40-5091-24B IFU PAC-PACII.indd - Smiths Medical

English (continued)
8
(Dual-lumen Low Profi le Figure 19: A – Catheter, B – Outlet tube housing)
WARNING: The catheter must be fl ush against the outlet tube housing before the
WING-LOCK® catheter connector is advanced. Improper attachment of the catheter
onto the portal may result in system leakage or disconnection of the catheter from
the portal.
6. Grasp the WING-LOCK® catheter connector and slowly advance it onto the outlet
tube housing, keeping the WING-LOCK® connector in the same horizontal plane
as the outlet tubes. DO NOT tip the WING-LOCK® catheter connector when
advancing it onto the outlet tube housing, as this could cause the outlet tubes to
damage the catheter.
(Figure 16: A – Outlet tube housing, B – Housing pin, C – Catheter)
(Dual-lumen Low Profi le Figure 20: A – Outlet tube housing, B – Housing pin,
C – Catheter)
7. Turn the WING-LOCK® catheter connector clockwise until the outlet tube housing
pins fi t inside the slots on the connector. Th en turn the catheter connector
approximately 1/4 turn clockwise until it snaps into place against the housing
pin. (Figure 17: A – WING-LOCK® catheter connector, B – Housing pin)
(Dual-lumen Low Profi le Figure 21: A – WING-LOCK® catheter connector,
B – Housing pin)
NOTE: You should feel and/or hear the WING-LOCK® catheter connector snap
into place.
NOTE: If you are unable to engage the WING-LOCK® catheter connector onto
the housing pins, you must remove the catheter and trim approximately 6
mm off the tip of the catheter. Then repeat steps 4–7.
8. Ensure that the catheter extends smoothly from the portal with suffi cient slack
to eliminate tension. Excessive slack may increase the possibility of kinking and
catheter fl exing which may cause catheter occlusion and/or fracture.
Proceed to Flow Check.
C. Flow Check
WARNING: Do not exceed a pressure of 40 psi [2.76 bar; 275 kPa ] when fl ushing fl uid
through the system. Excessive pressure may damage the system and can easily be
generated with power injectors or with all syringes. The smaller the syringe, the higher the
pressure that can be generated with the same applied force. Do not continue attempts to
fl ush the system if extreme resistance is encountered. Damage due to excessive pressure
may include but is not limited to, catheter rupture or fragmentation with possible
em bolization, or drug extravasation.
NOTE: Each chamber of the dual-lumen portal must be checked separately.
1. Stabilize the portal using the thumb and fi nger. Con fi rm that the fl ow is not
obstructed and that no leaks exist by fl ushing the system, using a non-coring
PORT-A-CATH® access needle and a 10-ml or larger syringe fi lled with heparin
solution (10 to 100 IU/ml).
2. Establish a heparin lock by continuing to inject heparin solution while withdrawing
the needle.
NOTE: The above step must be done to minimize refl ux of blood into the
catheter.
D. Site Closure
1. Suture the portal to the underlying muscle fascia when possible or to subcutaneous
tissue using permanent sutures in all available suture holes to prevent the
portal from changing position aft er placement.
2. Close the portal pocket, ensuring that the portal does not lie directly under the
incision.
E. Postoperative Care
Observe the patient for any potential complications immedi ately fol lowing system
implantation.
VI. INSTRUCTIONS FOR
SYSTEM ACCESS
A. Determining System Integrity
WARNING: Do not initiate injection or infusion therapy until system integrity is confi rmed.
If integrity is not confi rmed, damage to the system may exist, which may include but is
not limited to, catheter rupture or fragmentation with possible em bolization, or drug
extravasation.
NOTE: This procedure requires aseptic technique and sterile equipment.
Before starting an injection or infusion therapy it is essential to confi rm system
integrity and assure that no system damage exists by completing steps 1 through 10
below.
If system integrity is in doubt as a result of any of the following steps, further
verifi cation will be required. Th is may consist of radiography (fl uoroscopy, x-ray).
If radiography is used, the patient should be placed in an upright, arms-at-sides
position. 1,2,5,7,8
1. Inquire and/or observe whether the patient has experienced any symptoms that
might warn of catheter fragmentation and/or catheter embolization since the
system was last accessed; for example, episodes of shortness of breath, chest pain,
or palpitations. If any of these symptoms are reported, an x-ray is recommended
to determine if there are problems with the catheter.
2. Examine and palpate the portal pocket and catheter tract for erythema, swelling,
tenderness, or infection which might indicate system leakage. If system leakage is
suspected, an x-ray is recommended to determine if there are problems with the
system.
3. Set up the sterile fi eld and supplies.
4. Prepare the site for the injection or infusion.
5. Anesthetize the site for needle puncture, if desired.
6. Using a 10-ml or larger syringe, prime the non-coring PORT-A-CATH® access
needle and any attached extension set to remove all air from the fl uid path. Do
not use standard hypodermic needles, as these will damage the septum and may
cause leakage.
7. Locate the portal by palpation and immobilize it using thumb and fi ngers of the
nondominant hand.
8. Insert the non-coring needle through the skin and portal septum at a 90° angle to
the septum. To avoid injection into the subcutaneous tissue, slowly advance the
needle until it touches the bottom of the portal chamber
(Figure 22).
WARNING: Do not tilt or rock the needle once the septum is punctured as this may
cause fl uid leakage or damage to the septum.
9. Aspirate for blood return. Diffi culty in withdrawing blood may indicate catheter
blockage or improper needle position.
WARNING: Do not exceed a pressure of 40 psi [2.76 bar; 275 kPa] when fl ushing fl uid
through the system. Excessive pressure may damage the system and can easily be
generated with power injectors or with all syringes. The smaller the syringe, the higher
the pressure that can be generated with the same applied force. Do not continue
attempts to fl ush the system if extreme resistance is encountered. Damage due to
excessive pressure may include but is not limited to, catheter rupture or fragmentation
with possible em bolization, or drug extravasation.