Canon CXDI-Pro User manual

DIGITAL RADIOGRAPHY
Instructions for Use
CXDI-Pro
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1. This product complies with local radio frequency regulations in the country or region
where you purchased the product. Note that it cannot be used in any other areas.
When using the product, follow the notes on radio frequency in this manual.
2. Only a radiologist or a doctor shall use the product.
3. The product shall be maintained in a safe and operable condition by maintenance
personnel.
4. Note that the entire radiography system, including the product, is required to comply
with IEC 60601-1. Therefore, please make sure that only ME equipment conforming to
IEC standards is connected to the product. Connected medical equipment, such as
X-ray generators, must comply with IEC 60601-1, and image-capture computers and
displays must comply with IEC 60601-1, IEC 60950-1, or IEC 62368-1. For further
details, consult your sales representatives or local Canon dealers.
5. Connection of a system that uses the product to a network could result risks to
patients, operators, or third parties. A dedicated individual who is assigned
responsibility for maintenance should assess these risks in advance. The responsible
person should also assess the risks when changes to the network (including changes
in the network configuration, addition or disconnection of items to the network, or
update or upgrade of equipment connected to the network) occur after connection.
6. For U.S.A.
Rx only-Caution:
Federal law restricts this device to sale by or on the order of a licensed practitioner.
• Request your sales representative or local Canon dealer to install the product.
To customers
Important information on usage and management of
the product
Note on installation
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To customers
3
• Disposal of this product in an unlawful manner may have a negative impact on human
health and on the environment. Therefore, when disposing of this product, be absolutely
certain to follow the procedure which conforms with the laws and regulations applicable
to your area.
Only for European Union and EEA (Norway, Iceland and Liechtenstein)
This symbol indicates that this product is not to be disposed of with your
household waste, according to the WEEE Directive (2012/19/EU) and national
legislation. This product should be handed over to a designated collection
point, e.g., on an authorized one-for-one basis when you buy a new similar
product or to an authorized collection site for recycling waste electrical and
electronic equipment (EEE). Improper handling of this type of waste could have
a possible negative impact on the environment and human health due to
potentially hazardous substances that are generally associated with EEE. At the
same time, your cooperation in the correct disposal of this product will
contribute to the effective usage of natural resources. For more information
about where you can drop off your waste equipment for recycling, please
contact your local city office, waste authority, approved WEEE scheme or
supplier where you purchased the product.
The information above, including information on batteries, is on our website in
the official languages of each EU country.
Please access https://global.canon/en/ifu/medcom/envfile/weee-battery-
eu.pdf.
Only for the United Kingdom
This symbol indicates that this product is not to be disposed of with your
household waste, according to the UK Waste Electrical and Electronic
Equipment Regulations. This product should be handed over to a designated
collection point, e.g., on an authorized one-for-one basis when you buy a new
similar product or to an authorized collection site for recycling waste electrical
and electronic equipment (EEE). Improper handling of this type of waste could
have a possible negative impact on the environment and human health due to
potentially hazardous substances that are generally associated with EEE. At the
same time, your cooperation in the correct disposal of this product will
contribute to the effective usage of natural resources. For more information
about where you can drop off your waste equipment for recycling, please
contact your local city office, waste authority, approved WEEE scheme or
supplier where you purchased the product.
The information above, including information on batteries, is on our website.
Please access https://global.canon/en/ifu/medcom/envfile/weee-battery-
uk.pdf.
Notes on disposal of the product
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1 Safety information
Follow these safeguards and properly use the equipment to prevent injury and damage to
any equipment/data.
1.1 Safety precautions
Operating/storage environment
• Do not use or store the equipment near flammable chemicals such as alcohol,
thinner, benzine, etc.
If chemicals are spilled or evaporate, it could result in fire or electric shock through
contact with electric parts inside the equipment. Also, some disinfectants are
flammable. Be sure to take care when using them.
• Do not connect the equipment with anything other than specified.
Doing so could result in fire or electric shock.
• Do not install or store the equipment in any of the locations listed below.
Doing so may result in failure or malfunction, equipment falling, or fire or injury.
– Close to facilities where water is used
– Where it will be exposed to direct sunlight
– Close to the air outlet of an air-conditioner or ventilation equipment
– Close to a heat source such as a heater
– Where the power supply is unstable
– On the floor
– In a dusty environment
– In a saline or sulfurous environment
– Where temperature or humidity is high
– Where there is freezing or condensation
– In areas prone to vibration
– On an incline or in an unstable area
• Be sure that the patient is in continuous contact with the surface of the detector
for less than 1 minute. Depending on the heat generated by the internal device,
the temperature of the detector’s surface may increase by up to 9°C. Avoid
prolonged contact with the surface of the detector in order to decrease physical
stress and the possibility of low-temperature burns due to contact with the
patient’s skin.
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1 Safety information
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• When using the detector, if you observe an abnormal rise in temperature above
the temperatures listed below, stop using it immediately and contact your sales
representative or local Canon dealers.
The maximum temperature of the detector: 44°C*.
* This is measured during Canon’s maximum load test when the ambient temperature is set to
35°C.
Power supply and cables
• Do not place heavy object such as medical equipment on cables and cords, or
do not pull, bend, bundle, or step on them to prevent their sheath from being
damaged, and do not alter them neither.
Doing so may damage the cords which could result in fire or electric shock.
• Do not turn ON the power when condensation has formed on the equipment.
Doing so could result in fire or electric shock.
• When using the equipment’s wiring cable or the PC Connection Cable, it
becomes weakly magnetized. When exposing patients with cardiac pacemakers
to X-rays, always make sure that the patients have no problems during exposure.
If a problem occurs, keep the equipment (wiring cable or PC Connection Cable) away
from the patients and consult your doctor.
• Always connect the three-core power cord plug to a grounded AC power outlet.
• To make it easy to disconnect the plug at any time, avoid putting any obstacles
near the outlet.
Otherwise, it may not be possible to disconnect the plug in an emergency.
• Because the equipment cable is long, take care that cables do not become
tangled during use. Also, be careful not to get your feet caught in the cable.
Otherwise, it may cause a failure of the equipment or the injury of the user due to
tripping over the cable.
• Do not charge a deteriorated battery.
Using a battery that has exceeded its product life may lead to overheating, fire, or
explosion.
• Do not charge the battery when the equipment is covered with an object (such
as a cloth).
Doing so may result in overheating or fire.
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Handling
• Do not place anything on top of the equipment.
The object may fall and cause an injury. Also, if metal objects such as needles or clips
fall into the equipment, or if liquid is spilled, it could result in fire or electric shock.
• Do not hit or drop the equipment. Handle the equipment carefully as it is
precision equipment.
The equipment may be damaged if it receives a strong jolt, which could result in fire or
electric shock if the equipment is used without being repaired.
• Attach the battery pack carefully.
• Make sure that the battery pack is correctly attached.
• Have the patient take a fixed posture and do not let the patient touch parts
unnecessarily.
If the patient touches connectors or switches, it could result in electric shock or
malfunction of the equipment.
• Always confirm that there is no problem with the CXDI system or the patient
during use. If a problem occurs, take appropriate measures, such as shutting
down the system.
• Do not splash the patient’s bodily fluids, medicines, water, etc. on any of the
equipment.
The detector provides dust proof and waterproof protection. However, note the following
precautions before using the equipment. The ingress of water may damage the
equipment and cause a fire or electric shock.
– Do not submerge the detector in water.
– If the detector gets wet, use a dry soft cloth to wipe it completely dry.
– Securely close and lock the battery cover. The dust proofing and waterproofing
performance may be compromised if the cover is not locked.
– Do not open or close the battery cover when there is dust on it or when the detector is
wet.
– Do not use the detector if water droplets or dust get inside the battery bay.
– If necessary, wrap the detector in a disposable cover to prevent the risk of infection.
– If the detector is bumped, dropped, or otherwise subjected to physical impact, the dust
proofing and waterproofing performance may deteriorate.
– The battery cover is a consumable item. If the battery cover is deformed or the packing is
damaged or cracked, replace the battery cover with a new one. Continuing to use the
battery cover in a deteriorated state may cause dust and water to penetrate the detector.
– Junctions between the wiring cable and Power Box and between the PC Connection
Cable and laptop computer are not resistant to dust or water.
• Turn OFF the power to each piece of equipment for safety when not being used.
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• Do not place excessive weight on the equipment.
Do not use the equipment in a manner that will subject it to local loads of 100 kg
or more.
If the load exceeds the limit, the inner device may be damaged.
• Do not touch the electrode terminals of the equipment and the battery pack.
• Be sure to use the equipment on a flat surface while using it in horizontal
position.
If the detector is set on a diagonal and pressure is applied to it, the inner device may be
damaged.
• Be sure to securely hold the equipment while using it in upright positions.
Otherwise, the equipment may fall over, resulting in injury to the user or patient, or may
flip over, resulting in damage to the inner device.
• Be sure to use only the dedicated battery pack for this product.
• When performing exposure in Non Generator Connection Mode, images may not
be acquired because the exposure conditions, such as X-ray exposure
conditions or target body positioning, are not effective.
• If battery liquid leaks and comes into contact with your skin or clothes,
immediately wash it off with tap water, etc.
The contact with the battery liquid may cause skin irritation.
• While preparing for examinations, be sure to confirm that the entered
information (patient name, ID number, date of birth, and sex) matches that of the
patient.
If the information is incorrect, the resulting patient mix-up and a misdiagnosis may
cause harm to the patient.
• Be sure to use the [Emergency] button only for an emergency examination.
If not heeded, the resulting patient mix-up and a misdiagnosis may cause harm to the
patient.
• In Non Generator Connection imaging, avoid doing the following actions to the
detector when [Ready] is displayed in the system status indicator.
Otherwise, the detector may acquire an image without exposure.
– Giving a strong shock and vibration.
– Using the detector in a location where static electricity is easily generated.
– Using the detector in a location where electromagnetic wave noise is strong.
• Instruct the patient not to move during the examination. If necessary, help the
patient to maintain the proper posture.
If the patient moves during the examination, it may fail to obtain the appropriate images.
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When a problem occurs
• Should any of the following occur, immediately turn OFF the power to each piece
of equipment, unplug the power cord from the AC outlet, and contact your sales
representative or local Canon dealer:
– When there is smoke, an odd smell or abnormal sound
– When liquid has been spilled into the equipment or a metal object has entered through an
opening
– When the equipment has been dropped and is damaged
Inspection, disinfection, and cleaning
• Do not use flammable solvents to clean the surface of the equipment.
When the equipment is going to be cleaned, be sure to turn OFF the power to each piece
of equipment, remove the battery pack, and unplug the power cord from the AC outlet.
Never use benzine, thinner or any other flammable solvents. Otherwise, it could result in
fire.
• Clean the plug of the power cord periodically by unplugging it from the AC outlet
and removing dust or dirt from the plug, its periphery and AC outlet with a dry
cloth.
If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around
the plug will attract moisture, and this could cause insulation failure that could result in a
fire.
• After every examination, wipe the patient contact surfaces of the detector using
a disinfectant such as disinfecting ethanol to prevent the risk of infection.
A blood infection or other causes may result in the onset of an infectious disease. For
details on how to disinfect, consult a specialist.
• Do not spray the detector directly with disinfectants or detergents.
• Always keep this product and other equipment clean and remove all dust and
dirt.
Dust and dirt may cause malfunctions of the equipment included in the radiography
system, such as this product and computers.
• When cleaning the battery pack, wipe it with a cloth slightly damped with water
or diluted neutral detergent.
The battery pack is not protected against liquids. When cleaning the battery pack, wipe it
carefully so as not to spill the detergents onto the electrodes.
• Dry the battery pack completely after cleaning, and attach it to the equipment.
• When cleaning any other parts than the sensor side of the detector, wipe them
carefully so as not to spill the detergents onto the battery pack attachment
portion (electrodes).
• Use water or diluted neutral detergent to clean the surface of the detector and
other equipment. Do not use paint thinner, benzine, or chlorinated solvents.
Doing so may damage the surface of the detector or other equipment.
• Dry the detector completely after disinfecting or cleaning it.
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1Safety information
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This product complies with local radio frequency regulations in the country or region where
you purchased the product. Note that it cannot be used in any areas other than the country
or region of its purchase.
In the frequency band used by this product, not only industrial, scientific and medical
equipment such as microwave ovens but also premises radio stations (license required)
and specified low-power radio stations (license not required) for mobile object
identification such as used in factory manufacturing lines, etc., and amateur radio stations
(license required) may be in operation. Use of this product may cause radio interference
with the above equipment and radio stations, so be sure to understand the following
precautions before use.
• Before using this product, make sure that there are no premises radio stations and
specified low-power radio stations for mobile object identification operating nearby.
• In the event that radio waves from this product cause harmful interference to premises
radio stations for mobile object identification, immediately stop using the product and
contact your sales representative or local Canon dealers.
• Also contact your sales representative or local Canon dealers if other problems occur,
such as harmful radio interference from this product to specified low-power radio
stations for mobile object identification or amateur radio stations.
• This product may be affected by radio interference from other devices that generate
radio waves (microwave ovens, Bluetooth devices, digital cordless phones, etc.). Keep
the product as far away from those devices as possible to avoid radio interference during
use.
• This product is suitable for use in hospital (professional healthcare facility) environments,
with the exception of environments near active HF SURGICAL EQUIPMENT or the RF
shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity
of ELECTROMAGNETIC DISTURBANCES is high.
•WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
• To maintain the optimum EMD performance, use only the designated cables.
•WARNING:
Use of equipment, transducers and cables other than those specified or provided by
Canon sales representative or local Canon dealer could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation.
•WARNING:
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the detector, including cables specified by Canon sales representative or local Canon
dealer. Otherwise, degradation of the performance of this equipment could result.
1.2 Notes on radio frequency
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1Safety information
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When using the equipment, take the following precautions. Otherwise, problems may
occur and the equipment may not function correctly.
Before use
• Sudden heating of the room in cold areas will cause condensation to form on the equipment.
In this case, wait until the condensation evaporates before performing an exposure. If the
equipment is used while condensation is formed on it, problems may occur. When an air-
conditioner is used, be sure to raise/lower the temperature gradually so that a difference in
temperature in the room and in the equipment does not occur, to prevent condensation.
During use
• Confirm that [Ready] appears in the system status indicator of the CXDI Control
Software and press the exposure switch.
• To reduce exposure to RF energy, keep hands and other body parts out of close contact
with the wireless aperture on the detector.
• Do not use the detector near devices generating a strong magnetic field. Doing so may
produce image noise or artifacts.
• Avoid unnecessary exposure for patients, especially for children. For details, be sure to
read the precautions on radiation protection in the manual for the connected X-ray
generator.
• When changing or adding exposure conditions in Non Generator Connection Mode, be
sure that Non Generator Connection Mode is fully operational before an exposure is
performed on a patient. Images may not be acquired or an artifact may appear
depending on the exposure conditions (X-ray dose, irradiation time, irradiation field or
target body positioning) even if an exposure is performed.
• Images and raw data stored on the recording medium in the equipment may become
unreadable due to operation errors, equipment failure, or other unexpected events, so
be sure to always store data on an external recording device (medium) or record it to film.
Disinfection and cleaning
• When disinfecting the patient contact surfaces of the detector, wipe them with a
disinfecting cloth moderately dampened with a disinfectant such as disinfecting ethanol.
• When cleaning the detector, wipe it with a cloth slightly dampened with water or diluted
neutral detergent.
Others
• Do not use this product in combination with other equipment such as defibrillators or
large electric motors as these may cause power-supply noise or power supply voltage
variations. Doing so may prevent normal operation of this product and other equipment.
• This product may malfunction due to electromagnetic waves caused by portable
personal telephones, transceivers, radio-controlled toys, etc. Be sure to avoid having
objects such as these, which affect this product, brought near the product.
• When the detector will not be used for some time, remove the battery pack. Otherwise,
overdischarge may occur, leading to a shorter battery life.
1.3 Notes for using the equipment
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2 Introduction
This device provides digital image capture for conventional film/screen radiographic examinations.
This device is intended to capture, for display, radiographic images of human anatomy, and to replace
radiographic film/screen systems in all general purpose diagnostic procedures.
This device is not intended for mammography applications.
The image is obtained as the result of imaging X-rays passed through the human body with an X-ray flat
panel detector and importing a digital signal output from the detector into the image processor.
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3 Operating procedures
1Switch on the image-capture computer on which the control
software is installed.
2Confirm that the control software starts and the initial
settings screen is displayed on the monitor.
1Attach a fully charged battery pack to the detector.
2Press the POWER switch of the detector to turn it on.
3Connect the detector to the image-capture computer.
1Enter the required items in the control software, such as the
Patient ID and target body part.
2After confirming that the ready indication is displayed on the
monitor of the image-capture computer, press the exposure
switch of the X-ray generator to irradiate the patient with X-
rays.
3.1 Preparations
System startup
Preparing to use the detector
3.2 Conducting examination
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3 Operating procedures
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1When the exposed image is displayed on the monitor of the
image-capture computer, confirm that the exposure conditions
and target body part are correct, that there is no blurring due to
patient movement, etc.
1Image processing such as LUT processing and frequency
processing takes place using the image processing parameters
set beforehand by the operator.
2Metadata such as Patient ID information is assigned to the image
data following image processing, and the image information is
transferred to the specified device.
1Shut down the image-capture computer.
2Press the POWER switch of the detector to turn it off.
3.3 Checking exposed images
3.4 Data processing
3.5 Ending use of the system
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3 Operating procedures
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Standard Synchronization Mode
*1 The indication of the Power LED lamps changes according to the remaining battery charge.
*2 Only after linkage from the detector
Standard Synchronization Mode
*1 On/Off status changes three times every 0.5 seconds
*2 Only 1 second
3.6 List of detector status indication
Detector status Status indicators
Power LED*1 READY LED
Power OFF Not illuminated Not illuminated
Power ON Illuminated Not illuminated
Linkage started Illuminated Flashing slowly in 4-
second cycles
(max. 8 seconds)*2
Linkage ended Illuminated Illuminated (2 sec.)
Switching to exposure ready status Illuminated Flashing
Exposure ready status Illuminated Illuminated
Detector selection status (Sleep) Illuminated Not illuminated
Error Flashing Flashing
3.7 List of lights / flashes / notification
beeps of the ready indicator
Link
(registration)
completed
During exposure ready status During exposure
Start time When the X-ray is
exposed
LED lamp The 2 LED
lamps flash*1.The 2 LED lamps light up weakly. The 2 LED lamps
light up*2.
Notification
sound
Three-tone
beep Single beep Two-tone beep
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3 Operating procedures
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To set the EIt value
Elt value can be set in the processing parameter edit screen of the CXDI Control Software.
Enter a value in the EIt text box referring to the current EI value.
• EI (Exposure Index)
EI is an approximative indicator of the dose that reaches the detector, as calculated per IEC
62494-1 standards from the captured images.
• EIt (Target Exposure Index)
EIt is the target EI level.
• DI (Deviation Index)
DI is a logarithmic index indicating the difference between the EI and EIt.
3.8 Image processing adjustment
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4 Troubleshooting
When you encounter problems described in this chapter or error messages in the CXDI Control Software
while using this product, search the table in this chapter for the problem or error message and try the
solutions.
If the problem persists, turn off the detector, consult your sales representative or local Canon dealer, and
inform them of the details of the problem, error codes or error messages.
Symptom
Cause/Error
messages in the CXDI
Control Software
Remedy
Power LED lamps flash
(1-second cycles) and
exposure is not
possible.
No battery power. Replace the battery pack with a fully-
charged one and retry an exposure.
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5 Maintenance
If any problem is found during the following inspections and cannot be resolved, please
contact your sales representative or local Canon dealer.
Cable
(1) Ensure that the cables are not damaged and the cable jackets are not torn so as to
expose the inside of the cables.
(2) Ensure that the power cord plugs are securely connected to both the equipment
AC inlet and the AC outlet.
(3) Ensure that there are no breaks or short-circuits in all pins of the detector connector
plugs.
(4) Ensure that there is no dust, dirt, or oil on the terminals of the wiring cable
connector.
Detector
(1) Ensure that there are no loose or missing screws.
(2) Ensure that there are no break or no deformation on the exterior of the detector.
(3) Ensure that there is no dust or foreign matter on the battery bay connector.
(4) Ensure that there are no breaks or short-circuits in the battery bay connector.
(5) Ensure that there is no dust, dirt, or oil on the terminals of the cable connector.
(6) Ensure that the battery cover is not damaged or bent.
(7) Ensure that there is nothing wrong with the rubber in the battery cover (foreign
objects, tears, cracks, etc.).
After turning on the power
Be sure to start the CXDI Control Software before performing the following inspection.
(1) Perform test exposure.
Ensure that captured images are displayed normally on the monitor.
Maintenance and inspection
Daily inspection
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5 Maintenance
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(1) Conduct a Performance Test.
(2) Regularly conduct a Self-diagnosis.
(1) Perform a Performance Test or Self-diagnosis using a phantom or resolution chart,
etc.
(2) Check the EI value captured.
(1) Perform calibration in the following circumstances.
- When exposure conditions have changed significantly
- When images appear strange in some way
- When the installation environment has changed significantly
Monthly inspection
Yearly inspection
Irregular inspection
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6 Specifications
6.1 Main specifications
Detector
Environmental requirements:
Operation
Temperature:
Humidity:
Atmospheric pressure:
5°C to 35°C
30% to 80% RH (without condensation)
613 to 1060 hPa
Storage (unpacked)
Temperature:
Humidity:
Atmospheric pressure:
5°C to 40°C
30% to 85% RH (without condensation)
613 to 1060 hPa
Transportation and storage (in packages at point of purchase)
Temperature:
Humidity:
Atmospheric pressure:
–30°C to 50°C
10% to 95% RH (without condensation)
613 to 1060 hPa
Applicable grid (Other devices): 40, 52* lp/cm (* recommended)
Reducing scattered radiation: Even when a grid is not attached to the detector, the
reduction in contrast caused by scattered radiation can
be improved by image processing. Adjust the power of
scatter correction by selecting the Effect check box to
enable this control on the Scatter Correction control
screen of the CXDI Control Software.
Rated power supply 22 to 24 V DC, 1.2 A
Dimensions and mass: Approx. 384 x 460 x 15.7 mm
Approx. 2.9 kg (incl. battery pack)
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6 Specifications
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Battery Pack LB-4A
Type: Lithium ion battery
Operation temperature range: 5°C to 35°C
Rated voltage: 11.1 V DC
Capacity: Typ. 1660 mAh / Min. 1600 mAh
Cycle life: Approx. 300 cycles (fully charged to fully discharged)
Dimensions and mass: Approx. 93 x 162 x 7 mm (excl. projecting parts)
Approx. 160 g
Image-capture computer
CPU: 4 or more cores (Intel Core i5 equivalent or better)
HDD: Minimum 50 GB free space
RAM: Minimum 6 GB
OS: Microsoft Windows 10 (X64)
Display: Equipped with touch functionality
XGA (1024 × 768) or above, SXGA (1280 × 1024) or
above
Communication interfaces:
Card reader
Connection interface USB
Readable cards JIS X6301 1998 compliant
Readable encoding JIS-II
Power supply USB bus power
Barcode reader
Connection interface USB
Compatible encodings Code39, Code93, Code128, JAN/EAN-8, JAN/EAN-13,
Industrial 2 of 5, Interleaved 2 of 5, Matrix 2 of 5, MSI,
NW-7, UPC-A, UPC-E, RSS, EAN-128, Plessey, PDF417
Power supply USB bus power
USB cable
Connector micro-B connector
Communication standard USB 2.0 compliant
Bluetooth adapter
Communication standard Bluetooth Low Energy compliant
Switching hub
Use a product that satisfies the following requirements.
• Supports 10/100/1000BASE-T Ethernet network interface.
• Equipped with Auto MDI/MDI-X functionality.
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