Medtronic 7230B Reference Guide

Reference Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

MARQUIS®VR 7230Cx, 7230B, 7230E

Single Chamber Implantable Cardioverter Defibrillator (VVE–VVIR)

MARQUIS VR 7230Cx, 7230B, 7230E

Reference Manual 0

A guide to the operation and programming of the Model 7230Cx, B, and E Marquis VR Single Chamber Implantable Cardioverter Defibrillator

The following are trademarks of Medtronic:

Active Can, Cardiac Compass, Checklist, Decision Channel, Flashback, GEM, Leadless ECG, Marker Channel, MARQUIS, Patient Alert, Quick Look, QuickLink, RapidRead, T-Shock, Wavelet

Table of contents

Introduction xv

Using this manual xv Contacting technical support xv Customer education xv References xvi Notice xvi

Abbreviations and acronyms xvii

Part I Quick overview

1 Quick reference 3

Physical characteristics 4

Magnet application 8

Longevity projections 9

Replacement indicators 12

Typical charge times 13

High voltage therapy energy 13

Stored data and diagnostics 14

New and enhanced features 17

Lead connection header options 17 Patient management 17 Tachyarrhythmia detection 19 Tachyarrhythmia therapy 20 Bradycardia pacing 20 EP studies 21

2 The Marquis VR system 23

System overview 24

Detecting and treating tachyarrhythmias 25 Treating bradycardia 26 Monitoring for real-time and stored data 26 Conducting electrophysiologic tests 26 Alerting the patient to system events 26

Indications and usage 27

Contraindications 27

Marquis VR 7230Cx, B, and E Reference Manual

Table of contents

Patient screening 27

3 Emergency therapy 29

Delivering emergency therapies 30

Effect on system operation 30 Aborting an emergency therapy 30 On-screen and display panel buttons 31 Temporary parameter values 31 How to deliver emergency 30 joule defibrillation 32 How to deliver emergency cardioversion 32 How to deliver emergency fixed burst pacing 33 How to deliver emergency VVI pacing 33

Part II Device implant and patient follow-up procedures

4 Implanting the ICD 37

Overview 38

Preparing for an implant 38

Equipment for an implant 38 Sterile supplies 39 How to prepare for implanting 39

Replacing an ICD 40

How to explant and replace an ICD 40

Positioning the leads 41

Using transvenous leads 41 Using epicardial leads 41 Surgical incisions 42

Testing sensing and pacing thresholds 43

Parameters 43 Considerations 43

Connecting the leads to the ICD 44

How to connect the lead to the device 47

Testing defibrillation operation and effectiveness 47

High voltage implant values 48 Binary search protocol 48 How to prepare for defibrillation threshold testing 49 How to perform defibrillation threshold testing 50

Positioning and securing the ICD 52

How to position and secure the device 52

Marquis VR 7230Cx, B, and E Reference Manual

Completing the implant procedure 52

How to complete programming the device 53

5 Conducting a patient follow-up session 55

Patient follow-up guidelines 56

Verifying the status of the implanted system 56

Verifying accurate detection and appropriate therapy 57

Considerations 57

Verifying effective bradycardia pacing 58

Considerations 59

Part III Configuring the ICD for the patient

6 Detecting tachyarrhythmias 63

Detection overview 64

Suspending tachyarrhythmia detection 66

Setting up sensing 67

Parameters 67 Considerations 67 How to program sensitivity 69 Details about sensing 69

Detecting VF episodes 71

Parameters 72 Considerations 72 Restrictions 73 How to program VF detection 74 Details about VF detection 74

Detecting VT episodes 76

Parameters 76 Considerations 76 Restrictions 77 How to program VT detection 78 Details about VT detection 78

Detecting FVT episodes 82

Parameters 82 Considerations 82 Restrictions 83 How to program FVT detection 84 Details about FVT detection 84

Table of contents

Marquis VR 7230Cx, B, and E Reference Manual

Table of contents

Detecting tachyarrhythmia episodes with Combined Count 87

Details about Combined Count detection 87

Monitoring episodes for termination or redetection 90

Parameters 90 Considerations 90 How to program redetection parameters 91 Details about episode termination and redetection 91

Enhancing detection with Wavelet 94

Parameters 94 Considerations 95 How to program Wavelet 98 Details about Wavelet 98 Details about Auto Collection 101

Enhancing VT detection with the Onset criterion 103

Parameters 103 Considerations 103 How to program Onset 104 Details about Onset 104

Enhancing VT detection with the Stability criterion 108

Parameters 108 Considerations 108 How to program Stability 109 Details about Stability 109

Detecting prolonged tachyarrhythmias with High Rate Timeout 111

Parameters 111 Considerations 111 How to program High Rate Timeout 112 Details about High Rate Timeout 112

Key ter ms 113

7 Treating tachyarrhythmia episodes 119

Treating VF with defibrillation 120

Parameters 120 Considerations 121 Restrictions 122 How to program VF therapies 122 Details about VF therapy 122

Treating VT and FVT with antitachycardia pacing 130

Parameters for all ATP therapies 130

Marquis VR 7230Cx, B, and E Reference Manual

Table of contents

Parameters for Burst therapy 131 Parameters for Ramp therapy 131 Parameters for Ramp+ therapy 132 Considerations 132 Restrictions 133 How to program ATP therapies 133 Details about ATP therapies 134

Treating VT and FVT with cardioversion 140

Parameters 140 Considerations 141 Restrictions 142 How to program cardioversion therapies 142 Details about cardioversion therapy 143

Optimizing therapy with Smart Mode and Progressive Episode Therapies 149

Parameters 149 Considerations 149 Restrictions 150 How to program Smart Mode 150 Details about Smart Mode 151 How to program Progressive Episode Therapies 152 Details about Progressive Episode Therapies 152

Key ter ms 153

vii

8 Treating bradycardia 157

Providing basic pacing therapy 158

Parameters 158 Considerations 159 Restrictions 160 How to program bradycardia pacing parameters 160 Details about basic bradycardia pacing 161

Enhancing pacing for optimal cardiac output 162

Parameters 162 Considerations 163 Restrictions 163 How to program Rate Response 164 Details about Rate Responsive Pacing 165 How to program Hysteresis 169 Details about Hysteresis 169

Marquis VR 7230Cx, B, and E Reference Manual

viii

Table of contents

How to program Ventricular Rate Stabilization 171 Details about Ventricular Rate Stabilization 171

Providing pacing after high voltage therapies 173

Parameters 173 Considerations 173 How to program pacing after high voltage therapies 174 Details about Post Shock Pacing parameters 174

Key ter ms 174

9 Optimizing charge time and device longevity 177

Optimizing charge time 178

Parameters 178 Considerations 178 How to evaluate charging performance 179 Details about managing charge time 179

Optimizing device longevity 181

Considerations 181

Key ter ms 182

Part IV Evaluating and managing patient treatment

10 Using the programmer 185

Connecting the programmer hardware 186

Using an external printer 187

To view a list of supported printers 188 Materials you will need 188 To connect the printer to your programmer 190

Using the programming head 192

During an episode in progress 192 During marker transmissions 192 How capacitor charging affects the light array 193 Alternative program and interrogate buttons 193

Display screen features 193

Programmer status bar display 194 Live Rhythm Monitor window 195 Task area 196 Command bar 198 Tool palette 198 Buttons 200

Marquis VR 7230Cx, B, and E Reference Manual

Setting programmer preferences 200

How to set the programmer time and date 201 How to set audio preferences 201 How to select a different language 202 How to check the software version number 203 How to set printing preferences 203 How to set reports preferences 204

Starting and ending patient sessions 204

How to start a patient session 205 How to end a patient session 206 Automatic interrogation 206

Viewing live waveforms 207

Parameters 207 How to use the Adjust window 208 How to use the waveform adjustment button bar 209 Details about the live rhythm monitor 209

Recording live waveforms 213

Printing a report while recording live ECG 214

Saving and retrieving device data 215

Considerations 215 How to save ICD data to a disk 216 How to read ICD data from a disk 216 Saving data to a disk 218 Data file names 218 Reading device data from diskette 218

Printing reports 219

How to print a report 220 Print Queue 220

Key ter ms 221

Table of contents

11 Using system evaluation tools 223

A summary of system evaluation tools 224

Automatic daily measurements 224

Taking a quick look at device activity 225

How to use Quick Look 225 Quick Look observations 226

Using the Patient Alert feature 227

Parameters 227 Considerations 229

Marquis VR 7230Cx, B, and E Reference Manual

Table of contents

How to program the Patient Alert feature 232 Instructing the patient 232 Viewing the Patient Alert Events 233 How to view the Patient Alert events 234

Streamlining follow-ups with Checklist 235

How to select and use a checklist 236 How to create, edit, and delete a checklist 237

Key ter ms 238

12 Setting up and viewing collected data 239

A summary of data collection 240

Setting up data collection 241

Parameters 241 Considerations 242 How to set up data collection 243 Details about data collection parameters 244 How to clear collected data 247

Collecting lead performance data 247

Daily lead impedance and EGM amplitude measurements 247 Sensing integrity counter 249

Viewing the episode and therapy efficacy counters 249

How to view and print counter data 250 Details about the episode and therapy efficacy counters 251 Therapy counters 253

Viewing episode data 254

How to view episode data 255 Details about episode data 256 How to view an Interval Plot 258 How to view an EGM Strip 259 How to display the episode text information 261 How to display QRS Snapshot data 262

Viewing Flashback Memory 263

How to view the Flashback Memory 264

Viewing battery and lead status data 265

How to view battery and lead status data 267

Viewing lead performance trends 267

How to view lead performance trend graphs 268

Using Cardiac Compass to view long term clinical trends 269

Marquis VR 7230Cx, B, and E Reference Manual

How to print a Cardiac Compass report 271 Details on Cardiac Compass trend data 271

Viewing and entering patient information 275

How to view and enter new patient information 277 Displaying and printing patient information 277

Automatic device status monitoring 278

Device status indicator warnings 278 How to respond to an electrical reset 279

Key ter ms 280

13 Testing the system 285

Testing overview 286

Evaluating the underlying rhythm 287

Considerations 287 How to Perform an Underlying Rhythm test 287

Measuring pacing thresholds 288

Parameters 289 Considerations 289 How to Perform a Pacing Threshold Test 290

Testing the Wavelet criterion 291

Parameters 291 Considerations 291 Restrictions 293 How to evaluate the current template with the Wavelet test 293 How to collect a template with the Wavelet test 294

Measuring lead impedance 295

Considerations 295 How to perform a Lead impedance test 295 Details about the Lead Impedance test 296

Measuring EGM Amplitude 297

Parameters 297 Considerations 297 Restrictions 298 How to perform an EGM Amplitude test 298

Testing the device capacitors 299

Considerations 299 How to perform a Charge/Dump test 300

Key ter ms 301

Table of contents

Marquis VR 7230Cx, B, and E Reference Manual

xii

Table of contents

14 Conducting Electrophysiologic Studies 303

EP Study overview 304

Inducing VF with T-Shock 306

Parameters 306 Considerations 307 Restrictions 307 How to deliver a T-Shock induction 308 Details about T-Shock induction 308

Inducing VF with 50 Hz Burst 309

Parameters 309 Considerations 310 How to deliver a 50 Hz Burst induction 311 Details about 50 Hz Burst induction 312

Inducing an arrhythmia with Manual Burst 312

Parameters 312 Considerations 312 How to deliver a Manual Burst induction 313 Details about Manual Burst induction 314

Inducing an arrhythmia with PES 314

Parameters 314 Considerations 315 How to deliver a PES induction 315 Details about PES induction 316

Delivering a manual therapy 316

Parameters for manual defibrillation and cardioversion 316 Parameters for manual ATP therapies 316 Considerations 318 How to deliver a manual therapy 318 Details about manual therapies 318

Key ter ms 319

15 Solving system problems 321

Overview 322

Solving sensing problems 323

Solving tachyarrhythmia detection problems 324

Solving tachyarrhythmia therapy problems 325

Solving bradycardia pacing problems 326

Responding to device status indicators 327

Marquis VR 7230Cx, B, and E Reference Manual

Key ter ms 328

Part V Appendices

A Warnings and precautions 333

General warnings 334

Storage and handling 334

Resterilization 335

Device implantation and ICD programming 335

Lead evaluation and lead connection 337

Follow-up testing 338

Explant and disposal 339

Medical therapy hazards 339

Home and occupational environments 341

BDevice Parameters343

Emergency settings 344

Detection parameters 345

Therapy parameters 347

Bradycardia pacing parameters 349

System maintenance parameters 350

Data collection parameters 352

System test and EP study parameters 353

Fixed parameters 356

Patient information parameters 357

Programmer symbols 358

Parameter Interactions Window 359

Parameter interlocks 360

Table of contents

xiii

Index 361

Marquis VR 7230Cx, B, and E Reference Manual

xiv

Table of contents

Marquis VR 7230Cx, B, and E Reference Manual

Introduction

Using this manual

Before implanting the ICD, it is strongly recommended that you:

■

Refer to the product literature packaged with the ICD for information about prescribing the ICD.

■

Thoroughly read this manual and the technical manuals for the leads used with the device.

■

Discuss the procedure and the ICD system with the patient and any other interested parties, and provide them with any patient information packaged with the ICD.

Contacting technical support

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products.

Introduction

In addition, Medtronic maintains a professional staff of consultants to provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical consultants with appropriate expertise.

For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate address or telephone number listed on the back cover.

Customer education

Medtronic invites physicians to attend an education seminar on the complete ICD system. The course includes indications for use, an overview of ICD system functions, implant procedures, and patient management.

Marquis VR 7230Cx, B, and E Reference Manual

xvi

Introduction

References

Notice

The primary reference for background information is Zacouto FI, Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B, ed. Cardiac Pacing Diagnostic and Therapeutic Tools. New York: Springer-Verlag; 1976: 212-218.

See these additional references for more background information:

■

Singer I, Ed. Implantable Cardioverter-Defibrillator. Armonk, NY: Futura Publishing Co. 1994.

■

Singer I, Barold SS, Camm AJ, Eds. Nonpharmacological Therapy of Arrhythmias for the 21st Century: The State of the Art. Armonk, NY: Futura Publishing Co. 1998.

■

Estes M, Manolis AS, Wang P, Eds. Implantable Cardioverter-Defibrillators. New York, NY: Marcel Dekker, Inc.

1994.

■

Kroll MW, Lehmann MH, Eds. Implantable Cardioverter-Defibrillator Therapy: The Engineering-Clinical Interface. Norwell, MA: Kluwer Academic Publishers 1996.

This software is provided as an informational tool for the end user. The user is responsible for accurate input of patient information into the software. Medtronic makes no representation as to the accuracy or completeness of the data input into the software. MEDTRONIC SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTIAL OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULTS FROM THE USE OF THE INFORMATION PROVIDED IN THE SOFTWARE.

Marquis VR 7230Cx, B, and E Reference Manual

Abbreviations and acronyms

ATP Antitachycardia Pacing

BOL Beginning of Life

bpm beats per minute

CNID Combined (VT and VF) Number of Intervals to Detect

CV Cardioversion

DF/Defib Defibrillation

ECG Electrocardiogram

EGM Electrogram

EOL End of Life

ERI Elective Replacement Indicator

FDI Fibrillation Detection Interval

FTI Fast Ventricular Tachycardia Detection Interval

Abbreviations and acronyms

xvii

FVT Fast Ventricular Tachycardia

ICD Implantable Cardioverter Defibrillator

J joules

-1

reciprocal minutes; for example, pacing pulses per minute

min

ms milliseconds

mV millivolts

NID Number of Intervals to Detect

NST Non-sustained Tachycardia

PES Programmed Electrical Stimulation

ppm paces or pulses per minute

PVC Premature Ventricular Contraction

RNID Number of Intervals to Redetect

R-R a ventricular interval

SVT Supraventricular Tachycardia

Marquis VR 7230Cx, B, and E Reference Manual

xviii

Abbreviations and acronyms

TDI Tachycardia Detection Interval

V volts

V- Ventricular

VF Ventricular Fibrillation

VF NID VF Number of Intervals to Detect

VRS Ventricular Rate Stabilization

VT Ventricular Tachycardia

VT NID VT Number of Intervals to Detect

Marquis VR 7230Cx, B, and E Reference Manual

Quick overview

Part I

Marquis VR 7230Cx, B, and E Reference Manual

Physical characteristics 4

Magnet application 8

Longevity projections 9

Replacement indicators 12

Typical charge times 13

High voltage therapy energy 13

Stored data and diagnostics 14

New and enhanced features 17

Quick reference1

Marquis VR 7230Cx, B, and E Reference Manual

Chapter 1

Physical characteristics

Table 1-1. ICD physical characteristics

Connector type Cx

B or E

Volume 36 cc 43 cc

Mass 75 g 80 g

H x W x D

Surface area of device can 66 cm

Radiopaque ID

68 mm x 51 mm x 14 mm

74 mm x 51 mm x 14 mm

63 cm

PKD B-type connector PLW

E-type connector PLY

Materials in contact with human tissue

Titanium / polyurethane / silicone rubber

Battery Lithium silver vanadium oxide

Measurements are nominal values based on CAD (computer aided design) model measurements and are rounded to the nearest unit.

Grommets may protrude slightly beyond the can surface.

Engineering series number follows the radiopaque code.

These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue.

Marquis VR 7230Cx, B, and E Reference Manual

Table 1-2. Cx-type connector characteristics

General description

One IS-1 connector for pacing and sensing, Two DF-1 connectors for high voltage therapy, Active Can electrode (programmable).

Figure 1-1. Cx-type connector

Device Port

SVC DF-1 HVX

RV DF-1 HVB

Can n/a HVA, Can

V IS-1 bipolar

Quick reference

Physical characteristics

Connector Typ e

Software Name

1 suture holes

2 SVC port (DF-1)

3RV port (DF-1)

4 programmable Active Can

5V. port (IS-1)

Marquis VR 7230Cx, B, and E Reference Manual

Chapter 1

Physical characteristics

Table 1-3. B-type connector characteristics

General description

Port Connector Type

HVB 6.5 mm HVB

Device

Three 6.5 mm unipolar high voltage ports and one

3.2 mm low profile bipolar pace/sense (IS-1 compatible) port.

The HVA and HVX ports are electronically connected and are treated as the HVX electrode. For more information see “B- and E-type connector pathways” on page 123.

HVA

HVX

6.5 mm HVX

Can n/a HVA, Can

P/S bipolar pace sense

3.2 mm bipolar (IS-1 compatible)

Figure 1-2. B-type connector

Software Name

1 suture holes

2 HVB port (6.5 mm)

3 HVA port (6.5 mm)

4 programmable Active Can

5 HVX port (6.5 mm)

6/7 P+/S and P-/S port (3.2 mm)

Marquis VR 7230Cx, B, and E Reference Manual

Quick reference

Physical characteristics

Table 1-4. E-type connector characteristics

General description

Port

P+/S port 5.0 mm

Device

Two 6.5 mm unipolar high voltage ports and two 5 mm unipolar pace/sense ports.

HVA port 6.5 mm HVX

HVB port 6.5 mm HVB

Can n/a HVA, Can

P-/S port 5.0 mm

The HVA port of the E-type connector can be used as the HVX electrode when Active Can is programmed off, see “B- and E-type connector pathways” on page 123.

Figure 1-3. E-type connector

Connector Typ e

Software Name

1 suture holes

2 P+/S port (5.0 mm)

3 HVA port (6.5 mm)

4 programmable Active Can

5 HVB port (6.5 mm)

6 P-/S port (5.0 mm)

Marquis VR 7230Cx, B, and E Reference Manual

Chapter 1

Magnet application

Bringing a magnet close to the device triggers changes in device operation as shown in Table 1-5. When the magnet is removed, the device returns to its programmed operations.

Table 1-5. Effects of magnet application on the device

Pacing mode as programmed

Pacing rate and interval as programmed

VF, VT, and FVT detection suspended

Patient Alert audible tones (20 seconds or less)

with programmable alert(s) enabled:

■

continuous tone (Test)

■

on/off intermittent tone (seek follow-up)

■

high/low dual tone (urgent follow-up)

with programmable alerts disabled:

■

no tone

■

high/low dual tone (urgent follow-up)

Rate response adjustments are suspended while a Patient Alert tone sounds.

Detection resumes if telemetry is established and the application software is running, or it resumes after the application software has started.

The Test tone does not sound if “VF Detection/Therapy Off” is the only alert enabled.

Marquis VR 7230Cx, B, and E Reference Manual

Longevity projections

Longevity estimates are based on accelerated battery discharge data and device modeling with EGM pre-storage off, 60 ppm

-1

(min

) pacing rate, with

■

2.5 V pacing pulse amplitude, 0.4 ms pacing pulse width, and 30 J delivered therapy energy (see Table 1-6)

■

3 V pacing pulse amplitude, 0.4 ms pacing pulse width, and 30 J delivered therapy energy (see Table 1-7)

This model assumes default automatic capacitor formation setting. As a guideline, each full energy charge decreases device longevity by approximately 33 days.

Device longevity is affected by how certain features are programmed, such as EGM pre-storage. For more information, see “Optimizing device longevity” on page 181.

Considerations for using EGM pre-storage

When the EGM pre-storage feature is programmed off, the device starts to store EGM following the third tachyarrhythmia event and also provides up to 20 seconds of information before the onset of the tachyarrhythmia, including:

■

VV intervals

■

Marker Channel

■

interval plot Flashback

Quick reference

Longevity projections

When the EGM pre-storage feature is programmed on, the device also collects up to 20 seconds of EGM information before the onset of the arrhythmia.

In a patient who uniformly repeats the same onset mechanisms, the greatest clinical benefit of pre-onset EGM storage is achieved after a few episodes are captured.To maximize the effectiveness of the EGM pre-storage feature and optimize device longevity, consider these programming options:

■

Turn pre-storage on to capture possible changes in the onset mechanism following significant clinical adjustments, for example, device implant, medication changes, and surgical procedures.

■

Turn pre-storage off once you have successfully captured the information of interest.

Marquis VR 7230Cx, B, and E Reference Manual

Chapter 1

Longevity projections

Table 1-6. Projected longevity in years with 2.5 V pacing amplitude and

0.4 ms pulse width

Percent pacing

Maximum energy charging frequency

EGM pre-storage

500 ohm

impedance

pacing

900 ohm

pacing

impedance

0% Semi-Annual Off 10.4 10.4

On 10.0 10.0

Quarterly Off 8.7 8.7

On 8.5 8.5

15% Semi-Annual Off 10.0 10.2

On 9.9 10.0

Quarterly Off 8.5 8.6

On 8.3 8.4

50% Semi-Annual Off 9.5 10.0

On 9.3 9.7

Quarterly Off 8.1 8.4

On 8.0 8.2

100% Semi-Annual Off 8.9 9.5

On 8.6 9.3

Quarterly Off 7.6 8.1

On 7.5 8.0

Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.

The data provided for programming EGM pre-storage on is based on a 6 month period (two 3-month follow-up intervals) over the life of the device. Additional use of EGM pre-storage reduces longevity by approximately 25% or 3 months per year.

Marquis VR 7230Cx, B, and E Reference Manual

+ 370 hidden pages

Medtronic 7230B Reference Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction

Using this manual

Contacting technical support

Customer education

References

Notice

Abbreviations and acronyms

Quick overview

Quick reference1

Physical characteristics

Magnet application

Longevity projections