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1.
Warnings and Safety Precautions
The SEM Scanner 200 has been designed and constructed in accordance with the European
Medical Device Directives, applicable U.S. 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 SEM Scanner
200 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.
WARNINGS:
▪ WARNING: The standard of care should be followed for reducing the risk of developing
pressure ulcers. Readings from the SEM Scanner 200 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: To prevent the spread of infection, the SEM Scanner 200 should be properly
cleaned and disinfected according to the instructions provided in this Instructions for Use
after it is used on a patient.
▪ WARNING: Should the device come in contact with non-sterile surfaces (for example, if
it falls on the floor) it should be cleaned and disinfected before obtaining another patient
reading.
▪ WARNING: Do not attempt to disassemble or otherwise modify the SEM Scanner 200
as this can result in unintended hazards. The SEM Scanner 200 can only be serviced by
the manufacturer (Bruin Biometrics, BBI) or a BBI Authorized Service Center. Please
contact your BBI Product Specialist or Customer Service regarding any device that is not
functioning correctly.
Page 4 of 36
MULTI-LANG-0123 Rev D,
OTH-SEM-IFU-
ENGLISH (EU)
January 2018
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