Roche MagNA Pure Compact Instrument Operator's Manual
MagNA Pure Compact Instrument
Addendum 5 to Operator’s Manual, Version 1.3
Software Version 1.1 July 2016
For general laboratory use.
Updated Information about the MagNA Pure Compact System
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.
MagNA Pure Compact Instrument – Addendum 5 to Operator’s Manual, Version 1.3
3
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.
Updated Information for the MagNA Pure Compact Instrument
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.
Addendum 4 to Operator’s Manual, Version 1.3
3
Updated Information for the MagNA 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
4
MagNA Pure Compact Instrument
Updated Information for the MagNA Pure Compact Instrument
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)
A 3.3.4
Sides of the
Instrument
(p 29)
B 4
Data Transfer
to or from
the MagNA
Pure Compact
Instrument
(p 67)
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.
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.
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.
Section 8 Disk Drive no longer valid.
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.
To save data from the result screen,
use a USB storage device.
Addendum 4 to Operator’s Manual, Version 1.3
5
Updated Information for the MagNA 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.
Update disks will automatically be
checked for viruses by the instrument
software.
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.
To upload new protocols, use a USB
storage device.
No longer valid.
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.
6
MagNA Pure Compact Instrument
Published by
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
©
2013 Roche Diagnostics
1
1113
For general laboratory use.
MAGNA PURE, LIGHTCYCLER, AND TAQMAN are trademarks of Roche.
MagNA Pure Compact Instrument
Addendum 3 to
Operator’s Manual, Version 1.3
Software Version 1.1 August 2012
For general laboratory use.
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
MAGNA PURE is a trademark of Roche.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
06845070001 a 0812
For general laboratory use. ©2012 Roche Diagnostics.
All rights reserved.
Information regarding the
MagNA Pure Compact Instrument
Operator’s Manual Version 1.3
Versatile Nucleic Acid Purification -
Smart. Small. Simple
nd
MagNA Pure Compact Instrument Operator’s Manual - 2
Addendum
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-specifi c 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 offi ce, 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.
2
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
MagNA Pure Compact Instrument Operator’s Manual - 2nd Addendum
Symbols used in the Manual, page 8
Current Version
Symbol Heading Description
WARNING
RISK OF DANGER
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
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
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.
when working with potentially infectious material.
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
All peripheral devices that are connected to the MagNA Pure Compact
The MagNA Pure Compact Instrument is designed in accordance
with Protection Class I (IEC). The chassis/housing of the Instrument 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 qualifi ed 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.
Instrument must comply with safety standard IEC 60950 for information
technology equipment, or with IEC 61010-1, UL 61010-1 for laboratory
instruments.
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
3
MagNA Pure Compact Instrument Operator’s Manual - 2nd Addendum
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.
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.
Description of the Instrument, page 29
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.
The Front Door is impervious to UV light from
inside the Instrument, in case the decontamination 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.
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.
Performing a Purifi cation Run, page 43
Current Version Additional Information
For kit specifi c details regarding the handling of
Reagent Cartridges, please see the corresponding pack insert of the kit.
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.
Always connect the Instrument to a grounded
wall outlet.
Reagents might be fl ammable. For kit specifi c details regarding the handling of Reagent
Cartridges, please consult the package insert of
the respective reagent kit for further information.
Mixtures of water and ethanol, that contain
70% ethanol, are highly fl ammable.
4
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
Information regarding the
MagNA Pure Compact Software Update 1.1.2
Versatile Nucleic Acid Purification -
Smart. Small. Simple
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 fi xes 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-specifi c contact information will be displayed.
Information regarding the MagNA Pure Compact Software Update 1.1.2
2
Important Information regarding the
MagNA Pure Compact Instrument
Operator’s Manual
Versatile Nucleic Acid Purification -
Smart. Small. Simple
Prologue
Important Information regarding the MagNA
Pure Compact Instrument Operator’s Manual
Please read the following information, which updates information given in the MagNA Pure
Compact Instrument Operator’s Manual!
Prologue
Contact Addresses, page 5
Current Version Changes
Manufactured by Roche Instrument Center AG
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Marks of Conformity, page 6
Current Version Changes
The MagNA
Pure Compact
Instrument has
been investigated
according to:
CE – Testing
Information
EN 61326:1997 + A1:1998 + A2:2001
Class B (“Electrical equipment for
measurement, control and laboratory
use – EMC requirements”)
CAN/CSA C22.2 No. 1010.1-92 CAN/CSA C22.2 CSA C22.2.61010.1
The instrument conforms to following
directives as issued by the European
Union according to the Council Directive
89/336/EEC (Electromagnetic Compatibility)
and 73/23/EEC (Electrical equipment for
use within certain voltage limits).
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
EN 61326:2006
Class B (“Electrical equipment for
measurement, control and laboratory
use – EMC requirements”)
The instrument conforms to the
following directives as issued by
the European Union according to
the Council Directive 2004/108/EC
(Electromagnetic Compatibility) and
2006/95/EC (Electrical equipment for
use within certain voltage limits).
Please Note: the sentence “Equipment to be connected must fulfi ll the standards set by IEC 950
(Information security in technical equipment, including electronic business machines).”, should
be disregarded.
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
4
Chapter A
Chapter A:
2. Installation of the Instrument
2.4 Setup, page 16
Current Version Changes
2.4.1
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.
3. Description of the Instrument
3.3.5 MagNA Pure Compact Accessories
7 Barcode Scanner – Scanner Specifi cations, page 33
Current Version Changes
Drop Resistance IEC 68-2-32 Test ED; withstands
repeated drops from 1.8 m onto a
concrete surface
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.
DIN EN 60068-2-32 Test ED;
withstands repeated drops from 1.8 m
onto a concrete surface
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
5
Chapter B
Chapter B:
1. Handling the MagNA Pure Compact Software
1.1 Starting the MagNA Pure Compact Instrument, page 37
Current Version Changes
New Screenshot
1.1 Starting the MagNA Pure Compact Instrument, page 38
Current Version Changes
New Screenshot
1.2 Overview of Main Menu Screen
Table 4: Overview of menu and submenu structure, page 41
Current Version Changes
Maintenance:
Detailed Actions
Maintaining:
Leakage Test
䉴
Counter and Reminder
䉴
Error Log
䉴
O-ring Exchange
䉴
Liquid Waste Discard
䉴
UV Decontamination
䉴
Maintaining:
Leakage Test
䉴
Counter and Reminder
䉴
Error Log
䉴
O-ring Exchange
䉴
Liquid Waste Discard
䉴
UV Decontamination
䉴
Create Problem Report
䉴
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
6
Chapter B
2. Performing a Purifi cation Run, page 45
Current Version Changes
For the MagNA
Pure Compact
RNA Isolation
Kit:
The selection of an appropriate
endogenous IC is of high importance
when developing a quantitative RTPCR assay. The IC is co-amplifi ed with
the target of interest and serves as a
control for several factors: differences
in initial template concentrations
between different samples, sample-tosample variations in the PCR, presence
of PCR inhibitors or the extent of any
RNA degradation. The advantage of
using an endogenous IC is that both
internal control mRNA and target
mRNA is extracted from cells or tissue
and reverse transcribed together.
Commonly used endogenous ICs
include so-called housekeeping gene
mRNAs. (Note that Roche Applied
Science offers several LightCycler®
Housekeeping Gene Sets for the
detection of human housekeeping
genes, incl. G6PDH, HPRT, ALAS,
and _2-microglobulin.) The level
of expression of an appropriate
endogenous IC should not vary
with the experimental conditions or
treatments to be compared.
The selection of an appropriate
endogenous IC is of high importance
when developing a quantitative RTPCR assay. The IC is co-amplifi ed with
the target of interest and serves as a
control for several factors: differences
in initial template concentrations
between different samples, sample-tosample variations in the PCR, presence
of PCR inhibitors or the extent of any
RNA degradation. The advantage of
using an endogenous IC is that both
internal control mRNA and target
mRNA is extracted from cells or tissue
and reverse transcribed together.
Commonly used endogenous ICs
include so-called housekeeping gene
mRNAs. The level of expression of an
appropriate endogenous IC should not
vary with the experimental conditions
or treatments to be compared.
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
7
Chapter C
Chapter C:
1. User Maintenance
1.1 Leakage Test, page 72
Current Version Changes
New Screenshot
1.1 Leakage Test, page 73
Current Version Changes
New Screenshot
New Screenshot
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
8
Chapter C
1.2.2 O-Ring Exchange, page 77
Current Version Changes
New Screenshot
1.2.2 O-Ring Exchange, page 78
Current Version Changes
New Pictures
New Pictures
New Pictures
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
9
Chapter C
New Pictures
New Pictures
Current Version Changes
New Pictures
10
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
Chapter C
1.2.2 O-Ring Exchange, page 79
Current Version Changes
New Pictures
New Pictures
New Pictures
New Pictures
New Pictures
11
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
Chapter C
2. Service Maintenance, page 81
Current Version Changes
Note: Service Maintenance may only be
performed by a Roche Diagnostics
service engineer. Contact your local
Roche representant for maintenance
assistance and for more details on
country-specifi c service contracts.
2. Exchange: Hepa Filter HEPA Filter
Service Maintenance may only be performed by a Roche Diagnostics service
engineer. Contact your local Roche
representative for maintenance assistance and for more details on countryspecifi c service contracts.
3. Cleaning Instructions and UV Decontamination
3.2 UV Decontamination, page 85
Current Version Changes
New Screenshot
12
Important Information regarding the MagNA Pure Compact Instrument Operator’s Manual
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