Страница 1: ...Ellipse Fortify Assura Tiered therapy Cardioverter Defibrillator Quadra Assura Quadra Assura MP Unify Assura Cardiac Resynchronization Device Tiered therapy Cardioverter Defibrillator ...
Страница 2: ...cer and birth defects or other reproductive harm For more information go to www P65Warnings ca gov Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical LLC and its related companies Pat http patents sjm com 2017 St Jude Medical LLC Al...
Страница 3: ... Type Delivered Energy approx MRI Status Fortify Assura VR CD1257 40 Single chamber ICD with RF telemetry DF 1 IS 1 40 J Untested Fortify Assura VR CD1257 40Q Single chamber ICD with RF telemetry DF4 LLHH 40 J Untested Ellipse VR CD1275 36 Single chamber ICD with RF telemetry DF 1 IS 1 36 J Untested Ellipse VR CD1275 36Q Single chamber ICD with RF telemetry DF4 LLHH 36 J Untested ...
Страница 4: ...amber ICD with RF telemetry DF4 LLHH 36 J MR Conditional Fortify Assura VR CD1357 40 Single chamber ICD with RF telemetry DF 1 IS 1 40 J Untested Fortify Assura VR CD1357 40C Single chamber ICD with RF telemetry Parylene coating DF 1 IS 1 40 J Untested Fortify Assura VR CD1357 40Q Single chamber ICD with RF telemetry DF4 LLHH 40 J Untested Fortify Assura VR CD1357 40QC Single chamber ICD with RF t...
Страница 5: ... Single chamber ICD with RF telemetry DF 1 IS 1 36 J Untested Ellipse VR CD1411 36C Single chamber ICD with RF telemetry Parylene coating DF 1 IS 1 36 J Untested Ellipse VR CD1411 36Q Single chamber ICD with RF telemetry DF4 LLHH 36 J MR Conditional Ellipse VR CD1411 36QC Single chamber ICD with RF telemetry Parylene coating DF4 LLHH 36 J MR Conditional ...
Страница 6: ...ith RF telemetry DF4 LLHH IS 1 40 J Untested Ellipse DR CD2275 36 Dual chamber ICD with RF telemetry DF 1 IS 1 36 J Untested Ellipse DR CD2275 36Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 36 J Untested Ellipse DR CD2311 36 Dual chamber ICD with RF telemetry DF 1 IS 1 36 J Untested Ellipse DR CD2311 36Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 36 J MR Conditional Fortify Assura DR C...
Страница 7: ...ating DF 1 IS 1 40 J Untested Fortify Assura DR CD2357 40Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 40 J Untested Fortify Assura DR CD2357 40QC Dual chamber ICD with RF telemetry Parylene coating DF4 LLHH IS 1 40 J Untested Ellipse DR CD2411 36 Dual chamber ICD with RF telemetry DF 1 IS 1 36 J Untested Ellipse DR CD2411 36C Dual chamber ICD with RF telemetry Parylene coating DF 1 IS 1 36 J...
Страница 8: ...tatus Ellipse DR CD2411 36Q Dual chamber ICD with RF telemetry DF4 LLHH IS 1 36 J MR Conditional Ellipse DR CD2411 36QC Dual chamber ICD with RF telemetry Parylene coating DF4 LLHH IS 1 36 J MR Conditional Table 3 CRT D pulse generator descriptions Name Model Number Description Connector Type Delivered Energy approx MR Status ...
Страница 9: ...try DF4 LLHH IS 1 40 J Untested Quadra Assura CD3265 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40 J Untested Quadra Assura CD3265 40Q CRT D with RF telemetry DF4 LLHH IS4 LLLL IS 1 40 J Untested Quadra Assura MP CD3269 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40J Untested Quadra Assura MP CD3269 40Q CRT D with RF telemetry DF4 LLHH IS4 LLLL IS 1 40J Untested Unify Assura CD3357 40 CRT D w...
Страница 10: ... coating DF 1 IS 1 40 J Untested Unify Assura CD3357 40Q CRT D with RF telemetry DF4 LLHH IS 1 40 J Untested Unify Assura CD3357 40QC CRT D with RF telemetry Parylene coating DF4 LLHH IS 1 40 J Untested Quadra Assura CD3365 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40 J Untested Quadra Assura CD3365 40C CRT D with RF telemetry Parylene coating DF 1 IS 1 IS4 LLLL 40 J Untested ...
Страница 11: ...S 1 40 J Untested Quadra Assura CD3365 40QC CRT D with RF telemetry Parylene coating DF4 LLHH IS4 LLLL IS 1 40 J Untested Quadra Assura MP CD3369 40 CRT D with RF telemetry DF 1 IS 1 IS4 LLLL 40J Untested Quadra Assura MP CD3369 40C CRT D with RF telemetry Parylene coating DF 1 IS 1 IS4 LLLL 40 J Untested Quadra Assura MP CD3369 40Q CRT D with RF telemetry DF4 LLHH IS4 LLLL IS1 40J Untested ...
Страница 12: ...r transvenous or transthoracic techniques The St Jude Medical Merlin Patient Care System PCS with software model 3330 version 24 0 1 or greater a Merlin Antenna for devices with RF communication and a telemetry wand constitute the external portion of the ICD and CRT D systems Models with the Q suffix are functionally equivalent in all respects to the same model without the Q suffix except for the ...
Страница 13: ...nction In patients indicated for an ICD CRT Ds are also intended to provide a reduction of the symptoms of moderate to severe heart failure NYHA Functional Class III or IV in those patients who remain symptomatic despite stable optimal medical therapy as defined in the clinical trials section included in the Merlin PCS on screen help and have a left ventricular ejection fraction less than or equal...
Страница 14: ...citation CPR are readily available Lead system Do not use another manufacturer s lead system without demonstrated compatibility as undersensing cardiac activity and failure to deliver necessary therapy may result Avoiding shock during handling Disable tachyarrhythmia therapy Enable Disable Tachy Therapy or program tachyarrhythmia therapies Off during surgical implant and explant or post mortem pro...
Страница 15: ... 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 Possible Causes Solutions The Merlin Antenna orientation location is suboptimal Move or reorient the Merlin Antenna slightly Make sure that the front of the Merlin Antenna faces the implantable device People or objects interfere with th...
Страница 16: ...enna Make sure the Merlin Antenna cable is not wound around the Merlin Antenna Magnetic Resonance Imaging MRI MR Conditional devices Testing has demonstrated that the St Jude Medical MR Conditional system is conditionally safe for use in the MRI environment when used according to the instructions in the MRI Procedure Information document The St Jude Medical MR Conditional system includes a St Jude...
Страница 17: ...the sterile packaging may be compromised Return the device to St Jude Medical Device storage Store the device in a clean area away from magnets kits containing magnets and sources of electromagnetic interference page 20 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 dev...
Страница 18: ...no 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 DAVI...
Страница 19: ...use of the potential for explosion Explant the device before cremation 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 allow the pulse generator t...
Страница 20: ...ion High radiation sources Do not direct high radiation sources such as cobalt 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 ther...
Страница 21: ... ablation catheter and the implanted lead or pulse generator Positioning the groundplate so that the current pathway does not pass near the pulse generator system i e place the groundplate under the patient s buttocks or legs Having external defibrillation equipment available RF Operating Frequencies Nearby equipment emitting strong magnetic fields can interfere with RF communication even if the o...
Страница 22: ...s governing the Medical Device Radiocommunication Service Analog and digital voice communications are prohibited Although this transmitter has been approved by the Federal Communications Commission there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference The following is applicable to Canada only This devic...
Страница 23: ...nt 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 motors and internal combustion engines with poorly shielded ignition systems Electronic Article Surveillance Security and Logistical Systems and Metal Detectors Advise patients that the Electr...
Страница 24: ...e generator has been tested for compatibility with handheld wireless transmitters in accordance with the requirements of ISO 14117 This testing covered the operating frequencies 450 MHz 3 GHz and pulsed modulation techniques of all of the digital cellular phone technologies in worldwide use today Based on the results of this testing the pulse generator should not be affected by the normal operatio...
Страница 25: ... failure Excessive fibrotic tissue growth Extracardiac stimulation phrenic nerve diaphragm chest wall Extrusion Fluid accumulation Formation of hematomas or cysts Inappropriate shocks Infection Keloid formation Lead abrasion and discontinuity Lead migration dislodgment Myocardial damage ...
Страница 26: ...usion 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 capability Imagined shocking phantom shock Clinician Use Information WARNIN...
Страница 27: ... of Ventricular Sensitivity 0 2 mV and the Ventricular Sensitivity setting of 0 3 mV when the Low Frequency Attenuation Filter is On may be more susceptible to EMI according to testing required by CENELEC standard EN45502 2 2 The devices comply with the electromagnetic compatibility requirements of CENELEC standard EN45502 2 2 at atrial sensitivities of 0 3 mV ventricular sensitivities of 0 3 mV L...
Страница 28: ... package is purple because it might not have been sterilized Its storage package has been pierced or altered because this could have rendered it non sterile It has been stored or transported outside the environmental temperature limits Storage limits 10 to 45 C Transportation limits 20 to 60 C An electrical reset condition may occur at temperatures below 20 C After cold storage allow the device to...
Страница 29: ...lantation and recorded in the patient file Complete the Patient Registration Form and return it to St Jude Medical as it provides necessary information for warranty purposes and patient tracking Copies of this user s manual can be obtained by contacting your St Jude Medical representative Radiopaque Identification Each pulse generator has an X ray absorptive marker for non invasive identification ...
Страница 30: ...2357 40 40C 40Q 40QC CD3257 40 40Q CD3265 40 40Q CD3357 40 40C 40Q 40QC CD3365 40 40C 40Q 40QC CD3269 40 40Q 3369 40 40C 40Q 40QC KC Package Contents 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 contains Literature ...
Страница 31: ...ort 1 818 362 6822 1 800 722 3774 toll free within North America 46 8 474 4147 Sweden 61 2 9936 1200 Australia manuals sjm com For additional assistance call your local St Jude Medical representative Additional Information For additional information on this device see the programmer s on screen help ...
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Страница 34: ...anagement Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 sjm com 2017 09 ARTEN100158113 A ...
