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Intelio Programmer System and Vesta Charger System INSTRUCTIONS FOR USE Part No.: 13-290-012-XX Rev. 01 Impulse Dynamics (USA) Inc. Suite 100 50 Lake Center Executive Parkway 401 Route 73 N Bldg. 50 Marlton, NJ 08053-3425 Impulse Dynamics Germany GmbH MAC Main Airport Center Untershweinstiege 2-14 60549 Frankfurt am Main Germany OPTIMIZER and CCM are trademarks of Impulse Dynamics. OPTIMIZER is a US registered trademark property of Impulse Dynamics The Intelio Programmer and Vesta Charger conform to the essential requirements of the Radio Equipment Directive (RED) 2014/53/EU. The information provided in this document may change without prior notice. No part of this manual may be reproduced or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from 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 Please read the complete documentation provided before you use the device. Revision 0, Date of Issue: 2021-01-22 1.6 1.7 1.8 TABLE OF CONTENTS EXPLANATION OF SYMBOLS ON LABELS .......................................................................................... I THE INTELIO PROGRAMMER SYSTEM ................................................................................... 1 1.0 Description ..................................................................................................................... 1 1.1 Programmer Functions ................................................................................................... 2 1.2 Programmer Components .............................................................................................. 2 1.3 Interconnecting the Programmer Components for Operation ........................................... 2 1.4 Intelio Programming Wand ............................................................................................. 3 1.5 1.5.1 Short-range Communication .............................................................................. 3 1.5.2 Long-range Communication ............................................................................... 3 Legacy Programming Wand ........................................................................................... 3 1.6.1 Legacy Programming Wand Buttons .................................................................. 3 1.6.2 Legacy Programming Wand Indicator Lights ...................................................... 3 Charging the Battery of the Intelio Programmer Tablet PC .............................................. 3 Buttons and Symbols on the Intelio Programmer Tablet PC ............................................ 4 Indicator Lights .................................................................................................. 4 1.8.1 1.8.2 Buttons .............................................................................................................. 4 1.9 Operating the Intelio Programmer ................................................................................... 4 1.10 Using the Intelio Programmer Tablet PC Touch Screen .................................................. 4 1.11 Using the Programming Wands ...................................................................................... 5 1.11.1 Intelio Programming Wand ................................................................................. 5 1.11.2 Legacy Programming Wand ............................................................................... 5 1.12 Routine Cleaning ............................................................................................................ 5 1.13 Maintenance .................................................................................................................. 5 Storage and Handling ..................................................................................................... 5 1.14 INTELIO PROGRAMMER SYSTEM SOFTWARE APPLICATIONS ........................................... 6 Selector Screen .............................................................................................................. 6 2.1 Basic Operation of the OPTIMIZER Smart Mini Programmer Application ........................ 6 2.2 2.2.1 Communication with the OPTIMIZER Smart Mini IPG ........................................ 6 Interrogation and Programming .......................................................................... 6 2.2.2 2.2.3 Monitoring Tools ................................................................................................ 7 2.2.4 Closing the Programmer Application .................................................................. 7 OPTIMIZER SMART MINI PROGRAMMER SOFTWARE ........................................................... 8 Overview of the OPTIMIZER Smart Mini Programmer Application................................... 8 3.1 3.1.1 ECG/IEGM/Marker Pane .................................................................................... 8 3.1.2 Legend for ECG/IEGM/Marker Pane ................................................................ 10 3.1.3 OPTIlink Session Pane .................................................................................... 11 3.1.4 CCM Status Pane ............................................................................................ 12 3.1.5 Programming Buttons Pane ............................................................................. 12 2.0 3.0 i 3.7 3.4 3.3 3.2 3.5 3.6 3.1.6 Mode Bar ......................................................................................................... 13 3.1.7 Status Bar ........................................................................................................ 24 Linking and Interrogation............................................................................................... 25 Initiating a Link with the OPTIMIZER Smart Mini IPG ........................................ 25 3.2.1 Interrogating the OPTIMIZER Smart Mini IPG ................................................... 25 3.2.2 Modifying Parameter Values ......................................................................................... 25 3.3.1 Parameter Color Convention ............................................................................ 26 3.3.2 Parameter Conflicts and Warnings ................................................................... 27 Programming ................................................................................................................ 28 3.4.1 Programming the OPTIMIZER Smart Mini IPG ................................................. 28 3.4.2 Cancel and Undo Functions ............................................................................. 28 Device and CCM Therapy Modes ................................................................................. 29 OVO-LS-CCM Mode ..................................................................................................... 30 3.6.1 ECG/IEGM/Marker Pane in OVO-LS-CCM Mode .............................................. 30 3.6.2 Disabled or Limited Parameters in OVO-LS-CCM Mode ................................... 30 CCM Schedule ............................................................................................................. 31 3.7.1 CCM Therapy Hours/Day ................................................................................. 31 3.7.2 Start Time and End Time .................................................................................. 31 3.7.3 Extend on Low CCM% ..................................................................................... 32 Magnet Mode................................................................................................................ 33 3.8 OPTIset ........................................................................................................................ 33 3.9 Sensing ........................................................................................................................ 38 3.10 3.11 CCM Timing.................................................................................................................. 38 3.12 CCM Train .................................................................................................................... 40 3.13 CCM-ICD Interaction Testing ........................................................................................ 41 3.14 Continuous Mode.......................................................................................................... 41 3.15 Measuring Lead Impedances ........................................................................................ 42 3.16 Resetting the OPTIMIZER Smart Mini IPG .................................................................... 42 3.17 Data Storage ................................................................................................................ 43 Statistics ....................................................................................................................... 44 3.18 3.18.1 Viewing Device Statistics .................................................................................. 44 3.18.2 Resetting Device Counters ............................................................................... 46 Blinded Mode................................................................................................................ 46 Temperature Charge Constants .................................................................................... 47 Patient Alerts ................................................................................................................ 48 3.21.1 Alert Delivery Mode .......................................................................................... 48 3.21.2 Maximum Lead Impedance Change Alert ......................................................... 49 3.21.3 Minimum Target CCM Therapy Rate Alert ........................................................ 49 3.21.4 Battery Recharge Reminder Alert ..................................................................... 50 3.19 3.20 3.21 ii 4.0 3.24 3.21.5 CCM Therapy Suspended Alert........................................................................ 50 3.21.6 Long Time Without Communication With The IPG Alert .................................... 51 3.21.7 Down Mode Alert ............................................................................................. 51 3.21.8 CCM Not Sensing/Noise Alert .......................................................................... 52 3.21.9 Charger Battery Low Alert ................................................................................ 52 3.21.10 Charger Failure Alert........................................................................................ 52 3.21.11 Rechargeable Battery Low Alert ....................................................................... 53 Activity Sensor ............................................................................................................. 53 3.22 3.23 Clock Settings for the OPTIMIZER Smart Mini IPG ....................................................... 54 3.23.1 Reading the OPTIMIZER Smart Mini IPG Time ................................................ 54 3.23.2 Setting the OPTIMIZER Smart Mini IPG Real Time Clock ................................ 54 Standards .................................................................................................................... 55 3.24.1 Saving a Standard File ..................................................................................... 55 3.24.2 Opening a Standard File .................................................................................. 55 3.25 Programmer Log .......................................................................................................... 55 THE VESTA CHARGER SYSTEM............................................................................................ 56 Description ................................................................................................................... 56 4.1 Charging Method .......................................................................................................... 56 4.2 System Components .................................................................................................... 57 4.3 Features ....................................................................................................................... 57 4.4 Overview of the Screens Displayed by the Vesta Charger ............................................ 58 4.5 4.5.1 Screens Displayed When Connected to the AC Adapter .................................. 58 4.5.2 Screens Displayed When Paring with the OPTIMIZER Smart Mini IPG............. 59 4.5.3 Screens Displayed When Charging the OPTIMIZER Smart Mini IPG................ 60 4.5.4 Screens Displayed After the Detection of an Alert Condition ............................. 63 4.5.5 Info Screens .................................................................................................... 65 Pairing the Vesta Charger with the OPTIMIZER Smart Mini IPG ................................... 66 Charging the Vesta Charger ......................................................................................... 67 Charging the OPTIMIZER Smart Mini IPG .................................................................... 68 4.8.1 Early Termination of Charging Session ............................................................ 70 Vesta Charger Placement When Not Being Used for Device Charging.......................... 70 4.9 4.10 Frequency of Charging Sessions .................................................................................. 70 4.11 Communications .......................................................................................................... 71 4.11.1 Communications with the OPTIMIZER Smart Mini IPG ..................................... 71 4.12 Call Doctor Alert Codes ................................................................................................ 71 4.12.1 Call Doctor Alert Code Attributes ...................................................................... 72 4.12.2 Call Doctor Alert Code Definitions .................................................................... 72 4.13 Cleaning ....................................................................................................................... 73 4.14 Maintenance ................................................................................................................ 73 4.6 4.7 4.8 iii 4.15 Storage and Handling ................................................................................................... 73 4.16 Disposal ....................................................................................................................... 74 APPENDIX I .......................................................................................................................................... 75 Statement of FCC Compliance .................................................................................................. 75 FCC Compliance of Intelio Programmer with Intelio Programming Wand ....................... 75 FCC Compliance of Intelio Programmer with Legacy Programming WandError! Bookmark not defined. FCC Compliance of Vesta Charger ............................................................................... 75 Electromagnetic Immunity ......................................................................................................... 77 Electromagnetic Immunity of the Intelio Programmer ..................................................... 77 Electromagnetic Immunity of the Vesta Charger ............................................................ 79 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Intelio Programmer or Vesta Charger ................................. 81 Electromagnetic Emissions ........................................................................................................ 82 Electromagnetic Emissions from the Intelio Programmer with Intelio Programming Wand82 Electromagnetic Emissions from the Intelio Programmer with Legacy Programming Wand86 Electromagnetic Emissions from the Vesta Charger ...................................................... 89 APPENDIX II ......................................................................................................................................... 93 Wireless Technology ................................................................................................................. 93 Intelio Programmer with Intelio Programming Wand Wireless Nominal Specifications .... 93 Intelio Programmer with Legacy Wand Wireless Nominal Specifications ........................ 94 Vesta Charger Wireless Nominal Specifications ............................................................ 94 Quality of Service (QoS) for Wireless Technology ......................................................... 95 Wireless Security Measures .......................................................................................... 96 Troubleshooting for Wireless Coexistence Issues.......................................................... 97 APPENDIX III ........................................................................................................................................ 98 Security of the Intelio Programmer Unit ..................................................................................... 98 How the Programmer Promotes Security ...................................................................... 98 What Hospitals and Clinics Can Do To Promote the Security of Programmers .............. 98 APPENDIX IV ........................................................................................................................................ 99 Procedure for IPG-ICD Interaction Testing: ................................................................................ 99 iv EXPLANATION OF SYMBOLS ON LABELS Symbol Description 0344 CE Conformity marking, 0344 - Notified Body Number Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Consult instructions for use Do not use if package is damaged Storage and transport temperature limits Authorized representative in the European Community Date of manufacture Manufacturer Catalogue number Serial number Refer to instruction manual/booklet Caution, consult instructions for use Item not to be disposed via the municipal waste collection system of any member state of the European Union Class II equipment Type BF applied part Defibrillation-proof type CF applied part i Symbol Description IP22 Non-ionizing electromagnetic radiation Protected against the ingress of solid foreign objects greater than 12.5 mm
(0.5 in) in width;
Protected against the ingress of vertically falling water drops when the enclosure is tilted at an angle of 15 from its normal position Legacy Programming Wand Power Indicator Legacy Programming Wand Interrogation Legacy Programming Wand Programming ii 1.0 THE INTELIO PROGRAMMER SYSTEM 1.1 Description The Intelio Programmer System allows the physician to interrogate and program the OPTIMIZER Smart Mini IPG. The programmer software runs on a touch screen tablet PC with an attached Intelio Programming Interface. Communication between the Programming Interface and the OPTIMIZER Smart Mini IPG is accomplished using the Intelio Programming Wand. The Intelio Programming Wand first uses short-range communications to establish a link with the OPTIMIZER Smart Mini IPG and then long-range RF communications for all subsequent exchanges of information. Understanding the instructions contained in this manual on how to operate the Intelio Programmer System is essential to the proper operation of the OPTIMIZER Smart Mini IPG. The Intelio Programming Interface is classified as Class II equipment. The Programming Wand Port is classified as a Type BF applied part and the ECG Port is classified as a defibrillation-proof Type CF applied part. The Intelio and Legacy Programming Wands are classified as Class II equipment and a Type BF applied part. Warning: The Intelio Programmer System may be subject to interference from other electrical devices operated in the vicinity. Portable and mobile RF equipment are especially likely to impair the normal function of the programmer. If the Intelio Programmer is not operating as expected, such interference has to be always taken into account. Other equipment can also interfere with the Intelio Programmer. Figure 1: Intelio Programmer System 1 1.2 Programmer Functions The functions performed by the Intelio Programmer include the following:
Read (interrogate) OPTIMIZER Smart Mini IPG parameters as currently programmed Modify and program OPTIMIZER Smart Mini IPG parameters Display the patients ECG and IEGM and display markers for analysis Retrieve statistics accumulated by the OPTIMIZER Smart Mini IPG as it operates Log the activity of the OPTIMIZER Smart Mini IPG Store standard programs for future use Monitor activity level of patient Enable Patient Alerts to be displayed by Vesta Charger 1.3 Programmer Components The Intelio Programmer System consists of:
Intelio Programmer Intelio Programmer Tablet PC installed with Optimizer SM Software o o Intelio Programming Interface Intelio Programming Wand Legacy Programming Wand Single-lead (3-wire) ECG cable Charger Bootstrap Cable Medical-grade Power Supply CE marked Power Cord Warning: Use of items other than those identified above or in a manner not in accord with these instructions may cause damage to the Intelio Programmer. 1.4 Interconnecting the Programmer Components for Operation To begin using the Intelio Programmer System with the OPTIMIZER Smart Mini IPG, connect the following components:
Plug the LEMO connector of the Intelio Programming Wand into the gray-ringed port on the right side of the Intelio Programming Interface. Plug the LEMO connector of the ECG cable into the blue-ringed port on the left side of the Intelio Programming Interface. Warning: Do not attempt to directly connect any line-powered device (e.g., using a USB cable to connect to a printer) to the Intelio Programmer. This may create an electrical safety hazard for the patient. 2 1.5 Intelio Programming Wand The Intelio Programming Wand has a 3 m 0.05 m (10 ft 2 in) long cable and is used to communicate with the OPTIMIZER Smart Mini IPG. 1.5.1 Short-range Communication Short-range communication is used when the Intelio Programming Wand is first establishing a link between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. This communication includes the exchange of an encryption key. Frequency: 13.56 MHz 100 ppm Distance: 5 to 40 mm (with the bottom of the wand placed directly over the IPG) 1.5.2 Long-range Communication Long-range communication is used after the Intelio Programming Wand has established a link between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. This communication involves the transfer of encrypted data. Frequency: 402 MHz to 405 MHz (MedRadio) Distance: 0 to at least 1.5 m (5 ft) 1.6 Legacy Programming Wand The Legacy Programming Wand has a 3 m 0.05 m (10 ft 2 in) long cable and is used to communicate with the OPTIMIZER Smart and OPTIMIZER IVs IPG (when the Intelio Programmer is loaded with the device-specific programmer applications). 1.6.1 Legacy Programming Wand Buttons The Legacy Programming Wand has two buttons:
Interrogate Program 1.6.2 Legacy Programming Wand Indicator Lights The Programming Wand also has two different sets of indicator lights:
The Power indicator light, located to the left of the power symbol, is illuminated when the Programming Wand is powered. The bar graph indicator lights display the strength of the telemetry signal between the Programming Wand and the OPTIMIZER Smart IPG. 1.7 Charging the Battery of the Intelio Programmer Tablet PC Warning: Only charge the Intelio Programmer tablet PC battery with the medical-grade power supply provided with the Intelio Programmer System. Do not attempt to recharge the tablet PCs battery with any other power supply. Note: The power cord used with medical-grade power supply must be CE marked. To charge the battery of the Intelio Programmer Tablet PC, perform the following steps:
1. Flip open the protective cover of the power input connector on the Tablet PC (located at 2. Plug the DC output connector of the medical-grade power supply into the power input the bottom left of the Tablet PC). connector on the Tablet PC. 3. Plug one end of the CE marked power cord into the AC input connector of the medical-
grade power supply and then plug the other end into a hospital-grade mains power receptacle. Be sure that the mains voltage is in the range 100 to 240 VAC, 50/60 Hz and that the receptacle has a properly grounded connection. 3 1.8 Buttons and Symbols on the Intelio Programmer Tablet PC The Intelio Programmer tablet PC has three illuminated indicator lights and six buttons located on the right side of the tablet PC. They have the following functions (from top to bottom) 1.8.1 Indicator Lights Power illuminated when the tablet PC is powered ON Battery Charging Status:
o Not illuminated tablet PC is operating on battery power o Illuminated has two color states:
Amber when the battery of the tablet PC is being charged Green when the battery of the tablet PC is fully charged WLAN / WI-FI illuminated when the WI-FI is enabled 1.8.2 Buttons P1: non-functional P2: non-functional Windows: non-functional Volume +: non-functional Volume -: non-functional Power (green): used to power up and shut off tablet PC 1.9 Operating the Intelio Programmer Warning: The Intelio Programmer shall not be used onboard aircraft without the prior consent of its crew. The Intelio Programmer is configured to operate using either mains power from its medical grade power supply or battery power from the Intelio Programmer tablet PCs battery. Note: If the Intelio Programmer is to be used on battery power, fully charge its battery before using it during an implant procedure. To power up the Intelio Programmer Tablet PC, perform the following steps:
1. Connect the Intelio Programming Wand LEMO-type connector into the gray-ringed port on the right side of the Intelio Programmer Interface. 2. Press the Power button on the right side of the tablet PC, hold the button down for 2 seconds, and then release it. has been turned ON. 3. Verify that the Power indicator light is illuminated blue, indicating the Intelio Programmer When the Intelio Programmer has completed booting up, the Selector screen will be displayed on the tablet PC screen. 1.10 Using the Intelio Programmer Tablet PC Touch Screen The Intelio Programmer tablet PC is equipped with a touch screen. Selections on the screen may be made by touching the screen with ones finger or the attached stylus. Warning: DO NOT use sharp items or regular writing equipment (pen, pencil) on the touch screen of the tablet PC. Damage to the touch screen may result. 4 1.11 Using the Programming Wands Caution: Due to the risk of cross-contamination, placement of a Programming Wand directly onto the patients skin should be avoided. 1.11.1 Intelio Programming Wand The Intelio Programming Wand must be kept directly over the patients implant site while it is being used to establish a link between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. Once the link with the OPTIMIZER Smart Mini IPG has been established, the Intelio Programming Wand may be placed at least 1.5 m (5 ft) away from the IPG. 1.11.2 Legacy Programming Wand The Legacy Programming Wand must be kept directly over the patients implant site while in use. 1.12 Routine Cleaning Warning: DO NOT attempt to sterilize the Intelio Programmer or the Programming Wands because any such attempt could severely damage the equipment. Warning: DO NOT submerge any part of the Intelio Programmer in water. Damage to the unit may result. The Intelio Programmer System is not protected against the ingress of water or humidity (ingress protection rating IPX0). Warning: Always turn the Intelio Programmer off prior to cleaning. Following each use, it is recommended that disinfecting wipes be used to clean the exterior of the Intelio Programmer, the ECG cables, and particularly the Programming Wands. Do not use solvents or cleaning cloths impregnated with chemical cleaning agents. 1.13 Maintenance The Intelio Programmer System does not contain any user-serviceable parts. It must be replaced if it fails to operate in accordance with its specifications. The Intelio Programmer tablet PC is powered by a battery that may need to be replaced if the battery fails to adequately maintain a charge or is unable to be fully charged. Contact your local Impulse Dynamics representative if a replacement battery is needed. Warning: Proper disposal of the used battery is essential. Dispose of the used battery in accordance with local environmental requirements. Warning: Never puncture or incinerate a used battery. 1.14 Storage and Handling The Intelio Programmer and Programming Wands are designed maintain functionality after they have been exposed to the following environmental extremes:
Ambient Temperature:-20C to +70C (-4F to 158F) Relative Humidity: 10% to 100% (with or without condensation) Atmospheric Pressure: 500 hPa to 1560 hPa (14.81 inHg to 46.20 inHg) Recommended environmental conditions for normal use are the following:
Ambient Temperature: 0C to +55C (32F to +131F) Relative Humidity: 20% to 75%
Atmospheric Pressure: 700 hPa to 1060 hPa (20.73 inHg to 31.39 inHg) 5 2.0 INTELIO PROGRAMMER SYSTEM SOFTWARE APPLICATIONS The Intelio Programmer System contains software applications that are used to read and modify the parameters that control the OPTIMIZER Smart Mini IPG. 2.1 Selector Screen When the Intelio Programmer is turned ON, the following buttons are displayed on the Selector Screen upon completion of the start-up sequence. Optimizer SM: This button opens the OPTIMIZER Smart Mini Programmer application. System Admin: This selection is password-protected and allows the user to access the operating system of the Intelio Programmer. It is to be used by Impulse Dynamics technical staff only and is not needed for regular clinical use. Shutdown: Selecting the red Shutdown button on the Selector screen shuts off the 2.2 Basic Operation of the OPTIMIZER Smart Mini Programmer Intelio Programmer. Application After the Optimizer SM button has been selected from the Selector screen, the OPTIMIZER Smart Mini Programmer application is displayed on the Intelio Programmer. This application can be used to establish a communications link, interrogate, and program the OPTIMIZER Smart Mini IPG. 2.2.1 Communication with the OPTIMIZER Smart Mini IPG Before the physician can use the Intelio Programmer to program the OPTIMIZER Smart Mini IPG, a communication link must first be established between the Intelio Programmer and the patients device. This is accomplished by means of the Intelio Programming Wand, which must be placed over the patients implant site. Caution: The Intelio Programming Wand must be thoroughly cleaned between uses, and draped when necessary, to prevent patient skin irritation or contamination. Once the Intelio Programming Wand is over the patients implant site, the communication link is established by initiating the Start OPTIlink command. Once this communication link is established, the physician may proceed to perform the various commands available in the OPTIMIZER Smart Mini Programmer application. 2.2.2 Interrogation and Programming The OPTIMIZER Smart Mini IPG has a set of parameters that control its operation. The values of these parameters are referred to as the device (parameter) values. The OPTIMIZER Smart Mini Programmer application can read the device values by means of the Interrogate command. This action is carried out automatically when a communication link has been established between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. Thereafter, the Interrogate command can be issued again, if desired, to update the current status of the OPTIMIZER Smart Mini IPG (e.g., battery voltage, statistics). Whenever the Interrogate command is issued, the currently programmed device values are loaded and displayed on the screen of the OPTIMIZER Smart Mini Programmer application. The values displayed on the screen of the OPTIMIZER Smart Mini Programmer application are referred to as the parameter values. The physician can review and modify the parameter values using the OPTIMIZER Smart Mini Programmer application. The modified parameter values can then be transmitted to the OPTIMIZER Smart Mini IPG by means of the Program command. 6 Note: The modified parameter values displayed on the programmer screen in blue are NOT transferred to the IPG until the Program command is performed. If the new parameter values do not yield the desired clinical effect, they can be canceled using the Undo command. This command resets the device parameters to the previously programmed values. Useful parameter combinations can be stored as standard files (these are also, sometimes, called user presets). The file extension for a standard file is .mips. After the creation of a particular standard, the standard can be loaded for patients who require a similar set of programmed values. The Load Program and Save Program commands of the OPTIMIZER Smart Mini Programmer application read and write data from and to standard (.mips) files. As such, the OPTIMIZER Smart Mini Programmer application can also be used as an editor of standards (see Section 3.20). 2.2.3 Monitoring Tools The Intelio Programmer System offers a Programming Interface with a built-in electrocardiography channel. The patients ECG is displayed in the upper portion of the ECG/IEGM/Marker pane on the OPTIMIZER Smart Mini Programmer application screen. Warning: The displayed ECG is of monitoring quality and is not diagnostic quality. Do not base clinical diagnostic decisions on the displayed ECG. In particular, it is important to note that the chart gradient is not the typical 25 or 50 mm/sec. When the CCM Therapy Mode of OPTIMIZER Smart Mini IPG is not set to OOO mode
(Standby mode), the Intracardiac Electrogram (IEGM) and Event Markers is automatically enabled. Markers are flags that represent the various states of the device and events detected during its operation. In this mode, all events detected and generated by the OPTIMIZER Smart Mini IPG are displayed in the ECG/IEGM/Marker Pane synchronized with the patients ECG. The OPTIMIZER Smart Mini IPG keeps a record of all the events and conditions that have occurred. These records can be downloaded from the OPTIMIZER Smart Mini IPG to the Intelio Programmer, and the number of occurrences of each event can be viewed on the CCM Statistics window of the OPTIMIZER Smart Mini Programmer application (see Section 3.9). The OPTIMIZER Smart Mini Programmer application can be used to measure the impedance of the ventricular leads (see Section 3.13). The OPTIMIZER Smart Mini Programmer application keeps a log of all the interactions that take place with the OPTIMIZER Smart Mini IPG (see Section 3.21). 2.2.4 Closing the Programmer Application Clicking the Exit button in the bottom right corner of the OPTIMIZER Smart Mini Programmer application screen will close the application. When the confirmatory pop window appears, click Close to return the Intelio Programmer to the Selector screen. 7 3.0 OPTIMIZER SMART MINI PROGRAMMER SOFTWARE The OPTIMIZER Smart Mini Programmer Software is an application that is used to read and modify the parameters that control the OPTIMIZER Smart Mini IPG. This section describes the various features of the OPTIMIZER Smart Mini Programmer application. 3.1 Overview of the OPTIMIZER Smart Mini Programmer Application When the OPTIMIZER Smart Mini Programmer Software is started, the OPTIMIZER Smart Mini Programmer application displays the main screen, which includes the following:
ECG/IEGM/Marker Pane o ECG Sub Pane o IEGM Sub Pane o Marker Sub Pane CCM Marker Legend OPTIlink Session Pane CCM Status Pane Programming Buttons Pane Mode Bar Requirement Status Bar Figure 2: OPTIMIZER Smart Mini Programmer Application Main Screen 3.1.1 ECG/IEGM/Marker Pane The ECG/IEGM/Marker pane has the following three sub panes. 8 3.1.1.1 Surface ECG Sub Pane Warning: The displayed ECG should not be used for clinical decision making. Medical decisions should only be based on an independent ECG measurement device. The Surface ECG Sub Pane is displayed at the top of the window. It shows the real-time ECG of the patient. It also contains a Marker button (displayed as Stop Marker or Run Marker) that allows the user to stop and start the running marker screen. Figure 3: Surface ECG Sub Pane 3.1.1.2 IEGM Sub Pane The IEGM Sub Pane is displayed below the Surface ECG Sub Pane. When the OPTIMIZER Smart Mini IPG is not in OOO mode, it shows the far-field IEGM tracings obtained from the OPTIMIZER Smart Mini IPG, the markers for each active lead, the different events and conditions that may occur, and the CCM Status. Figure 4: IEGM Sub Pane 3.1.1.3 Marker Sub Pane The Marker Sub Pane is displayed below the IEGM Sub Pane. When the OPTIMIZER Smart Mini IPG is not in OOO mode, it shows the markers for each active lead, the different events and conditions that may occur, and the CCM Status. Figure 5: Marker Sub Pane 3.1.1.4 CCM Real-Time Statistics Area Within the ECG/IEGM/Marker pane is the CCM Real-Time Statistics Area. It displays the following real-time values:
CCM HR: Heart rate in beats per minute (bpm) CCM AV: AV interval in milliseconds (N/A is displayed in OVO-LS-CCM mode) RV-LS: RV-LS interval in milliseconds Figure 6: ECG Statistics Bar 9 The CCM HR, CCM AV, and RV-LS intervals change dynamically, showing the current reading for each value. 3.1.2 Legend for ECG/IEGM/Marker Pane The Legend for ECG/IEGM/Marker pane defines each marker that may appear in the ECG/IEGM/Marker pane. Figure 7: Legend for ECG/IEGM/Marker Pane 3.1.2.1 CCM States In Marker view, the CCM states are displayed as follows:
Yellow: This is displayed when CCM is inhibited due to the following conditions (the specific cause is indicated within the yellow bar):
o Long AV: Sensed AV interval exceeds Long AV limit (ODO-
LS-CCM mode only). o Short AV: Sensed AV interval shorter than Short AV limit
(ODO-LS-CCM mode only). o A Noise: Noise detected on the atrial sense channel (ODO-LS-
CCM mode only). o V Noise: Noise detected on the ventricular sense channel o AT: Atrial rate above the atrial tachycardia rate limit (ODO-LS-
CCM mode only). o VT: Ventricular rate above the ventricular tachycardia rate limit
(OVO-LS-CCM mode only). o LS Out of Alert: Local sense (LS) event detected outside of the LS Alert window. o PVC: Two successive ventricular sensed events without an intervening atrial sensed event (ODO-LS-CCM mode only). o ImpMeas: If an impedance measurement is taken. o Skipped Pulse: A CCM therapy pulse could not be delivered due to exceptional timing conditions internal to the IPG Dark Blue: CCM is inhibited due to previously detected event (if the CCM inhibit cycle parameter is programmed to be greater than 1). 10 3.1.2.2 IEGM Markers Each lead has its own IEGM Marker. 3.1.2.2.1 A Channel Orange: Atrial sensed event Pink: Noise detected on the A channel 3.1.2.2.2 RV Channel 3.1.2.2.3 LS Channel Green: Right Ventricular (RV) sensed event Pink: Noise detected on the RV channel Blue Rectangle: CCM pulse train delivered on the RV channel Note: The width of the blue rectangle represents the duration of the CCM pulse train on the RV channel. Black: Local Sense (LS) event Yellow: LS Alert Window Light Blue: LS Blanking Refractory Periods Blue Rectangle: CCM pulse train delivered on the LS channel Note: The width of the blue rectangle represents the duration of the CCM pulse train on the LS channel. 3.1.2.3 CCM Status The CCM Status is displayed as follows:
Green: CCM is Active and ON Yellow: Magnet is actively being applied to the OPTIMIZER Smart Mini IPG Dark Gray: CCM is suspended Orange: CCM is set to Continuous mode Gray: The battery voltage of the OPTIMIZER Smart Mini IPG is low 3.1.3 OPTIlink Session Pane When a communication link has not been established with the implanted device, the OPTIlink Session Pane displays the following buttons:
Start OPTIlink: Command button that begins the process of establishing a communication link between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. Open Log: Command button that allows the user to open a log file of a previously interrogated OPTIMIZER Smart Mini IPG. When clicked, it displays a window showing the list of log files stored on the Intelio Programmer. Once a log file is selected, click the Select button to open the log file for the selected device. Figure 8: OPTIlink Session Pane (not linked to IPG) 11 Once a link has been established, the appearance of the OPTIlink Session Pane changes and displays the following:
OPTIlink Signal Strength Indicator: Dynamically displays the quality of the link between the Intelio Programming Wand and the OPTIMIZER Smart Mini IPG. Depending to the quality of the link, waves of the Signal Strength Indicator are displayed the following manner:
o Good quality link 3 green signal waves o Medium quality link 2 yellow signal waves o Low quality link 1 red signal wave Device model Device serial number Close OPTIlink: Command button that closes the communication link between the Intelio Programmer and the OPTIMIZER Smart Mini IPG. Figure 9: OPTIlink Session Pane (good quality link to IPG shown) 3.1.4 CCM Status Pane The CCM Status Pane shows the current status of the following parameters:
Device Mode CCM Therapy Mode CCM Therapy Dosage The CCM Status Pane also has a button that allows the user to suspend permanently and unsuspend CCM therapy. When the button is in its default DISABLE CCM state, clicking it permanently suspends CCM therapy and toggles the button to say ENABLE CCM. When the button is in its ENABLE CCM state, clicking it unsuspends CCM therapy and toggles the button back to say DISABLE CCM. Figure 10: CCM Status Pane 3.1.5 Programming Buttons Pane The Programming Buttons Pane contains the following command buttons:
Nominals: Opens up a pop-up window asking the user to confirm reprogramming of the OPTIMIZER Smart Mini IPG with nominal values. If Yes is chosen, then the nominal values will be programmed into the OPTIMIZER Smart Mini IPG. If No is chosen, then the pop-up window closes. Interrogate: Reads the current parameter values of the OPTIMIZER Smart Mini IPG. These values become the parameter values displayed by the OPTIMIZER Smart Mini Programmer application. 12 Cancel: When parameter values have been modified in the Intelio Programmer but not yet programmed into the OPTIMIZER Smart Mini IPG, it allows the user to discard the changes made to the parameter values. If no device was interrogated and data were loaded from a .mips file, the programmer parameters are set to the values defined in the file. Undo: When parameter values are modified and then programmed into the OPTIMIZER Smart Mini IPG, it allows the user to reprogram the OPTIMIZER Smart Mini IPG with the previously programmed values. Program: Transmits the current parameter values of the OPTIMIZER Smart Mini Programmer application to the OPTIMIZER Smart Mini IPG. This button is disabled when parameter modifications result in a parameter conflict. Figure 11: Programming Buttons Pane Note: When a command button appears grayed out on a Programming Buttons Pane, this indicates that the command is not currently available. 3.1.6 Mode Bar The Mode Bar contains the following buttons:
Follow-up Parameters Diagnostics Preferences Tools When selected, each button displays a different mode with its own set of tabs Figure 12: Mode Bar 13 3.1.6.1 Follow-up Mode The Follow-up Mode contains the following tabs, each with its own separate panel:
Summary: displays the following information:
o Implant date o Last Follow-up date o o IPG Battery information Voltage, last discharge, and number of discharge episodes Information of implanted leads Serial number and ventricular lead impedance (if measured) o Current CCM Therapy Rate 24 hour % and total %
Figure 13: Summary Panel Trends: This tab has the following button:
o CCM Statistics: Used to view the statistics downloaded from the OPTIMIZER Smart Mini IPG. Figure 14: Trends Panel 14 CCM Setting: Displays an overview of the CCM setting currently programmed into the OPTIMIZER Smart Mini IPG. This tab also has the OPTIset Wizard button, which allows the user to let the application analyze the patients heart rhythm and recommend the best settings for the lead sensing, CCM timing, and CCM amplitude parameters. Figure 15: CCM Settings Panel 3.1.6.2 Parameters Mode The Parameters Mode contains the following tabs, each with its own separate panel:
CCM Therapy: Contains the following parameters:
o CCM Therapy Mode o Mode o Start Time o End Time o CCM Magnet Mode o Extend on low CCM %
Note: The On Time is set to 01 h : 00 m and cannot be changed. Note: The Off Time is calculated based on the following parameter values:
CCM Therapy Hours/Day Start Time End Time Figure 16: CCM Therapy Panel 15 Sensing: Contains the following parameters:
o Sensitivity o Polarity This tab also has the OPTIset Propose IEGM Sensitivities button, which allows the user to let the application analyze the patients heart rhythm and recommend the best settings for the sensing parameters. CCM Timing: Contains the following parameters categories and their Figure 17: Sensing Panel associated parameters:
o A/V REFRACTORIES Post-V Atrial Refractory Post-V Ventricular (RV) Refractory o CCM INHIBIT CCM Cycle Inhibit AV Limits Short Long Tachycardia o TIMING ALGORITHM LS Channel assignment LS Alert Start LS Alert Width LS Blanking Refractory Pre and Post A Pre and Post RV Post LS 16 This tab also has the OPTIset Propose CCM Algorithm Timing button, which allows the user to let the application analyze the patients heart rhythm and recommend the best settings for the CCM timing parameters. Figure 18: CCM Timing Panel CCM Train: Contains the following parameters:
o CCM Train Delay o CCM Amplitude o Number of Biphasic Pulses o Balancing o First Phase Polarity o Phase Duration o Interval o CCM Channels RV LS This tab includes the CCM Train Graphic Display Window (on the right side of the CCM Train panel) that shows a graphical view of the CCM Train parameters with respect to the LS event. The each parameter displayed in the window dynamically changes whenever its parameter value is modified. This tab also has the OPTIset Propose CCM Amplitude button, which allows the user to let the application analyze the lead impedance of the ventricular leads and recommend the best setting for the CCM amplitude. Figure 19: CCM Train Panel 17 3.1.6.3 Diagnostics Mode The Diagnostics Mode contains the following tabs, each with its own separate panel:
Continuous Mode: This tab has the following buttons:
o Start Continuous Mode o Stop Continuous Mode Figure 20: Continuous Mode Panel Leads: This tab has the following button:
o Measure Lead Impedance Figure 21: Leads Panel Battery: Displays the IPG Battery information voltage, estimated capacity, last discharge, and number of discharge episodes. Figure 22: Battery Mode Panel Special Modes (for expert use only): These buttons are enabled only after the correct passcode has been entered. 18 o Lead Depolarization: Connects V1 and V2 electrode together to dissipate accumulated charge. o IPG Reset: Resets the IPGs microcontrollers and reset and programs all parameter values to their nominal settings. o Rechargeable Battery Disconnect: Disconnects IPG battery from device circuitry. Figure 23: Special Modes Panel Data Storage: Displays the following implant information o Implant Date o V1 Lead Model o V2 Lead Model o A Lead Model SN Serial number of V1 lead SN Serial number of V2 lead SN Serial number of atrial lead o Paced Rhythm (co-implanted CRM device) Indicates whether the Paced Rhythm flag has been enabled. o CCM Delay/CCM Start Limit Measure During OPTIMIZER/ICD Interaction Testing Shows limit (in milliseconds) of this value. o Minimum R-R Interval in ICD VT Zone Shows limit (in milliseconds) of this value. Figure 24: Data Storage Panel 19 3.1.6.4 Preferences Mode The Preferences Mode contains the following tabs, each with its own separate panel:
OPTIhome (future capability) Figure 25: OPTIhome Panel Charger: This tab has the following buttons:
Note: This mode is to be used only for blinded clinical investigation protocols o Set Blind Mode o Clear o Temperature Charge Constants Figure 26: Charger Panel Patient Alerts: This tab has the following parameters:
o Alert Delivery Mode o Maximum Lead Impedance Change o Minimum Target CCM Therapy Rate o Battery Charge Reminder o CCM Therapy Suspended Start End
Days 20 o Long Time Without Communication With The IPG o Long Time Without Transmitting To The Remote Monitor Days Days o Down Mode o CCM Not Sensing/Noise o Charger Battery Low o Charger Failure o Rechargeable Battery Low Figure 27: Patient Alert Panel Activity: This tab has the Activity Sensor Setup button Figure 28: Activity Panel Print/File: This tab has the following buttons:
o Parameter Report: Creates a report (that can be saved in PDF file format) of the current parameters settings programmed into the OPTIMIZER Smart Mini IPG. o Database Backup: Backs up log files stored on the Intelio o Database Restore: Loads backed up log files onto the Intelio Programmer. Programmer. 21 Figure 29: Print/File Panel Clock: This tab has the following buttons:
o Read IPG Clock: Reads the current date and time from the OPTIMIZER Smart Mini IPG. o Set IPG Clock (inactive until Read IPG Clock command is executed): Manual setting of the clock in the OPTIMIZER Smart Mini IPG. o Synchronize IPG Clock To Programmer Clock: Sets the clock in the OPTIMIZER Smart Mini IPG to the current date and time of the Intelio Programmer. Figure 30: Clock Panel 3.1.6.5 Tools Mode The Tools Mode contains the following tabs, each with its own separate panel:
Standards: This tab has the following buttons:
o Load Program: Loads the saved standard file onto the OPTIMIZER Smart Mini Programmer application. o Save Program: Saves the current parameter values as a standard file. 22 Figure 31: Standards Panel Logs: This tab displays the Programmer Log. Figure 32: Logs Panel Engineering (for expert use only): These buttons are enabled only after the correct passcode has been entered. o Update Implantable IPG: Updates the firmware of the OPTIMIZER Smart Mini IPG using firmware loaded from a separate USB flash drive. o Get Device Log: Downloads the activities log from the OPTIMIZER Smart Mini IPG. o Telemet Memory Dump o Therapy Memory Dump Figure 33: Engineering Panel 23 About: This tab displays the following information regarding the firmware or software listed items:
o IPG Telemetry Version: Firmware version of the OPTIMIZER Smart Mini IPGs telemetry module. Therapy Version: Firmware version of the OPTIMIZER Smart Mini IPGs therapy module. ALCP Version o Programmer Application ALCP o Programming Interface Version: Software version of the OPTIMIZER Smart Mini Programmer application. Version: Firmware version of Intelio Programming Wand 3.1.7 Status Bar Figure 34: About Panel The Impulse Dynamics log is displayed at the screens last line along with the laptops battery charge percentage and the following buttons:
Restrictions and Warnings: (becomes active when a parameter conflict, restriction, or warning is present): When clicked, opens the Error Message window, which displays the restriction and/or warning message. When clicked again, closes Error Message window. Exit: When clicked, a pop-up window appears, asking the user to confirm the closure of the Programmer Software. If Close is chosen, the Programmer application will close. If Cancel is chosen, then the pop-up window closes. Figure 35: Status Bar 24 3.2 Linking and Interrogation 3.2.1 Initiating a Link with the OPTIMIZER Smart Mini IPG To initiate a link with the OPTIMIZER Smart Mini IPG:
Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site Click the Start OPTIlink button on the OPTIlink Session Pane The message Place OPTIlink Wand over IPG will first be displayed, followed by the message IPG identified Keep Wand over IPG, and then finally the message OPTIlink downloading IPG data If the link is successful, the OPTIlink Session Pane will display the device model and serial number along with a button Close OPTIlink. In addition, the CCM Status Pane will display the current CCM therapy status. However, if the Intelio Programming Wand is not well-positioned over the implant site, the interrogation operation may fail. If a failure in communication occurs, the OPTIlink Session Pane will display the message Failed to establish OPTIlink session. If this occurs, reposition the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site and click the Start OPTIlink button again. When the Start OPTIlink has been successfully completed, the OPTIMIZER Smart Mini Programmer application automatically performs an interrogation of the OPTIMIZER Smart Mini IPG and reads the latest statistics from the device. Note: Once the link with the OPTIMIZER Smart Mini IPG has been established, the Intelio Programming Wand may be retired from its position directly over the implant site and placed at least 1.5 m (5 ft) away from the IPG. 3.2.2 Interrogating the OPTIMIZER Smart Mini IPG The Interrogation command may be used to update the information about the OPTIMIZER Smart Mini IPG displayed by the OPTIMIZER Smart Mini Programmer application (e.g., IPG battery voltage). To interrogate the OPTIMIZER Smart Mini IPG:
Click the Interrogate button on the Programming Buttons Pane 3.3 Modifying Parameter Values Parameter values can be viewed and modified by selecting the Parameters or Preferences button on the Mode Bar, selecting one of the tabs associated with each mode, and then choosing one of the parameters on the panel. Parameter values are displayed in three different ways:
For parameters that can only be enabled or disabled (except CCM Channels), a sliding toggle switch is used. Sliding the switch right turns the option ON. Sliding the switch left turns the option OFF. For the CCM Channels, checkboxes are used to enable or disable this parameter. To toggle the options for the CCM channels, click the checkbox to the left of each CCM channel. When clicking on a CCM channel checkbox causes it to become filled in, this action enables the channel. When clicking on a CCM channel checkbox causes it to become empty, this action disables the channel. 25 For parameters that have a set of possible values, the parameter value is shown outlined by a small rectangular box. In order to modify its value, select the parameter value shown. A window with all the possible values for the selected parameter will then appear. To modify the value of the parameter, select the new value in the list. When the selection is made, the parameter window automatically closes and the selected parameter value is shown. In addition, the parameter window has a green pin on the top right corner that, when clicked, changes the pin color to red, keeping the window open and preventing the user from making a selection. Clicking the red pin changes its color back to green and allows the user to select a parameter value. To modify a parameter value:
Select the tab where the parameter to be modified appears Select the parameter value to be modified. If the parameter is a switch, then it will change from one state to another (e.g., OFF to ON or vise versa). If the parameter is not a switch, a window with all of its possible values will appear. Select the new value from the list. This value will become the new parameter value. Note: Parameter values displayed on the Programmer screen are not transferred to the IPG until the Program command is issued. Some parameters directly depend on others (such as rates and periods). In such cases, modifying the value of a parameter will automatically modify the value of parameters that directly depend on it. There also are parameters for which values are valid only when some other parameters are enabled or have certain values (for instance, if the device mode of the OPTIMIZER Smart Mini IPG is set to OOO, then no parameters are valid). When the setting of a parameter is meaningless in the context of other parameters, its value is not displayed. 3.3.1 Parameter Color Convention When viewing a set of parameter values in a parameter window, the following color convention is used to represent the different parameter choices:
Black: For the current parameter value programmed into the OPTIMIZER Smart Mini IPG. Blue: For parameter values that are different from the current programmed value which, if selected, will not result in a parameter conflict. Yellow: For parameter values that are different from the current programmed value which, if selected, will result in a parameter warning. Red: For prohibited values which, if selected, will result in a parameter conflict. Note: Not all parameter windows will include all four types of parameter choices. The black/blue/yellow/red (programmed, pending, warning, conflict) color convention is also used when viewing the parameter values displayed on the various panels. Thus the user can identify which parameters are currently programmed into the OPTIMIZER Smart Mini IPG, which parameters have been modified but not yet programmed, and which parameters will generate a parameter conflict or warning. 26 3.3.2 Parameter Conflicts and Warnings 3.3.2.1 Parameter Conflict When a parameter value that is incompatible with other parameter values is selected, a parameter conflict occurs. When such situations arise, an error message is displayed in the Error Message Window. To view the Error Message Window:
Click the Restrictions and Warnings button on the Status Bar The parameter conflict error messages displayed in the Error Message Window include:
Which parameter values are in conflict An explanation of why the conflict arose When a parameter conflict occurs, all the parameter values that are in conflict are displayed in red. As long as there is a parameter conflict, the OPTIMIZER Smart Mini Programmer application will not allow the OPTIMIZER Smart Mini IPG to be programmed with new parameter values. This ensures that only compatible parameter configurations can be downloaded to the OPTIMIZER Smart Mini IPG. To resolve a parameter conflict, new values must be selected for the parameters that are causing the conflict. Resolving the parameter conflict may be rapidly achieved by:
Viewing the list of available values for the parameter(s) in conflict and selecting a new blue parameter value for each parameter setting. Note: It is permissible to select a parameter that causes a conflict provided that the values of the other parameters involved in the conflict are changed to new blue values that resolve the conflict. 3.3.2.2 Parameter Warning When a parameter value that violates a logical condition is selected, a parameter warning occurs. When such situations arise, a warning message is displayed in the Error Message Window. To view the Warning Message Window:
Click the Restrictions and Warnings button on the Status Bar The parameter conflict warning messages displayed in the Error Message Window include:
Which parameter values are violating a logical condition An explanation of the logical condition being violated When a parameter warning occurs, all the parameter values that are violating a logical condition are displayed in yellow. Though there is a logical condition being violated, the OPTIMIZER Smart Mini Programmer application still allows the OPTIMIZER Smart Mini IPG to be programmed with new parameter values. 27 3.4 Programming To resolve a parameter warning, new values must be selected for the parameters that are causing the issue. Resolving the parameter warning may be rapidly achieved by:
Viewing the list of available values for the parameter(s) violating the logical condition and selecting a new blue parameter value for each parameter setting. Note: It is permissible to select a parameter that causes a warning provided that the values of the other parameters involved in the warning are changed to new blue values that resolve the warning. 3.4.1 Programming the OPTIMIZER Smart Mini IPG Programming the OPTIMIZER Smart Mini IPG with the modified parameter values is allowed only if no parameter conflict occurs. The Program button will indicate whether a modified parameter value is allowed in the following manner:
Disabled, if there is a parameter conflict, Blinking amber, if parameter values have been modified, and there is no parameter conflict. To program the modified parameter values:
Click the Program button on the Programming Buttons Pane If the programming is successful, the Program button will change from blinking amber to blue, and the modified parameter values on the OPTIMIZER Smart Mini Programmer application screen will become black, indicating that they are now the programmed parameter values of the OPTIMIZER Smart Mini IPG. 3.4.2 Cancel and Undo Functions Modifications to the parameter values can be reset to the previous values in two different ways. The method used to reset the modified parameters depends on whether or not the modified parameters have been programmed into the OPTIMIZER Smart Mini IPG. 3.4.2.1 Cancel If any parameter values have been modified but not yet programmed into the OPTIMIZER Smart Mini IPG, the Cancel command will reset the parameter values to the last interrogated/programmed set. To cancel modifications:
Click the Cancel button on the Programming Buttons Pane Please note that after executing a Cancel command, the parameter values in the OPTIMIZER Smart Mini Programmer application screens become black, since they are the same as the parameter values in the OPTIMIZER Smart Mini IPG. If no device was interrogated and parameter data were loaded from a .mips file, the displayed parameter values are the values stored in the standard (.mips file). 3.4.2.2 Undo If the OPTIMIZER Smart Mini IPG has been reprogrammed with a new set of parameter values, the Undo button resets the parameter values to the prior set of programmed values. To undo the most recent programming:
Click the Undo button on the Programming Buttons Pane 28 3.5 Device and CCM Therapy Modes The device mode of the OPTIMIZER Smart Mini IPG is set by the Mode parameter. To set the device mode of the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Select the CCM Therapy tab On the CCM Therapy panel, click the Mode parameter The Mode parameter window will display the following options for this parameter:
o OOO: The device is placed in safe mode with no CCM therapy delivery. o ODO-LS-CCM: The device uses atrial, ventricular (RV), and local sense
(LS) events as inputs in determining if CCM therapy should be delivered. o OVO-LS-CCM: The device uses only RV and LS events as inputs in determining if CCM therapy should be delivered. Select one of the parameter choices shown in the Mode parameter window Note: If ODO-LS-CCM or OVO-LS-CCM is selected, the CCM Therapy Mode parameter, Sensing parameters, and CCM Timing parameters become enabled, allowing the user to set these parameters. To set the CCM Therapy Mode parameter:
On the CCM Therapy panel, click the CCM Therapy Mode parameter The CCM Therapy Mode parameter window will display the following options for this parameter:
o OFF Turns OFF the delivery of CCM therapy. o ON Enables the OPTIMIZER Smart Mini IPG to deliver CCM therapy a set number of hours per day within the timeframe set by the Start Time and End Time parameters. The delivery of CCM therapy occurs in one hour intervals with pauses in between each interval for a calculated amount of time based on the hours per day, Start Time, and End Time parameter settings. o OVO-LS-CCM: The device uses only RV and LS events as inputs in determining if CCM therapy should be delivered. Select one of the parameter choices shown in the CCM Therapy Mode parameter window Note: If ON is selected, the CCM Train parameters as well as the remaining CCM Therapy parameters become enabled, allowing the user to set these parameters. Note: If the parameter value ON is red after it is selected, at least one CCM Channel under the CCM Train tab must be enabled before continuing. Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting Note: The Device and CCM Therapy modes can also be set using the CCM Status Pane. 29 3.6 OVO-LS-CCM Mode When the OPTIMIZER Smart Mini IPG is set to OVO-LS-CCM mode, the device no longer detects the presence of atrial events. Accordingly, all markers associated with atrial events are ignored and all parameters associated with atrial events are disabled. In addition, limitations are placed on certain parameters in order to ensure that CCM therapy is delivered appropriately. 3.6.1 ECG/IEGM/Marker Pane in OVO-LS-CCM Mode Since atrial signals and events are ignored in OVO-LS-CCM mode, the atrial IEGM, CCM AV interval, and atrial event markers are not displayed in the ECG/IEGM/Marker Pane. Figure 36: ECG/IEGM/Marker Pane in OVO-LS-CCM Mode 3.6.2 Disabled or Limited Parameters in OVO-LS-CCM Mode Below is a list of parameters that are disabled or limited when the OPTIMIZER Smart Mini IPG is set to OVO-LS-CCM mode:
The Sensitivity and Polarity parameters for the Atrium are disabled The display of PVC, AT, Long AV, and Short AV markers are disabled The minimum V1 and V2 sensitivity setting is limited to 1.0 mV CCM Inhibit on PVC is disabled CCM Inhibit on Long AV is disabled CCM Inhibit on Short AV is disabled CCM Inhibit on Atrial Tachycardia is disabled CCM Inhibit on Ventricular Tachycardia is enabled, with a programmable range, but a maximum of 110 bpm The maximum LS Alert Window Width is limited to 30 ms The maximum CCM Train Delay is limited to 45 ms Figure 37: Sensing Panel in OVO-LS-CCM Mode 30 Figure 38: CCM Timing Panel in OVO-LS-CCM Mode 3.7 CCM Schedule In addition to the device and CCM therapy modes parameters, the CCM Therapy panel also contains the parameters that set the CCM therapy schedule. 3.7.1 CCM Therapy Hours/Day The CCM hs/days parameter sets the total number of hours per day the OPTIMIZER Smart Mini IPG is scheduled to deliver CCM therapy. By default, the CCM hs/days parameter is set to 7 hs/day. To access the CCM hs/days parameters:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Select the CCM Therapy tab On the CCM Therapy panel, click the CCM hs/day parameter Select one of the parameter choices shown in the CCM hs/day parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.7.2 Start Time and End Time The Start Time and End Time parameters set the general start and end time of CCM therapy delivery during each day. By default, the CCM therapy schedule is set to be distributed over a 24 hour period each day. To set the parameters for Start Time and End Time:
On the CCM Therapy panel, select the Start Time Hour parameter Select one of the parameter choices shown in the Start Time Hour (h) parameter window On the CCM Therapy panel, select the Start Time Minute parameter Select one of the parameter choices shown in the Start Time Minute (m) parameter window On the CCM Therapy panel, select the End Time Hour parameter Select one of the parameter choices shown in the End Time Hour (h) parameter window On the CCM Therapy panel, select the End Time Minute parameter 31 Select one of the parameter choices shown in the End Time Minute (m) parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter settings. Below the Start Time and End Time parameters are On Time and Off Time settings. The On Time is the amount of time the OPTIMIZER Smart Mini IPG is scheduled to deliver CCM therapy and is always set to 01 h : 00 m. The Off Time parameter is the amount of time the OPTIMIZER Smart Mini IPG is scheduled to not deliver CCM therapy and is calculated depending on the parameter values set for the CCM hs/days, Start Time, and End Time parameters. Note: When the parameter CCM hs/days is set to a specific value, the OPTIMIZER Smart Mini Programmer application automatically calculates and sets the exact times for the Off Time parameters using the default parameters for the Start Time and End Time. For instance, if the CCM therapy rate is set to 7 hours per day distributed over 24 hours, it sets the following standard scheduling parameters:
CCM Therapy Mode:
ON 7 hs/day Start Time:
On Time:
00 h 01 h 00 m 00 m End Time:
23 h 59 m Off Time:
02 h 25 m 3.7.3 Extend on Low CCM%
The OPTIMIZER Smart Mini Programmer application features the Extend on Low CCM% parameter, which when enabled, allows the OPTIMIZER Smart Mini IPG to extend the On Time period for CCM therapy delivery based on the percentage of CCM therapy delivered during the original 1 hour On Time period. The amount in which the On Time is extended is as follows:
If the CCM% is 80% to 90%, the On Time is extended 11%
If the CCM% is 70% to 79%, the On Time is extended 26%
If the CCM% is 60% to 69%, the On Time is extended 46%
If the CCM% is less than 60%, the On Time is extended 72%
In all cases, the Off Time is correspondingly reduced by the same amount. To enable the Extend on low CCM% feature:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Select the CCM Therapy tab On the CCM Therapy panel, toggle the Extend on Low CCM% button to ON Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 32 3.8 Magnet Mode 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 (23 seconds), sets the OPTIMIZER Smart Mini IPG into Magnet Mode (indicated by a yellow bar in CCM Status row of the Marker Sub Pane), suspending CCM therapy. When the magnet is removed from the implant site, this suspension of CCM therapy is maintained. In this state, the OPTIMIZER Smart Mini IPG still senses and classifies cardiac events. Note: This feature is useful for turning off CCM therapy delivery when an Intelio Programmer is not available (for example, when a STAT ECG needs to be performed on a patient in an Emergency Room not equipped with an Intelio Programmer). To set the parameter associated with this Magnet Mode suspension:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Select the CCM Therapy tab On the CCM Therapy panel, click the CCM Magnet Mode button The Magnet Mode parameter window will display the following options for this parameter:
o Off 1 day: temporarily suspends CCM therapy delivery for 24 hours after the magnet is applied to the OPTIMIZER Smart Mini IPG or until the Program command is sent to the IPG Note: If at any time during this 24 hour period, a pacemaker magnet is reapplied over the implant site of the OPTIMIZER Smart Mini IPG for at least two cardiac cycles (2-3 seconds) and then removed from the implant site, the 24-hour period is restarted. o Off: permanently suspends CCM therapy delivery after the magnet is applied to the OPTIMIZER Smart Mini IPG until the Program command is sent to the IPG Select one of the parameter choices and then click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.9 OPTIset Note: If the parameter Paced Rhythm is set to ON (see Data Storage section), the OPTIset tool cannot be used. The OPTIMIZER Smart Mini Programmer application features the OPTIset tool, which can be used to propose new values for the following parameters:
IEGM Sensitivities CCM Algorithm Timing CCM Amplitude 33 The OPTIset tool is offered collectively as the OPTIset Wizard or as the following individual tools:
OPTIset: Propose IEGM Sensitivities (located on Sensing panel) OPTIset: Propose CCM Algorithm Timing (located on CCM Timing panel) OPTIset: Propose CCM Amplitude (located on CCM Train panel) To use the OPTIset Wizard tool:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Follow-up button on the Mode Bar Select the CCM Setting tab On the CCM Setting panel, click the OPTIset Wizard button The OPTIset window will appear. Note: If the parameter Paced Rhythm is set to ON (as indicated by a filled in checkbox, the buttons on the OPTIset will all be disabled. Note: The CCM Mode used by the OPTIset tool during its analysis can be changed by modifying the CCM Mode parameter on the OPTIset window. The Acquisition Time parameter allows the user to adjust the time allotted the OPTIset to analyze the patients IEGM and determine the best settings for each parameter. If desired, adjust the Acquisition Time o Click the Acquisition Time parameter o When the pull-down menu appears, select the desired Acquisition Time from the list of choices Click the OPTIset: Propose IEGM Sensitivities button Figure 39: OPTIset Window (Initial) 34 When the OPTIset: CCM IEGM SENSITIVITIES window appears, the analysis will begin automatically. If successful, a green checkmark will be shown along with a message indicating that the OPTIset proposal of sensitivities is complete. If any proposed parameter value is different than the current programmed value, it will be shown in blue. Note: The proposed parameter values can be modified by clicking on the specific parameter and choosing a new value. Note: If the OPTIset is not able to successfully find a set of proposed values, click the Repeat button to repeat the analysis. If afterwards the OPTIset is still not able to successfully find a set of proposed values, click the red X at the top right corner of the window to close the OPTIset application and proceed to setting the IEGM Sensitivity parameters manually on the Sensitivity tab. When OPTIset has successfully completed its analysis and displayed its recommended settings for the IEGM sensitivity, the Accept & Continue button will become enabled. Click the Accept & Continue button on the OPTIset: CCM IEGM SENSITIVITIES window. Figure 40: OPTIset: CCM IEGM SENSITIVITIES Window When the OPTIset window appears again, click the OPTIset: Propose CCM Algorithm Timing button When the OPTIset: CCM ALGORITHM TIMING window appears, the analysis will begin automatically. If successful, a green checkmark will be shown along with a message indicating that the OPTIset proposal of CCM algorithm timing is complete. If any proposed parameter value is different than the current programmed value, it will be shown in blue. Note: The proposed parameter values can be modified by clicking on the specific parameter and choosing a new value. Note: If the OPTIset is not able to successfully find a set of proposed values, click the Repeat button to repeat the analysis. If afterwards the OPTIset is still not able to successfully find a set of proposed values, click the red X at the top right corner of the window to close the OPTIset application and proceed to manually set the CCM Timing parameters on the CCM 35 Timing tab. This will also cause any proposed changes to the IEGM Sensitivity parameters to be discarded. When OPTIset has successfully completed its analysis and displayed its recommended settings for the CCM algorithm timing, the Accept & Continue button will become enabled. Click the Accept & Continue button the OPTIset: CCM ALGORITHM TIMING window. Figure 41: OPTIset: CCM ALGORITHM TIMING Window When the OPTIset window appears again, click the OPTIset: Propose CCM Amplitude button When the OPTIset: CCM AMPLITUDE window appears, the analysis will begin automatically if at least one CCM Delivery Channel has been enabled. Note: If no CCM Delivery channels have been enabled, enable one CCM Delivery channel, wait for OPTIset to complete its analysis, and then enable the second CCM Delivery channel. If successful, a green checkmark will be shown along with a message indicating that the OPTIset proposal of CCM algorithm amplitude is complete. If the proposed CCM Amplitude parameter value is different than the current programmed value, it will be shown in blue. Note: The proposed CCM Amplitude parameter value can be modified by clicking on the parameter and choosing a new value. Note: If the OPTIset is not able to successfully find a proposed CCM Amplitude parameter, click the Repeat button to repeat the analysis. If afterwards the OPTIset is still not able to successfully find a proposed CCM Amplitude parameter, click the red X at the top right corner of the window to close the OPTIset application and proceed to manually set the CCM Timing parameters on the CCM Timing tab. This will also cause any proposed changes to the CCM Algorithm Timing and CCM IEGM Sensitivity parameters to be discarded. When OPTIset has successfully completed its analysis and displayed its recommended setting for the CCM algorithm amplitude, the Accept & Continue button will become enabled. 36 Click the Accept & Continue button on the OPTIset: CCM AMPLITUDE window. Figure 42: OPTIset: CCM AMPLITUDE Window When the OPTIset window appears again, click the Accept & Continue button Figure 43: OPTIset Window (Final) 37 When the OPTIMIZER Smart Mini Programmer application returns to its main application screen, click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter settings. 3.10 Sensing The Sensing panel contains the following parameters:
Sensitivity: This parameter is used to determine the sensitivity threshold and set the final sensitivity setting for the lead. After the sensitivity threshold for a lead has been determined, the final sensitivity setting is typically set to the closest parameter value representing 50% of the leads sensitivity threshold value. Polarity: This parameter offers the following options:
o Bipolar: The signal is sensed between lead tip (distal electrode) and ring
(proximal electrode) of a bipolar lead. o Unipolar: The signal is sensed between lead tip (distal electrode) and the case of the OPTIMIZER Smart Mini IPG. To modify the Sensing parameters:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG. o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site. o Click the Start OPTIlink button on the OPTIlink Session Pane. Click the Parameters button on the Mode Bar. Select the Sensing tab. On the Sensing panel, click the Sensitivity parameter for each lead and modify as needed to determine the sensitivity threshold and the final sensitivity setting for the lead. Click the Polarity parameter for each lead and modify as needed. Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting. 3.11 CCM Timing The CCM Timing panel contains the parameters for setting the following parameter categories:
A/V Refractories: Consist of the following set of parameters:
o Post-V Atrial Refractory Period: Sets the time interval after a ventricular (RV) event when signals sensed on the atrial lead are not acknowledged as atrial events. Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-LS-CCM mode. o Post-V Ventricular (RV) Refractory Period: Sets the time interval after a ventricular (RV) event when signals sensed on the RV channel are not acknowledged as ventricular (RV) events. CCM Inhibit: Consist of the following set of parameters that control CCM inhibition:
o CCM Inhibit Cycles: Sets the number of cycles for which CCM therapy delivery will continue to be inhibited after the initial inhibiting event. Note: The number of inhibited cycles applies to the most recent detected event that caused CCM therapy inhibition. If a new inhibiting event is detected during a period of CCM therapy inhibition, this will trigger a new inhibition period. o Short AV Limit: Sets the minimum permissible interval between an atrial and a ventricular event. 38 Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-LS-CCM mode. o Long AV Limit: Sets the maximum permissible interval between an atrial and a ventricular event. Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-LS-CCM mode. o Tachycardia: This parameter is dependent on the CCM Mode of the device. ODO-LS-CCM mode: When operating in this mode, sets the maximum limit for the number of detected atrial events per minute. OVO-LS-CCM mode: When operating in this mode, sets the maximum limit for the number of detected ventricular (RV) events per minute. Timing Algorithm: Consist of the following set of parameters that control events that control CCM timing:
o LS: Assigns the V1 or V2 lead as the LS channel. o LS Alert Start: Sets the start of the time interval during which a valid LS event must be sensed in order to trigger the delivery of CCM therapy. Note: The Alert Window starts inside the AV interval if the parameter value is negative. o LS Alert Width: Sets the time interval duration in which a valid LS event must be sensed in order to trigger the delivery of CCM therapy. Note: If the sum of Alert Start and Alert Width is negative, the Alert Window ends inside the AV interval. Note: When the OPTIMIZER Smart Mini IPG is in OVO-LS-CCM mode, the maximum allowable setting for this parameter is 30 ms. LS Blanking Refractories: Consist of the following set of parameters that allow for the masking of unwelcome signals (e.g., noise) that may be detected before or after an atrial, RV, or LS event:
o Pre A Refractory Period: Sets the time interval before an atrial event when LS signals are masked from detection. Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-
LS-CCM mode. o Post A Refractory Period: Sets the time interval after an atrial event when LS signals are masked from detection. Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-
LS-CCM mode. o Pre RV Refractory Period: Sets the time interval before an RV event when LS signals are masked from detection. o Post RV Refractory Period: Sets the time interval after an RV event when LS signals are masked from detection. o Post LS Refractory Period: Sets the time interval after an LS event when LS signals are masked from detection. To modify the CCM Timing parameters:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane 39 Click the Parameters button on the Mode Bar Select the CCM Timing tab On the CCM Timing panel, modify the CCM Timing parameters as needed Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.12 CCM Train The CCM Train panel contains the following parameters:
CCM Train Delay: Sets the time interval between the leading edge of the Local Sense triggering event and the start of CCM pulse train delivery. Note: When the OPTIMIZER Smart Mini IPG is in OVO-LS-CCM mode, the maximum allowable setting for this parameter is 45 ms. CCM Amplitude: Sets the voltage of the CCM therapy pulse. Number of Biphasic Pulses: Sets the number of biphasic CCM therapy pulses. Balancing: Sets the amount of time used by the OPTIMIZER Smart Mini IPG to discharge any residual polarization at the electrode/tissue interface after the delivery of the CCM pulse train has been completed. First Phase Polarity: Sets the first phase polarity of the CCM therapy pulse and offers the following options:
o Positive: The first phase of the CCM pulse has a positive deflection (e.g., 7.5 V) followed by a corresponding negative deflection (e.g., 7.5 V). o Negative: The first phase of the CCM pulse has a negative deflection followed by a corresponding positive deflection. Phase Duration: Sets the width of each CCM therapy pulse phase. Note: Do not change the Phase Duration from the default setting of 5.13 ms unless directed by a physician. Interval: Sets the time delay between each CCM therapy pulse CCM Channels: Assigns the channel to be used to deliver CCM therapy. To modify the CCM Train parameters:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Select the CCM Train tab On the CCM Train panel, modify the CCM Train parameters as needed Note: The CCM Train Graphic Display Window (on the right side of the CCM Train panel) shows a graphical view of the CCM Train parameters with respect to the LS event. The each parameter displayed in the window dynamically changes whenever its parameter value is modified. Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 40 3.13 CCM-ICD Interaction Testing The OPTIMIZER Smart Mini Programmer application has a CCM-ICD Interaction Testing tool that may be used whenever device/device interaction testing (see Appendix III) is performed between the OPTIMIZER Smart Mini IPG and an implanted ICD. To begin CCM-ICD Interaction Testing:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Parameters button on the Mode Bar Program the Post-V Atrial Refractory Period and Post-V Ventricular (RV) Refractory Period to 389.8 ms (see Section 3.11) Select the CCM Train tab On the CCM Train panel, press and hold the CCM-ICD Interaction Testing button The CCM Train Delay parameter will be temporarily set to 85 ms. To stop the Crosstalk Test:
Release the CCM-ICD Interaction Testing button The CCM Train Delay parameter will be returned to its pre-test programmed value. When testing has been completed, click the Undo button to set the Post-V Atrial Refractory Period and Post-V Ventricular (RV) Refractory Period to their previous programmed values. 3.14 Continuous Mode Continuous Mode allows the user to override scheduled CCM therapy delivery and initiate continuous CCM therapy delivery. Note: The Continuous Mode option is only available when the OPTIMIZER Smart Mini IPG is not in OOO mode and CCM Therapy Mode is set to ON. To start continuous CCM therapy delivery:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Diagnostics button on the Mode Bar Select the Continuous Mode tab On the Continuous Mode panel, click the Start Continuous Mode button The OPTIMIZER Smart Mini IPG will begin delivering continuous CCM therapy delivery for up to one hour. Note: The CCM Status in the Marker Sub Pane will be orange, indicating that CCM therapy is in Continuous Mode. Figure 44: Marker Sub Pane with CCM Therapy in Continuous Mode To stop continuous CCM therapy delivery:
41 If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Diagnostics button on the Mode Bar Select the Continuous Mode tab Click the Stop Continuous Mode button 3.15 Measuring Lead Impedances The OPTIMIZER Smart Mini IPG measures the impedance of the ventricular leads by delivering of a biphasic pulse through each lead with the following parameters:
Number of Biphasic Pulses: 1 Amplitude: 4.5 V Phase Duration: 0.5 ms Interval: 0 ms Balancing: 40 ms The impedance of the ventricular lead can be measured by the OPTIMIZER Smart Mini IPG within the range 75 to 2000, with a tolerance of 20%. Warning: Lead impedance measurements above 1000 are very imprecise and must be construed only as an indication of electrical continuity through the lead. To measure the lead impedances:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Diagnostics button on the Mode Bar Select the Leads tab On the Leads panel, click the Measure Leads Impedance button When completed, the V1 Lead Impedance: and V2 Lead Impedance: fields will become populated with the lead impedance of each ventricular lead. 3.16 Resetting the OPTIMIZER Smart Mini IPG Note: Contact Impulse Dynamics technical support to obtain the passcode prior to attempting to reset the OPTIMIZER Smart Mini IPG. The OPTIMIZER Smart Mini IPG has protective mechanisms that maintain the internal consistency of the system. These mechanisms detect when an internal discrepancy (for instance, clocks not oscillating at the expected frequency) occurs. If in the unlikely event a malfunction of this type occurs, the OPTIMIZER Smart Mini IPG will place itself into a safe state referred to as DOWN Mode. In DOWN Mode, the OPTIMIZER Smart Mini IPG does not deliver CCM therapy and does not sense cardiac events. This status can be changed only by resetting the OPTIMIZER Smart Mini IPG using the OPTIMIZER Smart Mini Programmer application under physician supervision. To reset the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG 42 o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Diagnostic button on the Mode Bar Select the Special Modes tab On the Special Modes panel, click the passcode box, enter the passcode obtained from Impulse Dynamics and then click OK When the Special Modes buttons become enabled, click the Reset button If the OPTIMIZER Smart Mini IPG is successfully reset, the CCM Status Pane will show that the CCM Therapy setting for the OPTIMIZER Smart Mini IPG is OOO, indicating that the device has been set to Standby mode. IMPORTANT: If a device is found to be in DOWN Mode, please document the contents of the DOWN Mode pop-up message, displayed whenever the IPG is interrogated, before resetting the device. After documenting the contents of the DOWN Mode message, contact your Impulse Dynamics representative. Also, please provide details regarding the device mode and the occurrence of any events that may have caused the device to revert to DOWN Mode. 3.17 Data Storage Information pertaining to the implant of the system can be entered and stored in the OPTIMIZER Smart Mini. This information is displayed by the OPTIMIZER Smart Mini Programmer application whenever the Intelio Programmer is used to interrogate the OPTIMIZER Smart Mini. To edit the implant data:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Diagnostic button on the Mode Bar Select the Data Storage tab On the Data Storage panel, click the Edit implant data button When the Data Storage window appears, proceed with setting the implant date and entering the implant data in the fields provided. Figure 45: Data Storage Window 43 When the data entry has been completed, click the Set Implant Data in IPG button The fields on the Data Storage panel should now be populated with the implant information. 3.18 Statistics The OPTIMIZER Smart Mini IPG accrues a statistical record of events and conditions that occur as it functions. This record can be loaded into the OPTIMIZER Smart Mini Programmer application, and appears in the Statistics window of the OPTIMIZER Smart Mini Programmer application, indicating the number of occurrences of each event type. 3.18.1 Viewing Device Statistics To view the Statistics from the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Follow-up button on the Mode Bar Select the Trends tab On the Trends panel, click the CCM Statistics button If successful, the Programmer will display the CCM Statistics table. To view each statistical category, select its CCM Statistics tab. Figure 46: CCM Statistics 3.18.1.1 CCM Statistics Tabs On - General o Events Atrial: The number of atrial events sensed during scheduled CCM delivery Ventricular: The number of ventricular (RV) events sensed during scheduled CCM delivery LS in Alert: The number of local sense (LS) events sensed during scheduled CCM delivery o Periods Normal: The number of normal periods during scheduled CCM delivery Inhibited: The number of inhibited periods during scheduled CCM delivery 44 Post-Inhibited: The number of post-inhibited periods during scheduled CCM delivery o Trains Delivered Total: The total number of CCM trains delivered during scheduled CCM delivery On Inhibition o Causes AT: The number of atrial tachycardia beats detected during scheduled CCM delivery PVC: The number of PVCs detected during scheduled CCM delivery Long AV: The number of times Long AV condition detected during scheduled CCM delivery Short AV: The number of times Short AV condition detected during scheduled CCM delivery LS out of Alert: The number of Local Sense events outside the LS Alert Window during scheduled CCM delivery LS Absence: The number of Local Sense events not detected during scheduled CCM delivery VT: The number of ventricular tachycardia beats detected during scheduled CCM delivery o Noise Episodes A Noise: The number of times atrial noise detected during scheduled CCM delivery V Noise: The number of times ventricular noise detected during scheduled CCM delivery Off General: Displays the same list of statistical counters as detailed under On General (except for Trains Delivered). Statistics for when the OPTIMIZER Smart Mini IPG is scheduled not to deliver CCM therapy Off Inhibition: Displays the same list of statistical counters as detailed under On Inhibition. Statistics for when the OPTIMIZER Smart Mini IPG is scheduled not to deliver CCM therapy Other o Last Session Last Delivery V: The number of ventricular events sensed during the last CCM delivery session Last Delivery Trains: The number of CCM trains delivered during the last CCM delivery session Percentage: CCM delivery percentage during the last CCM delivery session Max Impedance Change Alert: Indicates whether alert was detected during the last CCM delivery session Min Target CCM Therapy % Alert: Indicates whether alert was detected during the last CCM delivery session 45 o General Lead Displacement: The number of lead displacement detections Battery Discharge Episodes: The number of occasions when the device reverted to OOO mode due to the battery voltage dropping below 3.5 V 3.18.1.2 Statistics Buttons Read: Reads statistics from IPG. Reset: Resets statistics stored in IPG. 3.18.2 Resetting Device Counters In order to reset the OPTIMIZER Smart Mini IPG Statistics counters to zero:
To view the Statistics from the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Follow-up button on the Mode Bar Select the Trends tab On the Trends panel, click the CCM Statistics button Select the Reset button at the bottom of the CCM Statistics window As this operation resets the internal counters of the device, a confirmation message will pop up. If the reset request is confirmed, the reset operation is performed. 3.19 Blinded Mode When the OPTIMIZER Smart Mini IPG is used in a blinded clinical investigation, the study protocol may stipulate that one group of patients have their device programmed not to deliver CCM therapy. Since the battery discharge rate of an OPTIMIZER Smart Mini IPG that is NOT delivering CCM therapy is significantly less than a device that is delivering CCM therapy, the potential for the unblinding of the patients device configuration is great. The blinded mode feature allows the charging behavior of an OPTIMIZER Smart Mini IPG not set to deliver CCM therapy to mimic the behavior of an OPTIMIZER Smart Mini IPG that is delivering CCM therapy. To enable Blind Mode and set the minimum charge time:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Charger tab On the Charger panel, click the Set Blind Mode button 46 The Current Status indicator on the Charger panel should change from OFF to ON If required, change the Minimum Charge Time parameter o Click the numerical value from the list of choices o When the pull-down menu appears, select the desired Minimum Charge Time o Click the Set Blind Mode button to program the selected Minimum Charge Time To disable Blind Mode:
Click the Clear button The Current Status indicator on the Charger panel should change from ON to OFF 3.20 Temperature Charge Constants Note: The Temperature Charge Constants do not typically require modification and should only be changed by or at the direction of a physician. In an effort to ensure patient safety while charging the OPTIMIZER Smart Mini IPG, the case temperature of the IPG is monitored during the charging process. The temperature limits used by the OPTIMIZER Smart Mini IPG when monitoring the case temperature are referred to as the Temperature Charge Constants. To read and set the Temperature Charge Constants:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Charger tab Click the Temperature Charge Constants button When the Temperature Charge Constants window appears, click the Read button Click the up/down arrows next to any listed charge constant parameter to change its Click the Set button to program the changes into the OPTIMIZER Smart Mini IPG Click the X at the top right corner of the Temperature Charge Constants window to value close it Figure 47: Temperature Charge Constants Window 47 3.21 Patient Alerts Patient Alerts are specific Direct Action Alerts or Alert Codes displayed by the Vesta Charger that notify the patient of a condition that they need to address. 3.21.1 Alert Delivery Mode The Alert Delivery Mode allows the user to set if and when the OPTIMIZER Smart Mini IPG provides Patient Alerts to the Vesta Charger. To set the Alert Delivery Mode:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, click the Alert Delivery Mode button The Alert Delivery Mode parameter window will display the following options for this parameter:
o Never The delivery of Patient Alerts by the OPTIMIZER Smart Mini IPG to the Vesta Charger is disabled o Always The delivery of Patient Alerts occurs whenever they are detected by the OPTIMIZER Smart Mini IPG o Scheduled The delivery of Patient Alerts only occurs during the period specified by the Alert Delivery Mode Start and End parameter settings Note: If Scheduled is selected, the Start and End parameters become enabled, allowing the user to set these parameters. To set the parameters for Patient Alert Start Time and End Time:
On the Patient Alerts panel, select the Patient Alert Start Time Hour parameter parameter parameter parameter Select one of the parameter choices shown in the Patient Alert Start Time Hour (h) parameter window On the Patient Alerts panel, select the Patient Alert Start Time Minute Select one of the parameter choices shown in the Patient Alert Start Time Minute (m) parameter window On the Patient Alerts panel, select the Patient Alert End Time Hour Select one of the parameter choices shown in the Patient Alert End Time Hour (h) parameter window On the Patient Alerts panel, select the Patient Alert End Time Minute Select one of the parameter choices shown in the Patient Alert End Time Minute (m) parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 48 3.21.2 Maximum Lead Impedance Change Alert The OPTIMIZER Smart Mini IPG is programmed to conduct lead impedance measurements each day automatically. These daily lead impedance measurements are stored and used by the OPTIMIZER Smart Mini IPG to monitor the leads for changes in impedance. The Maximum Lead Impedance Change alert is triggered by the following conditions:
The difference in percentage between the average of the last three daily impedance measurements and the average of the last 30 daily impedance measurements is greater than the maximum lead impedance change %. The last impedance measurement was lower than 50 or greater than 2000. To set the Maximum Lead Impedance Change alert and set its % value:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Maximum Lead Impedance Change button to enable (ON) or disable (OFF) the alert If enabled, the default (or previously programmed) value for the Maximum Lead Impedance Change Percentage parameter will now appear next to Maximum Lead Impedance Change If required, change the Maximum Lead Impedance Change Percentage parameter o Click the numerical parameter value o Select a value from the Maximum Lead Impedance Change Percentage parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.3 Minimum Target CCM Therapy Rate Alert The OPTIMIZER Smart Mini IPG maintains a record of the events and conditions that occurred during the last active period of scheduled CCM delivery. This record is used to calculate the percentage of CCM therapy pulses delivered compared to the number of right ventricular events sensed during this period. The Minimum Target CCM Therapy Rate alert is triggered if the averaged percentage of CCM therapy pulses delivered in the last three days is below the Minimum Target CCM Therapy Rate %. To set the Minimum Target CCM Therapy Rate alert and set its % value:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab 49 On the Patient Alerts panel, toggle the Minimum Target CCM Therapy Rate button to enable (ON) or disable (OFF) the alert If enabled, the default (or previously programmed) value for the Minimum Target CCM Therapy Rate Percentage parameter will now appear next to Minimum Target CCM Therapy Rate If required change the Minimum Target CCM Therapy Rate Percentage parameter o Click the numerical parameter value o Select a value from the Minimum Target CCM Therapy Rate %
parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.4 Battery Recharge Reminder Alert The Vesta Charger maintains a record of charging events. This record is used to calculate the number of days since it was last charged. The Battery Recharge Reminder alert is triggered if the number of days since the Vesta Charger lasted charged the OPTIMIZER Smart Mini IPG exceeds the programmed value of the Battery Recharge Reminder days set by the OPTIMIZER Smart Mini Programmer application. To set the Battery Recharge Reminder alert and set its days value:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Battery Recharge Reminder button to enable (ON) or disable (OFF) the alert If enabled, the default (or previously programmed) value for the Battery Recharge Reminder Days parameter will now appear next to Battery Recharge Reminder If required, change the Battery Recharge Reminder Days parameter o Click the numerical parameter value o Select a value from the Battery Recharge Reminder Days parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.5 CCM Therapy Suspended Alert The CCM Therapy Suspended alert is triggered whenever CCM therapy is suspended in the OPTIMIZER Smart Mini IPG for any reason. To set the CCM Therapy Suspended alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane 50 Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the CCM Therapy Suspended button to enable (ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.6 Long Time Without Communication With The IPG Alert The Vesta Charger keeps a record of the communication events with the OPTIMIZER Smart Mini IPG. This record is used to calculate the number of days since the Vesta Charger was able to successfully communicate with the OPTIMIZER Smart Mini IPG. The Long Time Without Communication with the IPG alert is triggered if the number of days since the Vesta Charger communicated with the OPTIMIZER Smart Mini IPG exceeds the Long Time Without Communication with the IPG days set by the OPTIMIZER Smart Mini Programmer application. To set the Long Time Without Communication with the IPG alert and set its days value:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Long Time Without Communication with the IPG button to enable (ON) or disable (OFF) the alert If enabled, the default (or previously programmed) value for the Long time without communication with the IPG days parameter will now appear next to Long Time Without Communication with the IPG If required, change the Long time without communication with the IPG days parameter o Click the numerical value o Select a value from the Long time without communication with the IPG days parameter window Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.7 Down Mode Alert The Down Mode alert is triggered whenever when the OPTIMIZER Smart Mini IPG is in DOWN Mode for any reason. To set the Down Mode alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab 51 On the Patient Alerts panel, toggle the Down Mode button to enable (ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.8 CCM Not Sensing/Noise Alert The CCM Not Sensing/Noise alert is triggered by the following conditions:
The OPTIMIZER Smart Mini IPG did not sense an RV event for 17 consecutive cycles (minimum of 30 seconds) 1000 cycles of either A or RV events in 1 day (minimum of 30 minutes of noisy cycles) To set the CCM Not Sensing/Noise alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the CCM Not Sensing/Noise button to enable (ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.9 Charger Battery Low Alert The Charger Battery Low alert is triggered whenever the charge level of the battery in the Vesta Charger drops below 10%. To set the Charger Battery Low alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Charger Battery Low button to enable
(ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.10 Charger Failure Alert The Charger Failure alert is triggered when the Vesta Charger detects and internal failure. To set the Charger Failure alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane 52 Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Charger Failure button to enable (ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.21.11 Rechargeable Battery Low Alert The Rechargeable Battery Low alert is triggered whenever the voltage of the battery in the OPTIMIZER Smart Mini IPG is 3.5 V or lower. To set the Rechargeable Battery Low alert:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Patient Alerts tab On the Patient Alerts panel, toggle the Rechargeable Battery Low button to enable (ON) or disable (OFF) the alert Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 3.22 Activity Sensor The OPTIMIZER Smart Mini IPG has a built-in accelerometer, or Activity Sensor, that allows the physician to monitor the activity level of the implanted patient. To complete the initial setup of the Activity Sensor:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Activity tab On the Activity panel, click the Activity Sensor Setup button When the Activity Sensor Setup window appears, have the patient stand upright and then click the Vertical button Have the patient assume a supine position and then click the Horizontal button Click the Save button to save the calibration Click the red X at the top right of the Activity Sensor Setup window Select the Data Storage tab On the Data Storage panel, toggle the Activity Tracking button to ON Toggle the Accelerometer, Posture, and HRV (Heart Rate Variability) buttons to ON Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter setting 53 3.23 Clock Settings for the OPTIMIZER Smart Mini IPG The date and time of the OPTIMIZER Smart Mini IPG is maintained by an internal clock and is used by the following IPG functions:
The CCM Therapy Delivery scheduling mechanism to turn the CCM Therapy ON and OFF in accordance with the programmed CCM Therapy scheduling parameters The performance of daily lead measurements (lead impedance, IEGM amplitudes, etc) The assignment of a date and time to logged events Updating of the date and time in the Vesta Charger 3.23.1 Reading the OPTIMIZER Smart Mini IPG Time The real-time clock in the OPTIMIZER Smart Mini IPG is very precise. Nevertheless, over the successive months and years, the current device time of the IPG may lose its synchronicity with the current local time. In order to read the current device time of the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Clock tab On the Clock panel, click the Read IPG Clock button 3.23.2 Setting the OPTIMIZER Smart Mini IPG Real Time Clock You can set the OPTIMIZER Smart Mini IPG real-time clock either manually or by using the computers clock. To set the current device time of the OPTIMIZER Smart Mini IPG:
If necessary, initiate a link with OPTIMIZER Smart Mini IPG o Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site o Click the Start OPTIlink button on the OPTIlink Session Pane Click the Preferences button on the Mode Bar Select the Clock tab On the Clock panel, click the Read IPG Clock button To manually set the current time of the OPTIMIZER Smart Mini IPG:
On the Clock panel, click the Set IPG Clock button When the IPGs Local time window appears, change the date and time as needed and then click the Set IPG Time button To synchronize the clock of the OPTIMIZER Smart Mini IPG to the programmers clock:
On the Clock panel, click the Synchronize IPG Clock To Programmer Clock button 54 3.24 Standards Some standard parameter combinations are useful in certain clinical situations. Specific programs can be stored as standards (also known as user presets). Files containing a standard have a special format that the OPTIMIZER Smart Mini Programmer application can interpret. The file extension used for them is .mips. The Open and Save commands of the OPTIMIZER Smart Mini Programmer application read and write data from and to .mips files. As such, the OPTIMIZER Smart Mini Programmer application can also be used as an editor of standards. On the Standards panel, click the Save Program button When the Save Standard window appears, enter a file name for the standard to 3.24.1 Saving a Standard File To save a parameter value set in a standard (.mips) file:
Click the Tools button on the Mode Bar Select the Standards tab be saved and then click Save 3.24.2 Opening a Standard File To open a standard (.mips) file:
Click the Tools button on the Mode Bar Select the Standards tab 3.25 Programmer Log On the Standards panel, click the Load Program button When the Load Standard window appears, select the file to be loaded, and then click Open Click the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new CCM parameters from the standard file When parameter values are loaded from a standard file but not yet programmed into the OPTIMIZER Smart Mini IPG, they become the current parameter values displayed by the Programmer. If any of the standards parameter values are different from the corresponding parameter values of the device, those values will be displayed in blue. The OPTIMIZER Smart Mini Programmer application keeps a log of all the interactions that take place between it and an OPTIMIZER Smart Mini IPG. This record can be used as an index to provide fast access to specific data associated with the communications. Bookmarks can also be set in order to have fast access to specific events and conditions that deserve special attention in the patients ECG. The following is a description of the basic features of the log:
The log file for a particular OPTIMIZER Smart Mini IPG is created when the device is interrogated for the first time. Each communications event that takes place between the OPTIMIZER Smart Mini Programmer application and the OPTIMIZER Smart Mini IPG appears in the Programmer Log, together with the date and time of each interaction. More information regarding an event in the log may be obtained by double-
clicking on the event in the Programmer Log. If there are data associated with the selected event, the following occurs:
o If an Interrogation or Programming event is chosen, the parameter values displayed by the OPTIMIZER Smart Mini Programmer application are the set of values present at the moment the selected event occurred. 55 o If an event such as Get Battery Capacity is chosen, the data shown is the value detected at the moment the selected event occurred. For all other recorded events (Get Session Info, etc.), no additional information regarding the event is shown in the Programmer Log. 4.0 THE VESTA CHARGER SYSTEM 4.1 Description The Vesta Charger is designed to charge the battery of the OPTIMIZER Smart Mini IPG with only minimal patient intervention while ensuring patient safety and maintaining proper operation of the IPG during the charging process. In addition, the Vesta Charger is programmed to display alerts and other messages that may require action by the patient (e.g., Call Doctor Alert Codes that require the patient to contact the doctor, reminders to charge your implanted device, etc). The Vesta Charger has a permanently attached charging wand and is powered by a rechargeable battery. To recharge this battery, the Vesta Charger System includes a Cell-Con AC Adapter
(Input: 100240 VAC, 50-60 Hz, 0.2 A; Output: 4.2 V, 1.3 A). The Vesta Charger is a Class I, Type BF device, classified as ordinary equipment suitable for continuous operation, with short-time loading, within the patient environment. Caution: The Vesta Charger is subject to interference from other electrical devices operated in the vicinity. Portable and mobile Radio Frequency (RF) equipment are especially prone to impair the normal function of the charger. If Vesta Charger is not operating as expected, such interference has to always be taken into account. The Vesta Charger communicates with the OPTIMIZER Smart Mini IPG at a frequency range of 402 MHz to 405 MHz (MedRadio frequency band). The communication range of the Vesta Charger is between 0 and at least 1.5 m (5 ft). The Vesta Charger charges the OPTIMIZER Smart Mini IPG at a frequency range of 13.56 MHz. The charging current of the Vesta Charger is fixed at 90 mA. 4.2 Charging Method The charging method utilized by the Vesta Charger to charge the battery of the OPTIMIZER Smart Mini IPG is called inductive energy transfer. Since magnetic fields can penetrate human tissues with nearly no attenuation, inductive energy transfer is the only practical transcutaneous recharging method. The manner in which inductive energy transfer is used to charge the battery of the OPTIMIZER Smart Mini IPG is as follows:
1. Electrical energy from the battery of the Vesta Charger passes through a primary coil connected to the electronic circuitry of the charger that converts it into an oscillating electromagnetic field. 2. When a primary coil is placed in close proximity to a secondary coil, the oscillating electromagnetic field generated by a primary coil is picked up by a secondary coil. 3. The secondary coil that picks up the oscillating electromagnetic field is connected to the electronic circuitry of the implant that converts it back into electrical energy. That electrical energy is used to charge the battery of the OPTIMIZER Smart Mini IPG. 56 Figure 48: Vesta Charger 4.3 System Components The Vesta Charger System consists of the following components:
Vesta Charger (with attached charging wand) used to charge the OPTIMIZER Smart Mini IPG. AC Adapter used to charge the internal battery of the Vesta Charger. EU/US Plug Adapters plug adapters for the AC Adapter, allowing the AC Adapter to be connected to wall outlets in the EU and US. Carrying Case used to store and transport the Vesta Charger System. 4.4 Features The Vesta Charger has the following features:
Graphical Display: Display screen used by the Vesta Charger to communicate information to the patient Power Button: Press-button switch used to initiate and terminate charging of the OPTIMIZER Smart Mini IPG and to silence alerts displayed by the Vesta Charger Buzzer: An internal buzzer that produces beeping tones to inform the patient of a condition that requires action Charging Wand: Wand containing a coil and circuitry used by the Vesta Charger for charging as well as short-range communications with the OPTIMIZER Smart Mini IPG Radio Transceiver: Device used by the Vesta Charger for long-range communications
[at least 1.5 m (5 ft)] with the OPTIMIZER Smart Mini IPG 57 4.5 Overview of the Screens Displayed by the Vesta Charger The Vesta Charger displays a different screen for each operational state. This section presents an overview of each screen displayed by the Vesta Charger. 4.5.1 Screens Displayed When Connected to the AC Adapter 4.5.1.1 Charger Self-Charge Status Screen This screen is displayed whenever the AC Adapter is connected to the Vesta Charger. Note: The number of bars shown on the battery icon will vary depending on the current level of charge in the Vesta Charger battery. Figure 49: Charger Self-Charge Status Screen 4.5.1.2 IPG Data Download Screen This screen is displayed whenever the Vesta Charger is actively attempting to download data from the OPTIMIZER Smart Mini IPG. The encrypted data downloaded from the device includes information regarding the current status of your IPG, statistical information regarding its operation, and any active alerts that require action. This is the first screen that is displayed after the AC Adapter is connected to the Vesta Charger and then plugged into the wall outlet. Figure 50: IPG Data Download Screen 4.5.1.3 IPG Data Download Success Screen This screen is displayed whenever the Vesta Charger has successfully completed downloading data from the OPTIMIZER Smart Mini IPG. This is the second screen that is displayed after the AC Adapter is connected to the Vesta Charger and then plugged into the wall outlet. Figure 51: IPG Data Download Success Screen 58 4.5.1.4 IPG Data Download Error Screen This screen is displayed whenever the Vesta Charger has not successfully completed downloading data from the OPTIMIZER Smart Mini IPG. Figure 52: IPG Data Download Error Screen 4.5.1.5 Charger Self-Charge Success Screen This screen is displayed whenever the AC Adapter has successfully completed charging the internal battery of the Vesta Charger. This screen may also be displayed whenever the AC Adapter is connected to the Vesta Charger and its battery charge level is above 80% or when the AC Adapter is charging the Vesta Charger and the AC Adapter current is less than 50 mA. Figure 53: Charger Self-Charge Success Screen 4.5.2 Screens Displayed When Paring with the OPTIMIZER Smart Mini IPG 4.5.2.1 Charger/IPG Pairing Screen This screen is displayed whenever the Vesta Charger is actively pairing with the OPTIMIZER Smart Mini IPG. Figure 54: Charger/IPG Pairing Screen 4.5.2.2 Charger/IPG Pairing Success Screen This screen is displayed whenever the Vesta Charger has successfully paired with the OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 short beeping tones. Figure 55: Charger/IPG Pairing Success Screen 59 4.5.2.3 Charger/IPG Pairing Error Screen This screen is displayed whenever an error has occurred during the pairing of the Vesta Charger and the OPTIMIZER Smart Mini IPG. Figure 56: Charger/IPG Pairing Error Screen 4.5.3 Screens Displayed When Charging the OPTIMIZER Smart Mini IPG 4.5.3.1 IPG Data Download Screen This screen is displayed whenever the Vesta Charger is actively downloading data from the OPTIMIZER Smart Mini IPG. This is the first screen that is displayed after pressing the Power Button on the Vesta Charger to begin a charging session. Figure 57: IPG Data Download Screen 4.5.3.2 IPG Data Download Success Screen This screen is displayed whenever the Vesta Charger has successfully completed downloading data from the OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 short beeping tones. If the Vesta Charger has successfully completed downloading data from the OPTIMIZER Smart Mini IPG, this is the second screen that is displayed after pressing the Power Button on the Vesta Charger to begin a charging session. Figure 58: IPG Data Download Success Screen 60 4.5.3.3 IPG Data Download Error Screen This screen is displayed whenever the Vesta Charger has not successfully completed downloading data from the OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 long beeping tones. If the Vesta Charger is unable to establish coupling with the OPTIMIZER Smart Mini IPG, this is the second screen that is displayed after pressing the Power Button on the Vesta Charger to begin a charging session. Figure 59: IPG Data Download Error Screen 4.5.3.4 Charging IPG Status Screen This screen is displayed whenever the Vesta Charger has successfully coupled with the OPTIMIZER Smart Mini IPG and is charging the implanted device. If the Vesta Charger has successfully coupled with the OPTIMIZER Smart Mini IPG, this is the third screen that is displayed after pressing the Power Button on the Vesta Charger. Figure 60: Charging IPG Status Screen 4.5.3.5 Charging IPG Coupling Error Screen This screen is displayed whenever the Vesta Charger is unable to establish coupling with the OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 long beeping tones. If your Vesta Charger is unable to establish coupling with the OPTIMIZER Smart Mini IPG, this is the third screen that is displayed after pressing the Power Button on the Vesta Charger. Figure 61: Charging IPG Coupling Error Screen 61 4.5.3.6 IPG Charging Successfully Completed Screen This screen is displayed whenever the Vesta Charger has successfully completed charging the battery of the OPTIMIZER Smart Mini IPG. Figure 62: IPG Charging Successfully Completed Screen 4.5.3.7 Charging IPG Timeout Error Screen This screen is displayed by the Vesta Charger whenever the charging duration of the OPTIMIZER Smart Mini IPG exceeds 5 hours 5 minutes. Figure 63: Charging IPG Timeout Error Screen 4.5.3.8 Charging IPG Temperature Error Screen This screen is displayed by the Vesta Charger whenever one of the following conditions occurs:
The reported temperature of the OPTIMIZER Smart Mini IPG at the beginning of the charging session is outside the accepted range. The charging session is suspended due to the temperature of the OPTIMIZER Smart Mini IPG remaining consistently high for more than 10 minutes. Figure 64: Charging IPG Temperature Error Screen 4.5.3.9 Power Supply Error Screen This screen is displayed whenever the AC Adapter is connected to the Vesta Charger while it is charging the OPTIMIZER Smart Mini IPG. Figure 65: Power Supply Error Screen 62 4.5.3.10 Charge Session Cancelation Screen This screen is displayed whenever the button on the Vesta Charger is pressed while it is charging the OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 short beeping tones. This screen is displayed just before the Vesta Charger shuts off. Figure 66: Charge Session Cancelation Screen 4.5.4 Screens Displayed After the Detection of an Alert Condition 4.5.4.1 Low Charger Battery Alert Screen This screen is displayed whenever the charge level of the battery in the Vesta Charger drops below 10%. The display of this screen is accompanied by short beeping tones. Figure 67: Low Charger Battery Alert Screen 4.5.4.2 Long Time Without Charging IPG Alert Screen This screen is displayed whenever the Patient Alert Battery Recharge Reminder is enabled using the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer and the number of days since the OPTIMIZER Smart Mini IPG was last charged has exceeded the number of days set for this Patient Alert. The display of this screen is accompanied by short beeping tones. Figure 68: Long Time Without Charging IPG Alert Screen 63 4.5.4.3 Long Time Without Downloading Data From IPG Alert Screen This screen is displayed whenever the Patient Alert Long Time Without Communicating with the IPG is enabled using the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer and the number of days since the last successful communication between the Vesta Charger and the OPTIMIZER Smart Mini IPG has exceeded the number of days set for this Patient Alert. The display of this screen is accompanied by short beeping tones. Figure 69: Long Time Without Downloading Data From IPG Alert Screen 4.5.4.4 Abnormal Condition Error Screen This screen is displayed whenever an abnormal condition is detected in the OPTIMIZER Smart Mini IPG or the Vesta Charger. The display of this screen is accompanied by 3 long beeping tones. Figure 70: Abnormal Condition Error Screen 4.5.4.5 Call Doctor Alert Screen This screen is displayed whenever a Call Doctor Patient Alert that is enabled by the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer has been activated. The letter displayed is specific to the model of the implanted IPG. The display of this screen is accompanied by short beeping tones. Figure 71: Call Doctor Alert Screen 4.5.4.6 Snooze Buzzer Alert Screen This screen instructs the patient to press the button on the Vesta Charger to silence the beeping tone associated with the activated alert. It is the screen that is displayed after the alert screen of a newly activated alert. Figure 72: Snooze Buzzer Alert Screen 64 4.5.4.7 Snooze Alert Screen This screen instructs the patient to press the button on the Vesta Charger to snooze an alert. It is the screen that is displayed after the alert screen if the Vesta Charger is used outside the scheduled Patient Alert Delivery period set by the OPTIMIZER Smart Mini Programmer application (usually between 08:00 and 21:00) or when an alert that was previously activated is retriggered. Figure 73: Snooze Alert Screen 4.5.5 Info Screens The Vesta Charger displays the Info Screens when the following conditions are met:
The AC Adapter is connected to the Vesta Charger. The Power Button is continuously pressed until a beeping tone is heard and then released (usually more than 5 seconds and less than 10 seconds). 4.5.5.1 First Info Screen When the Power Button is released, the First Info screen displays the following information:
The list of active and snoozed Call Doctor Alert Codes The IPG model code successful charge The battery charge level of the IPG at the completion of its last The date and time of the last successful charge of the IPG Note: The date format is (DD/MM/YY) and the time format is 24 hours. Figure 74: First Info Screen 65 4.5.5.2 Second Info Screen After the display of the First Info screen, the Second Info screen displays the following information:
The signal strength level during the last successful IPG data download session The date and time of the last successful IPG data download session Note: The date format is (DD/MM/YY) and the time format is 24 hours. Figure 75: Second Info Screen 4.6 Pairing the Vesta Charger with the OPTIMIZER Smart Mini IPG The pairing of the Vesta Charger with the OPTIMIZER Smart Mini IPG ensures that the communication and charging information received by the Vesta Charger is securely encrypted and unique to a specific implanted device. During the pairing process, the Vesta Charger uses short-range communication to search for a device to pair with and creates an encryption key once a compatible device model has been found. This encryption key is stored and used by the Vesta Charger for all its subsequent communications sessions with the paired device. To pair the Vesta Charger with the OPTIMIZER Smart Mini IPG, perform the following steps:
1. Determine the location of the OPTIMIZER Smart Mini IPG (typically right upper chest area) and then place the charging wand directly over the OPTIMIZER Smart Mini implant site (over the patients clothes). 2. Place a pairing magnet (or a standard pacemaker magnet) to the left of the Power Button on the Vesta Charger. See Figure 76. Note: A Vesta Charger being used for the first time does require the use of a magnet during the pairing process. Figure 76: Pairing Magnet on Vesta Charger 3. Begin the pairing process by pressing the Power Button, holding the button down for 1-2 seconds, and then releasing it. 66 4. The Charger/IPG Pairing screen is displayed while the Vesta Charger is actively attempting to pair with the OPTIMIZER Smart Mini IPG. See Figure 77. Figure 77: Charger/IPG Pairing Screen 5. When the pairing process has been completed, the Vesta Charger will emit 3 short beeping tones and display the Charger/IPG Pairing Success screen. See Figure 78. Figure 78: Charger/IPG Pairing Success Screen 6. Remove the pairing magnet from the Vesta Charger. 4.7 Charging the Vesta Charger Note: Advise patients to always keep their Vesta Charger connected to its AC Adapter, and the AC Adapter plugged into the wall outlet. This keeps the battery of the Vesta Charger fully charged and ready to be used, when needed, to charge the OPTIMIZER Smart Mini IPG. Note: Charging the Vesta Charger and charging the OPTIMIZER Smart Mini IPG CANNOT be done at the same time. Always charge the internal battery of the Vesta Charger before attempting to charge the battery of the OPTIMIZER Smart Mini IPG. Note: Inspect the AC Adapter for any damage before each use. Contact your Impulse Dynamics representative if a replacement AC Adapter is needed. Warning: Only use the AC Adapter provided with the Vesta Charger to charge the battery in the Vesta Charger. Otherwise damage to the Vesta Charger may result. To connect the AC Adapter to the Vesta Charger and begin charging its internal battery, perform the following steps:
1. Turn the Vesta Charger around so that the back of the charger is facing up. 2. Remove the protective cover flap from the power input connector located next to the base of the charging wand cable. 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 the Vesta Charger and then insert in the DC output connector into the power input connector. See Figure 79. Figure 79: Connection of DC Connectors 67 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 the Vesta Charger. When the Charging Self-Charge Success screen is displayed on the Vesta Charger screen, the battery in the Vesta Charger is fully charged. See Figure 80. Figure 80: Charger Self-Charge Success Screen To disconnect the AC Adapter from the Vesta Charger, perform the following steps:
1. Unplug the AC Adapter from the wall outlet. 2. Hold and pull back on the metal sleeve of the DC output connector to disconnect it from the Vesta Charger. 3. Replace the protective cover flap over the power input connector of the Vesta Charger. 4.8 Charging the OPTIMIZER Smart Mini IPG Warning: Failure to recharge the OPTIMIZER Smart Mini IPG as required may cause it to shut down when the battery is depleted, suspending CCM therapy delivery. Note: The Vesta Charger cannot be used to charge the OPTIMIZER Smart Mini IPG until the AC Adapter is disconnected from the Vesta Charger. Note: The Vesta Charger should not be operated close to other electronic equipment. If sufficient spatial separation cannot be maintained, the Vesta Charger needs to be monitored to ensure normal function. Warning: The Vesta Charger must not be used onboard an aircraft. Warning: Request permission from the ships crew prior to using your Vesta Charger onboard a ship. To charge the battery of the OPTIMIZER Smart Mini IPG, perform the following steps:
1. Place the patient in a stationary, comfortable sitting position, ideally reclining at a 45 angle (e.g., on a sofa or armchair). 2. Determine the location of the OPTIMIZER Smart Mini IPG (typically right upper chest area) and then place the charging wand directly over the OPTIMIZER Smart Mini implant site (over the patients clothes). To prevent the charging wand from becoming displaced while charging, the charging wand cable may be draped around the patients neck or the clip on the charging wand cable may be attached to the patients clothing. 3. Start the charging process by pressing the Power Button, holding the button down for 1-
2 seconds, and then releasing it. 4. The Vesta Charger will begin by displaying the IPG Data Download and IPG Data Download Success screens. See Figures 81 and 82. Figure 81: IPG Data Download Screen Figure 82: IPG Data Download Success Screen 68 5. After the data download has been completed, the Charging IPG Status screen is displayed by the Vesta Charger. See Figure 83. Figure 83: Charging IPG Status Screen The Charging IPG Status screens Coupling Level icon (
illuminated bars is proportional to the proximity of the charging wand to the implanted OPTIMIZER Smart Mini IPG, will indicate if the charging wand of the Vesta Charger needs to be repositioned. Reposition the charging wand until at least 2 bars of the Charging IPG Status screens Coupling Level icon are illuminated.
), whose number of Note: Zero illuminated bars on the Charging IPG Status screens 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. If this occurs, press the Power Button again to initiate a new charging session. 6. The number of illuminated bars on Charging IPG Battery icon (see icon image on the right) depicts the current charge level of the OPTIMIZER Smart Mini IPG. 7. The Charging IPG Status screen (see Figure 83) will continue to be displayed as the OPTIMIZER Smart Mini IPG is being charged. Note: It is recommended that the patient remain stationary during the charging process. If the charging wand becomes displaced during charging, the Charging IPG Status screens Coupling Level icon will show zero illuminated bars and the Vesta Charger will begin to emit an audible beeping tone. If this occurs, please reposition the charging wand until at least 2 bars are illuminated on the Charging IPG Status screens Coupling Level icon. Note: Instruct the patient to try to fully charge their OPTIMIZER Smart Mini IPG during the charging session. Also, inform the patient that charging the OPTIMIZER Smart Mini IPG may take longer than one hour if its battery is significantly depleted. If the patients OPTIMIZER Smart Mini IPG cannot be completely charged in one session, instruct the patient to repeat charging sessions (at least daily) until their implanted IPG is fully charged. 8. When the battery of the OPTIMIZER Smart Mini IPG is fully charged, the Vesta Charger will emit three short beeping tones and display the IPG Charging Successfully Completed screen (see Figure 84). The charging session will then be automatically terminated and the Vesta Charger will shut off. Figure 84: IPG Charging Successfully Completed Screen 69 4.8.1 Early Termination of Charging Session To terminate a charging session before it has been completed, instruct the patient to press and hold the Power Button down for one second and then releasing it again. The Vesta Charger will emit 3 short beeping tones and display the Charge Session Cancelation screen. See Figure 85. Figure 85: Charge Session Cancelation Screen Alternatively, the patient can remove the charging wand of the Vesta Charger from the implant site, which will cause the Vesta Charger to eventually shut off. Note: During the charging process, the Vesta Charger monitors the temperature of the OPTIMIZER Smart Mini IPG. To resume charging the OPTIMIZER Smart Mini IPG after terminating a charging session, please wait for approximately 10 minutes before initiating a new charging session to allow the temperature of the OPTIMIZER Smart Mini IPG to return to its baseline temperature. 4.9 Vesta Charger Placement When Not Being Used for Device Charging Whenever the Vesta Charger is not being used to charge the OPTIMIZER Smart Mini IPG, instruct the patient to place it in an area frequented by the patient (e.g., bedside table in the bedroom), connected to its AC Adapter, and the AC Adapter plugged into the wall outlet. This will keep the battery of the Vesta Charger fully charged as well as ensure regular communications between the OPTIMIZER Smart Mini IPG and the Vesta Charger. 4.10 Frequency of Charging Sessions The optimal performance of the rechargeable battery in the OPTIMIZER Smart Mini IPG is only ensured if the battery is fully recharged on a weekly basis. The day or time chosen to charge the OPTIMIZER Smart Mini IPG is not important, however, it is recommended that the patient not let more than one week pass between the charge sessions. If the Vesta Charger is not used to perform a charging session on the OPTIMIZER Smart Mini IPG within the time period set by the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer, the patient may see the Long Time Without Charging IPG alert screen (see Figure 86) displayed by the Vesta Charger. Figure 86: Long Time Without Charging IPG Alert Screen If a patient reports seeing this screen displayed by the Vesta Charger, instruct the patient to use their Vesta Charger to charge their OPTIMIZER Smart Mini IPG. If the patient reports that their attempt to charge their OPTIMIZER Smart Mini IPG with their Vesta Charger was unsuccessful, please contact your Impulse Dynamics representative. If the battery voltage of the OPTIMIZER Smart Mini IPG battery drops below 3.5 V, CCM therapy delivery is automatically suspended. If this occurs, the OPTIMIZER Smart Mini IPG battery will need to be recharged before it resumes delivering CCM therapy. Once the OPTIMIZER Smart Mini IPG has been recharged, it will automatically resume CCM therapy delivery with its previously programmed parameters. 70 4.11 Communications 4.11.1 Communications with the OPTIMIZER Smart Mini IPG The Vesta Charger is configured to communicate with the OPTIMIZER Smart Mini IPG at least once a day. This communication occurs whenever the IPG is at least 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 the time period set by the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer, the patient may see the Long Time Without Downloading Data From IPG alert screen (see Figure 87) displayed by the Vesta Charger. Figure 87: Long Time Without Downloading Data From IPG Alert Screen If a patient reports seeing this screen displayed by the Vesta Charger, instruct the patient to attempt to charge their OPTIMIZER Smart Mini IPG with their Vesta Charger. If the patient is able to charge their implanted device successfully, then the alert screen should no longer be displayed by the Vesta Charger. If the patient reports that their attempt to charge their OPTIMIZER Smart Mini IPG with their Vesta Charger was unsuccessful, please contact your Impulse Dynamics representative. 4.12 Call Doctor Alert Codes In addition to charging the OPTIMIZER Smart Mini IPG, the Vesta Charger is also able to notify the patient of an alert condition in the OPTIMIZER Smart Mini IPG that requires action. If a detected alert condition is associated with a Direct Action Alert, an alert screen such as Long Time Without Downloading Data from IPG (see Figure 87) will be displayed by the Vesta Charger. If the detected condition is associated with a Call Doctor Alert, the Vesta Charger will display a Call Doctor Alert Code (preceded by a letter denoting the IPG model code) on its screen. The display of a Call Doctor Alert Code (with the exception of code 32) is dependent on whether the specific Patient Alert associated with the Call Doctor Alert Code has been enabled using the OPTIMIZER Smart Mini Programmer application of the Intelio Programmer. Table 1: Call Doctor Alert Codes for the OPTIMIZER Smart Mini IPG Alert Code 9 19 21 23 25 27 31 32 Alert Description Prevents Charge Persistent Auto Refresh IPG Deactivated (see Section 4.12.1) Lead Impedance Change (see Section 4.12.2) CCM Therapy Suspended (see Section 4.12.3) Low IPG Battery Voltage (see Section 4.12.4) CCM Not Sensing/Noise (see Section 4.12.5) Low CCM Therapy Rate (see Section 4.12.6) Charger Failure (see Section 4.12.7) IPG has not been paired with Charger (see Section 4.12.8) Yes No No No No No Yes Yes No Yes No No Yes Yes N/A N/A Yes Yes No Yes Yes Yes N/A N/A 71 4.12.1 Call Doctor Alert Code Attributes Each Alert has the following attributes:
Prevents Charge: An alert that forces the Vesta Charger to terminate the charging process. Persistent: An alert that will be displayed even if the alert condition that triggered the event is no longer present. Auto Refresh: An alert that will be displayed again after 24 hours if the alert condition is still present. 4.12.2 Call Doctor Alert Code Definitions The OPTIMIZER Smart Mini IPG supports the following Call Doctor Alert Codes. 4.12.2.1 Alert Code 9 When Alert Code 9 is displayed, it means that the OPTIMIZER Smart Mini IPG has been deactivated and placed in DOWN Mode. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 4.12.2.2 Alert Code 19 When Alert Code 19 is displayed, it means that the OPTIMIZER Smart Mini IPG has detected a significant change in the impedance in one or both ventricular leads. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 4.12.2.3 Alert Code 21 When Alert Code 21 is displayed, it means that CCM therapy in the OPTIMIZER Smart Mini IPG has been suspended. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 4.12.2.4 Alert Code 23 When Alert Code 23 is displayed, it means that the battery voltage level in the OPTIMIZER Smart Mini IPG is less than 3.6 V. If this Alert Code is displayed by the Vesta Charger, please charge the OPTIMIZER Smart Mini IPG battery as soon as possible to prevent CCM therapy from becoming suspended. 4.12.2.5 Alert Code 25 When Alert Code 25 is displayed, it means that the OPTIMIZER Smart Mini IPG has detected that an implanted lead is not sensing or sensing an excessive amount of noise. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 4.12.2.6 Alert Code 27 When Alert Code 27 is displayed, it means that the OPTIMIZER Smart Mini IPG has detected that the amount of CCM therapy delivered is below the alert level programmed into the implanted device by the Intelio Programmer. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 4.12.2.7 Alert Code 31 When Alert Code 31 is displayed, it means that the Vesta Charger has detected repeated internal errors during its operation. If this Alert Code is displayed by the Vesta Charger, please contact your Impulse Dynamics representative. 72 4.12.2.8 Alert Code 32 When Alert Code 32 is displayed, it means that the Vesta Charger has determined that it is attempting to be used on an unrecognized device. If this Alert Code is displayed by the Vesta Charger, please pair the implanted OPTIMIZER Smart Mini IPG with the Vesta Charger and then restart the charging process. If this code is still displayed after the Vesta Charger has been successfully paired with the implanted OPTIMIZER Smart Mini IPG, please contact your Impulse Dynamics representative. 4.13 Cleaning Warning: Always unplug the AC Adapter from the Vesta Charger prior to cleaning. The exterior surface of the Vesta Charger should 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 the Vesta Charger in water. Damage to the unit may result. The Vesta Charger has limited protection against the ingress of water or humidity (ingress protection rating IP22). Warning: DO NOT sterilize any part of the Vesta Charger because any such attempt could severely damage the equipment. 4.14 Maintenance The Vesta Charger does not contain any user-serviceable parts. If the Vesta Charger is not operational, please contact your Impulse Dynamics representative to obtain a replacement charger. Warning: No modification of this equipment is allowed. The battery inside the Vesta Charger is expected to have a service life of 5 years. If the Vesta Charger is unable to fully charge an OPTIMIZER Smart Mini IPG or OPTIMIZER IVs IPG after the charger battery has been fully charged, please contact your Impulse Dynamics representative to obtain a replacement charger. 4.15 Storage and Handling The Vesta Charger System is designed to maintain functionality after it has been exposed to the following environmental extremes:
Ambient Temperature: -20C to +60C (-4F to 140F) Relative Humidity: 10% to 100% (with or without condensation) Atmospheric Pressure: 500 hPa to 1560 hPa (14.81 inHg to 46.20 inHg) The Vesta Charger System should not be exposed to excessively hot or cold storage conditions. Patients should be instructed not to leave the Vesta Charger System in their car or outdoors for extended periods of time. The sensitive electronics of the Vesta Charger System can be damaged by temperature extremes, particularly high heat. For proper operation, the Vesta Charger should be used only under the following environmental conditions:
Ambient Temperature: 10C to 27C (50F and 81F) Relative Humidity: 20% to 75%
Atmospheric Pressure: 700 hPa to 1060 hPa (20.73 inHg to 31.39 inHg) Note: When not being used to charge the OPTIMIZER Smart Mini IPG, the Vesta Charger should always be connected to its AC Adapter, and the AC Adapter plugged into the wall outlet 73 4.16 Disposal If the Vesta Charger is no longer needed by the patient and is returned, please notify your Impulse Dynamics representative of its return. Warning: DO NOT discard the Vesta Charger in the trash bin. The Vesta Charger contains Lithium batteries as well as non-RoHS components. If disposal of the Vesta Charger is necessary, properly dispose of the Vesta Charger in accordance with local regulations governing the disposal of such material. 74 APPENDIX I Statement of FCC Compliance FCC Compliance of Intelio Programmer with Intelio Programming Wand The Intelio Programmer with Intelio Programming Wand has been tested and found to comply with the limits pursuant to the following parts of the FCC rules:
47 CFR Part 15 Subpart C Intentional Radiators 47 CFR Part 95 Subpart I - Medical Device Radio Communications Service These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Operation is subject to the following conditions:
This device may not cause harmful interference. This device may not interfere with stations operating in the rate range of 400.150
- 406.000 MHz in the meteorological aids, meteorological satellite, and earth exploration satellite services and must handle any interference received, including interference that may cause undesired operation. This device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by the manufacturer could void the users authority to operate the equipment under FCC rules. FCC Compliance of Vesta Charger The Vesta Charger has been tested and found to comply with the limits pursuant to the following parts of the following FCC rules:
47 CFR Part 18 Industrial, Scientific, and Medical Equipment 47 CFR Part 95 Subpart I - Medical Device Radio Communications Service These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
75 Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Operation is subject to the following conditions:
This device may not cause harmful interference. This device may not interfere with stations operating in the rate range of 400.150
- 406.000 MHz in the meteorological aids, meteorological satellite, and earth exploration satellite services and must handle any interference received, including interference that may cause undesired operation This device must accept any interference received, including interference that may cause undesired operation. This transmitter is authorized by rule under the Medical Device Radiocommunication 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 that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. Modifications not expressly approved by the manufacturer could void the users authority to operate the equipment under FCC rules. This device complies with part 18 of the FCC Rules. The use of the Vesta Charger can interrupt RFIDs or other communications systems that utilize the use of the 13.56MHz ISM band. 76 Electromagnetic Immunity Electromagnetic Immunity of the Intelio Programmer GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC IMMUNITY OF THE INTELIO PROGRAMMER The INTELIO Programmer, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer must ensure that it is used within the specified environment. Essential Performance of the INTELIO Programmer:
The Programming System shall be able to program the IPG with a safe program. It is allowable that this may require an occasional reattempt. The Programming System shall be able to reprogram the IPG with a desired program. It is allowable that this may require an occasional retrying of the programming operation, or restarting the computer. The Programming System shall only program the intended program and show as retrieved critical data the current set stored in the 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 (23 seconds), sets the OPTIMIZER Smart Mini IPG into Magnet Mode, suspending CCM therapy. Immunity test IEC 60601-1-2:2014 test level Compliance level Electrostatic discharge as defined in IEC 61000-4-2 Electrical fast transient / burst as defined in IEC 61000-4-4 Contact Discharge:
8 kV Contact Discharge:
8 kV Air Discharge:
2 kV, 4 kV, 8 kV, and 15 kV Air Discharge:
2 kV, 4 kV, 8 kV, and 15 kV 2 kV for mains power supply 2 kV for mains power supply 1 kV for in-/output lines 1 kV for in-/output lines AC line voltage surges as defined in IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines as defined in IEC 61000-4-11 Line-to-Earth 2 kV;
Line-to-Line 1 kV Line-to-Earth 2 kV;
Line-to-Line 1 kV Dips: 100% reduction for 0.5/1 cycles Dips: 100% reduction for 0.5/1 cycles 30% reduction for 25/30 cycles 30% reduction for 25 cycles Interruptions: 100%
reduction for 250/300 cycles Interruptions: 100%
reduction for 250 cycles Electromagnetic environment -
guidelines Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be 30% or greater. Mains power quality should be that of a typical professional healthcare or hospital environment. Do not operate motors or other noisy electrical equipment on the same mains circuit as the VESTA Charger. Mains power quality should be that of a typical professional healthcare or hospital environment. Mains power quality should be that of a typical professional healthcare or hospital environment. Note: If the user of the INTELIO Programmer requires uninterrupted operation during power mains interruptions, it is recommended to power the VESTA Charger from an uninterruptible power supply. 77 Power line frequency magnetic fields
(50/60 Hz) as defined in IEC 61000-4-8 Conducted RF as defined in IEC 61000-4-
6:2013 Radiated RF as defined in IEC 61000-4-3: 2006
+A1: 2007 +A2:
2010 3 A/m 3 A/m 3 V r.m.s outside industrial, scientific, and medical (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 3 V r.m.s outside industrial, scientific, and medical (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 10 V/m: 80 MHz to 2.7 GHz and wireless frequencies 10 V/m: 80 MHz to 2.7 GHz and wireless frequencies Power line frequency magnetic fields (50/60 Hz) should be at levels expected in a typical professional healthcare or hospital environment. 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 = 1.17P d = 1.17P 80 MHz to 800 MHz d = 2.33P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
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. If the measured field strength in the location where the INTELIO Programmer is used exceeds the applicable RF compliance level above, the INTELIO Programmer should be monitored to ensure normal operation. If an abnormal function is observed, additional measures may be necessary, such as relocating the INTELIO Programmer. b - For frequencies in the range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m. 78 Electromagnetic Immunity of the Vesta Charger GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC IMMUNITY OF THE VESTA CHARGER Essential Performance of the VESTA Charger:
The VESTA Charger shall not charge the OPTIMIZER Smart Mini IPG inappropriately. The patient shall be made aware of inappropriate charging either by an explicit message, or by the absence of an expected message from the 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. The test levels follow FDA recommendations for the home environment per Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff, November 24, 2014 Immunity test IEC 60601-1-2:2014 test level Compliance level Electrostatic discharge as defined in IEC 61000-4-2 Electrical fast transient / burst as defined in IEC 61000-4-4 Contact Discharge:
8 kV Contact Discharge:
8 kV Air Discharge:
2 kV, 4 kV, 8 kV, and 15 kV Air Discharge:
2 kV, 4 kV, 8 kV, and 15 kV 2 kV for mains power supply 2 kV for mains power supply 1 kV for in-/output lines 1 kV for in-/output lines Line-to-Earth 2 kV;
Line-to-Line 1 kV Line-to-Earth 2 kV;
Line-to-Line 1 kV Dips: 100% reduction for 0.5/1 cycles Dips: 100% reduction for 0.5/1 cycles 30% reduction for 25/30 cycles 30% reduction for 25/30 cycles Interruptions: 100%
reduction for 250/300 cycles Interruptions: 100%
reduction for 250/300 cycles 3 A/m 3 A/m AC line voltage surges as defined in IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines as defined in IEC 61000-4-11 Power line frequency magnetic fields
(50/60 Hz) as defined in IEC 61000-4-8 Electromagnetic environment -
guidelines Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be 30% or greater. Mains power quality should be that of a typical home healthcare, business, or hospital environment. Do not operate motors or other noisy electrical equipment on the same mains circuit as the VESTA Charger. Mains power quality should be that of a typical home healthcare, business, or hospital environment. Mains power quality should be that of a typical home healthcare, business, or hospital environment. Note: If the user of the VESTA Charger requires uninterrupted operation during power mains interruptions, it is recommended to power the VESTA Charger from an uninterruptible power supply. Power line frequency magnetic fields (50/60 Hz) should be at levels expected in a typical home healthcare, business, or hospital environment. 79 Conducted RF as defined in IEC 61000-4-
6:2013 Radiated RF as defined in IEC 61000-4-3: 2006
+A1: 2007 +A2:
2010 3 V r.m.s outside industrial, scientific, and medical (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 3 V r.m.s outside industrial, scientific, and medical (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 10 V/m: 80 MHz to 2.7 GHz and wireless frequencies 10 V/m: 80 MHz to 2.7 GHz and wireless frequencies 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 = 1.17P d = 1.17P 80 MHz to 800 MHz d = 2.33P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
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. If the measured field strength in the location where the VESTA Charger is used exceeds the applicable RF compliance level above, the VESTA Charger should be monitored to ensure normal operation. If an abnormal function is observed, additional measures may be necessary, such as relocating the VESTA Charger. b - For frequencies in the range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m. 80 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Intelio Programmer or Vesta Charger Recommended separation distances between portable and mobile RF communications equipment and the Intelio Programmer or Vesta Charger The Intelio Programmer or the Vesta Charger should be used in an electromagnetic environment with limited radiated RF noise. The customer or user of the Intelio Programmer or the Vesta Charger can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communications equipment (transmitters) and the Intelio Programmer or the Vesta Charger recommended below, which is determined by the maximum output power of the communications equipment. Rated maximum output power of transmitter
(W) Separation distance broken down by transmitter frequency(m) 150 kHz to 80 MHz1 d = 1.17P 80 MHz to 800 MHz1 d = 1.17P 800 MHz to 2.5 GHz d = 2.33P 0.01 0.1 1 10 100 0.12 0.37 1.17 3.70 11.70 0.12 0.37 1.17 3.70 11.70 0.23 0.75 2.33 7.36 23.30 For transmitters with a maximum rated output power not listed above, the recommended separation distance d in meters (m) can be estimated by using the equation applicable to the frequency of the transmitter, where P is the maximum rated output power of the transmitter in watts (W) specified by the transmitter manufacturer. 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply to all settings. Electromagnetic propagation is affected by absorption and reflection from buildings, objects, and people. 81 Electromagnetic Emissions Electromagnetic Emissions from the Intelio Programmer with Intelio Programming Wand The Intelio Programmer with Intelio Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Warning: The Intelio Programmer with Intelio Programming Wand must not be used onboard an aircraft. Warning: Permission must be requested from a ships crew prior to using the Intelio Programmer with Intelio Programming Wand onboard a ship. FCC 47 CFR 95 Subpart I - Medical Device Radio Communications Service GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND PURSUANT TO:
FCC - 47 CFR 95 Subpart I - Medical Device Radio Communications Service The INTELIO Programmer with INTELIO Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer must ensure that it is used within the specified environment. Emissions Test Compliance Duration of Transmissions Complies with clause 95.2557 Frequency Monitoring Complies with clause 95.2559 Frequency Accuracy Complies with clause 95.2565 EIRP Field Strength Bandwidth Complies with clause 95.2567(a) Complies with clause 95.2569 Complies with clause 95.2573 Unwanted Emissions Complies with clause 95.2579 Permissible Exposure Evaluation Complies with clause 95.2585 Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. 82 ETSI EN 301 839 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND PURSUANT TO:
ETSI EN 301 839 V2.1.1 - Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The INTELIO Programmer with INTELIO Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer must ensure that it is used within the specified environment. Emissions Test Compliance Frequency Error Complies with clause 5.3.1 Occupied Bandwidth Complies with clause 5.3.2 Power Output Transmitter Spurious Emissions
(30 MHz to 6 GHz) Frequency Stability Under Low Voltage Conditions Complies with clause 5.3.3 Complies with clause 5.3.4 Complies with clause 5.3.5 Spurious Radiation of Receivers Complies with clause 5.3.6 Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. 83 ETSI EN 301 489-1 and ETSI EN 301 489-27 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND PURSUANT TO:
ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility ETSI EN 301 489-27 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) operating in the 402 MHz to 405 MHz bands;
Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU The INTELIO Programmer with INTELIO Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer 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 Radiated Emissions EN 55032:2012/AC:2013 Class B Conducted Emissions EN 55032:2012/AC:2013 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Class B Class A Pass for all parameters Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 84 IEC 60601-1-2 2014 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND PURSUANT TO:
IEC 60601-1-2 2014, Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- Requirements and tests The INTELIO Programmer with INTELIO Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer 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 Radiated Emissions CISPR 11: 2009 + A1:2010 Group 2, Class A Conducted Emissions CISPR 11: 2009 + A1:2010;
FCC 18 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Group 1, Class B Class A Pass for all parameters Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 85 Electromagnetic Emissions from the Intelio Programmer with Legacy Programming Wand The Intelio Programmer with Legacy Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Warning: The Intelio Programmer with Legacy Programming Wand must not be used onboard an aircraft. Warning: Permission must be requested from a ships crew prior to using the Intelio Programmer with Legacy Programming Wand onboard a ship. FCC - 47 CFR Part 15 Intentional Radiators GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH LEGACY PROGRAMMING WAND PURSUANT TO:
FCC - 47 CFR Part 15 Intentional Radiators The INTELIO Programmer with LEGACY Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer must ensure that it is used within the specified environment. Emissions Test Compliance Fundamental Radiated 15.209 Complies with clause 15.209 Conducted Emissions 15.207 Complies with clause 15.207 Spurious Emissions Complies with clause 15.209 Permissible Exposure Evaluation 1.1307(b) and 2.1093 exposure limit satisfied Electromagnetic environment - guidelines The INTELIO Programmer with LEGACY Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. ETSI EN 302 195 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH LEGACY PROGRAMMING WAND PURSUANT TO:
ETSI EN 302 195 V2.1.1 - Short Range Devices (SRD);Ultra Low Power Active Medical Implants
(ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The INTELIO Programmer with LEGACY Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer must ensure that it is used within the specified environment. Emissions Test Compliance Electromagnetic environment - guidelines The INTELIO Programmer with LEGACY Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Radiated Field Strength Complies with clause 4.2.1 Modulation Bandwidth Complies with clause 4.2.2 Transmitter Spurious Emissions
(9 kHz to 30 MHz) Complies with clause 4.2.3 Duty Cycle Complies with clause 4.2.4 Receiver Blocking Complies with clause 4.3.2 Receiver Spurious Emissions
(9 kHz to 30 MHz) Complies with clause 4.3.3 86 ETSI EN 301 489-1 and EN 301 489-31 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH LEGACY PROGRAMMING WAND PURSUANT TO:
ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility EN 301 489-31 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P);
Harmonised Standard covering the essential requirements of article 3.1(b) of the Directive 2014/53/EU The INTELIO Programmer with LEGACY Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer 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 Radiated Emissions CISPR 11:2009 + A1:2010 Group 2, Class A Conducted Emissions EN 55032:2012/AC:2013 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Class B Class A Pass for all parameters Electromagnetic environment - guidelines The INTELIO Programmer with LEGACY Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The INTELIO Programmer with LEGACY Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 87 IEC 60601-1-2 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE INTELIO PROGRAMMER WITH LEGACY PROGRAMMING WAND PURSUANT TO:
IEC 60601-1-2 2014, Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- Requirements and tests The INTELIO Programmer with LEGACY Programming Wand, part of the OPTIMIZER Smart Mini System is intended for use in an electromagnetic environment as specified below. The customer or user of the INTELIO Programmer 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 Radiated Emissions CISPR 11:2009 + A1:2010 Group 2, Class A Conducted Emissions CISPR 11: 2009 + A1:2010 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Group 2, Class B Class A Pass for all parameters Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 88 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 ships crew prior to using the Vesta Charger onboard a ship. 47 CFR Part 18 Industrial, Scientific, and Medical Equipment GUIDELINES AND MANUFACTURERS 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 Test Compliance Conducted Emissions Radiated Emissions 18.307(b) 18.305(b) Electromagnetic environment - guidelines The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. FCC 47 CFR 95 Subpart I - Medical Device Radio Communications Service GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC 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 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 Test Compliance Electromagnetic environment - guidelines The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Duration of Transmissions Complies with clause 95.2557 Frequency Monitoring Complies with clause 95.2559 Frequency Accuracy Complies with clause 95.2565 EIRP Field Strength Bandwidth Complies with clause 95.2567(a) Complies with clause 95.2569 Complies with clause 95.2573 Unwanted Emissions Complies with clause 95.2579 Permissible Exposure Evaluation Complies with clause 95.2585 89 ETSI EN 301 839 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO:
ETSI EN 301 839 V2.1.1 - Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 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. Emissions Test Compliance Frequency Error Complies with clause 5.3.1 Occupied Bandwidth Complies with clause 5.3.2 Power Output Transmitter Spurious Emissions
(30 MHz to 6 GHz) Frequency Stability Under Low Voltage Conditions Complies with clause 5.3.3 Complies with clause 5.3.4 Complies with clause 5.3.5 Spurious Radiation of Receivers Complies with clause 5.3.6 Electromagnetic environment - guidelines The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. 90 ETSI EN 301 489-1 and ETSI EN 301 489-27 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO:
ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility ETSI EN 301 489-27 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) operating in the 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. There may be potential difficulties in ensuring electromagnetic compatibility in other environments, due to conducted as well as radiated disturbances Emissions Test Compliance Radiated Emissions EN 55032:2012/AC:2013 Class B Conducted Emissions EN 55032:2012/AC:2013 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Class B Class A Pass for all parameters Electromagnetic environment - guidelines The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The INTELIO Programmer with INTELIO Programming Wand must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 91 IEC 60601-1-2 2014 GUIDELINES AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMMISSIONS OF THE VESTA CHARGER PURSUANT TO:
IEC 60601-1-2 2014, Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - 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. There may be potential difficulties in ensuring electromagnetic compatibility in other environments, due to conducted as well as radiated disturbances Emissions Test Compliance Radiated Emissions CISPR 11: 2009 + A1:2010 Group 1, Class B Conducted Emissions CISPR 11: 2009 + A1:2010;
FCC 18 AC Harmonic Emissions IEC 61000-3-2:2014 Voltage Flicker IEC 61000-3-3:2013 Group 2 Class A Pass for all parameters Electromagnetic environment - guidelines The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The Vesta Charger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class A equipment is equipment suitable for use in all establishments other than domestic buildings, and Class B equipment is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 92 APPENDIX II Wireless Technology RF wireless technology is used in the communication between an OPTIMIZER SMART MINI Implantable Pulse Generator (IPG) and an INTELIO Programmer. 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, 402405 MHz) of the MedRadio Band. The OPTIlink encrypted MICS channel is established after the IPG is positively identified and encryption keys are exchanged via a very-short-range (<4 cm) communication over the 13.56 MHz recharge channel. RF wireless technology is also used to transcutaneously transmit energy from the VESTA Charger to recharge the OPTIMIZER SMART MINI IPG at the 13.56 MHz ISM frequency. The transmission range is specified at a maximum of 4 cm between the Chargers coil and the IPGs receiving coil. Control over the recharge process, as well as the communications of alert messages from the IPG to the Charger take place over an encrypted MICS channel. Lastly, the LEGACY Programming Wand, which is part of the INTELIO Programming System is capable of communicating with the OPTIMIZER SMART IPG using short-range (<5 cm) magnetic-coupling telemetry. Intelio Programmer with Intelio Programming Wand Wireless Nominal Specifications Characteristic Nominal OPTIlink MICS MedRadio Frequency Band Bandwidth Modulation Radiated Power Range Bandwidth Modulation Radiated Power Range 402 405 MHz Medical Implant Communication Service (MICS) Medical Device Radio Communication Service (MedRadio)
< 145 kHz FSK
< 25 W E.I.R.P. 0 to at least 1.5 m Industrial, Scientific, and Medical radio band (ISM)
<0.014 MHz PPM
<7 mW 5 mm to 40 mm Recharge Channel Communication Frequency Band 13.56 MHz 100 ppm 93 Frequency Band Modulation Radiated Power Range Frequency Band Modulation Radiated Power Range MICS MedRadio Frequency Band Bandwidth Modulation Radiated Power Range Bandwidth Modulation Radiated Power Range Intelio Programmer with Legacy Wand Wireless Nominal Specifications Note: Programming Application Software is not currently available for the INTELIO Programmer to program the OPTIMIZER Smart IPG Characteristic Nominal Legacy Programming Wand to OPTIMIZER Smart IPG OPTIMIZER Smart IPG to Legacy Wand Vesta Charger Wireless Nominal Specifications Characteristic Nominal 23 kHz 100% AM: 0 = no carrier, 1 = carrier for 305 s 0.56 Wpeak; 0.27 Waverage 5 mm to 50 mm 14.5 kHz LC excited by pulse; 1 cycle per pulse until dampened to 10%
PPM: 0 = 180 s, 1 = 270 s 5.14 mWpeak per pulse; 1.8 mWaverage 5 mm to 50 mm 402 405 MHz Medical Implant Communication Service (MICS) Medical Device Radio Communication Service (MedRadio)
< 145 kHz FSK
< 25 W E.I.R.P. 0 to at least 1.5 m Industrial, Scientific, and Medical radio band (ISM)
<0.014 MHz Amplitude (slow to optimize coupling, no data)
<0.6 W 5 mm to 40 mm 94 Transcutaneous Energy Transfer Frequency Band 13.56 MHz Quality of Service (QoS) for Wireless Technology QoS for Communications between the Intelio Programmer 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 INTELIO Programmer. Before the Intelio Programmer can be used to program the OPTIMIZER Smart Mini IPG, an OPTIlink communication session must first be established between the Intelio Programmer and the IPG. This is accomplished by means of the Intelio Programming Wand, which must be placed over the implant site and within 4 cm of the IPG. Once the Intelio Programming Wand is over the patients implant site, the communication link is established by initiating the Start OPTIlink command. Encryption keys are exchanged through a proprietary process using the 13.56 MHz Recharge Channel, after which the Intelio Programming Wand can be placed at a distance of up to 1.5 m away from the implant site, with communications taking place over MedRadio. The OPTIlink Signal Strength Indicator dynamically displays the Quality of Service (QoS) for the link between the Intelio Programming Wand and the OPTIMIZER Smart Mini IPG. Depending on the quality of the link, the curved waves of the Signal Strength Indicator are displayed in the following manner:
Good quality link 3 green signal waves Medium quality link 2 yellow signal waves Low quality link 1 red signal wave 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 requirements for the Quality of Service (QoS) vary depending on the use environment (operating room, recovery room, clinic, and home environment). The Vesta Charger will 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:
95 The Charging IPG Status screens Coupling Level icon (
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 transcutaneous energy transmission wireless link. The charging wand should be repositioned until at least 2 bars of the Charging IPG Status screens Coupling Level icon are illuminated, indicating sufficient QoS for charging the OPTIMIZER Smart Mini IPG.
), whose number of One illuminated bar indicates degraded QoS which may require a longer charging time. Zero illuminated bars on the Charging IPG Status screens 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. Besides charging the OPTIMIZER Smart Mini, the Vesta Charger also serves as a way of messaging the patient about alerts and other conditions. The Vesta Charger is configured to communicate with the OPTIMIZER Smart Mini IPG at least once a day. This communication occurs whenever the IPG is at least 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 case, instruct the patient to attempt to charge their OPTIMIZER Smart Mini IPG with their Vesta Charger. If the patient is able to charge their implanted device successfully, then the alert screen should no longer be displayed by the Vesta Charger. If the attempt to charge the OPTIMIZER Smart Mini IPG with the Vesta Charger is unsuccessful, the Impulse Dynamics representative should be contacted. Wireless Security Measures Wireless Security Measures in OPTIlink Communications between OPTIMIZER Smart Mini IPG and Intelio Programmer OPTIlink wireless signals are secured through device system design that includes the following:
Establishing an OPTIlink communications channel requires the Intelio Programming Wand to be placed within 4 cm of the OPTIMIZER Smart Mini IPG. The 13.56 MHz short-range channel is used as part of a proprietary process to authenticate the devices and securely exchange encryption keys. The OPTIMIZER Smart Mini IPG and the Intelio Programmer encrypt their wireless communications using encryption keys that are randomly generated for each OPTIlink session. Only one Intelio Programmer may communicate with the IPG at the same time. 96 Troubleshooting for Wireless Coexistence Issues Wireless Security Measures in Communications between OPTIMIZER Smart Mini IPG and Vesta Charger Pairing of the Vesta Charger with the OPTIMIZER Smart Mini IPG ensures that the communication and charging information received by the Vesta Charger is securely encrypted and unique to a specific implanted device. During the pairing process, the Vesta Charger uses short-range communication to search for a device to pair with and creates an encryption key once a compatible device model has been found. This encryption key is stored and used by the Vesta Charger for all its subsequent communications sessions with the paired device. Wireless signals are secured through device system design that includes the following:
Pairing of a Vesta Charger and an OPTIMIZER Smart Mini IPG requires the placing of a pairing magnet on the Vesta Charger, and locating the Charge Wand within 4 cm of the OPTIMIZER Smart Mini IPG. The 13.56 MHz short-range channel is used as part of a proprietary process to pair the devices and exchange encryption keys. The OPTIMIZER Smart Mini IPG and the Vesta Charger encrypt their wireless communications using encryption keys that are generated during the pairing process. Only one Vesta Charger can be paired with the IPG at any one time. Troubleshooting OPTIlink Connection between the OPTIMIZER Smart Mini IPG and the Intelio Programmer If you experience issues with establishing an OPTIlink session between the OPTIMIZER Smart Mini IPG and the Intelio Programmer, try the following:
Reposition the Intelio Programming Wand so that it lays parallel to the IPGs plane and its center is coaxial with the center of the IPGs header. Decrease the distance between the devices. Move the devices away from other devices that may be causing interference. Do not operate other wireless devices (i.e., programmers for other devices, laptop, tablet, mobile phone, or cordless phone) at the same time. If you experience issues with maintaining an OPTIlink session between the OPTIMIZER Smart Mini IPG and the Intelio Programmer, try the following:
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, laptop, tablet, mobile phone, or cordless phone) at the same time. Wait a few minutes and try connecting again NOTE: Wireless communications equipment, such as wireless home network devices, mobile and cordless telephones, and tablets, could affect the quality of the OPTIlink connection. 97 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., bedside table in the bedroom), connected to its AC Adapter, and the AC Adapter plugged into the wall outlet. 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, laptop, tablet, mobile phone, or cordless phone) at the same time. Wait a few minutes and try connecting again. NOTE: Wireless communications equipment, such as wireless home network devices, mobile and cordless telephones, and tablets, could affect the quality of the wireless connection. APPENDIX III Security of the Intelio Programmer Unit How the Programmer Promotes Security All installed software in the Intelio Programmer Unit has been approved by Impulse Dynamics. It is not possible to install general-purpose software on the programmer. Controlling installed software minimizes the potential for vulnerabilities. Internal software that runs the programmer is locked from change. Every time the programmer is started, a clean version of the installed software is used. The disk drive is encrypted. What Hospitals and Clinics Can Do To Promote the Security of Programmers It is very important to maintain good physical controls over the Intelio Programmer. Having a secure physical environment prevents access to the internals of the Programmer and its components. USB devices connected to the Programmer should be strictly controlled to limit potential introduction of malware. Information regarding programmed IPGs and programming sessions may be stored in the Intelio Programmer, and thus appropriate precautions should be taken to secure the Programmer from unauthorized access. 98 APPENDIX IV Procedure for IPG-ICD Interaction Testing:
Patients with a concomitantly-implanted defibrillator (ICD) require additional testing at the end of the implant procedure to ensure the appropriate function of both the OPTIMIZER Smart Mini IPG and the concomitant device. The steps of the required testing procedure are as follows:
1. Program the ICD so that it does not deliver antitachycardic therapy during this test. 2. Enable CCM therapy and program the sensing windows of the OPTIMIZER Mini IPG to consistently deliver CCM therapy in the presence of the concomitant device. 3. Extend the CCM Train Delay by a minimum of 40 ms up to 50 ms beyond the chronic CCM Train Delay setting repeatedly and observe the real-time intracardiac electrograms
(ICD-EGM) to determine the maximum amount of CCM Train Delay allowed before the ICD begins to inappropriately sense the CCM therapy pulses as R waves. 4. Document the maximum CCM Train Delay and enter the information as part of the Implant data. 5. Reprogram the CCM Train Delay to the pre-test value. 6. Document reprogramming of the CCM Train Delay with a parameter printout of the IPG 7. Reprogram the ICD so that it is able to deliver antitachycardic therapy. 8. Obtain the minimum R-R interval ICD VT zone from the ICD programmer or printout and enter the information as part of the Implant data. 9. Document reactivation of the antitachycardic therapy with a parameter printout of the ICD setting. setting. 99
1 | Internal Photos | Internal Photos | 2.03 MiB | September 27 2021 / March 26 2022 | delayed release |
1 | External Photos | External Photos | 264.10 KiB | September 27 2021 / March 26 2022 | delayed release |
1 | Label Information | ID Label/Location Info | 154.30 KiB | September 27 2021 / September 28 2021 |
Figure 1: Picture of the Vesta Charger back label. Figure 2: Label location placed on the Vesta Charger enclosure
1 | Agency Agreement Letter | Cover Letter(s) | 116.02 KiB | September 27 2021 / September 28 2021 |
6/21/2021 Impulse Dynamics USA Inc. 50 Lake Center Executive Parkway 401 Route 73N, Bldg. 50, Suite 100 Marlton, NJ 08053-3449 Professional Testing (EMI) Inc. 1601 N. A.W. Grimes Blvd, Suite B Round Rock, TX 78665 To whom it may concern:
This letter authorizes Eric Lifsey of Profession Testing (EMI) Inc. as agent for Impulse Dynamics USA Inc. regarding all matters relating to applications for equipment authorization, including signing of all documents relating to these matters to FCC certification for FCC ID 2AY43-GDCH0 for Impulse Dynamics. This authorization is effective until December 21, 2021. Sincerely, Jordan Thimot, Ph.D. Impulse Dynamics USA Inc. Product Development Engineer
1 | Confidentiality Request | Cover Letter(s) | 166.70 KiB | September 27 2021 / September 28 2021 |
6/21/2021 Impulse Dynamics USA Inc. 50 Lake Center Executive Parkway 401 Route 73N, Bldg. 50, Suite 100 Marlton, NJ 08053-3449 Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: 2AY43-GDCH0 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, Impulse Dynamics USA Inc. hereby requests permanent confidential treatment of information accompanying this application as outlined below:
Schematics Bill of Materials/Parts List/Tune Up Procedures Block Diagrams Operational Description Impulse Dynamics USA Inc. also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of period of 180 days:
Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Sincerely, Jordan Thimot, Ph.D. Impulse Dynamics USA Inc. Product Development Engineer
1 | Test Setup Photos | Test Setup Photos | 150.77 KiB | September 27 2021 / March 26 2022 | delayed release |
frequency | equipment class | purpose | ||
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1 | 2021-09-28 | 402 ~ 405 | TNT - Licensed Non-Broadcast Transmitter Worn on Body | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2021-09-28
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1 | Applicant's complete, legal business name |
Impulse Dynamics USA
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1 | FCC Registration Number (FRN) |
0030625453
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1 | Physical Address |
50 Lake Center Executive Parkway 401 Route 73N, Building 50, Suite 100
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1 |
50 Lake Center Executive Parkway
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|||||
1 |
Marlton, NJ
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|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
j******@tuvsud.com
|
||||
1 | TCB Scope |
B2: General Mobile Radio And Broadcast Services equipment in the following 47 CFR Parts 22 (non-cellular) 73, 74, 90, 95, 97, & 101 (all below 3 GHz)
|
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app s | FCC ID | |||||
1 | Grantee Code |
2AY43
|
||||
1 | Equipment Product Code |
GDCH0
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** A******** T****
|
||||
1 | Title |
Product Development Engineer
|
||||
1 | Telephone Number |
85643********
|
||||
1 | Fax Number |
85664********
|
||||
1 |
j******@impulsedynamics.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/26/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | TNT - Licensed Non-Broadcast Transmitter Worn on Body | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | MedRadio | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power is EIRP | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Professional Testing (EMI), Inc.
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1 | Name |
L******** F********
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1 | Telephone Number |
512-2******** Extension:
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1 | Fax Number |
512-2********
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1 |
l******@ptitest.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 95I | 402.00000000 | 405.00000000 | 0.0000170 | 100.0000000000 ppm | 248KG1D |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC