Roche MagNA Pure Compact Instrument User manual

MagNA Pure Compact Instrument
Addendum 5 to Operator’s Manual, Version 1.3
Software Version 1.1 July 2016
For general laboratory use.

3
MagNA Pure Compact Instrument – Addendum 5 to Operator’s Manual, Version 1.3
Updated Information about the
MagNA Pure Compact System
Dear Valued User of the MagNA Pure Compact System,
Please be informed that Section III, Declaration of Conformity is replaced by the following
section:
Approvals
The MagNA Pure Compact System meets the requirements laid down in:
Directive 2014/30/EU of the European Parliament and Council of 26 February 2014 relating
to electromagnetic compatibility (EMC).
Directive 2014/35/EU of the European Parliament and Council of 26 February 2014 relating
to electrical equipment designed for use within certain voltage limits.
Compliance with the applicable directive(s) is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
Complies with the provisions of the applicable EU directives.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.
Equipment de Laboratoire /
Laboratory Equipment
‘Laboratory Equipment’ is the product identifier as shown on the type
plate.
Updated Information about the MagNA Pure Compact System

If you have any questions regarding the MagNA Pure Compact System Instrument,
please contact your Roche Diagnostics representative.
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2013 Roche Diagnostics
0805521100110716
For general laboratory use.
MAGNA PURE, LIGHTCYCLER, AND TAQMAN are trademarks of Roche.

MagNA Pure Compact Instrument
Addendum 4 to Operator’s Manual, Version 1.3
Software Version 1.1 November 2013
For general laboratory use.

3
Addendum 4 to Operator’s Manual, Version 1.3
Updated Information for the
MagNA Pure Compact Instrument
Dear Valued User of the MagNA Pure Compact Instrument,
This addendum is to inform you that the floppy disk drive for the MagNA Pure Compact
Instruments has been removed for serial numbers starting with MPCC1550.
If you have any questions regarding the MagNA Pure Compact System, please contact your
Roche Diagnostics representative. To call, write, fax, or email us, visit the Roche Applied
Science homepage at www.roche-applied-science.com and select your home country. Coun-
try-specific contact information will be displayed.
Updated Information for the MagNA Pure Compact Instrument

4MagNA Pure Compact Instrument
Please note the following correction to the MagNA Pure Compact Operator’s Manual:
The floppy disk drive on the MagNA Pure Compact Instruments starting with serial number
MPCC1550 has been removed.
Old Version New Version without Floppy Disk Drive
Updated Information for the MagNA Pure Compact Instrument

5
Addendum 4 to Operator’s Manual, Version 1.3
The MagNA Pure Compact Operator’s Manual is corrected as shown below:
Section Current Version Changes
A 3.3.1
8 Disk Drive
(p 24)
8 Disk Drive
The disk drive allows the operator to
store the data generated as well as
transfer it easily to other instruments
or computers (e.g., for sample tracking,
documentation, or troubleshooting).
In addition, new MagNA Pure Compact
purification protocols can be uploaded
from commercially available disks.
Section 8 Disk Drive no longer valid.
A 3.3.4
Sides of the
Instrument
(p 29)
9 USB Ports
There are two USB ports. USB 1 and
USB 2 ports can be used for any
accessories that are not included with
the MagNA Pure Compact Instrument.
9 USB Ports
There are two USB ports. USB 1 and
USB 2 ports can be used for any
accessories that are not included with
the MagNA Pure Compact Instrument.
A USB memory stick allows the
operator to store the data generated or
transfer it easily to other instruments
or computers (e.g., for sample tracking,
documentation, or troubleshooting).
In addition, new MagNA Pure Compact
purification protocols can be uploaded.
B 4
Data Transfer
to or from
the MagNA
Pure Compact
Instrument
(p 67)
The data from the result screen can be
saved to a disk. In future applications
with the LightCycler®System and the
COBAS TaqMan®48 Analyzer, these
data files can be transferred to the
respective instruments.
To save data from the result screen,
use a USB storage device.
Updated Information for the MagNA Pure Compact Instrument

6MagNA Pure Compact Instrument
Section Current Version Changes
B 4.2
Upload of
New Updated
Purification
Protocols
(p 67)
As new or updated purification
protocols are created, they may be
added to the MagNA Pure
Compact Instrument via external data
carrier disks (e.g., software update
disk) during program startup.
Additional protocols will be available
for download from www. magnapure.
com. Follow the download instructions
on this webpage.
To upload new protocols, use a USB
storage device.
Update disks will automatically be
checked for viruses by the instrument
software.
No longer valid.
Workflow:
1. MagNA Pure Compact Instrument
must be shut down.
2. Insert update disk.
3. Switch on instrument.
4. Software is automatically updated.
5. After Main Screen is displayed,
remove update disk.
6. Update complete.
7. The instrument is ready for use.
Workflow:
1. MagNA Pure Compact Instrument
must be shut down.
2. Insert USB.
3. Switch on instrument.
4. Software is automatically updated.
5. After Main Screen is displayed, shut
down the MagNA Pure Compact
Software, remove USB, and start
the MagNA Pure Compact Software
again.
6. Update complete.
7. The instrument is ready for use.
C 5
Documentation
(p 97)
The result screen of the respective run
will be displayed and can be printed or
saved to a disk or LIMS.
To save data from the result screen,
use a USB storage device or save them
directly to a LIMS.
Updated Information for the MagNA Pure Compact Instrument

Published by
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2013 Roche Diagnostics
11113
For general laboratory use.
MAGNA PURE, LIGHTCYCLER, AND TAQMAN are trademarks of Roche.

For general laboratory use.
MagNA Pure Compact Instrument
Addendum 3 to
Operator’s Manual, Version 1.3
Software Version 1.1 August 2012

Information regarding
MagNA Pure Compact Instrument
Dear Valued User of the MagNA Pure Compact Instrument,
Roche Diagnostics Ltd. has merged into Roche Diagnostics International Ltd and therefore
the company name has changed to
Roche Diagnostics International Ltd
In order to harmonize and improve our support, the legal manufacturer changes as follows:
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
If you have any further questions regarding this matter, please do not hesitate to contact your
Roche Diagnostics representative. To call, write, fax, or email us, visit the Roche Applied Science
home page, http://www.roche-applied-science.com and select your home country.
Country-specific contact information will be displayed.
The address of the legal manufacturer in section
“Prologue/Contact Addresses” changes as follows:
Old adress New adress
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
MAGNA PURE is a trademark of Roche.
For general laboratory use. ©2012 Roche Diagnostics.
All rights reserved.
06845070001 a0812

Versatile Nucleic Acid Purification -
Smart. Small. Simple
Information regarding the
MagNA Pure Compact Instrument
Operator’s Manual Version 1.3
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Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
2
Dear valued user of the
MagNA Pure Compact Instrument,
With this document Roche Applied Science releases information on safety standards to provide a maximum of
health and environment assurance. Please read the following information carefully, which updates information
given in the MagNA Compact Instrument Operator’s Manual.
If you have any further questions regarding this matter, please do not hesitate to contact our Technical Services
Department at your best convenience. To call, write, fax, or email us, visit the Roche Applied Science home page,
http://www.roche-applied-science.com and select your home country. Country-specific contact information
will be displayed.
New Prologue Chapters:
Warnings and Precautions
In an emergency, immediately turn the power switch off and unplug the Instrument.
This Instrument is an electromechanical device, that could cause electrical shock or injury if not operated
according to the procedures in this Operator’s Manual.
Disposal Recommendations
All electrical and electronic products should be disposed off separately from the municipal waste system. Proper
disposal of your old appliance prevents potential negative consequences for the environment and human health.
The Instrument must be treated as biologically contaminated-hazardous waste. Decontamination
(i.e., a combination of processes, including cleaning, disinfection and/or sterilization) is required
before reuse, recycling, or disposal.
Dispose of the Instrument according to local and/or labor regulations.
For more information, contact your local Roche representative.
Components of your Control Unit, such as the computer, monitor, keyboard etc., which are marked
with the crossed-out wheeled bin symbol are covered by the European Directive 2002/96/EC on
waste electrical and electronic equipment (WEEE) of the European Parliament and the Council of
27 January 2003.
These items must be disposed of via designated collection facilities appointed by government or
local authorities.
For more information about disposal of your old product, please contact your city office, waste
disposal service or your local Roche representative.
Constraint
It is left to the responsible laboratory organization to determine whether control unit components are
contaminated or not. If contaminated, treat in the same way as the Instrument.
MagNA Pure Compact Instrument Operator’s Manual - 2nd Addendum
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Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
Symbols used in the Manual, page 8
Current Version
Symbol Heading Description
WARNING
RISK OF DANGER
This symbol is used to indicate that noncompliance with instructions or
procedures may lead to physical injury or even death or could cause
damage to the instrument.
HOT SURFACE This symbol is used to label potentially hot instrument surfaces.
BIOHAZARD This symbol is used to indicate that certain precautions must be taken
when working with potentially infectious material.
IMPORTANT NOTE This symbol is used to bring your attention to an important annotation.
INFORMATION NOTE Designates a note that provides additional information concerning the
current topic or procedure.
Additional Information:
Symbol Heading Description
WEE Electrical and electronic equipment marked with this symbol are covered
by the European directive WEEE.
The symbol denotes that the equipment must not be disposed off in the
municipal waste system.
General Information, page 11
Current Version Additional Information
Electrical
Safety
General Information:
Protection Class I
The MagNA Pure Compact Instrument is designed in accordance
with Protection Class I (IEC). The chassis/housing of the Instru-
ment is connected to protection earth (PE) by means of a cable. For
protection against electrical shock hazards, the Instrument must be
directly connected to an approved power source, such as a three-wire
grounded receptacle for the 230V line. Where an ungrounded receptacle
is encountered, a qualified electrician must replace it with a properly
(PE) grounded receptacle, in accordance with the local electrical code.
An extension must not be used. Any break in the electrical ground path,
whether inside or outside the Instrument, could create a hazardous
condition. Under no circumstances should the user attempt to modify
or deliberately defeat the safety features of this Instrument. If the power
cord becomes cracked, frayed, broken, or otherwise damaged, it must be
replaced immediately with the equivalent part from Roche Diagnostics.
All peripheral devices that are connected to the MagNA Pure Compact
Instrument must comply with safety standard IEC 60950 for information
technology equipment, or with IEC 61010-1, UL 61010-1 for laboratory
instruments.
MagNA Pure Compact Instrument Operator’s Manual - 2nd Addendum
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Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
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Setup, page 16
Current Version Additional Information
Selecting a
Location
The MagNA Pure Compact Instrument requires
very little setup. Choose for the MagNA
Pure Compact Instrument a clean, dry, level,
stable surface within 3 m of a compatible
electrical outlet. To ensure proper ventilation,
leave 10 cm of space behind the instrument and
15 cm at each side of the instrument. No space is
needed at the back of the instrument.
To carry the instrument, place your hands under
the base of the instrument. For this purpose, the
instrument base plate provides four recessed
carrier grips. The weight of the MagNA Pure
Compact Instrument is approx. 60 kg, ensure that
enough manpower is available for transportation.
Description of the Instrument, page 22
Current Version Additional Information
UV Light
Protection
The door permits a good view of the interior of
the instrument. During the decontamination
cycle, the door prevents escape of UV light from
the interior.
The Front Door is impervious to UV light from
inside the Instrument, in case the decontamina-
tion function is activated, but permits good view
to the inside of the Instrument. However do not
look at the UV source directly.
Locking of the door is controlled by the software.
Movement of the Robotic Arm is only possible
after the Instrument Door is closed and locked.
Description of the Instrument, page 29
Current Version Additional Information
Socket
for power
cable
This is the plug-in for the power cable. There
are two power cables included in the instrument
package, one for US and one for German wall
outlets.
Always connect the Instrument to a grounded
wall outlet.
Performing a Purification Run, page 43
Current Version Additional Information
For kit specific details regarding the handling of
Reagent Cartridges, please see the correspond-
ing pack insert of the kit.
Reagents might be flammable. For kit spe-
cific details regarding the handling of Reagent
Cartridges, please consult the package insert of
the respective reagent kit for further information.
Cleaning, page 81
Current Version Additional Information
The surface of the MagNA Pure Compact
Instrument as well as removable internal parts
should be cleaned on a weekly basis with a lint
free cloth moistened with deonized water. If a
spill of reagents occurs, the instrument should
be cleaned with a 70% ethanol solution or any
acceptable PCR laboratory cleaner. Turn the
instrument power Off and disconnect or unplug
the power cord before cleaning the instrument.
Mixtures of water and ethanol, that contain
70% ethanol, are highly flammable.
MagNA Pure Compact Instrument Operator’s Manual - 2nd Addendum
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Information regarding the
MagNA Pure Compact Software Update 1.1.2
Versatile Nucleic Acid Purification -
Smart. Small. Simple
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Information regarding the MagNA Pure Compact Software Update 1.1.2
Information regarding the
MagNA Pure Compact Software Update 1.1.2
Please read the following information, which updates information given in the MagNA Pure
Compact Instrument Operator’s Manual!
Dear valued user of the MagNA Pure Compact Instrument,
In March 2009, Roche Applied Science introduced an updated version of the MagNA Pure
Compact Software: Version 1.1.2.
This latest version:
䉴fixes some bugs, found in previous versions
䉴improves some of the text messages
䉴updates the start up functions of the instrument, including the Plausibility Check
䉴improves tip handling
䉴includes updated and improved protocols; a list of installed protocols has also been
implemented in the Maintenance Menu
䉴improves Sample Ordering
䉴includes a Create Problem Report function
If you have any further questions regarding this matter, please do not hesitate to contact our
Technical Services Department at your best convenience. To call, write, fax, or email us, visit
the Roche Applied Science home page, http://www.roche-applied-science.com and select
your home country. Country-specific contact information will be displayed.
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