User Manual Canis014D07 Portable X-ray System EE IMAGING THE FUTURE Document version: Document ID: Release date: A0 921-201-02 5/13/2022
To Customers 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.
To Customers 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.
To Customers Abbreviations iii Abbreviations Explanation FCC Federal Communications Commission SSD Source-to-Skin Distance SN Serial Number UI User Interface WL Window Level WW Window Width Canis014D07 User Manual
Contents Contents TO CUSTOMERS .......................................................................................................................................................I CONTENTS ............................................................................................................................................................ IV 1 2 SAFETY PRECAUTIONS ...................................................................................................................................
Contents 6 v 5.5 Image View Page ..................................................................................................................................................26 5.6 Setting Page .......................................................................................................................................................... 27 SERVICE INFORMATION ..............................................................................................................................
Safety Precautions 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.
Safety Precautions 1.3 Battery 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.
Safety Precautions 1.5 Failure Handling ! 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 CAUTION When the equipment has been dropped and is damaged 1.
Regulatory Information 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.
Regulatory Information 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: A1A2A3A4 B1B2 C1C2 L M1M2D1D2Y1Y2 X1X2X3X4 Production Series No. Production Date Product label Production Site Production Version No. Derivative Type Production Type This symbol indicates the name and address of manufacturer. The date of manufacture is combined in this symbol.
Regulatory Information 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 2.2.1 2.2.
Regulatory Information Standard IEC 60601-2-65:2013 + A1:2017/EN 60601-2-65:2013 + A1:2017 IEC62366-1:2015/EN623661:2015 IEC62133-2:2017/ EN621332:2017 UL62133-2:2020 CSA C22.2 NO. 62133-2-20 EN ISO 15223-1:2016 2.
Regulatory Information 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.
Product Introduction 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.
Product Introduction 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.
Product Introduction 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 3.7.1 Component Installation Battery Replacement To be added… 3.7.2 Battery Removal To be added… 3.
Product Introduction 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 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.
Technical Specifications 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.
Technical Specifications Item Specification Power Input(adapter) 100-240V AC, 50/60Hz Focal length ≥200mm Exit filed size ≤60mm (Circle) Device power source Battery: 2400mAh - 400 exposures (full charge,70KV,2mA, 0.5sec, cycle time 15sec) -Standby mode(full charge): 1 week (Power off) -3 hours empty to full charging -2 months shipping mode: full charge -battery could be replaced by end-user Exposure control Hand switch / Button control / Remote control Sync with sensor IEEE802.
Technical Specifications Item Operation Storage & Transport Temperature range 10~40℃ -10~45℃ Humidity range 30%RH~75%RH 30%RH~75%RH Atmospheric pressure range (mbar) 700mbar~1060mbar 700mbar~1060mbar 4.2 Adapter Drawing 125.0±1.0 POWER LED 50.0±1.0 33.5±1.0 Specifications Item Specification Model LXCP61-024300 Input 100~240V AC input Output 24V single output mode, 72W 4.3 Battery Drawing +0.15 *53.6-0.
Technical Specifications Specifications Item Specification Model BATTERY-KS Rated capacity Typ.2500mAh; Min.2400mAh Nominal voltage 18V Limited charging voltage 21V Discharge cut-off voltage 12.5V Charge method CC-CV Operating temperature Charge: 0℃≤T≤20℃ 0.2C (500mA); 20℃＜T≤45℃ 1.2C (3000mA) Discharge: 20℃＜T≤45℃ 7.2C (18000mA); 45℃＜T≤60℃ 4.
User Interface 5 User Interface The interface mainly includes login page, work list page, patient information page, image acquisition page, image browsing page and setting page.
User Interface 5.2 Home page 6 1 2 1 3 4 5 The home page is mainly divided into 6 areas, and the main functions of each area are as follows: No.
User Interface 5.3 Patient Information Page Button Description Information modification Modify patient information, touch the name, birth date, gender, and click [Save] to save the modified information Addition of tooth position Touch the corresponding tooth position and click [Save] to add the tooth position to be examined Jump to the image acquisition page to examine the selected patient Back to Home page 5.
User Interface No.
User Interface 5.5 Image View Page In this page, you can perform some related operations on the image, including post-processing and image translation and rotation operations.
User Interface Item Description 5.6 Low threshold Adjust the low threshold of the image, the range is 0~5, the default value is 1 OK Click OK, and the processed image will be obtained if the set parameters do not exceed the range Exit Click the button to return to the image browsing interface, and the image is the processed image Setting Page This page is mainly used to set account, function, network, sensor, and application connection mode.
User Interface Button Sub Button Figure Description Change the password of the administrator account, click [OK] to change the password Reset the users' password: click [Reset Password] to change the account's password to 123456 Add, modify and delete users: click an account you want to operate and then click the corresponding add, modify and delete buttons to proceed to the next step The first boot prompts the user to start the exposurefor the first time; after six months, it prompts the user that
User Interface Exposure Time Setting You can enter the independent exposure mode by clicking the [application] button of the setting page and selecting the independent mode. The exposure time can be controlled by clicking the ExposureTime increase or decrease on the screen, and the exposure time can also be adjusted through the physical buttons of the equipment head.
User Interface Canis014D07 User Manual 30
Service Information 6 Service Information 6.1 Service Life The estimated product lifetime is up to 7 years under appropriate regular inspection and maintenance. NOTE The product life is decided by that of the equipment. For other replaceable parts, their service life will not affect the life cycle of the whole product. Main parts (parts required to maintain the function of the product) of this product will be stocked for 5 years after discontinuance of production for repairing. 6.
Service Information For the maintenance and overhaul involving the disassembly of the equipment enclosure, contact qualified service engineers. Please contact iRay’s Customer Service Department or your product distributors. ! WARNING 6.
Service Information CS email: service@iraygroup.com Website: www.iraygroup.com 6.6 Factory: Address: Factory Site iRay Imaging Technology (Haining) Limited 3rd floor, Building 1, No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.
Maunfacturer: iRay Imaging Technology (Haining) Limited Address: No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China Tel: +86-512-53690872 Fax: +86-512-53690872 Website: www.iraygroup.
