Safety Information; Warnings - Boston Scientific WaveWriter Alpha Manual Del Usuario

Safety Information

Warnings

The WaveWriter Alpha System with ImageReady MRI Full Body Technology have been shown through non-
clinical testing to minimize the potential interactions with MRI when the appropriate conditions described in
this manual are followed.
If an MRI scan is performed in a condition other than advised in the MR Conditions of Use section it may
result in serious risks such as tissue damage or severe patient injury.
Only use 1.5T Full Body transmit/receive, Head transmit/receive, or Extremity transmit/receive coils.
RF quadrature only. Hydrogen/proton imaging only: Do not use other transmit/receive coils (eg, linear
coils). Local receive-only coils may be used. Only 1.5T coils have been evaluated.
Gradient Systems: Do not use gradient systems producing gradient slew rates per axis greater than
200 T/m/s because they have not been tested and could cause increased risk of induced stimulation (resulting
in shocking or jolting sensations, discomfort, or pain for the patient) or warming of the neurostimulator.
MRI Mode: MRI Mode must be enabled on the Stimulator before performing an MRI scan. Performing an MRI
scan without MRI Mode enabled may lead to unintended stimulation and patient harm.
Impedance Out of Range: Higher or lower than normal impedances could indicate compromised Stimulator-
Lead integrity. Scanning under these conditions may increase the risk of potential adverse effects listed under
"Potential Interactions with MRI Environment."
Potential Interactions with MRI Environment: During an MRI examination there are potential interactions
with the system that may result in heating, magnetic field effects, induced stimulation, or damage to the
device, requiring its replacement. Following the safety conditions designated in this manual will minimize
potential interactions described in this section.
• Heating – The MRI fields may interact with the Spinal Cord Stimulation System causing warming
of the IPG and Leads. This may cause discomfort, pain, or burns.
• Mechanical effects – The MRI magnetic field may exert force or torque on the Spinal Cord
Stimulation System. Patients may feel a tugging or vibration sensation. Patients with recent
implant incisions may feel surgical wound discomfort.
• Induced stimulation – An MRI may induce energy onto the implanted Leads, potentially causing
unintended or uncomfortable sensations (e.g., tingling, shocking, or jolting).
If these interactions cause the patient discomfort, stop the MRI scan.
Body Temperature: The MRI conditional evaluation has been performed for patients with a typical body
temperature of 37 °C. Elevated body temperature in conjunction with tissue heating caused by an MRI scan
increases the risk of excessive tissue heating, which could cause tissue damage.
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
Safety Information
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