BRUIN BIOMETRICS Provizio SEM Scanner S User manual

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Provizio®SEM Scanner S
Provizio®SEM Scanner FH
User manual

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Table of Contents
Warnings and safety precautions .........................................................................................................5
Warnings.......................................................................................................................................5
Cautions ........................................................................................................................................6
General.......................................................................................................................................................7
2.1 Nomenclature..............................................................................................................................7
2.2 Indications for use.......................................................................................................................7
2.3 Device description......................................................................................................................7
2.4 Provizio SEM Scanner.................................................................................................................8
2.5 Additional Provizio SEM Scanner components ....................................................................9
2.6 OEM Parts Kit..............................................................................................................................9
2.7 Contraindications........................................................................................................................9
2.8 Intended user profile..................................................................................................................9
2.9 Adverse effects ............................................................................................................................9
2.10 Warranty.................................................................................................................................... 10
2.11 Table of symbols....................................................................................................................... 11
Provizio SEM Scanner FH and Provizio SEM Scanner S Set-up .................................................. 12
Unpacking and inspection....................................................................................................... 12
Charging the Device................................................................................................................ 12
Connecting the Provizio SEM Scanner to Institution Wireless Networks................. 14
Provizio SEM Scanner FH and Provizio SEM Scanner S Operation........................................... 15
Key Features ............................................................................................................................. 16
Key controls and icons ........................................................................................................... 16
Turning the Provizio SEM Scanner ON .............................................................................. 19
Sleep mode ................................................................................................................................ 20
Install the Single-Use Sensor - S only .................................................................................. 20
4.5.1 Installing the Sensor................................................................................................................. 21
Select mode of operation....................................................................................................... 22

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4.6.1 Automatic Upload mode........................................................................................................ 23
4.6.2 Manual Charting mode............................................................................................................ 24
4.6.3 Training mode........................................................................................................................... 24
4.6.4 Manual Patient ID Entry.......................................................................................................... 25
Select Body Location............................................................................................................... 25
Taking measurements .......................................................................................................................... 27
General....................................................................................................................................... 27
Taking measurements at the sacrum................................................................................... 28
Taking measurements at either heel.................................................................................... 29
Finishing the Session............................................................................................................................. 31
Remove the Single-Use Sensor - S only.............................................................................. 31
Clean and disinfect................................................................................................................... 31
Data upload ............................................................................................................................... 31
Turning the Scanner OFF....................................................................................................... 32
Cleaning and disinfection..................................................................................................................... 33
Cleaning and disinfection overview...................................................................................... 33
Scanner cleaning instructions ................................................................................................ 34
Scanner disinfection instructions.......................................................................................... 35
7.3.1 Disinfection steps using CaviWipe....................................................................................... 35
Cleaning the Charging Hub.................................................................................................... 36
Clinical interpretation.......................................................................................................................... 38
Deriving SEM Scanner Delta (∆) Values.............................................................................. 38
8.1.1 SEM200-008 –Study Population........................................................................................... 38
8.1.2 SEM200-008 –Results............................................................................................................. 39
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ................................ 42
Electromagnetic Environment ............................................................................................... 42
Electromagnetic Immunity...................................................................................................... 43
Separation distance.................................................................................................................. 45
Specifications.......................................................................................................................................... 46

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Disposal................................................................................................................................................... 47
Packaging .................................................................................................................................... 47
Single-use sensor...................................................................................................................... 47
Provizio SEM Scanner.............................................................................................................. 47
Troubleshooting.................................................................................................................................... 48

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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

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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.
▪WARNING: Do not attempt to clean or disinfect a contaminated single-use sensor.
▪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).
▪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.
▪WARNING: This equipment must be connected only to the supply mains with protective
earth to avoid the risk of electric shock.
▪WARNING: The Provizio SEM Scanners should not be used in the presence of flammable
anaesthetic agents to avoid the risk of explosion.
▪WARNING: The Provizio SEM Scanner S will not operate correctly without first installing
a single-use sensor connector.
▪WARNING: Make sure there is no foreign material in the Charging Hub slot before
placing the scanner in the Charging Hub.
Cautions
▪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.
▪CAUTION: Make sure the power cord is plugged into the supply mains and the Provizio
SEM Scanner is fully charged before use.
▪CAUTION: Do not immerse the Provizio SEM Scanner. Immersion may damage the
scanner and prevent it functioning normally.
▪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.

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General
2.1 Nomenclature
Pressure ulcers also are called pressure injuries, decubitus ulcers, bed sores or pressure sores.
2.2 Indications for use
The Provizio SEM Scanners are intended as an adjunct to the current standard of care for the
detection of deep and early-stage pressure-induced injuries/ulcers by health care professionals.
2.3 Device description
The Provizio SEM Scanner is a hand-held, portable device that consists of a single electrode
sensor, an integrated pressure sensor and hardware and software to run a user interface device
screen that displays the device status, battery status, SEM Value and SEM Delta (“SEM∆”).
The Provizio SEM Scanner is pre-calibrated and is provided with a Charging Hub and power
supply for recharging the scanner.
The Provizio SEM Scanner assesses changes in electrical capacitance of tissue and expresses the
result in a SEM Value of 1.0 to 4.5. SEM Value is unitless (not an International System of Units
measurement). The Provizio SEM Scanner displays a SEMvalue after a minimum of three (3)
SEM Values have been measured. The reported SEMΔis used as an adjunct to the standard of
care when assessing the heels and sacrum of patients who are at increased risk for pressure
injuries/ulcers. See Section 8 for details of interpretation of the SEMvalues.
Figure 1 Provizio SEM Scanner S showing scanner and charging hub
The scanner can transmit collected SEM Values and SEM, when associated with a valid patient
identification number to a centralised, in-institution, data server for later review. Refer to the
Gateway User Manual for more information.

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2.4 Provizio SEM Scanner
The Provizio SEM Scanner System is provided in three versions:
•Provizio SEM Scanner S with a separately supplied single-use, non-sterile sensor and
having manual patient ID entry only;
•Provizio SEM Scanner FH with the sensor connector integrated into the scanner and
having both manual patient ID entry and scanning patient ID barcodes; and
•Provizio SEM Scanner S with a separately supplied single-use, non-sterile sensor and
having both manual patient ID entry and scanning patient ID barcodes.
The Provizio SEM Scanner FH is distinguished by the orange concentric rings on the sensor
connector.
The Provizio SEM Scanner S is distinguished by the blue sensor with three gold connectors.
The Provizio SEM Scanner S will not operate correctly without first installing a single-
use sensor connector.
Ensure that the sensor connector is completely dry before attaching a single-use sensor
to the device.
Figure 2 Provizio SEM Scanner FH

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Figure 3 Provizio SEM Scanner S
2.5 Additional Provizio SEM Scanner components
The Provizio SEM Scanner is packaged with a Charging Hub, power supply that is used when
charging the scanner and provides a base for the scanner when not in use. The internal
battery is recharged by wireless power transfer when the scanner is placed in the Charging
Hub. See Section 3.2 for charging instructions.
2.6 OEM Parts Kit
In the event of misplacing or losing the components provided with the Provizio SEM Scanner,
an OEM Parts Kit is available for purchase to replace these items. The Kit includes a Charging
Hub, power cord, plug adaptor bag (with 5 regional adaptors) and Instructions for Use (IFU)
in cardboard packaging. Contact your Customer Service provider for more information.
2.7 Contraindications
Not to be used on broken skin and intended for use on adult population only.
2.8 Intended user profile
The system is intended for use by healthcare professionals.
2.9 Adverse effects
There are no known adverse effects using the Provizio SEM Scanner.

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2.10 Warranty
This manual is intended to provide instructions on the proper use of the Provizio SEM Scanner.
It should be used in conjunction with the appropriate training.
To request repair or replacement under warranty, purchasers should contact their local
Customer Service provider. Warranty conditions may differ in some countries. Contact your
Customer Service provider for warranty terms.
Using the instrument in a manner other than that described in this manual may result in improper
function. Warranty is limited to defects and materials that can be attributed to a fault or defect
within the Provizio SEM Scanner.
Warranty does not extend to any Warranted Products or parts thereof: (a) that have been
subject to misuse, neglect or accident, (b) that have been damaged by causes external to the
Warranted Product, (c) that have been used in violation of the Bruin Biometrics LLC Instructions
for Use, (d) on which the serial number has been removed or made illegible, (e) that have been
modified by anyone other than Bruin Biometrics LLC or its authorised service centre, unless
authorised prior to such service by Bruin Biometrics LLC, (f) that are equipment sold as used or
(g) that are exposed to agents listed in Table 1, below. Table 1 is not an exhaustive list of agents
which may compromise the integrity of the Provizio SEM Scanner.
Severe effect –NOT recommended
Benzene
Cyclohexane
Kerosene
Nitric Acid –70%
Carbon tetrachloride
Ethyl Chloride
Trichloroethylene
Perchloroethylene
Chlorobenzene
Freon
Lacquer
Toluene
Chloroform
Petrol, unleaded
Naphtha
Xylene
Table 1. Agents that should never be used on the Provizio SEM scanner
Note –no distributor, dealer or other party is authorised to make any warranty on behalf of
Bruin Biometrics LLC or to assume for Bruin Biometrics LLC any other liability with respect to
the Provizio SEM Scanner.
The contents of this User Manual do not constitute a warranty.