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Part No.: 13-250-004-EU Rev. 02

OPTIMIZER™ Smart Mini

System

* * *

For the Treatment of

Moderate to Severe Heart Failure

Patient’s Manual

Содержание OPTIMIZER Smart Mini

Страница 1: ...Part No 13 250 004 EU Rev 02 OPTIMIZER Smart Mini System For the Treatment of Moderate to Severe Heart Failure Patient s Manual ...

Страница 2: ...se Dynamics The information in this document can be changed 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...

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: ...ONS 32 APPENDIX I 34 Statement of FCC Compliance Error Bookmark not defined FCC Compliance of the Vesta ChargerError Bookmark not defined FCC Compliance of the OPTIMIZER Smart Mini IPG Error Bookmark not defined Electromagnetic Immunity 34 Electromagnetic Immunity of the Vesta Charger 34 Electromagnetic Immunity of the OPTIMIZER Smart Mini IPG 37 Electromagnetic Emissions 42 Electromagnetic Emissi...

Страница 5: ...hat resulted in any of the following i Life threatening illness or injury ii Permanent impairment of a body structure or a body function iii Hospitalization or prolongation of patient hospitalization iv Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function v Chronic disease c A serious public health threat A publ...

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Страница 7: ...ymptoms associated with the inability of the heart muscle to pump enough blood to meet the needs of the body The symptoms of heart failure include difficulty breathing swelling edema of the legs and or arms fatigue poor exercise tolerance mental confusion Many medications of differing actions are currently available for the treatment of heart failure Despite this growing list some patients fail to...

Страница 8: ...od is pumped out by the heart with every heartbeat The OPTIMIZER Smart Mini IPG is powered by a rechargeable battery to extend its service life A charger specifically designed to recharge the battery of the 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...

Страница 9: ...hargeable 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 Figure 2 Vesta Charger ...

Страница 10: ... to 5 Post procedural pain bruising and discomfort at insertion site Bleeding Infection at site of insertion Pocket hematoma Migration of leads Migration of implanted IPG Uncommon between 1 5 Chest trauma such as a collapsed lung or bleeding into the chest Generator complication Cardiac perforation puncture of the heart caused by the leads Endocarditis infection of the heart valves Arrhythmia irre...

Страница 11: ...ber The OPTIMIZER Smart Mini IPG uses its leads to detect the electrical activity of your heart Complications that can affect the lead s ability to perform this function may occur These include A lead may become dislodged from where it was placed during implantation necessitating re operation A lead may fracture or break producing a poor electrical connection necessitating re operation The lead pr...

Страница 12: ...ns Be sure to take all medications as directed by your doctor Do not wear tight clothing that could irritate the skin over the device Avoid 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 a...

Страница 13: ...nding over or other normal daily activities 5 3 Medications Prescription medications taken as directed have no effect upon the 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 r...

Страница 14: ... to be placed at risk by such an event Always seek medical advice before entering an area posted with a warning for pacemaker patients or other medical implantable devices or where 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 Surger...

Страница 15: ...tion surgery your doctor will provide you with an Implanted Medical Device Identification Card indicating 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 ...

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: ...l 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: ...ing 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 to ...

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: ...ry 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 Figure ...

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: ...y 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 Direct Action Alert an alert screen such as the one shown in F...

Страница 35: ...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 A9 A19 A21 A23 A25 or A27 is displayed please c...

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: ...lectrostatic discharge as defined in IEC 61000 4 2 Contact Discharge 8 kV Air Discharge 2 kV 4 kV 8 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 ...

Страница 41: ... ISM and amateur radio bands between 0 15 MHz and 80 MHz 6 V r m s in ISM and amateur radio bands 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 ...

Страница 42: ...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 43: ...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 44: ...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 45: ...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 46: ...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 47: ...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 48: ...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 49: ...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 50: ...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 51: ...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 52: ...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 53: ...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 54: ...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 55: ...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 56: ...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 57: ... 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 58: ...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 59: ...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 60: ......

Страница 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 ...

Страница 62: ...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 63: ...NOTES ...

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