Merit Medical Titanium Catheter Connector - Manual (Page 2)

TwO-PIECE
TITANIUM CATHETER CONNECTOR
CC-2300
English
For use with Flex-Neck® Adult, Adolescent, Pediatric and
ExxTended Catheters ONLY
PRODUCT DESCRIPTION
Each box contains one (1) pouch with two piece Titanium
Connector. Includes main connector body and cap.
body cap
INDICATIONS FOR USE
The two-piece titanium peritoneal dialysis catheter connec-
tor is used to connect the peritoneal dialysis catheter to the
dialysate line.
CONTRAINDICATIONS FOR USE
Do NOT use with Flex-Neck Infant Peritoneal Dialysis
Catheters. Do NOT use with other peritoneal dialysis
catheter brands.
Px Only: CAUTION: Federal (USA) law 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-
infection, 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
• Leakage (initial or latent)
• Catheter separation from the connector
CAUTIONS
• 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 repeatedly in the same area.
• Do NOT clamp near the connector.
A
B
INSTRUCTIONS FOR USE
1. Create a sterile field for the procedure:
Prepare the patient’s skin and catheter with a cleaning or
disinfecting solution as needed, as per hospital protocol.
Drape the catheter exit-site area in an appropriate manner.
2. If clamping the catheter tubing with sterile hemostats or
forceps, use only smooth-jawed forceps or equivalent. Do
not use forceps with a serrated jaw. See cautions.
3. If replacing an existing connector, prepare the existing
Flex-Neck Catheter:
• Cut catheter tubing just distal to the existing connector
with sterile suture scissors, in a single, straight, perpen-
dicular cut. Do not pull the connector off the catheter.
• There must be at least 2.5 cm of catheter tubing remain-
ing after trimming.
• Verify that the cut is perpendicular to the tubing.
4. Slide the Titanium Connector Cap of the over the cathe-
ter, with the tapered end first.
5. Insert the tip of the connector’s Main Body into the
catheter and advance until only the knob (A) of the Main
Body is covered by the catheter as indicated by the arrow
in diagram.
• Do NOT advance past the knob (A) onto the neck (B).
• If necessary, wet the tapered tip (A) of the Connector
with sterile saline or sterile water before inserting it into
the catheter.
• Do not use any other lubricant.
• Do not use a twisting motion to force the catheter onto
the Connector. Push the Connector into the catheter
with a single forward motion.
6. Slide the Cap up and onto the main body and screw the
two parts snugly together by rotating the cap. There must
be no gap between the two parts of the connector, the Cap
and the Main Body.
• Do NOT rotate the Main Body of the connector; the
catheter may become twisted.
7. Pull carefully on the Replacement Connector and cathe-
ter to test the strength of the connection.
8. Attach either a connector cap, or a dialysis transfer set, to
the threaded luer end of the Main Body.
CATHETER ClEANINg AND CARE
All Flex-Neck Peritoneal Dialysis Catheters are made of
silicone. Exit-site cleaning agents that are compatible with
silicone catheters therefore may be acceptable for use
on Flex-Neck Peritoneal Dialysis Catheters. Such cleaning
agents include:
• Electrolytically-produced sodium hypochlorite solutions
(i.e., ExSept Plus®)
• Normal (sterile) saline
Cleaning agents that are non-irritating, non-toxic, anti-
bacterial, and in liquid form are generally recommended.