Philips Azurion - 1.3 Intended Use of the System; 1.4 Compatibility

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1.3 Intended Use of the System
CAUTION
In the Unit
ed States, Federal law restricts this device to sale, distribuon, and use by, or on the order
of, a physician.
Indicaons for Use
The Azurion series (within the limits of the used Operaon Room table) are intended for use to
perform:
• Image guidance in diagnosc, intervenonal and minimally invasive surgery procedures for the
following clinical applicaon areas: vascular, non-vascular, cardiovascular and neuro procedures.
• Cardiac imaging applicaons including diagnoscs, intervenonal and minimally invasive surgery
procedures.
Addionally:
• The Azurion series can be used in a hybrid Operaon Room.
• The Azurion series contain a number of features to support a exible and paent centric procedural
workow.
Paent Populaon
All human paents of all ages. Paent weight is limited to the specicaon of the paent table.
Intended Operator Prole
The Azurion series are intended to be used and operated by: adequately trained, qualied, and
authorized health care professionals who have understanding of the safety informaon and emergency
procedures as dened by local laws and regulaons for radiaon workers and sta.
Clinical Environment
The Azurion system is a xed and staonary system that can be used in a clinical environment fullling
the local laws and regulaons for radiological X-Ray systems in sterile and non-sterile environments.
General Safety and Eecveness
To facilitate safe and ecacious operaon of the system by a trained healthcare professional,
instrucons for use are provided as part of the device labeling, as well as training at system handover.
1.4 Compability
WARNING
Do not use the s
ystem in combinaon with other parts or products unless they are expressly
recognized as compable by Philips Medical Systems.
An overview of the compability of cerable components as required by 21CFR1020.30 (g) is available
on the InCenter Document Distribuon System. Log on to the following website with the InCenter user
account that is supplied with the system:
incenter.medical.philips.com
Introducon Intended Use of the System
Azurion Release 1.2 Ins
trucons for Use 16 Philips Healthcare 4522 203 52421