MOBILE RADIOGRAPHIC UNITS

Primary DI

42624007200490

Basic UDI-DI Code

426240072DelftOneVU

Reference

DelftOne

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

Not Intended For Eu Market

The DelftOne is a portable X-ray system that can be deployed in almost any venue, room or even under a tent. Local radiation safety rules need to be followed to obtain high-quality images with the least amount of radiation (ALARA principle).

The DelftOne is a portable X-ray system that can be deployed in almost any venue, room or even under a tent. Local radiation safety rules need to be followed to obtain high-quality images with the least amount of radiation (ALARA principle). Because of its nature, there is no ‘standard’ setup for the DelftOne the setup always depends on the venue used, amount of space, patient flow, etc. Some considerations for a correct use are: • Patient flow; Where do patients enter/exit the room? • X-ray beam direction; Where does the primary beam point to? This might be a trade-off with the patient flow. • Radiographer area; What is a safe distance for the radiographer? Is additional lead shielding available? • Imaging distance; What is the maximum distance between the X-ray and detector stand? The distance should be at least 120 cm.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).