Boston Scientific Precision - Essential Performance; Telemetry Information

Safety Information
Clinician Manual
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Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery, external
debrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound:
• Turn off stimulation at least ve minutes before the procedure or application.
• All equipment, including ground plates and paddles, must be used as far away from the IPG as
possible.
• Bipolar electrocautery is recommended. Do not use monopolar electrocautery.
• Every effort should be taken to keep elds, including current, radiation, or high-output ultrasonic
beams, away from the IPG.
• Equipment should be set to the lowest energy setting clinically indicated.
• Instruct patients to conrm IPG functionality following treatment by turning on the IPG and gradually
increasing stimulation to the desired level.
Essential Performance
Failure of the external electrical components will not result in an unacceptable risk to the user.
Telemetry Information
Frequency Band: 119 – 131 kHz
Modulation type: FSK
Effective Radiated Power: 0.4 mW (-4 dBm) maximum
Magnetic Field Strength (at 3 m distance): 94 μA/m