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.

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

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.

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

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

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)

BULGARIAN

:

         .   ,  

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        /     , ,

  ,     ,     .  ,

            

 /        , ,   ,

   ()     .     

  ,     .     

           .

 :

(1)  UltraStream 15,5 Fr

(1)   



(1)    



(1)   16 Fr

(1)  

(1)    18 Ga x

7 

(1)  

(2)  

(2)  

    

:

(1)  UltraStream 15,5 Fr

(1)    

  

  

(1)    



(1)   16 Fr

(1)  

(1)    18 Ga x

7 

(1)   0,038 

(0,97 )  80 

(1)  

(2)  

(2)  

(1)   



  :

(1)  UltraStream 15,5 Fr

(1)   



(2)  

  

      UltraStream     

   ,            

  .          

  .      ,      

 .         ,    

      .      ,    

     .

-     –        

UltraStream.

  

      UltraStream     

 .



   , :

•        ,   ,  

 .

•       .

•      .

•             

 .

•       /   .

, /

, mmHg

"%

•46&*. 45&734788& 48 .-1&)&3+ 3& # (.697 3& =4(+0&8& .2933& 3+*478&8=3478) .1. *69).

56+3&73. 54 06(+3 585&84)+3., 2+*.<.370.8+ 6&'483.<. 6+*4(34 86'(& *& .-541-(&8 4'456.+8.

56+*5&-3. 2+60. 4834734 06(8& .8+1+73.8+ 8+=3478. 56. )6.,&8& -& (7.=0. 5&<.+38.. 4 (6+2+ 3&

6&'48&8& 797864/78(484 786.0834 86'(& *& 7+ 75&-(& 78+6.13& 8+;3.0&.

•& *& 7+ .-'+)3+ (-*93& +2'41., 0&8+868(.3&). 86'(& *& '*+ 01&25.6&3, 04)&84 3+ +7(6-&3

77756.3<4(0. .1. 06(3. 1.3...

•+ .-541-(&/8+ &<+843 .1. /4*4(. 6&-8(46. (8.30896.) 3& &104;413& 4734(& (6;9 0484 .*& +=&78 48

86'.8+ 3& 0&8+86&. 438&08878+-. (++78(& 24,+ *& 9(6+*. 0&8+86&. & 4'6&'480& 3& .-;4*3484

2784 7+ 56+546=(& 54(.*43-/4* 3& (4*3& 4734(&.

•+1+3.8(4*&= (.3&). 86'(&*& '*+ *.78&134 3& (6;& 3& )(0&(484 97864/78(4 -& 54**6,0& 54

(6+2+ 3& ((+,*&3+84 3& 0&8+86&.

•&8+86886'(& *& '*+ 56.*(.,(&3 3&56+* 7&24 3&* 8+1+3 (4*&=.

#  

•+ .-541-(&/8+ 0&8+86&, &04 (6;9 3+)4 .1. 042543+38.8+ 29 7+ -&'+1-(&8 0&0(.84 .*& 7& 56.-3&<.

3& 9(6+,*&3+ (&04 7& 4)3&8., 72&=0&3., 76-&3. .8.3.).

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;,:0/</  ;/.78 8< =.50/72<* 7* 4*</<:*, 8<,8:/</ 45*69*<* 29:8623</ 5=6/7*. '86 4*<8 5=6/7*

+./ 9:862<, 45*692:*3</ 8<78,8 =.502</57*<* <:+* 26*?7/</ ;9:27@8,4*<*. !8,<8:/</ <*12 ;<94*

1* .:=-*<* =.502</57* <:+* 7* 4*</<:*.

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,,,/:2-*<* 21,7<58<8.

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7* <*4,5/4*:, 680/ .* ,,/0.*, :*+8<2 ;221,*0.* 4*</<:* 1* 9:8.502</57* =98<:/+* 9:2 ?/68.2*521*

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8<+/5/0/</ 6*:42:8,42</ 1* .5+8A27* ,:?= </5/72 ,8.*A.

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11) *( &.* +*'*"!)$!.* 6 ! +*.6, !)*, )* $# !.! 0,035/0,038 $)3*$8 (0,89/0,97 (() .!'!)

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&'(+.

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/ 6'"$.!') .,6 ) &.!.6,.

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 :

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# +!,-*)'. ,!,6#&$.! # ,)$ .,8  -! +* 6,". -/1$. 2$!).6. )! .,8  +'/,  #!( /4 $'$

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+,$ -.!,$')$ /-'*$8.

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)!# **'$.!'!) &,6*.*& $/$'$ -$')* -6+,*.$'!)$! +* ,!(! ) 1!(* $'$#.. ,$3$)$.! (*"! 

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*+$.%.!  -+$,$,.! -6-$,!& -6- -+,$)2*&. &* -+$,2$8. )! /-+!!, '!&,8. (*"!  +,!2!)$ '$ 

$#+*'# ,#.*, (.6&)!) +'#($)*!)!) &.$.*,, ..!. TPA), #  ,#.*,$ -6-$,!&.



-** !.! ()4!. *. .6&). +,! $ $#" )!. '! $#" )! ) &.!.6,, +,$.$-)!.! -,6& (8-.*.* )

+/)&2$8., #  &*).,*'$,.! &,6*.!3!)$!.*. .*,!.! $)2$#$8. -4! #$-$(*-. *. )/" $.!. '! .*

+*-.!.!  1!#$) +,!,6#& # ,)$.

:*.* $#" .! &.!.6,,  $#+*'#%.! ,!#&$ $"!)$8 $'$ +,!&*(!,) -$'; .*

(*"!  *! ! * -&6-)! ) &.!.6,.

 

.!.,$.! # +,* 6'"$.!') /+*.,! +,$ 1!(* $'$# UltraStream - -.!,$'$#$,)$ 3,!# # ) !.$'!)* *&$-.

6 6,")$!.* !-.!,$')* $+$,*!))* )!*.*,!) $)!+*,! !) *+&*&. ! $#+*'#%.! &.!.6,, &*

*+&*&. !+*,! !) $'$ !$' *.,8).

&

61,)8%.! +,$ -.%) &*).,*'$,) .!(+!,./,. ! $#'%.! ) *,)$3)$ ,#.*,$.!'$, %*)$#$,5

, $2$8 $'$ /'.,$*'!.* -!.'$). * (!)8%.! $)!).,, .& 3! &.!.,$.!  6 . $#+*'#)$ +,! $

$#.$3)! ) -,*& ) * )*-. 6,1/ !.$&!. ) *+&*&..

%

•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 *

./'&.

,.!,$'!) *!( !)*#!) *!(

24 -( 2,6 (' 1,6 ('

28 -( 2,8 (' 1,8 ('

32 -( 3,0 (' 2,0 ('

36 -( 3,2 (' 2,2 ('

40 -( 3,6 (' 2,4 ('

55 -( 4,6 (' 3,0 ('

CZECH

Varování:

Ureno pouze k jednomu pouití u jednoho pacienta. Nepouívejte opakovan, nerenovujte, neresterilizujte.

Opakované pouití, renovace nebo resterilizace me ohrozit strukturální integritu prostedku a/nebo vést k selhání

prostedku, které me následnzpsobit zranní, onemocnní nebo smrt pacienta. Opakované pouití, renovace nebo

resterilizace me zpsobit také riziko kontaminace prostedku nebo me zpsobit infekci i kíovou infekci vetn

penosu infekních onemocnní z jednoho pacienta na druhého, ale i dalí potíe. Kontaminace prostedku me mít za

následek poranní, onemocnní nebo smrt pacienta. Podle federálních zákonUSA smí tento prostedek pouívat pouze

lékanebo osoba pod dohledem lékae.

Standardní souprava:

(1) Katetr UltraStream 15,5 French

(1) Flexibilní vztunprostedek

(1) Tunelátor

(1) Cévní dilatátor 16 French

(1) Bezpenostní skalpel

(1) Zavádcí jehla 18 G x 7 cm

(1) Bezpenostní pna

(2) Adhezivní krytí

(2) Injekní uzávry

Souprava Peel Away:

(1) Katetr UltraStream 15,5 French

(1) Zavad Peel Away s ventilem

(1) Tunelátor

(1) Cévní dilatátor 16 French

(1) Bezpenostní skalpel

(1) Zavádcí jehla 18 G x 7 cm

(1) Vodicí drát 0,038 palce

(0,97 mm) x 80 cm

(1) Bezpenostní pna

(2) Adhezivní krytí

(2) Injekní uzávry

(1) Flexibilní vztunprostedek

Náhradní souprava:

(1) Katetr UltraStream 15,5 French

(1) Flexibilní vztunprostedek

(2) Injekní uzávry

Popis prostedku

Permanentní hemodialyzaní katetr UltraStream je permanentní vícelumennrentgenokontrastní polyuretanovkatetr

opatenpolyesterovou manetou a dvma aretaními adaptéry Luer s vnitním závitem. Maneta podporuje

prorstání tkánza úelem upevnní katetru v subkutánním tunelu. Aretaní adaptéry Luer jsou barevnoznaeny,

take lze rozliit arteriální a venózní lumeny. ervenadaptér Luer oznauje arteriální odtok z tla pacienta a modr

adaptér Luer oznauje ilní návrat do tla pacienta. Kadá svorka má navíc títek, kterje oznaen odpovídajícím

plnicím objemem.

Níe je znázornno srovnání profilu prtoku a tlaku permanentního hemodialyzaního katetru UltraStream.

Indikace

Permanentní hemodialyzaní katetr UltraStream je uren k pouití pi trvalé hemodialze a aferéze.

Kontraindikace

Pouití prostedku je kontraindikováno v následujících pípadech:

•Vskyt infekcí souvisejících s jinm prostedkem, podezení na bakterémii nebo septikémii i potvrzená

bakterémie i septikémie.

•Stávající závané chronické obstrukní onemocnní plic.

•Postradiace místa plánovaného zavedení prostedku.

•Epizody ilní trombózy v anamnéze nebo pokud v minulosti dolo k cévním chirurgickm vkonm v oblasti

plánovaného umístní prostedku.

•Lokální faktory tkánbránící správné stabilizaci a/nebo pístupu prostedku.

Varování

•Vzhledem k riziku expozice HIV (virus lidské imunodeficience) i jinm patogenm penáenm krví je vhodné,

aby zdravotnickpersonál pi péi o vechny pacienty rutinndodroval obecná ochranná opatení vhodná pi

práci s krví a s tlními tekutinami. Pi vekeré manipulaci s prostedkem se musí písndodrovat sterilní postupy.

•Zabrate vzduchové embolii – zasvorkujte katetr vdy, kdy není pipojen ke stíkakám nebo ke krevním linkám.

•Na ádnou ást hadiek katetru neaplikujte aceton ani roztoky jodu na bázi alkoholu (tinktury). Takové látky

mohou svm psobením pokodit katetr. Místo vstupu se doporuuje oetovat betadinem na vodní bázi.

•Vodicí drát musí bt bhem zavádní katetru vdy distálnvi hrotu vztuného prostedku.

•Katetr se musí posouvat pouze po vodicím drátu.

Veobecná upozornní

Prtok (ml/min)

Tlak (mmHg)

•Pokud katetr nebo komponenty vykazují jakékoli známky pokození (nap. jsou-li ohnuté, promáknuté, poezané

atd.), nepouívejte je.

•V blízkosti prodluovacích hadiek nebo tubusu katetru nepouívejte ostré nástroje. K odstranní krycího materiálu

nepouívejte nky, nebotak vzniká riziko pestiení nebo pokození katetru. ádnou ást katetru neproívejte

stehy. Pokud se k zajitní katetru pouívají stehy, musíte pouít kidélko pro piití. Pokud na hadiky katetru

psobí nadmrná síla nebo pokud se hadiky dotkají drsnch okraj, mohou se roztrhnout.

•Bhem implantace katetr neohbejte pod ostrmi úhly, protoe by se tím mohla pokodit jeho funknost.

•Ped zavedením katetru prostedek naplte sterilním heparinizovanm fyziologickm roztokem nebo normálním

fyziologickmroztokem za úelem potlaení rizika vzduchové embolie.

•Propláchnutí ucpaného lumen se nesmí provádt nadmrnou silou. Nepouívejte stíkaku mení ne10 ml.

•Kvli prevenci nehod zkontrolujte ped zahájením oetení a mezi jednotlivmi oeteními bezpenost vech

uzávra spojek krevních linek.

•S permanentním hemodialyzaním katetrem UltraStream se doporuuje pouívat pouze písluenství a

komponenty Luer lock opatené závitem. Pi opakovaném utahování krevních linek, stíkaek a uzávrpíli

velkou silou se zkracuje ivotnost spojky a me dojít i k jejímu selhání. asto kontrolujte, zda katetr není

pokrában, oden, naíznutatd. a zda tak není zhorena jeho funknost.

•Opakovanm svorkováním prodluovací hadiky na stejném místse hadika me zeslabit. Za úelem

prodlouení ivotnosti hadiky pravidelnmte polohu svorky. Svorku neumísujte v blízkosti adaptéru a

ústí katetru. Nesvorkujte tubus katetru. Pouívejte vhradnsvorky prodluovacích hadiek, které byly dodány

s katetrem. Na konci kadého oetení zkontrolujte, zda nejsou hadiky pokozené.

Moné komplikace

•vzduchová embolie;

•perforace cévy;

•hemorragie;

•endokarditida;

•bakterémie;

•pneumotorax;

•hemotorax;

•infekce místa vstupu;

•krvácení;

•subkutánní hematom;

•zánty;

•nekróza místa vstupu;

•poranní brachiálního plexu;

•poranní hrudního mízovodu;

•lacerace cévy;

•vytvoení fibrinové zátky;

•srdení arytmie;

•chorobnstav tunelu;

•trombóza lumen/cévy;

•hematom;

•srdení tamponáda;

•vaskulární trombóza;

•smrt.

Místa zavedení

Permanentní hemodialyzaní katetr UltraStream lze zavést perkutánna v ideálním pípadumístit do jugulární íly.

Pestoe lze tento katetr umístit i do podklíkové íly, je preferováno umístní do vnitní jugulární íly (podle pokynu 5

iniciativy Národní nadace pro onemocnní ledvin [National Kidney Foundation Dialysis Outcomes Quality Initiative –

NKF/KDOQI], aktualizace NKFKDOQI 2006).

Upozornní

•U pacient, u nichje nutná podpora ventilace, je zvené riziko pneumotoraxu pi kanylaci podklíkové íly.

•Dlouhodobé pouívání podklíkové íly me bt spojeno se stenózou podklíkové íly.

Pokyny pro zavedení katetru (standardní souprava)

Zavádní a odstranní permanentního hemodialyzaního katetru UltraStream a manipulaci s ním má provádt pouze

kvalifikovanlékanebo jinoprávnnkvalifikovanzdravotnickpracovník pod dohledem takového lékae. Lékaské

techniky a procedury popsané v tchto pokynech nepedstavují vechny lékasky akceptovatelné protokoly ani nejsou

ureny jako náhrada za lékaskou zkuenost a odborné posouzení pi lébkonkrétního pacienta.

Upozornní: Bhem pístupu, provádní údrby a vyjímání písndodrujte aseptickou techniku.

1) Vyberte vhodnou délku katetru, abyste dosáhli správného umístní hrotu. Správnvbr délky katetru je

dleita bude záviset na anatomii pacienta.

POZNÁMKA: Kvli usnadnní aplikace krytí na místo vstupu a kvli komfortu pacienta umístte vstup tunelu

pod klíní kost. Tunely vedené v irokém mírném oblouku sniují riziko zauzlování katetru. Tunel musí bt

dostatenkrátk, aby ústí katetru ve tvaru Y nemohlo vstoupit do místa vstupu; zárovemusí bt tunel

dostatendlouh, aby udrel manetu nejmén2 cm od otvoru v pokoce.

2) Aplikujte dostatené mnoství lokálního anestetika, aby se zcela anestetizovala oblast zavedení a tunel.

3) Pomocí mikropunkního zavádcího systému nebo ekvivalentu vytvote perkutánní pístup do zvolené íly.

4) Po vytvoení pístupu nahrate zavádcí 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.

UPOZORNNÍ: Délka zavedeného vodicího drátu závisí na velikosti pacienta. Bhem tohoto postupu sledujte,

zda pacient nevykazuje známky arytmie. Bhem tohoto postupu se pacient musí napojit na monitor srdení

innosti. Pokud necháte vodicí drát proniknout do pravé sínnebo komory, mohou se vyskytnout srdení arytmie.

Bhem tohoto postupu se musí vodicí drát pevndret.

UPOZORNNÍ: Pouíváte-li zavádcí jehlu, nevytahujte vodicí drát proti zkosení jehly, aby nedolo k peíznutí

vodicího drátu.

5) Propláchnte dilatátor sterilním normálním nebo heparinizovanm fyziologickm roztokem a zavete jej po

vodicím drátu o velikosti 0,035 palce (0,89 mm) nebo 0,038 palce (0,97 mm), kterse nachází v míst

venotomie. Dilatátor se me ponechat na míst.

6) Vytvote malou incizi v hrudní stnna pedem ureném místvstupu; incize musí bt dostateniroká,

aby se pizpsobila polyesterové manetkatetru a dlouhá cca 1 cm.

7) Pipravte k zavedení katetr UltraStream a flexibilní vztunprostedek: jemnotete exponovanou distální

ást sterilním normálním nebo heparinizovanm fyziologickm roztokem a propláchnte vechny lumeny

pomocí 10ml stíkaek naplnnch normálním nebo heparinizovanm fyziologickm roztokem.

8) Pomocí dodané barevnoznaené vazené svorky zasvorkujte pouze ervenou (arteriální) prodluovací

hadiku a odstrate stíkaku. K ilnímu hrotu katetru UltraStream pipojte tunelátor z nerez oceli. Zabrate

pokození hrotu katetru bhem umísování. Na katetr UltraStream nasute ochrannsheath tak, aby zcela

pekryl hrot katetru. Posunujte flexibilní vztunprostedek do ilní spojky Luer, ase hrot vztuného

prostedku jemndotkne tunelátoru z nerez oceli.

POZNÁMKA: Bhem tunelování pomocí katetru nebude ilní spojka Luer na vztuném prostedku propojena

se spojkou Luer na katetru UltraStream.

9) Pomocí zúeného hrotu tunelátoru provete tupou disekci a vytvote subkutánní tunel s poátkem v míst

vstupu a koncem v místvenotomie/dilatátoru.

UPOZORNNÍ: Tunel nesmí procházet skrz sval. Tunel je nutno vytváet etrn, aby se zabránilo pokození

okolních cév a nerv.

10) Protáhnte katetr UltraStream subkutánním traktem. Proximální ást katetru dejte do polohy umoující

umístní standardní polyesterové manety (cca 2 cm uvnittraktu).

11) Opatrnvyjmte tunelátor z katetru UltraStream. Posute vztunprostedek, aby bylo moné utáhnout a

zajistit spojku Luer s katetrem UltraStream.

12) Kvli prevenci krvácení udrujte tlak nad místem pístupu do cévy. Vyjmte dilatátor; vodicí drát o velikosti

0,035 palce (0,89 mm)/0,038 palce (0,97 mm) ponechte na míst. Technikou „backload“ zavete vodicí drát

do distálního lumen vztuného prostedku katetru UltraStream.

13) Posunujte katetr UltraStream a flexibilní vztunprostedek po proximální ásti vodicího drátu o velikosti

0,035 palce (0,89 mm) nebo 0,038 palce (0,97 mm) skrz subkutánní tkádo cévy, ado okamiku, kdy

skiaskopicky potvrdíte správné umístní hrotu katetru. Narazíte-li na odpor, mete zavádní usnadnit dalí

tupou disekcí. Arteriální lumen oznaenervenou spojkou Luer lock doporuujeme orientovat smrem k hlav

(kdyje katetr umístn na pravé stranpacienta). Pokud se katetr umístí na levou stranu pacienta, musí se

ilní lumen oznaenmodrou spojkou Luer lock umístit tak, aby smoval k hlav. Tím se zajistí, aby arteriální

lumeny umístné v pravé síni smovaly k mediastinu (podle pokyn2006 NKF/KDOQI).

UPOZORNNÍ: Katetr a vztunprostedek neposouvejte za hrot vodicího drátu, neboby mohlo dojít k

perforaci cévy nebo ke krvácení.

14) Jakmile katetr UltraStream a vztunprostedek správnumístíte do cévy (za pouití skiaskopické vizualizace),

odjistte vztunprostedek a vodicí drát a opatrnje vyjmte z katetru.

15) K jedné prodluovací hadice pipojte 20ml stíkaku a otevete svorku. Krev by mla jít snadno natáhnout. Po

vytvoení adekvátního prtoku krve propláchnte lumen, poté znovu zasvorkujte prodluovací hadiku a

odstrate stíkaku. Tento krok zopakujte pro druhou prodluovací hadiku katetru.

UPOZORNNÍ: Zabrate vzduchové embolii tak, e budete hadiky katetru udrovat vdy zasvorkované,

pokud se nebudou pouívat, a ped pouitím katetr propláchnete sterilním normálním nebo heparinizovanm

fyziologickm roztokem. Po kadé vmnspojky hadiek vypláchnte vzduch z katetru a ze vech pípojnch

hadiek a uzávr.

UPOZORNNÍ: Ke svorkování prodluovacích hadiek pouívejte vhradnvazené svorky, které byly dodány

s katetrem UltraStream. Nepouívejte kleta nesvorkujte distální ást katetru.

POZNÁMKA: Pociujete-li pi aspiraci krve nadmrnodpor, katetr me bt teba otoit, propláchnout nebo

pemístit za úelem udrení adekvátního prtoku krve. V systému také me bt pítomna stávající fibrinová zátka.

16) Naplte 20ml stíkaku sterilním normálním nebo heparinizovanm fyziologickm roztokem, pipojte ji na jednu z

prodluovacích hadiek katetru, otevete svorku a propláchnte lumen. Po propláchnutí lumen znovu zasvorkujte

prodluovací hadiku a odstrate stíkaku. Tento krok zopakujte pro druhou prodluovací hadiku katetru.

17) Po umístní katetru pipevnte ke spojkám Luer injekní uzávry.

18) Pokud se katetr nebude ihned pouívat k léb, vytvote v kadém katetru heparinovou zátku podle standardního

protokolu. Dalí poznámky viz ást Heparinizace.

19) Ihned po zavedení potvrte pomocí skiaskopické vizualizace správné umístní hrotu katetru. Hrot katetru se musí

umístit na úrovespojení duté íly a sínnebo do pravé sín, aby byl zajitn optimální prtok krve (podle

doporuení aktuálních pokynNKF/KDOQI). VDY PO UMÍSTNÍ KATETRU PIPEVNTE KE SPOJKÁM LUER

KATETRU OBA INJEKNÍ UZÁVRY.

UPOZORNNÍ: Zanedbání kroku ovení polohy katetru me mít za následek závané poranní nebo smrtelné

komplikace.

20) V pípadpoteby zaijte místo vstupu tunelu nebo místo zavedení do cévy. Katetr piijte k pokoce pomocí

pevnch icích kidélek. Nepiívejte hadiku katetru.

21) Pilote dodané krytí podle protokolu zdravotnického zaízení.

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