nhằm để mô tả chung về sản phẩm vào thời điểm sản xuất và không cấu thành bất kỳ bảo đảm rõ ràng nào.
Nhà Sản Xuất và Nhà Phân Phối sẽ không chịu trách nhiệm về bất kỳ thiệt hại trực tiếp, ngẫu nhiên hoặc do hậu
quả nào do tái sử dụng sản phẩm.
SYMBOLS/СИМВОЛИ/SYMBOLY/
Definition/Определение/Definice/Definitioner/
SYMBOLER/SYMBOLE/ΣΥΜΒΟΛΑ/
Definition/Ορισμός/Definición/Määritelmä/Signification/
SÍMBOLOS/SYMBOLIT/SYMBOLES/
Definicija/Definíció/Definizione/Sąvokos apibrėžimas/
SIMBOLI/JELEK/SIMBOLI/
Definīcija/Definitie/Definisjon/Definicja/Definição/
SUTARTINIAI ŽENKLAI/SIMBOLI/
Определение/Definícia/Дефиниција/Definition/Tanım/
SYMBOLEN/SYMBOLER/SYMBOLE/
Визначення/Định Nghĩa
SÍMBOLOS/СИМВОЛЫ/SYMBOLY/
ОЗНАКЕ/SYMBOLER/SEMBOLLER/
СИМВОЛИ/BIỂU TƯỢNG
Femoral
Бедрена
Femorální
Vena femoralis
Femoral
Μηριαία
Femoral
Reisi
Fémorale
Femoralno
Femoralis
Femorale
Šlaunies
Femorālā piekļuve
Femoraal
Femoral
Udowy
Femoral
Бедренная вена
Stehenný
Феморални
Femoral
Femoral
Стегновий
Phần đùi
SYMBOLS/СИМВОЛИ/SYMBOLY/
Definition/Определение/Definice/Definitioner/
SYMBOLER/SYMBOLE/ΣΥΜΒΟΛΑ/
Definition/Ορισμός/Definición/Määritelmä/Signification/
SÍMBOLOS/SYMBOLIT/SYMBOLES/
Definicija/Definíció/Definizione/Sąvokos apibrėžimas/
SIMBOLI/JELEK/SIMBOLI/
Definīcija/Definitie/Definisjon/Definicja/Definição/
SUTARTINIAI ŽENKLAI/SIMBOLI/
Определение/Definícia/Дефиниција/Definition/Tanım/
SYMBOLEN/SYMBOLER/SYMBOLE/
Визначення/Định Nghĩa
SÍMBOLOS/СИМВОЛЫ/SYMBOLY/
ОЗНАКЕ/SYMBOLER/SEMBOLLER/
СИМВОЛИ/BIỂU TƯỢNG
Jugular
Югуларна
Jugulární
Vena jugularis
Jugular
Σφαγιτιδική
Yugular
Kaula
Jugulaire
Jugularno
Juguláris
Giugulare
Jungo
Jugulārā piekļuve
Jugularis
Jugular
Szyjny
Jugular
Яремная вена
Krčný
Југуларни
Jugular
Jugüler
Яремний
Cổ
English:
The symbols glossary is located electronically at
www.argonmedical.com/symbols
Речникът на символите се намира в електронен вид
Bulgarian:
на адрес www.argonmedical.com/symbols
Slovníček symbolů v elektronické podobě se
Czech:
nachází na www.argonmedical.com/symbols
Listen over symboler findes elektronisk på
Danish:
www.argonmedical.com/symbols
Sie finden das Symbolglossar elektronisch unter
German:
www.argonmedical.com/symbols
Greek:
Το γλωσσάρι των συμβόλων βρίσκεται στην ηλεκτρονική
διεύθυνση www.argonmedical.com/symbols
El glosario de símbolos, en formato electrónico, se encuentra en
Spanish:
www.argonmedical.com/symbols
Elektroninen symbolikirjasto on osoitteessa
Finnish:
www.argonmedical.com/symbols
The Option™ ELITE Filter may be removed according to the instructions supplied in the Section IX, enti-
tled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter
can only be performed by the jugular approach.
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement
of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
III. Contraindications
The Option™ ELITE Filter should not be implanted if any of the following conditions are present:
1. Patient has an inferior vena cava diameter larger than 32mm.
2. Patient is at risk for septic embolism.
3. Patient has confirmed bacteremia.
4. Patient has a known hypersensitivity to nickel or titanium alloys.
5. Pregnant patient when radiation from fluoroscopic imaging may endanger the
fetus. Risks and benefits should be carefully assessed.
There are no known contraindications for use of the Angiographic Vessel Dilator.
IV. Warnings:
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged.
w For single product and patient use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing
or re-sterilization 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 re-sterilization 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. Accordingly, the
Manufacturer or its Distributors will not be responsible for any direct or consequential damages or
expenses resulting from reuse, reprocessing or re-sterilization of any of the components in the Option™
ELITE Filter introduction kit.
w Non-clinical testing has demonstrated that the Option™ ELITE Filter is MR Conditional. A patient with
the Option™ ELITE Filter can be safely scanned immediately after placement under the following
conditions:
– Static magnetic field of 3 Tesla
– Spatial gradient magnetic field of 720 Gauss/cm
– Maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15min of scanning
In non-clinical testing, the Option™ ELITE Filter produced a temperature rise of less than or equal to
1.7
0
C at a maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes
of MR scanning in a 3.0 Tesla General Electric Healthcare MR scanner. The SAR calculated using
calorimetry was 2.8 W/kg. MR image quality may be compromised if the area of interest is in the exact
same area or relatively close to the position of the Option™ ELITE Filter. Therefore, it may be necessary
to optimization of MR imaging parameters to compensate for the presence of this metallic implant.
w When injecting contrast medium through the Angiographic Vessel Dilator, do not exceed the maximum
pressure rating of 800 psi.
w After filter implantation, any catheterization procedure requiring passage of a device through the filter
may be impeded.
w The Option™ ELITE Filter is supplied loaded in a cartridge indicating the appropriate orientation for
femoral and jugular approaches. Never reload a fully ejected filter into the Cartridge as this could
affect its shape and function and could result in incorrect filter orientation for the selected access site.
Never reload a (partially) ejected filter into the cartridge as this could affect its shape and function.
Accordingly, the Manufacturer or its Distributors will not be responsible for any direct, incidental or
consequential damages resulting from replacement of the Option™ ELITE Filter in the cartridge.
w The Option™ ELITE Filter should only be used by physicians who are trained in diagnostic and
percutaneous interventional techniques, such as placement of vena cava filters. Accordingly, the
Manufacturer or its Distributors will not be responsible for any direct or consequential damages or
expenses resulting from use by untrained personnel.
w Persons with allergic reactions to nickel-titanium alloys (Nitinol) may suffer an allergic response to this implant.
w Never advance the guidewire, introducer sheath/dilator or deploy the filter without fluoroscopic guidance.
w If large thrombus is observed at the initial delivery site, attempt filter delivery through an alternative
site. A small thrombus may be bypassed with the guidewire and introducer.
w Never redeploy a malpositioned or retrieved filter.
w For the standard procedure, once the Option™ ELITE Filter is advanced into the sheath, do not retract
then re-advance the Pusher, which may cause premature deployment of the filter.
w For the standard procedure, once the Pusher delivery marker enters the metal tube of the Filter Car-
tridge, the filter must be fully deployed and it cannot be re-sheathed.
w For the Over-the-Wire procedure, once the Dilator delivery marker enters the metal tube of the Filter
Cartridge, the filter must be fully deployed and it cannot be re-sheathed.
For Optional Filter Retrieval:
w Excessive force should not be used to retrieve the filter.
w Retrieval of the filter should not be attempted if thrombus is present in the filter, IVC or deep veins.
w Retrieval of the filter is possible only from the jugular approach. Before attempting retrieval of the filter
from the jugular access site, verify that the filter retrieval hook is oriented in a cephalad direction –
i.e. pointed toward the jugular access site. The retrieval hook at the cephalad end of the filter is the
location for endovascular snare engagement.
w Retrieval of the filter should only be performed by physicians who are trained in percutaneous
interventional techniques.
w Never redeploy a retrieved Filter.
w Please refer to Section IX labeled "Optional Procedure for Filter Retireval".
V. Precautions
w Physicians should be properly trained prior to using the Option™ ELITE Vena Cava Filter.
w Store in a cool, dark, dry place.
w Do not use if package is open or damaged.
w Use prior to "Use By" date.
w Do not autoclave or resterilize.
w Do not continue to use any component damaged during the procedure.
w If strong resistance is met during any stage of the procedure, discontinue the procedure and determine
the cause before proceeding.
w The Option™ ELITE Filter has been tested and qualified with the accompanying or recommended
accessories. The use of any other accessory could result in complications and/or an unsuccessful
procedure.
w Anatomical variances may complicate Filter insertion and deployment. Careful attention to these
Instructions for Use can shorten insertion time and reduce the likelihood of difficulties.
w Spinal deformations: It is important to exercise care when contemplating implantation in patients with
significant kyphoscoliotic spinal deformations because the inferior vena cava may follow the general
course of such anatomic deformations.
