COGNIS 100-D Physicians Technical Manual

CONTENTS New or Enhanced Features... 1 Device Description... 2 Related Information ... 5 Indications and Usage ... 6 Contraindications... 6 Warnings ... 6 Precautions... 8 Potential Adverse Events ... 26 Mechanical Specifications ... 29 Lead Connections... 31 Items Included in Package ... 33 Symbols on Packaging ... 33 Characteristics as Shipped... 37 X-Ray Identifier... 39 Pulse Generator Longevity ... 40 Warranty Information ... 43 Product Reliability... 43 Patient Counseling Information ... 45 Patient Handbook... 46 Setscrew Locations ... 47

NEW OR ENHANCED FEATURES These pulse generator systems include additional features as compared to previous products. Ease of Use •

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ZOOMVIEW Programmer Software: the new user interface offers the following benefits: –

Clinical focus-features such as patient diagnostic trends and indications-based programming emphasize the patient’s clinical condition over device status and parameters.

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Consistency-ZOOMVIEW software will be available on future pulse generators, providing the same screens whether you are following a brady, tachy, or heart failure device.

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Simplicity-screen complexity is reduced through the use of progressive disclosure (displaying the information you use frequently and minimizing the information you only rarely access) and exception-based reporting.

Indications-Based Programming (IBP): the new ZOOMVIEW feature allows you to quickly set up programming parameters based on the patient’s clinical needs and indications. 1

Tachy Therapy •

Rhythm ID and Onset/Stability detection: the selection between detection enhancements provides you the opportunity and flexibility to adjust for individual patient conditions.

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QUICK CONVERT ATP: in an attempt to avoid an otherwise scheduled charge and painful shock for a pace-terminable fast ventricular tachycardia (VT), the pulse generator delivers one rapid burst of antitachycardia pacing (ATP) for an episode detected in the ventricular fibrillation (VF) zone.

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Programmable Shock Vectors: this capability allows you to electronically change the shocking vectors for added flexibility in treating high defibrillation thresholds (DFTs).

Sensing •

Sensing is designed to combine the strengths of both implantable cardioverter defibrillator (ICD) and pacemaker sensing capabilities to improve detection and therapy by reducing inappropriate mode switching, pacing inhibition, and shocks.

DEVICE DESCRIPTION This manual contains information about the COGNIS 100 family of cardiac resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in "Mechanical Specifications" on page 29). 2

Therapies This family of pulse generators has a small, thin, physiologic shape that minimizes pocket size and may minimize device migration. Pulse generators within this family provide a variety of therapies, including: •

Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death (SCD) such as VT and VF

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Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation

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Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy

Cardioversion/defibrillation therapies include: •

A range of low- and high-energy shocks using a biphasic waveform

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The choice of multiple shock vectors: –

Distal shock electrode to proximal shock electrode and pulse generator case (TRIAD electrode system)

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Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)

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Distal shock electrode to pulse generator case (RV Coil to Can) 3

Leads The pulse generator has independently programmable outputs and accepts the following leads: •

One IS-11 atrial lead

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One IS-1 coronary venous pace/sense lead

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One LV-1 coronary venous pace/sense lead

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One DF-1/IS-12 cardioversion/defibrillation lead

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One GDT-LLHH multipolar connector cardioversion/defibrillation lead

CAUTION: The GDT-LLHH multipolar connector cardioversion/defibrillation lead is intended for use only with pulse generators that are configured with the GDT-LLHH connector. The pulse generator and the leads constitute the implantable portion of the pulse generator system. PRM System These pulse generators can be used only with the ZOOM LATITUDE Programming System, which is the external portion of the pulse generator system and includes: 1. 2. 4

IS-1 refers to the international standard ISO 5841.3:2000. DF-1 refers to the international standard ISO 11318:2002.

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Model 3120 Programmer/Recorder/Monitor (PRM)

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Model 2868 ZOOMVIEW Software Application

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Model 6577 Accessory Telemetry Wand

You can use the PRM system to do the following: •

Interrogate the pulse generator

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Program the pulse generator to provide a variety of therapy options

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Access the pulse generator’s diagnostic features

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Perform noninvasive diagnostic testing

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Access therapy history data

RELATED INFORMATION Refer to the lead’s instruction manual for implant information, general warnings and precautions, indications, contraindications, and technical specifications. Read this material carefully for implant procedure instructions specific to the chosen lead configurations. The Physician’s Technical Manual is packaged with the pulse generator. It provides the technical information needed at implant. Refer to the PRM system Operator’s Manual for specific information about the PRM such as setup, maintenance, and handling. 5

INDICATIONS AND USAGE Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular (LV) dysfunction (EF ” 35%) and QRS duration • 120 ms. CONTRAINDICATIONS There are no contraindications for this device. WARNINGS General •

Labeling knowledge. Read this manual thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in patient injury or death.

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Avoid shock during handling. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks.

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Backup defibrillation protection. Always have sterile external and internal defibrillation protection available during implant. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.

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Resuscitation availability. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue.

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Protected environments. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator.

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Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MR device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

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Diathermy. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents.

Programming and Device Operations •

Atrial tracking modes. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF.

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Atrial-only modes. Do not use atrial-only modes in patients with heart failure because such modes do not provide CRT. 7

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Ventricular sensing. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition.

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Slow VT. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones.

Implant Related •

Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture.

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Patch leads. Do not use defibrillation patch leads with the pulse generator system, or injury to the patient may occur.

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Separate pulse generator. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery.

PRECAUTIONS Clinical Considerations •

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Pacemaker-mediated tachycardia (PMT). Retrograde conduction combined with a short PVARP might induce PMT.

Sterilization, Storage, and Handling •

For single use only; do not resterilize devices. Do not resterilize the device or the accessories packaged with it because the effectiveness of resterilization cannot be ensured.

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If package is damaged. The pulse generator blister trays and contents are sterilized with ethylene oxide gas before final packaging. When the pulse generator is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the device to Boston Scientific.

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Storage temperature and equilibration. Recommended storage temperatures are 0°C–50°C (32°F–122°F). Allow the device to reach a proper temperature before using telemetry communication capabilities, programming or implanting the device because temperature extremes may affect initial device function.

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Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets, and sources of EMI to avoid device damage.

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Use by date. Implant the device system before or on the USE BY date on the package label because this date reflects a validated shelf life. For example, if the date is January 1, do not implant on or after January 2.

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Implantation and Device Programming •

Lead system. Do not use any lead with this device without first verifying connector compatibility. Using incompatible leads can damage the connector and/or result in potential adverse consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy.

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Telemetry wand. Make sure the telemetry wand is connected to the programmer and that it is available throughout the session. Verify that the wand cord is within reach of the pulse generator.

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STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue to pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters will decrease device longevity.

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Biventricular pacing therapy. This device is intended to provide biventricular or left ventricular pacing therapy. Programming the device to provide RV-only pacing is not intended for the treatment of heart failure.

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Pacing and sensing margins. Consider lead maturation in your choice of pacing amplitude, pacing pulse width, and sensitivity settings. •

An acute pacing threshold greater than 1.5 V or a chronic pacing threshold greater than 3 V can result in loss of capture because thresholds may increase over time.

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An R-wave amplitude less than 5 mV or a P-wave amplitude less than 2 mV can result in undersensing because the sensed amplitude may decrease after implantation.

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Pacing lead impedance should be within the range of 200 Ÿ and 2000 Ÿ.

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Line-powered equipment. Exercise extreme caution if testing leads using line-powered equipment because leakage current exceeding 10 µA can induce ventricular fibrillation. Ensure that any line-powered equipment is within specifications.

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Proper programming of the lead configuration. If the Lead Configuration is programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.

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Proper programming of the shock vector. If the shock vector is programmed to RVcoil>>RAcoil and the lead does not have an RA coil, shocking will not occur.

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Replacement device. Implanting a replacement device in a subcutaneous pocket that previously housed a larger device may result in pocket air entrapment, migration, erosion, or insufficient grounding between the device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility of pocket air entrapment and insufficient grounding. Suturing the device in place reduces the possibility of migration and erosion.

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Defibrillation power surge. Defibrillation that causes a power surge exceeding 360 watt-seconds can damage the pulse generator system.

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Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmable options are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy.

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AV Delay. To ensure a high percentage of biventricular pacing, the programmed AV Delay setting must be less than the patient’s intrinsic PR interval.

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Adaptive-rate pacing. Adaptive-rate pacing should be used with care in patients who are unable to tolerate increased pacing rates.

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Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited by refractory periods. A long refractory period programmed in combination with a high MSR can result in asynchronous pacing during refractory periods since the combination can cause a very small sensing window or none at all. Use dynamic AV Delay or dynamic PVARP to optimize sensing windows. If you are entering a fixed AV delay, consider the sensing outcomes.

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Atrial Tachy Response (ATR). ATR should be programmed to On if the patient has a history of atrial tachyarrhythmias. The delivery of CRT is compromised because AV synchrony is disrupted if the ATR mode switch occurs.

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Threshold test. During the LV threshold test, RV backup pacing is unavailable.

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Left ventricular pacing only. The clinical effect of LV pacing alone for heart failure patients has not been studied.

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Do not bend the lead near the lead-header interface. Improper insertion can cause insulation damage near the terminal end that could result in lead failure.

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Shock waveform polarity. For IS-1/DF-1 leads, never change the shock waveform polarity by physically switching the lead anodes and cathodes in the pulse generator header-use the programmable Polarity feature. Device damage or nonconversion of the arrhythmia post-operatively may result if the polarity is switched physically.

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Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. If a lead is not used, be sure to properly insert a plug in the unused port.

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Electrode connections. Do not insert a lead into the pulse generator connector without first visually verifying that the setscrew is sufficiently retracted to allow insertion. Fully insert each lead into its lead port and then tighten the setscrew onto the electrodes.

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Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

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Atrial oversensing. Take care to ensure that artifacts from the ventricles are not present on the atrial channel, or atrial oversensing may result. If ventricular artifacts are present in the atrial channel, the atrial lead may need to be repositioned to minimize its interaction.

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Defibrillation lead impedance. Never implant the device with a lead system that has less than 15 Ÿ total shock lead impedance. Device damage may result. If a shocking lead impedance is less than 20 Ÿ, reposition the shocking electrodes to allow a greater distance between the shocking electrodes.

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ATR entry count. Exercise care when programming the Entry Count to low values in conjunction with a short ATR Duration. This combination allows mode switching with very few fast atrial beats. For example, if the Entry Count was programmed to 2 and the ATR Duration to 0, ATR mode switching could occur on 2 fast atrial intervals. In these instances, a short series of premature atrial events could cause the device to mode switch.

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ATR exit count. Exercise care when programming the Exit Count to low values. For example, if the Exit Count was programmed to 2, a few cycles of atrial undersensing could cause termination of mode switching.

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Left ventricular lead configuration. Proper programming of the LV coronary venous lead configuration is essential for proper LV lead function. Program the lead configuration in accordance with the number of electrodes on the LV lead; otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacing might occur.

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Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacing rate and may inhibit CRT at higher pacing rates.

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Shunting energy. Do not allow any object that is electrically conductive to come into contact with the lead or device during induction because it may shunt energy, resulting in less energy getting to the patient, and may damage the implanted system. 15

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Expected benefits. Determine whether the expected device benefits outweigh the possibility of early device replacement for patients whose tachyarrhythmias require frequent shocks.

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Device communication. Use only the designated PRM and software application to communicate with this pulse generator.

Environmental and Medical Therapy Hazards •

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Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. Examples of EMI sources are: •

Electrical power sources, arc welding equipment, and robotic jacks

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Electrical smelting furnaces

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Large RF transmitters such as radar

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Radio transmitters, including those used to control toys

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Electronic surveillance (antitheft) devices

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An alternator on a car that is running

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Radio and Telecommunications Terminal Equipment (RTTE). Boston Scientific declares that this device is in compliance with the essential requirements and other relevant provisions of the current RTTE directive. NOTE: As with other telecommunications equipment, verify national data privacy laws.

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Elevated Pressures. Elevated pressures due to hyperbaric chamber exposure of SCUBA diving may damage the pulse generator. The pulse generator has been tested to function normally at 1.5 Atmospheres Absolute (ATA) pressure or 15 ft (4.6 m) depth in sea water. For specific guidelines prior to hyperbaric chamber exposure, or if the patient is planning scuba diving activity, contact Technical Services at the number shown on the back cover of this manual.

Hospital and Medical Environments •

Mechanical ventilators. During mechanical ventilation, respiration rate trending may be misleading; therefore, the Respiratory Sensor should be programmed to Off.

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Internal defibrillation. Do not use internal defibrillation paddles or catheters unless the pulse generator is disconnected from the leads because the leads may shunt energy. This could result in injury to the patient and damage to the implanted system.

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External defibrillation. Use of external defibrillation can damage the pulse generator.

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Transcutaneous electrical nerve stimulation (TENS). TENS may interfere with pulse generator function. If necessary, the following measures may reduce interference: 1.

Place the TENS electrodes as close to each other as possible and as far from the pulse generator and lead system as possible.

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Monitor cardiac activity during TENS use.

For additional information, contact Technical Services at the number shown on the back cover of this manual.

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