WADiana Compact Instrucciones de Utilización Instructions for Use
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3034072 Wadiana ES-EN cover:GRIFOLS 1/2/12 09:15 Página 1
Instrucciones de Utilización Instructions for Use
WADiana® Compact
Instrucciones de Utilización
Instructions for Use
WADiana® Compact
Diagnostic Grifols, S.A.
Passeig Fluvial, 24, 08150 Parets del Vallès, Barcelona - ESPAÑA (SPAIN) 3034072 12/2011
Tel. [34] 935 710 400 Fax [34] 935 731 132 www.grifols.com3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 49
WADiana® Compact
Instructions for use
Diagnostic Grifols, S.A. Passeig Fluvial, 24 - 08150 Parets del Vallès, ESPAÑA (SPAIN)3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 50
3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 51
PLEASE READ CAREFULLY THESE INSTRUCTIONS
BEFORE STARTING TO WORK WITH THE WADIANA® COMPACT
chapter 2 contents all the information referred to the equipment safety. e
symbols used in these instructions are:
NOTE:
Used for clarification and complementary or
emphasised information.
DANGER!
Any kind of injure –critical or not– for people,
that only can be diminished following the
instructions shown.
WARNING!
Any kind of injure for people, for which other
protection systems are provided, but it is
convenient the RESPONSIBLE AUTHORITY or the
OPERATOR knows it.
CAUTION!
Any kind of harmful situation for equipment or
others. This situation can be diminished using this
indication or with other protections.3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 52
Definitions:
RespOnsible AuThORiTy: Individual or group responsible for the use
and maintenance of equipment, and for ensuring that operators are
adequately trained.
OpeRATOR: Person operating equipment for its intended purpose. e
operator should have received appropriate training for this purpose.
QuAlifieD TeChniCiAn: Person responsible for the installation,
reparation and special maintenance of the equipment who has received
specific training for this purpose.
All restrictions referred to RESPONSIBLE AUThORITy are valid for
OPERATOR.
Equipment design and specifications are subjected to change without previous
notification.3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 53
WADiana® Compact Index
INDEX
1 IntroDuctIon ..............................................................................................1.1
1.1 INTENDED USE.......................................................................................................1.2
1.2 PURPOSE, LImITATIONS AND TRAINING
Of ThE DE OPERATORS WhO hAvE TO USE ThE EqUIPmENT ................................1.2
1.3 EqUIPmENT PARTS ................................................................................................1.3
2 safety InformatIon .................................................................................2.1
2.1 GENERAL INfORmATION ABOUT SAfETy ..............................................................2.1
2.2 EqUIPmENT mARKING ..........................................................................................2.3
2.2.1 Rating plate ....................................................................................................2.3
2.2.2 Label of biohazard and risk of injury with the probe ...............................2.4
2.2.3 Label sample carrousel .................................................................................2.4
2.2.4 Labels of the wash solution bottles .............................................................2.5
2.2.5 Labels of the waste bottle and the card disposal tray................................2.5
2.2.6 Equipment packaging label..........................................................................2.6
2.3 READ BEfORE USING .............................................................................................2.7
3 equIpment features .................................................................................3.1
3.1 TEchNIcAL SPEcIfIcATIONS .................................................................................3.1
3.1.1 Reagents and washing solutions..................................................................3.2
3.1.2 complementary accessories to WADiana System ....................................3.2
3.2 STANDARDS ThE EqUIPmENT cOmPLIES WITh USE ThE EqUIPmENT ...................3.2
4 equIpment functIons ..............................................................................4.1
4.1 DEScRIPTION Of ThE EqUIPmENT fUNcTIONS .....................................................4.1
4.1.1 Pipette system ................................................................................................4.1
4.1.2 centrifuge ......................................................................................................4.1
4.1.3 Image processing reader...............................................................................4.2
4.1.4 card transport system through each one of the various modules
in the equipment ...........................................................................................4.2
4.2 cOmmANDS AND cONTROLS ...............................................................................4.2
4.2.1 ON/Off switch .............................................................................................4.3
4.2.2 Doors ..............................................................................................................4.3
4.2.3 Indicator leds .................................................................................................4.5
4.2.4 manual opening ring ....................................................................................4.5
4.2.5 Other operations ...........................................................................................4.6
4.3 SySTEm SELf-chEcKS ............................................................................................4.7
4.4 BASIc ThEORy Of OPERATION...............................................................................4.8
i3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 54
WADiana® Compact Index
5 InstallatIon.................................................................................................5.1
5.1 AcTION DURING DELIvERy ...................................................................................5.1
5.2 INSTALLATION REqUIREmENTS..............................................................................5.1
5.3 cONNEcTION DIAGRAm ........................................................................................5.2
6 operatIng InstructIons ........................................................................6.1
6.1 PREPARATION BEfORE USE ....................................................................................6.1
6.1.1 checks and adjustments...............................................................................6.1
6.2 OPERATING PROcEDURE .......................................................................................6.2
6.2.1 Processes in which the operator intervenes ..............................................6.2
6.2.1.1 Selection of the test to be performed........................................................6.2
6.2.1.2 Introduction of samples..............................................................................6.3
6.2.1.3 Introduction of reagents and diluents......................................................6.4
6.2.1.4 Introduction of cards ..................................................................................6.5
6.2.2 Automatic processes .....................................................................................6.5
6.2.2.1 The equipment will check the entered load of samples,
reagents and cards .......................................................................................6.5
6.2.2.2 Pipette............................................................................................................6.6
6.2.2.3 Incubation.....................................................................................................6.6
6.2.2.4 Automatic transport....................................................................................6.6
6.2.2.5 The centrifuge of cards during the time determined
by the selected technique............................................................................6.6
6.2.2.6 The unloading of the cards one-by-one...................................................6.6
6.3 cLOSING PROcEDURE ............................................................................................6.7
6.3.1 Placing on stand-by.......................................................................................6.7
6.3.2 complete equipment stop ............................................................................6.7
6.3.3 Emergency stop .............................................................................................6.7
6.4 SPEcIAL PROcESSES ...............................................................................................6.7
7 maIntenance ................................................................................................7.1
7.1 mAINTENANcE PLAN ............................................................................................7.1
7.2 cLEANING AND DEcONTAmINATION INSTRUcTIONS ............................................7.2
7.2.1 cleaning instructions ...................................................................................7.2
7.2.2 Decontamination instructions ....................................................................7.3
8 transport anD storage .........................................................................8.1
8.1 EqUIPmENT STORAGE ..........................................................................................8.1
8.2 UNPAcKING ThE EqUIPmENT ..............................................................................8.1
8.3 PLAcING ThE EqUIPmENT IN ITS OPERATION POSITION ......................................8.2
9 equIpment DIsposal ..................................................................................9.1
10 Warranty.....................................................................................................10.1
maIntenance servIces carrIeD out .........................................................I
ii3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 55
WADiana® Compact Introduction
1 INTRODUCTION
THIS EQUIPMENT IS AN IN VITRO DIAGNOSTIC
MEDICAL DEVICE (IVD)
e WADiana® Compact is a Pc-controlled instrument that automates the
immuno- haematology techniques in gel.
e automatic procedures are:
• Positive sample identification: is identification is performed in
such a manner that, at all times, the results are ensured to be
correlated with the sample bar code label.
• Positive reagent identification. e reagents are diluents, red blood
cell reagents, anti-serum and enhance solutions.
• Positive card identification.
• card transport system among the various equipment modules.
• Sample dilution.
• Serum and/or plasma dispensing.
• Red blood cell suspension dispensing.
• Reagent dispensing.
• Incubation.
• centrifuging.
• Reading.
• Result interpretation.
ese instructions refer only and exclusively to the WADiana® Compact. Since
a Pc is needed for this operation, we refer to the soware but only by way of an
example. complete soware instructions are given in the Soware Manual,
which is included with the equipment.
1.13034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 56
WADiana® Compact Introduction
1.1 Intended use
is instrument has been designed for laboratories that perform test of
Immunohaematology, among others, to study donor/receptor compatibility in
blood transfusion and the diagnosis of maternal/fetal blood group
incompatibility.
e basis of all tests performed with this instrument is the reaction between the
haematic antigen and the antibody in the serum or reagent that produce and
agglutination of the red blood cells that can be detected in the filtration process
through the gel column.
e tests that can be performed are as follows:
• forward ABO group.
• Reverse ABO group.
• Antibody screening.
• Antibody identification.
• Rh phenotypes.
• Extensive phenotypes.
• Direct coombs.
• crossmatching tests.
1.2 Purpose, limitations and training of the operators who have to use
the equipment
e purpose of this instrument is to carry out immuno-haematological
techniques automating all operations sequence in order to:
• Increase process safety reducing possible errors in identification and
transcription.
• Increase analytical reliability standardizing all steps to reduce possible
handling errors and performing results interpretation with objective
criteria.
• Reduce dangers of OPERATOR contamination reducing OPERATOR
interaction with samples and reagents during the analytical process.
Limitations:
• e instrument is only prepared for performing immuno-
haematology tests and it is not possible to carry out other types of
tests different than those to which it is destined.
• e instrument can only use cards with gel microtubes.
1.23034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 57
WADiana® Compact Introduction
• Positive identification depends on the tubes, cards, diluents and
reagents being identified by bar codes. In order to guarantee the
maximum reliability in sample identification, the use of bar codes
with control digit (cheksum) is recommended.
• Doubtful or discrepant reactions should be validated by the
OPERATOR.
To use the WADiana® Compact, the OPERATOR should be trained to
laboratory technician level and have knowledge of immuno-haematology. e
OPERATOR should be familiar with the instrument’s automatic techniques,
possess a minimum Windows® user level and should be trained to use the
WADiana® Compact.
1.3 Equipment parts
Access to the equipment interior is done through a sliding door (1) and a moving
lid (2), (figure 1-1).
1
1:8
2
figure 1-1: Doors
Access to the instrument can only be done via soware. is means that it can
only be opened by pressing the ‘open’ button on the computer screen (the
soware and the instrument must be switched ON). Doing it, the upper door (1)
slides to the top and it is possible to open manually the lower door (2).
Once the door is open we can see the following parts (figure 1-2):
1.33034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 58
WADiana® Compact Introduction
• Sample carrousel. With capacity for 48 tubes having a diameter
between 10 and 15 mm (3)
• Reagent tray. With capacity for 16 reagents and 2 diluents (4)
• Working table. With capacity for 24 cards in two blocks of 16 and 8
cards (5,6)
• centrifuge for 12 cards (7)
• Service rack for 12 cards (8)
• Waste bottle (9), Wash Solution A bottle (10) and Wash Solution B
bottle (11). capacity: 4 litre each one.
• card disposal tray (12)
• Dilution station (13)
• Balancing card (14)
• Reader (15)
• Arm with a pipette probe and transport gripper (16)
• Digital pump (17)
• Rating plate (18)
• On/off switch and connections (19)
14 15
1
17
18
7
4
3 20 19
2 8
13 5 9 10 11 6 16 12
figure 1-2: parts identification
1.43034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 59
WADiana® Compact Safety information
2 SAFETY INFORMATION
2.1 General information about safety
e following indications have a direct involvement in the equipment safety:
DANGER!
Misuse of the equipment can impair the
protection provided by it.
WARNING!
To avoid the risk of electric shock, this equipment
must only be connected to electrical mains with
protective earth.
DANGER!
This equipment works with some substances that
carry a chemical or biological risk. The
established regulations for working in laboratories
in relation to the use of suitable gloves or other
personal protective means should be followed.
DANGER!
In the event of any spillage into the equipment, it
must be isolated from the electrical supply,
cleaned up and decontaminated. In any case the
instrument must be disassembled and the
equipment must not be reconnected until it has
been fully inspected by a QUALIFIED TECHNICIAN.
2.13034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 60
WADiana® Compact Safety information
WARNING!
Electromagnetic compatibility and electrical
safety tests have been performed using the cord
supplied by the manufacturer. However, if it is
necessary to use another cord, be sure that the
new cord meets the following specifications:
Cable type: flexible cable with insulation and PVC
cover with 3 conductors (neutral, live and earth).
Cord length: 2m
Conductor section: 1mm2 or higher
Connector type: For IEC inlet. Connector for class
I appliances.
Plug type: Plug type used in the country where
the equipment will be installed, with earth
connection.
Connector, cable and plug must comply electrical
safety requirements applicable in your country.
WARNING!
This equipment only must be used by
RESPONSIBLE AUTHORITY, OPERATORS and
QUALIFIED TECHNICIAN.
WARNING!
Basic safety precautions must always be taken,
including those indicated in 2.3 section "Read
before using". Furthermore, before installing the
instrument, the rules of 5.2 section "Installation
requirements" must be read.
2.23034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 61
WADiana® Compact Safety information
CAUTION!
Using cables other than those specified may
result in increased electromagnetic emissions
and/or decreased immunity of the equipment.
CAUTION!
The equipment should not be used adjacent to or
stacked with other equipment which are not
included in the system. If adjacent or stacked use
is necessary, the equipment should be observed
to verify normal operation in the configuration in
which it will be used.
2.2 Equipment marking
e labels used to provide information on the equipment are as follows:
2.2.1 Rating plate
is is located at the rear of the equipment next to the switch (figure 1-2)(18)).
It contains technical information about the equipment, such as serial number,
manufacturing date, model and name and address of the manufacturer.
2.33034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 62
WADiana® Compact Safety information
e following symbols are used:
year of manufacture
Serial number
medical product for in vitro diagnostics
e WADiana® analyzer meets the requirements of Directive
98/79/Ec.
Indicates that the WADiana ® analyzer is subject to selective waste
collection at the end of its useful life, as established by Directive
2002/96/Ec on Waste Electrical and Electronic Equipment. See
chapter 9 “EqUIPmENT DISPOSAL”.
2.2.2 Label of biohazard and risk of injury with the probe
is is located on the front face of the mobile arm where the probe is. is label,
composed of two symbols, is used to warn of the potential risk of infection and
the risk of injury caused by the probe if this area is approached.
figure 2-1: biohazard and risk of injury with the probe
2.2.3 Label of sample carrousel
is is located on the sample carrousel and provides information about the
sample number to which each carrousel location corresponds (figure 1-2 (3)).
2.43034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 63
WADiana® Compact Safety information
2.2.4 Labels of the wash solution bottles
ese labels are located on the front face and the cap of the wash solution bottles
(figure 1-2 (10) and (11)) and on the base where they are placed. ey are used
to identify content and place of each bottle.
figure 2-2: Wash solution a bottle label
figure 2-3: Wash solution b bottle label
2.2.5 Labels of the waste bottle and the card disposal tray
ey are located on the red cap and the front face of the waste bottle (figure 1-
2 (9)), and also on the front face of the card disposal tray (figure 1-2 (12)). ey
are used to warn on these recipients content, which is potentially infectious.
BIOHAZARD
RIESGO BIOLÓGICO
figure 2-4: biohazard label
2.53034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 64
WADiana® Compact Safety information
2.2.6 Equipment packaging label
e following symbols are used:
Serial number
catalogue number
Permitted temperature range during storage and transport
Permitted relative humidity range during storage and transport
medical product for in vitro diagnostics
e WADiana® Compact analyzer meets the requirements of
Directive 98/79/Ec.
2.63034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 65
WADiana® Compact Safety information
2.3 Read before using
Bear in mind the following remarks before using the equipment:
• Use the equipment only for the purpose described in the Instructions
for Use.
• Unless specified by the instructions for use, do not introduce or put
anything into any opening in the equipment.
• Do not use the equipment if it is not working properly, or if it has
suffered any damage. Examples of common defects include:
- Damage caused by fall of the equipment.
- Damage caused by liquid spillage.
- Damage caused by prolonged storage under unfavorable
conditions or by subjection to severe transport stresses.
- Damage to the flexible supply cord or its plug.
• Do not use the equipment in hazardous atmosphere, or with
hazardous materials for which the equipment has not been designed.
• Do not use accessories that are not supplied or recommended by the
manufacturer.
• for refilling the bottles, they must be taken away from the equipment,
previously.
• main fuses only must be replaced by a qUALIfIED TEchNIcIAN.
is instrument should only be disassembled by a qUALIfIED
TEchNIcIAN, either for internal cleaning and/or for repairing.
• Before disassembling the equipment must be unplugged.
• Do not introduce in the centrifuge flammable or explosive materials
or materials which chemically interact vigorously.
• Switch off the equipment aer use.
2-73034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 66
3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 67
WADiana® Compact Equipment features
3 EQUIPMENT FEATURES
3.1 Technical specifications
moDel: WADiana® Compact
supply: voltage: 100-120 / 220-240 v~
frequency: 50-60 hz
Input power: 300 W
fuses: 2 x T4A L 250v, 5x20 mm
protectIon agaInst
class: I
electrIc shocK:
InstallatIon Overvoltage category II (local levels, appliances,
category: portable equipment, etc.)
DImensIons (mm): 600 (depth) x 1000 (width) x 650 (height with closed
door)
WeIght (Kg): Approximately 87 kg
materIals: packaging: wood, ethafoam.
equipment: aluminium, stainless steel, iron,
polyurethane (expanded foam), glass, electronic
components (silicon, cupper...)...
operatIng Indoor use
conDItIons:
temperature: 15 ºc to 28 ºc
maximum relative 80%
humidity non
condensing:
minimum relative 30%
humidity non
condensing:
maximum altitude: 2000m.
mains supply ±10% of nominal voltage
maximum voltage
fluctuations:
3.13034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 68
WADiana® Compact Equipment features
transport temperature: -10 ºc to 60 ºc
anD storage
conDItIons: maximum relative
humidity non 85%
condensing:
centrIfuge: maximum load: 12 cards
bottles' WorKIng approx. 180 mbar (pressure)
pressure: < 300 mbar (vacuum)
computer requirements: controlled by Pc Pentium with 32 mb of RAm or
higher, with BUS SLOT PcI and parallel port LPT1. A minimum of one standard
serial RS-232c port is needed.
e WADiana® Compact has been designed and tested so that it complies with
all the necessary requirements of accuracy and reproducibility in the handling
of liquids, contamination, temperature stability and accuracy, precise mechanical
movements and all those parameters that might affect the specific tests for which
it has been designed.
Any other specifications are not guaranteed, especially in the case where the
equipment is used for functions other than the ones for which it has been
designed.
3.1.1 Reagents and washing solutions
e soware communicates the reagents and cards required for carrying out
the technique once it has been selected. moreover, Wash solution A and Wash
solution B must be used with the equipment.
3.1.2 Complementary accessories to WADiana System
As well as the previously mentioned Pc, the following complements may be used
with the system:
• A bar code reader for the identification of the samples, cards and tubes
in the specific operating situations (delivered with the equipment).
• A printer for obtaining a hard copy of the obtained results.
• Diana Bcc: bar code replicating printer.
3.2 Standards the equipment complies with use the equipment
e equipment conforms to the requirements of the Directive 98/97/Ec of the
European Parliament and of the council on “In vitro Diagnostic medical
Devices”
3.23034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 69
WADiana® Compact Equipment functions
4 EQUIPMENT FUNCTIONS
4.1 Description of the equipment functions
e WADiana® Compact functions are those described in the intended use
(chapter 1.1). In order to carry out these functions, the equipment incorporates
various parts:
1) Pipette system
2) centrifuge
3) Image processing reader
4) card transport system through each one of the various modules in
the equipment.
4.1.1 Pipette system
is consists of:
• Sample carrousel.
• Reagent and diluent carrousel.
• Working table.
• Dilution station.
is part of the equipment is based on a digital pump and a fluid system. e
pump sucks in and measures a suitable amount of sample and reagent according
to the test being performed. ese substances are carried through the fluid
system to the reagent card where they are applied via the sampling probe.
4.1.2 Centrifuge
is has been designed to centrifuge the reagent cards at the required speed and
for the necessary time required by each specified technique.
It precisely positions each one of the cavities in order to receive the cards from
the automatic transport system and thus avoiding any possible imbalances.
In a situation where the number of cards in the current batch does not permit
a balanced load, a supplementary card, reserved for such a purpose, will be used.
4.13034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 70
WADiana® Compact Equipment functions
WARNING!
This equipment element was not designed to be
manipulated in any way by the OPERATOR.
WARNING!
The centrifuge contained in this equipment must
not be used independently. It has been designed
to be automatically loaded and unloaded with the
materials described in this manual and must not
be used for any other purpose.
4.1.3 Image processing reader
is is based on a ccD camera and an image acquisition card located inside the
Pc. e objective is to take a photo of the reagent card in order to carry out later
morphological analysis, from which the result of the performed test will be
determined.
4.1.4 Card transport system through each one of the various modules in the
equipment
is consists of an arm that transports the cards through each one of the
equipment modules, and includes the pipette probe.
4.2 Command and controls
In this chapter we will identify all the points that are accessible to the
OPERATOR and their function within the equipment as a whole.
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WADiana® Compact Equipment functions
4.2.1 ON/OFF switch
1:8
MAINS CABLE CONNECTION
ON/OFF SWITCH
figure 4-1: on/off switch
It has two positions:
• O: off
• | : On
4.2.2 Doors
e WADiana® Compact has two doors on the equipment front face.
4.33034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 72
WADiana® Compact Equipment functions
1
1:8
2
figure 4-2: Doors
e upper door opens under soware control from the Pc. Behind it, there are
the whole transport system and all the equipment’s functional elements: the
sample and reagent carrousel, the centrifuge, incubators...
1:8
figure 4-3: Doors movement
4.43034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:30 Página 73
WADiana® Compact Equipment functions
e lower door opens by pulling it down in the direction of the arrow. however,
this is only possible if the upper door is already open. erefore WADiana®
Compact equipment can only be accessed when it is not operating in a way that
is potentially dangerous for the OPERATOR.
is lower door allows the access to the bottles for the wash and waste solutions,
as well as to the lower tray for collecting the used cards.
e bottles as well as the used card tray have been designed so that they may be
easily taken out.
e bottles for the wash and waste solutions as well as the used card collection
tray can be removed from the WADiana® Compact by pulling them. en they
may be filled or emptied as required.
4.2.3 Indicator leds
LED 1
LED 2
1:8
figure 4-4: Indicator leds
ere are two green indicator leds on the lower door. ese indicator leds
provide the following information:
• Led 1: indicates if the equipment is switched on or off.
• Led 2: indicates equipment access. It is on whenever the door may be
opened for accessing to the interior of the equipment.
4.2.4 Manual opening ring
is ring is located within a covered cavity and can be accessed by removing
the screw with a tool. is cover allows the front door to be opened in the
situation where the electronic opening system does not work.
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WADiana® Compact Equipment functions
WARNING!
Not usable by the OPERATOR nor the
RESPONSIBLE AUTHORITY, only for use by the
QUALIFIED TECHNICIAN.
4.2.5 Other operations
Other operations that require OPERATOR interaction are as follows:
• e sample carrousel: is consists of a 48-sample tube capacity
carrousel. It can be used with various sizes of tube without adapter
(10, 12 or 15 mm tubes).
• Reagent carrousel: It has capacity for 18 containers, two of which are
for diluents and the rest for reagents.
Both carrousels should only be removed for equipment maintenance or cleaning
purposes.
3
2
1
figure 4-5: card loading and unloading area
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WADiana® Compact Equipment functions
• card incubating blocks (figure 4-5 (1)): ere are two blocks
available that can be heated to two different temperatures: 24 °c or
7 ºc. ese are used to incubate the cards according to the
temperature and time that the technique being used requires.
• service rack (figure 4-5 (2)): is is where he equipment places the
cards that it has not been able to read correctly, the results of which
are doubtful. It is also the location for half-used cards that are not
discarded in case they can be used with the following batch.
• a rack for the card to be used in case of unbalance (figure 4-5 (3)):
is rack is used to hold the reserve card that is only used in the case
the centrifuge is not balanced once the batch of cards has been
loaded. In such a case the equipment will place the card in a suitable
position in the centrifuge so that it operates correctly.
• bar code reader: is reader is used for the identification of the
processed samples, of the cards to be used and of the reagents
corresponding to each technique in specific operating situations.
4.3 System self-checks
e WADiana® Compact equipment performs internal self-checks to ensure the
correct operation of all the controlled elements.
e following checks are carried out:
• When the WADiana soware is started, it will check that each one
of the electronic component responds.
• When the test to be carried out is selected, the following checks are
made:
- at there is a balancing card.
- at the service rack is empty.
- at there are no cards in the centrifuge.
en it continues to positively identify the cards, reagents, samples and wash
and waste solution levels.
In order to do this, the following steps are performed:
1) It locates and identifies the reagents and checks the ‘expiry date’ and
that the reagent level is sufficient.
2) It agitates the reagents to avoid sedimentation of the red blood cells.
3) It locates, identifies the bar code and detects the diameter of sample
tubes.
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WADiana® Compact Equipment functions
4) It checks that it has all the cards required for the selected test and
that they are of a suitable type, as well as the expiry date and lot.
4.4 Basic theory of operation
e WADiana® Compact is designed to reproduce as faithfully as possible the
following steps performed manually and described in the instructions for use of
the corresponding reagents for gel haematological tests:
• reagent filling
• sample filling
• sample red blood cell dilution
• incubation
• centrifuge
• results reading: it is based on morphological analysis performed
through image processing.
In addition to this, the WADiana® Compact performs the following procedures:
• process automation
• sample and reagent positive identification
• reading, interpretation and recording of results
• report issue
consult your distributor to obtain more information related to the tests and
reagents that are validated to be used with the WADiana® Compact.
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WADiana® Compact Installation
5 INSTALLATION
5.1 Action during delivery
is equipment shall always be installed by a qUALIfIED TEchNIcIAN.
e qUALIfIED TEchNIcIAN shall provide the OPERATOR with suitable
instructions for putting the equipment into operation.
When the equipment is received, it shall be checked to ensure it includes all the
modules as specified on the attached packing list. e section 8 “Transport and
Storage” instructions must be followed during the unpacking process.
5.2 Installation requirements
e requirements for the place where the equipment is to be installed are as
follows:
• Environmental conditions: see section 3.1 “Technical
specifications”
• Space requirements: The equipment occupies a horizontal surface
area of 60 cm. depth x 100 cm width (0.6 m2), however, a
minimum installation space of 80 cm depth x 120 cm width is
recommended.
• Do not place the equipment outdoors.
• Do not place the equipment on a surface of flammable material.
• Do not place the equipment where it is difficult to access for
maintenance or servicing.
• Do not place the equipment where it could get wet.
• Do not position the equipment so that it is difficult to operate the
mains disconnecting device.
• Do not let the equipment or its flexible cord come in contact with
surfaces that are too hot to touch.
• check that the plug outlet has an earth connection.
• check that the nominal voltage shown on the equipment matches
the supply voltage.
• Do not place anything on top of the equipment.
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WADiana® Compact Installation
5.3 Connection diagram
PC WADIANA CONNECTIONS
DETAIL A
15 PINS CONNECTOR
(VIDEO OUT CAMERAS)
9 PINS CONNECTOR (RS-232)
DETAIL A (PC/DG-57 COMMUNICATIONS)
figure 5-1: connections
9 PINS CONNECTOR (VIDEO IN)
figure 5-2: video card –WADiana® Compact connection
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WADiana® Compact Operating instructions
6 OPERATING INSTRUCTIONS
6.1 Preparation before use
6.1.1 Checks and adjustments
CAUTION!
Neither the RESPONSIBLE AUTHORITY nor the
OPERATOR are allowed to make any manipulation
in the software supplied with the WADiana®
Compact.
CAUTION!
To avoid possible software malfunction, it is
recommended:
1) Not installing any additional software and/or
hardware as far as the strictly required.
2) Disabling any screensaver and the Windows®
energy saving mode.
verify the WADiana is properly installed and the Pc with the operating system,
the WADiana Soware and the image treatment card are also installed. To
ensure that the equipment is under correct operating conditions, follow next
steps:
• check that the equipment is plugged into the electrical mains supply.
• check that the switch is in position I (ON) and that the green
indicator led (figure 4-4 (Led 1)) is lit.
• Enter the WADiana Soware by double clicking on the icon. At this
point the equipment will check system integrity and the
communications with the various components.
• Open the door using the soware.
• Open the lower li door and check that the wash and waste solution
bottles are present and correctly positioned, as well as that the waste
support tray is in a suitable position.
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WADiana® Compact Operating instructions
• Prepare wash solutions A and B according to the instructions for use
of the wash products (this step may be omitted if the solutions are
already prepared).
• check that the samples and reagents are present in the carrousel.
CAUTION!
The calibration and adjustments of the WADiana
Compact must be performed only by a QUALIFIED
TECHNICIAN.
6.2 Operating procedure
6.2.1 Processes in which the operator intervenes
We must follow these steps so that the WADiana® Compact is able to
automatically perform all the required processes for the selected technique with
the information we supply:
1) Selection of the test to be performed.
2) Introduction of samples.
3) Introduction of reagents and diluents.
4) Introduction of cards.
NOTE:
This order may be changed for experienced
OPERATORS.
e first thing to do once the equipment is switched on, is to open the front
door through the soware. en, batch preparation can take place.
6.2.1.1 Selection of the test to be performed
We can select any of the sowared immuno-haematological techniques via the
WADiana soware. Once the test has been selected, we can introduce the
samples, reagents and cards.
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WADiana® Compact Operating instructions
6.2.1.2 Introduction of samples
e tubes of samples to be processed are introduced consecutively from position
number one on the carrousel, turning the bar codes outwards.
To warranty the maximum safety in the sample identification, it is recommended
to use bar codes with control digit (checksum).
moreover, the OPERATOR must be sure that the tubes contain enough sample
(red blood cells and/or serum) to allow the pipetting process, being 250 µl the
minimum detectable quantity (volume).
Avoid bubbles in samples, especially if serum is transferred from primary tube
to another.
Avoid fibrin and clots in samples. Although they are detected by the system they
are not advisable, because they stop the process and could block the syringe
permanently.
CAUTION!
To the correct performance of the equipment, the
bar code labels must be well sticked on the
sample tube, and must not be written or
defective.
WARNING!
The use of hemolised or cloudy samples or with
clot or fibrin presence may lead to false positive
readings. Do not use such kind of samples with
the system.
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WADiana® Compact Operating instructions
NOTE:
There is an exception to this procedure, which is
crossmatching test. The protocol to be followed
when introducing the samples for crossmatching
tests is:
• The first tube corresponds to the receptor and
all the consecutive tubes from this one are
possible donors.
• One empty position in the carrousel will indicate
that the next tube is a new receptor, followed
by the samples to crossmatch. Two empty
positions are interpreted as the end of samples.
It is necessary to work with sedimented red blood
cell samples. If it is necessary, use centrifuged
samples.
All this shall be done in accordance with the
instructions provided by the WADiana software.
6.2.1.3 Introduction of reagents and diluents
e soware will automatically provide information about the type of reagents
and diluents to use according to the selected technique and amount of samples.
By default the Pc will indicate in which position each one of the reagents has to
go in case bar codes are not used.
When using the bar codes, it is not essential to locate them in specific positions
since the system is able to identify and locate each one of the reagents and
diluents present on the carrousel.
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WADiana® Compact Operating instructions
CAUTION!
To achieve a proper test execution, the reagents
must be resuspended and allowed to reach room
temperature when introduced, and the vials must
be completely dry and the barcode label in good
condition.
6.2.1.4 Introduction of cards
e soware will also provide the type, location and quantity of cards for
processing of the current batch that must be introduced into the WADiana®
Compact.
6.2.2 Automatic processes
Once all the necessary elements for processing the batch have been introduced,
the front door may be closed manually and when the soware detects this, the
automatic processing will begin according to the following sequence:
6.2.2.1 The equipment will check the entered load of samples, reagents and
cards
• It will identify all the introduced samples through their bar codes (if
they have not been manually identified).
• It will check that the bar codes of the reagents and diluents correspond
to those indicated by the technique, this means the ones that have
been introduced are those previously requested and not others (*).
• It will check the level of reagents and diluents to determine if there
is sufficient quantity to process the identified number of samples.
• Once the cards have been placed in position, the equipment will
identify them and check that they are the requested ones and that
there is the necessary quantity.
(*) ere is the possibility of loading all the necessary reagents at one time to
process more than one batch. In this situation, the equipment will locate and
identify them using only those required for the current batch.
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WADiana® Compact Operating instructions
6.2.2.2 Pipette
is includes the priming of the fluid system and the injection of each one of the
‘blocks’ that are sowared in the test, which may be combinations of:
• Dilutions (of sample red blood cells with the adequate diluent and
dispensing in the corresponding wells).
• Reagents (cell suspension dispensing).
• Serum (sample serum or plasma dispensing).
• Diluents (diluent or other reagent dispensing).
• Anti-serum (anti-serum dispensing in the appropriate wells).
6.2.2.3 Incubation (if applicable)
is consists of the transport of heat from the incubating block to the card
during the time and at the temperature determined by the technique (24 °c or
37 ºc).
6.2.2.4 Automatic transport of the cards from the incubator block to the
centrifuge
6.2.2.5 The centrifuge of the cards during the time determined by the
selected technique
e centrifuge balance is carried out automatically by the soware according to
the number of cards to centrifuge. e equipment is equipped with a balance
sensor in order to ensure this balance security.
6.2.2.6 The unloading of the cards one-by-one
Automatically carrying them to the reader, where the results are read prior to
discarding the cards or, according to the configuration, prior to returning the
cards to the incubating blocks in order to conserve them.
If there are doubtful cases, then the cards are taken to the service rack included
for this purpose for later re-checking.
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WADiana® Compact Operating instructions
WARNING!
WADiana® Compact results must be reviewed
and validated by qualified personnel.
6.3 Closing procedure
6.3.1 Placing on stand-by
e WADiana® Compact remains automatically on stand-by, once all the
samples have been processed when the automatic process is ended.
is stand-by situation can be identified by checking the soware’s main screen.
6.3.2 Complete equipment stop
In order to completely stop the equipment it is first necessary to exit the soware.
On leaving the soware there is the possibility of a final wash of the fluid system,
which has to be confirmed. To do so, the door must be closed. Once the door
has been closed, the final wash will be carried out.
e following step in order to disconnect functionally the equipment is to switch
off the main switch. en the front le LED turns off.
If you want to completely disconnect the equipment, disconnect the main cable.
6.3.3 Emergency stop
All the time, the screen will indicate the possibility of stopping the process via
the STOP button.
Once pressed, the process can be cancelled following the soware instructions,
which implies complete process interruption.
6.4 Special processes
e system provides the possibility of configuring an automatic discarding of the
cards or their conservation, which consists in returning the cards to the
incubating blocks for later manual extraction.
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WADiana® Compact Maintenance
7 MAINTENANCE
7.1 Maintenance plan
As a general rule whenever no kind of irregularity has occurred in the
equipment operation, the maintenance plan shall be as follows:
tIme actIvIty performeD
Aer each session final wash of the fluid circuit. responsIble
(daily) When daily work ends, the authorIty /
soware asks if a final wash is to operator
be carried out; the answer
should be “yes”.
Whenever samples Reagent and sample carrousel responsIble
or other substances cleaning as described in section: authorIty /
are spilled on the 7.2.1 “cleaning instructions” operator
carrousel.
Every month Equipment decontamination responsIble
described in section: 7.2.2 authorIty /
“Decontamination instructions” operator
Every twelve months check the general equipment qualIfIeD
condition (mechanical sample technIcIan
adaptors, throwaway tubes,
calibration etc)
maintenance operations carried out on the equipment shall be noted on the
record “maintenance services carried out” included at the end of the Instructions
manual.
Technical assistance can be provided by your supplier or other Diagnostic
Grifols' authorised services.
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WADiana® Compact Maintenance
7.2 Cleaning and decontamination instructions
DANGER!
During cleaning and decontamination processes,
protective gloves must be used by the OPERATOR.
WARNING!
The equipment surfaces, dilution station and
probe cleaning works, shall be carried out with
the equipment unplugged from the electric mains
supply.
CAUTION!
Before using any cleaning or decontamination
methods different than those recommended by the
manufacturer, the RESPONSIBLE AUTHORITY must
confirm with the manufacturer that the proposed
method will not damage the instrument.
7.2.1 Cleaning instructions
e WADiana® Compact has been manufactured with the best quality materials.
however, saline solutions and acid or alkaline solvents must be cleaned from
the exterior surfaces before they produce any damage.
e exterior surfaces should be periodically cleaned, but always with the
equipment completely disconnected from the electric mains supply. Use a damp
cloth with a mild detergent.
e carrousel may be removed in order to clean it. It should be cleaned with a
damp cloth and soap. Additionally, alcohol may be used to clean the area that has
been in contact with samples.
Additionally, with a cotton stick wet in distilled water, clean the higher side of the
probe wash station inserting the cotton stick into the window placed in the
frontal cover of the arm with the pipette probe. is windows is placed below the
label of figure 2-1.
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WADiana® Compact Maintenance
e wash and waste bottles should also be removed from the equipment in order
to be emptied and cleaned.
WARNING!
Take care of not leaking liquids into the
equipment openings.
WARNING!
The contents of the waste bottle should be
emptied into special containers provided for this
type of waste that must be eliminated in a
selective manner.
e external wash of bottles should also be carried out with soap and water.
NOTE:
The front glass should always be cleaned with
mild and not abrasive products, in order to avoid
any scratching of the glass during the cleaning
process.
7.2.2 Decontamination instructions
e decontamination process of the equipment should be carried out monthly
(see the maintenance plan) or whenever the equipment is moved from its
working area.
e decontamination process for the WADiana® Compact equipment is as
follows:
1) Dispose of following solutions:
- 3500 ml of 0.5% Sodium hypochlorite solution.
- 5000 ml of reagent grade water.
- 100 ml of 70% ethyl alcohol.
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WADiana® Compact Maintenance
2) fill the wash bottles A and B with the 0.5% Sodium hypochlorite
solution (1500 ml in each one). fill the waste bottle with 500 ml of
0.5% Sodium hypochlorite. Shake to decontaminate its inner.
3) Prime the system three times using the soware.
4) fill dilution station with 2.5 ml of 0.5% Sodium hypochlorite using
a pipette.
5) Wait 10 minutes.
6) Rinse and drain the bottles several times with reagent grade water in
order to eliminate any trace of Sodium hypochlorite.
7) fill wash bottles A and B with 1500 ml of reagent grade water each.
Select Rinse option on the program.
8) e equipment will automatically perform a 10 rinse cycles of the
entire hydraulic system using reagent grade water. Once they have
been finished, the program requests to drain solution from waste and
wash bottles and to replace for A and B solution. Select continue.
9) cleaning of dilutions station: clean the inner par of the dilutions
station, using a cotton stick wet with reagent grade water.
10) Switch the equipment off and unplug the electric mains cable. Probe
cleaning. follow next steps:
- move the arm until frontal le corner of the equipment.
- Drive manually the pinion placed in the higher part of the
arm, and low the probe until its maximum position.
- clean the probe external part with a cloth and 0.5% Sodium
hypochlorite solution.
- clean the probe external part with a cloth and reagent grade
water.
- Raise manually the probe until top position and turn back
once approximately.
11) clean the exterior of the equipment with a cloth and reagent grade
water. Decontaminate the exterior of the equipment with a cloth and
a solution of alcohol. is operation must be carried out when
dangerous substances are spilled on the equipment.
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WADiana® Compact Transport and storage
8 TRANSPORT AND STORAGE
8.1 Equipment storage
If the WADiana® Compact must be stored for a long period of time, it is
recommended to pack it as for transport.
e environmental storage conditions should be as specified in section 3.1
"Technical specifications"
e space requirements for storing the equipment are as follows: Size: 1200 mm
width x 750 mm depth x 920 mm height
Weight: (87 + 35) = 122 Kg
CAUTION!
Use only the original packing material for
transporting the equipment.
WARNING!
Take care of decontaminating the equipment
before being transported.
8.2 Unpacking the equipment
In order to unpack the equipment, remove the packing material according to the
following instructions:
1) Remove the wooden box, taking into account the screws that fix it
to the pallet.
2) Remove foam protections that protect the equipment.
8.3 Placing the equipment in its operation position
Before unpacking the WADiana® Compact, it should be placed on the floor with
the pallet, as close as possible to where it is to be installed.
here, it should be unpacked according to the instructions explained in the
previous section and then it should be placed in the chosen place.
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WADiana® Compact Transport and storage
Transporting the equipment requires various persons. hands will be inserted
into the handles located at the lower part of the sides.
Keeping the back erect, all sides should be lied at the same time in order to
place the WADiana® Compact in the required site.
WARNING!
The weight of the equipment is considerable, so
it is advisable to strictly follow these instructions
for placing it into position.
It must be lifted by four persons, holding it in the
manner shown (hands in the handles and with
their backs erect and flexing the legs).
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WADiana® Compact Equipment disposal
9 EQUIPMENT DISPOSAL
If the equipment is to be scrapped because it is no longer required for use, it
must be first completely cleaned and all possible remains of sample and reagents
eliminated. Once this has been done then it may be sent to an authorised centre
for this type of scrap.
WARNING!
This instrument should only be disassembled by
authorised specialists.
CAUTION!
When the instrument is at the end of its useful
life, you must take into account all local in force
regulations to discard it.
e WADiana® Compact is considered to be electronic waste. If in doubt, consult
the necessary information with your Technical Service or your distributor.
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3034072 Wadiana ES-EN:GRIFOLS 1/2/12 09:31 Página 95
WADiana® Compact Warranty
10 WARRANTY
e warranty conditions are set up in documents aside. contact your supplier in
case of any doubt. e following parts are excluded from warranty:
• RS-232 cable, mains cable and video cable.
• Tubes and fittings.
• Syringe.
• Bottle.
• Probe.
• Waste card tray
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modelo: nº serie: fecha de instalación:
Model: Serial Number: Installation date:
servIcIos De mantenImIento realIzaDos
MAINTENANCE SERVICES CARRIED OUT
WADiana® Compact
3034072 Wadiana ES-EN:GRIFOLS
tÉcnIco/autorIDaD
fecha accIón realIzaDa tÉcnIco/operaDor responsable
DATE WORK CARRIED OUT TECHNICIAN/OPERATOR TECHNICIAN/
1/2/12
RESPONSIBLE AUTHORITY
09:31
Página 97
MAINTENANCE SERVICES CARRIED OUT
SERVICIOS DE MANTENIMIENTO REALIZADOS /
I
Maintenance services carried outII
servIcIos De mantenImIento realIzaDos
MAINTENANCE SERVICES CARRIED OUT
tÉcnIco/autorIDaD
fecha accIón realIzaDa tÉcnIco/operaDor responsable
WADiana® Compact
DATE WORK CARRIED OUT TECHNICIAN/OPERATOR TECHNICIAN/
RESPONSIBLE AUTHORITY
3034072 Wadiana ES-EN:GRIFOLS
1/2/12
09:31
Página 98
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