AIM HIGHer OPTIMIZER User manual

Part No.: 12-250-004-US Rev. 01
OPTIMIZER™Smart Mini
System
* * *
For the Treatment of Symptomatic Heart Failure
(With LV Ejection Fraction ≥ 40% and ≤ 60%)
Patient Manual for the
AIM HIGHer Clinical Trial
Limited by United States (Federal) law to investigational use

Impulse Dynamics (USA) Inc.
Suite 100
50 Lake Center Executive Parkway
401 Route 73 N Bldg. 50
Marlton, NJ 08053-3425
CCM™ is a trademark of Impulse Dynamics.
OPTIMIZER®is a US registered trademark property of Impulse Dynamics
The information in this document can be changed without prior notice.
No part of this manual may be reproduced or transmitted in any way or by
any means, either electronic or mechanical, for any purpose without the
prior express written consent of Impulse Dynamics.
The OPTIMIZER Smart Mini system and the CCM technology are
protected by several U.S. Patents. For an up-to-date list of relevant
patents and patent applications, visit our patents page:
http://www.impulse-dynamics.com/us/patents
Revision 01, Date of Issue: 2022-04-07

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TABLE OF CONTENTS
IMPORTANT MEDICAL NOTICE ........................................................................... i
1.0 INTRODUCTION.......................................................................................... 1
2.0 THE OPTIMIZER SMART MINI SYSTEM.................................................... 1
2.1 OPTIMIZER Smart Mini Implantable Pulse Generator ....................... 1
2.2 Vesta Charger ....................................................................................3
3.0 POTENTIAL COMPLICATIONS..................................................................3
3.1 Complications Associated with Implantation ......................................3
3.2 Complications Associated with Device / Charger Operation ..............5
4.0 FOLLOWING IMPLANTATION ................................................................... 6
5.0 LIVING WITH YOUR OPTIMIZER SMART MINI IPG .................................. 7
5.1 General Expectations ......................................................................... 7
5.2 Effect on Your Activities ..................................................................... 7
5.3 Medications ........................................................................................ 7
5.4 How Other Devices May Affect Your OPTIMIZER Smart Mini IPG ....7
5.5 The Importance of Your Implanted Medical Device Identification Card
........................................................................................................... 9
6.0 VESTA CHARGER .................................................................................... 10
6.1 System Components ........................................................................ 10
6.2 Features ........................................................................................... 11
6.3 Description ....................................................................................... 12
6.4 Charging Method.............................................................................. 12
6.5 Removal and Installation of the Plug Adapter .................................. 13
6.5.1 Removal of the Plug Adapter ................................................. 13
6.5.2 Installation of the Plug Adapter .............................................. 14
6.6 Charging Your Vesta Charger .......................................................... 15
6.7 Charging Your OPTIMIZER Smart Mini IPG .................................... 18
6.8 Termination of the Charging Session ............................................... 22
6.8.1 Early Termination of Charging Session .................................. 22
6.8.2 Termination of Charging Session Due to IPG Temperature ... 23

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6.8.3 Termination of Charging Session Due to Charging IPG Timeout
24
6.8.4 Termination of Charging Session Due to Low Charger Battery
Level.......................................................................................24
6.9 Vesta Charger Placement When Not Being Used for Device Charging
.........................................................................................................25
6.10 Frequency of Charging Sessions .....................................................25
6.11 Communications with Your OPTIMIZER Smart Mini IPG .................26
6.12 Call Doctor Alert Codes ....................................................................28
6.13 Cleaning ...........................................................................................30
6.14 Maintenance.....................................................................................30
6.15 Storage and Handling.......................................................................31
6.16 Disposal............................................................................................31
7.0 REPLACEMENT OF YOUR OPTIMIZER SMART MINI IPG.....................32
8.0 FREQUENTLY ASKED QUESTIONS........................................................32
APPENDIX I .........................................................................................................34
Statement of FCC Compliance...................................................................34
FCC Compliance of the OPTIMIZER Smart Mini IPG ......................34
FCC Compliance of the Vesta Charger ............................................35
Electromagnetic Immunity ..........................................................................36
Electromagnetic Immunity of the OPTIMIZER Smart Mini IPG.........36
Electromagnetic Immunity of the Vesta Charger ..............................41
Electromagnetic Emissions ........................................................................44
Electromagnetic Emissions from the OPTIMIZER Smart Mini IPG...44
Electromagnetic Emissions from the Vesta Charger ........................ 47
APPENDIX II ........................................................................................................52
Wireless Technology ..................................................................................52
Quality of Service (QoS) for Communications between the Vesta
Charger and the OPTIMIZER Smart Mini IPG........................54
Troubleshooting Wireless Connection between OPTIMIZER Smart
Mini IPG and Vesta Charger................................................... 56

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IMPORTANT MEDICAL NOTICE
24-hour Support Hotline: [phone]
You are participating in a blinded clinical research study. If you go to
the emergency room, please contact the study doctor or the 24-hour
Support Hotline IMMEDIATELY.
It is important that you carry your Implanted Medical Device Identification
Card and a current list of your medications with you at all times. In the
event of a medical emergency, the Implanted Medical Device Identification
Card contains information of great importance to an attending physician
and will assist in expediting any emergency medical care you may require.
In addition, it is important to notify all your health care providers that you
have an OPTIMIZER Smart Mini device implanted. As such, the next time
you visit your doctor or dentist, show them your Implanted Medical Device
Identification Card (see example below) so that a copy of it may be made
for their records. If you have a smart phone with a camera, it may be
helpful to take a picture of both the front and back of your Implanted
Medical Device Identification Card in case you ever misplace it or forget to
bring it with you.
Implanted Medical Device Identification Card (front)

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Implanted Medical Device Identification Card (back)

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1.0 INTRODUCTION
You are participating in an investigation called the AIM HIGHer Clinical
Trial and have received the implantable OPTIMIZER Smart Mini System.
The AIM HIGHer Clinical Trial is a randomized study to evaluate the
effectiveness of the Cardiac Contractility Modulation (CCM) therapy in
symptomatic heart failure patients with a Left Ventricular Ejection Fraction
(LVEF) of ≥ 40% and ≤ 60%. This is a blinded study and you have been
randomly placed into one of two patient groups for the first 18 months of
the study. You have 67% chance of being placed in the CCM Therapy ON
group and a 33% chance of being placed in the CCM Therapy OFF group.
Neither you nor your doctor will know in which group you have been
placed.
The purpose of this manual is to provide you with information about the
OPTIMIZER Smart Mini system, what to expect after your implant
procedure, introduce you to the components of the system, and provide
you with instructions on how to use the Vesta Charger.
2.0 THE OPTIMIZER SMART MINI SYSTEM
The OPTIMIZER Smart Mini system is comprised of the following
components:
•OPTIMIZER Smart Mini Implantable Pulse Generator (IPG)
•Vesta Charger
2.1 OPTIMIZER Smart Mini Implantable Pulse
Generator
The OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) is
a medical device used for the treatment of NYHA Class III heart
failure. It is typically implanted under the skin in the upper left or
right chest.
Connected to the OPTIMIZER Smart Mini IPG are two (or
optionally three) cardiac leads that your doctor will insert through
a large vein and into the heart during the implantation process.
These leads have electrodes that allow the OPTIMIZER Smart
Mini IPG to monitor the electrical activity of your heart and deliver
special Cardiac Contractility Modulation (CCM) therapy pulses to
the heart at a specific time during each heartbeat.

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The primary effect of this CCM therapy is an increase in the
efficiency and strength of each cardiac contraction, with the
intended result being that more blood is pumped out by the heart
with every heartbeat.
The OPTIMIZER Smart Mini IPG is powered by a rechargeable
battery to extend its service life. A charger specifically designed to
recharge the battery of the OPTIMIZER Smart Mini IPG will be
provided to you after your implant surgery.
The expected life of the OPTIMIZER Smart Mini IPG is limited by
the expected service life of its rechargeable battery.
With weekly charging of your OPTIMIZER Smart Mini IPG, the
rechargeable battery inside the OPTIMIZER Smart Mini IPG
should provide you with at least 20 years of service.
Your OPTIMIZER Smart Mini IPG will need to be replaced when
its battery, after being fully recharged, can no longer maintain
enough charge to deliver CCM therapy for an entire week without
becoming severely depleted.
When being evaluated for elective replacement, you will be
instructed to fully charge your OPTIMIZER Smart Mini IPG 7 days
before your scheduled routine checkup. During your checkup,
your doctor may evaluate the charge capacity of the battery in
your OPTIMIZER Smart Mini IPG.
Figure 1: OPTIMIZER Smart Mini IPG

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2.2 Vesta Charger
The Vesta Charger is powered by a rechargeable battery and is
specifically designed for use with the OPTIMIZER Smart Mini IPG.
After your implant procedure, you will be provided with a Vesta
Charger and receive instructions on its usage. Please proceed to
Section 6.0 for more details about your Vesta Charger.
Figure 2: Vesta Charger
3.0 POTENTIAL COMPLICATIONS
3.1 Complications Associated with Implantation
As with any surgical procedure, the implantation of the
OPTIMIZER Smart Mini IPG involves some degree of risk. This
section is intended to provide you with an explanation of the
various potential complications associated with having a device
implanted. These potential complications are not unique to the
OPTIMIZER Smart Mini IPG, as they may also occur during the
implantation of other implantable cardiac devices (e.g., cardiac
pacemakers or defibrillators).
The risks associated with the implantation are listed in Table 1
and are grouped based on their prevalence.

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Table 1: Risks Associated with Implantation
Common (greater than or equal to 5%)
•Post-procedural pain, bruising, and discomfort at insertion site
•Bleeding
•Infection at site of insertion
•Pocket hematoma
•Migration of leads
•Migration of implanted IPG
Uncommon (between 1-5%)
•Chest trauma (such as a collapsed lung or bleeding into the
chest)
•Generator complication
•Cardiac perforation (puncture of the heart caused by the
leads)
•Endocarditis (infection of the heart valves)
•Arrhythmia (irregular heartbeat, including heartbeats that are
too slow or too fast)
•Tricuspid valve damage (the valve between the right upper
and lower chambers of the heart that prevents blood from
flowing back into the upper chamber), possibly leading to
tricuspid valve regurgitation or leakage
•Vessel trauma (perforation, dissection, or rupture)
•Thrombosis (formation of blood clots in the veins)
•Damage to the specific type of heart tissue responsible for
triggering heartbeats (i.e., the cardiac conduction system)
•Allergic reaction
Rare (less than 1%)
•Bradycardia (slow heart rate)
•Cardiac tamponade (build up of fluid around the heart that can
be life-threatening)
•Myocardial infarction (heart attack)
•Mini stroke (TIA), or stroke
•Death