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ENGLISH OUS indications

Page 3 of 50

OTH-SEM-IFU-OUS-0359 Rev I

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 .................................................................................... 29

Finishing the Session ............................................................................................................................. 31

Remove the Single-Use Sensor - S only .............................................................................. 31

Clean and disinfect ................................................................................................................... 31

Data upload ............................................................................................................................... 31

Turning the Scanner OFF ....................................................................................................... 32

Cleaning and disinfection ..................................................................................................................... 33

Cleaning and disinfection overview ...................................................................................... 33

Scanner cleaning instructions ................................................................................................ 34

Scanner disinfection instructions .......................................................................................... 35

7.3.1

Disinfection steps using CaviWipe ....................................................................................... 35

Cleaning the Charging Hub .................................................................................................... 36

Clinical interpretation .......................................................................................................................... 38

Deriving SEM Scanner Delta (∆) Values

.............................................................................. 38

8.1.1

SEM200-008

–

Study Population ........................................................................................... 38

8.1.2

SEM200-008

–

Results ............................................................................................................. 39

Guidance and Manufacturer’s Declaration –

Electromagnetic Emissions ................................ 42

Electromagnetic Environment ............................................................................................... 42

Electromagnetic Immunity ...................................................................................................... 43

Separation distance .................................................................................................................. 45

Specifications .......................................................................................................................................... 46

Содержание Provizio SEM Scanner FH

Страница 1: ...ENGLISH OUS indications Page 1 of 50 OTH SEM IFU OUS 0359 Rev I Provizio SEM Scanner S Provizio SEM Scanner FH User manual...

Страница 2: ...9 2 8 Intended user profile 9 2 9 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 Devi...

Страница 3: ...31 Clean and disinfect 31 Data upload 31 Turning the Scanner OFF 32 Cleaning and disinfection 33 Cleaning and disinfection overview 33 Scanner cleaning instructions 34 Scanner disinfection instruction...

Страница 4: ...ENGLISH OUS indications Page 4 of 50 OTH SEM IFU OUS 0359 Rev I Disposal 47 Packaging 47 Single use sensor 47 Provizio SEM Scanner 47 Troubleshooting 48...

Страница 5: ...vizio 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 US and internationa...

Страница 6: ...lectric shock 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 co...

Страница 7: ...calibrated and is provided with a Charging Hub and power supply for recharging the scanner The Provizio SEM Scanner assesses changes in electrical capacitance of tissue and expresses the result in a...

Страница 8: ...ent ID barcodes and Provizio SEM Scanner S with a separately supplied single use non sterile sensor and having both manual patient ID entry and scanning patient ID barcodes The Provizio SEM Scanner FH...

Страница 9: ...ctions 2 6 OEM Parts Kit In the event of misplacing or losing the components provided with the Provizio SEM Scanner an OEM Parts Kit is available for purchase to replace these items The Kit includes a...

Страница 10: ...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...

Страница 11: ...owed 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 enclosu...

Страница 12: ...vice if there are signs of damage Figure 4 shows the packaged Provizio SEM Scanner Figure 4 Packaging of components Follow your institutional policies and procedures regarding recycling and disposal o...

Страница 13: ...gently turning to the left The pins should not disengage from the adapter Figure 5 AC DC Wall Adapter 3 Insert the cylindrical connector of the adapter into the back of the Charging Hub 4 Plug the pow...

Страница 14: ...ht may remain on for a short time when the Charging Hub has been disconnected from the mains This is normal behaviour 10 Refer to Section 6 3 for more information regarding the upload of patient data...

Страница 15: ...e use non sterile sensor and having both manual patient ID entry and scanning patient ID barcodes The Provizio SEM Scanner FH is distinguished by the orange concentric rings on the sensor connector Th...

Страница 16: ...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...

Страница 17: ...mode Manual patient ID Enters manual patient ID entry Training Enters training and research mode Table 5 Navigation controls Control Name Description Home Return to home and start a new scanning sess...

Страница 18: ...dicator Scanner docked but not charging Battery indicator Battery level low Battery indicator Intermediate battery levels Battery indicator Intermediate battery level minimum for initial device Batter...

Страница 19: ...anner 1 Do not touch the sensor area Figure 9 of the scanner during start up as the scanner is performing a self calibration and touching the sensor could invalidate the results There is no danger of...

Страница 20: ...nner in sleep mode may be brought back to action mode by pressing the action button If a scanning session was underway the scanner will return to the screen the user was last on and resume operation f...

Страница 21: ...me sensor in one session Make sure however that a new sensor is used for each new session A session is defined as scanning the sacrum left heel and the right heel for the same patient Do not attempt t...

Страница 22: ...oded wristband and the Gateway Software is installed on the institution s WIFI network Figure 15 Mode selection 2 Pressing the Manual charting button will implement the manual operation mode This mode...

Страница 23: ...entering Automatic Upload mode the Manual Patient ID Entry screen Section 4 6 4 will be displayed if the scanner does not have a barcode reader This will allow you to key in the patient ID If the scan...

Страница 24: ...ring Manual Charting mode the Body Selection screen will be displayed Section 4 7 NOTE In this mode even if the scanner is configured to connect to a Gateway Server no patient data will be saved in th...

Страница 25: ...he patient worn or chart barcode ID enter all the characters of the ID Use the delete key to erase errors To access numbers press the number key When done press the OK key Ok to proceed to the selecti...

Страница 26: ...measured SEM value for that area The SEM value for each body area may be deleted by touching the Delete icon next to the SEM value Figure 20 Body Location selection screen Touch the Home icon will ret...

Страница 27: ...n of patients Multiple anatomic locations may be scanned using the same sensor in one session Make sure however that a new sensor is used for each new session Do not attempt to clean or disinfect a co...

Страница 28: ...ircle on the right image displays the current SEM value measurement This measurement may be deleted by touching the Delete icon You will then see the number of measurements circles dots change accordi...

Страница 29: ...atient and restrictions prohibiting measurements at positions 5 and 6 3 3 should not be made higher than S1 of the sacral bone Taking measurements at either heel Make sure that any surface moisture or...

Страница 30: ...of the Provizio SEM Scanner on the lateral malleolus 3 Medial side of the heel Medial side is the same side as the big toe first toe Avoid placement of the Provizio SEM Scanner on the medial malleolu...

Страница 31: ...r is removed in a reverse manner of the installation The manoeuvre is a hinge like approach Firmly grip the scanner in one hand and gently pull the sensor away from the sensor connector Follow your in...

Страница 32: ...atically uploading this is usually because the Facility WIFI has not initiated a red X will appear in which case Try simply removing and replacing the device into the Charging Hub if the issue persist...

Страница 33: ...US EPA Registered cleaning and disinfection wipes described in the instructions below The Provizio SEM Scanner should never be exposed to the chemical agents listed in the Warranty and Disclaimer sect...

Страница 34: ...tte wipe from the dispenser and check the wipe is moist Thoroughly wipe all surfaces of the scanner for a minimum of 30 seconds to remove any remaining visible soil Continue wiping for the full 30 sec...

Страница 35: ...e When wiping the Provizio SEM Scanner with the wipe you are applying the cleaning and disinfecting agent to the scanner Before starting the disinfection clean the scanner as described above first 1 T...

Страница 36: ...cleaned scanner For the highest level of disinfection CaviWipe label instructions specify 3 minutes of continuous contact of the surface with the chemical agent during disinfection The surfaces should...

Страница 37: ...LISH OUS indications Page 37 of 50 OTH SEM IFU OUS 0359 Rev I Follow the cleaning and disinfection recommendations above for more extensive cleaning if the system gets soiled or contaminated accidenta...

Страница 38: ...canner 200 are applicable to the Provizio SEM Scanner System Clinical study SEM200 008 or 008 reference Okonkwo H et al 2020 A blinded clinical study using a subepidermal moisture biocapacitance measu...

Страница 39: ...of poor nutrition and or Medical procedure e g surgery x ray etc involving immobility and inability to change position lasting 4 hours or longer One hundred eighty two 182 subjects were listed as Int...

Страница 40: ...ual skin assessment This analysis rule was defined before study analysis was performed Forty eight 48 pressure injuries ulcers developed in 36 subjects in the Intent to Treat population 26 incidence i...

Страница 41: ...vity and specificity The bootstrap method was applied by sampling with replacement from the original dataset The sampling was done on a per subject basis such that all records for a randomly chosen su...

Страница 42: ...Environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR11 Group 1 The Provizio SEM Scanner device uses RF energy only for its internal function Therefore its RF...

Страница 43: ...l commercial or institutional environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV lines to earth 1 kV line s to line s 2 kV lines to earth Mains power quality should be that of a typical commer...

Страница 44: ...the Provizio SEM Scanner system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF IEC 61000 4 3 3 V m 80...

Страница 45: ...isted in Table 15 Table 15 Separation Distance Separation distance according to frequency of transmitter metres Rated maximum output power of transmitter W 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz...

Страница 46: ...e Repeatability 1 0 2 SEM Value units Storage The Provizio SEM Scanner should be stored only at temperatures ranging from 4 F 20 C to 113 F 45 C at 5 to 90 relative humidity non condensing Operating C...

Страница 47: ...g 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 C...

Страница 48: ...ed to a power source and all cables are connected securely Make sure the Provizio SEM Scanner is positioned securely in the Charging Hub Make sure that mains power is turned on The display is corrupte...

Страница 49: ...ill not attach to the sensor connector Make sure you have a Provizio SEM Scanner S version scanner Make sure the single use sensor is correctly aligned Patient data is not uploaded Make sure the scann...

Страница 50: ...Bruin Biometrics LLC 10877 Wilshire Blvd Suite 1600 Los Angeles CA 90024 USA Phone 1 310 268 9494 E mail info bruinbiometrics com Website http sem scanner com http bruinbiometrics com Emergo Europe B...

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