Vatech Pax-i PCH-2500, Installation Manual

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PaX-i
(PCH-2500) Installation Manual
18
1 Introduction
Symbols Description Location
Caution: Federal law restricts this device to sale by or on the
order of a licensed healthcare practitioner.
Label
Indicates that the user needs to refer to the Instruction Manual. Label
Indicates the date of manufacture. Label
1.4 Standards and Regulations
A. Standards
This X-Ray equipment complies with the following standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-7,
IEC/EN 60601-2-28, IEC/EN 60601-2-32, ISO 9001, ISO 13485
2460 2460
The CE symbol indicates that this product complies with the European Directive for
Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIb device.
B.∙ Classification:∙(IEC60601-1∙6.1)
Protection against the ingress of water: IEC60529 edition 2.1
Ordinary Equipment: IPX0
Protection against electric shock:
Class
Ⅰ
equipment, Type B Applied Parts