Mr Conditions Of Use; Scs Implant System Conditions - Boston Scientific WaveWriter Alpha Manual Del Usuario

MR Conditions of Use

The WaveWriter Alpha System with ImageReady MRI Full Body Technology is MR Conditional. A patient
with this system may be scanned only under very specific conditions. Scanning under different conditions
may result in severe patient injury or device malfunction. The following Conditions of Use must be met in
order for a patient with a WaveWriter Alpha System with ImageReady MRI Full Body Technology to undergo
an MRI 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 scan.

SCS Implant System Conditions

Appendix A, "ImageReady MRI Full Body 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 Scans as described in this manual.
1. The patient is implanted with a WaveWriter Alpha SCS System composed only of components
listed in "Table 1. Components that are eligible for WaveWriter Alpha System with ImageReady
MRI Full Body Technology" on page 3 of this manual.
Note: Full body MRI Leads should be connected directly into the IPG. Patients should not be implanted with Lead
Extensions, Splitters, or Adapters.
2. The Lead implant location is epidural.
3. The patient has no abandoned Leads or IPGs
functioning WaveWriter Alpha System).
4. The IPG is implanted in the upper buttock or the lower flank.
5. No evidence of fractured Leads or compromised IPG-Lead system integrity.
6. The patient has been informed of what to do or expect in preparation for their MRI scan:
a. If the patient has a rechargeable IPG: Prior to arrival at the MRI Center, the patient should
ensure that the IPG is fully charged (IPG charge shown as three (3) bars on the Remote
Control) for the MRI scan. The patient should bring the Charger (in case charging is
necessary) to the MRI center. The Charger is MR Unsafe and must not be brought into the
MRI Scanner Room.
b. At the MRI Center, prior to entering the scanner room, the patient should enable MRI mode
using the Remote Control. The Remote Control is MR Unsafe and must not be brought into
the MRI Scanner Room.
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
(i.e. Leads or IPGs that are not connected to the
MR Conditions of Use
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