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.
11.5 End the analyzer session .................................................................................. 24
4
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.
5
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
6
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
SymbolDescription
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.
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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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.
AreaDescription
1Status bar — Displays status information about the device man-
ager components and the analyzer session. The status bar also
displays the EMERGENCY button.
2Live Rhythm Monitor — Displays real-time waveforms from the
cables connected to the base.
3Work area — Displays parameters, fields, and controls for the
current window.
4Navigation — Displays the menu.
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2.2 Buttons
ButtonDescription
Opens the help.
Generates a PDF report.
Expands and collapses menus and windows.
Note: The arrows are shown in various sizes and with various
background colors. For example, blue and gray background colors.
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
IndicatorDescription
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.
Table 2. Patient connector status indicators
IndicatorDescription
The patient connector battery is good.
The patient connector is charging.
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.
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Table 3. Tablet status indicators
IndicatorDescription
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
IndicatorDescription
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
IndicatorDescription
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 interference.
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.
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 Emergency VVI pacing
3.1 About emergency VVI pacing
In emergency situations, the emergency feature delivers VVI pacing.
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Warning: During a loss of communication in the system, the emergency VVI cannot be performed. Use external pacing support or
defibrillation equipment to provide appropriate therapy to the patient.
Table 6. Emergency VVI pacing parameters
Parameter nameValue
Pacing ModeVVI
Pacing Rate70 bpm
V. Amplitude8.0 V
V. Pulse Width1.5 ms
Sensitivity2.8 mV
Emergency values are settings that provide higher-than-normal energy output. The analyzer is not intended to be left at these settings
indefinitely.
3.2 Enable emergency VVI pacing
To quickly enable high-output ventricular pacing, program emergency VVI pacing.
Warning: During a loss of communication in the system, the emergency VVI cannot be performed. Use external pacing support or
defibrillation equipment to provide appropriate therapy to the patient.
1. Tap EMERGENCY.
2. Review the preset VVI parameters for emergency pacing.
3. Tap PROGRAM.
The analyzer delivers emergency VVI pacing and the EMERGENCY PROGRAM - SUCCESSFUL window appears.
4. Check the patient connection. That is, ensure that the patient or surgical cable is connected to the cardiac device leads.
5. Close the EMERGENCY PROGRAM - SUCCESSFUL window.
6. When the emergency is resolved, tap EXIT EMERGENCY to close the EMERGENCY - VVI PACING screen.
7. Reprogram the analyzer settings to values appropriate for the patient’s needs.
4 Pacing operation descriptions
4.1 Single chamber modes
In the single chamber asynchronous modes, AOO and VOO, the analyzer paces at the Lower Rate regardless of intrinsic activity.
In the single chamber demand modes, AAI and VVI, the analyzer inhibits the next scheduled pacing pulse when an intrinsic event is
sensed before the next scheduled pacing pulse. If no intrinsic event is sensed before the next scheduled pacing pulse, a pacing pulse
is delivered.
4.2 Dual chamber modes
In DDD mode, the analyzer responds to rate increases in the atrium, and provides AV sequential pacing. If no atrial or ventricular
intrinsic events are sensed, the analyzer paces the atrium at the selected Lower Rate and paces the ventricle at the selected or
automatic AV Interval. Intrinsic activity in the atrium and ventricle inhibits the delivery of pacing pulses and restarts timers. An UpperRate is set to prevent the ventricle from being paced too fast.
In DDI mode, sensed atrial events are not tracked. When an atrial event is sensed, atrial pacing is inhibited and ventricular pacing is
delivered at the Lower Rate. If the current pacing interval ends before the device senses an atrial event, the device paces the atrium,
then schedules a ventricular paced event to occur at the end of the AV Interval. If a ventricular sensed event occurs during the AVinterval, ventricular pacing is inhibited. A sensed atrial event that occurs during PVARP is classified as refractory and does not inhibit
atrial pacing.
The DOO mode provides AV sequential pacing at the programmed Lower Rate and paces the ventricle at the selected or automaticAV Interval, with no inhibition by intrinsic events.
The ODO mode does not deliver ventricular or atrial pacing, regardless of the intrinsic rate. The ODO mode is intended only for those
situations in which bradycardia pacing is not necessary.
4.3 Safety pacing
The analyzer is designed to ensure that ventricular pacing is not inhibited in the presence of ambient noise or muscle artifact.
When a ventricular sensed event is detected within 110 ms after an atrial paced event, the analyzer delivers a ventricular output pulse
at one of the following intervals:
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• When the AV Interval is set to less than 110 ms, the analyzer delivers a ventricular output pulse at the end of the AV interval.
• When the AV Interval is set to 110 ms or more, the analyzer delivers a ventricular output pulse at the end of 110 ms.
4.4 PVC response
A premature ventricular contraction (PVC) is defined as a ventricular paced or sensed event followed by a ventricular sensed event,
without an intervening atrial event.
When a PVC is detected and the PVARP is less than 400 ms, the analyzer restarts the VA interval and extends PVARP to 400 ms.
When a refractory sensed atrial event precedes the PVC, PVARP is not extended.
4.5 Reversion
The analyzer is designed to ensure that pacing cannot be continuously inhibited as a result of noncardiac noise, such as noise caused
by muscle stimulation or electromagnetic interference. When noncardiac noise is continuously detected, the device reverts to
asynchronous pacing at the Lower Rate.
5 Using the Live Rhythm Monitor
5.1 About the Live Rhythm Monitor
5.1.1 Live Rhythm Monitor
Use the Live Rhythm Monitor to view waveform traces, view markers, freeze waveform traces, and access waveform strips.
By default, the Live Rhythm Monitor appears in partial-screen view.
5.1.2 Markers
Markers on the waveform trace indicate events such as pacing or sensing.
Markers that indicate atrial events appear above the waveform trace. Markers that indicate ventricular events appear below the
waveform trace.
Table 7. Pacing markers
MarkerDescription
Atrial pace
Atrial sense
Atrial refractory sense
Ventricular pace
Ventricular sense
Ventricular refractory sense
Marker buffer full
5.2 Adjust the Live Rhythm Monitor display
Change the size, color, order, and presentation of waveforms.
Warning: Do not use the analyzer ECG display for diagnosis. Use a separate ECG device if diagnostic ECG capabilities are required.
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 .
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• To change the color of the waveform trace, tap and select a color, then close the window.
• To turn EGM High Gain ON or OFF, or to select the Range of the EGM High Gain, tap and select a value, then close the
window.
Note: EGM High Gain is available only on atrial and ventricular EGM waveform traces.
3. Configure the following additional adjustment options:
OptionDescription
ClippingWhen ON, truncates the tops and bottoms of waveforms that
have high amplitudes.
ECG FilterWhen ON, can improve the clarity of the ECG in the presence
of interference.
ArtifactsWhen ON, displays line boundaries at the beginning and end
of each wave. This feature is also known as pacing artifact
enhancement.
Sweep SpeedAllows 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.
NORMALIZEAdjusts the size of all displayed waveform traces to their max-
imum size without clipping or overlapping.
CALIBRATEAdds a reference signal to the waveform trace of ECG.
OKCloses the adjustment options.
4. To minimize the Live Rhythm Monitor, tap .
5.3 Freeze live waveform traces
To capture a waveform strip and to generate a report, complete the following actions:
1. From the Live Rhythm Monitor, tap
2. To modify the waveform strip, use the options on the FROZEN STRIP window.
3. To generate a report of the waveform strip, complete the following actions:
a. Tap the PDF button.
b. Select the strips that you want to include in the report.
c. Tap GENERATE REPORT > OK.
.
5.4 View single complex waveforms
To closely analyze sensing performance or intracardiac activity, and to view the current of injury, view a single complex waveform.
Caution: Only one complex waveform from one chamber is visible at any one time in this view.
Note: At high rates, not all complex waveforms are shown.
1. To view a single complex waveform, tap .
When the FILTER checkbox is cleared and Pacing is OFF, the fields above the waveform show the following:
• Rate
• Chamber that is displayed
• Filter state
• Peak-to-peak amplitude
2. To closely analyze the single complex waveform, tap the following options.
OptionDescription
A. EGMDisplays the atrial EGM.
V. EGMDisplays the ventricular EGM.
FILTERWhen selected, displays a filtered view of a single complex
waveform. The Sensitivity setting is shown to provide a graphical representation of the sensing margin.
3. Choose the appropriate action:
• To save a report from the single complex waveform, tap , then tap the PDF button.
• To close the single complex monitor, tap .
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6 Using the eStrip recorder
6.1 About the eStrip recorder
You can view waveform strips, add and modify waveform strips, and generate reports of waveform strips using the eStrip recorder.
To open the eStrip recorder, tap
traces ( ) from the Live Rhythm Monitor.
When you open the eStrip recorder, the FROZEN STRIP window appears and displays the last 30 min of all waveform traces from the
Live Rhythm Monitor. You can scroll the view of waveform traces, or you can quickly navigate along a waveform trace by using the
Holter feature. Highlights on the waveform traces indicate waveform strips.
Waveform strips are available to view for the duration of the patient session, including strips that are older than 30 min. To view the
waveform strips, use the strips list or the Holter feature.
6.2 Modify the display of waveform traces
Modify the display of waveform traces using the following options from the FROZEN STRIP window:
• To change the sweep speed for the waveform traces, tap on the sweep speed list and select a value.
For example, when you select 12.5 mm/s, the waveform trace appears narrow. When you select 200.0 mm/s, the waveform trace
appears wide.
• To change the waveform source, tap on the waveform source list and select a source.
• To increase the size of the displayed waveform trace, tap . This option decreases the mV/mm value.
• To decrease the size of the displayed waveform trace, tap . This option increases the mV/mm value.
6.3 Configure waveform strip preferences
To set clipping and artifacts options, or to set the default duration for new waveform strip highlights, configure waveform strip
preferences:
1. From the FROZEN STRIP window, tap
2. Use the following options:
OptionDescription
ClippingWhen ON, truncates the tops and bottoms of waveforms that
Show ArtifactsWhen ON, displays line boundaries at the beginning and end
HIGHLIGHT DURATIONAllows you to set the default duration for all new waveform strip
3. To save your preferences, tap OK.
and then tap ESTRIP RECORDER. You can also open the eStrip recorder by freezing live waveform
.
have high amplitudes.
of each wave. This feature is also known as pacing artifact
enhancement.
highlights.
6.4 Access waveform strips
View, modify, and generate reports of waveform strips:
1. Open the FROZEN STRIP window.
2. To view waveform strips, do one of the following:
• To select a waveform strip, tap STRIPS, then tap a waveform strip from the list. The list displays the STRIP TITLE, TIME,DURATION, and NOTES associated with the waveform strip. The NOTES field displays or when the waveform strip
includes a pinned caliper measurement or annotation.
• To view the previous or next waveform strip, tap or .
3. To add or remove a waveform strip, do either of the following:
• To add a waveform strip, tap the following button:
• To remove a waveform strip, tap the following button:
Note: You cannot remove test strips or any strips that were automatically generated when you started the session.
4. To modify the waveform strip, use the options on the FROZEN STRIP window.
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5. To generate a report of the waveform strip, complete the following actions:
a. Tap the PDF button.
b. Select the strips you want to include in the report.
c. Tap GENERATE REPORT > OK.
6.5 Change the length of a waveform strip
To change the length of a waveform strip, complete the following actions.
Note: You cannot change the length of test strips or any strips that were automatically generated when you started the session.
1. Open the FROZEN STRIP window.
2. Select a strip.
3. Drag the vertical border of the waveform strip to make it longer or shorter.
If you want to move the waveform strip, drag the horizontal border to the right or left.
6.6 Measure time intervals
To measure time intervals on the waveform strip, use the caliper tool:
1. From the FROZEN STRIP window, tap
2. Use the following options:
• To adjust the caliper, drag .
• To walk the caliper, tap .
• To pin the caliper and include the caliper measurement in a strip report that you generate, tap .
• To undo or redo a pinned caliper, tap or .
To close the caliper tool, tap .
.
6.7 Draw notes
To annotate the waveform strip, draw notes on the waveform strip. If you generate a report of the strip, the notes that you draw on the
waveform strip are included in the report.
1. From the FROZEN STRIP window, tap
2. Draw on the waveform strip.
3. Optionally, tap and to remove or reinsert drawings.
To disable the drawing mode, tap .
.
6.8 Rename a waveform strip
To rename a waveform strip, complete the following actions.
Note: You cannot rename test strips or any strips that were automatically generated when you started the session.
1. Open the FROZEN STRIP window.
2. To select the waveform strip, tap its green header.
3. To edit the name, tap the green header and enter a new name.
6.9 Use the Holter feature
To navigate quickly along a waveform trace, use the Holter feature:
1. Open the FROZEN STRIP window.
2. To select the waveform trace that you want to view, tap
3. Tap HOLTER.
The blue rectangle indicates the section of the waveform trace that is displayed in the FROZEN STRIP window. A green rectangle
indicates a waveform strip.
4. Use the following options:
• To navigate along the waveform trace, tap and .
• Tap an area of the waveform trace to display that area in the FROZEN STRIP window.
on the top waveform source list and select a source.
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7 Lead analysis
7.1 About lead analysis
During the implant process, use the analyzer to determine if the lead is positioned appropriately.
Caution: The analyzer provides pacing support during the execution of tests. For pacing-dependent patients, ensure that the Lead
Analysis settings provide appropriate pacing before starting the threshold test or Rapid Atrial Stimulation.
7.2 Start the lead analysis
To start the lead analysis, connect the cables and configure the options.
1. Connect the cables:
Note: For information on setup, configuration, and connection of the cables and base, refer to the base technical manual.
a. Connect the surgical cable, patient cable, or adaptor with compatible cables to the base.
b. Connect the implanted lead to the cable.
2. Configure the lead analysis options:
a. Tap
b. To note the automatic beat-to-beat sensing values for P-wave and R-wave, use the lead analysis options in the work area.
c. To configure additional lead analysis options, use the options in the work area or tap SETTINGS to access the ANALYZER
Table 8. Lead analysis options
OptionDescription
ModeCurrent pacing mode.
Lower RateLowest rate at which pacing occurs during a mode’s basic oper-
A. AmplitudeAllows you to enter the voltage at which a pacing pulse is deliv-
V. AmplitudeAllows you to enter the voltage at which a pacing pulse is deliv-
PacingAllows you to toggle the current pacing mode for the selected
SensingDisplays the sensing value.
ImpedanceDisplays the impedance measurement. Tap to refresh the value.
ThresholdOpens a threshold test.
SETTINGSOpens the ANALYZER SETTINGS window.
VIEW SAVEDOpens the SAVED MEASURES window. On the SAVED MEAS-
SAVEThe SAVE button for A. LEAD opens the SAVE - ATRIAL LEAD
, then tap ANALYZER > LEAD ANALYSIS.
SETTINGS window.
Note: The default value is ODO.
ations.
Lower Rate values above or equal to the Upper Rate are not
selectable when pacing in the DDI or DDD mode. Increase the
Upper Rate to increase the range of selectable Lower Rate
values.
Note: The default value is 70 bpm.
ered to the atrium.
Note: The default value is 5.0 V.
ered to the ventricle.
Note: The default value is 5.0 V.
chamber.
Note: The default value is OFF.
On the ANALYZER SETTINGS window, you can select and
adjust additional pacing parameters, such as pulse width, upper
rate, sensitivity, and AV interval.
URES window, you can export data, save to a report, or clear
saved measurements.
MEASURES window.
The SAVE button for V. LEAD opens the SAVE - VENTRICULARLEAD MEASURES window.
From these windows, you can save measurements.
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Table 9. Analyzer Settings options
OptionDescription
R-Wave FilterAllows you to enter the R-Wave Filter setting used for sensing.
Note: The default value is Default.
AV IntervalAllows you to enter the time between the occurrence of an atrial
event and the scheduled ventricular pacing pulse.
The AV Interval is automatically adjusted based on the selected
Lower Rate and Upper Rate.
Note: The default value is 150 ms.
Upper RateAllows you to enter the maximum rate at which the ventricle can
be paced in response to sensed atrial events in the DDD mode.
Upper Rate values below or equal to the Lower Rate value are
selectable. When selected, you get a message detailing the conflicting parameters. To increase the range of valid Upper Rate
values, decrease the Lower Rate.
Note: The default value is 120 bpm.
A. PolarityOpens the ATRIAL POLARITY window, where you can select the
atrial lead polarity.
If you are using the Model 2292 cable, Model 5103 adaptor, or
Model 5104 adaptor, use an indifferent electrode when connecting unipolar leads to the analyzer.
Note: The default value is Bipolar.
V. PolarityOpens the VENTRICULAR POLARITY window, where you can
select the ventricular lead polarity.
If you are using the Model 2292 cable, Model 5103 adaptor, or
Model 5104 adaptor, use an indifferent electrode when connecting unipolar leads to the analyzer.
Note: The default value is Bipolar.
A. Pulse WidthThe A. Pulse Width parameter specifies the duration of the atrial
pacing pulse.
Note: The default value is 0.4 ms.
V. Pulse WidthAllows you to enter the duration of the ventricular pacing pulse.
Note: The default value is 0.4 ms.
A. SensitivityAllows you to enter the minimum amplitude of electrical activity in
the atrium to which the device is responsive.
Note: The default value is 0.45 mV.
V. SensitivityAllows you to enter the minimum amplitude of electrical activity in
the ventricle to which the device is responsive.
Note: The default value is 2.0 mV.
A. RefractoryAllows you to enter the period following a paced or sensed event
in the atrium during which a sensed event does not restart the
timing for the next scheduled pacing pulse.
This setting adjusts the length of the atrial-channel refractory
period that follows an atrial or ventricular event, whether the event
is sensed or paced.
Note: The default value is 310 ms.
7.3 Select the pacing mode
7.3.1 Select and adjust the pacing mode
Select the appropriate pacing mode for the patient.
On the LEAD ANALYSIS screen, there are 2 methods you can use to change the pacing mode:
• The Pacing fields
• The Mode field
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To change the pacing mode, tap the Mode field. To turn pacing on or off for a lead, tap the corresponding Pacing field. When the
pacing settings change, the analyzer immediately starts or stops pacing.
The Pacing fields are disabled when you select the following pacing modes:
• AOO
• VOO
• DOO
To enable the Pacing fields, use the Mode field to select the following pacing modes:
• ODO
• AAI
• DDI
• VVI
• DDD
To ensure pacing, adjust the Lower Rate and Amplitude.
7.3.2 Mode transition rules
A warning message is displayed on the screen if the following events occur. Follow the directions on the message to resolve the issue.
• There is a conflict in any settings as a result of changing pacing modes (for example, the Lower Rate is set higher than the UpperRate).
• The settings would result in unexpected behavior (for example, 2:1 block).
During mode transitions, all applicable settings in effect in the previous pacing mode are carried over to the new pacing mode.
Settings not defined by the previous pacing mode are set to default settings in the new pacing mode.
7.3.3 Pacing field selectable modes
On the LEAD ANALYSIS screen, toggling between Pacing settings automatically selects Mode settings.
Impedance measurements are made without delivering pacing pulses that capture the heart. The analyzer makes these
measurements by using low-voltage subthreshold pulses.
1. On the LEAD ANALYSIS screen, tap the Pacing field to turn pacing ON for the lead.
The impedance measurement is displayed in the Impedance field.
2. To update the impedance measurement, tap Impedance.
7.5 Determine stimulation thresholds
Determine the stimulation thresholds for patient leads and perform a diaphragmatic stimulation test.
Caution: Throughout the procedure, monitor the patient blood pressure and ECG.
Note: If communication between the pacing system analyzer (PSA) application and the analyzer hardware within the base is paused
or lost during a pacing threshold or diaphragmatic stimulation test, the test stops. The analyzer hardware reverts to pre-test settings,
and pacing continues if the analyzer hardware was programmed to provide pacing support.
1. From the LEAD ANALYSIS screen, confirm that Pacing for the lead you want to test is ON.
2. Tap Threshold for the lead.
3. Confirm that the Lower Rate is 10 bpm above the patient intrinsic rate.
To change the value, tap the Lower Rate field.
4. To determine the pacing threshold, use the following options:
• To change the test amplitude in whole-volt increments, tap 1 V, 2 V, 3 V, 4 V, or 5 V.
• To increase the test amplitude 1 V at a time, up to 8 V, tap .
• To gradually increase or decrease the test amplitude and find the precise threshold, tap +0.125 V or −0.125 V.
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Observe the Live Rhythm Monitor for loss of capture. The pacing threshold is the minimum amplitude at which capture is
consistently maintained.
5. To perform a diaphragmatic stimulation test, press and hold MAXIMUM AMPLITUDE PRESS AND HOLD.
Note: If diaphragmatic stimulation is found after the implant procedure, a lead revision will be needed.
6. Determine the action to take:
Note: The threshold value can only be printed if it is saved.
• To save the threshold and close the window, tap SAVE AS THRESHOLD.
• To close the window without saving the threshold, tap EXIT TEST.
7.6 Save lead measurements
To generate a Saved Lead Measures Report after a lead analysis, save the lead measurement information.
1. From the LEAD ANALYSIS screen, tap SAVE.
Save the measurements for each lead separately.
2. Tap the Lead field and select a value.
If you select LV, select the appropriate polarity value in the Polarity field.
3. Tap SAVE.
4. Tap VIEW SAVED.
5. On the SAVED MEASURES window, enter the patient name in the Patient field.
6. Select the set of measurements, then tap the PDF button.
7. On the REPORT SAVED window, tap OK.
The lead measurements are saved to the Saved Lead Measures Report in SAVED REPORTS.
7.7 Export the lead measurements
Export the saved lead measurements from the analyzer session onto the IMPLANT window of a patient session.
1. Start a patient session if you have not already done so, then return to the concurrent analyzer session.
2. Perform the lead measurements.
3. Save the atrial and ventricular lead measures.
4. From the LEAD ANALYSIS screen, tap VIEW SAVED.
5. On the SAVED MEASURES window, select the set of measurements, then tap EXPORT DATA.
The DATA EXPORTED window appears. The lead measurements are exported to the fields within the IMPLANT window in the
patient session.
6. Tap CLOSE.
For information on programming the lead measurements, see the implantable device app help.
8 Rapid atrial stimulation
8.1 Deliver rapid atrial stimulation
Rapid atrial stimulation delivers high-rate atrial pacing, up to 500 bpm, for the acute conversion of atrial tachyarrhythmias (except atrial
fibrillation).
Warnings:
• Rapid stimulation is intended for use in the atrium only.
• Use of high rates in the atrium could result in high-rate conduction to the ventricle.
• Have defibrillation equipment readily available during rapid atrial stimulation.
Caution: The analyzer provides pacing support during the execution of tests. For pacing-dependent patients, ensure that the Lead
Analysis settings provide appropriate pacing before starting the threshold test and Rapid Atrial Stimulation.
Notes:
• The analyzer provides backup VVI pacing when enabled during rapid atrial stimulation.
• If communication between the pacing system analyzer (PSA) application and the analyzer hardware within the base is paused or
lost during rapid atrial stimulation, the delivery of rapid atrial stimulation stops. The analyzer hardware reverts to pre-test settings,
and pacing continues if the analyzer hardware was programmed to provide pacing support.
1. Tap
2. To turn ventricular pacing ON or OFF, tap the Backup VVI Pacing field.
, then tap ANALYZER > RAPID ATRIAL STIMULATION.
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If the present pacing mode provides ventricular pacing, the default setting is ON.
3. In the DELIVERY VALUES column, modify the values you want to test.
The current values are displayed in the PRESENT VALUES column.
4. To select an atrial delivery rate, tap the Delivery Rate field.
5. To initiate rapid atrial stimulation, tap and release START AOO DELIVERY.Caution: START AOO DELIVERY is not a press and hold button.
6. To change the rate during delivery, use the increase or decrease buttons next to Delivery Rate.Note: The rate increases and decreases in increments of 10, 20, and 50 bpm.
7. To end rapid atrial stimulation, tap STOP DELIVERY.
9 Analyzer reports
9.1 About analyzer reports
Create reports that document the information you gather during analyzer sessions.
All analyzer reports contain the following information:
• Patient name
• Date of visit
• Pacing System Analyzer label
• The serial number of the connected base
9.2 Create analyzer reports
9.2.1 Create the Saved Lead Measures Report
The Saved Lead Measures Report displays data about leads, polarity, time, sensing, impedance, and thresholds.
1. On the LEAD ANALYSIS screen, perform the lead measurements.
2. Under the A. Lead or V. Lead column, tap SAVE.
3. Tap the Lead field and select a value. If necessary, tap the Polarity field and select a value.
4. Tap SAVE.
5. On the LEAD ANALYSIS screen, tap VIEW SAVED.
6. On the SAVED MEASURES window, select the set of measures, then tap the PDF button.
9.2.2 Create the Strip Chart Report
The Strip Chart Report is a single report that represents waveform strips.
1. Tap , then tap ESTRIP RECORDER.
2. Tap the PDF button.
9.2.3 Create single complex waveform reports
The Frozen A. EGM and Frozen V. EGM reports (referred to as the single complex waveform reports) show a strip chart, an annotation
area, and the chart speed and time of collection. The Frozen A. EGM report displays atrial data. The Frozen V. EGM report displays
ventricular data.
1. From the single complex waveform monitor, tap the A. EGM or V. EGM button.
2. Tap FILTER to turn the filter on or off.
3. Tap .
4. Tap the PDF button.
9.3 View or export saved reports and implantable device data
When you generate a report or save implantable device data during a session, the report or data is saved to the SAVED REPORTS
window. From the SAVED REPORTS window, you can view or export the reports and data. The export options depend on the email,
network, and printing apps or connections set up on your tablet.
1. Tap
2. On the SAVED REPORTS window, view reports or export reports and device data:
, then tap SAVED REPORTS / DATA.
• To view a report, tap VIEW next to the report.
• To export reports, select the reports, tap SEND TO…, then select the export option or location.
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• To export device data and the reports associated with the device data, select the PKG file, tap SEND TO…, then select the
export option or location.
Notes:
• To select all files, tap the checkbox in the upper left corner.
• When you select multiple reports to export, the reports export as a single PDF file.
Note: You are responsible for the management of patient and device data that you export from SAVED REPORTS. Examples of
patient and device data include printed paper reports, data transferred to a hospital network, and emailed attachments.
10 Measurement parameters
10.1 Measurement parameter values
All measurements and accuracies assume a noise-free environment.
Ventricular blanking after
ventricular sense
(SVVB)
Ventricular blanking after
ventricular pace (PVVB)
120 ms+2/−30 ms120 msAtrial and ventricular
blanking intervals are
nonprogrammable.
Blanking tolerances are
based on a 1 ms sine
input twice the minimum
amplitude at which sensing occurs.
200 ms+5/−30 ms200 msAtrial and ventricular
blanking intervals are
nonprogrammable.
Blanking tolerances are
based on a 1 ms sine
input twice the minimum
amplitude at which sensing occurs.
11 Working with sessions
11.1 Connect to a patient connector
To export lead measurements into a patient session, connect to a patient connector from the analyzer.
1. Verify that the patient connector is disconnected from any previously connected device manager app.
2. To turn on the Bluetooth wireless technology, press the grey button on the patient connector.
When the Bluetooth wireless technology is active, the Bluetooth light on the patient connector is on.
3. On the status bar, tap .
4. Tap CONNECT in the patient connector connection area.
5. Tap CONTINUE.
6. From the device manager app, follow the prompts to connect to the patient connector. For more information, refer to the device
manager app help.
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11.2 Start a concurrent patient session
To adjust the programmable parameters and evaluate the performance of an implanted device, start a concurrent patient session.
1. Ensure that the following requirements are met:
• The previous patient session has ended.
• The base and patient connector are connected to the analyzer.
• The patient connector is positioned directly over or is within range of the implanted device.
2. Tap
To return to the analyzer from the patient session, tap , then tap ANALYZER.
To return to the concurrent patient session from the analyzer, tap , then tap the name of the implantable device.
, then tap INTERROGATE.
11.3 View the SessionSync connection status
If your clinic uses a Paceart Optima system, the SessionSync feature enables you to transfer saved implantable device data and
reports to that system.
To view the SessionSync connection status, use the DATA SYNCHRONIZATION STATUS window.
Notes:
• The SessionSync connection status is only visible if you configure the SessionSync feature. To configure the SessionSync
feature, refer to the device manager app help.
• The Paceart Optima system is only available in supported regions.
1. On the status bar, tap
2. From DATA EXPORT STATUS, tap DETAILS….
.
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3. On the DATA SYNCHRONIZATION STATUS window, view the SessionSync connection status:
• Available – The SessionSync feature is enabled and there is a connection between the device manager app and the Paceart
Optima system.
• Disconnected – The SessionSync feature is enabled, but the tablet is disconnected from the network.
• Not Available – The SessionSync feature is enabled, but the connection to the Paceart Optima system is unavailable.
The DATA SYNCHRONIZATION STATUS window also shows the following information.
FieldDescription
Clinic NameName of the clinic that receives SessionSync transfers.
Gateway addressIP address or hostname of the SessionSync gateway.
TransfersThe implantable device data and reports that the SessionSync feature transfers to
the Paceart Optima system. The Transfers table displays the most recent transfer
at the top of the table.
• GENERATED – Date and time of the transfer
• RECEIVING CLINIC – Name of the clinic that receives the transfer
• STATUS – Status of the transfer
11.4 Troubleshoot connectivity issues
During a session, the analyzer can lose the ability to communicate with the base.
If the analyzer loses the ability to communicate with the base, the analyzer and base respond in the following ways:
• The analyzer displays a message.
• The analyzer stops any in-progress tests.
• The analyzer pacing returns to the programmed pacing values.
• The LED on the side of the base flashes, which indicates two things:
– The base is still providing pacing (when programmed to pace).
– Communication between the analyzer and base was lost.
Warning: During procedures, have backup pacing and defibrillation readily available.
To troubleshoot connectivity issues, complete the following:
• To close the message and return to the analyzer test screen, tap CLOSE.
• Verify both that the base is turned on and that Bluetooth is enabled on the tablet.
• Move the tablet closer to the base and move the system away from anything else that causes interference.
• To determine when connectivity is restored, watch the LED indicators on the base and the status indicators at the top of the screen.
If connectivity is not restored, restart the session.
11.5 End the analyzer session
When your measurements are complete, end the analyzer session.
Note: After 45 min of inactivity, the analyzer displays a message that prompts you to extend or end the session. If you do not respond
to the message and there is 60 min of inactivity, the analyzer session ends automatically.
1. Complete the following actions:
• Generate the reports that you want to keep. When you end the session, any unsaved data is lost.
• Be aware that when you end an analyzer session, all pacing operations stop.
2. Tap , and then tap END SESSION.
3. On the END SESSION? window, tap one of the following buttons:
• END NOW — Ends the session and stops all pacing operations.
• CANCEL — Displays the previous screen without ending the session.
Toll-free in the USA (24-hour technical consultation for physicians and
medical professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636