Bard vas-cath, Инструкция по эксплуатации

Страница: 3 / 44

1
‑‑‑ ‑
Instructions For Use
English
Repairs: Decathlon
®
DF Catheters, Equistream
®
Catheters,
Equistream ® XK Catheters, Flexxicon ®
Catheters, Flexxicon ® II Catheters, Glidepath ®
Catheters, HemoGlide ® Catheters, HemoSplit™
Catheters, HemoSplit™ XK Catheters, HemoStar ®
Catheters,
HemoStar
®
XK Catheters, Niagara™
Catheters,
Niagara™ Slim-Cath ®
Catheters,
Reliance XK™ Catheters and Soft-Cell ®
Catheters.
• Verify 4.5 cm of usable extension leg between
bifurcation and damaged area on extension leg
using measuring tape printed on instructions.
• If less than 4.5 cm usable length remains, do not
attempt repair.
Indications
To replace: Cracked or broken female luer lock
connectors or repair damaged extension where
there is a minimum of 4.5 cm of viable extension
tubing on the following catheters:
• Decathlon ® DF Long‑Term Dual Lumen Catheter
• Equistream ® Long‑Term Dual Lumen Catheter
• Equistream ® XK Long‑Term Dual Lumen Catheter
• Flexxicon ® Short‑Term Dual Lumen Catheter
• Flexxicon ® II Short‑Term Dual Lumen Catheter
• Glidepath ® Long‑Term Dual Lumen Catheter
• HemoGlide ® Long‑Term Dual Lumen Catheter
• HemoSplit™ Long‑Term Dual Lumen Catheter
• HemoSplit™ XK Long‑Term Dual Lumen Catheter
• HemoStar ® Long‑Term Dual Lumen Catheter
• HemoStar ® XK Long‑Term Dual Lumen Catheter
• Niagara™ Short‑Term Dual Lumen Catheter
• Niagara™ Slim-Cath ® Short‑Term Dual Lumen Catheter
• Reliance XK™ Long‑Term Dual Lumen Catheter
•
Soft-Cell
® Long‑Term Dual Lumen Catheter
Contraindications
• Do not use to repair catheters other than those
indicated above.
• Do not attempt connector replacement if usable
length of remaining connector extension tubing is
less than 4.5 cm.
• Do not replace connector if tubing is swollen or
displays signs of degradation.
Warnings
• Alcohol or alcohol-containing antiseptics (such
as chlorhexidine) may be used to clean the cath-
eter / skin site; however, care should be taken to
avoid prolonged or excessive contact with the
solution(s).
• Acetone and Polyethylene Glycol-containing
ointments can cause failure of this device
and should not be used with polyurethane
catheters. Chlorhexidine patches or bacitracin
zinc ointments (e.g., Polysporin
™ ointment)
are the preferred alternative.
• Intended for Single Use. DO NOT REUSE.
Reuse and/or repackaging may create a risk
of patient or user infection, compromise the
structural integrity and/or essential material
and design characteristics of the device,
which may lead to device failure, and/or lead
to injury, illness or death of the patient.
• Place all clamps near the center of the poly-
urethane extension pieces. Clamping near or
on the luer lock connectors may cause tubing
fatigue and possible disconnection.
• Polyurethane may develop cuts or tears if
subjected to excessive pulling or contact with
rough edges.
• Accessories and components used in con-
junction with this connector must incorporate
luer lock adapters in order to avoid inadver-
tent disconnection.
• The green slide clamp is provided for use
during the repair procedure only. DO NOT
REUSE the green slide clamp as it is not
permanently attached and could separate
from catheter, resulting in excessive bleeding.
Dispose of the green slide clamp following
the repair procedure.
• After use, this product may be a potential bio-
hazard. Handle and dispose of in accordance
with accepted medical practice and applicable
local, state and federal laws and regulations.
• Failure to clamp could lead to air embolism or
blood loss.
• ALL CATHETER REPAIRS ARE DONE AT THE
DISCRETION OF THE ATTENDING PHYSICIAN.
THE MANUFACTURER WILL NOT ASSUME
ANY LIABILITY FOR THE SAFETY OF A
CATHETER AS A RESULT OF CATHETER
REPAIR.
• Do not use heparin in patients with heparin
allergy.
Cautions
• Carefully read and follow all instructions prior
to use.
• Only qualified healthcare practitioners should
repair damaged catheters.
• Sterile and non‑pyrogenic only if packaging is
not opened, or broken. Sterilized with Ethylene
Oxide.
• Caution: Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician.
• Strict aseptic technique must be used during the
catheter repair procedure in accordance with
Centers for Disease Control and National Kidney
Foundation Clinical Practice Guidelines such as
sterile gloves, sterile gown, surgical masks and
caps (for patient and healthcare provider), and
large sterile sheet.1,3
• Be sure to pull on the extension tubing and the
connector only and not on the implanted portion
of the catheter.
• The priming volume of the repaired lumen will
decrease by 0.1 mL for initial repair and 0.5 mL
for every additional cm of extension tube removed.
(See priming volume worksheet on back of IFU).
• In the rare event of a leak, the catheter must
be clamped immediately. Necessary remedial
action must be taken prior to resuming dialysis
treatment.
Preparation of Patient and Catheter
1. Assemble supplies.
• Repair kit
• Large sterile drape that is able to cover
patient from head to toe, sterile gown, sterile
gloves (4 pair)
• Surgical masks (2) and caps (2) ‑ 1 of each
for both patient and healthcare provider
• Sterile 10 mL Luer‑Iock syringe x 2
• Povidone iodine solution
• Sterile 4 in. x 4 in. (10 cm x 10 cm) gauze
2. Patient and healthcare provider should don
mask and cap1,3. Healthcare provider should
observe proper hand hygiene2 and aseptically
don sterile gloves1.
3. Examine entire length of extension tubing for
damage. If the extension tubing is split, swollen,
has other damage, or the repairable portion
is shorter than 4.5 cm the catheter should be
replaced.
4. Starting at the bifurcation, use the measuring
tape provided on the left side of instructions to
measure the length of usable extension tubing
that will remain after connector and any dam‑
aged tubing are cut off. If the remaining tubing
length is 4.5 cm or greater, proceed with repair.
5. Use original thumb clamp to clamp off the cath‑
eter between the catheter bifurcation and the
damaged portion of the catheter.
6. Discard gloves.
7. Observe proper hand hygiene2 and don sterile
gloves aseptically1.
8. Soak the external segment of the catheter
extension legs in povidone iodine solution for 3
to 5 minutes2 using gauze. Ensure all exposed
catheter parts are cleaned. Discard gloves.
9. Don sterile gown and sterile gloves aseptically.
10. Open the sterile repair kit. Create sterile field
with CSR wrap provided. Add any additional
supplies.
CAUTION: Strict aseptic technique
must be used during the entire catheter repair
procedure.
11. Aseptically apply large sterile drape over
patient, exposing external segment of the cath‑
eter to be repaired.
12. Remove gauze and allow povidone iodine solu‑
tion to dry. Discard gloves.
Catheter Repair Procedure
1. Aseptically don sterile gloves.
2. Remove the connector cap from the affected
extension leg and aspirate any fluid in the exten‑
sion tubing, using the 10 mL Luer lock syringe.
3. Slide the green slide clamp, provided in the kit,
onto the extension tubing adjacent to the cath‑
eter bifurcation.
4. Using the scissors included in the kit cut off
the damaged connector/extension tubing at
a 90 degree angle. Make the cut as close to
the connector as possible. Measure removed
length of extension leg for future priming vol‑
ume calculation.
5. Replace existing thumb clamp with the appro‑
priate color‑coded (blue‑venous, red‑arterial)
thumb clamp, provided in the kit, and close the
clamp. It is important that the clamp is oriented
per figure 1. (Step A)
Step A
Temporary Use Only
Figure 1
6. Remove the green slide clamp. Replace green
slide clamp on the extension tubing between
the thumb clamp and the cut end of the tubing.
Bard Access Systems, Inc.
Catheter Repair Kit
With Replacement Connector
English