Table of Contents
INFORMATION FOR USE ......................................................................... 1
Device Description............................................................................. 1
Indications ......................................................................................... 1
Contraindications ............................................................................... 1
Warnings ........................................................................................... 1
ICD/Lead Compatibility.................................................................. 2
MRI Exposure................................................................................ 2
Diathermy Exposure...................................................................... 2
Implantation................................................................................... 2
Electrical Performance .................................................................. 2
Conversion Testing ....................................................................... 3
Securing and Tunneling ................................................................ 3
Post-Implant Evaluation ................................................................ 3
Single Use Only............................................................................. 3
Precautions........................................................................................ 3
Potential Adverse Events .............................................................. 4
Warranty ............................................................................................ 5
Symbols on Packaging ...................................................................... 6
DEVICE FEATURES.................................................................................. 7
Detailed Device Description............................................................... 7
LEAD EVALUATION ............................................................................... 10
Implant Information .......................................................................... 10
Included Items ................................................................................. 10
Opening Instructions........................................................................ 11
Sterilization ...................................................................................... 11
Surgical Preparation ........................................................................ 11
Accessories ..................................................................................... 11
Suture Sleeves ............................................................................ 11
Fixation Tool................................................................................ 12
Stylets.......................................................................................... 12
Stylet Guide................................................................................. 12
Transvalvular Insertion Tool ........................................................ 12
Vein Pick ..................................................................................... 13
Lead Caps ................................................................................... 14
Handling the Lead ........................................................................... 14
IMPLANTATION ...................................................................................... 15
Inserting the Stylet ........................................................................... 15
Handling the Fixation Helix .............................................................. 15
Inserting the Lead ............................................................................ 16
Positioning the Lead ........................................................................ 18
Lead Fixation ................................................................................... 19
358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM
