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Merit Medical Flex-Neck ExxTended Catheter User Manual

Page 3

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marked by the Flex-Neck exxTended catheter Implantation

Stencils, in the clinic or during pre-op evaluation. at a

minimum, the patient should be evaluated preoperatively

to determine a proper, accessible location for the catheter

exit site. These marking should be noted for reference during

implantation.

3. The implanting physician should use the Flex-Neck exxTend-

ed catheter Stencils (included with each catheter pack) to verify

the primary implantation site, the upper catheter tunnel track,

and the exit-site, as previously chosen and marked in the clinic

or pre-op evaluation.

4. For upper chest catheter exit-site procedures, the implant-

ing physician will keep the subcutaneous part of the catheter

and the catheter exit-site off the sternum. doing so will protect

the integrity of the catheter in the event of future cardiovascular

surgery that may require a midline sternotomy.

outer

Inner

overall length,

Fill

diameter diameter

Straightened,

Volume

untrimmed


5.1 mm

3.5 mm

62.0 cm (lower cath)

maximum: 12.0 ml

62.0 cm (upper cath)

To find fill volume of

Must be trimmed to fit

trimmed, joined

patient physique and

catheter, multiply

exit-site location.

total length of joined

catheter (in cm) by

0.096 to get fill

volume in cc.

section a

InstructIons for flex-neck exxtended catheter

ImPlantatIon stencIl set

The Implantation Stencils for Flex-Neck exxTended peritoneal

dialysis (pd) catheters help choose the best implantation and

exit- sites for each patient. Note that these Implantation Stencils

cannot be used with other brands of pd catheters, or with other

sizes or styles of Flex-Neck pd catheters.

For best results, the Implantation Stencils can also be used

during operative preparations, to mark, coordinate, verify and/or

adopt the markings made during the preoperative examination

as needed after laparoscopic visualization of the peritoneal

space. please refer to the complete “Implantation Stencils for

Flex-Neck exxTended catheter Instructions for use” distributed

by merit medical Systems, for more information.

The Stencil pattern contains essential catheter design infor-

mation including the distance between the deep cuff and the

coil-tip, the shapes of preformed tubing bends, and the distance

between the superficial cuff and the exit-site. additional

features of the Stencil permit its precise orientation on the torso,

according to stable anatomical landmarks: the pubic symphysis,

representing the anterior cranial border of the deep pelvis, and

the anatomical midline of the torso. The Stencils permit accurate

and reproducible association of the catheter design elements

to these vital anatomical landmarks to help determine the

best catheter insertion site and deep cuff placement that will

produce the optimal pelvic position of the catheter coil and the

ideal exit-site location, either in the upper abdomen below the

costal margin, or in the upper chest off the sternum.

note:

each exxTended catheter kit includes three Stencils. each Stencil

has a reverse side for right (r) and left (l) catheter placements.

l-1, l-2 and r-1, r-2 are used for upper abdomen catheter

placement. l-1, l-3 and r-1, r-3 are used for upper chest

catheter placements.

cautIon

These exxTended Implantation Stencils are specific for oNlY

Flex-Neck exxTended adult peritoneal dialysis catheters.

• do NoT use these Stencils for other catheter brands.

• do NoT use these Stencils for Flex-Neck classic or arc™

catheters, in adult, adolescent, pediatric, or Infant sizes.

• do NoT resterilize these Stencils

• Stencils are available through merit medical Systems., Inc.

Patient marking in the surgical suite – upper abdomen and

upper chest

note:

These instructions are for marking the exxTended catheter

upper chest and upper abdomen configurations.

The following instructions are specific for implanting the

exxTended catheter on the patient’s left side. If the exxTended

catheter is to be implanted on the patient’s right side, substitute

the r-Series Stencils.

upper abdomen stencil Instructions

align the midline edge of the l-1 Stencil on the patient’s abdom-

inal midline. adjust the Stencil caudally or cranially to position

the notched cutout on the upper border of the pubic symphysis.

This will be the location of the upper extent of the catheter coil

as it lies in the pelvis. See Figure 1.

Figure 1

With the Stencil aligned on the patient’s midline, and the

notched cutout positioned as above, mark the T-bar cutout

which indicates the location of the primary incision site through

which the lower catheter will be inserted during the implan-

tation procedure and specifies the final resting position of the

rectus cuff.

1. align the midline edge of the l-2 Stencil with the midline

of the patient’s abdomen. adjust the Stencil up or down until

exit-site circle cutout is in desired position according

to pre-procedural patient markings. confirm that the upper

edge of the catheter tunnel track, or arcuate bend, is below the

costal margin. If the subcutaneous path indicated by the Stencil

overlaps the costal margin, then shift the Stencil caudally until

the rib margin is cleared. The midline edge of the Stencil should

remain parallel to the patient’s midline but may not exactly

coincide with midline due to lateral shift from weight of skin.

mark the exit-site circle with the Stencil in this position.

See Figure 2.

Figure 2

confirm that selected exit-site does not conflict with belt line,

skin creases or folds. exit site should be easily visible to the

patient as indicated by pre-procedural consultation and

markings.