Abbott A001HELX Manual De Instrucciones página 3

EN: English
Helix Locking Tool
User's Manual
Intended Use
The Helix Locking Tool (Model A001HELX) is designed to aid with the Tendril™ STS (Model 2088TC) and is a
non‑implantable accessory tool designed to aid with lead fixation by providing control over the extension and
retraction of the helix. This can be an alternative to the clip‑on tool. The Helix Locking Tool is placed on the
lead by inserting the tool on the connector pin. The longitudinal slot feature on the Helix Locking Tool allows
for placement on the lead with a stylet already in place.
Refer to the appropriate lead user's manual for a complete list of lead‑specific indications, contraindications,
warnings, precautions, potential adverse effects and instructions for use.
Figure 1. Helix Locking Tool
Clinical Benefits
The Helix Locking Tool is primarily used to facilitate the implantation of implantable transvenous pacing leads.
Thus, this accessory is contributing to the same clinical benefits associated with the pacing leads. When this
device performs as intended, it provides the associated clinical benefits to the target patients. When the leads
and the device system perform as intended, they provide the appropriate pacing therapy to manage their
heart conditions.
Securing the Tip
Securing the Tip with the Helix Locking Tool
As an alternative to the clip-on tool, the Helix Locking Tool may be used to extend or retract the helix.
1. 1. Check the Use‑By date on the packaging. Do not use tool if the Use-By date has passed.
2. 2. Aseptically remove tool from packaging.
Do not use tool if:
– – – Dropped from packaging
– – – Sterility is breached
3. 3. Slide Helix Locking Tool onto the connector end of lead. The tool should be fully inserted as shown in
illustration.
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