Appendix D
D-2 Respironics V60 Ventilator User Manual 1047358 Rev N
Regulatory compliance
Electromagnetic
compatibility
declaration
Medical equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according
to the EMC information provided in this document.
WARNING: The V60 ventilator may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the ventilator or shielding
the location.
Electromagnetic emissions
ISO 14971; 2007 Medical devices – Application of risk management to medical
devices
EN ISO 14971;
2012
Medical devices – Application of risk management to medical
devices
ISO 80601-2-12;
2011
Medical electrical equipment – Particular requirements for basic
safety and essential performance of critical care ventilators
ISO 60529; Ed. 2.1 Degrees of protection provided by enclosures (IP Code)
IEC 62304; Ed. 1.0 Medical device software - Software life cycle processes
Guidance and manufacturer's declaration - electromagnetic emissions
The V60 Ventilator is intended for use in the electromagnetic environment specified below.
The user of the V60 Ventilator should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic enforcement - guidance
RF Emissions
CISPR 11
Group 1 The V60 Ventilator uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause interference in nearby electronic
equipment.
RF Emissions
CISPR 11
Class A The V60 Ventilator is suitable for use in all
establishments other than domestic, and may be used in
domestic establishments and those directly connected to
the public low voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
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