CANON ELECTRON TUBES& DEVICES CO., LTD.

Instructions For Use
X-ray Tube Assembly: CXB series for CT★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-IFU015-01_Rev.7

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 Tube Assembly

2. Manufacturer name:
Canon Electron Tubes & Devices Co., Ltd.

3. Model:Refer to Table.1

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.

- 2 -7. Storage /handling condition:
Environmental Limits
・Operating Limits: Refer to Table.1
・Shipping and Storage Limits: Refer to Table.1

8. Sterilization:
This device is not intended to be sterilized.

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, rotating anode X-ray tube assembly that converts electric energy from the highvoltage generator of the X-ray CT system to X-ray beam with the expected beam profile anddose, is intended for diagnostic X-ray CT system but is not intended for mammography. It
shall be installed in the X-ray CT system.

12. Indications
X-ray tube assembly is intended for the following purposes.
Intended for diagnostic X-ray CT system.

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.

- 3 -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 tumors, 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;
Nominal Focus Spot Value: Refer to Table.1

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 system manufacturer and ask the X-ray systemmanufacturer to replace it as necessary.
- This device might be broken with applying just one over rated shot.

- The leakage radiation from the X-ray source are regulated legally.
- The X-ray system manufacturer is required to check the conformity with the requirement of
the local regulations.

21. About appropriate use of device:
This requirement is for X-ray system manufacturers.

- 4 -22. Requirements for qualifications:Physicians, Radiographers, Radiological technologists, Dentists

23. About appropriate use of device:
Reuse process is not required. Because this device is installed inside of the CT system.

24. Reuse processes:
No special processes are required for reuse.

25. About reusable or not:This device is reusable.

26. Combination device:
Documents are provided to X-ray system manufacturers regarding the connection andinstallation with high voltage generator, anode drive power (in case of rotating anode type),
starter (in case of rotating anode type), tube container (if not included), and heat exchanger(if you have a heat exchanger) in the X-ray system, and electrical / mechanical ratings.
The user is not involved in this part.

27. Radiation:・Type of radiation: X-ray・Nature: X-rays that can be acceptable through the human body.

・Intensity: High intensity X-ray for diagnostic purposes (not for treatment)

・Distribution: X-ray distribution covering the patient's body parts for diagnosis.

・Means of protecting : Protection against the radiation in accordance with IEC60601-1-3

28. Warnings, precautions, contra- indications:28.1. Measures to be taken in the event of malfunction that may affect safety:If any defect was found in the X-ray tube, stop using it immediately and according to theinstructions for handling the defect and failure in the instruction for use of the X-ray systemmanufacturer.

- 5 -28.2. External influences:
Use in accordance with “reasonably foreseeable external influences or environmentalconditions,” described in the instruction for use of the X-ray system manufacturer.

28.3. Affecting other equipment:
Use in accordance with description in the instruction for use of X-ray system manufacturer
to be taken as regards of the risks of interference posed by the reasonably foreseeable
presence of the device during specific diagnostic investigations, evaluations, or monitoringof therapeutic treatment or other procedures such as electromagnetic interference emitted
by the device affecting other equipment.

28.4. Substance to be delivered:
It is not a device intended to administer medicinal products, tissues or cells of human or
animal 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:
This device is not an implantable device.

- 6 -31. Warnings or precautions to be taken in order to facilitate the safe disposal of thedevice, its accessories and the consumables used with it:○Beryllium metal(Be);Some of the X-ray radiation ports of X-ray Tube Assemblies are made of the Beryllium metal(Be). Beryllium is not toxic under normal conditions (metal), but it is very toxic in powder orvapor form. If the powder or vapor contacts the skin, it may produce eruptions, ulcers orinterfere with wound healing. Furthermore, breathing the powder or vapor can result inserious personal injury or death. To prevent these toxic effects, it is strictly prohibited to cut,
grind, or polish beryllium, to wipe it with chemicals, or to burn it which produce powder orvapor. If the X-ray radiation port is broken during handling, collect all the fragments of theBeryllium metal and the disposal of them should complies with all applicable laws andregulations. Dispose the scrapped products according to the requirement of local regulation.

○Lead Metal;
Lead metal is used inside some of the X-ray Tubes housing unit to protect against X-rayleakage. Lead powder and vapor are highly toxic. Disposal of X-ray Tube and X-ray Tube
Assembly should comply with all applicable laws and regulations.
Dispose the scrapped products according to the requirement of local regulation.

○Insulation Oil
Insulation oil is used to ensure electric insulation in X-ray Tube Assembly. Insulation oil is
toxic if ingested. If insulation oil leaks from the X-ray tube assembly, disposal of the oil should
comply with all applicable laws and regulations. Dispose the scrapped products according tothe requirement of local regulation. (Refer to Table.1)○Liquid Metal;
Some of the Rotating X-ray Tubes and X-ray Tube Assembly are to be used liquid metal(gallium, indium, and tin alloy) for their rotation mechanism. These metals are toxic if ingested
or absorbed through the skin. Never burn the X-ray tube because toxic vapors will be
produced. Do not allow the liquid metal to come into contact with the skin. Disposal of themshould comply with all applicable laws and regulations. Dispose the scrapped products
according to the requirement of local regulation.

- 7 -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.

36. Implementation of seasoning, getter activation and tube current adjustment.
If the electric discharge phenomenon of the X-ray tube device has confirmed after long-term
use, perform seasoning, getter activation, and tube current adjustment.
In addition, it should be done periodically once within 3 months according to the usage
conditions to use the X-ray tube device for a long time without any failure.

- 8 -Table. 1: List of model and reference data
Operating Limits

Shipping and Storage Limits
Nominal Focal Spot Value

Insulation
Oil

- 9 -

CXB-200F

18 ~ 45°C

30 ~ 80%

70 ~ 106kPa-20 ~ 75°C

20 ~ 90%

50 ~ 106kPa

1.7 x 1.7 / 1.1 x 1.3

X

CXB-400C

18 ~ 45°C

30 ~ 80%

70 ~ 106kPa-20 ~ 75°C

20 ~ 90%

50 ~ 106kPa

1.4 x 1.4 / 0.9 x 0.7

X

CXB-500B

18 ~ 45°C

30 ~ 80%

70 ~ 106kPa-20 ~ 75°C

20 ~ 90%

50 ~ 106kPa

1.4 x 1.4 / 0.9 x 0.7

X

CXB-500C

18 ~ 45°C

30 ~ 80%

70 ~ 106kPa-20 ~ 75°C

20 ~ 90%

50 ~ 106kPa

1.4 x 1.4 / 0.9 x 0.7

X

CXB-750U

16 ~ 40°C

40 ~ 80%

70 ~ 106kPa-20 ~ 70°C

10 ~ 90%

50 ~ 106kPa

1.6 x 1.4 / 1.0 x 1.4 / 0.8 x 1.3
0.6 x 1.3 / 1.1 x 0.8 / 0.6 x 0.6
0.4 x 0.5-

CXB-750V

16 ~ 40°C

40 ~ 80%

70 ~ 106kPa-20 ~ 70°C

10 ~ 90%

50 ~ 106kPa

1.6 x 1.5 / 1.0 x 0.8----------------------------------------------------------------------------------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 HistoryRev.
Date0
2020-03-18
12021-01-22
22021-08-2732022-06-03

4567

2022-11-10
2023-03-01
2023-04-01
2023-10-01

Revised contents
IssuedRevised(Reflect to Notified Body Feedback)Revised(Reflect to Notified Body Feedback)Revised(Country name of AR is unified to EUDAMED expression)
Revised
Revised (Added model)
Revised (Added importer, Error correction)
Revised (Added models, EU representative changed)

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