CANON ELECTRON TUBES& DEVICES CO., LTD.

Instructions For Use
X-ray Flat Panel Imager★The information contained herein is presented only as a guide for the application of our products. No responsibility is assumed by anon Electron Tubes &Devices Co., Ltd. (CETD) for any infringements of patents or other rights of the third parties which may result from its use.
No license is granted by implication or otherwise under any patent or patent rights of CETD or others.
★The information contained herein may be changed without prior notice. It is therefore, advisable to contact to CETD before processing with the design ofequipment incorporating this product.

No. EEN-IFU018-01 2023-09-01 Rev.2

0.Scope

This document is provided to meet the requirements in Section 23.4 of Annex I and therelated sections ofREGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 5 April 2017 on medical devices,amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC)No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
and its subsequent amendments.
Objective areas and countries of this document are EEA, Switzerland and Turkey.
1. Device category:
X-ray Flat Panel Imager*So-called X-ray Flat Panel Detector (FPD)
2. Manufacturer name:
Canon Electron Tubes & Devices Co., Ltd.
3. Name:X-Ray FLAT PANEL IMAGER FDXA4343R
X-Ray FLAT PANEL IMAGER FDXA4343R-HD
X-Ray FLAT PANEL IMAGER FDX4343R

4. Registered place of business:
1385, Shimoishigami, Otawara-shi, Tochigi 324-8550, Japan
5. About medicinal substance, including a human blood or plasma derivative, ortissues or cells of animal origin, or their derivatives:
Not Applicable.
6. About CMR substances and endocrine-disrupting substances:
Not Applicable.

-2-7. Storage /handling condition:
・Under Operating:
FDXA4343R

FDXA4343R-HD

FDX4343R

Temperature(℃)

10~35

10~35

10~35

Humidity(%)

10~85

10~85

30~85

Pressure(kPa)

70~10670~10670~106

FDXA4343R

FDXA4343R-HD

FDX4343R

Temperature(℃)-20~70-20~70-15~55

Humidity(%)

10~90

10~90

10~90

Pressure(kPa)

50～10650～10650~106

・Under Shipping and Storage

8. Sterilisation:
Not Applicable.
9. Single use:
Not Applicable.
10. The overall qualitative composition and quantitative information;
Not Applicable.
11. Intended purpose:
A component, X-ray flat panel imager provides digital signals by detecting X-rays patternwhich pass through a patient body and reach its surface. It is intended for radiography but is
not intended for mammography and fluoroscopy applications. It is not intended for recordingof diagnostic images because this device does not have recording function of diagnosticimages. It shall be installed to an X-ray system.
It does not provide clinical image, nor function of controlling X-ray generator.
For medical diagnosis, it additionally requires image processing with application software tovisualize digital image.
12. Indications:This X-ray flat panel imager is intended for medical X-ray imaging, radiography.

-3-13. Contra-indications:
Not Applicable.
14. The patient target group or groups:
Not Applicable.
15.Intended users:
Physicians, Radiographers, Radiological Technologists
16. Clinical benefits:•Noninvasively and painlessly help to diagnose disease and monitor therapy;•Support medical and surgical treatment planning.
17. Links to EUDAMED:
Not Applicable
18. Performance characteristics;
FDXA4343R

FDXA4343R-HD

FDX4343R

Active Area(mm)426(H)×425(V)

426(H)×425(V)

430(H)×439(V)Pixel Matrix

3040(H)×3036(V)

3040(H)×3036(V)

3008(H)×3072(V)19. Corresponding software and accessories:
Not Applicable.

-4-20. Residual risks, contra-indications and side-effects:*In accordance with MDR Annex I, Sec 23.4(g),Residual risks;-If any malfunction occurs, contact the X-ray manufacturer and ask the X-ray manufacture toreplace it as necessary.
-The performance of this device gradually deteriorates with frequent use, so if anymalfunction occurs, contact the X-ray manufacturer, and ask the X-ray manufacture toreplace it as necessary.
-Be sure to observe the precautions on this technical data (TD: Technical data) in order tomaintain the EMC characteristics of this device. Also, please carry out inspection according
to the contents indicated in this technical data.
-The FPI does not have an applied part. Install the FPI not to contact or touch the patientsand operators.
-Do not drop the device. If dropped, it may be cause of malfunction.
This document describes the attention of equipment manufacturers and users to use safety
X-Ray FLAT PANEL IMAGER (hereafter called FPI). Please find the technical data sheet ofeach product and this document “SAFETY PRECAUTIONS AND WARNING” andunderstand these contents before using FPI.
21. About appropriate use of device:
This requirement is for X-ray system manufacturers.
22. Requirements for qualifications:Physicians, Radiographers, Radiological technologists, Dentists

23. About appropriate use of device:
This requirement is for X-ray system manufacturers.
24. Reuse processes:
Not Applicable.
25. About reusable or not:Not Applicable.

-5-26. Combination device:
Documents are provided to X-ray system manufacturers regarding the connection tointerface box, X-ray Control Unit and PC.
The user is not involved in this part.
27. Radiation:
The device does not emit radiation for medical purposes.

28. Warnings, precautions, contra- indications:28.1. Measures to be taken in the event of malfunction that may affect safety:
The X-ray flat panel imager may stop operating suddenly due to its life or unexpectedfailure.
If any defect was found in the X-ray flat panel imager, stop using it immediately andaccording to the instructions for handling the defect and failure described in the instruction
for use of the X-ray system manufacturer.
28.2 External influences:
To prevent device malfunction, do not use anything generates electromagnetic waves, which
are not related to its operation, in the environment where the X-ray flat panel imager isinstalled.
28.3 Affecting other equipment:
Notifying the manufacturer of X-ray system to evaluate electromagnetic interference.
28.4 Substance to be delivered:
It is not a device intended to administer medicinal products, tissues or cells of human oranimal origin, or their derivatives, or biological substances.
28.5 Medicinal substance or biological material:
The medicinal substances or biological materials are not incorporated into the device as anintegral part of the device.
28.6 CMR substances and endocrine-disrupting substances:
The substance is not included in the part (contact part) that may affect the user and patient.

-6-29. Interaction with other substances:
Not Applicable.
30. Implantable device:
Not Applicable.
31. Warnings or precautions to be taken in order to facilitate the safe disposal of thedevice, its accessories and the consumables used with it:
FPI has lead plate for X-ray shielding to prevent from lower image quality due to scatteringradiation. The lead powder or vapor is harmful for human health. Dispose the scrapped
products according to the requirement of local regulation.
32. Use by lay persons:
Not Applicable.
33. About Article 1(2) of MDR:
Not Applicable.
34.Report any serious incident:
If a serious incident occurs in relation to the device, it should be reported to the manufacturer(X-ray system manufacturer) and the competent authority of the Member State in which theuser / patient established.
35. IT security measures:This device is controlled by X-ray system. Therefore, X-ray system side shall take appropriate
actions to maintain necessary security level by consistent risk management such as systemsetting, network security and system management, etc.. Otherwise, it may cause security
problems (illegal operation, hacking, data manipulation, information leaking, etc…)-7-

CANON ELECTRON TUBES & DEVICES CO., LTD.
Marketing Engineering Department, Sales Division1385, SHIMOISHIGAMI, OTAWARA-SHI, TOCHIGI 324-8550, JAPAN
PHONE +81-287-26-6666, FAX +81-287-26-6060
https://etd.canon

EU REPRESENTATIVECANON MEDICAL COMPONENTS EUROPE B.V.
BOVENKERKERWEG 59, 1185 XB AMSTELVEEN, THE NETHERLANDSPHONE +31-20-399-9087

Marketing Engineering Department, Sales Division1385, Shimoishigami, Otawara-shi, Tochigi 324-8550, Japan
Tel +81-287-26-6666
Fax +81-287-26-6060
https://etd.canon.

Revision History
Rev.

Date

Revised contents

02022-05-12

Issued12023-03-01

Revised・Change of country name of SUMITOMO DEUTSCHLAND GMBH・Add EU Importers

22023-09-01

Revised・Change EU REPRESENTATIVE and EU Importers

EU IMPORTERS on EU Medical Device Regulation:
Multiple EU IMPORTERs are handling CETD products. For more information about
the relations between the CETD products and EU IMPORTERs, please contact CETD.

・CANON MEDICAL COMPONENTS EUROPE B.V. is the importer which
deals CETD products sold via CANON MEDICAL COMPONENTSEUROPE B.V.
Contact information
ADDRESS: BOVENKERKERWEG 59, 1185 XB AMSTELVEEN,THE NETHERLANDSPHONE: +31-20-399-9087

・SUMITOMO DEUTSCHLAND GMBH is the importer which deals CETD
products sold via SUMITOMO DEUTSCHLAND GMBH.
Contact information
ADDRESS: SCHWANNSTRASSE 10, 40476 DUSSELDORF, GERMANY
PHONE: +49-211-4570-0, FAX +49 -211-4570-236