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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.

Содержание FP 1000

Страница 1: ...FP 1000 Cell Preparation System Reference PN 623112BA May 2010 Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 ...

Страница 2: ...ooting 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 clo...

Страница 3: ... 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 beckmancou...

Страница 4: ...PN 623112BA iv REVISION STATUS ...

Страница 5: ...stem 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 ...

Страница 6: ...nd 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 Ope...

Страница 7: ...ount Fluorospheres Dispensing 3 5 A LOG SHEETS 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 ...

Страница 8: ...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 ...

Страница 9: ...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 in...

Страница 10: ...cific 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 ë ë indicates to press and release the first key listed then press and release the next key listed Example Y Û r Icons buttons to select functions on the software screen are shown within text Example r indicates to click the mouse...

Страница 11: ...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 provisi...

Страница 12: ...PN 623112BA xii INTRODUCTION COMPUTER PROGRAM STATEMENT ...

Страница 13: ...n 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 devic...

Страница 14: ...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 repo...

Страница 15: ... 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 Lysi...

Страница 16: ...ect 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 c...

Страница 17: ...nsured 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 he...

Страница 18: ... needed 82 cm 32 in 62 cm 24 in min 144 cm 56 in Width Additional clearance on right for servicing Additional clearance on left for servicing Total clearance needed 123 cm 48 in 31 cm 12 in 31 cm 12 in 185 cm 72 in Depth Additional clearance behind instrument for sufficient cooling and room for servicing Total clearance needed 77 cm 30 in 31 cm 12 in 108 cm 42 in CAUTION Risk of instrument damage ...

Страница 19: ...t 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 h...

Страница 20: ...System Connections b Bar code reader g Audio cable c Keyboard h Power cord monitor d Power cord computer i Serial cable e Mouse j Power cord FP 1000 f Data cable Manufactured DATE BY THIS LASER PRODUCT CONFORM S TOTHE PROVISIO NS OF 21 CFR SUBCHAP TER J SECTIONS 1040 10 AND 1040 11 2427796 NOVEMBE R 2006 BECKMAN COULTER INC 4300 N HARBOR BLVD FULLERTO N CA 92835 USA b c d e h i j f g ...

Страница 21: ...fy the different types of racks B Identify the different types of cassettes and specimen tube adaptors B Describe the cassette bar code system B Demonstrate how to apply a bar code label to a cassette B Describe the carousel bar code system B Identify the FP 1000 carousel reflective disk on underside B Differentiate between the carousel used for polypropylene tubes and the one used for polystyrene...

Страница 22: ...B Demonstrate how to use Specimen Editor B Demonstrate how to access the Help system B Demonstrate how to access and use the Audit Trail B Launch and log on to the System software B All users demonstrate how to change your password B Administrators only demonstrate how to add and modify a user B Use tool tips to identify the icons on the toolbar B Use icons or drop down menus to access the necessa...

Страница 23: ...st requirements B Review how to load reagents into the different reagent racks Small Large Small Large Bulk noting to check for bubbles foam B Review how to properly prepare and load Flow Count fluorospheres noting to check for bubbles foam B Demonstrate how to replace the IsoFlow container and empty the waste B Demonstrate how to replace IMMUNOPREP reagents VersaLyse Lysing solution and or IOTest...

Страница 24: ...tment schedule and procedures B Locate the error messages tables and other troubleshooting information in the Help system B Explain the error recovery codes B Locate the message log in the System software B Ensure that the customer service telephone number is clearly noted B Ensure that the customer knows where the System Identification SID number and instrument serial number are located B Complet...

Страница 25: ...T SPECIFICATIONS Figure 3 1 FP 1000 Dimensions Dimensions 123 cm 48 in 77 cm 30 in 82 cm 32 in 31 cm 12 in 91 kg 200 lb Component Height Width Depth Weight FP 1000 82 cm 32 in 123 cm 48 in 77 cm 30 in 91 kg 200 lb Computer 15 9 cm 6 2 in 53 9 cm 21 in 43 0 cm 16 8 in 18 1 kg 40 lb Monitor typical 43 1 cm 16 8 in 40 8 cm 15 9 in 44 3 cm 17 3 in 22 kg 48 4 lb ...

Страница 26: ...PREP reagents A B C 2 mL one syringe for each reagent r Flow Count syringe 2 mL Power Requirements Installation Category Overvoltage Category II Input Voltages 100 240 Vac Frequency 48 62 Hz Maximum Power 150 W Noise Less than or equal to 65 db Operating Temperature Range 16 32 C 60 90 F Operating Humidity Range 30 85 without condensation Safety UL CSA and CE Pollution Degree 2 Altitude Up to 2 00...

Страница 27: ... 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 r 16 X 100 mm tube cassette for t 16 X 100 mm specimen tubes t IMMUNO TROL control tube in its special cassette adaptor Be sure to label each cassette with the correct bar code label r 16 X 75 mm tube cassette for t 16 X 75 mm tubes...

Страница 28: ...on The descriptions below are approved configurations Contact your Beckman Coulter Representative on current configuration availability Computer Intel Pentium 4 microprocessor and 256 MB SDRAM Data Storage r Removable and recordable media drive r 40 GB or larger nonremovable hard disk r 52X or higher CD ROM drive MPC II compatible Interfaces r Windows 2000 SP4 r Bidirectional asynchronous serial i...

Страница 29: ...hed Note The performance characteristics stated in the specifications were not established by any in vitro diagnostic assays It is the responsibility of each laboratory to verify that the system works for its applications Reagent Volume µL Precision CV Accuracy of volume IMMUNOPREP A 600 5 5 IMMUNOPREP B 265 5 5 IMMUNOPREP C 100 5 5 Dispense Volume µL Accuracy g of water Precision CV 1000 0 950 1 ...

Страница 30: ...PN 623112BA 3 6 SPECIFICATIONS PERFORMANCE SPECIFICATIONS ...

Страница 31: ...PN 623112BA A 1 A ALOG SHEETS This appendix contains the following log sheets r Maintenance and Operational Checks Log r Reagent Log r Action Log Make photocopies as needed ...

Страница 32: ...PN 623112BA A 2 LOG SHEETS ...

Страница 33: ...23112BA A 3 LOG SHEETS A Instrument Serial No Laboratory Indicate Procedure Specimen Cap Pierce Counter Tech Date Tech Date Startup Clean Probe and Shutdown Tech Date MAINTENANCE AND OPERATIONAL CHECKS LOG ...

Страница 34: ...PN 623112BA A 4 LOG SHEETS ...

Страница 35: ...PN 623112BA A 5 LOG SHEETS A Instrument Serial No Laboratory Reagent Name Concentration Units If applicable Date Received Date Opened Lot Number Expiration Date Tech REAGENT LOG ...

Страница 36: ...PN 623112BA A 6 LOG SHEETS ...

Страница 37: ...PN 623112BA A 7 LOG SHEETS A Instrument Serial No Laboratory Date Condition Noted Tech Tech Date Action Taken ACTION LOG ...

Страница 38: ...PN 623112BA A 8 LOG SHEETS ...

Страница 39: ...in your laboratory must be trained to properly and consistently use your laboratory s procedures regarding electronic records and signatures B 2 INTEGRITY OF ELECTRONIC DATA The division of Beckman Coulter that produces the FP 1000 uses quality controlled validated development and manufacturing processes Beckman Coulter Inc is certified as ISO 9001 1994 and ISO 13485 compliant Passwords All user a...

Страница 40: ...P 1000 System software applications provide audit trails of user log on and log out activities The System software audit trail also documents various other activities These audit trails can be searched displayed and printed Note If you use a third party software application such as MS Excel or Adobe Acrobat you must have procedures that ensure the security of these electronic records and provide a...

Страница 41: ...OL control cells Controls and indicators Instrument controls are the mechanisms you use to communicate with the instrument Indicators are the mechanisms the instrument uses to communicate with you Cytometer The system component that analyzes the sample and contains the sheath fluid and cleaning agent bottles db Acronym for decibels dc Acronym for direct current Defaults Original settings for the i...

Страница 42: ...ility of an instrument to reproduce similar results when a sample is run repeatedly Precision shows the closeness of test results when repeated analyses of the same material are performed It is also known as reproducibility Contrast with Accuracy defined above Printer A system component that provides a printout of sample results and other information Quality control QC A comprehensive set of proce...

Страница 43: ...e 3 4 bottle waste See waste container box dialog xi buttons definition of GLOSSARY 1 C cable location audio 2 4 data 2 4 serial 2 4 carousel tubes 3 4 cassette sizes 3 3 category installation 3 2 CD ROM Operator Manuals ix CE 3 2 checklist training 2 5 cleaning agent definition GLOSSARY 1 description 1 3 click definition of GLOSSARY 1 coefficient of variation CV See CV communications 3 4 componen...

Страница 44: ...nstrument about your reference manual ix conventions used x using the manuals ix drain 2 3 drainage requirements 2 2 E electrical input special requirements for 2 2 electronic data integrity B 1 records B 1 signatures B 1 B 2 end user license agreement 1 Ethernet 3 4 Excel 21CFR Part 11 considerations B 2 extension cord CAUTION 2 2 F FDA B 1 fixing reagent 1 2 flow cell definition of GLOSSARY 1 fl...

Страница 45: ...rmation system 1 2 2 6 laser definition of GLOSSARY 2 level sense reagents 2 7 license agreement end user 1 liquid handling 3 2 LIS 1 2 2 6 definition of GLOSSARY 2 log action A 1 maintenance and operational checks A 1 reagent A 1 log sheets A 1 action log A 1 maintenance and operational checks log A 1 reagent log A 1 Lyse Ammonium Chloride 1 3 lysing reagent 1 2 solution Ammonium Chloride 1 3 IOT...

Страница 46: ...nd precision 3 5 and waste connections 2 3 description 1 2 fixing 1 2 IMMUNOPREP 1 2 log A 1 lysing 1 2 rinse fluid 1 3 stabilizing 1 2 types used 1 2 reagents level sense 2 7 reference manual information organization ix introduction to your manuals ix using the manual ix reproducibility precision definition of GLOSSARY 2 requirements instrument accessibility 2 1 power 3 2 space needed 2 1 Researc...

Страница 47: ...roughput 3 4 tools support for 21CFR Part 11 B 1 training checklist 2 5 tube size daughter 3 4 specimen 3 3 tubing connections 2 3 U UI 1 2 UL 3 2 unpacking of instrument 2 1 USB ports 3 4 user access B 2 V ventilation requirements 2 1 VersaLyse Lysing Solution 1 3 voltages input 3 2 volume range liquid handling 3 2 W waste disposal 2 2 requirements 2 2 waste container capacity of 2 2 window dialo...

Страница 48: ...PN 623112BA INDEX 6 INDEX ...

Страница 49: ...hat it is used on the computer hardware and in the operating system environment for which it was designed Should the media on which your software arrives prove defective Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product This is your sole remedy for any breech of warranty for this software Except as specifically noted above Beckman Coulter makes no war...

Страница 50: ......

Страница 51: ...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 ...

Страница 52: ...x s Instructions For Use PN 629357 System Overview Using Panel Definition Software Daily Routine Quality Control Running Samples Operation Principles 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 Estr dos Romeiros 220 Galpao G3 Km 38 5 06501 001 Sao Paulo SP Brasil CNPJ 42...

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