Equipment Classification; Non-Medical Equipment - AGFA DX-D 45C User Manual

Equipment Classification

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

Non-medical equipment

Following components are classified as non-medical equipment:
• DR Detector battery charger
• System Control Unit
• Workstation
DX-D 45C, DX-D 45G | Introduction to the DR Detector | 15
Internally powered
A Type B piece of equipment is one that provides a partic-
ular degree of protection against electric shock particular-
ly 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
flammable anesthetic mixture with air, or in presence of a
flammable anesthetic mixture with oxygen or nitrous ox-
ide.
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)
0292B EN 20190401 1627