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
Internally powered
Type B equipment
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.
Applied Parts
The DR Detector tube side is an applied part.
Water ingress
IP43
Protection against spraying water.
Flammable anesthet-
ics
This device is not suitable for use in the presence of a
flammable anesthetic mixture with air, or in pres-
ence of a flammable anesthetic mixture with oxygen
or nitrous oxide.
Operation
Continuous operation.
Estimated product
life (if regularly serv-
iced and maintained
according to Agfa in-
structions)
Up to ten (10) years
The minimal total dose that the panel shall absorb
during its lifetime is 100 Gy at RQA5
Non-medical equipment
Following components are classified as non-medical equipment:
• DR Detector battery charger
• IR data communication unit
• Wireless access point
• Network switch
• Workstation
• DR Generator Sync Box
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
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| DR 10s | Introduction to the DR Detector
0351A EN 20190319 1349 *