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Summary of Contents for Impulse Dynamics OPTIMIZER Lite System
- Page 1 ® OPTIMIZER Lite System * * * For the Treatment of Moderate to Severe Heart Failure Patient’s Manual Federal (US) law restricts this device to sale by or on the order of a physician Part No.: 13-250-007-US Rev. 01...
- Page 3 Impulse Dynamics. The OPTIMIZER Lite 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...
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Page 5: Table Of Contents
TABLE OF CONTENTS INTRODUCTION ..................1 THE OPTIMIZER LITE SYSTEM ..............1 OPTIMIZER Lite Implantable Pulse Generator ........2 Vesta Charger ..................3 INDICATIONS OF USE ................4 POTENTIAL COMPLICATIONS ..............4 Complications Associated with Implantation ........4 Complications Associated with Device / Charger Operation ....6 FOLLOWING IMPLANTATION .............. - Page 6 7.8.3 Termination of Charging Session Due to Charging IPG Timeout ................. 24 7.8.4 Termination of Charging Session Due to Low Charger Battery Level ..................24 Vesta Charger Placement When Not Being Used for Device Charging ......................25 7.10 Frequency of Charging Sessions ............. 25 7.11 Communications with Your OPTIMIZER Lite IPG ......
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Page 7: Introduction
THE OPTIMIZER LITE SYSTEM The OPTIMIZER Lite system is comprised of the following components: • OPTIMIZER Lite Implantable Pulse Generator (IPG) •... -
Page 8: Optimizer Lite Implantable Pulse Generator
OPTIMIZER Lite Implantable Pulse Generator The OPTIMIZER Lite Implantable Pulse Generator (IPG) is a medical device intended for the treatment of moderate to severe heart failure. It is typically implanted under the skin in the upper left or right chest. Connected to the OPTIMIZER Lite IPG are two (or optionally three) cardiac leads that your doctor will insert through a large vein and into the heart during the implantation process. -
Page 9: Vesta Charger
Figure 1: OPTIMIZER Lite IPG Vesta Charger The Vesta Charger is powered by a rechargeable battery and is specifically designed for use with the OPTIMIZER Lite 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: Indications Of Use
INDICATIONS OF USE The OPTIMIZER Lite System, which delivers CCM™ therapy, is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not indicated for Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%. - Page 11 • Arrhythmia (irregular heartbeat, including heartbeats that are too slow or too fast) • Tricuspid valve damage (the valve between the right upper and lower chambers of the heart that prevents blood from flowing back into the upper chamber), possibly leading to tricuspid valve regurgitation or leakage •...
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Page 12: Complications Associated With Device / Charger Operation
Complications Associated with Device / Charger Operation Complications associated with device/charger operation include, but are not limited to: • An OPTIMIZER Lite IPG may not properly sense and deliver CCM signals due to a software or hardware problem, necessitating replacement. •... -
Page 13: Living With Your Optimizer Lite Ipg
Note: If you have a slender build, your implanted device may appear more prominently under the skin. If this is the case, extra care should be taken to avoid any direct blows to your implant site. • Contact your doctor if you notice anything unexpected or unusual such as new symptoms. -
Page 14: How Other Devices May Affect Your Optimizer Lite Ipg
How Other Devices May Affect Your OPTIMIZER Lite IPG In general, household appliances in good repair and personal communication devices held 10 inches or more from your implanted OPTIMIZER Lite IPG should not affect its operation. However, you should be cautious when in the vicinity of devices that generate strong electrical or magnetic fields. -
Page 15: The Importance Of Your Implanted Medical Device Identification Card
• Therapeutic Ultrasound • Lithotripsy • Nuclear Magnetic Resonance (NMR) • Magnetic Resonance Imaging (MRI) Caution: MRI conditional compatible healthcare providers should consult device labeling for proper conditions for use. Caution: Your OPTIMIZER Lite IPG should either be deactivated or closely monitored prior to and during any medical treatment in which electrical current is passed through the body. -
Page 16: Vesta Charger
VESTA CHARGER System Components Your Vesta Charger System consists of the following components: Charging Wand Carrying Case 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 charging wand cable clip) –... -
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 Lite IPG • Buzzer: An internal buzzer that produces beeping tones to inform you of a condition that requires action •... -
Page 18: Description
Description Your Vesta Charger is designed to charge the battery of your OPTIMIZER Lite 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 call the 24-hour Support Hotline, reminders to charge your implanted device, etc.). -
Page 19: Removal And Installation Of The Plug Adapter
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
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 21: Charging Your Vesta Charger
Charging Your Vesta Charger Note: Charging your Vesta Charger and charging your OPTIMIZER Lite 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 Lite IPG. Note: Inspect the AC Adapter for any damage before each use. - 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.
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Page 24: Charging Your Optimizer Lite Ipg
2. Replace the protective cover flap over the power input connector of your Vesta Charger. Charging Your OPTIMIZER Lite IPG Note: Charging your device will take approximately 90 minutes (if charge weekly) Warning: If your OPTIMIZER Lite 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 7.13.
- 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 the Charging IPG Battery icon (see icon image on the right) depicts the current charge level of the battery in your OPTIMIZER Lite IPG. See Table 2. Table 2: OPTIMIZER Lite IPG Battery Charge Levels IPG Battery Icon IPG Battery Charge Level...
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Page 28: Termination Of The Charging Session
Note: If the recharging of your OPTIMIZER Lite IPG cannot be completely recharged in one session, repeat the charging sessions (at least daily) until it is fully charged. 9. When the battery of your OPTIMIZER Lite 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). -
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 Lite 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 Lite IPG to return to its baseline temperature. -
Page 30: Termination Of Charging Session Due To Charging Ipg Timeout
7.8.3 Termination of Charging Session Due to Charging IPG Timeout If the duration of the charging session exceeds 5 hours, 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 Lite 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 Lite Ipg
before it resumes delivering CCM therapy. Once your OPTIMIZER Lite IPG has been recharged, it will automatically resume CCM therapy delivery with its previously programmed settings. 7.11 Communications with Your OPTIMIZER Lite When your Vesta Charger is connected to the AC Adapter, it will attempt to communicate with its paired IPG every 10 minutes. - Page 33 If your Vesta Charger is not able to successfully complete downloading data from your OPTIMIZER Lite IPG, it will display the IPG Data Download Error screen, indicated by a flashing “X” at the center of the screen (see Figure 25). Should this happen, your Vesta Charger will retry downloading data from your OPTIMIZER Lite IPG in a few minutes.
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Page 34: Call Doctor Alert Codes
7.12 Call Doctor Alert Codes In addition to charging your OPTIMIZER Lite IPG, your Vesta Charger is also able to notify you of an alert condition that requires action. Alert conditions are triggered by the detection of certain events by your OPTIMIZER Lite IPG or Vesta Charger. - Page 35 The Call Doctor Alert screen will be followed by the Snooze Buzzer Alert screen (see Figure 29), or if at night, the Snooze Alert screen (see Figure 30). Figure 29: Snooze Buzzer Figure 30: Snooze Alert Screen Alert Screen If a Call Doctor Alert Code appears on the screen of your Vesta Charger, take note of the code that is displayed and then press the Power Button on your Vesta Charger to snooze the activated alert.
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Page 36: Cleaning
7.13 Cleaning Warning: Always unplug the AC Adapter from your Vesta Charger prior to cleaning. The exterior surface of your Vesta Charger should only be cleaned with disinfectant wipes as needed. Caution: DO NOT use solvents or cleaning cloths impregnated with chemical cleaning agents. -
Page 37: Disposal
For proper operation, your Vesta Charger should be used only under the following environmental conditions: • Ambient Temperature: 50°F to 81°F • Relative Humidity: 20% to 75% • Atmospheric Pressure: 20.73 inHg to 31.39 inHg Note: Your Vesta Charger is designed for indoor use. If necessary, move to a location that meets these conditions prior to using your Vesta Charger. -
Page 38: Frequently Asked Questions
FREQUENTLY ASKED QUESTIONS 1. What does my OPTIMIZER Lite IPG do? Your OPTIMIZER Lite IPG monitors your heart rhythm and delivers Cardiac Contractility Modulation (CCM) therapy pulses at a particular time when the heart contracts. These signals are intended to increase the strength of each contraction, thus improving your heart failure symptoms. -
Page 39: Statement Of Fcc Compliance
APPENDIX I Statement of FCC Compliance FCC Compliance of the OPTIMIZER Lite IPG The OPTIMIZER Lite 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 Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference... -
Page 40: 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 15 – Radio Frequency Devices • 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 41 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. The Vesta Charger is marketed under FCC ID: 2AY43- GDCH1.
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Page 42: Electromagnetic Immunity
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY OF THE OPTIMIZER LITE IMPLANTABLE PULSE GENERATOR The OPTIMIZER Lite IPG, part of the OPTIMIZER Lite System, is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Lite IPG must ensure that it is used within the specified environment. - Page 43 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 Per standard Does not exhibit Seek the advice of your Clause 4.7 - malfunction which physician or other qualified Protection from...
- 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 frequency requirements, and the reduced sensitivity of circuits at microwave frequencies. ISO 14117:2019 Per standard Does not exhibit Inform your physician or Clause 6.1 - malfunction which other qualified health Protection of the persists after the provider that you are device from removal of the implanted with an...
- Page 46 through the archway at a normal pace. Radiofrequency identification (RFID) readers: • Maintain separation from wall unit (reader) and the implanted device. • Do not lean against the reader. Radiofrequency identification (RFID) and checkout counter tag deactivators: • Maintain an arm’s length separation from the deactivator’s surface.
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Page 47: Electromagnetic Immunity Of The Vesta Charger
• If essential performance is lost due to electromagnetic disturbances, the Vesta Charger shall not be able to charge any IPG. The Vesta Charger, part of the OPTIMIZER Lite 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 IEC 61000-4- interruptions, it is recommended to power the Vesta Charger from an uninterruptible power supply. Power line 30 A/m 30 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-...
- 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.
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Page 50: Electromagnetic Emissions
EMMISSIONS OF THE OPTIMIZER LITE IPG PURSUANT TO: FCC 47 CFR 95 Subpart I – Medical Device Radio Communications Service The OPTIMIZER Lite Implantable Pulse Generator, part of the OPTIMIZER Lite System, is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Lite Implantable Pulse Generator must ensure that it is used within the specified environment. - Page 51 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The OPTIMIZER Lite Implantable Pulse Generator, part of the OPTIMIZER Lite System, is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Lite Implantable Pulse Generator must ensure that it is used within the specified environment.
- 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 Lite Implantable Pulse Generator, part of the OPTIMIZER Lite System, is intended for use in an electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Lite Implantable Pulse Generator must ensure that it is used within the specified environment.
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Page 53: Electromagnetic Emissions From The Vesta Charger
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 54 EMMISSIONS OF THE VESTA CHARGER PURSUANT TO: FCC 47 CFR Part 15 – Radio Frequency Devices The Vesta Charger, part of the OPTIMIZER Lite 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 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 Lite 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 9kHz to 30MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Lite 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 57 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Lite 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 58 402 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 Lite 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 59 - Collateral Standard: Electromagnetic disturbances – Requirements and tests The Vesta Charger, part of the OPTIMIZER Lite 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.
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Page 60: Wireless Technology
APPENDIX II Wireless Technology RF wireless technology is used in the communication between an OPTIMIZER Lite Implantable Pulse Generator (IPG) and the Vesta 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 61 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 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...
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Page 62: Quality Of Service (Qos) For Communications Between The Vesta Charger And The Optimizer Lite Ipg
Quality of Service (QoS) for Communications between the Vesta Charger and the OPTIMIZER Lite IPG MedRadio in the MICS sub-band (402 to 405 MHz) wireless technology enables communication between the OPTIMIZER Lite 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 63 One illuminated bar indicates degraded QoS which may require a longer charging time. Zero illuminated bars on the Coupling Level icon accompanied by an audible beeping tone indicates poor placement of the charging wand. If the charging wand is not repositioned onto the implant site within 20 seconds, the Vesta Charger will emit 3 long beeping tones, display the Charging IPG Coupling Error screen, and then shut off.
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Page 64: Troubleshooting Wireless Connection Between Optimizer Lite Ipg And Vesta Charger
Troubleshooting Wireless Connection between OPTIMIZER Lite IPG and Vesta Charger If you experience issues with establishing a wireless connection between the OPTIMIZER Lite IPG and the Vesta Charger, try the following: • Whenever the Vesta Charger is not being used to charge the OPTIMIZER Lite IPG, place it in an area that is frequented by the patient (e.g., bedside table in the bedroom), connected to its... - 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 Lite 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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