8
GENERAL DEVICE DESCRIPTION
The Scanmate Flex is a diagnostic ultrasound device used by professionals in the ophthalmic field
to produce images and measurements of the eye and orbit of adult patients. The system consists
of three main components: an interface module with integrated probe holder, one or more
ultrasonic probes, and the Scanmate software application.
Three different probes are available, at least one of which is required for operation. 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 software. 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 resolution
A
Peripherals:
Mouse/Touchpad, Keyboard
Ports:
(2x) USB 2.0
B
PC Power Supply:
AC/DC Medical Grade Transformer
C
Compatible OS:
Microsoft Windows 7
(32
-
bit / 64
-
bit)
Microsoft Windows 8.1
(32
-
bit / 64
-
bit)
Microsoft Windows 10
(32
-
bit / 64
-
bit)
Microsoft Windows Server 2008 R2
D
(64
-
bit)
Microsoft Windows Server 2012 / 2012 R2
D
(64
-
bit)
Microsoft Windows Server 2016
D
(64
-
bit)
A
The software can be operated using touch controls on systems that have a touch
-
capable
display. Buttons, 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 sections
of this manual detailing B
-
Scan/UBM control for more information.
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 Operating Systems only support installation of the SQL Server database. Refer to
Installation Guide for more information.
Refer to the Scanmate Installation Manual for information on installing and configuring the
software. The installation manual also contains information on backing up and restoring the
database.
DEVICE CLASSIFICATION
Device: System, Imaging, Pulsed Echo, Ultrasonic
Panel: Radiology
Product Code: IYO
Device Class: II
Regulation Number: 21 CFR 892.1560
Device: Diagnostic Ultrasonic Transducer
Panel: Radiology
Product Code: ITX
Device Class: II
Regulation Number: 21 CFR 892.1570
B
C
