TANBead Maelstrom 8 Autostage, User Manual

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3
Operation Principle
The M8-H equips eight magnetic rods which can collect and transfer magnetic beads
from one well to another. With the spin tips, suspensions can be mixed by the M8-H
with the adjustable spin speed which is up to 3000 rpm. Purified nucleic acids can be
obtained after the steps of lysis, wash and elute.
Intended Use:
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The M8-H can be used with the TANBead Nucleic Acid Extraction System
Maelstrom 8 Autostage (the M8-H Autostage). This model offers a fully
automated nucleic acid platform.
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The M8-H can be used in combination with TANBead Nucleic Acid Extraction Kit
to extract DNA/RNA from specimen.
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The M8-H can handle magnetic beads for purification of nucleic acid.
Safety and EMC Information:
Safety Requirements
▪
The medical device has passed the tests and conformed to the standards of IEC
61010-1:2010, “Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1: General requirements”.
▪
The medical device has passed the tests and conformed to the standards of IEC
61010-2-101:2015, “Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 2-101: Particular requirements
for in vitro diagnostic (IVD) medical equipment”.
EMC Requirements
▪
The medical device has passed the tests and conformed to the standards of IEC
61326-1:2012 & IEC 61236-2-6:2012, “Electrical equipment for measurement,
control and laboratory use - EMC requirements - Part 2-6: Particular
requirements - In vitro diagnostic (IVD) medical equipment”.
▪
The medical device has passed the tests and conformed to following standards:
EN 61326-1:2013
EN 61326-2-6:2013
EN 61000
EN 62304:2015
IEC 62366-1:2015-02