Important information about the system, Intended use of the raysafe i2 system – RaySafe i2 System User Manual

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RaySafe i2 System User Manual – Important information About the system

IMpoRtAnt InfoRMAtIon ABoUt tHe SySteM

Intended USe of tHe RAySAfe I2 SySteM

this product is intended to be installed, used and operated only in accordance with the safety procedures
and operating instructions given in these Instructions for Use for the purpose for which it was designed. the
purpose for which the product is intended is given below. However, nothing stated in these Instructions for Use
reduces users’ responsibilities for sound clinical judgment and best clinical procedure.

the RaySafe i2 System is an electronic X-ray dose monitoring system. the intended use is to improve
the awareness of people who work with or are in the presence of X-ray imaging equipment, about their
occupational dose (also known as staff dose).

the awareness focuses on:

• a graphical visualization of the real-time staff dose rate while working with X-ray equipment in examination

rooms during medical procedures;

• instant access to historical staff dose for reporting and analysis purposes.

the benefits of the RaySafe i2 System are to:

• make people aware of their received staff dose during clinical work with X-ray imaging equipment;

• instantly visualize the result of reducing measures of occupational dose by, for example, changing a

person’s position in the examination room.

the RaySafe i2 System may not be used as a legal staff dose recording solution. the RaySafe i2 System is not
intended for patient use.

NOTE

Do not expose the dosimeters in direct X-ray beam. They are designed to be exposed to
scattered radiation only.

NOTE

The dose manager, dose viewer, cradle and dosimeter rack are not intended to be used inside
examination rooms.

NOTE

The RaySafe i2 product is not a replacement for legal dosimeters.

Installation, use and operation of this RaySafe i2 System is subject to the law in the jurisdiction(s) in which the
RaySafe i2 System is being used. operators must only install, use and operate the RaySafe i2 System in such
ways as do not conflict with applicable laws, or regulations, which have the force of law.

Uses of the X-ray system for purposes other than those intended and Uses of the RaySafe i2 System for
purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use

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