1 – Introduction
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1.3 System Overview
The BD BACTEC™ FX40 instrument provides the following major features:
• Modular instrument design permits flexibility
to accommodate laboratory needs
• Graphical user interface with color displa
y and touchscreen provides ease of use
• Real-time vial presence sensors located in each
vial station provide immediate feedback on
vial insertion and removal from stations
• The ability to mix bacterial, fungal, and
mycobacterial cultures within a module or system is
accomplished by varying the medium type
• Can be connected to a compatible Laboratory Information System (LIS)
• Can be connected to BD EpiCenter™ system
1.3.1 Instrument Overview
The BD BACTEC™ FX40 instrument is an automated system for detecting the presence of
microorganisms in clinical samples, blood, and blood products. Inoculated vials are placed in the
instrument vial stations. When the door is closed, vials are monitored for microbial metabolic activity
over time by measuring the fluorescence levels from a specially designed sensor in the vial. This is
performed by the measurement subsystem. The algorithm subsystem analyzes the signals from the
measurement subsystem to determine if evidence of microbial growth (i.e. positivity) is present.
Agitation is performed by the agitation subsystem, which supports organism growth. Data storage and
examination is managed through a data management subsystem. Stations are rendered unusable due
to an alert condition such as an incubation failure, agitation failure, or measurement system failure.
The user interface subsystem encompasses all instrument functions
pertaining to instrument workflow,
primarily inserting vials into the instrument for testing, and subsequent removal of positive and final
negative vials. Demographic information can be entered into the system and reported out. Vial
information can be entered via a barcode reader, designed for one-handed operation, or can be entered
manually via an onscreen keyboard. Vials are associated to a particular station by the process of
inserting the vial into a station immediately after scanning the vial; this activates the station’s vial
presence sensor. You can view information about vials processed by the instrument, request printed
reports, or communicate with a BD EpiCenter™ system. Indicator LEDs on the front of the instrument
and others above each station convey status information. The instrument provides confirmatory audio
and visual feedback at the completion of each workflow transaction.
From 1 to 4 BD BACTEC™ FX40 instruments can
be connected to a single tablet PC and can share a
printer and barcode reader. This cluster can be linked to a BD EpiCenter™ system to create a larger
installation with full connectivity between BD BACTEC™ FX40 clusters and BD BACTEC™ FX
instruments.
Figure 1-2 – BD BACTEC™ FX40 Instrument