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Indications, safety, and warnings for Helix Locking Tool 

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Helix Locking Tool is intended to facilitate lead fixation by providing control over the extension and retraction of the lead helix of an IS-1 pacing or defibrillator lead. It is also intended to facilitate insertion of a stylet into the lead through the terminal pin.

CONTRAINDICATIONS

The IFU for this document does not contain contraindications, so no additional information is required for this section in the BSD

WARNINGS

  • When using the tool, do not rotate the lead terminal pin more than the maximum number of turns recommended by the lead manufacturer. Continuing to rotate the terminal pin can cause lead damage, lead dislodgement, tissue trauma, and/or voltage thresholds to rise.
  • Remove the tool from the lead terminal pin before placing the lead terminal pin in the patient and securing the lead and/or connecting the lead to a pacemaker/defibrillator.
  • For single use/single procedure only. Do not reuse, reprocess, or resterilize. Such may cause failure of the tool and/or infection or cross-contamination.
  • Do not expose the tool to the MR environment.  Testing has not been performed to establish safe use in this environment.

PRECAUTIONS

  • Read these instructions and consult the literature provided by the lead manufacturer prior to use.
  • Inspect the tool and its packaging prior to use.  Do not use if the package is open or there is any evidence of package or tool damage.
  • Store in a cool, dark, dry location.

POTENTIAL ADVERSE EVENTS

The IFU for this document does not contain potential adverse events, so no additional information is required for this section in the BSD

97286357 (Rev A.1)