IHT Cordynamic Hunter Bedienungsanweisung Seite 3

7. Form of administration
Sterile: This product is sterilised with ethylene oxide and is pyrogen-free. For single use. Do not use if the packaging is not intact.
Contents: A Hunter thrombus extraction catheter.
A basket filter
A one-way valve
Extension line with attached stopcock
2 syringes with locking plunger
A handbook with instructions for use
Storage: Keep at room temperature, in a dry, cool place, protected from light.
Instructions for disposal: After use, dispose of the device and its package following hospital, administrative or local government rules.
8. Instructions for the operator
Carefully examine all equipment to be used before starting the procedure, including verifying that the catheter is working properly. To do this, you can
inject a small amount of sterile saline solution and verify that it easily exits the distal hole and that there are no leaks at any of the catheter connections.
Observe possible damage to the product packaging and discard those packages that are not in perfect condition. These instructions only provide
technical information and do not eliminate the need for formal training.
1. Prepare a syringe with the recommended contrast medium following manufacturer instructions.
2. Preparation of the Cordynamic® Hunter extraction catheter
2.1. Carefully remove the catheter from the dispenser in order not to damage it.
2.2. Remove the probe to check that the catheter is in good condition.
2.3. Place the catheter into sterile saline solution in order to activate the hydrophilic coating
2.4. If necessary, purge the catheter by injecting a sterile saline solution through it, verifying that the liquid exits through the distal hole. Remove
the syringe from the catheter's luer connector.
2.5. Connect the syringe containing neat contrast medium to the device's luer connector.
3. Insertion technique
3.1. Insert the introducer and the guide catheter by means of the standard techniques recommended in the manufacturer's instructions for use.
3.2. Insert the angioplasty guide through the guide catheter and place it at the lesion site using the standard techniques recommended in the
manufacturer's instructions for use.
3.3. Before introducing the guide through the distal end of the catheter, irrigate its opening with sterile saline solution. Then introduce the guide
from the distal end ensuring that the guide exits the groove located approximately 15 cm from the distal end. This operation may require
straightening the catheter in order to facilitate the passage of the guide. Stretch the guide proximally, keeping its distal end within the catheter
for protection.
Place the haemostatic adapter of the guide catheter (with the rotating joint) on the Cordynamic Hunter catheter, and move the adapter forward
approximately 40 cm towards the barrel of the catheter. Push the catheter forward onto the angioplasty guide. In the event of resistance, do
not move the catheter forward through the adapter. Do not allow the haemostatic adapter to damage the catheter barrel as this could later
influence its properties, such as its ability to pass through the lesion.
3.4. Aspirate and empty the guide catheter completely in preparation of the introduction of the Cordynamic Hunter catheter.
3.5. Connect the side output of the guide catheter's haemostatic adapter to the infusion line to allow the registration of proximal pressure or
infusion by means of the guide catheter. Empty completely.
3.6. Carefully introduce the Cordynamic Hunter catheter into the guide catheter's luer stopcock.
3.7. Push the catheter forward with the aid of the guide. If there is any kind of resistance, stop moving the catheter forward and do not continue
until fluoroscopically determining the cause.
3.8. Use a contrast solution injection to confirm the location of the tip of the guide catheter and place the catheter in the correct position.
3.9. Move the extraction catheter forward on the guide to the tip of the guide catheter. Try not to rotate or bend the catheter around the guide
catheter to prevent damaging it.
3.10. Once outside of the guide catheter, the extraction catheter can be viewed easily due to its radiopaque markers. Move the catheter forward
on the angioplasty guide to the lesion area and cross it. Ensure that the stenosis has been crossed by the injection of contrast liquid through
the extraction catheter.
3.11. A "dotter" effect may occur once it has been crossed in which the lesion may remain dilated to a sufficient diameter to allow the placing of
a stent.
3.12. Through the distal hole located at the most proximal marking, inject the medication required to prepare microcirculation and prevent the
thrombus.
3.13. If the thrombus is visible and must be extracted, connect the extraction syringe and proceed as follows:
ONCE EXTRACTION HAS BEGUN, THE CATHETER CANNOT BE RE-USED TO IRRIGATE CONTRAST MEDIUM OR MEDICINAL
PRODUCTS UNLESS IT IS EXTRACTED FROM THE PATIENT AND APPROPRIATELY CLEANED BY IRRIGATING SALINE SOLUTION
THROUGH ITS EXTRACTION LUMEN UNTIL THERE ARE NO THROMBI LEFT INSIDE.
3.13.1. With the shutoff cock in the "OFF" (closed) position, pull the syringe piston back until it reaches the marking for the intended extraction
volume. Rotate the piston to fix the syringe in the vacuum position.
3.13.2. Check the catheter position by fluoroscopic vision and open the shutoff cock to start the extraction. Push the catheter forward distally.
Blood will enter the syringe until there is no space left. If aspiration does not fill the syringe, extract the catheter from the patient,
irrigate the extraction lumen and re-introduce it into the vasculature.
3.13.3. Having finished the extraction procedure, place the shutoff cock in the "OFF" position and start withdrawing the catheter.
3.14. In order to perform the withdrawal, place the distal portion of the extraction catheter on the lesion and, with the aid of the radiopaque markers,
estimate the length of the stent necessary to cover the lesion.
3.15. Remove the catheter completely. Keep the guide in the stenosis.
3.16. Perform an angiography through the guide catheter to estimate whether or not the use of a dilatation balloon is required.
3.17. Keep the guide in the stenosis and move a pre-assembled stent forward. Dilate the stent on the lesion following manufacturer instructions.
Having dilated the stent, remove the balloon slightly and keep the guide in the dilated stenosis for 10 minutes after the angioplasty. When
the dilation confirms the angiography, carefully remove the guide and balloon catheter through the connector.
3.18. Extract the guide catheter through the introducer
3.19. Leave the introducer in situ until the haemodynamic profile returns to normal.
4. Procedure for catheter exchange
To change a catheter in the event of introducing a balloon dilatation catheter or the stent itself, the fast exchange catheter by Iberhospitex is designed
to allow a fast exchange by a single operator. To exchange catheters:
4.1. Loosen the thread of the haemostatic valve.
4.2. Hold the guide and the haemostatic valve with one hand and the extraction catheter in the other hand.
4.3. Keep the guide in position in the coronary artery. With the guide in a fixed position, remove the catheter from the guide catheter.
4.4. Remove the catheter until reaching the opening in the lumen of the guide catheter (approximately 15 cm from the tip). Carefully remove the
distal portion of the catheter, maintaining the guide at the lesion site. Close the haemostatic valve.
4.5. Prepare the new device to be used as described above.
4.6. Load the new device into the guide. Ensure that the proximal end of the guide exits the catheter groove some 15 cm from the distal tip.