Instructions For Use
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© 2018 Endotronix Inc.
100474-00 Rev 1
4.5 Delivery System & Cordella Sensor Insertion
1.
Catheterization lab staff should assist the implanter in sterile removal
of the Cordella Sensor and Delivery System from the sterile packaging
and record the Sensor Serial Number in the patient’s chart with the
peel and stick label.
2.
Inspect the entire effective length of the Delivery System carefully for
any damage, including kinks, burrs, roughness, or tight connections.
The features of the Delivery System handle are labeled below:
Side Port/
Contrast Injection Site
Release Wire Cap
Handle/Torque Control
Torque Luer
Stability Sheath
surrounding
Torque Catheter
3.
Ensure the Cordella Sensor is tied down correctly by comparing to the
image below.
4.
If the Delivery System or Cordella Sensor appears damaged or
defective, do not use the product and contact Customer Support.
WARNING:
The Cordella Sensor should not be
interrogated by the Reader after removal from the
packaging until the Sensor is implanted.
5.
Remove the stylet from the distal end of the Delivery System and
flush the side port and guidewire lumen with sterile saline using a
hand syringe.
6. Thread the Delivery System over the guidewire through the distal tip
(front-end loading).
7.
Grip the catheter directly behind the Cordella Sensor as shown and
gently push the Cordella Sensor through the introducer. Care should
be taken to push from the back of the Cordella Sensor to minimize
damage and changes to the tiedown configuration.
WARNING:
If touching the Cordella Sensor is necessary,
grab only by the sides and not the top surface as this
may cause Sensor damage.
8. Slowly push the Cordella Sensor through the introducer. If severe
resistance is encountered, stop pushing the Cordella Sensor and
attempt to identify the source of resistance. Proceed cautiously.