Merit Medical Centros FLO IFU - Manual (Page 6)

PRECAUTION: For optimal product performance do not insert any
portion of the cuff into the vein.
8. Attach syringes to both extensions and open the clamps. Confirm
correct placement and catheter function by aspirating blood from
both lumens. Blood should aspirate easily.
PRECAUTION: If either side exhibits excessive resistance to blood
aspiration, the catheter may need to be rotated or repositioned to
obtain adequate blood flows.
9. Once adequate aspiration has been achieved, both lumens should
be irrigated with saline filled syringes using quick bolus technique.
Assure that extension clamps are open during irrigation procedure.
10. Fill each lumen with heparinized saline (priming volume is printed
on the extension tubing I.D. tags).
11. Clamp the extensions immediately after flushing.
CAUTION: Ensure that extension set clamps are closed between uses.
12. Remove the syringes and replace with injection caps.
PRECAUTION: Avoid air embolism by keeping extension tubing
clamped at all times when catheter is not in use and by aspirating
then irrigating the catheter prior to each use. Always aspirate first
then irrigate the catheter prior to each use. With each change in
tubing connections, purge air from the catheter and all connecting
tubing and caps.
13. Correctly position the cuff and tunneled portion of the catheter.
14. Confirm proper tip placement with fluoroscopy.
15. Make any adjustments of catheter tip under fluoroscopy.
WARNING: Failure to verify catheter placement with fluoroscopy
may result in serious trauma or fatal complications.
16. Secure and dress the catheter as noted in “Secure Catheter and
Dress wound” section.
SECURE CATHETER AND DRESS WOUND:
17. Suture the catheter to the skin using the suture wing. Do not
suture the catheter tubing.
CAUTION: Care must be taken when using sharp objects or needles
in close proximity to catheter tubing. Contact from sharp objects may
cause catheter failure.
18. Cover the insertion and exit site with an occlusive dressing.
19. Catheter must be secured/sutured for entire duration
of implantation.
20. Record catheter length and catheter lot number on
patient’s chart.
WARNING: Confirm final position of catheter placement with
fluoroscopy or x-ray.
HEMODIALYSIS TREATMENT:
The heparinized saline solution must be removed from each lumen
prior to treatment to prevent systemic heparinization of the patient.
Aspiration should be based on dialysis unit protocol. Before dialysis
begins all connections to catheter and extracorporeal circuits should
be examined carefully. Tubing should be properly primed with saline.
Frequent visual inspection should be conducted to detect leaks to
prevent blood loss or air embolism. If a leak is found, the catheter
should be clamped immediately.
CAUTION: Only clamp extension sets with in-line clamps provided.
DO NOT clamp the catheter body tubing.
• Necessary remedial action must be taken prior to the continuation
of the dialysis treatment if a leak is detected.
NOTE: Excessive blood loss may lead to patient shock.
• Hemodialysis should be performed under physician’s instructions.
ANTICOAGULANT SOLUTION FOR THE CATHETER:
• If the catheter is not to be used immediately for treatment, follow
the suggested catheter patency guidelines.
• To maintain patency between treatments, heparinized saline or
other anticoagulant solution lock must be created in each lumen
of the catheter.
• Follow hospital protocol for heparinized saline concentration.
1. Draw solution into two syringes, corresponding to the amount
designated on the arterial and venous I.D. tags (as shown below).
Ensure that the syringes are free of air.
Priming Volumes
Lumen
Catheter Length (tip-to-cuff) Arterial (mL) Venous (mL)
15 Straight 1.7 1.8
17 Straight 1.8 1.8
19 Straight 1.8 2.0
23 Straight 1.9 2.0
27 Straight 2.2 2.2
31 Straight 2.3 2.4
2. Ensure that the extension set clamps are closed.
3. Remove sealing caps from the extensions.
4. Attach a syringe containing heparinized saline to the female luer
of each extension.
5. Open extension clamps.
6. Aspirate to ensure that no air will be forced into the patient.
7. Inject heparinized saline into each lumen using quick bolus
technique.
NOTE: Each lumen should be completely filled with heparinized
saline to ensure effectiveness.
8. Close extension clamps.
CAUTION: Extension clamps should only be open for aspiration,
flushing, and dialysis treatment.
9. Remove syringes.
10. Attach a sterile sealing cap onto the female luers of the extensions.
NOTE: No further anticoagulant solution is necessary between treat-
ments provided the lumens are not being aspirated or flushed.
SITE CARE:
WARNING: DO NOT use acetone or PEG-containing ointments of any
kind with this catheter.
• Clean skin around catheter. Cover the exit site with occlusive
dressing and leave extensions, clamps, and caps exposed for
access by staff.
• Wound dressings must be kept clean and dry.
CAUTION: Patients must not swim, shower, or soak dressing while
bathing.
• If profuse perspiration or accidental wetting compromises
adhesion of dressing, the medical or nursing staff must change
the dressing under sterile conditions.