Intended Use; Package Contents - Boston Scientific Precision M8 Instrucciones De Uso

Intended Use

The Precision™ M8 Adapter is a 1 x 8 in-line
connector that is designed to connect specific
Medtronic® leads to the Boston Scientific SCS
implantable pulse generators, OR Cables, leads,
and lead extensions, as part of a spinal cord
stimulation procedure.
Lead Compatibility
The Boston Scientific Precision M8 Adapter is
compatible with the following Medtronic leads and
lead extensions:
• Specify™ 2x8 Model 39286
• Specify 5-6-5 Model 39565
• 1x8 Compact Model 3778, 3878
• 1x8 Standard Model 3777, 3877
• 1x8 Sub-Compact Model 3776, 3876
• Test: 1x8 Compact Model 3874
• Test: 1x8 Standard Model 3873
• Test: 1x8 Sub-Compact Model 3875
• Model 37081 Extension
• Model 37083 Extension
• Model 37082 Extension
• Vectris™ SureScan® MRI 1x8 Subcompact
Model 977A160, 977A175, 977A190
• Vectris SureScan MRI 1x8 Compact Model
977A260, 977A275, 977A290
• Vectris SureScan MRI Trial Leads Model
977D160, 977D260
WARNING: The Vectris Lead has not been tested
for compatibility with an MRI environment when
used with the Boston Scientific SCS Systems via
the Precision M8 adapter. MRI scanning under
conditions different than those in the labeling can
result in severe patient injury.

Package Contents

• (1) Precision M8 Adapter
• (1) Torque wrench
• (1) Clinician eDFU card or DFU
• (1 set) Product identification stickers
• (1) Device registration form
Med A is sold separately.
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 M8 Adapter to
prevent damage to the septum seal plug.
Precision™ M8 Adapter Directions for Use
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