Bard Power-Trialysis, Инструкция по эксплуатации, Страница: 3 / 10

Indications For Use
The Power-Trialysis
™
Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media,
and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis,
hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.
The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Contraindications
The catheter is intended for short-term vascular access only and is not to be used for any purpose other than indicated in these instructions.
The device is also contraindicated :
• When the presence of device related infection, bacteremia, or septicemia is known or suspected.
• When the patient’s body size is insufficient to accommodate the size of the implanted device.
• When the patient is known or is suspected to be allergic to materials contained in the device.
• If the prospective insertion site has been previously irradiated.
• If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures.
• If local tissue factors may prevent proper device stabilization and/or access.
Warnings
• SUBCLAVIAN ONLY. Percutaneous insertion of the catheter must be
made into the axillary-subclavian vein at the junction of the outer and
mid-third of the clavicle lateral to the thoracic outlet. The catheter must
not be inserted into the subclavian vein medially, because such placement
can lead to compression of the catheter between the first rib and clavicle
and can lead to damage or fracture and embolization of the catheter.
1
Fluoroscopic or radiographic confirmation of catheter tip placement can
be helpful in demonstrating that the catheter is not being pinched by the
first rib and clavicle.
2
SIGNS OF PINCH-OFF
Clinical:
• Difficulty with blood withdrawal.
• Resistance to infusion of fluids.
• Patient position changes required for
infusion of fluids or blood withdrawal.
Radiologic: (see table)
• Grade 1 or 2 distortion on chest X-ray.
Pinch-off should be evaluated for degree
of severity prior to explantation. Patients
indicating any degree of catheter
distortion at the clavicle/first rib area
should be followed diligently. There
are grades of Pinch-off that should be
recognized with appropriate chest x-ray
as follows:
2
• The catheter must not be left in the femoral vein longer than three days. It is recommended that jugular and subclavian catheters be
replaced after four weeks.
• Alcohol or alcohol-containing antiseptics (such as chlorhexidine gluconate) may be used to clean the catheter/skin site; however, care
should be taken to avoid prolonged or excessive contact of the catheter with the solution(s). Solutions should be allowed to completely
dry before applying an occlusive dressing.
• Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure of this device and should not be used with polyurethane
catheters. Chlorhexidine patches or bacitracin zinc ointments are the preferred alternative.
• Do not resterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by re-use of
the catheter or accessories.
• Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or user infection, compromise the struc-
tural 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 polyurethane extension pieces. Polyurethane may develop cuts or tears if subjected to excessive
pulling or contact with rough edges. Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue and possible dis-
connection.
• Repeated over-tightening of bloodlines, syringes and caps will reduce connector life and may lead to connector failure.
• Enzymes in blood and heparin may cause temporary sticking of the extensions when clamped for extended periods of time. To release,
open clamp and slide away, gently rotating the tube between finger and thumb until the tubing separates.
First Rib
Subclavian Vein
Clavicle
Vertebra
Internal Jugular Vein
Superior Vena Cava
Sternum
Pinch-off Area
Infraclavicular Fossa
Axillary Vein
Grade 0
Grade 1
Grade 2
Grade 3
Radiologic Signs of Pinch-Off
No distortion
Distortion present
without luminal
narrowing
Distortion present
with luminal
narrowing
Catheter transection
or fracture
No action.
Chest x-ray should be taken to monitor
progression of pinch-off to grade 2
distortion. Shoulder positioning during
chest x-rays should be noted as it can
contribute to changes in distortion
grades.
Removal of the catheter should be
considered.
Prompt removal of the catheter .