Virtuo Ingles

® ®
BACT/ALERT VIRTUO
Microbial Detection
System User Manual
050574-02 - en - 2022-08 -
EN
IVD
Table of Contents
Introduction to the System.....................................................................................1-1

Intended Use and Users.............................................................................................. 1-1
Instrument Training........................................................................................... 1-1
Intended Use.....................................................................................................1-1
Benefits of Use.............................................................................................................1-2
General Statements..................................................................................................... 1-3
Standard Symbols........................................................................................................1-5
Safety Information...................................................................................................2-1
System Compliance..................................................................................................... 2-1
Electrical Warnings...................................................................................................... 2-1
Electrical Grounding..........................................................................................2-2
Electrical and Electronic Recycling................................................................... 2-3
USB Devices................................................................................................................2-3
Instrument Labels........................................................................................................ 2-4
Safety Precautions.....................................................................................................2-12
System Overview.................................................................................................... 3-1

Introduction to BACT/ALERT® VIRTUO®................................................................... 3-1
Instrument Configuration...................................................................................3-1
System Configuration........................................................................................3-1
Data Management.............................................................................................3-6
Reagents......................................................................................................................3-6
Bottles Supported for Use................................................................................. 3-6
Bottles Not Supported for Use.......................................................................... 3-7
Additional Supplies...................................................................................................... 3-7
System Temperature Guidance................................................................................... 3-8
Theory of Operation..................................................................................................... 3-8
Principle of Detection........................................................................................ 3-8
BACT/ALERT® VIRTUO® Hardware.......................................................................... 3-9
B Unit.............................................................................................................. 3-16
General Instrument Specifications............................................................................. 3-19
Physical Characteristics.................................................................................. 3-19
Environmental Characteristics........................................................................ 3-21
BACT/ALERT® VIRTUO® Screens............................................................................3-21
Large Display.................................................................................................. 3-21
Small Display.................................................................................................. 3-22
Common Screen Elements............................................................................. 3-24
System Installation and Setup............................................................................... 4-1

Setting the Date and Time........................................................................................... 4-1
Windows Environment................................................................................................. 4-2
Installing Windows® Security Updates..............................................................4-2
Basic Functions...................................................................................................... 5-1

Introduction.................................................................................................................. 5-1
Monitoring the System................................................................................................. 5-1
Home Screen.................................................................................................... 5-1
Display Bank Screen.........................................................................................5-5
System Log In.............................................................................................................. 5-5
Logging in to BACT/ALERT® VIRTUO®...................................................................... 5-6
Inactivity Timeout......................................................................................................... 5-6
050574-02 i BACT/ALERT® VIRTUO®

Table of Contents
Applying a Barcode Label to a Bottle...........................................................................5-6

Loading Bottles Automatically....................................................................................5-10
Unloading Bottles Automatically................................................................................ 5-13
Unloading Positive Bottles Automatically........................................................ 5-14
Unloading Negative Bottles Automatically...................................................... 5-15
Canceling a Bottle Test................................................................................... 5-15
Handling Unconfirmed Positive Bottles........................................................... 5-16
Unloading Bottles by User Request........................................................................... 5-16
Unloading Positive and Negative Bottles by User Request............................ 5-17
Unloading Specific Bottles by User Request...................................................5-18
Canceling the Bottle Unload Request............................................................. 5-18
Managing Bottle Information...................................................................................... 5-18
Data Retention Period for Bottle Information.................................................. 5-18
Searching for Specific Bottle Information........................................................ 5-19
Search Results Screen................................................................................... 5-29
Accessing the Bottle Status Information Screen............................................. 5-30
Editing a Bottle Record................................................................................... 5-32
Processing Expired Bottles............................................................................. 5-36
Reloading Positive Bottles.............................................................................. 5-37
Identifying an Anonymous Bottle............................................................................... 5-38
Identifying an Anonymous Bottle with a Visible bioMérieux Label.................. 5-38
Identifying an Anonymous Bottle without a Visible bioMérieux Label............. 5-39
Unloading, Relabeling, and Reloading a Previously Identified Anonymous Bottle.... 5-41
Alternate Bottle IDs.................................................................................................... 5-42
Viewing and Printing a Bottle Label Image................................................................ 5-43
Zooming and Rotating a Bottle Label Image..............................................................5-43
Viewing and Printing Records for Unloaded Bottles.................................................. 5-44
Viewing a Bottle Graph.............................................................................................. 5-44
Viewing and Printing Reports.....................................................................................5-45
Bottle Reports................................................................................................. 5-46
Instrument Reports..........................................................................................5-52
Capacity of the Waste Container............................................................................... 5-58
Emptying the Waste Container.................................................................................. 5-58
System Configuration.............................................................................................6-1
Accessing the Configuration Screens.......................................................................... 6-2
Configuring Bottle Type Settings..................................................................................6-3
Configuring the Maximum Test Time.................................................................6-4
Sample Volume Measurement..........................................................................6-5
Sample Volume Variation..................................................................................6-5
Setting the Sample Lower Variation..................................................................6-6
Setting the Sample Upper Variation..................................................................6-7
Configuring Bank Settings........................................................................................... 6-7
Naming Instruments.......................................................................................... 6-8
Naming Banks and Labs................................................................................... 6-8
Configuring the Bank Near Full Threshold........................................................ 6-8
Configuring the Incubation Temperature Set Point........................................... 6-8
Configuring the Waste Near Full Threshold...................................................... 6-9
Configuring the Maximum Allowable Time in Retrieval Area............................ 6-9
Configuring Sound Settings............................................................................ 6-10
Configuring Alarm Settings..............................................................................6-11
Configuring General Software Settings...........................................................6-13
Configuring Security Settings..........................................................................6-17
Configuring LIS Settings (standalone configuration only)............................... 6-20
Configuring Bottle Report Settings..................................................................6-22
Managing User Accounts and User Groups.............................................................. 6-24
Accessing the User Management................................................................... 6-24
Password Policy..............................................................................................6-24
050574-02 ii BACT/ALERT® VIRTUO®

Table of Contents
Defining User Identification Data.....................................................................6-24

Assigning User Rights.....................................................................................6-26
Modifying User Identification Data.................................................................. 6-26
Removing a User from a Group...................................................................... 6-27
Disabling a User Account................................................................................6-27
Re-enabling a User Account........................................................................... 6-28
Unlocking a User Account...............................................................................6-28
Deleting a User Account................................................................................. 6-29
Configuring Extenal Users in User Management............................................ 6-29
User and Group Functions.............................................................................. 6-30
Emergency Manual Bottle Loading and Unloading............................................. 7-1

Emergency Manual Unloading Positive Bottles........................................................... 7-3
Emergency Manual Loading Bottles............................................................................ 7-5
Discrepancy in the Manually Loaded Bottle Count......................................... 7-12
Anonymous Bottle Alert after Manual Loading................................................7-12
Emergency Manual Unloading Anonymous Bottles...................................................7-13
Emergency Manual Load Worksheet.........................................................................7-16
Troubleshooting...................................................................................................... 8-1
Resolving Alarms and Alerts........................................................................................8-1
Viewing Alarms and Alerts................................................................................ 8-1
Alarm and Alert Causes and Resolutions......................................................... 8-2
Loading Bottles across a Bank........................................................................8-23
Opening the Instrument for Internal Access....................................................8-24
Closing the Door............................................................................................. 8-29
Unjamming the Robot..................................................................................... 8-32
Audit Trail...................................................................................................................8-35
Accessing the Audit Trail.................................................................................8-35
Audit Trail for Standalone and Site Configuration (MAESTRIA™).................. 8-36
Audit Trail for Site Configuration (MYLA®)...................................................... 8-39
Viewing/Printing Saved Audit on an External PC............................................8-42
Collect Logs............................................................................................................... 8-43
Generating the Log File...................................................................................8-43
Notification Center (Standalone Configuration only)..................................................8-45
Configuring the Notification Center for BACT/ALERT® VIRTUO® Events......8-46
Best Practices for Preventing False Positives..................................................... 9-1

Preventing False Positives - User................................................................................9-1
High Amount of White Blood Cells ................................................................... 9-1
Blood or Sample Volume Too High................................................................... 9-2
Large Bottle Loading and Unloading Events.....................................................9-2
Temperature Changes in the Environment....................................................... 9-2
Bottle Not Completely Loaded into the Cell...................................................... 9-4
Preventing False Positives - Instrument...................................................................... 9-4
Cell Noise..........................................................................................................9-4
High Initial-Value Readings...............................................................................9-5
Troubleshooting False Positive Preparation................................................................ 9-6
Performing System Maintenance........................................................................ 10-1

Rebooting the Instrument (Small Display)................................................................. 10-1
Rebooting the Internal PC (Large Display)..................................................... 10-1
Starting Up the Instrument......................................................................................... 10-2
Restoring Data........................................................................................................... 10-2
Automated Backups...................................................................................................10-3
Scheduling Automated Backups................................................................................ 10-3
050574-02 iii BACT/ALERT® VIRTUO®

Table of Contents
Configuring the Backup..............................................................................................10-4

Performing a Manual Data Backup............................................................................ 10-4
Disinfection Procedures............................................................................................. 10-6
Bottle Leaks.................................................................................................... 10-6
Approved Disinfection Agents......................................................................... 10-6
Cleaning a Spill .............................................................................................. 10-7
Cleaning the Robot Gripper Pads.............................................................................. 10-9
Cleaning the Conveyor.............................................................................................. 10-9
Outer Instrument Panels.......................................................................................... 10-10
Removing a Bottle Rack Cover Plate.......................................................................10-10
Cleaning the Rack Cover Plate................................................................................10-10
Cleaning the Bottle Racks........................................................................................10-12
Disinfecting for Mycobacteria Contaminants............................................................10-13
Decommissioning BACT/ALERT® VIRTUO®.......................................................... 10-13
Revision History
050574-02 iv BACT/ALERT® VIRTUO®

General Information
The content of this document is based on the software release 3.1.
Please discard any previous copies of this document if relevant.
This document may contain information or references relating to certain bioMérieux products,
software or services which are not available in the country of release; this shall not mean that
bioMérieux intends to market such products, software or services in such country.
To request copies of publications or for any technical request / assistance, contact bioMérieux
or your local distributor (contact information available on www.biomerieux.com).
Note: The screens and figures shown are intended as illustrations only and must not be interpreted
as actual representations of data, results or equipment.
Screens and equipment are not shown to scale.
IMPORTANT: Please read this document carefully before using the system.
For users in the European Union (Regulation (EU) 2017/746) and in countries with similar
requirements: Should a serious incident occur during the use of this device or as a result of its
use, please report it to the manufacturer and/or their authorized representative as well as to
your national authority.
Warning and Safety Messages
The user documentation uses several types of statements to alert you to important
information. Important information is labeled in text and identified using symbols.
Statement Types
The statement types are Warning, Caution, Important, and Note. The following examples
define each statement type. The general caution symbol is used in these examples, but other
symbols (see Standard Symbols) may be used instead.
The warning messages in this document mainly refer to:
WARNING
A Warning statement alerts the user to the possibility of injury, death, or
other serious adverse reactions associated with the use or misuse of the
device.
CAUTION: A Caution statement alerts the user to the possibility of a problem

with the device associated with its use or misuse. Such problems include
device malfunction, device failure, damage to the device, or damage to other
property. Where applicable, a Caution statement may include a precaution
that should be taken to avoid the hazard.
IMPORTANT: An Important statement relates to content presented in the user documentation. It is
used to reinforce the user’s understanding of selected information.
Note: A Note statement supplies additional information about a topic.
Intellectual Property
BIOMERIEUX, the BIOMERIEUX logo, BACT/ALERT, VIRTUO, MYLA, MAESTRIA, and

VILINK are used, pending and/or registered trademarks belonging to bioMérieux, or one of its
subsidiaries, or one of its companies.
Any other name or trademark is the property of its respective owner.
The VIRTUO product may be protected by one or more patents. See Virtual Patent Marking.
© 2022 bioMérieux, Inc. All rights reserved
Limited Warranty
bioMérieux warrants the performance of the product for its stated intended use provided that
all procedures for usage, storage and handling, shelf life (when applicable), and precautions
are strictly followed as detailed in the instructions for use (IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any
implied warranties of merchantability and fitness for a particular purpose or use, and disclaims
all liability, whether direct, indirect or consequential, for any use of the reagent, software,
instrument and disposables (the "System") other than as set forth in the IFU.
Customer acknowledges and agrees that use of the System for testing of sample types or for
indications other than those described in the IFU is done solely at the Customer’s own risk.
Customer acknowledges and agrees that it is Customer’s sole and exclusive responsibility to
validate the System for any such intended use, and to determine whether the System is
suitable for that intended use. The performance of any validation studies and the subsequent
use of the System based on Customer’s validation studies shall be the Customer’s sole risk
and responsibility.
Product warranty details can be obtained from bioMérieux or your local distributor (contact
information available on www.biomerieux.com).
1 Introduction to the System
Intended Use and Users
BACT/ALERT® VIRTUO® Microbial Detection System and this manual are intended for
laboratory users who are trained in microbiology and good laboratory practices.
WARNING
A potential hazard (false negative test results) may occur if unqualified users
operate the instrument.
Instrument Training
Users should be trained on the system by qualified bioMérieux personnel before
implementing the instrument in their laboratory. This training will include all functions required
to operate the system including accessing the software, daily workflow tasks such as bottle
loading and unloading, and resolving instrument alarms and alerts. Contact your local
bioMérieux representative to schedule training. Retraining may be required following any
instrument update, depending on the specific changes included in the update.
Intended Use
BACT/ALERT® VIRTUO® Microbial Detection System is an automated microbial test system
capable of incubating, agitating, and continuously monitoring for the detection of aerobic,
facultative, and anaerobic microorganism growth from blood and other normally sterile body
fluids and from blood platelet samples.
In blood bank facilities, the BACT/ALERT® VIRTUO® Microbial Detection System will provide
in-process testing for the presence or absence of microorganisms.
050574-02 1-1 BACT/ALERT® VIRTUO®

Benefits of Use Introduction to the System
CAUTION: bioMérieux shall not be liable as to any defect (including, but not
limited to, incorrect results that may affect patient outcomes) from these
conditions:
• Abuse of the instrument
• Failure to operate and maintain the instrument in accordance with the
User Manual
• Operation of the instrument by a person who has not been trained in its
operation by bioMérieux
• Repair, service, alteration, or modification of the instrument by any person
other than service personnel of bioMérieux
• Modification, change or reuse of the disposables supplied by bioMérieux
for use in the instrument
• Use of disposables (bottles) other than those supplied by bioMérieux
• Use of disposables beyond the expiration date indicated on the label
• Reuse of bottles. Never reuse bottles for multiple patients or samples.
WARNING
The consequences of reusing bottles may be incorrect results
since using bottles for multiple patients or samples is
contradictory to the intended use of the system. See the
Instructions for Use for BACT/ALERT® bottles.
CAUTION: BACT/ALERT® VIRTUO® is marketed for use in the detection of

microorganisms in blood and other normally sterile body fluids. Customers
who use the instrument in testing of sample types or for indications other
than those described in the applicable blood culture bottle instructions for
use (IFU) and user information do so at their own risk. Performance
characteristics for the instrument for any use outside the labeling, package
insert, or user manual have not been established.
Benefits of Use
The BACT/ALERT® VIRTUO® instrument is a continuous monitoring blood culture system.

Once bottles are placed into the incubator, they are checked for microbial growth continuously
by the instrument with no operator intervention. The benefits of using this system include:
• Continuous agitation and incubation that reduces time-to-detection, which means faster
results for the patient
• Automated loading of bottles, which saves time and standardizes the workflow
• Automated disposal of negative bottles, reducing the lab technician's exposure to
biohazardous waste and saving time.

General Statements Introduction to the System
General Statements
This section provides important statements that apply to all products. Equipment meets the
requirements and standards stated in the certificate supplied with it.
WARNING
Equipment is intended for professional use only.
Laboratory personnel should be qualified and adhere to the principles of
good laboratory practice.
All the user documents supplied must be read prior to use of the equipment.
Under no circumstance should the user dismantle equipment due to the risk
of touching dangerous parts, including parts that may be infectious or
connected to a source of electric power.
Do not obstruct the equipment and hardware ventilation apertures, and leave
sufficient clearance around the equipment for the circulation of air.
All biological materials should be considered as potentially infectious.
Suitable individual protective equipment is required when handling chemical
or biological substances.
bioMérieux is in no case liable for the harmful consequences of incorrect use
or improper handling of these substances.
WARNING
Electromagnetic Compatibility (EMC):
The EMC class of the equipment is indicated on the certificate supplied with
it.
If equipment is a class A product, it may cause radio interference in a
domestic environment, in which case the user will be required to correct the
interference at his own expense.
Do not use this device near strong sources of electromagnetic radiation (for
example, intentionally unprotected radio-electric sources), which could
interfere with the operation of the equipment.
It is recommended to evaluate the electromagnetic environment before
starting the device.

General Statements Introduction to the System
WARNING
In order to avoid computer viruses or abnormal functioning of your
equipment, never download any software other than those ensuring the
protection of your network and those provided or recommended by
bioMérieux.
It is your responsibility to secure your network and ensure this protection is
appropriate and maintained. It is recommended to use all appropriate means
(including antivirus software, security patches, firewall) to protect your
network from virus intrusion, unauthorized use, alteration, manipulation and
disclosure.
In an effort to reduce the risk of spreading a virus to bioMérieux equipment,
it is recommended that only bioMérieux supplied USB devices are used with
bioMérieux equipment. The use of personal USB devices is not
recommended. To avoid computer viruses and the potential loss of
functionality and/or results, use caution when transferring USB devices
between computers. Do not use USB devices intended for bioMérieux
equipment in other computers that do not have current antivirus software
installed and active.
All computer media (CD, DVD, USB key) supplied with this equipment should
be stored and stocked in a suitable location.
Only modify the software configuration parameters you are authorized to
modify and which are described in the user documentation.
WARNING
Decontamination of equipment at the end of its life cycle:
The following instructions must be followed by all users in countries where
local legislation imposes the treatment and recycling of equipment at the end
of its life cycle.
As a general rule, and as a precautionary measure, any part of the equipment
(including sub-assemblies, components and materials) considered to be
potentially infectious, must be decontaminated, whenever possible, or
removed if decontamination is impossible or presents a risk.
Any part considered to be potentially infectious, which is not
decontaminated, must be removed from the instrument before following the
normal channels for elimination of infectious products, in accordance with
local regulations.
The decontamination instructions in the user documentation correspond to
the parts of the equipment that are potentially infectious according to their
intended use. These operations must be performed before the equipment is
transferred to a third party.
However, bioMérieux cannot exclude that other parts of the equipment have
not been contaminated in other circumstances, in particular as the result of
spillage of infectious substances. In this case, the user is solely responsible
for decontaminating these parts or removing them before they follow the
normal channels for elimination of infectious products.

Standard Symbols Introduction to the System
WARNING
This statement only applies to European countries with regard to the waste
electrical and electronic equipment European directive:
You can play an important role in contributing to reuse, recycling, and other
forms of recovery of waste electrical and electronic equipment. Sorting this
type of waste significantly reduces potential negative effects on the
environment and human health as a result of the presence of hazardous
substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of the product as
unsorted municipal waste, even if it is decontaminated. It is imperative that
you contact bioMérieux to assure its appropriate disposal.
IMPORTANT: Electrical or other connections should only be made using the accessories supplied
with the equipment.
IMPORTANT: It is important to follow all the restrictions on use, particularly concerning

temperature, storage, installation and voltage, which are indicated on the product
label or in the user documentation.
IMPORTANT: The accuracy of results obtained with this equipment depends on the maintenance
operations described in the user documentation (user maintenance and/or periodic
preventive maintenance performed by bioMérieux).
IMPORTANT: The user should be aware that if the maintenance operations are not performed, are
only partially performed, or are not performed as described in the user
documentation, bioMérieux is in no case liable for any false test results obtained.
IMPORTANT: It is recommended to keep the original packaging materials in case the equipment
needs to be moved. Any damage directly or indirectly resulting from the transport of
the equipment without adequate containers will not be covered by the warranty.
Standard Symbols
The following table defines symbols that may appear in the instructions for use or on the
instrument, package inserts, or packaging. When surrounded by a triangle on a yellow
background, the symbol highlights an immediate warning and is positioned on the instrument
itself.
Compliance with US and Canadian

CE-Marking of Conformity
Safety Standards certified by CSA

Compliance with China RoHS

UL Listed to US and Canadian Safety
Regulation (Chinese Standard SJ/
Standards
T11364)
In Vitro Diagnostic Medical Device Batch code
Authorized Representative in the

Catalogue number
European Community
Serial number Consult Instructions for Use
Use by date Manufacturer
Date of manufacture This way up
Caution, consult accompanying

Do not stack
documents
Contains sufficient for <n> tests Do not reuse
Keep dry Keep away from light
Fragile, handle with care Humidity limitation
Keep away from magnetic field Temperature limitations
Upper limit of temperature Lower limit of temperature
Sterile Positive control
Negative control Biological risk
Electric shock warning Radiation warning

Hot surface Potential pinch-point warning
Laser beam Shearing hazard
High temperature Hazardous magnetic field
Potential tip-over/crush hazard Acute toxicity
Corrosives Sodium azide
Irritant Recyclable
Environmentally friendly use period.

Separate collection for waste electrical Actual number of years may vary by
and electronic equipment product. This symbol is typically
orange in color.
Fuse Direct current
Alternating current Both direct and alternating current
Three-phase alternating current Earth (ground) terminal
Protective conductor terminal Frame or chassis terminal
Equipotentiality ON (supply)

ON (only for a component of the

OFF (supply)
system equipment)
Equipment protected throughout by

OFF (only for a component of the double insulation or reinforced
system equipment) insulation (Equivalent to Class II of IEC
536)
For US Only: Caution: US Federal Law
Ethernet port restricts this device to sale by or on the
order of a licensed practitioner
Importer

2 Safety Information
It is essential that the warnings, cautions and safety requirements contained in this document
are read and understood by the user before operating the system.
Warning symbols have been placed on the system to draw your attention to areas of potential
hazards.
System Compliance
The BACT/ALERT® VIRTUO® System conforms to the relevant European regulations for
electrical safety and electromagnetic compatibility (EMC).
• This IVD instrument complies with the emissions and immunity requirements of IEC
61326.
• This is a Class A product. This instrument was designed and tested against CISPR 11,
class A. In a domestic envrironment this product may cause radio interference, in which
case the user may be required to take adequate measures.
• bioMérieux recommends the evaluation of the electromagnetic environment before
operating the instrument.
CAUTION: Use of this instrument in a dry environment, especially if synthetic

materials are present (for example synthetic clothing and carpets) may cause
damaging static discharges that may cause erroneous results.
Electrical Warnings
BACT/ALERT® VIRTUO® is designed and tested in accordance with these standards and is
supplied in a safe condition. A CB Certification and Construction file is established for the
apparatus.
• EN 61010-2-101:2002, Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use; Part 2-101: Particular Requirements for In-Vitro Diagnostic
(IVD) Medical Equipment.
• EN 60825-1:2007, Safety of laser products: Part 1: Equipment Classification and
Requirements; and 21 CFR 1040, Performance Standards for Light-Emitting Products.
• EN 55011-2007, Radiated Emissions
• European Parliament Directive 2002/95/EC, 2003, Restriction and Use of Certain
Hazardous Substances in Electrical and Electronic Equipment (RoHS).

Electrical Grounding Safety Information
WARNING
Adhere to the following warnings to ensure safe operation and to maintain
the apparatus in a safe condition:
• When cycling AC power on BACT/ALERT® VIRTUO® components, wait
several seconds between the Off cycle and the On cycle. Rapid cycling of
the power switch may cause the instrument to malfunction.
• Intentional interruption of the protective conductor inside or outside the
apparatus, or disconnection of the protective ground terminal, is
prohibited.
• Disconnect the apparatus from all voltage sources before it is opened for
any adjustment, replacement, maintenance, or repair.
• Do not perform any adjustments, maintenance, or repairs of the opened
apparatus while under voltage. If this is unavoidable, a skilled person who
is aware of the hazard involved must maintain the instrument.
• If the BACT/ALERT® VIRTUO® instrument has been impaired, disconnect
the power cord to render it inoperative and secure it against any
unintended operation. If moisture is evident, turn off the machine at the
breaker before removing the power cord and fuse.
WARNING
A potential hazard of electrical shock exists during service and maintenance,
electrical checks, or manual load mode.
WARNING
Ensure that product labeling is not corrupted during cleaning and handling
procedures. The consequences of not following the proper cleaning
procedures may be loss of marking and lack of electrical safety/ hazard
awareness.
WARNING
Contact your local bioMérieux representative if any of the following
conditions occur:
• System shows visible damage.
• System fails to perform intended measurements.
• System has been subjected to storage under unfavorable conditions (for
example, above 90% humidity, extreme temperatures, dusty environment,
prolonged storage).
• System has been subjected to severe transport stresses.
Electrical Grounding
An electrical ground is required for this instrument. Before installing the instrument, ensure
that a grounded wall receptacle is available for each instrument, which is factory equipped
with a power supply cord that has the appropriate grounding plug. Plug the instrument into the

Electrical and Electronic Recycling Safety Information
UPS and plug the UPS into a mating grounding type wall receptacle in accordance with the
National Electrical Code and applicable local codes and ordinances for this type of
installation.
WARNING
Do not remove the power cord’s ground prong under any circumstances.
Figure 1: Electrical Grounding Requirements
1 US Standard
2 220 Volt - European
Electrical and Electronic Recycling

European countries have set up a directive on waste electrical and electronic equipment. This
Warning statement only applies to European countries regarding the directive.
WARNING
This statement only applies to European countries with regard to the waste
electrical and electronic equipment European directive:
You can play an important role in contributing to reuse, recycling, and other
forms of recovery of waste electrical and electronic equipment. Sorting this
type of waste significantly reduces potential negative effects on the
environment and human health as a result of the presence of hazardous
substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of the product as
unsorted municipal waste, even if it is decontaminated. It is imperative that
you contact bioMérieux to assure its appropriate disposal.
Appropriately dispose of packaging materials.
USB Devices
It is recommended to use only bioMérieux-supplied USB devices with bioMérieux equipment.

Before using USB devices with bioMérieux equipment, scan the devices on a separate
computer using current antivirus software to ensure viruses are not introduced to the
equipment. Do not use USB devices intended for bioMérieux equipment in other computers
that do not have current antivirus software installed and active.

Instrument Labels Safety Information
WARNING
The following potential risks exist if bioMérieux-supplied USB devices are
not used:
• Spreading a virus to bioMérieux equipment
• Loss of function
• Loss of results
Use caution when transferring USB devices between computers.
Instrument Labels
The BACT/ALERT® VIRTUO® instrument has multiple labels on various parts of the
instrument. Labels may be used to provide information or to make the user aware of potential
hazards. It is important to be familiar with the location and meaning of the labels on the
instrument.
The instrument label is located inside the instrument and is visible upon opening the waste
compartment door. The instrument label contains the part number of the instrument (REF),
the name of the instrument, the serial number (S/N), the instrument voltage, and the
instrument product identity.
Note: The XXXXX in the instrument serial number will be replaced by the assigned serial number.
IMPORTANT: Symbols and information listed on the instrument label are accurate; however, the
placement of the symbols and information on the instrument label are subject to
change.

Figure 2: Instrument Label for the A-unit
1 Instrument Date of Manufacture

2 Instrument Name
3 Instrument Reference Number/Part Number
4 Instrument Serial Number
5 Instrument Voltage
6 Instrument Product Identity

Figure 3: Instrument Label for the B-unit
1 Instrument Date of Manufacture

2 Instrument Name
3 Instrument Reference Number/Part Number
4 Instrument Serial Number
5 Instrument Voltage
6 Instrument Product Identity
The instrument contains a Class 1 laser. Laser caution labels appear on the instrument to
inform the user that there is a presence of a Class 1 Laser Product in the instrument. The
expanded Class 1 Laser Product label appears on the rear of the instrument. The simplified
label appears on the door handle.
WARNING
Do not try to access the interior of the laser case for any reason. Failure to
comply may result in exposure to radiation and result in personal injury and
damage to the instrument.

Figure 4: Class 1 Laser Product Label — Expanded
Labels appear on the door handle to inform the user about the presence of a Class 1 laser,
biological risks, and risk of potential pinch points. The user is also cautioned to consult
documentation that accompanies the instrument.
Figure 5: Door Handle Labeling
1 Class 1 Laser Product

2 Biological Risk
3 Potential Pinch Point Warning
4 Caution, Consult Accompanying Documents
WARNING
All biological samples and quality control (QC) products incubated in this
system, as well as all waste in the waste containers, should be treated as
potentially biohazardous materials. All materials and mechanical
components associated with the waste systems should be handled
according to safe microbiological practices in compliance with the
installation site's biohazard procedures. Use the personal protective
equipment recommended by the facility when handling any of these
components, including gloves, safety glasses, and a lab coat.
The system must be decontaminated before its covers are removed by
service personnel. Ensure that appropriate decontamination is carried out if
hazardous materials are spilled on or into the equipment or surrounding
areas.

WARNING
A potential biohazard exists in these situations:
• A bottle is not correctly identified.
• A bottle leaks from damage or another cause.
• Entrapped biohazard substances are not properly cleaned.
• Proper cleaning guidelines are not correctly followed.
• Surfaces are not cleaned properly.
WARNING
A potential pinch hazard exists for the following scenarios:
• Moving parts during servicing or normal operation
• Moving parts during mechanical check
• Mechanical parts during manual loading of bottles
• Mechanical parts during manual unloading of bottles
Negative bottles unload to the waste container. The waste container can be accessed by
opening the waste container door. A label appears on the waste container to remind the user
that biological risks may still be present in negative bottles.
Figure 6: Waste Container Labeling
1 Waste Container
2 Biological Risk
3 Waste Container Door

Figure 7: Electrostatic Discharge (ESD) Labeling
1 Electrostatic Discharge Sensitive

Components
The instrument contains a Heater Fan that emits hot air. A High Temperature caution label
appears on the interior of the instrument on the Heater Fan Assembly to inform the user that
they should use caution when working around the Heater Fan.
Figure 8: Heater Fan Assembly Labeling
1 High Temperature
The Power Supply Cover Plate covers electrical components. An Electric Shock Warning
label appears on the Power Supply Cover Plate to warn the user that the risk of electrical
shock exists if the Power Supply Cover Plate is not present. The user should not remove the
Power Supply Cover Plate or enter the interior of the instrument when the Power Supply
Cover Plate is not present.

WARNING
The power supply is housed beneath the power supply cover in the power
supply bay. Contact with components in the power supply bay can lead to
exposure to electrical current when power is applied to the instrument. When
performing any procedure where the power supply cover is removed, extra
precautions must be taken to ensure the power supply cover is installed
before returning the instrument to customer use. Failure to comply may
result in serious injury or death to the user.
Figure 9: Power Supply Cover Plate Labeling
1 Electric Shock Warning

2 Power Supply Cover Plate
WARNING
A potential hazard of electrical shock exists during service and maintenance,
electrical checks, or manual load mode.
The door latch cover contains a bottle orientation label to assist the user with the correct
positioning of bottles for the instrument

Figure 10: Bottle Orientation Label
1 Bottle Orientation Label
Place the bottles so that the bottle type information can be read. Do not place the bottles with
their caps down and do not place the bottles on their sides.
The Rack Cover Plate is located on the Rack Mount Assembly. A caution label is located on
the far right side of the rack cover plate to alert the user to consult documentation that
accompanies the instrument.
Figure 11: Rack Cover Plate Caution Label
1 Caution Label
WARNING
Do not use compounds that will harm polycarbonate (for example
CIDEXPLUS® 28 Day solution) to clean the rack cover plate. Failure to comply
results in damage to the rack cover plate.

Safety Precautions Safety Information
Safety Precautions
Pay particular attention to the following safety precautions. If these safety precautions are
ignored, injury to the operator or damage to the instrument may occur. Each individual
precaution is important.
WARNING
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
WARNING
All biological samples and quality control (QC) products incubated in this
system, as well as all waste in the waste containers, should be treated as
potentially biohazardous materials. All materials and mechanical
components associated with the waste systems should be handled
according to safe microbiological practices in compliance with the
installation site's biohazard procedures. Use the personal protective
equipment recommended by the facility when handling any of these
components, including gloves, safety glasses, and a lab coat.
The system must be decontaminated before its covers are removed by
service personnel. Ensure that appropriate decontamination is carried out if
hazardous materials are spilled on or into the equipment or surrounding
areas.
WARNING
Treat waste material, including consumable items, and any components
coming into contact with waste material as having the potential hazards of
the samples used.
All service personnel should be familiar with the Material Safety Data Sheet
(MSDS) for all materials used in the procedures relating to this instrument,
and the correct procedures for handling these materials.
WARNING
Even when power is removed from the instrument, the potential exists for
electricity to be generated if components, such as assemblies that are
mounted on belts, are moved too quickly. Components should be moved
slowly to prevent the buildup of electricity. Failure to comply may result in
injury to personnel or damage to the instrument.

WARNING
Do not replace detachable main supply cords by inadequately rated cords.
Only use main supply cords provided by the manufacturer.
Do not replace electric cables. If cables do not have the same technical
specificities, there is a risk of electrical shock.
WARNING
Electronic equipment can be the source of electrical shocks. Installation,
service, and repair should only be performed by authorized and qualified
bioMérieux personnel.
WARNING
All power switches should be off when connecting or disconnecting cables
to power outlets to reduce the risk of electrical shock.
WARNING
bioMérieux recommends connecting this instrument to a main power outlet
that is protected with a ground fault circuit interrupter to reduce the risk of
electrical shock.
WARNING
As with any mechanical system, certain precautions must be taken when
operating the instrument. The instrument has a protective cover intended to
prevent the operator from coming into contact with any moving parts and
aerosols. When servicing the instrument, take special care, as there are
moving parts that can cause injury.
WARNING
Cleaning and disinfecting solutions have corrosive properties. Always wear
protective (chemical resistant) gloves and safety glasses when handling
cleaning and disinfecting solutions.
WARNING
Hot surfaces can cause injury.

CAUTION: Any liquid spilled on the system may result in system

malfunctioning. If liquid is spilled on the system, wipe it up immediately
using decontamination wipes.
CAUTION: The computer and its operating system have been carefully
configured for optimal system performance. Altering the configuration may
severely hamper the usability of the instrument.
Note: Before performing electrical safety or other compliance testing on the instrument, contact
bioMérieux or your local distributor.
WARNING
The user must only perform the maintenance operations described in this
document and rigorously follow each of the steps.
The use of tools not specified by bioMérieux is forbidden.
Powder-free gloves, a lab coat and protective glasses or goggles must be
worn when performing maintenance operations.
Always use personal protective equipment, including gloves, a lab coat and
safety glasses or goggles when handling reagents.
WARNING
Use caution when operating the instrument in a high EFT (Electrical Fast
Transient) environment. Alarms or alerts may occur.

3 System Overview
Introduction to BACT/ALERT® VIRTUO®
BACT/ALERT® VIRTUO® is the next generation of BACT/ALERT® instrumentation and is

comparable to the BACT/ALERT® 3D Microbial Detection System. The system is noninvasive.
The BACT/ALERT® VIRTUO® provides automated loading and unloading of culture bottles,
improved optics, improved thermal stability, redesigned racks, and an improved user
interface.
Once a culture bottle is loaded on the conveyor, handling of the culture bottle is generally not
required until a result is obtained and the bottle automatically unloads.
Automatic bottle scans determine the bottle ID and bottle type from the bioMérieux bottle ID.
The system also reads and assigns user applied barcodes, such as the accession ID, patient
ID, or alternate bottle ID. The system decodes the bioMérieux 2D bottle barcode to determine
the expiration date, the lot number, and information about the authenticity of the bottle. For
bottles with a fill-to line on the label, the system determines the sample volume within the
bottle and alerts if the bottle is underfilled or overfilled. An image of the bottle label is
generated before placing the bottle in the incubator. Sample results will appear on the
instrument’s Large Display. Positive bottle results are audible by a user-configured sound as
well.
The disposable culture bottles contain a liquid emulsion sensor that is monitored continuously
using solid state photo detectors. In addition, the bottles contain media and atmosphere that
promote the recovery of a wide variety of microorganisms.
The system supervises the reading of the culture bottles and contains a decision-making
algorithm to determine which samples are positive or negative.
If no microbial growth is present after a specified maximum test time, the sample is
determined to be negative. By default, negative and positive bottles automatically unload to
the waste container or bottle retrieval area. Bottles can also be unloaded at user request if
configured.
Instrument Configuration
The BACT/ALERT® VIRTUO® instrument is modular and scalable, and can be upgraded to
accommodate increased capacity requirements. Each unit contains 16 racks with 27 cells
each for bottle monitoring. Four cells are dedicated for calibration standards. An instrument
has a total capacity of 432 cells.
System Configuration
A BACT/ALERT® VIRTUO® instrument bank may consist of a single A-unit or an A-unit and up
to three B-units attached with a common loading area and Large Display screen.
BACT/ALERT® VIRTUO®bank configurations include:
• Standalone Configuration
• Multi-Instance Site Configuration
• Primary/Secondary Site Configuration
IMPORTANT: All networked configurations support connection to a Laboratory Information System

(LIS) and to a VILINK® server for remote customer support.

Standalone Configuration System Overview
WARNING
Failure to follow the instructions to configure instruments may lead to
incorrect results.
Standalone Configuration
Standalone configuration allows an instrument or bank to stand alone or be connected to a
user network (LIS, VILINK® remote support, and network printers).
Multi-Instance Site Configuration

Multi-Instance site configuration allows multiple standalone BACT/ALERT® VIRTUO® banks to
be connected to a MYLA® v4.8 or later external data management server or MAESTRIA™
v5.0 or later external data management server.
Figure 12: Multi-Instance Site Configuration Diagram
Note: Users with Multi-Instance site configuration may need to refer to the MYLA® V4 User Manual
(or later) or the MAESTRIA™ V5 User Manual (or later).
IMPORTANT: In Multi-Instance site configuration, BACT/ALERT® VIRTUO® instruments do not

display LIS alarms. Instead, LIS alarms display on the bioMérieux middleware
dashboard.

Limitations of Use System Overview
Limitations of Use
Multi-Instance site configuration has the following limitations of use:
• Up to four BACT/ALERT® VIRTUO® A units can be connected in Multi-Instance site
configuration. Each A unit can be connected to three B units.
• Bottles cannot be reloaded across different BACT/ALERT® VIRTUO® banks in Multi-
Instance site configuration.
• Multi-Instance site configuration is not intended for use by blood banks.
• Multi-Instance site configuration is only for clinical users.
Bottle Management
WARNING
Moving bottles between banks may cause false negative results.
Bottles must not be moved between banks in Multi-Instance site configuration. When a bottle
is reloaded into a different bank, the bottle record does not transfer to that bank and analysis
is interrupted and incomplete. No warning appears on the Bottles in Progress screen when a
bottle is moved between banks.
A bottle must be reloaded into the same bank from which it was unloaded. To identify the
appropriate bank, go to the bioMérieux middleware dashboard, search by disposable ID, and
view the Patient Visit or Bottle Record screen.
Primary/Secondary Site Configuration

Primary/Secondary site configuration allows multiple secondary BACT/ALERT® VIRTUO®
banks to communicate with MYLA® or MAESTRIA™ through a single primary bank.

Limitations of Use System Overview
Figure 13: Primary/Secondary Site Configuration Diagram
Note: Users with Primary/Secondary site configuration may need to refer to the MYLA® V4 User
Manual (or later) or the MAESTRIA™ V5 User Manual (or later).
IMPORTANT: In Primary/Secondary site configuration, BACT/ALERT® VIRTUO® instruments do not

display LIS alarms. Instead, LIS alarms display on the bioMérieux middleware
dashboard.
Limitations of Use
Primary/Secondary site configuration has the following limitations of use:
• Up to sixteen BACT/ALERT® VIRTUO® instruments (A units and B units) can be
connected in Primary/Secondary site configuration. Each A unit can be connected to three
B units.

Bottle Management System Overview
• It is strongly recommended to perform an internal validation prior to transferring negative-

to-date bottles between banks, as described in Bottle Management.
Bottle Management
Bottles can be moved between banks in Primary/Secondary site configuration. When a bottle
is reloaded into a different bank, the bottle record transfers to that bank and analysis
continues. For example, when a bottle is unloaded from Bank 1 and reloaded into Bank 2, the
bottle record transfers to Bank 2. You can no longer view the bottle in Bank 1 and must view it
in Bank 2 instead. The bottle information on the bioMérieux middleware dashboard only
includes the bottle's current location.
You can access the audit trail in the bioMérieux middleware for the complete history of the
bottle record.
Communication Loss
In a Primary/Secondary site configuration, secondary A-units communicate with the primary
A-unit to receive information. When communication is lost, secondary A-units display the alert
in the figure below. This alert indicates that information displayed on the secondary A-units is
either unavailable or outdated.
Figure 14: Loss of Communication on Secondary A-unit
Identifying Primary and Secondary Banks
You can identify whether an instrument bank is primary or secondary on the System
Information screen of the bank's A unit.
On the A unit's Home screen, select Application and Instrument Information.
The System Information screen appears. On the System Information screen, A(P) or A
may appear in the Type column for the A unit.
• A(P) indicates that the A unit is in a primary bank.
• A indicates that the A unit is in a secondary bank.
Figure 15: System Information Screen on Primary and Secondary A-units

Data Management System Overview
1 A-unit in primary bank
2 A-unit in secondary bank
3 Secure HTTPS connection
Data Management
bioMérieux data management is a separate software system that manages the data
generated by BACT/ALERT® VIRTUO®. Both predefined and user-customized queries and
reports are available. This data management software provides a high level of flexibility to
store data for a definable length of time, edit, query, sort, and produce reports.
Reagents
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
Bottles Supported for Use

Use the BACT/ALERT® blood culture bottles listed with BACT/ALERT® VIRTUO®.
Note: Refer to the BACT/ALERT® bottle Instructions for Use before using the bottles.
• Clinical Bottles
◦ BACT/ALERT® SA
◦ BACT/ALERT® SN
◦ BACT/ALERT® FA PLUS
◦ BACT/ALERT® FN PLUS
◦ BACT/ALERT® PF PLUS
• Industry Blood Bank Bottles
◦ BACT/ALERT® BPA
◦ BACT/ALERT® BPN
◦ BACT/ALERT® BPA EU
◦ BACT/ALERT® BPN EU
◦ BACT/ALERT® BPA US
◦ BACT/ALERT® BPN US
Note: The clinical bottles listed above support fill volume except BACT/ALERT® PF PLUS.
BACT/ALERT® PF PLUS does not support fill volume because it is a low specimen volume
clinical bottle. See the Instructions for Use.
WARNING
A potential hazard (false negative test results) exists if non-bioMérieux
and/or unsupported and/or substandard bottles are used with the instrument.
Use only bottles manufactured by bioMérieux.

Bottles Not Supported for Use System Overview
WARNING
A biohazard risk may occur if glass culture bottles are loaded in the
instrument. Never load glass bottles in the instrument.
WARNING
Use only plastic bottles with the instrument. A potential hazard (false
negative test results) exists if plastic bottles are not used with the
instrument.
Note: Do not load bottles with third party adapters on top.
Bottles Not Supported for Use

Do not use the following bottles with BACT/ALERT® VIRTUO®. These bottles are not
supported for use with BACT/ALERT® VIRTUO®.
• Industry Bottles
◦ BACT/ALERT® iLYM
◦ BACT/ALERT® iAST
◦ BACT/ALERT® iNST
◦ BACT/ALERT® iFA
◦ BACT/ALERT® iPF
◦ BACT/ALERT® iFN
◦ BACT/ALERT® iFN PLUS
◦ BACT/ALERT® iFA PLUS
• FAN Bottles
◦ BACT/ALERT® FA
◦ BACT/ALERT® FN
◦ BACT/ALERT® PF
• Mycobacterium Bottles
◦ BACT/ALERT® MP
Additional Supplies
The following are additional supplies to be used with the instrument:

• Wireless External Keyboard
• USB Printer
• Network Printer
• VIRTUO® Warning Light Tower
• UPS
Contact bioMérieux or your local vendor for laboratory supplies and accessories.

System Temperature Guidance System Overview
System Temperature Guidance
BACT/ALERT® VIRTUO® has an incubation temperature port at the top of the instrument. To
perform independent temperature monitoring, use a probe up to 8 mm wide and install in the
probe holder located at the top of the instrument. The probe reading should match the
temperature on the instrument screen within +/- 2 °C.
The BACT/ALERT® VIRTUO® also supports temperature mapping by an independent
mapping tool. Contact your local bioMérieux representative for assistance.
WARNING
Do not step on an unstable device or platform to place an independent
temperature probe in its correct external location to perform an independent
instrument calibration check as the consequence may be a physical injury or
crush hazard.
WARNING
The consequences of the failure to use an independent temperature
monitoring probe that meets specifications may be false negative results.
WARNING
A bioMérieux representative must perform independent temperature
checking. The consequences of changing the offset may be false negative
results.
WARNING
The consequences of using (and leaving) an independent temperature
mapping probe inside the instrument may be delayed results.
Theory of Operation
Principle of Detection
According to the Principle of Detection, if microorganisms are present in the test sample,
carbon dioxide (CO2) is produced as the microorganisms metabolize the substrates in the
culture medium. When growth of the microorganisms produces CO2, the color of the sensor in
the bottom of each culture bottle changes from dark to light.
A light-emitting diode (LED) projects light onto the sensor. A photodetector measures the light
reflected. As more CO2 is generated, more light is reflected. This information is compared to
the initial sensor reading. A high rate of CO2 production and/or a sustained production of CO2
indicate the sample is positive.
If the CO2 level does not change significantly after a specified number of days at optimal
conditions, the sample is negative.

BACT/ALERT® VIRTUO® Hardware System Overview
WARNING
A potential hazard of false negative test results exists if:
• The system is used for release testing based on preliminary or user-
modified results.
• The system is used off label.
• The operator fails to follow intended use guidelines.
CAUTION: Unloading or manipulating the bottles when not indicated by the

system may interfere with critical bottle readings.
BACT/ALERT® VIRTUO® Hardware
Each instrument contains 16 racks with 27 bottle cells each, for a total of 432 cells.
WARNING
A potential of user injury exists if accessories are used that have sharp
edges or are otherwise not UL compliant.

Figure 16: A Unit Front View

1 Warning Light Tower (Optional) Indicates a visual status for the instrument from any angle in
the lab.
2 Large Display Displays bottle and system information. Includes a touchscreen

so that the operator may enter information by touching the
screen. This Large Display is used for the majority of the
functions.
3 USB Port Available for system backup, system restore, an optional

keyboard, and other USB devices.
4 Barcode Scanner Scans data from a barcode into the software, and displays
information for a bottle.
5 Loading Area Automatically loads from one to 40 bottles into the instrument
at a time.
6 Waste Container Holds all negative bottles that are unloaded. Periodically empty
the waste container based on instructions on the Large
Display.
7 RJ45 Connectors (2) Connects the PC and the MCB with an external router or
switch.
8 USB Connector Connects to a UPS.
9 Power Switch Turns the AC Power to the instrument On and Off.
10 Power Cord Connector Connects to AC power cord.
11 Bottle Indexer and Transfer Arm with Transfers the bottles to the inside of the instrument where the
Cover bottle label is scanned and the bottle is positioned for loading
or, if configured, transfers to the next connected instrument.
12 Bottle Return Chutes (2) and Bottle Unloads positive bottles to the Bottle Retrieval Area, and also
Retrieval Area unloads selected bottles at user request.
13 Small Display Displays instrument temperature. Includes a touchscreen so

that the user may select information by touching the display.
This display is mainly used for individual instrument status and
maintenance.
14 Audible Alarm Speaker Flags instrument failures, operator errors, and positive bottle
results.
15 System Status Indicator (SSI) Indicates a visual status for the instrument. Illuminates in
yellow, green, or red depending on the level of alarm or alert
(for example, yellow or red can indicate a positive bottle).
16 Temperature Probe Opening Opening for incubation temperature port to perform

independent temperature monitoring.

Figure 17: A Unit Front View - Front Door Open
1 Heater/Fan (4) Controls the temperature inside the incubator.
2 Rack Detection Assembly (RDA) Holds four racks and controls agitation (rocking).
3 Kick Stand Supports the cabinet door when it is opened.
4 Wheels (4) and Stabilizing Feet (2) Wheels move the instrument. Stabilizing feet adjust to prevent
movement.
5 Robot Arm Automatically loads bottles to an available cell and unloads

bottles to either the waste container or the bottle return chutes
(depending on bottle status and how the instrument is
configured).
6 Rack Contains 27 cells. The racks are designated with a letter from A
to P.
7 Cell Each cell is designated with a number from 1 to 27. Each cell
holds and monitors one culture bottle.

Figure 18: A Unit Rear View
1 Handles (2) Moves the instrument.
Figure 19: Indexer and Transfer Arm

1 Indexer
2 Transfer Arm
Figure 20: Light Curtain Sensors
1 Light Curtain Sensors

Figure 21: Transfer Gate
Figure 22: Transfer Arm and Gate

B Unit System Overview
Figure 23: Safe to Move Sensor
1 Safe To Move Sensor
2 Safe To Move LED
3 Gripper Assembly
Note: The Safe to Move sensor turns green when it is in the parked position.
B Unit
Each A unit can be connected to up to 3 B units to extend the capacity of a bank. B units have
the same specifications, only without a PC and large display screen.

Figure 24: B Unit Front View
1 Loading Area Accepts bottles from instrument on the left.
2 Waste Container Holds all negative bottles that are unloaded. Periodically empty
the waste container based on instructions on the Large
Display.
3 RJ45 Connectors (2) Connects the PC and the MCB with an external router or
switch.
USB Connector Connects to a UPS.
4 Power Switch Turns the AC Power to the instrument On and Off.
Power Cord Connector Connects to AC power cord.

5 Bottle Indexer and Transfer Arm with Transfers the bottles to the inside of the instrument where the
Cover bottle label is scanned and the bottle is positioned for loading
or, if configured, transfers to the next connected instrument.
6 Bottle Return Chutes (2) and Bottle Unloads positive bottles to the Bottle Retrieval Area, and also
Retrieval Area unloads selected bottles at user request.
7 Small Display Displays instrument temperature. Includes a touchscreen so

that the user may select information by touching the display.
This display is mainly used for individual instrument status and
maintenance.
8 Audible Alarm Speaker Flags instrument failures, operator errors, and positive bottle
results.
9 System Status Indicator (SSI) Indicates a visual status for the instrument. Illuminates in
yellow, green, or red depending on the level of alarm or alert
(for example, yellow or red can indicate a positive bottle).
10 Temperature Probe Opening Opening for incubation temperature port to perform

independent temperature monitoring.
Figure 25: B Unit Rear View
1 Handles (2) Moves the instrument.
Note: If an A unit indexer is unable to load bottles, the cover can be removed from the B unit for
bottle loading.

General Instrument Specifications System Overview
Figure 26: Multi-Instrument Bank
1 A Unit
2 B Units
General Instrument Specifications
WARNING
A potential hazard (false negative test results) exists if the instrument is
operated in an environment that is out of specification, or if proper electrical
power is not maintained.
WARNING
A potential for property damage exists if the instrument is not stored in the
recommended environmental conditions.
Physical Characteristics
Electrical Power 100/120 VAC, 12A (50/60 Hz)
Services Requirements
220/240 VAC, 6A (50/60 Hz)

Physical Characteristics System Overview
Power Consumed in A Unit: @120 VAC (1440 Watts typical); B Unit: @120 VAC
Watts (1320Watts typical)
A Unit: @220 Volts (1320 Watts typical); B Unit: @220 Volts
(1200 Watts typical)
Heat Dissipated A Unit: 1287 BTU/h at instrument set point of 37 °C and ambient
temperature of 20 °C; B Unit: 1129 BTU/h at instrument set
point of 37 °C and ambient temperature of 20 °C
Sound Emission 60 dBA (normal operation)
67 dBA (loading bottles)
Dimensions (Instrument Height: 196 cm (77.2 in.)*
Door Closed)
Width: 73 cm (28.7 in.)
Depth: 91 cm (35.8 in.)
Dimensions (Instrument Height: 196 cm (77.2 in.)*
Door Open)
Width: 94 cm (37 in.)
Depth: 165 cm (65 in.)
Mass (Empty) A Unit: 292 kg (643 lb); B Unit: 284 kg (625 lb)
Mass (Loaded with A Unit:321 kg (707 lb); B Unit: 313 kg (689 lb)
Bottles)
Clearance • Instrument can be placed with its back against the wall.
• Minimum unobstructed clearance of 25 cm (10 in.) must be
provided on the left side of the left most instrument.
• Minimum of 30 cm (12 in.) clearance above the instrument
Maximum Installation 2000 m (6562 ft) above sea level

Altitude
Handling Two people, using the handles on the rear of the instrument.
* Height dimension does not include optional Signal Tower (Warning Light Tower).
CAUTION: The BACT/ALERT® VIRTUO® instrument is heavy. Only use

approved lifting techniques to move the instrument. Failure to comply may
result in severe damage to the instrument and/or personal injury from a
crush hazard.

Environmental Characteristics System Overview
Environmental Characteristics
Installation Location Indoor usage only. Do not install under or near a HVAC register
or in direct sunlight or bright overhead lights. Install on a level
surface.
Ambient Room 15 °C to 28 °C (59 °F to 82 °F), ambient temperature must be at
Temperature least 9 °C below the incubator set point as measured 10-15 cm
(4-6 in) above the instrument door.
Shipping/Storage −17 °C to 57 °C (0 °F to 135 °F)
Temperature
Operating Humidity 20% to 80% relative humidity, non-condensing
Shipping/Storage 20% to 85% relative humidity, non-condensing
Humidity
Maximum Operating and ≤ 2000 meters (6562 feet)
Storage Altitude
Pollution Degree Degree 2 in accordance with IEC 664
Overvoltage Category II per IEC 664
Laser Class 1 laser product. Complies with 21 CFR 1040.10 and
1040.11 except for deviations pursuant to Laser Notice No. 50,
dated June 24, 2007.
BACT/ALERT® VIRTUO® Screens
Note: Some text in the software's user interface is not translated and appears in English.
Large Display
The table names and describes the screens that are available on the Large Display.
Table 1: Large Display Elements
Screen Screen Name Description

Icon
Home Return to the Home screen from any other screen.
The Home screen displays the instrument status,
including the number of cells available, number of
positive and negative bottles, alarms, and alerts. The
buttons that navigate to other function screens are on
the Home screen.
Search Search for bottle test data based on user-

configurable criteria.
Display Bank Display detailed information for each instrument in a
bank.
A bank is a group of instruments that are physically
connected.
Reports Access standard instrument reports and bottle

reports.

Small Display System Overview
Screen Screen Name Description

Icon
Configuration Configure instrument to meet specific lab
requirements (for example, user login required to
perform certain actions, maximum test time, waste
container capacity threshold, positive and negative
bottle automatic unloading).
Note: The BACT/ALERT® VIRTUO® PC performs a reboot the first day of each month at 1:00 AM.
During the reboot, the Large Display is unavailable. The reboot does not interrupt bottle
processing.
Note: If you experience slow PC performance, reboot the PC. See Rebooting the Internal PC
(Large Display). If the slowness persists after reboot, contact your local bioMérieux
representative for assistance.
Small Display
The Small Display is located above the bottle return chutes. Use this display to access
specific instrument status information and maintenance functions.
Figure 27: Small Display
The Small Display screen presents system information and icons as listed below.
Table 2: Small Display
Icon Name Description

Bottle Status Bottles on the screen are color coded. Positive
bottles are yellow or red (depending on user
configuration), negative to date bottles are blue, and
negative bottles are gray.
IMPORTANT: If the system loses power or
reboots, bottles in the retrieval area default to
negative to date (blue). You must access the
bottle records to confirm result status.

Small Display System Overview

Service For bioMérieux use only.
Manual Unload Positive Manually unload positive bottles during an

automation failure. See Emergency Manual
Unloading Positive Bottles.
Manual Unload Manually unload anonymous bottles during an

Anonymous automation failure. See Anonymous Bottle Alert after
Manual Loading.
Manual Load Bottle Displays when the configured number of barcodes is

scanned and recognized by the barcode scanner.
Manually load the bottle(s) associated with the
barcodes displayed on-screen above this icon. See
Emergency Manual Loading Bottles.
Manual Load Access the Manual Load screen. See Emergency
Manual Loading Bottles.
Open Door Request Sends a request for the robot to finish its activity so
that the door can be safely opened.
Do Not Open Door Displays when opening the door is prohibited.
Door OK to Open Displays when robot has finished activity and door is
OK to open.
Information The Information screen displays the instrument serial

number, instrument name, firmware version, and
knowledge base version. This icon also allows you to
access the other small screen options and
Emergency/Manual Unload option.
Configuration The Configuration screen includes the configuration
elements for the instrument. Can only be accessed
by Field Service Engineers for maintenance.
Robot Activity Indicator Indicates robot is in motion.
Waste Status Display the approximate fill level of the waste

container in 25% increments. For example, the icon
shows that the waste container is 25% full.

Common Screen Elements System Overview

Waste Container Full The waste container is full.
Waste Container The waste container is missing from the waste

Missing container compartment.
Instrument Firmware Used to reboot the instrument.

Reboot
Unavailable Displays if function was not available. If you see this

icon, call bioMérieux.
Ready to Load Indicates the instrument is ready to load bottles.

Does not display if the instrument is initializing or
cannot load bottles using the conveyor for any other
reason.
Figure 28: Bottle Return Chutes
1 Left Unload Chute
2 Right Unload Chute
Common Screen Elements

Common software screen elements include icons, buttons, and text entry fields.

Icons System Overview
Icons
Icons are graphic symbols with text to convey information and concepts.
Buttons
Buttons are rectangular shapes. Select a button to make a choice or activate a function.
The icon on the button face indicates the function of a button.
A gray button is inactive, or disabled, and its associated function is not available.
Figure 29: Button Examples
1 Enabled button
2 Disabled button
Common System Buttons
Table 3: Common System Buttons

Add Search Criteria Display text fields to enter search criteria, or
display selectable search criteria.
Image Display scanned image of bottle.
Cancel Cancel function and return to previous screen.
Checkbox Selected Signify selected option.
Checkbox Not Selected Signify option not selected.
Clear Clear search criteria.
Close Close the window without saving the search

criteria on the Add Search Criteria screen.
Close the Bottle Status Information screen.

Text Entry Field System Overview

Edit Display the edit bottle record for editing the
following bottle data: bottle ID, bottle type,
accession ID, maximum test time in days, bottle
result, expiration date, lot number, and patient
information, depending on configuration settings.
Print Print bottle information.
Save Save bottle information.
Search Search for bottle information based on search

criteria entered or selected.
Unload Unload bottles from the Bottle Status

Information screen, the Edit Bottle Record
screen, or from the Search screen after
performing a search for specific bottles.
View Display the bottle status information for bottles

selected (for example, time to detection, bottle
result, bottle location, load date/time, instrument
name, bottle ID).
Calendar Display the calendar to select start date and time

and end date and time.
Text Entry Field

A text entry field is a rectangular box. Enter text manually with the on-screen keyboard, or
scan a barcode. A figure appears next to a text entry field when text has been manually
entered. The Accession ID field on the Edit Bottle Record screen is an example of a text
entry field.
IMPORTANT: The external barcode scanner used to scan data from a barcode into the software and
display information for a bottle does not beep or provide any sound notification that
the barcode label has been scanned. Monitor the display to ensure that the barcode
has been scanned and is not scanned more than once.
To enter text with the on-screen keyboard, select the field. A cursor appears in the field, and
the on-screen keyboard appears at the bottom of the screen.

Page Scroll Buttons System Overview
Figure 30: On-Screen Keyboard
CAUTION: Failure to locate the on-screen or optional physical keyboard in a

timely manner may lead to delayed results.
Page Scroll Buttons

The Page Scroll buttons are two small buttons with an area between them to display the
current page and the total number of pages. The buttons move the display area to the
previous page or to the next page.
Figure 31: Page Scroll Buttons
1 Previous page scroll button

2 Next page scroll button
Edit Mode
To edit information on a screen, select Edit.
Common Edit and Configure Screen Elements

The example shows the common screen elements that are used for editing bottle settings and
configuring bank settings.

Search Criteria Screen Icons System Overview
Figure 32: Example - Configuring Bottle Settings
1 Bottle type field

2 Drop-down list
3 Display menu button
4 Scroll bar
Search Criteria Screen Icons
Table 4: Search Criteria Screen Icons

Search Search for bottle information based on search
criteria entered or selected.
Delete Cancel the bottle test for the selected bottles.
Unload Unload the selected bottles.
View View a bottle.
Print Print search results.

Search Criteria Screen Icons System Overview

Upload Upload bottle information to the bioMérieux
middleware or to the LIS (based on system
configuration).
Close Close the current screen and return to previous

screen.
Group MTT Edit Edit the max test time for multiple bottles at one
time.

4 System Installation and Setup
CAUTION: Initial installation and setup of BACT/ALERT® VIRTUO® is to be

performed only by a bioMérieux Service Representative.
CAUTION: Once the instrument is moved to its final location, the wheels
should always be turned parallel to the front of the instrument to avoid a
tipover/crush hazard.
At a minimum, place the instrument in a contained environment with controlled access. The
locations should have surfaces that can be easily decontaminated using an appropriate topical
disinfectant. Do not place the instrument in an open corridor or hallway that is accessible to
the general public.
WARNING
A potential tipover/crush hazard exists in the following situations:
• During transit (if the instrument is not secured properly)
• During installation (if the instrument is not secured properly)
• If the instrument is placed on an inadequately designed support surface
(for example, not level)
• From the robotic arm (when the cabinet door is opened)
• During (general) service and maintenance
WARNING
A potential pinch hazard exists for the following scenarios:
• Moving parts during servicing or normal operation
• Moving parts during mechanical check
• Mechanical parts during manual loading of bottles
• Mechanical parts during manual unloading of bottles
If it is necessary to move or store BACT/ALERT® VIRTUO®, contact your local bioMérieux

representative for assistance.
Setting the Date and Time
Note: Only a user with bioMérieux administrator access for the Internal PC can change the date
and time.

Windows Environment System Installation and Setup
Windows Environment
Contact bioMérieux Customer Service to change the system language.
WARNING
If you install your own anti-virus software, follow your own laboratory
information systems policy. The consequences of not following the correct
procedure may be delayed results.
WARNING
Changes to the Windows® environment must be validated before proceeding
and may include consequences of delayed results.
Installing Windows® Security Updates

If the instrument is connected to a network, the following message appears on the Large
Display when Windows® security updates are available for installation. Follow these steps to
install Windows® security updates on the internal PC.
Figure 33: Updates Are Available Message
1. On the Large Display, select View Updates.

The Windows® Update window appears, listing the updates that are available. If
necessary, you can close the window to continue with your work. However, if you close
the window, none of the updates will be installed on the internal PC.

Installing Windows® Security Updates System Installation and Setup
Figure 34: Windows® Update Window
1 Close button
2 Install Now button
2. Select Install Now.

3. Log into the LabAdmin user account to install the Windows® security updates.
Figure 35: LabAdmin Login Window
IMPORTANT: It is the user's responsibility to install Windows® security updates on the

instrument.

5 Basic Functions
Introduction
The basic functions are performed during your daily workflow by using the Large Display.
These functions include:
• Monitoring the system (viewing alarms and alerts, bottle capacity, temperature)
• Managing bottle information
• Configuring the system
• Loading and unloading bottles
• Resolving anonymous bottles
• Searching for specific bottle information
• Viewing, editing, and printing bottle information
Monitoring the System
Monitor the system from the Home screen.
Home Screen
The Home screen displays the system status for all instruments connected within the bank,
including the number of cells available, number of positive and negative bottles, and active
alarms or alerts. The Home screen also displays the buttons that navigate to other function
screens, and a button to silence alarms and alerts for a defined period of time. The Home
screen is divided into five zones, and can be configured.
Figure 36: Home Screen
1 Zone 1
2 Zone 2
3 Zone 3
4 Zone 4
5 Zone 5

Zone 1 Basic Functions
Zone 1
Zone 1 is at the top of the screen and includes the bioMérieux corporate logo and navigation
buttons.
Table 5: Zone 1 - Buttons

Audit Trail Access the audit log for details such as user login
information, bottle test data modification, alarms, and
alerts.
User Management Access bioMérieux User Management to manage

user accounts.
Application and Provide the software version, instrument name, serial

Instrument Information number, and firmware version for each instrument.
Help Access the BACT/ALERT® VIRTUO® User Manual for

detailed procedures for operating the instrument.
Logout Log out user.
Zone 2
Zone 2 is located just under Zone 1 on the Home screen. Zone 2 displays all active alarms
and alerts that have not been resolved. Zone 2 also indicates when bottles are loading and
unloading.
Alarms and alerts are divided into five categories. A specific icon represents each category of
alarm or alert.
To view an alarm or an alert, select the icon.
Note: The number of occurrences of each type of alarm and alert appears below the icon.
The table describes the five categories of alarms and alerts.
Table 6: Zone 2 - Alarm and Alert Types

Anonymous Bottle A bottle is loaded and the bottle ID or bottle type
could not be determined. A bottle imager
malfunction, or a damaged, smudged, or
obstructed label may prevent barcodes from being
scanned.
Bottle An error that relates to a bottle (for example,

missing bottle data, data integrity error, expired
bottle alarm).


Instrument An error that relates to the instrument’s ability to
process bottles (for example, system capacity,
waste container capacity, incubation
temperature).
Communication An error that relates to communication problems

between the instrument and PC (for example,
unable to send or receive messages from the
instrument).
PC An error that relates to problems with the internal

PC located inside the instrument.
IMPORTANT: Alarms and alerts remain on the screen until they are resolved.
In addition, severity symbols may appear with the alarm or alert icon.
Table 7: Zone 2 - Alarm and Alert Severity Symbols
Symbol Name Description

Alarm An alarm indicates a problem that must be resolved
immediately for the system to operate properly (for
example, robot jam, indexer jam, temperature
issues).
Alert An alert does not prevent the system from operating
properly (for example, anonymous bottle). You must
be aware of the alert.
The Snooze button quiets an alarm or alert to allow extra time for resolution. The Snooze
button is in Zone 2 and appears on every screen.
Note: The Snooze button cannot be used to quiet an alarm or alert while the instrument is
experiencing a communication loss.
The length of time the snooze feature is enabled is configurable. See Configuring Snooze
Time Period.
Figure 37: Snooze Button

Zone 3
Zone 3 is in the center of the Home screen. Zone 3 displays the number of cells available and
the total number of positive and negative bottles currently loaded.
Table 8: Zone 3 - Bottle Status Information

Available Cells Displays the total number of available cells
in the bank. The number of available cells
continuously updates as bottles are loaded
and unloaded.
Negative Bottles Displays the total number of bottles in a
bank (identified and anonymous) that have
completed testing with a negative test status
and have not been unloaded. This bottle
count continuously updates as bottles
complete testing and are determined
negative. Unload appears at the bottom of
the icon if the instrument is configured to
unload all negative bottles by user request.
Positive Bottles Displays the total number of bottles in a
bank (identified and anonymous) that have
completed testing with a positive test status
and have not been unloaded or removed
from the bottle retrieval area. This bottle
count continuously updates as bottles
complete testing and are determined
positive. Unload appears at the bottom of
the icon if the instrument is configured to
unload all positive bottles by User Request.
Note: Yellow or red indicates a positive test
status.
WARNING
Remove positive bottles in a
timely manner. The
consequences of delays may
be delayed results.
Non-communication Indicates displayed data may not be current

Example because communication with the instrument
is lost or is in the process of synchronizing
data.
IMPORTANT: The number of negative and positive bottles appears on every screen.
Zone 4
Zone 4 is located at the bottom of the Home screen. Zone 4 displays the user name, the bank
name, the lab name, and the software release version.

Zone 5
Use the navigation buttons on the left side of the Home screen to access additional function
screens. See Large Display.
Display Bank Screen

To access detailed information for each instrument within a bank, select Display Bank on the
left side of the Home screen.
The Display Bank screen includes an Instrument Status icon for each instrument. Each icon
contains the following information:
• Instrument Name
• Incubator Temperature (ºC)
• Number of Positive Bottles
• Number of Negative Bottles
• Number of Available Cells
• Number of Out-of-Service Cells
• Waste Container Capacity Level (black bars indicate occupied space and white bars
indicate available space)
• Active Alarms and Alerts
• PC and Instrument Status
Figure 38: Display Bank Screen
1 Instrument status icon (Icon displays for each instrument

in the bank)
2 Number of negative and positive bottles in system

(Includes all instruments that are part of the bank)
System Log In
A user account is required to log in to the system. Establish user accounts through the
bioMérieux User Management System. Select User Management in Zone 1 to access the
User Management Application. See System Configuration for more information.

Logging in to BACT/ALERT® VIRTUO® Basic Functions
WARNING
A potential hazard (incorrect result) exists if passwords are not strong
enough to prevent an unauthorized user from gaining access to the system.
See Password Policy.
Logging in to the instrument may be required to perform the following functions:

• Access any function (except loading bottles)
• Unload positive or negative bottles
• Acknowledge an alarm or alert
• Change instrument configuration
• Edit bottle data
• Update system
• Review audit trail
Logging in to BACT/ALERT® VIRTUO®
If a function requires a log in, the User Login window appears.

1. Enter your user name and password.
2. Select OK.
The user name appears in the lower left corner of the screen.
Inactivity Timeout
If no operator activity has been recorded within a user-configured period of time, the
instrument automatically logs you off. To perform functions that require a user login, enter a
user name and password again.
Applying a Barcode Label to a Bottle
Settings on the General Software Configuration screen determine the number of barcode
labels on the bottle and may include an alternate bottle ID, an accession barcode, or a patient
barcode, for a maximum of two user applied barcodes.
The BACT/ALERT® VIRTUO® supports the following user applied 1D barcode symbologies:
• Code 128
• Code 39
• Codabar
• Interleaved 2of5 with check-digit
• UPC
• Code 93
The following specifications are required for user applied 1D barcodes listed above:
• Grade B or better
• Minimum Element Size: 6.7 mil (0.17 mm)
• Minimum Barcode Height: 0.25 in (6.35 mm)
• Minimum Digits (Interleaved 2of5 ONLY): 6

Applying a Barcode Label to a Bottle Basic Functions
• Color: Black barcode font printed on white background

The BACT/ALERT® VIRTUO® system supports the following user applied 2D barcode
symbologies:
• Aztec
• QR
• PDF417
The following specifications are required for user applied 2D barcodes listed above:
• Grade B or better
• Minimum Barcode Size: 0.25 in
• Maximum Barcode Size: 0.5 in
• Color: Black barcode font printed on white background.
Note: Since the PDF417 barcode is rectangular, the size dimensions refer to the smaller of the
two barcode dimensions.
WARNING
The system’s internal barcode scanner requires a check-digit for Interleaved
2of5 (I2of5) by default. bioMérieux has identified a greater risk in using
barcodes without a form of checksum, and strongly encourages using
barcodes with checksums before enabling I2of5 without a check-digit. Inform
the bioMérieux Field Service Engineer upon installation to enable I2of5
without check-digit ONLY if required. Allowing this symbology without
check-digit without need puts other barcodes at risk of incorrect
interpretation and may result in a delay of patient results.
Properly place the barcode label on the blood culture bottles so the instrument can scan the
label accurately.
WARNING
If the proper barcode format is not used, the consequences may be false
negative results.
WARNING
The potential for incorrect results exists if a barcode is not properly applied
to a bottle.
WARNING
If barcode information is not applied to the correct bottle, or if proper
barcode format is not used, the consequences may be false negative results.
If labels are not positioned correctly on the blood culture bottles, the barcode scanner may not
be able to read the barcode. Accession barcodes not scanned trigger the Missing Accession
ID alert. Manually enter the missing accession ID after the bottle is loaded.

Figure 39: Correct Label Placement on the Bottle Label
1 Correct placement and orientation of user applied

barcode label (vertical)
2 Bottle ID barcode
3 Unique Device Identifier (UDI) code
4 2D (Aztec) code
5 Fill-to mark
6 Bottle lot number and expiration date
7 IFU reference number
WARNING
To ensure that bottle and accession barcodes are properly scanned by the
BACT/ALERT® VIRTUO® and that other important bottle information is not
obscured:
• Do not place barcode labels horizontally or at an angle. Instead, place
barcode labels vertically on the bottle.
• Do not cover the entire bottle ID barcode.
• Do not cover the bottle lot number and expiration date.
• Do not heavily overlabel the bottle.
• Do not cover the 2D barcode.
• Do not cover the sample fill indicator.
• Do not cover the open area between the edges of the label.
• Do not cover the bottle sensor on the bottom of the bottle.
• Do not write on the bottom of the bottle.
• Ensure that the exterior of the bottles are clean and do not contain any
sticky substances or residues.
• Do not damage or obscure bottle labels.

WARNING
Failure to maintain cleanliness of bottles, or to avoid sticky substances or
residue on external surface of bottles, or to avoid exposed adhesive from
backing of applied labels, may lead to no results.
WARNING
If the bottle sensor at the bottom of the bottle is obscured during a manual or
auto load, the consequences may be false negative results.
WARNING
Damaged or obscured bottle labels may cause delayed results.
WARNING
Heavily overlabeled bottles may delay results. Heavy labeling impedes
loading the bottle into the cell and unloading the bottle from the cell. A rack
assembly retains bottles in a cell when the bottle diameter is between 34.34
and 35.56 mm.
IMPORTANT: If you write an accession code on the bottle label:

• Allow the ink to dry before loading the bottle in the instrument to prevent smeared
text during processing.
• Although blue inks are still legible, they are less pronounced than the other colors.
Blue inks may appear lighter in the full image than green, red, and black inks.

Loading Bottles Automatically Basic Functions
Loading Bottles Automatically
WARNING
If large numbers of bottles are loaded into BACT/ALERT® VIRTUO®, there
may be a very large heat transfer within the racks. This may trigger the
detection algorithm to erroneously flag positive. To avoid triggering these
conditions, follow these recommendations:
1. Avoid loading over 70 bottles within one hour.
2. Limit the number of bottles loaded in a single batch to no more than 40
bottles.
3. Allow the batch to completely load before adding more bottles to the
conveyor.
Batches of 20 bottles is optimal. If the bank contains multiple instruments,
the probability of false positives due to heat transfer is reduced.
This warning applies to bottles loaded on a single A unit. If a bank contains 1
or more B units, the risk of false positives due to bulk loading is reduced
since bottles are loaded across all units.
The instrument automatically loads up to 40 bottles placed in the loading area at one time. Do
not overload the conveyor.
CAUTION: Do not lean on the conveyor belt at any time.
CAUTION: When the bottle loading area is filled completely , the indexer
cannot reverse bottles (in special circumstances such as instrument full, for
example) to properly re-initialize. An indexer jam alarm results.
WARNING
A biohazard risk may occur if glass culture bottles are loaded in the
instrument. Never load glass bottles in the instrument.
WARNING
Always wear protective gloves when loading bottles into the instrument to
prevent transmitting infectious agents from a bottle leak.

WARNING
Bottles must be at room temperature before use. An erroneous test result
(such as false positive or false negative) may occur if bottles are not at room
temperature when loaded.
CAUTION: Only bottles provided by bioMérieux are authorized for use with
BACT/ALERT® VIRTUO®. bioMérieux shall not be liable as to any defect
(including, but not limited to, incorrect results that may affect patient
outcomes) arising from the use of unauthorized bottles. Users who use
bottles not authorized by bioMérieux do so at their own risk.
WARNING
Do not remove the indexer cover from any instrument when bottles are
loading or transferring between instruments. Removing an indexer cover
may cause instrument jams.
To automatically load bottles into the instrument:

1. Inspect each bottle and sensor before loading.
a) If microbial growth is evident, treat the bottle as positive and do not load into the
instrument for monitoring.
b) If the bottle is cracked, do not load the bottle.
WARNING
A potential hazard (false negative result) exists if the bottle sensor at
the bottom of the bottle is obscured during loading.
WARNING
A potential hazard (false negative result) exists if there is a delay in
loading a bottle into the instrument and growth has already occurred.
2. Place the bottles upright on the conveyor belt of the A unit.
WARNING
The potential consequence of a delayed result exists if a bottle is
loaded upside down on the conveyor.

Figure 40: Correct Bottle Placement for Loading Bottles
3. As the bottle moves through the indexer, the imager scans the bottle label and
decodes bottle information from the 1D and 2D barcodes. The instrument also reads
up to two user applied barcodes .
Note: If necessary, you can improve a poor quality bottle image by unloading and reloading
the bottle. The bottle image is updated upon reload.
Figure 41: Example of Scanned Bottle Image
4. The indexer will move the bottle to the load position or transfer the bottle to the next
instrument for loading.
5. The robot arm (gripper) retrieves the bottle from the bottle indexer and loads the bottle
into an available cell.
The available capacity of the bank is updated on Available Cells.
6. Before leaving the instrument, verify that the instrument is operating properly and that
the bottles remain upright and are being properly loaded into the bottle indexer.

Unloading Bottles Automatically Basic Functions
WARNING
If correct loading is not verified, bottles may not be loaded into the
instrument, resulting in delayed patient results.
If the instrument identifies the bottle as a new bottle, a bottle record is created. View
the scanned bottle image and bottle information in the bottle record.
IMPORTANT: If a bottle cannot be scanned and identified, the bottle is loaded in the
instrument as an anonymous bottle and an alert appears. A bottle record is
created.
WARNING
Subculture any bottle that is reloaded anonymously. The
consequences of failing to subculture may be incorrect results.
WARNING
Never reload bottles anonymously. The consequences of not following
these instructions may be false negative results.
IMPORTANT: If an alarm or alert appears, select the applicable alarm or alert icon in Zone 2
and follow the instructions on the screen to resolve the issue. If the problem
persists, contact your local bioMérieux Representative.
CAUTION: Pace yourself and be mindful of awkward physical

movements during periods of high workload to reduce fatigue and the
potential for repetitive motion injury.
Unloading Bottles Automatically
The instrument automatically unloads all identified positive and negative bottles from any
instrument in a bank when the instrument is configured to automatically unload bottles after
testing and a final test result is available.
Anonymous bottles must be identified before they can be automatically unloaded.
WARNING
Process unloaded bottles in a timely manner. The consequences of delays
may be no results.

Unloading Positive Bottles Automatically Basic Functions
WARNING
Remove positive bottles in a timely manner. The consequences of delays
may be delayed results.
WARNING
Be sure to account for any bottles that are removed from the system. The
consequences of not accounting for bottles removed from the system may
be missed or delayed results.
Fully remove a bottle from the return chute. If a bottle is only partially removed, the bottle may
appear to the instrument to be completely removed. The result may be that multiple bottles
unload into that chute. If three bottles stack up, and the bottom bottle is not touching the
sensor, the return chute jam alarm sounds.
CAUTION: Never force a bottle back into an empty return chute after it has
been previously or partially unloaded. The consequences may be delayed
results.
WARNING
Always open the cabinet and check for dropped bottles inside the instrument
when a bottle does not reach its intended destination. The consequences of
a missed bottle may be delayed or no results.
Automatic unloading stops and an alarm appears in the following situations. Resolve the
alarm to continue automatic unloading.
• Waste container is full.
• Waste container is missing.
• Bottle retrieval area is full.
• Robot jam or other instrument malfunction occurs.
Unloading Positive Bottles Automatically

Positive Bottles indicates the final result is positive. All identified positive bottles are
automatically removed from the cells and transfer to the bottle retrieval area to stop
incubation when the instrument is configured to automatically unload bottles.
After the positive bottles are removed from the bottle retrieval area, the positive bottle counts
update, and the unload events record in the audit log.
The bottle status changes to Unloaded after the bottle is removed from the bottle retrieval
area.
Note: Up to three bottles can unload to each chute in the retrieval area at one time. No additional
positive bottles can unload from the cells until the other bottles are removed from the
retrieval area.

Unloading Negative Bottles Automatically Basic Functions
Unloading Negative Bottles Automatically

Negative Bottles indicates the final result is negative. All identified negative bottles
automatically unload from the cells and transfer to the waste container when the instrument is
configured to automatically unload bottles.
The instrument capacity and the number of negative bottles update. The unload events are
recorded in the audit log.
The bottle status changes to Unloaded after the bottles transfer to the waste container.
Canceling a Bottle Test

Use either the Search Results screen or the Bottle Status Information screen to cancel a
bottle test.
1. Select Delete.
Figure 42: Delete Icon

3. Select OK.
The Delete Bottle warning appears.
Figure 43: Delete Bottle Warning
4. Select OK.
WARNING
Canceling a bottle under test may lead to no result.
The test is canceled, and the bottle unloads to the bottle retrieval area.
Note: Bottles that have been canceled using Delete cannot be re-loaded on to the
instrument.
Figure 44: Test Canceled

Handling Unconfirmed Positive Bottles Basic Functions
Handling Unconfirmed Positive Bottles

Smear and subculture all bottles determined positive by the system.
The system algorithm is looking for the organism's log phase growth curve. If a positive bottle
is reloaded at the end of, or after, the log phase growth curve, the bottle may or may not be
flagged positive again. Therefore, true positive bottles that are reloaded may or may NOT flag
positive on the system again. The subculture made at the initial positive flag should be relied
upon for culture results.
The following should be considered when reloading a false positive bottle:
• If no bottle readings were taken after the initial positive signal, the bottle will revert back to
negative-to-date and continue testing.
• If bottle readings were taken after the initial positive signal and the bottle was not
unloaded, then the algorithm will analze the additional readings. If the readings still
support a positive bottle status then the result will remain positive. If the additional
readings do not support a positive signal then the bottle status will revert back to negative-
to-date and continue testing.
If a Gram stain of a positive bottle reveals no microorganisms, subculture the bottle and
reload it to continue testing.
1. When a bottle previously called positive is reloaded, a message states that the bottle
result may be reset to negative to date and may be flagged as unconfirmed positive.
Select an option:
• OK to continue.
• Cancel to cancel the action. The bottle result remains positive.
2. Login to the system.
3. If growth appears on the subculture, access the Edit Bottle Record screen and
change the bottle test result to Positive.
Note: If a reloaded positive bottle signals positive a second time, that bottle cannot be
reloaded.
WARNING
A potential hazard (false negative test result) exists if a bottle is
reloaded into a different bank at the site. Bottles can only be moved
between banks in Primary/Secondary site configuration.
WARNING
A potential hazard (incorrect test result) exists if the bottle is not
reloaded in a timely manner.
Unloading Bottles by User Request
When the instrument is configured to unload bottles by user request, the instrument unloads
positive and negative bottles in two ways:
• Unload all positive or negative bottles that have a final test result.
• Unload specific bottles through a user-selected search.

Unloading Positive and Negative Bottles by User Request Basic Functions
Note: Anonymous bottles must be resolved before unloading.
WARNING
A potential hazard (false negative test result) exists if a bottle is removed
from the instrument before testing is complete.
WARNING
Failure to subculture any negative to date bottle that is out of the instrument
longer than the missed readings period may lead to a hazard of incorrect
results.
Unloading Positive and Negative Bottles by User Request

From the Home screen:
1. Select one:
• Positive Bottle Unload
• Negative Bottle Unload
Figure 45: Unloading by User Request
2. Enter your user name and password, if required based on configuration.

The instrument unloads all positive bottles or all negative bottles, as requested.
WARNING
If a negative bottle completes the protocol, the bottle is not unloaded,
and analysis continues, the bottle result could change from negative
to positive. If a report is printed before unloading negative bottles, the
report may contain incorrect results.

Unloading Specific Bottles by User Request Basic Functions
Unloading Specific Bottles by User Request
CAUTION: For optimal results, bottles should remain testing within the same
instrument or bank where they were originally loaded until the test is
complete. Bottles with a negative-to-date result should not be unloaded or
relocated to a different instrument. This action interrupts bottle readings and
may cause a delay in positive determination or an inaccurate result. Only if
necessary, follow the instructions below to unload or relocate a bottle with a
negative-to-date result.
From the Search Results screen:

1. Select the bottles to unload from the search results table.
2. Select Unload.
The Unload Bottle confirmation message appears.
3. Enter your user name and password, if required based on configuration.
4. Select OK.
The instrument unloads the selected bottles to the bottle return chutes.
Note: Unload is also available from the Bottle Status Information screen and the Edit Bottle Record
screen.
Canceling the Bottle Unload Request

1. Select Cancel Unload.
Note: If you select Cancel Unload as a bottle is being removed from its cell, the instrument
unloads the bottle, and then cancels the remaining bottles to be unloaded.
2. Remove the unloaded bottles from the bottle retrieval area.
Managing Bottle Information
The instrument manages bottle information with the following options:

• Access bottle records based on specific search criteria.
• Edit bottle data.
• Print bottle information.
• Generate instrument temperature and calibration reports.
• Generate bottle reports.
Note: Bottle data may not associate to the accession ID or to the patient if the data in the LIS
message is invalid (such as an invalid birth date or maximum testing time). Correct the data
in the LIS and resend the message.
Data Retention Period for Bottle Information

The instrument provides access to bottle images and graphs for up to four weeks after the
associated bottle has been removed from the system. Other bottle data is available for the

Searching for Specific Bottle Information Basic Functions
time period configured in the Data Retention/Accession Reuse setting. For more
information about this setting, see Configuring Data Retention and Accession ID Reuse.
Searching for Specific Bottle Information

Search for bottle data based on specific search criteria such as accession ID, bottle ID, load
status, or bottle result.
Figure 46: Search Screen
1 Search button
2 Search criteria
3 Search for bottle information button
4 Clear search criteria button
5 More button (Displays additional search criteria)
IMPORTANT: Multiple search criteria can be selected.
Searching by Patient ID
Note: Patient data can be deleted from the system. All bottles associated to the patient must be
canceled first, see Canceling a Bottle Test, then contact your local bioMérieux representative
to delete the patient.
From the Search screen:

1. Next to Patient ID, enter a partial or full patient ID and then click Search.

Searching by Patient Name Basic Functions
Figure 47: Search - Patient ID
If more than one patient ID is found, the search results are displayed in a table.
2. From the search results, select your desired patient ID.
Figure 48: Search Results - Patient ID
Searching by Patient Name

1. Select Add Search Criteria for the patient.
Figure 49: Add Search Criteria Button

Searching by an Accession ID Basic Functions
Figure 50: Add Search Criteria - Patient Name
1 Patient last name field

2 Patient first name field
3 Search button
4 Clear search criteria button
5 OK button
6 Cancel button
2. Enter the Last Name. Enter the entire name or a portion of the name consisting of the
first letter or letters. Entering only "S" returns all names that begin with "S."
Search and Clear buttons are enabled.
Note: Select Cancel to close the Add Search Criteria screen and return to the Search
screen.
3. Select Search.
4. Select the patient name from the list.
5. Select OK.
The Search screen shows the patient name.
6. Select Search.
See Accessing the Bottle Status Information Screen.
Searching by an Accession ID
1. Select Accession ID.
2. Enter the accession ID.
3. Click the Search for Bottle Information button.
Searching by a Bottle ID
1. Select Bottle ID.
2. Enter the bottle ID.
3. Select Search for Bottle Information.

Searching by the Load Status Basic Functions
Note: To search for all bottles that have a bottle ID with the same first two characters (for
example, SA), enter the first two characters using the on-screen keyboard. In this
example, all bottles with a bottle ID that starts with SA would be listed.
Searching by the Load Status

1. Select a Load Status checkbox.
• Loaded (bottle is currently loaded)
• Unloaded (bottle is currently unloaded)
Note: To deselect an option, select the checkbox again.
Searching by the Bottle Result

1. Select a Bottle Result checkbox.
• Positive
• Negative
• Negative to Date
Searching by the Bottle Type

1. Select Add Search Criteria
Figure 51: Add Search Criteria - Criteria Values for Bottle Type
1 Available criteria values for bottle types
2 OK button

Searching by Missing Information Basic Functions
3 Cancel button
2. Select the checkbox next to the bottle type.
3. Select OK.
The selected bottle types appear in the Bottle Type field.
Searching by Missing Information

Search for all anonymous bottles (bottles loaded without a bottle ID or bottle type), bottles
loaded without an accession ID, or bottles loaded without patient information.
1. Select a Missing Information checkbox.
• Anonymous
• Accession ID
• Patient

WARNING
The potential for delayed result exists if missing accession IDs
(orphan) or anonymous bottles are not properly handled and
addressed.
Including Bottles with Canceled Test in Search

1. Select the Include Canceled Tests checkbox.
2. Select Search for Bottle Information
Using Additional Search Criteria

Use the following additional search criteria to perform a more extensive search for bottle
information:
• Sample type (Standalone and MAESTRIA™ site configuration only)
• Lot number
• Expiration date
• Load date
• Unload date
• Instrument name
• Bottle result date
• Sample volume
• Bottle location
• Bottle indicators
• Unconfirmed positive

Searching by Sample Type Basic Functions
Note: Depending on your configuration, some of the search criteria may not be available.
Note: The default setting for dates is the current date.
Figure 52: Additional Search Criteria Fields
1. Click the More button to display additional search criteria fields.

2. Click the More button again to collapse the additional search criteria fields.
Searching by Sample Type

1. Enter the Sample Type.
Note: The text field is not case sensitive. For example, searching by blood or Blood will
return the same results.
2. Optional: Select the Negation checkbox if searching for a Sample Type other than
what is entered in the Sample Type field.
Deselect the Negation checkbox if searching for the Sample Type that is entered in
the Sample Type field.
Figure 53: Negation Checkbox
3. Click Search for Bottle Information.
Search Examples
Scenario 1: Search for bottles that have a Sample Type that is blood.

Searching by Lot Number Basic Functions
Enter blood in the Sample Type field. Click Search for Bottle Information.
Results are displayed that have a Sample Type of blood.
Figure 54: Search Results - Sample Type is Blood
Scenario 2: Search for bottles that have a Sample Type that is not blood.
Enter blood in the Sample Type field. Select the Negation Checkbox to
search for bottles that have a Sample Type that is not blood. Click Search for
Bottle Information. Results are displayed that do not have a Sample Type of
blood.
Figure 55: Search Results - Sample Type is Not Blood
Searching by Lot Number

1. Enter the Lot Number.
2. Click Search for Bottle Information.
Searching by Expiration Date

From the Calendar screen:
1. Select the Expiration Date.
2. Click OK to save your search criteria.
Searching by Load Date

1. Select the start date.
2. Optional: Select a starting time.
3. Select the end date.
4. Optional: Select an ending time.
5. Select OK to save your search criteria.

Searching by Unload Date Basic Functions
Searching by Unload Date

5. Select OK to save your search criteria.
Searching by Instrument Name

From the Add Search Criteria screen:
1. Select the Instrument Name.
Figure 56: Add Search Criteria - Instrument Name
1 Instrument name
2 Instrument name checkbox

The selected instrument names appear in the Instrument Name field.
Searching by Bottle Result Date

Searching by Sample Volume

1. Select one or more of the following options:
Option Description
Properly Filled The sample volume measures within the configured range.
Overfilled The sample volume exceeds the configured maximum.

Searching by Bottle Location Basic Functions
Option Description
Underfilled The sample volume falls below the configured minimum.
Unknown The bottle was loaded before the instrument was updated to
software release 3.1.
Unable to Read The sample volume could not be read when the bottle was loaded
because there is no fill-to line on the bottle, the fill-to line is
obstructed, or the bottle is anonymous.
Pending The sample volume could not be read when the bottle was loaded -
for example, because there was foam in the bottle and the bottle
was scheduled for rescan within 2 hours of loading.
Not Supported The bottle type does not support a fill-to line.
Disabled Sample volume measurement is disabled.
Label Issue The sample volume could not be read when the bottle was loaded
because a label is obstructing the area around the fill-to line. For
correct label placement, see Applying a Barcode Label to a Bottle
Figure 57: Add Search Criteria - Sample Volume

Searching by Bottle Location

1. Select the rack.

Searching by Bottle Indicators Basic Functions
Figure 58: Add Search Criteria - Bottle Location
2. Select the cell.

Note: To narrow this search to one instrument in multi-instrument configurations, select the
instrument of interest in addition to rack and/or cell.
Searching by Bottle Indicators

1. Select one or more of the following options.
• Subculture Recommended
• Expired
• Contaminated (if configured)
• Non-Authentic (if configured)

Searching by Unconfirmed Positive Basic Functions
Figure 59: Add Search Criteria - Bottle Indicators

Searching by Unconfirmed Positive

1. Select the Unconfirmed Positive checkbox.
Search Results Screen

The Search Results screen displays the following information in a table:
• Accession ID
• Bottle ID
• Patient ID (if configured)
• Bottle result
• Bottle type
• Load status
• Bottle location, including instrument, rack, and cell (e.g., 1-A2)
• Sample volume
• Total number of items returned in a search
Note: Search criteria are displayed above the table

Accessing the Bottle Status Information Screen Basic Functions
Figure 60: Example of Search Results Screen
Note: Use the Page Scroll buttons at the bottom of the screen to access additional search results.
Accessing the Bottle Status Information Screen

1. Select the corresponding checkbox in the left column for bottles to view.
2. Select View.
The Bottle Status Information screen appears with all information related to the
selected bottle.
Figure 61: Bottle Status Information Screen
Note: If more than one bottle was selected, use the Page Scroll buttons at the bottom of the
screen to access the bottle status information for the additional bottles.
The table describes the buttons and symbols on the Bottle Status Information screen
and their functions.

Accessing the Bottle Status Information Screen Basic Functions
Table 9: Bottle Status Information Icons

History Display the Bottle History screen.
Image Display an image of the scanned bottle.
Edit Display the Edit Bottle Record screen.
Graph Display the Bottle Graph screen.
Unload Unload the bottle. This button is enabled only

when the bottle is loaded.
Print Print the bottle status information.
Upload Upload bottle information to the bioMérieux

middleware or to the LIS (based on system
configuration).
Delete Cancel the bottle test.
Close Close the Bottle Status Information screen.
Notification • Next to an expiration date, the indicator

Indicator means the bottle has reached its
expiration date.
• Next to a sample volume, the indicator
means the measured volume is outside
the user-configured sample volume
variance.
• Next to a bottle result, the indicator means
a subculture is recommended for the
bottle.

Editing a Bottle Record Basic Functions

Text Entry Indicator The value has been user-entered.
Revert Reverts a user-entered value to the value

originally determined by the instrument.
3. (Site configuration only) If necessary, click the Upload button on the Bottle Details
screen to view patient demographic information.
Note: In site configuration, there may be a delay in the transfer of patient demographic
information from the bioMérieux middleware to BACT/ALERT® VIRTUO® while bottles
are processing. When the bottle results are final, patient demographic information
downloads to BACT/ALERT® VIRTUO®.
Editing a Bottle Record

Edit the following information from the Edit Bottle Record screen:
• Bottle ID
• Bottle type
• Accession ID
• Maximum test time (Days)
• Bottle result
• Unconfirmed positive
• Lot number
• Expiration date
• Patient information (based on configuration)
• Contamination (based on configuration)
Note: Any edits made to the bottle record will override any information supplied by the LIS.
WARNING
Assigning bottle record information by using multiple methods may lead to
incorrect results.
WARNING
Always save the desired changes when editing a bottle record. Failure to
save the changes may cause incorrect results.
WARNING
If a physical keyboard is installed, be sure it matches the language of the
system installed. Failure to install a keyboard in the configured language
may cause delayed results.

Editing Patient Information Basic Functions
Note: Fields that cannot be edited are gray.
Note: The Bottle ID, Bottle Type, Lot Number, and Expiration Date cannot be edited if the
information was read from a scanned bioMérieux bottle code when loaded.
Figure 62: Example - Edit Bottle Record Screen
WARNING
If you must use alternate bottle IDs during Edit, the IDs must be unique for
the duration of your data retention period. Duplicating alternate bottle IDs
within this time period can result in incorrect results.
Editing Patient Information
Note: The ability to edit patient information is only allowed if the instrument is configured as
Standalone without an LIS connection.
From the Edit Bottle Record screen:

1. If the bottle record does not include an accession ID, enter an accession ID and then
click Look Up to display associated patient information.
If the instrument is unable to read the accession ID from the bottle, enter it manually to
resolve the bottle. See Scanning Barcodes from a Work List.
WARNING
The consequences of inadvertently clearing an accession ID may be
delayed results.

Editing Patient Information Basic Functions
Figure 63: Edit Bottle Record - Accession ID Entered
2. If the accession ID is not associated with patient information, enter a patient ID and
click Look Up to display the associated patient name.
Figure 64: Edit Bottle Record - Accession ID Not Associated with Patient
Figure 65: Edit Bottle Record - Patient ID Entered
3. If the patient ID is not associated with a patient name, enter the patient's last name
and first name if desired.
Figure 66: Edit Bottle Record - Patient Name Entered
4. Click Save.

Scanning Barcodes from a Work List Basic Functions
Scanning Barcodes from a Work List

If the instrument is unable to read the accession ID or bottle ID from the bottle, enter it
manually to resolve an orphan (no accession ID) or anonymous (no bottle ID) bottle.
1. Locate the bottle on your work list.
2. Place the cursor in the appropriate field (accession ID or bottle ID) on the Edit Bottle
Record screen.
3. Place the appropriate barcode on the work list under the barcode scanner below the
Large Display on the front of the instrument.
Note: The scanner does not provide an audible indication when a barcode has been
scanned.
Changing the Maximum Test Time

1. In the Max Test Time (Days) field, enter a test time value from 0.5 to 70 in increments
of 0.5 days.
Save and Cancel are now active. Revert appears next to the field.
2. Select Save.
WARNING
Failure to properly follow instructions for reducing maximum test time
may cause false negative results.
WARNING
Failure to properly follow instructions for correctly increasing
maximum test time may cause delayed or negative results.
Note: See the appropriate bottle Instructions for Use for specific maximum test time
recommendations.
Editing the Bottle Result

Select one of the following test result options:
• Positive
• Negative
Save and Cancel are now active. Revert appears when the bottle result is changed
manually. Select Revert to change back to the result determined by the instrument.
WARNING
Failure to properly follow instructions for changing bottle test results
may lead to incorrect results.

Processing Expired Bottles Basic Functions
WARNING
A potential hazard (incorrect test result) exists if the wrong test status
is assigned.
Processing Expired Bottles
WARNING
bioMérieux shall not be liable as to any defect (including, but not limited to,
incorrect results that may affect patient outcomes or cause a loss of product)
arising from the use of expired bottles, or the communication of the results
obtained using expired bottles. Users who use expired bottles do so at their
own risk.
Note: Only a user with LabSuper access is authorized to process expired bottles. See Managing
User Accounts and User Groups.
When the bottle expired alarms sounds, the following message appears:
Figure 67: Expired Bottle Loaded Message
Select one.
• Select Continue Test to release results on all expired listed in the Expired Bottle
alarm. The bottle results indicate that the bottles are expired.
• Select Cancel Test to cancel processing and unload all bottles that are listed in the
alarm as expired.
Note: The alarm message remains on the screen and the Large Display cannot be used
until the alarm is addressed. All currently loaded bottles are not affected and continue
to process, but other functions are not accessible.

Reloading Positive Bottles Basic Functions
Once the alarm is addressed, the message disappears and the Large Display is
accessible.
Reloading Positive Bottles

If a Gram stain of a positive bottle reveals no microorganisms, subculture the bottle and
reload it to continue testing. When the positive bottle is reloaded and scanned, the Positive
Bottle Reloaded message appears.
From the Positive Bottle Reloaded message:
Select one of the following options:
• Select OK to reload the bottle.
CAUTION: The bottle will be reanalyzed, which may change the

status from positive to negative to date and flag the bottle as
unconfirmed positive accordingly. If reanalysis determines the
bottle to be positive, the status remains unchanged and the bottle
is not flagged as unconfirmed positive.
• Select Cancel to cancel the reload. The bottle status will remain positive and the
bottle will be unloaded.
Figure 68: Positive Bottle Reloaded
Note: A user name and password are required to resolve the reload positive message.

Identifying an Anonymous Bottle Basic Functions
Note: A positive bottle can only be reloaded once for reanalysis.

A bottle is flagged positive when the instrument finds one reason for a positive result.
If reloaded, the bottle's past readings are analyzed again, resulting in one of the
following outcomes:
• If reanalysis confirms there is only one reason for a positive result, the bottle result
changes back to negative to date.
• If reanalysis finds a second reason for a positive result, the bottle result changes to
positive again. If reloaded again, the bottle result will not change back to negative
to date and further testing must be completed off-line.
Identifying an Anonymous Bottle
If a bottle is loaded into the instrument without being identified (because of a hardware
malfunction or damage to the bottle label), the bottle is called an anonymous bottle because it
is not associated with a bottle ID or bottle type. Identify an anonymous bottle to ensure that
the bottle is correctly associated with the patient.
WARNING
Address anonymous positive bottles immediately to ensure correct results
are reported. Failure to address anonymous positive bottles immediately
may lead to delayed results.
WARNING
Be sure to identify anonymous bottles before unloading from the instrument.
Identifying an Anonymous Bottle with a Visible bioMérieux Label

Follow these steps to identify an anonymous bottle where the bioMérieux bottle ID number is
visible from the bottle image.
1. Select the anonymous bottle alert.
Note: Another option is to use the Search function to locate anonymous bottles. See Using
Additional Search Criteria.
2. Enter your user name and password, if not already logged in.
3. Select OK.
Anonymous bottles appear one record at a time for editing. Navigate to the next
record, if necessary.
WARNING
Failure to unload anonymous bottles one at a time may lead to
incorrect results.

Identifying an Anonymous Bottle without a Visible bioMérieux Label Basic Functions
Figure 69: Anonymous Bottle Record
4. Enter the bottle ID from the bottle image.

The bottle type is determined from the bottle ID prefix and automatically appears in the
Bottle Type field.
5. Select Save.
6. Add an accession ID, if required.
7. Select Save
WARNING
Associating a bottle with the incorrect accession ID may lead to
incorrect results.
WARNING
A potential hazard (false negative test result) exists if the algorithm
does not have sufficient information to calculate the correct bottle test
result.
Note: If an anonymous bottle is reloaded (for example, an unconfirmed positive), the bottle
remains anonymous. When identified, the two data records are not combined. Do not
unload the bottle at this time. The bottle continues to process.
Note: The bottle result may change after saving the bottle type.
Identifying an Anonymous Bottle without a Visible bioMérieux Label

Follow these steps to identify an anonymous bottle where the bioMérieux bottle ID number is
not visible from the bottle image. To follow this procedure, use a scannable barcode label
such as the generic barcode labels available from bioMérieux.
1. Select the anonymous bottle alert.

Identifying an Anonymous Bottle without a Visible bioMérieux Label Basic Functions
Note: Another option is to use the Search function to locate anonymous bottles. See Using
Additional Search Criteria.
3. Select OK.
Anonymous bottles appear one record at a time for editing. Navigate to the next
record, if necessary.
WARNING
Failure to unload anonymous bottles one at a time may lead to
incorrect results.
4. Obtain a scannable bottle ID barcode, either generic or other type.

5. Enter or scan the bottle ID from the barcode into the bottle ID field.
Figure 70: Generic Bottle ID
6. Select Save.
7. Enter a bottle type, if it is visible on the image.
8. Select Save.
9. Select Unload to unload and relabel the bottle. To continue unloading and relabeling
this bottle, see Unloading, Relabeling, and Reloading a Previously Identified
Anonymous Bottle.
Figure 71: Unload and Relabel Bottle
Note: If the bottle type is not visible on the image, enter the bottle type once the bottle is
unloaded and the bottle type is determined.

Unloading, Relabeling, and Reloading a Previously Identified
Anonymous Bottle Basic Functions
Note: The bottle result may change after saving the bottle type.
WARNING
Incorrectly associating a bottle record may lead to incorrect results.
When an anonymous bottle has been identified as described above, see Unloading,
Relabeling, and Reloading a Previously Identified Anonymous Bottle to understand the
sequence of events to unload this bottle.
Unloading, Relabeling, and Reloading a Previously Identified Anonymous Bottle
It is not necessary to unload and relabel a bottle if the bottle ID and bottle type could be
determined from the image and were entered into the bottle record. If a bottle has no image or
has an obstructed barcode, remove the obstruction or relabel the bottle.
1. Select Unload.
2. Select OK.
The bottle returns to the bottle retrieval area.
Note: The bottle may also automatically return to the bottle retrieval area if it is determined
to be positive.
3. Remove the bottle from the bottle retrieval area.

An alert indicating that a label is required displays within a few seconds of removing
the bottle from the bottle retrieval area.
Figure 72: Bottle Label Required
4. Ensure that the bottle ID barcode is present and correct any obstructions, if possible.
5. If the barcode obstruction cannot be corrected, affix a scannable barcode label to the
bottle.
6. If the bottle ID in the bottle record does not match the bottle ID in the affixed barcode,
select Edit.

Alternate Bottle IDs Basic Functions
WARNING
The bottle ID on the label must match the bottle ID entered in the
record.
WARNING
Failure to affix the corresponding barcode label or to remove any
obstruction of the barcode label before reload will cause the reloaded
bottle to be anonymous.
WARNING
Bottle IDs must be unique, and must be unique for the duration of the
data retention period on their BACT/ALERT® VIRTUO® system. Do not
reuse a bottle ID within the data retention period as duplicate bottle
IDs can lead to false negative results.
7. Enter the bottle ID from the affixed barcode in the bottle ID field.
8. Select Save.
9. Reload the bottle by placing it on the conveyor.
10. Select Dismiss to close the message and resolve the alert.
11. Wait for the Bottle(s) Successfully Reload confirmation message.
Figure 73: Bottles Successfully Loaded
12. Select Dismiss to close the message and resolve the alert.
Alternate Bottle IDs
An alternate bottle ID is a barcode for bottle ID replacement and is usually created by a LIS.

Viewing and Printing a Bottle Label Image Basic Functions
WARNING
If you use alternate bottle IDs, the IDs must be unique for the duration of
your data retention period. Duplicating alternate bottle IDs within this time
period can result in delayed or inaccurate results.
Viewing and Printing a Bottle Label Image
Note: A bottle label image is available for four weeks after the associated bottle has been unloaded
from the instrument.

1. Select bottle records.
2. Select View.
3. Select Image.
The image of the bottle label appears.
4. Select Print.
The print preview of the bottle label appears.
5. Select Print again.
The record of the bottle label prints.
Zooming and Rotating a Bottle Label Image
From the Bottle Image or Edit Bottle Record screen:

1. Select the bottle label image.
The bottle image zooms in.
Figure 74: Bottle Label Image

Viewing and Printing Records for Unloaded Bottles Basic Functions
1 Bottle label image

2 Rotate clockwise
3 Rotate counterclockwise
2. Select the bottle label image again.
The bottle label image zooms out.
3. Select Rotate Clockwise.
The bottle label image rotates clockwise.
4. Select Rotate Counterclockwise.
The bottle label image rotates counterclockwise.
Viewing and Printing Records for Unloaded Bottles

1. Select Unloaded.
2. Select a date range from Add Search Criteria.
3. Select Search.
The Search Results screen appears.
4. Select View.
5. Select Print.
Viewing a Bottle Graph
Note: A bottle readings graph is available for four weeks after the associated bottle is unloaded
from the instrument.
From the Bottle Status Information screen:

1. Select Graph.
Figure 75: Bottle Readings Graph - (7.0 Days)
1 Positive curve
2 Print button

Viewing and Printing Reports Basic Functions
3 Zoom in button
4 Close button
5 Time (In days)
6 Bottle reflectance readings
2. Select Zoom In to display an expanded view of the readings.
Note: Zooming into a graph provides an expanded view of bottle readings in a given area of
the graph. When zooming in, always refer back to the full graph.
Zooming in automatically adjusts the X and Y axis to fit the available data.
Figure 76: Bottle Readings Graph - Time (2.25 Days)
1 Positive curve
2 Print button
3 Zoom out button
4 Close button
5 Time (In days)
6 Bottle reflectance readings
3. Optional: Select Print.
Viewing and Printing Reports

1. Select Reports.

Bottle Reports Basic Functions
Figure 77: Reports Screen
2. Generate the desired report.
Bottle Reports
The following bottle reports are available.
• Positive Bottles
• Negative Bottles
• Negative to Date Bottles
• Orphan Bottles
• Anonymous Bottles
• Loaded Bottles
Generating Bottle Reports in Standalone and Site Configuration (MAESTRIA™)
IMPORTANT: The following procedure for generating bottle reports is for instruments in standalone
and site configuration (MAESTRIA™) only.
From the Reports screen:

Select the desired report.
Figure 78: Bottle Reports Screen
Note: Standalone Bottle Reports can be configured in the System Configuration Report tab.

Generating Bottle Reports in Standalone and Site Configuration
(MAESTRIA™) Basic Functions
Figure 79: Positive Bottles Report
1 Calendar button
2 Refresh button
3 Export button
4 Print button
5 Close button
6 Page Scroll buttons
The Positive Bottles Report includes the following features.

• Displays bottles that were determined positive within 24 hours of the report's
creation.
• Displays the total number of bottles listed on the report.
• Allows the user to export the report to a .csv file.
• Allows the user to change the bottle result dates displayed on the report.
• Allows the user to sort bottles in a column by tapping the column header.
Figure 80: Negative Bottles Report
The Negative Bottles Report includes the following features.

• Displays bottles that were determined negative within 24 hours of the report's
creation.
• Allows the user to change the bottle result dates displayed on the report.

Generating Bottle Reports in Standalone and Site Configuration
(MAESTRIA™) Basic Functions
Figure 81: Negative to Date Bottles Report
The Negative to Date Bottles Report includes the following features.

• Displays bottles that are currently loaded with a Negative to Date status.
• Allows the user to change the load dates displayed on the report.
Figure 82: Orphan Bottles Report
The Orphan Bottles Report includes the following features.

• Displays bottles that are currently loaded and missing an accession ID.
Figure 83: Anonymous Bottles Report
The Anonymous Bottles Report includes the following features.

• Displays bottles that are currently loaded and missing a bottle ID and/or bottle type.

Generating Bottle Reports in Site Configuration (MYLA®) Basic Functions
Figure 84: Loaded Bottles Report
The Loaded Bottles Report includes the following features.

• Displays bottles that were loaded during the previous day.
Generating Bottle Reports in Site Configuration (MYLA®)
IMPORTANT: The following procedure for generating bottle reports is for instruments in site
configuration (MYLA®) only.
Note: There may be a slight delay as the instrument communicates with bioMérieux middleware
when accessing the reports for the first time.
Note: The Critical Information icon may disappear from the Bottle Reports screen when a bottle is
unconfirmed positive. You can locate this information on both the Bottle Details screen and in
the PDF report.

1. Select the bottle report.
Figure 85: Positive Bottles Report

1 Calendar buttons
2 Sorting arrows
3 Critical Information icon
4 Search button
5 Refresh button
6 Print button
7 Expand and collapse button
The Positive Bottles Report includes the following features:

• Displays the total number of bottles that were determined positive the current day.
• Provides bottle details including bottle alerts.
• Filters bottles that turned positive within an hour range and functions as a checklist
for unloading bottles.
• Filters by time frames to see only the positive bottles for a given shift.
• Filters bottles that are anonymous and orphan.
Figure 86: Negative Bottles Report
The Negative Bottles Report includes the following features:

• Displays the total number of bottles that were determined negative the current day.
• Provides bottle details including bottle alerts.
• Filters bottles that turned negative within an hour range and functions as a checklist
for unloading bottles.
• Filters by time frames to see only the negative bottles for a given shift.
• Filters bottles that are anonymous and orphan.
Figure 87: Bottles in Progress Report
1 Trash Button
The Bottles in Progress Report lists bottles that are currently loaded with a Negative to
Date status.

The Trash Button is available on some reports. To remove a line from the report, select
the line, then select Trash.
Figure 88: Orphan Bottles Report
Note: An orphan bottle is:

• A bottle that does not have an Accession ID associated with an LIS provided order
when interfaced to an LIS, or
• A bottle that does not have an Accession ID, when not interfaced to an LIS
The Orphan Bottles Report includes the following features.

• Displays the total number of orphan bottles currently loaded.
• Provides bottle details.
Figure 89: Anonymous Bottles Report
Note: An anonymous bottle is a bottle without a bottle ID or bottle type.
The Anonymous Bottles Report includes the following features

• Displays the total number of anonymous bottles currently loaded.
• Provides bottle details.

Instrument Reports Basic Functions
Figure 90: Loaded Bottles Report
The Loaded Bottles Report includes the following features.

• Displays bottles loaded within the previous 24 hours.
• Filters bottles loaded within an hour range and provides option to verify that all
cultures ordered by the LIS have been received and loaded.
• Filters bottles that are loaded with a positive status and/or negative status and
functions as a checklist for unloading bottles.
• Filters bottles that are orphans or anonymous bottles and functions as a checklist
for assigning bottles to accession numbers.
2. Select one or more of the following options.
• Select the Calendar buttons to select the date range to search.
• Select the Up and Down arrows to sort records.
• Select Critical Information to view critical information about records.
• Select Search to search for selected criteria.
• Select Refresh to refresh records.
• Select Print to print records.
• Select Delete to remove the row from the report (not available on all reports).
The Print Preview screen appears with the report.
3. Select Export then select Download to save the record to local media or a remote
location.
Instrument Reports
Instrument reports contain incubator temperature and calibration information based on a date
range.
Three instrument reports are available.
• The Hourly Temperature Detail Report provides information about hourly temperature
readings in the instrument including trends in the temperature readings.
• The Daily Average Temperature Report provides information about daily temperature
readings in the instrument.
• The Instrument Calibration Report provides information about calibration events over a
period of time.

Generating an Hourly Temperature Detailed Report Basic Functions
Generating an Hourly Temperature Detailed Report

1. Select Temperature.
2. Select Hourly Temperature Detail Report.
Figure 91: Hourly Temperature Detail Report
1 Go to previous month and year
2 Go to next month and year
3 Selected day
4 Print
5 Export
6 Clear
7 Close
3. Select Add Search Criteria for the instrument name.

4. Select the day.
5. Select the first hour.
6. Select the last hour.
7. Select Print.
The report appears as a PDF.

Generating an Hourly Temperature Detailed Report Basic Functions
Figure 92: Hourly Temperature Detail Report
Table 10: Hourly Temperature Report
Field Description
Date Date the report was selected.
Time of Day Time of day by hours.
Average °C Average temperature during the previous
hour.
Low / High °C Low and high temperatures during the
previous hour.
In Range "Yes" if the temperature is in range
"No" if temperature is out of range
Note: Temperature is measured 30

times per hour. For a given
hour, In Range is "No" if at
least one of the 30 readings is
out of range. An out-of-range
reading may occur if the
instrument door was opened
during that hour.
Comment Space for comments.

Date Line for date the report was printed.
8. Select Export.
The report is exported as a CSV file.
9. Use the PDF functions to print the report or save the report to another location.
10. Select Download to save the report to local media or a remote location.

Generating a Daily Average Temperature Report Basic Functions
Figure 93: Print View
1 Download button
Generating a Daily Average Temperature Report

1. Select Temperature.
2. Select Daily Average Temperature Report.
Figure 94: Daily Average Temperature Report

3 Selected day
4 Print
5 Export
6 Clear
7 Close
3. Select Add Search Criteria for the instrument name.
6. Select Print.

Generating an Instrument Cell Calibration Report Basic Functions
Table 11: Daily Average Temperature Report Fields
Field Description
Date Dates in the date range.
Average °C Average temperature for that date.
Low/High °C Low and high temperatures for that date.
Out of Range/Day Number of hours on that date when the
temperature is out of range.
Note: Temperature is measured 30 times
per hour. Out of Range/Day is the
number of hours when at least one of the
30 readings is out-of-range. An out-of-
range reading may occur if the instrument
door was opened during that hour.
Comment Space for comments.

Signature Line for signature of person printing the
report.
Date Line for date the report was printed.
Figure 95: Daily Average Temperature Report PDF
7. Select Export.
The report is exported to a CSV.
9. Select Download to save the report to local media or a remote location.
Generating an Instrument Cell Calibration Report

1. Select Calibration.

Generating an Instrument Cell Calibration Report Basic Functions
Figure 96: Instrument Calibration Report

3 Selected day
4 Print
5 Export
6 Clear
7 Close
2. Select one of the following options:
• A rack in the Bottle Location Rack list
• All
3. Select one of the following options:
• A cell in the Bottle Location Cell list
• All
6. Select Print.
8. Select Export.
The report is exported as CSV.
Instrument cell calibration involves two events:
Event Description
QC check Determines whether a cell requires full
calibration. Occurs every time a bottle is
unloaded from the cell.
Full calibration Calibrates a cell using the calibration
standards. Occurs every 6 months as routine
maintenance or if the cell fails the QC check.
The instrument cell calibration report displays QC check and full calibration results for each
cell, including the date and time when the event occurred. Event results display on the report
as follows:

Capacity of the Waste Container Basic Functions
• If a cell fails the QC check, Status displays as "Out of Service," Full Calibration
Performed displays as "No," and then full calibration occurs. If a cell passes the QC
check, it is not included on the report.
• If a cell fails full calibration, Status displays as "Out of Service," and Full Calibration
Performed displays as "Yes." If a cell passes full calibration, Status displays as
"Available."
Note: "No information found" displays on-screen when no reportable calibration events occurred for
the cell(s) during the selected time period.
In the following example, the instrument cell calibration report indicates that:
• Cell M1 passed routine full calibration and is available.
• Cell M2 failed routine full calibration and has been taken out of service.
• Cell M3 failed the QC check and was taken out of service pending full calibration. The cell
then passed full calibration and became available again for loading bottles.
• Cell M4 failed both the QC check and full calibration and has been taken out of service.
Figure 97: Example – Instrument Cell Calibration Report
Note: It is unusual for cells to fail the QC check. Usually, routine full calibration keeps cells well
calibrated.
Capacity of the Waste Container
Negative bottles unload to the waste container. Alerts display when the capacity of the waste
container is full or almost full. Bottles stop unloading if the waste container is full or missing.
The waste container capacity level appears on the Small Display.
The waste bin is considered full if the weight reaches 7 kg or the bottle count reaches 50 or if
the internal waste chute is blocked open.
Emptying the Waste Container
Alerts display when the capacity of the waste container is full or almost full.
1. Pull the waste container door handle.
The waste container door is located below the bottle loading area.
2. Remove the yellow waste container from the compartment.
3. Remove the liner bag from the waste container.
4. Dispose of the bag in an approved biohazard container.

Emptying the Waste Container Basic Functions
5. Inspect the waste container and compartment for debris and sample spills.
6. If required, clean with an approved cleaning agent.
See Approved Disinfection Agents for approved cleaning agents.
7. Put a new liner bag in the waste container.
CAUTION: Use only 23- to 25-inch flat bottom biohazard liner bags in
the waste container.
8. Inspect the waste area for any bottles that may have fallen out of the waste container.
9. Return the waste container to the compartment and close the door.
10. If any alerts remain unresolved, see Resolving Alarms and Alerts

6 System Configuration
The following system configuration settings are available:

• Bottle type configuration
◦ Bottle Type
◦ Maximum test time for each bottle type
◦ Sample upper variation
◦ Sample lower variation
• Bank configuration
◦ Instrument, bank, and lab names
◦ Bank near full threshold
◦ Incubation temperature set point
◦ Waste near full threshold
◦ Time in retrieval area threshold
• Alarm and alerts sound configuration
◦ Sound type
◦ Volume, including silencing alarms and alerts
◦ Snooze period
◦ Volume off
• Alarm configuration
◦ Enable or disable alarms and alerts
◦ Configure positive bottle color (red or yellow)
◦ Maximum bottles per accession
• General software configuration
◦ Use patient data
◦ Accession ID barcode on the bottle and define a pattern
◦ Alternate bottle ID barcode on the bottle and define a pattern
◦ Patient ID barcode on the bottle and define a pattern (if configured)
◦ Measure sample volume
◦ Set the time format
◦ Data retention and accession ID reuse (standalone configuration only)
◦ Remote notification and access Notification Center Dashboard
◦ Archive bottle data including bottle graphs and images
◦ Access BCI Connect Dashboard
• Security Configuration
◦ 21 CFR 11 Configuration
◦ Unload positive and negative bottles by user request
◦ Login required for user to unload bottles
◦ Inactivity duration for automatic logout
• LIS Configuration (standalone configuration only)
◦ Use a LIS
◦ Download test orders
◦ Upload bottle results
◦ Send consolidated messages to the LIS
◦ Automatically upload positive and negative results

Accessing the Configuration Screens System Configuration
◦ Send messages to the LIS upon loading bottles

◦ Send negative to date messages to the LIS
◦ Define LIS codes for bottle results
• Bottle Report Configuration (standalone configuration only)
◦ Set the date range
◦ Add or remove columns
◦ Re-position columns on a report
◦ Sort a column in ascending or descending order
Accessing the Configuration Screens
1. Select Configuration.
2. Select the appropriate screen tab to access the associated settings.
WARNING
Configuration settings must be carefully implemented in an authorized
manner. Failure to properly address authorization of access to system
configuration settings may lead to incorrect results. Contact
bioMérieux if necessary.
The tabs for the configuration screens are across the top of the screen. A highlighted
tab indicates an active screen.
Figure 98: Configuration Tab
1 Bottle type configuration
2 Bank configuration
3 Sound configuration
4 Alarm configuration
5 General software configuration
6 Security configuration
7 LIS configuration (standalone configuration only)
8 Bottle Reports configuration (standalone

configuration only)

Configuring Bottle Type Settings System Configuration
Figure 99: Bottle Type Configuration Screen
1 Configuration screen tabs
2 Edit button
3 Save button
4 Cancel button
Configuring Bottle Type Settings
The Bottle Type Configuration screen is used to access the following:

• Bottle Type
• Max Test Time (Days)
• Sample Lower Variation
• Sample Upper Variation
From the Bottle Type Configuration screen:
1. Select the Bottle Type display menu.

Configuring the Maximum Test Time System Configuration
Figure 100: Bottle Type Selection
1 Bottle type field

2 Bottle type drop-down menu
4 Scroll bar
2. Select the appropriate bottle type.
IMPORTANT: If the drop-down menu does not display the desired bottle type, use the scroll
bar to scroll through the entire list.
Configuring the Maximum Test Time

1. Select the bottle type.
2. Select Edit.
4. Select OK.
5. Select a test time value.
Available options are 0.5 to 70 days in 0.5 day increments.
Note: The default maximum test time for BACT/ALERT® SA and BACT/ALERT® SN bottles
is 7 days.
The default maximum test time for BACT/ALERT® FA PLUS, BACT/ALERT® FN
PLUS, and BACT/ALERT® PF PLUS bottles is 5 days.
Note: Change the maximum test time for a specific bottle by editing the associated record.
Note: Changes to the maximum test time per bottle type do not impact bottles already under
test.
6. Select Save.

Sample Volume Measurement System Configuration
WARNING
Failure to follow appropriate bottle instructions for use for reducing
maximum test time may cause false negative results.
Note: Failure to save the desired changes to the bottle configuration settings may lead to
false results.
Sample Volume Measurement

Note: Measure Sample Volume is enabled by default. It can be disabled from the General Software
Configuration screen.
Sample volume measurement is supported for the listed clinical bottle types and whole blood
samples only:
• BACT/ALERT® SA
• BACT/ALERT® SN
• BACT/ALERT® FA PLUS
• BACT/ALERT® FN PLUS
Note: Sample volume measurement is for whole blood samples only. Sample volume appears for
other sample types, but will not be supported.
When fill-to volume is enabled, any bottles with a fill-to line will include fill volumes with bottle
information. However, fill volume will not be reported if the internal imager detects foam when
the bottle is loaded. In this event, the instrument will continue to load the bottle and perform a
rescan in approximately 2 hours to measure fill volume.
WARNING
Failure to assure the correct bottle fill volume may lead to incorrect results.
Sample Volume Variation

The Sample Volume Variation is the amount of variation (in mL) from the sample volume
target. If the amount of sample added to a bottle varies too much from the sample volume
target, either higher or lower, an alert indicates that either too much sample or not enough
sample has been added to the bottle. Refer to the Instructions for Use (IFU) for the blood
culture bottles for the acceptable sample volume for the bottle types.
For example, if the lower variation is 2 mL from a sample volume target of 10 mL, an alert
displays if the sample volume falls below 8 mL. If the higher variation is 2 mL from a sample
volume target of 10 mL, an alert displays if the sample volume exceeds 12 mL.
WARNING
If the amount of sample added to a bottle varies too much from the sample
volume target, either higher or lower, incorrect test results may occur.

Setting the Sample Lower Variation System Configuration
IMPORTANT: The sample volume target (mL) is set at the factory and cannot be changed.
Figure 101: Sample Volume Lower and Upper Variation Fields
1 Sample Upper Variation field

2 Sample Lower Variation field
3 Sample Volume Target
Setting the Sample Lower Variation

2. Select Edit.
4. Select OK.
5. Select the Sample Lower Variation display menu.
Figure 102: Sample Lower Variation
1 Sample lower variation field

2 Amount display menu
4 Scroll bar
6. Select the variation amount.
Available options are 0 to 10 mL.
7. Select Save.

Setting the Sample Upper Variation System Configuration
Setting the Sample Upper Variation

2. Select Edit.
4. Select OK.
5. Select the Sample Upper Variation display menu.
6. Select the variation amount.
Available options are 0 to 10 mL.
7. Select Save.
Configuring Bank Settings
Use the Bank Configuration screen to configure settings for banks containing one or more
instruments.
The following settings are configured from the Bank Configuration screen:
• Instrument, Bank, and Lab names
• Bank Near Full Threshold (%)
• Incubation Temperature Set Point (°C)
• Waste Near Full Threshold (%)
• Maximum Allowable Time in Retrieval Area (min)
Figure 103: Bank Configuration Screen
1 Bank configuration screen tab

Naming Instruments System Configuration
Naming Instruments
From the Bank Configuration screen:
1. Select Instrument Name.
Figure 104: Naming Instruments
1 Instrument's location within the bank (where 1 is the

bank's A-unit and 2-4 are optional B-units from left
to right)
2 Instrument's name
2. Enter the Instrument Name.

3. Repeat steps 1 and 2 for each instrument.
4. Select Save.
Naming Banks and Labs

From the Bank Configuration screen:
1. Select Lab Name or Bank Name.
2. Enter the name.
IMPORTANT: Use only letters and/or numbers when naming banks. Do not use special
characters.
3. Select Save.
Configuring the Bank Near Full Threshold

Configure a percentage of the bank capacity to trigger an alert that indicates the remaining
bottle capacity within a bank is below an acceptable level.
Note: The default setting is 90%.
1. Select the Bank Near Full Threshold (%) display menu.

2. Select the desired capacity (%).
Note: The bank near full threshold capacity range is 75 to 95 in increments of 5.
3. Select Save.
Configuring the Incubation Temperature Set Point

Configure the desired temperature set point of all instruments in the bank. If the temperature
inside the instrument is out of range, too high or too low from the set point, a temperature
alarm appears. See Resolving Alarms and Alerts.

Configuring the Waste Near Full Threshold System Configuration
WARNING
Do not adjust incubation temperature if bottles are under test.
1. Select the Incubation Temperature Set Point (°C) display menu.

2. Select the desired temperature.
Note: The incubation temperature set point range is 30.0 to 40.0 in increments of 0.5. The
usual test range encountered in clinical laboratories is 35°C to 37°C.
3. Select Save.
Configuring the Waste Near Full Threshold

Configure an alert when the waste container reaches capacity. This alert indicates that the
remaining capacity in the waste container is below an acceptable level.
Note: The default setting is 75%. Available options are 50, 75, or 90% .
1. Select the Waste Near Full Threshold (%) display menu.

2. Select the appropriate waste container threshold.
3. Select Save.
Configuring the Maximum Allowable Time in Retrieval Area

Use the Maximum Allowable Time in Retrieval Area (min) to enter the amount of time (in
minutes) that the bottles can be left in the bottle return chutes in the bottle retrieval area. If
bottles are left in the bottle retrieval area longer than the configured time period, an alert
appears. Remove the bottles to resolve the alert. See Resolving Alarms and Alerts.
Note: The default setting is 15 minutes.
1. In the Maximum Allowable Time in Retrieval Area (min) field, select Display Menu.
Figure 105: Maximum Allowable Time in Retrieval Area (min) Field
2. Select the time period.

Configuring Sound Settings System Configuration
Note: The maximum allowable time in the retrieval area range is 15 to 60 in increments of
15.
3. Select Save.
Configuring Sound Settings

Configure the sound type, sound volume, and snooze feature from the Sound Configuration
screen.
Note: The Positive Bottle, Alarm, and Alert volumes can be turned off.
Figure 106: Sound Configuration Screen
1 Sound configuration tab

2 Save button
3 Volume on/off button
4 Volume up/down buttons
From the Sound Configuration screen:

1. Select Edit.
3. Select OK.
Configuring Sound and Volume

1. Select the Sound display menu.
2. Select the sound type.
• Sound 1- Default sound for a positive bottle, three pulses of the same frequency
• Sound 2- Default sound for alerts, a single pulse
• Sound 3- A multi-tone sound
• Sound 4- Default sound for alarms, three pulses of decreasing frequency

Configuring Snooze Time Period System Configuration
• Sound 5- A dog bark sound

3. To adjust the sound volume, select + or -.
Bars increase as volume increases.
4. To turn off an alert sound, select Volume Off.
5. Select Save.
WARNING
Use caution when disabling positive bottle alarms or instrument
alarms. Disabling the positive bottle alarm can lead to delayed results
if the positive bottle is not addressed. If these alarms are disabled and
a positive bottle or instrument malfunction occurs, then there will only
be a visual alarm. There will not be an audible alarm to indicate the
alarm condition.
Configuring Snooze Time Period

1. Select the Snooze display menu.
2. Select the snooze duration.
Note: The snooze range is 1 to 5 minutes in 1 minute increments and then 5 minute
increments up to 30 minutes.
3. Select Save.
Configuring Alarm Settings

Use the Alarm Configuration screen to set the color of the positive bottle alarm button and the
status indicator, set the maximum number of bottles allowed per accession, and enable or
disable the following alarms and alerts:
• Bank Near Full
• Bottle Data Changed
• Cell Calibration Failure
• Missing Accession ID
• Sample Volume Near Threshold
• Sample Volume Out of Range
• Waste Full
• Waste Near Full

Enabling and Disabling Alarms System Configuration
Figure 107: Alarm Configuration Screen
1 Alarm configuration tab
2 Save button
3 Checkbox enabled
4 Checkbox disabled
From the Alarm Configuration screen:

1. Select Edit.
3. Select OK.
Enabling and Disabling Alarms
WARNING
A potential hazard (false negative test result) exists if you disable an audible
alarm.

1. In the Enabled Alarms section, select an alarm.
2. Select Save.
Setting Positive Alarm Color

1. Select the positive alarm color.
Available positive colors:
• Red

Configuring Maximum Bottles Per Accession System Configuration
• Yellow
2. Select Save.
Configuring Maximum Bottles Per Accession

1. Select the Maximum Bottle Per Accession display menu.
2. Select the maximum bottles allowed per accession.
• Number 1 - 10
• No Limit
3. Select Save.
Configuring General Software Settings

The following General Software Configuration settings are available:
• Displaying patient data on the Bottle Details screen
• Using accession ID barcode on bottle
• Defining pattern for accession ID or patient ID barcode (if needed)
• Using alternate bottle ID (for example, using a bottle ID barcode other than a printed
bioMérieux barcode on the bottle)
• Using patient ID barcode on bottle (if configured)
• Measure Sample Volume
• Setting time format
• Configuring data retention and accession ID reuse (standalone configuration only)
• Remote notification and notification center (standalone configuration only)
• Archiving bottle data (includes archiving bottle images and graphs)
Figure 108: General Software Configuration Screen
1 General software configuration tab

Using Patient Data System Configuration
1. Select the General Software Configuration tab.

2. Select Edit.
4. Select OK.
Note: Depending on the system configuration, some configurations in General Software

Configuration may not be available.
Using Patient Data
Note: When this setting is enabled, patient data displays on the Bottle Status Information screen.
Additionally, in order to search by Patient ID in the Search screen, Use Patient Data must
be enabled.
From the General Software Configuration screen:

1. Select Use Patient Data.
2. Select Save.
Enabling Barcodes on Bottles and Defining Validation Patterns

1. Select the appropriate barcode labels to apply to the bottles. A maximum of two
barcodes may be selected.
• Accession ID barcode on bottle
WARNING
Failure to properly configure an accession ID can lead to delayed
results, which may be critical in some applications such as blood
bank.
• Alternate bottle ID barcode on bottle (Alternate bottle ID barcode uses the alternate
ID as the bottle ID in the system and for messages sent to the LIS.)
• Patient ID barcode on bottle
If more than one barcode on bottle setting is enabled (accession ID, alternate bottle
ID, or patient ID), define a validation pattern for either the accession ID or the patient
ID barcode.
2. Enter the validation pattern using regular expressions.
Table 12: Validation Patterns
The table provides definitions of regular expressions.
Expression Definition
\d Matches any digit
. Matches any character
* 0 or more of previous expression
+ 1 or more of previous expression
^ Start of string
$ End of string

Measuring Sample Volume System Configuration
Expression Definition
[] Explicit set of characters to match
[A-Z] any upper case letter
[a-z] any lower case letter
Table 13: Validation Pattern Examples
Description Patterns
Barcode starts with 3 upper case letters, ^[A-Z][A-Z][A-Z]\d\d.*
followed by 2 numbers, followed by any
characters
Barcode starts with any characters but *\d\d$
ends with two digits
Barcode always starts with the upper ACC\d+
case letters ACC followed by 1 or more
digits
Table 14: Valid and Invalid Validation Pattern Examples
Example Pattern Valid Match Invalid Match

[A-Z]\d\d B45 b2, B455
[A-Z a-z]\d any letter followed by a Z22
digit
g2|G2
Note: Multiple validation patterns are allowed. Use the pipe symbol (“|”) to separate multiple
patterns.
3. Select Save.
Measuring Sample Volume

1. Deselect Measure Sample Volume to disable the feature.
2. Select Save.
Setting the Time Format

1. Select the Time Format display menu.
2. Select either the 12 hour or 24 hour time format.
3. Select Save.
Configuring Data Retention and Accession ID Reuse
IMPORTANT: The following procedure for configuring data retention and accession ID reuse is for
instruments in standalone configuration only.

Configuring Remote Notification System Configuration
Note: This setting determines when accession IDs and associated bottle data are removed from
the system, thus allowing for reuse of the accession IDs.
From the General Software Configuration screen

1. Next to Data Retention/Accession Reuse (weeks), enter a value from 6 to 52
representing the number of weeks to retain data after the bottle is initially loaded.
2. Click Save.
Configuring Remote Notification

1. Select Remote Notification.
Note: Remote Notification must be enabled in order to access the Notification Center
Dashboard.
2. Select Save.
Accessing the Notification Center Dashboard

1. Click Notification Center.
The bioMérieux login page appears.
2. Enter the user name and password.
3. Click Login.
The Notification Dashboard appears.
Note: Refer to the Notification Center Software User Manual for more information.
Archiving Bottle Data
Note: The archive occurs daily once the Archive Bottles checkbox is selected.

1. Select the Archive Bottles display menu.
2. If desired, change the location to save the archive file.
Note: By default, the system saves the archive file to the F drive, but it can be configured to
save in another location.
3. If you wish to archive bottle graphs and images, select Archive Graphs and Images.
4. If you wish to encrypt the archive file, complete the following steps.
a) Select Encrypt Archive.
b) Enter a password.
Note: This password is used to view the archive file on another system. If you lose or
forget this password, you cannot view the archive file.
c) Re-enter the password to confirm.
d) Select Save.

Accessing the BCI Connect Dashboard System Configuration
Accessing the BCI Connect Dashboard

1. Click the BCI Connect button.
The bioMérieux login page appears.
3. Click Login.
The BCI Connect Dashboard appears.
Configuring Security Settings

Use the Security Configuration screen to configure:
• Enable 21CFR 11.
• Require a user request to unload bottles (positive, negative, or both).
• Require a login to unload bottles.
• Automatically log off after a period of inactivity.
Figure 109: Security Configuration Screen
1 Security configuration screen tab
2 21 CFR 11 field
From the Security Configuration screen:

1. Select Edit.
3. Select OK.
Enabling 21 CFR 11 Settings

1. Select 21 CFR 11 Enabled.

Disabling 21 CFR 11 Settings System Configuration
While 21 CFR 11 is enabled, you cannot change security configuration settings.
Figure 110: 21 CFR 11 Enabled Confirmation Message
2. Select OK.
Figure 111: 21 CFR 11 Settings
1 Blood culture bottle type 21 CFR 11 settings
Disabling 21 CFR 11 Settings

1. Deselect 21 CFR 11 Enabled.

Setting Inactivity Duration System Configuration
Figure 112: 21 CFR 11 Disabled Confirmation Message
2. Select OK.
3. Review settings and select the checkbox to enable or disable settings.
Figure 113: Security Settings Configuration Example
1 Blood culture bottle type security settings
4. To automatically unload bottles, complete one or more of the following steps.

• For positive bottles, deselect the User must request unload of positive bottles
checkbox.
• For negative bottles, deselect the User must request unload of negative bottles
checkbox.
5. If login is not required to unload bottles when selecting individual bottles to be
unloaded from the Search screen, uncheck the box Login required to unload
bottles.
6. Select Save.
Setting Inactivity Duration

Inactivity duration is the time period when no activity has been performed. The system
automatically logs the user out and returns to the Home screen when it reaches the
configured inactivity duration.
1. Select Edit.
2. Enter the duration time in minutes in Inactivity Duration (min).

Configuring LIS Settings (standalone configuration only) System Configuration
Note: The range is 5 to 30 minutes in 10 minute increments. The default inactivity duration
is 10 minutes.
3. Select Save.
Configuring LIS Settings (standalone configuration only)

The following LIS Configuration settings are available:
• Use a LIS
• Download test orders
• Upload bottle results
• Send consolidated messages to the LIS
• Automatically upload positive results
• Automatically upload negative results
• Send messages to the LIS upon loading bottles
• Send negative to date messages to the LIS
• Define LIS codes for bottle results
Figure 114: Configuration Screen
1 LIS configuration tab
1. Select the LIS Configuration tab

2. Click Edit.
3. Enter your user name and password,
4. Click OK.
Using a LIS
From the LIS Configuration screen:
1. Select the Use LIS checkbox.
2. Click Save.

Downloading Test Orders System Configuration
Downloading Test Orders

1. Select the Download Test Orders checkbox.
2. Click Save.
Uploading Bottle Results

1. Select the Upload Bottle Results checkbox,
2. Click Save.
Sending Consolidated Messages to the LIS
Note: When enabled, consolidated messages sent to the LIS include accession IDs and all
associated bottles.
1. Select the Use Consolidated LIS Messages checkbox.

2. Click Save.
Automatically Uploading Positive Results to the LIS

1. Select the Automatically Upload Positives checkbox.
2. Click Save.
Automatically Uploading Negatives Results to the LIS

1. Select the Automatically Upload Negatives checkbox.
2. Click Save.
Sending Negative to Date Messages to the LIS upon Loading Bottles

1. Select the Send Message on Bottle Load checkbox.
2. Select Save.
Sending Negative to Date Messages to the LIS

1. Select the Enable LIS Negative to Date Message Sending checkbox.
2. Enter a time interval in hours when you want to send a negative to date message to
the LIS,
For each loaded bottle, you can send a negative to date message once or at multiple
intervals:
• To send a message once, enter a single number and zero separated by a
semicolon. For example, entering 8;0 indicates that a message is sent 8 hours after
the bottle is loaded, but not a second time.

Defining LIS Codes for Bottle Results System Configuration
• To send a message at multiple intervals, enter multiple numbers separated by

semicolons. For example, entering 24;48;0 indicates that a message is sent 24
hours after the bottle is loaded, again after 48 hours, but not a third time.
• To send a message at a regular interval, enter a single number. For example,
entering 8 indicates that a message is sent every 8 hours after the bottle is loaded
until the bottle's status is no longer negative to date.
3. Click Save.
Defining LIS Codes for Bottle Results

1. Next to Positive, Negative, or Negative to Date Bottle Result Code, enter your
desired code.
2. Click Save.
Configuring Bottle Report Settings

IMPORTANT: The following procedures for configuring bottle report settings are for instruments in
standalone configuration only.
The following Bottle Report Configuration settings are available for each bottle report:
• Setting the date range
• Adding and removing columns
• Changing a column's position
• Sorting a column in ascending or descending order
Figure 115: Bottle Report Configuration Screen
1 Bottle report configuration tab
1. Select the Bottle Report Configuration tab.

2. From the Report drop-down menu, select the report you want to edit.

Setting Date Range System Configuration
3. Click Edit.
5. Click OK.
Note: Only one bottle report can be configured at a time.
Setting Date Range

From the Bottle Report Configuration screen:
1. From the Date Range drop-down menu, select the desired date range.
• None
• -24 = Last 24 hours
• T = Today
• T-1 - T-7 = Yesterday through 7 days ago
2. Click Save.
Adding Columns to a Report

1. In the Available list, click the column(s) you want to add to the report.
A minimum of 2 columns is required and a maximum of 10 columns is allowed per
report.
2. Click the right arrow to move the column(s) to the Selected list.
3. Click Save.
Removing Columns from a Report

1. In the Selected list, click the column(s) you want to remove from the report.
2. Click the left arrow to move the column(s) to the Available list.
3. Click Save.
Changing a Column's Position on a Report

1. In the Selected list, click the column(s) you want to reposition on the report.
2. Select the up or down arrow to change the position of the column(s).
If you move a column up on the Selected list, it will move to the left on the report.
3. Click Save.
Sorting a Column
1. From the Sort Column drop-down menu, select the column you want to sort on the
report.
2. Select the Ascending or Descending checkbox as your desired sort order.

Managing User Accounts and User Groups System Configuration
Managing User Accounts and User Groups
The User Management Users icon shows user identification data (first name, last name,
username), the groups to which the user belongs, and the status of the account (enabled,
locked, password expired).
The User Management Group icon shows the group name, application name, group
description, and group members.
The Lab Admin role sets up users initially and then can grant the permission to the Lab Super
role.
Accessing the User Management

1. Select User Management.
Figure 116: User Management
2. Log in to the User Management.
Password Policy
bioMérieux User Management applies a password policy which determines the rules for use
of passwords with the bioMérieux software. The policy includes three security levels:
• High security, in compliance with 21 CFR11, defined by the following rules:
◦ A password is valid for 3 months. The user receives a warning 2 weeks before his
password expires.
◦ The password must be at least 8 characters long and include at least one uppercase
letter and a digit (example: PasswØrd).
◦ The user’s last three passwords are saved for 1 year and cannot be reused during this
period of time.
◦ If the user enters an incorrect password 3 times, the session will not open.
◦ The user has to change his password at his first connection and after his account has
been unlocked.
• Medium security, in compliance with 21 CFR11, defined by the following rules:
◦ A password is valid for 6 months. The user receives a warning 2 weeks before his
password expires.
◦ The password must be at least 8 characters long (example: password).
◦ The user’s last three passwords are saved for 1 year and cannot be reused during this
period of time.
◦ If the user enters an incorrect password 10 times, the session will not open.
◦ The user has to change his password at his first connection and after his account has
been unlocked.
• Low security, no rules imposed.
This password policy cannot be modified from the three security levels described above.
The high level security policy is configured by default.
Defining User Identification Data

From the User Management Users tab:

Defining User Identification Data System Configuration
1. Select New User.
Note: The fields outlined in red are required.
Figure 117: Creating a New User Account
Table 15: User Management Icons

NEW USER Add new user data such as first name,
last name, email address, telephone
number, preferred language, and
assocated user group.
SAVE Save new or updated information.
CANCEL Cancel the previous action.
RESET Unlock a user account if the user has
exceeded the number of failed login
attempts permitted by the security policy
or if the user's password has expired.
DELETE Delete a user.
2. Enter the appropriate information in the corresponding fields for the user’s first name,
last name, username, email address, telephone number, preferred language, and
password.

Assigning User Rights System Configuration
Note: Do not use the following characters in the username:

• Backslash (\)
• Semi-colon (;)
• Comma (,)
• Plus (+)
• Space
Note: No security rules are imposed for password creation as the password is temporary
and must be modified at first connection to BACT/ALERT® VIRTUO®.
3. Select Save.
4. Select Yes to save all changes.
Note: Selecting No will discard all changes.
A confirmation message displays. The new account appears in the User list.
Assigning User Rights

From the User Management Groups tab:
1. Select the appropriate group. See User and Group Functions.
Note: User group names cannot be modified.
2. In Add User, select the new user account created.

3. Select Add to add the user to the group.
Figure 118: Add Icon
The user account is added to the list of group members.

4. Select Save.
A confirmation message displays.
Modifying User Identification Data

The following data can be modified: first name, last name, email address, telephone number,
preferred language, and associated user group.
Note: A username cannot be modified.

1. Select the user account to modify.
2. Modify the required identification fields.

Removing a User from a Group System Configuration
3. If necessary, select one:

• Assign the user to a new group.
1. Select the group.
2. Select Add.
• Delete the user from a group.

2. Select Delete.
4. Select Save.
The modifications are saved. A confirmation message displays.
Note: After editing a user, log out to allow changes to become effective.
Removing a User from a Group

From the User Management Groups tab:
2. Select the user to remove from the group.
3. Select Delete.
4. Select Save.
The user account is removed from the group. A confirmation message displays.
Disabling a User Account

1. Select the user account to disable.
2. Select the User Account is Disabled checkbox.
3. Select Save.

Re-enabling a User Account System Configuration
The user account is disabled. A confirmation message displays.
Note: A user account may be disabled without being deleted.
Re-enabling a User Account

1. Select the user account to re-enable.
2. Deselect the User account is disabled check box.
3. Select Save.
The user account is re-enabled. A confirmation message displays.
Unlocking a User Account

Change a user's password if the user cannot log in because they have exceeded the number
of failed login attempts permitted by the security policy or because their password has
expired.
1. From the User List, select the user account.
2. On the toolbar, click the Reset icon.
3. In the Password field, enter a new password.
4. In the Confirm password field, enter the password again.
IMPORTANT: Adhere to password security rules when changing passwords.
5. On the toolbar, click the Save icon.

The user account is unlocked. A confirmation message displays.
Note: The user must change this new password at the next login.

Deleting a User Account System Configuration
Deleting a User Account

IMPORTANT: It may be preferable to disable a user account, rather than to delete it, so that the user
login name cannot be reused by another person.

1. Select the user account to delete.
2. Select Delete.
A confirmation dialog box displays.
3. Select Yes.
The user account is deleted from the user list. A confirmation message displays.
Configuring Extenal Users in User Management

User Management provides the ability to allow external users to access bioMérieux local
applications. For example, Active Directory, LDAP, and Kerberos. It can also be used to add
external users to local groups in order to allow the user access to local applications.
IMPORTANT: There is no connection between User Management and an external Active Directory.
External users that are added to local groups may not exist in the external Active
Directory.
When external users are added to a local group, the user is not created in the local LDAP, but
is added as a member of the group.
Adding an External User to a Local Group

External users can be added to local groups from the Users screen or the Groups screen.
Adding External Users to a Local Group from Users Screen

From the User Management Users screen:
1. Enter an external user name in the External Users field.

Adding External User to Local Group from Groups Screen System Configuration
Figure 122: External Users
Note: The external user name is the same user name that is used to login.
2. Add groups to the external user. See Modifying User Identification Data.
Adding External User to Local Group from Groups Screen

From the Groups screen:
1. Select a group.
2. Enter the external username in the External Users field.
3. Select the Add icon.
4. Select Save.
Note: It is recommended to contact your local bioMérieux representative to connect to an

external Active Directory.
Note: Refer to the bioMérieux User Management User Manual for more information.
User and Group Functions

In User Management, each user is assigned to groups to allow certain privileges. The table
below explains which groups are available for each configuration.

User and Group Functions System Configuration
Note: A blank cell in the table below indicates the user group is not supported for that
configuration.
Table 16: User Groups Available for Each System Configuration
Group Standalone MYLA® MAESTRIA™

VIRTUO LabTech
VIRTUO LabSuper
Audit Trail User (ATUser)
Audit Trail Admin (ATAdmin)
BCI Connect User
BCI Connect Admin
User Management Admin

(UMAdmin)
Message Broker (MBAdmin)
BCI Link User
BCI Link Admin
MYLA Administrator
MYLA Manager
MYLA Tech
Notification Center User
Notification Center Admin
MAESTRIA Administrator
MAESTRIA Configuration
MAESTRIA Review

Group Standalone MYLA® MAESTRIA™

MAESTRIA Support
MAESTRIA Routine
User groups and their privileges:

• VIRTUO LabTech
◦ View configuration, but not edit.
◦ View and edit a bottle record.
◦ View reports.
◦ Resolve alarms, except expired bottle alarm.
• VIRTUO LabSuper
◦ View and edit configuration.
◦ View and edit a bottle record.
◦ View reports.
◦ Resolve all alarms, including expired bottle alarm.
• Audit Trail User (ATuser)
◦ Access to all areas of the audit trail software and can perform all functions except
configuring settings.
• Audit Trail Admin (ATadmin)
◦ Access to all areas of the audit trail software and can perform all functions.
• BCI Connect User
◦ Resolve BCI Connect alarms.
• BCI Connect Admin
◦ Configure BCI Connect.
• User Management Admin (UMadmin)
◦ Access to set up and manage user accounts.
• Message Broker (MBadmin)
◦ For bioMérieux use only. Users should not select this group.
• BCI Link User
◦ Resolve BCI Link alarms.
• BCI Link Admin
◦ Configure BCI Link.
• MYLA® (Refer to the MYLA® V4 or later User Manual for details.)
◦ Admin
◦ Manager
◦ Tech
• Notification Center (Refer to the Notification Center Software User Manual for details)
◦ User
◦ Admin
• MAESTRIA™ (Refer to the MAESTRIA™ User Manual for details)
◦ Administrator
◦ Configuration
◦ Review

◦ Support
◦ Routine
The following groups may be assigned to the LabTech role:
• VIRTUO LabTech
• Audit Trail User (ATuser)
• BCI Connect User
The following groups may be assigned to the LabSuper role:
• VIRTUO LabSuper
• Audit Trail Admin (ATadmin)
• BCI Connect Admin
• User Management Admin (UMadmin)

Emergency Manual Bottle Loading and
7 Unloading
To ensure that all manually loaded bottles are recognized by the instrument, keep a
handwritten log of all bottles loaded manually. Document the bottle IDs and cell locations.
Minimally, note the number of bottles loaded during each loading sequence. The Emergency
Manual Load Worksheet is an optional template to record bottles loaded and unloaded.
WARNING
In the Emergency Manual Bottle Loading procedure, if you reload a bottle that
was already in the system without scanning its barcode, the bottle is treated
as a new bottle. Data previously collected for that bottle is disregarded.
WARNING
A potential pinch hazard exists for mechanical parts during manual loading
and unloading of bottles.
Manually load and unload bottles if the following hardware failures occur:
• The conveyor belt is jammed or not functioning properly.
• The bottle indexer is jammed or not functioning properly.
• The robot is jammed or not functioning properly.
• The automatic scanner is not functioning properly and is causing anonymous bottles.
CAUTION: Do not manually load and unload bottles at the same time.
Manually load bottles and manually unload bottles as separate actions.
WARNING
The potential exists for bottle damage and leaking. Damaged and leaking
bottles may cause delayed or false positive test results.
Note: To minimize potential false positive determinations or subculture recommendations, follow

these temperature guidelines when opening the instrument door to perform the Emergency
Manual Load or Unload Procedures.
• Do not keep the instrument door open more than 10 minutes.
• If the door has been open less than 10 minutes, ensure the door is closed for a minimum
of 10 minutes before reopening the door.
• If the door has been open more than 10 minutes, the door should be closed as soon as
possible and remain closed for a minimum of 40 minutes before reopening the door.

Emergency Manual Bottle Loading and Unloading
Note: The best way to circumvent false positives after the door has been opened is to keep the
door closed for 3.5 hours before reopening. This ensures a stable temperature environment
after the door has been opened.
Table 17: Manual Load and Unload Elements

Manual Load Accesses the Manual Load screen.
Display Unavailable Displays the list of unavailable cells in the instrument.

Cells
Barcode Scanner Indicates the barcode scanner has been detected.

Detected
Barcode Scanner Not Indicates the handheld barcode scanner has not
Detected been detected.
Scan Barcode Scans the barcodes on the bottles to be loaded.
Manual Load Bottle Indicates the configured number of barcodes has

been recognized by the barcode scanner. Manually
loads the bottle associated with the listed barcodes.
Clear Barcodes Clears the displayed barcodes if the barcodes were

not successfully scanned or if more than the
acceptable number of barcodes were scanned.
Manual Unload Positive Manually unloads positive bottles during an

automation failure.
Manual Unload Manually unloads anonymous bottles during an

Anonymous automation failure.
Exit Exits the manual load, manual unload, or manual

unload positive mode and returns to the previous
screen.

Emergency Manual Unloading Positive Bottles Emergency Manual Bottle Loading and Unloading
Emergency Manual Unloading Positive Bottles
WARNING
Follow these steps to manually unload positive bottles. Failure to follow
these steps may cause clinical false negative results.
Note: Do not manually load bottles while in the Unload Positive mode.
WARNING
Step on the power supply cover plate when manually loading or unloading
bottles, if necessary to achieve more height. Do not step on a separate
device, as the consequence may be a crush hazard.
Note: The number of positive bottles to be unloaded appears prominently on the Home screen.
Note: If automated unloading is interrupted, do not unload final negative bottles. Keep these bottles
in the instrument until the automated unloading is repaired. If the automated unloading repair
is delayed and unloading negative bottles is necessary, contact bioMérieux support for
guidance on how to perform this task.
From the Small Display:

1. Select Information.
2. Select Manual Unload Positive.
A list of positive bottles appears with the following information:
• Bottle ID
• Cell location

Emergency Manual Unloading Positive Bottles Emergency Manual Bottle Loading and Unloading
Figure 124: Positive Bottles
Note: The bottles on the screen are color coded. Positive bottles are yellow or red
(depending on user configuration), negative to date bottles are blue, and negative
bottles are gray.
3. Open the instrument door.
CAUTION: Do not step on the bottom door hinge arm when the
instrument door is open as this may damage the instrument.
4. Manually remove the bottles listed.

5. Close the instrument door.
Note: Ensure no gap exists between the cabinet and the door.
A list of the bottles just unloaded or loaded appears.
Figure 125: Manually Loaded and Unloaded Bottles

Emergency Manual Loading Bottles Emergency Manual Bottle Loading and Unloading
Note: The bottles on the screen are color coded. Positive bottles are yellow or red
(depending on user configuration), negative to date bottles are blue, and negative
bottles are gray.
6. Verify the list on the screen with the actual bottles unloaded. Use the Emergency
Manual Load Worksheet as an optional template to manually record bottle information.
The number of positive bottles on the Home screen should be 0.
WARNING
To minimize temperature loss, limit the amount of time the instrument
door is open to once every two hours. Load bottles in batches so that
the door is not open more than 10 minutes. Shut the door when the
Door Open Too Long alarm sounds. The consequences of not
following these instructions may be false negative test results.
WARNING
Leaving the door open past the Door Open Too Long alarm may cause
missed readings and incorrect or no results and the need to
subculture bottles.
If a bottle still under test (negative to date status) is unloaded, a Negative to Date
Bottle Removed in Manual Loading alarm sounds. See Emergency Manual Loading
Bottles to reload this bottle.
7. Verify the actual bottles unloaded against the bottles listed on the Positive Bottles
Report. See Generating Bottle Reports in Site Configuration (MYLA).
8. Select Exit.
If the system is still alarming for positives because a positive bottle was not removed, then
repeat the process starting from step 1.
Emergency Manual Loading Bottles
WARNING
Follow these steps to enter and scan barcodes correctly. Failure to follow
these steps may cause clinical false negative results.
WARNING
Failure to account for loaded or unloaded bottles during manual loading may
lead to a consequence of no results or false negative results.
Note: To minimize temperature loss, limit the amount of time the instrument door is open. Load
bottles in batches so that the door is not open more than 10 minutes. Shut the door when the
Door Open Too Long alarm sounds.

WARNING
Leaving a bottle out of the system too long may lead to false negative
results.
WARNING
Step on the power supply cover plate when manually loading or unloading
bottles, if necessary to achieve more height. Do not step on a separate
CAUTION: Do not step on the bottom door hinge arm when the instrument
door is open as this may damage the instrument.
Note: Any bottle that is manually loaded because of disabled automatic loading will be
automatically rescanned after instrument automation is repaired.
CAUTION: Do not manually load and unload bottles at the same time.
Manually load bottles and manually unload bottles as separate actions.
WARNING
Subculture any bottle before reloading it manually. The consequences of not
subculturing a bottle before reloading it manually may be false negative
results.
WARNING
Subculture any bottle without a final result if the bottle will not be reloaded.
The consequences of not following this instruction may be no results.
Note: Do not unload bottles while in the Manual Load mode.
WARNING
Do not manually load a bottle into a cell from which you just manually
unloaded a bottle without scanning the bottle in accordance with Emergency
Manual Loading Bottles. This could result in erroneously creating a new
bottle record if the same bottle was unloaded and immediately reloaded; and
incorrect results may be a consequence.

WARNING
Allow the instrument to image manually loaded anonymous bottles rather
than resolving the anonymous bottles (unless the bottle goes positive before
automation is restored). The consequences of not following these
instructions may be false results.

2. Select Manual Load.
Note: Select Manual Load and scan the barcode before loading, or the loaded bottle will be
anonymous. See Emergency Manual Unloading Anonymous Bottles to resolve any
manually loaded anonymous bottles.
Figure 126: Manual Load Screen
3. Select Display Unavailable Cells.
Figure 127: Unavailable Cells List
Note: When manually loading bottles, avoid placing bottles into cells that are unavailable.
4. Retrieve the handheld barcode scanner from its intended storage location to the right
of the waste container inside the instrument.

6. Plug the handheld barcode scanner into the USB port on the back of the opened
instrument door.
Figure 128: Handheld Barcode Scanner

Figure 129: Barcode Scanner Port
The Barcode Scanner Detected icon appears on the Manual Load screen. If the
scanner is not detected, the Barcode Scanner Not Detected icon appears on the
Manual Load screen. Ensure the barcode scanner is plugged in properly.
Note: If the handheld barcode scanner is unresponsive or not detected then unplug and
reinsert the scanner into the barcode scanner port.

Figure 130: Barcode Scanner is Ready
Settings on the General Software Configuration screen determine the number of

barcode labels on the bottle and may include the bottle ID, an accession barcode, and
a patient barcode, for a maximum of three barcodes.
WARNING
Incorrectly entering and scanning barcodes to load bottles manually
may cause no results or false negative results.
7. Scan the bottle ID and other barcodes on the bottle in any sequence.
• The scanner beeps once for each barcode scanned and the green light on the
scanner blinks.
• The recognized barcode appears on the Manual Load Barcode screen if the
barcode is valid and is not a duplicate barcode.
• When the configured number of barcodes have been recognized, the scanner
beeps two more times, vibrates, and the green light on the scanner blinks.
• The Manual Load Bottle icon appears on the Small Display.
Figure 131: Manual Load Barcode screen

Note: If the barcodes were not successfully scanned or if more than the acceptable number
of barcodes were scanned, the scanner beeps seven times. Select Clear Barcodes
and rescan the barcodes to correct any scanning mistakes or to begin scanning a
new bottle.
Normally, blue and red LEDs illuminate throughout all empty cells in a continuous
motion. In the Manual Load mode, after the acceptable number of barcodes is
confirmed by the barcode scanner, the blue and red LEDs alternate between
illuminating all empty available cells in sequence or one suggested cell per rack.
8. Insert the bottle completely into the suggested cell, paying attention to the following:
• Place bottles into the cell with the bottle sensor inside the cell and the bottle top
outside the cell.
WARNING
Failure to properly orient the bottle when loading may lead to
incorrect results.
• Push the bottle all the way into the cell.

• Do not disturb any bottles already loaded.
WARNING
Do not touch or move other bottles previously loaded that do not
need to be moved; the consequences of not following these
instructions may be false positive results.
• Load the bottles as quickly as possible to minimize temperature loss.
WARNING
Incorrect results may be a consequence of incorrectly loading bottles,
or of not fully seating bottles when manually loading into cells.
9. Wait for the scanner to beep twice and vibrate to signify that the instrument recognizes
the bottle loaded. An attempt to scan another bottle before the previously scanned
bottle is recognized results in 7 beeps, the red light on the scanner flashing, and the
scanner vibrating.
The barcode scanner does not scan the next bottle until this bottle is recognized as
being loaded.
Note: The instrument does not detect a bottle that is loaded in an unavailable cell. If this
occurs, See Discrepancy in the Manually Loaded Bottle Count to resolve.
10. Repeat steps 7 to 8 to load each additional bottle.
Note: In order to avoid potential false positives, do not load bottles into the same rack or
into cells adjacent to previously loaded bottles during the same load event.
11. Remove the handheld barcode scanner from inside the instrument door when
scanning is complete.
An alarm sounds if the door is closed with the scanner still attached.
12. Replace the handheld barcode scanner in its intended storage location to the right of
the waste container inside the instrument.

Discrepancy in the Manually Loaded Bottle Count Emergency Manual Bottle Loading and Unloading
WARNING
Each bank has only one handheld barcode scanner. The
consequences of not replacing the handheld barcode scanner in its
intended location when scanning is complete may be no results.

14. Compare the Manually Loaded and Unloaded Bottle list on the Small Display to the
manual log.
15. Verify the actual bottles loaded against the bottles listed on the Loaded Bottles Report.
See Generating Bottle Reports in Site Configuration (MYLA).
16. Wait for the bottle counts on the Home screen to update.
If there is a discrepancy in the bottle count, see Discrepancy in the Manually Loaded
Bottle Count.
17. Select Exit on the Manually Loaded Bottle List screen in the Small Display.
Discrepancy in the Manually Loaded Bottle Count

If fewer bottles than expected appear on the Small Display:
1. From the Manual Load screen, tap the Display Unavailable Cells button to display
the list of unavailable cells.
3. Check unavailable cells for bottles.

4. Remove the bottles from the unavailable cells.
5. Load the bottles again. See Emergency Manual Loading Bottles.
6. Ensure that any bottle just loaded is fully inserted into the cell.
Anonymous Bottle Alert after Manual Loading
WARNING
The consequences of not correctly following these steps after the
anonymous bottle alert appears may be no results.
If the anonymous bottle alert appears on the Large Display after manual loading,
complete one of the following actions:
• If the bottle has been incubating for less than four hours and the bottle ID and cell
ID are recorded, unload the bottle. See Emergency Manual Unloading Anonymous
Bottles.
• If the bottle has been incubating for more than four hours and instrument repair is
expected soon, let the bottle continue to test as anonymous.
Note: Bottles will be rescanned after instrument repair is completed.

Emergency Manual Unloading Anonymous Bottles Emergency Manual Bottle Loading and Unloading
• If the bottle has been incubating for more than four hours and instrument repair is
not expected for some time, unload and then reload the bottle. See Emergency
Manual Unloading Anonymous Bottles and Emergency Manual Loading Bottles.
Emergency Manual Unloading Anonymous Bottles
If anonymous bottle records were created during the manual load procedure:
Note: Do not use this procedure to resolve any anonymous bottles that loaded automatically.
Note: The following procedure requires a handheld barcode scanner. If you reload an anonymous
bottle without scanning its barcode, it remains anonymous.
2. Select Manual Unload Anonymous.
A list of anonymous bottles appears showing the cell locations.
Note: These bottles are all anonymous; however, if they were just loaded they are all likely
negative to date (blue).
Figure 132: Anonymous Bottles
4. Remove the bottles from the cells listed, one bottle at a time. As you remove each
bottle, record the bottle ID, accession ID, and the cell location.

A list of the recently loaded and unloaded bottles appears on the Small Display.
6. Verify the list on the Small Display with the actual bottles unloaded and then select
Exit.
The Bottle Label Is Required message appears on the Large Display for the recently
unloaded anonymous bottles.
Figure 133: Bottle Label Is Required Message
IMPORTANT: Do not dismiss the message before identifying the anonymous bottles.
Dismissing the message will cause the bottle records to be lost, and the bottles
will need to be subcultured as a result.
7. On the Large Display, perform the following steps to identify the anonymous bottles.
a) Select the Edit Bottles Requiring a Label button.
b) Enter your user name and password if not already logged in.
c) On the Edit Bottle Record screen, enter the correct bottle ID based on the cell
location recorded in Step 4, save the change, and then enter the accession ID.

Figure 134: Edit Bottle Record Screen – Anonymous Bottle
Note: A bottle image is not available to obtain information from because the botttle was
loaded manually.
d) Save all changes.

e) Select the Dismiss Label Required Alarms button after entering bottle and
accession IDs for all anonymous bottles.
8. Follow the Emergency Manual Loading Bottles procedure to properly load the bottles.
After the bottles are loaded, the Bottle(s) Successfully Reloaded message appears on
the Large Display listing the bottles that were just reloaded.
Figure 135: Bottle(s) Successfully Reloaded Message
9. On the Large Display, select the Dismiss button.

Emergency Manual Load Worksheet Emergency Manual Bottle Loading and Unloading
Emergency Manual Load Worksheet
Use this worksheet as a template to manually record bottle information and confirm that all
manually loaded and unloaded bottles have been accounted for when you perform the
Emergency Manual Load procedure. Compare this list to the Manually Loaded and Unloaded
Bottles list on the Small Display.
WARNING
The consequences may be no results if all the bottles have not been
accounted for.
Accession ID Bottle ID Load Date/time Cell location

Emergency Manual Load Worksheet Emergency Manual Bottle Loading and Unloading
Accession ID Bottle ID Load Date/time Cell location

8 Troubleshooting
Resolving Alarms and Alerts
Any active alarms and alerts that are unresolved display in Zone 2 on the Home screen.
In addition, symbols may appear in the Severity column to indicate the severity of the alarm or
alert.
Viewing Alarms and Alerts

Select the appropriate alarm or alert icon in Zone 2.
All alarms and alerts that are active for the specific alarm category appear in the Bottle
Alerts List.
Figure 136: Example - Bottle Alerts List
Table 18: Bottle Alerts List
Column Description
Severity An orange triangle indicates an alert. This
does not prevent the system from
operating properly. A red circle indicates
an alarm. This problem must be resolved
immediately for the system to operate
properly.
Category Pictorial image indicates the category of
the alarm or alert: bottle, instrument,
communication, or PC
Type Text describes the specific alarm or alert.
Number The number of occurrences of the
specific alarm or alert.
Actions The means to resolve an alarm or alert.
Three buttons are available depending on
the alarm or alert.
Details Provides details about the alarm or alert
and the affected bottles. Select Bottle
Status Information to go directly to the
Bottle Status Information screen.

Alarm and Alert Causes and Resolutions Troubleshooting
Column Description
Dismiss Clears the alarm or alert from the screen.
Resolve Additional instructions about how to
resolve the alarm or alert appear. See
Alarm and Alert Causes and Resolutions.
Alarm and Alert Causes and Resolutions
WARNING
If you must open the door to resolve an alarm or alert, do not lean on the
conveyor belt. Leaning on the conveyor belt when the door is open (or any
other time as when the door is closed) may damage the door or the conveyor
belt and may result in a dropped bottle and no results.
CAUTION: Do not keep the door open for more than 10 minutes as that may
result in temperature loss and affect bottle test results.
Note: When the instrument door is open, follow the proper procedure. See Opening the Instrument
for Internal Access.
WARNING
Resolve all alarms immediately. The consequences of delays may be delayed
results.
WARNING
A potential hazard (delayed or false negative results) exists in the following
situations:
• System alarms are ignored or dismissed without corrective action.
• Corrective action and troubleshooting procedures are not correctly
followed.
Failure to act appropriately may result in a subculture recommendation.
Jams and Malfunctions

A jam is a recoverable temporary condition detected by the instrument. Usually this means
that a moving part did not arrive in the place it was expected to be. This doesn’t indicate that
something is physically wrong with the instrument, and is usually resolved by following the
instructions for the specific alarm in the Instrument Alarms and Alerts table. It is possible that
repeated jams are caused by an issue that needs to be corrected by bioMérieux.
A malfunction is a condition that likely requires maintenance by bioMérieux. It may mean that
a device such as the conveyor or robot is not communicating properly or is reporting a fault.

Follow the instructions for the specific alarm in the Instrument Alarms and Alerts table to help
resolve the issue.
Table 19: Bottle Alarms and Alerts
Alarm or Cause and Impact Resolution

Alert
Anonymous The bottle type and/or See Identifying an Anonymous Bottle without a Visible bioMérieux Label and Identifying
bottle found. bottle ID are missing from an Anonymous Bottle with a Visible bioMérieux Label to resolve the alert.
[3] the bottle record.
In Alternate Bottle Mode If the bioMérieux bottle ID is visible, unload the bottle and apply an alternate bottle ID
— Alternate Bottle ID label that matches the Alternate Bottle ID pattern configuration. See Applying a
label is missing from the Barcode Label to a Bottle.
bottle.
In Alternate Bottle Mode If the alternate bottle ID label is visible on the bottle image, unload the bottle and
— Alternate Bottle ID correctly apply the alternate bottle ID label to the bottle. See Applying a Barcode Label
label is incorrectly applied to a Bottle.
to the bottle.
In Alternate Bottle Mode Update the alternate bottle ID barcode configuration pattern to match the alternate
— Alternate Bottle ID bottle IDs being used. See Enabling Barcodes on Bottles and Defining Validation
label does not match the Patterns.
configured Alternate
Bottle ID pattern.
In Alternate Bottle Mode 1. On the PC, search for the bottle and view the image. A list of scanned barcodes
— Multiple bottle labels appears next to the image.
match the configured 2. View the scanned barcode list and determine if more than one barcode
Alternate Bottle ID matches the Alternate ID barcode pattern.
pattern.
3. If there is more than one barcode in the scanned barcode list that matches the
Alternate ID barcode pattern, update the alternate ID barcode configuration
pattern to be more specific to match the Alternate ID barcode label on the
bottle. See Enabling Barcodes on Bottles and Defining Validation Patterns.
In Alternate Bottle Mode Edit the bottle and assign a bottle type.
— No Bottle Type
assigned.
Bottle data One or more barcodes 1. View the Bottle Status Information screen for the changes.
changed on were changed on a bottle 2. If necessary, correct the bottle data, and possibly remove the bottle.
the listed before reload.
3. Select Dismiss.
bottle(s). [6]


Alert
® ®
A currently A bottle has been loaded A bottle is under test and the results are visible in BACT/ALERT VIRTUO .
expired bottle that has already reached
Note: Only a user with LabSuper access is authorized to process expired bottles. See
has been its expiration date.
Managing User Accounts and User Groups.
loaded. [8] Results may be
unreliable. Select one of the following options:
• Select Continue Test to release bottle results.

• Select Cancel Test to cancel testing and unload all bottles that are expired or
expiring.
WARNING
bioMérieux shall not be liable as to any defect (including, but not
limited to, incorrect results that may affect patient outcomes)
arising from the use of expired bottles, or the communication of
the results obtained using expired bottles. Users who use expired
bottles do so at their own risk.
Bottle(s) left A bottle has been left in Remove the bottle from the bottle retrieval area so that additional bottles can be
in the bottle the bottle retrieval area unloaded from the incubator.
retrieval area beyond the configured
beyond the time period.
configured
time period.
[9]
Bottle(s) A bottle was placed in a Testing is in progress.

placed in a cell with the incorrect
1. Select Unload.
cell with the agitation.
2. Unload the bottle and place it on the conveyor to reload.
incorrect
agitation. [11] Note: If needed, access the Bottle Status Information screen to view the bottle details.
The The barcodes scanned Unload the bottle and verify that the bottle ID does not exist for another bottle in the
barcode(s) on on the bottle matched database. If the bottle ID already exists in the database, it will be necessary to relabel
the listed one or more other bottle the bottle.
bottle(s) IDs.
match the
Bottle ID of
other bottle(s)
in the system.
[12]
Canceled A bottle test was 1. Reestablish the communication between the MCB and embedded PC.
bottle(s) could canceled during a loss of 2. Select Details to display the Alarm Details.
not be communication between
3. Select Search to display the Bottle Details.
unloaded the MCB and the
4. Select Unload to unload the bottle.
automatically. embedded PC.
5. If the problem persists, contact your local bioMérieux representative.
[14]


Alert
The Bottle ID The bottle ID for a 1. Access the Bottle Status Information screen for the bottle just loaded.
for a recently recently loaded bottle 2. Unload the bottle.
loaded bottle matches the bottle ID of a
3. Enter a new bottle ID.
matches the bottle previously known.
4. Apply a new label.
Bottle ID of a
5. Reload the bottle.
bottle
previously Note: If both bottles are available, use them to verify the correct bottle ID.
known to the
instrument. WARNING
[19]
Incorrect results may occur if a duplicate bottle alert is not
resolved.
WARNING
If it is determined that two bottles actually have the same bottle
ID, then contact your local bioMérieux representative to report the
issue.
A bottle was reloaded Unload the bottle. The alarm will resolve once the bottle is unloaded.
more than 10 days after it
was last unloaded. WARNING
If it is determined that two bottles actually have the same bottle
ID, then contact your local bioMérieux representative to report the
issue.
Negative A negative bottle was 1. Extend the maximum test time. See Changing the Maximum Test Time.
bottle(s) was reloaded.
reloaded. [32] Note: Do not wait more than 15 minutes to extend the maximum test
time. If automatic unloading is enabled, the bottle will unload to
the waste container after 15 minutes.
2. Dismiss the alert.
Note: If needed, access the Bottle Status Information screen to view the bottle details.


Alert
No accession No accession ID 1. Add the missing information on the Bottle Edit screen.
ID assigned assigned for the bottle. 2. Unload the bottle if it is necessary to apply an accession barcode.
for the bottle.
3. Apply a label to the bottle. See Applying a Barcode Label to a Bottle.
[33]
Multiple bottle barcode 1. On the PC, search for the bottle and view the image. A list of scanned barcodes
labels match the appears next to the image.
configured accession ID 2. View the scanned barcode list and determine if more than one barcode
pattern. matches the Accession ID barcode pattern.
3. If there is more than one barcode in the scanned barcode list that matches the
Accession ID barcode pattern, update the accession ID barcode configuration
pattern to be more specific to match the accession barcode label on the bottle.
See Enabling Barcodes on Bottles and Defining Validation Patterns.
Accession ID barcode Update the accession ID barcode configuration pattern to match the accessions being
label does not match the used. See Enabling Barcodes on Bottles and Defining Validation Patterns.
configured accession ID
pattern.
Accession ID barcode is Accession ID barcodes must be placed in a vertical position in order to be decoded by
not placed in the correct the imager.
orientation.
Positive A positive bottle was Complete one of the following steps:

bottle(s) have reloaded.
• Select OK to reload the bottle.
been
reloaded. [35]
CAUTION: The bottle status may change from positive to
negative to date and is flagged as an unconfirmed positive
bottle.
• Select Cancel. The bottle status remains positive. The bottle unloads.
Unmatched A bottle was manually 1. Record the cell ID of the bottle and unload the bottle.
reloaded reloaded without being 2. Perform a subculture, as the readings for the bottle are split across two different
bottle has scanned and therefore bottle records.
resulted in a anonymous. Upon
3. (Site configuration only) To remove the bottle from the Anonymous Bottle report:
duplicate rescan, the data is sent to
a. Locate the bottle on the report using the cell ID recorded in Step 1.
bottle record. the software and
[36] determines that there are b. Select the bottle and then click the Waste Can icon to delete the record.
now duplicate bottle

records in the system.
An anonymously loaded Contact your local bioMérieux representative for assistance.

bottle that was reimaged
resulted in a duplicate
bottle record for the same
bottle.
Sample Sample volume is out of Dismiss the alert. See Sample Volume Variation
volume is out configured range for the
of the listed bottle.
configured
range for the
listed
bottle(s). [43]


Alert
bioMérieux The subculture The Subculture Recommended Alarm is generated for bottles that have a gap of
recommends recommended alarm is readings of at least four hours. The algorithm may also generate the alarm after a gap
subculture of generated for bottles that of two hours, depending on the magnitude in the change of readings. bioMérieux
the bottle(s). have a gap of readings of recommends that the bottles are unloaded and subcultured.
[47] at least four hours. The
1. Unload the bottle.
algorithm may also
2. Subculture the bottle.
generate the alarm after a
gap of two hours,
depending on the
magnitude in the change WARNING
of readings. bioMérieux
Reloaded bottles must be subcultured. The consequences of
recommends that the
failing to subculture may be incorrect results.
bottles are unloaded and
subcultured.
The Alternate The alternate bottle ID for 1. Unload the bottle.

Bottle ID for a a recently loaded (data 2. Apply a new alternate bottle ID.
recently retention period) bottle
loaded bottle matches the alternate
matches the bottle ID of a bottle
Alternate previously known to the
WARNING
Bottle ID of a instrument.
Duplicating an alternate ID may lead to incorrect results.
bottle
previously
known to the
instrument.
[56]
Bottle(s) A bottle has been Complete one of the following steps:

reloaded reloaded with a non-
• If a non-bioMérieux bottle label was intentionally used, select Dismiss.
based on bioMérieux bottle label. • If a non-bioMérieux bottle label was unintentionally used, select Details to confirm
non- the bottle was properly labeled and unload the bottle if necessary.
bioMérieux
bottle label. WARNING
[57]
If a non-bioMérieux bottle label was changed before reloading,
then unload the bottle and subculture.
The number The number of non- A non-bioMérieux bottle has been loaded. bioMérieux cannot guarantee results
of non- bioMérieux bottles loaded obtained with non-bioMérieux bottles. Contact your local bioMérieux representative for
bioMérieux is approaching the assistance.
bottles loaded maximum allowed.
is
approaching
the maximum
allowed. [58]
A label needs A bottle ID barcode label 1. Relabel the bottle to match the entered bottle ID before reloading this bottle.
to be applied is required. 2. Label the bottle with a generic barcode.
to this bottle.
3. Contact your local bioMérieux representative for assistance.
[72]


Alert
Sample Sample volume is near See Sample Volume Variation.

volume is the upper or lower
near the threshold for the listed
upper or bottle.
lower
threshold for
the listed
bottle(s). [73]
Canceled Canceled bottle(s) was Remove the canceled bottle from the bottle retrieval area.
bottle(s) was reloaded. Canceled
reloaded. [74] bottle(s) cannot be
reloaded for testing.
Bottle(s) of an A bioMérieux bottle was 1. Unload the bottle from the bottle retrieval area.
unsupported loaded that is not 2. Dismiss the alert.
type will not supported by
® ®
3. Process the bottle manually.
be loaded. BACT/ALERT VIRTUO .
[75] The bottle will unload to
the bottle retrieval area.
There was a There was a conflict 1. Review the bottle record and the image with the listed scanned barcodes to
conflict between data from a determine which data values are correct.
between data scanned barcode and 2. Edit if necessary.
from a data in the bottle record.
scanned
barcode and
data in the
bottle record.
[76]
Accession ID An accession ID is 1. Search for the accession ID.

associated associated with more 2. Verify that associated patient IDs are correct.
with more than one patient ID.
than one
patient. [77]
A bottle with a A bottle with a duplicate Resolve the bottle ID duplication before reloading the bottle. Failure to resolve the
duplicate bottle ID of another duplication will result in merged records for these two bottles and potentially incorrect
bottle ID of loaded bottle was results.
another unloaded to the retrieval
loaded bottle area.
was unloaded
to the retrieval
area. [78]


Alert
Bottle unable The instrument was 1. Open the instrument door.

to be unable to unload a bottle 2. Remove the bottle or calibration standard from the listed cell.
removed from from a cell.
3. Visually inspect the cell for foreign debris.
cell. [83]
4. If the bottle must be reloaded:
• Examine the bottle for any unnecessary labeling that may have caused the
bottle to get stuck in the cell and remove if found.
• Close the instrument door.
• Place the bottle on the conveyor.
5. If the cell contained a calibration standard:
• Locate the other calibration standards in the instrument (the default

location is at the bottom right in rack P).
• Place the standard back in empty reserved cell. See Figure 102 for
placement.
• Close the instrument door.
A bottle was A bottle was found in the 1. Open the instrument door.
found in the robot gripper when the 2. Remove the bottle from the robot gripper.
gripper when instrument was started.
3. Place the gripper mechanism in a safe to move position, ensuring the gripper
the instrument
jaws are horizontal and do not extend beyond the end of the bracket.
was started.
[84]
5. Place the bottle on the conveyor to reload.
A negative to A negative to date bottle 1. Dismiss the alarm.

date bottle was removed in error 2. Reload the negative to date bottle. See Emergency Manual Loading Bottles
was removed while manually unloading
in error while positive bottles.
manually
unloading
positive
bottles. [86]
A bottle was A bottle was manually Unload the bottle. See Emergency Manual Unloading Positive Bottles or Emergency
manually loaded and determined to Manual Unloading Anonymous Bottles.
loaded and have an unsupported
determined to bottle type or to be a
have an duplicate.
unsupported
bottle type or
to be a
duplicate. [88]
A bottle was A bottle was manually 1. Verify that this bottle should be unloaded.
manually unloaded during the 2. Dismiss the alarm on the screen.
unloaded manual loading process.
3. If the bottle should not be unloaded, reload the bottle. See Emergency Manual
during the
Loading Bottles.
manual
loading
process. [89]


Alert
A bottle found A bottle found in an 1. Perform a subculture of the bottle if it has been more than four hours since the
in a non- unavailable cell was bottle has been manually loaded, or the load time is unknown.
operational unloaded to the bottle 2. Place the bottle in the loading area.
cell was retrieval area.
unloaded to
After closing the door 1. If it is a bottle, reload it.
the bottle
following a Bottle 2. If it is a calibration standard:
retrieval area.
Dropped Alarm [7], the
[90] • Open the door.
robot discovered an
• Place it back in its reserved location. Locate the other calibration standards
unseated bottle or in the instrument (the default location is at the bottom right in rack P), and
calibration standard in a place it back in empty reserved cell. See the Figure 102 for placement.
cell. 3. Close the door.
The The bioMérieux bottle ID 1. Compare the bottle ID on the image to the bottle ID on the record.
bioMérieux conflicts with the bottle ID 2. If the bottle IDs are different, unload the bottle and subculture. The bottle(s)
bottle ID manually scanned. This cannot be safely reloaded.
conflicts with indicates that bottle(s)
the bottle ID were not manually loaded
manually correctly and should be
scanned. [92] subcultured.
Duplicate The system has detected 1. Unload the duplicate bottle from the other instrument. The bottle cannot be
bottle was that bottles with duplicate loaded into the system until it has a unique bottle ID.
detected in bottle IDs have been 2. If unable to resolve, contact your local bioMérieux representative for assistance.
another loaded across different
instrument. instruments. A
[99] corresponding alarm "An
unexpected bottle has
been discovered and
unloaded by the
instrument.[97]" should
already exist on the
instrument that has the
first of the duplicate
bottles loaded.
A non- A non-bioMérieux bottle Contact your local bioMérieux representative for assistance.
bioMérieux has been loaded.
bottle has bioMérieux can not
been loaded. guarantee results
[102] obtained with non-
bioMérieux bottles.
Table 20: Instrument Alarms and Alerts

Alert
An agitation An agitation malfunction 1. Open the instrument door. See Opening the Instrument for Internal Access.
malfunction has occurred in the listed 2. Inspect the racks for problems that might inhibit movement. IF a problem is
has occurred instruments. Test results found, follow the robot jam recovery procedure. See Unjamming the Robot.
in the listed for bottles in the RDA
3. If no problem is found, close the door and wait about 15 minutes for the
instrument. [2] may be impacted.
instrument to initialize.
4. If a problem persists, contact your local bioMérieux representative.


Alert
Bank is almost Bank capacity has Dismiss the alert.

full. [4] reached the configured
Note: To change the threshold, see Configuring the Bank Near Full Threshold
threshold.
Bottle(s) on This takes into account 1. Ensure conveyor cover is on all B units and attempt to reload at the A unit.
the conveyor not only if the bank is full 2. Unload bottles with a final negative or positive status.
cannot be but also if all
3. Attempt to load bottles on each individual B unit. See Loading Bottles across a
loaded due to downstream instruments
Bank.
lack of bank are full. The upstream
4. Consider unloading the bottles nearing completion. See Unloading Specific
capacity or a may not be full.
Bottles by User Request.
malfunction/
jam. [5] Insufficient capacity to Bottles must be unloaded from the listed instrument or from any instrument to the right
load or transfer bottle in of the listed instrument. Consider unloading bottles nearing completion to add capacity.
listed instrument See Unloading Specific Bottles by User Request.
A malfunction or jam 1. Resolve the malfunction or jam.

alert displays on the 2. Load the bottle(s) into the affected instrument or into another instrument in the
instrument. The same bank.
instrument cannot load
bottles.
The instrument cannot 1. Open and close the blue flap to initialize the loader.
load bottles, even 2. Place the bottle(s) on the conveyor to load.
though capacity is
available and no other
alarm or alert displays.
Bottle(s) The bottle was not 1. At the Large Display, select Details from the alarm message to view the cell
dropped inside detected at its intended location. The cell location listed indicates the last known location of the bottle. If
the instrument. location and occrred the cell location is listed as P24, then the bottle dropped before it was loaded.
[7] during one of the 2. Open the instrument door.
following actions:
3. Inspect the following areas that may contain a bottle or calibration standard:
• Loading a bottle
• bottom of instrument
• Unloading a bottle
• robot gripper (bottle may be across from the gripper)
to the waste
container • retrieval chute
• Unloading a bottle • cell containing an unseated bottle or calibration standard
to the retrieval chute • waste chute
• Rescanning a bottle • rescan station
4. Inspect the listed cell location to determine if the bottle has been loaded.
Confirm the bottle is fully seated in the cell. If it is a bottle, then remove it from
the cell. If it is a calibration standard in cell P24 through P27, then push the
bottle further into the cell. If a calibration standard is found to be dropped inside
of the instrument, then place it back into the appropriate cell position: CAL 1 =
P24, CAL 2 = P25, CAL 3 = P26, CAL 4 = P27.
5. Close the door.
6. Reload the bottle on the conveyor.
WARNING
The consequences of not following instructions to resolve a bottle
dropped alarm may be no test results.
Note: If no bottle or calibration standard was found, then it is possible that it was placed
in a cell, but was not seated well enough to be detected by the instrument. After closing
the door, the robot will attempt to unload from the intended cell. If a bottle or calibration
standard is found by the robot, the Bottle Found In Unavailable Cell Alarm occurs and it
is returned to the retrieval area. If the dropped bottle is a calibration standard, see
Figure 102 for placement.


Alert
A bottle was A bottle has been placed 1. Access the Bottle Status Information screen to view the bottle details and
placed in a cell in a cell, but not fully determine the cell location.
that has seated. 2. Open the instrument door.
become non-
3. Remove the bottle from the cell.
operational.
[10]
5. Place the bottle on the conveyor to reload.
A cell has become non- 1. Access the Bottle Status Information screen to view the bottle details and
operational while a bottle determine the cell location.
is under test. 2. If a bottle unloaded to the return chute when the alarm occurred, reload the
bottle on the conveyor.
3. If the bottle details show the bottle as loaded, press the unload button. Reload
the bottle on the conveyor.
4. Subculture the bottle if a subculture alarm occurs after the reload.
5. If the alarm occurs again for the same cell, contact your local bioMérieux
representative.
Bottle(s) not Bottle(s) not properly 1. Select Unload.

properly seated in the cell and the 2. If the bottle(s) cannot be unloaded automatically, access the Bottle Status
seated in the instrument was not able Information screen to view the bottle details and determine the cell location.
cell and the to reposition.
3. Open the instrument door and remove the bottle(s) from the cell listed.
instrument
4. Place bottle(s) on the conveyor to reload.
was not able
to reposition.
[13]
Cell calibration Cell calibration failed Contact your local bioMérieux representative if multiple cells are out of service.
failed and the and the cell was
cell was removed from service.
removed from
service. [15]
One or more One or more of the 1. Open the instrument door.

of the calibration standards are 2. Ensure that the four calibration standards are located in the correct reserved
calibration missing or located in the cells. The default location for the calibration standards is rack P. The location of
standards is wrong reserved cells. the standards may change if there is a rack malfunction. CAL 1 must be in cell
missing or P24, CAL 2 must be in cell P25, CAL 3 must be in Cell P26, and CAL 4 must be
located in the in cell P27.
wrong
reserved cells.
[16]
Conveyor is The conveyor is not 1. Remove the indexer cover and retrieve bottles from the conveyor belt and
not functioning functioning properly. indexer.
properly. [17] 2. Inspect the conveyor belt for foreign objects or damage.
a. If no problem is evident, replace the indexer cover and place bottles on

conveyor to load.
b. If the problem persists, contact your local bioMérieux representative for
assistance.


Alert
Instrument Instrument door or door Close the door and allow the instrument temperature to equilibrate.
door open too latch cover has been
long. [18] open more than 2
WARNING
minutes.
Leaving the door open past the Door Open Too Long alarm may
cause missed readings and incorrect or no results and the need to
subculture bottles.
A message A message from the PC 1. Dismiss the alarm.

from the PC failed validation and was 2. If a bottle unloaded to the return chute when the alarm occurred, reload the
failed rejected by the bottle on the conveyor.
validation and instrument.
3. Subculture the bottle if a subculture alarm occurs after the bottle is reloaded.
was rejected
by the
instrument.
[20]
The Bottle The bottle imager is not Contact your local bioMérieux representative for assistance.
Imager is not functioning. Bottles
functioning. loaded automatically
[21] while the bottle imager is
not functioning are
loaded as anonymous
bottles. Do not reload
bottles while this alarm
displays.
The Bottle The bottle indexer is 1. Verify that all bottles are upright on the conveyor.
Indexer is jammed. 2. Remove the indexer cover.
jammed on the
3. Verify that no bottles are wedged between the conveyor and the indexer
listed
assembly.
instrument(s).
4. Replace the indexer cover.
[22]
5. Verify that the message clears.
6. If the problem persists, check the Robot Activity on the Small Display.
7. If Robot Activity is not on the screen, open and close the blue flap.
8. If the problem still persists, contact your local bioMérieux representative for
assistance.
WARNING
Using a damaged indexer cover may lead to delayed results or
physical injury.
The Bottle The bottle indexer is not 1. Verify that all bottles are upright on the conveyor.
Indexer is not functioning. 2. Remove the indexer cover.
functioning on
the listed
assembly.
instrument(s).
[23]


Alert
Power was Power was lost and the 1. Check the instrument power connections.
lost in the system was operating on 2. If the problem persists, contact your local bioMérieux representative for
listed UPS power. assistance.
instrument(s).
[37]
WARNING
A potential hazard (false negative results) exists if power is off for
longer than two hours.
Bottle retrieval The bottle retrieval area Remove bottles from the bottle retrieval area.
area is full for is full of bottles. Bottles
listed cannot be unloaded from
instrument(s). the instrument until
[39] bottles are removed from
the retrieval area.
A robot Robot calibration has 1. Open the instrument door. See Opening the Instrument for Internal Access.
calibration failed. 2. Follow the robot jam recovery procedure. See Unjamming the Robot.
failure has
occurred in the
WARNING
listed
instrument(s). The consequences of failing to assure proper rack re-
[40] installation may be delayed results.
3. Close the instrument door. See Opening the Instrument for Internal Access.
4. Wait about 15 minutes for the robot to recalibrate and the robot activity indicator
disappears from the small touchscreen.
5. If the problem persists, contact your local bioMérieux representative for
assistance.
A robot jam The robot is jammed. 1. Open the instrument door. See Opening the Instrument for Internal Access.
has occurred 2. Follow the robot jam recovery procedure, including a visual inspection of the
in the listed bottom of the instrument for fallen bottles. See Unjamming the Robot.
instrument(s).
[41]
4. If unable to resolve, contact your local bioMérieux representative.
A robot A robot malfunction has 1. Open the instrument door. See Opening the Instrument for Internal Access.
malfunction occurred. 2. Follow the robot jam recovery procedure. See Unjamming the Robot.
has occurred
in the listed
instrument(s).
[42]
Temperature is Instrument temperature 1. If the temperature is too low, ensure the door properly closes.
out of range is one degree outside of 2. Monitor the instrument temperature, allow to stabilize.
for the listed the instrument set point
3. If the temperature does not stabilize, contact bioMérieux Customer Service.
instrument(s). for more than 20
[48] minutes.
CAUTION: Loss of incubator temperature may adversely
affect bottle testing. Address immediately.
4. If the temperature is too high, verify the ambient temperature is within normal
operating range. See Environmental Characteristics.


Alert
The UPS The UPS battery is Contact your local bioMérieux representative for assistance.
battery is bad defective.
in the listed
instrument(s).
[50]
The UPS The UPS battery is low. Check that the UPS is properly plugged in to AC power. If the connections are correct,
battery is low and there is no power outage, contact your local bioMérieux representative for
in the listed assistance.
instrument(s).
[51]
WARNING
A potential hazard (false negative test result) exists if power is off
for longer than two hours.
Waste Waste container door is Replace the waste container or close the waste door.
container door open or the waste
If the problem persists,contact your local bioMérieux representative for assistance
is open or the container is missing.
waste Negative bottles cannot
container is unload to the waste
missing in the container.
listed
instrument(s).
[52]
Waste Waste container is full. Empty the waste container. See Emptying the Waste Container.
container is Negative bottles cannot
If the problem persists,contact your local bioMérieux representative for assistance.
full in unload to the waste
instrument(s). container until it is
[53] emptied.
Waste The waste container is Empty the waste container as soon as possible or negative bottles will not unload to the
container is nearly full. waste container. See Emptying the Waste Container and Configuring the Waste Near
near full in the Full Threshold.
listed
If the problem persists,contact your local bioMérieux representative for assistance.
instrument(s).
[54]
Problem with a A bottle has fallen on the 1. Set the bottle upright or remove the bottles from the loading area.
bottle(s) on conveyor. 2. Open and close the door flap if the alarm does not resolve.
the conveyor
of the listed
instrument(s).
[59]


Alert
A general A general hardware fault Contact your local bioMérieux representative for assistance.
hardware fault has occurred.
has occurred
WARNING
on the listed
instrument(s). A potential hazard (delayed or false negative results) exists in the
[60] following situations:
• System faults are ignored or overridden.

• Fault conditions reported by the instrument are not corrected
in a timely manner.
• System diagnosis and corrective action are delayed.
• Corrective action and troubleshooting procedures are not
correctly followed.
Failure to act appropriately may also lead to the need to

subculture the bottles.
The bottle The bottle retrieval area 1. Remove bottles from the bottle retrieval area.
retrieval area is jammed. 2. Open the instrument door and manually remove the bottles from the bottle
is jammed on return chute.
the listed
instrument(s).
[62]
An instrument An instrument rack fault 1. Manually unload bottles from the affected rack.
rack fault has has occurred on the 2. Place bottles on conveyor to reload.
occurred on listed instrument rack.
the listed
instrument
rack(s). [63]
WARNING
A potential hazard (delayed or false negative results) exists in the
following situations:
• System alarms are ignored or dismissed without corrective

action.
• Corrective action and troubleshooting procedures are not
correctly followed.
Failure to act appropriately may result in a subculture

recommendation.
The This alarm occurs when 1. Dismiss the alarm.

embedded the user reboots the 2. If the firmware reboots unexpectedly and the alarm occurs again, contact your
software has firmware using the Small local bioMérieux representative for assistance.
rebooted on Display or there is a
the listed power loss.
instrument(s).
Note: This alarm does
[65]
not occur when the user
reboots the internal PC
using the Large Display.


Alert
A spinner A spinner malfunction 1. Verify that all bottles are upright on the conveyor.
malfunction has occurred. 2. Remove the indexer cover.
has occurred
on the listed
assembly.
instrument(s).
[67]
assistance.
A spinner jam A spinner jam has 1. Verify that all bottles are upright on the conveyor.
has occurred occurred. 2. Remove the indexer cover.
on the listed
instrument(s).
assembly.
[68]
8. If the problem still persists, contact your local bioMérieux representative for
assistance.
The conveyor Conveyor belt jammed 1. Remove the indexer cover and retrieve bottles from the conveyor belt and
is jammed on when attempting to load indexer.
the listed bottles. 2. Inspect the conveyor belt for foreign objects or damage.
instrument(s).
a. If no problem is evident, replace the indexer cover and place bottles on
[69]
conveyor to load.
b. If the problem persists, contact your local bioMérieux representative for
assistance.
The The instrument transfer 1. Remove the indexer cover.

instrument mechanism inside the 2. Remove any obstruction and ensure that the bottle is upright, and replace the
transfer indexer cover has indexer cover.
mechanism malfunctioned.
3. If the bottle cannot be located, remove the conveyor cover of the instrument to
inside the
the right, remove any obstruction, and replace the conveyor cover.
indexer cover
has
malfunctioned.
assistance.
[70]
The The instrument transfer 1. Remove the indexer cover of the affected unit, checking the transfer arm.
instrument mechanism inside the 2. Remove any obstruction and ensure that the bottle is upright, and replace the
transfer indexer cover has indexer cover.
mechanism jammed.
3. If the bottle cannot be located, remove the conveyor cover of the unit to the
inside the
right, remove any obstruction, and replace the conveyor cover.
indexer cover
has jammed.
[71]


Alert
The ambient The ambient room 1. Ensure the ambient room temperature is within specifications (see
temperature is temperature is above the Environmental Characteristics).
above the recommended
recommended specifications.
WARNING
specifications.
[79] Bottle readings are not taken if the internal temperature is
outside specifications. The instrument stops taking
readings when the internal temperature is more than 1 C
from the setpoint for 20 minutes. The instrument begins
taking readings when the internal temperature is less that
0.5 C from setpoint for at least 30 minutes.
Bottle Internal temperature is 1. Ensure that the door is closed.

readings are out of range. Bottle 2. Ensure that the temperature is approaching the setpoint. If it is not, contact your
not being readings are not taken local bioMérieux representative for assistance.
taken because when the internal 3. If the condition continues for over four hours, then the bottles will need to be
the temperature is more subcultured, if indicated.
temperature than 1 degree from the
within the setpoint for at least 20
instrument is minutes. It begins taking
out of range. readings when the
[80] internal temperature is
0.5 degrees from the
setpoint for at least 30
minutes.
Update of The firmware update 1. Dismiss the alarm.

instrument failed. 2. Contact your local bioMérieux representative for assistance.
firmware has
failed. [81]
An excessive An excessive 1. Verify the instrument door is closed.

temperature temperature was 2. Contact your local bioMérieux representative for assistance.
gradient was detected across the
detected instrument.
across the
instrument.
[82]
The light The light source for the Contact your local bioMérieux representative.
source for the imager is not working.
imager is not
working. [85]
The handheld The handheld barcode 1. Open the instrument door.

scanner was scanner used for the 2. Disconnect and remove the handheld barcode scanner.
left inside the Emergency Manual
instrument. Loading Procedure was
[87] left inside the instrument.
The bottle The indexer cover is Replace or reseat the indexer cover.
indexer cover missing or not seated
is missing or properly.
WARNING
not seated
properly. [91] Failure to address an indexer not seated alarm may lead to
incorrect results.


Alert
The The instrument could not 1. Remove the conveyor cover of the unit that is affected.
instrument confirm that the bottle 2. Remove any obstruction and ensure the bottle is upright.
could not was successfully
3. If the bottle cannot be located, remove the indexer cover on the transferring
confirm that transferred to the next
instrument, remove any obstruction, and replace the cover.
the bottle was instrument.
4. If the issue is not resolved, contact your local bioMérieux representative for
successfully
assistance.
transferred to
the next
instrument.
[93]
The conveyor The conveyor cover is Replace the cover.

cover is missing.
missing. [94]
One of the One of the instruments Contact your local bioMérieux representative for assistance.
instruments in in the bank has been
the Bank has configured incorrectly.
been
configured
incorrectly.
[95]
The transfer The transfer gate is open 1. Remove the conveyor cover for the alarming instrument.
gate is open and must be closed to 2. Remove any obstruction and ensure the gate is closed.
and must be continue. See the
closed to Transfer Gate figure in
continue. [96] BACT/ALERT VIRTUO
Hardware.
An An unexpected bottle 1. Reload any bottles that were unloaded due to alarm 97 as soon as possible.
unexpected has been discovered 2. If the system has been restored with a System Image, contact your local
bottle has and unloaded by the bioMérieux representative for assistance
been instrument.
.
discovered
The instrument has
and unloaded
unloaded a bottle that it
by the
has determined that the
instrument.
PC software does not
[97]
have knowledge of. This
can happen as a result
of the PC being restored
with a System Image but
no data backup or a
duplicate bottle loaded
across instruments. The
SW thinks the duplicate
is a reload of the original
bottle.

Table 21: Software and Communication Alarms and Alerts

Alert
Communicati The internal PC has lost 1. Select Display Bank.

on has been communication with the 2. Check PC Status and Instrument Status. If the instrument status is
lost with the firmware of an instrument within Unknown, the instrument is disconnected. If the instrument status is
listed the same bank, or within a Resync, the instrument is connected and resynchronizing.
instrument(s). different bank if using Primary/
3. Check all network connections and the responsiveness of the small
[28] Secondary site configuration.
touchscreen.
The instrument cannot receive
4. When communication is re-established, data will be resynchronized.
data. While communication is
5. If the problem persists, reboot the system (see Rebooting the Instrument
lost, data present on the large
(Small Display)).
display may not be current.
Note: If the instrument is configured for user request unload mode and there is a
communication loss for more than 15 minutes, the instrument will automatically
unload any final positive bottles to the chutes and any negative bottles to the
waste container. When communication is reestablished, the instrument will revert
back to user request unload mode.
Communicati The internal PC has lost 1. Select Display Bank.

on has been communication with the 2. Check PC Status and Instrument Status. If the instrument status is
lost with the firmware of an instrument within Unknown, the instrument is disconnected. If the instrument status is
listed the same bank, or within a Resync, the instrument is connected and resynchronizing.
instrument(s). different bank if using Primary/
3. Check all network connections and the responsiveness of the small
[29] Secondary site configuration.
touchscreen.
The instrument is unable to
4. When communication is re-established, data will be resynchronized.
send data. While communication
5. If the problem persists, reboot the system (see Rebooting the Instrument
is lost, data present on the large
(Small Display) and Starting Up the Instrument).
display may not be current.
Note: If the instrument is configured for user request unload mode and there is a
communication loss for more than 15 minutes, the instrument will automatically
unload any final positive bottles to the chutes and any negative bottles to the
waste container. When communication is reestablished, the instrument will revert
back to user request unload mode.
® ®
MYLA A MYLA general software error Contact your local bioMérieux representative for assistance.
general occurred (site configuration
software only).
error. [30]
® ®
Communicati The MYLA service was 1. Wait 15 minutes for MYLA to fully initialize.
on has been recently restarted (site 2.
®
The alarm will automatically resolve itself once MYLA is fully started.
lost with configuration only).
®
3. If the alarm does not resolve, reboot the internal PC. See Rebooting the
MYLA . [31]
Internal PC (Large Display).
Purge old Purge old data has not recently 1. Perform a manual backup to trigger another purge. See Performing a
data has not completed successfully. Manual Data Backup.
recently 2. If the problem persists, contact your local bioMérieux representative for
completed assistance.
successfully.
[38] Note: The impact of not addressing the alarm can result in slow
PC performance, files growing too large, and backup
failures.


Alert
Scheduled Scheduled system backup 1. Select My Computer from the Start menu.
backup failed. failed. 2. Verify a USB device is installed on the PC and is mapped as drive F.
[44]
Note: If the system is configured for a network backup, verify
the network backup location is available.
3. If a backup location is not listed, contact your local bioMérieux

representative for assistance, if necessary.
4. Perform a manual backup. See Performing a Manual Data Backup.
assistance.
CAUTION: Do not attempt to physically access the backup

USB installed on the embedded PC. Contact your local
bioMérieux representative for assistance. Do not attempt to
access the backup USB installed on the embedded PC.
Network backup location is 1. Navigate to Start > Computer.

inaccessible (if using network 2. Locate the mapped drive for network backups.
backups).
3. Double click the drive and ensure it is accessible.
4. If the drive is accessible, dismiss the alarm and perform a manual
backup. See Performing a Manual Data Backup.
5. If the drive is inaccessible, contact your local bioMérieux representative
for assistance.
Messages A message from the instrument Contact your local bioMérieux representative for assistance.
failed failed validation and was
validation and rejected by the PC.
were
rejected. [45]
An An unexpected software error Contact your local bioMérieux representative for assistance.
unexpected has occurred.
software error
has occurred.
[46]
Time is out of The time on the PC was Contact your local bioMérieux representative for assistance.
synchronizati changed. This does not affect
on with the the test time of bottles under
PC in the test. It could affect the test time
listed of bottles reloaded after
instrument(s). changing the PC time.
[49]
An An unexpected software error 1. Contact your local bioMérieux representative for assistance.
unexpected occurred where the software 2. Dismiss the alarm.
database found a discrepancy in the
integrity error record.
has occurred.
An unexpected database Contact your local bioMérieux representative for assistance.
[55]
integrity error has occurred.


Alert
Firmware Firmware version is • If updating the system, finish updating all connected firmware and the alarm
should automatically resolve.
version is incompatible with software
• If the alarm is not resolved or no upgrade has taken place, collect all
incompatible version. The PC software has software and firmware logs and contact your local bioMérieux representative
with software detected that a connected for assistance.
version. [98] instrument is using an
incompatible version of
firmware. This can happen
during an upgrade, the software
is upgraded first and will throw
this alarm until all connected
firmware is upgraded.
A new A new knowledge base has Dismiss the alert.

Knowledge been imported to the instrument.
Base has
been
imported.
[100]
Unexpected An unexpected error occurred in 1. Open BCI CONNECT and review the error(s).
error the BCI CONNECT software. 2. Contact your local bioMérieux representative for assistance.
occurred in
BCI
CONNECT.
[103]
Archive Archive failed. Verify that the archive path is valid and writable.
failed. [104]
Communicati An unexpected error occurred in 1. Open the BCI CONNECT software and review the error(s).
on has been the BCI CONNECT software. 2. Contact your local bioMérieux representative for assistance.
lost with BCI
CONNECT.
[105]
A bottle has A bottle has been matched to a 1. Verify that the bottle has been matched to the correct test order using the
been potentially incorrect test order. accession number.
matched to a The test order may be outdated 2. If the test order is incorrect, unload the bottle and apply the appropriate
potentially or the bottle may have been accession barcode.
incorrect test loaded more than 30 days ago.
order. [106]
Bottle(s) were Bottle data could not be sent to 1. Navigate to the bottle record(s) and send the bottle data again.
unable to be the BCI CONNECT software. 2. If the problem persists, contact your local bioMérieux representative for
sent to BCI assistance.
CONNECT.
[107]
The A recently loaded or modified 1. Modify any incorrect associations.

maximum bottles allowed per Accession 2. Dismiss the alert.
number of ID .
bottles
allowed per
Accession ID
has been
exceeded.
[108]

Loading Bottles across a Bank Troubleshooting

Alert
™ ™
MAESTRIA A MAESTRIA general software Contact your local bioMérieux representative for assistance.
General error occurred (site configuration
Software only).
Error. [109]
™ ™ ™
MAESTRIA The MAESTRIA service was 1. Wait 15 minutes for MAESTRIA to full initialize.
loss of recently restarted (site ™
The alarm will automatically resolve itself once MAESTRIA is fully
communicatio configuration only).
started.
n. [110]
2. If the alarm does not resolve, reboot the internal PC. See Rebooting the
Internal PC (Large Display)
Notification A Notification Center software 1. Contact your local bioMérieux representative for assistnace.
Center error occurred (standalone 2. Dismiss the alarm.
Software configuration only).
Error [111]
Table 22: Unexpected Conditions
Condition Resolution
Unloading indicator does not Follow the instructions in Performing System Maintenance for shutting down the software.
resolve after bottles have
been unloaded.
Bottles do not load or unload 1. Remove the indexer cover, and inspect the bottle indexer and conveyor for obstructions.
as expected. 2. Install the indexer cover.
3. If step 1 does not work, follow the instructions for Unjamming the Robot.
Robot Activity stays on the 1. Remove the indexer cover, and inspect the bottle indexer and conveyor for obstructions.
Small Display more than three 2. Install the indexer cover.
minutes.
The conveyor belt does not 1. Remove the indexer cover, and inspect the bottle indexer and conveyor for obstructions.
start or stop. 2. Install the indexer cover.
The indexer wheel does not 1. Remove the indexer cover, and inspect the bottle indexer and conveyor for obstructions.
move. 2. Install the indexer cover.
Loading Bottles across a Bank

Loading bottles directly onto a B unit may be necessary if the transferring unit becomes non-
operational. To load bottles directly onto a B unit:
1. Remove the conveyor cover on the unit where bottles will be loaded.

Opening the Instrument for Internal Access Troubleshooting
Figure 137: Removing the Conveyor Cover
The conveyor cover is missing [94] alert will occur when the cover is removed. Dismiss
this from the large display of the A unit.
2. Load bottles directly onto the conveyor as you would for an A unit and ensure bottles
are moving to the Indexer.
Figure 138: Loading Bottles
3. Replace the conveyor cover when bottles have been successfully loaded.
WARNING
Not replacing the conveyor cover after loading bottles may cause
delayed results.
Opening the Instrument for Internal Access

Note: Instrument damage may result and patient test results may be lost or negatively affected if
the instrument door is not opened and closed properly.
Do not open the door, including the blue door handle cover above the conveyor, if the Robot
Activity indicator appears on the Small Display screen or when the Loading or Unloading
indicators appear on the Home screen. If the Robot Activity indicator remains on the Small
Display screen for 3 to 5 minutes, reboot the instrument. See Rebooting the Instrument
(Small Display).
WARNING
Opening the door when the Robot Activity icon appears on the Small Display
screen creates the potential of a crush hazard.

Opening the Instrument Door Troubleshooting
Note: The robotics and the agitation mechanism are disabled while the door is open.
WARNING
Step on the power supply cover plate when accessing the inside of the
instrument if necessary to achieve more height. Do not step on a separate
WARNING
Flashing lights are used inside the instrument, which may not be suitable for
photosensitive epilepsy.
Opening the Instrument Door
Note: To minimize potential false positive determinations or subculture recommendations, follow

these guidelines when opening the instrument door:
• If the door has been open less than 10 minutes, ensure the door is closed for a minimum
of 10 minutes before reopening the door.
• If the door has been open more than 10 minutes, the door should be closed as soon as
possible and remain closed for a minimum of 40 minutes before reopening the door.
Note: The best way to circumvent false positives after the door has been opened is to keep the
door closed for 3.5 hours before reopening. This ensures a stable temperature environment
after the door has been opened. A conservative bottle loading workflow after a door open
event would be to limit loading to less than 15 bottles every 10 minutes for the 3.5 hours after
the door is closed. After 3.5 hours, the user can return to their normal workflow. The open
door and batch loading guidelines above are intended to help reduce false positives after
instrument interventions. Due to the number of variables involved, each circumstance will be
different therefore false positive results and subculture recommendations should be
thoroughly evaluated.
To minimize the potential of a false positive or a subculture recommendation, do not open the
door, including the door latch above the conveyor, if the Robot Activity icon appears on the
Small Display screen or if the Loading or Unloading indicators appear on the Home screen.

1. From the Small Display, select Door Open Request.
Figure 139: Main Status Screen
1 Door Open Request Button
The Do Not Enter icon will appear on the main status screen while the robot returns to
its home position.
Figure 140: Do Not Enter Icon
1 Do Not Enter Icon

2. Verify the Do Not Enter icon changes to the Entry Allowed icon.

Figure 141: Entry Allowed Icon
1 Entry Allowed Icon
Note: If the Entry Allowed icon does not appear after 5 minutes, call bioMérieux customer
service.
3. If the instrument is a B unit, grasp the conveyor cover and gently push toward the
instrument, and then push upward to release the conveyor cover from the standoffs.
Figure 142: Conveyor Cover
1 Tabs
2 Conveyor Cover
3 Standoffs
4. Pull backward gently to release the conveyor cover from the tabs securing it to the
instrument.
5. On the grooved area on the door latch cover, press and release to open the door latch
cover.

Figure 143: Door Latch Cover
1 Grooved Area
6. Fold the door latch cover down to access the door latch.
7. Before opening a B unit, ensure that the transfer arm of the instrument to left is not
extended into the B unit.
Figure 144: Correct and Incorrect Transfer Arm Position
1 Correct position
2 Incorrect position
8. Grasp the door latch and swing it outward and to the right to the unlocked position.
IMPORTANT: The door latch is in the locked position when it is flush with the instrument. The
door latch is in the unlocked position when it is perpendicular to the
instrument. Do not pull on the instrument door when the door latch is in the
locked position.

Closing the Door Troubleshooting
Figure 145: Door Latch
1 Door Latch in Locked Position

2 Door Latch in Unlocked Position
9. Using the door latch, pull the door fully outward to gain access to the interior of the
instrument.
CAUTION: The door latch should be used to pull the door outward. Do
not use the sides of the instrument to pull the door of the instrument
forward. Failure to comply may result in damage to the exterior surface
of the instrument.
Closing the Door
WARNING
Instrument damage may result and patient test results may be lost or
negatively affected if the instrument door is not opened and closed properly.
Note: The safe to move sensor is not available on all instruments.
WARNING
Failure to place the robot gripper in the safe to move position prevents robot
automation, which could delay results. For information on the safe to move
sensor, see BACT/ALERT VIRTUO Hardware.

1. Place the gripper mechanism in the safe to move position, ensuring the gripper jaws
are horizontal and do not extend beyond the end of the bracket.
2. Using the door latch, swing the door inward to position the door directly in front of the
instrument.
CAUTION: The door latch should be used to swing the door inward. Do
not use the sides of the instrument to push the door of the instrument
forward. Failure to comply may result in damage to the exterior surface
of the instrument.
3. Gently push the door forward to the fully closed position.
WARNING
If the door is not fully secured, the consequences may be delayed
results.
Note: Once the door is squared with the chassis, it is acceptable to push on the top sides of
the instrument to close the door. Do not push on the large display screen or small
display screen when moving the door to the closed position. Failure to comply may
result in damage to the exterior surface of the instrument.
The kickstand will raise and stow inside the door when the door is pushed forward to
the fully closed position.
4. Ensure the door is fully aligned against the instrument.
5. While pushing firmly on the top of the instrument above the Bank Display, grasp the
door latch and push it flush against the instrument to the locked position.
Note: The door latch is in the locked position when it is flush with the instrument. The door
latch is in the unlocked position when it is perpendicular to the instrument. Do not pull
on the instrument door when the door latch is in the locked position.
Figure 146: Door Latch
1 Door Latch in Locked Position

2 Door Latch in Unlocked Position

6. Position the door latch cover flush against the instrument and press on the grooved
area to secure the door latch cover.
Figure 147: Door Latch Cover
1 Grooved Area
7. Address any alarms or messages related to the retrieved bottles.
Note: If the alarm persists after two attempts, contact your local bioMérieux representative
for assistance.
8. Attempt this recovery a second time if the alarm remains after completing all of the
steps.
9. Replace the conveyor cover.

Unjamming the Robot Troubleshooting
10. Ensure the red dot from the conveyor cover sensor is visible on the right tab.
Figure 148: Conveyor Cover Sensor Red Dot
11. If the red dot from the conveyor cover sensor is not visible, reposition the conveyor
cover until the red dot is visible.
Unjamming the Robot

Note: Any bottle found in the instrument and placed again on the conveyor will be processed by the
instrument.
The robotics and the agitation mechanism are disabled while the door is open.
WARNING
When the instrument door is open, take care of the critical laser component
required for robotic alignment. Do not grasp, pull on, or impact the laser. Do
not touch the laser optics window.
1. See Opening the Instrument Door to open the instrument door.

2. Locate the robot gripper arm and inspect for the presence of a bottle or a calibration
standard. If present, remove the bottle or calibration standard from the robot gripper.

Figure 149: Remove Bottle
3. Pull the gripper and the bottle away from the cell.
Figure 150: Pull Gripper
4. Gently move the bottle from side to side to ease it out of the gripper.
Figure 151: Move Bottle
5. If the bottle is partially in a cell.

• Pull the bottle and gripper mechanism toward you to dislodge the bottle from the
cell.
• Hold the bottle and gripper jaws as you pull.
• Press on the top or bottom of the rack, rotate the rack up or down so that the
bottles are horizontal to make the jammed bottle easier to remove.
6. Grasp the end of the bottle and gently move the bottle up and down until it comes out
of the gripper.
Note: A bottle should not be in the gripper when the door is closed.
7. If any bottles or calibration standards are on the floor of the instrument, remove them.
8. Move the robot to the left and then to the right to look for bottles on both sides.
9. Place bottles on the loading station conveyor belt to be processed by the system.
10. Verify that four calibration standards are present in their reserved cells. CAL 1 must be
in cell P24, CAL 2 must be in cell P25, CAL 3 must be in cell P26, and CAL 4 must be
in cell P27.
Note: Calibration standards must always be located in cells P24, P25, P26, and P27.

Figure 152: Calibration Standards
1 CAL1
2 CAL2
3 CAL3
4 CAL4
11. Find missing calibration standards located elsewhere in the incubator and move them
to correct cells.
12. Place the gripper mechanism in its safe to move position, ensuring the gripper jaws
are horizontal and do not extend beyond the end of the bracket.
Figure 153: Park the Gripper
13. Check that the green LED turns on when in the proper position.

Audit Trail Troubleshooting
Figure 154: Safe to Move Sensor
1 Safe To Move Sensor
2 Safe To Move LED
3 Gripper Assembly
14. To close the instrument door, see Closing the Door.
Audit Trail
The Audit Trail contains auditable actions that affect bottle test results such as user
modifications to records and system configuration.
Access system status information while a bottle is under test.
Accessing the Audit Trail

1. Select Audit Trail.
Figure 155: Audit Trail Icon
2. Log in to the Audit Trail.

Audit Trail for Standalone and Site Configuration (MAESTRIA™) Troubleshooting
Audit Trail for Standalone and Site Configuration (MAESTRIA™)
Audit Trail Screen
Figure 156: Audit Trail Screen for Standalone and Site Configuration (MAESTRIA™)
Table 23: Audit Trail Screen Icons

Records Lists the audit trail records.
Archiving Define settings for automatic and manual archiving.
Menu Access the audit trail about screen and sign out.
Refresh Refreshes the audit trail record list. If new data is

available, but not displayed, a number will appear above
the Refresh button. The list will update when the Refresh
button is clicked.
Note: If the Refresh button is greyed out, it cannot be
selected.
Delete Delete one or more rejected messages in the record list.

Rejected
Note: Rejected records are highlighted in red.
Message
Note: Only users with Audit Trail Support rights can
perform this action.
Note: By default, the icon is greyed out and unavailable
unless a rejected record is selected.

Audit Trail Filter Settings Troubleshooting

Export Access the audit trail export settings.
Filter Access the audit trail filter settings.
Audit Trail Filter Settings
Table 24: Audit Trail Filter Settings
Filter Description
Date Range (Start Date - End Date) Select a date range for which to display Audit
Trail records.
Record State Select a record state for which to display
Audit Trail records.
Data Content Type Select a data content type for which to
display Audit Trail records.
User Select a user for which to display Audit Trail
records.
System Select a system name for which to display
Audit Trail records.
Action Select an action for which to display Audit
Trail records.
The available events can include:
• Auto logoff
• Create
• Delete
• Login
• Logout
• Update
Item Select an audit type for which to display

Audit Trail records. The available audit types
depend on the connected systems and
instruments, and may include alarms or
bottles.
Item Id Enter text to search for available Item Id.
Details Enter text to search for available details.

Audit Trail Records Troubleshooting
Audit Trail Records
Table 25: Audit Trail Records
Record Detail Description

Column Header Select a column header to sort the records
according to column value (by date,
alphabet, or number).
Down Arrow Select to sort the records in deescending
order (by date, alphabet, or number).
Up Arrow Select to sort the records in ascending order
(by date, alphabet, or number).
Record State Record state of the Audit Trail record.
Date Creation date and time of the Audit Trail
record.
User User related with Audit Trail record.
System System of the Audit Trail record.
Item Item of the Audit Trail record.
Item Id Item ID of the Audit Trail record.
Action Action of the Audit Trail record.
Record Details
Highlight a record on the Audit Trail screen. The record appears in the Record Details screen.
Figure 157: Record Details
Table 26: Record Details

Action Action for the Audit Trail record.
User User for the Audit Trail record.
System System for the Audit Trail record.
Item Item for the Audit Trail record.
Detail Audit details for the Audit Trail record, such
as bottle status.

Exporting Audit Trail Reports and Saving to an External Device Troubleshooting

Left Arrow Select to access the previous Audit Trail
record.
Right Arrow Select to access the next Audit Trail record.
Exporting Audit Trail Reports and Saving to an External Device

From the Audit Trail screen
1. Search for the desired data and select Export.
Note: Select the All radio button to select all of the displayed Audit Trail records for export.
2. Select the desired file format.

3. Optional: Select the With details checkbox to include details.
4. Enter a password that is at least 12 characters.
5. Select Export.
6. Select the external device to save the file (USB device or network drive).
7. Select Save.
The exported file is saved to the selected location.
Audit Trail for Site Configuration (MYLA®)
Audit Trail Screen
Figure 158: Audit Trail Screen for Site Configuration (MYLA®)
1 Filter area
2 Audit trail record area

Audit Trail Filter Settings Troubleshooting
Table 27: Audit Trail Screen Icons

Home Return to the Audit Trail Home screen.
Export Start the export of the Audit Trail records according

to the export settings.
Settings Define the export and archive file formats of Audit

Trail data, the retention period for archive files, and
the number of records per Audit Trail report page in
PDF.
Help Access the Audit Trail User Manual for help.
Logout Log out.
Audit Trail Filter Settings
Table 28: Audit Trail Filter Settings
Filter Description
Date range (from - to) Select a date range for which to display Audit Trail records.
Event type Select an event for which to display Audit Trail records.
The available events may include auto logoff, create, delete,
login, logout, or update.
Audit type Select an audit type for which to display Audit Trail records.
The available audit types depend on the connected systems
and instruments and may include alarm or bottle.
System name Select a system name type for which to display Audit Trail
records.
Identifier Enter text to search for available identifiers.
Expand to display or collapse to hide further search criteria
for the display of Audit Trail records.
Advanced Criteria
Record type Select a record type for which to display Audit Trail records.
Available record types are:
• Auditchange - electronic data change that must be
audited for 21CFR11 compliance.
• Auditinformation - Additional information of an audit entry
for support and investigation purposes.
• Auditlogin - Login audit entry.
Audit hierarchy Select an audit hierarchy type for which to display Audit Trail
records.
System ID Select a system ID for which to display Audit Trail records.

Audit Trail Records Troubleshooting
Filter Description
Audit hierarchy ID Enter text to search for available audit hierarchy IDs.
User ID Enter text to search available user IDs.
Audit details Enter text to search available audit details.
Search Select to display Audit Trail records according to the filter
settings.
Clear Filter Select to reset all filter settings.
Audit Trail Records
Table 29: Audit Trail Records

1-10 of 3938 (example) The first ten records out of 3928 in total display.
Select to display the next ten records.
Select to display the last page of records.
Select to display the previous ten records.
Select to display the first page of records.
Column header Select a column header to sort the records according to the
column value (by date, alphabet, or number).
Select to sort the records in descending order (by date,
Select to sort the records in ascending order (by date,
Date Creation date and time of the Audit Trail record.
Record type Record type of the Audit Trail record.
Event type type Event type for the Audit Trail record.
System name System name for the Audit Trail record.
Audit type Audit type of the Audit Trail record.
Audit ID Audit ID of the Audit Trail record.
Audit hierarchy Audit hierarchy of the Audit Trail record.
Audit hierarchy ID Audit hierarchy ID of the Audit Trail record.
User ID User ID related with the Audit Trail record.
Select to open the Hierarchical View menu for the record.
Select to open the Show Record details.
Record Details
Highlight a record on the Audit Trail screen. The record appears in the Record Details section.

Exporting Audit Trail Reports and Saving to an External Device Troubleshooting
Figure 159: Record Details
Table 30: Record Details

System ID System ID for the Audit Trail record.
System type System type for the Audit Trail record.
System version System version for the Audit Trail record.
Audit details Audit details for the Audit Trail record such as bottle status.
Comments User comments for the Audit Trail record.
Switch to English values Select to display the content of the audit details field in
English format. The button text changes to "Switch to user-
language values."
Switch to user-language Select to display the content of the audit details field in the
values current user language selected during software login. The
button text changes to "Switch to English values."
Exporting Audit Trail Reports and Saving to an External Device

From the Audit Trail Search screen:
1. Search for desired data and select Export
2. Select Save File.
3. Select OK.
4. Select the external device to save the file (USB device, network drive).
5. Select Save.
This saves the exported file to this location.
Viewing/Printing Saved Audit on an External PC
1. Access the external device (USB device, network drive) and open the exported file in a
program such as Excel (.csv) or Adobe Acrobat (.pdf).
2. To print, use the print function provided by the appropriate program
Note: Refer to the bioMérieux User Management User Manual applicable to the system
configuration.

Collect Logs Troubleshooting
Collect Logs
The BACT/ALERT® VIRTUO® logs can be collected and provided to bioMérieux support for
issue investigation.
Generating the Log File

A LabAdmin user must be logged in to the PC in order to access the Collect Virtuo Logs
feature.
From the Desktop:
1. Double-click on the Collect Virtuo Logs shortcut. Select Yes on the User Account
Control dialog.
Figure 160: Collect Virtuo Logs Shortcut
Figure 161: User Account Control dialog
The Collect MCB Logs dialog box displays.
Figure 162: Collect MCB Logs
2. Select one of the following:

• Select Yes to collect the MCB Logs.
• Select No to not collect the MCB Logs.
Selecting Yes or No will prompt the command to continue to run. The Collect Bottle
Images dialog box displays.

Generating the Log File Troubleshooting
Figure 163: Collect Bottle Images
3. Select one of the following:

• Select Yes to collect the bottle images.
• Select No to not collect the bottle images.
Selecting Yes or No will prompt the command to continue to run. The enter password
dialog box displays.
Figure 164: Enter Password
Note: The collected logs may contain patient data, so a password may be entered in order
to encrypt the log files. If an encryption password is entered, then the password must
be provided to bioMérieux support so that the log files can be accessed.
4. If the log files needs to be encrypted, enter a password and select OK.
If the log files do not need to be encrypted, do not enter a password and select
Cancel.
The command will continue to run for several minutes. Do not close the command
screen. When the log collection is complete, a dialog box displays indicating the file is
on the Desktop.
Figure 165: File Name
5. Select OK.
The command screen closes. The VIRTUO_logs_YYYYMMDDHHMMSS.zip folder is
on the Desktop and can be copied to a USB to be used by bioMérieux support. If an
encryption password was entered in the previous step, provide the password to
bioMérieux support.

Notification Center (Standalone Configuration only) Troubleshooting
Figure 166: Log Folder
Notification Center (Standalone Configuration only)
The system can notify the user through email when positive bottles or alarms occur on the
system.
Remote Notification must be enabled in General Software Configuration in order to access
the Notification Center.
Figure 167: General Software Configuration - Remote Notification Enabled
The following events are available for the BACT/ALERT® VIRTUO® system:
Table 31: BACT/ALERT® VIRTUO® Notification Events
Event Notification Frequency Description

Positive Bottle This event occurs when a Used to send an email based
bottle result changes to on a newly detected positive
positive. bottle.
Alarm This event occurs when there Used to send an email based
is a new alarm. on a new alarm.

Configuring the Notification Center for BACT/ALERT® VIRTUO®
Events Troubleshooting
Configuring the Notification Center for BACT/ALERT® VIRTUO® Events

It is recommended to contact a bioMérieux representative to configure the notification rules.
Once the rules are configured, the user can modify the rules, if needed.
Refer to the Notification Center Software User Manual for more information on how to
configure the notification rules.
1. Log in to the Notification Center.
The RULES page displays.
Figure 168: Notification Center Rules Home Screen
2. Select Add an Element.
Figure 169: Add an Element
The Initialisation (STEP 1) screen displays.

Figure 170: Step 1 - Initialisation
1 Create a new notification strategy pane

2 Summary pane
3. Enter the Strategy Name (required).

4. Optional: Enter a Description.
5. Select VIRTUO from the Appication display menu.
6. Select an event from the Event display menu.
• Positive Bottle Event
• Alarm Event
The events are listed in the Notification Center.
7. Select STEP 2.
The Criteria page displays.
Figure 171: Step 2 - Criteria
8. Select a criteria from the Criterion name display menu.

Figure 172: Notification Rule Definition
1 Conjunction
2 Criterion name
3 Operator
4 Value
5 Delete
Event Criteria
Positive Bottle The criteria corresponds to the
information available for the positive
bottle.
• System: Corresponds to the system
currently incubating the bottle
• Bank Name
• Bottle ID
• Accession ID: Corresponds to the Lab
ID
• Instrument Name
• Instrument Serial Number
• Sample Type
• Bottle Result Date
• Generated Date and Time
• Bottle Type
• Time to Detection: Corresponds to the
duraction between load date and time
and positive date and time
• Load Date and Time
Alarm The criteria corresponds to the

information available for the alarm.
• System: Corresponds to the system
currently incubating the bottle.
• Alarm Number
• Severity
• Alarm Name
• Generated Date and Time
• Alarm Creation Date and Time
• Instrument Name
• Instrument Serial Number
9. Select the Operator.

• = (is equal to)
• != (is not equal to)

• Contains
• Does not contain
10. Enter the Value associated to the criteria.
11. Select APPLY CRITERIA to save the criteria.
The applied criteria displays in the Summary pane.
The figure below is an example of a Positive Bottle event, where an email is sent each
time a bottle becomes positive that is incubating in a System named VIRTUO or if the
bottle is incubating in a bank with a Bank Name that contains the word Bank.
Figure 173: Example of Positive Bottle Event
The figure below is an example of an Alarm Event, where an email is sent each time a
new alarm is generated on an instrument that is named INSTRUMENT1 or
INSTRUMENT2.
Figure 174: Example of Alarm Event
12. Optional: Add additional criteria that are separated by the conjuctions OR or AND.
Note: Select the Delete icon to remove a criterion.
13. Select STEP 3.

BACT/ALERT® VIRTUO® does not support sending notifications to the light tower in
standalone configuration so this step is skipped.
14. Select STEP 4.
The Action Mailing List page displays.
Figure 175: Step 4 - Action Mailing List
15. Select the Send notification to Mailing List toggle to activate the email notification.
16. Define the following for the email notification:

• Mailing List
• Subject of the email
• Body of the email
17. Select Finish to finalize the rule creation.
The rule displays on the RULES home screen.
Refer to the Notification Center Software User Manual for more information.

9 Best Practices for Preventing False Positives
A false positive is a bottle that flags positive on the instrument, but the Gram stain and
subculture are negative. All bottles that are flagged positive by the instrument must have a
Gram stain and subculture performed.
Investigation into the cause of false positive rates for BACT/ALERT® VIRTUO® systems have
resulted in a list of best practices that, if performed, will reduce the occurrence of false
positives. This chapter is divided into two main sections: preventing false positives by the user
and causes of false positives that are due to the instrument. Detailed descriptions of
conditions that may cause false positives are provided, along with best practices and
recommendations to prevent these conditions.
Preventing False Positives - User
This section describes conditions that may cause false positives that can be prevented by the
user.
High Amount of White Blood Cells

Infrequently, positives may occur due to a very high number of white blood cells being present
in the blood sample. This will result in smear and subculture negative samples. More than 105
leukocytes per uL of blood can be caused by hematological disease, such as leukemia, or
can be a reaction of the reticulo-endothelial system to infections. These white blood cells can
produce high amounts of CO2 that can trigger the algoritum to flag the bottle positive.
Figure 176: Cell Graph Example - High Amount of White Blood Cells
Best Practice #1 When no organisms are seen on the Gram stain, it is appropriate to reload
the bottle on the instrument. If the system determines that the bottle does not support a
positive result after the positive bottle is reloaded, then the status will revert to Negative-to-
Date and continue incubating for the duraction of the Maximum Test Time. See Handling
Unconfirmed Positive Bottles and Reloading Positive Bottles.

Blood or Sample Volume Too High Best Practices for Preventing False Positives
Blood or Sample Volume Too High

If the bottles are filled with more than 10 mL of blood, or turbid body fluid, they can be flagged
as positive because of the CO2 produced by the blood cells. An overfilled bottle may contain a
blood cell count high enough to trigger a false positive.
Figure 177: Cell Graph Example - Volume Too High
Best Practice #2 Do not fill the bottles with more than the volume recommended in the
Instructions for Use. See the Instructions for Use for each bottle type to determine the
recommended volume.
CAUTION: Do not fill the bottles with more than the recommended volume of
sample.
Large Bottle Loading and Unloading Events

If large numbers of bottles are loaded into BACT/ALERT® VIRTUO®, there may be a very
large heat transfer within the racks. This may trigger the detection algorithm to erroneously
flag positive.
Best Practice #3 To avoid triggering these conditions, follow these recommendations:
• Avoid loading over 70 bottles within one hour.
• Limit the number of bottles loaded in a single batch to no more than 40 bottles.
• Allow the batch to completely load before adding more bottles to the conveyor.
• Batches of 20 bottles is optimal. If the bank contains multiple instruments, the probability
of false positives due to heat transfer is reduced since the bottles will be loaded across all
instruments.
Temperature Changes in the Environment

The detection process of the system is sensitive to temperature changes. False positives can
occur because of temperature changes. These temperature changes can be caused by the
following:
1. The instrument door is left open for more than 10 minutes.

Temperature Changes in the Environment Best Practices for Preventing False Positives
Figure 178: Cell Graph Example - Door Open Too Long
2. Failure to close the door properly. See Opening the Instrument for Internal Access and
Closing the Door.
3. Positioning the instrument under an air conditioning or heating vent.
4. Heating or cooling differences in the lab. For example, the lab technicians on a different
shift turn up or down the heat or air conditioning, there are open windows in the
laboratory, or there are drafts that are directed at the instrument. The ambient room
temperature must be at least 9° cooler than the instrument temperature set-point
(usually 35-37°C).
5. By-passing the A unit conveyor when loading bottles and placing them directly on to a B
unit. Bottle loading should originate from the A unit and move to downstream B units to
evenly disperse the bottle across all units. Loading bottles in one area can cause a large
heat transfer to occur and cause false positives.
6. Not following the correct steps or door open recommendations when performing
Emergency Manual Bottle Loading and Unloading. The Emergency Manual Bottle
Loading and Unloading procedure should only be performed in the event that one or
more of the identified hardware failures listed in the procedure has occurred on the
instrument and there is an urgent need.
Best Practice #4 Ensure that temperature changes in the laboratory are minimized. Under
normal operation, the instrument door is not opened. To minimize the potential of false
positive determinitations or subculture recommendations, follow these temperature guidelines
when opening the instrument door:
• If the door has been open for less than 10 minutes, ensure the door is closed for a
minimum of 10 minutes before reopening the door.
• If the door has been open for more than 10 minutes, then the door should be closed as
soon as possible and remain closed for a minimum of 40 minutes before reopening the
door.
• The best way to avoid false positives after the door has been opened is to keep the door
closed for 3.5 hours before reopening. This ensures a stable temperature environment
after the door has been opened.
IMPORTANT: Bottle reflectance and output of electronics varies with temperature. Limiting
temperature fluctuations reduces the false positive rate.

Bottle Not Completely Loaded into the Cell Best Practices for Preventing False Positives
Bottle Not Completely Loaded into the Cell

False positives may occur when the bottle is not completely loaded into the cell and is later
pushed all the way into the cell. Bottles that are not seated completely into the cell can
experience a shift in reflectance, which may cause a false positive. A dropped bottle and
retension alarm may occur.
Inspect bottles for damage. Cracked bottles may experience specimen seepage behind the
LED causing a reflectance change that can trigger a false positive.
Best Practice #5 Do not disturb the bottles that are under test.
Preventing False Positives - Instrument
This section describes causes of false positives that are due to the instrument.
Cell Noise
Cells may exhibit electronic "noise" that is visible in the graph. There are three main types of
instrument noise:
1. The first type of noise is when cell graphs show irregular fluctuating signals and sharp
peaks and valleys, or large spikes in the graph. Contact you bioMérieux representative
to help determine if there are electronic issues that may be isolated and corrected.
Electro-mechanical noise above a certain threshold should be detected by the
instrument. A Bottle Placement Failure alarm, code [10], will occur if this type of noise is
detected. Every 6 hours, bottle readings are evaluated for electrical noise in the data.
This window will start over if the instrument is rebooted, if there was a gap in the data, or
if the bottle was reloaded. If electrical noise is sensed by the instrument while a bottle is
loaded into the cell, an error code [10] will be flagged for the affected cell, and the cell
will be made unavailable. If Bottle Placement Failure Alarms are triggered, verify that the
cells where the alarms are occurring as they may display a pattern. Some examples may
include: if the electro-mechanical noise issues are specific to a particular rack or if
electro-mechanical noise is infrequent.
Figure 179: Example Cell Graph Electro-Mechanical Noise
2. The second type of noise reverts to a normal graph when the bottle is reloaded into
another location. Contact your bioMérieux representative if this occurs.

High Initial-Value Readings Best Practices for Preventing False Positives
Figure 180: Cell Graph Example - Reverts to Normal
3. A third type of cell noise involves a characteristic signal pattern in the instrument that
repeats (sometimes simultaneously in multiple cells) and can cycle on a daily basis at
particulat times. It can correlate to particular events such as temperature, lighting, or
facility power events. These cyclic blips trigger a false positive event. Verify that there is
a dedicated circuit for the instrument. For example, verify that there is not a centrifuge or
a refrigerator on the same circuit as the instrument. Ensure that there are no voltage
drops at the power outlet. Also follow Best Practice #4 to minimize temperature
fluctuations.
High Initial-Value Readings

Other false positives are due to high initial-value readings in a cell that are consistent in that
cell, but normal when the positive bottle is unloaded and reloaded into another cell. If this
occurs, the cells should be calibrated. If calibrating the cells does not correct the problem,
disable and plug the cell and contact your bioMérieux representative.
Figure 181: Cell Graph Example - High Initial-Value Reading

Troubleshooting False Positive Preparation Best Practices for Preventing False Positives
Troubleshooting False Positive Preparation
If a false positive needs to be investigated by a bioMérieux representative, collect and provide

the following information to assist with troubleshooting:
• Logs (see Collect Logs)
• Database backup (see Performing a Manual Data Backup)
• Bottle IDs for the affected bottles

10 Performing System Maintenance
WARNING
When performing maintenance on a BACT/ALERT® VIRTUO® system that is
processing bottles in the racks, the door can be opened once for up to one
hour while performing maintenance and/or to decontaminate the instrument if
needed. The door cannot be opened again for a minimum of two hours to
allow the system to get back to the proper temperature. Multiple openings of
the door for short periods of time can cause issues with the temperature
controls inside the incubator. Not following these instructions can lead to
delayed results.
Rebooting the Instrument (Small Display)
Only your local bioMérieux representative can shut down the instrument. Users can reboot
the firmware using the Small Display.
CAUTION: Rebooting the instrument in any manner other than the order
listed in this procedure could result in a malfunction of the instrument.
Note: Before rebooting the instrument, ensure the bottles have been unloaded from the bottle
retrieval area.

Figure 182: Information Button
2. Select Instrument Firmware Reboot.
Figure 183: Instrument Firmware Reboot Button
3. Select the Check button to reboot or the Cancel button to quit.
Rebooting the Internal PC (Large Display)

To reboot the internal PC:
Select Start > Restart.

Starting Up the Instrument Performing System Maintenance
Note: Rebooting the internal PC can take up to 15 minutes.
Starting Up the Instrument
1. Ensure the power cord is securely connected to the power cord connector. The power
cord and power switch are located at the bottom front of the instrument behind the
blue kick plate.
Figure 184: Power Cord Connector and Power Switch
1 Power Cord Connector

2 Power Switch
2. Position the Power Switch to the ON position.
Note: The software, firmware, and Internal PC operating system will initialize.
IMPORTANT: A screen may appear with a message that states that a valid instrument bank
must be selected. For stand-alone configurations, it is only required to press
the refresh button.
Restoring Data
Contact your local bioMérieux representative to restore from a data backup.

Automated Backups Performing System Maintenance
CAUTION: The following data will be lost when you attempt to restore data.
• All edits (such as the following) that have been done since the backup was
made will be lost:
◦ Anonymous bottles that were identified
◦ Bottles where the accession ID was changed
◦ Positive results that were user-changed
• The instrument temperature data since the date of the backup being
restored will be lost.
• In standalone mode, the following will be lost:
◦ All audits that were made since the backup
◦ Any users created in the bioMérieux User Management System since
the backup
Note: Audits that were made since the backup and related to instrument data will be rebuilt. The
PC and firmware can restore some of the data and send to the PC (for example, bottle loads
and unloads). The firmware only stores up to 7 days of this data, however.
Automated Backups
Cobian Backup is the software used to backup the BACT/ALERT® VIRTUO® data to a
dedicated hard disk, an external USB drive, or a network directory.
Every day, the Cobian Backup software is configured to systematically back up all the
BACT/ALERT® VIRTUO® data:
• It produces a backup file every Monday, Wednesday and Friday.
• It produces another backup file every Tuesday, Thursday and Saturday.
• It produces a final backup file every Sunday.
This backup method ensures all the data for a week are backed up.
Scheduling Automated Backups
Table 32: Cobian Icons

Cobian Backup Start scheduling automatic backup process.
Start Start Cobian Backup task.

Configuring the Backup Performing System Maintenance
Figure 185: Accessing the Cobian Backup Interface
From the Cobian backup interface:

1. Select Cobian Backup.
2. Select Backup A, Backup B, or Backup WE.
3. Select Edit Task.
4. Select Dynamics.
5. Enter the number of full copies to keep.
6. Select OK..
Note: Ensure that an external USB device is inserted in the PC for scheduled automated
backups.
Configuring the Backup
Backup configuration is carried out by or under the guidance of a bioMérieux representative.
Performing a Manual Data Backup
1. Ensure that an external USB drive is inserted, assigned to the F drive, and available
for the manual backup.
2. Select Expand in the system notification tray to show the hidden icons.
Figure 186: Expand Icon

Performing a Manual Data Backup Performing System Maintenance
Figure 187: Hidden Icons
3. Right-click Cobian.
Figure 188: Cobian Icon
4. Select Open.
5. Select Backup Manual.
Figure 189: Cobian Backup Manual
6. Select Run Selected Task.
Figure 190: Run Selected Task
The Cobian Backup 11 window appears.

7. Select OK.
Do not check the Shutdown the computer when done box.
Backup information appears in the right pane of the Backup-Manual Log screen. The
Cobian Manual Backup status bar on the bottom-right of the screen shows the
progress of the backup.
Figure 191: Cobian Manual Backup Status Bar
8. After the Cobian manual backup is completed, Backup done appears on the Backup-
Manual Log screen.
Figure 192: Backup-Manual Log Screen

Disinfection Procedures Performing System Maintenance
The backup information is saved in the configured backup destination.
Disinfection Procedures
WARNING
A potential biohazard exists in these situations:
• A bottle is not correctly identified.
• A bottle leaks from damage or another cause.
• Entrapped biohazard substances are not properly cleaned.
• Proper cleaning guidelines are not correctly followed.
• Surfaces are not cleaned properly.
Bottle Leaks
WARNING
A consequence of bottle leaks may be delayed or false positive results.
Determine if a bottle has leaked inside the instrument.

Inspect positive bottles for evidence of a leak such as red flakes on the bottle, bottle return
chute, or indexer cover.
If evidence of a leak appears, open the instrument and look for further evidence of leaks on
the drip tray, racks, or the inside of the door.
Follow your institution's recommended procedure for decontamination or the procedure
described in the latest revision of Clinical and Laboratory Standards Institute (CLSI®)
guideline "Protection of Laboratory Workers from Instrument Biohazards and Infectious
Disease Transmitted by Blood, Body fluids, and Tissue ” CLSI® Document M29-A.
Approved Disinfection Agents

The following families of disinfection agents are approved to use with
BACT/ALERT® VIRTUO® with no impact to results or performance after cleaning:
Note: Refer to the product labeling for any cleaning or disinfection agents that may be used to
ensure proper handling of any potentially caustic substances.
• 10% sodium hypochlorite (bleach) of 700 PPM free chlorine solution (13 mL of 5.25%
bleach to 1 liter of tap water)
• 3–25% hydrogen peroxide (wipe down)
• hydrogen peroxide (vapor phase)
• EPA registered tuberculocidal disinfectants (safe for use with polycarbonate)
WARNING
Use only polycarbonate-safe agents to avoid the risk of leaking bottles or
incorrect results.

Cleaning a Spill Performing System Maintenance
WARNING
Note: When performing tuberculocidal decontamination, some cleaning agents may cause
discoloration on instrument surfaces over time.
Cleaning a Spill
Where appropriate, follow your laboratory's spill cleanup procedures.
1. Gently cover the spill area with a paper towel. Apply a 10% bleach solution or other
EPA registered tuberculocidal disinfectant.
2. Using the bleach solution, wet down all surfaces where the spill may have come in
contact.
3. Allow all surfaces adequate contact time with the bleach solution (15–30 minutes)
before cleanup.
4. Treat all materials used in the cleanup as biohazardous waste.
Disinfection Procedure for Spills On the Instrument

Using the following procedure, immediately remove any blood or test sample spilled on an
instrument.
WARNING
Always wear protective gloves when handling blood, blood components, or
bloodcontaminated material.
WARNING
Handle samples and inoculated culture bottles as though capable of
transmitting infectious agents. Autoclave all inoculated bottles, sample
collection needles, and blood drawing devices before discarding.
WARNING
The potential exists for bottle damage and leaking. Damaged and leaking
bottles may cause delayed or false positive test results.
1. Clean the spill from the instrument.

Disinfection Procedure for Spills In the Instrument Performing System Maintenance
Note: Follow your institution's recommended procedure for decontamination or the

procedure described in the latest revision of Clinical and Laboratory Standards
Institute (CLSI®) guideline "Protection of Laboratory Workers from Instrument
Biohazards and Infectious Disease Transmitted by Blood, Body fluids, and Tissue”
CLSI® Document M29-A.
2. After decontamination, wipe with damp (water only) towel and thoroughly dry.
Note: For mycobacteria spills see Disinfecting for Mycobacteria Contaminants.
Disinfection Procedure for Spills In the Instrument

Using the following procedure, immediately remove any blood or test sample spilled in an
instrument and decontaminate the affected areas.
1. Open the instrument door and ensure the kickstand engages so that the door is
supported.
CAUTION: Do not keep the door open for more than 10 minutes as that
may result in temperature loss and affect bottle test results.
2. Visually inspect the extent of the leakage or spill. Determine if one or more racks is
contaminated.
3. Remove the leaking bottle if possible.
Note: If a bottle becomes lodged in the cell, call bioMérieux. Do not try to dislodge a bottle
by pulling on the rack. You may need to subculture the bottle.
4. Unload all bottles from the affected racks.

5. Decontaminate bottles as needed.
6. Place the bottles on the conveyor to reload.
Note: Do not reload bottles affected by the spill until they have been decontaminated.
Follow your institution's recommended procedure for decontamination or the
Institute (CLSI® guideline "Protection of Laboratory Workers from Instrument
7. If an affected cell contains a large amount of liquid, carefully aspirate it using a pipette
or similar device, and dispose of it in an appropriate biohazardous waste container.
8. If the spill is confined to one or a few cells of one rack, clean and disinfect the affected
cells with an approved disinfection agent, following the steps in Cleaning the Bottle
Racks.
WARNING
CIDEXPLUS® 28 Day solution) to clean the rack cover plate. Failure to
comply results in damage to the rack cover plate.

Cleaning the Robot Gripper Pads Performing System Maintenance
CAUTION: Do not expose the cell or rack to the approved disinfection

agent for an extended period. Do not use an unapproved disinfectant
or a bleach solution stronger than 10% or damage to cell components
may occur.
Note: For more extensive spills, decontaminate bottles, cells, and racks. Contact your local
bioMérieux representative for instructions to relocate or disable affected cells or
racks.
Note: Follow your institution's recommended procedure for decontamination or the

9. Although a plate covers the cables, verify that the leak did not contaminate the cables
at the bottom of the instrument. If the spill leaked onto the cables, contact your local
bioMérieux representative.
Cleaning the Robot Gripper Pads
Clean the robot gripper pads when they are visibly dirty or when instructed by a bioMérieux
representative. Wipe the gripper pads using gauze and the approved cleaning agent to
remove dirt, debris, adhesive buildup, or contaminants.
Dampen the robot gripper pads when cleaning. Do not soak the pads.
CAUTION: Soaking the gripper pads may cause adhesive debonding.
Cleaning the Conveyor
Clean the loader conveyor belt surface when it is visibly dirty or when bottles start tipping
over. Use silicone wipes (418007) to wipe the conveyor surface.
1. Wipe the conveyor surface that is visible with silicone wipes (418007) to lubricate.
2. Place a hand above the conveyor to activate the light curtain sensors.
The conveyor advances forward.
3. Wipe this section of the conveyor surface that is visible.
4. Continue in this manner until the entire conveyor is lubricated.
CAUTION: Do not get lubricant on the sensors.

Outer Instrument Panels Performing System Maintenance
Outer Instrument Panels
Outer instrument panels should only be removed by a bioMérieux representative.

Contact your local bioMérieux representative for assistance.
WARNING
Operating the instrument with any of the outer instrument panels removed
may lead to incorrect results.
Clean the outer instrument panels when they are visibly dirty or when directed by a
bioMérieux respresentative.
Wipe the outer instrument panels with gauze and an approved cleaning agent, except
hydrogen peroxide (vapor phase). See Approved Disinfection Agents.
Removing a Bottle Rack Cover Plate
Before removing a bottle rack for cleaning, unload all bottles from the bottle rack.
1. Locate the bottle rack fasteners (screws) below bottle cells 2, 7, and 12.
Figure 193: Bottle Rack Assembly
1 Screws
2. Use a 3 mm T-handle or Allen wrench to loosen the screws.

3. Remove the bottle rack assembly.
WARNING
Carefully put the bottle rack assembly back in the instrument so as not
to damage the bottle rack. The consequences of damaging or
distorting the bottle rack may be delayed results.
Cleaning the Rack Cover Plate
Clean the rack cover plate if it is visibly dirty or when instructed by a bioMérieux
representative.
1. Remove the bottle rack following the steps in Removing a Bottle Rack Cover Plate.
2. Wipe the rack cover plate with gauze and a cleaning agent.
See Approved Disinfection Agents.

Cleaning the Rack Cover Plate Performing System Maintenance
CAUTION: Use only polycarbonate-safe agents to avoid the risk of

leaking bottles or incorrect results.
WARNING
CIDEXPLUS® 28 Day solution) to clean the rack cover plate. Failure to
comply results in damage to the rack cover plate.
Note: Saturate the gauze but not so much that liquid drips.
3. Wipe the rack cover plate with gauze and distilled water.
4. Use a dry gauze to lightly remove any residual water spots on the rack cover plate.
CAUTION: Do not scratch the rack cover plate.
5. Reinstall the bottle rack assembly over the rack cover plate.
6. Tighten the three bottle rack assembly fasteners, ensuring proper orientation.
WARNING
The consequences of not tightening the screws may be delayed
results.
WARNING
CAUTION: The bottle rack assembly come loose or prevent proper

robot alignment if not reinstalled correctly.
WARNING
Carefully place the bottle rack assembly back in the instrument so as
not to damage the laser alignment features. The consequences of
damaging or distorting the laser alignment may be delayed results.

Cleaning the Bottle Racks Performing System Maintenance
Cleaning the Bottle Racks
Clean the bottle racks when they are visibly dirty or when instructed by a bioMérieux
representative.
Note: If the rack cleaning takes longer than two hours, some of the bottles will be marked for
subculture when they are reloaded. If the rack cleaning takes longer than four hours, all the
reloaded bottles will be marked for subculture.
Note: Follow your institution's recommended procedure for decontamination or the procedure
described in the latest revision of Clinical and Laboratory Standards Institute (CLSI®)
guideline "Protection of Laboratory Workers from Instrument Biohazards and Infectious
Disease Transmitted by Blood, Body fluids, and Tissue” CLSI® Document M29-A.
WARNING
CAUTION: Do not expose the cell or rack to the approved disinfection agent
for an extended period. Do not use an unapproved disinfectant or a bleach
solution stronger than 10% or damage to cell components may occur.
WARNING
Failure to properly adhere to the bottle rack cover plate cleaning instructions
may lead to delayed results.
Note: The bottle rack is designed to be dishwasher safe, if necessary.
Note: Do not autoclave the bottle racks.
1. Remove the bottle rack following the steps in Removing a Bottle Rack Cover Plate.
2. Wipe the exterior and interior cells regions with gauze and recommended cleaning
agents. See Approved Disinfection Agents
3. Place the bottle rack in a dishwasher, if necessary.

4. Visually ensure the rack cover plate is free from liquid that may have leaked from a
bottle.

Disinfecting for Mycobacteria Contaminants Performing System Maintenance
5. Reinstall the bottle rack assembly over the rack cover plate.
6. Tighten the three bottle rack assembly fasteners, ensuring proper orientation.
WARNING
The consequences of not tightening the screws may be delayed
results.
WARNING
CAUTION: The bottle rack assembly may fall or prevent proper robot
alignment if not reinstalled correctly.
WARNING
Carefully place the bottle rack assembly back in the instrument so as
not to damage the laser alignment features. The consequences of
damaging or distorting the laser alignment may be delayed results.
Disinfecting for Mycobacteria Contaminants
Follow your institution's recommended procedure for decontamination.

Contact your local hydrogen peroxide vapor phase representative for the decontamination
process.
Decommissioning BACT/ALERT® VIRTUO®
To decommission an instrument:
1. Follow your institution's recommended procedure for decontamination or the
Biohazards and Infectious Disease Transmitted by Blood, Body fluids, and Tissue ”
WARNING
A potential biohazard exists if proper cleaning guidelines are not
correctly followed.
2. Contact your local bioMérieux representative.

bioMérieux will dispose of the instrument properly.

A Appendix - Glossary
Accession (Clinical Use)

A sample collected from a patient during a single event.
Accession Number (Clinical Use)
A number that uniquely identifies the patient sample.
Anonymous Bottle
A bottle with a missing bottle ID or a missing bottle type, may be due to failure to read the
bMx ID, scanner malfunction, or manual load. Bottles loaded anonymously must eventually be
identified and assigned a bottle ID.
Alternate ID
A barcode for bottle ID replacement, usually created by a laboratory information system.
Audible Alarm
Specified by the user to flag positive bottles or notify the user of alarms or alerts.
BACT/ALERT® VIRTUO® Microbial Detection System
bioMérieux’s automated instrumentation to screen test specimens in clinical use for the
presence of microbes.
Bank
A single A unit or an A unit with up to 3 B units physically connected.
bioMérieux Middleware
bioMérieux's middleware solutions, including MYLA® and MAESTRIA™.
Bottle Graph
A line graph that plots the microbial activity in a culture over time.
Bottle ID
A barcode that uniquely identifies a single culture bottle.
Bottle Indexer
Transfers the loaded bottles to the inside of the instrument where the bottle label is scanned
and the bottle is positioned for loading.
Bottle Retrieval Area
Location where positive bottles are automatically unloaded.
Bottle Return Chutes
Small channel that bottles move through to be automatically unloaded to the bottle return
area.
Bottle Type
A bottle with a specific type of culture medium.
Cell
Holds and monitors one culture bottle. Each cell is designated with a number from 1 to 27.
®
CLSI
Clinical and Laboratory Standards Institute
050574-02 A-1 BACT/ALERT® VIRTUO®

Appendix - Glossary
Generic Bottle ID
A bottle ID that does not indicate one of the predefined bottle types.
Handheld Barcode Scanner
Scanner that is plugged into the instrument and scans data from a barcode into the software
and displays information for a bottle.
Internal Barcode Scanner
Scanner that is plugged into the instrument and scans data from a barcode into the software
and displays information for a bottle.
Laboratory Information System (LIS)/Blood Establishment Computer System (BECS)
A customer maintained computer (usually a mainframe) or computerized system that collects
information from laboratory instruments.
Large Display
The large touchscreen that provides bottle and system information for the associated banks.
Loading Area
Automatically loads from one to 40 bottles into the instrument at a time.
Negative
Describes a culture bottle that has no evidence of microbial activity.
Negative to Date
Describes a culture bottle that is under test and a final result has not yet been determined.
Positive
Describes a culture bottle that has evidence of microbial activity.
Rack
Contains 27 cells, each of which can hold and monitor an individual culture bottle. Racks
gently rock to agitate blood culture bottles. The racks are designated with a letter from A to P.
Rack Detection Assembly (RDA)
Holds four racks and controls agitation (rocking).
Robot Arm
A gripper that retrieves bottles from the bottle indexer and automatically loads bottles to an
available cell and unloads bottles to either the waste container or the bottle return chutes
(depending on bottle status and how the instrument is configured).
Small Display
Small touchscreen that displays instrument temperature and provides a means of manually
loading and unloading bottles. This display is primarily for individual instrument status and
maintenance.
Stabilizing Feet
Feet that adjust to prevent movement.
Unconfirmed Positive
Describes a bottle the system determined to be positive but no confirmation is available by
gram stain or subculture.
Waste Container
The receptacle that holds all negative bottles that are automatically unloaded.
050574-02 A-2 BACT/ALERT® VIRTUO®

Revision History
This section contains a summary of changes made to each released revision of this document
starting with part number:
050574-01
Change type categories
N/A Not applicable (First publication)

Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Notes: • Minor typographical, grammar, and formatting changes are not

included in the revision history.
• Not all versions may be available in all languages.
Release Part
Change Type Change Summary
Date Number
Safety Information:
Technical
2022-09 050574-02 • Instrument Labels: Replaced A and B unit instrument label figures.
change
• Safety Precautions: Changed powder-less to powder free gloves.
System Overview:
• Introduction to BACT/ALERT® VIRTUO®: Reword for clarity. Clarify
that the fill-to line is not etched on the bottle. Removed statement that
sample unloads to the waste container.
• Multi-Instance Site Configuration: Replaced figure. Removed system
version limitation.
• Primary Secondary Site Configuration: Replaced figure. Added and
removed limitations.
• Communication Loss: Replaced figure.
• Identifying Primary and Secondary Banks: Replaced figure and
Technical added callouts. Removed Secondary A Unit System Information
change figure.
• Bottles Supported for Use: Added BPA US and BPN US.
• Physical Characteristics: Added sound emission for loading bottles.
Clarified above sea level.
• Large Display: Replace table icons.
• Small Display: Reword for clarity. Removed wording below table.
• Buttons: Replaced figure.
• Common System Buttons: Replaced icons. Added calendar icon.
• Common Edit and Configure Screen Elements: Replaced figure.
• Search Criteria Screen Icons: Replaced icons. Added Group MTT
Edit icon.
Release Part
Date Number
Basic Functions:
• Introduction: Corrected records and data to information.
• Zone 1: Corrected User Security to User Management.
• Zone 3: Replaced icons.
• Display Bank Screen: Added Number of Available Cells.
• System Log In: Corrected User Security to User Management.
• Applying a Barcode Label to a Bottle: Added 2D barcodes. Removed
old bottle label. Replaced figure. Corrected fill-to line to fill mark.
Added Information for Use reference number. Added do not write on
bottom of bottle to warning.
• Loading Bottles Automatically: Modified warning to include
application. Replaced figures.
• Canceling a Bottle Test: Moved step 4. Replaced figures.
• Handling Unconfirmed Positive Bottles: Added guidance for reloading
positive bottles.
• Unloading Specific Bottles by User Request: Added caution.
• Searching for Specific Bottle Information: Replaced figures.
• Searching by Patient ID: Added note for deleting patient data.
• Searching by Bottle Type: Updated to reflect current interface.
Replaced figure.
• Searching by Sample Type: New section.
• Using Additional Search Criteria: Updated to reflect current
interface.Replaced figure.
• Searching by Instrument Name: Replaced figure.
Technical
• Search Results Screen: Replaced figure.
change
• Accessing the Bottle Status Information Screen: Replaced figure.
Added and replaced icons.
• Editing Bottle Record: Replaced figure.
• Editing Patient Information: Clarified note. Replaced figures.
• Processing Expired Bottles: Replaced figure.
• Identifying an Anonymouse Bottle with a Visible bioMérieux Label:
Replaced figure. Added note.
• Identifying an Anonymouse Bottle without a Visible bioMérieux Label:
Replaced figures. Added note.
• Unloading, Relabeling, and Reloading a Previouslt Identified
Anonymouse Botte: Replaced figure.
• Zooming and Rotating Bottle Label Image: New section.
• Generating Bottle Reports in Standalone and Site Configuration
(MAESTRIA™): Updated title to specify MAESTRIA™ site
configuration. Added Note.
• Generating Bottle Reports in Site Configuration (MYLA®): Updated
title to specify MYLA® site configuration. Updated to reflect current
interface.
• Generating an Hourly Temperature Detailed Report: Replaced
figures.Updated to reflect current interface.
• Generating a Daily Average Temperature Report: Replaced
figures.Updated to reflect current interface.
• Generating an Instrument Cell Calibration Report: Replaced
figure.Updated to reflect current interface.
Release Part
Date Number
• Updated to reflect current interface.
• Configuring Bottle Type Settings: Replaced figure. Updated to reflect
current interface.
• Sample Volume Measurement: Updated note for default
configuration.
• Setting the Sample Upper Variation: Updated to reflect current
interface.
• Configuring Bank Settings: Replaced figure.
• Naming Instruments: Replaced figure.
• Configuring Sound Settings: Added note. Replaced figure.
• Configuring Sound and Volume: Removed note. Added warning for
disabling alarms.
• Configuring Alarm Settings: Replaced figure. Updated to reflect
current interface.
• Configuring General Software Settings: Added Note. Replaced
figure.Updated to reflect current interface.
Technical • Using Patient Data: Updated note.
change
• Measuring Sample Volume: New section.
• Configuring Remote Notification: New section.
• Accessing the Notification Center Dashboard: New section.
• Archiving Bottle Data: Removed Important statement. Added note.
Updated to reflect current interface.
• Accessing the BCI Connect Dashboard: Updated to reflect current
interface.
• Enabling 21 CFR 11 Settings: Replaced figure.
• Configuring LIS Settings: Added standalone configuration only.
Replaced figure.Updated to reflect current interface.
• Uploading Bottle Results: Updated to reflect current interface.
• Setting Date Range: Added date range options.
• Adding Columns to a Report: Added minimum and maximum
requirements.
• Managing User Account and User Groups: Updated to reflect current
interface.
• Configuring External Users in User Management: New section.
Emergency Manual Bottle Loading and Unloading:

• Emergency Manual Unloading Positive Bottles: Updated note.
Technical
Replaced figure.
change
• Emergency Manual Loading Bottles: Removed note. Replaced figure.
• Emergency Manual Unloading Anonymous Bottle: Replaced figure.
Troubleshooting
• Updated the following bottle alarms and alerts: 3, 8, 14, 19, and 47.
• Updated the following instrument alarms and alerts: 7, 10, 20, 41, 59,
and 97.
• Updated the following software and communication alarms and alerts:
Technical 31 and 38. Added the following alarms and alerts: 108, 109, 110, and
change 111.
• Opening the Instrument for Internal Access: Added warning.
• Audit Trail: Created separate sections for Standalone and Site
Configuration (MAESTRIA™) and for Site Configuration (MYLA®).
• Collect Logs: New section.
• Notification Center: New section.
Technical
Best Practices for Preventing False Positives: New section.
change
Release Part
Date Number
Performing System Maintenance:

• Scheduling Automated Backups: Replaced figure.
• Disinfection Procedure for Spills in the Instrument: Changed warning
to caution.
Technical • Cleaning the Robot Gripper Pads: Added when to perform the
change cleaning.
• Outer Instrument Panels: Added when to perform the cleaning.
Added cleaning instructions.
• Cleaning the Rack Cover Plate: Added when to perform the cleaning.
• Cleaning the Bottle Racks: Added when to perform the cleaning.
Technical
Glossary: Added bioMérieux middleware.
change
Throughout:
• Added MAESTRIA™.
Administrative • Replaced MYLA® with bioMérieux middleware when referring to
MYLA® and MAESTRIA®.
• Changed customer to user.
General Information:
• Added Serious Incident statement.
Administrative • Warning and Safety Messages: Moved from Introduction to the
System to General Information.
• Intellectual Property: Corrected Virtual Patent Marking web address.
Standard Symbols:
Administrative
• Added Importer symbol and definition.
System Installation and Setup:

Administrative
• Windows Environment: Added registered mark to Windows®.
System Configuration:
Administrative • Sending Negative to Date Messages to the LIS upon Loading Bottles:
Added Negative to Date to the title.
Troubleshooting:
• Opening the Instrument Door: Reworded for clarity.
Administrative
• Closing the Door: Removed duplicate note.
• Unjamming the Robot: Reword for clarity.
Technical Introduction to the System: Updated intended use to include use of

2019-08 050574-01
change system in blood bank facilities.
Technical Safety Information: Clarified information regarding use of USB devices

change with system.
Release Part
Date Number
System Overview:
• System Configuration: Updated definition of instrument bank and
available bank configurations.
• Multi-Instance Site Configuration: Added section and sub-sections.
• Primary/Secondary Site Configuration: Added section and sub-
sections.
• Bottles Supported for Use: Added BACT/ALERT® BPA and BPN
bottles for industry blood bank use. Updated warning about use of
non-bioMérieux and/or unsupported bottles to indicate that such
bottles are no longer rejected in R3.0.
• Additional Supplies: Removed MYLA® remote notification tower.
Technical • Principle of Detection: Edited information about CO2 production for
change accuracy. Updated warning to remove industry blood bank use as an
off label use of the system.
• BACT/ALERT® VIRTUO® Hardware: Updated call-outs for A-Unit and
B-Unit "Front View" figures.
• BACT/ALERT® VIRTUO® Screens: Added note about untranslated
text in user interface.
• Large Display: Added note about slow PC performance.
• Small Display: Added note about system power loss or reboot.
Updated "Manual Load Bottle" description. Added "Ready to Load"
icon and description. Updated "Bottle Return Chutes" figure.
• Search Criteria Screen Icons: Updated "Upload" icon description to
include LIS.
System Installation and Setup:

• Installing Windows® Security Updates: Added section.
Basic Functions:
• Zone 2: Added note about the Snooze button.
• Zone 5: Updated to reflect user interface in R3.0.
• Remote Notification: Removed section because it pertains to MYLA®
• Applying a Barcode Label to a Bottle: Added "Correct Label
Placement" figures for old and new bottle labels.
• Loading Bottles Automatically: Updated warning about use of
unauthorized bottles to indicate that test result for such bottles are no
longer suppressed in R3.0. Added warning about removing index
cover. Added note about poor quality bottle images. Updated
"Example of Scanned Bottle Image" figure to show new bottle label.
• Unloading Positive Bottles Automatically: Moved warning about
subculturing negative to date bottles to "Unloading Bottles by User
Request" section.
Technical • Handling Unconfirmed Positive Bottles: Updated warning about
change reloading bottles across banks with information about Primary/
Secondary.
• Data Retention Period for Bottle Information: Updated to reflect
functionality in R3.0.
• Searching for Specific Bottle Information: Updated sub-sections,
including figures, to reflect search functionality in R3.0.
• Searching by Patient ID: Added sub-section to "Searching for Specific
Bottle Information" section.
• Search Results Screen: Added explanation of bottle location. Added
notes about search criteria and Page Scroll buttons.
• Accessing the Bottle Status Information Screen: Updated "Upload"
icon description to include the LIS. Added "Revert" icon and
description. Added step to view patient demographic information in
site configuration.
• Editing a Bottle Record: Removed note about Revert icon.
Release Part
Date Number
Basic Functions (continued):

• Editing Patient Information: Combined several sections from prior
revision due to relevance.
• Entering the Accession ID: Moved instructions to "Editing Patient
Information" section.
• Processing Expired Bottles: Updated warning about use of expired
bottles to address blood bank users. Updated to reflect functionality in
R3.0.
• Reloading Positive Bottles: Added further explanation about "Positive
Bottle Reloaded" message. Added further explanation to note about
reanalysis of positive bottles.
• Identifying an Anonymous Bottle: Combined two sections from prior
revision due to relevance.
Technical • Viewing and Printing a Bottle Label Image: Added note about
change availability of bottle label images.
• Viewing a Graph: Added note about availability of bottle readings
graphs. Added note about zooming into a graph.
• Bottle Reports: Updated section and "Generating Bottle Reports" sub-
sections to reflect reporting functionality in R3.0. Removed "Altering
Bottle Reports" sub-section because it pertains to MYLA®.
• Generating an Hourly Temperature Detailed Report: Updated "In
Range" field description.
• Generating a Daily Average Temperature Report: Updated "Out of
Range/Day" field description.
• Generating an Instrument Cell Calibration Report: Added further
explanation about the instrument cell calibration report.
• Capacity of the Waste Container: Updated waste capacity from 72 to
50 bottles.
• Chapter introduction: Added new system configuration settings.
Moved warning about configuring accession IDs to "Enabling
Barcodes on Bottles and Defining Validation Patterns" sub-section.
• Sample Volume Measurement: Added note about enabling sample
volume measurement.
• Naming Instruments: Added "Location" column call-out to "Naming
Instruments" figure.
• Naming Banks and Labs: Updated important note about naming
banks.
• Configuring General Software Settings: Added new general software
Technical
settings.
change
• Configuring Data Retention and Accession ID Reuse: Added sub-
section to Configuring General Software Settings.
• Archiving Bottle Data: Added sub-section to Configuring General
Software Settings.
• Configuring LIS Settings: Added section and sub-sections.
• Configuring Bottle Report Settings: Added section and sub-sections.
• Configuring LIS/Export: Removed section because it pertains to
MYLA®.
• Password Policy: Added important note regarding system
configuration. Updated maximum password age for high security
level.
Release Part
Date Number

• Chapter introduction: Updated warning about reloading bottles that
were already in the system. Changed icon name to "Display
Unavailable Cells" throughout.
Technical • Emergency Manual Loading Bottles: Updated note about loading
Change bottles to avoid false positives.
• Discrepancy in the Manually Loaded Bottle Count: Added step to
display list of unavailable cells.
• Anonymous Bottle Alert after Manual Loading: Reorganized section
to indicate appropriate response to anonymous bottle alert for various
scenarios.
Troubleshooting
• Updated the following alarm or alert codes:
◦ Negative bottle(s) was reloaded. [32]
◦ Unmatched reloaded bottle has resulted in a duplicate bottle
record. [36]
◦ Bottle unable to be removed from cell. [83]
◦ Duplicate bottle was detected in another instrument. [99]
◦ Bank capacity has reached the configured threshold. [4]
◦ Bottle(s) on the conveyor cannot be loaded due to lack of bank
capacity or a malfunction/jam. [5]
◦ A bottle was placed in a cell that has become non-operational.
[10]
◦ The embedded software has rebooted on the listed instrument(s).
[65]
◦ Bottle readings are not being taken because the instrument is out
of range. [80]
◦ Communication has been lost with the listed instrument(s). [28]
◦ Communication has been lost with the listed instrument(s). [29]
Technical
• Added the following alarm or alert codes:
change
◦ Problem with a bottle(s) on the conveyor of the listed
instrument(s). [59]
◦ BCI CONNECT general error. [103]
◦ Archive failure. [104]
◦ Loss of communication with BCI CONNECT. [105]
◦ Bottle matched an old accession number. [106]
◦ Bottle send to BCI CONNECT failed. [107]
• Removed the following alarm or alert codes:
◦ An unknown LIS code was received. [24]
◦ Communication is unavailable between the instrument and the
LIS. [25]
◦ Unexpected LIS error. [26]
• Opening the Instrument for Internal Access: Added further
explanation about Robot Activity indicator.
• Closing the Door: Updated warning about placing robot gripper in
safe to move position.
• Unjamming the Robot: Updated note about reserved cells for
calibration standards.
Performing System Maintenance:

Technical
change • Rebooting the Instrument (Small Display): Added note about
unloading bottles from retrieval area prior to reboot.
Aligned with current User Manual template. Updated branding

Administrative
throughout.
Release Part
Date Number
The following sections, including sub-sections, were edited for clarity

and/or consistent terminology:
• Introduction to BACT/ALERT® VIRTUO®
• BACT/ALERT® VIRTUO® Hardware
• Monitoring the System
• Applying a Barcode Label to a Bottle
• Loading Bottles Automatically
• Unloading Bottles Automatically
• Unloading Bottles by User Request
• Managing Bottle Information
• Accessing the Bottle Status Information Screen
Administrative
• Managing Bottle Information
• Identifying an Anonymous Bottle
• Unloading, Relabeling, and Reloading a Previously Identified
Anonymous Bottle
• Viewing and Printing Reports
• Emptying the Waste Container
• Configuring Bottle Type Settings
• Configuring Bank Settings
• Managing User Accounts and User Groups
• Emergency Manual Loading Bottles
• Rebooting the Instrument (Small Display)
Applied global PLD template. Changed "Bank Display" to "Large Display"

514927-1E Technical
2016-03 throughout. Changed "Calibration slug or reference" to "Calibration
N1 change
standard." Changed time door could be open from 15 to 10 throughout
Technical
Updated warranty and liability disclaimer.
change
Technical Introduction: Added chapter per template and changed all references to
change package insert to IFU.
Technical
Safety Information: Added chapter and updated label
change
System Overview:
• Physical Characteristics: Added B Unit weight, heat transfer, and
power consumed specifications.
• System Configuration: Removed network and site configuration.
• General Instrument Configuration: Added B Unit specifications.
• Bottles Supported for Use: Changed description of PF bottle.
Technical • Bottles Not Supported for Use: Removed MB bottle.
change • BACT/ALERT® VIRTUO® Hardware: Added B unit images and
specifications and images for transfer arm, transfer gate, and safe to
move sensor.
• Modified temperature probe warning.
• Small Display: Updated images and icons. Removed paragraph
under table.
• Search Criteria Screen Icons: Added new icons.
• Additional Supplies: Added list of additional components.
Release Part
Date Number
Basic Functions
• Home Screen: Updated images and icons.
• System Login: Updated Figure 21.
• Password Policy: Removed section.
• Applying a Barcode Label to a Bottle: Added color specifications for
bottle labels. Added fill-line to Figure 32.
• Handling Unconfirmed Positive Bottles: Added step to login. Moved
warning about transfer of bottle. Added note to step 3.
• Loading Bottles Automatically: Modified warning on loading bottles;
added instructions for loading batches of bottles; modified steps in
procedure.
• Unloading Positive Bottles Automatically: Changed wording around
"removed" and "unloaded" and modified note.
Technical
• Canceling a Bottle Test: Modified step 3.
change
• Updated Figure: 26, 29, 33, 34, 35, 36, 43, 45, 47, 48, 54, 61, 63, 65,
67
• Using Additional Search Criteria: Added criteria and note.
• Searching by Contaminated: Added instructions on search criteria.
• Reloading Positive Bottles: Modified procedure.
• Editing a Bottle Record: removed note about Labsuper role and
modified precedence rules note. Added waning about physical
keyboard.
• Altering Bottle Reports: Added section.
• Viewing and Printing Bottle Reports: Added definition for anonymous
bottles; added steps to view reports.
• Emptying the Waste Container: Added note.
• Added section Loading Bottles Across a Bank
• Removed general software configuration setting.
• Identifying an Anonymous Bottle Without a Visible bioMérieux Label:
Replaced image.
• Added sections on Exporting Archive Records and Viewing Archive
Records
• Naming Banks and Labs: Added note on special characters.
Technical • Replaced Figure 81 and 83.
change • System Configuration: Remove sections on MYLA® import and
export.
• Disabling 21 CFR 11 Settings: Added instructions of how to configure
settings for individuals.
• Sample Volume Measurement: Added paragraphs on how sample
volume measurement works.
• Viewing Archive Records: Added step to procedure.
• User Management Groups: Added resolving LIS codes to MYLA®
LabTech role.

• Sample Volume Variation: Removed note about checking bottle fill-to
image.
• Added temperature guidelines.
Technical
change • Emergency Manual Unloading Positive Bottles: Remove note under
Figure 86. Incorrect information.
• Updated Figure 92 and 99.
• Discrepancy in the Manually Loaded Bottle Count: Added note after
step 9.
Release Part
Date Number
Troubleshooting:
• Updated Figure 95; added entry to Table 18.
• Added caution and warnings about time and temperature loss.
• Removed the following error codes:
◦ Instrument Automatically Rebooted Alarm [65]
◦ LIS Patient Conflict Alarm [27]
◦ MYLA® Rejected Message [101]
• Added the following codes:
◦ Bottle Transfer Error [93]
◦ Conveyor Cover Off [94]
◦ Transfer Gate Open [96]
◦ Bank Capacity Exceeded changed to No Space Available [5]
◦ Bottle Not Know by PC [97]
◦ Duplicate Bottle in another instrument [99]
Technical ◦ Incompatible Firmware version [98]
change ◦ Knowledge Base update [100]
• Added definition for jam and malfunction.
• Modified the following alarms: 2, 7, 13, 18, 33, 12, 20, 25, 28, 29, 35,
40, 44, 48, 53, 55, 59, 63, 67, 68, 69, 70, 71, 72, 74, 80, 81, 82, 83,
86, 89, 90, 93, 94, 96, 97, 98, 99.
• Unexpected Conditions: Modified all steps in resolutions.
• Added procedure for loading bottles across a bank.
• Opening the Instrument for Internal Access and Opening the Door:
Modified procedure.
• Closing the Door: Modified procedure and added warning for safe to
park sensor.
• Shutting Down the Instrument: Changed to rebooting the instrument
and updated procedure.
• Starting Up the Instrument: Removed Important note. Added note
about location of power cord and switch.
• Unjamming the Robot: Added notes.
• Added Exporting Audit Trail Reports and Saving to an External Drive
Performing System Maintenance

• Modified Rebooting the Instrument section and added rebooting PC
section.
• Removed Setting the Instrument Firmware Language.
Technical • Disinfection Procedure for Spills In the Instrument: Modified note on
change rack removal. Removed note about mycobacterial spills and added
note about tuberculocide disinfecting agents.
• Cleaning the Robot Gripper Pads: Removed note about
mycobacterial spills.
• Cleaning the Conveyor: Removed note about mycobacterial spills.
Technical
Glossary: Added term bank
change
Introduction
Administrative • Changed wording to specify uploading and disposal. Removed

"immediate" from sample results.
• 21CFR11: Modified last sentence in section for clarification.
System Overview
Administrative • Instrument Configuration: Changed wording about racks.

• Text Entry Field: Added word external to barcode scanner important
note.
Release Part
Date Number
Basic Functions:
• Zone 1: Removed navigation from table title.
Administrative • Searching by the Load Status: Added clarification to load and unload
status.
• Processing Expired Bottles: Removed second duplicate note.
• Configuring General Software Settings: Made minor changes to
Administrative defining pattern bullet and Enabling Barcodes on Bottles and Defining
Validation Patterns to add Patient ID.
• Moved introductory text on configuration after user management
section.
Troubleshooting:
Administrative • Changed troubleshooting table into 4 separate tables. Added error
code numbers.
2014-03 414998-EN N/A First publication

bioMérieux, Inc.
100 Rodolphe Street
Durham, North Carolina 27712 USA
EC REP bioMérieux SA
376 Chemin de l'Orme 69280 Marcy-l’Etoile - France
673 620 399 RCS LYON
Tel. 33 (0)4 78 87 20 00 Fax 33 (0)4 78 87 20 90

Virtuo Ingles

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Introduction to the System.....................................................................................1-1

System Overview.................................................................................................... 3-1

System Installation and Setup............................................................................... 4-1

Basic Functions...................................................................................................... 5-1

050574-02 i BACT/ALERT® VIRTUO®

Applying a Barcode Label to a Bottle...........................................................................5-6

050574-02 ii BACT/ALERT® VIRTUO®

Defining User Identification Data.....................................................................6-24

Emergency Manual Bottle Loading and Unloading............................................. 7-1

Best Practices for Preventing False Positives..................................................... 9-1

Performing System Maintenance........................................................................ 10-1

050574-02 iii BACT/ALERT® VIRTUO®

Configuring the Backup..............................................................................................10-4

050574-02 iv BACT/ALERT® VIRTUO®

Warning and Safety Messages

CAUTION: A Caution statement alerts the user to the possibility of a problem

Note: A Note statement supplies additional information about a topic.

BIOMERIEUX, the BIOMERIEUX logo, BACT/ALERT, VIRTUO, MYLA, MAESTRIA, and

Intended Use and Users

050574-02 1-1 BACT/ALERT® VIRTUO®

CAUTION: BACT/ALERT® VIRTUO® is marketed for use in the detection of

The BACT/ALERT® VIRTUO® instrument is a continuous monitoring blood culture system.

050574-02 1-2 BACT/ALERT® VIRTUO®

050574-02 1-3 BACT/ALERT® VIRTUO®

050574-02 1-4 BACT/ALERT® VIRTUO®

IMPORTANT: It is important to follow all the restrictions on use, particularly concerning

Compliance with US and Canadian

050574-02 1-5 BACT/ALERT® VIRTUO®

Compliance with China RoHS

In Vitro Diagnostic Medical Device Batch code

Authorized Representative in the

Serial number Consult Instructions for Use

Use by date Manufacturer

Date of manufacture This way up

Caution, consult accompanying

Contains sufficient for <n> tests Do not reuse

Keep dry Keep away from light

Fragile, handle with care Humidity limitation

Keep away from magnetic field Temperature limitations

Upper limit of temperature Lower limit of temperature

Sterile Positive control

Negative control Biological risk

Electric shock warning Radiation warning

050574-02 1-6 BACT/ALERT® VIRTUO®

Hot surface Potential pinch-point warning

Laser beam Shearing hazard

High temperature Hazardous magnetic field

Potential tip-over/crush hazard Acute toxicity

Corrosives Sodium azide

Environmentally friendly use period.

Fuse Direct current

Alternating current Both direct and alternating current

Three-phase alternating current Earth (ground) terminal

Protective conductor terminal Frame or chassis terminal

050574-02 1-7 BACT/ALERT® VIRTUO®

ON (only for a component of the

Equipment protected throughout by

050574-02 1-8 BACT/ALERT® VIRTUO®

CAUTION: Use of this instrument in a dry environment, especially if synthetic

050574-02 2-1 BACT/ALERT® VIRTUO®

050574-02 2-2 BACT/ALERT® VIRTUO®

Figure 1: Electrical Grounding Requirements