baxter COSEAL Spray Set Bedienungsanleitung

COSEAL SPRAY SET
u
x
w
u Double Syringe System containing
COSEAL Surgical Sealant
v EASYSPRAY Clip
w Spray Head
x Retention Clips
y Pressure Line
z Sensor Line
{ C-Clamp
| Sterile Filters
 EASYSPRAY Pressure Regulator
u Система с двукамерна
спринцовка, съдържаща
хирургическо лепило COSEAL
v Щипка EASYSPRAY
w Пулверизираща глава
x Прикрепващи щипки
y Линия за налягане
z Сензорна линия
{ C-Скоба
| Стерилни филтри
 Регулатор на налягане
EASYSPRAY
u systém dvojité tříkačky obsahující
chirurgické lepidlo COSEAL
v svorka EASYSPRAY
w sprejovací hlavice
x uchycovací spony
y tlaková linka
z snímací linka
{ C-svorka
| sterilní filtry
 regulátor tlaku EASYSPRAY
u Dobbeltkammersprøjte med
COSEAL kirurgisk vævsklæber
v EASYSPRAY klips
w Spraydyse
x Holdeklips
y Trykslange
z Sensorslange
{ C-klemme
| Sterile filtre
 EASYSPRAY trykregulator
u Dubbel spuitsysteem met de
chirurgische weefsellijm COSEAL
v EASYSPRAY-houder
w Spraytip
x Houders
y Drukslang
z Sensorslang
{ C-klem
| Sterilisatiefilters
 EASYSPRAY-drukregelaar
u Applikointipidike, jossa
COSEAL- kudosliimaruiskut
v EASYSPRAY-pidike (männän
pidike)
w Sumutinkärki
x Painikkeet
y Paineletku
z Anturiletku
{ Sulkija
| Steriilit suodattimet
 EASYSPRAY-paineensäätölaite
INSTRUCTIONS FOR USE
COSEAL Spray Set
For the Application of COSEAL Surgical Sealant.
The COSEAL Spray Set is used in conjunction with COSEAL Surgical Sealant
and the EASYSPRAY Pressure Regulator.
1. FIELD OF APPLICATION
The COSEAL Spray Set has been designed to work with the COSEAL Surgical Sealant and EASYSPRAY Pressure
Regulator for the application of COSEAL Surgical Sealant onto broad surface areas.
It has been found especially useful for indications where the application of a uniform coating of COSEAL Surgical Sealant
is essential over a larger surface area.
2. DESCRIPTION
Spray set consisting of:
2 Spray Heads
1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with
a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
2.1 Principle
Inside the spray head, which is attached to the double syringe system containing the COSEAL Surgical Sealant, the two
solutions are passed through two adjacent outlets. These two openings are encircled by the pressurized gas exit. The
gas flow atomizes and mixes the two solutions.
The pressure and flow rate of the pressurized gas are controlled by the EASYSPRAY Pressure Regulator. The spray set
must be used only in connection with the EASYSPRAY Pressure Regulator.
The gas flow is activated by occluding the opening on the EASYSPRAY-Clip attached to the COSEAL Surgical Sealant
plunger with the thumb.
2.2 Symbols and explanations
Caution
Single use
Do not use if the product, its sterile barrier
system or its packaging is damaged or
shows any sign of deterioration
Not made with natural rubber latex
Sterilized by ethylene oxide
Temperature limitation
(store between 2°C to 30°C
or between 36°F to 86°F respectively)
Non-pyrogenic in unopened and undamaged package.
Phthalates:
Only tubings contain DEHP. No DEHP extracted by pressurized gas.
3. OPERATING INSTRUCTIONS
3.1 Prepare the COSEAL Surgical Sealant per the instructions for use provided with that device.
NOTE: Remove surplus air from the syringes.
3.2 Depress the retention clips on the COSEAL Surgical Sealant device and then attach the spray head firmly to the
syringe luers. Release the retention clips and ensure that the spray head is seated properly within the retention clips.
3.3 Fit the pressure line to the lower luer-lock connector of the spray head. Connect the transparent sterile filter at the
other end of the tube to the appropriate connector on the EASYSPRAY Pressure Regulator. Connect the EASYSPRAY
Pressure Regulator to the gas source according to the corresponding IFU.
3.4 Remove the standard syringe clip on the COSEAL Surgical Sealant device, and replace with the EASYSPRAY-Clip
provided with the spray set.
3.5 Connect the blue sterile filter at the other end of the line to the appropriate luer-lock connector (blue ring) on the
EASYSPRAY Pressure Regulator.
3.6 To activate the flow of gas, occlude the opening in the EASYSPRAY-Clip center with thumb. A pressure of 1.5 bar has
proved optimum for spray output.
3.7 If a constant flow of gas is preferred, close the C-clamp on the sensor line. Deactivation of the spray is no longer
possible by removal of the thumb from the clip/plunger. Instead, turn off the gas flow by opening the C-clamp.
3.8 The stream of sterile gas ejected from the spray head can be used to displace the tissue fluid on the operation area,
if necessary, and thus create optimum conditions for the application of COSEAL Surgical Sealant.
3.9 The quantity of COSEAL is controlled by depressing the hole located on the EASYSPRAY-Clip (to activate gas) and
depressing the syringes barrels forward.
3.10 The EASYSPRAY Pressure Regulator will continue to emit gas for a brief period after the thumb is removed from the
EASYSPRAY-Clip/plunger. This delay helps to avoid clogging of the spray head.
3.11 To achieve an optimal result, a spraying distance of 10 – 15 cm is recommended. In specific situations where
spraying at less than 10 cm is necessary, the gas pressure must be reduced appropriately.
See table for recommendations.
Distance
Gas Pressure
4. WARNING
Any application of pressurized gas may be associated with a potential risk of air embolism, tissue rupture or
gas entrapment with compression, which may be life-threatening. Especially in case of low central venous
pressure there is an increased risk of air embolism in vena cava anastomoses. Be sure to take appropriate
measures to exclude these risks, by control of maximum pressure (2 bar) and minimum distance (10 cm).
The C-clamp is not to be utilized when spraying into enclosed body cavities.
The spray set must only be used in connection with the EASYSPRAY Pressure Regulator. DO NOT connect the spray set
directly to the pressurized gas supply. The use of accessories of other manufacturers is not permitted.
Do not re-sterilize
Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to
injury, illness or death of the patient.
5. ACCESSORIES
EASYSPRAY Pressure Regulator
BAXTER and EASYSPRAY are trademarks of Baxter International Inc., its subsidiaries or affiliates.
COSEAL is a trademark of Angiodevice International GmbH, used under licence.
ИНСТРУКЦИЯ ЗА УПОТРЕБА
COSEAL Spray Set
за прилагане на хирургическо лепило COSEAL.
COSEAL Spray Set се употребява с хирургическото лепило COSEAL и
aпарата за регулиране на налягане EASYSPRAY.
1. ОБЛАСТ НА ПРИЛОЖЕНИЕ
Пулверизиращият комплект COSEAL е разработен, за да работи с хирургическото лепило COSEAL и регулатора
на налягане EASYSPRAY за приложение на хирургическото лепило COSEAL върху обширни повърхностни зони.
Неговото използване е особено полезно в случаи, при които нанасянето на равномерен слой фибриново лепило
COSEAL върху големи повърхности е от първостепенно значение.
2. ОПИСАНИЕ
Спрей комплектът се състои от:
2 пулверизиращи глави
1 съединителна тръба с двоен лумен, състояща се от линия за налягане с прозрачен стерилен филтър и от
по-тънка сензорна линия със син стерилен филтър, както и от щипка на EASYSPRAY, която се свързва към
буталото на хирургическото лепило COSEAL за включване на подаването на газ.
2.1 Принцип на действие
В пулверизиращата глава, която е закрепена към системата с двукамерна спринцовка, съдържаща
хирургическото лепило COSEAL, двата разтвора се подават през два съседни изхода. Тези два изходни канала са
обкръжени от херметизирания изход на газа. Газовият поток пулверизира и смесва двата разтвора.
Налягането и дебита на намиращия се под налягане газ се контролират от апарата за регулиране на налягането
v
y
u Système à double seringue
contenant la colle chirurgicale
COSEAL
v Support EASYSPRAY
w embout-pulvérisateur
x Supports de rétention
y Tubulure sous pression
z Tubulure de détection
{ Pince en C
| Filtres stériles
 Dispositif de contrôle de
la pression EASYSPRAY
u Doppelspritzensystem mit dem
chirurgischen COSEAL
Gewebekleber
v EASYSPRAY Clip
w Sprühkopf
x Halteklammern
y Druckleitung
z Messleitung
{ C-Klemme
| Sterilfilter
 EASYSPRAY Druckregler
u Σύστημα διπλής σύριγγας που
περιέχει χειρουργικό
συγκολλητικό ιστών COSEAL
v Σύνδεσμος EASYSPRAY
w Κεφαλή ψεκασμού
x Σύνδεσμοι συγκράτησης
y Γραμμή πίεσης
z Γραμμή αισθητήρα
{ Σφιγκτήρας τύπου C
| Στείρα φίλτρα
 Συσκευή ρύθμισης πίεσης
EASYSPRAY
u Sistema a doppia siringa
contenente il sigillante
chirurgico COSEAL
v Clip EASYSPRAY
w Nebulizzatore
x Supporti di ritenzione
y Condotto di erogazione
z Condotto del sensore
{ Clamp a C
| Filtri sterili
 EASYSPRAY – apparecchio
regolatore di pressione
u Dobbeltsprøytesystem som
inneholder COSEAL kirurgisk
vevslim
v EASYSPRAY-klemme
w Sprayhode
x Holdeklemmer
y Trykkslange
z Sensorslange
{ C-klemme
| Sterile filtre
 EASYSPRAY-trykkregulator
5 cm
1.5 bar / 22 psi
1 bar / 15 psi
recommended
z
{
|
u system dwustrzykawkowy
zawierający klej chirurgiczny
COSEAL
v klamra EASYSPRAY
w głowica rozpylająca
x klamry blokujące
y linia ciśnieniowa
z linia czujnikowa
{ zacisk C
| sterylne filtry
 regulator ciśnienia EASYSPRAY
u Sistema de dupla seringa
contendo Selante Cirúrgico
COSEAL
v Clip EASYSPRAY
w Ponta de pulverização
x Clips de retenção
y Tubo de pressão
z Tubo sensor
{ Clamp C
| Filtros estéreis
 Regulador de pressão
EASYSPRAY
u Sistema de jeringa doble con
sellante quirúrgico COSEAL
v Pinza EASYSPRAY
w Cabezal pulverizador
x Pinzas de retención
y Línea de presión
z Línea sensora
{ Pinza en C
| Filtros estériles
 Regulador de presión
EASYSPRAY
u Dubbelt sprutsystem som
innehåller COSEAL kirurgiskt
vävnadslim
v EASYSPRAY-hållare
w Sprayhuvud
x Hållare
y Tryckslang
z Sensorslang
{ C-klämma
| Sterila filter
 EASYSPRAY tryckregulator
u COSEAL Cerrahi Doku
Yapıştırıcısı içeren Çift Enjektör
Sistemi
v EASYSPRAY Klips
w Püskürtme Kafası
x Tutma Klipsleri
y Basınç Hattı
z Sensör Hattı
{ C Klempi
| Steril Filtreler
 EASYSPRAY Basınç Regülatörü
Manufacturer
Batch number
Use by
Catalogue number
Consult instructions for use
Contains or presence of phthalate:
bis (2-ethylhexyl) phthalate (DEHP)
Keep dry
10 cm
2 bar / 29 psi
BE-30-03-683
C12752

15 cm