BBI Provizio SEM Scanner S Manual de usuario

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Provizio®SEM Scanner S

Provizio®SEM Scanner FH

User Manual

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Table of Contents 
 Warnings and Safety Precautions.........................................................................................................5 
 Warnings.......................................................................................................................................5 
 Cautions ........................................................................................................................................6 
 General.......................................................................................................................................................7 
2.1 Nomenclature..............................................................................................................................7 
2.2 Indications for Use......................................................................................................................7 
2.3 Device Description.....................................................................................................................7 
2.4 Provizio SEM Scanner.................................................................................................................8 
2.5 Additional Provizio SEM Scanner Components ...................................................................8 
2.6 Contraindications........................................................................................................................9 
2.7 Intended User Profile .................................................................................................................9 
2.8 Adverse Effects ............................................................................................................................9 
2.9 Warranty and Disclaimer..........................................................................................................9 
2.1.1 Exclusions......................................................................................................................................9 
2.1.2 Disclaimer of Additional Warranties................................................................................... 10 
2.10 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........................................... 15 
 Key Features ............................................................................................................................. 16 
 Key Controls and Icons.......................................................................................................... 16 
 Turning the Provizio SEM Scanner ON .............................................................................. 19 
 Sleep Mode ................................................................................................................................ 20 
 Install the Single-Use Sensor - S only .................................................................................. 20 
4.5.1 Installing the Sensor................................................................................................................. 21 

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 Select Mode of Operation ..................................................................................................... 22 
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 
 Making Measurements ......................................................................................................................... 27 
 General....................................................................................................................................... 27 
 Making Measurements at the Sacrum.................................................................................. 28 
 Making Measurements at Either Heel.................................................................................. 29 
 Recommended Readings at Other Body Locations ......................................................... 31 
 Finishing the Session............................................................................................................................. 32 
 Remove the Single-Use Sensor - S only.............................................................................. 32 
 Clean and Disinfect.................................................................................................................. 32 
 Data Upload .............................................................................................................................. 32 
 Turning the Scanner OFF....................................................................................................... 33 
 Cleaning and Disinfection ................................................................................................................... 34 
 Cleaning and Disinfection Overview ................................................................................... 34 
 Scanner Cleaning Instructions............................................................................................... 35 
 Scanner Disinfection Instructions......................................................................................... 36 
7.3.1 Disinfection Steps using CaviWipe ...................................................................................... 36 
 Cleaning the Charging Hub.................................................................................................... 37 
 Clinical Interpretation.......................................................................................................................... 39 
 Deriving SEM Scanner Delta (∆) Values.............................................................................. 39 
8.1.1 SEM200-008 –Study Population........................................................................................... 39 
8.1.2 SEM200-008 –Results............................................................................................................. 40 
 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ................................ 42 
 Electromagnetic Environment ............................................................................................... 42 
 Electromagnetic Immunity...................................................................................................... 43 

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Separation Distance................................................................................................................. 45

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

Disposal................................................................................................................................................... 47

Packaging .................................................................................................................................... 47

Single Use Sensor..................................................................................................................... 47

Provizio SEM Scanner.............................................................................................................. 47

Troubleshooting.................................................................................................................................... 48

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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 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.

Warnings

▪WARNING: The standard of care should be followed for reducing the risk of developing

pressure injuries/ulcers. Readings from the Provizio SEM Scanners can be used to support

increased intervention; but should never be the basis for decreasing intervention.

▪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 this document

after it is used on a patient.

▪WARNING: To prevent cross-contamination of patients, use a new, unopened single-

use sensor per patient, per session. Multiple anatomic locations may be scanned using

the same sensor in one session, however, ensure a new sensor is used for each new

session.

▪WARNING: Do not attempt to clean or disinfect a contaminated single-use sensor.

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▪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.

▪WARNING: Do not attempt to disassemble or otherwise modify the Provizio SEM

Scanners as this can result in unintended hazards. The Provizio SEM Scanner System can

only be serviced by the manufacturer (Bruin Biometrics, BBI) or a BBI Authorized Service

Center. Please contact your BBI Product Specialist or Customer Service 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 Scanners 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 there is no foreign material in the Charging Hub slot before placing

the scanner in the Charging Hub.

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 Provizio SEM

Scanner is fully charged prior to use.

▪CAUTION: Do not immerse the Provizio SEM Scanner. Immersion may damage the

scanner and prevent it functioning normally.

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General

2.1 Nomenclature

Pressure ulcers also are called pressure injuries, decubitus ulcers, bed sores or pressure sores.

2.2 Indications for Use

The Provizio SEM Scanners are intended as an adjunct to current standard of care for the

detection of deep and early-stage pressure-induced injuries/ulcers by health care professionals.

2.3 Device Description

The Provizio SEM Scanner 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∆”). The

Provizio SEM Scanner is pre-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 SEM Value of 1.0 to 4.5. SEM Value is unitless (not an International System of Units

measurement). The Provizio SEM Scanner S displays a SEMvalue after a minimum of three (3)

SEM Values have been measured. The reported SEMΔis used as an adjunct to the standard of

care when assessing the heels and sacrum of patients who are at increased risk for pressure

injuries/ulcers. 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 centralized, in-institution, data server for later review. Refer to the

Gateway Software User’s Manual for more information.

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2.4 Provizio SEM Scanner

The Provizio SEM Scanner System is provided in three versions:

•Provizio SEM Scanner S with a separately supplied single-use, non-sterile sensor and

having manual patient ID entry only;

•Provizio SEM Scanner FH with the sensor head integrated into the scanner and having

both manual patient ID entry and scanning patient 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 is distinguished by the orange concentric rings on the sensor

head.

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 head

Figure 2 Provizio SEM Scanner FH

Figure 3 Provizio SEM Scanner S

2.5 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. See

Section 3.2 for charging instructions.

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2.6 Contraindications

Do not use on broken skin.

2.7 Intended User Profile

The system is intended for use by healthcare professionals.

2.8 Adverse Effects

There are no known adverse effects using the Provizio SEM Scanner.

2.9 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. Bruin Biometrics LLC (BBI)

warrants the Provizio SEM Scanner against defects in materials and workmanship for three (3)

years from the date of purchase from BBI or its subsidiaries. This warranty is given only to the

original purchaser of the Provizio SEM Scanner. BBI’s obligation under the warranty is to provide

for repair, or at its option, to provide a replacement product. No other remedy is obligated by

this warranty. All special, incidental, and coincidental damages are excluded.

There are no conditions associated with varnishing, enameling, oxidation and similar protective

finishes, as well as covering with sealing compounds that can re-plasticize at temperatures to be

expected during normal operation.

To request repair or replacement under this warranty, purchasers should contact their local

Customer Service provider.

Warranty conditions may differ in some countries. Contact your Customer Service provider for

warranty terms.

Risk of loss or damage during shipments under this warranty shall be borne by the party shipping

the Product. Products shipped by the Purchaser under this warranty shall be suitably packaged

to protect the Product. If Purchaser ships a product to BBI in unsuitable packaging, any physical

damage present in the Product on receipt and inspection by BBI, and not previously reported,

will be presumed to have occurred in transit and will be the responsibility of the Purchaser.

2.1.1 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 Provizio SEM Scanner.

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This 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 BBI Instructions for Use, (d) on

which the serial number has been removed or made illegible, (e) that have been modified by

anyone other than BBI or its authorized service center, unless authorized prior to such service

by BBI, (f) that are equipment sold as used, or (g) that are exposed to agents listed in Table 12,

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

2.1.2 Disclaimer of Additional Warranties

No distributor, dealer or other party is authorized to make any warranty on behalf of BBI, or to

assume for BBI any other liability with respect to the Provizio SEM Scanner.

The contents of these Instructions for Use do not constitute a warranty.

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