The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a Medtronic cardiovascular stimulating instrument to a Medtronic cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.
For more information about the temporary cardiac pacing system, including indications for use, refer to the technical manuals for the cardiovascular stimulating instruments.
The device is used as part of a temporary cardiac pacing system based on the principle of transmitting electrical signals between the cardiovascular stimulating instrument and the cardiac pacing leads. The device allows real-time continuous and accurate pacing and sensing electrical connection during lead implantation. After the implantation procedure is finished, the device is disconnected and discarded.
The rotatable connector is intended to be used with:
There are no known contraindications for the Model 5944RL rotatable connector.
Cable handling — When handling the cables, do not allow the exposed metal to contact electrically conductive surfaces or wet surfaces other than the cardiac pacing leads. Do not touch the exposed metal conductive surfaces.
Connection order — Connect the rotatable connector cable system to the cardiovascular stimulating instrument before connecting it to the pacing leads and/or unipolar reference. When disconnecting the cable, disconnect from the pacing leads and/or unipolar reference before disconnecting from the cardiovascular stimulating instrument.
Do not modify — Do not modify this equipment. Modifications may reduce system effectiveness and impact patient health and safety.
Humidity — Do not expose the cable to humidity greater than 95%.
If the package information is damaged – If any information on the outer package is defaced or damaged so that you cannot read it, do not use, and notify Medtronic.
Inspecting the sterile package – Inspect the sterile package and cables with care before opening it.
Product compatibility — This accessory has not been tested for use with non-Medtronic products.
Review the system documentation — Because the cable system is part of a cardiac pacing system, review all applicable documentation for warnings, complications, precautions, and instructions.
Single-use — This device is intended for single use only. Do not reuse, reprocess, or resterilize this device for the purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device which could impact performance or create a risk of contamination of the device that could result in patient injury, illness, or death.
Storage temperature — Do not expose the cables to storage temperatures above 30°C (86°F) or below 15°C (59°F).
Transit temperature — Do not expose the cable package to transit temperatures above 70°C (158°F) or below -40°C (-40°F).
Technical manual information — If you find information in this manual that is incorrect or illegible, contact your Medtronic representative.
Product Disposal — The device described in this document must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products.
These are the potential adverse events that can occur or can require intervention when using this device:
Note: If a serious incident related to the device occurs, immediately report, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.
MAJ_89507
Find more information, including other available configurations, for Medtronic™ rotatable connector 5944RL.
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