User Manual

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© 2019 Endotronix® Inc. 100469-00 Rev. 2
• 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.
Precautions
• Avoid exposing any components of myCordella™ to water or liquids. Contact customer service
for a replacement if any 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 Reader. Any damage to the Reader may result in an inaccurate
reading.
• DO NOT use the Reader if the plastic casing has been damaged, cracked or any component
becomes dislodged.
• If the Reader label becomes compromised, contact Endotronix customer service.
• Accuracy of the Cordella™ PA Sensor System is affected by a change in body temperature (<-
3mmHg/∆°C).
• Accuracy of the Cordella™ PA Sensor System is slightly affected by large changes in elevation
between the initial baseline calibration and subsequent measurements. Readings may lose
accuracy when taken >2000m of elevation.
• The Cordella Sensor is a permanent implant. Removing the implant after implantation is not
recommended.
• The Cordella Sensor may be affected by a change in elevation above or below sea level. If you
plan to travel below sea level or SCUBA dive or extremely high altitudes without
pressurization, please contact customer service.
Patient Privacy and Medical Privacy Standards
All components of the Cordella PA Sensor System have been designed
to comply with patient privacy regulations. Your healthcare providers
organization as well as Endotronix® will ensure that they are also in
complete compliance with privacy and security statutes, as well as the
organization’s policies, procedures, and protocols to respect patient
information and ensure patient privacy at all times.
Endotronix® is not responsible for the use or abuse of patient
information by health care providers.
Implant procedure
Before the Implant Procedure
Prior to the implant procedure, you and your doctor will discuss the
benefits and risks of the procedure and the Cordella PA Sensor