ENGLISH OUS indications
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OTH-SEM-IFU-OUS-0359 Rev I
General
2.1
Nomenclature
Pressure ulcers also are called pressure injuries, decubitus ulcers, bed sores or pressure sores.
2.2
Indications for use
The Provizio SEM Scanners are intended as an adjunct to the current standard of care for the
detection of deep and early-stage pressure-induced injuries/ulcers by health care professionals.
2.3
Device description
The Provizio SEM Scanner is a hand-held, portable device that consists of a single electrode
sensor, an integrated pressure sensor and hardware and software to run a user interface device
screen that displays the device status, battery status, SE
M Value and SEM Delta (“SEM∆”).
The Provizio SEM Scanner is pre-calibrated and is provided with a Charging Hub and power
supply for recharging the scanner.
The Provizio SEM Scanner assesses changes in electrical capacitance of tissue and expresses the
result in a SEM Value of 1.0 to 4.5. SEM Value is unitless (not an International System of Units
measurement). The Provizio SEM Scanner displays a SEM
value after a minimum of three (3)
SEM Values have been measured. The reported SEM
Δ
is used as an adjunct to the standard of
care when assessing the heels and sacrum of patients who are at increased risk for pressure
injuries/ulcers. See Section 8 for details of interpretation of the SEM
values.
Figure 1 Provizio SEM Scanner S showing scanner and charging hub
The scanner can transmit collected SEM Values and SEM
, when associated with a valid patient
identification number to a centralised, in-institution, data server for later review. Refer to the
Gateway User Manual for more information.
