These operating instructions provide the necessary information for proper operation of all models of the Radius PCG.
There may be information provided in this manual that is not relevant for your system. General knowledge of
capnography and an understanding of the features and functions of Radius PCG are prerequisites for its proper use. Do
not operate Radius PCG without completely reading and understanding these instructions. If you encounter any
serious incident with product, please notify the competent authority in your country and the manufacturer.
Note
: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA)
and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures,
experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities,
or in any manner inconsistent with the directions for use or labeling.
Notice
: Purchase or possession of this device does not carry any express or implied license to use with replacement
parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.
CAUTION
: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for
full prescribing information, including indications, contraindications, warnings and precautions.
For professional use. See instructions for use for full prescribing information, including indications,
contraindications, warnings, and precautions.
Wireless Radio:
Contains: FCC ID: VKF-EMMABT | IC: 7362A-EMMABT | Model: EMMA Bluetooth
Masimo Sweden AB
Svärdvägen 15
SE-182 33 Danderyd
Sweden
Telephone: +46 8 544 98 150
Fax: +46 8 544 98 169
www.masimo.com
