Equipment Classification; Non-Medical Equipment - AGFA DR 14s User Manual

14 | DR 14s | 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
Applied Parts
Water ingress
Flammable anesthet-
ics
Operation
Estimated product
life (if regularly serv-
iced and maintained
according to Agfa in-
structions)

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
0350B EN 20190319 1349 *
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.
The DR Detector tube side is an applied part.
IP43
Protection against spraying water.
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.
Continuous operation.
Up to ten (10) years
The minimal total dose that the panel shall absorb
during its lifetime is 100 Gy at RQA5
WARNING:
Do not use non-medical equipment in the patient's vicinity.