Philips Azurion - 17 Regulatory Information; 17.1 Frequently Used Functions; 17.2 Applied Parts

17 Regulatory In
formaon
The system complies with relevant internaonal and naonal standards and laws.
17.1 Frequently Used Funcons
The system provides the following frequently used funcons:
• Collimator movements, i.e. shuer movements with hardware buon
• Field of view adjustment
• Performing uoroscopy, for example:
– Selecng the uoroscopy avor
– Acvang uoroscopy with the foot switch
– Reviewing in last image hold
– Storing uoroscopy series and images
• Performing exposure, for example:
– X-ray protocols
– Acvang exposure with the foot switch
– Reviewing (image/series stepping and series cycle)
• C-arm movements
• Tabletop horizontal and transversal movements
• Changing the source-to-image distance
17.2 Applied Parts
An applied part is a part of the equipment that in normal use sases one of the following condions:
• The part must come into physical contact with the paent for the equipment to perform its
funcon.
• The part can be brought into contact with the paent.
• The part needs to be touched by the paent.
Normal use is dened as "operaon, including roune inspecon and adjustments by any OPERATOR,
and stand-by, according to the instrucons for use".
The following parts are regarded as applied parts:
• Tabletop: The applied part of the tabletop is dened as 220 cm from the edge of the head end
toward the foot end. Equipment aached to the foot end is not regarded as an applied part.
• Maress
• Arm supports
• Head-xing aids
• Paent straps
• Ratchet compressor (band only)
• Handgrips and clamps
The following parts are applied parts supplied by a third-party manufacturer:
• Injectors (a compability statement is provided with each injector)
• Operang tables (a compability statement is provided with each table)
• Neuro head holder
The following parts are considered accessible by the paent, and are therefore treated as applied parts:
• Table accessory rail
• Addional table accessory rail
• Table-mounted radiaon shield
Regulatory Informaon Frequently Used Funcons
Azurion Release 1.2 Ins
trucons for Use 342 Philips Healthcare 4522 203 52421