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St. Jude Medical Quadra Assura, Руководство пользователя

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St. Jude Medical Quadra Assura Скачать руководство пользователя страница 19

 

17 

 
 

Potential Adverse Events

Potential Adverse Events

Potential Adverse Events

Potential Adverse Events    

Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to 
the following: 

 

Acceleration of arrhythmias (caused by device) 

 

Air embolism 

 

Allergic reaction 

 

Bleeding 

 

Cardiac tamponade 

 

Chronic nerve damage 

 

Death 

 

Erosion 

 

Exacerbation of heart failure 

 

Excessive fibrotic tissue growth 

 

Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) 

 

Extrusion 

 

Fluid accumulation 

 

Formation of hematomas or cysts 

 

Inappropriate shocks 

Содержание Quadra Assura

Страница 1: ...rillator Fortify Assura Tiered therapy Cardioverter Defibrillator Quadra Assura Cardiac Resynchronization Device Tiered therapy Cardioverter Defibrillator Unify Assura Cardiac Resynchronization Device Tiered therapy Cardioverter Defibrillator ...

Страница 2: ... cause cancer or birth defects or other reproductive harm ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies CAUTION Federal USA law restricts this device to sale by or on the order of a physician 2012 St Jude Medical Cardiac Rhythm Management Division All Rights Reserved U...

Страница 3: ...l Number Model Number Description Description Description Description Connector Type Connector Type Connector Type Connector Type Delivered Delivered Delivered Delivered Energy Energy Energy Energy approx approx approx approx Ellipse VR CD1275 36 Single chamber ICD with RF telemetry DF 1 IS 1 36 J Ellipse VR CD1275 36Q Single chamber ICD with RF telemetry DF4 LLHH 36 J Fortify Assura VR CD1257 40 ...

Страница 4: ...r descriptions Fortify Assura VR CD1257 40Q Single chamber ICD with RF telemetry DF4 LLHH 40 J Ellipse VR CD1311 36 Single chamber ICD with RF telemetry DF 1 IS 1 36 J Ellipse VR CD1311 36Q Single chamber ICD with RF telemetry DF4 LLHH 36 J ...

Страница 5: ...gy Energy approx approx approx approx Ellipse DR CD2275 36 Dual chamber ICD with RF telemetry DF 1 IS 1 36 J Ellipse DR CD2275 36Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 36 J Fortify Assura DR CD2257 40 Dual chamber ICD with RF telemetry DF 1 IS 1 40 J Fortify Assura DR CD2257 40Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 40 J Ellipse DR CD2311 36 Dual chamber ICD with RF telemetr...

Страница 6: ...x approx approx Quadra Assura CD3265 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40 J Quadra Assura CD3265 40Q CRT D with RF telemetry DF4 LLHH IS4 LLLL IS 1 40 J Unify Assura CD3257 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40 J Unify Assura CD3257 40Q CRT D with RF telemetry DF4 LLHH IS4 LLLL IS 1 40 J The pulse generator along with compatible commercially available leads constitutes the i...

Страница 7: ...ge RV lead SJ4 LLHH is equivalent to DF4 LLHH SJ4 and DF4 connectors comply with ISO 27186 2010 E SJ4 LLLL is equivalent to IS4 LLLL SJ4 and IS4 connectors comply with ISO 27186 2010 E I I I Indications and Usage ndications and Usage ndications and Usage ndications and Usage St Jude Medical ICDs and CRT Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation fo...

Страница 8: ...transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Warnings and Precautions Warnings and Precautions Warnings and Precautions Warnings and Precautions Resuscitation Availability Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation CPR are readily available Lead system D...

Страница 9: ...al Inc could void the user s authority to operate this device Suboptimal radio frequency RF communication The Merlin PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the Merlin PCS and the Merlin Antenna Below is a list of potential causes to suboptimal radio communication Table 4 Possible causes and solutions for suboptimal RF communication Possib...

Страница 10: ... and the device is free from interfering objects people The Merlin Antenna is too far away from the device Move the Merlin Antenna closer to the device Someone is holding the Merlin Antenna Place the Merlin Antenna on a flat surface Do not hold the Merlin Antenna Other products in the vicinity are causing electromagnetic interference EMI Power off or remove equipment that could cause EMI The Merli...

Страница 11: ...dical Device storage Store the device in a clean area away from magnets kits containing magnets and sources of electromagnetic interference to avoid device damage Store the device between 10 and 45 C because temperatures outside this range may damage the device Temperature Equilibration After cold storage allow the device to reach room temperature before charging the capacitors programming or impl...

Страница 12: ...o deeper than 5 cm to ensure reliable data transmission For patient comfort do not implant the pulse generator within 1 25 cm of bone unless you cannot avoid it Exercise caution when turning the setscrew which may be backed out of the connector if turned counterclockwise for more than two rotations Program the device parameters as specified in the Merlin PCS on screen help The results of the DAVID...

Страница 13: ...py Hazards Environmental and Medical Therapy Hazards Environmental and Medical Therapy Hazards Environmental and Medical Therapy Hazards Instruct patients to avoid devices which generate a strong electric or magnetic interference EMI EMI could cause device malfunction or damage resulting in non detection or delivery of unneeded therapy Moving away from the source or turning it off will usually all...

Страница 14: ...alt 60 or gamma radiation at the pulse generator If a patient requires radiation therapy in the vicinity of the pulse generator place lead shielding over the device to prevent radiation damage and confirm its function after treatment Lithotripsy Lithotripsy may permanently damage the pulse generator Avoid it unless the therapy site is not near the pulse generator and leads Diathermy Avoid diatherm...

Страница 15: ...rvices and must accept any interference received including interference that may cause undesired operation WARNING WARNING WARNING WARNING This transmitter is authorized by rule under the Medical Implant Communications This transmitter is authorized by rule under the Medical Implant Communications This transmitter is authorized by rule under the Medical Implant Communications This transmitter is a...

Страница 16: ...lant Communications Service Analog and digital voice nalog and digital voice nalog and digital voice nalog and digital voice communications are prohibited Although this transmitter has been approved by the communications are prohibited Although this transmitter has been approved by the communications are prohibited Although this transmitter has been approved by the communications are prohibited Al...

Страница 17: ... disturbances caused by electric hand tools or electric razors used directly over the pulse generator implant site Industrial equipment A variety of industrial equipment produce EMI of sufficient field strength and modulation characteristics to interfere with proper operation of the pulse generator These include but are not limited to arc welders induction furnaces very large or defective electric...

Страница 18: ...t may set off the airport security system alarm If the alarm does sound the patient should present security personnel with their patient identification card If security personnel perform a search with a handheld wand the patient should ask that they perform the search quickly stressing that they should avoid holding the wand over the device for a prolonged period Cellular Phones Cellular Phones Ce...

Страница 19: ...de but are not limited to the following Acceleration of arrhythmias caused by device Air embolism Allergic reaction Bleeding Cardiac tamponade Chronic nerve damage Death Erosion Exacerbation of heart failure Excessive fibrotic tissue growth Extracardiac stimulation phrenic nerve diaphragm chest wall Extrusion Fluid accumulation Formation of hematomas or cysts Inappropriate shocks ...

Страница 20: ...ty due to inability to defibrillate or pace Thromboemboli Venous occlusion Venous or cardiac perforation Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT D system that may include the following Dependency Depression Fear of premature battery depletion Fear of shocking while conscious Fear of losing shock capabi...

Страница 21: ...e default Atrial Sensitivity enuation Filter the default Atrial Sensitivity setting the lowest possible setting of Ventricular Sensitivity 0 2 mV and the Ventricular setting the lowest possible setting of Ventricular Sensitivity 0 2 mV and the Ventricular setting the lowest possible setting of Ventricular Sensitivity 0 2 mV and the Ventricular setting the lowest possible setting of Ventricular Sen...

Страница 22: ...NGLE USE ONLY Do not resterilize and re implant explanted pulse generators St Jude Medical has sterilized the pulse generator with ethylene oxide prior to shipment Contact St Jude Medical if resterilization is necessary Do not implant the device when It has been dropped on a hard surface because this could have damaged pulse generator components The sterility indicator within the inner package is ...

Страница 23: ...ns Sterilization Instructions Contact St Jude Medical if resterilization is necessary Directions for Use Directions for Use Directions for Use Directions for Use Pulse generator operating characteristics should be verified at the time of implantation and recorded in the patient file Complete the Patient Registration Form and return it to St Jude Medical as it provides necessary information for war...

Страница 24: ...CD1311 36 36Q CD2275 36 36Q CD2311 36 36Q KF CD1257 40 40Q CD2257 40 40Q CD3257 40 40Q CD3265 40 40Q KC Package Conten Package Conten Package Conten Package Contents ts ts ts The pulse generator is supplied in a sterile tray for introduction into the operating field The tray contains One pulse generator with all tachyarrhythmia therapies off with pre installed setscrews Torque driver The outer box...

Страница 25: ...or technical questions and support 1 818 362 6822 1 800 722 3774 toll free within North America 46 8 474 4147 Sweden For additional assistance call your local St Jude Medical representative Additional Information Additional Information Additional Information Additional Information For additional information on this device see the programmer s on screen help ...

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Страница 28: ...Cardiac Rhythm Management Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 Veddestavägen 19 SE 175 84 Järfälla Sweden 46 8 474 4000 sjm com April 2012 Art 60031731 A ...

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