PHYSICIAN’S TECHNICAL MANUAL DYNAGEN™ CRT-D, INOGEN™ CRT-D, ORIGEN™ CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Model G150, G151, G154, G140, G141, G050, G051 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.
Table of Contents Additional Technical Information..................................................................................................... Device Description.......................................................................................................................... Related Information ........................................................................................................................ Intended Audience ............................................................
Implanting the Pulse Generator.................................................................................................... Step A: Check Equipment ................................................................................................ Step B: Interrogate and Check the Pulse Generator ........................................................ Step C: Implant the Lead System .....................................................................................
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.
• 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: • • • • • • One IS-11 atrial lead One LV-1 unipolar or bipolar left ventricular lead
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 Model Model Model 3120 3140 2868 6577 Programmer/Recorder/Monitor (PRM) ZOOM Wireless Transmitter ZOOMVIEW Software Application Accessory Telemetry Wand You can use the PRM system to do the following: • • • • • Interrogate the pulse generator Program the pulse generator to provide a variety of therapy options Access the pul
• Patients—A key component of the system is the LATITUDE Communicator, an easy-to-use, in-home monitoring device. The Communicator automatically reads implanted device data from a compatible Boston Scientific pulse generator at times scheduled by the physician. The Communicator sends this data to the LATITUDE secure server through a standard analog telephone line or over a cellular data network.
WARNINGS General • Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death. • For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.
• Handling the lead without Connector Tool. 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. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps.
Post-Implant • Protected environments. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. • Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning.
Sterilization and Storage • If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before final packaging. When the pulse generator and/or lead is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator and/or lead to Boston Scientific. • If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf package.
• Lead compatibility. 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. • Telemetry wand. Make sure a sterile telemetry wand is available should loss of ZIP telemetry occur. Verify that the wand can easily be connected to the programmer and is within reach of the pulse generator.
• Electrode connections. 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. • Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench to loosen the setscrew if necessary.
• Biventricular pacing therapy. This device is intended to provide biventricular pacing therapy. Programming the device to provide RV-only pacing, or programming the RV pace amplitude below the pacing threshold (resulting in LV-only pacing), is not intended for the treatment of heart failure. The clinical effects of LV-only or RV-only pacing for the treatment of heart failure have not been established. • Pacing and sensing margins.
• Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited by refractory periods. A long refractory period programmed in combination with a high MSR can result in asynchronous pacing during refractory periods since the combination can cause a very small sensing window or none at all. Use Dynamic AV Delay or Dynamic PVARP to optimize sensing windows. If you are entering a fixed AV Delay, consider the sensing outcomes. • Atrial Tachy Response (ATR).
• ATR exit count. Exercise care when programming the Exit Count to low values. For example, if the Exit Count was programmed to 2, a few cycles of atrial undersensing could cause termination of mode switching. • Proper programming without an atrial lead. If an atrial lead is not implanted (port is plugged instead), or an atrial lead is abandoned but remains connected to the header, device programming should be consistent with the number and type of leads actually in use.
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.
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. • • External patient monitors (e.g.
• 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. Avoid placing a pad (or paddle) directly over any subcutaneous leads. External defibrillation or cardioversion can damage the pulse generator.
• 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. • Electrical interference.
• 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 Telephone receivers if held within 1.27 cm (0.5 inches) of the pulse generator Magnetic wands such as those used for airport security and in the Bingo game • Electronic Article Surveillance (EAS).
• 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; certain countries may not have approval or capability to follow specific products.
• 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 • Programming any permanent brady parameter to a new value and then reprogramming it back to the desired value • Programming the Tachy Mode to a new value and then reprogra
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. If TENS is medically necessary outside the clinical setting (at-home use), provide patients with the following instructions: • Do not change the TENS settings or electrode positions unless instructed to do so.
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.
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.
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.
Table 1. Pressure Value Equivalencies (continued) Pressure value equivalencies a. b. Bar 5.0 kPa Absolute 500 All pressures were derived assuming sea water density of 1030 kg/m3. 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.
• • • • • • • • • • • • • • • • • • • • • • • 26 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 Foreign body rejection phenomena Formation of hematomas or seromas Heart block Inability to defibrillate or pace Inappropriate therapy (e.g.
• • • • • • • • • • • • • • • • • • • Lead perforation Lead tip deformation and/or breakage Local tissue reaction Myocardial infarction (MI) Myocardial necrosis Myocardial trauma (e.g.
• • • • 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: • • • • Allergic reaction to contrast media Breakage/failure of implant instruments Prolonged exposure to fluoroscopic radiation Renal failure from contrast media used to visualize coronary veins MECHANICAL SPECIFICATIONS All models have a case electrode surface are
Table 2. Mechanical Specifications - DYNAGEN CRT-Ds (continued) Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type G154 5.37 x 8.08 x 0.99 72.9 32.0 RA: IS-1; RV: IS-1/DF–1; LV: LV-1 G156 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 G158 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1; RV: DF4; LV: IS4 Table 3. Mechanical Specifications - INOGEN CRT-Ds Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type G140 5.37 x 8.18 x 0.99 73.
Table 3. Mechanical Specifications - INOGEN CRT-Ds (continued) Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type 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; RV: DF4; LV: IS4 Table 4. Mechanical Specifications - ORIGEN CRT-Ds Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type G050 5.37 x 8.18 x 0.99 73.6 32.5 RA: IS-1; RV: DF4; LV: IS-1 G051 5.37 x 8.08 x 0.99 72.8 32.
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 Product literature NOTE: Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilized or reused.
Table 5.
Table 5.
Table 5.
Table 5. Symbols on packaging (continued) Description Symbol 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.
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.
• Tachy Mode is programmed to: – – – Off 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.
2 1 3 [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. FEDERAL COMMUNICATIONS COMMISSION (FCC) This device complies with Title 47, Part 15 of the FCC rules.
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.
Table 7. Pulse generator life expectancy estimation (implant to explant) All Modelsa b Pacing Amplitude a. b. Longevity (years) at 500 Ω and 700 Ω Pacing Impedance (RV and LV) RA/RV LV 500 Ω 700 Ω 2.5 V 3.0 V 8.1 8.6 2.5 V 3.5 V 7.6 8.2 3.5 V 3.5 V 6.8 7.5 3.5 V 5.0 V 5.7 6.5 Assumes ZIP wandless telemetry use for 3 hours at implant time and for 40 minutes annually for in-clinic follow-up checks.
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. One hour of additional telemetry reduces longevity by approximately 7 days.
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 Sensing or pacing issues Inability to shock Error codes Loss of telemetry Refer to Boston Scientific’s CRM Product Performance Report on www.bostonscientific.
• Signs and symptoms of infection • Symptoms that should be reported (e.g.
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.
1 DF-1 IS-1 BI 5 2 – + RA RV LV LV-1 UNI/BI 6 DF-1 IS-1 BI 3 7 8 9 10 11 4 [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.
1 IS-1 BI 4 UNI/BI IS-1 LV DF4-LLHH RV 5 2 RA 6 3 7 [1] RA: White [2] LV: Green [3] RV: Red [4] RA (-) [5] LV (-) [6] Suture Holes [7] RV (-) Figure 4.
1 DF-1 IS-1 BI 5 2 – + RA RV LV IS4-LLLL 6 DF-1 IS-1 BI 3 7 8 9 10 11 4 [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.
1 DF-1 IS-1 BI 5 2 – + RA RV 6 DF-1 IS-1 BI LV IS-1 UNI/BI 3 7 8 9 10 11 4 [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.
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.
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.
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).
Table 8. Lead measurements (continued) R-Wave Amplitudea b Pace/ sense lead (acute) Pace/ sense lead (chronic) Shocking lead (acute and chronic) > 5 mV > 5 mV > 1.0 mV Amplitudea b > 1.5 mV > 1.5 mV R-Wave Durationb c d < 100 ms < 100 ms Pacing Threshold (right ventricle) < 1.5 V endocardial < 2.0 V epicardial < 3.0 V endocardial < 3.5 V epicardial Pacing Threshold (left ventricle) < 2.5 V coronary venous < 2.0 V epicardial < 3.5 V coronary venous < 3.
Table 8. Lead measurements (continued) Lead impedance (at 5.0 V and 0.5 ms left ventricle) a. b. c. d. e.
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.
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. Do not implant the pulse generator if the seal plugs appear to be damaged. Retain the tools until all testing procedures are complete and the pulse generator is implanted.
• 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). d. Defibrillation lead.
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. • Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench to loosen the setscrew if necessary.
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.
Step G: 1. 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. 2. Evaluate the pace/sense and defibrillation lead signals by viewing the real-time EGMs and markers.
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.
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).
4. Program the pulse generator appropriately if a lead port(s) is not used. 5. 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. For tachyarrhythmia detection and therapy, verify that the Tachy Mode is programmed to Monitor + Therapy.
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. During each arrhythmia induction, note the heart rate to determine the appropriate rate threshold values.
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. If the initial conversion at 31 J is unsuccessful, reposition the lead, or reverse polarity, or add an additional lead.
4. 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. 5. Complete any electrocautery procedures before reactivating the pulse generator. 6. Program the Tachy Mode to the desired setting and confirm final programmed parameters.
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.
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.
Predischarge Follow Up The following procedures are typically performed during the predischarge follow up test using PRM telemetry: 1. Interrogate the pulse generator and review the Summary screen. 2. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals. 3. Review counters and histograms. 4. When all testing is complete, perform a final interrogation and save all the patient data. 5. Print the Quick Notes and Patient Data reports to retain in your files for future reference.
4. Review the Arrhythmia Logbook screen and for episodes of interest, print episode details and stored electrogram information. 5. 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.
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. CAUTION: Be sure that the pulse generator is removed before cremation. Cremation and incineration temperatures might cause the pulse generator to explode.
• Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or lead, and send it to Boston Scientific.
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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.
