DGH TECHNOLOGY SCANMATE FLEX - General Device Description; Device Classification

8
GENERAL DEVICE DESCRIPTION
The Scanmate Flex is a diagnosc ultrasound device used by professionals in the ophthalmic eld
to produce images and measurements of the eye and orbit of adult paents. The system consists
of three main components: an interface module with integrated probe holder, one or more
ultrasonic probes, and the Scanmate soware applicaon.
Three dierent probes are available, at least one of which is required for operaon. The available
probes include an A-scan probe, B-scan probes and a UBM probe. The probe or probes in use are
plugged into the interface module, which is, in turn, connected via a USB cable to a PC running
the Scanmate soware. The minimum PC requirements are as follows:
Minimum Recommended
Processor: 2.0 GHz 3.0+ GHz
Architecture: 32-bit or 64-bit 64-bit
Memory: 2 GB RAM 4 GB RAM
Hard Drive: HDD or SSD SSD
Storage Space: 128 GB 500 GB
Display: 1024 x 768 resoluon
A
Peripherals: Mouse/Touchpad, Keyboard
Ports: (2x) USB 2.0
B
PC Power Supply: AC/DC Medical Grade Transformer
C
Compable OS: Microso Windows 7 (32-bit / 64-bit)
Microso Windows 8.1 (32-bit / 64-bit)
Microso Windows 10 (32-bit / 64-bit)
Microso Windows Server 2008 R2
D
(64-bit)
Microso Windows Server 2012 / 2012 R2
D
(64-bit)
Microso Windows Server 2016
D
(64-bit)
A
The soware can be operated using touch controls on systems that have a touch-capable
display. Buons, sliders and combo boxes can be operated by touching the screen. B-Scan/
UBM measurement tools can be operated using touch controls. Zooming and panning of
zoomed B-Scan/UBM images can also be controlled through touch input. Refer to the secons
of this manual detailing B-Scan/UBM control for more informaon.
1 port used for USB interface, 1 port used for footswitch.
WARNING: PCs connected to DGH devices must be isolated from ground using a medical
grade power supply.
D
Server Operang Systems only support installaon of the SQL Server database. Refer to
Installaon Guide for more informaon.
Refer to the Scanmate Installaon Manual for informaon on installing and conguring the
soware. The installaon manual also contains informaon on backing up and restoring the
database.
DEVICE CLASSIFICATION
Device: System, Imaging, Pulsed Echo, Ultrasonic
Panel: Radiology
Product Code: IYO
Device Class: II
Regulaon Number: 21 CFR 892.1560
Device: Diagnosc Ultrasonic Transducer
Panel: Radiology
Product Code: ITX
Device Class: II
Regulaon Number: 21 CFR 892.1570
B
C