Selenia User Guide
Chapter 2—General Information
MAN-03270 Revision 003 15
Caution:
The use of unauthorized accessories and cables can result
in increased emissions or decreased immunity. To keep
the isolation quality for the system, attach only approved
Hologic accessories or options to the system.
Caution:
The Medical Electrical (ME) Equipment or ME System
should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, make
sure that the ME Equipment or ME System operates
correctly in this configuration.
Caution:
This system is intended for use by healthcare
professionals only. This system may cause radio
interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation
measures, such as re-orienting
or relocating the equipment
or shielding the location.
Caution:
Changes or modifications not expressly approved by
Hologic could void your authority to operate the
equipment.
2.6.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
• CAN/CSA - ISO 13485-03 Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition,
2003-07-15)
• CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005,
third edition, 2005-12), includes Corrigendum 1:2011; also CAN/CSA C22.2 NO.
601.1-M90 (R2005) Medical Electrical Equipment Part 1: General Requirements for
Safety
• EN 60601-1:2006 Medical Electrical Equipment. General Requirements for Basic Safety
and Essential Performance; also EN 60601-1:1990 +A1+A11+A12+A2+A13 Medical
Electrical Equipment—General Requirements for Safety
• FDA, 21 CFR [Parts 820, 900 and 1020]
• IEC 60601-1 Ed. 3.0:2005 Medical Electrical Equipment – Part 1: General Requirements
for Basic Safety and Essential Performance; also IEC 60601-1 Ed. 2.0:1988 +A1+A2:1995
Medical Electrical Equipment—General Requirements for Safety
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