Medrad AngioJet Ultra, Руководство по эксплуатации

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A bag of sterile, heparinized saline (not included) supplies the pump with
saline through the saline delivery tubing. The pump pressurizes the saline.
The Thrombectomy Set uses this pressurized, high-velocity saline to create
a low-pressure zone at the catheter tip. This allows the catheter to break up
and remove thrombus. The waste tubing transports the thrombus debris
from the catheter to the collection bag for ultimate disposal.
The Console is intended for use only in conjunction with an AngioJet Ultra
Thrombectomy Set. Refer to the individual Thrombectomy Set Information
for Use manual for specific clinical applications.
Refer to the individual Thrombectomy Set Information for Use manual for
specific contraindications.
• The AngioJet Ultra System should be used only by operators who have
received appropriate training on its installation and use.
• Use the AngioJet Ultra Console only with an AngioJet Ultra
Thrombectomy Set. This Console will not operate with a previous
model pump set and catheter.
• Do not attempt to bypass any of the Console safety features.
• If the catheter is removed from the patient and/or is inoperative, the
waste tubing lumen, guide catheter, and sheath should be flushed with
sterile, heparinized solution to avoid thrombus formation and maintain
lumen patency. Reprime the catheter by submerging the tip in sterile,
heparinized solution and operating it for at least 20 seconds before
reintroduction to the patient.
• Physician discretion with regard to the use of heparin is advised.
• Refer to the individual AngioJet Ultra Thrombectomy Set
Information
for Use manual for specific warnings and precautions.
• Do not move the collection bag during catheter operation as this may
cause a collection bag error.
• Monitor thrombotic debris/fluid flow exiting the catheter through
the waste tubing during use. If blood is not visible during console
activation, the catheter may be occlusive within the vessel or the
outflow lumen may be blocked.
• Ensure adequate patient anticoagulation to prevent thrombus
formation in outflow lumen.
• Refer to individual Thrombectomy Set Instructions for Use manual for
specific instructions regarding heparinization of the Thrombectomy Set.
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2. INDICATIONS AND USAGE
3. CONTRAINDICATIONS
4. WARNINGS AND
PRECAUTIONS