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10001045 REV B 14
5 WARNINGS ABOUT OTHER MEDICAL TREATMENTS
There are some procedures that should not be performed or are not recommended for patients with the Senza
®
Bluetooth
®
Trial System and there are other procedures which may be possible only with certain precautions.
Patients that need any of these treatments should discuss the treatment with their doctor and other clinicians
(including dentists, physical therapists, occupational therapists) as well as with the medical personnel performing
the procedure.
Procedures that are not recommended for patients if any part of a SCS system is implanted include:
• Diathermy therapy
• Magnetic resonance imaging (MRI) scans
• Computed tomography (CT) scans
• Lithotripsy
• External defibrillation
• Ultrasound procedures
• Radiation
• Radio-Frequency or Microwave Ablation
5.1 Diathermy Therapy
DIATHERMY. A medical treatment in which heat energy from shortwaves, microwaves, or ultrasounds are
used as treatment or in surgery.
Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients
implanted with any part of a neuromodulation system. Energy from diathermy can be transferred through the
implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe
injury or death. The Senza
®
Bluetooth
®
Trial System, whether it is turned on or off, may be damaged.
5.2 Magnetic Resonance Imaging (MRI)
MRI SCAN. A type of technology in which electromagnetic energy is used to take images of soft tissue in the
body.
Patients in the trial phase should not undergo an MRI scan. Refer to the Nevro MRI guidelines manuals (available
at www.nevro.com/physicianmanuals) for detailed information on MRI safety and conditions for MRI scanning of
patients implanted with Nevro products.
Never take the Trial Stimulator and Remote Control into an MRI scan room. The Trial Stimulator and Patient
Remote are not considered safe for MRI and may be rapidly pulled into the MRI scanner. In doing so, they may
strike and injure a person.