Integra Codman CereLink Manual Del Usuario página 33

APPENDIX A: ELECTROMAGNETIC COMPATIBILITY – GUIDANCE AND MANUFACTURER'S
DECLARATIONS
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put
into service according to the EMC information provided in this document.
Portable and mobile RF communications equipment can affect medical electrical equipment.
The use of accessories and cables other than those specified in this document, with the exception of accessories and cables sold by the
Manufacturer of the medical electrical equipment as replacement parts for internal components, may result in increased emissions or
decreased immunity of the Medical Electrical Equipment.
The equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in which it will be used.
TABLE 1: Guidance and Manufacturer's Declaration – Electromagnetic Emissions .
The CereLink ICP Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the ICP
Monitor should ensure that it is used in such an environment. Deviations from emission and immunity environment for this device may
affect its life expectancy.
Emissions test
RF emissions: CISPR 11
RF emissions: CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/flicker
emissions IEC 61000-3-3
TABLE 2: Guidance and Manufacturer's Declaration – Electromagnetic Immunity .
The CereLink ICP Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the ICP Monitor should ensure that
it is used in such an environment. Deviations from emission and immunity environment for this device may affect its life expectancy.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations
on power supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
Compliance Electromagnetic environment – guidance
Group 1 The ICP Monitor 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.
Class A The ICP Monitor 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
Class A
used for domestic purposes.
Complies
IEC 60601 test level
+/- 8kV contact
+/- 2kV, +/- 4kV, +/- 8kV, +/- 15kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
0% UT; 0,5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT; 1 cycle at 0°
70% UT; 25/30 cycles at 0°
3 0 A/m
Compliance level Electromagnetic environment – guidance
+/- 8kV contact; Floors should be wood, concrete or ceramic tile. If floors
+/- 2kV, +/- 4kV, +/- 8kV, are covered with synthetic material, the relative humidity
+/- 15kV air should be at least 30 %.
± 2 kV for power supply lines Mains power quality should be that of a typical
commercial or hospital environment.
± 1 kV for input/output lines
±1 kV Mains power quality should be that of a typical
±2 kV commercial or hospital environment.
0% UT; 0,5 cycle at 0°, Mains power quality should be that of a typical commercial or
45°, 90°, 135°, 180°, 225°, hospital environment. If the user of the ICP Monitor requires
270° and 315° continued operation during power mains interruptions, it
is recommended that the ICP Monitor be powered from an
0% UT; 1 cycle at 0° uninterruptible power supply or a battery.
70% UT; 25/30 cycles
at 0°
30 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
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