148 BD FACSVia System Instructions for Use

QC result failed
Possible causes Recommended solutions
Regions and/or Adjust regions and markers, as necessary. See
markers not set Adjusting the bead regions and markers
correctly (page 62).

Expired beads Check bead expiration date. If necessary, rerun


QC with new beads.

Old bead Once prepared, beads are stable for 8 hours if


suspension stored at 2–8°C and protected from light. After
this period, prepare a fresh bead suspension.

High CVs caused by 1. Ensure the sheath fluid is filtered through a


bubbles/debris 0.2-µm filter.
2. Perform a backflush.
3. Perform a SIP clean.

QC messages
Message Recommended solutions
Event count for Mid  Beads settled in bottom of tube. Resuspend
+ Bright too low the beads and rerun the sample.
 Ensure that the region is encompassing the
mid + bright bead population in the FSC vs
SSC plot. Adjust the region, if necessary.

Percentage of events  Beads settled in bottom of tube. Resuspend


for Mid + Bright too the beads and rerun the sample.
low  Ensure that the region is encompassing the
mid + bright bead population in the FSC vs
SSC plot. Adjust the region, if necessary.
 Beads are no longer stable. Prepare a fresh
bead solution.
Chapter 8: Troubleshooting 149

Message Recommended solutions


Percentage of events Rerun the beads. If the message appears again,
in FSC/SSC/FL1/FL2/ prepare a new bead suspension. Do not adjust
FL3/FL4 Noise too the noise gates. If the problem persists, contact
low BD Technical Support.

Event count for FL1/ Make sure the bead peak in the corresponding
FL2/FL3/FL4 Bright plot is located within the markers. Adjust the
too low marker, if necessary. If the message still
appears, prepare a new bead suspension.

Percentage of events Make sure the bead peak in the corresponding


in FL1/FL2/FL3/FL4 plot is located within the markers. Adjust the
Bright too low marker, if necessary. If the message still
appears, prepare a new bead suspension.

Bright bead median As seen in the Levey-Jennings plots.


and/or %rCV drift
over time
Possible causes Recommended solutions
Peristaltic pump Change the peristaltic pump tubing.
tubing worn

Additional For more information on troubleshooting QC, see the


information troubleshooting section of the BD CS&T Beads instructions for
use.
150 BD FACSVia System Instructions for Use

BD FACSLink software troubleshooting


Introduction This topic describes how to troubleshoot BD FACSLink software
problems.

Message: “Failed to
connect to BD Possible causes Recommended solutions
FACSLink” when
BD FACSLink not Ensure that Use BD FACSLink is selected in
you click Check properly configured BD FACSLink Settings dialog. See Configuring
Connection BD FACSLink software (page 135).

Incorrect IP address Ensure correct IP address and port to


or port BD FACSLink server was entered in
BD FACSLink Settings dialog.

Cable disconnected Ensure network cable is securely connected to


BD FACSVia computer.

Message: “There is
a problem Possible causes Recommended solutions
communicating
Cable disconnected Ensure network cable is securely connected to
with BD FACSLink” BD FACSVia computer.

Network down Check to see that the network is up.

Message: “No Test


Orders found for ID Possible causes Recommended solutions
XXXX” when filling
No pending test for Enter test information manually. The ID is case-
out the worklist ID entered sensitive.
9
Technical specifications
This chapter covers the following topics:

• System specifications (page 152)


152 BD FACSVia System Instructions for Use

System specifications
Introduction This topic describes the system specifications.

Cytometer
specifications Item Specification
Dimensions Height: 27.9 cm (11 in.)
Width: 37.3 cm (14.7 in.)
Depth: 41.9 cm (16.5 in.)
With fluid bottles:
Height: 27.9 cm (11 in.)
Width: 54.6 cm (21.5 in.)
Depth: 41.9 cm (16.5 in.)

Weight 13.6 kg (30 lb)

Power Power input requirement:


100–240 VAC, 50/60 Hz
Power supply output:
12 VDC, 11.5 A
Cytometer power:
12 VDC, 120 W (Max)
Heat output 240 BTU/hr maximum output

Operating temperature/ 15–30°C; 15–80% relative humidity


humidity
Laser excitation 488 nm
640 nm

Laser profile Blue laser beam: 9 x 94 µm


Red laser beam: 11 x 104 µm

Laser power 488 nm solid-state blue laser: 20 mW


640 nm diode red laser: 12.5 mW
Chapter 9: Technical specifications 153

Item Specification
Emission detection 4 colors, standard optical filters
 FL1 533/30 nm
 FL2 585/40 nm
 FL3 >670 nm
 FL4 675/25 nm

Optical alignment Fixed alignment

Flow cell 200-µm ID quartz capillary

Minimum detectable 0.5 µm


particle size
Minimum sample volume 50 µL (12 x 75-mm tubes)
150 µL (BD Trucount tubes)
100 µL (Loader, 12 x 75-mm tubes)

Flow rate 14–66 µL/min, depending on the test

Maximum events/sample 1 million events

Fluorescence sensitivity FITC <150


MESF*
PE <100

Fluorescence linearity 2 ±0.05% for chicken erythrocyte nuclei


(CEN)

Fluorescence precision ≤3% CV for CEN

Data acquisition rate 10,000 events/s, maximum

Fluid bottle capacity 2 L sheath, 2 L waste


250 mL BD FACSClean
250 mL Detergent Solution

Signal processing 24-bit datapath

Computer interface USB 2.0

* MESF values determined using Thermo Scientific Cyto-Cal™


Multifluor Plus Violet Beads.
154 BD FACSVia System Instructions for Use

Computer
specifications Item Specification
General PC desktop workstation with DVD drive

Dimensions Height: 33 cm (13 in.)


Width: 10.2 cm (4 in.)
Depth: 38.1 cm (15 in.)

Processor 64-bit multi-core processor running at


2.9 GHz or faster

Operating system Microsoft Windows® 7

Software Windows 7 Professional and BD FACSVia


clinical software

Storage 26 GB free hard disk space after operating


system and software application
installation

RAM 8 GB

USB ports Three USB ports, version 2.0 or greater

Accessories Windows-ready mouse and keyboard;


19-in. monitor with 1280 x 1024 or
higher resolution

Optional Loader
Item Specification
Dimensions Length: 50.8 cm (20 in.)
Width: 35.6 cm (14 in.)
Height: 20.3 cm (8 in.)

Weight 3.63 kg (8 lb)


Chapter 9: Technical specifications 155

Item Specification
Connection Serial

Tray Includes three fixed tube locations for


cleaning solutions

Compatible racks Custom 24-tube capacity

Optional barcode The optional 2D barcode reader, a Motorola® DS6707-HC


reader handheld imager, connects to computer through a USB connection,
and reads the following barcode standards.

Item Specification
Standards  Code 39
 Codabar
 Code 128
 Interleaved 2 or 5
 Universal Product Code (UPC)
 Maxicode
 DataMatrix
 PDF417
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Index
A files 131
acquisition overview 30–34
manual 83–86 preferences 35–41
rerunning samples 90 signing in 51
troubleshooting 145 traffic light 33
using Loader 87–89 worklist 80–82
workflow 76 workspace 30, 77–79
worklist 80–82 BD FACSVia system
adjusting See also cytometer
compensation 101–102 intended use 16
height of sample stage 25 overview 16, 18–24
QC markers 63–65 beads
regions 97–98 See CS&T beads
threshold 99–100 bottle
administrator BD FACSClean 23
tasks 128–130 detergent solution 23
user 32 filling 46
aligning Loader after collision 124–125 filters, replacing 113–114
sheath 23
waste 23
B
backflushing SIP 106
C
barcode reader 16, 155
BD FACSClean Clean Fluidics cycle 110
bottle 23 cleaning
filling 46 backflushing SIP 106
BD FACSLink Clean Fluidics cycle 110
configuring 135 extended flow cell clean 110–111
sending results 94 outside of instrument 106
troubleshooting 150 sample stage 52
BD FACSVia clinical software SIP clean 108–109
tubes, in Loader rack 28
158 BD FACSVia System Instructions for Use

compensation 101–102 startup workflow 44


computer detergent solution
overview 17 bottle 23
specifications 154 filling 46
connector downloading CS&T bead lot 60
Loader 20
power 20 E
CS&T beads 17
emptying waste 47
deleting old lots 134
enlarging plots 65
installing new lot 60
entering
running 58–60
CS&T bead lot 60
CSV results file, saving 133
reference ranges 40
cytometer
username and password 51
See also maintenance
worklist information 80–82
event indicator 19
event indicator 19
fluid bottles 23
exporting files 132
fluidics components 22–24
extended flow cell clean 110–111
lasers 22
optical components 21
optical filters 22 F
overview 16, 18–24 FACSClean
pumps 24 bottle 23
restarting after storage 126 filling 46
sample stage 19 FACSVia clinical software
shutdown 52–53 files 131
SIP 19, 24 overview 30–34
specifications 152–153 preferences 35–41
startup 49–51 signing in 51
startup workflow 44 traffic light 33
cytometer power worklist 80–82
button 19 workspace 30, 77–79
connector 20 FACSVia system
indicator 19 See also cytometer
intended use 16
D overview 16, 18–24
file
daily
exporting 132
maintenance 104
saving results CSV 133
QC workflow 57
search 132
shutdown 52–53
types 131
startup 49–51
159

filter saving 35–37


fluid bottle, replacing 113–114 viewing 92–94
in-line sheath 24, 114–116 lasers 22
optical 22 Levey-Jennings report
fluid bottles printing 74
emptying waste 47 viewing 72
filling 46 Loader
fluid sensing line 114 agitating rack 34, 88
overview 23 aligning after collision 124–125
replacing filters 113–114 cleaning tube locations 28
fluidics connector 20
components, overview 22–24 loading rack 27
harness 20 overview 26–29
tubing, replacing 116–119 running samples 87–89
fluids required 45 specifications 154
tips for use 29
G loading
24-tube rack 27
gate
sample tube 24
See region/gate

M
H
maintenance
hazard symbol definitions 12
See also cleaning
aligning Loader 124–125
I Clean Fluidics cycle 110
indicator daily 104
event 19 extended flow cell clean 110–111
power 19 replacing fluid bottle filters 113–114
in-line sheath filter replacing in-line sheath filter 114–
overview 24 116
replacing 114–116 replacing pump tubing 116–119
installing scheduled 104–105
CS&T bead lot 60 SIP clean 108–109
sample tube 24 unclogging SIP 121–124
intended use 16 unscheduled 105
wiping instrument 106
L mixing samples 34, 88
lab report
printing 37, 94
160 BD FACSVia System Instructions for Use

O summary report 37
optical pump
components 21 sheath 24
filters 22 tubing, replacing 116–119
overview waste 24
cytometer 18–24
fluid bottles 23 Q
Loader 26–29 QC
QC 56 current status 58
software 30–34 failed result 66
messages 69
P module 35, 56
password overview 56
entering 51 results 67–70
resetting 129 running 58–60
PC troubleshooting 147
overview 17 workflow 57
specifications 154 QC report
physician report adding comments 70
saving 35–37 adjusting markers 63–65
plots deleting from history list 133
QC 68 plots 68
zooming 65 printing 71
port, USB 20 results table 68
power viewing previous 70
button 19 zooming plots 65
connector 20
indicator 19 R
preferences rack
print 37 agitating 34, 88
reference ranges 40 loading 27
region/gate settings 39 map 28, 33
save locations 35 specifications 26
print reagents 17
preferences 37 reference ranges
printing preferences 40
lab report 37, 94 region/gate
Levey-Jennings report 74 adjusting QC 63–65
QC report 71 adjusting samples 97–98
161

preferences 39 save locations, preferences 35


replacing setting
fluid bottle filters 113–114 compensation 101–102
in-line sheath filter 114–116 language for reports 135
peristaltic pump tubing 116–119 software preferences 35–41
report threshold 99–100
lab 92–94 sheath
Levey-Jennings 72 bottle 23
physician 94 filling 46
QC 67–70 filter, in-line 24, 114–116
selecting language 135 pump 24
summary 95 shutting down 52–53
rerunning samples 90 SIP 19, 24
results backflushing 106
CSV file 133 clean cycle 108–109
QC 67–70 rinsing 34, 88
sample 92 unclogging 121–124
sending to LIS 94 software
running files 131
QC 58–60 overview 30–34
samples manually 83–86 preferences 35–41
samples using Loader 87–89 signing in 51
traffic light 33
S troubleshooting 143
worklist 80–82
safety symbol definitions 12
workspace 30, 77–79
sample injection probe
starting up 44, 49–51
See SIP
summary report
sample stage
printing 37, 38
adjusting height 25
saving 35–37
cleaning 52
loading tubes 24
overview 19 T
sample tube threshold 99–100
loading 24 traffic light 33
specifications 17 transferring results to LIS 94
samples troubleshooting
mixing 34, 88 acquisition 145
rerunning 90 FACSLink 150
running manually 83–86 hardware 138
running using Loader 87–89 overview 138
162 BD FACSVia System Instructions for Use

QC 147
software 143
tube
loading 24
specifications 17
tube rack
agitating 34, 88
loading 27
map 28, 33
specifications 26
tubing, replacing 116–119

U
USB port 20
user
adding 128
administrator 32
deleting 129
monitoring activity 129
resetting password 129
username, entering 51

W
waste
bottle 23
emptying 47
pump 24
workflow
acquisition 76
QC 57
startup 44
worklist 80–82
workspace 30, 77–79
workstation
overview 17
specifications 154

Z
zooming plots 65

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