Beckman Coulter FP 1000 User manual

FP 1000
Cell Preparation System
Reference
PN 623112BA (May 2010)
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

WARNINGS AND PRECAUTIONS
READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING
TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL
INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS
TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE.
BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY
STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO,
PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR
ANY OTHER AUTOMATED LABORATORY ANALYZER.
HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS
WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:
WARNING - Can cause injury.
CAUTION - Can cause damage to the instrument.
IMPORTANT - Can cause misleading results.
WARNING Risk of operator injury if:
r All doors, covers, and panels are not closed and secured in place prior to and during instrument operation.
r The integrity of safety interlocks and sensors is compromised.
r Instrument alarms and error messages are not acknowledged and acted upon.
r You contact moving parts.
r You mishandle broken parts.
r Doors, covers, and panels are not opened, closed, removed, and/or replaced with care.
r Improper tools are used for troubleshooting.
To avoid injury:
r Keep doors, covers, and panels closed and secured in place while the instrument is in use.
r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.
r Acknowledge and act upon instrument alarms and error messages.
r Keep away from moving parts.
r Report any broken parts to your Beckman Coulter Representative.
r Open/remove and close/replace doors, covers, and panels with care.
r Use the proper tools when troubleshooting.
CAUTION System integrity might be compromised and operational failures might occur if:
r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals.
r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s
computer with software authorized by Beckman Coulter.
r You install software that is not an original copyrighted version. Only use software that is an original copyrighted
version to prevent virus contamination.
IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter
distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot
guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most
current information bulletins concerning the product. If you purchased this product from a third party and would like
further information concerning this topic, call your Beckman Coulter Representative.

iii
PN 623112BA
REVISION STATUS
Issue A, 01/05
Software Version 1.0
Revision B, 10/07
Software Version 1.4
Change bars identify additions, changes, and deletions made to these pages:
1-2, 1-3, 2-2, 2-4, 2-7, 3-2, 3-3, 3-4, and 3-5
Revision BA, 05/10
Software Version 1.4.
Updates were made to the company corporate address.
Note: Changes that are part of the most recent revision are indicated in text by a bar in the
margin of the amended page.
This document applies to the latest software listed and higher versions. When a subsequent software version
changes the information in this document, a new issue will be released to the Beckman Coulter website. For
labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for
your instrument.

PN 623112BA
iv
REVISION STATUS

PN 623112BA v
CONTENTS
WARNINGS AND PRECAUTIONS
REVISION STATUS, iii
INTRODUCTION,ix
USING YOUR FP 1000 MANUALS,ix
ABOUT THIS MANUAL,ix
CONVENTIONS,x
To Choose a Command with the Keyboard,xi
Dialog Box,xi
GRAPHICS,xi
COMPUTER PROGRAM STATEMENT,xi
1 USE AND FUNCTION,1-1
1.1 OVERVIEW,1-1
1.2 SYSTEM COMPONENTS,1-1
FP 1000 Instrument,1-1
Workstation,1-1
FP 1000 System Software (System UI),1-2
FP 1000 Panel Definition Software (Panel Def),1-2
1.3 OPTIONS,1-2
Instrument Manager,1-2
Work Cell,1-2
1.4 REAGENTS AND QUALITY CONTROL MATERIALS,1-2
IMMUNOPREP™ Reagent System,1-2
IMMUNOPREP A,1-2
IMMUNOPREP B,1-2
IMMUNOPREP C,1-2
Rinse Fluid,1-3
Cleaning Agent,1-3
Flow-Count™ Fluorospheres,1-3
IMMUNO-TROL™ Cells and IMMUNO-TROL Low Cells,1-3
Additional Lysing Reagents,1-3
IOTest® 3 Lysing Solution,1-3
VersaLyse Lysing Solution,1-3
1.5 MATERIAL SAFETY DATA SHEETS (MSDS),1-4
2INSTALLATION,2-1
2.1 OVERVIEW,2-1
2.2 DELIVERY INSPECTION,2-1

PN 623112BA
vi
CONTENTS
2.3 SPECIAL REQUIREMENTS,2-1
Space and Accessibility,2-1
Electrical Input,2-2
Ambient Temperature and Humidity,2-2
Drainage,2-2
2.4 FP 1000 SOFTWARE INSTALLATION,2-3
2.5 REAGENT AND WASTE CONNECTIONS,2-3
2.6 SYSTEM CONNECTIONS,2-4
2.7 TRAINING CHECKLIST,2-5
General,2-5
Instrument Components,2-5
Daily Procedures,2-5
Panel Definition Software,2-6
System Software,2-6
Controls and Calibrators,2-7
Reagents,2-7
Specimens,2-7
System Operation,2-7
Special Procedures,2-8
Miscellaneous,2-8
3 SPECIFICATIONS,3-1
3.1 OVERVIEW,3-1
3.2 INSTRUMENT SPECIFICATIONS,3-1
Dimensions,3-1
Liquid Handling,3-2
Volume Range,3-2
Syringe Pump Sizes,3-2
Power Requirements,3-2
Installation Category,3-2
Input Voltages,3-2
Frequency,3-2
Maximum Power,3-2
Noise,3-2
Operating Temperature Range,3-2
Operating Humidity Range,3-2
Safety,3-2
Pollution,3-2
Altitude,3-2
Specimen Type,3-3
Anticoagulant,3-3
Specimen Size,3-3
Specimen Tube Size,3-3
Specimen Cassette Sizes,3-3
Carousel Tubes (Daughter Tubes),3-4

PN 623112BA vii
CONTENTS
Throughput,3-4
Workstation,3-4
Computer,3-4
Data Storage,3-4
Interfaces,3-4
Input Devices,3-4
Monitor,3-4
Communications,3-4
3.3 PERFORMANCE SPECIFICATIONS,3-5
Accuracy and Precision,3-5
IMMUNOPREP Reagent System Dispensing,3-5
Pipetting Module - Reagents,3-5
Pipetting Module - Specimens***,3-5
Flow-Count Fluorospheres Dispensing,3-5
ALOGSHEETS,A-1
B 21 CFR PART 11 REGULATION SUPPORT TOOLS,B-1
B.1 OVERVIEW,B-1
B.2 INTEGRITY OF ELECTRONIC DATA,B-1
Passwords,B-1
PanelDef and System Software,B-2
Windows 2000,B-2
Third-Party Software Applications,B-2
B.3 AUDIT TRAILS,B-2
B.4 ELECTRONIC SIGNATURES,B-2
GLOSSARY,GLOSSARY-1
INDEX,INDEX-1
BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT,1
You May:,1
You May Not:,1
Limited Warranty,1
No Liability for Consequential Damages,1
General,1
TRADEMARKS
FP 1000 Documentation

PN 623112BA
viii
CONTENTS
ILLUSTRATIONS
1.1 FP 1000 ,1-1
2.1 Reagent and Waste Container Tubing Connections,2-3
2.2 System Connections,2-4
3.1 FP 1000 Dimensions,3-1

PN 623112BA ix
INTRODUCTION
This introductory section contains the following topics:
r USING YOUR FP 1000 MANUALS
r ABOUT THIS MANUAL
r CONVENTIONS
r GRAPHICS
USING YOUR FP 1000 MANUALS
The manuals and master index listed below are available as PDF files in the FP 1000 software
and on the FP 1000 Operator Manuals CD-ROM. See the:
r Reference manual for instrument specifications and information on installation.
r Instructions For Use manual for the day-to-day running of your instrument including
detailed step-by-step procedures for start-up, quality control (QC), running samples, and
shutdown. This manual also contains safety and
troubleshooting information, error
messages,
information about what your instrument does, the methods it uses, and
component names and functions. You will find information about setting up custom
panels using the Panel Definition (Panel Def) software.
r Special Procedures manual for procedures on how to clean, replace, or adjust a
component of the instrument.
r Master Index to easily locate a topic in any of your manuals.
Printed versions of the manuals are also available by order.
ABOUT THIS MANUAL
Your FP 1000 Reference manual provides instrument specifications and information on
installation, safety, and software features.
This information is organized as follows:
r Chapter 1, USE AND FUNCTION
Contains a short description of the major instrument components and options, and the
reagents and quality control materials used.
r Chapter 2, INSTALLATION
Contains instrument requirements and a diagram of the reagent and waste connections.
r Chapter 3, SPECIFICATIONS
Details the instrument and performance specifications.
r Appendices
Provide reference material on the following topics:
t LOG SHEETS
t 21 CFR PART 11 REGULATION SUPPORT TOOLS
r GLOSSARY
Contains definitions for many of the words and terms used in flow cytometry.
r INDEX
Lets you easily locate specific information in this manual.

PN 623112BA
x
INTRODUCTION
CONVENTIONS
CONVENTIONS
This manual uses the following conventions:
r Throughout this manual, your FP 1000 is also referred to as the system or instrument.
r Bold font indicates a software option. Example: Panel Editor
r Italics font indicates screen text displayed on the instrument
Example: Please verify your carousel(s) and consumables.
r Courier font indicates text you type using the keyboard.
r ë indicates a key. Example: Û
r ë+ë indicates that the two keys listed, such as Þ+Ê, are linked for a specific
function and must be pressed in this sequence:
a. Press the first key listed and while pressing it, press the second key listed.
b. Release both keys at the same time.
r ëëindicates to press and release the first key listed; then press and release the next
key listed. Example: YÛ
r Icons/buttons to select functions on the software screen are shown within text.
Example: .
r indicates to click the mouse on the screen button labeled
.
r Security tt Change Password indicates to click the mouse on Change Password from the
Security menu.
r Éthrough Ô are special function keys.
r A Note contains information that is important to remember or helpful in performing a
procedure.
r The terms screen and window are used interchangeably.

PN 623112BA xi
INTRODUCTION
GRAPHICS
To Choose a Command with the Keyboard
After you press Þ, each menu name has one letter underlined to indicate which letter to use
to display its menu drop-down list. For example, the letter Fin the File menu is underlined,
so press Fto display the File menu drop-down list; the letter Ein the Edit menu is
underlined, so press Eto display the Edit menu drop-down list.
Dialog Box
Dialog boxes receive commands or information; for example, a file name dialog box receives
information about a file name.
GRAPHICS
All graphics, including screens and printouts, are for illustration purposes only and must not
be used for any other purpose.
COMPUTER PROGRAM STATEMENT
Warning: This computer program is protected by international copyright laws, and
unauthorized copying, use, distribution, transfer, or sale is a violation of those laws that may
result in civil or criminal penalties. This computer program may also be subject to additional
restrictions contained in a license granted by Beckman Coulter, Inc. to the authorized user of
this computer program or to the authorized owner or other authorized user of the system
onto which this computer program is installed. Any violation of the license provisions may
result in additional civil penalties, including an injunction and damages. Please refer to the
computer program or system agreement or to the computer program or system
documentation for the terms and conditions of that license.
Command Function
ÛAccepts your selection
ÈStops the operation, discarding your choices
ÙMoves cursor over different choices that have multiple options - see Windows®manuals
for Windows operation via keyboard
Þ+Ù When you have more than one application Window open, use Þ+Ù to switch between
tasks
Accepts the information you have selected or typed
Stops the operation, ignoring your choices

PN 623112BA
xii
INTRODUCTION
COMPUTER PROGRAM STATEMENT

PN 623112BA 1-1
1
1USE AND FUNCTION
1.1 OVERVIEW
The information in this section includes:
r SYSTEM COMPONENTS
r OPTIONS
r REAGENTS AND QUALITY CONTROL MATERIALS
r MATERIAL SAFETY DATA SHEETS (MSDS)
1.2 SYSTEM COMPONENTS
The system components are shown in Figure 1.1:
Figure 1.1 FP 1000
FP 1000 Instrument
The FP 1000 instrument automatically pipets, dilutes, incubates, and lyses samples.
See SYSTEM OVERVIEW and OPERATION PRINCIPLES in the Instructions For Use manual
for more information.
Workstation
The workstation runs the software that enables you to control the instrument and define
panels. It consists of a:
r Monitor
r Computer with data storage devices
r Keyboard and a mouse
r Handheld bar-code reader

PN 623112BA
1-2
USE AND FUNCTION
OPTIONS
FP 1000 System Software (System UI)
The System software (System UI) provides all the functions necessary to set up, run, monitor,
and maintain the FP 1000 instrument. See FP 1000 SYSTEM SOFTWARE in the Instructions
For Use manual for more information.
FP 1000 Panel Definition Software (Panel Def)
The Panel Definition (Panel Def) software provides all the functions necessary to define racks
and panels and, in some workflow scenarios, assign tests to patient specimens. See FP 1000
PANEL DEFINITION SOFTWARE in the Instructions For Use manual for more information.
1.3 OPTIONS
Instrument Manager
Instrument Manager™ by Data Innovations, Inc.®is a software application that provides for
the sharing of information between the laboratory information system (LIS)/host and
individual instruments. If you are interested in this option, contact your Beckman Coulter
Representative.
Work Cell
The FP 1000 can be used as a stand-alone instrument or as a subsystem of a work cell. A work
cell consists of up to two FP 1000 instruments and up to eight cytometers, with a maximum
of four cytometers per FP 1000. The cytometers that can be used within this work cell are the
Cytomics FC 500 with CXP software and COULTER®EPICS®XL-MCL™ Flow Cytometer.
The work cell is linked via Ethernet to provide consolidated data management and results
reporting. If you are interested in this option, contact your Beckman Coulter Representative.
1.4 REAGENTS AND QUALITY CONTROL MATERIALS
Beckman Coulter recommends these reagents or their equivalents. All stated performance
characteristics in this manual are based on the use of the FP 1000 system with the following
reagents:
IMMUNOPREP™ Reagent System
IMMUNOPREP A
IMMUNOPREP A, a lysing reagent, causes simultaneous rapid destruction of the erythrocytes
while leaving the leukocytes intact.
IMMUNOPREP B
IMMUNOPREP B, a stabilizing reagent, stops the action of the lysing reagent
(IMMUNOPREP A).
IMMUNOPREP C
IMMUNOPREP C, a fixing reagent, fixes the cell membranes. This preserves the form and
structure of the leukocytes.
See the package insert for more information.

PN 623112BA 1-3
USE AND FUNCTION
REAGENTS AND QUALITY CONTROL MATERIALS 1
Rinse Fluid
Use a non-fluorescent, balanced electrolyte reagent, such as IsoFlow™ sheath fluid, for the
rinse fluid. The rinse fluid is used, in part, to clean the sample probe. Read the container’s
label for more information.
Cleaning Agent
COULTER CLENZ®cleaning agent cleans and rinses the sample probe. Using it daily
prevents protein buildup on the sample probe. Read the container’s label for more
information.
Flow-Count™ Fluorospheres
Flow-Count Fluorospheres is a suspension of fluorospheres used to determine absolute
counts on the flow cytometer. See the package insert for additional information.
IMMUNO-TROL™Cells and IMMUNO-TROL Low Cells
These control materials contain stabilized erythrocytes and leukocytes with a known quantity
of surface antigens. They are used to verify monoclonal antibody performance as well as to
verify the process of sample staining, lysing, and analysis. See the package inserts for
additional information.
Additional Lysing Reagents
IOTest®3 Lysing Solution
IOTest 3 Lysing Solution is a 10X concentration of Ammonium Chloride. Dilute 1:10 to create
a working solution before use. For Research Use Only. Not for use in diagnostic procedures.
See the package insert for more information.
VersaLyse Lysing Solution
VersaLyse Lysing Solution is a general-purpose reagent used to lyse erythrocytes. For
Research Use Only. Not for use in diagnostic procedures. See the package insert for more
information.

PN 623112BA
1-4
USE AND FUNCTION
MATERIAL SAFETY DATA SHEETS (MSDS)
1.5 MATERIAL SAFETY DATA SHEETS (MSDS)
To obtain an MSDS for Beckman Coulter reagents used on the FP 1000, follow these steps:
1. On the Internet, go to www.beckmancoulter.com:
a. Select MSDS from the Customer Support drop-down menu.
b. Follow the instructions on the screen.
c. Contact your Beckman Coulter Representative if you have difficulty locating the
information.
2. If you do not have Internet access:
r In the USA, either call Beckman Coulter Customer Operations (800-526-7694) or
write to:
Beckman Coulter, Inc.
Attn: MSDS Requests
P.O. Box 169015
Miami, FL 33116-9015
r Outside the USA, contact your Beckman Coulter Representative.

PN 623112BA 2-1
2
2INSTALLATION
2.1 OVERVIEW
The information in this section includes:
r DELIVERY INSPECTION
r SPECIAL REQUIREMENTS
r FP 1000 SOFTWARE INSTALLATION
r REAGENT AND WASTE CONNECTIONS
r SYSTEM CONNECTIONS
r TRAINING CHECKLIST
2.2 DELIVERY INSPECTION
The instrument is tested before shipping. International symbols and special handling
instructions are printed on the shipping cartons to inform the carrier of the precautions and
care applicable to electronic instruments.
When you receive your instrument, carefully inspect all cartons. If you see signs of
mishandling or damage, file a claim with the carrier immediately. If separately insured, file the
claim with the insurance company.
2.3 SPECIAL REQUIREMENTS
Before your Beckman Coulter Representative arrives to install the instrument, you must
determine where you want the system placed and the overall layout. Consider the factors
described in the following paragraphs:
Space and Accessibility
In addition to the space required for the FP 1000, also arrange for:
r Comfortable working height
r Space for computer(s) and monitor(s)
r Space for IsoFlow and waste containers
r Adequate space in front to open the instrument doors
r Space for ventilation, and access for maintenance and service
CAUTION Risk of instrument damage. Possible instrument damage could occur if you uncrate the
instrument, install it, or set it up. Keep the instrument in its packaging until your Beckman Coulter
Representative uncrates it for installation and setup.

PN 623112BA
2-2
INSTALLATION
SPECIAL REQUIREMENTS
Electrical Input
This system requires:
r An independent, protected circuit
r A ground path capable of carrying the full current of the circuit (confirmed third-wire,
earth ground)
r A transient-protected outlet
r A non-GFI receptacle (circuit)
The computer requires a separate outlet, but it does not have to be a dedicated line.
Ambient Temperature and Humidity
The operating temperature range of the instrument is 16-32°C (60-90°F).
The operating humidity range is 30-85%, without condensation.
For information on an individual reagent, see its package insert.
Drainage
The waste line from the FP 1000 is connected to a 20-L waste container. Dispose of the waste
in accordance with your local environmental regulations and acceptable laboratory
procedures.
Instrument Specifications
Height
Additional clearance above for servicing
Total clearance needed
82 cm (32 in.)
62 cm (24 in.) min.
144cm(56in.)
Width
Additional clearance on right for servicing
Additional clearance on left for servicing
Total clearance needed
123cm(48in.)
31 cm (12 in.)
31 cm (12 in.)
185cm(72in.)
Depth
Additional clearance behind instrument
for sufficient cooling and room for
servicing
Total clearance needed
77 cm (30 in.)
31 cm (12 in.)
108cm(42in.)
CAUTION Risk of instrument damage. Do not use an extension cord. Overheating, melting, and burning of
the extension cord can occur. Plug the power cord directly into an electrical outlet. Position the instrument
close enough to an electrical outlet so you do not need to use an extension cord.
WARNING Risk of operator injury. Risk of biohazardous contamination if you have skin contact with the
waste container, its contents, and its associated tubing. The waste container and its associated tubing
might contain residual biological material and must be handled with care. Clean up spills immediately.
Dispose of the contents of the waste container in accordance with your local regulations and acceptable
laboratory procedures.

PN 623112BA 2-3
INSTALLATION
FP 1000 SOFTWARE INSTALLATION 2
The waste line supplied with the instrument can be connected to an open drain. If you use an
open drain, mechanically secure the waste tube into the drain so the tube cannot accidentally
come out of the drain. This prevents spillage.
Ensure that the waste tubing never exceeds the height of the waste drain port on the
instrument.
2.4 FP 1000 SOFTWARE INSTALLATION
Only administrator-level users for a PC can install the FP 1000 software. Both administrator
and standard users for a PC can run the FP 1000 software.
2.5 REAGENT AND WASTE CONNECTIONS
Figure 2.1 shows the tubing connections from the instrument to the various reagent and
waste containers.
Note: Ensure that:
r The reagent tubing does not exceed the height of the instrument
r The waste tubing does not exceed the height of the waste drain port on the instrument
Figure 2.1 Reagent and Waste Container Tubing Connections

PN 623112BA
2-4
INSTALLATION
SYSTEM CONNECTIONS
2.6 SYSTEM CONNECTIONS
Figure 2.2 shows the connections of the instrument to the computer and the computer to its
components:
Figure 2.2 System Connections
bBar-code reader gAudio cable
cKeyboard hPower cord, monitor
dPower cord, computer iSerial cable
eMouse jPower cord, FP 1000
fData cable
Manufactured
DA
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BY:
THISLASERPRODUCTCONFORMS
TOTHEPROVISIONSOF21CFR,
SUBCHAPTERJ,SECTIONS
1040.10AND1040.11.
2427796
NOVEMBER 2006
BECKMAN COULTER INC.
4300 N. HARBOR BLVD.
FULLERTON,CA 92835 USA
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