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™

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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

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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

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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

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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.

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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

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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

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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.

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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.

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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 %

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CHARGING THE DR PANEL BATTERY
The DR Panel comes with two battery packs and one battery charger. When fully charged, each
battery lasts 2-3 hours. For best results, start each surgical procedure with a fully charged
battery.
To charge the DR Panel battery:
1. With the label at the bottom facing
front and downward, insert the battery
into the charger.
2. When the battery is fully charged, the
four solid green lights will be
illuminated. If the battery is not fully
charged the lights will blink.
To insert the battery into the DR panel:
1. Place the battery in the slot on the DR
panel. The label on the battery should
be on the opposite side of the label of
the panel. Insert the battery all the way
until it clicks.
2. To remove the battery, push the tabs
inward until the battery ejects.

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PREVENTATIVE MAINTENANCE
The Radlink GPS Tablet is designed to require little preventative maintenance over an extended period
of use. The main features that will require attention over time and extended use are as follows:
1. Disinfection & Decontamination periodically with isopropyl alcohol.
(Other cleaning methods should be confirmed with the manufacturer.)
To mitigate the potential spread of infectious diseases, the surfaces of the Radlink GPS should be
thoroughly cleaned as they are taken in and out of high-risk environments (e.g. the operating room),
especially if surfaces come into contact with any equipment or materials from these environments.
Never spray or pour any liquid directly onto the unit.
To clean the monitor screen use a clean, soft, lint-free cloth and a small amount of non-
ammonia, non-alcohol based glass cleaner
2. Scratches, finger grease, dust, chemicals, and ultraviolet light can affect the performance of your
touchscreen. Here are a few things you can do to help protect the screen:
Clean frequently. The GPS Tablet touchscreen has been coated to make it easier to clean. You
don’t need to rub hard to remove fingerprints or oily spots. To avoid scratches, use a soft, lint-
free cloth to gently wipe the screen. You can dampen the cloth with water or an eyeglass
cleaner, but don’t apply liquids directly to your GPS Tablet. Don’t use window cleaner or other
chemical cleaners on your GPS Tablet.
Keep it covered. Close the cover while you’re in transit or not using your GPS Tablet.
Keep it out of the sun. Don’t leave your GPS Tablet in direct sunlight for a long time. Ultraviolet
light and excessive heat can damage the display.
3. Power cords, like any other metal wire or cable, can be weakened or damaged if repeatedly twisted or
bent in the same spot. Here are a few things you can do to keep your power cord from being damaged:
Avoid twisting or pinching your power cord.
Don’t wrap your power cord too tightly, especially around the power brick. Instead, wrap it
using loose coils rather than tight angles.
Inspect your power cord regularly, especially where it joins the power brick.
Avoid pulling on the power cord when unplugging your GPS Tablet. Gently removing the
connector from the charging connector can help prevent damage to your power cord.
If you find any damage on any part of your GPS Tablet charger’s cords, stop using the cord
and contact Radlink Technical support.
4. Check Windows Defender scan history periodically and look for signs of malware detection.
Recommended monthly.
Full system scans can be done manually in addition to automatic daily scans.
5. Updates for Windows OS operating system are tested and approved by Radlink. A list of the most
current approved updates can be found at Radlink.com. Recommended monthly.
Note: Installation of additional software requires administrative privileges provided by Radlink.

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TROUBLESHOOTING
For questions, call Radlink Technical Support:
310-643-6900, ext. 2
Mon-Fri, 6:00 a.m. –5:00 p.m. PST
Problem
Reason
Solution
Frame Grabber is not
pulling images from
the Wireless C-Arm Kit
The video output at the back of the C-Arm
monitor may be damaged or broken
Adjust/repair the video output port or try
using a different C-Arm port.
The signal mode on the Converter on the
Wireless C-Arm Kit is not set to BNC or VGA
mode (depending on your connection)
Press the Input button on the BNC Converter
to switch to BNC mode.
Wireless Frame Grabber is not selected as
the System Mode in the software
1. Open the Radlink Pro Imaging software
and click “Manage”.
2. Make sure the Wireless Frame Grabber is
checked under System Mode
3. Click Save Settings
Touch screen is not
responding
The user may be touching the inside of the
monitor already in one place, blocking the
sensors, and preventing it from registering
another touch simultaneously
Only press on one location of the screen at a
time to ensure consistent registering of every
touch
Computer response
time is slow
The computer may have been shut down
by loss of power rather than via Windows
Restart your computer and allow it to
reconfigure itself
Automatic Windows Updates
Wait for the automatic updates to complete if
the system is too slow
Computer may be out of disk space –
storing too many images
Call Radlink Technical Support.
DR Status light reads
“Initializing” instead of
“Ready”, or DR Panel
(Flat Panel Detector)
will not connect
The wireless communication between the
panel and the GPS Tablet is blocked by a
lead shield, or slowed by obstructions in
the path
Make sure there is no lead (in the X-ray
generator, lead gown, or lead shield) between
the Flat Panel Detector and the GPS Tablet
Flat Panel Detector battery may be low
Replace the battery with a fully charged
battery.
Unstable connection between Flat Panel
Detector and GPS Tablet
1. Close Radlink Pro Imaging software by
clicking Manage Logout.
2. Turn off the DR Panel.
3. Turn on the DR Panel and wait until the
LEDs stop flashing.
4. Launch Radlink Pro Imaging software.
The GPS will not turn
on or will not respond
(or is stuck on a
screen, and will not
respond)
The battery has been depleted because the
GPS was not properly shut down
Plug the GPS Tablet in to charge, and use it
while plugged in if necessary
The Windows Operating System on the
Microsoft Surface Book encountered an
error, and is locked in a nonresponsive
state
If the GPS Tablet will not respond, press and
hold the power button for 35 seconds to hard
reboot the Surface Book
If your device is still not responding, please call
Radlink Technical Support

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SAFETY SIGNS AND SYMBOLS
Refer to Radlink GPS Software User Guide (00.09-007) for detailed software instructions,
including system, error, and fault messages that are generated, unless these messages are self-
explanatory.
European Representative Information
General Warning Sign
Conformité Européenne (CE Mark Clearance)
Radlink’s CE Mark Clearance from Notified Body 0123
Notified Body: TÜV SÜD Product Service GmbH, Ridlerstr. 65. 80339, Munich, Germany
Radlink European Union Representative
Name and Address of Manufacturer
Date of Manufacture
Serial Number
Refer to instruction manual
Input voltage is alternating current (AC)
Earth (ground)
Temperature limit to which this equipment can be safely exposed
Indicates the range of humidity to which this equipment can be safely
exposed
Indicates the range of atmospheric pressure to which this equipment can
be safely exposed
Fragile, handle with care
Keep this equipment dry
0123
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
0123

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WARNINGS FOR RADLINK GPS TABLET UNIT
Radlink Technical Support is the only approved Service
Personnel
Recommended that the user reads Radlink GPS user
manual prior to operating unit
Do not touch the Radlink GPS Tablet and the patient at the
same time
The Radlink GPS Tablet has no “Applied Parts”, or parts
meant for direct patient contact
WARNING - No modification of the Radlink GPS Tablet is
allowed
WARNING - Do not modify the Radlink GPS Tablet without
authorization of the manufacturer
WARNING - If the equipment is modified, appropriate
inspection and testing must be conducted to ensure
continued safe use of the equipment
Other equipment or network/data couplings shall not be
attached to any signal input/output port except for those
which form the GPS Tablet unit
Contraindications: Do not use the Radlink GPS Tablet for
mammography
No parts of the Radlink GPS Tablet shall be serviced or
maintained while in use with a patient
No parts of the Radlink GPS Tablet are suitable for use
within the patient environment
Do not use near water/liquid - unit does not have Ingress
Protection Rating for liquid
To maintain wireless signal strength, do not use near
source of EMC or RF interference
The GPS Tablet (13-14-001) full list of notices and warnings
can be found at www.surface.com/support for the
Microsoft Surface Book
The Wireless Display Adapter (13-14-002) full list of
notices and warnings can be found at
www.surface.com/support for the Microsoft Wireless
Display Adapter
Tablet Wireless LAN Adapter (13-14-004) full list of notices
and warnings can be found at www.asus.com/support/ for
the ASUS USB-AC51
WARNING - There is potential for electromagnetic or other
reciprocal interference between the Radlink GPS Tablet
and other medical electrical devices together. To minimize
the possibility of such interference, keep other medical
electrical equipment away from the Radlink GPS Tablet
unit
Installation is not required for the Radlink GPS Tablet
The Radlink GPS Tablet does not create any “waste
products” during standard use. The device owner should
properly dispose of the GPS Tablet hardware in
accordance with government regulations at the end of the
device life
Position the Radlink GPS Tablet so the mains plug is readily
accessible for quick disconnection from the power supply
The Radlink GPS Tablet uses batteries. The device owner
should properly dispose of the GPS Tablet’s batteries in
accordance with government regulations at the end of the
device life.
WARNING - The Radlink GPS Tablet is not configurable (or
reconfigurable)
An additional multiple socket-outlet or extension cord
shall not be connected to the Radlink GPS Tablet while
plugged in and charging
Only connect items that have been specified as part of the
Radlink GPS Tablet or have been specified as being
compatible with the unit.
To disconnect the Radlink GPS Tablet from power, remove
the quick-connect power cable on the right side of the
keyboard.
The accessories of the Radlink GPS Tablet and
modifications during the actual service life require
evaluation to the requirements of IEC 60601-1.
WARNING –To prevent falling hazards and potential
damage, hold the Radlink GPS Tablet firmly or place
securely on tabletops and desks

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Radlink, Inc.
www.radlink.com
[phone]
815 N. Nash St.
El Segundo, CA 90245