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NomoLine™
Airway Adapter Sets and Cannulas
Single-patient use sampling lines
PART NUMBERS: 3801 to 3839, 4367 to 4369
© 2017 Masimo Corporation
Images 2-3
en
English 4-7
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NomoLine™
Airway Adapter Sets and Cannulas
Single-patient use sampling lines
PART NUMBERS: 3801 to 3839, 4367 to 4369
Fig. A1
Fig. A3
Fig. A2
Fig. A4
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NomoLine™
Airway Adapter Sets and Cannulas
Single-patient use sampling lines
PART NUMBERS: 3801 to 3839, 4367 to 4369
Fig. B1
Fig. C
Fig. B2
Fig. D
Fig. E
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NomoLine™
en
Airway Adapter Sets and Cannulas
Single-patient use sampling lines
PART NUMBERS: 3801 to 3839, 4367 to 4369
DIRECTIONS FOR USE
Single Patient Use Only
INDICATIONS
The NomoLine™ Product Family is indicated for the measurement of respiratory rate and respiratory and anesthetic gases in
adult, pediatric, infant and neonatal patients. The NomoLine Product Family includes single-patient use and multi-use devices
for gas sampling and/or oxygen delivery. The NomoLine Product Family is indicated for use by clinical professionals in healthcare
environments, including mobile environments.
WARNINGS
• Carefully route the NomoLine Sampling Line to reduce the risk of patient entanglement or strangulation.
• Do not apply negative pressure to remove condensed water.
• Dispose in accordance with local regulations for biohazardous waste.
• Do not submerge the NomoLine Sampling Line in any cleaning solution or attempt to sterilize by autoclave, irradiation,
steam, gas, ethylene oxide or any other method as this may seriously damage the NomoLine Sampling Line.
• Do not re-use due to cross contamination risk.
• Always replace the NomoLine Sampling Line if an occlusion alarm occurs.
• Do not use NomoLine Cannulas on patients with obstructions in one or both nostrils.
• The CO
2 measurement can be diminished if NomoLine Cannulas are used during mouth breathing or on a patient that has
a perforated septum.
• Do not use NomoLine Adult/Pediatric Airway Adapter Sets for infants/neonates as the adapter adds 6 ml dead space.
• Do not use NomoLine Infant/Neonatal Airway Adapter Sets for adults/pediatrics as this may cause excessive flow resistance
(0.7ml dead space).
• Do not use NomoLine Airway Adapter Sets with inhalers or nebulized medications as this may clog the bacteria filter.
DESCRIPTION
NomoLine Sampling Lines include nasal and nasal/oral cannulas for non-intubated patients and airway adapter sets for intubated
patients. The NomoLine Sampling Lines are accessories to the Masimo ISA sidestream gas analyzers. Refer to the ISA User’s Guide
for technical specication and full system use instructions for the ISA product system.
The table below describes the two groups of NomoLine single-patient use sampling lines:
• Group 1 (part number 3801–3813 and 4368) is intended to be used with NomoLine HH Multi-Patient Use Adapter (part
number 3800) that connects to the ISA gas inlet connector. See separate DFU for instructions regarding the NomoLine HH
Multi-Patient Use Adapter.
• Group 2 (part number 3814–3839, 4367 and 4369) is intended to be directly connected to the ISA gas inlet connector.
Airway adapter sets and Cannulas – single-patient use sampling lines
PART NUMBER – PRODUCT NAME
3801 – NomoLine Adult/Pediatric Airway adapter set with Luer
3802 – NomoLine Adult/Pediatric Airway adapter set 3m with Luer
3803 – NomoLine Infant Airway adapter set with Luer
3804 – NomoLine Adult Nasal CO
3805 – NomoLine Pediatric Nasal CO2 Cannula with Luer
3806 – NomoLine Infant Nasal CO2 Cannula with Luer
3807 – NomoLine Adult Nasal CO2 Cannula with O2 and Luer
3808 – NomoLine Pediatric Nasal CO2 Cannula with O2 and Luer
3809 – NomoLine Adult Nasal/Oral CO
3810 – NomoLine Pediatric Nasal/Oral CO
3811 – NomoLine Adult Nasal/Oral CO2 Cannula with O2 and Luer
3812 – NomoLine Pediatric Nasal/Oral CO2 Cannula with O2 and Luer
3813 – NomoLine Adult Single Nasal Prong CO2 Cannula with Luer
4368 – NomoLine Infant/Neonatal Airway adapter set with Luer
NomoLine
2 Cannula with Luer
2 Cannula with Luer
2 Cannula with Luer
LATEX
Not made with natural rubber latex
CONNECTS TO
NomoLine Multi-Patient
3800
UseAdapter
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Airway adapter sets and Cannulas – single-patient use sampling lines
NomoLine
CONNECTS TO
PART NUMBER – PRODUCT NAME
3814 – NomoLine LH Adult/Pediatric Airway adapter Set
3815 – NomoLine LH Adult/Pediatric Airway adapter set 3m
ISA gas inlet connector
3816 – NomoLine LH Infant Airway adapter set
3817 – NomoLine LH Adult Nasal CO
3818 – NomoLine LH Pediatric Nasal CO
2 Cannula
2 Cannula
3819 – NomoLine LH Infant Nasal CO2 Cannula
3820 – NomoLine LH Adult Nasal CO2 Cannula with O2
3821 – NomoLine LH Pediatric Nasal CO2 Cannula with O2
3822 – NomoLine LH Adult Nasal/Oral CO2 Cannula
3823 – NomoLine LH Pediatric Nasal/Oral CO2 Cannula
3824 – NomoLine LH Adult Nasal/Oral CO2 Cannula with O2
3825 – NomoLine LH Pediatric Nasal/Oral CO2 Cannula with O2
3826 – NomoLine LH Adult Single Nasal Prong CO2 Cannula
3827 – NomoLine HH Adult/Pediatric Airway adapter Set
3828 – NomoLine HH Adult/Pediatric Airway adapter set 3m
3829 – NomoLine HH Infant Airway adapter set
3830 – NomoLine HH Adult Nasal CO2 Cannula
3831 – NomoLine HH Pediatric Nasal CO2 Cannula
3832 – NomoLine HH Infant Nasal CO
3833 – NomoLine HH Adult Nasal CO
2 Cannula
2 Cannula with O2
3834 – NomoLine HH Pediatric Nasal CO2 Cannula with O2
3835 – NomoLine HH Adult Nasal/Oral CO2 Cannula
3836 – NomoLine HH Pediatric Nasal/Oral CO2 Cannula
3837 – NomoLine HH Adult Nasal/Oral CO
2 Cannula with O2
3838 – NomoLine HH Pediatric Nasal/Oral CO2 Cannula with O2
3839 – NomoLine HH Adult Single Nasal Prong CO2 Cannula
4367 – NomoLine HH Infant/Neonatal Airway adapter set
4369 – NomoLine LH Infant/Neonatal Airway adapter set
INSTRUCTIONS
• Open the bag and remove the NomoLine Sampling Line. For convenient preparations, do not yet remove the tape that keeps
the tubing coiled.
A. Fitting a NomoLine Cannula to the patient
• If fitting a NomoLine Nasal CO2 Cannula refer to Fig. A1: Insert the prongs into the nostrils.
• If fitting a NomoLine Nasal/Oral CO
front of the mouth.
• If fitting a NomoLine Single Nasal Prong CO
• Refer to Fig. A4: Pass the Cannula lines over the ears (1) and adjust the slider for comfort and fit under the chin (2). (This step
does not apply to NomoLine Single Nasal Prong CO
B. Connecting a NomoLine Airway Adapter Set to the patient circuit
• Refer to Fig. B1: Connect the small diameter end of the Airway Adapter to the Y-piece of the ventilation source.
2
Cannula refer to Fig.A2: Insert the prongs into the nostrils and position the oral scoop in
2
Cannula refer to Fig. A3: Insert the prong in one of the nostrils.
2
Cannula.)
• Refer to Fig. B2: Connect the large diameter end of the Airway Adapter to the patient’s endotracheal tube.
C. Connecting a NomoLine Sampling Line with Luer to NomoLine HH Multi-Patient Use Adapter
• Refer to Fig. C: Connect the male Luer of the NomoLine Sampling Line to the female Luer of the NomoLine HH Multi-Patient Use
Adapter with a twisting motion.
D. Connecting a NomoLine Sampling Line to the ISA gas analyzer
• Refer to Fig. D: Remove the tape that keeps the tubing coiled. Connect the NomoLine Sampling Line to the ISA gas inlet
connector. A steady green light indicates that the NomoLine Sampling Line is correctly connected to ISA.
• Ensure that the tubing is properly connected and that it is not twisted or crimped.
E. Connecting a NomoLine Cannula to an oxygen source
• Refer to Fig. E: Remove the tape that keeps the tubing coiled. Attach the oxygen supply tubing to the oxygen source. Adjust the
oxygen flow. (This step applies only to NomoLine Cannulas with O
2
.)
• Ensure that the tubing is properly connected and that it is not twisted or crimped.
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REPLACEMENT
NomoLine Sampling Lines are single patient use products and should after use be disposed of in accordance with local regulations
for biohazardous waste and replaced for each new patient with a maximum of 14 days of use*. They should also be replaced if
the sampling line becomes occluded. Occlusion is indicated by a red ashing light on the ISA gas inlet connector. Replace the
NomoLine Sampling Line and wait until the gas inlet connector switches to a steady green light.
* The lifetime of the product depends on the application and product type.
For NomoLine Sampling Lines with Luer (part number 3801–3813 and 4368) connected to NomoLine HH Multi-Patient Use
Adapter (part number 3800) after use:
• Keep the NomoLine HH Multi-Patient Use Adapter connected to the ISA gas inlet connector.
• Remove and discard the disposable, single-patient use NomoLine Sampling Line according to local regulations for
biohazardous waste.
• Clean the NomoLine HH Multi-Patient Use Adapter (see separate DFU for cleaning instructions regarding the NomoLine HH
Multi-Patient Use Adapter).
• Connect the new Sampling Line to the female Luer of the NomoLine HH Multi-Patient Use Adapter.
For NomoLine Sampling Lines (part number 3814–3839, 4367 and 4369) directly connected to the ISA gas inlet connector after use:
• Remove and discard the disposable, single-patient use NomoLine Sampling Line according to local regulations for biohazardous
waste.
• Connect the new Sampling Line to the ISA gas inlet connector.
CLEANING
NomoLine Sampling Lines (part number 3801–3839 and 4367 to 4368) are single-patient use products and should after use be
disposed of in accordance with local regulations for biohazardous waste.
To clean the NomoLine HH Multi-Patient Use Adapter (part number 3800) see separate DFU for cleaning instructions regarding the
NomoLine HH Multi-Patient Use Adapter.
DISPOSAL
The NomoLine Sampling Line may after use contain accumulated moisture and uids. Dispose the used product in accordance
with local regulations for biohazardous waste.
WARRANTY
MASIMO WARRANTS TO THE INITIAL BUYER ONLY THAT THESE PRODUCTS, WHEN USED IN ACCORDANCE WITH THE DIRECTIONS
PROVIDED WITH THE PRODUCTS BY MASIMO, WILL BE FREE OF DEFECTS IN MATERIALS AND WORKMANSHIP FOR A PERIOD OF
SIX (6) MONTHS. SINGLE USE PRODUCTS ARE WARRANTED FOR SINGLE PATIENT USE ONLY. THE FOREGOING IS THE SOLE AND
EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER
ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY
SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT.
WARRANTY EXCLUSIONS
This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the
product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any
product that has been connected to any unintended instrument or system, has been modied, or has been disassembled or
reassembled. This warranty does not extend to products that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR
CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN
NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT
OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT
SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED WITH A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED
OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE
PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.
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CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF APHYSICIAN.
LATEX
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings,
precautions and adverse events.
The following symbols may appear on the product or product labeling:
SYMBOL DEFINITION SYMBOL DEFINITION
Follow Instructions for Use Masimo reference number
Manufacturer Body weight
Use By YYYY-MM-DD
Do not re-use/Single Patient Use only
Not made with natural rubber latex Storage Humidity Range
Caution: Federal law (USA) restricts
this device to sale by or on the order
ofaphysician
Mark of Conformity to European
0413
MedicalDevice Directive 93/42/EEC
Keep Dry
Lot code
Catalogue number (model number)
Do not use if package is damaged
Patents: http://www.masimo.com/patents.htm
Masimo and
are federally registered trademarks of Masimo Corporation.
NomoLine and ISA are trademarks of Masimo Corporation.
≤
LH
(orange background)
HH
(yellow background)
LH/HH
(green background)
Less than or equal to
Storage Temperature Range
Storage Atmospheric Pressure Range
Gas sample
Collects water. Short term
applications with low humidity
Removes aspired and condensed water.
Longterm applications with high humidity
Use with NomoLine HH Multi-Patient
UseAdapter
Instructions/Directions for Use/Manuals are
available in electronic format @
http://www.Masimo.com/TechDocs
Note: eIFU is not available for
CE mark countries.
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Manufacturer:
Masimo Sweden AB,
Svärdvägen 15, SE-182 33
Danderyd, Sweden
www.masimo.com
Date of Issue: 2017-11-02
© 2017 Masimo Corporation
9841A-eIFU-1117
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