BD Kiestra ReadA - Introduction; Intended use; Module startup; Module description

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2 Introduction
2.1 Intended use
The BDKiestra™ ReadA is an in-vitro diagnostic device system which consists of an incubator
and a camera module. The ReadA is used to incubate plates and to create images of plates.
Plates are automatically removed from the incubator, photographed, and returned to the
incubator or transported to another specified destination.
The BDKiestra™ ReadAis indicated for use in the clinical laboratory.
WARNING
WEAR PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES, SAFETY
GLASSES) WHEN INTERACTING WITH THE MODULE.
2.2 Module startup
The BDKiestra™Track module provides electrical power to the BDKiestra™ReadA module
and must be powered on before trying to startup ReadA. Refer to the BDKiestra™ Track
User's Manual for details on turning on Track.
When power is applied to the ReadA module, the following operations are performed:
l
Hardware is checked and initialized.
l
Various sensors and subsystems are verified.
The module reports any problems that require user attention through alerts. If anything arises
that would prevent proper operation, the startup process is canceled.
BD recommends that the module remain powered on at all times except during certain
maintenance procedures.
2.3 Module description
This section describes the ReadA components, general flow of plates in and out of the ReadA
module, and the ReadA software application.
2.3.1 BDKiestra™ ReadA incubator
Plates are stored in racks at predefined incubation conditions in the ReadA incubator.
The ReadA incubator should remain turned on at all times to ensure specimen integrity.
2.3.1.1 Audible alerts and visual indicators
Each ReadA contains an audible alert, which is used to inform the user if a warning or error
situation has occurred within the module.
The user can also refer to the ReadA application via the Track graphical user interface (GUI),
or the instrument status tile on one of the dashboards in the BDSynapsys™ Informatics
Solution, for visual status indicators. Refer to the BDSynapsys™ Informatics instructions for
use for more details regarding the dashboards and viewing an instrument status.