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Aerogen® Solo System Instruction Manual 35
Appendix 1
Electromagnetic Susceptibility
This device meets the requirements of the Electromagnetic Compatibility
(EMC), pursuant to the Collateral Standard, IEC/EN 60601-1-2, which addresses
EMC in North America, Europe and other global communities. This includes
immunity to radio frequency electric fields and electrostatic discharge, in
addition to the other applicable requirements of the standard. Compliance with
EMC standards does not mean a device has total immunity; certain devices
(cellular phones, pagers, etc.) can interrupt operation if they are used near
medical equipment. Follow institutional protocol regarding the use and location
of devices that could interfere with medical equipment operation.
Note: This device is classified as Class II Type BF medical electrical equipment
and the device complies with specified safety levels for electrical isolation and
leakage current. The Aerogen Solo AC/DC adapter (AG-AP1040-XX*) has
no connection to earth ground because the necessary level of protection is
achieved through the use of double insulation.
Warnings
Only use the Aerogen Solo nebuliser with components specified in the
Instruction Manual. Use of the Aerogen Solo nebuliser with components
other than those specified in the Instruction Manual may result in increased
emissions or decreased immunity of the Aerogen Solo nebuliser system.
Do not use the Aerogen Solo adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the device should be observed to
verify normal operation in this configuration.
The Aerogen Solo needs special precautions regarding electromagnetic
compatibility (“EMC”) and must be installed and put into service according
to the EMC information provided in the Instruction Manual.
Portable and mobile radio frequency (“RF”) communication devices can
disrupt medical electrical equipment.
* Consult your local representative for the order number extension specific to your
country and for pricing information.
37


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