8 Installation and set-up manual 208668
2. Pre-installation requirements CRANEX Novus e
2.2 The PC
• The PC to be used with the unit must be
installed in a location that meets all local and
national safety requirements with regards the
connection of a PC to an x-ray device.
• The connection of the unit to the PC must
meet EN60601-1 requirements. The PC must
be positioned at least 1.85 mm (73") away
from the unit.
• The use of
ACCESSORY equipment
not complying with the equivalent safety
requirements of this equipment may lead to a
reduced level of safety of the resulting system.
Consideration relating to the choice shall
include:
- Use of the accessory in the PATIENT
VICINITY
- Evidence that the safety certifi cation of
the ACCESSORY has been performed
in accordance to the appropriate
IEC 601-1 and/or IEC 601-1-1
harmonized national standard.
2.3 The dental imaging software
The dental imaging software, for example
SCANORA software or DIGORA for Windows
software (not in USA), that is installed in the PC
used with the unit must be MDD compliant .
2.4 Space requirements
When installing the unit make sure that:
- There is enough space at the front and sides
of the unit to allow patients to enter and exit
the unit easily. Patients in wheelchairs will
require more space than standing patients.
- The unit is positioned at least 1,85 m (73")
away from any non-medical electrical or
electromechanical equipment.
- The unit is positioned so that the operator,
when protected from radiation, can see and
hear the patient during an exposure.
To Next Page
Loading...
