Instructions For Use
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© 2018 Endotronix Inc.
100474-00 Rev 1
7. On the confirmation screen,
ensure all Cordella Sensor and patient
information is correct.
DO NOT
scan visibly damaged barcodes; use a different Delivery
System package.
4.3 Delivery System Package Inspection
1.
Inspect the Delivery System package carefully for any damage before
opening.
2.
Ensure the “Use By” Date on the product label has not passed. The
implant of the Cordella Sensor is not permitted after its expiration
date.
3.
The primary box contains one Cordella Sensor tied down to the distal
end of the Delivery System and the product documentation.
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
Downturn
Right PA
Main Bifurcation
Left PA
1.
Set up the patient for venous access. Position the sterile drape to allow
for non-sterile access to the patient’s chest. Position ECG leads as far
away from the right side of the patient’s chest and side as possible.
Endotronix recommends limb ECG leads.
2.
Gain access to the patient’s vein and expand to allow for a 14 French
introducer. Begin a typical right heart catheterization by floating a
pulmonary artery catheter (PAC) or steering a guide catheter to the
right pulmonary artery.
3.
Introduce a 0.018” or 0.025” diameter guidewire through the lumen
of the catheter and place the distal tip of the guidewire distal to the
target implant location.
