Qiagen DML 3000 User manual

Sample & Assay Technologies
DML 3000 User Manual
For use with the digene
®
ybrid Capture
®
2 DNA tests
5000-00031
QIAGEN
19300 Germantown Road
Germantown, MD 20874
U A
QIAGEN GmbH
QIAGEN trasse 1
40724 Hilden
GERMANY
L01052 Rev. 7

Trademarks: QIAGEN
®
, digene
®
, Hybrid Capture
®
, Rapid Capture
®
(QIAGEN Group).
The LumiCheck Plate, its components, or its method of use may be covered by the following
patent and its international counterpart:
U. . Patent No. 6,335,997
Registered names, trademarks, etc. used in this document, even when not specifically marked as
such, are not to be considered unprotected by law.
© 2013-2015 QIAGEN, all rights reserved.

Contents
DML 3000 User Manual Contents-1
Contents
1 Introduction 1-1
1.1 About this manual 1-1
1.2 General information 1-1
1.2.1 Technical assistance 1-1
1.2.2 Policy statement 1-1
1.3 Intended use of the instrument 1-1
1.3.1 Requirements for instrument users 1-2
2 Safety 2-1
2.1 Proper use 2-1
2.2 Electrical safety 2-3
2.3 Environment 2-3
2.4 Waste disposal 2-3
2.5 Biological safety 2-4
2.6 Chemical safety 2-4
2.7 Mechanical hazards 2-4
2.8 ymbols on the instrument 2-5
2.9 Additional symbols used in this user manual 2-6
3 Functional Description 3-1
3.1 LED status lights 3-3
3.2 Access door 3-4
3.3 Gas actuator lift arm 3-5
3.4 Optical sensor 3-6
3.5 Optical head 3-7
3.6 Plate carrier 3-8
3.7 Plate mask 3-9
3.8 Plate mask release latch 3-10
3.9 Microplate locator 3-10
3.10 Detector 3-12
3.10.1 Background signal 3-12
3.10.2 Efficiency 3-12
3.10.3 ensitivity 3-12
3.10.4 Dynamic range 3-12
3.10.5 Linearity 3-13
3.10.6 pectral response 3-13

Contents
Contents-2 DML 3000 User Manual
3.10.7 Understanding cross-talk 3-13
3.11 Transport locks 3-13
3.12 Power connection port and power switch 3-16
3.13 Power cord 3-17
3.14 Power adapter 3-18
3.15 U B-to- erial converter 3-18
4 Unpacking Procedures 4-1
5 Installation 5-1
5.1 Connecting the components 5-1
6 General Operation 6-1
6.1 Moving the transport locks to the home position 6-1
6.2 Placing a microplate in the DML 3000 6-2
6.3 ecuring the DML 3000 using the transport locks 6-4
6.4 Transporting the DML 3000 6-5
7 Maintenance 7-1
7.1 Cleaning the DML 3000 7-1
7.1.1 Cleaning the exterior of the DML 3000 7-1
7.1.2 Cleaning the interior of the DML 3000 7-1
7.2 Decontaminating the DML 3000 7-9
8 Troubleshooting 8-1
8.1 DML 3000 is not responding 8-1
8.2 “Communications Failed” message 8-1
8.3 “Door is Open” message 8-2
8.4 “Erratic Results” message 8-2
8.5 Rattling noise or “Mechanical Failure” message 8-2
8.6 Grinding noise or “Mechanical Failure” message 8-2
8.7 “Background too high, measurement cancelled” message 8-2
Technical Data A-1
DML 3000 Maintenance Log B-1
Waste Electrical and Electronic Equipment (WEEE) C-1

Contents
DML 3000 User Manual Contents-3
FCC Declaration D-1
Index Index-1

Contents
Contents-4 DML 3000 User Manual
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Introduction
DML 3000 User Manual 1-1
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 manual
This user manual provides instructions on using the DML 3000 to measure and
analyze specimens in conjunction with the digene HC2 ystem oftware. Use this user
manual along with the other user manuals provided as part of the digene HC2 ystem
uite.
1.2 General information
1.2.1 Technical assistance
At QIAGEN we pride ourselves on the quality and availability of our technical support.
If you have any questions or experience any difficulties regarding the instrument or
QIAGEN products in general, do not hesitate to contact us.
QIAGEN customers are a valuable source of information regarding our products. We
encourage you to contact us if you have any suggestions or feedback concerning our
products.
For technical assistance and more information, contact QIAGEN Technical ervices or
a local distributor (see back cover).
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 ervices.
1.3 Intended use of the instrument
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 a 96-well microplates are calculated and interpreted according to assay
validation parameters.

Introduction
1-2 DML 3000 User Manual
1.3.1 Requirements for instrument users
The table below shows the level of training and experience required for
transportation, installation, use, maintenance, and servicing of the instrument.
Task Personnel Training and experience
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
ervice QIAGEN Field
ervice employees
or personnel
trained by QIAGEN
Trained, certified, and authorized
by QIAGEN

Safety
DML 3000 User Manual 2-1
2Safety
This manual contains information about warnings and cautions that the user must
follow to safely operate the instrument and to maintain the instrument in a safe
condition.
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.
Before using the instrument, it is essential to read this user manual carefully and to
pay particular attention to any instructions it contains concerning hazards that may
arise from the use of the instrument.
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.
The instructions given in this user manual are intended to supplement, not supersede,
the normal safety requirements prevailing in the user’s country.
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
ervices.
WARNING/
CAUTION
Risk of personal injury and material damage.
Improper use of the DML 3000 may cause personal injuries to the user or damage
to the instrument.
The DML 3000 must only be operated by qualified personnel who have been
appropriately trained.

Safety
2-2 DML 3000 User Manual
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.
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.
WARNING 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.

Safety
DML 3000 User Manual 2-3
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 ystem oftware 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 (UP ) before plugging it into a grounded power source.
2.3 Environment
CAUTION 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 Waste disposal
Wastes may contain certain hazardous chemicals or contagious/biohazardous
materials and must be collected and disposed of properly in accordance with all
national and local health and safety regulations and laws.
For disposal of Waste Electrical and Electronic Equipment (WEEE), see “Appendix C”
page C-1.

Safety
2-4 DML 3000 User Manual
2.5 Biological safety
WARNING Samples could contain infectious agents
ome 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, such as the laboratory manager, must take the necessary
precautions to make sure 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 safety data sheets ( D s),
Occupational afety and Health Administration (O HA), American Conference of
Government Industrial Hygienists (ACGIH), or Control of ubstances Hazardous to
Health (CO HH) documents.
2.6 Chemical safety
WARNING azardous 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 D s.
These are available online in PDF format at www.qiagen.com/safety, where users
can find, view, and print the D for each QIAGEN kit and kit component. For
further information, see the instructions for use provided with the kit.
Vent for fumes and dispose of wastes in accordance with all national and local
health and safety regulations and laws.
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.

Safety
DML 3000 User Manual 2-5
CAUTION 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 instrument
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
CE mark for Europe
Type plate on the back of
the instrument
The IVD Marking indicates that this instrument meets
the requirements of the European Directive relating
to In Vitro Diagnostic Medical Devices (98/79/EC).
Type plate on the back of
the instrument
Mark that indicates the instrument complies with
applicable standards for electrical safety of
laboratory equipment
Type plate on the back of
the instrument
Mark of the United tates Federal Communications
Commission (FCC)
Type plate on the back of
the instrument
C-Tick mark for Australia
(supplier identification N17965)
Type plate on the back of
the instrument
RoH mark for China that indicates the restriction of
the use of certain hazardous substances in electrical
and electronic equipment

Safety
2-6 DML 3000 User Manual
Symbol Location Description
Type plate on the back of
the instrument
Waste Electrical and Electronic Equipment (WEEE)
SN
Type plate on the back of
the instrument
erial number
Type plate on the back of
the instrument
Legal manufacturer
On the back of the
instrument
Consult instructions for use
2.9 Additional symbols used in this user manual
Symbol Description
Catalog number
Authorized representative in the European Community

Functional Description
DML 3000 User Manual 3-1
3Functional 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 HC2 ystem PC via a standard R -232 serial port.
The performance specifications of the DML 3000 are in the following table.
Performance measure Specification
pectral sensitivity range 350–650 nm
Dynamic range 10 to 5x10
6
RLU
Cross-talk Less than 4.0 x 10
–5
RLU
The most important physical parameters for measuring a microplate are:
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

Functional Description
3-2 DML 3000 User Manual
The following is the front view of the DML 3000:

Functional Description
DML 3000 User Manual 3-3
3.1 LED status lights
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.
View of the LED status lights:
Red LED status light Green LED status light
Yellow LED status light
1 3
2
1 2
3

Functional Description
3-4 DML 3000 User Manual
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.
Example of opening the access door:
Access door
1
1

Functional Description
DML 3000 User Manual 3-5
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.
View of the gas actuator lift arm:
Gas actuator lift arm
1
1

Functional Description
3-6 DML 3000 User Manual
3.4 Optical sensor
An optical sensor in the front-center of the DML 3000 measures if the door is open or
closed.
View of the access door opened with the optical sensor in view:
Optical sensor Flag
1 2
1
2