Radlink 2200 User manual

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 1of 16
Radlink GPS Tablet User Manual
Galileo Positioning System™

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 2of 16
Radlink Galileo Positioning System™ Tablet
Product Overview
The Radlink GPS Tablet (Galileo Positioning System™) provides surgeons with real-time feedback on
orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist™
software offer easy-to-follow steps designed to address challenges such as component positioning,
sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer
system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be
viewed on the GPS Tablet during surgery, which surgeons can use to reference against the
intraoperative images captured during the procedure.
For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture
intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For
anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet
using the Radlink Wireless C-Arm Kit.
Table of Contents
GPS Tablet System Overview ........................................................................................................................3
Radlink GPS Tablet Technical Specifications.................................................................................................4
Intended Use.................................................................................................................................................5
FREQUENTLY USED FUNCTIONS.................................................................................................................... 6
System Start-up......................................................................................................................................... 6
System Shut-down ....................................................................................................................................6
Charging the Radlink GPS Tablet...............................................................................................................6
Connect to Radlink Wireless C-Arm Kit.....................................................................................................7
Connect to Radlink Flat Panel Detector.................................................................................................... 7
Using the Radlink GPS Tablet in an Anterior Approach THA Procedure...................................................8
Using the Radlink GPS Tablet in a Posterior Approach THA Procedure.................................................... 9
Charging the DR Panel Battery................................................................................................................11
Preventative Maintenance..........................................................................................................................12
TROUBLESHOOTING....................................................................................................................................13
Safety Signs and Symbols............................................................................................................................14
Warnings for Radlink GPS Tablet Unit ........................................................................................................15

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 3of 16
GPS TABLET SYSTEM OVERVIEW
Wireless C-Arm Kit
Images sent via
Wireless to GPS
Tablet
Images sent via
Wireless to GPS
Tablet
DR Panel & Bucky Cart
(Flat Panel Detector)
Images sent via
Wireless to
Hospital PACS
Hospital PACS &
EMR System

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 4of 16
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

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 5of 16
Overall Electrical Configuration:
Power Consumption: Average of 36 Watts
Input Voltage: 100-240 V (50/60 Hz)
Input Current: 1.0 Amps (AC) [No Fuses]
Output Current: 12V at 2.58 Amps, 5V at 1.0 Amps (AC)
X-ray Energy Range: ~40 kVp ~ 150 kVp
Operating Temperature Range: 41 –104 °F (5 –40 °C)
Humidity Range: 8-85% non-condensing
Atmospheric Pressure Range: 80 kPa –106 kPa
Maximum Altitude of Operation: 2000 meters (or less)
Ingress Water Protection Rating: IP20 –No Liquid Protection, Solids protection 12.5mm
Transport & Storage Atmospheric Conditions:
Temperature Range: -104 –140 °F (-76 –60 °C)
Humidity Range: 8-95% non-condensing
Atmospheric Pressure Range: 80 kPa –106 kPa
INTENDED USE
FDA 510(k) Indications for use
The Radlink GPS is intended for digital image capture use in general radiographic examinations,
whenever conventional screen-film systems may be used. The Radlink GPS allows imaging of
the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are
transmitted from the panel or from a connection to PACS via computer networks or from a
video input port to a personal computer (PC) where they may be displayed, processed, altered,
overlaid with templates, compressed for archiving or transmission via computer networks to
other medical facility sites. The Radlink GPS is not for mammography.
CE Mark (European Union) Intended Use
The Radlink GPS is a computer-based Picture Archival Communication System (PACS) that
receives digital images (processed or raw/unprocessed) from various sources and displays them
to the user for preliminary review. These sources include, but are not limited to, video signal
inputs, wired or wireless transfer of image files from other acquisition systems (e.g. X-Ray Flat
Panel Detector Systems), or images transmitted to the Radlink GPS from other PACS
systems. Using the Radlink GPS, you can manipulate/post-process images, overlay
lines/measurements/templates, store images, and transmit images to other PACS destinations.

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 6of 16
FREQUENTLY USED FUNCTIONS
SYSTEM START-UP
1. The GPS Tablet runs on battery power, so it may not be necessary to plug the unit into
power in order to start the system
2. Press & hold the Power Button on the upper left side of the GPS Tablet screen for 5 seconds
to turn it on. The screen will illuminate within 5 seconds as the computer starts to boot.
3. Enter the password for the GPS User account if your facility has one, otherwise press enter
to continue
4. Open the Radlink Pre-Op Viewer Software by double-clicking the desktop icon “Radlink Pre-
Op” or open the Radlink Pro Imaging Acquisition Software by double-clicking the desktop
icon “Radlink Pro Imaging”
SYSTEM SHUT-DOWN
1. Shut-down the GPS Tablet using standard Windows shut-down procedure
a. Click the Windows icon (‘Start Button’) in the bottom left corner of the desktop
b. Click “Power”
c. Click “Shut Down”
2. Once the GPS Tablet has shut-down via Windows, close the lid and place it back in the
carrying case with all of the accessories for display and power charging cables.
CHARGING THE RADLINK GPS TABLET
1. Plug the power cable from the wall power source into the power port on the side of the GPS
Tablet unit. Charge the Radlink GPS Tablet using the below provided charging cable (Radlink
Part #: 13-14-001-C).
GPS Tablet
Power Button

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 7of 16
CONNECT TO RADLINK WIRELESS C-ARM KIT
1. First, identify the last 4 digits of the Serial Number of the Radlink Wireless C-Arm Kit that
you are trying to connect to. Make sure the device is powered on, and the green power
light is illuminated
2. Once the GPS Tablet is powered-on and Windows has booted, prior to opening the Radlink
Pro Imaging Software, click on the “Internet Access” icon in the bottom right corner of the
desktop
3. Scroll through the list of available wireless networks and select the network titled
“RadlinkWCAXXXX”, where the XXXX represents the last 4 digits of the Wireless C-Arm Kit’s
serial number.
4. The password for the network will be “radlinkwca”
5. Confirm the network shows “No Internet, Secured” under the wireless network name
6. Open the Radlink Pro Imaging software and ensure the system-mode is properly set by
clicking “Manage” in the upper right, and then selecting “Wireless Frame Grabber” for the
System Mode inside the software. Click the “Test” button and verify it is “Ready”.
7. Click “Save Settings” in the bottom right corner, and go to “Select Study” to begin
CONNECT TO RADLINK FLAT PANEL DETECTOR
1. First, identify the 5 digits of the Serial Number of the Radlink Flat Panel Detector that you
are trying to connect to. Make sure the FPD is powered on, and the blue power light is
illuminated on the power button

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 8of 16
2. Once the GPS Tablet is on and Windows has booted, prior to opening the Radlink Pro
Imaging Software, click on the “Internet Access” icon in the bottom right corner of the
desktop
3. Scroll through the list of available wireless networks and select the network titled
“RadlinkDRXXXX”, where the XXXX represents the last 4 digits of the Flat Panel Detector’s
serial number.
4. The password for the network will be “PerkinElmer”
5. Confirm the network shows “No Internet, Secured” under the wireless network name and is
at the top of the list of networks available
6. Open the Radlink Pro Imaging software and ensure the system-mode is properly set by
clicking “Manage” in the upper right, and then selecting “Perkin Elmer” for the System
Mode inside the software. Click “Save Settings” in the bottom right corner.
USING THE RADLINK GPS TABLET IN AN ANTERIOR APPROACH THA PROCEDURE
1. Make sure that your Radlink Wireless C-Arm Kit is on and connected to the wireless internet
network “RadlinkWCAXXXX” where XXXX is the last 4 digits of the Wireless C-Arm Kit serial
number
2. If images need to be pulled from PACS and WiFi access is not available, use the USB
Ethernet LAN adapter with an Ethernet cable to plug into an Ethernet port.
3. Double-click the Radlink Pre-op icon on to access the PACS. Select the pre-operative image
to be used as a reference during the case (if one is available)
4. Double-click the Radlink Pro Imaging to open the acquisition software
5. Click on the row with the patient ID for the study if the order is displayed in the modality
worklist. Otherwise, click New Patient and enter the study information.
6. Once you are in QC Image page, click the Grab Frame tab.
7. C-Arm images will appear in the viewing window for review and measurement
8. If needed, click Pano/Pano Static tab for panoramic function.

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 9of 16
9. Refer to the Surgeon’s Checklist™ user manual for instructions on how to take
measurements with the software.
10. If images need to be sent to PACS and WiFi access is not available, use the USB to Ethernet
accessory cable provided with the GPS Tablet and plug into an Ethernet port.
11. Once cases have been completed for the day, turn off the Wireless C-Arm Kit, shut-down
the GPS Tablet and plug both devices in to charge until their next use
USING THE RADLINK GPS TABLET IN A POSTERIOR APPROACH THA PROCEDURE
Important: Do not position the X-ray generator between the GPS and the DR Panel.
Lead inside the mobile X-ray generator can interfere with the wireless communication,
resulting in a lost connection or the inability of the panel to acquire images.
1. Turn on the DR Panel
To turn on the DR panel, press and hold the power button until the panel turns on.
Once the DR panel has been turned on, follow Steps 2-12 to complete the THA procedure:
2. Double-click the Radlink Pre-op icon on to access the PACS. Select the pre-operative image
to be used as a reference during the case (if one is available)
3. Double-click the Radlink Pro Imaging to open the acquisition software
4. Click on the row with the patient ID for the study if the order is displayed in the modality
worklist. Otherwise, click New Patient and enter the study information.

00.09-013 Rev. E –Radlink GPS Tablet User Manual (07/31/2017) Page 10 of 16
5. The SCAN page will appear. On the body avatar, click the body part to be scanned. The DR
Status on the upper right corner of screen must be in the READY mode. If the DR Status is
not in the READY mode, refer to Troubleshooting on page 15.
6. Note: if you have images in the study, the software goes to “QC Image”, not “Scan”. In this
case, just click the “Scan” button on the top bar to proceed to the acquisition page.
7. Click Start DR.
8. Take the intraoperative X-ray. The image will appear in the viewing window.
9. Use Image Orientation buttons to rotate the image.
10. Use the Image Appearance buttons to Window Level, Zoom in, etc.
11. Refer to the Surgeon’s Checklist™ user manual to take measurements with the software.
12. If it is necessary to shoot another image, click SCAN and Start DR and repeat steps 7-10.
READY Mode Indicator
Start DR
Battery Charge %