Use Instructions

Instructions For Use | 3938 | © 2018 Endotronix Inc.
100474-00 Rev 1
10. Maintenance and Storage
10.1 Environmental Information
Store the Delivery System and Cordella Sensor in standard hospital storage
conditions. Keep dry and out of sunlight.
The CalEQ computer, Docking Station, and backup Docking Station should
remain plugged into the power strip. The Reader and backup Reader
should remain in the Docking Stations when not in use. Reference the
Equipment Specifications in Appendix B for specific storage conditions.
The Cordella Sensor and Delivery System are sterilized in a Tyvek pouch.
Tyvek pouches are stored in primary boxes. The primary boxes containing
the sterile Tyvek pouch should be stored in a clean, dry place with other
sterile inventory.
Ensure all parts are clean and dry prior to storage.
10.2 Replacement and Repair
The Cordella Pulmonary Artery Sensor System does not require
maintenance and contains no user serviceable parts . If an issue with the
system appears to require maintenance, contact Endotronix Customer
Support.
To maintain applicable warranties and function, Endotronix requires that
only authorized personnel perform repairs. There are no user serviceable
parts. Repairs made by unauthorized personnel will invalidate your
warranty. For product warranty information, please contact Endotronix.
WARNING: Do not attempt to modify, disassemble, or
otherwise alter any of the system components. If the
system appears to be damaged, contact Endotronix
Customer Support.
If there are defects or damage to any system component, including power
accessories, request a replacement from Endotronix and follow the RMA
process (described below) as requested by Customer Support.
Software configuration of the CalEQ can only be performed by Endotronix
authorized personnel.
11. Disposal
The Cordella Sensor and Delivery System are single use devices. Once the
Cordella Sensor has been deployed from the Delivery System, dispose of
the Delivery System following standard hospital protocols for disposal of
biohazardous materials. If the Cordella Sensor is removed from the patient
for any reason (death, adverse event, etc.), then it should be contained
and shipped to Endotronix following standard protocols for biohazardous
materials. If there is an adverse event or device failure related to the Delivery
System, the affected component should be shipped to Endotronix.
The Reader, Docking Station and CalEQ devices may contain lithium ion
batteries, which should not be discarded with the municipal waste. The
Reader and Docking Station should not be disposed of and instead should
be returned to Endotronix through the RMA process detailed below.
12. Return Materials Authorization (RMA)
If Customer Support requests that the equipment be returned, please
follow the directions below.
1. Check off each item on the equipment return list and carefully pack
the equipment in the original shipping box or equivalent with its
original protective packaging materials.
2. Include the RMA number given to you by Customer Support on the
outside of the shipping container. Ship all equipment and signed
equipment return list to:
RMA #
Customer Support Department, Repairs Endotronix, Inc.
Endotronix, Inc.
815 Ogden Ave.
Lisle, IL 60532
U.S.A.