Table 17. Mechanical Specifications - ADVANTIO Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type K062 4.45 x 4.57 x 0.75 23.5 11.5 RA/RV: IS-1 K063 4.45 x 4.70 x 0.75 24.5 12.0 RA: IS-1; RV: IS-1 Table 18. Mechanical Specifications - ADVANTIO EL Pacemakers Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type K064 4.45 x 5.56 x 0.75 32.0 14.
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. SYMBOLS ON PACKAGING The following symbols may be used on packaging and labeling (Table 19 on page 38): Table 19.
Table 19.
Table 19.
Table 19.
Table 19. Symbols on packaging (continued) Description Symbol Uncoated device RF Telemetry CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment (Table 20 on page 42). Table 20.
The pulse generator is shipped in a power-saving Storage mode to extend its shelf life.
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.
(i.e., transmitters and receivers used to communicate weather data), the 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 21. Pulse generator life expectancy estimation (implant to explant) All Modelsa Longevity (years) at 500 Ω, 750 Ω, and 1000 Ω Pacing Impedance 500 Ω Pacing SR 750 Ω 1000 Ω DR DR EL SR DR DR EL SR DR DR EL A and V Amplitudes 3.5 V 50% 9.2 7.6 12.2 9.7 8.3 13.2 10.0 8.7 13.9 100% 7.9 5.9 9.5 8.6 6.8 10.9 9.1 7.4 11.8 A and V Amplitudes 2.5 V a. 50% 10.0 8.8 14.0 10.4 9.3 14.8 10.5 9.5 15.2 100% 9.2 7.6 12.1 9.7 8.2 13.2 10.0 8.7 13.
Longevities at an LRL of 70 ppm, 500 Ω, 0.5 ms, 100% paced, sensors On, and pacing mode most comprehensive are: SR models at 2.5 V = 8.6 years, at 5.0 V = 5.0 years; DR models at 2.5 V = 6.8 years, at 5.0 V = 3.0 years; DR EL models at 2.5 V = 10.9 years, at 5.0 V = 5.1 years. NOTE: The energy consumption in the longevity table is based upon theoretical electrical principles and verified via bench testing only.
• An additional 6 months in Storage mode prior to implant will reduce longevity by 80 days. Assumes implanted settings of 60 ppm LRL, 2.5 V pacing pulse Amplitude and 0.4 ms pacing Pulse Width; 500 Ω pacing Impedance; 100% pacing.
Table 22. Pulse generator life expectancy estimation (implant to explant) (continued) All Modelsa b Longevity (years) at 500 Ω, 750 Ω, and 1000 Ω Pacing Impedance 500 Ω a. b. 750 Ω 1000 Ω Pacing SR DR DR EL SR DR DR EL SR DR DR EL 50% 9.3 7.9 11.3 9.5 8.4 11.8 9.6 8.6 12.1 100% 8.5 6.9 9.8 8.9 7.5 10.7 9.2 7.9 11.
The pulse generator longevity may increase with a decrease in any of the following: • • • • Pacing rate Pacing pulse amplitude(s) Pacing pulse width(s) Percentage of paced to sensed events Longevity is also affected in the following circumstances: • • • • • • A decrease in pacing impedance may reduce longevity. When the MV Sensor is programmed Off for the life of the device, longevity is increased by approximately 5 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 • Signs and symptoms of infection • Symptoms that should be reported (e.g.
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.
IS–1 UNI/BI [1] RA/RV: White [2] RA/RV [3] Suture Hole Figure 2.
IS–1 RA IS–1 RV UNI/BI UNI/BI [1] RA: White [2] RV: White [3] RA [4] RV [5] Suture Hole Figure 3. Lead connections and setscrew locations, RA: IS-1, RV: IS-1 The following lead connections apply to FORMIO, VITALIO, INGENIO, and ADVANTIO devices. IS-1 UNI/BI [1] RA/RV [2] Suture Hole Figure 4.
IS-1 RA IS-1 RV UNI/BI UNI/BI [1] RA [2] RV [3] Suture Hole Figure 5. Lead connections and setscrew locations, RA: IS-1, RV: IS-1 NOTE: The pulse generator case is used as a pace electrode when the pulse generator has been programmed to a unipolar lead setting. IMPLANTING THE PULSE GENERATOR Implant the pulse generator by performing the following steps in the sequence provided. Some patients may require pacing therapies immediately upon connecting the leads to the pulse generator.
• • • • Sterile duplicates of all implantable items Sterile wand Sterile PSA cables Torque and non-torque wrenches During the implantation procedure, always have a standard transthoracic defibrillator with external pads or paddles available for use. Step B: Interrogate and Check the Pulse Generator To maintain sterility, test the pulse generator as described below before opening the sterile blister tray. The pulse generator should be at room temperature to ensure accurately measured parameters. 1.
3. If a unipolar pacing configuration is required at implant, program the Lead Configuration to Unipolar before implant. Step C: Implant the Lead System The pulse generator requires a lead system for pacing and sensing. 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. • Unipolar or bipolar atrial lead • Unipolar or bipolar right ventricular lead.
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). The use of radiography may help ensure lead position and integrity.
Table 23. Lead measurements (continued) Pace/ sense lead (acute) Pace/ sense lead (chronic) < 1.5 V endocardial < 3.0 V endocardial > programmed Low Impedance Limit (200–500 Ω) < 2000 Ω (or the programmed High Impedance Limit (2000–3000 Ω)) > programmed Low Impedance Limit (200–500 Ω) < 2000 Ω (or the programmed High Impedance Limit (2000–3000 Ω)) Pacing Threshold (atrium) Lead impedance (at 5.0 V and 0.5 ms atrium and right ventricle) a. b. c. d.
Step E: Form the Implantation Pocket Using standard operating procedures to prepare an implantation pocket, choose the position of the pocket based on the implanted lead configuration and the patient’s body habitus. Giving consideration to patient anatomy and pulse generator size and motion, gently coil any excess lead and place adjacent to the pulse generator. It is important to place the lead into the pocket in a manner that minimizes lead tension, twisting, sharp angles, and/or pressure.
Automatic Lead Detection Until a right ventricular lead is detected (or any appropriate lead in a single chamber device), the lead impedance is measured in both unipolar and bipolar configurations. Upon insertion of the lead into the header the impedance measurement circuit will detect an impedance which indicates that the device is implanted (automatic lead detection).
• b. In models with an IS-1 RV lead port, insert and secure the terminal pin of an IS-1 RV pace/sense lead. Right atrium. • In models with an IS-1 RA lead port, insert and secure the terminal pin of an IS-1 atrial pace/sense lead. 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 68): 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 EasyView 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.
f. Remove the torque wrench. g. Apply gentle traction to the lead to ensure a secure connection. h. If the lead terminal is not secure, attempt to reseat the setscrew. Reinsert the torque wrench as described above, and loosen the setscrew by slowly turning the wrench counterclockwise, until the lead is loose. Then repeat the sequence above. i. If a lead port is not used, insert a plug into the unused port and tighten the setscrew.
For FORMIO, VITALIO, INGENIO, and ADVANTIO devices, the High Impedance Limit is fixed at 2000 Ω. The Low Impedance Limit is nominally set to 200 Ω, and is programmable between 200 and 500 Ω in 50 Ω increments.
• When programming MTR, consider the patient’s condition, age, general health, sinus node function, and that a high MTR may be inappropriate for patients who experience angina or other symptoms of myocardial ischemia at higher rates. • When programming MSR, consider the patient’s condition, age, general health and that adaptive-rate pacing at higher rates may be inappropriate for patients who experience angina or other symptoms of myocardial ischemia at these higher rates.
WARNING: Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. 3. 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. 4. If Electrocautery mode was used during the implant procedure, cancel it when done. 5. Confirm final programmed parameters.
Scientific pulse generators and lead accessories that have setscrews that spin freely when fully retracted (these setscrews typically have white seal plugs). 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.
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.
2. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals. 3. 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. 6. Verify that important programmed parameter values (e.g.
• For other observation or complications reasons. 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.
• 74 Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or lead, and send it to Boston Scientific.
For additional reference information, 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 © 2014 Boston Scientific Corporation or its affiliates. All rights reserved.
