Use Instructions

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Table of Contents
About this document ............................................................................... 1
1 System Description ................................................................................. 3
Implantable Pulse Generator (IPG) .............................................................. 5
Carotid Sinus Lead (CSL) kit ...................................................................... 5
Programmer System (PGM) ........................................................................ 5
Optional Accessories for Use with the System ................................................. 6
2 Symbols and Definitions ........................................................................... 7
3 Indications and Contra-indications ............................................................. 9
Indications: ......................................................................................... 10
Contraindications: ................................................................................. 10
4 Warnings and Precautions ....................................................................... 11
General .............................................................................................. 12
IPG ................................................................................................... 14
CSL ................................................................................................... 16
Programmer ........................................................................................ 17
Implant Adapter, Implant Tool .................................................................. 17
5 Adverse Events .................................................................................... 19
6 Clinical Summary ................................................................................. 22
7 Physician and Training Experience ............................................................ 37
Training Requirements ........................................................................... 38
8 Emergency Personnel Information ............................................................. 39
Radiopaque Identifier ............................................................................. 40
ECG Artifact ........................................................................................ 40
Temporarily Inhibiting the IPG Output ......................................................... 40
9 Warranty & Disclaimer of Warranty .......................................................... 41
10 Specifications ..................................................................................... 43
Implantable Pulse Generator .................................................................... 44
Lead (Models 1036 and 1037) .................................................................... 46
Carotid Sinus Lead Repair Kit .................................................................... 47
Programmer System ............................................................................... 48
11 Regulatory Notices ............................................................................... 52
12 Electromagnetic Compatibility Declarations ................................................. 54
Programmer System EMC Precautions .......................................................... 55
Programmer System RF Specifications ......................................................... 61