00.09-013 Rev. E – Radlink GPS Tablet User Manual (07/31/2017)
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Radlink GPS Tablet Technical Specifications
Basic Information
Market name:
Radlink GPS Tablet (Galileo Positioning System)
Model:
Radlink GPS Tablet 2200 (Available in 120V & 230V)
Revision Level:
Rev. 2.0
Software Revision Level:
3.8
Purpose:
Picture Archival Communication System (PACS)
Potential Wireless Acquisition types: 1.) Digital Flat Panel Digital Detector (FPD)
-Available in GadOx & CsI Scintillator
2.) Wireless C-Arm Kit (WCA)
Potential Wired Acquisition types:
None
Detector Interface:
Wireless only
Dimensions of GPS Tablet:
9.1” (Width) X 12.3” (Length) X 0.9” (Height Range)
Weight:
3.3 lbs. (GPS Tablet), 84.6 lbs. (Bucky Cart)
Safe Working Load:
1.5 kg
Body Type:
Tablet PC
Operating System:
Windows 10 Professional
Integrated Software:
Radlink Pro Imaging Software Suite & PACS
Includes: ViewPro Application, Preview Images, Image
Acquisition, Image Processing, Image Manipulation,
Overlay Templating, Overlay Line/Angle Measurements
Regulatory Certifications:
Radlink FDA 510(k) #: K142718
External Standards:
IEC 60601-1 (Medical Electrical Equipment Safety)
IEC 60601-1-2 (Medical Electrical Equipment EMC)
IEC 60601-1-6 (Usability for Medical Devices)
Radio Frequency Compliance:
U.S.A. FCC Part 15 Subpart B & Subpart C
Expected Device Lifetime (GPS):
5-7 Years (Without Flat Panel Detector)
Expected Device Lifetime (FPD):
5 Years – (Perkin Elmer FPD)
Accuracy of measurements:
0.2mm
Note: Tolerance is dependent on position of patient
relative to position of DR Panel and X-ray generator for
posterior approach THA procedures and on C-arm
resolution for anterior approach procedures.
Device Classifications:
-
Class II ME Equipment
-
No Sterile Parts, Applied Parts, Detachable Parts, Disposables
-
Not intended for use in oxygen rich environment
-
Suitable for continuous operation mode
-
No High Voltage Terminals or multiple socket outlets
-
GPS Tablet contains no PEMS required for basic safety or essential performance
-
GPS Tablet contains no cooling liquids or oil lubrication systems