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DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3
Generic Safety Directions for HealthCare Imaging Products
Page 21 of
28
•
The device complies with the EN 60601-1, 2006 standard for Information Technology.
This means that, although it is absolutely safe, patients may not come in direct contact
with the equipment. Therefore the operator console must be placed outside a radius
of 1.5 m around the patient.
Patient environment
1.5m
R = 1.5m
1.5m
•
This device should be installed behind the institution firewall for network security and
anti-virus protection. No ongoing computer virus protection or network security for this
medical device is provided (e.g. a computer firewall). Network security and anti-virus
provisions are the ongoing responsibility of the user or institution.
Fixing equipment at the wall or floor:
Warning:
Unknown composition of wall or floor structure: Risk of injury or damage:
Hospital management is responsible for the position, location and fixing of all equipment.
Floor load:
CAUTION:
Heavy device may damage the floor covering.
Make sure that the floor covering is solid enough to stand the weight of the device.
Fixing equipment at the ceiling:
CAUTION:
Ceiling construction may be inadequate for fixing of equipment: Risk of injury or
damage:
Hospital management is responsible for the position, location and fixing of all equipment.
07-2009
Agfa Company Confidential
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