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Medtronic
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D00U008
Instructions for Use
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Medtronic D00U008 Instructions for Use

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CareLink SmartSync™ Viva™ Consulta™ Syncra™ Advisa™ Ensura™ Application Help for CRT-P devices
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
AdaptivCRT™, Advisa DR MRI™, Advisa SR MRI™, Advisa™, Capture Management™, Cardiac Compass™, CardioSync™, CareLink SmartSync™, CareLink™, Consulta™, Ensura™, OptiVol™, Paceart Optima™, Paceart™, Quick Look™, SessionSync™, SureScan™, Syncra™, Viva™

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Intended use of the implantable device app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Download or order the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 IT network, tablet, and data information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.7 Reporting errors and serious incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Overview of the interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 View the Quick Look screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8 Using emergency VVI pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8.1 Enable emergency VVI pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9 Suspending and resuming tachyarrhythmia detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.1 Suspend and resume tachyarrhythmia detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10 Programming patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.1 Program the patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
11 Programming implantable device settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11.1 Parameter symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11.2 Program the parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
11.3 Create custom parameter sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
11.4 Retrieve parameter sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
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15.2 Start or return to a concurrent analyzer session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
15.3 Save the implantable device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
15.4 About Read From File sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
15.5 End the patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
16 Working with reports and saved device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
16.1 Configure the report preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
16.2 Generate reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
16.3 View or export saved reports and implantable device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
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1 Introduction

1.1 Description

About the implantable device app
The CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (referred to as the implantable device app) allows you to program the settings of the following implantable devices and view stored device data:
Implantable pulse generators (IPG) Cardiac resynchronization therapy pacemakers (CRT-P)
Advisa DR MRI SureScan Viva CRT-P Advisa DR Consulta CRT-P Advisa SR MRI SureScan Syncra CRT-P
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.
Note: The CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application model number is D00U008.
About this app help
This app help applies to use of the implantable device app with CRT-P models only. The features described in this app help apply to the Viva CRT-P Model C6TR01 device. To determine which features are available for another implantable device model, refer to the clinician manual for that device.

1.2 Intended use of the implantable device app

1.2.1 Intended use

The intended purpose is to interrogate, program, or execute tests on a Medtronic cardiac device.

1.2.2 Intended users

The implantable device app is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital environment.

1.2.3 Intended patient population

The implantable device app is intended for use with patients who either have or are receiving a supported implantable device.

1.2.4 Expected clinical benefits

The clinical benefit of the implantable device app is the ability to interrogate and program Medtronic implantable devices and test cardiac leads.

1.2.5 Indications for use

For information about the indications for the implantable devices that are compatible with the implantable device app, refer to the clinician manuals for the implantable devices.

1.2.6 Contraindications

There are no known contraindications for the use of the implantable device app.
Note: For information about contraindications for the implantable devices that are compatible with the implantable device app, refer to the clinician manuals for the implantable devices.

1.3 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 clinician manuals for the implantable devices.
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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.
Improper use of the implantable device app could result in erroneous programming, inadvertent pacing, improper operation of telemetry, or 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, whether the test continues or stops depends on the type of test. For more information, refer to the section on performing system tests in this app 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 and Precautions Manual for Health Care Professionals.

1.4 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 clinician manuals for the implantable devices.

1.5 Download or order the instructions for use

To view, download, print, or order a PDF version of this app help, go to www.medtronic.com/manuals, or contact a Medtronic representative.
The PDF version of this app help can be viewed using a current version of any major internet browser. For best results, use Adobe™* Acrobat™* Reader software with the browser.
Paper copies of this app help are available to customers free of charge. They should arrive in 3 to 7 days. To order, go to www.medtronic.com/manuals or contact a Medtronic representative.

1.6 IT network, tablet, and data information

1.6.1 Required IT network characteristics and configuration

To use the implantable device app, your tablet must have Bluetooth® wireless technology1. An Internet connection is optional.
Bluetooth wireless technology
You must enable Bluetooth wireless technology on your tablet. The Bluetooth connection allows the hardware components of the device manager to communicate with the device manager app that is installed on the tablet.
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 access to an information technology (IT) network (for example, a Wi-Fi™* or cellular network) results in the inability to export and print reports using a wireless connection.
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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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1.6.2 Supported tablets and technical specifications

The tablet on which the device manager app is installed must meet the requirements in the CareLink SmartSync Tablet Compatibility Technical Manual. To download or order the CareLink SmartSync Tablet Compatibility Technical Manual, go to www.medtronic.com/manuals, or contact a Medtronic representative.
Note: The device manager app may not be compatible with the most current version of the tablet operating system.

1.6.3 Intended information flows

Data from the implantable device flows through the device manager components in the following sequential order:
1. Implantable device
2. Patient connector
3. Implantable device app
All information in transit is protected for security.

1.7 Reporting errors and serious incidents

If a serious incident related to the CareLink SmartSync app occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.
If you find information in this app help that is incorrect, contact a Medtronic representative.

2 Overview of the interface

2.1 Areas

The implantable device app is divided into 3 areas:
• The 2 status bars at the top of the screen display status information about the device manager components and the patient session. The top status bar also displays the SUSPEND, RESUME, and EMERGENCY buttons, as well as the (Menu) button.
• The Live Rhythm Monitor, which appears below the status bars, displays real-time waveform traces.
• The work area, which is the largest area of the screen, displays the parameters, fields, and controls for the current window.

2.2 Status indicators

The status bar at the top of the screen displays the status of the base, the tablet, the patient connector, and the implantable device.
For more information, tap

Table 1. Base status indicators

Indicator Description

Table 2. Tablet status indicators

Indicator Description
on the status bar.
The base is connected to the device manager app.
The base is connected to the device manager app, and an ana­lyzer 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.
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.
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Table 3. Patient connector status indicators

Indicator Description
The patient connector is connected to the device manager app. The patient connector battery is good.
The patient connector is connected to the device manager app. The patient connector is charging.
The patient connector is connected to the device manager app. The patient connector battery is low.
The patient connector is connected to the device manager app. 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 4. Implantable device status indicators

Indicator Description
The implantable device is connected to the patient connector. The connection is either strong or moderate. To improve the con­nection, move the implantable device and the instruments closer together and away from anything else that causes interference.
The implantable device is connected to the patient connector. The connection 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 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 interference.

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 between the device manager app and the base or the patient connector 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 connection between 2 system components has been lost. Move the 2 system components closer together and away from anything else that causes interference. The device manager attempts to establish the connection and restore communication.
There is a USB connection between the base and the patient connector.
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.
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Table 5. Connection status indicators (continued)
Indicator Description
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 > INTERROGATE.
2. If the INTERROGATE HOW MUCH? window appears, select one of the following options, then tap START:
• 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. The implantable device app displays the status indicator warning in a message window when you interrogate the implantable device. The status indicator warning is also displayed 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 a Medtronic representative.

4.2 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 an OK button, tap OK to close the message.
• If the status indicator warning has a CLEAR button, tap CLEAR to remove the status indicator.
2. Review the arrhythmia episode records and evaluate atrial lead integrity.
3. Adjust therapy parameters as needed.

4.3 Respond to the WARNING – DEVICE ELECTRICAL RESET warning

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. e. Interrogate the implantable device.
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2. Determine the events leading up to the device reset: a. To determine the time and date of the device reset, 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 a 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 automatically paces in VVI mode at 65 bpm until the
parameters are reprogrammed. b. Verify that the implantable device date and time are correct. If necessary, 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.

4.4 Respond to the SERIOUS DEVICE ERROR warning

If the implantable device app displays a SERIOUS DEVICE ERROR status indicator warning, contact a Medtronic representative. Immediate replacement of the device is recommended.
To respond to the SERIOUS DEVICE ERROR status indicator warning, complete the following actions:
1. 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.
2. Tap CONTINUE.
3. To verify that the battery voltage of the implantable device is acceptable, check the BATTERY AND LEAD MEASUREMENTS window.
4. Verify the programmed device parameters and reprogram them as necessary.
Note: The implantable device automatically paces in VVI mode at 65 bpm until the parameters are reprogrammed.

5 Using the Live Rhythm Monitor

5.1 About the Live Rhythm Monitor

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 implanted 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 implanted device can result in missing markers on the waveform trace display.
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
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Table 6. Pacing markers (continued)
Marker Description
Atrial sense in PVAB
Ventricular pace
Ventricular sense
Ventricular refractory sense
Proactive pace
Mode switch
Unrecognized marker
Biventricular pace

Table 7. Detection and therapy markers

Marker Description
AT/AF sense
Fast AT/AF sense
AT/AF detection
Fast AT/AF detection
Fast A&V detection
VT monitor detection
Tachycardia pace

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 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.
3. Configure the following additional adjustment options:
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