Stablemapr SM Series

Indications, Safety, and Warnings

Indications for Use

The Medtronic StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications

There are no known contraindications for this catheter.

Warnings

This device is for single use only. Do not resterilize and reuse the catheter. This may result in loss of proper electrical and mechanical function.

• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end isolated”, or have an isolated patient cable (IEC 601-1 Type CF equipment or equivalent). Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection and death.
• Use only connecting cables supplied by Medtronic or patient injury, operator injury, or equipment damage may occur.
• Do not allow moisture into connectors of the StableMapr catheter or connecting cables. If the connectors get wet, the system may not function correctly.
• The safety and effectiveness of this device as an ablation catheter have not been established. Therefore, such use is considered investigational.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.