iRay Technology Pluto0001X User manual

Digital Intra-oral X-Ray Imaging System
Pluto0001X /Pluto0002X
User's Manual
Document Version: A0
Document ID: 111-201-02
Release Date: 2020-12-08
Before operating, please read this user manual and pay attention to all safety
precautions.
Please ensure that this user's manual is properly maintained so that it can be
accessed at any time (reserve).
Please use it correctly on the basis of full understanding of the content.

To Customers............................................................................3
CONTENTS..............................................................................8
1. Safety Information................................................................................... 8
1.1 Safety precautions .............................................................................8
1.2 Notes for Using .................................................................................11
1.3 Storage and Operation Environment ................................................11
2. General Introduction................................................................................12
2.1 Indications for Use............................................................................12
2.2 Component of the imaging system.....................................................13
2.3 Timing and Electrical characteristics ............................................... 14
2.4 AED trigger sensitivity ....................................................................16
...............................................................................17
3. Information on Operation ........................................................................18
3.1 Installation and operation.................................................................18
3.2 Multi-sensor ...................................................................................... 18
3.3 Connect Sensor..................................................................................18
.............................................................................19
3.5 Create correction templates:............................................................. 20
3.6 Load template....................................................................................23
.............................................................24
4. Troubleshooting ....................................................................................... 25
4.1 Log.....................................................................................................25
4.2 Quick troubleshooting .......................................................................25
5. Information on Safety Regulations .........................................................26
5.1 Medical Equipment Safety Standards ...............................................26
5.2 Guidance and manufacture’s declaration for EMC .......................... 28
5.3 Environmental Directive ...................................................................30
6.Product Maintenance ................................................................................ 31
6.1 Expected Service Life ........................................................................31
6.2 Regular Inspection and Maintenance ............................................... 31
6.3 Repair................................................................................................32
6.4 Care and Cleaning ............................................................................32
Appendix ....................................................................................................33
A. Information of Manufacture................................................................33
B. Recommended exposure time.............................................................. 33

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
To Customers
Congratulations on your purchase of the Pluto0001X/
Pluto0002X Digital Intro-oral X-Ray Imaging System
(Hereinafter referred to as Pluto0001X/Pluto0002X) 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 good 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
Pluto0001X/Pluto0002X.
If you have any questions or suggestions, please feel free to
contact us.
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

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
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
iRay shall not be liable to the purchaser of this product or third
or abuse of this product.
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 by iRay Technology.
Information regarding specification, compositions, and
notice.
Copyright
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
Pluto0001X/Pluto0002X.
Trademarks
The iRay name and iRay logo are registered trademarks of
iRay Technology Co.Ltd.
Symbols and Conventions
The following symbols and conventions are used throughout
the user guide.

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
This symbol is used to identify conditions under
which improper use of the product may cause
This notice is used to identify conditions under
which improper use of the product may cause
This notice is used to identify conditions under
which improper use of the product may cause
property damage.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be
performed.
This is used to indicate important operations and
restrictions.
This is used to indicate operations for reference
and complementary information.
Labels and markings on the equipment
The contents of the labels and markings on iRay Pluto0001X/
Pluto0002X product are indicated below:
Caution: please refer to the instructions in the user
manual.

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
This symbol is used to identify the manufacture’s series
The series number of iRay products is usually made of
19 digits as shown below:
This symbol is used to indicate the name, address of
the manufacturer.
The date of manufacture, as well as the name and
address of the manufacturer, is combined in this symbol.
This symbol is used to indicate the name and address of
iRay authorized representative in the European Union.
This symbol is used to indicate consultation of the user
guide for general information.
Safety Signs: please refer to the user guide for safety
instructions.
Use-by date, Indicates the date after which the medical
device is not to be used.
Type BF applied part

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
IP Grade of the sensor according to IEC60529
Caution: Federal law restricts this device to sale by or
on the order of a physician.
Package symbol, fragile, handle with care
Package symbol, keep away from rain
Package symbol, keep away from sunlight
Package symbol, keep the way up, it shows the correct
upright position of the distribution packages for
transport and storage.
Package symbol, stacking limit by number, it shows
the maximum number of identical transport package
which may be stacked on the bottom one, where “n” is
the limiting number.
Package symbol, indicates the package shall be stored,
transported, and handled within temperature limits.
Package symbol, indicates the range of humidity to
which the medical device can be safely exposed.
CE marked product

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
CONTENTS
1. Safety Information
1.1 Safety precautions
Follow these safeguards and properly use the equipment to

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
WARNING
Installation
and
environment
of use
such as thinner, benzene, etc.
product damage through contact with electric parts inside the
equipment.
Do not connect the equipment with anything other than
Do not install or use in the following environment, or it may
Facilities near water sources
In direct sunlight
Close to air condition or ventilation
Dusty to a heat source as a heater
In a salty or acidic environment
High temperature and high humidity
Ice or condensation
In the environment easy to vibrate
On a slope or in an unstable area
Ensure that the cable is not knotted or wound during use.
WARNING
Handling Never disassemble or modify the equipment. No
Follow the below instructions to prevent damage to the
sensor and cable
Do not twist, bend, pull and pinch the cable strongly
Do not strike or drop the equipment.
Do not touch the pin of the USB connector
problem
occurs
Please unplug the USB connector when a problem happened
and contact the supplier or local dealer:

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Maintenance
and
inspection
Check the sensor and cable for any damage or abnormal
conditions
Check that the PC and software are working properly
CAUTION
Hygienic
protection
and cleaning
Hygienic protection
The sensor should be covered with hygiene sheath when you
apply the sensor to a patient
Note that a hygiene sheath whose is single use only. The bag
should be renewed for each patient to prevent any possible
transmission of infective agents.
Purchase the medical purpose sheath via formal purchase
channels:
Dental Intraoral Camera Sheaths
Cleaning
Pay special attention to avoid the risk of damage when cleaning
the sensor
the cable with soft cloth which is damped with 70% isopropyl
alcohol when the USB connector is not connected.
Do not apply any liquid or disinfectant to the product except 70%
isopropyl alcohol.
Do not immerse the sensor in disinfectants or any other chemicals
Do not sterilize the product by heating, autoclaving or UV
CAUTION
No valuable clinical obtained after exposure due to
operational reasons or failure of the device
The sensor performance was abnormal, no valuable clinical
images obtained after exposure due to the interference of the
equipment which is not conforming to IEC60601-1-2standard.
machine. Installation and software operation of this product,
please refer to the product user’s manual. For the other
operation, please refer to the operation manual of the x-ray
machine.

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
1.2 Notes for Using
Otherwise, problems may occur and the equipment may not
function correctly.
Before using
Please check whether the USB connector is dry or clean
before connecting the USB connector
Please hold the control box of the USB when plugging the
USB connector, do not touch the pin of USB connector
During using
Do not move the USB connector during the use of the
sensor
will increase. Please pay attention to the temperature of the
The detector should warm up for 15 minutes before
exposure or updating the gain map or defect map.
During exposure
Do not move the Cable or Sensor during exposure, or it
may cause image noise or artifacts, even incorrect images.
Do not use the devices near the equipment generating a
strong magnetic field. Otherwise, it may cause image noise,
artifacts or even incorrect images.
After using
After the USB port is pulled out, please take care of the
USB connector to avoid the risk of damage.
The sensor should be stored in a place free of chemicals
or gases and free from adverse factors such as pressure, high
into the product package box, to avoid damage.
1.3 Storage and Operation Environment

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Ensure that the sensor is stored and used in the following
environment:
Temperature Temperature
variation Humidity Barometric pressure
Barometric
change
Operation 20~90% RH 700~
1060mbar
hour
Storage 10~95% RH hour
,m0003nahteromedutitlanatarosnesehtetarepotonoD
the system connected with the sensor also can operate at an
altitude less than 3000m.
Do not expose the sensor to a hot and humid environment,
otherwise it may result in product damage
2. General Introduction
2.1 Indications for Use
The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/
medical units. The product is used for dental X-ray examination
and the diagnosis of structural diseases. The product is expected
to be used in hospitals and clinics, operated and used by trained
professionals under the guidance of doctors.
This device is not intended for mammography and
conventional photography applications.
This device is suitable for providing dental radiography
imaging for both adult and pediatric.
According to the expected use of Pluto0001X/Pluto0002X and
the result of risk assessment, the product essential performance
is identified: image acquisition of X-ray sensor and image
process.
This manual contains information about Pluto0001X/
Pluto0002X. All users should read and understand this manual
before using the product. All information in this manual,

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
including illustrations, is based on the device prototype. If the
device does not contain these contents, they will not apply to this
device.
2.2 Component of the imaging system
The component of digital intraoral X-ray imaging system are
sensor and image acquisition software iRayDR.
2.2.1 Image acquisition workstation
The image acquisition software iRayDR is used to acquire
and display the image, patient management, examination
management, image storage and image printing administration.
Note: the detail description of the image acquisition
workstation are showed in the user manual of the iRayDR.
2.2.2 Sensor
The pluto0001X and Pluto0002X feature a 20 µm pixel pitch
CMOS sensor with directly deposited CsI:Tl scintillator which
ensures optimal resolution. Made from a strong sealed Kevlar
shell, the sensor has an ergonomic design with smooth edges,
rounded corners, and a flexible cable for maximum patient
comfort. An easy to use hi-speed direct USB interface enables a
simple connection to a PC without need for an additional control
box. The optional iRay intra-oral software application makes it
easy to acquire, enhance, analyze, view and share images from
the Pluto 0001X/Pluto0002X sensor.
Fig.1 Pluto0001X outline(unit: mm)

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Fig.2 Pluto0002X outline(unit: mm)
Item Detailed information
Pixel matrix 1500×1000 1800×1300
Pixel Pitch
Scintillation Screen CsI
Sensor size 38.5mm×25mm×5mm 40mm× 31mm×5mm
AD Conversion 16bits
Spatial resolution Limited: 25lp/mm
Typical: >14.5lp/mm
Ingress Protection
IP68
(the highest point of enclosures with a height
greater than 1000mm below the surface of water,
and the duration of the test is more than 30
minutes)
Sensitivity >50lsb/uGy
Trigger sensitivity
Max linearity dose >400uGy
Length of cable <3m
interface Direct USB, USB2.0
Power
2.3 Timing and Electrical characteristics
Condition Min Type Max Unit
Integration time 0.05 4 s
Current consumption Image sensor head 30 50 mA
USB driver 200 350 mA
Readout time 1 1.5 s

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
AcqDelay 50 ms
Image cycle time 6 s
Trigger Mode
One is be triggered by the sensor automatically, the other
is trigged by the software command by an operator. Software
trigger mode is only used for debug and can be used by service
engineer who is authorized by iRay.
Type DC X-tube AC X-tube
mechanism Automatically detect
x-ray start and x-ray end
Only detect x-ray start;
x-ray end is pre-set by integration
time
Integration time Depend on X-ray width
AED(auto exposure detection) mode-DC x-ray tube
AED(auto exposure detection) mode-AC x-ray tube

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Software mode
2.4 AED trigger sensitivity
The AED trigger sensitivity should be matched with X-ray
source dose rate(correlated to power capacity) to achieve the
minimum X-Ray width, because the X-Ray during the AED
cycle time will not contribute to the image integration.
AED Trigger sensitivity
Level choose
AED cycle time(ms)
20 5.5
50 2.3
100 1.5
150 1.0
200 0.7
300 0.5
500 0.3
The x-ray machine used with intra-oral sensor in the current
is 60-70kV and 1-8mA. For different type of x-ray machine,
it is recommended to select the appropriate trigger threshold
according to the following tables:
kV mA SID
(mm)
Equivalent Skull size Min
Entrance
Dose
Rate(uGy/s)
Recommend
Trigger
Level(uGy/s)
Max
Entrance
Dose
Rate(uGy/s)
mA
(up to)
60 1 250 2mm Al 256 50 1000 4
8mm Al Standard 69
10mm Al Fat 51

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
65 1 250 2mm Al 306 50 1000 3.2
8mm Al Standard 91
10mm Al Fat 69
70 1 250 2mm Al 358 50 1000 3
8mm Al Standard 226
10mm Al Fat 90
kV mA SID
(mm)
Equivalent Skull size Min
Entrance
Dose
Rate(uGy/s)
Recommend
Trigger
Level(uGy/s)
Max
Entrance
Dose
Rate(uGy/s)
mA
(up to)
60 3.2 250 2mm Al 927 150 3000 8
8mm Al Standard 251
10mm Al Fat 186
65 3.2 250 2mm Al 1115 150 3000 8
8mm Al Standard 333
10mm Al Fat 253
70 3.2 250 2mm Al 1311 200 4000 8
8mm Al Standard 425
10mm Al Fat 330
according the actual dose rate.
System Recommand
CPU: IntelCore i3 (R) CPU: IntelPentium(R)
Memory: 4GDDR3/4 Memory: 4GDDR3/4
Preview Monitor:
1920×1080
Preview Monitor:
1280×768
Other hardware Support Serial port communication: USB2.0 port
OS
PC connected to the sensor must be approved by local
authorities: for example, by IT equipment safety certificate,
NRTL approval, etc..

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
3. Information on Operation
3.1 Installation and operation
This chapter mainly introduces the use of DEMO software
iDetector(service engineer) to connect the sensor and realize the
basic image acquisition and image processing functions.
The detector is connected to the computer via USB, and the
image data is transmitted via USB protocol.
3.2 Multi-sensor
Multi sensors can be supported by USB ports on PC, or using
self-power USB Hub. It up to 9 sensors.
Also, the snesor can be supported to connect by USB-Hub,
which can be powered by computer or external power.
3.3 Connect Sensor
Double-click to run the “iDetector.exe” in the SDK directory..\
3.3.1.

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Figure 3.3.1 Home interface
Note: select w32 or x64 according to the computer system.
After sensor is connection successfully, the Acquire tab will
Figure 3.3.2 Acuire interface
After the sensor connected successfully, you can set the AED
trigger mode in Detector interface according to the x-ray device.

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Parameters Description Note
Product No Product number Read only
Serial No Sensor serial number Read only
Main Version The Firmware version
number Read only
Read Version Read only
Set Delay Time(ms) Delay time Set before exposure and
only work in AC mode
Trigger Mode Trigger Mode
Three trigger mode:
AED_DC, AED_AC and
software.
Trigger Threshold(uGy/s) Trigger threshold Trigger threshold with
3.5 Create correction templates:
The creation steps of gain and defect are as follows:
1. Double-click iDetector.exe to open image acquisition
software, select detector from the list, select “Pluto0001X” and
click “Connect”, wait for successful connection.
Select calibrate tab to enter template generation page.