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6-4. Safety standards
The unit confirms to the following standards:
Manufacturing standard: IEC60601-1
(1) Protection class against electric shock : Class II device
: Internally powered equipment
Protection grade against electric shock : Type BF applied part
(2) Guidance and manufacturer's declaration - electromagnetic emissions and immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
The Smartdop 45 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Smartdop 45 should assume that it is used in such an environment.
Emissions test compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The Smartdop 45 use 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.
RF emissions
CISPR 11
Class A
Harmonic
emissions
IEC61000-3-2
Class A
Voltage
fluctuations/ flicker
emissions
IEC61000-3-3
Complies
The Smartdop 45 is suitable for use in all establishments
other than domestic, and may be used connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes provided the following
warning in needed:
Warning: This equipment/system is intended for use by
healthcare professions only. This equipment/system may
cause radio interference or may be necessary to take
mitigation measures, such as re-orienting or relocating the
Smartdop 45 or shielding the location.
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