Silhouette v3 System Specifications

A proven wound assessment and management solution for both clinical practice and clinical research.

Silhouette Star

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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:

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:

System Feature Overview V3.x
Image Capture
Guided Image Capture Formation of laser star for consistent imaging
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
Specifications – Camera
Model 2000.xx
SilhouetteStar 3MP)
Model 2005.xx
(SilhouetteStar 5MP)
SilhouetteStar is a non-contact camera 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)
Working Distance 235mm (typical), 285mm (max) 235mm (typical), 285mm (max)
Depth of Field 60 mm 100 mm
FOV – Horizontal 180mm min, 250mm max 170mm min, 230mm max
Aspect Ratio 4:3 4:3
Focus Fixed Fixed
Exposure Automatic Automatic
Picture Format Exportable in png or jpg formats Exportable in png or jpg formats
Image Size (px) 2048 x 1536 2560 x 1920
Wound Measurement
Maximum Wound Size 250mm x 180mm typical 230mm x 170mm typical
Minimum Wound Size 2mm x 2mm typical 2mm x 2mm typical
Accuracy (95% confidence interval)
Ref: https://www.aranzmedical.com/silhouette/wound-measurement-accuracy-study/
Area (Cap measurement): 2%
Perimeter: 1%
Depth: 5%
Volume: 5%
Area (Cap measurement): 2%
Perimeter: 1%
Depth: 5%
Volume: 5%
Precision Area: 1mm2
Perimeter: 1mm
Maximum Depth: 1mm
Volume: 1mm3
Area: 1mm2
Perimeter: 1mm
Maximum Depth: 1mm
Volume: 1mm3
Inter-rater Reliability 1% for area and perimeter, 2% for max depth and volume 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 1% for area and perimeter, 2% for max depth and volume
Image Times
Image Capture Time 1.2 s typical 1.2 s typical
Image Transfer Time (USB) Included in time above Included in time above
Lighting and Lasers
Lasers Class 1 per IEC 60825-1 Class 1 per IEC 60825-1
Artificial Lighting Dual torch mode LED Dual torch mode LED
Flash High Power LED Flash, 10,000 Lux High Power LED Flash, 10,000 Lux
User Interface
Audio N/A1 N/A1
Screen N/A1 N/A1
Controls Single Button Single Button
Capture Guidance Laser Star Laser Star
Power Requirements
Power Consumption 500mA @ 5V 500mA @ 5V
Connectivity
USB USB 2.0 USB 2.0
Compliance
Laser Class 1 Designation – IEC 60825-1 Class 1 Designation – IEC 60825-1
EMC IEC 60601-1-2: 2007 IEC 60601-1-2: 2007
Medical Device IEC 60601 3rd Edition IEC 60601 3rd Edition
Cleaning
Alcohol (Isopropyl) Based Wipes Yes Yes
Bleach Based Wipes < 1:50 concentration, limited use < 1:50 concentration, limited use
Mild Detergent Yes Yes
Water Based Wipes Yes Yes
Hydrogen Peroxide Based Wipes Yes Yes
Physical
Dimensions 100mm x 67mm typ. 100mm x 67mm typ.
Weight 240g typical 240g typical
Environmental
Operating Temperature 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
Operating Humidity 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
Accessories
Cables USB-A to USB-B (Active)
1.8 m (5’ 11”), 3 m (9’ 10”), 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 Specifications
SilhouetteConnect is the software that operates on a tablet, laptop or desktop computer with Windows 7 or later.
SilhouetteStar connects via USB cable to a computer with SilhouetteConnect.
Key System Times
Successive Image Capture Time 1.2 s typical
Capture to Measurement Complete Time < 1 minute typical (includes tracing)
Synchronization Time 17 s 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 Encryption SHA-256 and AES128 encryption on database
Computing Platform Requirements
Supported Devices Windows laptop, desktop or tablet
Supported Operating Systems Windows 7,8,8.1 or 10
Processor 2.0 GHz
Disk 10 GB available space
Memory 4 GB recommended, 2 GB 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 Specifications
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 Clinical Trials Only
Self-Hosted Enterprise Platform Requirements
OS Windows Server 2008/ 2008 (R2) or later. 2012 R2 64-Bit Recommended
Processor 2.4 GHz Dual Core Minimum
Disk 100 GB Available Space
Memory 16 GB Recommended. 4 GB Minimum
Database SQL Server 2012 minimum, 2014 recommended
Software Dependencies Internet Information Services (IIS), IIS URL Rewrite 2.0 module .NET framework 4.5.2
Microsoft Report Viewer 2010 Redistributable
Security
Username and Password Configurable password rules and expiration
LDAP Authentication Compatible with Active Directory and Posix LDAP implementations
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 13485:2012 certified
CE Mark
Health Canada – Therapeutic Products Directorate
TGA approval (Australia)
WAND registration (New Zealand)
Singapore regulatory clearance
HIPAA compliant system

Footnotes
1. The camera uses the Silhouette Connect PC to play shutter sounds, display live previews and review image captures.
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.