AtriCure 80-02 TenSURE Suture Tightener Instruction Manual
- June 10, 2024
- AtriCure
Table of Contents
AtriCure 80-02 TenSURE Suture Tightener Instruction Manual
FIGURE 1
FIGURE 2
FIGURE 3
Carefully Read All Instructions Prior to Use.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician
PACKAGING & STORAGE:
The TenSURE Suture Tightener is sterile (using ethylene oxide gas) in unopened packaging that is designed to maintain sterility unless the primary product pouch has been opened or damaged.
Handle with care. Do not store in excessive heat; a cool dry place is recommended. After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
INTENDED PURPOSE/INDICATIONS:
The TenSURE Suture Tightener is a sterile, single-use device that provides tensile feedback during suture deployment and tightening of the LARIAT Suture Delivery Device. it is designed to specifically accommodate the Suture Release Tab of the LARIAT device
DESCRIPTION:
The TenSURE Suture Tightener is a single-use, sterile device. The device is comprised of a plastic handle and a pre-tensioned spring shaft that allows for tensile feedback. It may be used after the LARIAT Suture Delivery Device has placed a pre-tied suture loop.
COMPLICATIONS:
When used as directed, no adverse effects are expected with use of this device.
Warnings
Never retract the TenSURE Suture Tightener if the red Suture Release Tab is not securely loaded into the device.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
DO NOT tighten beyond the red mark (A) on the TenSURE device (shown in Figure 3) as this may cause damage to the suture or the tissue.
Ensure all instrumentation is free of the closure site prior to pulling with the TenSURE Suture Tightener to prevent other instrumentation from becoming captured during tightening
**** PRECAUTIONS:
Care should be taken to avoid damage when handling the device. Do not use if the device is visibly damaged or deformed.
INSTRUCTIONS FOR USE
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Carefully inspect the TenSURE Suture Tightener and the packaging prior to use. Do not use a device that is damaged in any way or if its packaging is damaged.
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Insert the red Suture Release Tab (FIGURE 2, ITEM B) connected to the end of the pulled suture on the LARIAT device into the TenSURE Suture Tightener. Be sure to align the Suture Release Tab within the grooves in the suture Tightener.
Warning: The Suture Release Tab must be properly aligned within the grooves of the TenSURE device to avoid tissue damage, and bleeding. -
Hold the LARIAT RS LAA Exclusion Device Handle in place and ground hand to the patient, additionally grasping the TenSURE device with two fingers on the Flange (FIGURE 2, ITEM A), pull the TenSURE device away from the LARIAT RS LAA Exclusion Device handle (FIGURE 2, ITEM C) until desired suture closure is achieved indicated by the pin (FIGURE 3, ITEMB) alignment with the handle marks.
Caution: Do not tighten beyond the red mark on the Suture Tightener (FIGURE 3, ITEM A) as this may cause damage to the suture.
Caution: Pull the Suture Tightener straight back from the handle of the LARIAT Suture Delivery Device to avoid damage to the suture. -
Dispose of the TenSURE Suture Tightener device as appropriate in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
All rights reserved. Patent(s) Pending.
Manufacturer
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
+1 513-755-4100 (phone)
**European Representative:
AtriCure Europe B.V.
De entree 260
1101 EE Amsterdam
NL
+31 20 7005560
[email protected]