Philips Azurion - Page 345

The system equipment sas
es the terms of IEC 60601-1 and provides inside and outside the paent
environment, the level of safety spulated in IEC 60601-1 provided that the equipment has been
installed with the electrical safety measures described.
Each of the following equipment forms part of the system.
Azurion X-ray Equipment
The X-ray equipment can consist of the following main parts that are located inside the paent
environment:
• Table with control modules
• Frontal and lateral stands
– Frontal and lateral X-ray tube housing assemblies with beam liming devices
– Frontal and lateral detector assemblies
• Ceiling suspended monitors
• Oponal radiaon shields
• Oponal examinaon light
• Oponal injector
The X-ray equipment can consist of the following main parts that are located outside the paent
environment:
• Monitors
• Keyboard and mouse
• Control modules
• Workstaons
• Frontal and Lateral X-ray generators and cooling units
• Cabinets for system control/mains power distribuon with user interfaces and viewing monitors
Item Specicaon
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Locaon of the equipmen
t Partly inside and partly outside the paent environment
Electrical safety measures The electrical connecons to other Medical Electrical equipment are according
to IEC 60601-1. Connecons have to be made by service personnel according to
service instrucons.
Network W
orkstaon and Network Printer
Item Specicaon
IEC or ISO standard IEC standard
Locaon of the equipmen
t Outside the paent environment
Electrical safety measures The network workstaon or printer shall be connected via Ethernet isolator TN-
X2.
Room Interfaces
Item Specicaon
IEC or ISO standard IEC / CSA / ANSI / AAMI ES 60601-1
Locaon of the equipmen
t Inside and outside the paent environment
Electrical safety measures Only Philips Medical Systems service personnel are allowed to make connecons
for room interfaces.
Addional cabling and connector is provided by Philips Medical Systems.
Regulatory In
formaon Installaon and Equipment Connecons
Azurion Release 1.2 Ins
trucons for Use 345 Philips Healthcare 4522 203 52421