Boston Scientific SC-2016 Series, Инструкция по применению

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Percutaneous Leads Directions for Use
Percutaneous Leads Directions for Use
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Registering the Leads
In accordance with international practice and regulatory legislation in some countries, a registration form is packed with each Boston Scientific Lead/
Lead extension/Splitter.
The purpose of this form is to maintain traceability of all products and to secure warranty rights. It also allows the institution involved in the evaluation
or replacement of a specific implanted Lead, accessory or device to gain quick access to pertinent data from the manufacturer.
Fill out the registration form included in the package contents. Return one copy to Boston Scientific, keep one copy for patient records, provide one
copy to the patient, and one copy to the physician.
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department
Instructions for Use
Physician training is required. Boston Scientific also recommends that implanting physicians read all product labeling prior to using our devices.
Lead, Lead Extension, and Splitter Handling and Storage
• Avoid damaging the Lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the Lead, extension, or Splitter.
• Do not tie suture(s) directly to the Lead, extension, or Splitter body; use the provided suture sleeves.
• For the Percutaneous Leads avoid forcing the Lead into the epidural or subcutaneous space by carefully clearing a path using the
Lead blank.
• 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.
• Wipe off any body fluids from the Lead stylet before inserting or reinserting it into the Lead.
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.
Infinion CX Lead
The Infinion CX Lead has two tails to enable insertion into 8-contact IPG ports without the use of a Splitter 2x8. The two tails will not fit through a
standard 14 gauge insertion needle or Epimed needle, therefore these needles are not compatible with the Infinion CX Lead. Do not use a standard
14 gauge introducer or Epimed needle to introduce the Infinion CX Lead.
Use only the Entrada Needle with peelable sheath to introduce the Infinion CX Lead into the epidural or subcutaneous space.
An Anchor must be pre-loaded on the distal end of the Infinion CX Lead prior to inserting the Lead into the Entrada Needle. When using an Anchor
or suture sleeve with the Infinion CX Lead, the stylet may be in place within the Lead when the Anchor is loaded on the Lead. Ensure that stylet is
removed from the Lead prior to securing the Anchor.
Entrada™ Needle
The Entrada Needle with peelable sheath is required to insert the Infinion CX Lead into the epidural or subcutaneous space. The Entrada Needle
may also be used with all percutaneous Leads listed under “Product Model Numbers” on page ii.
Fully Assembled Entrada Needle
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