Описание На Устройството - ProStar XL Manual Del Usuario

6 . Insert a 0 .038" (0 .97 mm) (or smaller) guide wire into
the Guide Wire Exit Port and replace the Prostar XL
device with another Prostar XL device, an introducer
sheath, or utilize conventional compression therapy . If a
guide wire straightener is used to reinsert the guide wire,
care must be taken to avoid disturbing the hemostasis
valve located in the device just distal to the guide wire
exit port .
Post ProceDure PAtIent MAnAGeMent
1 . Apply an appropriate dressing to the puncture site .
2 . Assess the insertion site as per hospital protocol .
coMPLIcAtIons
Potential complications resulting from procedures associated
with the use of the Prostar XL PVS System include, but are
not limited to:
• Localized vessel wall trauma which may lead to surgical
repair
• Arterial thrombus
• Deep vein thrombosis
• Pseudoaneurysm
• Hematoma
• Local infection
• Nerve injury
• Local pulse deficits or ischemia
• Blood loss that may lead to blood transfusion
• Local discomfort
• Wound dehiscence .
recoMMenDAtIon for PAtIent AMBuLAtIon AnD
DIscHArGe
1 . Patients may be ambulated after Prostar XL device
procedures with normalized (150–180 seconds) Activated
Clotting Times (ACTs) .
2 . Patients who have undergone Prostar XL device
procedures may be eligible for earlier discharge from
the hospital relative to conventional compression (i .e .,
manual or mechanical methods) .
3 . Before considering early discharge, assess for the
following clinical conditions:
• Conscious sedation
• Anticoagulation, thrombolytic or antiplatelet therapy
• Unstable cardiac status
• Hematoma at the closure site
• Hypotension
• Pain while walking
• Bleeding at the closure site
• Any comorbid condition requiring observation .
The presence of any of the above factors has generally
led to the deferral of early discharge recommendations .
ProDuct InforMAtIon DIscLosure
Abbott Vascular Inc . has exercised reasonable care in the
manufacture of this device . Abbott Vascular Inc . excludes
all warranties, whether expressed or implied, by operation
of law or otherwise, including but not limited to, any implied
warranties of merchantability or fitness, since handling and
storage of this device, as well as factors relating to the
patient, diagnosis, treatment, surgical procedures, and other
matters beyond the control of Abbott Vascular Inc . directly
affect this device and the results obtained from its use .
Abbott Vascular Inc . shall not be liable for any incidental or
consequential loss, damage, or expense, directly or indirectly
arising from the use of this device . Abbott Vascular Inc .
neither assumes, nor authorizes any other person to assume
for it, any other or additional liability or responsibility in
connection with this device .
RELEASED
HoW suPPLIeD
Prostar XL Percutaneous Vascular surgical system
The Prostar XL PVS device and accessories are provided
sterile and non-pyrogenic in unopened undamaged packages .
Products are sterilized with ethylene oxide and intended for
single use only . This single use device cannot be reused on
another patient, as it is not designed to perform as intended
after the first usage . Changes in mechanical, physical,
and / or chemical characteristics introduced under conditions
of repeated use, cleaning, and / or resterilization may
compromise the integrity of the design and / or materials,
leading to contamination due to narrow gaps and / or spaces
and diminished safety and / or performance of the device .
Absence of original labeling may lead to misuse and eliminate
traceability . Absence of original packaging may lead to device
damage, loss of sterility, and risk of injury to the patient
and / or user . Do not resterilize . Store in cool, dry place .
PAtents AnD trADeMArKs
This product and / or its use may be covered by one or
more of the following United States Patents: 5,417,699;
5,527,322; 5,613,974; 5,746,755; 5,779,719; 5,792,152;
5,797,929; 5,860,991; 5,902,311; 5,921,994; 6,036,699;
6,117,145; 6,206,893; 6,355,050; 6,517,553; 7,029,480;
7,445,626; EP 673228; EP 727965; EP 910288; EP
1236437 . Other U .S . patents pending . Foreign patents
issued and pending .
Prostar and Perclose are trademarks of the Abbott Group of
Companies .
Please refer to the end of this booklet for Graphical
symbols for Medical Device Labeling.
ПЕркУТаННа съДОВа ХирУргиЧНа сисТЕМа (PVs)
За ОсигУрЯВаНЕ На ПраВилНО ПрилОЖЕНиЕ и
раБОТа с ТОВа УсТрОЙсТВО и За ПрЕДОТВраТЯВаНЕ
На НараНЯВаНЕ На ПаЦиЕНТи ПрОЧЕТЕТЕ ЦЯлаТа
иНФОрМаЦиЯ, съДърЖаЩа сЕ В ТЕЗи иНсТрУкЦии
За УПОТрЕБа.
ВНиМаНиЕ
Устройството трябва да се използва само от лекари (или
други здравни специалисти, оторизирани или ръководени
от такива лекари), които са обучени в диагностична
и терапевтична катетеризация и които са обучени от
оторизиран представител на Abbott Vascular .
Преди работа операторът трябва да прегледа
Инструкциите за употреба и да е запознат с техниките на
приложение, свързани с употребата на това устройство .
ОПисаНиЕ На УсТрОЙсТВОТО
Перкутанното съдово хирургично устройство Prostar XL
PVS е проектирано да подава полиестерен конец (конци)
за затваряне на пункционните места на феморалната
артерия след катетеризации . Устройството Prostar XL има
два конеца и четири игли .
Устройството Prostar XL се състои от дезиле, което съдържа
двойки игли с конец, иглов водач, който контролира
прецизното разполагане на иглите около пункционното
място, и въртящ се цилиндър, в който влизат иглите .
Дезилетата на Prostar XL са с J-образни върхове на
дисталния край .
7
Each System Includes:
One (1) Prostar XL Percutaneous Vascular Surgical
device
One (1) Perclose Knot Pusher
Български
ProstAr XL
иНсТрУкЦии За УПОТрЕБа