Boston Scientific WaveWriter Alpha Informacion Para Medicos página 9

Immunity Test IEC 60601-1-2 Test Level
Electrostatic discharge Air: ± 2 kV, ± 4 kV, ± 8 kV,
(ESD) IEC 61000-4-2 ± 15 kV
Contact: ± 8 kV
Power frequency 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic environment specified below. The
customer or the user of the WaveWriter Alpha or WaveWriter Alpha Prime System should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
(ETS only)
Radiated RF 10 V/m
80 MHz to 2,7 GHz
IEC 61000-4-3
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the WaveWriter
Alpha or WaveWriter Alpha Prime System is used exceeds the applicable RF compliance level above, the WaveWriter Alpha or WaveWriter Alpha
Prime System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the WaveWriter Alpha or WaveWriter Alpha Prime System.
The external electrical components of the WaveWriter Alpha and WaveWriter Alpha Prime Systems have been tested for immunity to interference
from RFID readers per the following specifications.
RFID Spec Per AIM 7351731
ISO 14223
ISO/IEC 14443-3 (Type A)
ISO/IEC 14443-4 (Type B)
ISOAEC 15693 (ISO 18000-3 Mode 1)
ISO 18000-3 Mode 3
ISO/IEC 18000-7
ISO/IEC 18000-63 Type C
ISO/IEC 18000-4 Mode 1
Compliance Level
Air: ± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact: ± 8 kV
30 A/m
Guidance and manufacturer's declaration – electromagnetic immunity
Compliance Level
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM and
amateur radio bands
between 150 kHz
and 80 MHz
10 V/m
80 MHz to 2,7 GHz
Immunity Testing - RFID Readers
Frequency
134.2 kHz
13.56 MHz
13.56 MHz
13.56 MHz
13.56 MHz
433 MHz
860-960 MHz
2.45 GHz
Electromagnetic Compatibility - EN 60601-1-2 Classification Information
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Note: Applies to the external devices.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment . Magnetic fields
from common appliances are not expected to affect
the device.
Electromagnetic Environment - guidance
Professional healthcare facility environment and home healthcare
environment.
Professional healthcare facility environment and home healthcare
environment.
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the compliance level
a
in each frequency range. Interference may occur in the vicinity of
equipment marked with the symbol shown below:
Test Level (RMS)
65 A/m
7.5 A/m
7.5 A/m
5 A/m
12 A/m
3 V/m
54 V/m
54 V/m
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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