Product Info

10001045 REV B 20
6.12 Post-Operative Pain
In the days after the surgery, patients may experience pain in the implant area. This is typical in SCS surgeries.
6.13 Infection
If a patient experiences persistent discomfort or excessive redness around the wound areas, the patient may
need to be checked for infection by their doctor. Infections related to the Senza
®
Bluetooth
®
Trial System may
require the implanted components to be explanted.
6.14 Long-Term Effectiveness of Spinal Cord Stimulation
The long-term effectiveness of spinal cord stimulation has been documented. Not all patients realize long-term
benefits from spinal cord stimulation. Stimulation effectiveness at 10 kHz has been established for two years.
6.15 Mobile Phones and Other Bluetooth
®
-enabled Devices
Mobile phones and other Bluetooth
®
-enabled devices are not anticipated to interfere with the Senza
®
Bluetooth
®
Trial System. However, technology continues to change and interactions between the Senza
®
Bluetooth
®
Trial
System and mobile phones or other Bluetooth
®
-enabled devices are possible. Patients should contact their doctor
if they are concerned about mobile phones or other Bluetooth
®
-enabled devices interacting with their
neuromodulation system.
6.16 Limitations on Wireless Use
In some environments, such as aboard airplanes, in hospitals, near explosives, or in hazardous locations, the use
of wireless functions (e.g., Bluetooth
®
wireless technology) may be restricted. If patients are unsure of the policy
that applies to the use of their Senza
®
Bluetooth
®
Trial System in a particular environment, the patient should ask
for authorization before turning it on.
In environments where many Bluetooth
®
-enabled devices or other devices that use wireless radio are active
nearby, the Remote Control and Trial Stimulator may have problems connecting, and/or communicating with each
other. Due to signal interference, multiple attempts may be required. Refer to the Troubleshooting section of the
Senza
®
Bluetooth
®
Trial System Patient’s Manual (P/N: 10000890).
6.17 Maintenance
Apart from replaceable batteries for the Remote Control, the Senza
®
Bluetooth
®
Trial System does not contain any
user serviceable parts.
If any part of the Senza
®
Bluetooth
®
Trial System becomes damaged, loose, or does not function properly,
patients should discontinue therapy and contact their doctor. The system may require maintenance at the clinic or
may need to be replaced.
6.18 Device Disposal
Patients that want to dispose of any components in their system should return them to their doctor. Do not
dispose of the Trial Stimulator or Remote Control in fire as the batteries in these devices may explode. Do not