NDS VIMA User Manual - Safety Information
Safety Information | iii
Safety Information
Warnings and Cautions
This symbol alerts the user that important information regarding the installation and/or operation of
this equipment follows. Information preceded by this symbol should be read carefully in order to avoid
damage to the equipment.
This symbol warns the user that un-insulated voltage within the unit may have sufficient magnitude to
cause electrical shock. It is dangerous to make contact with any part inside the unit. To reduce the risk of
electric shock, DO NOT remove cover (or back).
Note: There are no user serviceable parts inside. Refer servicing to qualified service personnel.
This symbol cautions the user that important information regarding the operation and/or maintenance
of this equipment has been included. Information preceded by this symbol should be read carefully to
avoid damage to the equipment.
This symbol appears next to the Potential Equalization Conductor on the VIMA.
This symbol denotes the manufacturer.
This symbol denotes the manufacturer’s European Community representative.
Safety Compliance
This product is T.U.V. approved with respect to electric shock, fire and mechanical hazards only in
accordance with CAN/CSA C22.2 No. 60601-1 and ANSI/AAMI ES60601-1.
Safety Compliance
This product meets the requirements of EN60601-1 so as to conform to the Medical Device Directive
93/42/EEC and 2007/47/EC (general safety information).
This product is intended only for use by healthcare professionals in secured and compliant environments. The
healthcare professionals using this product assume full responsibility for compliance with all applicable laws and
regulations, including but not limited to HIPAA and GDPR.
This product is designed to meet medical safety requirements for a patient vicinity device.
This product is a Class I medical device according to M.D.D. in Europe. No modifications are allowed.
This product is intended for continuous operation.
System Safety Requirements
External equipment connected to the signal input/output or other connectors of this product for use in a patient
environment must comply with the requirements of ANSI/AAMI ES/EN/IEC 60601-1 safety standards. A person
who connects such equipment to this product has by definition formed a system, and is responsible for
compliance of that system to the same ANSI/AAMI ES/EN/IEC 60601-1 safety standards.
NDS recommends that VIMA installation be conducted by qualified personnel.
Power Requirements
Model
Electrical Rating
VIMA Video Manager and Recorder
2 to 4A
VIMA Video Manager
2 to 4A
VIMA Video Recorder
1.25 to 2.5A
AC Input
100 - 240 Volts, 50 to 60 Hz