Part number:
OXY-2-DUR-IFU-1 Rev A
CONFIDENTIAL
Page 17 of 26
5.4.2
Device Dropped Mode
The Intra.Ox™ contains an accelerometer that detects if the system is dropped.
If it is dropped
on a non-sterile surface, the device cannot continue to be used. However, the Intra.Ox may
continue to be used if dropped onto a sterile surface, such as a table within the sterile field in the
operating room.
In this mode, the device will display the following guidance:
It will then ask the user to re-do the optical QC target checks outlined in Section 0. Assuming
that the optics are still working properly after the drop, the device will return to its typical
measurement mode.
5.4.3
Sheath Open Mode
If at any time during the procedure the sheath is opened, the device will display the following:
The device should not be used for patient contact while the sheath is open. The device can be
returned to measurement mode by re-closing the sheath.
