Cordella™ Pulmonary Artery Sensor System Instructions for Use Exclusively for Clinical Investigations. To be used by Qualified Investigators Only. Endotronix Ireland Limited 815 Ogden Avenue Lisle, IL 60532 info@endotronix.
(page left blank intentionally) Table of Contents 1. Introduction 5 1.1 Intended Use 1.2 Contraindications 5 5 2. Device Descriptions 8 2.1 Cordella™ PA Sensor 2.2 myCordella Patient Reader 2.3 Delivery System 2.4 Calibration Equipment 2.5 Cordella Data Analysis Platform (CDAP) 2.6 Recommended Accessories 8 8 9 9 9 10 3. Safety Information 11 3.1 Warnings: Implantation Procedure 3.2 Warnings: Reader and Docking Station 3.3 Precautions 3.4 Potential Adverse Events 3.
10. Maintenance and Storage 38 10.1 Environmental Information 10.2 Replacement and Repair 38 38 12. Return Materials Authorization (RMA) 40 13. Inspection & Cleaning Instructions 40 14. Troubleshooting 41 14.1 Implant Procedure & Delivery System 14.2 Pairing and Interrogating the Cordella Sensor 14.3 Calibrating the Cordella Sensor 41 42 42 15.
1.3 Component Names 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 myCordella Hub to the clinician. The PMP is intended to assist clinicians in efficiently and effectively managing patients and driving treatment changes when necessary.
2. Device Descriptions 2.3 Delivery System The Cordella Pulmonary Artery Sensor System measures pulmonary artery (PA) pressure on demand to help clinicians identify pulmonary congestion suggestive of worsening heart failure through evaluation of trends of pulmonary artery pressure values.
2.6 Recommended Accessories Cordella Pulmonary Artery Sensor System is recommended for use with the accessories listed in the following table. These accessories are not included in the Cordella Sensor and Delivery System packaging. Item Specifications Vascular Access Kit 14 Fr Introducer Sheath (see recommendation) and dilators with preferred access guidewire (no Endotronix recommendation) 14F Introducer Sheath Cook performer introducer, Item No. G08024 RCF 14.
• During the implant procedure, there should be a continuous heparin drip to prevent clotting. Warnings: Implantation Procedure (Cont.) • Use only the cables and accessories provided. The use of accessories, transducers, or cables other than those specified, with the exception of transducers and cables provided as replacement parts, may result in increased emissions, decreased immunity of the system, inaccurate readings, damage to the system, injury to user, or improper operation.
Warnings: Reader and Docking Station (Cont.) 3.3 Precautions • myCordella Patient Reader may be interfered with by other equipment generating electromagnetic fields. When possible, avoid using the Reader while simultaneously using other equipment within ~1.5 meters such as: patient monitoring systems, chest EKG leads, motors on motorized beds, pagers, laptop computers, tablets, cell phones, cordless phones, wireless routers, air conditioners, or walkie talkies (450MHz devices) within ~3 meters.
Precautions (Cont.) • DO NOT place more than one Cordella Sensor in a patient. The two Cordella Sensors may interfere with each other and limit the ability to obtain accurate readings. • The mean pressure measurement accuracy of the system may be affected by various factors.
3.5 MRI Safety Information Non-clinical testing and MRI simulations were performed to evaluate the Cordella Sensor. Non-clinical testing demonstrated that the Cordella Sensor is MR Conditional. A patient with this implant can be scanned safely in an MR system under the following conditions: NOTE: It is important that the patient understands they should inform clinical staff who will be performing an MRI scan that the patient has an implanted Cordella Sensor and to refer to these guidelines.
4. Instructions for Use 4.2 Pairing and Interrogating the Cordella Sensor in Packaging Implanting physicians are required to have completed the Cordella Pulmonary Artery Sensor System training, which includes didactic and clinical education material. 1. Press ‘Calibrate.’ Scan the barcode on the Delivery System unit box. 4.1 Pre-Procedure Preparation 1. 2.
7. On the confirmation screen, ensure all Cordella Sensor and patient information is correct. 4.4 Vessel Mapping and Guidewire Placement The 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 DO NOT scan visibly damaged barcodes; use a different Delivery System package. Downturn 4.3 Delivery System Package Inspection Main Bifurcation 1.
4. Exchange the catheter for a pigtail catheter and remove the guidewire. Ensure the pigtail catheter extends into the right PA as shown. 5. Inject contrast agent through the pigtail catheter to illuminate the right pulmonary artery and provide a roadmap for identifying proper Sensor deployment location. Using the markers on the pigtail (10mm spacing) estimate the diameter of the right PA main vessel at the downturn. The vessel at this location must be between 12-30mm.
4.5 Delivery System & Cordella Sensor Insertion 1. 2. 4. Catheterization lab staff should assist the implanter in sterile removal of the Cordella Sensor and Delivery System from the sterile packaging and record the Sensor Serial Number in the patient’s chart with the peel and stick label. Inspect the entire effective length of the Delivery System carefully for any damage, including kinks, burrs, roughness, or tight connections.
3. Once in the optimal position, the Cordella Sensor has three (3) radiopaque marker bands to help identify rotational position of the Sensor. Rotate the Cordella Sensor using the Torque Handle as necessary to ensure the Sensor is anterior facing as shown below: 4. Once in target deployment position (Sensor body at RPA downturn, anterior facing), deploy the Cordella Sensor by detaching and pulling the release wire cap, then fully removing the release wires. Release wire cap and wires may be discarded.
6. While visualizing under fluoroscopy, gently and slowly withdraw the Torque Catheter past the Cordella Sensor, making sure not to disturb the Cordella Sensor location. Leave the Stability Sheath in place near the newly deployed Cordella Sensor. Once the Torque Catheter is fully removed, separate the guidewire and discard the Torque Catheter.
4. Imediately after, CalEQ will calibrate the Cordella Sensor for 18 seconds. Do not adjust the Reader position during this time. A progress bar above the waveform 5. Transport displays the progress through calibration, and the live waveform will be paused. To transport the CalEQ, turn off the computer. To do this, press the “Menu” button (three horizontal lines), select “End Session”, then select “Power Off”. Unplug the power strip and wrap up the power cord.
8. Patient Reader Training Post-implant, patients should complete training on CalEQ to learn the best placement of the Reader. 1. From the CalEQ home screen, the user can press the “Training” button. 2. CalEQ will display an animation that walks through the steps of taking a reading. 3. After the training video, the trainer or patient can press the “Start Training” button, undock the Reader when prompted, and automatically move into the Training screens. 4.
9. Reader/Docking Station Audio & Visual Cues Reader Audio Cues Event Sound Required Action Searching for Implant Two descending beeps, repeating every ~2 seconds Reposition Reader to find stronger signal. Reader Visual Cues Light Event/Required Action Solid Blue Searching for Sensor. Slowly Flashing Blue Return to Docking Station. Rapidly Flashing Blue Sensor located. Ready to begin reading. Slowly Flashing Green Reading in progress. Hold Reader in place until light becomes solid green.
10. Maintenance and Storage 10.1 Environmental Information Store the Delivery System and Cordella Sensor in standard hospital storage conditions. Keep dry and out of sunlight. The CalEQ computer, Docking Station, and backup Docking Station should remain plugged into the power strip. The Reader and backup Reader should remain in the Docking Stations when not in use. Reference the Equipment Specifications in Appendix B for specific storage conditions.
13. Inspection & Cleaning Instructions Inspect the CalEQ system regularly. If any of the inspection checkpoints apply, please contact Customer Support. Inspection Checklist • Power cords are not frayed or connected to unauthorized equipment. If there is a frayed power cord or if the unit is attached to unauthorized equipment, unplug the unit and notify Customer Support to obtain a new one. 14. Troubleshooting 14.
barcode scanner is connected properly to the handle and the CalEQ. If the barcode scanner not functioning properly, contact Endotronix Customer Support. 2. Check that the QR barcode is not smeared, rough, scratched, exhibiting voids, or coated with frost or water droplets. If the QR barcode on the Delivery System packaging is damaged, contact Endotronix Customer Support for assistance. If the QR barcode from the QR Barcode Report is damaged, re-print the QR Barcode Report from PMP.
Appendices Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Appendix A: Electromagnetic Compatibility The Reader and Docking Station are intended for use in the electromagnetic environment specified below. The myCordella™ Patient Reader and Docking Station are investigational devices that comply with IEC 60601-1-2 Ed. 4.0. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions & Immunity Immunity These are investigational devices that comply with IEC 60601-1-2 Ed. 4.0.
Radiated RF Immunity IEC 61000-4-3 10V/m 80MHz-2.7GHz 80% AM at 1kHz 10V/m Conducted RF Immunity IEC 61000-4-6 3 Vrms Outside the ISM Bands 3 Vrms Outside the ISM Bands 6 Vrms In the ISM and amateur radio bands 6 Vrms In the ISM and amateur radio bands 150kHz to 80MHz Portable and mobile RF communication equipment should be no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
radio frequency energy and, if not used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
EMC standards: Meets all relevant parts of IEC 60601-1-2 Ed. 4.0 EMC: Meets all relevant parts of IEC 60601-1-2 Operating frequency: 12.88-14.12 MHz, 2.45 GHz myCordella™ Docking Station Physical Manufacturer: Endotronix Approximate dimensions Exclusively for Clinical Investigations • • • • Expected service life: One year Width: 6.44 in / 16.35 cm Height: 2.0 in / 5.1 cm Depth: 5.63 in / 14.3 cm Weight: 1.1 lbs. / 0.5 kg Physical Approximate dimensions • • • • Power Input of 4.2V/16.
Environment The CalEQ may not meet its performance specifications if stored or used outside the temperature and humidity ranges listed below. Temperature • Operation: 5 – 35 °C (41 – 95 °F) • Storage: -20 – 60 °C (-4 – 140 °F) 'HÿQLWLRQ RI 6\PEROV The following symbols are used on the labels of the Cordella Pulmonary Artery Sensor System. Manufacturer’s catalogue or part number so that the medical device can be identified.
Device that needs to be protected from moisture. IP21 Protected against solid foreign objects of 12.5 mm and greater, and against the effects of dripping water. Federal Communication Commission Number IP22 Protected against solid foreign objects of 12.5 mm and greater, and against the effects of dripping water when tilted at 15°. Device that can be broken or damaged if not handled carefully. IP42 Protected against solid foreign objects of 1.
Cordella, myCordella, and Endotronix are trademarks of Endotronix, Inc. ©2018 Endotronix, Inc.
