Zeiss METROTOM Installation Instructions Manual - page 3
Installation Instructions
Page
3
1. Operation of X-ray devices
1.1
German X-ray Ordinance (RöV), Information on radiation protection
The following information refers to the operation of X-ray devices in the Federal Republic of Germany. In other
countries, the locally applicable regulations must be observed by the operator.
The METROTOM system fulfills the conditions of Annex 2, Item 3 of the RöV (X-ray Law); it thus complies with
the properties of a fully protected device.
Operation of the METROTOM must be approved in compliance with § 3 of the RöV.
In order to obtain an operating permit, the operator must do the following:
• Have the METROTOM inspected by an authorized independent expert for technical inspections of X-ray systems.
• Authorize a (local) radiation protection officer.
• Submit an application for a permit to operate the system to the supervisory authority far enough in advance of the
beginning of operation. The components of the permit application include the result of the inspection performed by
the above expert, the personal data of the radiation protection officer, proof of his technical qualification and autho-
rization, etc.) as well as detailed information on the radiation protection organization.
The supervisory authority can stipulate further conditions which must be fulfilled as a prerequisite for the notice of ap-
proval.
According to § 18 of the RöV, the METROTOM must be inspected by an authorized expert after 5 years of operation at
the latest (recurring inspections).
The responsible supervisory authority of the relevant state is usually the Trade Supervisory Authority, the Occupational
Health and Safety Administration or the Regional Board.
United states
The system conforms to 21 CFR 1020.40
Typically, an x-ray system must be registered with the appropriate state agency. This registration must occur prior to the
x-ray system being placed into service. Regulations may require initial and periodic inspections by a government agency
or a qualified vendor. In addition, the regulations may require the implementation of standardized operating procedures,
specialized training and posting of radiation exposure warnings and other special notices. Radiation safety requirements
differ significantly from one jurisdiction to another. It is the users' responsibility to ensure that the x-ray system is installed
and operated in compliance with all applicable governmental regulations. Failure to comply may result in substantial pen-
alties.
Other countries
In other countries, the national regulations regarding x-ray protection must be observed.
It is advisable to report a planned installation to the supervisory authority in due time, i.e. 2 to 3 weeks in ad-
vance.
Note:
Note: