Intended Use; Package Contents; Directions For Use - Boston Scientific Precision S8 Serie Instrucciones De Uso

Intended Use

The Precision™ S8 Adapter is a 1 x 8 in-line
connector that is designed to connect specific St.
Jude (Abbott) leads to the Boston Scientific SCS
implantable pulse generators, OR Cables, and lead
extensions, as part of a spinal cord stimulation
procedure.
Lead Compatibility
The Boston Scientific Precision S8 Adapter is
compatible with the following St. Jude (Abbott)
leads and lead extensions:
• 3283/3286/3268/3269 Lamitrode S8
• 3280 Lamitrode 8
• 3244/3262/3263 Lamitrode 44
• 3245/3264/3265 Lamitrode 44C
• 3208 Lamitrode Tripole 8
• 3210 Lamitrode Tripole 8C
• 3288 Lamitrode 88
• 3289 Lamitrode 88C
• 3219 Lamitrode Tripole 16
• 3214 Lamitrode Tripole 16C
• 3228 Penta
• 3183/3186/3189/3191 Octrode
• 3086 Octrode Trial Lead Kit
• 2283 8-channel Adapter
• 3341 / 3342 / 3343 / 3346 Dual 4 Extension
• 3382 / 3383 / 3386 Single 8 Extension

Package Contents

• (1) Precision S8 Adapter
• (1) Torque wrench
• (1) Clinician eDFU card or DFU
• (1 set) Product identification stickers
• (1) Device registration form
Warning
• The Precision S8 Adapter has not been
tested for electromagnetic compatibility or for
safety in an MRI environment.
Cautions
• Inspect the condition of the sterile package
before opening the package and using the
contents. Do not use the contents if the
package is broken or torn, or if contamination
is suspected because of a defective sterile
package seal. Do not reuse, reprocess, or
resterilize.
• Do not use if the product is past the labeled
expiration date.
• Do not use if labeling is incomplete or
illegible.
• Do not bend, kink, or stretch the extension
or Adapter; this may break its wires or
connections. Broken wires or connections
may create an open circuit, resulting in
component failure, loss of stimulation, and
potential surgical intervention.
• Do not retract the setscrew completely as the
setscrew may fall out.
• Minimize the number of torque wrench
insertions into the Precision S8 Adapter to
prevent damage to the septum seal plug.

Directions for Use

1. Refer to the appropriate St. Jude (Abbott)
product labeling for instructions on opening
the midline incision and explanting St. Jude
(Abbott) lead extensions or IPG.
2. Carefully open the Precision S8 Adapter
package and transfer the contents of the inner
tray to the sterile field.
3. Ensure that the St. Jude (Abbott) lead is clean
and not damaged.
4. Retract the setscrews in all Adapters: Insert the
torque wrench into the septum containing the
setscrew and turn the torque wrench counter-
clockwise (Figure 1).
Precision S8 Adapter Directions for Use
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