CANON ELECTRON TUBES& DEVICES CO., LTD.

Instructions For Use
X-ray Image Intensifier★The information contained herein is presented only as a guide for the application of our products. No responsibility is assumed by Canon 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-IFU019-01_Rev.1

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. CETD Device Category
X-ray Image Intensifier
2. Manufacturer name
Canon Electron Tubes & Devices Co., Ltd.
3. Name:X-ray Image Intensifier E5759HD-P1
X-ray Image Intensifier E5764HD-P3
X-ray Image Intensifier E5764SD-P1A
X-ray Image Intensifier E5764SD-P3
X-ray Image Intensifier E5764SD-P3A
X-ray Image Intensifier E5764SD-P4A
X-ray Image Intensifier E5764SD-P6A
X-ray Image Intensifier E5796SD-H1
X-ray Image Intensifier E5796SD-P10A
X-ray Image Intensifier E5796SD-P11A
X-ray Image Intensifier E5796SD-P1A
X-ray Image Intensifier E5796SD-P2A
X-ray Image Intensifier E5796SD-P7A
X-ray Image Intensifier E5804SD-P3
X-ray Image Intensifier E5830SD-P4
X-ray Image Intensifier E5830SD-H5
X-ray Image Intensifier E5830SD-H6
X-ray Image Intensifier E5830SD-H7
X-ray Image Intensifier E5830SD-P10A

X-ray Image Intensifier E5830SD-P11A
X-ray Image Intensifier E5830SD-P1A
X-ray Image Intensifier E5830SD-P3A
X-ray Image Intensifier E5830SD-P4A
X-ray Image Intensifier E5830SD-P6A
X-ray Image Intensifier E5830SD-P7
X-ray Image Intensifier E5830SD-P7A
X-ray Image Intensifier E5870SD-P1
X-ray Image Intensifier E5876SD-P1A
X-ray Image Intensifier E5876SD-P2A
X-ray Image Intensifier LIF-09
X-ray Image Intensifier RTP12302J-G10
X-ray Image Intensifier RTP12302J-G9
X-ray Image Intensifier RTP14301J-G1E
X-ray Image Intensifier RTP16301J-G1E
X-ray Image Intensifier RTP9206J-P9
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:
There is neither inclusion nor combination of the substances.
6. About CMR substances and endocrine-disrupting substances:
The substance is not included in the part (contact part) that may affect the user and patient.
Also, there is neither residual risk information nor preventive measures information.

7. Storage /handling condition:
・Under Operating:Temperature
Humidity
Pressure

5~40℃
30~85%
70~106kPa

・Under Shipping and Storage:
Temperature-15~45℃
Humidity
10~85%
Pressure
50～106kPa
8. Sterilisation:
This device is not intended to be sterilised.
9. Single use:
This device is not intended for single use.
10. The overall qualitative composition and quantitative information:
It is not a device that are composed of substances or of combinations of substances that areintended to be introduced into the human body via a body orifice or applied to the skin andthat are absorbed by or locally dispersed in the human body.
11. Intended purpose:
A component, X-ray image intensifier that converts X-ray pattern which pass through apatient body that reached input surface of image intensifier into corresponding light pattern.
It is intended for fluoroscopy systems but is not intended for mammography.
It is not intended for recording of diagnostic images because this device does not haverecording function. It shall be installed in an X-ray system with a TV camera to visualize
clinical images on a monitor.
12. Indications
This X-ray image intensifier is used for fluoroscopy of X-ray image diagnosis.
13. Contra-indications:
No contra-indications

14. The patient target group or groups:
It is impossible to identify patients using with this device because the target patient groupchanges with the X-ray systems in which the device is installed.
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 and•Guide medical personnel as they insert catheters, stents, or other devices inside the body,treat tumours, or remove blood clots or other blockages.
17. Links to EUDAMED
Not applicable since this device is not an implantable device or a class III device.
18. Performance characteristics:
Central Resolution [Lp/cm]
ModelN Mode

M1 Mode M2 Mode M3 ModeE5759HD-P148

E5764HD-P3485666

E5764SD-P1A

485666

E5764SD-P3485666

E5764SD-P3A

485666

E5764SD-P4A

485666

E5764SD-P6A

485666

E5796SD-H1465056

E5796SD-P10A

465056

E5796SD-P11A

465056

E5796SD-P1A

465056

E5796SD-P2A

465056

E5796SD-P7A

465056

E5804SD-P3

48

E5804SD-P4

48

E5830SD-H552

5868

E5830SD-H652

5868

E5830SD-H752

5868

E5830SD-P10A

525868

E5830SD-P11A

525868

E5830SD-P1A

525868

E5830SD-P3A525868

E5830SD-P4A

52

5868

E5830SD-P6A

525868

E5830SD-P7

525868

E5830SD-P7A

525868

E5870SD-P1

6877

E5876SD-P1A

46505665

E5876SD-P2A

46505665

LIF-09485666

RTP12302J-G10

5056

68

RTP12302J-G9505668

RTP14301J-G1E

424856

RTP16301J-G1E

40

4650

RTP9206J-P94860

19. Corresponding software and accessories:
This device has no corresponding software and accessories to be selected.
20. Residual risks, contra-indications and side-effects:
It is installed into X-ray system and radiates X-rays for diagnosis.
Therefore, the side effects of exposure occur.
Residual risks- The performance of this device gradually deteriorates with frequent use, so if any
malfunction occurs, contact the X-ray manufacturer and ask the X-ray manufacturer toreplace it as necessary.

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:
It is not a reusable device.
25. About reusable or not:
It is not a reusable device.
26. Combination device:
The X-ray system manufacturers or users determine the combination for other medical
devices to be combined with the X-ray system.
For connection to the power supply unit, documents are provided to the X-ray systemmanufacturer, and for connection to the camera, mechanical and optical information is alsoprovided.
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 image intensifier may stop operating suddenly due to its life or unexpected failure.
If any defect was found in the X-ray image intensifier, stop using it immediately and according
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:
X-ray image intensifiers may cause image distortion and resolution degradation whenaffected by an external magnetic field, so give consideration to reduce the effects ofexternal magnetism (including geomagnetism).

28.3. Affecting other equipment:
Notifying the X-ray system manufacturer 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 substances are not included in the part (contact part) that may affect the user and patient.
29. Interaction with other substances:
It is not a device which intended to be inserted into the human body and absorbed by thehuman body or composed of a substance or combination of substances that are localized in
the human body.
30. Implantable device:
It is not an implantable device.
31. Warnings or precautions to be taken in order to facilitate the safe disposal of thedevice, its accessories and the consumables used with it:
The housing of X-ray Image Intensifier (I.I.) has lead plate for the prevention of the X-rayleakage. 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:This device is not intended for use by lay persons.
33. About Article 1(2) of MDR:
This device is not covered by this Regulation pursuant to Article 1(2)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 is not a device that incorporates electronic programmable systems, including software,or software that are devices in themselves.

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.
Date0
2024-04-01
1
2024-05-16

Revised contents
IssuedAdd Name and Models

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 COMPONENTS EUROPE
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