Boston Scientific EMBLEM S-ICD User manual

PULSE GENERATOR USER'S MANUAL
EMBLEM™ S-ICD
Subcutaneous Implantable Cardioverter Debrillator
A209
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EMBLEM is a trademark of Boston Scientic.
This product may be protected by one or more patents. Patent information can be obtained at http://www.
bostonscientic.com/patents.
List of Acronyms
ATP Anti-tachycardia pacing
BOL Beginning of life
CPR Cardiopulmonary resuscitation
CRT Cardiac resynchronization therapy
DFT Debrillation threshold
EAS Electronic article surveillance
ECG Electrocardiogram
EGM Electrogram
EIT Electrode insertion tool
EMI Electromagnetic interference
EOL End of life
ERI Elective replacement indicator
ESWL Extracorporeal shock wave lithotripsy
HBOT Hyperbaric oxygen therapy
MRI Magnetic resonance imaging
NSR Normal sinus rhythm
PVC Premature ventricular contraction
S-ECG Subcutaneous electrocardiogram
S-ICD Subcutaneous implantable cardioverter debrillator
SVT Supraventricular tachycardia
TENS Transcutaneous electrical nerve stimulation
VF Ventricular brillation
VT Ventricular tachycardia
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Table of Contents
Description 1
Related Information 1
Intended Audience 1
Indications for Use 1
Contraindications 1
Warnings 1
General 1
Handling 2
Implantation 2
Post-Implant 3
Precautions 3
Clinical Considerations 3
Sterilization and Storage 4
Implantation 4
Device Programming 5
Environmental and Medical Therapy Hazards 6
Hospital and Medical Environments 6
Home and Occupational Environments 10
Follow-up Testing 12
Explant and Disposal 12
Supplemental Precautionary Information 12
Potential Adverse Events 13
Patient Screening 15
Collecting the Surface ECG 15
Evaluating the Surface ECG 17
Determining an Acceptable SenseVector 18
Operation 19
General 19
Modes of Operation 19
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Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
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Shelf Mode 19
Therapy On Mode 19
Therapy O Mode 19
Sensing Conguration and Gain Selection 20
Sensing and Tachyarrhythmia Detection 20
Detection Phase 20
Certication Phase 21
Decision Phase 21
Therapy Zones 21
Analysis in the Conditional Shock Zone 22
Charge Conrmation 23
Therapy Delivery 23
Smart Charge 23
Redetection 24
Shock Waveform and Polarity 24
Post-Shock Bradycardia PacingTherapy 24
Manual and Rescue Shock Delivery 24
Additional Features of the S-ICD System 25
Auto Capacitor Reformation 25
InternalWarning System – Beeper Control 25
Arrhythmia Induction 25
System Diagnostics 26
Subcutaneous Electrode Impedance 26
Device Integrity Check 26
Battery Performance Monitoring System 26
Storing and Analyzing Data 27
Treated Episodes 27
Untreated Episodes 27
Captured S-ECG 27
S-ECG Rhythm Strip Markers 28
Patient Data 29
S-ICD System Magnet Use 30
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Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Magnet use for patients with deep implant placement 31
Magnet Response and Pulse Generator Mode 32
Bidirectional Torque Wrench 33
Using the EMBLEM S-ICD Pulse Generator 33
Items Included in Package 33
Implanting the S-ICD System 33
Check Equipment 34
Interrogate and Check the Pulse Generator 35
Creating the Device Pocket 35
Implanting the EMBLEM S-ICD Subcutaneous Electrode 36
Connecting the Subcutaneous Electrode to the Device 39
Setting up the EMBLEM S-ICD Pulse Generator using the Model 3200 S-ICD Programmer 43
Debrillation Testing 44
Complete and Return the Implantation Form 45
Patient Counseling Information 46
Patient Guide 46
Post Implant Follow-Up Procedures 47
Explantation 48
Loosening Stuck Setscrews 49
Communication Compliance 50
Radio and Telecommunications Terminal Equipment (RTTE) 50
Additional Information 50
Product Reliability 50
Pulse Generator Longevity 51
Specications 52
X-ray Identier 52
Denitions of Package Label Symbols 59
S-ICD System and Pacemaker Interaction 61
Warranty Information 62
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

1
Description
The EMBLEM™S-ICD pulse generator (the“device”) is a component of the Boston Scientic S-ICD System, which is prescribed
for patients when cardiac arrhythmia management is warranted.The pulse generator accepts one EMBLEM S-ICD
subcutaneous electrode with an SQ-1 S-ICD connector.1The EMBLEM S-ICD pulse generator is also compatible with the
Cameron Health Model 3010 Q-TRAK subcutaneous electrode.
The pulse generator and subcutaneous electrode constitute the implantable portion of the S-ICD System. The pulse generator
can be used only with the EMBLEM S-ICD programmer Model 3200 and Model 3203 telemetry wand.
Related Information
For additional information about other components of the S-ICD System, refer to the following:
• EMBLEM S-ICD Subcutaneous Electrode User’s Manual
• EMBLEM S-ICD Subcutaneous Electrode InsertionTool User’s Manual
• EMBLEM S-ICD Programmer User’s Manual
Intended Audience
This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.
Indications for Use
The S-ICD System is intended to provide debrillation therapy for the treatment of life-threatening ventricular
tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous,
frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Contraindications
Unipolar pacing and impedance-based features are contraindicated for use with the S-ICD System.
Warnings
General
• Labeling knowledge. Read this manual thoroughly before using the S-ICD System to avoid damage to
the pulse generator and/or subcutaneous electrode. Such damage can result in patient injury or death.
1SQ-1 is a non-standard connector unique to the S-ICD System.
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
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2
• 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.
• Component Compatibility. All Boston Scientic S-ICD implantable components are designed for
use with the Boston Scientic or Cameron Health S-ICD System only. Connection of any S-ICD System
components to a non-compatible component will result in failure to deliver life-saving debrillation
therapy.
• Backup debrillation protection. Always have external debrillation equipment and medical
personnel skilled in CPR available during implant and follow-up testing. If not terminated in a timely
fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
• Pulse generator interaction. Using multiple pulse generators could cause pulse generator
interaction, resulting in patient injury or a lack of therapy delivery.Test each system individually and
in combination to help prevent undesirable interactions. Refer to the S-ICD System and Pacemaker
Interaction section on page 61 of this manual for more information.
Handling
• Proper Handling. Handle the components of the S-ICD System with care at all times and maintain
proper sterile technique. Failure to do so may lead to injury, illness, or death of the patient.
• Do not damage components. Do not modify, cut, kink, crush, stretch or otherwise damage any
component of the S-ICD System. Impairment to the S-ICD System may result in an inappropriate shock
or failure to deliver therapy to the patient.
• Handling the subcutaneous electrode. Use caution handling the subcutaneous electrode connector.
Do not directly contact the connector with any surgical instruments such as forceps, hemostats, or
clamps.This could damage the connector. A damaged connector may result in compromised sealing
integrity, possibly leading to compromised sensing, loss of therapy, or inappropriate therapy.
Implantation
• System dislodgement. Use appropriate anchoring techniques as described in the implant procedure
to prevent S-ICD System dislodgement and/or migration. Dislodgement and/or migration of the S-ICD
System may result in an inappropriate shock or failure to deliver therapy to the patient.
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

3
Post-Implant
• Magnet Response. Use caution when placing a magnet over the S-ICD pulse generator because it
suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia
detection and therapy response.
• Magnet response with deep implant placement. In patients with a deep implant placement
(greater distance between the magnet and the pulse generator) magnet application may fail to elicit
the magnet response. In this case the magnet cannot be used to inhibit therapy.
• Diathermy. Do not expose a patient with an implanted S-ICD System to diathermy. The interaction
of diathermy therapy with an implanted S-ICD pulse generator or electrode can damage the pulse
generator and cause patient injury.
• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning. Strong
magnetic elds may damage the pulse generator and/or subcutaneous electrode, possibly resulting in
injury to or death of the patient.
• Protected environments. Advise patients to seek medical guidance before entering environments
that could adversely aect 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.
• Sensitivity settings and EMI. The pulse generator may be more susceptible to low frequency
electromagnetic interference at induced signals greater than 80 uV. Oversensing of noise due to this
increased susceptibility could lead to inappropriate shocks and should be taken into consideration
when determining the follow-up schedule for patients exposed to low frequency electromagnetic
interference.The most common source of electromagnetic interference in this frequency range is the
power system for some European trains which operate at 16.6 Hz. Particular attention should be given
to patients with occupational exposure to these types of systems.
Precautions
Clinical Considerations
• Longevity. Battery depletion will eventually cause the S-ICD pulse generator to stop functioning.
Debrillation and excessive numbers of charging cycles shorten the battery longevity.
• Pediatric Use. The S-ICD System has not been evaluated for pediatric use.
• Available Therapies. The S-ICD System does not provide long-term bradycardia pacing, cardiac
resynchronization therapy (CRT) or anti-tachycardia pacing (ATP).
Outdated version. Do not use.
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Versión obsoleta. No utilizar.
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Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
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4
Sterilization and Storage
• If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before
nal packaging.When the pulse generator and/or subcutaneous electrode 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 subcutaneous electrode to Boston Scientic.
• If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf
package. Do not implant a device which has been dropped from a height of more than 24 inches (61 cm)
while within its intact shelf package. Sterility, integrity and/or function cannot be guaranteed under
these conditions and the device should be returned to Boston Scientic for inspection.
• Use by date. Implant the pulse generator and/or subcutaneous electrode before or on the USE BY date
on the package label because this date reects a validated shelf life. For example, if the date is January
1, do not implant on or after January 2.
• Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets,
and sources of EMI to avoid device damage.
• 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 aect initial
device function.
Implantation
• Avoid shock at implant. Verify the device is in Shelf mode or Therapy O to prevent the delivery of
unwanted shocks to the patient or the person handling the device during the implant procedure.
• 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.
• Creating the subcutaneous tunnel. Use only the electrode insertion tool to create the subcutaneous
tunnel when implanting and positioning the subcutaneous electrode.
• Suture location. Suture only those areas indicated in the implant instructions.
• Do not suture directly over subcutaneous electrode body. Do not suture directly over the
subcutaneous electrode body, as this may cause structural damage. Use the suture sleeve to prevent
subcutaneous electrode movement.
Outdated version. Do not use.
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Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
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Utdatert versjon. Skal ikke brukes.
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