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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 CO
gas concentration. NomoLine ISA CO2 supports various types of host
2
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.
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O and/or anesthetic
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