Boston Scientific Spectra WaveWriter Informacion Para Medicos página 20

Information for Prescribers
Recommended separation distances between portable and mobile RF communications
equipment and the Spectra WaveWriter Spinal Cord Stimulator System
The Spectra WaveWriter Spinal Cord Stimulator System is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the
Spectra WaveWriter Spinal Cord Stimulator System can help prevent electromagnetic interference by
maintaining a minimum distance of 30 cm between portable and mobile RF communications equipment
(transmitters) and the Spectra WaveWriter Spinal Cord Stimulator System.
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Guidance and Manufacturer's Declaration - electromagnetic emissions - for all ME Equipment
The Spectra WaveWriter SCS System intended for use in the electromagnetic environment specified
below. The customer or user of the IPG should assure that it is used in such an environment.
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
Flicker emissions IEC
61000-3-3
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.
Spectra Wavewriter™ System Information for Prescribers
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and ME Systems
Compliance Electromagnetic Environment Guide
Group 1 The Spectra System WaveWriter SCS 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 B The Spectra WaveWriter SCS System is
suitable for use in all establishments. Including
Class B
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used for
Complies
domestic purposes.