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Impulse Dynamics AIM HIGHer OPTIMIZER Patient Manual

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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
Part No.: 12-250-004-US Rev. 00

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Summary of Contents for Impulse Dynamics AIM HIGHer OPTIMIZER

  • Page 1 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 Part No.: 12-250-004-US Rev.
  • Page 2 50 Lake Center Executive Parkway 401 Route 73 N Bldg. 50 Marlton, NJ 08053-3425 OPTIMIZER™ and CCM™ are trademarks of Impulse Dynamics. is a US registered trademark property of Impulse Dynamics ® OPTIMIZER The information in this document can be changed without prior notice.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS IMPORTANT MEDICAL NOTICE ................i INTRODUCTION ..................1 THE OPTIMIZER SMART MINI SYSTEM ............ 1 OPTIMIZER Smart Mini Implantable Pulse Generator ....... 1 Vesta Charger ..................3 POTENTIAL COMPLICATIONS ..............3 Complications Associated with Implantation ........3 Complications Associated with Device / Charger Operation ....
  • Page 4 6.8.3 Termination of Charging Session Due to Charging IPG Timeout 6.8.4 Termination of Charging Session Due to Low Charger Battery Level ..................24 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 ....

  • Page 5: Important Medical Notice

    IMPORTANT MEDICAL NOTICE 24-hour Support Hotline: 866-312-5370 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.
  • Page 6 Implanted Medical Device Identification Card (back)

  • Page 7: Introduction

    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 ≥...
  • Page 8 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.

  • Page 9: Vesta Charger

    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 7.0 for more details about your Vesta Charger.
  • Page 10 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 •...

  • Page 11: Complications Associated With Device / Charger Operation

    The OPTIMIZER Smart Mini IPG uses its leads to detect the electrical activity of your heart. Complications that can affect the lead’s ability to perform this function may occur. These include: A lead may become dislodged from where it was placed •...

  • Page 12: Following Implantation

    FOLLOWING IMPLANTATION You must become actively involved in your own recovery by following your doctor’s instructions carefully, including: • Report any redness, swelling, or drainage from your incision to your doctor. Avoid lifting heavy objects until instructed by your doctor. •...

  • Page 13: Living With Your Optimizer Smart Mini Ipg

    LIVING WITH YOUR OPTIMIZER SMART MINI IPG General Expectations You will be able to feel your OPTIMIZER Smart Mini IPG beneath the skin. Normal body movement will cause no harm to it or the attached leads. However, it is important that you not try to move or turn your implanted IPG.
  • Page 14 You should avoid getting too close to equipment or devices that contain strong magnets (e.g., stereo speakers) or leaning over an open automobile engine compartment, as the alternator generates a strong electromagnetic field. Your OPTIMIZER Smart Mini IPG contains a magnetic switch that, when exposed to a strong magnet for 3-5 seconds, will disable CCM therapy delivery.

  • Page 15: The Importance Of Your Implanted Medical Device Identification Card

    Caution: Store anti-theft systems and airport security screening systems normally will not harm your OPTIMIZER Smart Mini IPG. However, do not linger around the equipment. Before going through airport security screening, it is recommended that you show your Implanted Medical Device Identification Card to security personnel for review.

  • Page 16: Vesta Charger

    VESTA CHARGER System Components Your Vesta Charger System consists of the following components: Carrying Case Charging Wand Cable Clip AC Adapter with attached U.S. E.U. Plug Plug Adapter Adapter Vesta Charger Charging Wand Figure 3: Vesta Charger System Components Vesta Charger (with attached charging wand and •...

  • Page 17: Features

    Features Your Vesta Charger has the following features: Graphical Display: Display screen used by your Vesta • Charger to communicate information to you Power Button: Press-button switch used to initiate • charging of your OPTIMIZER Smart Mini IPG Buzzer: An internal buzzer that produces beeping tones •...

  • Page 18: Description

    Description Your Vesta Charger is designed to charge the battery of your OPTIMIZER Smart Mini IPG with minimal intervention while ensuring your safety during the charging process. In addition, your Vesta Charger is programmed to display alerts and other messages that may require action on your part (e.g., Call Doctor Alert Codes that require you to contact your doctor, reminders to charge your implanted device, etc…).

  • Page 19: Removal And Installation Of The Plug Adapter

    energy. That electrical energy is used to charge the battery of your OPTIMIZER Smart Mini IPG. Removal and Installation of the Plug Adapter Your Vesta Charger system includes an AC Adapter installed with a U.S. Plug Adapter. If a different Plug Adapter is required, the AC Adapter allows the option of removing and installing a different Plug Adapter.

  • Page 20: Installation Of The Plug Adapter

    6.5.2 Installation of the Plug Adapter To install the Plug Adapter onto the AC Adapter, perform the following steps: 1. While holding the AC Adapter in your hand, insert the Plug Adapter into its corresponding slot on the AC Adapter. 2.

  • Page 21: Charging Your Vesta Charger

    Charging Your Vesta Charger Note: Charging your Vesta Charger and charging your OPTIMIZER Smart Mini IPG CANNOT be done at the same time. Always charge the internal battery of your Vesta Charger before attempting to charge the battery of your OPTIMIZER Smart Mini IPG.
  • Page 22 3. Obtain the AC Adapter from the Carrying Case and rotate its DC output connector until the red dot on its connector is visible. 4. Line up the red dot on the DC output connector of the AC Adapter with the red line on the power input connector of your Vesta Charger (see Figure 8) and then insert the DC output connector into the power input connector.
  • Page 23 5. Attach the location-specific Plug Adapter to the AC Adapter and then plug the AC Adapter into the wall outlet to begin charging the internal battery of your Vesta Charger. When the Charging Self-Charge Success screen is displayed on your Vesta Charger (see Figure 10), the battery in your Vesta Charger is fully charged, as indicated by the checkmark above the charge level indicator in the center of the screen.

  • Page 24: Charging Your Optimizer Smart Mini Ipg

    2. Replace the protective cover flap over the power input connector of your Vesta Charger. Charging Your OPTIMIZER Smart Mini IPG Note: Charging your device will take approximately 90 minutes (if charge weekly) Warning: If your OPTIMIZER Smart Mini IPG is not charged regularly, it will shut down when the battery becomes depleted, suspending CCM therapy delivery! Note: Your Vesta Charger cannot be used to charge your...
  • Page 25 Figure 12: Pressing the Power Button on the Charger Note: If any alerts have been triggered, the Call Doctor Alert screen may be displayed. If a Call Doctor Alert Code appears on the screen of your Vesta Charger, follow the instructions described in Section 6.12.
  • Page 26 5. When your Vesta Charger has successfully completed downloading the data, it will display the IPG Data Download Success screen accompanied by 3 short beeping tones. The flashing checkmark indicates that your Vesta Charger was able to successfully able to download information from your implanted device.
  • Page 27 Figure 16: Charging IPG Coupling Error Screen 7. The number of bars on Charging IPG Battery icon (see icon image on the right) depicts the current charge level of the battery in your OPTIMIZER Smart Mini IPG. See Table 2. Table 2: OPTIMIZER Smart Mini IPG Battery Charge Levels IPG Battery Icon...

  • Page 28: Termination Of The Charging Session

    9. When the battery of your OPTIMIZER Smart Mini IPG is fully charged, your Vesta Charger will emit 3 short beeping tones and display the IPG Charging Successfully Completed screen, indicated by the flashing checkmark in the center of the screen (see Figure 17). Your Vesta Charger will then shut off automatically.

  • Page 29: Termination Of Charging Session Due To Ipg Temperature

    Alternatively, you can remove the charging wand from your implant site, which will cause your Vesta Charger to time out and shut off automatically. Note: If you wish to resume charging your OPTIMIZER Smart Mini IPG after you terminate a charging session, please wait for approximately 10 minutes before initiating a new charging session to allow the temperature of your OPTIMIZER Smart Mini IPG to return to its baseline...

  • Page 30: Termination Of Charging Session Due To Charging Ipg Timeout

    6.8.3 Termination of Charging Session Due to Charging IPG Timeout If the duration of the charging session exceeds 5 hours ± 5 minutes, your Vesta Charger will emit 3 long beeping tones and display the Charging IPG Timeout Error screen, indicated by a flashing hourglass icon in the center of the screen (see Figure 20).

  • Page 31: Vesta Charger Placement When Not Being Used For Device Charging

    Vesta Charger Placement When Not Being Used for Device Charging Whenever your Vesta Charger is not being used to charge your OPTIMIZER Smart Mini IPG, it should be placed in an area frequented by you (e.g., bedside table in your bedroom), connected to its AC Adapter, and the AC Adapter plugged into the wall outlet.

  • Page 32: Communications With Your Optimizer Smart Mini Ipg

    If the battery voltage in your OPTIMIZER Smart Mini IPG drops below a certain level, CCM therapy delivery is automatically suspended. If this occurs, your OPTIMIZER Smart Mini IPG will need to be recharged before it resumes delivering CCM therapy. Once your OPTIMIZER Smart Mini IPG has been recharged, it will automatically resume CCM therapy delivery with its previously programmed settings.
  • Page 33 When your Vesta Charger has successfully completed downloading data from your OPTIMIZER Smart Mini IPG, it will display the IPG Data Download Success screen, indicated by the flashing checkmark at the center of the screen. See Figure 24. Figure 24: IPG Data Download Success Screen If your Vesta Charger is not able to successfully complete downloading data from your OPTIMIZER Smart Mini IPG, it will display the IPG Data Download Error screen, indicated by a...

  • Page 34: Call Doctor Alert Codes

    If you see this message displayed by your Vesta Charger, attempt to use your Vesta Charger to charge your OPTIMIZER Smart Mini IPG. If you can successfully charge your implanted OPTIMIZER Smart Mini IPG, then the alert screen should no longer be displayed by your Vesta Charger.
  • Page 35 If a detected alert condition is associated with a Call Doctor Alert, your Vesta Charger will emit a beeping tone and display a Call Doctor Alert Screen, with a flashing exclamation point at the center of the screen and a Call Doctor Code (preceded by a letter denoting the IPG model code).

  • Page 36: Cleaning

    If the Call Doctor Alert Code “A32” is displayed, it means • that you are attempting to use your Vesta Charger on an unpaired device. If this code is displayed by your Vesta Charger, perform the following steps: 1. Verify that the Vesta Charger you are using is the one that was assigned to you and then restart the charging process.

  • Page 37: Storage And Handling

    6.15 Storage and Handling Your Vesta Charger System should not be exposed to excessively hot or cold conditions. Store your Vesta Charger System in a cool, dry place, with your Vesta Charger connected to its AC Adapter and the AC Adapter plugged into the wall outlet. Do not leave your Vesta Charger System in your car or outdoors for extended periods of time.

  • Page 38: Replacement Of Your Optimizer Smart Mini Ipg

    REPLACEMENT OF YOUR OPTIMIZER SMART MINI IPG Your implanted OPTIMIZER Smart Mini IPG contains a rechargeable battery and the need to replace it because the battery is unable to hold a charge is not expected within the warranty period. However, there maybe instances where the OPTIMIZER Smart Mini IPG or one of its implanted leads may not function as intended.
  • Page 39 With regular charging, should your OPTIMIZER Smart Mini IPG reach its 20th year of service, your doctor will need to assess the condition of the battery during your routine check-up visits. To help facilitate this battery assessment, please fully charge your OPTIMIZER Smart Mini IPG 7 days before your scheduled routine check-up visit.

  • Page 40: Statement Of Fcc Compliance

    Changes or modifications to the Vesta Charger not approved by Impulse Dynamics could void the user’s authority to operate the equipment under FCC rules.

  • Page 41: Fcc Compliance Of The Optimizer Smart Mini Ipg

    Note: The Vesta Charger can interrupt RFIDs or other communications systems that utilize the 13.56MHz ISM band. FCC Compliance of the OPTIMIZER Smart Mini IPG The OPTIMIZER Smart Mini IPG has been tested to the following FCC rule: 47 CFR Part 95 Subpart I - Medical Device Radio •...

  • Page 42: Electromagnetic Immunity

    Electromagnetic Immunity Electromagnetic Immunity of the Vesta Charger GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY OF THE VESTA CHARGER Essential Performance of the Vesta Charger: The Vesta Charger shall not charge the OPTIMIZER Smart Mini IPG • inappropriately. The patient shall be made aware of inappropriate charging either by an explicit •...
  • Page 43 IEC 61000-4- 250/300 cycles 250/300 cycles interruptions, it is recommended to power the Vesta Charger from an uninterruptible power supply. Power line Power line frequency 3 A/m 3 A/m magnetic fields (50/60 Hz) frequency should be at levels expected magnetic fields (50/60 in a typical home healthcare, Hz) as defined...
  • Page 44 NOTES: a - Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be theoretically predicted with accuracy. An electromagnetic site survey should be taken into consideration to assess the electromagnetic environment due to fixed RF transmitters.

  • Page 45: Electromagnetic Immunity Of The Optimizer Smart Mini Ipg

    Electromagnetic Immunity of the OPTIMIZER Smart Mini IPG GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY OF THE OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR The OPTIMIZER Smart Mini IPG, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Smart Mini IPG must ensure that it is used within the specified environment.
  • Page 46 Per standard Maintain 6 inches (15 cm) ISO 14117:2019 Device Clause 4.6 - distance between household operation is unaffected per Protection from magnets or items containing standard magnets (e.g. headphones, static magnetic fields of flux density exercise equipment containing magnets, etc.) and up to 1 mT implant Per standard...
  • Page 47 Per standard Seek the advice of your ISO 14117:2019 Functions as it did before the physician or other qualified Clause 4.9 - Test test without health provider regarding requirements for the Transmitting Devices and frequency range of further 385 MHz ≤ ƒ ≤ 3000 adjustment Cellular and Mobile Phones after application...
  • Page 48 frequencies, the expected performance of EMI control features implemented to meet lower- frequency requirements, and the reduced sensitivity of circuits at microwave frequencies. Per standard ISO 14117:2019 Does not Inform your physician or other Clause 6.1 - exhibit qualified health provider that you are implanted with an Protection of the malfunction...
  • Page 49 the exits for businesses such as retailers. • Do not lean against the system’s sensors. Metal detector archways: • Do not stop or linger in a walk- through archway; simply walk through the archway at a normal pace. Radiofrequency identification (RFID) readers: •...

  • Page 50: Electromagnetic Emissions

    Electromagnetic Emissions Electromagnetic Emissions from the Vesta Charger The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Warning: The Vesta Charger must not be used onboard an aircraft. Warning: Permission must be requested from a ship’s crew prior to using the Vesta Charger onboard a ship.
  • Page 51 FCC 47 CFR 95 Subpart I - Medical Device Radio Communications Service GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: FCC - 47 CFR 95 Subpart I - Medical Device Radio Communications Service The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below.
  • Page 52 ETSI EN 301 839 GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: ETSI EN 301 839 V2.1.1 - Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz;...
  • Page 53 ETSI EN 301 489-1 and ETSI EN 301 489-27 GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility ETSI EN 301 489-27 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;...
  • Page 54 voltage power supply network which supplies buildings used for domestic purposes. IEC 60601-1-2 2014 GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: IEC 60601-1-2 2014, Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an...

  • Page 55: Electromagnetic Emissions From The Optimizer Smart Mini Ipg

    Electromagnetic Emissions from the OPTIMIZER Smart Mini IPG The OPTIMIZER Smart Mini IPG must emit electromagnetic energy in order to perform its intended function when communicating with the Intelio Programmer or the Vesta Charger. Nearby electronic equipment may be affected. FCC 47 CFR 95 Subpart I - Medical Device Radio Communications Service GUIDELINES AND MANUFACTURER’S DECLARATION –...
  • Page 56 ETSI EN 301 839 GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE OPTIMIZER SMART MINI IPG PURSUANT TO: ETSI EN 301 839 V2.1.1 - Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz;...

  • Page 57: Wireless Technology

    ETSI EN 301 489-1 and ETSI EN 301 489-27 GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF THE OPTIMIZER SMART MINI IPG PURSUANT TO: ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility ETSI EN 301 489-27 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;...
  • Page 58 Vesta Charger Wireless Nominal Specifications Characteristic Nominal MICS MedRadio Frequency Band 402 – 405 MHz Medical Implant Communication Service (MICS) Medical Device Radio Communication Service (MedRadio) Bandwidth < 145 kHz Modulation Radiated Power < 25 µW E.I.R.P. Range 0 to at least 1.5 m Transcutaneous Energy Transfer Frequency Band 13.56 MHz...

  • Page 59: Quality Of Service (Qos) For Communications Between The Vesta Charger And The Optimizer Smart Mini Ipg

    Quality of Service (QoS) for Communications between the Vesta Charger and the OPTIMIZER Smart Mini IPG MedRadio in the MICS sub-band (402 to 405 MHz) wireless technology enables communication between the OPTIMIZER Smart Mini IPG and the Vesta Charger. The requirements for the Quality of Service (QoS) vary depending on the use environment (operating room, recovery room, clinic, and home environment).
  • Page 60 Vesta Charger. If the attempt to charge the OPTIMIZER Smart Mini IPG with the Vesta Charger is unsuccessful, the Impulse Dynamics representative should be contacted.

  • Page 61: Troubleshooting Wireless Connection Between Optimizer Smart Mini Ipg And Vesta Charger

    Troubleshooting Wireless Connection between OPTIMIZER Smart Mini IPG and Vesta Charger If you experience issues with establishing a wireless connection between the OPTIMIZER Smart Mini IPG and the Vesta Charger, try the following: Whenever the Vesta Charger is not being used to •...
  • Page 63 IMPORTANT INFORMATION: Electrophysiologist: Address: City: Postal Code: Country: Telephone No.: Cardiologist: Address: City: Postal Code: Country: Telephone No.: Hospital: Address: City: Postal Code: Country: Telephone No.:...
  • Page 64 Medications: OPTIMIZER Smart Mini Implantable Pulse Generator Model No.: Serial No.: Lead 1 Model No.: Lead 2 Model No.: Lead 3 Model No.:...
  • Page 65 NOTES:...

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