Qiagen DML 3000 User manual

Sample to Insight
November 2022
DML 3000 User Manual
For use with the digene ®Hybrid Capture®2 DNA tests
5000
-00031
QIAGEN
19300 Germantown Road
Germantown MD 20874
USA
QIAGEN GmbH
QIAGEN Strasse 1
40724 Hilden
GERMANY
R1
1128779

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Contents
1Introduction .................................................................................................................................................. 4
1.1 About this user manual......................................................................................................................... 4
1.2General information............................................................................................................................. 4
1.3 Intended use of the DML 3000.............................................................................................................. 5
1.4 Requirements for DML 3000 users ......................................................................................................... 5
1.5 Materials required ............................................................................................................................... 5
1.6 Materials required but not provided....................................................................................................... 5
2Safety Information ......................................................................................................................................... 6
2.1 Proper use .......................................................................................................................................... 6
2.2 Electrical safety ................................................................................................................................... 7
2.3 Environment........................................................................................................................................ 8
2.4 Biological safety.................................................................................................................................. 8
2.5 Chemical safety .................................................................................................................................. 8
2.6 Waste disposal ................................................................................................................................... 8
2.7 Mechanical hazards ............................................................................................................................ 9
2.8 Symbols on the DML 3000 ................................................................................................................... 9
2.9 Additional symbols used in this user manual and instrument box label: .................................................... 11
3General Description .................................................................................................................................... 11
3.1 LED status light .................................................................................................................................. 13
3.2 Access door...................................................................................................................................... 13
3.3 Gas actuator lift arm.......................................................................................................................... 14
3.4Optical sensor................................................................................................................................... 14
3.5 Optical head .................................................................................................................................... 15
3.6 Plate carrier ...................................................................................................................................... 15
3.7 Plate mask ........................................................................................................................................ 16
3.8 Plate mask release latch ..................................................................................................................... 16
3.9 Microplate locator ............................................................................................................................. 17
3.10 Detector ....................................................................................................................................... 17
3.11 Transport locks .............................................................................................................................. 18
3.12 Power connection port and power switch ......................................................................................... 20
3.13 Power cord................................................................................................................................... 20

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3.14 Power adapter .............................................................................................................................. 21
3.15 USB-to-Serial converter ................................................................................................................... 21
4Unpacking Procedures................................................................................................................................. 22
5Installation Procedures ................................................................................................................................. 25
5.1 System delivery and installation........................................................................................................... 25
5.2 Site requirements............................................................................................................................... 25
5.3 Connecting the components................................................................................................................ 25
6General Operation...................................................................................................................................... 31
6.1 Moving the transport locks to the home position .................................................................................... 31
6.2 Placing a microplate in the DML 3000................................................................................................. 32
6.3 Securing the DML 3000 using the transport locks .................................................................................. 33
6.4 Repackaging and transporting the DML 3000 ...................................................................................... 33
7Maintenance .............................................................................................................................................. 36
7.1 Cleaning the DML 3000..................................................................................................................... 36
7.2Decontaminating the DML 3000 ......................................................................................................... 41
8Troubleshooting .......................................................................................................................................... 42
9Appendices................................................................................................................................................ 44
9.1 Technical Specifications ..................................................................................................................... 44
9.2 Legal................................................................................................................................................ 45
9.3 DML 3000 Maintenance Log .............................................................................................................. 47
10 Ordering Information................................................................................................................................... 48
11 Document Revision History ........................................................................................................................... 49

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1Introduction
Thank you for choosing the digene Microplate Luminometer (DML) 3000. We are confident it will become an integral part of
your laboratory.
Before using the instrument, it is essential that you read this user manual carefully and pay particular 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 instructions on using the DML 3000 to measure and analyze specimens in conjunction with the digene
HC2 System Software. Use this user manual along with the other user manuals provided as part of the digene HC2 System Suite.
1.2 General information
1.2.1 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 DML 3000 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.
For technical assistance, contact QIAGEN Technical Services.
Website: support.qiagen.com
When contacting QIAGEN Technical Services about errors, please have the following information ready:
DML 3000 serial number, type, and version
Error code (if applicable)
Timepoint when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Copy of log files
1.2.2 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. In an effort to produce useful and appropriate documentation, we appreciate your
comments on this user manual. Please contact QIAGEN Technical Services.

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1.3 Intended use of the DML 3000
The DML 3000 is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using
chemiluminescence technology in 96-well microplates are calculated and interpreted according to assay validation parameters.
1.3.1 Cybersecurity actions
1. Ensure that only authorized users have access to the computer in which the digene HC2 System Software was installed.
2. An antivirus (malware protection) software shall be installed on the computer where the user installs the application.
3. Only connect trusted hardware and devices to the computer in which the software is installed.
4. Ensure that any exported or printed data is stored appropriately.
5. Backup the file regularly to avoid hard disk failure or ransomware.
1.4 Requirements for DML 3000 users
The table below covers the general level of competence and expertise necessary for transportation, installation, use,
maintenance, and servicing of the DML 3000.
Table 1. Level of competence and expertise required in handling the DML 3000.
Task
Personnel
Level of competence and expertise
Transportation
Approved carrier
Appropriately trained, experienced, and approved by QIAGEN
Installation
Laboratory technicians or equivalent
Appropriately trained, experienced, and familiar with the use
of
computers and automation in general
Routine use
Laboratory technicians or equivalent
Appropriately trained, experienced, and familiar with the use of
computers and automation in general
Maintenance
Laboratory technicians or equivalent
Appropriately trained, experienced, and familiar with the use of
computers and automation in general
Service
QIAGEN Field Service employees or personnel trained by QIAGEN
Trained, certified, and authorized by QIAGEN
1.5 Materials required
Note: Only use accessories supplied by QIAGEN.
DML 3000
Power Adaptor
Power Cords (country specific)
RS-232 Cable
1.6 Materials required but not provided
Lumicheck Plate
Personal Computer (PC)
Laser Printer
USB Printer Cable
digene HC2 System Software

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2Safety Information
Before using the DML 3000, it is essential that you read this user manual carefully and pay particular 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.
The following types of safety information appear throughout the QIAGEN DML 3000 User Manual.
WARNING
The term WARNING is used to inform you about situations that could result in personal injury to you or
others.
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 an instrument or
other
equipment.
Details about these circumstances are given in a box like this one.
The guidance provided in this manual is intended to supplement, not supersede, the normal safety requirements prevailing in
the user’s country.
Please be aware that you may be required to consult your local regulations for reporting serious incidents that have occurred
in relation to the device to the manufacturer and/or its authorized representative and the regulatory authority in which the user
and/or the patient is established.
Note: Operators of this instrument must be trained in both general laboratory safety practices and the safety requirements
specific to the instrument. If the equipment is used in a manner not specified by the manufacturer, the protection provided by
the equipment may be impaired.
2.1 Proper use
Maintain the instrument in good working order. If the instrument has been under adverse conditions such as fire, flood,
earthquake, etc., contact QIAGEN Technical Services.
WARNING
Risk of personal injury and material damage
Improper use of the DML 3000 may cause personal injuries or damage to the instrument.
The DML 3000 must only be operated by qualified personnel who have been appropriately trained.
WARNING Risk of inaccurate test results
The access door must be completely closed during microplate measurement to prevent ambient light
from entering the DML 3000.
Ambient light could impact test results.

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WARNING
Risk of personal injury
Before lifting the DML 3000, position yourself at the
back of the DML 3000. The weight distribution of
the DML 3000 is heavier at the back than at the front.
To prevent injury, bend your knees and lift the DML 3000 slowly to compensate for this weight difference.
CAUTION
Risk of inaccurate test results
Failure to properly maintain the DML 3000 may cause high background, a mechanical error, and/or
irretrievable data loss. Make sure to perform the required maintenance procedures.
CAUTION
Damage to the instrument
Insert the microplate in the DML 3000 so there is no interference from the microplate locator. If
necessary, lift the plate mask 90 degrees to make sure there is no interference.
CAUTION
Damage to the instrument
If the internal components of the DML
3000 are not secured, severe damage to the DML 3000 will
result and the warranty will be voided.
CAUTION
Damage to the instrument
Do not use solvents or abrasive cleaners to clean the DML
3000.
CAUTION
Damage to the instrument
Do not touch the bottom surface of the optical head while removing the mask.
2.2 Electrical safety
Basic electrical hazard awareness is essential for the safe operation of any system. Elements of electrical safety include, but
are not limited to, the following:
Periodically inspect electrical cables in and on the instrument for signs of wear and damage.
Do not disconnect any electrical connection while the instrument is powered ON.
Only qualified personnel should perform electrical servicing.
Use only the provided power cords and electrical accessories to protect against electric shock.
Only connect the power cords to a properly grounded power source.
Do not touch any switches or power source with wet hands.
Power OFF the instrument before disconnecting the alternating current (AC) power cord.
Power OFF and unplug the instrument prior to cleaning up any liquid spills.
Replace all access covers before operating the instrument.
Refer to digene HC2 System Software User Manual for other warnings and precautions related to operating the DML 3000.
For best performance of the DML 3000, plug the DML 3000 into a surge protector or uninterruptible power supply (UPS)
before plugging it into a grounded power source.

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2.3 Environment
WARNING
Damage to the instrument
In greater than 80% high-humidity environments, the DML 3000 must be powered ON at all times to
prevent the buildup of internal condensation.
2.4 Biological safety
WARNING
Samples could contain infectious agents.
Some samples used with this instrument may contain infectious agents. Handle such samples carefully
and in accordance with the required safety regulations.
Always wear a suitable lab coat, disposable gloves, and protective goggles.
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 Safety Data Sheets
(SDSs) or OSHA,* ACGIH†or COSHH‡documents.
* 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).
2.5 Chemical safety
WARNING
Hazardous substances
The products used with this instrument contain hazardous substances.
When working with chemicals, always wear a suitable lab coat, disposable gloves, and protective
goggles. For more information, please consult the appropriate SDSs. These are available online in PDF
format at www.qiagen.com/safety, where users can find, view, and print the SDS for each QIAGEN
kit and kit component. For further information, see the instructions for use provided with the kit.
Venting for fumes and disposal of wastes must be in accordance with all national, state, and local
health and safety regulations and laws.
2.6 Waste disposal
For more information about how to dispose of the DML 3000, see “Waste Electrical and Electronic Equipment (WEEE)” on
page 45.
WARNING
Hazardous chemicals and infectious agents
The waste contains samples and reagents. This waste may contain toxic or infectious material and must
be disposed of properly. Refer to your local safety regulations for proper disposal
procedures.

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2.7 Mechanical hazards
WARNING
Risk of personal injury
Keep hands free of moving parts. Do not reach into the DML 3000 while it is operating.
WARNING
Damage to the instrument
If the DML 3000 is powered ON, the optical head must remain in the home position while the access
door is open.
Attempting to move the optical head when the DML 3000 is powered ON exposes the optical head to
ambient light. Ambient light will damage the optical head.
2.8 Symbols on the DML 3000
The following symbols may appear in the user manual or on the packaging and labelling:
Symbol
Location
Description
Inside the instrument above the plate
carrier
Warning or caution sign
Inside the instrument above the plate
carrier
Biohazard
—the instrument may be contaminated
with biohazardous material and must be handled
with gloves
Type plate on the back of the instrument,
instrument box label and the front cover
of this user manual
CE mark for Europe
Type plate on the
back of the instrument,
instrument box label and the front cover
of this user manual
The IVD Marking indicates that this instrument.
is an
in vitro
diagnostic medical device
Type plate on the back of the
instrument and instrument box label
Mark that indicates the instrument complies with
applicable standards for electrical safety of
laboratory equipment
Type plate on the back of the instrument
and instrument box label
Mark of the United States Federal Communications
Commission
(FCC)
Type plate on the back of the instrument
and instrument box label
C
-Tick mark for Australia
(supplier identification N17965)

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Symbol
Location
Description
Type plate on the back of the instrument
and instrument box label
RoHS mark for China that
indicates the restriction of
the use of certain hazardous substances in electrical
and electronic equipment
Type plate on the back of the instrument
and instrument box label
Waste Electrical and Electronic Equipment
(WEEE)
Type plate on the back of
the instrument
and instrument box label
Serial number
Type plate on the back of the instrument,
instrument box label and the front cover
of this user manual
Legal manufacturer
Type plate on the back of the instrument
and instrument box label
Consult instructions for use
Instrument box label
Fragile, handle with care
Type plate on the back of the instrument
and instrument box label
Global trade item number (GTIN)
Type plate on the back of the
instrument
and instrument box label
Unique device identifier (UDI)
Instrument box label
Relative humidity
Instrument box label
Barometric pressure
Instrument box label
Temperature range
The front cover of this user manual
Material

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2.9 Additional symbols used in this user manual and instrument box label:
Symbol
Location
Description
Type plate on the back of the instrument,
instrument box label and the front cover of
this user manual
Catalog number
The instrument box label and the front
cover of this user manual
Authorized representative in the European
Community
3General Description
The DML 3000 is highly sensitive with a broad dynamic range. It features a low background photon-counting PMT and
measures light in the visible spectrum (350–650 nm).
Microplates are loaded at the front of the DML 3000. The individual microplate wells are sequentially moved beneath the
opening of the detector and then individually measured. A step motor moves the microplate in the Y-direction to present the
microplate wells to the detector. A separate stepper motor moves in the X-direction over the microplate.
An internal microprocessor is used to control the basic functions and communications with the digene HC2 System PC via a
standard RS-232 serial port. The performance specifications of the DML 3000 are summarized in Table 2.
Table 2. Performance specifications of the DML 3000.
Performance measure
Specification
Spectral sensitivity range
350–650 nm
Dynamic
range 10 to 5 x 106RLU
Cross
-talk Less than 4.0 x 10–5 RLU
The most important physical parameters for measuring a microplate are the following:
Reflectivity of the light spectrum measured at the detector
Absorbency of the light between adjacent microplate wells
Homogeneity and reproducibility of the parameters of the detector
Physical dimensions and properties, such as the flatness of the surface
Accuracy and reproducibility of all physical dimensions

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Figure 1. Front view of the DML 3000

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3.1 LED status light
There are three light-emitting diode (LED) status lights on the front panel of the DML 3000: red, yellow, and green. All three
lights illuminate briefly after powering ON the DML 3000.
The red LED status light indicates the DML 3000 is not operational. The yellow LED status light remains lit, unless the DML 3000
is performing a function as directed by the software. The green LED status light indicates the DML 3000 is powered ON.
Figure 2. View of the LED status lights. (1): Red Led status light (2): Yellow Led status light (3): Green Led status light
3.2 Access door
The access door is on the top of the DML 3000. It allows access to the plate mask and plate carrier. To open the door, lift the
lower front edge.
Figure 3. Opening the access door of the DML 3000
1
1
1
1
2
3

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3.3 Gas actuator lift arm
The gas actuator lift arm supports the access door when it is opened and allows the access door to close evenly and smoothly.
Figure 4. View of the gas actuator lift arm
3.4 Optical sensor
An optical sensor in the front-center of the DML 3000 detects if the door is open or closed.
Figure 5. View of the optical sensor when the access door is opened. (1): Optical sensor (2): Flag
If the access door is not completely closed, the optical sensor does not detect the flag and the digene HC2 System Software
reports an open door error.
1
2

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Figure 6. Close-up view of the optical sensor
3.5 Optical head
The optical head measures the chemiluminescence of each microplate well. The optical head has an optical mask and an
optical mask retainer. The optical mask isolates one microplate well from the other microplate wells so that the DML 3000 can
measure only that one microplate well. The optical mask retainer maintains the position of the optical mask.
Figure 7. Close-up view of the optical head. (1): Optical head (2): Optical mask (3): Optical mask retainer
3.6 Plate carrier
When a 96-well microplate is placed in the DML 3000 for measurement, the plate carrier keeps the microplate positioned
securely against the plate mask. The spring-loaded base of the plate carrier pushes the microplate up into the plate mask for
a tight fit. Once the microplate is placed inside the plate carrier and the plate mask is closed, the springs provide a light
upward pressure to secure the microplate in place.
The A1 corner is located in the back-right location. The A1 label acts as a visual aid to help properly position the microplate.
1
3
2

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3.7 Plate mask
The plate mask is a metal cover with 96 holes aligned to the wells of a microplate. The plate mask is designed to minimize
cross-talk between microplate wells.
Figure 8. View of the plate mask when the access door is opened
3.8 Plate mask release latch
The plate mask release latch is used to open the plate mask, which opens approximately 90 degrees.
Figure 9. View of the plate mask release latch

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3.9 Microplate locator
The back-right corner of the plate carrier has a microplate locator that retracts when the plate mask is open to allow the
microplate to be placed in the plate carrier. When the plate mask is closed, the microplate locator aligns the microplate
properly in the X--axis and Y--axis.
Figure 10. View of the microplate locator. (1): Microplate locator (2): A1 orienting corner
3.10 Detector
The DML 3000 uses a single PMT to measure chemiluminescence of the microplate wells on a 96-well microplate. It leverages
both photon-counting and current-measurement modes to optimize the dynamic range of the DML 3000.
A light detector using a PMT can be characterized by the following parameters:
Background signal
Efficiency
Sensitivity
Dynamic range
Linearity
Spectral response
2
1

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3.10.1 Background signal
The background signal can be divided in two components:
A constant (baseline) component
A statistically variable (noise) component that is different for each individual measurement
The background signal in the photon-counting mode is automatically checked at the start of each microplate measurement. In
the current-measurement mode, used at high RLU levels, the background level is subtracted from each reported measurement.
3.10.2 Efficiency
Efficiency is the response (detector output signal) versus the input signal (light intensity). Efficiency is the gradient of RLU versus
gradient of light intensity.
3.10.3 Sensitivity
Sensitivity is related to both background signal and efficiency. Sensitivity is directly proportional to efficiency and the
background signal is inversely proportional (higher background results in lower sensitivity).
Sensitivity describes the lowest intensity of light that can be detected as different from background. Sensitivity is usually measured
using the amount of a luminescent substance the DML 3000 is able to detect and clearly distinguish from background noise.
3.10.4 Dynamic range
Dynamic range is the relationship between the lowest and the highest signal that the detector is able to quantify. The dynamic
range for the DML 3000 is 10 to 5 x 106RLU.
3.10.5 Linearity
Linearity describes the change of output signal, the RLU, related to the change of input signal (i.e., light intensity). The detector
is linear if the change of output signal is of the same factor as the input signal change. For example, if light intensity is doubled,
the output signal should also double.
3.10.6 Spectral response
Spectral response describes the relationship between the efficiency of the PMT versus the wavelength of light measured. The
photomultiplier tube used has a spectral response of 350–650 nm.
3.10.7 Understanding cross-talk
Cross-talk is the amount of light that is measured in one microplate well that is emitted from a neighboring microplate well. In
contrast to the parameters of the detector, cross-talk is not a parameter of the detector itself.
Cross-talk is related to the construction of the optical path between the detector and the microplate surface, especially how this
path is shielded against detecting light from adjacent specimens. It is very much dependent on the microplate design and
material itself and not solely a DML 3000 parameter.
3.11 Transport locks
The transport locks are used to secure the internal components of the DML 3000 when the instrument is being transported.

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The DML 3000 is shipped from QIAGEN with the transport locks in the home position. The foam-block insert secures the plate carrier
and optical head during transport. The transport locks are only used for transport when the foam-block insert is not available.
If the transport locks are not in the home position, see ”Moving the transport locks to the home position” on page 31 for
additional instructions.
Figure 11. View of the transport locks in the home position
The transport locks must be used prior to transporting the DML 3000. See “Securing the DML 3000 using the transport locks"
on page 33 for additional instruction.
Figure 12. View of the transport locks in the secured position and ready for transport

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3.12 Power connection port and power switch
Located at the back-left of the DML 3000, the power connection port is where the power adapter plugs into the DML 3000.
The power switch powers the DML 3000 ON and OFF.
Figure 13. View of the power connection and the power switch. (1): Power connection port (2): Power switch
3.13 Power cord
The power cord connects to the power source at one end and the power adapter at the other. For the best performance of the
DML 3000, connect the power cord to a surge protector or an UPS.
Figure 14. View of the power cord
2
1