Use Instructions

Instructions For Use | 1312 | © 2018 Endotronix Inc.
100474-00 Rev 1
• 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.
• Fluoroscopy is required to perform the implant procedure in order to
visualize the target vasculature and to ensure proper device placement.
• Cordella Sensor should be placed into the patient’s right pulmonary
artery with diameter ≥12 mm and ≤30 mm at the right pulmonary artery
downturn.
• As much as possible, avoid contacting the Cordella Sensor with any
subsequent catheters or wires. When contact is unavoidable (e.g. during
Delivery System withdrawal), take care to avoid disrupting the Cordella
Sensor.
• Avoid vessel wall contact with the Delivery System whenever possible.
Too much or too forceful contact may perforate the vessel.
• DO NOT advance or retract the Delivery System without a guidewire in
place.
• Following device implantation, all future right heart catheterizations
(RHCs) will require fluoroscopy to reduce the likelihood of catheter or
guidewire contact with the Cordella Sensor.
• DO NOT pull the release wires prior to intended deployment. Any
strain on the release wires may loosen the Cordella Sensor tie down
mechanism.
• DO NOT mishandle the Delivery System or use it if the packaging or
any components are not sterile, have been opened or are damaged (i.e.
kinked or stretched), or the expiration date has elapsed. Do not attempt
to repair a damaged Delivery System. Replace it with another Delivery
System from inventory 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 attempt to modify, disassemble, or otherwise alter the Cordella
Pulmonary Artery Sensor System.
• During the implant procedure, there should be a continuous heparin drip
to prevent clotting.
• DO NOT expose the Cordella Sensor to therapeutic levels of ultrasonic
energy.
• To avoid risk of electric shock, CalEQ must only be connected to a supply
main with protective earth.
• DO NOT plug additional devices into the CalEQ power strip.
• DO NOT use more than one CalEQ in the same general vicinity at one
time, as use of multiple CalEQs at once may cause them to interfere with
each other.
• After the implatation procedure, it is critical for the patient to adhere to
prescribed anticoagulation and other medications from the physician.
3.2 Warnings: Reader and Docking Station
• The Reader is suitable for home healthcare environments and
professional healthcare facilities except for near active heart failure
hospital equipment and the radiofrequency (RF) shielded room of a
medical electrical (ME) system for magnetic resonance imaging, where
the intensity of electromagnetic (EM) disturbance is high.
• The Reader and Docking Station should not be used adjacent to
or stacked with other equipment. If it is necessary to operate the
components adjacent to or stacked with other equipment, verify that the
system is operating normally in the configuration in which it will be used.
• DO NOT expose any power accessories, the Reader, or the Docking
Station to food or liquids.
• DO NOT use myCordella in the presence of explosive or flammable
anaesthetic agents.
• The Cordella PA Sensor System is not intended for emergency use or real-
time monitoring.
• Power cables may pose a tripping hazard. Be mindful of cords crossing
walkways.
Warnings: Implantation Procedure (Cont.)