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

12 | DX-D 40C, DX-D 40G | Introduction to the DR Detector

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
equipment
Type B
equipment
Water ingress
Flammable
anesthetics
Operation
Applied Parts

Non-medical equipment

Following components are classified as non-medical equipment:
• DR Detector battery charger
• System Control Unit
• Workstation
0290A EN 20140626 1622
Internally powered
A Type B piece of equipment is one that provides a
particular degree of protection against electric shock
particularly regarding allowable leakage current and
reliability of the protective earth protection.
This device does not have protection against ingress of
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.