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1. Introduction
PaX-i Plus / Insight (Model: PCH-30CS) Installation Manual
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This equipment complies with the following
standards.
IEC60601-1-1:2005
Standard Safety Requirements for
Medical Electrical Equipment
IEC 60601-1-2:2005
Electromagnetic Interference
IEC 60601-1-3:2005
Radiation Protection
IEC 60601-1:2005
Standards for Medical Electrical
Equipment
IEC 60950-1: 2nd edition:2005
Standards for Information
Technology Equipment
IEC60601-2-7 and IEC60601-2-28
: X-ray Tube Heads
IEC60364-7-710: 2002
Local Code Requirements for
Electro-Medical System Installation
▪
IEC 60601-1-1:2005 regulation shall be met to their full
extent for the safety of the patients, operators, and the
environment—when any person assembles or modify a
medical electrical system by combing it with other
equipment.
▪
Any equipment not provided by VATECH can be
connected when the following standards are complied
with: IEC 60950-1 and IEC 60601-1
▪
The electrical installation shall comply with local code
requirements for electro-medical systems: IEC 60364-7-
710: 2002.