Use Instructions

Instructions For Use | 4342 | © 2018 Endotronix Inc.
100474-00 Rev 1
barcode scanner is connected properly to the handle and the
CalEQ. If the barcode scanner not functioning properly, contact
Endotronix Customer Support.
2. Check that the QR barcode is not smeared, rough, scratched,
exhibiting voids, or coated with frost or water droplets. If the
QR barcode on the Delivery System packaging is damaged,
contact Endotronix Customer Support for assistance. If the QR
barcode from the QR Barcode Report is damaged, re-print the
QR Barcode Report from PMP.
• If the Reader is picked up from the Docking Station but the screen
remains on “Undock Reader,” wait a few minutes for the CalEQ to
recognize that the Reader is undocked. If after a few minutes, the
screen remains on “Undock Reader”, turn off and redock the Reader,
then repeat the procedure with the backup Reader and contact
Endotronix Customer Support post-procedure.
• If the Reader is unable to find the Cordella Sensor signal when
placed on the Delivery System packaging, even after repositioning
the Reader around and to the side of the box, repeat the steps with
a new Delivery System package and contact Endotronix Customer
Support after the procedure.
14.3 Calibrating the Cordella Sensor
• If the Reader does not turn on, as indicated by audio and visual
cues, after pressing and holding the travel button for several seconds,
place the Reader back on the Docking Station, ensuring that the
Docking Station power cord is plugged into the power strip and
the power strip is plugged into an outlet. If the Docking Station LED
flashes, the Reader is not fully charged; the backup Reader should
be used. If the Reader does not turn on, even when charged, use the
backup Reader and contact Endotronix Customer Support after the
procedure.
• If the wrong reference pressure measurement numbers are entered,
go back to the Home Screen and start the calibration workflow from
the beginning.
• If the Reader is picked up from the Docking Station and CalEQ says
“Reader Not Found,” repeat the procedure with the backup Reader
and contact Endotronix Customer Support.
• If the option to “Upload Later” is chosen instead of “Upload to
Cloud,” navigate to Calibration History to upload the calibration data
when desired. To view Calibration History, press the “Menu” button
in the bottom left corner, then the “Calibration History” button.
Alternatively, the next time a calibration is done, selecting “Upload to
Cloud” will upload all data that has not been previously uploaded.
• If the computer application starts getting choppy or lags, log out
of the program and log back in. Log out by navigating to the Menu,
pressing the “End Session” button, then pressing “Yes” to confirm.
• If the CalEQ finds a signal strength above 75% but does not
transition to calibration, dock the Reader and undock when
prompted. CalEQ will proceed to the Calibrate Sensor screen, where
calibration can begin again.
• If the Reader is having difficulty taking a reading, move patient
monitoring systems, cell phones, pagers, and other equipment that
could cause interference at least 1m away from the patient’s chest.
o If the Reader continues to have difficulties, calibration can be
completed after the implant procedure. Record the reference
measurements during the procedure, then follow the calibration
steps later. It is important that the patient’s position during post-
procedure calibration closely matches their position when the
reference measurements were taken.
15. Useful Life
The tested useful life of the Cordella Sensor is ten (10) years. The tested
service life of the Reader and Docking Station is one year, and the tested
service life of CalEQ is five years.
16. Contact Us
Questions or concerns regarding setup, use, unexpected operation or
events, and general inquiries can be directed to the contact information
below:
Endotronix Customer Support
1800 814 282 (IE)
[phone] (UK)
[phone] (BE)
[e-mail]