Equipment Classification - AGFA DR 100e User Manual

74 | DR 100e (Film/CR) | Product Information

Equipment Classification

Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:
Table 2: Equipment classification
Class I equip-
ment
Type B equip-
ment
Water ingress IPX0
Cleaning
Disinfection
Flammable
anesthetics
Operation
0360B EN 20181015 0853
Equipment in which protection against electric shock does
not relay on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth reliability
always plug the main power cord into an earthed mains
power outlet.
A Type B piece of equipment is one that provides a particular
degree of protection against electric shock particularly re-
garding allowable leakage current and reliability of the pro-
tective earth protection.
This device does not have protection against ingress of wa-
ter.
See section on cleaning and disinfecting.
See section on cleaning and disinfecting.
The equipment is not type AP or APG.
This device is not suitable for use in the presence of a flam-
mable anesthetic mixture with air, or in presence of a flam-
mable anesthetic mixture with oxygen or nitrous oxide.
Continuous operation with intermittent load.