Impulse Dynamics OPTIMIZER Integra CCM-D Manuale utente

Part No.: 12-250-005-US Rev. 00

OPTIMIZER®Integra CCM-D

System

* * *

Patient’s Manual

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 may change 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 Integra CCM-D 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 00, Date of Issue: 2022-11-30

TABLE OF CONTENTS

IMPORTANT MEDICAL NOTICE ........................................................................... i

1.0 INTRODUCTION.......................................................................................... 1

2.0 THE OPTIMIZER INTEGRA CCM-D SYSTEM............................................1

2.1 OPTIMIZER Integra CCM-D Implantable Pulse Generator ................1

2.2 Guardio Charger ................................................................................3

3.0INDICATIONS OF USE................................................................................ 4

4.0 POTENTIAL COMPLICATIONS..................................................................4

4.1 Complications Associated with Implantation ......................................4

4.2 Complications Associated with Device / Charger Operation ..............6

5.0 FOLLOWING IMPLANTATION ................................................................... 6

6.0 LIVING WITH YOUR OPTIMIZER INTEGRA CCM-D IPG .......................... 7

6.1 General Expectations ......................................................................... 7

6.2 Effect on Your Activities ..................................................................... 7

6.3 Medications ........................................................................................ 7

6.4 How Other Devices May Affect Your OPTIMIZER Integra CCM-D IPG

........................................................................................................... 8

6.5 The Importance of Your Implanted Medical Device Identification Card

......................................................................................................... 10

7.0 GUARDIO CHARGER ............................................................................... 11

7.1 System Components ........................................................................ 11

7.2 Features ........................................................................................... 12

7.3 Description ....................................................................................... 13

7.4 Charging Method.............................................................................. 13

7.5 Removal and Installation of the Plug Adapter .................................. 14

7.5.1 Removal of the Plug Adapter ................................................ 14

7.5.2 Installation of the Plug Adapter ............................................. 15

7.6 Charging Your Guardio Charger ...................................................... 16

7.7 Charging Your OPTIMIZER Integra CCM-D IPG ............................. 19

7.8 Termination of the Charging Session ............................................... 24

7.8.1 Early Termination of Charging Session................................. 24

7.8.2 Termination of Charging Session Due to IPG Temperature..25

7.8.3 Termination of Charging Session Due to Charging IPG

Timeout.................................................................................25

7.8.4 Termination of Charging Session Due to Low Charger Battery

Level .....................................................................................26

7.9 Guardio Charger Placement When Not Being Used for Device

Charging...........................................................................................26

7.10 Frequency of Charging Sessions .....................................................27

7.11 Communications with Your OPTIMIZER Integra CCM-D IPG ..........28

7.12 Call Doctor Alert Codes ....................................................................30

7.13 Cleaning ...........................................................................................32

7.14 Maintenance.....................................................................................32

7.15 Storage and Handling.......................................................................33

7.16 Disposal............................................................................................33

8.0 REPLACEMENT OF YOUR OPTIMIZER INTEGRA CCM-D IPG .............34

9.0 FREQUENTLY ASKED QUESTIONS........................................................34

APPENDIX I .........................................................................................................37

Electromagnetic Immunity ..........................................................................37

Electromagnetic Immunity of the OPTIMIZER Integra CCM-D IPG 37

Electromagnetic Immunity of the Guardio Charger .........................42

Electromagnetic Emissions ........................................................................46

Electromagnetic Emissions from the OPTIMIZER Integra CCM-D

IPG........................................................................................46

Electromagnetic Emissions from the Guardio Charger ................... 49

APPENDIX II ........................................................................................................56

Wireless Technology ..................................................................................56

Quality of Service (QoS) for Communications between the Guardio

Charger and the OPTIMIZER Integra CCM-D IPG ...............58

Troubleshooting Wireless Connection between OPTIMIZER Integra

CCM-D IPG and Guardio Charger ........................................60

IMPORTANT MEDICAL NOTICE

24-hour Support Hotline: 866-312-5370

You are participating in a clinical research study. If you go to the

emergency room, please contact the study doctor or call 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 Integra CCM-D 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)

Implanted Medical Device Identification Card (back)

1.0 INTRODUCTION

Congratulations on receiving your OPTIMIZER Integra CCM-D System.

The purpose of this manual is to provide you with information about the

OPTIMIZER Integra CCM-D 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 Guardio Charger.

2.0 THE OPTIMIZER INTEGRA CCM-D SYSTEM

The OPTIMIZER Integra CCM-D system is comprised of the following

components:

•OPTIMIZER Integra CCM-D Implantable Pulse Generator (IPG)

•Guardio Charger

Note: In certain circumstances, the Vesta Charger may be substituted

for the Guardio Charger

2.1 OPTIMIZER Integra CCM-D Implantable Pulse

Generator

The OPTIMIZER Integra CCM-D Implantable Pulse Generator

(IPG) is a medical device used for the treatment of heart failure. In

addition, it functions as an implantable cardioverter defibrillator

(ICD) for the prevention of sudden cardiac death (SCD). It is

typically implanted under the skin in the upper left chest.

Connected to the OPTIMIZER Integra CCM-D IPG are two

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 Integra CCM-D 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. One of the two

leads has an external coil that may deliver a shock when the IPG

detects an abnormal heart rhythm. In addition, the OPTIMIZER

Integra CCM-D IPG can provide emergency short-term pacing

support by delivering a low-voltage electrical pulse to your heart if

it beats too slowly.

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 Integra CCM-D IPG is powered by a

rechargeable battery to extend its service life. A charger

specifically designed to recharge the battery of the OPTIMIZER

Integra CCM-D IPG will be provided to you after your implant

surgery.

The OPTIMIZER Integra CCM-D IPG also contains a non-

rechargeable battery that provides the extra power needed to

deliver defibrillation shocks to your heart if it detects a life-

threatening heart rhythm.

The expected life of the OPTIMIZER Integra CCM-D IPG is limited

by the expected service life of its batteries.

With weekly charging of your OPTIMIZER Integra CCM-D IPG,

the rechargeable battery inside the OPTIMIZER Integra CCM-D

IPG should provide you with at least 20 years of service.

The non-rechargeable battery inside the OPTIMIZER Integra

CCM-D IPG should provide you with at least 20 years of service if

the following conditions are met:

•your device delivers a limited number of shocks per year

•your device is not required to deliver pacing therapy for an

extended period of time

•the rechargeable battery in your OPTIMIZER Integra

CCM-D IPG is fully recharged on a weekly basis

Your OPTIMIZER Integra CCM-D IPG will need to be replaced

when the battery voltage of its non-rechargeable battery drops

below a certain level. Your OPTIMIZER Integra CCM-D IPG

monitors this voltage and will provide advance warning to your

healthcare provider regarding the state of its non-rechargeable

battery whenever your device is interrogated during a follow up

visit.

Your OPTIMIZER Integra CCM-D IPG will need to be replaced

when its rechargeable 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 Integra CCM-D IPG 7

days before your scheduled routine checkup. During your

checkup, your doctor may evaluate the charge capacities of both

batteries in your OPTIMIZER Integra CCM-D IPG.

Figure 1: OPTIMIZER Integra CCM-D IPG

2.2 Guardio Charger

The Guardio Charger is powered by a rechargeable battery and is

specifically designed for use with the OPTIMIZER Integra CCM-D

IPG. After your implant procedure, you will be provided with a

Guardio Charger and receive instructions on its usage. Please

proceed to Section 7.0 for more details about your Guardio

Charger.

Figure 2: Guardio Charger

3.0 INDICATIONS OF USE

The OPTIMIZER INTEGRA CCM-D System is indicated for the prevention

of sudden cardiac death, improvement of quality of life, and 6-minute walk

in Stage C or D heart failure patients who remain symptomatic despite

being on guideline-directed medical therapy (GDMT), are not indicated for

Cardiac Resynchronization Therapy (CRT), and have heart failure with

reduced left ventricular ejection fraction (LVEF ≤ 40%).

The OPTIMIZER Integra CCM-D system delivers non-excitatory CCM

signals to the heart and performs ICD and short-term pacemaker

functions.

4.0 POTENTIAL COMPLICATIONS

4.1 Complications Associated with Implantation

As with any surgical procedure, the implantation of the

OPTIMIZER Integra CCM-D 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 Integra CCM-D 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.

Table 1: Risks Associated with Implantation

Common (more frequently than 5%)

•Post-procedural pain, bruising, and discomfort at insertion site

•Bleeding

•Infection at site of insertion

•Pocket hematoma

•Movement of leads

•Movement of IPG in the pocket

Uncommon (less frequently than 5%) but serious

•Chest trauma (such as a collapsed lung or bleeding into the

chest)

•Inappropriate detection of arrhythmia resulting in an

unnecessary ICD shock delivered

Indice

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