Impulse Dymanics OPTIMIZER Smart System User Manual

Part No.: 12-240-003-01-US Rev. 0
OPTIMIZER
®
Smart System
Physician’s Manual
For 2-Lead OPTIMIZER Smart System
Study (FIX-HF-5C2)
Limited by United States (Federal) law to investigational use
Federal law restricts this device to sale by or on the order of a physician

Impulse Dymanics OPTIMIZER Smart System Specifications

General

Brand	Impulse Dymanics
Model	OPTIMIZER Smart System
Category	Medical Equipment
Language	English

Summary

The OPTIMIZER SMART SYSTEM: AN OVERVIEW

Description of the OPTIMIZER Smart IPG

Provides a detailed overview of the OPTIMIZER Smart Implantable Pulse Generator (IPG) and its functions.

CONTRAINDICATIONS AND PRECAUTIONS

WARNINGS

Potential Complications of Device Implantation

Discusses risks associated with IPG implantation, including arrhythmias and lead-related issues.

CAUTIONS

Electrocautery

Explains potential interference and risks associated with using electrocautery devices.

Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI)

Details risks of MRI/NMR exposure, including device inhibition, heating, and potential damage.

POTENTIAL ADVERSE EFFECTS

DEVICE IMPLANTATION

General Considerations

Provides general guidance and warnings for the implantation procedure.

Connecting the Implanted Leads to the OPTIMIZER Smart IPG

OMNI SMART PROGRAMMER SYSTEM

Programmer Functions

Operating the OMNI Smart Programmer

INTERROGATION

Interrogating the OPTIMIZER Smart IPG

PROGRAMMING

Programming the OPTIMIZER Smart IPG

Details the process of programming modified parameter values into the OPTIMIZER Smart IPG.

EMERGENCY PROGRAMMING

Emergency Programming When the Programmer is OFF

Explains how to perform emergency programming when the programmer is turned off.

RESETTING THE OPTIMIZER SMART IPG

OPTIMIZER MINI CHARGER

Charger Operation