Equipment Classification; Non-Medical Equipment - AGFA XD 14 User Manual

16 | XD 14, XD⁺14 | Introduction to the DR Detector

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
Degree of protection
against electrical shock
Degree of protection
against ingress of water
and dust
Flammable anesthetics
Operation
Applied Parts
Expected service life

Non-medical equipment

Following components are classified as non-medical equipment:
• System Control Unit (SCU)
• DR detector cradle
• DR detector battery charger
• Workstation
0430A EN 20210426 1355
Internally powered (wireless configuration)
Class I equipment (wired configuration)
Type B applied parts
IP67
(degrees of protection against ingress of water
and dust provided by enclosure)
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.
Continuous operation.
The DR detector tube side is an applied part.
Up to seven (7) years
(if regularly serviced and maintained according to
Agfa instructions)