10
This device conforms to the following standards:
EN 60601-1: Medical electrical equipment –
Part 1: General requirements for safety
EN 1060-1: AMD 1 Non-invasive sphygmomanometers –
Part 1: General requirements
EN 1060-3: Non-invasive sphygmomanometers –
Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems
EN 60601-1-2: Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests
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 the home healthcare environment
0297
This product conforms to the provisions of the
EC directive 93/42/EEC (Medical Device Directive).
This product carries the CE mark and is manufactured in conformity with the
RoHS Directive 2011/65/EU.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
For detailed description of EMC requirements please contact a service
representative (see Package Insert or consult www.hot-europe.com). Portable
and mobile RF communications equipment can aect MEDICAL ELECTRICAL
EQUIPMENT.
This product contains batteries and recyclable electronic waste.
To protect the environment, do not dispose of it in the household
waste, but take it to appropriate local collection points.
Guidance and manufacturer’s declaration – electromagnetic
emissions
The BUA5000AR is intended for use in the electromagnetic environment specied below.
The customer or the user of the BUA5000AR should assure that it is used in such an
environment.
Emissions test Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The BUA5000AR 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.
RF emissions
CISPR 11
Class B Complies
Harmonic emissions
IEC 61000-3-2
Not applicable
The BUA5000AR is
solely battery powered.
Voltage uctuations/
icker emissions
Not applicable
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