Mr Conditions Of Use; Scs Implant System Conditions - Boston Scientific Spectra WaveWriter Mode D'emploi

MR Conditions of Use

The following Conditions of Use must be met in order for a patient with a Spectra WaveWriter SCS System
with ImageReady MRI Technology to undergo an MRI head scan. Adherence to the Conditions of Use must
be verified prior to each scan to ensure that the most up-to-date information has been used to assess the
patient's eligibility and readiness for an MRI head scan.

SCS Implant System Conditions

Appendix A, "Spectra WaveWriter SCS System ImageReady MRI Head Only Patient Eligibility," contains a
form that may be used by the physician managing the patient's SCS system to confirm the patient meets
the SCS Implant System Conditions for MRI Head Scans as described in this manual.
1. The patient is implanted with a Spectra WaveWriter SCS System comprised only of components
listed in "Table 1. Components that are eligible for Spectra WaveWriter SCS System with
ImageReady MRI Technology" on page 2 of this manual.
2. The patient is implanted with Lead lengths of 50 cm or shorter, as listed in Table 1.
Note: Leads should be connected directly into the IPG. Patient should not be implanted with
Lead extensions, splitters, or adapters.
3. The Lead implant location is epidural.
4. The patient has no abandoned Leads or IPGs
functioning Spectra WaveWriter SCS System).
5. No component of the Spectra WaveWriter SCS System (such as the implanted Leads, IPG, etc)
comes within 10 cm of the head coil. One way to verify this is:
a. The Lead distal tip placement is at or below the T5 thoracic spinal level. Only distal Lead tip
placement between T12 and T5 is allowed.
b. The IPG is implanted in the upper buttock or the lower flank.
6. No evidence of fractured Leads or compromised IPG-Lead system integrity
ImageReady MRI Guidelines for Spectra WaveWriter Spinal Cord Stimulator System
(such as Leads or IPGs that are not connected to the
MR Conditions of Use
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