Masimo NomoLine 3800 User Manual

NomoLine™
HH Multi-Patient Use Adapter
Reusable NomoLine sampling line adapter
PART NUMBER: 3800
© 2017 Masimo Corporation
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English 3-4
NomoLine™
HH Multi-Patient Use Adapter
Reusable NomoLine sampling line adapter
PART NUMBER: 3800
Fig. A
Fig. B
Fig. C
9840A-eIFU-1117
NomoLine™
PART NUMBER: 3800
en
HH Multi-Patient Use Adapter
Reusable NomoLine sampling line adapter
DIRECTIONS FOR USE
Reusable
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
• Do not apply negative pressure to remove condensed water.
• Dispose in accordance with local regulations for biohazardous waste.
• Do not submerge NomoLine HH Multi-Patient Use 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 NomoLine HH Multi-Patient Use Adapter.
• Do not use with inhalers or nebulized medications as this may clog the bacteria filter.
• Always replace the NomoLine HH Multi-Patient Use Adapter if an occlusion alarm occurs.
DESCRIPTION
The NomoLine HH Multi-Patient Use Adapter (part number 3800) is intended to be reused. It is intended to be used together with single-patient use NomoLine sampling lines (Airway adapter sets & Cannulas with Luer, part number 3801 to 3813 and 4368) for adult, pediatric, infant and neonatal patients. The NomoLine HH Multi-Patient Use Adapter is an accessory to the Masimo ISA™ sidestream gas analyzers. Refer to the ISA User’s Guide for technical specication and full system use instructions for the ISA product system. The table below describes which NomoLine single-patient use sampling lines can be used with the NomoLine HH Multi-Patient Use Adapter.
Part Number Product Name
3800 NomoLine HH Multi-Patient Use Adapter
Connects To 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 CO 3806 – NomoLine Infant Nasal CO 3807 – NomoLine Adult Nasal CO 3808 – NomoLine Pediatric Nasal CO 3809 – NomoLine Adult Nasal/Oral CO 3810 – NomoLine Pediatric Nasal/Oral CO 3811 – NomoLine Adult Nasal/Oral CO 3812 – NomoLine Pediatric Nasal/Oral CO 3813 – NomoLine Adult Single Nasal Prong CO 4368 – NomoLine Infant/Neonatal Airway adapter set with Luer
2 Cannula with Luer
2 Cannula with Luer
2 Cannula with Luer
2 Cannula with O2 and Luer
2 Cannula with O2 and Luer
2 Cannula with Luer
2 Cannula with Luer
2 Cannula with O2 and Luer
2 Cannula with O2 and Luer
2 Cannula with Luer
INSTRUCTIONS
Open the bag and remove the NomoLine HH Multi-Patient Use Adapter.
A. Connecting a NomoLine HH Multi-Patient Use Adapter to a NomoLine Sampling Line with Luer
• Refer to Fig. A: Connect the female Luer of the Multi-Patient Use Adapter with a twisting motion to the male Luer of
the NomoLine Sampling Line.
B. Connecting a NomoLine HH Multi-Patient Use Adapter to the ISA gas analyzer
• Refer to Fig. B: Insert the NomoLine HH Multi-Patient Use Adapter into the ISA gas inlet connector. Asteady green light
indicates that the NomoLine HH Multi-Patient Use Adapter is correctly connected to ISA.
C. Re-using a NomoLine HH Multi-Patient Use Adapter
• 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 below).
• Connect the new Sampling Line to the female Luer of the NomoLine HH Multi-Patient Use Adapter.
REPLACEMENT
The NomoLine HH Multi-Patient Use Adapter should be disposed of in accordance with local regulations for biohazardous waste and replaced according to good clinical practice or latest after 14 days of use. Occlusion is indicated by a red ashing light on the ISA gas inlet connector. Replace the NomoLine HH Multi-Patient Use Adapter and wait until the gas inlet connector switches to a steady green light.
LATEX
Not made with natural rubber latex
9840A-eIFU-1117
CLEANING
LATEX
To clean the NomoLine HH Multi-Patient Use Adapter, follow the instructions below:
• Refer to Fig. C: Wipe the exterior surface of the NomoLine HH Multi-Patient Use Adapter with a rotating movement using a clean cloth wet with 70% isopropyl alcohol.
• Visually inspect that the NomoLine HH Multi-Patient Use Adapter looks clean. If not, repeat the cleaning procedure.
• Make sure there is no visible moisture on the surface of the NomoLine HH Multi-Patient Use Adapter before re-use.
The interior of the NomoLine HH Multi-Patient Use Adapter is not intended to be cleaned. Do not submerge the NomoLine HH Multi-Patient Use Adapter in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method.
DISPOSAL
The NomoLine HH Multi-Patient Use Adapter 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 modied, 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.
The following symbols may appear on the product or product labeling:
SYMBOL DEFINITION SYMBOL DEFINITION SYMBOL DEFINITION
Follow Instructions for Use
Keep Dry
Storage Atmospheric PressureRange
Manufacturer Lot code
Use By YYYY-MM-DD
Not made with natural rubber latex
0413
Caution: Federal law (USA) restricts this device to sale by or on the order of aphysician
Mark of Conformity to European Medical Device Directive 93/42/EEC
Patents: http://www.masimo.com/patents.htm Masimo and
are federally registered trademarks of Masimo Corporation.
NomoLine and ISA are trademarks of Masimo Corporation.
Catalogue number (model number)
Masimo reference number
Storage Temperature Range
Storage Humidity Range
LH
(orange background)
HH
(yellow background)
LH/HH
(green background)
Collects water. Short term applications with lowhumidity
Removes aspired and condensed water. Long term applications with highhumidity
Use with NomoLine Cannulas and Airway Adapter Sets withLuer
Do not use if package isdamaged
Instructions/Directions for Use/Manuals are available in electronic format @ http://www.Masimo.com/ TechDocs
Note: eIFU is not available for CE mark countries.
9840A-eIFU-1117
Manufacturer:
Masimo Sweden AB, Svärdvägen 15, SE-182 33 Danderyd, Sweden www.masimo.com
Date of Issue: 2017-11-02
© 2017 Masimo Corporation
9840A-eIFU-1117
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