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sorin Intensia SonR CRT-D 184, Implant Manual

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sorin Intensia SonR CRT-D 184 Implant Manual Download Page 31

 12.  HOW SUPPLIED

 12. HOW SUPPLIED

12.1.

STERILITY

The INTENSIA defibrillators are supplied one per package in a sterile package.

12.2.

WARRANTY AND REPLACEMENT POLICY

Sorin warrants its defibrillators. Refer to the section "Warranty" for additional information. 
Please see the following labelling sections for information concerning the performance of 
this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.

SORIN – INTENSIA SonR CRT-D 184 – U150A

29

Summary of Contents for Intensia SonR CRT-D 184

Page 1: ...Implant manual Implantable cardioverter defibrillator SonR CRT D model 184...

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Page 5: ...Conformance to standards 23 10 Physician guidelines 26 10 1 Physician training 26 10 2 Directions for use 26 10 3 Maintaining device quality 26 10 4 V V Programming Recommendation 27 11 Patient infor...

Page 6: ...ime RRT 44 17 4 Explantation 44 17 5 Defibrillator identification 45 18 Supplemental Information 46 18 1 Adverse events in the SafeR AAI DDD study 46 18 2 SafeR AAI DDD clinical study 47 19 Physical c...

Page 7: ...ccelerometer to allow adaptation of pacing to suit the patient s activity INTENSIA SonR CRT D 184 is also equipped with the RF wireless technology which enables to remotely monitor the patients who ha...

Page 8: ...tion for automated treatment of life threatening arrhythmias The device is also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients w...

Page 9: ...ion digitalis intoxication drowning electrocution electrolyte imbalance hypoxia sepsis or unstable ischemic episodes who present incessant tachyarrhythmia who have an internal pacemaker whose primary...

Page 10: ...vailable Electrical Isolation Do not permit the patient to contact grounded equipment that could produce hazardous leakage current Ensuing arrhythmia induction could result in the patient s death Disa...

Page 11: ...2 Before procedure disable ATP and shock therapies 3 During the procedure keep the electrocautery device as far as possible from the cardiac defibrillator Set it at minimum intensity Use it briefly 4...

Page 12: ...plant the device after this date because the battery may have reduced longevity and sterility may be affected It should be returned to Sorin If Package is damaged Do not use the device or accessories...

Page 13: ...either a conventional atrial lead without SonR capability or a SonR atrial lead bipolar pacing sensing and SonR capability IS 1 refers to the international standard whereby leads and generators from d...

Page 14: ...e delivery of energy to the heart Place the sutures well outside the coil of the patch lead or in the area between the coils to avoid possible coil fracture If countershock is unsuccessful using exter...

Page 15: ...IO CRT D are applicable to INTENSIA SonR CRT D 184 The table below summarizes the adverse events observed for the CRT D system No deaths were related to the system Event of Patients of Patients of Eve...

Page 16: ...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 Inappropri...

Page 17: ...5 ADVERSE EVENTS Fear of premature battery depletion Fear of shocking while conscious Fear that shocking capability may be lost Imagined shocking phantom shock SORIN INTENSIA SonR CRT D 184 U150A 15...

Page 18: ...of life for CRT D patients than for control patients System complication free rate 67 at six months 6 1 2 Methods Patients were New York Heart Association class III or IV and had one or more indicati...

Page 19: ...est group n 91 11 84 3 90 3 50 26 3 13 41 4 28 6 18 27 67 1 57 Absolute difference between test and control groups change in QOL score over 6 months Baseline Mean SD range 6 month Mean SD range Differ...

Page 20: ...nd OVATIO CRT D 6750 values 0 to 63 ms in steps of 8 ms The graph below shows the programmed V V settings at randomization by percentage of patients programmed to each combination of Synchronous BiV p...

Page 21: ...remaining 174 patients 154 89 were tested per the V V optimization protocol One hundred forty nine 149 of the 154 patients who were tested per the V V optimization protocol were programmed per the rec...

Page 22: ...tients Antiarrhythmic drug therapy If the patient is being treated with antiarrhythmic or cardiac drugs the patient should be on a maintenance drug dose rather than a loading dose at the time of ICD i...

Page 23: ...here 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 Mo...

Page 24: ...ng points in counselling the patient about this device Persons administering CPR may experience tingling on the patient s body surface when the patient s ICD system delivers a shock Advise patients to...

Page 25: ...ic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields 10 MHz 300 GHz EN 301 489 1 v1 8 1 EN 301 489 27 v1 1 1 Electromagnetic compatibility and Ra...

Page 26: ...used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference that m...

Page 27: ...susceptible de compromettre le fonctionnement du dispositif Conform ment la r glementation d Industrie Canada le pr sent metteur radio peut fonctionner avec une antenne d un type et d un gain maximal...

Page 28: ...mplication rates Established patient follow up Maintenance of competence 10 ICD and CRT D procedures per year 20 patients per year in follow up 1 Please consult full text of both publications for deta...

Page 29: ...to 122 F 50 C as an electrical reset condition may occur Use Before date has expired because this can adversely affect pulse generator longevity or sterility 10 4 V V PROGRAMMING RECOMMENDATION It is...

Page 30: ...e outer storage package Additional copies can be obtained by contacting your Sorin representative or on the Sorin s web site http www sorin com This information should be given to each patient with th...

Page 31: ...ANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators Refer to the section Warranty for additional information Please see the following labelling sections for information concerning the perfor...

Page 32: ...hing function are available INTENSIA SonR CRT D 184 enables an adjustment of the interventricular delay and provides the possibility of adapting pacing to each ventricle The ICD is intended to resynch...

Page 33: ...ctor head has three ports Atrial SonR port performs atrial bipolar pace sense if a conventional IS 1 lead is connected LV IS 1 port performs left ventricular bipolar pace RV DF 4 port performs right v...

Page 34: ...ckaging contains a defibrillator and one screwdriver The non sterile items contained in the outer storage package are the implant manual the ICD Registration Form and its envelope the patient booklet...

Page 35: ...ated before implantation Verify all shock therapies are disabled in order to avoid accidental discharge during implantation It is not advisable to program the Smoothing function before implantation si...

Page 36: ...ramming When active case and SVC are both programmed to Yes the shock configuration can 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 RV to Ca...

Page 37: ...ying that the lead port is not filled with any obstacle 4 Insert the screwdriver into the pre inserted screw socket of the appropriate port in order to allow excess air to bleed out and to make the in...

Page 38: ...n the can and the heart Suture the casing connector to the muscle using the hole provided for this purpose in order to avoid potential migration of the device into the pectoral muscle 14 12 TESTS AND...

Page 39: ...PMT Smoothing Rate Response When the magnet is removed the sensor rate is forced to the basic rate arrhythmia detection algorithms and sequential therapies are reinitialized therapies start with the l...

Page 40: ...ial sensitivity setting of 0 2 mV compliance to the Cenelec standard 45502 2 2 is met for a maximum test signal amplitude of 8 V for the frequency of 60 MHz 0 4 mV complies with the standard for the w...

Page 41: ...yarrhythmia onset Searching for a long cycle P And R based Arrhythmia Detection PARAD Additional arrhythmia classification criterion to improve identification of atrial fibrillation and avoid inapprop...

Page 42: ...te ventricular inhibition if crosstalk occurs Protection against noise Allows the distinction between ventricular noise and ventricular fibrillation If the device senses ventricular noise the ventricu...

Page 43: ...clinic The data is transmitted from the implant and the SMARTVIEW monitor a small transmitter placed in the patient home Implant data are first transmitted to the SMARTVIEW monitor via RF Data are th...

Page 44: ...ased on the degree of severity for the patient 16 8 4 User website On the website the physician is able to consult and schedule the remote follow ups of their patient configure additional ways of bein...

Page 45: ...e reset the magnet rate is equal to 87 bpm it will be updated within the next 24 hours Refer to the online help for a description of displayed warning and the necessity to contact Sorin for an evaluat...

Page 46: ...FF one 42 J shock every 2 weeks Once the Recommended Replacement Time RRT point has been reached the device operates normally except that the charge time increases Under normal conditions and without...

Page 47: ...y shock 17 5 DEFIBRILLATOR IDENTIFICATION The defibrillator can be interrogated and programmed via telemetry using the programming head interfaced with the Sorin dedicated programmer Position the prog...

Page 48: ...er of patients of patients Number of events Events per device year a Deaths 0 0 0 0 Explants 0 0 0 0 Serious pacemaker related events outside the use of SafeR AAI DDD 0 0 0 0 Non serious pacemaker rel...

Page 49: ...mber rate responsive pacemaker with SafeR AAI DDD mode A variety of marketed atrial and ventricular pacing leads were used The pacemaker was programmed and interrogated via bi directional telemetry us...

Page 50: ...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 AV block 1 Pioger G Jauvert G Nitzsch R Pozzan J Laur...

Page 51: ...rface area of casing 76 cm2 Connector Atrium SonR Right ventricle DF 4 Left ventricle IS 1 19 1 MATERIALS USED Active surface area of casing 99 pure titanium Connectors Polyurethane and silicone elast...

Page 52: ...gies maximum voltages and delivered energies at 37 C 50 ohm load for the minimum low mean and maximum programmed energy values is as follows Stored energy J 0 5 10 20 34 42 V1 Volt 75 341 483 631 702...

Page 53: ...R ON 6 0 years Biventricular pacing in DDD mode 1 in atrium 100 in both ventricles 500 ohm 3 5 V 0 35 ms 60 bpm one 42 J shock per quarter sensors OFF 4 2 years Biventricular pacing in DDD mode 15 in...

Page 54: ...5 95 100 110 115 125 135 140 150 155 165 170 180 190 195 205 210 220 225 235 250 19 ms Exercise 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 2...

Page 55: ...3 ms 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 pulse delivered amplitudes u...

Page 56: ...nsed Offset ms 0 10 15 25 30 40 45 55 65 70 80 85 95 100 110 115 125 1 ms A amplitude V 1 1 5 2 2 5 3 3 5 4 4 5 5 6 20 A pulse width ms 0 12 0 25 0 35 0 5 0 6 0 75 0 85 1 10 RV amplitude V 1 1 5 2 2 5...

Page 57: ...VT VF detection zone Fast VT VF ON VF ON Slow VT rate lower limit bpm From 100 to 200 by steps of 5 190 VT rate lower limit bpm 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 210 220 230...

Page 58: ...celeration 6 13 19 25 31 38 44 50 Long cycle persistence extension cycles From 0 to 16 by steps of 1 10 Long cycle gap ms 15 30 45 65 80 95 110 125 140 155 170 190 205 Atrial monitoring Yes No 21 3 VE...

Page 59: ...m Values ATP program OFF Burst Burst Scan Ramp Ramp Scan Number of sequences 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles in first sequence 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles added per sequence...

Page 60: ...Values ATP program OFF Burst Burst Scan Ramp Ramp Scan Number of sequences 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles in first sequence 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles added per sequence 0...

Page 61: ...of Max Shock 42 J 1 2 3 4 21 4 REMOTE ALERTS AND WARNINGS The device routinely performs security self checks and technical measurements to ensure system integrity When system integrity is found to be...

Page 62: ...0 Abnormal LV lead high limit Ohm 1500 1750 2000 2500 3000 Abnormal RV coil impedance ON OFF Abnormal SVC coil impedance ON OFF Abnormal Shock impedance 1 ON OFF 1 Normal impedance range 20 Ohm 200 Oh...

Page 63: ...s Post ventricular pacing 220 ms 4 ms Post atrial pacing blanking 16 ms 3 ms Tachycardia criteria Values Window of PR association 63 ms 1 ms Therapies Values Waveform 1 Constant tilt 50 50 Stored ener...

Page 64: ...erter defibrillator must be implanted prior to the use before date indicated on the packaging 4 The limited guarantee only applies to suspect devices returned to the manufacturer carefully packed and...

Page 65: ...iod starting from the implantation date Sorin is committed to replacing free of charge the explanted device by a Sorin device with equivalent features or issuing a replacement credit equal to the purc...

Page 66: ...15 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 1...

Page 67: ...e oxide Temperature limitation High voltage Consult instruction for use This icon is used to call your attention to a particularly important point This icon alerts you to a hazard that may result in e...

Page 68: ...CRM USA Inc Via Crescentino s n 14401 West 65th Way 13040 Saluggia VC Italy Arvada CO 80004 USA Tel 39 0161 487095 Tel 877 663 7674 Facsimile 39 0161 487524 www sorin com 2013 09 U150A CAUTION FEDERA...

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