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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-US) 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 nebulizer with components specified
in the Instruction Manual. Use of the Aerogen Solo nebulizer with
components other than those specified in the Instruction Manual may
result in increased emissions or decreased immunity of the Aerogen
Solo nebulizer 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.
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