Argon Medical Devices UltraStream Manual
Table of Contents
ENGLISH .............................................................................................................. 2
BULGARIAN ......................................................................................................... 9
CZECH .................................................................................................................17
DANISH................................................................................................................24
GERMAN..............................................................................................................31
GREEK.................................................................................................................39
SPANISH..............................................................................................................47
FINNISH ...............................................................................................................54
FRENCH...............................................................................................................61
CROATIAN...........................................................................................................69
HUNGARIAN........................................................................................................76
ITALIAN................................................................................................................83
LITUANIAN ..........................................................................................................90
LATVIAN ..............................................................................................................97
DUTCH ............................................................................................................... 104
NORWEGIAN..................................................................................................... 112
POLISH .............................................................................................................. 119
PORTUGUESE .................................................................................................. 127
RUSSIAN ........................................................................................................... 134
SLOVAK............................................................................................................. 142
SERBIAN ........................................................................................................... 149
SWEDISH........................................................................................................... 157
TURKISH............................................................................................................ 164
UKRAINIAN ....................................................................................................... 171
•Do not use sharp instruments near the extension tubes or catheter shaft. Do not use scissors to remove
the dressing, as this could possibly cut or damage the catheter. Do not suture through any part of the catheter.
If sutures are used to secure the catheter, be sure to use the suture wing. Catheter tubing can tear when subjected
to excessive force or rough edges.
•Avoid sharp or acute angles during implantation that may compromise catheter functionality.
•Fill (prime) the device with sterile, heparinized saline or normal saline solution to help avoid air embolism prior
to catheter insertion.
•Excessive force should not be used to flush obstructed lumen. Do not use a smaller syringe than 10 ml (cc).
•To prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.
•It is recommended that only luer lock (threaded) accessories and components are used with the UltraStream
Chronic Hemodialysis Catheter. Repeated over tightening of bloodlines, syringes, and caps will reduce connector
life and could lead to potential connector failure. Inspect the catheter frequently for nicks, scrapes, cuts, etc. which
could impair its performance.
•Clamping the extension tubes repeatedly in the same spot could weaken the tubing. Change the position of the
clamp regularly to prolong the life of the tubing. Avoid clamping near the adapter and hub of the catheter. Do not
clamp the shaft of the catheter. Use only the line extension clamps which have been provided with the catheter.
Examine tubing for damage at the end of each treatment.
Possible Complications
•Air Embolism
•Perforation of Vessel
•Hemorrhage
•Endocarditis
•Bacteremia
•Pneumothorax
•Hemothorax
•Exit Site Infection
•Bleeding
•Subcutaneous Hematoma
•Inflammation
•Exit Site Necrosis
•Brachial Plexus Injury
•Thoracic Duct Injury
•Laceration of Vessel
•Fibrin Sheath Formation
•Cardiac Arrhythmia
•Tunnel Disease
•Lumen/Vessel Thrombosis
•Hematoma
•Cardiac Tamponade
•Vascular Thrombosis
•Death
Insertion Sites
The UltraStream Chronic Hemodialysis Catheter may be inserted percutaneously and is ideally placed in the jugular
vein. Although this catheter may be placed in the subclavian vein, the internal jugular is the preferred site (National
Kidney Foundation Dialysis Outcomes Quality Initiative (NKF/KDOQI) Guideline 5, NKFKDOQI Update 2006).
Caution
•Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation.
•Long time use of the subclavian vein may be associated with subclavian vein stenosis.
Directions for Catheter Insertion (Standard Kit)
The UltraStream Chronic Hemodialysis Catheter should be inserted, manipulated, and removed only by a qualified,
licensed, physician or other health care practitioner authorized by and under the direction of such physician. Medical
techniques and procedures described in these instructions do not represent all medically accepted protocols, nor are
they intended as a substitute for a physician’s experience and judgment in treating any specific patient.
Caution: Strict aseptic technique must be used during the insertion, maintenance, and removal procedures.
1) Select the appropriate catheter length to achieve proper tip positioning. Proper catheter length selection is
important and will be determined by patient anatomy.
NOTE: For ease in dressing the exit site and for patient comfort, locate the subcutaneous tunnel exit site
below the clavicle. Tunnels with a wide gentle arc lessen the risk of kinking. The tunnel should be short
enough to keep the Y-hub of the catheter from entering the exit site, yet long enough to keep the cuff at
least 2cm from the skin opening.
2) Administer sufficient local anesthetic to completely anesthetize the insertion area and the tunnel site.
3) Gain percutaneous access to the selected vein using a micro-puncture or similar introducer system.
4) After gaining access, exchange the .018 in. introducer guidewire for an appropriate length .035/.038 in.
guidewire. Be sure to confirm proper guidewire position using fluoroscopic visualization.
CAUTION: The length of wire inserted is determined by the size of the patient. Monitor patient for signs of
arrhythmia throughout this procedure. The patient should be placed on a cardiac monitor during this
procedure.Cardiac arrhythmias may result if the guidewire is allowed to pass into the right atrium or ventricle.
The guidewire should be held securely during this procedure.
CAUTION: When an introducer needle is used, do not withdraw guidewire against needle bevel to avoid
possible severing of guidewire.
5) Flush the dilator with sterile, normal or heparinized saline solution and insert over the .035/.038 in. guidewire
located at the venotomy site. Dilator may be left in place.
6) Make a small incision at the predetermined exit site on the chest wall wide enough to accommodate the
polyester catheter cuff, approximately 1 cm long.
7) Prepare the UltraStream and flexible stiffener for insertion by gently wiping the exposed distal portion with
sterile, normal or heparinized saline solution and irrigating all lumens using 10 ml (cc) syringes filled with
normal or heparinized saline solution.
3
8) Clamp only the red (arterial) extension tubing using the color coded in-line clamp provided and remove
syringe. Attach stainless steel tunneler to the UltraStream’s venous tip. Avoid damage to the catheter tip
during placement. Slide the protective sheath onto the UltraStream to fully cover the catheter tip. Advance
the flexible stiffener into the venous luer until the stiffener tip gently contacts the stainless steel tunneler.
NOTE: Stiffener luer and UltraStream venous luer will not be connected during catheter tunneling.
9) Using the tapered tip of the tunneler to perform blunt dissection, create a subcutaneous tunnel starting at
the exit site and ending by exiting at the site of the venotomy/dilator.
CAUTION: Do not tunnel through the muscle. The tunnel should be made with care to prevent damaging
surrounding vessels and nerves.
10) Pull the UltraStream through the subcutaneous tract. Position proximal catheter allowing for standard
polyester cuff placement (approx. 2cm within the tract).
11) Gently remove the tunneler from the UltraStream. Advance the stiffener until the luer connection with the
UltraStream can be tightened and secured.
12) Maintaining pressure over the vascular access site to prevent bleeding, remove the dilator leaving the
0.035/0.038in. guidewire in place. Backload the guidewire into the UltraStream distal stiffener lumen.
13) Advance the UltraStream and flexible stiffener over the proximal portion of the 0.035/0.038in. guidewire
through the subcutaneous tissue and into the vessel until proper catheter tip positioning is confirmed with
fluoroscopic visualization. If resistance is encountered, further blunt dissection may facilitate insertion.
It is recommended that the arterial lumen, indicated by the red luer-lock connector, be oriented cephalad
when the catheter is placed on the patient’s right side. If the catheter is placed on the patient’s left side,
then the venous lumen, indicated by the blue luer-lock connector, be placed cephalad. This would ensure
that the arterial lumens are positioned in the right atrium towards the mediastinum per the 2006 NKF/KDOQI
Guidelines.
CAUTION: Do not advance the catheter and stiffener past the tip of the guidewire as this could cause vessel
perforation, and or bleeding.
14) When the UltraStream and the stiffener are properly located within the vessel using fluoroscopic visualization,
unlock and gently remove the stiffener and guidewire from the catheter.
15) Attach a 20 ml (cc) syringe to one extension and open clamp. Blood should aspirate easily. Once adequate
blood flow has been established, flush the lumen(s) and then re-clamp the extension tube and remove syringe.
Repeat this step for the other catheter extension.
CAUTION: Avoid air embolism by keeping the catheter tubing clamped at all times when not in use and by
filling the catheter with sterile, normal or heparinized saline solution prior to use. With each change in tubing
connections, purge air from the catheter and all connecting tubing and caps.
CAUTION: Clamp only the extension tubes with the in-line clamps provided with the UltraStream catheter.
Do not use forceps and do not clamp the distal portion of the catheter.
NOTE: If excessive resistance to blood aspiration exists, the catheter may need to be rotated, flushed or
repositioned to sustain adequate blood flow. A pre-existing fibrin sheath may also be present.
16) Fill a 20 ml (cc) syringe with sterile, normal or heparanized saline solution, attach to one of the catheter
extensions, open clamp, and irrigate the lumen. Once the lumen has been irrigated, re-clamp the extension
tube and remove the syringe. Repeat this step for the other catheter extension.
17) Attach both injection caps to the catheter luers post placement.
18) If the catheter is not used immediately for treatment, follow standard protocol for establishing a heparin lock
in each catheter. Refer to the Heparinization section for additional notes.
19) Immediately after insertion, confirm proper placement of the tip of the catheter with fluoroscopic visualization.
The catheter tip should be positioned at the level of the caval atrial junction or into the right atrium to ensure
optimal blood flow (as recommended in current NKF/KDOQI Guidelines). ALWAYS ATTACH BOTH INJECTION
CAPS TO CATHETER LUERS POST PLACEMENT.
CAUTION: Failure to verify catheter placement may result in serious trauma or fatal complications.
20) Suture the tunnel exit site and vein insertion site if necessary. Suture the catheter to the skin using the fixed
suture wings. Do not suture the catheter tubing.
21) Apply provided dressings per hospital policy.
NOTE: It is particularly important to immobilize cuffed catheters for 7 days to prevent cuff dislodgment.
NOTE: Before dialysis begins, all connections to the extracorporeal circuit should be checked carefully.
During all dialysis procedures, frequent visual inspection should be conducted to detect leaks and prevent
blood loss or entry of air into the extracorporeal circuit.
Directions for Catheter Insertion (Standard Kit with Peel Away Sheath)
The 15.5F UltraStream Chronic Dialysis Catheter should be inserted, manipulated, and removed only by a qualified,
licensed physician or other healthcare practitioner authorized by and under the direction of such physician. Medical
techniques and procedures described in these instructions do not represent all medically accepted protocols, nor are
4
they intended as a substitute for a physician’s experience and judgment in treating any specific patient.
Caution: Strict aseptic technique must be used during the insertion, maintenance, and removal procedures.
1) Select the appropriate catheter length to achieve proper tip positioning. Proper catheter length selection is
important and will be determined by patient anatomy.
NOTE: For ease in dressing the exit site and for patient comfort, locate subcutaneous tunnel exit site below
the clavicle. Tunnels with a wide gentle arc lessen the risk of kinking. The tunnel should be short enough to
keep the Y-hub of the catheter from entering the exit site, yet long enough to keep the cuff at least 2cm from
skin opening.
2) Administer sufficient local anesthetic to completely anesthetize insertion area and tunnel site.
3) Gain percutaneous access to the selected vein by inserting introducer needle placing thumb over the end to
prevent blood loss and air embolism.
4) Insert 0.038in. cm marked guidewire through needle and into the vein. Guidewire should be inserted under
Fluoroscopy, note the depth markings on guidewire when desired tip position is reached.
CAUTION: Length of wire inserted is determined by the size of the patient. Monitor patient for signs of
arrhythmia throughout this procedure. Patient should be placed on a cardiac monitor during this procedure.
Cardiac arrhythmias may result if the guidewire is allowed to pass into the right atrium or ventricle. Guidewire
should be held securely during this procedure.
CAUTION: When introducer needle is used, do not withdraw guidewire against needle bevel to avoid
possible severing of guidewire.
5) Remove introducer needle leaving guidewire in the vessel.
6) Flush the tissue dilator with sterile, normal or heparinized saline solution and insert over the 0.038in.
guidewire located at the venotomy site.
7) Prepare the peel away introducer by removing the dilator, sliding the valve and inserting the dilator through
the valve. Lock in place by using the rotating collar. Flush peel away introducer with sterile, normal or
heparinized saline.
8) Remove the tissue dilator leaving guidewire in vessel.
9) Advance the peel away introducer over the guidewire and into the vein.
10) Remove the peel away dilator and the guidewire by unlocking the rotating collar and gently withdrawing
dilator from the sheath.
11) Make a small incision at the predetermined exit site on the chest wall wide enough to accommodate
polyester catheter cuff, approximately 1 cm long.
12) Prepare the UltraStream for insertion by gently wiping the exposed distal portion with sterile, normal or
heparinized saline solution and irrigating all lumens using 10ml (cc) syringes filled with normal or
heparinized saline solution.
13) Clamp only the red (arterial) extension tubing using color coded in-line clamp provided and remove syringe.
Attach tri-ball tunneler to venous tip. Avoid damage to catheter tip during placement. Slide protective sheath
onto UltraStream to fully cover the catheter tip.
14) Using tapered tip of the tunneler to perform blunt dissection, create a subcutaneous tunnel starting at the
exit site and ending by exiting at the site of the venotomy/dilator.
CAUTION: Do not tunnel through the muscle. The tunnel should be made with care to prevent damaging
surrounding vessels and nerves.
NOTE: The flexible stiffener may be used as needed.
15) Pull catheter through subcutaneous tract. Position proximal catheter allowing for standard polyester cuff
placement (Approx. 2cm within tract).
16) Gently remove tunneler from catheter.
17) Advance catheter through the valved peel away sheath. To prevent kinking the catheter, it may be
necessary to advance in small steps by grasping the catheter close to the sheath. It is recommended
that the arterial lumen, indicated by the red luer-lock connector, be oriented cephalad when the catheter
is placed on the patient’s right side. If the catheter is placed on the patient’s left side, then the venous
lumen, indicated by the blue luer-lock connector, be placed cephalad. This would ensure that the arterial
lumens are positioned in the right atrium towards the mediastinum per the 2006 NKF/KDOQI Guidelines.
18) After the catheter is in position, crack the sheath handle in half.
19) Peel the non-valved side of the handle partially away from the catheter.
20) Near the valve, hold the catheter firmly in position and pull the valve off the catheter.
NOTE: It is normal to experience some resistance while pulling the catheter through the slit on the valve.
5
21) Remove the peel-away sheath from the patient.
22) Attach a 20 ml (cc) syringe to one extension and open clamp. Blood should aspirate easily. Once adequate
blood flow has been established, flush the lumen(s) and then re-clamp extension tube and remove syringe.
Repeat this step for the other catheter extension.
CAUTION: Avoid air embolism by keeping the catheter tubing clamped at all times when not in use and by
filling the catheter with sterile, normal or heparinized saline solution prior to use. With each change in tubing
connections, purge air from the catheter and all connecting tubing and caps.
CAUTION: Clamp only the extension tubes with in-line clamps provided with the catheter. Do not use forceps
and do not clamp the distal portion of the catheter.
NOTE: If excessive resistance to blood aspiration exists, the catheter may need to be rotated, flushed or
repositioned to sustain adequate blood flow. A pre-existing fibrin sheath may also be present.
23) Fill a 20 ml syringe with sterile, normal or heparinized saline solution, attach to one of the catheter extensions,
open clamp, and irrigate the lumen. Once the lumen has been irrigated, reclamp the extension tube and
remove the syringe. Repeat this step for the other catheter extension.
24) Attach both injection caps to catheter luers post placement.
25) If the catheter is not used immediately for treatment, follow standard protocol for establishing a heparin lock
in each catheter. Refer to Heparinization section for additional notes.
26) Immediately after insertion, confirm proper placement of the tip of the catheter with fluoroscopic visualization.
The catheter tip should be positioned at the level of the caval atrial junction or into the right atrium to ensure
optimal blood flow (as recommended in current NKF/KDOQI Guidelines). ALWAYS ATTACH BOTH INJECTION
CAPS TO CATHETER LUERS POST PLACEMENT.
CAUTION: Failure to verify catheter placement may result in serious trauma or fatal complications.
27) Suture the tunnel exit site and vein insertion site if necessary. Suture the catheter to the skin using fixed suture
wings. Do not suture the catheter tubing.
28) Apply provided dressings per hospital policy.
NOTE: It is particularly important to immobilize cuffed catheters for 7 days to prevent cuff dislodgment. Assess
catheter fixation before removing sutures.
NOTE: Before dialysis begins, all connections to the extracorporeal circuit should be checked carefully. During
all dialysis procedures, frequent visual inspection should be conducted to detect leaks and prevent blood loss
or entry of air into the extracorporeal circuit.
Directions for Catheter Exchange
The 15.5Fr UltraStream Chronic Dialysis Catheter should be inserted, manipulated, and removed only by a qualified,
licensed physician or other health care practitioner authorized by and under the direction of such physician. Medical
techniques and procedures described in these instructions do not represent all medically accepted protocols, nor are
they intended as a substitute for a physician’s experience and judgment in treating any specific patient.
CAUTION: Review hospital or departmental protocol, warnings, cautions, guidelines, potential complications
and their treatment, prior to catheter removal.
CAUTION: Strict aseptic technique must be used during the insertion, maintenance, and removal procedures.
NOTE: Review existing catheter manufacturer’s instructions for removal and verify if exchange procedure is
appropriate.
1) Remove existing catheter by cutting sutures from suture wing, if required.
2) Free the cuff from the tissue using blunt or sharp dissection as needed (located at exit site).
3) Unlock the venous clamp and advance an 0.035/0.038in. guidewire down the venous lumen into the
designated position, unless contraindicated. Confirm proper guidewire placement under fluoroscopy per
NKF/KDOQI guidelines.
Note: Guidewire must be the proper length so the guidewire will extend distal to the tip of the catheter at
all times during the placement.
4) While holding the 0.035/0.038in. guidewire in place, gently pull the catheter out over-the-wire.
Caution: When removing the catheter, DO NOT use a sharp, jerking motion or undue force; this may tear
the catheter.
5) After removing the catheter, apply manual pressure to the puncture site to control bleeding.
6) Remove protective shipping sleeve from the replacement catheter.
7) Prepare the UltraStream catheter and flexible stiffener for insertion by gently wiping the exposed distal
6
portion with sterile, normal or heparinized saline solution and irrigating all lumens using 10 ml (cc) syringes
filled with normal or heparinized saline solution. Remove the flexible stiffener prior to irrigation. Lock arterial
clamp after irrigating.
8) Fully advance and secure the flexible stiffener into the UltraStream venous lumen.
Caution: Do not lock the blue venous clamp over the stiffener. The red arterial clamp should be locked prior
to advancing over-the-wire.
9) Insert the 0.035/0.038in. guidewire into the distal end of the flexible stiffener, until guidewire exits out of the
blue venous luer.
10) Advance the catheter over-the-wire thru the existing tunnel until proper catheter tip positioning is confirmed
with fluoroscopic visualization, per NKF/KDOQI guidelines. It is recommended that the arterial lumen,
indicated by the red luer-lock connector, be oriented cephalad when the catheter is placed on the patient’s
right side. If the catheter is placed on the patient’s left side, then the venous lumen, indicated by the blue
luer-lock connector, be placed cephalad. This would ensure that the arterial lumens are positioned in the
right atrium towards the mediastinum per the 2006 NKF/KDOQI Guidelines.
Caution: Do not advance the catheter and stiffener past the tip of the guidewire as this could cause vessel
perforation, and or bleeding.
Note: If resistance is felt, a 16F dilator may be used to dilate tunnel.
Note: Polyester cuff should be positioned approximately 2 cm from exit site.
11) Once position is confirmed, slowly remove 0.035/0.038in. guidewire, flexible stiffener, and attention tag
attached to the venous clamp.
12) Attach a 20 ml (cc) syringe to one extension and open clamp. Blood should aspirate easily. Once adequate
blood flow has been established, flush the lumen(s) and then re-clamp the extension tube and remove syringe.
Repeat this step for the other catheter extension.
CAUTION: Avoid air embolism by keeping the catheter tubing clamped at all times when not in use and by
filling the catheter with sterile, normal or heparinized saline solution prior to use. With each change in tubing
connections, purge air from the catheter and all connecting tubing and caps.
CAUTION: Clamp only the extension tubes with the in-line clamps provided with the UltraStream catheter.
Do not use forceps and do not clamp the distal portion of the catheter.
NOTE: If excessive resistance to blood aspiration exists, the catheter may need to be rotated, flushed or
repositioned to sustain adequate blood flow. A pre-existing fibrin sheath may also be present.
13) Fill a 20 ml (cc) syringe with sterile, normal or heparanized saline solution, attach to one of the catheter
extensions, open clamp, and irrigate the lumen. Once the lumen has been irrigated, re-clamp the extension
tube and remove the syringe. Repeat this step for the other catheter extension.
14) Reference hospital protocol for heparin lock concentration and administer according to venous/arterial priming
volumes.
15) Attach both injection caps to catheter luers post placement.
16) Close the incision with a suture as needed, then apply an adhesive wound dressing.
17) Suture wings to patients skin.
Heparinization
To maintain catheter function between treatments, a heparin lock must be created in each lumen of the catheter. Follow
standard institutional protocol when creating the heparin lock.
•When creating the heparin lock, be sure to maintain positive pressure on the syringe until after the catheter is
clamped.
•The internal volume of each lumen is marked on the tags. Inject enough heparin solution to fill all lumens.
•Once the lumens have been heparinized, keep both extensions clamped when not attached to the bloodlines
or a syringe.
•The heparin solution must be removed by aspirating 3 ml (cc) out of the lumen immediately prior to use to
prevent systemic heparinization of the patient.
Priming Volume:
Tip To Hub Length Arterial Volume Venous Volume
24cm 2.6cc 1.6cc
28cm 2.8cc 1.8cc
32cm 3.0cc 2.0cc
36cm 3.2cc 2.2cc
40cm 3.6cc 2.4cc
55cm 4.6cc 3.0cc
7
Site Care
CAUTION: Use caution when cleaning the catheter exit site. Povidone iodine, dilute aqueous sodium hypochlorite
solution, chlorhexidine gluconate 4%, or chlorhexidine gluconate 2% solution are the recommended antiseptic to
be used with this catheter.
Clean the skin around the catheter. Cover the exit site with two occlusive dressings applied sandwich style around
the catheter. Leave the extensions, clamps, adapters and caps exposed for access by the staff. Wound dressings
must be kept dry. Patient must not swim, shower, or soak dressing while bathing. If adhesion of dressing is
compromised by profuse perspiration or accidental wetting, the dressing must be changed by the medical or nursing
staff under sterile conditions.
Management of Lumen Obstruction
Lumen obstruction is usually evident by failure to aspirate blood from the lumen, inadequate blood flow and/or high
resistance pressures during hemodialysis. The causes may include inadequate catheter tip position, catheter kink
and clot. One of the following may resolve the obstruction:
Verify that the clamps are open when trying to aspirate or flush the catheter lumen.
Reposition the patient.
Have the patient cough.
Provided there is no resistance, flush the catheter vigorously with sterile normal saline.
Never forcibly flush an obstructed lumen. If either lumen develops a thrombus, first attempt to aspirate the clot with
a syringe. If aspiration fails, the physician may consider using a thrombus dissolving solution (i.e. TPA) to dissolve
the clot.
Removal
Free the cuff from the tissue prior to removal. After removing the catheter, apply manual pressure to the puncture
site to control bleeding. Close the incision with a suture as needed. Then apply an adhesive wound dressing.
CAUTION: When removing the catheter, DO NOT use a sharp, jerking motion or undue force; this may tear the
catheter.
How Supplied
UltraStream Chronic Hemodialysis Catheters are sterilized by ethylene oxide gas. Contents sterile and non-pyrogenic
in unopened and undamaged package. Do not use catheter if package has been damaged or has been opened.
Storage
Store at room controlled temperature. Do not expose to organic solvents, ionizing radiation or ultraviolet light. Rotate
inventory so that catheters are used prior to the expiration date on the package label.
References
•Lebanc M, Bosc J, Paganini E, Canaud B. Central Venous Dialysis Catheter Dysfunction, Advances in
Renal Replacement Therapy, 1997; 4:377-389.
•Hirsch D, Bergan P, Jindal K. Polyurethane Catheters for Long-Term Hemodialysis Access.
Artificial Organs 1997; 21(5):349-354.
•Renner C RN, Polyurethane vs. Silicone PICC Catheters. JVAD Spring 1998; 16-21.
•National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF/KDOQI)
8
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%
•Lebanc M, Bosc J, Paganini E, Canaud B. Central Venous Dialysis Catheter Dysfunction, Advances in Renal
Replacement Therapy, 1997; 4:377-389.
•Hirsch D, Bergan P, Jindal K. Polyurethane Catheters for Long-Term Hemodialysis Access. Artificial Organs
1997; 21(5):349-354.
•Renner C RN, Polyurethane vs. Silicone PICC Catheters. JVAD Spring 1998; 16-21.
•National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF/KDOQI)
6'"$) *. 6,1 *
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16
CZECH
Varování:
Ureno pouze k jednomu pouití u jednoho pacienta. Nepouívejte opakovan, nerenovujte, neresterilizujte.
Opakované pouití, renovace nebo resterilizace me ohrozit strukturální integritu prostedku a/nebo vést k selhání
prostedku, které me následnzpsobit zranní, onemocnní nebo smrt pacienta. Opakované pouití, renovace nebo
resterilizace me zpsobit také riziko kontaminace prostedku nebo me zpsobit infekci i kíovou infekci vetn
penosu infekních onemocnní z jednoho pacienta na druhého, ale i dalí potíe. Kontaminace prostedku me mít za
následek poranní, onemocnní nebo smrt pacienta. Podle federálních zákonUSA smí tento prostedek pouívat pouze
lékanebo osoba pod dohledem lékae.
Standardní souprava:
(1) Katetr UltraStream 15,5 French
(1) Flexibilní vztunprostedek
(1) Tunelátor
(1) Cévní dilatátor 16 French
(1) Bezpenostní skalpel
(1) Zavádcí jehla 18 G x 7 cm
(1) Bezpenostní pna
(2) Adhezivní krytí
(2) Injekní uzávry
Souprava Peel Away:
(1) Katetr UltraStream 15,5 French
(1) Zavad Peel Away s ventilem
(1) Tunelátor
(1) Cévní dilatátor 16 French
(1) Bezpenostní skalpel
(1) Zavádcí jehla 18 G x 7 cm
(1) Vodicí drát 0,038 palce
(0,97 mm) x 80 cm
(1) Bezpenostní pna
(2) Adhezivní krytí
(2) Injekní uzávry
(1) Flexibilní vztunprostedek
Náhradní souprava:
(1) Katetr UltraStream 15,5 French
(1) Flexibilní vztunprostedek
(2) Injekní uzávry
Popis prostedku
Permanentní hemodialyzaní katetr UltraStream je permanentní vícelumennrentgenokontrastní polyuretanovkatetr
opatenpolyesterovou manetou a dvma aretaními adaptéry Luer s vnitním závitem. Maneta podporuje
prorstání tkánza úelem upevnní katetru v subkutánním tunelu. Aretaní adaptéry Luer jsou barevnoznaeny,
take lze rozliit arteriální a venózní lumeny. ervenadaptér Luer oznauje arteriální odtok z tla pacienta a modr
adaptér Luer oznauje ilní návrat do tla pacienta. Kadá svorka má navíc títek, kterje oznaen odpovídajícím
plnicím objemem.
Níe je znázornno srovnání profilu prtoku a tlaku permanentního hemodialyzaního katetru UltraStream.
Indikace
Permanentní hemodialyzaní katetr UltraStream je uren k pouití pi trvalé hemodialze a aferéze.
Kontraindikace
Pouití prostedku je kontraindikováno v následujících pípadech:
•Vskyt infekcí souvisejících s jinm prostedkem, podezení na bakterémii nebo septikémii i potvrzená
bakterémie i septikémie.
•Stávající závané chronické obstrukní onemocnní plic.
•Postradiace místa plánovaného zavedení prostedku.
•Epizody ilní trombózy v anamnéze nebo pokud v minulosti dolo k cévním chirurgickm vkonm v oblasti
plánovaného umístní prostedku.
•Lokální faktory tkánbránící správné stabilizaci a/nebo pístupu prostedku.
Varování
•Vzhledem k riziku expozice HIV (virus lidské imunodeficience) i jinm patogenm penáenm krví je vhodné,
aby zdravotnickpersonál pi péi o vechny pacienty rutinndodroval obecná ochranná opatení vhodná pi
práci s krví a s tlními tekutinami. Pi vekeré manipulaci s prostedkem se musí písndodrovat sterilní postupy.
•Zabrate vzduchové embolii – zasvorkujte katetr vdy, kdy není pipojen ke stíkakám nebo ke krevním linkám.
•Na ádnou ást hadiek katetru neaplikujte aceton ani roztoky jodu na bázi alkoholu (tinktury). Takové látky
mohou svm psobením pokodit katetr. Místo vstupu se doporuuje oetovat betadinem na vodní bázi.
•Vodicí drát musí bt bhem zavádní katetru vdy distálnvi hrotu vztuného prostedku.
•Katetr se musí posouvat pouze po vodicím drátu.
Veobecná upozornní
Prtok (ml/min)
Tlak (mmHg)
17
•Pokud katetr nebo komponenty vykazují jakékoli známky pokození (nap. jsou-li ohnuté, promáknuté, poezané
atd.), nepouívejte je.
•V blízkosti prodluovacích hadiek nebo tubusu katetru nepouívejte ostré nástroje. K odstranní krycího materiálu
nepouívejte nky, nebotak vzniká riziko pestiení nebo pokození katetru. ádnou ást katetru neproívejte
stehy. Pokud se k zajitní katetru pouívají stehy, musíte pouít kidélko pro piití. Pokud na hadiky katetru
psobí nadmrná síla nebo pokud se hadiky dotkají drsnch okraj, mohou se roztrhnout.
•Bhem implantace katetr neohbejte pod ostrmi úhly, protoe by se tím mohla pokodit jeho funknost.
•Ped zavedením katetru prostedek naplte sterilním heparinizovanm fyziologickm roztokem nebo normálním
fyziologickmroztokem za úelem potlaení rizika vzduchové embolie.
•Propláchnutí ucpaného lumen se nesmí provádt nadmrnou silou. Nepouívejte stíkaku mení ne10 ml.
•Kvli prevenci nehod zkontrolujte ped zahájením oetení a mezi jednotlivmi oeteními bezpenost vech
uzávra spojek krevních linek.
•S permanentním hemodialyzaním katetrem UltraStream se doporuuje pouívat pouze písluenství a
komponenty Luer lock opatené závitem. Pi opakovaném utahování krevních linek, stíkaek a uzávrpíli
velkou silou se zkracuje ivotnost spojky a me dojít i k jejímu selhání. asto kontrolujte, zda katetr není
pokrában, oden, naíznutatd. a zda tak není zhorena jeho funknost.
•Opakovanm svorkováním prodluovací hadiky na stejném místse hadika me zeslabit. Za úelem
prodlouení ivotnosti hadiky pravidelnmte polohu svorky. Svorku neumísujte v blízkosti adaptéru a
ústí katetru. Nesvorkujte tubus katetru. Pouívejte vhradnsvorky prodluovacích hadiek, které byly dodány
s katetrem. Na konci kadého oetení zkontrolujte, zda nejsou hadiky pokozené.
Moné komplikace
•vzduchová embolie;
•perforace cévy;
•hemorragie;
•endokarditida;
•bakterémie;
•pneumotorax;
•hemotorax;
•infekce místa vstupu;
•krvácení;
•subkutánní hematom;
•zánty;
•nekróza místa vstupu;
•poranní brachiálního plexu;
•poranní hrudního mízovodu;
•lacerace cévy;
•vytvoení fibrinové zátky;
•srdení arytmie;
•chorobnstav tunelu;
•trombóza lumen/cévy;
•hematom;
•srdení tamponáda;
•vaskulární trombóza;
•smrt.
Místa zavedení
Permanentní hemodialyzaní katetr UltraStream lze zavést perkutánna v ideálním pípadumístit do jugulární íly.
Pestoe lze tento katetr umístit i do podklíkové íly, je preferováno umístní do vnitní jugulární íly (podle pokynu 5
iniciativy Národní nadace pro onemocnní ledvin [National Kidney Foundation Dialysis Outcomes Quality Initiative –
NKF/KDOQI], aktualizace NKFKDOQI 2006).
Upozornní
•U pacient, u nichje nutná podpora ventilace, je zvené riziko pneumotoraxu pi kanylaci podklíkové íly.
•Dlouhodobé pouívání podklíkové íly me bt spojeno se stenózou podklíkové íly.
Pokyny pro zavedení katetru (standardní souprava)
Zavádní a odstranní permanentního hemodialyzaního katetru UltraStream a manipulaci s ním má provádt pouze
kvalifikovanlékanebo jinoprávnnkvalifikovanzdravotnickpracovník pod dohledem takového lékae. Lékaské
techniky a procedury popsané v tchto pokynech nepedstavují vechny lékasky akceptovatelné protokoly ani nejsou
ureny jako náhrada za lékaskou zkuenost a odborné posouzení pi lébkonkrétního pacienta.
Upozornní: Bhem pístupu, provádní údrby a vyjímání písndodrujte aseptickou techniku.
1) Vyberte vhodnou délku katetru, abyste dosáhli správného umístní hrotu. Správnvbr délky katetru je
dleita bude záviset na anatomii pacienta.
POZNÁMKA: Kvli usnadnní aplikace krytí na místo vstupu a kvli komfortu pacienta umístte vstup tunelu
pod klíní kost. Tunely vedené v irokém mírném oblouku sniují riziko zauzlování katetru. Tunel musí bt
dostatenkrátk, aby ústí katetru ve tvaru Y nemohlo vstoupit do místa vstupu; zárovemusí bt tunel
dostatendlouh, aby udrel manetu nejmén2 cm od otvoru v pokoce.
2) Aplikujte dostatené mnoství lokálního anestetika, aby se zcela anestetizovala oblast zavedení a tunel.
3) Pomocí mikropunkního zavádcího systému nebo ekvivalentu vytvote perkutánní pístup do zvolené íly.
4) Po vytvoení pístupu nahrate zavádcí vodicí drát o velikosti 0,018 palce (0,46 mm) za vodicí drát o velikosti
0,035 palce (0,89 mm) nebo 0,038 palce (0,97 mm) vhodné délky. Správnou polohu vodicího drátu musíte
potvrdit skiaskopicky.
UPOZORNNÍ: Délka zavedeného vodicího drátu závisí na velikosti pacienta. Bhem tohoto postupu sledujte,
zda pacient nevykazuje známky arytmie. Bhem tohoto postupu se pacient musí napojit na monitor srdení
innosti. Pokud necháte vodicí drát proniknout do pravé sínnebo komory, mohou se vyskytnout srdení arytmie.
Bhem tohoto postupu se musí vodicí drát pevndret.
UPOZORNNÍ: Pouíváte-li zavádcí jehlu, nevytahujte vodicí drát proti zkosení jehly, aby nedolo k peíznutí
vodicího drátu.
5) Propláchnte dilatátor sterilním normálním nebo heparinizovanm fyziologickm roztokem a zavete jej po
vodicím drátu o velikosti 0,035 palce (0,89 mm) nebo 0,038 palce (0,97 mm), kterse nachází v míst
venotomie. Dilatátor se me ponechat na míst.
18
6) Vytvote malou incizi v hrudní stnna pedem ureném místvstupu; incize musí bt dostateniroká,
aby se pizpsobila polyesterové manetkatetru a dlouhá cca 1 cm.
7) Pipravte k zavedení katetr UltraStream a flexibilní vztunprostedek: jemnotete exponovanou distální
ást sterilním normálním nebo heparinizovanm fyziologickm roztokem a propláchnte vechny lumeny
pomocí 10ml stíkaek naplnnch normálním nebo heparinizovanm fyziologickm roztokem.
8) Pomocí dodané barevnoznaené vazené svorky zasvorkujte pouze ervenou (arteriální) prodluovací
hadiku a odstrate stíkaku. K ilnímu hrotu katetru UltraStream pipojte tunelátor z nerez oceli. Zabrate
pokození hrotu katetru bhem umísování. Na katetr UltraStream nasute ochrannsheath tak, aby zcela
pekryl hrot katetru. Posunujte flexibilní vztunprostedek do ilní spojky Luer, ase hrot vztuného
prostedku jemndotkne tunelátoru z nerez oceli.
POZNÁMKA: Bhem tunelování pomocí katetru nebude ilní spojka Luer na vztuném prostedku propojena
se spojkou Luer na katetru UltraStream.
9) Pomocí zúeného hrotu tunelátoru provete tupou disekci a vytvote subkutánní tunel s poátkem v míst
vstupu a koncem v místvenotomie/dilatátoru.
UPOZORNNÍ: Tunel nesmí procházet skrz sval. Tunel je nutno vytváet etrn, aby se zabránilo pokození
okolních cév a nerv.
10) Protáhnte katetr UltraStream subkutánním traktem. Proximální ást katetru dejte do polohy umoující
umístní standardní polyesterové manety (cca 2 cm uvnittraktu).
11) Opatrnvyjmte tunelátor z katetru UltraStream. Posute vztunprostedek, aby bylo moné utáhnout a
zajistit spojku Luer s katetrem UltraStream.
12) Kvli prevenci krvácení udrujte tlak nad místem pístupu do cévy. Vyjmte dilatátor; vodicí drát o velikosti
0,035 palce (0,89 mm)/0,038 palce (0,97 mm) ponechte na míst. Technikou „backload“ zavete vodicí drát
do distálního lumen vztuného prostedku katetru UltraStream.
13) Posunujte katetr UltraStream a flexibilní vztunprostedek po proximální ásti vodicího drátu o velikosti
0,035 palce (0,89 mm) nebo 0,038 palce (0,97 mm) skrz subkutánní tkádo cévy, ado okamiku, kdy
skiaskopicky potvrdíte správné umístní hrotu katetru. Narazíte-li na odpor, mete zavádní usnadnit dalí
tupou disekcí. Arteriální lumen oznaenervenou spojkou Luer lock doporuujeme orientovat smrem k hlav
(kdyje katetr umístn na pravé stranpacienta). Pokud se katetr umístí na levou stranu pacienta, musí se
ilní lumen oznaenmodrou spojkou Luer lock umístit tak, aby smoval k hlav. Tím se zajistí, aby arteriální
lumeny umístné v pravé síni smovaly k mediastinu (podle pokyn2006 NKF/KDOQI).
UPOZORNNÍ: Katetr a vztunprostedek neposouvejte za hrot vodicího drátu, neboby mohlo dojít k
perforaci cévy nebo ke krvácení.
14) Jakmile katetr UltraStream a vztunprostedek správnumístíte do cévy (za pouití skiaskopické vizualizace),
odjistte vztunprostedek a vodicí drát a opatrnje vyjmte z katetru.
15) K jedné prodluovací hadice pipojte 20ml stíkaku a otevete svorku. Krev by mla jít snadno natáhnout. Po
vytvoení adekvátního prtoku krve propláchnte lumen, poté znovu zasvorkujte prodluovací hadiku a
odstrate stíkaku. Tento krok zopakujte pro druhou prodluovací hadiku katetru.
UPOZORNNÍ: Zabrate vzduchové embolii tak, e budete hadiky katetru udrovat vdy zasvorkované,
pokud se nebudou pouívat, a ped pouitím katetr propláchnete sterilním normálním nebo heparinizovanm
fyziologickm roztokem. Po kadé vmnspojky hadiek vypláchnte vzduch z katetru a ze vech pípojnch
hadiek a uzávr.
UPOZORNNÍ: Ke svorkování prodluovacích hadiek pouívejte vhradnvazené svorky, které byly dodány
s katetrem UltraStream. Nepouívejte kleta nesvorkujte distální ást katetru.
POZNÁMKA: Pociujete-li pi aspiraci krve nadmrnodpor, katetr me bt teba otoit, propláchnout nebo
pemístit za úelem udrení adekvátního prtoku krve. V systému také me bt pítomna stávající fibrinová zátka.
16) Naplte 20ml stíkaku sterilním normálním nebo heparinizovanm fyziologickm roztokem, pipojte ji na jednu z
prodluovacích hadiek katetru, otevete svorku a propláchnte lumen. Po propláchnutí lumen znovu zasvorkujte
prodluovací hadiku a odstrate stíkaku. Tento krok zopakujte pro druhou prodluovací hadiku katetru.
17) Po umístní katetru pipevnte ke spojkám Luer injekní uzávry.
18) Pokud se katetr nebude ihned pouívat k léb, vytvote v kadém katetru heparinovou zátku podle standardního
protokolu. Dalí poznámky viz ást Heparinizace.
19) Ihned po zavedení potvrte pomocí skiaskopické vizualizace správné umístní hrotu katetru. Hrot katetru se musí
umístit na úrovespojení duté íly a sínnebo do pravé sín, aby byl zajitn optimální prtok krve (podle
doporuení aktuálních pokynNKF/KDOQI). VDY PO UMÍSTNÍ KATETRU PIPEVNTE KE SPOJKÁM LUER
KATETRU OBA INJEKNÍ UZÁVRY.
UPOZORNNÍ: Zanedbání kroku ovení polohy katetru me mít za následek závané poranní nebo smrtelné
komplikace.
20) V pípadpoteby zaijte místo vstupu tunelu nebo místo zavedení do cévy. Katetr piijte k pokoce pomocí
pevnch icích kidélek. Nepiívejte hadiku katetru.
21) Pilote dodané krytí podle protokolu zdravotnického zaízení.
19
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