Silhouette v4 System Specifications
A proven skin and wound assessment for clinical practice and clinical research.
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Whether you work in skin and wound care or research, Silhouette has been designed to make your job easier. First launched in 2007, Silhouette is the most widely used wound assessment, documentation, and management system available and is proven to collect high quality, repeatable, and reliable information. Now with a wireless camera and new applications that operate on Apple devices, Silhouette version 4 provides greater flexibility and usability than ever before.
Wound and Skin Care
Silhouette is used in clinical practice by some of the world’s largest healthcare providers, including the department of Veteran’s Affairs in the US, the NHS in the UK, and many other clinics and hospitals in more than 30 countries. For clinical practice, Silhouette delivers:
- Reliable, accurate, and timely wound documentation
- An easy to use solution for staff
- A non-invasive solution for patients
- Reduced commercial and litigation risk
- Improved patient satisfaction
- Support for secure telehealth workflows with home user access and asynchronous ‘store and forward’ data sharing
- Fewer hospital admissions and visits
- Shorter hospital stays
- A reduction in the total cost of patient care.
Wound and Skin Research
Silhouette’s ability to reliably capture, measure, and manage wound data has been proven in more than 165 clinical studies globally. For clinical research, Silhouette delivers:
- High-quality data to support study endpoints
- Highly accurate, reliable, and repeatable measurements (inter and intra-operability)
- Reliable data collection for pre-clinical through phase IV, post-marketing surveillance, and observational studies
- A scalable solution for studies from one site to 250+ investigator sites
- Immediate access to images, data, and reports for sponsors, CROs, adjudicators, and sites
- One-click PDF assessment reports can be used as source documentation
- Data exports at any time
- An easy to use solution for sites.
| System Feature Overview | V4 |
| Image Capture Devices | |
| SilhouetteStar |
Image capture and non-contact 3D modeling with support for making 3D measurements:
|
| SilhouetteLite+ |
Image capture and non-contact 2D planimetry modeling with support for taking 2D measurements:
|
| SilhouetteLite | Image capture with no measurement capability |
| SilhouetteCentral |
JPEG image capture from generic cameras with no measurement capability Image capture from mobile devices using reference stickers with support for making 2D (planimetry modeling) measurements:
|
| Medical Notes | |
| Wound Tracing |
Manual – determined by clinical judgment Automatic Wound Boundary Detection – optional manual adjustment if necessary |
| Patient Identifiers | Patient Information and Patient Identifiers |
| Patient Notes (recorded per patient) | Investigation History, Medical History, Medication |
| Patient Assessment Notes (recorded per patient, per visit) | Admission Details, Discharge Details, Vital Signs, Related Pain (non-wound), Edema, Factors Affecting Healing |
| Wound Assessment Notes (recorded per wound, per visit) | Anatomical Site, Images, Measurements, Wound Details, Wound Pain, Comments, Wound Etiology |
| Wound Outcomes | Healed, Amputated, Released from Follow-up |
| Multiple Assessment Types | Yes |
| Configuration | Configurable fields and conditional validation rules available** |
| Auto Email Wound Assessments | Yes |
| Customizable Notes | Yes** |
| Analysis and Reporting | |
| Trend Graphs |
Depending on capture device used the following trend graphs are available:
|
| Reporting | PDF Assessment Report |
| Security | |
| Access Control | Username and Password, SAML2 SSO |
| Application Timeout | Configurable |
| Audit Records | Available for logon attempts, changes in patient data, data viewed, and data exported from Silhouette. (Enterprise Deployment Only) |
| Deployment Models | |
| Enterprise – On Premises / Customer Managed | Yes |
| Enterprise – Cloud Hosted / ARANZ Managed | Yes |
| Standalone PC Software | Yes – SilhouetteConnect standalone |
| Integration and Data Export | |
| EMR | Order receipt and results (assessment report, discrete observations, and images) (Enterprise Deployment Only) |
| Export | Images, Wound and Assessment Data |
| Services, Support and Warranty | |
| Established Services Offered | Project Management, System Implementation, Data Management, Technical Training, and Clinical Training |
| Hardware Warranty | Return to base |
| Software Upgrades | Support agreement defines level of upgrade support |
| Support Locations and Hours | International Support – Support agreement defines hours |
| SilhouetteStar Scanner Specifications |
Model 2010.xx (Wireless and Wired) |
Model 2005.xx (Wired) |
Model 2000.xx (Wired) |
| SilhouetteStar is a scanner that captures wound images and non-contact 3D measurements of wounds at the point of care. The images and data captured with SilhouetteStar are uploaded to SilhouetteCentral either over a secure Wi-Fi network (SilhouetteStar 2 only) or via USB cable and SilhouetteConnect. | |||
| Imaging | |||
| Sensor Resolution | 5MP (nominal) | 5MP (nominal) | 3MP (nominal) |
| Working Distance (from the base of the scanner) | 190mm (typical) 280mm (nominal max) |
235mm (typical) 285mm (nominal max) |
190mm (typical) 240mm (nominal max) |
| Depth of Field | -50 mm, +90mm at typical working distance | 100mm | -30 mm, +50mm at typical working distance |
| FOV – Horizontal | 42° (nominally 180mm at the typical working distance) | 170mm min, 230mm max | 42.5° (nominally 183mm at the typical working distance) |
| Aspect Ratio | 4:3 | ||
| Focus | Fixed | ||
| Guided Image Capture | Formation of laser star for consistent imaging | ||
| Exposure | Automatic (Dual LED Flash) | ||
| Picture Format | Exportable in png or jpg formats | ||
| Wound Measurement | |||
| Maximum Wound Size | 250mm x 185mm typical | 230mm x 170mm typical | 250mm x 185mm typical |
| Minimum Wound Size | 2mm x 2mm typical | ||
| Accuracy (95% confidence interval)¹ | Area (Cap measurement): 2% Perimeter: 1% Depth: 5% Volume: 5% |
||
| Precision | Area: 1mm² Perimeter: 1mm Maximum Depth: 1mm Volume: 1mm³ |
||
| Inter-rater Reliability¹ | 1% for area and perimeter, <2% for max depth and volume | ||
| Intra-rater Reliability¹ | 1% for area and perimeter, <2% for max depth and volume | ||
| Timings | |||
| Image Capture Time | 4s typical | 3s typical | 3s typical |
| Image Transfer Time (USB) | 2s typical | Included in time above | Included in time above |
| Image Transfer Time (WiFi) | 4s typical² | – | |
| Scanner Start-up Time |
<25s from off, 1s from sleep |
– | |
| WiFi Connection Time |
< 15s typical |
– | |
| Lighting and Lasers | |||
| Lasers | Class 1 per IEC 60825-1 | ||
| Flash |
High Power LED Flash, approx. 10,000 Lux |
||
| User Interface | |||
| Audio | Shutter + Image Transfer | – (audible feedback via connected computer) | |
| Screen | Patient Name, Patient ID, WiFi Status, Image Transfer Status, System Messages | – (status of camera available via connected computer) | |
| Controls | Single Button | ||
| Capture Guidance | Laser Star | ||
| Power Requirements | |||
| Power Consumption | Compatible with USB 2.0 Power Specifications and USB Battery Charging Specifications v1.2 |
Compatible with USB 2.0 Power Specifications 500mA @ 5V |
|
| Battery Type & Capacity | Li-Ion, 6.5 Wh | – | |
| Battery Shift Life | 8 hours3 | – | |
| Battery Lifetime | > 2 years4 | – | |
| Environmental | |||
| Operating Temperature | 10°C (50°F) min to 30°C (86°F) max | ||
| Storage Temperature | -5°C (23°F) min to 50°C (122°F) max | ||
| Operating Humidity | 0% RH min to 80% RH max | ||
| Lighting5 |
100 lux min – 400 lux nominal – 1000 lux max |
||
| Connectivity | |||
| Offline Support (wired USB use with SilhouetteConnect) | Yes | ||
| USB | USB 2.0 – Uses IP networking over USB (RNDIS) | USB 2.0 | |
| USB Connection Time | <15s | ||
| Online Support (direct WiFi upload to SilhouetteCentral) | Yes | No | |
| WiFi |
802.11 b,g,n (2.4 GHz only) Minimum 14 Mbps uplink to SilhouetteCentral Maximum 300ms round trip latency |
– | |
| WiFi Security |
WPA2 PSK 802.1x Authentication with MAC Authentication Bypass with WPA2 PSK |
– | |
| WiFi TLS Security | Up to TLS 1.2 for connection to SilhouetteCentral | – | |
| Compliance | |||
| Laser | Class 1 Designation – IEC 60825-1 | ||
| EMC | IEC 60601-1-2: 2014 | IEC 60601-1-2: 2007 | |
| Medical Device | IEC 60601 3rd Edition | ||
| Cleaning | |||
| Alcohol (Isopropyl) Based Wipes | Yes | ||
| Bleach Based Wipes | < 1:50 concentration, limited use | ||
| Mild Detergent | Yes | ||
| Water Based Wipes | Yes | ||
| Hydrogen Peroxide Based Wipes | Yes | ||
| Physical | |||
| Dimensions | 100mm x 67mm typical | ||
| Weight | 300g typical | 240g typical | |
| Accessories | |||
| Charger | Yes | – | |
| Cradle | Yes | Yes | |
| Cables |
USB-A to USB-B – 5 m (16′ 5″) |
USB-A to USB-B (Active) – 1.8 m (5′ 11″), 3 m (9′ 10″), 5 m (16′ 5″) |
|
| SilhouetteConnect Specifications – Client Software | |
|
SilhouetteConnect is the software installed on a Windows tablet, laptop or desktop computer. SilhouetteStar connects via USB to a computer with SilhouetteConnect. SilhouetteConnect enables wound assessments to be performed without connection to a network, and the data is synchronized with SilhouetteCentral when a network connection is available. |
|
| Key System Times | |
| Capture to Measurement Complete Time | < 2 minute typical (includes tracing) |
| Synchronization Time |
17s minimum. < 1 minute typical (dependent on database size, active patient list size, number of images, network speed and network reliability) |
| Computing Platform Requirements | |
| Supported Devices | Windows laptop, desktop or tablet |
| Supported Operating Systems |
Windows 10 or Windows 11 Support for Windows 7, 8, and 8.1 where extended support is in place |
| Processor | 2.0GHz Minimum (Multi-core recommended) |
| Disk | 10GB available space recommended minimum for approx. 2,000 images and assessments |
| Memory | 4GB Minimum |
| Browser | N/A |
| Database | SQL Server LocalDb for sync mode or SQL Server Express for standalone mode. The appropriate SQL Server 2014 SP3 is included with the SilhouetteConnect installer. Later versions of SQL Server can be used but must be deployed manually. |
| Software Dependencies | Included with SilhouetteConnect Installer: .NET framework 4.8 and SQL Server 2014 SP3 |
| USB Requirements | USB 2.0 or 3.0 Port |
| Display Resolution | 1024 x 768 Minimum |
| Security | |
| Data-at-rest Encryption | To enable data-at-rest encryption, the software must be deployed using Bitlocker encryption or similar |
| Data-in-transit Encryption | To enable data-in-transit encryption, the software must be synchronized to SilhouetteCentral using the HTTPS protocol |
| SilhouetteCentral Specifications – Server Software | |
|
SilhouetteCentral enables users to review, report, securely share and analyze the wound data collected by SilhouetteStar 2, SilhouetteLite+ and SilhouetteLite applications. SilhouetteCentral is accessed via a web-based application. |
|
| Infrastructure Types | |
| On-Premises | Yes |
| Cloud | Yes |
| Client Software Supported | |
| Web Browser Support |
Chrome, Firefox, Safari, Microsoft Edge. (Each release of SilhouetteCentral is tested on the latest version of these browsers) Note: Microsoft Internet Explorer is not supported. Note: The version of Safari for iOS / iPadOS is linked to the version of iOS / iPadOS. Efforts are made to keep compatibility with older major versions for at least 1 year after a new iOS / iPadOS major versions are released. |
| Thick Client Support |
SilhouetteConnect (Windows) SilhouetteLite (iOS devices) SilhouetteLite+ (iOS devices) |
| Screen Sizes Supported | |
| Home User Workflow |
Minimum viewport width 375px (current iPhone models) |
| Clinician and Admin User Workflow |
Minimum viewport width x height is 375px x 667px for clinical screens (current iPhone models). Minimum viewport width 768px for administration screens. |
| Enterprise On-Premises Deployment Platform Requirements | |
| OS | Windows Server 2012 R2 or later |
| Processor | 2.4 GHz Dual Core, 64 bit minimum |
| Disk | 100 GB Available Space (recommended minimum) |
| Memory |
16 GB Recommended 4 GB Minimum |
| Database |
SQL Server 2012 minimum (workgroup, standard, enterprise) or later An instance of SQL Server (any edition) matching the version deployed with SilhouetteConnect is required if syncing with SilhouetteConnect. |
| Software Dependencies |
Internet Information Services (IIS) with SSL Certificates for HTTPS .NET framework 4.8 ASP.NET Core v3.1 IIS Hosting Bundle (ASP.NET Core v3.1 Runtime + ASP.NET Core Module v2) NextGen Connect v3.8 or later for integration with EMR Systems |
| Network |
Ethernet TCP/IP Connection Static IP Address |
| Security | |
| Username and Password | Configurable password rules and expiration |
| Authentication | SAML2 SSO support with Just-In-Time provisioning, compatible with Active Directory Federated Services (AD FS) |
| Data-in-transit | To support data-in-transit encryption, SilhouetteCentral must be deployed with HTTPS transport |
| Data-at-rest | To support data-at-rest encryption, SilhouetteCentral must be deployed with bitlocker encryption or similar. MS SQL Enterprise Transparent Data Encryption or similar can be used to encrypt databases. |
| 2D Imaging | |
| Reference Sticker Color | Neon / Fluro Green |
| Reference Sticker Size | 10 mm minimum, 20 mm maximum, typical sizes are either 1/2 inch or 14 mm. |
| Reference Sticker Recommendations | Available on request |
| Mobile Device Support |
Apple devices running iOS/iPadOS 13 or greater are supported where they meet the screen size specifications above. Android based mobiles running the latest Google Chrome browser are supported where they have at least an 8 MP rear camera, have a minimum of 4GB RAM, and meet the screen size specifications above. ARANZ Medical has tested the 2D imaging with both Apple devices and Andriod based devices. The specific list of tested devices is available on request. |
| Measurement Accuracy | Contact ARANZ Medical for accuracy statement relating to 2D imaging with SilhouetteCentral. |
| Standards | HL7, Email |
| Key Functionality |
Patient Management Order Management Order Results |
| Key EMR Vendors Supported | Epic*, Cerner, Meditec, VistA Imaging* |
| Data Export | |
| File Export | PDF wound assessment report with images, CSV files |
| SilhouetteLite+ Application and Sensor | |
| SilhouetteLite+ is comprised of an Application and a range finding Sensor for Apple® iPhone® and iPad® iOS devices. SilhouetteLite+ enables users to take wound images, obtain non-contact 2D measurements, and record patient notes on their Apple device. The data collected at the patient’s bedside is synchronized with SilhouetteCentral over a secure connection when available. | |
| Application | |
| iOS Version | 13 (minimum) |
| Device Support | iPhone 6s or newer iPod Touch 7th Gen iPad Mini, iPad Standard, iPad Pro Contact ARANZ Medical for advice on device recommendations. Some iPhones do not allow the sensor to be placed close enough to the iPhones camera. |
| Security | A passcode must be enabled on the device to encrypt data-at-rest. HTTPS must be used on SilhouetteCentral to encrypt data-in-transit. |
| Maximum number of patients | 4,000 |
| Maximum number of images per assessment | 10 |
| Network | |
| Minimum Network Uplink to SilhouetteCentral | 1.5 Mbps |
| Measurement Capabilities | |
| Area, Perimeter and Rulers | Yes |
| Depth and Volume | No |
| Minimum Wound Size | 2mm x 2mm |
| Measurement Accuracy | Contact ARANZ Medical for accuracy statement relating to SilhouetteLite+ |
| Sensor | The SilhouetteLite+ Sensor is attached to an iOS device, close to the iOS device camera, enabling wound measurements to be taken from images. |
| X Offset (horizontal offset between the sensor window to the center of the device camera) |
-12mm minimum +20mm maximum |
| Y Offset (vertical offset between the sensor window to the center of the device camera) |
-12mm minimum +30mm maximum |
| Minimum range to wound | 60mm |
| Maximum range to wound | 400mm |
| Range to wound accuracy | < 6% error |
| Battery | Li-Ion |
| Battery Charging | Inductive charger (Qi) Supplied |
| Battery Shift Life | Approx. 30 calendar days or 80 images – depends on usage pattern |
| Attachment to iOS Device | One time adhesive attachment The Sensor can be attached to a removable case Not all cases are suitable size or material |
| Sensor Size | 90mm x 52mm x 5mm (nominal) |
| Sensor Environment | |
| Operating Temperature | 0°C (32°F) min to 40°C (104°F) max |
| Sensor Charging Temperature | 0°C (32°F) min to 45°C (113°F) max |
| Storage Temperature |
Short Term (< 2 hours): -5°C (23°F) to 60°C (140°F) Medium Term (< 1 month): 0°C (32°F) min to 45°C (113°F) Long Term (> 1 month): 0°C (32°F) to 35°C (95°F) |
| SilhouetteLite Application | |
| SilhouetteLite is an Application designed for Apple® iPhone® and iPad® iOS devices. SilhouetteLite is a simplified Application that enables users to add patients, wound images, and simple notes (without measurements) to SilhouetteCentral. The data collected at the patient’s bedside is synchronized with SilhouetteCentral over a secure network connection when available. | |
| Application | |
| iOS Version | 13 (Minimum) |
| Device Support |
iPhone 6s or newer iPod Touch 7th Gen iPad Mini, iPad Standard, iPad Pro Contact ARANZ Medical for advice on device recommendations |
| Security |
A passcode must be enabled on the device to encrypt data-at-rest HTTPS must be used on SilhouetteCentral to encrypt data-in-transit |
| Maximum Number of Patients | 4,000 |
| Maximum Number of Images per Assessment | 10 |
| Network | |
| Minimum Network Uplink to SilhouetteCentral | 1.5Mbps |
| Measurement Capabilities | |
| Area | No |
| Perimeter | No |
| Rulers | No |
| Depth and Volume | No |
| System Regulatory Approvals | |
| FDA 510k – approval number K070426 ISO 13485:2016 certified CE Mark Health Canada – Therapeutic Products Directorate |
TGA approval (Australia) WAND registration (New Zealand) Singapore regulatory clearance HIPAA compliant system |
Footnotes
* Planned for a future release.
** Configuration of notes available via services in the current release.
1. Based on the material presented at: http://aranzmedical.com/silhouette/wound-measurement-accuracy-study/ using v3 Silhouette for wound tracing and 3MP camera.
2. Transfer via WiFi depends on WiFi network quality.
3. Depends on the usage pattern. The estimate is based on 10 patient assessments over 8 hours, with 5 images per assessment.
4. Depends on usage and charge pattern. The estimate is based on 1 shift and 1 charge per day when in use and with regular monthly charges when in storage.
5. 100 lux is equivalent to a dark, heavily overcast day. 500 lux is equivalent to typical office lighting and 1000 lux is equivalent to TV studio lighting levels. Direct sunlight can easily exceed 30000 lux.
These Specifications are subject to change. Copyright ARANZ Medical 2022. Document Number: 2017-00190 Rev 12.0
