ENGLISH (US)
Page 4 of 28
OTH-SEM250-0356 Rev D
1.
Warnings and Safety Precautions
The Provizio SEM Scanner and Provizio SEM Scanner S has been designed and constructed in
accordance with applicable United States (US) regulations and requirements, as well as U.S. and
international standards for operation of electrical equipment, electromagnetic compatibility, and
stipulated safety requirements.
Improper use or handling, however, can result in damage and/or injury. To prevent damage to
the equipment, please read these operating instructions carefully before using your Provizio
SEM Scanner system. Keep these instructions in a safe place. Follow the instructions below to
ensure safe and trouble-free operation of your system.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician or
other licensed health practitioner.
1.1.
Warnings
WARNING: The standard of care should be followed for reducing the risk of
developing pressure ulcers. Readings from the Provizio SEM Scanners can be used to
support increased intervention; but should never be the basis for decreasing
intervention.
WARNING: This device is not intended to be used for detecting or diagnosis of
pressure ulcers.
WARNING: Do not use the Provizio SEM Scanners on broken or otherwise
compromised skin.
WARNING: Only use with Provizio System components.
WARNING: To prevent the spread of infection, the Provizio SEM Scanners should be
properly cleaned and disinfected according to the instructions provided in this
document after it is used on a patient.
WARNING: To prevent cross-contamination of patients, use a new, unopened single-
use sensor per patient, per session. Multiple anatomic locations may be scanned using
the same sensor in one session, however, ensure a new sensor is used for each new
session.
