Abbott | Life-Changing Health Care Technologies
eLabeling | Abbott
Instructions for Abbott models including: HF CRT-D Cardiac Resynchronization Therapy Devices, HF CRT-D, Cardiac Resynchronization Therapy Devices, Therapy Devices, Devices
19 mag 2024 — MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when ... Refer to the User's Manual for detailed intended use, indications ...
File Info : application/pdf, 6 Pages, 202.47KB
DocumentDocumentCARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) GallantTM HF CRT-D CDHFA500T Compatible with myMerlinPulseTM app Product Highlights · Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption · MultiPointTM pacing delivers multiple LV pacing pulses per cardiac cycle in both LV only and BiV pacing modes · SyncAVTM Plus CRT technology offers dynamic AV timing with adaptive programming to ensure BiV pacing with or without MultiPoint pacing · Improved shape with reduced volume and thickness · 40J delivered energy safety shock option for enhanced safety margin · DeFT ResponseTM technology offers noninvasive programming options to optimize rescue therapy to each patient's unique physiology and changing conditions · VF Therapy Assurance decreases the time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable · Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock · ShockGuardTM technology with DecisionTxTM programming is designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant SecureSenseTM RV lead noise discrimination algorithm detects sustained lead noise and short bursts of oversensing that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks Far Field MDTM morphology discrimination and chamber onset discrimination enhances SVT and VT discrimination for reduced inappropriate therapies · SenseAbilityTM sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity · The Gallant HF CRT-D and QuartetTM quadripolar LV lead feature four pacing electrodes and 13 pacing vectors to provide more options and greater control to address implant complications such as diaphragmatic stimulation and high pacing thresholds · Easily test and program with Auto VectSelect QuartetTM multivector testing, offering an efficient workflow for complete results and programming · DynamicTxTM over-current detection algorithm automatically changes shock configurations to ensure delivery of highvoltage therapy when high current is detected · MRI-Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5T or 3T (Tesla) field strength MRI Scanner* · The CorVueTM thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient's heart failure condition · Cold can programmability provides an additional RV-SVC shock configuration to decouple the can from the shocking vector parameters in cases of lead problems · Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone · Physiologic rate responsive AV Delay and PVARP · QuickOptTM timing cycle optimization provides quick and effective optimization at the push of a button · Dual patient notification: audio notification through the device and visual notification via myMerlinPulse app GallantTM HF CDHFA500T CRT-D DEVICE Ordering Information Contents: Cardiac Pulse Generator MODEL NUMBER DIMENSIONS (L × W × H) (MM) WEIGHT (G) VOLUME (CC) CONNECTOR DEFIBRILLATION CONNECTOR SENSE/PACE CDHFA500T 79 × 51 × 12 *See MRI Scan Parameters in MRI-Ready Systems Manual. 77 37 DF-1 IS-1 CONNECTOR PACE - LEFT VENTRICLE IS-4 Product Specifications PARAMETER SPECIFICATIONS Model Telemetry Delivered/Stored Energy Volume Weight Size Defibrillation Lead Connection Atrial Sense/Pace Lead Connection Ventricular Sense/Pace Lead Connection Left Ventricular Pace Lead Connection High Voltage Can Parameter Biventricular Pacing VectSelect QuartetTM Programmable LV Pulse Configuration MultiPointTM Pacing Delay MultiPoint Pacing V. Triggering QuickOptTM Timing Cycle Optimization V-V Timing Interventricular Pace Delay Ventricular Sensing Ventricular Pacing Chamber SyncAVTM Plus CRT Technology Delta MPP PVAB AF Management AF SuppressionTM Pacing No. of Overdrive Pacing Cycles Maximum AF Suppression Rate CDHFA500T Bluetooth® LE Communication 40/45 J 37 cc 77 g 79 × 51 × 12 mm DF-1 IS-1 in-line bipolar IS-1 in-line bipolar IS4-LLLL Electrically active titanium can Settings Distal Tip 1 - Mid 2; Distal Tip 1 - Proximal 4; Distal Tip 1 - Mid 3; Distal Tip 1 - RV Coil; Mid 2 - Mid 3; Mid 2 Proximal 4; Mid 2 - RV Coil; Mid 3 - Mid 2; Mid 3 - Proximal 4; Mid 3 - RV Coil; Proximal 4 - Mid 2; Proximal 4 - Mid 3: Proximal 4 - RV Coil LV1, LV2 Delay 1: 5; 10; ... 80 ms Delay 2: 5; 10; ... 50 ms On; Off Sensed/Paced AV delay, Interventricular pace delay Simultaneous; RV First; LV First RV First 1080/LV First 1580 ms RV only (not programmable) RV only; LV only; Biventricular If Type = Percentage: -10; - 15;...-70% If Type = Fixed: -10; -20;...-120 ms; Off 125-260 ms On; Off 15-40 80-150 bpm GallantTM HF CDHFA500T CRT-D DEVICE Product Specifications Sensing/Detection SenseAbilityTM Sensing Algorithm Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory Detection Zones SVT Discriminators Monitor Mode Discrimination Modes SVT Upper Limit SVT Discrimination Timeout Reconfirmation SecureSenseTM RV Lead Noise Discrimination Algorithm VF Therapy Assurance Antitachycardia Pacing Therapy ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min. Burst Cycle Length Readaptive Number of Bursts/Stimuli Add Stimuli per Burst ATP Pulse Amplitude ATP Pulse Width High-Voltage Therapy DynamicTxTM Over-current Detection Algorithm DeFT ResponseTM Technology High-Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Permanent Modes Temporary Modes Activity Sensor Programmable Rate and Delay Parameters Pulse Amplitude Pulse Width LVCapTM Confirm Feature, LVCapTM 2 Confirm Feature RVCapTM Confirm Feature Automatic sensitivity control adjustment for atrial and ventricular events On; Off Post-Sensed: 50; 62.5; 75; 100% Post-Paced, Atrial: 0.2-3.0 mV Post-Paced, Ventricular: Auto, 0.2-3.0 mV Post-Sensed: 0-220 ms Post-Paced, Atrial: 0-220 ms Post-Paced, Ventricular: Auto, 0-220 ms 125; 157 ms 3 zone programming -- 1 zone; 2 zones; or 3 zones (VT-1; VT-2; VF) AV Rate Branch; Arrhythmia Onset (Chamber Onset or Sudden Onset); Interval Stability; AV Association Morphology; Discrimination (Far Field MDTM Morphology Discrimination or Original MD) with Automatic Template Update Detection, discrimination, and diagnostics, no therapy delivery (VT or VT-1 zone) On; Passive; Off 150-240 bpm 20s-60 min; Off Continuous sensing during charging On; On with Timeout; Passive; Off On; Off Ramp; Burst; Scan; 1 or 2 schemes per VT zone ATP While Charging; ATP Prior to Charging; Off 150300 bpm Adaptive (50%-100%); Fixed (200-550 ms) 150-400 in increments of 5 ms On; Off 1-15 with 220 Stimuli On; Off 7.5 V independent from bradycardia and post-therapy pacing 1.0 or 1.5 ms independently programmable from bradycardia and post-therapy pacing On: Off Programmable pulse width for P1/P2 and tilt Fixed Pulse Width; Fixed Tilt Biphasic; Monophasic Cathode (-); Anode (+) RV to Can; RV to SVC/Can; RV to SVC DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); Off DDD; DDT; DDI; VVT; VVI; AAI; AAT; DOO; VOO; AOO; Off On; Passive; Off Base Rate (bpm); Rest Rate (bpm); Maximum Tracking Rate (bpm); Max Trigger Rate (bpm); Maximum Sensor Rate (bpm); Paced AV Delay (ms); Sensed AV Delay (ms); Rate Responsive AV Delay; Hysteresis Rate (bpm); Rate Hysteresis with Search 0.25-7.5 V 0.05, 0.1-1.5 ms Setup; On; Monitor; Off Setup; On; Monitor; Off GallantTM HF CDHFA500T CRT-D DEVICE Product Specifications Bradycardia Pacing ACapTM Confirm Feature On; Monitor; Off Auto Mode Switch (AMS) DDI(R); DDT(R); VVI(R); VVT(R); Off Atrial Tachycardia Detection Rate 110-300 bpm AMS Base Rate 40; 45; ... 135 bpm PMT Detection/Termination Atrial Pace; Passive; Off Rate Responsive PVARP Low; Medium; High; Off Rate Responsive V Pace Refractory On; Off PAC Response On; Off PAC Response interval 200-400 ms Shortest AV Delay 25-120 ms Post-Therapy Pacing (Independently programmable from Bradycardia and ATP) Post-Shock Pacing Mode AAI; VVI; DDI; or DDD; Off Post-Shock Base Rate 30-100 bpm Post-Shock Pacing Duration 0.5; 1; 2.5; 5; 7.5; or 10 min; Off Device Testing/Induction Methods DC FibberTM Induction Method Pulse Duration 0.5-5.0 sec Burst Fibber Cycle Length 20-100 ms Noninvasive Programmed Stimulation (NIPS) 2-25 stimuli with up to 3 extra stimuli Patient Notifiers Programmable Notifiers (On; Off) BatteryAssuranceTM alert; Possible HV circuit damage; HV charge timeout; Long charge time for Capacitor Maintenance; Device at ERI; Atrial pacing lead impedance out of range. Ventricular pacing lead impedance out of range; High-voltage lead impedance out of range; AT/AF Episode duration; AT/AF Burden; High ventricular rate during AT/AF; SecureSenseTM lead noise detection; Non-sustained ventricular oversensing; Ventricular pacing percentage greater than limit. Device Parameter Reset On Entry into Backup VVI Mode On Auditory Duration 2; 4; 6; 8; 10; 12; 14; 16 sec Number of Audio alerts per Notification 2 Number of Notifications 116 Time Between Notifications 10; 22 hours Electrograms and Diagnostics Stored Electrograms 30 minutes (2 user programmable + discrimination channel), up to 1 minute programmable pre-trigger data per VT/VF electrograms; additional triggers include lead noise detection, non-sustained ventricular oversensing, morphology template updates, atrial episode, PMT termination, PAC response, magnet reversion, noise reversion Therapy Summary Diagram of therapies delivered Episodes Summary Directory listing of up to 60 episodes with access to more details including stored electrograms Lifetime Diagnostics History of bradycardia events and device-initiated charging AT/AF Burden Trend Trend data and counts Ventricular HV Lead Impedance Multi-Vector Trend Data Histograms and Trends Event Histogram; AV Interval Histogram; Mode Switch or AT/AF Duration Histogram; Peak Filtered Atrial Rate during Atrial Arrhythmia Histogram; Atrial Heart Rate Histogram; Ventricular Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending; V Rates during AMS; DirectTrendTM reports up to 1 year PMT Data Information regarding PMT detections Real-Time Measurements (RTM) Pacing lead impedances; High-voltage lead impedances; Signal amplitudes CorVue Thoracic Impedance On; Off CorVue Thoracic Impedance Threshold 8-18 days GallantTM HF CDHFA500T CRT-D DEVICE Product Specifications MRI Settings Tachy Therapy MRI Mode MRI Base Rate MRI Paced AV Delay MRI RA and RV Pulse Amplitude MRI RA and RV Pulse Width MRI RA and RV Pulse Configuration MRI LV Pulse Configuration MRI LV Pulse Amplitude MRI LV Pulse Width MRI V Pacing Chamber MRI Timeout Disabled DOO; VOO; AOO; Pacing Off 30-100 bpm 25-110 ms 5.0 or 7.5 V 1.0 ms Bipolar D1-M2, D1-M3, D1-P4, M2-M3, M2-P4, M3-M2, M3-P4, P4-M2, P4-M3 0.25-7.5 V 0.05-1.5 ms RV Only, LV+RV (Simultaneous) 3; 6; 9; 12; 24 hours; Off MRI SCAN PARAMETERS Lead Model DurataTM Defibrillation Lead 7120 (lead lengths: 60, 65 cm) 7122 (lead lengths: 60, 65 cm) OptisureTM Lead LDA220 (lead lengths: 60, 65 cm) LDA210 (lead lengths: 60, 65 cm) QuartetTM LV Lead 1456Q (lead length: 86 cm) 1457Q (lead length: 86 cm) 1458Q (lead length: 86 cm) 1458QL (lead length: 86 cm) TendrilTM STS Pacing Lead 2088TC (lead lengths: 46, 52 cm) Tendril MRITM Lead LPA1200M (lead lengths: 46, 52 cm) UltiPace Pacemaker Lead LPA1231 (Lead lengths46, 52 cm) Magnet (Tesla) 1.5 T / 3 T 1.5 T / 3 T 1.5 T / 3 T 1.5 T / 3 T 1.5 T 1.5 T / 3 T RF Transmit Conditions Scan Region Normal Operating Mode Full-body LV first with 10 ms interventricular delay. § For additional information about specific MR Conditional CRT-Ds and leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to the Abbott MRI-Ready Systems Manual at medical.abbott/manuals. GallantTM HF CDHFA500T CRT-D DEVICE Rx Only Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Intended Use: The Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles. The myMerlinPulseTM mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient's implanted heart device to the patient's healthcare provider. Indications: The CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony. In addition, dual chamber CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias. MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction. The myMerlinPulseTM mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices. Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. The myMerlinPulseTM mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices. Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User's Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events. No potential adverse events have been identified with use of the myMerlinPulseTM mobile application. Abbott 15900 Valley View Court, Sylmar, CA 91342 Tel: +1 818 362 6822 Abbott.com TM Indicates a trademark of the Abbott group of companies. Indicates a third party trademark, which is property of its respective owner. © 2024 Abbott. All Rights Reserved. MAT-2400585 v1.0 | Item approved for U.S. only.