Boston Scientific SC-1216, Directions For Use Manual

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Instructions for Use
Implantable Pulse Generator
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Instructions for Use
SCS Implant Conditions for Full Body MRI Eligibility
CAUTION: To allow a patient full-body MRI scan eligibility under specific conditions, implant a Boston
Scientific SCS System with ImageReady MRI Technology described below. If the implant criteria
are not met, the patient will not have an SCS system with full-body MRI scan eligibility. MRI scans
performed under different conditions can result in patient injury or damage to the implantable device.
• Use only ImageReady MRI SCS system components (e.g., Leads and IPGs) as specified in the
ImageReady™ MRI Full Body Guidelines for the appropriate Boston Scientific SCS System
Note: Lead Extensions, Adapters, and Splitters are not full-body MRI scan eligible.
• Implant the IPG in the upper buttocks or lower flank.
• Implant the Lead in the epidural space.
• If using the Avista MRI Lead(s), use only the suture sleeves provided with the Avista™ MRI Lead
kit or the Clik™ X MRI Anchor to secure the Avista MRI Leads.
• Explant any previously abandoned Leads, Extensions, Splitters or Adapters that may be in the
patient (i.e. Leads, Extensions, Splitters, or Adapaters, or portions of, that are not connected
directly to an IPG).
Note: Other implanted medical devices may limit or restrict MRI scans.
• It is recommended that you enter all component model number and implant location information
using the ImageReady MRI Full Body Patient Eligibility Checklist and maintain it in the patient’s
medical records. When adding, changing, or removing IPGs, Leads or accessories, it is
recommended that you complete a new ImageReady MRI Full Body Patient Eligibility Checklist and
maintain it in the patient medical record.
• For the full body MRI conditions and MRI-specific warnings and precautions for conducting an MRI
scan, refer to the ImageReady MRI Full Body Guidelines for the appropriate Boston Scientific SCS
System
IPG Handling and Storage
• Handle the IPG and all components with care.
• Keep sharp instruments away from the components.
• Do not use the IPG if it has been dropped on a hard surface.
• Do not incinerate an IPG. Improper disposal of the device could result in an explosion. Devices
should be explanted in the case of cremation, and returned to Boston Scientific Neuromodulation
Corporation. An explant kit is available.
• Store the IPG between 0 °C and 45 °C ( 32 °F and 113 °F). Devices should always be kept in
temperature regulated areas within the acceptable temperature range. IPG damage can occur at
temperatures outside of this range.