Implantable cardioverter defibrillator VR models Implant manual
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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...............
15.4. Detection characteristics in the presence of electromagnetic fields........................................34 15.5. Protection against short-circuits..............................................................................................35 16. 16.1. 16.2. 16.3. 16.4. 16.5. 16.6. Main functions....................................................................................................................... 36 Automatic lead measurements.......................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION PLATINIUM VR is an implantable single-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. PLATINIUM VR is also equipped with the RF wireless technology which enables: ─ Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at home, ─ wireless interrogation and device programming by Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory.
2. INDICATIONS 2. INDICATIONS PLATINIUM VR 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 PLATINIUM VR 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 4.1. RISKS RELATED TO MEDICAL ENVIRONMENT It is advisable to carefully monitor defibrillator operation prior to and after any medical treatment during which an electrical current from an external source passes through the patient's body. Magnetic Resonance Imaging: MRI is strictly contraindicated in cardiac defibrillator patients. Radiofrequency ablation: A radiofrequency ablation procedure in a patient with a generator may cause device malfunction or damage.
4. WARNINGS AND PRECAUTIONS Diagnostic ultrasound (echography): The defibrillator is not affected by ultrasound imaging devices. Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted PLATINIUM VR should not use these devices. 4.2. STERILIZATION, STORAGE AND HANDLING Resterilization: Do not resterilize and re-implant explanted ICDs. "Use Before" Date: A "Use Before" date is printed on the outer storage package and on the sterile package.
4. WARNINGS AND PRECAUTIONS In the event of a warning on a low shock impedance, and after lead replacement or reconnection: it is recommended to check the system integrity (sensing and pacing thresholds and the impedance of the shock electrodes) It is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy.
4. WARNINGS AND PRECAUTIONS 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. If countershock is unsuccessful using external paddles, adjust the external paddle position (e.g.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the Defender study. PLATINIUM VR is similar in design and function to the Defender devices. The data provided are applicable to PLATINIUM VR. 5.1. DEFENDER STUDY Clinical study of Defender IV DR 612 included 60 devices implanted in 60 patients, 38 in Europe (37 patients followed for a minimum of 3 months), and 22 in the U.S. (IDE G970282/S15) with a total device exposure of 228.7 and 30.3 device months, respectively.
5. ADVERSE EVENTS * There were 228.7 device months in this study. Table 2: Summary of European Clinical Complications (Including Patient Complaints) 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.
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the Defender study. PLATINIUM VR is similar in design and function to the Defender devices. The data provided are applicable to PLATINIUM VR. 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.
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. DECLARATION OF CONFORMITY 9. DECLARATION OF CONFORMITY 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.
9. DECLARATION OF CONFORMITY This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry 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. 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 PLATINIUM 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 PLATINIUM VR 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 PLATINIUM VR can serve as a defibrillation electrode (active housing) with a total surface area of 63 cm².
13. DEVICE DESCRIPTION ─ Coil impedance, ─ Capacitor charge time, ─ Pacing threshold tests. ─ Data storage: ─ Therapy History Report, ─ Statistics (pace/sense, therapy, shocks, and battery voltage), ─ Up to 16 complete Holter records with event logs, marker channel notation, and electrogram records. The PLATINIUM VR 1210 connector has three ports: ─ ventricular bipolar pace/sense and ─ two ports for RV and 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. ─ if battery voltage is below 3V, and if the last reforming/charge occurred more than one week ago, do not implant the device.
14. IMPLANT PROCEDURE NOTE 1: Please note that DF-1 standard compliant lead is not compatible with DF4 connector. In the reverse, DF4 standard compliant lead is not compatible with DF-1 connector. In case of defibrillator replacement, choose the appropriate device compatible with DF-1 or DF4 leads. For 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 Sensing threshold: For appropriate ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. Pacing impedance measurement: Ventricular pacing impedance should range from 200 to 3000 ohms (refer to the lead characteristics, especially if high impedance lead is used). Please refer to the lead user manual for more details on the expected electrical performances of the leads. 14.10. LEAD CONNECTION Implant the ventricular lead.
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 can be felt as a solid metallic contact. Do not implant the defibrillator if there is no feeling of solid metallic contact.
14. IMPLANT PROCEDURE Save the programming data on the programmer’s hard disk and on an external storage device (if desired). Resuscitation Availability: Do not perform device testing unless an external defibrillator is available and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present. Disable the ICD During Handling: Program Shock Therapy to OFF during surgical implant and explant or post mortem procedures.
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 For DF4 models: ─ Common mode rejection ratio: For DF-1 Models: Ventricular channel 16.6 Hz 50 Hz 60 Hz ≥68 dB ≥68 dB ≥68 dB 16.6 Hz 50 Hz 60 Hz ≥68 dB ≥68 dB ≥68dB For DF4 Models: Ventricular channel For ventricular sensitivity settings below 0.6mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz. 15.5.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on the lead every 6 hours.The daily mean impedance is stored. Automatic coil impedance measurement: A continuity measurement is automatically performed on defibrillation coil(s) once per day. The continuity is stored for each coil. Automatic sensing measurement: The amplitude of R waves are automatically measured at each cycle.
16. MAIN FUNCTIONS 16.3. PACING BTO (Brady Tachy Overlap): Allows pacing in the slow VT zone, without affecting arrhythmia detection specificity. Post-shock mode: After any automatic shock therapy, the post-shock mode makes it possible to apply different pacing parameters. 16.4. SENSING Automatic Refractory Periods: Optimize sensing and make the implant programming easier. These periods are composed of a minimal Refractory Period and a triggerable Refractory Period.
16. MAIN FUNCTIONS The data is transmitted from the implant to the SMARTVIEW monitor, a small transmitter placed in the patient's home. Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then rooted through the phone line or via GPRS to an internet website. This website is responsible for transforming the implant data into a comprehensive report that can be consulted by the physician. 16.6.1.
16. MAIN FUNCTIONS 16.6.5.
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, NOTES: 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 For each episode four levels of details are presented: ─ Tachogram ─ Event log for the entire episode: ─ "Arrhythmia Discrimination" analysis for each majority, ─ Delivered therapies, ─ Markers: 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 ─ Cremation of the patient (the defibrillator may explode if placed in an incinerator) The explanted defibrillator should not be reused in another patient. All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces of contamination. Cleaning may be done by immersing them in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by rinsing copiously with water.
18. PHYSICAL CHARACTERISTICS 18. PHYSICAL CHARACTERISTICS 1210 MODEL: Dimensions 73 x 54.3 x 11.1mm Weight 85 g Volume 33 cm3 Active surface area of casing 62.7cm2 Connector IS-1 bipolar, 2*DF-1. 1240 MODEL: 18.1. Dimensions 65.8 x 54.3 x 11.1 mm Weight 84 g Volume 31.2 cm3 Active surface area of casing 62.9cm2 Connector DF4.
19. ELECTRICAL CHARACTERISTICS 19. ELECTRICAL CHARACTERISTICS Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 149 µF ± 8 % Capacitor reformation No reformation required Rate limit 192 ppm ± 10 ppm Pacing waveform Defibrillation waveform 19.1.
19. ELECTRICAL CHARACTERISTICS 19.3. Usable capacity Between BOS and RRT: 1530 mAh. Between BOS and EOS: 1910 mAh. Voltage BOS: 3.24 V. RRT: 2.62 V. EOS: 2.5 V.
19. ELECTRICAL CHARACTERISTICS Basic Rate (ppm) 60 60 60 60 60 40 60 V pacing (%) 100 100 1 15 15 6 0 Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 - Pulse width (ms) 0.35 0.35 0.35 0.50 0.35 0.35 - Sensor OFF ON OFF OFF OFF OFF OFF Max shocks (42J) per year 4 4 4 4 0 4 4 Longevity (years) 11.5 11.1 14.1 13.1 17.7 14.3 14.
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 48 3.5 3,65 3,09 4 4,2 3,55 4,5 4,69 3,97 5 5,25 4,44 6 6,3 5,33 Post-shock mode Values Mode OFF-VVI Duration 10s-20s-30s-1min-2min-3min-4min-5min Basic rate (ppm) From 50 to 90 by steps of 5 ; 60 (± 4 %) V amplitude (V) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) V pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Sensitivity margins Values Ventricular post pacing margin (mV) From 0 to 2 by steps of 0.2 ; 0.
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.
21. NON PROGRAMMABLE PARAMETERS 21. NON PROGRAMMABLE PARAMETERS Ventricular refractory periods Values Post ventricular sensing 95 ms (± 16 ms) Post ventricular pacing 220 ms (± 4 ms) Therapies Values Waveform (1) Constant tilt (50% - 50%) Stored energy for the Max. shock 42 J Pacing amplitude during ATP therapies 7 V (Actual value at 300 ms: 5.3 V ) (1) The device has 50% tilt in each phase thus delivers 94% of stored energy. Each phase is limited to 10 ms duration.
22. LIMITED WARRANTY 22. LIMITED WARRANTY The PLATINIUM implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. The terms of the limited warranty are available upon request from your Sorin representative or on the CD-ROM of the package content.
23. PATENTS 23.
24. EXPLANATION OF SYMBOLS 24.
24. EXPLANATION OF SYMBOLS Non sterile Temperature limitation Torque wrench Consult instructions for use Instructions for use in the CD-ROM 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. Carefully read the instructions provided with this icon.
BACKCOVER CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2015-03 U461A © 2015 Sorin CRM SAS
