INCEPTA ICD Reference Guide

Page 1

REFERENCE GUIDE

INCEPTA™ ICD

IMPLANTABLE CARDIOVERTER HIGH ENERGY

DEFIBRILLATOR

REF E160, E161, E162, E163

Page 3

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System Guides have been replaced by Reference Guides, and the Physician’s Technical Manual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

ABM

AF

AFib

AFR

AGC

AIVR

Atrial

Autonomic Balance Monitor

Atrial Fibrillation

Atrial Fibrillation

Atrial Flutter Response

Automatic Gain Control

Accelerated Idioventricular Rhythm

The following are trademarks of Boston Scientific or its affiliates: ApneaScan, AUTONOMIC BALANCE MONITOR,

INCEPTA, Onset/Stability, Quick Convert, RHYTHM ID, RhythmMatch, RYTHMIQ, Safety Core, Smart Blanking,

VENTAK, VITALITY, ZIP, ZOOM, ZOOMVIEW.

Page 4

AT

ATP

ATR

AV

BCL

CPR

DFT

EAS

ECG

EF

EGM

EMI

EP

HE

HRV

IBP

ICD

LRL

MI

MPR

MRI

MSR

MTR

NSR

PAC

PAT

PES

PMT

PRM

PSA

PTM

PVARP

PVC

RADAR

RF

RTTE

RV

RVRP

SCD

SDANN

SRD

SVT

TARP

TENS

V

VF

VFib

VRP

VRR

VT

VTR

Atrial Tachycardia

Antitachycardia Pacing

Atrial Tachy Response

Atrioventricular

Burst Cycle Length

Cardiopulmonary Resuscitation

Defibrillation Threshold

Electronic Article Surveillance

Electrocardiogram

Ejection Fraction

Electrogram

Electromagnetic Interference

Electrophysiology; Electrophysiologic

High Energy

Heart Rate Variability

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

Standard Deviation of Averaged Normal-to-Normal R-R intervals

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

Page 6

Ventricular Redetection.................................................................................................. 2-9

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 .............................................................

Burst Parameters ...........................................................................................................

Coupling Interval and Coupling Interval Decrement ......................................................

Burst Cycle Length (BCL) ............................................................................................

Minimum Interval..........................................................................................................

Burst Scheme ..............................................................................................................

Ramp Scheme .............................................................................................................

Scan Scheme...............................................................................................................

Ramp/Scan Scheme ....................................................................................................

ATP Pulse Width and ATP Amplitude ..........................................................................

Ventricular ATP Time-out .............................................................................................

QUICK CONVERT ATP ...............................................................................................

3-7

3-8

3-9

3-10

3-10

3-11

3-11

3-12

3-12

3-13

3-13

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

Page 7

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+ ..................................................................................................................

RYTHMIQ ....................................................................................................................

4-24

4-24

4-25

4-26

4-27

Refractory ...........................................................................................................................

A-Refractory (PVARP) .................................................................................................

RV-Refractory (RVRP) .................................................................................................

Cross-Chamber Blanking and Noise Rejection............................................................

4-28

4-28

4-29

4-29

Noise Response .................................................................................................................

4-32

Ventricular Tachy Sensing Interactions...............................................................................

4-33

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 ........................................................................................................................

Heart Rate Variability (HRV) ..........................................................................................

6-7

6-7

6-8

6-9

Trends ................................................................................................................................

6-11

Post Implant features..........................................................................................................

Patient Triggered Monitor.............................................................................................

Sensitivity Adjustment..................................................................................................

Beeper Feature ............................................................................................................

Magnet Feature............................................................................................................

6-13

6-13

6-14

6-14

6-16

Page 8

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

Page 9

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

Page 10

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).

Page 11

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.

Page 12

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).

•

Wireless ECG is a form of real-time EGM that mimics a surface ECG by using a shocking

lead proximal coil to can vector for measuring heart activity. Unless the device is still in

Storage mode, the first (top) trace on the display will default to Wireless ECG.

CAUTION: Wireless ECG is susceptible to RF interference, and may have an intermittent

or lost signal. If interference is present, especially during diagnostic testing, consider using a

surface ECG instead.

NOTE:

Wireless ECGs are only available with dual-coil shock leads.

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

Page 13

USING THE PROGRAMMER/RECORDER/MONITOR

SOFTWARE TERMINOLOGY AND NAVIGATION

•

View pending or programmed changes

•

View attentions and warnings

•

End your PRM session

1-5

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.

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.

Page 14

1-6

USING THE PROGRAMMER/RECORDER/MONITOR

SOFTWARE TERMINOLOGY AND NAVIGATION

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.

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.

Page 15

USING THE PROGRAMMER/RECORDER/MONITOR

DEMONSTRATION MODE

1-7

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).

Table 1-1.

PRM color conventions

Meaning

Color

Red

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.

Page 16

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:

Page 17

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.

Page 18

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.

Page 19

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.

Page 20

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.

Page 21

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.

Page 22

1-14

USING THE PROGRAMMER/RECORDER/MONITOR

STAT SHOCK

NOTE: There is a 500 ms delay between the end of charging and shock delivery designed

to provide a minimum period for the DIVERT THERAPY command. After this time, pressing

DIVERT THERAPY may not divert the shock.

STAT SHOCK

A nonprogrammable, maximum-output STAT SHOCK can be delivered to the patient at any time

during a communication session. The STAT SHOCK can be delivered when the pulse generator’s

Tachy Mode is programmed to any mode. This function does not affect the programmed shock

sequences (lower-energy shocks can be delivered following a STAT SHOCK) and does not count

as one of the total number of shocks in a therapy sequence for a given episode. The output

of the STAT SHOCK is at the maximum-output energy and at the programmed polarity and

waveform; STAT SHOCK is always committed regardless of programmed parameters.

1. If you are not already in a session, position the telemetry wand within range of the pulse

generator.

2. Press the STAT SHOCK key. A message window appears with information about the shock

and instructions to initiate the shock.

3. To initiate the shock, press the STAT SHOCK key again. A different message window

appears indicating that STAT SHOCK is in process. When the shock has been delivered,

the message window disappears.

4. Subsequent high-energy STAT SHOCKS may be delivered by repeating the previous steps.

NOTE:

The STAT SHOCK may be diverted using the DIVERT THERAPY key.

NOTE: Following STAT SHOCK delivery, if the Tachy Mode is programmed to Monitor

Only or Monitor + Therapy, post-shock redetection is initiated (initial detection criteria and

enhancements are not used). If the Tachy Mode is programmed to Monitor + Therapy and

redetection determines that further therapy is required, the programmed sequence of therapy will

be resumed or initiated, including ATP and/or low-energy shocks.

STAT PACE

Emergency bradycardia pacing using the STAT PACE command sets the bradycardia operation

to parameters intended to ensure capture and keep the patient stable.

1. If you are not already in a session, position the telemetry wand within range of the pulse

generator.

2. Press the STAT PACE key. A message window displays the STAT PACE values.

3. Press the STAT PACE key a second time. A message indicates that STAT PACE is being

performed, followed by the STAT PACE values.

4. Select the Close button on the message window.

5. To stop STAT PACE, reprogram the pulse generator.

CAUTION: When a pulse generator is programmed to STAT PACE settings, it will continue to

pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE

parameters will decrease device longevity.

Page 23

USING THE PROGRAMMER/RECORDER/MONITOR

DATA MANAGEMENT

1-15

DATA MANAGEMENT

The PRM system allows you to manage patient and pulse generator data by viewing, printing,

storing, or retrieving it. This section describes the PRM data management capabilities.

Patient Information

Information about the patient can be stored in pulse generator memory. The information is

accessible from the Summary screen by selecting the Patient icon. This information includes,

but is not limited to, the following:

•

Patient and physician names

•

Pulse generator serial number

•

Implant date

•

Lead configurations

•

Implant test measurements

The information can be retrieved at any time by interrogating the pulse generator and viewing it

on the PRM screen or printing it as a report.

Data Storage

The PRM system allows you to save pulse generator data to the PRM hard drive or a removable

floppy data disk. Data saved to the PRM can also be transferred to a removable USB pen drive.

Saved pulse generator data includes, but is not limited to, the following:

•

Therapy history

•

Programmed parameter values

•

Trending values

•

HRV

•

Histogram paced/sensed counters

Select the Utilities button, and then select the Data Storage tab to access the following options:

•

Read Disk—allows you to retrieve saved pulse generator data from a floppy disk.

•

Save All—allows you to save pulse generator data to either a floppy disk (disk must be

inserted) or the PRM hard drive (if no floppy disk is detected). Data saved to a floppy disk

can be retrieved using the Read Disk option described above. Data saved to the PRM can

be read, deleted, or exported to a USB pen drive using the USB Data Management utility,

which is accessed from the PRM startup screen. Refer to the PRM Operator’s Manual for

more information about this utility.

NOTE: While the data is being saved, a message on the right-hand side of the System

Status screen indicates where the data is being saved.

Consider the following when storing and retrieving pulse generator data:

•

No more than 400 unique patient records may be saved to the PRM. When a pulse generator

is interrogated, the PRM evaluates if there is already a record on file for this pulse generator,

or if a new record will need to be created. If a new record is needed, and the PRM is at

the 400 record capacity, the oldest record on file will be deleted to create space for the

new patient record.

•

When performing multiple patient checkups, be sure to start a new session for each patient.

Page 24

1-16

USING THE PROGRAMMER/RECORDER/MONITOR

SAFETY MODE

•

Be sure to save all pulse generator data to either a floppy disk or USB pen drive before

returning a PRM to Boston Scientific, as all patient and pulse generator data will be erased

from the PRM when it is returned.

•

To protect patient privacy, pulse generator data is encrypted before it is transferred to

removable media.

Device Memory

The Device Memory utility allows you to retrieve, save, and print pulse generator memory data,

which is intended for use by a Boston Scientific representative for clinical and troubleshooting

purposes. This utility should only be used when directed by a Boston Scientific representative.

Digital media with device memory data contains protected health information and therefore

should be handled in accordance with applicable privacy and security policies and regulations.

NOTE: Use the Data Storage tab to access pulse generator data for clinician use ("Data

Storage" on page 1-15).

Print

You can print PRM reports by using the internal printer, or by connecting to an external printer.

To print a report, select the Reports button. Then select the report you wish to print from the

following categories:

•

Follow-up reports

•

Episode reports

•

Other reports (includes device settings, patient data, and other information)

SAFETY MODE

The pulse generator is equipped with a Safety Mode feature, which includes dedicated safety

core circuitry and is intended to provide life-sustaining therapy in the event of specific failures

with in the device.

If the pulse generator experiences a nonrecoverable fault, Safety Mode will be permanently

activated, and the following will occur:

•

The pulse generator will beep 16 times every 6 hours. This beeping is disabled once the

device has been interrogated with a PRM.

•

ZIP telemetry is unavailable when Safety Mode is active; wanded telemetry must be used

instead.

•

Upon interrogation, a warning screen is displayed indicating that the pulse generator is in

Safety Mode, and directing you to contact Boston Scientific.

Backup Pacemaker

The Safety Mode feature provides a simple VVI pacemaker programmed to 72.5 min-1, with

the following output characteristics.

•

Pulse Amplitude—5 V

•

Pulse Width—1.0 ms

Additionally, the following parameters are fixed while Safety Mode is activated:

•

RV lead configuration—Unipolar

Page 25

USING THE PROGRAMMER/RECORDER/MONITOR

SAFETY MODE

•

RV Refractory Period (RVRP)—250 ms

•

Noise Response—VOO

1-17

Backup Defibrillator

The Safety Mode feature provides a single-zone backup defibrillator, which can be enabled

or disabled using the PRM.

Tachycardia Detection in Safety Mode

In Safety Mode, the tachycardia detection monitors RV senses using a traditional tachycardia

detection window with a rate threshold of 165 min-1 and Duration of 1 second.

Tachycardia Therapy in Safety Mode

In Safety Mode, tachycardia therapy consists of maximum energy, committed shocks, with

the following settings:

•

Shock polarity—initial

•

Shock waveform—biphasic

•

Shock vector—V-TRIAD

Within the period of a declared episode, therapy is limited to 5 shocks. Also, Post-Shock Pacing

Delay is fixed at 3 seconds.

When a magnet is detected, therapy delivery is immediately inhibited although charging may

continue. After the magnet has been applied for 1 second, the therapy is diverted and detection

is inhibited. The magnet must then be removed for 2 seconds in order to allow detection to

continue. Also, Safety Mode disables normal beeping behavior following magnet application.

Programming the Device Safety Tachy Mode

In Safety Mode, you can perform the following steps to program the Safety Tachy Mode:

1. Select the Tachy Mode button. The Change Device Mode dialog displays.

2. Click to select the required Safety Tachy Mode setting, either Off or Monitor + Therapy. Click

Apply Changes to apply the new setting, or Cancel Changes to cancel the new setting.

3. Click Close to dismiss the Change Device Mode dialog.

NOTE: The safety tachy mode automatically will be set to Off if additional faults are detected

while in Safety Mode.

Page 26

1-18

USING THE PROGRAMMER/RECORDER/MONITOR

SAFETY MODE