Device Description; Intended Use; Contraindications; How Supplied - CooperSurgical INCA Anweisungen

®
INCA
Complete Set, Replacement Set and Accessory Pack

DEVICE DESCRIPTION

The INCA Complete Set consists of a nasal cannulae, two lengths of
Stay-Flex tubing, two tubing adapters, one in-line "T" pressure adapter, a
knit cap with hook/loop strap, 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
INCA Replacement Set
The
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
INCA Accessory
The Pack includes five knit caps with hook/loop
strap, 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
TUBING
ADAPTER
"Y" ADAPTER
NASAL PRONGS
DO NOT USE
CANNULAE
Figure 1
95 Corporate Drive • Trumbull, CT 06611 USA
Phone: (800) 243-2974 • Fax: (800) 262-0105
37368-DFU • Rev. A • 11/13
Size
7.5F
9F
10.5F
12F
15F
includes the nasal cannulae,
Size
7.5
9F
10.5F
12F
15F
Size
X-Small
Small
Large
X-Large
INSPIRATORY OR
EXPIRATORY LIMB
PRESSURE LINE
PRESSURE
"T" ADAPTER
STAY-FLEX
TUBING
International
Phone: (203) 601-9818
Fax: (203) 601-4747

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.

CONTRAINDICATIONS

Nasal septal erosion or necrosis

HOW SUPPLIED

Nasal Cannulae (only) are packaged sterile for single use.
Do not reuse.
INSTRUCTIONS FOR USE – INCA COMPLETE SETS
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 cannulae 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 cannulae base from its sterile package. Insert the
nasal cannulae 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.
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherldands
(English)
CANNULAE SIZE
7.5F or 9F
10.5F
12F
15F
PRESSURE "T"
ADAPTER INSERT