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 affect 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 specified 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 fluctuations/
flicker emissions
Not applicable