Product Info

10001045 REV B 13
• Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent
stimulation, which some patients have described as a jolting or shocking sensation. Although the
unexpected change in stimulation may feel uncomfortable, it does not damage the device or injure the
patient directly. In rare cases, as a result of the unexpected change in stimulation, patients have fallen
and been injured.
Strong electromagnetic fields arising from closeness to electrical equipment such as mobile phones, satellite
phones and radio systems may interfere with the radio communication between the Remote Control and the Trial
Stimulator. Communication can be restored by moving away from the interfering electrical equipment or
repositioning the Remote Control.
WARNING: Use of the Senza
®
Bluetooth
®
Trial System adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, the Senza
®
Bluetooth
®
Trial
System and the other equipment should be observed to verify that they are operating normally.
WARNING: Use of accessories and cables other than those specified or provided by Nevro could result in
increased electromagnetic emissions or decreased electromagnetic immunity of the Senza
®
Bluetooth
®
Trial
System and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 15 cm (6 inches) to any part of the Senza
®
Bluetooth
®
Trial
System, including cables specified by Nevro. Otherwise, degradation of the performance of the Senza
®
Bluetooth
®
Trial System could result.
Electrostatic Discharge (ESD) is another common source of electromagnetic interference. ESD can occur when a
person or object accumulates a static charge. ESD is intensified by low humidity and synthetic materials. If the
battery terminals of the Trial Simulator are exposed to ESD, the device may reset and stop stimulation. To avoid
unintentionally stopping stimulation, do not open the battery compartment while stimulation is ongoing.
4.10 Theft Detectors and Security Screening Devices
Security checkpoints, metal detectors, screening systems at airports, and theft detectors all produce EMI. If
patients must pass through such a system, they should tell the personnel that they have an implanted medical
device and show them their Patient ID Card. Patients may be able to go through the checkpoint without going
through the scanner. If that is not possible, patients should turn the device off and move through the scanner as
quickly as possible.
While some theft detection systems are obvious and are located at store exits, others may be concealed within
the store. If a patient is in a store or other environment and suspect EMI is affecting their device, the patient
should turn off their Senza
®
Bluetooth
®
Trial System and move out of the area. Once the patient is out of the area,
they should check whether therapy is on or off. Before therapy can be turned on, the battery may need to be
replaced in the Trial Stimulator.
Patients that have specific questions about EMI sources should talk to their doctor.