User Manual

User manual

Document Status Sheet

Part
Title: VirClia® Lotus User Manual UMVL
Number:
Translated
ID: UMVL, EN, V1.1 n/a
from:
Version: Revision: Date: Document History:
1 0 2019-05-30 First release
1 1 2019-11-02 Update sections 4 and 5

MODELS

This manual applies to the following VirClia Lotus models:

Order Code Model Description

30006590 VIRCLIA LOTUS

TECHNICAL ASSISTANCE

Vircell, S.L.
Parque Tecnológico de la Salud
Avicena 8, 18016 Granada, Spain
Tel.: +34 958 441 264 - Ext 149
E-mail: customerservice@vircell.com

The information contained in this manual is subject to modifications without prior notice. No part of this manual may be
reproduced in any electronic or mechanical form for any purpose whatsoever without the written authorization of Vircell S.L.

Printed in November 2019. (Total Pages: 50).

Standard applied 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 copyright and intellectual
property rights are the sole property of Vircell. In no event any part of this manual may be reproduced in any electronic or
mechanical form for any purpose whatsoever without the written authorization of Vircell. This manual is provided for infor-
mation purposes only. The information contained in this manual is subject to modifications without prior 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 update this manual in either documentary or electronic format. Users always should refer to the most updated 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
expertise by Vircell. The use of the VirClia Lotus ™ analyzer instrument is the full responsibility of the user. This manual contains
all the information needed to use the instrument and keep it ready to operate. Before the use of the instrument, therefore,
the user must read carefully this user manual. Also, please read the package inserts of the reagents to be used. Vircell or any
other affiliate companies are not liable for any injuries, loss or damages caused by bad practices, 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 purposes including, without limitation, the research, development, manufacture, service, use, advertise or sale
of products incorporating such information. In any case, the sender of any information received by Vircell will be fully respon-
sible of the fulfillment of any legal requirement that may be applicable to such information. The sender specially will ensure
the non-infringement of any other third's proprietary rights.

VirClia Lotus ™ and VirClia® Monotest are trademarks of Vircell which must not be used without the prior written approval of
the owner.

USE OF THIS MANUAL BE CONSIDERED ACCEPTANCE OF THE TERMS AND CONDITIONS SET FORTH
HEREIN.

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CONTENTS
LIABILITY DISCLAIMER. .............................................................................................................................................. 3

1. INTRODUCTION .................................................................................................................................... 6
1.1. PREFACE ..................................................................................................................................................... 7
1.2. SYMBOLS..................................................................................................................................................... 7
1.3. INTENDED USE ............................................................................................................................................. 8
1.4. GENERAL DESCRIPTION .................................................................................................................................. 8
1.5. TECHNICAL SPECIFICATIONS .......................................................................................................................... 11
2. INSTALLATION .................................................................................................................................... 14
2.1. TASKS OF THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT ......................................................................... 15
2.2. PRELIMINARY CHECK ................................................................................................................................... 16
2.3. PLACEMENT ............................................................................................................................................... 16
2.4. CONNECTION ............................................................................................................................................. 17
2.5. SOFTWARE – DESIGN AND SPECIFICATIONS ..................................................................................................... 17
3. OPERATING PROCEDURE.................................................................................................................... 19
3.1. BEFORE USING THE INSTRUMENT .................................................................................................................. 20
3.2. BEFORE PROGRAMMING AN ANALYSIS SESSION ............................................................................................... 25
3.3. SESSION PROGRAMMING, RUNNING AND RESULTS........................................................................................... 25
3.3.1 WASH BUFFER, CLEANING SOLUTION, AND WASTE TANK .................................................................................. 25
3.3.1.1 FILL THE WASH BUFFET TANK (5L CAPACITY) ........................................................................................... 25
3.3.1.2 FILL THE DISTILLED WATER TANK (0.25L CAPACITY) ........................................................................................ 26
3.3.1.3 EMPTY THE WASTE TANK ........................................................................................................................... 26
3.3.1.4 EMPTY THE STRIP WASTE CONTAINER .......................................................................................................... 27
3.3.2. HOME SCREEN............................................................................................................................................ 27
3.3.3. RUNNING SCREEN ....................................................................................................................................... 28
3.3.4. LOAD SAMPLES SCREEN................................................................................................................................ 29
3.3.5. WORKLIST SCREEN ...................................................................................................................................... 31
3.3.6. SHOPPING LIST SCREEN ................................................................................................................................ 32
3.3.7. LOAD RESOURCES SCREENS........................................................................................................................... 32
3.3.8. LOAD STRIPS SCREEN ................................................................................................................................... 34
3.3.9. START THE ANALYSIS.................................................................................................................................... 37
3.3.10. RUNNING SCREEN ..................................................................................................................................... 37
3.3.11. CONTINUOUS LOADING .............................................................................................................................. 38
3.3.12. RESULTS .................................................................................................................................................. 39
3.3.13. END OF WORK.......................................................................................................................................... 39
4. ERRORS & WARNING MESSAGES ....................................................................................................... 40
4.1 SAMPLE OR REAGENT LIQUID LEVEL DETECTION FAILURE .................................................................................... 41

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4.2 WASH BUFFER LOW VOLUME ....................................................................................................................... 42

4.2.1. BEFORE USING THE INSTRUMENT .................................................................................................................. 42
4.2.2. WASH BUFFER EMPTY .............................................................................................................................. 43
4.3 WASTE TANK HIGH LEVEL ............................................................................................................................ 43
4.4 STRIP WASTE CONTAINER FULL ..................................................................................................................... 44
4.5 MOTOR OR HARDWARE ERROR..................................................................................................................... 45
5. MAINTENANCE ................................................................................................................................... 46
5.1. GENERAL RULES ......................................................................................................................................... 47
5.2. RESPONSIBILITIES ........................................................................................................................................ 47
5.3. DAILY MAINTENANCE PROCEDURE ................................................................................................................ 47
5.4. WEEKLY MAINTENANCE PROCEDURE ............................................................................................................. 48
5.5. MONTHLY MAINTENANCE PROCEDURE .......................................................................................................... 49

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1. INTRODUCTION

1.1. PREFACE ................................................................................................................................................... 7

1.2. SYMBOLS .................................................................................................................................................. 7
1.3. INTENDED USE........................................................................................................................................... 8
1.4. GENERAL DESCRIPTION ............................................................................................................................... 8
1.5. TECHNICAL SPECIFICATIONS .......................................................................................................................11

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1.1. PREFACE
This document must be considered an integral part of the VIRCLIA LOTUS ™ instrument and the information here
following must be carefully read by the operator before using the instrument.
The manufacturer recommends the operator to read every section of the Operator’s Manual. It is necessary to pay
special attention to the NOTES, used to describe important information for a proper use of VirClia Lotus instrument
and to the WARNINGS, used to emphasize potential risks or dangers deriving from the instrument use.

The Manufacturer disclaims any responsibility for partial or unauthorized copies of the present Manual.

1.2. SYMBOLS
Legend of graphic symbols used on the Instrument
Instrument satisfying requirements of European 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 – Separate compulsory collection of waste under D.L.

25/07/2005 n° 151 (Italy), implementation of 2002/96/EC and 2003/108/EC Directives.

Warning read the Manual and pay attention to the safety symbols.

Warning, risk of electric shock.

Warning, hot surface.

Warning, biohazard.

Warning, hands prick/cut danger.

Warning, crush danger.

Warning, laser beam.

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1.3. INTENDED USE

The VIRCLIA LOTUS ™ is an analyzer, with “Lotus” application software integrated, designed for the automation of
medical diagnostic techniques performed with in vitro chemiluminescence immunoassay (CLIA), on special Devices
called VirClia® Monotest.

Figure 1.3-01. VirClia® Monotest Device Sample

VirClia Lotus ™ automates the testing in a rapid, accurate and precise sequence, the steps of the diagnostic tests that
have been enabled. This includes the dilution and dispensing of samples and controls, dispensing of reagents,
incubation, shaking, washing, reading, processing, interpretation and archiving of results.

The operation is subject to the instructions, terms and conditions detailed in this User Manual. The costumer must
follow the manufacturer's instructions for performing 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 ™ appropriate results.

VirClia Lotus ™ analyzer has been developed and tested according to the Regulation (EU) 2017/746 on In Vitro
Diagnostic medical devices. The instrument is intended only for professional In Vitro Diagnostic use and the system
works properly only with VirClia® chemiluminesce assays. Therefore, it is not allowed to perform tests with VirClia
Lotus ™ if reagents are not provided 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 applicable regulations that the manufacturer
has declared. In this case, the customer will be exclusively responsible for the fulfilment of the applicable regulations
as well as all the possible legal liabilities derived from any infringement of the laws in force that protect the intellectual
rights and interests of Vircell.

1.4. GENERAL DESCRIPTION

VirClia Lotus ™ is a closed system dedicated to process diagnostics immunoassays based on VirClia® Monotest Devices.
For each assay there is a dedicated Monotest Device, and a specific process. For each sample one or more assays can
be processed in order to determine one or more parameters in the same analysis session, this means that to process
one sample, one or more VirClia® Monotest Devices will be loaded on the instrument. The VirClia Lotus is able to
support continuous loading of the samples and Monotest Devices, this will allow the user to add new samples and
devices and program their assays, also while the instrument is processing those previously 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 Open)’

Legend:

1 Sample Rotor ⑥ Wash Buffer Container

2 Sample Needle Arm 7 Distilled Water tank

3 Strip Rotor 8 Additional Reagents Rack
4 Sample Needle Washing Well 9 Cover Locking Magnets
5 Strips Waste Box Waste liquid container

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1- Sample rotor: Samples tubes, pre-dilution cuvettes and diluent bottles used during the assay are placed in this
rotor.

2- Sample needle arm for sample preparation: This arm holds the needle used in the first pipetting stage.

3- Strip rotor: The strips needed during the assay are located in this rotor.

4- Sample needle wash station for sample preparation: This is the washing station for the sample needle where
the first pipetting 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 strips used are discarded automatically after the assay.

6- Wash buffer container: The washing solution prepared accordingly to the manufacturer specifications is con-
tained in this tank. The capacity 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 capacity 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 capacity is 5 liters.
The instrument contains a balance to weight liquid waste.

The VirClia Lotus ™ is equipped with three rotors. Two of them are located in the user accessible area, one is used to
load the Samples tubes and pre-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 procedure is actually performed. The Monotest Devices washing unit, the reagent’s dispensing needle, the
shaking units and the Reading Unit, are located over it. Moreover, the Reaction Rotor is heated in order to perform
the incubation of the Monotest Devices.

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1.5. TECHNICAL SPECIFICATIONS

POWER SUPPLY EUROPE: 230VAC@50HZ USA/CANADA: 110-120VAC@60HZ

ELECTRICAL POWER CONSUMPTION 365 VA

FUSES 2 X 10.0A T (5 X 20 MM)

DIMENSIONS 750x740x650mm ( L X H X D )

WEIGHT 70 KG /155 LBS (MAX)

OPERATIONAL FROM +18°C TO + 35°C OPTIMAL: 20-25ºC

AMBIENT TEMPERATURE
STORAGE FROM + 5°C TO + 45°C

RELATIVE HUMIDITY THRESHOLD FROM 20 TO 80% WITHOUT CONDENSATION

ALTITUDE FROM 0 TO 3000 METERS

NOISE LEVEL < 75db (DECIBEL)

HEAT OUTPUT 500 BTU/HOUR

EMBEDDED CPU BOARD STM32F4 PROCESSOR WITH 8MB SDRAM, 1MB FLASH, 1KB EEPROM,
MICRO-SD CARD FOR INTERNAL FILE STORAGE

PERIPHERAL CONTROL UNITS MICROPROCESSOR BOARD ON HOST BUS

INTERFACE 1 USB CLIENT FOR HOST COMMUNICATION

SAMPLES – CAPACITY 50 SAMPLE TUBES

MONOTEST DEVICES STRIPS – CAPACITY 39 IN THE STRIP LOADING ROTOR + 40 IN THE REACTION ROTOR

DILUENT BOTTLES - CAPACITY 6 BOTTLES

PRE-DILUTION CUVETTES - CAPACITY 50 CUVETTES

REAGENTS BOTTLES – CAPACITY 5 + 1 BOTTLE FOR DECONTAMINANT SOLUTION FOR SAMPLES NEEDLE

WASHER TANK - CAPACITY 5 LITERS X 1 TANK

DISTILLED WATER – CAPACITY 0.25 LITERS X 1 TANK

WASTE TANK - CAPACITY 5 LITERS X 1 TANK

MONOTEST DEVICES STRIPS

80 STRIPS
WASTE BOX – CAPACITY

PROTECTION CATEGORY CLASS I

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SAFETY STANDARDS CEI EN 61010-1 (ED.2013-10);

CAN/CSA-C22.2 NR.61010-1-04 (ED.2004-07);
UL61010-1 (ED.2004-07)

EMC STANDARDS CEI EN 61326-1 (ED.2013-07);

CEI EN 61326-2-6 (ED.2014-06)

INSTALLATION CATEGORY II

The safety and performance of the instrument is not ensured if a power supply cable other than the one supplied is
used. (Even if compatible with power supply network of the installation country).

The analyzer contains nr. 1 battery Li-Mh CR2032 on the CPU board.

MINIMUM REQUIREMENTS OF THE WORKSTATION:

COMPUTER • INTEL CORE I3 /2.8 GHZ PROCESSOR PERSONAL COMPUTER

• 4GBYTE RAM
• 256 GB HARD DISK
• 100/1000 MBIT ETHERNET RJ45 PORT
• FULL HD CAPABLE DISPLAY OUTPUT PORT
• 4 USB PORT

•AUDIO-OUT CONNECTOR

KEYBOARD USB ALPHANUMERIC (STANDARD)

MOUSE USB MOUSE

VIDEO MONITOR 24” (1920 X 1080) FULL HD, (PREFERABLY TOUCH SCREEN MONITOR)

SPEAKERS 2 CHANNELS

PRINTER ANY PRINTER SUPPORTED BY THE OS

OPERATING SYSTEM WINDOWS 10 PROFESSIONAL X64

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UPS FEATURES (FOR ONE HOUR OF AUTONOMY):
DIMENSIONED TO SUPPLY ANALYZER, COMPUTER, PRINTER AND MONITOR

RECOMMENDED NOMINAL POWER 1100 VA

WORKING MODE ON-LINE WITH DOUBLE CONVERSION, NO INTERVENTION DELAY.

MINIMUM BATTERY CAPACITY 14 AH

OUTPUT CHARACTERISTICS:
• VOLTAGE DISTORTION WITH NON-LINEAR LOAD < 4%
• WAVEFORM SINUSOIDAL
• CURRENT CREST FACTOR 3:1

INTERFACE SERIAL OR USB PORT.

A SUPERVISION SOFTWARE MUST BE SUPPLIED FOR MICROSOFT WIN-
DOWS OPERATING SYSTEMS: WINDOWS 10

To identify the right UPS for the instrument installation country, refer to the local country features network power
supply.

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2. INSTALLATION

2.1. TASKS OF THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT ......................................................................15

2.2. PRELIMINARY CHECK .................................................................................................................................16
2.3. PLACEMENT ............................................................................................................................................16
2.4. CONNECTION ..........................................................................................................................................17
2.5. SOFTWARE-DESIGN AND SPECIFICATIONS .....................................................................................................17

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2.1. TASKS OF THE TECHNICAL ASSISTANCE / NECESSARY EQUIPMENT

The following steps 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 / INSTRUMENTATION: ¡

TOOLS REQUIRED FOR MAINTENANCE:
Digital multimeter.
Harta STRIPT
Temperature 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 Open-ended spanners or wrenches (including 5.5mm and 5mm).
Circlips Pliers.
Tweezers.
RS232 to USB Converter.

[CODE 3050] ASSISTANCE KIT COMPOSED BY:

[CODE 11400060] LOCTITE 243 Thread locker (Medium-strength).

[CODE 12400040] Lubricant Spray WD-40 200ml.
[CODE 19900860] Special Allen wrench 2.5-3 mm T-Handle.

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2.2. PRELIMINARY CHECK

For the instruments and the operator safety the following conditions are required:
• The power supply network (installation category II), must be “compatible” with the specifications of voltage and
current on the identification label affixed on the instrument side. To ensure the proper functioning of the
instrument, please check of the building electrical system output before to installation.
• The electrical system outlet must be properly grounded as defined by the standards for outlet electrical
installation.
• Before making the connections, verify the compatibility with the external equipment like host or PC (with the
user manual) and remember to connect the cables only with external devices power switch in off position. 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. PLACEMENT
The VirClia Lotus™ analyzer is intended for use in clinical and research laboratories.
The instrument must be positioned 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 position during the loading and extracting operation from the instruments work area.

80 cm

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The VirClia Lotus™ is compliant with the electromagnetic compatibility directive; however it is advised that the
instrument should be placed on a dedicated circuit and not on circuits with other possible electromagnetic source like
refrigerators, laboratory centrifuges, or instruments without CE mark that can interfere with the correct operation of
the instruments.

The instrument requires a placement at least 20 cm from the wall, to have access at the mains cable on the external
side of the instrument and to provide 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 period it is advised to execute the decontamination/sanitization of
the internal parts as described in the user manual and then disconnect the power supply cable and protect the
instrument and its peripherals from the dust.

2.4. CONNECTION

To connect the mains supply cable:

1. Verify the OFF position of the main switch.
2. Connect the main power supply cable in the mains inlet located on the right side of the instrument, and at the
power supply outlet or at the UPS unit.

To connect the PC:

1. Place the Personal Computer, Keyboard, Monitor and Printer near the Instrument.
2. Connect the USB 2.0 compliant Cable* to the USB host port of the PC.
3. Connect the other end of the cable in the USB Device port located on the right side of the instrument.
4. Connect the keyboard, monitor and printer to the PC.
5. Connect computer and monitor at the mains power supply or UPS unit.

* The cable for the external connection must not exceed 2 meters in length.

2.5. SOFTWARE – DESIGN AND SPECIFICATIONS

Description and requirements specification

The software used in the equipment 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 permits the connection with any laboratory computer 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 package needed for the correct performance of the instrument comes installed in the PC, ready to be
used.

The application has been developed by applying the EN 62304:2007 standard. This standard establishes a classification
of the software on the basis of its critical nature and potential impact on the patient's health / clinical status.
The class for the overall system software is:

- Class B: non-serious injury is possible

The instrument includes a CPU board which allows the autonomous completion of a run once it has been launched.
This CPU board includes a STM32f4 processor with 8mb SD-RAM, 1mb flash, 1kb EEPROM, micro-SD card for internal
file storage with 8GB (HC1) type 10.

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3. OPERATING PROCEDURE

3.1. BEFORE USING THE INSTRUMENT ................................................................................................................20

3.2. BEFORE PROGRAMMING AN ANALYSIS SESSION ............................................................................................25
3.3. SESSION PROGRAMMING, RUNNING AND RESULTS ........................................................................................25
3.3.1 WASH BUFFER, CLEANING SOLUTION, AND WASTE TANK ...............................................................................25
3.3.1.1 FILL THE WASH BUFFET TANK (5L CAPACITY) ................................................................................................25
3.3.1.2 FILL THE DISTILLED WATER TANK (0.25L CAPACITY)........................................................................................26
3.3.1.3 EMPTY THE WASTE TANK ..........................................................................................................................26
3.3.1.4 EMPTY THE STRIP WASTE CONTAINER..........................................................................................................27
3.3.2. HOME SCREEN .........................................................................................................................................27
3.3.3. RUNNING SCREEN ....................................................................................................................................28
3.3.4. LOAD SAMPLES SCREEN.............................................................................................................................29
3.3.5. WORKLIST SCREEN ...................................................................................................................................31
3.3.6. SHOPPING LIST SCREEN .............................................................................................................................32
3.3.7. LOAD RESOURCES SCREENS........................................................................................................................32
3.3.8. LOAD STRIPS SCREEN ................................................................................................................................34
3.3.9. START THE ANALYSIS .................................................................................................................................37
3.3.10. RUNNING SCREEN ....................................................................................................................................37
3.3.11. CONTINUOUS LOADING .............................................................................................................................38
3.3.12. RESULTS .................................................................................................................................................39
3.3.13. END OF WORK .........................................................................................................................................39

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3.1. BEFORE USING THE INSTRUMENT

General Precautions

The operators 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 prior to using the
instrument. VirClia® Lotus has been designed according to safety protocols for electric devices specified in the certifi-
cations previously mentioned, with the goal of guarantee the correct performance of the instrument, both electrically
and mechanically, under normal conditions of use.

The equipment must be closed and its internal parts inaccessible. When the trial is underway, the equipment must be
closed with all its components not accessible. Never remove the protective covers or the safety components of the
equipment.

The importance of following the instructions stated in this manual must be taken into account, in order to obtain
reliable results from the assays performed in this instrument.

In order to ensure proper use of VirClia Lotus, it is recommended to follow the general precautions 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 person in charge of the instrument must transport or move the equipment, since it contains fragile
material.
• It is not allowed to override the safety and protection devices of the access door (micro switch and electromag-
netic sealing) of VirClia Lotus;

• Do not try to perform repairs or adjustments on VirClia Lotus without first contacting the Vircell S.L. Technical
Service. If the operator does work without authorization, the warranty rights will be lost;

• Do not install any spare parts not provided by Vircell S.L.;

• Do not try to modify the software or the Operating System. The required software and operating system updates
are provided by Vircell S.L.;

• In case of VirClia Lotus malfunction, stop using the instrument and contact the Vircell S.L. Technical Service;

• Before running the tests, consult this User Manual. Keep 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 components approved by the manufacturer.
Equipment design including accessories to be used with the equipment. The instrument is designed to be used
only with reagents established by the manufacturer. Only these reagents should be used to ensure proper equip-
ment operation.

• This manual includes information about operational programs including errors messages and warnings that could
appear during the operational procedure, stated in the section 4 errors and warning messages.

• This manual includes information on inspection, cleaning and control to be done before use, stated in the section
3.1.

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• Only the cleaning tasks indicated in this user manual must be carried out. Before connecting the equipment, make
sure that the mains voltage matches that indicated on the nameplate.

• Avoid direct contact with materials that may be infectious or represent other risks to the human body. Always
wear protective gloves and a lab coat when handling or cleaning equipment. If biological material is spilled on or
inside the instrument, clean it according to sanitary regulations. All material must be disposed of according to the
applicable regulation. Leave a space of at least 20 cm (8 inches) on the back of the machine for proper ventilation.
The instrument requires periodic cleaning and disinfection procedures on the part of the user. Frequency and
mode are indicated in the maintenance section of this manual

• The user must observe the chemical and biological hazard protection regulations, as specified in the health pre-
cautions presented in this User Manual, during handling and loading of samples, controls, specific reagents, cali-
brators and thinners, during the operation of maintenance and during the procedures of decontamination, disin-
fection and disposal of parts of the instrument or instrument as a whole.

• The instructions of the kits with which the machine is used include information about the samples to be used and
the species that interfere.

• Do not use the instrument if it does not work correctly. The contacts of electrical connections (plugs, sockets, etc.)
lead to electrical voltages. All live parts can cause an electric shock, please revise section 3.1 electrical safety. Use
a separate power outlet for the equipment. To reduce the risk of electric shock, never handle the inside of the
equipment without having disconnected it from the power supply.

• Always disconnect the system before proceeding with any maintenance. It is essential to perform the preventive
maintenance actions described to ensure the correct use of the equipment. The maintenance will be carried out
with the equipment disconnected and having allowed the temperature zones to cool down. This manual includes
the importance of proper maintenance stated in section 5 maintenance. In the service manual, periodic mainte-
nance procedures are provided to limit the effects of wear and/or ageing. The risks associated with the improper
maintenance of the instrument have been highlighted in this manual. Periodic maintenance procedures are pro-
vided in the service manual to limit the effects of wear and/or ageing. Dangers for the safety of the user and that
of the patient. Hazards arising from malfunction, maintenance and ageing and contributing factors.

• The team leader must ensure that the ambient light allows the correct lighting of the work areas, both for the
set-up, as for the routines and maintenance. The team leader must ensure that the safety distances around the
equipment are maintained. Position the equipment so that it is not exposed to water or steam.

• Avoid direct exposure to air conditioning.

• Place the equipment so that it is not subjected to extreme conditions of temperature and humidity.

• Position the equipment so that it is not subjected to vibrations or shocks.

• This Manual has defined the limits for installation, operation, transport, storage, placement of the instrument,
known interferences and the use not permitted by the manufacturer (warnings and Precautions) stated in section
2 installation. A specific installation protocol, defined by the manufacturer, has been prepared in the Service
Manual, which provides for a series of calibration, calibration and verification tests to ensure the obtaining of
valid and reliable results for an analysis session.

• When loading the equipment with the sample tubes, act with caution. This manual includes information on the
kinds of tubes to be used in the 3.1 before using the instrument.

• Do not touch the high temperature zones. Contact with these areas could cause burns.

• Weight and dimensions of the instrument are known and reported in this manual in the technical specification
section. Instructions for correct and stable placement are given in this manual in the placement section.

• Do not reuse single use medical devices.

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• The installation guide provides an indication of the risks associated with incorrect storage and the procedures for
verifying and receiving the instrument.

• The instrument must be disposed of in compliance with the national laws in force regarding electrical and elec-
tronic waste. Before disposing of parts or the instrument as a whole, the decontamination and disinfection pro-
cedures provided for in this manual must be carried out, stated in the 3.1 section before using the instrument

Health Precautions

The VirClia Lotus use not excludes the exposure to biohazards. All the parts that come into contact with blood, serum
and other biological liquids, reagents and controls, must be treated as potentially infectious materials.

For safety, follow the directions here below:

• When human samples, specific reagents, controls, calibrators and diluents are handled, protect any cuts, abra-
sions and other skin lesions adequately. Always wear lab coat, disposable gloves, mask and goggles;

• Do not pipette the samples by mouth;

• Do not eat, drink, smoke or apply makeup in the areas where the samples and reagents are handled. Wear goggles
while handling and dispensing the samples, loading the reagents and disposing of the solid and liquid waste.

• Corrosive substances that may cause burns and damage to eyes.

• Always be aware of the risks that these substances may pose. Avoid exposure to corrosive substances.

• Use protective clothing, safety goggles and gloves.

• Always use adequate materials when handling reagents such as VIRCLIA® DECONTAMINATION
SOLUTION, which contains sulphuric acid 0.5M.

Keep in mind that some reagents are potentially hazardous chemicals under the current regulations. The operator
must follow the protection regulations for the chemical and biological hazard in these conditions:
• During the samples, controls, specific reagents, calibrators and diluents handling;

• During the maintenance operations;

• In case of potentially hazardous materials spilling inside the working area of the instrument;

• During the decontamination procedures, disinfection and disposal of the instrument parts or the instrument as
a whole.

• The operator is recommended to carefully read what is specified in the labels on the Monotest Devices boxes
and on the Reagents vials and to keep in mind the indications listed in the Safety Data Sheet of each single kit.

Electric Safety

Vircell S.L. declares that all the internal parts of VirClia Lotus have been designed and implemented to prevent any
electric risk for the operator.

WARNING: The shock hazard exists if the grounding terminal is damaged or disconnected. In case this protection is
damaged or disconnected, do not use the instrument until the grounding terminal restoration.

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• Before any connection, ensure there is a proper grounding terminal.

• Avoid the use of extension or movable cord.

WARNING: All the repairs must be carried out by the VirCell S.L. trained staff. Do not open the electronics board, on
the front left part of the instrument, without having first disconnected the power cords.

WARNING: The Manufacturer doesn’t guarantee the safety and performance requirements in case the VirClia Lotus is
powered with a cord that is compatible with the voltage of the country where the instrument is installed but other
than the one supplied by the manufacturer.
• In case of malfunction or evident damages, disconnect the power cord and contact the Technical service of local
distributor.

• Use the instrument only as described in this Manual of VirClia Lotus. Any use other than the one for what the
instrument is intended, is to be considered improper and can reduce the protection offered by the instrument.

• The Manufacturer cannot be held liable for damages deriving from an improper, incorrect and / or unreasona-
ble use of the instrument or if the instrument is used in electric systems that do not comply with the current
safety regulations of the country where it is installed.

Environmental Requirements

Install VirClia Lotus on a level surface in a place where a constant temperature and a proper level of humidity are
guaranteed. Avoid direct exposure to sunlight. Connect the VirClia Lotus plugs to the power outlets that are grounded.

Supply power VirClia Lotus only with voltages included in those set by the technical characteristics of the instrument.
All these requirements are stated in the technical specification section.

Waste Disposal

Disposable accessories and consumables used and that may be contaminated must be treated as biological waste in
accordance with the procedures established by the Laboratory and collected by a specialized waste manager. All ma-
terials used should be handled and disposed of as potentially infectious. Observe local regulations for the disposal of
clinical waste

Preparation of Sample

Verify that there are no clots, foam or bubbles in the samples prior to runs despite VirClia Lotus can detect their
presence.

NOTE: The information about the preparation of samples, provided in this Manual, is of general nature. The operator
must carefully read the instructions for use contained inside each kit.

WARNING: An improper preparation of samples can lead to false negative results. Samples potentially containing
particles must be centrifuged prior being used.

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Type of samples

VirClia Lotus automatically performs in vitro diagnostics tests on samples such as blood, serum and other biological
fluids.

NOTE: It might be necessary to validate the pipetting of samples with viscosities anomalously high. Consult the Tech-
nical Service for more information.

Storage

The samples must be stored following the instructions given by the manufacturer of the kit.

Identification of samples

VirClia Lotus is equipped with a barcode reader on the external side of the Sample Rotor. The barcoded samples are
identified through the barcode reader. The instructions include the warning not to exchange samples once scanned.

Minimum volume of sample

The minimum volume of sample is the dead volume plus the sample volume necessary to run the assay. Tubes pre-
programed in the VirClia LOTUS software are as stated below:

75mm x 11mm 100mm x 11mm

75mm x 12mm 100mm x 12mm
75mm x 13mm 100mm x 13mm
75mm x 16mm 100mm x 16mm

NOTE: additional tubes exceeding 16 mm of diameter and/or 100 mm high cannot be programmed.

Dead volume

If the sample volume is less than, or equal to, the minimum volume measured by the software it cannot be aspirated
or detected by the pipetting system. The dead volume is < 200 μL for standard test-tubes. This value can be reduced
by using test-tubes with smaller diameters. In this case, the calibration of test-tubes must be performed by technical
staff authorized and trained by VIRCELL S.L.

WARNING: The use of test-tubes different from the ones for which VirClia Lotus was calibrated may lead to false
negative results due to errors in calculating the samples volumes.

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3.2. BEFORE PROGRAMMING AN ANALYSIS SESSION
Before running each session, the following operations must be carried out:

o Turn on the switch on the right side of the instrument;

o Turn on the Computer and make sure all the connections on the workstation are done (printer, mouse,
keyboard and video);
o Make sure the used strips case is empty;
o Make sure the waste tank is empty;
o Make sure the drainpipe is placed into the specific tank or into the centralized drain if available.

3.3. SESSION PROGRAMMING, RUNNING AND RESULTS

3.3.1 WASH BUFFER, CLEANING SOLUTION, AND WASTE TANK

Before to start the PC program make sure that the Wash Buffer Solution has been prepared following the dilution ratio
specified in the IFU.

3.3.1.1 FILL THE WASH BUFFET TANK (5L CAPACITY)

With the prepared solution and connect the tubing:

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3.3.1.2 FILL THE DISTILLED WATER TANK (0.25L CAPACITY)

Fill the distilled water tank and connect the tubing:

3.3.1.3 EMPTY THE WASTE TANK

Take the Tubing with Self-Clutching joint Connect to the Left Side connector

Then press Open Waste, located in the lower taskbar and wait until the liquid stops to flow out from the instrument.

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3.3.1.4 EMPTY THE STRIP WASTE CONTAINER

Then put it back in its position.

Make sure that the orientation of the waste container is correct (please see below):

3.3.2. HOME SCREEN

Once started the Lotus Application Program the above Home Screen will appear.

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Insert the Username and Password and press Log In to access to the Start Page:

There are two ways for initializing VirClia Lotus: Start with Clean or Start Working.
By pressing the Start with clean button the Instrument will execute its initialization procedure that includes:
• Clean of the hydraulic circuit of VirClia Lotus.
• The Reset of all the Moving parts to their Home positions.
• The Strip Rotor and Reaction Rotor checks to detect the presence and position of all the Strip Holders and
find the empty position.
• The hydraulics priming to properly fill all the tubing, dilutors, pumps and needles.
By pressing Start Working, VirClia Lotus will perform the same procedure without the clean of the hydraulic circuit
with DI water.

The status of the Waste Tank level, Wash Buffer Tank Level and Distilled Water Tank level are shown.
Once the initialization is complete the instrument will be ready for the analysis execution. And the Running Screen will
appear.
Refer to paragraph 3.3.1 for the instructions to load the Wash Buffer and the Distilled Water, and to empty the Strip
Waste container and the Waste Tank if needed.

3.3.3. RUNNING SCREEN

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On the Running Screen a schematic representation of the instrument’s layout is displayed.
On the left the Samples Rotor is shown, on the right at the bottom the Strip Loading Rotor is shown, on the top, the
Reaction Rotor. At the right side of the Strip Loading Rotor the Reagent’s Rack is present.

On the Left side of the Screen three information Tabs are displayed:
• Strip rotor Clears in: time needed to have the Strip rotor available to load other strips, at start up its
status is Free.
• Strip Positions available: number of available positions on the Strip Rotor (39 in the empty position is in
the strip rotor/40 if the empty position is in the reaction rotor)
• Next Loading Phase in: time needed to be waited before to be able to load other Samples and/or Strips,
at start-up it is now.
In the Bottom Bar of the program Window there are the buttons that allow to:
• Refill the Wash Buffer Tank: Refill Buffer
• Empty the Waste Tank: Empty Waste
• Perform the Daily Maintenance: Maintenance.
To start the Session Programming press Add Samples.

3.3.4. LOAD SAMPLES SCREEN

The Load Samples screen appears, showing the free positions on the sample rotor where the sample’s tubes can be
placed.

Insert the sample tubes in the available positions with the barcode label facing toward the outside of the rotor (see
picture below).
For each tube the dimensions in the corresponding row of the table must be set, the eligible dimensions could be
selected using the drop-down menu of each row.

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To input the samples codes press Scan to read the sample codes automatically.

After the automatic reading has been executed, a list with all the codes is shown. In case some label in not readable a
red mark is shown in the corresponding position. The user can manually edit the codes of the unread labels.
The empty positions are shown as empty white rows, they are positively identified since the samples rotor brings a
background barcode label that if read signals an empty position.

The user can move along the 50 positions of the list by pressing the up and down buttons.
Once the samples barcode list is properly filled, the user can proceed by pressing the Continue button.

Notice that the codes inserted manually will be signalled with a red colour mark.

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3.3.5. WORKLIST SCREEN

The samples list has been properly filled in the previous screen, now the user can create the Worklist, that means to
link each sample to one or more assays that has to be performed with it.
In this case there are two possible ways to perform this step:
• Manually by clicking on the boxes the user will create the link between the sample code located on one row
with the assay located on one column.

• Automatically by clicking on the “LIS query” button to request the worklist to the laboratory host computer.

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It is possible to replicate one sample row by clicking on the “+” button close to the Sample ID code. In this way the
User can program replicate assays on the samples.
Once all the Samples have been linked to the required assays press continue to proceed.

3.3.6. SHOPPING LIST SCREEN

When all the samples have been assigned with their respective assays (test), the program elaborate the shopping
List, a list of all the Monotest devices needed to execute the analysis session grouped per test type. In this way the
user can know and print if required the type and quantity of Monotest devices boxes required to load them onto the
instrument to start the analysis.

Press Continue to proceed.

3.3.7. LOAD RESOURCES SCREENS

In these screens the program guides the user in the loading of the additional resources needed to execute
the analysis session:
Load Resources Screen 1:

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Decontaminant bottle and additional reagents bottles should be placed onto the Linear Rack on the right side in or-
der to be scanned:

Press Continue to proceed.

Load Resources Screen 2:

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• Diluent bottles, and pre-dilution tubes to be placed onto the sample’s rotor:

• Decontaminant solution bottle can be placed in the upper place sited on the top of the strip rotor in the case
it is needed.

Press Continue to proceed.

3.3.8. LOAD STRIPS SCREEN

Once loaded the resources and after pressing continue the Load Strips Screens appears.

The software guides the user in loading the Monotest Devices (Strips). Each type of Monotest device is represented with
a different color, the color assignment is shown in a table located on the right side of the screen.

There could be more than one load strips page, in each page there are the instructions to load up to ten strips. The colors
assigned to some strip type in one page may be reused for another strip type in another page. The color assignments are
used to help the user to distinguish between the various strip types within each single page.

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Once the Strips of one page have been loaded press continue to proceed to the next page, the strip loading rotor will
move to the next 10 free positions. In the following images you can see the example of a four stages strip loading
procedure with a total of four load strips screens:

Once all the strips have been loaded the final load strip screen appears to ask the user to proceed to scan the strips
barcode reader:

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Press Continue to execute the Strips 2D Barcode reading.

The 2D Barcode Reader is located over the rear side of the Strip Loading Rotor, once all the Strips have been loaded the
software perform a rotor scan to read all the barcodes and check that the strips have been loaded in the assigned
position, this is very important for the proper analysis execution.

Moreover, by reading the barcode of each strip the software can detect if the strip is expired or if it is the wrong strip.
At the end of the scanning cycle if any of the above error conditions is present, it is signaled and the user is requested to
replace the strip or to calibrate the strip lot:

For each wrong strip an error message is displayed and the user is requested to perform an action:
• Resolve: the strip is moved in front of the user to allow its replacement.
• Manual Insertion: a text box is shown and the user can insert manually the code.
•
Once all the strips have been properly replaced/manually edited, press CONTINUE to make the new reading of the codes.

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3.3.9. START THE ANALYSIS

Once all the strips have been properly placed, by pressing the Continue button the assay will start.

Close the Cover and click OK to Start the Analysis.

If the optimal temperature for the assay has not been reached, the temperature on top part of the screen will show
yellow. The assay will start automatically when the optimal temperature is reached, and then it will show green.

3.3.10. RUNNING SCREEN

By clicking OK the program will start the analysis cycle, and the running screen will appear, showing the current position
of the samples and strips.

By clicking on the objects present on the software interface the user can see the details regarding that object (Sample
tube, reagent bottle, monotest device strip, etc.):

The information for a sample tube is displayed in the Figure above. If the sample was identified manually, the software
marks it with a red dot. If the sample is automatically identified, there is no mark. The information displayed for
predilution tubes always includes a red dot.

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The information for a strip is displayed in the above image. If the barcode of the strip is inserted manually, the software
marks the strip with a red dot (right Figure). If the barcode on the strip is detected automatically (left Figure), the
software does not mark (see the Figures below).

3.3.11. CONTINUOUS LOADING

During the running it is possible to add new samples and strips to the session, without the need to stop it. From the
running screen, it is possible to click on the buttons Add Samples or Urgent Sample, the instrument will so receive a
request to access to the sample’s rotor and to the strip rotor. The instrument’s CPU will complete any action it is
performing on one strip, and then will release the cover locking magnets. The program will tell the user that it is possible
to open the cover to load new samples.
The process of sample and Strip loading will be repeated exactly as described above.

Warning!! Do not remove any strip while loading the new ones, since this could reduce the yield of the instrument.

For the urgent samples, the strips related to them, will be processed as soon as possible, while those related to normal
samples, they will be scheduled to be processed after the previously loaded samples.

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3.3.12. RESULTS
Once each strip has completed its analysis process the result is calculated and stored into a file located in the program
folder. Moreover, if the LIS connection is active the results are transferred to the host computer of the laboratory.
Finally, if a printer has been connected to the PC and configured in the service menu, the results will also be printed out.

3.3.13. END OF WORK

At the end of the day, when all the analysis sessions have been completed, the user must put 0.25L of distilled water in
the proper tank (see Fig.1.4-02) and perform Maintenance, by clicking on the button in the running screen bottom.

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4. ERRORS & WARNING MESSAGES

4.1 SAMPLE OR REAGENT LIQUID LEVEL DETECTION FAILURE..................................................................................41

4.2 WASH BUFFER LOW VOLUME ....................................................................................................................42
4.2.1. BEFORE USING THE INSTRUMENT ................................................................................................................42
4.2.2. WASH BUFFER EMPTY ..................................................................................................................................43
4.3 WASTE TANK HIGH LEVEL..........................................................................................................................43
4.5 STRIP WASTE CONTAINER FULL ..................................................................................................................44
4.6 MOTOR OR HARDWARE ERROR ..................................................................................................................45

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During the exam execution the instrument software continuously monitors all the activities performed by the various
motors actuators and pumps, by means of specific sensors.
In case some warning or error condition are detected, a message box is displayed and the user is requested to perform
some action to manage the situation Furthermore, the frontal LED will blink showing different colors depending of the
situation in which the instrument is:
o Blue: Normal status
o Yellow: Warning status
o Red: Error status

4.1 SAMPLE OR REAGENT LIQUID LEVEL DETECTION FAILURE

The sample needle and the reagents needle are able to detect the liquid inside the samples tubes or into the reagents
bottles. If before aspirating from one of the containers the liquid level is not detected the following message box is
displayed:

The user is requested to perform one of the following actions:

Retry: Repeat the automatic level detection.

Aspirate from the Bottom: Force the instrument to aspirate the liquid from the bottom of the
container. Press this option only if you are sure that there is enough
liquid inside the tube or bottle.
Inspect: It is to request the instrument to unlock the lid and allow to open it to
inspect the container and decide which action can be executed. Once
the user is able to access the container it will be possible to properly
refill it, before to issue the Retry command.

- Pay attention to pick the proper liquid to refill the container, do

not mix different liquids, i.e. samples and reagents!!
Invalidate: To skip that container: this will also invalidate the programmed assays
that requires that liquid.

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4.2 WASH BUFFER LOW VOLUME

4.2.1. BEFORE USING THE INSTRUMENT

The wash buffer tank volume is continuously monitored. When the liquid is below the total volume that the software
estimates that is needed to perform the assay, a warning message is displayed:

The user is requested to perform the following actions:

Refill: Request to the system to pause to allow the wash tank refill. The
system will tell the time to be waited before to safely access to
the buffer tank.

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4.2.2. WASH BUFFER EMPTY
The wash buffer tank volume is continuously monitored, when it goes under the 5% of the total available volume an
Alert message is displayed:

The user is requested to perform the following actions:

Refill: System is paused, waiting for the buffer refill, press refill to allow the system to restart
working.
Attention: in case the refill is delayed too much, some of the tests could be aborted!

4.3 WASTE TANK HIGH LEVEL

The waste tank volume is continuously monitored, when it goes over the 60% of the total available volume a warning
message is displayed:

The user is requested to perform the following actions:

Empty: Press empty to issue a request to the system to empty the waste tank.

Before the waste tank is full, the instrument will stop working and the a warning message will be displayed:

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The user is requested to perform the following actions:

Empty: Press empty to empty the waste tank.

Attention: in case of the waste tank being full, some of the tests could be aborted!

4.4 STRIP WASTE CONTAINER FULL

The strip waste container residual capacity is calculated after each strip disposal, when the number of discarded strips
exceed the maximum, the system stops discarding the other Strips that will remain on the reaction rotor until the
container is emptied and a warning message is displayed:

The user is requested to perform the following actions:

Empty: Press empty to issue a request to the system to empty the strip waste container
Attention: if the strip waste container reaches the maximum capacity the yield of the
instrument will be reduced.

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4.5 MOTOR OR HARDWARE ERROR

All the movements and hydraulics activity are continuously monitored. If any failure occurs during the exam process
an alert window will be displayed and the user may be requested to perform some basic check before to call the
technical service, see the example below:

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5. MAINTENANCE

5. MAINTENANCE ................................................................................................................................... 46
5.1. GENERAL RULES ......................................................................................................................................... 47
5.2. RESPONSIBILITIES ........................................................................................................................................ 47
5.3. DAILY MAINTENANCE PROCEDURE ................................................................................................................ 47
5.4. WEEKLY MAINTENANCE PROCEDURE ........................................................................................................... 488
5.5 MONTHLY MAINTENANCE PROCEDURE ......................................................................................................... 49

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5.1. GENERAL RULES

WARNING: In case of improper maintenance, VirClia Lotus can work incorrectly.
Before carrying out maintenance procedures on the instrument, make sure that:
• The working area is clean and free from any resources left from the previous session;
• The possible spills in the working area have been immediately cleaned with water and dried.

Continual inspection of VirClia Lotus is to ensure that the system works properly.
All the materials, used during a session, must be disposed of in accordance with the local safety regulations.
In case of a system malfunction, or breakage of any parts, the repair or replacement of the damaged part must be car-
ried out by the technical staff authorized and trained by Vircell S.L..

5.2. RESPONSIBILITIES
In case of a system malfunction or breakage of any parts, the Technical Service staff must intervene promptly. The daily
and weekly maintenance procedures must be carried out by the operator. Long-time instrument maintenance will also
be performed by the Technical Service.

5.3. DAILY MAINTENANCE PROCEDURE

Daily maintenance includes startup and shutdown steps. Startup steps are performed prior to the first run of the day and
shutdown steps are performed following the last run of the day.

• Daily Startup: it consists of a priming of the hydraulic system with wash buffer in order to remove the distilled water
that is inside the tubing system.
How to carry it out? After starting the Lotus software, and logging in, the software asks the user to:

A) Start with Clean: this option primes first with distilled water, and then with wash buffer. It is recommended only
if the end of the day maintenance was omitted the previous day (i.e. the instrument was working overnight).
B) Start Working: this is the option that needs to be used regularly. After clicking on it, the instrument will prime
with wash buffer.

• Daily Shutdown:
a) Maintenance: after having finished the daily work, and before shutting down the instrument, it needs to be
primed with distilled water. To do so, click on the “Maintenance” button in the running screen bottom:

When trying to close the software, the user will be reminded to perform the end of the day maintenance, which
will be possible to perform it through this pop-up window.

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b) Close the reagent’s vials. Store at 4ºC those that require it.
c) Empty the external waste container. When reconnecting the tube, make sure that it is straight and free of folds,
as this can hinder the emptying of the internal waste tank.
d) Empty the strips waste container.
e) Shut down instrument and computer.

Note: any spillage over the working surface should be cleaned immediately.

5.4. WEEKLY MAINTENANCE PROCEDURE

The weekly maintenance is a very straightforward and easy procedure, which includes cleaning steps that are to be per-
formed approximately every seven days. It is recommended that the same day of the week be used for consistency. Care
should be taken to ensure that no excess liquid comes into contact with the instrument surfaces while cleaning.

The aim of the weekly maintenance is to avoid adsorption of proteins as well as the contamination of the instrument by
environmental microorganisms.

Weekly Maintenance steps should be performed as follows:

• Gently clean the probe with an alcohol wipe.

• Clean the strip waste container: inside the container there are rests of samples and therefore there can be
contact with biohazardous materials. Using gloves, empty the container and clean the inner part using a hypo-
chlorite dilution. Afterward, rinse the container with water and leave it to dry out.

• Prepare 1 L of disinfecting detergent. Vircell has evaluated and recommends the product Mucocit T at 4%.
Using gloves and other protective measures indicated in the Safety Data Sheet of the product, prepare 1 L of
Mucocit T at 4%; add 40 ml of concentrated Mucocit T and complete with water to 1 L. Prepare it extemporane-
ously or use a preparation with less than 2 weeks from reconstitution date (it expires in 2 weeks once it is recon-
stituted).
• Prime the instrument with Mucocit T:

o From the 1 L dilution at 4%, add 100 ml to the spare 0.25L bottle provided with the instrument. We
recommend to label it as follows so it can be easily identified and used in the future for the same pur-
pose:

o Remove the 0.25L DI Water bottle from the instrument and discard its content. Then, attach the 0.25L
bottle containing the Mucocit T.
o Prime the instrument with Mucocit T at 4%. To do so, click on the “Maintenance” button located in the
tools tab at the bottom of the screen:

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o Leave the disinfecting detergent inside the instrument for 5-10 minutes.
o Afterwards, remove the 0.25L bottle containing the Mucocit T, add fresh DI Water to the 0.25L DI Water
bottle and reattach it. Prime two times with DI water in order to remove the detergent from inside the
fluidics system. To do so, use two times the “Maintenance” button.

• After having primed the instrument with DI Water to remove the Mucocit T, take out the DI Water bottle again,
empty it and leave it drying until next use. This will help to avoid contamination in the bottle.

• Disinfect the wash buffer tank*:

o Remove the wash buffer tank from the instrument and discard its content.
o Fill the tank with the remaining 900 ml of Mucocit T at 4%. Gently move its content so it enters in contact
with all the surfaces of the tank. Do not shake vigorously, to avoid creating too much foam. Leave the
solution acting inside for 5-10 minutes and then rinse the tank with water thoroughly.

• Clean the working area with a humid cloth. Avoid cleaning plastic surfaces with aggressive solvents. Plastic sur-
faces should be cleaned with a humid cloth.

*Alternative to the disinfection of wash buffer tank:

• Take a sample from the wash buffer tank weekly and culture it in a generic medium (Blood Agar, TSA) for 48
hours. After 48 hours, if the count is higher than 100 CFU/ml, the disinfection has to be carried out as explained
above. If it is negative, the disinfection of the wash tank can be skipped.

5.5. MONTHLY MAINTENANCE PROCEDURE

• Clean the external waste tank with a hypochlorite solution.
• Clean the sample rotor:
o Clean the surface of the rotor with a humid cloth if there is dirtiness (dry liquids, scales, dust).
o Clean underneath the sample rotor if there is dirtiness. To do so, with one hand, hold the rotor and with
the other hand unscrew the rotor bolt:

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 Operator’s Manual

Maintenance
o In this way you can access the area underneath the sample rotor:

o To place the rotor back, there are 2 pins below and 2 holes in the bottom part of the rotor. To be able to
correctly reattach the sample rotor, the 2 pins have to fit in the 2 holes:

o Once the rotor has fit, screw the rotor bolt.

Note: if the wash tank has not been disinfected weekly because samples were taken and cultured in a generic medium,
and there was no growth, it has to be disinfected monthly, following the indications explained in the weekly mainte-
nance.

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