Advantio Reference Guide

ABOUT THIS MANUAL This family of implantable pacemakers contains both single- and dual-chamber pulse generators that provide atrial and/or ventricular pacing and sensing 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 System Guides have been replaced by Reference Guides, and the Physician’s Technical Manual has been expanded. 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. NEW OR ENHANCED FEATURES These pulse generator systems include additional or enhanced features as compared to previous Boston Scientific pacemakers. The list below is intended to highlight some of these features, it is not a comprehensive list. Please refer to the feature-specific content elsewhere in this manual for detailed descriptions of these features. User Experience •

Hardware: the number of setscrews has been reduced to one setscrew per port

•

ZIP Telemetry: provides wandless, two-way RF communication with the pulse generator

•

ZOOMVIEW Programmer Software: the new user interface is consistent across Boston Scientific brady, tachy, and heart failure devices.

•

Single Chamber Devices: incorporates programmability to select atrial or ventricular specific modes

•

USB storage devices are supported: pulse generator data can be saved and transferred to a USB pen drive

Tachy Detection •

Ventricular Tachy EGM Storage utilizes the strengths of an ICD-based tachycardia detection strategy including a V > A detection enhancement

Brady Therapy •

New brady modes available include VDDR and Off

•

AV Search+: designed to reduce unnecessary RV pacing for patients with intact or intermittent AV conduction by allowing intrinsic AV conduction beyond the programmed AV delay during episodes of normal AV nodal function

•

RightRate Pacing: utilizes minute ventilation to provide rate adaptive pacing based on physiologic changes along with automatic calibration, a simplified user interface, and filtering designed to mitigate MV interactions

•

Safety Core: safety architecture is utilized to provide basic pacing if non-recoverable or repeated fault conditions occur

The following are trademarks of Boston Scientific or its affiliates: ADVANTIO, PaceSafe, PULSAR, QUICK NOTES, RightRate, Safety Core, Smart Blanking, ZIP, ZOOM, ZOOMVIEW.

•

Electrocautery Protection: provides asynchronous pacing operation at the LRL

Sensing •

Automatic gain control (AGC): dynamically adjusts sensitivity in both the atrium and ventricle

•

Smart Blanking: used in conjunction with AGC sensing to promote appropriate cross-chamber sensing capabilities

Patient Diagnostics •

Trends: expanded set of trends is provided including: –

Heart Rate

–

Atrial burden (including total number of episodes)

–

Events

•

Average V Rate in ATR: provides the average ventricular rate during ATR episodes

•

Arrhythmia Logbook: memory is allocated between numerous episode types with increased data storage available

•

Lead Safety Switch: diagnostic information is provided to show the date and impedance value which caused the LSS

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 AGC AT ATP ATR

Atrial Atrial Fibrillation Automatic Gain Control Atrial Tachycardia Antitachycardia Pacing Atrial Tachy Response

AV BPEG CPR EAS ECG EF EGM EMI EP ICD LRL MI MPR MRI MSR MTR MV NASPE NSR NSVT PAC PAT PES PMT PRM PSA PTM PVARP PVC RADAR RF RTTE RV RVAC RVRP SCD SVT TARP TENS V VF VRP VT

Atrioventricular British Pacing and Electrophysiology Group Cardiopulmonary Resuscitation Electronic Article Surveillance Electrocardiogram Ejection Fraction Electrogram Electromagnetic Interference Electrophysiology; Electrophysiologic Implantable Cardioverter Defibrillator Lower Rate Limit Myocardial Infarction Maximum Pacing Rate Magnetic Resonance Imaging Maximum Sensor Rate Maximum Tracking Rate Minute Ventilation North American Society of Pacing and Electrophysiology Normal Sinus Rhythm Nonsustained Ventricular Tachycardia 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 Automatic Capture Right Ventricular Refractory Period Sudden Cardiac Death Supraventricular Tachycardia Total Atrial Refractory Period Transcutaneous Electrical Nerve Stimulation Ventricular Ventricular Fibrillation Ventricular Refractory Period Ventricular Tachycardia

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 1-5 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 1-8 1-9

Manual Programming ...

1-11

DIVERT THERAPY ...

1-11

STAT PACE ...

1-11

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

1-12 1-12 1-12 1-13 1-13

Safety Mode ... Backup Pacemaker...

1-13 1-14

PACING THERAPIES ... CHAPTER 2

2-1

Pacing Therapies...

2-2

Device Modes... Electrocautery Protection Mode...

2-2 2-2

Basic Parameters ... 2-3 Brady Mode... 2-3 Lower Rate Limit (LRL) ... 2-6 Maximum Tracking Rate (MTR) ... 2-7 Maximum Sensor Rate (MSR) ... 2-9 Runaway Protection... 2-10 Pulse Width... 2-10 Amplitude ... 2-10 PaceSafe ... 2-11 Sensitivity... 2-14 Temporary Brady Pacing ...

2-18

Rate Adaptive Pacing and Sensor Trending ... Rate Adaptive Pacing ... Accelerometer... Minute Ventilation (MV)... Sensor Trending...

2-19 2-19 2-19 2-23 2-31

Atrial Tachy Response... ATR Mode Switch ... PMT Termination...

2-33 2-33 2-35

Rate Enhancements ... Rate Hysteresis... Rate Smoothing ... Rate Smoothing Example Based on a Dual-Chamber Tracking Mode ...

2-37 2-37 2-38 2-39

Lead Configuration ... Use of Atrial Information ... Lead Safety Switch ...

2-40 2-41 2-42

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

2-42 2-43 2-44 2-45

Refractory ... A-Refractory - PVARP... A Refractory - same chamber ... RV-Refractory (RVRP) ... Cross-Chamber Blanking...

2-46 2-47 2-47 2-48 2-49

Noise Response ...

2-52

SYSTEM DIAGNOSTICS... CHAPTER 3

3-1

Summary Dialog ...

3-2

Battery Status ...

3-2

Leads Status...

3-6

Lead Tests ... 3-9 Intrinsic Amplitude Test ... 3-9 Lead Impedance Test... 3-10 Pace Threshold Test ... 3-11 PATIENT DIAGNOSTICS AND FOLLOW UP ... CHAPTER 4

4-1

Therapy History ...

4-2

Arrhythmia Logbook ...

4-2

Histograms ...

4-7

Counters ... Ventricular Tachy Counters ... Brady Counters ...

4-7 4-8 4-8

Trends ...

4-8

Post Implant features...

4-10

Patient Triggered Monitor... Magnet Feature...

4-10 4-11

ELECTROPHYSIOLOGIC TESTING... CHAPTER 5

5-1

EP Test Features ... EP Test Screen ...

5-2 5-2

Induction Methods ... Backup Ventricular Pacing During Atrial EP Testing ... Programmed Electrical Stimulation (PES) ... Manual Burst Pacing...

5-3 5-3 5-3 5-5

PROGRAMMABLE OPTIONS... APPENDIX A

A-1

SYMBOLS ON PACKAGING... APPENDIX B

B-1

Symbols on Packaging ...

B-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

•

"Manual Programming" on page 1-11

•

"DIVERT THERAPY" on page 1-11

•

"STAT PACE" on page 1-11

•

"Data Management" on page 1-12

•

"Safety Mode" on page 1-13

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 2869 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 Patient Data Mode without the presence of a pulse generator

•

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

•

Save patient data

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 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: If the PRM is left idle for 15 minutes (or 28 minutes if the pulse generator was in Storage Mode at interrogation) real-time EGMs are shut off. The PRM provides a dialog box allowing real-time EGMs to be restored.

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

•

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

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

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. Action Icons Run-causes the programmer to perform an action.

1-6

USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION

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.

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.

1-7

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.

Indicates acceptable changes or conditions

Green

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. Telemetry is required to: •

Direct commands from the PRM system, such as: –

INTERROGATE

–

PROGRAM

–

STAT PACE

–

DIVERT THERAPY

1-8

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

•

Modify device parameter settings

•

Conduct EP testing

•

Conduct diagnostic tests including the following: –

Pacing impedance tests

–

Pacing threshold tests

–

Intrinsic amplitude tests

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: 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.

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

1-9

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). Communication is supported between two PRMs and two pulse generators at a time, as two independent sessions. If there are two PRM–pulse generator communication sessions already occurring 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.

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

1-10

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

•

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. Repeated displays of this message may indicate the presence of intermittent interference. These situations can be resolved by repositioning the PRM or using standard wanded telemetry. There will be no interruption of device functionality or therapy during this period. NOTE: When both ZIP and wanded telemetry are being used (for example, switching from ZIP to wanded because of the presence of interference), the pulse generator will communicate with the programmer by ZIP telemetry when possible. If wanded telemetry only is desired, ZIP must be programmed Off. NOTE: To conserve battery longevity, a ZIP telemetry session will be terminated if the pulse generator completely loses communication with the PRM for a continuous period of one hour. Wanded telemetry must be used to re-establish communication with the pulse generator after this one hour period has elapsed. NOTE: The PRM operates on a country–specific frequency range. 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 the country in which the pulse generator was implanted. 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. If out-of-country interrogation is needed, contact Boston Scientific using the information on the back cover of this manual. 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. 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

USING THE PROGRAMMER/RECORDER/MONITOR MANUAL PROGRAMMING

1-11

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.

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 The DIVERT THERAPY key can be used to terminate any diagnostic test in progress, as well as Electrocautery Protection Mode (maintain the telemetry wand position until the divert function is complete to avoid interruption to the divert command).

STAT PACE Emergency bradycardia pacing using the STAT PACE command sets the bradycardia operation to parameters intended to ensure capture. 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. NOTE:

STAT PACE will terminate Electrocautery Protection Mode.

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 likely decrease device longevity. The STAT PACE parameter values are listed below (Table 1-2 on page 1-11). Table 1-2.

STAT PACE Parameter Values Parameter

Values

Mode

VVI

Lower Rate Limit

60 min-1

Interval

1000 ms

Amplitude

7.5 V

Pulse Width

1.0 ms

Paced Refractory

250 ms

Lead Configuration (Pace/Sense)

Unipolar

1-12

USING THE PROGRAMMER/RECORDER/MONITOR DATA MANAGEMENT

NOTE: AOO.

STAT PACE pacing mode is AAI for single-chamber devices programmed to AAI(R) or

DATA MANAGEMENT The PRM system allows you to view, print, store, or retrieve patient and pulse generator data. 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 data

•

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. NOTE: If the data for patient date of birth, gender, or fitness level are changed within Patient Information, the corresponding value in Minute Ventilation will automatically change. Likewise, if the data for fitness level is changed within Minute Ventilation, the corresponding value in Patient Information will automatically change.

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

•

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 from the PRM startup screen. Refer to the PRM Operator’s Manual for more information. 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.

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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.

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

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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.

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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 1-12).

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

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Episode reports

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

SAFETY MODE The pulse generator is equipped with dedicated Safety Core hardware that is intended to provide life-sustaining therapy if certain nonrecoverable or repeat fault conditions occur and cause a system reset. These types of faults indicate a loss of component integrity in the pulse generator’s central processing unit (CPU), including the microprocessor, program code, and system memory. Using minimal hardware (i.e., unipolar lead configuration), Safety Core operates independently and acts as a backup to these components. Safety Core also monitors the device during normal pacing; if normal pacing does not occur, Safety Core delivers an escape pace, and a system reset is initiated. If the pulse generator experiences three resets within approximately 48 hours, the device reverts to Safety Mode and device replacement should be considered. The following will also occur: •

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