ALTRUA 50 and 60 Reference Guide

ABOUT THIS MANUAL 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 materials. As we work through the transition, we will continue to offer doctors and their patients technologically advanced and high quality medical devices and therapies. This pacemaker system guide can be used with all ALTRUA 50 and ALTRUA 60 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 (eg, 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 (eg, DR). If the feature applies to all models, there will be no profile. ALTRUA 60

A device name appears in the margin if the feature being discussed applies only to specific pacemaker models (eg, ALTRUA 60). If the feature applies to all models there will be no device listed.

The following trademarks are property of Boston Scientific or its affiliates: ALTRUA, LATITUDE, Quick Notes, Quick Start, AutoLifestyle, and ZOOM.

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.

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 PRM screen illustrations in this manual show typical screens for all models. The screens you see when interrogating or programming other pacemaker models will be similar but may not include any dual-chamber fields or adaptiverate 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 LATITUDE 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 Reference number

Serial number

Use by

Lot number

Date of manufacture

Sterilized using ethylene oxide

Do not reuse

Consult instructions for use Temperature limitation

Table 1. Symbols on packaging

Symbol

Definition Wand placement indicator

Opening instructions

RTTE designation for radio equipment with a use restriction CE mark of conformity with the identification of the notified body authorizing use of the mark

CONTENTS REFERENCE TABLES... I Nominal Mechanical Specifications... i X-ray Identifier... i ALTRUA 60 Longevity Projections (Years)... ii ALTRUA 50 Longevity Projections (Years)... iv Magnet Test and Battery Operation... vi Features List... vi INFORMATION FOR USE... 1-1 CHAPTER 1 Device Description... 1-2 Indications and Usage... 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 Product Reliability... 1-13 Patient Counseling Information... 1-14 Patient Handbook... 1-14 Patient Identification (ID) Card... 1-14 PRE-IMPLANT AND IMPLANT INFORMATION... 2-1 CHAPTER 2 Storage... 2-2 Check EQuipment... 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... 2-8 Automatic Lead Implant Detection... 2-8 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... 4-2 Magnet Test... 4-6 elective replacement near (ERN)... 4-7 Elective Replacement Time (ERT) Operation... 4-7

End-of-Life (EOL) Operation... 4-9 Explant Information... 4-9 Warranty Information... 4-10 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... 5-12 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... 5-21 Format Disk... 5-21 The Set Programmer Clock Utility... 5-22 About... 5-22 Print Memory... 5-22 New Patient... 5-23 Quit... 5-23 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 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... 6-12 Amplitude... 6-12 Automatic Capture... 6-13 Commanded Ventricular Automatic Threshold Measurement... 6-15 Ambulatory Ventricular Automatic Threshold Measurement... 6-15 Automatic Capture Retry... 6-16 Sensitivity... 6-18 Auto Sense... 6-18 Refractory Periods... 6-20 Atrial Refractory Period... 6-20 Post-Ventricular Atrial Refractory Period (PVARP)... 6-21 Ventricular Refractory Period... 6-21 Pace/Sense... 6-22 SENSOR SUBMENU Adaptive-Rate Pacing... 6-23 Accelerometer... 6-24 Response Factor (Accelerometer)... 6-25

Advanced Accelerometer Parameters... 6-27 Automatic Response Factor (Accelerometer)... 6-31 Sensor Rate Target for Automatic Response Factor... 6-32 Accelerometer (Acc) Initial Response Factor... 6-32 Expert Ease /Automatic Response Factor... 6-32 Minute Ventilation (MV)... 6-34 Response Factor (Minute Ventilation)... 6-36 Advanced Minute Ventilation Parameters... 6-38 Dual-Sensor Blending... 6-39 Time Dependent Blend... 6-42 AutoLifestyle... 6-43 Automatic Response Factor Adjustment (MV)... 6-43 MV Max Long Term... 6-44 4-Minute Fast Walk Within 30 Minutes... 6-45 Sensor Rate Target for AutoLifestyle... 6-45 Expert Ease/AutoLifestyle... 6-46 A-TACHY RESPONSE A-Tachy Response (ATR)... 6-47 Trigger Rate... 6-47 Entry Count... 6-48 Exit Count... 6-48 Duration... 6-50 Fallback Mode... 6-50 Fallback Time... 6-50 ATR Lower Rate Limit... 6-51 Ventricular Rate Regulation (VRR)... 6-52 VRR Max Pacing Rate... 6-53 Atrial Flutter Response (AFR)... 6-53 PMT Termination... 6-54 RATE ENHANCEMENTS SUBMENU Rate Hysteresis... 6-55 Hysteresis Offset... 6-55 Rate Hysteresis in Nonadaptive-Rate Modes... 6-56 Rate Hysteresis in Adaptive-Rate Modes... 6-56

Search Hysteresis... 6-57 Rate Smoothing... 6-58 Rate Smoothing Up... 6-60 Rate Smoothing Down... 6-60 Max Pacing Rate (DDI and SSI)... 6-61 Rate Smoothing Example... 6-61 Sudden Brady Response (SBR)... 6-62 SBR Detect Time... 6-63 SBR Number of Beats... 6-63 SBR Therapy Rate Offset... 6-63 SBR Therapy Duration... 6-64 SBR MV Offset... 6-64 Atrial Pacing Preference (APP)... 6-66 APP Search Interval... 6-66 APP Max Pacing Rate... 6-67 LEAD CONFIGURATION SUBMENU Bipolar Configuration Lock-Out... 6-68 Lead Configuration... 6-68 Pacing Configuration... 6-69 Sensing Configuration... 6-69 Safety Switch (Automatic Lead Configuration)... 6-69 AV DELAY SUBMENU Dynamic AV Delay... 6-71 Maximum AV Delay... 6-72 Minimum AV Delay... 6-73 Sensed AV Offset... 6-73 Sensed AV Offset to Fixed AV Delay... 6-74 Sensed AV Offset to Dynamic AV Delay... 6-74 AV Search Hysteresis... 6-74 AV Search Interval... 6-75 AV Increase... 6-75 REFRACTORY SUBMENU

Dynamic PVARP... 6-77 Maximum PVARP... 6-78 Minimum PVARP... 6-78 PVARP after PVC/PAC... 6-78 Blanking and Noise Rejection... 6-79 V-Blanking after A-Pace (Ventricular Blanking)... 6-80 A-Blanking after V-Pace (Atrial Blanking)... 6-81 Noise Rejection... 6-81 MAGNET SUBMENU Magnet Response... 6-83 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... 7-32 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... 8-10 Printing to an External Recorder... 8-10 Obtaining a Printed Report... 8-10 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-7 VOO(R) Mode... A-8 AAT Mode... A-9 VVT Mode... A-10 EXTERNAL CABLE CONNECTIONS... B-1

APPENDIX B Surface ECG Connections... B-2 Troubleshooting... B-6 Optimizing the Quality of ECGS... B-6 PROGRAMMABLE PACING PARAMETERS AND SPECIFICATIONS... C-1 APPENDIX C

REFERENCE TABLES

i

REFERENCE TABLES Nominal Mechanical Specifications Type

Dimensions W x H x D (mm)

Volume (cc)

Mass (g)

Connector

S601

SSIR

42 x 42 x 8

10.0

23.4

IS-1b only

S603c, S605

DDDR

42 x 44 x 8

10.8

25.4

IS-1 only

S602c, S604

DDDR

43 x 49 x 8

12.6

29.6

3.2-mm or IS-1d

S508

SSI

42 x 39 x 8

9.2

21.5

IS-1 only

S504c, S507

VDD

42 x 41 x 8

10.0

23.5

IS-1 only

S503c, S506

DDD

42 x 44 x 8

10.8

25.4

IS-1 only

S501

SSIR

42 x 42 x 8

10.0

23.4

IS-1 only

S502c, S505

DDDR

42 x 44 x 8

10.8

25.4

IS-1 only

Modela ALTRUA 60

ALTRUA 50

a. b. c. d.

All devices use a size 2 hex wrench. IS-1 refers to the international standard ISO 5841.3:1992. Models with 400 ms AV delay. 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 ALTRUA devices consists of the letters “BOS” to identify the manufacturer (Boston Scientific). 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

REFERENCE TABLES

ALTRUA 60 Longevity Projections (Years) (Sheet 1 of 2) Modelsc Amplitude and Pacingab S601

S603d, S605

S602d, S604

500 Ω

6.7

4.8

6.5

750 Ω

7.2

5.4

7.3

1000 Ω

7.6

5.8

7.9

500 Ω

7.8

6.0

8.2

750 Ω

8.1

6.5

8.9

1000 Ω

8.4

6.8

9.3

500 Ω

7.7

5.9

8.1

750 Ω

8.1

6.4

8.7

1000 Ω

8.3

6.7

9.2

500 Ω

8.4

6.9

9.4

750 Ω

8.6

7.2

9.8

1000 Ω

8.8

7.4

10.1

A and V Amplitudes 3.5 V 100% Paced

50% Paced

A and V Amplitudes 2.5 V 100% Paced

50% Paced

REFERENCE TABLES

ALTRUA 60 Longevity Projections (Years) (Sheet 2 of 2) Modelsc Amplitude and Pacingab S601

S603d, S605

S602d, S604

Automatic Capture On [A = 3.5 Ve, V= 1.0 V (assuming a threshold of 0.5 V)] 100% Paced 500 Ω

8.6

5.7

7.8

750 Ω

8.7

6.2

8.5

1000 Ω

8.8

6.5

8.9

500 Ω

8.8

6.7

9.1

750 Ω

8.9

7.0

9.6

1000 Ω

8.9

7.2

9.8

50% Paced

Automatic Capture On [A = 2.5 Ve, V = 1.0 V (assuming a threshold of 0.5 V)] 100% Paced 500 Ω

8.6

6.5

8.8

750 Ω

8.7

6.8

9.3

1000 Ω

8.8

7.0

9.6

500 Ω

8.8

7.2

9.8

750 Ω

8.9

7.4

10.1

1000 Ω

8.9

7.5

10.3

50% Paced

a. Amplitudes shown are both atrial and ventricular; pulse width = 0.4 ms, pacing rate = 60 min-¹, sensors = On. b. Longevities (yrs) at "worst case" settings of 5.0 V, 500 Ω, 1.0 ms are: 2.4 for S601, 0.9 for S603 and S605, and 1.4 for S602 and S604 at pacing rate = 70 min-1 1.8 for S601, 0.7 for S603 and S605, and 1.0 for S602 and S604 at pacing rate = 100 min-1. c. 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. d. Models with 400 ms AV delay. e. This value is not applicable in single-chamber devices.

iii

iv

REFERENCE TABLES

ALTRUA 50 Longevity Projections (Years) (Sheet 1 of 2) Modelsc Amplitude and Pacingab S508

S504d, S507

S503d, S506

S501

S502d, S505

500 Ω

5.9

5.5

5.5

8.1

5.5

750 Ω

6.5

6.0

6.3

8.9

6.3

1000 Ω

7.0

6.4

6.9

9.5

6.9

500 Ω

7.2

6.6

7.2

9.8

7.2

750 Ω

7.6

6.9

7.9

10.4

7.9

1000 Ω

7.9

7.2

8.4

10.7

8.4

500 Ω

7.1

6.5

7.1

9.6

7.1

750 Ω

7.6

6.8

7.8

10.3

7.8

1000 Ω

7.9

7.1

8.2

10.6

8.2

500 Ω

8.0

7.2

8.5

10.8

8.5

750 Ω

8.3

7.5

9.0

11.2

9.0

1000 Ω

8.5

7.6

9.3

11.4

9.3

A and V Amplitudes 3.5 V 100% Paced

50% Paced

A and V Amplitudes 2.5 V 100% Paced

50% Paced

v

REFERENCE TABLES

ALTRUA 50 Longevity Projections (Years) (Sheet 2 of 2) Modelsc Amplitude and Pacingab S508

S504d, S507

S503d, S506

S501

S502d, S505

Automatic Capture On [A = 3.5 Ve, V = 1.0 V (assumes a threshold of 0.5 V)] 100% Paced 500 Ω

8.3

7.4

6.8

11.1

6.8

750 Ω

8.4

7.6

7.5

11.3

7.5

1000 Ω

8.5

7.6

7.9

11.5

7.9

500 Ω

8.6

7.7

8.2

11.5

8.2

750 Ω

8.7

7.7

8.6

11.6

8.6

1000 Ω

8.7

7.8

8.9

11.7

8.9

50% Paced

Automatic Capture On [A = 2.5 Ve, V = 1.0 V (assumes a threshold of 0.5 V)] 100% Paced 500 Ω

8.3

7.4

7.9

11.1

7.9

750 Ω

8.4

7.6

8.4

11.3

8.4

1000 Ω

8.5

7.6

8.7

11.5

8.7

500 Ω

8.6

7.7

8.9

11.5

8.9

750 Ω

8.7

7.7

9.2

11.6

9.2

1000 Ω

8.7

7.8

9.4

11.7

9.4

50% Paced

a. Amplitudes shown are both atrial and ventricular; pulse width = 0.4 ms, pacing rate = 60 min-¹, sensors = On. b. Longevities (yrs) at "worst case" settings of 5.0 V, 500 Ω, 1.0 ms are: 1.8 for S508, 1.7 for S504 and S507, 1.0 for S503 and S506, 2.6 for S501, and 1.0 for S502 and S505 at pacing rate = 70 min-1 1.4 for S508, 1.3 for S504 and S507, 0.7 for S503 and S506, 2.0 for S501, and 0.7 for S502 and S505 at pacing rate = 100 min-1. c. 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. d. Models with 400 ms AV delay e. This value is not applicable in single-chamber devices.

vi

REFERENCE TABLES

Magnet Test and Battery Operation Magnet Ratea

Battery Status

Comments

100 min-¹

BOL (Beginning of Life)

Perform normally scheduled follow-ups.

90 min-¹

ERN (Elective Replacement Near)

Intensify follow-ups.

85 min-¹

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 (eg, DDDR to DDD, VVIR to VVI, etc).

85 min-¹ 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 min-¹. 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