Merit Medical PD Catheter Repair Kit IFU User Manual

Page 3

INSTRUCTIONS FOR USE

1. Create a sterile field for the procedure:

• Prepare the patient’s skin and existing catheter with a

cleaning or disinfecting solution as per hospital protocol.

• Drape the catheter exit-site area in an appropriate man-

ner.

2. If clamping the existing catheter or Repair Catheter

Tubing (C) with sterile hemostats or forceps, use only

smooth-jawed forceps or equivalent. Do not use forceps

with a serrated jaw; see cautions.

3. Prepare the existing Flex-Neck Peritoneal

Dialysis 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. Select the appropriate Tube-to-Tube Connector, based

on the size of the existing catheter:

• Tube-to-Tube Connector (A) for all Flex-Neck Adult,

Adolescent and Pediatric Catheters

• Tube-to-Tube Connector (B) for all Flex-Neck Infant Cath-

eter

5. Flush and rinse the Repair Kit components with sterile

saline.

6. Wet the tapered tip of the appropriate Tube-to-Tube

Connector (A or B) with sterile saline or sterile water and

insert it into Repair Catheter Tubing (C).

• Do not use a twisting motion to force the Tubing onto

the Connector. Push the Connector into the Tubing with

a single forward motion.

• If Infant Tube-to-Tube Connector (B) is used, insert the

wider end of the Connector into Repair Catheter Tubing

(C). See Figure 2.

7. Advance the Repair Catheter Tubing (C) completely to

the raised ring barrier of Tube-to-Tube Connector (A) or (B).

See Figure 1 or 2, as appropriate. Pull carefully on Tube-to-

Tube Connector (A or B) and Repair Catheter Tubing (C) to

test the strength of the junction.

8. Wet the tapered tip of the Catheter Connector (D) with

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

end of the Repair Catheter Tubing (C). Advance the tube

completely to the Connector’s raised shoulder ridge. The

catheter tubing must completely pass over the Tapered

Tip and to the Raised Shoulder Ridge, but not beyond that

onto the Finger Grip. See Figures 3 and 4. Pull carefully

on the Catheter Connector and Repair Tube to test the

strength of the junction.

• Do not use a twisting motion to force the Tubing onto

the Connector. Push the Connector into the Tubing with

a single forward motion.

9. Wet the remaining tapered tip of the Tube-to-Tube Con-

nector (A or B) in sterile saline or sterile water and carefully

insert it into the original, existing catheter. Advance the

catheter end completely to the raised ring barrier of the

Connector. See Figure 1 or 2, as appropriate. Pull carefully

on the catheter and connector to test the strength of the

junction.

• CAUTION: Do NOT dislodge the cuffs.

• Do not use a twisting motion to force the catheter onto

the Tube-to-Tube connector. Push the Tube-to-Tube

connector into the catheter with a single forward

motion.

10. Attach either Cap (E), or a dialysis transfer set, to the

threaded luer end of Catheter Connector (D).

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 and repaired cathe-

ters. 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 specific 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 affiliates.