Aeroneb
®
Solo System Instruction Manual
29
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 Aeroneb 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 Aeroneb Solo nebulizer with components specified in the
Instruction Manual. Use of the Aeroneb Solo nebulizer with components other
than those specified in the Instruction Manual may result in increased emissions
or decreased immunity of the Aeroneb Solo nebulizer system.
•
Do not use the Aeroneb 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 Aeroneb 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.
