Philips Azurion - 2.7 Radiation Safety

WARNING
The equipmen
t should not be used adjacent to, or stacked with, other equipment. If adjacent or
stacked use is necessary, the operator must verify that the system operates normally in the
conguraon in which it will be used.
The system is intended for use in a professional healthcare environment. Operaon in any other
environment may compromise electromagnec compability. The system and its components shall not
be directly connected to the public low-voltage power supply network.
The system complies with relevant internaonal and naonal laws and standards (IEC60601-1-2) on
electromagnec compability for this type of product, when it is installed and used as intended. These
laws and standards dene both the permissible electromagnec emission levels from the system and
its required immunity to electromagnec interference from external sources.
Other electronic products that exceed the limits dened in these standards could, in unusual
circumstances, aect the operaon of the system. Note the following:
• Radio services operang in frequency bands and disturbance characteriscs that are not covered by
CISPR11 edion 5 may be disturbed. If safety crical radio services are used in or near the facility
where the system is used, the responsible organizaon should evaluate the risks associated with
radio disturbance.
• Mobile devices can aect medical electrical equipment. Use cauon when using such devices
within the specied range of medical electrical devices.
For more informaon, see Electromagnec Compability (technical informaon) (page 322).
Essenal Performance
The essenal performance of the system (based on IEC60601-1) is: “Maintain uoroscopy during the
crical part of intervenonal procedures”.
2.7 Radiaon Safety
The system is intended for procedures in which air kerma levels can be high enough during normal use
to constute a risk of determinisc eects. To manage these risks, follow the radiaon guidelines in this
secon.
In accordance with IEC 60601-1-3:2008 (5.2.4.5 Determinisc Eects) and IEC 60601-2-54:2009
(203.5.2.4.5.101 Dosimetric Informaon), these Instrucons for Use provide measures to take to
reduce the risk of determinisc eects, for the intended use of the system. In general, you should work
in accordance with the ALARA (As Low As Reasonably Achievable) radiaon safety principles: minimize
radiaon me, maintain distance from the source and provide shielding. More specically, the
following measures should be taken to minimize the determinisc eects of X-ray radiaon on the
paent (in order of workow):
Paent Safety
• Never radiate unless absolutely necessary and only radiate for as short a me as possible.
• Select an appropriate X-ray protocol for the current procedure:
– For exposure, select an X-ray protocol with the lowest possible framespeed.
– For exposure, select an X-ray protocol with the lowest possible dose level.
– For uoroscopy, select the uoroscopy avor with the lowest dose level.
– For vascular procedures, make appropriate use of the mulphase speeds and do not use higher
frame rates than are necessary.
– For user-selected X-ray protocols, allow opmized operaon for indicated clinical protocols.
• Immobilise the paent to prevent the need to reacquire images due to paent movement.
• Select the appropriate paent type.
Safety Radiaon Safety
Azurion Release 1.2 Ins
trucons for Use 22 Philips Healthcare 4522 203 52421