4343W/4336W X-Ray Detectors
4343W/4336W X-Ray Detectors
4343W/4336W X-Ray Detectors
Before using the X-ray Detectors, 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 Begin 4343W/4336W X-ray Detectors
or is dropped.
• The User is responsible for using and maintaining the X-ray Detector according to prescribed
installation, usage, maintenance, handling, and storage specifications. To keep the X-ray
Detector and its accessories in safe and proper condition, only trained and qualified person(s)
shall be in charge of maintenance.
• X-ray imaging, 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 the X-ray Detector manufacturer 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.
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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 X-ray Detector may result in personal injury, death, or product damage. Keep this manual for
future reference.
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Before You Begin 4343W/4336W X-ray Detectors
WARNING The X-ray Detectors are 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 X-ray Detectors are suitable for use within the patient
environment. The proximity of the X-ray Detectors to the patient is
dependent upon the application by the system integrator.
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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 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.
WARNING The X-ray Detector is not designed to control X-ray dose. The system
integrator is responsible for controlling the X-ray radiation.
WARNING The X-ray 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.
WARNING For portable applications, the operator and end-user must take
precautions to protect themselves against dangerous X-ray exposure
when using the X-ray Detector in the X-ray beam path.
Caution The X-ray Detectors have an IP68 ingress protection rating. They are
completely protected against ingress of dust and has protection against
full water immersion for up to 60 minutes, at depths up 1m.
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Caution It is important that the X-ray Detector is not directly connected to the
installed network. Connection of the X-ray Detector with the installed
computer network may disturb the IT environment.
Caution Do not operate the X-ray Detector in a location with the following
conditions:
• Close to fluid or places where fluid is used
• Dusty environment
Caution The X-ray 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 X-ray Detector
external surface temperature. It is advisable to monitor this diagnostic
data as an additional safety precaution, see document 03236 FP2032 -
VSP Software Interface. Also, see Table 8.
Caution Monitor the temperature of the X-ray Detector and allow the X-ray
Detector to cool down when the temperature of the X-ray 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.
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Before You Begin 4343W/4336W X-ray Detectors
WARNING Disconnect the Cable by pulling on the connector and not the cable
itself. Ignoring this warning may cause substantial product damage.
WARNING Do not modify the Cable or subject the cable to external stress or
damage. Avoid placing anything heavy, including the X-ray Detector,
on the cable, stepping on the cable, pulling the cable, or subjecting the
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WARNING The Service Cable (4343W) does not support image acquisition. It
should only be used for the following:
• to retrieve an orphaned image from the X-ray Detector, when a wireless
connection is not available
• for service
Note Varex Imaging tests every X-ray Detector, using the tether cable, for
communication and link speed defects. Varex’s supplier of the tether
cable individually tests each cable before shipping.
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Handling
WARNING Do not use the Battery Latch as a handle. Ignoring this warning may
cause damage to the Battery Latch or increase the likelihood that the
X-ray Detector may be dropped causing substantial product damage.
Caution Place the X-ray Detector horizontally on a flat, stable surface. If the
X-ray Detector is placed vertically or in any tilted position, the X-ray
Detector must be securely placed in the bucky tray or securely
fastened to the X-ray Detector enclosure or support structure. Ignoring
this caution may result in personal injury or damage to the product.
Caution Do not 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
X-ray Detector. Further use under abnormal conditions may result in
severe personal injury, death, or substantial product damage.
Caution In the event that the X-ray Detector is dropped, a new Gain
Calibration must be performed.
Caution Do not expose the backside of the X-ray Detector with X-rays. Always
use the top side of the X-ray Detector for examinations.
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Before You Begin 4343W/4336W X-ray Detectors
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.
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WARNING The cells within the battery pack contain toxic substances. Do not
attempt to open the battery packs. Do not insert any object into the
battery pack or use any device to pry at the battery pack casing.
Attempting to open the battery pack casing will damage the casing,
which could cause the 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.
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 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.
WARNING Observe and follow all safety information in this manual and on the
warning label found on the battery pack. Ignoring a warning may
result in personal injury or damage to the product.
WARNING Remove the battery pack from the X-ray Detector if the X-ray Detector
is not likely to be used for some time.
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WARNING Do not connect the battery pack to an electrical outlet directly, or to
any other electrical source not described in the manual.
WARNING 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.
Caution The Varex provided accessory power supply for tether mode (4336W)
will not introduce noise. An aftermarket power supply may not be
used with the X-ray Detector.
WLAN
WARNING Do not route Ethernet cables near or with power cables, degradation of
performance could result.
WARNING Follow the laws and regulations for each country and select the
regional code accordingly.
WARNING Do not use the X-ray Detector in aircraft because there is a potential
affect to aviation systems.
WARNING Do not modify or alter the X-ray Detector as this can violate the
certification of the Radio Law.
Caution Use WLAN access point devices to get the best communication
performance. Please contact your Varex representative for a list of
approved wireless access points.
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Before You Begin 4343W/4336W X-ray Detectors
Network
WARNING Do not connect the X-ray Detector to the common IT network, but use a
point-to-point connection or tethered connection with the host
computer or dedicated WLAN access point. Ignoring this warning may
cause unauthorized access to this device.
WARNING Ensure that only authorized users have access to the X-ray Detector and
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WARNING The vTrigger mode requires a sufficient X-ray dose rate to the X-ray
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.
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If a Problem Occurs
WARNING 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 clean the liquid, see Section 12.1.2, and
operation may resume.
WARNING Turn off the power of the X-ray Detector, see Section 11.4, when the
inspections indicated in this manual are going to be performed.
Ignoring this warning may result in electric shock, which may result in
severe personal injury, death, or substantial product damage.
WARNING When the X-ray Detector system is going to be cleaned; remove the
battery pack, cables, and wait until the X-ray Detector powers off.
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.
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Table of Contents
1.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.0 Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.0 Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.0 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
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Table of Contents 4343W/4336W X-ray Detectors
12.0 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
12.1 Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
12.1.1 Material Compatible Chemicals for Cleaning and Disinfecting . . . . . . 60
12.1.2 Cleaning the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
12.1.3 Disinfecting the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
12.2 Field Replaceable Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
13.0 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
13.1 After-sales Service for Varex Imaging Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
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15.3.1 United States FCC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
16.0 Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
16.1 Industry Canada Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
16.2 Declaration of Conformity for European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
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Table of Contents 4343W/4336W X-ray Detectors
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List of Tables
Table 1 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table 2 Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table 3 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Table 4 Optional Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Table 5 Description of Detector Surfaces and Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Table 6 Description of Detector Surfaces and Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Table 7 X-ray Detector Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Table 8 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Table 9 Temperature Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Table 10 Operational Mode Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Table 11 Battery Hot-Swap Operation Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Table 12 LED Status Details add details about LED behavior for Tether cable connected. 34
Table 13 Gain Calibration Sequence in ViVA- All Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Table 14 Types of Corrections that can be applied during Acquisition. . . . . . . . . . . . . . . . . 49
Table 15 Problems and Solutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Table 16 Radiated/Conducted Emissions, Harmonics, Voltage, Fluctuations & Flicker . . 67
Table 17 ESD, Transient/Burst, Surge, Voltage Variation, Magnetic Fields . . . . . . . . . . . . . 68
Table 18 Test Specs for Enclosure Port Immunity to RF Wireless Communications Equip-
ment69
Table 19 Europe - Declaration of Conformity in Languages of European Community . . . 75
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List of Tables 4343W/4336W X-ray Detectors
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List of Figures
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List of Figures 4343W/4336W X-ray Detectors
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1.0 Scope
This document describes design elements and respective interfaces for the Varex Imaging
Wireless X-ray Detectors 4343W-G5 and 4336W-G5. All applicable mechanical, electronic, and
software interfaces are described.
2.0 Contraindication
There are no contraindication situations.
Note The X-ray Detector is designed to be integrated into a complete X-ray system
by a qualified system integrator. The system integrator is responsible for
obtaining FDA clearance for medical use.
4.0 Audience
This document is for users of the X-ray Detector and for X-ray system manufacturers and X-ray
system installers who are responsible for installing the X-ray Detector into an X-ray system.
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4343W/4336W X-ray Detectors
5.0 Abbreviations
Table 1 Abbreviations
Abbreviations Descriptions
AED Automatic Exposure Detection (see vTrigger)
API Application Program Interface
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Symbol Description
On (power connection)
Direct Current
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Table 2 Definition of Symbols (Continued)
Symbol Description
IP68 The X-ray Detectors have an IP68 ingress protection rating. It is completely
protected against ingress of dust and has protection against full water immer-
sion for up to 60 minutes, at depths up 1m.
Manufacturer
Non-ionizing radiation
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8.0 Description of the X-ray Detectors
The X-ray Detectors are lightweight and wireless designed for medical and veterinary use. The
X-ray Detector together with the Varex Smart Panel (software is designed for integration into an
X-ray system. The VSP is the interface between the X-ray Detector and the Client PC; such as
control, image acquisition and calibration.
The X-ray Detectors fit into standard bucky trays and the wireless communication enables easy
migration between table and other physical applications.
The wireless access point is the interface between the X-ray 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. A Service Cable is supplied with the 4343W to allow for
set-up of the wireless interface and to retrieve images from the X-ray Detector in case of failed
wireless transmission. A Tether Cable is provided with the 4336W to provide power and
allows operation of the X-ray Detector through a wired interface.
During operation, the X-ray Detector is often draped or bagged to ensure cleanliness and
sterilization. It is manipulated such that the X-ray Detector’s input window is located near, but
on the opposite side of the patient, from the X-ray source.
Figure 1 shows the configuration of the X-ray Detector in the context of the typical overall
imaging system.
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4343W/4336W X-ray Detectors
WARNING For proper operation, X-ray Detector antennas and access point antennas
should be unobstructed.
WARNING Access point should not be installed next to power supply or generator
equipment. Please contact your Varex representative for a list of
approved access points.
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Figure 4 Service Cable Connection (4343W only)
Note The Service Cable functions as an interface between the X-ray Detector and
the workstation by providing a 100Mbp/s Ethernet connection for set-up of
the wireless interface and as a last resort for retrieval of images from the
X-ray Detector in case of wireless transmission failure.
Note The Service Cable does not provide power to the X-ray Detector when
tethered. Before servicing, ensure that a fully charged battery is inserted.
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R EFERENCE M ANUAL 4343W/4336W X-ray Detectors
Note The Tether Cable functions as an interface between the X-ray Detector and
the workstation by providing a 1 GBp/s Ethernet connection for tether
communication, set-up of the wireless interface, and as a last resort for
retrieval of images from the X-ray Detector in case of wireless transmission
failure.
Note The Tether Cable provides 19V to the X-ray Detector which allows it to run
on tether power and charge the Battery.
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8.2 Accessories
The X-ray Detector 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 4 Optional Parts and Accessories
Description Length
Inductive Charger N/A
Inductive Charger Power Supply 5 ft/1.5m
Varex 1-bay Battery Charger N/A
Varex 1-bay Battery Charger Power Supply, 65W, 19V 3.3 ft/1m
1-bay Battery Charger Mounting Plate N/A
Varex 3-bay Battery Charger N/A
Varex 3-bay Battery Charger Power Supply 19V, 85W 3.3 ft/1m
3-bay Battery Charger Mounting Plate N/A
Varex Wireless Battery N/A
Battery Overlay LED Display (Silver, Pd Silver, Black, N/A
Pure White, Var101 White)
Mains Hospital Grade 110V Cable 6.5 ft/2.0m
Mains European Cable 8.2 ft/2.5m
Mains Chinese Cable 8.2 ft/2.5m
Service Cable 6 ft.
Tether Cable 6.5 ft.
Power Supply
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 Section 13.1
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4343W/4336W X-ray Detectors
Number Description
1 Handles
2 Battery Alignment Marker
3 Battery and Battery Well
4 Replaceable Battery Latch
5 Antennas
6 Inductive Charging Receiver
7 Patient Contact Surface
8 Service Cable Connection
9 LED Status Indicator
10 Top of X-ray Detector, interior electronics location
11 Orientation Mark, also indicates glass array coordinates (X=0, Y=0)
12 Orientation Mark
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Figure 7 4336W X-ray Detector Surfaces and Features
Number Description
1 Handles
2 Battery Alignment Marker
3 Battery and Battery Well
4 Replaceable Battery Latch
5 Inductive Charging Receiver
6 Antennas
7 Patient Contact Surface
8 Tether Cable Connection
9 LED Status Indicator
10 Top of X-ray Detector, interior electronics location
11 Orientation Mark, also indicates glass array coordinates (X=0, Y=0)
12 Orientation Mark
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8.4 X-ray Detector Dimensions
Measured in mm and [inches in brackets].
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8.5 X-ray Detector Specifications
Table 7 X-ray Detector Specifications
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Radio
Antenna 2 x IPEX connector for 2T2R 2 x IPEX connector for 2T2R
Frequencies • UNII - 1: 5150MHz - 5250MHz • UNII - 1: 5150MHz - 5250MHz
• UNII - 3: 5725MHz - 5850MHz • UNII - 3: 5725MHz - 5850MHz
Note: Subject to local regulations Note: Subject to local regulations
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Modulation • 802.11a: OFDM (BPSK, QPSK, 16- • 802.11a: OFDM (BPSK, QPSK, 16-
QAM, 64-QAM) QAM, 64-QAM)
• 802.11n: OFDM (BPSK, QPSK, 16- • 802.11n: OFDM (BPSK, QPSK, 16-
QAM, 64-QAM) QAM, 64-QAM)
• 802.11ac: OFDM (BPSK, QPSK, • 802.11ac: OFDM (BPSK, QPSK,
16-QAM, 64-QAM, 256-QAM) 16-QAM, 64-QAM, 256-QAM)
Transmit Power • 802.11a: 14.5 + 1dBm • 802.11a: 14.5 + 1dBm
WIFI_Chain 0
• 802.11n/ac • 802.11n/ac
20_5180MHz~5240MHz: 13.5 + 20_5180MHz~5240MHz: 13.5 +
1dBm 1dBm
• 802.11n/ac • 802.11n/ac
20_5745MHz~5825MHz: 13 + 20_5745MHz~5825MHz: 13 +
1dBm 1dBm
• 802.11n/ac 40_5190MHz: 11 + • 802.11n/ac 40_5190MHz: 11 +
1dBm 1dBm
• 802.11n/ac 40_5230MHz: 13.5 + • 802.11n/ac 40_5230MHz: 13.5 +
1dBm 1dBm
• 802.11n/ac • 802.11n/ac
40_5755MHz~5795MHz: 13 + 40_5755MHz~5795MHz: 13 +
1dBm 1dBm
• 802.11ac 80: 10.5 + 1dBm • 802.11ac 80: 10.5 + 1dBm
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Table 7 X-ray Detector Specifications (Continued)
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Category Limits
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8.7 Temperature Sensors
Table 9 Temperature Sensor Readings
Note The T1 (4343W) and T2 temperature sensors are used to monitor the
internal temperature of the glass. These are the only temperature sensors
that need to be monitored by the OEM, see Table 9.
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4343W/4336W X-ray Detectors
A configuration file will ship with the X-ray Detector. The file is loaded by Varex onto the X-ray
Detector and will contain 1 or more modes. The configuration file is stored in the X-ray
Detector’s non-volatile memory.
The purpose of each mode is to configure the X-ray Detector to achieve optimal performance
during specific imaging procedures. Each mode is a combination of settings, such as; cycle time,
rad or vTrigger, and integration time. The integration time or window exposure time is set
dynamically, see Section 11.9. Refer to document 03236 FP-2032 - Varex Smart Panel Software
Interface for more information on how to dynamically change the integration time.
The X-ray Detector supports Radiographic and vTrigger modes of operation, see Table 10 for a
typical mode example. The sensitivity of the X-ray Detector is optimized to match the X-ray dose
used in each mode.
Table 10 Operational Mode Example
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10.0 System Software
The X-ray Detector deploys the Varex Smart Panel (VSP) architecture. X-ray Detector software is
composed of two parts:
• Detector Software necessary to capture, process, and correct X-ray images (embedded in the
detector).
• The VSP SDK client libraries.
Because the main software is embedded within the X-ray Detector, the only software required on
the workstation is a small set of DLLs that are copied from the DVD to the workstation.
Software interacting with the X-ray Detector make API calls to these SDK libraries to control the
image acquisition process. These libraries manage connections to the X-ray Detector and the
transfer of files from the X-ray Detector to the workstation.
As noted, each acquisition is based on at least two frames being read from the detector. The first
readout is the exposed frame which is readout immediately after the integration window. The
second readout is the post-offset frame(s). If corrections are turned on, corrections will be
applied to the exposed frame and a single frame is transferred to the workstation as soon as
possible. When the frame is transferred to the workstation, a Transfer End event is sent to the
workstation indicating that the corrected frame has been delivered to the workstation (see 03236
FP-2032 - Varex Smart Panel Software Interface for more information on acquisition and use of
APIs).
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If corrections are not turned on (i.e. raw frames), multiple frames will be delivered to the
workstation (i.e. uncorrected exposed frame, and the post offset), see Figure 14.
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For modes that use vTrigger, only the Prepare command is used to arm the X-ray Detector, but
the Trigger command is not needed since the X-ray Detector is in a vTrigger mode that uses
automatic exposure detection. vTrigger modes will send the same notifications as those in the
radiographic mode (e.g. exposure on, exposure off, transfer end, etc.)
The sequences for integration and readout are the same as depicted in Figure 13 and Figure 14.
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10.3 X-ray Generator Interface Signals
Normally a set of hardware signals are used to interface between the X-ray 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 X-ray 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, VSP provides a
software version of these signals in the API. For X-ray Detectors, the workstation software must
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. Upon receiving PREP signal, the workstation software
should call the Prepare API function; upon receiving REQ signal, the workstation software
should call the Trigger API function. When exposure on event is received, the workstation soft-
ware should turn on the EXP_OK signal and when exposure off event is received, the workstation
software shall turn off the EXP_OK signal.
Discovery of the VSP detector is simplified also by using Zero-configuration (Zeroconf) net-
working for detection of the detector by the operating system.
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It should be noted that corrections files are not stored on the workstation. Corrections and
configuration files are stored on the X-ray Detector.
03236 FP2032_VarexSmartPanel_SoftwareInterfaceSpecification.pdf
which provides API documentation for the software.
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11.0 X-ray Detector Operation
This section describes the operation of the X-ray Detector.
Note New Batteries are shipped from Varex in shut-down mode. Before installing
into the X-ray Detector, the Battery must be inserted into the 1 or 3-bay
charger to remove it from shut-down mode.
Note For additional PDF information about the Varex Imaging Wireless Battery
and Chargers, visit www.vareximaging.com.
Note 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.
2 Lay the Battery down, with the side opposite of the battery contacts slightly lifted.
3 Press down on the lifted side of battery, the Battery will snap into place in the Battery
compartment.
4 The X-ray Detector is now ready for use.
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Figure 17 Battery Removal
WARNING Do not use the Battery Latch as a handle. Ignoring this warning may
cause damage to the Battery Latch or increase the likelihood that the
X-ray Detector may be dropped causing substantial product damage.
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4343W
3 minutes
4336W
WARNING If a fully charged battery is not re-inserted within the time window, the
X-ray Detector will power-OFF.
Note Acquisition and calibration features are not available while Hot-Swapping
a Battery.
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11.2 Optional Varex Provided Inductive Battery Charger
The Battery may be charged using the Varex provided Inductive Battery Charger while the X-ray
Detector is installed in the bucky tray.
WARNING Alignment between the Varex Inductive Battery Charger and the X-ray
Detector should be exact. Poor alignment or foreign objects may cause
overheating.
Caution The Varex Inductive Battery Charger and the X-ray Detector charging
location should be flush when charging.
Caution The Varex Inductive Battery Charger and Detector Support may not fit
all bucky trays. System Integrator should qualify bucky tray before
installing.
Caution Screw heads must be sub-flush to avoid damage caused to the X-ray
Detector when inserted into the bucky tray.
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Figure 19 Varex Inductive Battery Charger Dimensions (in mm) and Mounting Hole Locations
(4343W and 4336W)
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Figure 20 VHB Tape Placement Locations on Varex Inductive Battery Charger
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WARNING Third-party Inductive Battery Chargers must not be used in the bucky
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Note To support image acquisition while using the charger, the Varex
supplied Inductive Battery Charger must be used, see Section 11.2.
Figure 22 Third-party Inductive Battery Charger, 4343W, and 4336W X-ray Detector Alignment
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11.4 Power-on and Power-off Sequence
To Power-on:
1 Insert the Battery into the 1 or 3-bay charger to remove from shut-down mode (only applies
to Batteries that are new).
2 Place Battery into X-ray Detector making sure the Battery latches into place, see Section 11.1.1
and Section 11.1.2. The X-ray Detector will automatically power-on when battery is inserted.
Note When a Battery is inserted into the X-ray Detector, the LED Status Indicator
will turn orange as it boots. After booting, it connects to the configured
wireless router and is in Standby Mode, where the LED Status Indicator will
blink twice (2) per second. If the X-ray Detector does not connect to the
configured wireless router, it will blink slowly.
To Power-off:
1 Remove the battery from the X-ray Detector.
Note Removal of the Battery does not automatically power-off the X-ray Detector.
The X-ray Detector will stay powered-on for approximately 3 minutes or
until discharged after battery removal.
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Note The blinking behavior occurs based on a 4Hz clock. Each digit for the
blinking pattern represents 1/4s. 0 =LED OFF, 1 =LED ON, X = Previous
State.
Table 12 LED Status Details add details about LED behavior for Tether cable connected
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3 The X-ray Detector will link automatically in ViVA. When the X-ray Detector is linked, the
Mode Drop Down Menu will become populated.
Note Automatically linking to the X-ray Detector in ViVA will require that
Bonjour is installed.
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2 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. Hardware Handshaking is needed for gain calibration, see Section 11.10.4.
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Figure 29 Hardware Handshaking Selected
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11.9 Dynamic Integration Settings
Dynamic Integration allows the User to change the exposure time settings within ViVA.
1 Click the desired mode from the Mode Drop Down Menu.
2 Click Acquire Image Setup from the menu bar under Acquisition.
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4 Enter the integration time (exposure time) in the input box. Only values from 350 - 4000 ms
will be accepted.
Note This selection will be maintained until a new integration time is entered, a
different mode is selected, or the link has been closed.
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11.10 X-ray Detector Calibration
X-ray Detector calibration files are stored inside the detector’s non-volatile memory. There are
three calibration files per mode: offset, gain, and defects. Calibration files are used for
corrections during image acquisition.
Note After a calibration, ensure the new calibration files are used by closing and
re-opening the link to the X-ray Detector.
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2 Click the Offset Calibration Button or click Offset Calibration from the menu bar under
Acquisition.
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5 An Offset Calibration Progress window appears.
6 Once all frames are acquired, the X-ray 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.
7 Click Close.
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Note The gain calibration process will include automatically running an Offset
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Gain calibration is based upon the linear response of the X-ray Detector to dose. Normalization is
achieved by applying the flat field image acquired during the gain calibration to all images
corrected by the VSP. Gain calibration should be performed in the range where the detector is
linear.
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 It is recommended that flat field images be acquired with a median count of
approximately 11000 - 15000.
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 Gain calibration requires X-ray dose. Certain precautions must be taken by
the human operator.
The number of calibration frames used during Gain and Offset calibrations can be adjusted
under the Mode Settings pull down menu.
Note We recommend accumulating 32 frames for gain calibration and 8 frames for
offset calibration for optimal image quality.
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The actual number of calibration frames used is determined by the system integrator depending
upon their specific performance requirements.
Action Results
Power On Power 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 Calibration Software performs a new Offset calibration referred to as dark field
acquisition.
Note: X-rays must not be used for this part of the calibration.
Gain Calibration Multiple Gain frames taken. Software pauses at each frame so that the
operator can apply X-ray exposure.
Note: The exposure should ideally be at a level and technique
representative of the typical exposure dose for the detector
during procedures.
Repeat The above procedure must be repeated for each of the stored imaging
modes.
1 Choose the desired imaging mode from the Mode Drop Down Menu.
2 Under the Acquisition menu, click Gain Calibration. This invokes hardware handshaking
for the dark field calibration.
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3 A Gain Calibration Progress window will appear. When prompted (waiting for X-ray),
perform exposure.
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4 Once all X-ray frames have been accumulated, the calibration process will average the gain
calibration image for the current mode.
5 When complete, an updated message and successfully finished calibration message will
appear. The calibration process is complete. Click Close.
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11.11 Image Acquisition
Acquisition can be performed after Offset and gain calibration have been performed. This
section describes how to acquire images.
Before performing acquisition, settings should be checked to ensure that the desired corrections
are applied to acquired frames. Table 14 lists the types of corrections that can be applied.
Table 14 Types of Corrections that can be applied during Acquisition
Note When acquiring Corrected, 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.
1 To set the Correction type, click on Settings, the Acquisition Settings Menu will appear.
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2 In the Acquisition Settings window; the type of corrected image, the number of loop
acquisitions (if desired), Auto Save, and Debug Verbosity may be selected. Click OK.
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Note The OEM workstation should have the ability to employ the PREP and
Expose_OK signals. See Section 10.3 or Section VSPADU-UTILITY in 03236
FP2032_VarexSmartPanel_SoftwareInterfaceSpecification.PDF for an
example of controlling the X-ray Generator.
1 Choose the desired imaging mode from the Mode Drop Down Menu.
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3 Click Acquire Image button or click Acquire Image in the Acquisition menu under the Menu
Bar to begin acquiring images.
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4 An Acquisition Progress window will appear. Click Start Acquisition and initiate X-ray
exposure.
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5 The Radiographic Acquisition Progress window will begin to show acquisition process with
a blue status bar.
6 The acquired image can be saved in the desired file format by clicking File/Save As.
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11.11.2 Radiographic Acquisition Settings
In the Radiographic Acquisition Progress window the type of acquisition may be changed.
1 Click the Acquisition Type Drop Down Menu to switch between Software or Hardware
Acquisition (vTrigger).
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• Change Password
• Firmware Update
• View detector information
• View the Error Log
• Update Country Codes file
• Reset software to Factory Image
Note Control Panel screens will vary slightly for the type of detector. WiFi related
settings will only display for wireless detectors.
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Note The Authentication Required Dialog Box will look different in each browser,
but require the same User Name and Password.
Note Once the X-ray Detector is configured, the default password should be
changed.
5 The main VSP Control Panel screen displays links in the left pane. When a link is clicked the
content will show in the right pane.
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11.12.3 Change Password
To change the password after logging in:
1 Click Change Password.
2 Enter a new Password.
3 Once the new password is entered along with its matching confirmation, click Change to
confirm the new password.
4 To clear the passwords entered in the forms, click Reset.
WARNING There is no back door available to the User or Varex for password
recovery. If the password is mismanaged, it will result in the return of
the X-ray Detector for service.
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4 During the update, another page will display showing the file upload was successful. At this
point the X-ray Detector will apply the updated firmware.
WARNING A fully charged battery should be used during firmware update. Do not
remove the battery during firmware update.
WARNING Do not remove the Service Cable until the X-ray Detector’s LED is
blinking Green.
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12.0 Maintenance
In principle, the X-ray Detector assembly is maintenance-free, however; it is important that all
calibrations are regularly performed and used for image processing.
Although the a-Si X-ray 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
maps should be checked and updated regularly.
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12.1.2 Cleaning the X-ray Detector
To clean the X-ray Detector:
1 Remove the battery from the X-ray Detector.
2 Locate and read the cleaning instructions specified on the product label. Follow the product
instructions for cleaning.
Note If you are using a disinfectant other than those specified, we recommend
you consult a specialist for the procedure for disinfection.
Note If you are using a disinfectant other than those specified, we recommend
you consult a specialist for the procedure for disinfection.
3 Wipe the entire surface of the target areas of the system until they are visibly wet with the
chemical solution. Target areas include any surface that was cleaned and/or any other
surfaces potentially contaminated during system use.
4 Take care to wet seams, joints, and other difficult-to-reach areas.
5 Ensure that the surfaces remain visibly wet for the maximum necessary disinfection time
specified on the product label.
a If 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.
b Use additional fresh wipes as needed to ensure continuous wet contact time during the
specified disinfection period.
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c Let air-dry.
d If visible residue is evident after air-drying, remove the residue with a general Isopropyl
Alcohol wipe, and let air dry.
e Do not re-use wipes. Discard wipes and gloves into the correct waste container.
WARNING Do not use flowing liquid or immersion on the X-ray Detector, battery,
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13.0 Troubleshooting
This section describes suggestions for troubleshooting.
Table 15 Problems and Solutions
Problem Solution
Detector fails to link wirelessly 1. Ensure that the detector is associated to the access point, refer to
Table 12 for LED indicator behavior.
2. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
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, IP Address, and
password to ensure they match.
5. If problem persists, consult the manufacturer or field service
technician for help.
Detector causes Electro-Magnetic 1. Reorient or relocate the receiving device.
Interference
2. Increase the separation between the equipment.
3. Consult the manufacturer or field service technician for help.
Acquired image is Non-linear or 1. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
the pixel are past the saturation re-insert the battery, re-establish the link.
point of dose
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 11.10.3.
4. If problem persists, consult the manufacturer or field service
technician for help.
Acquired image is completely 1. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
dark re-insert the battery, re-establish the link and acquire another
image.
2. Check synchronization between the X-ray Detector and the
X-ray source.
3. If problem persists, consult the manufacturer or field service
technician for help.
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Acquired image is noisy 1. Ensure that surrounding equipment is not interfering and
re-position the detector further away from equipment.
2. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
re-insert the battery, re-establish the link and acquire another
image.
3. Move the X-ray Detector from any device that may introduce
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noise.
4. If problem persists, consult the manufacturer or field service
technician for help.
Acquired image shows a white or 1. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
a black channel 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 11.10.3.
4. If problem persists, consult the manufacturer or field service
technician for help.
Acquired images show defective 1. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
pixels 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 11.10.3.
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.
Acquired image does not respond 1. Let power-off (Section 11.4) or reboot the detector (Section 11.5),
to exposure or the subject that is re-insert the battery re-establish the link.
being X-rayed does not show up in
2. Ensure that the tube dose is set to the correct settings and that
the acquired images
the detector is in the path of the X-ray beam.
3. Acquire another image at the recommended median count as
stated in Section 11.10.3.
4. Ensure that the X-ray Detector is in the X-ray Beam path.
5. If problem persists, consult the manufacturer or field service
technician for help.
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Table 15 Problems and Solutions (Continued)
Acquired image shows vertical or 1. Let power-off (Section 11.4) or Reboot the detector (Section
horizontal lines 11.5), 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 11.10.3.
4. If the problem persists, add the defects to the defect map and
redo a gain calibration.
5. Acquire another image.
6. Move the X-ray Detector away from any device that may
introduce noise.
7. If problem persists, consult the manufacturer or field service
technician for help.
Residual X-ray image from previ- Charge on the sensor pixels from an exposure beyond the
ous acquired image shows in cur- saturation point of the pixels may cause a residual image. It can be
rent acquired image erased by increasing time between exposures or taking multiple
images until the artifact fades away.
Out of virtual memory Close some of the windows that are currently open.
ViVA software freezes Restart the computer and re-launch the ViVA software.
ViVA error message 1. Email the viva.log and vsp.log files (located where viva.exe is
found) generated to:
flatpanel.warranty@vareximaging.com. This log file is normally
found at C:\users\{username}\AppData\Local\
crashdumps\viva.log
Detector dropped 1. Power-off the detector (Section 11.4) 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.
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.
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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.
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We request that you obtain an RMA number for in-warranty and out-of-warranty returns of
products.
Contact: flatpanel.warranty@vareximaging.com
WARNING X-ray Detectors containing CsI scintillators have the potential to become
activated above regulatory limits for shipping if they have been exposed
to high energies 8.5 MeV or higher. Varex cannot accept any activated X-
ray Detectors that have been used in environments 8.5 MeV or higher
that exceed the local regulatory limits.
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 Precautions should be taken to not open the X-ray Detector. Depending
upon the type of scintillator used, opening the X-ray Detector may
expose the user to potentially toxic materials.
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15.0 Safety - Electromagnetic 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 13.0.
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).
• Removing the X-ray Detector promptly when X-ray exposure is complete.
The X-ray Detector does meet the IEC 60601 Safety definition for essential performance.
However, some degradation of the image acquired and displayed is acceptable (e.g. small
amount of noise, pixelation, video artifact, etc.) if the degradation would not affect the diagnosis
or treatment. Images acquired shall be normal when the immunity interference stops. May
require User intervention to clear an error message or continue operation.
IEC 60601-1-2
Emissions test Compliance Electromagnetic environment
test level
RF conducted Group 1, Class A, N/A The detector uses RF energy for its
emissions 150 kHz – 30 MHz internal function. Nearby electronic
Battery power equipment may be affected.
EN55011/CISPR11 equipment not
connected to mains
RF radiated Group 1, Class A, Group 1, Class A, The detector uses RF energy for its
emissions 30 MHz – 1 GHz 30 MHz – 1 GHz internal function. Nearby electronic
equipment may be affected.
EN55011/CISPR 11
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IEC 60601-1-2
Immunity test Compliance Electromagnetic environment
test level
Electrostatic ± 8 kV ± 8 kV Floors should be wood, concrete, or ceramic
discharge (ESD) contact discharge contact discharge tile. If floors are covered with synthetic
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Voltage dips, short Voltage dips: N/A Mains power quality should be that of a
interruptions and typical professional healthcare
0% UT Battery power
voltage variations environment. If the user of the detector
(100% dip in UT) equipment not
on power supply requires continued operation during power
for 0,5 cycle connected to mains
input lines mains interruptions, it is recommended
at 0°, 45°, 90°, 135°,
that the system be powered from an
IEC 61000-4-11 180°, 225°, 270°, 315°
uninterruptible power supply or a battery.
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
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Table 17 ESD, Transient/Burst, Surge, Voltage Variation, Magnetic Fields (Continued)
IEC 60601-1-2
Immunity test Compliance Electromagnetic environment
test level
Power frequency 30 A/m 30 A/m Magnetic field should be that of a typical
(50/60 Hz) location in a typical professional healthcare
magnetic field environment.
IEC 61000-4-8
Table 18 Test Specs for Enclosure Port Immunity to RF Wireless Communications Equipment
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Table 18 Test Specs for Enclosure Port Immunity to RF Wireless Communications Equipment
Note: If necessary to achieve the Immunity Test Level, the distance between the transmitting antenna and the
X-ray Detector may be reduced to 1m test distance is permitted by IEC 61000-4-3.
Note 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 X-ray Detector is used
exceeds the applicable RF compliance level above, the X-ray Detector should
be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the X-ray Detector.
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15.3 Radio Frequency (RF) Compliance Information
This section describes RF Compliance information.
This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter. This device meets all the other requirements specified in Part 15E, Section 15.407 of
the FCC Rules.
Note 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. 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 their own
expense.
FCC responsible: Varex Imaging Corporation, 1678 South Pioneer Road, Salt Lake City, Utah
84104, USA, Tel: + 801/972-5000, Website: www.vareximaging.com
FCC Caution: Any changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate this equipment.
These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest
SAR value reported under this standard during product certification for use when properly
worn on the body is 1.319 W/kg.
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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
connected to.
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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.
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.
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16.0 Regulatory
This section includes the manufacturers’ declaration of standards and regulations for which the
X-ray Detector complies with.
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
This device complies with ISED license-exempt RSS standard(s). Operation is subject to the
following two conditions:
• this device may not cause interference
• this device must accept any interference, including interference that may cause undesired
operation of the device.
Le présent appareil est conforme aux CNR d' ISED applicables aux appareils radio exempts de
licence. L'exploitation est autorisée aux deux conditions suivantes:
• l'appareil ne doit pas produire de brouillage
• l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre le fonctionnement.
English
1 The device for operation in the band 5150-5250 MHz is only for indoor use to reduce the
potential for harmful interference to co-channel mobile satellite systems;
2 The maximum antenna gain permitted for devices in the band 5725-5825 MHz shall comply
with the EIRP limits specified for point-to-point and non point-to-point operation as
appropriate.
3 The worst-case tilt angle(s) necessary to remain compliant with the e.i.r.p. elevation mask
requirement set forth in Section 6.2.2(3) shall be clearly indicated.
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Francés
1 Les dispositifs fonctionnant dans la bande 5150-5250 MHz sont réservés uniquement pour
une utilisation à l’intérieur afin de réduire les risques de brouillage préjudiciable aux
systèmes de satellites mobiles utilisant les mêmes canaux;
2 Le gain maximal d’antenne permis (pour les dispositifs utilisant la bande 5725-5825 MHz)
doit se conformer à la limite de e.i.r.p. spécifiée pour l’exploitation point à point et non point
à point, selon le cas.
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3 Les pires angles d’inclinaison nécessaires pour rester conforme à l’exigence de la p.i.r.e.
applicable au masque d’élévation, et énoncée à la section 6.2.2 3), doivent être clairement
indiqués.
Radiation Exposure Statement:
These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest
SAR value reported under this standard during product certification for use when properly
worn on the body is 1.319 W/kg.
Ces exigences établissent une limite SAR de 1,6 W / kg en moyenne sur un gramme de tissu. La
valeur SAR la plus élevée déclarée selon cette norme lors de la certification du produit à utiliser
lorsqu'il est correctement porté sur le corps est de 1.319 W / kg.
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16.2 Declaration of Conformity for European Union
Table 19 Europe - Declaration of Conformity in Languages of European Community
Language Statement
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.
English Hereby, Varex Imaging, declares that this Radiolan is in compliance with the
essential requirements and other relevant provisions of Directive 1999/5/EC.
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 Šiuo Varex Imaging deklaruoja, kad šis Radiolan atitinka esminius reikalavimus
[Lithuanian] ir kitas 1999/5/EB Direktyvos nuostatas.
Nederlands [Dutch] Hierbij verklaart Varex Imaging dat het toestel Radiolan in overeenstemming is
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.
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4343W/4336W X-ray Detectors
Language Statement
Polski [Polish] Niniejszym Varex Imaging oświadcza, że Radiolan jest zgodny z zasadniczymi
wymogami oraz pozostałymi stosownymi postanowieniami Dyrektywy
1999/5/EC.
Português Varex Imaging declara que este Radiolan está conforme com os requisitos
[Portuguese] essenciais e outras disposições da Directiva 1999/5/CE.
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Slovensky [Slovak] Varex Imaging týmto vyhlasuje, že Radiolan spĺňa základné požiadavky a všetky
príslušné ustanovenia Smernice 1999/5/ES.
Suomi [Finnish] Varex Imaging vakuuttaa täten että Radiolan tyyppinen laite on direktiivin
1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen
mukainen.
Svenska [Swedish] Härmed intygar Varex Imaging att denna Radiolan står I överensstämmelse med
de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av
direktiv 1999/5/EG.
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Index
A H
Abbreviations 2 Hot-Swap, Battery 28
Accessories 9 How To
Acquire Image 49 Access Control Panel 54
Alerts and Notes, Meaning of iii Acquire Image 49
Gain Calibration 45
B Link 34
Battery Offset Calibration 42
Charge Level 27 Power Off 33
Installation 25 Power On 33
Removal 25 Reboot 33
Battery Hot-Swap 28
I
C Image Acquisition
Calibration Procedures 41 Auto-Save 50
Calibration, Gain Corrected Image 50
Counts 44 Debug Verbosity 50
Definition 44 Loop 50
Frames 45 Imaging Mode 50
Frequency 48 Inductive Charger Screws 30
Steps 45 Inductive Charging 29
Calibration, Offset Install Battery 25
Definition 41 Intended Use 1
Steps 42 Ionizing Radiation, Protection Against ii
Change Password 57
Charging, Inductive 29 L
Cleaning and Disinfecting Latch, Battery 26
Chemicals to Use 60 LED Status 34
Detector 61 Load Support 15
Country Code 54 Log File 54
Log In 54
D
Detector M
Features 10 Maintenance 60
Intended Use 1 Meaning of Alerts and Notes iii
Detector Settings 54 Monitor Temperature Sensor 19
Modify 56
Disposal 66 N
DVD, Contents 21 Notes and Alerts, Meaning of iii
E O
Electromagnetic Interference 67 Offset Calibration 41
Optional Parts 9
F
Factory Restore 54 P
Features, Detector 10 Password 55
Firmware 54 Change 57
Firmware Update 58 Recovery 57
Requirements 57
G Power-off 33
Gain Calibration 44 Power-on 33
Gain Calibration Steps 45 Protection Against Ionizing Radiation ii
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R Files to Install 21
Reboot 33 Gain Calibration Progress Window 46
Reboot the Detector 33 Hardware Handshaking 36
Remove Battery 25 Image Acquisition 49
Launch 34
S Mode Drop Down Menu 42
Safety Note Offset Calibration Button 42
Battery viii Offset Calibration Progress window 43
Cyber Security x Radiographic Acquisition Progress Window 52
Handling vii Save Image 52
If a Problem Occurs xi System Settings Window 38
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T
Temperature Sensor 19
Trouble-Shooting 63
Turn off 33
Turn on 33
U
Update Country Code 54
Updates 54
User Name 55
V
Varex Smart Panel (VSP) 5
ViVA
Acquire Image Button 51
Acquisition Settings 49, 53
Acquisition Type Drop Down Menu 53
Calibration Settings Window 42
Change Imaging Mode 50
Configuration Settings 36
Error 65
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USA
Varex Imaging Corporation Arazy Group GmbH
1678 So. Pioneer Rd. Am Flughafen, The Squaire 12 ®
Salt Lake City, UT 84104 60549 Frankfurt am Main
United States Germany
+1 801 972 5000 Phone
+1 801 973 5023 Fax
www.vareximaging.com
142910 C
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