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Excell2280 Nov28 2007
Excell2280 Nov28 2007
Preface
Drew Scientific Inc. is pleased to present you the EXCELL 2280 analyzer and thanks you for choosing this
system for your laboratory needs. The EXCELL 2280 Analyzer User Manual, Part Number #M-EXCELL 2280US-OP is published in the United States by Drew Scientific, Inc. Neither the whole or any part of the information
contained herein may be adapted or reproduced in any material form except with the prior written approval of
Drew Scientific, Inc.
All information of a technical nature and particulars of the EXCELL 2280 Analyzer and its use are given by Drew
Scientific Inc. in good faith, but may contains errors. This manual is intended only to assist the user in the use of
the EXCELL 2280 Analyzer and therefore, Drew Scientific Inc. shall not be liable for any loss or damage
whatsoever arising from the use of any information, or particulars in any errors, or omission in this manual. This
manual will help in the installation setup, routine work use, and general maintenance of the EXCELL 2280. This
instrument is intended for professionally trained personnel only. Following instrument training, All USERS
MUST carefully follow written instructions before using the instrument, and adhere to the outlined Warnings,
Precaution, and BioHazards that are intended to protect themselves against injuries or instrument damage.
The following conventions are used throughout this manual and are placed on all EXCELL 2280 Models to alert
the user of health and safety information. These signs are referenced in relevant parts and are discussed in
more details in relevant chapters. Those placed on associated products and consumables are referenced in the
insert of the product itself.
BIOHAZARD
All samples should be considered biohazard (contaminated with pathogenic
organisms). Any replaceable component which comes in contact with
biological samples, including the sample probe, sensors, sensor module,
pump tubing, reagent probe and reagent module may contain contaminated
material. Treat all components, during use and disposal, as you would any
biohazard us material. Dispose of biohazardous waste materials in
accordance with local, state, or federal requirements.
For questions that are not answered or addressed in this manual, please contact your local representative or
DREW Scientific Inc., technical service.
EXCELL 2280
EXCELL 2280
EXCELL 2280
Email: productsusa@drew-scientific.com
http:// www.drew-scientific.com
REVISIONS
Revision
No
Date
Author
Software
Comments
A
B
C
N/A
N/A
6/4/07
8/01/07
9/01/07
AK
JV
AFH
AFH
AFH
V.1.0.0
V.1.0.0
V.1.0.0
V.1.0.0
V.1.1.0
First Revision
Second Revision
Modular/ Pictorial Update, Glossary Add.
Text/references/pictorial update; Table of
Contents Update.
EXCELL 2280
Additional information
DANGER
Misuse of electrical equipment may cause electrocution, burns, fire and other hazards.
Protective grounding is required. Plug the EXCELL 2280 into a supply outlet that has a ground
connection.
Ensure good access to the supply outlet to facilitate unplugging the EXCELL 2280 in case of an
emergency.
Do not place the power supply adapter on wet surfaces, or where it could fall into liquid. If the
power supply adapter becomes wet, unplug it before touching it.
Do not use the EXCELL 2280 if it is non functional, or if it has suffered any damage (damage to
the supply cord or its plug; damage caused by dropping the power supply adapter).
Do not let the power supply adapter or its flexible cord come into contact with surfaces that are too
hot to touch.
Do not place anything on top of the EXCELL 2280
Do not use the EXCELL 2280 where aerosol sprays are being used, or where oxygen is being
administered.
Do not use the EXCELL 2280 outdoors.
Always switch off the EXCELL 2280 and disconnect the power adaptor before dismounting any
part.
The EXCELL 2280 is an automated hematology analyzer for in vitro diagnostic use ONLY , in
clinical laboratories by authorized users.
Only human blood, animal or artificial control blood should be run.
Only the reagents mentioned in this manual are permitted for use.
The optimum performance can only be achieved if the cleaning and maintenance procedures are
carefully followed.
Because this instrument is in contact with blood specimens susceptible to carrying pathogens,
always wear a lab coat, non-powder latex gloves and a facemask when using this equipment. As
recommended by current good laboratory practices (cGLP), always wash hands and clean
workstation with disinfectant after each use.
Use only parts supplied by the Drew Scientific or its authorized distributor.
Basic safety precautions should always be taken. If the equipment is not used according to the
manufacturers instructions, the equipment may become impaired, the results obtained could be
inaccurate and the warranty could become invalid.
The treatment of waste, the disposal of parts and/or the complete instrument must be carried out in
compliance with all local regulations.
Any output or input connections (except the printer and the barcode reader supplied by Drew
Scientific) cannot be modified without the authorization of Drew Scientific or its representative.
Do not attempt to open the door located on the right side of the instrument when a hydraulic cycle
is in progress; doing so will lead to an immediate stop. Should this happen, shut the door and run a
Reset cycle.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the
FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
The user may find the following booklet, prepared by the Federal Communications Commission, helpful:
How to identify and Resolve Radio/TV Interference Problems. This booklet is available from the U.S. Government Printing Office,
Washington, D.C. 20402, Stock No. 004-000-00345-4.
Pursuant to Part 15.21 of the FCC Rules, any changes or modifications to this equipment not expressly approved by Drew Scientific
may cause, harmful interference and void the FCC authorization to operate this equipment.
on the product indicates that this product may not be treated as household waste. Instead it shall be handed to the applicable
The symbol
collection point for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly, you will help prevent
potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this
product. For more detailed information about recycling of this product, please contact your local city office or your distributor of this product.
Pursuant to EU Directive 2002/96/EC.
EXCELL 2280
TableofContents
INTRODUCTION......................................................................... 13
1.4.CALIBRATORSANDCONTROLS................................................................16
1.5. REAGENTHANDLINGANDSTORAGE
PRECAUTIONS...17
1.6. SUPPLEMENTARYDATA ...............................................................................17
1.7. DREWTECHNICALSUPPORT ......................................................................17
1.8. THISMANUALANDTRAINING.................................................................18
INSTALLATIONANDINITIALSETUP ................................. 23
2.1. GENERAL.............................................................................................................23
2.2. UNPACKING ......................................................................................................25
2.3. POSITIONINGTHEEXCELL2280 .................................................................25
2.3.1. GeneralEnvironment........................................................................................ 25
2.3.2. PowerRequirements ......................................................................................... 25
2.3.3. SpaceRequirements .......................................................................................... 25
2.4.1.
2.4.2.
2.4.3.
2.4.4.
2.4.5.
2.4.6.
2.4.7.
2.4.8.
2.4.9.
2.4.10.
EXCELL 2280
SupplyTubingAssemblies............................................................................... 26
UninterruptiblePowerSupply ........................................................................ 26
Computer ............................................................................................................ 26
ColorMonitor..................................................................................................... 27
Printer.................................................................................................................. 27
Keyboard............................................................................................................. 27
BarCodeWand(Optional)............................................................................... 27
Mouse .................................................................................................................. 27
LaptopSetup ...................................................................................................... 27
ExSam30AutoSampler(Optional)................................................................. 28
Copyright Drew Scientific, Inc. All Rights Reserved.
2.6. INITIALPOWERUP....212
2.6.1. PoweringuptheSystem ................................................................................... 212
2.6.2. DryStartup.. ....................................................................................................... 213
2.6.3.SampleInitiationSwitch................................................................................... 214
2.7. SOFTWARECONFIGURATION....................................................................215
2.8. AUXILIARYMENU............................................................................................215
2.8.1.
2.8.2.
2.8.3.
2.8.4.
2.8.5.
2.8.6.
2.8.7.
2.8.8.
EXSAM30(ADDENDUM) ..............................................................................226
SYSTEMPRINCIPLES................................................................. 33
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
GENERALSYSTEMDESIGN..........................................................................33
ELEMENTSOFIMPEDENCECELLCOUNTING ......................................33
CELLCOUNTINGANDSIZING(RBC,PLT)..............................................35
CELLCOUNTING(WBC).................................................................................310
WHITECELLDIFFERENTIAL ........................................................................310
HEMOGLOBIN(Hgb)DETERMINATION..................................................310
CALCULATEDPARAMETERDETERMINATION314
3.7.1.
3.7.2.
3.7.3.
3.7.4.
3.7.5.
3.7.6.
EXCELL 2280
SPECIFICATIONS........................................................................ 43
4.1. OPERATINGCHARACTERISTICS...............................................................43
4.2. SAMPLINGFEATURES....................................................................................44
4.3. PERFORMANCESPECIFICATIONS.............................................................45
4.4. COMPUTERHARDWARE...............................................................................45
4.5. SOFTWARECHARACTERISTICS.................................................................46
4.1.1. ParametersReported......................................................................................... 44
4.1.2. ScientificPrinciples............................................................................................ 44
4.2.1.
4.2.2.
4.2.3.
4.2.4.
4.4.1.
4.4.2.
4.4.3.
4.4.4.
VolumesRequiredforEachAnalysis ............................................................. 44
DilutionRatios ................................................................................................... 44
CellCountingApertureSize ............................................................................ 44
CycleTime .......................................................................................................... 45
Excell2280ProcessorandMemory................................................................. 45
Display ................................................................................................................ 45
Input/OutputSupport....................................................................................... 45
Printer.................................................................................................................. 46
4.5.1. OperatingSystems............................................................................................. 46
4.5.2. SoftwareFeatures .............................................................................................. 46
4.5.3. Alerts ................................................................................................................... 47
4.6.1.
4.6.2.
4.6.3.
4.6.4.
4.6.5.
4.6.6.
ReagentsandControlsRequired..................................................................... 48
PowerRequirements ......................................................................................... 48
OperatingEnvironment.................................................................................... 48
Dimensions ......................................................................................................... 48
Weight ................................................................................................................. 48
RegulatoryCompliance .................................................................................... 48
DAILYOPERATINGPROCEDURES....................................... 53
5.1. SUPPLIESANDACCESSORIES.....................................................................53
5.2. SPECIMENCOLLECTIONANDHANDLING ...........................................53
5.3. STARTUP .............................................................................................................54
5.3.1. SystemChecks.................................................................................................... 54
5.3.2. InstrumentStartup ............................................................................................ 54
EXCELL 2280
5.5. PERFORMINGDAILYQUALITYCONTROLCHECK.............................511
5.6. EXCELL2280OPERATINGMODES..............................................................513
DATAARCHIVEANDWORKLIST ..........................................................63
6.1. FILESYSTEMDESCRIPTION ........................................................................63
6.1.1.DataArchive ................................................................................................63
6.2. WORKLIST ..........................................................................................................63
6.2.1.Overview ...................................................................................................63
6.2.2. WorklistMenu ................................................................................................... 64
6.2.3. DirectPatientWorklistON.............................................................................. 65
6.3.2. AutoSamplerModewithWorklist,withBarcodeReader .......................... 610
6.3.3.ExSam30withBarcodeReader ...................................................................... 611
6.3.4. RunningaStatsampleinAutoSamplerMode,
Instrumentnotbusy .......................................................................................... 611
6.3.5. RunningaStatsampleinAutoSamplerMode,
Instrumentisbusy ............................................................................................. 611
6.3.6. RunningSampleAnalysiswithanASTM
BiDirectionalLIS(HostQuery) ...................................................................... 612
6.3.7.UnsampledWorklist ........................................................................................ 614
6.3.8.DeleteWorklist ................................................................................................... 615
6.3.9.ReRunWorklist ................................................................................................. 616
EXCELL 2280
DATALOG ...................................................................................................................71
7.1. GENERALOVERVIEW.....................................................................................71
7.2. ACCESSINGTHEDATALOG ........................................................................71
7.3. SEARCHINGTHEDATALOG .......................................................................72
7.3.1. SearchbySequenceNumber............................................................................ 75
7.3.2. DisplayingResults............................................................................................. 77
7.3.3. ChangePatientDemographicalInformation................................................. 77
7.3.4.TransferringData ............................................................................................... 79
7.3.5.PrintingData....................................................................................................... 79
(a)PrintListingbySequenceNumber ......................................................... 79
(b)PrintResultbySequenceNumber .......................................................... 79
(c)PrintListingbyName............................................................................... 710
(d)PrintListingbyIDNumber .................................................................... 711
(e)DailyListingPrintout ............................................................................... 711
(f)ResultDailyPrintout................................................................................ 711
(g)StatsON/OFF............................................................................................. 711
CALIBRATIONPROCEDURES .................................................................83
8.1. GENERAL.............................................................................................................83
8.2. WHENTOCALIBRATE....................................................................................83
8.3. HOWTOCALIBRATE ......................................................................................84
QUALITYCONTROL(QC) ............................................................................93
9.1.
9.2.
9.3.
9.4.
GENERAL.............................................................................................................94
QUALITYCONTROLSYSTEMORGANIZATION ...................................94
SELECTIONOFACTIVECONTROLLOT ..................................................94
ADDINGCONTROLSTOTHESYSTEM ....................................................95
9.5. DELETINGACONTROLLOT........................................................................98
9.6. EDITINGACONTROLLOT ...........................................................................98
9.7. REVIEWINGQUALITYCONTROLRESULTS...........................................99
EXCELL 2280
OPERATIONALHAZARDS,PRECAUTIONSANDLIMITATIONS
10.1. GENERAL.............................................................................................................10-3
10.2.ELECTRICALHAZARDS .................................................................................103
10.3.INSTRUMENTPRECAUTIONS .....................................................................103
10.4.REAGENTPRECAUTIONS .............................................................................103
10.5.MAINTENANCEPRECAUTIONS .................................................................104
10.6.CALIBRATIONPRECAUTIONS....................................................................104
10.7.PROCEDURALPRECAUTIONSANDLIMITATIONS ............................104
10.8.GENERALRESULTSLIMITATIONS............................................................105
10.8.1. EXCELL2280FunctionalAlerts ...................................................................... 106
10.8.2. EXCELL2280SystemAlerts ............................................................................ 106
10.8.3. EXCELL2280HematologyFlags..................................................................... 108
10.8.4. LimitationsoftheHctDetermination............................................................. 1011
10.8.5. LimitationsoftheRBCCount .......................................................................... 1011
10.8.6. LimitationsofthePlateletCount..................................................................... 1011
MAINTENANCE.....................................................................................................113
11.1 GENERAL.............................................................................................................114
11.2 MAINTENANCELOG ......................................................................................114
EXCELL 2280
11.5 MONTHLYORPRECALIBRATIONCLEANING.....................................118
11.5.1 CleaningtheSlideValveandRinseBlock ..................................................... 1112
11.5.2 CleaningtheWBCAperture(NoDisassembly)............................................ 1112
11.5.3.ApertureDisassembly ....................................................................................... 1115
11.9 SYSTEMLOG......................................................................................................1120
TROUBLESHOOTING ......................................................................................123
12.1.GENERAL.............................................................................................................123
12.2.OVERVIEWOFTROUBLESHOOTING .......................................................123
12.2.1. UnderstandingTOF........................................................................................... 124
12.3.SEQUENCEOFOPERATION..........................................................................125
12.4.ALERTORSYMPTOM .....................................................................................125
EXCELL 2280
Drew Scientific, Inc.
Drew Scientific Co. Limited
4230 Shilling Way, Dallas, TX
Peter Green Way #4 , Barrow in Furness
75237-1023
Cumbria LA14 2PE , UK
(214) 210-4900 or (800) 433-0945
(Tel) +44 1229 432089 (Fax) +44 1229 432096
Fax (214) 210-4949
Email: productsusa@drew-scientific.com
http://www.drew-scientific.com
APPENDIXASYMBOLS .........................................................A1
APPENDIXBBIBLIOGRAPHY...............................................B1
APPENDIXCMATERIALSAFETYDATASHEETS .........C1
APPENDIXDGLOSSARYOFTERMS.................................D1
APPENDIXESUGGESTEDFORMS.....................................E1
APPENDIXFMENUFLOWDIAGRAMS.............................F1
MainMenu....................................................................................................................1
MainMenuTree...........................................................................................................2
StartupandShutdownMenus ..................................................................................3
WorklistMenuFindPatientbyIDNumber...................................................................... 4
WorklistMenuFindPatientbyName ................................................................................ 5
WorklistMenuRevisePatient.............................................................................................. 6
WorklistMenuDeleteHighlighted..................................................................................... 7
WorklistMenuAddSampletoCarousel1,2or3............................................................. 8
WorklistMenuUnsampledWorklist.................................................................................. 9
WorklistMenuDelete............................................................................................................ 10
WorklistMenuRerun............................................................................................................. 11
RunMenuRunBackground ................................................................................................. 12
RunMenuRunQualityControlSample............................................................................ 13
RunMenuRunPatientSample............................................................................................ 14
DatalogFindPatientbySequenceNumber....................................................................... 15
DatalogFindPatientbyIDNumber ................................................................................... 16
DatalogFindPatientbyName ............................................................................................. 17
DatalogChangePatientDemographics .............................................................................. 18
DatalogAcceptorRejectSamplefromDatalog ................................................................ 19
DatalogTransmitResultstoLaboratoryInformationSystem........................................ 20
DatalogPrintaListofSamplesbyUsingtheSequenceNumber ................................. 21
DatalogPrintResultsbyUsingtheSequenceNumber................................................... 22
DatalogPrintaListofSamplesUsingthePatientName................................................ 23
DatalogPrintPatientSampleResultsbyUsingtheIDNumber................................... 24
DatalogPrintListofTodaysResults,PrintTodaysResults ......................................... 25
DatalogTurnSTATSOn/Off ............................................................................................... 26
EXCELL 2280
CalibrationViewCalibrationMenu .................................................................................... 27
CalibrationAutoCalibrationMenus .................................................................................. 28
CalibrationManualCalibration ........................................................................................... 29
CalibrationSelectCalibrationModeSelectMCVorHCT............................................. 30
QualityControlSelectControlLotNumberforUsage ................................................... 31
QualityControlManuallyAddingaControlLotNumber............................................. 32
QualityControlDeleteaQualityControlLotNumber................................................... 33
QualityControlEditaQualityControlLotNumber ....................................................... 34
QualityControlLevyJenningsCharts................................................................................ 35
QualityControlQualityControlDataMenus................................................................... 36
QualityControlXBGraphs,ToggleXBOfforON .......................................................... 37
QualityControlXBTargetValues,XBSamples,XBBatches. ........................................ 38
MaintenanceMenuMaintenanceLog................................................................................. 39
MaintenanceMenuPrintMaintenanceLog ...................................................................... 40
MaintenanceMenuReagentMenus.................................................................................... 41
MaintenanceMenuPreventativeMaintenanceBleachWBC......................................... 42
MaintenanceMenuPreventativeMaintenanceCleanSlideValve .............................. 43
MaintenanceMenuPreventativeMaintenanceDismountApertures.......................... 44
MaintenanceMenuAdvancedMaintenance ..................................................................... 45
MaintenanceMenuSampleStatus ...................................................................................... 46
AuxiliaryMenuSetPatientRangesandActionLimits ................................................. 47
AuxiliaryMenuPrinters ........................................................................................................ 48
AuxiliaryMenuSetTransmittoLaboratoryInformationSystemSettings. ............ 49
AuxiliaryMenuDate,Time,andRegionalSettings ........................................................ 50
AuxiliaryMenuCustomizeReport...................................................................................... 51
AuxiliaryMenuWakeUpMenu.......................................................................................... 52
AuxiliaryMenuAdvancedSetupMenu............................................................................. 53
AuxiliaryMenuServiceMenu ............................................................................................. 54
EXCELL 2280