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.
Before You Begin4336Wv4 X-ray Detector
Before You Begin
•To avoid personal injury or product damage, read the manual and all accompanying papers
•The X-ray detector is intended for use by qualified professional personnel who are trained
•Install the X-ray Detector horizontally on a flat, stable surface. It is required to use a bucky or
•The user is responsible for using and maintaining the detector according to prescribed
•X-ray imaging, processing, image acquisition, and data storage must be performed in
•In no event is the X-ray detector manufacturer liable for direct, indirect, or consequential
USER MANUAL
carefully before operating the PaxScan 4336Wv4 system.
and knowledgeable in the use of X-ray detectors, X-ray systems, and electrical equipment.
a wall-mount for vertical or tilted positions. The X-ray Detector may cause an injury if it falls
or is dropped.
installation, usage, maintenance, handling, and storage specifications. To keep the detector
and its accessories in safe and proper condition, only trained and qualified person(s) shall be
in charge of maintenance.
accordance with all applicable laws. The user is also responsible for compliance to laws
pertaining to the privacy of image data.
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 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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4336Wv4 X-ray Detector
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 use of
the detector may result in personal injury, death, or product damage. Keep this manual for
future reference.
Meaning of Alerts and Notes
USER MANUAL
DANGER
WARNING
Caution
Note
This indicates a potentially hazardous situation which, if ignored, will
result in severe personal injury, death, or substantial product damage.
This indicates a potentially hazardous situation which, if ignored, may
result in severe personal injury, death, or substantial product damage.
This indicates a potential hazardous situation which, if ignored, may
result in minor or moderate personal injury or damage to the product.
This emphasizes or supplements important information about the
main text.
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Before You Begin4336Wv4 X-ray Detector
Installation and Environment of Use
USER MANUAL
WARNING
WARNING
WARNING
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. All parts of the
detector are suitable for use within the patient environment. The proximity of
the detector to the patient is dependent upon the application by the system
integrator.
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.
Do not connect the X-ray detector 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.
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
WARNING
WARNING
WARNING
WARNING
Caution
The detector is not designed to control X-ray dose. The system
integrator is responsible for controlling the X-ray radiation.
The detector is not intended to be used as a primary barrier to X-rays.
The user is responsible for ensuring the safety of the operator,
bystanders, and the subjects being radiographed.
The detector is not suitable for use in the presence of or in
combination with active implanted devices such as defibrillators and
pacemakers. Doing so may prevent normal operation of these
peripherals.
For portable applications, the operator and end-user must take
precautions to protect themselves against dangerous X-ray exposure
when using the detector in the X-ray beam path.
Portable RF communications equipment should be used no closer than
30cm from the product or degradation of performance could result.
It is important that the detector is not directly connected to the
installed network. Connection of the detector with the installed
computer network may disturb the IT environment.
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4336Wv4 X-ray Detector
USER MANUAL
Caution
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 sulfurous 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.
The detector is an applied part (patient contact device) and the surface
shall not exceed 42°C internal temperature sensor data is provided in
the diagnostic data attached to each image. These temperature
measurements are well correlated with the panel external surface
temperature. It is advisable to monitor this diagnostic data as an
additional safety precaution, see document FP2032 - VSP Software
Interface.
Caution
Caution
Monitor the temperature of the X-ray detector, and allow the detector
to cool down when the temperature of the detector gets hot. The device
is not designed to supply heat to a patient. Ignoring this caution may
result in personal injury or damage to the product.
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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Before You Begin4336Wv4 X-ray Detector
Service Cable
Handling
USER MANUAL
WARNING
WARNING
WARNING
Caution
Disconnect the Service Cable by pulling on the connector and not the
cable itself. Ignoring this warning may cause substantial product
damage.
Do not modify the Service Cable 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 substantial product damage.
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.
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
Caution
Caution
Caution
Do not exceed the maximum uniform load weight of 150 kg
distributed across the surface of the X-ray detector.
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.
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.
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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4336Wv4 X-ray Detector
Battery
USER MANUAL
WARNING
WARNING
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.
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 battery pack to release toxic and harmful
substances causing injuries such as electric shock or burns, or cause a
fire, and will render the pack unusable.
Be sure to remove the battery before servicing, maintaining,
connecting, or disconnecting the accessories.
Do not touch the 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
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
Do not insert the battery into the 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.
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.
Use only charging devices approved by device manufacturer, and
never attempt to bypass or override their charging protection circuits.
Keep out of reach of children.
Remove the battery pack from the detector if the X-ray detector is not
likely to be used for some time.
Do not submerge the battery pack in water or other liquid.
Do not charge the battery pack near flammable materials.
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Before You Begin4336Wv4 X-ray Detector
WLAN
USER MANUAL
WARNING
WARNING
Caution
WARNING
WARNING
WARNING
Do not connect the battery pack to an electrical outlet directly, or to
any other electrical source not described in the manual.
Do not drop or hit the battery against hard objects since this may cause
damage to the battery pack 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.
There is a risk of explosion, personal injury, or damage to product if
the battery pack is replaced by non-OEM approved components.
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.
Do not route Ethernet cables near or with power cables, degradation of
performance could result.
Follow the laws and regulations for each country, and select the
regional code accordingly.
WARNING
WARNING
Caution
Caution
Caution
Do not use the detector in aircraft because there is a potential affect to
aviation systems.
Do not modify or alter the detector as this can violate the certification
of the Radio Law.
Use WLAN access point devices to get the best communication
performance.
The electromagnetic emission of the detector may influence
implantable medical devices like pacemakers. Check the information
for these devices.
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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4336Wv4 X-ray Detector
vTrigger Mode
USER MANUAL
WARNING
WARNING
WARNING
WARNING
The vTrigger 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
vTrigger operation with the complete X-ray setup in order to secure
the proper image acquisition in vTrigger mode.
The external sync mode is the default acquisition mode, and the
detector needs to switch into the vTrigger mode to use. An image may
only be acquired in vTrigger mode once the software has informed the
user that the system is ready.
The vTrigger on-time is limited and should be turned off directly after
acquiring the image. Staying longer in vTrigger mode will reduce the
battery duty cycle.
Do not apply any, handling, loading, mechanical shock, or electronic
noise to the detector while it is in vTrigger mode.
If a Problem Occurs
WARNING
WARNING
If any abnormal condition, such as smoke, fumes, or strange sounds, is
evident, remove the battery from the X-ray detector, 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.
When liquid has been spilled into or on any part of the X-ray detector
or battery, or when the X-ray detector, its component, or accessory is
dropped, 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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Before You Begin4336Wv4 X-ray Detector
Maintenance and Inspection
USER MANUAL
WARNING
WARNING
WARNING
Caution
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.
When the X-ray detector system is going to be cleaned, remove the
battery pack. 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.
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.
Follow the manufacturer’s recommendations for inspecting the X-ray
detector before use.
Table 16Europe - Restrictions for Use of 2.4GHZ Frequency in European Community . . 63
Table 17Europe - Declaration of Conformity in Languages of European Community . . . 66
This document describes design elements and respective interfaces for the PaxScan 4336Wv4
X-ray detector (Version 2). All applicable mechanical, electronic, and software interfaces are
described.
2.0Contraindication
There are no contraindication situations.
3.0Intended Use
Varex Imaging digital X-ray 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 safety, efficacy and compliance of the X-ray system intended for use, inclusive of the
detector. The Digital Radiography Software referred to in this manual is intended to be used for
development, testing, and maintenance purposes only.
USER MANUAL
Note
The system integrator is responsible for obtaining FDA clearance for medical
use.
4.0Audience
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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5.0Abbreviations
Table 1Abbreviations
AbbreviationsDescriptions
APIApplication Program Interface
a-siAmorphous Silicon
fpsFrames per second
hPaHectopascal
OEMOriginal Equipment Manufacturer
PREPPrepare
REQRequest
SDKSoftware Developer Kit
ViVAVarex Imaging and Viewing Application
VSPVarex Smart Panel
4336Wv4 X-ray Detector
USER MANUAL
vTriggerAutomatic Exposure Detection
WLANWireless Local Area Network
6.0Definition of Symbols
Table 2Explanation of Symbols
SymbolDescription
On (power connection)
Off (power disconnection)
Handle with Care
Direct Current
Authorized Representative in the European Community/European Union
IP54Protected from limited dust ingress.
Protected from water spray in any direction.
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4336Wv4 X-ray Detector
Table 2Explanation of Symbols (Continued)
SymbolDescription
Consult Instruction for Use
Load Weight Restriction
Do Not Discard with Domestic Waste
European Union Mark of Conformity to Applicable European Directives
Manufacturer
Non-ionizing radiation
USER MANUAL
Type B Applied Part
Underwriters Laboratory Safety Mark
China RoHS environmentally friendly for 10 years
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4336Wv4 X-ray Detector
7.0Standards and Regulations
The assembly of the X-ray Detector PaxScan 4336Wv4 is designed to be compliant with the
requirements detailed in Table 3 below. All regulatory certificates are valid only if the original
accessories are used. All regulatory certificates are rendered invalid if any modifications to the
Product are made, or any portion thereof, without obtaining the prior written authorization of
Varex Imaging.
.
Table 3Standards and Regulations
Detector StandardDescription
UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety 1st ed.
IEC 60601-1Medical Electrical Equipment Part 1: General Requirements for Safety 2nd ed.
EN/IEC 60601-1-2Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety
93/42/EECEuropean Union Medical Device Directive
2014/30/ECEuropean Union Electromagnetic Compatibility Directive
2014/53/EUEuropean Union Radio Equipment Directive
FCC Part 15 Subpart C
and Subpart E
EN 300 328Wideband Transmission Systems: 2.4GHz
EN 301 893Wideband Transmission Systems: 5GHz
EN 301 489-1Radio Equipment - Electromagnetic Compatibility
EN 301 489-17Broadband Data Transmission Systems
Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance.
Medical Electrical Equipment, Part 1 General Requirements for Basic Safety
and Essential Performance.
Medical Electrical Equipment, Part 1 General Requirements for Safety.
and Essential Performance Collateral Standard: Electromagnetic
Compatibility 4th ed.
Telecommunication - Intentional Radiators and Unlicensed Devices
MDD Class IIa
A Declaration of Conformity has been filed for this product and available upon request by contacting
Varex Imaging.
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4336Wv4 X-ray Detector
8.0Description of the PaxScan 4336Wv4
The PaxScan 4336Wv4 detector is a light-weight, wireless detector designed for medical and
veterinary use. The detector together with the Varex Smart Panel (VSP) software is designed for
integration into an X-ray system. The VSP performs all the interface functions with the detector;
such as control, image acquisition and calibration.
The PaxScan 4336Wv4 detector fits standard bucky trays and the wireless communication
enables easy migration between table, above the table, chest stand, and mobile cart physical
applications. The wireless access point is the interface between the detector and the imaging
system and may be mounted in an equipment enclosure, or it may also be wall or ceiling
mounted to maximize wireless signal strength. During operation, the detector is often draped or
bagged to ensure cleanliness and sterilization, and is manipulated such that the detector’s input
window is located near, but on the opposite side of the patient, from the X-ray source. An
additional cable is supplied with the detector to allow for set-up of the wireless interface and to
retrieve images from the detector in case of failed wireless transmission.
Figure 1 shows the configuration of the detector in the context of the typical overall imaging
system.
USER MANUAL
Figure 1Typical Detector Configuration
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4336Wv4 X-ray Detector
USER MANUAL
Note
Note
For proper operation, detector antennas and access point antennas should be
unobstructed.
Access point should not be installed next to power supply or generator
equipment.
Figure 2Imaging System Overview - without Router
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4336Wv4 X-ray Detector
USER MANUAL
Figure 3Imaging System Overview - with Router
Figure 4Imaging System Overview – Service Cable Connection
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4336Wv4 X-ray Detector
8.1Shipment Contents
Upon receipt, inspect the shipment and its contents against the Delivery Note enclosed with the
shipment for evidence of damage or missing components. Save all shipping containers in case a
return is warranted. If there is any discrepancy, See “After-sales Service for Varex Imaging Products” on page 56.
USER MANUAL
•Flat Panel Detector Assembly (includes a service cable for image recovery)
•Ethernet Service Cable, 6 ft., see Table 4 for a list of accessories.
Note
Note
There is one (1) cable connection for the detector which is the Service Cable.
This cable functions as an interface between the detector and the
workstation by providing a 100T Ethernet connection for set-up of the
wireless interface and as a last resort for retrieval of images from the
detector in case of wireless transmission failure.
The Service Cable is not for image acquisition.
8.1.1Supporting Files
This section describes the supporting files that are delivered with every detector.
•User Manual
•X-ray Detector Files (files specific to the detector in the shipment)
•Software Package
Note
Supporting files may be physically or electronically delivered. If no physical
files are present in the shipment, please contact your Varex representative
for instructions to download these files.
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4336Wv4 X-ray Detector
8.2Accessories
The PaxScan 4336Wv4 shall only be used with its approved Varex Imaging accessories and
replacement parts. Product certification and warranty are void if any modifications to the
product is made, or any instruction, warning, or caution is not followed.
Table 4Accessories
Description
Varex 1-bay Battery Charger
Varex 1-bay Battery Charger Power Supply, 65W, 19V (3.3 ft/1m)
1-bay Battery Charger Mounting Plate
Varex 3-bay Battery Charger
Varex 3-bay Battery Charger Power Supply 19V, 85W (3.3 ft/1m)
3-bay Battery Charger Mounting Plate
Varex Wireless Battery
Battery Overlay LED Display (Silver, Pd Silver, Black, Pure White, Var101 White)
USER MANUAL
Mains Hospital Grade 110V Cable (6.5 ft/2.0m)
Mains European Cable (8.2 ft/2.5m)
Mains Chinese Cable (8.2 ft/2.5)
Upon receipt, inspect the shipment and its contents against the Delivery Note enclosed with the
shipment for evidence of damage or missing components. Save all shipping containers in case a
return is warranted. If there is any discrepancy, See “After-sales Service for Varex Imaging Products” on page 56.
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8.3Detector Surfaces and Features
4336Wv4 X-ray Detector
USER MANUAL
Figure 5Detector Surfaces and Features
Table 5Detector Surfaces and Features
1Handles
2Battery Alignment Marker
3Battery and Battery Well
NumberDescription
4Battery Latch
5Patient Contact Surfaces
6Antenna
7Antenna
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4336Wv4 X-ray Detector
Table 5Detector Surfaces and Features (Continued)
NumberDescription
8LED Status Indicator
9Service Cable Connection
10Orientation Mark
8.4Detector Dimensions
USER MANUAL
Figure 6Detector Dimensions (measurements are in mm)
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8.5Detector Specifications
Table 6X-ray Detector Specifications
Sensor
DetectorAmorphous Silicon active TFT/PIN diode Technology
ScintillatorDirect-Deposit CSI or DRZ+
Pixel Matrix3072 (v) x 2476 (h)
Pixel Pitch139 µm
Active Area3062 (v) x 2466 (h) DRZ+, 3052 (v) x 2456 (h) CSI
Environments outside the specification reduce the lifetime and may irreparably damage the
Product.
Table 7Environmental Conditions
CategoryLimits
Storage & Transport (ambient)-20º C to +70º C
Storage Humidity Range (non-condensing)Detector: 10% to 90%
USER MANUAL
Normal Operation Temperature (measured at the center of
the back cover)
Operation Humidity (non-condensing)10% to 90%
Atmospheric Pressure Range700hPa to 1060hPa
Detector Altitude
10º C to 35º C
Operates at ≤ 3000m
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8.7Battery Installation and Removal
This section describes installing and removing the battery.
4336Wv4 X-ray Detector
8.7.1Battery Installation
1Insert battery at a slight angle so that the side with contacts sits over the adjoining contacts in
USER MANUAL
2Lay the battery down, one side will be slightly lifted.
3Press down on the lifted side of battery snapping it into place in the battery compartment.
4The detector is now ready for user.
Note
the battery compartment.
Note
For additional information about the Varex Imaging Wireless Battery and
Chargers, visit www.vareximaging.com.
When inserting the battery the angle of the battery should not be more than
20 degrees, inserting a battery at a larger angle could cause damage to the
battery contact pins.
Figure 7Representation of Battery Installation
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4336Wv4 X-ray Detector
8.7.2Battery Removal
1Slide the battery latch button to the right until there is an audible click and red is visible.
Doing this will cause one side of the battery to lift out of the battery compartment.
2Grab the lifted side of the battery and finish removing.
Figure 8Unlatch Battery
USER MANUAL
Figure 9Battery Removal
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4336Wv4 X-ray Detector
8.7.3Battery Charge Level
The battery charge level is indicated in the Radiographic Acquisition Progress window.
Figure 10 Battery Charge Level
USER MANUAL
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4336Wv4 X-ray Detector
8.8Power on Sequence
1Insert the battery into the charger to wake-up the battery from sleep mode (only applies to
batteries that are new).
2Place battery into detector making sure the battery latches into place. The detector will
automatically power on when battery is inserted.
USER MANUAL
Note
When a battery is inserted into the detector, the detector will boot into
Standby mode and the LED Status Indicator will blink at 1 second
intervals.
Figure 11 LED Status Indicator
Table 8LED Status Details
LED BehaviorStatus
Green and Yellow SolidBooting
Green Blinking (100000)Not associated
Green Blinking (1100)Service Cable Connected
Green Blinking (101010)Associated to the Access Point
Green SolidLinked to VSP
Yellow SolidPanel Error
Note
The blinking behavior occurs based on a 4Hz clock. Each digit for the
blinking pattern represents 1/4s. 0 - LED is off, 1 - LED on.
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4336Wv4 X-ray Detector
USER MANUAL
Note
WARNING
WARNING
WARNING
Note
The Service Cable does not provide power to the detector when tethered.
Before servicing, ensure that a fully charged battery is inserted.
Changes or modifications not expressly approved by the manufacturer
could void the user’s authority to operate the equipment.
Precautions should be taken to not open detector module. Depending
upon the type of scintillator used, opening the detector module may
expose the user to potentially toxic materials.
IP54
Detector able to withstand water spray from any direction.
Accessory or optional equipment connected to the analog and digital
interfaces must be certified to the respective IEC standards (i.e., IEC
60601-1 for medical equipment). Furthermore, all configurations shall
comply with the system standard IEC 60601-1-1. Anyone connecting
additional or optional equipment to the signal inputs or signal outputs as
part of a configuration for medical equipment is therefore responsible for
compliance with the equipment standard IEC 60601-1. If in doubt, consult
technical support personnel.
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4336Wv4 X-ray Detector
9.0Modes of Operation
The purpose of each mode is to configure the detector to achieve optimal performance during
specific imaging procedures. Modes are defined by a combination of factors, such as; cycle time,
integration time, field of view, noise, and pixel binning. Mode definitions are specified by a
configuration files. The configuration file is stored in the detector’s non-volatile memory. Each
mode requires a unique set of calibration files.
The PaxScan 4336Wv4 supports the Radiographic and vTrigger modes of operation see Table 9
for a typical mode example. The sensitivity of the detector is optimized to match the X-ray dose
used in each mode.
USER MANUAL
Note
Table 9Operational Mode Example
ModeRadiography - Full Resolution
Cycle Time5.6 Seconds
Pixel Binning1 x 1
Integration Time550ms
X-ray Window Time0.35 to 3.5 seconds
Image AreaFull Field
Frame Size2476 x 3072
Acquisition TypeAccumulation
The OEM should work with Varex technical support for configuration of the
mode(s) which best suit the customers intended application.
CharacteristicSpecification
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4336Wv4 X-ray Detector
9.1Radiography Mode
Within one exposure, multiple readouts are initiated by Prepare and followed by Trigger. Before
readouts, the detector has an integration period. The integration time is defined by the
configuration file for the current mode. In order to interface with the X-ray generator, two
events, exposure on and exposure off, are delivered to the workstation. The X-ray exposure
must happen between these two events.
One exposed frame is readout immediately after the integration window. The one or two
post-offset frame(s) are readout. The frames are transferred to the workstation as soon as
possible. When all the frames for the exposure are transferred to the workstation, a Transfer End
event is delivered to the workstation.
USER MANUAL
Figure 12 Exposure: Corrected Frames
Figure 13 Exposure: Raw Frames
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4336Wv4 X-ray Detector
9.2vTrigger Mode
The vTrigger mode gives the OEM the benefit of not requiring any hardware synchronization
with the generator. The vTrigger acquisition mode utilizes the detector’s hardware to sense
when X-rays are presented to the detector. Once X-rays have been detected, the detector
automatically begins a fixed integration time followed by the image readout.
9.3Operational States
The operational states of the detector can be categorized as follows:
•Radiography Acquisition: (Radiography-type)
•Offset Calibration: (OEM-initiated)
•Gain Calibration: (always-OEM initiated)
Each operating mode employs all types of calibration. For example, in radiography-type
acquisitions, the PaxScan 4336Wv4 will acquire one frame with its respective offset.
USER MANUAL
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4336Wv4 X-ray Detector
10.0System Software
The PaxScan 4336Wv4 detector deploys the Varex Smart Panel (VSP) architecture. Detector
software is embedded within the detector and is composed of two parts:
•Software necessary to capture, process, and correct X-ray images.
•The VSP COMM workstation libraries comprise the VSP SDK.
Because the main software is embedded within the detector, the only software required on the
workstation is a small set of DLLs that should be copied from the software package to the
workstation.
The VSP COMM libraries are copied to the workstation. Software interfacing to this detector will
make API calls to these SDK libraries to control the image acquisition process. These libraries
manage connections to the detector and the transfer of files from the detector to the workstation.
USER MANUAL
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4336Wv4 X-ray Detector
10.1X-ray Generator Interface Signals
Normally a set of hardware signals are used to interface between the detector and the X-ray
generator and hand switch. For example, PREP and REQ are two hand switch signals that are
typically used to indicate the user request for an X-ray exposure. Typically PREP (Prepare)
indicates the user’s input that X-ray exposure is imminent, while REQ (Request) indicates the
user’s input for immediate X-ray exposure. In response to the REQ signal, the detector will
indicate the proper time for the X-ray exposure with the EXP_OK (Exposure OK) signal.
To accomplish this task of passing hardware signals to-and-from the detector, the VSP provides
a software version of these signals in the API. For detectors, the workstation software will have
to provide the hardware interface to the X-ray Generator and hand switch and relay those
signals to the various API calls in the VSP library.
10.2VSP_COMM (SDK) Files
•libvsp.dll
•libvsp-zf.dll
•libwinpthread.dll
USER MANUAL
•vspcs.dll
•vsp.h
This set of files should be copied to the workstation. For customers working with C/C++, a vsp.h
header file is included along with the libraries. For customers working with C#, the vspcs.dll
provides the C# wrapper interface.
Note
Refer to FP2032_VarexSmartPanel_SoftwareInterfaceSpecification.pdf
which provides API documentation for the software.
10.2.1Bonjour Installation Files
•Bonjour.msi
•Bonjour64.msi
Bonjour is an optional installation and is required if you use the List()/vsp_list() API function
and ViVA software.
10.2.2Sample Code
•vsp-example.cs – C# sample code project
•vsp-example.c– C/C++sample code project
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10.2.3Utility Software
•vsp-file.exe
This file utility is used to transfer a configuration file to the detector.
4336Wv4 X-ray Detector
10.3Detector Calibration
Detector calibration files are stored inside the detector non-volatile memory. There are three
calibration files per mode: offset, gain, and defects. The calibration files are used for corrections
during image acquisition.
USER MANUAL
10.3.1Offset Calibration
Offset calibration compensates for fixed pattern pixel intensity variations in the image associated
with the dark current and electronic offsets. The Offset reference image is an average of a series
of frames acquired without X-ray and referred to as dark fields. Prior to acquiring images, an
offset calibration must be performed in each mode. This offset calibration is used for the preview
image.
Note
Note
For interfaces connection, synchronization and timing diagrams information
please reference the Software Interface Specification
After a calibration, ensure the new calibration files are used by closing and
re-opening the link to the detector.
•Offset calibration should not be performed during X-ray.
•The X-ray to digital conversion factor does not change because of calibration.
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10.3.2Offset Calibration Steps
1Choose the desired mode from the Mode Drop Down Menu.
Figure 14 Mode Drop Down Menu
2
Click the Offset Calibration Button or click Offset Calibration from the menu bar under
Acquisition.
USER MANUAL
Figure 15 Initiate Offset Calibration
3
A Calibration Setting window appears.
4Enter the number of frames desired and click OK.
Figure 16 Calibration Setting window
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5An Offset Calibration Progress window appears.
Figure 17 Offset Calibration Progress
4336Wv4 X-ray Detector
USER MANUAL
6
7Click Close.
Once all frames are acquired, the detector is updated with the averaged offset calibration
frame for the current mode. The updated message will show on the progress window and
calibration process is complete.
Figure 18 Finish Offset Calibration
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10.3.3Gain Calibration
To compensate for non-uniformities in the detector, a gain reference image (flat field) is used by
the Corrections module as required to correct all images. The flat field image must be captured
by the Varex Smart Panel (VSP) prior to acquiring images. The process of capturing the flat field
image is known as Gain Calibration.
USER MANUAL
Note
Gain calibration is based upon the linear response of the detector to dose. Normalization is
achieved by applying the flat field image acquired during the Gain calibration to all images
corrected by the VSP. Normalization will fail with pixels that are responding to dose in a
non-linear manner. Pixels responding to dose in a non-linear manner are usually caused by the
saturation of the detector, or a low signal-to-noise ratio.
Note
Flat field images acquired near or exceeding the saturation point will cause normalization
failures with all images acquired until a Gain calibration with the correct dose is performed.
Note
Every time a gain calibration is run, an offset calibration is required
beforehand; this will ensure that the detector is properly calibrated.
It is critical to acquire the flat field image within a range that is large enough
to be higher than the background noise created by the X-ray source and
readout electronics of the detector, but lower than the saturation point of the
detector.
It is recommended that flat field images be acquired with a median count of
approximately 13000 - 14000.
This range will ensure that Gain calibration will meet both the upper and lower dose
requirements under all modes of operation. Dose requirements are determined by the settings of
the generator X-ray source.
To reduce the effects of noise, the average of each pixel in the flat field image is calculated by
accumulating a number of frames into an internal memory buffer, then dividing the sum of each
pixel by the number of frames acquired.
Note
Using larger numbers of calibration frames to capture the flat field image
will result in more accurate calibration.
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4336Wv4 X-ray Detector
The number of calibration frames used during Gain and Offset calibrations can be adjusted
under the Mode Settings pull down menu.
The actual number of calibration frames used must be determined solely by the system
integrator depending upon their specific performance requirements.
The general procedure for Gain calibration for all modes is described in Table 10. Detailed
instructions on performing gain calibrations are covered in the ViVA Online help
documentation.
USER MANUAL
Table 10Gain Calibration - All Modes
Note
Gain calibration requires the production of X-rays and therefore certain
precautions must be taken by the human operator.
Note
We recommend accumulating 32 frames for gain calibration and 8 frames for
offset calibration for optimal image quality.
ActionResults
Power OnPower On the detector by inserting a battery. Once the detector is
powered on the detector is in low-power state. Wait 5 minutes prior to
Gain calibration.
Offset CalibrationSoftware performs a new Offset calibration referred to as dark field
acquisition.
Note: X-rays must not be used for this part of the calibration.
X-ray RadiationA uniform flat field with no obstructions in the path of the X-ray beam.
The radiation should ideally be at a level and technique representative
of the typical radiation dose for the
keeping in mind the general consideration outlined above.
RepeatThe above procedure must be repeated for each of the stored imaging
modes.
detector during typical procedures,
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4336Wv4 X-ray Detector
10.3.4Radiographic Mode Gain Calibration
Radiography Gain calibration requires an Offset calibration performed prior to collecting the
Flat Field image. Therefore, an Offset Calibration process must be run prior to the Gain
Calibration. X-ray illuminated frames are then offset-corrected and accumulated in the VSP. A
series of accumulated frames equals one radiographic X-ray exposure. Exposures are averaged
to obtain the Flat Field image used by the VSP. The number of exposures acquired can be
selected from the Settings window.
USER MANUAL
Note
ViVA provides the convenience of automatically running Offset Calibration
as part of the Gain Calibration process.
However, API driven Gain Calibrations do not automatically run Offset
Calibration. OEM Applications should be sure to run Offset Calibration
prior to Gain Calibration.
10.3.5Radiography Mode Gain Calibration Steps
1Choose the desired imaging mode from the Mode Drop Down Menu.
Figure 19 Mode Drop Down Menu
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4336Wv4 X-ray Detector
2Under the Acquisition menu, click Gain Calibration. This invokes hardware handshaking
for the dark field calibration.
Figure 20 Initiate Gain Calibration
USER MANUAL
3
WARNING
A Gain Calibration Progress window will appear. Use operator control to perform an
exposure.
In order to acquire an image with X-ray exposure in vTrigger mode,
Hardware Handshaking must be enabled, see Figure 28, or an image
without exposure will be returned.
Figure 21 Gain Calibration Progress window
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4336Wv4 X-ray Detector
4Once all X-ray frames have been acquired, the detector will update itself with the averaged
gain calibration for the current mode.
USER MANUAL
Figure 22 Gain Calibration Updating
5
After the detector has finished updating, an updated message and successfully finished
calibration message will appear. The calibration process is complete. Click Close.
Figure 23 Gain Calibration Complete
Note
Operator Control is user supplied equipment.
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4336Wv4 X-ray Detector
USER MANUAL
Note
Note
Note
Gain calibration should be performed at regular intervals, typically once
every six (6) months, or whenever the central beam of the X-ray source has
been moved relative to the detector.
Replacement of the X-ray tube will require a new gain calibration to be
performed.
If the detector is dropped, a new gain calibration is required.
Varex recommends accumulating 32 frames for gain calibration for optimal
image quality. However, the actual number of calibration frames used must
be determined solely by the system integrator depending upon their specific
performance requirements.
For additional assistance operating ViVA™, use the ViVA Online help
documentation.
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4336Wv4 X-ray Detector
10.4Link to the Detector
1Place a battery into the battery slot on the detector and latch into place. The detector LED will
begin to blink Green. See Table 8.
2To link to the detector, click the ViVA icon, to launch the application.
Figure 24 The ViVA Icon
3
The detector will link automatically in ViVA. When the detector is linked, the Mode Drop
Down Menu will become populated.
USER MANUAL
Figure 25 Detector Linked in ViVA
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10.5ViVA Mode Settings
This section describes the ways to view or change calibration and system settings that are
currently used in ViVA.
1Choose the desired imaging mode from the Mode Drop Down Menu.
Figure 26 Mode Drop Down Menu
2
USER MANUAL
4336Wv4 X-ray Detector
To enable or disable Hardware Handshaking, click Acquisition under the Menu Bar and
select or de-select Hardware Handshaking. ViVA will remember your preferences for future
launches.
Figure 27 Hardware Handshaking Not Selected
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4336Wv4 X-ray Detector
USER MANUAL
Figure 28 Hardware Handshaking Selected
3
To see System Settings, click Acquisition under the Menu Bar.
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4336Wv4 X-ray Detector
4Click on System Settings. A System Settings window will appear. Image and calibration
settings may be turned On or Off in this window.
USER MANUAL
Figure 29 Open System Settings
Figure 30 System Settings window
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4336Wv4 X-ray Detector
10.6Image Acquisition
After Offset and Gain Calibration have been performed the detector is ready to acquire images.
This section describes how to acquire images.
Table 11Types of Images Detector will Acquire in Radiographic and vTrigger Modes
Typ eImages transferred to Workstation
RawExposed Frame and Post-Offset Frame
CorrectedA single fully corrected frame
Offset CorrectedA single offset corrected frame, without gain and defect
correction
Gain CorrectedA single gain corrected frame, without defect correction
USER MANUAL
Note
When acquiring Correct, Offset Corrected, and Gain corrected images; if
preview is enabled and additional preview frame will be delivered to the
workstation prior to any additional frames.
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4336Wv4 X-ray Detector
10.6.1Radiography Mode
The Radiography mode provides superior single-shot, high-resolution images for diagnosis.
1Choose the desired imaging mode from the Mode Drop Down Menu.
Figure 31 Mode Drop Down Menu
USER MANUAL
2
Note
Make sure Hardware Handshaking is selected, see Figure 28.
Note
The OEM workstation should have the ability to employ the PREP and
Expose_OK signals.
In order to acquire an image with X-ray exposure in vTrigger mode,
Hardware Handshaking must be enabled, see Figure 28, or an image
without exposure will be returned.
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4336Wv4 X-ray Detector
3Click Acquire Image button or click Acquire Image in the Acquisition menu under the Menu
Bar to begin acquiring images.
Figure 32 Acquire Image Button
USER MANUAL
Figure 33 Acquire Image
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4336Wv4 X-ray Detector
4An Acquisition Progress window will appear. Click Start Acquisition and initiate X-ray
exposure.
Figure 34 Start Acquisition
USER MANUAL
5
Figure 35 Image Acquisition Progress
6
The Radiographic Acquisition Progress window will begin to show acquisition process with
a blue status bar. Once the image has appeared, another image may be taken or the window
may be closed by clicking Close.
The acquired image can be saved in the desired file format by clicking File/Save As.
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4336Wv4 X-ray Detector
10.6.2Radiographic Acquisition Settings
In the Radiographic Acquisition Progress window there are several settings that can be
changed.
1Click the Acquisition Type Drop Down Menu to switch between Software or Hardware
Acquisition.
USER MANUAL
Figure 36 Acquisition Type Drop Down Menu
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2Click on Settings, the Acquisition Settings Menu will appear.
Figure 37 Radiographic Acquisition Settings
3
USER MANUAL
4336Wv4 X-ray Detector
In the Acquisition Settings window; the type of corrected image, the number of loop
acquisitions, auto-save, and Debug Verbosity may be selected. Click OK.
The VSP Control Panel allows the user to control and modify settings of the detector function.
10.7.1Access the VSP Control Panel
To access the Control Panel:
1Open a browser and navigate to the IP Address of the detector, example:
http://192.168.2.31
2Authentication is required to make any modifications to the settings in Control Panel. The
first time any of the links are clicked on the left side of the control panel, you will be
prompted with a dialog box which allows you to log in.
USER MANUAL
Figure 39 VSP Control Panel Access Authentication
Note
Enter the default user and password:
3
The Authentication Required Dialog Box will look different in each browser,
but require the same User Name and Password.
•User Name: admin
•Password: password
4Click Log In.
Note
Once the detector is configured, the default password should be changed.
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4336Wv4 X-ray Detector
5The main VSP Control Panel screen displays links in the left pane. When a link is clicked the
content will show in the right pane.
Figure 40 VSP Control Panel
USER MANUAL
10.7.2Modify Settings
To modify the settings:
1Click Settings.
2The Settings content will load and any settings that are able to be modified.
3After inputting desired settings, click Update. The detector will reboot and the new settings
Figure 41 Modify VSP Control Panel Settings
will updated on the detector.
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4336Wv4 X-ray Detector
10.7.3Change Password
To change the password after logging in:
1Click Change Password.
2Enter a new Password.
3Once the new password is entered along with its matching confirmation, click Change to
confirm the new password.
4To clear the passwords entered in the forms, click Reset.
USER MANUAL
Figure 42 Change Password
Note
WARNING
Passwords must be at least 8 characters in length.
There is no back door available to the User or Varex. If the password is
mismanaged, it will result in the return of the detector for service.
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4336Wv4 X-ray Detector
10.7.4Firmware Update
To update the VSP Firmware:
1Click Update Firmware. This option is used to update all detector software
(embedded software, firmware, etc).
2Select the Varex provided firmware image by clicking Browse.
3After selecting the desired firmware, click Update Firmware to send the image to the VSP
and start the upgrade process.
USER MANUAL
Figure 43 Updating the Firmware
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4336Wv4 X-ray Detector
4During the update, another page will display showing the file upload was successful. At this
point the detector will apply the updated firmware.
Figure 44 Firmware Updated
USER MANUAL
WARNING
WARNING
Do not remove the Service Cable until the detector’s LED is blinking
Green.
A fully charged battery should be used during firmware update. Do not
remove the battery during firmware update.
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4336Wv4 X-ray Detector
11.0Maintenance
In principle, the detector assembly is maintenance-free, however; it is important that all
correction files are regularly updated and used for image processing. In some applications it is
advantageous to update the offset correction file directly before each image.
Although the a-Si detectors are resistant to X-rays they can exhibit degradation over time when
exposed to high X-ray dose environments. Sensitivity and uniformity may change depending on
the weekly exposure duration and X-ray dose. Therefore the pixel correction files should be
checked and compared regularly to determine changes in bad pixels and clusters.
11.1Cleaning and Disinfecting
The detector is likely to become contaminated during use. The specific material most likely to
become contaminated is the X-ray grade carbon fiber input window and housing.
USER MANUAL
11.1.1Chemicals for Cleaning and Disinfecting
All chemicals listed below are approved for use can be used for cleaning and disinfecting
detector surfaces. To achieve full cleaning and disinfecting results, perform the procedures in
Section 11.1.2 and Section 11.1.3 for each cleaning product.
A list of chemicals is presented below:
•CAVI-Wipes from Metrex
•Isopropyl Alcohol
•Mild Soap and Water
•Ethanol 70%
WARNING
When the detector system is going to be cleaned or disinfected, be sure
to remove the battery pack. Ignoring this warning may result in
explosion, fire, or electrical shock, which may result in severe personal
injury, death, or substantial product damage.
•70% aqueous solution
•Chlorine Bleach, 3% aqueous solution
•Quaternary Ammonium Components
•Steris Coverage Plus NPD
•1 part Coverage Plus NPD to 255 parts Water
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11.1.2Cleaning the X-ray Detector
To clean the X-ray detector:
1Remove the battery from the X-ray detector.
2Locate and read the cleaning instructions specified on the product label. Follow the product
instructions for cleaning.
USER MANUAL
Note
3Dispense wipe from container.
4Visually inspect the device. If contamination is present, use a wipe to remove the
contamination from the device surface. Use multiple wipes, as applicable, to remove the
visible contamination.
5Take care to remove contamination from seams, joints, and other difficult-to-reach areas.
6Dispose of each wipe used for cleaning.
7If visible residue from the cleaning product is evident after air-drying, remove the residue
with a general Isopropyl Alcohol wipe, and let air-dry.
If you are using a disinfectant other than those specified, we recommend
you consult a specialist for the procedure for disinfection.
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11.1.3Disinfecting the X-ray Detector
To disinfect the X-ray detector:
1Remove the battery from the X-ray detector.
2Locate and read the cleaning instructions specified on the product label. Follow the product
instructions for cleaning.
3Wipe the entire surface of the target areas of the system until they are visibly wet with the
4Take care to wet seams, joints, and other difficult-to-reach areas.
5Ensure that the surfaces remain visibly wet for the maximum necessary disinfection time
USER MANUAL
Note
If you are using a disinfectant other than those specified, we recommend
you consult a specialist for the procedure for disinfection.
chemical solution. Target areas include any surface that was cleaned and/or any other
surfaces potentially contaminated during system use.
specified on the product label.
aIf a disinfection time is not specified on a chemical label for the concentration used,
ensure that the surfaces remain visibly wet for a minimum of 10 minutes.
bUse additional fresh wipes as needed to ensure continuous wet contact time during the
specified disinfection period.
cLet air-dry.
dIf visible residue is evident after air-drying, remove the residue with a general Isopropyl
Alcohol wipe, and let air dry.
eDo not re-use wipes. Discard wipes and gloves into the correct waste container.
WARNING
Do not use flowing liquid or immersion on the detector, battery,
battery compartment, or battery charger.
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12.0Trouble-Shooting
Table 12Problems and Solutions
Problem Solution
Detector fails to link wirelessly1. Ensure that the detector is associated to the access point refer to
Table 8 for LED indicator behavior.
2. Remove the battery, re-insert the battery, and try to associate
with the access point again.
3. If the detector will still not link, power cycle the access point.
4. If the detector will still not link, check the connections and the
settings on the access point. Check SSID and password to ensure
they match.
5. If problem persists, consult the manufacturer or field service
technician for help.
USER MANUAL
Detector causes Electro-Magnetic
Interference
Acquired image is Non-linear or
the pixel are past the saturation
point of dose
Acquired image is completely dark 1. Remove the battery, re-insert the battery, re-establish the link
Acquired image is noisy1. Ensure that surrounding equipment is not interfering and
1. Reorient or relocate the receiving device.
2. Increase the separation between the equipment.
3. Consult the manufacturer or field service technician for help.
1. Remove the battery, re-insert the battery, re-establish the link.
2. Ensure that the tube dose is set to the correct settings.
3. Acquire another image at the recommended median count as
stated in Section 10.3.3.
4. If problem persists, consult the manufacturer or field service
technician for help.
and acquire another image.
2. If problem persists, consult the manufacturer or field service
technician for help.
re-position the detector further away from equipment.
2. Remove the battery, re-insert the battery, re-establish the link
and acquire another image.
3. If problem persists, consult the manufacturer or field service
technician for help.
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Table 12Problems and Solutions (Continued)
4336Wv4 X-ray Detector
Acquired image shows a white or a
black channel
Acquired images show defective
pixels
USER MANUAL
Acquired image does not respond
to exposure or the subject that is
being X-rayed does not show up in
the acquired images
1. Remove the battery, re-insert the battery, re-establish the link.
2. Ensure that the tube dose is set to the correct settings.
3. Acquire another image at the recommended median count as
stated in Section 10.3.3.
4. If problem persists, consult the manufacturer or field service
technician for help.
1. Remove the battery, re-insert the battery, re-establish the link.
2. Ensure that the tube dose is set to the correct settings.
3. Acquire another image at the recommended median count as
stated in Section 10.3.3.
4. If the problem persists, add the defective pixels to the defect
map and redo a gain calibration.
5. Acquire another image.
6. If problem persists, consult the manufacturer or field service
technician for help.
1. Remove the battery, re-insert the battery, re-establish the link.
2. Ensure that the tube dose is set to the correct settings and that
the detector is in the path of the X-ray beam.
3. Acquire another image at the recommended median count as
stated in Section 10.3.3.
4. If problem persists, consult the manufacturer or field service
technician for help.
Acquired image shows vertical or
horizontal lines
Residual X-ray image from
previous acquired image shows in
current acquired image
Out of virtual memory Close some of the windows that are currently open.
1. Remove the battery, re-insert the battery, re-establish the link.
2. Ensure that the tube dose is set to the correct settings.
3. Acquire another image at the recommended median count as
stated in Section 10.3.3.
4. If the problem persists, add the defects to the defect map and
redo a gain calibration.
5. Acquire another image.
6. If problem persists, consult the manufacturer or field service
technician for help.
Charge on the sensor pixels from an exposure beyond the
saturation point of the pixels may cause a residual image. It can be
erased by increasing time between exposures or taking multiple
images until the artifact fades away.
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Table 12Problems and Solutions (Continued)
ViVA software freezesRestart the computer and re-launch the ViVA software.
ViVA error message 1. Email the error log file generated to:
USER MANUAL
flatpanel.warranty@vareximaging.com
found at C:\users\{username}\AppData\Local\
crashdumps\viva.log
Detector dropped1. Remove battery from detector and inspect for damage.
2. If the battery does not appear damaged, place into battery
charger to see if battery charger reports an error.
3. Inspect the detector for any physical damage.
4. Insert a charged battery into the detector and see if it powers on.
Note: It is best to use a different battery than the one that was in
the detector when it was dropped.
5. Re-establish a link.
6. Acquire an image from the detector and inspect for regions of
missing data.
Note: If the detector has been dropped and is not returned to
Varex, a new gain calibration must be performed.
. This log file is normally
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12.1After-sales Service for Varex Imaging Products
For product returns, contact your distributor or device manufacturer for shipping and packaging
instructions. Do not return products to Varex Imaging for repair or service without advance
notification. Include all required papers in the shipment.
We request that you obtain an RMA number for in-warranty and out-of-warranty returns of
products.
To ship the battery pack, follow the local and regional requirements for proper packaging and
shipping of Lithium Batteries.
.
USER MANUAL
13.0Disposing of the X-ray Detector
Contact you supplier or distributor, and check the terms of conditions of the purchase contract.
This product should not be mixed with other commercial waste for disposal. Follow the local
radiation protection regulations.
The Varex Imaging product may be attached as part of a component to other manufacturers’
systems. These other manufacturers are directly responsible for the collection and processing of
their own waste products under the terms of the WEEE Directive. Contact these producers
directly before discarding any of their products.
WARNING
WARNING
High energy X-rays and gamma rays greater than 5.5 MeV and/or
neutrons may cause activation above regulatory limits for shipping.
Varex cannot accept any radioactive shipments for activation above the
local regulatory limits.
If the X-ray detector or accessories have been contaminated with
potentially harmful substances, they cannot be accepted without written
evidence of decontamination. See Section 11.1.2 and Section 11.1.3 for
procedure of decontamination.
WARNING
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Precautions should be taken to not open the detector module.
Depending upon the type of scintillator used, opening the detector
module may expose the user to potentially toxic materials.
4336Wv4 X-ray Detector
14.0Safety
This section describes electromagnetic safety information.
14.1Electromagnetic Interference
This equipment generates, uses and can radiate radio frequency (RF) energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to other devices or
may be affected by other equipment in the vicinity. If this equipment does cause harmful
interference to other devices or is affected by other equipment, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the measures listed in Section 12.0.
This equipment uses wireless LAN (WLAN) radios for transferring images. The WLAN power
levels and antenna configurations have been tested and certified compliant through specific
absorption rate (SAR) limits set by FCC/IC Canada (Less than 1.6W/kG) with separations as
small as 0 cm between the panel antennas and human tissue. While compliant, it is still
recommended to reduce exposure when possible by:
•Positioning subject to be X-rayed away from the antennas (this also helps reduce image
transfer time).
USER MANUAL
•Removing the detector panel promptly when X-ray exposure is complete.
The detector uses RF energy for its
internal function. Nearby electronic
equipment may be affected.
The detector uses RF energy for its
internal function. Nearby electronic
equipment may be affected.
The detector is suitable for use in all establishments other than domestic and those
directly connected to the low
voltage power supply network that
supplies buildings used for domestic purposes.
The detector is suitable for use in all establishments other than domestic and those
directly connected to the low
voltage power supply network that
supplies buildings used for domestic purposes.
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4336Wv4 X-ray Detector
14.1.2Electromagnetic Immunity
Table 14ESD, Transient/Burst, Surge, Voltage Variation, Magnetic Fields
USER MANUAL
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601-1-2
test level
± 8 kV
contact discharge
± 2, 4, 8, 15 kV
air discharge
±2 kV AC Mains
±2 kV I/O Lines
±0.5 kV, ±1 kV
Line to Line
±0.5 kV, ±1 kV, ±2 kV
Line to Ground
Voltage dips:
0 % UT
(100 % dip in UT)
for 0,5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270°, 315°
0 % UT
(100 % dip in UT)
for 1 cycle
at 0°
70 % UT
(30 % dip in UT)
for 25/30 cycles
at 0°
Voltage Interruptions:
0 % UT
(100 % dip in UT)
for 250/300 cycle
ComplianceElectromagnetic environment
± 8 kV
contact discharge
± 2, 4, 8, 15 kV
air discharge
N/A
Battery power
equipment not
connected to mains
N/A
Battery power
equipment not
connected to mains
N/A
Battery power
equipment not
connected to mains
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the detector
requires continued operation during power
mains interruptions, it is recommended
that the system be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m30 A/mMagnetic field should be that of a typical
location in a typical commercial or hospital
environment.
www.vareximaging.com59
14.1.3RF Immunity
d
3.5
V
1
-------
P=
d
3.5
E
1
-------
P=
d
7
E
1
------
P=
Table 15Conducted/Radiated RF
4336Wv4 X-ray Detector
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
USER MANUAL
IEC 60601-1-2
test level
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.7 GHz
ComplianceElectromagnetic environment
N/A
Battery power
equipment not
connected to mains
10 V/m
80 MHz to 2.7 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the detector
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
80 MHz to 800 MHz:
800 MHz to 2.5 GHz:
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
a
Note
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of equipment
marked with the following symbol:
Some degradation of video & increase in video noise
possible.
.
b
At 80 MHz and 800 MHz, the higher frequency range applies.
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4336Wv4 X-ray Detector
USER MANUAL
Note
Note
Note
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the detector is used exceeds
the applicable RF compliance level above, the detector should be observed to
verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the detector.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than [V
] V/m.
1
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4336Wv4 X-ray Detector
14.2Radio Frequency (RF) Compliance Information
This section describes RF Compliance information.
14.2.1FCC/IC Compliance
This device complies with Part 15 of the FCC Rules and RSS-Gen (RSS-210, etc.) of IC Rules. Its
operation is subject to the following two conditions:
•This device may not cause harmful interference.
•This device must accept any interference received, including interference that may cause
undesired operation.
Transmission Band Frequencies: 2.4GHz, 5.2GHz, and 5.8Ghz band ranges
USER MANUAL
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures noted below:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from the one the receiver is
Note
connected to.
This equipment has been tested and found to comply with the
limits for a Class A digital device, pursuant to part 15 of the
FCC Rules and Canadian ICES-003. These limits are designed
to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance
with the instruction manual, may cause harmful interference to
radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which
case the user will be required to correct the interference at his
own expense.
•Consult the dealer or an experienced radio/TV technician for help.
The user may find the following booklet prepared by the Federal Communications Commission
helpful: The Interference Handbook
This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402.
Stock No. 004-000-00345-4.
62www.vareximaging.com
4336Wv4 X-ray Detector
USER MANUAL
Note
Modifications not expressly approved by the manufacturer could void the
user's authority to operate the equipment under FCC rules.
Note
In the 5150 to 5250 MHz frequency range this transmitter is restricted to
indoor use only.
14.2.2Restrictions for 2.4GHz Use in Europe
Table 16Europe - Restrictions for Use of 2.4GHZ Frequency in European Community
LanguageStatement
België/
Belgique
For private usage outside buildings across public grounds over less than 300m no special
registration with IBPT/BIPT is required. Registration to IBPT/BIPT is required for
private usage outside buildings across public grounds over more than 300m. For
registration and license please contact IBPT/BIPT.
Voor privé-gebruik buiten gebouw over publieke groud over afstand kleiner dan 300m
geen registratie bij BIPT/IBPT nodig; voor gebruik over afstand groter dan 300m is wel
registratie bij BIPT/IBPT nodig. Voor registratie of licentie kunt u contact opnemen met
BIPT.
Dans le cas d’une utilisation privée, à l’extérieur d’un bâtiment, au-dessus d’un espace
public, aucun enregistrement n’est nécessaire pour une distance de moins de 300m. Pour
une distance supérieure à 300m un enregistrement auprès de I’IBPT est requise. Pour les
enregistrements et licences, veuillez contacter I’IBPT.
DeutschlandLicense required for outdoor installations. Check with reseller for procedure to follow
Anmeldung im Outdoor-Bereich notwendig, aber nicht genehmigungspflichtig.Bitte mit
Händler die Vorgehensweise abstimmen.
FranceRestricted frequency band: only channels 1 to 7 (2400 MHz and 2454 MHz respectively)
may be used outdoors in France.
Bande de fréquence restreinte : seuls les canaux 1- 7 (2400 et 2454 MHz respectivement)
doivent être utilisés endroits extérieur en France. Vous pouvez contacter I’Autorité de
Régulation des Télécommuniations (http://www.art-telecom.fr) pour la procédure à
suivre.
ItaliaLicense required for indoor use. Use with outdoor installations not allowed.
E’necessaria la concessione ministeriale anche per l’uso interno.
Verificare con i rivenditori la procedura da seguire.
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4336Wv4 X-ray Detector
Table 16Europe - Restrictions for Use of 2.4GHZ Frequency in European Community
NederlandLicense required for outdoor installations. Check with reseller for procedure to follow.
Licentie verplicht voor gebruik met buitenantennes. Neem contact op met verkoper voor
juiste procedure.
All EU
member
states and
EFTA
countries
Note: To remain in conformance with European spectrum usage laws for Wireless LAN operation, the
USER MANUAL
This device may only be used indoors in the frequency bands 5150 – 5250 MHz and
5250 – 5350 MHz.
above 2.4GHz channel limitations apply for outdoor usage. The user should use the wireless
LAN utility to check the current channel of operation. If operation is occurring outside of the
allowable frequencies for outdoor use, as listed above, the user must contact the applicable
national spectrum regulator to request a license for outdoor operation.
64www.vareximaging.com
4336Wv4 X-ray Detector
15.0Regulatory
This section includes the manufacturers’ declaration of standards and regulations for which the
detectors complies with.
15.1Industry Canada Notice
To prevent radio interference to the licensed service, this device is intended to be operated
indoors and away from windows to provide maximum shielding. Equipment (or its transmitting
antenna) that is installed outdoors is subject to licensing. The installer of this radio equipment
must ensure that the antenna is located or pointed such that it does not emit RF field in excess of
Health Canada limits for the general population; consult Safety Code 6, obtainable from Health
Canada's web site www.hc-sc.gc.ca/rpb.
Cet appareil numérique de la classe A est conforme à la norme NMB-003 du Canada Avis de
Conformité à la Réglementation d'Industrie Canada:
Pour empêcher toute interférence aux services faisant l'objet d'une licence, cet appareil doit être
utilisé à l'intérieur seulement et devrait être placé loin des fenêtres afin de fournir un écran de
blindage maximal. L'installateur du présent matériel radio doit s'assurer que l'antenne est située
ou pointée de manière à ce que cette dernière n'émette pas de champs radioélectriques
supérieurs aux limites specifées par Santé Canada pour le grand public; consulter le Code de
sécurité 6, disponible sur le site Web de Santé Canada, à l'adresse suivante:
www.hc-sc.gc.ca/rpb.
USER MANUAL
This equipment complies with FCC RF radiation and RSS 102 exposure limits set forth for an
uncontrolled environment. Body-worn operation and use near the head this device has been
tested and meets both FCC/ IC RF exposure guidelines when used within this product
guideline. The maximum SAR Value (Head) is 1.34W/kg. The maximum SAR Value (Body) is
1.37W/kg.
Cet équipement est conforme aux rayonnements RF de la FCC et RSS 102 limites d'exposition
définies pour un environnement non contrôlé. Opération Porté au corps et utiliser près de la tête
de ce dispositif a été testé et répond aux consignes d'exposition à la fois FCC / IC RF lorsqu'il est
utilisé dans ce produit directive. La valeur maximale SAR (Head) est 1.34W / kg. Le maximum
Valeur SAR (Body) est 1.37W/kg.
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4336Wv4 X-ray Detector
15.2Declaration of Conformity for European Union
Table 17Europe - Declaration of Conformity in Languages of European Community
LanguageStatement
Česky [Czech]Varex Imaging, Inc. tímto prohlašuje, že tento Radiolan je ve shodě se základními
požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES.
Dansk [Danish]Undertegnede Varex Imaging, Inc. erklærer herved, at følgende udstyr Radiolan
overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF.
Deutsch [German]Hiermit erklärt Varex Imaging, Inc., dass sich das Gerät Radiolan in
Übereinstimmung mit den grundlegenden Anforderungen und den übrigen
einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet.
Eesti [Estonian]Käesolevaga kinnitab Varex Imaging, Inc. seadme Radiolan vastavust direktiivi
1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele
asjakohastele sätetele.
EnglishHereby, Varex Imaging, declares that this Radiolan is in compliance with the
essential requirements and other relevant provisions of Directive 1999/5/EC.
USER MANUAL
Nederlands [Dutch]Hierbij verklaart Varex Imaging dat het toestel Radiolan in overeenstemming is
Español [Spanish]Por medio de la presente Varex Imaging. declara que el Radiolan cumple con los
requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de
la Directiva 1999/5/CE.
Ελληνική [Greek]ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Varex Imaging. ΔΗΛΩΝΕΙ ΟΤΙ Radiolan
ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ
ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ.
Français [French]Par la présente Varex Imaging déclare que l'appareil Radiolan est conforme aux
exigences essentielles et aux autres dispositions pertinentes de la directive
1999/5/CE.
Italiano [Italian]Con la presente Varex Imaging. dichiara che questo Radiolan è conforme ai
requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva
1999/5/CE.
Latviski [Latvian]Ar šo Varex Imaging deklarē, ka Radiolan atbilst Direktīvas 1999/5/EK
būtiskajām prasībām un citiem ar to saistītajiem noteikumiem.
Lietuvių
[Lithuanian]
Šiuo Varex Imaging deklaruoja, kad šis Radiolan atitinka esminius reikalavimus
ir kitas 1999/5/EB Direktyvos nuostatas.
met de essentiële eisen en de andere relevante bepalingen van richtlijn
1999/5/EG.
Malti [Maltese]Hawnhekk, Varex Imaging, jiddikjara li dan Radiolan jikkonforma mal-ħtiġijiet
essenzjali u ma provvedimenti oħrajn relevanti li hemm fid-Dirrettiva
1999/5/EC.
Magyar [Hungarian] Alulírott, Varex Imaging nyilatkozom, hogy a Radiolan megfelel a vonatkozó
alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.
66www.vareximaging.com
4336Wv4 X-ray Detector
Table 17Europe - Declaration of Conformity in Languages of European Community (Continued)
LanguageStatement
Polski [Polish]Niniejszym Varex Imaging oświadcza, że Radiolan jest zgodny z zasadniczymi
wymogami oraz pozostałymi stosownymi postanowieniami Dyrektywy
1999/5/EC.
USER MANUAL
Português
[Portuguese]
Slovensko
[Slovenian]
Slovensky [Slovak]Varex Imaging týmto vyhlasuje, že Radiolan spĺňa základné požiadavky a všetky
Suomi [Finnish]Varex Imaging vakuuttaa täten että Radiolan tyyppinen laite on direktiivin
Svenska [Swedish]Härmed intygar Varex Imaging att denna Radiolan står I överensstämmelse med
Varex Imaging declara que este Radiolan está conforme com os requisitos
essenciais e outras disposições da Directiva 1999/5/CE.
Varex Imaging izjavlja, da je ta Radiolan v skladu z bistvenimi zahtevami in
ostalimi relevantnimi določili direktive 1999/5/ES.
príslušné ustanovenia Smernice 1999/5/ES.
1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen
mukainen.
de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av
direktiv 1999/5/EG.
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4336Wv4 X-ray Detector
15.3International Compliance
This section describes international compliance.
15.3.1Argentina Compliance
Certificate Number: C-15871
15.3.2Mexico Compliance
The operation of this equipment is subject to the following two conditions: (1) it is possible that
this equipment or device does not cause harmful interference and (2) this equipment or device
must accept any interference, including interference that may cause undesired operation.
USER MANUAL
15.3.3Nigeria Compliance
15.3.4Philippines Compliance
15.3.5UAE Compliance
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4336Wv4 X-ray Detector
15.3.6Singapore Compliance
15.3.7Thailand Statement
This telecommunication equipment conforms to the requirements of the National Telecommunications Commission.
USER MANUAL
15.3.8Taiwan NCC Warning Statement
Based onlow-powerradio wavesradiatedmotor managementapproach:
•Article 12Typecertifiedlowpower radio frequencymotor, unlicensed, company,
firmor usershallnot alterthe frequency, increase the poweror change the
characteristicsofthe original designand function.
•Article XIVusinglow power radio frequencymotorsshall notaffectflight safetyand
interferencelawfulcommunication; whenthere isinterferenceby thediscovery
should be immediately suspended, andtoimprovewithoutinterferingmay continue
tobe used. Legal communicationsin the preceding paragraphrefers to thewireless
telecommunicationoperationsin accordance withtheprovisions of
telecommunications. Low-power radiocommunicationinterferencemotormust
endureradiationand Electronic Equipmentlegal orindustrial, scientificand medical
radio.
This module after getting certified in accordance with the provisions of the Flag tag in
the examination and certification body modules and require manufacturers to label
platform to platform.
The equipment belongs to the module certification, applicable to a variety of platforms.
Transmitter module includes: EW5270UM
Certificate #: CCAJ16LP0440T3
MPE (Maximum Permission Exposure) statement:
Electromagnetic exposure amount MPE standard value 1mW / cm2, send test products
measured value: 0.9846 mW / cm2.