Masimo NomoLine ISA CO2 Manuale utente
Operator's Manual
NomoLine®
ISA™ CO2 Sidestream Gas Analyzer
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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.
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
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1:2005/A1:2012, CAN/CSA C22.2 No. 60601-1:2014, and
applicable Particular (EN/ISO 80601-2-55:2018) Standards for which the
product has been found to comply by Intertek.
Patents: www.masimo.com/patents.htm
Masimo®, ®, and NomoLine® are registered trademarks of Masimo Corporation.
ISA™ is a trademark of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2019 Masimo Corporation
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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: Description ------------------------------------------------------------------------------------ 13
General System Description-------------------------------------------------------------------------- 13
Features-------------------------------------------------------------------------------------------------- 13
NomoLine Sampling Lines --------------------------------------------------------------------------- 14
Chapter 2: Setting Up------------------------------------------------------------------------------------- 15
System Setup ------------------------------------------------------------------------------------------- 15
Chapter 3: Operation-------------------------------------------------------------------------------------- 17
LEGI Indicator ------------------------------------------------------------------------------------------ 17
Capnography Display ---------------------------------------------------------------------------------- 17
Chapter 4: Troubleshooting------------------------------------------------------------------------------19
Troubleshooting NomoLine ISA CO2 ---------------------------------------------------------------19
Chapter 5: Specifications--------------------------------------------------------------------------------- 21
Accuracy ------------------------------------------------------------------------------------------------- 21
Environmental------------------------------------------------------------------------------------------ 21
Physical Characteristics-------------------------------------------------------------------------------22
Electrical-------------------------------------------------------------------------------------------------22
Compliance----------------------------------------------------------------------------------------------22
Additional Specifications -----------------------------------------------------------------------------23
Symbols--------------------------------------------------------------------------------------------------26
Chapter 6: Service and Maintenance-------------------------------------------------------------------29
Cleaning -------------------------------------------------------------------------------------------------29
Maintenance--------------------------------------------------------------------------------------------29
NomoLine ISA CO2 Contents
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Repair Policy------------------------------------------------------------------------------------------- 30
Return Procedure ------------------------------------------------------------------------------------- 30
Sales & End-User License Agreement------------------------------------------------------------- 30
Limited Warranty -------------------------------------------------------------------------------------- 31
Exclusions ----------------------------------------------------------------------------------------------- 31
Limitation of Warranty-------------------------------------------------------------------------------- 31
End-User License --------------------------------------------------------------------------------------32
No Implied License------------------------------------------------------------------------------------33
Index ---------------------------------------------------------------------------------------------------------35
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About This Manual
This manual explains how to set up and use NomoLine® ISA™ CO2. Important safety
information relating to general use of NomoLine ISA CO2 appears in this manual. Read and
follow any warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
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Product Description, Features and
Indications for Use
Product Description
NomoLine® ISA™ CO2 is part of the ISA product family and is a sidestream gas analyzer
intended to be connected to other medical backboard devices for monitoring of breath rate
and carbon dioxide CO2gas concentration. NomoLine ISA CO2 supports various types of host
connectors for providing measured data.
Intended Use
NomoLine® ISA™ CO2 sidestream gas analyzer and accessories including NomoLine, is
intended to be connected to other medical backboard devices for monitoring of breath rate
and the following breathing gases:
•CO2
NomoLine ISA CO2 is intended to be connected to a patient breathing circuit for monitoring
of inspired/expired gases during anesthesia, recovery and respiratory care. The intended
environment is the operating suite, intensive care unit and patient room. NomoLine ISA CO2
is also intended to be used in road ambulances. The intended patient population is adult,
pediatric, infant and neonatal patients.
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