System Description; Potential Complications - Torax Linx Gebrauchsanleitung

INTENDED USE/INDICATIONS FOR USE
The LINX™ Reflux Management System Esophagus Sizing Tool is used to determine the appropriate size LINX™
Reflux Management System device by associating the circumference of the esophagus with the appropriate
LINX™ device.

SYSTEM DESCRIPTION

The LINX™ Reflux Management System sizing tool is a laparoscopic instrument with a soft, circular curved
tip that is actuated by coaxial tubes all via a handset. The handle set contains a numerical indicator that
corresponds with the size range of the LINX™ device.

POTENTIAL COMPLICATIONS

The following is a list of potential complications that may occur with the use of the LINX™ sizing tool: These may
include, but may not be limited to Bleeding, Death, Injury to the esophagus, spleen, stomach or other organs,
Pain, Peritonitis, Pneumothorax.
PRECAUTIONS
1. Use of the device should only be performed by those physicians who have experience in laparoscopic anti-
reflux procedures.
2. The sterile package and device should be inspected prior to use. If sterility or performance of the device is
suspect or compromised, it should not be used.
3. The device is intended for single use only. DO NOT resterilize the device. Functionality and sterility of the
device can not be assured if re-used.
4. The device is magnetic and will be attracted to ferrous objects in the surgical field and other surgical
instruments that are ferromagnetic.
WARNINGS
1. The device should not be exposed to temperatures above 100 degrees C as this could adversely affect the
distal connecting magnets and the function of the device.
DIRECTIONS FOR USE
1. Surgical Access:
1.1 Gain surgical access to the esophagus through a laparoscopic port at the region of the
gastroesophageal junction.
1.2 Dissect the soft tissues away from the outside of the esophagus at the location of the
gastroesophageal junction. Tissue should be removed to expose the outer muscle of the esophagus.
Create a tunnel under the posterior vagus nerve through the peri-neural tissue. The anterior vagus
nerve will be included within the implant. Care should be taken to avoid injuring the vagus nerve
bundles.
2. Sizing of the Esophagus:
2.1 Bring sizing tool into surgical field through a laparoscopic port of minimum internal diameter of 5mm.
2.2 Place the sizing tool around the esophagus in the dissected space around the exposed outer muscle
and through the tunnel created under the posterior vagus nerve bundle.
2.3 Retract the sizing tool handle set until distal loop has positioned itself around the esophagus. If
retracted too far the distal magnets will separate. Observe the scale in the handle set to determine
bead size of the LINX™ device.
2.4 Choose the bead size that corresponds to where the indicator mark falls.
PACKAGING/STORAGE
The LINX™ Sizing Tool is provided sterile and designed to remain sterile unless the primary product pouch has
been opened or damaged. Store in a cool, dry place. If opened and not used, discard device or return device to
Torax Medical Inc. Do Not Resterilize.
ENGLISH
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