Silhouette v4 System Specifications

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

Silhouette Star

Download A4 (PDF)Download US Letter (PDF)

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 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 taking 2D measurements:

  • Length
  • Width
  • Perimeter
  • Area
SilhouetteLite Image capture with no measurement capability
Medical Notes
Wound Tracing Manual – determined by clinical judgment
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
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:

  • Area
  • Area Reduction*
  • Max Depth
  • Mean Depth
  • Volume
Reporting PDF Assessment Report
Security
Access Control Username and Password, LDAP*
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)
Deployment Models
Enterprise – On Premises Yes
Enterprise – Cloud Hosted Yes – for clinical research customers only
Standalone PC Software Yes – SilhouetteConnect standalone
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 Return to base
Software Upgrades Support agreement defines level of upgrade support
Support Locations and Hours International Support – Support agreement defines hours
SilhouetteStar
Specifications – Camera
Model 2010.xx
SilhouetteStar 2 – (Wireless and Wired)
Model 2001.xx
SilhouetteStar – (Wired)
SilhouetteStar is a camera that captures wound images and non-contact 3D measurements of wounds at the point of care. The images and data captured with SilhouetteStar 2 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) 3MP (nominal)
Working Distance From the base of the camera:
190mm (typical)
280mm (nominal max)
From the base of the camera:
190mm (typical)
240mm (nominal max)
Depth of Field -50 mm, +90mm at typical working distance -30 mm, +50mm at typical working distance
FOV – Horizontal 42° (nominally 180mm at the typical working distance) 42.5° (nominally 183mm at the typical working distance)
Aspect Ratio 4:3 4:3
Focus Fixed Fixed
Guided Image Capture Formation of laser star for consistent imaging Formation of laser star for consistent imaging
Exposure Automatic (Dual LED Flash) Automatic (Dual LED Flash)
Picture Format Exportable in png or jpg formats Exportable in png or jpg formats
Image Size (px) 2592 x 1944 2048 x 1536
Wound Measurement
Maximum Wound Size 250mm x 185mm typical 250mm x 185mm typical
Minimum Wound Size 2mm x 2mm typical 2mm x 2mm typical
Accuracy (95% confidence interval)¹

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 Reliability¹ 1% for area and perimeter, <2% for max depth and volume 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 1% for area and perimeter, <2% for max depth and volume
Image Times
Image Capture Time 4s typical 2s typical
Image Transfer Time (USB) 2s typical (when used in conjunction with SilhouetteConnect) Included in time above
Image Transfer Time (WiFi) 4s typical²
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
Flash High Power LED Flash, approx. 10,000 Lux 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 Single Button
Capture Guidance Laser Star 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
Battery Type & Capacity Li-Ion, 6.5 Wh
Battery Shift Life 8 hours3
Battery Lifetime > 2 years4
Connectivity
Offline Support (wired USB use with SilhouetteConnect) Yes Yes
USB USB 2.0 USB 2.0
USB Connection Time <15s <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, WPA-2 Personal
WiFi Connection Time < 15s typical
Compliance
Laser Class 1 Designation – IEC 60825-1 Class 1 Designation – IEC 60825-1
EMC IEC 60601-1-2: 2014 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 typical 100mm x 67mm typical
Weight 300g typical 240g typical
Environmental
Operating Temperature 10°C (50°F) min to 30°C (86°F) max 10°C (50°F) min to 30°C (86°F) max
Storage Temperature -5°C (23°F) min to 50°C (122°F) max -5°C (23°F) min to 50°C (122°F) max
Operating Humidity 0% RH min to 80% RH max 0% RH min to 80% RH max
Lighting5 100 lux min – 400 lux nominal – 1000 lux max 100 lux min – 400 lux nominal – 1000 lux max
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
Successive Image Capture Time 3s typical
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

Support for Windows 7, 8, and 8.1 where extended support is in place

Processor 2.0 GHz Minimum
Disk 10 GB available space (Recommended Minimum)
Memory 4 GB Minimum
Browser N/A
Database Included in SilhouetteConnect (SQL Express 2014)
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 – for Clinical Research Customers Only
Client Software Supported
Web Browser Support Chrome, Firefox, Safari, IE, Microsoft Edge
Thick Client Support

SilhouetteConnect (Windows)

SilhouetteLite (iOS devices)

SilhouetteLite+ (iOS devices)

Enterprise On-Prem 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 2014 SP2 (express, workgroup, standard or enterprise) is required if syncing with SilhouetteConnect.

Software Dependencies

Internet Information Services (IIS)

.NET framework 4.5.2

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 encryption 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 Vendors Supported Epic*, Cerner*, Meditec*, VistA Imaging*
Data Export
File Export PDF wound assessment report with images
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 11 (minimum)
Device Support iPhone 5s or newer
iPod Touch 6th 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 1.5 Mbps
Measurement Capabilities
Area Yes
Perimeter Yes
Rulers Yes
Depth No
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
Connection to iOS Device Bluetooth 4 (Bluetooth LE)
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 11 (Minimum)
Device Support

iPhone 5s or Newer

iPod Touch 6th 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 No
Volume No
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

* 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 20 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.
5. 1
00 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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