Related Manuals for BRUIN BIOMETRICS Provizio SEM Scanner
Summary of Contents for BRUIN BIOMETRICS Provizio SEM Scanner
- Page 1 ENGLISH US Provizio SEM Scanner ® User Manual Page 1 of 39 OTH-SEM250-0781-US Rev. 00 Proprietary & Confidential - Page 1 of 40 - Uncontrolled if Printed...
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Page 2: Table Of Contents
Charging the Device..................11 Connecting Device to Institution Wireless Networks ........13 4. Provizio SEM Scanner Operation............13 Key Features ....................13 Key Controls and Icons .................13 Turning the Provizio SEM Scanner ON ............15 Sleep Mode....................18 Select Mode of Operation................18 Select Body Location..................21 5. Taking Measurements................22 General......................22... - Page 3 Separation Distance ..................35 9. Specifications ..................36 10. Disposal....................36 10.1 Packaging......................36 10.2 Single-Use Sensor ..................37 10.3 Provizio SEM Scanner..................37 11. Troubleshooting ...................37 Page 3 of 39 OTH-SEM250-0781-US Rev. 00 Proprietary & Confidential - Page 3 of 40 - Uncontrolled if Printed...
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Page 4: Warnings And Safety Precautions
ENGLISH US This Provizio SEM Scanner User Manual is for devices of firmware 2.25 onwards. 1. Warnings and Safety Precautions Improper use or handling 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. -
Page 5: Safety Precautions
• 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, Provizio SEM Scanner should not be used in the presence of flammable anesthetic agents. -
Page 6: Correct Handling Of The Device
National Pressure Injury Advisory Panel (NPIAP) reflecting their commitment to a more accurate clinical description for pressure ulcers and injuries. Bruin Biometrics, LLC aligns with this up-to-date terminology. For the sake of clarity and completeness, we will refer to ‘pressure injuries’... -
Page 7: Indications For Use
Device Description The Provizio SEM Scanner (Figure 1) 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 ∆”). -
Page 8: Provizio Sem Scanner
Figure 2 Provizio SEM Scanner Additional Provizio SEM Scanner Components The Provizio SEM Scanner is packaged with a Charging Hub, a power supply that is used when charging the scanner and provides a base for the scanner when not in use. -
Page 9: Contraindications
Xylene 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. Page 9 of 39 OTH-SEM250-0781-US Rev. -
Page 10: 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 11: Provizio Sem Scanner Set-Up
ENGLISH US Unpacking and Inspection After the Provizio SEM Scanner is unpacked verify that the scanner has no signs of damage. If there are signs of damage, contact Customer Service. Figure 3 shows the packaged Provizio SEM Scanner. Figure 3 Packaging of Components Follow your institutional policies and procedures regarding recycling and disposal of packaging. -
Page 12: Connecting Device To Institution Wireless Networks
(Figure 5). 6. Verify that the light starts flashing green. If the green light is not flashing, then the Provizio SEM Scanner may not be positioned correctly in the cradle. Orange means an error has occurred. 7. When positioning the Charging Hub, ensure... -
Page 13: Provizio Sem Scanner Operation
The Provizio SEM Scanner has both manual patient ID entry and scanning patient ID barcodes. To be used it is separately supplied with single-use, non-sterile sensors. An overview of the key features of the Provizio SEM Scanner can be found in Figure ⚠... - Page 14 ENGLISH US Control Name Description Action button Turns the scanner ON and OFF Table 4 Mode Selection Controls Control Name Description Settings Enters the setting and configuration screens Enters barcode scanning (if available) and automatic Automatic upload upload mode Manual charting Enters manual charting mode Manual patient ID Enters manual patient ID entry...
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Page 15: Turning The Provizio Sem Scanner On
Scanner self-calibration has failed Turning the Provizio SEM Scanner ON ⚠ To prevent the spread of infection, the Provizio SEM Scanner should be properly cleaned and disinfected according to the instructions provided in this document after it is used on a patient. - Page 16 Follow the steps below to start a session with the Provizio SEM Scanner: 1. If the scanner is in the Charging Hub, remove the Provizio SEM Scanner from the Charging Hub. The unit should automatically power on. If the screen is dark, press and hold the Action button ( ) until the screen illuminates.
- Page 17 (Figure 11), remove the sensor and discard. Attempt calibration again by installing a new sensor. If the scanner continues failing calibration, please contact Customer Service. After the scanner is successfully calibrated the Provizio SEM Scanner splash screen will be displayed (Figure 12, below). Page 17 of 39 OTH-SEM250-0781-US Rev.
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Page 18: Sleep Mode
If a scanning session was underway, the scanner will return to the screen the user was last on, and resume operation from that point. Select Mode of Operation After successful calibration, the Provizio SEM Scanner offers two possible modes (Figure 13): 1. Pressing... - Page 19 ENGLISH US In each of these modes, touching the Home icon ( ) will return you to the Install Sensor Screen and a new patient session will begin. 4.5.1 Data Upload Mode Upon entering Data Upload Mode the display will show the barcode scanning screen(s) (Figure 14).
- Page 20 ENGLISH US 4.5.2 Manual Charting Mode Upon entering Manual Charting Mode, the Body Selection Screen will be displayed (Section 4.6). NOTE: In this mode, even if the scanner is configured to connect to a Gateway Server, no patient data will be saved in the scanner or uploaded. NOTE: Individual SEM Values and SEM Delta (∆) should be noted in the patient’s physical or electronic medical record per your institutions policies and procedures.
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Page 21: Select Body Location
ENGLISH US Scan each body area as desired per Section 5. Touch the Refresh Icon ( ) to clear current data and commence a new scan. Touch the Home icon ( ) will return you to the Install Sensor Screen and a new patient session will begin. -
Page 22: Taking Measurements
Figure 20 Leaving Scanning Session 5. Taking Measurements General ⚠ Do not use the Provizio SEM Scanner on broken or otherwise compromised skin. Page 22 of 39 OTH-SEM250-0781-US Rev. 00 Proprietary & Confidential - Page 22 of 40 - Uncontrolled if Printed... - Page 23 Do not attempt to clean or disinfect a contaminated single-use sensor. Remove the sensor from the pouch and place the sensor on the Provizio SEM Scanner connector (Figure 8). There is a notch in the sensor and a corresponding tab on the scanner connector to aid the alignment of the sensor.
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Page 24: Taking Measurements At The Sacrum
These are made by moving directionally around the bony prominence to identify healthier tissue and other damaged areas around the bony prominence. The recommended positions for Provizio SEM Scanner readings to complete for an assessment of the sacrum are shown below (Figure 22). -
Page 25: Taking Measurements At Either Heel
Measurements are made by moving directionally around the bony prominence to identify healthier tissue and other damaged areas around the bony prominence. The recommended positions for Provizio SEM Scanner readings to complete for an assessment of the left heel is shown below (Figure 23). -
Page 26: Out Of Range Readings
ENGLISH US #1: Back of the heel around the calcaneus. #2: Lateral side of the heel. Lateral side is the Avoid placing the Provizio SEM Scanner on the same side as the little toe (fifth toe). Avoid achilles tendon. placement of the Provizio SEM Scanner on the lateral malleolus #3: Medial side of the heel. -
Page 27: Finishing The Session
ENGLISH US Out of Range Warning: If the scanned reading is determined to be out of range, the Scanner will warn you by asking you to delete and rescan (Figure 24a). Replace Sensor Warning: If an out of range reading is detected twice in a row, the Scanner will ask you to change the sensor and rescan (Figure 24b). -
Page 28: Clean And Disinfect
Clean and, if needed, disinfect the scanner as directed in Section 7. ⚠ To prevent the spread of infection, the Provizio SEM Scanner should be properly cleaned and disinfected according to the instructions provided in this document after it is used on a patient. -
Page 29: Turning The Scanner Off
Do not reuse single-use sensors for multiple patients or multiple sessions. ⚠ To prevent the spread of infection, the Provizio SEM Scanner should be properly cleaned and disinfected according to the instructions provided in this User Manual after it is used on a patient. -
Page 30: Scanner Cleaning Instructions
1. Using a fresh wipe, verify the wipe is moist. 2. Thoroughly wipe all surfaces of the Provizio SEM Scanner for 45 seconds to remove dirt and debris from the SEM Scanner as shown in Figure 26a and Figure 26b. -
Page 31: Scanner Disinfection Instructions
Warranty and Disclaimer section. 7.3.1 Disinfection Steps using CaviWipe™ NOTE: When wiping the Provizio SEM Scanner with the wipe, you are applying the cleaning and disinfecting agent onto the scanner. Before starting the disinfection, first clean the scanner as described above. -
Page 32: Cleaning The Charging Hub
Cleaning the Charging Hub The Charging Hub is typically placed in a clean office environment or workstation with the clean and disinfected Provizio SEM Scanner and should be cleaned only as needed. Follow the cleaning and disinfection recommendations above for more extensive cleaning if the system is accidentally soiled or contaminated. -
Page 33: Guidance And Manufacturer's Declaration
8. Guidance and Manufacturer’s Declaration These data are included pursuant to IEC 60601-1 labelling requirements. The Provizio SEM Scanner is intended for use in the electromagnetic environment specified in Table 10. Users should ensure that the Provizio SEM Scanners are used in such an environment. -
Page 34: Electromagnetic Immunity
0 % UT; 0,5 cycle 0 % UT; 0,5 cycle interruptions, institution environment. If the At 0°, 45°, 90°, At 0°, 45°, 90°, voltage user of the Provizio SEM Scanner 135°, 180°, 135°, 180°, variations Charging Hub requires continued 225°, 270° 225°, 270°... -
Page 35: Separation Distance
Separation Distance The Provizio SEM Scanner is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Provizio SEM Scanner can help prevent electromagnetic interference by maintaining a minimum distance... -
Page 36: Specifications
SEM Value Range 1.0 to 4.5 SEM Value units SEM Value Repeatability +/- 0.2 SEM Value units The Provizio SEM Scanner should only be stored at Storage temperatures ranging from -4ºF (-20ºC) to 113ºF (45ºC) at 5% to 90% relative humidity (non-condensing). -
Page 37: Single-Use Sensor
Service. Table 14 Troubleshooting Problem Resolution The scanner does not turn on Ensure Provizio SEM Scanner is fully charged per Section 3.2. The scanner shuts off prior to Ensure Provizio SEM Scanner is fully charged per recording a reading Section 3.2. - Page 38 ENGLISH US Problem Resolution There is no indication of an SEM Ensure the Provizio SEM Scanner is turned on. measurement during a session by visual flash, sound or change on Ensure the scanner is on the measurement screen the screen for the selected mode.
- Page 39 ENGLISH US Pat. https://sem-scanner.com/product/bbi-intellectual-property/ ©2023 Bruin Biometrics LLC or its affiliates. All rights reserved. Emergo Europe Bruin Biometrics, LLC Westervoortsedijk 60 10877 Wilshire Blvd, Suite 1600 6827 AT Arnhem Los Angeles, CA 90024 USA THE NETHERLANDS Phone: +1 (310) 268-9494...
- Page 40 OTH-SEM250-0781-US Provizio SEM Scanner E250 User Manual Rev 00 (DOC- 1093) Ver. 0 Approved By: (CO-247) User Manual Documentation Description This change will complete the following: Publication of OTH-SEM250-0781-US and OTH-SEM250-0781-OUS. Content based on the original OTH-0359 Manuals with the following changes: OTH-SEM250-0781-OUS: UK language updates throughout Removal of US specific warning in Section 1.1 ‘Warnings’...