Varex Imaging nexus DR, Руководство по безопасности

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1. Regulatory Information
Regulations
Review the following table for regulatory information that applies to this product.
Applicable standards & compliance
• FDA 510(k)
• ETL listed
• CAN/CSA C22.2 No. 60601-1
• IEC 60601-1, 60601-1-2, 62304, 62366
• ANSI/AAMI ES60601-1
This product conforms to the necessary IEC standards for patient safety and isolation as
shipped from the factory. The end user and/or the installer is responsible to ensure that when
connected, as a system with other devices, this product meets all the rules of IEC 60601-1.
EU Authorized Representative
ARAZY GROUP GmbH
The Squaire 12, Am Flughafen,
60549 Frankfurt am Main, Germany
germany@arazygroup.com
Swiss Authorized Representative
Arazy Group Swiss GmbH
Bruderholzallee 53
4059 Basel, Schweiz
swiss.ar@arazygroup.com
Australian Sponsor
Emergo Asia Pacific Pty Ltd
201 Sussex Street
Darling Park, Tower II, Level 20
Sydney, NSW 2000
Australia
Radiation Control for Health and Safety Act (RCHSA)
The Digital X-ray Imaging System meets the requirements of the Radiation Performance
Standards of 21 CFR Subchapter J, applicable Sections 21 CFR 1020.30, 1020.31 and
1020.32.
Any video monitors chosen for this application meet the requirements of the Radiation
Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1020.10.
Any optical disk storage devices (reader and writer) comply with Radiation Performance
Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1040.10.
2 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J