Ingenio Physicians Technical Manual

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PHYSICIAN’S TECHNICAL MANUAL

INGENIO™

PACEMAKER

REF K182, K183, K184, K188

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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

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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.

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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.

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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:

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Avoid placing a pad (or paddle) directly over the pulse generator. Position

the pads (or paddles) as far from the pulse generator as possible.

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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.

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Set energy output of external defibrillation equipment as low as clinically

acceptable.

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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:

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Focus the ESWL beam at least 15 cm (6 in) away from the pulse generator.

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Depending on the pacing needs of the patient, program the Brady Mode to a

non-rate-responsive VVI or VOO mode.

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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.

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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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