Notice To The User Per Industry Canada Radio Standards Specifications - Boston Scientific WaveWriter Alpha Informacion Para Medicos

Information for Prescribers
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The users of the WaveWriter Alpha or WaveWriter Alpha Prime System can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WaveWriter
Alpha or WaveWriter Alpha Prime System as recommended below, according to the maximum output power of the communications equipment.
Proximity Test IEC 60601-1-2 Test Level
IEC 61000-4-3 385 MHz: 27 V/m @ 18 Hz pulse
modulation
450 MHz: 28 V/m @ FM modulation
710 MHz, 745 MHz, 780 MHz: 9
V/m @ 217 Hz pulse modulation
1720 MHz, 1845 MHz, 1970 MHz:
28 V/m @ 217 Hz pulse modulation
IEC 61000-4-3 1720 MHz, 1845 MHz, 1970 MHz:
28 V/m @ 217 Hz pulse modulation
2450 MHz: 28 V/m @ 217 Hz pulse
modulation
5240 MHz, 5500 MHz, 5785 MHz: 9
V/m @ 217 Hz pulse modulation
NOTE: For the frequency bands in this table, use the specified recommended separation distance. The recommended minimum separation
distance of 30 cm between portable and mobile RF communications equipment (transmitters) and the WaveWriter Alpha or WaveWriter Alpha
Prime System apply to all other frequencies within the specified ranges.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

Notice to the User Per Industry Canada Radio Standards Specifications:

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:
1. this device may not cause interference, and
2. this device must accept any interference, including interference that may cause undesired operation of the device.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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Manufacturer's declaration for proximity fields
Compliance Level
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
Electromagnetic Environment Guide
Recommended separation distance d = 30 cm
Recommended separation distance d = 30 cm