Silhouette v3 System Specifications
A proven wound assessment and management solution for both clinical practice and clinical research.
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Whether you work in wound care or wound 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.
Wound 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
- Fewer hospital admissions and visits
- Shorter hospital stays
- A reduction in the total cost of patient care.
Wound Research
Silhouette’s ability to reliably capture, measure, and manage wound data has been proven in more than 70 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 | V3.x |
| Image Capture | |
| Controlled Artificial Lighting | Dual LED Flash |
| Managed Camera Settings | Auto-exposure fixed focus |
| Camera Resolution* | 3MP or 5MP |
| Measurement | |
| Measurement Dimensions | 3-D |
| Image Scale Calculation | Automatic and Non-contact |
| Measurements Calculated | Length, Width, Perimeter, Surface Area, Mean Depth, Max Depth, Volume, Area Reduction, Tissue Type % |
| Wound Tracing | Manual – determined by clinical judgment |
| Medical Notes | |
| Patient Identifiers | Patient Information and Patient Identifiers |
| Patient Notes | Medical History, Diagnostic History |
| Visit Notes | Admission Status, Physicians, Vital Signs, Pain Assessment, Limb Assessment, Healing Factors Assessment |
| Wound Notes | Anatomical Site, Status, Measurements, Wound Etiology, Tissue Types, Tissue Appearance, Infection and Pain |
| Configuration | Configurable fields and conditional validation rules available. (Enterprise Deployment Only) |
| Auto Email Wound Assessments | Yes (Enterprise Deployment Only) |
| Protocol Engine | Guided Workflow (Optional – Enterprise Deployment Only) |
| Customizable Notes | Yes (Enterprise Deployment Only) |
| Analysis and Reporting | |
| Trend Graphs | Area, Area Reduction, Max Depth, Mean Depth, Volume, Tissue Types |
| Reporting | Configurable PDF Assessments |
| Security | |
| Access Control | Username and Password, LDAP (Enterprise Deployment Only) |
| Application Timeout | Configurable |
| Audit Records | Available for logon attempts, synchronizations, camera calibration checks, changes in patient data, data viewed, and data exported from Silhouette. (Enterprise Deployment Only) |
| Integration and Data Export | |
| EMR | Order receipt and response (assessment report) (Enterprise Deployment Only) |
| Export | Images and Assessment Data |
| Services, Support and Warranty | |
| Established Services Offered | Project Management, System Implementation, Data Management, Technical Training and Clinical Training |
| Hardware Warranty | Hardware – Return to base |
| Software Upgrades | Software – Support agreement defines level of upgrade support |
| Support Locations and Hours | International Support – Support agreement defines hours |
*Dependent on the model of SilhouetteStar used.
| SilhouetteStar Scanner Specifications |
Model 2000.xx (SilhouetteStar – wired 3MP) |
Model 2005.xx (SilhouetteStar – wired 5MP) |
Model 2010.xx (SilhouetteStar 2 – wired and Wireless) |
| SilhouetteStar is a non-contact scanner that connects via USB cable to a computer with SilhouetteConnect software to capture wound images and data for 3D wound measurements at the point of care. | |||
| Imaging | |||
| Sensor Resolution | 3MP (nominal) | 5MP (nominal) | 5MP (nominal) |
| Working Distance (from the base of the scanner) | 190mm (typical), 240mm (nominal max) | 235mm (typical), 285mm (max) | 190mm (typical), 280mm (nominal max) |
| Depth of Field | -30 mm, +50mm at typical working distance | 100mm | -30 mm, +90mm at typical working distance |
| FOV – Horizontal | 42.5º (Nominally 183mm at the typical working distance) | 170mm min, 230mm max | 42.5º (Nominally 180mm at the typical working distance) |
| Aspect Ratio | 4:3 | 4:3 | 4:3 |
| Focus | Fixed | Fixed | Fixed |
| Guided Image Capture | Formation of laser lines for consistent imaging | Formation of laser lines for consistent imaging | Formation of laser lines for consistent imaging |
| Exposure | Automatic (Dual LED Flash) | Automatic | Automatic (Dual LED Flash) |
| Picture Format | Exportable in png or jpg formats | Exportable in png or jpg formats | Exportable in png or jpg formats |
| Wound Measurement | |||
| Maximum Wound Size | 250mm x 180mm typical | 230mm x 170mm typical | 250mm x 180mm typical |
| Minimum Wound Size | 2mm x 2mm typical | 2mm x 2mm typical | 2mm x 2mm typical |
| Accuracy (95% confidence interval) Ref: http://www.aranzmedical.com/silhouette/wound-measurement-accuracy-study/ |
Area (Cap measurement): 2% Perimeter: 1% Depth: 5% Volume: 5% |
||
| Precision | Area: 1mm2 Perimeter: 1mm Maximum Depth: 1mm Volume: 1mm3 |
||
| Inter-rater Reliability | 1% for area and perimeter, <2% for max depth and volume | ||
| Intra-rater Reliability | 1% for area and perimeter, <2% for max depth and volume | ||
| Timings | |||
| Image Capture Time | 3s typical | 3s typical | 4s typical |
| Image Transfer Time (USB) | Included in time above | Included in time above | 2s typical (when used in conjunction with SilhouetteConnect)1 |
| Scanner Start-Up Time | – | – | <25s from off, 1s from sleep |
| Lighting and Lasers | |||
| Lasers | Class 1 per IEC 60825-1 | Class 1 per IEC 60825-1 | Class 1 per IEC 60825-1 |
| Flash | High Power LED Flash, 10,000 Lux | High Power LED Flash, 10,000 Lux | High Power LED Flash, 10,000 Lux |
| User Interface | |||
| Audio | Audible feedback via connected computer | Shutter + Image Transfer | |
| Screen | Audible feedback via connected computer | Patient Name, Patient ID, WiFi Status, Image Transfer Status, System Messages | |
| Controls | Single Button | Single Button | Single Button |
| Capture Guidance | Laser Star | Laser Star | Laser Star |
| Power Requirements | |||
| Power Consumption | Compatible with USB 2.0 power specifications 500mA @5V |
Compatible with USB 2.0 power specifications and USB battery charging specifications v1.2 | |
| Battery Type and Capacity | – | – | Li-ion, 6.5 Wh |
| Battery Shift Life | – | – | 8 hrs |
| Battery Lifetime | – | – | >2 years |
| Connectivity | |||
| Offline Support (wired USB with SilhouetteConnect) | Yes | Yes | Yes |
| USB | USB 2.0 | USB 2.0 | USB 2.0 – Uses IP networking over USB (RNDIS) |
| USB Connection Time | <15s | <15s | <15s |
| Online Support (direct WiFi to SilhouetteCentral) | No | No | Yes – ready for use with Silhouette v4 |
| WiFi | – | – | WiFi – ready for use with Silhouette v4 |
| Compliance | |||
| Laser | Class 1 Designation – IEC 60825-1 | Class 1 Designation – IEC 60825-1 | Class 1 Designation – IEC 60825-1 |
| EMC | IEC 60601-1-2: 2007 | IEC 60601-1-2: 2007 | IEC 60601-1-2: 2014 |
| Medical Device | IEC 60601 3rd Edition | IEC 60601 3rd Edition | IEC 60601 3rd Edition |
| Cleaning | |||
| Alcohol (Isopropyl) Based Wipes | Yes | Yes | Yes |
| Bleach Based Wipes | < 1:50 concentration, limited use | < 1:50 concentration, limited use | < 1:50 concentration, limited use |
| Mild Detergent | Yes | Yes | Yes |
| Water Based Wipes | Yes | Yes | Yes |
| Hydrogen Peroxide Based Wipes | Yes | Yes | Yes |
| Physical | |||
| Dimensions | 100mm x 67mm typ. | 100mm x 67mm typ. | 100mm x 67mm typ. |
| Weight | 240g typical | 240g typical | 300g typical |
| Environmental | |||
| Operating Temperature | 10ºC (50ºF) min to 30ºC (86ºF) max | 10ºC (50ºF) min to 30ºC (86ºF) max | 10ºC (50ºF) min to 30ºC (86ºF) max |
| Storage Temperature | -5ºC (23ºF) min to 50ºC (122ºF) max | -5ºC (23ºF) min to 50ºC (122ºF) max | -5ºC (23ºF) min to 50ºC (122ºF) max (short term) |
| Operating Humidity | 0% RH min to 80% RH max | 0% RH min to 80% RH max | 0% RH min to 80% RH max |
| Lighting2 | 100 lux min – 400 lux nominal – 1000 lux max | 100 lux min – 400 lux nominal – 1000 lux max | 100 lux min – 400 lux nominal – 1000 lux max |
| Accessories | |||
| Charger | – | – | Yes |
| Cradle | Yes | Yes | Yes |
| Cables | USB-A to USB-B (Active) 1.8m (5’ 11”), 3m (9’ 10”), 5m (16’ 5”) |
USB-A to USB-B (Active) 1.8m (5’ 11”), 3m (9’ 10”), 5m (16’ 5”) |
USB-A to USB-B 5m (16′ 5″) |
| SilhouetteConnect Specifications – Client Software | |
| SilhouetteConnect is the software that operates on a Windows tablet, laptop or desktop computer. SilhouetteStar connects via USB cable to a computer with SilhouetteConnect. | |
| Key System Times | |
| Successive Image Capture Time | 1.2s typical |
| Capture to Measurement Complete Time | <1 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) |
| Security | |
| Access Control | Username and Password, Use Active Windows Credentials (Enterprise Deployment with LDAP only) |
| Data-at-rest Encryption | Full data-at-rest encryption requires deployment of full disk encryption using Bitlocker or similar. Database is protected with SHA-256 and AES128 encryption. |
| Data-in-transit Encryption | Supports the use of TLS (up to TLS1.2) when synchronizing with SilhouetteCentral. |
| Computing Platform Requirements | |
| Supported Devices | Windows laptop, desktop or tablet |
| Supported Operating Systems | Windows 10 (Support for Windows 7, 8, and 8.1 where extended support is in place) |
| Processor | 2.0 GHz 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 Compact |
| USB Requirements | USB 2.0 or 3.0 Port |
| Display Resolution | 1024 x 768 (minimum) |
| SilhouetteCentral Specifications – Server Software | |
| SilhouetteCentral is an integrated electronic wound information management system that enables providers to review, report, securely share, and analyze data collected by SilhouetteStar and SilhouetteConnect. | |
| Infrastructure Types | |
| Self-Hosted Enterprise | Yes |
| Cloud | Yes – For Clinical Research Customers Only |
| Self-Hosted Enterprise Platform Requirements | |
| OS | Windows Server 2012 (R2) or later. |
| Processor | 2.4 GHz Dual Core Minimum |
| Disk | 100GB Available Space |
| Memory | 16GB Recommended. 4GB Minimum |
| Database | SQL Server 2012 or later |
| Software Dependencies |
Internet Information Services (IIS), IIS URL Rewrite 2.0 module .NET framework 4.7.2 SSL Certificates for HTTPS bindings |
| Network |
Ethernet TCP/IP Connection |
| Security | |
| Username and Password | Configurable password rules and expiration |
| LDAP Authentication | Compatible with Active Directory and Posix LDAP implementations |
| Data-in-transit | To support data-in-transit encryption, SilhouetteCentral must be deployed with SSL certificates. SilhouetteCentral supports up to TLS1.2. |
| Data-at-rest |
To support data-at-rest encryption, SilhouetteCentral must be deployed with full disk encryption using Bitlocker or similar MS SQL Enterprise Transparent Data Encryption or similar can be used to encrypt databases |
| EMR Interfaces | |
| Standards | HL7, DICOM, Email |
| Key Functionality | Patient Management, Order Management, Order Results |
| Key EMR Vendor Supported | Epic, Cerner, Meditec, VistA Imaging |
| Data Export | |
| File Export | Text files (Comma/Pipe/Asterix/Underscore separated), XML (Microsoft Excel), PDF wound assessment report with images |
| Database | Query Database Export (Optional) |
| 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
1. Transfer via WiFi depends on network quality.
2. 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.
