D-1
Appendix D. Regulatory compliance
Electromagnetic
compatibility (EMC)
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/V60 Plus 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.
WARNING: Use of non-approved accessories, transducers or cables may increase
EMC emissions or decrease the EMC immunity performance of the
equipment.
WARNING: Use portable radio-frequency (RF) communications equipment (including
peripherals such as antenna cables and external antennas) no closer than
30 cm (12 in.) to any part of the ventilator system, including cables
specified for use with the ventilator. Otherwise, equipment performance
can be degraded. If higher immunity test levels than those specified in IEC
60601-1-2:2014, Table 9, are used, the minimum separation distance
may be lowered. Lower minimum separation distances shall be calculated
using the equation specified in chapter 8.10 of the standard.
WARNING: Do not use the ventilator near radio-frequency identification (RFID) or
electromagnetic security systems. The ventilator may disrupt the
operation of this equipment.
WARNING: This equipment is designed to comply with IEC 60601-1-2. This
equipment generates, uses, and can radiate radio-frequency energy and,
if not installed and used in accordance with instructions, may cause
harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation.
Harmful interference to other devices can be determined by turning this
equipment on and off. Try to correct the interference using one or more of
the following:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
IEC 60601-1-2;
2014, Ed. 4.0
Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Elec-
tromagnetic disturbances
To Next Page
Loading...
