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OTH-SEM-IFU-OUS-0359 Rev I
Cleaning and disinfection
Do not reuse single-use sensors for multiple patients or multiple sessions.
The Provizio SEM Scanner should be cleaned and disinfected properly according to the
instructions provided in these Instructions for Use after it is used on a patient to prevent
the spread of infection.
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
sensor in one session. Make sure, however, that a new sensor is used for each new session.
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).
Do not immerse the Provizio SEM Scanner. Immersion may damage the scanner and
prevent it functioning normally.
Cleaning and disinfection overview
Bruin Biometrics LLC recommends manual cleaning and disinfecting the Provizio SEM Scanner
between patients by using nonabrasive US EPA Registered cleaning and disinfection wipes
described in the instructions below. The Provizio SEM Scanner should never be exposed to the
chemical agents listed in the Warranty and Disclaimer section. Use of these agents will void the
product warranty and could damage the scanner.
The Provizio SEM Scanner should be cleaned and disinfected using nonabrasive cleaning and
disinfection wipes containing intermediate-level chemical agents. Cleaning and disinfection are
sequential processes. To achieve cleaning and disinfection requirements for intermediate risk
level devices, Bruin Biometrics LLC tested the use of wipes designed to perform both processes:
a cleaner and chemical disinfectant in one wipe form.
The entire body of the scanner is capable of being cleaned and disinfected safely, including the
Sensor Connector (Provizio SEM Scanner S only) and the Sensor (Provizio SEM Scanner FH only).
Single-use sensors should be disposed of following institutional policies and procedures for
patient-contacting materials.
Remove any cleaning or disinfection product removal per the manufacturer’s instructions.
Most healthcare-
use wipes such as CaviWipe™ by Metrex Research are designed to both clean
and disinfect.
CaviWipe™ was tested by Bruin Biometrics LLC.
