Medtronic W3SR01, W2SR01 User Manual
Azure™ S SR MRI SureScan™ W3SR01
MR Conditional single chamber pacemaker with SureScan™ technology and Bluetooth
®
wireless telemetry (OOE-VVIR)
Device Manual
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.
Azure, Capture Management, CareAlert, CareLink, Flashback, Medtronic, Medtronic CareAlert,
Medtronic CareLink, Quick Look, SureScan
Contents
1 System overview 4
1.1 CE mark of conformity 4
1.2 Introduction 4
1.3 System description 4
1.4 Indications and usage 5
1.5 Contraindications 5
1.6 MRI conditions for use 5
1.7 Feature summary 6
1.8 Data security 7
1.9 Pacing mode information 7
2 Warnings, precautions, and potential adverse events 8
2.1 General warnings and precautions 8
2.2 Explant and disposal 8
2.3 Handling and storage instructions 9
2.4 Lead evaluation and lead connection 9
2.5 Device operation 10
2.6 Potential adverse events 11
3 Implant procedure 12
3.1 Preparing for an implant 12
3.2 Selecting and implanting the lead 13
3.3 Testing the lead system 14
3.4 Connecting the lead to the device 14
3.5 Positioning and securing the device 15
3.6 Completing the implant procedure 16
3.7 Replacing a device 17
4 Product specifications 18
4.1 Physical characteristics 18
4.2 Electrical specifications 19
4.3 Replacement indicators 22
4.4 Projected service life 22
5 Device parameters 24
5.1 Emergency settings 24
5.2 Magnet application 24
5.3 Tachyarrhythmia detection parameters 24
5.4 Pacing parameters 25
5.5 Data collection parameters 27
5.6 Medtronic CareAlert parameters 27
5.7 System test parameters 28
5.8 EP study parameters 28
5.9 Nonprogrammable parameters 30
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1 System overview
1.1 CE mark of conformity
2017
1.2 Introduction
This manual describes the Medtronic Model W3SR01 Azure S SR MRI SureScan single chamber, implantable
pulse generator (IPG). It contains model-specific feature information, indications and contraindications, warnings
and precautions, instructions for implanting the device, quick reference specifications, and parameter tables.
Additional manuals and documents with information about the device:
MRI technical manual – This manual provides MRI-specific procedures and warnings and precautions.
Reference manual – This manual contains information about device features. The reference manual applies to
multiple models of IPG devices.
Programming guide – This manual explains how to use the programmer software to conduct a patient session.
Explanation of symbols – This document defines the symbols that may appear on the device package. Refer to
the package label to see which symbols apply specifically to this device.
Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals – This
manual provides warnings, precautions, and guidance for health care professionals who perform medical
therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education
information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments.
Radio regulatory compliance information – This document provides compliance information related to the
radio components of the device.
1.3 System description
The Medtronic Azure S SR MRI SureScan Model W3SR01 single chamber implantable pulse generator (IPG) is
a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single
chamber rate-responsive bradycardia pacing. This device features Bluetooth wireless technology.
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The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely
scanned by an MRI machine while the device continues to provide appropriate pacing. When programmed to On,
MRI SureScan operation disables arrhythmia detection, magnet mode, and all user-defined diagnostics. Before
performing an MRI scan, refer to the MRI technical manual.
Rate response – Rate response is controlled through an activity-based sensor.
The users of this device include medical professionals (physicians, nurses, technicians, and their supporting staff)
trained in surgery, cardiology, radiology, and magnetic resonance (MR) technology and able to implement the
procedures documented in the instructions for use for this device.
1
The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by
Medtronic is under license.
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1.3.1 Usage environments
The device is intended to be used in the following environments and conditions:
●
The device will be implanted in a properly equipped, staffed, and sterile surgical environment. Implant will take
place under standard surgical protocols and in the patient population for which the device is indicated.
●
Post-surgical patient and device follow-up care will take place in a properly equipped and staffed cardiology
clinic or office.
●
MRI procedures for patients with this device will take place in a properly equipped and staffed MR facility, and
in consideration of the conditions and requirements described in Section 1.6, “MRI conditions for use”,
page 5.
●
After having an implant, patients may resume their lives at home, at work, and in other environments with
consideration of the advice and restrictions documented in the Medical Procedure and EMI Warnings and
Precautions Manual for Health Care Professionals.
1.3.2 System components and accessories
Contents of sterile package – The package contains 1 implantable pulse generator (IPG) and 1 torque wrench.
Implantable device system – The Azure S SR MRI SureScan Model W3SR01 device and the pacing lead
constitute the implantable portions of the device system.
Lead – The lead system used with this device must provide sensing and pacing to the right ventricle (RV). Do not
use any lead with this device without first verifying lead and connector compatibility.
For information about selecting and implanting a SureScan lead for this device, refer to Section 3.2, “Selecting and
implanting the lead”, page 13.
Programmers and software – Medtronic programmers and software are used to program this device.
Programmers from other manufacturers are not compatible with Medtronic devices, but they do not damage
Medtronic devices.
Medtronic pacing system analyzer – A pacing system analyzer is used to measure the electrical characteristics
of the implanted lead to assess its effectiveness for pacing and sensing.
Medtronic patient monitor – Patients use the Medtronic patient monitor, if available, to gather information from
their implanted devices and communicate the information to their physicians through the Medtronic CareLink
Network. For information on using the patient monitor, refer to the patient monitor literature.
1.4 Indications and usage
The Azure S SR MRI SureScan system is indicated for use in patients who may benefit from rate responsive or
non-rate responsive pacing to restore physiologic heart rates, improve cardiac output, prevent symptoms, or
protect against arrhythmias related to cardiac impulse formation or conduction disorders.
1.5 Contraindications
The Medtronic Azure S SR MRI SureScan system is contraindicated for the following:
●
Concomitant implantation with another bradycardia device
●
Concomitant implantation with an implantable cardioverter defibrillator (ICD)
●
Rate responsive modes in patients who cannot tolerate pacing rates above the programmed lower rate
●
Asynchronous pacing where spontaneous rhythms may cause competitive pacing
●
Single chamber atrial pacing in patients with an AV conduction disturbance.
1.6 MRI conditions for use
A complete SureScan pacing system is required for use in the MR environment. A complete SureScan
pacing system includes a SureScan device with a Medtronic SureScan lead. Any other combination may
result in a hazard to the patient during an MRI scan.
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Warning: Do not scan a patient without first programming the MRI SureScan mode to On. Scanning the patient
without programming the MRI SureScan mode to On may result in patient harm or damage to the SureScan pacing
system.
Note: The MRI SureScan mode cannot be programmed to On if the device is recommended for replacement.
Cardiology requirements
Patients and their implanted systems must be screened to meet the following requirements:
●
The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
●
The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance
history.
●
The SureScan pacing system is implanted in the left or right pectoral region.
●
The pace polarity parameters are set to Bipolar for programming the MRI SureScan mode to On.
●
The SureScan device is operating within the projected service life.
●
For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan
mode is programmed to On, no diaphragmatic stimulation is present when the paced lead has a pacing output
of 5.0 V and a pulse width of 1.0 ms.
Caution: It is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold
is greater than 2.0 V at 0.4 ms for pacemaker-dependent patients. A higher pacing capture threshold may indicate
an issue with the implanted lead.
Notes:
●
For radiology requirements, refer to the MRI technical manual.
●
Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and
precautions.
Patient monitoring and rescue requirements
●
Continuous patient monitoring is required during the MRI scan.
●
In the event that patient rescue is required, an external defibrillator must be immediately available.
1.7 Feature summary
The following features are available in this device. For a list of the features that are enabled at shipping, see the
“Shipped” column of the tables in Chapter 5, “Device parameters”, page 24.
1.7.1 Pacing features
Auto-adjusting sensitivity – This feature automatically adjusts the sensitivity thresholds after specific paced
events and sensed events occur.
Automatic polarity configuration – This device uses lead impedance measurements to automatically configure
pacing and sensing polarities during Implant Detection.
MRI SureScan – This feature allows patients with an implanted MRI SureScan system, including the device and
lead, to have a safe MRI procedure if the requirements provided in the MRI technical manual are followed.
Rate Profile Optimization – The goal of Rate Profile Optimization is to ensure that the rate response remains
appropriate for the full range of patient activities. This feature monitors the patient’s daily and monthly sensor rate
profiles and adjusts the rate response curves over time to achieve a prescribed target rate profile.
Rate-responsive pacing – This feature varies the pacing rate in response to the patient’s physical motion as
detected by the activity sensor of the device.
RV Capture Management – This feature monitors the right ventricular pacing threshold with daily pacing
threshold searches and, if programmed to do so, adjusts the RV pacing amplitude toward a target amplitude.
Sleep feature – This feature causes the device to pace at a slower rate during a programmed sleep period.
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1.7.2 Monitoring and follow-up features
Episode data and EGM storage – The system provides an arrhythmia episode log that enables you to view the
summary and detailed diagnostic data quickly, including stored EGM, for the selected arrhythmia episode.
Flashback memory – This diagnostic feature records intervals that occur immediately prior to tachyarrhythmia
episodes or the most recent interrogation and plots the interval data over time.
Holter telemetry – This function allows the implanted device to transmit an EGM with marker telemetry
continuously for up to 46 hours, regardless of the use of the programming head.
Implant Detection – Implant Detection is a 30 min period, beginning when the device is placed in the surgical
pocket. During this period, the device verifies lead connection by measuring lead impedance. When the Implant
Detection period is completed, various automatic features and diagnostics are activated.
Lead Monitor – This feature measures lead impedances during the life of the implanted device and controls
automatic configuration of lead polarities at implant. If Lead Monitor is programmed to Adaptive, the device
automatically switches bipolar pacing and sensing to unipolar pacing and sensing if the integrity of a bipolar lead
is compromised.
Medtronic CareAlert Monitoring – If the device identifies any programmed or automatic CareAlert conditions,
this feature sends a wireless alert signal to the patient monitor (if available). The patient monitor then transmits the
CareAlert Event data to the Medtronic CareLink Network. If configured to do so, the Medtronic CareLink Network
then sends an alert notification to the clinic.
Rate Histograms report – This report shows heart rate range distributions for the patient.
1.8 Data security
Medtronic has designed safeguards to protect patient information and device data for the
Azure S SR MRI SureScan Model W3SR01 device.
Bluetooth communication system – The device shows its availability through Bluetooth communication.
Critical data accepted or sent through the Bluetooth communication from the device is encrypted by the device
before it is sent over the Bluetooth channel. The device responds only to authorized commands.
Inductive telemetry communication system – The Medtronic inductive telemetry communication system is
used with the clinician programmer to interrogate and program the device. It can also be used to interrogate the
device for remote monitoring, if available. This system uses short-range communication that protects patient
information and device data.
1.9 Pacing mode information
Pacemaker modes are described using the NBG code. The five-letter NBG code, named after The North American
Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG),
describes the operation of implantable pulse generators. The NBG code, which supersedes the ICHD Code, is
described in Table 1.
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Table 1. The Revised NASPE/BPEG Generic Code for antibradycardia pacing
Position: I II III IV V
Category: Chamber(s)
Paced
Chamber(s)
Sensed
Response to
Sensing
Rate Modulation
Multisite Pacing
a
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
O = None
T = Triggered
I = Inhibited
D = Dual
(T + I)
O = None
R = Rate modulation
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
Manufacturers’
designation
only:
S = Single
b
(A or V)
S = Single
b
(A or V)
a
Medtronic devices do not use the Multisite Pacing code.
b
The programmer displays A or V (not S) for chambers paced and sensed.
2 Warnings, precautions, and potential adverse events
2.1 General warnings and precautions
Before performing an MRI scan, refer to the Medtronic MRI technical manual for MRI-specific warnings
and precautions.
Refer to the Medical Procedure and EMI Warnings and Precautions Manual for information about hazards related
to medical therapies and diagnostic procedures on patients with cardiac devices. This manual also includes
information about sources of EMI in the patient’s environment.
Anti-coagulation – Use of the device should not change the application of established anti-coagulation protocols.
Electrical isolation during implant – Do not allow the patient to have contact with grounded electrical equipment
that might produce electrical current leakage during implant. Electrical current leakage may induce
tachyarrhythmias that may result in the patient’s death.
External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever
tachyarrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant
testing.
Lead compatibility – Do not use another manufacturer’s leads without demonstrated compatibility with
Medtronic devices. If a lead is not compatible with a Medtronic device, the result may be undersensing of cardiac
activity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection.
A complete SureScan pacing system includes a SureScan device connected to a SureScan lead. Before
performing an MRI scan, refer to the Medtronic MRI technical manual for additional information.
2.2 Explant and disposal
Consider the following information related to device explant and disposal:
●
Explant the implantable device postmortem. In some countries, explanting battery-operated implantable
devices is mandatory because of environmental concerns; please check the local regulations. In addition, if
subjected to incineration or cremation temperatures, the device may explode.
●
Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted
devices.
●
Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back
cover for addresses.
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2.3 Handling and storage instructions
Carefully observe these guidelines when handling or storing the device.
2.3.1 Device handling
Checking and opening the package – Before opening the sterile package tray, visually check for any signs of
damage that might invalidate the sterility of the package contents.
If the package is damaged – The device packaging consists of an outer tray and an inner tray. Do not use the
device or accessories if the outer or inner packaging tray is wet, punctured, opened, or damaged. Return the
device to Medtronic because the integrity of the sterile packaging or the device functionality may be compromised.
This device is not intended to be resterilized.
If the package information is damaged – If any information on the outer package or the sterile package is
defaced or damaged so that you cannot read it, notify Medtronic so that the device can be replaced.
If the printed manual is illegible – If this manual is supplied in its printed form and any part of it is illegible, contact
Medtronic to request a replacement manual.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This device is
for single use only and is not intended to be resterilized.
Device temperature – Allow the device to reach room temperature before it is programmed or implanted. Device
temperature above or below room temperature may affect initial device function.
Dropped device – Do not implant the device if it is dropped on a hard surface from a height of 30 cm or more after
it is removed from its packaging.
Fluid immersion – Do not immerse the device in fluid or flush the connector ports at the time of implant. Doing so
could adversely affect the performance of the device and lead system.
“Use by” date – Do not implant the device after the “Use by” date because the battery longevity could be reduced.
For single use only – Do not resterilize and reimplant an explanted device.
2.3.2 Device storage
Avoid magnets – To avoid damaging the device, store the device in a clean area away from magnets, kits
containing magnets, and any sources of electromagnetic interference.
Temperature limits – Store and transport the package between –18°C and +55°C. Device reset may occur at
temperatures below –18°C. Device longevity may decrease and performance may be affected at temperatures
above +55°C.
2.4 Lead evaluation and lead connection
Refer to the lead technical manuals for specific instructions and precautions about lead handling.
A Medtronic MRI SureScan system includes a Medtronic MRI SureScan device connected to a Medtronic MRI
SureScan lead. Before performing an MRI procedure, refer to the Medtronic MRI technical manual for
additional information.
Torque wrench – Use only the torque wrench supplied with the device. The torque wrench is designed to prevent
damage to the device from overtightening a setscrew. Other torque wrenches (for example, a blue-handled or
right-angled hex wrench) have torque capabilities greater than the lead connector can tolerate.
Lead connection – Consider the following information when connecting the lead and the device:
●
Cap abandoned leads to avoid transmitting electrical signals.
●
Verify the lead connection. A loose lead connection may result in inappropriate sensing.
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2.5 Device operation
Lead – A bipolar or unipolar lead may be used with the Azure S SR MRI SureScan Model W3SR01 device, but if
a lead other than bipolar MRI SureScan lead is used, the system is contraindicated for MRI scans.
Accessories – Use this device only with accessories, parts subject to wear, and disposable items that have been
tested to technical standards and found safe by an approved testing agency.
Device status indicators – If any of the device status indicators (for example, Device Reset) are displayed on the
programmer after interrogating the device, inform a Medtronic representative immediately. If these device status
indicators are displayed, therapies may not be available to the patient.
Effects of myopotential sensing in unipolar sensing configurations – In unipolar sensing configurations, the
device may not distinguish myopotentials from cardiac signals. This may result in a loss of pacing due to inhibition.
To address these situations, the device may be programmed to be less sensitive (using higher sensitivity values),
but the sensitivity level must be balanced against the potential to undersense true cardiac signals. Typically, this
balance is easily attained for ventricular sensing using sensitivity values around 2.8 mV.
Device reset – Device reset can be caused by exposure to temperatures below –18°C or strong electromagnetic
fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits to avoid
exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmed mode
with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at 65 min–1.
Device reset is indicated by a programmer warning message that is displayed immediately upon interrogation. To
restore the device to its previous operation, it must be reprogrammed. Inform a Medtronic representative if your
patient’s device has reset.
End of Service (EOS) indicator – Replace the device immediately if the programmer displays an EOS indicator.
The device may soon lose the ability to pace and sense adequately.
False bipolar pathway with unipolar lead – When implanting a unipolar lead, ensure that the tip setscrew is
properly engaged and that all electrical contacts are sealed to prevent electrical leakage. Electrical leakage may
cause the device to inappropriately identify a unipolar lead as bipolar, resulting in loss of output.
Magnets – Placing a magnet over the device suspends tachyarrhythmia detection and initiates asynchronous,
fixed-rate bradycardia pacing. The programming head contains a magnet that can cause magnet operation to
occur. However, magnet operation does not occur if telemetry between the device and the programmer is
established or if the MRI SureScan mode is programmed to On.
Pace polarity – Pace polarity must be bipolar to program the MRI SureScan mode to On.
Pacing and sensing safety margins – Lead maturation (at least one month after implant) may cause sensing
amplitudes to decrease and pacing thresholds to increase, which can cause undersensing or a loss of capture.
Provide an adequate safety margin when selecting values for pacing amplitude, pacing pulse width, and sensitivity
parameters.
Programmers – Use only Medtronic programmers and application software to communicate with the device.
Programmers and software from other manufacturers are not compatible with Medtronic devices.
Rate-responsive modes – Do not program rate-responsive modes for patients who cannot tolerate rates above
the programmed Lower Rate. Rate-responsive modes may cause discomfort for those patients.
Right ventricular apical pacing – Right ventricular apical pacing may be associated with an increased risk of
atrial fibrillation, left ventricular dysfunction, and congestive heart failure.
Maximum output for the RV Capture Management feature – The RV Capture Management feature does not
program right ventricular outputs to values greater than 5.0 V or 1.0 ms. If the patient needs right ventricular pacing
output greater than 5.0 V or 1.0 ms, manually program right ventricular amplitude and pulse width. If a lead
dislodges partially or completely, the RV Capture Management feature may not prevent loss of capture.
Sensitivity setting – Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before
changing the sensitivity from its nominal setting to a more sensitive setting.
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