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Generic Safety Directions
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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 13 of 28
10 Connections to other Equipment
Agfa HealthCare equipment must only be used in combination with other Agfa HealthCare
equipment or components if these are expressly recognized by Agfa HealthCare as
compatible. A list of such equipment and components is available from Agfa HealthCare
service on request.
Changes or additions to the equipment must only be carried out by persons authorized to
do so by Agfa HealthCare. Such changes must comply with best engineering practice and
all applicable laws and regulations that have the force of law within the jurisdiction of the
hospital.
The Agfa HealthCare products are designed to communicate with other devices in the
hospital network using DICOM protocols.
Connections to other equipment:
Warning:
Accessory equipment not complying with the safety requirements of this product
may lead to a safety hazard.
INSTRUCTION:
Consult the Technical Documentation before making any connections to other equipment.
Consideration relating to the choice of accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity.
• Evidence that the safety certification of the accessory equipment has been performed
in accordance with the appropriate IEC 60601-1 and IEC 60601-1-1 harmonized
national standard.
In addition all configurations must comply with the medical electrical systems standard IEC
60601-1-1. The party that makes the connections acts as system Configurer and is
responsible for complying with the systems standard.
If required, contact your local service organization.
07-2009 Agfa Company Confidential
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