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Indication for use
The product is for single step drainage of cysts, gall
bladders and nephrostomies.
Duration
Up to 12 weeks
Warnings
This device was designed, tested and manufactured
for single use only. Reuse or reprocessing has not
been evaluated and may lead to its failure and
subsequent patient illness, infection or other
injury. Do not reuse, reprocess or re-sterilize this
device.
Do not use if package appear open or if the expiry
date has been exceeded.
During insertion avoid contact with bone, cartilage
and scar tissue which can damage the catheter tip.
The product must only be used by qualified
personnel who are familiar with the technique.
Preparation
Advance the straightener carefully over the
curvature of the catheter, while straightening the
curvature with your fingers.
Gently pull the thread to lock the pigtail in order to
avoid unintentional looping of the thread.
Introduce the metal stiffener fully with the trocar
needle slightly drawn back to avoid damaging the
catheter wall.
Fasten the stiffener onto the catheter and introduce
the trocar needle. Support the tip of the catheter
advancing the needle. Snap the Choice Lock™ onto
the stiffener hub.
Remove the straightener and the catheter is now
ready for use.
Activate the coating by saline.
Procedure
Single-step catheterisation through a skin incision.
Perform the skin incision under local anaesthesia.
Introduce the catheter set to the cavity using
ultrasound guidance, CT or fluoroscopy.
Verify correct position by releasing the Choice Lock™
with one hand and remove the stylet. Check that
fluid is escaping or aspirate with a 10 ml syringe.
The stylet must always be correctly positioned if you
want to change the placement. When correctly
positioned advance the catheter over the needle,
holding the needle steady.
Ensure that the complete length of the pigtail is in
the cavity.
Gently pull the thread turning the catheter counter
clockwise to ensure correct position and to complete
curvature.
While pulling the thread tightly fasten the lilac
male/female adapter onto the catheter hub. The
male luer activates the "string valve".
Connect the catheter to a drainage bag using a
suitable connecting tube.
Fix the thread tightly by winding it around the slot in
the adaptor and finish up with pressing the clip onto
the slot and twist off the handle from the clip.
SKATER™ Single Step Drainage Set – Locking
2 / 22
It is recommended affixing the catheter in a straight line
and that any curvature be applied to the connecting tube.
It is recommended that the physician follow the
hospital's standard of care procedures for drainage
catheters.
Removal of catheter
Disconnect the drainage bag connector tube from
catheter.
Loosen the female/male adaptor from the standard
luer hub at the catheter to deactivate the valve.
Remove the clip and unwind the suture. Check that
both threads are loose and cut one thread in order to
loosen the pigtail.
Pull the catheter out gently. If access is to be
maintained, a straight floppy tip guidewire passed
through the catheter will facilitate removal while
maintaining access.
Caution
If the catheter is to be removed on another ward, we
recommend that these guidance notes accompany the
patient's case notes to ensure that the relevant
personnel are aware of the presence of a locking
catheter. It is also advisable to inform the patient.
Storage
Store in a dark, dry, cool place. Avoid extended exposure
to light.
Do not re-use
Consult Instruction For Use
Use by
Batch code
Catalogue number
Sterilized using ethylene oxide
Do not use if package is damaged
Quantity
Manufacturer
CE mark and identification number
0086
of notified body. Product conforms
to the essential requirements of
The Medical Device Directive
93/42/EEC
bg - Български
Показания
Продуктът е предназначен за едноактен дренаж на
кисти, жлъчни мехури и нефростомии.
Продължителност
До 12 седмици
Предупреждения
Това изделие е проектирано, тествано и
произведено само за еднократна
употреба. Повторното използване или обработка
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