Planar Dome E4c User Manual download pdf (Page 5)

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.”

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Planar Dome E4c User Manual Page 5