VITEK® DENSICHEK® User Manual

®
VITEK DENSICHEK
®
048641-02 - en - 2022-02
User Manual
EN
IVD
Table of Contents
Introduction to the System.....................................................................................1-1
Intended Use and Users.............................................................................................. 1-1
Intended Use.....................................................................................................1-1
Intended Users and Environments....................................................................1-1
Benefits and Limitations of Use................................................................................... 1-1
Warning and Safety Messages.................................................................................... 1-2
Statement Types............................................................................................... 1-3
General Statements..................................................................................................... 1-3
Standard Symbols........................................................................................................1-6
Safety Information...................................................................................................2-1
System Compliance..................................................................................................... 2-1
Instrument Labels........................................................................................................ 2-1
Safety Precautions.......................................................................................................2-4
System Description and Basic Operations...........................................................3-1
System Description...................................................................................................... 3-1
Reagents......................................................................................................................3-2
List of Components...................................................................................................... 3-2
List of Accessories....................................................................................................... 3-2
List of Consumables.................................................................................................... 3-3
Technical Data and Specifications............................................................................... 3-3
Dimensions....................................................................................................... 3-3
Weight............................................................................................................... 3-4
Electrical Specifications.................................................................................... 3-4
Radio Specifications..........................................................................................3-5
Environmental Conditions................................................................................. 3-5
Computer Specifications................................................................................... 3-6
System Basics............................................................................................................. 3-6
Overview of Operation Elements...................................................................... 3-7
Graphical User Interface................................................................................. 3-11
System Installation and Configuration................................................................. 4-1
Unpacking the Instrument............................................................................................ 4-1
Connecting the Device.................................................................................................4-1
Charging the Pod.............................................................................................. 4-4
Pairing a Pod with a Base................................................................................. 4-4
Configuring the Display Base Settings..............................................................4-4
Configure VITEK® FLEXPREP™ with the Instrument..................................................4-6
Downloading and Installing the DENSICHEK® Communication Bridge............4-6
Configuring the DENSICHEK® Certificates in VITEK® FLEXPREP™.............. 4-8
Configuring the Connectivity Base Settings.................................................... 4-10
User Management...........................................................................................4-11
Workflow and Instructional Procedures............................................................... 5-1
Starting the System......................................................................................................5-1
Shutting Down the System...........................................................................................5-1
Understand McFarland Reference Ranges................................................................. 5-1
Performing McFarland Reference Checks........................................................ 5-3
Zeroing Saline-Filled Test Tube................................................................................... 5-5
Prepare Suspensions...................................................................................................5-6
Standalone Workflow (Display Base only)................................................................... 5-8
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VITEK® DENSICHEK®
Table of Contents
Preparing Suspensions for ID and AST Cards (Standalone)............................ 5-8
Connectivity Workflow (Connectivity Base or Display Base)..................................... 5-10
Logging in to the VITEK® FLEXPREP™ Software.......................................... 5-10
Navigating the VITEK® FLEXPREP™ Software..............................................5-10
Preparing Suspensions for ID and AST Cards (Connectivity).........................5-12
Entering Multiple McFarland Values at Once..................................................5-14
Preparing a QC Suspension in Quality Control Mode.....................................5-15
Updating Firmware..........................................................................................5-15
User Maintenance................................................................................................... 6-1
Required Tools............................................................................................................. 6-1
Calibration and Adjustments........................................................................................ 6-1
Preventive Maintenance Operations............................................................................6-1
Cleaning Procedures................................................................................................... 6-1
Decontamination Procedures.......................................................................................6-3
Appendix - Maintenance Records.........................................................................A-1
Maintenance Schedule................................................................................................ A-1
Maintenance Checklist................................................................................................ A-1
Appendix - Troubleshooting..................................................................................B-1
Error Messages and Recovery Procedures.................................................................B-1
Appendix - Third-Party Software...........................................................................C-1
Appendix - Glossary...............................................................................................D-1
Connectivity Base........................................................................................................D-1
Connectivity Workflow................................................................................................. D-1
Display Base............................................................................................................... D-1
McFarland References................................................................................................ D-1
McFarland Reference Check.......................................................................................D-1
Pod.............................................................................................................................. D-1
Standalone Workflow.................................................................................................. D-1
Revision History
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VITEK® DENSICHEK®
General Information
The content of this document is based on the VITEK® 2 Systems software release 9.01 or
higher.
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).
IMPORTANT: VITEK® DENSICHEK® is a new device and this user manual is not referring to previous
instrument models, such as the DENSICHEK® Plus.
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.
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).
Intellectual Property
BIOMÉRIEUX, the BIOMÉRIEUX logo, VITEK, DENSICHEK, and FLEXPREP 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.
© 2022 bioMérieux, Inc. All rights reserved
Compliance Statements
FCC Compliance (Part 15.19(a)(3))
CAUTION: Changes or modifications not expressly approved could void your authority to use
this equipment. This device complies with Part 15 of the FCC Rules. Operation to the
following two conditions:
1.
2.
This device may not cause harmful interference, and
This device must accept any interference received, including interference that may
cause undesired operation.
Per FCC Part 2.925 (f), a radio with the following FCC ID: 2AQJ2-VTK01 and T9JRN4020 is
included as an operational function of this product.
Industry Canada (IC) Compliance
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1.
2.
This device may not cause interference, and
This device must accept any interference, including interference that may cause
undesired operation of the device.
Conformité Industrie Canada (IC)
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes :
1.
2.
l'appareil ne doit pas produire de brouillage, et
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre le fonctionnement.
FCC and IC Identifiers
The following are applicable to the Pod and the base units:
•
•
Contains FCC ID: T9JRN4020
Contains IC: 6514A-RN4020
The following are also applicable to the Pod:
•
•
FCC ID: 2AQJ2-VTK01
IC: 24083-VTK01
1
Introduction to the System
Intended Use and Users
The VITEK® DENSICHEK® instrument measures the optical density of a microorganism
suspension in 0.45-0.50% saline.
Related Links
Graphical User Interface
Display Base Screen
VITEK FLEXPREP Software Interface Screen
Intended Use
The VITEK® DENSICHEK® instrument is an accessory intended for use with the VITEK® 2
Systems to measure the optical density of a microorganism suspension. The instrument
provides values in McFarland units, proportional to the microorganism concentrations.
VITEK® DENSICHEK® is intended for use with polystyrene tubes, and the reading range is
0.00 to 4.00 McFarland. The VITEK® DENSICHEK® has applications as an in vitro diagnostic
medical device, or in an industry setting.
Intended Users and Environments
The VITEK® DENSICHEK® instrument is intended for professional use by laboratory health
professionals (ex. Microbiology Laboratory Technologists) in clinical or industry settings. The
VITEK® DENSICHEK® can be used to prepare suspensions for testing with VITEK® 2
automated ID/AST system. Though the reading range may be 0.00 to 4.00 McFarland, the
acceptable McFarland ranges vary for specific card types. Refer to the User Interface section
for more information.
The VITEK® DENSICHEK® operates in the same use environments as specified for the
VITEK® 2 Systems.
The instrument is intended for the following specified users and environments:
•
•
•
•
•
The instrument can be used in a large, medium, and small hospital and in private or
industry laboratories for daily processing of a few to several hundred specimens.
The instrument can help users create a standardized test suspension.
The instrument can be used by intended users without risk of shock or injury during use.
The instrument can be used as a portable device on a sample preparation bench.
The instrument can be used in a biosafety cabinet, if required by standard operating
procedures at the customer’s laboratory.
Benefits and Limitations of Use
Benefits and limitations of using the VITEK® DENSICHEK® instrument include the following:
•
•
•
048641-02
The instrument provides accurate digital readings reported in McFarland units (i.e.,
estimates the number of organisms in a suspension by measuring the turbidity of the fluid).
The instrument works with clean 12 mm x 75 mm polystyrene test tubes that are clear,
colorless, and free of scratches.
The instrument is not intended for use with glass test tubes.
1-1
VITEK® DENSICHEK®
Warning and Safety Messages
•
•
•
•
•
•
•
Note:
Introduction to the System
The Pod has a minimum of four hours of continuous battery life before it requires a charge.
The McFarland References provide a way to verify the performance of the instrument.
The instrument automatically enters Power Save mode when a test tube is not inserted
into the Pod after the configured amount of time.
The Pod and the base can be cleaned and disinfected.
The instrument is not intended for use with test tubes that contain seams in the optical
path of the Pod.
The base unit can connect to the VITEK® 2 Systems PC to transmit information via USB if
the user has the compatible software.
The instrument is compatible with VITEK® 2 ID/AST cards and should be used to ensure
suspensions are within an acceptable range. Suspensions outside of an appropriate range
can compromise card performance.
Any information that refers to VITEK® 2 Systems PCs is limited to use with the VITEK® 2
Systems software that is compatible with the VITEK® DENSICHEK® (ex. 9.01 software or
later). If this software is not available to the user, then this information is not applicable.
Figure 1: Optical Path Area
1.
2.
No seams, scratches, or imperfections are allowed in this optical path area
Bottom of the test tube
Figure 2: Test Tube Optical Safe Zone
1.
Optical Safe Zone - Label and marking applied here
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.
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VITEK® DENSICHEK®
Statement Types
Introduction to the System
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:
Note:
An Important statement relates to content presented in the user documentation. It is
used to reinforce the user’s understanding of selected information.
A Note statement supplies additional information about a topic.
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.
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VITEK® DENSICHEK®
General Statements
Introduction to the System
WARNING
Electromagnetic Compatibility (EMC):
The EMC class of the equipment is indicated on the certificate supplied with
it.
If equipment is a class B 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.
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.
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VITEK® DENSICHEK®
General Statements
Introduction to the System
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.
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.
WARNING
Electrical or other connections should only be made using the accessories
supplied with the equipment.
IMPORTANT:
048641-02
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.
1-5
VITEK® DENSICHEK®
Standard Symbols
Introduction to the System
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.
WARNING
Use of other devices, including those that comply with CISPR
emission requirements, could interefere with the instrument's performance.
Standard Symbols
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CE-Marking of Conformity
Compliance with US and Canadian
Safety Standards certified by CSA
Compliance with China RoHS
Regulation (Chinese Standard SJ/
T11364)
UL Listed to US and Canadian Safety
Standards
In Vitro Diagnostic Medical Device
Batch code
Authorized Representative in the
European Community
Catalogue number
Serial number
Consult Instructions for Use
Use by date
Manufacturer
Date of manufacture
This way up
Do not stack
Caution, consult accompanying
documents
Contains sufficient for <n> tests
Do not reuse
1-6
VITEK® DENSICHEK®
Standard Symbols
048641-02
Introduction to the System
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
1-7
VITEK® DENSICHEK®
Standard Symbols
Introduction to the System
Corrosives
Sodium azide
Irritant
Recyclable
Separate collection for waste electrical
and electronic equipment
Environmentally friendly use period.
Actual number of years may vary by
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)
OFF (supply)
ON (only for a component of the
system equipment)
OFF (only for a component of the
system equipment)
Equipment protected throughout by
double insulation or reinforced
insulation (Equivalent to Class II of IEC
536)
Ethernet port
Regulatory Compliance Mark (RCM)
for Electrical Quipment Safety System
(EESS) from the Electrical Regulatory
Authorities Counsil (ERAC) in Australia
For US Only - Caution: US Federal
Law restricts this device to sale by or
on the order of a licensed practitioner
048641-02
1-8
VITEK® DENSICHEK®
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
This IVD instrument complies with the emissions and immunity requirements of IEC 61326.
This instrument complies with:
Base Standard(s): IEC 61010-1:2010 (Third Edition)
Additional Standard(s): IEC 61010-2-101: 2015 (Second Edition)
This is a Class B device per FCC 47CFR Subpart 15 and CISPR11.
Instrument Labels
The VITEK® DENSICHEK® instrument has labels on parts of the instrument to provide
information and to make the user aware of potential hazards. Be familiar with the location and
meaning of the labels on the instrument. There is an instrument label on the bottom of the
Pod component and on the bottom of the base component. The labels contain the serial
number (SN), voltage information, reference number, and other information specific to the
device..
A user interface screen on the Display Base is located on the front of the instrument and
provides functions to operate the VITEK® DENSICHEK® instrument. The Pod contains a
biohazard symbol to inform the user about biological risks.
The instrument requires McFarland References to verify the instrument performance after
receiving it, before its first use, at least on a monthly basis, after cleaning the device, and after
relocating the instrument to a new lab environment.. There are four plastic dual-vial test tube
McFarland References located inside the plastic container. Each reference is identified by a
McFarland value: 0.0 (blank), 0.5, 2.0, and 3.0. The McFarland References have an outer
container label that includes the part number of the McFarland Reference (REF), the date of
manufacture, and the lot number (LOT).
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2-1
VITEK® DENSICHEK®
Instrument Labels
Safety Information
Figure 3: Biohazard Label on the Pod (Overhead View of the Pod)
On each McFarland Reference, you can view the legal manufacturer (bioMérieux), the
product name (VITEK® DENSICHEK®), the LOT number, and the McFarland Reference Value
label. An RFID tag is in the bottom of the vial displaying the legal manufacturer, product
name, and McFarland Reference Value.
Figure 4: Labels for McFarland Reference Test Tubes - McFarland Value View
048641-02
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VITEK® DENSICHEK®
Instrument Labels
Safety Information
Figure 5: Labels for McFarland Reference Test Tubes - Side View
Figure 6: Instrument Label Example- Charging Base
Figure 7: Instrument Label Example- Pod
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VITEK® DENSICHEK®
Safety Precautions
Safety Information
Figure 8: Instrument Label Example - Display Base
Figure 9: Instrument Label Example - McFarland References
Figure 10: Instrument Label Example - UDI (Intended for the Pod and Base Units)
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.
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VITEK® DENSICHEK®
Safety Precautions
Safety Information
WARNING
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
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
Electronic equipment can be the source of electrical shocks. Installation,
service, and repair should only be performed by authorized and qualified
bioMérieux personnel.
WARNING
Cleaning and disinfecting solutions have corrosive properties. Always wear
protective (chemical resistant) gloves and safety glasses when handling
cleaning and disinfecting solutions.
WARNING
Any liquid spilled on the system may result in system malfunctioning. If
liquid is spilled on the system, wipe it up immediately.
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:
048641-02
Before performing electrical safety or other compliance testing on the instrument, contact
bioMérieux or your local distributor.
2-5
VITEK® DENSICHEK®
Safety Precautions
Safety Information
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-less 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
Handle all materials 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.
Ensure that appropriate decontamination is carried out if hazardous
materials are spilled on or into the equipment or surrounding areas.
WARNING
You must follow the storage and/or transport temperature specifications
indicated in this user manual. Failure to do so, may cause the device to
malfunction.
WARNING
Other wireless equipment that complies with CISPR8 emission requirements
could interfere with the medical device or device system.
048641-02
2-6
VITEK® DENSICHEK®
3
System Description and Basic Operations
System Description
The VITEK® DENSICHEK® instrument measures microorganism suspensions for AST and ID
testing in support of VITEK® 2 Systems. It measures the McFarland value of a suspension
prepared in 0.45-0.50% saline in a polystyrene test tube.
The VITEK® DENSICHEK® instrument contains a base unit with a detachable optical
interface, the Pod. With the Pod, the user can visually examine samples with optical readings
that are transmitted automatically to the base unit and to the VITEK® 2 software, which allows
a user to trace the McFarland values for each specimen prepared.
Note:
The optical readings are sent to the VITEK® 2 software only if the user has the VITEK® 2
software compatible with the VITEK® DENSICHEK® (ex. 9.01 software or later), and has
configured it to do so.
The VITEK® DENSICHEK® instrument has the following features:
•
•
•
•
•
•
•
•
•
•
Uses updated optical technologies to determine the turbidity of a suspension, while also
continues to support the current McFarland range for VITEK® 2 ID and AST cards and 12
mm x 75 mm test tubes.
Senses turbidity of suspensions, and provides synergy with the new VITEK® product
family.
Measures across the reading range of 0.20–1.00 McFarland, accurate in the reading
range of 0.20 - 1.00 to within +/-0.11 McFarland, when referenced to a calibrated
spectrophotometer reading at 635 nm using a reference of E. coli (ATCC® 25922).
Measures across the reading range of 1.01–4.00 McFarland, accurate to within +/-(6.5%
+0.06) McFarland, when referenced to a calibrated spectrophotometer reading at 635 nm
using a reference of E. coli (ATCC® 25922).
Reads and displays McFarland readings within two seconds of insertion of a tube, without
requiring any additions, modifications, or calibration adjustments by the operator (in
normal operation).
Is a handheld, portable accessory for the VITEK® 2 automated ID/AST system.
Provides an easier way to create a standardized microorganism suspension for improved
efficiency in setting up VITEK® 2 ID test cards.
Contains a rechargeable battery.
Is available for use 24 hours a day and seven days per week.
Assists the Laboratory Technologist in easily and accurately preparing a standardized
McFarland microorganism suspension.
The instrument is intended for use with pure microorganism cultures. The VITEK®
DENSICHEK® instrument is capable of measuring organism suspensions created from the
following specimen types:
•
•
048641-02
Clinical Specimen
Industry Specimen - Water, air, food samples.
3-1
VITEK® DENSICHEK®
Reagents
System Description and Basic Operations
Figure 11: Task Workflow Overview
Reagents
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
List of Components
•
•
•
•
VITEK® DENSICHEK® McFarland References Kit
VITEK® DENSICHEK® Pod (IVD)
Single USB 2.0 to micro-USB Cable (Included with each Connectivity Base)
Dual USB 2.0 USB connector to micro-USB Cable, single USB 2.0 to micro-USB Cable,
and A/C Power Adapter (Included with each Display Base)
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
List of Accessories
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
•
•
048641-02
VITEK® DENSICHEK® Display Base
VITEK® DENSICHEK® Connectivity Base (for the VITEK® 2 software compatible with the
DENSICHEK® users)
3-2
VITEK® DENSICHEK®
List of Consumables
System Description and Basic Operations
List of Consumables
•
12 x 75 mm Polystyrene Test Tubes
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
Materials that are required, but not provided with the device include:
•
•
•
Sterile saline (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
Loops, sterile sticks, or swabs
Appropriate agar medium (See the Culture Requirements Table.)
Optional accessories include:
•
•
Pre-dispensed saline test tubes (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
Test tube caps
Technical Data and Specifications
The VITEK® DENSICHEK® must be used on a flat, horizontal surface and operated in an area
free of dust.
Dimensions
Table 1: VITEK® DENSICHEK® Pod Dimensions
Parameter
Characteristics
Length
76.5 mm
Width
76.5 mm
Height
79.9 mm
Table 2: VITEK® DENSICHEK® Display Base Dimensions
Parameter
Characteristics
Length
121.6 mm
Width
175.0 mm
Height
59.8 mm
Table 3: VITEK® DENSICHEK® McFarland Reference Kit (with Casing) Dimensions
048641-02
Parameter
Characteristics
Length
120.0 mm
Width
102.0 mm
Height
35.2 mm
3-3
VITEK® DENSICHEK®
System Description and Basic Operations
Table 4: VITEK® DENSICHEK® Connectivity Base Dimensions
Parameter
Characteristics
Length
95.6 mm
Width
98.0 mm
Height
22.3 mm
Weight
Table 5: VITEK® DENSICHEK® Pod Weight
Parameter
Characteristics
Weight
0.2 lbs/0.09 kg
Table 6: VITEK® DENSICHEK® Display Base Weight
Parameter
Characteristics
Weight
0.6 lbs/0.27 kg
Table 7: VITEK® DENSICHEK® McFarland Reference Kit (with Packaging) Weight
Parameter
Characteristics
Weight
0.21 lbs/0.10 kg
Table 8: VITEK® DENSICHEK® Connectivity Base Weight
Parameter
Characteristics
Weight
0.2 lbs/0.09 kg
Electrical Specifications
Mains Supply
The VITEK® DENSICHEK® Display Base instrumentmay be powered directly with the
customer facility's Mains Supply. The VITEK® DENSICHEK® Display Base or VITEK®
DENSICHEK® Connectivity Base instrument may be powered indirectly with the customers
USB 2.0 PC.
The USB adapter must follow the specifications identified in the following table:
048641-02
Specification
Value
Voltage
100-240 VAC
Frequency
50-60 Hz
Current
1A
Power
30 Watts
3-4
VITEK® DENSICHEK®
Radio Specifications
Note:
System Description and Basic Operations
The equipment is designed to be connected to building installations which conform to the
IEC 60364 standard.
The USB cable used for the low-voltage connection to the PC must follow the specifications
identified in the following table:
Specification
Value
USB 2.0
5 VDC, 0.5A
Radio Specifications
•
•
Blue-tooth 2.402 – 2.480 GHz (max output 7dBm)
RFID 200 milliwatts per 2 in - (max output 13.56 MHz)
Environmental Conditions
WARNING
You must operate the device within the specified environmental conditions,
including the specific ambient laboratory humidity conditions and the
specified ambient laboratory lighting conditions. Failing to do so, may cause
the device to malfunction.
The instrument is designed to operate indoors.
The instrument is also intended to be placed on top of a lab bench or a flat, horizontal surface
and operated in an area free of dust .
Specification
Value
Pollution degree
2
The device meets the environmental safety requirments defines in clause 1.4 of the standard
IEC 61010-1:2010 (Third Addition) and IEC 61010-2-101:2015 (Second Addition)
Environmental Conditions
Table 9: Temperatures for VITEK® DENSICHEK® Instrument and McFarland References
Specification
Value
Operating temperature
15°C to 30°C
Temperature for storage and during shipping
-20°C to 55°C
Humidity
Table 10: Humidity for VITEK® DENSICHEK® Instrument and McFarland References
048641-02
Specification
Value
Relative humidity
20% to 80% non-condensing
Humidity during storage and transport
20% to 85% non-condensing
3-5
VITEK® DENSICHEK®
Altitude
System Description and Basic Operations
Altitude
Specification
Value
Maximum altitude
2000 m
Specification
Value
In Operating Mode
Sound level is lower than 70 dB
Sound Level
Operating Lighting Conditions
Specification
Value
Maximum Ambient Light in In Operating
Mode
750 Lux
Computer Specifications
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts. Also refer to these user manuals, as well as the
VITEK® FLEXPREP™ User Manual, for information about computer specifications, settings,
material properties, performance, and limitations for use.
System Basics
Communication between the Pod and the base unit is via Bluetooth. While off the base, the
Pod does not charge and the Pod firmware updates cannot start.
When the Pod is placed on the base unit and paired, firmware updates can be completed and
the Pod battery can be charged.
The Pod must be within 10 meters of the base in order for the Bluetooth to function properly. If
the Pod is out of Bluetooth range, then the device fails to pair.
The following figures demonstrate the possible configurations for the device.
Figure 12: VITEK® DENSICHEK® System Configurations - Display Base
048641-02
3-6
VITEK® DENSICHEK®
Overview of Operation Elements
System Description and Basic Operations
The Display Base can be plugged into the wall using the provided single USB 2.0 to microUSB cable (with no connection to the PC), or the Display Base can be plugged into a PC
using the provided dual USB 2.0 Connector to micro-USB.
Overview of Operation Elements
Figure 13: Display Base and Pod Overview
Main Components of the VITEK® DENSICHEK® Instrument
•
•
•
Display Base or Connectivity Base Unit – Syncs to and charges the Pod.
Pod - Optically reads the McFarland value of microorganism suspensions for the user and
communicates the value to the base unit.
McFarland References – Verifies the calibration of the optics contained within the Pod.
These references are dual-vials and labeled 0.0, 0.5, 2.0, and 3.0 McFarland.
Secondary Components of the VITEK® DENSICHEK® Instrument
•
•
12 mm x 75 mm clear polystyrene test tubes.
VITEK® 2 software compatible with the DENSICHEK® - Assists with the following tasks:
◦
◦
Tracks individual McFarland values from the Pod.
Communicates between the Pod, the base unit, and a PC. (The Pod communicates via
a Bluetooth wireless connection to the base unit. The base unit communicates to the
PC running VITEK® FLEXPREP™ software via a USB wired connection.)
Pod
The Pod optically reads the turbidity of a microorganism suspension and sends the
information to the base unit, so the user has an assessment of the suspension. The Pod is
intended to be used with polystyrene test tubes.
Pod Lights
The Pod has two lights on the front: one for the status of the pairing connection to the base
and one for the McFarland status.
The Pairing Light demonstrates connectivity by:
•
•
048641-02
A blinking red light or solid colored light that does not match that of the base unit indicates
that the Pod is not synced to the base unit, or it is out of range from the base unit.
A solid colored light matching that of the base unit indicates that the Pod is synced to the
base unit.
3-7
VITEK® DENSICHEK®
Pod
System Description and Basic Operations
Note:
•
•
The solid colored light is configured on the Configuration screen by the user. The color
options are cyan, blue, pink, white, green, and yellow.
No illumination of the light indicates that the Pod is not charged.
A blinking colored light (excluding red) indicates that the Pod entered Power Save mode. If
you want to exit Power Save mode, insert a test tube into the paired Pod, tap the display
screen, or remove and re-seat the Pod on the base unit. The Pod turns on again.
Note: Power Save mode does not affect connected PCs.
The McFarland Status light demonstrates performance by:
•
•
•
•
A green light indicates that the suspension is within the selected card type performance
range.
A red light indicates that the suspension is above the selected card type performance
range.
A yellow light indicates that the suspension is below the selected card type performance
range.
No light indicates that a suspension is being measured with the N/A card selected, that the
pod is in the process of taking a McFarland measurement, or that no measurement is in
progress.
Note: When you have selected the N/A screen, the system does not alert you when a
suspension is in or out of range. N/A provides the McFarland value for suspensions, but it
does not provide an acceptable range.
Pod Button
The Pod has one button on the back of it. If the Pod is paired with a base and a test tube is
inserted, when this button is pressed once, the McFarland value for the current suspension is
captured on the VITEK® FLEXPREP™ screen (if configured).
IMPORTANT: After pressing the button on the Pod, the following happens: The saved McFarland
value appears above the main number on the screen.
If the button is held down for approximately three seconds after the reading period has ended,
and, while a saline tube or 0.0 McFarland reference is inserted, the pod enters zeroing mode.
Figure 14: Pod
048641-02
3-8
VITEK® DENSICHEK®
Display Base
System Description and Basic Operations
1.
2.
3.
McFarland Status Light
Pod Pairing Light
Pod Button
A contrast plate is included with the Pod. The contrast plate can be used to aid in assessing
the turbidity of a suspension. This contrast plate cannot be used as an alternative manual
inoculation measurement method.
Figure 15: Contrast Plate Within the Pod
1.
Contrast Plate
Display Base
The Display Base syncs to and charges the Pod. This base has a display screen that displays
the McFarland reading measurement of the tube inserted into the Pod. This base can also
transmit information to the VITEK® 2 software compatible with the VITEK® DENSICHEK®, if
the user has access to the software.
When a Pod is synced to a Display Base, the McFarland Status light on the Pod matches the
McFarland Meter color on the display screen. Additionally, the Pod icon color in the corner of
the display screen matches the Pairing Light color on the Pod.
048641-02
3-9
VITEK® DENSICHEK®
Connectivity Base
System Description and Basic Operations
Figure 16: VITEK® DENSICHEK® Display Base with the Pod
1.
2.
McFarland Status Light
Display Screen
Connectivity Base
The Connectivity Base syncs to and charges the Pod. This base unit does not have a display
screen, so the values are transmitted directly to the VITEK® FLEXPREP™ software.
Both the Display Base and the Connectivity Base work with the Connectivity workflows;
however, the connectivity base does not work with Standalone workflows. To use the
Connectivity Base, you must have the instrument connected to the compatible PC with
VITEK® FLEXPREP™ software using the provided USB cable.
When a Pod is synced to a Connectivity Base, the Pod Pairing Light color matches the Base
Pairing Light color.
WARNING
If the Connectivity Base fails to communicate with the PC, the following
occurs: (1) the McFarland measurement data is not displayed; (2) the
Connectivity Base cannot download software or firmware updates; and (3)
the Connectivity Base cannot send data to the connected VITEK® 2 Systems
PC.
Figure 17: VITEK® DENSICHEK® Connectivity Base with the Pod
048641-02
3-10
VITEK® DENSICHEK®
Graphical User Interface
1.
2.
3.
4.
5.
System Description and Basic Operations
McFarland Status Light
Pod Pairing Light
Base Pairing Light
Pod Button
Base Charging Port
Graphical User Interface
With the graphical user interface of the VITEK® DENSICHEK®, you can easily identify and
capture the McFarland value of your suspension. When using the Display Base, the graphical
user interface is on the instrument in the form of a display screen, and, if configured, a
software interface called FLEXPREP. When using a Connectivity base, the graphical user
interface is with the FLEXPREP software interface.
Display Base Screen
On the Display Base touch screen, users can tap the Card Type button on the bottom of the
display to select the appropriate card type (GN-GP, BCL-YST, ANC-CBC-NH, or N/A), or
users can tap the Configuration button to view or alter the instrument configuration settings.
Figure 18: VITEK® DENSICHEK® Display Base
1.
2.
3.
4.
5.
6.
7.
Configuration button
McFarland Range Meter
Card Type button
Pod Battery Life icon
Pod Pairing Color icon
McFarland Value (Example:0.53 McFarland Reading)
PC Connection icon
This screen is applicable for all suspension types (ex. GN, GP, ANC, etc.)
The display screen offers unique reading ranges for each of the following screen views:
•
•
•
•
048641-02
GN - GP
BCL - YST
ANC - CBC - NH
N/A
3-11
VITEK® DENSICHEK®
Display Base Screen
System Description and Basic Operations
Table 11: VITEK® DENSICHEK® Display Base Symbols and Screens
Symbol or Screen
Description
Pod Battery Life icon - Pod not charging
Pod Battery Life icon - Pod needs to be
charged
Pod Battery Life icon - Pod is charging
Configuration button - Base and Pod pairing
settings and more
PC Connection icon - Base connected to
and communicating with the PC
Home button - McFarland screen access
Left (decrease) Arrow button
Right (increase) Arrow button
Pod Pairing Color button
Display Brightness button
Base Sleep Time button (to enter Power
Save mode)
Tube Light Intensity button
Pod Pairing Color buttons - Pod pairing
color options
Configuration screen
048641-02
3-12
VITEK® DENSICHEK®
Display Base Screen
System Description and Basic Operations
Symbol or Screen
Description
Welcome screen
McFarland screen
Update screen - Pod firmware update is
occurring
McFarland Reference screen - A McFarland
Reference is inserted in the Pod (LOT
number value appears)
McFarland screen - Card type is locked by
VITEK® FLEXPREP™ (Card type selected
from McFarland meter in VITEK®
FLEXPREP™)
McFarland screen - No tube is inserted
048641-02
3-13
VITEK® DENSICHEK®
VITEK® FLEXPREP™ Software Interface Screen
System Description and Basic Operations
Symbol or Screen
Description
McFarland screen - Tube is inserted into
Pod, and Pod is zeroed
McFarland screen - McFarland value is
captured
IMPORTANT: After pressing the button on
the Pod, the following happens: The
saved McFarland value appears above the
main number on the screen.
VITEK® FLEXPREP™ Software Interface Screen
The software interface of the VITEK® 2 software is compatible with the VITEK® DENSICHEK®
and mimics the look of the Display Base screen.
The software offers the following features when the VITEK® DENSICHEK® Display Base or
Connectivity base is connected to a VITEK® FLEXPREP™ PC:
•
•
•
•
•
•
048641-02
VITEK® FLEXPREP™ software mimics the VITEK® DENSICHEK® Display Base, including
configuration settings. (Display Base configuration is only performed on the device.)
The DENSICHEK Gauge window appears on the PC when the instrument is actively
being used (i.e., a tube is inserted ) with FLEXPREP on 'Quick McFarland Entry' window,
or 'Defining the Cassette' window.
Pressing the button on the VITEK® DENSICHEK® sends the McFarland value to the PC.
VITEK® FLEXPREP™ only saves the value if it is configured to use a VITEK®
DENSICHEK®.
The following information appears on the connected PC:
◦ McFarland Value
◦ DENSICHEK Gauge window with McFarland Range
◦ LOT Number (with the McFarland Reference inserted in the Pod)
The PC Connection icon appears on the Display Base screen of the VITEK®
DENSICHEK® when the instrument is communicating with the connected PC.
The PC displays the McFarland meter range based on card type. The card type is locked
on the base when a card type selection is made within VITEK® FLEXPREP™. The card
type and meter range unlock if the connection is lost, or if the isolate is validated or
cancelled in VITEK® FLEXPREP™.
3-14
VITEK® DENSICHEK®
VITEK® FLEXPREP™ Software Interface Screen
System Description and Basic Operations
Figure 19: VITEK® FLEXPREP™ with VITEK® DENSICHEK® - Locked Card Type on
Display Base
Figure 20: Configuration Screen
1.
2.
3.
Application Configuration section
VITEK® 2 Configuration section
McFarland Reference Standard button
Figure 21: Quick McFarland Entry Screen
048641-02
3-15
VITEK® DENSICHEK®
VITEK® FLEXPREP™ Software Interface Screen
1.
2.
3.
4.
5.
System Description and Basic Operations
Quick McFarland Entry button
McFarland field
Isolate field
Lab ID field
Row Number
Figure 22: Cassette Identification Screen
1.
2.
3.
4.
5.
6.
7.
8.
9.
048641-02
Lab ID and Isolate fields
VITEK® 2 PC field
Cassette ID field
User Account
Full Screen button
Cancel button
Validate button
Quick McFarland Entry button
Layout button
3-16
VITEK® DENSICHEK®
VITEK® FLEXPREP™ Software Interface Screen
System Description and Basic Operations
Figure 23: Cassette Definition Screen
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
048641-02
Lab ID and Isolate fields
Abbreviated Summary view
User Account
Full Screen button
Full Summary button
Send Cassette button
Cancel button
Validate button
McFarland Entries button
Card Navigation buttons
Delete Card button
Add Card button
New Cassette button
Card Fields
QC (Quality Control) button (disabled)
Layout button
3-17
VITEK® DENSICHEK®
VITEK® FLEXPREP™ Software Interface Screen
System Description and Basic Operations
Figure 24: Quality Control Screen
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Lab ID and Isolate fields
Abbreviated Summary view
User Account
Full Screen button
Full Summary button
Send Cassette button
Cancel button
Validate button
McFarland Entries button
Card Navigation buttons
Delete Card button
Add Card button
New Cassette button
Card Fields
QC (Quality Control) button (enabled)
Layout button
Figure 25: Cassette Definition Screen with Test Cards
048641-02
3-18
VITEK® DENSICHEK®
System Description and Basic Operations
Figure 26: Configuration Screen - Connectivity Base Configuration Section
Performance Ranges
Suspensions for specific cards (ex. GN - GP) must fall within the correct performance ranges.
There are unique screen views with specific ranges for different types of cards. The
McFarland reading ranges are as follows:
Table 12: Display Screens and Corresponding Ranges
Display Screen
Displayed Reading Ranges
Performance Ranges
GN - GP
0.00 - 2.00
0.50 - 0.63
YST- BCL
0.00 - 4.00
1.80 - 2.20
CBC - NH - ANC
0.00 - 4.00
2.70 - 3.30
N/A
0.00 - 4.00
N/A
The McFarland meter on the screen appears green, yellow, or red to relay whether the values
are in or out of range:
•
•
•
•
If no organism suspension is inserted, the meter appears gray.
If the organism suspension has a McFarland value that is above the defined performance
range for the selected card type, the meter appears red.
If the organism suspension has a McFarland value that is below the defined performance
range for the selected card type, the meter appears yellow.
If the organism suspension has a McFarland value that is within the defined performance
range for the selected card type, the meter appears green.
Related Links
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
GN and GP
The GN - GP screen shows a McFarland range of 0.00 to 2.00. The GN and GP suspensions
must fall within the 0.50 and 0.63 range to show an appropriate McFarland reading.
Figure 27: VITEK® DENSICHEK® Display Base Screen - GN and GP
048641-02
3-19
VITEK® DENSICHEK®
YST and BCL
System Description and Basic Operations
YST and BCL
The YST - BCL screen shows a McFarland range of 0.00 to 4.00. The YST and BCL
suspensions must fall within the 1.80 and 2.20 range to show an appropriate McFarland
reading.
Figure 28: VITEK® DENSICHEK® Display Base Screen - YST and BCL
CBC, NH, and ANC
The CBC - NH - ANC screen shows a McFarland range of 0.00 to 4.00. The CBC, NH, and
ANC suspensions must fall within the 2.70 and 3.30 range to show an appropriate McFarland
reading.
Figure 29: VITEK® DENSICHEK® Display Base Screen - CBC, NH, and ANC
N/A
The N/A screen shows a McFarland range of 0.00 to 4.00.
When you have selected the N/A screen, the system does not alert you when a suspension is
in or out of range. N/A provides the McFarland value for suspensions, but it does not provide
an acceptable range.
Figure 30: VITEK® DENSICHEK® Display Base Screen - N/A
048641-02
3-20
VITEK® DENSICHEK®
4
System Installation and Configuration
Unpacking the Instrument
1.
2.
3.
4.
Inspect the shipping container for external damage.
Open the shipping carton, and then remove the instrument from the shipping carton.
Carefully remove the instrument from the plastic bag.
Remove the remaining parts and documentation from the carton:
•
•
Product Certificates
VITEK® DENSICHEK® Instrument User Manual CD
5. Place the VITEK® DENSICHEK® instrument on a flat, horizontal surface that is dust
free and away from direct sunlight.
WARNING
Failing to follow the proper installation procedures will result in
incorrect device performance.
Connecting the Device
One of two methods may be used to power the Display base. One method is to connect the
Display Base directly to AC power by use of a Single USB 2.0 to micro-USB and the provided
AC Power Adapter. The second is to connect the Display Base to the PC by use of the 2.0
Dual USB connector to micro-USB. Only one method may be used to power the Connectivity
Base. That is by connecting the Connectivity Base to the PC by use of the Single USB 2.0 to
micro-USB .
If the battery life of the Display Base's Pod is completely depleted, it should be recharged on
the Display Base. When doing so, ensure that either power is applied with the provided AC
Power Adapter, or ensure both ends of the Dual USB connector are plugged into a PC.
048641-02
4-1
VITEK® DENSICHEK®
Connecting the Device
System Installation and Configuration
Figure 31: Two USB Connectors Inserted into 2.0 USB ports of PC
Figure 32: Display Base with Cable (2.0 Dual USB connector to micro-USB)
048641-02
4-2
VITEK® DENSICHEK®
Connecting the Device
System Installation and Configuration
Figure 33: 2.0 Dual USB connector to micro-USB
Figure 34: Single USB 2.0 to micro-USB
Figure 35: AC/DC Adapter - Front View
048641-02
4-3
VITEK® DENSICHEK®
Charging the Pod
System Installation and Configuration
Figure 36: AC/DC Adapter - Back View
Related Links
Graphical User Interface
Display Base Screen
VITEK FLEXPREP Software Interface Screen
Charging the Pod
1. Ensure the base is plugged into a power source. (See above: Connecting the Device.)
Note:
To use the instrument, the base unit must have power applied.
2. Place the Pod on the base unit.
The Pod charges while placed on the base unit.The status of the Pod battery life can
be viewed on the Display Base or the VITEK® FLEXPREP™ software.
Note:
The Pod will continue to charge, even if the display of the Display Base is asleep.
Pairing a Pod with a Base
1. Ensure the base unit is plugged into a power source.
A blinking red light on the Pod indicates that the Pod is not synced to the base unit.
2. Place the Pod on the base unit.
Note: No illumination of the light indicates that the Pod is not charged.
Note: If the Pod was previously paired with a base, once the Pod is placed onto the base
unit, the Pod LED stops flashing red and turns the solid pairing color that was
previously configured.
A solid colored light on the Pod matching that of the base indicates that the Pod is
synced to the corresponding base unit.
Configuring the Display Base Settings
Customize your Display Base screen to select LED colors, adjust brightness, and more.
048641-02
4-4
VITEK® DENSICHEK®
Configuring the Display Base Settings
System Installation and Configuration
1. Place the Pod on the Display base unit.
Figure 37: Display Base - McFarland Screen - No tube is inserted
A solid colored light on the Pod matching that of the base unit indicates that the Pod is
synced to the base unit. The Display Base lights up and shows dashes for the
McFarland value.
2.
Tap the Configuration button
.
Figure 38: Configuration Screen
1.
2.
3.
4.
5.
6.
7.
8.
9.
Home button
Left (Decrease) Arrow button
Pod Pairing Color button
Tube Light Intensity button
Display Brightness button
Base Sleep Time button
Selection Indicator
Right (Increase) Arrow button
Firmware Version
The Configuration screen appears.
3. Tap the Pod Pairing Color button, and tap the Left Arrow or Right Arrow buttons to
change the pairing LED color (ex. cyan, blue, pink, white, green, or yellow LED light
options).
4. Tap the Tube Light Intensity button, and tap the Left Arrow button to decrease the
LED brightness, or click the Right Arrow button to increase the LED brightness.
048641-02
4-5
VITEK® DENSICHEK®
Configure VITEK® FLEXPREP™ with the Instrument
System Installation and Configuration
5. Tap the Display Brightness button, and tap the Left Arrow button to decrease the
LCD screen brightness, or click the Right Arrow button to increase the LCD screen
brightness.
6. Tap the Base Sleep Time (min) button, and tap the Left Arrow button to decrease the
amount of time before Power Save mode automatically turns on, or click the Right
Arrow button to increase the amount of time before Power Save mode automatically
turns on.
Note: In the Base Sleep Time configuration screen, the zero setting (far left) disables the
Power Save mode, so the base screen never turns off. The incremental marks
represent 5, 10, 20 and 30 minutes from left to right, which is the amount of time that
must occur before the base unit enters Power Save mode.
7. Tap the Home button to return to the McFarland Reading screen.
Note:
A Pod sitting on the Display Base will continue to charge even when the Display Base
is asleep.
Configure VITEK® FLEXPREP™ with the Instrument
To use the VITEK® FLEXPREP™ software with the VITEK® DENSICHEK® instrument, you
must complete the following configuration tasks:
1.
2.
3.
Downloading and Installing the DENSICHEK® Communication Bridge
Configuring the DENSICHEK® Certificates in VITEK® FLEXPREP™
Downloading and Installing the DENSICHEK® Communication Bridge
These tasks must be completed in the order written before using the VITEK® FLEXPREP™
program with your VITEK® DENSICHEK® instrument.
Note:
These configurations must be completed for every VITEK® 2 System PC and remote PC
accessing VITEK®FLEXPREP™.
Related Links
Graphical User Interface
Display Base Screen
VITEK FLEXPREP Software Interface Screen
Configuring the DENSICHEK Certificates in VITEK FLEXPREP
Downloading and Installing the DENSICHEK Communication Bridge
Downloading and Installing the DENSICHEK® Communication Bridge
1. Ensure the instrument is connected to a VITEK® 2 PC or a remote PC that's accessing
VITEK® FLEXPREP™, and the PC desktop is displayed.
2. Double click the VITEK 2 Systems (legacy) icon on the Desktop.
3. Log in to the system software.
Administrator or Supervisor level login access is required. Refer to the bioMérieux
User Management User Manual for information about accessing, creating and
managing user accounts.
4. When the VITEK® 2 home screen appears, click the Configuration View icon on the
left, and then click General Configuration
The System screen appears.
048641-02
4-6
VITEK® DENSICHEK®
Downloading and Installing the DENSICHEK® Communication
Bridge
System Installation and Configuration
5. Click the Lock/Unlock icon at the top-middle of your screen, and then click Yes to
continue.
6. Click the Settings tab, and then under the Miscellaneous section, select the Enable
McFarland checkbox.
Refer to VITEK® 2 System User Manuals for more user information regarding the
additional setting options.
Note:
Once Enable McFarland is saved, it is configured for all users. You cannot configure
this setting differently for each user from the VITEK® 2 System application. However,
you will configure user settings in FLEXPREP™, as described in the following steps.
7. Click Save.Click the Lock/Unlock icon and then Quit or Close the VITEK® 2 Systems
application.
8. For the VITEK® 2 PC, access VITEK® FLEXPREP™ on the desktop, and then doubleclick the FLEXPREP icon. For a remote PC, access VITEK® FLEXPREP™ by
launching the Firefox® browser. Refer to the VITEK® FLEXPREP™ User Manual for
configuration of VITEK® FLEXPREP™ from a remote PC.
Note:
If Firefox browser states "Your connection is not secure", refer to the VITEK®
FLEXPREP™ User Manual for instructions about adding Exceptions.
The VITEK® FLEXPREP™ program launches in a Firefox browser window.
9. At the bioMérieux Single Sign-On screen, log in with the appropriate lab credentials.
Note:
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts.
To reconfigure your VITEK® FLEXPREP™ settings or certificates, refer to the VITEK®
FLEXPREP™ User Manual.
The VITEK® FLEXPREP™ home screen appears with the Sample Preparation and
Configuration options.
10. Click Configuration, and Display VITEK DENSICHEK, and select Yes for Use VITEK
DENSICHEK.
Note: This configuration must be completed for each VITEK® 2 System user. Once it is
configured, it is only configured for that particular user.
11. Shortly thereafter, the Download DENSICHEK Communication Service window
appears to alert you that installation of the Communication service is needed.
048641-02
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VITEK® DENSICHEK®
Configuring the DENSICHEK® Certificates in VITEK® FLEXPREP™
System Installation and Configuration
Figure 39: Download DENSICHEK Communication Service Window
12. Remove all USB memory devices, CDs, and DVDs.
13. After reading the Communication Service Window instructions, follow step 1 by clicking
the link here. The Opening install-dce-bridge.exe window appears.
14. Click Save File.
15. When the File Explorer appears ensure that Downloads folder is selected, and then
click Save. The file will download into the Downloads folder. The download may take
several minutes to finish.
16. Navigate to the Downloads folder, locate the install-dce-bridge.exe file, and then
double-click it to execute the file installation.
17. If the Open Executable File? warning appears, click OK.
18. If the User Account Control warning appears, click Yes. (This may appear as a
flashing shield in the Windows task bar which you must first click.)
19. Select your corresponding language from the dropdown and click OK.
Note: This Language selection is only for the text display of the InstallAnywhere wizard.
Language options: English, French, German,Italian, Portuguese, Spanish.
20. The DENSICHEK Bridge 1.0 install wizard launches. When the "Congratulations!
DENSICHEK Bridge has been successfully installed" message appears, keep all the
default setting that has "Yes, restart my system" pre-selected, and click Done.
21. If the computer does not restart automatically, restart the computer from the desktop to
complete the install.
Configuring the DENSICHEK® Certificates in VITEK® FLEXPREP™
Note:
This configuration must be completed for every VITEK® 2 System PC and remote PC
accessing VITEK® FLEXPREP™. Once it is configured, it is configured for all users. You
cannot configure these settings differently for each user.
Note:
Administrator or Supervisor level login access is required. Refer to the bioMérieux User
Management User Manual for information about accessing, creating and managing user
accounts.
1. For the VITEK® 2 PC, double-click the FLEXPREP icon. For a remote PC, access
VITEK® FLEXPREP™ by launching the Firefox® browser. Refer to the VITEK®
048641-02
4-8
VITEK® DENSICHEK®
Configuring the DENSICHEK® Certificates in VITEK® FLEXPREP™
System Installation and Configuration
FLEXPREP™ User Manual for configuration of VITEK® FLEXPREP™ from a remote
PC.
The VITEK® FLEXPREP™ program launches in a Firefox browser window.
2. After the software initializes, the bioMérieux Single Sign-On screen appears; log in
with the appropriate lab credentials.
Note:
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts.
To reconfigure your VITEK® FLEXPREP™ settings or certificates, refer to the VITEK®
FLEXPREP™ User Manual. Click Configuration, and Display VITEK DENSICHEK,
and select Yes for Use VITEK DENSICHEK.
Figure 40: Download DENSICHEK Communication Service Window
3. After reading the instructions, follow step 2 by clicking Click Here.
Certificates have to be configured to use the VITEK® DENSICHEK® with VITEK®
FLEXPREP™.Refer to the VITEK® FLEXPREP™ User Manual for information about
handling security exceptions.
A tab appears that states, Your connection is not secure, indicating that certificates
have not been accepted yet.
4. Click Advanced.
Information appears about security certificates.
5. Click Add Exception.
The Add Security Exception window appears.
6. Ensure Permanently store this exception is enabled and click Confirm Security
Exception.
The screen is refreshed, and the version is displayed in the top-left corner.
7. Close the current tab.
The VITEK® FLEXPREP™ screen reappears.
8. In the Download DENSICHEK Communication Service window, click OK.
9. On the Configuration page, select Yes for 'Display VITEK DENSICHEK' to display the
McFarland Meter in the Software during appropriate workflows detailed in 'Workflow
and Instructional Procedures', if desired.
10. Click the Save button, and click OK.
11. Close and re-open VITEK® FLEXPREP™ to refresh the settings.
12. Re-login to VITEK® FLEXPREP™. Reinstall any required USB devices, CDs, DVDs.
048641-02
4-9
VITEK® DENSICHEK®
Configuring the Connectivity Base Settings
System Installation and Configuration
Configuring the Connectivity Base Settings
You can customize your VITEK® DENSICHEK® Connectivity Base settings through VITEK®
FLEXPREP™.
With the compatible VITEK® 2 software, you can customize your screen to select your LED
colors, adjust your brightness, and more on the VITEK® 2 Systems PC by launching the
VITEK® FLEXPREP™ program.
Figure 41: Configuration Settings
Note:
This configuration must be completed for every VITEK® 2 System PC and remote PC
accessing VITEK® FLEXPREP™. Once it is configured, it is configured for all users. You
cannot configure these settings differently for each user.
1. Ensure the instrument is connected to a VITEK® 2 PC or a remote PC that's accessing
VITEK® FLEXPREP™, and the PC desktop is displayed.
2. Place the Pod on the base unit.
A solid colored light matching that of the base unit indicates that the Pod is synced to
the base unit.
3. For the VITEK® 2 PC, access VITEK® FLEXPREP™ on the desktop, and then doubleclick the FLEXPREP icon.
The VITEK® FLEXPREP™ program launches in a Firefox browser window.
4. At the bioMérieux Single Sign-On screen, log in with the appropriate lab credentials.
Note:
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts.
To reconfigure your VITEK® FLEXPREP™ settings or certificates, refer to the VITEK®
FLEXPREP™ User Manual.
The VITEK® FLEXPREP™ home screen appears with the Sample Preparation and
Configuration options.
5. Click Configuration, and navigate to the Connectivity Base Configuration section.
048641-02
4-10
VITEK® DENSICHEK®
User Management
System Installation and Configuration
The Connectivity Base Configuration settings only appear if the VITEK®
DENSICHEK® Communication Bridge is set up in VITEK® FLEXPREP™ and if a
Connectivity Base is connected to the VITEK® 2 PC.
6. For the Pod Color, select a color to change the pairing LED color (ex. cyan, blue, pink,
white, green, or yellow LED light options).
A solid colored light matching that of the base unit indicates that the Pod is synced to
the base unit.
7. For the Tube Light Intensity, click the left/right arrow to decrease/increase the LED
brightness or click the scale to adjust it from 0-100% brightness.
8. For the Base Sleep Time (min), click the left/right arrow to decrease/increase the
amount of time or click the scale to adjust it from 0-30 minutes before the Power Save
mode automatically turns on.
Note:
In the Base Sleep Time configuration screen, the zero setting (far left) disables the
Power Save mode, so the base power never turns off. For the 5-30 minute values, the
value indicates the amount of inactivity time in minutes that must occur before the
base unit and the Pod enters Power Save mode.
9. Click Save.
The Confirmation message appears.
10. Click OK to save the settings.
IMPORTANT:
The contents of your VITEK® 2 cassette is discarded upon saving the
configuration if the cassette has not been sent to the VITEK® 2 server.
The settings have been updated and the pairing color changes.
IMPORTANT:
To complete installation, the user must perform a zeroing with the 0.0
McFarland Reference on each pod. Refer to Performing McFarland Reference
Checks in Chapter 5.
User Management
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts. Refer to these documents for a list of all possible user
groups and rights.
048641-02
4-11
VITEK® DENSICHEK®
5
Workflow and Instructional Procedures
Starting the System
The base unit must be plugged in, and the Pod must be charged by placing it on the base.
Before use, the device is in Power Save mode. The device turns on once a tube is inserted
into the Pod, when the display screen is tapped, or when the Pod is removed and re-seated
onto the base unit.
When the Connectivity Base enters Power Save mode, the base pairing light blinks and the
Pod pairing light blinks. However, if the Pod is on the Connectivity Base when the device
enters Power Save mode, the base light remains on, without blinking.
For instructions to start the VITEK® 2 software and PC compatible with the device, refer to the
VITEK® 2 User Manuals.
Shutting Down the System
After the configured amount of time, the instrument enters Power Save mode. The amount of
time before entering the Power Save mode can be chosen by the user on the Configuration
screen. The default amount of time is five minutes. The device turns on again once a tube is
inserted into the instrument, once the base screen is touched, or when the Pod is removed
and re-seated onto the base unit. When the Display Base enters Power Save mode, the
display screen turns off and the Pod pairing light blinks.
The Pod cannot be turned off. Battery power is depleted over time when it has not been
charged on the base. For instructions to shut down the VITEK® 2 software and PC compatible
with the device, refer to the VITEK® 2 User Manuals.
Note:
The base unit can only be turned off by unplugging it from its power source. The Pod will turn
off when the battery is depleted.
Understand McFarland Reference Ranges
The McFarland References are labeled with values to indicate a target range. When a
McFarland Reference is inserted, a screen similar to the following appears:
048641-02
5-1
VITEK® DENSICHEK®
Understand McFarland Reference Ranges
Workflow and Instructional Procedures
Figure 42: McFarland Reference Screen
1.
2.
3.
McFarland Range Meter
LOT Number (Received from RFID tag)
McFarland Reference Value
The screen is different from the normal McFarland screen, because a LOT number appears.
The McFarland Reference value is recorded in the RFID tag. When performing the reference
check for the 0.5, 2.0 and 3.0 references, the McFarland meter appears green when the
device is reading within the acceptable ranges. Additionally, the McFarland Status light on the
Pod indicates the status of the McFarland Reference--red indicates a failing value and green
indicates a passing value.
This must be confirmed in order for users to determine that the McFarland References and
the device are working properly.
WARNING
: Values for McFarland References in Table 13 are specific to the McFarland
Reference set and must not be used with a different set.
Table 13: Values for McFarland References
048641-02
McFarland Reference
Acceptable Range
Explanation
0.0 McF
N/A
This McFarland Reference
must be used before inserting
a 0.5, 2.0, or 3.0 McFarland
Reference. It is specific to the
McFarland Reference set and
must not be used with a
different set. After completing
the McFarland Reference
checks, you must perform the
Zeroing Saline-Filled Test
Tubes procedure using a test
tube with saline.
0.5 McF
0.39 - 0.61 McF
This value represents the
McFarland value for GP/GN
cards. The value is not
intended to be exact.
5-2
VITEK® DENSICHEK®
Performing McFarland Reference Checks
IMPORTANT:
Workflow and Instructional Procedures
McFarland Reference
Acceptable Range
Explanation
2.0 McF
1.81 - 2.19 McF
This value represents the
McFarland value for
YST/BCL cards. The value is
not intended to be exact.
3.0 McF
2.75 - 3.25 McF
This value represents the
McFarland value for
CBC/NH/ANC cards. The
value is not intended to be
exact.
The RFID tag within each of the McFarland References sends the McFarland
Reference value to the instrument. Use the McFarland meter on the screen to
determine whether the device is reading within the acceptable ranges.
Performing McFarland Reference Checks
If you are using the VITEK® 2 software compatible with VITEK® DENSICHEK®, follow the
Logging in to VITEK® FLEXPREP™ procedure before performing these steps.
Users are expected to perform a McFarland Reference check prior to the first use of the
device, at least once a month, after cleaning the device, and after relocating the instrument to
a new lab environment. The user never calibrates the device. It is calibrated at the
manufacturing site during assembly. The user must perform McFarland Reference checks to
confirm that the device performance is within the acceptable range.
Before use, the device is in Power Save mode. The device turns on once a tube is inserted.
Use the device to perform the McFarland Reference checks and record the McFarland values
that appear on the meter.
WARNING
If you insert a McFarland Reference tube and any of the following issues
occur, then the McFarland Reference or device may be malfunctioning:
•
•
•
•
A McFarland range or McFarland value fails to appear on the screen.
A LOT number fails to appear on the screen.
The tube does not illuminate (if configured to do so).
The McFarland Reference tube is out of range.
Failure to resolve a malfunctioning McFarland Reference or device may lead
to incorrect McFarland results. Contact your bioMérieux representative for
more information.
WARNING
Failure to perform regular McFarland Reference checks could cause
incorrect McFarland readings when creating suspensions. Users must run a
McFarland Reference check once a month to confirm that the device is
reading within the acceptable ranges.
048641-02
5-3
VITEK® DENSICHEK®
Performing McFarland Reference Checks
Workflow and Instructional Procedures
WARNING
If a McFarland Reference tube or a saline-filled test tube with specimen is
smeared, has debris on it, is scratched, or is damaged, do not use it. Using a
dirty or damaged McFarland Reference or test tube can cause incorrect
results.
WARNING
If the McFarland References are free of damage, scratches, and debris, and
the reading is red, then thedevice or the McFarland Reference is not
functioning properly. If the issue persists, contact a local bioMérieux
representative for assistance.
CAUTION: When performing a McFarland Reference check, if the McFarland
reading appears outside an acceptable range for multiple McFarland
References, there may be an issue with your device. Contact a local
bioMérieux representative for assistance.
CAUTION: If the McFarland Reference tube is inserted incorrectly, then the
McFarland Reference value does not appear on the screen.
Note:
DO NOT mix McFarland References between different reference sets.
1. Ensure the test tubes are free of damage, scratches, and debris before use.
2. Optional: If interfaced with the FLEXPREP™ software, navigate to the Configuration
screen within FLEXPREP before inserting the 0.0 McFarland Reference.
3. Insert the 0.0 McFarland Reference into the instrument so that the tube with the
McFarland Reference value faces you and is in the front tube location of the Pod.
The device illuminates the tube and measures the McFarland Reference. Either a
McFarland value or X.XX in red appears on the screen, along with the LOT number of
the McFarland Reference .
4. Press and hold the button on the back of the Pod until the Tube Light flashes and the
two second reading period begins. After the reading period ends, the McFarland value
appears as 0.00 on the screen.
Note:
The Pod McFarland Status Light will remain the color red when zeroing it with the 0.0
McFarland Reference. A 0.00 on the screen indicates the Pod has successfully
zeroed.
The Pod is zeroed.
5. Insert the next McFarland Reference into the instrument.
048641-02
5-4
VITEK® DENSICHEK®
Zeroing Saline-Filled Test Tube
Note:
Workflow and Instructional Procedures
Zeroing with the 0.0 McFarland Reference must be performed first. You do not have
to insert the other McFarland References (0.5, 2.0, and 3.0) in a particular order.
The instrument illuminates the tube and measures the McFarland Reference, during
the two second reading period. The corresponding McFarland value and status of the
McFarland Reference appears on the screen.The McFarland Status light on the Pod
also indicates the status of the McFarland Reference--red indicates a failing value and
green indicates a passing value. The LOT number appears on the screen, which
indicates it is a McFarland Reference and not a sample tube.
6. When the screen displays the McFarland value, confirm that the value displays with a
green colored meter gauge. If the meter gauge displays as the color red, the
McFarland Check has failed. Clean the McFarland Reference tube and try again. If the
problem persists, try another McFarland Reference set or contact a local bioMérieux
representative for assistance.
A McFarland value appears on the meter.
This value can be manually recorded for your record.
7. Remove the McFarland Reference.
The McFarland meter disappears when the tube is removed.
8. Repeat steps 5-7 for each McFarland Reference (0.5, 2.0, 3.0).
The McFarland Reference check is complete.
Related Links
Logging in to the VITEK FLEXPREP Software
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
Maintenance Schedule
Preventive Maintenance Operations
Zeroing Saline-Filled Test Tube
This procedure must be performed after a McFarland Reference check and as needed to
ensure that the results are accurate. Plastic tubes must be used with this device. If a glass
tube is used instead, the results can be inaccurate. Perform this zeroing procedure for each of
the following events:
•
•
•
•
After receiving a new shipment of test tubes.
After performing a McFarland Reference check.
As a part of routine monthly maintenance.
After relocating the instrument to a new lab environment.
CAUTION: Do not use an empty tube, a tube with an inoculated suspension,
or a glass tube to zero an instrument. The user must use a clean 12 mm x 75
mm polystyrene test tube, filled with saline to zero the instrument.
IMPORTANT:
048641-02
When moving the instrument from a stored location that is outside of the specified
operating temperature, you must allow the device temperature to stabilize before
performing the zeroing procedure and before measuring suspensions.
5-5
VITEK® DENSICHEK®
Prepare Suspensions
IMPORTANT:
Workflow and Instructional Procedures
To ensure your device is configured correctly, always zero the instrument before
measuring and recording McFarland values.
WARNING
Zeroing an instrument with an empty tube can cause incorrect values to
display when the inoculated suspension is inserted into the device.
1. Optional: If interfaced with the VITEK® FLEXPREP™ software, navigate to the Sample
Preparation screen within VITEK® FLEXPREP™ and go to the Quick McFarland Entry
or the new cassette screen.Place the Pod on the base unit, or if the Pod is charged,
hold the Pod while zeroing, if preferred.
2. Insert a saline-filled tube free of damage, scratches,or smudges into the front tube
location of the Pod and press it all the way down. Rotate the tube for the full 2 second
reading period, indicated by the dots on the screen. A numerical value is displayed.
3. If a value of 0.00 is not displayed, press and hold the button on the back of the Pod for
approximately three seconds. The Tube Light will flash and the two second reading
period begins. Rotate the tube for the full 2 second reading period, and 0.00 will
appear on the screen.
The test tube is zeroed, and you can begin preparing suspensions.
Related Links
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
Prepare Suspensions
When preparing a test tube to measure the McFarland value of a cultured isolate, you must
select the correct range type for microorganisms. The selected range must correspond to the
card type you are using.
Table 14: Display Screens and Corresponding Ranges
Display Screen
Displayed Reading Ranges
Performance Ranges
GN - GP
0.00 - 2.00
0.50 - 0.63
YST- BCL
0.00 - 4.00
1.80 - 2.20
CBC - NH - ANC
0.00 - 4.00
2.70 - 3.30
N/A
0.00 - 4.00
N/A
WARNING
The correct card type must be selected for a suspension in order for the
correct McFarland range to be used to evaluate the suspension. Failure to do
so can lead to incorrect evaluations of suspensions.
048641-02
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VITEK® DENSICHEK®
Prepare Suspensions
Workflow and Instructional Procedures
WARNING
Using a tube that is under-filled with saline can cause incorrect McFarland
value readings for inoculated suspensions. If you identify an under-filled
saline tube, do not use it.
CAUTION: The device is not intended for use with glass tubes. If you identify
a tube as glass, do not use it.
WARNING
Clumps in a suspension must be properly mixed before an accurate
McFarland value can be recorded. Clumps or contaminants in a suspension
can cause incorrect McFarland value readings. For accurate readings, ensure
the suspension is properly mixed.
WARNING
If saline or organism spills or drips on the Pod, clean the device with the
specified cleaning agent.
Failure to clean spills or drips on the Pod can cause incorrect McFarland
value readings for inoculated suspensions.
WARNING
After any cleaning, perform a McFarland Reference check prior to using the
VITEK® DENSICHEK® device again. Failure to do so can lead to inaccurate
readings.
WARNING
Spilling liquid in the device can cause malfunctioning. Do not dispense
saline into the test tube while it is in the Pod. In the event of an accidental
spill, immediately clean and dry the device, and then perform a McFarland
Reference check to confirm proper operation before continuing use.
Related Links
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
048641-02
5-7
VITEK® DENSICHEK®
Standalone Workflow (Display Base only)
Workflow and Instructional Procedures
Standalone Workflow (Display Base only)
Standalone workflows refer to using the VITEK® DENSICHEK® instrument with a Display
Base not connected to the VITEK® 2 software. A Display Base is required to use the VITEK®
DENSICHEK® with Standalone workflows.
Related Links
Graphical User Interface
Display Base Screen
VITEK FLEXPREP Software Interface Screen
Preparing Suspensions for ID and AST Cards (Standalone)
Ensure the Pod is paired with the base by verifying that the Pod and base both have the
same solid color pairing light. Zero the Pod at the beginning of each session by inserting a
saline tube free of damage, scratches,or smudges to the front tube location. Press the button
on the Pod for approximately three seconds. The Tube Light will flash and the two second
reading period will begin, indicated by the dots on the screen. Rotate the tube for the full 2
second reading period, and 0.00 will display.
WARNING
Failure to follow these instructions to prepare suspensions or to use test
tubes may cause incorrect results or the device to malfunction. It must be
assured that the zeroing was successful by confirming that the McFarland
gauge reads 0.00 following the saline tube zero.
WARNING
If a VITEK® DENSICHEK® device is not available, not charged, or not ready for
use, measure the turbidity of the inoculation with a comparable backup
VITEK® device. Failing to do so, may cause delayed results.
WARNING
Repeatedly inserting and removing a test tube during suspension creation
can cause scratches on the tube, which may lead to incorrect results.
WARNING
Only sample tubes specified in the user instructions should be used.
1. Press the Card Type button on the Display Base screen, until the desired card type
appears (ex. CBC - NH - ANC).
The card type options are as follows:
•
•
•
048641-02
GP - GN
BCL - YST
ANC - CBC - NH
5-8
VITEK® DENSICHEK®
Preparing Suspensions for ID and AST Cards (Standalone)
•
Workflow and Instructional Procedures
N/A (Miscellaneous)
Figure 43: Card Type Button on the Display Base (ANC - CBC - NH)
2. Ensure the test tubes are free of damage, scratches, and debris before use.
3. Do one of the following:
•
•
Select a tube and fill it with the appropriate volume of saline.
Select a pre-filled saline tube.
4. Add a microorganism to the saline-filled tube and manually mix the suspension in the
tube with a swab or loop until a homogenous solution is achieved.
5. Insert the prepared sample into the front tube location of the Pod and press it all the
way down. Once the instrument begins the two second reading period, designated by
the dots on the Display Base screen, rotate the tube for the full 2 seconds. The
McFarland value is measured, and displayed.
IMPORTANT: If the correct card type is not selected, then an acceptable McFarland range will
not appear on the meter. The correct card type must be selected in order for the
appropriate McFarland meter to appear.
IMPORTANT: If the #.## screen appears,either the swab is blocking the lens, a clump of
specimen is blocking the lens, or the suspension is too heavy. (See Appendix B
Troubleshooting for more information.)
WARNING
Ensure that the sample test tube is rotated at least one full rotation
and continuing to turn during the entire 2 second reading period.
Failure to do so can lead to incorrect McFarland results..
Note:
A green light on the Pod and meter indicates that the suspension is within the
selected card type performance range.A red light indicates that the suspension is
above the selected card type performance range. A yellow light indicates that the
suspension is below the selected card type performance range.
6. If the McFarland goes over range, perform one of the following solutions and then
remeasure the suspension following Step 5.
•
•
Discard the tube and repeat the previous steps to create a new suspension.
Dilute the over-inoculated sample with saline. - Remove the sample tube from the
Pod before adding saline to the suspension.
7. If the McFarland value measured is under range, add microorganism to the saline-filled
tube and manually mix the suspension in the tube with a swab or loop. Repeat Step 5
to measure sample.
8. Once an acceptable McFarland valueis measured, manually record the McFarland
value for your record (standalone mode).
9. Remove the suspension for ID and AST testing.
10. Perform this procedure with additional sample specimen tubes.
048641-02
5-9
VITEK® DENSICHEK®
Connectivity Workflow (Connectivity Base or Display Base)
Workflow and Instructional Procedures
Connectivity Workflow (Connectivity Base or Display Base)
The connectivity workflow refers to using the VITEK® DENSICHEK® instrument with the
compatible VITEK® 2 Systems software (ex. 9.01 or later).
IMPORTANT:
Do not connect more than one base unit to the same PC at the same time.
Related Links
Graphical User Interface
Display Base Screen
VITEK FLEXPREP Software Interface Screen
Logging in to the VITEK® FLEXPREP™ Software
If you are using the VITEK® 2 software compatible with VITEK® DENSICHEK®, follow this
procedure before performing the McFarland Reference checks.
1. Ensure the section Configure FLEXPREP with the Instrument has been performed.
2. For the VITEK® 2 PC, access VITEK® FLEXPREP™ on the desktop, and then doubleclick the FLEXPREP icon. For a remote PC, access VITEK® FLEXPREP™ by
launching the Firefox® browser. Refer to the VITEK® FLEXPREP™ Software User
Manual for configuration of VITEK® FLEXPREP™ from a remote PC.
The VITEK® FLEXPREP™ program launches in a Firefox browser window.
3. At the bioMérieux Single Sign-On screen, log in with the appropriate lab credentials.
Note:
See the bioMérieux User Management User Manual for information about accessing,
creating, and managing user accounts.
To reconfigure your VITEK® FLEXPREP™ settings or certificates, refer to the VITEK®
FLEXPREP™ User Manual.
The VITEK® FLEXPREP™ home screen appears with the Sample Preparation and
Configuration options.
Navigating the VITEK® FLEXPREP™ Software
Refer to the System Description and Basic Operations > System Basics > User Interface
section in Chapter 3 of this user manual for screen captures of the VITEK® FLEXPREP™
interface.
Note:
To manually type in the McFarland values during any workflow, navigate to the
Configuration screen, and set the Use VITEK DENSICHEK option to No and then Save the
setting. Follow the VITEK® FLEXPREP™ Software User Manual regarding the VITEK®
FLEXPREP™ Software.
1. Follow the Logging in to the VITEK® FLEXPREP™ Software procedure.
2. On the first Sample Preparation screen, enter data in the following fields:
•
•
•
048641-02
Lab ID
Isolate
Optional: Bench ID
5-10
VITEK® DENSICHEK®
Navigating the VITEK® FLEXPREP™ Software
In VITEK® FLEXPREP™, click Configuration, and then for the Display Bench
option, click Yes and then Save the setting. Refer to the VITEK® 2 Web Software
User Manual for more information about configuring your Bench settings.
Note:
•
•
Note:
Workflow and Instructional Procedures
[VITEK 2] PC
Cassette ID
If you are using a VITEK® 2 Compact instrument, enter a valid number (1-9) or
scan the barcode on the cassette in the Cassette ID field. If you are using a
VITEK® 2 instrument, the data for the Cassette ID field must be manually entered
each time.
3. Press Enter.
The second Sample Preparation screen appears with additional fields.
4. With your card, perform one of the following tasks depending on your preferred
method:
Option
Description
®
™
Using VITEK FLEXPREP ,
perform one of the following
tasks:
Click the Card Type field, and then scan the
barcode on the card. OR Manually enter the
barcode numbers in the Card Type field.
Using your VITEK®
DENSICHEK® Display Base,
perform the following task:
•
Press the Card Type button on the bottom of
the Display Base so that the appropriate card
type category appears.
IMPORTANT: When the instrument is connected to the VITEK® FLEXPREP™ PC, the user can
scan the card barcode and the instrument automatically adjusts to the correct
McFarland range for that particular card.
5. Follow the procedure for preparing suspensions for ID and AST cards.
6. Enter data in rest of the fields for the same isolate specimen.
Note:
There can be up to two AST cards per isolate, but only one ID card per isolate.
7. When an isolate is completed, click Validate (after a maximum of two AST cards and
one ID card).
8. Perform steps 4-7 for any remaining isolates.
Note:
If you entered card data in the first and second Sample Preparation screens, clicked
Validate, and then closed the browser to restart VITEK® FLEXPREP™, when VITEK®
FLEXPREP™ is opened again, it returns to the second Sample Preparation screen
with the validated card data present.
You can continue where you left off or click New Cassette to return to the first
Sample Preparation screen.
Note:
If you click New Cassette before clicking Send Cassette, the data entered for the
current cassette is erased and not saved. Clicking New Cassette also clears your
Bench settings. Always click Send Cassette in order to save the data entered for
each cassette.
9. Use the >/<When arrows to move to the previous or next card.
Note:
048641-02
To delete a card, navigate to the necessary card, and click Delete Card.
5-11
VITEK® DENSICHEK®
Preparing Suspensions for ID and AST Cards (Connectivity)
Workflow and Instructional Procedures
The highlighted card in the Abbreviated Summary view shifts to reflect your card
selection.
10. Click Summary on the right to view all the data for the cassette.
11. Click Back to return to the second Sample Preparation screen.
12. When the cassette is completed, click Send Cassette.
Note: If you click New Cassette before clicking Send Cassette, the data entered for the
current cassette is erased and not saved. Clicking New Cassette also clears your
Bench settings. Always click Send Cassette in order to save the data entered for
each cassette.
After clicking Send Cassette, the cassette is closed, and the data goes to the VITEK®
2 server. The cassette can be loaded in the corresponding VITEK® 2 instrument. The
first Sample Preparation screen appears and your Bench settings still appear.
13. Optional: Click New Cassette.
The screen refreshes and the first Sample Preparation screen appears. The previous
cassette data and the Bench settings are cleared. From here, you can enter a
Cassette ID, and begin the task from Step 1 again.
14. Click the PC: [VITEK] text to visit the Work List screen to view results, to view
isolates, or to define cards.
Refer to the VITEK® 2 Web Software User Manual for more information.
Note:
The [VITEK] text changes depending on what the user has named their PC.
A new tab opens with the Work List screen in the VITEK® 2 Systems Web application.
Related Links
Logging in to the VITEK FLEXPREP Software
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
Preparing Suspensions for ID and AST Cards (Connectivity)
Ensure the Pod is paired with the base by verifying that the Pod and base both have the
same solid color pairing light. Zero the Pod at the beginning of each session by inserting a
saline tube free of damage, scratches,or smudges to the front tube location. Press the button
on the back of the Pod for approximately three seconds. The Tube Light will flash, and the
two second reading period will begin. Rotate the tube for the full two seconds (or until the
McFarland value populates in the McFarland gauge in VITEK® FLEXPREP™). and 0.00 will
display.
WARNING
Failure to follow these instructions to prepare suspensions or to use test
tubes may cause incorrect results or the device to malfunction.
WARNING
Only sample tubes specified in the user instructions should be used.
048641-02
5-12
VITEK® DENSICHEK®
Preparing Suspensions for ID and AST Cards (Connectivity)
Workflow and Instructional Procedures
WARNING
If a VITEK® DENSICHEK® device is not available, not charged, or not ready for
use, measure the turbidity of the inoculation with a comparable backup
VITEK® device. Failing to do so, may cause delayed results.
WARNING
Repeatedly inserting and removing a test tube during suspension creation
can cause scratches on the tube, which may lead to incorrect results.
Note:
To manually type in the McFarland values during any workflow, navigate to the
Configuration screen, and set the Use VITEK DENSICHEK option to No and then Save the
setting. Follow the VITEK® FLEXPREP™ Software User Manual regarding the VITEK®
FLEXPREP™ Software.
1. Ensure the test tubes are free of damage, scratches, and debris before use.
2. Follow the Logging in to the VITEK® FLEXPREP™ Software procedure.
3. Follow the Navigating the FLEXPREP software procedure for defining the McFarland
range for the appropriate card type. The card type field populates with the card
information.When the correct card type and range appears (ex. GN/GP: 0.50 to 0.63),
continue to the next step.
4. Do one of the following:
•
•
Select a tube and fill it with the appropriate volume of saline.
Select a pre-filled saline tube.
5. Add a micro-organism to a saline-filled tube and manually mix the suspension with a
swab or loop until a homogeneous solution is achieved. Insert the prepared sample
into the front tube location of the Pod and press it all the way down.
IMPORTANT: If the #.## screen appears,either the swab is blocking the lens, a clump of
specimen is blocking the lens, or the suspension is too heavy. (See Appendix B
Troubleshooting for more information.)If a McFarland value is not displayed,
refer to Appendix B Troubleshooting.
6. Rotate for the full 2 second reading period or until a McFarland reading is displayed on
the gauge within VITEK® FLEXPREP™.
IMPORTANT:
If the correct card type is not selected, then an acceptable McFarland range will
not appear on the meter. The correct card type must be selected in order for the
appropriate McFarland meter to appear.
7. Add a microorganism to the saline-filled tube and manually mix the suspension in the
tube with a swab or loop until a homogenous solution is achieved.
8. If the McFarland goes over range, perform one of the following solutions:
•
•
Discard the tube and repeat the previous steps to create a new suspension.
Dilute the over-inoculated sample with saline. - Remove the sample tube from the
Pod before adding saline to the suspension.
9. Once an acceptable McFarland value appears on the screen, press the button on the
back of the Pod to transfer the McFarland value to VITEK® FLEXPREP™.
The saved McFarland value appears above the main number on the screen.
048641-02
5-13
VITEK® DENSICHEK®
Entering Multiple McFarland Values at Once
Workflow and Instructional Procedures
10. Ensure the value is sent to the interfaced PC and appears in the McFarland field on
the screen.
WARNING
Ensure that the sample test tube is rotated at least one full rotation
and continuing to turn during the entire 2 second reading period.
Failure to do so can lead to incorrect McFarland results..
11. Remove the suspension for ID and AST testing. The McFarland meter disappears
when the tube is removed.
12. Resume the procedure for Navigating the VITEK® FLEXPREP™ Software.
Related Links
Logging in to the VITEK FLEXPREP Software
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
Navigating the VITEK FLEXPREP Software
Entering Multiple McFarland Values at Once
Using the VITEK® 2 Logging in to the VITEK® FLEXPREP™ Software User Manual, access
Quick McFarland Entry feature.
Note:
To manually type in the McFarland values during any workflow, navigate to the
Configuration screen, and set the Use VITEK DENSICHEK option to No and then Save the
setting. Follow the VITEK® FLEXPREP™ Software User Manual regarding the VITEK®
FLEXPREP™ Software.
Enter Multiple McFarland values at once in Connectivity mode as follows:
1. Click the Lab ID field next to 1.
The cursor appears in the field.
2. Scan or type in the lab ID and isolate information for all samples.
3. Click the row for Isolate 1, and prepare the appropriate suspension for the card type
and insert the tube into the Pod and rotate the tube one full turn. Adjust the
suspension and remeasure as necessary. Refer to section for Preparing Suspensions
for ID and AST Cards (Connectivity).
Note:
In the DENSICHEK Gauge, you can minimize or expand the window as needed by
clicking the appropriate buttons. If the DENSICHEK Gauge is closed, it appears again
when a tube is inserted.
Note:
The DENSICHEK Gauge appears on the VITEK® FLEXPPREP™ screen when you
insert a tube into the Pod. Clicking the Card Type button on the DENSICHEK Gauge
changes the performance range for the McFarland meter.
4. Press the button on the Pod to capture the value.
The McFarland field populates with the McFarland value and the next row is
automatically highlighted for the next isolate. The cursor does not appear in the
McFarland field because it cannot be manually typed unless configured to do so.
5. Click the row for each of the isolates, and prepare suspension for each isolate and
press the button on the Pod to capture each McFarland value in the McFarland field.
048641-02
5-14
VITEK® DENSICHEK®
Preparing a QC Suspension in Quality Control Mode
Workflow and Instructional Procedures
6. To correct or edit a McFarland value, select the appropriate row, insert the suspension
tube into the Pod, rotate the tube for the full 2 second reading period, and press the
button on the Pod to save a new value.
7. When all the data is added to the Quick McFarland Entry window, remove the tube
from the Pod, and click OK to save.
8. Enter an appropriate ID in the Cassette ID field, and press Enter.
The second Sample Preparation screen appears. The McFarland Entries option is
active.
9. Click McFarland Entries on the right.
The McFarland Entries window appears with the data you entered previously, but it is
not editable.
10. Close the window and on the second Sample Preparation screen, enter an ID in the
Lab ID field.
Once the Lab ID is entered, the system pulls the appropriate McFarland values from
the Quick McFarland Entry window and populates the McFarland field.
11. Finish defining the cassette in VITEK® FLEXPREP™, and then click Send Cassette.
Note: Data entered in the Quick McFarland Entry window is specific to each PC. When
defining a cassette in VITEK® FLEXPREP™, the McFarland values auto populate in
the McFarland field when defining a cassette in VITEK® FLEXPREP™. The McFarland
values will only auto populate if the data was captured in Quick McFarland Entry on
the same PC. These values expire in one hour from time McFarland values are saved
in Quick McFarland Entry and will no longer auto populate into the McFarland field
when defining cassettes in VITEK® FLEXPREP™.
Note: Data from the Quick McFarland Entry window is not transferable when using the
Load and Go workflow in the VITEK® 2 Systems Web software (Cassette view).
Related Links
Logging in to the VITEK FLEXPREP Software
Preparing Suspensions for ID and AST Cards (Connectivity)
Preparing Suspensions for ID and AST Cards (Standalone)
Preparing a QC Suspension in Quality Control Mode
Preparing suspensions without Quality Control mode on is intended for patient samples. Turn
on Quality Control mode to perform a Quality Control workflow according to your lab
requirements.
1. Follow the Logging in to the VITEK® FLEXPREP™ Software procedure.
2. When the second Sample Preparation screen appears, click QC.
The QC (Quality Control) mode is turned on and the QC fields appear.
3. Enter the necessary QC data and refer to the VITEK® FLEXPREP™ Software User
Manual to use and understand the various available options in VITEK® FLEXPREP™.
Related Links
Logging in to the VITEK FLEXPREP Software
Updating Firmware
Users may be contacted by a bioMérieux representative with additional instructions and
information.
1. Place the Pod on the base unit.
048641-02
5-15
VITEK® DENSICHEK®
Updating Firmware
Workflow and Instructional Procedures
The Pod charges while placed on the base unit.
2. Ensure there is no tube in the Pod.
3. Using the provided USB cord, connect the instrument to the VITEK® 2 Systems PC.
The instrument communicates with the VITEK® 2 Systems PC and determines that a
firmware update is available.
4. Wait for the firmware update to complete.
The instrument receives the firmware update from the VITEK® 2 Systems PC and
performs the update. The Display Base screen visually indicate that the Pod's firmware
is updating. Once the update completes, the instrument resumes normal operation.
Related Links
Logging in to the VITEK FLEXPREP Software
048641-02
5-16
VITEK® DENSICHEK®
6
User Maintenance
For service information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
Required Tools
•
•
•
•
Paper towels
Soft, dry cloth
Neutral, non-abrasive detergent as defined in the Approved Cleaning Agents section.
Cloth or facial tissue
Calibration and Adjustments
The device is calibrated at the manufacturing site during assembly. The calibration is
confirmed with McFarland References, as described in Chapter 5, Performing McFarland
Reference Checks.
For information or for assistance, contact bioMérieux or your local distributor (contact
information available on www.biomerieux.com).
Preventive Maintenance Operations
Perform McFarland Reference checks regularly. If issues arise that are not documented in
this user manual, then contact your bioMérieux representative for assistance.
Perform McFarland Reference checks for the following events:
•
•
•
•
After receiving a new shipment.
As a part of routine monthly maintenance.
After cleaning the device.
After relocating the instrument to a new lab environment.
Related Links
Maintenance Schedule
Preventive Maintenance Operations
Cleaning Procedures
Approved Cleaning Agents
•
•
•
•
048641-02
10% sodium hypochlorite (bleach)
3% – 25% hydrogen peroxide
Vesphene IIse
LpH se
6-1
VITEK® DENSICHEK®
Cleaning Procedures
User Maintenance
Cleaning the Pod Windows
1.
2.
3.
4.
5.
6.
7.
Remove Pod from base.
Dampen a cotton swab with an Approved Cleaning Agents as listed above, and then
squeeze out any excess liquid.
Carefully wipe each window of the front tube location, shown in the image below. Be
cautious not to bend any of the parts inside.
Visually inspect the tube locations to ensure no debris remains.
Allow Pod to completely air dry.
Perform McFarland Reference Check as described in Chapter 5, Performing McFarland
Reference Checks.
Perform the Zeroing Saline Filled Test Tubes, described in Chapter 5.
Use the image below to locate the windows for the optical lenses, tube light and RFID.
Figure 44: Windows in the Pod
1.
Optical Windows
WARNING
Only use the approved cleaning materials, agents, and tools. Using nonapproved cleaning materials can damage the reading lenses. Do not use
strong solvents, including alcohol.
Cleaning the Touch Screen
Wipe the Display Base Touch Screen using paper towels or wipes that are dampened with
with an Approved Cleaning Agent. Then dry with a soft clean cloth.. Always dampen the towel
first and then clean the screen. See the list of approved cleaning agents above.
048641-02
6-2
VITEK® DENSICHEK®
Decontamination Procedures
User Maintenance
CAUTION: Do not spray cleaner directly on the screen. Spraying the screen
directly can damage the device.
Cleaning the Base and Pod
Wipe the base and the Pod using paper towels or wipes that are dampened with with an
Approved Cleaning Agent. See the list of approved cleaning agents above.
Once you have cleaned the base and/or the pod, allow the device to dry, and then perform a
McFarland Reference check to ensure that the instrument continues to take accurate
readings.
WARNING
Only use the approved cleaning agents. Using non-approved cleaning agents
can damage the instrument. Do not use strong solvents, including alcohol.
WARNING
Spilling liquid in the device can cause malfunctioning. Do not dispense
saline into the test tube while it is in the Pod. In the event of an accidental
spill, immediately clean and dry the device, and then perform a McFarland
Reference check to confirm proper operation before continuing use.
Related Links
Maintenance Schedule
Preventive Maintenance Operations
Decontamination Procedures
If decontamination is necessary due to a biological hazard, refer to Cleaning Procedures
using a 10% bleach solution and allow it to remain in contact with the contaminated surface
for five minutes.
For information or for assistance, contact bioMérieux or your local distributor (contact
information available on www.biomerieux.com).
Related Links
Cleaning Procedures
048641-02
6-3
VITEK® DENSICHEK®
A
Appendix - Maintenance Records
Maintenance Schedule
Table 15: Maintenance Schedule
Part
Frequency
Procedure
According to your local
regulatory guidelines, or at
least on a monthly basis.
Chapter 5, Performing
McFarland Reference
Checks.
VITEK® DENSICHEK®
McFarland Reference Kit
According to your local
regulatory guidelines, or at
least on a monthly basis.
Chapter 5, Performing
McFarland Reference
Checks.
VITEK® DENSICHEK®
Instrument
As Required
Chapter 6, Cleaning
Procedures.
®
VITEK DENSICHEK
Instrument
®
WARNING
The VITEK® DENSICHEK® McFarland Reference Kit must be replaced if the
individual vials are damaged or scratched in such a way that they cause
erroneous results.
Related Links
Cleaning Procedures
Maintenance Checklist
Checklist 1
Year:
Month:
Month
Part name
1
2
3
4
5
6
7
8
9
10
11
12
Frequency
®
®
VITEK DENSICHEK Device/
M
Instrument; McFarland Reference
Check
Frequency: M = Monthly, 6M = Every 6 months, N = if needed
Complete with your initials. Keep a copy of the preventive maintenance charts.
Checklist 2: Daily, Part 1
Year:
Month:
048641-02
A-1
VITEK® DENSICHEK®
Maintenance Checklist
Appendix - Maintenance Records
Day
Part name
1
2
3
4
5
6
7
8
9
1 11 1 1
0
2 3
1
4
1
5
1
6
Frequency
®
®
VITEK DENSICHEK Device/
Instrument; McFarland
Reference Check
N
VITEK® DENSICHEK® Device/
Instrument; Cleaning
N
Frequency: M = Monthly, 6M = Every 6 months, N = if needed
Complete with your initials. Keep a copy of the preventive maintenance charts.
Checklist 3: Daily, Part 2
Year:
Month:
Day
Part name
®
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Frequency
®
VITEK DENSICHEK Device/
Instrument; McFarland
Reference Check
N
VITEK® DENSICHEK® Device/
Instrument; Cleaning
N
Frequency: M = Monthly, 6M = Every 6 months, N = if needed
Complete with your initials. Keep a copy of the preventive maintenance charts.
048641-02
A-2
VITEK® DENSICHEK®
B
Appendix - Troubleshooting
Related Links
Cleaning Procedures
Error Messages and Recovery Procedures
This section lists the possible error messages and general problems that could occur when
using the device.
WARNING
Failure to address error messages in a proper and/or timely manner may
cause the device to malfunction.
WARNING
You must operate the device within the specified environmental conditions,
including the specific ambient laboratory humidity conditions and the
specified ambient laboratory lighting conditions. Failing to do so, may cause
the device to malfunction.
Problem Resolution
Error Message / Problem
Cause
Resolution
McFarland value is inconsistent.
Test tubes may be
dirty or scratched
(inside or outside).
Replace the test
tubes as required.
Test tubes may not
be filled to sufficient
level.
Adjust saline level.
Instrument is not
Zero on tube type in
zeroed on type of test use.
tube in use.
Test tube does not
Confirm test tube is a
meet required criteria. clean 12 mm x 75
mm polystyrene test
tube that is clear,
colorless, and free of
scratches.
Test tube not properly Insert the test tube so
inserted in the Pod.
it is fully seated and
upright in the Pod
Ambient light is too
bright to make an
accurate
measurement.
048641-02
B-1
Relocate instrument
away from bright light
sources.
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
Resolution
The instrument is unable to save data.
Various causes.
Contact bioMérieux
Technical Support.
The VITEK® FLEXPREP™ software is not
The device is
reflecting what is shown on the Display Base. disconnected from
the PC.
Re-seat test tube in
Pod and re-measure.
If problem is not
resolved, reconnect
the Base to the PC,
and then restart the
VITEK® FLEXPREP™
software or, restart
the PC and then open
the VITEK®
FLEXPREP™
software.
The VITEK® FLEXPREP™ software is not
registering that a base is connected.
The device is
disconnected from
the PC.
Reconnect the Base
to the PC, and then
restart the VITEK®
FLEXPREP™
software. If problem
is not resolved,
restart the PC and
then open the
VITEK® FLEXPREP™
software.
The Communication
Bridge or the related
certificates are not
installed and
configured on the PC.
Connect the base to
the PC, and then
restart the PC. Then
complete all of the
procedures included
in the Configure
VITEK® FLEXPREP™
with the Instrument
section.
The USB power cord
gets disconnected
from the base.
Reconnect the USB
power cord to the
base.
The Pod does not
hold its charge
because of normal
wear and tear.
Contact bioMérieux
Technical Support.
The card is not
defined in your
VITEK® 2 System.
Refer to the VITEK® 2
Software User
Manual or VITEK® 2
Web Software User
Manual for
instructions on
Maintain AST Card
Definitions.
Momentary loss of power.
The following error message appears:
Figure 45: Error Message
048641-02
B-2
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
A suspension with an organism is inserted
The device needs to
into the Pod but X.XX appears on the screen. be cleaned.
Figure 46: X.XX Results
A suspension with an organism is inserted
into the Pod but #.## appears on the screen.
Figure 47: #.## Results
A tube is inserted into the Pod but 0.00 is
flashing on the screen.
Figure 48: 0.00 Results
048641-02
B-3
Resolution
Follow the cleaning
procedure and
requirements listed in
this user manual.
Device needs to be
re-zeroed.
Follow steps in
Performing
McFarland Reference
Checks and Zeroing
Saline-Filled Test
Tube.
One or more lenses
are dirty.
Clean the test tube
chamber.
The tube is
scratched.
Use a different tube.
Alcohol was used to
clean the device and
one or more lenses
are damaged.
Contact bioMérieux
Technical Support.
The McFarland range Create a new
is over 4.0.
suspension following
the instructions in this
user manual.
A clump of specimen
is blocking the lens.
Continue to mix the
specimen until all
clumps are gone and
the lens is unblocked.
A loop or swab is
blocking the lens.
Remove the loop or
swab from the
suspension.
The Pod was zeroed Zero the device using
previously with a tube a tube filled with clear
that was not as clear, saline.
and the next tube
inserted is clear. The
system cannot
reliably calculate a
McFarland value and
needs to be zeroed
with a clear salinefilled tube inserted.
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
®
When installing the DENSICHEK Bridge
Communication service, the Not Enough
Disk Space warning appears, similar to the
image below:
Figure 49: Not Enough Disk Space
Warning
Resolution
The correct drive is
Remove all USB
not available to install memory devices,
the service.
CDs, and DVDs
before running the
DENSICHEK® Bridge
Installer.
The colored light on the Pod does not match The Bluetooth
the base. Therefore, the Pod fails to pair with connection between
the base.
the Pod and the base
needs to be
reestablished.
Remove and re-place
the Pod on the base
to pair. Wait for the
LED lights on the Pod
and the base to
match.
Unplug and re-plug in
the base. Wait for the
LED lights on the Pod
and the base to
match.
048641-02
The Pod turns off.
The Pod battery
Charge the Pod by
needs to be charged. placing it on a base
unit.
Base physically connected to PC and the
colored light on the Pod flashes red.
The Bluetooth
connection between
the Pod and base
needs to be
established.
Place the Pod on the
base to pair. Wait for
LED lights on the Pod
and the base to
match. If issue is not
resolved, restart the
PC.
The base turns off.
The base has been
unplugged.
Ensure the correct
cord is plugged into
the base and a power
source.
The firmware update does not complete.
The base has been
unplugged from the
PC.
Ensure the correct
cord is plugged into
the base and the
VITEK® 2 Systems
PC.
B-4
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
®
Cause
Resolution
™
In VITEK FLEXPREP , after clicking OK to The same Lab ID was Click OK, replace the
save your card data in the Quick McFarland entered twice.
duplicated data by
Entry window, the following error message
clicking the Lab ID
appears: The Accession Numbers for rows
field, entering a new
[#] and [#] are the same. Please resolve
Lab ID, and clicking
the duplication.
OK when all the fields
are entered and
unique.
In VITEK® FLEXPREP™, after clicking OK to Not all the values are • Enter the missing
save your card data in the Quick McFarland completed for a row.
values and click
Entry window, the following error message
OK.
appears: Row [X] is incomplete; either
OR
clear it all or fill in all values to proceed.
•
048641-02
B-5
Click Cancel to
close the window
and to clear the
values, and then
reopen the Quick
McFarland Entry
window to enter
the values again.
If the issues
persists, restart
the FLEXPREP™
program.
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
Resolution
The McFarland range of the card type
selected on the Display Base does not match
the McFarland range of the card type
scanned in VITEK® FLEXPREP™.
The incorrect card
type was selected on
the Display Base.
(Ex. The user wants
to scan a BCL card,
but a GN - GP range
was selected on the
Display Base).
1.
2.
3.
A tube is inserted into the Pod, but the Pod
fails to illuminate the tube.
FLEXPREP™
alerts the user
that the
McFarland
range sent by
the instrument is
different from
the McFarland
range of the
scanned card.
The user scans
the correct card.
The results
populate
correctly and the
Display Base
matches the
scanned card
(ex. a BCL card
is scanned, and
the GN - GP
range changes
to the YST BCL range).
The user
creates a new
suspension
using a correct
McFarland
range.
The device sensor is
malfunctioning.
Contact bioMérieux
Technical Support.
The tube is not
inserted correctly.
Review the Preparing
Suspensions for ID
and AST Cards
procedure.
The tube is not
pressed into the Pod
completely.
Press the tube down
in the Pod.
The tube is inserted
Insert the tube in the
in the wrong location. front tube location on
the Pod.
A McFarland reference is in the pod but the
McFarland meter does not appear in VITEK®
FLEXPREP™.
048641-02
B-6
Configuration screen
is not selected in
VITEK®
FLEXPREP™.
Navigate to
Configuration screen
in VITEK®
FLEXPREP™ and reinsert McFarland
reference into the
pod.
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
Resolution
Tube is not illuminated.
Pod is configured to
Access the
the lowest Tube Light configuration page for
setting.
the base, and
increase the value for
Tube Light.
The base does not turn on even though it is
plugged in.
Various causes.
Contact bioMérieux
Technical Support.
A suspension is in the Pod, but -.-- appears
Pod is failing to sense Remove suspension
on the screen for the McFarland value similar the presence of the
and attempt to reto the image below.
suspension.
measure. If the issue
still does not
resolve,contact
bioMérieux Technical
Support.
User touches the screen and nothing
happens, the screen goes blank, or the
screen freezes.
Various causes.
1.
2.
3.
Unplug and replug in the base.
Remove the Pod
from the base,
and the place it
back on the
base.
If the issue
persists, contact
bioMérieux
Technical
Support.
A McFarland Reference is in the Pod and the RFID tag fails, sensor Contact bioMérieux
McFarland value appears on the screen, but fails, or reading of
Technical Support.
the LOT number does not appear.
McFarland value fails.
Device does not function as expected.
Pod or base is
dropped or falls from
the work bench.
1.
2.
3.
048641-02
B-7
Inspect for
damage.
Perform a
McFarland
Reference
check.
If the issue
persists, contact
bioMérieux
Technical
Support.
VITEK® DENSICHEK®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Problem Resolution
Error Message / Problem
Cause
Resolution
The McFarland value does not appear on the The Bluetooth
Unplug the base, and
screen, because the Pod fails to pair with the connection between then plug in the base
base.
the Pod and the base again to restart it.
needs to be
reestablished. The
Pod is still reading
the suspension, but
it's not sending the
data from the Pod to
the base.
In Connectivity Workflow: McFarland Gauge
fails to show in VITEK® FLEXPREP™.
VITEK® FLEXPREP™
is not in Quick
McFarland Entry
screen or Cassette
Prep screen.
Navigate to the
McFarland Quick
Entry or Cassette
Preparation screen.
Pod did not trigger
the transmission of a
McFarland message
to VITEK®
FLEXPREP™.
Remove and re-insert
the tube.
Related Links
Cleaning Procedures
Connecting the Device
Configure VITEK FLEXPREP with the Instrument
Configuring the DENSICHEK Certificates in VITEK FLEXPREP
Downloading and Installing the DENSICHEK Communication Bridge
Configuring the Display Base Settings
Configuring the Connectivity Base Settings
048641-02
B-8
VITEK® DENSICHEK®
C
Appendix - Third-Party Software
Third party software and any parts thereof identified in the left-hand column are subject to the
terms and conditions under which the specific licenses identified in the right-hand column are
granted.
048641-02
Third-party software and parts
License
Apache server
GPL compatible (Apache version 2): http://
www.apache.org/licenses/
Jboss application server
GNU LGPL: http://www.jboss.org/infinispan/
license.html
Module BIRT
Eclipse public license (EPL): http://en.wikipedia.org/
wiki/Eclipse_Public_License
OpenDS
Common Development and Distribution License
(CDDL): https://opends.dev.java.net/
OpenDS.LICENSE
PostgreSQL
BSD license: http://www.postgresql.org/about/
licence
C-1
VITEK® DENSICHEK®
Appendix - Third-Party Software
Third-party software and parts
License
Modules
ActiveMQ: http://www.apache.org/licenses/
LICENSE-2.0.html
Drools: http://www.apache.org/licenses/
LICENSE-2.0.html
Joda: http://joda-time.sourceforge.net/license.html
hibernate: http://www.hibernate.org/license.html
Apache common: http://www.apache.org/licenses/
LICENSE-2.0.html
Dozer: http://www.apache.org/licenses/
LICENSE-2.0
Sun JRE 1.6.0: Sun Microsystems, Inc. Binary Code
License Agreement Copyright © 2006 Sun
Microsystems, Inc., 4150 Network Circle, Santa
Clara, California 95054, U.S.A. All rights
reserved.U.S.: http://java.sun.com/javase/6/
webnotes/runtime.html
RichFaces: GNU LGPL http://www.gnu.org/licenses/
lgpl.html
http://www.jboss.org/richfaces/download/stable.html
Seam: GNU LGPL http://www.gnu.org/licenses/
lgpl.html
http://seamframework.org/Download
Tomhawak: http://www.apache.org/licenses/
LICENSE-2.0.html
PrimeFaces: http://www.apache.org/licenses/
LICENSE-2.0.html
Facelet: http://www.apache.org/licenses/
LICENSE-2.0.html
slf4j: http://www.slf4j.org/license.html
JfreeChart : http://www.gnu.org/licenses/lgpl.html
Jackrabbit : http://www.apache.org/licenses/
LICENSE-2.0
VITEK® MS module
SLF4J 1.5.6 : http://www.slf4j.org/license.html
Sping 3.0.3.RELEASE : http://www.apache.org/
licenses/LICENSE-2.0.html
Jmzml 1.2.1 : http://www.apache.org/licenses/
LICENSE-2.0.html
JRE 1.6.0.20 : http://java.sun.com/javase/6/jdk-6u2license.txt
Matlab 7.14 : See the file "MATLAB-license.txt" in
the "D:\biomerieux\programs\licenses" directory
048641-02
C-2
VITEK® DENSICHEK®
Appendix - Third-Party Software
Third-party software and parts
License
BCI link module
Spring: http://www.apache.org/licenses/
LICENSE-2.0.html
Jcalendar: http://www.toedter.com/en/jcalendar/
license.html
Jdom: http://www.jdom.org/docs/faq.html#a0030
Jta: https://source.db4o.com/db4o/trunk/drs/lib/
jta.license.html
slf4j: http://www.slf4j.org/license.html
rxtx: http://users.frii.com/jarvi/rxtx/license.html
048641-02
C-3
VITEK® DENSICHEK®
D
Appendix - Glossary
Connectivity Base
A base unit without a display that syncs with and charges the Pod. This base unit sends data
to the VITEK® 2 software compatible with the DENSICHEK® software.
Connectivity Workflow
This workflow refers to using the VITEK® DENSICHEK® device with the VITEK® 2 software
that is compatible with the device.
Display Base
The Display Base syncs to and charges the Pod. This base has a display screen where the
McFarland reading appears when a tube is inserted into the Pod. This base can also transmit
information to the VITEK® 2 software that is compatible with the VITEK® DENSICHEK®, if the
user has access to the software.
McFarland References
These references are dual-vials with 0.0, 0.5, 2.0, and 3.0 McFarland values that verify the
calibration of the optics contained within the Pod.
McFarland Reference Check
A procedure performed by user to confirm that the calibration is accurate. This preventive
maintenance activity is required to confirm the device measurements
Pod
The Pod optically reads the turbidity of a microorganism suspension and sends the
information to the base unit.
Standalone Workflow
This workflow refers to using the VITEK® DENSICHEK® instrument with a Display Base
without the VITEK® 2 software compatible with the DENSICHEK®.
048641-02
D-1
VITEK® DENSICHEK®
Revision History
This section contains a summary of changes made to each released revision of this document
starting with part number:
048641-01.
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
Date
Part Number
Change Type
Change Summary
2022-02
048641-02
Technical change
Updated Radio Specifications
2018-10
048641-01
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