EVERA MRI™ SURESCAN™ DR
Family of MR Conditional digital dual-chamber 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.
EVERA MRI™ SURESCAN™ DR
Reference Manual
A reference manual for the Medtronic Evera MRI SureScan DR family of digital dual-chamber
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, Capture Management, Cardiac Compass, CareAlert,
CareLink, ChargeSaver, Conexus, Evera, Evera MRI, Export, Flashback, Integrity, Intrinsic,
Marker Channel, Marquis, Medtronic, Medtronic CareAlert, Medtronic CareLink, MVP,
OptiVol, Paceart, PR Logic, Quick Look, Reactive ATP, SessionSync, SureScan, Switchback,
T-Shock, TherapyGuide
Medtronic
EVERA MRI™ SURESCAN™ DR
Contents
1 Introduction .......................................................... 8
1.1 Introduction ......................................................... 8
1.2 Evera MRI SureScan DR 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 ............................................. 71
3.1 Quick Look II summary data .......................................... 71
3.2 Medtronic CareAlert events and notifications ............................ 75
3.3 RV Lead Integrity Alert ............................................... 84
3.4 Device and lead performance data .................................... 91
3.5 OptiVol 2.0 fluid status monitoring .................................... 100
3.6 Cardiac Compass Trends ........................................... 105
3.7 Heart Failure Management Report .................................... 111
3.8 Arrhythmia Episodes data ........................................... 118
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3.9 Episode and therapy counters ....................................... 128
3.10 Flashback Memory data ............................................ 133
3.11 Rate Drop Response episodes ....................................... 134
3.12 Rate Histograms ................................................... 137
3.13 Automatic device status monitoring ................................... 139
4 Pacing features ..................................................... 143
4.1 Sensing .......................................................... 143
4.2 Basic pacing ...................................................... 153
4.3 Managed Ventricular Pacing (MVP) ................................... 163
4.4 Rate Response .................................................... 170
4.5 Capture Management .............................................. 177
4.6 Rate Adaptive AV .................................................. 188
4.7 Auto PVARP ...................................................... 190
4.8 Rate Drop Response ............................................... 192
4.9 Rate Hysteresis .................................................... 198
4.10 Sleep feature ...................................................... 200
4.11 Non-Competitive Atrial Pacing ....................................... 201
4.12 PMT Intervention .................................................. 203
4.13 PVC Response .................................................... 204
4.14 Ventricular Safety Pacing ............................................ 206
4.15 Mode Switch ...................................................... 208
4.16 Conducted AF Response ........................................... 211
4.17 Atrial Rate Stabilization ............................................. 213
4.18 Atrial Preference Pacing ............................................ 216
4.19 Post-Mode Switch Overdrive Pacing .................................. 220
4.20 Post Shock Pacing ................................................. 223
4.21 Post VT/VF Shock Overdrive Pacing .................................. 224
4.22 Ventricular Rate Stabilization ........................................ 225
EVERA MRI™ SURESCAN™ DR
5 Tachyarrhythmia detection features .................................. 228
5.1 AT/AF detection ................................................... 228
5.2 VT/VF detection ................................................... 234
5.3 PR Logic .......................................................... 249
5.4 Wavelet .......................................................... 253
5.5 Onset ............................................................ 260
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5.6 Stability ........................................................... 266
5.7 High Rate Timeout ................................................. 268
5.8 TWave Discrimination .............................................. 270
5.9 RV Lead Noise Discrimination ....................................... 274
6 Tachyarrhythmia therapy features ................................... 279
6.1 Atrial therapy scheduling ............................................ 279
6.2 Atrial ATP therapies ................................................ 286
6.3 Atrial cardioversion ................................................. 296
6.4 Patient-activated atrial cardioversion .................................. 302
6.5 VF therapies ...................................................... 307
6.6 Ventricular ATP therapies ........................................... 317
6.7 Ventricular cardioversion ............................................ 327
6.8 Progressive Episode Therapies ...................................... 336
7 System test and EP Study features .................................. 338
7.1 Underlying Rhythm Test ............................................. 338
7.2 Pacing Threshold Test .............................................. 339
7.3 Wavelet Test ...................................................... 341
7.4 Lead Impedance Test ............................................... 344
7.5 Sensing Test ...................................................... 345
7.6 Charge/Dump Test ................................................. 347
7.7 Arrhythmia inductions with EP Studies ................................ 348
7.8 Manual therapies with EP Studies .................................... 356
EVERA MRI™ SURESCAN™ DR
Glossary ................................................................ 359
Index ................................................................... 370
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EVERA MRI™ SURESCAN™ DR
1 Introduction
1.1 Introduction
This manual describes the operation and intended use of features offered by Medtronic
Evera MRI SureScan DR 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 DR 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:
●
Read the product literature for information about prescribing, implanting, and using the
device and conducting a patient follow-up session.
●
Thoroughly read the technical manuals for the leads used with the device. Also read the
technical manuals for other system components.
●
Discuss the device and implant procedure with the patient and any other interested
parties, and 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 Evera MRI SureScan DR ICD feature model matrix
Feature availability for each device model is marked with an “X” in the corresponding column.
Table 2. Product feature relationship
Evera MRI XT DR
SureScan
Features
Optivol 2.0 fluid status monitoring X
Heart Failure Management Report X
DDMB1D4
DDMB1D1
Evera MRI S DR SureScan
DDMC3D4
DDMC3D1
Note: All other features described in this manual apply to all Evera MRI SureScan DR 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)
●
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.
1
1
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.
EVERA MRI™ SURESCAN™ DR
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.
●
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.
●
Shorten the distance between the programmer and the patient.
●
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.
●
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].
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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.
EVERA MRI™ SURESCAN™ DR
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
EVERA MRI™ SURESCAN™ DR
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.
EVERA MRI™ SURESCAN™ DR
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.
EVERA MRI™ SURESCAN™ DR
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].
EVERA MRI™ SURESCAN™ DR
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.
EVERA MRI™ SURESCAN™ DR
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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