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Merit Medical Flex-Neck Classic ARC Catheter User Manual

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NOTE: The Classic and ARC Stencil cannot be used with

other brands of PD catheters, or with other sizes or styles of

Flex-Neck PD Catheters.

Flex-Neck Classic and ARC Coiled Adult Catheters are each

available in three sizes – Small, Standard, and Large. The

notched cutouts (Small, Standard, and Large) apply to both

Classic and ARC catheter styles. The exit-site options for the

various sizes of catheters are denoted by circles 1-5.

ALWAYS verify that all location choices and markings are

not at belt lines, skin fold apexes, or blind sides of skin

folds, and that the patient is able to see and reach the

proposed exit-site.

The Flex-Neck ExxTended Catheter is highly recommend-

ed for patients who are not candidates for the Classic or

ARC catheter, according to the stencil exit-site markings.

Please consult Exxtended Catheter Instructions for Use for

additional information.

For all Classic Catheters, do not make the arcuate bend too

acute. If the bend is too acute, the catheter may migrate;

the exit cuff may erode; and/or a kink may occur occluding

the catheter. For all ARC Catheters, do not attempt to

change the preformed arcuate bend; doing so will greatly

increase the risk of catheter migration.

INSTRUCTIONS FOR STENCIl USE

Pre-Procedure Stencil Marking

The Stencils can be used in the clinic prior to the scheduled

implantation or on the day of the implantation procedure

in the surgical suite as part of the preoperative prepara-

tions. Proper Stencil use is done in 2 to 3 stages, first with

the patient supine, and then with the patient sitting and/

or standing.

1. Determine from OR staff which Flex-Neck Catheter size

and style will be implanted in the patient.

2. Based on the chosen size and style, with the patient

supine, align the Stencil on the patient’s midline, with

the appropriate notched cut-out placed on the

upper border of the public symphysis. See figure A.

3. With the Stencil located properly based on the chosen

catheter, mark the T-bar cutout , which is the

location of the primary incision site and the rectus cuff.

Mark the Rectangles cutout which indicate the

tunnel track.

4. Choose the most appropriate exit-cuff location, as

indicated by the Diamond cutout , and exit-site

location, as indicated by the Circle cutout , as appro-

priate both to patient physique and chosen catheter size

and style.

5. Verify the markings with the patient supine, sitting, and

standing. This ensures that the markings, and the cathe-

ter placement locations that they indicate, will be ideally

located and readily visible and accessible to the patient.

figure A

Stencil Marking in

the Surgical Suite

Sterile Stencils are

included in each

Flex-Neck catheter kit.

If no patient marking was done in advance in the clinic,

the Stencil can be used during the procedure, particularly

after laparoscopic or peritoneoscopic visualization of the

peritoneum to:

• Coordinate and verify the location choices

and markings.

• Adapt or adjust those markings, if necessary.

1. Determine from OR staff which Flex-Neck Catheter size

and style will be implanted in the patient.

2. Based on the chosen size and style, with the patient

supine, align the Stencil on the patient’s midline, with

the appropriate notched cut-out placed on the

upper border of the public symphysis.

3. With the Stencil located properly based on the chosen

catheter, mark the T-bar cutout , which is the

location of the primary incision site and the rectus cuff.

Mark the Rectangles cutout which indicate the

tunnel track.

4. Choose the most appropriate exit-cuff location, as

indicated by the Diamond cutout , and exit-site

location, as indicated by the Circle cutout , as appro-

priate both to patient physique and chosen catheter size

and style.

Flex-Neck Catheter Options:

Style, Size and location

ARC Catheter Options: Size and location

ARC

Coil

Exit-Site Exit-Cuff

Catheter Size

Location

Location

Location

Adult Small

Small

5

ARC

Adult Standard

Standard

5

ARC

Adult Large

Large

5

ARC

Classic Catheter Options: Size and location

Classic

Coil

Exit-Site Exit-Cuff

Catheter Size

Location

Location

Location

Adult Small

Small

1 or 2

Small

Adult Standard

Standard

2 or 3

Standard

Adult Large

Large

3 or 4

Large

INSTRUCTIONS FOR USE

CAThETER IMPlANTATION

Flex-Neck Peritoneal Dialysis Catheters can be implanted

via a number of implantation methods according to stan-

dard hospital protocols, including:

• Peritoneoscope

• Laparoscopy

• Surgery (Open; Blind; Cut-down)

• Percutaneous (with or without fluoroscopy; with or

without guide wire)

For specific instructions, please consult Instructions for Use,

included with all Merit peritoneal dialysis catheter Implan-

tation System Kits (sold separately).

CAUTIONS: Use the radiopaque stripe as a guide to keep

the Flex-Neck catheter straight. The catheter must not be

twisted or rotated during the implantation procedure. Any

twist or rotation in the catheter can lead to kinks, migra-

tion, and/or occlusion.