Varex Imaging XRpad2 4343 User manual

XRpad2 4343 Digital X-ray
Detector User Manual
Before using the X-ray detector, be sure to read this manual thoroughly along with any
other manuals for the software and other system components. Keep this manual where it
is easily accessible.
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Before You Begin XRpad2 4343
Before You Begin
•To avoid personal injury or product damage, read the manual and all accompanying
information carefully before installing and using the X-ray detector.
•The X-ray detector is intended for use by trained and qualified professional personnel who
are knowledgeable with the use of X-ray detectors, X-ray systems, and electrical equipment.
•The user is responsible for using and maintaining the detector according to prescribed
installation, usage, maintenance, handling, and storage specifications. To keep the detector
and its accessories in a safe and proper condition, only trained and qualified professional
person(s) shall be in charge of maintenance.
•X-ray imaging, image processing, image acquisition, and data storage must be performed in
accordance with all applicable laws. The user is also responsible for compliance to laws
pertaining to the privacy of image data.
•In no event is Varex liable for direct, indirect, or consequential injury, damage, or loss of
equipment operation time or image data arising from the use of the X-ray detector, its
components, and/or accessories.
Protection Against Ionizing Radiation
•Exposure of any part of the human body to X-radiation may be harmful to health. Whenever
X-ray equipment, ionizing, or radioactive sources are in use, appropriate safety precautions
and measures shall be instituted, and all regulatory requirements must be met. It is the
responsibility of the X-ray system installer, operator, and user to comply with applicable
requirements.
•The X-ray detector does not contain a primary barrier for X-rays or Gamma rays. The X-ray
system installer or X-ray system manufacturer must provide the necessary protection based
on the X-ray system’s intended use.
•For portable applications, the X-ray system installer or X-ray system manufacturer must
provide the necessary training for operators to protect themselves, patients, and surrounding
persons.
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XRpad2 4343 For Your Safety
For Your Safety
To avoid personal injury or product damage, read this manual and all accompanying informa-
tion carefully before handling, installing, or using the X-ray detector. Follow all instructions,
warnings, and cautions in this manual and all warnings and cautions printed on the warning
label. Ignoring instructions, warnings, or cautions in the handling, installing, or using of the
detector may result in personal injury, death, or product damage. Keep this manual for future
reference.
Meaning of Alerts and Notes
DANGER This indicates a potentially hazardous situation which, if ignored, will
result in severe personal injury, death, or substantial product damage.
WARNING This indicates a potentially hazardous situation which, if ignored, may
result in severe personal injury, death, or substantial product damage.
Caution This indicates a potential hazardous situation which, if ignored, may
result in minor or moderate personal injury or damage to the product.
Note This emphasizes or supplements important information about the
main text.
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Installation and Environment of Use
WARNING The X-ray detector is intended to be installed, maintained, and used by
qualified professional personnel who are trained and qualified in the
installation, maintenance, and use of X-ray equipment.
WARNING Do not operate the X-ray detector in or around flammable gases, gas mixtures,
liquids, chemicals, or other substances. Ignoring this warning may result in
explosion, fire, or electric shock, which may result in severe personal injury,
death, or substantial product damage.
WARNING The AED mode requires a sufficient X-ray dose rate to the detector
surface to trigger image acquisition. The required dose rate can vary at
different use conditions. The system integrator must evaluate the AED
operation with the complete X-ray setup in order to secure the proper
image acquisition in AED mode.
Depending on conditions, including but not limited to, environmental
conditions, installation method, X-ray system setup, and subject to be
imaged, the use of AED mode may result in false trigger or no trigger
of X-ray image acquisition. The risk of false trigger or no trigger of
X-ray image acquisition must be assessed for the specific intended use
and application. For the most reliable image acquisition method, use
of the external or software trigger mode to synchronize with the X-ray
source is recommended.
WARNING Do not connect the X-ray detector or the interface-and-power unit
(IPU-2) to any component or accessory other than the manufacturer’s
specified components and accessories. Ignoring this warning may
result in explosion, fire, or electric shock, which may result in severe
personal injury, death, or substantial product damage.
WARNING Do not modify or alter the X-ray detector, its components, or
accessories. Ignoring this warning may result in explosion, fire, or
electric shock, which may result in severe personal injury, death, or
substantial product damage.
WARNING The X-ray detector shall only be used with its approved Varex
accessories and replacement parts. Product certification and warranty
are rendered void if any modification or alteration to the product is
made, or any instruction, warning, or caution is not followed. It is
important that the X-ray detector is not directly connected to the
installed network. Connection of the X-ray detector directly with the
installed computer network may disturb the IT environment. The
imaging workstation and the Wi-Fi access point must comply with
IEC 60601-1 or IEC 60950-1.
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XRpad2 4343 For Your Safety
WARNING The detector is not designed to control X-ray dose. The system
integrator is responsible for controlling the X-ray radiation.
WARNING Connection of the X-ray detector to the installed IT network that
includes other equipment could result in previously unidentified risk
to patients, operators or third parties. the responsible organization
should identify, analyze, evaluate and control these risk. Subsequent
changes to the IT-network could introduce also new risks and require
additional analysis.
Caution Do not operate the X-ray detector in a location with the following
conditions.
•Close to fluid or places where fluid is used
•Close to heat sources, such as a heater
•High temperature environment
•High humidity environment
•High condensation environment
•Extreme cold environment
•Dusty environment
•Salty or sulphurous environment
•Near a vibrating environment
•Environment where there is insufficient air circulation to enable the X-ray
detector, and power supply to dissipate heat.
Ignoring this caution may result in personal injury or damage to
the product.
Caution When using the X-ray detector in Automatic Exposure Detection
(AED) mode, the temperature may increase due to the heat generated
by the X-ray detector electronics to support the AED mode. Follow the
integration guide and instructions for the use of the X-ray detector in
AED mode. Ignoring this caution may result in personal injury or
damage to the product.
Caution Monitor the temperature of the X-ray detector and allow the detector to
cool down when the temperature of the detector gets hot. Ignoring this
caution may result in personal injury or damage to the product.
Caution An Image Quality Test or Customer Acceptance test should be
performed before the detector is used for the first time with patients.
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Interface and Power Unit and Cables
WARNING Be sure to turn OFF the power of the X-ray detector, including turning
off the power supply or removing the battery (if applicable) before
servicing, maintaining, connecting, or disconnecting the cables or
accessories.
Do not touch the power supply, Battery Pack, X-ray detector, cable,
connector, or any other electrical component or equipment with wet
hands. Ignoring this warning may cause electrical shock, which may
result in severe personal injury, death, or substantial product damage.
WARNING Disconnect the cables by pulling on the connector and not the cable
itself. Ignoring this warning may cause electrical shock, which may
result in severe personal injury, death, or substantial product damage.
WARNING Do not modify the cables or subject the cable to external stress or
damage. Avoid placing anything heavy, including the detector, on the
cable, stepping on the cable, pulling the cable, or subjecting the cable
to excessive bending or bundling. Ignoring this warning may cause
cable failure resulting in electrical shock, which may result in severe
personal injury, death, or substantial product damage.
WARNING Do not turn ON the power supply or X-ray detector when
condensation is on the X-ray detector or any of its components or
accessories. Ignoring this warning may cause electrical shock, which
may result in severe personal injury, death, or substantial product
damage.
WARNING To avoid risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
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XRpad2 4343 For Your Safety
Handling
WARNING Never disassemble, modify, or alter the X-ray detector, its components,
Battery Pack, battery charger, or accessories. Ignoring this warning
may cause electrical shock and/or unknown hazards, which may result
in severe personal injury, death, or substantial product damage.
WARNING Do not touch the interface and power unit or cable and the patient at
the same time. Do not let the patient touch the interface and power
unit or cable. Ignoring this warning may cause electrical shock and/or
unknown hazards, which may result in severe personal injury, death,
or substantial product damage.
Caution Place the X-ray detector horizontally on a flat, stable surface. If the
X-ray detector is placed vertically or in any tilted position, the X-ray
detector must be securely placed in the Bucky tray or securely fastened
to the X-ray detector enclosure or support structure. Ignoring this
caution may result in personal injury or damage to the product.
Caution Do not exceed the maximum uniform load weight of 150 kg
distributed across the surface of the X-ray detector.
Caution Do not exceed the maximum load weight of 100 kg distributed on an
area of 40 mm in a diameter of the X-ray detector surface.
Caution Do not drop the X-ray detector. If the X-ray detector is dropped,
remove the X-ray detector from service, and immediately ask your
establishment’s safety representative to verify or re-validate the
proper function of the X-ray detector prior to resuming use of the
detector. Further use under abnormal conditions may result in severe
personal injury, death, or substantial product damage.
Caution Do not expose the backside of the detector with X-rays. Always use the
top side of the detector for examinations.
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For Your Safety XRpad2 4343
Battery
WARNING Do not use the battery pack if the casing is broken or if it emits an
unusual odor, smoke, or excessive heat, or if it leaks any substance.
Avoid contact with any substance seeping from the battery pack. If
any fluid touches your skin or eyes, wash the affected area with clean,
running water and immediately seek medical attention.
WARNING The cells within the battery pack contain toxic substances. Do not
attempt to open the battery packs. Do not insert any object into the
battery pack or use any device to pry at the battery pack casing.
Attempting to open the battery pack casing will damage the casing,
which could cause the LBP to release toxic and harmful substances
causing injuries such as electric shock or burns, or cause a fire, and
will render the pack unusable.
WARNING Observe and follow all safety information in this manual and on the
warning label found on the battery pack. Ignoring a warning may
result in personal injury or damage to the product.
WARNING Use only charging devices approved by device manufacturer, and
never attempt to bypass or override their charging protection circuits.
WARNING Keep out of reach of children.
WARNING Remove the battery pack if the X-ray detector is not likely to be used
for some time.
WARNING Do not submerge the battery pack in water or other liquid.
WARNING Do not charge the battery pack near flammable materials.
WARNING Do not connect the battery pack to an electrical outlet directly, or to
any other electrical source not described in the manual.
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XRpad2 4343 For Your Safety
WLAN
WARNING Do not drop or hit the battery against hard objects since this may cause
damage to the LBP and risk release of the battery toxic and harmful
substances, causing injuries such as electric shock or burns or causing
a fire, and will render the battery pack unusable.
WARNING Do not use the battery charger in the patient environment.
Caution There is a risk of explosion, personal injury, or damage to product if
the battery pack is replaced by non-OEM approved components.
WARNING Do not obstruct the detector antenna. If it is obstructed by metal,
wood, or a human body, the wireless communication can be slowed
down or disconnected.
WARNING Follow the laws and regulations for each country, and select the
regional code accordingly.
WARNING Do not use the detector in aircraft because there is a potential affect to
aviation systems.
WARNING Do not modify or alter the detector as this can violate the certification
of the Radio Law.
Caution Use WLAN access point devices to get the best communication
performance.
Caution The electromagnetic emission of the detector may influence
implantable medical devices like pacemakers. Check the information
for these devices.
Caution Use a Wi-Fi friendly environment and avoid Bluetooth devices,
mobile phones, and other Wi-Fi devices close to the detector or router.
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Automatic Exposure Detection (AED) Mode
WARNING The AED mode requires a sufficient X-ray dose rate to the detector
surface to trigger image acquisition. The required dose rate can vary at
different use conditions. The system integrator must evaluate the AED
operation with the complete X-ray setup in order to secure the proper
image acquisition in AED mode.
Depending on conditions, including but not limited to, environmental
conditions, installation method, X-ray system setup, and subject to be
imaged, the use of AED mode may result in false trigger or no trigger
of X-ray image acquisition. The risk of false trigger or no trigger of
X-ray image acquisition must be assessed for the specific intended use
and application. For the most reliable image acquisition method, use
of the external or software trigger mode to synchronize with the X-ray
source is recommended.
WARNING The external sync mode is the default acquisition mode, and the
detector needs to switch into the AED mode to use the Auto Exposure
detection. It is important that a settling time for the AED is
implemented by the system integrator. If the settling time is too short,
the image can show artifacts.
WARNING The AED on-time is limited and should be turned off directly after
acquiring the image. Staying longer in AED mode will reduce the
battery duty cycle and heat up the detector.
WARNING Do not apply any, handling, loading, mechanical shock, or electronic
noise to the detector while it is in AED mode. These actions can start
an unwanted acquisition (false trigger). If a false trigger is applied to
the detector, the detector will not be able to react on a real X-ray
exposure until it has acquired the false image.
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XRpad2 4343 For Your Safety
If a Problem Occurs
WARNING If any abnormal condition, such as smoke, fumes, or strange sounds,
is evident, turn off the X-ray detector, turn off and unplug the power
supply from the AC outlet, and immediately ask your establishment’s
safety representative to contact your dealer, distributor, or device
manufacturer.
Further use under abnormal conditions may result in severe personal
injury, death, or substantial product damage.
WARNING When liquid has been spilled into or on any part of the X-ray detector
or power supply (if applicable), or when the X-ray detector, its
component, or accessory is dropped, unplug the power supply from
the AC outlet, and immediately ask your establishment’s safety
representative to contact your dealer, distributor, or device
manufacturer.
Further use under abnormal conditions may result in severe personal
injury, death, or substantial product damage.
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Maintenance and Inspection
WARNING Turn off the power of the X-ray detector when the inspections
indicated in this manual are going to be performed. Ignoring this
warning may result in electric shock, which may result in severe
personal injury, death, or substantial product damage.
WARNING When the X-ray detector system is going to be cleaned, turn off the
X-ray detector and remove the battery pack. If the X-ray detector is
connected to a power supply, turn off the power switch and/or unplug
the power supply cable from the AC outlet. If the X-ray detector is
battery powered, remove the battery. Never use thinner, benzine,
acetone, or other flammable cleaning agents. Ignoring this warning
may result in explosion, fire, or electric shock, which may result in
severe personal injury, death, or substantial product damage.
WARNING The X-ray detector must be repaired by X-ray detector
manufacturer-authorized personnel only. Ignoring this warning may
result in explosion, fire, electric shock, or unknown hazards, which
may result in severe personal injury, death, or substantial product
damage.
Caution Follow the manufacturer’s recommendations for inspecting the X-ray
detector before use.
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Table of Contents
1.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.0 Detector Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.0 This section intentionally left blank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.0 This section intentionally left blank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.0 Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
6.0 Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
7.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
8.0 Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.0 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
10.0 Description of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10.1 Overview of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10.2 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.3 X-ray Detector Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10.4 X-ray Detector Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.5 X-ray Detector Accessories and Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . 16
10.5.1 Rechargeable Battery Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.5.2 XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
10.6 Minimum System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
10.7 Operating the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
10.7.1 Wired X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
10.7.2 Wireless X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
10.7.3 Before Using the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
10.7.4 Powering On the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
10.7.5 Powering Off the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
10.7.6 Temperature Warning Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
10.7.7 General Workflow for Acquiring an Image. . . . . . . . . . . . . . . . . . . . . . . . 32
11.0 Inspection and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
11.1 Daily Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
11.1.1 Before Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
11.1.2 After Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
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11.1.3 After Turning Off the Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
11.2 Monthly Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
11.3 Yearly Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
11.4 Calibrating the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
11.5 Cleaning and Disinfecting Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
11.5.1 Material-Compatible Chemicals for Cleaning and Disinfecting . . . . . . 38
11.5.2 Cleaning the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
11.5.3 Disinfecting the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
11.6 Error Messages and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
12.0 After-Sales Service for Varex Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
13.0 Disposing of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
14.0 Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
14.1 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
14.2 Declaration of Conformity for European Union
(and EEA)46
14.3 Federal Communication Commission Interference Statement (US) . . . . . . . . . . . 48
14.4 Industry Canada Statement (English) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
14.5 Industrie Canada – Déclaration (Français). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
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List of Figures
Figure 1 X-ray Detector (Front View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Figure 2 Typical Detector Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 3 DQE vs Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure 4 MTF vs Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 5 Plot of Characteristic Curve (Signal vs Exposure). . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 6 Dimensions for the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 7 Patient Vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Figure 8 XRpad2 LBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 9 Removing the Battery Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Figure 10 XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Figure 11 Wired Connection of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Figure 12 Wireless Connection of the X-ray Detector (Station/Client Mode) . . . . . . . . . . . . 29
Figure 13 Wireless Connection of the X-ray Detector (WAP Mode) . . . . . . . . . . . . . . . . . . . . 30
Figure 14 Workflow for Acquiring an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
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List of Tables
Table 1 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table 2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Table 3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Table 4 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 5 Overview of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Table 6 Environmental Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Table 7 X-ray Detector Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 8 Accessories and Replacement Parts for the X-ray Detector. . . . . . . . . . . . . . . . . . . 16
Table 9 Specification of the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Table 10 Overview of the XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Table 11 Specification of the XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions . . . . . . 42
Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity . . . . . . 43
Table 14 Recommended Separation Distance between Portable and Mobile
RF-Communication Equipment and the X-ray Detector . . . . . . . . . . . . . . . . . . . . . 44
Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity
(Portable Equipment). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
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1.0 Scope
This document describes design elements and respective interfaces for the XRpad2 4343 detector.
The XRpad2 4343 X-ray detector series contain specific models for which the main difference is
the scintillator. Applicable mechanical, electronic, and software interfaces are addressed. Varex
digital X-ray Flat Panel Detectors and their accessories are components designed to be integrated
into products by X-ray system manufacturers. Manufacturers are responsible for qualifying,
validating, and certifying their products for their intended uses and meeting all applicable
regulatory requirements.
Final application and intended use is determined by the X-ray system manufacturer and is based
on the completed X-ray system design. It is the responsibility of the X-ray system manufacturer
to confirm the safety, efficacy and compliance of the X-ray system for its intended use, inclusive
of the detector. The Digital Radiography Software referred to in this manual is medical imaging
software for radiography, which is typically supplied by the X-ray system manufacturer or
third-party provider and is not part of the XRpad2 4343 detector.
2.0 Detector Options
The XRpad2 4343 X-ray detector series contain specific models for which the main difference is
the scintillator. The detector types are listed below:
•XRpad2 4343 HWA
•XRpad2 4343 HWC
•XRpad2 4343 HWJ
•XRpad2 4343 HWK
•XRpad2 4343 HWN
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5.0 Audience
This document is for users of the X-ray detector and for X-ray system manufacturers and X-ray
system installers who are responsible for installing the X-ray detector into an X-ray system.
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6.0 Abbreviations
Table 1 includes a list of abbreviations used in this manual and a description of each
abbreviation.
Table 1 Abbreviations
Abbreviation Description
AED Automatic Exposure Detection
AP Access Point
CR Computed Radiography
DFS Dynamic Frequency Selection
DR Digital Radiography
ESS Extended Service Set
FoV Field of View
fps Frames per second
GigE Gigabit Ethernet
I/F Interface
IP Internet Protocol
IPU Interface and Power Unit
LAN Local Area Network
LBC Lithium Battery Charger
LBP Lithium Battery Pack
LED Light Emitting Diode
MDD Medical Device Directive
OEM Original Equipment Manufacturer
REF Radiated Electromagnetic Field
Rx Caution: Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner
SELV Separated or Safety Extra-Low Voltage
SF Screen Film
WAP Wireless Access Point
WEEE Waste Electrical and Electronic Equipment
Wi-Fi Wireless Fidelity
WLAN Wireless Local Area Network
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