Vircell 30006590, Руководство пользователя

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Operator’s Manual
Operating Procedure
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1.3. I
NTENDED
U
SE
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. G
ENERAL
D
ESCRIPTION
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.