NATHANSON LIVER RETRACTORS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Nathanson Liver Retractors are constructed of stainless steel and are
anodized to eliminate light reflection. The product is available in two sizes.
INTENDED USE
The Nathanson Liver Retractors are intended to support and retract the
liver during laparoscopic upper GI surgery. The product is intended for use
by physicians trained and experienced in laparoscopic surgical techniques.
Standard techniques should be employed.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
None known
PRODUCT RECOMMENDATIONS
Use with a Retractor Arm
The Nathanson Liver Retractors can be held in place by any of the following
commercially available mechanical arms:
• The Murdoch Arm—Dedicated Locking Handle
• The Bookwalter® Retractor—Clamp Code 50-4582, which attaches to the
horizontal flex bar (NOTE: Bookwalter is a registered trademark of Codman
and Shurtleff, Inc.)
• The Iron Intern®—The Universal Gemma Connection Clamp Code NSN6515-
01, 100-5561 G9 (NOTE: Iron Intern is a registered trademark of Automated
Medical Products Corp.)
NOTE: The retractor arm should be placed on the opposite side of the table
from the surgeon's working side.
Sterilization Parameters
The Nathanson Liver Retractors can be sterilized by steam autoclave at 121
degrees C for 15 minutes. The retractors should be thoroughly cleaned and
decontaminated prior to sterilization.
INSTRUCTIONS FOR USE
1. Insufflate the peritoneal cavity in the normal manner.
2. Upon obtaining set maximum pressure, insert a 5 mm trocar at the
appropriate location.
NOTE: The insertion point for the liver retractor depends upon the
procedure being performed, size of the patient and personal preference
of the surgeon. For example, when performing a Nissen fundoplication, an
optimal site may be at the point inferior to the xiphoid process.
3. Remove the trocar and enlarge the tract, if necessary, with a pair of artery
forceps.
4. Holding the liver retractor by the handle and maintaining the curved
radius in a vertical position, insert the retractor with a twisting motion.
5. Under direct laparoscopic vision, maneuver the curved edge of the liver
retractor in a superior direction under the left lobe of the liver. Do not
connect the liver retractor to the retractor arm at this point.
6. Continue placement of the ports. When this is complete, attach the liver
retractor to the retractor arm and elevate the liver to the desired position.
Periodic adjustment of the retractor tension may be necessary throughout
the procedure.
HOW SUPPLIED
Supplied non-sterile. Reusable. Do not use the product if there is doubt as to
whether the product is sterile. Store in a dark, dry, cool place. Avoid extended
exposure to light. Upon removal from package, inspect the product to ensure
no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature. Refer to your local Cook sales representative for
information on available literature.
NATHANSON LEVERRETRAKTORER
FORSIGTIG: I henhold til amerikansk lovgivning må dette produkt kun
sælges til en læge (eller en autoriseret behandler) eller efter dennes
anvisning.
BESKRIVELSE AF PRODUKTET
Nathanson leverretraktorer består af rustfrit stål og er anodiseret for at
eliminere lysrefleksion. Produktet fås i to størrelser.
3
ENGLISH
DANSK