These operating instructions provide the necessary information for proper operation of all models of the EMMA. 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 EMMA are prerequisites for its proper use. Do not operate EMMA
without completely reading and understanding these instructions.
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.
Masimo Sweden AB
Svärdvägen 15
SE-182 33 Danderyd
Sweden
Telephone: +46 8 544 98
Fax: +46 8 544 98 169
www.masimo.com
3JSV
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) and CAN/CSA-C22.2 No. 60601-1 (2008)