Restrictions On Use - Carestream DRX-Revolution Safety And Regulatory Information Manual

Restrictions on Use

The user must make sure that any equipment used with the System does not
compromise the System patient contact rating.
The user is also responsible for safety and EMC compliance of any
non-Carestream Health recommended, installed, or supplied accessory
equipment.
The use of accessory equipment and/or hardware not complying with the
equivalent product safety and EMC requirements of this product may lead to a
reduced level of safety and/or EMC performance of the System.
Consideration relating to the choice of accessory equipment used with this
product shall include:
• Use of the accessory in the patient's vicinity.
• Evidence that the safety certification of the accessory has been performed
in accordance with applicable coordinated harmonized product safety
standards per IEC 60601-1-1.
• Evidence that applicable emission certification of the accessory has been
performed.
CAUTION
:
Observe all safety precautions recommended by the accessory
equipment manufacturer in the user documentation provided
with the equipment.
The hardware specified for use with the System has been selected, tested, and
verified by Carestream Health, Inc. to meet the intended applications. All
specified hardware meets applicable regulatory agency requirements for
those countries where it is offered for sale with respect to its intended
applications. Consult the user documentation included with the equipment for
specific information relating to product safety and EMC compliance.
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Safety and Regulatory Information
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