CANON ELECTRON TUBES& DEVICES CO., LTD.

Instructions For Use
X-ray Tube Assembly: ROTANODE XRR series★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-IFU015-07_Rev.0

0.Scope

This document is provided to meet the requirements in Section 23.4 of Annex I and the related
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/EECand 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.
7. Storage /handling condition:
Environmental Limits
・Operating Limits / Shipping and Storage Limits
Refer to Table.1

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8. Sterilisation:
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 are intended to
be introduced into the human body via a body orifice or applied to the skin and that are absorbed by orlocally dispersed in the human body.
11.Intended purpose:
A component, rotating anode X-ray tube assembly that converts electric energy from the high voltage
generator of the X-ray radiography and/or fluoroscopy system to X-ray beam with the expected beamprofile and dose, is intended for diagnostic X-ray radiography and/or fluoroscopy system but is not intended
for mammography. It shall be installed in the X-ray radiography and/or fluoroscopy system.
12. Indications
X-ray tube assembly is intended for the following purposes.
Intended for diagnostic X-ray Radiography and/or Fluoroscopy 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 group changes 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 tumors,or remove blood clots or other blockages.

3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 system manufacturer 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.
22. Requirements for qualifications:Physicians, Radiographers, Radiological technologists, Dentists

23. About safe use of device:
This requirement is for X-ray system manufacturers.
24. Reuse processes:
No special processes are required for reuse.
25. About reusable or not:This device is reusable.

426. Combination device:
Documents are provided to X-ray system manufacturers regarding the connection and installation withhigh 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 Xray 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 the instructions forhandling the defect and failure in the instruction for use of the X-ray system manufacturers.

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28.2. External influences:
Use in accordance with “reasonably foreseeable external influences or environmental conditions,”
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 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 an integral partof 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.
29. Interaction with other substances:
It is not a device which intended to be inserted into the human body and absorbed by the human body orcomposed of a substance or combination of substances that are localized in the human body.
30. Implantable device:
This device is not implantable.

631. Warnings or precautions to be taken in order to facilitate the safe disposal of the device, its
accessories and the consumables used with it:○Lead Metal;
Lead metal is used inside some of the X-ray Tubes housing unit to protect against X-ray leakage. Leadpowder and vapor are highly toxic. Disposal of X-ray Tube and X-ray Tube Assembly should comply withall 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 applicablelaws and regulations. 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 systemmanufacturer) and the competent authority of the Member State in which the user / patient established.
35. IT security measures:This is not a device that incorporates electronic programmable systems, including software, or softwarethat are devices in themselves.
36. Implementation of seasoning and tube current adjustment.
In order to use "ROTANODE" for a long time, the seasoning before every day's start, adjust the tube
current and the cooling after every day's finish are recommendable.
In addition, when "ROTANODE" is used first after the installation or after the pause more than two weeks,
recommend the seasoning of "ROTANODE". Execute the seasoning when "ROTANODE" is unstable.

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

Shipping and Storage Limits
Nominal Focal Spot Value

Insulation
Oil

XRR-3331X

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-3332X

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-3334F

10 ~ 40°C

10 ~ 86%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-3336X

10 ~ 40°C

10 ~ 86%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-4631G

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-6634X

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-15 ~ 70°C

10 ~ 90%

50 ~ 106kPa

1.2 / 0.6

X

XRR-6652X

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-15 ~ 70°C

10 ~ 90%

50 ~ 106kPa

0.8 / 0.3

X

XRR-6653X

10 ~ 40°C

30 ~ 85%

70 ~ 106kPa-20 ~ 70°C

20 ~ 90%

50 ~ 106kPa

0.8 / 0.3

X-----------------------------------------------------------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.

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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
02024-03-01

Revised contents
Issued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 whichdeals CETD products sold via CANON MEDICAL COMPONENTS EUROPEB.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