Boston Scientific DYNAGEN CRT-D Technical Manual
  1. Manuals
  2. Brands
  3. Boston Scientific Manuals
  4. Medical Equipment
  5. DYNAGEN CRT-D
  6. Technical manual

Boston Scientific DYNAGEN CRT-D Technical Manual

Cardiac resynchronization therapy defibrillator
Hide thumbs
Table of Contents

Advertisement

Quick Links

PHYSICIAN'S TECHNICAL MANUAL
DYNAGEN
INOGEN
ORIGEN
CARDIAC RESYNCHRONIZATION THERAPY
DEFIBRILLATOR
Model G150, G151, G154, G156, G158, G140, G141, G146, G148, G050, G051,
G056, G058
CAUTION: Federal law (USA)
restricts this device to sale by
or on the order of a physician
trained or experienced in
device implant and follow-up
procedures.
™
™
CRT-D, DYNAGEN
X4 CRT-D,
™
™
CRT-D, INOGEN
X4 CRT-D,
™
™
CRT-D, ORIGEN
X4 CRT-D

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the DYNAGEN CRT-D and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Boston Scientific DYNAGEN CRT-D

Summary of Contents for Boston Scientific DYNAGEN CRT-D

  • Page 1 PHYSICIAN’S TECHNICAL MANUAL ™ ™ DYNAGEN CRT-D, DYNAGEN X4 CRT-D, ™ ™ INOGEN CRT-D, INOGEN X4 CRT-D, ™ ™ ORIGEN CRT-D, ORIGEN X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Model G150, G151, G154, G156, G158, G140, G141, G146, G148, G050, G051, G056, G058 CAUTION: Federal law (USA) restricts this device to sale by...

  • Page 3: Table Of Contents

    Table of Contents Additional Technical Information..................... Device Description.......................... Related Information ........................Intended Audience ........................ Indications and Usage ........................Contraindications..........................Warnings ............................Precautions............................. Supplemental Precautionary Information ..................Post-Therapy Pulse Generator Follow Up ................Transcutaneous Electrical Nerve Stimulation (TENS)............Electrocautery and Radio Frequency (RF) Ablation............Ionizing Radiation........................
  • Page 4 Implanting the Pulse Generator....................Step A: Check Equipment ....................Step B: Interrogate and Check the Pulse Generator ............Step C: Implant the Lead System ..................Step D: Take Baseline Measurements ................Step E: Form the Implantation Pocket ................Step F: Connect the Leads to the Pulse Generator............Step G: Evaluate Lead Signals..................

  • Page 5: Additional Technical Information

    ADDITIONAL TECHNICAL INFORMATION For additional technical reference guides, go to www.bostonscientific.com/ifu. DEVICE DESCRIPTION This manual contains information about the DYNAGEN, INOGEN, and ORIGEN families of cardiac resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in "Mechanical Specifications" on page 28). NOTE: Specific features discussed in this manual may not apply to all models.
  • Page 6 • The choice of multiple shock vectors: – Distal shock electrode to proximal shock electrode and pulse generator case (TRIAD electrode system) – Distal shock electrode to proximal shock electrode (RV Coil to RA Coil) – Distal shock electrode to pulse generator case (RV Coil to Can) Leads The pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model:...

  • Page 7: Related Information

    PRM System These pulse generators can be used only with the ZOOM LATITUDE Programming System, which is the external portion of the pulse generator system and includes: • Model 3120 Programmer/Recorder/Monitor (PRM) • Model 3140 ZOOM Wireless Transmitter • Model 2868 ZOOMVIEW Software Application •...

  • Page 8: Intended Audience

    Intended Audience This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures. INDICATIONS AND USAGE These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: •...
  • Page 9 • Backup defibrillation protection. Always have external defibrillation equipment available during implant and electrophysiologic testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death. • Resuscitation availability. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue.
  • Page 10 • Appropriate lead connections. When implanting a system which uses both a DF4-LLHH/LLHO and IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Inserting a lead into an incorrect port will result in unanticipated device behavior (potentially leaving the patient without effective therapy).

  • Page 11: Precautions

    • Ensure PTM is enabled. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home by confirming the Magnet Response is programmed to Store EGM. If the feature is inadvertently left in the Inhibit Therapy setting, the patient could potentially disable tachyarrhythmia detection and therapy.
  • Page 12 • 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 affect initial device function. • Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets, and sources of EMI to avoid device damage.
  • Page 13 • Replacement device. Implanting a replacement device in a subcutaneous pocket that previously housed a larger device may result in pocket air entrapment, migration, erosion, or insufficient grounding between the device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility of pocket air entrapment and insufficient grounding.
  • Page 14 • Do not suture directly over lead. Do not suture directly over the lead body, as this may cause structural damage. Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead movement. Device Programming •...
  • Page 15 • Proper programming of the shock vector. If the shock vector is programmed to RVcoil>>RAcoil and the lead does not have an RA coil, shocking will not occur. • Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmable options are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy.
  • Page 16 • Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device. For tachyarrhythmia detection and therapy, verify that the Tachy Mode is programmed to Monitor + Therapy. •...
  • Page 17 • Sensing adjustment. Following any sensing range adjustment or any modification of the sensing lead, always verify appropriate sensing. Programming Sensitivity to the highest value (lowest sensitivity) may result in delayed detection or undersensing of cardiac activity. Likewise, programming to the lowest value (highest sensitivity) may result in oversensing of non-cardiac signals.
  • Page 18 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. Moving away from the source of the EMI or turning off the source usually allows the pulse generator to return to normal operation.
  • Page 19 Hospital and Medical Environments • Mechanical ventilators. During mechanical ventilation, respiration-based trending may be misleading; therefore, the Respiratory Sensor should be programmed to Off. • Conducted electrical current. Any medical equipment, treatment, therapy, or diagnostic test that introduces electrical current into the patient has the potential to interfere with pulse generator function. •...
  • Page 20 • External defibrillation. It can take up to 15 seconds for sensing to recover after an external shock is delivered. In non-emergency situations, for pacemaker dependent patients, consider programming the pulse generator to an asynchronous pacing mode and programming the Respiratory Sensor to Off prior to performing external cardioversion or defibrillation.
  • Page 21 • Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damage the pulse generator. If therapeutic ultrasound energy must be used, avoid focusing near the pulse generator site. Diagnostic ultrasound (e.g., echocardiography) is not known to be harmful to the pulse generator. •...
  • Page 22 • Magnetic fields. Advise patients that extended exposure to strong (greater than 10 gauss or 1 mTesla) magnetic fields may trigger the magnet feature. Examples of magnetic sources include: • Industrial transformers and motors • MRI scanners • Large stereo speakers •...

  • Page 23: Supplemental Precautionary Information

    • Follow-up considerations for patients leaving the country. Pulse generator follow-up considerations should be made in advance for patients who plan to travel or relocate post-implant to a country other than the country in which their device was implanted. Regulatory approval status for devices and associated programmer software configurations varies by country;...

  • Page 24: Transcutaneous Electrical Nerve Stimulation (Tens)

    • Reviewing clinical events and fault codes • Reviewing the Arrhythmia Logbook, including stored electrograms (EGMs) • Reviewing real-time EGMs • Testing the leads (threshold, amplitude, and impedance) • Performing a manual capacitor re-formation • Reviewing respiratory sensor-based diagnostics • Verifying battery status •...
  • Page 25 Additional steps can be taken to help reduce interference during in-clinic use of TENS: • If interference is suspected during in-clinic use, turn off the TENS unit. • Do not change TENS settings until you have verified that the new settings do not interfere with pulse generator function.

  • Page 26: Electrocautery And Radio Frequency (Rf) Ablation

    Electrocautery and Radio Frequency (RF) Ablation CAUTION: Electrocautery and RF ablation may induce ventricular arrhythmias and/or fibrillation, and may cause asynchronous pacing, inhibition of pacing, inappropriate shocks, and/or a reduction in pulse generator pacing output possibly leading to loss of capture. RF ablation may also cause ventricular pacing up to the MTR and/or changes in pacing thresholds.

  • Page 27: Ionizing Radiation

    Ionizing Radiation CAUTION: It is not possible to specify a safe radiation dosage or guarantee proper pulse generator function following exposure to ionizing radiation. Multiple factors collectively determine the impact of radiation therapy on an implanted pulse generator, including proximity of the pulse generator to the radiation beam, type and energy level of the radiation beam, dose rate, total dose delivered over the life of the pulse generator, and shielding of the pulse generator.

  • Page 28: Elevated Pressures

    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.

  • Page 29: Potential Adverse Events

    Table 1. Pressure Value Equivalencies (continued) Pressure value equivalencies kPa Absolute All pressures were derived assuming sea water density of 1030 kg/m Pressure as read on a gauge or dial (psia = psig + 14.7 psi). Prior to SCUBA diving or starting an HBOT program, the patient’s attending cardiologist or electrophysiologist should be consulted to fully understand the potential consequences relative to the patient’s specific health condition.
  • Page 30 • Chronic nerve damage • Component failure • Conductor coil fracture • Death • Electrolyte imbalance/dehydration • Elevated thresholds • Erosion • Excessive fibrotic tissue growth • Extracardiac stimulation (muscle/nerve stimulation) • Failure to convert an induced arrhythmia • Fluid accumulation •...
  • Page 31 • Lead perforation • Lead tip deformation and/or breakage • Local tissue reaction • Loss of capture • Myocardial infarction (MI) • Myocardial necrosis • Myocardial trauma (e.g., tissue damage, valve damage) • Myopotential sensing • Oversensing/undersensing • Pacemaker-mediated tachycardia (PMT) •...

  • Page 32: Mechanical Specifications

    • Fear of premature battery depletion • Fear of shocking while conscious • Fear that shocking capability may be lost • Imagined shocking • Fear of device malfunction Additionally, potential adverse events associated with the implantation of a coronary venous lead system include: •...
  • Page 33 Table 2. Mechanical Specifications - DYNAGEN CRT-Ds (continued) Model Dimensions Mass (g) Volume (cm Connector Type W x H x D (cm) G151 5.37 x 8.08 x 0.99 72.8 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS-1 G154 5.37 x 8.08 x 0.99 72.9 32.0 RA: IS-1;...
  • Page 34 Table 3. Mechanical Specifications - INOGEN CRT-Ds (continued) Model Dimensions Mass (g) Volume (cm Connector Type W x H x D (cm) G146 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 G148 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1;...

  • Page 35: Items Included In Package

    Material specifications are shown below: • Case: hermetically sealed titanium • Header: implantation-grade polymer • Power Supply: lithium-manganese dioxide cell; Boston Scientific; 401988 ITEMS INCLUDED IN PACKAGE The following items are included with the pulse generator: • One torque wrench •...
  • Page 36 Table 5. Symbols on packaging (continued) Symbol Description Pulse generator Torque wrench Literature enclosed Serial number Use by Lot number Date of manufacture...
  • Page 37 Table 5. Symbols on packaging (continued) Symbol Description Sterilized using ethylene oxide Do not resterilize Do not reuse Do not use if package is damaged Dangerous voltage Consult instructions for use...
  • Page 38 Table 5. Symbols on packaging (continued) Symbol Description Temperature limitation Place telemetry wand here Open here Authorized Representative in the European Community Manufacturer Investigational use only...

  • Page 39: Characteristics As Shipped

    Table 5. Symbols on packaging (continued) Symbol Description CRT-D RA, RV, LV ICD RA, RV ICD RV Uncoated device CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment (Table 6 on page 35). Table 6. Characteristics as shipped Parameter Setting Tachy Mode...
  • Page 40 Table 6. Characteristics as shipped (continued) Parameter Setting Pacing Mode Storage Pacing Therapy available DDDR Sensor Accelerometer Pace/Sense Configuration RA: BI/BI Pace/Sense Configuration RV: BI/BI Pace/Sense Configuration LV: Off Pace/Sense Configuration LV: BI/BI (Quadripolar Models) The pulse generator is shipped in a power-saving Storage mode to extend its shelf life. In Storage mode, all features are inactive except: •...

  • Page 41: X-Ray Identifier

    • Tachy Mode is programmed to: – – Monitor Only – Monitor + Therapy Once you have programmed the pulse generator out of Storage mode, the device cannot be reprogrammed to that mode. X-RAY IDENTIFIER 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: •...

  • Page 42: Federal Communications Commission (Fcc)

    [1] X-Ray Identifier [2] Header [3] Pulse Generator Case Figure 1. X-ray identifier For information on identifying the device via the PRM, refer to the PRM Operator’s Manual. The pulse generator model number is stored in device memory and is shown on the PRM Summary screen once the pulse generator is interrogated.

  • Page 43: Pulse Generator Longevity

    Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited.
  • Page 44 Table 7. Pulse generator life expectancy estimation (implant to explant) All Models Pacing Amplitude Longevity (years) at 500 Ω and 700 Ω Pacing Impedance (RV and LV) RA/RV 500 Ω 700 Ω 2.5 V 3.0 V 2.5 V 3.5 V 3.5 V 3.5 V 3.5 V...

  • Page 45: Warranty Information

    Longevity is also affected in the following circumstances: • A decrease in pacing impedance may reduce longevity. • When the Respiratory Sensor is programmed Off for the life of the device, longevity is increased by approximately 2 months. • When Patient Triggered Monitor is programmed to On for 60 days, longevity is reduced by approximately 5 days.

  • Page 46: Product Reliability

    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: • Premature battery depletion •...

  • Page 47: Patient Handbook

    • Signs and symptoms of infection • Symptoms that should be reported (e.g., sustained high-rate pacing requiring reprogramming) • Protected environments—the patient should seek medical guidance before entering areas protected by a warning notice that prevents entry by patients who have a pulse generator •...

  • Page 48: Lead Connections

    LEAD CONNECTIONS Lead connections are illustrated below. CAUTION: Prior to implantation, confirm the lead-to-pulse generator compatibility. Using incompatible leads and pulse generators can damage the connector and/or result in potential adverse consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy. CAUTION: If the Lead Configuration is programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.
  • Page 49 – DF-1 DF-1 IS-1 IS-1 LV-1 UNI/BI [1] Defib (-): Red [2] Defib (+): Blue [3] RA: White [4] LV: Green [5] RV: White [6] Defib (+) [7] Defib (-) [8] RA (-) [9] RV (-) [10] LV (-) [11] Suture Hole Figure 3.
  • Page 50 IS-1 IS-1 UNI/BI DF4-LLHH [1] RA: White [2] LV: Green [3] RV: Red [4] RA (-) [5] LV (-) [6] Suture Holes [7] RV (-) Figure 4. Lead connections and setscrew locations, RA: IS-1, RV: DF4-LLHH, LV: IS-1...
  • Page 51 – DF-1 DF-1 IS-1 IS-1 IS4-LLLL [1] Defib (-): Red [2] Defib (+): Blue [3] RA: White [4] LV: Green [5] RV: White [6] Defib (+) [7] Defib (-) [8] RA (-) [9] RV (-) [10] LV (-) [11] Suture Hole Figure 5.

  • Page 52: Implanting The Pulse Generator

    – DF-1 DF-1 IS-1 IS-1 IS-1 UNI/BI [1] Defib (-): Red [2] Defib (+): Blue [3] RA: White [4] LV: Green [5] RV: White [6] Defib (+) [7] Defib (-) [8] RA (-) [9] RV (-) [10] LV (-) [11] Suture Hole Figure 6.

  • Page 53: Step A: Check Equipment

    Step A: Check Equipment It is recommended that instrumentation for cardiac monitoring, defibrillation, and lead signal measurement should be available during the implant procedure. This includes the PRM system with its related accessories and the software application. Before beginning the implantation procedure, become completely familiar with the operation of all the equipment and the information in the respective operator’s and user’s manuals.

  • Page 54: Step C: Implant The Lead System

    Step C: Implant the Lead System The pulse generator requires a lead system for sensing, pacing, and delivering shocks. The pulse generator can use its case as a defibrillating electrode. Selection of lead configuration and specific surgical procedures is a matter of professional judgment. The following leads are available for use with the pulse generator depending on the device model.

  • Page 55: Step D: Take Baseline Measurements

    Implant the leads via the surgical approach chosen. NOTE: Should lead performance changes occur which cannot be resolved with programming, the lead may need to be replaced if no adapter is available. Step D: Take Baseline Measurements Once the leads are implanted, take baseline measurements. Evaluate the lead signals. If performing a pulse generator replacement procedure, existing leads should be reevaluated, (e.g., signal amplitudes, pacing thresholds, and impedance).
  • Page 56 Table 8. Lead measurements (continued) Pace/ sense lead Pace/ sense lead Shocking lead (acute (acute) (chronic) and chronic) R-Wave Amplitude > 5 mV > 5 mV > 1.0 mV P-Wave Amplitude > 1.5 mV > 1.5 mV b c d R-Wave Duration <...

  • Page 57: Step E: Form The Implantation Pocket

    Table 8. Lead measurements (continued) Pace/ sense lead Pace/ sense lead Shocking lead (acute (acute) (chronic) and chronic) Lead impedance (at > programmed Low > programmed Low Impedance Limit Impedance Limit 5.0 V and 0.5 ms left ventricle) (200–500 Ω) (200–500 Ω) <...
  • Page 58 tissue trauma and facilitate explant. However, deeper implantation (e.g., subpectoral) may help avoid erosion or extrusion in some patients. If an abdominal implant is suitable, it is recommended that implantation occur on the left abdominal side. If it is necessary to tunnel the lead, consider the following: WARNING: For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead.

  • Page 59: Step F: Connect The Leads To The Pulse Generator

    Step F: Connect the Leads to the Pulse Generator To connect leads to the pulse generator, use only the tools provided in the pulse generator sterile tray or accessory kit. Failure to use the supplied torque wrench may result in damage to the setscrews, seal plugs, or connector threads.
  • Page 60 • In models with a IS4-LLLL LV lead port, insert and secure the terminal pin of a IS4-LLLL lead. WARNING: When implanting a system which uses both a DF4-LLHH/LLHO and IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Inserting a lead into an incorrect port will result in unanticipated device behavior (potentially leaving the patient without effective therapy).
  • Page 61 CAUTION: Do not insert a lead into the pulse generator connector without taking the following precautions to ensure proper lead insertion: • Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into the port, to release any trapped fluid or air.
  • Page 62 CAUTION: Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation or connector damage. NOTE: If necessary, lubricate the lead connectors sparingly with sterile water to make insertion easier. NOTE: For IS-1 leads, be certain that the terminal pin visibly extends beyond the connector block at least 1 mm.

  • Page 63: Step G: Evaluate Lead Signals

    Step G: Evaluate Lead Signals Take the pulse generator out of power-saving Storage mode by programming the Tachy Mode to Off. CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device. For tachyarrhythmia detection and therapy, verify that the Tachy Mode is programmed to Monitor + Therapy.
  • Page 64 The High Impedance Limit is nominally set to 2000 Ω, and is programmable between 2000 and 3000 Ω in 250 Ω increments. The Low Impedance Limit is nominally set to 200 Ω, and is programmable between 200 and 500 Ω in 50 Ω increments. Consider the following factors when choosing a value for the High and Low Impedance Limits: •...

  • Page 65: Step H: Program The Pulse Generator

    Shocking lead impedance readings between 20 Ω and the programmed High Impedance Limit are considered in-range. If abrupt or large impedance fluctuations or out-of-range conditions are observed, consider the following: • Verify the configuration—ensure the programmed Shock Vector matches the configuration of the implanted lead (e.g., use RV Coil to Can with a single-coil lead).

  • Page 66: Step I: Test For Ability To Convert Ventricular Fibrillation And Inducible Arrhythmias

    Program the pulse generator appropriately if a lead port(s) is not used. Program the pulse generator to desired parameters appropriate for the patient for conversion testing. CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device.
  • Page 67 Induce the Patient’s Arrhythmia An arrhythmia can be induced by using the induction features of the pulse generator. Allow the patient’s blood pressure and electrophysiologic status to return to baseline between arrhythmia inductions, whether successful or unsuccessful. It is also suggested to allow a minimum of one minute between inductions.

  • Page 68: Step J: Implant The Pulse Generator

    To determine DFT, induce VF (or PVT or ventricular flutter if VF is not inducible). Attempt to convert the arrhythmia with a 31-J shock; if conversion is successful, then induce again and attempt to convert the arrhythmia at 29 J. Continue in this manner, decreasing the energy level until failure to convert VF occurs or 3 J is successful.

  • Page 69: Step K: Complete And Return The Implantation Form

    Close the implantation pocket. Consideration should be given to place the leads in a manner to prevent contact with suture materials. It is recommended that absorbable sutures be used for closure of tissue layers. Complete any electrocautery procedures before reactivating the pulse generator. Program the Tachy Mode to the desired setting and confirm final programmed parameters.
  • Page 70 This torque wrench is bidirectional, and is preset to apply adequate torque to the setscrew and will ratchet when the setscrew is secure. The ratchet release mechanism prevents overtightening that could result in device damage. To facilitate the loosening of tight extended setscrews, this wrench applies more torque in the counterclockwise direction than in the clockwise direction.

  • Page 71: Follow Up Testing

    20°–30° [1] Clockwise rotation to free setscrews stuck in the retracted position [2] Counterclockwise rotation to free setscrews stuck in the extended position Figure 8. Rotating the torque wrench to loosen a stuck setscrew FOLLOW UP TESTING It is recommended that device functions be evaluated with periodic follow-up testing by trained personnel. Follow up guidance below will enable thorough review of device performance and associated patient health status throughout the life of the device.

  • Page 72: Predischarge Follow Up

    Predischarge Follow Up The following procedures are typically performed during the predischarge follow up test using PRM telemetry: Interrogate the pulse generator and review the Summary screen. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals. Review counters and histograms. When all testing is complete, perform a final interrogation and save all the patient data.

  • Page 73: Explantation

    Review the Arrhythmia Logbook screen and for episodes of interest, print episode details and stored electrogram information. Clear the counters and histograms so that the most recent episode data will be displayed at the next follow-up session. NOTE: Echo-Doppler studies may be used to non-invasively evaluate AV Delay and other programming options post-implant.
  • Page 74 NOTE: Disposal of explanted pulse generators and/or leads is subject to applicable laws and regulations. For a Returned Product Kit, contact Boston Scientific using the information on the back cover. NOTE: Discoloration of the pulse generator may have occurred due to a normal process of anodization, and has no effect on the pulse generator function.
  • Page 75 • Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or lead, and send it to Boston Scientific.
  • Page 78 For additional technical reference guides, go to www.bostonscientific.com/ifu. Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112–5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2013 Boston Scientific Corporation or its affiliates. All rights reserved. 359049-002 EN US 2013-07 FCC ID: ESCCRMG17912 *359049-002*...

This manual is also suitable for:

Origen x4 crt-dDynagen x4 crt-dInogen crt-dInogen x4 crt-dG154G150 ... Show all

Table of Contents

Save PDF