Impulse Dynamics OPTIMIZER Smart Mini Patient Manual
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Impulse Dynamics OPTIMIZER Smart Mini Patient Manual

For the treatment of moderate to severe heart failure
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OPTIMIZER™ Smart Mini
System
* * *
For the Treatment of
Moderate to Severe Heart Failure
Patient's Manual
Part No.: 13-250-004-EU Rev. 02

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Summary of Contents for Impulse Dynamics OPTIMIZER Smart Mini

  • Page 1 OPTIMIZER™ Smart Mini System * * * For the Treatment of Moderate to Severe Heart Failure Patient’s Manual Part No.: 13-250-004-EU Rev. 02...
  • 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

    IMPORTANT MEDICAL NOTICE Any serious incident should be reported to the manufacturer Impulse Dynamics by emailing QualityComplaints@impulse-dynamics.com. According to MDR 2017/745, a ‘serious incident’ means any incident that directly or indirectly led, might have led, or might lead to any of the following: a) The death of a patient, user, or other person, b) The temporary or permanent serious deterioration of a patient’s,...
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  • Page 7: Introduction

    Congratulations on receiving your OPTIMIZER Smart Mini System. 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.

  • Page 8: Optimizer Smart Mini Implantable Pulse Generator

    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

    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.

  • Page 10: Potential Complications

    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 11: Complications Associated With Device / Charger Operation

    You may also be sensitive to one or more of the materials used in your OPTIMIZER Smart Mini IPG that are exposed to the tissues of the body (histotoxic reaction). Though rare, this may require the removal of the device.

  • Page 12: Following Implantation

     A Vesta Charger may not function as designed due to a software or hardware problem and not charge your OPTIMIZER Smart Mini IPG as intended. A replacement charger will be required. FOLLOWING IMPLANTATION You must become actively involved in your own recovery by following your doctor’s instructions carefully, including:...

  • 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 Any such interference detected by your OPTIMIZER Smart Mini IPG may cause false detection of your heartbeat and improper timing of CCM therapy delivery. 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.

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

    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 immediately detectable. Caution: Store anti-theft systems and airport security screening systems normally will not harm your OPTIMIZER Smart Mini IPG.

  • 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 1.5 m (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...

  • 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: Electromagnetic Immunity

    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 41 power supply 25/30 cycles 25/30 cycles Charger requires input lines as uninterrupted operation Interruptions: Interruptions: defined in during power mains 100% reduction for 100% reduction for IEC 61000-4- interruptions, it is 250/300 cycles 250/300 cycles recommended to power the Vesta Charger from an uninterruptible power supply.
  • Page 42 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 43: Electromagnetic Immunity Of The Optimizer Smart Mini Ipg

    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 44 ISO 14117:2019 Per standard Device Maintain 6 inches (15 cm) Clause 4.6 - operation is distance between household Protection from unaffected per magnets or items containing static magnetic standard magnets (e.g. headphones, fields of flux density exercise equipment up to 1 mT containing magnets, etc.) and implant ISO 14117:2019...
  • Page 45 ISO 14117:2019 Per standard Functions as it Seek the advice of your Clause 4.9 - Test did before the physician or other qualified requirements for the test without health provider regarding frequency range of further Transmitting Devices and 385 MHz ≤ ƒ ≤ 3000 adjustment Cellular and Mobile Phones after application...
  • Page 46 Protection of the malfunction you are implanted with an device from damage which persists OPTIMIZER Smart Mini IPG caused by high- after the and that they should consult frequency surgical removal of the the IPG’s Instructions for Use...
  • Page 47 (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 48: Electromagnetic Emissions

    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 49 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 50 405 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 51 402 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 52 - 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 53: Electromagnetic Emissions From The Optimizer Smart Mini Ipg

    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 54 405 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 55: Wireless Technology

    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 56 Amplitude (slow to optimize coupling, no data transmitted) Radiated Power < 0.6 W Range 5 mm to 40 mm OPTIMIZER Smart Mini IPG Wireless Nominal Specifications Characteristic Nominal OPTIlink MICS MedRadio Frequency Band 402 – 405 MHz Medical Implant Communication Service (MICS)

  • Page 57: 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 58 IPG is within 1.5 m (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 59: 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 61 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 62 Medications: OPTIMIZER Smart Mini Implantable Pulse Generator Model No.: Serial No.: Lead 1 Model No.: Lead 2 Model No.: Lead 3 Model No.:...
  • Page 63 NOTES:...

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