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sorin Intensia DR 154, Руководство по имплантации

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 6.  CLINICAL STUDIES

Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on 
2nd degree AV block, inappropriate classification of a PAC, disagreement between markers 
and recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave in a 
refractory   period,   and   disagreement   in   the   statistics   for   switches   to   DDD.   No   patient 
symptoms were associated with these events. 

SORIN – INTENSIA DR 154 – U152A

21

Содержание Intensia DR 154

Страница 1: ...Implant manual Implantable cardioverter defibrillator DR model 154...

Страница 2: ...blank...

Страница 3: ......

Страница 4: ...blank...

Страница 5: ...atient counselling information 24 9 Conformance to standards 25 10 Physician guidelines 28 10 1 Physician training 28 10 2 Directions for use 28 10 3 Maintaining device quality 28 11 Patient informati...

Страница 6: ...olter Function 44 17 3 Recommended Replacement Time RRT 45 17 4 Explantation 45 17 5 Defibrillator identification 46 18 Physical characteristics 47 18 1 Materials used 47 19 Electrical characteristics...

Страница 7: ...NSIA DR 154 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home INTENSIA DR 154 provides high energy...

Страница 8: ...f the following situations Survival of at least one episode of cardiac arrest manifested by the loss of consciousness due to ventricular tachyarrhythmia Recurrent poorly tolerated sustained ventricula...

Страница 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...

Страница 10: ...Shock Therapy to OFF during surgical implant and explant or post mortem procedures The device can deliver a serious high energy shock should accidental contact be made with the defibrillation electro...

Страница 11: ...he cardiac defibrillator Set it at minimum intensity Use it briefly 4 After the procedure check for proper implant function The device should never be exposed directly to the diathermy source External...

Страница 12: ...the device or accessories if the packaging is wet punctured opened or damaged because the integrity of the sterile packaging may be compromised Return the device to the manufacturer Device Storage Sto...

Страница 13: ...to the lead body tie it too tightly or otherwise create excessive strain at the insertion site as this may damage the lead Use the lead stabilizer to secure the lead lateral to the venous entry site...

Страница 14: ...nal paddles adjust the external paddle position e g anterior lateral to anterior posterior and be sure that the external paddle is not positioned over the patch Do not fold alter or remove any portion...

Страница 15: ...t were treated with surgery or with external defibrillation of a ventricular cardiac event Observations are defined as symptomatic or asymptomatic clinical events with potential adverse device effects...

Страница 16: ...est 2 5 3 2 10 5 Ventricular oversensing 3 7 9 3 15 7 A patient can have more than one observation There were 228 7 device months in this study These observations would not have happened with the curr...

Страница 17: ...ious non pacemaker related events 8 17 8 8 1 7 a 4 74 device years Non serious events due to the use of SafeR 2 AAI DDD included delay in switching on 2nd degree AV block inappropriate classification...

Страница 18: ...y available defibrillator lead outside the U S Methods Investigators selected patients who survived at least one episode of cardiac arrest manifested by loss of consciousness presumably due to a ventr...

Страница 19: ...Upper 95 CI Europe 20 0 77 0 17 0 04 0 69 0 84 Small Centers 9 0 79 0 18 0 06 0 67 0 91 Large Centers 11 0 75 0 15 0 05 0 66 0 84 Males 17 0 77 0 16 0 04 0 70 0 85 Females 3 0 73 0 22 0 13 0 47 0 98...

Страница 20: ...study 6 2 SAFER AAI DDD STUDY SafeR AAI DDD mode in INTENSIA 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...

Страница 21: ...le 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 Effectiven...

Страница 22: ...block brady tachy syndrome 6 and brady tachy syndrome sinus node disease 5 Adverse events Clinical study of the SafeR AAI DDD included 45 Symphony 2550 devices implanted in 45 patients No serious adve...

Страница 23: ...V block inappropriate classification of a PAC disagreement between markers and recorded EGM atrial pacing above the maximum rate recycling on an R wave in a refractory period and disagreement in the s...

Страница 24: ...h patients Antiarrhythmic drug therapy If the patient is being treated with antiarrhythmic or cardiac drugs the patient should be on a maintenance drug dose rather than a loading dose at the time of I...

Страница 25: ...ce 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 Patient...

Страница 26: ...lowing 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 patient...

Страница 27: ...tronic 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 an...

Страница 28: ...ers 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 th...

Страница 29: ...est 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 max...

Страница 30: ...e screen on the Sorin dedicated programmer Paper copies of Online Help can be obtained by contacting your Sorin representative 10 3 MAINTAINING DEVICE QUALITY This device is FOR SINGLE USE ONLY Do not...

Страница 31: ...n the 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 wit...

Страница 32: ...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 pe...

Страница 33: ...utomatic AV delay algorithm as well as a mode switching function are available INTENSIA DR 154 offers tiered therapy Therapies can be programmed independently in each zone in the Slow VT and VT zones...

Страница 34: ...with the IS 1 standard and defibrillation ports is compatible with the DF 4 standard Distal lead terminal connections are secured with set screws accessed via self sealing silicone plugs All lead con...

Страница 35: ...e packaging 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 book...

Страница 36: ...to verify the defibrillator can be interrogated before implantation Verify all shock therapies are disabled in order to avoid accidental discharge during implantation It is not advisable to program th...

Страница 37: ...LANT Pacing and sensing thresholds should be measured at implant Pacing thresholds Acute thresholds should be lower than 1 V or 2 mA for a 0 35 ms pulse width both in the ventricle and in the atrium S...

Страница 38: ...he lead pin all the way into the port check that the pin protrudes beyond the distal insert 6 Tighten check the tightness and ensure the lead pin still protrudes beyond the distal insert and did not m...

Страница 39: ...g the hole provided for this purpose in order to avoid potential migration of the device into the pectoral muscle 14 12 TESTS AND PROGRAMMING During the implant testing procedure it is recommended tha...

Страница 40: ...ention Mode Switch Anti PMT Smoothing Rate Response When the magnet is removed the sensor rate is forced to the basic rate arrhythmia detection algorithms and sequential therapies are reinitialized th...

Страница 41: ...atrial 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 t...

Страница 42: ...ventricular tachyarrhythmia onset Searching for a long cycle P And R based Arrhythmia Detection PARAD Additional arrhythmia classification criterion to improve identification of atrial fibrillation an...

Страница 43: ...he committed period prevents inappropriate ventricular inhibition if crosstalk occurs Protection against noise Allows the distinction between ventricular noise and ventricular fibrillation If the devi...

Страница 44: ...16 7 1 SMARTVIEW Monitor The SMARTVIEW monitor is a small device equipped with an RF transmission module to communicate with the implant and a modem to export data through the internet The SMARTVIEW...

Страница 45: ...follow ups of their patient configure additional ways of being notified of alerts for instance by SMS fax or e mail consult print and export patient reports 16 7 5 Alert system The following set of a...

Страница 46: ...a device 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...

Страница 47: ...at the charge time increases Under normal conditions and without programmer use the charge times are as follows Shock energy Charge time sec BOS 3 42 J 10 2 RTT 42 J 13 3 1 Recommended Replacement Tim...

Страница 48: ...rogramming head interfaced with the Sorin dedicated programmer Position the programming head over the telemetry antenna located in the upper part of the device in order to communicate effectively via...

Страница 49: ...8 6 cm3 Active surface area of casing 76 cm2 Connector Atrium IS 1 Ventricle DF 4 18 1 MATERIALS USED Active surface area of casing 99 pure titanium Connectors Polyurethane and silicone elastomer Medi...

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

Страница 51: ...r G sensor ON 8 7 years Pacing in DDD mode 15 in atrium 1 in ventricle 500 ohm 3 5 V 0 35 ms 60 bpm one 42 J shock per quarter sensor OFF 7 8 years Pacing in DDD mode 15 in atrium 15 in ventricle 500...

Страница 52: ...18 ms Rest 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 Exercise AV delay ms 30 40 45 55 65 70 80 85 95 100 110 115 125 135...

Страница 53: ...ar signal of 2 13 ms 2 The correlation between the programmed amplitudes the stored amplitudes and the mid pulse delivered amplitudes under a 500 ohm load are given in the following table Programmed a...

Страница 54: ...0 5 0 6 0 75 0 85 1 10 V amplitude V 1 1 5 2 2 5 3 3 5 4 4 5 5 6 20 V pulse width ms 0 12 0 25 0 35 0 5 0 6 0 75 0 85 1 10 Refractory periods Values Atrial refractory period post ventricular sensing...

Страница 55: ...0 30 50 100 200 VT persistence cycles 4 6 8 12 16 20 30 50 100 200 VF persistence cycles From 4 to 20 by steps of 1 6 1 The Slow VT zone should be programmed ON only if the VT zone is programmed ON De...

Страница 56: ...in slow VT zone ATP 1 program 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 1...

Страница 57: ...3 1 5 2 2 5 3 3 5 4 5 6 7 8 9 10 12 14 16 18 20 22 24 26 28 30 32 34 42 Shock 2 J OFF 0 5 0 8 1 1 3 1 5 2 2 5 3 3 5 4 5 6 7 8 9 10 12 14 16 18 20 22 24 26 28 30 32 34 42 Number of Max Shock 42 J OFF 1...

Страница 58: ...2 2 5 3 3 5 4 5 6 7 8 9 10 12 14 16 18 20 22 24 26 28 30 32 34 42 Shock 2 J OFF 0 5 0 8 1 1 3 1 5 2 2 5 3 3 5 4 5 6 7 8 9 10 12 14 16 18 20 22 24 26 28 30 32 34 42 Number of Max Shock 42 J OFF 1 2 3...

Страница 59: ...ock pacing lead impedance or coil impedance measurements out of range battery depletion etc The Remote tab presents an overview of all the alerts managed by the device General parameters Values RF com...

Страница 60: ...AF limit on 24h h 0 5 1 3 6 12 24 Fast V Rate during AT AF ON OFF Fast V Rate limit bpm 80 90 100 110 120 Fast V Duration limit h 0 5 1 3 6 12 24 Therapy information Values Shock disabled ON OFF Shoc...

Страница 61: ...16 ms 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...

Страница 62: ...dioverter 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...

Страница 63: ...period 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...

Страница 64: ...41 315 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 3...

Страница 65: ...ng ethylene 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 r...

Страница 66: ...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 U152A CAUTION FEDERA...

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