CareLink SmartSync™ PSA 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.
CareLink, CareLink SmartSync, Medtronic, Paceart, Paceart Optima, SessionSync
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 Download or order the instructions for use ..................................................................... 7
1.7 Symbols .................................................................................................. 7
1.8 IT network, tablet, and data information ........................................................................ 7
2 Overview of the interface ................................................................................... 8
2.1 Areas ..................................................................................................... 8
2.2 Buttons ................................................................................................... 9
2.3 Status indicators ........................................................................................... 9
3 Emergency VVI pacing ..................................................................................... 10
3.1 About emergency VVI pacing ............................................................................... 10
3.2 Enable emergency VVI pacing .............................................................................. 11
4 Pacing operation descriptions .............................................................................. 11
4.1 Single chamber modes .................................................................................... 11
4.2 Dual chamber modes ...................................................................................... 11
4.3 Safety pacing ............................................................................................. 11
4.4 PVC response ............................................................................................ 12
4.5 Reversion ................................................................................................ 12
5 Using the Live Rhythm Monitor ............................................................................. 12
5.1 About the Live Rhythm Monitor .............................................................................. 12
5.2 Adjust the Live Rhythm Monitor display ....................................................................... 12
5.3 Freeze live waveform traces ................................................................................ 13
5.4 View single complex waveforms ............................................................................. 13
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 Lead analysis ............................................................................................. 16
7.1 About lead analysis ........................................................................................ 16
7.2 Start the lead analysis ..................................................................................... 16
7.3 Select the pacing mode .................................................................................... 17
7.4 Measure lead impedance .................................................................................. 18
7.5 Determine stimulation thresholds ............................................................................ 18
7.6 Save lead measurements .................................................................................. 19
7.7 Export the lead measurements .............................................................................. 19
8 Rapid atrial stimulation .................................................................................... 19
8.1 Deliver rapid atrial stimulation ............................................................................... 19
9 Analyzer reports .......................................................................................... 20
9.1 About analyzer reports ..................................................................................... 20
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9.2 Create analyzer reports .................................................................................... 20
9.3 View or export saved reports and implantable device data ....................................................... 20
10 Measurement parameters ................................................................................. 21
10.1 Measurement parameter values ............................................................................ 21
10.2 Pacing parameter values .................................................................................. 21
11 Working with sessions .................................................................................... 23
11.1 Connect to a patient connector ............................................................................. 23
11.2 Start a concurrent patient session .......................................................................... 23
11.3 View the SessionSync connection status .................................................................... 23
11.4 Troubleshoot connectivity issues ........................................................................... 24
11.5 End the analyzer session .................................................................................. 24
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1 Introduction
1.1 Description
The CareLink SmartSync PSA (Pacing System Analyzer) Application (referred to as the analyzer) assesses the pacing and sensing
performance of the cardiac lead system during the implant of an implantable cardiac device.
The analyzer provides the following features:
• Dual and single chamber pacing modes
• Automatic measurement of P-wave and R-wave amplitudes
• Lead impedance measurement
• Real-time display of atrial and ventricular EGM and ECG waveforms
• Rapid atrial stimulation to 500 bpm
• Measurement reports
• Ability to save or export data
The analyzer is a component of the CareLink SmartSync device manager.
To display and report on the cardiac lead and ECG data that transmits to the CareLink SmartSync Model 24970A base (referred to as
the base), the analyzer communicates with the hardware that is located in the base. Clinicians use the data to perform these tasks:
• Analyze electrical performance of cardiac leads during implant
• Assess proper placement of cardiac leads during implant
• View, measure, and document live cardiac waveforms
Note: The CareLink SmartSync PSA (Pacing System Analyzer) Application model number is D00U002.
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 apps and to the CareLink SmartSync PSA (Pacing System Analyzer) Application (referred to as the analyzer).
1.3 Intended use
The analyzer is intended to be used as part of the device manager.
Clinicians use the analyzer to evaluate the pacing and sensing performance of a cardiac lead system during the following procedures:
• The implant of a cardiac arrhythmia management device
• Invasive troubleshooting of a cardiac lead system
During these procedures, the analyzer can also be used to provide rapid atrial pacing for the acute conversion of atrial
tachyarrhythmias (except atrial fibrillation).
The analyzer is intended for use by healthcare professionals in operating environments under direct medical supervision.
1.4 Contraindications
Do not use the analyzer as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient’s age and
medical condition may dictate the pacing modes and lead analyses appropriate for the patient.
1.5 Warnings and precautions
These warnings and precautions apply in general when using the analyzer in combination with the device manager components to
assess the electrical performance of cardiac lead systems for implantable heart devices.
Backup pacing and defibrillation – Backup pacing and defibrillation should be readily available during procedures.
Changing polarity settings – Confirm the polarity capabilities of the cardiac lead system before changing polarity settings.
Changing polarity settings could result in loss of pacing if the cardiac lead system is not set up to facilitate pacing in the polarity
selected.
DDD pacing mode – Do not operate the analyzer in the DDD pacing mode when only the ventricular pacing lead is connected.
Interference detected at the unconnected atrial input of the analyzer can result in false sensing and can drive the ventricular pacing
rate to the Upper Rate setting.
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Defibrillation or cardioversion – Whenever possible, for the safety of the patient, disconnect the base from the cardiac lead system
before defibrillating or cardioverting.
Defibrillatory discharges may damage the analyzer hardware in the base when the base is connected to an indwelling cardiac lead
system.
• The analyzer recovers normal operation within 2 seconds in the ventricle and within 6 seconds in the atrium for the defibrillation
test pulse defined in IEC 60601-2-31.
• Test the analyzer after it is exposed to such charges.
Diagnostic ECG – Do not use the ECG display for diagnosis. Use a separate ECG device if diagnostic ECG capabilities are required.
Electrical and patient safety – The device manager is compliant with the requirements of IEC 60601-1 for electrical and patient
safety.
Electrosurgical units (cautery) – Do not use electrosurgical units within 15 cm (6 in) of the cardiac lead system. Electrosurgical units
can cause tachyarrhythmias by inducing current on the leads.
Equipment compatibility – The device manager should be used only for the assessment of implanted cardiac lead systems for
compatible implantable devices from Medtronic. Use of the device manager with implantable devices from other manufacturers may
result in incompatible measurements. Medtronic does not accept responsibility for measurements taken using the device manager
with implantable devices from other manufacturers.
High output and maximum sensitivity – Avoid using high output (high amplitude and wide pulse width) and maximum sensitivity
simultaneously. This combination may result in oversensing intrinsic events, far-field sensing of intrinsic events, or sensing of paced
events. The combination of high output and maximum sensitivity may include the following effects:
• Use of high atrial sensitivity (low numerical settings) may allow ventricular potentials to inappropriately inhibit or trigger the atrial
output in the presence of large ventricular depolarization potentials or high output.
• High output and maximum sensitivity may result in opposite-chamber sensing of the pace output. The analyzer hardware in the
base includes a safety pacing feature to prevent inappropriate inhibition of ventricular pacing due to far-field sensing.
• Use of high sensitivity in the ventricle may result in inappropriate inhibition of the ventricular output due to T-wave or myopotential
sensing.
Importance of instructions for use – Before using the device manager, Medtronic recommends that you take the following actions:
• Read the device manager instructions for use.
• Read the instructions for use for the leads and implantable device.
• Carefully assess the patient condition and the implantable device system to determine the appropriate settings for tests and
device programming.
Improper use of the device manager could result in erroneous programming, inadvertent pacing, improper operation of telemetry, and
incorrect operation of measurement functions.
Magnetic interference – The base includes a magnet under the charge cradle to secure the patient connector and ensure charging.
The symbol on the cradle identifies the location of this magnet. Avoid placing devices or material that may be damaged by the
magnetic field (such as magnetic media, watches, or other electronic devices) on top of the base.
Some tablets may be sensitive to magnetic interference. Keep strong magnetic sources (such as magnetic programming heads,
patient magnets like the Model 9466 Tachy Patient Magnet, or other strong magnetic field generators) away from direct contact with
the tablet when working with the device manager.
Note that the Model 24967 patient connector does not include a magnet and is not a source of magnetic interference.
Measurement function – The analyzer is designed to detect and measure pulse rate, AV interval and pulse width, and implantable
device pace artifacts. The base takes these digital measurements with the assistance of optional skin electrodes that collect ECG
signals. Medtronic makes no claims or warranties as to the effectiveness of this measurement function as a diagnostic tool to the
physician.
Modification of equipment – Do not modify any hardware or software component of the device manager. Modifications may reduce
system effectiveness and impact user or patient safety. Modifying any component without the approval of Medtronic could void the
user’s authority to operate the equipment.
Rapid atrial stimulation – Have defibrillation equipment readily available during rapid atrial stimulation. Use of high rates in the
atrium can result in high-rate conduction to the ventricle. Accidental high-rate stimulation of the ventricles may result in ventricular
tachycardia or fibrillation.
Single complex monitor – If the single complex monitor is selected on the analyzer, connect the patient to a separate ECG monitor
in order to view a continuous ECG. The single complex monitor replaces the continuous waveform monitor on the display, eliminating
your view of complete heart activity.
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 analyzer to the background. Tapping, pressing buttons, and using
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gestures on the tablet can also result in moving the analyzer to the background or closing the analyzer. For example, the analyzer
moves to the background if you lock the tablet.
When the analyzer moves to the background or closes, the analyzer pauses communication or loses communication with the analyzer
hardware within the base. If a test is in progress, the test stops. The analyzer hardware reverts to pre-test settings, and pacing
continues if the analyzer hardware was programmed to provide pacing support.
When you restore the analyzer from the background, the analyzer attempts to re-establish communication with the analyzer hardware
and displays the system status. If the analyzer was closed, you must reconnect the base to the device manager app to re-establish
communication with the analyzer.
Temporary pacing – Do not leave the patient unattended when the analyzer hardware in the base provides external pacing. The
analyzer is a diagnostic device. If prolonged external pacing is needed, move the patient to an external pulse generator.
Termination of pacing – Turn off pacing before you end an analyzer session. If you end an analyzer session with pacing turned on,
all pacing operations stop. Abrupt termination of pacing stimuli may result in intervals of asystole before an intrinsic rhythm is
reestablished.
Before you turn off pacing, set the analyzer to a demand mode (VVI, AAI, DDD, or DDI). Next, gradually reduce the pacing rate below
the patient’s intrinsic rate. Turn off pacing when a spontaneous rhythm is established.
Threshold tests – Carefully consider the patient’s medical condition before performing a threshold test. The following may occur
during a threshold test:
• Asystole may result due to loss of capture.
• Pacing stimuli may be inadvertently delivered within the vulnerable period of the T-wave. This may be hazardous to patients with
acute myocardial infarction or who are otherwise predisposed to arrhythmias.
1.6 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.
1.7 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
1.8 IT network, tablet, and data information
1.8.1 Required IT network characteristics and configuration
To use the analyzer, your tablet must have both 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 analyzer 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.
As a result, the device manager app is unable to establish a Bluetooth connection with the base, which prevents access to the analyzer
and prevents the ability to view ECG waveforms.
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.
1.8.2 Supported tablets and technical specifications
To use the device manager, your tablet must meet certain requirements.
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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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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.
1.8.3 Intended information flows
Implanted cardiac lead data is processed through the device manager components in the following sequential order:
• Implanted cardiac leads
• Base (via cables connected to the leads and to the base)
• Analyzer
All information in transit is protected for security.
2 Overview of the interface
2.1 Areas
The analyzer screen is divided into 4 areas.
Area Description
1 Status bar — Displays status information about the device man-
ager components and the analyzer session. The status bar also
displays the EMERGENCY button.
2 Live Rhythm Monitor — Displays real-time waveforms from the
cables connected to the base.
3 Work area — Displays parameters, fields, and controls for the
current window.
4 Navigation — Displays the menu.
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