Regulatory Notices for the LungLife
CE Notice
Marking by the symbol indicates compliance of the this devise to the Medical Devices Directive of
the European Community. Such marking is indicative that the Vitalograph copd-6/Bedfont LungLife
meets or exceeds the referenced technical standards.
The device 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.
The device is battery operated and 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.
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of the system should assure that it is used in such an environment.
• Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the
relative humidity should be at least 30%.
• Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.
• Interference may occur in the vicinity of equipment marked with the following symbol - .
FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a physician.