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
Internally powered (wireless configuration)
Class I equipment (wired configuration)
Type B equip-
ment
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.
Water ingress
IPX3
This device is protected against spraying water.
Flammable anes-
thetics
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:
• DR Detector battery charger
• System Control Unit
• Workstation
DX-D 40C, DX-D 40G | Introduction to the DR Detector |
15
0290B EN 20190401 1627