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 ..........
13. Device description....................................................................35 14. Implant procedure ....................................................................38 14.1. Necessary equipment ....................................................38 14.2. Packaging .......................................................................39 14.3. Optional equipment .......................................................39 14.4. Before opening the package .......................................
18. Physical characteristics ..........................................................61 18.1. Materials used ................................................................61 19. Electrical characteristics .........................................................62 19.1. Table of delivered shock energy and voltage .............63 19.2. Battery .............................................................................64 19.3. Longevity ...................................................................
1. GENERAL DESCRIPTION PARADYM RF DR 9550 is an implantable dual-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 leads 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.
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 PARADYM RF DR 9550 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.
4.3. 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 DR 9550 has two DF-1 and two 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 leads. While the ICD is connected to the leads, 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 and SafeR clinical studies. PARADYM RF DR 9550 is similar in design and clinical function to the Defender devices. SafeR operation in PARADYM RF is similar to that in the Symphony pacemaker. The data provided are applicable to PARADYM RF DR 9550. 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.
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.
Event # of Patients* % of Patients # of Events Events/100 DeviceYears** 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 2.6 1 5.2 Sensor acceleration during telemetry*** 1 2.6 1 5.2 Shock for VT in VF Zone 1 2.6 1° 5.2 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.
5.2. SAFER STUDY Clinical study of the SafeR included 45 Symphony 2550 devices implanted in 45 patients. No serious adverse events were device- or feature-related. There were no deaths in the study. Table 1 summarizes the safety data for this study.
Patients Number of events Number of patients % of patients Number of events Events per device year (a) Non-serious events related due to the use SafeR 13 28.9 15 3.2 Serious nonpacemaker related events 6 13.3 9 1.9 Non-serious non-pacemaker related events 8 17.8 8 1.7 (a) 4.
6. CLINICAL STUDIES Clinical data presented in this section are from the Defender and SafeR clinical studies. PARADYM RF DR 9550 is similar in design and function to the Defender devices. SafeR operation in PARADYM RF is similar to that in the Symphony pacemaker. The data provided are applicable to PARADYM RF DR 9550. 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. 6.2.
During atrial fibrillation episode, pause criterion is fixed to 2s to avoid long bradycardia episodes in switching to DDD mode. Despite these differences, the data collected on Symphony devices are applicable to PARADYM RF because the principles of SafeR operation did not change. The 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.
Thirty-five patients contributed data to evaluate the percentage of ventricular pacing provided with SafeR. Twenty-nine patients had 1 % or less ventricular pacing and six patients had a range of 28-97 % ventricular pacing. The graph below shows the distribution of ventricular pacing observed in patients with and without AV block as a primary indication for implant. The graph shows that many patients programmed to SafeR had less than 1% ventricular pacing: 84 % of patients without AV block at implant.
In a representative reference group (1) of patients programmed to DDD, none had less than 1 % ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV block indication at implant. The actual reduction of ventricular pacing that SafeR provides in an individual will depend on the amount of time that the patient spends in AV block. SafeR cannot and should not provide any decrease in ventricular pacing while the patient is in AV block.
Table 1: Summary of Symphony safety data during study Patients Number of events Number of patients % of patients Number of events Events per device year (a) Deaths 0 0 0 0 Explants 0 0 0 0 Serious pacemaker related events outside the use of SafeR 0 0 0 0 Non-serious pacemaker related events outside the use of SafeR 0 0 0 0 Serious events due to the use of SafeR 0 0 0 0 Non-serious events related due to the use SafeR 13 28.9 15 3.
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.
Drug resistant supraventricular tachyarrhythmias (SVTs): Drug resistant supraventricular tachyarrhythmias (SVTs) may initiate frequent unwanted device therapy. A careful choice of programming options is necessary for such patients. 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.
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.
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 YSGDR9550. 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.
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.
"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. Additional copies can be obtained by contacting your Sorin CRM representative or on the Sorin CRM'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.
The PARADYM RF DR 9550 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm². The PARADYM RF DR 9550 is designed to recognize and treat slow or fast VT and VF by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
The PARADYM RF DR 9550 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.
Up to 14 complete Holter records with event logs, marker channel notation, and electrogram records. The connector head has four ports: atrial bipolar pace/sense, ventricular bipolar pace/sense and two ports for RV and SVC defibrillation coils. Both pace/sense ports are compatible with the IS1 standard and both defibrillation ports are compatible with the DF-1 standard. Distal lead terminal connections are secured with setscrews accessed via self-sealing silicone plugs.
14.2. PACKAGING Contents The PARADYM RF DR 9550 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.
Devices MUST NOT be interrogated and programmed within the vicinity of other devices. 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.
14.7. CHOOSING THE TYPE OF LEAD The defibrillator should be connected to: one bipolar atrial sensing/pacing lead 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. Note: In case no atrial lead is implanted, the atrial port should be plugged with IS-1 insulating plug and a single chamber mode (VVIVVIR) should be programmed.
Programming: When active case and SVC are both programmed to Yes, the shock configuration can be programmed to: 1. RV to Case (or Case to RV), 2. RV to SVC (or SVC to RV), 3. RV to Case+SVC (or Case+SVC to RV). The polarity of shock is determined by the parameter itself. RV to Case+SVC RV to Case RV to SVC 14.8. MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant. Pacing thresholds: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.
14.9. 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. Clean the lead terminal pins thoroughly, if necessary (device replacement). 2. Lubricate the lead terminal pins with sterile water, if necessary. 3.
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.
14.10. DEVICE IMPLANTATION PARADYM RF DR 9550 should be implanted with the engraved side facing outwards for optimal communication with the programming head and radiographic identification. Place the device in the pocket. Once in place, the defibrillator should be no more than 4 cm below the skin surface. Carefully wind excess lead and place in a separate pocket to the side of the defibrillator. It is recommended to not place any excess wire between the can and the heart.
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.
The magnet rate values are as follow: Magnet rate (bpm) 96 94 91 89 87 85 Magnet period (ms) 625 641 656 672 688 703 Magnet rate (bpm) 83 82 80 78 77 Magnet period (ms) 719 734 750 766 781 15.3. RESPONSE IN THE PRESENCE OF INTERFERENCE If the defibrillator senses electrical noise at a frequency above 16 Hz, it switches to an asynchronous mode at the basic rate. The programmed mode is restored as soon as the noise is no longer detected.
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 67 dB 67 dB Ventricular channel ≥ 69 dB ≥ 69 dB ≥ 69 dB Modulated interference: For atrial sensitivity setting of 0.
15.5. PROTECTION AGAINST SHORT-CIRCUITS The defibrillator can undergo a short-circuit if the anode and cathode are not adequately separated. In this case, the shock is aborted to prevent damaging the defibrillator and a warning will indicate that a short circuit (shock impedance < 20 ohms) was detected during the last shock. 16. MAIN FUNCTIONS 16.1.
16.3. VENTRICULAR TACHYARRHYTHMIA MANAGEMENT Ventricular tachyarrhythmia prevention: Set of algorithms that can be used to avoid the circumstances of ventricular tachyarrhythmia onset. Searching for a long cycle (P And R based Arrhythmia Detection+: PARAD+): Additional arrhythmia classification criterion to improve identification of atrial fibrillation and avoid inappropriate shocks.
16.4. PACING BTO (Brady Tachy Overlap): Corrects chronotropic atrial incompetence by allowing pacing in the slow VT zone, without affecting detection specificity. Post-shock mode: After any automatic shock therapy, the postshock 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.
detected. Ventricular pacing can be inhibited to avoid a potential paced T-wave. Automatic sensitivity control: Optimizes arrhythmia detection and avoids late detection of T-waves and over-detection of wide QRS waves. The device automatically adjusts the sensitivities based on the ventricular sensing amplitude. In case of arrhythmia suspicion or after a paced event, the programmed ventricular sensitivity will be applied. The minimum ventricular sensitivity threshold is 0.4 mV (minimum programmable value).
16.7. REMOTE MONITORING FUNCTION Remote monitoring enables the automatic remote transmission of implant data to the physician thanks to the wireless Radio Frequency (RF) communication ability of the implant in order to provide a comprehensive report to the physician about device functioning and patient cardiac status without having the patient physically in the clinic. The data is transmitted from the implant and the SMARTVIEW monitor, a small transmitter placed in the patient home.
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 up to 14 tachyarrhythmia episodes as well as the therapy history. STORED EPISODES PARADYM RF DR 9550 stores up to 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 DR 9550 can still function for: 8.4 months (100% atrial and ventricular pacing in DDD mode, 500 ohms, with as-shipped 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 Atrium: IS-1. Ventricle: IS-1, DF-1. 18.1.
19. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % 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. 6.0 years Pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensor OFF 5.
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.
Special features Values Smoothing OFF-Very slow-Slow-Medium-Fast Mode Switch ON-OFF Mode Switch Rate (min-1) From 30 to 90 by steps of 5 ; 60 Anti-PMT protection Termin-Reprog Physical activity Very low-Low-Medium-High-Very high US-ENGLISH – 67
Pacing/Sensing Atrial sensitivity (mV) Values From 0.2 to 4 by steps of 0.2 ; 0.4 (± 50 %) (1) 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.
Ventricular arrhythmia prevention Values Atrial pacing on PVC Yes-No Post extrasystolic pause suppression Yes-No Acceleration on PVC Yes-No Max accelerated rate (min-1) From 60 to 145 by steps of 5 ; 100 Post-shock mode Values Mode OFF-VVI-DDI-DDD Duration 10s-20s-30s-1min-2min-3min-4min-5min Basic rate (min-1) From 50 to 90 by steps of 5 ; 60 (± 4 %) Rest AV delay (ms) 30-40-45-55-65-70-80-85-95-100-110115-125-135-140-150-155-165-170-180190-195-205-210-220-225-235-250 (± 19 ms) Exercise
Refractory periods Values Atrial refractory period post ventricular sensing (ms) 45-65-80-95-110-125-140-155 (± 16 ms) Atrial refractory period post ventricular pacing (ms) 80-95-110-125-140-155 (± 4 ms) Sensitivity margins Values Atrial post pacing/sensing margin (mV) From 0 to 1 by steps of 0.2 ; 0.4 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-PARADPARAD+ 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 30-45-65-80-95-110-125-125 VT (ms) 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 st
20.3.
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 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.
Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-56-7-8-9- (± 30 %) 10-12-14-16-18-20-22-24-26-28-30-3234-42 (± 15 %) Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-56-7-8-9- (± 30 %) 10-12-14-16-18-20-22-24-26-28-30-3234-42 (± 15 %) Number of Max.
Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-56-7-8-9- (± 30 %) 10-12-14-16-18-20-22-24-26-28-30-3234-42 (± 15 %) Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-56-7-8-9- (± 30 %) 10-12-14-16-18-20-22-24-26-28-30-3234-42 (± 15 %) Number of Max. Shock (42 J) 1-2-3-4 20.4. REMOTE ALERTS AND WARNINGS General parameters Values RF communication ON-OFF (1) Remote alerts (1) ON-OFF (1) RF and Remote alerts are turned on automatically if Shocks are programmed ON.
Lead Alerts Values Abnormal A lead impedance ON-OFF Abnormal A lead low limit (Ohm) 200-250-300-350-400-450-500 Abnormal A lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal V lead impedance ON-OFF Abnormal V lead low limit (Ohm) 200-250-300-350-400-450-500 Abnormal V lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal RV coil impedance ON-OFF Abnormal SVC coil impedance ON-OFF Abnormal Shock impedance (1) ON-OFF (1) Normal impedance range [20 Ohm-200 Ohm] Clinical status Valu
21.
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 YSGDR9550 IC : 10270A-DR9550 Last revision date of this manual: 2012-05 US-ENGLISH – 85