Related Manuals for BRUIN BIOMETRICS Provizio SEM Scanner S
Summary of Contents for BRUIN BIOMETRICS Provizio SEM Scanner S
- Page 1 ENGLISH OUS indications Provizio ® SEM Scanner S Provizio ® SEM Scanner FH User manual Page 1 of 50 OTH-SEM-IFU-OUS-0359 Rev I...
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Page 2: Table Of Contents
Adverse effects ..........................9 2.10 Warranty ............................ 10 2.11 Table of symbols ........................11 Provizio SEM Scanner FH and Provizio SEM Scanner S Set-up ..........12 Unpacking and inspection ....................... 12 Charging the Device ........................ 12 Connecting the Provizio SEM Scanner to Institution Wireless Networks ....14 Provizio SEM Scanner FH and Provizio SEM Scanner S Operation ........... - Page 3 ENGLISH OUS indications 4.6.1 Automatic Upload mode ......................23 4.6.2 Manual Charting mode ......................24 4.6.3 Training mode ........................... 24 4.6.4 Manual Patient ID Entry ......................25 Select Body Location ....................... 25 Taking measurements .......................... 27 General ............................27 Taking measurements at the sacrum ................... 28 Taking measurements at either heel ..................
- Page 4 ENGLISH OUS indications Disposal ..............................47 Packaging ............................ 47 Single-use sensor ........................47 Provizio SEM Scanner ......................47 Troubleshooting ............................ 48 Page 4 of 50 OTH-SEM-IFU-OUS-0359 Rev I...
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Page 5: Warnings And Safety Precautions
ENGLISH OUS indications Warnings and safety precautions ® ® The Provizio SEM Scanner FH and Provizio SEM Scanner S have been designed and constructed in accordance with applicable United States (US) regulations and requirements, as well as US and international standards for operation of electrical equipment, electromagnetic compatibility and stipulated safety requirements. -
Page 6: Cautions
▪ WARNING: The Provizio SEM Scanners should not be used in the presence of flammable anaesthetic agents to avoid the risk of explosion. ▪ WARNING: The Provizio SEM Scanner S will not operate correctly without first installing a single-use sensor connector. -
Page 7: General
See Section 8 for details of interpretation of the SEM values. Figure 1 Provizio SEM Scanner S showing scanner and charging hub The scanner can transmit collected SEM Values and SEM, when associated with a valid patient identification number to a centralised, in-institution, data server for later review. -
Page 8: Provizio Sem Scanner
The Provizio SEM Scanner FH is distinguished by the orange concentric rings on the sensor connector. The Provizio SEM Scanner S is distinguished by the blue sensor with three gold connectors. The Provizio SEM Scanner S will not operate correctly without first installing a single- use sensor connector. -
Page 9: Additional Provizio Sem Scanner Components
ENGLISH OUS indications Figure 3 Provizio SEM Scanner S Additional Provizio SEM Scanner components The Provizio SEM Scanner is packaged with a Charging Hub, power supply that is used when charging the scanner and provides a base for the scanner when not in use. The internal battery is recharged by wireless power transfer when the scanner is placed in the Charging Hub. -
Page 10: Warranty
Bruin Biometrics LLC or its authorised service centre, unless authorised 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. -
Page 11: Table Of Symbols
ENGLISH OUS indications 2.11 Table of symbols Table 2. Table of symbols Symbol Meaning Manufacturer’s Catalogue designation or number Serial number Lot number CE mark in accordance to the European Medical Device Directive European Union Authorised 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... -
Page 12: Provizio Sem Scanner Fh And Provizio Sem Scanner S Set-Up
ENGLISH OUS indications Provizio SEM Scanner FH and Provizio SEM Scanner S Set-up Unpacking and inspection After the Provizio SEM Scanner is unpacked verify that the scanner has no signs of damage. Contact Customer Service if there are signs of damage. Figure 4 shows the packaged Provizio SEM Scanner. - Page 13 ENGLISH OUS indications Charge the Provizio SEM Scanner before using it for the first time to at least four bars (five bars is the maximum). Follow the steps below to charge the scanner: 1. The Charging Hub is packaged with an AC to DC wall adapter (Figure 5).
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Page 14: Connecting The Provizio Sem Scanner To Institution Wireless Networks
ENGLISH OUS indications 8. The touchscreen is disabled while the scanner is in the Charging Hub. The display shows the status of the data upload and the battery charge level. (Figure 7). 9. NOTE: The indicator light may remain on for a short time when the Charging Hub has been disconnected from the mains, This is normal behaviour. -
Page 15: Provizio Sem Scanner Fh And Provizio Sem Scanner S Operation
The Provizio SEM Scanner FH is distinguished by the orange concentric rings on the sensor connector. The Provizio SEM Scanner S is distinguished by the blue sensor with three gold connectors. The Provizio SEM Scanner S will not operate correctly without first installing a single- use sensor. -
Page 16: Key Features
ENGLISH OUS indications Key Features Figure 8 Key features of the Provizio SEM Scanner S (left) and Provizio SEM Scanner FH (middle) Key controls and icons The following tables describe the controls and icons used throughout this manual and the Provizio SEM Scanner System. - Page 17 ENGLISH OUS indications 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 Training Enters training and research mode Table 5 Navigation controls...
- Page 18 ENGLISH OUS indications Table 6 Other controls Control Name Description Sound Enter sound setting screen Clears the current set of scans and delta in training Refresh mode Table 7 Battery level icons Control Name Description Battery indicator Scanner docked but not charging Battery indicator Battery level low Battery indicator...
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Page 19: Turning The Provizio Sem Scanner On
ENGLISH OUS indications Turning the Provizio SEM Scanner ON The Provizio SEM Scanner should be cleaned and disinfected properly according to the instructions provided in this document after it is used on a patient to prevent the spread of infection. Use a new, unopened single-use sensor per patient, per session to prevent cross- contamination of patients. -
Page 20: Sleep Mode
Install the Single-Use Sensor - S only This section is applicable only to the Provizio SEM Scanner S. Use a new, unopened single-use sensor per patient, per session to prevent cross- contamination of patients. Multiple anatomic locations may be scanned using the same sensor in one session. -
Page 21: Installing The Sensor
ENGLISH OUS indications Figure 11 Install Sensor Figure 12 Sensor calibrating Figure 13 Failed screen calibration After you have installed the sensor (Section 4.5), press the Next Screen ( ). The scanner will then re-calibrate to the installed sensor (Figure 12). If the scanner fails calibration (Figure 13), remove the sensor and discard. -
Page 22: Select Mode Of Operation
ENGLISH OUS indications Figure 14 Installation of the Single-Use Sensor Once the sensor has been installed, press the Next Screen ( ) to advance to next step, as described above. Select mode of operation After successful calibration, the Provizio SEM Scanner offers three possible workflows (Figure 15): 1. -
Page 23: Automatic Upload Mode
In each of these modes, touching the Home icon ( ) will return you to the Install Sensor Screen (Provizio SEM Scanner S only, Section 4.5) or the Mode Selection Screen (Provizio SEM Scanner only), and a new patient session will begin. -
Page 24: Manual Charting Mode
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 (Provizio SEM Scanner S only, Section 4.5) or the Mode Selection Screen (Provizio SEM Scanner only), and a new patient session will begin. -
Page 25: Manual Patient Id Entry
ENGLISH OUS indications 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 and SEM∆ should be noted in the patient’s physical or electronic medical record per your institutions policies and procedures. - Page 26 Figure 20 Body Location selection screen Touch the Home icon ( ) will return you to the Install Sensor Screen (Provizio SEM Scanner S only, Section 4.5) or the Mode Selection Screen (Provizio SEM Scanner only), and a new patient session will begin.
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Page 27: Taking Measurements
ENGLISH OUS indications Taking measurements General DO NOT use the Provizio SEM Scanner on broken or otherwise compromised skin. The Provizio SEM Scanner should be cleaned and disinfected properly according to the instructions provided in this document after it is used on a patient to prevent the spread of infection. -
Page 28: Taking Measurements At The Sacrum
ENGLISH OUS indications In Barcode and Manual Charting modes, the body area selected will appear next down. In Training mode, this is blank. Next, below are indicators of the number of scans taken. Circles indicate a scan not yet performed, whereas the dot indicates that a scan has occurred. For the sacrum body area, six circles are initially shown. -
Page 29: Taking Measurements At Either Heel
ENGLISH OUS indications For the sacrum a minimum of six (6) SEM value measurements are recommended. These are taken 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 30 ENGLISH OUS indications #1: Back of the heel around the calcaneus. Avoid #2: Lateral side of the heel. Lateral side is the same placing the Provizio SEM Scanner on the Achilles side as the little toe (fifth toe). Avoid placement of the tendon.
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Page 31: Finishing The Session
Finishing the Session Remove the Single-Use Sensor - S only This section is applicable only to the Provizio SEM Scanner S. Use a new, unopened single-use sensor per patient, per session to prevent cross- contamination of patients. Multiple anatomic locations may be scanned using the same sensor in one session. -
Page 32: Turning The Scanner Off
ENGLISH OUS indications Upon placement into the Charging Hub, the scanner switches into charging mode and initiates wireless communications with the configured wireless network and then connects to the Gateway Server. All communications are encrypted and secure. Once the scanner has connected to the Gateway Server, all stored data sessions are uploaded to the Gateway Server and then deleted from the Provizio SEM Scanner. -
Page 33: Cleaning And Disinfection
The entire body of the scanner is capable of being cleaned and disinfected safely, including the Sensor Connector (Provizio SEM Scanner S only) and the Sensor (Provizio SEM Scanner FH only). Single-use sensors should be disposed of following institutional policies and procedures for patient-contacting materials. -
Page 34: Scanner Cleaning Instructions
ENGLISH OUS indications Scanner cleaning instructions The Provizio SEM Scanner should be cleaned using nonabrasive cleaning wipes and wetted with agents such as isopropyl alcohol or mild detergents. Use a fresh wipe and make sure it is moist. 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 26 and Figure 27. -
Page 35: Scanner Disinfection Instructions
ENGLISH OUS indications Scanner disinfection instructions To disinfect the external surfaces of the Provizio SEM Scanner properly using CaviWipe™ by Metrex Research, follow the steps below. It is recommended to wear gloves and an apron during cleaning and disinfection of the device. Please read the CaviWipe™ label instructions for a full list of precautions and use guidelines: manufacturers are periodically updated. -
Page 36: Cleaning The Charging Hub
ENGLISH OUS indications Take a fresh towelette wipe from the dispenser and check that it is moist. Thoroughly wipe all surfaces of the scanner for a minimum of 30 seconds. Continue wiping for the full 30 seconds even if there is no visible dirt and debris. The device surface should be fully coated with the wipe solution. - Page 37 ENGLISH OUS indications Follow the cleaning and disinfection recommendations above for more extensive cleaning if the system gets soiled or contaminated accidentally. Page 37 of 50 OTH-SEM-IFU-OUS-0359 Rev I...
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Page 38: Clinical Interpretation
ENGLISH OUS indications Clinical interpretation Clinical interpretation of the Provizio SEM Scanner scans begins by collecting a set of measurements described in Section 5 performed on each anatomical site under assessment. After the set of measurements have been collected, the SEM value will be displayed. A SEM... -
Page 39: Sem200-008 - Results
ENGLISH OUS indications subjects were at varying risk for developing pressure injuries/ulcers (as defined by current risk assessment tools) and thus interventions were made. According to the study protocol’s inclusion criteria, these patients were defined as being “at risk” if they met one of the following criteria: •... - Page 40 ENGLISH OUS indications Table 10 Final results for individual anatomical locations Total Patients in ITT No Visible Pressure Population (182) / Total Visible Pressure Ulcer Ulcer Anatomical Locations (437) SEMΔ ≥ 0.6 SEMΔ < 0.6 Table 11 Range of SEM ∆ and confidence intervals using bootstrap method Sensitivity Specificity SEM∆...
- Page 41 ENGLISH OUS indications • False positives - no visible pressure injury/ulcer and a SEM delta of 0.6 or above (“abnormal levels of SEM”). There were 261 anatomical sites in this category. The bootstrap method was used to account appropriately for the within subject correlation in the estimates of the 95% confidence intervals for sensitivity and specificity.
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Page 42: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
ENGLISH OUS indications Guidance and Manufacturer’s Declaration – Electromagnetic Emissions This data is included pursuant to IEC 60601-1 labelling requirements. The Provizio SEM Scanner is intended for use in the electromagnetic environment specified in Table 12. Users should make sure that the Provizio SEM Scanners are used in such an environment. -
Page 43: Electromagnetic Immunity
ENGLISH OUS indications Electromagnetic Immunity Table 13 Electromagnetic Immunity – Part 1 Immunity IEC 60601 Compliance Electromagnetic Environment - Test Guidance Test Level Electrostatic ± 8 kV contact ± 8 kV contact Floors should be wood, concrete or discharge (ESD) ceramic tile. - Page 44 ENGLISH OUS indications Table 14 Electromagnetic Immunity – Part 2 Immunity IEC 60601 Compliance Electromagnetic Environment - Test Guidance Test Level Power 30 A/m 30 A/m Power frequency magnetic fields should be frequency a level characteristic of a typical location in (50/60 Hz) a typical commercial or institution magnetic field...
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Page 45: Separation Distance
ENGLISH OUS indications 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 between portable and mobile RF communications equipment (transmitters) and the Provizio SEM Scanner as recommended below, according to the maximum output power of the communications equipment. -
Page 46: Specifications
ENGLISH OUS indications Specifications Table 16 Specifications Item Specifications Applied Part Type BF Battery Life 3 hours (typical) Method of Cleaning and Clean the device as defined in Section 7 Disinfection Water ingress protection IPX1 Duty Cycle Continuous operation Power Source Internally powered equipment SEM Value Range 1.0 to 4.5 SEM Value units... - Page 47 ENGLISH OUS indications Disposal Packaging Follow your institutional policies and procedures regarding recycling and disposal of packaging. Single-use sensor Single-use sensors should be disposed of following institutional policies and procedures for patient-contacting materials. Provizio SEM Scanner Cleaned and disinfected Provizio SEM Scanner should be disposed of according to local regulations for electrical and electronic waste disposal.
- Page 48 Make sure the scanner is on the measurement change on the screen. screen for the selected mode. Make sure a single-use sensor is positioned correctly (Provizio SEM Scanner S only). Page 48 of 50 OTH-SEM-IFU-OUS-0359 Rev I...
- Page 49 ENGLISH OUS indications Problem Resolution The single-use sensor will not attach to the Make sure you have a Provizio SEM Scanner S sensor connector. version scanner. Make sure the single-use sensor is correctly aligned. Patient data is not uploaded. Make sure the scanner is correctly configured to connect to the Gateway Server.
- Page 50 ENGLISH OUS indications Pat. https://sem-scanner.com/product/bbi-intellectual-property/ ©2022 Bruin Biometrics LLC or its affiliates. All rights reserved. Bruin Biometrics, LLC Emergo Europe B. V. 10877 Wilshire Blvd, Suite 1600 Prinsessegracht 20 Los Angeles, CA 90024 USA 2514 AP, The Hague Phone: +1 (310) 268-9494...
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