ENGLISH OUS indications
Page 21 of 50
OTH-SEM-IFU-OUS-0359 Rev I
Figure 11 Install Sensor
screen
Figure 12 Sensor calibrating
Figure 13 Failed
calibration
After you have installed the sensor (Section 4.5), press the Next Screen ( ). The scanner will
then re-calibrate to the installed sensor (Figure 12). If the scanner fails calibration (Figure 13),
remove the sensor and discard. Try calibration again by installing a new sensor.
Please contact Customer Service if the scanner calibration continues to fail.
4.5.1
Installing the Sensor
Use a new, unopened single-use sensor per patient, per session to prevent cross-
contamination of patients. Multiple anatomic locations may be scanned using the same
sensor in one session. Make sure, however, that a new sensor is used for each new
session. A session is defined as scanning the sacrum, left heel and the right heel for the
same patient.
Do not attempt to clean or disinfect a contaminated single-use sensor.
The single-use sensor is provided in clean, non-sterile individually sealed pouches. Although not
sterile, take care to not contaminate the sensor unnecessarily.
Remove the sensor from the pouch and place it on the Provizio SEM Scanner connector (Figure
14). There is a notch in the sensor and a corresponding tab on the scanner connector to aid
the alignment of the sensor. You will hear and feel a click when the sensor sits correctly on the
connector. Undue force is not required to either install or remove the single-use sensor; the
device has been designed to ensure a simple process but achieve a secure connection once
installed.
