Boston Scientific S-ICD System Скачать руководство пользователя страница 1

     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)

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

 

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    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

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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

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S-ICD

TM

 

System

Patient Screening Steps

Prior to use, please review full S-ICD Directions for Use

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