Denver Ascites Shunt PAK 42-2050/42-2055 - CareFusion

More documents

Recommendations

Info

en Shunt Description The Denver Peritoneo-Venous Shunt (Figure 1) consists of a fenestrated peritoneal catheter, a venous catheter, and a flexible pump chamber containing either one or two miter valves. The heart of the system is the valved pump chamber. When the pressure in the peritoneal cavity is approximately 3 cm water higher than the central venous pressure, the valves open and permit flow through the shunt. In a double-valved shunt, the second valve serves as a check valve which helps prevent reflux of blood into the distal end of the venous catheter when the unit is manually pumped. In a single-valved shunt, reflux is prevented by manual occlusion of the venous catheter. The valves are made deliberately asymmetrical, causing them to be self-cleaning. Figure 1: Peritoneo-venous Shunts The entire device is constructed from medical-grade silicone rubber. No connections at surgery are required. The venous tubing may be shortened for optional positioning in the superior vena cava and the peritoneal catheter may be shortened for the best placement in the peritoneal cavity. An integral barium sulfate stripe in the wall of the peritoneal and venous catheters permits visualization by fluoroscopy or with a roentgenogram to confirm proper positioning at the time of surgery. Silique, a unique surface treatment, has been applied to the shunts. This treatment provides a smoother, less tacky surface with a lower coefficient of friction. Silique surface treatment is a permanent treatment that will not leach, wear, or flake off. Silique surface treatment does not change the bulk physical properties of silicone and therefore does not change the strength, flexibility, or flow properties of the shunt. The flow rate for each shunt is determined using water as the working media. All flow rates are determined at a temperature of 70º F with a head pressure of 10 cm. Flow rates tend to increase as fluid temperature increases. Flow rates tend to decrease as the fluid becomes more viscous. Indications Peritoneo-venous shunting is indicated for patients with: • chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management. • persistent ascites who are not considered candidates for portal-venous shunting. • persistent ascites that is non-responsive to standard medical management. • primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intraabdominal pressure. Venous Catheter 0.39 cm OD 66 cm 0.23 cm ID (11.5 Fr.) Caution: Benefits of instituting peritoneo-venous Radiopaque Stripe shunting in patients with neoplastic ascites should be weighed against the potential hazards of Second One- Way Valve dissemination of ascitic fluid containing malignant Suture Pad cells. First One- Way Valve Peritoneo-venous shunting should also be Radiopaque considered for patients with hepatorenal syndrome, Stripe chylous ascites and idiopathic ascites. Peritoneal Catheter 0.51 cm OD Contraindications 0.27 cm ID Peritoneo-venous shunting is (15.5 contraindicated Fr.) for 27 cm patients with: • peritonitis 7.7 cm • possible non-sterile ascitic fluid or intra-abdominal infection Pump Chamber • acute tubular necrosis or primary renal failure • extremely high bilirubin and /or creatinine levels In general, shunting should be avoided in the presence of any systemic infection. Patients with a recent history of gastrointestinal bleeding should be evaluated for portal hypertension. Correction of the portal hypertension should be considered prior to insertion of a peritoneo-venous shunt. The presence of marginal cardiac function is a relative contraindication to shunt placement for those patients who may not tolerate the increased circulatory load associated with peritoneo-venous shunting. Use of the subclavian vein for catheterization is not recommended for individuals who may require the construction of a permanent venous access for hemodialysis. Thrombosis or severe stenosis of the subclavian vein, which may result from the presence of the venous catheter, is not compatible with an A-V fistula in the ipsilateral arm. 66 cm (11.5 Fr.) (15.5 Fr.) 27 cm 1
Warnings Particulate matter or venous thrombosis may cause shunt occlusion, necessitating revision or replacement of the shunt. Resistance to compression of the pump chamber may be an indication that the venous catheter or pump chamber is occluded. Should the pump chamber fail to refill readily, the peritoneal catheter may be occluded. (See Testing Shunt Function on Page 7) Never inject directly into the tubing portion of the shunt, as leakage or tearing of the catheter may occur. Wipe the venous catheter with a sterile solution immediately prior to insertion into the vein, taking care that no blood products remain on the catheter. Because maximum fluid flow occurs when there is the greatest difference in pressure between the peritoneal and venous ends of the shunt, it is advisable to minimize the time the patient is supine immediately after shunt placement to avoid fluid overload. (See Postoperative Management on page 6) The insertion point into the subclavian vein must be carefully chosen. If the catheter is inserted too far medially, compression between the clavicle and the first rib may lead to decreased flow or severing the venous end of the shunt. To avoid blood reflux into the venous catheter when pumping the single-valved shunt, it is important for the patient to be in a supine position. After compressing the pump catheter but before releasing it, the venous catheter should be occluded by pressing or pinching it through the skin. The peritoneo-venous shunt is only intended for peritoneo-venous use. Cautions For single use only. Re-use may result in a non-functional product or contribute to cross contamination. Use sterile technique in all phases of the use of this product. Individual patient anatomy and physician technique may require procedural variations. Benefits of instituting peritoneo-venous shunting in patients with neoplastic ascites should be weighed against the potential hazards of dissemination of ascitic fluid containing malignant cells. Exercise extreme care to prevent the shunt from coming in contact with bare fingers, towels, drapes, talc, or any linty or granular surfaces. Silicone rubber is highly electrostatic and, as a result, attracts airborne particles and surface contaminants that could produce tissue reaction. Use rubber-shod instruments when handling the shunt. Possible cuts or tears can occur if rubbershod instruments are not used. Avoid excessive handling of the shunt. Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures. Confirm shunt patency prior to insertion. Prime the shunt prior to insertion to eliminate large air bubbles from the chamber and catheters. (See Preparation of the Shunt on page 3.) This device should only be used by physicians thoroughly trained in the technique of percutaneous access of the subclavian vein. Care should be taken when draining ascites, as rapid evacuation of ascitic fluid may result in circulatory or vascular collapse. It is important to use an oblique approach while passing through the peritoneum, to minimize the chance of ascitic fluid leakage. Do not allow the guidewire to inadvertently advance totally within the patient. It is very important to peel the sheath away from the catheter in a symmetrical manner. If the catheter begins to withdraw while the sheath is being peeled, hold the catheter in place and carefully peel the sheath away symmetrically. Do not use forceps on the introducer to break its handle and/or peel the sheath. The peel-away sheath should withdraw freely from the body. If resistance is encountered, do not force the peeling action of the sheath or its withdrawal. Make procedural corrections, then continue. Damage to or embolization of the guidewire may result if it is withdrawn through the needle. Do not use introducers or guidewires that differ in size from the components supplied in the kit. Insertion into artery may cause excessive bleeding and/or other complications. Potential complications of percutaneous insertion include, but may not be limited to pneumothorax, hematoma formation, brachial plexus injury, injury to mediastinal or visceral structures, sepsis/infections, excessive bleeding, and vessel damage. Individual patient anatomy, such as a thin, weak abdominal wall, may require procedural variations to reduce the risk of leakage around the catheter. Individual patient anatomy, such as obesity or loose subcutaneous tissue, may require procedural variations to reduce the risk of inadvertent catheter withdrawal from the vein. In patients with peritoneo-venous shunts, care must be taken to avoid air entering the shunt when laparoscopic surgery or abdominal endoscopic procedures are performed. Peritoneal fibrosis has been observed in some patients with peritoneo-venous shunts. Repairing hernias before shunt insertion and promptly treating intra-abdominal inflammation may reduce the risk of this complication. 2
Page 1: 42-2050/42-2055 Denver Ascites Shun
Page 5 and 6: Obtaining Venous Access Fluoroscopy
Page 7 and 8: Warning: Wipe the venous catheter w
Page 9 and 10: Description du shunt Le shunt péri
Page 11 and 12: Stérilité Ce produit a été sté
Page 13 and 14: ATTENTION : Pour réduire au maximu
Page 15 and 16: Entretien du shunt Pour éviter la
Page 17 and 18: Warnhinweise Blut- und Gewebeartike
Page 19 and 20: Venöser Zugang Für dieses Verfahr
Page 21 and 22: 3. Dilatator aus der Hülle herausz
Page 23 and 24: it Descrizione dello shunt Lo shunt
Page 25 and 26: Sterilità Questo prodotto è stato
Page 27 and 28: PRECAUZIONE: Nel passare attraverso
Page 29 and 30: PRECAUZIONE: Nei pazienti con shunt
Page 31 and 32: Advertencias La presencia de partí
Page 33 and 34: Obtención de la vía venosa En la
Page 35 and 36: 2. Introduzca el dilatador de venas
Page 37 and 38: pt Descrição do Shunt O Shunt Per
Page 39 and 40: Esterilidade Este produto foi ester
Page 41 and 42: Atenção: É importante utilizar u
Page 43 and 44: Manutenção do shunt Para ajudar a
Page 45 and 46: Waarschuwingen Deeltjes of veneuze
Page 47 and 48: Veneuze toegang krijgen Er dient fl
Page 49 and 50: Waarschuwing: Veeg de veneuze kathe
Page 51 and 52: sv Shuntbeskrivning Denver peritone
Page 53 and 54:
Sterilitet Denna produkt är steril
Page 55 and 56:
3. Efter inträdet i peritonealhål
Page 57 and 58:
Underhåll av shunt För att bidra
Page 59 and 60:
Advarsler Partikulært stof eller v
Page 61 and 62:
Sådan opnås adgang til venen Genn
Page 63 and 64:
Advarsel: Aftør det venøse katete
Page 65 and 66:
fi Suntin kuvaus Denver-vatsaontelo
Page 67 and 68:
Steriiliys Tämä tuote on steriloi
Page 69 and 70:
3. Työnnä neulaa vatsakalvonontel
Page 71 and 72:
kaksikymmentä kertaa potilaan olle
Page 73 and 74:
Advarsler Partikkelmaterialer eller
Page 75 and 76:
Å få til venøs tilgang Det er n
Page 77 and 78:
4. Ta av klemmen fra venekateteret
Page 79 and 80:
el Περιγραφή αναστό
Page 81 and 82:
Είναι σηµαντικό να
Page 83 and 84:
3. Αναισθητοποιήστε
Page 85 and 86:
8. Συνίσταται να σηµ
Page 87 and 88:
Προειδοποίηση: Για
Page 89 and 90:
警告粒状物質や静脈
Page 91 and 92:
注意 : 腹水を急速に
Page 93 and 94:
5. トンネラーをカテーテ
Page 95:
3. 上大静脈に血栓が
show all

Denver Ascites Shunt PAK 42-2050/42-2055 - CareFusion

Create successful ePaper yourself

Delete template?

Save as template?