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LEGENDA
01
Camera di raccolta
02
Camera di tenuta ad acqua "sigillo"
03
Riempimento camera di tenuta
04
Tubo di drenaggio paziente
05
Maniglia
06
Raccordo conico tubo di drenaggio
07
Tappo autosigillante di prelievo
08
Attacco per unità di vuoto
09
Raccordo separazione aria/liquido
Data emissione ultima versione:
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DRENTECH SIMPLE 3
EN
DOUBLE-LUMEN TUBE
WITH
INSTRUCTIONS FOR USE
DESCRIPTION
TM
The systems called Drentech Simple are thoracic drains fitted with a
water seal valve separate from the collection chamber and designed for
use by suction or gravity. Use by suction is possible only by connecting
the system to the portable vacuum units of the Drentech
specifically designed to provide a portable suction source.
The "Simple 3 Double Lumen" device is composed of the following
parts:
1.
A collection chamber (1) made up of two or three graduated
segments. The collection chamber has a maximum capacity of
2200 cc.
2.
A water seal chamber (2) that prevents air backflow to the
patient's chest.
3.
A drain tube connector (9) fitted with a hydrophobic membrane
that separates air and fluid immediately at the catheter outlet.
4.
A double-lumen patient tube that allows conveying air and fluid
through separate ducts up to the collection receptacle. Any fluid
build-up in the main lumen of the patient tube is no longer an
obstacle to air evacuation, which occurs through the second
lumen separate from the first.
5.
The system is equipped with a self-sealing cap (7) for sampling
and qualitative evaluation of the drained fluid.
6.
This version is equipped with a dedicated valve located in the
connector (8) for fastening of the vacuum unit. This valve allows
connecting the patient suction and monitoring device called
PALM EVO. Monitoring is more effective and accurate thanks to
the second lumen of the patient tube, which facilitates measuring
patient air leakage and intrapleural pressure.
INSTRUCTIONS FOR USE
The Simple systems are suitable for: evacuating air and/or fluids from
the thoracic cavity or the mediastinum; preventing build-up of air
and/or fluids in the thoracic cavity; re-establishing and maintaining
normal intrathoracic pressure gradients; facilitating complete
pulmonary expansion to restore normal respiratory dynamics. The
systems can perform their function by gravity or suction.
Note:
This device can be used in safe conditions only in the
field of application and according to the procedures
indicated in this instruction leaflet in correspondence to
the type of product. The manufacturer declines all
responsibility for improper use or different from that
indicated.
WARNINGS/PRECAUTIONS
-
The drainage system must be held in vertical
position, including during transport, and always
below the fluid level of the pleural cavity (at least 50
cm).
-
Avoid looping or squashing the patient drain tube (4).
-
Do not obstruct or cover the seal chamber filling
connector (3).
-
Thanks to their particular design, the Simple systems
are stable and do not require an IV pole to use them
on the floor. The Simple systems have a handle (5) to
facilitate transport of the drainage unit. The handle
moreover allows hooking the device onto the
patient's bed.
-
Operation by suction is permitted only when
connected to the Redax portable vacuum units
which are expressly declared compatible. Suction
can be applied by means of an external line provided
that it is equipped with a thoracic regulator and
under direct responsibility of the attending
physician.
-
During operation by gravity, the water seal chamber
(2) acts as pressure gauge; it has a graduated wall
and provides the reading of the intrapleural pressure
value of the patient.
PREPARING THE DRENTECH SIMPLE SYSTEM
The system is packed in double sterile wrapping. In order to use the
product, take it out of its wrapping using a sterile technique.
a. Filling the seal chamber
1.
Prepare a preferably 60ml syringe.
2.
Insert the syringe in the connector (3) and fill the seal chamber (2)
with sterile water to over the broken line, which is the minimum
reference level and corresponds to 45cc. The water will turn blue
thanks to a dye contained in the chamber.
3.
When the device drains by gravity, the water seal acts as pressure
gauge. On the graduated scale of the relative column, you can
observe the intrathoracic pressure oscillations synchronous with
the patient's respiratory acts.
4.
Air bubbles may appear in the chamber underneath the water
seal; these indicate leakage from the pleural cavity, whose entity
can be qualitatively measured. These bubbles normally reduce
TM
line,
when the lung expands in the pleural cavity. If the phenomenon
persists after a careful check, ask a physician to intervene.
b. Connecting the drain tube
1.
Connect the drain tube (4) to the thoracic catheter of the patient by
means of the connector (6). At this point, the system is ready to
operate by gravity.
2.
For operation by suction, prepare a Redax portable vacuum unit
following the instructions given in the relative instruction leaflet.
Connect the unit to the dedicated connectors and start using the
device by controlled suction. Specific versions of the vacuum unit
allow objectively measuring some clinical parameters, such as
patient air leakage, etc.
c. Resetting high negative pressure
During operation by gravity (this does not occur using the vacuum
unit), high negative pressures may be created in the collection
receptacle. These pressures spontaneously balance out over
time. If you want to manually reset the pressure, operate as
follows:
* Systems equipped with a reset valve (8)
In this case, just act on the dedicated valve using a ballpoint pen
or similar. Pressing the valve will cause it to open and,
consequently, the liquid in the graduated column of the water seal
valve to go down.
WARNING:
Stop the reset when the liquid level has reached
zero. Do not keep the valve open for a prolonged
time during operation by gravity because of the
risk of pneumothorax.
GENERAL WARNINGS
Single-use device. Reuse may lead to alterations in performance and
cross-contamination risks. Do not use if the package has been opened
or damaged.
CONTRAINDICATIONS
There are no known contraindications.
STERILE - Sterilized by ethylene oxide
The product is sterile if the package is intact. Dispose of the device
after each single use; do not reuse. Avoid exposure to high
temperatures and ultraviolet rays during storage. Adopt adequate
precautions for elimination and disposal of the device and comply with
the provisions of the laws in force on biologically hazardous waste.
Note: the fluid contained in the collection chambers of the drainage
system may absolutely not be used for infusion.
MATERIALS USED: PS, PP, PVC.
LATEX-FREE MEDICAL DEVICE.
PVC-FREE PACKAGING.
LEGEND
01
Collection chamber
02
Water seal chamber
03
Seal chamber filling
04
Patient drain tube
05
Handle
06
Tapered drain tube connector
CONTRAINDICAÇÕES
Não se conhecem contraindicações.
ESTERILIZADO - Esterilizado com óxido de etileno
O produto considera-se esterilizado se a embalagem estiver intacta.
Eliminar após cada utilização, não reutilizar. Durante o
armazenamento evitar a exposição a temperaturas elevadas e aos
raios ultravioletas. Para a eliminação do dispositivo é necessário
adotar as precauções adequadas e respeitar as disposições
legislativas em vigor em matéria de lixo biologicamente perigoso.
Nota: o líquido presente nas câmaras de recolha do sistema de
drenagem não deve ser de forma alguma utilizado para
infusão.
MATERIAIS UTILIZADOS: PS, PP, PVC.
DISPOSITIVO MÉDICO ISENTO DE LÁTEX.
EMBALAGEM ISENTA DE PVC.
LEGENDA
01
Câmara de recolha
02
Câmara de retenção de água "selo"
03
Enchimento câmara de retenção
04
Tubo de drenagem do paciente
05
Pega
06
Junção cónica do tubo de drenagem
07
Tampa autovedante para colheita
08
Acoplador para unidade de vácuo
09
Junção da separação ar/líquido
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