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
IPX0
(The DR detector conforms to IPX3)
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
• DR Detector battery charger
• Wireless access point
• Network switch
• Workstation
• DR Generator Sync Box
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
14 | DR 10e, DR 14e, DR 17e | Introduction to the DR Detector
0370C EN 20200228 1449
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