SEM250 Provizio SEM Scanner GATEWAY User Manual
- June 9, 2024
- SEM Scanner
Table of Contents
SEM250 Provizio SEM Scanner GATEWAY
Warnings and Safety Precautions
The Provizio SEM Scanner 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 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.
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 SEM Scanner 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 the Provizio SEM Scanner User Manual.
- WARNING: To prevent cross-contamination of patients, use a new, unopened singleuse 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. 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: 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) or a Bruin Biometrics Authorized Service Center. Please contact your Product Specialist or Customer Service Representative 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 Hub slot before placing the scanner in the Charging Hub.
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.
- CAUTION : Ensure that the sensor connector is completely dry before attaching a single-use sensor to the device.
General
-
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. -
Requirements
The Bruin Biometrics Webserver Virtual Machine (VM). -
Nomenclature
Virtual Machine: The Bruin Biometrics Webserver VM that is installed on the institution provided server and provides a working environment for the Bruin Biometrics Web application. Pressure ulcers also are called pressure injuries, decubitus ulcers, bed sores or pressure sores. -
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. -
Contraindications
Not to be used on broken skin and intended for use on adult population only. -
Intended User Profile
The system is intended for use by healthcare professionals. -
Adverse Effects
There are no know adverse effects using the Provizio SEM Scanner. -
Warranty and Disclaimer
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.The use of the instrument in a manner different that 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 havebeen 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 authorized service center, unless authorized 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.
Note – No distributor, dealer or other party is authorized 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.
Table of Symbols
Logging In
No matter what privileges you have within the Gateway, your login starts the same way.
-
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. Enter the username and password that you use for other applications within your institution. Click on the LOGIN button. -
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.
Clinical Role
Patient List
This screen displays a list of all patients currently under care within your
institution. The patient list is limited by the user’s access rights to the
facility and ward. These rights are configured by your system administrator
based on your Job assignment and role. The patient list shows you 3 days of
data by default. However, it allows you to filter by a date range to expand or
contract your list of patients. It also allows you to see specific patient’s
data by entering a Patient name or Patient ID. You can also enter multiple
Patient names or Patient ID’s, separated by Comma.
After changing any options, you must click “Refresh data” to refresh data on
your screen.
You can access additional filter options by clicking on Filter button. This
will open a popup window with filter options to select.
The options are:
- Facility – Allows you to filter your data by a single facility
- Wards – Allows you to select multiple wards by which to filter your data
- Devices – Allows you to select multiple devices by which to filter your data – note device refers to individual Provizio SEM Scanners
- Patient ID(s) – Allows you to enter multiple patient IDs by which to filter your data
- Reading Type – Can be used independently to select Sacrum, Right Heel, or Left Heel
The filter screen will have 2 Actions:
- Close – To Discard your changes and close the Filter screen
- Apply – To Apply your filter and Close the Screen and update the Patient list
Patient list will allow you to “Click” on any row to view Patient Chart.
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 i.e. delta D>0.6. The icon legend is shown at the top of the
page. Hovering over an icon will display the numeric details of that data
point.
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.
Close the browser window to exit the session.
Export Data
The Export Data feature allows users to select criteria and Export SEM data in
CSV format for the selected options.
The Export Data screen allows you to view data based on your selections before
exporting.
There are 2 options selected by default:
Export Data For All Patients
Encrypt Data – (Recommended, Non-identifiable Patient ID & Patient Name)
A warning will display when Exporting patient data as UNENCRYPTED. Proper
safeguards should be in place to secure the data. The Export Data list allows
you to add date range to expand or contract your list of patients. It also
allows you to see specific patient’s data by entering Patient name or Patient
ID. You can also enter multiple Patient names or Patient ID’s, separated by
Comma. After changing any options, you must click “Refresh data” to refresh
data on your screen You can access additional filter options by clicking on
Filter button. This will open a popup window with filter options to select.
The options are:
- Facility – Allows you to filter your data by a single facility
- Wards – Allows you to select multiple wards by which to filter your data
- Devices – Allows you to select multiple devices by which to filter your data – note device refers to individual Provizio SEM Scanners
- Patient ID(s) – Allows you to enter multiple patient IDs by which to filter your data
- Reading Type – Can be used independently to select Sacrum, Right Heel, or Left Heel
The filter screen will have 2 Actions:
- Close – To Discard your changes and close the Filter screen
- Apply – To Apply your filter and Close the Screen and update the Patient list
“Download CSV” will only be enabled, if any data row is present in the Export Data Table. Clicking on “Download CSV” will download the file (csv or zip) on your computer hard drive in the download folder. This file can be opened in Excel. Close the browser window to exit the session.
Patient Name Edit (Configurable Feature)
The configurable feature for Editing Patient Name is only available if the
facility’s ADMIN has set up this feature on the Gateway Admin screen. It
allows user to Add or Correct Patient Names, if needed.
When user clicks on the Edit icon on a patient row, a patient name edit screen
allows the user to Add or Edit patient name, if available.
Click on Update to apply Changes. A confirmation dialog will appear.
Confirm or cancel the update to close the Dialog.
Admin Role
The Admin Menu lists several options to allow management of Dashboard, Facilities, LDAP, Data Mapping, Devices, Setup, & Settings for Language and Patient Name Options.
- The “Settings menu” exposes the ability to “Enable” the “Configurable” Feature for Patient Name Edit.
- Click on Save to Apply your changes.
Dashboard
The Pie Chart below shows the breakdown of patients who have been scanned
using the Provizio SEM Scanner and are identified as being at increased risk
(D>0.6) on a given day.
The Analysis line chart displays the total number of delta readings for the
patients in the Pie Chart analysis for the past 7-day period, categorized as
either low risk (green line, D<0.6) or increased risk (amber line, D>0.6) on a
day by day basis.
Enterprise (Facilities) Option
The Facilities screen will allow admin users to enter/edit facilities for
their institution. Select Facilities Menu to manage Facilities and Wards
- To add a NEW Facility
- Click on Add Facility to Add a new facility record. The data required is:
- Facility Name
- Facility Description
- Active/Inactive Status
Click on Save to Add the facility record and enter more, if needed by
following the steps above.
To edit an EXISTING Facility
Click on Edit Facility to update an existing facility record. The data
required is:
- Facility Name
- Facility Description
- Active/Inactive Status
- Click on Update will show confirmation of changes and close the Edit Screen.
Clicking on Wards will allow admin users to enter/edit Wards for their
institution.
To add a NEW Ward
Click on Add Ward to Add a new Ward record. The data required is:
- Ward Name
- Ward Description
- Facility Name that the Ward is assigned too
- Active/Inactive Status
Click on Save to Add the Ward Record and enter more, if needed by following
the steps above.
To edit an EXISTING Ward
Click on Edit Ward to Update an existing Ward record. The data required is:
- Ward Name
- Ward Description
- Facility Name that the Ward is assigned to
- Active/Inactive Status
- Click on Update will show confirmation of Changes and Close the Edit Screen.
LDAP Mapping
Allows the Admin user to apply Facility and Wards Access rights to the user
roles in LDAP Mapping
- Admin user will first select the institution’s LDAP role
- Admin User will then Select the Gateway role to associate Gateway role to the LDAP role
- Admin User will then select one or more Facilities (searchable) to allow access to the selected Gateway role
- Admin User will then select one or more Wards (Searchable) to allow access to the selected Gateway role
- Save Button will display a confirmation message and allow more mappings, if needed.
This setup controls how Gateway users will see patient(s) on their Patient list or Data Export list. The facilities and wards access will limit the list of patients to be ones in their allowed facilities and wards.
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.
Device Status
The Device Status List displays information for all activated devices
including Activation Date, MAC Address, Serial Number, Last Communication,
Facility, Ward, Active Status, and Actions. All columns can be sorted.
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.
To add a NEW Device
Click on Add Device to enter a new Device. The data required is:
- MAC Address – without (:)
- Serial number – this can be found on the label on the back of the device. Allows Free text
- Facility Name (Select from List) that the Device will be assigned too
- Ward Name (Select from List) that the Device will be assigned too
- Active/Inactive Status
Click on Save to Add the Device.
To edit an EXISTING Device
Click on Edit Device to edit an existing Device. The data required is:
- MAC Address – without (:)
- Serial number – this can be found on the label on the back of the device. Allows Free text
- Facility Name (Select from List) that the Device will be assigned to
- Ward Name (Select from List) that the Device will be assigned to
- Active/Inactive Status
Click on Update Button to update the Device.
Setup
The Setup screen displays the Database Info & LDAP info for the Server
Address, Server Port, Username, and Password initially set.
No edits can be made here but if you would 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.
Settings
The Settings page allows a user to set Gateway’s default Language. This will
be used site-wide for any user unless the user changes it for a login
session.
Select the Desired Language
Click on the Save button to save the settings.
Export Data
The Export Data feature allows users to select criteria and Export SEM data in
CSV format for the selected options.
The Export data screen allows you to view data based on your selections before
exporting.
There are 2 options selected by default:
Export Data For All Patients
Encrypt data – (Recommended, Non-identifiable Patient ID & Patient Name)
A warning will display when Exporting patient data as UNENCRYPTED. Proper
safeguards should be in place to secure data.
The Export data list allows you to add date range to expand or contract your
list of patients.
It also allows you to see specific patient’s data by entering a Patient name
or Patient ID.
You can also enter multiple Patient names or Patient ID’s, separated by Comma.
After changing any options, you must click “Refresh data” to refresh data on
your screen.
You can access additional filter options by clicking on Filter button. This
will open a popup window with filter options to select.
The options are:
- Facility – Allows you to filter your data by a single facility
- Wards – Allows you to select multiple wards by which to filter your data
- Devices – Allows you to select multiple devices by which to filter your data – note device refers to individual Provizio SEM Scanners
- Patient ID(s) – Allows you to enter multiple patient IDs by which to filter your data Reading Type – Can be used independently to select Sacrum, Right Heel, or Left Heel
The filter screen will have 2 Actions:
- Close – To Discard your changes and close the Filter screen
- Apply – To Apply your filter and Close the Screen and update the Patient list “Download CSV” will only be enabled, if any data row is present in the Export Data Table. Clicking on “Download CSV” will download the file (csv or zip) on your computer hard drive in the download folder. This file can be opened in Excel.
Troubleshooting
If any situation cannot be resolved, please contact your system administrator or institutional Information Technology Department. If the situation can still not be resolved, please contact your Product Specialist or your Customer Service.
| Problem | Resolution |
|---|
Logging In
I do not know the URL to connect to the Gateway.| Contact your system
administrator for the correct URL for your institutions installation.
I have the Gateway URL, but my browser does not connect.| Ensure you have the
correct URL from your system administrator.
Ensure with your system administrator that your computer and intranet is configured to connect to this URL.
My login does not work.| The Gateway uses the same login information as you use for other activities.
You may not have been assigned a Gate way role. Ask your system administrator to check that you have been assigned a
Gateway role.
Patient Listings & Data
I do not see a patient listed.| The data may not have been uploaded yet. Data
is only uploaded when the Provizio SEM Scanner is placed back into the
Charging Hub.
The Gateway uses the entered/scanned patient ID to gather patient name. Ensure that the patient ID has been entered correctly.
Each Provizio SEM Scanner must be registered with the Gateway before data can be uploaded. Ensure the Provizio
SEM Scanner is listed in the Device Listings.
| Problem | Resolution |
|---|---|
| There is a Patient ID listed, but no patient name. | The Gateway uses the |
entered/scanned patient ID to gather patient name. Ensure that the patient ID
has been entered correctly.
A scan for a patient is not listed.| The data may not have been uploaded yet.
Data is only uploaded when the Provizio SEM Scanner is placed back into the
Charging Hub.
The Gateway uses the entered/scanned patient ID to gather patient name. Ensure that the patient ID has been entered correctly.
Each Provizio SEM Scanner must be registered with the Gateway. Ensure the scanner is listed in the Device Listings.
Device Listings
A Provizio SEM Scanner is not listed.| Each Provizio SEM Scanner must be
registered with the Gateway before data can be uploaded. Ensure the scanner is
listed in the Device Listings.
Application Setup
DB Connection test failed.| Contact your system administrator to ensure the
database connection information in the Gateway is correct and current.
LDAP Connection test failed.| Contact your system administrator to ensure the
LDAP connection information in the Gateway is correct and current.
I see an ‘X’ when I place the Provizio SEM Scanner in the Charging Hub after a
patient scan.| Try 1 or 2 times as network connection could have been the
issue and if the problem persists then contact your system administrator: they
will refer to a Guide to get the decoded error message and troubleshoot this
further.
Bruin Biometrics products are protected by one or more patents. Refer to https://sem-scanner.com/patents for more information.
Bruin Biometrics, LLC.
10877 Wilshire Blvd, Suite 1600
Los Angeles, CA 90024, USA
Phone 310-268-9494
E-mail: info@bruinbiometrics.com
Website: www.sem-scanner.com
Emergo Europe B. V.
Prinsessegracht 20 2514 AP, The Hague
The Netherlands
Tel: +31 70 345 8570
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park 201
Sussex Street
Sydney, NSW 2000
Australia
©2022 Bruin Biometrics LLC or its affiliates. All rights reserved.
References
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