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:
WARNING:
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
Summary of Contents for Respironics V60
Page 1: ...Respironics V60 V60 Plus Ventilator User Manual ...
Page 2: ......
Page 8: ...viii ...
Page 28: ...2 10 Symbols ...
Page 44: ...3 16 General information ...
Page 60: ...4 16 Principles of operation ...
Page 74: ...5 14 Setting up the ventilator for use ...
Page 102: ...6 28 Operation ...
Page 110: ...7 8 High flow therapy ...
Page 114: ...8 4 Patient monitoring ...
Page 132: ...9 18 Alarms messages and troubleshooting ...
Page 142: ...10 10 Care and maintenance ...
Page 162: ...A 10 First time installation ...
Page 182: ...D 10 Regulatory compliance ...
Page 198: ...E 16 Diagnostic mode ...
Page 210: ...Index Index 6 ...
Page 211: ......