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Cordella

™

Pulmonary Artery Sensor System

Instructions for Use

815 Ogden Avenue
Lisle, IL 60532
[email protected]
Phone: 1-888-512-5595

Endotronix Ireland Limited

DCU Alpha Innovation Center

Old Finglas Road

Glasnevin

Dublin 11, D11 KXN4

Ireland

Exclusively for Clinical Investigations.

To be used by Qualified Investigators Only.

Содержание Cordella

Страница 1: ...5 Ogden Avenue Lisle IL 60532 info endotronix com Phone 1 888 512 5595 Endotronix Ireland Limited DCU Alpha Innovation Center Old Finglas Road Glasnevin Dublin 11 D11 KXN4 Ireland Exclusively for Clin...

Страница 2: ...cking Station 13 3 3 Precautions 15 3 4 Potential Adverse Events 17 3 5 MRI Safety Information 18 3 6 Sterilization 19 4 Instructions for Use 20 4 1 Pre Procedure Preparation 20 4 2 Pairing and Interr...

Страница 3: ...ent facing myCordella System Pack and the clinic facing myCordella Patient Management Portal PMP The Cordella PA Sensor is an implantable blood pressure monitor that permanently resides in the patient...

Страница 4: ...not pictured Cordella Heart Failure System This system is commericially available myCordella Patient Management Portal PMP A web based application that displays patient data received from the myCordel...

Страница 5: ...view 2 3 Delivery System The Delivery System is a catheter with a pre loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the pulmonary artery The Delivery System...

Страница 6: ...for visualization DO NOT use an automated injector through the Stability Sheath Patient Monitor 3 Safety Information Before use of the Cordella Pulmonary Artery Sensor System thoroughly read and under...

Страница 7: ...y and return the device to Endotronix through the RMA process After Cordella Sensor deployment take care to remove the Delivery System slowly and gently to avoid moving the Cordella Sensor DO NOT atte...

Страница 8: ...ewire Do not aspirate or infuse the Delivery System guidewire lumen during use The implant procedure is an adjunct to a standard RHC procedure All standard protocols for the RHC should be followed The...

Страница 9: ...components are exposed to liquids DO NOT drop the Reader Handle with care If dropped the Reader may expose the battery If the battery is exposed contact Endotronix immediately for a replacement Reade...

Страница 10: ...rameters may be necessary if the goal is to image close to the Cordella Sensor In non clinical testing the image artefact caused by the Cordella Sensor extends approximately 6 mm from this device when...

Страница 11: ...ader on press and hold the small button at the base of the Reader for several seconds 4 Turn on the CalEQ by pressing the power button on the bottom of the monitor and sign in as the CalEQ user 4 2 Pa...

Страница 12: ...Cordella Sensor is implanted in the patient s right pulmonary artery The following image is provided for reference with useful anatomical landmarks indicated Apical Branch Downturn Right PA Main Bifu...

Страница 13: ...downturn The vessel at this location must be between 12 30mm If the vessel appears to be either larger or smaller than the indicated range abort the procedure and DO NOT implant the Cordella Sensor 1...

Страница 14: ...ged or defective do not use the product and contact Customer Support WARNING The Cordella Sensor should not be interrogated by the Reader after removal from the packaging until the Sensor is implanted...

Страница 15: ...nce the Cordella Sensor to the target area using the Torque Handle to navigate through the heart to the right pulmonary artery 3 Once in the optimal position the Cordella Sensor has three 3 radiopaque...

Страница 16: ...ap onto the Stability Sheath hub to prevent back bleeding through the hemostasis valve WARNING Avoid torquing the Stability Sheath when used as a fluid filled column Torquing can result in kinks which...

Страница 17: ...Station should remained plugged into the power strip The Reader and backup Reader should remain in the Docking Stations during transport Lower the CalEQ screen as far as possible by depressing the foo...

Страница 18: ...hen prompted and automatically move into the Training screens 4 As the patient moves the Reader around on their chest and side they will receive feedback on the signal strength from CalEQ As signal st...

Страница 19: ...beeps repeating every 10 seconds When accompanied by flashing red light call Customer Support Reader Visual Cues Light Event Required Action Solid Blue Searching for Sensor Slowly Flashing Blue Retur...

Страница 20: ...r damage to any system component including power accessories request a replacement from Endotronix and follow the RMA process described below as requested by Customer Support Software con guration of...

Страница 21: ...decision is made not to deploy the Cordella Sensor after it has been inserted through the introducer sheath slowly retract the Delivery System until the Cordella Sensor is in contact with the distal...

Страница 22: ...he Home Screen and start the calibration work ow from the beginning If the Reader is picked up from the Docking Station and CalEQ says Reader Not Found repeat the procedure with the backup Reader and...

Страница 23: ...peci ed below Immunity Test Test Level Compliance Electromagnetic Environment Guidance Electrostatic Discharge Immunity IEC 61000 4 2 8kV contact 2kV 4V 8kV 15kV air 8kV contact 2kV 4V 8kV 15kV air Fl...

Страница 24: ...ienting or relocating the myCordella b See examples of calculated separation distances in next table Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and myCord...

Страница 25: ...301 489 17 ETSI EN 300 330 CISPR 11 Development and testing for the Cordella Pulmonary Artery Sensor System has been conducted with the guidance of the following standards and regulations ISO 10993 1...

Страница 26: ...1 2 myCordella Docking Station Manufacturer Endotronix Exclusively for Clinical Investigations Expected service life One year Physical Approximate dimensions Width 5 5 in 14 0 cm Height 2 5 in 6 4 cm...

Страница 27: ...EU o Cord Length approx 3 meters Computer Monitor o System Input 12 48V o AC Adapter Input 100 240V 50 60 Hz 1 3 0 6A Output 19V 4 74A 90W MAX Cord Length approx 2 meters H QLWLRQ RI 6 PEROV The foll...

Страница 28: ...ined degree of particle and water ingress protection where N1 degree of protection from particulates scale of 0 6 and N2 degree of protection from water scale of 0 8 IP21 Protected against solid forei...

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