cognis_100-d_physicians_technical_manual.pdf
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PHYSICIAN’S TECHNICAL MANUAL
COGNIS™ 100–D
CARDIAC RESYNCHRONIZATION THERAPY HIGH
ENERGY DEFIBRILLATOR
REF N106, N107, N108
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CONTENTS
New or Enhanced Features........................................................................................
Device Description......................................................................................................
Related Information ....................................................................................................
Indications and Usage ................................................................................................
Contraindications........................................................................................................
Warnings ....................................................................................................................
Precautions.................................................................................................................
Potential Adverse Events .........................................................................................
Mechanical Specifications ........................................................................................
Lead Connections.....................................................................................................
Items Included in Package .......................................................................................
Symbols on Packaging .............................................................................................
Characteristics as Shipped.......................................................................................
X-Ray Identifier.........................................................................................................
Pulse Generator Longevity .......................................................................................
Warranty Information ................................................................................................
Product Reliability.....................................................................................................
Patient Counseling Information ................................................................................
Patient Handbook.............................................................................................
Setscrew Locations ..................................................................................................
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2
5
6
6
6
8
26
29
31
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37
39
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NEW OR ENHANCED FEATURES
These pulse generator systems include additional features as compared to previous
products.
Ease of Use
•
•
ZOOMVIEW Programmer Software: the new user interface offers the following
benefits:
–
Clinical focus—features such as patient diagnostic trends and
indications-based programming emphasize the patient’s clinical condition
over device status and parameters.
–
Consistency—ZOOMVIEW software will be available on future pulse
generators, providing the same screens whether you are following a brady,
tachy, or heart failure device.
–
Simplicity—screen complexity is reduced through the use of progressive
disclosure (displaying the information you use frequently and minimizing the
information you only rarely access) and exception-based reporting.
Indications-Based Programming (IBP): the new ZOOMVIEW feature allows you
to quickly set up programming parameters based on the patient’s clinical needs
and indications.
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Tachy Therapy
•
Rhythm ID and Onset/Stability detection: the selection between detection
enhancements provides you the opportunity and flexibility to adjust for individual
patient conditions.
•
QUICK CONVERT ATP: in an attempt to avoid an otherwise scheduled charge
and painful shock for a pace-terminable fast ventricular tachycardia (VT), the
pulse generator delivers one rapid burst of antitachycardia pacing (ATP) for an
episode detected in the ventricular fibrillation (VF) zone.
•
Programmable Shock Vectors: this capability allows you to electronically change
the shocking vectors for added flexibility in treating high defibrillation thresholds
(DFTs).
Sensing
•
Sensing is designed to combine the strengths of both implantable cardioverter
defibrillator (ICD) and pacemaker sensing capabilities to improve detection and
therapy by reducing inappropriate mode switching, pacing inhibition, and shocks.
DEVICE DESCRIPTION
This manual contains information about the COGNIS 100 family of cardiac
resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in
"Mechanical Specifications" on page 29).
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Therapies
This family of pulse generators has a small, thin, physiologic shape that minimizes
pocket size and may minimize device migration. Pulse generators within this family
provide a variety of therapies, including:
•
Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated
with sudden cardiac death (SCD) such as VT and VF
•
Cardiac Resynchronization Therapy (CRT), which treats heart failure by
resynchronizing ventricular contractions through biventricular electrical stimulation
•
Bradycardia pacing, including adaptive rate pacing, to detect and treat
bradyarrhythmias and to provide cardiac rate support after defibrillation therapy
Cardioversion/defibrillation therapies include:
•
A range of low- and high-energy shocks using a biphasic waveform
•
The choice of multiple shock vectors:
–
Distal shock electrode to proximal shock electrode and pulse generator case
(TRIAD electrode system)
–
Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)
–
Distal shock electrode to pulse generator case (RV Coil to Can)
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Leads
The pulse generator has independently programmable outputs and accepts the
following leads:
•
One IS-11 atrial lead
•
One IS-1 coronary venous pace/sense lead
•
One LV-1 coronary venous pace/sense lead
•
One DF-1/IS-12 cardioversion/defibrillation lead
•
One GDT-LLHH multipolar connector cardioversion/defibrillation lead
CAUTION: The GDT-LLHH multipolar connector cardioversion/defibrillation lead is
intended for use only with pulse generators that are configured with the GDT-LLHH
connector.
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:
1.
2.
4
IS-1 refers to the international standard ISO 5841.3:2000.
DF-1 refers to the international standard ISO 11318:2002.
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•
Model 3120 Programmer/Recorder/Monitor (PRM)
•
Model 2868 ZOOMVIEW Software Application
•
Model 6577 Accessory Telemetry Wand
You can use the PRM system to do the following:
•
Interrogate the pulse generator
•
Program the pulse generator to provide a variety of therapy options
•
Access the pulse generator’s diagnostic features
•
Perform noninvasive diagnostic testing
•
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.
The Physician’s Technical Manual is packaged with the pulse generator. It provides the
technical information needed at implant.
Refer to the PRM system Operator’s Manual for specific information about the PRM
such as setup, maintenance, and handling.
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INDICATIONS AND USAGE
Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are
indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain
symptomatic despite stable, optimal heart failure drug therapy and have left ventricular
(LV) dysfunction (EF 35%) and QRS duration 120 ms.
CONTRAINDICATIONS
There are no contraindications for this device.
WARNINGS
General
•
Labeling knowledge. Read this manual thoroughly before implanting the pulse
generator to avoid damage to the system. Such damage can result in patient
injury or death.
•
Avoid shock during handling. Program the pulse generator Tachy Mode(s) to
Off during implant, explant, or postmortem procedures to avoid inadvertent high
voltage shocks.
•
Backup defibrillation protection. Always have sterile external and internal
defibrillation protection available during implant. If not terminated in a timely
fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
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•
Resuscitation availability. Ensure that an external defibrillator and medical
personnel skilled in CPR are present during post-implant device testing should the
patient require external rescue.
•
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.
•
Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to
MR device scanning. Strong magnetic fields may damage the device and cause
injury to the patient.
•
Diathermy. Do not subject a patient with an implanted pulse generator to
diathermy since diathermy may cause fibrillation, burning of the myocardium, and
irreversible damage to the pulse generator because of induced currents.
Programming and Device Operations
•
Atrial tracking modes. Do not use atrial tracking modes in patients with chronic
refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in
VT or VF.
•
Atrial-only modes. Do not use atrial-only modes in patients with heart failure
because such modes do not provide CRT.
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•
Ventricular sensing. Left ventricular lead dislodgement to a position near the
atria can result in atrial oversensing and left ventricular pacing inhibition.
•
Slow VT. Physicians should use medical discretion when implanting this
device in patients who present with slow VT. Programming therapy for slow
monomorphic VT may preclude CRT delivery at faster rates if these rates are
in the tachyarrhythmia zones.
Implant Related
•
Do not kink leads. Kinking leads may cause additional stress on the leads,
possibly resulting in lead fracture.
•
Patch leads. Do not use defibrillation patch leads with the pulse generator
system, or injury to the patient may occur.
•
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.
PRECAUTIONS
Clinical Considerations
•
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Pacemaker-mediated tachycardia (PMT). Retrograde conduction combined
with a short PVARP might induce PMT.
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Sterilization, Storage, and Handling
•
For single use only; do not resterilize devices. Do not resterilize the device
or the accessories packaged with it because the effectiveness of resterilization
cannot be ensured.
•
If package is damaged. The pulse generator blister trays and contents are
sterilized with ethylene oxide gas before final packaging. When the pulse
generator is received, it is sterile provided the container is intact. If the packaging
is wet, punctured, opened, or otherwise damaged, return the device to Boston
Scientific.
•
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.
•
Device storage. Store the pulse generator in a clean area away from magnets,
kits containing magnets, and sources of EMI to avoid device damage.
•
Use by date. Implant the device system 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.
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Implantation and Device Programming
•
Lead system. Do not use any lead with this device without first verifying
connector compatibility. Using incompatible leads can damage the connector
and/or result in potential adverse consequences, such as undersensing of cardiac
activity or failure to deliver necessary therapy.
•
Telemetry wand. Make sure the telemetry wand is connected to the programmer
and that it is available throughout the session. Verify that the wand cord is within
reach of the pulse generator.
•
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 decrease device longevity.
•
Biventricular pacing therapy. This device is intended to provide biventricular or
left ventricular pacing therapy. Programming the device to provide RV-only pacing
is not intended for the treatment of heart failure.
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•
Pacing and sensing margins. Consider lead maturation in your choice of pacing
amplitude, pacing pulse width, and sensitivity settings.
•
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.
•
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.
•
Pacing lead impedance should be within the range of 200 and 2000 .
•
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.
•
Proper programming of the lead configuration. If the Lead Configuration is
programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.
•
Proper programming of the shock vector. If the shock vector is programmed to
RVcoil>>RAcoil and the lead does not have an RA coil, shocking will not occur.
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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.
•
Defibrillation power surge. Defibrillation that causes a power surge exceeding
360 watt-seconds can damage the pulse generator system.
•
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.
•
AV Delay. To ensure a high percentage of biventricular pacing, the programmed
AV Delay setting must be less than the patient’s intrinsic PR interval.
•
Adaptive-rate pacing. Adaptive-rate 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.
•
Atrial Tachy Response (ATR). ATR should be programmed to On if the patient
has a history of atrial tachyarrhythmias. The delivery of CRT is compromised
because AV synchrony is disrupted if the ATR mode switch occurs.
•
Threshold test. During the LV threshold test, RV backup pacing is unavailable.
•
Left ventricular pacing only. The clinical effect of LV pacing alone for heart
failure patients has not been studied.
•
Do not bend the lead near the lead-header interface. Improper insertion can
cause insulation damage near the terminal end that could result in lead failure.
•
Shock waveform polarity. For IS-1/DF-1 leads, never change the shock
waveform polarity by physically switching the lead anodes and cathodes in the
pulse generator header—use the programmable Polarity feature. Device damage
or nonconversion of the arrhythmia post-operatively may result if the polarity
is switched physically.
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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.
•
Electrode connections. Do not insert a lead into the pulse generator connector
without first visually verifying that the setscrew is sufficiently retracted to allow
insertion. Fully insert each lead into its lead port and then tighten the setscrew
onto the electrodes.
•
Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse
generator’s Tachy Mode is programmed to Off when not in use and before handling
the device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.
•
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.
•
Defibrillation lead impedance. Never implant the device with a lead system that
has less than 15 total shock lead impedance. Device damage may result. If a
shocking lead impedance is less than 20 , reposition the shocking electrodes to
allow a greater distance between the shocking electrodes.
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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.
•
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.
•
Left ventricular lead configuration. Proper programming of the LV coronary
venous lead configuration is essential for proper LV lead function. Program the
lead configuration in accordance with the number of electrodes on the LV lead;
otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacing might
occur.
•
Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the
maximum LV pacing rate and may inhibit CRT at higher pacing rates.
•
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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•
Expected benefits. Determine whether the expected device benefits outweigh
the possibility of early device replacement for patients whose tachyarrhythmias
require frequent shocks.
•
Device communication. Use only the designated PRM and software application
to communicate with this pulse generator.
Environmental and Medical Therapy Hazards
•
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Avoid electromagnetic interference (EMI). Advise patients to avoid sources of
EMI because EMI may cause the pulse generator to deliver inappropriate therapy
or inhibit appropriate therapy. Examples of EMI sources are:
•
Electrical power sources, arc welding equipment, and robotic jacks
•
Electrical smelting furnaces
•
Large RF transmitters such as radar
•
Radio transmitters, including those used to control toys
•
Electronic surveillance (antitheft) devices
•
An alternator on a car that is running
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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.
•
Elevated Pressures. Elevated pressures due to hyperbaric chamber exposure of
SCUBA diving may damage the pulse generator. The pulse generator has been
tested to function normally at 1.5 Atmospheres Absolute (ATA) pressure or 15 ft
(4.6 m) depth in sea water. For specific guidelines prior to hyperbaric chamber
exposure, or if the patient is planning scuba diving activity, contact Technical
Services at the number shown on the back cover of this manual.
Hospital and Medical Environments
•
Mechanical ventilators. During mechanical ventilation, respiration rate trending
may be misleading; therefore, the Respiratory Sensor should be programmed
to Off.
•
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. Use of external defibrillation can damage the pulse
generator.
•
Transcutaneous electrical nerve stimulation (TENS). TENS may interfere
with pulse generator function. If necessary, the following measures may reduce
interference:
1.
Place the TENS electrodes as close to each other as possible and as far
from the pulse generator and lead system as possible.
2.
Monitor cardiac activity during TENS use.
For additional information, contact Technical Services at the number shown on
the back cover of this manual.
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•
Electrocautery. The use of electrocautery could induce ventricular arrhythmias
and/or fibrillation, cause asynchronous or inhibited pulse generator operation, or
cause the pulse generator to deliver an inappropriate shock. If electrocautery
cannot be avoided, observe the following precautions to minimize complications:
•
Select Electrocautery Protection Mode. Avoid direct contact with the pulse
generator or leads.
•
Monitor the patient and have temporary pacing equipment, external
defibrillation equipment, and knowledgeable medical personnel available.
•
Position the ground plate so that the current pathway does not pass through
or near the pulse generator system.
•
Use short, intermittent, and irregular bursts at the lowest feasible energy
levels.
•
Use a bipolar electrocautery system where possible.
Remember to reactivate the Tachy Mode after turning off the electrocautery equipment.
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•
Ionizing radiation therapy. Ionizing radiation therapy may adversely affect
device operation. During ionizing radiation therapy (e.g., radioactive cobalt,
linear accelerators, and betatrons), the pulse generator must be shielded with
a radiation-resistive material, regardless of the distance of the device to the
radiation beam. Do not project the radiation port directly at the device. After
waiting a minimum of one hour following radiation treatment (to allow for a device
memory check to occur), always evaluate device operation, including interrogation
and sensing and pacing threshold testing.
At the completion of the entire course of treatments, perform device interrogation
and follow-up, including sensing and pacing threshold testing and capacitor
re-formation.
•
Lithotripsy. Lithotripsy may permanently damage the pulse generator if the
device is at the focal point of the lithotripsy beam. If lithotripsy must be used, avoid
focusing near the pulse generator site.
The lithotriptor is designed to trigger off the R-wave on the ECG, resulting in shock
waves being delivered during the VRP.
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•
If the patient does not require pacing, program the pulse generator Brady
Mode to Off.
•
If the patient requires pacing, program the pulse generator to the VVI mode
because atrial pacing pulses can trigger the lithotriptor.
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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.
•
Radio frequency ablation. Exercise caution when performing radio frequency
ablation procedures in device patients. If the pulse generator Tachy Mode
is programmed to Monitor + Therapy during the procedure, the device may
inappropriately declare a tachycardia episode and deliver therapy. Pacing therapy
may also be inhibited unless the device is programmed to Electrocautery mode.
RF ablation may cause changes in pacing thresholds; evaluate the patient’s
thresholds appropriately.
Minimize risks by following these steps:
•
Program the Tachy Mode(s) to Electrocautery Protection to avoid inadvertent
tachycardia detection (sensing) or therapy.
•
Monitor the patient and have external defibrillation equipment and
knowledgeable medical personnel available.
•
Avoid direct contact between the ablation catheter and the implanted lead
and pulse generator.
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•
Keep the current path (electrode tip to ground) as far away from the pulse
generator and leads as possible.
•
Consider the use of external pacing support for pacemaker-dependent
patients (i.e., using internal or external pacing methods).
•
Monitor pre- and post-measurements for sensing and pacing thresholds and
impedances to determine the integrity of the lead-patient function.
Remember to reactivate the pulse generator after turning off the radio frequency
ablation equipment.
•
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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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•
Radio frequency (RF) interference. RF signals from devices that operate at
frequencies near that of the pulse generator may interrupt ZIP telemetry while
interrogating or programming the pulse generator. This RF interference can be
reduced by increasing the distance between the interfering device and the PRM
and pulse generator. Examples of devices that may cause interference include:
•
Cordless phone handsets or base stations
•
Certain patient monitoring systems
•
Remote control toys
Home and Occupational Environments
•
Home appliances. Home appliances that are in good working order and properly
grounded do not usually produce enough EMI to interfere with pulse generator
operation. There have been reports of pulse generator disturbances caused
by electric hand tools or electric razors used directly over the pulse generator
implant site.
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