Johnson & Johnson Biosense Webster ThermoCool SF Mode D'emploi page 5

Cathéter de diagnostic et d'ablation à extrémité orientable

Table des Matières

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21. Electrophysiology catheters and systems are intended for use only in X-ray shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines.

22. Do not attempt to operate the Biosense Webster T

instructions for use.

23. Cardiac ablation procedures should be performed by appropriately trained personnel in a fully equipped electrophysiology laboratory. Appropriate clinical instruction in the use of the T

Catheters should also be completed.

24. The long-term risks of protracted fluoroscopy and creation of RF induced lesions have not been established. Careful consideration must therefore be given for the use of the device in prepubescent children.

Furthermore, the risk/benefit in asymptomatic patients has not been studied.

25. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation, and many physicians prescribe aspirin, less often warfarin, for about 3 months afterward. No

consensus yet exists about the need for short-term anticoagulation after ablation.

26. When using the Biosense Webster T

manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be done under fluoroscopic guidance. Do not use excessive force to advance or

withdraw the catheter when resistance is encountered. The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.

27. Always pull the thumbknob back to straighten the catheter tip before insertion or withdrawal of the catheter.

28. Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter. Do not use this catheter without irrigation flow.

29. When RF current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum, if present. When cleaning the tip

electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode. Make sure the irrigation holes are not plugged

prior to re-insertion.

30. Apparent low power output, high impedance reading, or failure of the equipment to function correctly at normal settings may indicate faulty application of the indifferent electrode(s) or failure of an electrical

lead. Do not increase power before checking for obvious defects or misapplication of the indifferent electrode or other electrical leads.

31. The Biosense Webster T

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other appropriate interface cables and connectors. Use of a compatible irrigation pump is recommended to assure proper irrigation flow rate.

32. The Biosense Webster T

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near structures such as the sino-atrial and atrioventricular nodes.

33. The sterile packaging and catheter should be inspected prior to use. Do not use if the packaging or catheter appears damaged.

34. The catheter is sterilized with ethylene oxide gas and should be used by the "Use By" date on the device package. Do not use the catheter if past the "Use By" date.

35. The Biosense Webster T

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36. Do not resterilize and reuse.

37. Do not use near MRI equipment since movement or heating of the catheter may occur and the image on the display may become distorted.

38. Use both fluoroscopy and electrogram data to monitor catheter advancement and reduce risk of tissue injury.

39. The Biosense Webster T

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can result from improper handling of the catheter and indifferent electrode, particularly when operating the catheter. During energy delivery, the patient should not be allowed to come in contact with

grounded metal surfaces.

40. The risk of igniting flammable gases or other materials is inherent in electrosurgery. Precautions must be taken to restrict flammable materials from the electrosurgical suite.

41. Electromagnetic interference (EMI) produced by the Biosense Webster T

operation, may adversely affect the performance of other equipment.

42. Electrodes and probes for monitoring and stimulating devices can provide paths for high frequency current. The risk of burns can be reduced but not eliminated by placing the electrodes and probes as far

away as possible from the ablation site and the indifferent electrode. Protective impedances may reduce the risk of burns, and permit continuous monitoring of the electrocardiogram during energy delivery.

43. The temperature sensor measures electrode tip temperature, not tissue temperature. The temperature displayed on the RF generator is for the cooled electrode only and does not represent tissue

temperature. If the RF generator does not display temperature, verify that the appropriate cable is plugged into the RF generator. If temperature still is not displayed, there may be a malfunction in the

temperature sensing system that must be corrected prior to applying RF power.

44. The temperature measurement accuracy of the Biosense Webster T

largely determined by the temperature accuracy specification of the RF generator used. Please consult the user manual for the RF generator to be used for the temperature accuracy specification.

45. Before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.

46. Regularly inspect and test reusable cables and accessories.

RF Ablation

For RF ablation, the catheter must be connected to the appropriate input connector(s) on the RF generator. For proper interface use only Biosense Webster or compatible interface cables. To complete the

electrical circuit, an indifferent electrode must be connected to the indifferent electrode input on the RF generator. Verify that circuit impedance prior to RF ablation is within expected parameters. Verify that the

RF generator displays a temperature not above 37 °C after the catheter is inserted into the patient and before applying RF power.

RF Generator Operation

Refer to the applicable RF generator manual for proper operation of the RF generator.

RF ablation application parameters will vary depending on the ablation site, the specific conditions present in each procedure and the RF generator control circuitry. Based on data obtained from prior animal and

clinical studies, recommended RF application parameters are provided below in the "Directions for Use" and in Table 2. Always monitor temperature and impedance rise when using the

Biosense Webster T

SF Diagnostic/Ablation Deflectable Tip Catheter.

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How Supplied

The Biosense Webster T



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Refer to Table 1 in the Device Description section of this Instructions for Use for available curve types for the various catheter configurations.



Additional catheter accessory devices are provided separately.



Storage

The Biosense Webster T

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Sterilization/"Use By" Date

This catheter has been sterilized with ethylene oxide gas. Product and package testing have been conducted to support the "Use By" date printed on the product labels. DO NOT USE after the "Use By" date.

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.

Disposal

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

Directions for Use

Please refer to the User Manuals for the irrigation pump, RF generator and the irrigation tubing for instructions on connecting and operating these systems in conjunction with the

Biosense Webster T

SF Diagnostic/Ablation Deflectable Tip Catheter. Use appropriate Biosense Webster accessory cables to connect the Biosense Webster T

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Deflectable Tip Catheter to the appropriate accessory equipment.

Using aseptic technique, remove the catheter from the package and place in a sterile work area. Inspect the catheter carefully for electrode integrity and overall condition.

Create a vascular access in a large central vessel using aseptic techniques.

To verify compatibility between the sheath and catheter, advance the catheter through sheath prior to insertion.

Connect the catheter to the recording equipment and/or the RF generator using the appropriate Biosense Webster cable. To complete the electrical circuit, connect an indifferent electrode to the indifferent

electrode input on the generator.

Connect the irrigation tubing to a room temperature, heparinized (1 u heparin/ml) normal saline bag using standard safe hospital practices. Open the stopcock on the end of the irrigation tubing and fill the

irrigation tubing as slowly as possible. Remove any trapped air and then close the stopcock.

Load the irrigation tubing into the irrigation pump. Open the stopcock and flush the irrigation tubing per the irrigation pump instructions until the air is expelled through the open end of the tubing.

Connect the stopcock on the end of the irrigation tubing to the Luer fitting of the Biosense Webster T

Flush the catheter and tubing per standard technique to ensure purging of trapped air bubbles and to verify that the irrigation holes are patent.

Start continuous irrigation at a flow rate of 2 ml/min.

10. Insert the Biosense Webster T

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Use both fluoroscopy and electrograms to aid in proper positioning.

11. Deflection of the Catheters:

M-5276-688A

WARNING: This is a controlled proprietary and confidential document.

SF Diagnostic/Ablation Deflectable Tip Catheter or the RF generator prior to completely reading and understanding the applicable

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SF Diagnostic/Ablation Deflectable Tip Catheter with conventional systems (using fluoroscopy to determine catheter tip location), careful catheter

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SF Diagnostic/Ablation Deflectable Tip Catheter is intended for use only with a compatible RF generator, a compatible irrigation pump, Biosense Webster cables, and

SF Diagnostic/Ablation Deflectable Tip Catheter has been shown to create larger lesions than standard RF ablation catheters. Care should be taken when ablating

SF Diagnostic/Ablation Deflectable Tip Catheter is intended for single patient use only.

SF Diagnostic/Ablation Deflectable Tip Catheter used in conjunction with a RF generator is capable of delivering significant electrical power. Patient or operator injury

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SF Diagnostic/Ablation Deflectable Tip Catheter is supplied Sterile (EtO) unless the package is damaged or opened.

SF Diagnostic/Ablation Deflectable Tip catheter must be stored in a cool, dry place. Storage temperature should be between 5 and 25 °C (41 and 77 °F).

SF Diagnostic/Ablation Catheter via the entrance site, using a guiding sheath with a minimum size of 8 F. Advance the catheter to the area under investigation.

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SF Diagnostic/Ablation Deflectable Tip Catheter, when used in conjunction with an RF generator during normal

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SF Diagnostic/Ablation Deflectable Tip Catheter, as with any temperature measurement electrophysiology catheter, is

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SF Diagnostic/Ablation Deflectable Tip Catheter.

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English

Irrigated

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