Implant manual Implantable cardioverter defibrillator DR model 154
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TABLE OF CONTENTS 1. General description................................................................................................................ 5 2. Indications............................................................................................................................... 6 3. Contraindications.................................................................................................................... 7 4. 4.1. 4.2. 4.3. 4.4. 4.5. Warnings and precautions...............
15.2. 15.3. 15.4. 15.5. Magnet mode.......................................................................................................................... 38 Response in the presence of interference..............................................................................38 Detection characteristics in the presence of electromagnetic fields........................................39 Protection against short-circuits......................................................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION INTENSIA DR 154 is an implantable dual-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. INTENSIA DR 154 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home.
2. INDICATIONS 2. INDICATIONS INTENSIA DR 154 is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: ─ Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, ─ Recurrent, poorly tolerated sustained ventricular tachycardia (VT). NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of INTENSIA DR 154 is contraindicated in patients: ─ whose ventricular tachyarrhythmias may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes, ─ who present incessant tachyarrhythmia, ─ who have an internal pacemaker, ─ whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
4. WARNINGS AND PRECAUTIONS 4. WARNINGS AND PRECAUTIONS The patient should be warned of the potential risks of defibrillator malfunction if he is exposed to external magnetic, electrical, or electromagnetic signals. These potential interference sources may cause conversion to inhibited mode (because of noise detection), erratic delivery of VT or VF therapies, nominal programming, or much more rarely, irreversible damage to the device’s circuits.
4. WARNINGS AND PRECAUTIONS CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensing circuits can detect this as P-waves or R-waves, and such oversensing could result in inappropriate pacing, inhibition, or therapy. Normal activities after implant do not result in such oversensing. 4.1.
4. WARNINGS AND PRECAUTIONS immediately detectable. If irradiation of tissues close to the implantation site is necessary, it is recommended that the cardiac defibrillator be moved. As a safety measure, an external defibrillator should be immediately available. Lithotripsy: Lithotripsy may permanently damage the device if it is at the focal point of the lithotripsy beam. If lithotripsy must be used, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) away from the focal point of the lithotripsy beam.
4. WARNINGS AND PRECAUTIONS In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed. If the interaction between the ICD and the pacemaker cannot be resolved through repositioning of the leads or reprogramming of either the pacemaker or the ICD, the pacemaker should not be implanted (or should be explanted if previously implanted).
4. WARNINGS AND PRECAUTIONS If a thoracotomy is required to place epicardial patches, it should be done during a separate procedure to reduce the risk of morbidity and mortality. Do not place the patch lead over nerve tissue as this may cause nerve damage. Place the patch lead with the conducting coil side facing the heart to ensure delivery of energy to the heart. Place the sutures well outside the coil of the patch lead or in the area between the coils to avoid possible coil fracture.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. INTENSIA DR 154 is similar in design and function to the Defender devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker. The data provided are applicable to INTENSIA DR 154. 5.1.
5. ADVERSE EVENTS All complications, 14 of 38 Defender IV DR 612 patients in Europe Event # of Patients* % of Patients # of Events Events/100 DeviceYears** Change in ventricular sensing threshold 1 2.6 1° 5.2 Device reset*** 1 2.6 1° 5.2 Inappropriate therapy for EMI 1 2.6 1° 5.2 Pneumothorax 1 2.6 1° 5.2 Pocket hematoma 2 5.3 2° 10.5 Pocket infection/hematoma 1 2.6 1° 5.2 Pocket infection from previous pacemaker 1 2.6 1° 5.2 Prolonged implant procedure 1 2.
5. ADVERSE EVENTS Non-serious pacemaker related events outside the use of SafeR (AAI <> DDD) 0 0 0 0 Serious events due to the use of SafeR (AAI <> DDD) 0 0 0 0 Non-serious events related due to the use SafeR (AAI <> DDD) 13 28.9 15 3.2 Serious non-pacemaker related events 6 13.3 9 1.9 Non-serious non-pacemaker related events (a) 8 17.8 8 1.7 4.
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. INTENSIA DR 154 is similar in design and function to the Defender devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker. The data provided are applicable to INTENSIA DR 154. 6.1.
6. CLINICAL STUDIES Pe Observed experimental proportion 0.95 Ps Null hypothesis success rate 0.76 ES Estimated standard error of Pe 0.04 z´ Test statistic (1) 4.75 p Associated p-value < 0,0001 (1) Statistical test: z´ = (Pe-Ps)/SE where SE = sqrt(Pe(1-Pe)/N) 6.1.2 . Rate response European patients only: GROUP Number of patients included Mean slope %SRR on %MR STD of slopes %SRR on %MR SE of mean Lower 95% slope %SRR CI on %MR Upper 95% CI Europe 20 0.77 0.17 0.04 0.69 0.
6. CLINICAL STUDIES Event Europe (N=38) Number of events* Number of patients Percent of patients Intent to treat but did not 0 0 0.0 Non-device related death 1 1 2.6 Explant 1 1 2.6 Complication 3 2 5.3 Observation 18 14 36.8 Serious non-related other than death 12 7 18.4 Event All (N=60) Number of events* Number of patients Percent of patients Intent to treat but did not 0 0 0.0 Non-device related death 1 1 1.7 Explant 1 1 1.7 Complication 3 2 3.
6. CLINICAL STUDIES criteria for switching from AAI to DDD (or vice versa) did not change. The device’s method for evaluating the presence of AV conduction did not change. Methods: All patients were implanted with a Symphony Model 2550 dual-chamber rate-responsive pacemaker with SafeR (AAI <> DDD) mode. A variety of marketed atrial and ventricular pacing leads were used. The pacemaker was programmed and interrogated via bidirectional telemetry using a Sorin dedicated programmer and a CPR3 programming head.
6. CLINICAL STUDIES The actual reduction of ventricular pacing that SafeR (AAI <> DDD) provides in an individual will depend on the amount of time that the patient spends in AV block. SafeR (AAI <> DDD) cannot and should not provide any decrease in ventricular pacing while the patient is in AV block. (1) Pioger G, Jauvert G, Nitzsché R, Pozzan J, Laure H, Zigelman M, Leny G, Vandrell M, Ritter P, and Cazeau S. Incidence and predictive factors of atrial fibrillation in paced patients.
6. CLINICAL STUDIES Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on 2nd degree AV block, inappropriate classification of a PAC, disagreement between markers and recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave in a refractory period, and disagreement in the statistics for switches to DDD. No patient symptoms were associated with these events.
7. PATIENT SELECTION AND TREATMENT 7. PATIENT SELECTION AND TREATMENT 7.1. INDIVIDUALIZATION OF TREATMENT Exercise stress testing: If the patient’s condition permits, use exercise stress testing to: ─ Determine the maximum rate of the patient’s normal rhythm, ─ Identify any supraventricular tachyarrhythmias, ─ Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.
7. PATIENT SELECTION AND TREATMENT 7.2. SPECIFIC PATIENT POPULATIONS Pregnancy: If there is a need to image the device, care should be taken to minimize radiation exposure to the foetus and the mother. Nursing Mothers: Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk. Pediatric Patients: This device has not been studied in patients younger than 18 years of age.
8. PATIENT COUNSELLING INFORMATION 8. PATIENT COUNSELLING INFORMATION The physician should consider the following points in counselling the patient about this device: ─ Persons administering CPR may experience tingling on the patient’s body surface when the patient’s ICD system delivers a shock. ─ Advise patients to carry Sorin ID cards and/or ID bracelets documenting their ICD system.
9. CONFORMANCE TO STANDARDS 9. CONFORMANCE TO STANDARDS This device was developed in conformance with all or parts of the following standards: ─ EN 45502-1: 1998 – Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer. ─ EN 45502-2-1: 2003 – Active implantable medical devices. Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers).
9. CONFORMANCE TO STANDARDS Sorin declares that this device is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutual recognition of their conformity (R&TTE). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.105(b) The FCC product ID is YSGDR154. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
9. CONFORMANCE TO STANDARDS This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Cet appareil numérique de la classe B respecte toutes les exigences du règlement sur le matériel brouilleur du Canada.
10. PHYSICIAN GUIDELINES 10. PHYSICIAN GUIDELINES 10.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator implant procedure and familiar with follow-up evaluation and management of patients with an implantable defibrillator (or referral to such a physician). 10.2. DIRECTIONS FOR USE ICD operating characteristics should be verified at the time of implantation and recorded in the patient file.
11. PATIENT INFORMATION 11. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in the outer storage package. Additional copies can be obtained by contacting your Sorin representative or on the Sorin's web site: http://www.sorin.com. This information should be given to each patient with their first ICD and offered to the patient on each return visit or as deemed appropriate.
12. HOW SUPPLIED 12. HOW SUPPLIED 12.1. STERILITY The INTENSIA defibrillators are supplied one per package in a sterile package. 12.2. WARRANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators. Refer to the section "Warranty" for additional information. Please see the following labelling sections for information concerning the performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The INTENSIA DR system includes the model 154 ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The INTENSIA DR 154 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm².
13. DEVICE DESCRIPTION ─ Rescue shock ─ Follow-up tests: ─ Pacing lead impedance, ─ Coil impedance, ─ Capacitor charge time, ─ Pacing threshold tests. ─ Data storage: ─ Therapy History Report, ─ Statistics (pace/sense, therapy, shocks, and battery voltage), ─ Up to 14 complete Holter records with event logs, marker channel notation, and electrogram records. The connector head has two ports: ─ atrial bipolar pace/sense, ─ one ventricular bipolar pace/sense and RV & SVC defibrillation coils.
14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE 14.4. BEFORE OPENING THE PACKAGE Before opening the package, check the "Use Before" date printed on the labels on the box and on the sterile package. Defibrillators that have not been implanted before that date should be returned to Sorin. Interrogate the device: ─ if a warning is displayed, do not implant the device and contact your Sorin representative.
14. IMPLANT PROCEDURE NOTE1: Please note that DF-1 standard compliant lead is not compatible with DF-4 connector. In the opposite, DF-4 standard compliant lead is not compatible with DF-1 connector. In case of defibrillator replacement and use of a DF-1 lead or any other lead type that require an adaptor for this device, please contact your Sorin representative for any information on lead / connector compatibility question.
14. IMPLANT PROCEDURE Pacing impedance measurements: Ventricular and atrial pacing impedances should range from 200 to 3000 ohms (refer to the lead characteristics, especially if high impedance leads are used). 14.10. LEAD CONNECTION Implant the ventricular lead, then the atrial lead. Each lead must be connected to the corresponding connector port. The position of each connector is indicated on the casing. CAUTION: Tighten only the distal inserts. To connect each lead, proceed as follows: 1.
14. IMPLANT PROCEDURE WARNING: Ensure that the screwdriver's tip is fully inserted in the setscrew; otherwise the screwdriver can damage the setscrew and prevent connection with or disconnection from the lead. To ensure full insertion, push the screwdriver's hex tip smoothly into the setscrew until it reaches the bottom of the hex chamber in the screw, which could be felt as a solid metallic contact. Do not implant the defibrillator if there is no feeling of solid metallic contact.
15. SPECIAL MODES 15. SPECIAL MODES 15.1. SAFETY MODE (NOMINAL VALUES) Nominal values may be rapidly restored by pressing the following button on the programming head or programmer keyboard: or via the Emergency button on the SMARTVIEW screen. In safety mode, the defibrillator operates with the parameters underlined in the table of programmable parameters. 15.2.
15. SPECIAL MODES 15.4. DETECTION CHARACTERISTICS IN THE PRESENCE OF ELECTROMAGNETIC FIELDS Per Clause 27.4 of Standard EN 45502-2-2, detection in the presence of electromagnetic fields is characterized as follows: ─ Differential mode: ─ Common mode rejection ratio: 16.6 Hz 50 Hz 60 Hz Atrial channel ≥ 75 dB 64 dB 62 dB Ventricular channel ≥ 69 dB ≥ 57 dB ≥ 56 dB Modulated interference: For atrial sensitivity setting of 0.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on atrial and ventricular leads every 6 hours. The daily mean impedance is stored for each chamber. Automatic coil impedance measurement: A coil impedance measurement is automatically performed on RV and SVC coils once a week. The result is stored in the device memory. 16.2.
16. MAIN FUNCTIONS Post-shock mode: After any automatic shock therapy, the post-shock mode makes it possible to apply a pacing mode other than the standard antibradycardia pacing mode and/or with different pacing parameters. SafeR (AAI <> DDD) mode: Is intended to minimize deleterious ventricular pacing. The defibrillator functions in AAI mode, and temporarily switches to DDD mode upon the occurrence of AVB III, AVB II, AVB I and ventricular pause.
16. MAIN FUNCTIONS Alerts / Warnings: The device routinely performs security self-checks and technical measurements to ensure system integrity. When system integrity is found to be at risk outside a follow-up, alerts are stored in the device memory. When system integrity is found to be at risk during a follow-up, the information is managed as a warning (pop-up message) to notify immediately the user.
16. MAIN FUNCTIONS ─ battery status ─ lead status (brady leads and defibrillation coils) ─ pacing counters and mean heart rate (brady) ─ atrial and ventricular arrhythmia counters and episodes ─ ventricular therapy counters Data are presented in the form of 2 reports to the physician: the first one contains a summary of major counters, histograms, warnings and diagnosis.
17. PATIENT FOLLOW-UP 17. PATIENT FOLLOW-UP 17.1. FOLLOW-UP RECOMMENDATIONS Before the patient is discharged and at each subsequent follow-up visit, it is advisable to: ─ check the occurrence of system warnings ─ check the battery status, NOTE: If the last reforming, charge or shock occurred during the week preceding the interrogation, the last battery value may be still impacted by the event. One week post event, the battery will recover its steady state value.
17. PATIENT FOLLOW-UP ─ Markers: Atrial and ventricular markers, sensed, paced and in relative refractory periods, ─ EGM: onset and detection of the arrhythmia, on two therapies, and the return to slow rhythm by recording electrogram.
17. PATIENT FOLLOW-UP The defibrillator should be protected against mechanical impact and the temperature variations that may occur during shipping. Before explantation, it is advisable to: 17.5. ─ print out all programmed parameters, statistics and Holter function report, ─ save Patient data on floppy disk or hard disk, ─ disable shock therapies (VT and VF) to avoid any risk of untimely shock.
18. PHYSICAL CHARACTERISTICS 18. PHYSICAL CHARACTERISTICS 18.1. Dimensions 68.4 x 73.4 x 11 mm Weight 95 g Volume 38.6 cm3 Active surface area of casing 76 cm2 Connector Atrium: IS-1. Ventricle: DF-4. MATERIALS USED Active surface area of casing 99% pure titanium Connectors Polyurethane* and silicone elastomer* *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications.
19. ELECTRICAL CHARACTERISTICS 19. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 148 µF ± 8 % Capacitor formation No formation required Rate limit 192 bpm ± 10 bpm Pacing waveform Defibrillation waveform 19.1.
19. ELECTRICAL CHARACTERISTICS 19.3. Total capacity 1964 mAh Usable capacity Between BOS and RRT: 1278 mAh. Between BOS and EOS: 1675 mAh. Voltage BOS: 3.25 V. RRT: 2.66 V. EOS: 2.5 V. LONGEVITY The longevities mentioned below are calculated by taking into account 6 months storage. 6.0 years Pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock per quarter, sensor OFF 5.8 years Pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.
20. PROGRAMMABLE PARAMETERS 20. PROGRAMMABLE PARAMETERS measured at 37 °C under a 500 ohm load Legend: Value in bold: "as shipped" value Underlined value: nominal value 20.1.
20. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Atrial sensitivity (mV) (1) From 0.2 to 4 by steps of 0.2 ; 0.4 (± 50 %) Atrial amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Atrial pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Ventricular sensitivity (mV) (1) From 0.4 to 4 by steps of 0.2 ; 0.4 (± 50 %) Ventricular amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Ventricular pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.
20.
20. PROGRAMMABLE PARAMETERS 20.2.
20. PROGRAMMABLE PARAMETERS 20.3. 20.3.1 .
20. PROGRAMMABLE PARAMETERS ATP 2 program Values ATP program OFF-Burst-Burst+Scan-Ramp-Ramp+Scan Number of sequences 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.
20. PROGRAMMABLE PARAMETERS ATP 2 program Values ATP program OFF-Burst-Burst+Scan-Ramp-Ramp+Scan Number of sequences 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.
20. PROGRAMMABLE PARAMETERS Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) 20.4. 1-2-3-4 REMOTE ALERTS AND WARNINGS The device routinely performs security self-checks and technical measurements to ensure system integrity.
20. PROGRAMMABLE PARAMETERS 58 Clinical status Values V oversensing ON-OFF High AT/AF burden ON-OFF AT/AF limit (on 24h) (h) 0.5-1-3-6-12-24 Fast V Rate during AT/AF ON-OFF Fast V Rate limit (bpm) 80-90-100-110-120 Fast V Duration limit (h) 0.
21. NON PROGRAMMABLE PARAMETERS 21.
22. LIMITED WARRANTY 22. LIMITED WARRANTY The INTENSIA implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. Sorin Group Italia S.r.l.
22. LIMITED WARRANTY link to a component failure or a production hazard. The device battery longevity varies with the type and number of delivered therapies. 8. Legal requirements of jurisdictions where the INTENSIA device is distributed will supersede any warranty conditions indicated in this manual that conflict with such laws. 22.2. ARTICLE 2 : TERMS OF REPLACEMENT 1.
23. PATENTS 23.
24. EXPLANATION OF SYMBOLS 24. EXPLANATION OF SYMBOLS The symbols on product labelling have the following meaning: Use by Date of manufacture Manufacturer Serial number Batch number For single use only. Sterilised using ethylene oxide Temperature limitation High voltage Consult instruction for use. This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury.
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - Italy Tel: +39 0161 487095 Facsimile: +39 0161 487524 www.sorin.com Distributed by: Sorin CRM USA, Inc. 14401 West 65th Way Arvada, CO 80004 USA Tel: 877.663.
