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These operating instructions intend to provide the necessary information for proper
operation of the NomoLine® ISA™ CO2 (NomoLine ISA CO2). General knowledge of
capnography monitoring and an understanding of the features and functions of NomoLine
ISA CO2 are prerequisites for proper use. Do not operate NomoLine ISA CO2 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.
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.
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.
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 Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1:2005+A1:2012 Cert. to CAN/CSA-C22.2
No.60601.1:2014 Ed.3 Standards for which the product has been found to
4004443
comply by Intertek.
Patents: www.masimo.com/patents.htm
ISA™ is a trademark of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2022 Masimo Corporation
www.masimo.com
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Contents
About This Manual ------------------------------------------------------------------------------------- 5
Product Description, Features and Indications for Use ------------------------------------------- 7
Product Description --------------------------------------------------------------------------------------7
Intended Use ---------------------------------------------------------------------------------------------7
Safety Information, Warnings and Cautions ------------------------------------------------------- 9
Safety Warnings and Cautions ------------------------------------------------------------------------ 9
Performance Warnings and Cautions --------------------------------------------------------------- 10
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 10
Compliance Warnings and Cautions ---------------------------------------------------------------- 11
Chapter 1: Technology Overview ------------------------------------------------------------------- 13
NomoLine ISA CO2 Technology Overview --------------------------------------------------------- 13
Chapter 2: Description ------------------------------------------------------------------------------- 15
General System Description -------------------------------------------------------------------------- 15
Features -------------------------------------------------------------------------------------------------- 15
NomoLine Sampling Lines --------------------------------------------------------------------------- 16
Chapter 3: Setting Up -------------------------------------------------------------------------------- 17
System Setup ------------------------------------------------------------------------------------------- 17
Chapter 4: Operation --------------------------------------------------------------------------------- 19
LEGI Indicator ------------------------------------------------------------------------------------------ 19
Capnography Display ---------------------------------------------------------------------------------- 19
Chapter 5: Troubleshooting ------------------------------------------------------------------------- 21
Troubleshooting NomoLine ISA CO2 --------------------------------------------------------------- 21
Chapter 6: Specifications ---------------------------------------------------------------------------- 23
Accuracy ------------------------------------------------------------------------------------------------- 23
Environmental ------------------------------------------------------------------------------------------ 23
Physical Characteristics ------------------------------------------------------------------------------- 24
Electrical ------------------------------------------------------------------------------------------------- 24
Compliance ---------------------------------------------------------------------------------------------- 24
Additional Specifications ----------------------------------------------------------------------------- 25
Guidance and Manufacturer's Declaration-Electromagnetic Emissions ----------------------28
Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 29
Symbols ------------------------------------------------------------------------------------------------- 30
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