Equipment Classification; Non-Medical Equipment - AGFA DX-D 60C User Manual

12 | DX-D 60C, DX-D 60G | Introduction to the DR Detector

Equipment Classification

Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, the DR Detector is classified as following.
Class I equip-
ment
Type B equip-
ment
Water ingress
Flammable
anesthetics
Operation
Applied Parts
Expected serv-
ice life

Non-medical equipment

Following components are classified as non-medical equipment:
• System Control Unit
• Workstation
0294B EN 20190221 1131
Equipment in which protection against electric shock does
not relay on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth reliabili-
ty always plug the main power cord into an earthed mains
power outlet.
A Type B piece of equipment is one that provides a particu-
lar degree of protection against electric shock particularly
regarding allowable leakage current and reliability of the
protective earth protection.
IP53
This device is protected against spraying water.
This device is not suitable for use in the presence of a flam-
mable anesthetic mixture with air, or in presence of a flam-
mable 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 in-
structions)