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RHYTHMIA INTELLANAV Connection Box

Indications, Safety, and Warnings


INTENDED USE

The INTELLANAV Connection Box is an accessory to the RHYTHMIA Mapping System. It is intended for use during mapping and ablation procedures. The connection box routes intracardiac signals, sensed by the INTELLANAV catheter, to the RHYTHMIA Mapping System’s Signal Station. It is designed to be used with the RF generator designated by its device label.

INDICATIONS FOR USE

The RHYTHMIA Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.

CONTRAINDICATIONS

None known.

WARNINGS

The INTELLANAV Connection Box is intended for use with the RHYTHMIA Mapping System and other medical devices in an electrophysiology laboratory. Prior to each use, carefully read all device Instructions for Use. Always observe all contraindications, warnings, and cautions. Failure to do so may result in user harm or patient illness, injury, or death. Use the INTELLANAV Connection Box with only compatible Maestro and Stockert (EP-Shuttle) RF generators. Do not use other RF generators for which compatibility is not demonstrated. Do not apply RF energy larger than 150W to ablation catheters that are connected to a Maestro RF generator and the RHYTHMIA Mapping System. Do not apply RF energy larger than 70W to ablation catheters that are connected to a Stockert (EPShuttle) RF generator and the RHYTHMIA Mapping System.

CAUTIONS

Do not use excessive force when connecting or disconnecting cable connectors. Excessive force can damage the connectors, which may cause device malfunction. To avoid equipment damage and malfunction, do not insert anything (e.g., cotton swabs or pins) into cable connectors or equipment sockets or openings. Follow established guidelines for cleaning the device. Never immerse components in water, cleaning solutions, or liquid. Ensure that connectors remain dry. Failure to follow cleaning guidelines may cause equipment damage, and void any warranties or service agreements. Never clean the device during system operation. Cleaning equipment during use increases the risk of electrical shock and device malfunction. To avoid equipment damage and malfunction, do not attempt to sterilize the INTELLANAV Connection Box. Always clean and disinfect the device according to established guidelines for cleaning the device. Do not use glutaraldehyde or hydrogen peroxide to clean the device. Do not use acetone. Do not use the device if it is soiled or contaminated with infectious, or potentially infectious, materials. Using soiled or contaminated items increases the risk of patients acquiring serious infections or contaminating other patients or users. Soiled or contaminated cables and equipment must be removed from use, and replaced or cleaned according to established facility protocol components.

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