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
www.masimo.com 1 Masimo
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
www.masimo.com 4 Masimo
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.
www.masimo.com 7 Masimo
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.
www.masimo.com 10 Masimo
NomoLine ISA CO2 Safety Information, Warnings and Cautions
CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
the NomoLine ISA CO2. These substances affect the device’s materials and device failure can
result.
CAUTION: Do not submerge the NomoLine ISA CO2 in any cleaning solution or attempt to
sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will
seriously damage the device.
CAUTION: To prevent damage, do not soak or immerse NomoLine ISA CO2 in any liquid
solution.
Compliance Warnings and Cautions
WARNING: Any changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
WARNING: Use of accessories and cables other than those specified or provided could result
in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING: Dispose NomoLine Family sampling lines in accordance with local regulations for
biohazardous waste.
CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its
accessories.
CAUTION: For FCC compliance information, refer to the host monitor Operator's Manual.
Note: Use the NomoLine ISA CO2 in accordance with the Environmental Specifications
section in the host monitor Operator's Manual.
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Chapter 1: Description
This chapter contains the description of the NomoLine ISA CO2 physical features.
General System Description
The NomoLine ISA CO2 system includes the following:
• NomoLine ISA CO2 Device
• NomoLine Sampling Line
For a complete list of compatible NomoLine sampling lines, cannulas, and related
consumables, visit www.masimo.com.
Features
Front View
1. NomoLine Capnography Input Connector
Allows connection to NomoLine® for capnography measurements.
Light Emitting Gas Inlet (LEGI) Indicator provides visual indications
of capnography status. See LEGI Indicator on page 17.
Rear View
2. Capnography Gas Sample Exhaust Port
Exhaust port for gas samples. See System Setup on page 15.
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NomoLine ISA CO2 Chapter 1: Description
NomoLine Sampling Lines
NomoLine ISA CO2 samples gas from the respiratory circuit through the NomoLine Family
sampling line at a rate of 50 sml/min, making measurements of CO
pediatric, infant and neonatal patients. The NomoLine Family of sampling lines are designed
for optimal performance and measurement fidelity when used with the NomoLine ISA CO2
gas analyzers.
NomoLine sampling lines include nasal and nasal/oral cannulas for non-intubated patients
with and without supplementary oxygen delivery and airway adapter sets for intubated
patients.
As long as no sampling line is connected, the NomoLine ISA CO2 gas analyzer remains in a
low-power sleep mode. Once the sampling line is connected, the NomoLine ISA CO2 gas
analyzer switches to measuring mode and starts delivering gas data.
For ordering information about NomoLine sampling lines, cannulas, and related
consumables, visit www.masimo.com.
possible for adult,
2
Sampling Line Replacement
NomoLine sampling lines should be replaced between each patient or when the sampling
line becomes occluded. Occlusion occurs when water, secretions etc. are aspirated from the
respiratory circuit to such an extent that NomoLine capnography cannot maintain the normal
50 ml/min sample flow. This is indicated by a red flashing LEGI indicator and an alarm
message; replace the sampling line and wait until the LEGI indicator switches to green,
indicating that the NomoLine ISA CO2 gas analyzer is again ready for use.
For ordering information about NomoLine sampling lines and related consumables, visit
www.masimo.com.
www.masimo.com 14 Masimo
Chapter 2: Setting Up
This chapter contains information about setting up NomoLine ISA CO2 before use.
System Setup
During setup, refer to the host device operator's manual or user's guide, in addition to the
following procedure.
1. Remove the temporary plug from the NomoLine Capnography input connector.
2. Securely mount the NomoLine ISA CO2.
Note: A bracket designed to mount NomoLine ISA CO2 is available, visit
www.masimo.com.
3. Connect the gas sample exhaust port on the rear of NomoLine ISA CO2 to a
scavenging system if intended to be used in combination with N2O and/or
anesthetic agents.
4. Connect the NomoLine ISA CO2 cable to the host device connection port.
5. Connect a NomoLine sampling line to the NomoLine ISA CO2 input connector. See
Front View on page 13.
6. Check that host device is powered up and correctly configured.
7. Check that the LEGI indicator shows a steady green light, indicating that
NomoLine ISA CO2 is ready for use. See LEGI Indicator on page 17.
Note: Without a sampling line connected, the LEGI Indicator does not illuminate.
8. Attach a NomoLine sampling line to the patient for monitoring. Refer to the
NomoLine sampling line Directions for Use.
9. Following connection of the NomoLine sampling line, check that CO
appear on the host device screen. See Capnography Display on page 17.
values
2
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Chapter 3: Operation
The information in this chapter assumes that NomoLine ISA CO2 is set up and ready for use.
This chapter provides necessary information for proper operation of the device. Do not
operate NomoLine ISA CO2 without completely reading and understanding these nstructions.
LEGI Indicator
The Light Emitting Gas Inlet (LEGI) Indicator provides visual indications of capnography
status. The LEGI Indicator (3) is located around the capnography connector on the front of
the device.
The LEGI indicator illuminates in different colors depending on the state of the device as
described in the table:
LEGI Indicator Status
Steady green light Capnography monitoring in operation and OK
Blinking green light Zeroing in progress. See Zeroing on page 30.
Steady red light Sensor error
Blinking red light Check the sampling line (possible occlusion)
Note: Without a NomoLine sampling line connected, the LEGI Indicator does not illuminate.
With no sampling line connected, NomoLine ISA CO2 stays in a low-power, sleep mode. Once
a sampling line is connected, NomoLine ISA CO2 switches to measuring mode and starts
delivering gas data.
Capnography Display
Parameters and measurements display on the screen of the host device that NomoLine ISA
CO2 is connected to. Refer to the host device operator's manual or user's guide for complete
information on displayed parameters, settings, alarms and messages.
www.masimo.com 17 Masimo
Chapter 4: Troubleshooting
Troubleshooting NomoLine ISA CO2
Symptom Possible Cause Correction
NomoLine ISA
CO2 values are
not displayed on
host monitor
LEGI indicator is
dark (indicator is
off)
LEGI indicator
blinking red
LEGI indicator
steady red
• NomoLine ISA CO2
requires a power cycle
• Host device is not
configured correctly or is
incompatible with
NomoLine ISA CO2
• NomoLine ISA CO2 is not
plugged in to the host
monitor connector
• Sampling line not plugged
in to NomoLine ISA CO2
completely
• Internal error
• Sampling line obstructed
(occlusion)
• NomoLine ISA CO2
requires a power cycle
• Internal error
• A hardware error is
generated during the
warm up period after being
stored at −40°C
• Disconnect and reconnect the
NomoLine ISA CO2 connector at
the host device.
• Verify that the host device is
correctly configured and
compatible with NomoLine ISA
CO2.
• Verify NomoLine ISA CO2
connection to the host monitor.
• Disconnect and reconnect the
sampling line to NomoLine ISA
CO2.
• The NomoLine ISA CO2 requires
service. See Service and Return
Procedure.
• Inspect sampling line for
occlusion (blockage, kink in line).
• Replace sampling line. See
Sampling Line Replacement on
page 14.
• Disconnect and reconnect the
NomoLine ISA CO2 connector at
the host device.
• If persistent, the NomoLine ISA
CO2 requires service. See Service
and Return Procedure.
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NomoLine ISA CO2 Chapter 4: Troubleshooting
Symptom Possible Cause Correction
Gas readings are
questionable
• Incorrect sampling line
used
• Sampling line attached
incorrectly
• Sampling line leaking
• Internal error
• Use the correct sampling line with
NomoLine ISA CO2.
• Disconnect and reconnect the
sampling line to NomoLine ISA
CO2.
• Follow the Directions for Use to
properly connect the sampling
line.
• Check sampling line for leaks.
• Replace sampling line. See
Sampling Line Replacement on
page 14.
• If persistent, the NomoLine ISA
CO2 requires service. See Service
and Return Procedure.
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Chapter 5: Specifications
Accuracy
Standard Conditions
The following accuracy specifications are valid for dry single gases at 22 ± 5 °C and 1013 ± 40
hPa:
Gas Range* Accuracy
CO2 0 to 15 vol%
15 to 25 vol%
*All gas concentrations are reported in units of volume percent and may be translated into
mmHg or kPa by using the reported atmospheric pressure.
All Conditions
The following accuracy specification is valid for all specified environmental conditions except
for interference specified in Effects from Water Vapor Partial Pressure on Gas Readings on
page 25 and Interfering Gas Vapor Effect on page 25.
Gas Accuracy
CO2 ±(0.3 kPa + 4% of reading)
±(0.2 vol% + 2% of reading)
Unspecified
Environmental
Environmental Conditions
Operating Temperature 0°C to 50°C (32°F to 122°F)
Storage/Transport Temperature* -40°C to 70°C (-40°F to 158°F)
Operating Humidity** 10% to 95% RH (non-condensing)
Storage/Transport Humidity
10% to 95% RH (non-condensing at ambient
temperature)
Ambient CO2 ≤ 800 ppm
Operating Atmospheric Pressure*** 525 mbar to 1,200 mbar (52.5 kPa to 120 kPa)
Storage/Transport Atmospheric
Pressure
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200 mbar to 1,200 mbar (20 kPa to 120 kPa)
NomoLine ISA CO2 Chapter 5: Specifications
* A warm up period of 10 minutes is required for the NomoLine ISA CO2 to fulfill the accuracy
specification if immediately put into use after being stored at −40°C. See Chapter 4:
Troubleshooting on page 19 for additional information.
** Not requiring partial pressure greater than 50 hPa, in accordance to IEC 60601-1-12.
*** CO
measurement inaccuracy shall be ± (0.3 kPa + 4 % of reading).
2
Physical Characteristics
Item Specification
Dimensions* 91 mm x 60 mm x 37 mm (3.6” x 2.4” x 1.4”)
Weight* Approx. 98 g (0.22 lbs)
* Excluding cable, tubing and NomoLine.
Electrical
Item Specification
Power Supply 4.5 to 5.5 VDC
< 0.9 W (normal operation)
< 1 W (peak @ 5 VDC)
Compliance
EMC Compliance
See host monitor Operator's Manual.
Safety Standards Compliance
IEC 60601-1:2005/AMD1:2012
IEC 62304:2006/AMD1:2015
EN/ISO 80601-2-55:2018
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NomoLine ISA CO2 Chapter 5: Specifications
Safety Standards Compliance
EN 30301-1:2006/AMD1:2013
IEC 60601-1-12:2014
ANSI/AAMI ES60601-1:2005/A1:2012
CAN/CSA C22.2 No. 60601-1:2014
Equipment Classification per IEC 60601-1
Type of Protection Class II
Degree of Protection of Electrical Shock Defibrillation proof BF-Applied Part
Protection against harm from liquid
ingress
IPX4, Protection against splashing of water from
all directions
Mode of Operation Continuous operation
Additional Specifications
General Specifications
Ambient CO2 ≤ 800 ppm (0.08 vol%)
Recovery Time After Defibrillator Test Unaffected
Drift of measurement Accuracy No drift
Interface RS-232 and USB
Water Handling NomoLine Family sampling lines with proprietary
Sampling Flow Rate*, ** 50 ± 10 sml/min
*Volumetric flow rate of air corrected to standardized conditions of temperature and pressure.
** Flow accuracy specification for the extended temperature range (-20°C to 0°C) is +15/-10
sml/min.
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water removal tubing.
NomoLine ISA CO2 Chapter 5: Specifications
Data Output Specifications
Breath detection Adaptive threshold, minimum 1 vol% change in CO2 concentration.
Respiration rate
0 to 150 ± 1 breaths/min
***
Fi and ET **** Fi and ET are displayed after one breath and have a continuously
updated breath average.
The following method is used to calculate end-tidal (ET) values:
• The highest concentration of CO
a weight function applied to favor values closer to the end of the
during one breathing cycle with
2
cycle.
ET will typically decrease below nominal value (ET
rate (RR) exceeds the RR threshold (RR
formula for CO
:
2
) according to the following
th
) when respiration
nom
(with NomoLine HH Adult/Pediatric Airway Adapter Set)
Flags Breath Detected, No Breath Detected, Check Sampling Line, Unspecified
Accuracy, Sensor Error
*** Measured at I/E ratio 1:1 using breath simulator according to EN ISO 80601-2-55 fig.
201.101.
**** Measured according to EN ISO 80601-2-55.
Gas Analyzer Specifications
Sensor head Dual channel NDIR type gas analyzer measuring at 3.5 to 4.5
μm.
Data acquisition rate 10 kHz (sample rate 20 Hz / channel).
Compensations Automatic compensation for pressure and temperature.
Manual compensation for broadening effects on CO
.
2
Calibration No span calibration is required.*****
Warm-up time < 10 seconds (Concentrations reported and full accuracy)
CO2 Rise time at 50
≤ 200 ms
sml/min sample flow
*****
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NomoLine ISA CO2 Chapter 5: Specifications
Gas Analyzer Specifications
Analyzer System
< 3 seconds
Response Time
***** An automatic zeroing is performed. See Zeroing on page 30.
Effects from Water Vapor Partial Pressure on Gas Readings
When the breathing gas flows through the sampling line, the gas temperature will adapt to
the ambient temperature before reaching the gas analyzer. The measurement of all gases will
always show the actual partial pressure at the current humidity level in the gas sample. As
the NOMO section removes all condensed water, no water will reach the NomoLine
Capnography gas analyzer. However at an ambient temperature of 37 °C and a breathing gas
with a relative humidity of 95% the gas reading will typically be 6% lower than corresponding
partial pressure after removal of all water.
Interfering Gas Vapor Effect
Gas or Vapor Gas Level CO2
N2O 4 60 vol% _ 2
HAL 4 4 vol% _ 1
ENF, ISO, SEV 4 5 vol% +8% of reading 3
DES 4 15 vol% +12% of reading 3
Xe (Xenon) 4 80 vol% -10% of reading 3
He (Helium) 4 50 vol% -6% of reading 3
Metered dose inhaler propellant 4 Not for use with metered dose inhaler propellants
C2H5OH (Ethanol) 4 0.3 vol% _ 1
C3H7OH (Isopropanol) 4 0.5 vol% _ 1
CH3COCH3 (Acetone) 4 1 vol% _ 1
CH4 (Methane) 4 3 vol% _ 1
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NomoLine ISA CO2 Chapter 5: Specifications
Gas or Vapor Gas Level CO2
CO (Carbon Monoxide) 5 1 vol% _ 1
NO (Nitrogen Monoxide) 5 0.02 vol% _ 1
O2 5 100 vol% _ 2
Note 1: Negligible interference, effect included in the specification “Accuracy, all
conditions” above.
Note 2: Negligible interference with N
in the specification “Accuracy, all conditions” above.
O / O2 concentrations correctly set, effect included
2
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically
decreases the CO
vol% CO
2
(1-0.06) * 5.0 vol% = 4.7 vol% CO
readings by 6%. This means that if measuring on a mixture containing 5.0
2
and 50 vol% Helium, the actual measured CO2 concentration will typically be
.
2
Note 4: According to the EN ISO 80601-2-55 standard.
Note 5: In addition to the EN ISO 80601-2-55 standard.
Symbols
The following symbols may appear on the product or product labeling:
Symbol Description Symbol Description
Follow instructions for use
Separate collection for electrical
and electronic equipment
(WEEE)
Protection against splashing of
water from all directions
Caution: Federal (USA) law
restricts this device to sale by or
on the order of a physician
Biohazardous Waste
Consult instructions for use
Mark of conformity to European
medical device directive
93/42/EEC
ETL Intertek certification
See Declarations on Page 1 for
certifications
Defibrillation-proof. Type BF
applied part
Serial number
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NomoLine ISA CO2 Chapter 5: Specifications
Symbol Description Symbol Description
CO
2
Lot Code
Storage temperature range
Keep dry
Storage humidity limitation
Gas inlet
Gas outlet
Class II Equipment
Catalog number (model
number)
Not made with natural rubber
latex
Fragile, handle with care
Atmospheric pressure limitation
Do not use if package is
damaged
Date of manufacture
YYYY-MM-DD
Manufacturer
China Restriction of Hazardous
Substances
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
www.masimo.com 27 Masimo
Chapter 6: Service and Maintenance
Cleaning
Cleaning of the NomoLine ISA CO2 should be performed at regular intervals or in accordance
with hospital, as well as local and governmental regulations.
See Safety Information, Warnings and Cautions on page 9.
WARNING: To avoid electric shock, always physically disconnect the NomoLine ISA CO2 and
all patient connections before cleaning.
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.
Note: To prevent cleaning liquids and dust from entering the NomoLine capnography gas
analyzer through its sampling gas inlet connector, keep the sampling line fitted while
cleaning NomoLine ISA CO2.
The surfaces of the NomoLine ISA CO2 may be cleaned with the following solution(s):
• 70% ethyl alcohol
• 70% isopropyl alcohol
• Glutaraldehyde Solution
• Quaternary Ammonium Chloride Wipe
• 0.5% Sodium Hypochlorite/Water Solution
• Accelerated Hydrogen Peroxide
Maintenance
Once every year it is recommended to perform maintenance on NomoLine ISA CO2. A
NomoLine ISA CO2 Maintenance Kit containing all required components and instructions to
perform maintenance procedures is available through www.masimo.com.
Operational Check
1. Connect the NomoLine ISA CO2 cable to the host device connection port.
2. Connect a NomoLine sampling line to the NomoLine ISA CO2 input connector.
3. Power up the host device.
4. Check that the LEGI indicator shows a steady green light, indicating that
NomoLine ISA CO2 is ready for use.
Note: Without a sampling line connected, the LEGI Indicator does not illuminate.
5. Breathe briefly into the sampling line and check that a valid CO
values are displayed on the host device screen.
6. Occlude (obstruct) the sampling line and wait for 10 seconds.
7. Check that an occlusion alarm is displayed and that the LEGI connector shows a
www.masimo.com 29 Masimo
flashing red light.
waveform and
2
NomoLine ISA CO2 Chapter 6: Service and Maintenance
Zeroing
The highly stable NomoLine ISA CO2 spectrometer requires no regular zeroing. A room air
reference measurement is performed when the NomoLine is disconnected from the LEGI
connector, provided that CO2 measurements are stable. This zeroing procedure is indicated by
the LEGI blinking green.
Repair Policy
Masimo or an authorized Service Department must perform warranty repair and service. Do
not use malfunctioning equipment. Have the instrument repaired.
Please clean contaminated and/or dirty equipment before returning, following the cleaning
procedure described in Cleaning Procedure. Make sure the equipment is fully dry before
packing.
To return the NomoLine ISA CO2 for service, please follow the Return Procedure below on
page 30.
Return Procedure
Clean contaminated/dirty equipment before returning, following instructions in the Cleaning
Procedure section. Make sure the equipment is fully dry before packing. Contact the seller to
request instructions on how to return the equipment. Package the equipment securely, in the
original shipping container if possible, and enclose or include the following information and
items (or other information as the seller requires):
• A letter describing in detail any difficulties experienced with the NomoLine ISA
CO2.
• Warranty information, a copy of the invoice or other applicable documentation
must be included.
• Purchase order number to cover repair if the NomoLine ISA CO2 is not under
warranty, or for tracking purposes if it is.
• Ship-to and bill-to information.
• Person (name, telephone/Telex/fax number, and country) to contact for any
questions about the repairs.
• A certificate stating the NomoLine ISA CO2 has been decontaminated for
bloodborne pathogens.
• Return the NomoLine ISA CO2 to the shipping address provided by the seller.
Sales & End-User License Agreement
This document is a legal agreement between you ("Purchaser") and Masimo Corporation
and/or its relevant subsidiary or affiliate ("Masimo") for the purchase of this Product
("Product") and a license in the included or embedded software and/or firmware ("Software").
Except as otherwise expressly agreed in a separate contract for the acquisition of this Product,
the following terms are the entire agreement between the parties regarding your purchase of
this Product. If you do not agree to the terms of this agreement, promptly return the entire
Product, including all accessories, in their original packages, with your sales receipt to
www.masimo.com 30 Masimo
NomoLine ISA CO2 Chapter 6: Service and Maintenance
Masimo for a full refund. BY ACCEPTANCE OR USE OF THIS PRODUCT, YOU ACKNOWLEDGE
YOUR ACCEPTANCE OF THESE TERMS.
Limited Warranty
Masimo warrants to the original end-user Purchaser that the Product and any Software media
contained in the original packaging will conform to Masimo’s published specifications in
effect at the time of manufacture when used in accordance with Masimo’s user manuals,
technical specifications, and other Masimo published guidelines for a period of 12 months
and any batteries for six (6) months from the original date the Product was obtained by the
end-user purchaser.
Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any
defective Product or Software media that is covered under the warranty.
To request a replacement under warranty, Purchaser must contact the seller, and follow all
instructions and procedures given by the seller. If Masimo determines that a Product must be
replaced under warranty, it will be replaced and the cost of shipment covered. All other
shipping costs must be paid by Purchaser.
Exclusions
The warranty does not apply to any non-Masimo branded product or any software, even if
packaged with the Product, or any Product that was: (a) not new or in its original packaging
when supplied to purchaser; (b) modified without Masimo’s written permission; (c) damaged
by supplies, devices, or systems external to the Product; (d) disassembled, reassembled, or
repaired by anyone other than a person authorized by Masimo; (e) used with other products,
like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be
used with the Product; (f) not used or maintained as provided in the operator’s manual or as
otherwise provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h)
damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause.
No warranty applies to any Product provided to Purchaser for which Masimo, or the seller,
is not paid; and these Products are provided AS-IS without warranty.
Limitation of Warranty
Except as otherwise required by law or altered by the purchase agreement, the above
warranty is the exclusive warranty that applies to the Product and Software media, and
Masimo does not make any other promises, conditions, or warranties regarding the
Product. No other warranty applies, express or implied, including without limitation, any
implied warranty of merchantability, fitness for a particular purpose, satisfactory quality,
or as to the use of reasonable skill and care. See the licensing terms for the terms and
conditions that apply to any Software accompanying the Product. Additionally, Masimo will
not be liable for any incidental, indirect, special, or consequential loss, damage, or expense
arising from the use or loss of use of any Products or Software. In no event shall Masimo’s
liability arising from any Product or Software (under contract, warranty, tort, strict liability, or
otherwise) exceed the amount paid by purchaser for the Product or Software. The above
limitations do not preclude any liability that cannot legally be disclaimed by contract.
www.masimo.com 31 Masimo
NomoLine ISA CO2 Chapter 6: Service and Maintenance
End-User License
1. Grant of License. In consideration of payment of the license fee, which is part of
the price paid for this Product, Masimo grants to Purchaser a nonexclusive,
nontransferable license, without right to sublicense, to use the copy of the
incorporated Software and documentation in connection with Purchaser's use of
the Masimo Products for their labeled purpose. Masimo reserves all rights not
expressly granted to Purchaser.
2. Ownership of Software/Firmware. Title to, ownership of, and all rights and
interests in, any Masimo software and/or firmware and the documentation, and all
copies thereof, remain at all times vested in Masimo Corporation and they do not
pass to Purchaser.
3. Assignment. Purchaser shall not assign or transfer this License, in whole or in part,
by operation of law or otherwise, without Masimo's prior written consent; any
attempt without such consent, to assign any rights, duties or obligations arising
under this license is void.
4. Copyright Restrictions. The Software, mask works, circuit board layouts, and
accompanying written materials are copyrighted. Unauthorized copying of the
Software, including Software that has been modified, merged, or included with
other software, or other written materials is expressly forbidden. You may be held
legally responsible for any copyright infringement that is cause or incurred by your
failure to abide by the terms of this license. Nothing in this license provides any
rights beyond those provided by applicable law.
5. Use Restriction. As the Purchaser, you may physically transfer the Product from
one location to another provided that the Software is not copied. You may not
electronically transfer the Software from the Product to any other device. You may
not disclose, publish, translate, release, distribute copies of, modify, adapt,
translate, reverse engineer, decompile, disassemble, or create derivative works
based on the Masimo Product, the Software, or the written materials without the
prior written consent of Masimo. Masimo sensors that are designated for single
use are licensed under Masimo patents for use on a single patient only, and are not
sold. Masimo reusable sensors are licensed under Masimo patents for use on more
than a single patient, but are not sold. Possession of any Masimo device does not
convey any express or implied license to use the device with unauthorized sensors
or cables that would, alone, or in combination with this device, fall within the
scope of one or more of the patents relating to this device. There is no license,
implied or otherwise, that would allow use of single use Masimo sensors beyond
their intended single use. After use of single use Masimo sensors, there is no
further license granted by Masimo to use the sensors and they must be discarded.
6. Non-Authorized Accessories. Masimo technology is designed to operate together
with Masimo cables, sensors and accessories as an integrated system. When any
component of the system is compromised, erroneous measurements can occur.
Accordingly, the use of unauthorized sensors or accessories, such as third-party
reprocessed or copycat sensors can yield unreliable results when used with a
Masimo device. The performance of Masimo technology is not validated when
used with any unauthorized sensor or accessory.
7. Transfer Restrictions. The Software is licensed to the Purchaser, and may not be
transferred to anyone, except other end-users, without the prior written consent of
Masimo. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose
of the Software or the Product on a temporary basis. Any attempt to assign any
rights, duties or obligations arising hereunder other than as set forth in this
paragraph shall be void.
www.masimo.com 32 Masimo
NomoLine ISA CO2 Chapter 6: Service and Maintenance
8. Beneficiary. Masimo Corporation is a third-party beneficiary of the above license
and has the right to enforce its provisions.
9. U.S. Government Rights: If Purchaser is acquiring Software (including the related
documentation) on behalf of any part of the United State Government, the
following provisions apply: the Software is deemed to be "commercial software"
and "commercial computer software documentation," respectively pursuant to
DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification,
reproduction, release, performance, display or disclosure of the Software (including
the related documentation) by the U.S. Government or any of its agencies shall be
governed solely by the terms of this Agreement and shall be prohibited except to
the extent expressly permitted by the terms of this Agreement.
10. Patents. The Masimo technology in the Masimo product is covered under one or
more patents set forth at www.masimo.com/patents.htm.
No Implied License
Possession or purchase of the Product does not convey any express or implied license to use
the device with unauthorized sensors or cables that would, alone, or in combination with the
device, fall within the scope of one or more of the patents relating thereto.
www.masimo.com 33 Masimo
Index
A
About This Manual • 5
Accuracy • 21
Additional Specifications • 23
C
Capnography Display • 15, 17
Chapter 1
Description • 13
Chapter 2
Setting Up • 15
Chapter 3
Operation • 17
Chapter 4
Troubleshooting • 19, 22
Chapter 5
Specifications • 21
Chapter 6
Service and Maintenance • 29
Cleaning • 29
Cleaning and Service Warnings and
Cautions • 10
Compliance • 22
Compliance Warnings and Cautions • 11
E
Effects from Water Vapor Partial Pressure
on Gas Readings • 21, 25
Electrical • 22
End-User License • 32
Environmental • 21
Exclusions • 31
G
General System Description • 13
I
Intended Use • 7
Interfering Gas Vapor Effect • 21, 25
L
LEGI Indicator • 13, 15, 17
Limitation of Warranty • 31
Limited Warranty • 31
M
Maintenance • 29
N
No Implied License • 33
NomoLine Sampling Lines • 14
O
Operational Check • 29
P
Performance Warnings and Cautions • 10
Physical Characteristics • 22
Product Description • 7
Product Description, Features and
Indications for Use • 7
R
Rear View • 13
Repair Policy • 30
Return Procedure • 30
F
Features • 13
Front View • 13, 15
www.masimo.com 35 Masimo
S
Safety Information, Warnings and
Cautions • 9, 29
Safety Warnings and Cautions • 9
NomoLine ISA CO2 Index
Sales & End-User License Agreement •
30
Sampling Line Replacement • 14, 19, 20
Symbols • 26
System Setup • 13, 15
T
Troubleshooting NomoLine ISA CO2 • 19
Z
Zeroing • 17, 25, 30
www.masimo.com 36 Masimo
www.masimo.com
300106/LAB-10152A-0219
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