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Содержание AIM HIGHer OPTIMIZER

Страница 1: ...ev 00 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 ...

Страница 2: ...nged without prior notice No part of this manual may be reproduced or transmitted in any way or by any means either electronic or mechanical for any purpose without the prior express written consent of 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...

Страница 3: ...r Activities 7 5 3 Medications 7 5 4 How Other Devices May Affect Your OPTIMIZER Smart Mini IPG 7 5 5 The Importance of Your Implanted Medical Device Identification Card 9 6 0 VESTA CHARGER 10 6 1 System Components 10 6 2 Features 11 6 3 Description 12 6 4 Charging Method 12 6 5 Removal and Installation of the Plug Adapter 13 6 5 1 Removal of the Plug Adapter 13 6 5 2 Installation of the Plug Adap...

Страница 4: ...I IPG 32 8 0 FREQUENTLY ASKED QUESTIONS 32 APPENDIX I 34 Statement of FCC Compliance 34 FCC Compliance of the Vesta Charger 34 FCC Compliance of the OPTIMIZER Smart Mini IPG 35 Electromagnetic Immunity 36 Electromagnetic Immunity of the Vesta Charger 36 Electromagnetic Immunity of the OPTIMIZER Smart Mini IPG 39 Electromagnetic Emissions 44 Electromagnetic Emissions from the Vesta Charger 44 Elect...

Страница 5: ...t importance to an attending physician and will assist in expediting any emergency medical care you may require 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 mad...

Страница 6: ...ii Implanted Medical Device Identification Card back ...

Страница 7: ...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 2 0 THE OPTIMIZER SMART MINI SYSTEM The OPTIMIZER Smart Mini system is comprised of the following components OPTIMIZER Smart Mini Implantable Pulse Generator IPG Vesta Charger 2 1 OPTIMIZER Smart Mini Implantable Pulse Generator The OPTIMIZER S...

Страница 8: ...ice 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 Your OPTIMIZER Smart Mini IPG will need to be replaced when its battery after being fully recharged can no longer maintain enough charge to deliver CCM therapy for an entire week without becoming...

Страница 9: ...ions Associated with Implantation As with any surgical procedure the implantation of the OPTIMIZER Smart Mini IPG involves some degree of risk This section is intended to provide you with an explanation of the various potential complications associated with having a device implanted These potential complications are not unique to the OPTIMIZER Smart Mini IPG as they may also occur during the impla...

Страница 10: ...t 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 Vessel trauma perforation dissection or rupture Thrombosis formation of blood clots in the veins Damage to the specific type of heart ti...

Страница 11: ...he implant life of a lead Surgical correction is typically required 3 2 Complications Associated with Device Charger Operation Complications associated with device charger operation include but are not limited to An OPTIMIZER Smart Mini IPG may not properly sense and deliver CCM signals due to a software or hardware problem necessitating replacement An OPTIMIZER Smart Mini IPG may detect environme...

Страница 12: ... rubbing the device or the surrounding chest area If directed by your doctor limit any arm movements that may affect the implanted lead system Avoid rough contact that could result in blows to the implant site If you fall or are in an accident that results in an impact to the implant site contact your doctor Note If you have a slender build your implanted device may appear more prominently under t...

Страница 13: ... proper operation of your OPTIMIZER Smart Mini IPG In general the implantation of your OPTIMIZER Smart Mini IPG should not require you to alter the use of any medication 5 4 How Other Devices May Affect Your OPTIMIZER Smart Mini IPG In general household appliances in good repair and personal communication devices held 25 cm 10 in or more from your implanted OPTIMIZER Smart Mini IPG should not affe...

Страница 14: ...re there is industrial machinery or radio transmitters including ham radios and mobile radios Always inform your doctor that you have an implanted OPTIMIZER Smart Mini IPG before you undergo the following procedures Surgery where electrocautery is going to be used A procedure involving Radiofrequency RF Ablation Medical Diathermy Cardioversion Therapeutic Radiation Therapeutic Ultrasound Lithotrip...

Страница 15: ...ing that you are implanted with an OPTIMIZER Smart Mini 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 In a medical emergency the Implanted Medical Device Identification Card contains information of great importance to an attending physician and will assist in expediting any e...

Страница 16: ...rge your OPTIMIZER Smart Mini IPG AC Adapter used to charge the internal battery of your Vesta Charger E U U S Plug Adapters plug adapters for the AC Adapter allowing the AC Adapter to be connected to wall outlets in the E U and the U S Carrying Case used to store and transport your Vesta Charger System Carrying Case AC Adapter with attached U S Plug Adapter Charging Wand E U Plug Adapter Vesta Ch...

Страница 17: ... buzzer that produces beeping tones to inform you of a condition that requires action Charging Wand Wand containing a coil and circuitry used by your Vesta Charger for charging as well as short range communications with your OPTIMIZER Smart Mini IPG 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 ...

Страница 18: ... system 6 4 Charging Method The charging method utilized by your Vesta Charger to charge the battery of your OPTIMIZER Smart Mini IPG is called inductive energy transfer Since magnetic fields can easily pass through the skin with little to no resistance the charging method used by your Vesta Charger is a proven and effective way to transfer energy to your implanted device Charging may be performed...

Страница 19: ...emoving and installing a different Plug Adapter 6 5 1 Removal of the Plug Adapter To remove the Plug Adapter from the AC Adapter perform the following steps 1 Grasp the AC Adapter in your hand and place your thumb on the ridged area below the plug prongs of the Plug Adapter 2 Using your thumb push up on the Plug Adapter to unlock it from the AC Adapter See Figure 5 3 Slide the Plug Adapter upwards...

Страница 20: ...ing steps 1 While holding the AC Adapter in your hand insert the Plug Adapter into its corresponding slot on the AC Adapter 2 Using your index finger push down on the Plug Adapter until it is fully inserted onto the AC Adapter See Figure 6 Figure 6 Installing the Plug Adapter Push Down to Install Plug Adapter ...

Страница 21: ...AC Adapter is needed Warning Only use the AC Adapter provided with your Vesta Charger to charge the battery in your Vesta Charger Otherwise damage to your Vesta Charger may result To connect the AC Adapter to your Vesta Charger and begin charging its internal battery perform the following steps 1 Turn your Vesta Charger around so that the back of the Charger is facing up 2 Remove the protective co...

Страница 22: ...or 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 Figure 8 Alignment of the DC Connectors Once the AC Adapter is connected to your Vesta Charger it will display the Charger Self Charge Status screen See Figure 9 Figure 9 Charger Self Charge Status Screen ...

Страница 23: ...tery in your Vesta Charger is fully charged as indicated by the checkmark above the charge level indicator in the center of the screen Figure 10 Charger Self Charge Success Screen To disconnect the AC Adapter from your Vesta Charger perform the following steps 1 Hold and pull back on the metal sleeve of the DC output connector to disconnect the connector from your Vesta Charger See Figure 11 Figur...

Страница 24: ... be used onboard an aircraft Warning When onboard a ship request permission from the ship s crew prior to using your Vesta Charger To charge the battery of your OPTIMIZER Smart Mini IPG perform the following steps 1 Assume a stationary comfortable sitting position ideally reclining at a 45 angle such as on a sofa or armchair 2 Determine the location of your OPTIMIZER Smart Mini IPG typically right...

Страница 25: ...sta Charger follow the instructions described in Section 6 12 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 See Figure 13 Figure 13 IPG Data Download Scree...

Страница 26: ...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 Reposition the charging wand until at least two bars of the Coupling Level icon are illuminated Figure 15 Charging IPG Status Screen Note Zero illuminated bars on the Coupling Level icon accompanied by an audible beeping tone indicates...

Страница 27: ...IMIZER Smart Mini IPG is being charged Note It is recommended that you remain stationary during the charging process If the charging wand becomes significantly displaced during charging the Coupling Level icon will show zero illuminated bars and your Vesta Charger will begin to emit an audible beeping tone If this occurs please reposition the charging wand until at least two bars of the Coupling L...

Страница 28: ...y then remove the Vesta charging wand from your implant site and undrape the wand cable from around your neck 11 Reconnect the AC Adapter to your Vesta Charger as described in Section 6 9 6 8 Termination of the Charging Session 6 8 1 Early Termination of Charging Session To terminate a charging session before it has been completed press and hold the Power Button down for one second and then releas...

Страница 29: ...ER 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 OPTIMIZER Smart Mini IPG remaining consistently high for more than 10 minutes while it is being charged then your Vesta Charger...

Страница 30: ...ely 10 minutes before initiating a new charging session Figure 20 Charging IPG Timeout Error Screen 6 8 4 Termination of Charging Session Due to Low Charger Battery Level If the battery charge level of your Vesta Charger drops below 10 during a charging session your Vesta Charger will emit 3 long beeping tones and display the Low Charger Battery Alert screen indicated by an empty battery icon with...

Страница 31: ...our 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 If your Vesta Charger is not used to perform a charging session on your OPTIMIZER Smart Mini IPG within the time period ...

Страница 32: ...unicate with your implanted OPTIMIZER Smart Mini IPG at least once a day This communication occurs whenever you are within 1 5 m 5 ft of your Vesta Charger for a few minutes When this occurs you will first see your Vesta Charger display the IPG Data Download screen indicated by the animated arrow pointing to the charger icon see Figure 23 This indicates that your Vesta Charger is actively attempti...

Страница 33: ...creen 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 Smart Mini IPG in a few minutes Figure 25 IPG Data Download Error Screen If your Vesta Charger and your implanted OPTIMIZER Smart Mini IPG do not communicate within the time period set by your doctor your Vesta Charger will emit a beeping t...

Страница 34: ...ZER Smart Mini 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 Smart Mini IPG or Vesta Charger When an alert condition occurs your OPTIMIZER Smart Mini IPG is programmed to send this information to your Vesta Charger If a detected alert condition is associated with a Dir...

Страница 35: ... 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 Afterwards use the information below to determine your next course of action If the Call Doctor Alert Code A19 is displayed please call the 24 ...

Страница 36: ...uld only be cleaned with disinfectant wipes as needed Caution DO NOT use solvents or cleaning cloths impregnated with chemical cleaning agents Warning DO NOT attempt to clean the electrical connector of your Vesta Charger Warning DO NOT submerge any part of your Vesta Charger in water Damage to the unit may result 6 14 Maintenance Your Vesta Charger does not contain any user serviceable parts If y...

Страница 37: ...our Vesta Charger should be used only under the following environmental conditions Ambient Temperature 10 C to 27 C 50 F to 81 F Relative Humidity 20 to 75 Atmospheric Pressure 700 hPa to 1060 hPa 20 73 inHg to 31 39 inHg If necessary move to a location that meets these conditions prior to using your Vesta Charger 6 16 Disposal If your Vesta Charger is no longer needed you may return it to your do...

Страница 38: ...Mini 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 Your OPTIMIZER Smart Mini IPG is programmed to your specific requirements by your doctor using an external programmer connected to a wand ...

Страница 39: ...this battery assessment please fully charge your OPTIMIZER Smart Mini IPG 7 days before your scheduled routine check up visit In addition there is a risk that a problem will develop with a component or a lead necessitating surgery to replace the IPG or lead s Since your OPTIMIZER Smart Mini IPG is not a life sustaining device you are unlikely to be placed at risk if your device should not operate ...

Страница 40: ...ause harmful interference to stations operating in the 400 150 406 000 MHz band in the Meteorological Aids i e transmitters and receivers used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference that may cause undesired operation This transmitter shall be used on...

Страница 41: ...diocommunication Service in part 95 of the FCC Rules and must not cause harmful interference to stations operating in the 400 150 406 000 MHz band in the Meteorological Aids i e transmitters and receivers used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference t...

Страница 42: ...kV and 15 kV Contact Discharge 8 kV Air Discharge 2 kV 4 kV 8 kV and 15 kV Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humidity should be 30 or greater Electrical fast transient burst as defined in IEC 61000 4 4 2 kV for mains power supply 1 kV for in output lines 2 kV for mains power supply 1 kV for in output lines Mains power quality shou...

Страница 43: ...ds between 0 15 MHz and 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P d 1 17 P 80 MHz to 800 MHz d 2 33 P 800 MHz to 2 5 GHz Where P is the maximum output power rati...

Страница 44: ...arger should be used in an electromagnetic environment with limited radiated RF noise The customer or user of the Vesta Charger can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communications equipment transmitters and the Vesta Charger recommended below which is determined by the maximum output power of the communications equipment R...

Страница 45: ...ead current 16 6 Hz to 20 kHz Test 1 and Test 2 per standard Induced lead current does not exceed limits for Test 1 and Test 2 per standard Seek the advice of your physician or other qualified health provider regarding Environmental Conditions Exercise caution in the vicinity of equipment that generates strong electrical or electromagnetic fields Do not enter an area with posted warnings advising ...

Страница 46: ...esonance Imaging MRI Exercise caution in the vicinity of equipment that generates strong magnetic fields Do not enter an area with posted warnings advising pacemaker patients or patients with other types of implantable devices not to approach ISO 14117 2019 Clause 4 8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz Per standard Does not exhibit malfunction which persist...

Страница 47: ...lds Do not enter an area with posted warnings advising pacemaker patients or patients with other types of implantable devices not to approach Interference may occur in the vicinity of equipment marked with the following symbol ISO 14117 2019 Clause 5 Testing above frequency of 3000 MHz Standard does not require testing of devices above 3 GHz Electromagnetic fields 3 GHz are not expected to interfe...

Страница 48: ...e from damage caused by external defibrillators Per standard Does not exhibit malfunction which persists after the removal of the electromagnetic test signal per standard Inform your physician or other qualified health provider that you are implanted with an OPTIMIZER Smart Mini IPG and that they should consult the IPG s Instructions for Use regarding Defibrillation and Cardioversion GTRI E3 Repre...

Страница 49: ...y the OPTIMIZER Smart Mini IPG Normal CCM delivery or inhibition of CCM delivery due to interference is permissible but inappropriately triggering of CCM delivery by interference is not allowed b 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 c This guidance shall not be considered the exclusive or only ...

Страница 50: ...LINES AND MANUFACTURER S DECLARATION ELECTROMAGNETIC 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 Emissions ...

Страница 51: ...at it is used within the specified environment Emissions Test Compliance Electromagnetic environment guidelines Duration of Transmissions Complies with clause 95 2557 The Vesta Charger must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Frequency Monitoring Complies with clause 95 2559 Frequency Accuracy Complies with clause 95 256...

Страница 52: ...tic environment as specified below The customer or user of the Vesta Charger must ensure that it is used within the specified environment Emissions Test Compliance Electromagnetic environment guidelines Frequency Error Complies with clause 5 3 1 The Vesta Charger must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Occupied Bandwidt...

Страница 53: ...arger must ensure that it is used within the specified environment There may be potential difficulties in ensuring electromagnetic compatibility in other environments due to conducted as well as radiated disturbances Emissions Test Compliance Electromagnetic environment guidelines Radiated Emissions EN 55032 2012 AC 2013 Class B The INTELIO Programmer with INTELIO Programming Wand must emit electr...

Страница 54: ...environments due to conducted as well as radiated disturbances Emissions Test Compliance Electromagnetic environment guidelines Radiated Emissions CISPR 11 2009 A1 2010 Group 1 Class B The Vesta Charger must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Conducted Emissions CISPR 11 2009 A1 2010 FCC 18 Group 2 The Vesta Charger mus...

Страница 55: ...electromagnetic environment as specified below The patient implanted with the OPTIMIZER Smart Mini Implantable Pulse Generator must ensure that it is used within the specified environment Emissions Test Compliance Electromagnetic environment guidelines Duration of Transmissions Complies with clause 95 2557 The OPTIMIZER Smart Mini IPG must emit electromagnetic energy in order to perform its intend...

Страница 56: ...The patient implanted with the OPTIMIZER Smart Mini Implantable Pulse Generator must ensure that it is used within the specified environment Emissions Test Compliance Electromagnetic environment guidelines Frequency Error Complies with clause 5 3 1 The OPTIMIZER Smart Mini IPG must emit electromagnetic energy in order to perform its intended function when communicating with the Intelio Programmer ...

Страница 57: ...hat it is used within the specified environment Emissions Test Compliance Electromagnetic environment guidelines Radiated Emissions EN 55032 2012 AC 2013 Class B 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 Wireless Technology RF...

Страница 58: ...ansfer Frequency Band 13 56 MHz Industrial Scientific and Medical radio band ISM Bandwidth 0 014 MHz Modulation 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 Medical Device Rad...

Страница 59: ... begin by displaying the IPG Data Download and IPG Data Download Success screens After the data download has been completed the Charging IPG Status screen is displayed by the Vesta Charger The Coupling Level icon whose number of illuminated bars is proportional to the proximity of the charging wand to the implanted OPTIMIZER Smart Mini IPG is indicative of the Quality of Service QoS for the transc...

Страница 60: ...o communicate with the OPTIMIZER Smart Mini IPG at least once a day This communication occurs whenever the 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 alert screen displayed by the Vesta Charger In this ca...

Страница 61: ...let This will ensure regular communications between the OPTIMIZER Smart Mini IPG and the Vesta Charger Remain stationary during the charging or data transfer process Decrease the distance between the devices Move the devices so they share line of sight Move the devices away from other devices that may be causing interference Do not operate other wireless devices i e programmers for other devices l...

Страница 62: ......

Страница 63: ...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 ...

Страница 64: ...Medications OPTIMIZER Smart Mini Implantable Pulse Generator Model No Serial No Lead 1 Model No S N Lead 2 Model No S N Lead 3 Model No S N ...

Страница 65: ...NOTES ...

Страница 66: ......

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