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
1
2
3
4
5
6
7
8
9
10
11
13
14
15
16
12

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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!

Instrument Specification and Installation Phadia 100 - User Manual
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ImmunoCAP Waste Container
ImmunoCAPWasteContainerislocatedonthelowerleftsideof
ImmunoCAP Carousel in the Processing Chamber. The instru-
ment will not indicate when the container is full.
NOTE! ImmunoCAP Waste Container has to be emptied after
every assay run.
WARNING! Waste bottle, ImmunoCAP waste
container and process chamber may be
contaminated by potentially infectious,
biohazard material - take appropriate actions.
Wear protective gloves!

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Technical Specification
Instrument Specification
Dimensions Width: 680 mm
Depth:600mm
Height: 440 mm
Weight Instrument:46kg
Total Weight (packaged): 86 kg
Mains Power Supply AC 100 V, 50/60 Hz
AC 120 V, 50/60 Hz
AC 230 V, 50/60 Hz
AC 240 V, 50/60 Hz
Main voltage tolerances +10% / -15%
Main frequency tolerances ±1%
Designedforcontinuousoperation
NOTE!ImmunoCAP100mustbeconnected
toagrounded poweroutlet(protective
ground).
Power 550VA
PrimaryFuses 100/120V T 5 A L
230/240V T 2.5 A L
NOTE! At time of delivery no primary fuses
are inserted. The main voltage selector is set
to 230 V.
Secondary Fuses F903 T 1 A L
F904 T 100 mA L
F905 T 63 mA L
F906 T 6.3 A L
F907 T 2.5 A L
F908 T 5 A L
F909 T 63 mA L
Capacity 48 samples loaded at the same time and
processed in each batch
Features Automateddispensing
Automatedprocessing
Automatedmeasuring

Instrument Specification and Installation Phadia 100 - User Manual
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Working Conditions Ambienttemperature:18ºCto32ºC
Ambient air humidity: 10% to 85% RH
Ambient air pressure: 860 hPa to 1060 hPa
Ambienttemperaturechange:2ºC/hour
(max.)
Heat Contribution 310 W (average) 1058 Btu/h
Storage Conditions Ambienttemperature:-20ºCto+70ºC
Ambient air humidity: 10% to 95% RH
Ambient Sound Level 57dBA
Warm-Up Time For normal assay: 1 hour
Interface ImmunoCAP 100 equipped with USB ports:
Two USB 2.0 type A ports are located at the
upperrightof theinstrumentand twoUSB2.0
typeAportsarelocatedattheinstrumentrear.
The USB ports can be used to connect USB
memorys or external USB harddrives.
One TCP/IP connector is located at the upper
right of the instrument rear. The TCP/IP
connector can be used for connection to IDM
(PhadiaInformationDataManager).
Oneserialport(COM2)islocatedattheupper
left of the instrument rear. (COM 1 is used
internally in the instrument.) This connection
will handle serial data communication in
accordance with the RS 232 C standard. The
COM2port canbeusedto connectabar code
reader.
Pincharacteristics(pinno.,name,output/input,
maximum voltage).
Pin 3 Tx output ±12 V
Pin 2 Rx input ±12 V
Pin 7 RTS output ±12 V
Pin 8 CTS input ±12 V
Pin 6 DSR input ±12 V
Pin 4 DTR output ±12 V
Pin 5 GND signal ground
Pin 1 DCD input ±12 V
Pin 9 RI input ±12 V
The serial port must be connected only to
external equipment meeting the appropriate
EMC and electrical safety standards
(i.e., IEC 1010-1, IEC 601-1, IEC 950,
EN 61010-1, EN 60601-1, EN 60950 or
equivalentUL-standard)

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Volume
ImmunoCAP100 equippedwith diskettedrive:
The serial ports (COM 1, COM 2 and
COM3)arelocatedattheupperpartoftherear
side of the instrument. These connections will
handleserialdatacommunicationinaccordance
with the RS 232 C standard.
COM1,COM2andCOM3portscanbesetup
for three different kinds of usage.
1) Serial communication to an external
computer
2) Serial communication to chain
communication
3) Barcode reader
Pincharacteristics(pinno.,name,output/input,
maximum voltage).
Pin 3 Tx output ±12 V
Pin 2 Rx input ±12 V
Pin 7 RTS output ±12 V
Pin 8 CTS input ±12 V
Pin 6 DSR input ±12 V
Pin 4 DTR output ±12 V
Pin 5 GND signal ground
Pin 1 DCD input ±12 V
Pin 9 RI input ±12 V
These serial ports must be connected only to
externalequipmentmeetingtheappropriateEMC
and electrical safety standards
(i.e., IEC 1010-1, IEC 601-1, IEC 950,
EN 61010-1, EN 60601-1, EN 60950 or
equivalentUL-standard)
Liquid Containers Washing Solution bottle volume: 1 litre
Rinse Solution bottle volume: 1 litre
Waste bottle: 2 litres
Rinse Solution Purified water. For references, see
DirectionsforUseforWashingSolution
(10-9422-01,10-9202-01).
Washing Solution Purifiedwater,WashingSolutionConcentrate,
Washing Solution Additive
Accuracy Pipette 40 µl: 50 µl: 90 µl: 200µl:
±0.5µl ±0.5µl ±0.9µl ±2 µl (meanvalue)
Washing Solution 137.5 µl ±7.5 µl (mean value)
Accuracy

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ElectricalSafety Phadia 100 complies with the following
directive and standards:
- Low Voltage Directive 73/23/EEC
- In Vitro Diagnostics Directive 98/79/EC
ElectricalSafety UniCAP®100
Standards used:
EN 60601-1: 1990, amendments A1, A11
and A12: 1993, pr A2 and pr A13: 1995
(IEC 601-1, second edition, 1988,
amendment 1, 1991, and amendment 2,
1995)andEN61010-1:1993and pr A2:
1995(IEC1010-1,firstedition,1990,
amendment 1, 1992, and amendment 2,
1995)
Phadia100/ImmunoCAP100E
Standards used:
IEC 61010-1:2001 (EN 61010-1:2001)
IEC 61010-2-081:2001 and A 1
(EN61010-2-081:2002)
IEC 61010-2-101:2002
(EN61010-2-101:2002)
ElectroMagnetic UniCAP®100
EN61000-6-3(2006)Genericemmission
standard for residential, commercial and
light industrial environments.
EN61000-6-2(2006)Genericimmunity
standardforindustrialenvironments.
EN61326(1997)withamendment61326/A1
and61326/A2
Phadia100/ImmunoCAP100E
EN61326:2004Genericemmissionstandard
for residential, commercial and light
industrialenvironments.
EN61326:2004Genericimmunitystandard
forindustrialenvironments.
Service It is very important to maintain Phadia100
regularly as described in chapter 11,
Maintenance. Negligence of the maintenance
leads to Processing Errors as well as Assay
Result Errors. Problems can occur which have
tobesolvedbyanauthorizedPhadiaABservice
technician.BeforehandingoverPhadia100for
service, it must be cleaned with Maintenance
Solution kit. Please follow the Directions for
Use in Maintenance Solution kit.
Classification
Compatibility

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Training All necessary information about installation
andhowtooperatePhadia100safelyisincluded
in the shipment. However, if you feel that
additional training is required please contact
your local Phadia AB representative.
Solid Phase Specification
ImmunoCAP
ImmunoCAPareflexiblehydrophilicpolymercarriersencased
in a capsule. The carrier consists of an activated cellulose
derivative.
Allergen ImmunoCAP carriers, each containing 16 or 10
ImmunoCAP, or packaged as 6 carriers, are separately avail-
abletopermitindividualselectionofthemostsuitableallergen
panel.
WhenhandlingImmunoCAP,keep thecarrierclosedtoavoid
evaporation of buffer. Do not leave the carrier open for more
than 1 day at room temperature. Otherwise, discard the first
ImmunoCAP.
EliAWell
EliA Wells are Polystyrene Wells coated with antigens or
antibodies.
The wells are packed in carriers, which are additionally stored
in sealed aluminum foilbags with desiccant.
After dispensing EliA Wells, always store the carriers in the
foilbags, which must beproperlyresealedforstabilityreasons.
Theindicatoronthedesiccantinthefoilbagshouldalwayshave
a blue color.
NOTE! For stability reasons it is important to
store ImmunoCAP and EliA Wells at 2° C to 8° C.
EliA Wells are moisture sensitive and must be
stored with desiccant.

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Operational Precautions and Limitations
ThiswarninglabelislocatedbelowthePipette
Arm.Thereisariskofskindamagebecausethe
pipette,whichcarrieshumanbodyliquids,may
movewithoutwarning.Please,keepyourhands
out of pipette range.
This warning label is to be placed to the left of
andontherighthandsideofthesamplecarousel
compartment (see Installation Instructions).
When handling human blood, be aware that
there is a biological risk involved.
Thiswarning label is to be placed on the waste
bottle(seeInstallationInstructions).Phadia100
waste bottle collects waste liquids containing
human body fluids, which might be infected.
When emptying and cleaning the waste bottle,
takeprecautionstoavoiddirectcontactwiththe
liquids. Wear protective gloves.
To ensure the minimizing of disposal of Waste
from Electrical and Electronic Equipment
(WEEE), this label is placed on the Rear Panel
oftheinstrument,accordingtothestandardfor
markingofelectricalandelectronic equipment
in accordance with Article 11(2) of Directive
2002/96/EC(WEEE),EN50419.(Thisapplies
within EU countries, Switzerland and Norway
since August 2005.) For disposal of the
instrument, please contact your local Phadia
representative.
Thislabelisacontaminationrestraintmarking
only applicable in the People's Republic of
China. It is placed on the Rear Panel of the
instrument.

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ThislabelguaranteesthatPhadia100complies
withelectricalsafetystandardsusedintheUSA
andCanada.ItisplacedontheRearPanelofthe
instrument.
Limitationsof Up to four conjugates can be placed in the
SampleCarousel.Thismeansthatthemaximum
numberofmethodsthatcan berunatthesame
time is four. EliA methods can not be used
togetherwithImmunoCAPmethods.
Precaution Phadia 100 is intended for in vitro diagnostic
testing, using reagents of Phadia only. When
operating Phadia 100, reagents manufactured
from human blood components are frequently
used.Thesourcematerialshavebeentestedby
immunoassay for hepatitis B surface antigen
andforantibodiestoHIV1,HIV2andhepatitis
C and found to be negative. Nevertheless, all
recommendedprecautionsforhandlingofblood
derivatives should be observed. Please refer to
HHSpublicationNo.(CDC)93-8395orlocal/
national guidelines on laboratory safety
procedures.
the Procedure

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Installation
Accessory box
Spacing collars
Manual box
Save the empty box!
This box is designed and manufactured for this
instrument only and should be used in future
transportation. Save the metallic clips, the
screws and the spacers!
NOTE! Do not unpack until the instrument has reached room temperature. If
major temperature differences exist (~10ºC), condensation will occur in the
instrument.
1. Removethemetallicclips
at the top of the plywood box
with a screwdriver. Save the
metallic clips.
2. Lift the cover of the ply-
wood box and place it beside
the instrument. If wanted lift
theplywoodboxstraightfrom
the wooden bottom plate and
place it beside the instrument.
3. Remove the four spacing
collars that are placed around
theinstrument.
4. Forfurtherinformationsee
theInstallationInstructions.

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Contents
Phadia100isdeliveredinoneboxcontainingtheinstrumentand theaccessory
box.Thecontentsintheaccessoryboxshouldbeaccordingtothefollowinglist.
AccessoryBox
The following accessories are included: Quantity
Mainskit100/120V 1
Mainskit230/240V 1
Printerpaper(tworolls) 1
ImmunoCAPHolderDisc 1
Elution Wells Disc 1
Sample Carousel 1
ImmunoCAPWasteContainer 1
Labels kit 1
Fusekit 1
Plastic bag 1
Allen key 1
Wrench 1
Feet 4
Media 1
containing
Phadia 100 User Manual
AshortintroductionfoPhadia100
How to run an assay in Phadia 100