®

VITEK DensiCHEK

User Manual
048641-01 - en - 2018-08

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
.......................................................................................................................... 2-4
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
.......................................................................................................................... 3-7
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
.......................................................................................................................... 4-4
Charging the Pod.............................................................................................. 4-4
Pairing a Pod with a Base................................................................................. 4-5
Configuring the Display Base Settings..............................................................4-5
Configure FLEXprep™ with the Instrument..................................................................4-7
.......................................................................................................................... 4-7
Downloading and Installing the DensiCHEK® Communication Bridge............. 4-7
Configuring the DensiCHEK® Certificates in FLEXprep™................................ 4-9
Configuring the Connectivity Base Settings.................................................... 4-10
User Management...........................................................................................4-12

Workflow and Instructional Procedures............................................................... 5-1

Starting the System......................................................................................................5-1
Shutting Down the System...........................................................................................5-1
Understand McFarland Reference Ranges................................................................. 5-1

048641-01 i VITEK® DensiCHEK

Table of Contents

Performing McFarland Reference Checks........................................................ 5-3

Zeroing Saline-Filled Test Tube................................................................................... 5-5
Prepare Suspensions...................................................................................................5-6
Standalone Workflow (Display Base only)................................................................... 5-7
Preparing Suspensions for ID and AST Cards (Standalone)............................ 5-7
Connectivity Workflow (Connectivity Base or Display Base)....................................... 5-9
Logging in to the VITEK® 2 FLEXprep™ Software..........................................5-10
Navigating the 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

Revision History

048641-01 ii 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

BIOMERIEUX, the BIOMERIEUX logo and VITEK 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.
© 2017 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. This device may not cause harmful interference, and
2. 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. This device may not cause interference, and
2. 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. l'appareil ne doit pas produire de brouillage, et
2. 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
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:
• 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.

048641-01 1-1 VITEK® DensiCHEK

Warning and Safety Messages 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.

Note: 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. No seams, scratches, or imperfections are allowed in this optical path area

2. 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.

048641-01 1-2 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: An Important statement relates to content presented in the user documentation. It is

used to reinforce the user’s understanding of selected information.

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

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.

048641-01 1-3 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.

048641-01 1-4 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: 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.

048641-01 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

Compliance with US and Canadian

CE-Marking of Conformity
Safety Standards certified by CSA

Compliance with China RoHS

UL Listed to US and Canadian Safety
Regulation (Chinese Standard SJ/
Standards
T11364)

In Vitro Diagnostic Medical Device Batch code

Authorized Representative in the

Catalogue number
European Community

Serial number Consult Instructions for Use

Use by date Manufacturer

Date of manufacture This way up

Caution, consult accompanying

Do not stack
documents

Contains sufficient for <n> tests Do not reuse

048641-01 1-6 VITEK® DensiCHEK

Standard Symbols 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

048641-01 1-7 VITEK® DensiCHEK

Standard Symbols Introduction to the System

Corrosives Sodium azide

Irritant Recyclable

Environmentally friendly use period.

Separate collection for waste electrical Actual number of years may vary by
and electronic equipment product. This symbol is typically
orange in color.

Fuse Direct current

Alternating current Both direct and alternating current

Three-phase alternating current Earth (ground) terminal

Protective conductor terminal Frame or chassis terminal

Equipotentiality ON (supply)

ON (only for a component of the

OFF (supply)
system equipment)

Equipment protected throughout by

OFF (only for a component of the double insulation or reinforced
system equipment) insulation (Equivalent to Class II of IEC
536)
FCC-Approved Equipment Labels for
Ethernet port
Part 15 devices
Regulatory Compliance Mark (RCM)
For US Only - Caution: US Federal
for Electrical Quipment Safety System
Law restricts this device to sale by or
(EESS) from the Electrical Regulatory
on the order of a licensed practitioner
Authorities Counsil (ERAC) in Australia

048641-01 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 product.

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).

048641-01 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

048641-01 2-2 VITEK® DensiCHEK

Instrument Labels Safety Information

Figure 5: Labels for McFarland Reference Test Tubes - LOT Number View

Figure 6: Instrument Label Example- Charging Base

Figure 7: Instrument Label Example- Pod

Figure 8: Instrument Label Example - Display Base

048641-01 2-3 VITEK® DensiCHEK

 Safety Information

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.

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.

048641-01 2-4 VITEK® DensiCHEK

Safety Precautions Safety Information

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.

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

malfunctioning. If liquid is spilled on the system, wipe it up immediately
using decontamination wipes.

CAUTION: The computer and its operating system have been carefully
configured for optimal system performance. Altering the configuration may
severely hamper the usability of the instrument.

Note: Before performing electrical safety or other compliance testing on the instrument, contact
bioMérieux or your local distributor.

WARNING
The user must only perform the maintenance operations described in this
document and rigorously follow each of the steps.
The use of tools not specified by bioMérieux is forbidden.
Powder-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.

048641-01 2-5 VITEK® DensiCHEK

Safety Precautions Safety Information

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.

048641-01 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:
• Clinical Specimen
• Industry Specimen - Water, air, food samples.

048641-01 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).
• VITEK® DensiCHEK® Display Base
• VITEK® DensiCHEK® Connectivity Base (for the VITEK® 2 software compatible with the
DensiCHEK® users)

048641-01 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

Parameter Characteristics
Length 120.0 mm
Width 102.0 mm
Height 35.2 mm

048641-01 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 instrument may 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:

Specification Value
Voltage 100-240 VAC
Frequency 50-60 Hz
Current 1A
Power 30 Watts

048641-01 3-4 VITEK® DensiCHEK

Radio Specifications System Description and Basic Operations

Note: 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 2.4-2.8 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

Specification Value
Relative humidity 20% to 80% non-condensing
Humidity during storage and transport 20% to 85% non-condensing

048641-01 3-5 VITEK® DensiCHEK

Altitude System Description and Basic Operations

Altitude
Specification Value
Maximum altitude 2000 m

Sound Level
Specification Value
In Operating Mode Sound level is lower than 70 dB

Operating Lighting Conditions

Specification Value
Maximum Ambient Light in In Operating 750 Lux
Mode

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® 2 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

048641-01 3-6 VITEK® DensiCHEK