Equipment Classification; Non-Medical Equipment - AGFA DX-D 40C User Manual

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 protec-
tion agains elec-
trical shock
Type B equip-
ment
Water ingress
Flammable anes-
thetics
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 40C, DX-D 40G | Introduction to the DR Detector | 15
Internally powered (wireless configuration)
Class I equipment (wired configuration)
A Type B piece of equipment is one that provides a par-
ticular degree of protection against electric shock partic-
ularly regarding allowable leakage current and reliability
of the protective earth protection.
IPX3
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
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)
0290B EN 20190401 1627