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Provizio® SEM Scanner is an identification tool for pressure ulcers
User Manual for SEM Scanner models including: SEM250 Provizio SEM Scanner GATEWAY, SEM250, Provizio SEM Scanner GATEWAY, SEM Scanner GATEWAY, Scanner GATEWAY
User Guides - User Manuals | Provizio™ SEM Scanner
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DocumentDocumentENGLISH (US) PROVIZIO® SEM SCANNER GATEWAY USER MANUAL OTH-SEM250-0358 Rev H 1 ENGLISH (US) 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 .................................................................................................................................. 5 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 2.9 TABLE OF SYMBOLS ............................................................................................................................. 7 3. LOGGING IN ....................................................................................................................................... 8 3.1 ENTER CREDENTIALS .............................................................................................................................. 8 3.2 SELECT A LANGUAGE............................................................................................................................... 8 4. CLINICAL ROLE ................................................................................................................................. 9 4.1 PATIENT LIST ........................................................................................................................................ 9 4.2 PATIENT CHART................................................................................................................................. 10 4.3 EXPORT DATA .................................................................................................................................... 11 4.4 PATIENT NAME EDIT (OPTIONAL FEATURE) ..................................................................................... 12 5. ADMIN ROLE ................................................................................................................................... 14 5.1 DASHBOARD......................................................................................................................................... 15 5.2 ENTERPRISE (FACILITIES) OPTION...................................................................................................... 15 5.3 LDAP MAPPING.................................................................................................................................. 18 5.4 DATA MAPPING ................................................................................................................................ 18 5.5 DEVICE STATUS .................................................................................................................................. 18 5.6 SETUP ............................................................................................................................................... 21 5.7 SETTINGS ......................................................................................................................................... 22 5.8 EXPORT DATA ................................................................................................................................... 22 OTH-SEM250-0358 Rev H 2 ENGLISH (US) 6 TROUBLESHOOTING ...................................................................................................................... 24 OTH-SEM250-0358 Rev H 3 ENGLISH (US) 1. 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. 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 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 usingthe 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. OTH-SEM250-0358 Rev H 4 ENGLISH (US) 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. 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. CAUTION: Ensure that the sensor connector is completely dry before attaching a single-use sensor to the device. 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 The Bruin Biometrics Webserver Virtual Machine (VM). 2.3 Nomenclature Virtual Machine: The Bruin Biometrics Webserver VM that is installed on the institutionprovided 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. OTH-SEM250-0358 Rev H 5 ENGLISH (US) 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 Not to be used on broken skin and intended for use on adult population only. 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 Provizio SEM Scanner. 2.8 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 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 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. Severe Effect NOT Recommended Benzene Cyclohexane Kerosene Nitric Acid 70% Carbon tetrachloride Ethyl Chloride Trichloroethylene Perchloroethylene Chlorobenzene Freon Lacquer Toluene Chloroform Gasoline, unleaded Naphtha Xylene Table 1 Agents That Should Never Be Used On 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. OTH-SEM250-0358 Rev H 6 ENGLISH (US) 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 with 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 Medical Device OTH-SEM250-0358 Rev H 7 ENGLISH (US) Note- features may vary according to the version of the Gateway dashboard installed. 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. 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. Figure 1 User Language Selection Clicking on LOGIN will take you to the first screen for your Role. OTH-SEM250-0358 Rev H 8 ENGLISH (US) 4. Clinical Role 4.1 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 adate 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. Figure 2 Patient List Filter Screen 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. OTH-SEM250-0358 Rev H 9 ENGLISH (US) 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 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. Figure 3 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. Figure 4 SEM Values for a Data Point Close the browser window to exit the session. OTH-SEM250-0358 Rev H 10 ENGLISH (US) 4.3 Export Data The Export Data feature allows users to select criteria and Export SEM data in CSV format for the selected options. Figure 5 Export SEM Data View 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. Figure 6 Filter Export Data OTH-SEM250-0358 Rev H 11 ENGLISH (US) 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 notedevice 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. 4.4 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. Figure 7 Patient Name Edit (Configurable Feature) 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. OTH-SEM250-0358 Rev H 12 ENGLISH (US) Figure 7a Patient Name Edit Screen (Configurable Feature) Click on Update to apply Changes. A confirmation dialog will appear. Figure 7b Patient Name Edit Confirmation (Configurable Feature) Confirm or cancel the update to close the Dialog. OTH-SEM250-0358 Rev H 13 ENGLISH (US) 5. 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. Figure 8 Admin Menu The "Settings menu" exposes the ability to "Enable" the "Configurable" Feature for Patient Name Edit. Click on Save to Apply your changes. Figure 8a Patient Name OTH-SEM250-0358 Rev H 14 ENGLISH (US) 5.1 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. Figure 9 Dashboard Chart 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. Figure 9a Analysis Chart Note the data in figure 9 & 9a is example data the graphs are a graphical portrayal and do not represent real patient data 5.2 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 OTH-SEM250-0358 Rev H 15 ENGLISH (US) Figure 10 Add Facility Screen 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. Figure 11 Edit Facility Screen Clicking on Wards will allow admin users to enter/edit Wards for their institution. Figure 12 Wards Screen To add a NEW Ward Click on Add Ward to Add a new Ward record. The data required is: OTH-SEM250-0358 Rev H 16 Ward Name Ward Description Facility Name that the Ward is assigned too Active/Inactive Status ENGLISH (US) Figure 13 Add Ward Screen 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. Figure 14 Edit Ward Screen OTH-SEM250-0358 Rev H 17 ENGLISH (US) 5.3 LDAP Mapping Allows the Admin user to apply Facility and Wards Access rights to the user roles in LDAP Mapping Figure 15 LDAP Mapping Screen 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 beones in their allowed facilities and wards. 5.4 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 16 Data Mapping Click on the Save button to save your Data Mapping. 5.5 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. OTH-SEM250-0358 Rev H 18 ENGLISH (US) Figure 17 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 18 Device Search Results 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 OTH-SEM250-0358 Rev H 19 ENGLISH (US) Figure 19 Add Device 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 Figure 20 Update Device Click on Update Button to update the Device. OTH-SEM250-0358 Rev H 20 ENGLISH (US) 5.6 Setup The Setup screen displays the Database Info & LDAP info for the Server Address, Server Port, Username, and Password initially set. Figure 21 Database & LDAP Info Screen 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. Figure 22 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. OTH-SEM250-0358 Rev H 21 ENGLISH (US) 5.7 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. Figure 23 Settings Screen Select the Desired Language Click on the Save button to save the settings. 5.8 Export Data The Export Data feature allows users to select criteria and Export SEM data in CSV format for the selected options. Figure 24 Export SEM Data View 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. OTH-SEM250-0358 Rev H 22 ENGLISH (US) 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. Figure 25 Export Filter Screen 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 to exit the session. 23 OTH-SEM250-0358 Rev H ENGLISH (US) 6 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. Table 3 Troubleshooting 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. My login does not work. Patient Listings & Data 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. 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. 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. OTH-SEM250-0358 Rev H 24 ENGLISH (US) Problem There is a Patient ID listed, but no patient name. A scan for a patient is not listed. Device Listings A Provizio SEM Scanner is not listed. Application Setup DB Connection test failed. LDAP Connection test failed. I see an `X' when I place the Provizio SEM Scanner in the Charging Hub after a patient scan. Resolution The Gateway uses the entered/scanned patient ID to gather patient name. Ensure that the patient ID has been entered correctly. 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. Each Provizio SEM Scanner must be registered with the Gateway before data can be uploaded. Ensure the scanner is listed in the Device Listings. Contact your system administrator to ensure the database connection information in the Gateway is correct and current. Contact your system administrator to ensure the LDAP connection information in the Gateway is correct and current. 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. OTH-SEM250-0358 Rev H 25 ENGLISH (US) 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 1639 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. OTH-SEM250-0358 Rev H 26