St Jude Medical SJMRFB RF implantable medical device User Manual
St. Jude Medical RF implantable medical device
Users Manual
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 1093070 |
| Application ID | 0XqkzWb4dGal1K+jYVdv3Q== |
| Document Description | Users Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 36.67kB (458417 bits) |
| Date Submitted | 2009-04-08 00:00:00 |
| Date Available | 2009-08-15 00:00:00 |
| Creation Date | 2009-03-25 09:48:41 |
| Producing Software | Acrobat Distiller 8.1.0 (Windows) |
| Document Lastmod | 2009-03-25 10:07:35 |
| Document Title | untitled |
| Document Creator | FrameMaker 7.1 |
-- Draft -- User’s Manual Accent™ SR Model PM1110 SR RF Model PM1210 DR Model PM2110 DR RF Model PM2210 Pulse Generators Anthem™ Model PM3110 RF Model PM3210 Cardiac Resynchronization Therapy Device, Pulse Generator XXXX XXXX XXXX Reference Manual 1-1 -- Draft -- CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. Proposition 65, a State of California voter initiative, requires the following notice: WARNING: This product and its packaging have been sterilized with ethylene oxide. This packaging may expose you to ethylene oxide, a chemical known to the state of California to cause cancer or birth defects or other reproductive harm. © 2009 St. Jude Medical Cardiac Rhythm Management Division. All Rights Reserved. Unless otherwise noted, ® or ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical, Inc. or its subsidiaries. 1-2 -- Draft -Device Description This manual describes the following St. Jude Medical™ devices: Name Model Number Description Accent SR PM1110 Single-chamber pulse generator Accent SR RF PM1210 Single-chamber pulse generator with RF telemetry Accent™ DR PM2110 Dual-chamber pulse generator Accent DR RF PM2210 Dual-chamber pulse generator with RF telemetry Anthem™ PM3110 CRT-P pulse generator Anthem RF PM3210 CRT-P pulse generator with RF telemetry Table 1. Accent and Anthem device descriptions The pulse generator, along with compatible, commercially available leads, constitutes the implantable portion of the pulse generator and CRT-P systems. The lead systems are implanted using either transvenous or transthoracic techniques. These devices can be programmed with Merlin Patient Care System equipped with Model 3330 version 7.1 (or greater) software. For information on programming, refer to the programmer’s on-screen help. Indications and Usage Implantation of Anthem™ and Anthem RF devices is indicated for: • Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. • The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration. Implantation of Accent™, Accent RF, Anthem, and Anthem RF devices is indicated in one or more of the following permanent conditions: • Syncope • Presyncope • Fatigue • Disorientation Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 1-1 -- Draft -• Or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence,1 and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem, and Anthem RF devices only) is indicated for those patients exhibiting: • Sick sinus syndrome • Chronic, symptomatic second- and third-degree AV block • Recurrent Adams-Stokes syndrome • Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: • Normal sinus rhythm with only rare episodes of A-V block or sinus arrest • Chronic atrial fibrillation • Severe physical disability. AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. For specific indications associated with individual modes, refer to the programmer’s on-screen help. Contraindications Implanted Cardioverter-Defibrillator (ICD). Accent™, Accent RF, Anthem™, Anthem RF devices are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. 1. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 min-1 during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197 — (0.56 x age). Gwinn N, Leman R, Kratz J, et al. Chronotropic incompetence: A common and progressive finding in pacemaker patients. American Heart Journal 1992; 123:1216-19. Contraindications 1-2 Contraindications -- Draft -AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem, Anthem RF devices only) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem, Anthem RF devices only), though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help. Warnings and Precautions To prevent permanent damage to the device and tissue damage at the electrode/tissue interface: • Electrosurgery. Do not use electrosurgical devices in the vicinity of an implanted device. If electrocautery is necessary, use a bipolar cauterizer or place the indifferent electrode as far from the device as possible. • Lithotripsy. Do not focus a lithotripsy beam within 6 inches of the device. Program the device to Sensor Off prior to lithotripsy to prevent inappropriate increases in pacing rate. A thorough assessment of device function with special attention to the sensor should be performed following exposure to lithotripsy. • Therapeutic Radiation. Do not use ionizing radiation in the vicinity of an implanted device. Radiation therapy may damage the electronic circuitry of the device. • Ultrasound Treatment. Do not use therapeutic ultrasound within 6 inches of the device. • Ventricular Sensing. In Anthem™ and Anthem RF devices, Ventricular Sensitivity should be programmed to the highest setting (lowest sensitivity) that will provide ventricular sensing with adequate sensing margin. Left ventricular lead dislodgement, to a position near the atria, can result in atrial oversensing and ventricular inhibition. Perform a thorough assessment of device function following exposure to any of the above. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 1-3 -- Draft -Backup VVI Operation. In rare instances, the device may revert to Backup VVI operation at the programmed settings listed in Table 2. These values are not programmable. When the device has reverted to Backup VVI operation, the programmer displays a pop-up message indicating that the device is operating at the Backup VVI values. Press [Continue] and follow the on-screen instructions. Parameter Mode Base Rate Ventricular Pacing Chamber Value Accent™ Anthem™ VVI VVI 67.5 ppm 67.5 ppm NA LV —> RV Pulse Configuration Unipolar RV Unipolar Tip LV Unipolar Tip Sense Configuration Unipolar Tip RV Unipolar Tip Pulse Amplitude 5.0 V 5.0 V Pulse Width 0.6 ms 0.6 ms Refractory Period 337 ms 337 ms Sensitivity 2.0 mV 2.0 mV NA 16 ms Interventricular Delay Table 2. Backup VVI Settings Elective Replacement Indicator (ERI). At ERI, the nominal life of the device is three months. When the device exhibits signs of ERI, described on page 18, it should be replaced expeditiously. Patient follow-up visits should be scheduled at an appropriate frequency so that ERI can be detected well before End-of-Life (EOL). Noninvasive Programmed Stimulation (NIPS). Life-threatening ventricular tachycardia or fibrillation may occur during NIPS, therefore: (1) closely monitor the patient, and (2) make defibrillation and resuscitation equipment, and trained personnel, readily available during testing. Only physicians trained in tachycardia induction and reversion protocols should use NIPS. For more information on NIPS, refer to the programmer’s on-screen help. Ventricular Support Pacing during NIPS testing (Accent Model PM2110, Accent RF Model PM2210, Anthem, and Anthem RF devices only) is delivered Warnings and Precautions 1-4 Warnings and Precautions -- Draft -in the VOO mode. The specific indications and contraindications for VOO mode can be found on the programmer’s on-screen help. Precautions For single use only. Device Communication. Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If the problem persists, contact St. Jude Medical. Suboptimal RF Communication.2 The Merlin® PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the programmer and the Merlin Antenna. Below is a list of potential causes to suboptimal radio communication: Possible Causes Solutions The Merlin Antenna orientation/location is suboptimal. Move or reorient the Merlin Antenna slightly. Make sure that the front of the Merlin Antenna faces the implantable device. People or objects interfere with the communication between the Merlin Antenna and the device. Make sure that the space between the Merlin Antenna and the device is free from interfering objects/people. The Merlin Antenna is too far away from the device. Move the Merlin Antenna closer to the device. Someone is holding the Merlin Antenna. Place the Merlin Antenna on a flat surface. Do not hold the Merlin Antenna. Other products in the vicinity are causing electromagnetic interference (EMI). Power off or remove equipment that could cause EMI. The Merlin Antenna cable is wound around the Merlin Antenna. Make sure the Merlin Antenna cable is not wound around the Merlin Antenna. Table 3. Possible causes and solutions for suboptimal RF communication CT Scans. CT scans, due to their increased power levels and long exposure times, have the remote possibility of interfering with implanted devices. The potential interference is transient and occurs only when the X-ray signal is present. Continuous exposure may cause a temporary sensor rate increase. In 2. Available in Accent RF and Anthem RF devices only. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 1-5 -- Draft -addition, there is a remote possibility for a device to intermittently oversense while the CT scanning beam is directly over the implanted device. Sterilization, Storage and Handling Sterilization. The package contents have been sterilized with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Mechanical Shock. St. Jude Medical® devices are ruggedly constructed. However, if you suspect the device has been damaged, do not implant it; return it to St. Jude Medical. Temperature. Do not subject the pulse generator to temperatures above 50ºC (122ºF) or below –5ºC (23ºF). Exposure to temperatures below 0ºC may cause false ERI indications. Following exposure to extreme temperatures, warm the device to room temperature. If ERI indications are still present, return the pulse generator to St. Jude Medical. Incineration. Do not incinerate the device. Preparation for Implantation Package Label. Before opening the sterile package, carefully read the label and verify that the package contains the desired device. Verifying Operation. Before opening the sterile package, verify that the device is operating properly by interrogating it in the package. Remove the magnet and establish communication: • Inductive communication. Position the Merlin® PCS telemetry wand over the package and select “Interrogate.” • RF communication. To establish RF communication between the device and the programmer and to troubleshoot communications problems, you must first attach the RF Antenna to the programmer. Please refer to the Merlin™ Patient Care System User’s Manual that accompanies the programmer and the Merlin Antenna. Use the telemetry strength indicators to evaluate the communication. If the device is RF-compatible, an icon in the upper left-hand corner of the screen during the programming session indicates the status of the RF communication link. If an RF icon does not appear on the screen during the session, the device is not RF-compatible. Once you have established telemetery, select “Interrogate.” If The unit’s Measured Data will be displayed on the FastPath® Summary screen and should indicate normal voltage and battery status, and the programmed Sterilization, Storage and Handling 1-6 Sterilization, Storage and Handling -- Draft -parameters should be identical to the Shipped Settings displayed on the programmer’s on-screen help. Package Integrity. Ensure that the package has not been opened or in any way compromised. If damage is suspected, return it to the manufacturer. “Use Before” Date. Do not implant the device after the “use before” date printed on the label. Opening the Package. If interrogation of the device in its sterile packaging indicates normal functioning, remove it from the package. The package’s outer tray can be opened in nonsterile surroundings. However, when opening the inner tray, complete sterile technique must be observed. Pre-Implant Testing Compatible Pacing Leads. These devices accept unipolar or bipolar IS-1 short terminal pin leads. Use only St. Jude Medical® leads as the left ventricular lead in Anthem™ and Anthem RF devices. Prior to implantation, make sure leads fit easily and snugly into the device header. Pacing System Analyzer. Before implantation, you may wish to test the device using a compatible pacing system analyzer (PSA) with calibrated sensitivity and output settings. When the probe is attached to the device’s connector, the programmed parameters should be identical to the Shipped Settings displayed on the programmer’s on-screen help. Adaptor Probes. Use only IS-1 PSA cable adaptor probes when testing the device. Other probes may damage the connector. Capture/Sensing Thresholds. Capture and sensing thresholds should be determined with a PSA before implanting the device. Connect the negative (black) PSA terminal to the portion of the lead terminal pin corresponding to the tip electrode. The positive (red) terminal should be connected to the ring electrode portion of the lead pin for bipolar leads or to an indifferent electrode. For more information on conducting capture and sensing threshold tests, please consult the PSA technical manual. Establishing Baseline Ventricular Capture/Sensing Thresholds (Anthem, Anthem RF devices). After the leads have been implanted and before they are connected to the device, separately identify and document the baseline morphology for capture and sensing thresholds for each ventricular lead. Once baselines are established, determine if the ECG or IEGM recordings can help discriminate biventricular capture, and negative depolarizations for each lead. In a cardiac resynchronization therapy system, the ECG may display two distinct capture loss morphologies, because the left and right chambers often have different pacing thresholds. To ensure that the device is losing capture on both sides of the heart, allow the test to run until a marked change in morphology occurs, indicating capture loss on both sides. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 1-7 -- Draft -Implantation Ventricular Leads with Polished Platinum Tip Electrodes (Anthem™ and Anthem RF devices only). Pairing a ventricular lead with a polished platinum tip electrode with a ventricular lead with a tip electrode of a different material may create a source impedance mismatch that could adversely affect sensing. Data Transmission. Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it. Case Markings. Examine the markings on the device case and verify proper atrial and ventricular connection. Setscrew. Exercise caution when turning the setscrew, which may be backed out of the connector if turned counter-clockwise for more than two rotations. Programming Programmer. These devices can be interrogated and programmed with the Merlin® Patient Care System equipped with Model 3330 version 7.1 (or greater) software. For a list of programmable parameters and their programmable values, refer to the programmer’s on-screen help. Setting Lead Type. When you interrogate the device for the first time, the programmer will prompt you to set the Lead Type. (In Anthem™ and Anthem RF devices, the right and left ventricular lead types are independently set.) Because some parameters are determined by the Lead Type (for example, Pulse Configuration), you should set this parameter when the device is implanted. Lead Impedance Values. In Anthem and Anthem RF devices, independent lead impedance values are displayed for the RV and LV leads. Ventricular Pulse Amplitudes and Pulse Widths. In Anthem and Anthem RF devices, the right and left ventricular pulse amplitudes and pulse widths are independently programmable. The pulse amplitude should be evaluated in each chamber accordingly. Typically, capture thresholds are higher in the left ventricle. Follow-up Capture Threshold Measurements. In Anthem and Anthem RF devices, the RV and LV capture threshold measurements are evaluated independently. During an RV or LV capture test, you may be able to determine when capture is occurring by noting changes in the ECG morphology. For additional information, refer to the programmer’s on-screen help. AOO(R), VOO(R), and DOO(R) Modes are primarily intended for temporary diagnostic use. Long-term use may result in competitive pacing, inducing potentially dangerous arrhythmias. Implantation 1-8 Implantation -- Draft -Off mode is not recommended for patients who would be adversely affected by even a short cessation of device function. Pulse Amplitude. If the AutoCapture™ Pacing System or Cap Confirm are not in use, determine the capture threshold before programming the Pulse Amplitude. Program Pulse Amplitude to yield a suitable safety margin for reliable, long-term capture. Reassess capture thresholds periodically. Noninvasive Program Stimulation (NIPS). Atrial or ventricular tachycardia or fibrillation may occur during NIPS. Therefore, (1) closely monitor the patient, and (2) have emergency equipment for cardioversion/defibrillation readily available while conducting NIPS. High-Output Settings. Programming high-output settings or a high Base Rate may shorten the time to ERI. Runaway Protection. Hardware circuitry in the device prevents it from stimulating at rates higher than 210 min-1 (± 10 min-1). Sensing Configuration. Sensing tests should be performed whenever changes are made to the sensing configuration. Sensitivity Settings. Careful consideration should be given to patient exposure to electromagnetic interference if programming sensitivity greater than 0.5 mV with a bipolar sense configuration setting and 2.0 mV with a unipolar sense configuration setting. Environmental and Medical Therapy Hazards St. Jude Medical™ devices are equipped with special shielding and filters which significantly reduce the adverse effects of electromagnetic interference (EMI) on the operation of the device. Patients should be directed to exercise reasonable caution in avoidance of strong electric or magnetic fields. If the device inhibits or reverts to asynchronous operation while in the presence of electromagnetic interference (EMI), the patient should move away from the EMI source or turn the source off. Advise patients to seek medical guidance before entering environments which could adversely affect the operation of the device, including areas protected by a warning notice preventing entry by pacemaker patients. Medical Procedures and Environments In general, pacemaker patients should not be exposed to hospital equipment that produces high electromagnetic field strength signals, such as diathermy machines and electrosurgical units. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 1-9 -- Draft -• External Defibrillation. The electronic circuitry in the device provides protection from defibrillation discharges. Nevertheless, do not place defibrillator paddles directly over the device or pacing lead. Following defibrillation, ensure that the device is operating correctly. • Magnetic Resonance Imaging (MRI). MRI for patients with implantable devices has been contraindicated by MRI manufacturers. Clinicians should carefully weigh the decisions to use MRI with pacemaker patients. Additional safety concerns include: - Magnetic and RF fields produced by MRI may increase pacing rate, inhibit pacing, cause asynchronous pacing or result in pacing at random rates - MRI may result in changes in capture thresholds due to heating of pacing leads - MRI may irreversibly damage the device - Patients should be closely monitored during the MRI - Assess the device function before and after exposure to MRI. • Ionizing Radiation. Therapeutic ionizing radiation (for example, used in linear accelerators and cobalt machines) can permanently damage the device’s circuitry. The effect of ionizing radiation is cumulative; the potential for damage to the device is proportional to the patient’s total radiation dosage. If the patient must be exposed to ionizing radiation, protect the device during the procedure with local radiation shielding. If tissue near the implant site must be irradiated, it may be necessary to move the device to another area. Before and after exposure to radiation, evaluate the device operation to identify any adverse consequences. • Transcutaneous Electrical Nerve Stimulation (TENS). To reduce the possibility of interference with device function, place the TENS electrodes close to one another and as far from the device as possible. Before allowing unrestricted use of TENS in a home or other setting, screen the patient in a monitored environment for possible interaction. • Therapeutic Diathermy. Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may permanently damage the device. • Electrosurgical Cautery can induce ventricular arrhythmias and/or fibrillation or may cause asynchronous or inhibited device operation. If use of electrocautery is necessary, the current path and ground plate should be kept as far away from the device and leads as possible. A bipolar cauterizer may minimize these effects. Following electrocautery, conduct a thorough assessment of the device. • RF Ablation. Radiofrequency (RF) ablation in patients with a device may cause any of the following: asychronous pacing above or below the programmed rate; reversion to an asynchronous operation; device electrical reset; or premature triggering of the elective replacement indicator. 10 Environmental and Medical Therapy Hazards 1-10 Environmental and Medical Therapy Hazards -- Draft -RF ablation risks may be minimized by: programming a non-rate responsive, asynchronous pacing mode prior to the RF ablation procedure; avoid direct contact between the ablation catheter and the implanted lead or device; positioning the ground plate so that the current pathway does not pass through or near the device system, i.e., place the ground plate under the patient’s buttocks or legs; having a programmer available; or having external defibrillation equipment available. Patient Environment High-Voltage transmission lines and equipment, arc or resistance welders, induction furnaces, and similar equipment may generate substantial EMI fields that may interfere with device operation. Communication Equipment, such as microwave transmitters,3 linear power amplifiers, or high-power amateur transmitters may generate sufficient EMI to interfere with the operation of the device. Advise patients to move away from this equipment to resume normal device operation. Home Appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with device operation. Electric vibrators, razors, and handtools held directly over the device may disturb its operation. Twiddler’s Syndrome. Caution patients against manipulating the implanted device since it may result in lead damage or lead displacement. Patient Activities. Any activities that involve repetitive impacts or jarring (such as horseback riding, jackhammer use, etc.) may increase the pacing rate when the device’s Sensor is programmed On. Caution patients against such activity and program Sensor parameters with these activities in mind. Electronic Article Surveillance (EAS). Advise patients that the Electronic Article Surveillance/Anti-theft systems or Electronic Article Surveillance (EAS) systems such as those at the point of sale and entrances/exits of stores, libraries, banks, etc., emit signals that may interact with pacemakers and CRT-Ps. It is very unlikely that these systems will interact with their device significantly. However, to minimize the possibility of interaction, advise patients to simply walk through these areas at a normal pace and avoid lingering near or leaning on these systems. No Pacer Symbol. Caution patients implanted with this device to avoid areas marked with the NO PACER symbol. 3. Home appliance microwave ovens do not interfere with device operation. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 11 1-11 -- Draft -- Figure 1. No Pacer Symbol Cellular Phones. A St. Jude Medical-designed protective filter in Accent™, Accent RF, Anthem™, and Anthem RF devices prevents cellular phone-generated electromagnetic signals from interfering with the operation of the device.4 The device has also been tested for compatibility with handheld wireless transmitters in accordance with the requirements of AAMI PC69. This testing covered the operating frequencies (450 MHz - 3 GHz) and pulsed modulation techniques of all of the digital cellular phone technologies in worldwide use today. For more information, you or your patient may wish to contact Technical Service (page 19). Explantation Do not reuse explanted devices and leads. Clean explanted equipment with +1% sodium hypochlorite, rinse with water, dry. Return the explanted device to the manufacturer. Explant the device before cremation of a deceased patient. Hex wrenches are available for disconnecting a previously implanted device from the indwelling leads. To obtain the wrenches, contact your local St. Jude Medical representative. Potential Adverse Events The following are potential complications associated with the use of any pacing system: • Air embolism • Body rejection phenomena • Cardiac tamponade or perforation 4. Carrillo R, Williams DB, Traad EA, Schor JS. Electromagnetic filters impeded adverse interference of pacemakers by digital cellular telephones. JACC 1996; 27(2A):15A Abstract 901-22. 12 Explantation 1-12 Explantation -- Draft -• Hematoma, bleeding hematoma, seroma • Formation of fibrotic tissue, local tissue reaction • Inability to interrogate or program due to programmer or device malfunction • Infection/erosion • Interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic • Lead malfunction due to conductor fracture or insulation degradation • Loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface • Loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation) • Loss of normal device function due to battery failure or component malfunction • Pacemaker migration or pocket erosion • Pectoral muscle or diaphragmatic stimulation • Phrenic nerve stimulation • Pneumothorax/hemothorax • Device migration and pocket erosion • Endocarditis • Excessive bleeding • Induced atrial or ventricular arrhythmias • Myocardial irritability • Pericardial effusion • Pericardial rub • Pulmonary edema • Rise in threshold and exit block • Valve damage • Cardiac/coronary sinus dissection (Anthem, Anthem RF devices only) • Cardiac/coronary sinus perforation (Anthem, Anthem RF devices only) • Coronary sinus or cardiac vein thrombosis (Anthem, Anthem RF devices only) Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 13 1-13 -- Draft -Clinician Use Information WARNING The default Atrial Sensitivity setting and the lowest possible setting of Ventricular Sensitivity, 0.2 mV, may be more susceptible to EMI, according to testing required by CENELEC standard prEN45502-2-2. The devices comply with the electromagnetic compatibility requirements of CENELEC standard prEN45502-2-2 at atrial and ventricular sensitivities of 0.3 mV and less sensitive settings. Programming Guidelines General For a list of all programmable parameters and settings, refer to the programmer’s on-screen help. Magnet Use To interrogate the device, remove the magnet from the programmer telemetry wand. A magnet will interfere with proper telemetry. Temporary Programming These devices feature Temporary Programming to aid the clinician in diagnosing and treating the patient. The clinician can temporarily program parameters to assess their effects with the ability to quickly cancel or permanently program the setting. For more information, refer to the programmer’s on-screen help. Preset Programmed Settings Shipped Settings The device’s parameter settings are preset when the device is manufactured. For additional information, refer to the programmer’s on-screen help. 14 Clinician Use Information 1-14 Clinician Use Information -- Draft -Emergency Settings The device is equipped with standard, high-output settings that can be quickly programmed using the programmer’s Emergency VVI function. Settings for Emergency VVI can be found in the programmer’s on-screen help. Note When Emergency VVI is selected, diagnostic data are cleared from memory without a warning. Radiopaque Identification Each device has an X-ray absorptive marker for noninvasive identification. The marker consists of the St. Jude Medical logo (SJM) and a two-letter model code. (See Table 4.) Device Model X-ray ID Model Code PM1110, PM1210, PM2110, PM2210, PM3110, PM3210 HI Table 4. X-ray ID codes for Accent™, Accent RF, Anthem™, Anthem RF devices Implantation and Lead Connection Package Contents Devices are shipped in a sterile box containing: • One device • Two IS-1 header plugs for sealing unused ports (Anthem™, Anthem RF devices only) • Connector kit containing: - Torque wrench • Literature. Lead Connection These devices accept unipolar or bipolar IS-1 short terminal pin leads. Prior to implantation, make sure leads fit easily and snugly into the device header. These devices have a single setscrew for each lead pin. The setscrew makes Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 15 1-15 -- Draft -contact with the pin (cathode) securing the lead within the connector while an annular spring makes contact with the proximal ring (anode). Note Enter the lead types for each lead on the Patient Information screen. For additional information, refer to the programmer’s on-screen help. CAUTION After all leads have been implanted and before they are connected to the device, establish and document the baseline morphology for capture and sensing thresholds for each lead using a suitable recording system, such as a 12-lead ECG or Intracardiac Electrogram (IEGM) CAUTION In Anthem™ and Anthem RF devices, pairing a ventricular lead with a polished platinum tip electrode with a lead with a tip electrode of a different material may create a source impedance mismatch that could adversely affect sensing. Use only St. Jude Medical™ leads as the left ventricular lead in Anthem and Anthem RF devices. To connect the device to the leads: 1. Remove blood and body fluids from the terminal pins of the implanted leads. 2. Check the markings on the device case and verify proper atrial and ventricular connections. CAUTION Exercise caution when turning the setscrew, which may be backed out of the connector if turned counterclockwise for more than two rotations. 16 Implantation and Lead Connection 1-16 Implantation and Lead Connection -- Draft -3. Note In Anthem and Anthem RF devices: For proper sensing and pacing, it is important to ensure that left and right ventricular signals are correctly detected and that pacing pulses are delivered in the desired chamber. 4. Use the torque wrench packaged with the device to retract the setscrews in the device connector so that the pacing lead terminal pins can be fully inserted. 5. Insert the lead pin firmly into the connector until it is immobile and visible in the viewport at the opposite end of the connector. 6. Insert the torque wrench through the aperture on the header and into the setscrew on the side of the connector. 7. Turn the torque wrench clockwise until it clicks. The wrench is torque-limited and will not allow excessive tightening. 8. Repeat Steps 5 through 7 for additional lead(s). 9. Tug gently on the leads to ensure they are securely connected to the device. In order to minimize device migration, secure the device to the subcutaneous pocket via the suture hole in the device header. After the device has been implanted and the pocket is closed, interrogate the device and set the Lead Type to the correct setting. Lead Type settings are described on the programmer’s on-screen help. Note In Anthem and Anthem RF devices, the right and left ventricular pulse amplitudes and pulse widths are independently programmable. The pulse amplitude and pulse width should be evaluated in each chamber accordingly. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 17 1-17 -- Draft -Note Careful consideration should be given to patient exposure to electromagnetic interference if programming sensitivity greater than 0.5 mV with a bipolar sense configuration setting and 2.0 mV with a unipolar sense configuration setting. Note In Anthem and Anthem RF devices, independent lead impedance values are displayed for the RV and LV leads. Device Registration An Implantable Device Registration Form is enclosed with each device to serve as a permanent record of information pertaining to the implanted device. The completed original should be returned to the manufacturer in the postagepaid, addressed envelope provided. Copies of the registration form are provided for the hospital and the physician. Device Longevity For estimated longevity calculations, see the programmer’s on-screen help. Elective Replacement Indicator ERI (or Recommended Replacement Time) is the point at which battery voltage has dropped to the lowest capacity that will maintain adequate device operation for a nominal period of three months before EOL. When the device reaches ERI, a number of indicators alert the clinician to this condition. For information on these conditions, refer to the programmer’s onscreen help. Clearing ERI When the programmer displays a message that the device has reached ERI, you are able to clear ERI. For additional information on Clearing ERI, refer to the programmer’s on-screen help. 18 Device Registration 1-18 Device Registration -- Draft -CAUTION Programming to high output settings with a high Base Rate may shorten the time to ERI. Programming to lower rates and outputs may restore normal battery status. If the programmer displays an ERI warning message, the clinician should fully evaluate the device. WARNING At ERI, the nominal life of the device is three months. When the device exhibits signs of ERI (described on the programmer’s onscreen help), it should be replaced expeditiously. End-of-Life End-of-Life (EOL) occurs when the battery voltage has fallen to approximately 2.5 V. For additional information, refer to the programmer’s on-screen help. Technical Service St. Jude Medical Cardiac Rhythm Management Division maintains 24-hour phone lines for technical questions and support: • 1 818 362 6822 • 1 800 722 3774 (toll-free within North America) • + 46 8 474 4147 (Sweden) For additional assistance, call your local St. Jude Medical representative. Additional Information For additional information on this device, refer to the programmer’s on-screen help. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 19 1-19 -- Draft -Physical Specifications PM1110 PM2110 PM1210 PM2210 Case Material Titanium Titanium Titanium Titanium Case Coating None None None None RF Antenna Material None None Titanium Titanium Connector Material Epoxy Epoxy Epoxy Epoxy Dimensions1 (mm) 42(h) x 52(l) x 6(t) 46(h) x 52(l) x 6(t) 52(h) x 52(l) x 6(t) 52(h) x 52(l) x 6(t) Weight 1 (g) 18 19 23 23 Volume2 (cm3) 9.5 10.5 12.8 12.8 Lead Connector IS-13 IS-1 3 IS-1 3 IS-1 3 Table 5. Accent™, Accent RF physical specifications 1. These values are nominal. 2. ± 0.5 cm3 3. Accepts IS-1 short terminal pin leads. PM3110 PM3210 Case Material Titanium Titanium Case Coating None None RF Antenna Material None Titanium Connector Material Epoxy Epoxy Dimensions1 (mm) 52(h) x 52(l) x 6(t) 58(h) x 52(l) x 6(t) Weight 1 (g) 21 25 Volume2 (cm3) 11.5 13.7 Lead Connector IS-13 IS-1 3 Table 6. Anthem™, Anthem RF devices physical specifications 1. These values are nominal. 2. ± 0.5 cm3 3. Accepts IS-1 short terminal pin leads. 20 Physical Specifications 1-20 Physical Specifications -- Draft -Battery Information PM1110, PM2110, PM3110 Power source 1 QMR cell Manufacturer Wilson Greatbatch Ltd. USA Model 2662 Voltage at BOL 3.2 V Voltage at ERI 2.6 V Table 7. Battery Information RF Operating Frequencies Nearby equipment emitting strong magnetic fields can interfere with RF communication, even if the other equipment complies with CISPR emission requirements. The operating characteristics are as follows: MICS band: 402-405 MHz. The effective radiated power is below the limits as specified in: • Europe: EN ETSI 301 839-2 • USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219. • FCC ID: RIASJMRFB. Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 21 1-21 -- Draft -WARNING This transmitter is authorized by rule under the Medical Implant Communications Service (part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids (that is, 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 aids, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. Temperature Effects Parameter1 at 20°C at 43°C Base Rate < ± 1% < ± 1% Test Rate < ± 1% < ± 1% Pulse Width < ± 1% < ± 1% Pulse Amplitude < ± 5% < ± 2% Sensitivity < ± 5% < ± 2% Table 8. Maximum Temperature Effect on Different Parameters 1. Parameter value deviation from 37°C. 22 Temperature Effects 1-22 Temperature Effects -- Draft -- Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual XXXX XXXX XXXX Reference Manual 23 1-23 -- Draft -- 24 Temperature Effects 1-24 Temperature Effects -- Draft -- -- Draft -- Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 Veddestavägen 19 SE-175 84 Järfälla Sweden +46 8 474 4000 701 E. Evelyn Avenue Sunnyvale, CA 94086 USA +1 408 738 4883 January 2009 Art 60020471/A
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : No Encryption : Standard V2.3 (128-bit) User Access : Print, Annotate, Fill forms, Extract, Print high-res Page Mode : UseOutlines XMP Toolkit : Adobe XMP Core 4.0-c316 44.253921, Sun Oct 01 2006 17:14:39 Creator Tool : FrameMaker 7.1 Modify Date : 2009:03:25 10:07:35-07:00 Create Date : 2009:03:25 09:48:41Z Metadata Date : 2009:03:25 10:07:35-07:00 Format : application/pdf Title : untitled Producer : Acrobat Distiller 8.1.0 (Windows) Document ID : uuid:8e4da22f-2bcc-47c0-aa39-9d7478404288 Instance ID : uuid:b4c43521-8127-4674-ba2c-ab0675c9a487 Has XFA : No Page Count : 28 Creator : FrameMaker 7.1EXIF Metadata provided by EXIF.tools