Abbott Agilis HisPro DS3H010-38, Instructions For Use Manual

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Storage and Handling
Handle with care. Items should be stored at temperatures between -20ºC (-4ºF) and 50ºC (122ºF). Store in a well-ventilated area
under conditions that protect items from extreme humidity. In addition, cartons containing these items should be protected from
water and should not be crushed. Do not remove from outer box.
Packaging and Shelf-Life
The catheter packaging is designed to prevent crushing of the product, to minimize product exposure to the atmosphere, and to
provide for aseptic product transfer. It is recommended that the product remain in the unopened package until time of use. Contents
are sterile if the package is unopened and undamaged. Do not resterilize. The expiration date is marked on the outside of the
package. Dispose of used product and packaging following standard solid biohazard waste procedures.
Instructions for Use
Preparing the Catheter
1. Review the label carefully for product identification. Do not use if the device is expired.
Note: International formatting has been used for the expiration date (YEAR-MONTH-DAY)
2. Inspect the package prior to use. Do not use if the package is opened or damaged.
3. Remove the components of the sterile package within the sterile field.
4. Inspect the catheter and both distal tip electrodes for integrity and overall condition. Do not use if the catheter is damaged.
5. Verify that the catheter deflects properly by rotating the deflection knob clockwise (see figure below). Do not use if the catheter
is damaged.
6. Turn the deflection knob counterclockwise to the neutral position.
Note: After the catheter has been deflected, the catheter shaft may not return to a fully straight position.
7. Connect the three-way stopcock to the luer fitting prior to flushing the catheter (Figure 1). Luer fitting is specifically for fluid, do
not use luer port for guide wire delivery.
CAUTION: Catheter should be flushed with the stopcock attached.
8. Flush the catheter with normal saline or heparinized saline via the stopcock. Close the stopcock.
9. Flush the dilator with normal saline or heparinized saline.
10. Insert the dilator into the hemostasis valve and advance the dilator until it extends beyond the distal tip of the catheter shaft.
Figure 1. Deflecting and Flushing the Catheter
Note: Connect the three-way stopcock to the luer fitting prior to flushing the catheter.
Positioning the Distal Tip
1. After gaining vascular access, load the dilator into the catheter using the hemostasis seal and advance the catheter and dilator
over the guidewire to track the position of the guidewire, catheter, and dilator.
CAUTION: Deflecting the catheter while the dilator is inserted may cause catheter damage.
CAUTION: The dilator is designed to be loaded into the Agilis HisPro and advanced over the guidewire.
2. After reaching the right atrium, retract the dilator and guidewire from the catheter.
CAUTION: Excessive manipulation of the catheter while retracting the dilator may lead to catheter damage.
3. Aspirate for the presence of air and flush the catheter through the stopcock. Close the stopcock.