Instructions For The Physician; Essential Performance; Telemetry Information - Boston Scientific Precision Montage MRI Informacion Para Medicos

Information for Prescribers

Instructions for the Physician

Implanted Stimulation Devices. If such implanted devices are indicated for the patient,
careful screening is required to determine if safe results can be achieved before permanently
implementing concurrent electrical therapies.
Postural Changes. Depending on the activity level of the patient, postural changes may affect
stimulation intensity. Instruct patients to keep the Remote Control on hand at all times, and
ensure that they understand how to adjust stimulation levels. Refer to Postural Changes in the
Instructions for Patients section of this manual, page 2, for additional information.
Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery,
external defibrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound, X-ray or
CT scan:
• Turn off stimulation at least five minutes before the procedure or application.
• All equipment, including ground plates and paddles, must be used as far away from the IPG
as possible.
• Every effort should be taken to keep fields, 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 confirm 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: 0.05 mW (-13 dBm) maximum
Magnetic Field Strength (at 3 m distance): 46 μA/m
Precision Montage™ MRI System Information for Prescribers
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