INSIGNIA I Ultra MODELS 1190 & 1290 & 1291 System Guide

ABOUT THIS MANUAL This pacemaker system guide can be used with all INSIGNIA I Ultra pacing systems. These pacemakers are used with the Model 2892 CONSULT Software Application and the ZOOM LATITUDE Programming System, which includes the Model 3120 Programmer/Recorder/Monitor (PRM). Refer to the PRM Operator’s Manual for full instructions.

Manual Conventions Throughout this manual, the following text conventions will be used: PRM KEYS

The names of the PRM keys will appear in capital letters (e.g., PROGRAM, INTERROGATE).

Screen Text

When text appearing on the PRM screen is referred to in the manual, it will appear with the first letter of each word capitalized.

1., 2., 3.

Numbered lists indicate a series of instructions that should be followed in the order given.

•

Bullets precede items in a list, or a series that is not sequential. A pacemaker profile appears in the margin if the feature being discussed applies only to a specific type of pacemaker (e.g., DR). If the feature applies to all models, there will be no profile.

This manual uses two graphic representations to help the reader locate features on the PRM. As each PRM screen is introduced, a graphic of the PRM toolbox button bar indicates the button to be selected. In the following example, the Temporary Parameters button on the toolbox button bar is shaded, indicating the PRM screen being discussed in that section. AutoLifestyle, INSIGNIA I Ultra, LATITUDE, Quick Notes, Quick Start, and ZOOM are trademarks of Guidant Corporation.

Temporary Parameters Screen

In the following example, the graphic shows that the Rate Smoothing parameter is found by accessing the Rate Enhancements submenu from the Brady Parameters screen.

Rate Smoothing Brady Parameters

Rate Enhancements

All screen illustrations in this manual show typical screens from an INSIGNIA I Ultra Model 1290 pacemaker. The screens you see when interrogating or programming other pacemaker models will be similar but may not include any dual-chamber fields, depending on the model. In this manual, “select” means to touch the stylus to the desired item on the screen. Menu buttons and parameter selection buttons will activate when touched; the buttons in the parameter value palettes will activate when the stylus is lifted from the screen.

Other Related Manuals and Information Tools The Physician’s Technical Manual is packaged with the pacemaker and provides the information needed to implant the pacemaker at nominal parameter settings. All information in the Physician’s Technical Manual is also included in this manual. The ZOOM Programming System Operator’s Manual provides information specific to the PRM, such as setting up the system, maintenance, and handling. The Lead Manuals provide specific information and instructions regarding the implanted lead(s).

Symbols on Packaging The following symbols may be used on pulse generator packaging and labeling (Table 1):

Table 1. Symbols on packaging Symbol

Definition Opening instructions

Wand placement indicator

CONTENTS REFERENCE TABLES... I Nominal Mechanical Specifications... i X-ray Identifier... i Longevity Projections (Years)... ii Magnet Test and Battery Operation... iv Features List... iv INFORMATION FOR USE... 1-1 CHAPTER 1 Device Description... 1-2 INDICATIONS FOR USE... 1-2 CONTRAINDICATIONS... 1-3 Warnings and Precautions... 1-4 MV Sensor Calibration at Implant... 1-4 Clinical Considerations... 1-4 Sterilization, Storage, and Handling... 1-5 Lead Evaluation and Connection... 1-6 Implantation... 1-7 Programming and Pacemaker Operation... 1-7 MV Initialization... 1-8 Environmental and Medical Therapy Hazards... 1-8 Explanted Pacemakers... 1-12 ADVERSE EVENTS... 1-12 Observed Adverse Events... 1-12 Potential Adverse Events... 1-15 SUMMARY OF CLINICAL STUDIES... 1-16 Clinical Study, INSIGNIA I Ultra... 1-16 Conclusions... 1-19 Clinical Studies, Adaptive Rate Therapy PULSAR MAX... 1-20 Clinical Study, Auto Sense... 1-25 Product Reliability... 1-26 Federal Communications Commission (FCC)... 1-27 Patient Counseling Information... 1-27 Patient Handbook... 1-28

Patient Identification (ID) Card... 1-28 PRE-IMPLANT AND IMPLANT INFORMATION... 2-1 CHAPTER 2 Storage... 2-2 Opening Instructions... 2-2 Items Included... 2-3 Sterilization... 2-3 Lead Connections... 2-3 Lead Adapters... 2-4 Lead-to-Pacemaker Connection... 2-5 Pacemaker Insertion... 2-7 Automatic Lead Implant Detection... 2-7 Pacemaker Insertion Procedure... 2-9 TECHNICAL INFORMATION... 3-1 CHAPTER 3 Adaptive-Rate Sensors... 3-2 Accelerometer... 3-2 Minute Ventilation (MV)... 3-2 X-Ray Identifier... 3-4 Minimizing Pacemaker / ICD Interaction... 3-4 External Defibrillation Protection... 3-6 Reset... 3-7 Pacing Output... 3-8 Output Recharge Circuit Cycle... 3-9 Runaway Protection... 3-9 POSTIMPLANT INFORMATION... 4-1 CHAPTER 4 Power Source... 4-2

Pacemaker Longevity Projections... 4-2 Battery Status... 4-5 Magnet Test... 4-5 Elective Replacement Near (ERN)... 4-5 Elective Replacement Time (ERT) Operation... 4-6 End-of-Life (EOL) Operation... 4-7 Explant Information... 4-8 Warranty Information... 4-8 USING THE PROGRAMMER / RECORDER / MONITOR (PRM)... 5-1 CHAPTER 5 Starting Up the PRM and Software... 5-2 ECG Display... 5-4 Quick Start... 5-5 The Utilities Menu on the Startup Screen... 5-6 The Select PG Option on the Startup Screen... 5-8 Introduction to Software Terminology and How to Move Around... 5-9 Utilities Button and Screen Icons... 5-9 Logos... 5-12 ECG/EGM Display... 5-13 Toolbox Buttons... 5-13 General Window Functions... 5-13 PRM Keys... 5-14 Programming and Interrogation... 5-15 Establishing Telemetry Communication... 5-15 Interrogating the Pacemaker... 5-16 Changing Parameter Values... 5-17 Programming the Pacemaker... 5-18 The Utilities Menu on the Main Application Screen... 5-19 Patient Data... 5-19 Save All to Disk... 5-20 Copy Disk Format Disk Set Programmer Clock... 5-21 About... 5-21 Print Memory... 5-21 New Patient... 5-21

Quit... 5-22 THERAPY... 6-1 CHAPTER 6 Brady Parameters Screen... 6-2 Brady Parameters Submenus... 6-2 Modifying Parameter Values... 6-3 The Cancel Changes Button... 6-3 The Load Nominals Button... 6-3 The Load Initial Values Button... 6-4 BASIC BRADY PARAMETERS-

... 6-5

Mode... 6-5 A-Tachy Response... 6-7 Lower Rate Limit (LRL)... 6-7 Max Tracking Rate (MTR)... 6-8 Conventional DDD Behavior... 6-8 Max Sensor Rate... 6-10 AV Delay (paced)... 6-11 Pulse Width... 6-11 Amplitude... 6-12 Automatic Capture... 6-12 Commanded Ventricular Automatic Threshold Measurement... 6-14 Ambulatory Ventricular Automatic Threshold Measurement... 6-15 Automatic Capture Retry... 6-16 Sensitivity... 6-17 Auto Sense... 6-18 Refractory Periods... 6-19 Atrial Refractory Period... 6-20 Post-Ventricular Atrial Refractory Period (PVARP)... 6-20 Ventricular Refractory Period... 6-21 Pace/Sense... 6-21

SENSOR SUBMENU-

... 6-22

Adaptive-Rate Pacing... 6-22 Accelerometer... 6-22 Response Factor (Accelerometer)... 6-23 Advanced Accelerometer Parameters... 6-25 Minute Ventilation (MV)... 6-29 Response Factor (Minute Ventilation)... 6-31 Advanced Minute Ventilation Parameters... 6-33 Dual-Sensor Blending... 6-34 Time Dependent Blend... 6-37 AutoLifestyle... 6-38 Automatic Response Factor Adjustment (MV)... 6-38 MV Max Long Term... 6-39 On with Exercise... 6-40 Sensor Rate Target for AutoLifestyle... 6-40 Expert Ease/AutoLifestyle... 6-41 A-TACHY RESPONSE-

... 6-42

A-Tachy Response (ATR)... 6-42 Trigger Rate... 6-42 Entry Count... 6-43 Exit Count... 6-43 Duration... 6-45 Fallback Mode... 6-45 Fallback Time... 6-45 ATR Lower Rate Limit... 6-46 Ventricular Rate Regulation (VRR)... 6-47 VRR Max Pacing Rate... 6-48 Atrial Flutter Response (AFR)... 6-48 PMT Termination... 6-49 RATE ENHANCEMENTS SUBMENU-...

6-50

Rate Hysteresis... 6-50 Hysteresis Offset... 6-50 Rate Hysteresis in Nonadaptive-Rate Modes... 6-51

Rate Hysteresis in Adaptive-Rate Modes... 6-51 Search Hysteresis... 6-52 Rate Smoothing... 6-53 Rate Smoothing Up... 6-55 Rate Smoothing Down... 6-55 Max Pacing Rate (DDI and SSI)... 6-56 Rate Smoothing Example... 6-56 Sudden Brady Response (SBR)... 6-57 SBR Detect Time... 6-58 SBR Number of Beats... 6-58 SBR Therapy Rate Offset... 6-58 SBR Therapy Duration... 6-59 SBR MV Offset... 6-59 LEAD CONFIGURATION SUBMENU-

... 6-62

Bipolar Configuration Lock-Out... 6-62 Lead Configuration... 6-62 Pacing Configuration... 6-63 Sensing Configuration... 6-63 Safety Switch (Automatic Lead Configuration)... 6-63 AV DELAY SUBMENU-

... 6-65

Dynamic AV Delay... 6-65 Maximum AV Delay... 6-66 Minimum AV Delay... 6-67 Sensed AV Offset... 6-67 Sensed AV Offset to Fixed AV Delay... 6-68 Sensed AV Offset to Dynamic AV Delay... 6-68 AV Search Hysteresis... 6-68 AV Search Interval... 6-69 AV Increase... 6-69 REFRACTORY SUBMENU-... 6-71 Dynamic PVARP... 6-71 Maximum PVARP... 6-72 Minimum PVARP... 6-72

PVARP after PVC/PAC... 6-72 Blanking and Noise Rejection... 6-73 V-Blanking after A-Pace (Ventricular Blanking)... 6-74 A-Blanking after V-Pace (Atrial Blanking)... 6-75 Noise Rejection... 6-75 MAGNET SUBMENU-...

6-77

Magnet Response... 6-77 DIAGNOSTICS AND FOLLOW-UP... 7-1 CHAPTER 7 System Summary... 7-2 Quick Check Screen... 7-3 Intrinsic Amplitude Measurement... 7-4 Lead Impedance Measurement... 7-4 Atrial and Ventricular Amplitude Threshold Test... 7-5 Print Quick Notes... 7-7 Full Report... 7-7 Save All to Disk... 7-7 Reset Counters... 7-7 Brady Parameters Screen... 7-7 Temporary Parameters Screen... 7-7 Implementing Temporary Values... 7-9 Setup... 7-10 Magnet... 7-10 Arrhythmia Logbook... 7-10 Trending... 7-13 Daily Measurement... 7-15 Therapy History... 7-15 Arrhythmia Logbook... 7-15 Counters... 7-19 Histograms... 7-22 Diagnostic Evaluation... 7-23 Battery Status... 7-23 Intrinsic Amplitude Test... 7-25 Threshold Tests... 7-28

Activity Log... 7-33 Daily Measurement... 7-34 Trending... 7-38 Snapshot Viewer... 7-41 EP Test... 7-43 Atrial Stimulation and Backup VVI Pacing During EP Testing... 7-44 Programmed Electrical Stimulation (PES)... 7-44 Manual Burst Pacing... 7-46 ELECTROGRAMS (EGMS) / EVENT MARKERS / REPORTS... 8-1 CHAPTER 8 Viewing and Printing Real-Time Traces and Markers... 8-2 Displaying Surface ECGs, EGMs, and Event Markers... 8-3 Printing to the Internal PRM Printer/Recorder... 8-5 Printing to an External Printer... 8-8 Printing to an External Recorder... 8-9 Obtaining a Printed Report... 8-9 PACEMAKER MODES OF OPERATION... A-1 APPENDIX A Pacemaker Identification Codes... A-1 Optimal Pacing Mode Decision Tree... A-2 Available Modes... A-2 DDD(R) Mode... A-3 DDI(R) Mode... A-3 DOO(R) Mode... A-4 VDD Mode... A-5 AAI(R) Mode... A-5 VVI(R) Mode... A-6 AOO(R) Mode... A-6 VOO(R) Mode... A-7 AAT Mode... A-8 VVT Mode... A-9 EXTERNAL CABLE CONNECTIONS... B-1 APPENDIX B Surface ECG Connections... B-2 Troubleshooting... B-6

Optimizing the Quality of ECG Tracings... B-6 PROGRAMMABLE PACING PARAMETERS AND SPECIFICATIONS... C-1 APPENDIX C

REFERENCE TABLES Nominal Mechanical Specifications Modela

Type

Dimensions WxHxD (mm)

Volume (cc)

Mass (g)

Connector

1190

SSIR

42 x 42 x 8

10.0

23.4

IS-1b only

1290

DDDR

42 x 44 x 8

10.8

25.4

IS-1 only

1291

DDDR

43 x 49 x 8

12.6

29.6

3.2-mm or IS-1c

a. All devices use a size 2 hex wrench. b. IS-1 refers to the international standard ISO 5841.3:1992. c. Accepts IS-1 or 3.2-mm unipolar/bipolar leads.

X-ray Identifier The pacemakers have an identifier located on the header of the device that is visible on x-ray film or under fluoroscopy. This provides noninvasive confirmation of the manufacturer. The identifier for INSIGNIA I devices consists of the letters “GDT” to identify the manufacturer (Guidant). The letters are followed by “003” to identify the Model 2892 software application needed to communicate with the pacemaker. Refer to the Quick Start section (page 5-5) for information on identifying the device via the programmer. The model number of the pacemaker is stored in the device's memory and is available on the About screen selectable through the Utilities menu when the pacemaker is interrogated.

ii

Longevity Projections (Years)a b (Sheet 1 of 2) Models Amplitude and Pacing 1190

1290

1291

350 Ω

6.8

4.9

7.0

500 Ω

7.3

5.4

7.7

750 Ω

7.8

6.0

8.5

1000 Ω

8.1

6.4

9.0

350 Ω

7.9

6.2

8.8

500 Ω

8.2

6.6

9.3

750 Ω

8.5

7.0

9.9

1000 Ω

8.7

7.3

10.2

350 Ω

7.4

5.6

7.9

500 Ω

7.8

6.0

8.5

750 Ω

8.2

6.5

9.2

1000 Ω

8.4

6.9

9.7

350 Ω

8.3

6.7

9.5

500 Ω

8.5

7.0

9.9

750 Ω

8.8

7.3

10.4

1000 Ω

8.9

7.5

10.6

A and V Amplitudes 3.5 V 100% Paced

50% Paced

A and V Amplitudes 2.5 V 100% Paced

50% Paced

iii

Longevity Projections (Years)a b (Sheet 2 of 2) Models Amplitude and Pacing 1190

1290

1291

Automatic Capture On (A= 3.5 Vc, V= 1.0 [assuming a threshold of 0.5]) 100% Paced 350 Ω

8.9

6.0

8.4

500 Ω

8.9

6.3

9.0

750 Ω

9.0

6.8

9.5

1000 Ω

9.0

7.0

9.9

350 Ω

9.0

6.9

9.7

500 Ω

9.1

7.2

10.1

750 Ω

9.1

7.4

10.4

1000 Ω

9.1

7.6

10.7

50% Paced

Automatic Capture On (A= 2.5 Vc, V= 1.0 [assuming a threshold of 0.5]) 100% Paced 350 Ω

8.9

6.4

9.1

500 Ω

8.9

6.7

9.5

750 Ω

9.0

7.1

10.0

1000 Ω

9.0

7.3

10.3

350 Ω

9.0

7.2

10.2

500 Ω

9.1

7.4

10.4

750 Ω

9.1

7.6

10.7

1000 Ω

9.1

7.7

10.9

50% Paced

a. Amplitudes shown are both atrial and ventricular; pulse width = 0.4 ms, pacing rate = 60 ppm, sensors = On. b. Table displays typical parameter settings and the corresponding longevities from implant to ERT for all pacemaker models. Longevity can be greatly influenced by parameter settings. c. This value is not applicable in single-chamber devices.

iv

Magnet Test and Battery Operation Magnet Ratea

Battery Status

Comments

100 ppm

BOL (Beginning of Life)

Perform normally scheduled follow-ups.

90 ppm

ERN (Elective Replacement Near)

Intensify follow-ups.

85 ppm

ERT (Elective Replacement Time)

Schedule replacement. Beat-to-Beat ventricular Automatic Capture is disabled and ventricular output is fixed at twice the last measured threshold but not > 5.0 V and not < 3.5 V. For adaptive-rate modes only: When the pacemaker reaches ERT, the mode will change to nonadaptive rate mode (e.g., DDDR to DDD, VVIR to VVI, etc)

85 ppm or less

EOL (End of Life)

Three months after ERT, the device will reach EOL. When EOL is reached, dual-chamber pacemakers will change modes to single-chamber operation (DDD and VDD revert to VVI) and the LRL will be lowered to 50 ppm. Schedule replacement immediately.

a. To perform a battery test using the magnet, the magnet operation must be programmed to Async. The AV Delay during a magnet test is 100 ms. When Automatic Capture is programmed Off, the third pulse of the magnet test is at 50% of the programmed Pulse Width to allow evaluation of the pacing safety margin.

Features List Refer to Chapter 6, “Therapy” and Chapter 7, “Diagnostics and Follow-Up” for complete descriptions of the features. Diagnostic Features •

Autothreshold (Commanded and Ambulatory)

•

Interactive P- and R-Wave Amplitude measurements

•

Interactive A and V Lead Impedance measurements

•

Event Counters

•

Sensor trending

•

Patient Activity Log

•

Rate Histograms

•

Real-time intracardiac EGMs

•

Annotated Event Markers

•

Automatic Stored EGM

•

Patient-Triggered Stored EGM

v •

High-Resolution Rate and Sensitivity trending

•

Beat-to-Beat Holter

•

Arrhythmia Logbook

•

Daily P- and R-Wave Amplitude measurements and trend

•

Daily A and V Lead Impedance measurements and trend

•

Daily V Automatic Capture threshold measurements and trend

•

Quick Check

Therapy Features •

Ventricular Automatic Capture

•

AutoLifestyle

•

Adaptive-Rate Sensors • Accelerometer • Minute Ventilation • MV Lead selection • Blended sensor

•

A-Tachy Response

•

Auto Sense

•

Dynamic AV Delay

•

PVARP after PVC/PAC

•

PMT Termination

•

Rate Smoothing

•

Sensed AV Offset

•

(Sensor) Rate Hysteresis

•

Atrial Flutter Response

•

AV Search Hysteresis

•

Dynamic PVARP

•

Programmed Electrical Stimulation/Burst

•

Sudden Brady Response

•

Sudden Brady Response with MV Offset

•

Ventricular Rate Regulation (VRR)

•

Safety Switch

1-1

INFORMATION FOR USE CHAPTER 1 This chapter includes the following information associated with the INSIGNIA I Ultra pacemakers. •

Device Description

•

Indications and Usage

•

Contraindications

•

Warnings and Precautions

•

Adverse Events

•

Summary of Clinical Studies

•

Product Reliability

•

Federal Communications Commission (FCC)

•

Patient Counseling Information

1-2

INFORMATION FOR USE DEVICE DESCRIPTION

DEVICE DESCRIPTION The INSIGNIA I Ultra pacemakers are multiprogrammable. The family consists of both dual-chamber and single-chamber models, offering conventional and adaptiverate therapy and ventricular Automatic Capture, as well as various levels of therapeutic and diagnostic functionality. The ventricular Automatic Capture feature automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above this measured threshold. Following each ventricular pacing output, capture is automatically verified by the pacemaker via sensing of the evoked response. The pacemakers feature IS-11 as well as 3.2-mm/IS-1 connectors. The 3.2-mm/IS-1 connectors accept both IS-1 and 3.2-mm leads. Refer to page iv in the front of the manual for a list of features. Two sensors are available with the INSIGNIA I Ultra adaptive-rate models: minute ventilation (MV) and an accelerometer (motion sensor). MV responds to changes in respiration, and the accelerometer responds to patient activity (motion). The INSIGNIA I Ultra models can use either the accelerometer or the MV sensor, or a blend of both accelerometer and MV. Refer to Chapter 3, “Technical Information” for a detailed description of the sensors.

INDICATIONS FOR USE This pacemaker system is indicated for patients with any of the following conditions: •

Symptomatic paroxysmal or permanent second- or third-degree AV block

•

Symptomatic bilateral bundle branch block

•

Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block)

•

Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

•

Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes

1. IS-1 refers to the international standard ISO 5841.3:1992.