Impulse Dynamics OPTIMIZER Integra CCM-D Patient Manual
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Impulse Dynamics OPTIMIZER Integra CCM-D Patient Manual

Implantable pulse generator
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OPTIMIZER
Integra CCM-D
System
* * *
Patient's Manual
Limited by United States (Federal) law to investigational use
Part No.: 12-250-005-US Rev. 00

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Summary of Contents for Impulse Dynamics OPTIMIZER Integra CCM-D

  • Page 1 ® OPTIMIZER Integra CCM-D System * * * Patient’s Manual Limited by United States (Federal) law to investigational use Part No.: 12-250-005-US Rev. 00...
  • Page 2 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...

  • Page 3: Table Of Contents

    LIVING WITH YOUR OPTIMIZER INTEGRA CCM-D IPG ......7 General Expectations ................. 7 Effect on Your Activities ..............7 Medications ..................7 How Other Devices May Affect Your OPTIMIZER Integra CCM-D IPG ......................8 The Importance of Your Implanted Medical Device Identification Card ......................10 GUARDIO CHARGER ................
  • Page 4 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 ..................

  • Page 5: Important Medical Notice

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

  • Page 7: 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.
  • Page 8 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.

  • Page 9: Guardio Charger

    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...

  • Page 10: Indications Of Use

    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 ≤...
  • Page 11 • Death (in rare cases) The OPTIMIZER Integra CCM-D IPG uses its leads to detect the electrical activity of your heart as well as deliver CCM therapy, shocks, and short-term emergency pacing. Complications that can affect the lead’s ability to perform this function may occur. These include: •...

  • Page 12: Complications Associated With Device / Charger Operation

    Charger Operation Complications associated with device/charger operation include, but are not limited to: • An OPTIMIZER Integra CCM-D IPG may not properly sense and deliver CCM signals due to a software or hardware problem, necessitating replacement. • An OPTIMIZER Integra CCM-D IPG may detect environmental interference and inappropriately deliver CCM therapy or antitachycardia therapy.

  • Page 13: Living With Your Optimizer Integra Ccm-D Ipg

    CCM-D IPG General Expectations You will be able to feel your OPTIMIZER Integra CCM-D 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: How Other Devices May Affect Your Optimizer Integra Ccm-D Ipg

    CCM and ICD therapy whenever it is in the presence of a strong magnetic field. Once your OPTIMIZER Integra CCM-D IPG is no longer in the presence of a strong magnetic field, ICD therapy delivery is once again automatically enabled but CCM therapy delivery will continue to be disabled for 24 hours.
  • Page 15 Always inform your doctor that you have an implanted OPTIMIZER Integra CCM-D IPG before you undergo the following procedures: • Surgery where electrocautery is going to be used •...

  • Page 16: The Importance Of Your Implanted Medical Device Identification Card

    Device Identification Card Following your implantation surgery, your doctor will provide you with an Implanted Medical Device Identification Card indicating that you are implanted with an OPTIMIZER Integra CCM-D Implantable Pulse Generator. 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 17: Guardio Charger

    Figure 5: Guardio Charger System Components • Guardio Charger (with attached charging wand and charging wand cable clip) – used to charge your OPTIMIZER Integra CCM-D IPG. • AC Adapter – used to charge the internal battery of your Guardio Charger.

  • Page 18: Features

    • Radio Transceiver: Device used by your Guardio Charger for long-range communications (between zero and at least 5 ft) with your OPTIMIZER Integra CCM-D • Cellular Modem: Modem is used to send data downloaded from your OPTIMIZER Integra CCM-D IPG to...

  • Page 19: Description

    The manner in which inductive energy transfer is used to charge the battery of your OPTIMIZER Integra CCM-D IPG is as follows: 1. The electronic circuitry of your Guardio Charger takes the electrical energy from its battery and converts it into an oscillating electromagnetic field in a primary coil of the charging wand.

  • Page 20: Removal And Installation Of The Plug Adapter

    Removal and Installation of the Plug Adapter Your Guardio 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. 7.5.1 Removal of the Plug Adapter To remove the Plug Adapter from the AC Adapter,...

  • Page 21: Installation Of The Plug Adapter

    7.5.2 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 22: Charging Your Guardio Charger

    Charging Your Guardio Charger Note: Charging your Guardio Charger and charging your OPTIMIZER Integra CCM-D IPG CANNOT be done at the same time. Always charge the internal battery of your Guardio Charger before attempting to charge the battery of your OPTIMIZER Integra CCM-D IPG.
  • Page 23 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 Guardio Charger (see Figure 10) and then insert the DC output connector into the power input connector.
  • Page 24 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 Guardio Charger. When the Charging Self-Charge Success screen is displayed on your Guardio Charger (see Figure 12), the battery in your Guardio Charger is fully charged, as indicated by the checkmark above the charge level indicator in the center of the screen.

  • Page 25: Charging Your Optimizer Integra Ccm-Dipg

    Charging Your OPTIMIZER Integra CCM-D Note: Charging your device will take approximately 90 minutes (if charge weekly) Warning: If your OPTIMIZER Integra CCM-D IPG is not charged regularly, it will shut down when the battery becomes depleted, suspending CCM therapy delivery!
  • Page 26 4. The charging process begins by displaying the IPG Data Download screen as your Guardio Charger downloads information from your OPTIMIZER Integra CCM-D IPG. The animated arrow pointing to the charger icon indicates that your Charger is actively downloading information from your implanted device.
  • Page 27 6. After the data download has been completed, the Charging IPG Status screen will be displayed, indicating that your Guardio Charger has begun actively charging your OPTIMIZER Integra CCM-D IPG. See Figure 17. The Coupling Level icon ( ) at the center of the Charging IPG Status screen will show anywhere from zero to four illuminated bars.
  • Page 28 (see icon image on the right) depicts the current charge level of the rechargeable battery in your OPTIMIZER Integra CCM-D IPG. See Table Table 2: OPTIMIZER Integra CCM-D IPG Battery Charge Levels IPG Battery Icon IPG Battery Charge Level...
  • Page 29 Note: If weekly charging of your OPTIMIZER Integra CCM-D IPG is not performed as instructed, charging the battery of your OPTIMIZER Integra CCM-D IPG may take longer. If the recharging of your OPTIMIZER Integra CCM-D IPG cannot be completely recharged in one session, repeat the charging sessions (at least daily) until it is fully charged.

  • Page 30: Termination Of The Charging Session

    Note: If you wish to resume charging your OPTIMIZER Integra CCM-D 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 Integra CCM-D IPG to return to its baseline temperature.

  • Page 31: Termination Of Charging Session Due To Ipg Temperature

    Integra CCM-D IPG, the temperature of your IPG is monitored during the charging process. If the reported temperature of your OPTIMIZER Integra CCM-D IPG at the beginning of the charging session is outside the acceptable temperature range or if the temperature of...

  • Page 32: Termination Of Charging Session Due To Low Charger Battery Level

    Used for Device Charging Whenever your Guardio Charger is not being used to charge your OPTIMIZER Integra CCM-D 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 33: Frequency Of Charging Sessions

    7.10 Frequency of Charging Sessions The optimal performance of the rechargeable battery in your OPTIMIZER Integra CCM-D 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 Integra CCM-D IPG, but it is recommended that you do not let more than seven days pass between charge sessions.

  • Page 34: Communications With Your Optimizer Integra Ccm-D Ipg

    Note: If the voltage of the rechargeable battery in your OPTIMIZER Integra CCM-D IPG drops below a certain level, ICD functionality of your implanted OPTIMIZER Integra CCM-D IPG will continue to be maintained until the non-rechargeable battery in the OPTIMIZER Integra CCM-D IPG is also depleted.
  • Page 35 “X” at the center of the screen (see Figure 27). Should this happen, your Guardio Charger will retry downloading data from your OPTIMIZER Integra CCM-D IPG in a few minutes. Figure 27: IPG Data Download Error Screen If your Guardio Charger and your implanted OPTIMIZER Integra...

  • Page 36: Call Doctor Alert Codes

    Note: “Doctor” in the context of this manual is referring to the doctor mentioned in the clinical trial informed consent. In addition to charging your OPTIMIZER Integra CCM-D IPG, your Guardio Charger is also able to notify you of an alert condition that requires action.
  • Page 37 Guardio Charger. Then, unless the alert code displayed is “B1” or “B9”, proceed to charge your implanted OPTIMIZER Integra CCM-D IPG. If the Call Doctor Alert Code “B31” is displayed, it means •...

  • Page 38: Cleaning

    2. If this code is still displayed after the Charging Wand has been placed over your implanted OPTIMIZER Integra CCM-D IPG and the charging process has been restarted, please call the 24- hour Support Hotline (866-312-5370). 7.13 Cleaning Warning: Always unplug the AC Adapter from your Guardio Charger prior to cleaning.

  • Page 39: Storage And Handling

    The battery inside your Guardio Charger is expected to have a service life of at least 5 years. If your Guardio Charger is unable to fully charge your OPTIMIZER Integra CCM-D IPG after the Charger’s internal battery has been fully charged, please call the 24-hour Support Hotline (866-312-5370) to obtain a replacement Guardio Charger.

  • Page 40: Replacement Of Your Optimizer Integra Ccm-D Ipg

    The need to replace your OPTIMIZER Integra CCM-D IPG because the rechargeable battery is unable to hold a charge is not expected within the warranty period.
  • Page 41 3. Will my OPTIMIZER Integra CCM-D IPG ever need to be replaced? Your OPTIMIZER Integra CCM-D IPG is powered by a rechargeable battery that should provide you with at least 20 years of service. Using the instructions in this manual, you will be shown you how to recharge your device.
  • Page 42 THIS PAGE INTENTIONALLY LEFT BLANK...

  • Page 43: Electromagnetic Immunity

    The OPTIMIZER Integra CCM-D IPG, part of the OPTIMIZER Integra CCM-D System is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Integra CCM-D IPG must ensure that it is used within the specified environment.
  • Page 44 • Exercise caution in ISO 14117:2019 Per clauses Does not exhibit Clause 4.3 - 4.3.2.1, 4.3.2.2, malfunction which the vicinity of Protection from and 4.3.2.3 of persists after the equipment that persisting standard removal of the generates strong malfunction electromagnetic electrical or attributable to test signal per...
  • Page 45 ISO 14117:2019 Per standard Does not exhibit Seek the advice of your Clause 4.8 - malfunction which physician or other qualified Protection from persists after the health provider regarding AC magnetic field removal from the Environmental exposure in the field per standard Conditions, Industrial range of 1 kHz to Machinery, and Home...
  • Page 46 OPTIMIZER Integra CCM-D by high-frequency test signal per IPG and that they should consult the IPG’s surgical exposure standard Instructions for Use...
  • Page 47 GTRI E3 Per E3 protocol Per E3 protocol Seek the advice of your Representative physician or other qualified Security and health provider regarding Logistical Store Anti-Theft Systems Systems/Airport Security (Electronic article Screening Systems surveillance, Electronic Article metal detectors, Surveillance (EAS) RFID) systems, such as those found at department stores:...

  • Page 48: Electromagnetic Immunity Of The Guardio Charger

    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 Integra CCM-D IPG does not fall within the clear definitions of ISO 14117:2019. As such, the criteria of ISO 14117:2019 were adapted to be applicable to CCM-D.
  • Page 49 Electrical fast ± 2 kV for mains ± 2 kV for mains Mains power quality should transient / power supply power supply be that of a typical home burst as healthcare, business, or ± 1 kV for in- ± 1 kV for in- defined in hospital environment.
  • Page 50 d = 1.17√P 80 MHz to 800 Radiated RF 10 V/m: 80 MHz to 10 V/m: 80 MHz to as defined in 2.7 GHz, 80% 2.7 GHz, 80% IEC 61000-4- 1kHz AM 1kHz AM d = 2.33√P 800 MHz to 2.5 3: 2006 +A1: 2007 +A2: Where “P”...
  • Page 51 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Guardio Charger Recommended separation distances between portable and mobile RF communications equipment and the Guardio Charger The Guardio Charger should be used in an electromagnetic environment with limited radiated RF noise.

  • Page 52: Electromagnetic Emissions

    EMMISSIONS OF THE OPTIMIZER INTEGRA CCM-D IPG PURSUANT TO: FCC 47 CFR 95 Subpart I – Medical Device Radio Communications Service The OPTIMIZER Integra CCM-D Implantable Pulse Generator, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below.
  • Page 53 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The OPTIMIZER Integra CCM-D Implantable Pulse Generator, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Integra CCM-D Implantable Pulse Generator must ensure that it is used within the specified environment.
  • Page 54 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU The OPTIMIZER Integra CCM-D Implantable Pulse Generator, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below.

  • Page 55: Electromagnetic Emissions From The Guardio Charger

    Electromagnetic Emissions from the Guardio Charger The Guardio Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Warning: The Guardio Charger must not be used onboard an aircraft. Warning: Permission must be requested from a ship’s crew prior to using the Guardio Charger onboard a ship.
  • Page 56 EMMISSIONS OF THE GUARDIO CHARGER PURSUANT TO: FCC 47 CFR Part 15 – Radio Frequency Devices The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.
  • Page 57 EMMISSIONS OF THE GUARDIO CHARGER PURSUANT TO: FCC 47 CFR 95 Subpart I – Medical Device Radio Communications Service The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.
  • Page 58 9kHz to 30MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.
  • Page 59 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.
  • Page 60 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.
  • Page 61 - Collateral Standard: Electromagnetic disturbances – Requirements and tests The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Guardio Charger must ensure that it is used within the specified environment.

  • Page 62: Wireless Technology

    Wireless Technology RF wireless technology is used in the communication between an OPTIMIZER Integra CCM-D Implantable Pulse Generator (IPG) and the Guardio Charger. It occurs through an encrypted channel over an RF link that complies with the requirements of the Medical Implant Communication System (MICS) (range specified to 2 m, 402–405 MHz) of the MedRadio Band.
  • Page 63 Guardio 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 240 kHz Modulation Radiated Power -20.6 dBm EIRP Range 0 to at least 1.5 m Transcutaneous Energy Transfer Frequency Band 13.56 MHz...

  • Page 64: Quality Of Service (Qos) For Communications Between The Guardio Charger And The Optimizer Integra Ccm-D Ipg

    CCM-D IPG MedRadio in the MICS sub-band (402 to 405 MHz) wireless technology enables communication between the OPTIMIZER Integra CCM-D IPG and the Guardio Charger. The requirements for the Quality of Service (QoS) vary depending on the use environment (operating room, recovery room, clinic, and home environment).
  • Page 65 The Guardio Charger is configured to communicate with the OPTIMIZER Integra CCM-D IPG at least once a day. This communication occurs whenever the IPG is within 1.5 m (5 ft) of the Guardio Charger for a few minutes.

  • Page 66: Troubleshooting Wireless Connection Between Optimizer Integra Ccm-D Ipg And Guardio Charger

    Troubleshooting Wireless Connection between OPTIMIZER Integra CCM-D IPG and Guardio Charger If you experience issues with establishing a wireless connection between the OPTIMIZER Integra CCM-D IPG and the Guardio Charger, try the following: • Whenever the Guardio Charger is not being used...
  • Page 67 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 68 Medications: OPTIMIZER Integra CCM-D Implantable Pulse Generator Model No.: Serial No.: Lead 1 Model No.: Lead 2 Model No.:...
  • Page 69 NOTES:...

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