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Grafts and Fistulae
INDICATIONS FOR USE:
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The CLEANER 15
Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and
synthetic dialysis access grafts.
CONTRAINDICATIONS:
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The CLEANER 15
Rotational Thrombectomy System is contraindicated in the following:
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When in the medical judgment of the physician, such a procedure may compromise the patient's condition.
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In native vessels smaller than 6mm in diameter
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Existing hemodialysis access site infection.
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Immature native vessel dialysis fistulae (fistulae that have not been used for at least one hemodialysis treatment).
WARNINGS AND PRECAUTIONS:
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Prior to use, read all package insert warnings, precautions, and instructions. Failure to do so may result in severe patient injury
and death.
-
These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved. The
device has been sterilized by EtO and is sterile unless the package is opened or damaged. The package should be examined
before use; if damaged, DO NOT USE. The device is intended for single patient use only; DO NOT REUSE OR RE-STERILIZE.
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Prior to use, carefully examine the CLEANER 15
shipment. If the product components show any sign of damage, DO NOT USE.
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Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care workers should
routinely use universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to
during any handling of the device.
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Practitioners must be aware of potential complications associated with dialysis fistula and graft thrombolysis including:
•
Hemorrhage
Symptomatic pulmonary embolism
•
•
Arterial embolization
•
Allergic reaction to contrast media
•
Pseudoaneurysm
•
Pain and/or tenderness
-
Caution should be used when dislodging the plug at the arterial anastomosis to minimize the risk of arterial embolization.
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Due to the lack of excretion associated with hemodialysis patients, use of contrast should be kept to a minimum throughout this
procedure.
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Potential fatigue failure of the CLEANER 15
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sinuous wire may occur with prolonged activation of the CLEANER 15
withdrawal rate of 1-2 cm/second is recommended when sharp radii are encountered (i.e. radius of a loop graft or fistula, radii <
3 cm).
A SUGGESTED PROCEDURE:
Use sterile technique.
Patient Preparation:
1.
Premedicate with appropriate anxiolytic, analgesic and/or antibiotic per hospital protocol.
Device Performance Testing:
2.
Remove the CLEANER 15
™
Rotational Thrombectomy System from the package. Press the ON/OFF switch to ensure that the
sinuous wire spins freely (refer to Figure 2). Release the switch to stop the rotator. Precaution: Do not use the device if it
does not activate immediately when the switch is pressed, and deactivate immediately when the switch is released.
3.
Flush the CLEANER 15
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catheter with heparinized saline through the catheter lumen flush port. Return the stopcock to the off
position prior to operation.
Thrombolysis Procedure:
4.
Complete the CLEANER 15
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thrombolysis procedure under continuous fluoroscopy. Do not initiate sinuous wire rotation (device
activation) unless proper device positioning is confirmed within the fistula or graft.
5.
Prepare and drape the puncture site as required.
6.
Administer local anesthetic at the puncture site for venous sheath insertion.
7.
Select an appropriately sized sheath to accommodate the CLEANER 15
during the procedure. Maximum guidewire size will be dependent upon the introducer sheath/dilator assembly chosen.
8.
Prepare and place the venous introducer sheath per hospital protocol. The venous sheath should be placed in the venous limb
of the graft, and directed toward the venous anastomosis. In fistulae, the venous sheath placement can be optional depending
on the clot burden in the vessel. If a venous sheath is used, it should be placed in the venous limb of the fistula and directed
toward the central venous outflow. Note: If no venous sheath is used in the AV fistula, then go to step 16.
Rotational Thrombectomy System to verify that it has not been damaged during
•
Vessel tear or disruption
Infection
•
•
Perforation of the artery or vein
•
Hematoma
•
Death
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catheter and other devices/ catheters that may be used
5
UYARI:
Sadece tek kullanımlıktır. Yeniden kullanmayın, yeniden işlemeyin veya yeniden sterilize etmeyin. Yeniden kullanma, yeniden
işleme veya yeniden sterilize etme cihazın yapısal bütünlüğünü bozabilir ve/veya cihazın arızalanmasına ve bunun sonucunda
hastanın yaralanmasına, hastalanmasına veya ölmesine sebep olabilir. Yeniden kullanma, yeniden işleme veya yeniden sterilize etme
ayrıca cihazda kontaminasyon riskine ve/veya bir hastadan diğerine bulaşıcı hastalık geçmesi dahil ancak bununla sınırlı olmamak
üzere hastada enfeksiyona veya çapraz kontaminasyona da yol açabilir. Cihazın kontamine olması hastanın yaralanmasına,
hastalanmasına veya ölmesine sebep olabilir.
SAKLAMA:
Kontrollü oda sıcaklığında saklayın. Organik solventlere, iyonizan radyasyona veya ultraviyole ışınlarına maruz bırakmayın.
ATMA İŞLEMİ:
Kateter sistemini Atık Elektrikli Ve Elektronik Cihazlar Yönergesine (WEEED) ve kanla temas eden tek kullanımlık cihazlar dahil olmak
üzere tıbbi atıklar hakkındaki standart kuruluş prosedürlerine göre atın.
GARANTİNİN REDDİ VE SORUMLULUĞUN SINIRLANDIRILMASI:
Bu belgede açıklanan Argon Medical ürünlerinin ticarileştirilebilirliği veya belirli bir amaca uygunluğu ile ilgili örtülü garantiler dahil
ancak bunlarla sınırlı olmamak üzere hiçbir açık ya da örtülü garanti verilmez. Argon Medical, ilgili yasalarca açıkça belirtilenler dışında
hiçbir koşulda doğrudan, tesadüfi ya da sonuç olarak ortaya çıkan hasarlardan sorumlu tutulamaz. Hiç kimse, burada açıkça belirilenler
dışında Argon Medical'i bağlayıcı bir garanti veya beyanda bulunma yetkisine sahip değildir.
Bu belge dahil olmak üzere Argon Medical'in basılı materyallerinde yer alan açıklama veya teknik özellikler sadece üretim zamanı
itibariyle ürünü genel olarak açıklama amacına yönelik olup hiçbir şekilde açık garanti yerine geçmez.
Argon Medical, ürünün yeniden kullanılmasından kaynaklanan doğrudan, tesadüfi ya da sonuç olarak ortaya çıkan hasarlardan
sorumlu tutulamaz.
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device. A
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