Easy@Home EHE019 User Manual page 10

- IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
- ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
- EN 1041 Information supplied by the manufacturer with medical devices
- IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in home healthcare environment
- IEC 62304/ EN 62304 Medical device software - Software life-cycle processes
- IEC 62366/ EN 62366 Medical devices – Application of usability engineering to medical devices
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
Electromagnetic compatibility and FCC compliance statement
●
1) This product needs special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided, and this unit
can be affected by portable and mobile radio frequency (RF) communications equipment.
2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This
may result in incorrect operation of the unit.
3) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation!
4) Caution: This machine should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, this machine should be observed to verify normal operation
in the configuration in which it will be used.
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Guidance and manufacturer's declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below.
The customer of the user of the device should assure that it is used in such an environment.
EMISSION TEST COMPLIANCE
RF emissions
Group 1
CISPR 11
RF emission
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below.
The customer of the user of the device should assure that it is used in such an environment.
IMMUNITY IEC 60601 COMPLIANCE
TEST TEST LEVEL LEVEL
Electrostatic
±6 kV contact ±6 kV contact
discharge (ESD)
±8 kV air ±8 kV air
IEC 61000-4-2
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
The device uses RF energy only for its internal
function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Floors should be wood,
concrete, or ceramic tile.
If floor are covered with synthetic
material, the relative humidity
should be at least 30%.
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