Use Instructions

Instructions For Use | 1716 | © 2018 Endotronix Inc.
100474-00 Rev 1
• 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. Signs of mean pressure measurement error
include: gradual mean pressure changes without a corresponding
proportional change in pulse pressure (systolic-diastolic pressure),
negative mean pressures, acute shift in mean pressures, and non-
physiologic acute shift in mean pressures persistent over multiple
measurements. If any of these signs are observed, temporarily suspend
use of the pressure information for management of the patient and
contact Customer Support for further assistance. Baseline (mean
pressure) recalibration may be necessary to continue use of the system.
• Activities that may expose the patient to pressure extremes may affect
device performance. If the patient plans to SCUBA dive, please contact
Customer Support.
• Accuracy of the Cordella Pulmonary Artery Sensor System is slightly
affected by large changes in elevation between the initial baseline
calibration and subsequent measurements. Readings may lose accuracy
when taken at >2000m of elevation.
• The CalEQ should not be used in the sterile field.
• DO NOT expose any components of myCordella to water or liquids.
Contact Customer Support 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 comprimised, contact Endotronix Customer
Support
• Accuracy of the Cordella Pulmonary Artery Sensor System is affected by a
change in body temperature (<-3mmHg/∆°C).
3.4 Potential Adverse Events
Potential risks associated with the overall procedure include potential access
complications associated with standard right heart catheterization, the
potential risks of conscious sedation, and the use of angiography:
• Allergic reaction
• Arrhythmias
• Bleeding complications (which may require transfusion)
• Cardiac arrest
• Chest pain
• Death
• Device embolization/migration
• Emergent or urgent cardiac surgery necessitated by the device or
procedure
• Endocarditis or device infection
• Entry site complications (e.g., hematoma, dissection)
• Gastrointestinal bleed
• Haemoptysis
• Hypo or hypertension
• Infection or fever
• Peripheral embolism/thrombus
• Pulmonary embolism/pulmonary occlusion
• Pseudoaneurysm of the vein
• Radiation exposure
• Reaction to contrast media/medication
• Renal insufficiency or failure
• Respiratory distress or failure (breathing problems)
• Sepsis
• Valvular injury (tricuspid and/or pulmonary)
• Vascular complications (e.g., venous dissection, perforation, rupture,
arteriovenous fistula,)
• Vessel trauma which may require surgical repair
• Worsening heart failure
Precautions (Cont.)