Johnson & Johnson Biosense Webster LASSO 2515 Mode D'emploi page 6

Cathéter de cartographie circulaire variable

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Table des Matières

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The L

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Note: Do not use the L

PRECAUTIONS

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The catheter should be stored in its original packaging and in a cool, dry place until it is used.

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Read all accessory operating instructions prior to connection of the L

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Do not attempt to operate the L

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Cardiac catheterization procedures should be performed by appropriately trained personnel in a fully equipped electrophysiology laboratory.

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Careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement and placement should be done under fluoroscopic

guidance through a guiding sheath. Do not use excessive force to advance or withdraw the catheter through the guiding sheath, when resistance is encountered. In addition,

extra care should be taken while inserting, aspirating and manipulating the guiding sheath.

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The sterile packaging and catheter should be inspected prior to use.

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The L

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Do not resterilize and reuse.

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This device is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity

of the device and/or lead to device failure that in turn may result in patient injury, illness or death. Also, reprocessing or resterilization of single use devices may create a risk of

contamination and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination

of the device may lead to injury, illness, or death of the patient.

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Always pull the thumbknob of the catheter back before insertion or withdrawal to assure that the catheter tip assumes its original shape.

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To avoid char formation on the L

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"USE BY" DATE

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This catheter is sterilized with ethylene oxide gas.

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Do not use if the package is open or damaged.

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Use the device prior to the "Use By" date on the package label.

DISPOSAL

Recycle components, or dispose of the product and its residual elements or waste items in accordance with local laws and regulations.

SUGGESTED INSTRUCTIONS FOR USE

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Remove the catheter from its package and place it in a sterile work area.

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Follow standard practice for vessel puncture, guidewire insertion and guiding sheath use and aspiration per its Instructions for Use.

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Connect the interface connectors to the appropriate recording equipment.

NOTE: Read pacing and recording equipment operator manual for proper set up and operation.

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Confirm that the thumbknob is pulled back completely before insertion and that the loop-contraction mechanism is not activated, ensuring minimal tension to the Nitinol loop.

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Adjust the loop diameter with the handle grip. By rotating the handle grip to the right, the loop contracts; by rotating the grip to the left, the loop expands (see Figure 1).

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Adjust the radius of curvature as necessary by manipulating the thumbknob. Pushing the thumbknob forward causes the catheter tip to bend (curve); when the knob is pulled

back, the tip straightens.

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Prior to removal of the catheter, confirm that the thumbknob has been pulled back completely and that the loop is in a fully relaxed position (handle grip rotated fully to the left).

Remove the catheter through the guiding sheath and dispose of it in an appropriate manner. Remove the guiding sheath, vessel dilator and guidewire as a unit per its

Instructions for Use. Do not resterilize and reuse.

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If there are any questions regarding the use or performance of this product, please consult with the local distributor or the manufacturer.

ADVERSE REACTIONS

A number of serious adverse reactions have been documented for cardiac catheterization procedures including pulmonary embolism, myocardial infarction, stroke, cardiac

tamponade, and death.

The following complications associated with cardiac catheterization have also been reported in the literature: vascular bleeding, local hematomas, thrombosis, AV fistula,

pseudoaneurysm, thromboembolism, vasovagal reactions, cardiac perforation, air embolism, arrhythmias, valvular damage, pneumothorax and hemothorax.

WARNING: This is a controlled proprietary and confidential document.

2515 Variable Circular Mapping Catheter is recommended for use with the Biosense Webster P

2515 Variable Circular Mapping Catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25mm in diameter.

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2515 Variable Circular Mapping Catheter prior to completely reading and understanding these Instructions for Use.

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2515 Variable Circular Mapping Catheter is intended for single patient use only.

2515 Variable Circular Mapping Catheter rings, do not apply RF energy when the ablation catheter is in contact with one or more of the

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2515 Variable Circular Mapping Catheter electrodes.

Braided Guiding Sheath.