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Sample & Assay Technologies

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

L01052 Rev. 7

Содержание DML 3000

Страница 1: ...y Technologies 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 L01052 Rev 7 ...

Страница 2: ...ents or its method of use may be covered by the following patent and its international counterpart U S 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 ...

Страница 3: ...cal safety 2 4 2 6 Chemical safety 2 4 2 7 Mechanical hazards 2 4 2 8 Symbols 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...

Страница 4: ... 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 ...

Страница 5: ...Contents DML 3000 User Manual Contents 3 FCC Declaration D 1 Index Index 1 ...

Страница 6: ...Contents Contents 4 DML 3000 User Manual This page intentionally left blank ...

Страница 7: ...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 ...

Страница 8: ...nstallation 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...

Страница 9: ...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...

Страница 10: ...esults 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 D...

Страница 11: ...t 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 i...

Страница 12: ...SHA American Conference of Government Industrial Hygienists ACGIH or Control of Substances Hazardous to Health COSHH documents 2 6 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 SDS...

Страница 13: ...th 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 ...

Страница 14: ...onic Equipment WEEE SN Type plate on the back of the instrument Serial 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 ...

Страница 15: ...ion over the microplate An internal microprocessor is used to control the basic functions and communications with the HC2 System PC via a standard RS 232 serial port The performance specifications of the DML 3000 are in the following table Performance measure Specification Spectral sensitivity range 350 650 nm Dynamic range 10 to 5x106 RLU Cross talk Less than 4 0 x 10 5 RLU The most important phy...

Страница 16: ...Functional Description 3 2 DML 3000 User Manual The following is the front view of the DML 3000 ...

Страница 17: ...luminate 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 ...

Страница 18: ...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 ...

Страница 19: ...000 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 ...

Страница 20: ... 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 ...

Страница 21: ...2 System Software reports an open door error A close up view of the optical sensor 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 1 1 ...

Страница 22: ... 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 t...

Страница 23: ... 3 9 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 A view of the opened access door with the plate mask Plate mask 1 1 ...

Страница 24: ... the plate mask which opens approximately 90 degrees View of the plate mask release latch location Plate mask release latch 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 1 1 ...

Страница 25: ...cription DML 3000 User Manual 3 11 the plate mask is closed the microplate locator aligns the microplate properly in the X axis and Y axis View of the microplate locator Microplate locator A1 orienting corner 1 2 1 2 ...

Страница 26: ... 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 ...

Страница 27: ... 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 spec...

Страница 28: ...ly 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 page 6 1 for additional instructions View of transport locks in the home position Transport locks 1 1 1 ...

Страница 29: ...ual 3 15 The transport locks must be used prior to transporting the DML 3000 See Securing the DML 3000 using the transport locks page 6 4 for additional instructions View of the transport locks in the secured position and ready for transport ...

Страница 30: ... 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 View of the power connection and the power switch location Power connection port Power switch 1 2 1 2 ...

Страница 31: ...r Manual 3 17 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 View of the power cord ...

Страница 32: ...of a power adapter other than the one provided with the DML 3000 voids the warranty View of the power adapter 3 15 USB to Serial converter The USB to Serial converter is an external expansion COM port module that converts a USB port on the HC2 System PC to two 9 pin serial COM ports for serial connectivity A USB converter will need to be used if a Rapid Capture System RCS or laboratory information...

Страница 33: ...Functional Description DML 3000 User Manual 3 19 the DML 3000 The USB to Serial converter is optional and supplied with the Personal Computer Country Kit View of the USB to Serial converter ...

Страница 34: ...Functional Description 3 20 DML 3000 User Manual This page intentionally left blank ...

Страница 35: ...x on an even surface One person should be able to unpack the DML 3000 and lift it from the packing box Note Keep the original shipping bag box and foam inserts for future shipping requirements Cut the tape along the shipping box top to the sides of the box Open the shipping box flaps Remove the unpacking instructions Remove the accessories kit Inspect the packaging carefully to make sure all compo...

Страница 36: ...s and lift the DML 3000 and packing foam out of the box Example of removing the DML 3000 from the shipping box Set the DML 3000 on a level surface Remove the packing foam from either side of the DML 3000 View of the packing foam removed from around the DML 3000 ...

Страница 37: ...ew of the DML 3000 in plastic shipping bag Remove the tape on the plastic shipping bag Remove the DML 3000 from the plastic shipping bag discard the 2 desiccant bags in the plastic shipping bag and place the plastic shipping bag into the shipping box ...

Страница 38: ...e DML 3000 View of foam block insert in DML 3000 Foam block insert Remove the foam block insert from the DML 3000 and place it in the shipping box Make sure that the transport locks are in the home position See Transport locks page 3 13 for additional information Store the box plastic bag and foam block insert for later use 1 1 ...

Страница 39: ...0 Place the instrument on a firmly secured benchtop Locate it away from other vibration sensitive instruments such as an analytical balance Place the instrument on a level stable surface near a grounded electrical outlet Allow at least 7 5 cm 3 in of clearance on all sides of the instrument for proper ventilation While operating make sure that the DML 3000 platform does not touch other objects For...

Страница 40: ... back panel Important Only use the power adapter provided with the DML 3000 Use of a power adapter other than the one provided with the DML 3000 voids the warranty A close up view of power connection port Plug the power cord into the power adapter and then plug the power cord into a grounded power source ...

Страница 41: ... HC2 System PC and tighten the lock screws Notes Refer to digene HC2 System Software User Manual for the correct COM port to use with the HC2 System PC If a RCS or LIS is used on the same computer as the DML 3000 then a USB to serial converter will be required The USB to Serial converter is supplied with the Personal Computer Country Kit Refer to digene HC2 System Software User Manual for the corr...

Страница 42: ...Installation 5 4 DML 3000 User Manual Example of the DML 3000 with the HC2 System PC ...

Страница 43: ...Installation DML 3000 User Manual 5 5 Diagram of connecting a DML 3000 with a RCS ...

Страница 44: ...Installation 5 6 DML 3000 User Manual Diagram of connecting a DML 3000 with a LIS ...

Страница 45: ...Installation DML 3000 User Manual 5 7 Diagram of connecting a DML 3000 with a RCS and a LIS ...

Страница 46: ...Installation 5 8 DML 3000 User Manual This page intentionally left blank ...

Страница 47: ... in the digene HC2 System Software indicating the microplate wells to be measured Refer to digene HC2 System Software User Manual for additional information The microplate to be measured has been inserted into the DML 3000 A mechanical test has been performed 6 1 Moving the transport locks to the home position The transport locks must be located in the home position to operate the DML 3000 Use thi...

Страница 48: ...ansport locks in the home position 6 2 Placing a microplate in the DML 3000 Open the access door Press the plate mask release latch to lift the plate mask 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 ...

Страница 49: ...a notched corner in the right rear corner of the plate carrier The microplate locator must retract and the microplate must be flush against the plate carrier Make sure the microplate is not resting on top of the microplate locator Example of the microplate in the plate carrier Close the plate mask ...

Страница 50: ...could impact test results Close the access door 6 3 Securing the DML 3000 using the transport locks Use the transport locks to secure the internal components of the DML 3000 during transport Loosen the red thumb screws of both transport locks Slide the transport lock on the optical head guide rail all the way to the right and tighten the thumb screw Slide the transport lock on the left guide rail ...

Страница 51: ...3000 Decontaminate the DML 3000 See Decontaminating the DML 3000 page 7 9 for additional instructions Open the access door Gently push the plate carrier to the back of the DML 3000 View of the plate carrier pushed to the back of the DML 3000 Place the foam block insert into the space between the plate carrier guide rails If a foam block insert is not available use the transport locks to secure the...

Страница 52: ...of the foam block insert in the DML 3000 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 Once the internal components are secure close the access door Place the DML 3000 in the plastic shipping bag Place the outside foam box inserts on the two sides of the DML 3000 ...

Страница 53: ...iginal cardboard shipping box Example of placing the DML 3000 in the shipping box Place the RS 232 cable power adapter and power cord in the shipping box Note Do place the USB to Serial connector in the shipping box Tape the box securely The DML 3000 is ready for transport ...

Страница 54: ...General Operation 6 8 DML 3000 User Manual This page intentionally left blank ...

Страница 55: ... 0 5 NaOCl Note Industrial bleach contains 10 NaOCl while household bleach contains approximately 5 NaOCl When using industrial bleach prepare a 20 1 mixture of water to bleach When using household bleach prepare a 10 1 mixture of water to bleach The final concentration should be 0 5 CAUTION Damage to the instrument Do not use solvents or abrasive cleaners to clean the DML 3000 7 1 1 Cleaning the ...

Страница 56: ...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 Power OFF the DML 3000 Disconnect the power supply Important Do not attempt to clean the instrument or move the internal components while the in...

Страница 57: ...Maintenance DML 3000 User Manual 7 3 Example of wiping the interior of the plate mask ...

Страница 58: ... DML 3000 User Manual Clean each opening in the plate mask with a foam tipped applicator or cotton swab wrapped in a low lint paper towel moistened with 70 isopropyl alcohol Example of cleaning the plate mask openings ...

Страница 59: ...Maintenance DML 3000 User Manual 7 5 Gently push the plate carrier to the back of the DML 3000 Example of gently pushing the plate carrier ...

Страница 60: ...Maintenance 7 6 DML 3000 User Manual Gently push the optical head from the home position toward the center of the instrument Example of the optical head in the home position ...

Страница 61: ...e of the optical head centered Push up on the left side of the optical mask retainer to detach it from the left pin and then pull the optical mask retainer to the left to detach it from the right pin Example of removing the optical mask retainer ...

Страница 62: ...el moistened with 70 isopropyl alcohol Notes If heavy reagent residue is present the optical mask and optical mask retainer may be soaked for 30 minutes in 70 isopropyl alcohol to dissolve the reagent residue Some abrasion marks may be on the underside of the optical mask This is normal The optical mask is lightly spring loaded and contacts the plate mask and black metal shelf during normal operat...

Страница 63: ...d the interior floor Allow the guide rails and the floor to air dry completely Moisten a low lint paper towel with 70 isopropyl alcohol and wipe the inside of the access door and all other visible interior surfaces not previously cleaned Allow to air dry completely Gently push the optical head all the way to the right to return the optical head to the home position Failure to move the optical head...

Страница 64: ...Maintenance 7 10 DML 3000 User Manual This page intentionally left blank ...

Страница 65: ...ons by disconnecting and reconnecting the cables Make sure the correct COM port is used for the connections Refer to digene HC2 System Software User Manual for additional information Check the serial cabling from the DML 3000 to the computer and make sure the connection is tight Correct the Instrument Type setting in the digene HC2 System Software Refer to digene HC2 System Software User Manual fo...

Страница 66: ...sk not being secure while the microplate is in the DML 3000 Power OFF the DML 3000 Open the access door Reseat the microplate in the plate carrier Close the plate mask Power ON the DML 3000 Click the Cancel button Remeasure the microplate 8 6 Grinding noise or Mechanical Failure message This error may be caused by the buildup of reagent residue on the plate mask optical mask or guide rails Clean t...

Страница 67: ...eight of DML 3000 with access door open 51 cm 20 in Weight 10 kg 22 lbs Operating Conditions Condition Parameter Power requirements Power Adapter 100 240 V AC 50 60 Hz 1 5A Power Requirements DML 3000 24 Vdc 48W Main supply voltage fluctuations Voltage fluctuations are not to exceed 10 of the nominal supply voltage Line frequency variation 3 Hz Air temperature 15 30 C 59 86 F Relative humidity 10 ...

Страница 68: ...0 User Manual Transport conditions Condition Parameter Air temperature 20 C to 60 C 4 F to 140 F in manufacturer s package Storage conditions Condition Parameter Air temperature 20 to 40 C 4 to104 F in manufacturer s package ...

Страница 69: ...the DML 3000 according to your laboratory s policies and procedures As needed and weekly maintenance of DML 3000 As Needed Initial Date Initial Date Initial Date Initial Date Initial Date Initial Date Wipe down the plate carrier and plate mask Archive the data Weekly Wipe down the exterior of the instrument ...

Страница 70: ...Date Initial Date Initial Date Initial Date Initial Date Initial Date Clean the plate mask plate mask openings and the plate carrier Clean the optical mask and optical mask retainer Clean the black metal shelf Clean the guide rails and the remaining interior surfaces of the instrument ...

Страница 71: ...me of disposal helps to conserve natural resources and ensures that the product is recycled in a manner that protects human health and the environment Recycling can be provided by QIAGEN upon request at additional cost In the European Union in accordance with the specific WEEE recycling requirements and where a replacement product is being supplied by QIAGEN free recycling of its WEEE marked elect...

Страница 72: ...Appendix C C 2 DML 3000 User Manual This page intentionally left blank ...

Страница 73: ...ection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that the interference will not occur in a particular installation If this equipment does cause harmful interferenc...

Страница 74: ...Appendix D D 2 DML 3000 User Manual This page intentionally left blank ...

Страница 75: ...rical safety 2 3 FCC declaration D 1 Gas actuator lift arm 3 5 Installation Requirements 1 2 LED status lights 3 3 Maintenance Log B 1 Requirements 1 2 Mechanical hazards Caution 2 4 Message Background too high measurement cancelled 8 2 Communications Failed 8 1 Door is Open 8 2 Erratic Results 8 2 Mechanical Failure 8 2 Microplate locator Caution 2 2 6 2 Operating conditions A 1 Operation Require...

Страница 76: ...Index Index 2 DML 3000 User Manual Waste electrical and electronic equipment C 1 ...

Страница 77: ...Appendix D DML 3000 User Manual 3 This page intentionally left blank ...

Страница 78: ...Index Index 4 DML 3000 User Manual This page intentionally left blank ...

Страница 79: ...Appendix D DML 3000 User Manual 5 This page intentionally left blank ...

Страница 80: ...1058536CS Rev 01 04 2012 Sample Assay Technologies ...

Страница 81: ...ervice de qiagen com Hong Kong techservice hk qiagen com India techservice india qiagen com Ireland techservice uk qiagen com Italy techservice it qiagen com Japan techservice jp qiagen com Korea South techservice kr qiagen com Luxembourg techservice bnl qiagen com Mexico techservice mx qiagen com The Netherlands techservice bnl qiagen com Norway techservice nordic qiagen com Singapore techservice...

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