Safety and Regulatory Information
Regulatory
Service Manual xxiii
Regulatory
GE Healthcare has declared that this product conforms with the European Council Directive 93/42/EEC
Medical Device Directive when it is used in accordance with the instructions provided in this Manual.
Standards
This device is designed to meet requirements of:
• ANSI/AAMI ES60601-1
• CSA C22.2 #60601-1
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-19
• IEC 60601-2-21
• 2002/96/EC WEEE directive
• 21 CFR CH-1 Section 1020.30 (n)
• ISO 19054 with an exception claim to clause 5.2.7.2. Slight deformation of rail occurs after application
of 500N to wide surface of DIN rail.
User Responsibility
This Product will perform in conformity with the description thereof contained in this manual and
accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance
with the instructions provided. This Product must be checked periodically. A defective Product should not be
used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced
immediately. Should such repair or replacement become necessary, GE Healthcare recommends that a
telephone or written request for service advice be made to the nearest GE Healthcare Regional Service
Center. This Product or any of its parts should not be repaired other than in accordance with written
instructions provided by GE Healthcare and by GE Healthcare trained personnel. The Product must not be
altered without GE Healthcare’s prior written approval. The user of this Product shall have the sole
responsibility for any malfunction that results from improper use, faulty maintenance, improper repair,
damage, or alteration by anyone other than GE Healthcare.
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