Qiagen QIAcube Connect MDx User manual

Sample to Insight__
December 2020
QIAcube® Connect
MDx User Manual
The QIAcube Connect MDx is intended for in vitro diagnostic use.
9003070
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
R1
11
21932

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Contents
1Introduction .............................................................................................................6
1.1 About this user manual ...............................................................................6
1.1.1 Technical assistance ................................................................................6
1.1.2 Policy statement .....................................................................................7
1.2 Intended use of the QIAcube Connect MDx ....................................................7
1.3 Requirements for QIAcube Connect MDx users ...............................................7
1.4 Glossary....................................................................................................8
1.5 Accessories ................................................................................................8
2Safety Information....................................................................................................9
2.1 Proper use .................................................................................................9
2.2 Electrical safety ........................................................................................11
2.3 Environment.............................................................................................12
2.4 Biological safety .......................................................................................13
2.5 Chemicals ................................................................................................14
2.6 Waste disposal.........................................................................................15
2.7 Mechanical hazards..................................................................................15
2.7.1 Centrifuge............................................................................................16
2.8 Heat hazard ............................................................................................17
2.9 Maintenance safety...................................................................................17
2.10 Radiation safety .......................................................................................19
2.11 Symbols on the QIAcube Connect MDx........................................................20
3General Description................................................................................................21
3.1 QIAcube Connect MDx principle .................................................................22
3.2 External features of the QIAcube Connect MDx.............................................24
3.3 Internal features of the QIAcube Connect MDx .............................................29
3.4 Disposables .............................................................................................36
4Installation Procedures ............................................................................................38
4.1 Installation environment ............................................................................38
4.1.1Site requirements..................................................................................38

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4.1.2 Power requirements ..............................................................................39
4.1.3 Grounding requirements........................................................................40
4.2 Unpacking the QIAcube Connect MDx .........................................................40
4.3 Installing the QIAcube Connect MDx ...........................................................41
4.3.1 Removal of the QIAcube Connect MDx accessories and shipping material....41
4.3.2 Installation of AC power cord.................................................................42
4.3.3 Installation of external barcode scanner ..................................................43
4.3.4 Installing the centrifuge rotor and buckets................................................43
4.3.5 Installing the shaker adapter..................................................................44
4.4 Configuration of the QIAcube Connect MDx .................................................45
4.4.1 System configurations ...........................................................................46
4.4.2 Settings configuration............................................................................48
4.4.3 Network configuration ..........................................................................49
4.5 Packaging and transporting of the QIAcube Connect MDx .............................53
5Operating Procedures .............................................................................................55
5.1 QIAcube Connect MDx software .................................................................58
5.2 Switching the QIAcube Connect MDx on and off...........................................61
5.3 Logging in and Logging out .......................................................................62
5.4 Setting up a protocol run ...........................................................................63
5.4.1 Material selection .................................................................................67
5.4.2 Protocol selection..................................................................................68
5.4.3 Parameter definition .............................................................................69
5.4.4 Sample number definition......................................................................70
5.4.5 Loading buffer bottles ...........................................................................70
5.4.6 Loading tips and enzymes .....................................................................73
5.4.7 Loading the centrifuge...........................................................................75
5.4.8 Loading the shaker ...............................................................................82
5.5 Starting a protocol run ..............................................................................85
5.6 Stopping a protocol run.............................................................................87
5.7 Saving run reports to the USB flash drive.....................................................88
5.8 Low space on flash memory.......................................................................90

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5.9 Independent heater/shaker operation .........................................................90
5.10 Independent centrifuge operation ...............................................................92
5.11 Managing protocols..................................................................................95
5.11.1 Installing new protocols.........................................................................95
5.11.2 Deleting all protocols.............................................................................96
5.11.3 Saving protocols...................................................................................97
5.12 Updating software....................................................................................98
5.13 User Management ..................................................................................100
5.13.1 Setting up a new user .........................................................................101
5.13.2 Changing data for an existing user .......................................................103
5.13.3 Deleting or temporarily deactivating a user............................................104
5.13.4 Changing password............................................................................105
6Cleaning and Maintenance....................................................................................107
6.1 Cleaning agents .....................................................................................108
6.2 Disinfection ............................................................................................108
6.3 Regular maintenance ..............................................................................111
6.4 Daily maintenance..................................................................................111
6.5 Monthly maintenance..............................................................................113
6.6 Periodic maintenance ..............................................................................114
6.6.1 Cleaning the robotic arm modules.........................................................114
6.6.2 Cleaning the centrifuge........................................................................115
6.6.3 Operating the centrifuge after cleaning .................................................120
6.7 Optional Maintenance.............................................................................121
6.7.1 UV run ..............................................................................................121
6.7.2 Tightness test......................................................................................123
6.8 Decontaminating the QIAcube Connect MDx ..............................................124
6.9 Servicing ...............................................................................................124
7Troubleshooting ...................................................................................................125
7.1 Contacting QIAGEN Technical Services ......................................................125
7.2 Creating a support package.....................................................................125
7.3 Operation..............................................................................................126

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7.3.1 Protocol interruption ...........................................................................129
7.3.2Centrifuge..........................................................................................129
7.3.3 Reagent volume detection and ultrasonic pipe ........................................131
7.3.4 Touchscreen .......................................................................................132
7.3.5 O-Ring exchange................................................................................134
8Glossary .............................................................................................................140
9Appendix A – Technical data .................................................................................142
9.1 Operating conditions...............................................................................142
9.2 Transport conditions................................................................................142
9.3 Storage conditions ..................................................................................142
9.4 Mechanical data and hardware features ...................................................143
9.5 Declaration of Conformity........................................................................144
9.6 Waste Electrical and Electronic Equipment (WEEE) .......................................144
9.7 EMC Declaration.....................................................................................145
9.8 Liability Clause .......................................................................................146
10 Appendix B – QIAcube Connect MDx Accessories.....................................................148
11 Version history.....................................................................................................151
Index 152

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1Introduction
Thank you for choosing the QIAcube Connect MDx. We are confident it will become an integral
part of your laboratory. Before using the QIAcube Connect MDx, it is essential that you read this
user manual carefully and pay attention to the safety information. The instructions and safety
information in the user manual must be followed to ensure safe operation of the instrument and to
maintain the instrument in a safe condition.
1.1 About this user manual
This user manual provides information about the QIAcube Connect MDx in the following sections:
1. Introduction
2. Safety Information
3. General Description
4. Installation Procedures
5. Operating Procedures
6. Cleaning and Maintenance
7. Troubleshooting
8. Glossary
9. Appendix A – Technical data
10.Appendix B – QIAcube Connect MDx Accessories
11.Version history
1.1.1 Technical assistance
At QIAGEN®, we pride ourselves on the quality and availability of our technical support. Our
Technical Services Departments are staffed by experienced scientists with extensive practical and
theoretical expertise in molecular biology and the use of QIAGEN products. If you have any
questions or experience any difficulties regarding the QIAcube Connect MDx or QIAGEN products
in general, do not hesitate to contact us.
QIAGEN customers are a major source of information regarding advanced or specialized uses of
our products. This information is helpful to other scientists as well as to the researchers at QIAGEN.
We therefore encourage you to contact us if you have any suggestions about product performance
or new applications and techniques.

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For technical assistance and more information, please see our Technical Support Center at
www.qiagen.com/support/technical-support or call one of the QIAGEN Technical Service
Departments or local distributors (see back cover or visit www.qiagen.com).
For up-to-date information about QIAcube Connect MDx instrument, visit
https://www.qiagen.com/products/qiacube-connect-mdx.
1.1.2 Policy statement
It is the policy of QIAGEN to improve products as new techniques and components become
available. QIAGEN reserves the right to change specifications at any time.
To produce useful and appropriate documentation, we appreciate your comments on this user
manual. Please contact QIAGEN Technical Services.
1.2 Intended use of the QIAcube Connect MDx
QIAcube Connect MDx is designed to perform automated isolation and purification of nucleic acids
in molecular diagnostic and/or molecular biology applications. The system is intended for use by
professional users, such as technicians and physicians trained in molecular biological techniques
and the operation of the QIAcube Connect MDx system.
The QIAcube Connect MDx is intended to be used only in combination with QIAGEN and PAXgene
kits indicated for use with the QIAcube Connect MDx for the applications that will be described in
the kit handbooks.
1.3 Requirements for QIAcube Connect MDx users
The table below covers the general level of competence and training necessary for transportation,
installation, use, maintenance, and servicing of the QIAcube Connect MDx.
Task Personnel Training and experience
Delivery No special requirements No special requirements
Installation, routine use and
maintenance
Laboratory technicians or equivalent Appropriately trained and
experienced personnel familiar
with use of computers and
automation in general
Servicing and annual maintenance QIAGEN Field Service Specialists only Trained and authorized by
QIAGEN

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1.4 Glossary
For a glossary of terms used in this User Manual, refer to Section 8.
1.5 Accessories
For information about QIAcube Connect MDx accessories, refer to Appendix B of this User Manual.

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2Safety Information
Before using the QIAcube Connect MDx, it is essential that you read this user manual carefully and
pay attention to the safety information. The instructions and safety information in the user manual
must be followed to ensure safe operation of the instrument and to maintain the instrument in a safe
condition.
Possible hazards that could harm the user or result in damage to the instrument are clearly stated
at the appropriate places throughout this consolidated operating guide.
If the equipment is used in a manner not specified by the manufacturer, the protection provided by
the equipment may be impaired.
The following safety conventions appear throughout this manual:
WARNING
The term WARNING is used to inform you about situations that could result
in personal injury to you or other persons.
Details about these circumstances are given in a box like this one.
CAUTION
The term CAUTION is used to inform you about situations that could result in
damage to the instrument or other equipment.
Details about these circumstances are given in a box like this one.
The advice given in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.
2.1 Proper use
WARNING
Risk of personal injury and material damage [W1]
Improper use of the QIAcube Connect MDx may cause personal injuries or
damage to the instrument. The QIAcube Connect MDx must only be
operated by qualified personnel who have been appropriately trained.
Servicing of the QIAcube Connect MDx must only be performed by a
QIAGEN Field Service specialist.
Perform the maintenance as described in section 6, Maintenance Procedures. QIAGEN charges for
repairs that are required due to incorrect maintenance.

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WARNING Risk of personal injury and material damage [W2]
The QIAcube Connect MDx is too heavy to be lifted by one person. To
avoid personal injury or damage to the instrument, do not lift the instrument
alone.
WARNING Risk of personal injury and material damage [W3]
Do not attempt to move the QIAcube Connect MDx during operation.
CAUTION
Damage to the instrument [C1]
Avoid spilling water or chemicals onto the QIAcube Connect MDx. Damage
caused by water or chemical spillage will void your warranty.
In case of emergency, power OFF the QIAcube Connect MDx at the power switch located in front
of the instrument and unplug the power cord from the power outlet.
CAUTION Damage to the instrument [C2]
Only use QIAGEN spin columns and QIAcube Connect MDx specific
consumables with the QIAcube Connect MDx. Damage caused by use of
other types of spin columns or chemistries will void your warranty.
WARNING
Risk of personal injury and material damage [W4]
Do not use damaged rotor adapters. The rotor adapters can only be used
once. High g forces exerted in the centrifuge can cause damage to re-used
rotor adapters.
CAUTION
Damage to the instrument [C3]
Empty the tip disposal container prior to use to prevent a tip jam in the waste
drawer. Failure to empty the waste container may block the robotic arm that
could cause run failure or instrument damage.
WARNING
Risk of personal injury and material damage [W5]
To prevent plastic crash, load the tubes properly. After a plastic crash, sharp
plastic particles could be inside the centrifuge. Be careful when handling
items inside the centrifuge.
CAUTION
Damage to the instrument [C4]
Only use the correct volume of liquids.
Exceeding the recommended volume of liquids may damage the centrifuge
rotor or instrument.

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WARNING
Risk of fire or explosion [W6]
When using ethanol or ethanol-based liquids on the QIAcube Connect MDx,
handle such liquids carefully
and in accordance with the required safety
regulations. If liquid has been spilled, wipe it off and leave the QIAcube
Connect MDx hood open to allow flammable vapors to disperse.
WARNING
Risk of explosion [W7]
The QIAcube Connect MDx is intended for use with reagents and substances
supplied with QIAGEN kits or other than outlined in respective Information
for use. Use of other reagents and substances may lead to fire or explosion.
If hazardous material is spilled on or inside the QIAcube Connect MDx, the user is responsible for
carrying out appropriate decontamination.
Note: Do not place items on top of the QIAcube Connect MDx hoods.
CAUTION
Damage to the instrument [C5]
Do not lean against the touchscreen when it is pulled out.
2.2 Electrical safety
Note: Disconnect the line power cord from the power outlet before servicing.
WARNING
Electrical hazard [W8]
Any interruption of the protective conductor (earth/ground lead) inside or
outside the instrument or disconnection of the protective conductor terminal is
likely to make the instrument dangerous.
Intentional interruption is prohibited.
Lethal voltages inside the instrument
When the instrument is connected to line power, terminals may be live and
opening covers or removing parts is likely to expose live parts.

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WARNING
Damage to electronics [W9]
Before powering ON the instrument, make sure that the correct supply voltage
is used.
Use of incorrect supply voltage may damage the electronics.
To check the recommended supply voltage, refer to the specifications
indicated in the type plate of the instrument.
WARNING
Risk of electric shock [W10]
Do not open any panels on the QIAcube Connect MDx.
Risk of personal injury and material damage
Only perform maintenance that is specifically described in this user manual.
To ensure satisfactory and safe operation of the QIAcube Connect MDx, follow these guidelines:
The line power cord must be connected to a line power outlet that has a protective conductor
(earth/ground).
Do not adjust or replace internal parts of the instrument.
Do not operate the instrument with any covers or parts removed.
If liquid has spilled inside the instrument, power OFF the instrument, disconnect it from the
power outlet, and contact QIAGEN Technical Services.
If the instrument becomes electrically unsafe, prevent other personnel from operating it, and contact
QIAGEN Technical Services.
The instrument may be electrically unsafe when:
It or the line power cord appears to be damaged.
It has been stored under unfavorable conditions for a prolonged period.
It has been subjected to severe transport stresses.
Liquids come in contact directly with electrical components of the QIAcube Connect MDx.
2.3 Environment
Parameters such as temperature range and humidity range are described in section 9,
Appendix A – Technical data.

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Operating conditions
WARNING Explosive atmosphere [W11]
The QIAcube Connect MDx is not designed for use in an explosive
atmosphere.
CAUTION
Damage to the instrument [C6]
Direct sunlight may bleach parts of the instrument and cause damage to plastic
parts.
The QIAcube Connect MDx must be located out of direct sunlight.
2.4 Biological safety
Specimens and reagents containing materials from humans should be treated as potentially
infectious. Use safe laboratory procedures as outlined in publications such as Biosafety in
Microbiological and Biomedical Laboratories, HHS (www.cdc.gov labs/pdf/CDC-
BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF).
Samples may contain infectious agents. You should be aware of the health hazard presented by
such agents and should use, store, and dispose of such samples according to the required safety
regulations.

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WARNING Samples containing infectious agents [W12]
Some samples used with this instrument may contain infectious agents. Handle
such samples with the greatest of care and in accordance with the required
safety regulations.
Always wear safety glasses, 2 pairs of gloves, and a lab coat.
The responsible body (e.g., laboratory manager) must take the necessary
precautions to ensure that the surrounding workplace is safe, and that the
instrument operators are suitably trained and not exposed to hazardous levels
of infectious agents as defined in the applicable Material Safety Data Sheets
(MSDSs) or OSHA*, ACGIH†or COSHH‡documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
2.5 Chemicals
WARNING Hazardous chemicals [W13]
Some chemicals used with this instrument may be hazardous or may become
hazardous after completion of the protocol run.
Always wear safety glasses, gloves, and a lab coat.
The responsible body (e.g., laboratory manager) must take the necessary
precautions to ensure that the surrounding workplace is safe and that the
instrument operators are not exposed to hazardous levels of toxic substances
(chemical or biological) as defined in the applicable Material Safety Data
Sheets (MSDSs) or OSHA,* ACGIH†or COSHH‡documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
Toxic fumes
If working with volatile solvents or toxic substances, you must provide an efficient laboratory
ventilation system to remove vapors that may be produced.
WARNING Toxic fumes [W14]
Do not use bleach to clean or disinfect the QIAcube Connect MDx. Bleach in
contact with salts from the buffers can produce toxic fumes.
*OSHA : Occupational Safety and Health Administration (United States of America).
†ACGIH : American Conference of Government Industrial Hygienists (United States of America).
‡COSHH : Control of Substances Hazardous to Health (United Kingdom).

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WARNING Toxic fumes [W15]
Do not use bleach to disinfect used labware. Bleach in contact with salts from
the buffers used can produce toxic fumes.
2.6 Waste disposal
Used labware, such as sample tubes, QIAGEN spin columns, filter-tips, buffer bottle and enzyme
tubes, or rotor adapters, may contain hazardous chemicals or infectious agents from the purification
process. These hazardous wastes must be collected and disposed of properly according to local
safety regulations.
For more information about how to dispose of the QIAcube Connect MDx, see section 9.6, Waste
Electrical and Electronic Equipment (WEEE).
WARNING Hazardous chemicals and infectious agents [W16]
The waste may contain toxic material and must be disposed of properly. Refer
to your local safety regulations for proper disposal procedures.
2.7 Mechanical hazards
The hood of the QIAcube Connect MDx must remain closed during operation of the instrument.
Only open the hood when instructed to do so by the instruction for use.
While loading the worktable, always stand clear of the instrument. Do not lean on the worktable
when the robotic arm of the instrument is moving to reach loading position with its lid open. Wait
until the robotic arm completed its movements before you start to load or unload.
WARNING Moving parts [W17]
Avoid contact with moving parts during operation of the QIAcube Connect
MDx. Under no circumstances should you place your hands under the robotic
arm when it is lowering. Do not attempt to move any tip racks or tubes whilst
the instrument is operating.

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WARNING Moving parts [W18]
To avoid contact with moving parts during operation of the QIAcube Connect
MDx, the instrument must be operated with the hood closed.
If the hood sensor or lock
is not functioning correctly, contact QIAGEN
Technical Services.
2.7.1 Centrifuge
Make sure that the rotor and buckets are installed correctly. All buckets must be mounted before
starting a protocol run, regardless of the number of samples to be processed. If the rotor or buckets
show signs of mechanical damage or corrosion, do not use the QIAcube Connect MDx; contact
QIAGEN Technical Services.
CAUTION Damage to the instrument [C7]
The QIAcube Connect MDx must not be used if the centrifuge lid is broken, or
if the lid lock is damaged.
Make sure that no loose material is inside the centrifuge during operation.
Make sure that the rotor is installed correctly and that all buckets are properly
mounted, regardless of the number of samples to be processed. Load the rotor
only as instructed by the software.
Only use rotors, buckets, and consumables designed for use with the QIAcube
Connect MDx. Damage caused by use of other consumables will void your
warranty.
We recommend replacing the centrifuge rotor and buckets after 20,000
cycles, which is equivalent to 9 years of usage with two runs per day for 220
days each year. For more information contact QIAGEN Technical Services.
In case of breakdown caused by power failure, the centrifuge lid can be opened manually to
remove the samples (see section 7.3.2).
WARNING Moving parts [W19]
In case of breakdown caused by power failure, remove the power cord and
wait 10 minutes before attempting to manually open the centrifuge lid.

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CAUTION Damage to the instrument [C8]
After a power failure, do not move the z-module (robotic arm) manually in
front of the instrument. Damage may occur if the QIAcube Connect MDx hood
is closed and collides with the z-module.
WARNING Risk of personal injury and material damage [W20]
Raise the centrifuge lid carefully. The lid is heavy and may cause injury if it
falls.
CAUTION Risk of overheating [C9]
To ensure proper ventilation, maintain a minimum clearance of 10 cm at the
sides and rear of the QIAcube Connect MDx.
Slits and openings that ensure the ventilation of the QIAcube Connect MDx
must not be covered.
2.8 Heat hazard
The QIAcube Connect MDx worktable contains a heated shaker.
WARNING Hot surface [W21]
The shaker can reach temperatures of up to 70°C (158°F). Avoid touching it
when it is hot. Carefully remove the samples after a run.
2.9 Maintenance safety
WARNING/
CAUTION
Risk of personal injury and material damage [W22]
Only perform maintenance that is specifically described in this user manual.

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WARNING
Risk of explosion [W23]
When cleaning the QIAcube Connect MDx with alcohol-based disinfectant,
leave the QIAcube Connect MDx hood open to allow flammable vapors to
disperse.
Only clean the QIAcube Connect MDx when worktable components have
cooled down.
WARNING
Risk of fire [W24]
Do not allow cleaning fluid or decontamination agents to come into contact
with the electrical parts of the QIAcube Connect MDx.
WARNING
Risk of personal injury and material damage [W25]
To prevent the rotor nuts from loosening during operation of the centrifuge,
securely tightened the nuts using the rotor key supplied with QIAcube Connect
MDx.
WARNING
UV irradiation hazard [W26]
A mechanical lock ensures that the hood must be closed for operation of the
UV LED.
If the hood sensor or lock
is not functioning correctly, contact QIAGEN
Technical Services.
WARNING
Risk of personal injury and material damage [W27]
Make sure that lids from spin columns and 1.5 ml microcentrifuge tubes are in
the correct position and pushed all the way down to the bottom of the slots on
the sides of the rotor adapter. Incorrectly positioned lids can break off during
centrifugation.
WARNING
Risk of personal injury and material damage [W28]
Be sure the lid is completely removed from the spin column. Spin columns with
partially removed lids may not be removed properly from the rotor, causing
the protocol run to crash.
CAUTION
Damage to the instrument [C10]
Do not use bleach, solvents, or reagents containing acids, alkalis or abrasives
to clean QIAcube Connect MDx.

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CAUTION Damage to the instrument [C11]
Do not use spray bottles containing alcohol or disinfectant to clean surfaces of
the QIAcube Connect MDx. Spray bottles should be used only to clean items
that have been removed from the worktables.
2.10 Radiation safety
WARNING Risk of personal injury [W29]
Do not expose your skin to UV-C light from the UV LED lamp.
WARNING
Risk of personal injury [W30]
Hazard Level 2 laser light: Do not stare into the light beam when using
handheld bar code scanner.

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2.11 Symbols on the QIAcube Connect MDx
Symbol Location Description
Next to the Shaker Heat hazard – the temperature of the shaker can
reach up to 70ºC (158ºF).
Near the centrifuge; near the robotic arm Mechanical hazard — avoid contact with
moving parts.
On the instrument, near bottle rack Fire hazard – usage of ethanol in bottle rack.
In front of worktable Biological hazard – some samples used with this
instrument may contain infectious agents and
must be handled with gloves.
Inside the waste drawer Biohazard — the waste drawer may be
contaminated with biohazardous material and
must be handled with gloves.
Type plate on the back of the instrument CE mark for European Conformity
Type plate at the back of the instrument CSA listing mark for Canada and the USA
Type plate on the back of the instrument FCC mark of the United States Federal
Communications Commission
Type plate on the back of the instrument RCM mark for Australia and New Zealand
Type plate on the back of the instrument RoHS mark for China (the restriction of the use of
certain hazardous substances in electrical and
electronic equipment)
Type plate on the back of the instrument Waste Electrical and Electronic Equipment
(WEEE) mark for Europe
Type plate on the back of the instrument Legal manufacturer
At the back of the instrument Consult instructions for use
Type plate at the back of the instrument See warnings and precautions
Type plate at the back of the instrument In vitro diagnostic medical device