PANNORAMIC® DESK FLASH DX
ABOUT THESE INSTRUCTION FOR USE
6
INFORMATION FOR USE
–
FOR INVESTIGATIONAL USE ONLY.
THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED.
Declaration of Conformity and Compliance
The product complies with relevant international and national standards and laws.
3DHISTECH Ltd. declares that the product
Pannoramic® DESK FLASH DX
is designed and
produced with consideration of specified requirements according to the ISO13485 Medical
devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2016).
IEC/UL 61010-1:2010
–
“Safety Requirements for Electrical
Equipment for Measurement, Control
and Laboratory Use
–
General requirements”
IEC/UL 61010-2-081:2019
–
“Safety Requirements for Electrical Equipment for Measurement,
Control and Laboratory Use
–
Part 2-081: Particular requirements for automatic and semi-
a
utomatic laboratory equipment for analysis and other purposes”
IEC/UL 61010-2-101:2018
, “Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use
–
Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical e
quipment”
IEC 61326-2-6:2012,
“
Electrical equipment for measurement, control and laboratory use - EMC
requirements - Part 2-6: Particular requirements -
In vitro diagnostic (IVD) medical equipment.”
The
symbol on the Pannoramic®
DESK FLASH certifies that the product fully complies with
Directive 2014/30/EC and has passed the appropriate tests.
There is no further operator (user) action required in case of residual risks.
Further information may be obtained from the manufacturer: