Braun VitalScan 1 Manual page 10

Internally Powered Equipment
Continuous Operation
IP22: Protected against solid foreign objects of 12.5 mm diameter and greater.
Protected against vertically falling water drops when the device is tilted up to 15°
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 1060-4: Non Invasive Sphygmomanometers
Part 4: Test Procedures to Determine the Overall System Accuracy of Automated
Non-Invasive Sphygmomanometers
AND
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
AND
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
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
For detailed description of EMC requirements please contact a service representative.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
Please do not dispose of the product in the household waste at the end
of its useful life. Disposal can take place at your local retailer or at
appropriate collection points provided in your country.
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Guidance and manufacturer's declaration – electromagnetic emissions
The ME equipment is intended for use in the electromagnetic environment specified
below. The customer or the user of the ME equipment 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)
150 kHz to 80 MHz
in ISM bands
3,5
Rated maximum output d = [
V
power of transmitter (W) 1
0.01 0.12
0.1 0.37
1 1.17
10 3.69
100 11.67
Electromagnetic environment – guidance
The ME equipment 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 ME equipment is
solely battery powered.
Separation distance according to
frequency of transmitter (m)
80 MHz to 800 MHz to
800 MHz 2.5 GHz
3,5
] P d = [ ] P d = [
E
1
0.12
0.37
1.17
3.69
11.67 23.33
7
] P
E
1
0.23
0.74
2.33
7.38
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