iRay Technology Canis014D07 User manual

User Manual
Canis014D07
Portable X-ray System
E
IMAGING THE FUTURE
Document version: A0
Document ID: 921-201-02
Release date: 5/13/2022
E

To Customers
iCanis014D07 User Manual
To Customers
Thanks you for purchasing the CANIS014D07 Portable X-Ray System (hereinafter referred to as CANIS014D07)
from iRay Technology Taicang Ltd. (hereinafter referred to as iRay) as your X-ray solution.
This manual contains all the general information about the CANIS014D07, which is intended to provide users with
instructions on installation, operation 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, and appearance of this product is subject to change without
prior notice.
Store this manual safely so that you can access it in the future.
Do not operate this equipment until you have fully read this manual.
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 “iRay” and iRay logo 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.

To Customers
Canis014D07 User Manual ii
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.
Disclaimer
In no event shall iRay be reliable for any abnormality, equipment damage and personal injury caused due to
your failure to follow the warnings and operating instructions in this manual.
In no event shall iRay be reliable 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.
In no event shall iRay be reliable for 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.
In no event shall iRay be reliable 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 user and operator are responsible for maintaining the privacy of image data acquired from this product.
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 property damage.
!
CAUTION
This indicates a potentially hazardous situation which, if ignored, may result in minor
personal injury or property damage.
PROHIBITED
This symbol is used to indicate a prohibited operation.
NOTE
This emphasizes or supplements important information about the main text.
REFERENCE
This symbol is used to indicate "Consult other sections of this manual for information".

To Customers
iii Canis014D07 User Manual
Abbreviations
Abbreviations
Explanation
FCC
Federal Communications Commission
SSD
Source-to-Skin Distance
SN
Serial Number
UI
User Interface
WL
Window Level
WW
Window Width

Contents
Canis014D07 User Manual iv
Contents
TO CUSTOMERS .......................................................................................................................................................I
CONTENTS ............................................................................................................................................................ IV
1 SAFETY PRECAUTIONS ...................................................................................................................................6
1.1 Radiation Safety ......................................................................................................................................................6
1.2 Equipment and Power Source .................................................................................................................................6
1.3 Battery .....................................................................................................................................................................7
1.4 Operation ................................................................................................................................................................ 7
1.5 Failure Handling ..................................................................................................................................................... 8
1.6 Environment ........................................................................................................................................................... 8
2 REGULATORY INFORMATION ........................................................................................................................8
2.1 Labels and Symbols ................................................................................................................................................ 9
2.2 Safety Standards for Medical Equipment ............................................................................................................. 11
2.2.1 Medical Equipment Classification ...........................................................................................................11
2.2.2 Product Safety Standards ......................................................................................................................... 11
2.3 FCC .......................................................................................................................................................................12
3 PRODUCT INTRODUCTION .......................................................................................................................... 14
3.1 Overview ...............................................................................................................................................................14
3.2 Intended Use ......................................................................................................................................................... 14
3.3 Key Features ......................................................................................................................................................... 14
3.4 Contraindication ................................................................................................................................................... 14
3.5 Product Components .............................................................................................................................................15
3.6 Product Description .............................................................................................................................................. 15
3.7 Component Installation .........................................................................................................................................16
3.7.1 Battery Replacement ................................................................................................................................16
3.7.2 Battery Removal ...................................................................................................................................... 16
3.8 Application Scenarios ........................................................................................................................................... 16
3.9 Recommended Exposure Time .............................................................................................................................17
4 TECHNICAL SPECIFICATIONS ........................................................................................................................18
4.1 Portable X-Ray System .........................................................................................................................................18
4.2 Adapter ................................................................................................................................................................. 20
4.3 Battery ...................................................................................................................................................................20
5 USER INTERFACE ......................................................................................................................................... 22
5.1 Login Page ............................................................................................................................................................ 22
5.2 Home page ............................................................................................................................................................ 23
5.3 Patient Information Page ...................................................................................................................................... 24
5.4 Image Acquisition Page ........................................................................................................................................24

Contents
vCanis014D07 User Manual
5.5 Image View Page ..................................................................................................................................................26
5.6 Setting Page .......................................................................................................................................................... 27
6 SERVICE INFORMATION .............................................................................................................................. 31
6.1 Service Life ...........................................................................................................................................................31
6.2 Periodic Inspection and Maintenance ...................................................................................................................31
6.3 Disinfection and Cleaning .................................................................................................................................... 32
6.4 Troubleshooting .................................................................................................................................................... 32
6.5 Company Information ...........................................................................................................................................32
6.6 Manufacturing Site............................................................................................................................................... 33

Safety Precautions
Canis014D07 User Manual 6
1 Safety Precautions
To avoid personal injury or product damage, be sure to read the user manual and all accompanying documents
carefully and pay attention to all safety precautions before using the equipment. Operation and Maintenance must be in
accordance with the instructions contained in this manual.
1.1 Radiation Safety
This equipment may be dangerous to the patient and operator unless safe exposure factors and operating instructions
are observed.
!
WARNING
The owner and/or operator of this equipment to comply with all applicable rules and
regulations concerning radiation safety and protection in their area.
Excessive exposure to X-ray radiation is harmful.
Verify the exclusion zone is clear of all personnel. Failure to comply may result in personnel
injury.
All users should comply with the Radiation Protection Policies established by the
government.
!
CAUTION
All users and patients should wear protective garment, such as a lead apron which is
covered until collar, for radiation protection.
Do not enable this equipment until patient and operator are positioned and ready for
the exposure, reducing the likelihood of interruption and preventing inadvertent
exposure of anyone to x-rays.
1.2 Equipment and Power Source
!
WARNING
To avoid risk of electrical shock, this equipment must only be connected to a supply
mains with protective earth when charging.
Use only the supplied adapter provided by iRay.
The equipment may be damaged if you use another power adapter.
!
CAUTION
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.
Be sure to disconnect the power cable by holding the plug or connector, not by pulling
the cable itself.
If you pull the cable too hard, the core wire may be damaged, resulting in fire or electric
shock.

Safety Precautions
7Canis014D07 User Manual
1.3 Battery
!
WARNING
Observe and follow all safety information in this manual and on the warning labels on
the battery.
Ignoring this warning could result in personal injury or product damage.
Do not charge the battery in the environment with patient.
Do not use batteries not provided by iRay, do not charge damaged battery, or charge
battery with damaged adapter. If the enclosure is broken or emits unusual odors,
smoke, overheats, 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.
!
CAUTION
If the equipment is not used for an extended time period, charge the battery once every
3 months.
After full charge, at least 1 exposure has to be made to keep the battery in best function.
The battery is a consumable part. After several months, the battery capacity may slowly
decrease.
For reliable function and safety, battery pack should be replaced when its capacity is
noticeably decreased.
1.4 Operation
Operation should be performed only by qualified and trained dentists, radiologists, dental hygienists, or maintenance
service technicians who are experienced in installing and servicing dental X-ray systems.
!
WARNING
Do not try to disassemble or modify the equipment, and its accessories. No modification
of this product is allowed. Do not open the equipment enclosure.
Have the patient take a fixed posture and do not leave the device within the reach of a
patient.
Ignoring this warning may cause electrical shock and/or unknown hazards, which may result
in severe personal injury, death, or substantial product damage.
Pregnant women should not be exposed to X-rays unless it is strictly necessary.
!
CAUTION
Try not to move the equipment or incur vibration during X-ray exposure.
The image will not be clear if the equipment moves or there is a vibration during X-ray
exposure.
Do not handle the equipment with wet hands.
Otherwise, it may result in electric shock that could result in death or serious injury.

Safety Precautions
Canis014D07 User Manual 8
1.5 Failure Handling
!
CAUTION
Turn off the equipment 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
When the equipment has been dropped and is damaged
1.6 Environment
The equipment should be stored and operated in a specified dental clinic environment and maintained by professional
maintenance personnel under safe and operable conditions.
!
WARNING
Static electricity may affect this device at any time. Please use this device within the
permissible range of humidity defined by the specifications. Please refrain from wearing
a garment that may generate such static electricity.
!
CAUTION
Do not store the equipment or its parts in places listed below:
Water sources
Heat sources that produce heat
In an area prone to vibration
Chemicals or gases are generated
Where flammable materials are placed
Oxygen-rich environment
Other than the specified storage environment
The equipment can be used at an altitude of less than 3,000 meters.

Regulatory Information
9Canis014D07 User Manual
2 Regulatory Information
2.1 Labels and Symbols
The detector and other components have labels and symbols on them. Their contents and locations are indicated below.
The labels in this document are only examples, please refer to the actual labels.
Product Label
A sample label is shown in the figure below. The label information includes model, SN, manufacturer information and
other information.
iRay Imaging Technology (Haining) Limited
No. 2, Caohejing RD., Haining, Jiaxing, Zhejiang, China 314499 20XX-XX-XX
Model ：Canis014D07
Power Input ：Adapter Port Input 24V DC
Battery Port Input 18V DC
Portable X-ray System
(01)0697056909XXXX
(11)XXXXXXXX
(21)XXXXXXXXXXXXXXXXXXX
Contains FCC ID: 2ACHK-01070189

Regulatory Information
Canis014D07 User Manual 10
Labels on the Battery
Symbol
Explanation
Location
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
Product label
This symbol indicates the name and address of manufacturer. The date of
manufacture is combined in this symbol.
Product label
!
Caution: please refer to the instructions in the user manual.
Product label
This symbol represents reference to the user manual for general
information.
Product label
This symbol indicates that the product must be sent to the appropriate
facility for recycling when the end user intends to discard the product.
Product label
Battery label
This symbol represents a safety symbol that indicates "reference to user
manual".
Product label

Regulatory Information
11 Canis014D07 User Manual
This symbol is used to indicate that the product is a medical device.
Product label
This symbol is used to represent nonionizing electromagnetic radiation.
Product label
This symbol indicates a carrier that contains unique device identifier
information.
Product label
This symbol is used to indicate Federal Communications Commission
certificate.
Product label
2.2 Safety Standards for Medical Equipment
2.2.1 Medical Equipment Classification
Item
Classification
Type of protection against
electrical shock
Class I ME equipment, using the medical approved adaptor;
Internally powered ME equipment, using the internal battery
Degree of protection against
electrical shock
Without applied part
Degree of protection against
ingress of water
IPx0
Mode of operation
Continous operation
Flammable anesthetics
CAN NOT be suitability for use in an OXYGEN RICH ENVIRONMENT
2.2.2 Product Safety Standards
Standard
Description
IEC 60601-1:2005 + A1:2012
/EN 60601-1:2006 + A1:2013
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
ANSI/AAMI ES60601-1:2005
+ A1:2012 + Amendment
2:2010
Medical Electrical Equipment – Part 1: General requirements for safety and
essential performance
CSA CAN/CSA-C22.2 NO.
60601-1:14-2014
Medical Electrical Equipment – Part 1: General requirements for safety and
essential performance
IEC 60601-1-2:2014 /EN60601-
1-2:2015
Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard:
Electromagnetic disturbances – Requirements and tests
IEC 60601-1-3:2008 + A1:2013
/EN 60601-1-3:2008 + A1:2013
Collateral standard: General requirements for radiation protection in
diagnostic equipment.
IEC 60601-1-6:2010 +
A1:2013/EN 60601-1-6:2010 +
A1:2013
Medical electrical equipment -- Part 1-6: General requirements for basic
safety and essential performance -- Collateral standard: Usability

Regulatory Information
Canis014D07 User Manual 12
Standard
Description
IEC 60601-2-65:2013 +
A1:2017/EN 60601-2-65:2013
+ A1:2017
Medical electrical equipment - Part 2-65: Particular requirements for the
basic safety and essential performance of dental intra-oral X-ray equipment
IEC62366-1:2015/EN62366-
1:2015
Medical devices - Part 1:Application of usability engineering to medical
devices
IEC62133-2:2017/ EN62133-
2:2017
Secondary cells and batteries containing alkaline or other non-acid
electrolytes-safety requirements for portable sealed secondary lithium cells,
and for batteries made from them, for use in portable applications-part
2:lithium systems
UL62133-2:2020
Secondary cells and batteries containing alkaline or other non-acid
electrolytes-safety requirements for portable sealed secondary lithium cells,
and for batteries made from them, for use in portable applications-part
2:lithium systems
CSA C22.2 NO. 62133-2-20
Secondary cells and batteries containing alkaline or other non-acid
electrolytes-safety requirements for portable sealed secondary lithium cells,
and for batteries made from them, for use in portable applications-part
2:lithium systems
EN ISO 15223-1:2016
Medical devices—Symbols to be used with medical device labels, labeling
and information to be supplied—Part 1: General requirements
2.3 FCC
Contains FCC ID: 2ACHK-01070189
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1This device may not cause harmful interference.
2This 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
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.

Regulatory Information
13 Canis014D07 User Manual
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.

Product Introduction
Canis014D07 User Manual 14
3 Product Introduction
3.1 Overview
3.2 Intended Use
The Canis014D07 is a portable dental X-ray system for dental diagnosis in adult and pediatric patients and is available
only to trained and qualified dentist or dental technician.
Essential Performance
According to the IEC 60601-2-65, the clause 201.4.3.101, there are 2 potential essential performance:
a. Accuracy of loading factors;
b. Reproducibility of the radiation output
3.3 Key Features
Portable portable smart X-ray source
Intraoral X-Ray imaging
7” touch LCD display with high resolution (1024×600)
Rechargeable battery allows mobility, easy to operate and move
2 USB interfaces equipped
High capacity battery, up to 400 exposures on one full charge
Low radiation dose, safe and reliable
High specifications (70kV DC, 0.4mm focal spot) ensures high-quality images
Applicable to multiple application scenarios
All-in-one system, friendly user interface
3.4 Contraindication
Patients (children and pregnant women particularly) must wear lead aprons during their X-ray imaging.

Product Introduction
15 Canis014D07 User Manual
3.5 Product Components
Please check the following items carefully to ensure they are complete and confirmed by iRay engineers. If any items
are lost or damaged, please contact your iRay dealer.
No.
Item
Qty.
Remarks
1
Canis Smart P
1 pc.
Default
2
Adapter
1 pc.
Default
3
Power cord
1 pc.
Default
4
Battery
1 pc.
Default
5
Wrist strap
1 pc.
Default
6
Collimator Cone (200mm)
1 pc.
Default
3.6 Product Description
①
DI-IN
⑧
Power button (ON/OFF)
②
USB port
⑨
Product label

Product Introduction
Canis014D07 User Manual 16
③
Exposure indicator
⑩
Adjusting button
④
Control screen
⑪
Battery cover
⑤
Back scatter shield
⑫
Cradle head
⑥
Wrist buckle
⑬
Beam limiting device
⑦
Exposure button
3.7 Component Installation
3.7.1 Battery Replacement
To be added…
3.7.2 Battery Removal
To be added…
3.8 Application Scenarios
Smart P+iRay Sensor
Free from a computer, Smart P is an independent dental DR system and could finish the whole workflow: Patient
registration, image acquisition, image diagnostics.
Smart P+PC+iRay Sensor
Smart P is an independent dental DR system, and need a PC for Mini PACS installation.

Product Introduction
17 Canis014D07 User Manual
Smart P+Third Party Sensor
Smart P is just an X-Ray machine, which could adjust the exposure parameters easily, touch or button control.
3.9 Recommended Exposure Time
Tooth Position
Exposure Time of Digital Dental Film (s)
Maxillary incisor
0.08~0.10
Maxillary monocuspid
0.12~0.16
Maxillary bicuspids and first molar
0.12~0.16
Maxillary second and third molars
0.16~0.20
Mandibular incisor
0.06~0.08
Mandibular canine
0.10~0.16
Mandibular bicuspids and first molar
0.10~0.25
Mandibular second and third molars
0.10~0.25
NOTE
The exposure time set in each mode is recommended by the manufacturer, and each time can be
adjusted.

Technical Specifications
Canis014D07 User Manual 18
4 Technical Specifications
4.1 Portable X-Ray System
Drawing
±
±
⌀
⌀
Specifications
Item
Specification
Model
Canis014D07
Application
Intraoral X-Ray imaging
Output kV
70KV±10%
Output mA
2mA±20%
X-ray tube anode angle
12°
X-ray tube focal spot
0.4mm
X-ray exposure time range
0.1~2sec
HVG frequency
30kHz