Silhouette – Frequently Asked Questions

Our customers say that the key benefits of Silhouette include:

• Reduced admissions to acute care facilities and associated waiting times at acute care facilities
• Increased levels of patient satisfaction and engagement in their treatment
• Improved quality, consistency and a reduction in errors in clinical wound-care documentation
• A reduction in the incidence of reportable pressure ulcers
• A reduction in the length of stay and total cost of care because of measurements that allow evidence-based treatment decisions to be made
• Mitigation of litigation risk through the regular and thorough documentation of wounds as they heal, which include images.

In its simplest form, Silhouette consists of a single endpoint comprising of the:

• SilhouetteStar camera, which has been specifically designed as a medical device for wound imaging
• SilhouetteConnect clinical application, running on a Windows-based computing device

We recommend our Enterprise system for organizations wishing to run multiple Silhouette end-points, to centralize their wound information storage and integrate with their EMR system.

In addition to each Silhouette endpoint, the Enterprise solution consists of the:

• SilhouetteCentral centralized data store, which runs on a server, and to which SilhouetteConnect endpoints connect
• SilhouetteLink, which provides the interface to transfer information to and from your EMR.

Silhouette is very easy to use, the user simply:

• Selects or creates a patient in the software
• Photographs each wound—by positioning the camera above the wound until the laser star forms and then clicking the shutter button
• Traces each wound—then the system automatically calculates all the key measurements
• Adds as many notes as they require into our extensive notes fields that sit alongside the wound image
• Transfers the report to the EMR if required.

Silhouette uses three lasers to measure the profile of a wound-bed and the distance of the camera from the wound. Once the distance of the camera from the wound is known, then the scale of the image can be automatically determined without contact with the wound, and the various wound measurements are calculated.

The SilhouetteStar laser lines follow the surface of the wound-bed, enabling 3-D surface to be modelled.

Knowledge of where the laser lines will appear in the image, for a given distance between the camera and the wound, enables the system to automatically determine the distance of the camera from the wound and therefore the scale of the wound image.

Once the user has captured an image and traced the edges of the wound on the screen, Silhouette automatically calculates the measurements for area, depth and volume.

Upon capture, the images are immediately uploaded to the computer running the Silhouette Application (SilhouetteConnect).

No images are stored on the camera.

With an Enterprise system, the images residing on SilhouetteConnect are uploaded to Silhouette Central when they are synchronised.

Silhouette uses both the HL7 and DiCOM standards to allow Silhouette to connect to a variety of EMR systems.

The interface is bidirectional, allowing Silhouette to receive orders from EMR systems and reports to be passed from Silhouette back to the EMR system.

ARANZ Medical has proven its ability to provide EMR integrations through providing integrations to hospitals running EMR systems such as Cerner, EPIC, Meditech, VISTA (EMR used by the US Department of Veterans Affairs) and Lorenzo.

ARANZ Medical has also assisted hospitals in their transition from one EMR system to another.

The accuracy of Silhouette has been proven in numerous independent research studies, clinical studies and in use in the clinical setting at institutions around the world.

Studies show that any single Silhouette derived measurement is within approximately:

• 2% for area
• 1% for perimeter
• 5% for average depth
• 5% for volume.

Yes, in 2007, the ARANZ Medical Silhouette system gained US Food and Drug Administration (FDA) approval as a Class I Medical Device (510k number K070426). It is classified as 21 CFR 878.4160 – surgical camera and accessories. Silhouette is one, of very few, wound cameras and assessment systems to gain FDA approval. This classification is now FDA exempt.

Yes, Silhouette supports full HIPAA compliance.