Related Manuals for BRUIN BIOMETRICS PROVIZIO SEM SCANNER
Summary of Contents for BRUIN BIOMETRICS PROVIZIO SEM SCANNER
- Page 1 ENGLISH (US) SEM S ® ROVIZIO CANNER ATEWAY YSTEM ANUAL Page 1 of 31 OTH-SEM250-0358 Rev D...
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Page 2: Table Of Contents
ENGLISH (US) Table of Contents ....................4 ARNINGS AND AFETY RECAUTIONS 1.1. Warnings ............................4 1.2. Cautions ............................5 ..............................5 ENERAL 2.1. Purpose .............................. 5 2.2. Requirements ........................... 5 2.3. Nomenclature ..........................6 2.4. Indications for Use .......................... 6 2.5. - Page 3 ENGLISH (US) 5.6. Settings............................. 21 5.7. Export Data ............................ 21 ..........................23 ANDHELD UPPORT 6.1. Electromagnetic Environment ....................23 6.2. Electromagnetic Immunity ......................24 6.3. Separation Distance ........................26 6.4. Specifications ..........................27 ..........................28 ROUBLESHOOTING Page 3 of 31 OTH-SEM250-0358 Rev D...
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Page 4: Arnings And Afety Recautions
ENGLISH (US) 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. -
Page 5: Cautions
▪ 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. -
Page 6: Nomenclature
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. -
Page 7: Exclusions
ENGLISH (US) 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. -
Page 8: Table Of Symbols
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... -
Page 9: Logging In
ENGLISH (US) 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. - Page 10 ENGLISH (US) Figure 2 User Language Selection Clicking on LOGIN will take you to the first screen for your Role. Page 10 of 31 OTH-SEM250-0358 Rev D...
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Page 11: Clinical Role
ENGLISH (US) 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. -
Page 12: Patient Chart
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. -
Page 13: Export Data
ENGLISH (US) 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: Page 13 of 31... - Page 14 ENGLISH (US) • All Patients or Selected Patients • Unencrypted or Encrypted Data (Patient ID, Patient Name) • For Unencrypted data, the following warning will be displayed: Exported patient data will be UNENCRYPTED. Proper safeguards should be in place to secure data. •...
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Page 15: Admin Role
ENGLISH (US) 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. Page 15 of 31 OTH-SEM250-0358 Rev D... -
Page 16: Ldap Mapping
ENGLISH (US) 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 Page 16 of 31 OTH-SEM250-0358 Rev D... -
Page 17: Data Mapping
ENGLISH (US) 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. -
Page 18: Device Status
ENGLISH (US) 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. -
Page 19: Setup
ENGLISH (US) 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. - Page 20 ENGLISH (US) 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.
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Page 21: Settings
ENGLISH (US) 5.6. 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 20 Settings Screen Select the Desired Language Click on the Save button to save the settings. - Page 22 ENGLISH (US) The available filters and options for Data Export are: • All Patients or Selected Patients • Unencrypted or Encrypted Data (Patient ID, Patient Name) • For Unencrypted data, the following warning will be displayed: Exported patient data will be UNENCRYPTED. Proper safeguards should be in place to secure data.
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Page 23: Handheld Support
ENGLISH (US) 6. Handheld Support 6.1. Electromagnetic Environment Table 3. Electromagnetic Environment Table 3. Electromagnetic Environment Page 23 of 31 OTH-SEM250-0358 Rev D... -
Page 24: Electromagnetic Immunity
ENGLISH (US) 6.2. Electromagnetic Immunity Table 4. Electromagnetic Immunity Page 24 of 31 OTH-SEM250-0358 Rev D... - Page 25 ENGLISH (US) = 2 . Page 25 of 31 OTH-SEM250-0358 Rev D...
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Page 26: Separation Distance
ENGLISH (US) 6.3. Separation Distance Table Table 5. Separation Distance Page 26 of 31 OTH-SEM250-0358 Rev D... -
Page 27: Specifications
ENGLISH (US) 6.4. Specifications Table 6. Specifications Repeatability is the variation of a single device in measuring the same location by the same person when multiple measurements are taken one after the other (“repeat”) at that time. Page 27 of 31 OTH-SEM250-0358 Rev D... -
Page 28: Troubleshooting
ENGLISH (US) 7. Troubleshooting Table 7. Troubleshooting Page 28 of 31 OTH-SEM250-0358 Rev D... - Page 29 ENGLISH (US) Page 29 of 31 OTH-SEM250-0358 Rev D...
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