St. Jude Medical Tendril MRI LPA1200M, Руководство пользователя

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How Supplied
The lead is packaged one lead per package in a sterile package. Each package contains:
 One lead
 One radiopaque suture sleeve attached to lead
 One spare suture sleeve
 One vein lifter
 Two clip-on tools
 One tip retainer (to be removed prior to implant)
 Stainless steel stylets with knob colors designating degree of firmness
 One literature packet.
Clinician Use Information
Physician Training
Physicians should be familiar with sterile implant procedure and follow-up evaluation.
The following sections describe various stages of lead implantation. Procedures included in these
sections are only recommendations. Actual implant procedures are left to the discretion of the
implanting physician.
Directions for Use
Preparation
Before implanting the lead:

confirm compatibility between the device and the lead and review the implantation
instructions

select an appropriate venous route

select and install an appropriate stylet

test the mechanical function of the helix

confirm the helix is completely retracted before implantation
The Fixation Tool
Selected St. Jude Medical
™
stylet kits
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include a simple fixation tool designed to insert and secure
the stylet in the lead and to allow extension and retraction of the helix.
The tool is made up of two linked pieces. The proximal (white) portion contains a thumbscrew
which holds the stylet in place. The distal (gray) portion contains a thumbscrew which secures the
fixation tool to the lead's marker ring. While holding the fixation tool in one hand, use the other
hand to unscrew/screw the fixation tool to the connector pin.
Removing and Inserting the Stylet
To remove a stylet from the fixation tool, unscrew the proximal thumbscrew on the tool by turning
it counter-clockwise and withdraw the stylet.
6 For additional information, contact your St. Jude Medical Sales Representative.