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Beckman Coulter FP 1000 Manual

Beckman Coulter FP 1000 Manual

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

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Summary of Contents for Beckman Coulter FP 1000

  • Page 1 FP 1000 Cell Preparation System Reference PN 623112BA (May 2010) Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821...

  • Page 2: Warnings And Precautions

    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.

  • Page 3: Revision Status

    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.
  • Page 4 REVISION STATUS PN 623112BA...

  • Page 5: Table Of Contents

    OVERVIEW, 1-1 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 OPTIONS, 1-2 Instrument Manager, 1-2 Work Cell, 1-2 REAGENTS AND QUALITY CONTROL MATERIALS, 1-2 IMMUNOPREP™...
  • Page 6 CONTENTS SPECIAL REQUIREMENTS, 2-1 Space and Accessibility, 2-1 Electrical Input, 2-2 Ambient Temperature and Humidity, 2-2 Drainage, 2-2 FP 1000 SOFTWARE INSTALLATION, 2-3 REAGENT AND WASTE CONNECTIONS, 2-3 SYSTEM CONNECTIONS, 2-4 TRAINING CHECKLIST, 2-5 General, 2-5 Instrument Components, 2-5 Daily...
  • Page 7 2000, B-2 Third-Party Software Applications, B-2 AUDIT TRAILS, B-2 ELECTRONIC SIGNATURES, B-2 GLOSSARY, GLOSSARY-1 INDEX, INDEX-1 BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT, 1 May:, 1 You May Not:, 1 Limited Warranty, 1 No Liability for Consequential Damages, 1...
  • Page 8 CONTENTS ILLUSTRATIONS FP 1000 , 1-1 Reagent and Waste Container Tubing Connections, 2-3 System Connections, 2-4 FP 1000 Dimensions, 3-1 viii PN 623112BA...

  • Page 9: Introduction

    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: Reference manual for instrument specifications and information on installation.

  • Page 10: Conventions

    INTRODUCTION CONVENTIONS CONVENTIONS This manual uses the following conventions: Throughout this manual, your FP 1000 is also referred to as the system or instrument. Bold font indicates a software option. Example: Panel Editor Italics font indicates screen text displayed on the instrument Example: Please verify your carousel(s) and consumables.

  • Page 11: To Choose A Command With The Keyboard

    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.
  • Page 12 INTRODUCTION COMPUTER PROGRAM STATEMENT PN 623112BA...

  • Page 13: Use And Function

    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. SYSTEM OVERVIEW 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.

  • Page 14: Fp 1000 System Software (System Ui)

    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.

  • Page 15: Rinse Fluid

    USE AND FUNCTION REAGENTS AND QUALITY CONTROL MATERIALS 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.

  • Page 16: Material Safety Data Sheets (Msds)

    USE AND FUNCTION MATERIAL SAFETY DATA SHEETS (MSDS) MATERIAL SAFETY DATA SHEETS (MSDS) To obtain an MSDS for Beckman Coulter reagents used on the FP 1000, follow these steps: On the Internet, go to www.beckmancoulter.com: Select MSDS from the Customer Support drop-down menu.

  • Page 17: Installation

    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. When you receive your instrument, carefully inspect all cartons. If you see signs of mishandling or damage, file a claim with the carrier immediately.

  • Page 18: Electrical Input

    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.

  • Page 19: Fp 1000 Software Installation

    Ensure that the waste tubing never exceeds the height of the waste drain port on the instrument. 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. REAGENT AND WASTE CONNECTIONS Figure 2.1...

  • Page 20: System Connections

    NOVE BECKM MBER 4300 AN COULT 2006 FULLE N. HARBO ER INC. RTON, CA 92835 R BLVD. 2427796 Bar-code reader Audio cable Keyboard Power cord, monitor Power cord, computer Serial cable Mouse Power cord, FP 1000 Data cable PN 623112BA...

  • Page 21: Training Checklist

    Differentiate between the carousel used for polypropylene tubes and the one used for polystyrene tubes. Demonstrate how to properly open the carousel drawer and carousel doors. Explain the importance of waiting at least 10 seconds after you turn the FP 1000 power switch off before you turn it back on again. Daily Procedures Review the start-up procedures and how to inspect the sample probe for normal and abnormal wear.

  • Page 22: Panel Definition Software

    FC 500 with CXP software. (Note: This does not apply to the four 4_Color_Mix tetra panels.) Set up FP 1000, FC 500 with CXP software, and/or XL-MCL panels with the correct panel name based on the type of tetra panel you are running.

  • Page 23: Controls And Calibrators

    INSTALLATION TRAINING CHECKLIST Controls and Calibrators Review how to reconstitute controls and calibrators on the FP 1000. Review how to load controls and calibrators into the control/cal rack, noting to check for bubbles/foam. Note that the IMMUNO-TROL control tube must be bar-coded and run in a CONTROL cassette.

  • Page 24: Special Procedures

    Complete this training checklist. Place the original in the laboratory log book. The Beckman Coulter Representative should fax a copy of the signed training checklist to BCI Technical Support (305) 380-2719. Complete a training checklist for each operator trained on the FP 1000. Training Checklist Completed Operator (Trainee):...

  • Page 25: Specifications

    SPECIFICATIONS OVERVIEW The information in this section includes: INSTRUMENT SPECIFICATIONS PERFORMANCE SPECIFICATIONS INSTRUMENT SPECIFICATIONS Figure 3.1 FP 1000 Dimensions 91 kg (200 lb.) 31 cm (12 in.) 82 cm (32 in.) 77 cm 123 cm (30 in.) (48 in.) Dimensions...

  • Page 26: Liquid Handling

    SPECIFICATIONS INSTRUMENT SPECIFICATIONS Liquid Handling Volume Range Pipetting Module - 5-1,000 µL Syringe Pump Sizes Aspiration/Dispense syringe - 2 mL Wash/Prime syringe - 5 mL IMMUNOPREP reagents A, B, C - 2 mL (one syringe for each reagent) Flow-Count syringe - 2 mL Power Requirements Installation Category Overvoltage Category II...

  • Page 27: Specimen Type

    2 mL (10.25 X 47 or 50 mm) pediatric tubes in 2 mL tube adaptors Sarstedt tubes Note: Sarstedt tubes must be set up by your Beckman Coulter Representative. Do not mix these tubes in the same cassette. Each tube type will go in its own cassette based on the cassette bar code.

  • Page 28: Carousel Tubes (Daughter Tubes)

    Use manual for an illustration. Throughput Throughout is 80 daughter tubes per hour when running batch mode tetraCHROME™ reagents. Random access mode throughput is panel-dependent. Workstation The descriptions below are approved configurations. Contact your Beckman Coulter Representative on current configuration availability. Computer ® ®...

  • Page 29: Performance Specifications

    SPECIFICATIONS PERFORMANCE SPECIFICATIONS PERFORMANCE SPECIFICATIONS Accuracy and Precision IMMUNOPREP Reagent System Dispensing Reagent Volume (µL) Precision (CV) Accuracy (± % of volume) IMMUNOPREP A <5% ±5% IMMUNOPREP B <5% ±5% IMMUNOPREP C <5% ±5% Pipetting Module - Reagents Dispense Volume (µL) *Accuracy (g of water) **Precision (CV) 1000...
  • Page 30 SPECIFICATIONS PERFORMANCE SPECIFICATIONS PN 623112BA...

  • Page 31: Log Sheets

    LOG SHEETS This appendix contains the following log sheets: Maintenance and Operational Checks Log Reagent Log Action Log Make photocopies, as needed. PN 623112BA...
  • Page 32 LOG SHEETS PN 623112BA...
  • Page 33 LOG SHEETS MAINTENANCE AND OPERATIONAL CHECKS LOG Clean Probe and Startup Specimen Cap Shutdown Indicate Procedure Date Tech Pierce Counter Date Tech Date Tech Instrument Serial No: Laboratory: PN 623112BA...
  • Page 34 LOG SHEETS PN 623112BA...
  • Page 35 LOG SHEETS REAGENT LOG Concentration Date Date Expiration Reagent Name Lot Number Tech Units= Received Opened Date (If applicable) Instrument Serial No: Laboratory: PN 623112BA...
  • Page 36 LOG SHEETS PN 623112BA...
  • Page 37 LOG SHEETS ACTION LOG Condition Noted Date Tech Date Action Taken Tech Instrument Serial No: Laboratory: PN 623112BA...
  • Page 38 LOG SHEETS PN 623112BA...

  • Page 39: 21 Cfr Part 11 Regulation Support Tools

    FP 1000 as described in this section can be used to achieve compliance with this regulation. The FP 1000 is a closed system per the definition stated in Section 11.3, Subpart A of the regulation: Closed System - environment in which system access is controlled by persons responsible for the content of electronic records on the system.

  • Page 40: Paneldef And System Software

    21 CFR PART 11 REGULATION SUPPORT TOOLS AUDIT TRAILS PanelDef and System Software The administrator for the FP 1000 controls user access to PanelDef and/or System software. Any logged-on user can lock the FP 1000 System screen. Windows 2000 The system administrator should use the security and access features provided by Windows 2000.
  • Page 41 GB - Acronym for gigabyte. Indicators - See Controls and indicators. IQAP - Acronym for Beckman Coulter's Interlaboratory Quality Assurance Program. A service for all worldwide users of IMMUNO-TROL cells and CYTO-TROL control cells, the IQAP statistically compares your control data with that of other laboratories.
  • Page 42 GLOSSARY LIS - Acronym for Laboratory Information System. Laser - Acronym for light amplification by stimulated emission of radiation. The standard laser is in the flow cell for analyzing cells. MB - Acronym for megabyte. Mean - Arithmetic average of a group of data. See also Standard deviation and Coefficient of variation.
  • Page 43 INDEX Numerics data, serial, 21CFR Part 11 carousel tubes, administrator access, cassette sizes, audit trail, category, installation, electronic signatures, CD-ROM, Operator Manuals, integrity of electronic data, overview, checklist, training, passwords, cleaning agent support tools, definition, GLOSSARY-1 third-party applications, description, user access, click, definition of, GLOSSARY-1 Windows 2000 security features,...
  • Page 44 GLOSSARY-1 drives, Flow-Count specifications, description, daughter tube, fluorospheres dispensing, fluorospheres, definition, GLOSSARY-1 For Research Use Only, limit, FP 1000 dc, definition of, GLOSSARY-1 components description, default, definition of, GLOSSARY-1 installation, definitions, GLOSSARY-1 manuals, hard-copy, degree, pollution, Panel Definition software, delivery inspection, instrument,...
  • Page 45 Lyse - Ammonium Chloride, FP 1000 software, lysing overview, reagent, instrument solution accessibility, Ammonium Chloride, delivery inspection, IOTest 3, dimensions, VersaLyse,...
  • Page 46 FP 1000, scroll bar, definition of, GLOSSARY-2 instrument, SD (standard deviation), definition monitor, GLOSSARY-2 precision, select, definition of, GLOSSARY-2 precision (reproducibility), definition serial cable connection,...
  • Page 47 INDEX size, See pop-up window tube size, Windows security features, type, work cell, SQL, definition of, GLOSSARY-2 workstation stabilizing reagent, definition, GLOSSARY-2 standard deviation (SD) description, See SD (standard deviation) specifications, syringe pumps sizes, system components, connections, System software, system UI, temperature, ambient operating, 2-2, third-party software application, throughput,...
  • Page 48 INDEX INDEX-6 PN 623112BA...

  • Page 49: Beckman Coulter, Inc. Customer End User License Agreement

    BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is protected by United States and international copyright laws and international trade provisions. You must treat the software contained in this Product like any other copyrighted material.

  • Page 51: Trademarks

    TRADEMARKS BECKMAN COULTER logo, COULTER, COULTER CLENZ, CYTO-TROL, EPICS, Flow-Count, IMMUNOPREP , IMMUNO-TROL, IsoFlow, tetraONE, and XL-MCL are trademarks of Beckman Coulter, Inc. All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders.

  • Page 52: Fp 1000 Documentation

    Troubleshooting • Bar-Code Specifications • Specimen Tube Sizes • References • Index Come visit us at www.beckmancoulter.com Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda, Printed on Recycled Paper Estr dos Romeiros, 220 - Galpao G3 - Km 38.5 Copyright ©...

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