Cdrh Compliance; Classification In Accordance With Iec 60601-1; Iec/En 60601-1-3 Compliance - Carestream DRX-Revolution Safety And Regulatory Information Manual

Safety and Regulatory Information

CDRH Compliance

Classification in
Accordance with
IEC 60601-1
Type of protection against electrical shock
Degree of protection against electrical shock
Degree of protection against ingress of water
Mode of operation
Flammable anesthetics
IEC/EN 60601-1-3
Compliance
Electrical Rating
DRX-Revolution Mobile X-ray System
DRX-Revolution Grid Holder
CARESTREAM DRX-1/DRX-1C System Detector
1-9
The X-ray System complies with Department of Health and Human Services
radiation performance standards per Title 21 CFR, Chapter 1, Subchapter J.
Class I equipment/Internally powered
Type B protection against electrical shock
Ordinary protection
Continuous operation with intermittent loading
Not suitable for use in the presence of flammable anesthetics
or a mixture of flammable anesthetics with air or oxygen or
nitrous oxide
The System is manufactured with radiation protection in accordance with
IEC/EN 60601-1-3:1994.
Voltage: 100/120/200/240/ VAC
Current: 4.4/12.0/7.2/6.0 A
Frequency: 50/60 Hz
Voltage: 3.2 V (dc)
Current: 1.5 A
Voltage: 12–1 8 V(dc)
Current: 3.0 A
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