DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.
Edition 1, Revision 5
Generic Safety Directions for HealthCare Imaging Products
Page 24 of 30
Ground potential differences:
CAUTION:
To comply with ISO 60601-1 (annex I) all computers and peripherals must be
connected to the same power source.
INSTRUCTION:
Always connect the associated monitor to the same uninterruptible power source as
the PC.
When different combinations of equipment are used in various medical environments
a potential difference (V) can exist between the protective earths in different localities.
If the protective earthing fails this potential difference can cause a hazard for the
operator or for the patient.
Performing the electrical test according to national regulations before putting the
equipment into service:
WARNING:
Improper ground connections or too high leakage current may lead to electric shocks.
After installation, before putting the equipment into service, inform the responsible
organization* about the necessity of the electrical test according to national
regulations.
If specific national regulations do not exist: It is recommended to perform the
electrical test according to IEC 62353.
Make sure, that all grounding connections are present.
*Responsible Organization:
Entity accountable for the use and maintenance of a medical equipment or a medical equipment system. The
accountable entity can be, for example, a hospital or an individual clinician.
NOTE:
Refer to the Agfa HealthCare Library for system specific IEC 62353 test documents.
04-2014
Agfa Company Confidential