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 no pressure injury/ulcer (PI/PU), for example as a result of sepsis, the Delta reading at a certain anatomical site susceptible to pressure ulcer 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.
Dr Bates-Jensen et al also investigated this aspect– the results of which were published in WRR 2017; May; 25(3); 502-511
The Provizio 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. It is important to apply product according to manufacturer’s instructions and we recommend that the Provizio SEM Scanner is used on clean and dry skin.*
*Evans P., et al. Wounds UK. Vol 16(2); 29-35
Our clinical data suggests that BMI is not a confounder for Provizio 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.
1. Scanning should be undertaken with other care procedures such as structured hygiene 2. During which time the skin under the dressing would be assessed as per care Guidelines 3. Therefore there is no additional dressing removal required to facilitate scanning 4. Advanced dressings have specialised adhesives which ensure the vulnerable skin is not damaged on removal 5. As the scanning is undertaken at the same time there is a very limited impact on nurse time and patient disturbance
Please refer to the Bibliography in the Evidence zone
The Provizio 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 pressure ulcers.
The Provizio 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 damage. This data facilitates earlier, and anatomically specific interventions designed to reverse the damaging effects of pressure and shear and prevent PI/PU from breaking through the skin. Patient risk assessments are performed with the Provizio SEM Scanner before visible damage manifests at the skin surface.*
* 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)
The Provizio SEM Scanner is packaged with the Instructions For Use, and a Charging Hub.
A Provizio 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 Provizio 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.
The Provizio 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 Provizio SEM Scanner’s values are affected by changes in the dermis to approximately 4 mm. Recorded Provizio SEM Scanner values range from 1.0 to 4.5 within the Provizio SEM Scanner’s scale of 0.0-7.0.*
* Gefen A., et al. JWC. 2020
All adult patients who are at risk for developing PI/PUs.
The Provizio 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.
Visual skin assessment is frequently reported in published literature to be challenging in dark skin tone patients as identification of skin redness (typical visual diagnosis of category 1 PU) is difficult. In the Prevention and Treatment of Pressure Ulcers/Injuries Clinical Practice Guideline (CPG) ( EPUAP/NPIAP/PPPIA 2019) recommendation 2.7 states “When assessing darkly pigmented skin, consider assessment of skin temperature and sub-epidermal moisture as important adjunct assessment strategies”. The CPG reference B Bates Jenson WOCN 2009; 36(3);277-284 in their strength of evidence. A descriptive cohort study including pooled data from 2 pervious Nursing Home studies, n=66. Goal was to compare SEM values in persons with dark skin tone versus lighter skin tone. The author concluded: • Higher SEM Values was associated with both concurrent and incident (1 week later) skin damage in persons with dark skin tones • When more skin damage was observed, SEM values were higher at all anatomic locations.
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 Provizio 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.
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.
Yes. The Provizio 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.
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.
Refer to the Instructions For Use for detailed cleaning and disinfection steps.
When fully charged, the battery provides approximately three hours of Provizio SEM Scanner accumulated operation. Place the device in the charging hub for at least six hours to completely charge the battery.
No the sensor is not recyclable and should be disposed of in normal medical waste. All packing however is 100% recyclable.
There is no specific shelf life.
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.
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 Provizio SEM Scanner showed the same precision as the previous version.*
* 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
The Provizio SEM Scanner FH has the sensor head integrated into the scanner, distinguished by the orange concentric rings on the sensor head. Whilst the Provizio SEM Scanner S has a separately supplied single-use, non-sterile sensor for single patient use, distinguished by the blue sensor with three gold connectors
Both have manual patient ID entry and patient ID barcode scanning.
The barcode scanner will accept both 1-D and 2-D barcodes. To use the barcode scanner, please refer to the instructions listed on the Quick Start Guide within the User Guides.
Yes, the data is secure - the patient identifier/barcode together with the patient SEM readings are sent to the Gateway in encrypted form, once uploaded to the Gateway the encrypted data is then deleted from the Provizio SEM Scanner.
The Gateway Dashboard allows the user to;
BBI do not have access to any patient data, patient identifiers and SEM readings are securely stored on the Facilities server.
Yes, there is the option to either manually enter a patient ID or simply scan the patient and manually chart their SEM readings.
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