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Impulse Dynamics OMNI II Instructions For Use Manual

Programmer system (with omni smart software) and mini charger
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OMNI II Programmer (with
OMNI Smart Software)
System and OPTIMIZER
Mini Charger
INSTRUCTIONS FOR USE
Part No.: 13-290-009-EU Rev. 4

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Summary of Contents for Impulse Dynamics OMNI II

  • Page 1 OMNI II Programmer (with OMNI Smart Software) System and OPTIMIZER Mini Charger INSTRUCTIONS FOR USE Part No.: 13-290-009-EU Rev. 4...
  • Page 2 OMNI™ is a trademark property of Impulse Dynamics. CCM™ is a trademark of Impulse Dynamics. The OMNI II Programmer (with OMNI Smart Software) and OPTIMIZER Mini 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.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS EXPLANATION OF SYMBOLS ON LABELS ....................... I OVERVIEW OF THE OMNI II PROGRAMMER (WITH OMNI SMART SOFTWARE) SYSTEM ..1 Description ..............................1 Programmer Functions ..........................2 Programmer Components .......................... 2 Interconnecting the Programmer Components for Operation ..............3 Programmer Wand.............................
  • Page 4 3.1.4 Programming Bar .........................21 3.1.5 Log Bar ............................22 3.1.6 ECG Window ..........................23 3.1.7 Statistics Bar ..........................24 3.1.8 Status Bar .............................25 Graphic View ............................26 3.2.1 Dynamic View..........................27 3.2.2 Static View ...........................28 Interrogation ............................28 3.3.1 Communicating with the Implanted OPTIMIZER IVs IPG ............28 3.3.2 Interrogating the OPTIMIZER IVs IPG ..................29 Modifying Parameter Values ........................29 3.4.1 Parameter Color Convention ......................30...
  • Page 5 3.19 Local Sense (LS) Diagnostics........................51 3.20 Remote Operation ............................ 53 3.20.1 Connecting the OMNI II Programmer to a Wired Ethernet Network .......... 53 3.20.2 Connecting the OMNI II Programmer to a Wireless Network ............. 53 3.20.3 OMNI II Operation Modes......................56 3.20.4 OMNI II Programmer Client Window ..................
  • Page 6 4.2.1 Communicating with the Implanted OPTIMIZER Smart IPG .............79 4.2.2 Interrogating the OPTIMIZER Smart IPG ...................79 Modifying Parameter Values ........................79 4.3.1 Parameter Color Convention ......................80 4.3.2 Parameter Conflicts ........................80 Programming ............................81 4.4.1 Programming the OPTIMIZER Smart IPG ..................81 4.4.2 Cancel and Undo Functions ......................82 Using Standards ............................83 4.5.1 Opening a Standard File .......................83 4.5.2 Saving a Standard File ........................83...
  • Page 7 4.21.2 Connecting the OMNI Smart Programmer to a Wireless Network ..........106 4.21.3 OMNI Smart Operation Modes ....................108 4.21.4 OMNI II Programmer Client Window ..................110 4.21.5 Starting a Remote Session with the OMNI Smart Programmer ..........111 4.21.6 Ending an OMNI Smart Programmer Remote Session .............. 113 4.21.7 Sending a Chat Message Using the OMNI Smart Programmer ..........
  • Page 8 7.6.4 Numerical Code 3 ........................122 7.6.5 Numerical Code 4 ........................122 7.6.6 Numerical Code 5 ........................123 7.6.7 Numerical Code 6 ........................123 7.6.8 Numerical Code 7 ........................123 7.6.9 Numerical Code 8 ........................123 Cleaning ..............................123 Maintenance ............................124 Storage and Handling ..........................124 7.10 Disposal ..............................124 APPENDIX I ................................

  • Page 9: Explanation Of Symbols On Labels

    EXPLANATION OF SYMBOLS ON LABELS SYMBOL DESCRIPTION Manufacturer Date of Manufacture Conformité Européenne 0344 = Notified Body 0344 Number for AIMDD Consult instructions for use. Caution, consult accompanying documents European Representative Transport Temperature Limits Part Number Serial Number Do Not Use if Package is Damaged Class II Type BF Applied Part...
  • Page 10 Programming Interrogation Wand Signal Strength Indicator DC Power Input (charger connection) Serial data I/O port (for use only by Impulse Dynamics technical personnel) IPG-Charger Coupling Signal Strength Indicator ”Call Doctor” Indicator Charger Start Button Battery Status Indicator OPTIMIZER Mini Charger...
  • Page 11 SYMBOL DESCRIPTION OPTIMIZER Smart IPG...
  • Page 12 THIS PAGE INTENTIONALLY LEFT BLANK...

  • Page 13: Overview Of The Omni Ii Programmer (With Omni Smart Software) System

    Programmer Wand communicates via magnetic induction telemetry with the IPG implanted in the patient. Understanding the instructions contained in this manual on how to operate the OMNI II Programmer (with OMNI Smart Software) System is essential to proper operation of both the OPTIMIZER Smart IPG and OPTIMIZER IVs IPG.

  • Page 14: Programmer Functions

    • CE marked Power Cord • Bluetooth printer with AC Adapter Warning: Use of items other than those identified above or in a manner not in accord with these instructions may cause damage to the OMNI II Programmer (with OMNI Smart Software).

  • Page 15: Interconnecting The Programmer Components For Operation

    -type connector) into the port labeled USB on the back panel of the Programmer Interface Box. • Plug the OMNI II Programmer Wand cable connector into port labeled WAND on the back panel of the Programmer Interface Box. Note: If required, the Wand Extension cable may be used to extend the reach of the Programmer Wand.

  • Page 16: Charging The Battery Of The Omni Ii Programmer Tablet Pc

    240VAC, 50/60Hz and that the receptacle has a properly grounded connection. • When the charging the battery of the OMNI II Programmer Tablet PC, allow the internal battery to charge for a full 24 hours before attempting to use the OMNI Smart Programmer at implant.

  • Page 17: Using The Omni Ii Programmer Tablet Pc Touch Screen

    Figure 4: Example of Buttons and Illuminated Symbols on OMNI II Programmer Tablet 1.10 OMNI II Programmer Tablet PC Battery Replacement The OMNI II Programmer Tablet PC is powered by a battery that may need to be replaced if it fails to properly recharge. Contact your local Impulse Dynamics representative if a replacement battery is needed.

  • Page 18: Storage And Handling

    (with OMNI Smart Software) System is not protected against ingress of water or humidity (ingress protection rating IPX0). Warning: Always turn the OMNI II Programmer (with OMNI Smart Software) off prior to cleaning. Following each use, it is recommended that a soft cloth dampened with a germicidal cleaning solution be used to wipe the exterior case of the programmer, the ECG cables and, particularly the Programmer Wand.

  • Page 19: Applications

    OPTIMIZER Smart IPG and OPTIMIZER IVs IPG. Selection Screen When the OMNI II Programmer (with OMNI Smart Software) is turned on, a selection screen is presented upon completion of the start-up sequence. Click on the appropriate button for the desired operation.

  • Page 20: Omni Smart

    OFF the OMNI Smart Programmer. Basic Operation of the OMNI II Programmer Application After the Clinical Mode button has been selected from the OMNI II box on the Selector screen, the OMNI II Programmer application’s main screen is displayed.

  • Page 21: Interrogation And Programming

    The Open and Save commands of the OMNI II Programmer read and write data from and to .tip files. As such, the OMNI II Programmer Software can also be used as an editor of standards (see Section 3.6).

  • Page 22: Basic Operation Of The Omni Smart Programmer Application

    OPTIMIZER IVs IPG are displayed in the patient’s ECG window synchronized with the patient’s ECG signal. • The OMNI II Programmer System keeps a Log of all the interactions that take place with the OPTIMIZER IVs IPG.

  • Page 23: Monitoring Tools

    If the new parameter values do not yield the desired clinical effect, they can be cancelled using the Undo command. This command resets the device parameters to those previously programmed. The Urgent command programs the OPTIMIZER Smart IPG with standard safe parameter values (CCM OFF).

  • Page 24: Omni Ii Programmer Software

    OMNI II PROGRAMMER SOFTWARE The OMNI II Programmer Software is an application that is used to read and modify the parameters that control the OPTIMIZER IVs IPG. This section describes the various OMNI II Programmer System screens. The OMNI II Programmer Main Screen...

  • Page 25: Menu Bar

    • Info: contains commands used to display information about the OPTIMIZER IVs IPG and the OMNI II Programmer Software version, as well as Interface Battery information, and a Help command. Select the tab to display the list of options/commands under each tab.
  • Page 26 Restore Restores session data from removable flash drive. Print preview Shows a preview of a list of the current OMNI II Programmer values to be printed. Print current The list of the current OMNI II Programmer values is sent to the default standard…...
  • Page 27 OPTIMIZER IVs IPG to measure the RV and LS lead impedances. Reset Device Resets the OPTIMIZER IVs device. This command should be used only if the OMNI II Programmer reports that the OPTIMIZER IVs IPG being interrogated is in the “DOWN” mode (safe OOO, no CCM™ reversion mode).
  • Page 28 Opens Chat message window, which allows the user to exchange chat messages with the remote pair. Master Puts the OMNI II Programmer in Master mode, which allows the user to control the device. Slave Puts the OMNI II Programmer in Slave mode and allows the Remote user to control the local programmer.
  • Page 29 Description IPG Version Displays the firmware version of the interrogated IPG. Interface battery Reads the Battery Voltage of the lithium battery inside the OMNI II Programmer Interface Box. Interface version Displays the firmware version of the OMNI II Programmer Interface Box.

  • Page 30: Parameter Tabs

    3.1.3 Parameter Tabs The set of parameters of the OPTIMIZER IVs IPG are displayed by six Parameter screens placed under six tabs. Each one of these screens displays a different set of parameter values, grouped by the following tabs: • A/V: displays the serial number and battery voltage of the interrogated device, the operating mode, as well as the atrial and ventricular heart sensing and timing parameters.
  • Page 31 Figure 8: CCM™ Train Parameter Tab Figure 9: CCM™ Inhibit Parameter Tab Figure 10: LS Parameter Tab...
  • Page 32 Figure 11: CCM™ Schedule Parameter Tab Figure 12: Charger Parameter Tab Parameter values are displayed in two different ways: • For enabling/disabling parameters (such as CCM™ Channels), checkboxes are used, and a  symbol indicates that the option is selected. To change the option, select the box to the left of the parameter name.

  • Page 33: Programming Bar

    When such situations arise, an error message is displayed in the Programming Bar (See Section 3.1.4 for more information). As long as there is a parameter conflict, the OMNI II Programmer will not allow the OPTIMIZER IVs IPG to be programmed with new parameter values. This ensures that only compatible parameter configurations can be downloaded to the OPTIMIZER IVs IPG.

  • Page 34: Log Bar

    Figure 14: Example of Parameter Conflict Message 3.1.5 Log Bar A special file in the OMNI II Programmer Software contains a record (log) of all the interactions between the OPTIMIZER IVs IPG and the OMNI II Programmer, including the date and time when these interactions occurred.

  • Page 35: Ecg Window

    • If an Interrogation or Programming event is chosen, the parameter values displayed by the OMNI II Programmer are the set of values present at the moment the selected event occurred. • If an event involving Statistics (clear/load/reset) is chosen, the Statistics Bar values are set to the values present at the moment the selected event occurred.

  • Page 36: Statistics Bar

    • CCM™ signal delivery is represented by a marker in the shape of a blue rectangle above the baseline whose length represents the duration of the CCM™ signal. In addition, labels are shown indicating when the following conditions occur: • PVC: two successive ventricular sensed events without an intervening atrial sensed event •...

  • Page 37: Status Bar

    Ventricular Tachycardia rate limit. When the OPTIMIZER IVs device is in Marker Mode and within communications range of the OMNI II Programmer, the contents of the Statistics counters change dynamically, showing the current number of occurrences of each event type.

  • Page 38: Graphic View

    Graphic View A graphical view is available on the OMNI II Programmer Software to display some of the OPTIMIZER IVs device parameters in an easy-to-understand graph. This window displays the following parameter values: • Right Heart Sensing o Atrial Sensitivity...

  • Page 39: Dynamic View

    • 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. • The balance phase is displayed as a green zone. •...

  • Page 40: Static View

    3.2.2 Static View In the Static View the ECG is not displayed, only the 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 41: Interrogating The Optimizer Ivs Ipg

    Mini Charger to display a numerical code corresponding to the limit that has been exceeded. There is a Programming Tab in the OMNI II Programmer Software for each one of these groups. Parameter values can be viewed and modified on the screens marked by these tabs.

  • Page 42: Parameter Color Convention

    Typical conflicts arise from trying to program timing intervals that should add up to less than another programmed parameter. The OMNI II Programmer will not allow the OPTIMIZER IVs IPG to be programmed with parameter values that will result in a parameter conflict.

  • Page 43: Programming

    Select the Program icon under the File tab of the Menu Bar, or o Select the Program button on the Programming Bar If the programming is successful, the OMNI II Programmer will display the message “Programming OK”. However if the Programmer Wand is not well positioned over the implant site, the programming operation may fail.

  • Page 44: Cancel And Undo Functions

    Program command, or • Selecting the Undo icon under the File tab of the Menu Bar If the Undo operation is successful, the OMNI II Programmer will display the message “Programming OK”.

  • Page 45: Using Standards

    OMNI II Programmer Software can interpret. The file extension used for them is “.tip”. The Open and Save commands of the OMNI II Programmer read and write data from and to .tip files. As such, the OMNI II Programmer Software can also be used as an editor of standards.

  • Page 46: Log And Ecg Recording

    Log And ECG Recording 3.8.1 Log The OMNI II Programmer keeps a log of all the interactions that take place between it and an OPTIMIZER IVs IPG. This record can be used as an index to provide fast access to specific data associated with the communications.

  • Page 47: Emergency Programming

    Impulse Dynamics representative. This battery is not intended to be replaced by the operator. To perform any other operation, it is necessary to turn ON the OMNI II Programmer System. 3.9.2 Emergency Programming When the Programmer is ON The Urgent Programming command can be used to program the OPTIMIZER IVs IPG with a safe parameter set (OOO Mode, CCM OFF).

  • Page 48: Magnet Mode

    OPTIMIZER IVs IPG in Permanent Off status. Note: This feature is useful for turning off CCM™ signal delivery when an OMNI II 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 OMNI II Programmer).

  • Page 49: Initiating Ccm™ Delivery

    IMPORTANT: If a unit is found in “DOWN” mode, please document the event before resetting the device. After recording the cause of the reversion displayed by the OMNI II Programmer, contact your Impulse Dynamics representative. Also, please provide details of the programmed mode in which the reversion occurred, and any conditions that may have caused the device to revert to “DOWN”...

  • Page 50: Ccm™ Signal Delivery Options

    Retry can be performed by repositioning the Programmer Wand and selecting the Retry button or by pressing the Program button located on the Programmer Wand. 3.12.2 CCM™ Signal Delivery Options CCM™ signal delivery by the OPTIMIZER IVs IPG is set by the CCM OFF button under the CCM™...

  • Page 51: Marker Events

    Wand. 3.13 Marker Events The OMNI II Programmer can be used to set the OPTIMIZER IVs IPG into Marker Mode. 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 IVs IPG are displayed in the patient’s ECG window synchronized with the...

  • Page 52: Sensed Events

    In all cases, the Programmer reports “Marker mode end OK”. Whenever a communication command between the OPTIMIZER IVs device and the OMNI II Programmer takes place (programming, reading statistics, measuring impedances, etc), the Marker Mode automatically ends and is re-established when the communication has finished.

  • Page 53: Log Browser Window

    3.13.7 Log Browser Window When the Log Browser icon under the Log tab is selected, the corresponding window titled Marker Window is displayed. Figure 24: Marker Window For the OPTIMIZER IVs IPG the log browser window is composed of the following elements: •...

  • Page 54: Statistics

    The OPTIMIZER IVs IPG accrues a statistical record of events and conditions that occur as it functions. This record can be loaded into the OMNI II Programmer, and appears in the Statistics window of the OMNI II Programmer software, indicating the number of occurrences of each event type.

  • Page 55: Loading Statistics

    Retry can be performed by repositioning the Programmer Wand and selecting the Retry button. When the OPTIMIZER IVs IPG is in Marker Mode and within communications range of the OMNI II Programmer Wand, the contents of the Statistics counters change dynamically, showing the current number of occurrences of each event type.
  • Page 56  Normal: number of normal periods during scheduled CCM™ delivery  Inhibited: number of inhibited periods during scheduled CCM™ delivery  Post-Inhibited: number of post-inhibited periods during scheduled CCM™ delivery o Trains Delivered  During Onset: number of CCM™ trains delivered during the onset of scheduled CCM™...

  • Page 57: Resetting Device Counters

    3.15.1.2 Statistics Window Buttons • Read: Reads statistics from IPG. • Reset: Resets statistics inside IPG. • Graphic: Displays histogram of statistics from active tab – see Figure 26. • Print: Prints the statistics • Close: Closes Statistics Window. Figure 26: Statistics Histogram 3.15.2 Resetting Device Counters In order to reset the OPTIMIZER IVs IPG Statistics counters to zero: •...

  • Page 58: Measuring Lead Impedances

    The impedance of the LS and RV leads can be measured by the OPTIMIZER IVs IPG and displayed by the OMNI II Programmer. A CCM™ signal is delivered through the selected channel by the OPTIMIZER IVs IPG in order to measure the lead impedance. A pulse train with the following parameters is used for impedance measurement: •...

  • Page 59: Setting The Optimizer Ivs Ipg And Omni Ii Clocks

    3.17 Setting the OPTIMIZER IVs IPG and OMNI II Clocks The time of day is maintained by an internal clock within the OPTIMIZER IVs IPG and is used by the cardiac contractility modulation Therapy Delivery Scheduling mechanism to turn the CCM™ Signal on and off in accordance with the programmed CCM™...

  • Page 60: Setting The Optimizer Ivs Device Real Time Clock

    3.17.2 Setting the OPTIMIZER IVs Device Real Time Clock You can set the OPTIMIZER IVs device real-time clock either manually or by using the computer’s clock. In both cases: • Place (or replace, if necessary) the Programmer Wand over the OPTIMIZER IVs IPG.

  • Page 61: Setting The Omni Ii Programmer Clock

    • Select the Set system time… icon under the Tools tab of the Menu Bar. • A Set system time window will appear which has a calendar and also the current OMNI II Programmer time. The current system date is highlighted. Figure 29: Set system time Window •...

  • Page 62: 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 RV and LS lead impedance by either the OMNI II Programmer or OPTIMIZER Mini Charger are stored in the OPTIMIZER IVs IPG.

  • Page 63: Local Sense (Ls) Diagnostics

    CCM™ trains are delivered in synchronism with intrinsic ventricular events detected by the Local Sense channel through the LS Lead. The OMNI II Programmer has a LS Diagnostic tool which can be used to select appropriate operating parameters for the LS channel.
  • Page 64 Programmer values only. The selected parameters must be programmed into the OPTIMIZER IVs IPG using the Program command), or • Select the Cancel button. This command resets the parameters of the OMNI II Programmer to the last interrogated/programmed values.

  • Page 65: Remote Operation

    Internet. Once connected, the operation is identical to the normal (local) operation, except that some commands may be disabled depending on the operating mode. In order to initiate a remote operation session, the OMNI II Programmer must be connected to the Internet. The OMNI II Programmer supports wireless networks and Ethernet cable connections.
  • Page 66 The Network configuration window will appear. Note: If no wireless networks appear, click on the “Refresh” button to view the available wireless networks within range of the OMNI II Programmer. Figure 32: Network Configuration Window...
  • Page 67 • Status: status of the connection. A green circle will indicate that the OMNI II Programmer can connect with the server, while a red circle will indicate that some problem is preventing the programmer from connecting with the server.

  • Page 68: Omni Ii Operation Modes

    3.20.3 OMNI II Operation Modes 3.20.3.1 OMNI II Startup Modes The OMNI II Programmer can be opened in one of the following modes: • Clinical Mode o for local operation in a clinical setting  The OMNI II Programmer Tablet PC must be connected to the OMNI II Programmer Interface Box using the Interface Box cable.

  • Page 69: Omni Ii Programmer Client Window

    3.20.4 OMNI II Programmer Client Window Note: In order to connect the OMNI II Programmer to the OMNI Remote Server, the OMNI II Programmer must first be connected to Internet. See Sections 3.20.1 and 3.20.2 on ways to connect the OMNI II Programmer to the Internet.
  • Page 70 Dynamics before the OMNI II Programmer is shipped and does not need to be changed.) Note: To use the remote operation feature of the OMNI II Programmer, a user must receive a unique user name and password from Impulse Dynamics. An appropriate Client Name must also be registered with Impulse Dynamics.

  • Page 71: Starting A Remote Session With The Omni Ii Programmer

    Window icon under the Communication tab of the Menu Bar. 3.20.5 Starting a Remote Session with the OMNI II Programmer To start an OMNI II remote session, the clinician at the clinic has to first call the Remote Follow-up Center via the telephone to request a remote follow-up session.

  • Page 72: Ending An Omni Ii Remote Session

    Meanwhile, the “Operation Mode” in the Programming Bar of the Remote Programmer will change to R/Master. 3.20.6 Ending an OMNI II Remote Session An OMNI II remote session can be terminated from either the Clinical or Remote Programmer. In order to terminate an OMNI II remote session: •...
  • Page 73 Log tab of the Menu Bar. Figure 36: OMNI II Programmer Log Upload/Download Window 3.20.8.2 OMNI II Refresh Local In order to display the local log files stored on the OMNI II Programmer, click the Refresh Local button. 3.20.8.3 OMNI II Refresh Server In order to display the log files stored on the server, the OMNI II Programmer must first be connected to Internet.

  • Page 74: Omni Smart Programmer Software

    OMNI II Log Files Upload In order to send log files to the server you must be connected to Internet and provide same information as above. This operation shall be performed only when the OMNI II Programmer is operating in Clinical Mode. 3.20.8.5...

  • Page 75: Title Bar

    Figure 37: OMNI Smart Programmer Main Screen 4.1.1 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: • A OPTIMIZER Smart IPG, in which case the serial number of the device, and the date and time of the last interrogation are shown, or •...

  • Page 76: View Bar

    The trace and color references are shown in the ECG Reference Bar. Figure 39: ECG Reference Bar 4.1.3 View Bar The View Bar contains the buttons for following commands: • Marker view: displays the ECG window in Marker view • Graph view: displays the ECG window in Graph view •...
  • Page 77 Warning: The displayed ECG should not be used for clinical decision making. Medical decisions should only be based on an independent ECG measurement device. • CCM™ signal delivery state is indicated by labels as well as by the background color of the ECG window as follows: o Inactive: this label appears at the top left of the ECG window as long as the CCM™...
  • Page 78 o CCM™ signal initial amplitude o Phase duration of individual phases in each CCM™ pulse in CCM™ pulse train This window also displays a marker at the top left of the display indicating cursor position in msec. It also places the text ‘Modified’ alongside the marker when a parameter has been changed while in this window.

  • Page 79: Ecg Statistics Bar

    Figure 42: Graphic View (Static) Left-clicking the keyboard mouse button or touching the screen with the stylus causes the graph to zoom in. Right-clicking the keyboard mouse button or touching the screen with the stylus’ button depressed causes the graph to zoom out. A scrollbar appears in the bottom of the graph when it is zoomed in.

  • Page 80: Main Tool Bar

    When the OPTIMIZER Smart IPG is in Marker Mode and within communications range of the OMNI II Programmer Wand, the Period, AV Delay, and V-LS Delay intervals change dynamically, showing the current reading for each value. 4.1.5 Main Tool Bar The Main Tool Bar is displayed under the ECG Window.

  • Page 81: Device Bar

    by the CCM™ signal delivery scheduling mechanism to turn CCM™ signal delivery on and off on a daily basis). • Print Preview: Opens up the Print Preview window containing following buttons that can be selected for previewing their associated print functions: o Print Parameters: The list of the current OMNI Smart Programmer values to be printed is previewed.

  • Page 82: Log Bar

    4.1.7 Log Bar A special file in the OMNI Smart Programmer Software contains a record (log) of all the interactions between the OPTIMIZER Smart IPG and the OMNI Smart Programmer, including the date and time when these interactions occurred. Figure 46: Log Bar More information regarding an event in the log may be obtained by double- clicking on the event in the Log Bar.

  • Page 83: Parameter Conflict Bar

    Figure 47: Programming Bar 4.1.9 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.
  • Page 84 4.1.10.1 Follow Up The Follow Up bar contains the following tabs, each with their own panel: • Current Status: displays the current IPG status. • Sensing: contains the atrium, ventricle, and LS sensing threshold buttons which allows the user to measure the atrium and ventricle sensing thresholds.
  • Page 85 Figure 52: AV Setup Tab Figure 53: LS Setup Tab Figure 54: Impedance Tab Figure 55: Crosstalk Test Tab...
  • Page 86 IPG Version: Displays the firmware version of the interrogated IPG. o Interface battery: Reads the battery voltage of the lithium battery inside the OMNI II Programmer Interface Box. o Interface version: Displays the firmware version of the OMNI II Programmer Interface Box.
  • Page 87 Figure 57: A/V Tab Figure 58: LS Tab Figure 59: CCM™ Train & Schedule Figure 60: Alarms Tab...
  • Page 88 Figure 61: Settings Tab Parameter values are displayed in two different ways: • For enabling/disabling parameters (such as CCM™ Channels), checkboxes are used, and a  symbol indicates that the option is selected. To change the option, select the box to the left of the parameter name.
  • Page 89 4.1.10.3 Statistics The Statistics Bar 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™...

  • Page 90: Status Bar

    • Slave: puts the local OMNI Smart Programmer in Slave mode and allows the Remote user to control the local programmer. • Client: displays the OMNI II Programmer Client window (if a remote session was initiated). Figure 65: Tool Bar with Remote Commands 4.1.11 Status Bar...

  • Page 91: Interrogation

    Interrogation 4.2.1 Communicating with the Implanted OPTIMIZER Smart IPG Place the Programmer Wand over the implant site, at a distance of no more than 3.5 cm (1.4 in) from the implanted OPTIMIZER Smart IPG. A blinking green or yellow light on the signal strength indicator indicates that the IPG is within communications range of the Programmer Wand.

  • Page 92: Parameter Color Convention

    • Select the new value from the list. This value will become the new parameter value. • Checkboxes are used for enabling/disabling parameters. A check () symbol indicates that the option is selected. In order to change the option, select the box to the left of the parameter name.

  • Page 93: Programming

    To resolve a parameter conflict, new values must be selected for the parameters that are causing the conflict. Viewing the conflicting parameters may be rapidly achieved by: • Select the error message. A list of the parameters in conflict appears. •...

  • Page 94: Cancel And Undo Functions

    Retry can be performed by repositioning the Programmer Wand and selecting the Retry button or by pressing the Program button located on the Programmer Wand. Please note that after executing a Program command, the modified parameter values on the OMNI Smart Programmer Software screen will become black, indicating that they are now the programmed parameter values of the OPTIMIZER Smart IPG.

  • Page 95: Using Standards

    However, if the Programmer Wand is not well positioned over the implant site, the Undo operation may fail. If a failure in communication occurs, the Programmer will display the message “Programming Error” along with the options Retry and Cancel. Retry can be performed by repositioning the Programmer Wand and selecting the Retry button.

  • Page 96: Exporting Data

    • An Open window will pop up containing the names of the marker files that can be loaded. Choose a marker file and then click Open. A Marker window will open up and the color of the text in the Log Window will become blue to indicate that the log does not correspond to the interrogated device.

  • Page 97: Ecg Recording

    4.8.1 Emergency Programming When the Programmer is OFF Note: Even if the Programmer is OFF, the Programmer Wand must still be plugged into the OMNI II Programmer Interface Box before using the Emergency Programming function. To program the OPTIMIZER Smart IPG with a safe parameter set when the OMNI Smart Programmer is OFF: •...

  • Page 98: Emergency Programming When The Programmer Is On

    2.5 V, the battery inside the OMNI II Programmer Interface Box must be replaced. If battery replacement is required, please contact your Impulse Dynamics representative. This battery is not intended to be replaced by the operator. To perform any other operation, it is necessary to turn ON the OMNI Smart Programmer System.

  • Page 99: Initiating Ccm™ Delivery

    IMPORTANT: If a unit is found in “DOWN” mode, please document the event before resetting the device. After recording the cause of the reversion displayed by the OMNI Smart Programmer, contact your Impulse Dynamics representative. Also, please provide details of the programmed mode in which the reversion occurred, and any conditions that may have caused the device to revert to “DOWN”...

  • Page 100: Ccm™ Signal Delivery Options

    • Active OVO-LS-CCM: The device uses only ventricular and local sense events as triggers for CCM™ signal delivery. To program the Operating Mode into the OPTIMIZER Smart IPG: • Place (or replace, if necessary) the Programmer Wand over the OPTIMIZER Smart IPG implant site. •...

  • Page 101: Marker Events

    Selecting Continuous will cause a warning window to appear. This window will reappear every time a programming command is issued to remind the operator that the OPTIMIZER Smart IPG is still set to Continuous mode. Inadvertent extended use of Continuous mode will cause the battery of the OPTIMIZER Smart IPG to prematurely run-down, necessitating frequent recharging sessions.

  • Page 102: Turning Markers Off

    • Place (or replace, if necessary) the Programmer Wand over the OPTIMIZER Smart IPG implant site. • Select the Marker button on the Tool Bar. If the programming is successful, the Programmer reports “Start marker mode”. In the ECG Window of the OMNI Smart Programmer Software, a bar will appear and Marker Events will be displayed as they occur.

  • Page 103: Ccm™ Signal Delivery State

    • VT: Ventricular rate above the ventricular tachycardia rate limit. (Active OVO-LS-CCM mode only) • A Noise: Noise detected on the atrial sense channel. (Active ODO-LS- CCM mode only) • V Noise: Noise detected on the ventricular sense channel. • Long AV: Sensed AV interval exceeds “Long AV” limit. (Active ODO- LS-CCM mode only) •...

  • Page 104: Ccm™ Schedule

    • Vertical scrollbar whenever the signals do not fit in the defined window. • Print button. When an event in the Marker index log window is double-clicked, the Marker Window screen automatically displays the information associated to the event time stamp. Analogous behavior occurs when a command in the log window or the associated indicator in the screen is selected.

  • Page 105: Active Ovo-Ls-Ccm Mode

    • Scheduled 4.14 Active OVO-LS-CCM Mode 4.14.1 Deactivated Parameters in Active OVO-LS-CCM Mode When the OPTIMIZER Smart IPG is set to Active OVO-LS-CCM mode, the device no longer requires the detection of an atrial event in order to deliver cardiac contractility modulation therapy. Thus the parameters associated with atrium heart sensing and atrial events are deactivated.

  • Page 106: Parameter Modifications In Active Ovo-Ls-Ccm Mode

    Figure 74: A/V Tab in Active OVO-LS-CCM Mode 4.14.2 Parameter Modifications in Active OVO-LS-CCM Mode Below is a list of parameters that are modified when the OPTIMIZER Smart IPG is set to Active OVO-LS-CCM: • The display of PVC, AT, Long and Short AV flags in Marker Mode are disabled •...

  • Page 107: Loading Statistics

    “Read Statistics Error” along with the options Retry and Cancel. Retry can be performed by repositioning the Programmer Wand and selecting the Retry button. When the OPTIMIZER Smart IPG is in Marker Mode and within communications range of the OMNI II Programmer Wand, the contents of the...
  • Page 108 Statistics counters change dynamically, showing the current number of occurrences of each event type. 4.15.1.1 Statistics Tabs  On – General • Events o Atrial: number of atrial events sensed during scheduled CCM™ delivery o Ventricular: number of ventricular events sensed during scheduled CCM™...

  • Page 109: Resetting Device Counters

    • Noise Episodes A Noise: number of times atrial noise detected during scheduled CCM™ delivery o V Noise: number of times ventricular noise detected during scheduled CCM™ delivery  Off – General: Displays the same list of statistical counters as detailed under On –...

  • Page 110: Setting The Clocks On The Optimizer Smart Ipg And Omni Smart Programmer

    The impedance of the LS and V leads can be measured by the OPTIMIZER Smart IPG and displayed by the OMNI Smart Programmer. A CCM™ signal is delivered through the selected channel by the OPTIMIZER Smart IPG in order to measure the lead impedance.

  • Page 111: Setting The Optimizer Smart Ipg Real Time Clock

    The real-time clock in the OPTIMIZER Smart 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 IPG: •...

  • Page 112: Setting The Omni Smart Programmer Clock

    Caution: Be certain that you are selecting the correct button. If the time change is successful, the Programmer will display the message “Set time OK”. If the Programmer Wand is not well positioned over the implant site, the interrogation operation may fail. If a failure in communication occurs, the Programmer will display the message “Set Time Error”, along with the options Retry and Cancel.

  • Page 113: Optimizer Smart Ipg Alarms Reported To The Optimizer Mini Charger

    Figure 77: Set system time Window • Using the cursor, select a new date, if required. To adjust the time, select the hour, minute or seconds and then change the value using the up or down arrows to the right of the time display. •...

  • Page 114: Maximum Lead Displacement

    • Select current value for Minimum Target % for CCM Delivery. • When the Min Target for CCM Deliv. (%) window appears, select a new parameter value. • Program the new parameter value to OPTIMIZER Smart IPG. 4.18.2 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.
  • Page 115 The Local Sense Scan screen will appear. The Graph view is shown at the top of the screen and the Sensitivity parameter related to Local Sensing appear on the right pane of the screen. Figure 78: 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.
  • Page 116 Figure 79: Local Sense Scan Screen after Automatic Scan To use the results of the LS Scan: • Select the check box next to the desired sensitivity values. • Select the Go to LS Setup button. • Once the application returns to the LS Setup panel, select the check box under LS 1 column of the Measurement box.

  • Page 117: Crosstalk Test

    Figure 80: LS Setup Screen after Selection of Propose LS Button 4.20 Crosstalk Test The OMNI Smart Programmer software 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: •...

  • Page 118: Connecting The Omni Smart Programmer To A Wired Ethernet Network

    4.21.1 Connecting the OMNI Smart Programmer to a Wired Ethernet Network Note: The connection of the OMNI II Programmer Tablet PC to a wired internet network must only be done through the medical-grade Ethernet isolator. If use of the Remote Operation Mode is desired, and connection to the Internet is...
  • Page 119 Figure 81: Configuration Dialog Window Click the “Network Configuration” button to setup the connection with the server or change network settings. The Network configuration window will appear. Note: If no wireless networks appear, click on the “Refresh” button to view the available wireless networks within range of the OMNI Smart Programmer.

  • Page 120: Omni Smart Operation Modes

    • Show MAC Addresses: A Network adapters MACs’ addresses dialog window will appear detailing the MAC address of each network adapter installed in the OMNI II Programmer Tablet PC. • Close: closes the window. 4.21.3 OMNI Smart Operation Modes 4.21.3.1...
  • Page 121 • Clinical Mode: for local operation in a clinical setting o The OMNI II Programmer Tablet PC must be connected to the OMNI II Programmer Interface Box using the Interface Box cable. • Remote Mode: for remote operation of an OMNI Smart...

  • Page 122: Omni Ii Programmer Client Window

    Sections 4.21.1 and 4.21.2 on ways to connect the OMNI Smart Programmer to the Internet. The Omni II Programmer Client window is used to log in to the Client Server. To open the OMNI II Programmer Client window: • Select the Remote button on the Task Bar •...

  • Page 123: Starting A Remote Session With The Omni Smart Programmer

    OMNI II Programmer Wand. 4.21.4.2 Show OMNI II Programmer Client Window In order to show the OMNI II Programmer Client window after the Programmer has logged on to the Remote Server: • Select the Remote button on the Task Bar.
  • Page 124 Select the Remote button on the Task Bar. o Select the Connect button on the Tool Bar. o When the Omni II Client window appears, enter the User name, password, and Client name in the appropriate spaces and then select Connect.

  • Page 125: Ending An Omni Smart Programmer Remote Session

    If you receive a chat message while the Chat message window is closed, the window will pop up automatically. Figure 85: Chat message Window 4.21.8 OMNI II Log Upload/Download The OMNI Smart Programmer allows uploading and downloading of log files to and from the OMNI Remote Server.
  • Page 126 Figure 86: Omni II Programmer Log Upload/Download Window 4.21.8.2 OMNI II Refresh Local In order to display the local log files stored on the OMNI Smart Programmer, click the Refresh Local button. 4.21.8.3 OMNI II Refresh Server In order to display the log files stored on the server, the OMNI Smart Programmer must first be connected to Internet.

  • Page 127: Bluetooth Printer

    4.21.8.4 OMNI II Log Files Upload In order to send log files to the server you must be connected to Internet and provide same information as above. This operation shall be performed only when the OMNI Smart Programmer is operating in Clinical Mode.

  • Page 128: Set Default Printer

    • Then click the Set Bluetooth button. The Bluetooth Settings window will appear. Figure 87: Bluetooth Settings Window • Click on the Discover button to search for Bluetooth devices. • If “Zebra Printer (Authenticated) appears, select it and then click the Delete button.

  • Page 129: Log File Manager

    LOG FILE MANAGER The Log File Manager allows the user to copy and delete log files stored on the OMNI Smart Programmer. To copy and delete the stored log files: • At the Selector screen, click the Log File Manager button. The Insert Password window will appear.

  • Page 130: Optimizer Mini Charger

    o Click the Copy button. o Wait for the pop-up Information window to appear stating Copy completed and then click OK. o Click on the X to close the Log File Manager 2.0 window. OPTIMIZER MINI CHARGER Description The OPTIMIZER Mini Charger is a charger powered by a rechargeable battery. The system includes a permanently attached charging wand.

  • Page 131: Charger Features

    • Carrying Case – used to transport the OPTIMIZER Mini Charger • Patient belt – (optional accessory) used to hold the charger in its pocket while the OPTIMIZER Smart IPG is being charged. (Manufacturer: Spider Black Widow Holster) Charger Features The following explains the features of the OPTIMIZER Mini Charger.

  • Page 132: Charger Operation

    The charging current of the OPTIMIZER Mini Charger is fixed at 90mA. The OPTIMIZER Mini Charger operates at a frequency range of 410 kHz – 490 kHz. Note: The OPTIMIZER Mini Charger is subject to interference from other electrical devices operated in the vicinity. Portable and mobile radio frequency equipment is especially prone to impair the normal function of the charger.

  • Page 133: Frequency Of Charging Sessions

    • Once the charging wand has established a link with the OPTIMIZER Smart IPG, the OPTIMIZER Mini Charger will begin the charging process. Note: Improper positioning or displacement of the charging wand is indicated by the corresponding a low signal strength on IPG-Charger Coupling Signal Strength Indicator on the charger and by an audible signal sounding approximately once per second.

  • Page 134: Numerical Codes

    When Numerical Code 0 is displayed, it means that the OPTIMIZER Smart IPG has been deactivated and placed in Down mode. If this Numerical Code is displayed by the charger, please contact your Impulse Dynamics representative. 7.6.2 Numerical Code 1...

  • Page 135: Numerical Code 5

    OPTIMIZER Smart IPG during charging increases by more than 3° for over 10 minutes. If this Numerical Code is displayed repeatedly by the charger over the course of several days, please contact your Impulse Dynamics representative. 7.6.7 Numerical Code 6 When Numerical Code 6 is displayed, it means that the OPTIMIZER Mini Charger has detected a fault within the charger itself.

  • Page 136: Maintenance

    Maintenance The OPTIMIZER Mini Charger does not contain any user serviceable parts. If the OPTIMIZER Mini 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 OPTIMIZER Mini Charger is expected to have a service life of 5 years.

  • Page 137: Electromagnetic Interference Information (Table 1 Of 5)

    APPENDIX I Electromagnetic interference information (Table 1 of 5): GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The OPTIMIZER Smart System (the OMNI Smart Programmer and the OPTIMIZER Mini Charger) is intended for use in an electromagnetic environment as specified below. The customer or user of the OPTIMIZER Smart System has to ensure that it is used in such an environment.

  • Page 138: Electromagnetic Interference Information (Table 2 Of 5)

    The operator may have to reset the and ± 6 kV; and ± 6 kV; system if the communication between the OMNI II Interface Box and the air discharge: ± 2 kV, air discharge: Tablet PC is interrupted. ± 4 kV, and ± 8 kV ±...

  • Page 139: Electromagnetic Interference Information (Table 3 Of 5)

    Electromagnetic interference information (Table 3 of 5): GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY (133) The OMNI Smart Programmer and the OPTIMIZER Mini Charger are intended for use in an electromagnetic environment as specified below. The customer or user of the OPTIMIZER Smart system has to ensure that the equipment is used in such an environment.

  • Page 140: Electromagnetic Interference Information (Table 4 Of 5)

    Electromagnetic interference information (Table 4 of 5): Recommended separation distances between portable and mobile RF communications equipment and the OMNI Smart Programmer or OPTIMIZER Mini Charger Both the OMNI Smart Programmer and the OPTIMIZER Mini Charger should be used in an electromagnetic environment with limited radiated RF noise.

  • Page 141: Communications/Telemetry

    APPENDIX II Communications/Telemetry Between the OPTIMIZER Mini IPG and the OMNI II Programmer: • OPTIMIZER Mini IPG to OMNI II Programmer: o PPM: “0” = 180 µs, “1” = 270 µs o 14.5 kHz LC excited by pulse o 1 cycle per pulse until dampened to 10% o Energy invested per pulse 0.36 µJ →...

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