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This appliance conforms to the following standards:
IEC 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 the home
healthcare environment and complies with the requirements of IEC 60601-1-
2(EMC), AAMI/ANSI ES60601-1(Safety) standards. And the manufacturer is ISO
13485 certified.
TABLE 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic
environment - guidance
Radiated emission
CISPR 11
Group 1, class B
The device uses RF
energy only for its internal
function. Therefore, its
emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
Conducted emission
CISPR 11
Group 1, class B
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.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Complies
12.2 Electromagnetic Compatibility
