Appendix; Guidance And Manufacturer's Declaration On Electromagnetic Compatibility - Miltenyi Biotec CliniMACS Formulation Unit User Manual

APPENDIX

Guidance and manufacturer's declaration
on electromagnetic compatibility
Risk of improper operation due to increased electromagnetic emissions
or decreased electromagnetic immunity. The use of consumables,
accessories, transducers, and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
EMC compliance with IEC 60601-1-2:2014 (Edition 4) has been attested for the
CliniMACS Formulation Unit and the provided components (see Table A.1).
Guidance and manufacturer's declaration – Electromagnetic emissions
The equipment is intended for the use in the professional facility healthcare
environment. The instrument is not intended to be used near active HF surgical
equipment. The customer or user of the instrument should assure that it is used in
such an environment.
Emissions test
Conducted RF Emissions
CISPR 11
Radiated RF Emissions
CISPR 11
harmonic emissions
IEC 61000-3-2
Voltage fluctuations/Flicker emissions
IEC 61000-3-3
Table A.1: Guidance and manufacturer's declaration – Electromagnetic emissions
Compliance
Group 1, Class A
Group 1, Class A
Class A
Complies (d_max = 4%)
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