TABLE OF CONTENTS 1. General description ....................................................................6 2. Indications...................................................................................6 3. Contraindications .......................................................................6 4. Warnings and precautions ........................................................7 4.1. Risks related to medical environment ...........................8 4.2. Sterilization, storage and handling ..........
12. How supplied ............................................................................30 12.1. Sterility ............................................................................30 12.2. Warranty and replacement policy ................................30 13. Device description....................................................................31 14. Implant procedure ....................................................................33 14.1. Necessary equipment ....................................
17. Patient follow-up.......................................................................47 17.1. Follow-up recommendations ........................................47 17.2. Holter function................................................................48 17.3. Elective Replacement Indicator (ERI) ..........................49 17.4. Explantation....................................................................50 17.5. Defibrillator identification .............................................51 18.
1. GENERAL DESCRIPTION PARADYM RF VR 9250 is an implantable single-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. 2.
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.
Communication equipment: Communication equipment such as microwave transmitters, linear power amplifiers, or high-power amateur transmitters may generate enough EMI to interfere with defibrillator operation if approached too closely. Home appliances: Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with defibrillator operation.
Electrocautery or diathermy device: Diathermy and electrocautery equipment should not be used. If such devices must be used: 1. Keep the current path and ground plate as far away from the device and the lead as possible (a minimum of 15 cm [six inches]). 2. Before procedure, deactivate ATP and shock therapies. 3. During the procedure, keep the electrocautery device as far as possible from the cardiac defibrillator. Set it at minimum intensity. Use it briefly. 4.
Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted PARADYM RF VR 9250 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. Do not implant the device after this date because the battery may have reduced longevity and sterility may be affected.
4.3. IMPLANTATION AND DEVICE PROGRAMMING Use only a Sorin CRM programmer to communicate with the device. Do not position any magnet over the ICD; this suspends tachyarrhythmia detection and treatment. Replace the device when the programmer displays an ERI* (defined by a battery voltage of 2.66 ± 0.01 V or a magnet rate lower than or equal to 80 bpm). Program device parameters such as sensitivity threshold and VT and VF detection intervals as specified in the device manuals.
4.4. LEAD EVALUATION AND LEAD CONNECTION PARADYM RF VR 9250 has two DF-1 and one IS-1 connector ports. IS-1 refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit (ISO 5841-1:2000). DF-1 refers to the international standard for defibrillation lead connectors (ISO 11318:2002). Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessive strain at the insertion site as this may damage the lead.
Lead electrodes in contact during a cardioversion or defibrillation therapy will cause current to bypass the heart, possibly damaging the ICD and the lead. While the ICD is connected to the lead, make sure that the metal portions of any electrodes do not touch each other. If a pacing lead is abandoned rather than removed, it must be capped to ensure that it is not a pathway for currents to or from the heart.
5. ADVERSE EVENTS Clinical data presented in this section are from the Defender study. PARADYM RF VR 9250 is similar in design and function to the Defender devices. The data provided are applicable to PARADYM RF VR 9250. 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.
Two of the 38 Defender IV DR 612 patients in Europe (37 patients followed for a minimum of 3 months) experienced a total of three complications, including device failures and replacements. Fourteen of the 38 Defender IV DR 612 patients experienced a total of 18 observations. Complications and observations are reported in Tables 1 and 2. It should be noted that a patient can have more than one observation or complication. There were no observations or complications in the U.S. 5.2.
5.3. 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° 10.5 Pocket infection/hematoma 1 2.6 1° 5.
Event # of Patients* % of Patients # of Events Events/100 DeviceYears** Slow VT not converted by ATP therapy 1 2.6 2° 10.5 Unsatisfactory sensing threshold test*** 2 5.3 2 10.5 Ventricular oversensing 3 7.9 3 15.7 * A patient can have more than one observation. ** There were 228.7 device months in this study. ***These observations would not have happened with the currently marketed device and programmer.
6. CLINICAL STUDIES Clinical data presented in this section are from the Defender study. PARADYM RF VR 9250 is similar in design and function to the Defender devices. The data provided are applicable to PARADYM RF VR 9250. 6.1.
Study Population. The table below summarizes inclusions.
Rate response European patients only: GROUP Number of patients included Mean slope %SRR on %MR STD of slopes %SRR on %MR SE of mean slope %SRR on %MR Lower 95% CI Upper 95% CI Europe 20 0.77 0.17 0.04 0.69 0.84 Small Centers 9 0.79 0.18 0.06 0.67 0.91 Large Centers 11 0.75 0.15 0.05 0.66 0.84 Males 17 0.77 0.16 0.04 0.70 0.85 Females 3 0.73 0.22 0.13 0.47 0.
Adverse events Event US (N=22) Number of events* Number of patients Percent of patients Intent to treat but did not 0 0 0.0 Non-device related death 0 0 0.0 Explant 0 0 0.0 Complication 0 0 0.0 Observation 0 0 0.0 Serious nonrelated other than death 1 1 4.5 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.
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 3.3 Observation 18 14 23.3 Serious nonrelated other than death 13 8 13.3 * A patient can have more than one complication, observation, or serious adverse event, not device-related. Device Failures and Replacements: No device failures or replacements occurred with Defender IV DR 612 during the study.
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.
Antiarrhythmic drug therapy: If the patient is being treated with antiarrhythmic or cardiac drugs, the patient should be on a maintenance drug dose rather than a loading dose at the time of ICD implantation. If changes to drug therapy are made, repeated arrhythmia inductions are recommended to verify ICD detection and conversion. The ICD also may need to be reprogrammed.
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 CRM ID cards and/or ID bracelets documenting their ICD system. 9.
IEC 60601-1-2 (2007): Electromagnetic compatibility - Medical electrical equipment. General requirements for basic safety and essential performance - Collateral standard EN 50371 (2002) : Generic standard to demonstrate the compliance of low power electronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields (10 MHz - 300 GHz) EN 301 489-1 (v1.8.1) & EN 301 489-27 (v1.1.
Sorin CRM 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 YSGVR9250. 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.
used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited.
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.
It has been stored or transported outside the environmental temperature limits: 32 °F (0 °C) to 122 °F (50 °C) as an electrical reset condition may occur. "Use Before" date has expired, because this can adversely affect pulse generator longevity or sterility. 11. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in the outer storage package.
13. DEVICE DESCRIPTION The PARADYM RF VR system includes the model 9250 ICD device and programming system. The programming system includes the Sorin CRM Orchestra Plus programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin CRM. The PARADYM RF VR 9250 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm².
The PARADYM RF VR 9250 offers biphasic shocks with a maximum stored energy of 42 J. The shock configuration (electrodes used to apply the shock) can be chosen by programming one of the following combinations: can and one coil, can and 2 coils, 2 coils only.
The connector head has three ports: ventricular bipolar pace/sense and two ports for RV and SVC defibrillation coils. The pace/sense port is compatible with the IS-1 standard and both defibrillation ports are compatible with the DF-1 standard. Distal lead terminal connections are secured with set-screws accessed via self-sealing silicone plugs. All lead connections pass through the header into the device via feedthroughs.
14.2. PACKAGING Contents The PARADYM RF VR 9250 and its accessories are ethylene oxide sterilized and hermetically sealed in two-ply clear packaging meeting international requirements. The sterile packaging contains a defibrillator, one screwdriver, and an insulating plug for the DF-1 defibrillation connector. The non-sterile items contained in the outer storage package are the implant manual, the ICD Registration Form and its envelope, the patient booklet, the ICD ID card and 12 identification labels.
Also check the integrity of the sterile package. The sterility of the contents is no longer guaranteed if the package has been pierced or altered. If the defibrillator is no longer sterile, it should be returned in its packaging to Sorin CRM. Any re-sterilization of the unit is at the discretion of Sorin CRM. 14.5. PRIOR TO IMPLANTATION Use the programmer to verify the defibrillator can be interrogated before implantation.
14.7. CHOOSING THE TYPE OF LEAD The defibrillator should be connected to: one ventricular defibrillation lead with sensing/pacing bipolar electrodes, and one or two defibrillation electrodes. The choice of leads and their configuration is left to the implanting physician’s judgment. Connectors: The bipolar pacing/sensing connector is compliant with the IS-1 standard and the defibrillation connectors are compliant with the DF-1 standard.
14.8. MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant. Pacing threshold: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width. Sensing threshold: For proper 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). 14.9.
CAUTION: 1. One single set screw is located on the side of the connection header. 2. Do not tighten the pre-inserted screws when there is no lead (this could damage the connector). 3. Do not loosen the screws before inserting the connector (subsequent risk of being unable to reinsert the screw). 4. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold the screwdriver by its metal part and not by the handle. 5.
Suture the casing connector to the muscle using the hole provided for this purpose, in order to avoid potential migration of the device into the pectoral muscle. 14.11. TESTS AND PROGRAMMING During the implant testing procedure, it is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy. Enable shock therapies, then program the defibrillator.
15.2. MAGNET MODE When the magnet is applied: antiarrhythmia functions are inhibited (detection of rhythm disturbances, charging, and therapy), pacing amplitude is set to 6 V, pulse width is set to maximum, pacing rate is set to the magnet rate, the following functions are disabled: Smoothing, Rate Response.
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: Ventricular channel 16.6 Hz 50 Hz 60 Hz ≥ 69 dB ≥ 69 dB ≥ 69 dB 15.5. PROTECTION AGAINST SHORT-CIRCUITS The defibrillator can undergo a short-circuit if the anode and cathode are not adequately separated.
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 coil impedance measurement is automatically performed on RV and SVC coils once a week. The result is stored in the device memory. 16.2.
16.4. SENSING Automatic Refractory Periods: Optimize sensing and make the implant progamming easier. These periods are composed of a minimal Refractory Period and a triggerable Refractory Period. The duration of the refractory periods lengthens automatically as needed. Protection against noise: Allows the distinction between ventricular noise and ventricular fibrillation. If the device senses ventricular noise, the ventricular sensitivity is decreased until noise is no longer detected.
For example, the following types of event can trigger a warning or an alert: technical problem during a shock, pacing lead impedance or coil impedance measurements out-of-range, battery depletion,… 16.6.
Transmission trigger There are 3 different triggers for a remote transmission: the remote follow-up transmission is scheduled by the physician to occur regularly (according to the programming). the alert transmission will take place when the implant has recorded an abnormal event. The list of abnormal event is available in a following paragraph. Alert conditions are checked daily.
User website On the website, the physician is able to: consult and schedule the remote follow-ups of their patient configure additional ways of being notified of alerts (for instance by SMS, fax or e-mail) consult, print and export patient reports Alert system The following set of alert trigger can be independently programmed ON/OFF by the physician using the Orchestra Plus programmer and can trigger an alert transmission: Reset of the device ERI reached Low or high impedance (A, RV, LV)
17. PATIENT FOLLOW-UP 17.1.
17.2. HOLTER FUNCTION The Holter records 14 tachyarrhythmia episodes as well as the therapy history. STORED EPISODES PARADYM RF VR 9250 stores 14 episodes (VF, VT, Slow VT, SVT/ST, nonsustained).
17.3. ELECTIVE REPLACEMENT INDICATOR (ERI) Elective Replacement Indicators (ERI)(1) are: magnet rate equal to 80 ± 1 min-1 or battery voltage equal to 2.66 V ± 0.01 V CAUTION: The defibrillator should be replaced as soon as the Elective Replacement Indicator (ERI) point is reached. Between the ERI and the EOL (End of Life)(2), PARADYM RF VR 9250 can still function for: 9.7 months (100% pacing in VVI mode, 500 ohms, with asshipped settings), and deliver 7 shocks at 34 J or 6.
17.4. EXPLANTATION The defibrillator should be explanted in the following cases: The Elective Replacement Indicator (ERI) point is reached Confirmed malfunction Burial of the patient (for environmental reasons, the local regulation may require the explantation of the devices containing a battery supply) Cremation of the patient (the defibrillator may explode if placed in an incinerator) The explanted defibrillator should not be reused in another patient.
17.5. DEFIBRILLATOR IDENTIFICATION The defibrillator can be interrogated and programmed via telemetry, using the programming head interfaced with the Sorin CRM dedicated programmer. Position the programming head over the telemetry antenna located in the upper part of the device, in order to communicate effectively via telemetry (see diagram below). The device can be non-invasively identified as follows: 1.
18. PHYSICAL CHARACTERISTICS Dimensions 69.5 x 73.4 x 11 mm Weight 95 g Volume 38.6 cm3 Active surface area of casing 76 cm2 Connector IS-1, DF-1 18.1. MATERIALS USED Active surface area of casing 99% pure titanium Connectors Polyurethane* and silicone elastomer* DF-1 insulating plug silicone elastomer* *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications.
19. ELECTRICAL CHARACTERISTICS Ventricular input impedance 80 kilohms ± 30 % D.C.
19.1. TABLE OF DELIVERED SHOCK ENERGY AND VOLTAGE The relationship between stored energies, maximum voltages and delivered energies (at 37 °C, 50 ohm load) for the minimum, low, mean and maximum programmed energy values is as follows: Stored energy (J) 0.5 10 20 34 42 V1 (Volt) 75 341 483 631 702 V2 (Volt) 37 173 245 318 353 Delivered E: Phase 1 (J) 0.31 7.0 14.0 23.9 29.6 Delivered E: Phase 2 (J) 0.08 1.8 3.6 6.1 7.5 Delivered E: Total (J) 8.8 17.6 30.0 37.1 0.
19.2. BATTERY Manufacturer Greatbatch Type Quasar High Rate (QHR) Model GB 2593 Number of batteries 1 Total capacity 1964 mAh Usable capacity Between BOL and ERI: 1278 mAh. Between BOL and EOL: 1675 mAh. Voltage BOL: 3.25 V. ERI: 2.66 V. EOL: 2.5 V. 19.3. LONGEVITY The longevities mentioned below are calculated by taking into account 6 months storage. 7.3 years Pacing in VVI mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensor OFF 7.
The mean longevity as a function of shocks delivered at maximum energy, with and without pacing, is as follows: The mean longevity as a function of yearly remote follow-ups(1), with and without pacing, is as follows: (1) An excessive number of remote follow-up can have a nonnegligible impact on device longevity.
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. ANTIBRADYCARDIA PACING Basic parameters Values Mode VVI-VVIR Basic rate (min-1) (1) From 30 to 90 by steps of 5; 60 (± 4 %) Maximum rate (min-1) From 100 to 145 by steps of 5; 120 (± 6 %) Rate hysteresis (%) 0-5-10-20-35 (± 18 ms) (1) The corresponding periods are (in ms): 2000-1714-1500-1333-1200-10911000-923-857-800-750-706-667 ms.
Special features Values Smoothing OFF-Very slow-Slow-Medium-Fast Physical activity Very low-Low-Medium-High-Very high Pacing/Sensing Values 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) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) (1) Values are measured using a positive and negative triangular signal of 2/13 ms.
Post-shock mode Values Mode OFF-VVI Duration 10s-20s-30s-1min-2min-3min-4min5min Basic rate (min-1) 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.
20.2.
Detection criteria Values Slow VT and VT detection criteria Rate Only-Stability-Stability+Stability/Acc-Stability+/Acc Fast VT detection criteria Rate+Stability-Rate Only Majority: (X/Y), Y (cycles) 8-12-16 Majority: (X/Y), X (%) 65-70-75-80-90-95-100 Window of RR stability for Slow VT and VT (ms) 30-45-65-80-95-110-125-125 Window of RR stability for fast VT (ms) 30-45-65 Prematurity acceleration (%) 6-13-19-25-31-38-44-50 Long cycle persistence extension (cycles) From 0 to 16 by steps of 1;
Therapy parameters in slow VT zone ATP 1 program Values ATP program OFF-Burst-Burst+Scan-RampRamp+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.
ATP 2 program Values ATP program OFF-Burst-Burst+Scan-RampRamp+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.
Therapy parameters in VT zone ATP 1 program Values ATP program OFF-Burst-Burst+Scan-RampRamp+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.
ATP 2 program Values ATP program OFF-Burst-Burst+Scan-RampRamp+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.
Therapy parameters in fast VT / VF zone ATP 1 program Values ATP program OFF-Burst-Burst+Scan-RampRamp+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 10s-20s-30s-1min-1.
20.4. REMOTE ALERTS AND WARNINGS General parameters Values RF communication (1) ON-OFF Remote alerts (1) ON-OFF (1) RF and Remote alerts are turned on automatically if Shocks are programmed ON.
Clinical status Values V oversensing ON-OFF Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shockInefficient max shock 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 Constant tilt (50% - 50%) Stored energy for the Max. shock 42 J (± 15 %) Pacing amplitude during ATP therapies 7 V (Actual value at 300 ms: 5.
22. LIMITED WARRANTY The PARADYM RF implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. Sorin CRM S.r.l.
4. The limited guarantee only applies to suspect devices returned to the manufacturer, carefully packed and accompanied by an explantation report duly completed by the hospital or the doctor and considered defective after analysis by Sorin CRM. The device must be returned within the 30 days following explantation to Sorin CRM. Any device returned and replaced under the terms of this limited warranty will become the exclusive property of Sorin CRM.
22.2. ARTICLE 2 : TERMS OF REPLACEMENT 1. In case of PARADYM RF failure because of a component failure, a production defect, or a conception error, occurring within twoyear period starting from the implantation date, Sorin CRM is committed to: replacing free of charge the explanted device by a Sorin CRM device with equivalent features, or issuing a replacement credit equal to the purchase price for the purchase of any other Sorin CRM replacement device. 2.
23.
24. EXPLANATION OF SYMBOLS The symbols on product labelling have the following meaning: Use by Date of manufacture Serial number Batch number For single use only Sterilised using ethylene oxide Temperature limitation High voltage Consult instruction for use.
FCC ID YSGVR9250 IC : 10270A-VR9250 Last revision date of this implant manual: 2012-03 74 – US-ENGLISH