SORIN CRM CRTDSOR1844 Implantable Cardioverter defibrillator with RF wireless communication availability User Manual Sorin CRM

SORIN CRM Implantable Cardioverter defibrillator with RF wireless communication availability Sorin CRM

User Manual.pdf

PLATINIUM 4LV SonR CRT-D 1844IMPLANT MANUALImplantable cardioverter debrillator with cardiacresynchronization therapy SonR 4LV CRT-D models– –
10 kOhmL V , IS4-LLLLRV, DF4 - LLHH RV, DF4 - LLHHRA, IS-1 BI / SonRRA, IS-1 BI / SonRRA,SO NRL V , IS4-LLLLR V ,DF4 -LLHHSORIN PLATINIUM 4LV SonR CRT-D2.66 V> 3.2 VLeads connection - 1844 model2.66 V> 3.2 VBattery depletionReminder2.62 V> 3.2 VvoltageyearsRRTBOSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
TABLE OF CONTENTS1. GENERAL DESCRIPTION ........................................................................................ 82. INDICATIONS ............................................................................................................ 93. CONTRAINDICATIONS........................................................................................... 104. WARNINGS AND PRECAUTIONS.......................................................................... 11Risks related to medical environment ...................................................................... 12Sterilization, storage and handling ........................................................................... 13Implantation and device programming ..................................................................... 13Lead evaluation and lead connection....................................................................... 14Generator explant and disposal ............................................................................... 155. ADVERSE EVENTS................................................................................................. 16MSP study ................................................................................................................ 16Potential adverse events .......................................................................................... 176. CLINICAL STUDIES ................................................................................................ 18MSP clinical study .................................................................................................... 187. PATIENT SELECTION AND TREATMENT ............................................................. 22Individualization of treatment.................................................................................... 22Specific patient populations...................................................................................... 228. PATIENT COUNSELLING INFORMATION ............................................................. 249. DECLARATION OF CONFORMITY ........................................................................ 2510. PHYSICIAN GUIDELINES....................................................................................... 27Physician training ..................................................................................................... 27Directions for use ..................................................................................................... 27Maintaining device quality ........................................................................................ 27V-V Programming Recommendation........................................................................ 2811. PATIENT INFORMATION ........................................................................................ 2912. HOW SUPPLIED...................................................................................................... 30Sterility...................................................................................................................... 30Warranty and replacement policy............................................................................. 3013. DEVICE DESCRIPTION .......................................................................................... 3114. IMPLANT PROCEDURE ......................................................................................... 33Necessary equipment............................................................................................... 33Packaging................................................................................................................. 33Optional equipment .................................................................................................. 33Before opening the package .................................................................................... 34Prior to implantation ................................................................................................. 34Device placement..................................................................................................... 344.1.4.2.4.3.4.4.4.5.5.1.5.2.6.1.7.1.7.2.10.1.10.2.10.3.10.4.12.1.12.2.14.1.14.2.14.3.14.4.14.5.14.6.SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 5
Choosing the type of lead......................................................................................... 34Shock configuration (+ -> -)...................................................................................... 35Measurement of thresholds at implant ..................................................................... 36Leads connection ..................................................................................................... 36Device implantation .................................................................................................. 38Tests and programming............................................................................................ 3815. SPECIAL MODES.................................................................................................... 39Safety mode (nominal values).................................................................................. 39Magnet mode ........................................................................................................... 39Response in the presence of disturbance ................................................................ 39Detection characteristics in the presence of electromagnetic fields......................... 39Protection against short-circuits ............................................................................... 4016. MAIN FUNCTIONS .................................................................................................. 41Automatic lead measurements................................................................................. 41Atrial tachyarrhythmia management......................................................................... 41Ventricular tachyarrhythmia management................................................................ 41Pacing ...................................................................................................................... 42Sensing .................................................................................................................... 42SonR CRT optimization............................................................................................ 43LV Multipoint Pacing (MP) ........................................................................................ 43Follow-up function .................................................................................................... 43Remote Monitoring function ..................................................................................... 4317. PATIENT FOLLOW-UP............................................................................................ 46Follow-up recommendations .................................................................................... 46Holter Function ......................................................................................................... 46Recommended Replacement Time (RRT) ............................................................... 47Explantation.............................................................................................................. 47Defibrillator identification .......................................................................................... 4818. SUPPLEMENTAL INFORMATION .......................................................................... 49Adverse events in the SafeR (AAI <> DDD) study ................................................... 49SafeR (AAI <> DDD) clinical study........................................................................... 4919. PHYSICAL CHARACTERISTICS............................................................................ 52Materials used .......................................................................................................... 5220. ELECTRICAL CHARACTERISTICS ....................................................................... 53Table of delivered shock energy and voltage ........................................................... 53Battery ...................................................................................................................... 53Longevity .................................................................................................................. 5421. PROGRAMMABLE PARAMETERS........................................................................ 56Antibradycardia pacing............................................................................................. 56Ventricular tachyarrhythmia detection ...................................................................... 6214.7.14.8.14.9.14.10.14.11.14.12.15.1.15.2.15.3.15.4.15.5.16.1.16.2.16.3.16.4.16.5.16.6.16.7.16.8.16.9.17.1.17.2.17.3.17.4.17.5.18.1.18.2.19.1.20.1.20.2.20.3.21.1.21.2.6 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Ventricular tachyarrhythmia therapies ...................................................................... 63Remote alerts and warnings..................................................................................... 6622. NON PROGRAMMABLE PARAMETERS............................................................... 6923. LIMITED WARRANTY ............................................................................................. 7024. PATENTS ................................................................................................................. 7125. EXPLANATION OF SYMBOLS ............................................................................... 7221.3.21.4.SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 7
1. GENERAL DESCRIPTIONPLATINIUM 4LV SonR CRT-D 1844 is an implantable cardioverter defibrillator for therecognition and treatment of ventricular tachycardia and fibrillation, with ventricularresynchronization, in patients with spontaneous or inducible tachyarrhythmias.PLATINIUM 4LV SonR CRT-D 1844 is equipped with an accelerometer to allow adaptation ofpacing to suit the patient’s activity.PLATINIUM 4LV SonR CRT-D 1844 is also equipped with the RF wireless technology whichenables:― Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed athome,― wireless interrogation and device programming by Orchestra Plus programmer equippedwith ORCHESTRA PLUS LINK accessory.If used in conjunction with a dedicated atrial lead featuring the SonR sensor, PLATINIUM 4LVSonR CRT-D 1844 can analyze micro-accelerations of the heart walls to derive informationpertaining to cardiac contractility. The signal picked-up by the SonR sensor can be processedby PLATINIUM 4LV SonR CRT-D 1844 in order to automatically adjust AV and VV delays foroptimal resynchronization therapy.PLATINIUM 4LV SonR CRT-D 1844 features simultaneous multipoint left ventricular pacingallowing LV pacing on 2 differents vectors at the same time.PLATINIUM 4LV SonR CRT-D 1844 provides high energy shocks (42 J) for enhanced safety,as well as automatic lead measurements to monitor system integrity.Device and lead connections:1*IS4, 1*DF4, 1*SonR (IS-1 bipolar compatible)1. GENERAL DESCRIPTION8 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
2. INDICATIONSPLATINIUM 4LV SonR CRT-D 1844 is indicated for ventricular antitachycardia pacing andventricular defibrillation for automated treatment of life threatening arrhythmias.The device is also indicated for the reduction of heart failure symptoms in medically optimizedNYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less,and a QRS duration of 150 ms or longer.2. INDICATIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 9
3. CONTRAINDICATIONSImplantation of PLATINIUM 4LV SonR CRT-D 1844 is contraindicated in patients:― whose ventricular tachyarrhythmias may have transient or reversible causes such as:acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyteimbalance, hypoxia, sepsis, or unstable ischemic episodes,― who present incessant tachyarrhythmia,― who have an internal pacemaker,― whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.The use of the dual-chamber pacing mode is contraindicated in patients with chronicrefractory atrial tachyarrhythmias.3. CONTRAINDICATIONS10 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
4. WARNINGS AND PRECAUTIONSThe patient should be warned of the potential risks of defibrillator malfunction if he is exposedto external magnetic, electrical, or electromagnetic signals.These potential interference sources may cause conversion to inhibited mode (because ofnoise detection), erratic delivery of VT or VF therapies, nominal programming, or much morerarely, irreversible damage to the device’s circuits.The main sources of high magnitude disturbance are: powerful radiofrequency equipment(radar), industrial motors and transformers, induction furnaces, resistance welding/ arc-welding equipment and high power loudspeakers.Electrical Isolation:Do not permit the patient to contact grounded equipment that could produce hazardousleakage current. Ensuing arrhythmia induction could result in the patient’s death.Electronic Article Surveillance (EAS) and RadioFrequency IDentificationequipment (RFID)Patients should be advised to walk directly through and not lean against or linger nearElectronic Article Surveillance (EAS) systems such as retail theft prevention systems,security gates, entry control systems, or tag readers including Radio FrequencyIDentification equipment (RFID). These systems may be found at the entrances and exits ofstores, libraries, banks, etc...and may interact with pulse generators. It is unlikely that thesesystems affect cardiac function when the patient walks through them at a normal pace. Ifpatients do experience symptoms near these systems, they should promptly move away andinform their doctor.Work environment:The patient's work environment may be an important source of disturbance. In that case,specific recommendations may be required.High voltage power transmission lines:High voltage power transmission lines may generate enough disturbance to interfere withdefibrillator operation if approached too closely.Communication equipment:Communication equipment such as microwave transmitters, linear power amplifiers, or high-power amateur transmitters may generate enough disturbance to interfere with defibrillatoroperation if approached too closely.Home appliances:Home appliances that are in good working order and properly grounded do not usuallyproduce enough disturbance to interfere with defibrillator operation. However, there arereports of device interferences caused by electric hand tools or electric razors used directlyover the device implant site. Patient should also avoid using induction ovens and cookers.4. WARNINGS AND PRECAUTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 11
Cellular phones:Radiofrequency signals can interfere with the functioning of the device if the handset isplaced 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 isturned on.CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensingcircuits can detect this as P-waves or R-waves, and such oversensing could result ininappropriate pacing, inhibition, or therapy. Normal activities after implant do not result insuch oversensing.RISKS RELATED TO MEDICAL ENVIRONMENTIt is advisable to carefully monitor defibrillator operation prior to and after any medicaltreatment during which an electrical current from an external source passes through thepatient's body.Magnetic Resonance Imaging:MRI is contraindicated.Radiofrequency ablation:A radiofrequency ablation procedure in a patient with a generator may cause devicemalfunction or damage. RF ablation risks may be minimized by:1. Deactivating ATP and shock therapies.2. Avoiding direct contact between the ablation catheter and the implanted lead or generator.3. Positioning the ground, placing it so that the current pathway does not pass through ornear the device, i.e. place the ground plate under the patient’s buttocks or legs.4. Having external defibrillation equipment available.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 aspossible (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 cardiacdefibrillator. Set it at minimum intensity. Use it briefly.4. After the procedure, check for proper implant function. The device should never beexposed directly to the diathermy source.External defibrillation:PLATINIUM 4LV SonR CRT-D 1844 is protected from external defibrillation shocks.1. Before external defibrillation, deactivate ATP and shock therapies.2. During external defibrillation, it is advisable to avoid placing the defibrillating paddlesdirectly over the casing or over the leads. The defibrillating paddles should preferably beplaced in an anteroposterior position.3. Avoid any direct contact between the defibrillation paddles and the conductive parts of theimplanted leads or casing of the implanted device.4. After external defibrillation, check for proper device function.4.1.4. WARNINGS AND PRECAUTIONS12 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Radiation therapy:Avoid exposure to ionizing radiation. Betatrons are contraindicated. If high doses of radiationtherapy cannot be avoided, the defibrillator should be protected from direct exposure with aprotection shield. ATP and shock therapies should be disabled during exposure and properdevice function should be checked regularly afterwards. Resulting damage may not beimmediately detectable. If irradiation of tissues close to the implantation site is necessary, itis recommended that the cardiac defibrillator be moved. As a safety measure, an externaldefibrillator should be immediately available.Lithotripsy:Lithotripsy may permanently damage the device if it is at the focal point of the lithotripsybeam. If lithotripsy must be used, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) awayfrom the focal point of the lithotripsy beam.Diagnostic ultrasound (echography):The defibrillator is not affected by ultrasound imaging devices.Scales with body fat monitors and electronic muscle stimulators:A patient with an implanted PLATINIUM 4LV SonR CRT-D 1844 should not use thesedevices.STERILIZATION, STORAGE AND HANDLINGResterilization:Do not resterilize and re-implant explanted ICDs."Use by" Date:A "Use by" date is printed on the outer storage package and on the sterile package. Donot implant the device after this date because the battery may have reduced longevity andsterility may be affected. It should be returned to Sorin.If Package is damaged:Do not use the device or accessories if the packaging is wet, punctured, opened or damagedbecause the integrity of the sterile packaging may be compromised. Return the device to themanufacturer.Device Storage:Store the device in a clean area, away from magnets, kits containing magnets, and sourcesof electromagnetic disturbance to avoid device damage. Store the device between 0 - 50 °C(32 - 122 °F). Temperatures outside the specified range may damage the device.Equilibration:Allow the device to reach room temperature before programming or implanting the devicebecause rapid temperature changes may affect initial device function.IMPLANTATION AND DEVICE PROGRAMMINGUse only a Sorin programmer to communicate with the device.Do not inadvertently position any magnet over the ICD; this suspends tachyarrhythmiadetection and treatment.Replace the device when the RRT (Recommended Replacement Time*) point (defined by abattery voltage of 2.62 ± 0.01 V) is reached.4.2.4.3.4. WARNINGS AND PRECAUTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 13
Program device parameters such as sensitivity threshold and VT and VF detection intervalsas specified in the device manuals.Lead System:Do not use a lead system other than those with demonstrated compatibility becauseundersensing cardiac activity and failure to deliver necessary therapy may result.In situations where an ICD and a pacemaker are implanted in the same patient, interactiontesting should be completed. If the interaction between the ICD and the pacemaker cannot beresolved through repositioning of the leads or reprogramming of either the pacemaker or theICD, the pacemaker should not be implanted (or should be explanted if previously implanted).Failure to properly insert the torque screwdriver into the perforation at an angle perpendicularto the connector receptacle may result in damage to the sealing system and its self-sealingproperties.In the event of a warning on a low shock impedance, and after lead replacement orreconnection: it is recommended to check the system integrity (sensing and pacing thresholdsand the impedance of the shock electrodes)It is recommended that a safety margin of at least 10 J be demonstrated between the effectiveshock energy and maximum programmable energy. Carefully confirm that true ventricularfibrillation has been induced because the DFT for ventricular tachycardia or flutter may belower.The defibrillator should be implanted with the engraved side facing outwards in order tofacilitate telemetric communication with the programming head and to display theradiographic identification correctly.*: corresponds to ERI (Elective Replacement Indicator) previously used.LEAD EVALUATION AND LEAD CONNECTIONPLATINIUM 4LV SonR CRT-D 1844 has one DF4, one IS4, and one SonR connector ports.The SonR connector port has been specifically designed by Sorin to accept three connections(tripolar). The two distal connections respect the same dimensions as the IS-1 standard, andan additional proximal connection allows to collect the SonR signal.The SonR port accepts either a conventional atrial lead (without SonR capability) or a SonRatrial lead (bipolar pacing/sensing and SonR capability).IS-1 refers to the international standard whereby leads and generators from differentmanufacturers are assured a basic fit (ISO 5841-3:2013).DF4 and IS4 refer to the international standard for Four-pole connector systems forimplantable cardiac rhythm management devices (ISO 27186:2010).Use only DF4-LLHH or DF4-LLHO standard lead connector types according to ISO27186:2010.Use only IS4-LLLL standard lead connector type according to ISO 27186:2010.Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessivestrain at the insertion site as this may damage the lead. Use the lead stabilizer to secure thelead lateral to the venous entry site.Do not grip the lead with surgical instruments.Do not use excessive force or surgical instruments to insert a stylet into a lead.Use ventricular transvenous leads with caution in patients with either a mechanical orbioprosthetic tricuspid valvular prosthesis.4.4.4. WARNINGS AND PRECAUTIONS14 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Use the correct suture sleeve (when needed) for each lead, to immobilize the lead and protectit against damage from ligatures.The defibrillator can undergo a short-circuit if the anode and cathode are not adequatelyseparated.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 bedamaged compromising ability to provide shock therapy.Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resultingin lead fracture.Do not insert a lead connector pin into the connector block without first visually verifying thatthe setscrews are sufficiently retracted. Do not tighten the setscrews unless a lead connectorpin is inserted because it could damage the connector block.Lead electrodes in contact during a cardioversion or defibrillation therapy will cause currentto bypass the heart, possibly damaging the ICD and the leads. While the ICD is connected tothe 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 nota pathway for currents to or from the heart.If a thoracotomy is required to place epicardial patches, it should be done during a separateprocedure to reduce the risk of morbidity and mortality.Do not place the patch lead over nerve tissue as this may cause nerve damage.Place the patch lead with the conducting coil side facing the heart to ensure delivery of energyto the heart.Place the sutures well outside the coil of the patch lead or in the area between the coils toavoid possible coil fracture.If countershock is unsuccessful using external paddles, adjust the external paddle position(e.g., anterior-lateral to anterior-posterior) and be sure that the external paddle is notpositioned over the patch.Do not fold, alter, or remove any portion of the patch as it may compromise electrode functionor longevity.If a header port is unused on the generator, the port must be plugged to protect the generator.GENERATOR EXPLANT AND DISPOSALInterrogate the device, and program shock therapy off prior to explanting, cleaning or shippingthe device to prevent unwanted shocks.Return all explanted generators and leads to the manufacturer.Never incinerate the device due to the potential for explosion. The device must be explantedbefore cremation.4.5.4. WARNINGS AND PRECAUTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 15
5. ADVERSE EVENTSClinical data presented in this section are from the MSP clinical study.PLATINIUM 4LV SonR CRT-D 1844 is similar in design and function to the ALTO 2 MSP andOVATIO CRT-D devices. The data provided are applicable to PLATINIUM 4LV SonR CRT-D1844.MSP STUDYSorin conducted an international, multi-center, randomized clinical trial of its cardiacresynchronization therapy system. Investigators attempted to implant study devices in 190patients. A total of 182 patients received study devices and had an exposure of over 165device years. Of those patients, 19 received OVATIO CRT-D, 160 received ALTO 2 MSP, and3 received ALTO MSP. The clinical data collected on ALTO MSP, ALTO 2 MSP and OVATIOCRT-D are applicable to PLATINIUM 4LV SonR CRT-D 1844. The table below summarizesthe adverse events observed for the CRT-D system. No deaths were related to the system.Event # of Pa-tients% of Pa-tients# ofEventsEvents/100Device-YearsDeaths not related to the system 16 8.4 16 0.8Cardiac arrest 5 2.6 5 0.3Worsening CHF / CHF decompensa-tion3 1.6 3 0.2Multi-organ dysfunction 2 1.1 2 0.1Complications related to the sys-tem28 14.7 35 2.1Dislodgment or migration 9 4.7 11 0.6Extracardiac stimulation (e.g., phrenicstim)9 4.7 9 0.5Complications related to the im-plant procedure18 9.5 21 1.3Dislodgment or migration 4 2.1 4 0.2Observations related to the system 23 12.1 27 1.7Extracardiac stimulation (e.g., phrenicstim)12 7.9 15 0.8Observations related to the implantprocedure24 12.6 28 1.7Heart block 6 3.2 6 0.3Extracardiac stimulation (e.g., phrenicstim)3 1.5 5 0.3Serious adverse events not relatedto the system85 44.7 176 10.8Worsening CHF/CHF decompensation 24 12.6 42 2.1Atrial fibrillation/flutter 14 7.4 14 0.7Not Serious events not related tothe system58 30.5 121 7.45.1.5. ADVERSE EVENTS16 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Event # of Pa-tients% of Pa-tients# ofEventsEvents/100Device-YearsPain (in back, arms, chest, shoulder,groin, head, other)10 5.3 13 0.7Worsening CHF/CHF decompensation 13 6.8 16 0.8Atrial fibrillation/flutter 7 3.7 8 0.4Ventricular tachycardia 7 3.7 7 0.4POTENTIAL ADVERSE EVENTSAdverse events (in alphabetical order), including those reported in the previous tables,associated with ICD systems include:― Acceleration of arrhythmias (caused by device),― Air embolism,― Bleeding,― Chronic nerve damage,― Erosion,― Excessive fibrotic tissue growth,― Extrusion,― Fluid accumulation,― 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 externalpaddles,― Potential mortality due to inability to defibrillate or pace,― Thromboemboli,― Venous occlusion,― Venous or cardiac perforation.Patients susceptible to frequent shocks despite antiarrhythmic medical management maydevelop psychological intolerance to an ICD system that may include the following:― Dependency,― Depression,― Fear of premature battery depletion,― Fear of shocking while conscious,― Fear that shocking capability may be lost,― Imagined shocking (phantom shock).5.2.5. ADVERSE EVENTSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 17
6. CLINICAL STUDIESClinical data presented in this section are from the MSP clinical study. PLATINIUM 4LV SonRCRT-D 1844 is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices.The data provided are applicable to PLATINIUM 4LV SonR CRT-D 1844.MSP CLINICAL STUDYOVATIO 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.Investigators attempted to implant study devices in 190 patients. A total of 182 patientsreceived study devices and had an exposure of over 165 device years. Of those patients, 19received OVATIO CRT-D, 160 received ALTO 2 MSP, and 3 received ALTO MSP.ObjectivesThe primary objectives of the study were to demonstrate:― Greater improvement in a composite endpoint (percent improvement in peak VO2percent improvement in quality of life) for CRT-D patients than for control patients.― System complication-free rate ≥ 67 % at six months.MethodsPatients were New York Heart Association class III or IV and had one or more indications foran implantable cardioverter defibrillator (ICD). Patients performed cardiopulmonary exercisetesting at baseline and six-months after randomization. Patients were implanted with a SorinICD with CRT-D, a Situs UW28D left ventricular lead, and commercially available right atrialand ventricular leads. Routine follow-ups were at pre-discharge, randomization (3-14 dayspost-implant), one month, three months, and six months post randomization.ResultsImprovement in composite endpointPatients were included in the analysis if complete (peak VO2and quality of life) baseline andsix-month data were available.Number ofpatientscontributingto analysisMean percent im-provement in com-posite endpoint forcontrol groupMean percent im-provement in com-posite endpoint forCRT-D groupPercentgreater im-provementfor CRT-Dgroupp-value132 15.5 % 24.9 % 9.4 % 0.046Six-month system complication-free rateNumber of patientscontributing toanalysisKaplan-Meier six-monthcomplication-free esti-mateOne-sided lower 95% confidencebound for six-month complication-freeestimate190 89.5 % 84.1 %6.1.6.1.1.6.1.2.6.1.3.6. CLINICAL STUDIES18 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Absolute Differences in Peak VO2and QOLThe tables below show the absolute differences between the control and test groups’ peakVO2and QOL over the 6 month follow-up period in the clinical trial.Absolute difference between test and control groups’ change in peak V02over 6monthsBaselineMean ± SD(range)6-monthMean ± SD(range)DifferencewithingroupDifferencebetweengroupsControlgroup(n=41)13.39 ± 4.58(5.02, 24.10)13.12 ± 3.99(3.30, 20.70)- 0.28 1.85Change in PeakVO2(mL/min/Kg)Testgroup(n=91)11.84 ± 3.90(3.50, 26.3)13.41 ± 4.28(6.18, 27.67)1.57Absolute difference between test and control groups’ change in QOL score over6 monthsBaselineMean ± SD(range)6-monthMean ± SD(range)DifferencewithingroupDifference be-tween groupsControlgroup(n=41)47.5 ± 19.29(9, 90.3)31.21 ± 23.96(0, 95)16.29 1.28Changein QOLTestgroup(n=91)52.81 ± 21.84(9, 92)35.24 ± 23.73(0, 93)17.57The 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 scoreitself.QOL score VO2Score Composite ScoreControlGROUPTestGROUPControlGROUPTestGROUPControlGROUPTestGROUP% Im-proved75.6 74.7 48.8 67.0 62.2 70.9% Wors-ened24.4 25.3 51.2 31.9 37.8 28.6% Un-changed0.0 0.0 0.0 1.1 0.0 0.0Histograms for Respiratory Exchange Rate (RER) at peak VO2at baseline and 6 monthfollow-up are provided below:6.1.4.6. CLINICAL STUDIESSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 19
Clinical Results V-V timingV-V programmable settings were available for the clinical study devices as follows: ALTOMSP 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 ofpatients programmed to each combination of Synchronous BiV pacing and V-V delay.The optimization protocol in the clinical study specified that each patient randomized shouldundergo echo guided V-V optimization. Per the investigational plan for the MSP Clinical6.1.5.6. CLINICAL STUDIES20 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Trial, a uniform protocol was used for V-V programming. This protocol required all patientsto undergo echo-guided V-V delay optimization before randomization (2 to 14 days post-implant). The optimal V-V delay was determined by finding the programmable V-V delay andventricular chamber pacing order (RV then LV, or LV then RV) providing the maximum timevelocity integral (TVI or VTI) across the left ventricular outflow tract (LVOT).Only those patients randomized to the Test arm were required to be programmed per theoptimization protocol for the V-V delay.Of the 177 patients that presented at randomization, 3 had Model 617 which does not haveV-V programmability hence the inability to optimize. Of the remaining 174 patients, 154(89%) were tested per the V-V optimization protocol. One hundred forty-nine (149) of the154 patients who were tested per the V-V optimization protocol were programmed per therecommended or randomized V-V delay (97%). Thirty-one (31) patients were programmedto BiV synchronous (V-V delay 0ms), 46 were programmed to Sequential BiV (LV thenRV), 22 were programmed to Sequential (RV then LV), and the remaining 50 patients wererandomized to RV only.A sub-analysis of the composite endpoint comparing the subset of CRT-D patients withoptimized V-V delays vs. the subset of patients that did not undergo V-V delay optimizationdemonstrated similar results in both groups. The CRT-D patients who did not undergo V-Vdelay optimization showed a smaller improvement in the composite endpoint, although thesample size did not permit conclusions based on data from this subset.6. CLINICAL STUDIESSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 21
7. PATIENT SELECTION AND TREATMENTINDIVIDUALIZATION OF TREATMENTExercise 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 mayinfluence selection of programmable parameters. Holter monitoring or other extended ECGmonitoring also may be helpful.CAUTION: To avoid inappropriate therapy during an exercise stress test, do not reprogramany parameter during the test. When a parameter is reprogrammed, algorithm forcesacceleration to "ventricular". During conducted sinus tachycardia within the programmedTachy zone, the device detects a 1:1 fast rhythm. Assuming that acceleration was set toventricular by reprogramming, the device may identify this as a VT, and may immediatelyapply the corresponding therapy.Electrophysiologic (EP) testing:EP testing may be useful for ICD candidates.EP testing may identify the classifications and rates of all the ventricular and atrialarrhythmias, whether spontaneous or during EP testing.Drug resistant supraventricular tachyarrhythmias (SVTs):Drug resistant supraventricular tachyarrhythmias (SVTs) may initiate frequent unwanteddevice 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 amaintenance drug dose rather than a loading dose at the time of ICD implantation. If changesto drug therapy are made, repeated arrhythmia inductions are recommended to verify ICDdetection and conversion. The ICD also may need to be reprogrammed.Changes in a patient’s antiarrhythmic drug or any other medication that affects the patient’snormal cardiac rate or conduction can affect the rate of tachyarrhythmias and/or efficacy oftherapy.Direct any questions regarding the individualization of patient therapy to Sorin’srepresentative.SPECIFIC PATIENT POPULATIONSPregnancy:If there is a need to image the device, care should be taken to minimize radiation exposureto the fetus and the mother.7.1.7.2.7. PATIENT SELECTION AND TREATMENT22 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
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.Handicapped and Disabled Patients:Special care is needed in using this device for patients using an electrical wheel chair orother electrical (external or implanted) devices.7. PATIENT SELECTION AND TREATMENTSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 23
8. PATIENT COUNSELLING INFORMATIONThe physician should consider the following points in counselling the patient about thisdevice:― Persons administering CPR may experience tingling on the patient’s body surface whenthe patient’s ICD system delivers a shock.― Advise patients to carry Sorin ID cards and/or ID bracelets documenting their ICDsystem.8. PATIENT COUNSELLING INFORMATION24 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
9. DECLARATION OF CONFORMITYSorin declares that this device is in conformity with the essential requirements of Directive1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutualrecognition of their conformity (R&TTE).Federal Communication Commission Interference Statement 47 CFR Section 15.19 and15.105(b)The FCC product ID is :―PLATINIUM 4LV SonR CRT-D 1844: YSGCRTDSOR1844This equipment has been tested and found to comply with the limits for a Class B digitaldevice, pursuant to Part 15 of the FCC Rules. These limits are designed to providereasonable protection against harmful interference in a residential installation. Thisequipment generates, uses and can radiate radio frequency energy and, if not installedand used in accordance with the instructions, may cause harmful interference to radiocommunications. However, there is no guarantee that interference will not occur in a particularinstallation.This device complies with Part 15 of the FCC Rules. Operation is subject to the followingtwo conditions: (1) This device may not cause harmful interference, and (2) this device mustaccept any interference received, including interference that may cause undesired operation.FCC Interference Statement 47 CFR Section 15.21 - No Unauthorized ModificationsCAUTION: This equipment may not be modified, altered, or changed in any way withoutsigned written permission from SORIN. Unauthorized modification may void the equipmentauthorization from the FCC and will void the SORIN warranty.Identification of the equipment according Section 95.1217(a)This transmitter is authorized by rule under the Medical Device Radiocommunication Service(in part 95 of the FCC Rules) and must not cause harmful interference to stations operatingin the 400.150-406.00 MHz band in the Meteorological Aids (i.e., transmitters and receiversused to communicate weather data), the Meteorological Satellite, or the Earth ExplorationSatellite Services and must accept interference that may be caused by such stations,including interference that may cause undesired operation. This transmitter shall be usedonly in accordance with the FCC Rules governing the Medical Device RadiocommunicationService. Analog and digital voice communications are prohibited. Although this transmitterhas been approved by the Federal Communications Commission, there is no guarantee thatit will not receive interference or that any particular transmission from this transmitter will befree from interference.IC Requirements for CanadaThe IC product ID is :―PLATINIUM 4LV SonR CRT-D 1844: 10270A-CRTDSOR1844This class B digital apparatus meets all requirements of the Canadian Interference- causingequipment regulations.This device complies with Industry Canada licence-exempt RSS standard(s). Operation issubject to the following two conditions: (1) this device may not cause interference, and (2)9. DECLARATION OF CONFORMITYSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 25
this device must accept any interference, including interference that may cause undesiredoperation of the device.Under Industry Canada regulations, this radio transmitter may only operate using an antennaof 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 shouldbe so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than thatnecessary for successful communication.This device may not interfere with stations operating in the 400.150–406.000 MHz band inthe Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Servicesand must accept any interference received, including interference that may cause undesiredoperation.Cet appareil numérique de la classe B respecte toutes les exigences du règlement sur lematériel brouilleur du Canada.Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareilsradio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) ilne doit pas produire de brouillage, et (2) l’utilisateur du dispositif doit être prêt a acceptertout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettrele fonctionnement du dispositif.Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peutfonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pourl’émetteur par Industrie Canada. Dans le but de réduire les risques de brouillageradioélectrique à l’ intention d’autres utilisateurs, il faut choisir le type d’antenne et son gainde sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensiténécessaire à l’établissement d’une communication satisfaisante.Le présent dispositif ne doit pas causer de brouillage aux stations du service des auxiliairesde la météorologie, des satellites météorologiques, du service d’exploration de la terre parsatellite, exploitées dans la bande 400,150-406,000 MHz, et il doit accepter tout brouillagereçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif.9. DECLARATION OF CONFORMITY26 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
10. PHYSICIAN GUIDELINESPHYSICIAN TRAININGPhysicians should be familiar with sterile pulse generator and left ventricular pacing leadimplant procedures. They must apply these procedures according to professional medicaltraining and experience.Physicians should be familiar with follow-up evaluation and management of patients with animplantable defibrillator (or referral to such a physician).This training guideline for implantation and follow-up of ICD and CRT-D devices comesfrom the Heart Rhythm Society to provide standards for hospital credentialing bodies tohelp ensure appropriate patient care and lead to improved patient outcomes. The followingis a summary of requirements for an alternate training pathway for ICD and CRT-Dimplantations(1):― Documentation of current experience: 35 pacemaker implantations per year and 100implantations over the prior 3 years― Proctored ICD implantation experience: 10 Implantations, 5 Revisions― Proctored CRT-D implantation experience: 5 implantations― Completion of didactic course and/or IBHRE® ExAM― Monitoring of patient outcomes and complication rates― Established patient follow-up― Maintenance of competence: 10 ICD and CRT-D procedures per year, 20 patients peryear in follow-up(1) Please consult full text of both publications for details. 2004 Heart Rhythm Society ClinicalCompetency Statement and the 2005 Addendum on Training Pathways for Implantation ofCardioverter Defibrillators and Cardiac Resynchronization Devices. Heart Rhythm (2004) 3,371-375; Heart Rhythm.DIRECTIONS FOR USEICD operating characteristics should be verified at the time of implantation and recorded inthe patient file. Complete the Patient Registration Form and return it to Sorin, as it providesnecessary information for warranty purposes and patient tracking.Additional programming instructions can be found by accessing Online Help (click the “?” onthe screen) on the Sorin dedicated programmer. Paper copies of Online Help can be obtainedby contacting your Sorin representative.MAINTAINING DEVICE QUALITYThis device is FOR SINGLE USE ONLY. Do not resterilize and reimplant explanted ICDs.Do not implant the device when:― It has been dropped on a hard surface because this could have damaged pulsegenerator components.― Its sterility indicator within the inner package is not green, because it might not have beensterilized.10.1.10.2.10.3.10. PHYSICIAN GUIDELINESSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 27
― Its storage package has been pierced or altered, because this could have rendered itnon-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 longevityor sterility.V-V PROGRAMMING RECOMMENDATIONIt is recommended that V-V optimization testing be performed and used to set the V-V delayfor this device to optimize the potential for RF SonR CRT-D benefit to the patient.10.4.10. PHYSICIAN GUIDELINES28 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
11. PATIENT INFORMATIONInformation for the patient is available in the patient booklet, contained in the outer storagepackage. 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 patienton each return visit or as deemed appropriate.11. PATIENT INFORMATIONSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 29
12. HOW SUPPLIEDSTERILITYThe PLATINIUM defibrillators are supplied one per package in a sterile package.WARRANTY AND REPLACEMENT POLICYSorin warrants its defibrillators. Refer to the section "Warranty" for additional information.Please see the following labelling sections for information concerning the performance of thisdevice: Indications, Contraindications, Warnings and Precautions, and Adverse Events.12.1.12.2.12. HOW SUPPLIED30 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
13. DEVICE DESCRIPTIONThe PLATINIUM 4LV SonR CRT-D 1844 ICD device and programming system. Theprogramming system includes the Sorin dedicated programmer with the SMARTVIEWprogramming software connected to a CPR3 programming head. The programming systemis configured and furnished by Sorin.The PLATINIUM 4LV SonR CRT-D 1844 can serve as a defibrillation electrode (activehousing) with a total surface area of 62.4 cm².The PLATINIUM 4LV SonR CRT-D 1844 is designed to recognize and treat slow or fastVT and VF by continuously monitoring atrial and ventricular activity to identify persistentventricular arrhythmias and to deliver appropriate therapies. PLATINIUM 4LV SonR CRT-D1844 features the PARAD/PARAD+ algorithm, which is specifically designed to differentiateventricular tachycardias from fast rhythms of supraventricular origin. PARAD/PARAD+continuously monitors R-R interval stability, searches for long cycles, assesses the degreeof P-R association, evaluates sudden onset and determines the chamber of arrhythmiaacceleration.In addition to the advanced detection scheme, PLATINIUM 4LV SonR CRT-D 1844 offersprogrammable single, dual or triple-chamber pacing therapy (DDD, DDI, VVI or SafeR(AAI <> DDD) modes) with or without rate-responsive capabilities (DDDR, DDIR, VVIR,DDD/DDIR and SafeR-R (AAIR <> DDDR) modes) using an acceleration sensor. Anautomatic AV delay algorithm as well as a mode switching function are available.PLATINIUM 4LV SonR CRT-D 1844 enables an adjustment of the interventricular delay,and provides the possibility of adapting pacing to each ventricle. The ICD is intendedto resynchronize uncoordinated contraction of the heart by simultaneously or sequentiallypacing both ventricles.PLATINIUM 4LV SonR CRT-D 1844 features simultaneous multipoint left ventricular pacingallowing LV pacing on 2 differents vectors at the same time.PLATINIUM 4LV SonR CRT-D 1844 offers tiered therapy. Therapies can be programmedindependently in each zone:― in the Slow VT and VT zones: two ATP programs, up to two shocks with programmableenergy and up to four shocks with maximum energy can be programmed;― in the VF zone: one ATP program, up to two shocks with programmable energy and upto four shocks with maximum energy can be programmed.The ATP can be applied in RV, LV or RV and LV pacing with a VV delay equal to 0 ms. ATPpacing configuration is independent of ventricular pacing configuration.When the rhythm changes from one zone to another, the device delivers the therapyprogrammed in this zone, starting with the same or more aggressive program for the zone.The ATP program in the VF zone will only be applied if the VT coupling interval is longer thanthe programmed fast VT cycle length.The PLATINIUM 4LV SonR CRT-D 1844 offers biphasic shocks with a maximum storedenergy of 42 J. The shock configuration (electrodes used to apply the shock) can be chosenby programming one of the following combinations: can and one coil, can and two coils, twocoils only.Other features are as follows:― Automatic ventricular sensitivity control13. DEVICE DESCRIPTIONSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 31
― Non-committed shocks― Electrophysiological studies (EPS) with real-time markers or electrograms:― Programmer-controlled VT induction sequences,― Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T),― Programmable electrogram vectors (A / RAring –CAN / RVcoil – CAN / RVtip – CAN/ RVring – CAN/ RVcoil – SVC / SVC – CAN / LVtip1 - LV2 / LVtip1 - RVring / LVtip1– LV4 / LVtip1 – CAN / LV2 - CAN / LV3 – LV2 / LV3- RVring / LV3 - LV4 / LV3 – CAN/ LV2-LV4 / LV4 – CAN) and RV EGM,― Real-time annotations displayed with the markers and indicating the majority rhythm,― Manual ATP sequences,― Manual shocks.― Rescue shock― Follow-up tests:― Pacing lead impedance,― Coil impedance,― Capacitor charge time,― Sensitivity test,― Pacing threshold tests.― Data storage:― Therapy History Report,― Statistics (pace/sense, therapy, shocks, and battery voltage),― Up to 10 episodes and 5 min EGM on significant events: AV block switch, leadimpedance out of range,― Up to 16 complete Holter records with event logs, marker channel notation, andelectrogram records.The PLATINIUM 4LV SonR CRT-D 1844 connector head has three ports:― Atrial “SonR” port: performs atrial bipolar pace/sense if a conventional IS-1 lead isconnected as well as SonR capability if the SonR atrial lead is connected,― LV “IS4” port: performs left ventricular pace,― RV “DF4” port: performs right ventricular bipolar pace/sense, port for RV/SVCdefibrillation coils.Distal lead terminal connections are secured with set-screws accessed via self-sealingsilicone plugs. All lead connections pass through the header into the device via feedthroughs.Programming System:The Sorin programmer is used in conjunction with specific programmer software tointerrogate and program the implanted device at implant and during patient follow-upprocedures.Remote Monitoring:PLATINIUM 4LV SonR CRT-D 1844 is also equipped with the RF wireless technology whichenables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installedat home.13. DEVICE DESCRIPTION32 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
14. IMPLANT PROCEDURENECESSARY EQUIPMENTImplantation of PLATINIUM 4LV SonR CRT-D 1844 requires the following equipment:― Sorin ORCHESTRA programmer, equipped with the SMARTVIEW software interfaceand inductive telemetry head,― Sorin ORCHESTRA PLUS programmer, equipped with the SMARTVIEW softwareinterface, inductive telemetry head and optionally ORCHESTRA PLUS LINK,― pacing system analyzer, as well as its sterile connecting cables, to evaluate the pacingand sensing thresholds,― a complete set of leads with corresponding introducers,― physiological signal monitor capable of displaying simultaneously the surface ECG andarterial pressure,― an external defibrillator with sterile external paddles,― sterile cover for the telemetry head.NOTE: In case you are implanting a DF4 and/or IS4 lead(s), please verify its compatibilitywith standard alligators pin; please refer to the lead user’s manual for more details.PACKAGINGContentsPLATINIUM 4LV SonR CRT-D 1844 and its accessories are ethylene oxide sterilized andhermetically sealed in two-ply clear packaging meeting international requirements.The sterile packaging contains:― the defibrillator― a ratcheting screwdriverAs delivered, PLATINIUM 4LV SonR CRT-D 1844 is programmed to as-shipped values thatare different from nominal values (see Chapter “Programmable Parameters” for details).OPTIONAL EQUIPMENTThe following equipment may be required during implantation of PLATINIUM 4LV SonR CRT-D 1844:― an IS-1 insulating plug to close the atrial port― sterile water to clean traces of blood. Any parts cleaned with sterile water must bethoroughly dried.― mineral oil to lubricate if necessary― a lead cap to isolate a lead which is not used14.1.14.2.14.2.1.14.3.14. IMPLANT PROCEDURESORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 33
BEFORE OPENING THE PACKAGEBefore opening the package, check the "Use by" date printed on the labels on the box andon 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.― if battery voltage is below 3V, and if the last reforming/charge occurred more than oneweek ago, do not implant the device. Otherwise, wait for one more week before checkingthe voltage.NOTE : The battery voltage can decrease before the expiration date is reached. However,the battery voltage should be equal to or higher than 3V at the time of implant.When using the inductive wand, devices MUST NOT be interrogated and/or programmedwithin the vicinity of other devices.Also check the integrity of the sterile package. The sterility of the contents is no longerguaranteed if the package has been pierced or altered. If the defibrillator is no longer sterile, itshould be returned in its packaging to Sorin. Any re-sterilization of the unit is at the discretionof Sorin.PRIOR TO IMPLANTATIONUse the programmer to verify the defibrillator can be interrogated before implantation.Verify all shock therapies are disabled in order to avoid accidental discharge duringimplantation.It is not advisable to program the Smoothing function before implantation, since thedefibrillator may detect noise and pace at a rate higher than the programmed basic rate.CAUTION:Do not shake or tap sharply on the ICD package with the ICD inside, because the ICD'ssensing circuits can interpret this as P-waves or R-waves and record these as an arrhythmiaepisode.High voltage capacitors charge performed on ICD without connected leads using wirelesstelemetry can generate false P-waves or R-waves detection.It is recommended to reset the memory data and statistics before implanting the ICD.DEVICE PLACEMENTThe pocket should be prepared in the left pectoral position, either subcutaneously orsubmuscularly. Subcutaneous device implantation is recommended for optimal RFcommunication efficacy.Implantation in an abdominal position is not advisable.In its final position, the defibrillator should be no more than 4 cm (1.6 in) below the skinsurface.CHOOSING THE TYPE OF LEADThe defibrillator should be connected to:― one bipolar atrial sensing/pacing lead with or without dedicated SonR sensor14.4.14.5.14.6.14.7.14. IMPLANT PROCEDURE34 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
― one DF4 right ventricular lead with bipolar sensing/pacing electrodes and one or twodefibrillation coils (DF4-LLHO or DF4-LLHH)― one IS4-LLLL left ventricular pacing leadThe choice of leads and their configuration is left to the implanting physician’s judgment.Replacement of an existing atrial lead:If the initial lead which was connected to the atrial port of the PLATINIUM 4LV SonR CRT-D1844 was not a SonR lead (i.e. a conventional lead or plug), then do not implant a SonR leadas replacement; possible blood infiltration at the entrance of the connector port may preventproper measurement of the SonR signal.NOTE1: Please note that in the event of defibrillator replacement, DF-1 standard compliantlead is not compatible with DF4 connector and DF4 standard compliant lead is notcompatible with DF-1 connector. Choose the appropriate device compatible with DF-1 orDF4 leads. For any other lead type that requires an adaptor for this device, please contactyour Sorin representative for any information on lead / connector compatibility question.NOTE2: Please note that in the event of defibrillator replacement, IS-1 standard compliantlead is not compatible with IS4 connector. Choose the appropriate device compatible withIS-1 or IS4 leads. For any other lead type that requires an adaptor for this device, pleasecontact your Sorin representative for any information on lead / connector compatibilityquestion.NOTE3: In the event that no atrial lead is implanted, the atrial port should be plugged withIS-1 insulating plug and a single chamber mode (VVI-VVIR) should be programmed. PARADand PARAD+ should not be used.NOTE4: In the event of a warning on a low shock impedance, and after lead replacementor reconnection: it is recommended to check the system integrity (sensing and pacingthresholds and the impedance of the shock electrodes).Connectors:The atrial connector is compatible with the IS-1 standard.The quadripolar right ventricular connector is compatible with the DF4 standard and thequadripolar left ventricular connector is compatible with the IS4 standard.SHOCK CONFIGURATION (+ -> -)The shock configuration is the energy pathway between the defibrillation electrodes. If anatrial coil (SVC) is present, the shock configuration can be programmed for bi-directionalshocks.Programming:When active case and atrial coil (SVC) are both programmed to Yes, the shock configurationcan be programmed to:― RV to Case (or Case to RV),― or RV to SVC (or SVC to RV),― or RV to Case+SVC (or Case+SVC to RV).14.8.14. IMPLANT PROCEDURESORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 35
RV to Case+SVC RV to Case RV to SVCThe polarity of shock is determined by the parameter itself.MEASUREMENT OF THRESHOLDS AT IMPLANTPacing 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 bothventricles and in the atrium.Sensing thresholds:For appropriate right ventricular sensing, the amplitude of the R-wave should be greater than5 mV.For appropriate atrial sensing, the amplitude of the P-wave should be greater than 2 mV.Pacing impedance measurements:Right ventricular, left ventricular and atrial pacing impedances should range from 200 to 3000ohms (refer to the lead characteristics, especially if high impedance leads are used).Please refer to the leads user manuals for more details on the expected electricalperformances of the leads.LEADS CONNECTIONImplant the ventricular leads, then the atrial lead.Each lead must be connected to the corresponding connector port. The position of eachconnector 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. Do not insert a lead connector pin into the connector block without first visually verifyingthat the lead port is not obstructed.4. Insert the screwdriver into the pre-inserted screw socket of the appropriate port (in orderto allow excess air to bleed out and to make the insertion of the lead pin easier).5. Insert the lead pin all the way into the port (check that the pin protrudes beyond the distalconnector block).14.9.14.10.14. IMPLANT PROCEDURE36 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
6. Tighten, check the tightness and ensure the lead pin still protrudes beyond the distalconnector block, and has not moved.CAUTION:1. Do not tighten the pre-inserted screws when there is no lead (this could damage theconnector).2. Do not loosen the screws before inserting the connector (subsequent risk of being unableto reinsert the screw).3. When mineral oil or sterile water is used to make lead insertion easier, the screwdrivershould remain inserted into the pre-inserted screw socket when checking the tightness.As a matter of fact, when the lead port is filled with a liquid, the physics piston effect cangive 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 shaftperpendicular to the plane of the defibrillator (see figure below).6. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold thescrewdriver by its metal part and not by the handle.WARNING: Ensure that the screwdriver's tip is fully inserted in the setscrew; otherwise thescrewdriver can damage the setscrew and prevent connection with or disconnection from thelead.To ensure full insertion, push the screwdriver's hex tip smoothly into the setscrew until itreaches the bottom of the hex chamber in the screw, which can be felt as a solid metalliccontact. Do not implant the defibrillator if there is no feeling of solid metallic contact. Do notimplant the defibrillator if the wrench does not click when attempting to tighten the setscrewon the lead pin.NOTE: To optimize cardioversion/defibrillation shocks, electrodes must be positioned so thatthe electric field between anode(s) and cathode covers the largest myocardial mass. Innormal conditions, the anode and cathode are adequately separated. In case of a short-circuit, the shock may be aborted.In the case of an external defibrillation shock delivered to the patient, always check theprogramming and functioning of the device, in particular its capacity to deliver shocks.14. IMPLANT PROCEDURESORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 37
DEVICE IMPLANTATIONPLATINIUM 4LV SonR CRT-D 1844 should be implanted with the device identificationengraved side facing outwards for optimal communication with the programming head andradiographic identification.In order to prevent lead damage or dislodgement, it is important to loosely coil the leads andplace them in a manner that minimizes lead tension, twisting, sharp angles, and pressure.The following factors should be considered in placing any excess of lead length:1. recommendations/warnings of the (other) associated leads,2. patient anatomy, and3. pulse generator size and motion.Suture the casing connector to the muscle using the hole provided for this purpose, in orderto avoid potential migration of the device into the pectoral muscle.TESTS AND PROGRAMMINGDuring the implant testing procedure:It is recommended that a safety margin of at least 10 J be demonstrated between theeffective 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 of30 to 150 ohms. Check the lead connection if the values are outside these boundaries.Save the programming data on the programmer’s hard disk and on an external storagedevice (if desired).Resuscitation Availability:Do not perform device testing unless an external defibrillator is available and medicalpersonnel skilled in cardiopulmonary resuscitation (CPR) are present.Disable the ICD During Handling:Program Shock Therapy to OFF during surgical implant and explant or post mortemprocedures. The device can deliver a serious high energy shock should accidental contactbe made with the defibrillation electrodes, the device can deliver a very high energy shock.14.11.14.12.14. IMPLANT PROCEDURE38 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
15. SPECIAL MODESSAFETY MODE (NOMINAL VALUES)Nominal values may be rapidly restored by pressing the following button on the programminghead 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 ofprogrammable parameters.MAGNET MODEWhen the magnet is applied:― antiarrhythmia functions are inhibited (detection of rhythm disturbances, charging, andtherapy),― hysteresis, VV delay and AVD paced/sensed offset are set to 0,― pacing amplitude is set to 6 V,― pulse width is set to maximum,― the following functions are disabled: ventricular arrhythmia prevention, Mode Switch,Anti-PMT, Smoothing, Rate Response.When the magnet is removed:― arrhythmia detection algorithms and sequential therapies are reinitialized,― therapies start with the least aggressive program for each area.The antiarrhythmia functions inhibition is extended after magnet removal if a charge occurredjust before the application of the magnet in order to ease the communication between thedevice and the programmer.The other parameters remain at their programmed value, including the ventricular pacedchamber parameter.RESPONSE IN THE PRESENCE OF DISTURBANCEIf the defibrillator senses electrical noise at a frequency above 16 Hz, it switches to anasynchronous mode at the basic rate. The programmed mode is restored as soon as thenoise is no longer detected.Ventricular pacing may also be inhibited by ventricular noise. It can be restored by setting theparameter “V pacing on noise” to “On”.DETECTION CHARACTERISTICS IN THE PRESENCE OFELECTROMAGNETIC FIELDSPer Clause 27.4 of Standard EN 45502-2-2, detection in the presence of electromagneticfields is characterized as follows:― Differential mode:15.1.15.2.15.3.15.4.15. SPECIAL MODESSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 39
― Common mode rejection ratio:16.6 Hz 50 Hz 60 HzAtrial channel ≥74 dB ≥74 dB ≥74 dBVentricularchannel≥68 dB ≥68 dB ≥68 dBFor atrial sensitivity settings below 0.4mV, the ICD may detect noise lower than the levelspecified 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 levelspecified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz.PROTECTION AGAINST SHORT-CIRCUITSThe defibrillator can undergo a short-circuit if the anode and cathode are not adequatelyseparated.In this case, the shock is aborted and a warning will indicate that a short circuit (shockimpedance < 20 ohms) was detected during the last shock. The device may be damagedcompromising ability to provide shock therapy.15.5.15. SPECIAL MODES40 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
16. MAIN FUNCTIONSAUTOMATIC LEAD MEASUREMENTSAutomatic pacing lead impedance measurement:A lead impedance measurement is automatically performed on atrial and ventricular leadsevery 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 perday. The coil impedance is stored for each coil.Automatic sensing measurement:The amplitude of P and R waves are automatically measured at each cycle. Every 8.5minutes, the amplitude of the last 8 P and R detections are averaged and stored.ATRIAL TACHYARRHYTHMIA MANAGEMENTMode Switch:This function is designed to limit the acceleration and variation of ventricular rate in thepresence of atrial arrhythmia.VENTRICULAR TACHYARRHYTHMIA MANAGEMENTVentricular tachyarrhythmia prevention:Set of algorithms that can be used to avoid the circumstances of ventricular tachyarrhythmiaonset.Arrhythmia discrimination algorithm PARAD and PARAD+ (P And R basedArrhythmia Detection):PARAD is the algorithm used to discriminate sinus tachycardias (ST) and supraventriculartachycardias (SVT) from ventricular tachycardias (VT).PARAD+ is based on the PARAD algorithm but additionally takes into account the “AFdetect” discrimination criteria: the occurrence of a "long ventricular cycle" characteristic forAF patients which is an additional arrhythmia classification criterion to improve identificationof atrial fibrillation and avoid inappropriate shocks.Fast VT treatment:Applies detection criteria on fast ventricular tachycardia that are different from those of theVT zone, as well as different therapies. The fast VT zone is included in the VF zone: itslower limit is determined by the programmed value for the VF zone and its upper limit by theprogrammed value for the fast VT zone.Polarity alternation on Max shock:Reverses the programmed polarity of every second shock set at maximum energy. Thenumber, type, and energy of shocks is independently programmable by detection zone.16.1.16.2.16.3.16. MAIN FUNCTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 41
Defibrillation threshold (DFT):Be aware that the changes in the patient’s condition, drug regimen, and other factorsmay change the defibrillation threshold (DFT) which may result in non-conversion of thearrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventriculartachycardia during arrhythmia conversion testing is no assurance that conversion will occurpost-operatively.PACINGBTO (Brady Tachy Overlap):Enables cardiac resynchronization therapy within the slow VT zone to preserve patientexercise capacity, without affecting detection or treatment of slow VTs.Post-shock mode:After any automatic shock therapy, the post-shock mode makes it possible to apply a pacingmode other than the standard antibradycardia pacing mode and/or with different pacingparameters.SafeR (AAI <> DDD) mode:Is intended to minimize deleterious effects of ventricular pacing. The defibrillator functions inAAI mode, and temporarily switches to DDD mode upon the occurrence of AVB III, AVB II,AVB I and ventricular pause.Anti-PMT protection:Is intended to protect the patient from Pacemaker-Mediated Tachycardia (PMT) withoutreducing atrial sensing capability of the device.SENSINGAutomatic Refractory Periods:Optimize sensing and make the implant programming easier. These periods are composedof a minimal Refractory Period and a triggerable Refractory Period. The duration of therefractory periods lengthens automatically as needed.Committed period:In DDI or DDD modes, the committed period is a non-programmable 95 ms ventricularrelative refractory period that starts with atrial pacing. If a ventricular event is sensed duringthe committed period, but outside the blanking period, the ventricle is paced at the end ofthe committed period. The committed period prevents inappropriate ventricular inhibition ifcrosstalk occurs.Protection against noise:Allows the distinction between ventricular noise and ventricular fibrillation. If the devicesenses ventricular noise, the ventricular sensitivity is decreased until noise is no longerdetected. 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 ofwide QRS waves. The device automatically adjusts the sensitivities based on the ventricularsensing amplitude. In case of arrhythmia suspicion or after a paced event, the programmedventricular sensitivity will be applied. The minimum ventricular sensitivity threshold is 0.4 mV(minimum programmable value).16.4.16.5.16. MAIN FUNCTIONS42 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
SONR CRT OPTIMIZATIONSonR is a specific sensor, located at the tip of the atrial lead, that picks-up micro-accelerationsof the heart walls to derive information pertaining to cardiac contractility. The signal picked-up by the SonR sensor can be processed by PLATINIUM 4LV SonR CRT-D 1844 in orderto automatically adjust VV delays and AV delays during rest and exercise for optimalresynchronization therapy. In addition, the SonR signal is recorded during tachyarrhythmiaepisodes to depict acute variations of cardiac contractility. PLATINIUM 4LV SonR CRT-D1844 can also transmit real-time SonR signals via telemetry.LV MULTIPOINT PACING (MP)PLATINIUM 4LV SonR CRT-D 1844 features simultaneous multipoint left ventricular pacingallowing LV pacing on 2 differents vectors at the same time, named MP1 and MP2 LV pacingsites.FOLLOW-UP FUNCTIONStorage of memory data:AIDA (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6months of patient follow-up with day by day data collection, or up to 24 hours with hourly datacollection. Episodes of ventricular tachyarrhythmia are recorded with one programmableEGM channel which can be selected, in addition to RV EGM.Alerts / Warnings:The device routinely performs security self-checks and technical measurements to ensuresystem integrity. When system integrity is found to be at risk outside a follow-up, alerts arestored in the device memory. When system integrity is found to be at risk during a follow-up, the information is managed by a warning (pop-up message) to immediately notify theuser. For example, the following types of events can trigger a warning or an alert: technicalproblem during a shock, lead impedance or shock continuity measurements out-of-range,battery depletion, …REMOTE MONITORING FUNCTIONRemote monitoring enables the automatic remote transmission of implant data to thephysician thanks to the wireless Radio Frequency (RF) communication ability of the implant inorder to provide a comprehensive report to the physician about device functioning and patientcardiac status without having the patient physically in the clinic.The data is transmitted from the implant to the SMARTVIEW monitor, a small transmitterplaced in the patient's home.Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then routedthrough the phone line or via GPRS to an internet website. This website is responsible fortransforming the implant data into a comprehensive report that can be consulted by thephysician.SMARTVIEW MonitorThe SMARTVIEW monitor is a small device equipped with an RF transmission module tocommunicate with the implant and a modem to export data through the internet.The SMARTVIEW monitor is delivered to the patient who has to install it at home. Preferablythe SMARTVIEW monitor will be placed on the nightstand of the patient, as close as possibleto the side of the bed where the patient usually sleeps. The SMARTVIEW monitor connectsto the phone line of the patient and the power plug. Regular transmissions are done during16.6.16.7.16.8.16.9.16.9.1.16. MAIN FUNCTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 43
the night when the patient is asleep next to the SMARTVIEW monitor without any interventionfrom the patient.Transmission triggerThere 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 abnormalevents. The list of abnormal event is available in a following paragraph. Alert conditionsare checked daily.― the on-demand follow-up transmission is triggered by the patient himself through theuse of a specific button on the SMARTVIEW monitor.Data transmittedThe data transmitted are identical to the data available during a standard interrogation withthe dedicated programmer. All counters, histograms, IEGMs and diagnosis available in thedevice are transmitted containing (not an exhaustive list):― programmed parameters― information on patient and system implanted― battery status― lead status (brady leads and defibrillation coils)― pacing counters and mean heart rate (brady)― atrial and ventricular arrhythmia counters and episodes― ventricular therapy countersData are presented in the form of 2 reports to the physician: the first one contains a summaryof major counters, histograms, warnings and diagnosis. The second one presents the mostimportant IEGM episodes automatically selected based on the degree of severity for thepatient.User websiteOn 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 reportsAlert systemThe following set of alert triggers can be independently programmed ON/OFF by thephysician using the dedicated programmer and can trigger an alert transmission:― Low or high lead impedance (A, RV, LV) (if MP is ON, both MP1 and MP2 can trig thealert)― Abnormal coil impedance (shock lead)― Low or high shock impedance― Inefficient high energy shock16.9.2.16.9.3.16.9.4.16.9.5.16. MAIN FUNCTIONS44 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
― All shocks programmed OFF― Shock treated VT/VF― ATP treated VT/VF― Lack of V pacing in CRT device― Suspicion of noise on the V lead― AT/AF occurrence― Fast V rate during AT/AFThe following set of alert triggers (system alerts) cannot be deactivated when the Alerts areprogrammed “On” and can trigger an alert transmission:― Battery depletion – RRT― Device reset― Excessive charge time (>25s)― System integrityWARNING: 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 beextended.16. MAIN FUNCTIONSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 45
17. PATIENT FOLLOW-UPFOLLOW-UP RECOMMENDATIONSBefore 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 batterywill recover its steady state value.Automatic capacitor charging may affect communication between the device and theprogrammer.― check the integrity of the pacing and defibrillation leads,― check for proper sensing (sensitivity, crosstalk) and pacing ; set the pacing amplitude totwice the pacing threshold,― interrogate the implant memories (AIDA),― check the efficacy of the therapies delivered,― keep a printout of programmed parameters, test results, and memory data,― reset the memory data and statistics.These operations should be performed by medical personnel in an appropriate care unit, withresuscitation equipment present.It is recommended that a routine follow-up examination be done one month after discharge,and then every three months until the device nears the replacement date.Refer to the online help for a description of displayed warnings, and the necessity to contactSorin for an evaluation.Implant software upgrade:In case a new implant software is downloaded in the device memory through theprogrammer, a warning message could be displayed by the programmer to inform the userand give the correct instructions to follow.HOLTER FUNCTIONThe Holter records markers and EGM on RV and on 1 programmable channel: A / RAring –CAN / RVcoil – CAN / RVtip – CAN / RVring – CAN/ RVcoil – SVC / SVC – CAN / LVtip1 -LV2 / LVtip1 - RVring / LVtip1 – LV4 / LVtip1 – CAN / LV2 - CAN / LV3 – LV2 / LV3- RVring /LV3 - LV4 / LV3 – CAN / LV2-LV4 / LV4 - CAN:― Up to 10 episodes and 5 min EGM on significant events: AV block switch, leadimpedance out of range.― Up to 16 tachyarrhythmia episodes as well as the therapy history.17.1.17.2.17. PATIENT FOLLOW-UP46 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Stored Tachyarrythmia Episodes:PLATINIUM 4LV SonR CRT-D 1844 stores up to 16 episodes (VF, VT, Slow VT, SVT/ST, non-sustained) with a total of 25.6 min of high resolution EGM and 5 min of SonR signal.For each episode four levels of details are presented:― Tachogram (to visualize RR, PP, PR and RP intervals)― Event log for the entire episode:― PARAD/PARAD+ analysis for each majority,― Delivered therapies,― Markers: Atrial, ventricular and biventricular markers, sensed, paced and in relativerefractory periods,― EGM: onset and detection of the arrhythmia, on two therapies, and the return to slowrhythm by recording electrogram.Therapy historyFor each arrhythmia detection, each therapy delivered (either automatically or during anelectrophysiological study) and at the end of each arrhythmia, PLATINIUM 4LV SonR CRT-D1844 records the type of majority rhythm, the number of ATP sequences delivered, the energyand the number of shocks delivered.RECOMMENDED REPLACEMENT TIME (RRT)Recommended Replacement Time (RRT)(1) is controlled by: battery voltage equal to 2.62 V ±0.01 VCAUTION: The defibrillator should be replaced as soon as the Recommended ReplacementTime (RRT) point is reached.Between the RRT and the EOS (End of Service)(2), PLATINIUM 4LV SonR CRT-D 1844 canstill function for:― 10.8 months (100% atrial and biventricular pacing in DDD mode, 500 ohms, with as-shipped settings), and deliver 11 shocks at 34 J or― 10,4 months (0% pacing, sensors OFF) and deliver 21 shocks at 34 J.Once the Recommended Replacement Time (RRT) point has been reached, the deviceoperates normally, except that the charge time increases. Under normal conditions (andwithout programmer use) the charge times are as follows:Shock energy Charge time (sec)BOS(3) 42 J 10 (± 2)RRT 42 J 13 (± 3)(1) Recommended Replacement Time (RRT) corresponds to Elective Replacement Indicators(ERI) previously used.(2) End of Service (EOS) corresponds to End of Life (EOL) previously used.(3) Beginning of Service (BOS) corresponds to Beginning of Life (BOL) previously used.EXPLANTATIONThe defibrillator should be explanted in the following cases:17.3.17.4.17. PATIENT FOLLOW-UPSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 47
― The Recommended Replacement Time (RRT) point is reached― Confirmed malfunction― Burial of the patient (for environmental reasons, the local regulation may require theexplantation 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.All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces ofcontamination. Cleaning may be done by immersing them in an aqueous sodium hypochloritecontaining at least 1% chlorine, followed by rinsing copiously with water.The defibrillator should be protected against mechanical impact and the temperaturevariations that may occur during shipping.Before explantation, it is advisable to:― Print out all programmed parameters, statistics and Holter function report,― Save Patient data on floppy disk or hard disk,― Disable shock therapies (VT and VF) to avoid any risk of untimely shock.DEFIBRILLATOR IDENTIFICATIONThe defibrillator can be interrogated and programmed via telemetry, using the programminghead interfaced with the Sorin dedicated programmer.Position the programming head over the telemetry antenna located in the upper part of thedevice, in order to communicate effectively via telemetry (see diagram below).The device can be non-invasively identified as follows:1. Take an x-ray to identify the name of the manufacturer and model, printed on the device(X-ray ID is SEA for PLATINIUM range).2. Interrogate the device using the Sorin dedicated programmer. The model and serialnumber of the device are automatically displayed. The first figure in the serial numbercorresponds to the last figure in the year of manufacture.17.5.17. PATIENT FOLLOW-UP48 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
18. SUPPLEMENTAL INFORMATIONClinical 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. Thedata provided are applicable to PLATINIUM 4LV SonR CRT-D 1844.ADVERSE EVENTS IN THE SAFER (AAI <> DDD) STUDYClinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in45 patients. No serious adverse events were device- or feature-related. There were no deathsin the study.Table 1: Summary of Symphony safety data during studyPatients Number of eventsNumberof pa-tients% ofpatientsNumberofeventsEvents perdevice year(a)Deaths 0 0 0 0Explants 0 0 0 0Serious pacemaker related events outsidethe use of SafeR (AAI <> DDD)0 0 0 0Non-serious pacemaker related events out-side the use of SafeR (AAI <> DDD)0 0 0 0Serious events due to the use of SafeR(AAI <> DDD)0 0 0 0Non-serious events related due to the useSafeR (AAI <> DDD)13 28.9 15 3.2Serious non-pacemaker related events 6 13.3 9 1.9Non-serious non-pacemaker related events 8 17.8 8 1.7(a) 4.74 device yearsNon-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on2nd degree AV block, inappropriate classification of a PAC, disagreement between markersand recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave ina refractory period, and disagreement in the statistics for switches to DDD. No patientsymptoms were associated with these events.SAFER (AAI <> DDD) CLINICAL STUDYSafeR (AAI <> DDD) mode in PLATINIUM is similar to that in Symphony.The differences in SafeR (AAI <> DDD) mode between the two devices are:― To prevent long RR intervals during VT/VF, SafeR (AAI <> DDD) has no effect duringVT/VF therapy, electrophysiologic studies, and post-shock recovery.― The maximum acceptable AV delay for first degree AV block varies as a function ofpacing rate.― PLATINIUM requires a ventricular sensed event to atrial paced event (RA) interval of atleast 100 ms. Therefore, the device lengthens the atrial escape interval so that it ends atleast 102 ms after the ventricular event.18.1.18.2.18. SUPPLEMENTAL INFORMATIONSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 49
― During atrial fibrillation episode, pause criterion is fixed to 2s to avoid long bradycardiaepisodes in switching to DDD mode.Despite these differences, the data collected on Symphony devices are applicable toPLATINIUM because the principles of SafeR (AAI <> DDD) operation did not change. Thecriteria for switching from AAI to DDD (or vice versa) did not change. The device’s method forevaluating the presence of AV conduction did not change.Methods:All patients were implanted with a Symphony Model 2550 dual-chamber rate-responsivepacemaker with SafeR (AAI <> DDD) mode. A variety of marketed atrial and ventricularpacing leads were used. The pacemaker was programmed and interrogated via bi-directionaltelemetry using a Sorin dedicated programmer and a CPR3 programming head.The study’s routine evaluation consisted of enrollment, pre-discharge evaluation, and ascheduled follow-up visit at one month. At pre-discharge, a 24-hour Holter recording wasperformed and pacemaker memory was read. At one month, pacemaker memory was read.Investigators also documented adverse events.Patients studied:A total of 45 patients from 12 centers had Symphony 2550 pacemakers with SafeR (AAI <>DDD). Of these, 14 (31 %) were female and 31 (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 (AAI <> DDD) mode, the percentage of ventricularpacing provided over one month was recorded from pacemaker memory.Thirty-five patients contributed data to evaluate the percentage of ventricular pacing providedwith SafeR (AAI <> DDD). Twenty-nine patients had 1 % or less ventricular pacing and sixpatients had a range of 28-97 % ventricular pacing. The graph below shows the distributionof ventricular pacing observed in patients with and without AV block as a primary indicationfor implant.The graph shows that many patients programmed to SafeR (AAI <> DDD) had less than 1%ventricular pacing:18. SUPPLEMENTAL INFORMATION50 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
― 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 AVblock indication at implant.The actual reduction of ventricular pacing that SafeR (AAI <> DDD) provides in an individualwill depend on the amount of time that the patient spends in AV block. SafeR (AAI <> DDD)cannot and should not provide any decrease in ventricular pacing while the patient is in AVblock.(1) Pioger G, Jauvert G, Nitzsché R, Pozzan J, Laure H, Zigelman M, Leny G, Vandrell M,Ritter P, and Cazeau S. Incidence and predictive factors of atrial fibrillation in paced patients.PACE, 28, Supp 1: S137-141; January 2005. This was a prospective observational study of377 patients with a functionally similar device programmed to DDD. The primary indicationsfor implant were: AV block (49 %), sinus node disease (16 %), brady-tachy syndrome (5 %),AV block + sinus node disease (19 %), AV block + brady-tachy syndrome (6 %), and brady-tachy syndrome + sinus node disease (5 %).18. SUPPLEMENTAL INFORMATIONSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 51
19. PHYSICAL CHARACTERISTICSDimensions 78.1 x 54.3 x 11.1 mmWeight 91 gVolume 33.7 cm3Active surface areaof casing62.4cm2Connector Atrium: SonR (IS-1 bipolar compatible). Right ventricle: DF4. Left ventricle:IS4.MATERIALS USEDActive surface areaof casing99% pure titaniumConnectors Polyurethane* and silicone elastomer**Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications.19.1.19. PHYSICAL CHARACTERISTICS52 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
20. ELECTRICAL CHARACTERISTICSAtrial input impedance 80 kilohms ± 30 %Ventricular input impedance 80 kilohms ± 30 %D.C. capacitance 149 µF ± 8 %Capacitor reformation No reformation requiredRate limit 192 ppm ± 10 ppmPacing waveformDefibrillation waveformTABLE OF DELIVERED SHOCK ENERGY AND VOLTAGEThe 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 isas follows:Stored energy (J) 0.5 10 20 34 42V1 (Volt) 71 332 471 617 686V2 (Volt) 35 167 235 309 342Delivered E:Phase 1 (J)0.32 6.94 14.0 23.8 29.6Delivered E:Phase 2 (J)0.08 1.75 3.4 6.0 7.4Delivered E: Total(J)0.4 8.7 17.4 30 37Tolerances are 12% for voltage (25% at 0.5 J) and 30% for energy.BATTERYManufacturer GreatbatchType Quasar High Rate (QHR)Model GB 3070Number of batteries 1Total capacity 2192 mAhUsable capacity Between BOS and RRT:1530 mAh.Between BOS and EOS:1910 mAh.20.1.20.2.20. ELECTRICAL CHARACTERISTICSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 53
Voltage BOS: 3.24 V. RRT: 2.62 V. EOS:2.5 V.LONGEVITYThe longevities are calculated by taking into account 6 months storage with the followingconditions:― Mode: DDD― Basic rate: 60 ppm― Pulse width (A, RV, LV): 0.35 ms― EGM:ON― SonR: ON― MP: OFF― 2 battery reformings per year (at 34J), replaced by shocks if any― Remote monitoring: ON, daily check, 4 follow-ups and 5 full alert reports per year― RF telemetry: ON, 120min at implantation + 15min at discharge + 15min for in-clinicquarterly follow-upsLongevity projection at 500 Ω pacing impedance:A pacing (%) 100 100 1 15 1 30 0BiV pacing (%) 100 100 100 100 100 100 0A, RV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 -LV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 3.0 -Sensor OFF ON ON ON OFF OFF OFFMax shocks (42J) per year 4 4 4 4 0 3 4Longevity (years) 6.8 6.7 7.8 6.3 11.1 9.6 12.2Longevity projection at 600 Ω pacing impedance:A pacing (%) 100 100 1 15 1 30 0BiV pacing (%) 100 100 100 100 100 100 0A, RV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 -LV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 3.0 -Sensor OFF ON ON ON OFF OFF OFFMax shocks (42J) per year 4 4 4 4 0 3 4Longevity (years) 7.3 7.1 8.2 6.7 11.6 10.0 12.2Longevity projection at 700 Ω pacing impedance:A pacing (%) 100 100 1 15 1 30 0BiV pacing (%) 100 100 100 100 100 100 0A, RV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 -LV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 3.0 -Sensor OFF ON ON ON OFF OFF OFFMax shocks (42J) per year 4 4 4 4 0 3 4Longevity (years) 7.6 7.5 8.5 7.1 11.9 10.3 12.220.3.20. ELECTRICAL CHARACTERISTICS54 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
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 deviceoperating under the conditions described in the tables above, with MP activated for theentire lifetime of the device from implant to explant, with the same LV pacing parameters (LVamplitude, LV pulse width) and impedance applied on both LV vectors (MP1 and MP2).1h of additional RF programming session reduces the device longevity from 1 to 2 weeksdepending on the device functioning mode (no pacing, 100% pacing). The mean longevity asa function of shocks delivered at maximum energy, with and without pacing, is as follows:The mean longevity as a function of yearly remote follow-ups1, with and without pacing, is asfollows:1. An excessive number of remote follow-ups can have a non-negligible impact on devicelongevity.20. ELECTRICAL CHARACTERISTICSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 55
21. PROGRAMMABLE PARAMETERSMeasured at 37 °C under a 500 ohm load.ANTIBRADYCARDIA PACINGBasic parameters Values Nominal value "As shipped"valueMode VVI-VVIR-DDD-DDDR-DDD/DDIR-DDI-DDIR-SafeR (AAI <=> DDD)-SafeR-R (AAIR <=> DDDR)-DOO-VOO-OOOVVI DDDBasic rate (ppm) (1) From 30 to 90 by steps of 5 (± 4 %) 60 60Maximum rate (ppm) From 100 to 145 by steps of 5 (± 6 %) 120 120Rate hysteresis (%) 0-5-10-20-35 (± 18 ms) 0 0Rest AV delay (ms) 30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-155-165-170-180-190-195-205-210-220-225-235-250(± 19 ms)125 125Exercise AV delay(ms)30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-155-165-170-180-190-195-205-210-220-225-235-250(± 19 ms)80 80AVD Paced/SensedOffset (ms)0-10-15-25-30-40-45-55-65-70-80-85-95-100-110-115-125 (± 1 ms)65 65(1) The corresponding periods are (in ms):2000-1714-1500-1333-1200-1091-1000-923-857-800-750-706-667 ms.Special features Values Nominal value "As shipped"valueRate smoothing OFF-Very slow-Slow-Medium-Fast OFF OFFMode Switch ON-OFF ON ONPhysical activity Very low-Low-Medium-High-Very high Medium MediumExercise AV opt. rate(ppm)From 70 to 120 by steps of 5 90 90CRT optimization OFF-Monitor-AV-AV+VV OFF OFF21.1.21. PROGRAMMABLE PARAMETERS56 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Pacing/Sensing Values Nominal value "As shipped"valueAtrial sensitivity (mV)(1) From 0.2 to 4 by steps of 0.2 (± 50 %) 0.4 0.4Atrial amplitude (V)(2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5Atrial pulse width(ms)0.12-0.25-0.35-0.5-0.6-0.75-0.85-1(± 10 %)0.35 0.35Ventricular sensitivity(mV) (1) From 0.4 to 4 by steps of 0.2 (± 50 %) 0.4 0.4RV amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1(± 10 %)0.35 0.35LV amplitude (V) (2) 0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7 (± 20 %)5 3.5LV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35LV pacing polarity [LV tip1-CAN]-[LV tip1-LV2]-[LV tip1-RV ring]-[LV tip1-RV coil]-[LV tip1-LV4]-[LV2-CAN]-[LV2- RV coil]-[LV2 -LV4]-[LV3-CAN]-[LV3-LV4]-[LV3-LV2]-[LV3-RV ring]-[LV3-RVcoil]-[LV4-RV coil][LV tip1-LV2] [LV tip1-LV2]Multipoint LV Pacing(MP)ON-OFF OFF OFFV chambers Right-R+L-L+R R+L R+LVV delay (ms) 0-16-24-32-40-48-56-64 (± 3 ms) 0 0(1) Values are measured using a positive and negative triangular signal of 2/13 ms.(2) The correlation between the programmed amplitudes, the stored amplitudes and the mid-pulsedelivered amplitudes under a 500 ohm load are given in the following table:Programmedamplitude(V)Storedamplitude(V)Mid-pulsedeliveredamplitude(V)0.10* 0.20 0.190.25* 0.26 0.220.35* 0.39 0.330.50* 0.52 0.440.60* 0.72 0.610.75* 0.85 0.720.85* 0.98 0.831.00 1.11 0.94Programmedamplitude(V)Storedamplitude(V)Mid-pulsedeliveredamplitude(V)1.10* 1.24 1.051.25* 1.37 1.161.35* 1.50 1.271.50 1.63 1.381.60* 1.76 1.491.75* 1.89 1.601.85* 2.02 1.712.00 2.10 1.7821. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 57
Programmedamplitude(V)Storedamplitude(V)Mid-pulsedeliveredamplitude(V)2.10* 2.21 1.872.25* 2.34 1.982.35* 2.47 2.092.50 2.60 2.202.60* 2.73 2.312.75* 2.87 2.422.85* 3.00 2.533.00 3.15 2.673.10* 3.26 2.763.25* 3.39 2.873.35* 3.52 2.983.50 3.65 3.093.60* 3.78 3.203.75* 3.91 3.313.85* 4,04 3.424.00 4.20 3.554.10* 4.30 3.644.25* 4.43 3.754.35* 4.56 3.864.50 4.69 3.97Programmedamplitude(V)Storedamplitude(V)Mid-pulsedeliveredamplitude(V)4.60* 4.82 4.084.75* 4.95 4.194.85* 5.08 4.305.00 5.25 4.445.10* 5.34 4.525.25* 5.47 4.635.35* 5.60 4.745.50* 5.73 4.855.60* 5.86 4.965.75* 5.99 5.075.85* 6.12 5.186.00 6.30 5.336.10* 6.38 5.406.25* 6.51 5.516.35* 6.64 5.626.50* 6.77 5.736.60* 6.90 5.846.75* 7.03 5.956.85* 7.16 6.067.00* 7.35 6.22* For left ventricular amplitude only.If Multipoint LV Pacing (MP) is set to ON, LV pacing parameters (LV amplitude, LV pulse widthand LV pacing polarity) are replaced by the following parameters:21. PROGRAMMABLE PARAMETERS58 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Pacing/Sensing Values Nominal value "As shipped"valueLV amplitude – MP1(V) (1) 0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7- (± 20 %)5 3.5LV pulse width –MP1 (ms)0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35LV pacing polarity –MP1[LV tip1-CAN]-[LV tip1-LV2]-[LV tip1-RV ring]-[LV tip1-RV coil]-[LV tip1-LV4]-[LV2-CAN]-[LV2- RV coil]-[LV2 -LV4][LV tip1-LV2] [LV tip1-LV2]LV amplitude – MP2(V) (1) 0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7- (± 20 %)5 3.5LV amplitude – MP2(ms)0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35LV pacing polarity –MP2[LV3-CAN]-[LV3-LV4]-[LV3-LV2]-[LV3-RV ring]-[LV3-RVcoil]-[LV4-RV coil][LV3-LV4] [LV3-LV4](1) The correlation between the programmed amplitudes, the stored amplitudes and the mid-pulsedelivered amplitudes under a 500 ohm load are given in the table above.Ventricular arrhyth-mia algorithmsValues Nominal value "As shipped"valueAtrial pacing on PVC Yes-No No NoPost extrasystolicpause suppressionYes-No No NoAcceleration on PVC Yes-No No NoMax accelerationrate (ppm)From 60 to 145 by steps of 5 100 10021. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 59
Post-shock mode Values Nominal value "As shipped"valueMode OFF-VVI-DDI-DDD OFF OFFDuration 10s-20s-30s-1min-2min-3min-4min-5min 20s 20sBasic rate (ppm) From 50 to 90 by steps of 5 (± 4 %) 60 60Rest AV delay (ms) 30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-155-165-170-180-190-195-205-210-220-225-235-250(± 19 ms)125 125Exercise AV delay(ms)30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-155-165-170-180-190-195-205-210-220-225-235-250(± 19 ms)80 80AVD Paced/SensedOffset (ms)0-10-15-25-30-40-45-55-65-70-80-85-95-100-110-115-125 (± 1 ms)65 65A amplitude (V) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5A pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1(± 10 %)0.35 0.35RV amplitude (V) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) 5 3.5RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1(± 10 %)0.35 0.35LV amplitude (V) 0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7 (± 20 %)5 3.5LV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35If Multipoint LV Pacing (MP) is set to ON, LV pacing parameters (LV amplitude, LV pulse widthand LV pacing polarity) are replaced by the following parameters:21. PROGRAMMABLE PARAMETERS60 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Post-shock mode Values Nominal value "As shipped"valueLV amplitude – MP1(V)0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7 (± 20 %)5 3.5LV pulse width –MP1 (ms)0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35LV amplitude – MP2(V)0.1-0.25-0.35 (± 80 %)0.5-0.6-0.75-0.85 (± 30 %)1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2-2.1-2.25-2.35-2.5-2.6-2.75-2.85-3-3.1-3.25-3.35-3.5-3.6-3.75-3.85-4-4.1-4.25-4.35-4.5-4.6-4.75-4.85-5-5.1-5.25-5.35-5.5-5.6-5.75-5.85-6-6.1-6.25-6.35-6.5-6.6-6.75-6.85-7 (± 20 %)5 3.5LV amplitude – MP2(ms)0.12-0.25-0.35-0.5-0.6-0.75-0.85-1-1.1-1.25-1.35-1.5-1.6-1.75-1.85-2 (± 10 %)0.35 0.35Refractory periods Values Nominal value "As shipped"valueAtrial refractory peri-od post ventricularsensing (ms)45-65-80-95-110-125-140-155 (± 16 ms) 45 45Atrial refractory peri-od post ventricularpacing (ms)80-95-110-125-140-155 (± 4 ms) 80 80Sensitivity margins Values Nominal value "As shipped"valueAtrial post pac-ing/sensing margin(mV)From 0 to 1 by steps of 0.2 0.4 0.4Ventricular post pac-ing margin (mV)From 0 to 2 by steps of 0.2 0.8 0.8Response to noise Values Nominal value "As shipped"valueAutomatic sensitivityon noiseON-OFF ON ONV pacing on noise ON-OFF OFF OFFSafeR parameters Values Nominal value "As shipped"valueAVB I switch Rest+Exercise-Exercise Exercise Rest+ExerciseLong PR: max (ms) From 200 to 500 by steps of 50 450 450Long PR: min (ms) From 200 to 500 by steps of 50 250 250Max. pause (s) 2-3-4 3 321. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 61
VENTRICULAR TACHYARRHYTHMIA DETECTIONTherapy zones Values Nominal value "As shipped"valueSlow VT detectionzoneSlow VT ON-Slow VT OFF Slow VT OFF Slow VT OFFVT detection zone VT ON-VT OFF VT OFF VT OFFFast VT / VF detec-tion zoneFast VT+VF ON-VF ON VF ON VF ONSlow VT rate (lowerlimit) (ppm)From 100 to 200 by steps of 5 190 190VT rate (lower limit)(ppm)130-135-140-145-150-155-160-165-170-175-180-185-190-195-200-210-220-230190 190VF rate (lower limit)(ppm)150-155-160-165-170-175-180-185-190-195-200-210-220-230-240190 190Fast VT rate (upperlimit) (ppm)155-160-165-170-175-180-185-190-195-200-210-220-230-240-255190 190Slow VT persistence(cycles)4-6-8-12-16-20-30-50-100-200 12 12VT persistence (cy-cles)4-6-8-12-16-20-30-50-100-200 12 12VF persistence (cy-cles)From 4 to 20 by steps of 1 6 6Detection criteria Values Nominal value "As shipped"valueSlow VT and VT de-tection criteriaRate Only-Stability-Stability+-Stability/Acc-Stability+/Acc-PARAD-PARAD+PARAD PARADFast VT detectioncriteriaRate+Stability-Rate Only Rate+Stability Rate+StabilityMajority: (X/Y), Y(cycles)8-12-16 8 8Majority: (X/Y), X (%) 65-70-75-80-90-95-100 75 75Window of RR stabil-ity for Slow VT andVT (ms)30-45-65-80-95-110-125 65 65Window of RR stabil-ity for fast VT (ms)30-45-65 30 30Acceleration (%) 6-13-19-25-31-38-44-50 25 25Long cycle persis-tence extension (cy-cles)From 0 to 16 by steps of 1 10 10Long cycle gap (ms) 15-30-45-65-80-95-110-125-140-155-170-190-205170 170Atrial monitoring Yes-No Yes Yes21.2.21. PROGRAMMABLE PARAMETERS62 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
VENTRICULAR TACHYARRHYTHMIA THERAPIESCommon parame-tersValues Nominal value "As shipped"valueEnable ATP therapy Yes-No No NoEnable shock thera-pyYes-No Yes NoATP pacing chamber Right-R+L-L+R Right RightPolarity alternation(42J)Yes-No No NoAtrial coil (SVC) pre-sentYes-No YesActive case Yes-No YesShock configuration(+ --> -)Case to RV-SVC to RV-Case + SVC to RV-RV to Case-RV to SVC-RV to Case + SVCRV to Case +SVCRV to Case +SVCSVC exclusion(shock < 15J)Yes-No No NoTherapy parameters in slow VT zoneATP 1 program Values Nominal value "As shipped"valueATP program OFF-Burst-Burst+Scan-Ramp-Ramp+ScanOFF OFFNumber of se-quences1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 3 3Cycles in first se-quence1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 8 8Cycles added persequence0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 0 0Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 80 80Ramp decrement(per cycle) (ms)0-4-8-12-16-20-30-40-50-60 0 0Scan decrement (persequence) (ms)0-4-8-12-16-20-30-40-50-60 8 8Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 2 2Minimum cyclelength (ms)95-110-125-140-155-170-190-205-220-235-250-265-280-295-310220 22021.3.21.3.1.21. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 63
ATP 2 program Values Nominal value "As shipped"valueATP program OFF-Burst-Burst+Scan-Ramp-Ramp+ScanOFF OFFNumber of se-quences1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 3 3Cycles in first se-quence1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 6 6Cycles added persequence0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 1 1Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 85 85Ramp decrement(per cycle) (ms)0-4-8-12-16-20-30-40-50-60 8 8Scan decrement (persequence) (ms)0-4-8-12-16-20-30-40-50-60 0 0Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 2 2Minimum cyclelength (ms)95-110-125-140-155-170-190-205-220-235-250-265-280-295-310220 220Shock program Values Nominal value "As shipped"valueShock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFShock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFNumber of Max.Shock (42 J)OFF-1-2-3-4 OFF OFF21. PROGRAMMABLE PARAMETERS64 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
Therapy parameters in VT zoneATP 1 program Values Nominal value "As shipped"valueATP program OFF-Burst-Burst+Scan-Ramp-Ramp+ScanBurst+Scan Burst+ScanNumber of se-quences1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 3 3Cycles in first se-quence1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 8 8Cycles added persequence0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 0 0Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 80 80Ramp decrement(per cycle) (ms)0-4-8-12-16-20-30-40-50-60 0 0Scan decrement (persequence) (ms)0-4-8-12-16-20-30-40-50-60 8 8Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 0.5 2Minimum cyclelength (ms)95-110-125-140-155-170-190-205-220-235-250-265-280-295-310220 220ATP 2 program Values Nominal value "As shipped"valueATP program OFF-Burst-Burst+Scan-Ramp-Ramp+ScanRamp RampNumber of se-quences1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 3 3Cycles in first se-quence1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 6 6Cycles added persequence0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 1 1Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 85 85Ramp decrement(per cycle) (ms)0-4-8-12-16-20-30-40-50-60 8 8Scan decrement (persequence) (ms)0-4-8-12-16-20-30-40-50-60 0 0Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 0.5 2Minimum cyclelength (ms)95-110-125-140-155-170-190-205-220-235-250-265-280-295-310220 22021.3.2.21. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 65
Shock program Values Nominal value "As shipped"valueShock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFShock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFNumber of Max.Shock (42 J)OFF-1-2-3-4 4 4Therapy parameters in fast VT / VF zoneATP 1 program Values Nominal value "As shipped"valueATP program OFF-Burst-Burst+Scan-Ramp-Ramp+ScanBurst BurstNumber of se-quences1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 1 1Cycles in first se-quence1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 8 8Cycles added persequence0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 0 0Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 80 80Ramp decrement(per cycle) (ms)0-4-8-12-16-20-30-40-50-60 0 0Scan decrement (persequence) (ms)0-4-8-12-16-20-30-40-50-60 0 0Time limit 10s-20s-30s-1min-1.5min-2min 30s 30sMinimum cyclelength (ms)95-110-125-140-155-170-190-205-220-235-250-265-280-295-310205 205Shock program Values Nominal value "As shipped"valueShock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFShock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-910-12-14-16-18-20-22-24-26-28-30-32-34-42OFF OFFNumber of Max.Shock (42 J)1-2-3-4 4 4REMOTE ALERTS AND WARNINGSThe device routinely performs security self-checks and technical measurements to ensuresystem integrity. When system integrity is found to be at risk outside a follow-up, alerts arestored in the device memory. When system integrity is found to be at risk during a follow-21.3.3.21.4.21. PROGRAMMABLE PARAMETERS66 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
up, the information is managed by a warning (pop-up message) to immediately notify theuser. For example, the following types of events can trigger a warning or an alert: technicalproblem during a shock, pacing lead impedance or coil impedance measurements out-of-range, battery depletion, etc. The Remote tab presents an overview of all the alerts managedby the device.General parameters Values Nominal value "As shipped"valueRF communication (1) ON-OFF ON OFFAlerts (1) ON-OFF ON ON(1) RF and Remote alerts are turned on automatically if Shocks are programmed ON.When Alerts are programmed "On", the following System Alerts are automatically activated:― “Battery depletion – RRT”― “Device reset”― “Excessive charge time (>25s)”― “System integrity”Lead Alerts Values Nominal value "As shipped"valueAbnormal A lead im-pedanceON-OFF ON ONAbnormal A lead lowlimit (Ohm)200-250-300-350-400-450-500 200 200Abnormal A leadhigh limit (Ohm)1500-1750-2000-2500-3000 3000 3000Abnormal RV leadimpedanceON-OFF ON ONAbnormal RV leadlow limit (Ohm)200-250-300-350-400-450-500 200 200Abnormal RV leadhigh limit (Ohm)1500-1750-2000-2500-3000 3000 3000Abnormal LV leadimpedanceON-OFF ON ONAbnormal LV leadlow limit (Ohm)200-250-300-350-400-450-500 200 200Abnormal LV leadhigh limit (Ohm)1500-1750-2000-2500-3000 3000 3000Abnormal RV coil im-pedanceON-OFF ON ONAbnormal SVC coilimpedanceON-OFF ON ONAbnormal Shock im-pedance (1) ON-OFF ON ON(1) Normal impedance range [20 Ohm-200 Ohm]21. PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 67
Clinical status Values Nominal value "As shipped"valueV oversensing ON-OFF OFF OFFHigh AT/AF burden ON-OFF OFF OFFAT/AF limit (on 24h)(h)0.5-1-3-6-12-24 6 6Fast V Rate duringAT/AFON-OFF OFF OFFFast V Rate limit(ppm)80-90-100-110-120 100 100Fast V Duration limit(h)0.5-1-3-6-12-24 1 1Limited % of V pac-ing in CRTON-OFF OFF OFFLimited % of V pac-ing (%)50-70-80-85-90-95 80 80Therapy informa-tionValues Nominal value "As shipped"valueShock disabled ON-OFF ON ONShocks delivered OFF-All shocks-Inefficient shock-Inefficient max shockAll shocks All shocksATP delivered ON-OFF OFF OFF21. PROGRAMMABLE PARAMETERS68 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
22. NON PROGRAMMABLE PARAMETERSInterval Values Nominal value "As shipped"valueCommitted period 95 ms (± 5 ms)Atrial refractory pe-riodsValues Nominal value "As shipped"valuePost atrial sensing 47 ms (± 16 ms)Post atrial pacing 109 ms (± 4 ms)Ventricular refrac-tory periodsValues Nominal value "As shipped"valuePost ventricularsensing95 ms (± 16 ms)Post ventricular pac-ing220 ms (± 4 ms)Post atrial pacing(blanking)16 ms (± 3 ms)Therapies Values Nominal value "As shipped"valueWaveform (1) Constant tilt (50% - 50%)Stored energy for theMax. shock42 JPacing amplitudeduring ATP therapies7 V (Actual value at 300 ms: 5.3 V )Anti-PMT protection Termin(1) The device has 50% tilt in each phase thus delivers 94% of stored energy. Each phase is limitedto 10 ms duration.22. NON PROGRAMMABLE PARAMETERSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 69
23. LIMITED WARRANTYThe PLATINIUM implantable cardioverter defibrillator is the result of highly advancedresearch and all components have been selected after exhaustive testing.The terms of the limited warranty are available upon request from your Sorin representative.23. LIMITED WARRANTY70 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
24. PATENTSThe PLATINIUM model described in this manual is covered by the following US patents:5 713 928, 5 741 315, 5 776 164, 5 776 165, 5 818 703, 5 836 980, 5 868 793, 5 891 170,5 891 184, 5 899 931, 5 931 856, 5 935 153, 5 954 660, 5 978 708, 6 181 968, 6 230 058,6 236 111, 6 251 703, 6 256 206, 6 307 261, 6 337 996, 6 397 105, 6 408 209, 6 487 451, 6487 452, 6 505 068, 6 532 238, 6 556 866, 6 604 002, 6 622 039, 6 625 491, 6 711 441, 6738 665, 6 830 548, 6 889 080, 6 898 845, 6 912 421, 6 937 898, 6 975 905, 7 065 402, 7072 716, 7 076 297, 7 113 826, 7 142 924, 7 164 946, 7 251 526, 7 366 566, 7 400 921, 7400 922, 7 953 483, 8 064 992, 8 043 225, 7 792 582, 8 798 748, 7 890 168, 8 195 293, 7966 068, 8 768 464, 8 874 209, 8 554 313, 8 214 036, 8 233 981, 8 554 319, 7 966 065, 8253 279, 8 874 210, 8 219 193, 8 391 976, 8 855 764, 8 359 096, 8 494 629, 8 359 091, 8489 188, 8 712 526, 8 862 230, 8 641 436, 8 718 765, 8 798 771, 8 868 170, 8 678 843 , 8694 098, 8 938 286, 8 874 212.24. PATENTSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 71
25. EXPLANATION OF SYMBOLSList of applicable symbols for High-voltage Sorin devices.General sym-bolsExplanation of symbolsUse byDate of manufactureManufacturerCatalogue numberSerial numberImplantable device un-coatedPackage contentSterile package contentOpen hereDo not use if the packageis damagedDo not reuseDo not resterilizeSterilised using ethyleneoxideNon sterileTemperature limitationGeneral sym-bolsExplanation of symbolsScrewdriverModeBasic rateConsult instructions foruseInstructions for use in theCD-ROMThis icon is used to callyour attention to a partic-ularly important point.This icon alerts you to ahazard that may result inequipment damage orpersonal injury.Carefully read the in-structions provided withthis icon.Eucomed / AdvamedCode of Ethical BusinessPracticeDefibrillatorsymbolsExplanation of symbolsICD (CRT-D, RA, RV, LV)ICD (dual chamber, RA, RV)ICD (single chamber, RV)SonR, CRT-D DF-1 connec-torsCRT-D DF-1 connectors25. EXPLANATION OF SYMBOLS72 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A
DefibrillatorsymbolsExplanation of symbolsDR DF-1 connectorsVR DF-1 connectorsSonR, Tri-V DF-1 connec-torsSonR, CRT-D DF-1 connec-torsCRT-D DF-1 connectorsDR DF-1 connectorsVR DF-1 connectorsSonR, CRT-D DF4 (IS-1)connectorsCRT-D DF4 (IS-1) connec-torsDefibrillatorsymbolsExplanation of symbolsDR DF4 (IS-1) connectorsVR DF4 connectorShocksATPATP Anti-tachycardia pacing,RV, LVATPATP Anti-tachycardia pacing,RVHigh voltageReady for wireless interroga-tion and programming by Or-chestra Plus programmerequipped with ORCHESTRAPLUS LINK accessoryDF-1 defibrillating connectorinsulating plugLast revision date of this implant manual: 2016-0625. EXPLANATION OF SYMBOLSSORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 73
Sorin Group Italia S.r.l.Via Crescentino S.N.13040 Saluggia (VC)ItalyTel: +39 0161 487095Fax: +39 0161 487524manufac tured in ita ly bywww.l iva n ova.com2016-06u906aSorin CRM USA, Inc. 14401 West 65th WayArvada, CO 80004USATel: 877.663.7674dis trib u ted byCAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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