Precautions - Boston Scientific WaveWriter Alpha Informacion Para Medicos

Information for Prescribers
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in
stimulation, or interfere with Remote Control communication. If an electromagnetic field is strong enough to turn stimulation off, this will be temporary
and stimulation will automatically return once the electromagnetic field is removed. Patients should be advised to avoid or exercise care around the
following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments: Patients
should proceed with caution, ensuring that they move through the center of the detector as quickly as possible. Interference from these devices
should not cause permanent damage to the implanted device.
• Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand-held scanners: Patients should
request assistance to bypass the security screener and advise the security staff that they have an implanted medical device. If patients must pass
through the security screener, they should move through the security screener quickly and stay as far as allowed from the screener.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can broadcast a radio frequency (RF) signal. The
high energy fields produced by these systems may interfere with the operation of the Remote Control and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as Wi-Fi routers, Cordless Phones, Bluetooth® Wireless streaming devices, Baby Monitors,
Microwave Ovens.
Note: When in close proximity, equipment that generate strong electromagnetic fields might cause uncomfortable or jolting stimulation or interfere
with wireless communication even if they comply with CISPR requirements.

Precautions

Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the
Stimulator, particularly if used in close proximity to the device:
• lithotripsy
• electrocautery (See "Instructions for the Physician" on page 3)
• external defibrillation
• radiation therapy (Any damage to the device by radiation may not be immediately detectable.)
• ultrasonic scanning
• high-output ultrasound
X-ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT Scans are unlikely to damage the Stimulator if stimulation is turned
off.
If any of the above is required by medical necessity, refer to "Instructions for the Physician" on page 3. Ultimately, however, the device may
require explantation as a result of damage to the device.
Automobiles and Other Equipment. Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/
equipment with therapeutic stimulation switched on. Stimulation must be turned off first. Sudden stimulation changes, if they occur, may distract
patients from attentive operation of the vehicle or equipment. If using therapy that does not produce a sensation, postural changes are less likely to
affect the patient.
Post Operative. During the two weeks following surgery, it is important that patients use extreme care so that appropriate healing will secure the
implanted components and close the surgical incisions:
• Patients should not lift objects of more than five pounds.
• Patients should not engage in rigorous physical activity such as twisting, bending, or climbing.
• If new Leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients should be instructed that if discomfort continues
beyond two weeks, they should contact their healthcare provider.
If patients notice excessive redness around the wound areas during this time, they should contact their healthcare provider to check for infection and
administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their healthcare provider before making lifestyle changes due to decreases in pain.
Stimulator Orientation. Patients should never attempt to change the orientation of the Stimulator or turn over the Stimulator. Patients should avoid
touching the incisions or Stimulator site. If the Stimulator flips over in the Patient's body, it may be unable to communicate with the Remote Control
or Clinician Programmer. If the rechargeable Stimulator flips over in the Patient's body, it cannot be charged. If the Patient knows that the device has
turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her physician to arrange an evaluation of the system. In
some cases, the skin over the Stimulator may become very thin over time. If this occurs, Patients should contact their healthcare provider.
Lead Location. In some instances a Lead can move from its original location, and stimulation at the intended pain site can be lost. If this occurs,
Patients should consult their healthcare provider who may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the Lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of battery functionality, or Lead breakage. If the device stops
working even after complete charging (up to four hours), Patients should turn off the Stimulator and contact their healthcare provider so that the
system can be evaluated.
Operating Temperature. The operating temperature of the ETS and Remote Control is 5 to 40 °C (41 to 104 °F). For proper operation, do not use
the Charger if the ambient temperature is above 35 °C (95 °F).
Non-rechargeable IPGs will enter storage mode if its temperature falls below 8 °C. When the IPG is in storage mode, it will not connect to a Remote
Control or Clinician Programmer. To exit storage mode, increase the IPG temperature above 8 °C.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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