WatchPAT™300 System
57
Operation Manual
APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2
Notes
• The WatchPAT™300 (WP300) requires special precautions with regard to electromagnetic compatibility.
• It must be installed and prepared for use as described in section 11 - Preparation for Sleep Study.
• Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the
WP300.
• The recommended separation distances in this section must therefore be complied with.
• The WP300 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.
• To ensure “Isolation means” disconnect the power supply.
Electromagnetic Compatibility
Electromagnetic Emissions
•
WP300
is intended for use in the electromagnetic environment specified in the following tables 1, 2, 4 and 6
below.
• The user and/or installer of the unit must ensure that it is used in such an environment.
Table 1
– from IEC 60601-1-2:2014
Guidance and manufacturer's declaration
– electromagnetic emissions – WP300
The
WP300
is intended for use in the electromagnetic environment specified below; The customer or the user of the
WP300
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The
WP300
uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The
WP300
is suitable for use in all establishments, including 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
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Table 2 - from IEC 60601-1-2:2014
Guidance and manufacturer's declaration
– electromagnetic immunity – WP300
