CooperSurgical INCA Notice D'utilisation page 2

INCA Complete Set, Replacement Set and Accessory Pack
®
DEVICE DESCRIPTION
The INCA Complete Set 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 five
sets (Figure 2).
Complete Set P/N
44-2707
44-2709
44-2710
44-2712
44-2715
The INCA Replacement Set includes the nasal cannula, two lengths of
Stay-Flex tubing, two tubing adapters and one in-line pressure "T" adapter
(Figure 1).
Replacement Set P/N
44-0707
44-0709
44-0710
44-0712
44-0715
The INCA Accessory Pack includes five knit caps with hook/loop
band, five chin straps with ten hook fasteners (not attached) and ten
foam blocks.
Accessory Pack P/N
44-2001
44-2002
44-2003
44-2004
"Y" ADAPTER
(DO NOT USE)
Figure 1
Size
7.5F
9F
10.5F
12F
15F
Size
7.5
9F
10.5F
12F
15F
Size
X-Small
Small
Large
X-Large
INSPIRATORY OR
EXPIRATORY LIMB
TUBING
ADAPTER
PRESSURE LINE
PRESSURE
"T" ADAPTER
NASAL PRONGS
STAY-FLEX
TUBING
CANNULA
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.
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 the set are
non-sterile.
INSTRUCTIONS FOR USE – INCA COMPLETE SET
1. For appropriate nasal prong fitting, 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.
Figure 2
SIZES LISTED ARE SUGGESTED GUIDELINES ONLY
NEONATE WEIGHT
<700g
701 – 1000g
1001 – 1300g
1301 – 2000g
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
2
(English)
CANNULA SIZE
7.5F or 9F
10.5F
12F
15F
PRESSURE "T"
ADAPTER INSERT