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
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 – wired 3MP)
Model 2005.xx
(SilhouetteStar – wired 5MP)
Model 2010.xx
(SilhouetteStar 2 – wired & wireless)
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) 5MP (nominal)
Working Distance From the base of the camera: 190mm (typical), 240mm (nominal max) 235mm (typical), 285mm (max) From the base of the camera: 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
Image Size (px) 2048 x 1536 2560 x 1920 2592 x 1944
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: https://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
Image Times  
Image Capture Time 1.2s typical 1.2s typical 4s typical
Image Transfer Time (USB) Included in time above Included in time above 2s typical (when used in conjunction with SilhouetteConnect)1
Camera boot 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
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 Encryption SHA-256 and AES128 encryption on database
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 2008/ 2008 (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 4.5.2
Microsoft Report Viewer 2010 Redistributable

HTTPS Certificates

Network

Ethernet TCP/IP Connection
Static IP Address

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 HTTPS transport
Data-at-rest

To support data-at-rest encryption, SilhouetteCentral must be deployed with 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 13485:2012 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.

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