Masimo NomoLine ISA CO2 Operator's Manual
NomoLine
ISA™ CO2 Sidestream Gas Analyzer
®
Operator's Manual
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
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
3149433
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
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NomoLine ISA CO2 Contents
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 CO2 gas 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:
• CO
2
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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Safety Information, Warnings and Cautions
CAUTION: NomoLine ISA CO2 is to be operated by, or under the supervision of, qualified
personnel only. Read this Operator's Manual, accessories directions for use, all precautionary
information, and specifications before use. Refer to the host device operator's manual or
user's guide for additional safety information, warnings and cautions.
Safety Warnings and Cautions
WARNING: Do not use NomoLine ISA CO2 if it appears or is suspected to be damaged.
Damage to the device can result in exposed electrical circuits that may cause patient harm.
WARNING: Do not adjust, repair, open, disassemble, or modify the NomoLine ISA CO2.
Damage to the device may result in degraded performance and/or patient injury.
WARNING: Do not start or operate the NomoLine ISA CO2 unless the setup was verified to be
correct. Improper set-up of this device may result in degraded performance and/or patient
injury.
WARNING: Do not place the NomoLine ISA CO2 or accessories in any position that might
cause it to fall on the patient.
WARNING: Only use Masimo authorized devices with NomoLine ISA CO2. Using
unauthorized devices with NomoLine ISA CO2 may result in damage to the device and/or
patient injury.
WARNING: Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
WARNING: Do not lift the NomoLine ISA CO2 by the NomoLine capnography sampling line as
it could disconnect from the NomoLine ISA CO2, causing the device to fall on the patient.
WARNING: Do not use the NomoLine ISA CO2 during magnetic resonance imaging (MRI) or
in an MRI environment.
WARNING: Only use sample lines intended for anesthetic agents if N
agents are being used.
WARNING: Do not re-use disposable single-patient use NomoLine Family sampling lines due
to the risk of cross contamination.
WARNING: Do not use the NomoLine Infant/Neonate Airway Adapter Sets for
adults/pediatrics as they may cause excessive flow resistance (0,7 ml dead space).
WARNING: Do not use the NomoLine Adult/Pediatric Airway Adapter Sets for
infants/neonates as the airway adapter adds 6 ml dead space.
WARNING: Do not apply negative pressure to remove condensed water from the NomoLine
Family sampling line.
WARNING: NomoLine ISA CO2 is not intended to be used for returning exhaust gases to the
patient circuit. Exhaust gases should be returned to a scavenging system.
Note: Disconnect the device from AC mains by removing the device cable connection from
the host device.
O and/or anesthetic
2
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NomoLine ISA CO2 Safety Information, Warnings and Cautions
Note: Use and store the NomoLine ISA CO2 in accordance with specifications. See the
Specifications section in this manual.
Performance Warnings and Cautions
WARNING: NomoLine ISA CO2 should not be used as the sole basis for medical decisions. It
must be used in conjunction with clinical signs and symptoms.
WARNING: Use of high-frequency electrosurgical equipment in the vicinity of NomoLine ISA
CO2 may produce interference and cause incorrect measurements.
WARNING: Do not use the NomoLine ISA CO2 with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
WARNING: Properly apply sampling lines according to the sampling lines directions for use.
Misapplied sampling lines that become partially dislodged may cause no or incorrect
readings.
WARNING: Replace the sampling line if the sampling line input connector starts flashing red,
or host device displays a check sampling line type of message.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
properly.
WARNING: Portable and mobile RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to
any part of the NomoLine ISA CO2 including the cable. Otherwise, degradation of the
performance of the NomoLine ISA CO2 could result.
WARNING: Too strong positive or negative pressure in the patient circuit might affect the
sample flow.
WARNING: Strong scavenging suction pressure might affect the sample flow.
CAUTION: Do not operate NomoLine ISA CO2 outside of the specific operating environment.
CAUTION: NomoLine ISA CO2 should be mounted securely to avoid risk of damage to the
NomoLine ISA CO2.
Cleaning and Service Warnings and Cautions
WARNING: To avoid electric shock, always physically disconnect the NomoLine ISA CO2 and
all patient connections before cleaning.
WARNING: Do not attempt to remanufacture, recondition or recycle the NomoLine ISA CO2
as these processes may damage the electrical components, potentially leading to patient
harm.
CAUTION: Do not sterilize or immerse NomoLine Family sampling lines in liquid.
CAUTION: To avoid permanent damage to the NomoLine ISA CO2, do not use undiluted
bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.
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