Device Description; Intended Users - Cooper Surgical Inca 44-27 Serie Instrucciones De Uso

INCA Complete Set, Replacement Set and Accessory Pack
®

DEVICE DESCRIPTION

The INCA Complete Set (44-27XX Series) consists of a nasal cannula,
two lengths of Stay-Flex tubing, two tubing adapters, one in-line "T"
pressure adapter, a knit cap with hook/loop band, two foam blocks and
a hook/loop chin strap (Figures 1 and 4). One INCA Sizing Gauge is
included in every box of fi ve sets (Figure 2).
The INCA Replacement Set (44-07XX Series) includes the nasal
cannula, two lengths of Stay-Flex tubing, two tubing adapters and one
in-line pressure "T" adapter (Figure 1).
The INCA Accessory Pack (44-20XX Series) includes fi ve knit caps with
hook/loop band, fi ve chin straps with ten hook fasteners (not attached)
and ten foam blocks.
ADAPTER
"Y" ADAPTER
(DO NOT USE)
Figure 1
INTENDED USE
For administering continuous positive airway pressure (CPAP) in
neonates.
WARNINGS
Use of this device can cause nasal septal erosion, necrosis or permanent
nasal damage.
Frequent observation of the neonate and prong position is essential.
If nasal irritation is observed, discontinue use immediately.
For single use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural integrity
of the device and/or lead to device failure which, in turn, may result in
patient injury, illness or death. Reuse, reprocessing or resterilization may
also create a risk of contamination of the device and/or cause patient
infection or cross-infection, including, but not limited to, the transmission
of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
Dispose of in accordance with all applicable Federal, State and local
Medical/Hazardous waste practices.
PLEASE NOTE: If a serious incident is suspected from using the INCA
Complete Set, Replacement Set and Accessory Pack, report the details
of the incident to CooperSurgical via phone number +1 203-601-5200
Ext 3100 or by email at ProductSurveillance@coopersurgical.com and
to the local Health Authority in your country. A serious incident may have
caused or contributed to a death, a delay in a procedure which resulted in
death or serious injury, or a malfunction that could have caused an adverse
event.
INSPIRATORY OR
EXPIRATORY LIMB
TUBING
PRESSURE
"T" ADAPTER
NASAL PRONGS
STAY-FLEX
TUBING
CANNULA

INTENDED USERS

Health care professionals in an acute care setting environment.
PATIENT POPULATION
Preterm neonate, neonate, infant, and pediatric population.
CONTRAINDICATIONS
Nasal septal erosion or necrosis
HOW SUPPLIED
Nasal Cannula (only) is packaged sterile for single use.
Do not reuse Nasal Cannula.The rest of the items in set are non-sterile
INSTRUCTIONS FOR USE – INCA COMPLETE SET
1. For appropriate nasal prong fi tting, use the INCA Sizing Gauge
P/N 025-001 (Figure 2). Wipe gauge with sterile 70% isopropyl
alcohol prior to each use. Hold the gauge up to the nasal area to
determine appropriate cannula size.
Note: Do not place sizing gauge in neonate's nares.
PRESSURE
LINE
SIZES LISTED ARE SUGGESTED GUIDELINES ONLY
2. Remove the nasal cannula from its sterile package. Insert the
nasal cannula several notches into the ends of the Stay-Flex tubing
securely. Expand the tubing to the desired length (Figure 3).
Figure 3
3. Disconnect "Y" adapter (Figure 1) from breathing circuit and do not
use. Attach inspiratory and expiratory limbs to INCA Stay-Flex tubing.
Remove Pressure "T" Adapter Insert (Figure 3) and connect pressure
monitor line to INCA "T" adapter. If the ventilator system does not
have a separate pressure monitoring line, remove "T" adapter and
replace with extra white adapter included in tray.
2
Figure 2
NEONATE WEIGHT
<700g
701 – 1000g
1001 – 1300g
1301 – 2000g
(English)
CANNULA SIZE
7.5F or 9F
10.5F
12F
15F
PRESSURE
"T" ADAPTER
INSERT