TANBead Maelstrom 8 Autostage, User Manual

Page: 30 / 40

28
19 Appendix
TANBead Nucleic Acid Extraction System Maelstrom 8 Autostage (non-sterile)
19.1 Intended Use:
▪
The M8-H Autostage can be used in combination with the Maelstrom 8 and
TANBead’s Nucleic Acid Extraction Kits to extract DNA/RNA from samples.
▪
The M8-H Autostage can hold the Maelstrom 8 for a stable, precise, and
automated operation.
Safety and EMC Information:
Safety Requirements
▪
The medical device has passed the tests and conformed to the standards of EN
61010-1: 2001, “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 EN
61010-2-101: 2002 “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
IEC 61000
EN 55011:2016