Braun EXACTFIT 1 Instruction Manual page 7

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.
Guarantee
Consumer Card available on our website at
www.hot-europe.com/after-sales.
For support requests, please visit www.hot-europe.com/after-sales or
find service contact information on the last page of this manual.
Production date is given by the LOT located in the back of the device.
The first 3 numeric digits after the LOT No represent the day of the year of
manufacture. The next 2 numeric digits represent the last two numbers
of the calendar year of manufacture and the letters at the end designate
the manufacturer of the product. E.g. LOT 15614ABC: this product was
made on the day 156, year 2014 at manufacturer with identifier ABC.
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Guidance and manufacturer's declaration – electromagnetic
emissions
The BUA5000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BUA5000 should assure that it is used in such an
environment.
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage fluctuations/
Not applicable
flicker emissions
Non-life support equipment separation distance calculation
(3Vrms / 3V/m compliance)
Separation distance according to
150kHz to 80MHz
Rated maximum output
in ISM bands
power of transmitter (W)
3,5
d = [ ] P
V
1
0.01 0.12
0.1 0.37
1 1.17
10 3.69
100 11.67
Electromagnetic environment –
guidance
The BUA5000 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.
Complies
The BUA5000 is
solely battery powered.
frequency of transmitter (m)
80MHz to 800MHz to
800MHz 2.5GHz
3,5 7
d = [ ] P d = [ ] P
E E
1 1
0.12 0.23
0.37 0.74
1.17 2.33
3.69 7.38
11.67 23.33
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