Medtronic DDMD3D1 Reference Guide

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PRIMO MRI™/MIRRO MRI™ SURESCAN™

Family of MR Conditional digital implantable cardioverter defibrillators with SureScan™ Technology

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

PRIMO MRI™/MIRRO MRI™ SURESCAN™

Reference Manual

A reference manual for the Medtronic Primo MRI/Mirro MRI SureScan family of digital implantable cardioverter defibrillators.

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, Cardiac Compass, CareAlert, CareLink, ChargeSaver, Conexus, Export, Flashback, Integrity, Intrinsic, Marker Channel, Marquis, Medtronic, Medtronic CareAlert, Medtronic CareLink, Mirro MRI, MVP, Paceart, PR Logic, Primo MRI, Quick Look, Reactive ATP, SessionSync, SureScan, Switchback, T-Shock, TherapyGuide

Medtronic

PRIMO MRI™/MIRRO MRI™ SURESCAN™

Contents

1 Introduction .......................................................... 8

1.1 Introduction ......................................................... 8

1.2 Primo MRI/Mirro MRI SureScan ICD feature model matrix ................ 10

2 Conducting a patient session with the programmer .................... 11

2.1 Establishing telemetry between the device and the programmer ........... 11

2.2 Starting and ending a patient session ................................. 16

2.3 Display screen features .............................................. 20

2.4 Delivering an emergency tachyarrhythmia therapy ....................... 25

2.5 Enabling emergency VVI pacing ...................................... 27

2.6 Suspending and resuming tachyarrhythmia detection .................... 28

2.7 Monitoring cardiac activity with the Live Rhythm Monitor .................. 30

2.8 Navigating a patient session with Checklist ............................. 39

2.9 Programming device parameters ...................................... 41

2.10 Saving and retrieving a set of parameter values ......................... 42

2.11 Using TherapyGuide to select parameter values ......................... 44

2.12 Storing patient information ........................................... 47

2.13 Printing reports ..................................................... 51

2.14 Transferring data to Paceart with SessionSync .......................... 53

2.15 Saving and retrieving device data ..................................... 60

2.16 Patient follow-up guidelines ........................................... 63

2.17 Optimizing device longevity ........................................... 67

3 Diagnostic data features ............................................. 70

3.1 Quick Look II summary data .......................................... 70

3.2 Medtronic CareAlert events and notifications ............................ 74

3.3 RV Lead Integrity Alert ............................................... 83

3.4 Device and lead performance data .................................... 89

3.5 Cardiac Compass Trends ............................................ 96

3.6 Arrhythmia Episodes data ........................................... 101

3.7 Episode and therapy counters ....................................... 111

3.8 Flashback Memory data ............................................ 116

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3.9 Rate Drop Response episodes ....................................... 117

3.10 Rate Histograms ................................................... 120

3.11 Automatic device status monitoring ................................... 122

4 Pacing features ..................................................... 126

4.1 Sensing .......................................................... 126

4.2 Basic pacing ...................................................... 136

4.3 Managed Ventricular Pacing (MVP) ................................... 145

4.4 Rate Response .................................................... 152

4.5 Rate Adaptive AV .................................................. 160

4.6 Auto PVARP ...................................................... 162

4.7 Rate Drop Response ............................................... 164

4.8 Rate Hysteresis .................................................... 170

4.9 Sleep feature ...................................................... 172

4.10 Non-Competitive Atrial Pacing ....................................... 173

4.11 PMT Intervention .................................................. 175

4.12 PVC Response .................................................... 176

4.13 Ventricular Safety Pacing ............................................ 178

4.14 Mode Switch ...................................................... 180

4.15 Conducted AF Response ........................................... 183

4.16 Atrial Rate Stabilization ............................................. 185

4.17 Atrial Preference Pacing ............................................ 188

4.18 Post-Mode Switch Overdrive Pacing .................................. 192

4.19 Post Shock Pacing ................................................. 195

4.20 Post VT/VF Shock Overdrive Pacing .................................. 196

4.21 Ventricular Rate Stabilization ........................................ 197

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5 Tachyarrhythmia detection features .................................. 200

5.1 AT/AF detection ................................................... 200

5.2 VT/VF detection ................................................... 206

5.3 PR Logic .......................................................... 221

5.4 Wavelet .......................................................... 225

5.5 Onset ............................................................ 232

5.6 Stability ........................................................... 238

5.7 High Rate Timeout ................................................. 240

5.8 TWave Discrimination .............................................. 242

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5.9 RV Lead Noise Discrimination ....................................... 246

6 Tachyarrhythmia therapy features ................................... 251

6.1 Atrial therapy scheduling ............................................ 251

6.2 Atrial ATP therapies ................................................ 258

6.3 Atrial cardioversion ................................................. 268

6.4 Patient-activated atrial cardioversion .................................. 274

6.5 VF therapies ...................................................... 279

6.6 Ventricular ATP therapies ........................................... 289

6.7 Ventricular cardioversion ............................................ 299

6.8 Progressive Episode Therapies ...................................... 308

7 System test and EP Study features .................................. 310

7.1 Underlying Rhythm Test ............................................. 310

7.2 Pacing Threshold Test .............................................. 311

7.3 Wavelet Test ...................................................... 313

7.4 Lead Impedance Test ............................................... 316

7.5 Sensing Test ...................................................... 317

7.6 Charge/Dump Test ................................................. 319

7.7 Arrhythmia inductions with EP Studies ................................ 320

7.8 Manual therapies with EP Studies .................................... 328

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Glossary ................................................................ 331

Index ................................................................... 341

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1 Introduction

1.1 Introduction

This manual describes the operation and intended use of features offered by Medtronic Primo MRI/Mirro MRI SureScan ICD devices.

The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely scanned by an MRI machine while the device continues to provide appropriate pacing. When programmed to On, MRI SureScan operation disables arrhythmia detection and all user-defined diagnostics. Before performing an MRI scan, refer to the MRI technical manual.

Throughout this manual, the word “device” refers to the implanted ICD device.

The programmer screen image examples in this manual are provided for reference only and may not match the final software.

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

Tables in the feature programming sections summarize how to navigate to screens with programmable parameters for the feature. As shown in the example in Table 1, each table row lists a parameter or group of parameters with the path to a specific screen on the programmer. If the navigation path is the same for related parameters, the path is not repeated in the table. Additional rows are included for parameters that appear on different screens. Groups of parameters, such as “ATP parameters”, include the word “parameters”. Individual parameters, such as “Energy” and “Pathway”, do not.

Table 1. How to navigate to VF therapies parameters

Parameters Path

VF therapies (Rx1 through Rx6) VF Therapy Status (On, Off) Energy Pathway

ATP parameters (Rx1) Params > VF Therapies… > ATP…

ChargeSaver parameters (ATP in Rx1) Params > VF Therapies… > ATP… > During

Shared Settings (V. ATP and V. Therapies) Params > VF Therapies… > Shared Settings…

The feature programming sections also include programming considerations. For detailed information about parameter settings, see the device manual for the specific device.

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Params > VF Therapies…

Charging > ChargeSaver…

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1.1.1 Product literature

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

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

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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 give them any patient information materials packaged with the device.

The following manuals and documents also contain information about the device:

MRI technical manual – This manual provides MRI-specific procedures and warnings and precautions.

Device manual – Each device model has a separate device manual. The manual contains the specific features for the model, indications and contraindications, warnings and precautions, instructions for implanting the device, quick reference specifications, and parameter tables.

Explanation of symbols – This document defines the symbols that may appear on the device package. Refer to the package label to see which symbols apply specifically to this device.

Radio regulatory compliance insert – This document provides Federal Communications Commission (FCC) regulations and compliance information for the transmitter in this active implantable medical device.

Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals – This manual provides warnings, precautions, and guidance for health care

professionals who perform medical therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments.

1.1.2 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 telephone number or address listed on the back cover.

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1.1.3 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 THAT RESULT FROM THE USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE SOFTWARE.

For more information, see Section 2.12, “Storing patient information”, page 47.

1.2 Primo MRI/Mirro MRI SureScan ICD feature model matrix

Feature availability for each device model is marked with an “X” in the corresponding column.

Table 2. Product feature relationship

Primo MRI SureScan Mirro MRI SureScan

DDMD3D4 DDMD3D1 DVMD3D4

Features

Conducted AF Response X

Rate Drop Response X

Atrial Rate Stabilization X

Atrial Preference Pacing X

Post Mode Switch Overdrive Pacing X

Wavelet X

High Rate Timeout X

TWave Discrimination X

RV Lead Noise Discrimination X

Confirmation+ X

Atrial therapy scheduling X

Atrial antitachycardia pacing X

Atrial cardioversion X

Wavelet Test X

DVMD3D1

DDME3D4 DDME3D1 DVME3D4 DVME3D1

Note: All other features described in this manual apply to all Primo MRI/Mirro MRI SureScan

ICD devices.

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2 Conducting a patient session with the programmer

2.1 Establishing telemetry between the device and the programmer

You can conduct a patient session using wireless or nonwireless telemetry.

You cannot switch between wireless and nonwireless telemetry during a patient session. If you are conducting a patient session and you wish to change the telemetry mode, you must end that session and start a new session using the alternative mode.

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

2.1.1 Using Conexus wireless telemetry

To establish wireless telemetry, use the Medtronic programmer with Conexus telemetry or the Medtronic Conexus Activator. The Conexus Activator is a hand-held, battery-powered communication device. It enables wireless telemetry in a Conexus-compatible heart device independently of a programmer. Once wireless telemetry is established, a practitioner can use the programmer to conduct a session without using the programming head.

Conexus wireless telemetry uses the Medical Implant Communications Service (MICS) radiofrequency band, which is designated worldwide for medical devices. Using this band protects devices against interference from home electronics, such as microwaves, cell phones, and baby monitors.

Conexus wireless telemetry is designed for use during implant and follow-up sessions.

At implant, Conexus wireless telemetry enables you to:

●

interrogate the patient’s wireless device without using a programming head (no programming head in the sterile field)

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maintain connectivity during induction and delivery of therapies

●

program the device anytime during the procedure while maintaining continuous patient monitoring

During follow-up sessions, Conexus wireless telemetry maintains continuous communication between the device and the programmer.

Medical Implant Communications Service (MICS) is also referred to as the core 402-405 MHz band of the Medical Device Radiocommunication Service (MedRadio).

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During remote follow-up sessions with the CareLink Network, Conexus wireless telemetry automatically transmits comprehensive arrhythmia and diagnostic device data. It transmits wirelessly without patient involvement.

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2.1.1.1 How to activate wireless telemetry

1. Turn on the programmer.

Make sure the “Allow wireless communication” check box in the Find Patient window is selected.

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

When wireless telemetry is first established during a session, the telemetry status indicator in the upper left corner of the task bar changes from the programming head icon to the wireless telemetry icon, as shown in Figure 1 .

Figure 1. Wireless telemetry icon on the task bar

1 Wireless telemetry icon

The indicator bar on the icon displays the strength of the wireless signal. At least 3 of the green lights must be illuminated to ensure reliable telemetry has been established.

If you are using the Conexus Activator, press the blue button to activate wireless telemetry. A green light illuminates when you have successfully communicated with the device.

2.1.1.2 Conexus wireless timer operation

Once you initiate wireless telemetry, the device sends a signal to the programmer and remains active for a period of time. A response from the programmer establishes communication, and the device appears in the Find Patient window when that window is open. If the programmer touch pen is not used within 5 min, the Find Patient window closes and the Select Model screen appears.

When you end a session, you have a short period of time where you can re-interrogate the device before the session ends completely.

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The inactivity timer is 2 hours for the first week after implant, at which time it changes to 5 min automatically. If the Extend Wireless Telemetry Session feature is available, you have the option to extend the inactivity timer from 5 min to 2 hours in any patient session. When the session is ended, the timer reverts to 5 min. This feature reduces device battery depletion.

If electrical interference disrupts a session, the programmer attempts to re-establish communication with the device. If you are unable to re-establish communication between the device and the programmer, use the Conexus Activator or programming head to reactivate wireless telemetry in the device to resume or start a session.

2.1.1.3 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 other electrical equipment is in the area, the system is designed to maintain effective communication between the device and the programmer at distances up to 2 m (6.5 feet). The system should not interfere with other electronic equipment in the area.

If you are having trouble maintaining consistent, reliable telemetry, take one or more of the following actions:

●

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

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Change the position of the programmer so that the space between the programmer screen and the patient is relatively free of obstruction. Make sure that nothing is between the programmer and the patient.

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Shorten the distance between the programmer and the patient.

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

2.1.1.4 Session inactivity safeguards

If you or the patient moves away from the programmer, the system guards against unintentional programming in the following ways:

●

After 2 min of programmer inactivity, the system displays the patient’s name or ID number, if available, and device information. You are then required to confirm that the correct patient is in the follow-up session before you can process a programming command.

●

After 2 hours of programmer inactivity in an implant session or a follow-up session, the device transitions to Standby mode.

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Standby mode – Use Standby mode when you need a period of inactivity in a patient session. In this mode, live waveforms are turned off, and the programmer telemetry status indicator shows no telemetry link. Programmer functions are limited.

You can activate and deactivate Standby mode in the device manually:

●

To activate Standby mode, select the wireless telemetry icon on the task bar.

●

To deactivate Standby mode and reactivate wireless telemetry with the programmer, select the wireless telemetry icon on the task bar 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. To recover the wireless telemetry session, use either the Conexus Activator or the programming head.

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. To deactivate Standby mode and resume a patient session, verify that the session is with the intended patient, select the “Allow communication with” check box, and select [Continue].

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

2.1.1.5 Device standby mode

When the device is in standby mode, live waveforms are turned off, the programmer telemetry status indicator shows no telemetry link, and programmer functions are limited. You can use standby mode when you need a period of inactivity in a patient session.

To activate and deactivate Standby mode in the device manually:

●

To activate Standby mode, select the wireless telemetry icon on the task bar.

●

After a brief period of time in Standby mode, wireless telemetry is deactivated within the device. To recover the wireless telemetry session, use either the Conexus Activator or the programming head.

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

2.1.1.6 Managing wireless telemetry session duration

Reducing wireless telemetry session duration may help reduce the energy requirements placed on the battery.

●

At implant and in the first 7 days after implant, the wireless telemetry session duration is 2 hours to provide time for implant, programming, and patient follow-up tasks. The device transitions to Standby mode after 2 hours of programmer inactivity.

●

7 days after implant, the wireless telemetry session duration is reduced automatically to 5 min to help preserve device longevity. The device transitions to Standby mode after 5 min of programmer inactivity. If patient follow-up tasks require it and if the Extend Wireless Telemetry Session feature is available, you can optionally extend the wireless telemetry for a patient session to 2 hours by selecting Session > Extend Wireless Telemetry Session and then selecting [Continue]. At the end of the session, the wireless telemetry session duration for the patient reverts automatically to 5 min.

2.1.1.7 How to maintain patient safety and privacy

During a wireless telemetry session, all other programmers are blocked from communicating or initiating a session with the patient’s implanted device. 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. If you have not entered the patient’s name, the patient’s ID number appears. If the patient’s name or ID has not been entered, then “Patient name is 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.

2.1.2 Using nonwireless telemetry

Some Medtronic programmers feature only nonwireless telemetry. If your Medtronic programmer features both Conexus wireless telemetry and nonwireless telemetry, you must choose to use nonwireless telemetry.

Note: You must have a Medtronic programming head to use nonwireless telemetry.

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2.1.2.1 How to establish nonwireless telemetry

1. Turn on the programmer.

If you are using a programmer with Conexus wireless telemetry, make sure the “Allow wireless communication” check box in the Find Patient window is not selected. The check box does not appear if you are using a programmer without Conexus wireless telemetry.

2. Place the programming head over the device to activate nonwireless telemetry in the device.

When nonwireless telemetry is established during a session, the telemetry status indicator on the task bar displays the programming head icon, as shown in Figure 2.

Figure 2. Programming head icon on the task bar

1 Programming head icon

Note: The magnet in the programming head can suspend tachyarrhythmia detection. However, when telemetry between the device and the programmer is established, detection is not suspended.

When 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. To ensure that the proper telemetry is established, position the programming head over the device so at least 2 of the green lights illuminate. 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.

2.2 Starting and ending 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, start a new session for each patient. End the previous session before starting a session with another patient.

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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.

2.2.1 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. If tachyarrhythmia detection is programmed on, 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].

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2.2.2 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 programmer with Conexus wireless 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 programmer without Conexus wireless 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.

2.2.3 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 interference could result in a temporary loss of telemetry indicator lights as shown on the programmer task bar and a temporary loss in Marker transmissions. It could also 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 before any manual or automatic capacitor charging.

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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 wireless telemetry session. To use Holter telemetry during a Conexus wireless 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 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.

PRIMO MRI™/MIRRO MRI™ SURESCAN™

2.2.4 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 can 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. 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 programmer operation. You must select [Exit Emergency] before you can manually interrogate the device.

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2.2.5 How to end a patient session

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

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

3. Select [End Session…].

4. To save the session data to a USB flash drive or a disk, if available, select [Save To Media…].

5. To end the session and return to the Select Model screen, select [End Session…] and then [End Now].

2.3 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 3.

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Figure 3. Main elements of a display screen

PRIMO MRI™/MIRRO MRI™ SURESCAN™

1 Task bar 2 Status bar 3 Live Rhythm Monitor window

4 Task area 5 Command bar 6 Tool palette

2.3.1 Task bar

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

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 4. Task bar display

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1 Telemetry icon and telemetry strength

indicator (wireless telemetry shown) 2 SessionSync icon 3 Disk icon (for some Medtronic programmer

models)

4 USB icon 5 Analyzer icon 6 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 2.14, “Transferring data to Paceart with SessionSync”, page 53.

2.3.2 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 5. 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

2.3.3 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 window shows the following information:

●

The heart rate and the rate interval appear if telemetry has been established with the device.

●

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

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The Live Rhythm Monitor window appears in the partial view by default. 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, see Section 2.7, “Monitoring cardiac activity with the Live Rhythm Monitor”, page 30.

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2.3.4 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 2.9, “Programming device parameters”, page 41.

Figure 6. Task area of the screen

2.3.5 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 3.

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Table 3. 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.

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.

PRIMO MRI™/MIRRO MRI™ SURESCAN™

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.

2.3.6 Buttons

Buttons, such as those shown in Figure 7, respond when you “select” them by touching them with the tip of the touch pen.

Figure 7. Display screen buttons

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

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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.

2.3.7 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.

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 8. Command bar

2.4 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.

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2.4.1 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 re-enable 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].

Emergency tachyarrhythmia therapies and MRI SureScan – If you deliver any emergency tachyarrhythmia therapy when MRI SureScan is programmed to On, MRI SureScan is automatically programmed to Off.

2.4.2 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.

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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.

2.5 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.

Note: If you enable emergency VVI pacing when MRI SureScan is programmed to On, MRI SureScan is automatically programmed to Off.

2.5.1 Considerations for emergency VVI pacing

Parameter values – Emergency VVI pacing reprograms pacing parameters to emergency

settings. For a list of the emergency VVI parameter settings, see the device manual for the device. To terminate emergency VVI pacing, you must reprogram pacing parameters from the Parameters screen.

2.5.2 How to enable emergency VVI pacing

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

2. Press the red VVI button on the programmer to enable emergency VVI pacing.

Depending on your model of Medtronic programmer, the emergency VVI button is:

●

a mechanical red button to the left of the programmer screen, on the programmer bezel.

●

a red button on the programmer button panel, above the programmer screen.

Note: On all programmers, an [Emergency] button is implemented in the software and is available on the display screen (see the following procedure for instructions regarding this button).

How to enable emergency VVI pacing with the on-screen [Emergency] button –

Perform the following steps to enable emergency VVI pacing with the on-screen [Emergency] button:

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1. Establish telemetry with the device.

2. Select [Emergency].

3. Select VVI Pacing.

4. Select [PROGRAM].

PRIMO MRI™/MIRRO MRI™ SURESCAN™

2.6 Suspending and resuming tachyarrhythmia detection

It may be necessary to turn off tachyarrhythmia detection in some situations. For example, during emergency therapies and some EP study tests, therapies are delivered manually, and detection and episode storage are not needed. Also, certain types of surgery, including electrocautery surgery, RF ablation, and lithotripsy, can cause the device to detect tachyarrhythmias inappropriately and possibly deliver inappropriate therapy.

When detection is suspended, the device temporarily stops the process of classifying intervals for tachyarrhythmia detection. Sensing and bradycardia pacing remain active, and the programmed detection settings are not modified. When the device resumes detection, it does so at the previously programmed detection settings. The Suspend/Resume function applies to both atrial and ventricular tachyarrhythmia detection.

Note: If MRI SureScan is programmed to On, tachyarrhythmia detection and Medtronic CareAlert events (including audible alerts) are suspended.

2.6.1 Considerations for suspending detection

If you suspend detection during a tachyarrhythmia detection process but before detection has occurred, the initial detection never occurs. When you resume, detection starts over.

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If you suspend detection after a tachyarrhythmia detection has occurred and resume detection before the tachyarrhythmia episode terminates, redetection works differently for each type of episode, as follows:

AT/AF episodes – If you suspend detection during a detected AT/AF episode and then resume detection before the episode terminates, detection starts over for the same episode.

Note: Suspending tachyarrhythmia detection does not affect Mode Switch. A Mode Switch may occur whether or not tachyarrhythmia detection has been suspended.

VT/FVT/VF episodes – If you suspend detection while a therapy is being delivered, the device finishes delivering the therapy that is in progress but does not redetect until you resume detection. If you resume detection before the episode terminates, the device begins redetection, and the episode is redetected if the programmed Beats to Redetect value is reached.

VT Monitor episodes – If you suspend detection during a detected VT Monitor episode, and then resume detection before the episode terminates, there will be episode data storage for 2 episodes with the first episode terminated while the rate is still fast.

PRIMO MRI™/MIRRO MRI™ SURESCAN™

2.6.2 How to suspend or resume detection with the programmer

Figure 9. [Suspend] and [Resume] buttons

The [Suspend] and [Resume] buttons can be used whenever there is telemetry with the device and the device software is running.

1. To suspend detection, select [Suspend]. The programmer displays a SUSPENDED annotation on the status bar.

2. To resume detection, select [Resume].

2.6.3 How to suspend or resume detection with a magnet

1. To suspend detection, place the magnet (such as the Model 9466 Tachy Patient Magnet) over the device.

2. To resume detection, remove the magnet from over the device.

Note: The programming head contains a magnet. When the programmer is using wireless telemetry, you can suspend detection by placing the programming head over the device. For more information, see Section 2.1, “Establishing telemetry between the device and the programmer”, page 11.

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2.7 Monitoring cardiac activity 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 to the programmer’s strip chart recorder or Electronic Strip Chart (eStrip) recorder, whichever is available, and recall any saved waveform strips prior to ending a patient session.

By default, the Live Rhythm Monitor window 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.

2.7.1 Types of live waveform traces

2.7.1.1 Leadless ECG (LECG) waveform

Leadless ECG simplifies and expedites 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.

Leadless ECG provides a far-field view of cardiac activity without connecting leads to the patient. 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. You can also choose to display the waveform from the RVcoil to Aring source or the Can to Aring source on the LECG channel. This signal is telemetered from the device and is selected from the programmable LECG source when you set up data collection.

2.7.1.2 ECG waveforms

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.

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2.7.1.3 EGM waveforms

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 device has been interrogated.

You can also choose the sources of the LECG waveforms when you set up data collection. For more information, see Section 3.6, “Arrhythmia Episodes data”, page 101. Data collection parameters are provided in the device manual.

2.7.2 Viewing live waveform traces

2.7.2.1 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, if available. You can select up to 2 waveform traces for printing.

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2.7.2.2 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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7. Select the calibrate button to add a reference signal to the analog output, the screen, and the real-time strip recorder or Electronic Strip Chart (eStrip) recorder, whichever is available.

8. When you finish making adjustments, select [OK].

PRIMO MRI™/MIRRO MRI™ SURESCAN™

2.7.2.3 How to interpret Marker Channel annotations and symbols

Marker Channel annotations appear as 2 characters above or below the Marker Channel waveform trace. 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, if available.

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.

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A S

A R

A b

A P

V S

V P

E R

V R

M S

P P

Atrial pace

Atrial sense

Atrial refractory

sense

Atrial sense in

PVAB

Ventricular pace

Ventricular

sense

Ventricular

refractory sense

Ventricular

safety pace

Mode switch

Marker buffer full

Proactive pace

Medtronic PRIMO MRI™/MIRRO MRI™ SURESCAN™

Figure 10. Pacing Marker Channel annotations and symbols

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F S

T S

T P

A P

C D

F D

T D

C E

AT/AF sense

Atrial tachy

pace

Fast AT/AF

sense

AT/AF

detection

Fast AT/AF

detection

Cardioversion

pulse

Charge end

Atrial 50 Hz

burst

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 sense

VT detection FVT detection VF detection VT monitor

detection

Ventricular

tachy pace

50 Hz Burst

induction

Charge end

Cardioversion/

defibrillation

pulse

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Figure 11. Atrial detection and therapies Marker Channel annotations and symbols

Figure 12. Ventricular detection and therapies Marker Channel annotations and symbols

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2.7.3 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 EGM in either of two ways:

1. on an internal strip chart recorder, if available on your Medtronic programmer.

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.

2. on an Electronic Strip Chart (eStrip) recorder, if available on your Medtronic programmer.

A printout or recording 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

●

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. For more information, see Section 3.6, “Arrhythmia Episodes data”, page 101.

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, if available with your Medtronic programmer. Printing to an external 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.

Programmers that feature a strip chart recorder cannot display or record an EGM or LECG trace until the device has been interrogated.

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2.7.4 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.

Figure 13. 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.

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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.

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2.7.5 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.

2.7.5.1 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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2.8 Navigating a patient session with Checklist

Use the Checklist feature to cycle through common tasks that are performed during an implant session or a follow-up session. When you select a task, the associated programmer screen for that task appears. Once you complete a task, you can either go back to the Checklist or continue on to the screen associated with the next task. You can use the standard checklists created by Medtronic, or you can create customized checklists that reflect your personal workflow.

2.8.1 How to use a standard checklist

1. Select the Checklist icon on the right side of the programmer screen. Two standard checklists are available: the Medtronic Standard Followup checklist and the Medtronic Standard Implant checklist.

2. Select the checklist you want from the Checklist field.

3. Select either the [>>] button next to the Checklist icon or the [Go To Task] button to start using the checklist.

4. Use the [>>] button to continue from one task to the next. Any time you want to return to the Task list, select the Checklist icon.

5. To repeat a task or perform a task out of order, select the task and use the [Go To Task] button or the [>>] button.

Once you have completed all the tasks on the Task list, [>>] and [Go To Task] become inactive. However, you can still select a task and use either button to complete the task. You can also use [>>] to advance through the tasks on the list.

Check marks appear next to the names of any programmer screens that were visited during a session.

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2.8.2 How to create and use a custom checklist

1. Select the Checklist icon.

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

3. Choose the tasks you want in your customized checklist from the box on the left.

4. The tasks you select appear in the box on the right. You can add the same task more than once. If you want a new task to appear somewhere else in the list rather than at the end, highlight the task that the new task should follow, and select the new task. The new task appears below the highlighted task.

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

6. To name your checklist, select the Checklist name field, and enter a name.

7. Select [Save].

To edit a custom checklist, select the checklist in the Checklist field and select [Edit…]. Add or delete tasks as needed. Then select [Save].

To rename a custom checklist, select the checklist in the Checklist field and select [Edit…]. Change the name and select [Save].

To delete a custom checklist, select the checklist from the Checklist field and select [Delete]. After a custom checklist has been deleted, it cannot be restored. The Medtronic Standard Followup checklist and the Medtronic Standard Implant checklist cannot be edited or deleted.

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2.9 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.

2.9.1 Understanding the symbols used on the Parameters screen

The following symbols can appear next to a parameter value.

Table 4. Symbols that appear with parameter values

Symbol Definition

This symbol indicates that the value is the Medtronic nominal value.

This symbol indicates that the value is the programmed value.

This symbol indicates that the programmed value can be changed automatically by the device. The adaptive symbol does not necessarily indicate that the parameter value has been adapted from a previously programmed value. It only indicates that it is able to be adapted.

This symbol indicates that the parameter value conflicts with the setting of another present or pending value. A parameter interlock exists.

This symbol indicates that a warning message is available about the value. A parameter warning exists.

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. If a parameter interlock symbol appears, select another value or resolve the conflicting parameter value before programming the parameter. If a parameter warning exists, select the message button to read the warning and view recommendations.

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The programmer may display a message button next to the [PROGRAM] button that accesses additional information about the pending parameters. When the message button is selected, the programmer opens a second window displaying one or more messages. The message button has one of the symbols described in Table 5.

Table 5. Symbols that appear on the message button

Symbol Explanation

Interlock – Indicates that a parameter interlock exists. Programming is

restricted until you resolve the conflict. Select this button for a message that describes the conflict.

Warning – 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.

Informational – Indicates that there is an informational message about 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.

2.9.2 How to program device parameters

1. Select a parameter field. If there are only 2 values, such as Off and On, the parameter field typically switches to the alternate value. If there are more than 2 values, a window opens showing available values for that parameter. If the parameter or parameter field contains an ellipsis (…), another screen appears, providing additional parameter selections.

2. Select the desired new value or values. The new values display as pending values. (You can also select [Close] to close the window without changing parameter values.)

3. If necessary, select [OK] to return to the Parameters screen.

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

2.10 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 flexibility 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.

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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.

2.10.1 How to save a set of parameter values

1. Select the Params icon.

2. Make the desired parameter selections.

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

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

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

2.10.2 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. Select [PROGRAM] to apply the pending values.

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.

To remove a parameter set from the list, choose the parameter set and select [Delete].

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2.11 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.

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.

2.11.1 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

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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 6. 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 clinical conditions do not influence a parameter, TherapyGuide may either recommend the Medtronic nominal value for that parameter or make no recommendation.

If the suggested value for a parameter is different from 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 6. How programming suggestions are determined

Programming suggestions Clinical conditions

VF Detection VT/VF

Slowest VT

VT Detection VT/VF

Slowest VT

VT Monitor Atrial Status

AV Conduction Date of Birth Treated Cutoff

Pacing Mode Atrial Status

AV Conduction

Lower Rate Atrial Status

Date of Birth

Upper Tracking Rate AV Conduction

Date of Birth

Treated Cutoff Rate Drop Response Atrial Status Rate Response

(including Upper Sensor Rate)

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

Atrial Status

Heart Failure

Date of Birth

Activity Level

2.11.2 Considerations for TherapyGuide

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

programmed into device memory from the Patient Information screen. For more information, see Section 2.12, “Storing patient information”, page 47.

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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 Media file.

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

2.11.3 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.

Notes:

●

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

●

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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2.11.4 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.

2.12 Storing patient information

You can use the Patient Information screen to enter patient-related information and program it into device memory. This information can then be viewed and printed during a patient session. Patient information is typically entered at the time of implant and 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 appears in the Patient Information screen.

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.

Some entries may appear shortened after they are entered. For example, the Patient field can display most but not all of the 29 characters that can be entered. The full entry is provided on the Patient Information Report. When displayed or printed from other screens, the text entry may be shortened.

For many fields, such as the Lead fields, you can either select an item from a list or use [Modify List] to enter an item that is not listed.

If you start a concurrent 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.

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2.12.1 How to view and enter patient information

1. Select Patient > Patient Information. The Patient Information screen appears.

2. Use the fields of the Patient Information screen to view or enter information for the patient.

3. Select [Program] on the Patient Information screen to program the entered patient information to the device.

The date of the last Patient Information update appears automatically.

Figure 15. Patient Information screen

Patient – Enter the patient’s name (29 character maximum).

ID – Enter the patient’s ID (15 character maximum).

Date of Birth – Enter the patient’s date of birth.

Serial Number – The serial number of the implanted device appears automatically.

Lead 1…, Lead 2… – Select these fields to access windows that let you enter and view the

following information for the implanted leads:

●

the model number of the lead

●

whether the lead is MR Conditional (Yes, No, or Unknown)

●

a lead position, such as RV

●

a lead length, such as 53 cm

●

a lead manufacturer, such as Medtronic

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the serial number of the lead

●

an implant date for the lead

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Implant… – Select this field to access a window that lets you view lead data exported from the analyzer or enter lead data using submenus, and to enter and view the results of defibrillation testing.

Note: If an implant procedure is in progress, measurements can be exported directly to the Implant window. Otherwise, type or select a value for each parameter.

MRI SureScan System/Other Hardware… – Select this field to access the MRI SureScan System/Other Hardware screen, which lets you enter information about leads and other hardware that may affect the decision to perform an MRI scan of this patient.

Notes – Enter an up-to-80-character note about the patient.

History… – Select this field to access a window that lets you enter and view the patient’s

clinical conditions. This information is available to the TherapyGuide feature.

EF, on – Select an ejection fraction from a table of values, and enter the measurement date.

Physician/Phone/Hospital – Enter the physician’s name, phone number, and hospital.

Last Update – Specifies the last date that changes made to patient information were

programmed into memory.

2.12.2 How to view and enter information about leads and other hardware implanted in the patient

1. Select Patient > Patient Information > MRI SureScan System/Other Hardware… to go to the MRI SureScan System/Other Hardware screen.

2. Use the fields of the MRI SureScan/Other Hardware screen to enter information about other implanted hardware, such as abandoned devices or leads and lead extenders or adaptors. Use the Other Hardware Notes field to enter an up-to-50-character note about other implanted hardware. When you are finished, select [OK].

3. Select [Program] on the Patient Information screen to program the entered patient information to the device.

The date of the last update to the information on this screen appears automatically.

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Figure 16. MRI SureScan System/Other Hardware screen

The MRI SureScan System/Other Hardware screen is designed to let you view in one place all of the hardware information that is relevant to the decision to scan the patient. Lead models and lead MR conditionality may be entered on either the Lead 1… and Lead 2… screens (available from the Patient Information screen) or the MRI SureScan System/Other Hardware screen.

MRI SureScan System fields – Specify whether the lead is MR conditional (Yes, No, Unknown), and enter a lead model. Selecting these parameter values from either the Patient Information screen or the MRI SureScan System/Other Hardware screen sets the parameters pending on both screens.

Other Hardware fields – Enter information for any implanted hardware additional to the implanted MRI SureScan system. The presence of other hardware in the patient may have an impact on whether the patient can have an MRI scan. Use these fields to specify whether any other in-use or abandoned devices, leads, lead extenders, or lead adaptors are present in the patient and to enter an up-to-50 character note providing information about this other hardware.

Last Update – Specifies the last date that changes made to this screen were programmed into memory.

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2.12.3 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 task bar.

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

3. Select [View Saved…].

4. Select which saved measurements to export. You can select up to one measurement for each lead type.

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 Atrial and RV columns in the Implant window. As described in Section 2.12.1, “How to view and enter patient information”, page 48, you can add or change an exported measurement by selecting a field in the Implant window. The exported values are programmed from the Patient Information screen.

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2.13 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.

2.13.1 Setting preferences for printing, reports, and tests

Preferences allows you to choose the printer you want to use, the number of copies to print, and whether you want to print now or later. You can choose to print reports anytime during a patient session. Your printing preferences are then 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”.

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

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2.13.1.1 How to set preferences

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

2. From the Index selection box, select the option you want: Printing, Initial Report, Final Report, or Tests.

3. Select your preferences.

4. Select [OK].

Basic printing preferences take effect immediately and are applied at the end of the current patient session. 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. The preferences you select for Final Report persist between sessions and across most applications.

The Session Summary report always prints when you request a Final Report.

The Tests preference 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 keep the waveform arrangement unchanged. For more information on tests, see Chapter 7, “System test and EP Study features”, page 310.

2.13.1.2 How to print an Initial Interrogation Report

The Initial Interrogation Report includes the Quick Look II report and the other reports you selected from the preferences on the Initial Report window. If you select the check box next to “Print Initial Interrogation Report after first interrogation” as a preference for the Initial Report, the programmer automatically prints the reports after the first interrogation in a patient session.

To print an Initial Interrogation Report for a patient session that is in progress, select the check box next to “Print Initial Interrogation Report after first interrogation”. Then end the current patient session and restart the patient session. If you have selected this option, the Initial Interrogation Report prints automatically after interrogation.

2.13.2 Printing reports during and after 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.

The system also allows you to print a summary report at the end of a patient session.

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2.13.2.1 How to print a customized set of reports

1. To print a customized set of reports, select Reports > Available Reports….

2. Select the reports you want to print. A report can be printed only if its data has been collected. If no data has been collected, the name of the report appears unavailable.

3. Select [Print Options…]. Enter number of copies and select printer preference.

4. Select [Print Now] for immediate printing, or select [Print Later] to add the print request to the print queue.

2.13.2.2 How to print a summary report for the patient session

1. Select Reports > Final Report….

2. If the printing preferences window appears, select printing preferences as desired. If the printing preferences window does not appear, the Session Summary Report and other reports you have selected print according to the previously set printing preferences.

2.13.3 Managing the Print Queue

The Print Queue window indicates the printing status of reports that you select to print as you progress through a patient session. To display the Print Queue window during a patient session, select Reports > Print Queue. From this window you can check the status of print jobs from the current patient session. You can print or delete a print job from the queue. A report cannot be deleted if its status is “printing” or “waiting”.

When you end the patient session, the Print Queue window is still available. It lists any reports held from that session and other sessions.

To display the Print Queue window when you are not in a patient session, select the Print Queue icon from the Select Model screen. The Print Queue window lists any reports held from that session and other sessions.

2.14 Transferring data to Paceart with SessionSync

The SessionSync feature enables you to transfer device data through your clinic network between the Medtronic 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.

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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 2.14.4.2, “States of the SessionSync status icon”, page 59.

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 media and retrieving, viewing, and printing data from media, see Section 2.15, “Saving and retrieving device data”, page 60.

2.14.1 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 unavailable when the feature is disabled, for example, during a patient session.

2.14.1.1 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.

2.14.2 Configuring the SessionSync network connection

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

2.14.2.1 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 – Before configuring the network connection, you need to know your SessionSync Gateway address. If you do not have your SessionSync Gateway address,

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contact your clinic’s technical support or Medtronic Paceart technical support at 1-800-PACEART.

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2.14.2.2 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].

2.14.3 Transferring device data

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

2.14.3.1 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 programmer and the Medtronic Paceart data management system.

1. Select [End Session…].

The End Session window is displayed.

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Figure 17. 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].

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 2.14.4, “Viewing the SessionSync data transfer status”, page 58, for more details about status icon indications.

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Note: If error messages appear during the data transfer process, see Section 2.14.5, “SessionSync error messages”, page 60, SessionSync error messages for a list of message descriptions.

2.14.3.2 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 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 2.14.4.2, “States of the SessionSync status icon”, page 59 for more details.

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 automatic SessionSync procedure 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 2.14.5, “SessionSync error messages”, page 60 for a list of message descriptions.

2.14.3.3 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 7. 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

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Table 7. Data transferred with SessionSync (continued)

Feature name Information exported

Threshold Tests

Sensing Tests

Automatic Diagnostics Event Counters

Device Memory Retrieved from interrogation performed only for saving session

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

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

Atrial Arrhythmia Episodes Ventricular Arrhythmia Episodes Mode Switch Episodes Rate Drop Response Episodes

data

2.14.4 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 unavailable on 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 update dynamically when the SessionSync Status window is open. To update the status, select the [Update Status] button.

2.14.4.1 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 18. SessionSync status icon on the programmer task bar

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Figure 19. SessionSync status icon indicators

1 Data management system status 2 Connection status

3 Programmer status

2.14.4.2 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 8. SessionSync status icon states

Part of SessionSync status icon Color What the color indicates

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

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

2.14.4.3 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.

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2.14.5 SessionSync error messages

Table 9. 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.

2.15 Saving and retrieving device data

The programmer allows you to save interrogated device data from a patient session to a disk or to a USB flash drive. Later, while no patient session is in progress, you can use the Read From Media application on the programmer to retrieve, view, and print previously saved data.

Note: Medtronic programmers are equipped either of two ways: with a disk drive for 90 mm (3.5 in) disks plus a USB port for USB flash drives, or with a USB port only. If your programmer has a USB port only, please disregard content in this section that documents the use of disk drives.

2.15.1 Saving device data

Any programmer equipped with a disk drive can read device data from or write device data to a disk. However, if a USB flash drive is inserted into the programmer, it overrides the disk drive for saving and retrieving device data. Disks may be used only when no USB flash drive is inserted.

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Storage requirements – To ensure the integrity and security of patient information, use a flash drive or a disk that is reserved for storage of programmer data.

Interrogate first – Interrogate the device before saving data to a USB flash drive or to a disk because the programmer saves only the data it has interrogated. If the Interrogate How Much? window is displayed, select Interrogate All to save a record of all the information from the device. If an issue needs to be investigated, selecting the All option provides more data for analysis.

Emergency functions while saving – During the save operation, the [Emergency] button remains displayed, and all Emergency functions are available. If an error occurs during a save, there may be a delay in initiating the Emergency screens. Therefore, it is suggested that you not save to media 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.

2.15.1.1 Considerations for saving device data on a USB flash drive

Insert only one USB flash drive – Insert only one writable USB flash drive at a time.

Inserting additional USB flash drives results in an error during data-saving operations and the USB indicator becomes unavailable.

Progress indicator – While a Save To Media action is in progress, the progress indicator and the message “Save To Media - In Progress” are displayed. The progress indicator displays the completion percentage. Before removing the USB flash drive, wait a few seconds after the progress indicator shows 100%.

Programmer powered on – Insert a USB flash drive only if the programmer is powered on. Insert a writable USB flash drive in the programmer using any available USB port. A slight delay may occur while the USB flash drive is authorized. The USB indicator on the task bar turns green to indicate that the USB flash drive is available for use and the disk icon becomes unavailable.

Do not insert or remove a USB flash drive during the following operations:

●

programming a device

●

performing a save-to-disk

●

performing a reload session data operation

●

saving a report as a PDF file

2.15.1.2 How to save device data to a USB flash drive

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

2. Insert a USB flash drive into the USB port on the programmer.

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3. Select Session > Save To Media….

4. Select [Save].

You can also Save To Media when you select [End Session…].

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2.15.1.3 Preparing to save data to a disk

The disk must be a formatted, IBM-compatible, 90 mm (3.5 inch) disk.

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

2.15.1.4 How to save device data to a disk

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

2. Select Session > Save To Media….

3. Insert a disk into the programmer disk drive.

4. Select [Save].

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

2.15.2 Retrieving device data

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 window is displayed because this is not a live session. Instead, the Live Rhythm Monitor window is replaced with the device model and the words Read From Media. While in the Read From Media application, the programmer allows you to view the saved data, print reports, and display all programmed parameter values.

Reports that have been saved to media can only be viewed on a computer. They cannot be viewed on the programmer itself. After saving, remove the storage media (USB flash drive or disk) containing the reports and insert it into a computer equipped to display files that are in PDF format.

All reports from one patient’s session are contained in one PDF file.

Warning: The Read From Media 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 Media application.

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

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2.15.2.1 How to read device data from a USB flash drive or a disk

1. Insert a USB flash drive or a disk 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 Media 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 Media 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 Media screen displays information from the saved session.

2.16 Patient follow-up guidelines

Schedule regular patient follow-up sessions during the service life of the device. The first follow-up session should occur within 72 hours of implant so that the patient can be checked for lead dislodgment, wound healing, and postoperative complications.

During the first few months after implant, the patient may require close monitoring. Schedule follow-up sessions at least every 3 months to monitor the condition of the patient, the device, and the leads and to verify that the device is configured appropriately for the patient.

2.16.1 Follow-up tools

The system provides several tools that are designed to increase the efficiency of follow-up sessions.

Quick Look II screen – The Quick Look II screen appears when you start the programmer application. It provides a summary of the most important indicators of the system operation and the patient’s condition since the last follow-up session.

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You can perform the following tasks from the Quick Look II screen:

●

Assess that the device is functioning correctly.

●

Review information about arrhythmia episodes and therapies.

●

Review any observations in the Observations window.

You can compare the information on the Quick Look II screen with historical information about the patient contained in printed reports. For information about printing reports, see Section 2.13, “Printing reports”, page 51. The printed reports should be retained in the patient’s file for future reference.

Checklist – The Checklist feature provides a standard list of tasks to perform at a follow-up session. You can also customize your own checklists. For more information, see Section 2.8, “Navigating a patient session with Checklist”, page 39.

Leadless ECG (LECG) – 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. You can view the Leadless ECG waveform trace on the Live Rhythm Monitor window. Leadless ECG is available in the clinic, and at remote locations. For more information, see Section 2.7, “Monitoring cardiac activity with the Live Rhythm Monitor”, page 30.

Cardiac Compass Trends – Cardiac Compass Trends provides a picture of the patient’s condition during the last 14 months. The report includes graphs that show trends in the frequency of arrhythmias, the amount of physical activity, heart rates, and device therapies. Dates and event annotations allow you to correlate trends from different graphs. The trends can also help you to assess whether device therapies or drug therapies is effective. For more information, see Section 3.5, “Cardiac Compass Trends”, page 96.

2.16.2 Reviewing the presenting rhythm

The presenting rhythm may indicate the presence of undersensing, far-field oversensing, or loss of capture. These are basic pacing issues that can affect the delivery of therapy. These issues can often be resolved by making basic programming changes.

Review the presenting rhythm by viewing the Live Rhythm Monitor and by printing the EGM and Marker Channel traces. If you identify issues with the patient’s presenting rhythm, review the device settings and reprogram the device to values that are appropriate for the patient.

2.16.3 Verifying the status of the implanted system

To verify that the device and leads are functioning correctly, review the device and lead status information, lead trends data, and Observations available from the Quick Look II screen.

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For detailed information about viewing and interpreting all of the information available from the Quick Look II screen, see Section 3.1, “Quick Look II summary data”, page 70.

2.16.3.1 How to review the Remaining Longevity estimate and device status indicators

Warning: Replace the device immediately if the programmer displays an EOS indicator. The

device may lose the ability to pace, sense, and deliver therapy adequately after the EOS indicator appears.

Review the displayed Remaining Longevity estimate. If the programmer displays the RRT indicator, contact your Medtronic representative and schedule an appointment to replace the device. For more information, see Section 3.4, “Device and lead performance data”, page 89.

2.16.3.2 How to assess the performance of the device and leads

1. To review trends in pacing impedance, capture thresholds, and P-wave and R-wave amplitude, select the [>>] button next to the lead trend graphs on the Quick Look II screen. The programmer displays a detailed history of automatic impedance, capture threshold, and sensing measurements. For more information about viewing lead performance trends data, see Section 3.4, “Device and lead performance data”, page 89.

2. If you also want to gather real-time information about the performance of the device and leads during the follow-up session, you can perform the following tests:

●

Lead Impedance Test: Compare the results of the test to previous lead impedance measurements to determine if there have been significant changes since the last follow-up session. For more information, see Section 7.4, “Lead Impedance Test”, page 316.

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Sensing Test: Compare the test results to previous P-wave and R-wave amplitude measurements. For more information, see Section 7.5, “Sensing Test”, page 317.

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Pacing Threshold Test: Use the test to review the patient’s capture thresholds. Determine the appropriate amplitude and pulse width settings to ensure capture and maximize device longevity. For more information, see Section 7.2, “Pacing Threshold Test”, page 311.

2.16.4 Verifying the clinical effectiveness of the implanted system

You can use the information available from the Quick Look II screen and in printed reports to assess whether the device is providing adequate clinical support for the patient.

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2.16.4.1 How to assess effective pacing therapy

1. Interview the patient to confirm that the patient is receiving adequate cardiac support for daily living activities.

2. Review the pacing percentages on the Quick Look II screen, and view or print Rate Histograms.

3. Review the Cardiac Compass Trends for comparison to patient history. Cardiac Compass Trends can help you to determine whether changes in the patient’s activity, pacing therapies, and arrhythmias have occurred during the past 14 months. For more information, see Section 3.5, “Cardiac Compass Trends”, page 96.

Note: Rate Histograms can also be used to assess the patient’s pacing and sensing history.

2.16.4.2 How to assess accurate tachyarrhythmia detection

The system provides diagnostic episode records to help you accurately classify the patient’s tachyarrhythmias. Review the tachyarrhythmia episode records since the last session and the Quick Look II observations. For more information, see Section 3.6, “Arrhythmia Episodes data”, page 101.

Episode misidentification – If the episode records indicate that the device has misidentified the patient’s rhythm, carefully review the tachyarrhythmia episode and sensing integrity data, the Cardiac Compass trend data, and the data stored for other episodes. Consider adjusting the detection parameters and the SVT detection criteria as needed. For more information about how to view sensing integrity data, see Section 4.1, “Sensing”, page 126.

Caution: Use caution when reprogramming the detection or sensing parameters to ensure that changes do not adversely affect VF detection. Ensure that appropriate sensing is maintained. For more information, see Section 4.1, “Sensing”, page 126.

2.16.4.3 How to assess appropriate tachyarrhythmia therapy

1. Review any Medtronic CareAlert Notifications in the Quick Look II Observations section that relate to therapy delivery. To see detailed information about Medtronic CareAlert Notifications, select Data > Alert Events.

2. Check tachyarrhythmia episode records to determine the effectiveness of therapies that have been delivered.

3. Adjust the therapy parameters as needed.

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2.17 Optimizing device longevity

Optimizing device longevity is a desirable goal because it may reduce the frequency of device replacement for patients. Optimizing device longevity requires balancing the benefit of device therapy and diagnostic features with the energy requirements placed on the battery as a result of these features.

To view the Remaining Longevity estimate for the device, refer to the Quick Look II screen.

The following sections describe strategies that may help reduce the energy requirements placed on the battery.

2.17.1 Promoting intrinsic AV conduction

Managed Ventricular Pacing (MVP) – The MVP feature promotes AV conduction by

reducing unnecessary right ventricular pacing. The primary benefit of the MVP feature is therapeutic, but it may also preserve device longevity as a result of a decrease in the percentage of pacing. For more information about the MVP feature, see Section 4.3, “Managed Ventricular Pacing (MVP)”, page 145.

Promoting AV conduction with longer AV intervals – Another method of promoting AV conduction is to increase the paced AV interval and the sensed AV interval. This action allows intrinsic conduction to occur before a ventricular pace. Fewer pacing pulses may help to preserve device longevity. For more information, see Section 4.2, “Basic pacing”, page 136.

2.17.2 Managing pacing outputs

Amplitude and pulse width – Perform a Pacing Threshold Test to determine the patient’s

pacing thresholds. Select amplitude and pulse width settings that provide an adequate safety margin above the patient’s pacing threshold. These actions decrease the pacing outputs and preserve battery energy. For more information, see Section 7.2, “Pacing Threshold Test”, page 311.

Pacing rate – The more paced events that are delivered, the more device longevity is reduced. Make sure that you have not programmed an unnecessarily high pacing rate for the patient. Carefully consider using features that increase the bradycardia pacing rate. Use features such as Atrial Preference Pacing (APP), Conducted AF Response, and Rate Response only for patients who can receive therapeutic benefit from the feature.

2.17.3 Optimizing tachyarrhythmia therapy settings

Defibrillation – To treat ventricular fibrillation episodes, the device may deliver defibrillation

therapy to terminate the episode and restore the patient’s normal sinus rhythm. The device

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can be programmed to deliver a sequence of up to 6 defibrillation therapies. Although defibrillation therapy expends a high level of energy, VF therapies should be programmed to the maximum energy level. For more information about defibrillation energy, see Section 6.5.2, “Programming VF therapies”, page 287.

Atrial cardioversion – You can program the device to deliver automatic atrial cardioversion (CV) therapies to treat atrial tachyarrhythmia episodes. If you choose to treat the patient with atrial CV therapies, you can extend device longevity by carefully considering how you program the following parameters: the number of shocks delivered during a 24-hour cycle and the Episode Duration before CV. It is recommended that CV therapy be set to full energy to terminate the arrhythmia. For more information, see Section 6.3, “Atrial cardioversion”, page 268.

Patient-activated cardioversion is another way to provide atrial cardioversion therapy. The patient can use the InCheck Patient Assistant to signal the device to deliver atrial cardioversion therapy as needed. Counsel the patient on the potential inappropriate overuse of patient-activated cardioversion that can result in decreased device longevity. For more information, see Section 6.4, “Patient-activated atrial cardioversion”, page 274.

Ventricular cardioversion – If you are providing ventricular cardioversion therapies for the patient, consider programming the therapy energy to a value lower than the maximum energy but high enough to terminate the VT. However, at least one VT therapy and one FVT therapy in a sequence should be programmed to the maximum energy level. For more information, see Section 6.7, “Ventricular cardioversion”, page 299.

FVT via VF detection – An FVT detection zone can be used to detect and treat a VT episode that is in the rate zone for VF. This approach can help maintain reliable detection of VF while allowing ATP to be delivered for fast VT episodes. For more information, see Section 5.2, “VT/VF detection”, page 206.

Antitachycardia pacing (ATP) – ATP therapies interrupt the tachycardia episode and restore the patient’s normal sinus rhythm. ATP therapies deliver pacing pulses instead of the high-voltage shocks that are delivered in cardioversion therapy and defibrillation.

ATP therapy requires less battery energy than cardioversion or defibrillation. For some patients, you may be able to program the device to deliver ATP therapies before delivering high-voltage therapies.

For more information about ATP and atrial episodes, see Section 6.2, “Atrial ATP therapies”, page 258. For more information about ATP and ventricular episodes, see Section 6.6, “Ventricular ATP therapies”, page 289.

Delivering ATP before the first defibrillation – You can program the device to deliver ATP therapy before delivering the first defibrillation therapy by enabling ATP During Charging or ATP Before Charging. This action can prevent delivery of high-voltage therapy for rhythms that can be terminated by ATP (rapid, monomorphic VT, for example).

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If you program the ChargeSaver feature to On, the device can also automatically switch to ATP Before Charging operation. This switch allows the device to attempt a sequence of ATP therapy before charging the capacitors to treat a detected VF episode. For more information, see Section 6.5, “VF therapies”, page 279.

2.17.4 Considering how diagnostic features with data storage impact longevity

Pre-arrhythmia EGM storage – Continual use of Pre-arrhythmia EGM storage reduces

device longevity. For a patient with uniform tachyarrhythmia onset mechanisms, the greatest benefit of Pre-arrhythmia EGM storage is obtained after capturing a few episodes.

When Pre-arrhythmia EGM storage is on, the device collects up to 10 s of EGM data before the onset of VT/VF, VT Monitor, or the detection of SVT episodes. The device stores up to 5 s of EGM before AT/AF detection regardless of the Pre-arrhythmia EGM storage setting.

To balance the benefit of using the Pre-arrhythmia EGM storage feature with optimizing device longevity, consider the following programming options:

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Set Pre-arrhythmia EGM storage to On to capture possible changes in the tachyarrhythmia onset mechanism following significant clinical adjustments such as device implant, medication changes, and surgical procedures. Pre-arrhythmia EGM storage may be set to On - 1 month, On - 3 months, or On Continuous. Select the setting for the shortest time period that will provide the necessary data.

●

Set Pre-arrhythmia EGM storage to Off after you have obtained the data of interest.

Note: When Pre-arrhythmia EGM storage is set to Off, the device begins to store EGM information for VT/VF, VT Monitor, and SVT episodes after the third tachyarrhythmia event occurs. Though EGM is not recorded before the start of the arrhythmia, the device still records up to 20 s of data before the onset or detection of the episode. This data includes interval measurements and Marker Channel annotations. In addition, Flashback Memory data is stored for the most recent tachyarrhythmia episodes.

Holter telemetry – Extended use of the Holter telemetry feature decreases device longevity. The Holter telemetry feature continues to transmit EGM and marker data for the programmed time duration, regardless of whether the programming head is positioned over the device.

Medtronic CareLink remote transmissions – When scheduling Medtronic CareLink remote transmissions, be aware that increasing the frequency of remote transmissions reduces implanted device service life by approximately 1 day for each additional transmission. To conserve battery energy, schedule the lowest frequency of remote transmissions that still allows for the desired monitoring of your patient’s device.

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3 Diagnostic data features

3.1 Quick Look II summary data

At the start of a patient session, it is useful to quickly view summary information about device operation and the patient’s condition. This overview can help you to determine whether you need to look more closely at diagnostic data or reprogram the device to optimize therapy for the patient.

The Quick Look II screen provides a summary of the most important indicators of the system operation and patient’s condition. It includes links to more detailed status and diagnostic information stored in the device. Device and lead status information indicates whether the system is operating as expected. Information about arrhythmia episodes and therapies provided gives a picture of the patient’s clinical status since the last follow-up appointment. System-defined observations alert you to unexpected conditions and suggest how to optimize the device settings.

Note: The Quick Look II screen shows information collected since the last patient session and stored in the device memory. Programming changes made during the current session may also affect the Quick Look II Observations.

3.1.1 How to view the Quick Look II screen

The Quick Look II screen is automatically displayed after the patient session is started. You can also access the Quick Look II screen by selecting Data > Quick Look II.

You can update the Quick Look II data during a session by reinterrogating the device.

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3.1.2 Information provided by the Quick Look II screen

The Quick Look II screen shows information in 6 sections.

Figure 20. Quick Look II screen

1 Remaining Longevity estimate 2 Lead status and trends 3 Pacing and sensing information

4 Arrhythmia episode information 5 Observations 6 Cardiac Compass Trends

If you select one of the displayed observations and more information about the selected observation is available, the [>>] button becomes active. You can use the [>>] button to look at relevant details.

3.1.2.1 Assessing the device and lead status

Remaining Longevity estimate – The device automatically calculates the estimated time

remaining until Recommended Replacement Time (RRT) based on automatic daily battery voltage measurements, time since implant, programmed parameter settings, and device recorded events. Remaining Longevity displays the estimated time remaining and a graphic that shows the RRT period in red and the estimated remaining longevity in green.

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Figure 21. Remaining Longevity estimate

1 Estimated remaining longevity to RRT (years or months) 2 RRT (red bar) 3 Estimated remaining longevity to RRT (green bar) 4 Remaining Longevity marker 5 If estimated remaining longevity to RRT is greater than 5 years, the green bar is full

Select the Remaining Longevity [>>] button to see more detailed battery and lead measurement data. The Battery and Lead Measurements screen and its associated printed report provide the most recent Remaining Longevity estimates, battery voltage measurement, and RRT indicator with date and time, if applicable. For more information, including the date when the battery reaches RRT, see Section 3.4, “Device and lead performance data”, page 89.

Lead status and trends – Information about lead status allows you to assess the performance and integrity of leads and identify any unusual conditions. The “Last Measured” column shows the most recently measured lead impedance for each lead.

Select the [>>] button in the “Last Measured” column to see more detailed lead measurements and relevant programmed settings.

The lead trend graphs on the Quick Look II screen show lead impedance, capture threshold, and sensing amplitude measurements recorded over the last 12 months.

Select the [>>] button beside any of the lead trend graphs to see more detailed information about lead performance. The detailed trend graphs display up to 15 of the most recent daily measurements and up to 80 weekly summary measurements (showing minimum, maximum, and average values for each week).

For more information about lead performance graphs, see Section 3.4, “Device and lead performance data”, page 89.

3.1.2.2 Assessing the patient’s condition

Pacing and sensing information – This information can help to assess the patient’s AV

conduction status and evaluate the effectiveness of programmed device settings.

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Information about atrial and ventricular pacing and sensing is shown as percentages of the total time during the reporting period. This includes the percentage of time that AS-VS, AS-VP, AP-VS, and AP-VP event sequences occurred.

“MVP On” and “MVP Off” refer to the currently programmed pacing mode, not the usage of MVP mode pacing since the last session. If the device was programmed to an MVP mode during the reporting period, a high percentage of ventricular pacing may indicate that the patient has heart block.

The percentage of time that the patient experienced AT/AF can help you to assess the need to adjust the patient’s device or drug-based therapies. The time in AT/AF is calculated from the point of AT/AF onset. For more information, see Section 5.1, “AT/AF detection”, page 200.

Note: The paced and sensed event counters do not count all events recorded by the device. For example, a ventricular safety pace is considered to be a pace, and the preceding ventricular sense is not counted. Due to rounding, percentages may not add up to 100%.

Arrhythmia episode information – This section shows the number of treated and monitored arrhythmia episodes that have occurred since the last patient session. It also shows the number of shocks that were delivered since the last session. In addition, it shows the number of episodes for which ventricular oversensing (VOS) was detected by the TWave Discrimination feature or the RV Lead Noise Discrimination feature.

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Note: SVT episodes in the Monitor zone are not included in the Monitored SVT episodes count.

Select the [>>] button to review details of all arrhythmia episodes. For more information, see Section 3.6, “Arrhythmia Episodes data”, page 101.

3.1.2.3 Quick Look II Observations

Observations are based on an analysis of programmed parameters and data collected since the last session.

Note: Conditions that prevent diagnostic data from being collected are reported as Quick Look II observations. When MRI SureScan is programmed to On, diagnostic data is not collected. If the device detects an MRI SureScan session, an observation like the following is reported: “MRI SureScan On: 23-April-2013 08:33:11. MRI SureScan Off: 23-April-2013 09:33:11. Data was not collected during MRI SureScan.” Refer to the MRI Technical Manual for additional information.

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The following types of observations may occur:

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Device status observations inform you when the device is approaching RRT or End of Service (EOS). An observation is also reported if a charge circuit irregularity or device reset has occurred.

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Lead status observations report any potential issues with the sensing integrity of the leads and possible lead dislodgments. You may also be warned about possible inconsistencies in the programming of lead polarity.

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Parameter observations warn of any inconsistencies in the programming of detection and therapy parameters. One example is if certain parameter settings result in a therapy being disabled.

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Diagnostic data observations report noteworthy arrhythmia episodes. Examples include arrhythmias of different types occurring together and episodes for which therapies were unsuccessful. Conditions that prevent diagnostic data from being collected are also reported.

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Medtronic CareAlert observations can report system or device performance conditions and certain heart rhythm conditions. For more information, see Section 3.2, “Medtronic CareAlert events and notifications”, page 74.

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Clinical status observations inform you of abnormal patient conditions, such as low activity rates, unexpectedly high heart rates, high arrhythmia burden, or fluid accumulation.

3.2 Medtronic CareAlert events and notifications

Important clinical management and system performance events may occur between scheduled patient sessions. These events may relate to clinical management data stored in device memory or to inappropriate programmed settings or system issues that should be investigated. The early detection and notification of these events, should they occur, enable you to intervene promptly with appropriate care for your patient.

The device continuously monitors for a specified set of clinical management and system performance events that may occur between scheduled follow-up sessions. If the device detects that such an event has occurred and if alerting parameters are turned on, it responds in the following ways:

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Wireless signal and network transmission of event information

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Medtronic CareAlert Monitoring continuously monitors for alert events. If an event occurs, CareAlert Monitoring sends a wireless alert signal to your patient’s Medtronic patient monitor. Upon receiving a signal, the monitor transmits the alert data to the Medtronic CareLink Network, if programmed to do so.

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Notification of alert event

Depending on the severity of the alert condition, you can set up Medtronic CareAlert Notifications through the CareLink Network (if available) to hold the alert for routine review at your office via email or the CareLink website or to notify you immediately via voice message, text message, pager, email, website, or live call.

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Patient alert

The device emits 1 of 2 tones to alert your patient, depending on the type and urgency of the event that has occurred. The patient then responds according to your instructions.

3.2.1 Clinical management and system performance event alerts

3.2.1.1 Clinician-defined alerts (programmable)

Clinical Management Alerts

AT/AF Daily Burden > Threshold

Avg. V. Rate During AT/AF > Threshold

Number of Shocks Delivered in an Episode

All Therapies in a Zone Exhausted

Lead and Device Integrity Alerts

RV Lead Integrity This alert indicates that an RV lead problem is suspected, which

RV Lead Noise This alert indicates that noise was detected on the RV lead, which

This alert indicates that the cumulative time in AT/AF exceeds the programmed threshold.

This alert indicates that the average ventricular rate during a selectable duration of AT/AF exceeds the programmed threshold.

This alert indicates that the number of shocks delivered in a VT/VF episode is greater than or equal to the programmed Number of Shocks Threshold.

This alert indicates that a specific VF, VT, or FVT episode was redetected after all programmed therapies for that type of episode were delivered.

could indicate lead fracture. The device immediately sounds an alert tone that lasts for 30 s. This tone repeats every 4 hours, beginning at the next scheduled 4-hour time interval, and at the programmed daily alert time.

could indicate lead fracture, breached lead insulation, lead dislodgement, or improper lead connection. The device sounds an alert tone 3 min after a lead noise episode is detected. This tone repeats every 4 hours, beginning at the next scheduled 4-hour time interval, and at the programmed daily alert time.

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VF Detection/Therapy Off This alert indicates that one or more of the following conditions has

occurred for at least 6 hours since the last programming: VF detection has been turned off; 3 or more VF therapies have been turned off; or FVT detection is programmed to FVT via VF and 3 or more FVT therapies have been turned off. Note that this alert sounds immediately and then every 6 hours until cleared.

Low Battery Voltage Recommended Replacement Time

Excessive Charge Time End of Service

(Lead Name) Impedance Out of Range

This alert indicates that the daily automatic battery voltage measurement has been at or below the Recommended Replacement Time voltage level for 3 consecutive days.

This alert indicates that the charging period equals or exceeds the charge time threshold.

This alert indicates that the daily lead impedance measurement for the (lead name) is out of range. This could indicate that the lead has dislodged or is improperly connected. For all leads, the device sounds an alert tone at the programmed daily alert time. For the RV Pacing, RV Defibrillation and SVC leads, the device also immediately sounds an alert tone and repeats this tone every 4 hours, beginning at the next scheduled 4-hour time interval.

For details about programmable settings for a particular parameter, see the device manual for the specific device.

3.2.1.2 System-defined alerts (non-programmable)

Electrical Reset This alert indicates that the device has been reset and may require

reprogramming. The device immediately sounds a high-urgency alert tone that repeats every 20 hours or every 9 hours, depending on the type of electrical reset. Immediately contact your Medtronic representative if an Electrical Reset alert occurs. For electrical reset parameter values, see the device manual for the specific device.

Pacing Mode DOO, VOO, or AOO

Active Can Off without SVC This alert indicates that the Active Can feature is disabled without an

This alert indicates that the device is programmed to DOO, VOO, or AOO pacing mode and, as such, does not deliver tachyarrhythmia therapy. The device sounds a high-urgency tone daily at the programmed time.

SVC lead in place, which does not provide a viable defibrillation pathway. The device sounds a high-urgency tone daily at the programmed time.

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Charge Circuit Timeout This alert indicates that a charging period has exceeded the maxi-

mum time allowed for capacitor charging. The device immediately sounds a high-urgency alert tone that repeats every 20 hours. Contact your Medtronic representative if a Charge Circuit Timeout alert occurs.

Unsuccessful Wireless Transmission

An Electrical Reset alert sounds immediately and then every 20 hours thereafter. However, if the electrical reset disables tachyarrhythmia detection and therapy, the alert sounds immediately and then every 9 hours thereafter. Contact your Medtronic representative if an electrical reset alert sounds.

This alert indicates that the device attempted a wireless transmission, but that the transmission was still unsuccessful after a 72-hour period during which the device retried the transmission every 3 hours.

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3.2.2 Operation of Medtronic CareAlert Monitoring and Medtronic CareAlert Notifications

If a clinical or system performance event occurs and the device is programmed to notify you over the CareLink Network, CareAlert Monitoring automatically attempts to establish wireless communication between the device and the monitor. Once communication is established, the monitor receives the alert data from the device. The monitor then transmits the alert data to the CareLink Network. The CareLink Network records the alert, and you are notified based on your preferences. The monitor communicates back to the device when the data transmission is successful. If a data transmission is unsuccessful at first, CareAlert Monitoring attempts to establish wireless communication with the monitor every 3 hours until the transmission is successful. If a transmission is still unsuccessful after 72 hours, the device emits a backup tone at the Alert Time that you select for your patient or at intervals unique to some alerts as described in Section 3.2.1.1, “Clinician-defined alerts (programmable)”, page 75 and Section 3.2.1.2, “System-defined alerts (nonprogrammable)”, page 76. A transmission includes data for all active alerts.

Note: After a wireless alert signal has been successfully transmitted, the device does not retransmit data for that particular alert until the alert is cleared, even if the threshold for the alert is met again in the interim. However, the device continues to emit alert tones each day for active alerts that have Device Tone set to On. There are no such tones emitted for alerts that have Device Tone set to Off.

The CareAlert Notification methods (any one or a combination of voice message, text message, pager, email, website, or live call) are set on a per-clinic basis according to alert urgency and time of day. You can assign the level of urgency to each alert for individual patients, so that the same alert can be high urgency for one patient and low urgency for another patient.

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Figure 22. Process for transmitting Medtronic CareAlert Notifications

1 The device detects an alert condition and establishes wireless communication with the monitor. 2 The monitor sends the alert data to a secure server via the patient’s telephone land line or cellular

telephone connection.

3 If the CareLink Network is configured to do so, the clinician is notified via voice message, text

message, pager, email, website, or live call. The clinician can then consult the network for detailed information.

3.2.3 Operation of Medtronic CareAlert events

Medtronic CareAlert events trigger patient alerts that are clinician-defined or system-defined and emit tones that can be differentiated using 2 levels of urgency:

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Clinician-defined alerts may be programmed as high-urgency or low-urgency and may be turned on or off.

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System-defined alerts are high-urgency, and they are always on.

High-urgency alerts emit a dual, high-low tone. Low-urgency alerts emit an intermittent on-off tone. High-urgency tones may indicate that there is a device problem that needs immediate attention. Alerts are displayed in the Observations window on the Quick Look II and Alert Events screens of the Medtronic programmer.

When an alert is initiated, the device emits the tone pattern either at a selected time of day or at a fixed time interval. The tone then sounds each day at the selected time or interval until the alert is cleared (or until Device Tone is set to Off). Active tones also sound when the patient magnet is placed over the device. You can view alert details on a programmer during a patient session.

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Notes:

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A CareLink transmission does not clear an alert tone from sounding. The tone will continue to sound until the alert is cleared (or until the Device Tone is set to Off).

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Once an alert has been successfully transmitted over the CareLink Network (if available), further transmissions for that alert condition will not occur until the alert is cleared.

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All alerts are cleared automatically when the device is interrogated with a programmer.

3.2.3.1 Patient alert process

If a clinical management or system performance event occurs and the device is programmed to sound a patient alert, the device emits alert tones at any or all of the following times, depending on the event: when the event occurs, at a programmed time of day, at fixed intervals. Instruct your patient to call the clinic if the patient hears tones coming from the device. Alert tones last for up to 30 s and are slightly louder than typical living room noise. If both high-urgency and low-urgency alerts are active at the same time, the high-urgency alert is given priority and sounds at the appropriate time or interval.

Although the system provides 2 types of alert tones for high-urgency and low-urgency clinical scenarios, it is important to remember that the patient may hear identical tones whether the alert is caused by a system performance issue or by a significant clinical event. Because the tones may be identical, a patient may not be able to distinguish between a system performance alert and a clinical event alert. The patient alert tone is only intended to prompt the patient to contact you. You should be aware that a patient who hears an alert tone will contact you to determine the type of alert that has occurred, the information the device has recorded, and how you interpret the data to assist in a plan of care. The details related to the alert, including the type of alert and detailed findings, are only available to the patient through discussion with you.

3.2.3.2 Selecting a patient alert time

The system allows you to select the time of day that a patient alert sounds. The alert tone continues to sound each day at the selected time until the alert is cleared (or until the Device Tone is set to Off). Select a time when the patient or a companion is most likely to hear the tone. The following patient factors may influence your selection of the alert time:

●

when the patient will be in a predictably quiet setting

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the patient’s daily schedule; for example, medication routines that may affect alertness

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the patient’s hearing acuity

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the presence or absence of companions who might also hear the tones

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Note: Some patient alerts will also sound at times other than the programmed alert time. See Section 3.2.1.1, “Clinician-defined alerts (programmable)”, page 75 and Section 3.2.1.2, “System-defined alerts (non-programmable)”, page 76 for exceptions.

If the conditions that trigger an alert are intermittent, the alert event may not actually be present when the alert tone sounds. Also, the alert time is based on the internal device clock. It does not adjust for time zone changes.

3.2.3.3 Programming a patient alert time

Tones for some system alerts are synchronized to the time you program tones for clinician-defined alerts. To program an alert time, select Params > Alert… > Alert Time….

However, if you program all clinician-defined alerts to Off, the Alert Time field is not shown. In this situation, perform the following steps to program the Alert Time for these system alert tones:

1. Program one of the programmable alerts to On to display the Alert Time field.

2. Select an alert time to apply to system alerts.

3. Reprogram the alert to Off.

3.2.3.4 Instructing the patient

It is important that patients understand that they may hear alert tones emitted from implanted devices. They must know what to do when an alert sounds.

Warning: Make sure that patients understand that they must not carry, store, or leave the patient magnet positioned over the device. Device operation is temporarily impaired when the magnet is placed over the device and it must be moved away from the device to restore normal operation.

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Instruct patients to contact you immediately if they hear ANY tones from the device.

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Advise patients of the time of day that you have programmed an alert tone to sound. If a tone sounds, they should expect it to sound every day at that time until the alert is cleared (or until the Device Tone is set to Off).

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For patients with a Medtronic monitor, advise them that if an alert is not successfully transmitted to the monitor within 72 hours, a high-urgency tone sounds each day at the programmed alert time.

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Make sure patients know that the alert time does not adjust for time zone changes.

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Advise patients that they may hear a steady test tone or any active alert tones if they are in the presence of a strong electromagnetic field, such as the field within a store theft detector. Advise patients that the device operation is temporarily impaired in these situations and that they should move away from the source of the interference to restore normal device operation.

Patients should also understand the purpose of the patient magnet and how and when to use it. Make sure that they know that current patient alerts sound when the patient magnet is placed over the device. Demonstrate how to place the patient magnet over the device to replay the alert tones, and review the patient magnet manual with them. Patients can use a folded patient magnet manual as a reference card.

3.2.3.5 Demonstrating alert tones

During a patient session, you can demonstrate high-urgency tones, low-urgency tones, and the test tone from the programmer as follows:

1. Select the Params icon.

2. Select Alert….

3. Select [Demonstrate Tones…].

4. Select [High-Urgency Condition Met], [Low-Urgency Condition Met], or [No Conditions Met].

Note: Any active alert tones will sound when the patient magnet is placed over the device. If there are no active alerts, the steady test tone will sound.

3.2.4 Programming Alerts

Note: The Medtronic CareAlert Setup screen shows either a Lead/Device Integrity Alerts

view or a Clinical Management Alerts view. To switch between views, select either [Clinical Management Alerts…] or [Lead/Device Integrity Alerts…].

Note: Programming each Device Tone alert includes setting the alert urgency. Alerts for the Patient Home Monitor do not have an urgency setting.

Table 10. How to navigate to parameters for Lead/Device Integrity Alerts

Parameters Path

Patient Home Monitor (Yes, No) Alert Time…

Alert Urgency (High, Low) RV Lead Integrity (On, Off) RV Lead Noise (On, Off)

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Params > Alert… > Lead/Device Integrity Alerts…

Params > Alert… > Lead/Device Integrity Alerts… > RV Lead…

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Table 10. How to navigate to parameters for Lead/Device Integrity Alerts (continued)

Parameters Path

Lead Impedance Out of Range Alert Urgency (High, Low) A. Pacing (On, Off [Observation only]) RV Pacing (On, Off [Observation only]) RV Defibrillation (On, Off [Observation only]) SVC Defibrillation (On, Off [Observation only])

Low Battery Voltage RRT Alert Enable – Urgency (On-High, On-Low, Off)

Excessive Charge Time EOS Alert Enable – Urgency (On-High, On-Low, Off)

VF Detection OFF, VF or FVT Therapies Off (On-High, Off)

Params > Alert… > Lead/Device Integrity Alerts… > Lead Impedance Out of Range… > Lead Impedance > Enable

Params > Alert… > Lead/Device Integrity Alerts… > Low Battery Voltage RRT…

Params > Alert… > Lead/Device Integrity Alerts… > Excessive Charge Time EOS…

Params > Alert… > Lead/Device Integrity Alerts… > VF Detection OFF, 3+ VF or 3+ FVT Rx Off

Table 11. How to navigate to parameters for Clinical Management Alerts

Parameters Path

Patient Home Monitor (Yes, No) Alert Time (all others)…

AT/AF Daily Burden (On, Off [Observation only]) Burden

Avg. V. Rate During AT/AF (On, Off [Observation only]) Burden V. Rate

Number of Shocks Delivered in an Episode (On, Off) Alert Enable – Urgency (On-High, On-Low, Off) Number of Shocks Threshold

All Therapies in a Zone Exhausted for an Episode Alert Enable – Urgency (On-High, On-Low, Off)

Params > Alert…

Params > Alert… > AT/AF Burden and Rate Settings…

Params > Alert… > Number of Shocks Delivered in an Episode…

Params > Alert… > All Therapies in a Zone Exhausted for an Episode.

Transmitting alerts – The ability to transmit Medtronic alerts to the CareLink Network is programmable only when the Patient Home Monitor field on the programmer screen is programmed to Yes.

Repetitive alerts – If a programmable alert is triggered so often that it loses its clinical value, you may want to consider adjusting the alert threshold, programming the device to improve therapy effectiveness, or turning off the alert.

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3.2.5 Evaluation of alert events

The device stores alert events in the Medtronic CareAlert Events log. The programmer screen refers to alert events as Alert Events. For each alert event, a log entry includes the date and time of the alert, a description of the event, and the measurement or information that caused the event. Up to 15 Alert Events are stored. Alert data is cleared only when you clear all device data from the Data Collection Setup screen.

To access alert events, select Data > Alert Events.

3.3 RV Lead Integrity Alert

RV lead fractures can cause oversensing, which can lead to inappropriate tachyarrhythmia detection and shock. While some lead fractures occur suddenly and provide little warning, other fractures are preceded by rapid, unexpected changes in lead impedance and short episodes of oversensing. Monitoring for these changes may provide patients with enough advance warning of a potential lead problem to avoid an inappropriate shock.

Medtronic leads – When used with Medtronic Fidelis leads, the RV Lead Integrity Alert feature is designed to extend the advance warning time of a potential lead-related issue, improve opportunities for more patients to recognize the audible alert, and reduce inappropriate shocks. The RV Lead Integrity Alert feature is intended for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and

6930), based on performance data.

St. Jude Riata/Durata lead families – A retrospective analysis of data from the CareLink system was performed to evaluate the performance of RV LIA compared to pace/sense monitoring in St. Jude Riata/Durata lead families (n=6,123 as of October 2011).

Boston Scientific Endotak lead families – A retrospective analysis of data from the CareLink system was performed to evaluate the performance of RV LIA compared to pace/sense monitoring in Boston Scientific Endotak lead families (n=5,114 as of October

2011).

The RV LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific Endotak lead as it does with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA feature. The RV Lead Integrity Alert feature detects issues with the pace/sense conductor only, and does not provide warning of issues related to the high voltage conductor.

The RV Lead Integrity Alert feature is not intended to withhold therapy for true VT or VF. To identify a potential lead issue, the RV Lead Integrity Alert monitors RV pacing lead impedance measurements, the frequency of rapid non-sustained VT episodes, and the frequency of short ventricular intervals counted on the Sensing Integrity Counter.

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RV bipolar OR RVtip-to-coil

lead impedance

Response

Sensing Integrity Counter

High Rate-NS episodes

60 days

2 of 3 criteria

are met

CareAlert notification

Suspend detection during nonwireless telemetry

Adjustments to tachyarrhythmia detection

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If the possibility of an impending RV lead fracture is indicated by the data, the RV Lead Integrity Alert feature can trigger a Medtronic CareAlert Notification and an alert tone to warn the patient. In addition, the RV Lead Integrity Alert feature automatically adjusts tachyarrhythmia detection settings and diagnostic settings to avoid the delivery of an inappropriate shock.

The RV Lead Integrity Alert feature is only one part of an overall monitoring and diagnostic plan. Consequently, if the Medtronic ICD or CRT-D device is sounding an audible alert tone or if the programmer indicates that an alert event has occurred, review the alert messages and evaluate the diagnostic data to determine the likelihood of a lead integrity issue.

3.3.1 Operation of RV Lead Integrity Alert

Figure 23. Operation of RV Lead Integrity Alert

1 Lead Integrity Alert impedance is evaluated for both RV bipolar and RV tip-to-coil pacing

polarities. If either measurement goes out of range, the impedance criterion is met.

The device continually monitors for a potential RV lead fracture using lead impedance measurements for both RV pacing lead polarities, the Sensing Integrity Counter, and High Rate-NS episode data. It identifies a potential lead fracture if at least 2 of the following criteria have been met within the past 60 days:

●

An RV pacing lead impedance measurement for either polarity is less than 50% or greater than 175% of the baseline impedance. The baseline measurement is the median of the previous 13 daily measurements. A separate baseline is calculated for each RV pacing vector. The RV bipolar and RV tip-to-coil impedance measurements are taken at the same time each day.

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●

The ventricular Sensing Integrity Counter is incremented by at least 30 within a period of

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3 consecutive days or less.

Note: The Sensing Integrity Counter total displayed on the Battery and Lead Measurements screen is the number of short ventricular intervals that occurred since the last patient session. Therefore, the total could exceed 30 without satisfying the alert criteria if the total was reached during a period of more than 3 consecutive days.

●

The device senses 2 High Rate-NS episodes with a 4-beat average R-R interval of less than 220 ms.

If either the Device Tone or the Patient Home Monitor alert parameter for the RV Lead Integrity Alert is programmed to On, the device responds to a potential RV lead fracture with an alert tone, a Medtronic CareAlert Notification, and automatic adjustments to tachyarrhythmia detection. When at least 1 High Rate-NS episode occurs or if the alert criteria are met, the device automatically adjusts EGM storage operation.

If both the Device Tone and the Patient Home Monitor alert parameters for the RV Lead Integrity Alert are programmed to Off, the device does not trigger a Medtronic CareAlert Notification or an alert tone, and it does not adjust tachyarrhythmia detection parameters. However, it records a Quick Look II observation for the lead warning, and it makes adjustments to EGM storage.

3.3.1.1 RV Lead Integrity Alert tones and CareAlert Notifications

When the criteria for the RV Lead Integrity Alert are met, the device immediately sounds an alert tone. The tone sounds again every 4 hours beginning at the next scheduled 4-hour time interval (00:00, 04:00, 08:00…). The tone also sounds at the programmed Alert Time and when a magnet is placed over the device. The tone continues to sound until the alert is cleared (or until Device Tone is set to Off). If the Patient Home Monitor alert for the RV Lead Integrity Alert is programmed to On, the device also attempts to send a wireless transmission to the Medtronic patient monitor.

3.3.1.2 Automatic adjustments to tachyarrhythmia detection

When the RV Lead Integrity Alert is triggered, the device automatically programs the VF Initial Beats to Detect parameter to 30/40 (if it was less). If necessary, the device automatically adjusts the Monitored VT Beats to Detect parameter and sets AT/AF Detection to Monitor.

In addition, after the RV Lead Integrity Alert has been triggered, the device automatically suspends tachyarrhythmia detection when it is interrogated using nonwireless telemetry by a programmer or a Medtronic patient monitor. The device suspends detection to prevent inappropriate therapy delivery during the telemetry session when a lead issue is suspected.

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During a Medtronic patient monitor session, tachyarrhythmia detection resumes automatically when the interrogation is complete. During a programmer session, tachyarrhythmia detection can be resumed by selecting [Resume] at the top of the programmer screen, by removing the programming head, or by ending the session and removing the programming head.

Note: This suspension behavior occurs for all nonwireless sessions until 3 days have passed since the alert was cleared or the device was interrogated.

3.3.1.3 EGM storage changes

When at least 1 High Rate-NS episode occurs, the device automatically adjusts EGM storage operation in order to provide more diagnostic data to help identify a lead-related issue. The device programs the Pre-arrhythmia EGM parameter to On - 1 month (unless the previous setting provided more than 30 days of Pre-arrhythmia EGM storage remaining).

Notes:

●

The Pre-arrhythmia EGM parameter displays the programmed setting even when the device adjusts EGM storage automatically after a High Rate-NS episode has occurred.

●

The changes to EGM storage occur even when the Device Tone and Patient Home Monitor alert parameters for RV Lead Integrity Alert are programmed to Off.

If the Lead Impedance and Sensing Integrity Counter criteria are met, the device also changes the criteria for storing High Rate-NS episodes, allowing a High Rate-NS episode with EGM data to be recorded if a single ventricular interval less than 200 ms occurs. This condition persists until a High Rate-NS episode occurs or until you interrogate the device.

3.3.2 Programming RV Lead Integrity Alert

Note: The Medtronic CareAlert Setup screen shows either a Lead/Device Integrity Alerts

view or a Clinical Management Alerts view. To switch between views, select either [Clinical Management Alerts…] or [Lead/Device Integrity Alerts…].

Note: Programming each Device Tone alert includes setting the alert urgency. Alerts for the Patient Home Monitor do not have an urgency setting.

To navigate to the RV Lead Integrity Alert parameter, select Params > Alert… > Lead/Device Integrity Alerts… > RV Lead….

VF Detection and VF therapies – If you program VF Detection or all of the VF therapies to Off, the RV Lead Integrity Alert does not operate. The RV Lead Integrity Alert operation resumes when you program VF Detection and the VF therapies to On, and only the data collected after that time are applied to the alert criteria.

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3.3.3 Evaluation of RV Lead Integrity Alert

If the device is sounding an alert tone or if the programmer indicates that an alert event has occurred, review the alert messages and evaluate the diagnostic data to determine the likelihood of a lead integrity issue.

3.3.3.1 CareAlert window

When the device is interrogated, a CareAlert window notifies you that an alert condition exists, including the RV Lead Integrity Alert.

3.3.3.2 Quick Look II observations

Check the Quick Look II Observations list to verify that there is an RV Lead Integrity warning by selecting Data > Quick Look II.

For detailed information about viewing and interpreting all of the information available from the Quick Look II screen, see Section 3.1, “Quick Look II summary data”, page 70.

3.3.3.3 Medtronic CareAlert Events

Check the CareAlert Events list to verify that there is an RV Lead Integrity warning by selecting Data > Alert Events.

3.3.3.4 Sensing Integrity Counter

To access the Sensing Integrity Counter, select Data > Device/Lead Diagnostics > Battery and Lead Measurements > [Open Data].

Sensing Integrity Counter – Check the Sensing Integrity Counter section of the Battery and Lead Measurements screen for evidence of oversensing. For more information, see Section 3.4, “Device and lead performance data”, page 89.

3.3.3.5 Arrhythmia Episodes (High Rate-NS)

If an RV Lead Integrity warning is present in Quick Look II Observations, select the Observations [>>] button on the Quick Look II screen, or select Data > Clinical Diagnostics > Arrhythmia Episodes > [Open Data].

Check the High Rate-NS episodes in the Arrhythmia Episodes window. A High Rate-NS episode has an average ventricular rate greater than 273 bpm (less than 220 ms). If there are 2 or more High Rate-NS episodes, lead noise oversensing may have occurred. Review the stored EGM to determine the cause of the oversensing.

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Figure 24. High Rate-NS episode record

1 Average rate information

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3.3.3.6 Lead Trends

To access lead impedance trends, select Data > Device/Lead Diagnostics > Lead Impedance Trends > [Open Data].

Check the Lead Impedance Trends for a sudden change in either the RV bipolar impedance or the RV tip-to-coil impedance measurement. If at least 1 measurement is greater than 175% of the baseline value or is less than 50% of the baseline value, then the lead impedance should be considered abnormal.

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Figure 25. RV Lead Impedance Trend data

1 Baseline value 2 Abnormal impedance measurements

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3.4 Device and lead performance data

The device automatically measures and records device and lead performance data every day. Detailed views of this data are available from the Battery and Lead Measurements screen and the Lead Trends screen.

3.4.1 Viewing battery and lead measurement data

The Battery and Lead Measurements screen displays the most recent values for key measures of device and lead performance. These may include automatically measured values or those measured during manual system tests.

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3.4.1.1 How to view battery and lead measurement data

To access battery and lead measurement data, select Data > Device/Lead Diagnostics > Battery and Lead Measurements > [Open Data].

Figure 26. Battery and Lead Measurements screen

1 Remaining Longevity information 2 Battery Voltage information 3 Capacitor charging information 4 Sensing Integrity Counter 5 Result of the last Atrial Lead Position Check 6 Most recent lead impedance measurements 7 Most recent daily automatic sensing amplitude measurements 8 Information about the last delivered high-voltage therapy 9 Select [Print…] to print a Battery and Lead Measurements Report

3.4.1.2 Remaining Longevity estimate

The device automatically calculates the estimated time remaining until RRT based on automatic daily battery voltage measurements, time since implant, programmed parameter settings, and device recorded events. The estimated Remaining Longevity, minimum longevity, and maximum longevity are reported in years or months. The estimated Remaining Longevity is also reported in a graphic for easy reference with the RRT period in red and the estimated remaining longevity in green.

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Figure 27. Remaining Longevity estimate

1 Estimated remaining longevity to RRT (years or months) 2 Minimum and Maximum remaining longevity to RRT (years or months) 3 RRT (red bar) 4 Estimated remaining longevity to RRT (green bar) 5 Remaining Longevity marker 6 If estimated remaining longevity to RRT is greater than 5 years, the green bar is full

Table 12. Remaining Longevity examples

Remaining Longevity Infor-

Device Scenario Device Status

Before implant - VF detection Off

Before implant - the device may have been exposed to cold temperatures

Immediately after implant - VF detection On

Recommended Replacement Time (RRT)

End of Service (EOS) Replace Device EOS EOS and the RRT date are dis-

Device Electrical Reset Re-Initializing The bar on the graphic is gray

Pre-Implant The bar on the graphic is green

Pre-Implant The bar on the graphic is gray

Initializing Remaining longevity estimator

Replace Device RRT RRT and the RRT date are dis-

mation

and the estimated remaining longevity to RRT is > 5 years.

and estimated remaining longevity to RRT is not reported.

is initializing. Longevity estimate will be available within 24 hours.

played.

and estimated remaining longevity values will be available within 1 week.

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3.4.1.3 Battery voltage and replacement indicators

The device measures the battery voltage automatically when telemetry is initiated at the start of a session, when a lead impedance test is performed, and every day at 02:15 as part of the automatic daily measurements. The battery voltage measurement at the start of a session is displayed on the Battery and Lead Measurements screen. The automatic daily battery voltage measurements are used in the calculation of Recommended Replacement Time (RRT).

Note: You may see a temporary drop in the displayed battery voltage if high-voltage charging has occurred within the past 7 days.

If 3 consecutive automatic daily battery voltage measurements are less than or equal to the Recommended Replacement Time (RRT) value, the programmer displays the RRT indicator and the date when the battery reached RRT. If the programmer displays the RRT indicator, contact your Medtronic representative and schedule an appointment to replace the device.

The expected service life of the device after RRT, defined as the Prolonged Service Period (PSP), is 3 months (90 days).3 After the 90-day PSP has expired, the device reaches End of Service (EOS) and the programmer displays the EOS indicator.4

Warning: Replace the device immediately if the programmer displays an EOS indicator. The device may lose the ability to pace, sense, and deliver therapy adequately after the EOS indicator appears.

3.4.1.4 Capacitor charging and high-voltage therapy information

The Battery and Lead Measurements screen reports information about the last high-voltage charge and the last delivered high-voltage therapy. The Last Charge section displays the date, charge time, and energy range from the last time the high-voltage capacitors were charged (from any starting energy to any final energy). This information includes periodic charging (if necessary) to condition the battery. The Last High Voltage Therapy section reports the date, measured impedance, delivered energy, waveform, and pathway for the last delivered high-voltage therapy.

EOS may be indicated before the end of 90 days if the actual battery usage exceeds the expected conditions during the Prolonged Service Period.

EOS may also be indicated if an excessive charge time occurs.

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3.4.1.5 Sensing Integrity Counter

When the device senses high-frequency electrical noise, the result is often a large number of ventricular sensed events with intervals near the programmed value for ventricular blanking after a ventricular sense (V. Blank Post VS). The Sensing Integrity Counter records the number of ventricular events with intervals that are within 20 ms of the V. Blank Post VS parameter value. A large number of short ventricular intervals may indicate oversensing, lead fracture, or a loose setscrew. If the Sensing Integrity Counter reports more than 300 short ventricular intervals, investigate potential sensing and lead integrity issues. For more information, see Section 3.3, “RV Lead Integrity Alert”, page 83, and Section 5.9, “RV Lead Noise Discrimination”, page 246.

3.4.1.6 Atrial Lead Position Check results

The device can be programmed to automatically disable atrial tachyarrhythmia therapies if the daily Atrial Lead Position Check identifies a potential problem with the lead position. The Battery and Lead Measurements screen displays the result of the most recent Atrial Lead Position Check. For more information, see Section 6.1, “Atrial therapy scheduling”, page 251.

3.4.1.7 Lead impedance and sensing amplitude measurements

The Battery and Lead Measurements screen displays recent lead impedance and sensing amplitude measurements. For lead impedance measurements, the screen displays the most recent manual measurements or the most recent daily automatic measurements. For sensing amplitude measurements, the screen displays the most recent daily automatic measurements. Measurements performed with the manual Sensing Test are not displayed on the Battery and Lead Measurements screen. For more information about performing manual lead impedance measurements, see Section 7.4, “Lead Impedance Test”, page 316. For more information about performing manual sensing amplitude measurements, see Section 7.5, “Sensing Test”, page 317.

You can compare the most recent measurements to the trends of daily automatic measurements by selecting the Lead Impedance [>>] button or Sensing [>>] button to view the Lead Trends screen. In addition, if the Lead Trends screen is displayed, you can select any measurement trend data from the menu on the Lead Trends screen.

3.4.2 Viewing lead impedance trends

Every day at 03:00, the device automatically measures the lead impedance on each implanted lead using subthreshold electrical pulses. These pulses are synchronized to sensed or paced events and do not capture the heart.

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The daily automatic lead impedance measurements are displayed on the Lead Trends screen, which plots the data as a graph. The graph displays up to 15 of the most recent measurements and up to 80 weekly summary measurements (showing minimum, maximum, and average values for each week). Significant or sudden changes in lead impedance may indicate a problem with the lead.

If the device is unable to perform automatic lead impedance measurements, gaps are present in the trend graph.

Note: The RV Defib impedance is measured and displayed for the currently programmed defibrillation pathway only. Reprogramming the Active Can/SVC Coil parameter changes the electrodes included in the defibrillation pathway and affects which of the collected measurements are displayed in the trend graph.

3.4.2.1 How to view lead impedance trends

To access lead impedance trends, select the Lead Impedance [>>] button or Sensing [>>] button on the Battery and Lead Measurements screen, or select Data > Device/Lead Diagnostics > Lead Impedance Trends > [Open Data].

Figure 28. Lead Trends screen showing the RV Pacing Impedance trend

1 Selected measurement trend 2 Selected pacing polarity 3 Weekly minimum, maximum, and average

values

4 Most recently measured values 5 Last measured impedance value 6 Select [Print…] to print a Lead Trends Report

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3.4.3 Viewing sensing amplitude trends

Every day at 02:15, the device begins to measure the amplitude of intrinsic sensed events. The device attempts to measure the amplitude of 9 normal intrinsic sensed events, and then records the median value from those events. If the device has not collected 9 amplitude measurements by 00:00, no measurement is recorded. The sensing amplitude trend graph shows a gap for that day.

The daily automatic sensing amplitude measurements are displayed on the Lead Trends screen, which plots the data as a graph. The graph displays up to 15 of the most recent measurements and up to 80 weekly summary measurements (showing minimum, maximum, and average values for each week). Significant or sudden changes in sensing amplitude may indicate a problem with a lead.

Note: The sensing amplitude trend data is intended to show changes in sensing amplitude measurements that may be used to assess lead integrity. The adequacy of the ventricular sensing safety margin cannot be determined by the R-wave trend measurement and should be based on VF induction testing.

3.4.3.1 How to view sensing amplitude trends

To access sensing amplitude trends, select the Wave Amplitude [>>] button on the Quick Look II screen, or select Data > Device/Lead Diagnostics > P/R Wave Amplitude Trends > [Open Data].

Figure 29. Lead Trends screen showing the R-wave Amplitude trend

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1 Selected measurement trend 2 Selected amplitude measurement type 3 Weekly minimum, maximum, and average

values

4 Most recently measured values 5 Last automatic daily measurement 6 Select [Print…] to print a Lead Trends Report

3.5 Cardiac Compass Trends

An analysis of clinical information collected over a long term can help you to follow changes in a patient’s condition and correlate these changes with variations in device programming, medication, patient activity, or symptoms.

Cardiac Compass Trends provides a picture of the patient’s condition over the last 14 months. Graphs show trends in the frequency of arrhythmias, the amount of physical activity, heart rates, and device therapies. Dates and event annotations allow you to correlate trends from different graphs. The trends can also help you to assess whether device therapies or antiarrhythmic drugs are effective.

The Cardiac Compass trends are based on data and measurements collected daily. Data storage for Cardiac Compass trends is automatic. No setup is required. The device begins storing data after the device is implanted. Each day thereafter, the device stores a set of Cardiac Compass trend data. Storage continues until the 14-month storage capacity is filled. At that point, the oldest stored data is overwritten with new data.

Notes:

●

The time annotations displayed in the trends are based on the device clock.

●

You cannot manually clear the Cardiac Compass trend data.

3.5.1 How to view and print Cardiac Compass Trends

Cardiac Compass trend data is available on the Cardiac Compass Trends programmer screen and in a printed report. To view Cardiac Compass Trends on the programmer screen, select the Cardiac Compass [>>] button on the Quick Look II screen, or select Data > Clinical Diagnostics > Cardiac Compass Trends > [Open Data]. To print Cardiac Compass Trends, select the [Print…] button if you are already viewing Cardiac Compass Trends on the programmer screen, or select Reports > Available Reports…> Cardiac Compass Trends.

3.5.2 Information provided by Cardiac Compass Trends

Cardiac Compass Trends shows events that have occurred during the reporting period. It also provides trend graphs that can help you to assess the frequency of VT/VF arrhythmias, AT/AF arrhythmias, pacing and rate response, and information related to heart failure.

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3.5.2.1 Event information

Figure 30. Event annotations

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1 Current session indicator 2 Last session indicator

3 High-voltage therapy indicator

Programming and interrogation events – Cardiac Compass Trends shows when the device was interrogated or programmed to allow possible correlations between device parameter changes and other clinical trends.

When the patient is evaluated during an office visit, the report records an “I” for a day on which the device is interrogated and a “P” for a day on which any programmable parameter is changed (except for temporary changes). If the device is interrogated and programmed on the same day, only a “P” is displayed.

When the patient is evaluated during a Medtronic patient monitor session, the report records an “I” with a line beneath it.

Two vertical lines run through all the graphs to indicate the beginning of the current session and the beginning of the last session, if applicable.

One or more shocks per day – Cardiac Compass Trends indicates a shock for any day on which the device delivered a high-voltage therapy (an automatic defibrillation therapy, cardioversion therapy, or atrial shock therapy). Each annotation indicates delivery of one or more ventricular (V) or atrial (A) high-voltage therapies on a single day.

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3.5.2.2 Assessing VT/VF arrhythmia information

Figure 31. VT/VF arrhythmia trend graphs

Treated VT/VF episodes per day – The history of ventricular tachyarrhythmias may be

helpful in revealing correlations between clusters of episodes and other clinical trends.

Each day, the device records the total number of spontaneous VT and VF episodes for which a therapy was started. This count may include therapies that were started and aborted. It does not include episodes that were only monitored.

Ventricular rate during VT/VF – This trend may provide an indication of the effects of antiarrhythmic drugs on VT and VF rates and gives a better understanding of the safety margins for detection.

The graph displays the median ventricular rate during spontaneous VT and VF episodes. Multiple points on one day represent multiple episodes with different median rates. The horizontal lines indicate the programmed VF, VT, and FVT detection rates, if applicable.

Non-sustained VT episodes per day – This trend may help you to correlate patient symptoms (such as palpitations) to non-sustained VT episodes and may indicate a need for further investigation of the status of the patient.

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3.5.2.3 Assessing AT/AF arrhythmia information

Figure 32. AT/AF arrhythmia trend graphs

AT/AF total hours per day – This trend may help you to assess the need to adjust the

patient’s device or drug-based therapies. This trend may also reveal the presence of asymptomatic episodes of AT/AF.

The device records a daily total for the time the patient spent in atrial arrhythmia. The time in AT/AF is calculated from the point of AT/AF Onset. This trend may be reported in hours (0 to

24) or minutes (0 to 60) per day depending on the maximum duration per day. For more information, see Section 5.1, “AT/AF detection”, page 200.

Ventricular rate during AT/AF – You can use this trend to perform the following assessments:

●

Correlate patient symptoms to rapid ventricular responses to AT/AF.

●

Assess VT/VF detection safety margins and modify programming to avoid treating rapidly conducted AT/AF as VT/VF.

●

Prescribe or titrate antiarrhythmic and rate control drugs.

●

Assess the efficacy of an AV node ablation procedure.

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The graph plots average ventricular rates during episodes of atrial arrhythmia each day. The vertical lines show the difference between the average rate and the maximum sensed ventricular rate each day. The horizontal lines indicate the programmed VF, VT, and FVT detection rates, if applicable.

3.5.2.4 Assessing pacing and rate response information

Figure 33. Pacing and rate response trend graphs

Percent pacing per day – This trend provides a view of pacing over time that can help you

to identify pacing changes and trends. The graph displays the percentage of all events occurring during each day that are atrial paces and ventricular paces. The percentages are calculated from the daily counts of AS-VS, AS-VP, AP-VS, and AP-VP event sequences. Atrial refractory events are excluded.

Average ventricular rate – The day and night heart rates provide information that may have the following clinical uses:

●

Objective data to correlate with patient symptoms

●

Indications of autonomic dysfunction or symptoms of heart failure

●

Information regarding diurnal variations

For this trend, “day” is defined as the 12-hour period between 08:00 and 20:00 and “night” as the 4-hour period between 00:00 and 04:00 (as indicated by the device clock).

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Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

1.1 Introduction

Table 1. How to navigate to VF therapies parameters

1.1.1 Product literature

1.1.2 Technical support

1.1.3 Notice

1.2 Primo MRI/Mirro MRI SureScan ICD feature model matrix

Table 2. Product feature relationship

2 Conducting a patient session with the programmer

2.1 Establishing telemetry between the device and the programmer

2.1.1 Using Conexus wireless telemetry

2.1.1.1 How to activate wireless telemetry

Figure 1. Wireless telemetry icon on the task bar

2.1.1.2 Conexus wireless timer operation

2.1.1.3 How to maintain reliable telemetry

2.1.1.4 Session inactivity safeguards

2.1.1.5 Device standby mode

2.1.1.6 Managing wireless telemetry session duration

2.1.1.7 How to maintain patient safety and privacy

2.1.2 Using nonwireless telemetry

2.1.2.1 How to establish nonwireless telemetry

Figure 2. Programming head icon on the task bar

2.2 Starting and ending a patient session

2.2.1 How to start a patient session using wireless telemetry

2.2.2 How to start a patient session using nonwireless telemetry

2.2.3 Device and telemetry effects during a patient session

2.2.4 How to interrogate the device during the session

2.2.5 How to end a patient session

2.3 Display screen features

Figure 3. Main elements of a display screen

2.3.1 Task bar

Figure 4. Task bar display

2.3.2 Status bar

Figure 5. Status bar display

2.3.3 Live Rhythm Monitor window

2.3.4 Task area

Figure 6. Task area of the screen

2.3.5 Tool palette

Table 3. Tool palette options

2.3.6 Buttons

Figure 7. Display screen buttons

2.3.7 Command bar

Figure 8. Command bar

2.4 Delivering an emergency tachyarrhythmia therapy

2.4.1 Considerations for emergency tachyarrhythmia therapies

2.4.2 How to deliver an emergency tachyarrhythmia therapy

2.5 Enabling emergency VVI pacing

2.5.1 Considerations for emergency VVI pacing

2.5.2 How to enable emergency VVI pacing

2.6 Suspending and resuming tachyarrhythmia detection

2.6.1 Considerations for suspending detection

2.6.2 How to suspend or resume detection with the programmer

Figure 9. [Suspend] and [Resume] buttons

2.6.3 How to suspend or resume detection with a magnet

2.7 Monitoring cardiac activity with the Live Rhythm Monitor

2.7.1 Types of live waveform traces

2.7.1.1 Leadless ECG (LECG) waveform

2.7.1.2 ECG waveforms

2.7.1.3 EGM waveforms

2.7.2 Viewing live waveform traces

2.7.2.1 How to select and adjust the waveforms

2.7.2.2 How to change the appearance of the waveform

2.7.2.3 How to interpret Marker Channel annotations and symbols

Figure 10. Pacing Marker Channel annotations and symbols

Figure 11. Atrial detection and therapies Marker Channel annotations and symbols

Figure 12. Ventricular detection and therapies Marker Channel annotations and symbols

2.7.3 Recording live waveform traces

2.7.4 Freezing live waveform traces

Figure 13. Interpreting the frozen strip viewing window

2.7.5 Recalling waveform strips

2.7.5.1 How to recall a waveform strip

2.8 Navigating a patient session with Checklist

2.8.1 How to use a standard checklist

2.8.2 How to create and use a custom checklist

2.9 Programming device parameters

2.9.1 Understanding the symbols used on the Parameters screen