Thermo Scientific Phadia 100 User manual

Phadia®100
English
12-3501-20/12
User Manual

This User Manual is intended to be a convenient source of product informa-
tionfortheuserofthePhadia100instrument.Furtherinformationisfoundin
the Directions for Use for the various reagent products and in the manuals for
theoptionalsoftware.
Information in this document is subject to change without notice.
All pictures displayed in this manual should be regarded as examples only.
This User Manual is not country specific and therefore reference may be
made to methods and/or assays that are not registered or cleared for use in a
specific country. Please consult your local sales office for country specific
information regarding the regulatory status of particular assays or methods
on Phadia 100.
The following designations are trademarks belonging to Thermo Fisher
Scientific Inc and its subsidiaries:
Elia, ImmunoCAP, Phadia, Phadiatop, Quality Club, UniCAP.
Trade mark change
Phadia AB has changed the trademarks of the instrument platforms from
"UniCAP®"and"ImmunoCAP®" to"Phadia®".Thenew namehasbeen
applied to the instruments and related items, e.g. Software and User Manu-
als. The trademark "ImmunoCAP®" has been removed from the System
Reagents. This is a trademark change only; the change has no impact on
performanceorsafety.
Embedded third party software: The Phadia 100 instrument may contain
third party software, e.g. third party software from Microsoft. The third
party software is subject to end user license terms of the respective software,
which the user must accept before any use of the Phadia 100 instrument. The
third party software is provided only for use in accordance with these end
user license terms. Any other use of the third party software is strictly
prohibited. Furthermore, the user may not install any additional software to
the Phadia 100 instrument without the prior written approval of Phadia AB.
Phadia 100 User Manual, version 12. This version is valid for Phadia 100
InstrumentVersion1.0andPhadia 100InstrumentSoftware Version3.0.
© 2012 Thermo Fisher Scientific Inc and its subsidiaries. All rights reserved.
Manufacturer: Phadia AB,
Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden.
IssuedOctober1995.RevisedMay2012.
ArtNo.12-3501-20/12

1. Instrument Specification and Installation
2. Routine Assay Run
3. Reagent and Sample Handling
4. Assay Run Editing Functions
5. Assay Run Data Evaluation
6. Assay Run Quality Control
7. Monthly Calibration
8. Quality Assurance
9. Methods, Test Panels, Article Management
10. Printouts
11. Maintenance
12. Error Handling
13. Repacking
14. Accessories
15. Index
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Chapter 1 - Instrument Specification and
Installation
This chapter describes technical
specifications and installation procedure
Instrument 2
IntendedUse 2
Principalfunctionality 2
InstrumentGuide 3
Sample Carousel 5
InstrumentLifting Points 5
ImmunoCAP/EliA Well Dispenser 6
USB ports/Diskette Drive 6
TCP/IPconnector 6
WashingSolution,RinseSolutionandWasteBottles 7
ImmunoCAPCarousel 7
ImmunoCAPWaste Container 8
TechnicalSpecification 9
InstrumentSpecification 9
SolidPhaseSpecification 13
OperationalPrecautionsandLimitations 14
Installation 16
Contents 17
InstallationInstructions 18
ParameterSetUp 22
Date/Time 22
Language 23
DefaultMethod 23
SetsIgEMethod 24
Contrast 24
Setand ChangePasswords 25
CommunicationParameters 26
ConfigurePhadia100forTCP/IP 27
Configurecomputername 28

Instrument Specification and Installation Phadia 100 - User Manual
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Instrument
Intended Use
Phadia100
Phadia 100 is a fully automated instrument including software to be used
togetherwithdedicatedin vitrodiagnostictests.The instrumentisdesignedto
handle processing of samples, reagents and measuring results and it can be
connectedtothesoftwarePhadiaInformationDataManager(IDM).Phadia100
is intended to be used in clinical laboratories.
Principal functionality
Phadia100is designedtobe usedtogetherwithImmunoCAPandEliAinvitro
diagnostic tests manufactured by Phadia AB. Phadia 100 yields the same
analytical results from samples of the same specimen as Phadia 250, Phadia
1000, Phadia 2500 and Phadia 5000 within stated tolerance limits. The
instrumentincludesfunctionsfor-distributionofsamples,ImmunoCAPandEliA
wells, and reagents,-processing of all assay steps for incubation and washing,-
reading of measuring values, calculations of analytical results, calculation of
statistics and result reporting.The algorithms included in the instrument
softwareusedfor calculationofanalyticalresultsandstatisticsare thesameas
the ones included in Phadia Information Data Manager (IDM).Up to five
instruments can be connected to an external computer and communicate with
IDMsoftware.WhentheinstrumentisconnectedtoIDMsoftwarethemeasuring
values are electronically transferred and calculations of analytical results,
calculation of statistics and result reporting is done by IDM software. Phadia
100 is designed to handle approximately 100 tests per working day.
SolidPhase
ForthemeasurementoftheantibodiesPhadia100canprocessImmunoCAPor
EliAWells.AllproceduresforEliAWellsshouldbeperformedasdescribedfor
ImmunoCAP.

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Instrument Guide
InstrumentFront
ImmunoCAP/
EliA Well Dispenser
Printer
Processing Lid/
Processing Chamber
Pipette Arm
Washing Solution,
Rinse Solution and
Waste Bottles
USB ports/
Diskette Drive
Keyboard
Sample Carousel
Cover
Sample
Carousel
Pipette
Display
ImmunoCAP/EliA Well
Waste Container
Processing Lid open
Processing Chamber
ImmunoCAP Carousel
Drainage filter
Wash Rake

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InstrumentRear
InstrumentequippedwithUSBports:
Instrumentequippedwithdiskettedrive:
COM 2 port
(COM 1 is used
internally in
the instrument)
Mains Power Inlet
Washing Solution,
Rinse Solution and
Waste Bottles
Cooling fan
Voltage selector
and Primary fuses
Power on/off
Secondary fuses
VGA connector
(for service only)
TCP/IP connector
USB ports
COM 3 COM 2 COM 1
Mains Power Inlet
Washing Solution,
Rinse Solution and
Waste Bottles
Cooling fan
Voltage selector
and Primary fuses
Power on/off
Secondary fuses

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Instrument Lifting Points
Lifttheinstrumentby holding undertheinstrument.Do not lifttheinstrument
by the areas indicated in the picture. Too much weight on these spots might
damagetheinstrument.
Sample Carousel
In the sample carousel you place the reagents
and samples in given positions. The positions
are:
1-48 Positions for calibrators, curve
controls,qualitycontrols, samples,
diluentanddilutiontubes
A-D PositionsforConjugate
E PositionforDevelopmentSolution
F PositionforFluoroC
G PositionforDiluent
H PositionforStopSolution
Please lift here!
Do not lift here!
Please lift here!

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ImmunoCAP/EliA Well
Dispenser
YouloadImmunoCAP/EliAWellcarriersinthe
ImmunoCAP/EliA Well Dispenser. The
ImmunoCAP/EliA Well Dispenser is placed on
top of the processing chamber. Push the cap
awayandpushthecarrierdownwardsuntilyou
feel it clicking into place.
YouwillbepromptedwhichImmunoCAP/EliA
Well carrier to load when you are in the Load
and Start mode. The instrument will
automatically place ImmunoCAP/EliA Well in
therightpositionin ImmunoCAPCarousel.
USB ports/Diskette Drive
Oninstrumentsequippedwith USBports,you
findtwoUSB2.0typeAportstotheupperright
oftheinstrumentandtwoUSB2.0typeAports
ontheinstrumentrear.Youcanstoredataona
USB memory or an external USB hard drive,
and use it in a computer. You can also import
data from a USB memory or an external USB
hard drive, to be used in the instrument. To
connect a barcode reader of USB type, please
contact your local Phadia representative.
Oninstrumentsequippedwithadiskettedrive,
youfindthediskettedrivetotheupperrightof
theinstrument.Youcanstoredataonadiskette
and use it in a computer. You can also import
data from a diskette to be used in the instru-
ment.
TCP/IP connector
Oninstrumentsequippedwith USBports,you
findaTCP/IPconnectortotheupperrightofthe
instrumentrear.TheTCP/IPconnectorcanbe
used for communication to an external com-
puterusingthesoftwareIDM(PhadiaInforma-
tion Data Manager).
TCP/IP connector

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ImmunoCAP
Holder Disc
Elution Wells
Disc
NOTE! Do not unscrew the cap from the bottles
ifthe tubingsarestill connected.Thiscan cause
problemswithinsufficientdistributionofWash-
ingandRinse Solution dueto twistedand stuck
tubingsinsidetheinstrument.
Washing Solution, Rinse Solution and
Waste Bottles
You find the Washing Solution, Rinse Solution
and waste bottles to the left of the instrument,
behindtheSampleCarousel.Whenyouconnect
thesebottlestotheinstrument,pleasebesureyou
connect them in the correct order. The bottles
andtubingsfromtheinstrumentaremarkedwith
differentcolourstoindicatethecorrectconnec-
tion.
Thereisaquick-releasefunctiononthetopofthe
nozzles.Pressthelittlebutton onthenozzleand
thetubingwillcomeoffimmediately.Whenyou
putthetubingbackonthebottle,pressthenozzle
on until you hear a clicking sound.
Fillthebottleswith1l of Washing Solutionand1lRinseSolutionfor one assay
run. When running ImmunoCAP Specific IgA, ImmunoCAP Specific IgG or
ImmunoCAPSpecificIgG4withafullsamplecarousel,1lofWashingSolution
is not enough. Fill up the bottle with Washing Solution.
We recommend that you prepare Washing Solution for a week's consumption
and use this to fill the instrument.
ImmunoCAP Carousel
ImmunoCAPCarouselisplacedintheprocessingchamber.You
find the processing chamber in the middle section of the
instrument. The chamber is opened by pressing the lid open
key. To open the lid, the power must be on. The lid cannot be
opened during processing. ImmunoCAP Carousel consists of
twounits,theElutionWellsDiscandImmunoCAPHolderDisc.
NOTE! ImmunoCAP Holder Disc is fragile and should be
handled as glass. Always replace if dropped on floor.
WARNING! Washing Solution may cause
sensitization by skin contact. Wear protective
gloves!