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
Internally powered
Type B equip-
ment
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.
Water ingress
IP53
This device is protected against spraying water.
Flammable an-
esthetics
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.
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 45C, DX-D 45G | Introduction to the DR Detector |
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0292B EN 20190401 1627