Abbott Agilis HisPro DS3H010-38, Instructions For Use Manual

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Warnings
 This device is intended for one time use only. Do not reprocess or reuse. Thorough cleaning of biological and foreign material is
not possible. Reuse can cause device failure, patient injury, and/or the communication of infectious disease(s) from one patient
to another.
 This device should be used by or under the supervision of physicians thoroughly trained in the techniques of pacing lead
implantation.
 Thrombus Generation: Thrombogenicity testing was performed using a four-hour heparinized ovine model. If the patient cannot
be anticoagulated during the procedure, thrombus formation may occur during use of the product.
 Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury
as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity
and duration of the fluoroscopic imaging. Careful consideration must be given for the use of this catheter in pregnant women.
 Careful catheter manipulation must be performed in order to avoid device component damage, thromboembolism,
cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. If resistance is encountered,
DO NOT FORCE THE CATHETER . Withdraw the catheter, correct the difficulty, and reinsert.
 Risks associated with electrical stimulation may include, but are not limited to, the induction of arrhythmias, such as atrial
fibrillation (AF), ventricular tachycardia (VT) requiring cardioversion, and ventricular fibrillation (VF).
 FROM THE STOPCOCK ONLY, ASPIRATE ALL AIR PRIOR TO FLUID INFUSION.
Precautions

For specific details in the use of electrophysiology devices and the techniques employed in an electrophysiology study, refer to
the medical literature and rely on training and practical experience.

This device should only be used with equipment that complies with international electrical safety standards.

Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired
curve. Do not use if the catheter does not hold its curve and/or if the irrigation port or hemostasis valve is blocked.

Do not alter this device.

Bending, stretching, and/or kinking of the catheter may result in damage. Handle with care.

Do not immerse the handle or cable connector in fluids; electrical performance could be affected.

Do not expose to organic solvents.

Precautions to prevent clotting should be taken whenever entering the vascular system. The patient's clotting system should be
evaluated prior to catheterization. Use anticoagulant as training and experience may dictate.

Flush the lumen of the catheter and dilator with saline prior to use.

Aspirate slowly only from the stopcock.

Inject or saline flush only from the stopcock.

Not intended for use with high-pressure injection equipment.

This catheter should only be maneuvered under fluoroscopic guidance. The long-term risk of protracted fluoroscopy (i.e.,
fluoroscopic radiation) has not been established. Careful consideration must be given for the use of the device.

Care must be taken to avoid damage to the wall of the vessels through which these catheters pass.

THE CATHETER IS OPTIMIZED FOR THE DELIVERY OF 6FR PACING LEADS (58CM+). DO NOT USE LEADS
SHORTER THAN 58CM.

To prevent entanglement with existing or abandoned leads, use care when using the catheter in proximity of the other leads.

Exercise caution when using movable core guidewires. Avoid twisting or excessive force on guidewires, which may cause core
wire to penetrate the coil spring of the guidewire and damage the catheter or vessel.

Do not attempt to advance or withdraw the guidewire if unusual resistance is felt. Use fluoroscopy to determine cause.

Do not inadvertently allow the guidewire to advance completely into the patient or device.

The sealing force of the hemostasis valve may alter or impair the function of some guidewires.

Damage to the hemostasis valve may occur if the guidewire or other inserted device is withdrawn rapidly.

Use care to isolate any unused connector pins of the electrogram cable. This will reduce the chances of developing accidental
current pathways to the heart.

Make sure deflection knob is in the neutral position when advancing, retracting, or while slitting the catheter.

THE CATHETER IS ONLY INTENDED TO BE SLIT USING THE SLITTER TOOL INCLUDED IN THIS PACKAGE. NO
OTHER COMMERCIALLY AVAILABLE SLITTER SHOULD BE USED
.
Sterilization

The package contents have been sterilized with ethylene oxide before shipment. The package contents are for single use only
and are not intended to be resterilized.

If the sterile package has been compromised, do not use. Contact Abbott Medical.