ProvizioTM SEM Scanner FAQ

Section 1 Provizio™ SEM Scanner Clinical Questions

How are SEM readings affected by inflammatory markers being raised systemically by other health conditions, e.g. sepsis / lower limb edema?

The device exploits differences between the dielectric constants of materials that make up tissue. Dry tissue has a low dielectric constant while water has a dielectric constant that is 20x higher. When the sensor is pressed against an area on the skin, the SEM Scanner measures the electrical capacitance of the sensor, which is affected by the moisture within the underlying skin tissue to a depth of approximately 4 mm.

If inflammatory markers are raised systemically but there is PI/PU, for example as a result of sepsis, the Delta reading at a certain anatomical site susceptible to PI/PU and an adjacent tissue site where there is no injury would be small - because BBI’s data show the systemic conditions will cause rise in SEM readings at both sites, and hence the Delta will be normal. Likewise, in the case of a large-scale edema that is not localized, such as the legs in lymphedema, if there is no PI/PU the Delta would be small, as readings will be taken at two sites where fluid contents in tissue are similar and therefore baseline moisture levels will be high at the two sites and again, the difference between sites would be small.

How do barrier cream and agents such as protective skin sprays affect SEM readings?

The ProvizioTM SEM Scanner readings are sensitive to changes in local tissue fluid. Moisturizers and other agents, which contain water, may affect local SEM readings on a transient basis for up to 20 minutes after application. We recommend that the ProvizioTM SEM Scanner is used on clean and dry skin*.

*A publication is pending on this topic.

Any advice or information on scanning bariatric, morbidly obese patients (patients with a high body fat composition / high BMI)? Presume no evidence / contra-indication here due to the uniformity of body fat?

Our clinical data suggests that BMI is not a confounder for ProvizioTM SEM Scanner readings. SEM values may vary in reflecting tissue fluid in skin with a higher or lower fat density. However, because body fat is usually proportionally distributed in local scan areas around the bony prominences, the SEM delta reflects the distribution of measurements performed to assess localized tissue health consistently.

What evidence do you have to support the use of the Provizio™ SEM Scanner?

Section 2 Provizio™ SEM Scanner General Questions (Part 1)

What is the Provizio™ SEM Scanner?

The ProvizioTM SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for PI/PUs. The ProvizioTM SEM Scanner is the world’s first device to objectively alert clinicians to specific anatomical areas of a patient’s body at increased risk for developing pressure damage1. This data facilitates earlier, and anatomically specific interventions designed to reverse the damaging effects of pressure and shear and prevent PI/PUs from breaking through the skin. Patient risk assessments are performed with the ProvizioTM SEM Scanner before visible damage manifests at the skin surface.

Not all incipient damage will progress to a PI/PU especially when anatomically-specific interventions are applied before damage manifests at the skin’s surface.

What is included with the Provizio™ SEM Scanner?

The ProvizioTM SEM Scanner is packaged with the Instructions For Use, and a Charging Hub.

How does the Provizio™ SEM Scanner work?

A ProvizioTM SEM Scanner reading is obtained by placing the sensor against the patient’s skin. When the sensor is applied to the skin with sufficient pressure, a SEM reading is displayed on the screen. The sensor must be in complete contact with the skin to acquire a proper reading. The ProvizioTM SEM Scanner displays the most recent SEM Value and, after the third reading, a delta value is displayed, being the difference between the lowest and highest SEM Values from a series of readings performed for an anatomical location (e.g., heels/sacrum). The readings can be taken during routine clinical care such as when visual skin assessments are undertaken or hygiene care procedures.

What is the Provizio™ SEM Scanner reading?

The ProvizioTM SEM Scanner’s values change in proportion to the dielectric constant of the material in contact with the sensor. Skin and tissue in direct contact with the sensor changes the displayed value according to the level of skin and tissue’s sub-epidermal moisture (SEM). SEM has been studied as an indicator of localized edema characteristic of pressure tissue damage. The ProvizioTM SEM Scanner’s values are affected by changes in the dermis to approximately 4 mm. Recorded ProvizioTM SEM Scanner values range from 1.0 to 4.5 within the ProvizioTM SEM Scanner’s scale of 0.0-7.0.*

* Gefen A., et al. JWC. 2020

Which of my patients might benefit from the Provizio™ SEM Scanner?

All adult patients who are at risk for developing PI/PUs.

Who can use the Provizio™ SEM Scanner?

The ProvizioTM SEM Scanner is designed for use by clinical professionals in the clinical setting (by prescription only). The device may be used by clinical professionals such as nurses, nurse practitioners, healthcare assistants and/or clinical professionals specializing in wound care.

Section 2 Provizio™ SEM Scanner General Questions (Part 2)

How does the Provizio™ SEM Scanner add to current standard of care?

Current standard of care generally includes some combination of visual skin assessment and one or more PI/PU risk assessment tools such as the Braden, Waterlow, or Norton scales. The ProvizioTM SEM Scanner is an adjunct to standard of care assessments with an objective alert of specific anatomical areas of a patient’s body at increased risk of PI/PU.

Does the Provizio™ SEM scanner cause pain/discomfort to the patient?

No. Other than feeling the sensor press against the skin, our clinical studies and use in real world case studies have demonstrated that the device did not cause pain or discomfort to the patients.

Are there patients on whom the Provizio™ SEM Scanner should not be used?

Yes. The ProvizioTM SEM Scanner cannot be used on patients with broken skin over the anatomy in question. The device is not cleared for use on pediatric patients.

Is there training required to operate the Provizio™ SEM Scanner?

Yes. BBI provides comprehensive device training. Training should be undertaken before first use of the device. The Instructions for Use should be read and understood before first use to ensure correct operation of the device, and information on warnings and precautions.

How do you recommend the Provizio™ SEM Scanner be cleaned?

Refer to the Instructions For Use for detailed cleaning and disinfection steps.

How many hours of battery life does the device have?

When fully charged, the battery provides approximately three hours of ProvizioTM SEM Scanner accumulated operation. Place the device in the charging hub for at least six hours to completely charge the battery.

Is the single use sensor recyclable?

No the sensor is not recyclable and should be disposed of in normal medical waste. All packing however is 100% recyclable.

What is the shelf life of the single use sensor?

There is no specific shelf life.

Can the single use sensor be used more than once?

The single use sensor should only be used for an episode of scanning – this is defined as each heel and sacrum for a single patient in a single session. It should then be disposed of and a new sensor used for the next episode of scanning. The sensor is checked on attachment to the handset and BBI cannot guarantee that re-use will offer accurate delta readings.

Does the Provizio™ SEM Scanner work in the same way as the previous model SEM Scanner model 200?

Yes the mode of operation remains consistent. The accuracy has been verified internally and externally. The external verification was undertaken by the team at Tel Aviv University under the management of Prof A Gefen – the results were recently published- it confirmed that the ProvizioTM SEM Scanner showed the same precision as the previous version.2

1. Okonkwo H., et al (2020). A blinded clinical study using a subepidermal moisture biocapacitance device for early detection of pressure injuries. Wound Repair Regen, (online) 1-11. Available at: https://doi.org/10.1111/wrr.12790 (Accessed: 21 January 2020)

2. Peko, L. and Gefen, A. (2020), Sensitivity and laboratory performances of a second‐generation sub‐epidermal moisture measurement device. Int Wound J. 1-4. doi:10.1111/iwj.13339

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