Medtronic D314VRG Clinician Manual

Protecta™ XT VR D314VRG

Digital single chamber implantable cardioverter defibrillator (VVE-VVIR)

SmartShock® Technology (RV Lead Noise Discrimination, RV Lead Integrity Alert, TWave
Discrimination, Confirmation+, Wavelet), OptiVol® 2.0 Fluid Status Monitoring, Complete Capture
Management® Diagnostic (RVCM) and ATP During Charging™ Feature

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

Protecta™ XT VR D314VRG

Clinician Manual

A guide to the operation and programming of the Model D314VRG Protecta XT VR digital single
chamber implantable cardioverter defibrillator (VVE-VVIR)

The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their respective
owners.

Active Can, ATP During Charging, Capture Management, Cardiac Compass, CardioSight,
CareAlert, CareLink, ChargeSaver, Conexus, EnTrust, Export, Flashback, GEM, GEM DR,
InSync, InSync III Marquis, InSync Marquis, Integrity, Intrinsic, Kappa, Marker Channel,
Marquis, Medtronic, Medtronic CareAlert, Medtronic CareLink, OptiVol, Paceart, Protecta,
Quick Look, SessionSync, SmartShock, SureScan, Switchback, T-Shock, TherapyGuide

Medtronic

Protecta™ XT VR D314VRG

Contents

1 System overview ....................................................... 9

1.1 Introduction ....................................................... 9

1.2 System description ................................................ 18

1.3 Indications and usage ............................................. 21

1.4 Contraindications ................................................. 21

2 Warnings, precautions, and potential adverse events .................... 22

2.1 General warnings and precautions .................................. 22

2.2 Explant and disposal .............................................. 22

2.3 Handling and storage instructions ................................... 23

2.4 Lead evaluation and lead connection ................................ 23

2.5 Device operation ................................................. 24

2.6 Warnings, precautions, and guidance for clinicians performing medical

procedures on cardiac device patients ............................... 26

2.7 Warnings, precautions, and guidance related to electromagnetic interference

(EMI) for cardiac device patients .................................... 32

2.8 Potential adverse events ........................................... 36

3 Clinical data .......................................................... 39

3.1 Adverse events and clinical trial data ................................ 39

4 Using the programmer ................................................. 41

4.1 Establishing telemetry between the device and the programmer ......... 41

4.2 Conducting a patient session ....................................... 48

4.3 Display screen features ............................................ 53

4.4 Delivering an emergency tachyarrhythmia therapy ..................... 58

4.5 Enabling emergency VVI pacing .................................... 59

4.6 Streamlining implant and follow-up sessions with Checklist ............. 61

4.7 Viewing and programming device parameters ......................... 66

4.8 Saving and retrieving a set of parameter values ....................... 71

4.9 Using TherapyGuide to select parameter values ....................... 72

4.10 Viewing and entering patient information ............................. 76

4.11 Working with the Live Rhythm Monitor ............................... 80

4.12 Expediting follow-up sessions with Leadless ECG ..................... 87

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4.13 Saving and retrieving device data ................................... 88

4.14 Using SessionSync to transfer device data to the Paceart system ........ 90

4.15 Printing reports ................................................... 97

5 Implanting the device ................................................. 104

5.1 Preparing for an implant .......................................... 104

5.2 Selecting and implanting the leads ................................. 106

5.3 Testing the lead system ........................................... 108

5.4 Connecting the leads to the device ................................. 109

5.5 Performing ventricular defibrillation threshold tests .................... 112

5.6 Positioning and securing the device ................................ 115

5.7 Completing the implant procedure .................................. 116

5.8 Replacing a device ............................................... 117

6 Conducting a patient follow-up session ................................ 119

6.1 Patient follow-up guidelines ....................................... 119

6.2 Viewing a summary of recently stored data .......................... 123

6.3 Automatic alerts and notification of clinical management and system

performance events .............................................. 126

6.4 Monitoring leads using RV Lead Integrity Alert ....................... 135

6.5 Viewing long-term clinical trends with the Cardiac Compass Report ..... 143

6.6 Viewing heart failure management information ....................... 148

6.7 Monitoring for thoracic fluid accumulation with OptiVol ................ 154

6.8 Viewing Arrhythmia Episodes data and setting data collection

preferences ..................................................... 160

6.9 Viewing episode and therapy counters .............................. 169

6.10 Viewing Flashback Memory data ................................... 172

6.11 Using rate histograms to assess heart rates ......................... 173

6.12 Viewing detailed device and lead performance data .................. 175

6.13 Automatic device status monitoring ................................. 182

6.14 Optimizing device longevity ....................................... 185

7 Configuring pacing therapies ......................................... 188

7.1 Sensing intrinsic cardiac activity ................................... 188

7.2 Providing pacing therapies ........................................ 194

7.3 Providing rate-responsive pacing ................................... 197

7.4 Managing pacing output energies with Capture Management .......... 204

7.5 Promoting the intrinsic rate during periods of inactivity ................ 213

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7.6 Providing a slower pacing rate during periods of sleep ................ 215

7.7 Increasing the pacing output after a high-voltage therapy .............. 217

7.8 Smoothing the ventricular rate during conducted AF .................. 217

7.9 Providing overdrive pacing after a VT/VF high-voltage therapy .......... 219

7.10 Responding to PVCs using Ventricular Rate Stabilization .............. 220

8 Configuring tachyarrhythmia detection ................................ 224

8.1 Detecting ventricular tachyarrhythmias .............................. 224

8.2 Discriminating VT/VF from SVT using Wavelet ....................... 241

8.3 Discriminating sinus tachycardia from VT using the Onset feature ....... 249

8.4 Discriminating AT/AF from VT using the Stability feature ............... 255

8.5 Detecting prolonged tachyarrhythmias using High Rate Timeout ........ 258

8.6 Discriminating RV lead noise from VT/VF ............................ 260

8.7 Discriminating T-wave oversensing from VT/VF ...................... 266

8.8 Suspending and resuming tachyarrhythmia detection ................. 270

9 Configuring tachyarrhythmia therapies ................................ 272

9.1 Treating episodes detected as VF .................................. 272

9.2 Treating VT and FVT episodes with antitachycardia pacing therapies .... 284

9.3 Treating VT and FVT with ventricular cardioversion ................... 295

9.4 Optimizing therapy with Progressive Episode Therapies ............... 303

9.5 Optimizing charge time with Automatic Capacitor Formation ........... 306

10 Testing the system ................................................... 310

10.1 Evaluating the underlying rhythm ................................... 310

10.2 Measuring pacing thresholds ...................................... 310

10.3 Testing the Wavelet feature ........................................ 312

10.4 Measuring lead impedance ........................................ 317

10.5 Performing a Sensing Test ........................................ 317

10.6 Testing the device capacitors ...................................... 319

10.7 Inducing an arrhythmia ........................................... 321

10.8 Delivering a manual therapy ....................................... 327

A Quick reference ....................................................... 330

A.1 Physical characteristics ............................................ 330

A.2 Replacement indicators ............................................ 331

A.3 Projected service life .............................................. 331

A.4 Energy levels and typical charge times ............................... 333

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A.5 Magnet application ................................................ 334

A.6 Stored data and diagnostics ........................................ 334

B Device parameters .................................................... 340

B.1 Emergency settings ............................................... 340

B.2 Tachyarrhythmia detection parameters ............................... 341

B.3 Ventricular tachyarrhythmia therapy parameters ....................... 342

B.4 Pacing parameters ................................................ 345

B.5 Medtronic CareAlert parameters .................................... 348

B.6 Data collection parameters ......................................... 350

B.7 System test parameters ............................................ 351

B.8 EP study parameters .............................................. 352

B.9 Nonprogrammable parameters ..................................... 354

Glossary ................................................................ 356

Index ................................................................... 361

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Protecta™ XT VR D314VRG

1 System overview

1.1 Introduction

1.1.1 About this manual

This manual describes the operation and intended use of the Protecta XT VR Model
D314VRG system.

1.1.1.1 Manual conventions

Throughout this manual, the word “device” refers to the implanted Protecta XT VR device.

The symbol in parameter tables indicates the Medtronic nominal value for that parameter.

The programmer screen image examples in this manual were produced using a Medtronic
CareLink Model 2090 Programmer. These screen images are provided for reference only
and may not match the final software.

The names of on-screen buttons are shown within brackets: [Button Name].

Programming instructions in this manual are often represented by a programming block,
which describes the path through the application software to specific screens or parameters.
The following conventions are used in programming blocks:

• The “⇒” symbol precedes the screen text you can select to navigate to a new screen.

• The “▷” symbol precedes the name of a parameter you can program for a feature.

• When a navigation step refers to a field on the screen that is labeled with both a row title
and a column title, the “ | ” character is used to divide the separate titles. Parameter
values, however, do not use this convention.

• When a particular value for a parameter must be selected to make the remaining
parameters or navigation possible, that value appears within <brackets>.

Here is an example of a programming block using these conventions:

Select Params icon

⇒ Screen text to select…

⇒ Screen field Row Title | Column Title…

▷ Parameter Name <Required Value>
▷ Parameter Name
▷ Parameter Name

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Protecta™ XT VR D314VRG

1.1.2 Product literature

Before implanting the device, it is strongly recommended that you take the following actions:

• Read the product literature provided for information about prescribing, implanting, and
using the device, and for conducting a patient follow-up session.

• Thoroughly read the technical manuals for the leads used with the device. Also read the
technical manuals for other system components.

• Discuss the device and implant procedure with the patient and any other interested
parties, and provide them with any patient information materials packaged with the
device.

1.1.3 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.

In addition, Medtronic maintains a professional staff of consultants to provide technical
consultation to product users.

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.

1.1.4 Customer education

Medtronic invites physicians to attend an educational seminar on the device. The course
describes indications for use, system functions, implant procedures, and patient
management.

1.1.5 Explanation of symbols

The following list of symbols and abbreviations applies to various products. Refer to the
package labels to see which of these apply to this product.

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Table 1. Explanation of symbols on package labeling

Symbol Explanation

Conformité Européenne (European Conformity). This symbol means that
the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and
R&TTE Directive 1999/5/EC.

This symbol means that the device fully complies with the Australian
Communications and Media Authority (ACMA) and the New Zealand Min­istry of Economic Development Radio Spectrum Management standards
for radio communications products.

Radio compliance. This symbol means that telecommunications and radio
communications regulations in your country may apply to this product.
Please go to www.medtronic.com/radio for specific compliance informa­tion related to telecommunications and radio standards for this product in
your country.

MR Conditional. The SureScan pacing system is safe for use in the MRI
environment when used according to the instructions in the SureScan
technical manual.
Note: Not all devices are MR Conditional.

Caution

Open here

Do not use if package is damaged

Do not reuse

Sterilized using ethylene oxide

Consult instructions for use

For US audiences only

Date of manufacture

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EC REP

Medtronic Protecta™ XT VR D314VRG

Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

Manufacturer

Authorized representative in the European community

Use by

Lot number

Reorder number

Serial number

Temperature limitation

Adaptive

Package contents

Implantable device

IPG device

Coated (IPG device)

ICD device

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Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

Coated (ICD device)

Cardiac resynchronization therapy (CRT) device

Coated (CRT device)

Dual chamber IPG with cardiac resynchronization therapy (CRT-P)

Product documentation

Torque wrench

Accessories

Amplitude/pulse width

Atrial amplitude/pulse width

RV amplitude/pulse width

LV amplitude/pulse width

Upper tracking rate/lower rate

Rate

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Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

Lower rate

Sensitivity

Sensed A-V interval

A-V interval (paced/sensed)

Refractory period

Atrial refractory period

Ventricular refractory period

(PVARP) Post Ventricular Atrial Refractory Period

Polarity

Pacing polarity (single chamber)

Pacing polarity (dual chamber)

LV Pace polarity

Atrial Pace polarity

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Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

RV Pace polarity

Sensing polarity (single chamber)

Sensing polarity (dual chamber)

Atrial sensitivity

Ventricular sensitivity

VF therapies (delivered/stored)

VT therapies

V pacing/V-V pace delay

VT monitor

AT/AF detection

VT, VF detection

VT, FVT, VF detection

AT/AF therapies

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Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

VT, VF therapies

VT, FVT therapies (CRT)

AT/AF intervention

Burst

Burst (CRT)

Burst+

50 Hz Burst

A ramp

Ramp (CRT)

Ramp+

Ramp+ (CRT)

V ramp

AV ramp

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Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

Defibrillation

V cardioversion

AV cardioversion

FVT therapies

Mode Switch

Magnet Rate

Dangerous voltage

Active Can

TR Triple chamber rate responsive pacemaker

DR Dual chamber rate responsive pacemaker

D Dual chamber pacemaker

SR Single chamber rate responsive pacemaker

S Single chamber pacemaker

1.1.6 Notice

The Patient Information screen of the programmer software application 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 patient information that end users enter into the Patient Information
screen. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULT FROM THE
USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE SOFTWARE.

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For more information about the Patient Information screen, see Section 4.10.

Protecta™ XT VR D314VRG

1.2 System description

The Medtronic Model D314VRG Protecta XT VR single chamber implantable cardioverter
defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the
patient’s heart rate by providing single chamber rate-responsive bradycardia pacing and
ventricular tachyarrhythmia therapies.

The device senses the electrical activity of the patient’s heart using the electrodes of the
implanted right ventricular lead. It then analyzes the heart rhythm based on selectable
detection parameters.

The device can automatically detect ventricular tachyarrhythmias (VT/VF) and provides
treatment with defibrillation, cardioversion, or antitachycardia pacing therapies. The device
responds to bradyarrhythmias by providing bradycardia pacing therapy.

The device also provides diagnostic and monitoring information that assists with system
evaluation and patient care.

Leads – The lead system used with this device must provide sensing, pacing and
cardioversion/defibrillation therapies to the right ventricle (RV). Do not use any lead with this
device without first verifying lead and connector compatibility.

For information about selecting and implanting leads for this device, refer to Section 5.2,
Selecting and implanting the leads, page 106.

Implantable device system – The Model D314VRG Protecta XT VR along with its pacing
lead and defibrillation leads constitute the implantable portion of the device system. The
following figure shows the major components that communicate with the implantable device
system.

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VVI

Medtronic CareLink Programmer and

Analyzer

Conexus Activator

Medtronic CareLink Monitor

Implantable device

system

InCheck Patient

Assistant

AF?

Clinic

Home

Medtronic

Figure 1. System components

Protecta™ XT VR D314VRG

Programmers and software – The Medtronic CareLink Model 2090 Programmer and
software are used to program this device. The Medtronic CareLink Model 2090 Programmer
with Conexus wireless telemetry is designed to provide clinicians and patients with an easy
and efficient implant, follow-up, and monitoring experience. Conexus wireless telemetry
eliminates the need to have a programming head placed over the implanted device for the
duration of a programming or monitoring session. The system uses radio frequency (RF)
telemetry for wireless communication between the implanted device and programmer in the
hospital or clinic. Conexus telemetry operates within the Medical Implant Communications
Service (MICS) Band, which is the only band designated for implantable medical devices.
Using the MICS Band prevents interference with home electronics such as microwaves, cell
phones, and baby monitors.

To turn on Conexus telemetry in an implanted device, you must use the Conexus Activator or
the programming head. If you do not use the Conexus Activator or if you are using a
programmer with nonwireless telemetry, you will need to use the programming head to both
initiate and conduct communications with the device in the clinic.

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During a wireless telemetry session, all other programmers are prevented from
communicating or initiating a session with the patient’s implanted device, maintaining
patient safety and privacy. Similarly, other patients with implanted devices are not affected by
any communication or programming occurring during the patient’s session.

Programmers from other manufacturers are not compatible with Medtronic devices but will
not damage Medtronic devices.

Model 27901 Conexus Activator – The Medtronic Model 27901 Conexus Activator allows
you to turn on Conexus wireless telemetry for implanted devices that support wireless
telemetry. The Conexus Activator is used in conjunction with the Medtronic CareLink Model
2090 Programmer with Conexus telemetry in the hospital or clinic.

Model 2290 Analyzer – The system supports the use of the Medtronic CareLink Model
2290 Analyzer, an accessory of the Medtronic CareLink programmer. The system allows you
to have a device session and an analyzer session running at the same time, to quickly switch
from one to the other without having to end or restart sessions, and to send data from the
analyzer to the programmer.

Model 2490C Medtronic CareLink Monitor – Patients use the Model 2490C monitor to
automatically gather information from their implanted device and communicate the
information to their physician. The monitor communicates wirelessly with the patient’s
device and transmits the information over a home telephone line at times scheduled by the
clinic. Typically, these transmissions are scheduled while the patient is asleep. The monitor
can also send Medtronic CareAlert Notifications to the clinic outside of the scheduled
transmission times, if the device has been programmed to do so. The patient does not need
to interact with the monitor other than performing the initial setup procedure. Refer to the
monitor literature for connection and usage information.

Model 2696 InCheck Patient Assistant – Patients can use the Model 2696 InCheck
Patient Assistant to initiate recording of cardiac event data in the device memory. Cardiac
event data can be viewed either on the programmer or using CareLink. In addition, when the
InCheck Patient Assistant is activated, the EGM signals of the programmed EGM sources
and markers are stored in the device and are available for review using CareLink. The
CareLink Monitor transmits the EGM data and markers from the patient’s device to the
CareLink Network. You can identify patients who have new, not previously viewed
patient-activated episodes and then proceed to view their EGM data using the Detailed EGM
Viewer on CareLink.

Contents of sterile package – The package contains one implantable cardioverter
defibrillator, one torque wrench, and one DF-1 pin plug.

Protecta™ XT VR D314VRG

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Protecta™ XT VR D314VRG

1.3 Indications and usage

The Protecta XT VR system is indicated to provide ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

1.4 Contraindications

The Protecta XT VR system is contraindicated for patients experiencing tachyarrhythmias
with transient or reversible causes including, but not limited to, the following: acute
myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance,
hypoxia, or sepsis.

The device is contraindicated for patients who have a unipolar pacemaker implanted.

The device is contraindicated for patients with incessant VT or VF.

The device is contraindicated for patients whose primary disorder is atrial tachyarrhythmia.

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Protecta™ XT VR D314VRG

2 Warnings, precautions, and potential adverse events

2.1 General warnings and precautions

Avoiding shock during handling – Disable tachyarrhythmia detection during implant,

explant, or postmortem procedures. The device can deliver a high-voltage shock if the
defibrillation terminals are touched.

Electrical isolation during implant – Do not allow the patient to have contact with
grounded electrical equipment that might produce electrical current leakage during implant.
Electrical current leakage may induce tachyarrhythmias that may result in the patient’s
death.

External defibrillation equipment – Keep external defibrillation equipment nearby for
immediate use whenever tachyarrhythmias are possible or intentionally induced during
device testing, implant procedures, or post-implant testing.

Lead compatibility – Do not use another manufacturer’s leads without demonstrated
compatibility with Medtronic devices. If a lead is not compatible with a Medtronic device, the
result may be undersensing of cardiac activity, failure to deliver necessary therapy, or a
leaking or intermittent electrical connection.

2.2 Explant and disposal

Consider the following information related to device explant and disposal:

• To prevent the device from delivering unwanted shocks, interrogate the device and
disable tachyarrhythmia detection before explanting, cleaning, or shipping the device.

• Explant the implanted device postmortem. In some countries, explanting
battery-operated implanted devices is mandatory because of environmental concerns;
check the local regulations. In addition, the device may explode if subjected to
incineration or cremation temperatures.

• Medtronic implantable devices are intended for single use only. Do not resterilize and
reimplant explanted devices.

• Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and
disposal. See the back cover for addresses.

Note: Disposal of explanted devices or leads is subject to local, state, and federal
regulations.

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Protecta™ XT VR D314VRG

2.3 Handling and storage instructions

Carefully observe these guidelines when handling or storing the device.

2.3.1 Device handling

Checking and opening the package – Before opening the sterile package tray, visually

check for any signs of damage that might invalidate the sterility of the package contents.

If the package is damaged – The device packaging consists of an outer tray and inner tray.
Do not use the device or accessories if the outer packaging tray is wet, punctured, opened,
or damaged. Return the device to Medtronic because the integrity of the sterile packaging or
the device functionality may be compromised. This device is not intended to be resterilized.

Sterilization – Medtronic has sterilized the package contents with ethylene oxide before
shipment. This device is for single use only and is not intended to be resterilized.

Device temperature – Allow the device to reach room temperature before it is programmed
or implanted. Device temperature above or below room temperature may affect initial device
function.

Dropped device – Do not implant the device if it has been dropped on a hard surface from
a height of 30 cm (12 in) or more after it is removed from its packaging.

“Use by” date – Do not implant the device after the “Use by” date because the battery
longevity could be reduced.

For single use only – Do not resterilize and reimplant an explanted device.

2.3.2 Device storage

Avoid magnets – To avoid damaging the device, store the device in a clean area away from

magnets, kits containing magnets, and any sources of electromagnetic interference.

Temperature limits – Store and transport the package between –18°C and +55°C (0°F and
131°F). Electrical reset may occur at temperatures below –18°C (0°F). Device longevity may
decrease and performance may be affected at temperatures above +55°C (131°F).

2.4 Lead evaluation and lead connection

Refer to the lead technical manuals for specific instructions and precautions about lead
handling.

Hex wrench – Use only the torque wrench supplied with the device. The torque wrench is
designed to prevent damage to the device from overtightening a setscrew. Other torque

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wrenches, (for example a blue-handled or right-angled hex wrench) have torque capabilities
greater than the lead connector can tolerate.

Lead connection – Consider the following information when connecting the lead and the
device:

• Cap abandoned leads to avoid transmitting electrical signals.

• Plug any unused lead ports to protect the device.

• Verify lead connections. Loose lead connections may result in inappropriate sensing
and failure to deliver arrhythmia therapy.

Lead Impedance – Consider the following information about lead impedance when
evaluating the lead system:

• Ensure that the defibrillation lead impedance is greater than 20 Ω. An impedance of less
than 20 Ω may damage the device or prevent delivery of high-voltage therapy.

• Before taking electrical or defibrillation efficacy measurements, move objects made
from conductive materials, such as guide wires, away from all electrodes. Metal objects,
such as guide wires, can short circuit a device and lead, causing electrical current to
bypass the heart and possibly damage the device and lead.

Patch leads – Do not fold, alter, or remove any portion of a patch lead. Doing so may
compromise electrode function or longevity.

Protecta™ XT VR D314VRG

2.5 Device operation

Accessories – Use this device only with accessories, parts subject to wear, and disposable

items that have been tested to technical standards and found safe by an approved testing
agency.

Battery depletion – Carefully monitor battery longevity by checking battery voltage and
replacement indicators. Battery depletion eventually causes the device to stop functioning.
Cardioversion and defibrillation are high-energy therapies that shorten battery longevity. An
excessive number of charging cycles also shortens battery longevity.

Charge Circuit Timeout or Charge Circuit Inactive – Contact a Medtronic representative
and replace the device immediately if the programmer displays a Charge Circuit Timeout or
Charge Circuit Inactive message. If this message is displayed, high-voltage therapies are
not available for the patient.

Concurrent pacemaker use – If a separate pacemaker is used concurrently with the ICD,
verify that the ICD does not sense the pacemaker output pulses because this can affect the
detection of tachyarrhythmias by the ICD. Program the pacemaker to deliver pacing pulses
at intervals longer than the ICD tachyarrhythmia detection intervals.

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Device status indicators – If any of the device status indicators (for example, Electrical
Reset) are displayed on the programmer after interrogating the device, inform a Medtronic
representative immediately. If these device status indicators are displayed, therapies may
not be available to the patient.

Electrical reset – Electrical reset can be caused by exposure to temperatures below –18°C
(0°F) or strong electromagnetic fields. Advise patients to avoid strong electromagnetic
fields. Observe temperature storage limits to avoid exposure of the device to cold
temperatures. If a partial reset occurs, pacing resumes in the programmed mode with many
of the programmed settings retained. If a full reset occurs, the device operates in VVI mode
at 65 bpm. Electrical reset is indicated by a programmer warning message that is displayed
immediately upon interrogation. To restore the device to its previous operation, it must be
reprogrammed. Inform a Medtronic representative if your patient’s device has reset.

End of Service (EOS) indicator – Replace the device immediately if the programmer
displays an EOS indicator. The device may soon lose the ability to pace, sense, and deliver
therapy adequately.

Follow-up testing – Consider the following information when performing follow-up testing
of the device:

• Keep external defibrillation equipment nearby for immediate use. Potentially harmful
spontaneous or induced tachyarrhythmias may occur during device testing.

• Changes in the patient’s condition, drug regimen, and other factors may change the
defibrillation threshold (DFT), preventing the device from terminating the patient’s
tachyarrhythmias postoperatively. Successful termination of ventricular fibrillation or
ventricular tachycardia during the implant procedure is no assurance that
tachyarrhythmias can be terminated postoperatively.

Higher than programmed energy – The device may deliver a therapy of higher than
programmed energy if it was previously charged to a higher energy and that charge remains
on the capacitors.

Magnets – Positioning a magnet over the device suspends tachyarrhythmia detection but
does not alter bradycardia therapy. If you place a programming head over the device during
a wireless telemetry session, the magnet in the programming head always suspends
tachyarrhythmia detection. If you place a programming head over the device and establish
a nonwireless telemetry session, tachyarrhythmia detection is not suspended.

Pacing and sensing safety margins – Lead maturation (at least one month after implant)
may cause sensing amplitudes to decrease and pacing thresholds to increase, which can
cause undersensing or a loss of capture. Provide an adequate safety margin when selecting
values for pacing amplitude, pacing pulse width, and sensitivity parameters.

Patient safety during a wireless telemetry session – Make sure that you have selected
the appropriate patient before proceeding with a wireless patient session. Maintain visual

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contact with the patient for the duration of the session. If you select the wrong patient and
continue with the session, you may inadvertently program the patient’s device to the wrong
settings.

Programmers – Use only Medtronic programmers and application software to
communicate with the device. Programmers and software from other manufacturers are not
compatible with Medtronic devices.

Rate-responsive modes – Do not program rate-responsive modes for patients who cannot
tolerate rates above the programmed Lower Rate. Rate-responsive modes may cause
discomfort for those patients.

RV Capture Management – RV Capture Management does not program right ventricular
outputs to values greater than 5.0 V or 1.0 ms. If the patient needs right ventricular pacing
output greater than 5.0 V or 1.0 ms, manually program right ventricular amplitude and pulse
width. If a lead dislodges partially or completely, RV Capture Management may not prevent
loss of capture.

Shipping values – Do not use shipping values or nominal values for pacing amplitude and
sensitivity without verifying that the values provide adequate safety margins for the patient.

Twiddler’s syndrome – Twiddler’s syndrome, the tendency of some patients to manipulate
their device after implant, may cause the pacing rate to increase temporarily if the device is
programmed to a rate-responsive mode.

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2.5.1 Pacemaker-dependent patients

OVO pacing mode – Pacing is disabled under OVO mode. Do not program the OVO mode

for pacemaker-dependent patients. Instead, use the Underlying Rhythm test to provide a
brief period without pacing support.

Underlying Rhythm Test – Use caution when using the Underlying Rhythm Test to inhibit
pacing. The patient is without pacing support when pacing is inhibited.

2.6 Warnings, precautions, and guidance for clinicians performing medical procedures on cardiac device patients

This section is intended for physicians and other health care professionals who perform
medical procedures on patients with Medtronic implanted cardiac device systems and who
consult with the patients’ cardiologists. This section provides warnings, precautions, and
guidance related to medical therapies and diagnostic procedures that may cause serious
injury to a patient, interfere with a Medtronic implanted cardiac device system, or
permanently damage the system.

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Note: Some common medical procedures that pose no risk are also listed in this section.

For additional guidance on medical procedures not addressed in this section, customers
can contact the following resources:

• Customers in the United States can contact either of the following telephone numbers:
for pacemakers, contact Medtronic Technical Services at [phone]; for ICDs,
contact Medtronic Technical Services at [phone]. You may also submit
questions to [e-mail] or your Medtronic representative.

• Customers outside of the United States can contact a Medtronic representative.

Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which
radio frequency (RF) or microwave energy is used to destroy cells by creating heat. Ablation
used in cardiac device patients may result in, but is not limited to, induced ventricular
tachyarrhythmias, oversensing, unintended tissue damage, device damage, or device
malfunction.

Pulse-modulated ablation systems may pose higher risk for induced ventricular
tachyarrhythmias. Medtronic cardiac devices are designed to withstand exposure to
ablation energy. To mitigate risks, observe the following precautions:

• Ensure that temporary pacing and defibrillation equipment is available.

• Avoid direct contact between the ablation catheter and the implanted system.

• Position the return electrode patch so that the electrical current pathway does not pass
through or near the device and leads.

• Always monitor the patient during ablation with at least two separate methods, such as
arterial pressure display, ECG, manual monitoring of the patient’s rhythm (taking pulse)
or monitor by some other means such as ear or finger pulse oximetry, or Doppler pulse
detection.

To avoid or mitigate the effects of oversensing, if appropriate for the patient, initiate
asynchronous pacing by implementing one of the following precautions;

• Suspend tachyarrhythmia detection by using a magnet or a programmer. If a
programmer is used and ablation causes a device reset, the cardiac device resumes
detection. After the ablation procedure, remove the magnet or restore device
parameters.

• If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After the ablation procedure, remove the magnet or restore device
parameters.

Capsule endoscopy, pH capsule procedures – Capsule endoscopy is a procedure in
which a capsule containing a tiny camera is swallowed by the patient to take pictures of the
patient’s digestive tract. Capsule endoscopy and pH capsule procedures should pose no
risk of electromagnetic interference.

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Dental procedures – Dental equipment, such as ultrasonic scalers, drills, and pulp testers,
poses no risk of electromagnetic interference. Keep a cardiac device at least 15 cm (6 in)
away from magnets, such as magnets found in dental office pillow headrests.

Diagnostic radiology (CT scans, fluoroscopy, mammograms, x-rays) – Diagnostic
radiology refers to the following medical procedures:

• Computed axial tomography (CT or CAT scan)

• Fluoroscopy (an x-ray procedure that makes it possible to see internal organs in motion
by producing a video image)

• Mammograms

• X-rays (radiography, such as chest x-rays)

Normally, the accumulated dose from diagnostic radiology is not sufficient to damage the
device. If the device is not directly exposed to the radiation beam, no risk of interference with
device operation occurs. However, if the device is directly in a CT scan beam, see the
following precautions in “CT scan”. Similar interference may be observed for some forms of
high-intensity fluoroscopy.

CT scan – A CT scan is a computerized process in which two-dimensional x-ray images are
used to create a three-dimensional x-ray image. If the device is not directly in the CT scan
beam, the device is not affected. If the device is directly in the CT scan beam, oversensing
may occur for the duration of time the device is in the beam. If the device will be in the beam
for longer than 4 s, to avoid or mitigate the effects of oversensing, if appropriate for the
patient, initiate asynchronous pacing by implementing one of the following precautions:

• Suspend tachyarrhythmia detection by using a magnet or a programmer. After
completing the CT scan, remove the magnet or restore device parameters.

• If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After completing the CT scan, restore device parameters.

Diagnostic ultrasound – Diagnostic ultrasound is an imaging technique that is used to
visualize muscles and internal organs, their size, structures, and motion as well as any
pathological lesions. It also is used for fetal monitoring and to detect and measure blood flow.
Diagnostic ultrasound, such as echocardiogram, poses no risk of electromagnetic
interference. For precautions about therapeutic ultrasound, see “Diathermy treatment
(including therapeutic ultrasound)”.

Diathermy treatment (including therapeutic ultrasound) – Diathermy is a treatment that
involves the therapeutic heating of body tissues. Diathermy treatments include high
frequency, short wave, microwave, and therapeutic ultrasound. Except for therapeutic
ultrasound, do not use diathermy treatments on cardiac device patients. Diathermy
treatments may result in serious injury or damage to an implanted device and leads.
Therapeutic ultrasound is the use of ultrasound at higher energies than diagnostic

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ultrasound to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if
treatment is performed with a minimum separation distance of 15 cm (6 in) between the
applicator and the implanted device and leads.

Electrolysis – Electrolysis is the permanent removal of hair by using an electrified needle
(AC or DC) that is inserted into the hair follicle. Electrolysis introduces electrical current into
the body, which may cause oversensing. Evaluate any possible risks associated with
oversensing with the patient’s medical condition. To avoid or mitigate the effects of
oversensing, if appropriate for the patient, initiate asynchronous pacing by implementing
one of the following precautions:

• Suspend tachyarrhythmia detection by using a magnet or a programmer. After
completing electrolysis, remove the magnet or restore device parameters.

• If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After completing electrolysis, restore device parameters.

Electrosurgery – Electrosurgery (including electrocautery, electrosurgical cautery, and
Medtronic Advanced Energy surgical incision technology) is a process in which an electric
probe is used to control bleeding, to cut tissue, or to remove unwanted tissue. Electrosurgery
used on cardiac device patients may result in, but is not limited to, oversensing, unintended
tissue damage, tachyarrhythmias, device damage, or device malfunction. If electrosurgery
cannot be avoided, consider the following precautions:

• Ensure that temporary pacing and defibrillation equipment is available.

• Use a bipolar electrosurgery system or Medtronic Advanced Energy surgical incision
technology, if possible. If a unipolar electrosurgery system is used, position the return
electrode patch so that the electrical current pathway does not pass through or within
15 cm (6 in) of the device and leads.

• Do not apply unipolar electrosurgery within 15 cm (6 in) of the device and leads.

• Use short, intermittent, and irregular bursts at the lowest clinically appropriate energy
levels.

• Always monitor the patient during electrosurgery. If the ECG tracing is not clear due to
interference, manually monitor the patient’s rhythm (take pulse); alternatively, monitor by
some other means such as ear or finger pulse oximetry, Doppler pulse detection, or
arterial pressure display.

To avoid or mitigate the effects of oversensing, consider the following precautions:

• Suspend tachyarrhythmia detection by using a magnet or a programmer. If a
programmer is used and electrosurgery causes a device reset, the cardiac device
resumes detection. After completing electrosurgery, remove the magnet or restore
device parameters.

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• If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After completing electrosurgery, restore device parameters.

External defibrillation and cardioversion – External defibrillation and cardioversion are
therapies that deliver an electrical shock to the heart to convert an abnormal heart rhythm to
a normal rhythm.

Medtronic cardiac devices are designed to withstand exposure to external defibrillation and
cardioversion. While damage to an implanted system from an external shock is rare, the
probability increases with increased energy levels. These procedures may also temporarily
or permanently elevate pacing thresholds or temporarily or permanently damage the
myocardium. If external defibrillation or cardioversion are required, consider the following
precautions:

• Use the lowest clinically appropriate energy.

• Position the patches or paddles a minimum of 15 cm (6 in) away from the device.

• Position the patches or paddles perpendicular to the device and leads.

• If an external defibrillation or cardioversion is delivered within 15 cm (6 in) of the device,
use a Medtronic programmer to evaluate the device and lead system.

Hyperbaric therapy (including hyperbaric oxygen therapy, or HBOT) – Hyperbaric
therapy is the medical use of air or 100% oxygen at a higher pressure than atmospheric
pressure. Hyperbaric therapies with pressures exceeding 2.5 ATA (approximately 15 m (50
ft) of seawater) may affect device function or cause device damage. To avoid or mitigate
risks, do not expose implanted devices to pressures exceeding 2.5 ATA.

Lithotripsy – Lithotripsy is a medical procedure that uses mechanical shock waves to break
up kidney or gallbladder stones. If the device is at the focal point of the lithotripter beam,
lithotripsy may permanently damage the device. If lithotripsy is required, keep the focal point
of the lithotripter beam a minimum of 2.5 cm (1 in) away from the device. To avoid or mitigate
the effects of oversensing, consider the following precautions:

• Suspend tachyarrhythmia detection by using a magnet or a programmer. After
completing lithotripsy treatment, remove the magnet or restore device parameters.

• If appropriate for the patient, program the device to an asynchronous pacing mode (for
example, DOO). After completing lithotripsy treatment, restore device parameters.

Magnetic resonance imaging (MRI) – An MRI is a type of medical imaging that uses
magnetic fields to create an internal view of the body. Do not conduct MRI scans on patients
who have this device or lead implanted. MRI scans may result in serious injury, induction of
tachyarrhythmias, or implanted system malfunction or damage.

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Radiotherapy – Radiotherapy is a cancer treatment that uses radiation to control cell
growth. When performing radiotherapy, take precautions to avoid oversensing, device
damage, and device operational errors, as described in the following sections:

• Oversensing – If the patient undergoes radiotherapy treatment and the average dose
rate at the device exceeds 1 cGy/min, the device may inappropriately sense direct or
scattered radiation as cardiac activity for the duration of the procedure. To avoid or
mitigate the effects of oversensing, consider these precautions:

– Suspend tachyarrhythmia detection by using a magnet or a programmer. After

completing radiotherapy treatment, remove the magnet or restore device
parameters.

– If appropriate for the patient, program the device to an asynchronous pacing mode

(for example, DOO). After completing radiotherapy treatment, restore device
parameters.

• Device damage – Exposing the device to high doses of direct or scattered radiation from
any source that results in an accumulated dose greater than 500 cGy may damage the
device. Damage may not be immediately apparent. If a patient requires radiation therapy
from any source, do not expose the device to radiation that exceeds an accumulated
dose of 500 cGy. To limit device exposure, use appropriate shielding or other measures.
For patients who are undergoing multiple radiation treatments, consider the
accumulated dose to the device from previous exposures.

Note: Normally, the accumulated dose from diagnostic radiology is not sufficient to
damage the device. See “Diagnostic radiology” for precautions.

Protecta™ XT VR D314VRG

• Device operational errors – Exposing the device to scattered neutrons may cause
electrical reset of the device, errors in device functionality, errors in diagnostic data, or
loss of diagnostic data. To help reduce the chance of electrical reset due to neutron
exposure, deliver radiotherapy treatment by using photon beam energies less than or
equal to 10 MV. The use of conventional x-ray shielding during radiotherapy does not
protect the device from the effects of neutrons. If photon beam energies exceed 10 MV,
Medtronic recommends interrogating the device immediately after radiotherapy
treatment. An electrical reset requires reprogramming of device parameters. Electron
beam treatments that do not produce neutrons do not cause electrical reset of the
device.

Stereotaxis – Stereotaxis is a catheter navigation platform that allows clinicians to steer
catheter-based diagnostic and therapeutic devices throughout the body by using magnetic
navigation. During a stereotaxis procedure, the magnetic field may activate the magnet
detection sensor in the implanted device, which suspends tachyarrhythmia detection. The
device resumes normal programmed operation after the procedure.

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Transcutaneous electrical nerve stimulation (TENS) – TENS (including neuromuscular
electrical stimulation or NMES) is a pain control technique that uses electrical impulses
passed through the skin to stimulate nerves. A TENS device is not recommended for
in-home use by cardiac device patients due to a potential for oversensing, inappropriate
therapy, or inhibition of pacing. If a TENS device is determined to be medically necessary,
contact a Medtronic representative for more information.

Transurethral needle ablation (Medtronic TUNA therapy) – Transurethral needle
ablation is a surgical procedure used for benign prostatic hyperplasia (BPH) in which
precisely focused, conducted radio frequency energy is used to ablate prostate tissue.
Patients with implanted cardiac devices may conditionally undergo procedures that use the
Medtronic TUNA system. To avoid affecting cardiac device function when performing the
TUNA procedure, position the return electrode on the lower back or lower extremity at least
15 cm (6 in) away from the implanted device and leads.

Protecta™ XT VR D314VRG

2.7 Warnings, precautions, and guidance related to electromagnetic interference (EMI) for cardiac device patients

Many cardiac device patients resume their normal daily activities after full recovery from
surgery. However, there may be certain situations that patients need to avoid. Because a
cardiac device is designed to sense the electrical activity of the heart, the device may sense
a strong electromagnetic energy field outside of the body and deliver a therapy that is not
needed or withhold a therapy that is needed. The following sections provide important
information to share with patients about electrical equipment or environments that may
cause interference with their implanted cardiac device.

For additional guidance about EMI, customers can contact the following resources:

• Customers in the United States can contact either of the following telephone numbers:
for pacemakers, contact Medtronic Technical Services at [phone]; for ICDs,
contact Medtronic Technical Services at [phone]. You may also submit
questions to [e-mail] or your Medtronic representative.

• Customers outside of the United States can contact a Medtronic representative.

General EMI guidelines for patients – Patients should observe the following general
guidelines regarding EMI:

• Area restrictions – Before entering an area where signs are posted prohibiting persons
with an implanted cardiac device, such as a pacemaker or ICD, consult with your doctor.

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• Symptoms of EMI – If you become dizzy or feel rapid or irregular heartbeats while using
an electrical item, release whatever you are touching or move away from the item. The
cardiac device should immediately return to normal operation. If symptoms do not
improve when you move away from the item, consult with your doctor. If you have an ICD
and you receive a therapy shock while using an electrical item, release the item or move
away from it, then consult with your doctor.

• Proper grounding of electrical items – To avoid interference from electrical current that
may leak from improperly grounded electrical items and pass through the body, observe
the following precautions:

– Make sure that all electrical items are properly wired and grounded.

– Make sure that electrical supply lines for swimming pools and hot tubs are properly

installed and grounded according to local and national electrical code requirements.

Wireless communication devices – Wireless communication devices include
transmitters that can affect cardiac devices. When using wireless communication devices,
keep them at least 15 cm (6 in) away from your cardiac device. The following items are
examples of such devices:

• Hand-held cellular, mobile, or cordless telephones (wireless telephones); two-way
pagers; personal digital assistants (PDAs); smartphones; and mobile email devices

• Wireless-enabled devices such as laptop, notebook, or tablet computers; network
routers; MP3 players; e-readers; gaming consoles; televisions; DVD players; and
headsets

• Remote keyless entry and remote car starter devices

Household and hobby items with motors or magnets and other items that cause
EMI – Household and hobby items that have motors or magnets or that generate

electromagnetic energy fields could interfere with a cardiac device. Keep a cardiac device at
least 15 cm (6 in) away from the following items:

• Hand-held kitchen appliances, such as electric mixers

• Sewing machines and sergers

• Personal care items, such as corded hand-held hair dryers, corded electric shavers,
electric or ultrasonic toothbrushes (base charger), or back massagers

• Items that contain magnets, such as bingo wands, mechanic’s extractor wands,
magnetic bracelets, magnetic clasps, magnetic chair pads, or stereo speakers

• Remote controller of radio-controlled toys

• Two-way walkie-talkies (less than 3 W)

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The following household and hobby items require special precautions:

• Boat motors – Keep a cardiac device at least 30 cm (12 in) away from electric trolling
motors or gasoline-powered boat motors.

• Electronic body fat scale – Using this type of scale is not recommended for cardiac
device patients because it passes electricity through the body and can interfere with the
device.

• Electronic pet fences or invisible fences – Keep a cardiac device at least 30 cm (12 in)
away from the buried wire and the indoor antenna of electronic pet fences or invisible
fences.

• Home-use electric kilns – Keep a cardiac device at least 60 cm (24 in) away from
home-use electric kilns.

• Induction cook tops – An induction cook top uses an alternating magnetic field to
generate heat. Keep a cardiac device at least 60 cm (24 in) away from the heating zone
when the induction cook top is turned on.

• Magnetic mattress pads or pillows – Items containing magnets can interfere with the
normal operation of a cardiac device if they are within 15 cm (6 in) of the device. Avoid
using magnetic mattress pads or pillows because they cannot easily be kept away from
the device.

• Portable electric generators up to 20 kW – Keep a cardiac device at least 30 cm (12 in)
away from portable electric generators.

• UPS (uninterruptible power source) up to 200 A – Keep a cardiac device at least 30 cm
(12 in) away from a UPS. If the UPS is operating by battery source, keep a cardiac device
at least 45 cm (18 in) away.

Home power tools – Most home power tools should not affect cardiac devices. Consider
the following common-sense guidelines:

• Keep all equipment in good working order to avoid electrical shock.

• Be certain that plug-in tools are properly grounded (or double insulated). Using a ground
fault interrupter outlet is a good safety measure (this inexpensive device prevents a
sustained electrical shock).

Some home power tools could affect cardiac device operation. Consider the following
guidelines to reduce the possibility of interference:

• Electric yard and hand-held power tools (plug-in and cordless) – Keep a cardiac device
at least 15 cm (6 in) away from such tools.

• Soldering guns and demagnetizers – Keep a cardiac device at least 30 cm (12 in) away
from these tools.

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• Gasoline-powered tools and gasoline-powered yard equipment – Keep a cardiac device
at least 30 cm (12 in) away from components of the ignition system. Turn off the motor
before making adjustments.

• Car engine repair – Turn off car engines before making any adjustments. When the
engine is running, keep a cardiac device at least 30 cm (12 in) away from components
of the ignition system.

Industrial equipment – After recovering from implant surgery, you likely will be able to
return to work, school, or daily routine. However, if you will be using or working near
high-voltage equipment, sources of high electrical current, magnetic fields, or other EMI
sources that may affect device operation, consult with your doctor. You may need to avoid
using, or working near, the following types of industrial equipment:

• Electric furnaces used in the manufacturing of steel

• Induction heating equipment and induction furnaces, such as kilns

• Industrial magnets or large magnets, such as those used in surface grinding and
electromagnetic cranes

• Dielectric heaters used in industry to heat plastic and dry glue in furniture manufacturing

• Electric arc and resistance welding equipment

• Broadcasting antennas of AM, FM, shortwave radio, and TV stations

• Microwave transmitters. Note that microwave ovens are unlikely to affect cardiac
devices.

• Power plants, large generators, and transmission lines. Note that lower voltage
distribution lines for homes and businesses are unlikely to affect cardiac devices.

Radio transmitters – Determining a safe distance between the antenna of a radio
transmitter and a cardiac device depends on many factors such as transmitter power,
frequency, and the antenna type. If the transmitter power is high or if the antenna cannot be
directed away from a cardiac device, you may need to stay farther away from the antenna.
Refer to the following guidelines for different types of radio transmitters:

• Two-way radio transmitter (less than 3 W) – Keep a cardiac device at least 15 cm (6 in)
away from the antenna.

• Portable transmitter (3 to 15 W) – Keep a cardiac device at least 30 cm (12 in) away from
the antenna.

• Commercial and government vehicle-mounted transmitters (15 to 30 W) – Keep a
cardiac device at least 60 cm (24 in) away from the antenna.

• Other transmitters (125 to 250 W) – Keep a cardiac device at least 2.75 m (9 ft) away from
the antenna.

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For transmission power levels higher than 250 W, contact a Medtronic representative for
more information.

Security systems – When passing through security systems, follow these precautions:

• Electronic antitheft systems, such as in a store or library, and point-of-entry control
systems, such as gates or readers that include radio frequency identification
equipment – These systems should not affect a cardiac device, but as a precaution, do
not linger near or lean against such systems. Simply walk through these systems at a
normal pace. If you are near an electronic antitheft or entry control system and
experience symptoms, promptly move away from the equipment. After you move away
from the equipment, the cardiac device resumes its previous state of operation.

• Airport, courthouse, and jail security systems – Given the short duration of security
screening, it is unlikely that metal detectors (walk-through archways and hand-held
wands) and full body imaging scanners (also called millimeter wave scanners and
three-dimensional imaging scanners) in airports, courthouses, and jails will affect a
cardiac device. When encountering these security systems, follow these guidelines:

– Always carry your cardiac device ID card. If a cardiac device sets off a metal detector

or security system, show your ID card to the security operator.

– Minimize the risk of temporary interference with your cardiac device while going

through the security screening process by not touching metal surfaces around any
screening equipment.

– Do not stop or linger in a walk-through archway; simply walk through the archway at

a normal pace.

– If a hand-held wand is used, ask the security operator not to hold it over or wave it back

and forth over your cardiac device.

– If you have concerns about security screening methods, show your cardiac device ID

card to the security operator, request alternative screening, and then follow the
security operator’s instructions.

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2.8 Potential adverse events

The potential adverse events associated with the use of transvenous leads and pacing
systems include, but are not limited to, the following events:

• acceleration of tachyarrhythmias (caused by device)

• air embolism

• bleeding

• body rejection phenomena, including local tissue reaction

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• cardiac dissection

• cardiac perforation

• cardiac tamponade

• chronic nerve damage

• constrictive pericarditis

• death

• device migration

• endocarditis

• erosion

• excessive fibrotic tissue growth

• extrusion

• fibrillation or other arrhythmias

• fluid accumulation

• formation of hematomas/seromas or cysts

• heart block

• heart wall or vein wall rupture

• hemothorax

• infection

• keloid formation

• lead abrasion and discontinuity

• lead migration/dislodgement

• mortality due to inability to deliver therapy

• muscle and/or nerve stimulation

• myocardial damage

• myocardial irritability

• myopotential sensing

• pericardial effusion

• pericardial rub

• pneumothorax

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• poor connection of the lead to the device, which may lead to oversensing, undersensing,
or a loss of therapy

• threshold elevation

• thrombotic embolism

• thrombosis

• tissue necrosis

• valve damage (particularly in fragile hearts)

• venous occlusion

• venous perforation

Additional potential adverse events associated with the use of ICD systems include, but are
not limited to, the following events:

• inappropriate shocks

• potential mortality due to inability to defibrillate

• shunting current or insulating myocardium during defibrillation

Patients susceptible to frequent shocks despite medical management could develop
psychological intolerance to an ICD system that might include the following conditions:

• dependency

• depression

• fear of premature battery depletion

• fear of shocking while conscious

• fear that shocking capability may be lost

• imagined shocking (phantom shock)

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Protecta™ XT VR D314VRG

3 Clinical data

3.1 Adverse events and clinical trial data

Information regarding clinical studies and adverse events related to this device is available
at www.medtronic.com/manuals.

The following clinical studies are related to this device:

Atrial Fibrillation Symptoms Mediated by Pacing to Mean Rates (AF SYMPTOMS) –

This study evaluated the long-term effects of Conducted AF Response in patients with atrial
fibrillation and intact atrioventricular (AV) conduction. It provides support for the Conducted
AF Response feature in Protecta XT VR Model D314VRG devices. Note that the Ventricular
Response Pacing (VRP) feature mentioned in the study is called Conducted AF Response
in the Protecta XT VR Model D314VRG devices.

The Enhanced Surveillance of Right Ventricle Lead Integrity Alert (RV LIA) – This
study, which prospectively assessed the performance of the Right Ventricle Lead Integrity
Alert, provided an estimate of the probability of receiving a three-day warning for patients
with a lead fracture. The study provides support for the RV Lead Integrity Alert feature in
Protecta XT VR Model D314VRG devices.

EnTrust clinical study – This clinical study, which evaluated the safety and clinical
performance of the EnTrust ICD system, provides support for the Protecta XT VR Model
D314VRG devices.

FAST study – This clinical study, which evaluated the OptiVol Fluid Monitoring feature in
InSync Marquis devices to corroborate the MIDHeFT clinical data, provides support for the
OptiVol Fluid Monitoring feature in Protecta XT VR Model D314VRG devices.

GEM DR clinical studies – This clinical study, which evaluated the appropriateness of dual
chamber sensing and tachyarrhythmia detection during induced and simulated cardiac
arrhythmias in GEM DR devices, provides support for the Protecta XT VR Model D314VRG
devices.

InSync III Marquis clinical study – This clinical study, which evaluated the Conducted AF
Response feature in the InSync III Marquis devices, provides support for Conducted AF
Response in Protecta XT VR Model D314VRG devices.

Kappa 700 clinical study – This study, which evaluated the safety and clinical performance
of the Kappa 700 pacemakers, provides support for the Right Ventricular Capture
Management feature and other bradycardia pacing features.

Marquis VR Single Chamber ICD study – This clinical study, which evaluated the
operation of the Wavelet Auto-Template Algorithm in the Model 7230 Marquis VR devices,

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provides support for the Wavelet detection feature in Protecta XT VR Model D314VRG
devices.

Medtronic Impedance Diagnostics in Heart Failure Trial (MIDHeFT) – This clinical
study, which demonstrated the use of intrathoracic impedance as a surrogate measure of
fluid status in patients with heart failure, provides support for the OptiVol Fluid Status
Monitoring feature in Protecta XT VR Model D314VRG devices.

Protecta detection performance – This retrospective evaluation was performed using
human rhythms collected from various clinical trials and provides support that the addition of
multiple therapy discriminators in the Protecta products do not affect the overall detection
performance of the Protecta XT VR Model D314VRG devices.

RV Lead Integrity Alert performance retrospective evaluation – This retrospective
evaluation assessed the ability of the RV Lead Integrity Alert feature to provide advance
notice of a Sprint Fidelis lead fracture. The evaluation provides support for the RV Lead
Integrity Alert feature in Protecta XT VR Model D314VRG devices.

RV Lead Integrity Alert Performance retrospective evaluation for non-Medtronic
leads – This retrospective evaluation assessed the performance of the RV Lead Integrity

Alert feature when used with a St. Jude Riata/Durata lead or Boston Scientific Endotak lead.
This evaluation provides information regarding the performance of the RV Lead Integrity
Alert feature in these non-Medtronic lead families.

RV Lead Noise Discrimination VF detection performance – This retrospective
evaluation was conducted using spontaneous rhythms and provides support that the RV
Lead Noise Discrimination algorithm does not impact time to detection in Protecta XT VR
Model D314VRG devices.

Template Matching Morphology (TEMM) study – This clinical study, which evaluated the
functionality of the Template Matching Morphology (TEMM) algorithm, provides support for
the Wavelet detection feature in Protecta XT VR Model D314VRG devices.

TWave Discrimination VF detection performance – This retrospective evaluation was
conducted using induced rhythms and provides support that the TWave Discrimination
algorithm does not impact time to detection in Protecta XT VR Model D314VRG devices.

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Protecta™ XT VR D314VRG

4 Using the programmer

4.1 Establishing telemetry between the device and the programmer

You can establish telemetry between the device and the programmer by using either a
wireless telemetry mode or a nonwireless telemetry mode.

• The Medtronic CareLink Model 2090 Programmer with Conexus telemetry supports
patient sessions using either Conexus wireless telemetry or nonwireless telemetry
using a programming head.

• The Medtronic CareLink Model 2090 Programmer supports patient sessions with
nonwireless telemetry using a programming head.

Refer to the programmer reference guide for information about setting up the programmer for
a patient session.

4.1.1 Using Conexus telemetry

The Medtronic CareLink Model 2090 Programmer with Conexus telemetry is designed to
provide clinicians and patients with an easier and more efficient implant and follow-up
experience. This system uses radio frequency (RF) telemetry for wireless communication
between the implanted device and the programmer in the hospital or clinic. Conexus
telemetry operates within the Medical Implant Communications Service (MICS) band, which
is the only band designated for implantable medical devices. Using the MICS band prevents
interference with home electronics such as microwaves, cell phones, and baby monitors.

Conexus telemetry eliminates the need to have a programming head over the implanted
device for the duration of a programming or follow-up session. At implant, the system allows
you to program the device without having to use a programming head in the sterile field. See
Figure 2.

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Figure 2. Using Conexus telemetry at implant

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During programming and follow-up sessions, the system allows wireless communication
between the device and programmer. See Figure 3.

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Figure 3. Using Conexus telemetry at a follow-up session

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4.1.1.1 Considerations for using Conexus telemetry

When you start a patient session using either wireless or nonwireless telemetry, you must
end the session before changing telemetry modes. The programmer does not operate
simultaneously in wireless and nonwireless telemetry modes.

4.1.1.2 How to activate wireless telemetry

To use Conexus telemetry for a patient session, you need to activate wireless telemetry in
both the programmer and the device.

• To activate wireless telemetry in the programmer, turn the programmer power on. The
programmer starts and the Find Patient window is displayed. Select the “Allow wireless
communication” check box on the Find Patient window. The programmer searches for
compatible activated devices within telemetry range.

• To activate wireless telemetry in the device, briefly place the programming head or
Conexus Activator over the device until the device is identified.

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Upon activation, the programmer searches for activated devices within telemetry range. If a
device senses a signal from the programmer, it sends a signal to the programmer and
remains active for a brief period of time. The programmer then establishes communication
with the device. The Find Patient window is displayed for at least 5 min. If the programmer
touch pen is not used within 5 min, the Find Patient window closes and the Select Model
screen is displayed.

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4.1.1.3 How to use the Find Patient window

The programmer lists all patients with wireless-activated implantable devices within
telemetry range in the Patient Name list within the Find Patient window. Patients are listed in
the order in which they were found by the programmer. The list periodically updates to
include patients with newly activated devices and removes patients with devices that are no
longer active, but the order in which the remaining patients appear in the Patient Name list
does not change. The Find Patient window lists patients for whom a session has not started
or has ended.

4.1.1.4 How to verify reliable telemetry between the device and the programmer

Successful interrogation or programming of the device verifies that reliable telemetry
between the device and the programmer has occurred. When wireless telemetry is first
established during a session, the telemetry status indicator in the upper-left corner of the
programmer task bar changes from the programming head icon to the wireless telemetry
icon shown in Figure 4.

Figure 4. Wireless telemetry icon on the task bar

1 Wireless telemetry icon

The indicator bar on the wireless telemetry icon displays the strength of the wireless
communication signal. Verify that at least 3 of the green lights are illuminated on the indicator
bar to ensure that reliable telemetry has been established between the implanted device and
the programmer.

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4.1.1.5 How to maintain reliable telemetry

You can expect reliable wireless telemetry between the implanted device and the
programmer in a typical examination room or operating room. If the device and programmer
are in the presence of other electrical equipment, the system is designed to maintain
effective communication at distances up to 2 m (6.5 feet) between the device and the
programmer. The system should not interfere with other electronic equipment in the area.

If you are having trouble maintaining consistent, reliable telemetry between a patient’s
implanted device and the programmer, take one or more of the following actions to increase
the number of illuminated lights on the telemetry status indicator:

• Adjust the angle of the programmer screen. The telemetry antenna is part of the
programmer display screen structure, and slight movements of the screen may improve
the telemetry link.

• Change the position of the programmer so that the space between the programmer
screen and the patient is relatively free of obstruction. The optimal position for the
programmer is between the patient and you, so that you are facing the screen and the
patient is beyond the screen facing both you and the programmer.

• Shorten the distance between the programmer and the patient.

• Signal strength may be stronger with the device placed in the patient than if the device
is in the packaging.

• Remove any sources of electromagnetic interference (EMI) that may be affecting the
telemetry signal.

If a session is accidently disrupted by electrical interference, the programmer attempts to
reestablish communication with the device. If communication between the device and
programmer is not reestablished, you must use the Conexus Activator or programming head
to reactivate wireless telemetry in the device to resume or to start a new session.

Note: If you want to use Holter Telemetry to transmit EGM and Marker Channel data during
a Conexus telemetry session, you must first activate Standby mode.

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4.1.1.6 Session inactivity safeguards

If you or the patient leaves the proximity of the programmer for a period of time, the system
provides 2 levels of session inactivity safeguards against unintentional programming.

• In a follow-up session, after 2 min of programmer inactivity (with no screen button
activity), the system displays the patient’s name or ID number and device information
and requires you to confirm that the correct patient is in the follow-up session before you
can process a programming command. You can still interact with the programmer during
this time, but you must confirm any programming and interrogating requests.

• In either an implant or follow-up session, after 2 hours of programmer inactivity (with no
screen button activity) the device transitions to Standby mode.

Standby mode – The system provides a Standby mode for situations in which a period of
inactivity in a patient session is planned. In Standby mode, the device operates in a manner
similar to that in nonwireless telemetry when the programming head is lifted from the device.
Live waveforms are turned off, and the programmer telemetry status indicator shows that
there is no telemetry link. A low level of communication is maintained between the device
and the programmer.

Programmer functions are limited in Standby mode. When the system is in Standby mode it
is possible to start a session with the device, either using the current programmer or another.
If another programmer is used to open a session with the device, end the session with the
current programmer first as the device can be in a session with only one programmer at a
time. Before you attempt to program, interrogate, or conduct testing or emergency actions,
you must verify that the session you are initiating is with the intended patient.

If desired, you can manually activate and deactivate Standby mode.

• To activate Standby mode, select the wireless telemetry icon in the upper-left corner of
the programmer display.

• To deactivate Standby mode, reselect the wireless telemetry icon in the upper-left corner
of the programmer display, or place either the Conexus Activator or the programming
head over the device. After a brief period of time in Standby mode, wireless telemetry is
deactivated within the device and must be reactivated by using either the Conexus
Activator or the programming head.

Note: Standby mode is also deactivated when you attempt to program parameters,
interrogate the device, or conduct testing or emergency operations. The programmer
screen displays the Verify Patient warning window. To deactivate Standby mode and
resume your patient session, verify that the session is with the intended patient, select
the “Allow wireless communication” check box, and select [Continue].

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4.1.1.7 How to maintain patient safety and privacy

To maintain the patient’s safety and privacy during a wireless telemetry session, all other
programmers are locked out from communicating or initiating a session with the patient’s
implanted device. Similarly, implanted devices in other patients are locked out from any
communication or programming occurring during the patient’s session.

When you are using wireless telemetry, the patient’s name is displayed on the Command bar
of the programmer screen. For more information regarding the Command bar, see
Section 4.3, Display screen features, page 53. If the patient’s name has not been entered,
the patient’s ID number is displayed. If the patient’s name and ID number are not entered,
then “(Patient name not entered)” appears on the Command bar. Enter the patient’s name
and ID number as early as possible to assist with patient identification when using wireless
telemetry.

4.1.2 Using nonwireless telemetry

You can use either the Medtronic CareLink Model 2090 Programmer with Conexus telemetry
in nonwireless telemetry mode or the Medtronic CareLink Model 2090 Programmer. You
also need to use a Medtronic Model 2067 or 2067L Programming Head while in this mode.
After you start a patient session using nonwireless telemetry, you must end the session
before you can change to wireless telemetry mode.

4.1.2.1 How to establish nonwireless telemetry

If you are using the Medtronic CareLink Model 2090 Programmer with Conexus telemetry
but choose to use it in the nonwireless mode, make sure that the “Allow wireless
communication” check box on the Find Patient window is not selected. This prevents the
programmer from initiating a wireless telemetry session. If you are using a Medtronic
CareLink Model 2090 Programmer that does not have Conexus telemetry, the check box
does not appear on the Find Patient window. Place the programming head over the device
to establish nonwireless telemetry between the programmer and the device. Successful
interrogation or programming of the device verifies that reliable communication between the
device and the programmer has occurred. When nonwireless telemetry is first established
during a session, the telemetry status indicator in the upper-left corner of the programmer
task bar displays the programming head icon, as shown in Figure 5.

Figure 5. Programming head icon on the task bar

1 Programming head icon

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Note: The programming head contains a magnet that can suspend tachyarrhythmia
detection. When telemetry between the device and programmer is established, detection is
not suspended.

When the programming head is placed over the device and telemetry is established, the
amber light on the programming head turns off, and 1 or more of the green indicator lights on
the programming head illuminate. You can find the optimal position for the programming
head by moving it around the implanted device until the greatest number of green lights
illuminate. Position the programming head so at least 2 of the green lights illuminate in order
to ensure proper telemetry has been established. If the programming head slides off the
patient, the session does not terminate. Place the programming head back over the device
to resume programming or interrogating the device.

Note: More information about the general use of the programming head is available in the
programmer reference guide.

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4.2 Conducting a patient session

The programmer interrogates the patient’s device at the start of a patient session. Because
the programmer collects and stores data on a session-by-session basis, you need to start a
new session for each patient. You must end the previous session before starting a session
with another patient.

4.2.1 Starting a patient session

Caution: A programmer failure (for example, a faulty touch pen) could result in inappropriate

programming or the inability to terminate an action or an activity in process. In the event of a
programmer failure, immediately turn the programmer power off to deactivate telemetry and
terminate any programmer controlled activity in process.

Caution: During a wireless telemetry session, verify that you have selected the appropriate
patient before proceeding with the session, and maintain visual contact with the patient for
the duration of the session. If you select the wrong patient and continue with the session, you
may inadvertently program the wrong patient’s device.

Caution: Do not leave the programmer unattended while a wireless telemetry session is in
progress. Maintain control of the programmer during the session to prevent inadvertent
communication with the patient’s device.

Note: During an initial interrogation, only Emergency programmer functions are available.

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4.2.1.1 How to start a patient session using wireless telemetry

1. Select [Find Patient…] from the Select Model window.

2. Select the “Allow wireless communication” check box on the Find Patient window.

3. Use the Conexus Activator, or briefly place the programming head over the device to
activate wireless telemetry in the device.

Notes:

• When the Conexus Activator is used to activate telemetry in the device, the
programmer launches the patient session without suspending tachyarrhythmia
detection. Placing a magnet near the device, however, suspends tachyarrhythmia
detection.

• When the programming head is used to activate telemetry in the device, the
programmer automatically launches the patient session with tachyarrhythmia
detection suspended. Detection remains suspended as long as the programming
head is over the device. A warning reminds you that tachyarrhythmia detection is
suspended.

4. Select the appropriate patient from the Patient Name list on the Find Patient window.

Note: The programmer lists all patients with wireless-activated implantable devices
within telemetry range.

5. Select [Start].

4.2.1.2 How to start a patient session using nonwireless telemetry

1. Select [Find Patient…] from the Select Model window.

2. If you are using a Medtronic CareLink Model 2090 Programmer with Conexus
telemetry, make sure that the “Allow wireless communication” check box on the Find
Patient window is not selected. If you start a session with the programming head over
the patient’s device and the “Allow wireless communication” check box is selected, the
system initiates a wireless telemetry session and automatically interrogates the device.
If you are using a Medtronic CareLink Model 2090 Programmer that does not have
Conexus telemetry, the “Allow wireless communication” check box does not appear on
the Find Patient window.

3. Place the programming head over the device and the nonwireless session
automatically begins.

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4.2.2 Device and telemetry effects during a patient session

Tachyarrhythmia detection during a wireless telemetry session – If you place a

programming head over the device, the magnet in the programming head always suspends
tachyarrhythmia detection.

Tachyarrhythmia detection during a nonwireless telemetry session – If you place a
programming head over the device and telemetry is established, the magnet in the
programming head does not suspend tachyarrhythmia detection.

Episodes in progress during a wireless telemetry session – If you attempt to initiate a
patient session when a detected arrhythmia episode is in progress, the device treats the
arrhythmia normally. If telemetry has not been established, the magnet inside the
programming head causes the device to suspend detection when the programming head is
placed over the device.

Episodes in progress during a nonwireless telemetry session – After telemetry has
been established and you position the programming head over the device when a detected
arrhythmia episode is in progress, the device treats the arrhythmia normally. If telemetry has
not been established and you position the programming head over the device, the magnet
inside the programming head causes the device to suspend detection.

Capacitor charging during a wireless telemetry session – Interference caused by
capacitor charging may affect telemetry between the device and the programmer. This could
result in a temporary loss of telemetry indicator lights as shown on the programmer task bar,
a temporary loss in Marker transmissions, and temporarily affect the ability to send
programming commands. Ensure that the greatest number of telemetry strength indicator
lights are illuminated on the programmer task bar to help improve telemetry reliability prior to
any manual or automatic capacitor charging.

Capacitor charging during a nonwireless telemetry session – Interference caused by
capacitor charging may affect telemetry between the device and the programmer. The
programming head indicator lights may turn off during charging periods. It is normal for the
lights to turn off on the programming head.

Note: The programming head “P” button is disabled during all EP study and manual system
tests. During tachyarrhythmia inductions, the programming head “I” button is also disabled.

Marker transmissions during a wireless telemetry session – The device continuously
transmits Marker Channel and supplementary marker data while telemetry is established.
The device stops these transmissions when telemetry is interrupted. If Holter Telemetry is
programmed to On, the device transmits telemetry at all times except during a Conexus
telemetry session. If you want to use Holter Telemetry during a Conexus telemetry session,
you must first activate Standby mode.

Marker transmissions during a nonwireless telemetry session – The device
continuously transmits Marker Channel and supplementary marker data while telemetry is

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established and the programming head is positioned over the device. The device stops
these transmissions when you lift the programming head, unless the Holter Telemetry
feature is programmed to On. If Holter Telemetry is programmed to On, the device transmits
Marker Channel and supplementary marker data regardless of the position of the
programming head.

Device longevity and wireless telemetry – In typical patient session and device operation
scenarios, wireless telemetry has no significant effect on device longevity.

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4.2.3 How to interrogate the device during the session

At the start of the patient session the programmer interrogates the device. You can manually
interrogate the device at any time during the patient session by performing the following
steps:

1. Select [Interrogate…] from the Command bar. In a nonwireless session, you may also
interrogate the device by pressing the “I” button on the programming head.

2. To gather information collected since the last patient session, select the Since last
session option from the interrogation window. If you want to gather all of the information
from the device, select the All option.

3. Select [Start].

Note: You cannot manually interrogate the device during an Emergency. You must exit an
Emergency before you can manually interrogate the device.

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4.2.4 Ending a patient session

4.2.4.1 How to end a patient session

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1. To review or print a list of changes made during this session, select Session > Changes
This Session.

a. Review the programming changes made during the patient session.

b. To print a record of the changes, select [Print…].

2. Select [End Session…].

3. To save the session data to a disk, select [Save To Disk…].

4. To end the session and return to the Select Model screen, select [End Now].

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4.3 Display screen features

The programmer display screen is an interface that displays text and graphics. It is also a
control panel that displays buttons and menu options that you can select by using the touch
pen.

The main elements of a typical display screen during a patient session are shown in
Figure 6.

Figure 6. Main elements of a display screen

1 Task bar
2 Status bar
3 Live Rhythm Monitor window

4 Task area
5 Command bar
6 Tool palette

4.3.1 Task bar

The display screen features a task bar at the very top of the screen. You can use the task bar
to note the status of programmer-specific features such as the Analyzer.

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5

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The task bar also includes a graphical representation of the telemetry strength indicator. In
a wireless telemetry session, selecting the wireless telemetry icon breaks the telemetry link.
Selecting it again restores the telemetry link. If you are conducting a nonwireless telemetry
session, the task bar includes a graphical representation of the telemetry strength light array
on the programming head.

Figure 7. Task bar display

1 Telemetry icon and telemetry strength

indicator (wireless telemetry shown)

2 Analyzer icon

3 Device icon

If the SessionSync feature is installed on the programmer, the programmer task bar displays
an icon that indicates the status of the SessionSync feature. For complete information on
viewing the status of the SessionSync feature from the programmer task bar, see
Section 4.14.

4.3.2 Status bar

When the device has been interrogated, you can use the status bar at the top of the display
screen (located immediately below the task bar) to perform some basic functions and to note
the current status of the device.

Figure 8. Status bar display

1 Currently active pacing mode
2 Programmed detection and therapy configuration
3 Buttons used to resume or suspend detection
4 Automatic detection status
5 Indicator that a tachyarrhythmia episode is in progress
6 Either the current episode, therapy, or manual operation status, or the device name and model

number

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4.3.3 Live Rhythm Monitor window

The Live Rhythm Monitor window displays ECG, Leadless ECG, Marker Channel, and
telemetered EGM waveform traces. In addition to waveform traces, the Live Rhythm Monitor
shows the following information:

• The heart rate and the rate interval are displayed if telemetry has been established with
the device.

• The annotations above the waveform trace show the point at which parameters are
programmed.

The Live Rhythm Monitor appears in the partial view by default, as shown in Figure 9. You can
expand this window to its full size by selecting the small square button in the upper-right
corner of the window or by selecting [Adjust…]. For more information about the Live Rhythm
Monitor, see Section 4.11, Working with the Live Rhythm Monitor, page 80.

Figure 9. Live Rhythm Monitor window

1 The location of the square button
2 The location of the [Adjust…] button

4.3.4 Task area

The portion of the screen between the Live Rhythm Monitor window near the top of the
screen and the command bar at the bottom of the screen changes according to the task or
function you select.

One example of a task area is the Parameters screen, which is used to view and program
device parameters as described in Section 4.7, Viewing and programming device
parameters, page 66.

Task areas display differently when you perform other functions such as diagnostics and
system tests.

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Figure 10. Task area of the screen

4.3.5 Tool palette

The buttons and icons along the right edge of the screen are referred to as the “tool palette”.
You can use these tools to display a task or function screen. After starting a patient session,
the tool palette is displayed on all but the Emergency or Live Rhythm Monitor Adjust…
screens, making it quick and easy to move to the desired task or function.

Each of the icons acts like a button. To select an icon, touch the icon with the touch pen. Each
option in the tool palette is described in Table 2.

Table 2. Tool palette options

The [Freeze] button captures a segment of the Live Rhythm Monitor dis­play.

The [Strips…] button accesses the waveform strips saved since the start
of the session.

The [Adjust…] button opens a window of options for adjusting the Live
Rhythm Monitor display.

The Checklist icon opens the Checklist screen for simplified navigation
through a set of follow-up tasks. The Checklist [>>] button navigates to the
next task in the Checklist.

The Data icon displays options for viewing device information and diag­nostic data.

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Table 2. Tool palette options (continued)

The Params icon displays the Parameters screen for viewing and pro­gramming device parameters.

The Tests icon displays options for performing system tests and EP stud­ies.

The Reports icon displays options for printing reports.

The Patient icon displays options for accessing the TherapyGuide screen
or the Patient Information screen.

The Session icon displays options for adjusting preferences, viewing
parameter changes made during the session, saving data, and ending the
session.

4.3.6 Buttons

Buttons, such as those shown in Figure 11, respond when you “select” them by touching
them with the tip of the touch pen.

Figure 11. Display screen buttons

Buttons with a less distinctly shaded label are inactive and do not respond if you select them.

Selecting a button with the touch pen causes one of the following responses:

• Buttons such as the [PROGRAM] button execute a command directly.

• Buttons such as the [Save…] and [Get…] buttons open a window that prompts another
action. The labels on these buttons end with an ellipsis.

A procedure may instruct you to “press and hold” a button. In such cases, touch the tip of the
touch pen to the button and continue to maintain pressure against the button. The button
continues to respond to the touch pen until you remove the touch pen from the button.

4.3.7 Command bar

The bar at the bottom of the screen always shows the buttons for programming Emergency
parameters, interrogating the device, and ending the patient session.

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If the programmer is using wireless telemetry, the patient may be identified on the command
bar of the programmer screen. Depending on the programmed patient information, one of
the following text fields appears:

• the patient name

• the patient ID, if the patient name was not entered

• the message “(Patient name not entered)”, if neither the name nor the ID was entered

Note: The [Interrogate…] and [End Session…] buttons do not appear on the Emergency
screen.

Figure 12. Command bar

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4.4 Delivering an emergency tachyarrhythmia therapy

You can use emergency defibrillation, cardioversion, and fixed burst pacing therapies to
quickly treat ventricular tachyarrhythmia episodes during a patient session. Emergency
defibrillation therapy delivers a high-voltage biphasic shock at the selected energy level.
Emergency cardioversion therapy also delivers a high-voltage biphasic shock, but it must be
synchronized to a ventricular event. Emergency fixed burst pacing therapy delivers
maximum output pacing pulses to the ventricle at the selected interval.

4.4.1 Considerations for emergency tachyarrhythmia therapies

Tachyarrhythmia detection during emergency tachyarrhythmia therapies – The

device suspends the tachyarrhythmia detection features when emergency defibrillation,
cardioversion, or fixed burst pacing therapies are delivered. Select [Resume] to reenable
tachyarrhythmia detection.

Temporary parameter values – Emergency tachyarrhythmia therapies use temporary
parameter values that do not change the programmed parameters of the device. After the
tachyarrhythmia therapy is complete, the device reverts to its programmed parameter
values.

Aborting an emergency tachyarrhythmia therapy – You can immediately terminate an
emergency defibrillation or emergency cardioversion therapy by selecting [ABORT]. To stop
an emergency fixed burst therapy, remove the touch pen from [BURST Press and Hold].

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4.4.2 How to deliver an emergency tachyarrhythmia therapy

1. Establish telemetry with the device.

2. Select [Emergency].

3. Select the type of emergency therapy to deliver: Defibrillation, Cardioversion, or Fixed
Burst.

4. Accept the therapy parameters shown on the screen, or select new values.

5. For defibrillation and cardioversion therapy, select [DELIVER]. For fixed burst therapy,
select [BURST Press and Hold] and hold the touch pen over the button for as long as
you want to deliver the therapy.

4.5 Enabling emergency VVI pacing

You can use emergency VVI pacing to quickly enable 70 bpm, high-output ventricular pacing
to restore ventricular support in an emergency situation.

4.5.1 Considerations for emergency VVI pacing

Parameter values – Emergency VVI pacing reprograms pacing parameters to emergency

settings. See Section B.1, Emergency settings, page 340, for a list of the emergency VVI
parameter settings. To terminate emergency VVI pacing, you must reprogram pacing
parameters from the Parameters screen.

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4.5.2 How to enable emergency VVI pacing

1. During a patient session, establish telemetry with the device.

2. Press the red mechanical emergency VVI button on the programmer. Emergency VVI
pacing is enabled, and the programmer displays the Emergency screen.

Note: You can also enable emergency VVI pacing by selecting the on-screen [Emergency]
button. To do so, perform the following steps.

1. Establish telemetry with the device.

2. Select [Emergency].

3. Select VVI Pacing.

4. Select [PROGRAM].

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4.6 Streamlining implant and follow-up sessions with Checklist

Checklist allows you to catalog and list tasks that are performed during implant and follow-up
sessions. You start with the first task and continue through each task in sequential order.
When you select a task in the checklist, the programmer displays the screen associated with
the task. When you complete the task, you can either proceed directly to the screen
associated with the next task in the checklist or return to the checklist. Two standard
checklists are provided: the Medtronic Standard Implant checklist and the Medtronic
Standard Followup checklist. In addition to these standard checklists, you can create
customized checklists.

4.6.1 How to select a checklist

1. Select the Checklist icon and review the tasks in the Task list for that checklist.

1

2. To choose a different standard or custom checklist, select the desired checklist from the
Checklist field.

1

When starting a new session, the checklist used during the last programming session becomes the active
checklist.

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4.6.2 How to use a checklist

1. To start using the checklist, select either [Go To Task] or the Checklist double-arrow [>>]
button.

2. Perform the selected task from the Task list.

• To continue to the next task, select [>>] next to the Checklist icon.

• To perform a task out of order or to repeat a task from the selected checklist, first
select the Checklist icon. Next, select the task from the Task list, and select either
[Go To Task] or [>>].

The Checklist screen displays check marks next to the names of any programmer screens
that were visited during a session. These check marks provide a general indication of the
tasks that were performed during a session.

2

2

You can select a task whether it is marked with a check mark or not. If you perform the last task in a checklist,
the [>>] and the [Go To Task] buttons are inactive. You can still select an earlier task from the Checklist screen
and use [>>] to cycle through all the tasks that come after the task you selected.

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4.6.3 How to create a custom checklist

1. Select the Checklist icon.

2. Select [New…] from the Checklist screen.

3. Select the tasks in the “Select from these tasks” box on the left to create a custom
checklist.

4. The selected tasks appear at the end of the checklist in the “Tasks in this checklist” box
on the right. Tasks can be added more than once to a custom checklist. To place a new
task in a position other than at the end of the checklist, highlight the task that the new
task should follow, and select the new task. The new task appears below the highlighted
task in the “Tasks in this checklist” box.

5. To delete a task, select the task in the “Tasks in this checklist” box and select [Delete
Task].

6. Select the “Checklist name” field, and enter a name for the checklist.

7. Select [Save].

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4.6.4 How to edit a custom checklist

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1. Select the Checklist icon.

2. Select the custom checklist to edit.

3. Select [Edit…].

4. Select the tasks in the “Select from these tasks” box on the left to add new tasks to the
list in the “Tasks in this checklist” box on the right. Tasks can be added more than once
to a custom checklist.

5. Each selected task appears at the end of the edited checklist. To place a new task in a
position other than at the end of the edited checklist, highlight the task that the new task
should follow, and select the new task. The new task appears below the highlighted task
in the edited checklist.

6. To delete a task, select the task in the “Tasks in this checklist” box and select [Delete
Task].

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7. To rename the edited checklist, select the “Checklist name” field, and enter a new name
for the list.

8. Select [Save].

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4.6.5 How to delete a custom checklist

1. Select the Checklist icon.

2. Select the custom checklist that you want to delete from the Checklist menu.

3. Select [Delete]. A window appears, asking you to confirm that you want to delete the
selected checklist.

4. Select [Delete] to delete the selected checklist or [Cancel] to cancel the delete
procedure.

Note: After a custom checklist is deleted it cannot be restored.

Note: The Medtronic Standard Followup and Medtronic Standard Implant checklists cannot

be edited or deleted, so [Edit…] and [Delete] are unavailable when these checklists are
selected.

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Parameter Interlock exists

Parameter warning exists

Adaptive parameter

Medtronic nominal parameter value

Programmed parameter value

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4.7 Viewing and programming device parameters

The Parameters screen is used for viewing and programming parameters that control device
functions and data collection. All device parameters that you can view and program appear
as “active fields” in the task area. Active fields, which appear as unshaded boxes next to
parameter names, respond to the touch pen. Some active fields pertain to only 1 parameter,
while other fields provide access to groups of parameters. If a parameter cannot be
programmed, no active field appears next to its name. All permanent parameter changes
can be programmed at the Parameters screen.

After you select new values for parameters, the new values are designated as pending
values. A field containing a pending value has a dashed rectangle as its border. Values
remain pending until they are programmed to device memory.

4.7.1 Understanding the symbols used on the Parameters screen

Certain combinations of parameter values are restricted because they are invalid or result in
undesirable interactions. The programmer recognizes these combinations and may not
allow programming until all parameter conflicts are resolved and all parameter selection
requirements are met. A symbol that provides the status of a parameter value appears next
to the value in the selection window. The following symbols can appear next to a parameter
value.

Figure 13. Symbols that appear with parameter values

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Parameter interlock exists – When an interlock symbol appears next to a parameter value,
it indicates that the parameter value conflicts with the setting of another present or pending
value. Select another value or resolve the conflicting parameter value before programming
the parameter.

Parameter warning exists – When an exclamation point enclosed in a triangle appears
next to a parameter value, a warning message is available regarding that value. The
message can be viewed either by selecting the message button or by reselecting that
parameter. In the latter case, the warning is displayed as a warning note in the selection
window. These parameter values can be programmed.

Adaptive parameter – When the adaptive symbol appears next to a parameter value on the
Parameters screen, it indicates that the programmed value can be changed automatically by
the device. The symbol does not necessarily indicate that the parameter value has been
adapted from a previously programmed value, only that it is able to be adapted.

Medtronic nominal parameter value – When the “n” symbol appears next to a parameter
value, it indicates that the value is the Medtronic nominal value.

Programmed parameter value – When the “P” symbol appears next to a parameter value,
it indicates that the value is the programmed value.

The programmer may display a message button next to the [PROGRAM] button that, when
selected, provides access to additional information about the pending parameters. The
message button has one of the symbols described in Table 3. When the message button is
selected, the programmer opens a second window displaying one or more messages.

Table 3. Symbols that appear on the message button

Symbol Explanation

Parameter interlock message

Parameter warning message

Parameter informational message

Parameter interlock message – This button indicates that a parameter interlock exists.
Programming is restricted until you resolve the conflict. Select this button for a message that
describes the conflict.

Parameter warning message – This button indicates that there is a warning associated
with programming one or more of the pending parameter values. Select this button to view
the warning message and recommendations.

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Parameter informational message – This button indicates that there is an informational
message regarding one or more of the parameter values. Select this button to view the
message.

If there are multiple messages regarding the pending parameter values, the most significant
message determines the symbol that appears on the button.

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4.7.2 How to access parameters with 2 values

If a parameter has only 2 values (such as Off and On), selecting the parameter field makes
the alternate value a pending value.

1. Select a parameter field that contains only 2 values. For example, a parameter value
that switches from On to Off (or vice versa).

2. Select [PROGRAM] to program the new value to the device memory.

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4.7.3 How to access parameters with more than 2 values

If a parameter has more than 2 values, a window opens when you select the parameter field
and displays a set of values for that parameter.

1. Select a parameter field that contains more than 2 values. A window opens showing
available values for that parameter.

2. Select a new value from this window. This new value displays as a pending value, and
the window showing available values for that parameter closes. You can also select
[Close] to close the window without changing the original value of the parameter.

3. Select [PROGRAM] to program the new value to the device memory.

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4.7.4 How to access a group of related parameters

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1. Select a parameter or a parameter field that ends with an ellipsis or a parameter field
that contains a list of parameter names. A screen appears that displays related
secondary parameter fields. In the example shown, Data Collection Setup… was
chosen.

2. Select new values for the desired secondary parameters. New values display as
pending values.

3. Select [OK] to close the secondary parameters screen and return to the Parameters
screen.

4. Select [PROGRAM] to program the new values to device memory.

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4.8 Saving and retrieving a set of parameter values

Custom sets of parameter values can be saved on the programmer hard drive and retrieved
either in the current patient session or in subsequent patient sessions. This allows you to
save and quickly access a custom set of parameter values for a particular clinical situation.
For example, you may want to save a set of parameter values for an initial implant setting, for
a specific disease state, or for situations in which you need to repeatedly program a
particular set of parameters.

The [Save…] button opens a window where you can assign a name to the set of parameter
values presently displayed by the Parameters screen. A saved parameters set can include
both programmed and pending values. The [Get…] button opens the Get Parameter Set
window to retrieve a Medtronic Nominals parameter set, an Initial Interrogation parameter
set, or a custom parameter set.

4.8.1 How to save a set of parameter values

1. Select the Params icon. Make the desired parameter selections.

2. Select [Save…] to open the Parameter Set Name window.

3. Type a name for the parameter set, and select either [OK] or [ENTER].

4. If a parameter set exists with that name, you either need to confirm that you want to
replace the existing set with a new set, or you need to change the name of the new set
of parameters.

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4.8.2 How to retrieve a set of parameter values

1. Select the Params icon.

2. Select [Get…] to open the Get Parameter Set window.

3. Select the parameter set you want to retrieve.

4. Select [Set Pending].

5. Optionally, to remove an unneeded parameter set from the list, select the parameter set
and select [Delete].

You can select the following options from the Get Parameter Set window:

• Medtronic Nominals: Values chosen as nominal values for the device by Medtronic. The
Medtronic Nominals cannot be customized or deleted.

• Initial Interrogation Values: The permanently programmed parameter values as
determined by the first interrogation of the device during the patient session.

• Custom sets of values: All custom sets of values that were saved previously.

4.9 Using TherapyGuide to select parameter values

Caution: TherapyGuide does not replace a physician’s expert judgment. The physician’s

knowledge of the patient’s medical condition goes beyond the set of inputs presented to
TherapyGuide. The physician is free to accept, reject, or modify any of the suggested
parameter values.

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TherapyGuide offers a simple clinically-focused method to obtain suggested parameter
values. At implant or at an early follow-up appointment, information can be entered about the
patient’s clinical conditions. Based on those inputs the programmer suggests parameter
values. The suggestions are based on clinical studies, literature, current practice, and
physician feedback.

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4.9.1 Operation of TherapyGuide

The patient’s clinical conditions are entered in the TherapyGuide window, which is accessed
from the Parameters screen or by selecting Patient > TherapyGuide.

Figure 14. TherapyGuide window

Based on a set of selected clinical conditions, TherapyGuide provides suggested values for
many programmable parameters. The clinical conditions influencing these parameter
suggestions are shown in Table 4. This table presents an overview, but the Rationale window
shows how the suggested values for parameters relate to specific settings for the clinical
conditions.

If a parameter is not influenced by the clinical conditions, TherapyGuide may either
recommend the Medtronic nominal value for that parameter or make no recommendation.

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If the suggested value for a parameter is different than the programmed value, the parameter
value appears as a pending value. If the suggested value is identical to the programmed
value, it does not appear as a pending value.

Table 4. How programming suggestions are determined

Programming suggestions Clinical conditions

VF Detection VT/VF

Slowest VT

VT Detection VT/VF

Slowest VT

VT Monitor Treated Cutoff

Pacing Mode Atrial Status

AV Conduction

Lower Rate Atrial Status

AV Conduction
Date of Birth

Rate Response
(including Upper Sensor Rate)

a

The Treated Cutoff equals the VT detection interval if VT Detection Enable is On.

Atrial Status
Heart Failure
Date of Birth
Activity Level

a

Otherwise the Treated Cutoff is the VF detection interval.

4.9.2 Considerations for TherapyGuide

TherapyGuide and the Patient Information screen – The clinical conditions can also be

programmed into device memory from the Patient Information screen. Refer to Section 4.10,
Viewing and entering patient information, page 76.

Last Update status – The date indicates when changes in clinical conditions were last
programmed into device memory.

Printing the clinical conditions – The clinical conditions can be printed from the Patient
Information screen. The clinical conditions are also included in the Initial Interrogation
Report and in the Save to Disk file.

Appearance of the [TherapyGuide…] button – The appearance of the [TherapyGuide…]
button changes about 10 days after implant.

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4.9.3 How to obtain a set of suggested values

1. On the Parameters screen, select [TherapyGuide…] to open the TherapyGuide
window.

2. For each clinical condition, select the field next to the condition and choose one of the
listed inputs.

Note: If you want to program only the choices for clinical conditions without
programming any parameter changes into device memory, select [Close] and
[PROGRAM].

3. After selecting the clinical conditions, select [Get Suggestions]. The TherapyGuide
window closes, and suggested changes to parameter values appear as pending values
on the Parameters screen.

Note: Information is stored in device memory only after you select [PROGRAM] on the
Parameters screen.

Note: If you select [Undo] on the Parameters screen, all pending parameter values and
the pending clinical conditions are cleared.

4. Review the settings and verify that the new settings are appropriate for the patient.

5. To adjust any of the pending values, select [Undo Pending] within the parameter value
window, or select a different parameter value. Repeat this step to adjust other
parameter values as desired.

6. Select [PROGRAM] to enter the pending parameter values and the pending clinical
conditions into device memory.

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4.9.4 How to view the rationale for TherapyGuide suggestions

1. On the Parameters screen, select [TherapyGuide…] to open the TherapyGuide
window.

2. Select [Rationale…] to open the Rationale window.

3. Select [Close] twice to return to the Parameters screen.

4.10 Viewing and entering patient information

Devices can store patient-related information that you can view and print during a patient
session. This information is typically programmed into the device at the time of implant, but
it can be revised at any time.

When you enter the patient’s clinical conditions (Date of Birth and History) and program them
into device memory, they are available to the TherapyGuide feature. Likewise, this same
information programmed through the TherapyGuide feature displays in the Patient
Information screen. For more information, see Section 4.9, Using TherapyGuide to select
parameter values, page 72.

The patient’s name and ID and the device serial number are printed on all full-size and strip
chart reports. If the programmer is using wireless telemetry, the patient is also identified at
the bottom of the programmer screen, either by the patient’s name or by the patient ID (if the
patient’s name was not entered).

Note: The Patient Information screen should not be used in the place of the patient’s medical
chart (refer to Section 1.1.6, Notice, page 17 in the Introduction).

If you enter text that does not fit in the parameter display area, the entry is shortened. The full
entry is visible on the Patient Information Report. When displayed or printed from other
screens, the text entry may be shortened.

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If you start a concurrent Model 2290 Analyzer session during the device session, you can
export analyzer lead measurements. The exported measurements appear as pending
parameter values in the Implant window, which is accessed from the Patient Information
screen. These pending values are programmed from the Patient Information screen.

Table 5. Description of the patient information

Information field Description and required action

Patient Enter the patient’s name (up to 30 characters).

ID Enter the patient ID (up to 15 characters).

Date of Birth Select the patient’s date of birth.

Serial Number (not selectable) Displays the serial number of the implanted device.

Lead 1…
Lead 2…
Lead 3…

Implant… Either export lead data from the Model 2290 Analyzer, or enter lead

Notes Enter notes about the patient or other information.

History… Enter the patient’s clinical conditions. This information is made

EF, on Select the ejection fraction from a table of values in the first field,

Physician
Phone

Hospital Select the hospital name from a list. If it is not listed, add it to the list,

Last Update (not selectable) Displays the date of the last Patient Information update.

Enter detailed information for up to 3 leads:
Select the Model, Position, and Manufacturer from lists of options.
Enter the Serial Number and Implant Date.

data using the submenus. Enter the results of defibrillation testing.

available to TherapyGuide.

and enter the date in the second field.

Select the physician’s name and phone number from a list. If they
are not listed, add them to the list, and select them.

and select it.

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4.10.1 How to view and enter patient information

1. Select Patient > Patient Information. The Patient Information screen is displayed.

2. Select each text field to enter or change its content.

3. Enter the implant information by selecting the Implant… field and performing the
following steps:

a. Enter the measurements from defibrillation testing and indicate the test method.

b. Enter lead data measured with the Analyzer. Then select [OK].

Note: If an implant procedure is in progress, consider making the measurements in
a concurrent analyzer session. Measurements can be exported directly to the
Implant window (see Section 4.10.2 for instructions). Otherwise, select a value for
each parameter.

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4. To enter the patient’s clinical conditions, which are made available to TherapyGuide,
perform the following steps:

a. Select the Date of Birth field, enter the date, and select [OK].

b. Select the History… field to open the History window. Enter the appropriate clinical

conditions, and select [OK].

Protecta™ XT VR D314VRG

5. Select the Physician (or Phone) and the Hospital fields, and select this information from
the lists. To add new information to a list, select [Modify List…] and [Add…]. Type in your
addition and select [OK].

6. When all of the information has been entered, select [PROGRAM].

4.10.2 How to export saved lead measurements to the Implant window

When analyzer and device sessions are running concurrently, you can export the saved lead
measurements from the analyzer session into the Implant window in the device session.

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1. From the device session, launch a new analyzer session by selecting the Analyzer icon,
which is located on the taskbar.

2. Make the desired lead measurements. Identify the measurements as the RV lead type
when you save them.

3. Select [View Saved…].

4. Select which saved measurement to export. You can select only one measurement.

5. Select [Export]. The selected settings are exported to the Implant window in the device
session.

6. When you are finished, select [Close].

7. Return to the device session by selecting the Device icon on the task bar.

The data is mapped to the RV column in the Implant window. As described in
Section 4.10.1, you can add or change an exported measurement by selecting a field in the
Implant window. The exported value is programmed from the Patient Information screen.

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4.11 Working with the Live Rhythm Monitor

The Live Rhythm Monitor window displays ECG, Leadless ECG (LECG), Marker Channel
with marker annotations, and telemetered EGM waveform traces on the programmer screen.
The Live Rhythm Monitor window also displays the patient heart rate and interval in the
upper-left corner of the window. You can view live waveform traces, freeze waveform traces,
record live waveform traces from the programmer’s strip chart recorder, and recall any saved
waveform strips prior to ending a patient session.

By default, the Live Rhythm Monitor appears in partial view. You can expand this window to
its full size by selecting the small square button in the upper-right corner of the window or by
selecting the [Adjust…] button. Waveform traces display depending on which waveform
source is selected and how waveform traces have been arranged in the full-screen view.

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4.11.1 Viewing live waveform traces

The Live Rhythm Monitor can display up to 7 different waveforms during a patient session:

• The Leadless ECG (LECG) waveform displays an approximation of a surface ECG
signal through the Can to SVC source. The Can to SVC source is available only when an
SVC coil is present. This signal is telemetered from the device and is selected from the
programmable LECG source. You can choose the source of LECG when you set up data
collection. For more information, see Section 6.8, Viewing Arrhythmia Episodes data
and setting data collection preferences, page 160.

• The ECG Lead I, ECG Lead II, and ECG Lead III waveforms display ECG signals that are
detected using skin electrodes attached to the patient. The ECG cable attached to these
electrodes must be connected to the programmer.

• The EGM1, EGM2, and EGM3 signals are telemetered from the device and are selected
from programmable EGM sources. You can choose the sources of EGM1, EGM2, and
EGM3 when you set up data collection. The programmer cannot display or record an
EGM waveform trace until the current EGM Range setting has been interrogated from
the device. See Section 6.8, Viewing Arrhythmia Episodes data and setting data
collection preferences, page 160 for more information about EGM sources.

4.11.1.1 How to select and adjust the waveforms

You can use the waveform adjustment button bar to change the appearance of the
waveforms in view.

1. Select the up arrow button to increase the size of the waveform trace.

2. Select the normalize button to restore the waveform trace to its default size.

3. Select the down arrow button to decrease the size of the waveform trace.

4. Select the forward arrow button to choose which waveform trace to display.

5. Select the waveform print selection button to select the waveform trace for printing. You
can select up to 2 waveform traces for printing.

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4.11.1.2 How to change the appearance of the waveform

You can use the Adjust window to make additional changes to the waveform display.

1. Select [Adjust…] to display the full screen Live Rhythm Monitor and the Adjust window.

2. Adjust the size, source, and print selection options for each waveform trace using the
waveform adjustment button bar.

3. Select the color button to change the color of a waveform.

4. Select or clear the Clipping, ECG Filter, and Show Artifacts check boxes as desired.

• Clipping truncates the tops and bottoms of waveform traces at a 22 mm boundary.

• ECG Filter changes the bandwidth of waveforms to improve the clarity of the
displayed ECG in the presence of interference. (Select the check box to set the
bandwidth to 0.5 to 40 Hz, or clear the check box to set the bandwidth to 0.05 to
100 Hz.)

• Show Artifacts displays pacing artifacts superimposed over waveform traces.

5. Select a Sweep Speed if desired. Sweep Speed controls how quickly the waveform is
drawn across the display. Selecting a fast Sweep Speed produces a wide waveform.
Selecting a slow Sweep Speed produces a narrow waveform. Sweep Speed can be set
to 12.5; 25; 50; or 100 mm/s.

6. Select [Normalize] to equalize the spacing between the waveform traces and to resize
each trace to its default setting.

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V
S

V
P

E
R

V
R

Ventricular pace

Ventricular

sense

Ventricular

refractory sense

Marker buffer full

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7. Select the calibrate button to add a reference signal to the analog output, the screen,
and the real-time strip recorder.

8. When you are finished making adjustments, select [OK].

4.11.1.3 How to interpret Marker Channel annotations and symbols

Marker Channel annotations appear as 2 characters above or below the Marker Channel
waveform trace. These annotations indicate events such as pacing, sensing, detection, and
delivered therapies.

Real-time waveform recordings also display symbols that appear above or below their
associated Marker Channel annotations. The symbols sometimes appear compressed
when printed, depending on the printout speed of the programmer strip chart recorder.

See the figures that follow for examples of Marker Channel annotations and symbols.

Note: Any interruption in telemetry with the device may result in missing marker annotations
and symbols on the waveform trace display.

Figure 15. Pacing Marker Channel annotations and symbols

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T
S

T
F

T
D

V
T

F
D

T
P

T •
F

T
F •

F
S

C
E

C
D

V
P

VT sense FVT sense via VTFVT sense via

VF

VF sense

VT detection FVT detection VF detection VT monitor

detection

Ventricular

tachy pace

50 Hz Burst

induction

Charge end

Cardioversion/

defibrillation

pulse

Medtronic Protecta™ XT VR D314VRG

Figure 16. Ventricular detection and therapies Marker Channel annotations and symbols

4.11.2 Recording live waveform traces

At any time during a patient session, you can record a continuous, live waveform trace of the
patient’s ECG, LECG, and EGM3 on the programmer strip chart recorder.

Note: Because the printed waveform strip is of a higher resolution than the programmer
display, the printed waveform strip may show artifacts and events that do not appear on the
programmer display.

A printout of the live waveform trace includes the following information:

• ECG, LECG, and EGM traces

• an indication of an executed command when confirmation of the command is received

• test values during system tests

3

The programmer cannot display or record an EGM or LECG trace until the device has been interrogated.

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• telemetry markers that show telemetry from the programmer to the device
(programming the device) and telemetry from the device to the programmer (confirming
the programming)

• Decision Channel annotations. See Section 6.8, Viewing Arrhythmia Episodes data and
setting data collection preferences, page 160, for more information about Decision
Channel annotations.

Printing a report while recording a live waveform trace – If you select an option from the
Print menu while recording a live waveform trace, the report goes to the print queue.
Alternatively, if you start recording a live waveform trace while the programmer is printing a
report, the report stops printing and returns to the print queue.

Note: This interruption to printing applies only to reports printed on the programmer strip
chart recorder. Printing to a separate printer is not affected.

EGM or LECG Range – The programmer cannot display or record an EGM or LECG
waveform trace until the current EGM Range or LECG Range setting has been interrogated
from the device. If you program an EGM Range or LECG Range setting during a recording,
the programmer marks the change with a vertical dotted line on the paper recording.

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4.11.3 Freezing live waveform traces

The Freeze feature enables you to freeze the last 15 s of all live waveform traces displayed
in the expanded Live Rhythm Monitor window.

You can use controls in the frozen strip viewing window to perform the following functions:

• View earlier or later portions of the strip by using the horizontal scroll bar.

• See frozen waveform strips that are not visible in the window by using the vertical scroll
bar.

• Measure a time interval with on-screen calipers.

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Figure 17. Interpreting the frozen strip viewing window

1 The [Freeze] button freezes a live waveform trace and displays it in the frozen strip viewing window

on the programmer screen.
2 The [Adjust…] button opens the Adjust window for the strip viewer.
3 The Adjust window offers display options for the strip viewer, which is similar to the Adjust window

for the Live Rhythm Monitor.
4 The Waveform adjustment button bar allows you to normalize the trace, resize the trace, and

change the waveform source.
5 The on-screen calipers define time intervals.
6 The Arrow buttons move the on-screen calipers to show the beginning and the end of a time

interval.
7 The Calipers measurement is the time interval between the on-screen calipers.
8 The [Strips…] button opens a list of other frozen strips.
9 The [Save] button saves the on-screen frozen strip.

10 The [Delete] button deletes the on-screen frozen strip (if it was saved).
11 The [Print…] button prints the on-screen frozen strip.
12 The [Close] button closes the frozen strip viewing window.

4.11.4 Recalling waveform strips

Before ending the patient session, you can recall any waveform strip collected and saved
during the session in order to view, adjust, and print the waveform strip.

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4.11.4.1 How to recall a waveform strip

1. Select [Strips…] in the tool palette or in the strip viewer.

2. Select a strip to view.

3. Select [Open]. The strip viewer displays the selected strip.

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4.12 Expediting follow-up sessions with Leadless ECG

An analysis of a patient’s real-time ECG signal is an important part of most follow-up
assessments. Connecting surface leads to the patient and acquiring an acceptable ECG
signal can be a time consuming part of a follow-up session. Additionally, connecting surface
leads to a patient requires that the patient be present in the clinic.

4.12.1 System solution: Leadless ECG

Leadless ECG is designed to simplify and expedite patient follow-up sessions by providing
an alternative to obtaining an ECG signal without the need to connect surface leads to the
patient. Leadless ECG is available in the clinic, and at remote locations where the CareLink
Network is available.

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Leadless ECG provides a far-field view of cardiac activity without connecting leads to the
patient. You can view the Leadless ECG waveform trace on the Live Rhythm Monitor window
(see Section 4.11, Working with the Live Rhythm Monitor, page 80), store the Leadless ECG
waveform trace as one of two EGM signals in episode records (see Section B.6, Data
collection parameters, page 350), and print the Leadless ECG waveform trace.

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4.12.2 Operation of Leadless ECG

The Leadless ECG (LECG) waveform displays an approximation of a surface ECG signal
through the Can to SVC source. The Can to SVC source is available only when an SVC coil
is present. This signal is telemetered from the device and is selected from the programmable
LECG source. You can choose the source of the LECG when you set up data collection.

The Leadless ECG (LECG) waveform trace is available for viewing, recording, and printing
from the Live Rhythm Monitor window. Select LECG from the waveform source button on the
waveform adjustment button bar to display the Leadless ECG waveform trace. For more
information, see Section 4.11, Working with the Live Rhythm Monitor, page 80. You can
display up to 4 different EGM waveform traces, including the LECG waveform trace, on the
Live Rhythm Monitor window.

4.13 Saving and retrieving device data

The programmer allows you to save interrogated device data from a patient session to a
diskette. Later, while no patient session is in progress, you can use the Read From Disk
application on the programmer to retrieve, view, and print data saved on the diskette.

4.13.1 Saving device data to a diskette

4.13.1.1 Preparing to save data to a diskette

The diskette must satisfy the following requirements:

• It must be a formatted, IBM-compatible, 90 mm (3.5 in) diskette.

• Its capacity must be 720 KB (DS, DD) or 1.44 MB (DS, HD).

If you save data to a diskette that is corrupt or is not IBM-formatted, the programmer may
become unresponsive. If this occurs, remove the diskette, and turn the programmer off and
then on again. Normal operation should resume. Please inform your Medtronic
representative of this occurrence.

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4.13.1.2 Considerations for saving device data to a diskette

Emergency functions while saving – During the save operation, the [Emergency] button

remains displayed, and all Emergency functions are available. If a disk error occurs during a
save, there may be a delay in initiating the Emergency screens. Therefore, it is suggested
that you not save to disk during EP studies or when it is possible that Emergency functions
will be needed immediately. If an Emergency function is used during a save operation, the
device aborts the save operation.

Interrogate first – Interrogate the device before saving data to a diskette because the
programmer saves only the data it has interrogated. If you want to save a record of all the
information from the device, select the All option from the interrogation window. Selecting the
All option provides more data for analysis if an issue needs to be investigated.

4.13.1.3 How to save device data to a diskette

1. Select [Interrogate…] to interrogate the device.

2. Select Session > Save to Disk….

3. Insert a diskette into the programmer diskette drive.

4. Select [Save].

You also have the option to Save to Disk when you select [End Session…].

4.13.2 Retrieving device data from a diskette

When the programmer has read the data that was saved during a patient session, it presents
the information in a read-only view. In the read-only view, the data is presented in a slightly
different way than what is seen in a live session. No Live Rhythm Monitor is displayed
because this is not a live session. Instead, the Live Rhythm Monitor is replaced with the
device model and the words Read From Disk. While in the Read From Disk application, the
programmer allows you to view the saved data, print reports, and display all programmed
parameter values.

4.13.2.1 Considerations for retrieving device data from a diskette

Warning: The Read From Disk application is designed only for viewing saved data while no

patient session is in progress. You cannot program a device or deliver Emergency therapies
from the Read From Disk application.

Device testing – You cannot perform tests on the device when reading data from a diskette.

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4.13.2.2 How to read device data from a diskette

1. Insert a diskette that contains information saved during a patient session.

2. From the Select Model screen, select the product category from the View list.

3. Select the Read From Disk version of the device.

4. Select [Start].

5. Select [OK] after reading the warning message that informs you that programming a
device and emergency operations are not possible while you are in the Read From Disk
application.

6. Select [Open File…].

7. Select the data record that displays the desired device serial number, date, and time.

8. Select [Open File]. The Read From Disk screen displays information from the saved
session.

4.14 Using SessionSync to transfer device data to the Paceart system

The SessionSync feature enables you to transfer device data through your clinic network
between the Medtronic CareLink Model 2090 Programmer and the Medtronic Paceart data
management system, if Paceart is available in your locale. Transferred device data can be
stored and used for later analysis and patient management.

The SessionSync status icon indicates network connectivity and shows data transfer when
the SessionSync feature is enabled. The SessionSync Status screen provides information
about the connection status of the programmer to the data management system. Details
about the SessionSync status icon and connection status are provided in Section 4.14.4.2,
States of the SessionSync status icon, page 95.

Notes:

• For information about searching, viewing, and printing data from the patient records
stored on the Medtronic Paceart data management system, consult the Paceart
documentation.

• For information about saving data to disk, and retrieving, viewing, and printing data from
the diskette, see Section 4.13, Saving and retrieving device data, page 88.

• The SessionSync feature operates within the context of a patient session. See
Section 4.2, Conducting a patient session, page 48 for information about starting and
ending a patient session and interrogating a device.

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4.14.1 Enabling and disabling the SessionSync feature

Typically, the SessionSync feature is enabled only once, when it is first installed. Once the
SessionSync feature is enabled, any device application on the programmer that can use the
SessionSync feature has SessionSync functionality.

The SessionSync status icon indicates network connectivity and shows data transfer when
SessionSync is enabled. The SessionSync status icon is grayed out when the feature is
disabled, for example during a patient session.

4.14.1.1 How to enable and disable the SessionSync feature

1. From the Desktop, select Programmer > Preferences.

2. Select SessionSync from the index menu.

3. Select Enabled to enable the SessionSync feature, or select Disabled to disable the
SessionSync feature.

4.14.2 Configuring the SessionSync network connection

You must configure the programmer network settings to allow for data transfer.

4.14.2.1 Preparing to configure the SessionSync network connection

Physical connection – See the Medtronic programmer reference guide for instructions

describing how to connect an Ethernet cable from the programmer to your clinic’s network.

Gateway address – Prior to configuring the network connection, you will need to know your
SessionSync Gateway address. If you do not have your SessionSync Gateway address,
contact your clinic’s technical support or Medtronic Paceart technical support at
1-800-PACEART.

4.14.2.2 How to configure the SessionSync network connection

1. From the Desktop, select Programmer > SessionSync Network Configuration….

2. Enter the Clinic Name.

3. Enter the IP address or hostname of the SessionSync Gateway.

4. Select [OK].

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4.14.3 Transferring device data

Device data is transferred to the Medtronic Paceart data management system using either
Automatic SessionSync or Manual SessionSync.

4.14.3.1 Transferring session data with Automatic SessionSync

Perform the following steps to end the current session and use Automatic SessionSync to
transfer session data between the Medtronic CareLink Model 2090 Programmer and the
Medtronic Paceart data management system.

1. Select [End Session…].

The End Session window is displayed.

Figure 18. End Session window

1 Automatic SessionSync check box

2. Make sure that the Automatic SessionSync check box is selected.

Notes:

• The Automatic SessionSync check box is not visible in the End Session window if
device interrogation is not successful.

• The Automatic SessionSync check box is not visible in the End Session window if
SessionSync is not enabled on the programmer.

3. Select [End Now].

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The following actions occur:

a. Data transfer begins immediately.

b. The SessionSync – Saving Session Data on Programmer window is displayed to

show the progress of the data transfer.

c. The programmer side of the SessionSync status icon turns blue after the data has

been saved on the programmer’s hard disk.

d. If the subsequent transfer is successful, the data management system side of the

SessionSync status icon turns blue.

See Section 4.14.4, Viewing the SessionSync data transfer status, page 94, for more
details about status icon indications.

Note: If error messages appear during the data transfer process, see Section 4.14.5,
SessionSync error messages for a list of message descriptions.

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4.14.3.2 Transferring session data with Manual SessionSync

You can use Manual SessionSync at any time during a patient session to transfer session
data between the Medtronic CareLink Model 2090 Programmer and the Medtronic Paceart
data management system.

To use Manual SessionSync, select Session > SessionSync…. The following events occur
during the data transfer process:

1. The SessionSync – Saving Session Data on Programmer window opens to show the
progress of session data being saved automatically on the programmer’s hard disk.

2. The programmer side of the SessionSync status icon turns blue after the data has been
saved on the programmer’s hard disk.

3. If the subsequent transfer is successful, the data management system side of the
SessionSync status icon turns blue.

See Section 4.14.4.2, States of the SessionSync status icon, page 95 for more
details.

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Notes:

• SessionSync may have been disabled outside the patient session. If so, SessionSync…
is not listed in the Session menu and the SessionSync status icon is unavailable.

• The procedure in Section 4.14.3.1, Transferring session data with Automatic
SessionSync, page 92 allows you to transfer session data automatically, but it requires
that you end the current session to do so.

• If error messages appear during the data transfer process, see Section 4.14.5,
SessionSync error messages, page 96 for a list of message descriptions.

4.14.3.3 Transferred data

The following table lists the device data that is transferred with Automatic SessionSync or
Manual SessionSync to the Medtronic Paceart data management system.

Table 6. Data transferred with SessionSync

Feature name Information exported

Therapy Parameters Initial interrogated values

Last programmed values

Patient Information Last programmed values

Battery and Lead Measurements Last measured values

Threshold Tests

Sensing Tests

Automatic Diagnostics Event Counters

Device Memory Retrieved from interrogation performed only for saving session

a

Manual test results are saved only if the user has saved the results.

a

a

Last results for each test type conducted (for each chamber
tested)

Last results for each test type conducted (for each chamber
tested)

Ventricular Arrhythmia Episodes

data

4.14.4 Viewing the SessionSync data transfer status

The programmer indicates the status of the SessionSync feature through the SessionSync
status icon in the task bar and through the SessionSync Status screen.

When all components of the SessionSync status icon are grayed out in the task bar, it means
that the SessionSync feature has been disabled under the programmer preferences. No
data transfer can occur in this state.

The SessionSync status does not dynamically update when the SessionSync Status
window is open. To update the status, select the [Update Status] button.

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4.14.4.1 How to view the status of the SessionSync feature from the programmer task bar

The programmer task bar displays a SessionSync status icon that indicates the current data
transfer activity and the status of the communication link between the programmer and data
management system. If the SessionSync feature is not installed on the programmer, the icon
will not be visible in the task bar.

Figure 19. SessionSync status icon on the programmer task bar

Figure 20. SessionSync status icon indicators

1 Data management system status
2 Connection status

3 Programmer status

4.14.4.2 States of the SessionSync status icon

The following table lists the states of the SessionSync status icon that appears in the
programmer task bar.

Table 7. SessionSync status icon states

Part of SessionSync sta­tus icon

Data management system
status

Connection status Not visible No valid connection between the programmer

Programmer status Gray No session data files in the Transfer Queue

Color What the color indicates

Gray No session data has been transferred to the

data management system

Blue All session data has been successfully trans-

ferred to the data management system

and the data management system

Green Valid connection between the programmer

and the data management system

Red circle with a line
through it

Blue Session data files in the Transfer Queue

A device application in use that does not sup­port SessionSync

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4.14.4.3 How to view the status of the SessionSync feature from the SessionSync Status screen

The SessionSync Status screen displays information about the data files being transferred
to the data management system using the SessionSync feature. Each status message
includes the date, time, and event information for the associated SessionSync event.

1. From the Desktop, select Programmer > SessionSync Status.

2. Select the [Update Status] button.

Note: Events displayed on the SessionSync Status screen are not automatically updated
when SessionSync Status is selected from the menu. The user must manually select the
[Update Status] button to refresh the events that are displayed.

4.14.5 SessionSync error messages

Table 8. SessionSync error messages

Error Message What this means

Ending a Session without Automatic
SessionSync

Interrogation Required You must conduct an interrogation.

Data Transfer Failed The data cannot be transferred to the data manage-

Unable to Save Session Data The session data cannot be saved on the programm-

You have deselected the Automatic SessionSync
check box on the End Session window before select­ing the [End Now] button.

ment system. The session data has been successfully
saved on the programmer’s hard disk but cannot be
transferred to the data management system.
Select [Retry] to retry the SessionSync operation.

- or ­Select [Cancel] to close the window.

er’s hard disk.
Select [Save to Disk…] to save the session data on a
floppy disk.

- or ­Select [End Now] to end the session without saving
the device data.

- or ­Select [Cancel] to close the window without saving the
device data.

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4.15 Printing reports

The programmer provides flexibility in printing reports that are available from the system. You
can print informative standard reports, and you can access print functions in a variety of
ways. You can also specify when to print a particular report and which printer to use.

4.15.1 Setting preferences for printing, reports, and tests

Preferences allow you to select print options, such as number of copies, printer type, and
whether to print now or later. They also allow you to select report options for printing reports
at the beginning, during, or at the end of a patient session.

• Printing preferences are applied automatically whenever you select the [Print…] button.
If you prefer to set print preferences each time you print a report, select the check box
next to “Pop up these options when any Print button is selected”. When you select this
check box, a Print Options window appears each time that you select the [Print…]
button.

For more information about setting up an external full-size printer, see the user guide for
your Medtronic programmer.

• Report preferences are applied variously, depending on which report is being produced.
These are described in the several procedures found in the following sections.

• Tests preferences control how waveform traces are arranged in the live rhythm display.

4.15.1.1 How to set printing preferences

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1. After starting a patient session, select Reports > Preferences….

2. From the Index selection box, select the Printing option.

3. Select your printing preferences as desired.

4. Select [OK].

Basic printing preferences take effect immediately.

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4.15.1.2 How to set Initial Report preferences

1. After starting a patient session, select Reports > Preferences….

2. From the Index selection box, select the Initial Report option.

3. Select the check box next to “Print Initial Interrogation Report after first interrogation”, if
desired. The report prints automatically at the beginning of a patient session after the
device is interrogated.

4. Select the additional reports to include in the Initial Interrogation Report.

5. Select [OK].

6. To print an Initial Interrogation Report for a patient session that is in progress, end and
restart the patient session. The Initial Interrogation Report prints automatically after
interrogation.

Initial Report preferences take effect at the start of a new session and remain in effect until
you change them and start a new session.

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4.15.1.3 How to set Final Report preferences

You can select the reports you want printed as a part of the Final Report. The Session
Summary Report always prints when a Final Report print request is made.

1. Before ending a patient session, select Reports > Preferences….

2. From the Index selection box, select the Final Report option.

3. The Session Summary check box is selected and cannot be unselected. This ensures
that at least one report prints when a Final Report print request is made.

4. If this is the first time you are establishing Final Report preferences, the Parameters – All
Settings selection should be selected.

5. Select the additional reports to include in the Final Report.

6. Select [OK].

Note: The selections you make using the Final Report Preferences feature persist between
sessions and across all applications.

To print the selections you made using the Final Report Preferences feature, follow the steps
in Section 4.15.4.1.

4.15.1.4 How to set Tests preferences

The Tests preferences in the Index selection box allows you to choose how waveform traces
are displayed during a selected follow-up test. You can choose to make the live rhythm
display arrange the waveforms to show the EGM of the heart chamber being tested, or to
keep the waveform arrangement unchanged.

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1. Select Reports > Preferences….

2. From the Index selection box, select the Tests option.

3. Choose the desired option (“Auto-arrange waveforms” or “Do not auto-arrange
waveforms”).

4. Select [OK].

For more information on tests, see Chapter 10, Testing the system, page 310.

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4.15.2 Printing an Initial Interrogation Report

The programmer automatically prints certain reports after the first interrogation in a patient
session if you set Initial Report preferences to do so. The reports that print automatically after
the first interrogation in a patient session are collectively called the Initial Interrogation
Report. The Quick Look II Report is always a part of the Initial Interrogation Report. You can
also select other reports to print as part of the Initial Interrogation Report.

For more information, see Section 4.15.1.2.

4.15.3 Printing reports during a patient session

The programmer allows you to specify a particular set of reports for printing and to print a
report based on the screen you are viewing.

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