iRay Technology Canis014D07 Скачать руководство пользователя страница 14

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:

1

This device may not cause harmful interference.

2

This 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.

Содержание Canis014D07

Страница 1: ...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...

Страница 2: ......

Страница 3: ...ly 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 i...

Страница 4: ...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 sh...

Страница 5: ...omers 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...

Страница 6: ...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 Descript...

Страница 7: ...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 Inf...

Страница 8: ...ion 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 e...

Страница 9: ...ery 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 qualifie...

Страница 10: ...y 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 de...

Страница 11: ...efer 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 Haini...

Страница 12: ...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 P...

Страница 13: ...tability 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 requirem...

Страница 14: ...l 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 1 This device may not cause harmful interf...

Страница 15: ...he 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 w...

Страница 16: ...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 mobi...

Страница 17: ...nfirmed 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...

Страница 18: ...ponent 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 syste...

Страница 19: ...e 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...

Страница 20: ...ations 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...

Страница 21: ...180 5240MHz 5745 5825MHz Data Transmission Power 13dBm Typ 802 11a 13 5dBm Typ 802 11b 15dBm Typ 802 11g 15dBm Typ 802 11n HT20 14dBm Typ 802 11n HT40 13dBm Typ 802 11ac Wireless Modulation 11b DSSS D...

Страница 22: ...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 33 5 1 0 50 0 1 0 POWER LED Specifications Item Specification...

Страница 23: ...e 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 0C 10...

Страница 24: ...to tooth position and age and display the status related to exposure services Image view page View images and perform related operations on images Setting page Account settings function settings netw...

Страница 25: ...urrent patient s medical record Delete the selected medical record of the selected patient 2 Patient based search Enter the keyword pinyin and click to search to match the information in the database...

Страница 26: ...dified 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...

Страница 27: ...d pictures to confirm whether they are qualified Delete and re shoot the tooth position that do not meet the requirements You can save the default parameters according to your needs and the default pa...

Страница 28: ...el of the selected image The acquired images can be exported to the PC via a data cable Save the image to the local supporting jpg raw dicom three formats Patient information Display patient ID number...

Страница 29: ...is the processed image 5 6 Setting Page This page is mainly used to set account function network sensor and application connection mode General User s Functions Button Description Jump to the Android...

Страница 30: ...ord 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 use...

Страница 31: ...pose exposure When certain conditions are met for battery voltage power tube temperature time interval and detector status exposure can be performed During exposure you will hear a buzzer sound and th...

Страница 32: ...User Interface Canis014D07 User Manual 30...

Страница 33: ...tenance be carried out by the qualified maintenance personnel Item Operation Frequency Pre startup check Before operation check if the equipment is clean and ready for use Daily Post shutdown check Af...

Страница 34: ...n the surface turns dry WARNING The equipment must be powered off before disinfection and cleaning the equipment Disposable cloth or wipe should be used instead of reusable one 6 4 Troubleshooting If...

Страница 35: ...Manual CS email service iraygroup com Website www iraygroup com 6 6 Factory Site Factory iRay Imaging Technology Haining Limited Address 3rd floor Building 1 No 2 Caohejing RD Haining 314499 Jiaxing...

Страница 36: ...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 com...

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