Varex Imaging XRpad2 HWC-M Series User manual

XRpad2 HWC-M Digital X-ray
Detector User Manual
•USER MANUAL
•BEDIENUNGSANLEITUNG
•MANUAL DE USUARIO
•MANUALE UTENTE
•MANUAL DE L’UTILISATEUR
•Руководство пользователя

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XRpad2 HWC-M Detectors User Manual

XRpad2 HWC-M Digital X-ray
Detector User Manual

BEFORE YOU BEGIN
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Before You Begin XRpad2 HWC-M Detectors User Manual
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.
•Installation requires a qualified technician to install and integrate the detector into the X-ray
system.
•The X-ray detector is intended for use by trained and qualified Radiologists, X-ray
technicians, or radiological 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 safe and proper condition, only trained and qualified personnel 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 Imaging 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-ray 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 indications for use and intended purpose.
•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.
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.

FOR YOUR SAFETY
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XRpad2 HWC-M Detectors User Manual For Your Safety
For Your Safety
To avoid personal injury or product damage, read this manual and all accompanying
information 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
the X-ray 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.
Reminder
This is a reminder to follow established processes and procedures.
IMPORTANT This indicates statements by agencies or authorities that are published
as important regulations or requirements.

FOR YOUR SAFETY
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For Your Safety XRpad2 HWC-M Detectors User Manual
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 intended purpose
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 Use of the X-ray detector and its equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the
other equipment should be observed to verify that they are operating
normally.
WARNING Do not connect the X-ray detector or the XRpad Interface and Power
Unit 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 Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.

FOR YOUR SAFETY
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XRpad2 HWC-M Detectors User Manual For Your Safety
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 Imaging
accessories and replacement parts. Product certification and warranty
are rendered void if any 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 hospital (clinical)
network. Connection of the X-ray detector directly with the hospital
(clinical) network may disturb the IT environment and may influence
the effective data throughput. The imaging workstation and the
WLAN access point must comply with one of the following standards:
IEC 60601-1, IEC 61010-1, IEC 60950-1, or IEC 62368-1.
WARNING Connection of the X-ray detector to the hospital (clinical) 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 hospital (clinical) network could introduce new risks
and require additional analysis.
WARNING •In wired mode the X-ray detector shall only be used in professional
healthcare facility environment.
•In wireless mode the X-ray detector could be used in home
healthcare environment and professional healthcare facility
environment.
The system integrator shall consider the risks which may arise if the
X-ray detector is placed near to active HF SURGICAL EQUIPMENT
and the RF shielded room of an ME SYSTEM for magnetic resonance
imaging, where the intensity of EM DISTURBANCES is high.
WARNING Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the X-ray detector, including cables
specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
WARNING The X-ray detector is not designed to control X-ray dose. The system
integrator is responsible for controlling the X-ray radiation.

FOR YOUR SAFETY
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For Your Safety XRpad2 HWC-M Detectors User Manual
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 Manual and Instructions for 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 X-ray detector is used for the first time with
patients.

FOR YOUR SAFETY
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XRpad2 HWC-M Detectors User Manual For Your Safety
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 supply mains with protective earth.