PHYSICIAN’S TECHNICAL MANUAL* ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2, FORMIO™, VITALIO™, INGENIO™, ADVANTIO™ PACEMAKER Model L300, L301, L321, L310, L311, L331, L200, L201, L221, L210, L211, L231, L100, L101, L121, L110, L111, L131, S701, S702, S722, K278, K272, K273, K274, K172, K173, K174, K062, K063, K064 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 Information..................................................................................................................... Device Description.......................................................................................................................... Related Information ........................................................................................................................ Indications and Usage ..................................................
Implanting the Pulse Generator.................................................................................................... Step A: Check Equipment ................................................................................................ Step B: Interrogate and Check the Pulse Generator ........................................................ Step C: Implant the Lead System .....................................................................................
ADDITIONAL INFORMATION For additional reference information, go to www.bostonscientific.com/ifu.
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 2869 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
RELATED INFORMATION Refer to the lead’s instruction manual for implant information, general warnings and precautions, indications, contraindications, and technical specifications. Read this material carefully for implant procedure instructions specific to the chosen lead configurations. Refer to the PRM system Operator’s Manual or ZOOM Wireless Transmitter Reference Guide for specific information about the PRM or ZOOM Wireless Transmitter such as setup, maintenance, and handling.
INDICATIONS AND USAGE Boston Scientific pacemakers are indicated for treatment of the following conditions: • Symptomatic paroxysmal or permanent second- or third-degree AV block • Symptomatic bilateral bundle branch block • Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e.
Use of certain pacing modes and/or features available in these Boston Scientific pacemakers is contraindicated for the following patients under the circumstances listed: • Unipolar pacing or use of the MV Sensor with a Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) because it may cause inappropriate therapy or inhibition of appropriate S-ICD therapy.
• Separate pulse generator. 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 ("Minimizing Pacemaker/S-ICD Interaction" on page 21). • Safety Core operation. In response to applicable nonrecoverable or repeat fault conditions, the pulse generator will switch irreversibly to Safety Core operation.
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.
• Adaptive-rate modes. Adaptive-rate modes based completely or in part on MV might be inappropriate for patients who can achieve respiratory cycles shorter than one second (greater than 60 breaths per minute). Higher respiration rates attenuate the impedance signal, which diminishes the MV rate response (i.e., the pacing rate will drop toward the programmed LRL).
• Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets, and sources of EMI to avoid device damage. • 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.
• 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. • Dual chamber device without a functional RV lead.
• 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. Consider lead maturation in your choice of Pacing Amplitude, pacing Pulse Width, and Sensitivity settings. • • • An acute Pacing Threshold greater than 1.
• 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 programming a fixed AV Delay, consider the sensing outcomes. • MTR/MSR programming.
• High atrial rates. Sensing high atrial rates may impact device longevity. Therefore, the Atrial Sense lead configuration will be seeded to Off when programming from an atrial sensing mode to a non-atrial sensing mode. • Cross-chamber artifacts. Sensitivity adjustments associated with Smart Blanking may not be sufficient to inhibit detection of cross-chamber artifacts if the cross-chamber artifacts are too large.
• Sensitivity in unipolar lead configuration. The amplitude and prevalence of myopotential noise is increased in unipolar lead configurations, as compared to bipolar lead configurations. For patients with a unipolar lead configuration and myopotential oversensing during activity involving the pectoral muscles, the programming of Fixed Sensitivity is recommended. • Use of Patient Triggered Monitor.
Environmental and Medical Therapy Hazards • Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI. The pulse generator may inhibit pacing due to oversensing, or may switch to asynchronous pacing at the programmed pacing rate or at the magnet rate in the presence of EMI. 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 • • • 16 Mechanical ventilators. Program the MV Sensor to Off during mechanical ventilation. Otherwise, the following may occur: • Inappropriate MV sensor-driven rate • Misleading respiration-based trending 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 MV sensor to Off prior to performing external cardioversion or defibrillation. External defibrillation or cardioversion can damage the pulse generator.
• 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. In the presence of such interference, move the programmer away from electrical devices, and ensure that the wand cord and cables are not crossing one another.
• 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) and Security Systems.
• 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 real-time EGMs • Testing the leads (threshold, amplitude, and impedance) • Reviewing MV sensor-based diagnostics, MV sensor performance, and performing a manual MV sensor calibration if desired • Verifying battery status • Programming any permanent brady parameter to a new value and then reprogramming it back to the desired value • Saving all patient data • Verifying the appropriate final programming prior to allowing the patient to leave the clinic Minimizing Pacemaker/S-ICD Inter
In Safety Mode, these pulse generators use a unipolar pacing and sensing configuration. Safety Mode is compatible for use with an S-ICD because the configured parameters mitigate the potential pacemaker and S-ICD interactions as follows: • Sensing is AGC at 0.25 mV. The AGC sensing is able to effectively sense an intrinsic rhythm faster than the Safety Mode LRL of 72.5 bpm. As a result, pacing is inhibited and does not interfere with S-ICD tachyarrhythmia detection.
• Ventricular fibrillation and all of the patient’s ventricular tachycardias should be induced while the S-ICD is activated and the pacemaker is programmed to an asynchronous mode at maximum Amplitude and Pulse Width. This should provide the greatest opportunity for inhibition of arrhythmia detection due to detection of pacemaker pacing pulses. The pacemaker leads might have to be repositioned to eliminate detection of the pacing pulses by the S-ICD.
• 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. • End each TENS session by turning off the unit before removing the electrodes.
If electrocautery or RF ablation is medically necessary, observe the following to minimize risk to the patient and device: • Depending on the pacing needs of the patient, enable the Electrocautery Protection Mode, program to an asynchronous pacing mode, or use a magnet to switch to asynchronous pacing. An option for patients with intrinsic rhythm is to program the Brady Mode to VVI at a rate below the intrinsic rate to avoid competitive pacing.
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.
• • • • • • • • • • • • • • • • • • • • • • • Cardiac tamponade Chronic nerve damage Component failure Conductor coil fracture Death Elevated thresholds Erosion Excessive fibrotic tissue growth Extracardiac stimulation (muscle/nerve stimulation) Fluid accumulation Foreign body rejection phenomena Formation of hematomas or seromas Heart block Heart failure following chronic RV apical pacing Inability to pace Inappropriate pacing Incisional pain Incomplete lead connection with pulse generator Infection inclu
• • • • • • • • • • • • • • • • • • • • • 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) (Applies to dual-chamber devices only.
• • • Depression Fear of premature battery depletion Fear of device malfunction MECHANICAL SPECIFICATIONS The following mechanical specifications and material specifications apply to ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 devices. Table 2. Mechanical Specifications - All Pacemakers SR DR DR EL Case Electrode Surface Area (cm2) 29.10 28.92 35.05 Usable Battery Capacity (Ah) 1.0 1.0 1.6 Residual Usable Battery Capacity at Explant (Ah) 0.07 0.09 0.
Table 4. Table 5. Table 6. 32 Mechanical Specifications - ACCOLADE EL Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type L321 4.45 x 5.88 x 0.75 29.1 15.8 RA: IS-1; RV: IS-1 Mechanical Specifications - PROPONENT Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type L200 4.45 x 4.81 x 0.75 23.6 13.2 RA/RV: IS-1 L201 4.45 x 5.02 x 0.75 24.8 13.
Table 7. Table 8. Table 9. Mechanical Specifications - ESSENTIO Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) L100 4.45 x 4.81 x 0.75 23.6 13.2 RA/RV: IS-1 L101 4.45 x 5.02 x 0.75 24.8 13.7 RA: IS-1; RV: IS-1 Connector Type Mechanical Specifications - ESSENTIO EL Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type L121 4.45 x 5.88 x 0.75 29.1 15.
Table 10. Mechanical Specifications - ALTRUA 2 EL Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type S722 4.45 x 5.88 x 0.75 29.1 15.8 RA: IS-1; RV: IS-1 ACCOLADE, PROPONENT, and ESSENTIO devices include ZIP telemetry operating with a transmit frequency of 402 to 405 MHz.
Table 11. Mechanical Specifications - All Pacemakers (continued) SR DR DR EL Usable Battery Capacity (Ah) 1.05 1.05 1.47 Residual Usable Battery Capacity at Explant (Ah) 0.06 0.08 0.08 Mechanical specifications specific to each model are listed below. Table 12. Mechanical Specifications - FORMIO Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type K278 4.45 x 4.70 x 0.75 24.5 12.0 RA: IS-1; RV: IS-1 Table 13.
Table 14. Mechanical Specifications - VITALIO EL Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type K274 4.45 x 5.56 x 0.75 32.0 14.0 RA: IS-1; RV: IS-1 Table 15. Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type K172 4.45 x 4.57 x 0.75 23.5 11.5 RA/RV: IS-1 K173 4.45 x 4.70 x 0.75 24.5 12.0 RA: IS-1; RV: IS-1 Table 16.
