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REPLACEMENT

CONNECTOR AND CAP KIT

CC-1360 English

For Flex-Neck® Infant Peritoneal Dialysis Catheters ONLY

PRODUCT DESCRIPTION

Replacement Connector and Cap Kit for Flex-Neck® Infant

Catheters only.

Each pouch contains one Connector and one Cap.

• Tapered Tip (A) A

• Raised Shoulder Ridge (B)

• Finger Grip (C)

• Threaded Luer (D)

• Cap (E) E

INDICATIONS FOR USE

The replacement Connector and Cap are indicated ONLY for

Flex-Neck Infant Peritoneal Dialysis Catheters, to be used

when a patient needs a replacement Connector and Cap.

CONTRAINDICATIONS FOR USE

Do NOT use with Flex-Neck Adult, Adolescent, or Pediatric

Peritoneal Dialysis Catheters. Do NOT use with other peri-

toneal dialysis catheter brands.

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-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

• 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.

INSTRUCTIONS FOR USE

1. Create a sterile eld for the procedure:

• Prepare the patient’s skin and catheter with a

cleaning or disinfecting solution as needed 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 as damage may

occur. See cautions.

3. Prepare the existing Flex-Neck Infant Peritoneal Dialysis

Catheter:

• Cut catheter tubing just distal to the existing

connector with sterile suture scissors, in a single,

straight, perpendicular cut. Do not pull the connector

o the catheter.

• There must be at least 2.5 cm of catheter tubing

remaining after trimming.

• Verify that the cut is perpendicular to the tubing.

4. Wet the tapered tip (A) of the Replacement Connector

with sterile saline or sterile water, and insert it into the

catheter.

• Do not use any other lubricant.

• Do not use a twisting motion to force the catheter

onto the Replacement Connector.

5. Push the Replacement Connector into the catheter with

a single forward motion.

6. Advance the catheter completely to the raised shoulder

ridge of the Replacement Connector.

NOTE: The catheter tubing must completely pass over the

tapered tip (A) and to the raised shoulder ridge (B), but not

beyond that onto the nger grip (C). See diagram above.

7. Pull carefully on the Replacement Connector and

catheter to test the strength of the connection.

8. Attach either the Cap or a dialysis transfer set, to the

threaded Luer.

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.

The following cleaning agents are not compatible with

silicone catheters, and are not recommended for use with

Flex-Neck Peritoneal Dialysis catheters:

• Acetone or acetone-based products

• Povidone-iodine or iodine-based products

Merit Medical Systems, does not provide specic recom-

mendations or protocols for exit-site care and cleaning,

whether by the healthcare professional or by the patient.

Appropriate exit-site and catheter care treatment protocols

should be individualized for each patient, and established by

the patient’s physician(s), nurse(s), dialysis center(s), and/or

other relevant dialysis healthcare professionals.

ExSept Plus is a registered trademark of Alcavis HDC, LLC or

one of its aliates.