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.

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2.11 Table of symbols
Table 2. Table of symbols
Symbol
Meaning
Manufacturer’s Catalogue designation or number
Serial number
Lot number
CE mark in accordance to the European Medical Device Directive
European Union Authorised Representative
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a physician or other licensed health practitioner
Instructions are included and must be followed
Caution or warning
Dispose of this equipment according to local regulations for electrical and
electronic waste disposal
Manufactured by
Drip Proof Equipment-IPX1: The Provizio SEM Scanner enclosure provides
protection against the harmful effects of the ingress of liquids. (IPX1, per IEC
60529)
Type BF Applied Part with IEC-60601-1
Keep away from sunlight
Keep dry
Do not use if the package is damaged and the device inside appears physically
broken, cracked or does not charge and start up following the Instructions
for Use
Temperature limits (example limits shown)
Humidity limits (example limits shown)
Package contents
Single-patient use only
Non-sterile
Medical device

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Provizio SEM Scanner FH and Provizio SEM Scanner S
Set-up
Unpacking and inspection
After the Provizio SEM Scanner is unpacked verify that the scanner has no signs of damage.
Contact Customer Service if there are signs of damage. Figure 4 shows the packaged Provizio
SEM Scanner.
Figure 4 Packaging of components
Follow your institutional policies and procedures regarding recycling and disposal of packaging.
Charging the Device
Make sure there is no foreign material in the Charging Hub slot before placing the
scanner in the Charging Hub.
NOTE: The Provizio SEM Scanner and/or Charging Hub may be warm to the touch during
charging. This is normal operation.

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Charge the Provizio SEM Scanner before using it for the first time to at least four bars (five bars
is the maximum). Follow the steps below to charge the scanner:
1. The Charging Hub is packaged with an
AC to DC wall adapter (Figure 5). The
adapter comes with several regional
pin configurations. Select the
configuration suitable for your
institution, insert into the face of the
adapter and twist to the right.
A “click” indicates that the pins are
inserted and locked.
2. Check that the pins are locked by
gently turning to the left. The pins
should not disengage from the
adapter.
Figure 5 AC/DC Wall Adapter
3. Insert the cylindrical connector of the
adapter into the back of the Charging
Hub.
4. Plug the power adapter into the
power outlet.
5. Check that the light on the front of
the Charging Hub is illuminated
orange.
Place the scanner into the Charging
Hub.
6. Check that the light has started
flashing green. If the light is not
flashing green, then the Provizio SEM
Scanner may not be positioned in the
cradle correctly. Orange means an
error has occurred.
7. When positioning the Charging Hub,
make sure the hub is placed in a way
that makes it difficult to disconnect
the Provizio SEM Scanner
Figure 6 Correct Positioning of the Provizio
SEM Scanner on the Charging Hub

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8. The touchscreen is disabled while the
scanner is in the Charging Hub. The
display shows the status of the data
upload and the battery charge level.
(Figure 7).
Figure 7 Display during charging
9. NOTE: The indicator light may remain
on for a short time when the Charging
Hub has been disconnected from the
mains, This is normal behaviour.
10. Refer to Section 6.3 for more
information regarding the upload of
patient data.
Connecting the Provizio SEM Scanner to Institution Wireless Networks
Please refer to your institutions Information Technology Department and the Gateway User
Manual and the Provizio Maintenance Screen Manual for instructions on connecting the Provizio
SEM Scanner to your network.

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Provizio SEM Scanner FH and Provizio SEM Scanner S
Operation
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.
Both versions of the scanner operate in the same manner, with the same modes, methods of
scanning and clinical interpretation. The Provizio SEM Scanner S has the additional steps of
installing and removing the single-use sensor. These steps will be noted as “S only” in this
manual.
See Section 7 for cleaning and disinfection procedures.

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Key Features
Figure 8 Key features of the Provizio SEM Scanner S (left) and Provizio SEM Scanner FH
(middle)
Key controls and icons
The following tables describe the controls and icons used throughout this manual and the
Provizio SEM Scanner System.
Table 3 Physical controls
Control
Name
Description
Action button
Turns the scanner ON and OFF

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Table 4 Mode selection controls
Control
Name
Description
Settings
Enters the setting and configuration screens
Automatic upload
Enters barcode scanning (if available) and automatic
upload mode
Manual charting
Enters manual charting mode
Manual patient ID
Enters manual patient ID entry
Training
Enters training and research mode
Table 5 Navigation controls
Control
Name
Description
Home
Return to home and start a new scanning session
Next screen
Go to the next screen
Previous screen
Go to the previous screen
Select
Select body area
Body area
Return to body area selection
Delete
On body area selection screen –deletes
measurements for this body area
On scanning screens –deletes last reading
OK
Accept setting/selection and

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Table 6 Other controls
Control
Name
Description
Sound
Enter sound setting screen
Refresh
Clears the current set of scans and delta in training
mode
Table 7 Battery level icons
Control
Name
Description
Battery indicator
Scanner docked but not charging
Battery indicator
Battery level low
Battery indicator
Intermediate battery levels
Battery indicator
Intermediate battery level, minimum for initial
device
Battery indicator
Battery full
Table 8 Data upload icons
Control
Name
Description
Data upload
Data upload in progress
Data upload
Data upload complete
Data upload
Data upload failed
Table 9 Other icons
Control
Name
Description
Calibration failure
Scanner self-calibration has failed

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Turning the Provizio SEM Scanner ON
The Provizio SEM Scanner 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.
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. A session is defined as scanning the sacrum, left heel and the right heel for the
same patient.
Do not attempt to clean or disinfect a contaminated single-use sensor.
Follow the steps below to start a session with either version of the Provizio SEM Scanner:
1. Do not touch the sensor area (Figure 9) of the scanner during start up as the scanner is
performing a self-calibration and touching the sensor could invalidate the results. There
is no danger of electric shock or damage to the scanner. Restart the scanner by turning it
off and on again if the sensor has been touched during start up.
Figure 9 Provizio SEM Scanner Sensor
2. If the scanner is in the Charging Hub, remove the Provizio SEM Scanner from the Charging
Hub. The unit should power on automatically. If the screen is dark, press and hold the
Action button ( ) until the screen illuminates.
3. If the scanner is not in the Charging Hub, press and hold the Action button ( ) until the
screen illuminates.
4. Check that the scanner has no visible damage or sharp edge.
NOTE: DO NOT USE if the scanner is broken or any damage or sharp edges are found.
5. If required, clean and/or disinfect the unit per Section 7.
After turning on the Provizio SEM Scanner the splash screen will be displayed (Figure 10).

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Figure 10 Provizio SEM Scanner Splash Screen
Touching the Settings button ( ) enters the setting and configuration screens, allowing the
user to configure the wireless and other settings of the scanner.
Touching the Language button( ) will allow you to change language.
After a few seconds the scanner will progress forward in the workflow.
Sleep mode
During a period of inactivity, the unit may turn dark in sleep mode to save power. In sleep mode,
the unit will not obtain readings and the screen will be off.
A scanner in sleep mode may be brought back to action mode by pressing the action button. If a
scanning session was underway, the scanner will return to the screen the user was last on and
resume operation from that point.
Install the Single-Use Sensor - S only
This section is applicable only to the Provizio SEM Scanner S.
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. A session is defined as scanning the sacrum, left heel and the right heel for the
same patient.
The sensor installation screen (Figure 11) will be displayed, prompting the installation of the
single-use sensor.