Hologic Trident - Compliance; Label Locations

Trident User Guide
Chapter 2: General Information
MAN-02098 Revision 008 Page 9
2.5 Compliance
This section describes the system compliance requirements and the responsibilities of the
manufacturer.
2.5.1 Compliance Requirements
The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
• The equipment is used according to the User Guide.
• The assembly operations, extensions, adjustments, changes, or repairs are performed
only by authorized persons.
• The network and communication equipment must be installed to meet IEC Standards.
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.
2.5.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
• UL 61010-1, 2nd Edition, 2005-07-22 (Electrical Equipment for Measurement, Control,
and Laboratory Use; Part 1: General Requirements)
• CAN/CSA-C22.2 No. 61010-1, 2nd Edition, 2004-07, (Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 1: General Requirements)
• IEC 61010-1:2001, 2nd Edition, and IEC 61010-1:2010, 3rd Edition.