Directions For Use - Masimo NomoLine ISA Mode D'emploi

NomoLine
Gas Exhaust Kit
DESCRIPTION
The NomoLine ISA™ Gas Exhaust Kit is intended to connect the ISA gas exhaust port or the gas exhaust port of a host device
®
with a built in ISA module to a scavenging system in order to discard the exhaust gas.
WARNINGS, CAUTIONS AND NOTES
• Do not use the ISA Gas Exhaust Kit for return of exhaust gas to the patient circuit.
• Replace the ISA Gas Exhaust Kit if it is damaged or worn out.
• Dispose the ISA Gas Exhaust Kit in accordance with local regulations for biohazardous waste.
INSTRUCTIONS
1. Fit the open end of the tubing to the ISA or the host gas exhaust port marked with (
2. Make sure that the tubing is firmly seated by gently pulling the tubing away from the exhaust port (Fig B).
3. Fit the conical Luer Slip to a suitable port on the scavenging system. Other means of connections to a scavenging system
could be used but in all cases a deliberate leakage must be generated to avoid a vacuum in the ISA's Gas Exhaust tubing
(Fig C).
4. Check that the tubing is not kinked or damaged before using the ISA system.
CLEANING
The ISA Gas Exhaust Kit is reusable and the tube may be cleaned using a cloth moistened with 70% isopropyl alcohol or 70%
ethyl alcohol.
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
Follow instructions for use
Consult instructions for use
Manufacturer
Use-by
YYYY-MM-DD
Not made with natural rubber latex
LATEX
Caution
Distributor
Mark of Conformity to European
Medical Device Directive 93/42/EEC
Masimo and NomoLine are federally registered trademarks of Masimo Corporation.
ISA is a trademark of Masimo Corporation.
ISA™
®
D I RE C TIONS F OR USE
SYMBOL
Gas exhaust
Lot code
Catalogue number (model number)
Masimo reference number
Storage temperature range
Storage humidity limitation
Atmospheric pressure limitation
Instructions/Directions for Use/Manuals are available in electronic format
@ http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
DEFINITION SYMBOL
3
) (Fig A).
DEFINITION
Caution: Federal law (USA) restricts
this device to sale by or on the order
of a physician
Authorized representative in the
European community
Keep dry
Do not use if package is damaged
and consult instructions for use
Medical device
Importer
Unique device identifier
11300B-eIFU-1021
en