ingenio__physicians_technical_manual.pdf
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PHYSICIAN’S TECHNICAL MANUAL
INGENIO™
PACEMAKER
REF K182, K183, K184, K188
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Table of Contents
Device Description......................................................................................................
Related Information ....................................................................................................
Indications and Usage ................................................................................................
Contraindications........................................................................................................
Warnings ....................................................................................................................
Precautions.................................................................................................................
Supplemental Precautionary Information .................................................................
Post-Therapy Pulse Generator Follow Up........................................................
Transcutaneous Electrical Nerve Stimulation (TENS)......................................
Electrocautery and Radio Frequency (RF) Ablation .........................................
Ionizing Radiation.............................................................................................
Elevated Pressures ..........................................................................................
Potential Adverse Events .........................................................................................
Mechanical Specifications ........................................................................................
Items Included in Package .......................................................................................
Symbols on Packaging .............................................................................................
Characteristics as Shipped.......................................................................................
X-Ray Identifier.........................................................................................................
Pulse Generator Longevity .......................................................................................
Warranty Information ................................................................................................
Product Reliability.....................................................................................................
Patient Counseling Information ................................................................................
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Patient Handbook.............................................................................................
Lead Connections.....................................................................................................
Implanting the Pulse Generator................................................................................
Step A: Check Equipment..............................................................................
Step B: Interrogate and Check the Pulse Generator .....................................
Step C: Implant the Lead System ..................................................................
Step D: Take Baseline Measurements...........................................................
Step E: Form the Implantation Pocket ...........................................................
Step F: Connect the Leads to the Pulse Generator.......................................
Step G: Evaluate Lead Signals......................................................................
Step H: Program the Pulse Generator...........................................................
Step I: Implant the Pulse Generator ..............................................................
Step J: Complete and Return the Implantation Form ....................................
Bidirectional Torque Wrench.....................................................................................
Follow Up Testing .....................................................................................................
Predischarge Follow Up ...................................................................................
Routine Follow Up ............................................................................................
Explantation..............................................................................................................
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Boston Scientific Corporation acquired Guidant Corporation in April 2006. During
our transition period, you may see both the Boston Scientific and Guidant names on
product and patient material. As we work through the transition, we will continue to
offer doctors and their patients technologically advanced and high quality medical
devices and therapies.
DEVICE DESCRIPTION
This manual contains information about the INGENIO family of implantable
pacemakers, including the following types of pulse generators (specific models are
listed in "Mechanical Specifications" on page 38):
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SR—single chamber pacemaker providing ventricular or atrial pacing and sensing
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DR—dual-chamber pacemaker providing ventricular and atrial pacing and sensing
Therapies
These pulse generators provide bradycardia pacing and adaptive rate pacing to detect
and treat bradyarrhythmias.
Leads
The pulse generator has independently programmable outputs and accepts one or
more of the following leads, depending on the model:
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One IS-11 unipolar or bipolar atrial lead
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One IS-1 unipolar or bipolar right ventricular lead
NOTE: Single-chamber devices will accept either an IS-1 atrial or an IS-1
ventricular lead.
The pulse generator and the leads constitute the implantable portion of the pulse
generator system.
PRM System
These pulse generators can be used only with the ZOOM LATITUDE Programming
System, which is the external portion of the pulse generator system and includes:
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Model 3120 Programmer/Recorder/Monitor (PRM)
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Model 2869 ZOOMVIEW Software Application
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Model 6577 Accessory Telemetry Wand
You can use the PRM system to do the following:
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Interrogate the pulse generator
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Program the pulse generator to provide a variety of therapy options
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Access the pulse generator’s diagnostic features
1.
IS-1 refers to the international standard ISO 5841-3:2000.
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•
Perform noninvasive diagnostic testing
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Access therapy history data
RELATED INFORMATION
Refer to the lead’s instruction manual for implant information, general warnings
and precautions, indications, contraindications, and technical specifications. Read
this material carefully for implant procedure instructions specific to the chosen lead
configurations.
Refer to the PRM system Operator’s Manual for specific information about the PRM
such as setup, maintenance, and handling.
INDICATIONS AND USAGE
Boston Scientific pacemakers are indicated for treatment of the following conditions:
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Symptomatic paroxysmal or permanent second- or third-degree AV block
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Symptomatic bilateral bundle branch block
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Symptomatic paroxysmal or transient sinus node dysfunction with or without
associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial
[SA] block
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Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some
forms of symptomatic tachyarrhythmias
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Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes
Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and
who may benefit from increased pacing rates concurrent with increases in minute
ventilation and/or level of physical activity.
Dual-chamber and atrial tracking modes are also indicated for patients who may benefit
from maintenance of AV synchrony.
Dual chamber modes are specifically indicated for treatment of the following:
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Conduction disorders that require restoration of AV synchrony, including varying
degrees of AV block
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VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus
rhythm
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Low cardiac output or congestive heart failure secondary to bradycardia
CONTRAINDICATIONS
These Boston Scientific pacemakers are contraindicated in patients who have a
separate implanted cardioverter-defibrillator (ICD).
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Use of certain pacing modes and/or features available in these Boston Scientific
pacemakers is contraindicated for the following patients under the circumstances listed:
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Minute ventilation in patients with both unipolar atrial and ventricular leads
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Single-chamber atrial pacing in patients with impaired AV nodal conduction
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Atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias
(atrial fibrillation or flutter), which might trigger ventricular pacing
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Dual-chamber and single-chamber atrial pacing in patients with chronic refractory
atrial tachyarrhythmias
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Asynchronous pacing in the presence (or likelihood) of competition between
paced and intrinsic rhythms
WARNINGS
General
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Labeling knowledge. Read this manual thoroughly before implantation to avoid
damage to the pulse generator and/or lead. Such damage can result in patient
injury or death.
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For single patient use only. Do not reuse, reprocess, or resterilize. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the
device and/or lead to device failure which, in turn, may result in patient injury,
illness, or death. Reuse, reprocessing, or resterilization may also create a risk
of contamination of the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious disease(s) from one
patient to another. Contamination of the device may lead to injury, illness, or
death of the patient.
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Backup defibrillation protection. Always have external defibrillation protection
available during implant and electrophysiologic testing. If not terminated in a timely
fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
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Separate pulse generator. Do not use this pulse generator with another pulse
generator. This combination could cause pulse generator interaction, resulting in
patient injury or a lack of therapy delivery.
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Safety Core operation. In response to applicable nonrecoverable or repeat fault
conditions, the pulse generator will switch irreversibly to Safety Core operation.
Safety Core pacing is unipolar, which is contraindicated for patients with an ICD.
Handling
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Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing
so could cause lead insulation abrasion damage or conductor damage.
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Programming and Device Operations
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Atrial tracking modes. Do not use atrial tracking modes in patients with chronic
refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in
ventricular tachyarrhythmias.
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Lead safety switch programmed to On. In devices with the lead safety switch
programmed to On, the lead polarity will switch to unipolar in the presence of a
lead impedance of ≤ 200 or ≥ 2000 Ω. Unipolar pacing is contraindicated for
patients with an ICD.
•
Sensitivity settings and EMI. If programmed to a fixed atrial sensitivity value
of 0.15 mV, the pulse generator may be more susceptible to electromagnetic
interference. This increased susceptibility should be taken into consideration
when determining the follow-up schedule for patients requiring such a setting.
Post-Implant
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Protected environments. Advise patients to seek medical guidance before
entering environments that could adversely affect the operation of the active
implantable medical device, including areas protected by a warning notice that
prevents entry by patients who have a pulse generator.
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Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI
scanning. Strong magnetic fields may damage the pulse generator and/or lead
system, possibly resulting in injury to or death of the patient.
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Diathermy. Do not subject a patient with an implanted pulse generator and/or lead
to diathermy since diathermy may cause fibrillation, burning of the myocardium,
and irreversible damage to the pulse generator because of induced currents.
PRECAUTIONS
Clinical Considerations
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STAT PACE. STAT PACE will initiate unipolar pacing.
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Pacemaker-mediated tachycardia (PMT). Programming minimum PVARP less
than retrograde V–A conduction may increase the likelihood of a PMT.
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Automatic Capture. Automatic Capture is intended for ventricular use only. Do
not program Amplitude to Auto for single-chamber devices implanted in the atrium.
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MV sensor modes. The safety and efficacy of the MV sensor modes have not
been clinically established in patients with abdominal implant sites.
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MV sensor mode performance. MV sensor performance may be adversely
affected under transient conditions such as pneumothorax, pericardial effusion, or
pleural effusion. Consider programming the MV sensor Off until these conditions
are resolved.
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Adaptive-rate modes. Adaptive-rate modes based completely or in part on MV
might be inappropriate for patients who can achieve respiratory cycles shorter
than one second (greater than 60 breaths per minute). Higher respiration rates
attenuate the impedance signal, which diminishes the MV rate response (i.e., the
pacing rate will drop toward the programmed LRL).
Adaptive-rate modes based completely or in part on MV should not be used for
patients with:
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An ICD
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Unipolar leads—for MV detection, a bipolar lead is required in either the
atrium or ventricle
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Epicardial ventricular leads—MV measurement has only been tested with
a bipolar transvenous lead
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A mechanical ventilator—use of the ventilator might result in an inappropriate
MV sensor-driven rate
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Sterilization and Storage
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If package is damaged. The blister trays and contents are sterilized with
ethylene oxide gas before final packaging. When the pulse generator and/or lead
is received, it is sterile provided the container is intact. If the packaging is wet,
punctured, opened, or otherwise damaged, return the pulse generator and/or
lead to Boston Scientific.
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Storage temperature and equilibration. Recommended storage temperatures
are 0°C–50°C (32°F–122°F). Allow the device to reach a proper temperature
before using telemetry communication capabilities, programming or implanting the
device because temperature extremes may affect initial device function.
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Device storage. Store the pulse generator in a clean area away from magnets,
kits containing magnets, and sources of EMI to avoid device damage.
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Use by date. Implant the pulse generator and/or lead before or on the USE BY
date on the package label because this date reflects a validated shelf life. For
example, if the date is January 1, do not implant on or after January 2.
Implantation
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Expected benefits. Determine whether the expected device benefits provided by
programmable options outweigh the possibility of more rapid battery depletion.
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Evaluate patient for surgery. There may be additional factors regarding the
patient’s overall health and medical condition that, while not related to device
function or purpose, could render the patient a poor candidate for implantation of
this system. Cardiac health advocacy groups may have published guidelines that
may be helpful in conducting this evaluation.
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Lead compatibility. Prior to implantation, confirm the lead-to-pulse generator
compatibility. Using incompatible leads and pulse generators can damage the
connector and/or result in potential adverse consequences, such as undersensing
of cardiac activity or failure to deliver necessary therapy.
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Telemetry wand. Make sure a sterile telemetry wand is available should loss
of ZIP telemetry occur. Verify that the wand can easily be connected to the
programmer and is within reach of the pulse generator.
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Line-powered equipment. Exercise extreme caution if testing leads using
line-powered equipment because leakage current exceeding 10 µA can induce
ventricular fibrillation. Ensure that any line-powered equipment is within
specifications.
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Replacement device. Implanting a replacement device in a subcutaneous pocket
that previously housed a larger device may result in pocket air entrapment,
migration, erosion, or insufficient grounding between the device and tissue.
Irrigating the pocket with sterile saline solution decreases the possibility of pocket
air entrapment and insufficient grounding. Suturing the device in place reduces
the possibility of migration and erosion.
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Do not bend the lead near the lead-header interface. Insert the lead terminal
straight into the lead port. Do not bend the lead near the lead-header interface.
Improper insertion can cause insulation or connector damage.
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Absence of a lead. The absence of a lead or plug in a lead port may affect
device performance. If a lead is not used, be sure to properly insert a plug in the
unused port, and then tighten the setscrew onto the plug.
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Dual chamber device without a functional RV lead. If a dual-chamber
device is programmed to AAI(R), ensure that a functional RV lead is present.
In the absence of a functional RV lead, programming to AAI(R) may result in
undersensing or oversensing.
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Electrode connections. Do not insert a lead into the pulse generator connector
without taking the following precautions to ensure proper lead insertion:
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Insert the torque wrench into the preslit depression of the seal plug before
inserting the lead into the port, to release any trapped fluid or air.
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Visually verify that the setscrew is sufficiently retracted to allow insertion.
Use the torque wrench to loosen the setscrew if necessary.
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Fully insert each lead into its lead port and then tighten the setscrew onto
the terminal pin.
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Shunting energy. Do not allow any object that is electrically conductive to come
into contact with the lead or device during induction because it may shunt energy,
resulting in less energy getting to the patient, and may damage the implanted
system.
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Do not suture directly over lead. Do not suture directly over the lead body, as
this may cause structural damage. Use the suture sleeve to secure the lead
proximal to the venous entry site to prevent lead movement.
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MV Sensor. Do not program the MV sensor to On until after the pulse generator
has been implanted and system integrity has been tested and verified.
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Device Programming
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Device communication. Use only the designated PRM and software application
to communicate with this pulse generator.
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STAT PACE settings. When a pulse generator is programmed to STAT PACE
settings, it will continue to pace at the high-energy STAT PACE values if it is not
reprogrammed. The use of STAT PACE parameters will likely decrease device
longevity.
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Pacing and sensing margins. Consider lead maturation in your choice of pacing
amplitude, pacing pulse width, and sensitivity settings.
•
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An acute pacing threshold greater than 1.5 V or a chronic pacing threshold
greater than 3 V can result in loss of capture because thresholds may
increase over time.
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An R-wave amplitude less than 5 mV or a P-wave amplitude less than 2 mV
can result in undersensing because the sensed amplitude may decrease
after implantation.
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Pacing lead impedance should be within the range of 200 Ω and 2000 Ω.
Lead impedance values and Lead Safety Switch. If leads with measured
impedance values approaching 200 or 2000 Ω are used, consider programming
Lead Safety Switch Off.
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Proper programming of the lead configuration. If the Lead Configuration is
programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.
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Programming for supraventricular tachyarrhythmias (SVTs). Determine if the
device and programmable options are appropriate for patients with SVTs because
SVTs can initiate unwanted device therapy.
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Adaptive-rate pacing. Rate adaptive pacing should be used with care in patients
who are unable to tolerate increased pacing rates.
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Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate
pacing is not limited by refractory periods. A long refractory period programmed in
combination with a high MSR can result in asynchronous pacing during refractory
periods since the combination can cause a very small sensing window or none at
all. Use dynamic AV Delay or dynamic PVARP to optimize sensing windows. If
you are entering a fixed AV delay, consider the sensing outcomes.
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Atrial oversensing. Take care to ensure that artifacts from the ventricles are
not present on the atrial channel, or atrial oversensing may result. If ventricular
artifacts are present in the atrial channel, the atrial lead may need to be
repositioned to minimize its interaction.
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ATR entry count. Exercise care when programming the Entry Count to low
values in conjunction with a short ATR Duration. This combination allows mode
switching with very few fast atrial beats. For example, if the Entry Count was
programmed to 2 and the ATR Duration to 0, ATR mode switching could occur on
2 fast atrial intervals. In these instances, a short series of premature atrial events
could cause the device to mode switch.
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ATR exit count. Exercise care when programming the Exit Count to low values.
For example, if the Exit Count was programmed to 2, a few cycles of atrial
undersensing could cause termination of mode switching.
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Proper programming without an atrial lead. If an atrial lead is not implanted
(port is plugged instead), or an atrial lead is abandoned but remains connected
to the header, device programming should be consistent with the number and
type of leads actually in use.
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MV Recalibration. To obtain an accurate MV baseline, the MV sensor will be
calibrated automatically or can be calibrated manually. A new, manual calibration
should be performed if the pulse generator is removed from the pocket following
implant, such as during a lead repositioning procedure, or in cases where the
MV baseline may have been affected by factors such as lead maturation, air
entrapment in the pocket, pulse generator motion due to inadequate suturing,
external defibrillation or cardioversion, or other patient complications (e.g.,
pneumothorax).
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Sensing adjustment. Following any Sensitivity parameter adjustment or any
modification of the sensing lead, always verify appropriate sensing. Programming
Sensitivity to the highest value (lowest sensitivity) may result in undersensing of
cardiac activity. Likewise, programming to the lowest value (highest sensitivity)
may result in oversensing of non-cardiac signals.
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Sensitivity in unipolar lead configuraton. The amplitude and prevalence of
myopotential noise is increased in unipolar lead configurations, as compared
to bipolar lead configurations. For patients with a unipolar lead configuration
and myopotential oversensing during activity involving the pectoral muscles, the
programming of Fixed Sensitivity is recommended.
Environmental and Medical Therapy Hazards
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Avoid electromagnetic interference (EMI). Advise patients to avoid sources of
EMI. The pulse generator may inhibit pacing due to oversensing, or may switch
to asynchronous pacing at the programmed pacing rate or at the magnet rate in
the presence of EMI.
Moving away from the source of the EMI or turning off the source usually allows
the pulse generator to return to normal operation.
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Examples of potential EMI sources are:
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Electrical power sources, arc welding or resistance welding equipment, and
robotic jacks
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High voltage power distribution lines
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Electrical smelting furnaces
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Large RF transmitters such as radar
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Radio transmitters, including those used to control toys
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Electronic surveillance (antitheft) devices
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An alternator on a car that is running
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Medical treatments and diagnostic tests in which an electrical
current is passed through the body, such as TENS, electrocautery,
electrolysis/thermolysis, electrodiagnostic testing, electromyography, or
nerve conduction studies
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Any externally applied device that uses an automatic lead detection alarm
system (e.g., an EKG machine)
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Radio and Telecommunications Terminal Equipment (RTTE). Boston Scientific
declares that this device is in compliance with the essential requirements and
other relevant provisions of the current RTTE directive.
NOTE: As with other telecommunications equipment, verify national data privacy
laws.
Hospital and Medical Environments
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Mechanical ventilators.
Program the MV Sensor to Off during mechanical ventilation. Otherwise, the following
may occur:
•
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Inappropriate MV sensor-driven rate
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Misleading respiration-based trending
Conducted electrical current. Any medical equipment, treatment, therapy, or
diagnostic test that introduces electrical current into the patient has the potential
to interfere with pulse generator function.
•
External patient monitors (e.g., respiratory monitors, surface ECG
monitors, hemodynamic monitors) may interfere with the pulse generator’s
impedance-based diagnostics (e.g., Respiratory Rate trend). This
interference may also result in accelerated pacing, possibly up to the
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maximum sensor-driven rate, when MV is programmed to On. To resolve
suspected interactions, deactivate the MV sensor either by programming it to
Off (no MV rate driving or MV sensor-based trending will occur), or Passive
(no MV rate driving will occur). Alternatively, program the Brady Mode to a
non-rate responsive mode (no MV rate driving will occur). If a PRM is not
available and the pulse generator is pacing at the sensor-driven rate, apply a
magnet to the pulse generator to initiate temporary asynchronous, non-rate
responsive pacing.
•
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Medical therapies, treatments, and diagnostic tests that use conducted
electrical current (e.g., TENS, electrocautery, electrolysis/thermolysis,
electrodiagnostic testing, electromyography, or nerve conduction studies)
may interfere with or damage the pulse generator. Program the device to
Electrocautery Mode prior to the treatment, and monitor device performance
during the treatment. After the treatment, verify pulse generator function
("Post-Therapy Pulse Generator Follow Up" on page 26).
Internal defibrillation. Do not use internal defibrillation paddles or catheters
unless the pulse generator is disconnected from the leads because the leads
may shunt energy. This could result in injury to the patient and damage to the
implanted system.
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External defibrillation. It can take up to 15 seconds for sensing to recover
after an external shock is delivered. In non-emergency situations, for
pacemaker dependent patients, consider programming the pulse generator to
an asynchronous pacing mode prior to performing external cardioversion or
defibrillation.
External defibrillation or cardioversion can damage the pulse generator. To help
prevent damage to the pulse generator, consider the following:
•
Avoid placing a pad (or paddle) directly over the pulse generator. Position
the pads (or paddles) as far from the pulse generator as possible.
•
Position the pads (or paddles) in a posterior-anterior orientation when the
device is implanted in the right pectoral region or an anterior-apex orientation
when the device is implanted in the left pectoral region.
•
Set energy output of external defibrillation equipment as low as clinically
acceptable.
•
In non-emergency situations, prior to performing external cardioversion or
defibrillation, program the MV sensor to Off.
Following external cardioversion or defibrillation, verify pulse generator function
("Post-Therapy Pulse Generator Follow Up" on page 26).
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Lithotripsy. Extracorporeal shock wave lithotripsy (ESWL) may cause
electromagnetic interference with or damage to the pulse generator. If ESWL
is medically necessary, consider the following to minimize the potential for
encountering interaction:
•
Focus the ESWL beam at least 15 cm (6 in) away from the pulse generator.
•
Depending on the pacing needs of the patient, program the Brady Mode to a
non-rate-responsive VVI or VOO mode.
•
Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damage
the pulse generator. If therapeutic ultrasound energy must be used, avoid focusing
near the pulse generator site. Diagnostic ultrasound (e.g., echocardiography) is
not known to be harmful to the pulse generator.
•
Electrical interference. Electrical interference or “noise” from devices such
as electrocautery and monitoring equipment may interfere with establishing or
maintaining telemetry for interrogating or programming the device. In the presence
of such interference, move the programmer away from electrical devices, and
ensure that the wand cord and cables are not crossing one another. If telemetry is
cancelled as a result of interference, the device should be re-interrogated prior to
evaluating information from pulse generator memory.
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