Vircell VirClia Lotus User manual

User Manual

User manual
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Document Status Sheet
Title: VirClia® Lotus User Manual
Part
Number: UMVL
ID: UMVL, EN, V1.1
Translated
from: n/a
Version: Revision: Date: Document History:
1 0 2019-05-30 First release
1 1 2019-11-02 U date sections 4 and 5
M DELS
This manual a lies to the following VirClia Lotus models:
rder Code Model Description
30006590
V IR C LIA L OTUS
TECHNICAL ASSISTANCE
Vircell, S.L.
Parque Tecnológico de la Salud
Avicena 8, 18016 Granada, S ain
Tel.: [phone] - Ext 149
E-mail: customer[email protected]om
The information contained in this manual is subject to modifications without rior notice. No art of this manual may be
re roduced in any electronic or mechanical form for any ur ose whatsoever without the written authorization of Vircell S.L.
Printed in November 2019. (Total Pages: 50).
Standard a lied in this document:
UNI EN ISO 18113-3:2012
CEI EN 61010-1 II Edition File 6290 (October 2013)

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CEI EN 61010-2-101 I Edition File 7134 (November 2003)
LIABILITY DISCLAIMER .
This manual, its content and any other document related with VirClia Lotus ™ analyzer, including co yright and intellectual
ro erty rights are the sole ro erty of Vircell. In no event any art of this manual may be re roduced in any electronic or
mechanical form for any ur ose whatsoever without the written authorization of Vircell. This manual is rovided for infor-
mation ur oses only. The information contained in this manual is subject to modifications without rior notice. Vircell re-
serves the right to modify this manual and shall incur no liability as a result of such modification. Furthermore, Vircell will be
able to u date this manual in either documentary or electronic format. Users always should refer to the most u dated docu-
ments related to this manual.
The information about the VirClia Lotus ™ analyzer included in this user manual is built on the knowledge and accumulated
ex ertise by Vircell. The use of the VirClia Lotus ™ analyzer instrument is the full res onsibility of the user. This manual contains
all the information needed to use the instrument and kee it ready to o erate. Before the use of the instrument, therefore,
the user must read carefully this user manual. Also, lease read the ackage inserts of the reagents to be used. Vircell or any
other affiliate com anies are not liable for any injuries, loss or damages caused by bad ractices, intentional acts and omissions
or gross negligence of the user.
Any contact made by users in regards to the information contained in this manual (questions, feedback, etc.) shall not be
considered as confidential information and Vircell shall be free to disclose or use the information related to the mentioned
contact for any ur oses including, without limitation, the research, develo ment, manufacture, service, use, advertise or sale
of roducts incor orating such information. In any case, the sender of any information received by Vircell will be fully res on-
sible of the fulfillment of any legal requirement that may be a licable to such information. The sender s ecially will ensure
the non-infringement of any other third's ro rietary rights.
VirClia Lotus ™ and VirClia® Monotest are trademarks of Vircell which must not be used without the rior written a roval of
the owner.
USE OF THIS MANUAL BE CONSIDERED ACCEPTANCE OF THE TERMS AND CONDITIONS SET FORTH
HEREIN.

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C NTENTS
LIABILITY DISCLAIMER . .............................................................................................................................................. 3
1. INTRODUCTION .................................................................................................................................... 6
1.1. P REFACE ..................................................................................................................................................... 7
1.2. S YMBOLS ..................................................................................................................................................... 7
1.3. I NTENDED U SE ............................................................................................................................................. 8
1.4. G ENERAL D ESCRIPTION .................................................................................................................................. 8
1.5. T ECHNICAL S PECIFICATIONS .......................................................................................................................... 11
2. INSTALLATION .................................................................................................................................... 14
2.1. T ASKS OF THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT ......................................................................... 15
2.2. P RELIMINARY CHECK ................................................................................................................................... 16
2.3. P LACEMENT ............................................................................................................................................... 16
2.4. C ONNECTION ............................................................................................................................................. 17
2.5. S OFTWARE – D ESIGN AND S PECIFICATIONS ..................................................................................................... 17
3. OPERATING PROCEDURE .................................................................................................................... 19
3.1. B EFORE U SING THE INSTRUMENT .................................................................................................................. 20
3.2. B EFORE P ROGRAMMING AN A NALYSIS S ESSION ............................................................................................... 25
3.3. S ESSION P ROGRAMMING , R UNNING AND R ESULTS ........................................................................................... 25
3.3.1 W ASH B UFFER , C LEANING S OLUTION , AND W ASTE T ANK .................................................................................. 25
3.3.1.1 F ILL THE W ASH B UFFET T ANK (5L CAPACITY ) ........................................................................................... 25
3.3.1.2 F ILL THE D ISTILLED WATER TANK (0.25L CAPACITY ) ........................................................................................ 26
3.3.1.3 E MPTY T HE W ASTE T ANK ........................................................................................................................... 26
3.3.1.4 E MPTY THE S TRIP W ASTE C ONTAINER .......................................................................................................... 27
3.3.2. H OME S CREEN ............................................................................................................................................ 27
3.3.3. R UNNING S CREEN ....................................................................................................................................... 28
3.3.4. L OAD S AMPLES S CREEN ................................................................................................................................ 29
3.3.5. W ORKLIST S CREEN ...................................................................................................................................... 31
3.3.6. S HOPPING L IST S CREEN ................................................................................................................................ 32
3.3.7. L OAD R ESOURCES S CREENS ........................................................................................................................... 32
3.3.8. L OAD S TRIPS S CREEN ................................................................................................................................... 34
3.3.9. S TART THE A NALYSIS .................................................................................................................................... 37
3.3.10. R UNNING S CREEN ..................................................................................................................................... 37
3.3.11. C ONTINUOUS L OADING .............................................................................................................................. 38
3.3.12. R ESULTS .................................................................................................................................................. 39
3.3.13. E ND OF W ORK .......................................................................................................................................... 39
4. ERRORS & WARNING MESSAGES ....................................................................................................... 40
4.1 S AMPLE OR REAGENT LIQUID LEVEL DETECTION FAILURE .................................................................................... 41

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4.2 W ASH B UFFER L OW V OLUME ....................................................................................................................... 42
4.2.1. B EFORE U SING THE INSTRUMENT .................................................................................................................. 42
4.2.2. W ASH B UFFER E MPTY .............................................................................................................................. 43
4.3 W ASTE T ANK H IGH L EVEL ............................................................................................................................ 43
4.4 S TRIP W ASTE C ONTAINER F ULL ..................................................................................................................... 44
4.5 M OTOR OR H ARDWARE E RROR ..................................................................................................................... 45
5. MAINTENANCE ................................................................................................................................... 46
5.1. G ENERAL R ULES ......................................................................................................................................... 47
5.2. R ESPONSIBILITIES ........................................................................................................................................ 47
5.3. D AILY M AINTENANCE P ROCEDURE ................................................................................................................ 47
5.4. W EEKLY M AINTENANCE P ROCEDURE ............................................................................................................. 48
5.5. M ONTHLY M AINTENANCE P ROCEDURE .......................................................................................................... 49

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1. I NTR DUCTI N
1.1. P REFACE ................................................................................................................................................... 7
1.2. S YMBOLS .................................................................................................................................................. 7
1.3. I NTENDED U SE ........................................................................................................................................... 8
1.4. G ENERAL D ESCRIPTION ............................................................................................................................... 8
1.5. T ECHNICAL S PECIFICATIONS ....................................................................................................................... 11

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1.1. P REFACE
This document must be considered an integral art of the VIRCLIA LOTUS ™ instrument and the information here
following must be carefully read by the o erator before using the instrument.
The manufacturer recommends the o erator to read every section of the O erator’s Manual. It is necessary to ay
s ecial attention to the N TES, used to describe im ortant information for a ro er use of VirClia Lotus instrument
and to the WARNINGS, used to em hasize otential risks or dangers deriving from the instrument use.
The Manufacturer disclaims any res onsibility for artial or unauthorized co ies of the resent Manual.
1.2. S YMB LS
Legend of graphic symbols used on the Instrument
Instrument satisfying requirements of Euro ean directive on in vitro diagnostic medical devices
(98/79/EC).
In vitro diagnostic medical device.
Instrument satisfying MET standards for the U.S.A. and Canadian market
Date of manufacturing of the unit.
Serial number of the unit.
Manufactured data.
Legend of Electrical and Safety symbols used on the instrument
Protective conductor terminal.
RAEE: Electric-Electronics Instrument – Se arate com ulsory collection of waste under D.L.
25/07/2005 n° 151 (Italy), im lementation of 2002/96/EC and 2003/108/EC Directives.
Warning read the Manual and ay attention to the safety symbols.
Warning, risk of electric shock.
Warning, hot surface.
Warning, biohazard.
Warning, hands rick/cut danger.
Warning, crush danger.
Warning, laser beam.

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1.3. I NTENDED U SE
The VIRCLIA LOTUS ™ is an analyzer, with “Lotus” a lication software integrated, designed for the automation of
medical diagnostic techniques erformed with in vitro chemiluminescence immunoassay (CLIA), on s ecial Devices
called VirClia® Monotest.
Figure 1.3-01. VirClia® Monotest Device Sam le
VirClia Lotus ™ automates the testing in a ra id, accurate and recise sequence, the ste s of the diagnostic tests that
have been enabled. This includes the dilution and dis ensing of sam les and controls, dis ensing of reagents,
incubation, shaking, washing, reading, rocessing, inter retation and archiving of results.
The o eration is subject to the instructions, terms and conditions detailed in this User Manual. The costumer must
follow the manufacturer's instructions for erforming the diagnostic test in order to minimize the chance of error. If
the user modifies the instructions, the test no longer meets the requirements for VirClia Lotus ™ a ro riate results.
VirClia Lotus ™ analyzer has been develo ed and tested according to the Regulation (EU) 2017/746 on In Vitro
Diagnostic medical devices. The instrument is intended only for rofessional In Vitro Diagnostic use and the system
works ro erly only with VirClia® chemiluminesce assays. Therefore, it is not allowed to erform tests with VirClia
Lotus ™ if reagents are not rovided or authorized by Vircell.
Users are not allowed to make changes neither to the instrument nor to the software which are not authorized by
Vircell. The consequence of using different reagents to VirClia® or any changes made in the instrument without the
aforementioned authorization could be a loss of the conformity to the a licable regulations that the manufacturer
has declared. In this case, the customer will be exclusively res onsible for the fulfilment of the a licable regulations
as well as all the ossible legal liabilities derived from any infringement of the laws in force that rotect the intellectual
rights and interests of Vircell.
1.4. G ENERAL D ESCRIPTI N
VirClia Lotus ™ is a closed system dedicated to rocess diagnostics immunoassays based on VirClia® Monotest Devices.
For each assay there is a dedicated Monotest Device, and a s ecific rocess. For each sam le one or more assays can
be rocessed in order to determine one or more arameters in the same analysis session, this means that to rocess
one sam le, one or more VirClia® Monotest Devices will be loaded on the instrument. The VirClia Lotus is able to
su ort continuous loading of the sam les and Monotest Devices, this will allow the user to add new sam les and
devices and rogram their assays, also while the instrument is rocessing those reviously loaded, thanks to its high
flexibility.

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Figure.1.4-01 ‘Front View (Door Closed)’
Figure 1.4-02 ‘Front View (Lids O en)’
Legend:
1 Sam le Rotor
⑥ Wash Buffer Container
2 Sam le Needle Arm 7 Distilled Water tank
3 Stri Rotor 8 Additional Reagents Rack
4 Sam le Needle Washing Well 9 Cover Locking Magnets
5 Stri s Waste Box  Waste liquid container

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1- Sample rotor: Sam les tubes, re-dilution cuvettes and diluent bottles used during the assay are laced in this
rotor.
2- Sample needle arm for sample preparation: This arm holds the needle used in the first i etting stage.
3- Strip rotor: The stri s needed during the assay are located in this rotor.
4- Sample needle wash station for sample preparation: This is the washing station for the sam le needle where
the first i etting stage is carried out. Both the inside and outside of the needle is cleaned in this washing sta-
tion.
5- Strips waste box: A waste container where the stri s used are discarded automatically after the assay.
6- Wash buffer container: The washing solution re ared accordingly to the manufacturer s ecifications is con-
tained in this tank. The ca acity is 5 liters. The instrument contains a balance to weight the wash buffer solu-
tion.
7- Distilled water tank: The DI water used during the maintenance is stored in this tank. The ca acity is 0.25 liters.
The instrument contains a balance to weight the DI water.
8- Additional reagents racks: Rack used for additional reagents such as avidity and/or decontamination solution.
9- Cover locking magnets: Electromagnets used for the instrument cover locking during the assay.
10- Waste liquid container: This tank is used for the liquid waste generated during the assay. The ca acity is 5 liters.
The instrument contains a balance to weight liquid waste.
The VirClia Lotus ™ is equi ed with three rotors. Two of them are located in the user accessible area, one is used to
load the Sam les tubes and re-dilution cuvettes together with the Diluent bottles (Samples Rotor), the other one is
used to load the Monotest Devices (Strip Rotor). The third rotor is called the Reaction Rotor and is the one where the
assay’s rocedure is actually erformed. The Monotest Devices washing unit, the reagent’s dis ensing needle, the
shaking units and the Reading Unit, are located over it. Moreover, the Reaction Rotor is heated in order to erform
the incubation of the Monotest Devices.

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1.5. T ECHNICAL S PECIFICATI NS
P
OWER SUPPLY
E
UROPE
:
230V
AC
@50H
Z
U
SA
/C
ANADA
:
110
-
120V
AC
@60H
Z
E LECTRICAL P OWER CONSUMPTION
365
VA
F USES
2
X
10.0A
T
(5
X
20
MM
)
D IMENSIONS
750x740x650mm
(
L X H X D
)
W EIGHT
70
K
G
/
155
L
BS
(
MAX
)
A MBIENT TEMPERATURE
O
PERATIONAL FROM
+18°C
TO
+
35
°C
O
PTIMAL
:
20
-
25
º
C
S
TORAGE FROM
+
5°C
TO
+
45°C
R ELATIVE HUMIDITY THRESHOLD FROM 20 TO 80% WITHOUT CONDENSATION
A LTITUDE
FROM
0
TO
3
000
METERS
N OISE L EVEL
<
75db
(D
ECIBEL
)
H EAT OUTPUT
500
BTU/H
OUR
E MBEDDED C PU B OARD
STM32F4
P
ROCESSOR WITH
8MB
SDRAM
,
1MB
F
LASH
,
1KB
EEPROM,
M ICRO -SD CARD FOR INTERNAL FILE STORAGE
P ERIPHERAL C ONTROL U NITS M ICROPROCESSOR BOARD ON HOST B US
I NTERFACE
1
USB
C
LIENT FOR HOST COMMUNICATION
S AMPLES – C APACITY
50
SAMPLE TUBES
M ONOTEST D EVICES S TRIPS – C APACITY
39
IN THE STRIP LOADING
R
OTOR
+
40
IN THE
R
EACTION
R
OTOR
D ILUENT B OTTLES - C APACITY
6
BOTTLES
P RE - DILUTION C UVETTES - C APACITY
50
CUVETTES
R EAGENTS BOTTLES – C APACITY
5
+
1
BOTTLE FOR DECONTAMINANT SOLUTION FOR SAMPLES NEEDLE
W ASHER TANK - C APACITY
5
L
ITERS X
1
T
ANK
D ISTILLED WATER – CAPACITY
0.
2
5
L
ITERS X
1
TANK
W ASTE TANK - C APACITY
5
L
ITERS X
1
T
ANK
M ONOTEST D EVICES STRIPS
WASTE BOX – C APACITY
80 STRIPS
P ROTECTION C ATEGORY
C
LASS
I

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S AFETY S TANDARDS
CEI
EN
61010
-
1
(E
D
.20
13
-
1
0
);
CAN/CSA-C22.2 N R .61010-1-04 (E D .2004-07);
UL61010-1 (E D .2004-07)
EMC S TANDARDS
CEI
EN
61326
-
1
(E
D
.
2013
-
07
);
CEI EN 61326-2-6 (E D .2014-06)
I NSTALLATION CATEGORY
II
The safety and erformance of the instrument is not ensured if a ower su ly cable other than the one su lied is
used. (Even if com atible with ower su ly network of the installation country).
The analyzer contains nr. 1 battery Li-Mh CR2032 on the CPU board.
M INIMUM REQUIREMENTS OF THE WORKSTATION :
C OMPUTER
• I NTEL CORE I 3 /2.8 GH Z PROCESSOR P ERSONAL C OMPUTER
• 4G BYTE RAM
• 256 G B H ARD D ISK
• 100/1000 M BIT E THERNET RJ45 PORT
• FULL HD CAPABLE D ISPLAY OUTPUT PORT
• 4 USB P ORT
•A UDIO - OUT CONNECTOR
KEYBOARD
USB ALPHANUMERIC ( STANDARD )
MOUSE
USB M OUSE
V IDEO M ONITOR
24” (1920 X 1080) FULL HD, (P REFERABLY T OUCH SCREEN MONITOR )
S PEAKERS
2 CHANNELS
P RINTER
A NY PRINTER SUPPORTED BY THE OS
OPERATING SYSTEM
W INDOWS 10 P ROFESSIONAL X 64

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UPS FEATURES ( FOR NE H UR OF AUTONOMY ):
D IMENSIONED TO SUPPLY ANALYZER , COMPUTER , PRINTER AND MONITOR
R ECOMMENDED N OMINAL P OWER
1100 VA
W ORKING M ODE
O N -L INE WITH DOUBLE CONVERSION , NO INTERVENTION DELAY .
M INIMUM B ATTERY CAPACITY
14 A H
O
UTPUT
C
HARACTERISTICS
:
•V OLTAGE DISTORTION WITH NON - LINEAR LOAD
•W AVEFORM
•C URRENT CREST FACTOR
< 4%
S INUSOIDAL
3 : 1
I NTERFACE
S ERIAL OR USB PORT .
A S UPERVISION S OFTWARE MUST BE SUPPLIED FOR M ICROSOFT W IN-
DOWS O PERATING S YSTEMS : W INDOWS 10
To identify the right UPS for the instrument installation country, refer to the local country features network ower
su ly.

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2. I NSTALLATI N
2.1. T ASKS OF THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT ...................................................................... 15
2.2. P RELIMINARY CHECK ................................................................................................................................. 16
2.3. P LACEMENT ............................................................................................................................................ 16
2.4. C ONNECTION .......................................................................................................................................... 17
2.5. S OFTWARE - DESIGN AND S PECIFICATIONS ..................................................................................................... 17

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2.1. T ASKS F THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT
The following ste s must be taken before any instrument service or maintenance.
a) TURN OFF THE POWER SWITCH ON THE RIGHT SIDE OF THE INSTRUMENT
b) UNPLUG THE INSTRUMENT FROM THE U.P.S. POWER SUPPLY OR POWER OUTLET TO GARANTY YOUR SAFETY
FROM ELECTRICAL AND MECHANICAL DANGER
FAILURE TO FOLLOW THE ADVICE AND INSTRUCTIONS IN THIS DOCUMENT RELEASE THE MANUFACTURER FROM ALL
LIABILITY AND MAY CAUSE INSTRUMENT DAMAGE.
NECESSARY EQUIPMENT / INSTRUMENTATI N: ¡
T OOLS REQUIRED FOR MAINTENANCE :
Digital multimeter.
Harta STRIPT
Tem erature sensor
Dye kit
Verification kit
Set of screwdrivers with cross head.
Set of Allen wrenches.
5.5 mm and 7 mm Socket wrenches.
Set of O en-ended s anners or wrenches (including 5.5mm and 5mm).
Circli s Pliers.
Tweezers.
RS232 to USB Converter.
[C ODE 3050] A SSISTANCE K IT COMPOSED BY :
[C ODE 11400060] L OCTITE 243 Thread locker (Medium-strength).
[C ODE 12400040] Lubricant S ray WD-40 200ml.
[C ODE 19900860] S ecial Allen wrench 2.5-3 mm T-Handle.

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2.2. P RELIMINARY CHECK
For the instruments and the o erator safety the following conditions are required:
•The ower su ly network (installation category II), must be “com atible” with the s ecifications of voltage and
current on the identification label affixed on the instrument side. To ensure the ro er functioning of the
instrument, lease check of the building electrical system out ut before to installation.
•The electrical system outlet must be ro erly grounded as defined by the standards for outlet electrical
installation.
•Before making the connections, verify the com atibility with the external equi ment like host or PC (with the
user manual) and remember to connect the cables only with external devices ower switch in off osition. Verify
the continuity of the ground in the electrical system.
•IT IS ABSOLUTELY FORBIDDEN to remove or modify or override any of the safety devices installed on the
instrument.
It's advised to connect the analyzer on an uninterruptible Power Supply system (UPS) to ensure the regular
operation in case of malfunction of the electrical system.
2.3. P LACEMENT
The VirClia Lotus™ analyzer is intended for use in clinical and research laboratories.
The instrument must be ositioned away from any heat source, in an environment free of dust, on level surface that
is free of vibrations and oscillations on the workbench.
It’s advised to use a workbench with a sufficient range of weight tolerance and 80 cm of height to ensure an
ergonomically correct osition during the loading and extracting o eration from the instruments work area.
80 cm

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The VirClia Lotus™ is com liant with the electromagnetic com atibility directive; however it is advised that the
instrument should be laced on a dedicated circuit and not on circuits with other ossible electromagnetic source like
refrigerators, laboratory centrifuges, or instruments without CE mark that can interfere with the correct o eration of
the instruments.
The instrument requires a lacement at least 20 cm from the wall, to have access at the mains cable on the external
side of the instrument and to rovide access to the instrument in order to intervene quickly in the case of an
instrument malfunction. The instruments cover must remain unobstructed and accessible. Do not store any materials
on top of the instrument.
If you do not use the instrument for an extended eriod it is advised to execute the decontamination/sanitization of
the internal arts as described in the user manual and then disconnect the ower su ly cable and rotect the
instrument and its eri herals from the dust.
2.4. C NNECTI N
To connect the mains su ly cable:
1. Verify the OFF osition of the main switch.
2. Connect the main ower su ly cable in the mains inlet located on the right side of the instrument, and at the
ower su ly outlet or at the UPS unit.
To connect the PC:
1. Place the Personal Com uter, Keyboard, Monitor and Printer near the Instrument.
2. Connect the USB 2.0 com liant Cable* to the USB host ort of the PC.
3. Connect the other end of the cable in the USB Device ort located on the right side of the instrument.
4. Connect the keyboard, monitor and rinter to the PC.
5. Connect com uter and monitor at the mains ower su ly or UPS unit.
*The cable for the external connection must not exceed 2 meters in length.
2.5. S FTWARE – D ESIGN AND S PECIFICATI NS
Description and requirements specification
The software used in the equi ment manages the user interface of the instrument. This software allows creating and
executing lists of tasks, result analysis of different assays, and check the obtained results.
This software ermits the connection with any laboratory com uter system (LIS) using the middleware VIRCOM.
VirClia® Lotus System includes different acoustic and visual signals for different situations when the user action is
needed.

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The software ackage needed for the correct erformance of the instrument comes installed in the PC, ready to be
used.
The a lication has been develo ed by a lying the EN 62304:2007 standard. This standard establishes a classification
of the software on the basis of its critical nature and otential im act on the atient's health / clinical status.
The class for the overall system software is:
- Class B: non-serious injury is ossible
The instrument includes a CPU board which allows the autonomous com letion of a run once it has been launched.
This CPU board includes a STM32f4 rocessor with 8mb SD-RAM, 1mb flash, 1kb EEPROM, micro-SD card for internal
file storage with 8GB (HC1) ty e 10.

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3. PERATING P R CEDURE
3.1. B EFORE U SING THE INSTRUMENT ................................................................................................................ 20
3.2. B EFORE P ROGRAMMING AN A NALYSIS S ESSION ............................................................................................ 25
3.3. S ESSION P ROGRAMMING , R UNNING AND R ESULTS ........................................................................................ 25
3.3.1 W ASH B UFFER , C LEANING S OLUTION , AND W ASTE T ANK ............................................................................... 25
3.3.1.1 F ILL THE W ASH B UFFET T ANK (5L CAPACITY ) ................................................................................................ 25
3.3.1.2 F ILL THE D ISTILLED WATER TANK (0.25L CAPACITY ) ........................................................................................ 26
3.3.1.3 E MPTY T HE W ASTE T ANK .......................................................................................................................... 26
3.3.1.4 E MPTY THE S TRIP W ASTE C ONTAINER .......................................................................................................... 27
3.3.2. H OME S CREEN ......................................................................................................................................... 27
3.3.3. R UNNING S CREEN .................................................................................................................................... 28
3.3.4. L OAD S AMPLES S CREEN ............................................................................................................................. 29
3.3.5. W ORKLIST S CREEN ................................................................................................................................... 31
3.3.6. S HOPPING L IST S CREEN ............................................................................................................................. 32
3.3.7. L OAD R ESOURCES S CREENS ........................................................................................................................ 32
3.3.8. L OAD S TRIPS S CREEN ................................................................................................................................ 34
3.3.9. S TART THE A NALYSIS ................................................................................................................................. 37
3.3.10. R UNNING S CREEN .................................................................................................................................... 37
3.3.11. C ONTINUOUS L OADING ............................................................................................................................. 38
3.3.12. R ESULTS ................................................................................................................................................. 39
3.3.13. E ND OF W ORK ......................................................................................................................................... 39

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3.1. B EF RE U SING THE INSTRUMENT
General Precautions
The o erators that work on VirClia Lotus must have a good working knowledge of in vitro diagnostics tests (IVD).
When using VirClia® Lotus, safety instructions must be followed. It is necessary to read this manual rior to using the
instrument. VirClia® Lotus has been designed according to safety rotocols for electric devices s ecified in the certifi-
cations reviously mentioned, with the goal of guarantee the correct erformance of the instrument, both electrically
and mechanically, under normal conditions of use.
The equi ment must be closed and its internal arts inaccessible. When the trial is underway, the equi ment must be
closed with all its com onents not accessible. Never remove the rotective covers or the safety com onents of the
equi ment.
The im ortance of following the instructions stated in this manual must be taken into account, in order to obtain
reliable results from the assays erformed in this instrument.
In order to ensure ro er use of VirClia Lotus, it is recommended to follow the general recautions listed below:
Installation must be carried out by the Vircell S.L. Technical service or by trained staff; only the authorized technical
service or the erson in charge of the instrument must trans ort or move the equi ment, since it contains fragile
material.
•It is not allowed to override the safety and rotection devices of the access door (micro switch and electromag-
netic sealing) of VirClia Lotus;
•Do not try to erform re airs or adjustments on VirClia Lotus without first contacting the Vircell S.L. Technical
Service. If the o erator does work without authorization, the warranty rights will be lost;
•Do not install any s are arts not rovided by Vircell S.L.;
•Do not try to modify the software or the O erating System. The required software and o erating system u dates
are rovided by Vircell S.L.;
•In case of VirClia Lotus malfunction, sto using the instrument and contact the Vircell S.L. Technical Service;
•Before running the tests, consult this User Manual. Kee the User Manual at hand in the laboratory for an easy
reference if needed.
•This manual includes information on the use of only accessories and com onents a roved by the manufacturer.
Equi ment design including accessories to be used with the equi ment. The instrument is designed to be used
only with reagents established by the manufacturer. Only these reagents should be used to ensure ro er equi -
ment o eration.
•This manual includes information about o erational rograms including errors messages and warnings that could
a ear during the o erational rocedure, stated in the section 4 errors and warning messages.
•This manual includes information on ins ection, cleaning and control to be done before use, stated in the section
3.1.