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Federal (USA) law restricts this device to sale by or on the order of a physician.
PRODUCT DESCRIPTION
The ESTECH Soft Tissue Atraumatic Retractor (STAR) is a single-use sterile device. The STAR consists of a
set of silicone straps with a customizable retraction system that allows the surgeon to configure the straps in a
manner that provides the best access to the surgical site.
accommodate different size incisions.
INDICATION FOR USE
The ESTECH STAR is intended for use in cardiothoracic procedures to retract soft tissues adjacent to a
sternotomy, thoracotomy, or other surgical port.
WARNINGS AND PRECAUTIONS
•
Federal Law (USA) restricts this device to sale by or on the order of a physician.
•
Do not use this device if package is damaged or opened.
•
Do not use this device if it shows signs of damage, e.g., crimps, kinks, or crushed areas.
•
This device is for single use only. DO NOT REUSE. DO NOT RESTERILIZE.
•
Proper surgical procedures and techniques are necessarily the responsibility of the medical profession.
These instructions are furnished for informational purposes only. Each surgeon must evaluate the
appropriate use of this device, case by case, based on medical training, experience, and the type of
surgical procedure employed.
•
Dispose of used products in accordance with established hospital protocol for hazardous waste.
Verify all user connections of this device are secure prior to use. USAGE INSTRUCTIONS
NOTE: Use of the STAR requires that an incise drape (3M Ioban™ 2 or equivalent) be used to cover the
thoracotomy site. The adhesive pads on the STAR may not adhere properly to bare skin.
1. Using aseptic technique, remove the STAR from sterile packaging and place in the sterile field.
2. Fold the STAR in half and insert into thoracotomy incision with silicone straps perpendicular to the long axis
of the incision. Holding the ring folded with one hand, push the exposed portion of the ring with opposite
hand until the ring completely inside the chest
NOTE:
STAR ring diameter should be greater than incision length to minimize potential for ring to
withdraw from incision under tension.
3. Once inserted into the incision, grasp the straps and push the device in fully to allow the ring to deploy,
resuming its circular shape. Gently pull the straps outward and align to create a uniform profile, covering all
soft tissue.
4. Peel the backing off of one of the adhesive pads and fasten to the chest. Peel the backing off of the strap
opposite to the first strap installed, and fasten to the chest wall. Continue fastening the straps the chest in
this manner. Opposite straps will have the same logo printed on them (either ESTECH or STAR logo).
NOTE:
Ensure that the draping is dry in the area that the adhesive pad will be fastened to. Avoid
contacting adhesive pad with wet materials, as this will reduce adhesion.
WARNING: Avoid excessive tensioning of the straps and/or sequential fastening of adjacent straps. This
may cause ring migration or dislodging of the device from the incision.
5. When all straps have been fastened, verify that all adhesive backings which were removed have been
collected and discarded appropriately.
6. ESTECH recommends the use of the SI retractor in conjunction with the STAR to retract the ribs and
enlarge the surgical window.
WARNING: If the SI retractor is used, do not attempt to spread the incision larger than the diameter of the
metal ring. Doing so may cause damage to the SI retractor blades.
NOTE: If the SI retractor is used, select blades that are appropriate for the chest wall thickness. If blades
that are much longer than the chest wall thickness are used, the SI retractor may migrate when expanded.
430-13472-02 Rev C
READ ALL INSTRUCTIONS BEFORE USE!
Single Use Device. Do not resterilize.
The STAR is available in different sizes to
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