Silhouette v4 System Specifications

A proven skin and wound assessment for clinical practice and clinical research.

Silhouette Star

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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:

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:

System Feature Overview V4
Image Capture Devices
SilhouetteStar

Image capture and non-contact 3D modeling with support for making 3D measurements:

  • Length
  • Width
  • Perimeter
  • Area
  • Mean Depth
  • Max Depth
  • Volume
  • Tissue Type Area %*
  • Area Reduction
SilhouetteLite+

Image capture and non-contact 2D planimetry modeling with support for taking 2D measurements:

  • Length
  • Width
  • Perimeter
  • Area
SilhouetteLite Image capture with no measurement capability
SilhouetteCentral Web App

Secure JPEG image capture from generic cameras with no measurement capability.

 

2D image capture from mobile devices using reference stickers with support for making 2D (planimetry modeling) measurements:

  • Length, width, perimeter, area, area reduction.

3D image capture from mobile devices using reference stickers with support for making 3D measurements:

  • Length, width, perimeter, area, mean depth, max depth, volume, area reduction.
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 the capture device used the following trend graphs are available:

  • Area
  • Area Reduction
  • Max Depth
  • Mean Depth
  • Volume
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 the level of upgrade support
Support Locations and Hours International Support – The support agreement defines hours
SilhouetteStar Scanner
Specifications

Model 2010.xx
SilhouetteStar 2

(Wireless and Wired)

Model 2005.xx
SilhouetteStar 5MP

(Wired)

Model 2000.xx
SilhouetteStar 3MP

(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)
275mm (nominal max)
190mm (typical)
275mm (nominal max)
190mm (typical)
275mm (nominal max)
FOV – Horizontal 41° (nominally 182mm at the typical working distance)

40° (nominally 171mm at the typical working distance)

 

40° (nominally 174mm 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
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

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

Note: Use of the SilhouetteCentral 3D imaging feature requires that images be sent to a Silhouette Surface Modeling
Service hosted in the cloud for processing.

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. Every efforts is made to keep compatibility with previous 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 360px (current iPhone models)

Clinician and Admin User Workflow

Minimum viewport width x height is 360px x 667px for clinical screens (current iPhone models).

Minimum viewport width 768px for administration screens.

Enterprise On-Premises Deployment Platform Requirements
OS Windows Server 2016 or later (2019 or later recommended)
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 2014 SP3 (workgroup, standard, enterprise, web) 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 v6.0 IIS Hosting Bundle (ASP.NET Core v6.0 Runtime + ASP.NET Core Module v2)

NextGen Connect v4.0 or later for integration with EMR Systems.

VC++ 14.0 Runtime

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 is 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.
SilhouetteCentral 2D/3D Imaging
Reference Sticker Color Neon / Fluro Green
Reference Sticker Size 10 mm minimum, 20 mm maximum, typical sizes are either 1/2 inch, 3/4 inch or 14 mm.
Reference Sticker Recommendations Available on request
Mobile Device Support

Apple devices running iOS/iPadOS 13.7 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 8MP rear
camera, have a minimum of 4GB RAM, and meet the screen size specifications above.

ARANZ Medical has tested the 2D and 3D imaging feature with both Apple devices and Android based devices. The
specific list of tested devices is available on request.

Measurement Accuracy Contact ARANZ Medical for accuracy statement relating to SilhouetteCentral 2D and 3D imaging.
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 14.0

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