AIM HIGHer OPTIMIZER Patient Manual
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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. 01

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Summary of Contents for 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...
  • Page 2 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...

  • Page 3: Table Of Contents

    General Expectations ................. 7 Effect on Your Activities ..............7 Medications ..................7 How Other Devices May Affect Your OPTIMIZER Smart Mini IPG ..7 The Importance of Your Implanted Medical Device Identification Card ......................9 VESTA CHARGER ..................10 System Components ................
  • Page 4 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 ..................

  • Page 5: Important Medical Notice

    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.
  • Page 6 Implanted Medical Device Identification Card (back)

  • Page 7: 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 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.

  • Page 9: Vesta Charger

    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).
  • 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 Uncommon (between 1-5%) •...

  • 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 during implantation, necessitating re-operation.

  • 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

    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 Caution: Your OPTIMIZER Smart Mini IPG should not be directly exposed to therapeutic ultrasound or therapeutic radiation. This type of exposure may damage the device that may not be...

  • 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

    Figure 3: Vesta Charger System Components • Vesta Charger (with attached charging wand and charging wand cable clip) – used to charge your OPTIMIZER Smart Mini IPG. • AC Adapter – used to charge the internal battery of your Vesta Charger.

  • Page 17: Features

    Vesta Charger for charging as well as short- range communications with your OPTIMIZER Smart Mini • Radio Transceiver: Device used by your Vesta Charger for long-range communications (between zero and at least 5 ft) with your OPTIMIZER Smart Mini IPG Graphical Display Power Button...

  • Page 18: Description

    Charging may be performed over clothing. The manner in which inductive energy transfer is used to charge the battery of your OPTIMIZER Smart Mini IPG is as follows: 1. Electrical energy from the battery of your Vesta Charger...

  • Page 19: Removal And Installation Of The Plug Adapter

    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

    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!
  • Page 25 4. The charging process begins by displaying the IPG Data Download screen as your Vesta Charger downloads information from your OPTIMIZER Smart Mini IPG. The animated arrow pointing to the charger icon indicates that your Charger is actively downloading information from your implanted device.
  • Page 26 6. After the data download has been completed, the Charging IPG Status screen will be displayed, indicating that your Vesta Charger has begun actively charging your OPTIMIZER Smart Mini IPG. See Figure 15. The Coupling Level icon ( ) at the center of the Charging IPG Status screen will show anywhere from zero to four illuminated bars.
  • Page 27 Coupling Level icon are illuminated. Note: If weekly charging of your OPTIMIZER Smart Mini IPG is not performed as instructed, charging the battery of your OPTIMIZER Smart Mini IPG may take longer. If the...

  • 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

    Smart Mini IPG, the temperature of your IPG is monitored during the charging process. If the reported temperature of your OPTIMIZER Smart Mini IPG at the beginning of the charging session is outside the acceptable temperature range or if the temperature of your implanted...

  • 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

    6.10 Frequency of Charging Sessions The optimal performance of the rechargeable battery in your OPTIMIZER Smart Mini IPG can only be ensured if the battery is fully recharged every week. It is not important which day or what time you choose to charge your OPTIMIZER Smart Mini IPG, but it is recommended that you do not let more than seven days pass between charge sessions.

  • 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.
  • 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...

  • 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

    The battery inside your Vesta Charger is expected to have a service life of 5 years. If your Vesta Charger is unable to fully charge your OPTIMIZER Smart Mini IPG after the Charger’s internal battery has been fully charged, please contact the 24-hour Support Hotline (1-855-246-4437) to obtain a replacement charger.

  • 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

    However, there maybe instances where the OPTIMIZER Smart Mini IPG or one of its implanted leads may not function as intended. If such an instance occurs, your doctor will explain the reason(s) to you and schedule you for replacement surgery.
  • 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

    APPENDIX I Statement of FCC Compliance 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 Communications Service This device may not interfere with stations operating in the 400.150-406.000 MHz band in the Meteorological...

  • Page 41: Fcc Compliance Of The Vesta Charger

    FCC Compliance of the Vesta Charger The Vesta Charger has been tested to the following FCC rules: • 47 CFR Part 18 – Industrial, Scientific, and Medical Equipment • 47 CFR Part 95 Subpart I - Medical Device Radio Communications Service This device complies with part 18 of the FCC Rules.

  • Page 42: Electromagnetic Immunity

    NOTE: In case of emergency, placing a pacemaker magnet over the implant site of the OPTIMIZER Smart Mini IPG and maintaining it in close proximity to the device for at least two cardiac cycles (2–3 seconds), sets the OPTIMIZER Smart Mini IPG into Magnet Mode, suspending CCM therapy.
  • Page 43 ISO 14117:2019 Per standard Device operation Maintain 6 inches (15 cm) Clause 4.6 - is unaffected per distance between Protection from standard household magnets or items static magnetic containing magnets (e.g. fields of flux headphones, exercise density up to 1 equipment containing magnets, etc.) and implant ISO 14117:2019...
  • Page 44 ISO 14117:2019 Per standard Functions as it did Seek the advice of your Clause 4.9 - Test before the test physician or other qualified requirements for without further health provider regarding the frequency adjustment after Transmitting Devices and range of 385 MHz application of the Cellular and Mobile ≤...
  • Page 45 OPTIMIZER Smart Mini IPG by high-frequency test signal per and that they should consult the IPG’s Instructions for surgical exposure standard Use regarding...
  • Page 46 (Normal CCM delivery or inhibition of CCM delivery due to interference is permissible, but inappropriately triggering of CCM delivery by interference is not allowed. The OPTIMIZER Smart Mini IPG is not a pacemaker, CRT, or ICD device. As such, the criteria of ISO 14117:2019 were adapted to be applicable to CCM.

  • Page 47: Electromagnetic Immunity Of The Vesta Charger

    Vesta Charger The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
  • Page 48 Power line 3 A/m 3 A/m Power line frequency frequency magnetic fields (50/60 Hz) magnetic should be at levels expected fields (50/60 in a typical home healthcare, Hz) as defined business, or hospital in IEC 61000- environment. Conducted RF 3 V r.m.s outside 3 V r.m.s outside Portable and mobile RF as defined in...
  • Page 49 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 50: Electromagnetic Emissions

    EMMISSIONS OF THE OPTIMIZER SMART MINI IPG PURSUANT TO: FCC 47 CFR 95 Subpart I - Medical Device Radio Communications Service The OPTIMIZER Smart Mini Implantable Pulse Generator, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below.
  • Page 51 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The OPTIMIZER Smart Mini Implantable Pulse Generator, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below.
  • Page 52 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU The OPTIMIZER Smart Mini Implantable Pulse Generator, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below.

  • Page 53: Electromagnetic Emissions From The Vesta Charger

    EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: 47 CFR Part 18 – Industrial, Scientific, and Medical Equipment The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
  • Page 54 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. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
  • Page 55 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
  • Page 56 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
  • Page 57 - Collateral Standard: Electromagnetic disturbances - Requirements and tests The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.

  • Page 58: Wireless Technology

    402–405 MHz) of the MedRadio Band. RF wireless technology is also used to transcutaneously transmit energy from the Vesta Charger to recharge the OPTIMIZER Smart Mini IPG at the 13.56 MHz ISM frequency. The transmission range is specified at a maximum of 1.5 inches between the Charger’s coil and the IPG’s receiving coil.
  • Page 59 Vesta Charger Wireless Nominal Specifications Characteristic Nominal MICS MedRadio 402 – 405 MHz Medical Implant Frequency Band 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 60: 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...
  • Page 61 IPG is within 5 ft of the Vesta Charger for a few minutes. If the Vesta Charger and the OPTIMIZER Smart Mini IPG do not communicate within a programmable time period, the patient may see the “Long Time Without Downloading Data From IPG”...

  • Page 62: 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 charge the OPTIMIZER Smart Mini IPG, place it in an area that is frequented by the patient (e.g.,...
  • Page 63 THIS PAGE INTENTIONALLY LEFT BLANK...
  • Page 65 IMPORTANT INFORMATION: Electrophysiologist: Address: City: Country: Postal Code: Telephone No.: Cardiologist: Address: City: Country: Postal Code: Telephone No.: Hospital: Address: City: Country: Postal Code: Telephone No.:...
  • Page 66 Medications: OPTIMIZER Smart Mini Implantable Pulse Generator Model No.: Serial No.: Lead 1 Model No.: Lead 2 Model No.: Lead 3 Model No.:...
  • Page 67 NOTES:...

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