ENGLISH OUS indications
Page 5 of 50
OTH-SEM-IFU-OUS-0359 Rev I
Warnings and safety precautions
The Provizio
®
SEM Scanner FH and Provizio
®
SEM Scanner S have been designed and constructed
in accordance with applicable United States (US) regulations and requirements, as well as US 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
achieve safe and trouble-free operation of your system.
: Federal (US) law restricts this device for sale by or on the order of a physician or other
licensed health practitioner. The Provizio
®
SEM Scanner FH and Provizio
®
SEM Scanner S have
been designed and constructed in accordance with applicable European Medical Device
Directives and United States (US) regulations and requirements, as well as US and international
standards for operation of electrical equipment, electromagnetic compatibility and stipulated
safety requirements.
Warnings
▪
WARNING: The standard of care should be followed to reduce the risk of developing
pressure injuries/ulcers. Readings from the Provizio SEM Scanners can be used to support
increased intervention; but should never be the basis for decreasing intervention.
▪
WARNING: Do not use the Provizio SEM Scanners on broken or otherwise
compromised skin.
▪
WARNING: Use only with Provizio SEM Scanner System components.
▪
WARNING: The Provizio SEM Scanners should be cleaned and disinfected properly
according to the instructions provided in this document after it is used on a patient to
prevent the spread of infection.
▪
WARNING: 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
