Boston Scientific WaveWriter Alpha - Immunity Test; Immunity Testing - RFID Readers

Electromagnetic Compatibility - EN 60601-1-2 Classication Information
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic environment – guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
Air: ± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact: ± 8 kV
Air: ± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact: ± 8 kV
Floors should be wood, concrete or ceramic tile. If
oors are covered with synthetic material, the relative
humidity should be at least 30 %.
Note: Applies to the external devices.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a typical
commercial or hospital environment . Magnetic elds
from common appliances are not expected to affect
the device.
Guidance and manufacturer’s declaration – electromagnetic immunity
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic environment specied 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 Compliance Level Electromagnetic Environment - guidance
Conducted RF
IEC 61000-4-6
(ETS only)
3 Vrms
150 kHz to 80 MHz
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM and
amateur radio bands
between 150 kHz
and 80 MHz
Professional healthcare facility environment and home healthcare
environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
Professional healthcare facility environment and home healthcare
environment.
Field strengths from xed RF transmitters, as determined by an
electromagnetic site survey,
a
should be less than the compliance level
in each frequency range. Interference may occur in the vicinity of
equipment marked with the symbol shown below:
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures,
objects and people.
a Field strengths from xed 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
xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld 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.
Immunity Testing - RFID Readers
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 specications.
RFID Spec Per AIM 7351731 Frequency Test Level (RMS)
ISO 14223 134.2 kHz 65 A/m
ISO/IEC 14443-3 (Type A) 13.56 MHz 7.5 A/m
ISO/IEC 14443-4 (Type B) 13.56 MHz 7.5 A/m
ISOAEC 15693 (ISO 18000-3 Mode 1) 13.56 MHz 5 A/m
ISO 18000-3 Mode 3 13.56 MHz 12 A/m
ISO/IEC 18000-7 433 MHz 3 V/m
ISO/IEC 18000-63 Type C 860-960 MHz 54 V/m
ISO/IEC 18000-4 Mode 1 2.45 GHz 54 V/m