Use Instructions

Relative humidity has no impact on the OPTIMIZER Smart Mini IPG.

2.0 USER PROFILE AND TRAINING

The operators of the OPTIMIZER Smart Mini System include patients, physicians (and the trained

medical personnel who assist them), and Impulse Dynamics representatives. Physicians, medical

personnel, and Company representatives who operate the OPTIMIZER Smart Mini System should be

familiar with the operation of electronic medical equipment, in particular the operation of implanted

medical devices and programmers.

Physicians and medical personnel can participate in a Company-sponsored training program that will

provide both theoretical and hands-on training regarding the technology, device features, and detailed

operating instructions for the OPTIMIZER Smart Mini IPG, the Intelio Programmer, and the Vesta

Charger. The need for future retraining regarding the OPTIMIZER Smart Mini System is determined by

Company personnel based on the user’s individual implant history and frequency.

Patient training will be limited to the use of the Vesta Charger and will be provided by Impulse Dynamics

Representatives post-implant.

3.0 INDICATIONS OF USE

The OPTIMIZER Smart System, which delivers CCM therapy, is indicated to improve 6 minute hall walk,

quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic

despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT,

and have a left ventricular ejection fraction ranging from 25% to 45%.

The OPTIMIZER Smart Mini system delivers non-excitatory CCM signals to the heart and has no

pacemaker or ICD functions.

4.0 CONTRAINDICATIONS AND PRECAUTIONS

Use of the OPTIMIZER Smart Mini system is contraindicated in:

1. Patients with a mechanical tricuspid valve

2. Patients in whom vascular access for implantation of the leads cannot be obtained

5.0 WARNINGS

5.1 Potential Complications of Device Implantation

Just like any surgical procedure, implantation of an OPTIMIZER Smart Mini IPG is associated

with certain risks. Complications of IPG implantation reported in the literature include, but are not

limited to:

• Arrhythmias induced by the IPG, including life-threatening arrhythmias (e.g., ventricular

fibrillation)

• Infection

• Skin necrosis

• Device migration

• Hematoma formation

• Seroma formation

• Histotoxic reactions (also see: Potential Adverse Effects, Section 7)

Programming high sensitivities (i.e. sensitivity settings less than 2 mV) may increase the system’s

susceptibility to electromagnetic interference, which could either inhibit or trigger CCM therapy

delivery.

Acute and chronic complications reported in the literature include, but are not limited to: