Patient Reader Manual IMPORTANT PLEASE READ THIS MANUAL BEFORE USING THE CORDELLA™ PULMONARY ARTERY SENSOR SYSTEM CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use. Endotronix Ireland Limited 815 Ogden Ave Lisle, IL 60532 www.endotronix.com 1-888-512-5595 © 2019 Endotronix® Inc. DCU Alpha Innovation Centre Old Finglas Road, Glasnevin Dublin 11, D11 KXN4 Ireland 100469-00 Rev.
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Table of Contents Introduction ...................................................................................... 4 The Cordella™ Pulmonary Artery Sensor System ............................... 5 Safety Information ............................................................................ 6 Patient Privacy and Medical Privacy Standards ................................. 7 Implant procedure ............................................................................ 7 Before the Implant Procedure .......
Introduction The Cordella™ Pulmonary Artery (PA) Sensor System is intended to connect healthcare professionals and patients with tools designed to improve comprehensive heart failure management. This guide provides basic information about instructions for use of the Cordella™ Pulmonary Artery Sensor System in the home. NOTE: The information provided in this patient manual does not attempt to define any intervention, health care policy, or procedures.
The Cordella™ Pulmonary Artery Sensor System Cordella Pulmonary Artery Sensor System is an innovative myCordella™ peripheral designed for on-demand measurement of PA pressure from your home. This may help your healthcare providers identify pulmonary congestion suggestive of worsening heart failure through trends in PA pressures. Component Name Cordella™ Pulmonary Artery Sensor (Cordella Sensor) Small implant that resides permanently in the pulmonary artery.
Safety Information To prevent personal injury or damage to any equipment, please read and observe all safety information. Warnings Precautions This symbol indicates “the possibility of system damage or malfunction, delay in receipt of information to a doctor, inaccurate readings, or injury.” This symbol indicates “the possibility of system damage, malfunction, or the delay in treatment.
• If the skin becomes red, warm, or irritated, immediately stop using the Reader and contact customer service. • Contact Endotronix customer service if more than 1 Cordella user resides in the same home. DO NOT use more than one Reader in the same general vicinity at one time, as use of multiple Readers at once may cause them to interfere with each other. • The Reader contains Lithium Ion batteries. DO NOT place the Reader on a hot surface.
System. You will be given a detailed description of the procedure, your doctor will discuss the risks associated with the procedure and the Sensor, your doctor will respond to any questions you have, and you will be asked to sign an informed consent. Inform your doctor of any infections, arrhythmias, or bleeding that occurs before the implant procedure.
6. 7. 8. 9. doctor a better idea of what the vessels in your pulmonary arteries look like and will help guide placement of the sensor to the best possible position. This is called angiography. At this point the pulmonary catheter is removed, the catheter with attached Cordella Sensor replaces it, and the best possible position for the Sensor is confirmed. Once the Sensor is in the best possible position, your doctor will implant it.
Getting Started The myCordella™ Patient Reader will automatically pair with the myCordella Hub on start-up. No additional user input is required. Upon return home with the myCordella Reader and Docking Station, connect the Docking Station Power Cord to the power port on the back of the Docking Station and the other end into the wall outlet. Place the Docking Station on a flat surface near the myCordella Hub with a minimum two-inch/five-centimeter clearance from surrounding objects or walls.
Taking a Reading The handheld Reader should be removed from the Docking Station using the left hand for ease of locating the Cordella™ Sensor in the right PA (right side of the chest). It is essential for proper operation of the Reader to maintain a metal free zone in the area where the reading will take place and to take each reading in a consistent body position. Remove all necklaces, watches and jewelry prior to beginning the measurement within 3 inches/8 cm of your prescribed reading location.
4. During the reading, it is important to remain still and hold the Reader as still as possible. The light on the Reader will blink GREEN during a reading. Continue to breathe normally during the reading. 5. After ~18 seconds the Reader will play a “Success” tone if the reading worked properly. The light on the Reader will become a solid GREEN. a. In the event the reading obtained was not good enough due to movement or improper Reader placement, the Reader will play a “Fail” tone.
Audio & Visual Cues Reader Audio Cues Event Searching for Sensor Sensor Located Reading in Progress Successful Sensor Reading Failed Reading Return to Docking Station Low Battery Contact Customer Service Sound Two descending beeps, repeating every ~2 seconds Four quickly ascending, high pitched beeps, repeating three times Two quickly ascending beeps, repeating every ~3 seconds Several quickly ascending, high pitched beeps Several slowly descending, low pitched beeps Successful Reading sound repeating p
Light Off Out of battery. Return to Docking Station. Docking Station Visual Cues Light Flashing White Solid White No Light Event/Required Action The Reader is being charged. The Reader is fully charged and ready for use. When the Reader is docked and no light is present, the Docking Station is not connected to a power source. Check that the Docking Station Power Cord is plugged into both Docking Station and electrical outlet. If the light remains off, contact customer service.
If the button is depressed but the Reader doesn’t respond, the battery is likely discharged; return the Reader to the Docking Station and allow the Reader to charge fully. Ensure you carry your implant ID card with you at all times. The Reader contains lithium ion batteries. DO NOT transport in checked luggage. Wait 5 minutes to take a reading after disabling Travel Mode to allow the Reader to warm-up.
Return Materials Authorization (RMA) If customer service requests that the equipment be returned, please follow the directions below. 1) Check off each item on the equipment return list and carefully pack the equipment in the original shipping box or equivalent with its original protective packaging materials. 2) Include the RMA number given to you by customer service on the outside of the shipping container.
Cleaning o Clean the systems components as needed. o UNPLUG the Docking Station and remove the Reader before cleaning or disinfecting. o Put the Reader in “Travel Mode” to minimize audio signals while cleaning. o To clean, wipe the surfaces with a lint-free cloth lightly moistened in water. o DO NOT disassemble. Clean only the surfaces of the Reader and Docking Station. o DO NOT immerse the Reader or Docking Station in any liquid.
APPENDICES Appendix A: Cordella™ Pulmonary Artery Sensor System Components Use only supplies authorized by Endotronix®, as other equipment may result in increased electromagnetic emissions, decreased immunity to emissions, or damage to the system. To order supplies, contact customer service and include the part number and name. Endotronix, Inc. 815 Ogden Ave Lisle, IL 60532 USA Info@endotronix.
Appendix B: Equipment Specifications myCordella™ Patient Reader Manufacturer: Endotronix® CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use. Method of measurement: Wireless interrogation of implanted Cordella Sensor Pulmonary artery pulse pressure maximum range: 40-100 mmHg Pulmonary artery pressure range at sea level: 0-100 mmHg Pressure Transducer Accuracy: +/- 7.
Temperature • Operation: 15 – 30°C (59 – 86°F) • Storage: -10 – 55°C (14 – 131°F) Relative humidity • Operation: 6 – 93% (non-condensing) • Storage: 15 – 93% (non-condensing) EMC: Meets all relevant parts of IEC 60601-1-2 myCordella™ Docking Station Manufacturer: Endotronix® CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use. Expected service life: One year Physical Approximate dimensions • Width: 5.5 in / 14.0 cm • Height: 2.5 in / 6.4 cm • Depth: 5.
Appendix C: Electromagnetic Guidance Guidance and Manufacturer’s Declaration – Electromagnetic Emissions & Immunity The myCordella™ Patient Reader and Docking Station are investigational devices that comply with IEC 60601-1-2 Ed. 4.0. The Reader and Docking Station are Class II ME Equipment and the Reader is a BF Applied Part. The Reader and Docking Station are intended for use in the electromagnetic environment specified below.
Electrical Fast Transient/Burst Immunity IEC 61000-4-4 Surge IEC 61000-4-5 ±2 kV for power supply lines ±2 kV for power supply lines ±1 kV line to line ±1 kV line to line ±0.5 kV line to line ±0.5 kV line to line 0% UT (100% dip in UT) for 0.5 cycle 0% UT (100% dip in UT) for 0.
d = 0.70√P 800MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range4. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE: UT is the a.c.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (M) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Testing • • • • • • • • • • IEC 60601-1 ANSI ES 60601-1 IEC 60601-1-11 CENELEC EN 60601-1 CAN/CSA-C22.2 No. 60601-1 CENELEC EN 60601-1-2 ETSI EN 301 489-1 ETSI EN 301 489-17 ETSI EN 300-330 CISPR 11 25 © 2019 Endotronix® Inc.
Definition of Symbols 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. Manufacturer’s batch code so that the batch or lot can be identified. Manufacturer’s serial number so that a specific medical device can be identified. Authorized representative in the European Community. Need for the user to consult the instructions for use.
Device should be attached to direct current source. Device should be attached to alternating current source. The myCordella™ Patient Reader operates using lithiumion batteries. Lithium-ion batteries should not be crushed or burned. Equipment meeting the safety requirements specified for Class II equipment according to IEC 61140. Type BF applied part complying with IEC 60601-1. IPN1N2 IP21 IP22 Manufacturer-determined degree of particle and water ingress protection, where...
Cordella, myCordella, and Endotronix are trademarks of Endotronix, Inc. ©2019 Endotronix, Inc. All rights reserved 28 © 2019 Endotronix® Inc. 100469-00 Rev.
