Boston Scientific EMBLEM S-ICD User Manual
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Boston Scientific EMBLEM S-ICD User Manual

Boston Scientific EMBLEM S-ICD User Manual

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PULSE GENERATOR USER'S MANUAL
EMBLEM™ S-ICD
Subcutaneous Implantable Cardioverter Defibrillator
A209

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Summary of Contents for Boston Scientific EMBLEM S-ICD

  • Page 1 PULSE GENERATOR USER'S MANUAL EMBLEM™ S-ICD Subcutaneous Implantable Cardioverter Defibrillator A209...
  • Page 2 EMBLEM is a trademark of Boston Scientific. This product may be protected by one or more patents. Patent information can be obtained at http://www. bostonscientific.com/patents. List of Acronyms Anti-tachycardia pacing Beginning of life Cardiopulmonary resuscitation Cardiac resynchronization therapy Defibrillation threshold...

  • Page 3: Table Of Contents

    Table of Contents Description Related Information Intended Audience Indications for Use Contraindications Warnings General Handling Implantation Post-Implant Precautions Clinical Considerations Sterilization and Storage Implantation Device Programming Environmental and Medical Therapy Hazards Hospital and Medical Environments Home and Occupational Environments Follow-up Testing Explant and Disposal Supplemental Precautionary Information Potential Adverse Events...
  • Page 4 Shelf Mode Therapy On Mode Therapy Off Mode Sensing Configuration and Gain Selection Sensing and Tachyarrhythmia Detection Detection Phase Certification Phase Decision Phase Therapy Zones Analysis in the Conditional Shock Zone Charge Confirmation Therapy Delivery Smart Charge Redetection Shock Waveform and Polarity Post-Shock Bradycardia Pacing Therapy Manual and Rescue Shock Delivery Additional Features of the S-ICD System...
  • Page 5 Creating the Device Pocket Implanting the EMBLEM S-ICD Subcutaneous Electrode Connecting the Subcutaneous Electrode to the Device Setting up the EMBLEM S-ICD Pulse Generator using the Model 3200 S-ICD Programmer Defibrillation Testing Complete and Return the Implantation Form Patient Counseling Information...

  • Page 7: Description

    Description The EMBLEM S-ICD pulse generator (the “device”) is a component of the Boston Scientific 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.

  • Page 8: Handling

    Component Compatibility. All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific 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 defibrillation therapy.

  • Page 9: Post-Implant

    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.

  • Page 10: Sterilization And Storage

    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 Scientific for inspection. •...

  • Page 11: Device Programming

    • Do not bend the subcutaneous electrode near the electrode-header interface. Insert the subcutaneous electrode connector straight into the pulse generator header port. Do not bend the subcutaneous electrode near the subcutaneous electrode-header interface. Improper insertion can cause insulation or connector damage. •...

  • Page 12: Environmental And Medical Therapy Hazards

    • Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmed parameters are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy. Environmental and Medical Therapy Hazards • 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.
  • Page 13 • Cardiopulmonary resuscitation. Cardiopulmonary resuscitation (CPR) may temporarily interfere with sensing and may cause delay of therapy. • 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.
  • Page 14 • Electrocautery and Radio Frequency (RF) Ablation. Electrocautery and RF ablation may induce ventricular arrhythmias and/or fibrillation, and may cause inappropriate shocks and inhibition of post-shock pacing. Additionally, exercise caution when performing any other type of cardiac ablation procedure in patients with implanted devices. If electrocautery or RF ablation is medically necessary, observe the following to minimize risk to the patient and device: ›...
  • Page 15 You should also perform a thorough follow-up evaluation of the pulse generator following TENS, to ensure that device function has not been compromised ("Post Therapy Pulse Generator Follow-Up" on page 12). For additional information, contact Boston Scientific using the information on the back cover.

  • Page 16: Home And Occupational Environments

    Elevated Pressures. The International Standards Organization (ISO) has not approved a standardized pressure test for implantable pulse generators that experience hyperbaric oxygen therapy (HBOT) or SCUBA diving. However, Boston Scientific developed a test protocol to evaluate device performance upon exposure to elevated atmospheric pressures. The following summary of pressure testing should not be viewed as and is not an endorsement of HBOT or SCUBA diving.
  • Page 17 If you have additional questions, or would like more detail regarding the test protocol or test results specific to HBOT or SCUBA diving, contact Boston Scientific using the information on the back cover.

  • Page 18: Follow-Up Testing

    Contact Boston Scientific, using the information on the back cover, for help in determining feasibility of device follow-up in the patient’s destination country.

  • Page 19: Potential Adverse Events

    › Reviewing stored events, fault codes, and real-time S-ECGs prior to saving all patient data › Testing the subcutaneous electrode impedance › Verifying battery status › Printing any desired reports › Verifying the appropriate final programming prior to allowing the patient to leave the clinic ›...
  • Page 20 • Inappropriate post shock pacing • Inappropriate shock delivery • Infection • Keloid formation • Migration or dislodgement • Muscle/nerve stimulation • Nerve damage • Pneumothorax • Post-shock/post-pace discomfort • Premature battery depletion • Random component failures • Stroke • Subcutaneous emphysema •...

  • Page 21: Patient Screening

    (1) Collecting the surface ECG, (2) Evaluating the surface ECG and (3) Determining an acceptable sense vector. The patient screening tool can be obtained from any Boston Scientific representative or by contacting Boston Scientific using the information on the back cover.
  • Page 22 SIMULTANEOUS 3-LEAD ECG 1. RECORD Supine + Standing 25 mm/s, 5-20 mm/mV Figure 2: Typical placement of surface ECG electrodes for patient screening Using a standard ECG machine, record 10 - 20 seconds of ECG using Leads I, II and III with a sweep speed of 25 mm/ sec and ECG gain between 5 - 20 mm/mV (use the largest ECG gain that does not result in clipping).

  • Page 23: Evaluating The Surface Ecg

    Evaluating the Surface ECG Each surface ECG should be evaluated by analyzing at least 10 seconds of QRS complexes. If multiple morphologies are noted (e.g., bigeminy, pacing, etc.), all morphologies should be tested as described below before the vector is deemed acceptable. Each QRS complex is evaluated as follows: Select the colored profile from the Patient Screening Tool that best matches the amplitude of the QRS (Figure 3).

  • Page 24: Determining An Acceptable Sense Vector

    3. VERIFY at least one lead is acceptable in all postures. Figure 4: Evaluating the QRS complex Repeat the above steps with all QRS complexes collected with all surface ECG leads in all collected postures. Determining an Acceptable Sense Vector Each collected surface ECG lead represents a sense vector of the S-ICD System.

  • Page 25: Operation

    Operation General The S-ICD System is designed for ease of use and simplicity of patient management. The arrhythmia detection system employs up to two rate zones, and the device has a single automatic response to a detected ventricular tachyarrhythmia – a nonprogrammable, maximum-energy, biphasic shock of 80 J.

  • Page 26: Sensing Configuration And Gain Selection

    Note: Manual and rescue shock therapy are available when the device is set to Therapy On or Therapy Off mode, but only after the initial Setup process is complete. Refer to Setting up the EMBLEM S-ICD Pulse Generator on page 43.

  • Page 27: Certification Phase

    Certification Phase The Certification Phase examines the detections and classifies them as certified cardiac events or as suspect events. Certified events are used to ensure that an accurate heart rate is passed to the Decision Phase. A suspect event can be one whose pattern and/or timing indicates the signal is caused by noise, such as a muscle artifact or some other extraneous signal.

  • Page 28: Analysis In The Conditional Shock Zone

    The device declares a Tachycardia when the 4RR average enters either therapy zone. Once a Tachycardia is declared, the 4RR average must become longer (in ms) than the lowest rate zone plus 40 ms for 24 cycles for the device to consider the episode to have ended. In the Shock Zone, treatable arrhythmias are determined by rate alone. Analysis in the Conditional Shock Zone In contrast, rate and morphology are analyzed in the Conditional Shock Zone.

  • Page 29: Charge Confirmation

    Charge Confirmation The device must charge the internal capacitors before shock delivery. Confirmation of the ongoing presence of a tachyarrhythmia requires monitoring a moving window of the 24 most recent intervals defined by certified events. Charge confirmation employs an X (treatable interval) out of Y (total intervals in the window) strategy to accomplish this. If 18 of the 24 most recent intervals are found to be treatable, the device begins to analyze rhythm persistence.

  • Page 30: Redetection

    Redetection A blanking period is enabled following delivery of a high-voltage shock. After delivery of the first shock, up to four additional shocks will be delivered if the episode does not terminate. Rhythm analysis for delivering shocks 2 - 5 generally follows the detection steps described above, with the following exceptions: Following the first shock delivery, the X/Y criterion is modified to require 14 treatable intervals in the last 24 (14/24), rather than 18.

  • Page 31: Additional Features Of The S-Icd System

    Additional Features of the S-ICD System This section presents descriptions of several additional features available in the S-ICD System. Auto Capacitor Reformation The device automatically performs a full-energy (80 J) capacitor reformation when taken out of Shelf mode and every four months until the device reaches Elective Replacement (ERI).

  • Page 32: System Diagnostics

    System Diagnostics The S-ICD System automatically performs a diagnostic check at scheduled intervals. Subcutaneous Electrode Impedance A subcutaneous electrode integrity test is performed once a week using a sub-threshold energy pulse. The Summary report indicates whether the measured impedance is in range by reporting "Ok" for values below 400 ohms. Values above 400 ohms will result in activation of the internal warning system (beeping tones).

  • Page 33: Storing And Analyzing Data

    Episode data associated with induction testing commanded by the programmer using the Hold to Induce button is captured by the programmer and is available as a captured S-ECG (see the EMBLEM S-ICD Programmer User’s Manual for more details).

  • Page 34: S-Ecg Rhythm Strip Markers

    S-ECG Rhythm Strip Markers The system provides S-ECG annotations (Table 2) to identify specific events during a recorded episode. Sample annotations are shown for the programmer display (Figure 7) and the printed report (Figure 8). Table 2: S-ECG Markers on Programmer Display Screens and Printed Reports Description Marker Charging...

  • Page 35: Patient Data

    Figure 7: Programmer display markers Figure 8: Printed Report Markers Patient Data The device can store the following patient data, which can be retrieved and updated through the programmer: • Patient’s name • Physician’s name and contact information • Device and subcutaneous electrode identification information (model and serial numbers) and implant date •...

  • Page 36: S-Icd System Magnet Use

    S-ICD System Magnet Use The Boston Scientific magnet Model 6860 (the magnet) is a non-sterile accessory that may be used to temporarily inhibit the delivery of therapy from the device if necessary. The Cameron Health magnet Model 4520 may be used interchangeably with the Boston Scientific magnet for this purpose.

  • Page 37: Magnet Use For Patients With Deep Implant Placement

    Figure 10: Grey shading indicates the zone within which magnet placement is most likely to suspend therapy, as signaled by beeping tones. Sweep the magnet vertically and horizontally across the target zone as indicated by the arrows. Magnet use for patients with deep implant placement Consider the following when using the magnet on patients with deep implant placement: •...

  • Page 38: Magnet Response And Pulse Generator Mode

    Warning: 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. Magnet Response and Pulse Generator Mode The effect of the magnet on the pulse generator varies depending on the Mode the pulse generator is programmed to (Shelf, Therapy On, or Therapy Off) as shown in Table 3.

  • Page 39: Bidirectional Torque Wrench

    If this occurs, the broken tip must be extracted from the setscrew using forceps. This torque wrench may also be used for loosening setscrews on other Boston Scientific pulse generators and lead accessories that have setscrews that tighten against a stop when fully retracted (these setscrews typically have clear seal plugs). However, when retracting these setscrews, stop turning the torque wrench when the setscrew has come in contact with the stop.

  • Page 40: Check Equipment

    Warning: All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific 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 defibrillation therapy.

  • Page 41: Interrogate And Check The Pulse Generator

    Upon connection with the pulse generator, the programmer will display an alert if the pulse generator battery status is below the appropriate level for a device at implant. If a battery alert appears, contact Boston Scientific using the information on the back cover.

  • Page 42: Implanting The Emblem S-Icd Subcutaneous Electrode

    Implanting the EMBLEM S-ICD Subcutaneous Electrode The procedure described below is one of several surgical approaches that can be used to appropriately implant and position the electrode. Regardless of the surgical approach, the defibrillation coil must be positioned parallel to the sternum, in close proximity to, or in contact with the deep fascia, approximately 2 cm from the sternal midline (Figure 11).
  • Page 43 With the subcutaneous electrode attached, carefully pull the EIT back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges. Place a suture sleeve over the subcutaneous electrode shaft 1 cm below the proximal sensing electrode. Using the preformed grooves, bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture material, making sure not to cover the proximal sensing electrode.
  • Page 44 Once the distal tip of the EIT emerges from the superior incision, disconnect and retain the suture loop from the distal tip of the EIT. Secure the ends of the suture with a surgical clamp. Remove the EIT. Using the secured suture at the superior incision, carefully pull the suture and subcutaneous electrode through the tunnel until the anchoring hole emerges.

  • Page 45: Connecting The Subcutaneous Electrode To The Device

    13. Gently tug the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to the fascia. 14. To dispose of the EIT, return the used product to the original package, then dispose in a biohazard container. 15.
  • Page 46 Figure 16: Inserting the torque wrench With the torque wrench in place, fully insert the subcutaneous electrode terminal into the electrode port. Grip the subcutaneous electrode close to the connector and insert it straight into the connector port. The electrode is fully inserted when the tip of the connector is visible beyond the connector block when viewed from the top.
  • Page 47 TOP VIEW No electrode inserted Setscrew Electrode fully inserted Tip of connector Setscrew Electrode Figure 17: Position of the subcutaneous electrode connector Warning: 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.
  • Page 48 Apply gentle downward pressure on the torque wrench until the blade is fully engaged within the setscrew cavity, taking care to avoid damage to the seal plug. Tighten the setscrew by slowly turning the torque wrench clockwise, until it ratchets once. The torque wrench is preset to apply the proper amount of force to the captive setscrew; additional rotation and force is unnecessary.

  • Page 49: Setting Up The Emblem S-Icd Pulse Generator Using The Model 3200 S-Icd Programmer

    A brief setup process must be completed before the device can deliver manual or automatic therapy. Additional details can be found in the EMBLEM S-ICD Model 3200 Programmer User's Manual. This process can be performed automatically or manually during the implant procedure, although Automatic Setup is recommended. During setup, the system automatically: •...

  • Page 50: Defibrillation Testing

    To initiate the Automatic Setup process: After using the programmer to scan for devices, choose the device being implanted from the Device List screen. The programmer will connect to the chosen pulse generator and the Device Identification screen will appear. Choosing the Continue button from this screen removes the pulse generator from Shelf Mode and causes the Automatic Setup screen to appear.

  • Page 51: Complete And Return The Implantation Form

    (80 J). Note: The EMBLEM S-ICD pulse generator can deliver a maximum of five shocks per episode. At any time, an 80 J rescue shock can be delivered by pressing the Rescue Shock button.

  • Page 52: Patient Counseling Information

    It is recommended that you discuss the information in the Patient Guide with concerned individuals both before and after implantation so they are fully familiar with pulse generator operation. For additional copies, contact Boston Scientific using the information on the back cover.

  • Page 53: Post Implant Follow-Up Procedures

    X-ray. When device communication with the programmer is established, the programmer automatically notifies the physician of any unusual conditions. Refer to the EMBLEM S-ICD Programmer User's Manual for more information. Patient management and follow-up are at the discretion of the patient's physician, but are recommended one month after implant and at least every 3 months to monitor the condition of the patient and evaluate device function.

  • Page 54: Explantation

    Note: Disposal of explanted pulse generators and/or subcutaneous electrodes is subject to applicable laws and regulations. For a Returned Product Kit, contact Boston Scientific using the information on the back cover. Caution: Be sure that the pulse generator is removed before cremation. Cremation and incineration temperatures might cause the pulse generator to explode.

  • Page 55: Loosening Stuck Setscrews

    • Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or subcutaneous electrode, and send it to Boston Scientific. Loosening Stuck Setscrews Follow these steps to loosen stuck setscrews: From a perpendicular position, tilt the torque wrench to the side 20º to 30º from the vertical center axis of the setscrew (Figure 20).

  • Page 56: Communication Compliance

    Additional Information Product Reliability It is Boston Scientific’s intent to provide implantable devices of high quality and reliability. However, these devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy. These malfunctions may include the following: •...

  • Page 57: Pulse Generator Longevity

    Pulse Generator Longevity Based on simulated studies, it is anticipated that these pulse generators have average longevity to EOL as shown below. At the time of manufacture, the device has the capacity for over 100 full energy shocks. The average projected longevity, which accounts for the energy used during manufacture and storage, assumes the following conditions: •...

  • Page 58: Specifications

    The pulse generator has an identifier that is visible on x-ray film or under fluoroscopy. This identifier provides noninvasive confirmation of the manufacturer and consists of the following: • The letters, BSC, to identify Boston Scientific as the manufacturer • The number, 507, to identify the Model 2877 S-ICD programmer software application needed to communicate with the pulse generator.
  • Page 59 59.5 connector (non- standard) a The EMBLEM S-ICD pulse generator is compatible with both the Cameron Health Model 3010 subcutaneous electrode and the EMBLEM S-ICD subcutaneous electrode. The pulse generator has a case electrode surface area of 111.0 cm Material Specfications •...
  • Page 60 Table 6: Programmable Parameters Nominal Parameter Programmable Values (as shipped) Shock Zone 170 bpm – 250 bpm (steps of 10 bpm) 220 bpm Conditional Shock Off, 170 bpm – 240 bpm 200 bpm Zone (If On, at least 10 bpm less than Shock Zone) S-ICD Pulse Shelf, Therapy On, Therapy Off Shelf...
  • Page 61 Table 7: Non-Programmable Parameters (Shock Therapy) Parameter Value SHOCK THERAPY Delivered Energy 80 J Peak Shock Voltage (80 J) 1328 V Shock Tilt (%) Waveform Type Biphasic Maximum Number of Shocks per 5 shocks episode Charge Time to 80 J (BOL/ERI) ≤10sec / ≤15sec Sync Time Out 1 sec...
  • Page 62 Table 8: Non-Programmable Parameters (Post-Shock Pacing) Parameter Value POST-SHOCK PACING Rate 50 ppm Pacing Output 200 mA Pulse Width (each phase) 7.6 ms Waveform Biphasic Polarity (first phase) Standard: Phase 1 Coil (+) Mode Inhibited Pacing Duration 30 sec 750 ms (first pace pulse) Post-Pace Blanking Period/ Refractory Period 550 ms (subsequent pace pulses)
  • Page 63 Table 9: Non-Programmable Parameters (Detection/Rhythm Discrimination, Fibrillation Induction, Sensing, Capacitor Reform Schedule, Internal Warning System) Parameter Value DETECTION/RHYTHM DISCRIMINATION X/Y for Initial Detection 18/24 intervals X/Y for Redetection 14/24 intervals Confirmation Before Shock 3 – 24 consecutive tachy intervals Refractory Period Fast 160 ms, Slow 200 ms FIBRILLATION INDUCTION Frequency...
  • Page 64 Table 10: Episode Data Parameters Parameter Value Treated Episodes 25 stored Untreated Episodes 20 stored Maximum Length per S-ECG Episode 128 sec Captured S-ECG Report Up to 15 (12 sec each) Table 11: Stored Patient Information Patient Information (Stored Data) Patient Name Physician Name Physician Contact Information...

  • Page 65: Definitions Of Package Label Symbols

    90 gauss minimum when measured at a distance of 1.5 in (3.8 cm) Field Strength from magnet surface Note: Specifications are also applicable to the Cameron Health magnet Model 4520. Definitions of Package Label Symbols Table 13: Packaging Symbols: EMBLEM S-ICD Pulse Generator Symbol Description Symbol Description...
  • Page 66 Symbol Description Symbol Description Consult instructions for Serial number CE mark of conformity with the identification of the Open here notified body authorizing use of the mark Do not reuse Manufacturer Do not use if package is Do not resterilize damaged Reference number Package contents...

  • Page 67: S-Icd System And Pacemaker Interaction

    S-ICD System and Pacemaker Interaction Warning: 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. Interaction between the S-ICD System and a temporary or permanent pacemaker is possible and can interfere with the identification of tachyarrhythmias in several ways.

  • Page 68: Warranty Information

    If inappropriate sensing is observed as a result of the device sensing the pacing artifact, reduce the pacemaker’s pacing output and retest. In addition, pacemaker operation may be affected by the S-ICD System therapy delivery. This could alter the pacemaker’s programmed settings or damage the pacemaker.
  • Page 70 © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA Guidant Europe NV/SA Boston Scientific Green Square, Lambroekstraat 5D 1831 Diegem, Belgium 0086 www.bostonscientific.com Authorized 2015 1.800.CARDIAC (227.3422) +1.651.582.4000...

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