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Introducer Kit
Model SC-4365
Caution: Federal Law restricts this device to
sale, distribution, and use by or on the order
of a physician.
Description
The Boston Scientific model SC-4365
Introducer Kit is intended to be used to
prepare or preserve a path for a lead with
a recommended outer diameter of up to
1.4 mm. This accessory kit contains two
Introducer sheaths of different lengths.
Indications
The Boston Scientific model SC-4365
Introducer Kit is intended for the
percutaneous introduction and placement of
Spinal Cord Stimulation (SCS) leads.
Contraindications
Refer to the appropriate lead implant manual
for a complete list of contraindications for
SCS lead use.
Sterilization and Handling
• This product has been sterilized with
ethylene oxide (EtO).
• This product is intended for single use
only. DO NOT reuse this product.
WARNINGS
• Carefully examine all product packaging
before use. If the product packaging is
damaged, the sterile seal is broken, or the
"Use by" date is past, DO NOT use the
package contents.
• Do not cut the Introducer. Cutting the
Introducer could cause sharp edges
which may result in tissue damage.
• For a complete list of warnings
associated with lead implantation, see the
appropriate lead implant manual.
Directions for Use
For detailed lead implant instructions, refer to
the appropriate lead implant manual.
CAUTION:
Do not use excessive force when
advancing the Introducer. Using excessive
force may result in damage to the
Introducer.
Replacement of Insertion Needle
1. Verify that the Introducer is the
appropriate size and length for the lead
being implanted.
2. After inserting the epidural needle into
the epidural space, introduce the lead
through the insertion needle. For detailed
instructions, refer to the appropriate lead
implant manual.
3. Using fluoroscopic guidance, advance
the lead into the epidural space until the
last contact is at least ½ vertebral body
beyond the tip of the needle.
9055879-006
WARNINGS
Introducer Kit
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