Merit Medical Flex-Neck Classic ARC Catheter - Manual (Page 2)

Flex-Neck® Classic and ARC™
Peritoneal Dialysis Catheters
English
PRODUCT DESCRIPTION
Each Flex-Neck Catheter package contains:
• Flex-Neck Peritoneal Dialysis Catheter
• Implantation Stencil (for left and right sided placement)
• Plastic Connector and Cap
• Lubricating Gel
INDICATIONS FOR USE
ClASSIC
If the patient is a suitable candidate for Peritoneal Dialysis
(PD) therapy, the Flex-Neck PD Catheter can be implanted
either surgically or peritoneoscopically. The only contraindi-
cation to implantation of the Flex-Neck PD Catheter is if the
patient is not a candidate for peritoneal dialysis. Numerous
prior surgeries or suspected or documented intraperitoneal
adhesions may be relative contraindications to PD. Howev-
er, since the Y-TEC® System of peritoneoscopic implantation
enables inspection of the peritoneum to confirm the
presence of adhesions and to avoid them, all patients who
are suitable for PD can receive this catheter.
ARC
If a patient is a suitable candidate for PD therapy, the
Flex-Neck ARC peritoneal dialysis catheter can be implant-
ed either surgically, laparoscopically, or peritoneoscopically
for acute or chronic peritoneal dialysis.
INFANT
If the patient is a suitable candidate for PD therapy and is
too small for the current Flex-Neck catheters, the Flex-Neck
Catheter, Infant, can be implanted either surgically, perito-
neoscopically or percutaneous. The only contraindication
to implantation of the Flex-Neck PD Catheter, Infant is if the
patient is not a candidate for peritoneal dialysis.
CONTRAINDICATIONS
Do NOT use if the patient is not a suitable candidate for
peritoneal dialysis therapy.
Px Only: CAUTION: Federal law (USA) restricts this device
to sale by or on the order of a physician.
PRECAUTIONS
• Read manufacturer’s instructions prior to use.
• Contents are sterile (via ethylene oxide). Do not use if
packaging is opened, damaged or broken.
• For single patient 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-in-
fection, 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 use after expiration date.
• The medical techniques, procedures and potential com-
plications stated herein do NOT give full and/or com-
plete coverage or descriptions. They are not a substitute
for adequate training and sound medical judgment by a
physician.
• Use an aseptic procedure to open the package and to
remove the contents.
POTENTIAl COMPlICATIONS
• Infections (exit-site or tunnel)
• Peritonitis
• Sepsis
• Bowel Perforation
• Leakage (initial or latent)
• Fluid flow obstruction (inflow or outflow)
• Bleeding (subcutaneous or peritoneal)
• Ileus
• Proximal exit cuff erosion
• Distal (rectus/deep) cuff erosion
• Risks normally associated with peritoneoscopic and
laparoscopic procedures.
CAUTIONS
• Do no twist or rotate catheter during the implantation
procedure.
• This Stencil cannot be used with other brands of PD
catheters, or with other sizes or styles of Flex-Neck PD
Catheters.
• This Stencil is designed for, and to be used with, Flex-
Neck Classic and ARC Coiled Adult Peritoneal Dialysis
Catheters ONLY.
• Do NOT use the Classic and ARC stencil with Flex-Neck
Adolescent, Pediatric, Infant, or ExxTended™ Catheters.
• Do NOT use this Stencil with other catheter brands.
• Do NOT sterilize this Stencil.
• Catheter tubing can tear when subjected to repeated
clamping, serrated-jaw forceps, excessive force, or rough
tools.
• Do NOT use forceps with a serrated jaw.
• Do NOT use excessive force to lock the forceps closed.
• Use ONLY smooth-jawed forceps or equivalent.
• Do NOT clamp the catheter, or repair tubing repeatedly
in the same area.
• Do NOT clamp near the connector.
Use only catheter connectors and repairs kits which are
specifically labeled and approved for use with Flex-Neck
Peritoneal Dialysis Catheters. Approved catheter connec-
tors and repair kits can be ordered directly from Merit
Medical Systems, Inc.
For best results, use the Stencils included with each
catheter kit. If not using the included Stencils, follow
generally accepted standard hospital protocols to make
arcuate-shaped tunnels.
For Implantation Stencils
Implantation Stencils for Classic and ARC and Adult Coiled
Peritoneal Dialysis Catheters can be used to indicate the
optimum implantation site, exit-site, catheter size, and
catheter style for each patient. The stencil will help choose
the best primary incision site, coil location, rectus cuff
location, tunnel track, and exit-site location in advance of
the implantation procedure.
For Tunneling Stencils
Tunneling stencils are included with Flex-Neck Adult
Straight, Adolescent, Pediatric and Infant Catheters.
Tunneling stencils will help choose the best tunnel track for
the catheter.
General Instructions for Classic and
ARC Implantation Stencils
Implantation stencils utilize fixed anatomical landmarks,
such as the pubic symphysis and the midline, to guide
accurate and reproducible skin marking, in the clinic or
pre-op evaluation suite. Please consult Stencil Instructions
for Use (distributed by Merit Medical) for patient marking in
the PD outpatient clinical setting.