Medtronic D00U005 Instructions for Use
CareLink SmartSync™ Cobalt™ Crome™ Application Help
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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.
AdaptivCRT, ATP During Charging, Capture Management, Cardiac Compass, CardioSync, CareAlert, CareLink, CareLink SmartSync, Cobalt, Crome, EffectivCRT,
Medtronic, Medtronic CareAlert, MVP, OptiVol, Paceart, Paceart Optima, Quick Look, SessionSync, SureScan, T-Shock, VectorExpress
Contents
1 Introduction ................................................................................................ 5
1.1 Description ................................................................................................ 5
1.2 About the device manager ................................................................................... 5
1.3 Intended use .............................................................................................. 5
1.4 Contraindications .......................................................................................... 5
1.5 Warnings and precautions ................................................................................... 5
1.6 Potential adverse events .................................................................................... 6
1.7 Download or order the instructions for use ..................................................................... 6
1.8 Symbols .................................................................................................. 6
1.9 IT network, tablet, and data information ........................................................................ 6
2 Overview of the interface ................................................................................... 7
2.1 Areas ..................................................................................................... 7
2.2 Buttons ................................................................................................... 8
2.3 Status indicators ........................................................................................... 8
3 Reinterrogating the implanted device ....................................................................... 10
3.1 Reinterrogate the implanted device .......................................................................... 10
4 Responding to device status indicator warnings ............................................................. 10
4.1 About device status indicator warnings ....................................................................... 10
4.2 Respond to the WARNING – CHARGE CIRCUIT TIMEOUT warning .............................................. 10
4.3 Respond to the WARNING – CHARGE CIRCUIT INACTIVE warning ............................................. 10
4.4 Respond to the AT/AF THERAPIES DISABLED warning ........................................................ 10
4.5 Respond to the WARNING – DEVICE RESET warning .......................................................... 11
5 Using the Live Rhythm Monitor ............................................................................. 11
5.1 About the Live Rhythm Monitor .............................................................................. 11
5.2 Markers .................................................................................................. 11
5.3 Adjust the Live Rhythm Monitor display ....................................................................... 13
5.4 Freeze live waveform traces ................................................................................ 14
6 Using the eStrip recorder .................................................................................. 14
6.1 About the eStrip recorder ................................................................................... 14
6.2 Modify the display of waveform traces ........................................................................ 14
6.3 Configure waveform strip preferences ........................................................................ 14
6.4 Access waveform strips .................................................................................... 14
6.5 Change the length of a waveform strip ........................................................................ 15
6.6 Measure time intervals ..................................................................................... 15
6.7 Draw notes ............................................................................................... 15
6.8 Rename a waveform strip .................................................................................. 15
6.9 Use the Holter feature ...................................................................................... 15
7 Viewing summary data using the Quick Look screen ......................................................... 16
7.1 About the Quick Look screen ............................................................................... 16
7.2 View the Quick Look screen ................................................................................ 16
8 Delivering an emergency tachyarrhythmia therapy ........................................................... 17
8.1 Deliver an emergency tachyarrhythmia therapy ................................................................ 17
9 Using emergency VVI pacing ............................................................................... 17
9.1 Enable emergency VVI pacing .............................................................................. 17
10 Programming patient information ......................................................................... 18
10.1 Program the patient information ............................................................................ 18
10.2 Program MRI SureScan system and other implanted hardware information ....................................... 19
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11 Programming implantable device settings ................................................................. 19
11.1 Parameter symbols ....................................................................................... 19
11.2 Program the parameters .................................................................................. 20
11.3 Create custom parameter sets ............................................................................. 20
11.4 Retrieve parameter sets ................................................................................... 20
11.5 Program data collection preferences ........................................................................ 21
11.6 View parameter changes .................................................................................. 22
11.7 Demonstrate alert tones .................................................................................. 22
12 Viewing and analyzing diagnostic data .................................................................... 22
12.1 View CareAlert and OptiVol events ......................................................................... 22
12.2 View clinical diagnostic data ............................................................................... 23
12.3 View device and lead diagnostic data ....................................................................... 25
13 Performing system tests .................................................................................. 26
13.1 Configure the test preferences for the Live Rhythm Monitor .................................................... 26
13.2 Perform an Underlying Rhythm Test ......................................................................... 26
13.3 Perform a Sensing Test ................................................................................... 27
13.4 Perform a Pacing Threshold Test ........................................................................... 28
13.5 Perform a Lead Impedance Test ............................................................................ 29
13.6 Perform a VectorExpress LV Automated Test (CRT-D devices only) .............................................. 29
13.7 Perform a CardioSync Optimization Test (CRT-D devices only) .................................................. 30
13.8 Perform a Charge/Dump Test .............................................................................. 31
13.9 Perform a Wavelet Test ................................................................................... 31
13.10 Perform EP Study tests to induce arrhythmias ............................................................... 32
13.11 Perform EP Study tests to deliver manual therapies .......................................................... 36
14 Using the SessionSync feature ............................................................................ 37
14.1 View the SessionSync connection status .................................................................... 37
14.2 Send device data and reports to the Paceart Optima system ................................................... 38
14.3 End the patient session with the automatic SessionSync feature ................................................ 38
15 Using session tools ...................................................................................... 38
15.1 Connect to the base ...................................................................................... 38
15.2 Start or return to a concurrent analyzer session ............................................................... 38
15.3 Save the implantable device data ........................................................................... 38
15.4 About Read From File sessions ............................................................................ 39
15.5 End the patient session ................................................................................... 39
16 Working with reports and saved device data ............................................................... 39
16.1 Configure the report preferences ........................................................................... 39
16.2 Generate reports ......................................................................................... 39
16.3 View or export saved reports and implantable device data ..................................................... 40
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1 Introduction
1.1 Description
The CareLink SmartSync Cobalt Crome Application (referred to as the implantable device app) communicates with Cobalt XT, Cobalt,
and Crome MRI SureScan implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D).
The implantable device app allows you to program the device settings and view stored device data.
Use the implantable device app to perform the following tasks:
• Review the presenting rhythm
• Verify the status of the implantable device
• Assess the clinical effectiveness of the implantable device
• View or enter patient information
• Program parameters
• Save or export data
The implantable device app is a component of the CareLink SmartSync device manager.
Unless otherwise noted, the features described in this help apply to the Cobalt XT HF Quad CRT-D MRI SureScan devices. To
determine which features are available for another model in the Cobalt XT, Cobalt, or Crome MRI SureScan families, refer to the
reference manual for the device.
Note: The CareLink SmartSync Cobalt Crome Application model number is D00U005.
1.2 About the device manager
The CareLink SmartSync device manager includes the following components:
• CareLink SmartSync Model 24970A base (referred to as the base)
• Model 24967 patient connector (referred to as the patient connector)
• CareLink SmartSync Device Manager Application (referred to as the device manager app)
The device manager app is the primary interface of the device manager. The device manager app provides access to the implantable
device app and the CareLink SmartSync PSA (Pacing System Analyzer) Application (referred to as the analyzer).
1.3 Intended use
The implantable device app is intended to be used as part of the device manager. Clinicians use the implantable device app with the
patient connector to adjust programmable parameters and evaluate the performance of implantable Cobalt XT, Cobalt, and Crome
systems.
The implantable device app is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital
environment.
For information about indications for the implantable devices that are compatible with the implantable device app, refer to the device
manual.
1.4 Contraindications
There are no known contraindications for the use of the implantable device app.
For information about contraindications for the implantable devices that are compatible with the implantable device app, refer to the
device manual.
1.5 Warnings and precautions
These warnings and precautions apply when using the implantable device app in combination with the other device manager
components.
Note: For warnings and precautions about the use of the implantable devices that are compatible with the implantable device app,
refer to the device manual.
Electrical and patient safety – The device manager is compliant with the requirements of IEC 60601-1 for electrical and patient
safety.
Importance of instructions for use – Before using the implantable device app, Medtronic recommends that you do the following:
• Read the implantable device instructions for use.
• Read the device manager instructions for use.
• Carefully assess the patient’s condition and the implantable device system to determine the appropriate settings for tests and
device programming.
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Improper use of the implantable device app could result in erroneous programming, inadvertent pacing, improper operation of
telemetry, and incorrect operation of measurement functions.
Tablet and app interaction – Due to the dynamic nature of the tablet environment, operating system events such as notifications,
alarms, and messaging can take priority and therefore move the implantable device app to the background. Tapping, pressing buttons,
and using gestures on the tablet can also result in moving the implantable device app to the background or closing the implantable
device app. For example, the implantable device app moves to the background if you lock the tablet.
When the implantable device app moves to the background or closes, telemetry with the implantable device is paused or lost, which
results in the following scenarios:
• If detection has been suspended and there is no magnet present, the implantable device resumes detection within a few seconds.
• If a test is in progress, the test stops or continues, depending on the type of test. For more information, refer to the section on
performing system tests in this help.
When you restore the implantable device app from the background, the implantable device app attempts to re-establish
communication with the implantable device and displays the system status. If the implantable device app was closed, you must
interrogate the implantable device to re-establish communication with the implantable device.
Electromagnetic interference – If electromagnetic interference (EMI) occurs during a telemetry session, EMI can prevent the
proper programming or confirmation of values. For more information about EMI, refer to the Medical Procedure and EMI Warnings,
Precautions, and Guidance Manual for Health Care Professionals.
1.6 Potential adverse events
There are no known potential adverse events related to the use of this implantable device app.
For information about potential adverse events related to the use of the implantable devices that are compatible with the implantable
device app, refer to the device manual.
1.7 Download or order the instructions for use
Download or order the instructions for use from the Medtronic Manual Library.
To download the instructions for use, go to www.medtronic.com/manuals. For best results, use Adobe Acrobat® Reader.
To order paper copies of the instructions for use, go to www.medtronic.com/manuals or contact a Medtronic representative. Paper
copies of the instructions for use are free of charge and arrive in approximately 3 to 7 days.
1.8 Symbols
Symbol Description
Manufacturer
Authorized representative in the European Community
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician
1.9 IT network, tablet, and data information
1.9.1 Required IT network characteristics and configuration
To use the implantable device app, your tablet must have Bluetooth® wireless technology1. A connection to the Internet is optional.
Bluetooth wireless technology
You must enable Bluetooth wireless technology on your tablet. The hardware components of the device manager communicate with
the device manager app, installed on the tablet, through a Bluetooth connection.
Failure to provide Bluetooth communication access prevents the device manager components from communicating with each other
and with implantable devices. As a result, the device manager app is unable to establish a Bluetooth connection with the patient
connector. The patient connector is used to interrogate and program the implantable cardiac device.
Internet
To configure your network, follow the processes and policies of your organization.
Internet access is not required to export and print reports. However, failure to provide information technology (IT) network access (for
example, Wi-Fi or cellular) results in the inability to export and print reports using a wireless connection.
1
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. Any use of the word mark by Medtronic is under license.
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1.9.2 Supported tablets and technical specifications
To use the device manager, your tablet must meet certain requirements.
Note: The device manager app may not be compatible with the most current version of the tablet operating system.
For more information on the requirements, refer to the CareLink SmartSync Tablet Compatibility Technical Manual. To download or
order the CareLink SmartSync Tablet Compatibility Technical Manual, go to medtronic.com/manuals.
1.9.3 Intended information flows
Data from the implantable device flows through the device manager components in the following sequential order:
• Implantable device
• Patient connector
• Implantable device app
All information in transit is protected for security.
2 Overview of the interface
2.1 Areas
The implantable device app is divided into 4 areas.
Area Description
1 Status bar – Displays status information about the device man-
ager components and the patient session. The status bar also
displays the SUSPEND, RESUME, and EMERGENCY buttons.
2 Live Rhythm Monitor – Displays real-time waveform traces.
3 Work area – Displays the parameters, fields, and controls for the
current window.
4 Navigation – Displays the menu.
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2.2 Buttons
Button Description
Opens the help
Generates a PDF report
Expands or collapses a menu or window
Note: The arrows are shown in various sizes and background
colors, such as blue and grey.
Reverses the change
SUSPEND Temporarily suspends the tachyarrhythmia detection within the
implantable device
RESUME Resumes the tachyarrhythmia detection within the implantable
device
EMERGENCY Opens a window that enables you to provide emergency tachyar-
rhythmia therapy or emergency VVI pacing
2.3 Status indicators
The status bar displays the status of the base, the patient connector, the tablet, and the implantable device.
For more information, tap on the status bar.
Table 1. Base status indicators Indicator Description
The base is connected to the device manager app.
The base is connected to the device manager app, and an ana-
lyzer session is in progress.
There is no base connected to the device manager app.
Note: A green dot indicates that a base was recently connected
to the device manager app, but is not connected now.
Table 2. Patient connector status indicators Indicator Description
The patient connector battery is good.
The patient connector is charging.
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Table 2. Patient connector status indicators (continued)
Indicator Description
The patient connector battery is low.
The patient connector battery is critically low.
There is no patient connector connected to the device manager
app.
Note: A green dot indicates that a patient connector was recently
connected to the device manager app, but is not connected now.
Table 3. Tablet status indicators Indicator Description
The tablet is connected to an IT network.
Note: The status indicator shows the remaining percentage of
the tablet battery.
The tablet is not connected to an IT network.
Note: The status indicator shows the remaining percentage of
the tablet battery.
Table 4. Implantable device status indicators Indicator Description
The implantable device is connected to the patient connector
using low-frequency inductive telemetry. The connection is either
strong or moderate.
The implantable device is connected to the patient connector
using Bluetooth wireless technology. The connection is either
strong or moderate.
The implantable device is connected to the patient connector
using low-frequency inductive telemetry. The connection is weak.
The implantable device is connected to the patient connector
using Bluetooth wireless technology. The connection is weak.
The connection with the implantable device has been lost.
Table 5. Connection status indicators Indicator Description
The Bluetooth connection between the device manager app and
the base or the patient connector is strong.
The Bluetooth connection is moderate.
To improve the connection, move the tablet closer to the base or
the patient connector and away from anything else that causes
interference.
The Bluetooth connection has been lost.
The device manager attempts to establish the connection and
restore communication. Move the tablet closer to the base or the
patient connector and away from anything else that causes inter-
ference.
There is a USB connection between the base and the patient
connector.
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Table 5. Connection status indicators (continued)
Indicator Description
The connection with the implantable device is weak.
To improve the connection, move the implantable device and the
instruments closer together and away from anything else that
causes interference.
The connection with the implantable device is moderate.
To improve the connection, move the implantable device and the
instruments closer together and away from anything else that
causes interference.
The connection with the implantable device is strong.
3 Reinterrogating the implanted device
3.1 Reinterrogate the implanted device
During a device implant or a patient follow-up appointment, you can reinterrogate the implanted device.
Note: For information on how to perform an initial interrogation, refer to the device manager app help.
1. Tap
2. If the INTERROGATE HOW MUCH? window appears, select one of the following options, then tap START:
, then tap INTERROGATE.
• To display all of the information stored on the implanted device, tap All.
• To display only the information stored on the implanted device since the last patient session, tap Since Last Session.
4 Responding to device status indicator warnings
4.1 About device status indicator warnings
The implantable device automatically monitors for internal conditions that affect implantable device operation and require attention.
If any such conditions occur, the implantable device saves the status indicator to its memory, and the implantable device app displays
the status indicator warning when you interrogate the implantable device.
The implantable device app displays the status indicator warning in a message window and in the OBSERVATIONS area on the Quick
Look screen.
Caution: If the implantable device app displays a status indicator warning for the implantable device, contact your Medtronic
representative.
4.2 Respond to the WARNING – CHARGE CIRCUIT TIMEOUT warning
If the implantable device app displays a CHARGE CIRCUIT TIMEOUT warning, inform a Medtronic representative. An immediate
device replacement is recommended.
The CHARGE CIRCUIT TIMEOUT warning indicates that the charging period has exceeded 27 s. The charge circuit is still active.
4.3 Respond to the WARNING – CHARGE CIRCUIT INACTIVE warning
If the implantable device app displays a CHARGE CIRCUIT INACTIVE warning, inform a Medtronic representative. An immediate
device replacement is recommended.
The CHARGE CIRCUIT INACTIVE warning indicates that 3 consecutive charging periods have each exceeded 36 s. The charge
circuit is inactive and all automatic therapy functions, EP study functions, and manual system tests are disabled except for Emergency
VVI pacing.
4.4 Respond to the AT/AF THERAPIES DISABLED warning
Respond to the AT/AF THERAPIES DISABLED status indicator warning for the implantable device:
1. Complete one of the following actions:
• If the status indicator warning has a CLEAR button, tap CLEAR to remove the status indicator.
• If the status indicator warning has an OK button, tap OK to close the message.
2. Review the arrhythmia episode records and evaluate atrial lead integrity.
3. Adjust therapy parameters as needed.
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4.5 Respond to the WARNING – DEVICE RESET warning
To respond to the WARNING – DEVICE RESET status indicator warning, use the information in this topic.
If the device is not yet implanted, do not implant the device. Contact a Medtronic representative.
A device reset is a safety feature that can automatically change parameter values or clear diagnostic data in response to a problem
with the implantable device memory. If a device status indicator warning for a reset appears, you must clear the device status indicator.
You may need to reprogram the implantable device to the desired parameters.
After a device reset, the device records a status indicator. For a device reset that requires attention, the status indicator warning for
the implantable device describes how the reset affected device data. Read the message accompanying the indicator and follow the
on-screen instructions carefully. If the message indicates that the reset affected implantable device parameters, you must reprogram
the implantable device to restore the previous settings.
1. Respond to the status indicator warning:
a. Remove any sources of electromagnetic interference (EMI).
b. Notify a Medtronic representative.
c. To clear the status indicator, tap CLEAR in the window.
A confirmation window appears, indicating that all previously interrogated data in the implantable device app will be cleared.
d. Tap CONTINUE.
Note: If a device reset occurred while the MRI SureScan parameter was programmed to On, the MRI SureScan window
appears. Program the MRI SureScan parameter to Off before continuing with the next step.
e. Interrogate the implantable device.
2. Determine the events leading up to the device reset:
a. To determine the time and date of the device reset, view the CareAlert EVENTS log.
Note: If the implantable device does not have a CareAlert EVENTS log, note the time and date when counter data was last
cleared.
b. If the device is implanted, determine what the patient was doing at the time and date of the device reset.
c. Save the implantable device data.
d. Send the implantable device data to your Medtronic representative.
3. Reprogram the implantable device:
a. Verify the programmed device parameters and reprogram them as necessary.
Note: If the reset affected the parameters, the implantable device operates with values that provide basic device functionality
until the parameters are reprogrammed. Basic device functionality includes pacing in VVI mode at 65 bpm and, in some
cases, disabled tachyarrhythmia detection and therapy.
b. Verify that the implantable device date and time are correct. If necessary, a Medtronic representative can reprogram the date
and time.
c. To verify that the battery voltage of the implantable device is acceptable, check the BATTERY AND LEAD
MEASUREMENTS window.
d. Conduct lead impedance and pacing threshold tests as desired.
5 Using the Live Rhythm Monitor
5.1 About the Live Rhythm Monitor
The Live Rhythm Monitor displays markers and telemetered EGM waveform traces from the implanted device. If the device manager
app is connected to the base, the Live Rhythm Monitor displays ECG waveform traces from the base.
During patient sessions, you can view live waveform traces, freeze waveform traces, and access waveform strips.
In addition to waveform traces, the Live Rhythm Monitor displays the following information:
• The current heart rate and interval measured by the implantable device
• Annotations above the waveform trace showing when programming occurred (if parameters have been programmed)
The display of waveform traces in the Live Rhythm Monitor varies, depending on the EGM sources that you select during data
collection setup.
5.2 Markers
Markers on the waveform trace indicate events such as pacing, sensing, detection, and delivered therapies.
Note: Any interruption in telemetry with the implantable device can result in missing markers on the waveform trace display.
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Markers that indicate atrial events appear above the waveform trace. Markers that indicate ventricular events appear below the
waveform trace.
Table 6. Pacing markers Marker Description
Atrial pace
Atrial sense
Atrial refractory sense
Atrial sense in PVAB
Ventricular pace
Ventricular sense
Ventricular refractory sense
Proactive pace
Mode switch
Marker buffer full
Biventricular pace
Table 7. Atrial detection and therapy markers Marker Description
AT/AF sense
Fast AT/AF sense
AT/AF detection
Fast AT/AF detection
Atrial tachycardia pace
Cardioversion pulse
Charge end
Table 8. Ventricular detection and therapy markers Marker Description
VT sense
FVT sense via VT
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Table 8. Ventricular detection and therapy markers (continued)
Marker Description
FVT sense via VF
VF sense
VT detection
FVT detection
VF detection
VT monitor detection
Ventricular tachycardia pace
Charge end
Cardioversion/defibrillation pulse
5.3 Adjust the Live Rhythm Monitor display
To change the size, order, and presentation of waveforms, complete the following actions:
1. To expand the Live Rhythm Monitor, tap .
2. To see all available waveform traces, scroll vertically.
3. To change the size, color, and order of the waveform traces, complete the following actions:
• To change the waveform source, tap on the waveform source list and select a source.
• To decrease the size of the displayed waveform trace, tap .
• To adjust the size of the displayed waveform trace to its maximum size without clipping or overlapping other waveform traces,
tap .
• To increase the size of the displayed waveform trace, tap .
• To change the color of the waveform trace, tap and select a color, then close the window.
4. Configure the following additional adjustment options:
Option Description
Clipping When ON, truncates the tops and bottoms of waveforms that
have high amplitudes.
ECG Filter When ON, can improve the clarity of the ECG in the presence
of interference.
Artifacts When ON, displays line boundaries at the beginning and end
of each wave. This feature is also known as pacing artifact
enhancement.
Sweep Speed Allows you to select a sweep speed for the waveform traces.
For example, when you select 12.5 mm/s, the waveform trace
appears narrow. When you select 100.0 mm/s, the waveform
trace appears wide.
NORMALIZE Adjusts the size of all displayed waveform traces to their max-
imum size without clipping or overlapping.
CALIBRATE Adds a reference signal to the waveform trace of ECG.
OK Closes the adjustment options.
5. To minimize the Live Rhythm Monitor, tap .
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