MASiMO NomoLine-O Adapter User Guide

: June 6, 2024
: MASiMO

Table of Contents

NomoLine-O Adapter
NomoLine-O Adapter
DIRECTIONS FOR USE
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NomoLine-O Adapter

NomoLine-O Adapter - Fig. 2

DIRECTIONS FOR USE

Single patient use only Not made with natural rubber latex

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.

DESCRIPTION

The NomoLine-O adapter, when used with a NomoLine® sampling line, provides compatibility between NomoLine and capnography monitors that accept a sampling line with a single twist luer connector.

WARNINGS, CAUTIONS AND NOTES

Always refer to the sampling line and Capnography gas analyzer operator’s manual for complete instructions or additional instructions.
Do not use adapters that appear to be damaged or discolored, otherwise degraded performance can result.
Do not use adapters that cannot be properly secured to the sample line or compatible gas analyzer otherwise damage or separation can occur.
Do not use adapter with gas analyzer without sampling line attached, otherwise pump will start and gas measurements will be enabled.
Do not over-tighten adapter to the the Capnography gas analyzer as it may damage the adapter.
Do not re-use due to cross contamination risk.
All adapters are designed for use with luer-style connection Capnography gas analyzers. Verify the compatibility before use, otherwise degraded performance and/or patient injury can result.
Failure to properly connect the sampling line or the Capnography gas analyzer to the adapter may result in inaccurate results.
Do not submerge the sampling line and adapter 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 sampling line and adapter.

INSTRUCTIONS

Open the bag and remove the NomoLine-O Adapter.
Refer to Fig. 1. Plug the NomoLine sampling line into the adapter.
Refer to Fig. 2. Insert the sampling lines with the NomoLine-O adapter to the compatible gas analyzer.
Turn the sampling line with the NomoLine-O adapter clockwise into the compatible device’s gas sampling port until it is securely in place. Do not overtighten(see Cautions and Warnings).
To replace or remove the sampling line, turn the NomoLine-O adapter counter-clockwise from the device’s gas sampling inlet.
Unplug the sampling line from the NomoLine-O adapter.

CLEANING

NomoLine-O Adapter is a single patient use product and should after use be disposed of in accordance with local regulations for biohazardous waste and replaced for each new patient.

DISPOSAL

Dispose the used product when disposing the connected sampling line and in accordance with local regulations for biohazardous waste.

ENVIRONMENTAL

Storage Temperature -40 – +70 °C
Storage Humidity 10 – 95 % RH (95 % RH at 40 °C)
Storage Atmospheric Pressure 20 - 120 kPa
Operating Temperature 0 – +50 °C
Operating Humidity <5 kPa H2O (non-condensing) (41% RH at 50 °C)
Operating Atmospheric Pressure 52.5 - 120 kPa (< 4572 m)

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 modified, 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.

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.
The following symbols may appear on the product or product labeling:

SYMBOL| DEFINITION| SYMBOL| DEFINITION| SYMBOL| DEFINITION
---|---|---|---|---|---
| Follow instructions for use| | Date of manufacture YYYY-MM-DD| Rx ONLY| Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
| Consult instructions for use| | Lot code| | Authorized representative in the European community
| Manufacturer| | Catalogue number (model number)| | Non-Sterile
| Use-by

YYYY-MM-DD

0413

| Mark of Conformity to European Medical Device Directive 93/42/EEC| | Atmospheric pressure limitation| | Single patient – multiple use
| Medical device| | Unique device identifier| | Importer
| Distributor| | Instructions/Directions for Use/Manuals are available in electronic format
@ http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.

Masimo and NomoLine are federally registered trademarks of Masimo Corporation.

Manufacturer:
Masimo Corporation
52 Discovery
Irvine, CA 92618
USA

www.masimo.com

Authorized representative in the European community

MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany

10797A-eIFU-0521