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– Pulsante® SPG Microstimulator System Implant Manual
CONTENTS
1. Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4. Implant Identification Card . . . . . . . . . . . . . . . . . . 3
5. System Overview . . . . . . . . . . . . . . . . . . . . . . . . . 3
6. Implant Procedure Overview . . . . . . . . . . . . . . . . 6
7. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 7
8. Warnings & Precautions . . . . . . . . . . . . . . . . . . . 7
9. Risks & Side Effects . . . . . . . . . . . . . . . . . . . . . . 11
10. Storage & Handling . . . . . . . . . . . . . . . . . . . . . . .12
11. How to Implant the Microstimulator
. . . . . . . .
13
12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
13. Technical Specifications . . . . . . . . . . . . . . . . . . . 20
14. Information and Support . . . . . . . . . . . . . . . . . . . 23
1. WELCOME
Welcome to the Pulsante® family! The instructions in this Manual are intended for physician
implanters of the Pulsante® SPG Microstimulator. Please familiarize yourself with the Implant
Manual, Programming Manual, and Patient Manual prior to using the Pulsante® SPG Microstimulator
System.
2. INTENDED USE OF THE PULSANTE® SPG MICROSTIMULATOR SYSTEM
In the United States, the Pulsante® SPG Microstimulator System is intended to relieve the acute pain
of cluster headache.
3. SYMBOLS
Symbols and definitions used for the Pulsante® SPG Microstimulator System:
For Prescription Use Only
Consult Operating Instructions
Model Number
Serial Number
Lot Number
Content
Use Only With
Peel Apart
Warning/Precaution
Storage and Transport Temperature Range
Keep Dry
Manufactured By
