Merit Medical Centros FLO IFU - Manual (Page 5)

rotating collar
NOTE: Use only the clamps provided on the extension sets.
9. Extend tunneling sleeve fully and slide the catheter tips into sleeve
as far as possible.
NOTE: There is a slight interference fit between catheter and the
tunneling sleeve.
10. Insert the tunneler into the exit site and into the subcutaneous
tissue. Create a short subcutaneous tunnel. DO NOT tunnel through
muscle. Advance the tip of the tunneler through the lateral portion
of the incision.
WARNING: Do not over-expand the subcutaneous tissue during
tunneling. Over-expansion may delay or prevent cuff in-growth.
11. Pull and push the tunneling sleeve into the tunnel gently until the
tip of the sleeve emerges from the primary incision. Push the catheter
through the tunnel while pulling the sleeve from primary incision.
12. Using small hemostats, compress the cuff and push through the
exit site while pulling gently on the catheter.
CAUTION: DO NOT pull tunneler out of the primary incision at an
angle. Keep tunneler straight to prevent damage to the catheter tip.
The catheter can be bent slightly.
CAUTION: The tunnel should be made with care to avoid damage to
surrounding vessels. Avoid tunneling through muscle.
NOTE: A tunnel with a gentle arc lessens the risk of kinking. The
tunnel should be short enough to keep the hub of the catheter from
entering the exit site, yet long enough to keep the cuff 2 cm
(minimum) from the skin opening.
NOTE: For alternate insertion methods, see the OVER-THE-WIRE
TECHNIQUE section.
INTRODUCTION OF THE VALVED PEELAWAY INTRODUCER:
PRECAUTIONS:
• Dilators and catheters should be removed slowly from the sheath.
Rapid removal may damage the valve membranes resulting in
blood flow through the valve. Never advance or withdraw guide-
wire or sheath when resistance is met. Determine cause by fluoros-
copy and take remedial action.
CAUTION: The sheath is not intended to create a complete two-way
seal nor is it intended for arterial use.
CAUTION: The sheath is designed to reduce blood loss but it is not
a hemostasis valve. The valve may substantially reduce the rate of
blood flow, but some blood loss through the valve may occur.
1. Close the valve on peelaway sheath then insert the dilator through
the valve and lock in place using the rotating collar. NOTE - Optional
dilation:
• To ease insertion of the peelaway introducer, some physicians
prefer to dilate the vein before inserting the introducer.
• Thread the blue dilator(s) over the end of the guidewire and ad-
vance into the vein using a rotating motion to assist passage through
the tissue.
CAUTION: As the dilator(s) pass through the tissue and into the
vasculature, ensure that the guidewire does not advance further into
the vein.
2. While maintaining guidewire position in the vein, advance the
locked peelaway introducer and dilator assembly over the exposed
guidewire and into the vein.
WARNING: Never leave the sheath in place as an indwelling catheter.
Damage to the vein will occur.
3. Hold the sheath in place and unlock the dilator assembly by turn-
ing the rotating collar. Gently withdraw the dilator and wire from the
sheath leaving the valved introducer in place.
NOTE: Leaving the guidewire in place after removing the dilator may
cause the valve to leak.
CAUTION: Care should be taken not to advance the peelaway sheath
too far into the vessel as a potential kink would create an impasse to
the catheter.
DIALYSIS CATHETER PLACEMENT:
1. Squeeze the two limbs of the catheter
together and advance the distal section of the catheter through the
valved sheath introducer and into the vein.
PRECAUTION: To help minimize catheter kinking, it may be necessary
to advance in small steps by grasping the catheter close to
the sheath.
2. Advance the catheter tip to appropriate site as noted in the
“insertion sites” section.
3. With the catheter advanced and positioned, crack the sheath
handle in half and peel partially away from the catheter.
4. Near the valve, hold the catheter firmly in position and pull the
valve off the catheter.
PRECAUTION: It is normal to experience some resistance while
pulling the catheter through the slit on the valve.
CAUTION: Do not pull apart the portion of the sheath that remains in
the vessel. To avoid vessel damage, pull back the sheath as far as
possible and peel the sheath only a few centimeters at a time.
5. Remove the sheath completely from the patient and catheter.
6. Press the remaining catheter loop (“knuckle”) gently into the
subcutaneous pocket created at the venous entry site.
7. Observe the apex of the catheter at the primary incision. If a kink
is visible, dilate beneath the catheter using hemostats to create a
pocket for the catheter apex.
WARNING: Catheters should be implanted carefully to avoid any
sharp or acute angles which could compromise the flow of blood or
occlude the opening of the catheter lumens.
Hold catheter in position
pull valve and
sheath off