ENGLISH OUS indications
Page 6 of 50
OTH-SEM-IFU-OUS-0359 Rev I
sensor in one session. Make sure, however, that a new sensor is used for each new session.
A session can be defined as scanning the sacrum, left heel and right heel for the same patient.
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WARNING: Do not attempt to clean or disinfect a contaminated single-use sensor.
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WARNING: Clean and disinfect the device before obtaining another patient reading if it
comes into contact with contaminated surfaces (for example, if it falls on the floor).
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WARNING: Do not attempt to disassemble or otherwise modify the Provizio
SEM Scanners because this can result in unintended hazards. The Provizio SEM Scanner
System can only be serviced by the manufacturer (Bruin Biometrics LLC) or a Bruin
Biometrics LLC Authorised Service Centre. Please contact your Product Specialist or
Customer Service regarding any device that is not functioning correctly.
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WARNING: This equipment must be connected only to the supply mains with protective
earth to avoid the risk of electric shock.
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WARNING: The Provizio SEM Scanners should not be used in the presence of flammable
anaesthetic agents to avoid the risk of explosion.
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WARNING: The Provizio SEM Scanner S will not operate correctly without first installing
a single-use sensor connector.
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WARNING: Make sure there is no foreign material in the Charging Hub slot before
placing the scanner in the Charging Hub.
Cautions
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CAUTION: Examine the Provizio SEM Scanner for damage or sharp edges before each
use. Please contact your Product Specialist or Customer Service if any damage or sharp
edges are found. Do not attempt to use the device.
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CAUTION: Make sure the power cord is plugged into the supply mains and the Provizio
SEM Scanner is fully charged before use.
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CAUTION: Do not immerse the Provizio SEM Scanner. Immersion may damage the
scanner and prevent it functioning normally.
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CAUTION: Ensure that the sensor connector is completely dry before attaching a
single-use sensor to the device.
Note
to the user and/or patient that any serious incident that has occurred in relation to
the device should be reported to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established.
