Guidance And Manufacturer's Declaration - Electromagnetic Emissions - Braun ExactFit 1 Manual De Instrucciones

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
This product conforms to the provisions of the
EC directive 93/42/EEC (Medical Device Directive) .
0297
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
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
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
10
emissions
environment .
Compliance
Group 1 emissions are very low and are not likely to
cause any interference in nearby electronic
Class B
Not applicable
Not applicable
Electromagnetic environment –
guidance
The BUA5000AR uses RF energy only for
its internal function . Therefore, its RF
equipment .
Complies
The BUA5000AR is
solely battery powered .