natus XLTEK Protektor32, Instructions For Use Manual

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XLTEK Protektor32 Instructions for Use
17
Declaration of Compliance for IEC 60601-1-2
Table 3 - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Protektor32 is intended for use in the electromagnetic environment specified below. The customer
or the user of the
Protektor32
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The
Protektor32
uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause
any interference in nearby electronic equipment
RF emissions
CISPR 11
Class A The Protektor32 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Warning: This equipment/system is intended for use by healthcare
professionals only. This equipment/system may cause radio
interference or may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures, such as re-
orienting or relocating the Protektor32 or shielding the location.
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 4 - Immunity Test Levels - Enclosure Port
Phenomenon Basic EMC
Standard or Test
Method
Immunity Test Levels – Professional
Healthcare Facility Environment
Electrostatic Discharge IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM Fields IEC 61000-4-3 3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximity Fields from RF
Wireless Communications
Equipment
IEC 61000-4-3 See “Enclosure Port Immunity to RF
Wireless Communications Equipment”
Table below
Rated Power Frequency
Magnetic Fields
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
Table 5 – Immunity Test Levels – Input A.C. Power Port
Phenomenon Basic EMC
Standard
Immunity Test Levels – Professional
Healthcare Facility Environment