Promega Maxwell CSC Instrument User manual

Revised 02/15
TM424
TECHNICAL MANUAL
Maxwell®CSC Instrument
with Version 2.X Software
Operating Manual
InstrucƟons for use of the Maxwell® CSC Instrument,
Model Number AS4000.
This product is for sale in the United States
and Canada Only.
Note: Please ensure that all sealing tape
and any residual adhesive are removed from
the Maxwell® CSC system cartridges before
placing the cartridges into the instrument.

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TM424 · Revised 2/15 www.promega.com
1.Introduction........................................................................................................................... 4
1.A. Maxwell®CSC Instrument Purification Procedure......................................................... 4
1.B. Product Intended Use ................................................................................................. 4
1.C. Product Use Limitations.............................................................................................. 5
1.D. Maxwell®CSC Instrument Features ............................................................................. 5
1.E. Maxwell®CSC Instrument Specifications...................................................................... 5
1.F. Product Components .................................................................................................. 6
1.G. Inspection.................................................................................................................. 6
1.H. Precautions................................................................................................................ 7
1.I. Safety Symbols and Marking........................................................................................ 8
1.J. Environmental Requirements (Operating, Shipping and Storage Conditions) ................ 10
2.Hardware Overview .............................................................................................................. 10
3.Unpacking the Maxwell®CSC Instrument ............................................................................... 12
4.Setting Up the Maxwell®CSC Instrument................................................................................ 13
4.A. Setting Up the Maxwell®CSC Instrument ................................................................... 13
4.B. Setting Up the Tablet PC ........................................................................................... 14
4.C. Switching On the Maxwell®CSC Instrument............................................................... 17
4.D. Shutting Down the Maxwell®CSC Instrument............................................................. 17
4.E. Configuring the Tablet PC.......................................................................................... 19
4.F. Maxwell®CSC User Interface Screens ........................................................................ 23
4.G. Instrument Calibration ....................................................................................34
5.Operating the Maxwell®CSC Instrument ................................................................................ 35
5.A. Preprogrammed Methods.................................................................................35
5.B. Starting a Protocol ..........................................................................................35
5.C. Clean Up..................................................................................................................46
5.D. Running Reports ...................................................................................................... 49
5.E. Sanitizing................................................................................................................. 51
Maxwell®CSC Instrument with
Version 2.X Software Operating
Manual
All technical literature is available at: www.promega.com/protocols/
Visit the web site to verify that you are using the most current version of this Technical Manual.
E-mail Promega Technical Services if you have questions on use of this system: [email protected]

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6.Cleaning and Maintenance..................................................................................................... 52
6.A. General Care ............................................................................................................ 52
6.B. Cleaning the Hardware ............................................................................................. 52
6.C. Dealing with Spills.................................................................................................... 53
7.Troubleshooting ................................................................................................................... 54
7.A. Errors and Warnings ................................................................................................ 55
7.B. Use of a USB Flash Drive........................................................................................... 56
8.Appendix.............................................................................................................................. 57
8.A. Service..................................................................................................................... 57
8.B. Returning the Maxwell®CSC Instrument for Service ................................................... 57
8.C. Repacking the Maxwell®CSC Instrument ................................................................... 57
8.D. Instrument Disposal ................................................................................................. 60
9.Warranties, Service Agreements and Related Products............................................................. 60
9.A. Warranty ................................................................................................................. 60
9.B. Warranty and Service Agreement Options .................................................................. 61
9.C. Related Products ...................................................................................................... 62
10. Certificate of Decontamination........................................................................................... 63

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TM424 · Revised 2/15 www.promega.com
1. Introduction
1.A. Maxwell®CSC Instrument Purification Procedure
The Maxwell®Clinical Sample Concentrator (CSC) Instrument(a) provides automated nucleic acid purifica-
tion for a range of clinical sample types. The Maxwell®CSC Instrument is intended for professional use
only. The purification methods use sample lysis and binding to paramagnetic particles as the primary
separation principle. Up to 16 samples can be prepared in a single run.
The automated steps performed by the Maxwell®CSC Instrument include:
• Sample lysis in the presence of a specially formulated Lysis Buffer
• Binding of nucleic acids to paramagnetic particles
• Washing of the bound target molecules away from other cellular components
• Elution of the product
The instrument is controlled by a graphical user interface running on a tablet PC. The Maxwell®CSC
Instrument has the ability to record and report sample tracking and method run data. A bar code reader is
supplied with the Maxwell®CSC Instrument and is used for starting method runs and capturing bar code
information for samples and reagents. The Maxwell®CSC Instrument provides reports of the data gathered
for instrument operations, and the reports can be printed and exported to an administrator-specified
storage location or a USB drive for transfer to a separate computer. To start a run the user scans the bar
code of the reagent kit to be processed; this selects the appropriate protocol to be run. After entering the
sample tracking information, the user follows the recommended protocol for the Maxwell®CSC kit and
prepares the deck tray of the instrument as instructed. The cartridges are placed into the instrument, and
the method is automatically run. Use of the instrument does not require any special training. However,
training is available as part of Operational Qualification, which is offered separately (see Section 9.B).
1.B. Product Intended Use
The Maxwell®CSC Instrument is intended for use, in combination with Maxwell®CSC reagent kits, as an
in vitro diagnostic (IVD) medical device to perform automated isolation of nucleic acids. The nucleic acid
isolated using the Maxwell®CSC Instrument is suitable for direct downstream analysis by standard
amplification methods. These methods include a variety of polymerase chain reaction (PCR) tests for human
in vitro diagnostic purposes.
The Maxwell®CSC Instrument is not intended for use as part of a specific in vitro diagnostic test. The
Maxwell®CSC Instrument is intended for professional use only. Diagnostic results obtained using the
nucleic acids purified with this system must be interpreted in conjunction with other clinical or laboratory
data.

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1.C. Product Use Limitations
The Maxwell®CSC Instrument is not intended for use with reagent kits other than Maxwell®CSC reagent
kits or with samples other than those defined within the intended use and product limitations of the specific
Maxwell®CSC reagent kit being used.
The user is responsible for establishing performance characteristics necessary for downstream diagnostic
applications. Appropriate controls must be included in any downstream diagnostic applications using
nucleic acids purified using the Maxwell®CSC Instrument.
1.D. Maxwell®CSC Instrument Features
• Easy-to-use and easy-to-maintain system operation
• Standardized nucleic acid sample preparation workflow
• Comprehensive technical support
• System controlled via tablet PC
• Reporting functionality
• Bar code reader included
• Preprogrammed methods for nucleic acid purification
• UV lamp to aid in sanitizing the instrument
1.E. Maxwell®CSC Instrument Specifications
Processing Time: 40–60 minutes (depending on sample type and method)
Number of Samples: Up to 16
Weight: 24.2lb (11kg)
Dimensions (W × D × H): 13 × 13.6 × 11.8 inches (330.2 × 345.2 × 299.7mm)
Power Requirements: 95–240VAC, 50/60Hz, 1.0A
Fuse: 250VAC, 2.5A, time-lag fuse (AC250V, T2.5AL, 5 × 20mm)
UV Bulb: Average lifetime approximately 6,000 hours, length 135.9mm, diameter
16mm, 4W, 0.17A current, 29V, Spectral Peak F 253.7, UV output 0.9W

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TM424 · Revised 2/15 www.promega.com
1.F. Product Components
PRODUCT CAT.#
Maxwell®CSC Instrument AS4000
For In Vitro Diagnostic Use. Includes:
• 1 Maxwell®CSC Instrument
• 1 Tablet PC preloaded with Maxwell®CSC User Interface
• 1 USB cable for connection of the Maxwell®CSC Instrument to the Tablet PC
• 1 Power Cable for Maxwell®CSC Instrument
• 1 Power Cable for Tablet PC
• 1 Maxwell®CSC Deck Tray
• 1 UV Bulb (installed)
• 1 Bar Code Reader
• 1 Tablet PC Holder
• 1 Quick Start Guide
• 1 Setup Guide
• 1 Software USB card for the Maxwell®CSC Instrument
1.G. Inspection
Upon receiving your Maxwell®CSC Instrument, please inspect the package carefully to make sure all
components are present and that the instrument has not been damaged in shipping. If any item is damaged,
contact Promega Technical Services (e-mail: [email protected]). Standard components are shown in
Figure 1.
Figure 1. Maxwell®CSC Instrument. Components shown include: deck tray, power cables, USB cable,
Tablet PC, Tablet PC Holder and Bar Code Reader for the Maxwell®CSC Instrument.
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Deck Tray
Tablet PC
Power Supply
Tablet PC Holder
USB Cable
Tablet PC
Bar Code Reader
Power Cable
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1.H. Precautions
• Important Safety Instructions. Save these instructions.
• This IVD instrument complies with the EMC emission and immunity requirements described in
IEC-61326-2-6 and the safety requirements of IEC 61010-1 and IEC 61010-2-101.
• Changes or modifications to this unit not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.
• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may
cause radio interference, in which case you may need to take measures to mitigate the interference.
• Do not use this device in proximity to sources of strong electromagnetic radiation (e.g., unshielded
intentional RF sources), as these may interfere with the proper operation.
• Do not use this instrument for anything other than its intended use.
• Always disconnect the power before cleaning or performing routine maintenance.
• Do not disassemble unit.
• Ensure cartridges, elution tubes and plungers have been securely inserted in their correct positions and
orientation. Failure to do so may result in damage to the instrument.
• Use only Promega-supplied cartridges, plungers and elution tubes. Do not reuse cartridges, plungers or
elution tubes.
• If the equipment is used in a manner other than that specified by Promega, the protection provided by
the equipment may be impaired.
• Keep hands clear of instrument platform as it moves in and out of the instrument.
• During elution, the heated elution block at the front of the platform becomes very hot. Do not touch.
• To avoid muscle strain or back injury, use lifting aids and proper lifting techniques when removing or
replacing the instrument.
• Equipment can be hazardous due to the use of chemical and biohazardous substances.
• Instrument door should be opened and closed only by using the Maxwell®CSC software. Do not
manually pry the door open or override the door sensor during protocol operation, as it will result in the
protocol being aborted.
• This instrument is intended for use with human samples. Use appropriate personal protective equip-
ment (gloves, safety goggles, lab coat, etc.) for handling and disposing of biohazardous materials.
• Do not attempt to replace the UV lamp. Replacing the UV lamp requires special tools. Contact Promega
Technical Services if the UV lamp needs replacement.
• Do not load any additional software programs on the Tablet PC supplied with Maxwell®CSC Instru-
ment. Additional programs may cause the application to slow down.

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TM424 · Revised 2/15 www.promega.com
1.I. Safety Symbols and Marking
Safety Symbols and Markings
Danger. Hazardous voltage. Risk of electrical shock.
Warning. Risk of personal injury to the operator or a safety
hazard to the instrument or surrounding area.
Warning. Pinch point hazard.
Warning. Hot surface. Burn hazard.
Warning. Biohazard.
Warning. UV light hazard. Do not look directly at the UV light.

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IMPORTANT SAFETY INSTRUCTIONS. SAVE THESE INSTRUCTIONS.
Symbols Explanation
Catalog Number
Serial Number
Manufacturer
Consult your local Promega Representative regarding instrument disposal
CSA Product Certification Mark
C-TICK EMC Compliance Mark
FCC Compliance Marked
KCC Compliance Marked
In Vitro Diagnostic Medical Device

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TM424 · Revised 2/15 www.promega.com
1.J. Environmental Requirements (Operating, Shipping and Storage Conditions)
Power Requirements: 95–240VAC, 50/60Hz, 1.0A
Temperature: 4°C–50°C (shipping/storage), 15°C–25°C (operation)
Humidity: Up to 80% relative humidity, non-condensing
Operating Altitude: <2000 meters
The Maxwell®CSC Instrument is intended for indoor use only. Wipe up spills immediately. To avoid
shortening the expected lifespan of the instrument, install in a location that meets the following criteria:
• Locate on a sturdy, level surface.
• Avoid dusty areas.
• Choose a location that has good air circulation and is not exposed to direct sunlight.
• Avoid noisy electrical power sources (e.g., power generators).
• Do not install in a location where there is large temperature variability or high humidity.
• Do not position the instrument so that it is difficult to unplug from the power source.
• Do not place next to heat sources.
• Do not use near flammable gases or liquids.
• Do not place near other electrically sensitive instruments.
• Connect the Maxwell®CSC Instrument and Tablet PC to an uninterrupted power supply (UPS). This is
to ensure continued operation during brief power outages that otherwise might result in aborted
instrument runs and lost samples.
2. Hardware Overview
Figure 2. Front of Maxwell®CSC Instrument.
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Figure 3. Rear view of the Maxwell®CSC Instrument. The rear of the instrument showing the On/Off
switch, power cable connector, instrument-to-tablet USB communication port and three additional USB
communication ports for peripherals (e.g., Bar Code Reader).
Figure 4. Magnetic assembly components and platform. The hardware components inside the
Maxwell®CSC Instrument. The magnet and plunger bars, which are used for sample processing, and the
platform containing the deck tray are evident.
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TM424 · Revised 2/15 www.promega.com
3. Unpacking the Maxwell®CSC Instrument
Allow 10–15 minutes to unpack and set up the instrument. Choose a location with sufficient space to be able
to see the components and screen.
1. Cut the tape on the flaps of the box to open the shipping box.
2. Open the flaps and remove the accessories box from the packaging (Figure 5).
Figure 5. The accessories box.
3. Remove the upper packing material and carefully remove the instrument from the box (Figure 6).
Figure 6. Remove the upper packing material.
4. Place the instrument on a flat stable surface. Leave at least 7.5 inches (19cm) of clearance in front of
the instrument to allow the instrument door to open without hindrance.
5. Remove the plastic bag from around the instrument.
Save the packaging material in case the instrument needs to be returned for service or repair later.
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4. Setting Up the Maxwell®CSC Instrument
4.A. Setting Up the Maxwell®CSC Instrument
1. Manually open the door of the Maxwell®CSC Instrument, and carefully remove the two foam pieces
from inside the instrument (Figure 7).
Figure 7. Remove the two foam pieces from inside the instrument.
The Maxwell®CSC Instrument door is spring-loaded and will close itself once the foam pieces are
removed from the inside of the instrument.
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TM424 · Revised 2/15 www.promega.com
4.B. Setting Up the Tablet PC
1. Open the accessories box. The Tablet PC, Tablet PC Holder, Bar Code Reader and USB card are con-
tained in the box (Figure 8). The Tablet PC contains the operating software for the instrument.
Figure 8. Contents of the accessories box.
2. Remove the Tablet PC and Tablet PC power cable from the box.
3. Remove the Tablet PC Holder from its packaging, and place it on top or adjacent to the Maxwell®CSC
Instrument (Figure 9).
Figure 9. Tablet PC Holder.
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4. Raise the middle leg of the Tablet PC Holder, and place the Tablet PC on the Tablet PC Holder as
shown in Figure 10.
Figure 10. Tablet PC Holder on top of the Maxwell®CSC Instrument.
5. Connect the Tablet PC power cable and the USB cable to the Tablet PC. Connect the other end of the
Tablet PC power cable to a power outlet. We recommend connecting the Tablet PC to an
uninterruptible power supply.
Figure 11. Tablet PC installed on the Maxwell®CSC Instrument.
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4.B. Setting Up the Tablet PC (continued)
6. Connect the other end of the USB cable to the back of the Maxwell®CSC Instrument (Figure 12).
Figure 12. Connect the Tablet PC to the back of the Maxwell®CSC Instrument.
7. Connect the Maxwell®CSC power cable to the back of the Maxwell®CSC Instrument.
8. Connect the Bar Code Reader to one of the three USB ports on the back of the Maxwell®CSC
Instrument.
Figure 13. Maxwell®CSC Instrument with the Tablet PC and Bar Code Reader installed.
9. The Maxwell®CSC Instrument is now ready to use.
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4.C. Switching On the Maxwell®CSC Instrument
Once all the foam pieces have been removed and the Tablet PC set up, you can connect the instrument to a
power outlet. The power switch is located next to the power cable connection on the back of the instrument.
Ensure that the On/Off switch is in the off position. Plug the power cord into a wall outlet. See Section 1.E.
for power requirements. We recommend connecting the Maxwell®CSC to an uninterruptible power supply.
Switch instrument on using the On/Off switch. Connect the Tablet PC power cord into a wall outlet.
Press the Tablet PC power switch located on the top of the Tablet PC to turn the Tablet PC “ON”. Every time
the software is started, it will perform a self-diagnostic test. The deck, plunger bar and magnetic rod
assembly are moved to check operation.
Figure 14. On/Off Switch.
4.D. Shutting Down the Maxwell®CSC Instrument
Shut Down Instrument
1. Shut down the software by pressing the Xin the upper left corner of the ‘Home’ screen (Figure 15).
2. Shut down the Tablet PC using normal Windows®8 shut down procedure (swipe in from right side of
tablet screen, touch Settings, touch Power, touch Shut Down).
Note: The Tablet PC must be shut down at least once a week to allow Windows®to reset memory
usage.
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4.D. Shutting Down the Maxwell®CSC Instrument (continued)
Figure 15. Maxwell®CSC Home screen.
3. Switch the instrument “OFF” using the On/Off switch. Unplug the instrument. If you need to store the
instrument, switch the instrument “OFF”, unplug the instrument and store in a place that meets the
environmental requirements described in Section 1.J.
Storing the Tablet PC
When not in use for a prolonged period of time, the Tablet PC should be shut down and unplugged.
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4.E. Configuring the Tablet PC
The Maxwell®CSC Tablet PC touch screen allows the user to select options. Most screens contain a series of
options. Selections may be made by touching the appropriate option on the tablet PC screen.
Your IT department or site Administrator should configure the Tablet PC according to the IT rules and IT
procedures pertinent to your site. The following is a set of guidelines for your IT personnel or site.
Administrator. Depending on your institution’s IT policy, you may or may not be able to configure or
change the settings for the Tablet PC. Do not load other programs on the tablet as these may interfere with
instrument operation.
The first time you use the Maxwell®CSC Instrument and Tablet PC you should check the configuration of
the following options. Settings can be changed later if required by following these instructions again.
Touch Screen
The Maxwell®CSC Tablet PC has a touch screen and is based on the Microsoft Windows®operating system.
Windows®8 conventions are used throughout the Maxwell®CSC software and can be used to navigate to
the various screens. Touching and holding on the tablet screen for 3 seconds is equivalent to a Right Click
on a normal PC.
Date and Time
The date and time set on the Tablet PC are used for the instrument run log to indicate when a protocol was
run on the Maxwell®CSC Instrument.
1. Swipe in from the right screen edge and select the Windows®8 “Settings” icon. Select Control Panel
(or type “control panel” in the Search tool if you do not see ‘Control Panel’).
2. In the ‘Control Panel’ menu touch the Date and Time menu item.
3. First set your time zone by touching the Change time zone button.
4. On the ‘Time Zone Settings’ window select the appropriate time zone for your location and whether
you wish the clock to automatically adjust for Daylight Savings Time.
5. Touch the OK button to save the time zone settings.
6. You will be returned to the ‘Date and Time Settings’ window.
7. On the ‘Date and Time’ window touch the Change Date and Time button.
8. Set the appropriate date and time for your current location using the calendar and clock setting icons.
9. Touch the OK button to save the date and time settings.
10. You will be returned to the ‘Date and Time Settings’ window. Touch the OK button on this window to
return to the ‘Control Panel’.
11. Close the ‘Control Panel’ by touching the red Xbutton in the upper right corner of the screen.
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4.E. Configuring the Tablet PC (continued)
User Password and Setup
Maxwell®CSC software supports the following user roles.
PromegaAdministrator: PromegaAdministrators have the following capabilities:
• All PromegaUser capabilities
• Import/Delete purification methods
• Specify sample tracking requirements
• Set software options
• Determine UV sanitization options
PromegaUser: PromegaUsers have the following capabilities:
• Select and run preloaded methods
• View and export results
Assigning User Accounts to Promega Groups
The Maxwell®CSC User Interface employs the Windows®login user access levels as a security tool for
adding approved users and associated passwords. New user accounts should be created based on policies
governing your site. Only someone with an Administrator account can assign users to Promega groups. You
have to close the Maxwell®CSC software to create user accounts.
1. Swipe in from the right edge of the screen and select Search, then type in “lusrmgr.msc” and press
Enter.
2. In the left pane of the Computer Management window select Local Users and Groups, and tap
Groups.
Note: If the Local Users and Groups menu item is not visible, select the System Tools item to expand
that menu heading.
Figure 16. Selecting Groups from Computer Management Screen.
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