NDS Radiance Ultra 4K, Руководство пользователя

Страница: 7 / 32

Safety Information | 1
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 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 professional healthcare environments.
This product is designed to meet medical safety requirements for a patient vicinity device.
This product is a Class
I
medical device. 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 ISO and UL/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 ISO and UL/EN/IEC 60601-1 safety standards.
Installation of this product shall be carried out only by NDS authorized and trained personnel.
Intended Use and Contraindications
Intended Use
This product is intended for use in a medical environment to display high quality video and graphic images.
Contraindications
1. Do not use this product in the presence of flammable anesthetics mixture with air, oxygen or nitrous oxide.
2. To prevent fire or shock hazards, do not expose this product to rain or moisture.
3. No part of this product may come in contact with a patient. Never touch the product and a patient at the
same time.
4. This product is capable of displaying Radiology (PACS) images for reference only, and is not intended for
diagnostic use.
5. For mission critical applications, we strongly recommend that a replacement unit be immediately available.