iRay Technology Luna1012X User manual

E
Luna1012X
Wireless Digital Flat Panel Detector
User Manual
Document Version: A1
Document ID: 166-201-02
Release Date: 4/2/2022

Luna1012X User Manual To Customers
i
To Customers
Thanks you for purchasing the Luna1012X (hereinafter referred to as Luna1012X) Digital Flat Panel Detector from
iRay Technology Co., Ltd. (hereinafter referred to as iRay).
This manual contains all the general information about the Luna1012X, which is intended to provide users with
instructions on installation, use and maintenance.
All information in this manual, including illustrations, is based on the equipment prototype. If your equipment does
not match with these contents, they will not apply to your equipment.
Information regarding the specifications, compositions, appearance, etc. of this product is subject to change without
prior notice.
Store this manual safely so that you can access it in the future.
Copyright
iRay Technology Co., Ltd. All rights reserved.
No part of this publication may be reproduced in any form or by any means without the written permission of iRay
Technology Co., Ltd.
Trademarks
The name and logo of iRay are registered trademarks of iRay Technology Co., Ltd.
Environmental Protection
This symbol indicates that this product cannot be disposed as domestic or commercial waste. Improper handling of this
type of waste may result in a negative impact on health and environment.
Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or
electronic waste items. Please contact your local authorities for information about practices established in your region.
If collection systems are not available, call iRay Customer Service for assistance.

Luna1012X User Manual To Customers
ii
For Your Safety
To avoid personal injury or product damage, be sure to read the user manual and all accompanying information
carefully and pay attention to all safety information before installing and using the detector.
The installation, debugging, addition, modification and maintenance of this product can only be carried out by
operators who has accepted the professional training offered by the iRay's customer service staff.
The equipment should be maintained in a safe and operable condition by maintenance personnel.
Only a physician or a legally certified operator is allowed to use this product.
Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1. For details,
consult our sales representative or local iRay dealer. For details, consult our sales representative or local iRay
dealer.
Disclaimer
iRay will not bear any responsibilities for any abnormality, equipment damage and personal injury caused due to
your failure to follow the warnings and operating instructions in this manual.
iRay shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by
purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product.
iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or
alterations to this product or failure to strictly comply with iRay’s operating and maintenance instructions.
iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other
than those dedicated as original iRay products.
During X-ray imaging, collecting, processing, reading and storing of image data, the user should comply with the
law of the countries where the product is used.
The users and operators of the product shall protect the privacy of image data.
The clinician is responsible for providing medical service and erroneous treatment due to misdiagnosis.
Warning Symbols
The warning symbols that appear in this user manual are classfied as follows for better comprehension of their
meanings. Make sure that you fully understand them and obey the instructions they contain.
!
WARNING
This indicates a potentially hazardous situation which, if ignored, may result in severe
personal injury, death, or substantial product damage.
!
CAUTION
This indicates a potentially hazardous situation which, if ignored, may result in minor
personal injury, death, or product damage.
PROHIBITED
This symbol is used to indicate a prohibited operation.

Luna1012X User Manual To Customers
iii
NOTE
This emphasizes or supplements important information about the main text.
REFERENCE
This symbol is used to indicate “please refer to accompanying documents attached to the CD
disk”.
Abbreviations
Abbreviations
Explanation
AC
Alternating Current
AED
Automatic Exposure Detection
AP
Access Point
DC
Direct Current
DR
Digital Radiography
EMC
Electro Magnetic Compatibility
FPD
Flat Panel Detector
FTP
File Transfer Protocol
HVG
High Voltage Generator
IP
Internet Protocol
IT
Information Technology
LAN
Local Area Network
LED
Light Emitting Diode
PC
Personal Computer
ROI
Range of Interest
RF
Radio Frequency
SAR
Specific Absorption Rate
SDK
Software Development Kit
SN
Serial Number
SSID
Service Set Identifier
TFT
Thin Film Transistor
UI
User Interface
WL
Window Level
WW
Window Width

Luna1012X User Manual Contents
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Contents
TO CUSTOMERS ............................................................................................................................... I
CONTENTS .....................................................................................................................................IV
1 SAFETY INFORMATION ................................................................................................................. 1
1.1 Product Symbols ........................................................................................................................................ 1
1.1.1 Symbols on the Package Box .........................................................................................................................1
1.1.2 Symbols on the Product Label ....................................................................................................................... 1
1.2 Safety Precautions ...................................................................................................................................... 3
1.2.1 Operation and Storage Environment ..............................................................................................................3
1.2.2 Equipment, Interface, Power Source, and Cables .......................................................................................... 4
1.2.3 Handling .........................................................................................................................................................5
1.2.4 Failure Handling............................................................................................................................................ 6
1.2.5 Battery ............................................................................................................................................................6
1.2.6 Maintenance and Inspection ...........................................................................................................................7
1.3 Notes for Using the Equipment .................................................................................................................. 7
2 REGULATORY INFORMATION ........................................................................................................9
2.1 Medical Equipment Classification ............................................................................................................. 9
2.2 Safety Standard Reference ......................................................................................................................... 9
2.3 Guidance and Manufacturer’s Declaration For EMC ................................................................................ 9
2.3.1 EMI Compliance Table .................................................................................................................................. 9
2.3.2 EMS Compliance Table ............................................................................................................................... 10
2.4 Battery Safety Standards .......................................................................................................................... 11
2.5 FCC Compliance ...................................................................................................................................... 11
2.6 Radio Frequency (RF) Energy ................................................................................................................. 12
3 PRODUCT INTRODUCTION .......................................................................................................... 13
3.1 Overview .................................................................................................................................................. 13
3.2 Scope of Application ................................................................................................................................ 13
3.3 Intended Use .............................................................................................................................................13
3.4 Essential Performance .............................................................................................................................. 14
3.5 Principle ................................................................................................................................................... 14
3.6 Basic Features ...........................................................................................................................................14
3.7 Packing List ..............................................................................................................................................14

Luna1012X User Manual Contents
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3.8 Component Description ............................................................................................................................15
3.8.1 Detector ........................................................................................................................................................15
3.8.2 Battery Pack ................................................................................................................................................. 17
3.8.3 Battery Charger ............................................................................................................................................ 17
3.8.4 Control Box..................................................................................................................................................18
3.8.5 Handle.......................................................................................................................................................... 19
3.8.6 Power Adapter ..............................................................................................................................................19
3.9 Product Installation ...................................................................................................................................20
3.9.1 Attaching Battery to Detector ...................................................................................................................... 20
3.9.2 Installing the Battery into Battery Charger .................................................................................................. 20
4 SOFTWARE INSTALLATION AND CONFIGURATION ....................................................................... 22
4.1 System Requirement .................................................................................................................................22
4.2 Software Installation .................................................................................................................................22
4.3 Wireless Connection .................................................................................................................................22
4.3.1 AP Mode ...................................................................................................................................................... 23
4.3.2 Client Mode ..................................................................................................................................................25
4.4 Introduction to iDetector Interface ........................................................................................................... 27
4.4.1 Home Page ................................................................................................................................................... 27
4.4.2 Acquire Page ................................................................................................................................................ 28
4.4.3 SDK Page .....................................................................................................................................................31
4.4.4 Detector Page ............................................................................................................................................... 31
4.4.5 Calibrate Page .............................................................................................................................................. 34
4.4.6 Local File Page .............................................................................................................................................38
4.4.7 Imaging Direction ........................................................................................................................................ 40
5 IT NETWORK .............................................................................................................................. 41
5.1 Purpose for IT Network ............................................................................................................................41
5.2 Required Characteristics ...........................................................................................................................41
5.3 Required Configuration ............................................................................................................................41
5.4 Technical Specifications ...........................................................................................................................41
5.5 Intended Information Flow .......................................................................................................................42
5.6 Hazardous Situations Resulting from Failure of the IT Network ............................................................ 42
5.7 Warning .................................................................................................................................................... 42
5.8 Changes to IT Network ............................................................................................................................ 42
6 WORKFLOW ............................................................................................................................... 43
6.1 Startup Procedure ..................................................................................................................................... 43

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6.2 Software Mode ......................................................................................................................................... 43
6.2.1 Block Diagram ............................................................................................................................................. 43
6.2.2 Workflow (PrepAcq) ....................................................................................................................................44
6.2.3 Workflow (Prep+Acq) ................................................................................................................................. 44
6.3 AED Mode............................................................................................................................................... 45
6.3.1 Inner Mode ...................................................................................................................................................45
6.3.2 Freesync Mode ............................................................................................................................................. 45
6.4 Calibration Template Generation ............................................................................................................. 46
6.4.1 Generating HWPreOffset Template .............................................................................................................46
6.4.2 Generating Gain Calibration Template ........................................................................................................ 46
6.4.3 Generating Defect Calibration Template ..................................................................................................... 48
6.5 Local Image Check ...................................................................................................................................50
6.6 Firmware Upgrade ....................................................................................................................................51
7 TECHNICAL SPECIFICATIONS ....................................................................................................... 53
7.1 Detector .................................................................................................................................................... 53
7.2 Battery ...................................................................................................................................................... 54
7.3 Battery Charger ........................................................................................................................................ 55
7.4 Environment Requirements ......................................................................................................................56
8 SERVICE INFORMATION .............................................................................................................. 57
8.1 Product Life ..............................................................................................................................................57
8.2 Regular Inspection and Maintenance ....................................................................................................... 57
8.2.1 Daily Inspection........................................................................................................................................... 57
8.2.2 Monthly and Yearly Inspection ....................................................................................................................58
8.3 Troubleshooting ....................................................................................................................................... 58
8.4 Customer Service ..................................................................................................................................... 59
8.5 Manufacturer Information ........................................................................................................................ 59

Luna1012X User Manual Safety Information
1
Copyright © iRay Technology Co., Ltd.
1 Safety Information
1.1 Product Symbols
1.1.1 Symbols on the Package Box
Symbol
Explanation
Symbol
Explanation
This symbol is used to indicate
“Keep the equipment up right”.
This symbol is used to indicate
“Fragile, handle with care”.
This symbol is used to indicate that
a medical device that needs to be
protected from moisture.
This symbol is used to indicate the
maximum number of stacks up to N
layers (for details, refer to the package
box).
This symbol is used to indicate that
the temperature range to which the
medical device can be safely
exposed.
This symbol is used to indicate that the
humidity range to which the medical
device can be safely exposed.
This symbol is used to indicate
“Keep away from direct sunlight”.
1.1.2 Symbols on the Product Label
The label in the figure below is only an example and does not represent the actual label. Please refer to the label on the
detector host.

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Copyright © iRay Technology Co., Ltd.
Symbol
Explanation
This symbol is used to identify the manufacture series number which is made of 19 digits as
shown below:
A1A2A3A4B1 B2C1C2L M1M2D1D2Y1Y2X1X2X3X4
Production Series No.
Production Date
Production Site
Production Version No.
Derivative Type
Production Type
Symbol
Explanation
Symbol
Explanation
This symbol indicates the name and
address of manufacturer.
!
Caution: please refer to the
instructions in the user manual.
This symbol represents reference to
the user manual for general
information.
This symbol is used to represent
nonionizing electromagnetic radiation.
This product is not to be disposed
of with your residential or
commercial waste.
20XX-XX-XX
This symbol is used to indicate the
expiration date.

Luna1012X User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
Symbol
Explanation
Symbol
Explanation
This symbol is used to indicate
operational temperature limits.
This symbol is used to indicate the
protection classification.
Device is for prescription use only
This symbol represents the application
part of type B, indicating that the
product has a patient contact part.
1.2 Safety Precautions
1.2.1 Operation and Storage Environment
!
WARNING
Do not operate or store the equipment in or around flammable or corrosive gases,
gas mixtures, liquids, chemicals, or other substances.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
!
CAUTION
Do not operate the detector in a location with the following conditions. Ignoring this
warning may result in equipment failure, fire, or personal injury.
Close to fluid or places where fluid is used
Where is 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
In a dusty environment
In a saline or sulfurous environment
Where temperature or humidity is high
Where there is freezing or condensation
In an area prone to vibration
On an incline or in an unstable area
Non-medical equipment, such as battery chargers, wireless routers, and infrared
devices, should not be used near patients.
All patients using active implantable medical devices should stay away from this
product.
Do not turn on the power switch when there is condensation on the detector or any
of its components or accessories.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.

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1.2.2 Equipment, Interface, Power Source, and Cables
!
WARNING
Be sure to connect non-product components to the equipment according to the label
and user manual.
Do not connect the detector to any component or accessory other than the
manufacturer’s specified ones. Do not use any power source other than the one
provided with the equipment.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
Be sure to turn OFF the power of the detector, including turning off the power
supply or removing the battery (if applicable) before connecting or disconnecting the
cables or accessories.
Do not touch the power supply, battery pack, detector, cable, connector, or any
other components with wet hands.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
To avoid the risk of electric shock, this equipment must be connected to a power
supply with protective earth.
Use only dedicated cables for the device. Do not use any other cables.
!
CAUTION
Observe and follow all safety information in this manual and on the warning labels
on the battery (if applicable).
Ignoring warnings could result in personal injury or product damage.
Do not modify the cables or subject the cable to external stress or damage. Avoid
placing anything heavy, including the detector, on the cable, stepping on the cable,
pulling the cable, or subjecting the cable to excessive bending or bundling.
Ignoring this warning may result in cable failure, which may result in personal injury, death,
or product damage.
Do not place excessive heavy objects on the equipment.
Otherwise, the internal sensor may be damaged and the equipment may not work normally to
acquire images.
Do not exceed the maximum uniform load weight of 300 kg distributed across the
surface of the X-ray detector.
Do not exceed the maximum load weight of 150 kg distributed on an area of 40 mm
in a diameter of the X-ray detector surface.
Do not hit or drop the equipment.
The equipment may be damaged if it receives a strong jolt, which may result in fire or
electric shock if the equipment is used without being repaired.
Do not use any power source other than the one provided with this equipment.
Otherwise, improper power connection may lead to fire or electric shock.

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Copyright © iRay Technology Co., Ltd.
Only dedicated cables can be used on this equipment. Do not use any cable other
than those supplied with this product.
The power cord plug must be firmly inserted into the power socket.
If contact failure occurs, or if metal objects come into contact with the exposed metal prongs
of the plug, fire or electric shock may result.
Do not supply power to more than one piece of equipment using the same AC outlet.
Doing so may result in fire or electric shock.
Do not connect a multiple portable socket-outlet or extension cord to the equipment.
Otherwise, it may result in fire or electric shock.
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 immediately in case of an
emergency.
Be sure to disconnect the power cable by holding the plug or connector, not by
pulling the cable.
If you pull the cable too hard, the core wire may be damaged, resulting in fire or electric
shock.
1.2.3 Handling
!
WARNING
Personnel not authorized by iRay are prohibited to open the equipment enclosure.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
Do not touch the interface and power unit or cable and the patient at the same time.
Do not let the patient touch the interface and power unit or cable. Have the patient take
a fixed posture and do not let the patient touch parts unnecessarily.
Ignoring this warning may cause electrical shock and/or unknown hazards, which may result
in severe personal injury, death, or substantial product damage.
PROHIBITED
Do not handle the equipment with wet hands.
Otherwise, it may result in electric shock that could result in death or serious injury.
Make sure the equipment is used on a flat and stable surface to prevent bending and
deformation of the equipment.
Otherwise, the internal image sensor may get damaged.
If the 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.
Otherwise, the detector may tip over, causing injury to the patient, or damage to internal
equipment.
Keep the detector under even load (same pressure) during image acquisition.
Otherwise, the quality of acquired images is not guaranteed.
Do not spill liquids or chemicals onto the equipment. Do not let the equipment come
into contact with the patient's blood or other body fluids.
Otherwise, it may result in fire or electric shock. For avoiding such contact, the disposable
protective covers should be used to protect the equipment.

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Do not place any superfluous objects within the moving range of the parts of this
product.
Disconnect the power supply when the equipment is not used for the sake of safety.
1.2.4 Failure Handling
!
CAUTION
Turn off the detector, unplug the adapter or battery power cord immediately and
contact your sales representative or local iRay distributor if any of the following occurs:
When there is smoke, an odd smell or abnormal sound
When liquid has been spilled into the equipment or a metal object has entered the
equipment through an opening
When the equipment has been dropped and is damaged
When liquid has been spilled into or on any part of the X-ray detector or power
supply (if applicable), or when the X-ray detector, its component, or accessory is
dropped, unplug the power supply from the AC outlet, and immediately contact your
sales representative or local iRay distributor.
Further use under abnormal conditions may result in severe personal injury, death, or
substantial product damage.
1.2.5 Battery
!
CAUTION
If the enclosure is broken or overheating, or emits unusual odors, smoke, or leaks
anything. Avoid contact with any material leaking from the battery pack.
If any liquid comes into contact with your skin or eyes, wash the affected area with clean
running water and seek immediate medical attention.
Do not hit or squeeze the battery. Do not insert any object into the battery or use
any device to pry open the battery pack case.
Attempting to doing so will damage the battery case, which may cause the battery to release
toxic and hazardous substances, resulting in injuries such as electric shock, burns, or fire, and
render the battery unusable.
Replacement of battery by unauthorized users or incorrect replacement of battery
may cause electric shock, burns, or fire, and render the battery unusable.
PROHIBITED
Keep the battery away from fire, do not use it at high temperature, and do not
charge the battery near flammable materials.
Do not invert positive and negative poles.
Do not touch the battery with metal to prevent short circuit.
Do not use non-standard batteries.
Do not change the internal structure of the battery.
Do not immerse the battery in water or other liquids, keep it dry when using the
battery.
Do not use batteries not provided by iRay.
Do not charge damaged batteries or charge batteries with damaged chargers.

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Copyright © iRay Technology Co., Ltd.
Do not use the battery charger around the patient.
Please remove the battery when the detector is not used for a long time.
1.2.6 Maintenance and Inspection
!
WARNING
Be sure to turn off the power of detector when the inspections indicated in this
manual are going to be performed. If the detector is powered by AC power supply, turn
off the power switch and/or unplug the AC power cord. If the detector is powered by a
battery, remove the battery.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
NEVER use alcohol, ether and other flammable cleaning agent to clean the
equipment for the sake of safety. NEVER use methanol, benzene, acid, alkali or other
corrosive liquids to clean the equipment.
The X-ray detector must be repaired by X-ray detector manufacturer authorized
personnel only.
Ignoring this warning may result in explosion, fire, electric shock, or unknown hazards,
which may result in severe personal injury, death, or substantial product damage.
!
CAUTION
Clean the plug of power cord periodically by unplugging it from the AC outlet and
remove dust and dirt from the plug, its periphery and AC outlet with a dry cloth.
If the power cord is left plugged in for an extended period of time in a dusty, dark and humid
environment, the dust around the outlet will absorb moisture, possibly causing insulation
failure and a fire.
Make sure that the equipment’s surface & plugs are dry before turning ON the
power.
Otherwise, it may result in fire or electric shock.
1.3 Notes for Using the Equipment
Pay attention to the following precautions when using the equipment. Otherwise, the equipment may not function
correctly.
Before Exposure
Be sure to check the connection of all the parts are set properly & check the detector is kept in insulated cover
that operator or patient can’t touch the detector directly before powered up.
Be sure to check the equipment daily and confirm that it works properly.
When room is heated up suddenly in cold areas, it will cause condensation on the equipment. In this case, wait
until the condensation evaporates before performing an exposure. If condensation occurs during the use of the
equipment, the images captured may suffer from quality problems. When an air-conditioner is used, be sure to

Luna1012X User Manual Safety Information
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raise/decrease temperature gradually to ensure that the temperature difference between room and equipment
will not cause condensation.
The detector should be warmed up for 20 minutes before exposure or creation of calibration template.
Make sure wave form of the energy going to the X ray tube is square not pulse.
Be cautious with circumstance that someone has radio isotope recently injected into them, it may cause panel
transmit image without x ray.
Once powered off, please wait at least 60s before power on again.
During Exposure
Do not move the power cable or Ethernet cable during exposure. Otherwise, it may cause image noise, artifacts or
incorrect images.
Do not use the equipment in areas with strong magnetic field. Otherwise, it may cause image noise, artifacts or
incorrect images.
Do not use the equipment in areas with vibration. Otherwise, it may cause image noise, artifacts or incorrect
images.
After Exposure
Turn off the power to the detector when the flat panel detector is not used.
Disinfection and Cleaning
After every examination, wipe the patient contact surfaces of the detector using disinfectants such as ethanol, to
prevent the risk of infection. For details on how to sterilize, consult a specialist.
1Do not spray the detector directly with disinfectants or detergents.
2Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, thinner,
benzene, acid and base. Doing so may damage the surface of the equipment.
3It’s recommended to use a waterproof non-woven cover as the isolated layer between detector and the blooding
patient.

Luna1012X User Manual Regulatory Information
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Copyright © iRay Technology Co., Ltd.
2 Regulatory Information
2.1 Medical Equipment Classification
The detector has two power supply modes (power adaptor and battery pack) and two ways of signal transmission
(wireless or wired transmission).
Protection Type Against Electrical Shock
Class I equipment, using medically approved adaptor supply
Internally powered equipment, using battery power supply
Degree of Protection Against Electrical Shock
B Type
Mode of Operation
Continuous operation
Flammable Anesthetics
Not suitable for use in situation with flammable anesthetic
mixture with air, oxygen or nitrous oxide
Not suitable for use in oxygen-rich situation
2.2 Safety Standard Reference
The applicable safety standards for this product covers the product host, battery charger, rechargeable battery (if
applicable) and other accessories.
IEC 60601-1-1-2-2014
Medical electrical equipment-Part 1-2 General requirements for basic safety
and essential performance-Collateral Electromagnetic Disturbances-
Requirements and tests (Edition4.0)
IEC 60601-1-2012
Medical electrical equipment-Part 1: General requirement for basic safety and
essential performance (Edition3.1)
IEC 60601-2-54-2018
Medical electrical equipment-Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and
radioscopy (Edition1.2)
IEC 60601-1-6-2013
Medical electrical equipment-Part1-6: General requirements for basic safety
and essential performance-collateral standard: Usability (Edition3.1)
2.3 Guidance and Manufacturer’s Declaration For EMC
2.3.1 EMI Compliance Table
Emissions

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Phenomenon
Compliance
Electromagnetic Environment
RF emissions
CISPR 11
Group 1, Class B
Professional healthcare facility environment
Harmonic distortion
IEC 61000-3-2
Class A
Voltage fluctuations and
flicker
IEC 61000-3-3
Compliance
2.3.2 EMS Compliance Table
Enclosure Port
Phenomenon
Basic EMC Standard
Immunity Test Levels
Professional Healthcare Facility
Environment
Electrostatic
Discharge
IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field
IEC 61000-4-3
3V/m
80MHz-2.7GHz
80% AM at 1kHz
Near fields from RF wireless
communications equipment
IEC 61000-4-3
Refer to table “Near Fields from RF Wireless
Communications Equipment”
Rated power frequency
magnetic fields
IEC 61000-4-8
30A/m
50Hz or 60Hz
Near Fields from RF Wireless Communications Equipment
Test frequency
(MHz)
Band
(MHz)
Immunity Test Levels
Professional Healthcare Facility
Environment
385
380-390
Pulse modulation 18Hz, 27V/m
450
430-470
FM, ±5kHz deviation, 1kHz sine, 28V/m
710
704-787
Pulse modulation 217Hz, 9V/m
745
780
810
800-960
Pulse modulation 18Hz, 28V/m
870
930
1720
1700-1990
Pulse modulation 217Hz, 28V/m
1845
1970
2450
2400-2570
Pulse modulation 217Hz, 28V/m
5240
5100-5800
Pulse modulation 217Hz, 9V/m
5500
5785

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Input AC Power Port
Phenomenon
Basic EMC Standard
Immunity Test Levels
Professional Healthcare Facility
Environment
Electrical fast transients/burst
IEC 61000-4-4
±2 kV
100kHz repetition frequency
Surges
Line-to-line
IEC 61000-4-5
±0.5 kV, ±1 kV
Surges
Line-to-ground
IEC 61000-4-5
±0.5 kV, ±1 kV, ±2 kV
Conducted disturbances
induced by RF fields
IEC 61000-4-6
3V, 0.15MHz-80MHz
6V in ISM bands between 0.15MHz and
80MHz
80%AM at 1kHz
Voltage dips
IEC 61000-4-11
0% UT; 0.5 cycle
At 0º, 45º, 90º, 135º, 180º, 225º, 270ºand 315º
0% UT; 1 cycle
70% UT; 25/30 cycles
Single phase: at 0º
Voltage interruptions
IEC 61000-4-11
0% UT; 250/300 cycles
2.4 Battery Safety Standards
Standards
Description
IEC 62133-2:2017
Secondary cells and batteries containing alkaline or other non-acid electrolytes-
Safety requirements for portable seated secondary lithium cells, and for batteries
made from them, for use in portable applications-Part2: Lithium systems
(Edition1.0)
UN38.3
ST/SG/AC.10/11/Rev. 6 Amend. 1 38.3 UNITED NATIONS
“Recommendations on the TRANSPORT OF DANGEROUS GOODS’’ Manual
of Tests and Criteria ST/SG/AC. 10/11/Rev.6 Amend. 1 Section 38.3
2.5 FCC Compliance
Contains FCC ID: 2ACHK-01070189
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of

Luna1012X User Manual Regulatory Information
12
Copyright © iRay Technology Co., Ltd.
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. 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:
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 that to which the receiver is connected.
Consult the dealer or an experienced radio/ TV technician for help.
Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the
equipment.
2.6 Radio Frequency (RF) Energy
This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy
set by the Federal Communications Commission of the United States.
The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate,
or SAR. The SAR limit recommended by the general public is 1.6W/kg Averaged over one gram of tissue by IEEE Std
1528.
The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in
compliance with the FCC RF exposure guidelines. While there may be differences between the SAR levels of various
product and at various positions, they all meet the government requirements.
SAR compliance for body-worn operation is based on a separation distance of 0 mm between the unit and the human
body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the
reported level.

Luna1012X User Manual Product Introduction
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Copyright © iRay Technology Co., Ltd.
3 Product Introduction
Battery type: Battery - KX (Rechargeable lithium battery)
Battery charger: Charger - Combo
3.1 Overview
Luna1012X is a wireless digital X-ray flat panel detector based on amorphous flexible silicon thin-film transistor
technologies, which contains an active matrix of 3152×2502 with 100um pixel pitch.
It renders high quality radiographic images with the CSI (Caesium Iodide) scintillator which is direct deposit. Since
Luna1012X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system.
3.2 Scope of Application
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human
anatomy, but not intended for mammography or dental applications.
Use of this equipment in pregnant women is prohibited.
The remaining notes depend on the DR system.
3.3 Intended Use
This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem of
human.The image is obtained as the result of X-ray passing through the human anatomy and detected by the
equipment. iRay will provide equipment and software support for integration of system.