Boston Scientific S-ICD System Manual

Passing Criteria
• Evaluate ECG lead:
- ECG lead is successful if all QRS complexes pass the screening evaluation in all postures
- Morphology of QRS is consistent across both postures, supine and standing or supine and sitting
- A patient is considered suitable for implant if at least one surface ECG lead (sense vector) is acceptable for all
tested postures.
- For Questions or Concerns, please Call 1-800-CARDIAC (Fax: [phone])
ECG Electrode Placement:
LL: Placed lateral location, at the 5th intercostal
space along the mid-axillary line
LA: Placed 1cm left lateral of the xiphoid midline
RA: Placed 14 cm superior to the ECG Electrode
(14cm guide is located on screening tool)
RL: Ground: either on the right hip or leg for
best placement to avoid noise
Obtain a Clean ECG
• Establish a stable baseline
• Record 10 – 20 seconds of ECG in 2 different postures - supine and standing, or supine and sitting
• ECG recording:
- Leads: I, II and III
- Sweep speed: 25 mm/sec
- ECG gain: 5 – 20 mm/mV
• Use the largest ECG gain that does not clip the peak of the QRS complex
• To yield an acceptable signal for testing, the gain may be adjusted for each ECG lead independently
• Troubleshooting suggestions to help establish a stable baseline:
- Add ground electrode (RL) - Ask patient to inhale then exhale and hold 10 sec. to manage respiratory artifact
- Ensure electrodes are new - Add electrode gel
2
Evaluate the ECG
• Select the colored profile from the Patient Screening Tool that best matches
the amplitude of the QRS complex:
- The peak of the QRS complex must fit within one of the Peak Zones as shown
- For biphasic signals, the larger peak should be used to select the profile
- ECG gains > 20 mm/mV are not permitted
• Align the left edge of the selected colored profile with the onset of the QRS complex:
- The horizontal line on the colored profile should be used as a guide for the
ECG baseline
• Evaluate each QRS complex:
- Ensure the entire QRS complex and trailing T-wave are contained within the
colored profile
- Repeat the evaluation process for all QRS complexes from all surface ECG leads
in all collected postures
3
4
Note: If viewing a faxed or scanned copy of an ECG, check scaling to confirm appropriate size.
Setup
• Remove hair and clean skin prior to placing surface electrode
• Start with patient laying supine
• Identify Xiphoid Process (Ask patient to “draw in” their stomach. Palpate the edge of the ribcage, moving toward the
midline, until they meet at the Xiphoid Process)
• Place electrodes starting with LA lead
• Use screening tool to determine RA lead location
1
S-ICDTM System
Patient Screening Steps
Prior to use, please review full S-ICD Directions for Use

The S-ICDTM System from Boston Scientific CRM
Indication for Use: The S-ICD System is intended to provide defibrillation 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 pacemakers are contraindicated for use with the S-ICD System.
Warnings and Cautions: The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the components of the SICD System with care at all times and maintain proper
sterile technique. All Cameron Health implantable components are designed for use with the Cameron Health S-ICD System only. Connection of any S-ICD System components to any other ICD
system will result in failure to deliver lifesaving defibrillation therapy.
General: External defibrillation equipment should be available for immediate use during the implantation procedure and follow-up. • Placing a magnet over the SQ-RX Pulse Generator suspends
arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response. • Battery depletion will eventually cause the SQ-RX Pulse Generator to
stop functioning. Defibrillation and excessive numbers of charging cycles shorten the battery longevity. • The S-ICD System has not been evaluated for pediatric use. • The S-ICD System does not
provide long-term bradycardia pacing, Cardiac Resynchronization Therapy (CRT) or Anti-Tachycardia Pacing (ATP).
Potential Adverse Events related to implantation of the S-ICD System may include, but are not limited to, the following: Acceleration/induction of atrial or ventricular arrhythmia; Adverse
reaction to induction testing; Allergic/adverse reaction to system or medication; Bleeding; Conductor fracture; Cyst formation; Death; Delayed therapy delivery; Discomfort or prolonged healing
of incision; Electrode deformation and/or breakage; Electrode insulation failure; Erosion/extrusion; Failure to deliver therapy; Fever; Hematoma; Hemothorax; Improper electrode connection
to the device; Inability to communicate with the device; Inability to defibrillate or pace; Inappropriate post-shock pacing; Inappropriate shock delivery; Infection; Keloid formation; Migration or
dislodgement; Muscle stimulation; Nerve damage; Pneumothorax; Post-shock/post-pace discomfort; Premature battery depletion; Random component failures; Stroke; Subcutaneous emphysema;
Surgical revision or replacement of the system; Syncope; Tissue redness, irritation, numbness or necrosis.
S-ICD, SQ-RX and Q-TRAK are registered trademarks of Cameron Health, Inc. Q-TECH, Q-GUIDE and INSIGHT are trademarks of Cameron Health, Inc.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. C)
Rhythm Management
One Boston Scientific Place
Natick, MA 01760-1537 USA
www.bostonscientific.com
Medical Professionals:
1.800.CARDIAC (227.3422)
Patients and Families:
1.866.484.3268
© 2014 Boston Scientific Corporation
or its affiliates. All rights reserved.
CRM-223202-AA APR2014
Information for the use in countries with applicable Health Authority product registrations.