Description; Scs Systems With Imageready™ Mri Technology; Package Contents; Lead Storage - Boston Scientific Avista MRI Mode D'emploi

Description

Leads function as a component of Spinal Cord Stimulator (SCS) systems by delivering electrical
stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain
sensation. The eight-contact Avista™ MRI percutaneous lead is available in lengths of 56 cm and 74 cm.
Each lead has eight electrode contacts located near the distal end. Each contact is 3 mm in length and is
spaced 1 mm from the adjacent contact.
The Avista™ MRI Lead is designed using Boston Scientific's Heat-Canceling Technology: The triple layers
of the lead are engineered to work together to cancel the RF energy that causes heat under the labeled
MRI conditions for use.
SCS Systems with ImageReady™ MRI Technology
When an appropriate Boston Scientific SCS System with ImageReady MRI Technology is implanted as
directed (see "SCS Implant Conditions For Full-body MRI Eligibility" in this manual), a patient's full body
may be eligible for MRI scans under specific conditions.
For detailed information about eligibility and conditions for MRI scanning, refer to the ImageReady MRI
Full Body Guidelines for your SCS System.

Package Contents

(1) Percutaneous Lead with pre-loaded Curved Stylet
(1) Stylet Ring with a Straight Stylet
(2) Suture Sleeves
(1) Insertion Needle with Stylet
(1) Steering Cap
(1) Lead Position Labels—left and right (non-sterile)
(1) Device Registration Form/Temporary Patient Identification Card
(1) Product Literature

Lead Storage

Store components between 0 °C and 45 °C (32 °F and 113 °F) in an area where they are not exposed to
liquids or excessive moisture. Temperatures outside of the stated range can cause damage.

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 as 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 your 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.
Note: Retrograde lead placements have not been evaluated for MRI.
Description
Avista™ MRI xxcm Contact Lead Kit
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