PHYSICIAN’S TECHNICAL MANUAL DYNAGEN™ EL ICD, DYNAGEN™ MINI ICD, INOGEN™ EL ICD, INOGEN™ MINI ICD, ORIGEN™ EL ICD, ORIGEN™ MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Model D150, D151 , D152, D153, D020, D021, D022, D023, D140, D141, D142, D143, D010, D011, D012, D013, D050, D051, D052, D053, D000, D001, D002, D003 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.
• 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 DF-1/IS-12 cardioversion/defibrillation lead One DF4
• • Model 2868 ZOOMVIEW Software Application Model 6577 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 pulse generator’s diagnostic features Perform noninvasive diagnostic testing Access therapy history data RELATED INFORMATION Refer to the lead’s instruction manual for implant information, general warnings and precautions, indications, contraindications, and
This device is designed to be LATITUDE enabled; LATITUDE availability varies by region. Refer to the LATITUDE Clinician Manual for more information. Intended Audience This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.
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.
• Magnet Response set to Inhibit Therapy. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the Magnet Response programming automatically will be set to Inhibit Therapy. When this happens, the patient should not apply the magnet because tachyarrhythmia therapy could be inhibited. PRECAUTIONS Clinical Considerations • Pacemaker-mediated tachycardia (PMT).
• Use by date. Implant the pulse generator and/or lead before or on the USE BY date on the package label because this date reflects a validated shelf life. For example, if the date is January 1, do not implant on or after January 2. Implantation • Expected benefits. Determine whether the expected device benefits provided by programmable options outweigh the possibility of more rapid battery depletion. • Evaluate patient for surgery.
• Do not bend the lead near the lead-header interface. 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. • Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. If a lead is not used, be sure to properly insert a plug in the unused port, and then tighten the setscrew onto the plug. • Electrode connections.
Device Programming • Device communication. Use only the designated PRM and software application to communicate with this pulse generator. • STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue to pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters will likely decrease device longevity. • 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. • Shock waveform polarity.
• 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. • Patients hear tones coming from their devices.
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. • 14 • 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 Bar 5.0 kPa Absolute 500 a. b. 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.
• • • • • • • • • • • • • • • • • • • • • • • Chronic nerve damage Component failure Conductor coil fracture Death 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 Heart failure following chronic RV apical pacing 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., tissue damage, valve damage) Myopotential sensing Oversensing/undersensing Pacemaker-mediated tachycardia (PMT) (Applies to dual-chamber devices only.
• • • • Fear of shocking while conscious Fear that shocking capability may be lost Imagined shocking Fear of device malfunction MECHANICAL SPECIFICATIONS All Extended Longevity (EL) ICD models have a case electrode surface area of 6192 mm². Usable battery capacity is 1.9 Ah and residual usable battery capacity at Explant is 0.12 Ah for single chamber devices and 0.12 Ah for dual chamber devices. Mechanical specifications specific to each model are listed below.
Table 3. Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) D020 (VR) 5.23 x 6.71 x 0.99 60.0 26.5 RV: DF4 D021 (VR) 5.23 x 7.14 x 0.99 61.9 28.5 RV: IS-1/DF–1 D022 (DR) 5.23 x 7.03 x 0.99 62.5 28.0 RA: IS-1; RV: DF4 D023 (DR) 5.23 x 7.14 x 0.99 62.3 28.5 RA: IS-1; RV: IS-1/DF–1 Table 4.
Table 5. Mechanical Specifications - INOGEN MINI ICDs Dimensions W x H x D (cm) Mass (g) Volume (cm3) D010 (VR) 5.23 x 6.71 x 0.99 60.0 26.5 RV: DF4 D011 (VR) 5.23 x 7.14 x 0.99 61.9 28.5 RV: IS-1/DF–1 D012 (DR) 5.23 x 7.03 x 0.99 62.5 28.0 RA: IS-1; RV: DF4 D013 (DR) 5.23 x 7.14 x 0.99 62.3 28.5 RA: IS-1; RV: IS-1/DF–1 Model Table 6.
Table 7. Mechanical Specifications - ORIGEN MINI ICDs Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) D000 (VR) 5.23 x 6.71 x 0.99 60.0 26.5 RV: DF4 D001 (VR) 5.23 x 7.14 x 0.99 61.9 28.5 RV: IS-1/DF–1 D002 (DR) 5.23 x 7.03 x 0.99 62.5 28.0 RA: IS-1; RV: DF4 D003 (DR) 5.23 x 7.14 x 0.99 62.3 28.5 RA: IS-1; RV: IS-1/DF–1 Models include ZIP telemetry operating with a transmit frequency of 402 to 405 MHz.
NOTE: Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilized or reused. SYMBOLS ON PACKAGING The following symbols may be used on packaging and labeling (Table 8 on page 31): Table 8.
Table 8.
Table 8.
Table 8.
Table 8. Symbols on packaging (continued) Description Symbol ICD RV Uncoated device CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment (Table 9 on page 35). Table 9.
Table 9. Characteristics as shipped (continued) Parameter Setting Pace/Sense Configuration RA: BI/BI (DR models) Pace/Sense Configuration RV: BI/BI The pulse generator is shipped in a power-saving Storage mode to extend its shelf life.
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: • • The letters, BSC, to identify Boston Scientific as the manufacturer The number, 140, to identify the Model 2868 PRM software application needed to communicate with the pulse generator The x-ray identifier is embedded in the header of the device.
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. Operation is subject to the following two conditions: • This device may not cause harmful interference, and • This device must accept any interference received, including interference that may cause undesired operation.
The longevity expectations, which account for the energy used during manufacture and storage, apply at the conditions shown in the table along with the following: • Assumes 60 ppm LRL, ventricular and atrial settings of 2.5 V pacing pulse Amplitude and 0.4 ms pacing pulse width; RA Impedance 500 Ω; sensors On. • Projected longevity is calculated assuming 3 maximum energy charging cycles per year, including automatic capacitor re-forms and therapeutic shocks.
Table 10. Extended Longevity (EL) ICD pulse generator life expectancy estimation (implant to explant) (continued) All Modelsa b Longevity (years) at 500 Ω, 700 Ω, and 900 Ω Pacing Impedance (RV) 500 Ω a. b. 700 Ω 900 Ω Pacing VR DR VR DR VR DR 50% 11.0 10.0 11.1 10.1 11.2 10.2 100% 10.3 9.0 10.6 9.2 10.8 9.3 Assumes ZIP telemetry use for 1 hour at implant time and for 40 minutes annually for in-clinic follow-up checks.
Table 11. MINI ICD pulse generator life expectancy estimation (implant to explant) (continued) All Modelsa b Longevity (years) at 500 Ω, 700 Ω, and 900 Ω Pacing Impedance (RV) 500 Ω a. b. 700 Ω 900 Ω Pacing VR DR VR DR VR DR 15% 5.4 5.1 5.4 5.1 5.5 5.1 50% 5.2 4.7 5.3 4.7 5.3 4.8 100% 4.9 4.2 5.0 4.3 5.1 4.4 Assumes ZIP telemetry use for 1 hour 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. For Extended Longevity (EL) devices, when the Respiratory Sensor is programmed Off for the life of the device, longevity is increased by approximately 4.5 months. For MINI devices, when the Respiratory Sensor is programmed Off for the life of the device, longevity is increased by approximately 2 months.
WARRANTY INFORMATION A limited warranty certificate for the pulse generator is available at www.bostonscientific.com. For a copy, contact Boston Scientific using the information on the back cover. 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.
PATIENT COUNSELING INFORMATION The following topics should be discussed with the patient prior to discharge. • External defibrillation—the patient should contact their physician to have their pulse generator system evaluated if they receive external defibrillation • Beeping tones—the patient should contact their physician immediately if they hear tones coming from their pulse generator • Signs and symptoms of infection • Symptoms that should be reported (e.g.
Patient Handbook The Patient Handbook is provided for each device. It is recommended that you discuss the information in the Patient Handbook 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. LEAD CONNECTIONS Lead connections are illustrated below. CAUTION: Prior to implantation, confirm the lead-to-pulse generator compatibility.
3 IS-1 RA DF4-LLHH RV BI 1 2 4 5 [1] RA: White [2] RV: Red [3] RA (-) [4] Suture Holes [5] RV (-) Figure 2. Lead connections and setscrew locations, RA: IS-1, RV: DF4-LLHH 2 1 DF4-LLHH RV 3 [1] RV: Red [2] RV (-) [3] Suture Holes Figure 3.
1 – + DF-1 IS-1 RV BI 5 2 DF-1 6 7 8 IS-1 RA BI 9 4 3 [1] Defib (-): Red [2] Defib (+): Blue [3] RA: White [4] RV: White [5] Defib (+) [6] Defib (-) [7] RA (-) [8] RV (-) [9] Suture Hole Figure 4.
1 DF-1 IS-1 BI 2 – + DF-1 4 5 6 RV 7 3 [1] Defib (-): Red [2] Defib (+): Blue [3] RV: White [4] Defib (+) [5] Defib (-) [6] RV (-) [7] Suture Hole Figure 5. Lead connections and setscrew locations, RV: IS-1/DF-1 NOTE: The pulse generator case is used as a defibrillating electrode unless the pulse generator has been programmed to the Distal Coil to Proximal Coil (or “Cold Can”) Shock Vector.
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. Verify the operational status of all equipment that may be used during the procedure.
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.
thresholds, and impedance). The use of radiography may help ensure lead position and integrity. If testing results are unsatisfactory, lead system repositioning or replacement may be required. • Connect the pace/sense lead(s) to a pacing system analyzer (PSA). 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.
Table 12. Lead measurements (continued) Pace/ sense lead (acute) Pace/ sense lead (chronic) Pacing Threshold (atrium) < 1.5 V endocardial < 3.0 V endocardial Lead impedance (at 5.0 V and 0.5 ms atrium and right ventricle)e > programmed Low Impedance Limit (200–500 Ω) < programmed High Impedance Limit (2000–3000 Ω) > programmed Low Impedance Limit (200–500 Ω) < programmed High Impedance Limit (2000–3000 Ω) a. b. c. d. e.
generator. It is important to place the lead into the pocket in a manner that minimizes lead tension, twisting, sharp angles, and/or pressure. Pulse generators are typically implanted subcutaneously in order to minimize 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.
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.
CAUTION: For IS-1/DF-1 leads, never change the shock waveform polarity by physically switching the lead anodes and cathodes in the pulse generator header—use the programmable Polarity feature. Device damage or nonconversion of the arrhythmia post-operatively may result if the polarity is switched physically. Connect each lead to the pulse generator by following these steps (for additional information about the torque wrench, refer to "Bidirectional Torque Wrench" on page 64): a.
Figure 6. d. Inserting the torque wrench With the torque wrench in place, fully insert the lead terminal into the lead port. The lead terminal pin should be clearly visible beyond the connector block when viewed through the side of the pulse generator header. Place pressure on the lead to maintain its position and ensure that it remains fully inserted in the lead port. CAUTION: Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface.
e. 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. f. Remove the torque wrench. g. Apply gentle traction to the lead to ensure a secure connection. h.
CAUTION: Take care to ensure that artifacts from the ventricles are not present on the atrial channel, or atrial oversensing may result. If ventricular artifacts are present in the atrial channel, the atrial lead may need to be repositioned to minimize its interaction. 3. Evaluate all lead impedances. CAUTION: If total shocking lead impedance during implant is less than 20 Ω, verify the proximal coil is not in contact with the pulse generator surface.
• For newly implanted leads, the starting measured impedance value NOTE: Depending on lead maturation effects, during follow-up testing the physician may choose to reprogram the High Impedance Limits. • Recommended impedance range for the lead(s) being used, if available • The impedance value of a high or maximum energy shock impedance test Shocking lead impedance readings between 20 Ω and the programmed High Impedance Limit are considered in-range.
Step H: Program the Pulse Generator 1. Check the Programmer Clock and set and synchronize the pulse generator as necessary so that the proper time appears on printed reports and PRM strip chart recordings. 2. It may be useful to program the Beep During Capacitor Charge feature to On during conversion testing and implantation to help recognize when the pulse generator is charging to deliver a shock. 3. Perform a manual capacitor re-formation if not already performed. 4.
If the conversion is unsuccessful, the patient should be rescued using an appropriate transthoracic defibrillator. Early conversion is important because a prolonged arrhythmia may be more difficult to terminate. WARNING: 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.
2. Verify magnet function and telemetry to ensure the pulse generator is within acceptable range. 3. Program the appropriate parameters and change the pulse generator Tachy Mode to Monitor + Therapy. 4. Perform the induction using the programmer. Determine DFT Defibrillation threshold (DFT) testing should be performed at implant to ensure adequate safety margins for the shock energy (safety margin = device maximum shocking energy minus DFT).
2. Verify magnet function and wanded telemetry to ensure the pulse generator is within acceptable range to initiate interrogation. 3. Ensure that the pulse generator has good contact with surrounding tissue of the implantation pocket, and then suture it in place to minimize device migration (for suture hole location illustrations, refer to "Lead Connections" on page 45). Gently coil excess lead and place adjacent to the pulse generator.
Complete the temporary patient identification card and give it to the patient. After receiving the validation form, Boston Scientific sends the patient a permanent identification card.
2. Rotate the wrench clockwise (for retracted setscrew) or counterclockwise (for extended setscrew) around the axis three times, such that the handle of the wrench orbits the centerline of the screw (Figure 7 on page 66). The torque wrench handle should not turn or twist during this rotation. 3. As needed, you may attempt this up to four times with slightly more angle each time. If you cannot fully loosen the setscrew, use the #2 torque wrench from Wrench Kit Model 6501. 4.
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 7. 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.
• 70 Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or lead, and send it to Boston Scientific.
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 © 2012 Boston Scientific Corporation or its affiliates. All rights reserved.
