Boston Scientific S-ICD System Directions For Use

S-ICD System
TM
Patient Screening Steps
Prior to use, please review full S-ICD Directions for Use
1

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
2

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)
- Ensure electrodes are new
3

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
4

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: 1-800-474-3245)
Note: If viewing a faxed or scanned copy of an ECG, check scaling to confirm appropriate size.
- Ask patient to inhale then exhale and hold 10 sec. to manage respiratory artifact
- Add electrode gel

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