Indications, safety, and warnings for DuoMode™ Cable

INDICATIONS FOR USE

The DuoMode Cable is intended to serve as an extension cable that is used with the Baylis Medical radiofrequency puncture devices, the Baylis Medical Company Radiofrequency Puncture Generator and diagnostic equipment.

CONTRAINDICATIONS

The DuoMode Cable is not recommended for use with any other RF generator.

WARNINGS

• The DuoMode Cable is a reusable device. Failure to properly clean the device can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
• The DuoMode Cable must only be used with Baylis RF Puncture Generators and RF puncture devices. Attempts to use it with other RF Generators and devices can result in electrocution of the patient and/or operator.
• Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency puncture procedures due to the continuous usage of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure.

PRECAUTIONS

• Do not attempt to use the DuoMode Cable or ancillary equipment before thoroughly reading the accompanying Instructions for Use. 
• Puncture procedures should be performed only by physicians thoroughly trained in the techniques of RF powered puncture and use of diagnostic medical equipment in a fully equipped catheterization laboratory. 
• Visually inspect the DuoMode Cable to ensure there is no degradation, such as cracking or damage to the insulating material.  Do not use the cable if there is any damage. 
• The DuoMode Cable is intended for use with RF puncture devices only.
• Never disconnect the DuoMode Cable from the RF Puncture Generator while the Generator is delivering RF power.
• Never disconnect the DuoMode Cable from the Generator by pulling on the cable.  Failure to disconnect the cable properly may result in damage to the cable. 
• Do not twist the DuoMode Cable while inserting or removing it from the Isolated Patient Connector on the Generator.  Twisting the cable may result in damage to the pin connectors. 
• Do not bend the cable.  Excessive bending or kinking of the cable may damage the integrity of the cable and may cause patient injury.  Care must be taken when handling the cable.
• Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the Generator may have on the performance of other equipment.  Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the Generator. 
• Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during RF power applications. 
• During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.
• In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application.
• Baylis Medical Company relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of the Baylis Medical Radiofrequency Puncture System.

ADVERSE EVENTS

The RFP-100A Generator Instructions for Use should be consulted for any adverse events.

97186461 (Rev. A)