BRUIN BIOMETRICS PROVIZIO SEM SCANNER User manual

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PROVIZIO®SEM SCANNER
GATEWAY SYSTEM
USER MANUAL

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Table of Contents
1. WARNINGS AND SAFETY PRECAUTIONS ..................................................................................................4
1.1. Warnings........................................................................................................................................... 4
1.2. Cautions ............................................................................................................................................ 5
2. GENERAL ......................................................................................................................................................5
2.1. Purpose.............................................................................................................................................. 5
2.2. Requirements ................................................................................................................................... 5
2.3. Nomenclature.................................................................................................................................. 6
2.4. Indications for Use.......................................................................................................................... 6
2.5. Contraindications............................................................................................................................ 6
2.6. Intended User Profile ..................................................................................................................... 6
2.7. Adverse Effects ................................................................................................................................ 6
2.8. Warranty and Disclaimer .............................................................................................................. 6
2.8.1. Exclusions ................................................................................................................................. 7
2.8.2. Disclaimer of Additional Warranties.................................................................................. 7
2.9. Table of Symbols ............................................................................................................................. 8
3. LOGGING IN................................................................................................................................................9
3.1. Enter Credentials ............................................................................................................................ 9
3.2. Select a Language............................................................................................................................. 9
4. CLINICAL ROLE......................................................................................................................................... 11
4.1. Patient List ...................................................................................................................................... 11
4.2. Patient Chart.................................................................................................................................. 12
4.3. Export Data.................................................................................................................................... 13
5. ADMIN ROLE............................................................................................................................................. 15
5.1. Dashboard....................................................................................................................................... 15
5.2. LDAP Mapping ............................................................................................................................... 16
5.3. Data Mapping ................................................................................................................................. 17
5.4. Device Status.................................................................................................................................. 18
5.5. Setup ................................................................................................................................................ 19

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5.6. Settings............................................................................................................................................. 21
5.7. Export Data.................................................................................................................................... 21
6. HANDHELD SUPPORT .............................................................................................................................. 23
6.1. Electromagnetic Environment .................................................................................................... 23
6.2. Electromagnetic Immunity........................................................................................................... 24
6.3. Separation Distance...................................................................................................................... 26
6.4. Specifications .................................................................................................................................. 27
7. TROUBLESHOOTING ................................................................................................................................ 28

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1. Warnings and Safety Precautions
The Provizio SEM Scanner and Provizio SEM Scanner S has been designed and constructed in
accordance with applicable United States (US) 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 Provizio
SEM Scanner 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.
1.1. Warnings
▪WARNING: The standard of care should be followed for reducing the risk of
developing pressure ulcers. Readings from the Provizio SEM Scanners 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: Do not use the Provizio SEM Scanners on broken or otherwise
compromised skin.
▪WARNING: Only use with Provizio System components.
▪WARNING: To prevent the spread of infection, the Provizio SEM Scanners should be
properly cleaned and disinfected according to the instructions provided in this
document after it is used on a patient.
▪WARNING: To prevent cross-contamination of patients, use a new, unopened single-
use sensor per patient, per session. Multiple anatomic locations may be scanned using
the same sensor in one session, however, ensure a new sensor is used for each new
session.

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▪WARNING: Do not attempt to clean or disinfect a contaminated single-use sensor.
▪WARNING: Should the device contact contaminated 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 Provizio SEM
Scanner as this can result in unintended hazards. The Provizio SEM Scanner System 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.
▪WARNING: To avoid the risk of electric shock, this equipment must only be connected
to a supply main with protective earth.
▪WARNING: To avoid the risk of explosion, the Provizio SEM Scanner should not be
used in the presence of flammable anesthetic agents.
▪WARNING: The Provizio SEM Scanner S will not operate correctly without first
installing a single-use sensor head.
▪WARNING: Ensure the is no foreign material in the Charging Base slot before placing
the scanner in the Charging Base.
1.2. Cautions
▪CAUTION: Examine the Provizio SEM Scanner for damage or sharp edges prior to
each use. If any damage or sharp edges are found, please contact Customer Service or
your Product Specialist. Do not attempt to use the device.
▪CAUTION: Ensure the power cord is plugged into the supply main and the device is
fully charged prior to use.
▪CAUTION: Do not immerse the Provizio SEM Scanner. Immersion may damage the
scanner and prevent it functioning normally.
2. General
2.1. Purpose
This document describes how to connect to the Gateway application that is installed at an
institution and guides a user through the various screens.
2.2. Requirements

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2.3. Nomenclature
Virtual Machine: The BBI Webserver VM that is installed on the institution-provided server and
provides a working environment for the BBI Web application.
Pressure ulcers also are called pressure injuries, decubitus ulcers, bed sores or pressure sores.
2.4. Indications for Use
The Provizio SEM Scanner and Provizio SEM Scanner S are intended to be used by healthcare
professionals as an adjunct to the standard of care when assessing the heels and sacrum of
patients who are at increased risk for pressure ulcers.
2.5. Contraindications
Do not use on broken skin.
2.6. Intended User Profile
The system is intended for use by healthcare professionals.
2.7. Adverse Effects
There are no know adverse effects using the scanner.
2.8. Warranty and Disclaimer
This manual is intended to provide instructions on the proper use of the SEM. It should be
used in conjunction with the appropriate training. Bruin Biometrics LLC (BBI) warrants the
Provizio SEM Scanner against defects in materials and workmanship for three (3) years from the
date of purchase from BBI or its subsidiaries. This warranty is given only to the original
purchaser of the SEM Scanner. BBI’s obligation under the warranty is to provide for repair, or
at its option, to provide a replacement product. No other remedy is obligated by this
warranty. All special, incidental, and coincidental damages are excluded.
There are no conditions associated with varnishing, enameling, oxidation and similar protective
finishes, as well as covering with sealing compounds that can re-plasticize at temperatures to be
expected during normal operation.
To request repair or replacement under this warranty, purchasers should contact their local
Customer Service provider.
Warranty conditions may differ in some countries. Contact your Customer Service provider
for warranty terms.
Risk of loss or damage during shipments under this warranty shall be borne by the party
shipping the Product. Products shipped by the Purchaser under this warranty shall be suitably
packaged to protect the Product. If Purchaser ships a product to BBI in unsuitable packaging,
any physical damage present in the Product on receipt and inspection by BBI, and not previously

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reported, will be presumed to have occurred in transit and will be the responsibility of the
Purchaser.
2.8.1.Exclusions
The use of the instrument in a manner different that that described in this manual may result in
improper function. This warranty is limited to defects and materials that can be attributed to a
fault or defect within the SEM Scanner.
This 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 BBI Instructions for Use, (d) on
which the serial number has been removed or made illegible, (e) that have been modified by
anyone other than BBI or its authorized service center, unless authorized prior to such service
by BBI, (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 SEM
Scanner.
Table 1. Agents That Should Never Be Used on the SEM Scanner
Severe Effect –NOT Recommended
Benzene
Cyclohexane
Kerosene
Nitric Acid –70%
Carbon tetrachloride
Ethyl Chloride
Trichloroethylene
Perchloroethylene
Chlorobezene
Freon
Lacquer
Toluene
Chloroform
Gasoline, unleaded
Naphtha
Xylene
2.8.2.Disclaimer of Additional Warranties
No distributor, dealer or other party is authorized to make any warranty on behalf of BBI, or
to assume for BBI any other liability with respect to the SEM Scanner.
The contents of these Instructions for Use do not constitute a warranty.

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2.9. Table of Symbols
Table 2. Table of Symbols
Symbol
Meaning
Manufacturer’s Catalog designation or number
Serial number
Lot Number
CE mark in accordance to the European Medical Device Directive
European Union Authorized 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 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

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3. Logging In
No matter what privileges you have within the Gateway, your login starts the same way.
3.1. Enter Credentials
Open a browser and enter the URL of the Gateway within the institutions’ network. This
should bring up the login screen from the Gateway.
Figure 1 Gateway Login Screen
Enter the username and password that you use for other applications within your institution.
Click on the LOGIN button.
3.2. Select a Language
The Gateway language selection displays the language of the facility setup during configuration
by the Admin. However, it allows each user to select language at their Login for their session.

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Figure 2 User Language Selection
Clicking on LOGIN will take you to the first screen for your Role.

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4. Clinical Role
4.1. Patient List
This screen displays a list of all patients currently under care within your institution.
Figure 3 Patient List Screen
The Patient List displays columns of the Name, Patient ID, date of the last reading, and last
delta values for the Left Heel, Right Heel, and Sacrum. Every column is sortable by clicking on
the heading. There is a SEARCH box to find the name and PID fields. Hovering your mouse
over the “PATIENTS SCANNED IN THE LAST 3 DAYS”brings up a pop-up window
Figure 4 Patients Scanned in Last Three Days
Click on a patient’s name to view the Patient Chart.

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4.2. Patient Chart
The Patient Chart page displays a plot of the delta values over a period of time that can be
selected by the button along the bottom of the page. This example is a 2-week plot. The
orange line is the 0.6 threshold for an actionable delta. The icon legend is shown at the top of
the page.
Figure 5 Patient Chart
Hovering over an icon will display the numeric details of that data point.
Figure 6 Data Point Details
Clicking on an icon will bring up a pop-up with a plot of the SEM values that were taken to
generate this delta value.

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Figure 7 SEM Values For a Data Point
Close the browser window to exit the session.
4.3. Export Data
The Export Data feature allows users to select criteria and Export SEM data in Excel format
for the selected options.
Figure 8a Export SEM Data View
The available filters and options for Data Export are:

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•All Patients or Selected Patients
•Unencrypted or Encrypted Data (Patient ID, Patient Name)
•For Unencrypted data, the following warning will be displayed:
oExported patient data will be UNENCRYPTED. Proper safeguards should be in place
to secure data.
•Filter by Date Range
•Filter by Reading Type (SEM, Right Heel, Left Heel)
•View Data on Screen
•Export Data in CSV format
Clicking on left menu “Export Data” will launch the above screen. Select the desired options
and click on “View Data” to refresh the data on the screen.
“Download CSV” will be enabled once you have “Refreshed Data” by clicking on “View Data”.
Clicking on “Download CSV” will download the file (csv or zip) on your computer hard drive in
the download folder.

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5. Admin Role
The Admin Menu lists several options to allow management of Dashboard, Devices,
Language Settings, Database Setup, and Data Mapping.
Figure 9 Admin Menu
5.1. Dashboard
The Dashboard shows the percentage of patients who are above and below the 0.6 threshold.

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Figure 10 Dashboard Chart
The Overall Analysis line chart displays the total number of readings divided by SEM readings
on a day by day basis.
Figure 11 Analysis Chart
5.2. LDAP Mapping
Select Admin or Clinical from the Local Roles drop down menu.
Figure 12 Select Role to Map

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Search for LDAP Roles table on the right or scroll to the right LDAP role.
Check the applicable checkboxes to select roles from the LDAP Roles table on the right.
Figure 13 Role Mapping
Click on the Save button to save your settings.
5.3. Data Mapping
The Data Mapping allows user to correct any Patient ID that may have been entered
incorrectly or updated after the scan such as from a temporary ID to a permanent ID.
Figure 13 Device Mapping
Click on the Save button to save your Data Mapping.

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5.4. Device Status
The Device Status List displays information for all activated devices including Activation
Date, MAC Address, Serial Number, Last Communication, and Actions. All columns
can be sorted.
Figure 14 Device Status
Enter a keyword into the Search box in the upper right to display information matching the
search string. Information from all columns can be searched.
Figure 15 Device Search Results

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Click on Add Device to enter a new SEM Scanner with MAC Address and Serial number.
Figure 16 Add Device
Click on the Save button to Save the new Device.
Warning! Irreversible: Click on Actions to Remove a device from the Gateway.
Figure 17 Remove Device
5.5. Setup
The Setup screen displays the Database Info & LDAP info for the Server Address, Server
Port, Username, and Password initially set.

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Figure 18 Database & LDAP Info Screen
No edits can be made here but if you’d like to make sure the Database Info is correct, click
on the blue Test DB Connection and/or Test LDAP Connection button in the lower
left. If correct, a confirmation message will appear in the upper right.
Figure 19 Test DB & LDAP Connection Success
Note: This is a read-only screen where an Admin user can verify connection but,
user cannot change any setup data.