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Owner's Manual for Abbott models including: CDDRA500T Gallant Dual Chamber ICD, CDDRA500T, Gallant Dual Chamber ICD, Dual Chamber ICD, Chamber ICD
2 apr 2025 — Threshold Start. Post-Sensed: 50; 62.5; 75; 100%. Post-Paced, Atrial: 0.2-3.0 ... 0.5; 1; 2.5; 5; 7.5; or 10 min; Off. Device Testing/Induction Methods. DC ...
‡ Indicates a third party trademark, which is property of its respective owner. ... please refer to the Abbott MRI-Ready Systems Manual at manuals.eifu.abbott.com ...
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DocumentDocumentIMPLANTABLE CARDIOVERTER DEFFIBRILLATOR (ICD) DEVICE GallantTM Dual Chamber ICD CDDRA500T Compatible with myMerlinPulseTM app Product Highlights · Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption · 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 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 extends the programming options for terminating tachyarrhythmias without a high-voltage shock · ShockGuardTM technology with DecisionTxTM programming 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 records 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 enhance 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 · 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* · Cold can programmability provides an additional RV-SVC shock configuration to decouple the can from the shocking vector parameters · The CorVueTM thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient's heart failure condition · Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone · Physiologic rate responsive AV Delay and PVARP · Dual patient notification: audio notification through the device and visual notification via myMerlinPulse app Ordering Information Contents: Cardiac Pulse Generator MODEL NUMBER CDDRA500T DIMENSIONS (L × W × H) (MM) 73 × 51 × 12 *See MRI Scan Parameters in MRI-Ready Systems Manual. WEIGHT (G) VOLUME (CC) 76 35 CONNECTOR CONNECTOR DEFIBRILLATION SENSE/PACE DF-1 IS-1 GallantTM Dual Chamber ICD CDDRA500T ICD DEVICE 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 High-Voltage Can Parameter AF Management AF SuppressionTM Pacing No. of Overdrive Pacing Cycles Maximum AF Suppression Rate Sensing/Detection SenseAbilityTM Sensing Algorithm CDDRA500T Bluetooth® LE Communication 40/45 J 35 cc 76 g 73 × 51 × 12 mm DF-1 IS-1 in-line bipolar IS-1 in-line bipolar Electrically active titanium can Settings On; Off 15-40 80-150 bpm Automatic Sensitivity Control adjustment for atrial and ventricular events 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 Number of Stimuli Add Stimuli per Burst ATP Pulse Amplitude ATP Pulse Width 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; 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 150-300 bpm Adaptive (50%-100%); Fixed (200-550 ms) 150-400 ms On; Off 1-15 2-20 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 GallantTM Dual Chamber ICD CDDRA500T ICD DEVICE Product Specifications PARAMETER SPECIFICATIONS High-Voltage Therapy DynamicTxTM Over-current Detection Algorithm On; Off DeFT ResponseTM Technology Programmable pulse width for P1/P2 and tilt High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Monophasic RV Polarity Cathode (-); Anode (+) Electrode Configuration RV to Can; RV to SVC/Can; RV to SVC Bradycardia Pacing Permanent Modes Off; DDD(R); DDI(R); VVI(R); AAI(R) Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO Activity Sensor On; Passive; Off Programmable Rate and Delay Parameters Base Rate (bpm); Rest Rate (bpm); Maximum Tracking 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 Pulse Amplitude 0.25-7.5 V Pulse Width 0.05 ms; 0.1-1.5 ms Ventricular AutoCaptureTM Pacing System On; Off ACapTM Confirm Feature On; Monitor; Off QuickOptTM Timing Cycle Optimization Sensed/Paced AV delay Auto Mode Switch (AMS) DDI(R); VVI(R); Off Atrial Tachycardia Detection Rate 110-300 bpm AMS Base Rate 40; 45; ... 135 bpm Rate Responsive PVARP Low; Medium; High; Off Rate Responsive V Pace Refractory On; Off PAC Response On; Off PAC Response Interval 200-400 ms PMT Detection/Termination Atrial Pace; Passive; Off Ventricular Intrinsic Preference (VIPTM) On (50-200 ms); Off Post-Therapy Pacing (Independently programmable from Bradycardia and ATP) Post-Shock Pacing Mode AAI; VVI; DDI; 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 GallantTM Dual Chamber ICD CDDRA500T ICD DEVICE Product Specifications PARAMETER SPECIFICATIONS Patient Notifiers Programmable Notifiers (On; Off) Device Parameter Reset Entry into Backup VVI Mode Auditory Duration Number of Audio alerts per Notification Number of Notifications Time Between Notifications Electrograms and Diagnostics Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT/AF Burden Trend Ventricular HV Lead Impedance Histograms and Trends PMT Data Real-Time Measurements (RTM) CorVueTM Thoracic Impedance CorVue Thoracic Impedance Threshold MRI Settings Tachy Therapy MRI Mode MRI Base Rate MRI Paced AV Delay MRI Pulse Amplitude MRI Pulse Width MRI Pulse Configuration MRI Timeout 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 On On 2; 4; 6; 8; 10; 12; 14; 16 sec 2 116 10; 22 hours 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 Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device-initiated charging Trend data and counts Multi-Vector Trend Data 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 Information regarding PMT detections Pacing lead impedances; High-voltage lead impedances; Signal amplitudes On; Off 818 days Disabled DOO; VOO; AOO; Pacing Off 30 - 100 bpm 25-120 ms 5.0 or 7.5 V 1.0 ms Bipolar Off; 3; 6; 9; 12; 24 hours GallantTM Dual Chamber ICD CDDRA500T ICD DEVICE MRI SCAN PARAMETERS Lead Model DurataTM Defibrillation Lead 7120 (lead lengths: 65 cm) 7122 (lead lengths: 60, 65 cm) OptisureTM Lead LDA210 (lead lengths: 65 cm) TendrilTM STS Pacing Lead 2088TC (lead lengths: 46, 52 cm) UltiPace Pacemaker Lead LPA1231 (Lead lengths 46, 52 cm) Magnet (Tesla) 1.5 T / 3 T 1.5 T / 3 T 1.5 T / 3 T 1.5 T / 3 T RF Transmit Conditions Scan Region Normal Operating Mode Full-body For additional information about specific MR Conditional ICDs 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 manuals.eifu.abbott.com. 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. 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-2407063 v1.0 | Item approved for OUS use.