Use Instructions

Instructions For Use | 4140 | © 2018 Endotronix Inc.
100474-00 Rev 1
13. Inspection & Cleaning Instructions
Inspect the CalEQ system regularly. If any of the inspection checkpoints
apply, please contact Customer Support.
Inspection Checklist
• Power cords are not frayed or connected to unauthorized
equipment. If there is a frayed power cord or if the unit is attached
to unauthorized equipment, unplug the unit and notify Customer
Support to obtain a new one.
• Cables are properly attached and in good condition.
• All accessories are securely attached.
• Components are not in or near water.
• Components have not been moved to an unsuitable location.
• CalEQ power supply should not be covered.
• If any component has been dropped or damaged, call Customer
Support. Qualified service personnel must inspect any dropped or
damaged units before they are assigned for use.
Cleaning
• Clean the system components after each use.
• Shut down the CalEQ, and remove the Reader before cleaning or
disinfecting.
• Turn off the Reader by pressing and holding the small switch at the
base for several seconds.
• To clean, wipe the surfaces with Super Sani-Cloth wipes or
equivalent cleaner.
• DO NOT disassemble. Clean only the surfaces of the Reader, Docking
Station, and CalEQ.
• DO NOT immerse any component in any liquid.
• DO NOT spray liquids directly on any component – use a pre-
moistened cloth.
• DO NOT autoclave.
• DO NOT sterilize with ethylene oxide.
14. Troubleshooting
14.1 Implant Procedure & Delivery System
• If the Stability Sheath becomes disconnected from the Torque
Catheter during the procedure, reconnect the Stability Sheath to the
Torque Catheter and hand tighten the Torque Luer connection to
stabilize.
• If the decision is made not to deploy the Cordella Sensor after it
has been inserted through the introducer sheath, slowly retract
the Delivery System until the Cordella Sensor is in contact with the
distal tip of the introducer. Almost the entire length of the Delivery
System will be removed, and the Cordella Sensor will catch or snag
on the introducer tip. At this point, rotate the handle of the Delivery
System while keeping it in slight tension (DO NOT ACTIVELY PULL).
After a minimum of 5 rotations of the handle, the Cordella Sensor
should have corkscrewed into the distal portion of the introducer
and it will be safe to retract the Delivery System and Cordella
Sensor slowly until they are fully removed. If high resistance is met
or the introducer is being dislodged, insert the Delivery System
approximately 5 mm into the introducer and repeat the removal
procedure steps listed above.
• If rotational placement of the Cordella Sensor in the target segment
is difficult to achieve (e.g. excessive rotation), try incremental
application of torque (i.e. “ratcheting”) rather than continuously
increasing application of torque to the Torque handle.
• If rotating the Cordella Sensor while in target vessel is difficult, you
may retract the system into a larger vessel, then rotate to the desired
orientation, then advance into position in the target segment.
• If difficulty is experienced advancing the Delivery System through
the heart structures, retract the system proximal to the right atrium
and apply torque to the handle to rotate the Cordella Sensor such
that it is on the inner curve of the pathway to the right pulmonary
artery.
14.2 Pairing and Interrogating the Cordella Sensor
• If no information is displayed after attempting to scan the QR
barcode:
1. Check that the red barcode aimer circle is illuminated. If the
aimer is not illuminated, check that the power cord for the