Product Information | v
Intended use
The Dome E4c display is an AMLCD unit designed for viewing medical
X-ray images. This unit should not be used near patients and should
be kept outside of 1.83 m perimeter and 2.29 m vertical.
This device must not be used in primary image diagnosis in
mammography.
CAUTION: Federal law restricts this device to sale by or on the order of
a medical practitioner.
Safety precautions
External equipment intended for connection to signal input, signal
output, or other connectors must comply with the relevant IEC
standard (EN/IEC 60601-1 series for medical electrical equipment).
All such combinations (systems) must comply with the standard IEC
60601-1-1,
Safety requirements for medical electrical systems.
Equipment not complying to IEC 60601 must be kept outside the
patient environment, as defined in the standard as at least 1.5 meters
from the patient or the patient support.
Any person who connects external equipment to signal input, signal
output, or other connectors has formed a system and is therefore
responsible for the system to comply with the requirements of IEC
60601-1-1. If in doubt, speak with a qualified technician.
GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN
EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTABLE
MARKED “HOSPITAL ONLY” OR “HOSPITAL GRADE.”
mx4.book Page v Wednesday, August 9, 2006 3:03 PM
