Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety, the DR Detector, including the battery pack, is classified as following.
Type of protection
against electrical shock
Internally powered (wireless configuration)
Class I equipment (wired configuration)
Degree of protection
against electrical shock
Type B applied parts
Degree of protection
against ingress of water
and dust
IP67
(degrees of protection against ingress of water
and dust provided by enclosure)
Flammable anesthetics This device is not suitable for use in the presence
of a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
Operation Continuous operation.
Applied Parts The DR detector tube side is an applied part.
Expected service life Up to seven (7) years
(if regularly serviced and maintained according to
Agfa instructions)
Non-medical equipment
Following components are classified as non-medical equipment:
• System Control Unit (SCU)
• DR detector cradle
• DR detector battery charger
• Workstation
16 | XD 14, XD⁺14 | Introduction to the DR Detector
0430A EN 20210426 1355
To Next Page
Loading...
