ev3 CELLO Gebrauchsanweisung Seite 5

Precautions
 Single use only. (If the product is to be re-used, it may cause
infection to patients or damage to the product.)
 Store in a cool, dry, dark place.
 Do not use open or damaged packages.
 Use by "Use By" date.
 Exposure to temperatures above 54°C (130°F) may damage the
device and accessories. Do not autoclave.
 Upon removal from package, inspect the device to ensure it is
not damaged.
 Do not expose the device to solvents.
 Do not use oily contrast media, consisting of ethyl ester of
iodinated poppy-seed oil fatty acids, such as Lipiodol.
 The guidewire used with this system should incorporate a
hydrophilic coating.
 Use the device in conjunction with fluoroscopic visualization and
proper anticoagulation agents.
 Do not conduct MRI inspection while the product is in place.
 Torquing the guide catheter while kinked may cause damage that
could result in separation of the catheter shaft.
 If a device becomes lodged in the guide catheter, or if guide
catheter becomes severely kinked, withdraw the entire system
(guide catheter, guidewire and catheter sheath introducer).
 To prevent thrombus formation and contrast media crystal
formation maintain a constant infusion of appropriate flush
solution through the guide catheter lumen.
 After use, dispose of this product and packaging based on the
hospital, administrative and /or local government policy.
 If user and/or patient notice any serious incident that has
occurred in relation to the device, please report to the
manufacturer and the competent authority.
Recommended Procedure
1. Gently remove the catheter from the pouch by grasping the
hub and slowly pulling the catheter straight out of the
protective tubing without bending the shaft. Inspect the
catheter before use to verify that its size, shape and condition
are suitable for the specific procedure.
2. Dilator Instructions (if applicable):
 Remove dilator from protective tube.
 Gently insert dilator into guide catheter lumen.
 Flush dilator with heparinized saline.
3. Prepare balloon inflation media by mixing contrast with saline
(50% by volume or equivalent to 150 mg/mL iodine).
4. Fill a 20 mL syringe with 5 mL of balloon inflation media. Attach
a 3-way stopcock to the balloon hub. Attach a 20 mL syringe to
the stopcock.
5. Attach a 1 mL syringe to the balloon's 3-way stopcock. Turn the
stopcock towards the 1 mL syringe.
6. With the 20 mL syringe pointing downward:
 Pull back on the syringe plunger to aspirate the balloon lumen.
Maintain negative pressure until the air bubbles stop forming
in the syringe.
 Release the syringe plunger to allow media to be drawn into
the balloon lumen. Do not infuse media.
 Again pull back on the syringe plunger to aspirate the balloon
lumen. Maintain negative pressure until air bubbles stop
forming in the syringe.
 Release the syringe plunger to allow media to be drawn into
the balloon lumen. Do not infuse media.
7. Turn stopcock towards the balloon hub. Transfer maximum
recommended balloon inflation volume from the 20 mL syringe
to the 1 mL syringe.
8. Inflate the balloon up to the recommended inflation volume.
Refer to the product label. Turn the stopcock off towards the
balloon hub.
9. Inspect the balloon for leakage. Keep the balloon inflated until
the air bubbles diffuse from the balloon. If air remains in the
balloon, it should dissipate if left in a sterile field for several
minutes.
10. Deflate the balloon by turning stopcock towards the 1 mL
syringe and aspirating with the 20 mL syringe.
11. After ensuring that the balloon is fully deflated, wet the distal
shaft with saline and insert the balloon portion of the catheter
into the inserter.
12. Gently insert the tip of the guidewire and the inserter/guide
catheter assembly through the proximal valve of the introducer
sheath.
13. During insertion of the catheter, when the balloon passes the
sheath inducer, pull back the inserter only and peel it away
from the catheter.
14. Place the guide catheter in the selected vessel using
fluoroscopy.
15. Remove dilator (if applicable) and guidewire.
16. Attach a rotating hemostatic valve (RHV) to the guide catheter
through-lumen hub. Flush the through-lumen with heparinized
saline. Attach a 3-way stopcock to the RHV and to appropriate
flush solution.
17. To inflate the balloon, transfer up to the maximum
recommended balloon inflation volume from the 20 mL syringe
to the 1 mL syringe and gently infuse the balloon inflation
media with the 1 mL syringe until desired balloon diameter is
attained.
18. Ensure the balloon is completely deflated before withdrawing
the guide catheter.
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