Instructions For Use; Lead And Lead Extension Handling And Storage; Paddle Lead Placement In The Epidural Space - Boston Scientific SC-3138- Série Mode D'emploi

Instructions for Use

Physician training is required. Boston Scientific also recommends that implanting physicians read all
product labeling prior to using our devices.

Lead and Lead Extension Handling and Storage

• Avoid damaging the Lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the Lead or Extension.
• Do not tie suture(s) directly to the Lead or Extension; use the provided Suture Sleeves.
• Avoid pulling an implanted Lead taut; provide a stress relief loop at the insertion site to minimize
tension on the Lead.
• Avoid handling the Lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments such as hemostats or scalpels to prevent damaging the
Lead.
• Wipe off any body fluids from the Lead connector end before connecting it to any other component.
Fluid contamination of these connections could compromise the integrity of the stimulation circuit.
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.

Paddle Lead Placement in the Epidural Space

1. Determine the appropriate vertebral level for Lead placement using fluoroscopic guidance.
2. Position, prep and drape the patient in the usual accepted manner.
3. Ensure adequate space prior to introducing the Paddle Lead.
OPTIONAL: A Passing Elevator or Paddle Blank may be used prior to introducing the 2x8 Paddle Lead
or 4x8 Paddle Lead into the epidural space (respectively). Select the appropriately sized Paddle Blank
for use with the 4x8 Paddle. Passing elevators and Paddle Blanks are designed to help verify that the
epidural space is cleared for placement of the Paddle Lead.
Grasp the curved area of the Passing Elevator with your fingertips. Grasp the tails of the Paddle
Blank with your fingertips as you would hold the Paddle Lead. While avoiding pressure on
the thecal sac and spinal cord, carefully and gently introduce the Passing Elevator or Paddle
Blank at a shallow angle into the epidural space along the midline. When the Passing Elevator
or Paddle Blank reaches the target site for the Lead, gently remove the elevator or blank.
CAUTION: Do not use the Passing Elevator or Paddle Blank to clear scar tissue or open up a narrow
spinal canal. Exerting excessive force may cause patient injury or breakage of the Passing Elevator.
4. Use the standard technique to introduce the Paddle Lead into the epidural space, visually ensuring that
the Contacts are facing down towards the dura.
Surgical Leads Directions for Use
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