ENERGEN ICD Reference Guide

ABOUT THIS MANUAL This family of implantable cardioverter defibrillators (ICDs) contains both single- and dualchamber pulse generators that provide ventricular tachyarrhythmia therapy, bradycardia pacing, and a variety of diagnostic tools. The organization of the manuals provided for Boston Scientific pulse generators has changed. System Guides have been replaced by Reference Guides, and the Physician’s Technical Manual has been expanded. The Reference Guide contains the following sections formerly covered in the System Guide: Using the Programmer/Recorder/Monitor, Tachyarrhythmia Detection, Tachyarrhythmia Therapy, Pacing Therapies, System Diagnostics, Patient Diagnostics and Follow Up, Electrophysiological Testing, Programmable Options, and Pacemaker Interactions. Information for Use, Implant Information, and Post Implant Information, topics formerly covered in the System Guide, can now be found in the Physician’s Technical Manual. For copies of any of these documents, contact Boston Scientific using the information on the back cover. Boston Scientific Corporation acquired Guidant Corporation in April 2006. During our transition period, you may see both the Boston Scientific and Guidant names on product and patient material. As we work through the transition, we will continue to offer doctors and their patients technologically advanced and high quality medical devices and therapies. The text conventions discussed below are used throughout this manual. PRM KEYS

The names of Programmer/Recorder/Monitor (PRM) keys appear in capital letters (e.g., PROGRAM, INTERROGATE).

1., 2., 3.

Numbered lists are used for instructions that should be followed in the order given.

•

Bulleted lists are used when the information is not sequential.

This product family includes single- and dual-chamber models, with feature variations. This manual describes the full-featured model (e.g., a dual-chamber model with ZIP telemetry). Some models will contain fewer features; for those devices, disregard descriptions of the unavailable features. The screen illustrations used in this manual are intended to familiarize you with the general screen layout. The actual screens you see when interrogating or programming the pulse generator will vary based on the model and programmed parameters. A complete list of programmable options is provided in the appendix ("Programmable Options" on page A-1). The actual values you see when interrogating or programming the pulse generator will vary based on the model and programmed parameters. The following acronyms may be used in this Reference Guide: A AF AFib AFR AGC AIVR AT ATP

Atrial Atrial Fibrillation Atrial Fibrillation Atrial Flutter Response Automatic Gain Control Accelerated Idioventricular Rhythm Atrial Tachycardia Antitachycardia Pacing

The following are trademarks of Boston Scientific or its affiliates: AUTONOMIC BALANCE MONITOR, ENERGEN, Onset/Stability, Quick Convert, RHYTHM ID, Safety Core, Smart Blanking, VENTAK, VITALITY, ZIP, ZOOM, ZOOMVIEW.

ATR AV BCL CPR DFT EAS ECG EF EGM EMI EP HE IBP ICD LRL MI MPR MRI MSR MTR NSR PAC PAT PES PMT PRM PSA PTM PVARP PVC RADAR RF RTTE RV RVRP SCD SRD SVT TARP TENS V VF VFib VRP VRR VT VTR

Atrial Tachy Response Atrioventricular Burst Cycle Length Cardiopulmonary Resuscitation Defibrillation Threshold Electronic Article Surveillance Electrocardiogram Ejection Fraction Electrogram Electromagnetic Interference Electrophysiology; Electrophysiologic High Energy Indications-Based Programming Implantable Cardioverter Defibrillator Lower Rate Limit Myocardial Infarction Maximum Pacing Rate Magnetic Resonance Imaging Maximum Sensor Rate Maximum Tracking Rate Normal Sinus Rhythm Premature Atrial Contraction Paroxysmal Atrial Tachycardia Programmed Electrical Stimulation Pacemaker-Mediated Tachycardia Programmer/Recorder/Monitor Pacing System Analyzer Patient Triggered Monitor Post-Ventricular Atrial Refractory Period Premature Ventricular Contraction Radio Detection and Ranging Radio Frequency Radio and Telecommunications Terminal Equipment Right Ventricular Right Ventricular Refractory Period Sudden Cardiac Death Sustained Rate Duration Supraventricular Tachycardia Total Atrial Refractory Period Transcutaneous Electrical Nerve Stimulation Ventricular Ventricular Fibrillation Ventricular Fibrillation Ventricular Refractory Period Ventricular Rate Regulation Ventricular Tachycardia Ventricular Tachycardia Response

TABLE OF CONTENTS USING THE PROGRAMMER/RECORDER/MONITOR... CHAPTER 1

1-1

ZOOM LATITUDE Programming System ...

1-2

Software Terminology and Navigation ... Main Screen... PRM Mode Indicator ... ECG/EGM Display ... Toolbar ... Tabs ... Buttons... Icons ... Common Objects ... Use of Color ...

1-2 1-2 1-3 1-3 1-4 1-4 1-5 1-5 1-6 1-6

Demonstration Mode ...

1-7

Communicating with the Pulse Generator ... ZIP Telemetry... Starting a Wanded Telemetry Session ... Starting a ZIP Telemetry Session... Ending a Telemetry Session ... ZIP Telemetry Security...

1-7 1-8 1-8 1-8 1-9 1-9

Indications-Based Programming (IBP) ...

1-11

Manual Programming ...

1-13

DIVERT THERAPY ...

1-13

STAT SHOCK ...

1-14

STAT PACE ...

1-14

Data Management ... Patient Information... Data Storage... Device Memory ... Print...

1-15 1-15 1-15 1-16 1-16

Safety Mode ... Backup Pacemaker... Backup Defibrillator... Programming the Device Safety Tachy Mode...

1-16 1-16 1-17 1-17

TACHYARRHYTHMIA DETECTION... CHAPTER 2

2-1

Device Mode... Ventricular Tachy Mode... Electrocautery Protection Mode...

2-2 2-2 2-2

Rate Sensing ... Calculating Rates and Refractory Periods ... Ventricular Rate Thresholds and Zones... Use of Atrial Information ...

2-3 2-3 2-3 2-4

Ventricular Detection ... Ventricular Detection Enhancement Suites...

2-5 2-5

Ventricular Redetection... 2-8 Ventricular Post-shock Detection Enhancements ... 2-9 Ventricular Detection Details... 2-10 TACHYARRHYTHMIA THERAPY ... CHAPTER 3

3-1

Ventricular Therapy ... Ventricular Therapy Prescription... Ventricular Therapy Selection ... Ventricular Redetection after Ventricular Therapy Delivery ... Ventricular Redetection after Ventricular ATP Therapy... Ventricular Redetection after Ventricular Shock Therapy ...

3-2 3-2 3-2 3-6 3-6 3-7

Antitachycardia Pacing Therapies and Parameters ... 3-7 Burst Parameters ... 3-8 Coupling Interval and Coupling Interval Decrement ... 3-9 Burst Cycle Length (BCL) ... 3-10 Minimum Interval... 3-10 Burst Scheme ... 3-11 Ramp Scheme ... 3-11 Scan Scheme... 3-12 Ramp/Scan Scheme ... 3-12 ATP Pulse Width and ATP Amplitude ... 3-13 Ventricular ATP Time-out ... 3-13 QUICK CONVERT ATP ... 3-14 Ventricular Shock Therapy and Parameters... Ventricular Shock Vector... Ventricular Shock Energy... Charge Time ... Waveform Polarity... Committed Shock/Reconfirmation of the Ventricular Arrhythmia ...

3-15 3-15 3-15 3-15 3-16 3-17

PACING THERAPIES ... CHAPTER 4

4-1

Pacing Therapies...

4-2

Basic Parameters ... Brady Mode... Lower Rate Limit (LRL) ... Maximum Tracking Rate (MTR) ... Maximum Sensor Rate (MSR) ... Pulse Width... Amplitude ... Sensitivity...

4-2 4-2 4-3 4-4 4-4 4-5 4-6 4-6

Post-Therapy Pacing ... Post-Shock Pacing Delay ... Post-Therapy Period ...

4-7 4-7 4-7

Temporary Pacing...

4-7

Sensors and Trending ... Sensor Trending... Adaptive-rate Pacing... Accelerometer...

4-8 4-8 4-9 4-9

Atrial Tachy Response... ATR Mode Switch ... Ventricular Rate Regulation (VRR) ...

4-14 4-14 4-17

Atrial Flutter Response (AFR)... PMT Termination...

4-18 4-18

Rate Enhancements ... Rate Hysteresis... Rate Smoothing ...

4-20 4-20 4-21

Lead Configuration ...

4-23

AV Delay... Paced AV Delay ... Sensed AV Delay ... AV Search+ ...

4-24 4-24 4-25 4-26

Refractory ... A-Refractory (PVARP) ... RV-Refractory (RVRP) ... Cross-Chamber Blanking and Noise Rejection...

4-27 4-27 4-28 4-28

Noise Response ...

4-31

Ventricular Tachy Sensing Interactions...

4-32

SYSTEM DIAGNOSTICS... CHAPTER 5

5-1

Summary Dialog ...

5-2

Battery Status ... Capacitor Re-formation... Charge Time Measurement ... Last Delivered Ventricular Shock ...

5-2 5-5 5-6 5-6

Leads Status...

5-6

Lead Tests ... 5-9 Intrinsic Amplitude Test ... 5-10 Lead Impedance Test... 5-11 Pace Threshold Test ... 5-11 PATIENT DIAGNOSTICS AND FOLLOW UP ... CHAPTER 6

6-1

Therapy History ...

6-2

Arrhythmia Logbook ...

6-3

Patient Diagnostics... Histograms... Counters ...

6-7 6-7 6-8

Trends ...

6-9

Post Implant features... Patient Triggered Monitor... Sensitivity Adjustment... Beeper Feature ... Magnet Feature...

6-10 6-10 6-11 6-12 6-13

ELECTROPHYSIOLOGIC TESTING... CHAPTER 7

7-1

EP Test Features ... Temporary EP Mode ... Backup Ventricular Pacing During Atrial EP Testing ... EP Test Screen ...

7-2 7-2 7-2 7-2

Induction Methods ... VFib Induction ... Shock on T Induction ... Programmed Electrical Stimulation (PES) ... 50 Hz/Manual Burst Pacing ...

7-4 7-4 7-5 7-5 7-6

Commanded Therapy Methods ... Commanded Shock ... Commanded ATP...

7-7 7-8 7-8

PROGRAMMABLE OPTIONS... APPENDIX A

A-1

PACEMAKER INTERACTION ... APPENDIX B

B-1

SYMBOLS ON PACKAGING... APPENDIX C

C-1

Symbols on Packaging ...

C-1

1-1

USING THE PROGRAMMER/RECORDER/MONITOR CHAPTER 1 This chapter contains the following topics: •

"ZOOM LATITUDE Programming System" on page 1-2

•

"Software Terminology and Navigation" on page 1-2

•

"Demonstration Mode" on page 1-7

•

"Communicating with the Pulse Generator" on page 1-7

•

"Indications-Based Programming (IBP)" on page 1-11

•

"Manual Programming" on page 1-13

•

"DIVERT THERAPY" on page 1-13

•

"STAT SHOCK" on page 1-14

•

"STAT PACE" on page 1-14

•

"Data Management" on page 1-15

•

"Safety Mode" on page 1-16

1-2

USING THE PROGRAMMER/RECORDER/MONITOR ZOOM LATITUDE PROGRAMMING SYSTEM

ZOOM LATITUDE PROGRAMMING SYSTEM The ZOOM LATITUDE Programming System is the external portion of the pulse generator system and includes: •

Model 3120 Programmer/Recorder/Monitor (PRM)

•

Model 2868 ZOOMVIEW Software Application

•

Model 6577 Accessory Telemetry Wand

The ZOOMVIEW software provides advanced device programming and patient monitoring technology. It was designed with the intent to: •

Enhance device programming capability

•

Improve patient and device monitoring performance

•

Simplify and expedite programming and monitoring tasks

You can use the PRM system to do the following: •

Interrogate the pulse generator

•

Program the pulse generator to provide a variety of therapy options

•

Access the pulse generator’s diagnostic features

•

Perform noninvasive diagnostic testing

•

Access therapy history data

•

Access an interactive Demonstration Mode or Disk Mode without the presence of a pulse generator

•

Print patient data including pulse generator therapy options and therapy history data

You can program the pulse generator using two methods: automatically using IBP or manually. For more detailed information about using the PRM, refer to the PRM Operator’s Manual.

SOFTWARE TERMINOLOGY AND NAVIGATION This section provides an overview of the PRM system.

Main Screen The main PRM screen is shown below, followed by a description of the components (Figure 1-1 on page 1-3).

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

Patient name

PRM Mode Indicator

1-3

Device name

Details button

ECG/EGM display

Tabs

Device model

Toolbar

Figure 1-1.

Main Screen

PRM Mode Indicator The PRM Mode Indicator displays at the top of the screen to identify the current PRM operational mode. Patient-indicates that the PRM is displaying data obtained by communicating with a device.

Patient Data-indicates that the PRM is displaying stored patient data.

Demo Mode-indicates that the PRM is displaying sample data and operating in demonstration mode.

ECG/EGM Display The ECG area of the screen shows real-time status information about the patient and the pulse generator that can be useful in evaluating system performance. The following types of traces can be selected: •

Surface ECGs are transmitted from body surface lead electrodes that are connected to the PRM, and can be displayed without interrogating the pulse generator.

1-4

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

•

Real-time EGMs are transmitted from the pace/sense or shocking electrodes, and are often used to evaluate lead system integrity and help identify faults such as lead fractures, insulation breaks, or dislodgments. Real-time EGMs can only be displayed upon interrogation of the pulse generator. Because they rely on ZIP or wanded telemetry, they are susceptible to radio frequency interference. Significant interference may cause a break or drop-out of real-time EGMs ("ZIP Telemetry Security" on page 1-9).

NOTE: In the presence of telemetry interference, the real-time intracardiac EGM traces and markers may become misaligned from the real-time surface ECG traces. When the telemetry link has improved, re-select any of the intracardiac EGM traces to cause re-initialization. You can select the Details button to enlarge the ECG/EGM screen. The following options are available: •

Show Device Markers-displays annotated event markers, which identify certain intrinsic cardiac and device-related events, and provide information such as sensed/paced events, decision of detection criteria, and therapy delivery

•

Enable Surface Filter-minimizes noise on the surface ECG

•

Display Pacing Spikes-shows detected pacing spikes, annotated by a marker on the surface ECG waveform

You can print real-time EGMs, which include annotated event markers, by performing the following steps: 1. Press one of the print speed keys on the PRM (e.g., speed key 25) to begin printing. 2. Press the 0 (zero) speed key to stop printing. 3. Press the paper-feed key to fully eject the last printed sheet. You can print definitions of the annotated markers by pressing the calibration key while the EGM is printing. Alternatively you can print a full report containing the definitions of all of the annotated markers by performing the following steps: 1. From the toolbar, click the Reports button. The Reports window displays. 2. Select the Marker Legend checkbox. 3. Click the Print button. The Marker Legend Report is sent to the printer.

Toolbar The toolbar allows you to perform the following tasks: •

Select system utilities

•

Generate reports

•

Interrogate and program the pulse generator

•

View pending or programmed changes

•

View attentions and warnings

•

End your PRM session

Tabs Tabs allow you to select PRM tasks, such as viewing summary data or programming device settings. Selecting a tab displays the associated screen. Many screens contain additional tabs, which allow you to access more detailed settings and information.

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

1-5

Buttons Buttons are located on screens and dialogs throughout the application. Buttons allow you to perform various tasks, including: •

Obtain detailed information

•

View setting details

•

Set programmable values

•

Load initial values

When a button selection opens a window in front of the Main Screen, a Close button displays in the upper-right corner of the window to allow you to close the window and return to the Main Screen.

Icons Icons are graphic elements that, when selected, may initiate an activity, display lists or options, or change the information displayed. Details-opens a window containing detailed information.

Patient-opens a window with patient information details.

Leads-opens a window with details on leads.

Battery-opens a window with details on the pulse generator battery.

Check-indicates that an option is selected.

Event-indicates that an event has occurred. When you view the Trends timeline on the Events tab, event icons display wherever events have occurred. Selecting an events icon displays details about the event. Action Icons Run-causes the programmer to perform an action.

Hold-causes the programmer to pause an action. Continue-causes the programmer to continue an action.

1-6

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

Slider Icons Horizontal Slider-indicates that a slider object can be clicked and dragged left or right. Vertical Slider-indicates that a slider object can be clicked and dragged up or down. Sort Icons Sort Ascending-indicates that Ascending sort is currently selected on a table column sort button. (e.g., 1, 2, 3, 4, 5) Sort Descending-indicates that Descending sort is currently selected on a table column sort button. (e.g., 5, 4, 3, 2, 1) Increment and Decrement Icons Increment-indicates that an associated value can be incremented.

Decrement-indicates that an associated value can be decremented.

Scroll Icons Scroll Left-indicates that an associated item can be scrolled left.

Scroll Right-indicates that an associated item can be scrolled right.

Scroll Up-indicates that an associated item can be scrolled up. Scroll Down-indicates that an associated item can be scrolled down.

Common Objects Common objects such as status bars, scroll bars, menus, and dialogs are used throughout the application. These operate similarly to the objects found in web browsers and other computer applications.

Use of Color Colors and symbols are used to highlight buttons, icons, and other objects, as well as certain types of information. The use of specific color conventions and symbols is intended to provide a more consistent user experience and simplify programming. Refer to the table below to understand how colors and symbols are used on the PRM screens (Table 1-1 on page 1-7).

USING THE PROGRAMMER/RECORDER/MONITOR DEMONSTRATION MODE

Table 1-1.

PRM color conventions Meaning

Color Red

1-7

Indicates warning conditions

Examples

Symbol

The selected parameter value is not allowed; click the red warning button to open the Parameter Interactions screen, which provides information about corrective action. Device and patient diagnostic information that requires serious consideration.

Yellow

Indicates conditions requiring your attention

The selected parameter value is allowed, but not recommended; click the yellow attention button to open the Parameter Interactions screen, which provides information about corrective action. Device and patient diagnostic information that should be addressed.

Green

Indicates acceptable changes or conditions

The selected parameter value is allowed, but is still pending. There is no device or patient diagnostic information requiring your specific attention.

White

Indicates the value that is currently programmed

DEMONSTRATION MODE The PRM includes a Demonstration Mode feature, which enables the PRM to be used as a self-teaching tool. When selected, this mode allows you to practice PRM screen navigation without interrogating a pulse generator. You can use Demonstration Mode to familiarize yourself with many of the specific screen sequences that will display when interrogating or programming a specific pulse generator. You can also use Demonstration Mode to examine available features, parameters, and information. To access Demonstration Mode, select the appropriate PG from the Select PG screen, and then select Demo from the Select PG Mode dialog. When the PRM is operating in Demonstration Mode, the PRM Mode Indicator displays the Demo Mode icon. The pulse generator cannot be programmed when the PRM is operating in Demonstration Mode. Exit the Demonstration Mode before attempting to interrogate or program the pulse generator.

COMMUNICATING WITH THE PULSE GENERATOR The PRM communicates with the pulse generator using a telemetry wand. After initiating communication with the wand, some pulse generator models can use wandless ZIP telemetry (two-way RF communication) to interface with the PRM.

1-8

USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR

Telemetry is required to: •

Direct commands from the PRM system, such as: –

INTERROGATE

–

PROGRAM

–

STAT SHOCK

–

STAT PACE

–

DIVERT THERAPY

•

Modify device parameter settings

•

Conduct EP testing

•

Conduct diagnostic tests including the following:

•

–

Pacing impedance tests

–

Pacing threshold tests

–

Intrinsic amplitude tests

Perform manual capacitor re-form

ZIP Telemetry ZIP telemetry is a wandless, two-way RF communication option that allows the PRM system to communicate with some pulse generator models. When a wanded telemetry session is initiated, the PRM checks the pulse generator’s telemetry capability. If the PRM detects a pulse generator with ZIP telemetry capability, a message will display indicating that ZIP telemetry is available and the wand can be removed. Otherwise, the session will continue with wanded telemetry. ZIP telemetry offers the following advantages over traditional wanded telemetry: •

The faster data transmission speed means less time is required for device interrogation

•

Data transmission over a longer distance (within 3 m [10 ft]) minimizes the need to keep the wand in the sterile field during implant, which may reduce the risk of infection

•

Continuous telemetry is possible during the entire implant procedure, allowing monitoring of pulse generator performance and lead integrity during implant

Regardless of whether ZIP telemetry is being used, wanded communication is still available.

Starting a Wanded Telemetry Session Follow this procedure to begin a wanded telemetry communication session: 1. Make sure the telemetry wand is connected to the PRM system and is available throughout the session. 2. Position the wand over the pulse generator at a distance not greater than 6 cm (2.4 inches). 3. Use the PRM to Interrogate the pulse generator. 4. Retain the wand position whenever communication is required.

Starting a ZIP Telemetry Session Follow this procedure to begin a ZIP telemetry communication session:

USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR

1-9

1. Start a wanded telemetry session. Verify that the wand cord is within reach of the pulse generator to enable the use of wanded telemetry should it become necessary. 2. Keep the telemetry wand in position until either a message appears, indicating that the telemetry wand may be removed from proximity of the pulse generator, or the ZIP telemetry light illuminates on the PRM system.

Ending a Telemetry Session Select the End Session button to quit a telemetry session and return to the startup screen. You can choose to end the session or return to the current session. Upon ending a session, the PRM system terminates all communication with the pulse generator.

ZIP Telemetry Security The pulse generator is a compliant low-power transceiver. The pulse generator can only be interrogated or programmed by RF signals that employ the proprietary ZIP telemetry protocol. The pulse generator verifies that it is communicating with a ZOOMVIEW system before responding to any RF signals. The pulse generator stores, transmits, and receives individually identifiable health information in an encrypted format. ZIP telemetry is possible when all of the following conditions are met: •

ZIP telemetry setting for the PRM is programmed On

•

The pulse generator has RF communication capabilities

•

The ZIP telemetry channel is available for use

•

The pulse generator is within range of the PRM system

•

The pulse generator has not reached Explant; note that a total of 1.5 hours of ZIP telemetry will be available after the pulse generator reaches Explant

•

The pulse generator battery capacity is not depleted

In order to meet local communications rules and regulations, ZIP telemetry should not be used when the pulse generator is outside its normal operating temperature of 20°C–43°C (68°F–109°F). The PRM supports communication between two PRMs and two pulse generators at a time, as two independent sessions. If there are two PRMs already communicating in the vicinity, a third session will not be allowed to start; wanded communication will be necessary in this case. The PRM notifies you if ZIP telemetry is unavailable because of other sessions already in progress. RF signals in the same frequency band used by the system may interfere with ZIP telemetry communication. These interfering signals include: •

Signals from other pulse generator/PRM system RF communication sessions after the maximum number of independent sessions has been reached. Other nearby pulse generators and PRMs using ZIP telemetry may prevent ZIP telemetry communication.

•

Interference from other RF sources.

1-10

USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR

CAUTION: RF signals from devices that operate at frequencies near that of the pulse generator may interrupt ZIP telemetry while interrogating or programming the pulse generator. This RF interference can be reduced by increasing the distance between the interfering device and the PRM and pulse generator. Examples of devices that may cause interference include: •

Cordless phone handsets or base stations

•

Certain patient monitoring systems

Radio frequency interference may temporarily disrupt ZIP telemetry communication. The PRM will normally reestablish ZIP communication when the RF interference ends or subsides. Because continued RF interference may prevent ZIP telemetry communication, the system is designed to use wanded telemetry when ZIP telemetry is not available. If ZIP telemetry is not available, wanded telemetry communication with the PRM can be established. The system provides the following feedback to indicate that ZIP telemetry is not available: •

The ZIP telemetry indicator light on the PRM turns off

•

If event markers and/or EGMs are activated, transmission of the event markers and/or EGMs is interrupted

•

If a command or other action has been requested, the PRM displays a notification indicating the wand should be placed in range of the pulse generator

ZIP telemetry operates consistently with wanded telemetry-no programming step can be completed unless the entire programming command has been received and confirmed by the pulse generator. The pulse generator cannot be misprogrammed as a result of interrupted ZIP telemetry. Interruptions of ZIP telemetry may be caused by RF signals that operate at frequencies near that of the pulse generator and are strong enough to compete with the ZIP telemetry link between the pulse generator and the PRM. Significant interference may result in a break or drop-outs of real-time EGMs. If commands are interrupted, the PRM displays a message to place the wand on the pulse generator. These situations can be resolved by using standard wanded telemetry. There will be no interruption of device functionality or therapy during this period. NOTE: The PRM operates on a specific frequency range depending on geography. The PRM determines the ZIP frequency range that the pulse generator uses based on the specific device model. If the PRM and pulse generator ZIP frequency ranges do not match, it indicates that the patient has traveled outside their geography. The PRM will display a message indicating that ZIP telemetry cannot be used; however, the patient’s pulse generator can be interrogated by using the wand. Considerations for Reducing Interference Increasing the distance from the source of interfering signals may enable the use of the ZIP telemetry channel. A minimum distance of 14 m (45 ft) is recommended between the source of interference (having an average output of 50 mW or less) and both the pulse generator and PRM. Repositioning the PRM antenna or repositioning the PRM may improve ZIP telemetry performance. If ZIP telemetry performance is not satisfactory, the option of using wanded telemetry is available. Depending on the environment and PRM orientation relative to the pulse generator, the system is capable of maintaining ZIP telemetry communication at distances up to 12 m (40 ft). For optimum ZIP telemetry communication, position the PRM antenna within 3 m (10 ft) of the pulse generator and remove any obstruction between the PRM and the pulse generator.

USING THE PROGRAMMER/RECORDER/MONITOR INDICATIONS-BASED PROGRAMMING (IBP)

1-11

Positioning the PRM at least 1 m (3 ft) away from walls or metal objects and ensuring the pulse generator (prior to implant) is not in direct contact with any metal objects may reduce signal reflection and/or signal blocking. Ensuring there are no obstructions (e.g., equipment, metal furniture, people, or walls) between the PRM and pulse generator may improve signal quality. Personnel or objects that momentarily move between the PRM and pulse generator during ZIP telemetry may temporarily interrupt communication, but will not affect device functionality or therapy. Checking the time required to complete an interrogation after ZIP telemetry is established can provide an indication of whether interference is present. If an interrogation using ZIP telemetry takes less than 20 seconds, the current environment is likely free of interference. Interrogation times longer than 20 seconds (or short intervals of EGM drop-outs) indicate that interference may be present.

INDICATIONS-BASED PROGRAMMING (IBP) IBP is a tool that provides specific programming recommendations based on the patient’s clinical needs and primary indications. IBP is a clinical approach to programming that was developed based on physician consultation and case studies. The intent of IBP is to enhance patient outcomes and save time by providing base programming recommendations that you can customize as needed. IBP systematically presents the specific features intended for use with the clinical conditions you identify in the IBP user interface, and allows you to take maximum advantage of the pulse generator’s capabilities. IBP can be accessed from the Settings tab on the main application screen (Figure 1-2 on page 1-11).

Figure 1-2.

Indications-based Programming screen

Indications are clustered in general categories as illustrated above. The intent for each category of indications is described below: •

Sinus Node: –

If Normal is selected, the intent is to promote intrinsic atrial events and provide RV pacing when necessary.

–

If Chronotropically Incompetent is selected, the intent is to provide rate-adaptive pacing.

–

If Sick Sinus Syndrome is selected, the intent is to provide atrial pacing support.

1-12

USING THE PROGRAMMER/RECORDER/MONITOR INDICATIONS-BASED PROGRAMMING (IBP)

•

AV Node: –

If Normal or 1st Degree Block is selected, the intent is to promote intrinsic AV conduction and provide RV pacing when necessary.

–

If 2nd Degree Block is selected, the intent is to promote intrinsic AV conduction and provide AV sequential pacing when conduction is not present.

–

If Complete Heart Block is selected, the intent is to provide AV sequential pacing.

NOTE: The selected settings for AF and Sinus Node may affect the suggested value for the Normal/1st Degree Block setting of AV Node. •

•

Atrial Arrhythmias –

If Paroxysmal/Persistent is selected, the intent is to avoid tracking atrial arrhythmias by using ATR Mode Switch when a dual-chamber pacing mode is suggested.

–

If Permanent/Chronic AF is selected, the intent is to provide rate adaptive RV pacing.

Ventricular Arrhythmias –

–

–

When History of VF/SCD or Prophylaxis for VT/VF is selected, a 2-zone configuration with the following rate thresholds and therapies is provided: –

180 min-1 for the VF zone with QUICK CONVERT ATP and Maximum Energy Shocks enabled

–

160 min-1 for the VT zone with therapy disabled (Monitor Only)

When History of VT/VF is selected, a 2-zone configuration with the following rate thresholds and therapies is provided: –

200 min-1 for the VF zone with QUICK CONVERT ATP and Maximum Energy Shocks enabled

–

160 min-1 for the VT zone with ATP and Maximum Energy Shocks enabled

–

Rhythm ID enabled

When VF Only is selected, the intent is for a single VF zone of 220 min-1 is provided with only Maximum Energy Shocks enabled.

When you have chosen the patient indications, select the View Recommended Settings button to view a summary of the programming recommendations (Figure 1-3 on page 1-13). NOTE: You must view the settings before you can program them. Selecting the View Recommended Settings button allows you to view the settings that are recommended based on the indications that you selected. Viewing the recommended settings does not overwrite any pending (i.e., not yet programmed) parameter changes. You must choose to program or reject the recommended settings after viewing them. If you choose to reject the recommended settings, all of your pending settings will be restored. If you choose to program the recommended settings, any pending parameter changes will be overwritten, with the exception of sensitivity, shock outputs, and pacing outputs, which are independent of IBP.

USING THE PROGRAMMER/RECORDER/MONITOR MANUAL PROGRAMMING

1-13

Primary Settings Summary

Figure 1-3.

Proposed Settings Summary screen

The Proposed Settings Summary screen displays the primary programming recommendations. Additional details about all changed parameters are available by selecting the View Changes button from the toolbar. You have the option to program the proposed settings or reject them, as long as telemetry is still engaged: •

Program-select the Program this Profile button to accept the proposed settings.

•

Reject-select the Reject this Profile button to reject the proposed settings; this action will return you to the main IBP screen with no changes made.

MANUAL PROGRAMMING Manual programming controls such as sliders and menus are available to allow you to individually adjust pulse generator program settings. Manual programming controls are located on the Settings Summary tab, which can be accessed from the Settings tab or by selecting the Settings Summary button on the Summary tab. Refer to other feature descriptions in this manual for specific manual programming information and instructions. Refer to "Programmable Options" on page A-1 for detailed listings of available settings.

DIVERT THERAPY When the pulse generator is charging to deliver a shock, the shock delivery may be diverted from the patient. If diverted, the shock does not count as one of the total number of shocks that may be delivered during an episode. If redetection occurs and more shock therapy is required, and if more shocks are available in the therapy prescription, the pulse generator will charge again to deliver subsequent shocks. Also, the DIVERT THERAPY key can be pressed to divert ATP therapy in midburst. If redetection occurs, the ATP scheme will not be used again and the next programmed therapy in the sequence will be initiated. 1. If you are not already in a session, position the telemetry wand within range of the pulse generator. 2. Press the DIVERT THERAPY key. A message window will appear indicating that a divert attempt is being made. 3. If using wanded telemetry, maintain the wand position until the message window disappears, indicating the shock has been diverted. Prematurely removing the wand (breaking the telemetry link) may allow the pulse generator to continue charging and to deliver the shock.