FCC ID: RIASJMRFB RF Implantable Medical Device

RF, Assurity

+, Endurity Pulse Generator Cardiac Resynchronization Therapy Pulse Generator USERS MANUAL ST. JUDE MEDICAL MoE CONTROL, LESS RISK. Proposition 65, a State of Calli fornia 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. ST. JUDE MEDICAL, the nine Squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. CAUTION: Federal (USA) law restri cts this device to sale by or on the order of a physician. 2012 St. ude Medical Cardiac Rhythm Management Division. All Rights Reserved. Unless otherwise noted, or indicates that the name is a trademark of, or licensed to, St. ude Medical, Inc. or its Subsidiaries. Device Description This manual describes the St. Jude Medical pulse generators listed in the table below. The pulse generator, along with compat ible, 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 SscalslalM Otol as, System (PCS) equipped with Model 3330 version 17.1.1 (or greater) software. For information on programming, refer to the programmer's on screen help. Table 1. Pulse generator descriptions Model Number Connector PM1110 chamber pulse generator PM1160 chamber pulse generator Accent SR RF PM1210 chamber pulse generator with RF Rod (olAAIolaAY, chamber pulse generator with RF Rod (olAAIolaAY, Table 1. Pulse generator descriptions Model Number Connector PM1260 amber pulse generator with RF Rod (olAAIolaAY, PM2110 chamber pulse generator PM2160 chamber pulse generator Accent DR RF PM2210 chamber pulse generator with RF Rod (olAAIolaAY, chamber pulse generator with RF Rod (olAAIolaAY, PM2260 chamber pulse generator with RF Rod (olAAIolaAY, PM3110 PM3120 PM3210 P with RF telemetry Table 1. Pulse generator descriptions Model Number Connector P with RF telemetry P with RF telemetry Indications and Usage Implantation of a CRT P is indicated for:

Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nod ablation for chronic atrial fibrillation and have NYHA Class II or Ill 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 thera py, and have a left ventricular ejection fraction 35% and a prolonged QRS duration. Implantation of a single chamber pulse generator, dual chamber pulse generator, or CRT P is Indicated in one or more of the following permanent conditions:

Or any combination of those symptoms. Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who ould benefit from increased stimulation rates concurrent with physical activity. Chronotrop 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 bom during exe rcise testing, whichever is less, where the age predicted heart rate is calculated as 197

(0.56 x age). Chamber Pacing

(Dual chamber pulse generators, CRT Ps) is indicated for those patients exhibiting:

Sick sinus syndrome Chronic, symptomatic secon degree AV block Recurrent Adams Stokes syndrome Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraven conduction systems. Gwinn N, Leman R, Kratz J, et al. Chronotropic incompetence: A common and progressive finding in pacemaker patients. American Heart Journal 1992; 123:121619. 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 chamber pulse generators, CRT Ps) stimulation 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) chamber pulse generators, dual chamber pulse generators, and CRT Ps are contraindicated in patients with an implanted cardioverter defibrillat 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. AF Suppression

(Dual chamber pulse generators, CRT Ps) stimulation is not recommended in patients who cannot tolerate high atrial rate stimulation. Chamber Pacing

(Dual chamber pulse generators, CRT Ps), though not co ntraindicated 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. Chamber Ventricular Demand Pacing is relatively contraindicated in pa tients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated ompromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer's on 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 lithotrip sy 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 Sure 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 o f the device. Ventricular Sensing. In CRT Ps, 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 nea r the atria, can result in atrial oversensing and ventricular Inhibition. Perform a thorough assessment of device function following exposure to any of the above. Backup VVI Operation

. In rare instances, the device may revert to Backup VVI operation at the listed in the table below. 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 fo llow the on screen instructions. Backup VVI Settings Parameter Chamber Pulse Generators Chamber Pulse Generators Backup VVI Settings Parameter Chamber Pulse Generators Chamber Pulse Generators Ventricular Pacing Chamber ae nels Pulse Configuration alielellamnle LV Unipolar Tip sense Configuration Unipolar Tip RV Unipolar Tip Pulse Amplitude Pulse Width Refractory Period Tov aIsaiaNVAIN Interventricular Delay Elective Replacement Indica

), the nominal life of the device is three or six months. When the device exhibits signs of ERI it should be replaced expeditiously. Patient follow up visits should be scheduled at an appropriate frequency so that ERI can be detected ell before End Life (EOL). CoD TEAN TA oe a cere UOMO ETUC a ON Led E 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

(Dual chamber pulse generators, CRT Ps) is delivered 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. ommunication

. 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, cont Jude Medical. Suboptimal RF Communication. For devices with RF telemetry capability, 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 |

ist of potential causes to suboptimal radio communication:

Table 3. Possible causes and solutions for suboptimal RF communication Possible Causes The Merlin Antenna orientation/location is Suboptimal. Move or reorient the Merlin Antenna slightly. Make s that the front of the Merlin Antenna faces the implantable 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 interferin g objects/people. The Merlin Antenna Is too far away from 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. 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 ray signal is present. Continuous exposure may cau se a temporary sensor rate increase. In 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 conte nts 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. Do not subject the pulse generator to temperatures above 50C (122F) or below

(23F). Exposure to temperatures b elow OC 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. eparation 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 pro 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 te lemetry 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 n the screen during the session, the device is not RF compatible. Once you have established telemetry, select "Interrogate."

The unit's Measured Data will be displayed on the FastPath Summary screen and should indicate normal voltage and battery status, a nd the programmed 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. It damage Is suspected, return It to the manufa

"Use Before" Date. Do not implant the device after the "Use before" date printed on the label. 0) oy -Y aN nt -4m alae ae: (00,-}-4om If interrogation of the device in its sterile packaging indicates normal functioning, remove it from the package. The package's oute r tray can be opened in nonsterile Surroundings. However, when opening the inner tray, complete sterile technique must be observed. Implant Testing Compatible Pacing Leads. Devices with IS l connectors accept unipolar or bipolar IS 1 short terminal n leads. Devices with |S4 LLLL connectors accept IS4 LLLL quadripolar leads.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. Use only IS 1 PSA cable adaptor probes when testing the device. Other probes may damage the connector. Do not use IS 1 adaptor probes in the |S4 LLLL 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 bipol ar 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 Ps). After the leads have been nted 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 discri minate 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 untila marked change in morphology occurs, indicating capture loss on both sides. Implantation 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 OFT Ere 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. Programmer. These devices can be interrogated and programmed with the Merlin PCS equipped ith Model 3330 version 17.1.1 (or greater) software. For a list of programmable parameters and their programmable values, refer to the programmer's on Slontslol amnion Setting Lead Type. When you interrogate the device for the first time, the programmer will prompt you to set the Lead Type. In CRT Ps, the right 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 imola Lead Impedance Values. Ps, independent lead impedance values are displayed for the RV and Ventricular Pulse Amplitudes and Pulse Widths. Ps, the right and left ventricular pulse amplitudes and pulse widths are independently pr ogrammable. The pulse amplitude should be evaluated in each chamber accordingly. Typically, capture thresholds are higher in the left ventricle. up Capture Threshold Measurements. Ps, 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 Slontolclaiuaiey on AOO(R), VOO(R), and DOO(R) Modes arily intended for temporary diagnostic use. Long use may result in competitive pacing, inducing potentially dangerous arrhythmias. 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 pacing system 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 capt ure thresholds periodically. No ETA one eye e Oh Led E Atrial or ventricular tachycardia or fibrillation may occur during NIPS. Therefore, (1) closely monitor the patient, and (2) have emergency equipment for cardioversion/defibrillation read ily available while conducting NIPS. Output Settings. Programming high output settings or a high Base Rate may shorten the time to Runaway Protection. Hardware circuitry in the device prevents it from stimulating at rates higher than

) for PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM3120, PM3140, PM3222, PM3242 devices. For all other devices, the rate threshold is 210 Sensing Configuration. Sensing tests should be performed whenever changes are made to the se Patient Notifier. Before setting Patient Notifier On, test and ensure patient awareness of the Patient Notifier feature. Environmental and Medical Therapy Hazards St. Jude Medical devices are equipped with special shielding and filte rs 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 adver sely 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 equioment that produces hig electromagnetic field strength signals, such as diathermy machines and electrosurgical units. External Defibrillation. The electronic circuitry in the device provides protection from defibrillation discharges. Nevertheless, do not place defibrillator pad dles 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 sho uld carefully weigh the decisions to use MRI ith 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 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. lonizing 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 r 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. Befor e 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 on e 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 pro srammed 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 ele ctrocautery 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 Ablatio n. Radiofrequency (RF) ablation in patients with a device may cause any of the following: asynchronous pacing above or below the programmed rate; reversion to an asynchronous operation; device electrical reset; premature triggering of the elective replacem indicator, or device malfunction or damage. Minimize RF ablation risks by:

Programming a non rate responsive, asynchronous pacing mode prior to the RF ablation procedure Avoiding direct contact between the ablation catheter and the implanted lead or pu generator Positioning the groundoplate so that the current pathway does not pass near the pulse generator system, |.e., place the groundplate under the patient's buttocks or legs Having external defibrillation equipment available Having a programmer ava Patient Environment Voltage transmission lines and equipment, arc or resistance welders, induction furnaces, Similar equipment may generate substantial EMI fields that may interfere with device operation. Communication Equipment, icrowave transmitters

, linear power amplifiers, or high 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 Applianc 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 tients 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 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 Ps. It is very unlikely that these systems will intera ct with their device significantly. However, to minimize the possibility of interaction, advise patients to simply walk through these areas at a normal Home appliance microwave ovens do not interfere with device operation. pace and avoid lingering near or leaning on these systems. No Pacer Symbol. Caution patients implanted w ith this device to avoid areas marked with the NO PACER symbol. No Pacer Symbol to) Cellular Phones. A St. Jude Medical designed protective filter in the device prevents cellular phone generated electromagnetic signals from interfering with the operation of The device has also been tested for compatibility with handheld wireless transmitters in accordance ith the requirements of AAMI PC69. This testing covered the operating frequencies (450 GHz) and pulsed modulation techniques of all o f the digital cellular phone technologies in worldwide use today. For more information, you or your patient may wish to contact Technical Support Carrillo R, Williams DB

, lraad EA, Schor JS. Electromagnetic filters impeded adverse interference of pacemakers by digital cellular elephones. JACC 1996; 27(2A):15A Abstract 901 Explantation Do not reuse explanted devices and leads. Clean explanted equip ith +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 indwel ling 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 tamponad e or perforation 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 e lectrical 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 ral 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 Pulmonary edema Rise in threshold and exit block Valve damage Cardiac/coronary sinus dissection (CRT Ps only) Cardiac/coronary sinus perforation (CRT Ps only) Coronary sinus or cardiac vein thrombosis (CRT Ps only) Clinician Use Information sense Configuration is set to Bipolar, the Atrial Sensitivity setting of 0.2 mV or more sensitive settings may be more susceptible to EMI. The devices comply with the electromagnetic compatibility requirements of CENELEC standard EN45502

, Clause 27.5, at Atrial Sensitivity settings of 0.3 mV and less sensitive settings. When the Sense Configuration is set to Unipolar, the Atrial and Ventricular Sensitivity settings more sensitive settings than 2.0 mV may be more susceptible to EMI. The devices comply w ith the electromagnetic compatibility requirements of CENELEC standard EN45502 1, clause 27.5 at Atrial and Ventricular Sensitivity settings of 2.0 mV and less sensitive settings. (CENELEC standard EN45502 1, clause 27.5.1 requires that the implantable pulse generator be constructed so that commonly encountered electromagnetic signals are unlikely to be confused with sensed beats and change the therapeutic behavior of the implantable pulse generator.) As referenced in this section, the CENELEC standard EN45502 1:2003 is equivalent to ANSI/AAM

| PC69:2007. As required by EN 45502 1 Clause 27.4, the device interference mode of operation is characterized as follows:

The atrial noise mode is pacing off for EMI frequencies below approximately 30 Hz and fixed rate pacing for frequencies above approximately 30 The ventricular noise mode is fixed rate pac ing for EMI frequencies of 16.6 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 te lemetry 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 ef fects with the ability to quickly cancel or permanently program the setting. For more information, refer to the programmer's on Slontslol amnion Preset Programmed Settings Shipped Settings The device's parameter settings are preset when the device is manufact ured. For additional information, refer to the programmer's on screen help. 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 screen help. When Emergency VVI is selected, diagnostic data are cleared from memory without a Radiopaque Identification Each device has an X ray absorptive marker for noninvasive identification. The marker consists of the st. Jude Medical logo (SJM) and model code. Table 4. ray ID codes for the devices described in this manual Device Model ID Model Code PM1110, PM1160, PM1210, PM1240, PM1260, PM2110, PM2160, PM2210, PM2240, PM2260, PM3110, PM3120, 3140, PM3210, PM3222, PM3242 Implantation and Lead Connection Package Contents Devices are shipped in a sterile box containing:

One device Connector kit containing:

Torque wrench Lead Connection Devices with IS 1 connectors accept unipola melmelleel-iats 1 short terminal pin leads. Devices with |S4 LLLL connectors accept |S4 LLLL quadripolar 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 contact with the pin securing the lead within the connector while an annular spring makes contact with the proximal ring(s). Enter the lead types for each lead on the Patient Information screen. For additional information, refer to the programmer's on Slontolclaiuaiey on 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 a lead ECG or Intracardiac Electrogram (IEGM) To connect the device to the leads:

Remove blood and body fluids from the terminal pins of the implanted leads. Check the markings on the device case and verify proper atrial and ventricular connections. Exercise caution when turning the setscrew, which may be backed out of the connector if turned counterclockwise for more than two rotations. Ps: For proper sensing and pacing, It is important to ensure that left and right ventricular sig nals are correctly detected and that pacing pulses are delivered in the desired 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. Insert the lead pin firmly into the connector until it is immobile and visible in the viewport at the opposite end of the connector. Insert the torque wrench through the aperture on the header and into the setscrew on the side of the connector. Turn the torque wrenc h clockwise until it clicks. The wrench is torque limited and will not allow Sy AOle is hVommNlcamicolani alee Repeat the steps above for additional lead(s). Tug gently on the leads to ensure they are securely connected to the device. In order to minimize device migra tion, 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 onke\o) Ain aleil OF Ps, 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 OOOlaeliaciNs Ps, independen t 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 origin al should be returned to the manufacturer in the postage paid, addressed envelope provided. Copies of the registration form are orovided for the hospital and the physician. Device Longevity For estimated longevity calculations, see the programmer's on 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 before EOL. The nominal period is six months for PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM3120, PM3140, PM3222, PM3242. The nominal period for all other devices is three months. 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 on screen help. Oey la lata anne 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 Programming to high output settings or 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 eva

), the nominal life of the device is three or six months. When the device exhibits signs of ERI (described on the programmer's on screen help), it should be replaced expeditiously. Life (EOL) occurs when the battery voltage has fallen to approximately 2.50 V for all devices except PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM3120, PM3140, PM3222, PM324? devices. EOL for the listed devices is 2.47 For additional info rmation, refer to the programmer's on screen help. Technical Support 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. Physical Specifications Device Measurements e Measurements Dimensions Weight (g) Displaced volume PM1110 PM1160 PM1210 PM1260 The dimensions and weight are nominal values. Nominal values based on engineering model measurements. e Measurements Dimensions Weight (g) Displaced volume PM2110 2160 PM2210 PM2260 PM3110 PM3120 55 x 59x 6 56 x 59 x 6 PM3210 PM3222 55 x 59x 6 Device Materials Device Materials Case Coating Connector Material All devices Epoxy, Polysulfone Lead Compatibility ii leli-ws Lead compatibility Lead compatibility All devices For devices with RF telemetry capability. Accepts IS 1 short terminal pin leads. Battery Information Battery Information Power source Manufacturer; Model Voltage at BOL Voltage at ERI PM3120 PM3222 Greatbatch Medical;

Model 2662 QMR is a trademark of Greatbatch Medica F 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 MICS band: 402 405 MHz. Thee ffective radiated power is below the limits as specified in:

Europe: EN ETSI 301 839 USA: FCC 47 CFR Part 95; 95.601 95.673 Subpart E, 95.1201 95.1221 Subpart |

FCC ID: RIASJMRFB Harmonized with the FCC This transmitter is authorized by rule und er the Medical Device Radiocommunications Service (in 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 communic ate 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 soverning the Medical Device Radiocommunications Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee tha t it will not receive interference or that any particular transmission from this transmitter will be free from interference. The following is applicable to Canada only:

This device may not interfere with stations operating in the 400.150 406.000 meteorological aids, meteorological Satellite, and earth exploration Satellite services and must accept any interference received, including interference that may cause undesired operation. Temperature Effects Pacing parameters such as Pulse Rate, Pulse Width, Pulse Amplitude and Sensitivity meet the nominal tolerances defined in the programmers on screen help over the temperature range of 25C to 45C Exar Cardiac Rhythm Management Division St. Jude Medical Cardiac Rhythm Management Div 15900 Valley View Court Sylmar, CA 91342 USA

+1 818 362 6822 St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem ie aa nese Reelin 100079634 November 201?

Art 40009110 ST. JUDE MEDICAL MoE CONTROL, LESS RISK.