iRay Technology Pluto0001X Bedienungsanleitung
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
9
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:
10
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.
Dieses Handbuch passt für folgende Modelle
1
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