iRay Technology Luna1012X User manual

Wireless Digital Flat Panel Detector
Luna1012X
User Manual
Version ：A0
Doc ID ：166-201-02
Release Date:：2021.01.13
Before operating, please read this user manual and pay attention to all safety precautions.
Please ensure that this user manual is properly maintained so that it can be accessed at any time
(reserve).
E

Please use it correctly based on full understanding of the content.

To Customers
User Manual of Luna1012X 1
Congratulations on your purchase of the Flat Panel Detector (hereinafter referred to as Luna1012X)
which is manufactured by iRay Technology Company Ltd. (Hereinafter referred to as iRay).
Please take time to read through this user guide in order to utilize the product effectively. We hope
you enjoy the experience with iRay Luna1012X.
If you have any questions or suggestions, please feel free to contact us.
To Customers
Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter referred
to as Luna1012X) which is manufactured by iRay Technology Co.Ltd. (Hereinafter
referred to as iRay).
At iRay, we strive to not only make the world-class products that deliver the best
value possible to our customers but also offer the highest quality of service and
customer care. Please take time to read through this user guide in order to utilize the
product effectively. We hope you enjoy the experience with iRay Luna1012X
If you have any questions or suggestions, pleasedo not hesitate to contact us.
Notes on usage and management of the equipment
1. Read all of the instructions in the user guide before your operation. Give particular attention
to all safety precautions.
2. Only a physician or a legally certified operator should use this product.
3. The equipment should be maintained in a safe and operable condition by maintenance
personnel.
4. Use only the dedicated cables. Do not use any cables other than those supplied with this
product.
5. Request your sales representative or local iRay dealer to install this product。

Wireless Digital Flat Panel Detector
2 User Manual of Luna1012X
Caring for your environment
This symbol indicates that this product is not to be disposed of with your residential or
commercial waste.
Recycling iRay Equipment
Please do not dispose of this product with your residential or commercial waste. Improper
handling of this type of waste could have a negative impact on health and on the environment.
Some countries or regions, such as the European Union, have set up systems to collect and recycle
electrical or electronic waste items. Contact your local authorities for information about practices
established in your region. If collection systems are not available, call iRay Customer Service for
assistance.
Disclaimer
1. 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.
2. 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.
3. 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 by iRay
Technology.
4. It is the responsibilities of the user/attending physicians for maintaining the privacy of image
data and providing medical care services. iRay shall not be responsible for the legality of
image processing, reading and storage nor it shall be responsible for loss of image data for
any reason.
5. Information regarding specification, compositions, and appearance of this product is subject
to change without prior notice.
Copyright

To Customers
User Manual of Luna1012X 3
All rights reserved
No part of this publication may be reproduced in any form or by any means without the written
permission of iRay. The information contained herein is designed only for use with iRay Luna1012X.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd.

Wireless Digital Flat Panel Detector
4 User Manual of Luna1012X
Symbols and Conventions
The following symbols and conventions are used throughout the user guide.
Identify the conditions under which improper use of the
product may cause death or serious personal injury.
Identify conditions under which improper use of the
product may cause minor personal injury.
Identify conditions under which improper use of the
product may cause property damage.
Indicate a prohibited operation.
Indicate an action that must be performed
Indicate important operations and restrictions.
Indicate operations for reference and complementary
information.

To Customers
User Manual of Luna1012X 5
Labels and markings on the equipment
The contents of the label and mark on iRay Luna1012X product are indicated as below:
Symbol
Description
Caution: please refer to the instructions in the user manual.
Indicates that the equipment has passed CE testing and the CE
Notified Body number follows it.
Serial number of the product.
Name and address of the manufacturer.
Manufacturing date of this product.
Expiring date of this product.
Name and address of iRay authorized representative in the
European region.
Consultation of the user guide for general information.
This product is not to be disposed of with your residential or
commercial waste.
Safety Signs:
Please refer to the user guide for safety instructions.
Safety Signs：
Dangerous Voltage.

Wireless Digital Flat Panel Detector
6 User Manual of Luna1012X
Handled with care.
Operational temperature limits.
Storage temperature limits.
Fragile
Keep away from sunlight
Keep dry
Storage Humidity limits.
Keep the equipment up right.
Do not roll the transportation package.
Stacking limit number.
ON
Switch to this position means power on for part of the equipment
OFF
Switch to this position means power off for part of the equipment

Contents
User Manual of Luna1012X 7
Contents
CONTENTS................................................................................................................................... 7
1. GENERAL DESCRIPTION ..................................................................................9
1.1. Safety Precautions ...................................................................................... 9
1.2. Notes for Use.............................................................................................14
2. GENERAL DESCRIPTION ................................................................................16
2.1. Scope.........................................................................................................16
2.2. Principle.....................................................................................................16
2.3. Characteristics...........................................................................................17
2.4. Intended Use .............................................................................................17
2.5. ESSENTIAL PERFORMANCE..................................................................17
2.6. Application Specification............................................................................17
2.7. The relative position between newborns and detector..............................18
2.8. Product Components.................................................................................18
2.9. Environment...............................................................................................19
2.10. Components Dsecription .........................................................................19
2.11. Product Specification.................................................................................22
3. BASIC OPERATION ..........................................................................................28
3.1. Preparation................................................................................................28
3.2. Routine Operation .....................................................................................29
3.3. Battery Charger Installation........................................................................31
4. SOFTWARE SETUP .......................................................................................... 32
4.1. System requirement ................................................................................32
4.2. Environment setup...................................................................................32
4.3. Wireless Connection................................................................................32
4.4. Software UI..............................................................................................37
4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-
NETWORK .........................................................................................................55
5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION............................57
5.1. Steps for acquiring image........................................................................57
5.2. Software Mode ........................................................................................57
5.3. AED Mode...............................................................................................59
5.4. After use..................................................................................................60
5.5. Correction and Calibration Template Generation....................................61
5.6. Local Image Check..................................................................................65
5.7. Firmware Upgrade...................................................................................67
6. REGULATORY INFORMATION........................................................................69
7. TROUBLE SHOOTING ...................................................................................... 71
8. SERVICE INFORMATION ................................................................................. 72
8.1. Service Office Information.......................................................................72

Wireless Digital Flat Panel Detector
8 User Manual of Luna1012X
8.2. Product Lifetime.......................................................................................72
8.3. Regular Inspection and Maintenance......................................................72
8.4. Repair......................................................................................................72
8.5. Replacement Parts Support....................................................................73
APPENDIX A INFORMATION OF MANUFACTURES ..............................................................74
APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE............................................75

1. Safety Information
User Manual of Luna1012X 9
1. General Description
1.1. Safety Precautions
Follow these safeguards and properly use the equipment to prevent injury and damage to any
equipment/data
WARNING
Installation and environment
of use
Do not use or store the equipment near flammable
chemicals such as alcohol, thinner, benzene, etc.
If chemicals spill or evaporate, it may 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 may result in fire or electric shock.
All the patients with active implantable medical devices
should keep away from the equipment.
Power supply
Do not operate the equipment using any type of power
supply other than the one indicated on the rating label.
Otherwise, it may result in fire or electric shock.
Do not handle the equipment with wet hands.
You may experience electric shock that could result in death or
serious injury.
Do not place heavy object such as medical equipment on
cables and cords. 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 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 turn ON the system power when condensation has
formed on the equipment.
Doing so may result in fire or electric shock.

Wireless Digital Flat Panel Detector Luna1012X
10 User Manual of Luna1012X
Power supply
Do not connect a multiple portable socket-outlet or
extension cord to the system.
Doing so may result in fire or electric shock.
To avoid the risk of electric shock, this equipment must
only be connected to power supply with protective earth.
Not doing so may result in fire or electric shock.
Securely plug the power cord into the AC outlet.
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.
Be sure to turn OFF the power to each piece of equipment
before connecting or disconnecting the cords.
Otherwise, you may get an electric shock that could result in death
or serious injury.
Be sure to hold the plug or connector to disconnect the
cord.
If you pull the cord, the core wire may be damaged, resulting in fire
or electric shock.
WARNING
Handling
Never disassemble or modify the equipment. No
modification of this equipment is allowed. Parts of the
Luna1012X that are not serviced or maintained while in use
with the patient.
Doing so may result in fire or electric shock. Also, since the
equipment incorporates parts that may cause electric shock as well
as other hazardous parts, touching them may cause death or serious
injury.
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 may
result in fire or electric shock.
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 put the equipment and pointed objects together.
The equipment may be damaged. If so, the equipment should be
used in bucky.

1. Safety Information
User Manual of Luna1012X 11
Have the patient take a fixed posture and do not let the
patient touch parts unnecessarily.
If the patient touches connectors or switches, it may result in electric
shock or malfunction of the equipment.
When a problem occurs
Should any of the following occurs, immediately unplug the
powercable or battery, and contact your sales
representative or local iRay 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 damaged.
Maintenance and inspection
Please turn OFF the power of the equipment and unplug the
power cord of adaptor before cleaning.
NEVER use alcohol, ether and other flammable cleaning
agent for safety. NEVER use methanol, benzene, acid and
base because they will erode the equipment.
DON'T dip the equipment into the liquid.
Please make sure that the equipment's surface & plugs are
dry before turning ON.
Otherwise, it may result in fire or electric shock.
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; this could
cause insulation failure that may result in a fire.
For safety reasons, be sure to turn OFF the power to each
piece of equipment when performing inspections indicated
in this manual.
Otherwise, electric shocks may occur.
CAUTION

Wireless Digital Flat Panel Detector Luna1012X
12 User Manual of Luna1012X
Installation and environment
of use
Do not install the equipment in any of the locations listed
below. Doing so may result in failure, malfunction,
equipment falling, 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 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 areas prone to vibration
On an incline or in an unstable area
Take care that cables do not become tangled during use.
Also, be careful not to get your feet caught by cable.
Otherwise, it may cause a malfunction of the equipment or injury of
the user due to tripping over the cable.
Power supply
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.
Be sure to ground the equipment to an indoor grounded
connector. Also, be sure to connect all the grounds for the
system to a common ground.
Do not use any power source other than the one provided
with this equipment.
Otherwise, fire or electric shock may be caused due to leakage.
Handling
Do not spill liquid or chemicals onto the equipment. In case
the patient is injured, it is not allowed to contact with blood
or other body fluids.
Doing so may result in fire or electric shock.
In such a situation, protect the equipment with a disposable cover as
necessary.
Turn OFF the power and pull out the plug to each piece of
equipment for safety when not used.
CAUTION

1. Safety Information
User Manual of Luna1012X 13
Handling
Handle the equipment carefully.
Do not submerge the equipment in water.
The internal image sensor may be damaged if something
hits against it or it is dropped.
Do not place excessive weight on the equipment.
Be sure to use the equipment on a protected foam.
Otherwise, the internal image sensor may be damaged. Be
sure to securely hold the detector while using it in upright
positions. Otherwise, the detector may fall over, resulting in
injury to the user or patient, or may flip over, resulting in
damage to the inner device.
Keep the same load (same pressure) on the detector when acquiring
the image. Or the image will be incorrect.
CAUTION

Wireless Digital Flat Panel Detector Luna1012X
14 User Manual of Luna1012X
Do not operate close to fire, do not use in high temperatures
Do not invert positive and negative poles
Do not contact with metal in case of a short circuit
Do not insert sharp objects into the battery
Do not hit the battery
Do not stand on the battery
Do not use the battery for purposes other than those
stipulated in the rules
Do not dispose of the battery or change its internal
structure
Do not submerge the battery in water; please keep it dry in
storage and do not contact with water while in use
Please charge the battery with the charger provided by
Manufacturer
Do not mix the battery with ones not provided by
Manufacturer
Do not charge the battery with a broken charger.
Charge the battery regularly to avoid over-discharge failure.
Do not use the battery when it is severe ballooning.
1.2. Notes for Use
When using the product, take the following precautions. Otherwise, problems may occur and the
product 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 product daily and confirm it work properly.
⚫Sudden heating of the room in cold areas will cause condensation on the product. In this
case, wait until the condensation evaporates before performing an exposure. If it is used when
condensation is formed, problems may occur in the quality of captured images. When an air-
conditioner is used, be sure to raise/lower the temperature gradually to prevent
condensation.

1. Safety Information
User Manual of Luna1012X 15
⚫The product should be warmed up for 15 minutes before exposure or updating the gain map
and defect map.
⚫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 Power Cable or Ethernet Cable during exposure, or it may cause image noise or
artifacts, even incorrect images.
⚫Do not use the product near the equipment generating a strong magnetic field. Otherwise, it
may cause image noise, artifacts or even incorrect images.
After Usage
⚫After every examination, wipe the patient contact surfaces with disinfectants such as ethanol,
to prevent the risk of infection. For details on how to sterilize, consult a specialist.
⚫Do not spray the product directly with disinfectants or detergents.
⚫Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as
alcohol, benzene and acid. Doing so may damage the surface of the product.
⚫It’s recommended to use a waterproof non-woven cover as the isolated layer between
product and the blooding patient.

Flat Panel Detector Luna1012X
User Manual of Luna1012X 16
2. General Description
Luna1012X（configuration：Luna1012X, hereinafter referred as Luna1012X ）is a wireless X-ray
flat panel detector based on amorphous flexible silicon thin-film transistor technologies. It is
developed to provide the good quality of radiographic image, which contains an active matrix of
3328×2560 with 100 um pixel pitch. The scintillator of Luna1012X is CsI(Caesium Iodide) which is
direct deposit. Since Luna1012X supports multiple trigger modes, it can satisfy both of the general
DR system and retrofit DR system.
2.1. Scope
This manual contains information about iRay Luna1012X product. All operators must read and
understand this manual before using equipment. All information in this manual, including the
illustrations, is based on equipment prototype. If configuration of your equipment does not have
any of these items, information about these items in the manual does not apply to your
equipment.
2.2. Principle
Detectors contain a layer of scintillator material, which converts the x-rays into light. Directly
behind the scintillator layer is an amorphous silicon pixel array contains a photodiode which

2. General Description
User Manual of Luna1012X 17
generates an electrical signal in proportion to the light produced by the portion of scintillator layer
in front of the pixel. The signals from the photodiodes are amplified and encoded by additional
electronics positioned behind the sensor array in order to produce an accurate and sensitive digital
representation of the x-ray image.
2.3. Characteristics
⚫Wireless static flat panel detector
⚫AED
⚫802.11ac
⚫16-bit AD
2.4. 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. Luna1012X is a 10x12
wireless portable flat panel detector designed for human, especially for baby.
According to the Luna1012X intended use and the result of risk management, identifying and
describing the essential performance as the following:
To get image of dark field, the Luna1012X shall be not influenced to the imaging acquisition.
To keep the data transmission function, the Luna1012X shall be not influenced to the data and
signal transmission
2.5. ESSENTIAL PERFORMANCE
According to the Luna series INTENDED USE and the result of risk management, image acquisition
and data transmission are defined as ESSENTIAL PERFORMANCE.
Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE.
Method for getting dark image in detail refers to section “installation” and “operation”.
2.6. Application Specification

Wireless Digital Flat Panel Detector Luna1012X
18 User Manual of Luna1012X
PATIENT population:
Age: not relevant
Weight: not relevant
Health: not relevant
Nationality: multiple
Gender: except for pregnant women
Intended OPERATOR:
All of use, maintenance and operation steps should be carried out by the operator who has accepted
the professional training offered by the company's customer service staff.
2.7. The relative position between newborns and detector
Because of the crosstalk effect of Amorphous silicon flat-panel detector, Pay attention to the relative
position of newborns and detector, Otherwise, the image is prone to abnormal light lines.
2.8. Product Components
The product is configured with the components below
Item
Description
Quantity
Luna1012X Detector
/
1pcs
Adapter
/
1pcs
Battery pack
/
2pcs
Gigabit Ethernet cable
/
1pcs
AC power cable
/
1pcs
DC power cable
/
1pcs
Battery charger
/
1pcs
CD ROM
/
1pcs