16
17
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
0297
This product conforms to the provisions of the
EC directive 93 /42 / EEC (Medical Device Directive).
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
For detailed description of EMC requirements please contact an authorized local
Service Centre (See Package Insert). Portable and mobile RF communications
equipment can aff ect 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.
Guarantee
Consumer Card available on our website at www.hot-europe.com/after-sales
Please see last page of this manual to fi nd the contact for the Kaz Authorized Service
Center in your country.
Guidance and manufacturer’s declaration – electromagnetic emissions
The ME equipment is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the ME equipment should assure that
it is used in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF Emissions
CISPR 11
Group 1
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.
RF Emissions
CISPR 11
Class B Complies
Harmonic emissions
IEC 61000-3-2
Not Applicable
The ME equipment is
solely battery powered.
Voltage fl uctuations/
fl icker emissions
Not Applicable
Non-Life Support Equipment Separation Distance Calculation
(3Vrms / 3V/m compliance)
Rated maximum output
power of transmitter (W)
Separation distance according to
frequency of transmitter (m)
150 kHz to 80 MHz
in ISM bands
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
d = [
3,5
] P
V
1
d = [
3,5
] P
E
1
d = [
7
] P
E
1
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