English - Instructions For Use - St.Jude Medical FAST-CATH Mode D'emploi

State: Released Date: 2010.03.25 15:09 GMT
English
See Product Catalog for Reorder Numbers.
THE FRENCH SIZE SPECIFIED REPRESENTS THE INNER DIAMETER OF THE INTRODUCER SHEATH.
DO NOT ATTEMPT TO INSERT A CATHETER HAVING A DISTAL TIP OR BODY SIZE LARGER THAN THE INTRODUCER SIZE
INDICATED.
THE ST. JUDE MEDICAL HEMOSTASIS INTRODUCER IS DESIGNED TO INTERLOCK ONLY WITH ST. JUDE MEDICAL DILATORS
AND/OR OBTURATORS. MISUSE MAY RESULT IN SERIOUS COMPLICATIONS.
SEE INDIVIDUAL STERILE PACKAGE LABEL FOR CONTENTS.
SINGLE-USE DISPOSABLE MEDICAL DEVICE. CONTENTS ARE STERILE IF PACKAGE IS UNOPENED AND
UNDAMAGED. DO NOT RESTERILIZE.
CAUTION:
DO NOT alter this device.
Federal law (U.S.) restricts this device to sale by or on the order of a physician.
Do not attempt to use a guidewire over maximum diameter specified on package label.
This device should only be used by physicians thoroughly trained in the technique of angiography and/or the use of St. Jude
Medical catheter delivery systems.
Individual patient anatomy and physician technique may require procedural variations.
The closing force of the hemostasis valve may alter or impair the function of some catheters.
Damage to guidewire may result if withdrawn through a metal needle cannula. Cannula must be removed first.
Do not attempt to advance or withdraw guidewire if resistance is felt. Use fluoroscopy to determine cause.
Damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
Advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.
STORE IN A COOL, DARK, DRY PLACE.
PRECAUTIONS:
For Single Use Only! Single-use devices are designed and tested for only one patient application. These are disposable
introducers and are not designed for reprocessing and reuse. Reuse of designated "single-use" introducers creates a risk of
patient or user infections (Viral, Bacterial, Prion and Endotoxin exposure, e.g.) due to protein retention in plastic materials (from
prior use) and the difficulty in cleaning the narrow structures at material interfaces and introducer lumen diameter following
direct blood contact. Aqueous based cleaning processes may introduce pyrogens. There is no validated method to remove
prions from these devices. Contamination or reprocessing cleaning agent residues may lead to adverse patient reactions.
Furthermore, cleaning, disinfection and sterilization methods not tested or approved by SJM used on the introducer may
compromise the structural integrity of the introducer plastic materials (PE, Polycarbonate, ABS, PVC, and Silicone Rubber) and
compromise design characteristics leading to device malfunction or failure resulting in patient injury, permanent impairment
or death. Use of non-SJM packaging may compromise device functionality and sterility due to compromised protection from
shipping and handling damage. And the absence of labeling after reprocessing, may lead to misuse of the introducer and
impaired traceability. Reprocessing and reuse may result in patient or user injury, permanent impairment or death.
APPLICATION
The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a vessel where
minimizing blood loss is essential.
SUGGESTED DIRECTIONS FOR USE
INSPECT SHEATH INTRODUCER AND ACCESSORIES FOR DAMAGE, DO NOT USE ANY DAMAGED DEVICES.
BEFORE PROCEEDING, VERIFY THE HEMOSTASIS INTRODUCER IS OF PROPER SIZE TO ALLOW PASSAGE OF DESIRED
CATHETER OR OTHER MEDICAL DEVICE.
FLUSH THE DILATOR(S), INTRODUCER SHEATH AND INFUSION SIDEPORT AND STOPCOCK WITH HEPARINIZED NORMAL
SALINE.
1. Insert dilator into hemostasis valve. Follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator
and hemostasis introducer use. For introducers with shaped distal tips, always advance dilator/sheath assembly over
appropriate sized guidewire to the appropriate anatomical site.
CAUTION: DO NOT ATTEMPT ADVANCEMENT WITHOUT GUIDEWIRE. SEVERE VASCULAR DAMAGE AND/OR
INJURY MAY OCCUR.
CAUTION: INSERTION INTO ARTERY MAY CAUSE EXCESSIVE BLEEDING AND/OR OTHER COMPLICATIONS.
CAUTION: DO NOT ALLOW GUIDEWIRE TO INADVERTENTLY ADVANCE TOTALLY INTO PATIENT.
2. When a sideport introducer is used, follow normal practice of using a continuous drip of anticoagulant fluid under pressure
through the sideport when the hemostasis introducer is in the vessel.
CAUTION: UPON WITHDRAWAL OF DILATOR, CATHETER OR OTHER INSERTED DEVICE, ASPIRATION
THROUGH THE STOPCOCK IS RECOMMENDED TO REMOVE ANY FIBRIN ACCUMULATION.
3. A St. Jude Medical repositioning sleeve may be used with the hemostasis introducer to provide an added measure of
environmental protection to catheters (see St. Jude Medical product catalog).
4. Follow manufacturer's recommendations for the catheter or device being introduced via the hemostasis introducer.
5. When using the St. Jude Medical luer-lock hemostasis introducer, a St. Jude Medical luer-lock obturator may be used to
seal off the hemostasis aperture and aid in maintaining sheath patency and general management of the introduction site.
OVERFLUSHING
The French size shown on each St. Jude Medical introducer represents the tip inside dimension.
To overflush Catheters or St. Jude Medical Luer-Lock Obturators placed into a St. Jude Medical hemostasis introducer, use
introducer that is one (1) French size larger than the French size of the catheter or obturator.
CAUTION: UPON REMOVAL OF HEMOSTASIS INTRODUCER, PROPER PRECAUTIONS SHOULD BE TAKEN TO
PREVENT BLEEDING.
INTRODUCER WITH SHAPED DISTAL TIPS
Reinsert the dilator fully into the introducer sheath to aid in straightening the top portion. Then remove the dilator and introducer
sheath as a unit.
NOTE: The symbols section contains all the symbols that may be used on product labels. Product is labeled as required.
FAST-CATH™
HEMOSTASIS INTRODUCER
Instructions for use
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