1 Introduction
2
GE Healthcare
86500-IMG rev 3
WARNING!
USE LIMITATION : External components: The use of accessories,
transducers, and cables other than those specified may result in
degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and/or
SYSTEM.
WARNING!
If you suspect any electro-magnetical interference affecting or caused by
the unit, call service. Portable and mobile RF communications equipment
can interfere with operation of the medical electrical equipment.
GE accepts no responsibility for safety, reliability or performance unless:
•
Assembly, calibration and repairs are performed by an GE-
authorized representative according to the corresponding Diamond
manuals.
•
Any modification, addition or deletion to this system is authorized
specifically by GE, in writing.
•
Electrical installation complies with the IEC regulations.
•
The system is used in accordance with the Operating Instructions.
Each Diamond unit has been tested for leakage radiation and the test
results are recorded in the final test protocol.
This device emits X-ray radiation for medical purposes. The Diamond X-
ray tube has a Molybdenum anode. X-rays are either Molybdenum-,
Rhodium- or Aluminum-filtered. The Minimum HVL is 0.3 mm Al@30kV
tube voltage without the compression paddle. Diamond is CE-marked in
accordance with MDD (93/42/EEC) and its design complies with IEC
60601-1. Diamond fulfills the EMC requirements of IEC 60601-1-2 2.ed.
The Diamond breast imaging unit is tested and certified according to UL/
CSA.
1.2
R
ADIATION
PROTECTION
As radiation is harmful to the human body, the radiation protection
regulations of individual countries must be complied with. The user must
have permission to use an x-ray device for mammography. Radiation
protection means should be used. Prior to examination, it is
recommended to make sure that the doctor knows if the patient is
pregnant. If someone has to be close to the patient, protective clothing
must be used.
The optional
radiation shield
must be used, or the unit must be operated
from a shielded control room (significant zone of occupancy is 2 meters).
During the exposure, visual and audible contact should be maintained
with the patient. The free-standing radiation shield can be positioned as
required in the X-ray room. An mammography accessory storage unit is
available as an option and may be placed behind the free-standing
radiation shield. Diamond with radiation protection is in accordance with
IEC 601-1-3:1994.
Fig 1.1.
Optional radiation
shield (34135-IMG)
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