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Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual

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Intelio Programmer for
®
OPTIMIZER
Smart Mini and
®
OPTIMIZER
Smart Systems
INSTRUCTIONS FOR USE
Federal (US) law restricts this device to sale by or on the order of a physician
Part No.: 13-290-020-US Rev. 01

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Summary of Contents for Impulse Dynamics OPTIMIZER Smart Mini

  • Page 1 Intelio Programmer for ® OPTIMIZER Smart Mini and ® OPTIMIZER Smart Systems INSTRUCTIONS FOR USE Federal (US) law restricts this device to sale by or on the order of a physician Part No.: 13-290-020-US Rev. 01...
  • Page 2 Impulse Dynamics. The OPTIMIZER Smart Mini system and the CCM technology are protected by several U.S. Patents. For an up-to-date list of relevant patents and patent applications, visit our patents page: http://www.impulse-dynamics.com/us/patents...
  • Page 3 1.15 Storage and Handling ......................6 INTELIO PROGRAMMER SYSTEM SOFTWARE APPLICATIONS ..........6 Selector Screen ........................6 Basic Operation of the Optimizer Smart Mini Programmer Application ......7 2.2.1 Communication with the OPTIMIZER Smart Mini IPG ........... 7 2.2.2 Interrogation and Programming ................8 2.2.3...
  • Page 4 Menu Bar ......................16 3.1.7 Status Bar ......................29 Linking and Interrogation ....................30 3.2.1 Initiating a Link with the OPTIMIZER Smart Mini IPG .......... 30 3.2.2 Interrogating the OPTIMIZER Smart Mini IPG ............. 30 Modifying Parameter Values ..................... 31 3.3.1 Parameter Color Convention ................
  • Page 5 3.22.1 Summary Report ....................68 3.22.2 Parameters Report ....................69 3.22.3 Export Data ......................70 3.22.4 Database ......................70 3.23 Activity ..........................71 3.23.1 Activity Sensor Setup ................... 71 3.24 Clock Settings for the OPTIMIZER Smart Mini IPG ............72...
  • Page 6 3.24.1 Reading the OPTIMIZER Smart Mini IPG Time ........... 72 3.24.2 Setting the OPTIMIZER Smart Mini IPG Real Time Clock ........72 3.25 Standards .......................... 73 3.25.1 Saving a Standard File ..................73 3.25.2 Loading a Standard File ..................73 3.26...
  • Page 7 7.4.1 Programming the OPTIMIZER Smart IPG ............102 7.4.2 Cancel and Undo Functions ................102 Using Standards ......................103 7.5.1 Opening a Standard File..................103 7.5.2 Saving a Standard File ..................103 Loading and Exporting Information ................. 104 7.6.1 Loading Log Files ....................104 7.6.2 Exporting Data ....................
  • Page 8 7.18.1 Minimum Target Percentage for CCM Delivery..........118 7.18.2 Maximum Lead Displacement ................119 7.19 Local Sense (LS) Scan ....................119 7.20 Crosstalk Test ........................122 SOFTWARE UPDATE ......................... 123 APPENDIX I .............................. 125 Statement of FCC Compliance ..................... 125 FCC Compliance of the Intelio Programming Wand ............
  • Page 9 EXPLANATION OF SYMBOLS ON LABELS Symbol Description CE Conformity marking, 0344 - Notified Body Number 0344 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 Date of manufacture...
  • Page 10 Symbol Description Legacy Programming Wand – Power Indicator Legacy Programming Wand – Interrogate Button Legacy Programming Wand – Program Button...
  • Page 11 Smart Mini and OPTIMIZER Smart IPGs. The programmer software runs on a touch screen tablet PC with an attached Intelio Programming Interface. Note: The contents of this document pertaining to the OPTIMIZER Smart Mini IPG are also applicable to the OPTIMIZER Lite IPG.
  • Page 12 Intelio Programmer. This may create an electrical safety hazard for the patient. 1.4.1 OPTIMIZER Smart Mini IPG 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.
  • Page 13 1.5.1 Short-range Communication Short-range communication is used when the Intelio Programming Wand first establishes 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 •...
  • Page 14 User Profile and Training The operators of the Intelio Programmer system include physicians (and the trained medical personnel who assist them) and Impulse Dynamics representatives. Physicians, medical personnel, and Company representatives who operate the Intelio Programmer system should be qualified and familiar with the operation of electronic medical equipment, particularly the operation of implanted medical devices and programmers.
  • Page 15 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 removed from the patient’s implant site and placed within 1.5 m (5 ft) away from the IPG.
  • Page 16 • Data Exporting (Password-Protected): Opens the application that allows the user to export data to a USB flash drive. It is to be used by Impulse Dynamics technical staff only and is not needed for regular clinical use. •...
  • Page 17 Guardio/Vesta Charger using the Intelio Programmer, the Charger Bootstrap Cable, and a USB flash drive containing the Guardio/Vesta Charger firmware. It is to be used by Impulse Dynamics technical staff only and is not needed for regular clinical use.
  • Page 18 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 current programmed device values using the Interrogate command.
  • Page 19 Basic Operation of the Optimizer Smart Programmer Application When the Optimizer Smart button has been selected from the Selector screen, the Intelio Programmer will boot up and display the Optimizer Smart Programmer application. This application can be used to interrogate and program the OPTIMIZER Smart IPG. 2.3.1 Communication with the OPTIMIZER Smart IPG The physician can obtain data from the OPTIMIZER Smart IPG by means of the Legacy...
  • Page 20 OPTIMIZER SMART MINI PROGRAMMER SOFTWARE The Optimizer Smart Mini Programmer Software is an application 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.
  • Page 21 IEGM Sub-Pane The IEGM Sub-pane is displayed below the Surface ECG/Far-Field IEGM 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.
  • Page 22 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.
  • Page 23 3.1.1.5 Marker Screen Sweep Speed Selector To the right of the Surface ECG/Far-Field IEGM Sub-Pane is a pull-down menu that allows the user to select the sweep speed of the marker screen. Figure 10: Marker Screen Sweep Speed Selector To change the sweep speed of the marker screen, tap the field indicating the current sweep speed (located to the right of the Surface ECG/Far-Field IEGM Sub-pane) and then tap the desired sweep speed from the selection.
  • Page 24 Dark Gray: CCM is suspended • Orange: CCM is set to Continuous mode • Gray: The battery voltage of the OPTIMIZER Smart Mini IPG is low Figure 11: Legend for Marker Sub-Pane 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: •...
  • Page 25 • 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...
  • Page 26 • 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.
  • Page 27 The Stats and Trends tab has the following buttons: • CCM Statistics: Used to download and view the CCM statistics data stored in the OPTIMIZER Smart Mini IPG. • Daily Activity: Used to view the Daily Activity trends data stored in the OPTIMIZER Smart Mini IPG.
  • Page 28 CCM Settings The CCM Settings tab displays an overview of the CCM setting currently programmed into the OPTIMIZER Smart Mini IPG. This tab also has the OPTIset IEGM Sensitivities button, which allows the user to let the application analyze the patient’s heart rhythm and recommend the best sensing parameter setting for each lead.
  • Page 29 Figure 20: CCM Therapy Panel 3.1.6.2.2 Sensing The Sensing tab contains the following parameters for each lead: • Sensitivity • Polarity This tab also has the OPTIset IEGM Sensitivities button, which allows the user to let the application analyze the patient’s heart rhythm and recommend the best sensing parameter setting for each lead.
  • Page 30 LS Blanking Refractories  Pre and Post A  Pre and Post RV  Post LS This tab also has the OPTIset CCM Algorithm Timing button, which allows the user to let the application analyze the patient’s heart rhythm and recommend the best CCM timing parameters settings for the detected heart rhythm.
  • Page 31 Diagnostics Menu The Diagnostics menu contains the following tabs, each displaying a panel with diagnostic tools and settings for use in assessing the status of the implanted OPTIMIZER Smart Mini IPG. 3.1.6.3.1 Continuous Mode The Continuous Mode tab has the following buttons: •...
  • Page 32 The Battery tab displays the following battery information: • Estimated capacity: Shows the current estimated charge capacity of the battery in the OPTIMIZER Smart Mini IPG • Battery bar: Shows the current voltage of the battery in the OPTIMIZER Smart Mini IPG •...
  • Page 33 Figure 27: Special Modes Panel 3.1.6.3.5 Data Storage The Data Storage tab displays the following implant information: • Implant Date • V1 Lead Model: Model of V1 lead SN: Serial number of V1 lead • V2 Lead Model: Model of V2 lead SN: Serial number of V2 lead •...
  • Page 34 3.1.6.4 Preferences Menu The Preferences menu contains the following tabs, each with its own separate panel. 3.1.6.4.1 OPTIhome (future capability) Figure 29: OPTIhome Panel 3.1.6.4.2 Charger The Charger tab has the following buttons for Blind Charge Mode: • Set Blind Mode: Enables Blind Charge Mode Minimum Charge Time: Sets the minimum charge duration for the Guardio/Vesta Charger to charge the OPTIMIZER Smart Mini IPG...
  • Page 35 • Alerts Delivered By Charger Charger Battery Low Charger Failure Battery Low Battery Recharge Reminder  Days Long time without communication with the IPG  Days Long time without transmitting to the remote monitor  Days Minimum CCM%  Maximum lead impedance change ...
  • Page 36 Set IPG Clock: (inactive until Read IPG Clock command is executed): Manually sets the clock in the OPTIMIZER Smart Mini IPG. • Synchronize IPG clock to programmer clock: Automatically sets the clock in the OPTIMIZER Smart Mini IPG to the current date and time of the Intelio Programmer.
  • Page 37 Figure 35: Remote Panel 3.1.6.5.2 Standards The Standards tab has the following buttons: • Load Program: Loads the saved standard file onto the Optimizer Smart Mini Programmer application. • Save Program: Saves the current parameter values as a standard file.
  • Page 38 The Engineering tab has the following buttons that are enabled only after entering the correct passcode. • Update Implantable Device: Updates the firmware of the OPTIMIZER Smart Mini IPG using a bootloader file loaded from a separate USB flash drive. • Get Device Log: Downloads the device log from the OPTIMIZER Smart Mini IPG.
  • Page 39 Version: Firmware version of Intelio Programming Wand Figure 39: About Panel 3.1.7 Status Bar The Status Bar displays the Impulse Dynamics logo along with the tablet PC’s battery charge percentage and the following information: • Restrictions and Warnings (becomes active when a parameter conflict, restriction, or warning is present –...
  • Page 40 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 removed from its position directly over the implant site and placed within 1.5 m (5 ft) away from the IPG.
  • Page 41 (for instance, if the device mode of the OPTIMIZER Smart Mini IPG is set to ODO-LS-CCM, only then are the parameters settings associated with atrial events displayed). As such, when a parameter setting is meaningless in the context of other parameter settings, it is not displayed by the programmer application.
  • Page 42 When a parameter conflict occurs, the parameter values that are in conflict are all 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.
  • Page 43 Optimizer Smart Mini Programmer application screens are all shown in black, since they are the parameter values currently programmed into the OPTIMIZER Smart Mini IPG. If an OPTIMIZER Smart Mini IPG is not linked with the programmer and parameter data were loaded from a standard (.mips file), the parameter values displayed are the values stored in the standard file.
  • Page 44 OFF: Disables CCM therapy delivery b. 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 (see Section 3.7).
  • Page 45 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 parameter settings associated with atrial events are no longer active. In addition, limitations are placed on certain parameters in order to ensure that CCM therapy is delivered appropriately.
  • Page 46 5 hs/day. To access the CCM hs/day parameters: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 47 Below the Start Time and End Time parameters are the On Time and Off Time intervals. The On Time is the interval when the OPTIMIZER Smart Mini IPG is scheduled to deliver CCM therapy. It always has the value 01 h : 00 m. The Off Time is the period of time between each one-hour On Time interval when the OPTIMIZER Smart Mini IPG is not scheduled to deliver CCM therapy.
  • Page 48 (3 seconds) and then removing it from the implant site sets the OPTIMIZER Smart Mini IPG into CCM Magnet Mode (indicated by a yellow bar in CCM Status row of the Marker Sub-pane), suspending CCM therapy.
  • Page 49 To use the OPTIset IEGM Sensitivities tool: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b. Tap the Start OPTIlink button on the OPTIlink Session Pane 2.
  • Page 50 Figure 44: OPTIset: IEGM SENSITIVITIES Window When the OPTIset: CCM ALGORITHM TIMING window appears, the analysis will begin automatically. When the analysis is done, the buttons at the bottom right of the screen will become enabled (turn blue). 10. Tap the Propose button If the analysis was successful, a green checkmark will be shown along with a message indicating that the OPTIset proposal of CCM algorithm timing is complete.
  • Page 51 Figure 45: OPTIset: CCM ALGORITHM TIMING Window 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.
  • Page 52 Figure 46: OPTIset: CCM AMPLITUDE Window 14. When the Optimizer Smart Mini Programmer application returns to its main application screen, tap the blinking Program button on the Programming Buttons Pane to load the OPTIMIZER Smart Mini IPG with the new parameter settings.
  • Page 53 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. •...
  • Page 54 • Pre A: Sets the time interval before an atrial event when signals falsely identified as LS events are masked from detection. Note: This parameter is active only when the OPTIMIZER Smart Mini IPG is in ODO-LS-CCM mode. • Post A: Sets the time interval after an atrial event when signals falsely identified as LS events are masked from detection.
  • Page 55 Note: If a patient expresses discomfort when the OPTIMIZER Smart Mini IPG is delivering CCM therapy, setting the first phase polarity to “Negative” may help alleviate this discomfort. • Phase Duration: Sets the width of each CCM therapy pulse phase.
  • Page 56 3.14 Lead Impedance Measurements The OPTIMIZER Smart Mini IPG measures the impedance of the ventricular leads by sending of a biphasic pulse through each ventricular lead with the following characteristics: • Amplitude: 4.5 V ± 10% • Phase Duration: 0.5 ms ± 0.031 ms •...
  • Page 57 The following are the list of tabs for the CCM Statistics and the statistics that are shown under each tab: • On - General: Events occurring when the OPTIMIZER Smart Mini IPG is scheduled to deliver CCM therapy (On Time). Events ...
  • Page 58 CCM delivery. • Off - General: Events occurring when the OPTIMIZER Smart Mini IPG is not scheduled to deliver CCM therapy (Off Time). Displays the same list of CCM statistical counters as detailed under On - General (except for Trains Delivered).
  • Page 59 3.15.1.4 Resetting CCM Statistics Counters To reset the OPTIMIZER Smart Mini IPG CCM Statistics counters to zero: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 60 3.15.2 Daily Activity Trends 3.15.2.1 Viewing Daily Activity Trends To view the Daily Activity trends stored by the OPTIMIZER Smart Mini IPG: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 61 3.15.3 Activity Per Hour Trends 3.15.3.1 Viewing Activity Per Hour Trends To view the Activity Per Hour trends stored by the OPTIMIZER Smart Mini IPG: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 62 • Position: Displays what percentage of time the patient was in each position each hour. • Average HRV (ms): Displays average hourly heart rate variability (HRV). Note: Tap on a specific data point on one of the graphs to view the numerical data for that hour.
  • Page 63 3.15.4 Battery Trends 3.15.4.1 Viewing Battery Trends To view the Battery trends stored by the OPTIMIZER Smart Mini IPG: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 64 3.15.5 Lead Trends 3.15.5.1 Viewing Lead Trends To view the Lead trends stored by the OPTIMIZER Smart Mini IPG: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 65 • V2 Lead SN: Displays the serial number of the V2 lead. Note: The serial number shown is dependent on the V2 lead information entered on the Implant Data screen (see section 3.18.1). V1 Ω: Displays the weekly measured impedance value for the V1 lead. •...
  • Page 66 3.15.6 Alerts Trend 3.15.6.1 Viewing Alerts Trend To view the Alerts trends stored by the OPTIMIZER Smart Mini IPG: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 67 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.
  • Page 68 Special Modes tab. 3.17.1 Medical Procedure The Medical Procedure mode allows the user to turn OFF the OPTIMIZER Smart Mini IPG’s CCM functions for patients scheduled to undergo a medical procedure that will subject them to an environment that may adversely affect the functionality of their implanted device.
  • Page 69 3.17.2 OPTIMIZER Smart Mini IPG Reset If an OPTIMIZER Smart Mini IPG is in Safe Mode, it can be reset using the IPG Reset feature of the Optimizer Smart Mini Programmer application under physician supervision. To reset the OPTIMIZER Smart Mini IPG: 1.
  • Page 70 3.18.2.1 Accelerometer The Accelerometer setting controls the use of the built-in accelerometer in the OPTIMIZER Smart Mini IPG to collect information about the patient’s level of activity with regards to movement (e.g., stationary vs. walking or running). To set the Accelerometer: 1.
  • Page 71 When the OPTIMIZER Smart Mini IPG is used for a blinded clinical investigation, the study protocol may stipulate that the OPTIMIZER Smart Mini IPG implanted in one group of patients be programmed not to deliver CCM therapy. Since the battery discharge rate of an OPTIMIZER...
  • Page 72 Note: The Temperature Charge Constants do not typically require modification and should only be changed by or at the direction of a physician. To ensure patient safety while charging the OPTIMIZER Smart Mini IPG, the temperature of the IPG is monitored during the charging process. The temperature limits used by the OPTIMIZER Smart Mini IPG when monitoring its temperature are referred to as the Temperature Charge Constants.
  • Page 73 • Never: Audible tones are never emitted by the Guardio/Vesta Charger when it displays a Patient Alert received from the OPTIMIZER Smart Mini • Always: Audible tones are always emitted by the Guardio/Vesta Charger when it displays a Patient Alert received from the OPTIMIZER Smart Mini •...
  • Page 74 5. Tap 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 Low Alert The Battery Low alert is triggered whenever the OPTIMIZER Smart Mini IPG’s battery voltage drops to 3.5 V. To set the Battery Low alert: 1.
  • Page 75 3.21.6 Long Time Without Communication With The IPG Alert The Guardio/Vesta Charger keeps a record of the communication events with the OPTIMIZER Smart Mini IPG. This record is used to determine the number of days since its last successful communication event with the OPTIMIZER Smart Mini IPG.
  • Page 76 3.21.8 Minimum CCM% Alert The OPTIMIZER Smart Mini IPG maintains a record of sensed events and CCM trains delivered during each scheduled CCM delivery period. This record is used to determine the percentage of CCM therapy pulses delivered during this period.
  • Page 77 The CCM Not Sensing/Noise alert is triggered if either one of the following conditions occurs: • 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 noise detected in 1 day (minimum of 30 minutes of...
  • Page 78 3.21.12 CCM Safe Mode Alert The CCM Safe Mode alert is triggered whenever the OPTIMIZER Smart Mini IPG has been placed into Safe Mode for any reason. To set the CCM Safe Mode alert: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a.
  • Page 79 The Parameters Report is a printout of the current parameter settings programmed into the OPTIMIZER Smart Mini IPG. To create a Parameters Report: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 80 3.22.3 Export Data The Optimizer Smart Mini Programmer application features the ability to Export Statistics in the form of a CSV file. To Export Statistics: 1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG a. Place (or replace, if necessary) the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG implant site b.
  • Page 81 3.23 Activity 3.23.1 Activity Sensor Setup The OPTIMIZER Smart Mini IPG includes a built-in accelerometer, which it utilizes as an “Activity Sensor”, allowing it to monitor the activity level of the patient. To complete the initial setup of the Activity Sensor: 1.
  • Page 82 3.24 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 operations: • The delivery of CCM therapy in accordance with the programmed CCM therapy scheduling parameters •...
  • Page 83 (also known as user presets) file on the Intelio Programmer. Then when needed, this saved standard file can be loaded onto the Optimizer Smart Mini Programmer application and then programmed into an OPTIMIZER Smart Mini IPG.
  • Page 84 Hotline (866-312-5370). 3.27.1 CCM Log Download The OPTIMIZER Smart Mini IPG keeps a log of any internal events that may occur as well programming and charging events that occur when interacting with the programmer application or Guardio/Vesta Charger, respectively. This CCM log can be downloaded from the OPTIMIZER Smart Mini IPG using the Optimizer Smart Mini Programmer application.
  • Page 85 To export files: 1. On the left-hand side of the Intelio Programmer tablet PC, push the flap covering the USB ports towards the back of the tablet PC to unlock it and then fold the flap outwards. 2. Insert a USB flash drive into one of the two USB ports on the Intelio Programmer tablet PC. 3.
  • Page 86 REMOTE OPERATION Connecting the Intelio Programmer to a Wi-Fi Network Before any remote operation is initiated, the Intelio Programmer must first be connected to a Wi- Fi network. This is accomplished by using the Network Configuration Utility. To connect the Intelio Programmer to a Wi-Fi network: 1.
  • Page 87 4. Enter the Wi-Fi password and then tap OK. See Figure 62. Figure 62: Wi-Fi Password Entry 5. The selected Wi-Fi network should no longer be grayed out, the button next to it should say “Disconnect”, and the Wi-Fi strength indicator should now be illuminated light blue. See Figure 63.
  • Page 88 The Remote session feature of the Optimizer Smart Mini Programmer application allows for remote programming the OPTIMIZER Smart Mini IPG. Warning: Remote Programming of the OPTIMIZER Smart Mini IPG requires a clinician to be present and in constant observation of the patient. Furthermore, the clinician and the remote operator MUST be in constant telephonic communication throughout the complete remote programming session.
  • Page 89 Optimizer Smart Mini Programmer application of a local programmer. This is accomplished using the remote access tool. Warning: Remote Programming of the OPTIMIZER Smart Mini IPG requires a clinician to be present and in constant observation of the patient. Furthermore, the clinician and the remote operator MUST be in constant telephonic communication throughout the complete remote programming session.
  • Page 90 GUARDIO/VESTA CHARGER FIRMWARE UPDATE The Intelio Programmer includes an application that allows a user to update the firmware installed on a Guardio/Vesta Charger. To update the Guardio/Vesta Charger firmware: 1. On the left-hand side of the Intelio Programmer tablet PC, push the flap covering the USB ports towards the back of the tablet PC to unlock it and then fold the flap outwards.
  • Page 91 Impulse Dynamics and then tap OK. 10. When the second Password pop-up window appears, enter the appropriate password obtained from Impulse Dynamics and then tap OK. 11. Enter the serial number of the Guardio/Vesta Charger in the Serial# field. See Figure 68.
  • Page 92 14. Verify that the application has begun loading the GUI firmware on the Guardio/Vesta Charger. See Figure 70. Figure 70: Bootstraploader Screen Indicating GUI Firmware Upload has Begun 15. When the firmware update has been completed, verify that the application displays a message “The firmware has been successfully downloaded to the device”.
  • Page 93 17. Hold and pull back on the metal sleeve of the Bootstrap Loader cable connector to disconnect it from the Guardio/Vesta Charger. See Figure 72. Connector Sleeve pulled Connector Sleeve Figure 72: Close-up of the Connector Sleeve 18. Replace the protective cover flap over the input connector of the Guardio/Vesta Charger. 19.
  • Page 94 Figure 73: Optimizer Smart Programmer Application Main Screen 7.1.1 Title Bar The Title Bar is displayed at the top of the window. It identifies the software currently running, and the source of the data, which can be either of the following: •...
  • Page 95 The trace and color references are shown in the Marker Reference Bar. Figure 75: Marker Reference Bar 7.1.3 View Bar The View Bar contains the buttons for following commands: • Marker view: displays the Marker window in Marker view • Graph view: displays the Marker window in Graph view •...
  • Page 96 Inactive: this label appears at the top left of the Marker window as long as the CCM delivery is not Active. The background color of the Marker window is white in this case. Active-On: this label appears at the top left of the Marker window as long as the CCM delivery is Active and On.
  • Page 97 • LS Refractory periods are displayed as light blue rectangles of the corresponding width with a dotted line edge. • LS Alert Window is displayed as a light yellow rectangle of the corresponding width with a dotted line edge. • The CCM Pulse Train is displayed as a square wave.
  • Page 98 7.1.3.3 LS Wizard In the LS Wizard the ECG is not displayed, only the LS parameter values are shown and can be modified. To modify a parameter value, drag it with the cursor inside the graph to the desired position (the numeric value of the parameter is shown as you point to it or move it).
  • Page 99 • Reset: Resets the OPTIMIZER Smart IPG. This command should be used only if the Optimizer Smart Programmer application reports that the OPTIMIZER Smart IPG being interrogated is in the “DOWN” mode [Standby (OOO), no CCM reversion mode]. • Marker: Sets the OPTIMIZER Smart IPG in Marker Mode (i.e., Marker Events are displayed in the Marker Window for every sensed and generated event.
  • Page 100 7.1.6 Device Bar The Device Bar displays the device model, serial number, current cardiac contractility modulation therapy status, and current battery level of the interrogated device. Figure 81: Device Bar 7.1.7 Log Bar A special file in the Optimizer Smart Programmer application contains a record (log) of all the interactions between the OPTIMIZER Smart IPG and the Intelio Programmer, including the date and time when these interactions occurred.
  • Page 101 Figure 83: Programming Bar 7.1.9 Parameter Conflict Bar In the bar under the Programming Bar, parameter conflict messages are displayed. These messages indicate which parameter values are in conflict, why the parameters are in conflict and the name of the parameter tab in which the conflicting parameters appear. By tapping on an error message, a list of the parameters that are in conflict appears.
  • Page 102 7.1.10.1 Follow Up Menu The Follow Up menu contains the following tabs, each displaying a panel containing information about the current status of the OPTIMIZER Smart IPG. 7.1.10.1.1 Current Status The Current Status tab displays the following information: • CCM % Last 24h: CCM % in the last 24 hours Total: CCM % since last statistics reset Reset: Date of last statistics reset...
  • Page 103 7.1.10.1.2 Sensing The Sensing tab contains the following parameters for the Atrial and Ventricle (RV) leads: • Sensitivity This tab also has the atrium and ventricle sensing threshold buttons which allows the user to measure the atrium and ventricle (RV) sensing thresholds.
  • Page 104 7.1.10.1.4 LS Setup The LS Setup tab contains the following parameters for the RV and LS leads: • LS Sensitivity • LS Refractories for artificial blanking Pre and Post V Post LS • Alert Start to V • Alert Width •...
  • Page 105 Figure 91: Crosstalk Test Panel 7.1.10.2 Parameters Menu The Parameters menu contains the following tabs, each displaying a panel with parameters that can be set for the OPTIMIZER Smart IPG: 7.1.10.2.1 Overview The Overview tab contains the most important parameters found under the A/V, LS, and CCM Train &...
  • Page 106 Figure 93: A/V Panel 7.1.10.2.3 LS The LS tab contains the following parameters: • LS Alert Sensing Window LS Sensitivity LS Alert Start to V Alert Width Post LS Refractory LS-CCM Delay • LS Blanking Refractories Pre and Post V Post LS Figure 94: LS Panel 7.1.10.2.4 CCM Train &...
  • Page 107 Amplitude Channels   Figure 95: CCM Train & Schedule 7.1.10.2.5 Alarms The Alarm tab contains the following parameters related to the alarms to be reported to the charger: • Minimum Target % for CCM Delivery • Maximum Lead Displacement Figure 96: Alarms Tab 7.1.10.2.6 Settings The Settings tab has the following buttons:...
  • Page 108 Figure 97: Settings Tab 7.1.11 Statistics Menu The Statistics menu contains the following tabs, each with their own panel: • On - General: displays the number of sensed events, periods, and trains during scheduled CCM delivery. • On - Inhibition: displays the number of sensed events that inhibited CCM during scheduled CCM delivery.
  • Page 109 Figure 99: Statistics On - General Panel (Graph View) 7.1.12 Log Files When the Log Files button is selected, the programming commands on the Main Tool Bar are changed to the following Log File commands: • Browse: opens the Marker window for viewing. •...
  • Page 110 7.2.2 Interrogating the OPTIMIZER Smart IPG To read the parameter values of the OPTIMIZER Smart IPG: 1. Place (or replace, if necessary) the Legacy Programming Wand over the OPTIMIZER Smart IPG implant site. 2. Perform one of the following actions: a.
  • Page 111 To modify a parameter value: 1. Select the tab where the parameter to be modified appears. 2. Tap the parameter value to be modified. A window with all of its possible values will appear. 3. Select the new value from the list. This value will become the new parameter value. 4.
  • Page 112 Conflicting parameters can also be found directly under the Follow Up or Parameters menus, since these values appear in red. Look for the names of the conflict related tabs in the parameter conflict message displayed in the Parameter Conflict Bar. Please note that it is permissible to select a parameter that causes a conflict provided that another parameter value is changed that resolves the conflict.
  • Page 113 Please note that after executing a Cancel command, the parameter values in the Optimizer Smart Programmer application screens become black, since they are the same as the parameter values in the OPTIMIZER Smart IPG. If no device was interrogated and parameter data were loaded from a .tip file, the displayed parameter values are the values stored in the standard (.tip file).
  • Page 114 2. A Save As window will pop up. Enter the file name of the standard to be saved and then tap Save. Loading and Exporting Information 7.6.1 Loading Log Files To load a Log file: 1. Tap the Log Files button on the Menu Bar 2.
  • Page 115 7.7.2 ECG Recording To record a patient’s ECG: 1. Tap the Log Files button on the Menu Bar 2. Tap the Recording button on the Tool Bar The same procedure must be used to stop recording the ECG. When the OPTIMIZER Smart IPG is set to Marker Mode, the ECG starts recording automatically.
  • Page 116 7.10 Resetting the OPTIMIZER Smart IPG The OPTIMIZER Smart 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 IPG will place itself into a safe state referred to as “DOWN”...
  • Page 117 The Operating Mode choices are: • Standby (OOO): The device is placed in safe mode with no CCM therapy delivery. • Active ODO-LS-CCM: The device uses atrial, ventricular, and local sense events as triggers for CCM therapy delivery. • Active OVO-LS-CCM: The device uses only ventricular and local sense events as triggers for CCM therapy delivery.
  • Page 118 Figure 104: Continuous CCM Delivery Warning To program the CCM Mode into the OPTIMIZER Smart IPG: 1. Place (or replace, if necessary) the Legacy Programming Wand over the OPTIMIZER Smart IPG implant site. 2. Tap the CCM Mode parameter on the Device Bar. 3.
  • Page 119 7.12.2 Turning Markers Off To turn off Marker Mode: 1. Tap the Marker button the Tool Bar, or 2. Remove the Legacy Programming Wand from the implant zone. If the Legacy Programming Wand cannot communicate with the OPTIMIZER Smart IPG, the Marker Mode is automatically terminated.
  • Page 120 7.12.7 Log Browser Window When the Log Files button from the Menu Bar is selected and then the Browse button is selected from the Tool Bar, the corresponding window titled Marker Window is displayed. Figure 105: Marker Window For the OPTIMIZER Smart IPG the log browser window is composed of the following elements: •...
  • Page 121 The upper left half of this tab is the parameter Scheduled. The Scheduled parameter sets the total number of hours per day the OPTIMIZER Smart IPG is scheduled to deliver cardiac contractility modulation therapy within the time frame set by the Start time and End time. This parameter is calculated depending on settings for On Time and Off time.
  • Page 122 • The minimum LS sensitivity setting is limited to 1.0 mV • The maximum LS Alert Window Width is limited to 30 ms • The maximum LS-CCM Delay is limited to 45 ms Figure 107: Sensing Panel in Active OVO-LS-CCM Mode Figure 108: AV Setup Panel in Active OVO-LS-CCM Mode Figure 109: Overview Panel in Active OVO-LS-CCM Mode Figure 110: A/V Panel in Active OVO-LS-CCM Mode...
  • Page 123 7.15 Measuring Lead Impedances The impedance of the LS and V leads can be measured by the OPTIMIZER Smart IPG and displayed by the Optimizer Smart Programmer application. A CCM therapy pulse is delivered through the selected channel by the OPTIMIZER Smart IPG in order to measure the lead impedance.
  • Page 124 7.16.1 Loading Statistics To obtain the Statistics from the OPTIMIZER Smart IPG: 1. Place (or replace, if necessary) the Legacy Programming Wand over the OPTIMIZER Smart IPG implant site. 2. Tap the Statistics button on the Menu Bar. 3. Tap the Read button at the bottom of the Statistics panel. If the loading is successful, the Programmer will display the message “Read Statistics OK”.
  • Page 125  Short AV: number of times Short AV condition detected during scheduled CCM delivery  LS: number of Local Sense events outside the LS Alert Window during scheduled CCM delivery  LS Absence: number of Local Sense events not detected during scheduled CCM delivery ...
  • Page 126 7.17 Setting the Clocks on the OPTIMIZER Smart IPG and Intelio Programmer The time of day is maintained by an internal clock within the OPTIMIZER Smart IPG and is used by the cardiac contractility modulation Therapy Delivery Scheduling mechanism to turn the CCM therapy ON and OFF in accordance with the programmed CCM Schedule parameters.
  • Page 127 1. Select the new time in the Device current time box. The Set Time button will start to blink, indicating that the current device time is different from the one displayed on the screen. 2. Tap the Set Time button. Caution: Be certain that you are selecting the correct button.
  • Page 128 Figure 112: Set system time Window 7.18 OPTIMIZER Smart IPG Alarms Reported to the OPTIMIZER Mini Charger 7.18.1 Minimum Target Percentage for CCM Delivery The OPTIMIZER Smart IPG keeps a record of the events and conditions that occurred during the last Active Period of the CCM scheduled delivery. This record can be used to calculate the percentage of CCM therapy delivered compared to the number of right ventricular events sensed during the period.
  • Page 129 7.18.2 Maximum Lead Displacement Possible damage or displacement of a ventricular lead could be identified by a change in the lead impedance compared to previous measured values. Measurement of V and LS lead impedances by either the Optimizer Smart Programmer application or OPTIMIZER Mini Charger are stored in the OPTIMIZER Smart IPG.
  • Page 130 Figure 113: LS Scan Screen When running an LS Scan, the OPTIMIZER Smart IPG is set to a special mode in which LS signals are sampled every 2 ms throughout a 200 ms interval centered at the right-ventricular event. These signals are sent to the Intelio Programmer to be displayed in the Local Sense Scan window as histograms.
  • Page 131 Figure 114: Local Sense Scan Screen after Automatic Scan To use the results of the LS Scan: 1. Tap the check box next to the desired sensitivity values. 2. Tap the Go to LS Setup button. 3. Once the application returns to the LS Setup panel, select the check box under LS 1 column of the Measurement box.
  • Page 132 Figure 115: LS Setup Screen after Selection of Propose LS Button 7.20 Crosstalk Test The Optimizer Smart Programmer application has a Crosstalk Test tool which may be used whenever device/device interaction testing (see Appendix III) is performed between the OPTIMIZER Smart IPG and an implanted concomitant device. To start the Crosstalk Test: 1.
  • Page 133 3. When the Password pop-up window appears, enter the appropriate password obtained from Impulse Dynamics and then tap OK. 4. When the Install Updates pop-up window appears, enter the updates password obtained from Impulse Dynamics and then tap Install Updates. See Figure 116. Figure 116: Install Updates Window...
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  • Page 135 APPENDIX I Statement of FCC Compliance FCC Compliance of the Intelio Programming Wand The Intelio Programming Wand has been tested to the following FCC rules: • 47 CFR Part 15 – Radio Frequency Devices • 47 CFR Part 95 Subpart I - Medical Device Radio Communications Service This device complies with part 15 of the FCC Rules.
  • Page 136 GUIDELINES AND MANUFACTURER’S 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.
  • Page 137 Power line 30 A/m 30 A/m Power line frequency magnetic frequency fields (50/60 Hz) should be at magnetic fields levels expected in a typical (50/60 Hz) as professional healthcare or hospital defined in environment. IEC 61000-4-8 Conducted RF 3 V r.m.s outside 3 V r.m.s outside Portable and mobile RF as defined in...
  • Page 138 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Intelio Programmer Recommended separation distances between portable and mobile RF communications equipment and the Intelio Programmer The Intelio Programmer should be used in an electromagnetic environment with limited radiated RF noise.
  • Page 139 FCC 47 CFR Part 15 – Radio Frequency Devices 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.
  • Page 140 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.
  • Page 141 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.
  • Page 142 – 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.
  • Page 143 FCC 47 CFR Part 15 – Radio Frequency Devices 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.
  • Page 144 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.
  • Page 145 – 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.
  • Page 146 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, 402–405 MHz) of the MedRadio Band.
  • Page 147 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: •...
  • Page 148 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 IPG’s plane and its center is coaxial with the center of the IPG’s header.
  • Page 149 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.

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