PLATINIUM 4LV CRT-D 1744 IMP L A N T M A N U A L Implantable cardioverter defibrillator with cardiac resynchronization therapy 4 LV CRT-D models
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SORIN PLATINIUM 4LV CRT-D Reminder Battery depletion voltage RRT BOS 10 kOhm > 3.2 V 2.62 V years Leads connection - 1744 model RA, IS-1 BI RA, IS-1 BI 2.66 V > 3.
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TABLE OF CONTENTS 1. GENERAL DESCRIPTION ........................................................................................ 8 2. INDICATIONS ............................................................................................................ 9 3. CONTRAINDICATIONS........................................................................................... 10 4. WARNINGS AND PRECAUTIONS.......................................................................... 11 4.1.
14.8. Shock configuration (+ -> -)...................................................................................... 35 14.9. Measurement of thresholds at implant ..................................................................... 36 14.10. Leads connection ..................................................................................................... 36 14.11. Device implantation .................................................................................................. 37 14.12.
22. NON PROGRAMMABLE PARAMETERS............................................................... 69 23. LIMITED WARRANTY ............................................................................................. 70 24. PATENTS ................................................................................................................. 71 25. EXPLANATION OF SYMBOLS ...............................................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION PLATINIUM 4LV CRT-D 1744 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. PLATINIUM 4LV CRT-D 1744 is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity.
2. INDICATIONS 2. INDICATIONS PLATINIUM 4LV CRT-D 1744 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of PLATINIUM 4LV CRT-D 1744 is contraindicated in patients: ― whose ventricular tachyarrhythmias may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes, ― who present incessant tachyarrhythmia, ― who have an internal pacemaker, ― whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
4. WARNINGS AND PRECAUTIONS 4. WARNINGS AND PRECAUTIONS The patient should be warned of the potential risks of defibrillator malfunction if he is exposed to external magnetic, electrical, or electromagnetic signals. These potential interference sources may cause conversion to inhibited mode (because of noise detection), erratic delivery of VT or VF therapies, nominal programming, or much more rarely, irreversible damage to the device’s circuits.
4. WARNINGS AND PRECAUTIONS Cellular phones: Radiofrequency signals can interfere with the functioning of the device if the handset is placed too close to the pacemaker. It is advisable to maintain a minimum distance of 15 cm (6 inches) between the cellular telephone and the implanted device, when the telephone is turned on.
4. WARNINGS AND PRECAUTIONS Radiation therapy: Avoid exposure to ionizing radiation. Betatrons are contraindicated. If high doses of radiation therapy cannot be avoided, the defibrillator should be protected from direct exposure with a protection shield. ATP and shock therapies should be disabled during exposure and proper device function should be checked regularly afterwards. Resulting damage may not be immediately detectable.
4. WARNINGS AND PRECAUTIONS Program device parameters such as sensitivity threshold and VT and VF detection intervals as specified in the device manuals. 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. WARNINGS AND PRECAUTIONS The defibrillator can undergo a short-circuit if the anode and cathode are not adequately separated.In this case, the shock is aborted and a warning will indicate that a short circuit (shock impedance < 20 ohms) was detected during the last shock. The device may be damaged compromising ability to provide shock therapy. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the MSP clinical study. PLATINIUM 4LV CRTD 1744is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PLATINIUM 4LV CRT-D 1744. 5.1. MSP STUDY Sorin conducted an international, multi-center, randomized clinical trial of its cardiac resynchronization therapy system. Investigators attempted to implant study devices in 190 patients.
5. ADVERSE EVENTS 5.2. Event # of Patients % of Patients # of Events Events/100 DeviceYears Worsening CHF/CHF decompensation 13 6.8 16 0.8 Atrial fibrillation/flutter 7 3.7 8 0.4 Ventricular tachycardia 7 3.7 7 0.
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the MSP clinical study. PLATINIUM 4LV CRTD 1744 is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PLATINIUM 4LV CRT-D 1744. 6.1. MSP CLINICAL STUDY OVATIO CRT-D and earlier models were evaluated clinically in an international, multi-center, randomized clinical trial of Sorin’s cardiac resynchronization therapy (CRT-D) system.
6. CLINICAL STUDIES 6.1.4. Absolute Differences in Peak VO2 and QOL The tables below show the absolute differences between the control and test groups’ peak VO2 and QOL over the 6 month follow-up period in the clinical trial. Absolute difference between test and control groups’ change in peak V0 2 over 6 months Change in Peak VO2 (mL/min/Kg) Baseline Mean ± SD (range) 6-month Mean ± SD (range) Difference within group Difference between groups Control group (n=41) 13.39 ± 4.58 (5.02, 24.10) 13.
6. CLINICAL STUDIES 6.1.5. 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 graph below shows the programmed V-V settings at randomization by percentage of patients programmed to each combination of Synchronous BiV pacing and V-V delay.
6. CLINICAL STUDIES 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 postimplant). The optimal V-V delay was determined by finding the programmable V-V delay and ventricular chamber pacing order (RV then LV, or LV then RV) providing the maximum time velocity integral (TVI or VTI) across the left ventricular outflow tract (LVOT).
7. PATIENT SELECTION AND TREATMENT 7. PATIENT SELECTION AND TREATMENT 7.1. INDIVIDUALIZATION OF TREATMENT Exercise stress testing: If the patient’s condition permits, use exercise stress testing to: ― Determine the maximum rate of the patient’s normal rhythm, ― Identify any supraventricular tachyarrhythmias, ― Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.
7. PATIENT SELECTION AND TREATMENT Nursing Mothers: Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk. Pediatric Patients: This device has not been studied in patients younger than 18 years of age. Geriatric Patients: Most of the patients receiving this device in clinical studies were over the age of 60 years.
8. PATIENT COUNSELLING INFORMATION 8. PATIENT COUNSELLING INFORMATION The physician should consider the following points in counselling the patient about this device: ― Persons administering CPR may experience tingling on the patient’s body surface when the patient’s ICD system delivers a shock. ― Advise patients to carry Sorin ID cards and/or ID bracelets documenting their ICD system.
9. DECLARATION OF CONFORMITY 9. DECLARATION OF CONFORMITY Sorin declares that this device is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutual recognition of their conformity (R&TTE). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.
9. DECLARATION OF CONFORMITY this device must accept any interference, including interference that may cause undesired operation of the device. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.
10. PHYSICIAN GUIDELINES 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. PHYSICIAN GUIDELINES ― Its storage package has been pierced or altered, because this could have rendered it non-sterile. ― 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 by" date has expired, because this can adversely affect pulse generator longevity or sterility.
11. PATIENT INFORMATION 11. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in the outer storage package. Additional copies can be obtained by contacting your Sorin representative. This information should be given to each patient with their first ICD and offered to the patient on each return visit or as deemed appropriate.
12. HOW SUPPLIED 12. HOW SUPPLIED 12.1. STERILITY The PLATINIUM defibrillators are supplied one per package in a sterile package. 12.2. WARRANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators. Refer to the section "Warranty" for additional information. Please see the following labelling sections for information concerning the performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The PLATINIUM 4LV CRT-D 1744 ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The PLATINIUM 4LV CRT-D 1744 can serve as a defibrillation electrode (active housing) with a total surface area of 62.4 cm².
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14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE 14.4. BEFORE OPENING THE PACKAGE Before opening the package, check the "Use by" date printed on the labels on the box and on the sterile package. Defibrillators that have not been implanted by the end of the “Use by” date should be returned to Sorin. Interrogate the device: ― if a warning is displayed, do not implant the device and contact your Sorin representative.
14. IMPLANT PROCEDURE ― one DF4 right ventricular lead with bipolar sensing/pacing electrodes and one or two defibrillation coils (DF4-LLHO or DF4-LLHH) ― one IS4-LLLL left ventricular pacing lead The choice of leads and their configuration is left to the implanting physician’s judgment. NOTE1: Please note that in the event of defibrillator replacement, DF-1 standard compliant lead is not compatible with DF4 connector and DF4 standard compliant lead is not compatible with DF-1 connector.
14. IMPLANT PROCEDURE 14.9. 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 0.35 ms pulse width, in both ventricles and in the atrium. Sensing thresholds: For appropriate right ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For appropriate atrial sensing, the amplitude of the P-wave should be greater than 2 mV.
14. IMPLANT PROCEDURE As a matter of fact, when the lead port is filled with a liquid, the physics piston effect can give the feeling the lead is properly tightened. 4. One single set screw is located on the side of the connection header. 5. Use only the screwdriver provided with the defibrillator. Keep the screwdriver's shaft perpendicular to the plane of the defibrillator (see figure below). 6.
14. IMPLANT PROCEDURE 14.12. TESTS AND PROGRAMMING During the implant testing procedure: It is recommended that a safety 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 shock impedance for each shock delivered is within the range of 30 to 150 ohms. Check the lead connection if the values are outside these boundaries.
15. SPECIAL MODES 15. SPECIAL MODES 15.1. SAFETY MODE (NOMINAL VALUES) Nominal values may be rapidly restored by pressing the following button on the programming head or programmer keyboard: or via the Emergency button on the SMARTVIEW screen. In safety mode, the defibrillator operates with the nominal parameters values in the table of programmable parameters. 15.2.
15. SPECIAL MODES ― Common mode rejection ratio: 16.6 Hz 50 Hz 60 Hz Atrial channel ≥74 dB ≥74 dB ≥74 dB Ventricular channel ≥68 dB ≥68 dB ≥68 dB For atrial sensitivity settings below 0.4mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz. For ventricular sensitivity settings below 0.6mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on atrial and ventricular leads every 6 hours. The daily mean impedance is stored for each chamber. Automatic coil impedance measurement: A coil impedance measurement is automatically performed on defibrillation coil(s) once per day. The coil impedance is stored for each coil.
16. MAIN FUNCTIONS Defibrillation threshold (DFT): Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in non-conversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively. 16.4.
16. MAIN FUNCTIONS 16.6. LV MULTIPOINT PACING (MP) PLATINIUM 4LV CRT-D 1744 features simultaneous multipoint left ventricular pacing allowing LV pacing on 2 differents vectors at the same time, named MP1 and MP2 LV pacing sites. 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.
16. MAIN FUNCTIONS ― the alert transmission will take place when the implant has recorded an abnormal events. The list of abnormal event is available in a following paragraph. Alert conditions are checked daily. ― the on-demand follow-up transmission is triggered by the patient himself through the use of a specific button on the SMARTVIEW monitor. 16.8.3. Data transmitted The data transmitted are identical to the data available during a standard interrogation with the dedicated programmer.
16. MAIN FUNCTIONS The following set of alert triggers (system alerts) cannot be deactivated when the Alerts are programmed “On” and can trigger an alert transmission: ― Battery depletion – RRT ― Device reset ― Excessive charge time (>25s) ― System integrity WARNING: The use of remote monitoring does not replace regular follow-up. Therefore, when using remote monitoring, the time period between follow-ups visits may not be extended.
17. PATIENT FOLLOW-UP 17. PATIENT FOLLOW-UP 17.1. FOLLOW-UP RECOMMENDATIONS Before the patient is discharged and at each subsequent follow-up visit, it is advisable to: ― check the occurrence of system warnings ― check the battery status, NOTES: If the last reforming, charge or shock occurred during the week preceding the interrogation, the last battery value may be still impacted by the event. One week post event, the battery will recover its steady state value.
17. PATIENT FOLLOW-UP Stored Tachyarrythmia Episodes: PLATINIUM 4LV CRT-D 1744 stores up to 16 episodes (VF, VT, Slow VT, SVT/ST, nonsustained) with a total of 25.6 min of high resolution EGM.
17. PATIENT FOLLOW-UP ― The Recommended Replacement Time (RRT) 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.
18. SUPPLEMENTAL INFORMATION 18. SUPPLEMENTAL INFORMATION Clinical data presented in this section are from the SafeR (AAI <> DDD) clinical study. SafeR (AAI <> DDD) operation in PLATINIUM is similar to that in the Symphony pacemaker. The data provided are applicable to PLATINIUM 4LV CRT-D 1744. 18.1. ADVERSE EVENTS IN THE SAFER (AAI <> DDD) STUDY Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in 45 patients. No serious adverse events were device- or feature-related.
18. SUPPLEMENTAL INFORMATION ― 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 PLATINIUM because the principles of SafeR (AAI <> DDD) 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.
18. SUPPLEMENTAL INFORMATION ― 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 (AAI <> DDD) provides in an individual will depend on the amount of time that the patient spends in AV block.
19. PHYSICAL CHARACTERISTICS 19. PHYSICAL CHARACTERISTICS 19.1. Dimensions 78.1 x 54.3 x 11.1 mm Weight 91 g Volume 33.7 cm3 Active surface area of casing 62.4cm2 Connector Atrium: IS-1 (bipolar). Right ventricle: DF4. Left ventricle: IS4. MATERIALS USED Active surface area of casing 99% pure titanium Connectors Polyurethane* and silicone elastomer* *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications.
20. ELECTRICAL CHARACTERISTICS 20. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 149 µF ± 8 % Capacitor reformation No reformation required Rate limit 192 ppm ± 10 ppm Pacing waveform Defibrillation waveform 20.1.
20. ELECTRICAL CHARACTERISTICS Voltage 20.3. BOS: 3.24 V. RRT: 2.62 V. EOS: 2.5 V. LONGEVITY The longevities are calculated by taking into account 6 months storage with the following conditions: ― Mode: DDD ― Basic rate: 60 ppm ― Pulse width (A, RV, LV): 0.
20. ELECTRICAL CHARACTERISTICS If Multipoint LV Pacing (MP) is set to ON, an additional LV pacing vector is activated. Consequently, the device longevity is reduced from 0.8 to 1.6 year dependent on the device operating under the conditions described in the tables above, with MP activated for the entire lifetime of the device from implant to explant, with the same LV pacing parameters (LV amplitude, LV pulse width) and impedance applied on both LV vectors (MP1 and MP2).
21. PROGRAMMABLE PARAMETERS 21. PROGRAMMABLE PARAMETERS Measured at 37 °C under a 500 ohm load. 21.1.
21. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Nominal value "As shipped" value Atrial sensitivity (mV) From 0.2 to 4 by steps of 0.2 (± 50 %) 0.4 0.4 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5 Atrial pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) 0.35 0.35 Ventricular sensitivity (mV) (1) From 0.4 to 4 by steps of 0.2 (± 50 %) 0.4 0.4 RV amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5 RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) 0.
21. PROGRAMMABLE PARAMETERS Programmed amplitude (V) Stored amplitude (V) Mid-pulse delivered amplitude (V) Programmed amplitude (V) Stored amplitude (V) Mid-pulse delivered amplitude (V) 2.10* 2.21 1.87 4.60* 4.82 4.08 2.25* 2.34 1.98 4.75* 4.95 4.19 2.35* 2.47 2.09 4.85* 5.08 4.30 2.50 2.60 2.20 5.00 5.25 4.44 2.60* 2.73 2.31 5.10* 5.34 4.52 2.75* 2.87 2.42 5.25* 5.47 4.63 2.85* 3.00 2.53 5.35* 5.60 4.74 3.00 3.15 2.67 5.50* 5.73 4.85 3.10* 3.26 2.
21. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Nominal value "As shipped" value LV amplitude – MP1 (V) (1) 0.1-0.25-0.35 (± 80 %) 5 3.5 0.5-0.6-0.75-0.85 (± 30 %) 1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.12.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.253.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.354.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.55.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.66.75-6.85-7- (± 20 %) LV pulse width – MP1 (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.11.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %) 0.35 0.
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21. PROGRAMMABLE PARAMETERS Post-shock mode Values Nominal value "As shipped" value LV amplitude – MP1 (V) 0.1-0.25-0.35 (± 80 %) 5 3.5 0.5-0.6-0.75-0.85 (± 30 %) 1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.12.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.253.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.354.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.55.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.66.75-6.85-7 (± 20 %) LV pulse width – MP1 (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.11.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %) 0.35 0.
21. PROGRAMMABLE PARAMETERS 21.2.
21. PROGRAMMABLE PARAMETERS 21.3.
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21. PROGRAMMABLE PARAMETERS 21.3.2.
21. PROGRAMMABLE PARAMETERS Shock program Values Nominal value "As shipped" value Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-67-8-9 OFF OFF OFF OFF 4 4 10-12-14-16-18-20-22-24-26-28-30-3234-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-67-8-9 10-12-14-16-18-20-22-24-26-28-30-3234-42 Number of Max. Shock (42 J) OFF-1-2-3-4 21.3.3.
21. PROGRAMMABLE PARAMETERS up, the information is managed by a warning (pop-up message) to immediately notify the user. For example, the following types of events can trigger a warning or an alert: technical problem during a shock, pacing lead impedance or coil impedance measurements out-ofrange, battery depletion, etc. The Remote tab presents an overview of all the alerts managed by the device.
21. PROGRAMMABLE PARAMETERS 68 Clinical status Values Nominal value "As shipped" value V oversensing ON-OFF OFF OFF High AT/AF burden ON-OFF OFF OFF AT/AF limit (on 24h) (h) 0.5-1-3-6-12-24 6 6 Fast V Rate during AT/AF ON-OFF OFF OFF Fast V Rate limit (ppm) 80-90-100-110-120 100 100 Fast V Duration limit (h) 0.
22. NON PROGRAMMABLE PARAMETERS 22. NON PROGRAMMABLE PARAMETERS Interval Values Committed period 95 ms (± 5 ms) Atrial refractory periods Values Post atrial sensing 47 ms (± 16 ms) Post atrial pacing 109 ms (± 4 ms) Ventricular refractory periods Values Post ventricular sensing 95 ms (± 16 ms) Post ventricular pacing 220 ms (± 4 ms) Post atrial pacing (blanking) 16 ms (± 3 ms) Therapies Values Waveform (1) Constant tilt (50% - 50%) Stored energy for the Max.
23. LIMITED WARRANTY 23. LIMITED WARRANTY The PLATINIUM implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. The terms of the limited warranty are available upon request from your Sorin representative.
24. PATENTS 24.
25. EXPLANATION OF SYMBOLS 25. EXPLANATION OF SYMBOLS List of applicable symbols for High-voltage Sorin devices. General symbols Explanation of symbols General symbols Use by Explanation of symbols Screwdriver Mode Date of manufacture Basic rate Manufacturer Catalogue number Consult instructions for use Serial number Instructions for use in the CD-ROM Implantable device uncoated This icon is used to call your attention to a particularly important point.
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CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN manufactured in italy by Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 Fax: +39 0161 487524 distributed by Sorin CRM USA, Inc. 14401 West 65th Way Arvada, CO 80004 USA Tel: 877.663.7674 w w w. livanova .
