Table of Contents
Advertisement
Itamar Medical Ltd.
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO
IEC 60601-1 & 60601-1-2
Notes:
• The WatchPAT requires special precautions with regards to electromagnetic compatibility.
• Certain types of mobile telecommunication devices are likely to interfere with the
WatchPAT.
• The recommended separation distances in this section must therefore be complied with.
• The WatchPAT must not be used near or on top of another device. If this cannot be avoided,
it is necessary – before clinical use – to check the equipment for correct operation under the
conditions of use.
• The use of accessories other than those specified or sold by Itamar Medical as replacement
parts may have the consequence of increasing the emissions or decreasing the immunity of
the unit.
• The WatchPAT device does not have essential performance according to IEC 60601-1-2.
• WARNING: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the WatchPAT, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Electromagnetic Compatibility
Electromagnetic Emissions
• WatchPAT is intended for use in the electromagnetic environment specified in the following
tables 1, 2, 4 and 6 below.
• The user must ensure that it is used in such an environment.
• No unexpected behavior was detected during immunity testing and performance was met.
WatchPAT™ONE System
59
Operation Manual
Advertisement
Table of Contents
