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CONTROINDICAZIONI
Non esistono controindicazioni note.
PRODOTTO MONOUSO.
Il riutilizzo può portare alterazioni delle performance e rischi di
contaminazioni crociate. Smaltire dopo ogni uso.
Non riutilizzare o risterilizzare.
STERILE - Sterilizzato a ossido di etilene
MATERIALI UTILIZZATI Silicone.
DISPOSITIVO MEDICO NON PRODOTTO CON LATTICE
NATURALE
Legenda
01. Connettore per tubo di drenaggio
02.
Valvola anti-reflusso in ingresso
03. Valvola di tenuta unidirezionale in silicone
04. Serbatoio delle perdite d'aria
05. Punto di prelievo senz'ago
06. Adattatori
Data emissione ultima versione :
vedere ultima pagina : (REV.: XX-XXXX)
EN
P-EGGY Drain
Chest drain valve
UNICO percutaneous set accessory
INSTRUCTIONS FOR USE
DESCRIPTION
P-Eggy Drain chest drain valve is a disposable device consisting of a
medical grade silicone bulb with 100 ml collection chamber,
needleless access port for fluid withdrawal for emptying the bulb by
means of syringe (on the bottom of the valve). Compression of the
valve makes it possible to apply moderate and temporary negative
pressure onto the patient and check of the intensity of air leak.
The device consists of the following parts (Fig. 1):
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Medical grade silicone bulb with a connector (1) on top for direct
connection of drainage tubes or by means of adapters (6).
-
Inlet anti-reflux valve (2) to avoid potential reflux of drained fluids
towards the patient.
-
Silicone one-way seal valve (3) and air leak well (4) for the
evacuation of the patient's air and its confirmation.
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Needleless sampling point (5) for the removal of liquid that may be
present in the bulb by means of syringe.
-
Adapters (6) to allow connection to Redax UNICO percutaneous
set of various types and sizes: female "bayonet" adapter with tube
(Fig. 2a), male luer-lock connector with tube (Fig. 2b).
CLINICAL CONTEXT
In cases of traumatic, spontaneous, iatrogenic pneumothorax, etc. it is
necessary to apply a drainage that primarily allows the evacuation of
air from the patient's chest cavity, preventing reflux. For this reason, a
drainage catheter connected to a one-way valve (Heimlich or similar)
and collection systems such as bags, drainage systems, etc.) is often
applied to collect any drained liquid, usually a small amount.
The patient with pneumothorax may be able to walk and in many cases
is discharged at home with drainage until pneumothorax is reduced
and the drainage tube is removed; for this reason, easy to mobilize and
manage devices such as percutaneous drainage connected to the P-
Eggy Drain thoracic drain valve are preferred.
INTENDED USE
The device is indicated for the evacuation of air from the chest cavity of
the patient affected by pneumothorax of various origins (e.g.
spontaneous, iatrogenic, traumatic, etc.). This can restore normal
intrathoracic pressure gradients and facilitate complete lung
expansion, restoring normal respiratory dynamics. This device can be
used in adult and pediatric patients.
GENERAL WARNINGS
-
The product is sterile if the packaging is intact. Do not use if the
package has been opened or damaged.
-
Avoid exposure to high temperatures and ultraviolet rays during
storage.
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Dispose of after each single use, do not reuse or re-sterilize.
-
Do not clog the air leak well
-
Do not clamp the patient's tubeduring use.
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Do not use or prick the needleless access port with a needle.
-
Do not leave the syringe in the needleless sampling port.
NOTE: This device can be used in safety conditions only for the
applications and with the methods indicated in this operating
instruction sheet, according to the type of the product itself.
The manufacturer declines all liability arising from misuse and
any use different from that indicated.
The procedure should be carried out by trained and
experienced personnel and aware of safe techniques and
potential complications.
WARNINGS/PRECAUTIONS
-
The device should be positioned and used by
specialized personnel, aware of the implications of
the chest drainage procedure.
-
The device shall be handled by wearing protective
gloves and all devices specified in hospital
protocols to prevent cross-contamination of the
patient and/or operator.
-
Any liquid contained in the collection chamber
must never be reinfused, but disposed of with the
drainage system in accordance with the current
rules on biologically hazardous waste.
-
Replace P-Eggy Drain chest drain valve when the
volume of collected liquid exceeds the maximum
capacity.
-
If damaged, the P-Eggy Drain chest drain valve
should be replaced.
-
If there is evidence of occlusion, replace the
system.
-
Do not make a Y-connection between two catheters
and a P-Eggy Drain valve.
-
Make sure that the P-Eggy Drain valve is securely
connected to the catheter.
-
The connectors, present in the package, allow
connecting different types of drains to the P-Eggy
Drain chest drain valve. Be sure to check the
compatibility with the catheter you want to use
before you use it on the patient.
PREPARATION FOR USE
Proceed as follows:
1.
Pull the device out of its sterile casing.
2.
Visually verify that the device is intact and looks like in Fig. 1 and
that all accessories provided are present.
3.
Connect the drainage to the conical connector (1) of the P-Eggy
Drain valve using the adaptors in the package as shown in Fig. 2.
Make sure that the connection is firmly secured.
4.
Place the system, prepared as described, below the wound level
to immediately begin drainage by gravity.
Patient drainage
The device allows drainage by gravity of air and liquids from the chest
cavity of the patient. It is possible to compress the silicone bulb to
apply a moderate and temporary suction (max. -35 cmH2O) and to
check that the drainage tube is opened.
Sampling and emptying of the device
If the collection chamber is almost full, the liquid can be removed by
connecting a syringe, preferably equipped with a luer-lock connector
to the needleless sampling point (5) .
The procedure should be carried out according to the current hospital
provisions on infection prevention. Clean with alcohol or disinfectant
solution available the needleless port before and after applying the
syringe.
Patient air leak confirmation
It is possible to confirm the patient's air leaks by adding about 1 ml of
water into the air leakage well (4). The appearance of bubbling in
water (air bubbles) is an indicator of air leak from the patient.
Reduction in the amount of such bubbles over time indicates a
progressive reduction in leak and lung expansion. Empty the air leak
well after use.
Alternatively, it is enough to compress the silicone bulb and visually
check the expansion of the same: the faster the expansion will be, the
greater the air leak. When the lung expansion is complete, the bulb will
remain compressed.
Disconnecting the system
Clamp all catheters before disconnecting the chest drainage valve
from the patient.
REMOVAL/DISPOSAL
For the disposal and dismantling of the device, it is necessary to take
appropriate precautions and comply with the legal provisions in force
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