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Titanium Catheter Connector Instructions for Use

Titanium Catheter Connector Instructions for Use

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Published by: Merit Medical Systems on Sep 18, 2013
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06/23/2014

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INSTRUCTIONS FOR USE
 Two-Piece TITANIUM CATHETERCONNECTORCC-2300
For use with Flex-Neck® Adult, Adolescent,Pediatric and ExxTended Catheters ONLY
 
 
TwO-PIECETITANIUM CATHETER CONNECTORCC-2300
EnglishFor use with Flex-Neck® Adult, Adolescent, Pediatric andExxTended Catheters ONLY
PRODUCT DESCRIPTION
Each box contains one (1) pouch with two piece TitaniumConnector. 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 thedialysate line.
CONTRAINDICATIONS FOR USE
Do NOT use with Flex-Neck Inant Peritoneal DialysisCatheters. Do NOT use with other peritoneal dialysiscatheter brands.
PxOny: CAUTION
: Federal (USA) law restricts this deviceto sale by or on the order o a physician.
PRECAUTIONS
Read manuacturer’s instructions prior to use.Contents are sterile (via ethylene oxide). Do not use i packaging is opened, damaged, or broken.For single patient use only. Do not reuse, reprocess, orresterilize. Reuse, reprocessing, or resterilization maycompromise the structural integrity o the device and/or lead to device ailure, which in turn may result inpatient injury, illness, or death. Reuse, reprocessing orresterilization may also create a risk o contamination o the device and/or cause patient inection or cross-inection, including, but not limited to, the transmissiono inectious disease(s) rom one patient to another.Contamination o the device may lead to injury, illness,or death o the patient.Do not use ater expiration date.The medical techniques, procedures and potential com-plications stated herein do NOT give ull and/or com-plete coverage or descriptions. They are not a substituteor adequate training and sound medical judgment by aphysician.Use an aseptic procedure to open the package and toremove the contents.
POTENTIAl COMPlICATIONS
Inections (exit-site or tunnel)• Peritonitis• SepsisLeakage (initial or latent)Catheter separation rom the connector
CAUTIONS
Catheter tubing can tear when subjected to repeatedclamping, serrated-jaw orceps, excessive orce, or roughtools.Do NOT use orceps with a serrated jaw.Do NOT use excessive orce to lock the orceps closed.Use ONLY smooth-jawed orceps 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 eld or the procedure:Prepare the patient’s skin and catheter with a cleaning ordisinecting solution as needed, as per hospital protocol.Drape the catheter exit-site area in an appropriate manner.2. I clamping the catheter tubing with sterile hemostats ororceps, use only smooth-jawed orceps or equivalent. Donot use orceps with a serrated jaw. See cautions.3. I replacing an existing connector, prepare the existingFlex-Neck Catheter:Cut catheter tubing just distal to the existing connectorwith sterile suture scissors, in a single, straight, perpen-dicular cut. Do not pull the connector o the catheter.There must be at least 2.5 cm o catheter tubing remain-ing ater trimming.Veriy that the cut is perpendicular to the tubing.4. Slide the Titanium Connector Cap o the over the cathe-ter, with the tapered end rst.5. Insert the tip o the connector’s Main Body into thecatheter and advance until only the knob (A) o the MainBody is covered by the catheter as indicated by the arrowin diagram.Do NOT advance past the knob (A) onto the neck (B).I necessary, wet the tapered tip (A) o the Connectorwith sterile saline or sterile water beore inserting it intothe catheter.Do not use any other lubricant.Do not use a twisting motion to orce the catheter ontothe Connector. Push the Connector into the catheterwith a single orward motion.6. Slide the Cap up and onto the main body and screw thetwo parts snugly together by rotating the cap. There mustbe no gap between the two parts o the connector, the Capand the Main Body.Do NOT rotate the Main Body o the connector; thecatheter may become twisted.7. Pull careully on the Replacement Connector and cathe-ter to test the strength o the connection.8. Attach either a connector cap, or a dialysis transer set, tothe threaded luer end o the Main Body.
CATHETER ClEANINg AND CARE
All Flex-Neck Peritoneal Dialysis Catheters are made o silicone. Exit-site cleaning agents that are compatible withsilicone catheters thereore may be acceptable or useon Flex-Neck Peritoneal Dialysis Catheters. Such cleaningagents include:Electrolytically-produced sodium hypochlorite solutions(i.e., ExSept Plus®)Normal (sterile) salineCleaning agents that are non-irritating, non-toxic, anti-bacterial, and in liquid orm are generally recommended.
 
 The ollowing cleaning agents are not compatible withsilicone catheters, and are not recommended or use withFlex-Neck Peritoneal Dialysis catheters:Acetone or acetone-based productsPovidone-iodine or iodine-based productsMerit Medical Systems, does not provide specic recom-mendations or protocols or exit-site care and cleaning,whether by the healthcare proessional or by the patient.Appropriate exit-site and catheter care treatment protocolsshould be individualized or each patient, and establishedby the patient’s physician(s), nurse(s), dialysis center(s),and/or other relevant dialysis healthcare proessionals.ExSept Plus is a registered trademark o Alcavis HDC, LLC orone o its afliates.Copyright © Merit Medical Systems, Inc. All rights reserved.
Manufacturer:Merit Medical Systems, Inc.1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A.1-801-253-1600 U.S.A. Customer Service 1-800-356-3748Authorized Representative:Merit Medical Ireland Ltd,Parkmore Business Park West, Galway, Irelandwww.merit.com
ID 060513 402899001/A

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