Device Description; Indications For Use; Contraindications - MedComp Symetrex Mode D'emploi

WARNING
This catheter is for single product and patient use only. DO NOT REUSE,
REPROCESS OR RESTERILIZE. Reuse of a single use device carries with it
the potential risk of contamination of the device and/or risk of patient/user
infection or cross infection including but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination, cross-
contamination and/or cross-infection may lead to injury, illness, or death
of the patient. Re-sterilization or Reprocessing of the device may not be
effective and may compromise the structural integrity of the device and/
or lead to device failure, which in turn may lead to patient injury, illness or
death. The manufacturer shall not be liable for any damages caused by reuse,
reprocessing or re-sterilization of this device or accessories. Federal (USA) law
restricts this device to be used by or under the direction of a physician.

DEVICE DESCRIPTION

The Symetrex® Long Term Hemodialysis Catheter is a chronic,15.5 French,
dual lumen, radiopaque catheter made of polyurethane. It has a polyester
retention cuff and two female luer adapters. The retention cuff promotes
tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer
adapters are identical in color to indicate the reversibility of this catheter. This
catheter features symmetrical side channels with a distal tip configuration
designed to separate the intake flow from the output flow in both directions.
RECIRCULATION RATES
The Symetrex® Long Term Hemodialysis Catheter has less than 1%
recirculation in Forward and Reverse flow when tested in vitro.
FLOW RATE VS. PRESSURE PROFILE
The Flow Rate vs. Pressure profile of the Symetrex® Long Term Hemodialysis
Catheter is presented below:
Flow Rate vs. Pressure Data was obtained in vitro using a glycerin/water analog
with a viscosity of ≈2.75 cP.

INDICATIONS FOR USE

The Symetrex® Long Term Hemodialysis Catheter is a symmetric tip dual
lumen catheter designed for chronic hemodialysis and apheresis. It may be
inserted percutaneously or by cut down. Catheters with greater than 37 cm
implant length are indicated for femoral placement.

CONTRAINDICATIONS

Do not use this catheter in thrombosed vessels or for subclavian puncture
when ventilator is in use.
This device is contraindicated whenever:
• Used for any purpose other than indicated in these instructions.
• The presence of other device related infection, or septicemia is known or
suspected.
• Severe chronic obstructive lung disease is present.
• Tissue factors in the localized area of device placement will prevent
proper device stabilization and/or access.
• Venous thrombosis or vascular surgical procedures have occurred at the
prospective placement site.
• Post irradiation of prospective insertion site.
WARNINGS & GENERAL PRECAUTIONS
• Health care professionals should always use universal blood and body
fluid precautions in the care of all patients to minimize the risk of
exposure to HIV (Human Immunodeficiency Virus) or other blood borne
pathogens. Sterile technique must be strictly adhered to during any
handling of the device.
• The risk of infection is increased with femoral vein insertion.
• To minimize the risk of air embolism or extravasation, keep the catheter
clamps closed at all times when not in use or when attached to a syringe,
IV tubing, or bloodlines.
• Peel-away introducer must only be advanced over a guidewire.
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