TABLE OF CONTENTS 1. General description ............................................................... 5 2. Indications .............................................................................. 5 3. Contraindications ................................................................... 6 4. 4.1. 4.2. 4.3. 4.4. 4.5. Warnings and precautions .................................................... 6 Risks related to medical environment .................................
14.1. Necessary equipment .......................................................... 35 14.2. Packaging ............................................................................. 36 14.3. Optional equipment ............................................................. 36 14.4. Before opening the package ............................................... 37 14.5. Prior to implantation ............................................................ 37 14.6. Device placement ......................................
18.1. Adverse events in the safer study ...................................... 60 18.2. Safer Clinical study .............................................................. 63 19. Physical characteristics ...................................................... 66 19.1. Materials used ...................................................................... 66 20. 20.1. 20.2. 20.3. Electrical characteristics ..................................................... 67 Table of delivered shock energy and voltage ....
1. GENERAL DESCRIPTION PARADYM RF SonR CRT-D 9770 is an implantable cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation, with ventricular resynchronization, in patients with spontaneous or inducible tachyarrhythmias. PARADYM RF SonR CRT-D 9770 is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity.
3. CONTRAINDICATIONS Implantation of PARADYM RF SonR CRT-D 9770 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.
Resuscitation Availability: Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are readily available. Electrical Isolation: Do not permit the patient to contact grounded equipment that could produce hazardous leakage current. Ensuing arrhythmia induction could result in the patient’s death. Disable the ICD During Handling: Program Shock Therapy to OFF during surgical implant and explant or post mortem procedures.
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.
External defibrillation: PARADYM RF SonR CRT-D 9770 is protected from external defibrillation shocks. Before external defibrillation, deactivate ATP and shock therapies. During external defibrillation, it is advisable to avoid placing the defibrillating paddles directly over the casing or over the leads. The defibrillating paddles should preferably be placed in an anteroposterior position.
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. It should be returned to Sorin CRM.
Lead System: Do not use a lead system other than those with demonstrated compatibility because undersensing cardiac activity and failure to deliver necessary therapy may result. In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed.
4.4. LEAD EVALUATION AND LEAD CONNECTION PARADYM RF SonR CRT-D 9770 has two DF-1, two IS-1 connector, and one sonR connector ports. The sonR connector port has been specifically designed by Sorin CRM to accept three connections (tripolar). The two distal connections respect the same dimensions as the IS-1 standard, and an additional proximal connection allows to connect the sonR signal.
Do not insert a lead connector pin into the connector block without first visually verifying that the setscrews are sufficiently retracted. Do not tighten the setscrews unless a lead connector pin is inserted because it could damage the connector block. Lead electrodes in contact during a cardioversion or defibrillation therapy will cause current to bypass the heart, possibly damaging the ICD and the leads.
Never incinerate the device due to the potential for explosion. The device must be explanted before cremation. 5. ADVERSE EVENTS Clinical data presented in this section are from the MSP clinical study. PARADYM RF SonR CRT-D is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PARADYM RF SonR CRT-D. 5.1. MSP STUDY Sorin CRM conducted an international, multi-center, randomized clinical trial of its cardiac resynchronization therapy system.
Event # of Patients % of Patients # of Events Events/ 100 DeviceYears Deaths not related to the system 16 8.4 16 0.8 Cardiac arrest 5 2.6 5 0.3 Worsening CHF / CHF decompensation 3 1.6 3 0.2 Multi-organ dysfunction 2 1.1 2 0.1 Complications related to the 28 system 14.7 35 2.1 Dislodgment or migration 9 4.7 11 0.6 Extracardiac stimulation (e.g., phrenic stim) 9 4.7 9 0.5 Complications related to the 18 implant procedure 9.5 21 1.3 Dislodgment or migration 4 2.
Event # of Patients % of Patients # of Events Events/ 100 DeviceYears Serious adverse events not related to the system 85 44.7 176 10.8 Worsening CHF/CHF decompensation 24 12.6 42 2.1 Atrial fibrillation/flutter 14 7.4 14 0.7 Not Serious events not related to the system 58 30.5 121 7.4 Pain (in back, arms, chest, shoulder, groin, head, other) 10 5.3 13 0.7 Worsening CHF/CHF decompensation 13 6.8 16 0.8 Atrial fibrillation/flutter 7 3.7 8 0.
─ ─ ─ ─ ─ ─ ─ ─ ─ Formation of hematomas or cysts, Inappropriate shocks, Infection, Keloid formation, Lead abrasion and fracture, Lead migration/dislodgment, Myocardial damage, Pneumothorax, Shunting current or insulating myocardium during defibrillation with internal or external paddles, ─ Potential mortality due to inability to defibrillate or pace, ─ Thromboemboli, ─ Venous occlusion, ─ Venous or cardiac perforation.
6. CLINICAL STUDIES Clinical data presented in this section are from the MSP clinical study. PARADYM RF SonR CRT-D is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PARADYM RF SonR CRT-D. 6.1. MSP CLINICAL STUDY OVATIO CRT-D and earlier models were evaluated clinically in an international, multi-center, randomized clinical trial of Sorin CRM’s cardiac resynchronization therapy (CRT-D) system.
♦ Results IMPROVEMENT IN COMPOSITE ENDPOINT Patients were included in the analysis if complete (peak VO2 and quality of life) baseline and six-month data were available. Number of patients contributing to analysis Mean percent improvement in composite endpoint for control group Mean percent improvement in composite endpoint for CRT-D group Percent greater improvement for CRT-D group p-value 132 15.5 % 24.9 % 9.4 % 0.
Change in Peak VO2 (mL/min/Kg) Absolute difference between test and control groups’ change in peak V02 over 6 months Baseline Mean ± SD (range) 6-month Mean ± SD (range) Difference within group Control group (n=41) 13.39 ± 4.58 (5.02, 24.10) 13.12 ± 3.99 (3.30, 20.70) - 0.28 Test group (n=91) 11.84 ± 3.90 (3.50, 26.3) 13.41 ± 4.28 (6.18, 27.67) 1.57 Difference between groups 1.
The table below presents the percentage of patients in each group who improved, worsened, or remained unchanged in each element of the composite score and the composite score itself. QOL score VO2 Score Composite Score Control Test GROUP GROUP Control GROUP Test Control GROUP GROUP Test GROUP % Improved 75.6 74.7 48.8 67.0 62.2 70.9 % Worsened 24.4 25.3 51.2 31.9 37.8 28.6 % Unchanged 0.0 0.0 0.0 1.1 0.0 0.
RER at peak VO2 at six months Test Control 60 Percent of patients 50 40 30 20 10 0 ≤ 0.79 0.80-0.89 0.90-0.99 1.0-1.09 1.10-1.19 1.20-1.29 ≥ 1.30 RER ♦ Clinical Results V-V timing V-V programmable settings were available for the clinical study devices as follows: ALTO MSP model 617 (not programmable for V-V delay), ALTO 2 MSP model 627 values (0, 31, 39, 47, 55 and 63 ms) and OVATIO CRT-D 6750 values (0 to 63 ms in steps of 8 ms).
The optimization protocol in the clinical study specified that each patient randomized should undergo echo guided V-V optimization. Per the investigational plan for the MSP Clinical Trial, a uniform protocol was used for V-V programming. This protocol required all patients to undergo echo-guided V-V delay optimization before randomization (2 to 14 days post-implant).
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.
─ 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.
Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.105(b) - The FCC product ID is YSGCRTDSONR9770. 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. IC Requirements for canada - The IC product ID is 10270A-CRTDSON9770 This class B digital apparatus meets all requirements of the Canadian Interference- causing equipment regulations.
10. PHYSICIAN GUIDELINES 10.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator and left ventricular pacing lead implant procedures. They must apply these procedures according to professional medical training and experience. Physicians should be 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. Complete the Patient Registration Form and return it to Sorin CRM, as it provides necessary information for warranty purposes and patient tracking. Additional programming instructions can be found by accessing Online Help (click the “?” on the screen) on the Sorin CRM dedicated programmer.
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. 12. HOW SUPPLIED 12.1.
The PARADYM RF SonR CRT-D 9770 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. PARADYM RF SonR CRT-D 9770 features the PARAD/PARAD+ algorithm, which is specifically designed to differentiate ventricular tachycardias from fast rhythms of supraventricular origin.
When the rhythm changes from one zone to another, the device delivers the therapy programmed in this zone, starting with the same or more aggressive program for the area. The ATP program in the VF zone will only be applied if the VT coupling interval is longer than the programmed fast VT cycle length. The PARADYM RF SonR CRT-D 9770 offers biphasic shocks with a maximum stored energy of 42 J.; all automatic shocks are delivered in a non-committed way.
─ 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 five ports: ─ Atrial “sonR” port: performs atrial bipolar pace/sense if a conventional IS-1 lead is connected. ─ RV “IS-1” port: performs right ventricular bipolar pace/sense. ─ LV “IS-1” port: performs left ventricular bipolar pace. ─ RV “DF-1” ports for RV defibrillation coil.
─ physiological signal monitor capable of displaying simultaneously the surface ECG and arterial pressure, ─ an external defibrillator with sterile external paddles, ─ sterile cover for the telemetry head. 14.2. PACKAGING ♦ Contents The PARADYM RF SonR CRT-D 9770 and its accessories are ethylene oxide sterilized and hermetically sealed in two-ply clear packaging meeting international requirements.
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 CRM. 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.
CAUTION: Do not shake or tap sharply on the ICD package with the ICD inside, because the ICD's sensing circuits can interpret this as Pwaves or R-waves and record these as an arrhythmia episode. If unusual shaking or tapping of the package results in a stored arrhythmia episode, erase the recording before using the ICD. 14.6. DEVICE PLACEMENT The pocket should be prepared in the left pectoral position, either subcutaneously or submuscularly.
Connectors: The ventricular connectors are compatible with the IS-1 standard and the defibrillation connectors are compatible with the DF-1 standard (refer to the “Lead evaluation and lead connection” sub-section in the “Warnings and precautions” section). Shock configuration (+ -> -) The shock configuration is the energy pathway between the defibrillation electrodes. If an atrial coil is present, the shock configuration can be programmed for bi-directional shocks.
Pacing thresholds: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width, in both ventricles and in the atrium. Sensing thresholds: For proper right ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For proper atrial sensing, the amplitude of the P-wave should be greater than 2 mV.
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.
14.11. 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. Verify that the defibrillation lead impedance for each shock delivered ranges from 30 to 150 ohms. Check the lead connection if the values are outside these boundaries.
─ pacing rate is set to the magnet rate, ─ the following functions are disabled: ventricular arrhythmia prevention, Mode Switch, Anti-PMT, Smoothing, Rate Response. When the magnet is removed: ─ the sensor rate is forced to the basic rate, ─ arrhythmia detection algorithms and sequential therapies are reinitialized, ─ therapies start with the least aggressive program for each area. The other parameters remain at their programmed value, including the ventricular paced chamber parameter.
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.
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. 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.
Polarity alternation on Max shock: Reverses the programmed polarity of every second shock set at maximum energy. The number, type, and energy of shocks is independently programmable by detection zone. 16.4. PACING BTO (Brady Tachy Overlap): Enables cardiac resynchronization therapy within the slow VT zone to preserve patient exercise capacity, without affecting detection or treatments of slow VTs.
noise and ventricular fibrillation. If the device senses ventricular noise, the ventricular sensitivity is decreased until noise is no longer 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.
16.6. SONR CRT OPTIMISATION SonR is a specific sensor, located at the tip of the atrial lead, that picks-up micro-accelerations of the heart walls to derive information pertaining to cardiac contractility. The signal picked-up by the SonR sensor can be processed by PARADYM RF SonR CRT-D 9770 in order to automatically adjust VV delays and AV delays during rest and exercise for optimal resynchronization therapy.
16.7. FOLLOW-UP FUNCTION Storage of memory data: AIDA+ (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6 months of patient follow-up with day by day data collection, or up to 24 hours with hourly data collection. Episodes of ventricular tachyarrhythmia are recorded with the programmable EGM channels: either by selecting up to two traces, or by selecting "Double V" which enables a one-channel recording that is twice as long.
16.8. 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.
─ the on-demand follow-up transmission is triggered by the patient himself through the use of a specific button on the remote-monitor.
Data transmitted The data transmitted are identical to the data available during a standard interrogation with the Orchestra Plus programmer.
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) ─ Abnormal coil impedance (shock lead) ─ Low or High shock impedance ─ Long charge time ─ Inefficient high energy shock ─ All shocks programmed OFF ─ Shock treated VT/VF ─ Lack of V pacing in CRT device ─ Suspicion of noise on the V lead ─ AT/AF occurrence ─ Fa
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 SonR CRT-D 9770 stores up to 14 episodes (VF, VT, Slow VT, SVT/ST, non-sustained).
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 SonR CRT-D 9770 can still function for: ─ 7.
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. SUPPLEMENTAL INFORMATION Clinical data presented in this section are from the SafeR clinical study. SafeR operation in PARADYM RF is similar to that in the Symphony pacemaker. The data provided are applicable to PARADYM RF SonR CRT-D 9770.
18.1. ADVERSE EVENTS IN THE 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.
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 0 related events outside the use of SafeR 0 0 0 Non-serious pacemaker related events outside the use of SafeR 0 0 0 0 Serious events due to 0 the use of SafeR 0 0 0 Non-serious events 13 related due to the use SafeR 28.9 15 3.2 Serious nonpacemaker related events 6 13.
Non-serious events due to the use of SafeR 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.
18.2. SAFER CLINICAL STUDY SafeR mode in PARADYM RF is similar to that in Symphony. The differences in SafeR mode between the two devices are: ─ To prevent long RR intervals during VT/VF, SafeR has no effect during VT/VF therapy, electrophysiologic studies, and post-shock recovery. ─ The maximum acceptable AV delay for first degree AV block varies as a function of pacing rate. ─ PARADYM RF requires a ventricular sensed event to atrial paced event (RA) interval of at least 100 ms.
(69 %) were male. Mean patient age (± SD) was 74 ± 9 years. Primary indications for implant were: 1st degree AV block (11.1 %), 2nd degree AV block (6.7 %), 3rd degree AV block (22.2 %), sinus node dysfunction (62.2 %) or other (6.7 %). Effectiveness results: To determine the effectiveness of SafeR mode, the percentage of ventricular pacing provided over one month was recorded from pacemaker memory. Thirty-five patients contributed data to evaluate the percentage of ventricular pacing provided with SafeR.
84 % of patients without AV block at implant. 63 % of patients with 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.
19. 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: SonR. Right ventricle: IS-1, DF-1. Left ventricle: IS-1. 19.1. 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.
20. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C.
20.1. 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.
20.2. 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. 20.3. LONGEVITY The longevities mentioned below are calculated by taking into account 6 months storage. 5.1 years Biventricular pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF 4.
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.
21. PROGRAMMABLE PARAMETERS measured at 37 °C under a 500 ohm load Legend: Value in bold: “as shipped” value Underlined value: nominal value 21.1.
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 Physical activity Very low-Low-Medium-High-Very high CRT optimisation OFF- AV+VV Exercise AV opt.
Pacing/Sensing Values Atrial sensitivity (mV) Atrial amplitude (V) (1) (2) From 0.2 to 4 by steps of 0.2; 0.4 (± 50 %) 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 %) RV amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) LV amplitude (V) (2) 0.25 (± 50 %) 0.5-0.75- (± 30 %) 1-1.25-1.5-1.
Programmed ampl. (V) Mid-pulse delivered ampl. (V) Stored amplitude (V) Programmed ampl. (V) Mid-pulse delivered ampl. (V) Stored amplitude (V) 3.25* 3.05 3.58 4.75* 4.36 5.12 3.5 3.25 3.82 5 4.47 5.25 3.75* 3.39 3.98 6 5.37 6.30 4 3.58 4.20 7* 6.26 7.35 4.25* 4.5 3.88 4.23 4.55 4.96 * For left ventricular amplitude only.
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 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) AVD Paced/Sensed Offset (ms) 0-10-15-25-30-40-45-55-65-70-80-85-95100-110-115-125 (± 1
Refractory periods Values Atrial refractory period post ventricular 45-65-80-95-110-125-140-155 sensing (ms) (± 16 ms) Atrial refractory period post ventricular 80-95-110-125-140-155 (± 4 ms) pacing (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) Response to noise From 0 to 2 by steps of 0.2; 0.
21.2.
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
21.3.
♦ 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.
21.4. REMOTE ALERTS AND 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 followup, the information is managed as a warning (pop-up message) to notify immediately the user.
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 RV lead impedance ON-OFF Abnormal RV lead low limit (Ohm) 200-250-300-350-400-450-500 Abnormal RV lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal LV lead impedance ON-OFF Abnormal LV lead low limit (Ohm) 200-250-300-350-400-450-500 Abnormal LV lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal RV co
Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shockInefficient max shock US-ENGLISH – 87
22.
23. 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.
23.1. ARTICLE 1: TERMS OF LIMITED WARRANTY 1. The PARADYM RF implantable cardioverter defibrillator is only guaranteed for the first implantation. 2. The EURID/IAPM implant form must be sent to Sorin CRM within 30 days after implantation. 3. The PARADYM RF cardioverter defibrillator must be implanted prior to the use-before date indicated on the packaging. 4.
7. The replacement terms or conditions described in article 2 include all devices that shall be replaced within the limited warranty period because of battery depletion, without any 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 PARADYM RF device is distributed will supersede any warranty conditions indicated in this manual that conflict with such laws.
23.2. 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.
24.
25. EXPLANATION OF SYMBOLS The symbols on product labelling have the following meaning: Use by Date of Manufacturer Manufacturer Serial number Batch number For single use only. Sterilised using ethylene oxide Temperature limitation High voltage Consult instruction for use.